As filed with the Securities and Exchange Commission on April 26, 2023
Registration No. 333-269741
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 4
TO
FORM S-4
REGISTRATION STATEMENT
Under
The Securities Act of 1933
Angion Biomedica Corp.
(Exact name of Registrant as specified in its charter)
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Delaware
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2834
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11-3430072
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(State or Other Jurisdiction of
Incorporation or Organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification Number)
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7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
(Address, including zip code, and telephone number, including area code, of
Registrant’s principal executive offices)
Jay R. Venkatesan, M.D.
President and Chief Executive Officer
Angion Biomedica Corp.
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
(Name, address, including zip code, and telephone number, including area code, of
agent for service)
Please send copies of all communications to:
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Kenneth L. Guernsey
Brett D. White
Anitha Anne
Cooley LLP
Three Embarcadero Center,
20th Floor
San Francisco, CA 94111
(650) 843-5000
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Jennifer J. Rhodes
General Counsel
Angion Biomedica Corp.
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
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Kristen Ferris
Goulston & Storrs PC
400 Atlantic Ave
Boston, MA 02110
(617) 482-1776
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William C. Hicks
Daniel A. Bagliebter
Mintz Levin Cohn Ferris
Glovsky & Popeo, P.C.
One Financial Center
Boston, MA 02111
(617) 542-6000
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Approximate date of commencement of proposed
sale to the public: As soon as practicable after the effectiveness of this registration statement and the satisfaction or waiver of all other conditions under the Merger Agreement described herein.
If the securities being registered on this Form are being offered
in connection with the formation of a holding company and there is compliance with General Instruction G, please check the following box. ☐
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule
462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☒
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Smaller reporting company
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☒
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Emerging growth company
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☒
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
If applicable, place an X in the box to designate the appropriate rule
provision relied upon in conducting this transaction:
Exchange Act Rule 13(e)-4(i) (Cross-Border Issuer Tender Offer) ☐
Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer) ☐
The Registrant hereby amends this registration
statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information in this proxy statement/prospectus/information statement is not complete and may be changed. Angion may not sell its securities
pursuant to the proposed transactions until the registration statement filed with the Securities and Exchange Commission is effective. This proxy statement/prospectus/information statement is not an offer to sell these securities and is not
soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY—SUBJECT TO COMPLETION—DATED APRIL 26, 2023
PROPOSED MERGER
YOUR VOTE IS VERY IMPORTANT
To the Stockholders of Angion Biomedica Corp. and Elicio
Therapeutics, Inc.:
Angion Biomedica Corp. (Angion) and Elicio Therapeutics, Inc.
(Elicio) have entered into an Agreement and Plan of Merger and Reorganization, dated January 17, 2023, as may be amended from time to time (Merger Agreement), pursuant to which Arkham Merger Sub, Inc., a Delaware corporation and wholly owned
subsidiary of Angion (Merger Sub), will merge with and into Elicio, with Elicio surviving as a wholly owned subsidiary of Angion (Merger). The Merger will result in a clinical-stage biopharmaceutical company advancing Elicio’s proprietary lymph
node-targeting Amphiphile (AMP) technology to develop immunotherapies, with a focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors.
The Merger will become effective at the time the Certificate of
Merger has been duly filed with the Secretary of State of the State of Delaware or such other date and time as is agreed upon by Angion and Elicio and specified in the Certificate of Merger in accordance with the General Corporation Law of the
State of Delaware (DGCL) (such date, the Closing Date, and such time, the Effective Time). At the Effective Time, each outstanding share of common stock of Elicio (including the shares of common stock issuable upon conversion of all shares of
preferred stock of Elicio prior to the Merger) $0.01 par value per share (Elicio common stock), will be converted into the right to receive approximately 5,719,223 shares of common stock of Angion, $0.01 par value per share (Angion common
stock), based on an assumed exchange ratio of 0.0164, assuming a reverse stock split of Angion common stock at a ratio of 10-for-1 to be implemented prior to the consummation of the Merger as may be adjusted and as discussed in this proxy
statement/prospectus/information statement, and further adjusted based on Angion’s net cash in connection with the closing of the Merger (which net cash is expected to be between $26.5 million and $31.5 million). Angion will assume outstanding
and unexercised options to purchase shares of Elicio common stock, and in connection with the Merger they will be converted into options to purchase shares of Angion common stock based on the agreed upon exchange ratio. At the Effective Time,
Angion’s stockholders will continue to own and hold their then existing shares of Angion common stock, subject to adjustment for the reverse stock split. Each warrant to purchase Elicio common stock outstanding and unexercised immediately prior
to the Effective Time of the Merger will be assumed by Angion and will become a warrant to purchase shares of Angion common stock, with the number of shares and exercise price being adjusted by the same exchange ratio. All outstanding and
unexercised options to purchase shares of Angion common stock will remain effective and outstanding.
Immediately following the Merger, the pre-Merger equity holders
of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each
case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million.
The shares of Angion common stock are currently listed on
The Nasdaq Global Select Market under the symbol “ANGN” although Angion plans to transfer its listing to The Nasdaq Global Market prior to completion of the Merger and Elicio has filed an initial listing application with The Nasdaq Stock
Market LLC (Nasdaq) pursuant to Nasdaq’s “reverse merger” rules. Substantially concurrent with the completion of the Merger, Angion will be renamed “Elicio Therapeutics, Inc.” and expects to trade on The Nasdaq Global Market under the symbol
“ELTX”. On April 25, 2023, the last trading day before the date of this proxy statement/prospectus/information statement, the closing sale price of Angion common stock was $0.75 per share.
Angion is holding a special meeting of stockholders in order
to obtain the stockholder approvals necessary to complete the Merger and other matters. At the Angion annual meeting, which will be held exclusively online via live audio-only webcast on May 31, 2023, at 9:00 a.m. Pacific Time, unless
postponed or adjourned to a later date, Angion will ask its stockholders, among other things, to (i) approve the issuance of shares of Angion common stock as consideration in the Merger and (ii) to approve an amendment to Angion’s certificate
of incorporation effecting a reverse stock split of Angion common stock at a ratio in the range from 5 -for-1 to 30 -for-1, with such specific ratio to be mutually agreed upon by the respective Angion and Elicio boards of directors or, if the
issuance of shares of Angion common stock as consideration in the Merger is not approved by Angion stockholders, at a ratio determined solely by the Angion board of directors (Angion’s Board or the Angion Board) following the special meeting,
each as described in this proxy statement/prospectus/information statement.
Please refer to the various provisions of this proxy
statement/prospectus/information statement for further information with respect to the business to be transacted at the Angion special meeting. As described in this proxy statement/prospectus/information statement, certain of Elicio’s
stockholders are parties to Support Agreements with Angion and Elicio, whereby such stockholders have agreed to vote their shares in favor of the adoption or approval, among other things, of the Merger Agreement and the approval of the
transactions contemplated therein, including the Merger, the issuance of shares of Angion common stock to Elicio’s stockholders, and the change of control resulting from the Merger, subject to the terms of the Support Agreements.
In addition, following the effectiveness of the registration
statement on Form S-4 (Registration Statement), of which this proxy statement/prospectus/ information statement is a part, and pursuant to the conditions of the Merger Agreement and the Support Agreements, Elicio’s stockholders who are party to
the Support Agreements will each execute an action by written consent of Elicio’s stockholders, referred to as the written consent, adopting and approving the Merger Agreement, thereby approving the transactions contemplated therein, including
the Merger. No meeting of Elicio’s stockholders will be held; all of Elicio’s stockholders will have the opportunity to elect to adopt the Merger Agreement, thereby approving the Merger and related transactions, by signing and returning to
Elicio a written consent once this Registration Statement is declared effective by the Securities and Exchange Commission (SEC).
After careful consideration, Angion’s Board has unanimously:
(i) determined that the Merger and the transactions and actions contemplated by the Merger Agreement are fair to, advisable and in the best interests of Angion and its stockholders; (ii) authorized, approved and declared advisable the Merger
Agreement and the transactions contemplated therein, including the Merger, the issuance of shares of Angion common stock to the stockholders of Elicio capital stock pursuant to the terms of Merger Agreement and the treatment of the options and
warrants to purchase Elicio capital stock pursuant to the Merger Agreement; and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Merger Agreement, that the stockholders of Angion vote “FOR” each of the proposals set forth in this proxy statement/prospectus/information statement.
After careful consideration, Elicio’s board of directors
(Elicio’s Board or the Elicio Board) has unanimously (i) determined that the Merger and the transactions and actions contemplated by the Merger Agreement are fair to, advisable and in the best interests of Elicio and its stockholders,
(ii) authorized, and declared advisable the Merger Agreement and the transactions contemplated therein, including the Merger and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Merger Agreement, that
each Elicio stockholder sign and return the written consent, indicating its (a) adoption of the Merger Agreement and approval of the transactions contemplated therein, including the Merger, (b) acknowledgement that the approval given is
irrevocable and that such stockholder is aware of its rights to demand appraisal for its shares pursuant to Section 262 of the DGCL and that such stockholder has received and read a copy of Section 262 of the DGCL, (c) consent to conversion of
Elicio’s preferred stock to Elicio common stock immediately prior to the closing of the Merger, for Elicio’s preferred stockholders, and (d) acknowledgement that by its approval of the Merger such stockholder is not entitled to appraisal rights
or dissenters’ rights with respect to its shares in connection with the Merger and thereby waives any rights to receive payment of the fair value of its capital stock under the DGCL.
More information about Angion, Elicio and the proposed
transaction is contained in this proxy statement/prospectus/information statement. Angion and Elicio urge you to read this proxy statement/prospectus/information statement carefully and in its entirety. In
particular, you should carefully consider the matters discussed under “Risk Factors” beginning on page 20.
Angion and Elicio are excited about the opportunities the
Merger brings to Angion’s and Elicio’s stockholders, and thank you for your consideration and continued support.
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Jay R. Venkatesan, M.D.
President and Chief Executive Officer
Angion Biomedica Corp.
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Robert Connelly
Chief Executive Officer
Elicio Therapeutics, Inc.
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Neither the SEC nor any state securities
commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this proxy statement/prospectus/information statement. Any representation to the contrary is a criminal offense.
This proxy statement/prospectus/information statement is dated
, 2023, and is first being mailed to Angion’s and Elicio’s stockholders on or about , 2023.
7-57 Wells Avenue, Newton, Massachusetts 02459
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
To Be Held On May 31, 2023
Dear Stockholder of Angion:
The board of directors of Angion is pleased to deliver this proxy
statement/prospectus/information statement for the proposed merger between Angion and Elicio, for the purpose of, among other things, considering the approval of the issuance of Angion common stock pursuant to the Merger Agreement, between
Angion and Elicio, pursuant to the Merger.
There will not be a physical meeting location. The special
meeting (which will also serve as Angion’s 2023 annual meeting of stockholders) (Angion special meeting) will be held exclusively online via live audio-only webcast on May 31, 2023, at 9:00 a.m. Pacific Time, and can be accessed by visiting
www.virtualshareholdermeeting.com/ANGN2023SM, where you will be able to attend the Angion special meeting via live audio-only webcast. You will be able to vote your shares and submit questions during the Angion special meeting webcast by
logging in to the website listed above using the 16-digit control number included in your proxy card. Online check-in will begin at 8:45 a.m. Pacific Time, and Angion encourages you to allow ample time for the online check-in procedures.
Please note that you will not be able to attend the Angion special meeting in person. Angion is holding the Angion special meeting to consider the following proposals:
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1.
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Approve the issuance of shares of Angion capital stock pursuant to the Merger, which will represent more than 20% of the
shares of Angion common stock outstanding immediately prior to the Merger and result in a change of control of Angion, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), referred to as the Stock Issuance Proposal;
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2.
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Approve an amendment to the amended and restated certificate of incorporation of Angion to effect a reverse stock split of
Angion common stock at a ratio within the range between 5-for-1 to 30-for-1 (with such ratio to be mutually agreed upon by Angion and Elicio prior to the effectiveness of the Merger or, if the Stock Issuance Proposal is not approved by
Angion stockholders, determined solely by the Angion Board), referred to as the Reverse Stock Split Proposal;
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3.
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Approve an amendment to the Angion amended and restated certificate of incorporation to provide for the exculpation of
officers, referred to as the Exculpation Proposal;
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4.
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Elect the Angion Board nominees, Itzhak Goldberg, M.D., F.A.C.R. and Allen R. Nissenson, M.D., to the Angion Board in the
class of directors to hold office until the 2026 Annual Meeting of Stockholders, referred to as the Director Election Proposal;
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5.
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Ratify the selection of Moss Adams LLP as Angion’s independent registered public accounting firm for the fiscal year ending
December 31, 2023, referred to as the Accounting Firm Proposal; and
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6.
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Approve a postponement or adjournment of the Angion special meeting, if necessary, to solicit additional proxies if there are
not sufficient votes in favor of the Stock Issuance Proposal and/or the Reverse Stock Split Proposal, referred to as the Adjournment Proposal.
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These six proposals are referred to collectively as the Angion
Proposals.
Please read this proxy statement/prospectus/information statement
for further information with respect to the business to be transacted at the Angion special meeting. The Angion board of directors (Angion Board) has fixed April 17, 2023, as the record date for the determination of stockholders entitled to
notice of, and to vote at, the Angion special meeting and any adjournment or postponement thereof. Only holders of record of shares of Angion common stock at the close of business on the record date are entitled to notice of, and to vote at,
the Angion special meeting.
At the close of business on the record date, Angion had 30,114,190 shares of
common stock outstanding and entitled to vote. A complete list of such stockholders entitled to vote at the Angion special meeting will be available for examination at the Angion offices in Newton, Massachusetts during normal business hours for
a period of ten days prior to the Angion special meeting.
Your vote is important. Approval of each of the
Stock Issuance Proposal, the Accounting Firm Proposal and the Adjournment Proposal requires the affirmative vote of a majority of the voting power of the shares of common stock present in person, by remote communication, or represented by proxy
at the Angion special meeting and voting affirmatively or negatively (excluding abstentions and broker non-votes) on the matter. The affirmative vote of the holders of a majority of the Angion common stock outstanding on the record date for the
Angion special meeting is required for the approval of the Reverse Stock Split Proposal and the Exculpation Proposal. With respect to the Director Election Proposal, directors are elected by a plurality of the affirmative votes cast in person
or by proxy at the Angion special meeting, and the nominees for director receiving the highest number of affirmative votes will be elected. No Angion Proposal is conditioned upon any other Angion Proposal. However, each of the Stock Issuance
Proposal and the Reverse Stock Split Proposal is a condition to the consummation of the Merger. Therefore, the Merger cannot be consummated without the approval of the Stock Issuance Proposal and the Reverse Stock Split Proposal.
You are cordially invited to attend the Angion
special meeting. The Angion special meeting can be accessed by visiting www.virtualshareholdermeeting.com/ANGN2023SM, where you will be able to attend the Angion special meeting via live audio-only webcast. You will be able to vote your shares
and submit questions during the Angion special meeting webcast by logging in to the website listed above using the 16-digit control number included in your proxy card. Whether or not you expect to attend the Angion special meeting, to ensure
your representation at the Angion special meeting, Angion urges you to submit a proxy to vote your shares as promptly as possible by (1) visiting the Internet site listed on the enclosed Angion proxy card, (2) calling the toll-free number
listed on the enclosed Angion proxy card or (3) submitting your enclosed Angion proxy card by mail by using the provided self-addressed, stamped envelope. Submitting a proxy will not prevent you from attending by means of remote communication
the Angion special meeting and voting at the Angion special meeting, but it will help to ensure that a quorum is present and avoid added solicitation costs. Any holder of record of Angion common stock as of the record date who attends the
Angion special meeting may vote at the Angion special meeting, thereby revoking any previous proxy. In addition, a proxy may also be revoked in writing before the Angion special meeting in the manner described in this proxy
statement/prospectus/information statement. If your shares are held in the name of a bank, broker or other nominee, please follow the instructions on the voting instruction form furnished by your bank, broker or other nominee.
If you own shares in street name through an account with a bank,
broker or other nominee and you decide to attend the Angion special meeting, you cannot vote at the Angion special meeting unless you present a “legal proxy”, issued in your name from your bank, broker or other nominee. If your shares are held
in a brokerage account or by a bank or other nominee, your ability to vote by telephone or the Internet depends on your broker’s voting process. Please follow the directions provided to you by your broker, bank or nominee.
THE ANGION BOARD HAS UNANIMOUSLY DETERMINED AND
BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO, AND IN THE BEST INTERESTS OF, ANGION AND ITS STOCKHOLDERS. THE ANGION BOARD UNANIMOUSLY RECOMMENDS THAT ANGION’S COMMON STOCKHOLDERS VOTE “FOR” THE STOCK ISSUANCE PROPOSAL, THE
REVERSE STOCK SPLIT PROPOSAL, THE EXCULPATION PROPOSAL, EACH OF THE NOMINEES NAMED IN THE DIRECTOR ELECTION PROPOSAL, THE ACCOUNTING FIRM PROPOSAL AND THE ADJOURNMENT PROPOSAL.
By Order of the Angion Board of Directors,
Jay R. Venkatesan, M.D.
President and Chief Executive Officer
Newton, Massachusetts
April 28, 2023
ABOUT THIS DOCUMENT
This document, which forms part of a registration statement on
Form S-4 filed with the SEC by Angion, constitutes a prospectus of Angion under the Securities Act of 1933, as amended (Securities Act), with respect to the shares of Angion common stock to be issued pursuant to the Merger Agreement, between
Angion and Elicio, pursuant to the Merger. This document also constitutes a notice of a meeting and a proxy statement of Angion under Section 14(a) of the Securities Exchange Act of 1934, as amended (Exchange Act) with respect to the Angion
special meeting at which Angion stockholders will be asked to consider and vote on a proposal to approve the issuance of Angion common stock to the securityholders of Elicio, as well as to consider and vote on certain other proposals.
No one has been authorized to provide you with information that is
different from that contained in this proxy statement/prospectus/information statement. This proxy statement/prospectus/information statement is dated as of the date set forth on the cover hereof. You should not assume that the information
contained in this proxy statement/prospectus/information statement is accurate as of any date other than that date. Neither the mailing of this proxy statement/prospectus/information statement to Elicio stockholders nor the issuance by Angion
of Angion common stock in connection with the proposed Merger will create any implication to the contrary.
This proxy statement/prospectus/information
statement does not constitute an offer to sell, or a solicitation of an offer to buy, any securities, or the solicitation of a proxy, in any jurisdiction in which or from any person to whom it is unlawful to make any such offer or solicitation
in such jurisdiction.
Information contained in this proxy
statement/prospectus/information statement regarding Elicio and its business, operations, management and other matters has been provided by Elicio and information contained in this proxy statement/prospectus/information statement regarding
Angion and its business, operations, management and other matters has been provided by Angion.
If you would like additional copies of this proxy
statement/prospectus/information statement or if you have questions about the proposed Merger or the proposals to be presented at the Angion special meeting, please contact Elicio’s proxy solicitor listed below. You will not be charged for any
of the documents that you request.
You may also request additional copies from Angion’s proxy
solicitor using the following contact information:
Mackenzie Partners, Inc.
Stockholders call toll-free: 1-800-322-2885
Call Collect: 212-929-5500
Email: Angion@mackenziepartners.com
To ensure timely delivery of these
documents, any request should be made no later than May 24, 2023 to receive them before the Angion special meeting.
Angion intends to mail this proxy
statement/prospectus/information statement on or about April 28, 2023, to all stockholders of record entitled to vote at the Angion special meeting.
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Except where specifically noted, the following information and all
other information contained in this proxy statement/prospectus/information statement does not give effect to the proposed reverse stock split (Reverse Stock Split) of common stock of Angion, as described in Proposal No. 2 beginning on page 167 of this proxy statement/prospectus/information statement.
The following section provides answers to frequently asked
questions about the proposed merger transaction and the Angion special meeting. This section, however, provides only summary information. For a more complete response to these questions and for additional information, please refer to the
cross-referenced sections.
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Q:
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What is the Merger?
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A:
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Angion, Merger Sub, and Elicio entered into the Merger Agreement on
January 17, 2023. The Merger Agreement, as it may be further amended from time to time, contains the terms and conditions of the proposed merger transaction among Angion, Merger Sub and Elicio. Under the Merger Agreement, Merger Sub
will merge with and into Elicio, with Elicio surviving as a wholly owned subsidiary of Angion. This transaction is referred to as the Merger.
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The Merger will become effective at the time the Certificate of Merger has been
duly filed with the Secretary of State of the State of Delaware or the Effective Time. At the Effective Time, each share of Elicio preferred stock outstanding immediately prior to the Effective Time and after giving effect to an automatic
conversion of each share of preferred stock of Elicio into shares of Elicio common stock (the Preferred Stock Conversion, excluding shares held as treasury stock by Elicio or held or owned by Angion, Merger Sub or any subsidiary of Angion or
Elicio and excluding shares held by stockholders who have exercised and perfected appraisal rights as more fully described in the section titled “The Merger Agreement—Appraisal Rights and Dissenters’ Rights”
beginning on page 148 of this proxy statement/prospectus/information statement) will be automatically converted solely into the right to receive a number of shares of Angion common stock calculated using an exchange ratio
formula described in the Merger Agreement (Exchange Ratio).
Immediately following the Merger, the pre-Merger equity holders of Elicio are
expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each case, on a
fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. The exchange ratio formula is based upon an Elicio fixed valuation of $95 million and an Angion valuation
of $50.1 million, subject to certain adjustments, including based upon Angion Net Cash at Closing, as more fully described in the section titled “The Merger Agreement—Merger Consideration and Exchange Ratio”
beginning on page 135 of this proxy statement/prospectus/information statement. A $25 million Angion Net Cash threshold is a condition for Elicio to be required to complete the Merger (Net Cash Condition).
If Angion holds less than $26.5 million of net cash at the closing of the Merger,
the equity holders of Angion (pre-Merger) are expected to hold less than 34.5% of the outstanding shares of Angion common stock on a fully diluted basis and if Angion holds more than $31.5 million of net cash at the closing of the Merger, the
equity holders of Angion (pre-Merger) are expected to hold more than 34.5% of the outstanding shares of Angion common stock on a fully diluted basis, as more fully described in the section titled “The Merger
Agreement—Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy statement/prospectus/information statement.
At the Effective Time, Angion’s stockholders will continue to own and hold their
existing shares of Angion common stock, subject to adjustment in connection with the Reverse Stock Split. All outstanding and unexercised options to purchase shares of Angion common stock will remain effective and outstanding. Each option to
purchase shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, whether or not vested, will be converted into an option to purchase shares of Angion common stock, with the number of Angion
shares subject to such option and the exercise price being appropriately adjusted to reflect the exchange ratio. Each outstanding and unexercised warrant to purchase Elicio common stock immediately prior to the Effective Time will be converted
into and become a warrant to purchase shares of Angion common stock. Substantially concurrently with the completion of the Merger, Angion will change its corporate name to “Elicio Therapeutics, Inc.” as required by the Merger Agreement.
1
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Q:
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When will the Exchange Ratio be final?
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A:
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Angion and Elicio will agree to an anticipated closing date at least 15
calendar days prior to the Angion special meeting of stockholders (the Anticipated Closing Date). At least ten calendar days prior to the Angion special meeting of stockholders, Angion will deliver to Elicio a schedule (Net Cash
Schedule) setting forth the estimated calculation of Angion Net Cash as of the Anticipated Closing Date. For further details, see the section titled “The Merger
Agreement—Calculation of Angion Net Cash” beginning on page 142 of this proxy statement/prospectus/information statement.
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Q:
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What will happen to Angion if, for any reason, the Merger does not close?
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A:
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If, for any reason, the Merger does not close, the board of directors
of Angion (Angion Board) may elect to, among other things, continue the business of Angion, attempt to continue to sell or otherwise dispose of the various assets of Angion, dissolve and liquidate its assets or commence bankruptcy
proceedings. Under certain circumstances, Angion may be obligated to pay Elicio a termination fee of either $1 million or $2 million and reimburse certain expenses of Elicio up to $500,000, as more fully described in the section
titled “The Merger Agreement—Termination and Termination Fees” beginning on page 151 of this proxy
statement/prospectus/information statement. If Angion decides to dissolve and liquidate its assets, Angion would be required to pay all of its debts and contractual obligations, and to set aside certain reserves for potential future
claims. There can be no assurances as to the amount or timing of available cash left to distribute to stockholders after paying the debts and other obligations of Angion and setting aside funds for reserves.
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Q:
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Why are the two companies proposing to merge?
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A:
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The Merger will result in a clinical-stage biopharmaceutical company
advancing Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to develop immunotherapies, with a focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors. For a discussion of Angion’s and Elicio’s
reasons for the Merger, please see the section titled “The Merger—Angion Reasons for the Merger” beginning on page 108 of this proxy statement/prospectus/information statement and “The Merger—Elicio Reasons for the Merger”
beginning on page 111 of this proxy statement/prospectus/information statement.
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Q:
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Why am I receiving this proxy statement/prospectus/information statement?
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A:
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You are receiving this proxy statement/prospectus/information statement
because you have been identified as a holder of Angion common stock as of the record date, or a stockholder of Elicio eligible to execute the Elicio written consent. If you are a common stockholder of Angion, you are entitled to vote
at the Angion special meeting, which has been called for the purpose of approving the following proposals:
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1.
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Proposal 1 - the issuance of shares of Angion capital stock pursuant to the Merger,
which will represent more than 20% of the shares of Angion common stock outstanding immediately prior to the Merger and result in a change of control of Angion, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), referred to as the
Stock Issuance Proposal;
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2.
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Proposal 2 - the amendment to the amended and restated certificate of incorporation
of Angion to effect a reverse stock split of Angion common stock at a ratio within the range between 5-for-1 to 30-for-1 (with such ratio to be mutually agreed upon by Angion and Elicio prior to the effectiveness of the Merger or, if
the Stock Issuance Proposal is not approved by Angion stockholders, at a ratio as determined solely by the Angion Board), referred to as the Reverse Stock Split Proposal;
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3.
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Proposal 3 - the amendment to the amended and restated certificate of incorporation
of Angion to provide for the exculpation of officers, referred to as the Exculpation Proposal;
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4.
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Proposal 4 - the election of the Angion Board’s nominees, Itzhak Goldberg, M.D.,
F.A.C.R. and Allen R. Nissenson, M.D., to the Angion Board in the class of directors to hold office until the 2026 Annual Meeting of Stockholders, referred to as the Director Election Proposal;
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5.
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Proposal 5 - the ratification of the selection of Moss Adams LLP as Angion’s
independent registered public accounting firm for the fiscal year ending December 31, 2023, referred to as the Accounting Firm Proposal; and
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2
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6.
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Proposal 6 - the postponement or adjournment of the Angion special meeting, if
necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal and/or the Reverse Stock Split Proposal, referred to as the Adjournment Proposal.
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Angion does not expect that any matter other than these six proposals (the Angion
Proposals) will be brought before the Angion special meeting.
If you are a stockholder of Elicio, you are requested to sign and return the Elicio
written consent to (i) adopt the Merger Agreement and approve the transactions and actions contemplated by the Merger Agreement, including the Merger, (ii) acknowledge that your approval is irrevocable and that you are aware of your rights to
demand appraisal for your shares pursuant to Section 262 of the DGCL and that you have received and read a copy of Section 262 of the DGCL, (iii) consent to conversion of Elicio’s preferred stock to Elicio common stock immediately prior to the
closing of the Merger, if you are a Elicio preferred stockholder, and (iv) acknowledge that by your approval of the Merger you are not entitled to appraisal rights or dissenters’ rights with respect to your shares in connection with the Merger
and thereby waive any rights to receive payment of the fair value of your capital stock under the DGCL (items (i) through (iv), collectively, the Elicio Stockholder Matters).
This document serves as: (x) a proxy statement of Angion used to solicit proxies
for the Angion special meeting, (y) a prospectus of Angion used to offer shares of Angion common stock (i) in exchange for shares of Elicio capital stock in the Merger and (ii) upon exercise of the warrants to purchase shares of Elicio common
stock assumed in the Merger in exchange for the warrants to purchase shares of Angion common stock and (z) an information statement of Elicio used to solicit the written consent of its stockholders for the adoption of the Merger Agreement and
the approval of the Merger and related transactions after the declaration of the effectiveness of this Registration Statement, of which this proxy statement/prospectus/information statement is a part. Information about the Angion special
meeting, the Merger, the Merger Agreement and the other business to be considered by Angion stockholders at the Angion special meeting, and by Elicio stockholders to consider in determining whether to sign and return the Elicio written consent,
is contained in this proxy statement/prospectus/information statement. Angion stockholders and Elicio stockholders should read this information carefully and in its entirety. The enclosed voting materials allow Angion stockholders to vote their
shares by proxy without attending the Angion special meeting.
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Q:
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What is required to consummate the Merger?
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A:
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To consummate the Merger, Angion’s common stockholders must approve the
Required Angion Closing Stockholder Matters (Proposal Nos. 1 and 2 above) and Elicio’s stockholders must approve the Elicio Stockholder Matters.
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Certain of Elicio’s stockholders and certain of Angion’s stockholders are parties
to Support Agreements with Angion and Elicio whereby such stockholders have agreed, subject to the terms of the Support Agreements, to vote their shares (or execute a written consent) in favor of the Required Angion Closing Stockholder Matters
or the Elicio Stockholder Matters, as applicable.
In addition to the requirement of obtaining stockholder approval of the Required
Angion Closing Stockholder Matters and the Elicio Stockholder Matters, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived. For a complete description of the closing conditions under the Merger
Agreement, refer to the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 139 of this proxy statement/prospectus/information
statement.
In the event of a waiver of a condition, the Angion Board will evaluate the
materiality of any such waiver to determine whether amendment of this proxy statement/prospectus/information statement and resolicitation of stockholder approval is necessary. For more information, refer to the section titled “Risk Factors Related to the Merger—Angion or Elicio may waive one or more of the conditions to the Merger without recirculation of this proxy statement/prospectus/information statement or resoliciting stockholder
approval” beginning on page 25 of this proxy statement/prospectus/information statement.
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Q:
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What will Elicio’s stockholders, option holders and warrant holders receive in the Merger?
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A:
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Each share of Elicio capital stock outstanding will be converted into
the right to receive a number of shares of Angion common stock calculated using the Exchange Ratio. Angion will assume outstanding and unexercised options to purchase shares of Elicio capital stock, and in connection with the Merger
such options will be converted into options
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3
to purchase shares of Angion common stock, with the number of Angion shares
subject to such option and the exercise price being appropriately adjusted to reflect the Exchange Ratio. Each outstanding and unexercised warrant to purchase Elicio common stock immediately prior to the Effective Time will be converted into
and become a warrant to purchase shares of Angion common stock, adjusted to reflect the Exchange Ratio and treated in accordance with the terms thereof. For a more complete description of what Elicio’s stockholders and option holders will
receive in the Merger, please see the section titled “The Merger Agreement—Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy
statement/prospectus/information statement.
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Q:
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What will Angion’s stockholders and option holders receive in the Merger?
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A:
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At the Effective Time, Angion’s stockholders will continue to own and
hold their existing shares or options to purchase shares of Angion common stock.
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Q:
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Who will be the directors of Angion following the Merger?
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A:
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At the Effective Time, the combined company is expected to initially
have a nine-member board of directors, comprising (a) Robert Connelly, Julian Adams, Ph.D., Carol Ashe, Yekaterina (Katie) Chudnovsky, Daphne Karydas, and Assaf Segal, each as an Elicio designee and (b) Jay Venkatesan, M.D., MBA,
Karen J. Wilson, and Allen R. Nissenson, M.D., each as an Angion designee, until their respective successors are duly elected or appointed and qualified or their earlier death, resignation or removal. The aforementioned board of
directors will have an audit committee, a compensation committee and a nominating and corporate governance committee, in accordance with the rules of Nasdaq. All of Angion’s current directors other than Dr. Venkatesan, Karen J.
Wilson, and Allen R. Nissenson, M.D. are expected to resign from their positions as directors of Angion, effective upon the Effective Time.
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Q:
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Who will be the executive officers of Angion following the Merger?
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A:
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Immediately following the Merger, the executive management team of the
combined company is expected to comprise the following individuals with such additional officers as may be added by Elicio or the combined company:
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Name
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Position with the Combined Company
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Current Position at Elicio
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Robert Connelly
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Chief Executive Officer, President and Director
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Chief Executive Officer
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Daniel Geffken
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Interim Chief Financial Officer
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Interim Chief Financial Officer
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Christopher Haqq, M.D., Ph.D.
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Executive Vice President, Head of Research and Development and Chief Medical
Officer
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Executive Vice President, Head of Research and Development and Chief Medical
Officer
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Annette Matthies, Ph.D.
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Chief Business Officer
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Chief Business Officer
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Peter DeMuth, Ph.D.
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Chief Scientific Officer
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Chief Scientific Officer
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Q:
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As a stockholder of Angion, how does the Angion Board recommend that I vote?
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A:
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After careful consideration, the Angion Board unanimously recommends
that the holders of Angion common stock vote:
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•
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“FOR” Proposal 1 - the Stock Issuance Proposal;
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•
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“FOR” Proposal 2 - the Reverse Stock Split Proposal;
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•
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“FOR” Proposal 3 - the Exculpation Proposal.
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•
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“FOR” Proposal 4 - the election of the Angion Board’s nominees in the Director Election
Proposal;
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•
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“FOR” Proposal 5 - the Accounting Firm Proposal; and
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4
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•
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“FOR” Proposal 6 - the Adjournment Proposal.
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For more information on each proposal and the Angion Board’s recommendations,
please see the section titled “Matters Being Submitted to a Vote of Angion’s Stockholders” beginning on page 166 of this proxy statement/prospectus/information statement.
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Q:
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How many votes are needed to approve each proposal?
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A:
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Approval of each of the Stock Issuance Proposal, the Accounting Firm
Proposal, and the Adjournment Proposal requires the affirmative vote of the holders of a majority of the voting power of the shares outstanding on the record date for the Angion special meeting present in person, by remote
communication, or represented by proxy at the meeting and voting affirmatively or negatively (excluding abstentions and broker non-votes) on this matter.
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Approval of each of the Reverse Stock Split Proposal and the Exculpation Proposal
requires the affirmative vote of the holders of a majority of the Angion common stock outstanding on the record date for the Angion special meeting. Abstentions and broker non-votes, if any, will have the same effect as “Against” votes.
With respect to the Director Election Proposal, directors are elected by a
plurality of the affirmative votes cast in person or by proxy at the Angion special meeting, and the two nominees for director receiving the highest number of affirmative votes will be elected. Only votes “For” will affect the outcome of the
vote; “Withhold” votes and broker non-votes will have no effect on the outcome of the vote.
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Q:
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As a stockholder of Elicio, how does the board of directors of Elicio recommend that I vote?
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A:
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After careful consideration, the Elicio Board unanimously recommends
that the Elicio stockholders execute the written consent indicating their vote in favor of the Elicio Stockholder Matters.
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Q:
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What risks should I consider in deciding whether to vote in favor of the Angion Proposals or to execute and
return the written consent, as applicable?
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A:
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You should carefully review the section of the proxy
statement/prospectus/information statement titled “Risk Factors,” which sets forth certain risks and uncertainties related to the
Merger, risks and uncertainties to which the combined company’s business will be subject, and risks and uncertainties to which each of Angion and Elicio, as an independent company, is subject.
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Q:
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When do you expect the Merger to be consummated?
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A:
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We anticipate that the Merger will be consummated during the second
quarter of 2023, soon after the Angion special meeting to be held on May 31, 2023 but we cannot predict the exact timing. For more information, please see the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 139 of
this proxy statement/prospectus/information statement.
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Q:
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What are the material U.S. federal income tax consequences of the Merger to U.S. holders of Elicio shares?
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A:
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Angion and Elicio intend the Merger to qualify as a reorganization
within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (Code), as described in the section titled “The Merger—Material U.S. Federal Income
Tax Consequences of the Merger” beginning on page 128 of this proxy statement/prospectus/information statement. If the Merger so qualifies, Elicio stockholders who are
U.S. holders (as defined in the section titled “The Merger—Material U.S. Federal Income Tax Consequences of the Merger” beginning
on page 128 of this proxy statement/prospectus/information statement) generally will not recognize gain or loss for U.S. federal income tax purposes on the receipt of shares of Angion common stock issued in
connection with the Merger. Each Elicio stockholder who is a U.S. holder who receives cash in lieu of a fractional share of Angion common stock generally will recognize capital gain or loss in an amount equal to the difference between
the amount of cash received in lieu of such fractional share and such Elicio stockholder’s tax basis allocable to such fractional share.
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If the Merger does not qualify as a reorganization within the meaning of Section
368(a) of the Code, then each Elicio stockholder who is a U.S. holder will generally recognize capital gain or loss for U.S. federal income tax purposes on the receipt of shares of Angion common stock issued in connection with the Merger, as
well as on
5
any cash such Elicio stockholder receives in lieu of a fractional share of
Angion common stock. The tax consequences to each Elicio stockholder will depend on that stockholder’s particular circumstances. Each Elicio stockholder should consult with his, her or its tax advisor for a full understanding of the tax
consequences of the Merger to that Elicio stockholder.
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Q:
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What are the material U.S. federal income tax consequences of the Reverse Stock Split to U.S. holders of
Angion shares?
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A:
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Angion intends to treat the Reverse Stock Split as a “recapitalization”
for U.S. federal income tax purposes. If it so qualifies, an Angion stockholder who is a U.S. holder (as defined in the section titled “Matters Being Submitted to a Vote of
Angion’s Stockholders—Proposal No. 2: Approval of an Amendment to the Amended and Restated Certificate of Incorporation of Angion
Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” beginning on page 167 of this proxy
statement/prospectus/information statement) should not recognize gain or loss upon the Reverse Stock Split (other than in respect of cash received in lieu of fractional shares). A U.S. holder’s aggregate tax basis in the shares of
Angion common stock received pursuant to the Reverse Stock Split should equal the aggregate tax basis of the shares of Angion common stock surrendered (excluding any portion of such basis that is allocated to any fractional share of
Angion common stock), and such U.S. holder’s holding period in the shares of Angion common stock received should include the holding period in the shares of Angion common stock surrendered. Treasury Regulations provide detailed rules
for allocating the tax basis and holding period of the shares of Angion common stock surrendered to the shares of Angion common stock received in a “recapitalization”. U.S. holders of shares of Angion common stock acquired on
different dates and at different prices should consult their tax advisors regarding the allocation of the tax basis and holding period of such shares.
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Please review the information in the section titled “Matters Being Submitted to a Vote of Angion’s Stockholders—Proposal No. 2: Approval of an Amendment to the Amended and Restated Certificate of Incorporation of Angion Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” beginning on page 171 of this proxy statement/prospectus/information statement for
a more complete description of the material U.S. federal income tax consequences of the Reverse Stock Split to Angion U.S. holders.
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Q:
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What do I need to do now?
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A:
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Angion and Elicio urge you to read this proxy
statement/prospectus/information statement carefully, including its annexes and information incorporated herein, and to consider how the Merger affects you.
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If you are a common stockholder of Angion, please vote your shares as soon as
possible so that your shares will be represented at the Angion special meeting. Please follow the instructions set forth on the enclosed Angion proxy card or on the voting instruction form provided by the record holder of your shares if your
shares are held in the name of your bank, broker or other nominee.
If you are a stockholder of Elicio, you may execute and return your written consent
to Elicio in accordance with the instructions provided by Elicio once this Registration Statement is declared effective by the SEC.
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Q:
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When and where is the Angion special meeting? What must I do to attend the Angion special meeting?
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A:
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The Angion special meeting will be held exclusively online via live
audio-only webcast on May 31, 2023 at 9:00 a.m. Pacific Time. Online check-in will begin at 8:45 a.m. Pacific Time, and Angion encourages you to allow ample time for the online check-in procedures.
Please note that you will not be able to attend the Angion special meeting in person.
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You or your authorized proxy may attend the Angion special meeting if you were a
registered or beneficial stockholder of Angion common stock as of the record date.
You will be able to vote your shares and submit questions during the Angion special
meeting webcast by logging in to the website listed above using the 16-digit control number included in your proxy card. If you wish to submit a question during the Angion special meeting, log into the Angion special meeting platform at
www.virtualshareholdermeeting.com/ANGN2023SM, type your question into the “Ask a Question” field, and click “Submit.” Angion will respond to as many properly submitted questions during the relevant portion of the Angion special meeting agenda
as time allows.
6
If Angion experiences technical difficulties during the Angion special meeting
(e.g., a temporary or prolonged power outage), Angion will determine whether the Angion special meeting can be promptly reconvened (if the technical difficulty is temporary) or whether the Angion special meeting will need to be reconvened on a
later day (if the technical difficulty is more prolonged). In any situation, Angion will promptly notify stockholders of the decision via www.virtualshareholdermeeting.com/ANGN2023SM. Angion will have technicians ready to assist you with any
technical difficulties you may have accessing the Angion special meeting website. If you encounter any difficulties accessing the Angion special meeting website during the check-in or meeting time, please call the technical support number that
will be posted on the Angion special meeting website log-in page at www.virtualshareholdermeeting.com/ANGN2023SM.
If you own shares in street name through an account with a bank, broker or other
nominee, please send proof of your Angion share ownership as of the record date (for example, a brokerage firm account statement or a “legal proxy” from your intermediary) along with your registration request. If you are not sure what proof to
send, check with your intermediary.
If your shares are registered in your name with Angion’s stock registrar and
transfer agent, Continental Stock Transfer & Trust Company, no proof of ownership is necessary because Angion can verify your ownership.
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Q:
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How are votes counted?
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A:
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Votes will be counted by the inspector of elections appointed for the
meeting, who will separately count votes “FOR” and “AGAINST,” abstentions and, if applicable, broker non-votes.
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Angion does not expect that any matters other than the Angion Proposals will be
brought before the Angion special meeting.
|
Q:
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What are “broker non-votes”?
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|
A:
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Brokers who hold shares in street name for customers have the authority
to vote on “routine” proposals when they have not received instructions from beneficial owners. However, brokers are precluded from exercising their voting discretion with respect to approval of non-routine matters, and, as a result,
absent specific instructions from the beneficial owner of such shares, brokers are not empowered to vote those shares, referred to generally as “broker non-votes.” Broker non-votes, if any, will be treated as shares that are present
at the Angion special meeting for purposes of determining whether a quorum exists but will not have any effect for the purpose of voting on Proposal No. 1 (Stock Issuance Proposal), Proposal No. 4 (Director Election Proposal),
Proposal No. 5 (Accounting Firm Proposal) and Proposal No. 6 (Adjournment Proposal). Broker non-votes, if any, will have the same effect as “AGAINST” votes for Proposal No. 2 (Reverse Stock
Split Proposal) and Proposal No. 3 (Exculpation Proposal).
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Q:
|
What will happen if I return my proxy form without indicating how to vote?
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|
A:
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If you submit your proxy form without indicating how to vote your
shares on any particular proposal, the common stock represented by your proxy will be voted as recommended by the Angion Board with respect to that proposal.
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Q:
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May I change my vote after I have submitted a proxy or voting instruction form?
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A:
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Angion’s common stockholders of record, other than those Angion
stockholders who are parties to voting agreements, may change their vote at any time before their proxy is voted at the Angion special meeting in one of following ways:
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•
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By sending a written notice to the Secretary of Angion stating that it would like to revoke its proxy.
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•
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By duly executing a subsequently dated proxy relating to the same shares of common stock and return it in the postage-paid
envelope provided or similar means, which subsequent proxy is received before the prior proxy is exercised at the Angion special meeting;
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•
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Duly submitting a subsequently dated proxy relating to the same shares of common stock by telephone or via the Internet
(i.e., your most recent duly submitted voting instructions will be followed) before 11:59 p.m. Eastern Time on May 30, 2023; and
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•
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By attending the Angion special meeting and voting such shares during the Angion special meeting.
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7
If a stockholder who owns Angion shares in “street name” has instructed a broker
to vote its shares of Angion common stock, the stockholder must follow directions received from its broker to change those instructions.
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Q:
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Who is paying for this proxy solicitation?
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A:
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Angion will pay for the cost of printing and filing of this proxy
statement/prospectus/information statement and the proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of Angion common stock for the forwarding of
solicitation materials to the beneficial owners of Angion common stock. Angion will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding
of solicitation materials. In addition, Angion has engaged Mackenzie Partners, Inc., a proxy solicitation firm, to solicit proxies from Angion’s stockholders for a fee of up to $9,500 plus certain additional costs associated with
solicitation campaigns. Fees paid to the SEC in connection with filing the statement/prospectus/information statement, and any amendments and supplements thereto, with the SEC will be paid by Angion.
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Q:
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What is the quorum requirement?
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A:
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A quorum of stockholders is necessary to hold a valid meeting. The
presence at the Angion special meeting, virtually or represented by proxy, of the holders of a majority of the voting power of the stock issued, outstanding and entitled to vote thereat, as of the record date, will constitute a quorum
for the transaction of business at the Angion special meeting.
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Your shares will be counted towards the quorum if you submit a valid proxy (or one
is submitted on your behalf by your broker, bank or other nominee) or if you attend the Angion special meeting and vote your shares during the Angion special meeting. Abstentions and broker non-votes, if applicable, will also be counted towards
the quorum requirement. If there is no quorum, the person presiding over the Angion special meeting, or the holders of a majority of shares present at the Angion special meeting or represented by proxy, may adjourn the meeting to another date.
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Q:
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Should Angion’s and Elicio’s stockholders send in their stock certificates now, to the extent they have any?
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A:
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No. After the Merger is consummated, Elicio’s stockholders will receive
written instructions from the exchange agent for exchanging their certificates representing shares of Elicio capital stock for certificates representing shares of Angion common stock. Each Elicio stockholder who otherwise would be
entitled to receive a fractional share of Angion common stock will be entitled to receive an amount in cash, without interest, determined by multiplying such fraction by the volume-weighted average closing trading price of a share of
Angion common stock on Nasdaq for the five consecutive trading days ending five trading days immediately prior to the date upon which the Merger becomes effective.
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In addition, Angion’s stockholders will receive written instructions, as
applicable, from Angion’s transfer agent, Continental Stock Transfer & Trust Company, for exchanging their certificates representing shares Angion common stock for new certificates giving effect to the Reverse Stock Split, if effected.
Angion’s stockholders will also receive a cash payment in lieu of any fractional shares, determined by multiplying such fraction by the fair market value per share of Angion common stock immediately prior to the effective time of the Reverse
Stock Split as determined by the Angion Board.
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Q:
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Who can help answer my questions?
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A:
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If you are a stockholder of Angion and would like additional copies,
without charge, of this proxy statement/prospectus/information statement or if you have questions about the Merger, including the procedures for voting your shares, you should contact Mackenzie Partners, Inc., Angion’s proxy
solicitor, by telephone, toll-free, at 1-800-322-2885 (toll-free), 212-929-5500 (call collect) or by email at Angion@mackenziepartners.com.
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If you are a stockholder of Elicio, and would like additional copies, without
charge, of this proxy statement/prospectus/information statement or if you have questions about the Merger, including the procedures for voting your shares, you should contact:
451 D Street, 5th Floor, Suite 501
Boston, Massachusetts 02210
(857) 209-0050
Attention: Chief Executive Officer
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This summary highlights selected information
from this proxy statement/prospectus/information statement and may not contain all of the information that is important to you. To better understand the Merger, the proposals being considered at the Angion special meeting and Elicio’s
stockholder actions that are the subject of the written consent, you should read this entire proxy statement/prospectus/information statement carefully, including the Merger Agreement attached as Annex A and the other annexes to which you are
referred herein. For more information, please see the section titled “Where You Can Find More Information” beginning on page 307 of this proxy statement/prospectus/information statement.
Angion Biomedica Corp.
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
Angion is a biopharmaceutical company that has focused on the
discovery, development and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases. Angion was incorporated in Delaware in 1998.
Angion’s product candidates and programs include ANG-3070, a
highly selective oral tyrosine kinase receptor inhibitor (TKI) in development as a treatment for fibrotic diseases, a Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) preclinical program targeted towards the treatment of
fibrotic diseases, a Cytochrome P450 Family 11 Subfamily B Member 2 (CYP11B2) preclinical program targeted towards diseases related to aldosterone synthase dysregulation, and a CYP26 (retinoic acid metabolism) inhibitor program targeted
towards a number of indications, including cancer.
Angion has suspended clinical development activities and does
not have any products approved for sale. In July 2022, Angion took steps to conserve cash resources and cut operating expenses, reducing its workforce significantly while evaluating strategic alternatives. Strategic alternatives were
evaluated with a goal to enhance stockholder value, including the possibility of a merger or sale of Angion. On January 17, 2023, Angion announced the entry into the Merger Agreement.
Elicio Therapeutics, Inc.
451 D Street, 5th Floor, Suite 501,
Boston, MA 02210
(857) 209-0050
Elicio is a clinical-stage biotechnology company pioneering the
development of therapeutic cancer vaccines for patients with limited treatment options and poor outcomes. Through its AMP platform technology, Elicio’s goal is to re-engineer the body’s immune response to defeat diseases using potent lymph
node targeted vaccines and immunotherapies.
Elicio’s proprietary AMP technology precisely traffics
immuno-modulatory molecules to the lymph nodes, the “schoolhouse” of the immune system, enhancing the magnitude, potency, functionality, and durability of the immune response. The lymph nodes are a primary site in the body where most immune
cells are located. The lymph nodes are where the immune system naturally collects information about health and disease in order to orchestrate the mechanisms of immunity which protect us from pathogens and tumors. By efficiently targeting
these sites within the body we are taking advantage of the power and the unique biology of the lymph nodes to improve responses across a broad range of diseases. Elicio’s is utilizing its lymph-node targeting technology to build a pipeline of
therapeutic cancer vaccines, which will be the focus of Elicio. Other applications of the AMP technology, such as infectious disease (ID) vaccines and immune cell therapies, will be developed through partnerships.
Elicio’s core business is the development of therapeutic cancer
vaccines. ELI-002, its lead clinical program, is designed to stimulate an immune response against the Kirsten rat sarcoma virus (KRAS) mutations driving 25% of solid tumors. ELI-002 is currently being studied in AMPLIFY-201 in patients with
mutant (m)KRAS-driven Pancreatic ductal adenocarcinoma (PDAC) and Colorectal cancer (CRC).
9
Arkham Merger Sub, Inc.
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
Merger Sub is a wholly-owned subsidiary of Angion and was formed
solely for the purposes of carrying out the Merger.
The Merger (see page 100)
On January 17, 2023, Angion, Merger Sub, and Elicio entered into
the Merger Agreement, pursuant to which Merger Sub will merge with and into Elicio, with Elicio surviving as a wholly owned subsidiary of Angion. Angion common stock will be issued to the stockholders of Elicio at the Effective Time and
Angion will assume each Elicio option and warrant which will become options and warrants to purchase Angion common stock at the Effective Time. In connection with the Closing, Angion will change its name to “Elicio Therapeutics, Inc.”
References to the combined company in this proxy statement/prospectus/information statement are references to Angion and its consolidated subsidiaries following the Merger and references to the surviving company are to Elicio following the
Merger.
Angion and Elicio expect the Merger to be consummated during the
second quarter of 2023, subject to satisfaction or waiver of certain conditions to the Closing, including, among other things, approval by Angion’s stockholders of the Stock Issuance Proposal and the Reverse Stock Split Proposal
(collectively, the Required Angion Closing Stockholder Matters).
Immediately following the Merger, the pre-Merger equity holders
of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each
case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. The Net Cash Condition means that Angion Net Cash must be no less than $25 million in order
for Elicio to be required to complete the Merger. For a more complete description of the Merger and the potential adjustments in the Exchange Ratio, please see the section titled “The Merger Agreement—Merger
Consideration and Exchange Ratio.”
Reasons for the Merger (see page 108)
The Angion Board considered various reasons for the Merger, as
described later in this proxy statement under the section titled “The Merger—Angion Reasons for the Merger.”
Opinion of Angion’s Financial
Advisor (see page 112)
Angion engaged Oppenheimer to serve as a financial advisor to
Angion in connection with reviewing and considering other potential strategic transaction opportunities, including the proposed Merger. At the January 13, 2023 meeting of the Angion Board, representatives of Oppenheimer rendered Oppenheimer’s
oral opinion, which was subsequently confirmed by delivery of a written opinion to the Angion Board dated January 13, 2023, as to the fairness, as of such date, from a financial point of view, to Angion of the Exchange Ratio in the Merger
pursuant to the Merger Agreement, based upon and subject to the assumptions made, procedures followed, matters considered and qualifications and limitations on the scope of the review undertaken by Oppenheimer in connection with the
preparation of its opinion.
The full text of the written opinion of Oppenheimer, dated
January 13, 2023, which sets forth, among other things, the various assumptions made, procedures followed, matters considered and qualifications and limitations on the scope of the review undertaken, is attached as Annex B to this document. Oppenheimer provided its opinion for the information and assistance of the Angion Board (in its capacity as such) in connection with, and for purposes of, its consideration of the Merger, and its
opinion only addresses whether the Exchange Ratio in the Merger pursuant to the Merger Agreement was fair, from a financial point of view, to Angion. The opinion of Oppenheimer did not address any other term or aspect of the Merger Agreement
or the Merger. The Oppenheimer opinion does not constitute a recommendation to the Angion Board or any holder of Angion’s common stock as to how the Angion Board, such stockholder or any other person should vote or otherwise act with respect
to the Merger or any other matter, or whether to enter into a support agreement with either Angion or Elicio.
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Merger Consideration and Exchange
Ratio (see page 135)
Pursuant to the Merger Agreement, at the Effective Time, each
share of Elicio capital stock outstanding immediately prior to the Effective Time and after giving effect to the Preferred Stock Conversion will be automatically converted solely into the right to receive a number of shares of Angion common
stock equal to the Exchange Ratio.
No fractional shares of Angion common stock will be issued in
connection with the Merger, and no certificates or scrip for any such fractional shares will be issued. Any holder of Elicio capital stock who would otherwise be entitled to receive a fraction of a share of Angion common stock (after
aggregating all fractional shares of Angion common stock issuable to such holder) will, in lieu of such fraction of a share and upon such holder’s surrender of a letter of transmittal in accordance with the Merger Agreement and any
accompanying documentation required therein, be paid in cash the dollar amount (rounded up to the nearest whole cent), without interest, determined by multiplying such fraction by the volume weighted average closing trading price of a share
of Angion common stock (Angion Closing Price) on Nasdaq for the five consecutive trading days ending three trading days immediately prior to the date of the public announcement of the Merger Agreement, which is equal to $0.9110.
The Exchange Ratio formula is derived based upon an Elicio fixed
valuation of $95 million and an Angion valuation of $50.1 million, subject to certain adjustments, including based upon Angion Net Cash at Closing. The calculation of Angion Net Cash at Closing includes, among other things, a credit for cash
proceeds Angion receives from the sale, transfer, license, assignment or other divestiture of its intellectual property and other assets and technology in existence on the date of the Merger Agreement prior to or substantially concurrently
with the Closing and a reduction for certain liabilities. The Net Cash Condition means that Angion Net Cash must be no less than $25 million in order for Elicio to be required to complete the Merger.
Immediately following the Merger, the pre-Merger equity holders
of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each
case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million.
For a more complete description of the Merger, the potential
adjustments in the Exchange Ratio and the calculation of Angion Net Cash, please see the section titled “The Merger Agreement —Merger Consideration and Exchange Ratio.”
Treatment of Elicio Stock Options
(see page 138)
Under the terms of the Merger Agreement, each option to purchase
shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, whether or not vested, will be converted into an option to purchase shares of Angion common stock. Angion will assume the Elicio’s 2022
Equity Incentive Plan and Elicio’s 2012 Equity Incentive Plan (together, the Elicio Plans), and all rights with respect to each outstanding option to purchase Elicio common stock in accordance with its terms and the terms of the stock option
agreement by which such option is evidenced.
Accordingly, from and after the Effective Time: (i) each
outstanding Elicio stock option assumed by Angion may be exercised solely for shares of Angion common stock; (ii) the number of shares of Angion common stock subject to each outstanding Elicio stock option assumed by Angion will be determined
by multiplying (A) the number of shares of Elicio common stock that were subject to such Elicio stock option, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio, and rounding the resulting number down to the
nearest whole number of shares of Angion common stock; (iii) the per share exercise price for the Angion common stock issuable upon exercise of each Elicio stock option assumed by Angion will be determined by dividing (A) the per share
exercise price of Angion common stock subject to such Elicio stock option, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio and rounding the resulting exercise price up to the nearest whole cent; and (iv) any
restriction on the exercise of any Elicio stock option assumed by Angion will continue in full force and effect and the term, exercisability, vesting schedule, accelerated vesting provisions, and any other provisions of such Elicio stock
option will otherwise remain unchanged; provided, however, that the Angion Board or a committee thereof will succeed to the authority and responsibility of the board of directors of Elicio or any committee thereof with respect to each Elicio
stock option assumed by Angion.
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Treatment of Elicio Warrants (see
page 138)
Under the terms of the Merger Agreement, each warrant to
purchase shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, will be converted into and become a warrant to purchase shares of Angion common stock and Angion will assume each Elicio
warrant in accordance with its terms.
Accordingly, from and after the Effective Time: (i) each
outstanding Elicio warrant assumed by Angion may be exercised solely for shares of Angion common stock; (ii) the number of shares of Angion common stock subject to each outstanding Elicio warrant assumed by Angion will be determined by
multiplying (A) the number of shares of Elicio common stock, or the number of shares of Elicio preferred stock issuable upon exercise of the Elicio warrant, as applicable, that were subject to such Elicio warrant, as in effect immediately
prior to the Effective Time, by (B) the Exchange Ratio, and rounding the resulting number down to the nearest whole number of shares of Angion common stock; (iii) the per share exercise price for the Angion common stock issuable upon exercise
of each Elicio warrant assumed by Angion will be determined by dividing (A) the per share exercise price of Angion common stock subject to such Elicio warrant as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio and
rounding the resulting exercise price up to the nearest whole cent; and (iv) any restriction on the exercise of any Elicio warrant assumed by Angion will continue in full force and effect and the term and other provisions of such Elicio
warrant will otherwise remain unchanged.
Conditions to the Completion of
the Merger (see page 139)
The obligations to consummate the Merger and the other
transactions and actions contemplated by the Merger Agreement (collectively, the Contemplated Transactions) are subject to the satisfaction or waiver, on or prior to the Effective Time, of the conditions set forth in the section titled “The Merger Agreement—Conditions to the Completion of the Merger” below.
Non-Solicitation (see page 144)
Capitalized terms in this section are as defined in the section
titled “Merger Agreement—Non-Solicitation.”.
Angion and Elicio and their respective subsidiaries are
prohibited by the terms of the Merger Agreement, other than, in the case of Angion, with respect to any Asset Disposition (as defined below), from, directly or indirectly, (i) soliciting, initiating or knowingly encouraging, inducing or
facilitating the communication, making, submission or announcement of any Acquisition Proposal (as defined below) or Acquisition Inquiry (as defined below) or taking any action that could reasonably be expected to lead to an Acquisition
Proposal or Acquisition Inquiry; (ii) furnishing any non-public information regarding such party to any person in connection with or in response to an Acquisition Proposal or Acquisition Inquiry; (iii) engaging in discussions or negotiations
with any person with respect to any Acquisition Proposal or Acquisition Inquiry; (iv) approving, endorsing or recommending any Acquisition Proposal; (v) executing or entering into any letter of intent or any contract contemplating or
otherwise relating to any Acquisition Transaction (as defined below) (other than, in the case of Angion, a confidentiality agreement permitted as described below); or (vi) publicly proposing to do any of the foregoing.
Subject to certain restrictions and prior to obtaining the
approval of the Required Angion Closing Stockholder Matters by the Required Angion Stockholder Vote (as defined below), Angion and its subsidiaries may furnish non-public information regarding Angion or any of its subsidiaries to, and enter
into discussions or negotiations with, any person in response to a bona fide Acquisition Proposal by such person, which the Angion Board determines in good faith, after consultation with its outside
financial advisor and outside legal counsel, constitutes, or is reasonably likely to result in, a Superior Offer (as defined below) (and is not withdrawn) if: (A) none of Angion, any of its subsidiaries or any of their respective
representatives have breached the non-solicitation restrictions in the Merger Agreement in any material respect, (B) the Angion Board concludes in good faith, based on the advice of outside legal counsel, that the failure to take such action
is reasonably likely to be inconsistent with the fiduciary duties of the Angion Board under applicable law; (C) substantially contemporaneously with furnishing any such nonpublic information to such person, Angion gives Elicio notice of
Angion’s intention to furnish nonpublic information to or enter into discussions with, such person and furnishes such nonpublic information to Elicio (to the extent such information has not been previously furnished to Elicio), and (D) Angion
receives from such person an executed confidentiality agreement containing provisions (including nondisclosure provisions, use restrictions, non-solicitation provisions, no hire and “standstill” provisions), in the aggregate, at least as
favorable to it as those contained in the confidentiality agreement entered into between Angion and Elicio in connection with the Merger.
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For a more complete description of the non-solicitation
provisions, please see the section titled “The Merger Agreement—Non-Solicitation.”
Termination and Termination Fees
(see page 151)
Capitalized Terms are as defined in the section titled “Merger Agreement—Termination and Termination Fees.”
The Merger Agreement contains certain customary termination
rights, including the right of Angion to terminate the Merger Agreement if the Elicio Stockholder Written Consent (as defined below) has not been obtained within three business days of the date of the Registration Statement becoming
effective, the right of Angion or Elicio to terminate the Merger Agreement if Angion’s stockholders fail to adopt and approve the Required Angion Closing Stockholder Matters, the right of Elicio to terminate the Merger Agreement if the Angion
Board changes or withdraws its recommendation in favor of the Required Angion Closing Stockholder Matters or approves or enters into an agreement relating to an Acquisition Proposal and the right of Angion to terminate the Merger Agreement
under certain circumstances to enter into an agreement relating to a Superior Offer.
Upon termination of the Merger Agreement by Elicio or Angion in
certain circumstances, a termination fee of $1 million may be payable by Elicio to Angion or by Angion to Elicio. Additionally, in the event of a termination under certain circumstances, including a termination of the Merger Agreement by
Angion to enter into an agreement relating to a Superior Offer, a termination fee of $2 million or $1 million may be payable by Angion to Elicio. Angion has agreed to reimburse Elicio for up to $500,000 in expenses if the Merger Agreement is
terminated due to the failure to obtain the approval of the Required Angion Closing Stockholder Matters from Angion’s stockholders, if the Net Cash Condition (as defined below) is not satisfied as of the End Date (as defined below) or in the
event of the failure of Elicio to consummate the Contemplated Transactions (as defined below) solely as a result of an Angion Material Adverse Effect (as defined below). Elicio has agreed to reimburse Angion for up to $500,000 in expenses if
the Merger Agreement is terminated due to a breach or inaccuracy of any representation, warranty, covenant or agreement by Elicio or in the event of the failure of Elicio to consummate the Contemplated Transactions solely as a result of an
Elicio Material Adverse Effect.
For a more complete description of the termination provisions
and termination fees, please see the section titled “The Merger Agreement—Termination and Termination Fees.”
Support Agreements (see page 156)
Concurrently with the execution of the Merger Agreement,
executive officers, directors and stockholders of Angion entered into support agreements (Angion Support Agreements) in favor of Elicio relating to the Merger. The Angion Support Agreements provide, among other things, that such officers,
directors and stockholders will vote all of their shares of Angion common stock: (i) in favor of adopting the Merger Agreement and approving the Merger, the Required Angion Closing Stockholder Matters, and the other Contemplated Transactions,
(ii) against any proposal made in opposition to, or in competition with, the Merger Agreement or the Merger and (iii) against any acquisition proposal involving a third party.
Concurrently with the execution of the Merger Agreement,
executive officers, directors and stockholders of Elicio entered into support agreements (Elicio Support Agreements, together with the Angion Support Agreements, the Support Agreements) in favor of Angion relating to the Merger. The Elicio
Support Agreements provide, among other things, that such executive officers, directors and stockholders vote all of their shares of Elicio capital stock: (i) in favor of adopting the Merger Agreement and approving the Merger, the Elicio
Stockholder Matters, and the other Contemplated Transactions, (ii) against any proposal made in opposition to, or in competition with, the Merger Agreement or the Merger and (iii) against any acquisition proposal involving a third party.
Lock-Up Agreements (see page 156)
Concurrently with the execution of the Merger Agreement,
(i) certain executive officers, directors, and stockholders of Elicio and (ii) certain directors of Angion, entered into lock-up agreements (Lock-Up Agreements), pursuant to which such persons accepted certain restrictions on transfers of the
shares of Angion common stock held by such persons for the 180-day period following the Effective Time.
Bridge Loan (see page 156)
In connection with execution of the Merger Agreement, Angion
made a bridge loan to Elicio pursuant to a note purchase agreement (Note Purchase Agreement) and promissory notes (Notes) up to an aggregate principal amount of $12.5 million, issued with a 20% original issue discount, with an initial closing
held substantially concurrently
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with the execution of the Merger Agreement for a principal amount of
$6.25 million on account of a $5.0 million loan and an additional closing for a principal amount of $6.25 million on account of a $5.0 million loan upon delivery by Elicio to Angion of Elicio’s audited financial statements for the year ended
December 31, 2022.
For a description of the Note Purchase Agreement and the Notes,
please see the section titled “Agreements Related to the Merger—Bridge Loan.”
Appraisal Rights (see page 148)
Angion stockholders are not entitled to appraisal rights in
connection with the Merger. Holders of Elicio common stock are entitled to appraisal rights in connection with the Merger under Section 262 of the DGCL. For more information about such rights, please see the provisions of Section 262 of the
DGCL attached as Annex C and the section titled “The Merger Agreement—Appraisal Rights and Dissenters’ Rights” beginning on page 148 of
this proxy statement/prospectus/information statement.
Management Following the Merger (see
page 263)
Immediately following the Merger, the executive management team
of the combined company is expected to comprise the following individuals with such additional officers as may be added by Elicio or the combined company:
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Name
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Position with the Combined Company
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Current Position at Elicio
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Robert Connelly
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Chief Executive Officer, President and Director
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Chief Executive Officer
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Daniel Geffken
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Interim Chief Financial Officer
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Interim Chief Financial Officer
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Christopher Haqq, M.D., Ph.D.
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Executive Vice President, Head of Research and Development and Chief Medical
Officer
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Executive Vice President, Head of Research and Development and Chief Medical
Officer
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Annette Matthies, Ph.D.
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Chief Business Officer
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Chief Business Officer
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Peter DeMuth, Ph.D.
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Chief Scientific Officer
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Chief Scientific Officer
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Directors of the Combined Company Following the
Merger
At the Effective Time, the combined company is expected to
initially have a nine-member board of directors, comprised of (a) Robert Connelly, Julian Adams, Ph.D., Carol Ashe, Yekaterina (Katie) Chudnovsky, Daphne Karydas, and Assaf Segal each as an Elicio designee and (b) Jay Venkatesan, M.D., MBA,
Karen J. Wilson, and Allen R. Nissenson, M.D., each as an Angion designee, until their respective successors are duly elected or appointed and qualified or their earlier death, resignation or removal.
The aforementioned board of directors will have an audit
committee, a compensation committee and a nominating and corporate governance committee, in accordance with the Nasdaq rules. All of Angion’s current directors, other than Dr. Venkatesan, Karen J. Wilson and Allen R. Nissenson, M.D., are
expected to resign from their positions as directors of Angion, effective as of the Effective Time.
Interests of Certain Directors and
Executive Officers of Angion and Elicio in the Merger (see pages 121 and 124)
In considering the recommendation of the Angion Board with
respect to the issuance of Angion common stock pursuant to the Merger Agreement and the other matters to be acted upon by Angion’s stockholders at the Angion special meeting, Angion’s stockholders should be aware that certain members of the
Angion Board and current and former executive officers of Angion have interests in the Merger that may be different from, or in addition to, interests they have as Angion’s stockholders.
On January 13, 2023, the Angion Board adopted the Angion
Biomedica Corp. Retention Bonus Plan (Retention Bonus Plan), providing for the payment of a cash retention bonus equal to 100% of a participant’s base salary, 65% of which becomes earned and payable upon the occurrence of a corporate
triggering event (defined to include a change in control (as defined in Angion’s 2021 Incentive Award Plan), a reverse merger or a dissolution) and 35% of which becomes earned and payable three months after the occurrence of such corporate
triggering event, subject in each case to earlier payment upon the occurrence of a qualifying termination of the participant’s employment by
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Angion without “cause” or by the participant for “good reason,” each as defined
in the Retention Bonus Plan. Participants in the Retention Bonus Plan include Jay Venkatesan, M.D., Angion’s President, Chief Executive Officer and Chairman, and Jennifer Rhodes, Angion’s Executive Vice President, Chief Business Officer,
General Counsel, Chief Compliance Officer and Secretary. Upon the earlier of a corporate triggering event or a qualifying termination, time-based equity awards will vest in full, the post-termination exercise period of options held by the
participant will be extended by four years (but no later than the original term of the option) and participants will receive an additional lump sum cash payment (approximately $1,464,000 in the case of Dr. Venkatesan and $642,000 in the case
of Ms. Rhodes, in each case less applicable withholding). Participants will no longer have the right to receive any payments under Angion’s Executive Separation Benefits Plan. The receipt of payments under the Retention Bonus Plan is subject
to the execution of a general release of claims by the participant. Concurrently, the Angion Board approved modifications of the Angion stock options held by Gregory Curhan, Angion’s Chief Financial Officer, such that, upon the earlier of a
corporate triggering event or a qualifying termination and subject to Mr. Curhan’s execution of a general release of claims, one option granted in 2022 will vest in full and the post-termination exercise period of all options will be extended
by four years (but no later than the original term of the option).
As of December 31, 2022, Angion’s directors and executive
officers (including affiliates) beneficially owned, in the aggregate approximately 19.3% of the outstanding shares of Angion common stock. As of December 31, 2022, Angion’s named executive officers and directors collectively owned unvested
stock options to purchase 1,058,612 shares of Angion common stock and vested stock options to purchase 2,231,678 shares of Angion common stock. All outstanding and unexercised options to purchase shares of Angion common stock will remain
effective and outstanding.
The compensation arrangements with Angion’s officers and
directors are discussed in greater detail in the section titled “The Merger—Interests of the Angion Directors and Executive Officers in the Merger” beginning on page 121 of this
proxy statement/prospectus/information statement. Additionally, as described elsewhere in this proxy statement/prospectus/information statement, including in the section captioned “Management Following the
Merger” beginning on page 263 of this proxy statement/prospectus/information statement, one of Angion’s directors is expected to become the director of the combined company upon the closing of the Merger.
In considering the recommendation of the Elicio Board with
respect to adopting the Merger Agreement, Elicio’s stockholders should be aware that members of the Elicio Board and the executive officers of Elicio may have interests in the Merger that may be different from, or in addition to, the
interests of Elicio’s stockholders. The Elicio Board was aware of these potential conflicts of interest and considered them, among other matters, in reaching its decision to approve the Merger Agreement, the Merger, and the Contemplated
Transactions.
As described elsewhere in this proxy
statement/prospectus/information statement, including in the section titled “The Merger—Management Following the Merger,” certain of Elicio’s directors and executive officers are expected to become the
directors and executive officers of the combined company upon the closing of the Merger.
Angion’s executive officers and directors, and Elicio’s
executive officers, directors and certain affiliated stockholders have entered into the Support Agreements, pursuant to which such directors, officers and certain stockholders, respectively, have agreed, solely in their capacity as
stockholders of Angion and Elicio, respectively, to vote all of their shares of Angion common stock or Elicio capital stock in favor of, among other things, the adoption or approval, respectively, of the Merger Agreement and the transactions
contemplated therein in connection with the Merger. The Support Agreements are discussed in greater detail in the section titled “Agreements Related to the Merger” beginning on page 156
of this proxy statement/prospectus/information statement.
Risk Factors and Risk Factor
Summary (see page 20)
Both Angion and Elicio are subject to various risks associated
with their businesses and their industries. In addition, the Merger, including the possibility that the Merger may not be completed, poses a number of risks to each company and its respective stockholders. You should carefully read this proxy
statement/prospectus/information statement, including the annexes, and especially consider the material risks discussed below and these and other risks discussed in greater detail under the section titled “Risk
Factors” beginning on page 20 of this proxy statement/prospectus/information statement. Angion and Elicio encourage you to read and consider all of these risks carefully.
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Risks Related to the Merger
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The Exchange Ratio is not adjustable based on the market price of Angion common stock so the consideration at the closing
of the Merger may have a greater or lesser value than at the time the Merger Agreement was signed;
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•
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Angion’s net cash may be less than $26.5 million at the Closing, which would result in Angion’s stockholders owning a
smaller percentage of the combined organization and, if Angion’s net cash is less than $25.0 million as of the End Date (as defined below), could even result in the termination of the Merger Agreement;
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Failure to complete the Merger may result in Angion or Elicio paying a termination fee to the other party and could harm
the common stock price of Angion and future business and operations of each company;
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If the conditions to the closing of the Merger are not met, the Merger may not occur;
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Lawsuits have been filed, and additional lawsuits may be filed, relating to the Merger. An adverse ruling in any such
lawsuit may prevent the Merger from being consummated;
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The Merger may be completed even though material adverse changes may result from the announcement of the Merger,
industry-wide changes and/or other causes;
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Some executive officers and directors of Angion and Elicio have interests in the Merger that are different from the
respective stockholders of Angion and Elicio and that may influence them to support or approve the Merger without regard to the interests of the respective stockholders of Angion and Elicio;
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The market price of Angion common stock following the Merger may decline as a result of the Merger;
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Angion and Elicio securityholders will have a reduced ownership and voting interest in, and will exercise less influence
over the management of, the combined company following the closing of the Merger as compared to their current ownership and voting interest in the respective companies;
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During the pendency of the Merger, Angion and Elicio may not be able to enter into a business combination with another
party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses;
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Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including
proposals that may be superior to the arrangements contemplated by the Merger Agreement;
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Because the lack of a public market for Elicio capital stock makes it difficult to evaluate the fairness of the Merger, the
shareholders of Elicio may receive consideration in the Merger that is less than the fair market value of Elicio capital stock and/or Angion may pay more than the fair market value of Elicio’s capital stock;
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The opinion delivered by Oppenheimer to the Angion Board prior to the entry into the Merger Agreement does not reflect
changes in circumstances that may have occurred since the date of the opinion;
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The Financial Projections included in the section titled “The Merger—Certain Unaudited
Financial Projections,” which were considered by the Angion Board in evaluating the Merger and used by Oppenheimer in rendering its opinion and performing its related financial analyses, reflect numerous variables, estimates
and assumptions and are inherently uncertain. If any of these variables, estimates and assumptions prove to be wrong, such as the assumptions relating to the approval of Elicio’s product candidates, the actual results for Elicio’s
business may be materially different from the results reflected in the Financial Projections;
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The Merger may fail to qualify as a reorganization for U.S. federal income tax purposes, resulting in recognition of
taxable gain or loss by Elicio stockholders who are U.S. Holders in respect of their Elicio capital stock;
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The combined organization may become involved in securities class action litigation that could divert management’s
attention and harm the combined organization’s business and insurance coverage may not be sufficient to cover all costs and damages; and
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If any of the events described in under the section titled “Risk Factors—Risks Related to
the Merger” occur, those events could cause the potential benefits of the Merger not to be realized.
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Risks Related to Angion
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Angion’s recent organizational changes and cost cutting measures may not be successful;
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Angion may not be able to comply with Nasdaq’s continued listing standards;
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Angion has temporarily suspended its clinical programs and has no products approved for sale, which makes it difficult to
assess its future viability;
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To achieve Angion’s goals it will require substantial additional funding, which capital may not be available to Angion on
acceptable terms, or at all, and, if not so available, may require Angion to delay, limit, reduce or cease operations and
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Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity,
defaults or non-performance by financial institutions could adversely affect Angion’ current financial condition and projected business operations.
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Risks Related to Elicio
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Elicio has a history of operating losses that are expected to continue for the foreseeable future, and it is unable to
predict the extent of future losses, or whether it will generate significant revenues or achieve or sustain profitability;
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Elicio will require substantial additional capital to finance its operations, and a failure to obtain this necessary
capital when needed on acceptable terms, or at all, could force it to delay, limit, reduce or terminate its research and development programs, commercialization efforts or cease operations;
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Elicio has never generated revenue from product sales and may never become profitable;
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Elicio’s product candidates are at an early stage of development and may not be successfully developed or commercialized;
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The FDA regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and Elicio may experience
significant delays in the clinical development and regulatory approval, if any, of its product candidates;
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If any product candidate that Elicio successfully develops does not achieve broad market acceptance among physicians,
patients, health care payors and the medical community, the revenues that it generates from their sales will be limited; and
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Elicio’s success will depend upon intellectual property and proprietary technologies, and it may be unable to protect its
intellectual property.
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Risks Related to the Combined Company
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The combined company will need to raise additional financing in the future to fund its operations, which may not be
available to it on favorable terms or at all;
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The market price of the combined company’s common stock is expected to be volatile, and the market price of the common
stock may drop following the Merger;
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The combined company will incur costs and demands upon management as a result of complying with the laws, rules and
regulations affecting public companies; and
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Anti-takeover provisions in the combined company’s charter documents and under Delaware law could make an acquisition of
the combined company more difficult and may prevent attempts by the combined company stockholders to replace or remove the combined company management.
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Regulatory Approvals (see page 128)
In the United States, Angion must comply with applicable federal
and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of Angion common stock to Elicio’s stockholders in
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connection with the transactions contemplated by the Merger Agreement and the
filing of this proxy statement/prospectus/information statement with the SEC. Angion does not intend to seek any regulatory approval from antitrust authorities to consummate the Contemplated Transactions.
Nasdaq Stock Market Listing (see
page 131)
Shares of Angion common stock are currently listed on The Nasdaq
Global Select Market under the symbol “ANGN.” Elicio has filed an initial listing application with Nasdaq pursuant to Nasdaq’s “reverse merger” rules. After completion of the Merger, Angion will be renamed “Elicio Therapeutics, Inc.” and
expects to trade on The Nasdaq Global Market under the symbol “ELTX.” Under the Merger Agreement, each of Elicio’s and Angion’s obligation to complete the Merger is subject to the satisfaction or waiver by each of the parties, at or prior to
the Merger, of various conditions, including that the shares of Angion common stock to be issued in the Merger have been approved for listing (subject to official notice of issuance) on Nasdaq as of the closing of the Merger. The terms of the
Merger Agreement permit that this condition may be waived by agreement among Elicio, Angion and Merger Sub, without recirculation or resolicitation of this proxy statement/prospectus/information statement.
Anticipated Accounting Treatment
(see page 131)
The Merger will be treated by Angion as a reverse
recapitalization under U.S. generally accepted accounting principles (GAAP). For accounting purposes, Elicio is considered to be the accounting acquirer in this transaction.
Description of Angion and Elicio
Capital Stock (see page 294)
Both Angion and Elicio are incorporated under the laws of the
State of Delaware and, accordingly, the rights of the stockholders of each are currently, and will continue to be, governed by the DGCL. If the Merger is completed, Elicio stockholders will become Angion stockholders, and their rights will be
governed by the DGCL, the amended and restated bylaws of Angion and the amended and restated certificate of incorporation of Angion, as may be amended by the Reverse Stock Split Proposal and the Exculpation Proposal if approved by the Angion
stockholders at the Angion special meeting. The rights of Angion stockholders contained in Angion’s amended and restated certificate of incorporation, and amended and restated bylaws differ from the rights of Elicio stockholders under
Elicio’s current amended and restated certificate of incorporation and bylaws, as more fully described under the section titled “Comparison of Rights of Holders of Angion Stock and Elicio Stock”
beginning on page 294 of this proxy statement/prospectus/information statement.
Angion Stockholder Meeting (see page
93)
The Angion special meeting will be held exclusively online
via audio-only webcast on May 31, 2023 at 9:00 a.m. Pacific Time, unless postponed or adjourned to a later date. The Angion special meeting can be accessed by visiting www.virtualshareholdermeeting.com/ANGN2023SM, where you will be able to
vote your shares and submit questions during the Angion special meeting webcast by logging in to the website listed above using the 16-digit control number included in your proxy card. Online check-in will begin at 8:45 a.m. Pacific Time,
and Angion encourages you to allow ample time for the online check-in procedures. Please note that you will not be able to attend the Angion special meeting in person. For more information on the Angion special meeting, see the section
titled “The Special Meeting of Angion’s Stockholders” beginning on page 93 of this proxy statement/prospectus/ information statement.
Angion common stock is currently listed on The Nasdaq Global
Select Market under the symbol “ANGN.” Elicio is a private company and its common stock and preferred stock are not publicly traded.
The closing price of Angion common stock on January 13, 2023,
the trading day immediately prior to the public announcement of the Merger on January 17, 2023, as reported on The Nasdaq Global Select Market, was $1.02 per share. The closing price of Angion common stock on March 28, 2023, as reported on
The Nasdaq Global Select Market, was $0.48 per share.
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Because the market price of Angion common stock is subject to
fluctuation, the market value of the shares of Angion common stock that Elicio stockholders will be entitled to receive in the Merger may increase or decrease.
Assuming successful application for initial listing with Nasdaq,
following the consummation of the Merger, Angion anticipates that the Angion common stock will trade under Angion’s new name “Elicio Therapeutics, Inc.” and the new trading symbol “ELTX” on The Nasdaq Global Market.
As of , 2023, the record date for the Angion special meeting,
there were approximately 120 holders of record of the Angion common stock.
Angion has never declared or paid any cash dividends on the
Angion common stock and does not anticipate paying cash dividends on Angion common stock for the foreseeable future. Notwithstanding the foregoing, any determination to pay cash dividends subsequent to the Merger will be at the discretion of
the combined organization’s then-current board of directors and will depend upon a number of factors, including the combined organization’s results of operations, financial condition, future prospects, contractual restrictions, restrictions
imposed by applicable law and other factors the then-current board of directors deems relevant.
Elicio has never declared or paid any cash dividends on shares
of the Elicio capital stock except for $2,645,438 accrued and unpaid dividends on its Series A Preferred Stock. Elicio anticipates that the combined company will retain all of its future earnings to advance the clinical trials for its product
candidates, and does not anticipate paying any cash dividends on shares of its common stock in the foreseeable future. Any future determination to declare cash dividends on shares of the combined company’s common stock will be made at the
discretion of its board of directors, subject to applicable law and contractual restrictions and will depend on its financial condition, results of operations, capital requirements, general business conditions and other factors that its board
of directors may deem relevant.
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The combined company will be faced with a
market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus/ information statement, you should
carefully consider the material risks described below before deciding how to vote your shares of Angion common stock. In addition, you should read and consider the risks associated with the business of Angion because these risks may also affect
the combined company. These risks can be found in Angion’s Annual Report on Form 10-K, as updated by subsequent Quarterly Reports on Form 10-Q, all of which are filed with the SEC. You should also read and consider the other information in this
proxy statement/prospectus/information statement. Realization of any of the risks described below, any of the uncertainties described under “Cautionary Statement Regarding Forward-Looking Statements” could have a material adverse effect on
Angion’s, Elicio’s or the combined company’s businesses, financial condition, cash flows and results of operations. Please see the section titled “Where You Can Find More Information” beginning on page 307 of this proxy
statement/prospectus/information statement.
The Exchange Ratio is not adjustable based
on the market price of Angion common stock so the consideration at the closing of the Merger may have a greater or lesser value than at the time the Merger Agreement was signed.
The relative proportion of the combined company that the Angion
stockholders will own when the Merger closes will be based on the relative valuations of Angion and Elicio as negotiated by the parties and as specified in the Merger Agreement. Immediately following the Merger, the pre-Merger equity holders of
Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each
case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. The Exchange Ratio formula is derived based upon an Elicio fixed valuation of $95 million and an
Angion valuation of $50.1 million, subject to certain adjustments, including based upon Angion Net Cash at Closing. The calculation of Angion Net Cash at Closing includes, among other things, a credit for cash proceeds Angion receives from the
sale, transfer, license, assignment or other divestiture of its intellectual property and other assets and technology in existence on the date of the Merger Agreement prior to or substantially concurrently with the Closing and a reduction for
certain liabilities. The Net Cash Condition means that Angion Net Cash must be no less than $25 million in order for Elicio to be required to complete the Merger. For a more complete description of the Merger and the potential adjustments in
the Exchange Ratio, please see the section titled “The Merger Agreement —Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy statement/prospectus/information
statement. In addition, if the Net Cash Condition is not satisfied as of the End Date, Elicio has the right to terminate the Merger Agreement.
Angion’s net cash may be less than
$26.5 million at the Closing, which would result in Angion’s stockholders owning a smaller percentage of the combined organization and, if Angion’s net cash is less than $25.0 million as of the End Date, could even result in the termination of
the Merger Agreement
For purposes of the Merger Agreement, net cash is subject to
certain reductions, including, without limitation, accounts payable, accrued expenses (except those related to the Merger), current liabilities payable in cash, unpaid expenses related to the Merger and certain other unpaid obligations,
including outstanding lease obligations. In the event the amount of Angion’s cash is smaller or such reductions are greater than anticipated, Angion stockholders could hold a significantly smaller portion of the combined organization.
Failure to complete the Merger may result in
Angion or Elicio paying a termination fee to the other party and could harm the common stock price of Angion and future business and operations of each company.
If the Merger is not completed, each of Angion and Elicio is subject
to the following risks:
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upon termination of the Merger Agreement, Angion may be required to pay Elicio a termination fee of $2.0 million or
$1.0 million, under certain circumstances, and/or up to $500,000 in expense reimbursements; or Elicio may be required to pay Angion a termination fee of $1.0 million, under certain circumstances, and/or up to $500,000 in expense
reimbursements;
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the parties will have incurred significant expenses related to the Merger, such as legal and accounting fees, which must be
paid even if the Merger is not completed;
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the price of Angion’s common stock may decline and remain volatile; and
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Angion may be forced to cease its operations, dissolve and liquidate its assets.
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In addition, if the Merger Agreement is terminated and the Angion
Board or Elicio Board determines to seek another business combination, there can be no assurance that either Angion or Elicio will be able to find a partner willing to provide equivalent or more attractive consideration than the consideration
to be provided by each party in the Merger or any partner at all.
If the conditions to the closing of the Merger
are not met, the Merger may not occur.
Even if the Stock Issuance Proposal is approved by the
stockholders of Angion, specified conditions must be satisfied or waived to complete the Merger. These conditions are set forth in the Merger Agreement and described in the section titled “The Merger
Agreement—Conditions to the Completion of the Merger” beginning on page 139 of this proxy statement/prospectus/information statement. Angion and Elicio cannot assure you that all of the conditions will be satisfied
or waived. If the conditions are not satisfied or waived, the Merger may not occur or will be delayed, and Angion and Elicio each may lose some or all the intended benefits of the Merger.
Lawsuits have been filed, and additional
lawsuits may be filed, relating to the Merger. An adverse ruling in any such lawsuit may prevent the Merger from being consummated.
Following the announcement of Angion’s entry into the Merger
Agreement with Elicio on January 17, 2023, and the initial filing of this Registration Statement on February 13, 2023, a lawsuit was filed in the United States District Court for the Eastern District of New York on February 17, 2023 by a
purported stockholder of Angion in connection with the Merger. The lawsuit was captioned Klein v. Angion Biomedica Corp., et al., No. 1:23-cv-01313 (E.D.N.Y.). The Klein complaint named as defendants Angion, and the members of the Angion Board.
The Klein complaint alleged claims for breaches of fiduciary duty against the members of the Angion Board, aiding and abetting breaches of fiduciary duty against Angion, violations of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated
thereunder against all defendants, and violations of Section 20(a) of the Exchange Act against the members of the Angion Board. The plaintiff contended that the registration statement on Form S-4 filed on February 13, 2023 omitted or
misrepresented material information regarding the Merger, rendering the Registration Statement false and misleading. The Klein complaint sought injunctive and declaratory relief, as well as damages. On February 21, 2023, the plaintiff filed a
notice of voluntary dismissal of the Klein lawsuit. Although the plaintiffs voluntarily dismissed this case, litigation of this type is prevalent in mergers involving public companies, and other potential plaintiffs may file lawsuits
challenging the Merger.
The outcome of any additional future litigation is uncertain. Such
litigation, if not resolved, could prevent or delay completion of the Merger and result in substantial costs to Angion, including any costs associated with the indemnification of directors and officers. One of the conditions to the completion
of the Merger is the absence of any law or order from a governmental entity (whether temporary, preliminary or permanent) that is in effect and restrains, enjoins or otherwise prohibits the consummation of the Merger. Therefore, if a plaintiff
were successful in obtaining an injunction prohibiting the consummation of the Merger on the agreed-upon terms, then such injunction may prevent the Merger from being completed, or from being completed within the expected timeframe. The defense
or settlement of any lawsuit or claim that remains unresolved at the time the Merger is completed may adversely affect the combined company’s business, financial condition, results of operations and cash flows. In addition, although Angion Net
Cash is increased by 50% of the aggregate costs associated with stockholder litigation brought or threatened in writing against Angion or its directors or officers related to the Contemplated Transactions, the other 50% of such costs would
reduce Angion Net Cash and may adversely affect Angion’s ability to meet the Net Cash Condition.
The Merger may be completed even though
material adverse changes may result from the announcement of the Merger, industry-wide changes and/or other causes.
In general, either Angion or Elicio can refuse to complete the
Merger if there is a material adverse change affecting the other party between January 17, 2023, the date of the Merger Agreement, and the closing of the Merger. However, certain types of changes do not permit either party to refuse to complete
the Merger, even if such change could be said to have a material adverse effect on Angion or Elicio, including:
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general business or economic conditions generally affecting the industry in which Elicio or Angion operate;
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acts of war, the outbreak or escalation of armed hostilities, acts of terrorism, earthquakes, wildfires, hurricanes or other
natural disasters, health emergencies, including pandemics (including COVID-19 and any evolutions or mutations thereof) and related or associated epidemics, disease outbreaks or quarantine restrictions;
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changes in financial, banking or securities markets;
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any change in the stock price or trading volume of Angion common stock;
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any failure by Angion to meet internal or analysts’ expectations or projections or the results of operations of Angion;
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any change in or affecting clinical trial programs or studies conducted by or on behalf of Angion or its subsidiaries;
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any change from continued losses from operations or decreases in cash balances of Elicio or any of its subsidiaries or on a
consolidated basis among Elicio and its subsidiaries;
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any change in, or any compliance with or action taken for the purpose of complying with, any law or GAAP (or interpretations
of any law or GAAP); or
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any change resulting from the announcement of the Merger Agreement or the pendency of the Contemplated Transactions;
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the taking of any action required to be taken by the Merger Agreement; or
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any reduction in the Angion’s cash and cash equivalents as a result of winding down its activities associated with the
termination of its research and development activities.
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If adverse changes occur and Angion and Elicio still complete the
Merger, the stock price of the combined company following the closing of the Merger may suffer. This in turn may reduce the value of the Merger to the stockholders of Angion, Elicio or both.
Some executive officers and directors of
Angion and Elicio have interests in the Merger that are different from the respective stockholders of Angion and Elicio and that may influence them to support or approve the Merger without regard to the interests of the respective stockholders
of Angion and Elicio.
Some officers and directors of Angion and Elicio are parties to
arrangements that provide them with interests in the Merger that are different from the respective stockholders of Angion and Elicio, including, among others, service as an officer or director of the combined company following the closing of
the Merger, severance and retention benefits, the acceleration of equity award vesting, and continued indemnification. For more information regarding the interests of the Angion and Elicio executive officers and directors in the Merger, see the
sections titled “The Merger—Interests of the Angion Directors and Executive Officers in the Merger” and “The Merger—Interests of the Elicio Directors and Executive Officers in the Merger” of this proxy statement/prospectus/information statement.
The market price of Angion common stock
following the Merger may decline as a result of the Merger.
The market price of Angion common stock may decline as a result of
the Merger for a number of reasons, including if:
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investors react negatively to the prospects of the combined company’s business and prospects following the closing of the
Merger;
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the effect of the Merger on the combined company’s business and prospects following the closing of the Merger is not
consistent with the expectations of financial or industry analysts; or
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the combined company does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by
stockholders or financial or industry analysts.
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Angion and Elicio securityholders will have
a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the closing of the Merger as compared to their current ownership and voting interest in the respective
companies.
Immediately following the Merger, the pre-Merger equity holders of
Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected
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to hold approximately 34.5% of the outstanding shares of Angion common stock, in
each case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. These estimates are based on the anticipated Exchange Ratio and are subject to adjustment
as provided in the Merger Agreement. A $25.0 million Angion Net Cash threshold is a condition to the completion of the Merger. For a more complete description of the Merger and the potential adjustments in the Exchange Ratio, please see the
section titled “The Merger Agreement—Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy statement/prospectus/information statement.
In addition, the nine-member board of directors of the combined
company will initially consist of six individuals with prior affiliations with Elicio and three individuals with prior affiliation with Angion. Consequently, securityholders of Elicio and Angion will be able to exercise less influence over the
management and policies of the combined company following the closing of the Merger than they currently exercise over the management and policies of their respective companies.
During the pendency of the Merger Agreement,
Angion and Elicio may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.
Covenants in the Merger Agreement impede the ability of Angion and
Elicio to make acquisitions, subject to specified exceptions relating to fiduciary duties, or complete other mergers, sales of assets or other business combinations that are not in the ordinary course of business pending completion of the
Merger. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting,
initiating, encouraging or entering into specified extraordinary transactions, such as a merger, sale of assets or other business combination, with any third party, subject to specified exceptions, even if any such transaction could be
favorable to such party’s stockholders.
Certain provisions of the Merger Agreement
may discourage third parties from submitting competing proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.
The terms of the Merger Agreement prohibit each of Angion and
Elicio from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances when such party’s board of directors determines in good faith, after consultation with its outside
financial advisor and outside counsel, that an unsolicited competing proposal constitutes, or is reasonably likely to result in, a superior competing proposal and, after consultation with its outside counsel, that failure to take such action is
reasonably likely to be inconsistent with the fiduciary duties of the applicable board of directors. In addition, if Angion or Elicio terminate the Merger Agreement under specified circumstances, including terminating because of a decision of
the Angion Board to recommend a superior competing proposal, Angion may be required to pay Elicio a termination fee of $2.0 million or $1.0 million or up to $500,000 in expense reimbursements or Elicio may be required to pay Angion a
termination fee of $1.0 million, or up to $500,000 in expense reimbursements, as defined and described under “The Merger Agreement—Termination of the Merger Agreement and Termination Fee.” This
termination fee may discourage third parties from submitting competing proposals to Angion or its stockholders and may cause the Angion Board to be less inclined to recommend a competing proposal.
Because the lack of a public market for
Elicio’s capital stock makes it difficult to evaluate the fairness of the Merger, the shareholders of Elicio may receive consideration in the Merger that is less than the fair market value of Elicio’s capital stock and/or Angion may pay more
than the fair market value of Elicio’s capital stock.
The outstanding capital stock of Elicio is privately held and is
not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Elicio’s capital stock. Because the percentage of Angion equity to be issued to Elicio shareholders was determined
based on negotiations between the parties, it is possible that the value of the Angion common stock to be received by Elicio shareholders will be less than the fair market value of Elicio’s capital stock, or Angion may pay more than the
aggregate fair market value for Elicio’s capital stock.
The opinion delivered by Oppenheimer to the
Angion Board prior to the entry into the Merger Agreement does not reflect changes in circumstances that may have occurred since the date of the opinion.
The Angion Board has not obtained an updated opinion either as of
the date of this proxy statement/prospectus/information statement or as of any other date subsequent to the date of the opinion from Oppenheimer, Angion’s financial advisor. Changes in circumstances, including in the operations and prospects of
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Angion or Elicio, stock prices, general market and economic conditions and other
factors, some or all of which may be beyond the control of Angion and Elicio, including the recent increases in inflation and lending rates that have caused higher than normal volatility in the financial markets generally, are not reflected in
its opinion. The opinion does not speak as of any date other than the date of the opinion.
The Financial Projections for Elicio
included in the section titled “The Merger—Certain Unaudited Financial Projections”, which were considered by the Angion Board in evaluating the Merger and used by Oppenheimer in rendering its opinion and performing its related financial
analyses, reflect numerous variables, estimates and assumptions and are inherently uncertain. If any of these variables, estimates and assumptions prove to be wrong, such as the assumptions relating to the approval of Elicio’s product
candidates, the actual results for Elicio’s business may be materially different from the results reflected in the Financial Projections.
As further described below in the section titled “The Merger—Certain Unaudited Financial Projections”, in connection with the Angion Board’s evaluation of the Merger, preliminary internal financial forecasts for Elicio were prepared by the management of
Elicio and provided to the management of Angion, and then adjusted by the management of Angion, solely for use by Angion’s financial advisor, Oppenheimer, in connection with the rendering of its opinion and performing its related financial
analyses, as described below under “The Merger—Opinion of Angion’s Financial Advisor”. The Financial Projections reflect numerous variables, estimates, and forecasts made by Angion’s and Elicio’s
respective management at the time the initial financial forecasts were prepared by Elicio and adjusted by Angion. If any of these variables, estimates and assumptions prove to be wrong, the actual results for Elicio’s business may differ
materially from the results reflected in the Financial Projections.
The estimated probabilities of success included in the Financial
Projections take into account a range of potential outcomes, including outcomes in which product candidates fail to achieve commercial launch due to commercial and regulatory uncertainty (including failure to obtain regulatory authorization to
market the applicable product candidate) as well as economic and portfolio management decisions and competition, and these assumptions, including those with respect to regulatory approval and probability of success more broadly, are inherently
uncertain and could prove inaccurate. If ELI-002 does not receive marketing authorization when anticipated, for the indications anticipated, or at all, the actual results of the combined company’s business will differ materially from the
results reflected in the Financial Projections. For example, while the Financial Projections reflect the probability of success assessments described below in the section titled “The Merger—Certain Unaudited
Financial Projections” for ELI-002, if ELI-002 is not approved then actual results will differ materially, including the potential for ELI-002 to generate no revenue at all.
In addition, the Financial Projections cover a significant period
of time, specifically through 2039. This extended period was used in light of the anticipated timing for regulatory approval and the initiation of commercial sales of ELI-002. However, the risks and uncertainties regarding the Financial
Projections, including the potential for adverse developments such as delays in obtaining or failure to obtain regulatory approvals or additional competition or changes in the competitive or regulatory landscape, increase with each successive
year and the likelihood that the actual results will differ materially from the projected results increase with each successive year. The Financial Projections also do not reflect general business, economic, market and financial conditions and
any changes in any of these conditions over the period of the projections could result in the actual results differing materially from the results reflected in the Financial Projections.
The Merger may fail to qualify as a
reorganization for U.S. federal income tax purposes, resulting in recognition of taxable gain or loss by Elicio stockholders who are U.S. holders in respect of their Elicio capital stock.
Angion and Elicio intend for the Merger to qualify as a
reorganization within the meaning of Section 368(a) of the Code, as described in the section titled “The Merger—Material U.S. Federal Income Tax Consequences of the Merger” in this proxy
statement/prospectus/information statement, and, subject to the limitations and qualifications described therein, in the opinion of Cooley LLP and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. the Merger will qualify as a reorganization
within the meaning of Section 368(a) of the Code.
In the event that the Merger does not qualify as a reorganization,
the Merger would result in taxable gain or loss for each Elicio stockholder who is a U.S. holder, with the amount of such gain or loss determined by the amount that each such Elicio stockholder's adjusted tax basis in the Elicio capital stock
surrendered is less or more than the fair market value of the Angion common stock and any cash in lieu of a fractional share received in exchange therefor. Each holder of Elicio capital stock is urged to consult with his, her or its own tax
advisor with respect to the tax consequences of the Merger.
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The combined organization may become
involved in securities class action litigation that could divert management's attention and harm the combined organization's business and insurance coverage may not be sufficient to cover all costs and damages.
In the past, securities class action or shareholder derivative
litigation often follows certain significant business transactions, such as the sale of a business division or announcement of a Merger. The combined organization may become involved in this type of litigation in the future. Litigation often is
expensive and diverts management's attention and resources, which could adversely affect the combined organization's business.
Angion
or Elicio may waive one or more of the conditions to the Merger without recirculation of this proxy statement/prospectus/information statement or resoliciting stockholder approval.
Conditions to Angion’s or Elicio’s obligations to complete the
Merger may be waived, in whole or in part, to the extent permitted by law, either unilaterally or by agreement of Angion, Elicio and Merger Sub. In the event of a waiver of a condition, the Angion Board will evaluate the materiality of any such
waiver to determine whether amendment of this proxy statement/prospectus/information statement and resolicitation of stockholder approval is necessary.
In the event that the Angion Board, in its own reasonable
discretion, determines any such waiver is not significant enough to require recirculation of this proxy statement/prospectus/information statement and re-solicitation of its stockholders, it will have the discretion to complete the Merger
without seeking further stockholder approval, which decision may have a material adverse effect on the Angion stockholders. For example, if Angion and Elicio agree to waive the requirement that the shares of Angion common stock to be issued in
the Merger have been approved for listing (subject to official notice of issuance) on Nasdaq as of the closing of the Merger, and their respective boards of directors elect to proceed with the closing of the Merger, Nasdaq may notify the
combined company of its determination to delist the company’s securities based upon the failure to satisfy the initial inclusion criteria in the Nasdaq application. The combined company may appeal the determination to a hearings panel, which
will stay the delisting action pending a panel decision. If the combined company does not appeal the determination, its common stock will be delisted.
For more information about the conditions to the completion of the
Merger, see the section titled “The Merger Agreement–Conditions to the Completion of the Merger.”
Nasdaq may delist the combined company’s
securities from trading on its exchange, which could limit investors’ ability to make transactions in its securities and subject the combined company to additional trading restrictions.
Currently, Angion’s common stock is publicly traded on Nasdaq. In
connection with the proposed Merger, Elicio has filed an initial listing application with Nasdaq pursuant to Nasdaq’s “reverse merger” rules. The combined company will be required to meet the initial listing requirements for its securities to
be listed on Nasdaq.
If Angion and Elicio fail to meet the Nasdaq listing requirements
and their respective boards choose to close the merger without Nasdaq’s approval then Nasdaq may notify the combined company of its determination to delist the company’s securities based upon the failure to satisfy the criteria in the Nasdaq
application. For more information, refer to the section titled “Risk Factors Related to the Merger—Angion or Elicio may waive one or more of the conditions to the Merger without recirculation of this proxy
statement/prospectus/information statement or resoliciting stockholder approval” beginning on page 25 of this proxy statement/prospectus/information statement.
We cannot assure you that the combined company will be able to
meet those initial listing requirements. Even if the combined company’s securities are so listed, the combined company may be unable to maintain the listing of its securities in the future. In order to continue listing its securities on Nasdaq
following the proposed Merger, the combined company will be required to maintain certain financial, distribution and stock price levels. If Nasdaq delists the combined company’s securities from trading on its exchange at closing of the Merger
(or thereafter) and the combined company is not able to list its securities on another national securities exchange or regain compliance with Nasdaq, the combined company’s securities could be quoted on an over-the-counter market. If this were
to occur, the combined company could face significant material adverse consequences, including:
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a limited availability of market quotations for its securities;
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reduced liquidity for its securities;
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a determination that the combined company’s common stock is a “penny stock” which will require brokers trading in the
combined company’s common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;
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a limited amount of news and analyst coverage; and
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a decreased ability to issue additional securities or obtain additional financing in the future.
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The National Securities Markets Improvement Act of 1996, which is
a federal statute, prevents or preempts states from regulating the sale of certain securities, which are referred to as “covered securities.” Since Angion’s common stock is listed on Nasdaq, they are covered securities. Although states are
preempted from regulating the sale of covered securities, the federal statute does allow states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then states can regulate or bar the
sale of covered securities in a particular case. If Angion was no longer listed on Nasdaq, its securities would not be covered securities and it would be subject to regulation in each state in which it offers its securities, including in
connection with the Merger.
Risks Relating to Angion’s 2022 Strategic Realignment
Angion’s recent organizational changes and cost
cutting measures may not be successful.
In July 2022, Angion implemented a reduction-in-force affecting a
majority of its workforce and a process to explore strategic options for enhancing and preserving shareholder value (2022 Strategic Realignment), which resulted in Angion and Elicio entering into the Merger Agreement. As of March 28, 2023,
Angion had only three employees. The reductions in workforce and cost cutting measures will make it difficult for it to resume development activities Angion has suspended or pursue new initiatives if it does not successfully complete the
Merger, requiring it to hire qualified replacement personnel, which may require it to incur additional and unanticipated costs and expenses. As a result of the loss of services of substantially all of Angion’s personnel, including several of
its executive officers, Angion may be unable to continue its operations and meet its ongoing obligations if it does not successfully complete the Merger. Any of these unintended consequences may have a material adverse impact on Angion’s
business, financial condition, and results of operations.
Angion may not be able to comply with Nasdaq’s
continued listing standards.
Angion common stock trades on The Nasdaq Global Select Market
under the symbol “ANGN.” There is also no guarantee Angion will be able to perpetually satisfy Nasdaq’s continued listing requirements to maintain its listing on Nasdaq for any periods of time. Among the conditions required for continued
listing on Nasdaq, Angion is required to maintain a stock price over $1.00 per share pursuant to Rule 5550(a)(2) of the Nasdaq Listing Rules. On December 15, 2022, Angion received a letter from Nasdaq notifying it that for the last 30
consecutive business days the bid price of Angion’s common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq listing rule 5450(a)(1). If Angion’s common stock does not
achieve compliance by June 13, 2023, Angion may be eligible for an additional 180-day period to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards,
with the exception of the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. However, if it appears to the
Nasdaq staff that Angion will not be able to cure the deficiency, or if Angion does not meet the other listing standards, Nasdaq could provide notice that Angion’s common stock will become subject to delisting. In the event Angion receives
notice that its common stock is being delisted, Nasdaq rules permit Angion to appeal any delisting determination.
In addition, even if Angion demonstrates compliance with the
requirement above, Angion will have to continue to meet other objective and subjective listing requirements to continue to be listed on Nasdaq, which it may not be able to continue to meet. Delisting from Nasdaq could make trading Angion common
stock more difficult for investors, potentially leading to declines in Angion’s share price and liquidity. Without a Nasdaq listing, stockholders may have a difficult time obtaining a quote for the sale or purchase of Angion common stock, the
sale or purchase of Angion common stock would likely be made more difficult, and the trading volume and liquidity of Angion common stock could decline. Delisting from Nasdaq could also result in negative publicity and could also make it more
difficult for Angion to raise additional capital.
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Risks Relating to Angion’s Financial Position and Need for
Additional Capital
Angion has temporarily suspended its clinical
programs and has no products approved for sale, which makes it difficult to assess its future viability.
Angion is a biopharmaceutical company that has suspended its
clinical programs, has only a small number of preclinical programs, and has no products approved for sale. Drug development is a highly speculative undertaking and involves a substantial degree of risk. Angion has not yet submitted any product
candidates for approval or received approval of any product candidate by regulatory authorities in any jurisdiction, including the FDA. Angion does not expect to generate revenue from product sales unless it, or its collaborators, resume
clinical development of Angion’s product candidates and obtain approval and commercialize its product candidates, which Angion does not expect to occur for several years, if ever. Angion expects to continue to incur net losses for the
foreseeable future to the extent it advances its product candidates through preclinical and clinical and development, and as it continues to incur expenses to protect its intellectual property, maintain its general and administrative support
functions, and incur costs associated with operating as a public company. If Angion is unable to enroll clinical trials for any of its product candidates, or it fails in clinical trials or does not gain regulatory approval, Angion may never
generate revenue or become profitable.
To achieve Angion’s goals it will require
substantial additional funding, which capital may not be available to Angion on acceptable terms, or at all, and, if not so available, may require Angion to delay, limit, reduce or cease operations.
Angion has invested and, to the extent it resumes clinical
development and clinical trials of its product candidates following its 2022 Strategic Realignment process, will continue to invest a significant portion of its efforts and financial resources in research and development activities. Developing
pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. Angion will require substantial additional future capital to complete clinical development, including additional clinical trials, and seek
regulatory approval to bring its product candidates to market. Regulatory authorities in the United States and elsewhere could also require Angion to perform additional preclinical studies or clinical trials to receive or maintain regulatory
approval of its product candidates, and its expenses would further increase beyond what Angion currently expects. Because successful development of Angion’s product candidates is uncertain, Angion is unable to estimate the actual funds it will
require to complete research and development of its product candidates as well as the costs of commercializing any of its wholly-owned product candidates and those for which Angion retains the right to commercialize.
In addition, whether or not Angion resumes clinical trials of its
product candidates, it will continue to incur costs:
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to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any
payments Angion may be required to make, or Angion may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, and
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the costs associated with being a public company, including Angion’s need to implement additional internal systems and
infrastructure, including financial and reporting systems.
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Adverse developments affecting the financial
services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions could adversely affect Angion’ current financial condition and projected business operations.
Actual events involving limited liquidity, defaults,
non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any
events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (SVB), where Angion held substantially all of its cash and cash
equivalents, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, (FDIC), as receiver. On March 12, 2023, the Department of the Treasury, the Federal Reserve,
and the FDIC jointly released a statement that depositors at SVB would have access to their funds, even those funds in excess of the standard FDIC insurance limits, under a systemic risk exception. As of March 13, 2023, Angion had access to its
cash and cash equivalents at SVB, and at the end of March 2023 transferred substantially all of its cash and cash equivalents from SVB to an asset manager and only held a small portion of its cash and cash equivalents in deposit accounts;
however, there is uncertainty in the markets regarding the stability of regional banks and the safety of
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deposits in excess of the FDIC insured deposit limits. The ultimate outcome of
these events cannot be predicted, but these events could have a material adverse effect on Angion’s business operations as well as its ability to complete the Merger.
Risks Relating to the Development and Regulatory Approval of
Angion’s Product Candidates
COVID-19 could adversely impact Angion’s
business, including any clinical trials and its financial condition.
Angion has been and continues to be subject to risks related to
public health crises such as the global pandemic associated with COVID-19. As COVID-19 continues to persist around the globe, to the extent Angion resumes clinical trials or commences new clinical trials, Angion may experience disruptions that
could severely impact its business and clinical trials, including:
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delays or difficulties in enrolling patients in clinical trials;
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delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and
clinical site staff;
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diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as
Angion’s clinical trial sites and hospital staff supporting the conduct of its clinical trials;
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interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed
or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the integrity of clinical trial data;
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the risk that participants enrolled in Angion’s clinical trials will acquire COVID-19 while the clinical trial is ongoing,
which could impact the results of the clinical trial, including by increasing the number of observed adverse events;
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limitations in employee resources that would otherwise be focused on the conduct of Angion’s clinical trials, including
because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
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delays in receiving authorizations from local regulatory authorities to initiate Angion’s planned clinical trials;
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delays in clinical sites receiving the supplies and materials needed to conduct Angion’s clinical trials;
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interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug
product used in Angion’s clinical trials;
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changes in local regulations as part of a response to the COVID-19 pandemic which may require Angion to change the ways in
which Angion’s clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
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interruptions or delays in preclinical studies due to restricted or limited operations at Angion’s research and development
laboratory facilities or at its third-party clinical research organizations;
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delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to
limitations in employee resources or forced furlough of government employees; and
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refusal of the FDA to accept data from clinical trials in affected geographies outside the United States.
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The global pandemic of COVID-19 continues to evolve. The extent to
which COVID-19 may impact Angion’s business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the geographic spread of the disease and its variants, business closures or business
disruptions, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.
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Product development and regulatory
approval involve a lengthy and expensive process with uncertain outcomes. Angion cannot be certain any of its product candidates will receive or maintain regulatory approval and, without regulatory approval, it and its collaborators will not be
able to market its product candidates.
Angion currently has suspended its clinical programs and has no
products approved for sale, and even if Angion resumes clinical trials Angion cannot guarantee it will ever have approved products it or its collaborators can market and sell. The development of a product candidate and issues relating to its
approval and marketing are subject to extensive regulation by regulatory authorities, including the FDA in the United States and other regulatory authorities in other foreign countries, with regulations differing from country to country. Angion
is not permitted to market its product candidates in the United States or elsewhere until it receives regulatory approval and/or marketing authorization, such as approval of a New Drug Application (NDA) from the FDA. Angion has not submitted
any marketing applications for any of its product candidates.
New drug marketing applications must include extensive preclinical
and clinical data and supporting information to establish the product candidate's safety and effectiveness for each desired indication. Such marketing applications must also include significant information regarding the chemistry,
manufacturing, and controls for the product. Even if Angion resumes clinical trials of its product candidates, obtaining approval of its product candidates will be a lengthy, expensive, and uncertain process, and it may not be successful.
Specifically, the review processes of the FDA and foreign regulatory authorities can take years to complete, and approval is never guaranteed. Even if a product is approved, the FDA or foreign regulatory authorities may limit the indications
for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming additional clinical trials or reporting as conditions of approval. The FDA or foreign regulatory authorities also
may not approve Angion’s product candidates with the labeling it believes is necessary or desirable for the successful commercialization of its product candidates. Obtaining regulatory approval for marketing of a product candidate in one
country does not ensure Angion will be able to obtain regulatory approval in any other country.
If Angion resumes clinical trials, it cannot predict whether the
clinical trials of its product candidates will be successful, or whether regulators will agree with its conclusions regarding the preclinical studies and clinical trials Angion has conducted to date or it conducts in the future. If Angion is
unable to obtain approval from regulatory authorities for any of its product candidates, Angion may not be able to generate sufficient revenue to become profitable or to continue its operations.
Delays or difficulties in the commencement,
enrollment and completion of clinical trials could result in increased costs to Angion and delay or limit Angion’s ability to obtain regulatory approval its product candidates.
If Angion resumes or commences clinical trials, delays in the
commencement, enrollment, and completion of clinical trials would increase its product development costs beyond what it expects or could limit the regulatory approval of its product candidates. Delays in any of Angion’s clinical trials may
increase the amount of additional funding Angion will require to complete these trials.
Changes in regulatory requirements and related guidance related to
regulatory approval may also occur and Angion may need to amend clinical trial protocols to reflect these changes. Amendments may require Angion to resubmit clinical trial protocols to Institutional Review Boards (IRB) for re-examination, which
may impact the costs, timing or successful completion of its clinical trials.
Furthermore, if Angion is required to conduct additional clinical
trials or other preclinical studies of Angion’s product candidates beyond those it contemplates, its ability to obtain or maintain regulatory approval of these product candidates and generate revenue from their sales would be similarly harmed.
Clinical failure can occur at any stage of
clinical development, and the results of earlier clinical trials are not necessarily predictive of future results.
Clinical failure can occur at any stage of Angion’s clinical
development. For example, in the fourth quarter of 2021, Angion disclosed the results of the ANG-3777 Phase 3 clinical trial for delayed graft function (DGF) and AKI associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI),
neither of which met their primary endpoints despite the existence of encouraging preclinical and clinical data for ANG-3777 established prior to initiating such studies. Clinical trials may produce negative or inconclusive results, and Angion
or its collaborators may decide, or regulators may require Angion, to conduct additional clinical trials or preclinical studies. In addition, data obtained from trials and studies are susceptible to various interpretations, and regulators may
not interpret Angion’s data as favorably as Angion does, which may delay, limit or prevent regulatory approval. Success in
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preclinical studies and early clinical trials does not ensure subsequent clinical
trials will generate the same or similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. A number of companies in the pharmaceutical industry, including those with greater resources and
experience than Angion, have suffered significant setbacks in Phase 3 registration trials, even after seeing promising results in earlier clinical trials or preclinical studies.
In addition, the design of a clinical trial can determine whether
its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. Angion has limited experience in designing clinical trials as it has never previously
completed a Phase 3 registration trial with results sufficient to obtain regulatory approval or submitted an NDA to the FDA or a marketing application to any foreign regulatory authority, and it may be unable to design and execute a clinical
trial to support regulatory approval. Further, clinical trials of potential products often reveal it is not practical or feasible to continue development efforts, as has occurred with the clinical development of ANG-3070.
If Angion resumes or commence clinical trials, the product
candidates in those clinical trials may be the subject of clinical trial failures or found to be unsafe or lack efficacy, and if that were to occur Angion would not be able to obtain regulatory approval for them and its business would be
harmed.
Angion’s product candidates may have
undesirable side effects which may delay or halt clinical development or prevent marketing approval or, if approval is received, require them to be taken off the market, require them to include safety warnings, or otherwise limit their sales.
The results of any clinical trials of Angion’s product candidates
may show such product candidates led to patient safety concerns or undesirable or unacceptable side effects, creating risk to the patient which is deemed to outweigh the potential benefits of treatment to that patient. Unforeseen side effects
from any of Angion’s product candidates could arise either during clinical development or, if approved, after the approved product has been marketed. Any such event could interrupt, delay or halt such clinical trials, resulting in the denial of
regulatory approval by the FDA and other regulatory authorities or result in restrictive label warnings, if approved. In light of widely publicized events concerning the safety risk of certain drug products, regulatory authorities, members of
Congress, the Government Accounting Office, medical professionals and the general public have raised concerns about potential drug safety issues. These events have resulted in the withdrawal of drug products, revisions to drug labeling that
further limit use of the drug products and establishment of risk management programs that may, for instance, restrict distribution of drug products. The increased attention to drug safety issues may result in a more cautious approach by the FDA
to clinical trials. Data from clinical trials may receive greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to terminate clinical trials before completion, or require longer or
additional clinical trials that may result in substantial additional expense and a delay or failure in obtaining approval or approval for a more limited indication than originally sought.
Angion has relied, and may continue to rely,
on single-source third party contract manufacturing organizations to manufacture and supply Angion’s product candidates, and if the FDA or foreign regulatory authorities do not approve these manufacturing facilities or if these organizations
fail to perform, Angion’s ability to conduct clinical trials and obtain regulatory approval for its product candidates may be harmed.
Angion does not own facilities for clinical and commercial
manufacturing of its product candidates, and to the extent it resumes or commences clinical trials of any of its product candidates, it will rely upon third-party contract manufacturing organizations to manufacture and supply product candidates
for its clinical trials and will rely on such manufacturers to meet commercial demand.
Additionally, the facilities at which any of Angion’s product
candidates are manufactured must be the subject of a satisfactory inspection before the FDA or the regulators in other jurisdictions approve the product candidate manufactured at that facility. Angion is completely dependent third-party vendors
for compliance with the current Good Manufacturing Practice requirements (cGMP), and the requirements of United States and non-United States regulators for the manufacture of Angion’s active ingredients, drug products, and finished products. If
Angion’s manufacturers cannot successfully manufacture material conforming to Angion’s specifications and cGMP of any applicable governmental agency, Angion’s product candidates will not be approved or, if already approved, may be subject to
recalls or demands by regulatory agencies to stop selling the product until manufacturing issues are resolved.
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If Angion is able to develop and obtain
regulatory approval for any of its product candidates, its business will be materially harmed if it is unable to successfully commercialize such approved products.
Even if Angion pursues and receives regulatory approval of any
product candidate, it is uncertain whether Angion will be able to successfully commercialize such product. Angion’s marketing of any approved product will be limited to the product’s approved use and potentially subject to other limitations as
set forth in its approved prescribing information and package insert. Accordingly, Angion cannot ensure any of its future approved products will be successfully developed, approved or commercialized. If Angion is unable to successfully
commercialize any future approved products, Angion may not be able to generate sufficient revenue to operate its business.
Risks Relating to Angion’s Business
Angion faces competition from other
biotechnology and pharmaceutical companies and its operating results will suffer if Angion fails to compete effectively.
The biotechnology and pharmaceutical industries are intensely
competitive and subject to rapid and significant technological change. Angion will have competitors in the United States, Europe, and other jurisdictions, including major multinational pharmaceutical companies, established biotechnology
companies, specialty pharmaceutical and generic drug companies, and universities and other research institutions, for any of Angion’s product candidates it determines to pursue. Many of these competitors have greater financial and other
resources, such as larger research and development staff and more experienced marketing and manufacturing organizations. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory
approvals, recruiting patients, and manufacturing pharmaceutical products. These companies also have significantly greater research, sales, and marketing capabilities and collaborative arrangements in Angion’s target markets with leading
companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds potentially making the product candidates Angion
develops obsolete. As a result of all of these factors, any of these competitors may succeed in obtaining patent protection and/or FDA approval or discovering, developing, and commercializing drugs for kidney, heart, liver, lung and other
diseases Angion is targeting before Angion does. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. In addition, many universities
and private and public research institutes may become active in Angion’s target disease areas.
Angion will depend on single third-party
suppliers for the manufacture and supply of drug substance and potential future commercial product supplies for its product candidates, and any performance failure on the part of its supplier could delay the development and potential
commercialization of its product candidates.
To the extent Angion resumes or commences clinical trials of its
product candidates, Angion cannot be certain its drug substance supplier will continue to provide it with sufficient quantities of drug substance, or its manufacturers will be able to produce sufficient quantities of drug product incorporating
such drug substance, to satisfy its anticipated specifications and quality requirements, or such quantities can be obtained at pricing necessary to sustain acceptable pharmaceutical margins for any of its product candidates, if approved.
Angion’s dependence on a single supplier for its drug substance and the challenges it may face in obtaining adequate supply of drug substance involves several risks, including limited control over pricing, availability, quality and delivery
schedules, and such risks may be heightened as a result of the COVID-19 pandemic. Any supply interruption in drug substance or drug product could materially harm Angion’s ability to complete its development program for such indications, until a
new source of supply, if any, could be identified and qualified. Angion may be unable to find a sufficient alternative supply channel in a reasonable time or on commercially reasonable terms. Any performance failure on the part of Angion’s
suppliers could delay the development and potential commercialization of Angion’s product candidates, including limiting supplies necessary for clinical trials and regulatory approvals, which would have a material adverse effect on Angion’s
business.
Angion faces potential product liability
exposure, and if successful claims are brought against it, Angion may incur substantial liability for a product candidate and may have to limit its commercialization.
The use of Angion’s product candidates in clinical trials and the
sale of any products for which Angion may obtain marketing approval exposes it to the risk of product liability claims. Product liability claims may be brought against Angion or its collaborators by participants enrolled in Angion’s past and
any future clinical trials, patients, healthcare providers, or others using, administering, or selling Angion’s products. If Angion cannot successfully defend itself against any such claims, it would incur substantial liabilities.
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Under the terms of the government grant
funding Angion has received, the government may compel Angion to license to a third party, or suspend, terminate or withhold grant funding.
A significant amount of Angion’s discovery and initial clinical
research it has conducted has been funded principally by United States government grants and contracts. As with all other pharmaceutical research programs supported in part by federal research dollars, conducting research under federal grants
required Angion to grant the U.S. government a nonexclusive, nontransferable, irrevocable, paid-up license for the government to practice or have the invention practiced on its behalf throughout the world. Under certain circumstances, the
government can require the grantee to license a third party, or the government may take title and grant a license itself, known as march-in rights, which may occur if the invention is not brought to practical use within a reasonable time, if
health or safety issues arise, if public use of the invention is in jeopardy, or if other legal requirements are not satisfied. Although, to Angion’s knowledge, the U.S. government has never forced a grantee to license a third party or taken
title and granted a license itself, these march-in rights are available to the government, and Angion cannot assure you the government will not exercise such rights in the future.
Under the terms and conditions of the government grant funding,
Angion is obligated to comply with various reporting requirements and to take certain administrative actions. Material noncompliance with the terms and conditions of the grant funding may result in one or more enforcement actions by the grant
agency. These enforcement actions include denying funds for the cost of funded activities, suspending the grant in whole or in part, pending corrective action, and withholding further grant awards. The grant agency may also terminate the grant
for cause, or take other legally available remedies.
Risks Relating to Angion’s Intellectual Property
It is difficult and costly to protect
Angion’s proprietary rights, and Angion may not be able to ensure their protection. If Angion’s patent position and potential regulatory exclusivity do not adequately protect Angion’s product candidates, others could compete against Angion more
directly, which would harm Angion’s business, possibly materially.
Angion’s success will depend in part on obtaining and maintaining
patent protection and trade secret protection of its current and future product candidates, and their methods of manufacture and use. Angion’s ability to stop third parties from making, using, selling, offering to sell or importing its product
candidates is dependent upon the extent to which it has rights under valid and enforceable patents and/or trade secrets that cover these activities. The patent positions of biotechnology and pharmaceutical companies can be highly uncertain and
involve complex legal and factual questions. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the United States or in many jurisdictions outside of the United States. Changes in
either the patent laws or interpretations of patent laws in the United States and other countries may diminish the value of Angion’s intellectual property. Accordingly, Angion cannot predict the breadth of claims that may be issued in relevant
jurisdictions from its present or future patent filings, or those it licenses from third parties, and further cannot predict the extent to which it will be able to enforce such issued claims in jurisdictions important to its business. If any
patents Angion obtains or licenses are deemed invalid and unenforceable, Angion’s ability to commercialize or license its technology could be adversely affected.
It is possible others have filed, and in the future may file,
patent applications covering products and technologies similar, identical or competitive to ours, or are otherwise important to Angion’s business. Angion cannot be certain any patent filings owned by a third party will not have priority over
patent applications filed or in-licensed by it, or it or its licensors will not be involved in interference, opposition or invalidity proceedings before United States or foreign patent offices. The costs of defending Angion’s patents or
enforcing Angion’s proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse determination in any such submission, proceeding or litigation could reduce the
scope of, or invalidate, Angion’s patent rights, and/or could allow third parties to commercialize Angion’s technology or products and compete directly with Angion, without payment to Angion. Furthermore, third-party filings may issue as
patents infringed by Angion’s manufacture or commercialization of Angion’s products. Licenses may not be available to such third-party patents, and challenges to their validity or infringement may be expensive and may not succeed. If the
breadth or strength of protection provided by Angion’s patents and patent applications is threatened, or if Angion is perceived or found to infringe intellectual property rights of others, it could dissuade companies from collaborating with
Angion to license, develop or commercialize current or future product candidates, and could impede or preclude Angion’s ability to commercialize its products.
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The issuance of a patent is not conclusive as to its
inventorship, scope, validity or enforceability, and Angion’s owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Angion may become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging its patent rights or the patent rights of others. Such challenges may result in loss of exclusivity or in patent claims being
narrowed, invalidated or held unenforceable, in whole or in part, any of which could limit Angion’s ability to stop others from using or commercializing similar or identical technology and products, and/or limit the duration of the patent
protection of Angion’s technology and products.
Without patent protection for Angion’s compounds, pharmaceutical
compositions, or formulations of Angion’s product candidates, Angion’s ability to stop others from using or selling its products, or other competitive products including its compounds, may be limited.
If the patent applications Angion holds or has in-licensed with
respect to present or future product candidates fail to issue, if their breadth and/or strength of protection is limited or challenged, or if they fail to provide meaningful exclusivity for present or future product candidates, it could
dissuade companies from collaborating with Angion to develop future candidates and threaten Angion’s ability to commercialize future commercial products. Any such outcome could have a materially adverse effect on Angion’s business.
Angion may incur substantial costs as a
result of litigation or other proceedings relating to patent and other intellectual property rights.
If Angion chooses to go to court to stop another party from using
the inventions claimed in any patents it obtains, that individual or company has the right to ask the court to rule such patents are invalid or should not be enforced against that third party. These lawsuits are expensive, would consume time
and resources and would divert the attention of managerial and scientific personnel even if Angion were successful in stopping the infringement of such patents. In addition, there is a risk the court will decide such patents are not valid and
Angion does not have the right to stop the other party from using the inventions.
There is also a risk, even if the validity of such patents is
upheld, the court will refuse to stop the other party on the grounds such other party's activities do not infringe Angion’s patents. In addition, the United States Supreme Court has recently modified some tests used by the USPTO in granting
patents over the past 20 years, which may decrease the likelihood Angion will be able to obtain patents and increase the likelihood of challenge of any patents Angion obtains or licenses.
Angion may infringe the intellectual
property rights of others, which may prevent or delay its product development efforts and stop it from commercializing, or increase the costs of commercializing, its product candidates.
Angion’s success will depend in part on Angion’s ability to
operate without infringing the proprietary rights of third parties. Angion cannot guarantee its products or product candidates, or their manufacture or use, will not infringe third-party patents. Furthermore, a third party may claim Angion or
its manufacturing or commercialization collaborators are using inventions covered by the third party's patent rights. It is also possible a third party might allege Angion’s products or product candidates, or their manufacture or use,
incorporate or rely on trade secrets improperly received from the third party. A third-party alleging violations of their intellectual property rights may go to court to stop Angion from engaging in Angion’s normal operations and activities,
including making or selling Angion’s candidates. Defense of such claims, regardless of their merit, are costly and could affect Angion’s results of operations and divert the attention of managerial and scientific personnel.
There is a risk a court would decide Angion or its
commercialization collaborators are infringing the third party's intellectual property rights and would order Angion or its collaborators to stop relevant activities. In that event, Angion or its commercialization collaborators may not have a
viable way to avoid the infringement and may need to halt commercialization of the relevant product. In addition, there is a risk a court will order Angion or its collaborators to pay the other party damages for having infringed the other
party's intellectual property rights. In the future, Angion may agree to indemnify its commercial collaborators against certain intellectual property infringement claims brought by third parties. The pharmaceutical and biotechnology industries
have produced a proliferation of patents, and it is not always clear to industry participants, including Angion, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the
courts, and the interpretation is not always uniform.
If Angion is sued for patent or other intellectual property (e.g.,
trade secret, trademark, etc.) infringement, it could incur significant costs, and delays in its product development or commercialization.
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Angion’s competitors may have filed, and may in the future
file, patent applications covering technology like ours. Any such patent application may have priority over Angion’s patent applications, which could further require Angion to obtain rights to issued patents covering such technologies. If
another party has filed a United States patent application on inventions similar to ours, Angion may have to participate in an interference or derivation proceeding declared by the USPTO to determine priority of invention in the United States.
The costs of these proceedings could be substantial, and it is possible such efforts would be unsuccessful if, unbeknownst to Angion, the other party had independently arrived at the same or similar invention prior to Angion’s own invention,
resulting in a loss of Angion’s United States patent position with respect to such inventions, and granting such position to the third party, so Angion may need to seek a license from such third party to continue its use of the technologies,
which license might not be available, or might impose significant costs.
Other countries have similar laws permitting secrecy of patent
applications and may be entitled to priority over Angion’s applications in such jurisdictions.
In addition, Angion may be subject to claims that it is infringing
other intellectual property rights, such as trademarks or copyrights, or misappropriating the trade secrets of others, and to the extent its employees, consultants or contractors use intellectual property or proprietary information owned by
others in their work for Angion, disputes may arise as to the rights in related or resulting know-how and inventions.
Angion may not have sufficient resources to bring actions alleging
intellectual property infringement to a successful conclusion. In addition, if Angion does not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared
invalid, it may incur substantial monetary damages, encounter significant delays in bringing its product candidates to market and be precluded from manufacturing or selling its product candidates. Furthermore, even if Angion is successful in
proceedings relating to alleged intellectual property infringement or misappropriation, it may incur substantial costs and divert management's time and attention in pursuing these proceedings, which could have a material adverse effect on
Angion.
Some of Angion’s competitors may be able to sustain the costs of
complex litigation more effectively than Angion can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on
Angion’s ability to raise the funds necessary to continue its operations.
Obtaining and maintaining Angion’s patent
protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and Angion’s patent protection could be reduced or eliminated for non-compliance with
these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various
other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. Angion has
systems in place to remind it to pay these fees, and it employs an outside firm and relies on its outside counsel to pay these fees due to the USPTO and non-United States patent agencies. The USPTO and various foreign governmental patent
agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. Angion employs reputable law firms and other professionals to help it comply, and in many
cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, Angion’s competitors might be able to enter the market and this circumstance could have a material adverse effect on Angion’s
business.
The laws of some foreign countries do not
protect proprietary rights to the same extent as do the laws of the United States, and Angion may encounter significant problems in securing and defending its intellectual property rights outside the United States.
Many companies have encountered significant problems in protecting
and defending intellectual property rights in certain countries. The legal systems of certain countries, particularly certain developing countries, do not always favor the enforcement of patents, trade secrets, and other intellectual property
rights, particularly those relating to pharmaceutical products, which could make it difficult for Angion to stop infringement of its patents, misappropriation of its trade secrets, or marketing of competing products in violation of its
proprietary rights.
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Proceedings to enforce Angion’s intellectual property rights in foreign countries
could result in substantial costs, divert Angion’s efforts and attention from other aspects of its business, and put Angion’s patents in these territories at risk of being invalidated or interpreted narrowly, or Angion’s patent applications at
risk of not being granted, and could provoke third parties to assert claims against Angion. Angion may not prevail in all legal or other proceedings it may initiate and, if Angion were to prevail, the damages or other remedies awarded, if any,
may not be commercially meaningful. Accordingly, Angion’s efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property it develops or
licenses.
Risks Relating to Angion Common Stock
Angion’s stock price may be volatile and you
may not be able to resell shares of Angion common stock at or above the price you paid.
The trading price of Angion common stock could be highly volatile
and could be subject to wide fluctuations in response to various factors, some of which are beyond Angion’s control. These factors include those discussed above.
In addition, the stock markets in general, and the markets for
pharmaceutical and biotechnology stocks in particular, have experienced extreme volatility that may have been unrelated to the operating performance of the issuer. These broad market fluctuations may adversely affect the trading price or
liquidity of Angion common stock. In the past, when the market price of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation against the issuer. If Angion were to become involved in
securities litigation, it could incur substantial costs and resources and the attention of Angion’s management could be diverted from the operation of Angion’s business.
Angion is an “emerging growth company” and
as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, Angion common stock may be less attractive to investors.
Angion is an “emerging growth company,” as defined in Jumpstart
Our Business Act of 2012, (JOBS Act), and Angion intends to continue taking advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies including, but not
limited to, not being required to comply with the auditor attestation requirements of Section 404, reduced disclosure obligations regarding executive compensation in Angion’s periodic reports and proxy statements, and exemptions from the
requirements of holding a nonbinding advisory vote on executive compensation and obtaining stockholder approval of any golden parachute payments not previously approved. In addition, as an “emerging growth company,” the JOBS Act allows Angion
to delay adoption of new or revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. Angion has elected to use this extended transition period under the JOBS Act. As a
result, Angion’s financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards applicable to public companies, which may make
comparison of Angion’s financials to those of other public companies more difficult. Even after Angion no longer qualifies as an emerging growth company, it may still qualify as a “smaller reporting company” which would allow it to take
advantage of many of the same exemptions from disclosure requirements including not being required to comply for a period of time with the auditor attestation requirements of Section 404, and reduced disclosure obligations regarding executive
compensation in this report and Angion’s periodic reports and proxy statements.
Angion cannot predict if investors will find Angion common stock
less attractive because Angion will rely on these exemptions. If some investors find Angion common stock less attractive as a result, there may be a less active trading market for Angion common stock and Angion’s stock price may be more
volatile. Angion may take advantage of these reporting exemptions until it is no longer an emerging growth company or smaller reporting company.
Angion has completed and may in the future
complete related party transactions that were not and may not be conducted on an arm's length basis.
Angion has in the past and continues to be party to certain
transactions with certain entities affiliated with Dr. Goldberg, director and Chairman Emeritus on the Angion Board, as well as certain of his immediate family members. For instance, in November 2013, Angion granted Ohr Cosmetics, LLC (Ohr), an
affiliated company, an exclusive worldwide license, with the right to sublicense, under Angion’s patent rights covering Angion’s CYP26 inhibitors, including ANG-3522, for the use in treating conditions of the skin or hair. Angion owns, and the
family
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of Dr. Goldberg owns, approximately 2.4% and 78.7%, respectively, of the
membership interests in Ohr. Dr. Goldberg's son is the manager of Ohr. In addition, Dr. Venkatesan, Angion's President and Chief Executive Officer and director, and Mr. Ganzi, Angion's lead independent director, each own approximately 1.6% of
the membership interests in Ohr.
In addition, prior to March 2023, Angion rented office and
laboratory space in Uniondale, New York from NovaPark LLC (NovaPark), an affiliated company, under a lease that was scheduled to expire on June 20, 2026. The space Angion rents is part of an approximately 110,000-square-foot general laboratory
and development facility (NovaPark Facility) for biological and chemistry research owned by NovaPark. In March 2023, Angion entered into a Surrender Agreement with NovaPark which terminated the Uniondale, New York lease for a termination fee of
$3.03 million and entered into a Membership Interest Redemption Agreement with NovaPark to relinquish its 10% membership interest in NovaPark. Prior to entering into the Membership Interest Redemption Agreement, Angion owned, and Dr. Goldberg
and Rina Kurz, Dr. Goldberg's spouse, owned 10%, 45% and 45%, respectively, of the membership interests in NovaPark.
Provisions in Angion’s charter documents
and under Delaware law could discourage a takeover stockholders may consider favorable and may lead to entrenchment of management.
Angion’s amended and restated certificate of incorporation and
amended and restated bylaws contain provisions that could delay or prevent changes in control or changes in Angion’s management without the consent of the Angion Board. These provisions include the following:
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a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the
membership of a majority of the Angion Board;
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no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director
candidates;
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the exclusive right of the Angion Board to elect a director to fill a vacancy created by the expansion of the Angion Board or
the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on the Angion Board;
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the ability of the Angion Board to authorize the issuance of shares of preferred stock and to determine the price and other
terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;
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the ability of the Angion Board to alter Angion’s amended and restated bylaws without obtaining stockholder approval;
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the required approval of at least 66 2/3% of the shares entitled to vote at an election of directors to adopt, amend or
repeal Angion’s amended and restated bylaws or repeal the provisions of Angion’s amended and restated certificate of incorporation regarding the election and removal of directors;
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a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special
meeting of Angion’s stockholders;
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the requirement that a special meeting of stockholders may be called only by Angion’s chief executive officer or president or
chairperson of the Angion Board or by the Angion Board directors, which may delay the ability of Angion’s stockholders to force consideration of a proposal or to take action, including the removal of directors; and
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advance notice procedures stockholders must comply with in order to nominate candidates to the Angion Board or to propose
matters to be acted upon at a stockholders' meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror's own slate of directors or otherwise attempting to obtain control
of Angion.
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Angion is also subject to the anti-takeover provisions contained
in Section 203 of the DGCL. Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other
exceptions, the Angion Board has approved the transaction.
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Angion’s amended and restated certificate
of incorporation and amended and restated bylaws provide for an exclusive forum in the Court of Chancery of the State of Delaware for certain disputes between Angion and its stockholders, which could limit Angion’s stockholders’ ability to
obtain a favorable judicial forum for disputes with Angion or its directors, officers or employees.
Angion’s amended and restated certificate of incorporation and
amended and restated bylaws provide that the Court of Chancery of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware or other state courts of
the State of Delaware) is the exclusive forum for any derivative action or proceeding brought on Angion’s behalf, any action asserting a claim of breach of fiduciary duty, any action asserting a claim against Angion arising pursuant to the
DGCL, Angion’s amended and restated certificate of incorporation or Angion’s amended and restated bylaws, or any action asserting a claim against Angion that is governed by the internal affairs doctrine; provided that, the exclusive forum
provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery
of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware. Angion’s amended and restated certificate of
incorporation and amended and restated bylaws also provide the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action against Angion or any of its
directors, officers, employees or agents and arising under the Securities Act. Nothing in Angion’s amended and restated certificate of incorporation or amended and restated bylaws precludes stockholders that assert claims under the Exchange Act
from bringing such claims in state or federal court, subject to applicable law.
Angion believe these provisions may benefit it by providing
increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable, particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited
schedule relative to other forums and protection against the burdens of multi-forum litigation. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with
Angion or any of its directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims, although Angion’s stockholders will not be deemed to have waived Angion’s compliance with federal securities
laws and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible a court could
find these types of provisions to be inapplicable or unenforceable. While the Delaware courts have determined such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those
designated in the exclusive-forum provisions, and there can be no assurance such provisions will be enforced by a court in those other jurisdictions. If a court were to find the choice of forum provision contained in Angion’s amended and
restated certificate of incorporation and amended and restated bylaws to be inapplicable or unenforceable in an action, Angion may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect
its business and financial condition.
Security breaches, cyber-attacks or other
disruptions or incidents could expose Angion to liability and affect its business and reputation.
Angion is increasingly dependent on its information technology
systems and infrastructure for its business. Angion, its collaborators and its service providers collect, store, and transmit sensitive information including intellectual property, proprietary business information, clinical trial data and
personal information in connection with Angion’s business operations. The secure maintenance of this information is critical to Angion’s operations and business strategy. Some of this information could be an attractive target of criminal attack
by third parties with a wide range of motives and expertise, including organized criminal groups, “hacktivists,” patient groups, disgruntled current or former employees, nation-state and nation-state supported actors and others. Cyber-attacks
are of ever-increasing levels of sophistication, and despite Angion’s security measures, its information technology and infrastructure may be vulnerable to such attacks or may be breached, including due to employee error or malfeasance. Angion
has implemented information security measures to protect its systems, proprietary information and sensitive data, including the personal information of clinical trial participants against the risk of inappropriate and unauthorized external use
and disclosure and other types of compromise. However, despite these measures, and due to the ever-changing information cyber-threat landscape, Angion cannot guarantee these measures will be adequate to detect, prevent or mitigate security
breaches and other incidents and Angion may be subject to data breaches through cyber-attacks, malicious code (such as viruses and worms), phishing attacks, social engineering schemes, and insider theft or misuse. Any such breach could
compromise Angion’s networks and the information stored there could be
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accessed, modified, destroyed, publicly disclosed, lost or stolen. If Angion’s
systems become compromised, Angion may not promptly discover the intrusion. Like other companies in Angion’s industry, Angion has experienced attacks to its data and systems, including malware and computer viruses. Any security breach or other
incident, whether real or perceived, would cause Angion to lose product sales, if any, and suffer reputational damage and loss of customer confidence. Such incidents could result in costs to respond to, investigate and remedy such incidents,
notification obligations to affected individuals, government agencies, credit reporting agencies and other third parties, legal claims or proceedings, and liability under Angion’s contracts with other parties and federal and state laws that
protect the privacy and security of personal information. If a security breach, cyber-attack, or other disruption is the result of state-sponsored activities, it may be considered an “act-of-war”, potentially making Angion ineligible for
reimbursement under its insurance policies covering such attacks. Any one of these events could cause Angion’s business to be materially harmed and its results of operations would be adversely impacted.
Elicio has a history of operating losses that
are expected to continue for the foreseeable future, and it is unable to predict the extent of future losses, or whether it will generate significant revenues or achieve or sustain profitability.
Elicio has focused on product development and has not generated
any revenues to date. Additionally, it expects to continue to incur operating losses for the foreseeable future. These operating losses have adversely affected and are likely to continue to adversely affect Elicio’s working capital, total
assets and stockholders’ deficit.
Since Elicio is an early-stage company, its prospects must be
considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. Specifically, it has generated operating losses each year since its inception, including $28.2
million and $26.4 million for the years ended December 31, 2022 and 2021, respectively. Elicio expects to make substantial expenditures and incur increasing operating costs in the future and its accumulated deficit will increase significantly
as it expands development and clinical trial activities for its product candidates. Because of the risks and uncertainties associated with product development, Elicio is unable to predict the extent of any future losses, whether it will ever
generate significant revenues or if it will ever achieve or sustain profitability.
Elicio believes that its cash on hand, along with the minimum cash
of $25 million required to be delivered by Angion in the Merger, will enable it to fund its operations through calendar year 2023 based on its current plan. Elicio is dependent on obtaining, and is continuing to pursue, necessary funding from
outside sources, including obtaining additional funding from the issuance of securities in order to continue its operations. Without adequate funding, it may not be able to meet its financial obligations.
Elicio has not demonstrated an ability to perform the functions
necessary for the successful commercialization of any products. The successful commercialization of any of its products will require it to perform a variety of functions, including:
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continuing to undertake preclinical and clinical development;
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engaging in the development of product candidate formulations and manufacturing processes;
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interacting with the applicable regulatory authorities and pursuing other required steps for regulatory approval;
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engaging with payors and other pricing and reimbursement authorities;
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submitting marketing applications to and receiving approval from the applicable regulatory authorities; and
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manufacturing the applicable products and product candidates in accordance with regulatory requirements and, if ultimately
approved, conducting sales and marketing activities in accordance with health care, FDA and similar foreign regulatory authority laws and regulations.
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Elicio has a limited operating history and
it expects a number of factors to cause its operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict its future performance.
Elicio is a clinical stage biopharmaceutical company with a
limited operating history. Its operations to date have been primarily limited to organizing and staffing its company, acquiring, developing and securing its proprietary technology and preclinical and clinical development of its product
candidates. It has not yet successfully completed
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any clinical trials for any of its product candidates, manufactured its product
candidates at commercial scale or conducted sales and marketing activities that will be necessary to successfully commercialize its product candidates, if approved. Consequently, any predictions made about its future success or viability may
not be as accurate as they could be if it had a longer operating history or commercialized products. Elicio’s financial condition has varied significantly in the past and will continue to fluctuate from quarter-to-quarter or year-to-year due to
a variety of factors, many of which are beyond its control. Factors relating to its business that may contribute to these fluctuations include other factors described elsewhere in this proxy statement/prospectus/information statement and also
include, among other things:
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Elicio’s ability to obtain additional funding to develop its product candidates;
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Elicio’s ability to conduct and complete nonclinical studies and clinical trials,
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delays in the commencement, enrollment and timing of clinical trials;
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the success of Elicio’s nonclinical studies and clinical trials through all phases of development;
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any delays in regulatory review and approval of product candidates in clinical development;
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Elicio’s ability to obtain and maintain regulatory approval for its product candidates in the United States and foreign
jurisdictions;
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potential toxicity and/or side effects of Elicio’s product candidates that could delay or prevent commercialization, limit
the indications for any approved products, require the establishment of risk evaluation and mitigation strategies, or cause an approved drug to be taken off the market;
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Elicio’s ability to establish or maintain partnerships, collaborations, licensing or other arrangements;
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market acceptance of Elicio’s product candidates, if approved;
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competition from existing products, new products or new therapeutic approaches that may emerge;
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the ability of patients or health care providers to obtain coverage of or sufficient reimbursement for Elicio’s products;
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Elicio’s ability to leverage its proprietary AMP technology platform to discover and develop additional product candidates;
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Elicio’s ability and its licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property
rights important to its business; and
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potential product liability claims.
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Accordingly, the results of any quarterly or annual periods should
not be relied upon as indications of future operating performance.
Elicio will require substantial additional
capital to finance its operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force it to delay, limit, reduce or terminate its research and development programs, commercialization efforts
or cease operations.
Elicio’s operations have consumed substantial amounts of cash.
During the years ended December 31, 2022 and 2021, it incurred research and development expenses of $18.1 million and $17.9 million, respectively. Elicio will require substantial additional funds to support its continued research and
development activities, including the anticipated costs of nonclinical studies and clinical trials, regulatory approvals and potential commercialization. Additionally, its estimates on future financial needs may be based on assumptions that
prove to be wrong, and it may spend its available financial resources much faster than it expects.
Until such time, if ever, that Elicio can generate sufficient
product revenue and achieve profitability, it expects to seek to finance future cash needs through equity or debt financings and/or corporate collaboration, licensing arrangements and grants. It currently has no other commitments or agreements
relating to any of these types of transactions and cannot be certain that additional funding will be available to it on acceptable terms, or at all. Furthermore, the ongoing impact of COVID-19 and geopolitical instability, including the recent
military conflict between Russia and Ukraine, as well as the impact of inflationary pressures and resulting rise in interest rates, on
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global financial markets could make the terms of any available financing less
attractive to Elicio and more dilutive to its existing stockholders. If it is unable to raise additional capital, it will have to delay, curtail or eliminate one or more of its research and development programs or cease operations.
Additionally, raising additional capital may cause dilution to its stockholders.
Elicio has never generated revenue from product
sales and may never become profitable.
Elicio’s ability to generate product sales and achieve
profitability depends on its ability, alone or with collaborative partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize its current and future product candidates. It does not
anticipate generating product sales for the next several years, if ever.
Elicio’s product candidates will require additional clinical,
manufacturing, and non-clinical development, regulatory approval, commercial manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before it generates any product sales. It
cannot guarantee that it will meet its timelines for its development programs, which may be delayed or not completed for a number of reasons. Elicio’s ability to generate future revenues from product sales depends heavily on its, or its
collaborators’, ability to successfully:
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complete research and obtain favorable results from nonclinical and clinical development of Elicio’s current and future
product candidates, including addressing any clinical holds that may be placed on its development activities by regulatory authorities;
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seek and obtain regulatory and marketing approvals for any of Elicio’s product candidates for which it completes clinical
trials, as well as their manufacturing facilities;
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launch and commercialize any of Elicio’s product candidates for which it obtains regulatory and marketing approval by
establishing a sales force, marketing, and distribution infrastructure or, alternatively, collaborating with a commercialization partner;
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qualify for coverage and establish adequate reimbursement by government and third-party payors for any of Elicio’s product
candidates for which it obtains regulatory and marketing approval;
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develop, maintain, and enhance a sustainable, scalable, reproducible, and transferable manufacturing process for the product
candidates Elicio may develop;
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establish and maintain supply and manufacturing capabilities or capacities internally or with third parties that can provide
adequate, in both amount and quality, products, and services to support clinical development and the market demand for any of Elicio’s product candidates for which it obtains regulatory and marketing approval;
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obtain market acceptance of current or any future product candidates as viable treatment options and effectively compete with
other therapies to establish market share;
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maintain a continued acceptable safety and efficacy profile of Elicio’s product candidates following launch;
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address competing technological and market developments;
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implement internal systems and infrastructure, as needed;
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negotiate favorable terms in any collaboration, licensing, or other arrangements into which Elicio may enter and perform its
obligations in such collaborations;
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maintain, protect, enforce, defend, and expand Elicio’s portfolio of intellectual property rights, including patents, trade
secrets, and know-how;
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avoid and defend against third-party interference, infringement, and other intellectual property claims; and
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attract, hire, and retain qualified personnel.
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Even if one or more of Elicio’s current and future product
candidates are approved for commercial sale, it anticipates incurring significant costs associated with commercializing any approved product candidate. Its expenses could increase beyond its expectations if it is required by the FDA or other
regulatory authorities to perform clinical and other studies in addition to those that it currently anticipates. If it is required to conduct additional clinical trials
40
or other testing of its product candidates that it develops beyond those that it
currently expects, if it is unable to successfully complete clinical trials of its product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive, or if there are safety concerns,
Elicio may be delayed in obtaining marketing approval for its product candidates, not obtain marketing approval at all, or obtain more limited approvals. Even if it is able to generate revenues from the sale of any approved product candidates,
it may not become profitable and may need to obtain additional funding to continue operations.
Even if Elicio does achieve profitability, it may not be able to
sustain or increase profitability on a quarterly or annual basis. Its failure to become and remain profitable would decrease the value of Elicio and could impair its ability to raise capital, maintain its research and development efforts,
expand its business or continue its operations. A decline in the value of Elicio also could cause its stockholders to lose all or part of their investment.
Elicio’s recurring losses from operations
have raised substantial doubt regarding its ability to continue as a going concern.
Elicio’s recurring losses from operations raise substantial doubt
about its ability to continue as a going concern, and as a result, its independent registered public accounting firm included an explanatory paragraph in its report on Elicio’s financial statements as of and for the year ended December 31, 2022
included elsewhere herein with respect to this uncertainty. This going concern opinion could materially limit Elicio’s ability to raise additional funds through the issuance of new debt or equity securities or otherwise. Future reports on its
financial statements may include an explanatory paragraph with respect to its ability to continue as a going concern. Elicio has incurred significant losses since its inception and has never been profitable, and it is possible it will never
achieve profitability. It has devoted a majority of its resources to developing ELI-002 and ELI-004, but these product candidates cannot be marketed until regulatory approvals have been obtained. Meaningful revenues will likely not be available
unless ELI-002, ELI-004, or any of its current or future product candidates are approved by the FDA or comparable regulatory agencies in other countries and successfully marketed, either by Elicio or a partner, an outcome which may not occur.
Elicio believes that its cash on hand, along with the minimum cash of $25 million required to be delivered by Angion in the Merger, will enable it to fund its operations through calendar year 2023 based on its current plan. This period could be
shortened if there are any significant increases in planned or actual spending on development programs or more rapid progress of development programs than anticipated. There is no assurance that financing will be available when needed to allow
it to continue as a going concern. The perception that Elicio may not be able to continue as a going concern may cause others to choose not to do business with it due to concerns about its ability to meet its contractual obligations.
Elicio’s product candidates are at an early
stage of development and may not be successfully developed or commercialized.
Elicio initiated the AMPLIFY-201 trial for ELI-002 in 2021,
targeting KRAS, which product candidate also includes ELI-004, its universal AMP-modified CpG adjuvant and has not previously conducted clinical trials with its product candidates. All of its other product candidates are in preclinical
development and will require substantial further capital expenditures, development, testing, and regulatory approval prior to commercialization. Elicio has limited experience designing clinical trials and has not yet filed or supported a
marketing application. It may be unable to design and execute a clinical trial that ultimately supports marketing approval.
The time required to obtain approval from the FDA and comparable
foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of regulatory authorities. The outcome of studies is also
inherently uncertain. Of the large number of drugs in development, only a small percentage successfully complete the regulatory approval process and are commercialized. The results of nonclinical studies, interim or top-line study results, and
early clinical trials of Elicio’s product candidates may not be predictive of the results of later-stage clinical trials. Failure can occur at any time during the clinical trial process. Product candidates in later stages of clinical trials may
fail to show the desired safety, purity, and potency traits despite having progressed through nonclinical studies and initial clinical trials. Nonclinical and early clinical studies may also reveal unfavorable product candidate characteristics,
including safety concerns. A number of companies have suffered significant setbacks in advanced clinical trials, notwithstanding promising results in earlier trials. In some instances, there can be significant variability in results between
different clinical trials of the same product candidate due to numerous factors, including changes in trial
41
procedures set forth in protocols, differences in the size and type of the patient
populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.
Accordingly, even if Elicio is able to obtain the requisite
financing to fund its development programs, it cannot assure you that its product candidates will be successfully developed or commercialized. Its failure to develop, manufacture or receive regulatory approval for or successfully commercialize
any of its product candidates could result in the failure of its business and a loss of all of its stockholders’ investment.
Elicio’s product candidates are in various
stages of development and it will not be able to commercialize its product candidates if its nonclinical and clinical studies do not produce successful results and/or its clinical trials do not demonstrate the safety and efficacy of its product
candidates; early results and early understanding of product candidate potential may not be predictive of later success. Any product candidates currently in clinical development or that Elicio advances into clinical development are subject to
extensive regulation, which can be costly and time-consuming, and it may experience unanticipated delays or be unable to receive the required approvals to commercialize its product candidates.
Product candidates are susceptible to the risks of failure
inherent at any stage of product development, including the occurrence of unexpected or unacceptable adverse events or the failure to demonstrate efficacy in clinical trials. Clinical development is expensive and can take many years to
complete, and its outcome is inherently uncertain. The results of nonclinical studies, preliminary clinical trial results, and early clinical trials of Elicio’s product candidates may not be predictive of the results of later-stage clinical
trials. Its product candidates may not perform as it expects, may ultimately have a different than expected or no impact at all, may have a different mechanism of action than it initially understands or than it expects in humans, and may not
ultimately prove to be safe or effective.
The nonclinical and clinical development, manufacturing,
packaging, labeling, storage, record-keeping, advertising, promotion, post-approval monitoring and reporting, import, export, marketing and distribution, among other activities, of Elicio’s product candidates are subject to extensive regulation
by the FDA and by comparable health authorities in foreign markets. Elicio is not permitted to market or promote its product candidates in the United States until it receives a Biologics License Application (BLA) from the FDA, or in any
jurisdictions outside of the United States until it receives similar authorization from analogous foreign authorities, and it may never receive such regulatory approvals for any of its product candidates.
Some of Elicio’s product candidates have only been tested in a
nonclinical setting and while those studies have been subject to certain regulatory requirements in order to support product development and regulatory progression, as such product candidates progress they will require clinical trials (which
are subject to much more extensive requirements, including good clinical practice standards), as well as additional manufacturing development, before it will be able to submit marketing applications to the applicable regulatory authorities.
Even if its product candidates are approved, they may be subject to limitations on the indicated uses and populations for which they may be marketed. They may also be subject to other conditions of approval, may contain significant safety
warnings, including boxed warnings, contraindications, and precautions, may not be approved with label statements necessary or desirable for successful commercialization, or may contain requirements for costly post-market testing and
surveillance, or other requirements, including the submission of a risk evaluation and mitigation strategy (REMS) to monitor the safety or efficacy of the products. If Elicio does not receive regulatory authority approval for, and successfully
commercialize its product candidates, it will not be able to generate revenue from these product candidates in the foreseeable future, or at all. Any significant delays in obtaining approval for and commercializing its product candidates could
have a material adverse impact on its business and financial condition.
The process of product candidate development and obtaining
marketing approval is expensive, often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved and the conditions that they are intended to treat. The number and nature of nonclinical
studies and clinical trials that will be required for regulatory approval also varies depending on the product candidate, the disease or condition that the product candidate is designed to address and the regulations applicable to any
particular product candidate. Elicio has not previously submitted a marketing application to the FDA, or a similar marketing application to any comparable foreign authorities, for any product candidate, and it cannot be certain that its product
candidates will be successful in clinical trials or receive regulatory approval.
In addition to significant clinical testing requirements, Elicio’s
ability to obtain marketing approval for its product candidates depends on obtaining the final results of required nonclinical testing, including characterization of the manufactured components of its product candidates and validation of its
manufacturing processes. Regulatory
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authorities may determine that its product manufacturing processes, testing
procedures or facilities are insufficient to justify approval. Approval policies or regulations, or the type and amount of data necessary to gain approval, may change and may vary among jurisdictions. Moreover, regulatory authorities have
substantial discretion in the biopharmaceutical approval process, including the ability to refuse to accept an application and to delay, limit or deny approval of a product candidate for many reasons, such as a determination that Elicio’s data
is insufficient for approval or that additional nonclinical studies, clinical trials or other data or development work is necessary. Despite the time and expense invested in the development of product candidates, regulatory approval is never
guaranteed.
Elicio’s product candidates may fail at any stage of preclinical
or clinical development, and may also reveal unfavorable product candidate characteristics, including safety concerns or the failure to demonstrate efficacy in initial clinical trials. Further, its product candidates may not receive regulatory
approval even if they are successful in clinical trials. Although Elicio has completed preclinical validation, including toxicology testing and clinical supply manufacturing development for ELI-002 and anticipates completing the preclinical
development necessary to file additional INDs for other product candidates in the future, it may experience numerous unforeseen events before, during, or as a result of clinical trials that could delay or prevent its ability to commence or
complete development, commence or complete clinical trials, receive marketing approval or commercialize its product candidates, including:
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Elicio may be unable to generate sufficient nonclinical, toxicology, or other in vivo or in vitro data to support the
initiation of clinical trials;
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regulators or IRBs or Independent Ethics Committees (IECs) may not authorize Elicio or its investigators to commence or
continue a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or may require that it modifies or amends its clinical trial protocols;
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Elicio, regulators, independent data safety monitoring committees, IRBs or IECs, or its data monitoring committee(s) may
recommend or require the suspension or termination of clinical research for various reasons, including non-compliance with regulatory requirements or a finding that participants are being exposed to unacceptable health risks,
undesirable side effects, or a failure of the product candidate to demonstrate any benefit to subjects, or other unexpected characteristics (alone or in combination with other products) of the product candidate, or due to findings of
undesirable effects caused by a chemically or mechanistically similar therapeutic or therapeutic candidate;
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new information may emerge regarding Elicio’s product candidates or technology platform that result in continued development
of some or all of its product candidates being deemed undesirable;
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Elicio may have delays identifying, recruiting and training suitable clinical investigators or investigators may withdraw
from its studies;
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Elicio may experience delays in reaching, or failing to reach, agreement on acceptable clinical trial contracts or clinical
trial protocols with prospective trial sites or contract research organizations (CROs). Contractual terms can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among
different CROs and trial sites;
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Elicio may have delays in adding new investigators or clinical trial sites, or it may experience a withdrawal of clinical
trial sites;
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the number of patients required for clinical trials of Elicio’s product candidates may be larger than it anticipates,
enrollment in these clinical trials may be slower than it anticipates, or participants may drop out of these clinical trials or be lost to follow-up at a higher rate than it anticipates for a number of reasons, such as adverse events,
an inadequate treatment response, fatigue with the clinical trial process or personal issues;
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patients who enroll in Elicio’s studies may misrepresent their eligibility or may otherwise not comply with clinical trial
protocols, resulting in the need to drop those patients from those studies, increase the needed enrollment size for those studies, or extend the duration of those studies;
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there may be flaws in Elicio’s study design, which may not become apparent until a study is well advanced;
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Elicio’s contractors may fail to comply with regulatory requirements or clinical trial protocols, or meet their contractual
obligations to it in a timely manner, or at all, or it may be required to engage in additional clinical trial site monitoring;
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regulatory authorities or IRBs/IECs may disagree with the design, including endpoints, scope, or implementation of Elicio’s
clinical trials, or regulatory authorities may disagree with its intended indications;
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regulatory authorities may disagree with the formulation for Elicio’s product candidates, or its product candidate dose or
dosing schedule;
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Elicio may be unable to demonstrate to the satisfaction of regulatory authorities that a product candidate is safe, pure, and
potent for any indication;
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regulatory authorities may not accept, or Elicio or its clinical trials may not meet the criteria required to submit,
clinical data from trials which are conducted outside of their jurisdictions;
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the results of clinical trials may be negative or inconclusive, may not meet the level of statistical significance required
for, or may not otherwise be sufficient to support marketing approval, and Elicio may decide, or regulatory authorities may require it, to conduct additional clinical trials, analyses, reports, data, or nonclinical studies, or abandon
product development programs;
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Elicio’s product candidates may have undesirable or unintended side effects, toxicities, or other characteristics that
preclude marketing approval or prevent or limit commercial use;
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Elicio may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks or
otherwise provide an advantage over current standard of care (SOC) or current or future competitive therapies in development;
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the standard of care for the indications Elicio is investigating may change, which changes could impact the meaningfulness of
its resulting study data or which may necessitate changes to its studies;
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regulatory authorities may disagree with Elicio’s scope, design, including endpoints, implementation, or its interpretation
of data from nonclinical studies or clinical trials;
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regulatory authorities may require Elicio to amend its studies, perform additional or unanticipated clinical trials or
nonclinical studies or manufacturing development work to obtain approval or initiate clinical trials, or it may decide to do so or abandon product development programs;
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regulatory authorities may find that Elicio or its third-party manufacturers do not satisfy regulatory requirements and
standards for the facilities and operations used in the manufacture of its product candidates;
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the cost of clinical trials of Elicio’s product candidates may be greater than it anticipates, or it may have insufficient
funds for a clinical trial or to pay the substantial user fees required by the FDA or other regulatory authorities upon the filing of a marketing application;
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the supply or quality of Elicio’s product candidates or other materials necessary to conduct clinical trials of its product
candidates may be insufficient or inadequate;
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regulatory authorities may take longer than Elicio anticipates to make a decision on its product candidates; or
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changes in or the enactment of the approval policies, statutes, or regulations of the applicable regulatory authorities may
significantly change in a manner rendering Elicio’s nonclinical or clinical data insufficient for approval.
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Furthermore, Elicio expects to rely on CROs and clinical trial
sites to ensure the proper and timely conduct of its clinical trials and, while it expects to enter into agreements governing their committed activities, it has limited influence over their actual performance.
A clinical trial may be suspended or terminated by Elicio, its
partners, the IRBs of the institutions in which such trials are being conducted, the DSMB for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance
with regulatory requirements or Elicio’s clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or
adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations or administrative actions or lack of
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adequate funding to continue the clinical trial. If Elicio experiences delays in
the completion of, or termination of, any clinical trial of any of its potential future product candidates, the commercial prospects of such product candidate will be harmed, and its ability to generate product revenue from such product
candidates will be delayed. In addition, any delays in completing its clinical trials will increase its costs, slow its product development and approval process and jeopardize its ability to commence product sales and generate revenue, and it
may not have the financial resources to continue development of the product candidate that is affected or any of its other product candidates. It may also lose, or be unable to enter into, collaborative arrangements for the affected product
candidate and for other product candidates that it is developing. Any of these occurrences may materially and adversely affect Elicio’s business, financial condition, results of operations and prospects. In addition, many of the factors that
cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of its potential future product candidates.
Preliminary results from Elicio’s
nonclinical studies and clinical trials that it announces or publishes from time to time may change as more patient data becomes available and as the data undergoes audit and verification procedures.
From time to time, Elicio may publish interim, topline, or
preliminary results from its nonclinical studies and clinical trials. Preliminary and interim results from its clinical trials are not necessarily predictive of final results and are subject to the risk that one or more of the clinical outcomes
may materially change as patient enrollment continues and more patient data become available. Preliminary, interim and topline data also remain subject to audit and verification procedures that may result in the final data being materially
different from the preliminary data it previously published. As a result, preliminary, interim and topline data should be viewed with caution until the final data are available. Material adverse changes in the final data compared to the
preliminary, interim or topline data could significantly harm Elicio’s business prospects.
Further, others, including regulatory agencies, may not accept or
agree with Elicio’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of
the particular product candidate or therapeutic product, if any, and Elicio in general. In addition, the information it chooses to publicly disclose regarding a particular nonclinical study or clinical trial is based on what is typically
extensive information, and you or others may not agree with what it determines is the material or otherwise appropriate information to include in its disclosure, and any information it determines not to disclose may ultimately be deemed
significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular therapeutic product, if any, product candidate or its business. If the preliminary, interim and topline data that it reports differ
from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, its ability to obtain approval for, and commercialize, its product candidates may be harmed, which could harm its business, operating
results, prospects or financial condition.
The FDA or comparable foreign regulatory
authorities may disagree with Elicio’s regulatory plans and it may fail to obtain regulatory approval of its product candidates.
The FDA standard for approval of a biologic generally requires two
adequate, well-controlled clinical trials, each convincingly demonstrating the product candidate’s safety and effectiveness, or one large and robust, well-controlled trial providing substantial evidence that the product candidate is safe and
effective for its proposed indication. Phase 3 clinical trials typically involve hundreds of patients, have significant costs and take years to complete. Product candidates studied for their safety and effectiveness in treating serious or
life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the
product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict
an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval,
the FDA usually requires a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the
drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals.
Elicio’s clinical trial results may not support either accelerated
or regular approval. The results of nonclinical studies and clinical trials may not be predictive of the results of later-stage clinical trials, and product candidates in
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later stages of clinical trials may fail to show the desired safety and efficacy
despite having progressed through nonclinical studies and initial clinical trials. In addition, Elicio’s product candidates could fail to receive regulatory approval for many reasons, including the following:
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of Elicio’s clinical
trials;
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the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full
population for which Elicio seeks approval;
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Elicio may be unable to demonstrate that its product candidates’ risk-benefit ratios for their proposed indications are
acceptable;
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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign
regulatory authorities for approval;
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Elicio may be unable to demonstrate that the clinical and other benefits of its product candidates outweigh their safety
risks;
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the FDA or comparable foreign regulatory authorities may disagree with Elicio’s interpretation of data from nonclinical
studies or clinical trials;
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the data collected from clinical trials of Elicio’s product candidates may not be sufficient to the satisfaction of the FDA
or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
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the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, Elicio’s own
manufacturing facilities, or a third-party manufacturer’s facilities with which it contracts for clinical and commercial supplies; and
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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a
manner rendering Elicio’s clinical data insufficient for approval.
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Failure to obtain regulatory approval to market any of Elicio’s
product candidates would significantly harm its business, results of operations, and prospects.
Elicio may not be successful in its efforts
to use and expand its discovery engine to build a pipeline of product candidates.
A key element of Elicio’s strategy is to use and expand its
discovery engine to build a pipeline of product candidates and progress these product candidates through preclinical and clinical development for the treatment of various diseases. Although its research efforts to date suggest that complex
amphiphilic molecules can deliver conventional immunomodulatory payloads including peptides, proteins and nucleic acids directly and preferentially to lymph nodes, this hypothesis may prove incorrect, or Elicio may not be able to identify a
product candidate that is safe or effective as a treatment for various cancers or for other diseases. It also may not be able to identify an amphiphile product candidate that it can demonstrate to be safe or effective, and it may not be able to
develop any other product candidates. Its scientific research that forms the basis of its efforts to discover product candidates based on its discovery engine is ongoing. Further, the scientific evidence to support the feasibility of developing
viable product candidates based on its platform has not been established. Elicio’s discovery engine may not be proven to be superior to competing technologies.
Even if Elicio is successful in building its pipeline of product
candidates, the potential product candidates that it identifies may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to have unacceptable toxicity or other characteristics that
indicate that they are unlikely to be products that will receive marketing approval from the FDA or other regulatory authorities or achieve market acceptance. Investment in biopharmaceutical product development involves significant risk that
any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, and become commercially viable. Elicio cannot provide you any assurance that it will be able to successfully
advance any of these additional product candidates through the development process. Its research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development or
commercialization for many reasons, including the following:
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Elicio’s platform may not be successful in identifying additional product candidates;
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Elicio may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates;
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Elicio’s product candidates may not succeed in nonclinical or clinical testing;
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a product candidate may upon further study demonstrate harmful side effects or other characteristics that indicate it is
unlikely to be effective or otherwise does not meet applicable regulatory criteria;
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competitors may develop alternatives that render Elicio’s product candidates obsolete or less attractive;
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product candidates Elicio develops may nevertheless be covered by third parties’ patents or other exclusive rights;
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the market for a product candidate may change during Elicio’s program so that the continued development of that product
candidate is no longer reasonable;
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a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and
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a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if
applicable.
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If any of these events occur, Elicio may be forced to abandon its
development efforts for a program or programs, or it may not be able to identify, discover, develop, or commercialize additional product candidates, which would have a material adverse effect on its business and could potentially cause it to
cease operations. Even if it receives FDA approval to market additional product candidates, whether for the treatment of cancers or other diseases, it cannot assure you that any such product candidates will be successfully commercialized,
widely accepted in the marketplace or more effective than other commercially available alternatives.
Elicio’s Phase 1 study of ELI-002 is
designed to require, as part of screening to determine whether subjects meet inclusion criteria, the use of an investigational in vitro diagnostic device. If Elicio is not able to successfully collaborate or partner with a third-party company
for the development and authorization of such a device, Elicio may not be able to receive marketing authorization for ELI-002.
The Phase 1 trial for ELI-002 (AMPLIFY-201) employs an
investigational in vitro diagnostic device, or IVD, that identifies gene mutations in KRAS and NRAS and detects circulating tumor DNA, or ctDNA, to identify patients who show signs of minimal residual disease in their blood, but before relapse
is detected in traditional radiographic scans. Based on Elicio’s Phase 1 study design, it must account for and address the investigational status of this device from a regulatory perspective through the course of clinical development (for
example, through the compliance with any applicable investigational device exemption requirements). Additionally, because this IVD will be used to select patients who may be appropriate to receive Elicio’s product candidate, the test will be
considered a companion diagnostic device. Companion diagnostic devices are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and Elicio anticipates that separate regulatory marketing authorization
will be required for the device prior to commercialization of ELI-002. Elicio plans to collaborate with appropriate companion diagnostic developers to seek marketing authorization from the FDA’s Center for Devices and Radiological Health, or
CDRH. If Elicio’s companion diagnostic partner experiences any delays in development or is not able to successfully develop and obtain marketing authorization for its companion diagnostic, or does not comply with the FDA’s medical device
regulations:
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the development of ELI-002 may be delayed because it may be difficult to identify patients for enrollment in Elicio’s
clinical trials in a timely manner;
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ELI-002 may not receive marketing approval if its safe and effective use depends on a companion diagnostic and none is
commercially available; and
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Elicio may not realize the full commercial potential of ELI-002 if it receives marketing approval if, among other reasons, it
is unable to appropriately identify patients or types of tumors with the specific genetic alterations targeted by these product candidates.
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Even if ELI-002 and any associated companion diagnostics are
approved for marketing, the need for companion diagnostics may slow or limit adoption of ELI-002. Although Elicio believes genetic testing is becoming more
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prevalent in the diagnosis and treatment of cancer, ELI-002 may be perceived
negatively compared to alternative treatments that do not require the use of companion diagnostics, either due to the additional cost of the companion diagnostic or the need to complete additional procedures to identify biomarkers prior to
administering Elicio’s product candidates.
If any of these events were to occur, Elicio’s business and growth
prospects would be harmed, possibly materially.
Elicio may seek designations under FDA
programs designed to facilitate and potentially expedite product candidate development, such as fast track or breakthrough therapy designation. Its product candidates may not receive any such designations or if they do receive such designations
they may not lead to faster development or regulatory review or approval and it does not increase the likelihood that its product candidates will receive marketing approval.
Elicio may seek designations under the FDA’s expedited programs
for serious conditions, such as fast track or breakthrough therapy designation, which are intended to facilitate and expedite the development or regulatory review or approval process for product candidates. Descriptions of the fast track and
breakthrough therapy designations are included under “Description of Elicio’s Business—Government Regulation and Product Approval—FDA Regulation—Fast Track, Breakthrough Therapy and Priority Review Designations.”
The granting of fast track or breakthrough therapy designation to
an investigational product is entirely within the FDA’s discretion. Accordingly, even if Elicio believes one of its product candidates meets the criteria for a designation, the FDA may disagree and instead determine not to grant such
designation. In any event, the receipt of a fast track or breakthrough therapy designation for a product candidate may not result in a faster development process, review, or approval compared to product candidates considered for approval under
conventional FDA procedures and does not assure ultimate marketing approval by the FDA. In addition, the FDA may later decide that the product candidate no longer meets the designation conditions, in which case any granted designations may be
revoked, or the agency may decide that the time period for review or approval of the product candidate will not be shortened.
If Elicio is unable to obtain approval via
the accelerated approval pathway, it may be required to conduct additional nonclinical studies or clinical trials. Even if it receives accelerated approval from the FDA, the FDA may seek to withdraw accelerated approval.
Elicio may seek an accelerated approval development pathway for
its product candidates. See “Description of Elicio’s Business—Government Regulation and Product Approval—FDA Regulation—Accelerated Approval Pathway” for a description of the accelerated approval
pathway.
If Elicio chooses to pursue accelerated approval, it intends to
seek feedback from the FDA or will otherwise evaluate its ability to seek and receive such accelerated approval. After Elicio’s evaluation of the feedback from the FDA or other factors, it may decide not to pursue or submit a BLA for
accelerated approval or any other form of expedited development, review or approval. Furthermore, if it submits an application for accelerated approval, there can be no assurance that such application will be accepted or that approval will be
granted on a timely basis, or at all. The FDA also could require Elicio to conduct further studies or trials prior to considering its application or granting approval of any type, and may require it to have a confirmatory trial to verify the
clinical benefit of the product underway and partially or fully enrolled before granting approval. Elicio might not be able to fulfill the FDA’s requirements in a timely manner, which would cause delays, or approval might not be granted because
its submission is deemed incomplete by the FDA.
Even if Elicio receives accelerated approval from the FDA, it will
be subject to rigorous post-marketing requirements, including the completion of confirmatory post-market clinical trials, submission to the FDA of periodic progress reports on confirmatory trials, and submission to the FDA of all promotional
materials prior to their dissemination. The FDA could seek to withdraw accelerated approval for multiple reasons, including if Elicio fails to conduct any required post-market study with due diligence; a post-market study does not confirm the
predicted clinical benefit; other evidence shows that the product is not safe or effective under the conditions of use; or Elicio disseminates promotional materials that are found by the FDA to be false and misleading. Under the Consolidated
Appropriations Act for 2023, the FDA may use expedited procedures to withdraw any product for which Elicio receives accelerated approval if its confirmatory trials fail to verify the purported clinical benefits.
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A failure to obtain accelerated approval or any other form of
expedited development, review or approval for a product candidate that Elicio may choose to develop would delay its commercialization of such product candidate, could increase the cost of development of such product candidate and could harm its
competitive position in the marketplace.
If Elicio applies for orphan drug
designation from the FDA, there is no guarantee that it will be able to obtain or maintain this designation, receive this designation for any of its other product candidates, or receive or maintain any corresponding benefits, including periods
of exclusivity.
Under the Orphan Drug Act, the FDA may grant orphan designation to
a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States when
there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. Orphan drug designation must be requested
before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. After the FDA grants
orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval
process.
If a product that has orphan drug designation subsequently
receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications,
including a BLA, to market the same biologic for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the
orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if one of
Elicio’s drug candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease. Furthermore, the FDA can waive orphan exclusivity if Elicio
is unable to manufacture sufficient supply of its product.
Elicio plans to seek orphan drug designation for some or all of
its product candidates in specific orphan indications for which there is a medically plausible basis for their use, but exclusive marketing rights in the United States may be limited if Elicio seeks approval for an indication broader than the
orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients
with the rare disease or condition. In addition, although Elicio intends to seek orphan drug designation for other product candidates, it may never receive such designations.
Elicio may expend its limited resources to
pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
Because Elicio has limited financial and managerial resources, it
focuses on research programs and product candidates that it identifies for specific indications. As a result, it may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have
greater commercial potential. its resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. Its spending on current and future research and development programs and
product candidates for specific indications may not yield any commercially viable products. If Elicio does not accurately evaluate the commercial potential or target market for a particular product candidate, it may relinquish valuable rights
to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for it to retain sole development and commercialization rights to such product candidate.
Any future product candidates for which
Elicio intends to seek approval as biologic products may face competition sooner than anticipated.
Even if Elicio is successful in achieving regulatory approval to
commercialize a product candidate ahead of its competitors, its product candidates may face competition from biosimilar products. In the United States, Elicio’s amphiphile product candidates are expected to be regulated by the FDA as biological
products, and Elicio intends to
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seek approval for these product candidates pursuant to the BLA pathway. The
enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar and interchangeable biological products based on a previously licensed reference product. Under the
BPCIA, an application for a biosimilar biological product cannot be approved by the FDA until 12 years after the original reference biological product was approved under a BLA. The law is complex and is still being interpreted and implemented
by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement BPCIA may be fully adopted by the FDA, any such processes could have a
material adverse effect on the future commercial prospects for Elicio’s product candidates.
Elicio believes that any of its product candidates approved as a
biological product under a BLA should qualify for the 12-year period of exclusivity available to reference biological products. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that
the FDA will not consider Elicio’s product candidates to be reference biological products pursuant to its interpretation of the exclusivity provisions of the BPCIA for competing products, potentially creating the opportunity for generic
follow-on biosimilar competition sooner than anticipated. Moreover, the extent to which a biosimilar product, once approved, will be substituted for any one of Elicio’s reference products in a way that is similar to traditional generic
substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing including whether a future competitor seeks an interchangeability designation for a
biosimilar of one of Elicio’s products. Under the BPCIA as well as state pharmacy laws, only interchangeable biosimilar products are considered substitutable for the reference biological product without the intervention of the health care
provider who prescribed the original biological product. However, as with all prescribing decisions made in the context of a patient-provider relationship and a patient’s specific medical needs, health care providers are not restricted from
prescribing biosimilar products in an off-label manner. In addition, a competitor could decide to forego the abbreviated approval pathway available for biosimilar products and to submit a full BLA for product licensure after completing its own
nonclinical studies and clinical trials. In such a situation, any exclusivity for which Elicio’s products candidates may be eligible under the BPCIA would not prevent the competitor from marketing its biological product as soon as it is
approved.
In Europe, the European Commission has granted marketing
authorizations for several biosimilar products pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years. In addition, companies may be developing biosimilar products in other
countries that could compete with Elicio’s products, if approved.
If competitors are able to obtain marketing approval for
biosimilars referencing Elicio’s product candidates, if approved, Elicio’s future products may become subject to competition from such biosimilars, whether or not they are designated as interchangeable, with the attendant competitive pressure
and potential adverse consequences. Such competitive products may be able to immediately compete with Elicio in each indication for which its product candidates may have received approval.
If Elicio encounters difficulties enrolling
patients in its clinical trials, its clinical development activities could be delayed or otherwise adversely affected.
Elicio may experience difficulties in patient enrollment in its
clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on Elicio’s ability to enroll a sufficient number of subjects who remain in the trial until its
conclusion. Elicio may not be able to initiate or continue conducting clinical trials for its product candidates if it is unable to locate and enroll a sufficient number of eligible subjects to participate in these trials. The enrollment of
patients depends on many factors, including:
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the number of clinical trials for other product candidates in the same therapeutic area that are currently in clinical
development, and Elicio’s ability to compete with such trials for subjects and clinical trial sites;
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the severity of the disease under investigation and the existence of current treatments;
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the perceived risks and benefits of the product candidate, including the potential advantages or disadvantages of the product
candidate being studied in relation to other available therapies;
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the subject eligibility criteria defined in the protocol, as well as Elicio’s ability to compensate subjects for their time
and effort;
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the size and nature of the patient population;
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the proximity and availability of clinical trial sites for prospective subjects;
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the design of the trial, including factors such as frequency of required assessments, length of the study and ongoing
monitoring requirements;
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subjects’ and investigators’ ability to comply with the specific instructions related to the trial protocol, proper
documentation, and use of the product candidate;
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Elicio’s ability to recruit clinical trial investigators with the appropriate competencies and experience;
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patient referral practices of physicians and the effectiveness of publicity created by clinical trials sites regarding the
trial;
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the ability to adequately monitor subjects during and after treatment and compensate them for their time and effort;
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the ability of Elicio’s clinical study sites, CROs, and other applicable third parties to facilitate timely enrollment;
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the ability of clinical trial sites to enroll subjects that meet all inclusion criteria and any patient exclusion due to
erroneous enrollment;
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Elicio’s ability to obtain and maintain subject informed consents; and
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the risk that subjects enrolled in clinical trials will drop out of the trials before completion of the study or not return
for post-study follow-up, especially subjects in control groups.
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In addition, Elicio’s clinical trials will compete with other
clinical trials for product candidates that are in the same therapeutic areas as its product candidates, and this competition will reduce the number and types of patients available to it, because some patients who might have opted to enroll in
Elicio’s trials may instead opt to enroll in a trial being conducted by one of its competitors. Because the number of qualified clinical investigators is limited, Elicio may conduct some of its clinical trials at the same clinical trial sites
that some of its competitors use, which will reduce the number of patients who are available for its clinical trials at such clinical trial sites. Moreover, because its product candidates represent a departure from more commonly used methods
for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, rather than enroll patients in any future clinical trial.
Elicio’s inability to enroll a sufficient number of subjects for
its clinical trials would result in significant delays and could require it to abandon one or more clinical trials altogether. Moreover, a significant number of withdrawn subjects would compromise the quality of its data. Enrollment delays in
its clinical trials may result in increased development costs for its product candidates, or the inability to complete development of its product candidates, which could cause the value of its company to decline, limit its ability to obtain
additional financing, and materially impair its ability to generate revenues.
Any product candidate Elicio advances into
clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent its regulatory approval or commercialization or limit its commercial potential.
As with most biological products, use of Elicio’s product
candidates could be associated with side effects or adverse events, which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. Undesirable side effects caused by any potential future product
candidate could cause regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities. While Elicio has
only recently initiated the AMPLIFY-201 trial, and it has not yet initiated clinical trials for any potential future product candidates, it is likely that there will be side effects associated with their use. Results of its clinical trials
could reveal a high and unacceptable severity and prevalence of these side effects. In such an event, its trials could be suspended or terminated, and the FDA or other regulatory authorities could order it to cease further development of or
deny approval of a product candidate for any or all targeted indications. Such side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of
these occurrences may materially and adversely affect Elicio’s business and financial condition and impair its ability to generate revenues.
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Further, clinical trials by their nature utilize a sample of
the potential patient population. With a limited number of patients and limited duration of exposure, rare and severe side effects of a product candidate may only be uncovered when a significantly larger number of patients are exposed to the
product candidate or when patients are exposed for a longer period of time.
If one or more of Elicio’s product candidates receives marketing
approval, and Elicio or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using Elicio’s products, a
number of potentially significant negative consequences could result, including:
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regulatory authorities may withdraw or limit their approvals of such products;
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regulatory authorities may require the addition of labeling statements, specific warnings or contraindications;
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Elicio may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects
for distribution to patients, a communication plan for health care providers, and/or other elements to assure safe use;
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Elicio may be required to change the way such products are distributed or administered, or change the labeling of the
products;
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the FDA or a comparable foreign regulatory authority may require Elicio to conduct additional clinical trials or costly
post-marketing testing and surveillance to monitor the safety and efficacy of the products;
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Elicio may decide to recall such products from the marketplace after they are approved;
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Elicio could be sued and held liable for harm caused to individuals exposed to or taking its products; and
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Elicio’s reputation may suffer.
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In addition, adverse side effects caused by any therapeutics that
may be similar in nature to Elicio’s product candidates could delay or prevent regulatory approval of its product candidates, limit the commercial profile of an approved label for its product candidates, or result in significant negative
consequences for its product candidates following marketing approval.
Any of these events could prevent Elicio from achieving or
maintaining market acceptance of the affected product candidates and could substantially increase the costs of commercializing its product candidates, if approved, and significantly impact its ability to successfully commercialize its product
candidates and generate revenues.
Elicio may form or seek strategic
partnerships or enter into additional licensing arrangements in the future, and it may not realize the benefits of such alliances or licensing arrangements.
From time to time, Elicio may form or seek strategic partnerships
or collaborations or enter into additional licensing arrangements with third parties that it believes will complement or augment its development and commercialization efforts with respect to its product candidates and any future product
candidates that it may develop. Any such relationships may require it to incur non-recurring and other charges, increase its near and long-term expenditures, issue securities that dilute its existing stockholders or disrupt its management and
business. These relationships also may result in a delay in the development of its product candidates if it becomes dependent upon the other party and such other party does not prioritize the development of Elicio’s product candidates relative
to its other development activities. Additionally, any collaborations, or licensing arrangements would be subject to the same product candidate development and compliance risks and obligations as Elicio would be if it were to develop the
product candidate on its own. Should any third party with which it enters into any of these arrangements not comply with the applicable regulatory requirements, it or they may be subject to regulatory enforcement action and it or they may be
delayed or prevented from obtaining marketing approval for the applicable product candidate.
In addition, Elicio faces significant competition in seeking
appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, Elicio may not be successful in its efforts to establish a strategic partnership or other alternative arrangement for its product candidates
because they may be deemed to be at too early of a stage of development for collaborative effort, and third parties may not view its product candidates as having the requisite potential to demonstrate safety and efficacy. If Elicio licenses
products or acquires businesses, it may not be able to realize the benefit of such transactions if it is unable to successfully integrate them with its existing
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operations and company culture. Any licensed products or acquired businesses may
also subject Elicio to the risk of regulatory enforcement should the product or business not be compliant with applicable regulatory requirements. Elicio cannot be certain that, following a strategic transaction or licensing arrangement, it
will achieve the revenue or specific net income that justifies such a transaction.
Elicio relies on contract manufacturing
organizations to manufacture its nonclinical and clinical pharmaceutical supplies and expects to continue to rely on CMOs to produce commercial supplies of any approved product candidate, and its dependence on CMOs could adversely impact its
business.
Elicio relies on contract manufacturing organizations (CMOs) for
the manufacture of nonclinical and clinical supplies for its product candidates and plans to continue to do so for commercial supplies should it receive marketing approval for any of its product candidates. This reliance also results in its
reduced control over the manufacture of its product candidates and the protection of its trade secrets and know-how from misappropriation or inadvertent disclosure, which may adversely affect its future business prospects. Nevertheless, as the
developer of the product candidates and sponsor of clinical trials involving such product candidates, it continues to have regulatory obligations to maintain oversight of the CMOs to ensure compliance with, among other things, contractual
obligations, specifications, and cGMP.
In complying with the manufacturing regulations of the FDA and
other comparable foreign regulatory authorities, Elicio and its third-party suppliers must spend significant time, money and effort in the areas of design and development, testing, production, record-keeping and quality control to assure that
the products meet applicable specifications and other regulatory requirements. Although its agreements with its CMOs require them to perform according to certain cGMP such as those relating to quality control, quality assurance and qualified
personnel, Elicio cannot control the conduct of its CMOs to implement and maintain these standards. If its CMOs do not successfully carry out their contractual duties, meet expected deadlines or manufacture its product candidates in accordance
with regulatory requirements, if there are disagreements between Elicio and such parties, or if such parties are unable to support the commercialization of any of its product candidates for which it obtains marketing approval, it may not be
able to produce, or may be delayed in producing sufficient product to meet its supply requirements. Any delays in obtaining adequate supplies on adequate terms with respect to Elicio’s product candidates and components, due to manufacturing
issues, global trade policies, or for other reasons, may delay the development, approval, or commercialization of its product candidates.
Elicio may not succeed in its efforts to establish manufacturing
relationships on commercially reasonable terms. Its product candidates may compete with other products and product candidates for access to manufacturing facilities, of which there are a limited number that operate under cGMP conditions and
that are both capable of manufacturing its product candidates and willing to do so. Even if it does establish such collaborations or arrangements, its CMOs may breach, terminate, or not renew these agreements. These facilities may also be
affected by the ongoing COVID-19 pandemic, natural disasters, such as floods or fires, or such facilities could face manufacturing issues, such as contamination or adverse regulatory findings following a regulatory inspection. Further, Elicio’s
CMOs may be temporarily unable to manufacture its product candidates due to government restrictions, requirements, or limitations. If its CMOs cease to manufacture its product candidates for any reason, Elicio would experience delays in
obtaining sufficient quantities of its product for it to meet commercial demand if it receives marketing approval or in advancing its development programs while it identifies and qualifies replacement suppliers. Elicio could also incur added
costs and delays in identifying and qualifying any such replacements and transferring any necessary technology and processes. The terms of a new arrangement may also be less favorable than any prior arrangements, if it is able to negotiate a
new arrangement at all. The addition of a new or alternative CMO may also require FDA approval and may have a material adverse effect on its business.
Elicio or its CMOs may also encounter shortages in the raw
materials or substances necessary to produce its product candidates in the quantities and at the quality needed for its nonclinical studies and clinical trials or, if any of its product candidates are approved for commercialization, to produce
its products on a commercial scale, meet an increase in demand, or compete effectively. Such shortages may occur for a variety of reasons, including capacity constraints, delays or disruptions in the market, and shortages caused by the purchase
of such materials by its competitors or others. Elicio’s or its third-party manufacturers’ failure to obtain the raw materials or substances necessary to manufacture sufficient quantities of its product candidates may have a material adverse
effect on its business.
Moreover, any problems or delays Elicio experiences in preparing
for commercial-scale manufacturing of a product candidate or component, including manufacturing validation, may result in a delay in a future marketing
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approval, if any, or commercial launch of any of its product candidates, should
they receive regulatory approval, or may impair its ability to manufacture commercial quantities or manufacture such quantities at an acceptable cost, which could result in the delay, prevention, or impairment of commercialization of its
product candidates, if approved, and could adversely affect its business. Furthermore, if the future manufacturers of the commercial supplies of its products, if approved, fail to deliver the required commercial quantities of its product
candidates on a timely basis and at commercially reasonable prices, it would likely be unable to meet demand for its products and it could lose potential revenues. The manufacture of biological products requires significant expertise and
capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of biologics often encounter difficulties in production, particularly in scaling up initial production. These problems
include difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel, and compliance with strictly enforced federal, state, and
foreign regulations. If Elicio’s manufacturers were to encounter any of these difficulties and were unable to perform as agreed, its ability to provide its product candidates for use in nonclinical studies or its current and planned clinical
trials, or, if any of its product candidates are approved, its ability to produce its product for commercial use, could be jeopardized.
In addition, all manufacturers of Elicio’s product candidates used
in clinical trials and of its products for commercial supply, should any of Elicio’s product candidates receive regulatory approval, must comply with cGMP regulations promulgated by the FDA and equivalent foreign regulatory authorities that are
applicable to both finished products and their active components used both for clinical and commercial supply. Regulatory authorities enforce these requirements through facility inspections. CMO facilities must be satisfactory to the FDA and
equivalent foreign regulatory authorities as determined by inspections that will be conducted after Elicio submits its marketing applications to the appropriate agencies and prior to product approval and commercialization. Its CMOs will also be
subject to continuing, periodic regulatory authority inspections should its product candidates receive marketing approval. Further, Elicio, in cooperation with its CMOs, must supply all necessary chemistry, manufacturing, and control
documentation to the FDA and equivalent foreign regulatory authorities in support of a marketing application on a timely basis.
The cGMP include quality control, quality assurance, and the
maintenance of records and documentation. Manufacturers of Elicio’s product candidates may be unable to comply with its specifications, cGMP or with other applicable regulatory requirements. Poor control of production processes can lead to the
introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of a product candidate that may not be detectable in final product testing. If its CMOs cannot successfully manufacture material
that conforms to its specifications and the applicable regulatory requirements, they may not be able to secure or maintain regulatory acceptance of their manufacturing facilities for the purpose of producing Elicio’s product candidates.
Deviations from manufacturing requirements may also require
reporting and remedial measures that may be costly and/or time-consuming for Elicio or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales, if any of its product
candidates receives regulatory approval, or the temporary or permanent closure of a facility. Any such remedial measure could materially harm its business. Any delay in obtaining products or product candidates that comply with the applicable
regulatory requirements may result in delays to nonclinical studies and clinical trials, or potential product approvals or commercialization. Any such delay may also require that Elicio conducts additional studies.
While Elicio is ultimately responsible for the manufacture and
regulatory compliance of its products and product candidates, it has little control over its manufacturers’ compliance with these regulations and standards other than through its contractual arrangements. If the FDA or a comparable foreign
regulatory authority does not find these facilities satisfactory for the manufacture of its products, if approved, or product candidates or if such authorities find such facilities to be noncompliant in the future, Elicio may need to find
alternative manufacturing facilities, which would significantly impact its ability to develop, obtain and maintain regulatory approval for or market its product candidates, if approved. Any new manufacturers would need to either obtain or
develop the necessary manufacturing know-how, and obtain the necessary equipment and materials, which may take substantial time and investment. Elicio must also receive FDA or other relevant comparable regulatory authority approval for the use
of any new manufacturers for commercial supply.
Elicio’s failure, or the failure of its third-party manufacturers,
to comply with applicable regulatory requirements may result in regulatory enforcement actions against its manufacturers or itself, including fines and civil and criminal penalties, including suspension of or restrictions on production,
injunctions, delay, withdrawal or denial of product
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approval or supplements to approved products, clinical holds or termination of
clinical studies, warning or untitled letters, regulatory authority communications warning the public about safety issues with a product, refusal to permit the import or export of a product, product seizure, detention, or recall, operating
restrictions, civil penalties, criminal prosecution, corporate integrity agreements, or consent decrees and equivalent foreign sanctions. Depending on the severity of any potential regulatory action, supplies of its product candidates or
products, if approved, could be interrupted or limited, which could have a material adverse effect on its business.
Elicio relies on third parties to conduct
some of its nonclinical studies and all of its clinical trials. If these third parties do not meet its deadlines or otherwise conduct the trials as required, its development programs could be delayed or unsuccessful and it may not be able to
obtain regulatory approval for or commercialize its product candidates when expected or at all.
Elicio does not have the ability to conduct all aspects of its
clinical trials itself and does not currently plan to independently conduct clinical trials. It uses third parties, such as CROs, to conduct, supervise, and monitor the AMPLIFY-201 trial and will rely upon such CROs, as well as medical
institutions, investigators and consultants, to conduct this trial and any future clinical trials that it may conduct in accordance with its protocols and applicable laws and regulations. In addition, it occasionally uses third parties to
conduct its nonclinical studies. Elicio’s CROs, investigators and other service providers play a significant role in the conduct of these trials and the subsequent collection and analysis of data from such trials.
Elicio’s service providers are not its employees and, except for
remedies available to it under its agreements with such third parties, as a result it will have less control over the timing, quality and other aspects of such nonclinical studies and clinical trials than it would have if it were to conduct
them on its own. If these third parties do not successfully carry out their contractual duties to Elicio, meet Elicio’s expected timelines or conduct its nonclinical studies or clinical trials in accordance with regulatory requirements or its
stated protocols, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to Elicio’s protocols or applicable regulatory requirements or for other reasons, Elicio’s trials
may need to be repeated, extended, delayed, or terminated. Further, Elicio may not be able to obtain, or may be delayed in obtaining, marketing approvals for its product candidates, it may fail or be delayed in its efforts to successfully
commercialize its product candidates, if approved. Such failures may also subject Elicio or its third-party service providers to regulatory enforcement actions. As a result, Elicio’s results of operations and the commercial prospects for its
product candidates could be harmed, its costs could increase and its ability to generate revenues could be delayed. To the extent it is unable to successfully identify and manage the performance of service providers in the future, its business
may be materially and adversely affected. Elicio’s third-party service providers may also have relationships with other entities, some of which may be its competitors, for whom they may also be conducting trials or other therapeutic development
activities that could harm its competitive position.
Agreements with third parties conducting or otherwise assisting
with Elicio’s nonclinical studies or clinical trials might terminate for a variety of reasons, including a failure to perform by such parties. If any of its relationships with these third parties terminate, it may not be able to enter into
arrangements with suitable alternative providers or do so on commercially reasonable terms. Switching or adding third parties involves additional cost and requires management time and focus. There is also a natural transition period when a new
third party commences work. As a result, if Elicio needs to enter into alternative arrangements, it could delay its product development activities and adversely affect its business. Although it carefully manages its relationships with its third
parties, there can be no assurance that it will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on its business, financial condition and prospects, and results of
operations.
Elicio’s reliance on third parties for development activities will
reduce its control over these activities. Nevertheless, Elicio is responsible for ensuring that each of its studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and its reliance on third
parties does not relieve it of its oversight and regulatory responsibilities. For example, it will remain responsible for ensuring that each of its trials is conducted in accordance with the general investigational plan and protocols for that
trial. Elicio must also ensure that its nonclinical studies are conducted in accordance with good laboratory practice (GLP) requirements, as appropriate. Moreover, the FDA and comparable foreign regulatory authorities require it to comply with
established good clinical practice (GCP) standards for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of
trial participants are protected. In addition, Elicio’s clinical trials must be conducted with product candidates that were produced under cGMP conditions. Regulatory authorities enforce these requirements through periodic inspections of trial
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clinical and nonclinical investigators, manufacturers, and trial sites. If Elicio
or any of its third-party service providers fails to comply with applicable regulatory requirements, it or they may be subject to enforcement or other legal actions, the data generated in its trials may be deemed unreliable and the FDA or
comparable foreign regulatory authorities may require it to perform additional studies, which may significantly delay its clinical development plans and the regulatory approval process. Elicio cannot assure you that upon inspection by a given
regulatory authority, such regulatory authority will determine that Elicio, its third-party service providers, or clinical trial sites is in substantial compliance with the applicable regulatory requirements.
In addition, Elicio will be required to report certain financial
interests of its third-party investigators if these relationships exceed certain financial thresholds or meet other criteria. The FDA or comparable foreign regulatory authorities may question the integrity of the data from those clinical trials
conducted by investigators who may have conflicts of interest. Elicio is also required to register certain clinical trials and post the results of certain completed clinical trials on a government-sponsored database, clinicaltrials.gov, within
specified timeframes. Failure to do so can result in enforcement actions and adverse publicity.
Elicio relies on other third parties to
store and distribute its product candidates for nonclinical studies and clinical trials that it conducts.
Elicio also relies on other third parties to store and distribute
its product candidates for the nonclinical studies and clinical trials that it is conducting or plan to conduct. Any performance failure, or failure to comply with applicable regulations, on the part of its distributors could delay development,
the regulatory approval process, or potential commercialization of its product candidates, producing additional losses and depriving it of potential product revenue.
Elicio may incur substantial product
liability or indemnification claims relating to the clinical testing of its product candidates.
Elicio faces an inherent risk of product liability exposure
related to the testing of its product candidates in human clinical trials, and claims could be brought against it if the use or misuse of one of its product candidates causes, or merely appears to have caused, personal injury or death. Elicio
will face an even greater risk of product liability if it receives marketing approval for and commercialize any of its product candidates. Any such product liability claims may include allegations of defects in manufacturing, defects in design,
a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. Product liability claims might be brought against it by consumers,
health care providers or others using, administering or selling its products.
Any claims against Elicio, regardless of their merit, could
severely harm its financial condition, strain its management and other resources or destroy the prospects for commercialization of the product which is the subject of any such claim. For instance, product liability claims may result in:
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loss of revenue from decreased demand for Elicio’s products and/or product candidates;
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impairment of Elicio’s business reputation or financial stability;
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incurred costs and time of related litigation;
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substantial monetary awards to patients or other claimants, and loss of revenue;
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diversion of management attention;
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withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs;
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the inability to commercialize Elicio’s product candidates;
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significant negative media attention;
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decrease in Elicio’s stock price;
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initiation of investigations, and enforcement actions by regulators; and/or
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product recalls, withdrawals, revocation of approvals, or labeling, marketing or promotional restrictions.
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In connection with Elicio’s development of a product candidate for
COVID-19, because the product may be developed under an emergency declaration, it may be eligible for limited liability protection under the Public
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Readiness and Emergency Preparedness Act (PREP Act). The PREP Act provides limited
immunity for manufacturers from claims for losses arising out of the administration or use of a “covered countermeasure.” However, the PREP Act does not provide complete immunity as injured persons may still bring a suit for “willful
misconduct” under some circumstances. The PREP Act also does not provide immunity against federal enforcement actions or claims under federal law for equitable relief. “Covered countermeasures” include “qualified pandemic or epidemic products”,
such as those for COVID-19. For these immunities to apply, the Secretary of the U.S. Department of Health and Human Services (HHS) must issue a declaration of a public health emergency, as was done for COVID-19. To be covered by PREP Act
immunity, activities and products must further meet the criteria set forth in the HHS declaration of immunity from liability, and the therapeutic must be authorized by the FDA, or authorized for investigational or emergency use for the
applicable emergency. The federal government has continuously revised its PREP Act declaration and has provided multiple advisory opinions regarding its interpretation of the PREP Act declarations throughout the COVID-19 pandemic. Accordingly,
interpretation of the scope of the PREP Act may change. Additionally, the PREP Act may not provide adequate coverage or immunity for all potential claims related to Elicio’s COVID-19 product candidate.
If Elicio cannot successfully defend itself against these claims,
it will incur substantial liabilities or be required to limit development or commercialization of its products or product candidates. Although it maintains product liability and clinical trial insurance coverage, it may be inadequate to cover
all liabilities that it may incur. Elicio anticipates that it will need to increase its insurance coverage as it continues clinical development of its product candidates and if it successfully commercializes any medicine. Insurance coverage is
increasingly expensive. It may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
If any product candidate that Elicio
successfully develops does not achieve broad market acceptance among physicians, patients, health care payors and the medical community, the revenues that it generates from their sales will be limited.
Even if Elicio’s product candidates receive regulatory approval,
they may not gain market acceptance among physicians, patients, health care payors and the medical community. Market acceptance of its products by the medical community, patients, and third-party payors will depend on a number of factors, some
of which are beyond its control, including:
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the efficacy of Elicio’s products and the prevalence and severity of any adverse events;
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any potential advantages or disadvantages when compared to alternative treatments;
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interactions of Elicio’s products with other medicines patients are taking and any restrictions on the use of its products
together with other medications;
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the clinical indications for which the products are approved and the approved claims that Elicio may make for the products;
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limitations or warnings contained in the product’s FDA-approved labeling, including potential limitations or warnings for
such products that may be more restrictive than other competitive products;
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changes in the standard of care for the targeted indications for such product candidates, which could reduce the marketing
impact of any claims that Elicio could make following approval, if obtained;
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the safety, efficacy, and other potential advantages over alternative treatments, such as relative convenience and ease of
administration of such products, and the availability of alternative treatments already used or that may later be approved;
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cost of treatment versus economic and clinical benefit in relation to alternative treatments or therapies;
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the availability of formulary coverage and adequate coverage or reimbursement by third parties, such as insurance companies
and other health care payors, and by U.S. and international government health care programs, including Medicaid and Medicare;
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the price concessions required by third-party payors and government health care programs to obtain coverage and payment;
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the extent and strength of Elicio’s marketing and distribution of such products;
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distribution and use restrictions imposed by the FDA and equivalent foreign regulatory authorities with respect to such
products or to which Elicio agrees, for instance, as part of a REMS or voluntary risk management plan;
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the timing of market introduction of such products, as well as competitive products;
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Elicio’s ability to offer such products for sale at competitive prices;
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Elicio’s ability to offer programs to facilitate market acceptance and insurance coverage from public and private insurance
companies, provide patient assistance, and transition patient coverage;
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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
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the extent and strength of Elicio’s third-party manufacturer and supplier support;
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the approval of other new products, including biosimilar products that may be priced at a substantially lower price than
Elicio expects to offer its product candidates for, if approved;
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adverse publicity about the product or favorable publicity about competitive products;
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the success of any efforts to educate the medical community and third-party payors regarding Elicio’s products, which efforts
may require significant resources and may not be successful; and
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potential product liability claims.
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If any product candidate is approved but does not achieve an
adequate level of acceptance by physicians, hospitals, health care payors and patients, Elicio may not generate sufficient revenue from these products and may not become or remain profitable.
If Elicio is unable to establish sales and
marketing capabilities or enter into agreements with third parties to sell and market any product candidates it may develop, it may not be successful in commercializing those product candidates if and when they are approved.
Elicio does not have a sales or marketing infrastructure and it
has limited experience in the sale, marketing, or distribution of pharmaceutical products. To achieve commercial success for any approved medicine for which it retains sales and marketing responsibilities, it must either develop a sales and
marketing organization or outsource these functions to third parties. In the future, Elicio may choose to build a focused sales, marketing, and commercial support infrastructure to sell, or participate in sales activities with its collaborators
for, some of its current and future product candidates if and when they are approved.
There are risks involved with both establishing and managing
Elicio’s own commercial capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force or reimbursement specialists is expensive and time-consuming and could delay
any product launch. If the commercial launch of a product candidate for which Elicio recruits a sales force and establish marketing and other commercialization capabilities is delayed or does not occur for any reason, Elicio would have
prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and Elicio’s investment would be lost if it cannot retain or reposition its commercialization personnel.
Factors that may inhibit Elicio’s efforts to commercialize product
candidates on its own include:
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Elicio’s inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service,
medical affairs, and other support personnel;
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the inability of sales personnel to obtain access to physicians to discuss Elicio’s products;
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the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement, and other
acceptance by payors, and to secure adequate coverage;
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reduced realization on government sales from mandatory discounts, rebates and fees, and from price concessions to private
health plans and pharmacy benefit managers necessitated by competition for access to managed formularies;
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the clinical indications for which the products are approved and the claims that Elicio may make for the products, as well as
any limitations on use or warnings;
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the costs associated with training sales and marketing personnel on legal and regulatory compliance matters and monitoring
their actions, and any liability for sales or marketing personnel who fail to comply with the applicable legal and regulatory requirements;
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restricted or closed distribution channels that make it difficult to distribute Elicio’s products to different segments of
the patient population;
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the lack of complementary medicines to be offered by sales personnel, which may put Elicio at a competitive disadvantage
relative to companies with more extensive product lines; and
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unforeseen costs and expenses associated with creating an independent commercialization organization.
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If Elicio enters into arrangements with third parties to perform
sales, marketing, commercial support, and distribution services, its product revenues or the profitability of these product revenues to it may be lower than if it were to market and sell any product it may develop itself. In addition, Elicio
may not be successful in entering into arrangements with third parties to commercialize its products or may be unable to do so on terms that are favorable to it. Elicio may have little control over such third parties, and any of them may fail
to devote the necessary resources and attention to sell and market its products effectively. If Elicio does not establish commercialization capabilities successfully, either on its own or in collaboration with third parties, it will not be
successful in commercializing any products it may develop.
Elicio faces significant competition in an
environment of rapid technological change, and there is a possibility that its competitors may achieve regulatory approval before it or develop therapies that are safer or more advanced or effective than Elicio’s, which may harm its financial
condition and its ability to successfully market or commercialize any product candidates it may develop.
The development and commercialization of new therapeutic biologics
is highly competitive. Moreover, the immunotherapy field is characterized by rapidly changing technologies, significant competition, and a strong emphasis on intellectual property. Elicio will likely face competition with respect to any product
candidates that it may seek to develop or commercialize in the future from numerous pharmaceutical and biotechnology organizations, as well as from academic institutions, government agencies and other public and private research organizations
for its current and future product candidates. Elicio’s commercial success will be reduced or eliminated if its competitors develop products that are safer, more effective or less costly than Elicio’s.
A number of well-resourced pharmaceutical and biotechnology
companies with established relationships with patient organizations are developing products to inhibit RAS mutated cancers. These products, as well as marketing campaigns by competitors and clinical trial results with competitive products,
could significantly diminish Elicio’s ability to market and sell ELI-002 for RAS mutated cancers, if approved. For example, Amgen Inc., or Amgen, Mirati Therapeutics, Inc., or Mirati, and Revolution Medicines, Inc., among others, have developed
small molecule therapies for the treatment of KRAS mutated cancer including G12C and other alleles. Other companies in the immunotherapy and cancer vaccine sector include BioNTech SE, Gilead Sciences Inc., Novartis International AG, Gritstone
Oncology, Inc., Hookipa Pharma Inc., Targovax ASA, Moderna, Inc., Roche Holding Ltd./Genentech, Inc., Merck & Co., Inc., Bristol Myers Squibb Co., and AstraZeneca Plc. Closest in mechanism to ELI-002 is the Moderna mRNA-5671 cancer vaccine,
which is currently in Phase 1 clinical development. While many of these programs are in preclinical stages or Phase 1 clinical trials, Amgen and Mirati have products that are approved by the FDA for the treatment of adult patients with KRAS
G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy. Although ELI-002 is being evaluated as an earlier line of therapy (before metastatic disease can be observed
on radiographs), it may compete with existing and new therapies that may be approved in the future.
Many of Elicio’s current or potential competitors, either alone or
with their collaboration partners, may have significantly greater financial resources and expertise in research and development, manufacturing, nonclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing
approved products than Elicio does. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of Elicio’s competitors. Smaller or early-stage
companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with Elicio in recruiting and retaining qualified scientific and
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and establishing clinical trial sites and patient registration for clinical
trials, as well as in acquiring technologies complementary to, or necessary for, Elicio’s programs. Elicio’s commercial opportunity could be reduced or eliminated if its competitors develop and commercialize product candidates that are safer,
more effective, have fewer or less severe side effects, are more convenient, or are less expensive than the product candidates it may develop or that would render any of its product candidates obsolete or non-competitive. Elicio’s competitors
also may obtain FDA or other regulatory approval for their product candidates more rapidly than it may obtain approval for its product candidates, which could result in its competitors establishing a strong market position before Elicio is able
to enter the market.
Elicio’s commercial opportunity may also be reduced or limited if
it or its partners are unable to scale up the manufacture of its product candidates to meet clinical or commercial requirements. ELI-002 is comprised of eight active pharmaceutical ingredients (APIs), with peptides and nucleotides with a lipid
modification. The compositions Elicio seeks to develop may exhibit poor pharmaceutical properties, and formulation, purification and stable storage could be challenging.
In addition, Elicio could face litigation with respect to the
validity and/or scope of patents relating to its competitors’ products. The availability of competitive products could limit the demand and the price it is able to charge for its products. Further, intellectual property protection for the
amphiphile components of Elicio’s product candidates is dynamic and rapidly evolving. The scope of intellectual property protection for its AMP platform may be limited, and its commercial opportunity may be reduced or limited if its competitors
are able to acquire or develop the same or similar technologies.
Corporate and academic collaborators may
take actions to delay, prevent, or undermine the success of Elicio’s products.
Elicio’s operating and financial strategy for the development,
clinical testing, manufacture, and commercialization of product candidates is heavily dependent on Elicio’s entering into collaborations with corporations, academic institutions, licensors, licensees, and other parties and it may not be
successful in establishing such collaborations. Some of its existing collaborations are, and future collaborations may be, terminable at the sole discretion of the collaborator. Replacement collaborators might not be available on attractive
terms, or at all. The activities of any collaborator will not be within Elicio’s control and may not be within its power to influence. Any collaborators may not perform their obligations to Elicio’s satisfaction, or at all, it may not derive
any revenue or profits from such collaborations, and any collaborators may ultimately compete with it. If any collaboration is not pursued, Elicio may require substantially greater capital to undertake development and marketing of its proposed
products and may not be able to develop and market such products effectively, if at all. In addition, a lack of development and marketing collaborations may lead to significant delays in introducing proposed products into certain markets and/or
reduced sales of proposed products in such markets.
Data provided by collaborators and others
upon which Elicio relies that has not been independently verified could turn out to be false, misleading, or incomplete.
Elicio relies on third-party vendors, scientists and collaborators
to provide it with significant data and other information related to its projects, clinical trials and its business. If such third parties provide inaccurate, misleading or incomplete data, Elicio’s business, prospects and results of operations
could be materially adversely affected.
Even if Elicio is able to commercialize any
product candidates, such products may become subject to unfavorable pricing regulations, reimbursement practices, or health care reform initiatives, which would harm its business.
The regulations that govern pricing, and reimbursement for new
medicines vary widely from country to country, and current and future legislation may change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Outside the United States, some
countries require approval of the sale price of a medicine before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription
pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, Elicio might obtain marketing approval for a product candidate in a particular country, but then be subject to price
regulations that delay or might even prevent its commercial launch of the product candidate, possibly for lengthy time periods, and negatively impact the revenues it is able to generate from the sale of the product candidate in that country.
Adverse pricing limitations may hinder its ability to recoup its investment in one or more product candidates it may develop, even if any such product candidates obtain marketing approval.
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Elicio’s ability to commercialize any product candidates
successfully also will depend in part on the extent to which reimbursement for these product candidates and related treatments will be available from government authorities or health care programs, private health plans, and other organizations.
Even if Elicio succeeds in bringing one or more products to the market, these products may not be considered medically necessary and/or cost-effective, and the amount reimbursed for any products may be insufficient to allow it to sell its
products on a competitive basis. At this time, Elicio is unable to determine their cost effectiveness or the likely level or method of reimbursement for its product candidates. Government authorities and third-party payors, such as private
health plans, decide which medications they will pay for and establish reimbursement levels. A primary trend in the U.S. health care industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to
control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are challenging the prices charged for medical products and requiring that biopharmaceutical companies provide them
with predetermined discounts from list prices. Novel medical products, if covered at all, may be subject to enhanced utilization management controls designed to ensure that the products are used only when medically necessary. Such utilization
management controls may discourage the prescription or use of a medical product by increasing the administrative burden associated with its prescription or creating coverage uncertainties for prescribers and patients. Elicio cannot be sure that
reimbursement will be available for any product candidate that it commercializes and, if reimbursement is available, that the level of reimbursement will be adequate. Reimbursement may impact the demand for, or the price of, any product
candidate for which it obtains marketing approval. If reimbursement is not available or is available only to limited levels, it may not be able to successfully commercialize any product candidate for which it obtains marketing approval.
Elicio currently expects that any drugs it develops may need to be
administered under the supervision of a physician on an outpatient basis. Under currently applicable U.S. law, certain therapeutic products that are not usually self-administered (such as most injectable drugs and biologics) may be eligible for
coverage under the Medicare Part B program if:
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they are incident to a physician’s services;
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they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered
according to accepted standards of medical practice; and
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they have been approved by the FDA and meet other requirements of the statute.
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There may be significant delays in obtaining reimbursement for
newly approved product candidates, and coverage may be more limited than the purposes for which the product candidate is approved by the FDA or other regulatory authorities. Patients who are prescribed medications for the treatment of their
conditions, and their prescribing physicians, generally rely on third-party payors to pay all or part of the costs associated with their prescription medications. Patients are unlikely to use Elicio’s products unless coverage is provided and
payment is adequate to cover all or a significant portion of the cost of its products. Therefore, coverage and adequate payment is critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that
disfavor new products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Moreover, eligibility for reimbursement does not imply that any product candidate will be paid for in all
cases or at a rate that covers Elicio’s costs, including research, development, manufacture, sale, and distribution. Interim reimbursement levels for new product candidates, if applicable, may also not be sufficient to cover Elicio’s costs and
may not be made permanent. Reimbursement rates may vary according to the use of the product candidate and reimbursement in the clinical setting in which it is used may be based on reimbursement levels already set for lower cost therapies or
medicines and may be incorporated into existing payments for other services. Net prices for product candidates may be reduced by mandatory discounts or rebates required by government health care programs or private payors and by any future
relaxation of laws that presently restrict imports of medicines from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting
their own reimbursement rates. However, no uniform policy requirement for coverage and reimbursement for drug products exists among third-party payors in the United States. Therefore, coverage and reimbursement for drug products can differ
significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require Elicio to provide scientific and clinical support for the use of its products to each payor
separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Elicio’s inability
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to promptly obtain coverage and profitable payment rates from both
government-funded and private payors for any approved product candidates it may develop could have a material adverse effect on its operating results, its ability to raise capital needed to commercialize medicines, and its overall financial
condition.
Elicio believes that the efforts of governments and third-party
payors to contain or reduce the cost of health care and legislative and regulatory proposals to broaden the availability of health care will continue to affect the business and financial condition of pharmaceutical and biopharmaceutical
companies. A number of legislative and regulatory changes in the health care system in the United States and other major health care markets have been proposed and/or adopted in recent years, and such efforts have expanded substantially in
recent years.
In particular, in March 2010, the Patient Protection and
Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act(ACA) was signed into law. This legislation changed the system of health care insurance and benefits and was intended to broaden access to health
care coverage, enhance remedies against fraud and abuse, add transparency requirements for the health care and health insurance industries, impose taxes and fees on the health care industry, impose health policy reforms, and control costs. This
law also contains provisions that would affect companies in the pharmaceutical industry and other health care related industries by imposing additional costs and changes to business practices. Since its enactment, there have been judicial and
congressional challenges to certain aspects of the ACA. The uncertainty around the future of the ACA, and in particular the impact to reimbursement levels, may lead to uncertainty or delay in the purchasing decisions of Elicio’s customers,
which may in turn negatively impact its product sales. Elicio continues to evaluate the effect that the ACA has or any potential changes to the ACA could have on its business. Additional federal and state legislative and regulatory developments
are likely, and Elicio expects ongoing initiatives in the United States to increase pressure on drug and biologic pricing and reimbursement. Such reforms could have an adverse effect on anticipated revenues from product candidates that Elicio
may successfully develop and for which it may obtain regulatory approval and may affect its overall financial condition and ability to develop product candidates.
If the market opportunities for any of
Elicio’s product candidates are smaller than it believes they are, its potential revenues may be adversely affected, and its business may suffer.
Elicio focuses certain research and product development pipelines
and its product candidates on lymph node-directed immunotherapies for cancer and infectious diseases. ELI-002 is a KRAS therapeutic vaccine in clinical development for the potential treatment of several cancer types with KRAS mutations. ELI-002
targets six position 12 and one position 13 KRAS mutations, representing approximately 25% of tumors. The AMPLIFY-201 trial focuses on pancreatic cancer and colorectal cancer.
While Elicio believes that the cancer types to be included in its
early-stage clinical trials have a large KRAS mutation positive patient population in the United States, its understanding of both the number of patients who have these diseases, as well as the subset of people with these diseases who have the
potential to benefit from treatment with its product candidates, is based on estimates. These estimates may prove to be incorrect and new studies may reduce the estimated incidence or prevalence of these diseases. By example, because some of
the cancer indications that Elicio is targeting are rare, certain estimates are based upon studies with small patient populations. Moreover, because Elicio’s product candidates, such as ELI-002 target specific positions on a mutation, not all
patients with the mutation will be treatment candidates. As a result, the number of patients in the United States may turn out to be lower than expected, may not be otherwise eligible for treatment with ELI-002, or patients may become
increasingly difficult to identify and access for clinical trials, all of which could adversely affect Elicio’s business, financial condition, results of operations and prospects.
If Elicio or any CMOs and suppliers it
engages fail to comply with environmental, health, and safety laws and regulations, Elicio could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of its business.
Elicio and any CMOs and suppliers it engages are subject to
numerous federal, state, and local environmental, health, and safety laws, regulations, and permitting requirements, including those governing laboratory procedures; the generation, handling, use, storage, treatment, and disposal of hazardous
and regulated materials and wastes; the emission and discharge of hazardous materials into the ground, air, and water; and employee health and safety. Elicio’s operations involve the use of hazardous and flammable materials, including chemicals
and biological materials. Elicio’s operations also produce hazardous waste. Elicio generally contracts with third parties for the disposal of these materials and wastes. Elicio cannot eliminate the risk of contamination or injury from these
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materials. In the event of contamination or injury resulting from its use of
hazardous materials, it could be held liable for any resulting damages, and any liability could exceed its resources. Under certain environmental laws, Elicio could be held responsible for costs relating to any contamination at its current or
past facilities and at third-party facilities. It also could incur significant costs associated with civil or criminal fines and penalties.
Compliance with applicable environmental laws and regulations may
be expensive, and current or future environmental laws and regulations may impair Elicio’s research and product development efforts. In addition, Elicio cannot entirely eliminate the risk of accidental injury or contamination from these
materials or wastes. Although it maintains workers’ compensation insurance to cover it for costs and expenses it may incur due to injuries to its employees resulting from the use of hazardous materials, this insurance may not provide adequate
coverage against potential liabilities. Elicio does not carry specific biological or hazardous waste insurance coverage, and its property, casualty, and general liability insurance policies (under which it currently has an aggregate of
approximately $5.0 million in coverage) specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, Elicio could be held liable
for damages or be penalized with fines in an amount exceeding its resources, and its clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on its business, financial condition, results of
operations, and prospects.
In addition, Elicio may incur substantial costs in order to comply
with current or future environmental, health, and safety laws, regulations, and permitting requirements. These current or future laws, regulations, and permitting requirements may impair its research, development, or production efforts. Failure
to comply with these laws, regulations, and permitting requirements also may result in substantial fines, penalties, or other sanctions or business disruptions, which could have a material adverse effect on its business, financial condition,
results of operations, and prospects.
Any CMOs and suppliers Elicio engages will also be subject to
these and other environmental, health, and safety laws and regulations. Liabilities they incur pursuant to these laws and regulations could result in significant costs or an interruption in operations, which could have a material adverse effect
on its business, financial condition, results of operations, and prospects.
Elicio’s technologies are novel, and any
product candidates it develops may be complex and difficult to manufacture on a clinical or commercial scale. Elicio could experience delays in satisfying regulatory authorities or production problems that result in delays in its development or
commercialization programs, limit the supply of its product candidates it may develop, or otherwise harm its business.
Elicio’s AMP platform is novel, and the manufacture of products on
the basis of its platform is untested at a large scale. Any current and future product candidates will likely require processing steps that are more complex than those required for most chemical pharmaceuticals. Problems with the manufacturing
process, even minor deviations from the normal process, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims, insufficient inventory, or potentially delay progression
of its regulatory filings. Even if Elicio successfully develops product candidates, it may encounter problems achieving adequate quantities and quality of clinical-grade materials that meet FDA or other comparable applicable foreign standards
or specifications with consistent and acceptable production yields and costs. If Elicio or its contract manufacturers are unable to scale its manufacturing at the same levels of quality and efficiency, it may not be able to supply the required
number of doses for its current or planned clinical trials or for commercial supply, if any of its product candidates receives regulatory approval, and its business could be harmed.
As product candidates proceed through nonclinical studies to
clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are tested and then altered along the way in an effort to optimize
processes and results. Elicio plans to transform its current version of ELI-002, with two peptides (ELI-002-2P), to a future version of ELI-002, with seven peptides (ELI-002-7P), as part of its product development activities subject to receipt
of additional funding following the Merger. Any such changes could cause any product candidates it may develop to perform differently and affect the results of clinical trials conducted with the materials manufactured using altered processes.
Such changes may also require a new investigational new drug application (IND) to be filed for ELI-002-7P, additional testing, FDA notification, and FDA authorization. This could delay completion of clinical trials, require the conduct of
bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of Elicio’s product candidates and jeopardize its ability to commence sales and generate revenue. For instance, the FDA may
require that Elicio conducts a comparability study that evaluates the potential differences in the product
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candidate resulting from the change. Delays in designing and completing such a
study to the satisfaction of the FDA could delay or preclude Elicio’s development and commercialization plans, and the regulatory approval of its product candidates. Any of the foregoing could limit Elicio’s future revenues and growth. Any
changes would also require that it devotes time and resources to manufacturing development and would also likely require additional testing and regulatory actions on its part, which may delay the development of its product candidates.
In addition, the FDA and other regulatory authorities may require
Elicio to submit samples of any lot of any approved product together with the protocols showing the results of applicable tests at any time. Under some circumstances, a regulatory authority may require that Elicio does not distribute a lot
until the agency authorizes its release. Slight deviations in the manufacturing process, including those affecting quality attributes and stability of encapsulation, may result in unacceptable changes in the product that could result in lot
failures or product recalls. Lot failures or product recalls could cause Elicio to delay clinical trials or product launches, which could be costly to it and otherwise harm its business, financial condition, results of operations, and
prospects.
Elicio also may encounter problems hiring and retaining the
experienced scientific, quality control, and manufacturing personnel needed to manage its manufacturing process, which could result in delays in its production or difficulties in maintaining compliance with applicable regulatory requirements.
The manufacture of biopharmaceutical products is complex and
requires significant expertise, including the development of advanced manufacturing techniques and process controls. For example, given the aseptic controls required for the manufacture of Elicio’s product candidates, if contaminants are
discovered in Elicio’s supply of product candidates or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. Any such contamination could
materially harm its ability to produce product candidates on schedule and could delay its development programs and results of operations and cause reputational damage. Elicio cannot assure that any such issues relating to the manufacture of
ELI-002 or any other product candidate will not occur in the future or that significant delays would not occur as a result of any such issue.
ELI-002 drug substances and drug products are supplied by multiple
manufacturers at present. Any problems in Elicio’s manufacturing process or the facilities with which it contracts to make, store or ship its product candidates or any problems caused by it, its vendors or other factors not in its control could
result in the loss of usable product or prevent or delay the delivery of product candidates to patients in its clinical trials, including the AMPLIFY-201 trial. Any such loss or delay could materially delay Elicio’s development timelines and
harm its business, financial condition and results of operations. Such losses or delays could also make it a less attractive collaborator for potential partners, including larger pharmaceutical companies and academic research institutions,
which could limit its access to additional attractive development programs. Problems with third-party manufacturing processes or facilities also could restrict Elicio’s ability to ensure sufficient clinical material for any clinical trials it
may be conducting or is planning to conduct and meet market demand for any product candidates it may develop, obtain regulatory approval for, and commercialize.
This Merger may limit Elicio’s ability to use
some or all of its net operating loss carryforwards in the future.
The ultimate realization of Elicio’s deferred income tax assets is
dependent upon generating future taxable income. It has recorded a full valuation allowance against its deferred income tax assets. The valuation allowance may fluctuate as conditions change. Elicio’s ability to utilize net operating loss
carryforwards to offset its future taxable income and/or to recover previously paid taxes would be limited if it were to undergo an “ownership change” within the meaning of Section 382 of the Code. In general, an “ownership change” occurs
whenever the percentage of the stock of a corporation owned by “5-percent stockholders” (within the meaning of Section 382 of the Code) increases by more than 50 percentage points over the lowest percentage of the stock of such corporation
owned by such “5-percent stockholders” at any time over the testing period. An ownership change under Section 382 of the Code would establish an annual limitation to the amount of NOLs Elicio could utilize to offset its taxable income in any
single year. The application of these limitations might prevent full utilization of the deferred tax assets attributable to its net operating loss carryforwards.
Elicio has not yet formally determined the amount of the
cumulative change in its ownership resulting from this Merger or other transactions, or any resulting limitations on its ability to utilize its NOL carryforwards and other tax attributes. As a result, if Elicio earns net taxable income, its
ability to use its pre-change net operating loss
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carryforwards to offset U.S. federal taxable income may be subject to limitations,
which could potentially result in increased future tax liability to it. If an ownership change occurs and Elicio’s ability to use its net operating loss carryforwards is materially limited, it could harm Elicio’s future operating results by
effectively increasing its future tax obligations.
Elicio’s insurance policies are expensive
and protect it only from some business risks, which will leave it exposed to significant uninsured liabilities.
Elicio carries insurance for most categories of risk that its
business may encounter; however, it may not have adequate levels of coverage. Elicio currently maintains general liability, property, workers’ compensation, products liability and directors’ and officers’ insurance, along with an umbrella
policy. It may not be able to maintain existing insurance at current or adequate levels of coverage. Any significant uninsured liability may require it to pay substantial amounts, which would adversely affect its cash position and results of
operations.
Elicio’s success will depend upon
intellectual property and proprietary technologies, and it may be unable to protect its intellectual property.
Elicio’s success will depend, in large part, on obtaining and
maintaining patent protection and trade secret protection for its product candidates and their formulations and uses, as well as successfully defending these patents against third-party challenges. If Elicio or its licensors fail to
appropriately prosecute and maintain patent protection for its product candidates, its ability to develop and commercialize these product candidates may be adversely affected and it may not be able to prevent competitors from making, using and
selling competing products. This failure to properly protect the intellectual property rights relating to these product candidates could have a material adverse effect on Elicio’s financial condition and results of operations.
Elicio has sought patent protection in the United States and
internationally related to the AMP platform technology as well as the mKRAS and universal adjuvant programs. However, Elicio does not own any issued patents covering clinical product candidates and the patent portfolio owned by Elicio currently
comprises only pending applications. The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that Elicio or its partners will be successful in protecting its product candidates by obtaining
and defending patents. These risks and uncertainties include the following:
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pending patent applications may not result in any patents being issued;
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patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, found to be
unenforceable, or otherwise may not provide barriers to entry or any competitive advantage;
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because of the extensive time required for development, testing and regulatory review of a potential product, it is possible
that before a potential product can be commercialized, any related patent may expire, or remain in existence for only a short period following commercialization, reducing or eliminating any advantage of the patent;
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Elicio’s competitors, many of which have substantially greater resources than it or its partners do, and many of which have
made significant investments in competing technologies, may seek, or may already have sought or obtained, patents that will limit, interfere with, or eliminate Elicio’s ability to make, use, and sell its potential products;
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there may be significant pressure on the U.S. government and other international governmental bodies to limit the scope of
patent protection both inside and outside the United States for disease treatments that prove successful as a matter of public policy regarding worldwide health concerns;
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countries other than the United States may have patent laws less favorable to patentees than those upheld by United States
courts, allowing foreign competitors a better opportunity to create, develop, and market competing products; and
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Elicio may be involved in lawsuits to protect or enforce its patents or the patents of its licensors, which could be
expensive, time-consuming and unsuccessful.
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In addition to patents, Elicio also relies on trade secrets and
proprietary know-how. Although it has taken steps to protect its trade secrets and unpatented know-how, including entering into confidentiality agreements with
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third parties, and confidential information and inventions agreements with
employees, consultants and advisors, third parties may still obtain this information or come upon this same or similar information independently. Elicio may become subject to claims that it or consultants, advisors or independent contractors
that it may engage to assist it in developing its product candidates have wrongfully or inadvertently disclosed to it or used trade secrets or other proprietary information of their former employers or their other clients.
Elicio may be forced to litigate to enforce
or defend its intellectual property rights, and/or the intellectual property rights of its licensors.
Elicio may be forced to litigate to enforce or defend its
intellectual property rights against infringement by competitors, and to protect its trade secrets against unauthorized use. In so doing, it may place its intellectual property at risk of being invalidated, rendered unenforceable, or limited or
narrowed in scope such that it may no longer be used to adequately prevent the manufacture and sale of competitive product. Further, an adverse result in any litigation or other proceedings before government agencies such as the United States
Patent and Trademark Office (USPTO), may place pending applications at risk of non-issuance. Further, interference proceedings, derivation proceedings, entitlement proceedings, ex parte reexamination, inter
partes reexamination, inter partes review, post-grant review, and opposition proceedings provoked by third parties or brought by the USPTO or any foreign patent authority may be used to
challenge the inventorship, ownership, claim scope, or validity of Elicio’s patent applications. Additionally, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that
some of Elicio’s confidential and proprietary information or trade secrets could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions, or other interim
proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of Elicio’s common stock. Such litigation or proceedings could substantially
increase Elicio’s operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. Elicio may not have sufficient financial or other resources to conduct such litigation
or proceedings adequately. Some of Elicio’s competitors may be able to sustain the costs of such litigation or proceedings more effectively than it can because of their greater financial resources and more mature and developed intellectual
property portfolios. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on Elicio’s ability to compete in the marketplace.
Elicio has rights in some intellectual
property that has been discovered through government funded programs and thus is subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry.
Elicio has rights in some intellectual property that has been
discovered through government funded programs and thus is subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry. Compliance with such regulations may limit its exclusive
rights, subject Elicio to expenditure of resources with respect to reporting requirements, and limit its ability to contract with non-U.S. manufacturers. Some of the intellectual property rights in-licensed to Elicio have been generated through
the use of U.S. government funding and are therefore subject to certain federal regulations. For example, all of the intellectual property rights licensed to it under its license agreement with the Massachusetts Institute of Technology (MIT)
have been generated using U.S. government funds. As a result, the U.S. government has certain rights to intellectual property embodied in Elicio’s current or future products pursuant to the Bayh-Dole Act of 1980. These U.S. government rights in
certain inventions developed under government-funded programs include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right to require
Elicio to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if the government determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government
action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). The U.S. government also has the right to
take title to these inventions if Elicio fails, or the applicable licensor fails, to disclose the invention to the government, elect title, and file an application to register the intellectual property within specified time limits. In addition,
the U.S. government may acquire title to these inventions in any country in which a patent application is not filed within specified time limits. Intellectual property generated under government funded programs is also subject to certain
reporting requirements, compliance with which may require Elicio, or the applicable licensor, to expend substantial resources. In addition, the U.S. government requires that any products embodying the subject invention or produced through the
use of the subject invention be manufactured substantially
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in the U.S. This requirement can be waived if the owner of the intellectual
property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that, under the circumstances,
domestic manufacture is not commercially feasible. This preference for U.S. manufacturing may limit Elicio’s ability to license the applicable patent rights on an exclusive basis under certain circumstances.
If Elicio enters into future arrangements involving government
funding, and it makes inventions as a result of such funding, its intellectual property rights to such discoveries may be subject to the applicable provisions of the Bayh-Dole Act. To the extent any of its current or future intellectual
property is generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply. Any exercise by the government of certain of its rights could harm Elicio’s competitive position, business, financial
condition, results of operations and prospects.
Elicio is substantially dependent on
patents it licenses from MIT, and if such licensed patent rights lack legal effect or if a dispute arises under such license agreement and its licensed rights are narrowed or this license is terminated, that could cause significant impairment
to its ability to develop and commercialize certain of its product candidates.
Elicio’s business is substantially dependent upon technology
licensed from MIT. Pursuant to Elicio’s license agreement with MIT, it was granted an exclusive, worldwide license, including the right to sublicense, under patents and patent applications owned by MIT related to the “Amphiphile” technology for
the diagnosis, treatment or prevention of diseases. The patent rights licensed from MIT cover products in development by Elicio for all of its current lead programs in tumor indications where mutant KRAS, rearranged ALK, or expression of human
papillomavirus proteins are a driver of disease, as well as programs using CpG as an adjuvant for immune activation. Therefore, Elicio’s ability to develop and commercialize several of its product candidates, including ELI-002 and ELI-004, is
substantially dependent on the legal effectiveness of the MIT patent rights licensed under this agreement and continuation of this agreement. MIT has the right to control the preparation, filing and prosecution of the patent applications, and
to maintain the patents, covering the patent rights Elicio licensed from MIT under this license agreement. Therefore, Elicio cannot be certain that these patents and patent applications will be prosecuted, maintained and enforced in a manner
consistent with the best interests of Elicio’s business. If MIT fails to maintain such patents, or loses rights to those patents or patent applications, the rights Elicio has licensed may be reduced or eliminated and its right to develop and
commercialize any of its products that are the subject of such licensed patent rights could be adversely affected, and it may not be able to prevent competitors from making, using or selling competing products. MIT also has the right to control
defense of any claims asserting the invalidity of these licensed patent rights and, even if Elicio is permitted to pursue such defense, it cannot ensure the cooperation of MIT. Elicio cannot be certain that MIT will allocate sufficient
resources or prioritize their or Elicio’s enforcement of such patent rights or their defense of such claims to protect Elicio’s interests in the licensed patent rights. Even if Elicio is not a party to these legal actions, an adverse outcome
could harm its business because it might prevent Elicio from continuing to license intellectual property that it may need to operate its business. In addition, although Elicio has the right to control enforcement of the licensed patents, it may
be adversely affected or prejudiced by actions or inactions of MIT and their counsel that took place prior to or after Elicio’s assuming control.
The license agreement with MIT is complex, and certain provisions
in this license agreement may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow or eliminate what Elicio believes to be the scope of its rights to the licensed
patent rights or increase what it believes to be its financial or other obligations under the license agreement, either of which could have a material adverse effect on its business, financial condition, results of operations and prospects.
If Elicio or its partners are sued for
infringing on the intellectual property rights of third parties, it could be costly and time-consuming, and an unfavorable outcome in any such litigation could have a material adverse effect on its business.
Elicio’s success also depends upon its ability and the ability of
any of its future collaborators to develop, manufacture, market and sell its product candidates without infringing on the proprietary rights of third parties. Numerous U.S. and foreign issued patents and pending patent applications, which are
owned by third parties, exist in the fields in which Elicio is developing products, some of which may be directed at claims that overlap with the
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subject matter of its intellectual property. Because patent applications can take
many years to issue, there may be currently pending applications, unknown to Elicio, which may later result in issued patents that its product candidates or proprietary technologies may infringe upon. Similarly, there may be issued patents
relevant to Elicio’s product candidates of which it is not aware.
In addition, third parties may sue Elicio for infringing on their
patents. Even if Elicio is successful in defending any claims of infringement, the defense of such claims may be costly and present a time-consuming distraction. In the event of a successful claim of infringement against Elicio, it may be
required to:
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pay substantial damages;
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stop using its technologies and methods;
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stop certain research and development efforts;
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develop non-infringing products or methods; and/or
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obtain one or more licenses from third parties.
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If required, Elicio cannot assure you that it will be able to
obtain such licenses on acceptable terms, or at all. If it is sued for infringement, it could encounter substantial delays in the development, manufacture and commercialization of its product candidates. Any litigation, whether to enforce its
patent rights or to defend against allegations that it infringed on third-party rights, could be costly, time-consuming, and may distract management from other important tasks.
As is commonplace in the biotechnology and pharmaceutical
industry, Elicio employs individuals who were previously employed at other biotechnology or pharmaceutical companies, including its competitors or potential competitors. To the extent Elicio’s employees are involved in research endeavors which
are similar to those which they were involved in at their former employers, it may be subject to claims that such employees and/or it has inadvertently or otherwise used or disclosed the alleged trade secrets or other proprietary information of
such former employers. Litigation may be necessary to defend against such claims, which could result in substantial costs, be a distraction to management and ultimately have a material adverse effect on Elicio, even if it is successful in
defending such claims.
The biotechnology and pharmaceutical
industries have experienced substantial litigation and other proceedings concerning intellectual property rights, and third parties may initiate legal proceedings alleging that Elicio is infringing, misappropriating, or otherwise violating
their intellectual property rights, the outcome of which could be uncertain and may prevent, delay or otherwise interfere with Elicio’s product discovery and development efforts.
Elicio’s commercial success depends upon its ability and the
ability of its collaborators and licensors to develop, manufacture, market, and sell ELI-002, ELI-004 and other Amphiphile immunotherapies. The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding
patents and other intellectual property rights as well as administrative proceedings for challenging patents, including interference, derivation, inter partes review, post grant review, and reexamination
proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. Elicio may be subject to and may in the future become party to, or threatened with, adversarial proceedings or litigation concerning
intellectual property rights with respect to its Amphiphile platform and any product candidates it may develop, including interference proceedings, post-grant review, inter partes review, and derivation
proceedings before the USPTO and similar proceedings in foreign jurisdictions such as oppositions before the European Patent Office (EPO). Numerous U.S. and foreign issued patents and pending patent applications that are owned by third parties
exist in the fields in which Elicio is developing its product candidates and infringement claims may be asserted against it or its partners based on existing patents or patents that may be granted in the future, regardless of their merit.
As the biotechnology and pharmaceutical industries expand and more
patents are issued, the risk increases that Elicio’s AMP platform and product candidates may give rise to claims of infringement of the patent rights of others. Moreover, it is not always clear to industry participants, including Elicio, which
patents cover various types of therapies, products or their methods of use or manufacture. As with many technology-based products, there may be third-party patent applications that, if issued, may be construed to cover components of Elicio’s
AMP platform and product candidates. There may also be third-party patents of which Elicio is currently unaware with claims to its technologies, compositions, methods of manufacture or methods of use.
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Because of the large number of patents issued and patent
applications filed in Elicio’s fields, third parties may allege they have patent rights encompassing its product candidates, technologies or methods. Third parties may assert that Elicio is employing their proprietary technology without
authorization and may file patent infringement claims or lawsuits against it, and if it is found to be infringing on any such third-party patents, it may be required to pay damages, cease commercialization of the infringing technology, or
obtain a license from such third party, which may not be available on commercially reasonable terms or at all.
Elicio’s ability to commercialize its product candidates in the
United States and abroad may be adversely affected if it cannot successfully defend infringement claims, or obtain a license on commercially reasonable terms to relevant third-party patents that cover its product candidates. Even if Elicio
believes third-party intellectual property claims are without merit, there can be no assurance that a court would find in its favor on questions of infringement, validity, enforceability, or priority. A court of competent jurisdiction could
hold that these third-party patents are valid and enforceable and have been infringed upon, which could materially and adversely affect Elicio’s ability to commercialize ELI-002 or any other product candidates and any other product candidates
or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, Elicio would need to overcome a presumption of validity. As this burden is a high one
requiring Elicio to present clear and convincing evidence as to the invalidity of any such U.S. patent claims, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If Elicio is found
to be infringing on a third party’s intellectual property rights, and it is unsuccessful in demonstrating that any such patents are invalid or unenforceable, it could be required to obtain a license from such third party to continue developing,
manufacturing, and marketing ELI-002 or any other product candidates and its technologies. However, Elicio may not be able to obtain any required license on commercially reasonable terms or at all. Even if Elicio were able to obtain such a
license, it could be non-exclusive, thereby giving its competitors and other third parties access to the same technologies licensed to it, and it could require Elicio to make substantial licensing and royalty payments. If Elicio is unable to
obtain a necessary license to a third-party patent on commercially reasonable terms, it may be unable to commercialize its AMP platform or product candidates or such commercialization efforts may be significantly delayed, which could in turn
significantly harm its business. Elicio also could be forced, including by court order, to cease developing, manufacturing, and commercializing the infringing technology or product candidates. In addition, Elicio could be found liable for
significant monetary damages, including treble damages and attorneys’ fees, if it is found to have willfully infringed on a patent or other intellectual property right. Claims that it has misappropriated the confidential information or trade
secrets of third parties could have a similar material adverse effect on its business, financial condition, results of operations, and prospects.
The defense of third-party claims of infringement,
misappropriation, or violation of intellectual property rights often involves substantial litigation expense and could be a substantial diversion of management and employee time and resources from Elicio’s business. Some third parties may be
able to sustain the costs of complex patent litigation more effectively than Elicio can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could
have a material adverse effect on Elicio’s ability to raise the funds necessary to continue its operations or could otherwise have a material adverse effect on its business, financial condition, results of operations and prospects. There could
also be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, this could have a substantial adverse effect on the
price of its common stock.
Obtaining and maintaining Elicio’s patent
protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and its patent protection could be reduced or eliminated for non-compliance with these
requirements.
Periodic maintenance fees, renewal fees, annuity fees, and various
other government fees on patents and applications are due to be paid to the USPTO and foreign patent agencies outside of the United States over the lifetime of Elicio’s owned or licensed patents and applications. For its in-licensed patents and
patent applications, Elicio generally relies on its licensors to pay these fees due to U.S. and non-U.S. patent agencies; however, it reimburses MIT for these fees as required by its license agreement with MIT. For Elicio’s owned patent
applications, it relies on its outside patent counsel in the United States and foreign countries to monitor these deadlines and to pay these fees when so instructed.
The USPTO and foreign patent agencies require compliance with
several procedural, documentary, fee payment, and other similar provisions, such as the requirement to disclose known prior art, during the patent application process. Elicio depends on its licensors to take the necessary action to comply with
these requirements with respect
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to its licensed intellectual property, and for its owned patent applications, it
engages counsel and other professionals to help it comply with these requirements. While certain inadvertent lapses can be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which
non-compliance can result in a partial or complete loss of patent rights in the relevant jurisdiction. Were a non-compliance event to occur, Elicio’s competitors might be able to enter the market with similar or identical products or
technology, which could have a material adverse effect on its business, financial condition, results of operations, and prospects.
Changes in patent law in the United States
and in non-U.S. jurisdictions could diminish the value of patents in general, thereby impairing Elicio’s ability to protect its technologies and product candidates.
As is the case with other biotech and pharmaceutical companies,
Elicio’s success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and are therefore costly, time-consuming
and inherently uncertain.
Changes in either the patent laws or interpretation of the patent
laws could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of Elicio’s issued patents. For example, in March 2013, under the Leahy-Smith America Invents Act (America Invents
Act) the United States transitioned from a “first to invent” to a “first-to-file” patent system. Under a “first-to-file” system, assuming that other requirements for patentability are met, the first inventor to file a patent application
generally will be entitled to a patent on an invention regardless of whether another inventor had made the invention earlier. A third party that filed a patent application in the USPTO after March 2013, but before Elicio could therefore be
awarded a patent covering an invention of Elicio’s even if Elicio had made the invention before it was made by such third party. This requires Elicio to be cognizant of the time from invention to filing of a patent application. Since patent
applications in the United States and most other countries are confidential for a period of time after filing or until issuance, Elicio cannot be certain that it or its licensors were the first to either file any patent application related to
its technologies or product candidates or invent any of the inventions claimed in its or its licensor’s patents or patent applications. The America Invents Act also includes a number of other significant changes to U.S. patent law, including
provisions that affect the way patent applications will be prosecuted, allowing third-party submission of prior art and establishing a new post-grant review system, including post-grant review, inter partes
review, and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially
provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may
attempt to use USPTO procedures to invalidate Elicio’s patent claims that would not have been invalidated if first challenged by the third party in a district court action. The ultimate impact of these changes is currently unclear as the USPTO
continues to promulgate new regulations and procedures in connection with the America Invents Act, and many of the substantive changes to patent law, including the “first-to-file” provisions, only became effective in March 2013. In addition,
the courts have yet to address many of these provisions and the applicability of the America Invents Act and new regulations to the specific patents discussed in this filing has not been determined and would need to be reviewed. Collectively,
these changes could increase the uncertainties and costs surrounding the prosecution of Elicio’s patent applications and the enforcement or defense of its issued patents.
In addition, recent U.S. Supreme Court rulings have narrowed the
scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to Elicio’s ability to obtain patents in the future, this
combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained. Depending on future actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing
patents could change in unpredictable ways that could weaken Elicio’s ability to obtain new patents or to enforce its existing patents and patents that it might obtain in the future.
Patent terms may be inadequate to protect
Elicio’s competitive position on its product candidates for an adequate amount of time.
Patents have a limited lifespan. The terms of individual patents
depend upon the legal term for patents in the countries in which they are granted. In most countries, including the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its
earliest non-provisional filing date in the applicable country. However, the actual protection afforded by a patent varies from country to country, and depends upon many factors, including the type of patent, the scope of its coverage, the
availability of regulatory-related
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extensions, the availability of legal remedies in a particular country and the
validity and enforceability of the patent. Various extensions including patent term extension (PTE) and patent term adjustment (PTA) may be available, but the lives of such extensions, and the protections they afford, are limited. Even if
patents covering Elicio’s product candidates are obtained, once the patent life has expired, Elicio may be open to competition from competitive products, including biosimilars and generics. Given the amount of time required for the development,
testing and regulatory review of new product candidates, patents protecting Elicio’s product candidates might expire before or shortly after Elicio or its partners commercialize those candidates. As a result, Elicio’s owned and licensed patent
portfolio may not provide Elicio with sufficient rights to exclude others from commercializing products similar or identical to Elicio’s.
If Elicio is unable to protect the
confidentiality of its trade secrets, its business and competitive position could be harmed.
In addition to seeking patents for its technologies and product
candidates, Elicio also relies on trade secret protection, as well as confidentiality agreements, non-disclosure agreements and invention assignment agreements with its employees, consultants and third parties, to protect its know-how and other
confidential and proprietary information, especially where it does not believe patent protection is appropriate or obtainable.
It is Elicio’s policy to require its employees, corporate
collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors, and other third parties to execute confidentiality agreements upon the commencement of employment or consulting relationships with it. These
agreements generally provide that all confidential information concerning Elicio’s business or financial affairs developed by or made known to an individual or entity during the course of that party’s relationship with Elicio is to be kept
confidential and not disclosed to third parties, except in certain specified circumstances. In the case of employees, the agreements provide that all inventions conceived by the individual, and that are related to Elicio’s current or planned
business or research and development or made during normal working hours, on Elicio’s premises or using Elicio’s equipment or proprietary information, are Elicio’s exclusive property. In the case of consultants and other third-party service
providers, the agreements provide Elicio with certain rights to all inventions arising from the services provided to it by those individuals or entities. However, Elicio cannot guarantee that it has entered into such agreements with each party
that may have or have had access to its trade secrets or proprietary technologies and processes. Additionally, the assignment of intellectual property rights may not be self-executing, or assignment agreements may be breached, and Elicio may be
forced to bring claims against third parties, or defend claims that they may bring against it, to determine the ownership of what Elicio regards as its intellectual property. Elicio may not be able to obtain adequate remedies for any breaches
of such agreements. Ultimately, enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the outcome is unpredictable.
In addition to contractual measures, Elicio tries to protect the
confidential nature of its proprietary information through other appropriate precautions, such as physical and technological security measures. However, trade secrets and know-how can be difficult to protect. These measures may not, for
example, in the case of misappropriation of a trade secret by an employee or third party with authorized access, provide adequate protection for Elicio’s proprietary information. Elicio’s security measures may not prevent an employee or
consultant from misappropriating its trade secrets and providing them to a competitor, and any recourse it might take against this type of misconduct may not provide an adequate remedy to protect its interests fully. In addition, Elicio’s trade
secrets may be independently developed by others in a manner that could prevent it from receiving legal recourse. If any of Elicio’s confidential or proprietary information, such as its trade secrets, were to be disclosed or misappropriated, or
if any of that information was independently developed by a competitor, its competitive position could be harmed.
In addition, courts inside and outside the United States are
sometimes less willing or unwilling to protect trade secrets. If Elicio chooses to go to court to stop a third party from using any of Elicio’s trade secrets, it may incur substantial costs. Even if Elicio is successful, these types of lawsuits
may consume significant amounts of its time and other resources. Any of the foregoing could have a material adverse effect on its business, financial condition, results of operations and prospects.
Third parties may assert that Elicio’s
employees, consultants, or advisors have wrongfully used or disclosed confidential information or misappropriated trade secrets.
As is common in the biotechnology and pharmaceutical industries,
Elicio employs individuals that are currently or were previously employed at universities, research institutions or other biotechnology or pharmaceutical companies, including Elicio’s competitors or potential competitors. Although Elicio tries
to ensure that its employees,
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consultants, and advisors do not use the proprietary information or know-how of
others in their work for it, Elicio may be subject to claims that it or these individuals have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any such
individual’s current or former employer. Elicio may then be involved in litigation proceedings to defend against these claims. If it fails in defending against any such claims, in addition to potentially paying monetary damages, it may lose
valuable intellectual property rights or personnel. Even if it is successful in defending against such claims, litigation could result in substantial costs and distract its technical and management personnel from their normal responsibilities.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and, if securities analysts or investors perceive these results to be negative, that perception could have a
substantial adverse effect on the price of Elicio’s common stock. Ultimately, any such litigation could substantially increase Elicio’s operating losses and reduce its resources available for development activities, and it may not have
sufficient financial or other resources to adequately engage in such litigation. For example, some of Elicio’s competitors may be able to sustain the costs of such litigation more effectively than it can because of their substantially greater
financial resources. In any case, uncertainties resulting from the initiation and continuation of intellectual property litigation or other intellectual property related proceedings could adversely affect Elicio’s ability to compete in the
marketplace.
Any trademarks Elicio may obtain may be
infringed or successfully challenged, resulting in harm to its business.
Elicio expects to rely on trademarks as one means to distinguish
any of its product candidates that are approved for marketing from the products of its competitors. However, Elicio’s trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on
other marks. Elicio may not be able to protect its rights to these trademarks and trade names, which it needs to build name recognition among potential partners or customers in its markets of interest. At times, competitors or other third
parties may adopt trade names or trademarks similar to Elicio’s, thereby impeding its ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims
brought by owners of other registered trademarks or trademarks that incorporate variations of Elicio’s registered or unregistered trademarks or trade names. Over the long term, if Elicio is unable to establish name recognition based on its
trademarks and trade names, then it may not be able to compete effectively and its business may be adversely affected. Elicio’s efforts to enforce or protect its proprietary rights related to trademarks, trade secrets, domain names, copyrights
or other intellectual property may be ineffective and could result in substantial costs and diversions of resources and could adversely affect Elicio’s business, financial condition, results of operations and growth prospects.
In addition, any proprietary name Elicio proposes to use with any
product candidate in the United States must be approved by the FDA, regardless of whether it have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation
of the potential for confusion with other product names. If the FDA objects to any of Elicio’s proposed proprietary product names, Elicio may be required to expend significant additional resources in an effort to identify a suitable proprietary
product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties, and be acceptable to the FDA.
Intellectual property rights do not necessarily
address all potential threats.
The degree of future protection afforded by Elicio’s intellectual
property rights is uncertain because intellectual property rights have limitations and may not adequately protect Elicio’s business or permit it to maintain its competitive advantage. For example:
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any of Elicio’s current and future product candidates, if approved, may eventually become commercially available in generic
or biosimilar product forms;
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others may be able to make immunotherapies that are similar to any of Elicio’s current and future product candidates or
utilize lymph node targeting technology but that are not covered by the claims of the patents that Elicio licenses or may own in the future;
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Elicio, or its licensors or current or future collaborators, might not have been the first to make the inventions covered by
the issued patent or pending patent application that it licenses or may own in the future, potentially resulting in the invalidation of such patents or refusal of such applications;
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Elicio, or its licensors or current or future collaborators, might not have been the first to file patent applications
covering certain of its or their inventions;
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Elicio, or its licensors or current or future collaborators, may fail to meet its obligations to the U.S. government
regarding any in-licensed patents and patent applications funded by U.S. government grants, leading to the loss or unenforceability of patent rights;
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others may independently develop similar or alternative technologies or duplicate any of Elicio’s technologies without
infringing on its owned or licensed intellectual property rights;
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it is possible that Elicio’s pending, owned or licensed patent applications or those that it may own or license in the future
will not lead to issued patents;
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it is possible that there are prior public disclosures that could invalidate Elicio’s owned or in-licensed patents, or parts
of its owned or in-licensed patents;
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it is possible that there are unpublished applications or patent applications maintained in secrecy that may later issue with
claims covering Elicio’s product candidates or technology similar to Elicio’s;
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it is possible that Elicio’s owned or in-licensed patents or patent applications omit individual(s) that should be listed as
inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable;
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issued patents that Elicio hold rights to may be held invalid, unenforceable, or narrowed in scope, including as a result of
legal challenges by its competitors;
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the claims of Elicio’s owned or in-licensed issued patents or patent applications, if and when issued, may not cover its
product candidates;
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the laws of foreign countries may not protect Elicio’s proprietary rights or the proprietary rights of its licensors or
current or future collaborators to the same extent as the laws of the United States;
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the inventors of Elicio’s owned or in-licensed patents or patent applications may become involved with competitors, develop
products or processes that design around its patents, or become hostile to it or the patents or patent applications on which they are named as inventors;
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Elicio’s competitors might conduct research and development activities in countries where it does not have patent rights and
then use the information learned from such activities to develop competitive products for sale in its major commercial markets;
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Elicio has engaged in scientific collaborations in the past and it intends to continue to do so in the future, and its
collaborators may develop adjacent or competing products that are outside the scope of its patents;
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Elicio may not develop additional proprietary technologies that are patentable;
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any product candidates Elicio develops may be covered by third-party patents or other exclusive rights;
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the patents of others may prohibit or otherwise harm Elicio’s business; or
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Elicio may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may
subsequently file a patent covering such intellectual property.
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Should any of these events occur, they could have a material
adverse effect on Elicio’s business, financial condition, results of operations, and prospects.
The FDA regulatory approval process is
lengthy, time-consuming, and inherently unpredictable, and Elicio may experience significant delays in the clinical development and regulatory approval, if any, of its product candidates.
The research, testing, manufacturing, labeling, approval, selling,
import, export, adverse event reporting, record keeping, advertising, promotion, and distribution of drug products, including biologics, are subject to extensive regulation by the FDA and other regulatory authorities in the United States.
Elicio is not permitted to market any biological product in the United States until it receives a biologics license from the FDA. It has not previously submitted a BLA to the FDA, or similar approval filings to comparable foreign authorities. A
BLA must include extensive nonclinical and clinical data and supporting information to establish that the product candidate is safe, pure, potent, and effective for each desired indication. The BLA must also include significant information
regarding the chemistry, manufacturing, and controls for the product, and the manufacturing facilities must complete a successful
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pre-license inspection. The FDA may also require a panel of experts, referred to
as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory Committee, although not binding, may have a significant impact on Elicio’s ability to obtain licensure of
the product candidates based on the completed clinical trials. Accordingly, the regulatory approval pathway for Elicio’s product candidates may be uncertain, complex, expensive, and lengthy, and approval may not be obtained.
Even if Elicio receives regulatory
approval of its product candidates, it will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and it may be subject to penalties if it fails to comply with
regulatory requirements.
If Elicio’s product candidates are approved, they will be subject
to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post- marketing studies, and submission of safety, efficacy, and other post-market information,
including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.
Manufacturers and manufacturers’ facilities must comply with
extensive FDA, and comparable foreign regulatory authority, requirements, including ensuring that quality control and manufacturing procedures conform to cGMP regulations. As such, Elicio and its contract manufacturers will be subject to
continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA, other marketing applications, and previous responses to inspection observations. Accordingly, Elicio and others with whom it works
must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control.
Any regulatory approvals that Elicio receives for its product
candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical
trials, and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS program as a condition of approval of Elicio’s product candidates, which could entail requirements for long-term patient
follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable
foreign regulatory authority approves Elicio’s product candidates, it will have to comply with requirements including submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with
cGMP and GCP for any clinical trials that it conducts post-approval.
The FDA strictly regulates marketing, labeling, advertising, and
promotion of products that are placed on the market. Drugs and biologics may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and
regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.
Failure to comply with regulatory requirements, may result in
revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other
potential consequences include, among other things:
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product
recalls;
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fines, warning letters or other enforcement-related letters or clinical holds on post-approval clinical trials;
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refusal of the FDA to approve pending BLAs or supplements to approved BLAs, or suspension or revocation of product approvals;
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product seizure or detention, or refusal to permit the import or export of products;
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injunctions or the imposition of civil or criminal penalties; and
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consent decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs; or mandated
modification of promotional materials and labeling and the issuance of corrective information.
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The policies of the FDA and of other regulatory authorities may
change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Elicio’s product candidates. Elicio cannot predict the likelihood, nature or extent of government regulation that may arise
from future legislation or administrative action, either in the United States or abroad. If Elicio is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Elicio is not able to
maintain regulatory compliance, Elicio may lose any marketing approval that it may have obtained and it may not achieve or sustain profitability.
Additional regulatory burdens and other risks
and uncertainties in foreign markets may limit Elicio’s growth.
Elicio’s future growth may depend, in part, on its ability to
develop and commercialize product candidates in foreign markets for which it may rely on strategic partnership with third parties. Elicio will not be permitted to market or promote any product candidate before it receives regulatory approval
from the applicable regulatory authority in a foreign market, and it may never receive such regulatory approval. To obtain separate regulatory approval in foreign countries, Elicio generally must comply with numerous and varying regulatory
requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing and distribution of a product candidate, and it cannot predict success in these jurisdictions. If
Elicio obtains approval of any of its potential future product candidates and ultimately commercialize any such product candidate in foreign markets, Elicio would be subject to risks and uncertainties, including the burden of complying with
complex and changing foreign regulatory, tax, accounting and legal requirements and the reduced protection of intellectual property rights in some foreign countries.
In addition, obtaining and maintaining regulatory approval of
Elicio’s product candidates in one jurisdiction does not guarantee that it will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a
negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing,
marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional
nonclinical studies or clinical trials as trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for
reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that Elicio intends to charge for its products is also subject to approval.
Obtaining foreign regulatory approvals and compliance with foreign
regulatory requirements could result in significant delays, difficulties and costs for Elicio and could delay or prevent the introduction of its products in certain countries. If Elicio fails to comply with the regulatory requirements in
international markets and/or to receive applicable marketing approvals, its target market will be reduced and its ability to realize the full market potential of its product candidates will be harmed.
Elicio’s relationships with health care
providers, physicians, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, anti-bribery and other health care laws and regulations, which could expose Elicio to criminal sanctions, civil penalties, contractual
damages, reputational harm, and diminished profits and future earnings.
Physicians, other health care providers and third-party payors
will play a primary role in the recommendation and prescription of ELI-002 or any other product candidates for which Elicio obtains marketing approval. Elicio’s future arrangements with third-party payors and customers may expose it to broadly
applicable fraud and abuse and other health care laws and regulations that may constrain the business or financial arrangements and relationships through which it markets, sells and distributes its product candidates for which it obtains
marketing approval. These laws and regulations include:
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the federal Anti-Kickback Statute;
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federal civil and criminal false claims laws and civil monetary penalties laws, including the federal False Claims Act;
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HIPAA, as amended by HITECH, and their respective implementing regulations, including the Final Omnibus Rule;
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the federal transparency requirements known as the federal Physician Payments Sunshine Act, created as part of the ACA; and
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analogous local, state and foreign laws and regulations.
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See Elicio’s discussion of these laws under “Description of Elicio’s Business—Government Regulation and Product Approval—FDA Regulation—Fraud and Abuse, Data Privacy and Security, and Transparency Laws and Regulations.”
Because of the breadth of these laws and the narrowness of the
statutory exceptions and safe harbors available, it is possible that some of Elicio’s business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these
laws. For example, the ACA, among other things, amends the intent requirement of the federal Anti-Kickback and criminal health care fraud statutes. As a result of such amendment, a person or entity no longer needs to have actual knowledge of
these statutes or specific intent to violate them in order to have committed a violation. Moreover, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
Efforts to ensure that Elicio’s business arrangements with third
parties will comply with applicable health care laws and regulations will involve substantial costs. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with
different compliance or reporting requirements increases the possibility that a health care company may run afoul of one or more of the requirements. If Elicio’s operations are found to be in violation of any applicable laws or any other
government regulations that apply to it, it may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines, individual imprisonment, disgorgement, contractual damages, reputational harm, exclusion from
participation in government health care programs, integrity obligations, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, private qui tam actions
brought by individual whistleblowers in the name of the government, refusal to allow Elicio to enter into supply contracts, including government contracts, additional reporting requirements and oversight if subject to a corporate integrity
agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of Elicio’s operations, any of which could adversely affect its ability to operate its business and its results of
operations.
Elicio intends to develop and implement a comprehensive corporate
compliance program prior to the commercialization of its product candidates. Although effective compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, these risks cannot be entirely eliminated.
Any action against Elicio for an alleged or suspected violation could cause Elicio to incur significant legal expenses and could divert its management’s attention from the operation of its business, even if its defense is successful. In
addition, achieving and sustaining compliance with applicable laws and regulations may be costly to Elicio in terms of money, time and resources. Moreover, federal, state or foreign laws or regulations are subject to change, and while Elicio,
its collaborators, manufacturers and/or service providers currently may be compliant, that could change due to changes in interpretation, prevailing industry standards or other reasons.
Health care and other reform legislation
may increase the difficulty and cost for Elicio and any collaborators it may have to obtain marketing approval of and commercialize its product candidates and affect the prices it, or they, may obtain.
All aspects of Elicio’s business, including research and
development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject to extensive legislation and regulation. Changes in applicable U.S. federal and state laws and agency regulation, as well as
foreign laws and regulations, could have a materially negative impact on Elicio’s business. In the United States and in some other jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the
health care system that could prevent or delay marketing approval of Elicio’s product candidates or any potential future product candidates of Elicio’s, restrict or regulate post-approval activities, or affect Elicio’s ability to profitably
sell any product candidates for which it obtains marketing approval. Increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject Elicio to more stringent
product labeling and post-marketing testing and other requirements. Congress also must reauthorize the FDA’s user fee programs every five years and
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often makes changes to those programs in addition to policy or procedural changes
that may be negotiated between the FDA and industry stakeholders as part of this periodic reauthorization process. Congress most recently reauthorized the user fee programs in September 2022 without any substantive policy changes.
Among policy makers and payors in the United States and elsewhere,
there is significant interest in promoting changes in health care systems with the stated goals of containing health care costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a focus of
these efforts and has been significantly affected by major legislative initiatives. In March 2010, Congress passed the ACA, which substantially changed the way health care is financed by both the government and private insurers, and
significantly impacts the U.S. pharmaceutical industry.
There remain judicial and Congressional challenges to certain
aspects of the ACA, and as a result certain sections of the ACA have not been fully implemented or effectively repealed. However, following several years of litigation in the federal courts, in June 2021, the U.S. Supreme Court upheld the ACA
when it dismissed a legal challenge to the law’s constitutionality. Further legislative and regulatory changes under the ACA remain possible, although the new federal administration under President Biden has signaled that it plans to build on
the ACA and expand the number of people who are eligible for health insurance subsidies under it. It is unknown what form any such changes or any law would take, and how or whether it may affect the pharmaceutical industry as a whole or
Elicio’s business in the future. Elicio expects that changes or additions to the ACA, the Medicare and Medicaid programs, and changes stemming from other health care reform measures, especially with regard to health care access, financing or
other legislation in individual states, could have a material adverse effect on the health care industry in the United States.
The uncertainty around the future of the ACA, and in particular
the impact to reimbursement levels, may lead to uncertainty or delay in the purchasing decisions of Elicio’s customers, which may in turn negatively impact Elicio’s product sales. If there are not adequate reimbursement levels, Elicio’s
business and results of operations could be adversely affected.
In addition, other legislative changes have been proposed and
adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013 and was extended by the Consolidated
Appropriations Act for 2023, and will remain in effect through 2032 unless additional Congressional action is taken.
In addition, the Drug Supply Chain Security Act enacted in 2013
imposed obligations on manufacturers of pharmaceutical products related to product tracking and tracing, and in February 2022, FDA released proposed regulations to amend the national standards for licensing of wholesale drug distributors by the
states; establish new minimum standards for state licensing third-party logistics providers; and create a federal system for licensure for use in the absence of a State program, each of which is mandated by the DSCSA. As another example, on
December 20, 2019, President Trump signed the Further Consolidated Appropriations Act for 2020 into law (P.L. 116-94) that includes a piece of bipartisan legislation called the CREATES Act. The CREATES Act aims to address the concern
articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the existence of a REMS for certain products, to deny generic and
biosimilar product developers access to samples of brand products. The CREATES Act establishes a private cause of action that permits a generic or biosimilar product developer to sue the brand manufacturer to compel it to furnish the necessary
samples on “commercially reasonable, market-based terms.” Whether and how generic and biosimilar product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain
highly uncertain and its potential effects on Elicio’s future commercial products are unknown. Other legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for
pharmaceutical products. Elicio is unsure whether additional legislative changes will be enacted, or whether the current regulations, guidance or interpretations will be changed, or whether such changes will have any impact on its business.
Additionally, there has been heightened governmental scrutiny in
the United States of pharmaceutical pricing practices considering the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation
designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. For example, state
legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical pricing, including
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price or patient reimbursement constraints, discounts, restrictions on certain
product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In December 2020, the U.S. Supreme Court held unanimously that federal law
does not preempt the states’ ability to regulate pharmaceutical benefit managers (PBMs) and other members of the health care and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states
in this area.
At the federal level, HHS has solicited feedback on various
measures intended to lower drug prices and reduce the out-of-pocket costs of drugs and has implemented others under its existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage plans the option to use
step therapy for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019.
Most recently, in August 2022, President Biden signed into the law
the Inflation Reduction Act of 2022 (IRA). Among other things, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. Starting in 2023, a
manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the product’s price increases faster than the rate of inflation. This calculation is made on a drug product by drug
product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D. Additionally, starting in payment year 2026, CMS will negotiate drug
prices annually for a select number of single source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected
by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.
Any additional federal or state health care reform measures could
limit the amounts that third-party payers will pay for future health care products and services, and, in turn, could significantly reduce the projected value of certain development projects and reduce Elicio’s profitability.
Elicio’s employees, principal investigators,
consultants, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
Elicio is exposed to the risk of fraud or other misconduct by its
employees, consultants, and commercial partners, and, its principal investigators. Misconduct by these parties could include intentional failures to comply with FDA regulations or the regulations applicable in the European Union and other
jurisdictions, provide accurate information to the FDA or other regulatory authorities, comply with health care fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately, or disclose
unauthorized activities to Elicio. In particular, sales, marketing, and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other
abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs, and other business arrangements. Such misconduct also could involve
the improper use of information obtained in the course of clinical trials or interactions with the FDA or other regulatory authorities, which could result in regulatory sanctions and cause serious harm to Elicio’s reputation. It is not always
possible to identify and deter employee misconduct, and the precautions Elicio takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Elicio from government
investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against Elicio, and it is not successful in defending itself or asserting its rights, those actions
could have a significant impact on its business, financial condition, results of operations, and prospects, including the imposition of significant fines or other sanctions.
Laws and regulations governing any
international operations Elicio may have in the future may preclude it from developing, manufacturing and selling certain product candidates outside of the United States and require it to develop and implement costly compliance programs.
Elicio is subject to numerous laws and regulations in each
jurisdiction outside the United States in which it operates. The creation, implementation and maintenance of international business practices compliance programs is costly and such programs are difficult to enforce, particularly where reliance
on third parties is required.
The Foreign Corrupt Practices Act (FCPA) prohibits any U.S.
individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or
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candidate for the purpose of influencing any act or decision of the foreign entity
in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain
books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. The
anti-bribery provisions of the FCPA are enforced primarily by the U.S. Department of Justice. The SEC is involved with enforcement of the books and records provisions of the FCPA.
Similarly, the U.K. Bribery Act 2010 has extra-territorial effect
for companies and individuals having a connection with the United Kingdom. The U.K. Bribery Act prohibits inducements both to public officials and private individuals and organizations. Compliance with the FCPA and the U.K. Bribery Act is
expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the
government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led
to FCPA enforcement actions.
Various laws, regulations and executive orders also restrict the
use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If Elicio
expands its business outside of the United States, it will be required to dedicate additional resources to comply with these laws, and these laws may preclude it from developing, manufacturing, or selling certain products and product candidates
outside of the United States, which could limit Elicio’s growth potential and increase its development costs. The failure to comply with laws governing international business practices may result in substantial penalties, including suspension
or debarment from government contracting. Violations of the FCPA can result in significant civil and criminal penalties. Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S. government until the
pending claims are resolved. A conviction under the FCPA can result in long-term disqualification as a government contractor. The termination of a government contract or relationship as a result of Elicio’s failure to satisfy any of its
obligations under laws governing international business practices could have a negative impact on its operations and harm its reputation and ability to procure government contracts. The SEC also may suspend or bar issuers from trading
securities on U.S. exchanges for violations of the FCPA’s accounting provisions.
Elicio is subject to stringent privacy laws,
information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies and contractual obligations could adversely affect its business.
Elicio and its current and potential collaborators may be subject
to federal, state and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and
regulations, including federal health information privacy laws (e.g., the Health Insurance Portability and Accountability Act (HIPAA) as amended by the Health Information Technology for Economic and
Clinical Health Act (HITECH), state data breach notification laws, state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission
Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to Elicio’s operations or the operations of its collaborators. In addition, Elicio may obtain health information from
third parties (including research institutions from which it obtains clinical trial data) that are subject to privacy and security requirements under HIPAA, as amended by HITECH, or other privacy and data security laws. Depending on the facts
and circumstances, Elicio could be subject to criminal penalties if it knowingly obtains, uses, or discloses protected health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. However,
determining whether protected health information has been handled in compliance with applicable privacy standards and its contractual obligations can be complex and may be subject to changing interpretation.
If Elicio is unable to properly protect the privacy and security
of protected health information or other personal, sensitive, or confidential information in its possession, Elicio could be found to have breached its contracts. Further, if Elicio fails to comply with applicable privacy laws, including
applicable HIPAA privacy and security standards, it could face significant administrative, civil and criminal penalties. Enforcement activity can also result in financial liability and reputational harm, and responses to such enforcement
activity can consume significant internal and outside resources. Furthermore, state attorneys general are authorized to bring civil actions seeking either injunctions or damages in response to violations that threaten the privacy of state
residents. In addition to the risks associated
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with enforcement activities and potential contractual liabilities, Elicio’s
ongoing efforts to comply with evolving laws and regulations at the federal and state level may be costly and require ongoing modifications to its policies, procedures and systems.
Many state laws govern the privacy and security of personal
information and data in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts. For example,
in 2018, California enacted the California Consumer Privacy Act (CCPA) which creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling
personal data of consumers or households. The CCPA requires covered companies to provide new disclosure to consumers about such companies’ data collection, use and sharing practices, provide such consumers new ways to opt-out of certain sales
or transfers of personal information, and provide consumers with additional causes of action. While there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, as currently written,
the CCPA may impact Elicio’s business activities. In addition, the California Privacy Rights Act (CPRA) was recently enacted to strengthen elements of the CCPA and became effective on January 1, 2023. A number of other states have considered
similar privacy proposals, with states like Virginia and Colorado enacting their own privacy laws. For example, the Virginia Consumer Data Protection Act became effective on January 1, 2023, and the Colorado Privacy Act is scheduled to come
into effect on July 1, 2023. These privacy laws may impact Elicio’s business activities and exemplify the vulnerability of its business to the evolving regulatory environment related to personal data.
In the European Union (EU), Elicio may be subject to the General
Data Protection Regulation (GDPR) which went into effect in May 2018 and which imposes obligations on companies that operate in Elicio’s industry with respect to the processing of personal data and the cross-border transfer of such data. The
GDPR applies to any company established in the European Economic Area (EEA) (which includes the EU Member States plus Iceland, Liechtenstein, and Norway) and to companies established outside the EEA that process personal data in connection with
the offering of goods or services to data subjects in the EEA or the monitoring of the behavior of data subjects in the EEA. The GDPR establishes stringent requirements applicable to the processing of personal data, including strict
requirements relating to the validity of consent of data subjects, expanded disclosures about how personal data is used, requirements to conduct data protection impact assessments for “high risk” processing, limitations on retention of personal
data, special provisions affording greater protection to and requiring additional compliance measures for “special categories of personal data” including health and genetic information of data subjects, mandatory data breach notification (in
certain circumstances), “privacy by design” requirements, and direct obligations on service providers acting as processors. The GDPR also prohibits the international transfer of personal data from the EEA to countries outside of the EEA unless
made to a country deemed to have adequate data privacy laws by the European Commission or a data transfer mechanism has been put in place. If Elicio’s or its partners’ or service providers’ privacy or data security measures fail to comply with
the GDPR requirements, Elicio may be subject to litigation, regulatory investigations, enforcement notices requiring it to change the way it uses personal data and/or fines of up to 20 million Euros or up to 4% of the total worldwide annual
turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill.
The GDPR may also impose additional compliance obligations
relating to the transfer of data between Elicio and its affiliates, collaborators, or other business partners. For example, on July 16, 2020, the Court of Justice of the European Union (CJEU), issued a landmark opinion in the case Maximilian Schrems vs. Facebook (Case C-311/18), called Schrems II. This decision (a) calls into question commonly relied upon data transfer mechanisms as between
the EU Member States and the United States (such as the Standard Contractual Clauses) and (b) invalidates the EU-U.S. Privacy Shield on which many companies had relied as an acceptable mechanism for transferring such data from the EU to the
United States. The CJEU is the highest court in Europe and the Schrems II decision heightens the burden on data importers to assess U.S. national security laws on their business and future actions of EU
data protection authorities are difficult to predict. Some customers or other service providers may respond to these evolving laws and regulations by asking Elicio to make certain privacy or data-related contractual commitments that Elicio is
unable or unwilling to make. This could lead to the loss of current or prospective customers or other business relationships.
Relatedly, following the United Kingdom’s withdrawal from the EU
(i.e., Brexit), and the expiry of the Brexit transition period, which ended on December 31, 2020, the EU GDPR has been implemented in the United Kingdom
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(as the UK GDPR). The UK GDPR sits alongside the UK Data Protection Act 2018 which
implements certain derogations in the EU GDPR into UK law. Under the UK GDPR, companies not established in the UK but who process personal data in relation to the offering of goods or services to individuals in the UK, or to monitor their
behavior will be subject to the UK GDPR – the requirements of which are (at this time) largely aligned with those under the EU GDPR and as such, may lead to similar compliance and operational costs with potential fines of up to £17.5 million or
4% of global turnover.
A pandemic, epidemic, or outbreak of an
infectious disease, such as the COVID-19 pandemic, may materially and adversely affect Elicio’s business and its financial results and could cause a disruption to the development or supply of ELI-002 or any other product candidates.
Public health crises such as pandemics or similar outbreaks could
adversely impact Elicio’s business. Notably, the COVID-19 pandemic continues to evolve. The extent to which COVID-19 impacts Elicio’s operations or those of its collaborators will depend on future developments, which are highly uncertain and
cannot be predicted with confidence, including the duration of the outbreak, new information that will emerge concerning the severity of the virus and the actions to contain it or treat its impact, among others.
The continued spread of COVID-19 globally could adversely impact
any preclinical or clinical trial operations in the United States and Europe, including Elicio’s ability to recruit and retain patients and principal investigators and site staff who, as health care providers, may have heightened exposure to
COVID-19 if an outbreak occurs in their geography. For example, similar to other biotechnology companies, Elicio has experienced, and may in the future experience, delays in initiating IND-enabling studies, delays in manufacturing, protocol
deviations, enrolling patients in clinical trials and dosing patients in clinical trials, as well as in activating trial sites. The COVID-19 pandemic may also result in the need to suspend enrollment in clinical studies, subject withdrawals,
postponement of planned clinical or nonclinical studies, redirection of site resources from studies, study modification, suspension, or termination, the introduction of remote study procedures and modified informed consent procedures, study
site changes, direct delivery of investigational products to patient homes requiring state licensing, study deviations or noncompliance, and changes or delays in site monitoring. The foregoing may require that Elicio consult with relevant
review and ethics committees, IRBs, and the FDA. The foregoing may also impact the integrity of Elicio’s study data. The effects of the COVID-19 pandemic may also increase the need for clinical trial patient monitoring and regulatory reporting
of adverse effects. The pandemic could further impact Elicio’s ability to interact with the FDA or other regulatory authorities, and may result in delays in the conduct of inspections or review of pending applications or submissions. For
example, the FDA may delay pre-approval inspections (PAIs). Although the FDA lifted restrictions relating to COVID-19 and affecting its inspection and other compliance operations in July 2022, the agency currently faces a significant backlog on
compliance monitoring and enforcement activities for both domestic and foreign manufacturers, which may affect the scheduling of necessary pre-approval inspections of manufacturing facilities for drug and biological product candidates.
In addition, the patient populations that ELI-002 or any other
product candidates target may be particularly susceptible to COVID-19, which may make it more difficult for Elicio to identify patients able to enroll in its current and future clinical trials and may impact the ability of enrolled patients to
complete any such trials. Any negative impact the COVID-19 pandemic has on patient enrollment or treatment or the execution of ELI-002 or any other product candidates could cause costly delays to clinical trial activities, which could adversely
affect Elicio’s ability to obtain regulatory approval for and to commercialize its product candidates, increase its operating expenses and have a material adverse effect on its financial results. Additionally, timely enrollment in planned
clinical trials is dependent upon clinical trial sites which could be adversely affected by global health matters, such as pandemics. The COVID-19 pandemic has also impacted, and may continue to impact, Elicio’s third-party suppliers and
manufacturers, including through the effects of facility closures, reductions in operating hours, staggered shifts and other social distancing efforts, labor shortages, decreased productivity and the unavailability of materials or components.
While Elicio maintains an inventory of materials used to conduct Elicio’s research and development activities, a prolonged pandemic could lead to shortages in the raw materials necessary to manufacture Elicio’s product candidates. Specifically,
Elicio’s IND process for ELI-002 experienced delays in part as a result of the adverse impacts of COVID-19 experienced by Elicio’s CMOs. If any of these third parties are adversely impacted by the COVID-19 pandemic or the restrictions resulting
from the outbreak, if they cannot obtain the necessary supplies, or if such third parties need to prioritize other products or customers over Elicio, including under the Defense Production Act, Elicio may experience additional delays or
disruptions in its supply chain, which could have
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a material and adverse impact on its business. CMOs may also need to implement
measures and changes, or deviate from typical requirements because of the COVID-19 pandemic that may otherwise adversely impact Elicio’s supply chains or the quality of the resulting products or supplies. Depending on the change, Elicio may
need to obtain FDA pre-approval or otherwise provide the FDA with a notification of the change.
The COVID-19 pandemic may additionally result in changes in laws
and regulations. By example, in March 2020, the U.S. Congress passed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) which includes various provisions regarding FDA drug shortage reporting requirements, as well as provisions
regarding supply chain security, such as risk management plan requirements, and the promotion of supply chain redundancy and domestic manufacturing. This and any future changes in law may require that Elicio changes its internal processes and
procedures to ensure continued compliance.
Even after the COVID-19 pandemic subsides, Elicio may continue to
experience an adverse impact to its business as a result of its global economic impact, including from increased inflation and the prospect that policy responses to inflation could delay economic recovery or lead to another recession.
Any of these factors, and other factors related to any such
disruptions that are unforeseen, could have a material adverse effect on Elicio’s business, financial condition, results of operation or prospects. Further, uncertainty around these and related issues could continue to adversely impact the
economies of the United States and other countries, which could impact Elicio’s ability to raise the necessary capital needed to develop and commercialize its product candidates.
Elicio’s future success depends on its
ability to retain its Chief Executive Officer and other key executives and to attract, retain, and motivate qualified personnel.
Elicio is highly dependent on Robert Connelly, its Chief Executive
Officer, as well as the other principal members of its management and scientific teams. Mr. Connelly and such other principal members are employed “at will,” meaning Elicio or they may terminate the employment relationship at any time. The loss
of the services of any of these persons could impede the achievement of Elicio’s research, development, and commercialization objectives.
Recruiting and retaining qualified scientific, clinical,
manufacturing, business development, general and administrative and sales and marketing personnel will also be critical to Elicio’s success. Elicio may not be able to attract and retain these personnel on acceptable terms given the competition
among numerous pharmaceutical and biotechnology companies for similar personnel. Elicio also experiences competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, Elicio relies on
consultants and advisors, including scientific and clinical advisors, to assist it in formulating its research and development and commercialization strategy. Elicio’s consultants and advisors, including its scientific co-founder, may be
employed by employers other than Elicio and may have commitments under consulting or advisory contracts with other entities that may limit their availability to Elicio. In addition, inflation has had, and Elicio expects that it will continue to
have, an impact on the costs that it incurs to attract and retain qualified personnel, and may make it more difficult for it to attract and retain such personnel. The inability to recruit, or loss of services of certain executives, key
employees, consultants, or advisors, may impede the progress of Elicio’s research, development, and commercialization objectives and have a material adverse effect on its business, financial condition, results of operations, and prospects.
If Elicio is unable to hire additional
qualified personnel, its ability to grow its business may be harmed.
Over time Elicio will need to hire additional qualified personnel
with expertise in drug development, product registration, clinical, preclinical and nonclinical research, quality compliance, government regulation, formulation and manufacturing, financial matters and sales and marketing. Elicio competes for
qualified individuals with numerous biopharmaceutical companies, universities and other research institutions. Competition for such individuals is intense, and Elicio’s search for such personnel may not be successful. Attracting and retaining
qualified personnel will be critical to Elicio’s success.
Elicio expects to expand its development,
regulatory, and future sales and marketing capabilities, and as a result, it may encounter difficulties in managing its growth, which could disrupt its operations.
As of April 13, 2023, Elicio had 24 full-time employees and, in
connection with the growth and advancement of its pipeline and becoming a public company, it expects to increase the number of its employees and the scope of its operations, particularly in the areas of product development, regulatory affairs,
and sales and marketing. To
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manage its anticipated future growth, Elicio must continue to implement and
improve its managerial, operational, and financial systems, expand its facilities, and continue to recruit and train additional qualified personnel. Due to its limited financial resources and the limited experience of its management team in
managing a company with such anticipated growth, Elicio may not be able to effectively manage the expected expansion of its operations or recruit and train additional qualified personnel. Moreover, the expected physical expansion of its
operations may lead to significant costs and may divert its management and business development resources. Any inability to manage growth could delay the execution of its business plans or disrupt its operations.
As a growing biotechnology company, Elicio is actively pursuing
new platforms and product candidates in many therapeutic areas and across a wide range of diseases. Successfully developing product candidates for and fully understanding the regulatory and manufacturing pathways to all of these therapeutic
areas and disease states requires a significant depth of talent, resources and corporate processes in order to allow simultaneous execution across multiple areas. Due to its limited resources, Elicio may not be able to effectively manage this
simultaneous execution and the expansion of its operations or recruit and train additional qualified personnel. This may result in weaknesses in its infrastructure, give rise to operational mistakes, legal or regulatory compliance failures,
loss of business opportunities, loss of employees and reduced productivity among remaining employees. The physical expansion of Elicio’s operations may lead to significant costs and may divert financial resources from other projects, such as
the development of its product candidates. If Elicio’s management is unable to effectively manage its expected development and expansion, its expenses may increase more than expected, its ability to generate or increase its revenue could be
reduced, and it may not be able to implement its business strategy. Elicio’s future financial performance and its ability to compete effectively and commercialize its product candidates, if approved, will depend in part on its ability to
effectively manage the future development and expansion of its company.
Elicio’s internal computer systems, or those
of its vendors, collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of its product development programs, compromise sensitive information related to its business
or prevent it from accessing critical information, potentially exposing it to liability or otherwise adversely affecting its business.
Elicio’s internal computer systems and those of its current and
any future third-party vendors, collaborators and other contractors or consultants are vulnerable to damage, interruption or data theft from computer viruses, computer hackers, malicious code, employee theft or misuse, ransomware, social
engineering (including phishing attacks), denial-of-service attacks, sophisticated nation-state and nation-state-supported actors, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.
Cybersecurity incidents, which may not be immediately or ever detected, are increasing in frequency and evolving in nature. Additionally, due to geopolitical tensions related to Russia’s invasion of Ukraine, the risk of cyber-attacks may be
elevated.
While Elicio seeks to protect its information technology systems
from system failure, accident and security breach, if such an event were to occur and cause interruptions in its operations, it could result in a disruption of Elicio’s development programs and its business operations, whether due to a loss of
its trade secrets or other proprietary information or other disruptions. For example, the loss of clinical trial data from future clinical trials could result in delays in Elicio’s regulatory approval efforts and significantly increase its
costs to recover or reproduce the data. If Elicio were to experience a significant cybersecurity breach of its information systems or data, the costs associated with the investigation, remediation and potential notification of the breach to
counterparties and data subjects could be material. In addition, Elicio’s remediation efforts may not be successful. If it does not allocate and effectively manage the resources necessary to build and sustain the proper technology and
cybersecurity infrastructure, it could suffer significant business disruption, including transaction errors, supply chain or manufacturing interruptions, processing inefficiencies, data loss or the loss of or damage to intellectual property or
other proprietary information. In addition, in response to the ongoing COVID-19 pandemic, a majority of Elicio’s workforce began to work remotely, which has continued and is now considered its normal business. This could increase Elicio’s cyber
security risk, create data accessibility concerns, and make Elicio more susceptible to communication disruption.
To the extent that any disruption or security breach were to
result in a loss of, or damage to, Elicio’s or its third-party vendors’, collaborators’ or other contractors’ or consultants’ data or applications, or inappropriate disclosure of confidential or proprietary information, Elicio could incur
liability including litigation exposure, penalties and fines, Elicio could become the subject of regulatory actions or investigations, its competitive position could be harmed and the further development and commercialization of its product
candidates could be delayed. Any of the above could have a material adverse effect on Elicio’s business, financial condition, results of operations or
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prospects. While Elicio maintains cyber-liability insurance (covering security and
privacy matters), such insurance may not be adequate to cover any losses experienced as a result of a cybersecurity incident.
Unfavorable global economic conditions could
adversely affect Elicio’s business, financial condition or results of operations.
Elicio’s results of operations could be adversely affected by
general conditions in the global economy and in the global financial markets. For example, in 2008, the global financial crisis caused extreme volatility and disruptions in the capital and credit markets and the current COVID-19 pandemic has
caused significant volatility and uncertainty in U.S. and international markets. See “Risks Related to Employee and Operations Matters, Managing Growth and Information Technology— A pandemic, epidemic, or outbreak of an infectious disease, such
as the COVID-19 pandemic, may materially and adversely affect Elicio’s business and its financial results and could cause a disruption to the development or
supply of ELI-002 or any other product candidates.” A severe or prolonged economic downturn, or additional global financial crises, could result in a variety of risks to Elicio’s business, including weakened demand for its product candidates,
if approved, or its ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain Elicio’s suppliers, possibly resulting in supply disruption. Any of the foregoing could harm
Elicio’s business and it cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact its business.
U.S. federal income tax reform could adversely
affect Elicio’s business and financial condition.
The rules dealing with U.S. federal, state, and local income
taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely
affect Elicio or holders of its common stock. In recent years, many such changes have been made and changes are likely to continue to occur in the future. For example, on March 27, 2020, former President Trump signed into law the CARES Act
which included certain changes in tax law intended to stimulate the U.S. economy in light of the COVID-19 coronavirus outbreak, including temporary beneficial changes to the treatment of net operating losses, interest deductibility limitations
and payroll tax matters. Additionally, on December 22, 2017, former President Trump signed into law the Tax Cuts and Jobs Act of 2017 (TCJA), which significantly reformed the Code. The TCJA included significant changes to corporate and
individual taxation, some of which could adversely impact an investment in Elicio’s common stock. Under the TCJA, in general, NOLs generated in taxable years beginning after December 31, 2017 may offset no more than 80 percent of such year’s
taxable income and there is no ability for such NOLs to be carried back to a prior taxable year. The CARES Act modifies the TCJA with respect to the TCJA’s limitation on the deduction of NOLs and provides that NOLs arising in taxable years
beginning after December 31, 2017 and before January 1, 2021, may be carried back to each of the five taxable years preceding the tax year of such loss, but NOLs arising in taxable years beginning after December 31, 2020 may not be carried
back. In addition, the CARES Act eliminates the limitation on the deduction of NOLs to 80 percent of current year taxable income for taxable years beginning before January 1, 2021. As a result of such limitation, Elicio may be required to pay
federal income tax in some future year notwithstanding that it had a net loss for all years in the aggregate. Future changes in tax laws could have a material adverse effect on Elicio’s business, cash flow, financial condition or results of
operations. Elicio urges investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in Elicio’s common stock.
Elicio faces risks associated with increased
political uncertainty.
The recent invasion of Ukraine by Russia and the sanctions, bans
and other measures taken by governments, organizations and companies against Russia and certain Russian citizens in response thereto has increased the political uncertainty in Europe and has strained the relations between Russia and a
significant number of governments, including the U.S. The duration and outcome of this conflict, any retaliatory actions taken by Russia and the impact on regional or global economies is unknown, but could have a material adverse effect on
Elicio’s business, financial condition and results of its operations.
In determining whether you should vote approve the proposals
contained in this proxy statement/prospectus/information statement, you should carefully read the following risk factors in addition to the risks described above.
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The combined company will need to raise
additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all.
The combined company will require substantial additional funds to
conduct the costly and time-consuming clinical efficacy trials necessary to pursue regulatory approval of each potential product candidate and to continue the development of ELI-002 and Elicio’s other product candidates and future product
candidates. The combined company’s future capital requirements will depend upon a number of factors, including: the number and timing of future product candidates in the pipeline; progress with and results from preclinical testing and clinical
trials; the ability to manufacture sufficient drug supplies to complete preclinical and clinical trials; the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims;
and the time and costs involved in obtaining regulatory approvals and favorable reimbursement or formulary acceptance. Raising additional capital may be costly or difficult to obtain and could significantly dilute stockholders’ ownership
interests or inhibit the combined company’s ability to achieve its business objectives. If the combined company raises additional funds through public or private equity offerings, the terms of these securities may include liquidation or other
preferences that adversely the rights of its common stockholders. Further, to the extent that the combined company raises additional capital through the sale of common stock or securities convertible or exchangeable into common stock, its
stockholder’s ownership interest in the combined company will be diluted. In addition, any debt financing may subject the combined company to fixed payment obligations and covenants limiting or restricting its ability to take specific actions,
such as incurring additional debt, making capital expenditures or declaring dividends. If the combined company raises additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing
arrangements with third parties, the combined company may have to relinquish certain valuable intellectual property or other rights to its product candidates, technologies, future revenue streams or research programs or grant licenses on terms
that may not be favorable to it. Even if the combined company were to obtain sufficient funding, there can be no assurance that it will be available on terms acceptable to the combined company or its stockholders.
The market price of the combined company’s
common stock is expected to be volatile, and the market price of the common stock may drop following the Merger.
The market price of the combined company’s common stock following
the Merger could be subject to significant fluctuations. Market prices for securities of early-stage pharmaceutical, biotechnology and other life sciences companies have historically been particularly volatile. Some of the factors that may
cause the market price of the combined company’s common stock to fluctuate include:
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the ability of the combined company to obtain regulatory approvals for its product candidates, and delays or failures to
obtain such approvals;
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failure of any of the combined company’s product candidates, if approved, to achieve commercial success;
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failure by the combined company to maintain its existing third-party license and supply agreements;
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failure by the combined company or its licensors to prosecute, maintain, or enforce its intellectual property rights;
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changes in laws or regulations applicable to the combined company’s product candidates;
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any inability to obtain adequate supply of the combined company’s product candidates or the inability to do so at acceptable
prices;
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adverse regulatory authority decisions;
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introduction of new products, services or technologies by the combined company’s competitors;
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failure to meet or exceed financial and development projections the combined company may provide to the public;
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failure to meet or exceed the financial and development projections of the investment community;
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the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
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announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by the combined
company or its competitors;
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disputes or other developments relating to proprietary rights, including patents, litigation matters, and the combined
company’s ability to obtain patent protection for its technologies;
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additions or departures of key personnel;
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significant lawsuits, including patent or stockholder litigation;
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if securities or industry analysts do not publish research or reports about the combined company’s business, or if they issue
an adverse or misleading opinion regarding its business and stock;
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changes in the market valuations of similar companies;
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general market or macroeconomic conditions;
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sales of its common stock by the combined company or its stockholders in the future;
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trading volume of the combined company’s common stock;
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failure to maintain compliance with the listing requirements of The Nasdaq Global Market;
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announcements by commercial partners or competitors of new commercial products, clinical progress or the lack thereof,
significant contracts, commercial relationships or capital commitments;
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adverse publicity generally, including with respect to other products and potential products in such markets;
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the introduction of technological innovations or new therapies that compete with potential products of the combined company;
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changes in the structure of health care payment systems; and
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period-to-period fluctuations in the combined company’s financial results.
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Moreover, the stock markets in general have experienced
substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of the combined company’s common stock.
In the past, following periods of volatility in the market price
of a company’s securities, stockholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources,
which could significantly harm the combined company’s profitability and reputation.
Additionally, a decrease in the stock price of the combined
company may cause the combined company’s common stock to no longer satisfy the continued listing standards of Nasdaq. If the combined company is not able to maintain the requirements for listing on Nasdaq, it could be delisted, which could have
a materially adverse effect on its ability to raise additional funds as well as the price and liquidity of its common stock.
The combined company will incur costs and
demands upon management as a result of complying with the laws, rules and regulations affecting public companies.
The combined company will incur significant legal, accounting and
other expenses that Elicio did not incur as a private company, including costs associated with public company reporting requirements. The combined company will also incur costs associated with corporate governance requirements, including
requirements under the laws, rules and regulations of the SEC as well as the Nasdaq rules. These laws, rules and regulations are expected to increase the combined company’s legal and financial compliance costs and to make some activities more
time consuming and costly. For example, the combined company’s management team will consist of the executive officers of Elicio prior to the Merger, some of whom have not previously managed and operated a public company. These executive
officers and other personnel will need to devote substantial time to gaining expertise regarding operations as a public company and compliance with applicable laws and regulations. These laws, rules and regulations also may make it difficult
and expensive for the combined company to obtain directors’ and officers’ liability insurance. As a result, it may be more difficult for the combined company to attract and retain qualified individuals to serve on the combined company’s board
of directors or as executive officers of the combined company, which may adversely affect investor confidence in the combined company and could cause the combined company’s business or stock price to suffer.
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Anti-takeover provisions in the combined
company’s charter documents and under Delaware law could make an acquisition of the combined company more difficult and may prevent attempts by the combined company stockholders to replace or remove the combined company management.
Provisions in the combined company’s certificate of incorporation
and bylaws may delay or prevent an acquisition or a change in management. In addition, because the combined company will be incorporated in Delaware, it is governed by the provisions of Section 203 of the DGCL, which prohibits stockholders
owning in excess of 15% of the outstanding combined company voting stock from merging or combining with the combined company. Although Angion and Elicio believe these provisions collectively will provide for an opportunity to receive higher
bids by requiring potential acquirors to negotiate with the combined company’s board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any
attempts by the combined company’s stockholders to replace or remove then current management by making it more difficult for stockholders to replace members of the board of directors, which is responsible for appointing the members of
management.
The amended and restated certificate of
incorporation of the combined company will provide that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between the combined company and its stockholders, which could limit its stockholders’
ability to obtain a favorable judicial forum for disputes with the combined company or its directors, officers or other employees, and could make it more costly for stockholders to bring a claim against the combined company.
The amended and restated certificate of incorporation and amended
and restated bylaws of the combined company will be the amended and restated certificate of incorporation and amended and restated bylaws of Angion, which provide, among other things, that that the Court of Chancery of the State of Delaware
(or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware or other state courts of the State of Delaware) generally will be the exclusive forum for any derivative action or
proceeding brought on the combined company’s behalf, any action asserting a claim of breach of fiduciary duty, any action asserting a claim against the combined company arising pursuant to the DGCL, the combined company’s amended and restated
certificate of incorporation or the combined company’s amended and restated bylaws, or any action asserting a claim against the combined company that is governed by the internal affairs doctrine; provided that, the exclusive forum provision
will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery of the
State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware.
To prevent having to litigate claims in multiple jurisdictions and
the threat of inconsistent or contrary rulings by different courts, among other considerations, the amended and restated certificate of incorporation and the amended and restated bylaws of the combined company will further provide that the
federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. However, Section 22 of the Securities Act creates concurrent
jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims, and investors cannot waive compliance with the federal laws and rules and
regulations thereunder. While the Delaware courts have determined that such choice of forum provisions are facially valid and several state trial courts have enforced such provisions and required that suits asserting Securities Act claims be
filed in federal court, there is no guarantee that courts of appeal will affirm the enforceability of such provisions and a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum
provisions. In such instance, the combined company would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of its amended and restated certificate of incorporation and amended and restated bylaws.
This may require significant additional costs associated with resolving such action in other jurisdictions and there is uncertainty that the provision would be enforced by a court in those other jurisdictions. If a court were to find either
exclusive forum provision in the combined company’s amended and restated certificate of incorporation or amended and restated bylaws to be inapplicable or unenforceable in an action, the combined company may incur further significant additional
costs associated with litigating Securities Act claims in state court, or both state and federal court, which could seriously harm its business, financial condition, results of operations, and prospects. This exclusive forum provision may make
it more expensive for stockholders to bring a claim than if the stockholders were permitted to select another jurisdiction and may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the
combined company or its directors, officers or other employees or stockholders, which may discourage such lawsuits against the combined company and its directors, officers and other
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employees and stockholders. Alternatively, if a court were to find the choice of
forum provision contained in the combined company’s amended and restated certificate of incorporation or amended and restated bylaws to be inapplicable or unenforceable in an action, the combined company may incur additional costs associated
with resolving such action in other jurisdictions, which could materially and adversely affect its business, financial condition and results of operations.
Angion and Elicio do not anticipate that the
combined company will pay any cash dividends in the foreseeable future.
The current expectation is that the combined company will retain
its future earnings, if any, to fund the development and growth of the combined company’s business. As a result, capital appreciation, if any, of the common stock of the combined company will be its stockholders’ sole source of gain, if any,
for the foreseeable future.
An active trading market for the combined
company’s common stock may not develop and its stockholders may not be able to resell their shares of common stock for a profit, if at all.
Prior to the Merger, there had been no public market for Elicio’s
common stock. An active trading market for the combined company’s shares of common stock may never develop or be sustained. If an active market for its common stock does not develop or is not sustained, it may be difficult for its stockholders
to sell their shares at an attractive price or at all.
Future sales of shares by existing stockholders
could cause the combined company’s stock price to decline.
If existing stockholders of Angion and Elicio sell, or indicate an
intention to sell, substantial amounts of the combined company’s common stock in the public market after legal restrictions on resale discussed in this proxy statement/prospectus/information statement lapse, the trading price of the common
stock of the combined company could decline. Neither Angion nor Elicio is able to predict the effect that sales may have on the prevailing market price of the combined company’s common stock.
If equity research analysts do not publish
research or reports, or publish unfavorable research or reports, about the combined company, its business or its market, its stock price and trading volume could decline.
The trading market for the combined company’s common stock will be
influenced by the research and reports that equity research analysts publish about it and its business. Equity research analysts may elect not to provide research coverage of the combined company’s common stock after the completion of the
Merger, and such lack of research coverage may adversely affect the market price of its common stock. In the event it does have equity research analyst coverage, the combined company will not have any control over the analysts, or the content
and opinions included in their reports. The price of the combined company’s common stock could decline if one or more equity research analysts downgrade its stock or issue other unfavorable commentary or research. If one or more equity research
analysts ceases coverage of the combined company or fails to publish reports on it regularly, demand for its common stock could decrease, which in turn could cause its stock price or trading volume to decline.
The pro forma condensed combined financial
statements included in this proxy statement/prospectus/information statement are presented for illustrative purposes only and may not be an indication of the combined company's financial condition or results of operations following the
completion of the Merger.
The pro forma condensed combined financial statements contained in
this proxy statement/prospectus/information statement are presented for illustrative purposes only and may not be an indication of the combined company's financial condition or results of operations following the Merger for several reasons. The
pro forma condensed combined financial statements have been derived from the historical audited financial statements of Angion and Elicio and certain adjustments and assumptions have been made regarding the combined company after giving effect
to the Merger. The information upon which these adjustments and assumptions have been made is preliminary, and these kinds of adjustments and assumptions are difficult to make with accuracy. Moreover, the pro forma condensed combined financial
statements do not reflect all costs that are expected to be incurred by the combined company in connection with the Merger. For example, the impact of any incremental costs incurred in integrating the two companies is not reflected in the pro
forma condensed combined financial statements. As a result, the actual financial condition of the combined company following the Merger may not be consistent with, or evident from, these pro forma condensed combined financial statements. The
assumptions used in preparing the pro forma
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condensed combined financial statements may not prove to be accurate, and other
factors may affect the combined company's financial condition following the Merger. For more information, please see the section titled “Unaudited Pro Forma Condensed Combined Financial Statements” in
this proxy statement/prospectus/information statement.
If the combined company fails to maintain
proper and effective internal controls, its ability to produce accurate financial statements on a timely basis could be impaired.
The combined company will be subject to the reporting requirements
of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of Nasdaq. The Sarbanes-Oxley Act requires, among other things, that the combined company maintain effective disclosure controls and procedures and internal control over
financial reporting. The combined company must perform system and process evaluation and testing of its internal control over financial reporting to allow management to report on the effectiveness of its internal controls over financial
reporting in its Annual Report on Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act. As a private company, Elicio has never been required to test its internal controls within a specified period. This will
require that the combined company incur substantial professional fees and internal costs to expand its accounting and finance functions and that it expends significant management efforts. The combined company may experience difficulty in
meeting these reporting requirements in a timely manner.
The combined company may discover weaknesses in its system of
internal financial and accounting controls and procedures that could result in a material misstatement of its financial statements. The combined company’s internal control over financial reporting will not prevent or detect all errors and all
fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.
If the combined company is not able to comply with the
requirements of Section 404 of the Sarbanes-Oxley Act, or if it is unable to maintain proper and effective internal controls, the combined company may not be able to produce timely and accurate financial statements. If that were to happen, the
market price of its common stock could decline and it could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.
If the combined company fails to attract and
retain management and other key personnel, it may be unable to continue to successfully develop or commercialize its product candidates or otherwise implement its business plan.
The combined company’s ability to compete in the highly
competitive pharmaceuticals industry depends on its ability to attract and retain highly qualified managerial, scientific, medical, legal, sales and marketing and other personnel. The combined company will be highly dependent on its management
and scientific personnel. The loss of the services of any of these individuals could impede, delay, or prevent the successful development of the combined company’s product pipeline, completion of its planned clinical trials, commercialization
of its product candidates or in-licensing or acquisition of new assets and could impact negatively its ability to implement successfully its business plan. If the combined company loses the services of any of these individuals, it might not be
able to find suitable replacements on a timely basis or at all, and its business could be harmed as a result. The combined company might not be able to attract or retain qualified management and other key personnel in the future due to the
intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses.
The combined company is expected to take
advantage of reduced disclosure and governance requirements applicable to smaller reporting companies and emerging growth companies, which could result in its common stock being less attractive to investors.
Following the Merger, the combined company is expected to have a
public float of less than $250 million and therefore will qualify as a smaller reporting company under the rules of the SEC. As a smaller reporting company, the combined company will be able to take advantage of reduced disclosure requirements,
such as simplified executive compensation disclosures and reduced financial statement disclosure requirements in its SEC filings. Decreased disclosures in the combined company’s SEC filings due to its status as a smaller reporting company may
make it harder for investors to analyze its results of operations and financial prospects. Angion and Elicio cannot predict if investors will find the combined company’s common stock less attractive if it relies on these exemptions. If some
investors find its common stock less attractive as a result, there may be a less active trading market for its common stock and its stock price may be more volatile. The combined company may take advantage of the reporting
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exemptions applicable to a smaller reporting company until it is no longer a
smaller reporting company, which status would end once it has a public float greater than $250 million. In that event, the combined company could still be a smaller reporting company if its annual revenues were below $100 million and it has a
public float of less than $700 million.
Following the Merger, the combined company is expected to be an
emerging growth company (EGC), as defined in the Jumpstart Our Business Startups Act of 2012, as amended. For as long as the combined company continues to be an EGC, it may take advantage of exemptions from various reporting requirements that
are applicable to other public companies that are not EGCs, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive
compensation in this proxy statement/prospectus/information statement and its periodic reports and proxy statements and exemptions from the requirements of holding nonbinding advisory votes on executive compensation and stockholder approval of
any golden parachute payments not previously approved. The combined company may remain an EGC or until the earlier of (a) December 31, 2026, (b) the last day of the fiscal year in which the combined company has total annual gross revenue of at
least $1.235 billion or more, (c) the date the combined company is deemed to be a large accelerated filer, which requires the market value of its common stock that is held by non-affiliates to exceed $700.0 million as of the prior June 30th,
and (d) the date on which the combined company has issued more than $1.0 billion in non-convertible debt during the prior three-year period.
Changes in tax laws may materially
adversely affect the combined company’s business, prospects, financial condition and operating results.
New tax laws, statutes, rules, regulations or ordinances could be
enacted at any time, which could adversely affect the combined company’s business, prospects, financial condition and operating results. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed,
modified or applied adversely to the combined company. For example, the Tax Act, the CARES Act, and the IRA enacted many significant changes to the U.S. tax laws. Future guidance from the Internal Revenue Service and other tax authorities with
respect to such legislation may affect the combined company, and certain aspects of such legislation could be repealed or modified in future legislation. Such tax law changes could have a material adverse impact on the combined company. In
addition, it is uncertain if and to what extent various states will conform to newly enacted federal tax legislation. While it is too early to assess the overall impact of these changes, as these and other tax laws and related regulations are
revised, enacted, and implemented, the combined company’s financial condition, results of operations, and cash flows could be materially adversely impacted.
The combined company’s ability to use net
operating loss (NOL) carryforwards and other tax attributes may be limited, including as a result of the Merger.
Each of Angion and Elicio has incurred losses during its history,
and the combined company does not expect to become profitable in the near future and may never achieve profitability. To the extent that the combined company continues to generate taxable losses, unused losses will carry forward to offset
future taxable income, if any, until such unused losses expire, if at all. As of December 31, 2022, Angion had U.S. federal NOL carryforwards and state NOL carryforwards of $133.5 million and $108.0 million, respectively, and Elicio had U.S.
federal NOL carryforwards and state NOL carryforwards of approximately $71.7 million and $65.0 million, respectively. Under current law, U.S. federal NOL carryforwards generated in taxable periods beginning after December 31, 2017, may be
carried forward indefinitely, but the deductibility of such NOL carryforwards is limited to 80% of taxable income. It is uncertain if and to what extent various states will conform to federal law. In addition, under Sections 382 and 383 of the
Code, federal NOL carryforwards and other tax attributes may become subject to an annual limitation in the event of certain cumulative changes in ownership. An “ownership change” pursuant to Section 382 of the Code generally occurs if one or
more stockholders or groups of stockholders who own at least 5% of a company’s stock increase their ownership by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. The combined company’s
ability to utilize its NOL carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including potential changes in connection with the Merger or other
transactions. Similar rules may apply under state tax laws. If the combined company earns taxable income, such limitations could result in increased future income tax liability to the combined company, and the combined company’s future cash
flows could be adversely affected.
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This proxy statement/prospectus/information statement contain
forward-looking statements. These forward-looking statements are based on current expectations and beliefs and involve numerous risks and uncertainties that could cause actual results to differ materially from expectations. These
forward-looking statements should not be relied upon as predictions of future events and neither Angion nor Elicio can assure you that the events or circumstances reflected in these statements will be achieved or will occur. You can identify
forward-looking statements by the use of forward-looking terminology including “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “pro forma,” “should,” “would”
or the negative of these words and phrases or other variations of these words and phrases or comparable terminology. For example, forward-looking statements include, but are not limited to statements about:
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the strategies, prospects, plans, expectations and objectives of management of Angion or Elicio for future operations of the
combined company following the closing of the Merger;
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the progress, scope or duration of the development of product candidates or programs;
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the benefits that may be derived from, or the commercial or market opportunity of, the product candidates of Angion, Elicio
and the combined company;
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the ability of Angion and Elicio to protect their intellectual property rights;
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the ability of Angion and the combined company to maintain compliance with Nasdaq listing standards;
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the level of net cash held by Angion at the closing of the Merger;
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the anticipated operations, financial position, losses, costs or expenses of Angion, Elicio or the combined company following
the closing of the Merger;
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statements regarding future economic conditions or performance;
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statements concerning proposed products or product candidates;
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the approval and closing of the Merger, including the timing of the Merger, the ability of Angion to obtain a sufficient
number of proxies to approve the Merger, other conditions to the completion of the Merger, the Exchange Ratio, and relative ownership levels as of the closing of the Merger;
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the expected benefits of and potential value created by the Merger for the stockholders of Angion; and
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statements of belief and any statement of assumptions underlying any of the foregoing.
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For a discussion of the factors that may cause Angion, Elicio or
the combined company’s actual results, performance or achievements following closing of the proposed Merger to differ materially from any future results, performance or achievements expressed or implied in such forward-looking statements, and
for a discussion of risk associated with the ability of Angion and Elicio to complete the Merger and the effect of the Merger on the business of Angion, Elicio and the combined company following the completion of the Merger, see “Risk Factors” beginning on page 20 of this proxy statement/prospectus/information statement. Additional factors that could cause actual results to differ materially from those expressed
in the forward-looking statements are discussed in reports filed with the SEC by Angion. See “Where You Can Find More Information” beginning on page 307 of this proxy
statement/prospectus/information statement. There can be no assurance that the Merger will be completed, or if it is completed, that it will close within the anticipated time period or that the expected benefits of the Merger will be realized.
If any of these risks or uncertainties materializes or any of
these assumptions proves incorrect, the results of Angion, Elicio or the combined company following completion of the Merger could differ materially from the forward-looking statements. All forward-looking statements in this proxy
statement/prospectus/information statement are current only as of the date on which the statements were made. Angion and Elicio do not undertake any obligation (and expressly disclaim any such obligation) to publicly update any forward-looking
statement to reflect events or circumstances after the date on which any statement is made or to reflect the occurrence of unanticipated events, except as required by applicable law.
In addition, statements that “Angion believes” or “Elicio
believes” and similar statements reflect Angion’s or Elicio’s beliefs and opinions on the relevant subject. These statements are based upon information available to Angion or Elicio, as the case may be, as of the date of this prospectus/proxy
statement, and while Angion or Elicio, as the
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case may be, believes such information forms a reasonable basis for such
statements, such information may be limited or incomplete, and such statements should not be read to indicate that such party has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These
statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
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The Angion special meeting (which will also serve as Angion’s
2023 annual meeting of stockholders) will be held exclusively online via live audio-only webcast on May 31, 2023 at 9:00 a.m. Pacific Time. The Angion special meeting can be accessed by visiting www.virtualshareholdermeeting.com/ANGN2023SM,
where you will be able to vote your shares and submit questions during the Angion special meeting webcast by logging in to the website listed above using the 16-digit control number included in your proxy card. Online check-in will begin at
8:45 a.m. Pacific Time, and Angion encourages you to allow ample time for the online check-in procedures. Angion intends to mail this proxy statement/prospectus/information statement and the enclosed form of proxy to its stockholders entitled
to vote at the Angion special meeting on or about April 28, 2023. This proxy statement/prospectus/information statement provides Angion stockholders with information they need to know to be able to vote or instruct their vote to be cast at
the Angion special meeting.
The purpose of the Angion special meeting is:
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Proposal 1 (Stock Issuance
Proposal) – To consider and vote upon a proposal to approve the issuance of shares of Angion capital stock pursuant to the Merger, which will represent more than 20% of the shares of Angion common stock outstanding immediately
prior to the Merger and result in a change of control of Angion, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b);
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Proposal 2 (Reverse Stock Split
Proposal) – To consider and vote upon the proposed amendment to the amended and restated certificate of incorporation of Angion to effect a reverse stock split of Angion common stock at a ratio within the range between 5-for-1
to 30-for-1 (with such ratio to be mutually agreed upon by Angion and Elicio prior to the effectiveness of the Merger or, if the Stock Issuance Proposal is not approved by Angion stockholders, determined solely by the Angion Board);
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Proposal 3 (Exculpation
Proposal) – To consider and vote upon the proposed amendment to the amended and restated certificate of incorporation of Angion to provide for the exculpation of officers.
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Proposal 4 (Director Election
Proposal) – To consider and vote upon the election of the Angion Board’s nominees, Itzhak Goldberg, M.D., F.A.C.R. and Allen R. Nissenson, M.D., to the Angion Board in the class of directors to hold office until the 2026 Annual
Meeting of Stockholders;
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Proposal 5 (Accounting Firm
Proposal) – To consider and vote upon the ratification of the selection of Moss Adams LLP as Angion’s independent registered public accounting firm for the fiscal year ending December 31, 2023; and
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Proposal 6 (Adjournment
Proposal) – To consider and vote upon the postponement or adjournment of the Angion special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal and/or
the Reverse Stock Split Proposal.
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Angion expects to transact no business other than the Angion
Proposals at the Angion special meeting except such business as may properly be brought before the Angion special meeting or any adjournment or postponement thereof.
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The Angion Board has determined and believes that the issuance of shares of Angion common stock pursuant to the Merger
Agreement is in the best interests of Angion and its stockholders and has approved such proposal. The Angion Board unanimously recommends that Angion stockholders vote “FOR” the Stock Issuance
Proposal as described in this proxy statement/prospectus/information statement.
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The Angion Board has determined and believes that it is advisable to, and in the best interests of, Angion and its
stockholders to approve the amendment to the certificate of incorporation of Angion effecting a reverse stock split at a ratio in the range from 5-for-1 to 30-for-1, with such specific ratio to be mutually agreed upon by Angion and
Elicio or, if the Stock Issuance Proposal is not approved by Angion
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stockholders, determined solely by the Angion Board following the Angion special
meeting as described in this proxy statement/prospectus/information statement. The Angion Board unanimously recommends that Angion stockholders vote “FOR” the Reverse Stock Split Proposal as described in
this proxy statement/prospectus/information statement.
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The Angion Board has determined and believes that it is advisable to, and in the best interests of, Angion and its
stockholders to approve the amendment to the amended and restated certificate of incorporation of Angion to provide for the exculpation of officers. The Angion Board unanimously recommends that Angion stockholders vote “FOR” the Exculpation Proposal as described in this proxy statement/prospectus/information statement.
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The Angion Board has determined and believes that it is advisable to, and in the best interests of, Angion and its
stockholders to elect each of Itzhak Goldberg, M.D., F.A.C.R. and Allen R. Nissenson, M.D., to serve on the Angion Board in the class of directors with terms expiring at the 2026 Angion Annual Meeting of Stockholders. The Angion Board
unanimously recommends that Angion stockholders vote “FOR” each of the director nominees named in the Director Election Proposal as described in this proxy statement/prospectus/information
statement.
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The Angion Board has determined and believes that it is advisable to, and in the best interests of, Angion and its
stockholders to ratify the appointment of Moss Adams LLP as Angion’s independent registered public accounting firm for the fiscal year ending December 31, 2023. The Angion Board unanimously recommends that Angion stockholders vote “FOR” the Accounting Firm Proposal as described in this proxy statement/prospectus/information statement.
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The Angion Board has determined and believes that adjourning the Angion special meeting, if necessary, to solicit additional
proxies if there are not sufficient votes in favor of the Stock Issuance Proposal and/or the Reverse Stock Split Proposal is advisable to, and in the best interests of, Angion and its stockholders and has approved and adopted the
proposal. The Angion Board unanimously recommends that Angion stockholders vote “FOR” the Adjournment Proposal to adjourn the Angion special meeting, if necessary, to solicit additional proxies if
there are not sufficient votes in favor of the Stock Issuance Proposal and/or the Reverse Stock Split Proposal.
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Only holders of record of Angion common stock at the close of
business on the record date, April 17, 2023, are entitled to notice of, and to vote at, the Angion special meeting. There were approximately 120 holders of record of Angion common stock at the close of business on the record date. At the close
of business on the record date, 30,114,190 shares of Angion common stock were issued and outstanding. Each share of Angion common stock entitles the holder thereof to one vote on each matter submitted for stockholder approval. See the section
titled “Principal Stockholders of Angion” beginning on page 301 of this proxy statement/prospectus/information statement for information regarding persons known to Angion’s
management to be the beneficial owners of more than 5% of the outstanding shares of Angion common stock.
The proxy accompanying this proxy statement/prospectus/information
statement is solicited on behalf of the Angion Board for use at the Angion special meeting.
If you are a stockholder of record of Angion as of the record date
referred to above, you may vote in person at the Angion special meeting or vote by proxy on the Internet, by telephone, or using the enclosed proxy card. Whether or not you plan to attend the Angion special meeting, Angion urges you to vote by
proxy to ensure your vote is counted. You may still attend the Angion special meeting and vote in person if you have already voted by proxy. As a stockholder of record, you are entitled:
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to vote in person, come to the Angion special meeting and Angion will give you a ballot when you arrive;
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to vote using the proxy card, simply mark, sign and date your proxy card and return it promptly in the postage-paid envelope
provided. If you return your signed proxy card to Angion before the Angion special meeting, Angion will vote your shares as you direct;
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to vote on the Internet, go to the website on the proxy card or voting instruction form to complete an electronic proxy
card. You will be asked to provide the company number and control number from the enclosed proxy card. Your vote must be received by 11:59 p.m. Eastern Time on May 30, 2023 to be counted.
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to vote by telephone, go to the website on the proxy card or voting instruction form to complete an electronic proxy card,
or call the toll-free number on the proxy card or voting instruction form to vote. You will be asked to provide the company number and control number from the enclosed proxy card. Your vote must be received by 11:59 p.m. Eastern Time
on May 30, 2023 to be counted.
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If your Angion shares are held by your broker as your nominee,
that is, in “street name,” the enclosed voting instruction card is sent by the institution that holds your shares. Please follow the instructions included on that proxy card regarding how to instruct your broker to vote your Angion shares.
If you do not give instructions to your broker, the question of
whether your broker or nominee will still be able to vote your shares depends on whether the NYSE deems the particular proposal to be a “routine” matter and how your broker or nominee exercises any discretion they may have in the voting of the
shares that you beneficially own. Brokers and nominees can use their discretion to vote “uninstructed” shares with respect to matters that are considered to be “routine,” but not with respect to “non-routine” matters. Under the rules and
interpretations of the NYSE, “non-routine” matters are matters that may substantially affect the rights or privileges of stockholder, such as mergers, stockholder proposals, elections of directors (even if not contested), executive compensation
(including any advisory stockholder votes on executive compensation and on the frequency of stockholder votes on executive compensation), and certain corporate governance proposals, even if management-supported.
For any Angion Proposal that is considered a “routine” matter,
your broker or nominee may vote your shares in its discretion either for or against the proposal even in the absence of your instruction. For any Angion Proposal that is considered a “non-routine” matter for which you do not give your broker
instructions, the Angion shares will be treated as broker non-votes. Broker non-votes occur when a beneficial owner of shares held in street name does not give instructions to the broker or nominee holding the shares as to how to vote on
matters deemed “non-routine.”
Angion believes that only the Reverse Stock Split Proposal and the
Accounting Firm Proposal will be considered “routine” matters by the NYSE and all of the other Angion Proposals will be considered “non-routine” matters. Therefore, if you are a beneficial owner and want to ensure that shares you beneficially
own are voted in favor or against any or all of the Angion Proposals, the only way you can do so is to give your broker or nominee specific instructions as to how the shares are to be voted.
All properly executed proxies that are not revoked will be voted
at the Angion special meeting and at any adjournments or postponements of the Angion special meeting in accordance with the instructions contained in the proxy. If a holder of Angion common stock executes and returns a proxy and does not
specify otherwise, the shares represented by that proxy will be voted:
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“FOR” the Stock Issuance Proposal to approve the issuance of shares of Angion common
stock pursuant to the Merger Agreement;
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“FOR” the Reverse Stock Split Proposal to approve the amendment to the certificate of
incorporation of Angion effecting a reverse stock split at a ratio in the range from 5-for-1 to 30-for-1 with such specific ratio to be mutually agreed upon by Angion and Elicio or, if the Stock Issuance Proposal is not approved by
Angion stockholders, determined solely by the Angion Board following the Angion special meeting;
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FOR” the Exculpation Proposal to approve the amendment to the amended and restated
certificate of incorporation of Angion to provide for the exculpation of officers;
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“FOR” the election of each of the two director nominees named in the Director
Election Proposal in this proxy statement/prospectus/information statement to serve on the Angion Board as directors for a three-year term expiring at the 2026 Angion Annual Meeting of Stockholders;
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“FOR” the Accounting Firm Proposal to ratify the appointment of Moss Adams LLP as
Angion’s independent registered public accounting firm for the fiscal year ending December 31, 2023; and
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“FOR” the Adjournment Proposal to adjourn the Angion special meeting, if necessary,
to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal and/or the Reverse Stock Split Proposal in accordance with the recommendation of the Angion Board.
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Angion stockholders of record, other than those Angion
stockholders who have executed the Support Agreements, may change their vote at any time before their proxy is voted at the Angion special meeting in one of three ways. You can revoke your proxy at any time before it is exercised by delivering
a properly executed, later-dated proxy (including a proxy submitted by Internet or telephone), by delivering a written revocation before the Angion special meeting or by voting at the Angion special meeting. Executing your proxy in advance will
not limit your right to vote at the Angion special meeting if you decide to attend the Angion special meeting. However, if your shares are held in the name of a broker, bank or other holder of record, you cannot vote at the Angion special
meeting unless you have a legal proxy, executed in your favor, from the holder of record. If a Angion stockholder of record or a stockholder who owns Angion shares in “street name” has instructed a broker to vote its shares of Angion common
stock, the stockholder must follow directions received from its broker to change those instructions.
A complete list of Angion stockholders entitled to vote at the
Angion special meeting will be available for examination by any Angion stockholder in the Corporate Secretary’s Office at Angion Biomedica Corp., 7-57 Wells Avenue, Newton, Massachusetts 02459, for purposes pertaining to the Angion special
meeting, during ordinary business hours for a period of 10 days before the Angion special meeting, and at the Angion special meeting. A complete list of Angion stockholders entitled to vote at the Angion special meeting will also be available
for inspection during the Angion special meeting at www.virtualshareholdermeeting.com/ANGN2023SM by logging in with your 16-digit control number(s).
The presence, in person or represented by proxy, at the Angion
special meeting of the holders of a majority of the shares of Angion common stock outstanding and entitled to vote at the Angion special meeting is necessary to constitute a quorum at the meeting. Abstentions and broker non-votes will be
counted towards a quorum. Assuming a quorum is present, the required vote for each of the Angion Proposals is as follows:
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Proposal Number
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Proposal Description
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Vote Required for Approval
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Effect of
Abstentions
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Effect of
Broker
Non-Votes
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1
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Stock Issuance Proposal
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FOR votes from the
holders of a majority of shares voting affirmatively or negatively (excluding abstentions and broker non-votes) on the matter
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None
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None
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2
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Reverse Stock Split Proposal
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FOR votes from the
holders of a majority of outstanding shares
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Against
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Against
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3
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Exculpation Proposal
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FOR votes from the
holders of a majority of outstanding shares
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Against
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Against
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4
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Director Election Proposal
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Two nominees receiving the most FOR
votes from the holders of shares present and entitled to vote
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Withheld votes will have no effect
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None
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5
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Accounting Firm Proposal
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FOR votes from the
holders of a majority of shares voting affirmatively or negatively (excluding abstentions and broker non-votes) on the matter
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None
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None
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Proposal Number
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Proposal Description
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Vote Required for Approval
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Effect of
Abstentions
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Effect of
Broker
Non-Votes
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6
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Adjournment Proposal
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FOR votes from the
holders of a majority of shares voting affirmatively or negatively (excluding abstentions and broker non-votes) on the matter
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None
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None
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The information in the preceding table with respect to the effect
of broker non-votes may be incorrect or change before the special meeting. Therefore, if you are a beneficial owner and want to ensure that shares you beneficially own are voted in favor or against any or all of the Angion Proposals, the only
way you can do so is to give your broker or nominee specific instructions as to how the shares are to be voted.
If on the date of the Angion special meeting, or a date preceding
the date on which the Angion special meeting is scheduled, Angion reasonably believes that (i) it will not receive proxies sufficient to obtain the required vote to approve the Angion Proposals, whether or not a quorum would be present or
(ii) it will not have sufficient shares of Angion common stock represented (whether in person or by proxy) to constitute a quorum necessary to conduct the business of the Angion special meeting, Angion may postpone or adjourn, or make one or
more successive postponements or adjournments of, the Angion special meeting as long as the date of the Angion special meeting is not postponed or adjourned more than an aggregate of 30 calendar days in connection with any postponements or
adjournments.
No Angion Proposal is contingent upon any other Angion Proposal.
However, each of the Stock Issuance Proposal and the Reverse Stock Split Proposal is a condition to the consummation of the Merger. Therefore, the Merger cannot be consummated without the approval of the Stock Issuance Proposal and the Reverse
Stock Split Proposal.
As of April 1, 2023, the directors and executive officers of
Angion owned approximately 19.6% of the outstanding shares of Angion common stock entitled to vote at the Angion special meeting. The directors and executive officers of Angion owning these shares are subject to support agreement to vote all
shares of Angion common stock owned by them as of the record date in favor of the issuance of shares of Angion common stock in the merger pursuant to the Merger Agreement and the reverse stock split. As of April 1, 2023, Angion is not aware of
any affiliate of Elicio owning any shares of Angion common stock entitled to vote at the Angion special meeting.
You or your authorized proxy may attend the Angion special meeting
virtually if you were a registered or beneficial stockholder of Angion common stock as of the Angion record date.
To participate in the Angion special meeting, visit
www.virtualshareholdermeeting.com/ANGN2023SM and enter the 16-digit control number included on your proxy card or on the instructions that accompanied your proxy materials. If you wish to submit a question during the Angion special meeting, log
into the virtual meeting platform at www.virtualshareholdermeeting.com/ANGN2023SM, type your question into the “Ask a Question” field, and click “Submit.” Angion will respond to as many properly submitted questions during the relevant portion
of the Angion special meeting agenda as time allows.
If Angion experiences technical difficulties during the Angion
special meeting (e.g., a temporary or prolonged power outage), it will determine whether the Angion special meeting can be promptly reconvened (if the technical difficulty is temporary) or whether the Angion special meeting will need to be
reconvened on a later day (if the technical difficulty is more prolonged). In any situation, Angion will promptly notify stockholders of the decision via www.virtualshareholdermeeting.com/ANGN2023SM. Angion will have technicians ready to assist
you with any technical difficulties you may have accessing the virtual meeting website. If you encounter any difficulties accessing the virtual meeting website during the check-in or meeting time, please call the technical support number that
will be posted on the virtual meeting website log-in page at www.virtualshareholdermeeting.com/ANGN2023SM.
Please note that you will not be able to attend the Angion special
meeting in person.
The Angion special meeting will be held virtually conducted via
live audio webcast. You will be able to attend the Angion special meeting by visiting www.virtualshareholdermeeting.com/ANGN2023SM and entering your
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control number as further explained in the accompanying proxy
statement/prospectus/information statement. Angion recommends that you log in at least 15 minutes before the Angion special meeting to ensure you are logged in when the meeting starts.
If you own shares in street name through an account with a bank,
broker or other nominee, please send proof of your Angion share ownership as of the Angion record date (for example, a brokerage firm account statement or a “legal proxy” from your intermediary) along with your registration request. If you are
not sure what proof to send, check with your intermediary.
If your shares are registered in your name with Angion’s stock
registrar and transfer agent, Continental Stock Transfer & Trust Company, no proof of ownership is necessary because Angion can verify your ownership.
The Angion Board is soliciting proxies for the Angion special
meeting from its stockholders. Angion will bear a portion of the cost of the solicitation of proxies, including preparation, assembly and delivery, as applicable, of this joint proxy statement/prospectus/information statement, the Angion proxy
card and any additional materials furnished to Angion stockholders. Proxies may be solicited by directors, officers and a small number of Angion’s regular employees by mail, email, in person and by telephone, but such persons will not receive
any additional compensation for these activities. Angion has retained Mackenzie Partners, Inc., a proxy solicitation firm, to assist in the solicitation of proxies for a fee of approximately $9,500 plus reasonable out-of-pocket costs and
expenses.
Angion will appoint Broadridge Investor Communication Solutions,
Inc. (Broadridge) to serve as the Inspector of Election for the Angion special meeting. Broadridge will independently tabulate affirmative and negative votes and abstentions.
Subject to certain restrictions contained in the Merger Agreement,
the Angion special meeting may be adjourned to allow additional time for obtaining additional proxies. No notice of an adjourned meeting need be given if the time and place thereof are announced at the Angion special meeting at which the
adjournment was taken unless: the adjournment is for more than 30 days, in which case a notice of the adjourned meeting will be given to each Angion stockholder of record entitled to vote at the Angion special meeting; or if, after the
adjournment, a new record date for determination of Angion stockholders entitled to vote is fixed for the adjourned meeting, in which case the Angion Board will fix as the record date for determining Angion stockholders entitled to notice of
such adjourned meeting the same or an earlier date as that fixed for determination of Angion stockholders entitled to vote at the adjourned meeting, and will give notice of the adjourned meeting to each Angion stockholder of record as of such
record date.
At any adjourned meeting, all proxies will be voted in the same
manner as they would have been voted at the original convening of the Angion special meeting, except for any proxies that have been effectively revoked or withdrawn prior to the adjourned meeting.
As of the date of this proxy statement/prospectus/information
statement, the Angion Board does not know of any business to be presented at the Angion special meeting other than as set forth in the notice accompanying this proxy statement/prospectus/information statement. If any other matters should
properly come before the Angion special meeting, it is intended that the shares represented by proxies will be voted with respect to such matters in accordance with the judgment of the persons voting the proxies.
If you need assistance with submitting a proxy to vote your shares
via the Internet, by telephone or by completing your Angion proxy card, or have questions regarding the Angion special meeting, please contact MacKenzie Partners, Inc, the proxy solicitor for Angion, at 1-800-322-2885 (toll-free), 212-929-5500
(call collect) or by email at Angion@mackenziepartners.com.
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Your vote is very important regardless of
the number of shares of Angion common stock that you own, and the matters to be considered at the Angion special meeting are of great importance to the stockholders of Angion. Accordingly, you are urged to read and carefully consider the
information contained in this proxy statement/prospectus/information statement and promptly submit your proxy via the Internet or by telephone or complete, date, sign and promptly return the enclosed Angion proxy card or voting instruction form
in the enclosed postage-paid envelope. If you submit your proxy via the Internet or by telephone, you do not need to return the enclosed Angion proxy card.
Please vote your shares via the Internet or by
telephone, or sign, date and return a Angion proxy card or voting instruction form promptly to ensure that your shares can be represented, even if you otherwise plan to attend the Angion special meeting.
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Prior to Angion’s July 25, 2022 announcement of its intention to
explore strategic options for enhancing and preserving stockholder value, Angion was a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address chronic
and progressive fibrotic diseases. Since 2014, Angion has been focused on the clinical development of its ANG-3070 and ANG-3777 programs and translational work necessary to bring Angion’s pipeline programs to the clinic.
As part of the ongoing consideration and evaluation of its
long-term prospects and strategies, the Angion Board frequently reviews, with Angion’s management and outside advisors, strategic and financial alternatives, considering developments in Angion’s business, the sectors in which it competes, the
economy generally and financial markets, all with the goal of enhancing value for its stockholders. As part of this process, from time to time, members of Angion’s management and/or its advisors have engaged in business development and/or
strategic discussions with industry participants, including strategic out-licensing and collaboration arrangements.
Until December 2021, ANG-3777, a hepatocyte growth factor mimetic,
was Angion’s lead product candidate. In December 2021, Angion discontinued its clinical development plan for ANG-3777 because Angion did not believe the earlier Phase 2 and Phase 3 clinical trial results in the respective indications provided
sufficiently strong support for regulatory approval.
After discontinuing the clinical development plan for ANG-3777,
Angion continued developing its subsequent lead product candidate, ANG-3070, a highly selective oral tyrosine kinase receptor inhibitor in development as a treatment for fibrotic diseases, particularly in the kidney and lung.
On June 27, 2022, the Angion Board held a videoconference meeting,
with representatives of management and representatives of Cooley LLP (“Cooley”), outside legal counsel to Angion, also attending. At this meeting, the Angion Board discussed information regarding the ongoing ANG-3070 Phase 2 dose-finding trial
and determined that the risk versus benefit profile of ANG-3070 in patients with established serious kidney diseases did not support continuation of the Phase 2 dose-finding trial.
On June 29, 2022, Angion issued a press release announcing the
decision to discontinue the Phase 2 dose-finding trial of ANG-3070. Angion announced plans to evaluate the best path forward for ANG-3070, as well as plans to evaluate strategic and operational options for Angion. Angion also announced that it
expected to report cash and cash equivalents of greater than $60 million at the end of the second quarter of 2022.
On July 18, 2022, the Angion Board held a videoconference meeting,
with representatives of Angion’s management and representatives of Cooley attending, to conduct a review of the value creation timelines for Angion’s current assets and to discuss strategic options for Angion, as well as its likely cash runway
under such scenarios. The strategic options the Angion Board considered were remaining as a standalone company, dissolving Angion and distributing remaining cash to stockholders, and sale of the company, including through a reverse merger, sale
to another company and sale to a private investor. The Angion Board discussed its fiduciary duties in connection with the evaluation of the strategic options available to Angion. The Angion Board considered the benefits and risks of the various
strategic alternatives, including the likelihood of finding a counterparty for a transaction, and the timeline and costs associated with such strategic options. The Angion Board also discussed steps to preserve and extend its cash runway.
At this same meeting, the Angion Board discussed whether to engage
a financial advisor to assist the Angion Board in evaluating such potential transactions. The Angion Board considered proposals received from two potential financial advisors with expertise in mergers and acquisitions in the biotechnology
industry, including Oppenheimer. The Angion Board discussed with representatives of Oppenheimer its existing relationships with potential counterparties to a strategic transaction, and any potential conflicts of interest as a result thereof.
The Angion Board also considered that Oppenheimer is an internationally recognized investment banking, financial advisory and securities firm with expertise in the biopharmaceutical sector that is regularly engaged in the valuation and
financial assessment of businesses and securities in connection with mergers and acquisitions, including reverse merger transactions. The Angion Board then authorized Angion management to negotiate the terms of engagement of, and subsequently
on July 24, 2022 authorized Angion management to engage, Oppenheimer as Angion’s exclusive financial advisor.
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On July 25, 2022, Angion issued a press release announcing the
decision to commence a process to explore and evaluate strategic options to enhance and preserve stockholder value, including through a potential reverse merger or other business combinations, and the engagement of Oppenheimer as Angion’s
exclusive financial advisor to assist in this process.
On August 8, 2022, at the direction of the Angion Board,
representatives of Oppenheimer began contacting a total of 234 parties to solicit interest in a potential transaction with Angion.
On August 15, 2022, Angion reported cash and cash equivalents
totaling $63.4 million as of June 30, 2022, which was estimated to be sufficient to fund projected operating requirements for at least 12 months.
From August 22, 2022 through October 27, 2022, Angion received 44
written indications of interest, including from Company A, Company B, Company C, Company D, Company E, Company F and Company G.
On August 22, 2022, Angion received a non-binding indication of
interest from Company A. Company A proposed a reverse merger, with a post-closing ownership split of 75.8% for Company A and 24.2% for Angion based on respective valuations of $125 million and $40 million and assuming Angion’s cash balance at
closing is $35 million, which would be adjusted for Angion’s actual net cash at closing.
On August 23, 2022, Angion received a non-binding indication of
interest from Company B. Company B proposed a reverse merger with a post-closing ownership split of 83% for Company B and 17% for Angion based on respective valuations of $241 million and $50 million and assuming Angion’s cash balance at
closing is $35 million, which would be adjusted for Angion’s actual net cash at closing. Company B also proposed a concurrent financing of $40-50 million in the combined entity which would be consummated at the closing of the transaction.
On August 24, 2022, Angion received a non-binding indication of
interest from Company C. Company C proposed a reverse merger with a post-closing ownership split of 30% for Company C and 70% for Angion based on respective valuations of $20 million and $46.7 million and assuming Angion’s cash balance at
closing is $35 million, which would be adjusted for Angion’s actual net cash at closing. Company C also proposed that Angion’s management would remain in place at the post-closing entity to manage the company.
That same day, Angion received a non-binding indication of
interest from Company D. Company D proposed a reverse merger with a post-closing ownership split of 78.4% for Company D and 21.6% for Angion based on respective valuations of $199.6 million and $55.0 million and assuming Angion’s cash balance
at closing is $35 million, which would be adjusted for Angion’s actual net cash at closing. Company D also proposed a concurrent financing of $15 million in the combined entity which would be consummated at the closing of the transaction.
On August 29, 2022, Angion received a non-binding indication of
interest from Company E. Company E proposed a reverse merger with a post-closing ownership split of 70.0% for Company E and 30.0% for Angion based on respective valuations of $125.0 million and $42.0 million and assuming Angion’s cash balance
at closing is $35 million, which would be adjusted for Angion’s actual net cash at closing. Company E also proposed a concurrent financing of up to $45 million in the combined entity which would be consummated at the closing of the transaction.
From August 31, 2022 through December 6, 2022, over the course of
the strategic review activities, Angion executed mutual confidential non-disclosure agreement with 30 companies, none of which contained a standstill provision. Representatives of Angion management, with the assistance of representatives of
Oppenheimer, also held management presentations with various potential counterparties, including each of Elicio, Company A, Company B, Company C, Company D, Company E, Company F and Company G.
On September 9, 2022, the Angion Board held a videoconference
meeting, with representatives of management, representatives of Oppenheimer and representatives of Cooley also attending. At this board meeting, the Angion Board approved the recommendation of Angion management to invite Company A, Company B,
Company C, Company D and Company E to the next round of the process, during which the parties would conduct mutual due diligence.
The candidates were selected based on Angion management’s
evaluation of certain characteristics, including the strength of the candidate’s programs and intellectual property from clinical, regulatory and commercial perspectives as well as financial terms of the counterparty’s proposal relative to the
risks and potential benefits of such counterparty. In evaluating the strength of the candidate’s programs and intellectual property, the Angion Board considered factors such as the stage of the candidate’s development programs, the strength of
the pre-clinical and clinical data, the number of programs as well as the potential for success and level of program risk. In evaluating the
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financial terms of the counterparty’s proposal, the Angion Board considered
factors such as the rationale for the counterparty valuation, the need for additional financing to achieve clinical milestones, the ability of the counterparty to meet the reporting requirements of a public company, the timeline for value
creation for Angion stockholders as well as the experience of the counterparty’s management.
On September 12, 2022, Angion, with representatives of Oppenheimer
in attendance, held a telephonic meeting with representatives of each of Company A, Company B, Company C, Company D and Company E to invite them to the second-round of the process. An auction draft merger agreement was subsequently uploaded to
Angion’s data room, as well as drafts of the related forms of lock-up agreement, Angion support agreement and counterparty support agreement.
On September 13, 2022, Company A, Company C and Company D were
granted access to Angion’s virtual data room.
That same day, Company A granted Angion access to its virtual data
room.
From September 13, 2022 through October 18, 2022, Angion and
Company A conducted diligence on each other, including holding various financial and science due diligence calls with the respective management of the parties as well as with consultants of Angion and Company A present.
On September 14, 2022, Company B granted Angion access to its
virtual data room, and on October 1, 2022, Company B was granted access to Angion’s virtual data room.
From September 14, 2022 through October 20, 2022, and in the case
of Company B, from October 1, 2022 through October 20, 2022, each of Angion and Company B conducted diligence on the other party, including holding various financial, intellectual property, scientific and clinical diligence calls with the
respective management of the parties with the consultants, and representatives of the financial and legal advisors of each of Angion and Company B present.
On September 20, 2022, Angion withdrew from its consideration
Company E after Company E communicated a proposed increase in its valuation and a corresponding reduction in the post-closing ownership split for Angion from 30% to 17%.
That same day, Company C granted Angion access to its virtual data
room. From September 20, 2022 through September 30, 2022, Angion and Company C conducted diligence on each other, including holding various financial, scientific and clinical diligence calls with the respective management of the parties with
representatives of the financial advisors of each of Angion and Company C present.
Also that same day, Company D communicated its decision to
withdraw from the process, after which Angion, with the assistance of representatives of Oppenheimer, discussed considering alternative candidates for a strategic transaction, in addition to continuing its diligence with respect to Company A,
Company B and Company C.
On September 30, 2022, representatives of Oppenheimer, Company C
and Company C’s financial advisor had a telephonic meeting, during which Company C communicated it would not proceed further in the process after Company C communicated that potential investors indicated a lack of support for a concurrent
private investment in the combined company and therefore it would not be able to consummate a transaction.
On October 3, 2022, counsel to Company A sent a revised draft of
the merger agreement to Cooley.
That same day, counsel to Company B sent a revised draft of the
merger agreement to Cooley.
On October 4, 2022, Angion and representatives of Oppenheimer
contacted Company G regarding pursuing a potential transaction with Angion.
On October 7, 2022, although up to this point Elicio had not yet
submitted an indication of interest to Angion, due to Angion's interest in Elicio's pre-clinical and clinical programs, representatives of Oppenheimer, at the direction of Angion management, contacted Elicio regarding participating in the
second-round of the process, during which the parties would conduct mutual due diligence.
From October 7, 2022 through October 26, 2022, Angion’s management
team and Elicio’s management team continued to engage in discussions regarding a potential strategic transaction.
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On October 10, 2022, Angion and Elicio entered a Mutual
Non-Disclosure Agreement, which did not include a standstill.
On October 11, 2022, representatives of Oppenheimer, at the
direction of Angion management, contacted Company F regarding participating in the second-round of the process, during which the parties would conduct mutual due diligence.
On October 13, 2022, representatives of Cooley sent a revised draft
of the merger agreement to Company B.
Between October 13, 2022 and October 20, 2022, Angion management
continued to conduct scientific and legal due diligence on Company B’s intellectual property. After concluding its review, Angion management determined not to move forward with Company B due to risks surrounding its clinical development
programs.
On October 14, 2022, Angion received a non-binding indication of
interest from Company G. Company G proposed a reverse merger with a post-closing ownership split of 75% for Company G and 25% for Angion based on respective valuations of $112.5 million and $37.5 million and assuming Angion’s cash balance at
closing is $35 million, which would be adjusted for Angion’s actual net cash at closing. Company G also proposed that Angion make a $1 million non-refundable payment to Company G at the signing of non-binding letter of interest and an
additional $1 million non-refundable payment at signing of the merger agreement to cover initial transaction expenses, to be credited towards Angion net cash at the closing of the potential transaction.
On October 19, 2022, Company F was granted access to Angion’s
virtual data room, and on October 21, 2022, Company F granted Angion access to its virtual data room.
From October 19, 2022 through December 5, 2022, and in the case of
Angion, from October 21, 2022 through December 5, 2022, each of Angion and Company F conducted diligence on the other party, including holding various financial and intellectual property diligence calls with the respective management of the
parties with representatives of the financial and legal advisors of each of Angion and Company F present.
On October 21, 2022, representatives of Oppenheimer had a
telephonic meeting with Company B, during which, at the direction of the Angion Board, the representatives of Oppenheimer communicated that Angion determined not to move forward with Company B.
On October 28, 2022, Angion received a non-binding indication of
interest from Elicio (the “Elicio Initial Proposal”). Elicio proposed a reverse merger with a post-closing ownership split of 67.74% for Elicio and 32.23% for Angion based on respective valuations of $105 million and $50 million and assuming
Angion’s cash balance at closing is $35 million, which would be adjusted for Angion’s actual net cash at closing. Elicio’s non-binding indication of interest also indicated its intention to proceed with a capital raise in the near-term to fund
its operations.
On October 29, 2022, Angion received a second non-binding
indication of interest from Company G. Company G proposed a reverse merger with a post-closing ownership split of 68% for Company G and 32% for Angion based on respective valuations of $79.7 million and $37.5 million and assuming Angion’s cash
balance at closing is $35 million, which would be adjusted for Angion’s actual net cash at closing. Company G also removed the proposal that Angion make a $1 million non-refundable payment to Company G at the signing of non-binding letter of
interest and an additional $1 million non-refundable payment at signing of the merger agreement.
On November 3, 2022, Elicio granted Angion access to its virtual
data room, and Elicio was granted access to Angion’s virtual data room.
On November 7, 2022, Company G granted Angion access to its
virtual data room and Angion granted Company G access to its virtual data room.
From November 7, 2022 through November 10, 2022, Angion and
Company G conducted diligence on each other, including holding a financial diligence call with the respective management of the parties with representatives of Oppenheimer also present.
On November 10, 2022, representatives of Oppenheimer and Company G
held a videoconference meeting, during which Company G communicated it would not proceed further in the process due to the expected timeline and costs associated with consummating a transaction.
On November 11, 2022, representatives of Oppenheimer, Angion’s
management and consultants to Angion held a teleconference with representatives of Elicio’s management to discuss the indications being pursued by Elicio.
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On November 15, 2022, representatives of Oppenheimer, Angion’s
management and consultants to Angion held a diligence call with Elicio’s management.
On November 17, 2022, the Angion Board held a videoconference
meeting, with representatives of management, representatives of Oppenheimer and representatives of Cooley also attending. At this board meeting, Angion management provided the Angion Board with an update with respect to the strategic
transaction process, including the counterparties under consideration as well as the expected timeline of the process. The Angion Board considered the Elicio Initial Proposal and discussed Elicio’s pre-clinical and clinical programs and its
current financial position. Angion management updated the Board with respect to the scientific diligence efforts conducted to date on Elicio, as well as the positive feedback received with respect to Elicio’s programs from consultants as well
as independent key opinion leaders. During this meeting, after considering Elicio’s request to enter into exclusivity to advance discussions regarding a potential strategic transaction, the Angion Board also delegated to Dr. Venkatesan the
authority to enter negotiations regarding exclusivity with Elicio, subject to alignment on certain deal terms. Angion management also proposed scheduling a presentation by Elicio to the Angion Board regarding Elicio’s pre-clinical and clinical
programs, which was subsequently scheduled for November 21, 2022.
On November 18, 2022, after discussions between Angion’s
management team and Elicio’s management team, Angion sent Elicio a form of non-binding term sheet and requested that Elicio populate key terms pursuant to which it would be willing to pursue a potential transaction.
That same day, representatives of Oppenheimer, Company A and
Company A’s financial advisor held a telephonic meeting, during which Company A communicated it would not proceed further in the process due to Company A’s lack of preparedness to become a public company and concerns surrounding its corporate
structure.
On November 21, 2022, the Angion Board held a videoconference
meeting, with representatives of management, representatives of Oppenheimer and representatives of Cooley also attending. Representatives of Elicio management also attended this meeting. During this meeting, representatives of Elicio management
discussed with the Angion Board Elicio’s amphiphile (AMP) technology and Elicio’s pre-clinical and clinical programs, including ELI-002, an AMP therapeutic vaccine targeting KRAS-driven cancers, as well as Elicio’s plan to advance and evolve
the programs toward regulatory approval. Representatives of Elicio management also discussed with the Angion Board Elicio’s current financial position.
On November 28, 2022, Elicio submitted a non-binding term sheet
(the November 28 Term Sheet) that reflected a post-closing ownership split of 69.5% for Elicio and 30.5% for Angion equity holders on a fully diluted basis for each of Elicio and Angion, and, for Angion, using the treasury stock method and
excluding out-of-the-money options and out-of-the money warrants of Angion. The post-closing ownership reflected relative valuations of $105 million and $46 million and assumed Angion’s net cash at closing was $31 million. The November 28 Term
Sheet included terms for Angion to provide a $10 million bridge loan to Elicio, bearing interest at 1.0% annually upon signing of the merger agreement, with the loan forgiven at closing and credited towards Angion’s net cash. Additionally, the
November 28 Term Sheet proposed a nine member board of directors with six designees from Elicio and three designees from Angion, that the continuing executive officers and directors of the combined company, as well as the existing major
investors of each of Angion and Elicio, enter into lock-up agreements for a period of 180 days following the closing of the proposed merger, that officers and directors of each of Angion and Elicio, together with any stockholders of Angion and
Elicio, respectively, affiliated with any such officer or director, enter into support agreements to vote in favor of the proposed merger, a binding 45-day exclusivity provision, a detailed definition of Angion net cash, that the definitive
agreement include customary deal protections such as no-shop provisions and fiduciary outs for both parties, and included a condition to Elicio’s obligation to consummate the proposed merger that Angion net cash at closing be at least $25
million.
On November 30, 2022, Dr. Venkatesan and Robert Connelly, the
Chief Executive Officer of Elicio, held a telephonic meeting to discuss the November 28 Term Sheet, including the post-closing ownership split, the terms of the bridge loan, including a collar on the calculation for Angion net cash and Angion’s
proposal to reduce the exclusivity period to 30 days.
Later that day, representatives of Oppenheimer, at the direction
of Angion management, delivered to Elicio a revised non-binding term sheet (the November 30 Term Sheet), proposing a post-closing ownership of 65.0% for Elicio and 35.0% for Angion equity holders, but accepting that post-closing ownership would
be calculated on a fully diluted basis for each of Elicio and Angion, and, for Angion, using the treasury stock method and excluding out-of-the-money options and out-of-the money warrants of Angion. The November 30 Term Sheet included a collar
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such that the post-closing ownership split would be subject to adjustment only to
the extent Angion’s actual net cash at closing is greater than $30 million or less than $25 million. The November 30 Term Sheet revised the terms of the proposed bridge loan to have an original issue discount of 20% based on a principal amount
of $12.5 million, and added a conversion right to convert the principal amount of the bridge loan into Elicio common stock under certain circumstances. The November 30 Term Sheet also reduced the exclusivity period to 30 days, included a more
detailed definition of Angion net cash, proposed that stockholders affiliated with Angion directors, instead of major investors of Angion, be required to enter into the lock-up agreements, added the requirement that major investors of Elicio
enter into support agreements and removed the minimum Angion net cash condition.
That same day, Angion received a non-binding indication of
interest from Company F. Company F proposed a reverse merger with a post-closing ownership split of 78% for Company F and 22% for Angion based on respective valuations of $195 million and $55 million and assuming Angion’s cash balance at
closing is $30 million, which would be adjusted for Angion’s actual net cash at closing.
On December 3, 2022, Mr. Connelly sent Dr. Venkatesan a revised
non-binding term sheet (the December 3 Term Sheet), including a post-closing ownership of 69.5% for Elicio and 30.5% for Angion equity holders. The December 3 Term Sheet revised the collar range such that the post-closing ownership split would
be subject to adjustment to the extent Angion’s actual net cash at closing is greater than $33 million or less than $29 million, and also added that Angion net cash would be adjusted dollar-for-dollar to the extent Angion has any outstanding
lease obligations after closing. The December 3 Term Sheet also revised the terms of the proposed bridge loan, including removing the conversion right to convert the principal amount of the bridge loan into Elicio common stock. The December 3
Term Sheet also included certain changes to the definition of Angion net cash, clarified that holders of 5% or more of the outstanding securities of Elicio on a fully diluted basis would be required to enter into support agreements and added
back the minimum Angion net cash condition.
From December 3, 2022 through December 6, 2022, Angion management,
with the assistance of representatives of Oppenheimer and Cooley, continued to negotiate with Elicio outstanding issues in the December 3 Term Sheet, including the post-closing ownership split, the collar range and the terms of the bridge loan.
On December 5, 2022, representatives of Oppenheimer and Company F
had a telephonic meeting, during which Company F communicated it would not proceed further in the process due to time and costs associated with regulatory approval with respect to Company F’s clinical development plans.
On December 6, 2022, Dr. Venkatesan and Mr. Connelly held a
telephonic meeting to discuss outstanding issues in the December 3 Term Sheet.
Later that same day, Dr. Venkatesan sent Mr. Connelly a revised
non-binding term sheet (the December 6 Term Sheet), including a post-closing ownership of 67.5% for Elicio and 32.5% for Angion equity holders. The December 6 Term Sheet revised the collar range such that the post-closing ownership split would
be subject to adjustment to the extent Angion’s actual net cash at closing is greater than $33 million or less than $28 million. The December 6 Term Sheet also removed the terms of the bridge loan based on discussions between Angion management
and Elicio management for Elicio to procure alternative sources of interim financing. The December 6 Term Sheet also proposed that exclusivity end on December 31, 2022, included certain changes to the definition of Angion net cash and included
certain changes regarding the potential sale of Angion’s assets.
On December 7, 2022, Mr. Connelly sent Dr. Venkatesan a revised
non-binding term sheet (the December 7 First Term Sheet), including a post-closing ownership of 69.5% for Elicio and 30.5% for Angion equity holders. The December 7 First Term Sheet revised the collar range such that the post-closing ownership
split would be subject to adjustment to the extent Angion’s actual net cash at closing is greater than $31 million or less than $28 million, and added that the post-closing equity split would be adjusted dollar-for-dollar to the extent Elicio
closes any equity investment prior to the closing. The December 7 First Term Sheet also proposed a nine member board of directors with seven designees from Elicio and two designees from Angion, proposed that exclusivity end 30 days after the
signing of the term sheet and included certain changes to the definition of Angion net cash. Additionally, the December 7 First Term Sheet also included the option for current investors of Elicio (or affiliates thereof) to invest up to $15
million in equity of Elicio prior to Closing without consent from Angion.
After receiving the December 7 First Term Sheet, later that day,
representatives of Oppenheimer, at the direction of Angion management, communicated to Elicio management that Elicio would need to improve the terms of its proposal in order for discussions to proceed further.
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Later that same day, Elicio sent Angion a revised non-binding
term sheet (the December 7 Second Sheet), including a post-closing ownership of 68.0% for Elicio and 32.0% for Angion equity holders. The December 7 Second Term Sheet revised the collar range such that the post-closing ownership split would be
subject to adjustment to the extent Angion’s actual net cash at closing is greater than $31 million or less than $27 million, and removed the term that the post-closing equity split would be adjusted dollar-for-dollar to the extent Elicio
closes any equity investment prior to the closing. The December 7 Second Term Sheet proposed that the $15 million investment contemplated in the December 7 First Term Sheet may be in the form of debt, equity, or convertible debt or equity of
Elicio.
On December 8, 2022, Dr. Venkatesan sent Mr. Connelly a revised
term sheet with a clarifying change but otherwise accepting the terms of the December 7 Second Term Sheet.
On December 13, 2022, Elicio management discussed with
representatives of Oppenheimer that the intended source of interim financing had notified Elicio that it no longer intended to proceed with providing Elicio with interim financing. Representatives of Oppenheimer and Elicio discussed the
proposal for Angion to provide a bridge loan to Elicio, as had been previously contemplated in the November 30 Term Sheet and the December 3 Term Sheet.
On December 14, 2022, Dr. Venkatesan sent Mr. Connelly a revised
term sheet, executed by Angion (the December 14 Term Sheet), adding back terms for Angion to provide a bridge loan. The December 14 Term Sheet proposed that the bridge loan would have an original issue discount of 20% based on a principal
amount of $12.5 million. The December 14 Term Sheet also provided that if the merger was consummated or Elicio terminated the merger agreement for Angion’s breach of the merger agreement under certain circumstances, the bridge loan would bear
simple interest at 1.0% annually from and after the date of the merger agreement based on a principal amount equal to the amount actually advanced by Angion. Pursuant to the December 14 Term Sheet, if Angion terminated the merger agreement for
Elicio’s breach of the merger agreement under circumstances, the outstanding principal balance of the bridge note would be paid back by Elicio within ten business days of such termination. The December 14 Term Sheet also included a post-closing
ownership of 65.5% for Elicio and 34.5% for Angion equity holders. The December 14 Term Sheet revised the collar range such that the post-closing ownership split would be subject to adjustment to the extent Angion’s actual net cash at closing
is greater than $31.5 million or less than $26.5 million. The December 14 Term Sheet also included that Elicio would not have the right to terminate the merger agreement for any fiduciary out, proposed a nine member board of directors with six
designees from Elicio and three designees from Angion, proposed that exclusivity end on January 6, 2023 and included certain clarifications to the definition of Angion net cash. Additionally, the December 14 Term Sheet clarified that the $15
million investment contemplated by the December 7 Second Term Sheet, which investment may be in debt, equity, or convertible debt or equity of Elicio, would all be converted into equity of Elicio at the Closing.
On December 15, 2022, Angion’s management, Elicio’s management and
representatives of Oppenheimer held a teleconference meeting to discuss financial due diligence matters.
Later that day, Elicio sent Angion a revised non-binding term
sheet (the December 15 Term Sheet), proposing certain changes to the terms of the bridge loan and deleting the provision that Elicio would not have the right to terminate the merger agreement for any fiduciary out.
After receiving the December 15 Term Sheet, later that same day,
representatives of Oppenheimer, at the direction of Angion management, communicated to Elicio management that the changes in the December 15 Term Sheet were not acceptable to Angion and that the December 14 Term Sheet was Angion’s final offer.
On December 17, 2022, Elicio accepted the terms of the December 14
Term Sheet and delivered a countersigned term sheet to Angion.
On December 20, 2022, Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C. (Mintz Levin), outside legal counsel to Elicio, sent a revised draft of the merger agreement to Angion and Cooley.
Later that same day, Mintz Levin sent revised drafts of the forms
of lock-up agreement, Angion support agreement and Elicio support agreement, and the agreements were subsequently negotiated and finalized.
On December 22, 2022, the Angion Board held a videoconference
meeting, with representatives of management and representatives of Cooley also attending. At this board meeting, Angion management provided the Angion Board with an update with respect to the potential strategic transaction with Elicio,
including the key terms of the December 14 Term Sheet.
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On December 23, 2022, Cooley sent Mintz Levin a revised draft
of the merger agreement, which, among other things, limited the circumstances under which Elicio can terminate the merger agreement, limited the circumstances in which a termination fee would by payable by Angion to Elicio, reduced the
termination fee payable by Angion to Elicio, limited the circumstances in which Angion would be required to reimburse Elicio its expenses if the merger agreement is terminated under certain circumstances, including where the merger agreement is
terminated because Angion fails to obtain the stockholder vote to approve the transactions contemplated by the merger agreement, and modified the definition of Parent Material Adverse Effect and Company Material Adverse Effect.
On December 27, 2022, representatives of Cooley, Mintz Levin and
Goulston & Storrs PC (G&S), outside legal counsel to Elicio, held a telephonic meeting to discuss the open issues in the merger agreement, including with respect to the circumstances under which Elicio can terminate the merger
agreement, the circumstances in which a termination fee would be payable by Angion to Elicio, the termination fee payable by Angion to Elicio, the circumstances in which Angion would be required to reimburse Elicio its expenses if the merger
agreement is terminated under certain circumstances, including where the merger agreement is terminated because Angion fails to obtain the stockholder vote to approve the transactions contemplated by the merger agreement, and the definitions of
Parent Material Adverse Effect and Company Material Adverse Effect.
On December 28, 2022, Mintz Levin sent Cooley a revised draft of the
merger agreement.
On December 29, 2022, Cooley sent Mintz Levin an initial draft of
the note purchase agreement and form of note, which were subsequently negotiated and finalized.
On January 2, 2023, Dr. Venkatesan and Mr. Connelly had a
telephonic meeting to discuss the open points in the merger agreement.
On January 3, 2023, representatives of Cooley, Mintz Levin and
G&S held a telephonic meeting to discuss the open issues in the merger agreement, including with respect to the circumstances under which Elicio can terminate the merger agreement and expanded the circumstances in which a termination fee
would by payable by Angion to Elicio.
On January 4, 2023, Mintz Levin sent Cooley a revised draft of the
merger agreement. The parties continued to negotiate and exchange drafts of the merger agreement until it was finalized and subsequently executed on January 17, 2023.
On January 6, 2023, the parties executed an extension of
exclusivity, agreeing to extend the end of the exclusivity period from January 6, 2023 to January 17, 2023.
From January 6, 2023 to January 13, 2023, the parties continued to
work through open due diligence requests, exchanged drafts of each party’s disclosure schedules and drafts of the merger agreement and engaged in related discussions to finalize the transaction documents.
On January 13, 2023, the Angion Board held a videoconference
meeting, with Angion management and representatives of Oppenheimer and representatives of Cooley present, to review the terms of the Merger Agreement and related ancillary agreements, and to vote on whether to approve entry into the Merger
Agreement with Elicio. Representatives of Oppenheimer reviewed with the Angion Board Oppenheimer’s financial analyses of the Exchange Ratio. Representatives of Oppenheimer then delivered to the Angion Board the oral opinion of Oppenheimer,
which was subsequently confirmed in writing via a written opinion dated January 13, 2023, to the effect that, as of that date and based on and subject to various assumptions made, procedures followed, matters considered, and qualifications and
limitations on the scope of review undertaken by Oppenheimer as set forth in its written opinion, the Exchange Ratio in the Merger pursuant to the Merger Agreement was fair, from a financial point of view, to Angion, as more fully described
below in the section titled “—Opinion of Angion’s Financial Advisor.” Following the presentation by representatives of Oppenheimer, representatives of Cooley reviewed with the Board its fiduciary duties
applicable in connection with the strategic transaction process, including the proposed Merger, and the material terms of the draft Merger Agreement and related ancillary agreements. The Angion Board then discussed the potential transaction
with Elicio, and, after considering the matters discussed during that meeting and prior meetings of the Angion Board (for more information, see the section titled “—Reasons for the Merger”), the Angion Board unanimously (i) determined that
entry into the Merger Agreement and the Contemplated Transactions, were advisable and fair to, and in the best interests of, Angion and its stockholders; (ii) authorized, approved and declared advisable the Merger Agreement and the Contemplated
Transactions, including the issuance of shares of Common Stock to the stockholders of Elicio pursuant to the terms of the Merger Agreement, the change of control of Angion, and other actions contemplated by
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the Merger Agreement, (iii) determined to recommend, upon the terms and subject to
the conditions set forth in the Merger Agreement, that the stockholders of Angion vote to approve the Angion Stockholder Matters; and (iv) approved the Angion Support Agreements and the transactions contemplated thereby.
On January 17, 2023, representatives of Angion, Merger Sub and
Elicio executed the definitive Merger Agreement. Concurrently with the execution of the Merger Agreement, certain executive officers, directors and stockholders of Angion and Elicio delivered the Angion Support Agreements and Elicio Support
Agreements, respectively.
That same day, the execution of the Merger Agreement was publicly
announced before the Nasdaq Stock Market opened for the day.
At a meeting held on January 13, 2023, among other things, the
Angion Board unanimously (i) determined that the Merger and the other transactions and actions contemplated by the Merger Agreement (collectively, the Contemplated Transactions) are fair to, advisable and in the best interests of Angion and its
stockholders; (ii) authorized, approved and declared advisable the Merger Agreement and the Contemplated Transactions, including the issuance of shares of Angion common stock to the stockholders of Elicio pursuant to the terms of the Merger
Agreement, the change of control of Angion, and other actions contemplated by the Merger Agreement; (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Merger Agreement, that the stockholders of Angion
vote to approve the Angion Stockholder Matters (as defined in the section titled “Special Meeting of Angion Stockholders”); and (iv) approved the Angion Stockholder Support Agreements and the
transactions contemplated thereby.
The Angion Board considered the following reasons in reaching its
conclusion to approve the Merger Agreement, the Merger and the other Contemplated Transactions and to recommend that the stockholders of Angion vote to approve the Angion Stockholder Matters, all of which the Angion Board viewed as supporting
its decision to approve the Merger with Elicio:
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the Angion Board, with the assistance of its advisors, undertook a comprehensive and thorough process of reviewing and
analyzing potential strategic options, including remaining a standalone company pursuing a focused pipeline, a liquidation to distribute available cash, strategic mergers and acquisitions, including through a reverse merger, sale to a
third party and sale to insiders or a private investor, to identify the opportunity that would, in the Angion Board’s opinion, create the most value for Angion’s stockholders;
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the Angion Board believes that, as a result of arm’s length negotiations with Elicio, Angion and its representatives
negotiated the most favorable Exchange Ratio for Angion’s stockholders to which Elicio was willing to agree, and that the terms of the Merger Agreement include the most favorable terms to Angion in the aggregate to which Elicio was
willing to agree;
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the Angion Board’s belief, after a thorough review of strategic alternatives and discussions with Angion senior management,
representatives of its financial advisor and legal counsel, that the Merger is more favorable to Angion’s stockholders than the potential value that might have resulted from other strategic options available to Angion;
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the Angion Board’s belief, based in part on clinical and scientific diligence and an analysis process conducted over several
weeks by Angion’s management and reviewed with the Angion Board (which included numerous clinical and scientific diligence calls by Angion’s diligence team composed of internal and external subject matter experts, specializing in
pre-clinical science, clinical development, clinical operations, regulatory, manufacturing, intellectual property, and commercialization, which diligence team had access to and comprehensively reviewed Elicio’s virtual data room, with
Elicio’s management on Elicio’s programs, including its lead clinical development program ELI-002, and with feedback from such diligence calls from consultants and key opinion leaders), that with respect to Elicio’s product pipeline and
the potential market opportunity for Elicio’s product candidates, Elicio’s product candidates have the potential to create meaningful value for the stockholders of the combined company and an opportunity for Angion’s stockholders to
participate in the potential growth of the combined company;
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the Angion Board also reviewed with the management of Angion and the management of Elicio the current plans of Elicio for
developing ELI-002 and Elicio’s other product candidates to confirm the likelihood that
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the combined organization would possess sufficient financial resources to allow the
combined company’s management team to focus on the continued development and anticipated commercialization of those development candidates. The Angion Board also considered the possibility that the combined company would be able to take
advantage of the potential benefits resulting from the combination of Angion’s public company structure with Elicio’s business to raise additional funds in the future;
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the ability of Elicio to operate as a public company;
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the fact that the combined company will be led by an experienced industry chief executive officer and management team, many
members of which have extensive drug development, research and development, business and regulatory expertise, and a board of directors with representation from the current Angion Board and Elicio Board; and
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the oral opinion of Oppenheimer, subsequently confirmed in writing, to the Angion Board (in its capacity as such), to the
effect that, as of January 13, 2023, and based upon and subject to the various assumptions made, procedures followed, matters considered and qualifications and limitations on the review undertaken by Oppenheimer in preparing its opinion
set forth in its written opinion, the Exchange Ratio in the Merger pursuant to the Merger Agreement, was fair, from a financial point of view, to Angion, as more fully described below under the section captioned “The Merger–Opinion of Angion’s Financial Advisor.”
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The Angion Board also reviewed various reasons impacting the
financial condition, results of operations and prospects of Angion, including:
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the strategic alternatives to the Merger, including potential transactions that could have resulted from discussions that
Angion’s management conducted with other potential merger partners;
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the risks associated with Angion remaining a standalone company pursuing a limited pipeline and preclinical programs
including liquidity needs and cash-burn related to, among other things, funding Angion’s development pipeline;
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the risks associated with expected length of the program timelines of Angion’s current assets, including the expected length
of the ANG-3070 and ANG-3777 program timelines, and business development opportunities and the financing sources available to Angion based on such timelines;
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the risks associated with Angion’s ability to attract and retain talent;
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the risks associated with the need to obtain substantial amounts of financing to continue its operations and to continue the
development of its current programs if Angion were to remain an independent company; and
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the risks and delays associated with, and uncertain value and costs to Angion’s stockholders of, liquidating Angion,
including, without limitation, the uncertainties of continuing cash burn while contingent liabilities are resolved and uncertainty of timing of release of cash until contingent liabilities are resolved.
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The Angion Board also reviewed the terms and conditions of the
Merger Agreement and the Contemplated Transactions, as well as the safeguards and protective provisions included therein intended to mitigate risks, including:
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the initial estimated Exchange Ratio used to establish the number of shares of Angion common stock to be issued to Elicio’s
stockholders in the Merger was determined based on the relative valuations of Angion and Elicio, and thus the relative percentage ownership of Angion’s stockholders and Elicio’s stockholders immediately following the completion of the
Merger is subject to change based on the amount of Angion Net Cash at Closing to the extent it is greater than $31.5 million or less than $26.5 million, subject to certain exceptions as more fully described below under the caption “The Merger—Exchange Ratio”;
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a dollar-for-dollar adjustment to Angion Net Cash for amounts received by Angion (or which Angion is contractually entitled
to receive (subject to certain limitations)) for the sale of its legacy assets, if successful, as of the Closing Date;
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the limited number and nature of the conditions to Elicio’s obligation to consummate the Merger and the limited risk of
non-satisfaction of such conditions as well as the likelihood that the Merger will be consummated on a timely basis;
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the respective right of, and limitation on, Angion under the Merger Agreement to consider certain unsolicited Acquisition
Proposals under certain circumstances should Angion receive a Superior Offer;
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the reasonableness of the potential termination fee of $2 million, or $1 million in certain circumstances, and related
reimbursement of certain transaction expenses capped at $500,000, which could become payable by Angion to Elicio if the Merger Agreement is terminated in certain circumstances;
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the Support Agreements, pursuant to which certain directors, officers and stockholders of Angion and Elicio have agreed,
solely in their capacity as stockholders of Angion and Elicio, respectively, to vote all of their shares of Angion common stock or Elicio capital stock in favor of the approval or adoption, respectively, of the Merger Agreement and the
Contemplated Transactions;
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the agreement of Elicio to provide the written consent of Elicio’s stockholders necessary to adopt the Merger Agreement
thereby approving the Merger and the other Contemplated Transactions within three days of the Registration Statement becoming effective; and
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the belief that the terms of the Merger Agreement, including the parties’ representations, warranties and covenants, and the
conditions to their respective obligations, are reasonable under the circumstances.
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In the course of its deliberations, the Angion Board also
considered a variety of risks and other countervailing factors related to entering into the Merger, including:
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the $2 million, or $1 million in certain circumstances, termination fee payable by Angion to Elicio upon the termination of
the Merger Agreement in certain circumstances, the $1 million termination fee payable by Elicio to Angion upon the termination of the Merger Agreement in certain circumstances, up to $0.5 million in expense reimbursement payable by
Angion to Elicio or by Elicio to Angion, as applicable, in the event of a termination of the Merger Agreement in certain circumstances, and the potential effect of the fees in deterring other potential acquirers from proposing an
alternative transaction that may be more advantageous to Angion’s stockholders;
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the substantial expenses to be incurred in connection with the Merger, including the costs associated with any related
litigation;
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the likelihood of disruptive stockholder litigation following announcement of the Merger;
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the possible volatility, at least in the short term, of the trading price of Angion common stock resulting from the
announcement of the Merger;
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the risk that the Merger might not be consummated in a timely manner or at all and the potential adverse effect of the public
announcement of the Merger or delay or failure to complete the Merger on the reputation of Angion;
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the likely detrimental effect on Angion’s cash position, stock price and ability to initiate another process and to
successfully complete an alternative transaction should the Merger not be completed;
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the risk to Angion’s business, operations and financial results in the event that the Merger is not consummated, including
the diminution of Angion’s cash and the significant challenges associated with the need to raise additional capital through the public or private sale of equity securities;
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the early stage of development of Elicio’s product candidates, which, in the future, may not be successfully developed into
products that are marketed and sold;
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the strategic direction of the combined company following the completion of the Merger, which will be determined by a board
of directors initially comprised of a majority of the directors designated by Elicio; and
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various other risks associated with the combined company and the Merger, including those described in the section titled “Risk Factors” beginning on page 20 of this proxy statement/prospectus/information statement.
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The foregoing information and factors considered by the Angion
Board are the material factors considered by the Angion Board. In view of the wide variety of reasons considered in connection with its evaluation of the Merger and the complexity of these matters, the Angion Board did not find it useful to
attempt, and did not attempt, to
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quantify, rank or otherwise assign relative weights to these reasons. In
considering the reasons described above, individual members of the Angion Board may have given different weight to different reasons. The Angion Board conducted an overall analysis of the factors described above, including thorough discussions
with, and questioning of, Angion’s management team and the legal and financial advisors of Angion, and considered the reasons overall to be favorable to, and to support, its determination. In arriving at their respective recommendations, the
members of the Angion Board considered the interests of Angion’s executive officers and directors as described under the caption “The Merger—Interests of the Angion Directors and Executive Officers in the
Merger”.
The following discussion sets forth material factors considered by
the Elicio Board in reaching its determination to approve the terms and authorize the execution of the Merger Agreement for the purpose of implementing the Merger; however, it may not include all of the factors considered by the Elicio Board.
In light of the number and wide variety of factors considered in connection with its evaluation of the Merger Agreement, the Elicio Board did not consider it practicable to, and did not attempt to, quantify or otherwise assign relative weights
to the specific factors it considered in reaching its determination. The Elicio Board viewed its position and determinations as being based on all of the information available and the factors presented to and considered by it. In addition,
individual directors may have given different weight to different factors.
In the course of reaching its decision to approve the terms and
authorize the execution of the Merger Agreement for the purpose of consummating the Merger, the Elicio Board consulted with Elicio’s senior management and legal counsel, reviewed a significant amount of information and considered a number of
factors, including, among others:
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historical and current information concerning Elicio’s business, including its financial performance and condition,
operations, management and competitive position;
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Elicio’s prospects if it were to remain an independent privately held company, including its need to obtain additional
financing and the terms on which it would be able to obtain such financing, if at all;
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the Elicio Board’s belief that no alternatives to the Merger were reasonably likely to create greater value for Elicio
stockholders, after reviewing the various financing and other strategic options to enhance stockholder value that were considered by the Elicio Board;
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the cash resources of the combined company expected to be available at the Closing and the anticipated burn rate of the
combined organization;
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the broader range of investors to support the development of Elicio’s product candidates than it could otherwise obtain if it
continued to operate as a privately held company;
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the potential to provide its current stockholders with greater liquidity by owning stock in a public company;
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the expectation that the Merger with Angion would be a more time- and cost-effective means to access capital than other
options considered;
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the expectation that substantially all of Elicio’s employees, particularly its management, will serve in similar roles at the
combined organization;
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the fact that shares of Angion common stock issued to Elicio stockholders will be registered on a Form S-4 registration
statement and will become freely tradable for Elicio stockholders who are not affiliates of Elicio and who are not parties to the Lock-Up Agreements;
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the Support Agreements, pursuant to which certain directors, officers and stockholders of Angion and Elicio, respectively,
have agreed, solely in their capacity as stockholders of Angion and Elicio, respectively, to vote all of their shares of Elicio capital stock or Angion common stock in favor of the adoption or approval, respectively, of the Merger
Agreement;
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the ability to obtain a Nasdaq listing and comply with Nasdaq listing requirements;
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the terms and conditions of the Merger Agreement, including, without limitation, the following:
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the expected relative percentage ownership of Angion securityholders and Elicio securityholders
in the combined organization initially at the Closing and the implied valuation of Elicio based on Angion’s cash contribution to the combined organization;
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the parties' representations, warranties and covenants and the conditions to their respective
obligations;
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the limited number and nature of the conditions of the obligation of Angion to consummate the
Merger; and
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the likelihood that the Merger will be consummated on a timely basis.
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Elicio’s Board also considered a number of uncertainties and risks
in its deliberations concerning the Merger and the other transactions contemplated by the Merger Agreement, including the following:
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the risk that the potential benefits of the Merger Agreement may not be realized;
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the risk that future sales of common stock by existing Angion stockholders may cause the price of Angion common stock to
fall, thus reducing the value of the consideration received by Elicio stockholders in the Merger;
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the termination fee of $1 million and/or expense reimbursements of up to $500,000, payable by Elicio to Angion upon the
occurrence of certain events, and the
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the price volatility of Angion’s common stock, which may reduce the value of Angion common stock that Elicio stockholders
will receive upon the Closing;
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the potential reduction of Angion’s net cash prior to Closing;
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the possibility that Angion could under certain circumstances consider unsolicited acquisition proposals if superior to the
Merger;
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the possibility that the Merger might not be completed for a variety of reasons, such as the failure of Angion to obtain the
required stockholder vote, and the potential adverse effect on the reputation of Elicio and the ability of Elicio to obtain financing in the future in the event the Merger is not completed;
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the risk that the Merger might not be consummated in a timely manner or at all;
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the expenses to be incurred in connection with the Merger and related administrative challenges associated with combining the
organizations;
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the additional expenses that Elicio’s business will be subject to as a public company following the Closing to which it has
not previously been subject; and
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various other risks associated with the combined organization and the Merger,
including the risks described in the section titled “Risk Factors” beginning on page 20.
The Elicio Board weighed the benefits, advantages and
opportunities of a potential transaction against the uncertainties and risks described above, as well as the possible diversion of management attention for an extended period of time. After taking into account these and other factors, the
Elicio Board unanimously approved the terms and authorized execution of the Merger Agreement for the purpose of implementing the Merger.
Angion engaged Oppenheimer to render a written opinion (the
Opinion), to the Angion Board as to the fairness, from a financial point of view, to Angion of the Exchange Ratio in the proposed Merger pursuant to the Merger Agreement. Angion selected Oppenheimer because Oppenheimer is a nationally
recognized investment banking firm with substantial experience in transactions similar to the proposed Merger.
As part of Oppenheimer’s engagement, representatives of
Oppenheimer attended (via conference call) the meeting of the Angion Board held on January 13, 2023, at which the Angion Board evaluated the proposed Merger. At this meeting, Oppenheimer reviewed with the Angion Board Oppenheimer’s financial
analyses of the Exchange Ratio and rendered its opinion, as of such date and subject to the procedures followed, assumptions made, matters considered, and qualifications and limitations on the review undertaken by Oppenheimer as set forth in
its opinion, as to the fairness, from a financial point of view, to Angion of the Exchange Ratio in the proposed Merger pursuant to the Merger Agreement.
The description of the opinion set forth herein is qualified in
its entirety by reference to the full text of the opinion, which is attached as Annex B to this document and is incorporated herein by reference, and describes the
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procedures followed, assumptions made, matters considered, and qualifications and
limitations on the review undertaken by Oppenheimer in preparing its opinion. Oppenheimer’s opinion speaks only as of the date of the opinion. The opinion was for the information of, and was directed to, the Angion Board (in its capacity as
such) in connection with its consideration of the financial terms of the Merger. The opinion addressed the fairness, from a financial point of view, to Angion of the Exchange Ratio in the proposed Merger pursuant to the Merger Agreement. It did
not address the underlying business decision of the Angion Board to engage in the Merger or enter into the Merger Agreement. It does not constitute a recommendation to the Angion Board in connection with the Merger or a recommendation to any
holder of Angion common stock as to how to vote or act in connection with the Merger or any other matter, or whether to enter into a support agreement with either Angion or Elicio, nor does it constitute a recommendation on whether or not any
Angion stockholder should exercise any dissenters’ or appraisal rights that may be available to any Angion stockholder.
In connection with the opinion, Oppenheimer:
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reviewed a draft of the Merger Agreement labeled “Execution Version” sent to Oppenheimer on January 12, 2023;
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reviewed (i) audited financial statements of Elicio for the fiscal years ended December 31, 2020, and 2021, (ii) unaudited
financial statements of Elicio for the eleven-month period ended November 30, 2022, and (iii) unaudited cash balance as of December 31, 2022;
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reviewed financial forecasts and estimates relating to Elicio prepared by the senior management of Elicio as adjusted by the
management of Angion and approved for Oppenheimer’s use by the Angion Board (the Elicio Projections);
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held discussions with the senior management and advisors of each of Elicio and Angion with respect to the business and
prospects of each of Elicio and Angion, respectively;
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reviewed and analyzed certain publicly available financial data for companies that Oppenheimer deemed relevant in evaluating
Elicio;
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considered the financial terms of certain initial public offerings that Oppenheimer deemed relevant;
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reviewed other public information concerning Elicio;
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reviewed a certificate addressed to Oppenheimer from senior management of Angion which contained, among other things,
representations regarding the accuracy of the information, data and other materials (financial or otherwise) provided to, or discussed with, Oppenheimer by or on behalf of Angion; and
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performed certain other analyses, reviewed such other information and considered such other factors as Oppenheimer deemed
appropriate.
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In rendering the opinion, Oppenheimer relied upon and assumed,
without independent verification or investigation, the accuracy and completeness of all of the financial and other information provided to or discussed with Oppenheimer by Angion and its employees, representatives and affiliates or otherwise
reviewed by Oppenheimer. With respect to the Elicio Projections, Oppenheimer assumed, at the direction of Angion management and with the Angion Board’s consent, without independent verification or investigation, that the Elicio Projections were
reasonably prepared on bases reflecting the best available information, estimates and judgments of Elicio, as adjusted by Angion management, as to Elicio’s future financial condition and operating results. At the direction of representatives of
Angion, Oppenheimer also assumed that the final terms of the Merger Agreement would not vary materially from those set forth in the draft reviewed by it. Oppenheimer also assumed, with Angion’s consent, that the Merger would be consummated in
accordance with its terms without waiver, modification or amendment of any material term, condition or agreement and in compliance with all applicable laws and other requirements and that, in the course of obtaining the necessary regulatory or
third party approvals, consents and releases with respect to the Merger, no delay, limitation, restriction or condition would be imposed that would result in the disposition of any assets of Angion or Elicio or otherwise have an adverse effect
on Angion, Elicio or the Merger. Oppenheimer also assumed, with the consent of the Angion Board, that the Merger would qualify as a tax-free transaction. Oppenheimer also assumed that there were no material changes in the assets, liabilities,
financial conditions, results of operations, business or prospects of Elicio since the date of the last financial statements of Elicio that were made available to Oppenheimer. Oppenheimer neither made nor obtained any independent evaluations or
appraisals of the assets or liabilities, contingent or otherwise, of Angion or Elicio. For purposes of its opinion and its financial analyses
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underlying its opinion, Oppenheimer relied upon and assumed, at the direction of
Angion’s management with Angion’s consent, without independent verification, that (i) Angion had approximately 30,131,275 shares of common stock issued and outstanding on a fully-diluted basis assuming all outstanding in the money options and
warrants had converted and Elicio had approximately 349,036,558 shares of common stock issued and outstanding on a fully-diluted basis assuming all outstanding in the money options and warrants had converted, (ii) immediately following the
Merger, the pre-Merger equity holders of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding
shares of Angion common stock, in each case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. (iii) the Exchange Ratio was 0.0164 Angion shares for
each Elicio share, (iv) the value of Angion’s equity was equal to approximately $50.1 million, and (v) any adjustments to the Exchange Ratio pursuant to the Agreement would not be material to Oppenheimer’s analyses or its opinion.
The Elicio Projections provided to Oppenheimer were not prepared
with the expectation of public disclosure. All such information was based on numerous variables and assumptions that are inherently uncertain, including, without limitation, factors related to general economic and competitive conditions.
Accordingly, actual results could vary significantly from those set forth in the Elicio Projections. Oppenheimer assumed, based on discussions with management of Angion, that the Elicio Projections provided a reasonable basis upon which
Oppenheimer could form its opinion and Oppenheimer expressed no view as to any such information or the assumptions or bases therefor. Oppenheimer relied on all such information without independent verification or analysis and did not in any
respect assume any responsibility or liability for the accuracy or completeness thereof.
Oppenheimer did not express any opinion as to Angion’s underlying
valuation, future performance or long-term viability of Angion or the price at which Angion common stock would trade at any time. Oppenheimer did not express any view as to, and its opinion did not address, any terms or other aspects or
implications of the Merger (other than the Exchange Ratio to the extent expressly specified therein) or any aspect or implication of any other agreement, arrangement or understanding entered into in connection with the Merger or otherwise,
including, without limitation, the fairness of the amount or nature of the compensation resulting from the Merger to any individual officers, directors or employees of Angion, or class of such persons, relative to the Exchange Ratio or
otherwise. In addition, Oppenheimer expressed no view as to, and its opinion did not address, Angion’s underlying business decision to proceed with or effect the Merger nor did its opinion address the relative merits of the Merger as compared
to any alternative business strategies that might have existed for Angion or the effect of any other transaction in which Angion might have engaged. Oppenheimer’s opinion was necessarily based on the information available to Oppenheimer and
general economic, financial and stock market conditions and circumstances as they existed and could be evaluated by Oppenheimer on the date of its opinion. It should be understood that although subsequent developments may affect Oppenheimer’s
opinion, Oppenheimer does not have any obligation to update, revise or reaffirm its opinion. The credit, financial and stock markets had been experiencing unusual volatility and Oppenheimer expressed no opinion or view as to any potential
effects of such volatility on the Merger or Angion and Oppenheimer’s opinion did not address potential developments in any such markets. There was significant uncertainty as to the potential direct and indirect business, financial, economic and
market implications and consequences of the spread of the coronavirus and associated illnesses and the actions and measures that countries, central banks, international financing and funding organizations, stock markets, businesses and
individuals may take to address the spread of the coronavirus and associated illnesses including, without limitation, those actions and measures pertaining to fiscal or monetary policies, legal and regulatory matters and the credit, financial
and stock markets (collectively, the Pandemic Effects), and the Pandemic Effects could have a material impact on Oppenheimer’s analyses and its opinion.
Oppenheimer is not a legal, tax, regulatory or accounting advisor
and Oppenheimer relied on the assessments made by Angion and its other advisors with respect to such issues. Oppenheimer’s opinion did not address any legal, tax, regulatory or accounting matters. In addition, Oppenheimer’s opinion did not
constitute a solvency opinion or a fair value opinion, and Oppenheimer did not evaluate the solvency or fair value of Angion or Elicio under any federal or state laws relating to bankruptcy, insolvency, similar matters or otherwise.
In performing its analyses, Oppenheimer made numerous assumptions
with respect to the industry performance, general business, economic, market and financial conditions and other matters, which are beyond the control of Oppenheimer and Angion. Any estimates contained in the analyses performed by Oppenheimer
are not necessarily
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indicative of actual values or future results, which may be significantly more or
less favorable than suggested by these analyses. Additionally, estimates of the value of businesses or securities do not purport to be appraisals or to reflect the prices at which such business or securities might actually be sold. Accordingly,
these analyses and estimates are inherently subject to substantial uncertainty.
The following is a summary of the material financial analyses
presented by Oppenheimer to the Angion Board in connection with its opinion. The summary is not a complete description of the financial analyses underlying the opinion or the presentation made by Oppenheimer to the Angion Board, but summarizes
the material analyses performed and presented in connection with its opinion. The preparation of an opinion regarding fairness, from a financial point of view, is a complex analytic process involving various determinations as to appropriate and
relevant methods of financial analysis and the application of those methods to the particular circumstances. Therefore, an opinion regarding fairness, from a financial point of view, is not readily susceptible to partial analysis or summary
description. In arriving at its opinion, Oppenheimer did not attribute any particular weight to any analysis or factor that it considered, but rather made qualitative judgments as to the significance and relevance of each analysis and factor.
The financial analyses summarized below include information presented in tabular format. Accordingly, Oppenheimer believes that its analyses and the summary of its analyses must be considered as a whole and that selecting portions of its
analyses and factors or focusing on the information presented below in tabular format, without considering all analyses and factors or the full narrative description of the financial analyses, including the methodologies and assumptions
underlying the analyses, could create a misleading or incomplete view of the process underlying its analyses and opinion. The tables alone do not constitute a complete description of the financial analyses.
Selected Public Companies Analyses
Oppenheimer performed selected public companies analyses of Elicio
as described below. To perform these analyses, Oppenheimer used financial information and market price information as of market close on January 12, 2023. Certain financial data prepared by Oppenheimer, and as referenced in the tables presented
below, may not correspond to the data presented in the historical financial statements of Elicio as a result of the different periods, assumptions and method used by Oppenheimer to compute the financial data presented. No company used as a
comparison in the following selected public companies analyses is identical or directly comparable to Elicio. Accordingly, an analysis of these results is not purely mathematical. Rather, it involves complex considerations and judgments
concerning differences in financial and operating characteristics of the companies involved.
Using publicly available information, Oppenheimer compared the
financial performance, financial condition and market performance of Elicio to the following eleven selected publicly traded United States Phase 1 or Phase 2 platform biologics oncology companies with total debt (excluding convertible debt)
less than 10% of market capitalization and market capitalizations under $500 million (no other criteria were considered in selecting other public companies):
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ALX Oncology Holdings Inc.
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BioAtla, Inc.
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Sutro Biopharma, Inc.
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PDS Biotechnology Corporation
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Aadi Bioscience, Inc.
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Gritstone bio, Inc.
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Omega Therapeutics, Inc.
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Biomea Fusion, Inc.
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Acrivon Therapeutics, Inc.
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Cue Biopharma, Inc.
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Kinnate Biopharma Inc.
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Oppenheimer reviewed enterprise values of the selected public
companies, calculated as equity values based on closing stock prices on January 12, 2023 plus debt, less cash and cash equivalents, including marketable securities
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and short-term investments. Financial data of the selected companies were based on
public filings and other publicly available information. The enterprise values for the selected companies were as follows: $240.7 million (ALX Oncology); $27.5 million (BioAtla); $191.3 million (Sutro Biopharma); $159.3 million (PDS
Biotechnology); $183.7 million (Aadi Bioscience); $154.2 million (Gritstone bio); $392.7 million (Omega Therapeutics); $78.8 million (Biomea Fusion); $117.6 million (Acrivon Therapeutics); $97.5 million (Cue Biopharma); and $49.9 million
(Kinnate Biopharma). The median enterprise value observed for the selected companies was $154.2 million.
Oppenheimer applied the median selected ranges of the enterprise
values derived from the selected companies, as adjusted by +/- 10%, then added Elicio’s net cash of $7.8 million as of December 31, 2022 (based on internal estimates provided by Elicio management and approved for Oppenheimer’s use by Angion’s
management), to derive an equity value reference range of $147 million to $177 million.
Discounted Cash Flow Analysis
Oppenheimer conducted a discounted cash flow analysis, which is
designed to imply a potential current value of Elicio by calculating the estimated present value of the standalone after-tax free cash flows that Elicio management forecasted to be generated, as adjusted by Angion’s management, during the
calendar years ending December 31, 2023 through December 31, 2039. Oppenheimer calculated terminal values for Elicio by applying a range of increasing perpetuity rates of 0.0% to 2.0% (which were chosen based on Oppenheimer’s professional
judgment) to calendar year 2039 unlevered free cash flow in order to derive a range of terminal values for Elicio. The cash flow and terminal values were then discounted to present value using discount rates ranging from 28.5% to 31.5%, which
were based on venture capital rates of return for companies in a similar stage in their development (bridge/initial public offering – stage financing) and selected based on Oppenheimer’s professional judgment. After adding Elicio’s net cash of
$7.8 million as of December 31, 2022 (based on internal estimates provided by Elicio management and approved for Oppenheimer’s use by Angion’s management), Oppenheimer derived an approximate implied total equity value of Elicio of $561 million
to $773 million.
Selected Precedent Initial Public Offering
Analysis
Oppenheimer performed selected precedent initial public offering
analyses of Elicio as described below. Certain financial data prepared by Oppenheimer, and as referenced in the tables presented below, may not correspond to the data presented in the historical financial statements of Elicio as a result of the
different periods, assumptions and method used by Oppenheimer to compute the financial data presented. No initial public offering used as a comparison in the following selected precedent initial public offering analyses is identical or directly
comparable to Elicio. Accordingly, an analysis of these results is not purely mathematical. Rather, it involves complex considerations and judgments concerning differences in financial and operating characteristics of the companies involved.
Using publicly available information, Oppenheimer compared the
financial performance, financial condition and market performance of Elicio to the following four selected precedent initial public offerings of publicly traded United States Phase 1 or Phase 2 platform oncology companies with fully-diluted
initial public offering post-money equity values of less than $500 million since January 12, 2020 (no other criteria were considered in selecting precedent initial public offerings):
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Acrivon Therapeutics, Inc.
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Xilio Therapeutics, Inc.
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Immuneering Corporation
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Werewolf Therapeutics, Inc.
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Oppenheimer reviewed adjusted implied total enterprise values of
the selected precedent initial public offerings, calculated as fully-diluted initial public offering post-money equity value less pro forma net debt , adjusted to reflect the performance of the SPDR S&P Biotech ETF (XBI) Index from the date
of such company’s initial public offering to January 12, 2023. Financial data of the selected precedent initial public offerings were based on public filings and other publicly available information. The adjusted implied total enterprise values
for the selected precedent initial public offerings were as follows: $218.1 million (Acrivon Therapeutics); $125.4 million (Xilio Therapeutics); $129.8 million (Immuneering); and $104.2 million (Werewolf Therapeutics). The median adjusted
implied total enterprise value observed for the selected precedent initial public offerings was $127.6 million.
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Oppenheimer applied the median selected ranges of the adjusted
implied total enterprise values derived from the selected precedent initial public offerings, as adjusted by +/- 10%, then added Elicio’s net cash of $7.8 million as of December 31, 2022 (based on internal estimates provided by Elicio
management and approved for Oppenheimer’s use by Angion’s management), to derive an equity value reference range of $123 million to $148 million.
Implied Exchange Ratio Range Analysis
Oppenheimer utilized the range of implied equity values of Elicio
based on the Selected Public Companies Analyses, the Discounted Cash Flow Analysis and the Selected Precedent Initial Public Offering Analysis to calculate the implied equity values for Elicio. Oppenheimer also calculated the implied number of
shares of Angion common stock that would be issued to Elicio stockholders in the Merger based on the implied equity value of Angion to the implied equity value of Elicio based on the foregoing analytical methods.
Based on the Selected Public Companies Analyses of equity
valuations of each of Angion and Elicio, Oppenheimer calculated that Angion equity value represents approximately 22.0% to 25.5% of the combined company equity value; based on the Discounted Cash Flow Analysis of equity valuation of each of
Angion and Elicio, Oppenheimer calculated that Angion equity value represents approximately 6.1% to 8.2% of the combined company equity value; and based on the Selected Precedent Initial Public Offering Analysis of equity valuations of each of
Angion and Elicio, Oppenheimer calculated the Angion equity value represents approximately 25.3% to 29.0% of the combined company equity value; in each case, as compared to the 34.5% that Angion equity value represents in the Merger.
Miscellaneous
In the two years preceding the date of its opinion, Oppenheimer
provided investment banking, financial advisory and/or other financial services to Elicio, including having been engaged as an underwriter to Elicio in its planned initial public offering in March 2021 for which Oppenheimer was not paid any
fees because Elicio’s planned initial public offering was subsequently withdrawn. In addition, and in the two years preceding the date of its opinion, Oppenheimer provided investment banking, financial advisory and/or other financial services
to Angion, including having acted as co-lead manager to Angion in its initial public offering in February 2021 for which Oppenheimer was paid approximately $644,000. Oppenheimer may in the future provide investment banking and financial
advisory services to Angion or Elicio and may receive compensation for those services. As Angion was aware and as was disclosed to the Angion Board on January 13, 2023 in connection with rendering the opinion of Oppenheimer, Daniel Geffken, the
Interim Chief Financial Officer and a member of the Elicio Board, was also the Chief Financial Officer for OPY Acquisition Corp. I (OPY1), and the sponsor of OPY1 was an affiliate of Oppenheimer. The decision to enter into the Merger Agreement
was solely that of the Angion Board. The Angion Board believes it is able to actively monitor any potential conflicts of interest arising from Daniel Geffken’s role as Interim Chief Financial Officer of Elicio and a member of the Elicio Board
and his role as Chief Financial Officer of OPY1, whose sponsor was an affiliate of Oppenheimer. The Angion Board determined on January 13, 2023 that Daniel Geffken’s relationship with Oppenheimer did not represent a conflict of interest or
misalignment of incentives with investors. Oppenheimer’s opinion and financial analyses were only one of a number of factors considered by the Angion Board in evaluating the Merger and should not be viewed as determinative of the views of the
Angion Board or management of Angion with respect to the Merger or the Exchange Ratio in the Merger. Under the terms of Oppenheimer’s engagement, Angion paid Oppenheimer for its opinion in connection with the Merger a fee of $500,000, which
became payable upon delivery of Oppenheimer’s opinion (creditable against the fee payable upon consummation of the Merger), and has agreed to pay Oppenheimer a fee of approximately $1,300,000 upon the consummation of the Merger. In addition,
Angion has agreed to reimburse Oppenheimer for its expenses, including fees and expenses of counsel, and to indemnify Oppenheimer and related parties against liabilities, including liabilities under federal securities laws, arising out of or in
connection with the services rendered and to be rendered by Oppenheimer under its engagement.
As a matter of course, neither Angion nor Elicio publicly
discloses forecasts, internal projections as to future performance, revenues, earnings or other results of operations due to the inherent unpredictability and subjectivity of the underlying assumptions and projections. However, in connection
with the proposed transaction, Elicio’s management prepared a preliminary internal financial forecast for Elicio, which Angion’s management adjusted to reflect certain assumptions applicable to Elicio’s assets as well as to Elicio’s expenses
based on industry metrics consistent with the experience and judgment of Angion’s management and the Angion Board (such projections, the
117
Financial Projections). The Financial Projections were made available to the
Angion Board, which then directed Oppenheimer to use the Financial Projections in its financial analyses. Oppenheimer relied on the Financial Projections in its financial analyses undertaken in connection with the rendering of its opinion (see
“The Merger—Opinion of Angion’s Financial Advisor”). A summary of the Financial Projections is set forth below.
The information set forth below is included solely to give Angion
stockholders access to the Financial Projections relating to Elicio’s assets that were provided to the Angion Board in connection with its evaluation of the Merger and that were relied upon by Oppenheimer in connection with the rendering of its
opinion discussed under the section titled “The Merger— Opinion of Angion’s Financial Advisor.” The Financial Projections as prepared by Elicio and adjusted by Angion’s management, were provided to
Oppenheimer by Angion and reflected the judgment of Angion’s management in applying adjustments to reflect additional costs for research and development and selling, general and administrative costs. The inclusion of information about such
projections in this proxy statement/prospectus/information statement should not be regarded as an indication that Angion or any other recipient of this information considered, or now considers, this information to be predictive of actual future
results, nor should it be deemed an admission or representation by Angion, Oppenheimer, Elicio or any of their respective officers, directors, affiliates, advisors or other representatives with respect to such projections. The information from
the Financial Projections should be evaluated, if at all, in conjunction with the historical financial statements and other information regarding Elicio in this proxy statement/prospectus/information statement.
The Financial Projections were prepared solely for internal use
and in connection with Oppenheimer’s work, do not take into account any circumstances or events occurring after the date they were prepared and are subjective in many respects. As a result, the Financial Projections are susceptible to multiple
interpretations and periodic revisions based on actual experience and business developments. Although Elicio and Angion believe their respective assumptions to be reasonable, all financial projections are inherently uncertain, and Angion
expects that differences will exist between actual and projected results. Although presented with numerical specificity, the Financial Projections reflect numerous variables, estimates and assumptions made by Elicio’s and Angion’s respective
management at the time the underlying information and forecasts were prepared, and also reflect general business, economic, market and financial conditions and other matters, including the ability to obtain regulatory approvals and the expected
timing thereof, all of which are difficult to predict and many of which are beyond the control of any party. There can be no assurance that the varying estimates and assumptions made in preparing the Financial Projections will prove accurate or
that any of the Financial Projections will be realized. Neither Angion nor Elicio can make any assurances that the Financial Projections will be realized or that the combined company’s future financial results will not materially vary from the
Financial Projections. In particular, the Financial Projections should not be utilized as public guidance. For a description of these and other risks related to the Financial Projections, see “Risks Related to
the Merger — The Financial Projection included in the section titled “The Merger — Certain Unaudited Financial Projections,” which were considered by the Angion Board in evaluating the Merger and used by Oppenheimer in rendering its opinion
and performing its related financial analyses, reflect numerous variables, estimates and assumptions and are inherently uncertain. If any of these variables, estimates and assumptions prove to be wrong, such as the assumptions relating to the
approval of Elicio’s product candidates, the actual results for Elicio’s business may be materially different from the results reflected in the Financial Projections.”
The Financial Projections were prepared for internal use and were
not prepared with a view toward public disclosure or with a view toward compliance with published guidelines of the SEC regarding projections and GAAP. The Financial Projections include total adjusted revenue, earnings before interest and tax
(EBIT) and unlevered free cash flow. Such non-GAAP measures as used by Angion may not be directly comparable to similarly titled measures used by other companies and should not be considered in isolation from, or as a substitute for, financial
information presented in accordance with GAAP. The SEC rules, which otherwise would require a reconciliation of a non-GAAP financial measure to a GAAP financial measure, do not apply to non-GAAP financial measures provided to a board of
directors or financial advisors in connection with a proposed business combination transaction such as the Contemplated Transactions, if the disclosure is included in a document such as this proxy statement/prospectus/information statement to
comply with requirements under state laws, including case law. The Financial Projections were provided to Oppenheimer in order for it to render its opinion to the Angion Board in connection with its consideration of the Contemplated
Transactions and other strategic alternatives, and Angion believes Angion has an obligation to disclose such projections under Delaware law, including applicable case law, in order to provide a fair summary of certain of the financial analysis
and substantive work of Oppenheimer and because the Financial Projections were relied upon by the Angion Board in connection with its consideration of the Contemplated Transactions and other strategic alternatives. In addition, reconciliations
of non-GAAP financial
118
measures to GAAP financial measures were not provided to or relied upon by the
Angion Board or Oppenheimer in connection with the Merger. Accordingly, Angion has not provided a reconciliation of the financial measures included in the Financial Projections to the relevant GAAP financial measures. The Financial Projections
may differ from published analyst estimates and forecasts and do not take into account any events or circumstances after the date they were prepared, including the announcement of the Contemplated Transactions.
The Financial Projections included certain assumptions relating
to, among others things, Angion’s and Elicio’s respective expectations, which may not prove to be accurate, relating to the business, earnings, cash flow, assets, liabilities and prospects of Elicio, industry metrics such as target indications
and size of the addressable population and the regulatory and commercial probability of success and revenue and expenses adjusted on the basis thereof.
The Financial Projections were prepared using the following
material assumptions: (i) a first regulatory approval in the United States for ELI-002 for the treatment of PDAC in 2027, followed by subsequent approvals in the United States for CRC in 2033, and NSCLC in 2034 and additional approvals in
Europe and Japan expected in PDAC in 2032 and 2033, for CRC in 2034 and 2035, and for NSCLC in 2035 and 2036; (ii) peak revenues to occur in 2038, as 2039 is assumed as the year for loss of exclusivity for ELI-002 in both the United States and
Europe based on the current intellectual property portfolio; (iii) revenue projections based on the projected incidence of PDAC, CRC and NSCLC multiplied by the estimated cost per patient treatment and the expected market penetration
(accounting for the complexity of the disease etiologies); (iv) projected treatment course price of $170,000 in the United States, $100,000 in Europe and $170,000 in Japan; and (v) product exclusivity for a period of 12 years, which Angion and
Elicio believe is consistent with current exclusivity for biological products.
Additionally, the preliminary internal financial forecast prepared
by Elicio included material estimates of the number of patients treated, market share and treatment course price, based on a year-by-year basis, taking into account estimates of population growth, the ability to capture market share and
economies of scale. For PDAC, Elicio assumed United States, European Union and Japan incidences of approximately 64,000 patients, 73,000 patients and 43,000 patients, respectively, with 97%, 45-80% (pending specific country) and 67% of these
patients in the United States, European Union and Japan, respectively, being tested for KRAS and 93% of these tested patients possessing a KRAS mutation. Of these KRAS-positive patients, approximately 22,000, 7,000 and 4,000 of these patients
in the United States, European Union and Japan, respectively, present with resectable early/local disease, and just over-third receive adjuvant treatment, resulting in an eligible patient population of approximately 8,000, 2,500 and 1,500 of
these patients in the United States, European Union and Japan, respectively, receive adjuvant treatment. All of these patients are considered eligible patients for ELI-002, and Elicio has assumed that approximately 80%, 67% and 67% of that
eligible patient population in the United States, European Union and Japan, respectively, will receive ELI-002 in the peak year 2038 based on unmet need, accessibility and alternative options. For CRC, Elicio assumed United States, European
Union and Japan incidences of approximately 147,000 patients, 199,000 patients and 130,000 patients, respectively, with 80%, 74-85% (pending specific country) and 74% of these patients in the United States, European Union and Japan,
respectively, being tested for KRAS and 41% of these tested patients possessing a KRAS mutation. Of these KRAS-positive patients, approximately 28,000, 41,257 and 25,000 of these patients in the United States, European Union and Japan,
respectively, present with resectable early/local disease, and 8,000, 6,800, and 4,000 of these KRAS-positive patients receive adjuvant treatment in the United States, European Union and Japan, respectively, resulting in an eligible patient
population of approximately 7,000, 6,400, and 3,700 patients for ELI-002 in the United States, European Union and Japan, respectively. All of these patients are considered eligible patients for ELI-002, and Elicio has assumed that approximately
70%, 81% and 81% of that eligible patient population in the United States, European Union and Japan, respectively, will receive ELI-002 in the peak year 2038 based on unmet need, accessibility and alternative options. For NSCLC, Elicio assumed
United States, European Union and Japan incidences of approximately 187,000 patients, 151,000 patients and 94,000 patients, respectively, with 80%, 60-75% (pending specific country) and 55% of these patients in the United States, European Union
and Japan, respectively, being tested for KRAS and 27%, 26% and 13% of these tested patients in the United States, European Union and Japan, respectively, possessing a KRAS mutation. Of these KRAS-positive patients, approximately 13,000, 4,900
and 488 of these patients in the United States, European Union and Japan, respectively, present with resectable early/local disease, and approximately 6,600, 3,500 and 470 of these patients in the United States, European Union and Japan,
respectively, receive adjuvant treatment. The vast majority of these patients are considered eligible patients for ELI-002 and Elicio assumed that approximately 47%, 39% and 16.5% of that eligible patient population in the United States,
European Union and Japan, respectively, will receive ELI-002 in the peak year 2038 based on unmet need, accessibility and alternative options. In addition to the growth inherent with launching new products that capture market share at
decreasing annual rates over a period of time, which was assumed to be three years to reach peak
119
penetration for each product, growth in revenues were also driven by the
assumption that the total addressable market for each product (based on the assumption that this KRAS-targeted patient segment would still be under-served by the time of ELI-002’s launches, and as such, would face no to low competition, this
unmet need would remain high, and product quality attractiveness would be high), comprising population growth, changes in the incidence of the diseases and that pricing would be remain flat until launch with a 4% annual increase thereafter.
Following discussions with Elicio’s management, Angion’s
management made adjustments to the preliminary internal financial forecast prepared by Elicio with respect to the expenses and depreciation and amortization of assets. These adjustments were based on metrics deemed applicable to Elicio’s
business by Angion’s management, and which were consistent with the experience and judgement of Angion’s management as well as the Angion Board. Angion’s management and the Angion Board have extensive experience in the development of product
candidates, from preclinical stages to regulatory approval in the United States well as in foreign jurisdictions, and the expenses and depreciation and amortization of assets associated with the development of product candidates. The material
differences and reasons for such differences in the Financial Projections, as adjusted by Angion’s management, compared to the preliminary internal financial forecast prepared by Elicio, are:
|
•
|
internal research and development headcount costs were adjusted upwards by $10 million in 2026 and adjusted to grow 5%
year-over-year, for a total increase of $196 million through 2039, to account for projected increases in headcount costs;
|
|
•
|
general and administrative expenses were adjusted upwards to account for 30%, rather than 20%, of operating expenses to align
with the historical expense distribution of Angion;
|
|
•
|
research and development expenses were separated based on those occurring within the United States (60%) and those occurring
outside the United States (40%) to reflect Elicio’s revenue projection within the United States (60%) and outside the United States (40%);
|
|
•
|
annual capital expenditures of $200,000 were added to align with anticipated capital expenditure needs;
|
|
•
|
depreciation of property, plant and equipment were factored in (for legacy property, plant and equipment, $340,000;
|
|
•
|
for first 5 years, then $0 thereafter, and for new property, plant and equipment, $4,000 each year); and
|
|
•
|
net operating loss balances were added to reflect amortization of the research and development costs.
|
Estimates of the number of patients treated, market share and
treatment were all determined on a year-by-year basis, taking into account estimates of population growth, the ability to capture market share, and economies of scale. In addition to the growth inherent with launching new products that capture
market share at decreasing annual rates over a period of time, which was assumed to be seven years to reach peak penetration for each product, growth in revenues was also driven by the assumption that the total addressable market for each
product, comprising the growth in U.S. population, changes in incidence of the diseases, and pricing would be unchanged.
The Financial Projections were prepared by, and are the
responsibility of, Angion’s management, based upon the information preliminarily provided by Elicio. Moss Adams LLP has not audited, reviewed, examined, compiled nor applied agreed-upon procedures with respect to the Financial Projections, and
accordingly, Moss Adams LLP does not express an opinion or give any other form of assurance with respect thereto. The Moss Adams LLP reports included and incorporated by reference in this proxy statement/prospectus/information statement relate
to the previously issued financial statements of Angion. The reports do not extend to the Financial Projections and should not be read to do so.
Angion stockholders are urged to review the section titled “Risk Factors” of this proxy statement/prospectus/information statement for a description of the risks relating to the Merger, Elicio’s business and Angion’s business. Angion stockholders are also urged to
review Angion’s most recent SEC filings. Angion stockholders should also read the section titled “Cautionary Note Concerning Forward-Looking Statements” of this proxy statement/prospectus/information
statement for additional information regarding the risks inherent in forward-looking information such as the Financial Projections.
The Financial Projections extend for a period through 2039 and the
risks and uncertainties regarding the Financial Projections, including the potential for adverse developments such as delays in obtaining or failure to obtain regulatory approvals and additional competition or changes in the competitive or
regulatory landscape, increase each
120
successive year, but represent the extension of reasonable assumptions throughout
the forecast period. The decision to prepare projections until 2039 was based on Elicio’s management’s assessment that such time period would represent the time period for product exclusivity after which Elicio assumes ELI-002 will be exposed
to biosimilar or generic competition and subsequent loss of product sales.
In light of the foregoing factors and the
uncertainties inherent in financial projections, stockholders are cautioned not to place undue reliance, if any, on the Financial Projections.
The Financial Projections included below are not being included
herein to influence Angion’s stockholders’ decision whether to vote in favor of any proposal contained in this proxy statement/prospectus/information statement. In light of the foregoing factors and the uncertainties inherent in the Financial
Projections, stockholders are cautioned not to place undue, if any, reliance on the Financial Projections included in this proxy statement/prospectus/information statement.
Financial Projections
($ in millions)
|
|
| |
2023
|
| |
2024
|
| |
2025
|
| |
2026
|
| |
2027
|
| |
2028
|
| |
2029
|
| |
2030
|
| |
2031
|
| |
2032
|
| |
2033
|
| |
2034
|
| |
2035
|
| |
2036
|
| |
2037
|
| |
2038
|
| |
2039
|
|
Total Global Revenue(1)
|
| |
$0
|
| |
$0
|
| |
$0
|
| |
$0
|
| |
$62
|
| |
$457
|
| |
$806
|
| |
$964
|
| |
$1,031
|
| |
$1,154
|
| |
$1,416
|
| |
$2,155
|
| |
$3,248
|
| |
$4,184
|
| |
$4,654
|
| |
$5,011
|
| |
$5,278
|
|
EBIT(2)
|
| |
$(11)
|
| |
$(18)
|
| |
$(22)
|
| |
$(85)
|
| |
$(104)
|
| |
$193
|
| |
$483
|
| |
$518
|
| |
$524
|
| |
$531
|
| |
$625
|
| |
$1,127
|
| |
$1,930
|
| |
$2,484
|
| |
$2,724
|
| |
$2,925
|
| |
$3,113
|
|
Unlevered
Free Cash
Flow(3)
|
| |
$(9)
|
| |
$(18)
|
| |
$(23)
|
| |
$(89)
|
| |
$(103)
|
| |
$221
|
| |
$417
|
| |
$401
|
| |
$412
|
| |
$415
|
| |
$490
|
| |
$879
|
| |
1,477
|
| |
$1,864
|
| |
$2,032
|
| |
$2,197
|
| |
$2,370
|
|
(1)
|
Equal to total worldwide net sales.
|
|
(2)
|
Equal to gross profit less research and development expenses, sales and marketing expense, and general and administrative
expense.
|
|
(3)
|
Unlevered free cash flow is defined as EBIT, less taxes, plus depreciation and amortization, less capital expenditures, less
interest income and less changes in net working capital.
|
In considering the recommendation of the Angion Board with respect
to the approval of the Merger Agreement, the Merger and the issuance of shares of Angion common stock as contemplated by the Merger Agreement, and the Angion Stockholder Matters, Angion’s stockholders should be aware that certain members of the
Angion Board and current and former executive officers of Angion have interests in the Merger that may be different from, or in addition to, the interests of Angion’s stockholders.
On January 13, 2023, the Angion Board adopted the Angion Biomedica
Corp. Retention Bonus Plan (Retention Bonus Plan). Participants in the Retention Bonus Plan include Jay Venkatesan, M.D., Angion’s President, Chief Executive Officer and Chairman, and Jennifer Rhodes, Angion’s Executive Vice President, Chief
Business Officer, General Counsel, Chief Compliance Officer and Secretary. The Retention Bonus Plan provides for the payment of a cash retention bonus equal to 100% of a participant’s base salary, 65% of which becomes earned and payable upon
the occurrence of a corporate triggering event (defined to include a change in control (as defined in Angion’s 2021 Incentive Award Plan), a reverse merger or a dissolution) and 35% of which becomes earned and payable three months after the
occurrence of such corporate triggering event, subject in each case to earlier payment upon the occurrence of a qualifying termination of the participant’s employment by Angion without “cause” or by the participant for “good reason,” each as
defined in the Retention Bonus Plan. Upon the earlier of a corporate triggering event or a qualifying termination, time-based equity awards will vest in full, the post-termination exercise period of options held by the participant will be
extended by four years (but no later than the original term of the option) and participants will receive an additional lump sum cash payment (approximately $1,464,000 in the case of Dr. Venkatesan and $642,000 in the case of Ms. Rhodes, in each
case less applicable withholding). Participants will no longer have the right to receive any payments under Angion’s Executive Separation Benefits Plan. The receipt of payments under the Retention Bonus Plan is subject to the execution of a
general release of claims by the participant. Concurrently, the Angion Board approved modifications of the Angion stock options held by Gregory Curhan, Angion’s Chief Financial Officer, such that, upon the earlier of a corporate triggering
event or a qualifying termination and subject to Mr. Curhan’s execution of a general release of claims, one option granted in 2022 will vest in full and the post-termination exercise period of all options will be extended by four years (but no
later than the original term of the option).
121
The Angion Board was aware of these potential conflicts of
interest and considered them, among other matters, in reaching their respective decisions to approve the Merger Agreement and the Merger, and to recommend, as applicable, that Angion’s stockholders approve the proposals to be presented to
Angion’s stockholders for consideration at the Angion special meeting as contemplated by this proxy statement/prospectus/information statement.
Ownership Interests
As of December 31, 2022, Angion’s named executive officers and
directors and such directors affiliated funds beneficially owned, in the aggregate, approximately 19.3% of the shares of Angion common stock. Certain Angion officers and directors, and their affiliates, have also entered into the Support
Agreements in connection with the Merger. For a more detailed discussion of the Support Agreements, please see the section titled “Agreements Related to the Merger” beginning on page 156
of this proxy statement/prospectus/information statement.
Angion Options
As of December 31, 2022, Angion’s named executive officers and
directors collectively owned unvested stock options to purchase 1,058,612 shares of Angion common stock and vested stock options to purchase 2,231,678 shares of Angion common stock, for a total of option to purchase 3,290,290 shares of Angion
common stock. All outstanding and unexercised options to purchase shares of Angion common stock will remain effective and outstanding.
Angion options are subject to “double-trigger” accelerated vesting
upon an involuntary termination without “cause” (not including death or disability) or resignation for “good reason,” in either case, on or within 12 months following the occurrence of a “change in control” (which will occur upon the Closing of
the Merger), in accordance with the terms of Angion’s previously disclosed 2011 Equity Incentive Plan, as amended (Amended 2011 Plan). The definitions of “cause” and “good reason” applicable to each executive officer are contained in their
respective employment related agreements or the Amended 2011 Plan and have not been modified in connection with the transactions. Options held by Dr. Venkatesan and Ms. Rhodes are subject to accelerated vesting under the Retention Bonus Plan,
and one option granted to Mr. Curran in 2022 will vest in full and the post-termination exercise period of all options will be extended by four years (but no later than the original term of the option), in each case as described above.
The following table presents certain information concerning the
outstanding Angion stock options held by each of Angion’s named executive officers and directors as of December 31, 2022:
|
|
| |
Option Awards
|
||||||||||||
|
Name
|
| |
Vesting
Commencement
Date(1)
|
| |
Number of
Securities
Underlying
Unexercised
Options
Exercisable
(#)
|
| |
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
(#)
|
| |
Option
Exercise
Price
($)
|
| |
Option
Expiration
Date
|
|
Jay R. Venkatesan, M.D.
|
| |
5/1/2018(2)
|
| |
934,400
|
| |
—
|
| |
5.89
|
| |
5/1/2028
|
| |
6/18/2020
|
| |
77,791
|
| |
46,675
|
| |
7.77
|
| |
6/17/2030
|
||
| |
2/5/2021
|
| |
82,005
|
| |
96,915
|
| |
16.00
|
| |
2/4/2031
|
||
| |
3/3/2022(5)
|
| |
272,500
|
| |
487,500
|
| |
1.94
|
| |
3/2/2032
|
||
|
Itzhak Goldberg, M.D.
|
| |
12/19/2018(3)
|
| |
40,600
|
| |
—
|
| |
6.05
|
| |
1/21/2029
|
| |
6/18/2020
|
| |
38,895
|
| |
23,338
|
| |
7.77
|
| |
6/17/2030
|
||
| |
2/5/2021
|
| |
32,088
|
| |
37,924
|
| |
16.00
|
| |
2/4/2031
|
||
|
Jennifer J. Rhodes
|
| |
2/14/2020(3)
|
| |
113,040
|
| |
3,647
|
| |
9.51
|
| |
2/13/2030
|
| |
6/18/2020
|
| |
36,464
|
| |
21,879
|
| |
7.77
|
| |
6/17/2030
|
||
| |
2/5/2021
|
| |
32,088
|
| |
37,924
|
| |
16.00
|
| |
2/4/2031
|
||
| |
3/2/2022(5)
|
| |
132,812
|
| |
142,188
|
| |
1.99
|
| |
3/1/2032
|
||
|
Victor Ganzi, J.D.
|
| |
2/14/20200(6)
|
| |
25,930
|
| |
12,965
|
| |
9.51
|
| | |
| |
3/8/2021(7)
|
| |
15,000
|
| |
—
|
| | | | ||||
| |
6/9/2022(7)
|
| |
—
|
| |
15,000
|
| | | | ||||
122
|
|
| |
Option Awards
|
||||||||||||
|
Name
|
| |
Vesting
Commencement
Date(1)
|
| |
Number of
Securities
Underlying
Unexercised
Options
Exercisable
(#)
|
| |
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
(#)
|
| |
Option
Exercise
Price
($)
|
| |
Option
Expiration
Date
|
|
Allen Nissenson, M.D.
|
| |
2/14/2020(6)
|
| |
25,930
|
| |
12,965
|
| |
9.51
|
| | |
| |
3/8/2021(7)
|
| |
15,000
|
| |
—
|
| | | | ||||
| |
6/9/2022(7)
|
| |
—
|
| |
15,000
|
| | | | ||||
|
Gilbert Omenn, M.D.
|
| |
2/14/2020(6)
|
| |
25,930
|
| |
12,965
|
| |
9.51
|
| | |
| |
3/8/2021(7)
|
| |
15,000
|
| |
—
|
| | | | ||||
| |
6/9/2022(7)—
|
| |
15,000
|
| |
—
|
| | | |||||
|
Karen Wilson
|
| |
4/1/2020(6)
|
| |
25,930
|
| |
12,965
|
| |
9.51
|
| | |
| |
3/8/2021(7)
|
| |
15,000
|
| |
—
|
| | | | ||||
| |
6/9/2022(7)
|
| |
—
|
| |
15,000
|
| | | | ||||
|
(1)
|
Except as otherwise noted, all grants with a vesting commencement date in June 2020 and thereafter vest as to 1/48th of the
shares subject to the award on each monthly anniversary of the vesting commencement date, subject to the executive officer’s continued service to Angion through each vesting date.
|
|
(2)
|
The stock option award vests as to 25% of the shares on the vesting commencement date and thereafter 10% of the shares vest on
each quarterly anniversary, subject to Dr. Venkatesan’s continued service to Angion through such vesting date; provided that an additional 25% of the shares can vest if certain financing goals are achieved. This award is fully vested.
|
|
(3)
|
The stock option award vests as to 25% of the shares on the first anniversary of the vesting commencement date and vest as to
the remaining 75% of the shares in 24 substantially equal monthly installments thereafter, such that all awards will be vested on the anniversary of the vesting commencement date, subject to the executive officer’s continued service to
Angion through such vesting date.
|
|
(4)
|
The restricted stock units shall vest as to 25% of the shares on the first anniversary of the vesting commencement date and
vest as to the remaining 75% of the shares in 24 substantially equal monthly installments thereafter, such that all awards will be vested on the third anniversary of the vesting commencement date. In January 2022, the vesting schedule
for this grant was modified to vest annually on January 13, 2023, and then the vesting schedule was subsequently modified in December 2022 so that vesting shall occur upon certain triggering events in an amount equal to what she would
have other vested on the original monthly schedule, including if Ms. Rhodes is involuntary terminated, Ms. Rhodes resigned her employment with Angion, or if the current merger transaction announced by Angion on January 17, 2023 is
abandoned.
|
|
(5)
|
Dr. Venkatesan and Ms. Rhodes each received two stock option awards in March of 2022. The first award granted Dr. Venkatesan
of 600,000 shares and Ms. Rhodes of 160,000 shares, all vest at a rate of 1/48th of the shares subject to the award each month following the vesting commencement date. The second award granted Dr. Venkatesan of 160,000 shares and Ms.
Rhodes of 100,000 shares, all vest at a rate of 50% on July 31, 2022 and December 31, 2022. Both awards are subject to subject to the Named Executive Officer’s continued service to Angion through each vesting date.
|
|
(6)
|
Mr. Ganzi, Dr. Nissenson and Dr. Omenn each received a new director stock option award in February of 2020. Such awards
granted each 25,000 options, vesting annually over three years. Ms. Wilson received a new director stock option award in April of 2020 of 25,000 options, vesting annual over three years.
|
|
(7)
|
Mr. Ganzi, Dr. Nissenson, Dr. Omenn and Ms. Wilson each received annual director stock option awards of 15,000 options in
March of 2021 and June of 2022. Such grants vest annually over a one-year period.
|
Angion Restricted Stock Units
As of December 31, 2022, one of Angion’s named executive officers,
Jennifer R. Rhodes, owned a restricted stock unit to acquire 15,802 shares that shall vest as to 25% of the shares on the first anniversary of the vesting commencement date (February 14, 2020) and vest as to the remaining 75% of the shares in
24 substantially equal monthly installments thereafter, such that all awards will be vested on the third anniversary of the vesting commencement date. In January 2022, the vesting schedule for this grant was modified to vest annually on
January 13, 2023, and then the vesting schedule was subsequently modified in December 2022 so that vesting shall occur upon certain triggering events in an amount equal to what she would have other vested on the original monthly schedule,
including if Ms. Rhodes is involuntary terminated, Ms. Rhodes resigned her employment with Angion, or if the Merger is abandoned.
Indemnification and Insurance
For a discussion of the indemnification and insurance provisions
related to the Angion directors and officers under the Merger Agreement, please see the section titled, see the section titled “The Merger Agreement—Other Agreements—Indemnification and Insurance.”
123
In considering the recommendation of the Elicio Board with respect
to approving the Merger, Elicio stockholders should be aware that certain members of the Elicio Board and executive officers of Elicio have interests in the Merger that may be different from, or in addition to, interests they have as Elicio
stockholders. All of Elicio’s executive officers and directors have options, subject to vesting, to purchase shares of Elicio capital stock that will be converted into and become options to purchase shares of Angion common stock. Certain of
Elicio’s directors and executive officers are expected to become directors and executive officers of the combined organization upon the Closing and all of Elicio’s directors and executive officers are entitled to certain indemnification and
liability insurance coverage pursuant to the terms of the Merger Agreement.
Ownership Interests
Certain of Elicio’s directors and executive officers currently
hold shares of Elicio capital stock. The table below sets forth the anticipated ownership of Elicio capital stock by Elicio’s directors and executive officers immediately prior to the Closing based on their ownership of Elicio’s capital stock
as of April 1, 2023.
|
Directors and Executive Officers
|
| |
Number of
Shares of
Elicio Capital
Stock Held
Immediately
Prior to Closing
|
|
Julian Adams, Ph.D.
|
| |
—
|
|
Carol Ashe
|
| |
—
|
|
Yekaterina (Katie) Chudnovsky(1)
|
| |
38,819,875
|
|
Robert Connelly
|
| |
2,595,072
|
|
Daniel Geffken
|
| |
—
|
|
Christopher Haqq, M.D., Ph.D(2)
|
| |
2,565,565
|
|
Annette Matthies, Ph.D.
|
| |
—
|
|
Daphne Karydas
|
| |
—
|
|
Robert Ruffolo, Jr., Ph.D.
|
| |
—
|
|
Assaf Segal
|
| |
—
|
|
(1)
|
Consists of 38,819,875 shares of Elicio common stock held by GKCC, LLC issuable upon the conversion of 38,819,875 shares of
Elicio Series C preferred stock. Yekaterina (Katie) Chudnovsky is the sole member and manager of GKCC, LLC and may be deemed to beneficially own the shares held by GKCC, LLC.
|
|
(2)
|
Consists of: (i) 300,000 shares of Elicio common stock, of which 300,000 shares are subject to forfeiture pursuant to an early
exercise of a stock option prior to vesting and (ii) 2,265,565 shares of Elicio common stock underlying restricted stock units that will vest immediately prior to the Closing.
|
Certain Elicio Stockholders affiliated with Elicio’s directors
also currently hold shares of Elicio capital stock. The table below sets forth the anticipated ownership of Elicio capital stock by affiliates of Elicio’s directors immediately prior to the Closing based on their ownership of Elicio capital
stock as of April 1, 2023.
|
Stockholder Name
|
| |
Number of
Shares of
Elicio Capital
Stock Held
Immediately
Prior to Closing
|
|
GKCC, LLC(1)
|
| |
38,819,875
|
|
Clal Biotechnology Industries, Ltd.(2)
|
| |
34,497,911
|
|
(1)
|
See Note 1 to the previous table.
|
|
(2)
|
Consists of (i) 7,314,219 shares of Elicio common stock issuable upon the conversion of 5,000,000 shares of Elicio Series A
preferred stock, (ii) 16,675,693 shares of Elicio common stock issuable upon the conversion of 11,399,504 shares of Elicio Series B preferred stock, (iii) 10,507,999 shares of Elicio common stock issuable upon the conversion of
10,507,999 shares of Elicio Series C preferred stock, in each case, held by Clal Biotechnology Industries, Ltd (CBI). Assaf Segal is the Chief Executive Officer of CBI and also a member of the Elicio Board of Directors.
|
124
Treatment of Elicio Options
Under the Merger Agreement, at the Effective Time, each Elicio
Option outstanding and unexercised as of immediately prior to the Effective Time, whether or not vested, shall be converted into and become an option to purchase that number of shares of Angion common stock equal to the product obtained by
multiplying (i) the number of shares of Elicio common stock that were subject to such Elicio Option immediately prior to the Effective Time by (ii) the Exchange Ratio, and rounding the resulting number down to the nearest whole number of shares
of Angion common stock.
The following table presents certain information concerning the
outstanding Elicio Options held by Elicio’s directors and current executive officers, as of April 1, 2023:
|
Optionholder Name
|
| |
Grant Date
|
| |
Expiration
Date
|
| |
Exercise
Price
|
| |
Number of
Shares of
Elicio
Common
Stock
Underlying
Option as
of April 1,
2023
|
| |
Number of
Shares of
Elicio
Common
Stock
Underlying
Option Vested as
of April 1,
2023
|
|
Julian Adams
|
| |
1/20/2017
|
| |
1/20/2027
|
| |
$0.08
|
| |
250,000
|
| |
250,000
|
| |
3/20/2018
|
| |
3/20/2028
|
| |
$0.08
|
| |
120,000
|
| |
120,000
|
||
| |
11/15/2018
|
| |
11/15/2028
|
| |
$0.18
|
| |
401,484
|
| |
401,484
|
||
| |
9/2/2020
|
| |
9/2/2030
|
| |
$0.17
|
| |
100,000
|
| |
64,582
|
||
| |
3/31/2022
|
| |
3/31/2032
|
| |
$0.25
|
| |
75,000
|
| |
—
|
||
| |
12/6/2022
|
| |
12/6/2032
|
| |
$0.07
|
| |
1,888,773
|
| |
—
|
||
|
Carol Ashe
|
| |
9/2/2020
|
| |
9/2/2030
|
| |
$0.17
|
| |
200,000
|
| |
129,165
|
| |
3/31/2022
|
| |
3/31/2032
|
| |
$0.25
|
| |
75,000
|
| |
—
|
||
| |
12/6/2022
|
| |
12/6/2032
|
| |
$0.07
|
| |
548,781
|
| |
—
|
||
|
Yekaterina (Katie) Chudnovsky
|
| |
12/6/2022
|
| |
12/6/2032
|
| |
$0.07
|
| |
250,000
|
| |
—
|
|
Robert Connelly
|
| |
9/8/2020
|
| |
9/8/2030
|
| |
$0.17
|
| |
1,500,000
|
| |
1,500,000
|
| |
11/28/2022
|
| |
11/28/2032
|
| |
$0.07
|
| |
8,171,995
|
| |
907,999
|
||
|
Daniel Geffken
|
| |
2/25/2015
|
| |
2/25/2025
|
| |
$0.08
|
| |
5,000
|
| |
5,000
|
| |
10/2/2017
|
| |
10/2/2027
|
| |
$0.08
|
| |
40,000
|
| |
40,000
|
||
| |
3/20/2018
|
| |
3/20/2028
|
| |
$0.00
|
| |
45,000
|
| |
45,000
|
||
| |
11/15/2018
|
| |
11/15/2028
|
| |
$0.08
|
| |
199,306
|
| |
199,306
|
||
| |
9/2/2020
|
| |
9/2/2030
|
| |
$0.17
|
| |
100,000
|
| |
64,582
|
||
| |
3/31/2022
|
| |
3/31/2032
|
| |
$0.25
|
| |
75,000
|
| |
—
|
||
| |
12/6/2022
|
| |
12/6/2032
|
| |
$0.07
|
| |
926,554
|
| |
—
|
||
|
Christopher Haqq, M.D., Ph.D.
|
| |
3/31/2022
|
| |
3/31/2032
|
| |
$0.25
|
| |
200,000
|
| |
—
|
| |
11/28/2022
|
| |
11/28/2032
|
| |
$0.07
|
| |
5,518,873
|
| |
613,208
|
||
|
Annette Matthies, Ph.D.
|
| |
2/1/2021
|
| |
2/1/2031
|
| |
$0.23
|
| |
1,416,166
|
| |
767,090
|
| |
3/31/2022
|
| |
3/31/2032
|
| |
$0.25
|
| |
100,000
|
| |
—
|
||
| |
11/28/2022
|
| |
11/28/2032
|
| |
$0.07
|
| |
3,025,613
|
| |
336,179
|
||
|
Daphne Karydas
|
| |
9/2/2020
|
| |
9/2/2030
|
| |
$0.17
|
| |
200,000
|
| |
129,165
|
| |
3/31/2022
|
| |
3/31/2032
|
| |
$0.25
|
| |
75,000
|
| |
—
|
||
| |
12/6/2022
|
| |
12/6/2032
|
| |
$0.07
|
| |
548,781
|
| |
—
|
||
|
Robert Ruffolo, Jr., Ph.D.
|
| |
2/20/2020
|
| |
2/20/2030
|
| |
$0.17
|
| |
40,000
|
| |
40,000
|
| |
9/2/2020
|
| |
9/2/2020
|
| |
$0.17
|
| |
200,000
|
| |
129,165
|
||
| |
3/31/2022
|
| |
3/31/2032
|
| |
$0.25
|
| |
75,000
|
| |
—
|
||
| |
12/6/2022
|
| |
12/6/2032
|
| |
$0.07
|
| |
628,604
|
| |
—
|
||
|
Assaf Segal
|
| |
12/6/2022
|
| |
12/6/2032
|
| |
$0.07
|
| |
250,000
|
| |
—
|
125
|
Optionholder Name
|
| |
Grant Date
|
| |
Expiration
Date
|
| |
Exercise
Price
|
| |
Number of
Shares of
Elicio
Common
Stock
Underlying
Option as
of April 1,
2023
|
| |
Number of
Shares of
Elicio
Common
Stock
Underlying
Option Vested as
of April 1,
2023
|
|
Peter DeMuth, Ph.D.
|
| |
2/25/2014
|
| |
2/25/2024
|
| |
$0.08
|
| |
18,900
|
| |
18,900
|
| |
12/18/2014
|
| |
12/18/2024
|
| |
$0.08
|
| |
21,100
|
| |
21,100
|
||
| |
12/10/2015
|
| |
12/10/2025
|
| |
$0.08
|
| |
20,000
|
| |
20,000
|
||
| |
11/4/2016
|
| |
11/4/2026
|
| |
$0.08
|
| |
20,000
|
| |
20,000
|
||
| |
10/2/2017
|
| |
10/2/2027
|
| |
$0.08
|
| |
80,000
|
| |
80,000
|
||
| |
12/27/2017
|
| |
12/27/2027
|
| |
$0.08
|
| |
10,000
|
| |
10,000
|
||
| |
3/20/2018
|
| |
3/20/2028
|
| |
$0.08
|
| |
45,000
|
| |
45,000
|
||
| |
10/12/2018
|
| |
10/12/2028
|
| |
$0.18
|
| |
136,802
|
| |
136,802
|
||
| |
3/24/2020
|
| |
3/24/2030
|
| |
$0.17
|
| |
450,000
|
| |
337,500
|
||
| |
2/26/2021
|
| |
2/26/2031
|
| |
$0.23
|
| |
50,000
|
| |
26,042
|
||
| |
3/31/2022
|
| |
3/31/2032
|
| |
$0.25
|
| |
800,000
|
| |
—
|
||
| |
11/28/2022
|
| |
11/28/2032
|
| |
$0.07
|
| |
3,356,151
|
| |
372,906
|
The foregoing discussion of the interests of the Elicio Directors
and Officers in the Merger does not reflect the effect of the Reverse Stock Split and is not adjusted to reflect the effect of the Exchange Ratio.
Management Following the Merger
As described elsewhere in this proxy
statement/prospectus/information statement, including in the section captioned “Management Following the Merger,” certain of Elicio’s directors and executive officers are expected to become the directors and executive officers of Angion upon
the Closing.
Indemnification and Insurance
Under the Merger Agreement, from the Effective Time through the
sixth anniversary of the date on which the Effective Time occurs, Angion and Elicio, as the surviving corporation in the Merger, shall indemnify and hold harmless each person who is or has served as a director or officer of Elicio against all
claims, losses, liabilities, damages, judgments, fines and reasonable fees, costs and expenses, including attorneys’ fees and disbursements, incurred in connection with any claim, action, suit, proceeding or investigation, whether civil,
criminal, administrative or investigative, arising out of or pertaining to the fact that such person is or was a director, officer, fiduciary or agent of Elicio, to the fullest extent permitted under the DGCL for directors or officers of
Delaware corporations. In addition, each such director and officer, or former director and officer, is entitled to advancement of expenses incurred in the defense of any such claim, action, suit, proceeding or investigation.
Under the Merger Agreement, the provisions of Angion’s amended and
restated certificate of incorporation and amended and restated bylaws with respect to indemnification, advancement of expenses and exculpation of present and former directors and officers of Angion shall not be amended, modified or repealed for
a period of six years from the Effective Time in a manner that would adversely affect the rights thereunder of individuals who, at or prior to the Effective Time, were officers or directors of Angion. The certificate of incorporation and bylaws
of Elicio, as the surviving corporation in the Merger, shall contain provisions no less favorable with respect to indemnification, advancement of expenses and exculpation of former and present directors and officers that are presently set forth
in the amended and restated certificate of incorporation and amended and restated bylaws of Angion.
The Merger Agreement also provides that Angion shall maintain
directors’ and officers’ liability insurance policies commencing at the Closing, on commercially available terms and conditions with coverage limits customary for U.S. public companies similar situated to Angion.
126
Under the Merger Agreement, Merger Sub, a wholly owned subsidiary
of Angion formed in connection with the Merger, will merge with and into Elicio, with Elicio surviving as a wholly owned subsidiary of Angion. Substantially concurrently with the completion of the Merger, Angion will be renamed “Elicio
Therapeutics, Inc.” and expects to trade on The Nasdaq Global Market under the symbol “ELTX.”
Immediately following the Merger, the executive management team of
the combined company is expected to be comprised of the following individuals with such additional officers as may be added by Elicio or the combined company:
|
Name
|
| |
Position with the Combined Company
|
| |
Current Position at Elicio
|
|
Robert Connelly
|
| |
Chief Executive Officer, President
and Director
|
| |
Chief Executive Officer
|
|
|
| |
|
| |
|
|
Daniel Geffken
|
| |
Interim Chief Financial Officer
|
| |
Interim Chief Financial Officer
|
|
|
| |
|
| |
|
|
Christopher Haqq, M.D., Ph.D.
|
| |
Executive Vice President, Head of Research and Development and Chief Medical
Officer
|
| |
Executive Vice President, Head of Research and Development and Chief Medical
Officer
|
|
|
| |
|
| |
|
|
Annette Matthies, Ph.D.
|
| |
Chief Business Officer
|
| |
Chief Business Officer
|
|
|
| |
|
| |
|
|
Peter DeMuth, Ph.D.
|
| |
Chief Scientific Officer
|
| |
Chief Scientific Officer
|
At the Effective Time, the combined company is expected to
initially have a nine-member board of directors, comprised of (a) Mr. Robert Connelly, Julian Adams, Ph.D., Carol Ashe, Yekaterina (Katie) Chudnovsky, Daphne Karydas, and Assaf Segal, each as an Elicio designee and (b) Mr. Jay Venkatesan, M.D.,
MBA, Karen J. Wilson, and Allen R. Nissenson, M.D., each as an Angion designee, until their respective successors are duly elected or appointed and qualified or their earlier death, resignation or removal.
The aforementioned board of directors will have an audit
committee, a compensation committee and a nominating and corporate governance committee, in accordance with the Nasdaq rules. All of Angion’s current directors, other than Dr. Venkatesan, Karen J. Wilson and Allen R. Nissenson, M.D., are
expected to resign from their positions as directors of Angion, effective as of the Effective Time.
For a discussion of merger
consideration and the Exchange Ratio, please see the section titled “The Merger Agreement—Merger Consideration and Exchange Ratio” beginning on page 135.
Treatment of Angion Stock Options
All outstanding and unexercised options to purchase shares of
Angion common stock will remain effective and outstanding. As of December 31, 2022, there were outstanding options to purchase up to an aggregate of 3,306,092 shares of Angion common stock. As of December 31, 2022, Angion’s current executive
officers and directors hold outstanding options to purchase an aggregate of 2,690,673 shares of Angion common stock.
Under the terms of the Merger Agreement, each option to purchase
shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, whether or not vested, will be converted into and become an option to purchase shares of Angion common stock. Angion will assume the
Elicio Plans and all such Elicio stock options in accordance with the terms of the Elicio Plans and the terms of the stock option agreement by which such option is evidenced.
127
Accordingly, from and after the Effective Time: (i) each
outstanding Elicio stock option assumed by Angion may be exercised solely for shares of Angion common stock; (ii) the number of shares of Angion common stock subject to each outstanding Elicio stock option assumed by Angion will be determined
by multiplying (A) the number of shares of Elicio common stock that were subject to such Elicio stock option, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio, and rounding the resulting number down to the nearest
whole number of shares of Angion common stock; (iii) the per share exercise price for the Angion common stock issuable upon exercise of each Elicio stock option assumed by Angion will be determined by dividing (A) the per share exercise price
of Angion common stock subject to such Elicio stock option, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio and rounding the resulting exercise price up to the nearest whole cent; and (iv) any restriction on the
exercise of any Elicio stock option assumed by Angion will continue in full force and effect and the term, exercisability, vesting schedule, accelerated vesting provisions, and any other provisions of such Elicio stock option will otherwise
remain unchanged; provided, however, that the Angion Board or a committee thereof will succeed to the authority and responsibility of the Elicio Board or any committee thereof with respect to each Elicio stock option assumed by Angion.
Under the terms of the Merger Agreement, each warrant to purchase
shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, will be converted into and become a warrant to purchase shares of Angion common stock and Angion will assume each Elicio warrant in
accordance with its terms. The number of shares of Angion common stock and the exercise price of each warrant will be appropriately adjusted to give effect to the Exchange Ratio.
Except as otherwise expressly provided in the Merger Agreement,
all costs and expenses incurred in connection with the Merger Agreement and the transactions contemplated therein, including the Merger, will be paid by the party incurring such expense, whether or not the Merger is consummated, except Angion
will pay (i) all fees paid to the SEC in connection with filing this proxy statement/prospectus/information statement, and any amendments and supplements hereto, with the SEC, (ii) all fees and expenses in connection with the filing, printing,
mailing and distribution of this proxy statement/prospectus/information statement, and any amendments and supplements hereto, and (iii) half of the Nasdaq fees associated with the Nasdaq listing application.
The Merger will be completed as promptly as practicable (but no
later than the second business day) after all of the conditions to the closing of the Merger are satisfied or waived, including the approval of the stockholders of Angion and Elicio, unless earlier terminated in accordance with the terms of the
Merger Agreement. For more information on termination rights, see the section titled “The Merger Agreement—Termination and Termination Fees” on page 151. The Merger is anticipated to
occur after the Angion special meeting, which is further described on page 93. Angion and Elicio cannot predict the exact timing of the closing of the Merger because it is subject to various conditions.
In the United States, Angion must comply with applicable federal
and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of Angion common stock to Elicio’s stockholders in connection with the transactions contemplated by the Merger Agreement and the filing
of this proxy statement/prospectus/information statement with the SEC. Angion does not intend to seek any regulatory approval from antitrust authorities to consummate the transactions.
The following discussion summarizes material U.S. federal income
tax consequences of the Merger that are generally expected to be applicable to Elicio stockholders who are U.S. holders (as defined below), assuming the Merger is consummated as contemplated herein. This summary is based on current law,
including the provisions of the Code, Treasury Regulations promulgated thereunder, judicial authority, and administrative rulings and practice, each as in effect as of the date of this proxy statement/prospectus/information statement and all of
which are subject to change, possibly with retroactive effect.
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This summary is not a complete description of all tax
consequences of the Merger and does not address U.S. federal income tax consequences that may be relevant to particular Elicio stockholders in light of their personal circumstances or to Elicio stockholders who are subject to special treatment
under U.S. federal income tax laws, such as Elicio stockholders who: do not hold their Elicio capital stock as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment); are banks, insurance
companies, tax-exempt entities, mutual funds, financial institutions, real estate investment trusts, regulated investment companies, government entities or broker-dealers; hold their Elicio capital stock as “qualified small business stock”
under Section 1202 of the Code or as “Section 1244 stock” under Section 1244 of the Code; hold their Elicio capital stock as part of a hedging, “straddle,” conversion or other integrated transaction or are treated as having sold their Elicio
stock pursuant to the constructive sale provisions of the Code; are not U.S. holders; acquired their Elicio capital stock pursuant to the exercise of compensatory options, or in other compensatory transactions; acquired their Elicio capital
stock pursuant to the exercise of warrants or conversion rights under convertible instruments; are subject to special tax accounting rules under Section 451(b) of the Code; hold their Elicio capital stock through individual retirement or other
tax-deferred accounts; acquired their Elicio capital stock in a transaction subject to the gain rollover provisions of Section 1045 of the Code; have a functional currency other than the U.S. dollar; or are partnerships or entities or
arrangements classified as partnerships or disregarded entities for U.S. federal income tax purposes, S corporations, or other pass-through entities (including hybrid entities) and investors therein.
In addition, this summary does not address (i) the tax
consequences of the Merger under U.S. federal non-income tax law (including estate, gift, or other non-income taxes), (ii) the tax consequences of the Merger under state, local or non-U.S. tax laws, (iii) the impact of the alternative minimum
tax provisions of the Code (including the 15% minimum tax applicable to the adjusted financial statement income of certain corporations) or the Medicare contribution tax on net investment income, (iv) the tax consequences of transactions
effectuated before, subsequent to or concurrently with the Merger (whether or not any such transactions are consummated in connection with the Merger), including, without limitation, any transaction in which shares of Elicio capital stock are
acquired, (v) the tax consequences to holders of Elicio stock options, Elicio warrants or similar rights to acquire Elicio capital stock, or (vi) the tax consequences of the Merger to Elicio stockholders who exercise appraisal or dissenters’
rights.
If a partnership or other entity or arrangement taxable as a
partnership for U.S. federal income tax purposes holds Elicio capital stock, the tax treatment of a partner in such partnership will generally depend on the status of the partner and the activities of the partnership. Such partner should
consult its tax advisors as to the tax consequences of the Merger.
This summary is limited to Elicio stockholders who are U.S.
holders. A U.S. holder is a beneficial owner of Elicio capital stock that is for U.S. federal income tax purposes:
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an individual who is a citizen or resident of the United States;
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a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the United States, any
state thereof, or the District of Columbia;
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an estate the income of which is subject to U.S. federal income tax regardless of its source; or
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a trust with respect to which a court within the United States is able to exercise primary supervision over its
administration and one or more U.S. persons have the authority to control all of its substantial decisions, or an electing trust that was in existence on August 19, 1996 and was treated as a domestic trust on that date.
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IN VIEW OF THE FOREGOING AND BECAUSE THE
FOLLOWING DISCUSSION IS INTENDED AS A GENERAL SUMMARY ONLY, EACH ELICIO STOCKHOLDER SHOULD CONSULT SUCH STOCKHOLDER’S OWN TAX ADVISOR REGARDING THE TAX CONSEQUENCES, INCLUDING THE APPLICABLE U.S. FEDERAL, STATE, LOCAL AND NON-U.S. TAX
CONSEQUENCES, AND ANY TAX REPORTING REQUIREMENTS OF THE MERGER AND RELATED TRANSACTIONS IN LIGHT OF SUCH STOCKHOLDER’S OWN TAX SITUATION.
General
Each of Angion and Elicio intends the Merger to qualify as a
“reorganization” within the meaning of Section 368(a) of the Code. In connection with the filing of the Registration Statement on Form S-4 of which this proxy statement/prospectus/information statement forms a part, Cooley will deliver to
Angion and Mintz will deliver
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to Elicio opinions that the material U.S. federal income tax consequences of the
Merger to Elicio stockholders who are U.S. holders U.S. holders are as described below under the heading “—Treatment of U.S. Holders in the Merger.” These opinions are based on facts and representations
contained in representation letters provided by Angion and Elicio and on customary factual assumptions, and further assume that the Merger is completed in the manner set forth in the Merger Agreement and the Registration Statement on Form S-4
of which this proxy statement/prospectus/information statement forms a part. In addition, the tax opinions will be based on the law in effect on the date of the opinions and will assume that there will be no change in applicable law between
such date and the time of the Merger. If any assumption or representation is or becomes inaccurate, the U.S. federal income tax consequences of the Merger could be adversely affected. Neither Angion nor Elicio intends to obtain a ruling from
the IRS with respect to the tax consequences of the Merger. Further, the Merger is not conditioned upon obtaining an opinion from counsel that the Merger will qualify as a reorganization. Accordingly, no assurance can be given that the IRS will
not challenge the Merger’s qualification as a “reorganization” within the meaning of Section 368(a) of the Code or that a court would not sustain such a challenge, and Elicio stockholders should consult their own tax advisors as to the specific
tax consequences to them of the Merger, including applicable tax reporting requirements.
Treatment of U.S. Holders in the Merger
Subject to the qualifications and assumptions described in this
proxy statement/prospectus/information statement, the Merger will qualify as a reorganization under Section 368(a) of the Code. If the Merger does not qualify as a reorganization within the meaning of Section 368(a) of the Code, then each U.S.
holder would be treated as exchanging its Elicio capital stock in a fully taxable transaction in exchange for Angion common stock and any cash received in lieu of a fractional share of Angion common stock. U.S. holders generally would recognize
capital gain or loss in such exchange equal to the difference between (i) the sum of the fair market value of the Angion common stock received in the Merger and any cash received in lieu of a fractional share of Angion common stock and
(ii) such holder’s tax basis in the Elicio capital stock surrendered in the Merger. The aggregate tax basis of a U.S. holder in the Angion common stock received in the Merger would equal the fair market value at the Effective Time of the U.S.
holder’s Elicio capital stock exchanged in the Merger, and the holding period of Angion common stock received in the Merger would begin on the day after the Effective Time of the Merger.
For purposes of the above discussion of the bases and holding
periods for shares of Elicio capital stock acquired by U.S. holders at different times for different prices, such U.S. holders must calculate their gains and losses and holding periods separately for each identifiable block of such stock
exchanged in the Merger.
U.S. holders are urged to consult their tax
advisors regarding the U.S. federal income tax consequences of the Merger in light of their personal circumstances and the consequences to them under state, local and non-U.S. tax laws and other federal tax laws.
Information Reporting and Backup Withholding
Each U.S. holder who receives shares of Angion common stock in the
Merger is required to retain permanent records pertaining to the Merger and make such records available to any authorized IRS officers and employees. Such records should specifically include information regarding the amount, basis, and fair
market value of all transferred property, and relevant facts regarding any liabilities assumed or extinguished as part of such reorganization. U.S. holders who owned immediately before the Merger at least one percent (by vote or value) of the
total outstanding stock of Elicio are required to attach a statement to their tax returns for the year in which the Merger is consummated that contains the information listed in Treasury Regulation Section 1.368-3(b). Such statement must
include the U.S. holder’s tax basis in such U.S. holder’s Elicio capital stock surrendered in the Merger, the fair market value of such Elicio capital stock, the date of the Merger and the name and employer identification number of each of
Elicio and Angion. U.S. holders are urged to consult with their tax advisors to comply with these rules.
A U.S. holder may be subject to information reporting and backup
withholding for U.S. federal income tax purposes on cash paid in lieu of fractional shares in connection with the Merger. Backup withholding will not apply, however, to a U.S. holder who (i) furnishes a correct taxpayer identification number
and certifies the holder is not subject to backup withholding on IRS Form W-9 or a substantially similar form, or (ii) certifies the holder is otherwise exempt from backup withholding. If a U.S. holder does not provide a correct taxpayer
identification number on IRS Form W-9 or other proper certification, the U.S. holder may be subject to penalties imposed by the IRS. Any amounts withheld under the backup withholding rules may be refunded or allowed as a credit against the
federal income tax liability of a U.S. holder, if any, provided the required information is timely furnished to the IRS.
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U.S. holders should consult their tax advisors regarding their qualification for
an exemption from backup withholding, the procedures for obtaining such an exemption, and in the event backup withholding is applied, to determine if any tax credit, tax refund or other tax benefit may be obtained.
This summary does not take into account your
particular circumstances and does not address consequences that may be particular to you. Therefore, you should consult your tax advisor regarding the particular consequences of the Merger to you.
Angion common stock currently is listed on The Nasdaq Global
Select Market under the symbol “ANGN.” Angion has agreed to use commercially reasonable efforts (i) to maintain its existing listing on Nasdaq until the Effective Time and obtain approval of the listing of the combined company on Nasdaq,
(ii) to the extent required by the rules and regulations of Nasdaq, to prepare and submit to Nasdaq a notification form for the listing of the shares of Angion common stock to be issued in connection with the Contemplated Transactions, and to
cause such shares to be approved for listing (subject to official notice of issuance), (iii) to effect the Reverse Stock Split and (iv) to the extent required by Nasdaq Marketplace Rule 5110, to file an initial Nasdaq Listing Application for
the Angion common stock on Nasdaq and to cause such listing application to be conditionally approved prior to the Effective Time.
In addition, under the Merger Agreement, each of Elicio’s and
Angion’s obligation to complete the Merger is subject to the satisfaction or waiver by each of the parties, at or prior to the Merger, of various conditions, including that the shares of Angion common stock to be issued in the Merger have been
approved for listing on Nasdaq as of the closing of the Merger. The terms of the Merger Agreement permit that this condition may be waived by agreement among Elicio, Angion and Merger Sub, without recirculation or resolicitation of this proxy
statement/prospectus/information statement.
If the Nasdaq Listing Application is accepted, Angion anticipates
that the common stock of the combined company will be listed on the Nasdaq Global Market following the closing of the Merger under the trading symbol “ELTX.”
The Merger will be treated by Angion as a reverse recapitalization
under GAAP. For accounting purposes, Elicio is considered to be the accounting acquirer in this transaction.
Angion
Under the DGCL, Angion stockholders are not entitled to appraisal
rights in connection with the Merger.
Elicio
Elicio stockholders are entitled to appraisal rights in connection
with the Merger under Section 262 of the DGCL.
The discussion below is not a complete summary regarding Elicio
stockholders’ appraisal rights under Delaware law and is qualified in its entirety by reference to the text of the relevant provisions of Delaware law, which are attached as Annex C. Stockholders
intending to exercise appraisal rights should carefully review Annex C. Failure to follow precisely any of the statutory procedures set forth in Annex C may
result in a termination or waiver of these rights. This summary does not constitute legal or other advice, nor does it constitute a recommendation that Elicio stockholders exercise their appraisal rights under Delaware law.
Under Section 262, where a merger is adopted by stockholders by
written consent in lieu of a meeting of stockholders pursuant to Section 228 of the DGCL, either the constituent corporation before the effective date of such merger or the surviving corporation, within 10 days after the effective date of such
merger, must notify each stockholder of the constituent corporation entitled to appraisal rights of the approval of such merger, the effective date of such merger and that appraisal rights are available.
If the Merger is completed, within 10 days after the effective
date of the Merger, Elicio will notify its stockholders that the Merger has been approved, the effective date of the Merger and that appraisal rights are
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available to any stockholder who has not approved the Merger. Holders of shares of
Elicio capital stock who desire to exercise their appraisal rights must deliver a written demand for appraisal to Elicio within 20 days after the date of the giving of that notice, and that stockholder must not have delivered a written consent
approving the Merger. A demand for appraisal must reasonably inform Elicio of the identity of the stockholder and that such stockholder intends thereby to demand appraisal of the shares of Elicio capital stock held by such stockholder. Failure
to deliver a written consent approving the Merger will not in and of itself constitute a written demand for appraisal satisfying the requirements of Section 262. All demands for appraisal should be addressed to Elicio, 2533 S Coast Hwy 101,
Suite #210, Cardiff, CA 92007, Attention: Michael Mueller, Email: mmueller@Elicio.com, and should be executed by, or on behalf of, the record holder of shares of Elicio capital stock. ALL DEMANDS MUST BE RECEIVED BY ELICIO WITHIN 20 DAYS AFTER
THE DATE ELICIO GIVES A NOTICE TO ITS STOCKHOLDERS NOTIFYING THEM THAT THE MERGER HAS BEEN APPROVED, THE EFFECTIVE DATE OF THE MERGER AND THAT APPRAISAL RIGHTS ARE AVAILABLE TO ANY STOCKHOLDER WHO HAS NOT APPROVED THE MERGER.
If you fail to deliver a written demand for appraisal within the
time period specified above, you will be entitled to receive the merger consideration for your shares of Elicio capital stock as provided for in the Merger Agreement, but you will have no appraisal rights with respect to your shares of Elicio
capital stock. To be effective, a demand for appraisal by a holder of shares of Elicio capital stock must be made by, or in the name of, the registered stockholder, fully and correctly, as the stockholder’s name appears on the stockholder’s
stock certificate(s). Beneficial owners who do not also hold the shares of record may not directly make appraisal demands to Elicio. The beneficial owner must, in these cases, have the registered owner, such as a broker, bank or other
custodian, submit the required demand in respect of those shares. If shares are owned of record in a fiduciary capacity, such as by a trustee, guardian or custodian, execution of a demand for appraisal should be made by or for the fiduciary;
and if the shares are owned of record by more than one person, as in a joint tenancy or tenancy in common, the demand should be executed by or for all joint owners. An authorized agent, including an authorized agent for two or more joint
owners, may execute the demand for appraisal for a stockholder of record; however, the agent must identify the record owner or owners and expressly disclose the fact that, in executing the demand, he or she is acting as agent for the record
owner. A record owner, such as a broker, who holds shares as a custodian for others, may exercise the record owner’s right of appraisal with respect to the shares held for one or more beneficial owners, while not exercising this right for other
beneficial owners. In that case, the written demand should state the number of shares as to which appraisal is sought. Where no number of shares is expressly mentioned, the demand will be presumed to cover all shares held in the name of the
record owner. In addition, the stockholder must continuously hold the shares of record from the date of making the demand through the Effective Time.
If you hold your shares of Elicio capital stock in a brokerage
account or in other custodian form and you wish to exercise appraisal rights, you should consult with your bank, broker or other custodian to determine the appropriate procedures for the making of a demand for appraisal by the custodian.
At any time within 60 days after the Effective Time, any
stockholder who has demanded an appraisal, but has neither commenced an appraisal proceeding or joined an appraisal proceeding as a named party, has the right to withdraw such stockholder’s demand and accept the terms of the Merger by
delivering a written withdrawal to Elicio. If, following a demand for appraisal, you have withdrawn your demand for appraisal in accordance with Section 262, you will have the right to receive the merger consideration for your shares of Elicio
capital stock.
Within 120 days after the effective date of the Merger, any
stockholder who has delivered a demand for appraisal in accordance with Section 262 will, upon written request to the surviving corporation, be entitled to receive a written statement setting forth the aggregate number of shares not voted in
favor of the Merger Agreement and with respect to which demands for appraisal rights have been received and the aggregate number of holders of these shares. This written statement will be given to the requesting stockholder within 10 days after
the stockholder’s written request is received by the surviving corporation or within 10 days after expiration of the period for delivery of demands for appraisal, whichever is later. Within 120 days after the effective date of the merger,
either the surviving corporation or any stockholder who has delivered a demand for appraisal in accordance with Section 262 may file a petition in the Delaware Court of Chancery demanding a determination of the fair value of the shares held by
all such stockholders. Upon the filing of the petition by a stockholder, service of a copy of the petition must be made upon the surviving corporation. The surviving corporation has no obligation to file a petition in the Delaware Court of
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Chancery in the event there are dissenting stockholders, and Elicio, which is
expected to be the surviving corporation, has no present intent to file a petition in the Delaware Court of Chancery. Accordingly, the failure of a stockholder to file a petition within the period specified could nullify the stockholder’s
previously written demand for appraisal.
If a petition for appraisal is duly filed by a stockholder and a
copy of the petition is delivered to the surviving corporation, the surviving corporation will then be obligated, within 20 days after receiving service of a copy of the petition, to provide the Delaware Court of Chancery with a duly verified
list containing the names and addresses of all stockholders who have demanded an appraisal of their shares and with whom agreements as to the value of their shares have not been reached by the surviving corporation. After notice to dissenting
stockholders who demanded appraisal of their shares, the Delaware Court of Chancery is empowered to conduct a hearing upon the petition, and to determine those stockholders who have complied with Section 262 and who have become entitled to the
appraisal rights provided thereby. The Delaware Court of Chancery may require the stockholders who have demanded appraisal for their shares to submit their stock certificates to the Register in Chancery for notation thereon of the pendency of
the appraisal proceedings; and if any stockholder fails to comply with that direction, the Delaware Court of Chancery may dismiss the proceedings as to that stockholder.
After determination of the stockholders entitled to appraisal of
their shares, the Delaware Court of Chancery will appraise the “fair value” of the shares owned by those stockholders. This value will be exclusive of any element of value arising from the accomplishment or expectation of the Merger, but may
include a fair rate of interest, if any, upon the amount determined to be the fair value. When the value is determined, the Delaware Court of Chancery will direct the payment of the value, with interest thereon accrued during the pendency of
the proceeding, if the Delaware Court of Chancery so determines, to the stockholders entitled to receive the same, upon surrender by the holders of the certificates representing those shares. At any time before the entry of judgment in the
proceedings, the surviving corporation may pay to each stockholder entitled to appraisal an amount in cash, in which case interest shall accrue thereafter only upon the sum of (i) the difference, if any, between the amount so paid and the fair
value of the shares subject to appraisal as determined by the Delaware Court of Chancery and (ii) interest theretofore accrued, unless paid at that time.
In determining fair value, and, if applicable, a fair rate of
interest, the Delaware Court of Chancery is required to take into account all relevant factors. In Weinberger v. UOP, Inc., the Delaware Supreme Court discussed the factors that could be considered in
determining fair value in an appraisal proceeding, stating that “proof of value by any techniques or methods which are generally considered acceptable in the financial community and otherwise admissible in court” should be considered, and that
“fair price obviously requires consideration of all relevant factors involving the value of a company.”
Section 262 provides that fair value is to be “exclusive of any
element of value arising from the accomplishment or expectation of the merger.” In Cede & Co. v. Technicolor, Inc., the Delaware Supreme Court stated that this exclusion is a “narrow exclusion
[that] does not encompass known elements of value,” but which rather applies only to the speculative elements of value arising from such accomplishment or expectation. In Weinberger, the Delaware
Supreme Court construed Section 262 to mean that “elements of future value, including the nature of the enterprise, which are known or susceptible of proof as of the date of the merger and not the product of speculation, may be considered.”
You should be aware that the fair value of your shares as
determined under Section 262 could be more than, the same as, or less than the value that you are entitled to receive under the terms of the Merger Agreement.
Costs of the appraisal proceeding may be imposed upon the
surviving corporation and the stockholders participating in the appraisal proceeding by the Delaware Court of Chancery as the Court deems equitable in the circumstances. Upon the application of a stockholder, the Delaware Court of Chancery may
order all or a portion of the expenses incurred by any stockholder in connection with the appraisal proceeding, including, without limitation, reasonable attorneys’ fees and the fees and expenses of experts, to be charged pro rata against the
value of all shares entitled to appraisal. In the absence of such a determination of assessment, each party bears its own expenses. Any stockholder who had demanded appraisal rights will not, after the Effective Time, be entitled to vote shares
subject to that demand for any purpose or to receive payments of dividends or any other distribution with respect to those shares, other than with respect to payment as of a record date prior to the Effective Time; however, if no petition for
appraisal is filed within 120 days after the Effective Time, or if the stockholder delivers a written withdrawal of his or her demand for appraisal and an acceptance of the terms of the Merger within 60 days after the Effective Time, then the
right of that stockholder to appraisal will cease and that stockholder will be entitled to receive the merger
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consideration for shares of his or her Elicio capital stock pursuant to the Merger
Agreement. Any withdrawal of a demand for appraisal made more than 60 days after the Effective Time may only be made with the written approval of the surviving corporation. No appraisal proceeding in the Delaware Court of Chancery will be
dismissed as to any stockholder without the approval of the court.
Failure to follow the steps required by Section 262 for perfecting
appraisal rights may result in the loss of appraisal rights. In view of the complexity of Section 262, stockholders who may wish to dissent from the Merger and pursue appraisal rights should consult their legal advisors.
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The following is a summary of the material
terms of the Merger Agreement. A copy of the Merger Agreement is attached as Annex A to this proxy statement/prospectus/information statement and is incorporated by reference. The Merger Agreement has been attached to this proxy
statement/prospectus/information statement to provide you with information regarding its terms. It is not intended to provide any other factual information about Angion, Elicio or Merger Sub. The following description does not purport to be
complete and is qualified in its entirety by reference to the Merger Agreement. You should refer to the full text of the Merger Agreement for details of the Merger and the terms and conditions of the Merger Agreement.
The Merger Agreement contains representations and warranties that
Angion and Merger Sub, on the one hand, and Elicio, on the other hand, have made to one another as of specific dates. These representations and warranties have been made for the benefit of the other parties to the Merger Agreement and may be
intended not as statements of fact but rather as a way of allocating the risk to one of the parties if such statements made in the representations and warranties prove to be incorrect. In addition, the assertions made in the representations and
warranties are qualified by the information in confidential disclosure schedules exchanged by the parties in connection with the signing of the Merger Agreement. While Angion and Elicio do not believe that these disclosure schedules contain
information required to be publicly disclosed under the applicable securities laws, other than information that has already been so disclosed, the disclosure schedules contain information that modifies, qualifies and creates exceptions to the
representations and warranties set forth in the Merger Agreement. Accordingly, you should not rely on the representations and warranties as current characterizations of factual information about Angion, Elicio or Merger Sub, because they were
made as of specific dates, may be intended merely as a risk allocation mechanism between Angion and Merger Sub on the one hand, and Elicio on the other hand, and are modified by the disclosure schedules.
Under the Merger Agreement, Merger Sub, a wholly owned subsidiary
of Angion formed in connection with the Merger, will merge with and into Elicio, with Elicio surviving as a wholly owned subsidiary of Angion. Substantially concurrently with the completion of the Merger, Angion will be renamed “Elicio
Therapeutics, Inc.” and expects to trade on The Nasdaq Global Market under the symbol “ELTX.”
The Merger will be completed as promptly as practicable (but no
later than the second business day) after all of the conditions to the closing of the Merger (Closing; and the date on which Closing actually takes place, the Closing Date) are satisfied or waived, including the approval of the stockholders of
Angion, unless earlier terminated in accordance with the terms of the Merger Agreement. For more information on termination rights, see the section titled “The Merger Agreement—Termination and Termination Fees.”
The Merger is anticipated to occur after the Angion special meeting of stockholders, which is further described in the section titled “The Special Meeting of Angion’s Stockholders.” Angion and Elicio
cannot predict the exact timing of Closing because it is subject to various conditions.
Merger Consideration
At the Effective Time, each share of Elicio capital stock
outstanding immediately prior to the Effective Time and after giving effect to the Preferred Stock Conversion will be automatically converted solely into the right to receive a number of validly issued, fully paid and nonassessable shares of
Angion common stock equal to the Exchange Ratio (as defined below).
No fractional shares of Angion common stock will be issued in
connection with the Merger, and no certificates or scrip for any such fractional shares will be issued. Any holder of Elicio capital stock who would otherwise be entitled to receive a fraction of a share of Angion common stock (after
aggregating all fractional shares of Angion common stock issuable to such holder) will, in lieu of such fraction of a share and upon such holder’s surrender of a letter of transmittal in accordance with the Merger Agreement and any accompanying
documentation required therein, be paid in cash the dollar amount (rounded to the nearest whole cent), without interest, determined by multiplying such fraction by the volume weighted average closing trading price of a share of Angion common
stock on Nasdaq for the five consecutive trading days ending three trading days immediately prior to the date of the public announcement of the Merger Agreement, which is equal to $0.911.
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Exchange Ratio
The Exchange Ratio formula is derived based upon an Elicio fixed
valuation of $95 million and an Angion valuation of $50.1 million, subject to certain adjustments, including based upon Angion Net Cash (as defined below) at Closing.
Immediately following the Merger, the pre-Merger equity holders of
Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each
case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. As currently anticipated, the Exchange Ratio is expected to be approximately 0.0164, assuming
the reverse stock split is effected at a ratio of 10-for-1 to be implemented prior to the consummation of the Merger, as may be adjusted, and, subject to certain additional adjustments including based on the Angion Net Cash as of the
Anticipated Closing Date, to account for any outstanding liabilities or other obligations of Angion, as of the Anticipated Closing Date related to (i) that certain Agreement of Lease, dated as of June 21, 2011, by and between NovaPark LLC, as
landlord, and Angion, as tenant, with respect to a portion of 7-57 Wells Avenue, Newton, Massachusetts 02459, (ii) that certain Lease Agreement, dated as of January 20, 2021, by and between AG-JCCM Wells Avenue Property Owner, LLC, as landlord,
and Angion, as tenant, with respect to that certain space at 7-57 Wells Avenue, Newton, Massachusetts and (iii) that certain Master Lease Agreement, dated June 11, 2021 by and between CSC Leasing Co. and Angion (Outstanding Lease Obligations)
and to account for the Reverse Stock Split of Angion common stock at a ratio to be mutually agreed to by Angion and Elicio in the range of one new share for every 5 to 30 shares outstanding (which reverse stock split ratio was assumed to be
10-for-1 for purposes of calculating the assumed Exchange Ratio). The Exchange Ratio is the quotient obtained by dividing (a) (i) the Elicio Valuation divided by (ii) the Elicio Outstanding Shares (as defined below) by (b) (i) the Angion
Valuation divided by (ii) the Angion Outstanding Shares, in which:
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“Elicio Valuation” means $95 million.
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“Elicio Outstanding Shares” means the total number of shares of Elicio capital stock outstanding immediately prior to the
Effective Time after giving effect to the Preferred Stock Conversion, expressed on a fully-diluted basis and as-converted to Elicio common stock basis, assuming, without limitation or duplication, (i) the exercise of all Elicio stock
options, Elicio restricted stock unit awards and Elicio warrants, in each case outstanding as of immediately prior to the Effective Time, and (ii) the issuance of shares of Elicio capital stock in respect of all other outstanding
options, restricted stock awards, restricted stock units, warrants or rights to receive such shares, whether conditional or unconditional and including any outstanding options, warrants, restricted stock awards, restricted stock units
or rights triggered by or associated with the consummation of the Merger (but excluding any shares of Elicio capital stock reserved for issuance other than with respect to outstanding Elicio warrants or Elicio stock options under the
Elicio Plans as of immediately prior to the Effective Time).
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“Angion Equity Value” means $21.05 million.
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“Angion Outstanding Shares” means, subject to, among other things, certain stock dividends, subdivisions, reclassifications,
recapitalizations, splits (including the possibility to effect the Reverse Stock Split), combinations or exchanges of shares or other like changes occurring prior to the Effective Time and the exclusion of out-of-the money Angion stock
options, the total number of shares of Angion common stock outstanding immediately prior to the Effective Time expressed on a fully-diluted and as-converted to Angion common stock basis and using the treasury stock method (and, for the
avoidance of doubt, includes all in-the-money Angion stock options and Angion warrants), but assuming, without limitation or duplication, the issuance of shares of Angion common stock in respect of all Angion stock options, Angion
restricted stock units, Angion warrants and other outstanding options, warrants or rights to receive such shares, in each case, outstanding as of immediately prior to the Effective Time (assuming cashless exercise using the Angion
Closing Price), whether conditional or unconditional and including any outstanding options, warrants or rights triggered by or associated with the consummation of the Merger (but excluding any shares of Angion common stock reserved for
issuance other than with respect to outstanding Angion stock options, Angion restricted stock units and Angion warrants as of immediately prior to the Effective Time and as set forth above). No out-of-the-money Angion stock options or
Angion warrants will be included in the total number of shares of Angion common stock outstanding for purposes of determining the Angion Outstanding Shares.
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“Angion Valuation” means (i) if Angion Net Cash is greater than $31.5 million, the sum of (w) the Angion Equity Value plus (x) $29 million plus (y) the amount by which Angion Net Cash exceeds $31.5 million minus (z) the amount of
any Outstanding Lease Obligations as of the Anticipated Closing Date, (ii) if Angion Net Cash is greater than or equal to $26.5 million but less than or equal to $31.5 million, the sum of (x) the Angion Equity Value plus (y) $29 million minus (z) the amount of any Outstanding Lease Obligations as of the Anticipated Closing Date, or (iii) if Angion Net Cash is less than
$26.5 million, the sum of (w) the Angion Equity Value plus (x) $29 million minus (y) the amount by which $26.5 million exceeds Angion Net Cash minus (z) the amount of any Outstanding Lease Obligations as of the Anticipated Closing Date.
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“Angion Net Cash” means, without duplication, (a) the sum of (i) Angion’s cash and cash equivalents, and marketable
securities in each case as of the Anticipated Closing Date, (ii) the amount of any security deposits under leases or rental agreements to the extent refundable to Angion, (iii) the pro rata portion of any expenses prepaid by Angion
(x) that will benefit Angion after Closing (subject to Elicio’s due diligence reasonably confirming Angion will in fact receive such benefit) or (y) for which the parties agree that Angion will be contractually entitled to receive upon
termination of applicable contracts that the parties agree will be terminated as of or promptly after Closing (including, without limitation, prepaid expenses with respect to insurance to the extent that the parties agree that Angion
will terminate such insurance and be contractually entitled to a refund of such prepaid expenses), (iv) any net cash proceeds of the Asset Dispositions (as defined in the section titled “Merger
Agreement—Potential Asset Disposition”) which Angion is contractually entitled as of the Closing Date (subject to no conditions other than the passage of time) to receive within 90 days of the Closing Date and (v) 50% of (A)
the aggregate costs associated with stockholder litigation brought or threatened in writing against Angion or its directors or officers relating to the Contemplated Transactions and (B) the fees associated with the listing on Nasdaq of
the additional shares of Angion common stock to be issued in connection with the Contemplated Transactions, minus (b) the sum of (i) Angion’s accounts payable, accrued expenses (other than
accrued expenses which are Transaction Expenses, as defined below, of Angion) and other current liabilities (excluding a recorded liability of approximately $160,000 for potential patient recruitment bonuses from a terminated clinical
study that will not be realized (subject to Elicio’s due diligence reasonably confirming such bonuses will not be realized)) payable in cash, in each case as of the Anticipated Closing Date and determined in a manner consistent with the
manner in which such items were historically determined and in accordance with Angion’s audited financial statements and the unaudited balance sheet of Angion as of September 30, 2022, included in Angion’s Report on Form 10-Q for the
quarterly period ended September 30, 2022, as filed with the SEC, (ii) any unpaid Transaction Expenses (as defined in “—Expenses”) of Angion, (iii) any unpaid amounts payable by Angion in
satisfaction of its obligations related to the directors’ and officers’ liability tail policy for the period after Closing, (iv) the amount of any Outstanding Lease Obligations, and (v) any declared but unpaid Angion cash dividends, plus (c) the aggregate amount of any outstanding principal and accrued interest under the Angion Notes as of the Anticipated Closing Date (but in no event will such amount be counted twice in the
calculation of Angion Net Cash). The parties agreed that in no case will Angion Net Cash be reduced for any costs or expenses, including attorney’s fees or settlement costs, incurred in connection with any dissenting shares.
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The following table illustrates how the Exchange Ratio and
post-Merger equity ownership of Elicio’s pre-Merger equity holders and Angion’s pre-Merger equity holders may change (including deduction for the Outstanding Lease Obligations) if Angion Net Cash is between $23 million and $32 million at
Closing, in each case calculated as of the Anticipated Closing Date.
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Post-Merger Ownership
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Angion Net Cash at Closing
($ in millions)
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Exchange Ratio
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Angion Equity Holders
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Elicio Equity Holders
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$23 million
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0.0176
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31.7%
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68.3%
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$23.5 million
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0.0174
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31.9%
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68.1%
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$24 million
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0.0172
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32.2%
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67.8%
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$24.5 million
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0.0171
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32.4%
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67.6%
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$25 million
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0.0169
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32.6%
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67.4%
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$25.5 million
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0.0167
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32.9%
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67.1%
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Post-Merger Ownership
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Angion Net Cash at Closing
($ in millions)
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Exchange Ratio
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Angion Equity Holders
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Elicio Equity Holders
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$26 million
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0.0166
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33.1%
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66.9%
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$26.5 million
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0.0164
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33.4%
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66.6%
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$27 million
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0.0164
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33.6%
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66.4%
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$27.5 million
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0.0164
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33.8%
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66.2%
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$28 million
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0.0164
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34.1%
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65.9%
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$28.5 million
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0.0164
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34.3%
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65.7%
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$29 million
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0.0164
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34.5%
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65.5%
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$29.5 million
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0.0164
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34.7%
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65.3%
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$30 million
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0.0164
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35%
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65.0%
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$30.5 million
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0.0164
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35.2%
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64.8%
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$31 million
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0.0164
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35.4%
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64.6%
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$31.5 million
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0.0164
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35.6%
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64.4%
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$32 million
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0.0162
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35.8%
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64.2%
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Under the terms of the Merger Agreement, each option to purchase
shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, if any, whether or not vested, will be converted into and become an option to purchase shares of Angion common stock. Angion will assume
the Elicio Plans and all such Elicio stock options in accordance with the terms of the Elicio Plans and the terms of the stock option agreement by which such option is evidenced.
Accordingly, from and after the Effective Time: (i) each
outstanding Elicio stock option assumed by Angion may be exercised solely for shares of Angion common stock; (ii) the number of shares of Angion common stock subject to each outstanding Elicio stock option assumed by Angion will be determined
by multiplying (A) the number of shares of Elicio common stock that were subject to such Elicio stock option, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio, and rounding the resulting number down to the nearest
whole number of shares of Angion common stock; (iii) the per share exercise price for the Angion common stock issuable upon exercise of each Elicio stock option assumed by Angion will be determined by dividing (A) the per share exercise price
of Angion common stock subject to such Elicio stock option, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio and rounding the resulting exercise price up to the nearest whole cent; and (iv) any restriction on the
exercise of any Elicio stock option assumed by Angion will continue in full force and effect and the term, exercisability, vesting schedule, accelerated vesting provisions, and any other provisions of such Elicio stock option will otherwise
remain unchanged; provided, however, that the Angion Board or a committee thereof will succeed to the authority and responsibility of the Elicio Board or any committee thereof with respect to each Elicio stock option assumed by Angion.
Under the terms of the Merger Agreement, each warrant to purchase
shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, will be converted into and become a warrant to purchase shares of Angion common stock and Angion will assume each Elicio warrant in
accordance with its terms.
Accordingly, from and after the Effective Time: (i) each
outstanding Elicio warrant assumed by Angion may be exercised solely for shares of Angion common stock; (ii) the number of shares of Angion common stock subject to each outstanding Elicio warrant assumed by Angion will be determined by
multiplying (A) the number of shares of Elicio common stock, or the number of shares of Elicio preferred stock issuable upon exercise of the Elicio warrant, as applicable, that were subject to such Elicio warrant immediately prior to the
Effective Time, by (B) the Exchange Ratio, and rounding the resulting number down to the nearest whole number of shares of Angion common stock; (iii) the per share exercise price for the Angion common stock issuable upon exercise of each Elicio
warrant assumed by Angion will be determined by dividing (A) the per share exercise price of Elicio capital stock subject to such Elicio warrant, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio and rounding the
resulting exercise price up to the nearest whole cent; and (iv) any restriction on the exercise of any Elicio warrant assumed by Angion will continue in full force and effect and the term and other provisions of such Elicio warrant will
otherwise remain unchanged.
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The Merger Agreement provides that the parties will use reasonable
best efforts and take all necessary action so that effective as of the Effective Time, the Board of Directors of the combined company (the Combined Company Board) is comprised of nine members, with six such members designated by Elicio and
three such members designated by Angion. Mr. Connelly, Chief Executive Officer of Elicio, will serve as the Chief Executive Officer of the combined company, Mr. Geffken, Interim Chief Financial Officer of Elicio will serve as Interim Chief
Financial Officer of the combined company, Dr. Haqq who serves as Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio, will serve in the same role at the combined company, Dr. Matthies, Chief Business
Officer of Elicio will serve as Chief Business Officer of the combined company and Dr. DeMuth, Chief Scientific Officer of Elicio, will serve as Chief Scientific Officer of the combined company. For more information about the directors and
executive officers of the combined company following the Merger, please see the sections titled “The Merger—Executive Officers of the Combined Company Following the Merger” and “The Merger—Directors of the Combined Company Following the Merger.”
The obligations of each party to consummate the Merger and the
Contemplated Transactions are subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by each of the parties, at or prior to the Closing, of the following conditions:
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there must not have been any temporary restraining order, preliminary or permanent injunction or other order preventing the
consummation of the Contemplated Transactions issued by any court of competent jurisdiction or other governmental body of competent jurisdiction and that remains in effect, and no law may have made the consummation of the Contemplated
Transactions illegal;
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the Angion stockholders must have approved (i) the amendment to Angion’s certificate of incorporation to effect the Reverse
Stock Split, (ii) if applicable, the consummation of the Asset Dispositions and (iii) the issuance of Angion common stock or other securities of Angion that represent (or are convertible into) more than 20% of the shares of Angion
common stock outstanding immediately prior to the Merger to the holders of Elicio capital stock, Elicio stock options and Elicio warrants in connection with the Contemplated Transactions and the change of control of Angion resulting
from the Contemplated Transactions, in each case pursuant to the Nasdaq rules;
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Elicio must have delivered an action by written consent (Elicio Stockholder Written Consent) executed by the holders of (a) a
majority of the then outstanding shares of Elicio Series A Preferred Stock voting as a separate class; (b) a majority of the then outstanding shares of Elicio Series B Preferred Stock voting as a separate class; (c) a majority of the
then outstanding shares of Elicio Series C Preferred Stock voting as a separate class; and (d) a majority of the then outstanding shares of Elicio capital stock on an as-converted to Elicio common stock basis (collectively, the Required
Elicio Stockholder Vote): (i) adopting and approving the Merger Agreement and the Contemplated Transactions, (ii) acknowledging that the approval given thereby is irrevocable and that such stockholder is aware of its rights to demand
appraisal, or assert any dissenters’ rights, for its shares pursuant to Section 262 of the DGCL and that such stockholder has received and read a copy of Section 262 of the DGCL, (iii) acknowledging that by such stockholder’s approval
of the Merger such stockholder is not entitled to appraisal rights and thereby waives any right to receive payment of the fair value of its shares of Elicio capital stock under the DGCL, and (iv) electing an automatic conversion of each
share of Elicio preferred stock into shares of Elicio common stock immediately prior to the Effective Time in accordance with the relevant provisions of Elicio’s organizational documents.
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the existing shares of Angion common stock must have been continually listed on Nasdaq as of and from the date of the Merger
Agreement through the Closing Date and the shares of Angion common stock to be issued in the Merger pursuant to the Merger Agreement must have been approved for listing (subject to official notice of issuance) on Nasdaq as of Closing;
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this Registration Statement must have become effective in accordance with the Securities Act and must not be subject to any
stop order or proceeding (or threatened proceeding by the SEC) seeking a stop order with respect to the Registration Statement that not been withdrawn; and
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Angion Net Cash must have been finally determined in accordance with the Merger Agreement.
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139
In addition, the obligation of Angion and Merger Sub to
consummate the Merger is further subject to the satisfaction or waiver of the following conditions:
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the representations and warranties of Elicio set forth in the Merger Agreement under Sections 2.1 (Due Organization;
Subsidiaries), 2.3 (Authority; Binding Nature of Agreement), 2.4 (Vote Required), 2.6(a) and (c) (Capitalization) and 2.20 (No Financial Advisors) must have been true and correct in all material respects as of the date of the Merger
Agreement and must be true and correct in all material respects on and as of the Closing Date with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically
made as of a particular date, in which case such representations and warranties must have been true and correct in all material respects as of such date);
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the representations and warranties of Elicio set forth in the Merger Agreement (other than the Elicio representations and
warranties listed above) must have been true and correct as of the date of the Merger Agreement and must be true and correct on and as of the Closing Date with the same force and effect as if made on and as of the Closing Date except
(a) in each case, or in the aggregate, where the failure to be so true and correct would not reasonably be expected to have an Elicio Material Adverse Effect (as defined below) (without giving effect to any references therein to any
Elicio Material Adverse Effect or other materiality qualifications) or (b) for those representations and warranties which address matters only as of a particular date (which representations must have been true and correct, subject to
the qualifications set forth in the preceding clause (a), as of such particular date);
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Elicio must have performed or complied with in all material respects all agreements and covenants required to be performed or
complied with by it under the Merger Agreement at or prior to the Effective Time;
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Angion must have received from Elicio (i) an officer’s certificate certifying (x) that certain conditions set forth in the
Merger Agreement have been duly satisfied and (y) that the information set forth in an allocation certificate delivered by Elicio containing information regarding Elicio’s capitalization is true and accurate in all respects; and (ii) a
copy of such allocation certificate;
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since the date of the Merger Agreement, there must not have occurred an Elicio Material Adverse Effect that is continuing;
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certain of Elicio’s investor agreements must have been terminated (or will be terminated as of the Closing);
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Angion must have received duly executed copies of the required Lock-Up Agreements from certain stockholders of Elicio and
each executive officer and director of Elicio who is elected or appointed, as applicable, as an executive officer or director of Angion as of immediately following Closing, each of which must be in full force and effect as of Closing;
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•
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the Elicio Stockholder Written Consent executed by certain officers, directors and stockholders of Elicio must be in full
force and effect;
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the holders of no more than 5% of the shares of Elicio capital stock will have exercised statutory appraisal rights pursuant
to Section 262 of the DGCL with respect to their shares of Elicio capital stock; and
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Angion must have received (i) an original signed statement from Elicio that Elicio is not, and has not been at any time
during the applicable period specified in Section 897(c)(1)(A)(ii) of the Code, a “United States real property holding corporation,” as defined in Section 897(c)(2) of the Code, conforming to the requirements of Treasury Regulations
Section 1.1445-2(c)(3) and 1.897-2(h), and (ii) an original signed notice from Elicio to be delivered to the IRS in accordance with the provisions of Treasury Regulations Section 1.897-2(h)(2), together with written authorization for
Angion to deliver such notice to the IRS on behalf of Elicio following Closing, each dated as of the Closing Date, duly executed by an authorized officer of Elicio, and in form and substance reasonably acceptable to Angion.
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In addition, the obligation of Elicio to consummate the Merger is
further subject to the satisfaction or waiver of the following conditions:
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•
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the representations and warranties of Angion and Merger Sub set forth in the Merger Agreement under Sections 3.1 (Due
Organization; Subsidiaries), 3.3 (Authority; Binding Nature of Agreement), 3.4 (Vote Required), 3.6(a) and (c) (Capitalization) and 3.21 (No Financial Advisors) must have been true and correct
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140
in all material respects as of the date of the Merger Agreement and must be true
and correct in all material respects on and as of the Closing Date with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically made as of a particular date, in
which case such representations and warranties must have been true and correct in all material respects as of such date);
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•
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the representations and warranties of Angion and Merger Sub set forth in the Merger Agreement (other than the Angion and
Merger Sub representations and warranties listed above) must have been true and correct as of the date of the Merger Agreement and must be true and correct on and as of the Closing Date with the same force and effect as if made on and
as of the Closing Date except (a) in each case, or in the aggregate, where the failure to be so true and correct would not reasonably be expected to have an Angion Material Adverse Effect (as defined below) (without giving effect to any
references therein to any Angion Material Adverse Effect or other materiality qualifications) or (b) for those representations and warranties which address matters only as of a particular date (which representations must have been true
and correct, subject to the qualifications as set forth in the preceding clause (a), as of such particular date);
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•
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Angion and Merger Sub must have performed or complied with in all material respects all of their agreements and covenants
required to be performed or complied with by each of them under the Merger Agreement at or prior to the Effective Time;
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•
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Elicio must have received from Angion (i) an officer’s certificate confirming that certain conditions of the Merger Agreement
have been duly satisfied; (ii) a certificate containing information regarding Angion’s capitalization; (iii) a written resignation executed by the directors of Angion who will not continue as directors of Angion after Closing; and
(iv) the Angion closing financial certificate certifying Angion Net Cash as of the Anticipated Closing Date, a draft of which must have been provided to Elicio at least five business days prior to Closing, which certificate will be
accompanied by such supporting documentation, information and calculations as are reasonably requested by Elicio to verify and determine the information contained therein;
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•
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since the date of the Merger Agreement, there must not have occurred an Angion Material Adverse Effect that is continuing;
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•
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Angion Net Cash must be greater than or equal to $25 million;
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•
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Elicio must have received satisfactory evidence that (a) specified Angion contracts have been terminated, assigned or fully
performed by Angion, and (b) all obligations of Angion thereunder have been fully satisfied, waived or otherwise discharged; and
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•
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the Lock-Up Agreements executed by certain officers, directors and stockholders of Angion must be in full force and effect as
of immediately following the Effective Time.
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“Angion Material Adverse Effect” means any effect, change, event,
circumstance or development (collectively, Effect) that, considered together with all other Effects, has or would reasonably be expected to have a material adverse effect on the business, condition (financial or otherwise), assets, liabilities
or results of operations of Angion or its subsidiaries, taken as a whole; provided, however, that Effects arising or resulting from the following will not be taken into account in determining whether there has been an Angion Material Adverse
Effect: (a) general business, political or economic conditions generally affecting the industry in which Angion and its subsidiaries operate, (b) acts of war, the outbreak or escalation of armed hostilities, acts of terrorism, earthquakes,
wildfires, hurricanes or other natural disasters, health emergencies, including pandemics (including COVID-19 and any evolutions or mutations thereof) and related or associated epidemics, disease outbreaks or quarantine restrictions, (c)
changes in financial, banking or securities markets, (d) any change in the stock price or trading volume of Angion common stock (it being understood, however, that any Effect causing or contributing to any change in stock price or trading
volume of Angion common stock may be taken into account in determining whether an Angion Material Adverse Effect has occurred, unless such Effects are otherwise excepted from this definition), (e) the failure of Angion to meet internal or
analysts’ expectations or projections or the results of operations of Angion, (f) any changes in or affecting clinical trial programs or studies conducted by or on behalf of Angion or its subsidiaries, including any adverse data, event or
outcome arising out of or related to any such programs or studies, (g) any change in, or any compliance with or action taken for the purpose of complying with, any law or GAAP (or interpretations of any law or GAAP), (h) the announcement of the
Merger Agreement or the pendency of the Contemplated Transactions, (i) the Asset
141
Dispositions, (j) any reduction in the amount of Angion’s cash and cash
equivalents as a result of expenditures made by Angion related to wind down activities of Angion associated with the termination of its research and development activities (including the termination of ongoing contractual obligations relating
to Angion current products or product candidates), (k) resulting from the taking of any action required to be taken by the Merger Agreement, or (l) as set forth on Section B of Angion’s disclosure schedule, except in each case, with respect to
clauses (a) through (c), to the extent disproportionately affecting Angion and its subsidiaries, taken as a whole, relative to other similarly situated companies in the industries in which Angion and its subsidiaries operate.
“Elicio Material Adverse Effect” means any Effect that, considered
together with all other Effects, has or would reasonably be expected to have a material adverse effect on the business, condition (financial or otherwise), assets, liabilities or results of operations of Elicio or its subsidiaries, taken as a
whole; provided, however, that Effects arising or resulting from the following will not be taken into account in determining whether there has been an Elicio Material Adverse Effect: (a) general business, political or economic conditions
generally affecting the industry in which Elicio and its subsidiaries operate, (b) acts of war, the outbreak or escalation of armed hostilities, acts of terrorism, earthquakes, wildfires, hurricanes or other natural disasters, health
emergencies, including pandemics (including COVID-19 and any evolutions or mutations thereof) and related or associated epidemics, disease outbreaks or quarantine restrictions, (c) changes in financial, banking or securities markets, (d) any
change in, or any compliance with or action taken for the purpose of complying with, any law or GAAP (or interpretations of any law or GAAP), (e) the announcement of the Merger Agreement or the pendency of the Contemplated Transactions, (f) the
taking of any action required to be taken by the Merger Agreement, or (g) continued losses from operations or decreases in cash balances of Elicio or any of its subsidiaries or on a consolidated basis among Elicio and its subsidiaries; except,
in each case, with respect to clauses (a) through (c), to the extent disproportionately affecting Elicio and its subsidiaries, taken as a whole, relative to other similarly situated companies in the industries in which Elicio and its
subsidiaries operate.
At least 15 calendar days prior to the Angion special meeting of
stockholders, Angion and Elicio will agree upon the Anticipated Closing Date. At least ten calendar days prior to the Angion special meeting of stockholders, Angion will deliver to Elicio the Net Cash Schedule setting forth, in reasonable
detail, Angion’s good faith, estimated calculation of Angion Net Cash, including each component thereof, as of the Anticipated Closing Date, prepared and certified by Angion’s Chief Financial Officer (or, if there is no Chief Financial Officer,
the principal accounting officer of Angion), and shall make available to Elicio the work papers and back-up materials used or useful in preparing the Net Cash Schedule and, as reasonably requested by Elicio, Angion’s accountants and counsel at
reasonable times and upon reasonable notice. Within three business days after delivery of the Net Cash Schedule (Response Date), Elicio will have the right to dispute any part of the Net Cash Schedule by delivering a written notice to that
effect to Angion (a Dispute Notice). Any Dispute Notice will identify in reasonable detail the nature of any proposed revisions to the Angion Net Cash calculation.
If on or prior to the Response Date, Elicio (i) notifies Angion in
writing that it has no objections to the Angion Net Cash calculation or (ii) fails to deliver a Dispute Notice, then the Angion Net Cash calculation as set forth in the Net Cash Schedule will be deemed to have been finally determined for
purposes of the Merger Agreement and to represent Angion Net Cash as of the Anticipated Closing Date for purposes of the Merger Agreement.
If Elicio delivers a Dispute Notice on or prior to the Response
Date, then representatives of both parties will promptly meet and attempt in good faith to resolve the disputed item(s) and negotiate an agreed-upon determination of Angion Net Cash, which agreed upon Angion Net Cash amount will be deemed to
have been finally determined for purposes of the Merger Agreement and to represent the Angion Net Cash, as of the Anticipated Closing Date for purposes of the Merger Agreement.
If Angion and Elicio are unable to negotiate an agreed-upon
determination of Angion Net Cash, as of the Anticipated Closing Date, within three calendar days after delivery of the Dispute Notice (or such other period as Angion and Elicio may mutually agree upon), then Angion and Elicio will jointly
select an independent auditor of recognized national standing (Accounting Firm) to resolve any remaining disagreements as to the Angion Net Cash calculation. Angion will promptly deliver to the Accounting Firm the work papers and back-up
materials used or useful in preparing the Net Cash Schedule, and Angion and Elicio will use commercially reasonable efforts to cause the Accounting Firm to make its determination within 10 calendar days of accepting its selection. Angion and
Elicio will be afforded the opportunity to present to the Accounting Firm any material related to the unresolved disputes and
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to discuss the issues with the Accounting Firm;
provided, however, that no such presentation or discussion will occur without the presence of a representative of each of Angion and Elicio. The determination of the Accounting Firm will be limited to the disagreements submitted to the
Accounting Firm. The determination of the amount of Angion Net Cash, made by the Accounting Firm will be final and binding upon the parties and deemed to have been finally determined for purposes of the Merger Agreement and to represent Angion
Net Cash as of the Anticipated Closing Date for purposes of the Merger Agreement, and the parties will delay the Closing until the resolution of the Angion Net Cash calculation. The fees and expenses of the Accounting Firm will be allocated
between Angion and Elicio in the same proportion that the disputed amount of Angion Net Cash that was unsuccessfully disputed by such party (as finally determined by the Accounting Firm) bears to the total disputed amount of Angion Net Cash. If
the determination of Angion Net Cash as of the Anticipated Closing Date is done in accordance with this paragraph, the parties will not be required to determine Angion Net Cash, again even though the Closing may occur later than the Anticipated
Closing Date, except that either party may request a re-determination of Angion Net Cash if the Closing Date is more than five business days after the Anticipated Closing Date.
Angion is entitled, but under no obligation, to sell, transfer,
license, assign or otherwise divest its intellectual property and other assets and technology in existence on the date of the Merger Agreement (Potentially Transferrable Assets) to one or more third parties in one or a series of transactions
prior to or substantially concurrently with Closing (Asset Dispositions); provided, that any such Asset Disposition will require, to the extent consistent with applicable laws, the written consent of Elicio, not to be unreasonably withheld,
conditioned or delayed, if such Asset Disposition would create any post-disposition material liabilities for Angion following Closing. If the Asset Dispositions are not completed prior to, concurrently with, or immediately following Closing,
the Potentially Transferrable Assets will be retained by Angion.
The Merger Agreement contains customary representations and
warranties of the parties. Elicio represents and warrants to the following matters:
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Due Organization; Subsidiaries
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Organizational Documents
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Authority; Binding Nature of Agreement
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Vote Required
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Non-Contravention; Consents
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Capitalization
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Financial Statements
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Absence of Changes
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Absence of Undisclosed Liabilities
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Title to Assets
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Real Property; Leasehold
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Intellectual Property
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Agreements, Contracts and Commitments
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Compliance; Permits; Restrictions
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Legal Proceedings; Orders
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Tax Matters
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Employee and Labor Matters; Benefit Plans
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Environmental Matters
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Insurance
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No Financial Advisors
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Disclosure
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Transactions with Affiliates
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Anti-Bribery
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Disclaimer of Other Representations and Warranties
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Angion and Merger Sub represent and warrant to the following matters:
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Due Organization; Subsidiaries
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Organizational Documents
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Authority; Binding Nature of Agreement
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Vote Required
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Non-Contravention; Consents
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Capitalization
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SEC Filings; Financial Statements
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Absence of Changes
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Absence of Undisclosed Liabilities
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Title to Assets
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Real Property; Leasehold
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Intellectual Property
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Agreements, Contracts and Commitments
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Compliance; Permits; Restrictions
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Legal Proceedings; Orders
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Tax Matters
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Employee and Labor Matters; Benefit Plans
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Environmental Matters
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Transactions with Affiliates
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Insurance
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No Financial Advisors
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Disclosure
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Anti-Bribery
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Valid Issuance
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Opinion of Financial Advisor
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Disclaimer of Other Representations and Warranties
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The representations and warranties of Elicio, Angion and Merger
Sub contained in the Merger Agreement or any certificate or instrument delivered pursuant to the Merger Agreement will terminate at the Effective Time.
Angion, Elicio and their respective subsidiaries are prohibited by
the terms of the Merger Agreement, other than, in the case of Angion, with respect to any Asset Disposition, from, directly or indirectly, (i) soliciting, initiating or knowingly encouraging, inducing or facilitating the communication, making,
submission or announcement of any
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Acquisition Proposal (as defined below) or Acquisition Inquiry (as defined below)
or taking any action that could reasonably be expected to lead to an Acquisition Proposal or Acquisition Inquiry; (ii) furnishing any non-public information regarding such party to any person in connection with or in response to an Acquisition
Proposal or Acquisition Inquiry; (iii) engaging in discussions (other than to inform any person of the existence of these prohibitions) or negotiations with any person with respect to any Acquisition Proposal or Acquisition Inquiry;
(iv) approving, endorsing or recommending any Acquisition Proposal; (v) executing or entering into any letter of intent or any contract contemplating or otherwise relating to any Acquisition Transaction (as defined below) (other than, in the
case of Angion, a confidentiality agreement permitted as described below); or (vi) publicly proposing to do any of the foregoing.
Pursuant to the terms of the Merger Agreement, each of Angion and
Elicio agreed to immediately cease and cause to be terminated any existing discussions, negotiations and communications with any person relating to any Acquisition Proposal or Acquisition Inquiry (other than, in the case of Angion, any Asset
Dispositions) as of the date of the Merger Agreement and request the destruction or return of any of such party’s nonpublic information provided to such person as soon as practicable after the date of the Merger Agreement.
Subject to certain restrictions and prior to obtaining the
approval of the Stock Issuance Proposal and the Reverse Stock Split Proposal (Required Angion Closing Stockholder Matters) by the Required Angion Stockholder Vote (as defined below), Angion and its subsidiaries may furnish non-public
information regarding Angion or any of its subsidiaries to, and enter into discussions or negotiations with, any person in response to a bona fide Acquisition Proposal by such person, which the Angion
Board determines in good faith, after consultation with its outside financial advisor and outside legal counsel, constitutes, or is reasonably likely to result in, a Superior Offer (as defined below) (and is not withdrawn) if: (A) none of
Angion, any of its subsidiaries or any of their respective representatives have breached the non-solicitation restrictions in the Merger Agreement in any material respect, (B) the Angion Board concludes in good faith based on the advice of
outside legal counsel, that the failure to take such action is reasonably likely to be inconsistent with the fiduciary duties of the Angion Board under applicable law; (C) substantially contemporaneously with furnishing any such nonpublic
information to such person, Angion gives Elicio notice of Angion’s intention to furnish nonpublic information to, or enter into discussions with, such person and furnishes such nonpublic information to Elicio (to the extent such information has
not been previously furnished by Angion to Elicio), and (D) Angion receives from such person an executed confidentiality agreement containing provisions (including nondisclosure provisions, use restrictions, non-solicitation provisions, no hire
and “standstill” provisions), in the aggregate, at least as favorable to it as those contained in the confidentiality agreement entered into between Angion and Elicio in connection with the Merger.
If Angion, Elicio, or any of their respective subsidiaries or
representatives, receives an Acquisition Proposal or Acquisition Inquiry during the period following the date of the Merger Agreement through Closing, then such party will promptly (and in no event later than one business day after such party
becomes aware of such Acquisition Proposal or Acquisition Inquiry) advise the other party orally and in writing of such Acquisition Proposal or Acquisition Inquiry (including the identity of the person making or submitting such Acquisition
Proposal or Acquisition Inquiry and the material terms thereof). Each party will keep the other party reasonably informed with respect to the status and material terms of any such Acquisition Proposal or Acquisition Inquiry and any material
modification or proposed material modification thereto.
“Acquisition Inquiry” means, with respect to a party, an inquiry,
indication of interest or request for information (other than an inquiry, indication of interest or request for information made or submitted by Elicio, on the one hand, or Angion, on the other hand, to the other party) that could reasonably be
expected to lead to an Acquisition Proposal; provided, however, that the term Acquisition Inquiry does not include the Merger, the Contemplated Transactions or any transactions related to the Asset Dispositions.
“Acquisition Proposal” means, with respect to a party, any offer
or proposal, whether written or oral (other than an offer or proposal made or submitted by or on behalf of Elicio or any of its affiliates, on the one hand, or by or on behalf of Angion or any of its affiliates, on the other hand, to the other
party) contemplating or otherwise relating to any Acquisition Transaction with such party, other than the Asset Dispositions.
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“Acquisition Transaction” means any transaction or series of
related transactions (other than the Asset Dispositions) involving:
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any merger, consolidation, amalgamation, share exchange, business combination, issuance of securities, acquisition of
securities, reorganization, recapitalization, tender offer, exchange offer or other similar transaction: (i) in which a party is a constituent entity; (ii) in which a person or “group” (as defined in the Exchange Act and the rules
promulgated thereunder) of persons directly or indirectly acquires beneficial or record ownership of securities representing more than 20% of the outstanding securities of any class of voting securities of a party or any of its
subsidiaries; or (iii) in which a party or any of its subsidiaries issues securities representing more than 20% of the outstanding securities of any class of voting securities of such party or any of its subsidiaries; or
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any sale, lease, exchange, transfer, license, acquisition or disposition of any business or businesses or assets that
constitute or account for 20% or more of the consolidated book value or the fair market value of the assets of a party and its subsidiaries, taken as a whole.
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“Superior Offer” means an unsolicited bona fide written
Acquisition Proposal (with all references to 20% in the definition of Acquisition Transaction being treated as references to greater than 50% for these purposes) that: (a) was not obtained or made as a direct or indirect result of a breach of
(or in violation of) the Merger Agreement; and (b) is on terms and conditions that the Angion Board determines in good faith, based on such matters that it deems relevant (including the likelihood of consummation thereof and the financing terms
thereof), as well as any written offer by the other party to the Merger Agreement to amend the terms of the Merger Agreement, and following consultation with its outside legal counsel and outside financial advisor, if any, are more favorable,
from a financial point of view, to Angion’s stockholders than the terms of the Contemplated Transactions and is not subject to any financing condition (and if financing is required, such financing is then fully committed to the third party).
Promptly after the Registration Statement has been declared
effective by the SEC under the Securities Act, Angion will take all action necessary under applicable law to call, give notice of and hold a meeting of the holders of Angion common stock for the purpose of seeking approval of the Merger
Agreement and the Contemplated Transactions, including: (i) the amendment of Angion’s certificate of incorporation to effect the Reverse Stock Split, (ii) if applicable, the consummation of the Asset Dispositions, (iii) the issuance of Angion
common stock or other securities of Angion that represent (or are convertible into) more than 20% of the shares of Angion common stock outstanding immediately prior to the Merger to the holders of Elicio capital stock, Elicio stock options and
Elicio warrants in connection with the Contemplated Transactions and the change of control of Angion resulting from the Contemplated Transactions, in each case pursuant to the Nasdaq rules, and (iv) any other proposals the parties deem
necessary or desirable to consummate the Contemplated Transactions (together with the proposals set forth in the foregoing clauses (i) through (iii), the Angion Stockholder Matters).
The Angion special meeting will be held as promptly as practicable
after the Registration Statement is declared effective under the Securities Act and, in any event, no later than 45 calendar days after the effective date of the Registration Statement. Angion will take reasonable measures to ensure that all
proxies solicited in connection with the Angion special meeting are solicited in compliance with all applicable laws. If, on or before the date of the Angion special meeting, Angion reasonably believes that it (i) will not receive proxies
sufficient to obtain the required approvals of the Required Angion Closing Stockholder Matters (Required Angion Stockholder Vote), whether or not a quorum would be present or (ii) will not have sufficient shares of Angion common stock
represented (whether in person or by proxy) to constitute a quorum necessary to conduct the business of the Angion special meeting, Angion may postpone or adjourn, or make one or more successive postponements or adjournments of, the Angion
special meeting as long as the date of the Angion special meeting is not postponed or adjourned more than an aggregate of 60 calendar days in connection with any postponements or adjournments.
Angion agreed that, subject to certain exceptions in the Merger
Agreement: (i) the Angion Board will recommend that the holders of Angion common stock vote to approve the Angion Stockholder Matters and will use commercially reasonable efforts to solicit such approval within the timeframe set forth above,
(ii) this proxy statement/prospectus/information statement will include a statement to the effect that the Angion Board recommends that Angion’s stockholders vote to approve the Angion Stockholder Matters (the recommendation of the Angion Board
with respect to the Angion Stockholder Matters being referred to as the Angion Board Recommendation); and (iii) the Angion Board Recommendation will not be withheld, amended, withdrawn or modified (and the Angion
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Board will not publicly propose to withhold, amend, withdraw or modify the Angion
Board Recommendation) in a manner adverse to Elicio, and no resolution by the Angion Board or any committee thereof to withdraw or modify the Angion Board Recommendation in a manner adverse to Elicio or to adopt, approve or recommend (or
publicly propose to adopt, approve or recommend) any Acquisition Proposal shall be adopted or proposed (the actions set forth in the foregoing clause (iii), collectively, an Angion Board Adverse Recommendation Change).
The terms of the Merger Agreement provide that, subject to the
limitations set forth in the Merger Agreement, if at any time prior to the approval of the Angion Stockholder Matters at the Angion special meeting by the Required Angion Stockholder Vote, Angion receives a bona
fide Acquisition Proposal (which did not arise out of a material breach of the non-solicitation provisions of the Merger Agreement) from any person that has not been withdrawn and after consultation with outside legal counsel, the
Angion Board determines, in good faith, that such Acquisition Proposal is a Superior Offer, the Angion Board may make an Angion Board Adverse Recommendation Change or Angion may terminate the Merger Agreement to enter into a definitive
agreement with respect to such Superior Offer, if and only if: (A) the Angion Board determines in good faith, after consultation with Angion’s outside legal counsel, that the failure to do so would be reasonably likely to be inconsistent with
the fiduciary duties of the Angion Board to Angion’s stockholders under applicable law; (B) Angion has given Elicio prior written notice of its intention to consider making an Angion Board Adverse Recommendation Change or terminate the Merger
Agreement to enter into a definitive agreement with respect to such Superior Offer at least four business days prior to making any such Angion Board Adverse Recommendation Change or termination (an Angion Determination Notice, and such period,
the Angion Notice Period) (which notice will not constitute an Angion Board Adverse Recommendation Change); and (C)(1) Angion provided to Elicio a summary of the material terms and conditions of the Acquisition Proposal in accordance with the
Merger Agreement, (2) Angion has and has caused its representatives to, during the Angion Notice Period, negotiate in good faith with Elicio (to the extent Elicio desires to negotiate) to enable Elicio to propose in writing an offer binding on
Elicio to effect such adjustments to the terms and conditions of the Merger Agreement so that such Acquisition Proposal no longer constitutes a Superior Offer, and (3) after considering the results of such negotiations and giving effect to the
proposals made by Elicio, if any, after consultation with outside legal counsel, the Angion Board determines, in good faith, that such Acquisition Proposal is a Superior Offer and that the failure to make the Angion Board Adverse Recommendation
Change or terminate the Merger Agreement to enter into a definitive agreement with respect to such Superior Offer would be inconsistent with the fiduciary duties of the Angion Board to Angion’s stockholders under applicable law; provided that
(x) Elicio receives written notice from Angion confirming that the Angion Board has determined to change its recommendation during the Angion Notice Period, which shall include a description in reasonable detail of the reasons for such Angion
Board Adverse Recommendation Change and written copies of any relevant proposed transaction agreements with any party making a potential Superior Offer or to terminate the Merger Agreement pursuant to the terms set forth therein during the
Angion Notice Period; (y) during any Angion Notice Period, Elicio shall be entitled to deliver to Angion one or more counterproposals to such Acquisition Proposal and Angion will, and will cause its representatives to, negotiate with Elicio in
good faith (to the extent Elicio desires to negotiate) to enable Elicio to propose in writing an offer binding on Elicio to effect such adjustments to the terms and conditions of the Merger Agreement so that the applicable Acquisition Proposal
ceases to constitute a Superior Offer; and (z) in the event of any material amendment to any Superior Offer (including any revision in price or percentage of the combined company that Angion’s stockholders would receive), Angion must provide
Elicio with notice of such material amendment and the Angion Notice Period will be extended, if applicable, to ensure that at least two business days remain in the Angion Notice Period (it being understood that there may be multiple
extensions).
The terms of the Merger Agreement also provide that, other than in
connection with an Acquisition Proposal, the Angion Board may make an Angion Board Adverse Recommendation Change in response to an Angion Change in Circumstance (as defined below), if and only if: (A) the Angion Board determines in good faith,
after consultation with the Angion’s outside legal counsel, that the failure to do so would be reasonably likely to be inconsistent with the fiduciary duties of the Angion Board to Angion’s stockholders under applicable law; (B) Angion has
given Elicio an Angion Determination Notice at least four business days prior to making any such Angion Board Adverse Recommendation Change; and (C) (1) Angion has specified the Angion Change in Circumstance in reasonable detail, including the
material facts and circumstances related to the applicable Angion Change in Circumstance, (2) Angion has given Elicio four business days after the Angion Determination Notice to propose revisions to the terms of the Merger Agreement or make
another proposal, and has made its representatives reasonably available to negotiate in good faith with Elicio (to the extent Elicio desires to do so) with respect to such proposed revisions or other proposal, if any, and (3) after considering
the results of any such negotiations and giving effect to the proposals made by Elicio,
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if any, after consultation with outside legal counsel, the Angion Board
determines, in good faith, that the failure to make the Angion Board Adverse Recommendation Change in response to such Angion Change in Circumstance or terminate the Merger Agreement pursuant to the terms set forth therein would be inconsistent
with the fiduciary duties of the Angion Board to Angion’s stockholders under applicable law. The provisions of the Merger Agreement described in this paragraph also apply to any material change to the facts and circumstances relating to such
Angion Change in Circumstance and require a new Angion Determination Notice, except that the references to four business days will be deemed to be two business days.
“Angion Change in Circumstance” means a material development or
change in circumstances (other than any such event, development or change to the extent related to (A) any Acquisition Proposal, Acquisition Inquiry or the consequences thereof or (B) the fact, in and of itself, that Angion meets or exceeds
internal budgets, plans or forecasts of its revenues, earnings or other financial performance or results of operations) that affects the business, assets or operations of Angion that occurs or arises after the date of the Merger Agreement.
The Merger Agreement contemplates that promptly after the
Registration Statement is declared effective under the Securities Act, and in any event no later than three business days thereafter, Elicio will prepare, with the cooperation of Angion, and cause to be mailed to its stockholders an information
statement, which shall include a copy of this proxy statement/prospectus/information statement to solicit the approval by written consent from Elicio’s stockholders sufficient for the Required Elicio Stockholder Vote in lieu of a meeting
pursuant to Section 228 of the DGCL, for purposes of approving the Elicio Stockholder Matters.
Elicio agreed that: (i) the Elicio Board will recommend that the
Elicio stockholders vote to approve the Elicio Stockholder Matters and will use commercially reasonable efforts to solicit such approval certain officers, directors and stockholders of Elicio within the timeframe set forth above (the
recommendation of the Elicio Board that Elicio’s stockholders vote to adopt and approve the Elicio Stockholder Matters being referred to as the “Elicio Board Recommendation”); and (ii) the Elicio Board Recommendation will not be withdrawn or
modified (and the Elicio Board will not publicly propose to withdraw or modify the Elicio Board Recommendation) in a manner adverse to Angion, and no resolution by the Elicio Board or any committee thereof to withdraw or modify the Elicio Board
Recommendation in a manner adverse to Angion or to adopt, approve or recommend (or publicly propose to adopt, approve or recommend) any Acquisition Proposal will be adopted or proposed.
Under the DGCL, Angion stockholders are not entitled to appraisal
rights in connection with the Merger.
Elicio stockholders are entitled to statutory appraisal rights in
connection with the Merger under Section 262 of the DGCL. One of the conditions to Angion’s obligation to consummate the Merger is that the holders of no more than 5% of the shares of Elicio capital stock shall have exercised statutory
appraisal rights pursuant to Section 262 of the DGCL with respect to their shares of Elicio capital stock.
During the period from the date of the Merger Agreement and
continuing until the earlier of the termination of the Merger Agreement or the Effective Time, except (i) as set forth in Angion’s disclosure schedule, (ii) expressly permitted or required in accordance with the Merger Agreement, (iii) as
required by applicable law, or (iv) as may be consented to in writing by Elicio (not be unreasonably withheld, delayed or conditioned), each of Angion and its subsidiaries has agreed to (A) conduct its business and operations in the ordinary
course of business (which includes actions required to effect the Asset Dispositions or effect the winding down of Angion’s prior research and development activities) and in compliance in all material respects with all applicable laws and the
requirements of all of its material contracts and (B) continue to pay material outstanding accounts payable and other material current liabilities (including payroll) when due and payable, and will not:
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declare, accrue, set aside or pay any dividend or make any other distribution in respect of any shares of its capital stock
or repurchase, redeem or otherwise reacquire any shares of its capital stock or other securities (except repurchases of shares of Angion common stock from terminated employees, directors or consultants of Angion or in connection with
the payment of the exercise price and/or withholding taxes incurred upon the exercise, settlement or vesting of any award or purchase rights granted under Angion’s
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Second Amended and Restated 2015 Equity Incentive Plan, Angion’s 2021 Incentive
Plan and Angion’s 2021 Employee Stock Purchase Plan (collectively, Angion Plans) in accordance with the terms of such award in effect on the date of the Merger Agreement);
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sell, issue, grant, pledge or otherwise dispose of or encumber or authorize any of the foregoing with respect to: (A) any
capital stock or other security of Angion or any of its subsidiaries (except for Angion common stock issued upon the valid exercise of outstanding Angion options or Angion warrants, upon settlement of purchase rights under Angion’s 2021
Employee Stock Purchase Plan (Angion ESPP) or upon settlement of Angion restricted stock units); (B) any option, warrant or right to acquire any capital stock or any other security other than Angion stock options or restricted stock
unit awards granted to directors, employees and service providers or offerings providing eligible employees with purchase rights under the Angion ESPP, in either case, in the ordinary course of business which are included in the
calculation of the Angion Outstanding Shares; or (C) any instrument convertible into or exchangeable for any capital stock or other security of Angion or any of its subsidiaries;
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except as required to give effect to anything in contemplation of Closing, amend any of its or its subsidiaries’
organizational documents, or effect or be a party to any merger, consolidation, share exchange, business combination, recapitalization, reclassification of shares, stock split, reverse stock split or similar transaction except, for the
avoidance of doubt, the Contemplated Transactions;
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form any subsidiary or acquire any equity interest or other interest in any other entity or enter into a joint venture with
any other entity;
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(A) lend money to any person (except for the advancement of reasonable and customary expenses to employees, directors, and
consultants in the ordinary course of business), (B) incur or guarantee any indebtedness for borrowed money, (C) guarantee any debt securities of others, (D) other than the incurrence or payment of Transaction Expenses (as defined in “—Expenses”), make any capital expenditure in excess of $100,000 of the budgeted capital expenditure amount set forth in Angion’s operating budget delivered to Elicio concurrently with the execution of
the Merger Agreement (Angion Budget), or (E) forgive any loans to any persons, including Angion’s employees, officers, directors or affiliates;
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other than as required by applicable law or the terms of any Angion benefit plan as in effect on the date of the Merger
Agreement: (A) adopt, terminate, establish or enter into any Angion benefit plan; (B) cause or permit any Angion benefit plan to be amended; (C) pay any bonus or make any profit-sharing or similar payment to, or increase the amount of
the wages, salary, commissions, fringe benefits or bonus or other compensation or remuneration payable to, any of its directors, officers, consultants or employees other than increases in base salary and annual cash bonus opportunities
and payments made, in each case, in the ordinary course of business; (D) hire any officer or employee; or (E) increase the severance or change of control benefits offered to any current or new employees, directors or consultants;
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recognize any labor union or labor organization, except as otherwise required by applicable law and after prior written
consent of Elicio (not to be unreasonably withheld, conditioned or delayed);
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enter into any material transaction other than in the ordinary course of business;
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acquire any material asset or sell, lease or otherwise irrevocably dispose of any of its assets or properties, or grant any
encumbrance with respect to such assets or properties, except in the ordinary course of business;
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sell, assign, transfer, license, sublicense or otherwise dispose of any material Angion intellectual property (other than
pursuant to non-exclusive licenses in the ordinary course of business);
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make, change or revoke any material tax election, fail to pay any income or other material tax as such tax becomes due and
payable, file any amendment making any material change to any tax return, settle or compromise any income or other material tax liability or submit any voluntary disclosure application, enter into any tax allocation, sharing,
indemnification or other similar agreement or arrangement (other than customary commercial contracts entered into in the ordinary course of business the principal subject matter of which is not taxes), request or consent to any
extension or waiver of any limitation period with respect
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to any claim or assessment for any income or other material taxes (other than
pursuant to an extension of time to file any tax return granted in the ordinary course of business of not more than seven months), or adopt or change any material accounting method in respect of taxes;
|
•
|
enter into, materially amend or terminate any Angion material contract;
|
|
•
|
except as otherwise set forth in the Angion Budget and the incurrence or payment of any Transaction Expenses (as defined in
“—Expenses”), make any expenditures, incur any liabilities or discharge or satisfy any liabilities, in each case, in amounts that exceed the aggregate amount of the Angion Budget by $100,000;
|
|
•
|
other than as required by law or GAAP, take any action to change accounting policies or procedures;
|
|
•
|
initiate or settle any legal proceeding; or other claim or dispute involving or against Angion or any of its subsidiaries;
|
|
•
|
enter into or amend a material contract that would reasonably be expected to prevent or materially impede, interfere with,
hinder or delay the consummation of the Contemplated Transactions;
|
|
•
|
after the Angion Net Cash calculation is finalized and agreed to by the parties, incur any liabilities in excess of $25,000
in the aggregate or otherwise take any action other than, in each case, in the ordinary course of business or in connection with the Contemplated Transactions; or
|
|
•
|
agree, resolve or commit to do any of the foregoing.
|
During the period from the date of the Merger Agreement and
continuing until the earlier of the termination of the Merger Agreement or the Effective Time, except (i) as set forth in Elicio’s disclosure schedule, (ii) expressly permitted or required in accordance with the Merger Agreement, (iii) as
required by applicable law, or (iv) as may be consented to in writing by Angion (not be unreasonably withheld, delayed or conditioned), each of Elicio and its subsidiaries has agreed to (A) conduct its business and operations in the ordinary
course of business and in compliance in all material respects with all applicable laws and the requirements of all of its material contracts and (B) continue to pay material outstanding accounts payable and other material current liabilities
(including payroll) when due and payable, and will not, and will not cause or permit any of its subsidiaries to:
|
•
|
declare, accrue, set aside or pay any dividend or make any other distribution in respect of any shares of its capital stock
or repurchase, redeem or otherwise reacquire any shares of its capital stock or other securities (except repurchases of shares of Elicio common stock from terminated employees, directors or consultants of Angion or in connection with
the payment of the exercise price and/or withholding taxes incurred upon the exercise, settlement or vesting of any award or purchase rights granted under the Elicio Plans in accordance with the terms of such award in effect on the date
of the Merger Agreement);
|
|
•
|
sell, issue, grant, pledge or otherwise dispose of or encumber or authorize any of the foregoing with respect to: (A) any
capital stock or other security of Elicio or any of its subsidiaries (except for shares of Elicio common stock issued upon the valid exercise of outstanding Elicio stock options or Elicio warrants or the valid settlement of outstanding
Elicio restricted stock units); (B) any option, warrant or right to acquire any capital stock or any other security other than Elicio stock options or restricted stock unit awards granted to directors, employees and service providers in
the ordinary course of business which are included in the calculation of the Elicio Outstanding Shares; or (C) any instrument convertible into or exchangeable for any capital stock or other security of Elicio or any of its subsidiaries;
|
|
•
|
except as required to give effect to anything in contemplation of the Closing, amend any of its or its subsidiaries’
organizational documents, or effect or be a party to any merger, consolidation, share exchange, business combination, recapitalization, reclassification of shares, stock split, reverse stock split or similar transaction except, for the
avoidance of doubt, in connection with the Contemplated Transactions;
|
|
•
|
form a subsidiary or acquire any equity interest or other interest in any other entity or enter into a joint venture with any
other entity;
|
|
•
|
(A) lend money to any person (except for the advancement of reasonable and customary expenses to employees and directors in
the ordinary course of business), (B) incur or guarantee any indebtedness for borrowed money, (C) guarantee any debt securities of others, (D) other than the incurrence or payment of Transaction Expenses (as defined in “—Expenses”), make any capital expenditures in excess of
|
150
$100,000 of the budgeted capital expenditure amounts set forth in Elicio’s
operating budget delivered to Angion on the date of the Merger Agreement (Elicio Budget), or (E) forgive any loans to any persons, including Elicio’s employees, officers, directors or affiliates;
|
•
|
other than as required by applicable law or the terms of any Elicio benefit plan as in effect on the date of the Merger
Agreement: (A) adopt, terminate, establish or enter into any Elicio benefit plan; (B) cause or permit any Elicio benefit plan to be amended; (C) pay any bonus or make any profit-sharing or similar payment to, or increase the amount of
the wages, salary, commissions, fringe benefits or bonus or other compensation or remuneration payable to, any of its directors, officers, consultants or employees other than increases in base salary and annual cash bonus opportunities
and payments made, in each case, in the ordinary course of business; (D) increase the severance or change of control benefits offered to any current or new employees, directors or consultants; or (E) terminate or give notice to any
officer other than for cause;
|
|
•
|
recognize any labor union or labor organization, except as otherwise required by applicable law and after prior written
consent of Angion (not be unreasonably withheld, conditioned or delayed;
|
|
•
|
enter into any material transaction other than in the ordinary course of business;
|
|
•
|
acquire any material asset or sell, lease or otherwise irrevocably dispose of any of its assets or properties, or grant any
encumbrance with respect to such assets or properties, except in the ordinary course of business;
|
|
•
|
sell, assign, transfer, license, sublicense or otherwise dispose of any Elicio intellectual property (other than pursuant to
non-exclusive licenses in the ordinary course of business);
|
|
•
|
make, change or revoke any material tax election, fail to pay any income or other material tax as such tax becomes due and
payable, file any amendment making any material change to any tax return, settle or compromise any income or other material tax liability or submit any voluntary disclosure application, enter into any tax allocation, sharing,
indemnification or other similar agreement or arrangement (other than customary commercial contracts entered into in the ordinary course of business the principal subject matter of which is not taxes), request or consent to any
extension or waiver of any limitation period with respect to any claim or assessment for any income or other material taxes (other than pursuant to an extension of time to file any tax return granted in the ordinary course of business
of not more than seven months), or adopt or change any material accounting method in respect of taxes;
|
|
•
|
enter into, materially amend or terminate any Elicio material contract (other than statements of work entered into or amended
in the ordinary course of business);
|
|
•
|
except as otherwise set forth in the Elicio Budget and the incurrence or payment of any Transaction Expenses (as defined in
“—Expenses”), make any expenditures, incur any liabilities or discharge or satisfy any liabilities, in each case, in amounts that exceed the aggregate amount of the Elicio Budget by $150,000;
|
|
•
|
other than as required by law or GAAP, take any action to change accounting policies or procedures;
|
|
•
|
initiate or settle any legal proceeding or other claim or dispute involving or against Elicio or any of its subsidiaries;
|
|
•
|
enter into or amend a contract that would reasonably be expected to prevent or materially impede, interfere with, hinder or
delay the consummation of the Contemplated Transactions; or
|
|
•
|
agree, resolve or commit to do any of the foregoing.
|
The Merger Agreement may be terminated prior to the Effective Time
(whether before or after the required stockholder approvals to consummate the Merger have been obtained, unless otherwise specified below):
|
(a)
|
by mutual written consent of Angion and Elicio;
|
|
(b)
|
by either Angion or Elicio if the Contemplated Transactions have not been consummated by October 17, 2023 (subject to
possible extension as provided in this paragraph, the End Date); provided, however, that the right to terminate the Merger Agreement under this paragraph will not be available to a party if such
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151
party’s (or, in the case of Angion, Merger Sub’s) action or failure to act has
been a principal cause of the failure of the Contemplated Transactions to occur on or before the End Date and such action or failure to act constitutes a breach of the Merger Agreement; provided, further, however, that, in the event that a
request for additional information has been made by any governmental body or in the event that the SEC has not declared the Registration Statement effective under the Securities Act by the date which is 30 calendar days prior to the End Date,
then Angion will be entitled to extend the End Date for an additional 60 calendar days by written notice to Elicio;
|
(c)
|
by either Angion or Elicio if a court of competent jurisdiction or other governmental body has issued a final and
non-appealable order, decree or ruling, or has taken any other action, having the effect of permanently restraining, enjoining or otherwise prohibiting the Contemplated Transactions;
|
|
(d)
|
by Angion if the Elicio Stockholder Written Consent has not been obtained within three business days of the date of the
Registration Statement becoming effective in accordance with the provisions of the Securities Act; provided, however, that once the Elicio Stockholder Written Consent has been obtained, Angion may not terminate the Merger Agreement
pursuant to this paragraph;
|
|
(e)
|
by either Angion or Elicio if (i) the Angion special meeting (including any adjournments and postponements thereof) was held
and completed and (ii) the Angion Stockholder Matters were not approved at such Angion special meeting by the Required Angion Stockholder Vote; provided, however, that the right to terminate the Merger Agreement pursuant to this
paragraph will not be available to Angion where the failure to obtain the Required Angion Stockholder Vote was caused by the action or failure to act of Angion and such action or failure to act constitutes a material breach by Angion of
the Merger Agreement;
|
|
(f)
|
by Elicio (at any time prior to the approval of the Angion Stockholder Matters by the Required Angion Stockholder Vote) if an
Angion Triggering Event (as defined below) has occurred;
|
|
(g)
|
by Angion (at any time prior to the Required Elicio Stockholder Vote being obtained) if an Elicio Triggering Event (as
defined below) has occurred;
|
|
(h)
|
by Elicio, upon a breach of any representation, warranty, covenant or agreement set forth in the Merger Agreement by Angion
or Merger Sub or if any representation or warranty of Angion or Merger Sub has become inaccurate, in either case, such that certain closing conditions set forth in the Merger Agreement would not be satisfied as of the time of such
breach or as of the time such representation or warranty has become inaccurate; provided that Elicio is not then in material breach of any representation, warranty, covenant or agreement under the Merger Agreement; provided, further,
that if such inaccuracy in Angion’s or Merger Sub’s representations and warranties or breach by Angion or Merger Sub is curable by the End Date by Angion or Merger Sub, then the Merger Agreement will not terminate pursuant to this
paragraph as a result of such particular breach or inaccuracy until the earlier of (i) the End Date and (ii) the expiration of a 30 calendar day period commencing upon delivery of written notice from Elicio to Angion or Merger Sub of
such breach or inaccuracy and its intention to terminate pursuant to this paragraph (it being understood that the Merger Agreement will not terminate pursuant to this paragraph as a result of such particular breach or inaccuracy if such
breach by Angion or Merger Sub is cured prior to such termination becoming effective);
|
|
(i)
|
by Angion, upon a breach of any representation, warranty, covenant or agreement set forth in the Merger Agreement by Elicio
or if any representation or warranty of Elicio has become inaccurate, in either case, such that certain closing conditions set forth in the Merger Agreement would not be satisfied as of the time of such breach or as of the time such
representation or warranty has become inaccurate; provided that Angion is not then in material breach of any representation, warranty, covenant or agreement under the Merger Agreement; provided, further, that if such inaccuracy in
Elicio’s representations and warranties or breach by Elicio is curable by End Date by Elicio then the Merger Agreement will not terminate pursuant to this paragraph as a result of such particular breach or inaccuracy until the earlier
of (i) the End Date and (ii) the expiration of a 30 calendar day period commencing upon delivery of written notice from Angion to Elicio of such breach or inaccuracy and its intention to terminate pursuant to this paragraph (it being
understood that the Merger Agreement will not terminate pursuant to this paragraph as a result of such particular breach or inaccuracy if such breach by Elicio is cured prior to such termination becoming effective);
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152
|
(j)
|
by Angion, at any time prior to the approval of the Angion Stockholder Matters by the Required Angion Stockholder Vote, if
(i) Angion has received a Superior Offer, (ii) Angion has complied with its obligations under the non-solicitation and Angion Board Adverse Recommendation Change provisions of the Merger Agreement, (iii) the Angion Board has determined
in good faith, after consultation with its outside legal counsel, that the failure to terminate the Merger Agreement would be reasonably likely to be inconsistent with its fiduciary duties under applicable law, (iv) Angion concurrently
terminates the Merger Agreement and enters into a definitive agreement with respect to such Superior Offer and (v) Angion concurrently pays to Elicio the applicable termination fee;
|
|
(k)
|
by Elicio if, on the End Date, Angion’s Net Cash has fallen below $25 million, such that the Net Cash Condition is not
satisfied as of the End Date; or
|
|
(l)
|
by Angion, if Elicio has not provided to Angion (i) the unaudited consolidated financial statements of Elicio and its
consolidated subsidiaries for the period ended September 30, 2022 no later than February 1, 2023 or (ii) the audited consolidated financial statements for the fiscal year ended 2022 no later than March 15, 2023, in each case in
accordance with the Merger Agreement.
|
The party desiring to terminate the Merger Agreement will give the
other party written notice of such termination, specifying the provisions of the Merger Agreement pursuant to which such termination is made and the basis therefor described in reasonable detail.
“Elicio Triggering Event” will be deemed to have occurred if: (a)
the Elicio Board has made an Elicio Board Adverse Recommendation Change; (b) the Elicio Board or any committee thereof has publicly approved, endorsed or recommended any Acquisition Proposal; or (c) Elicio has entered into any letter of intent
or similar document or any contract relating to any Acquisition Proposal.
“Angion Triggering Event” will be deemed to have occurred if: (a)
Angion has failed to include in the proxy statement/prospectus/information statement the Angion Board Recommendation or has made an Angion Board Adverse Recommendation Change; (b) the Angion Board or any committee thereof has approved, endorsed
or recommended any Acquisition Proposal; (c) Angion has entered into any letter of intent or similar document or any contract relating to any Acquisition Proposal (other than a confidentiality agreement permitted pursuant to the Merger
Agreement); or (d) Angion or any director or officer of Angion has willfully and intentionally breached the provisions set forth in the non-solicitation or Angion stockholders’ meeting provisions of the Merger Agreement.
Angion must pay Elicio a nonrefundable termination fee of
$1 million if (A) the Merger Agreement is terminated by Elicio pursuant to clause (b), (e) or (h) above, (B) an Acquisition Proposal with respect to Angion has been publicly announced, disclosed or otherwise communicated to Angion or the Angion
Board at any time after the date of the Merger Agreement but prior to the termination of the Merger Agreement (which has not been withdrawn) and (C) within 12 months after the date of such termination, Angion enters into a definitive agreement
with respect to a subsequent transaction or consummates a subsequent transaction in respect of such Acquisition Proposal. Angion must pay Elicio a nonrefundable termination fee of $2 million if the Merger Agreement is terminated by Elicio
pursuant to clause (f) above (or at the time the Merger Agreement is terminated, Elicio has the right to terminate the Merger Agreement pursuant to clause (f) above) or the Merger Agreement is terminated by Angion pursuant to clause (j) above.
Elicio must pay Angion a nonrefundable termination fee of
$1 million if (i) (A) the Merger Agreement is terminated by Angion pursuant to clause (b), (d) or (i) above, (B) an Acquisition Proposal with respect to Elicio has been publicly announced, disclosed or otherwise communicated to Elicio or the
Elicio Board at any time after the date of the Merger Agreement but prior to the termination of the Merger Agreement (which has not been withdrawn) and (C) within 12 months after the date of such termination, Elicio enters into a definitive
agreement with respect to a subsequent transaction or consummates a subsequent transaction in respect of such Acquisition Proposal; or (ii) the Merger Agreement is terminated by Angion pursuant to clause (g) above (or at the time the Merger
Agreement is terminated, Angion has the right to terminate the Merger Agreement pursuant to clause (g) above).
If the Merger Agreement is terminated by Elicio pursuant to clause
(e) or (k) above or in the event of the failure of Elicio to consummate the transactions to be contemplated at the Closing solely as a result of an Angion Material Adverse Effect as set forth in the Merger Agreement (provided, that at such time
all other conditions precedent to Angion’s obligation to close set forth in the Merger Agreement have been satisfied by Elicio, are capable of being satisfied by Elicio or have been waived by Angion), then Angion will reimburse Elicio for all
reasonable
153
out-of-pocket fees and expenses incurred by Elicio in connection with the Merger
Agreement and the Contemplated Transactions, up to a maximum of $500,000, by wire transfer of same-day funds within ten business days following the date on which Elicio submits to Angion true and correct copies of reasonable documentation
supporting such expenses; provided, however, that such expenses shall not include any amounts for financial advisors to Elicio except for reasonably documented out-of-pocket expenses otherwise reimbursable by Elicio to such financial advisors
pursuant to the terms of Elicio’s engagement letter or similar arrangement with such financial advisors. To the extent any such expenses are paid, such amounts will be credited against any termination fee that becomes payable by Angion to
Elicio thereafter.
If the Merger Agreement is terminated by Angion pursuant to clause
(i) or in the event of the failure of Angion to consummate the transactions to be consummated to the Closing solely as a result of an Elicio Material Adverse Effect as set forth in the Merger Agreement (provided, that at such time all other
conditions precedent to Elicio’s obligation to close set forth in the Merger Agreement have been satisfied by Angion, are capable of being satisfied by Angion or have been waived by Elicio), then Elicio will reimburse Angion for all reasonable
out-of-pocket fees and expenses incurred by Angion in connection with the Merger Agreement and the Contemplated Transactions, up to a maximum of $500,000, by wire transfer of same-day funds within ten business days following the date on which
Angion submits to Elicio true and correct copies of reasonable documentation supporting such expenses; provided, however, that such expenses shall not include any amounts for financial advisors to Angion except for reasonably documented
out-of-pocket expenses otherwise reimbursable by Angion to such financial advisors pursuant to the terms of Angion’s engagement letter or similar arrangement with such financial advisors. To the extent any such expenses are paid, such amounts
will be credited against any termination fee that becomes payable by Elicio to Angion thereafter.
Director Indemnification and Insurance
The Merger Agreement provides that, subject to certain limitations
as set forth in the Merger Agreement, from the Effective Time through the sixth anniversary of the date on which the Effective Time occurs, Angion and the surviving company will indemnify each person who is, has been at any time prior to the
date of the Merger Agreement, or who becomes prior to the Effective Time, a director, officer, fiduciary or agent of Angion or Elicio or their respective subsidiaries.
The Merger Agreement also provides that the provisions relating to
the indemnification, advancement of expenses and exculpation of present and former directors and officers of Angion or any of its subsidiaries set forth in the organizational documents of Angion or any of its subsidiaries will not be amended,
modified or repealed for a period of six years from the Effective Time in any manner that would adversely affect the rights of individuals who, at or prior to the Effective Time, were officers or directors of Angion or any of its subsidiaries,
unless required by applicable law. After Closing, the organizational documents of the surviving corporation will contain provisions at least as favorable as the provisions relating to the indemnification, advancement of expenses and exculpation
of present and former directors and officers presently set forth in Angion’s organizational documents as of the date of the Merger Agreement. Angion has agreed to purchase a six year “tail policy” with an effective date as of the Closing Date
for the non-cancellable extension of Angion’s existing directors’ and officers’ liability insurance policies and Angion’s existing fiduciary liability insurance policies (if any).
Listing
Angion common stock currently is listed on The Nasdaq Global
Market under the symbol “ANGN.” Angion has agreed to use commercially reasonable efforts (i) to maintain its existing listing on Nasdaq until the Closing Date and obtain approval of the listing of the combined company on Nasdaq, (ii) without
derogating from the requirements of the foregoing clause (i) and to the extent required by the rules and regulations of Nasdaq, to prepare and submit to Nasdaq a notification form for the listing of the shares of Angion common stock to be
issued in connection with the Contemplated Transactions, and to cause such shares to be approved for listing (subject to official notice of issuance), (iii) to effect the Reverse Stock Split and (iv) to the extent required by Nasdaq Marketplace
Rule 5110, to file an initial Nasdaq Listing Application for the Angion common stock on Nasdaq and to cause such listing application to be conditionally approved prior to the Effective Time.
The parties will use commercially reasonable efforts to coordinate
with respect to compliance with Nasdaq rules and regulations. Elicio will cooperate with Angion as reasonably requested by Angion with respect to the Nasdaq
154
Listing Application and promptly furnish to Angion all information concerning
Elicio and its stockholders that may be required or reasonably requested in connection with any action contemplated by the foregoing paragraph.
Expenses
Pursuant to the Merger Agreement, all the Transaction Expenses (as
defined below) will be paid by the party incurring such expense, whether or not the Merger is consummated, except in connection with a disagreement regarding Angion Net Cash, the fees and expenses of the Accounting Firm will be allocated
between Elicio and Angion in the proportion that the unsuccessfully disputed amount of Angion Net Cash bears to the total disputed amount of Angion Net Cash.
“Transaction Expenses” means, with respect to each party, all fees
and expenses incurred by such party at or prior to the Effective Time in connection with the Contemplated Transactions and the Merger Agreement, including (a) any fees and expenses of legal counsel and accountants and the maximum amount of fees
and expenses payable to financial advisors, investment bankers, brokers, consultants, and other advisors of such party in connection with the negotiation, preparation and execution of the Merger Agreement and the consummation of the
Contemplated Transactions (including in connection with any stockholder litigation relating to the Merger Agreement or any of the Contemplated Transactions), including finders’ fees; (b) only with respect to Angion, fees paid to the SEC in
connection with filing the Registration Statement, the proxy statement/prospectus/information statement, and any amendments and supplements hereto or thereto, with the SEC; (c) only with respect to Angion, any fees and expenses in connection
with the printing, mailing and distribution of the Registration Statement and any amendments and supplements hereto; (d) 50% of the fees and expenses payable to Nasdaq in connection with the Nasdaq Listing Application; (e) any bonus, severance,
change-in-control or retention payments or similar payment obligations (including payments with “single-trigger” provisions triggered at and as of the Closing) that become due or payable to any director, officer, employee or consultant of
Angion or any of its subsidiaries in connection with the consummation of the Contemplated Transactions; (f) only with respect to Angion, any fees and expenses incurred in connection with the directors’ and officers’ tail policy described above;
(g) only with respect to Angion, any potential cash payments payable pursuant to a “fundamental transaction” provision of any Angion warrants; (h) only with respect to Angion, any notice payments, change-of-control payments, fines or other
payments to be made by Parent in connection with terminating any existing contract to which Angion is a party or winding down any of Angion’s clinical trial obligations; and (i) only with respect to Angion, any wind-down costs of Angion
associated with discontinued lab, research and development and related operations.
The Merger Agreement may be amended by the parties at any time
with the written approval of the respective boards of directors of Elicio, Merger Sub and Angion, except that after the Merger Agreement has been adopted and approved by a party’s stockholders, no amendment which by law requires further
approval by the stockholders of that party will be made without such further stockholder approval.
155
Concurrently with the execution of the Merger Agreement, executive
officers, directors and stockholders of Angion entered into the Angion Support Agreements in favor of Elicio relating to the Merger. The Angion Support Agreements provide, among other things, that such officers, directors and stockholders will
vote all of their shares of Angion common stock: (i) in favor of adopting the Merger Agreement and approving the Merger, the Required Angion Closing Stockholder Matters, and the other Contemplated Transactions, (ii) against any proposal made in
opposition to, or in competition with, the Merger Agreement or the Merger and (iii) against any acquisition proposal involving a third party.
Concurrently with the execution of the Merger Agreement, executive
officers, directors and stockholders of Elicio entered the Elicio Support Agreements in favor of Angion relating to the Merger. The Elicio Support Agreements provide, among other things, that such executive officers, directors and stockholders
vote all of their shares of Elicio capital stock: (i) in favor of adopting the Merger Agreement and approving the Merger, the Elicio Stockholder Matters, and the other Contemplated Transactions, (ii) against any proposal made in opposition to,
or in competition with, the Merger Agreement or the Merger and (iii) against any acquisition proposal involving a third party.
Concurrently with the execution of the Merger Agreement,
(i) certain executive officers, directors, and stockholders of Elicio and (ii) certain directors of Angion, entered into the Lock-Up Agreements, pursuant to which such persons accepted certain restrictions on transfers of the shares of Angion
common stock held by such persons for the 180-day period following the Effective Time.
In connection with execution of the Merger Agreement, Angion made
a bridge loan to Elicio pursuant to a Note Purchase Agreement (the Note Purchase Agreement) and Promissory Notes (the Notes) up to an aggregate principal amount of $12.5 million, issued with a 20% original issue discount, with an initial
closing held substantially concurrently with the execution of the Merger Agreement for a principal amount of $6.25 million on account of a $5.0 million loan and an additional closing for a principal amount of $6.25 million on account of a
$5.0 million loan upon delivery by Elicio to Angion of Elicio’s audited financial statements for the year ended December 31, 2022. If the Merger is consummated or Elicio terminates the Merger Agreement for Angion’s breach of the Merger
Agreement under certain circumstances, the Notes will bear simple interest at 1.0% annually from and after the date of the Merger Agreement based on a principal amount equal to the amount actually advanced by Angion. If Angion terminates the
Merger Agreement for Elicio’s breach of the Merger Agreement under circumstances, the outstanding principal balance of the Notes will be paid back by Elicio within ten business days of such termination. Upon the consummation of the Contemplated
Transactions, all obligations owed by Elicio under the Notes will be automatically forgiven, and the amount actually advanced by Angion and any accrued and unpaid interest thereon outstanding at such time will be credited toward the Angion Net
Cash, as provided in the Merger Agreement.
156
The following table sets forth information regarding Angion’s
executive officers and directors as of March 15, 2023:
|
Name
|
| |
Age
|
| |
Position(s)
|
|
Executive Officers and Employee
Directors:
|
| |
|
| |
|
|
Jay R. Venkatesan, M.D.
|
| |
51
|
| |
President, Chief Executive Officer, Chairman and Director
|
|
Jennifer J. Rhodes, J.D.
|
| |
53
|
| |
Executive Vice President, Chief Business Officer, General Counsel, Chief
Compliance Officer and Corporate Secretary
|
|
Gregory S. Curhan
|
| |
61
|
| |
Chief Financial Officer
|
|
Non-Employee Directors:
|
| |
|
| |
|
|
Victor F. Ganzi, J.D.
|
| |
76
|
| |
Director, Lead Independent Director
|
|
Itzhak D. Goldberg, M.D.
|
| |
74
|
| |
Director and Chairman Emeritus
|
|
Allen R. Nissenson, M.D.
|
| |
76
|
| |
Director
|
|
Gilbert S. Omenn, M.D., Ph.D.
|
| |
82
|
| |
Director
|
|
Karen J. Wilson
|
| |
60
|
| |
Director
|
Each of Mr. Ganzi, Dr. Nissenson, Dr. Omenn and Ms. Wilson is a
member of each of the Audit Committee, the Compensation Committee and the Nominating and Corporate Governance Committee. Ms. Wilson is the Chairperson of the Audit Committee, Dr. Nissenson is the Chairperson of the Compensation Committee, and
Dr. Omenn is the chairperson of the Corporate Governance Committee.
Jay R. Venkatesan, M.D.,
President, Chief Executive Officer and Chairman. Dr. Venkatesan was appointed Chairman of the Board in January 2022, and he has been Angion’s President and Chief Executive Officer and
director since May 2018. Dr. Venkatesan has served as a Managing Partner of Alpine BioVentures, an investment firm since July 2015. From July 2015 to August 2018, Dr. Venkatesan served as President of Alpine Immune Sciences, an immunotherapy
company that he co-founded as a Managing Partner of Alpine BioVentures, and also served as its Chief Executive Officer from July 2015 to June 2016. Additionally, as Managing Partner of Alpine BioVentures, from January 2014 to August 2014, Dr.
Venkatesan served as Founder and Chief Executive Officer of Alpine BioSciences, a biotechnology company, which was acquired by Cascadian Therapeutics, where he then served as Executive Vice President and General Manager from August 2014 to
May 2015 (subsequently acquired by Seagen, Inc.). Since January 2008, Dr. Venkatesan has served as the founder and managing member of Ayer Capital, a global healthcare fund. Prior to that, he served as a director at Brookside Capital, part of
Bain Capital, where he co-managed healthcare investments. He was also a consultant at McKinsey & Co., a consulting firm, and a venture investor with Patricof & Co. Ventures (now Apax Partners), an investment firm. Dr. Venkatesan has
served on the board, of Alpine Immune Sciences, Inc. (Nasdaq: ALPN) since June 2015. Dr. Venkatesan previously served on the board of Exicure Inc. (Nasdaq: XCUR) from March 2014 to December 2020 and Iovance Biotherapeutics Inc. (Nasdaq: IOVA)
from September 2013 to March 2018. He has an M.D. from the University of Pennsylvania School of Medicine, an M.B.A. from The Wharton School of the University of Pennsylvania, and a B.A. from Williams College. Angion believes that Dr.
Venkatesan’s leadership experience and investment experience in the biopharmaceutical industry qualify him to serve as a member of Angion’s Board.
Jennifer J. Rhodes, J.D. Ms. Rhodes was appointed Executive Vice President and Chief Business Officer in March 2022 and she has served as, General Counsel, Chief Compliance Officer and Corporate Secretary since
January 2020. From February 2019 to December 2022, Ms. Rhodes also served as a director of Legal Aid at Work, a non-profit legal services organization. Ms. Rhodes previously served as General Counsel and Corporate Secretary at Adamas
Pharmaceuticals, Inc., a public pharmaceutical company, from April 2016 until January 2020, during which time she also served as Chief Compliance Officer since August 2016 and Chief Business Officer since January 2017. Prior to that,
Ms. Rhodes served as General Counsel at Medivation, Inc., a biopharmaceutical company, from June 2012 to September 2015, where she was responsible for Medivation’s legal matters, and also served as Corporate Secretary from April 2013 to
September 2015 and as Chief Compliance Officer from July 2012 to October 2014. From May 2006 to June 2012, Ms. Rhodes was an Assistant General Counsel at Pfizer Inc., a
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biopharmaceutical company, where she supported the U.S. Primary Care Business and
its Primary Care Medicines Development Group and served as a global product lead for Pfizer Inc.’s primary care medicines. Prior to joining Pfizer Inc., she was an associate in the regulatory law and international trade practice areas at Weil,
Gotshal & Manges, LLP from October 2000 to April 2006. Ms. Rhodes has a J.D. from Wake Forest University School of Law and a B.A. in Economics from Newcomb College of Tulane University.
Gregory S. Curhan. Mr. Curhan has served as Angion’s Chief Financial Officer since June 2020 through his capacity as a partner at FLG Partners, LLC (FLG Partners), a Silicon Valley chief financial officer
services firm. Prior to joining FLG Partners, LLC, Mr. Curhan was Chief Financial Officer and Senior Vice President Corporate Development of Providence Medical Technology, a venture-backed medical device manufacturer, December 2016 until
January 2020. Prior to that, Mr. Curhan was a Business Development Officer at Brighton Jones, a financial planning company, from December 2012 to December 2016. Mr. Curhan has a B.A. in Economics from Dartmouth College.
Non-Employee Directors
Victor F. Ganzi. Mr. Ganzi has been a member of Angion’s Board since April 2018, and lead independent director since February 2021. He has served as Non-Executive Chairman of the board of directors of Willis
Towers Watson (Nasdaq: WTW), a global advisory, broking, and solutions company since January 2019 and as a director since January 2016. Previously, he served as a director of Towers Watson beginning on January 1, 2010, as Chairman of Towers
Watson’s Audit Committee, and a member of its Nominating and Governance Committee. Mr. Ganzi is presently a consultant and corporate director, serving on the public company board of Aveanna Healthcare Holdings Inc., a provider of pediatric
and adult home healthcare and hospice care since 2016, and serving on the boards of numerous private and not-for-profit organizations, including PGA Tour, Inc., the Partnership to End Addiction, the Whitney Museum of American Art and the
Madison Square Boys and Girls Club. Mr. Ganzi was the President and Chief Executive Officer of The Hearst Corporation, a private diversified communications company, from 2002 to 2008. He served as Hearst’s Executive Vice President from 1997
to 2002 and as its Chief Operating Officer from 1998 to 2002. Prior to joining Hearst in 1990, Mr. Ganzi was the managing partner at the international law firm of Rogers & Wells (now part of Clifford Chance). Mr. Ganzi previously served
as a director of Gentiva Health Services, Inc., Wyeth and Hearst-Argyle Television, Inc. Mr. Ganzi has a B.S. in Accounting summa cum laude, from Fordham University, a J.D. from Harvard Law School and an L.L.M. in Taxation from New York
University. Angion believes that Mr. Ganzi’s years of experience serving on boards and legal expertise qualify him to serve as a member of Angion’s Board.
Itzhak D. Goldberg, M.D., Dr. Goldberg was appointed Chairman Emeritus in January 2022, after having been a director and Chairman of the Board since March 2018. Dr. Goldberg also served as Executive Chairman and Chief
Scientific Officer between March 2018 and March 2022, after serving as Angion’s Chairman, President, Chief Executive Officer and Scientific Director since Angion’s founding in April 1998. Dr. Goldberg was formerly a faculty member at Harvard
Medical School, Radiation Oncologist-in-Chief for the North Shore-LIJ (Northwell) Health System, and Professor at the Albert Einstein College of Medicine. He is a Fellow of the American College of Radiology. Dr. Goldberg has an M.D. from
Albert Einstein College of Medicine, was a postdoctoral research fellow at Harvard Medical School and was subsequently trained as a radiation oncologist at the Harvard Joint Center for Radiation Therapy. Angion believes that Dr. Goldberg’s
extensive experience in the biopharmaceutical industry qualifies him to serve as a member of Angion’s Board.
Allen R. Nissenson, M.D. Dr. Nissenson has been a member of Angion’s Board since January 2020. He completed serving as the Emeritus Chief Medical Officer of DaVita Kidney Care in January 2022, where he has served
since January 2020 and where he previously served as Chief Medical Officer from August 2008 to January 2020. He is currently an Emeritus Professor of Medicine at the David Geffen School of Medicine at UCLA, where he has served since August
2008 and where he previously served as Director of the Dialysis Program from July 1977 to August 2008 and Associate Dean from July 2005 to August 2008. Dr. Nissenson is also currently on the board of directors of Rockwell Medical Inc., a
public biopharmaceutical company, which he joined in June 2020 and Diality, a private technology development company. Dr. Nissenson is a past chair of Kidney Care Partners and past co-chair of the Kidney Care Quality Alliance. He is a former
president of the Renal Physicians Association (RPA) and current member of the Government Affairs Committee. Dr. Nissenson also previously served as president of the Southern California End-Stage Renal Disease Network, as well as chair of the
Medical Review Board. He served as a Robert Wood Johnson Health Policy Fellow of the National Academy of Medicine from 1994 to 1995 and worked in the office of the late Senator Paul Wellstone. Dr. Nissenson has an M.D. from Northwestern
University Medical School
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and is the recipient of various awards, including the President’s Award of the
National Kidney Foundation, the Lifetime Achievement Award in Hemodialysis, the American Association of Kidney Patients’ (AAKP) Medal of Excellence Award and, in 2017, the RPA Distinguished Nephrology Service Award. Angion believes that
Dr. Nissenson’s years of experience in the healthcare industry qualify him to serve as a member of Angion’s Board.
Gilbert S. Omenn, M.D.,
Ph.D. Dr. Omenn has been a member of Angion’s Board since January 2020. Since 1997, Dr. Omenn has been a faculty member at the University of Michigan, where he is currently the Harold
T. Shapiro Distinguished University Professor of Computational Medicine & Bioinformatics, Internal Medicine, Human Genetics, and Public Health. Earlier, he was the dean of the School of Public Health and Community Medicine and professor
of medicine at the University of Washington. Dr. Omenn served as Executive Vice President for Medical Affairs of the University of Michigan and as Chief Executive Officer of the University of Michigan Health System from 1997 to 2002. From
1977 to 1981 he was associate director of the White House Office of Science & Technology Policy and then the Office of Management & Budget. Dr. Omenn is a member of the National Academy of Medicine and the American Academy of Arts and
Sciences. He chaired the Presidential/Congressional Commission on Risk Assessment and Risk Management, the NAS/NAE/IOM Committee on Science, Engineering, and Public Policy, and the Advisory Committee for the Agency for Toxic Substances and
Disease Registry. He served on the National Commission on the Environment, the NIH Scientific Management Review Board, and the CDC Director’s Advisory Committee. He is a past president of the American Association for the Advancement of
Science. Since 2014, Dr. Omenn has served as a director of Galectin Therapeutics Inc., a biotechnology company (Nasdaq: GALT), and since 2020 as a director of Amesite Inc, an AI-based educational technology company (Nasdaq: AMST). Dr. Omenn
previously served as a director of Amgen, Inc. for 27 years and Rohm & Haas Company for 22 years. Dr. Omenn was a director of Esperion Therapeutics (Nasdaq: ESPR) from August 2014 to May 2018. He is a director of the Hastings Center for
Bioethics and the Center for Public Integrity. Dr. Omenn has a B.A. summa cum laude from Princeton University, M.D. magna cum laude from Harvard Medical School and Ph.D. in genetics from the University of Washington. Angion believes that Dr.
Omenn’s years of experience in the healthcare industry qualify him to serve as a member of Angion’s Board.
Karen J. Wilson. Ms. Wilson has been a member of Angion’s Board since April 2020. Ms. Wilson is also currently a member of the boards of directors of Connect Biopharma, and LAVA Therapeutics. Ms. Wilson also
served as a member of the board of directors of Vaxart, Inc. between August 2020 to August 2022. Ms. Wilson previously served as Senior Vice President of Finance at Jazz Pharmaceuticals plc, a biopharmaceutical company, until September 2020
after serving as Principal Accounting Officer and Vice President of Finance. Prior to joining the Jazz Pharmaceuticals organization in February 2011, she served as Principal Accounting Officer and Vice President of Finance at PDL BioPharma,
Inc., a life sciences company. She also previously served as a Principal at the consulting firm of Wilson Crisler LLC, Chief Financial Officer of ViroLogic, Inc., a biosciences company, Chief Financial Officer and Vice President of Operations
for Novare Surgical Systems, Inc., a medical device manufacturer, and as a consultant and auditor for Deloitte & Touche LLP, a professional services firm. Ms. Wilson is a Certified Public Accountant and received a B.S. in Business from
the University of California, Berkeley. Angion believes that Ms. Wilson is qualified to serve on Angion’s Board due to her extensive background in financial and accounting matters for public companies and her leadership experience in the life
science industry.
Section 16(a) of the Exchange Act requires Angion’s directors,
executive officers, and persons holding more than 10% of Angion’s common stock to report their initial ownership of the common stock and other equity securities and any changes in that ownership in reports that must be filed with the SEC. The
SEC has designated specific deadlines for these reports, and Angion must identify in Angion’s Annual Report on Form 10-K those persons who did not file these reports when due.
Angion’s directors, executive officers and 10% holders of Angion’s
common stock filed reports during the year ended December 31, 2022. Such reports were filed consistent with the reporting obligations of Section 16(a) of the Exchange Act, except that: (a) each of Dr. Venkatesan and Dr. Goldberg filed one Form
4 late reporting one transaction; and (b) each of Dr. Venkatesan and Mr. Ganzi filed amended Forms 4 on May 27, 2022, reporting that each Dr. Venkatesan and Mr. Ganzi exercised warrants to purchase shares of Angion common stock through a
cashless exercise transaction in which Angion withheld certain shares upon the close of Angion’s initial public offering on February 9, 2021.
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As required under Nasdaq listing standards, a majority of the
members of a listed company’s board of directors must qualify as “independent,” as affirmatively determined by the board of directors. The board of directors consults with Angion’s counsel to ensure that their determinations are consistent with
relevant securities and other laws and regulations regarding the definition of “independent,” including those set forth in pertinent listing standards of Nasdaq, as in effect from time to time.
Consistent with these considerations, after review of all relevant
identified transactions or relationships between each director, or any of his or her family members, and Angion, its senior management and its independent auditors, the board of directors has affirmatively determined that the following four
directors are independent directors within the meaning of the applicable Nasdaq listing standards: Mr. Ganzi, Dr. Nissenson, Dr. Omenn and Ms. Wilson. In making this determination, the board of directors found that none of these directors had a
material or other disqualifying relationship with Angion. Dr. Venkatesan is not considered independent because he is an executive officer of Angion. Dr. Goldberg is not considered independent because he has been an executive officer of Angion
within the past three years.
In addition, as required by The Nasdaq Global Select Market rules,
Angion’s Board has made a subjective determination as to each independent director that no relationships exists that, in the opinion of Angion’s Board, would interfere with the exercise of independent judgment in carrying out the
responsibilities of a director. In making these determinations, Angion’s Board reviewed and discussed information provided by the directors with regard to each director’s business and personal activities and relationships as they may relate to
Angion and Angion’s management. There are no family relationships among any of Angion’s directors or executive officers.
Angion’s Board is currently chaired by the President and Chief
Executive Officer of Angion, Dr. Venkatesan. Angion’s Board has appointed Mr. Ganzi as lead independent director.
In light of its corporate priorities and objectives for 2022,
Angion combined the positions of Chief Executive Officer and Chairman of the Angion Board in January of 2022 to ensure that the board of directors and management act with a common purpose. In Angion’s view, separating the positions of Chief
Executive Officer and Chairman has the potential to give rise to divided leadership, which could interfere with good decision-making or weaken Angion’s ability to develop and implement strategy. Instead, Angion believes that combining the
positions of Chief Executive Officer and Chairman provides a single, clear chain of command to execute Angion’s strategic initiatives and business plans. In addition, Angion believes that a combined Chief Executive Officer/Chairman is better
positioned to act as a bridge between management and the board of directors, facilitating the regular flow of information. Angion also believes that it is advantageous to have a Chairman with an extensive history with and knowledge of Angion
(as is the case with Angion’s Chief Executive Officer) as compared to a relatively less informed independent Chairman.
The Angion Board appointed Mr. Ganzi as the lead independent
director to help reinforce the independence of the Angion Board as a whole. The position of lead independent director has been structured to serve as an effective balance to a combined Chief Executive Officer/Chairman. The lead independent
director is empowered to, among other duties and responsibilities, approve agendas and meeting schedules for regular board of directors meetings, preside over board of directors meetings in the absence of the Chairman, preside over and
establish the agendas for meetings of the independent directors, act as liaison between the Chairman and the independent directors, preside over any portions of board of directors meetings at which the evaluation or compensation of the Chief
Executive Officer is presented or discussed and, as appropriate upon request, act as a liaison to stockholders. In addition, it is the responsibility of the lead independent director to coordinate between the board of directors and management
with regard to the determination and implementation of responses to any problematic risk management issues. As a result, Angion believes the lead independent director can help ensure the effective independent functioning of the board of
directors in its oversight responsibilities. In addition, Angion believes the lead independent director is better positioned to build a consensus among directors and to serve as a conduit between the other independent directors and the
Chairman, for example, by facilitating the inclusion on meeting agendas of matters of concern to the independent directors.
Risk assessment and oversight are an integral part of Angion’s
governance and management processes. Angion’s Board encourages management to promote a culture incorporating risk management into Angion’s corporate strategy
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and day-to-day business operations. Management discusses strategic and operational
risks at regular management meetings and conducts specific strategic planning and review sessions during the year including a focused discussion and analysis of the risks facing Angion. Throughout the year, senior management reviews these risks
with the Board of Directors at regular board meetings as part of management presentations focusing on particular business functions, operations or strategies, and presents the steps taken by management to mitigate or eliminate such risks.
Angion’s Board does not have a standing risk management committee,
but rather administers this oversight function directly through Angion’s Board as a whole, as well as through various standing committees of Angion’s Board addressing risks inherent in their respective areas of oversight.
The Angion Board met 11 times during 2022. Each director attended
75% or more of the aggregate number of meetings of the board of directors and of the committees on which he or she served, held during the portion of 2022 for which he or she was a director or committee member.
As required under applicable Nasdaq listing standards, in fiscal
2022, Angion’s independent directors met nine times in regularly scheduled executive sessions at which only independent directors were present. Angion’s lead independent director presides over the executive sessions.
Below is a description of each committee of the Angion Board.
Each of the committees has authority to engage legal counsel or
other experts or consultants, as it deems appropriate to carry out its responsibilities. The Angion Board has determined each member of each committee meets the applicable Nasdaq rules and regulations regarding “independence” and each member is
free of any relationship that would impair his or her individual exercise of independent judgment with regard to Angion.
Audit Committee
The audit committee of the Angion Board was established by the
board of directors in accordance with Section 3(a)(58)(A) of the Exchange Act, to oversee Angion’s corporate accounting and financial reporting processes and audits of its financial statements. For this purpose, the audit committee performs
several functions, including among other things:
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appoints Angion’s independent registered public accounting firm;
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evaluates the independent registered public accounting firm's qualifications, independence and performance;
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determines the engagement of the independent registered public accounting firm;
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reviews and approves the scope of the annual audit and pre-approves the audit and non-audit fees and services;
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reviews and approves all related party transactions on an ongoing basis;
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establishes procedures for the receipt, retention and treatment of complaints received by Angion regarding accounting,
internal accounting controls or auditing matters;
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discusses with management and the independent registered public accounting firm the results of the annual audit and the
review of Angion’s quarterly financial statements;
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approves the retention of the independent registered public accounting firm to perform any proposed permissible non-audit
services;
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monitors the rotation of partners of the independent registered public accounting firm on Angion’s engagement team in
accordance with requirements established by the SEC;
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discusses on a periodic basis, or as appropriate, with management Angion's policies and procedures with respect to risk
assessment and risk management;
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reviews Angion’s financial statements and Angion’s management's discussion and analysis of financial condition and results of
operations to be included in Angion’s annual and quarterly reports to be filed with the SEC;
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annually reviews and assesses internal controls and treasury functions including cash management procedures;
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investigates any reports received through the ethics helpline and report to the Board of Directors periodically with respect
to the information received through the ethics helpline and any related investigations;
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consults with management to establish procedures and internal controls relating to cybersecurity;
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reviews Angion’s critical accounting policies and estimates; and
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reviews the audit committee charter and the committee's performance at least annually.
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The members of Angion’s audit committee are Karen Wilson, Victor
Ganzi, Allen Nissenson and Gilbert Omenn. Ms. Wilson serves as the chairperson of the committee. All members of Angion’s audit committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and
Nasdaq. Angion’s board of directors has determined that Ms. Wilson is an audit committee financial expert as defined under the applicable rules of the SEC and has the requisite financial sophistication as defined under the applicable rules and
regulations of Nasdaq. Under the rules of the SEC, members of the audit committee must also meet heightened independence standards. Angion’s board of directors has determined that each of Ms. Wilson, Mr. Ganzi, Dr. Nissenson and Dr. Omenn are
independent under the applicable rules of the SEC and Nasdaq. The audit committee operates under a written charter that satisfies the applicable standards of the SEC and Nasdaq.
The Audit Committee met five times during 2022. The Angion Board
has adopted a written Audit Committee charter available to stockholders on Angion’s website at https://ir.angion.com/corporate-governance/governance-overview.
Report of the Audit Committee of the Angion
Board
The Audit Committee has reviewed and discussed with management of
Angion the audited financial statements for the fiscal year ended December 31, 2022. The Audit Committee has discussed with the independent registered public accounting firm the matters required to be discussed by the applicable requirements of
the Public Company Accounting Oversight Board (PCAOB) and the SEC. The Audit Committee has also received the written disclosures and the letter from the independent registered public accounting firm required by applicable requirements of the
PCAOB regarding the independent accountants’ communications with the audit committee concerning independence and has discussed with the independent registered public accounting firm the accounting firm’s independence. Based on the foregoing,
the Audit Committee has recommended to the Board of Directors the audited financial statements be included in Angion’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
Karen J. Wilson, Chair
Victor Ganzi
Allen R. Nissenson, M.D.
Gilbert S. Omenn, M.D., Ph.D.
The material in this report is not “soliciting
material,” is not deemed “filed” with the Commission and is not to be incorporated by reference in any filing by Angion under the Securities Act or the Exchange Act whether made before or after the date hereof and irrespective of any general
incorporation language in any such filing.
Compensation Committee
The Compensation Committee is composed of Allen Nissenson, M.D.,
Victor Ganzi, J.D., Gilbert Omenn, M.D., Ph.D., and Karen Wilson. Dr. Nissenson serves as the chairperson of the committee. Each of the members of Angion’s compensation committee is independent under the applicable rules and regulations of
Nasdaq and is a “non-employee director” as defined in Rule 16b-3 promulgated under the Exchange Act. The Compensation Committee met eight times during 2022. The Angion Board has adopted a written Compensation Committee charter available to
stockholders on Angion’s website at https://ir.angion.com/corporate-governance/governance-overview.
The compensation committee oversees policies relating to
compensation and benefits of Angion’s officers and employees. The compensation committee reviews and approves or recommends to Angion’s Board corporate goals and objectives relevant to compensation of Angion’s executive officers (other than
Angion’s Chief Executive Officer), evaluates the performance of these officers in light of those goals and objectives and approves the
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compensation of these officers based on such evaluations. The compensation
committee also reviews and approves or makes recommendations to Angion’s Board regarding the issuance of stock options and other awards under Angion’s stock plans to Angion’s executive officers (other than Angion’s Chief Executive Officer). The
compensation committee reviews the performance of Angion’s Chief Executive Officer and makes recommendations to Angion’s Board with respect to his compensation and Angion’s Board retains the authority to make compensation decisions relative to
Angion’s Chief Executive Officer. The compensation committee will review and evaluate, at least annually, the performance of the compensation committee and its members, including compliance by the compensation committee with its charter.
Typically, the Compensation Committee meets at least four times
annually and with greater frequency if necessary. The Compensation Committee meets regularly in executive session. However, from time to time, various members of management and other employees as well as outside advisors or consultants may be
invited by the Compensation Committee to make presentations, to provide financial or other background information or advice or to otherwise participate in Compensation Committee meetings. The Chief Executive Officer may not participate in, or
be present during, any deliberations or determinations of the Compensation Committee regarding his compensation or individual performance objectives. The charter of the Compensation Committee grants the Compensation Committee full access to all
books, records, facilities and personnel of Angion. In addition, under the charter, the Compensation Committee has the authority to obtain, at the expense of Angion, advice and assistance from compensation consultants and internal and external
legal, accounting or other advisors and other external resources the Compensation Committee considers necessary or appropriate in the performance of its duties. The Compensation Committee has direct responsibility for the oversight of the work
of any consultants or advisers engaged for the purpose of advising the Committee. In particular, the Compensation Committee has the sole authority to retain, in its sole discretion, compensation consultants to assist in its evaluation of
executive and director compensation, including the authority to approve the consultant’s reasonable fees and other retention terms. Under the charter, the Compensation Committee may select, or receive advice from, a compensation consultant,
legal counsel or other adviser to the compensation committee, other than in-house legal counsel and certain other types of advisers, only after taking into consideration six factors, prescribed by the SEC and Nasdaq, that bear upon the
adviser’s independence; however, there is no requirement that any adviser be independent.
During 2022, after taking into consideration the six factors
prescribed by the SEC and Nasdaq described above, the Compensation Committee engaged Aon as compensation consultants. The Compensation Committee requested that Aon:
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evaluate the efficacy of Angion’s existing compensation strategy and practices in supporting and reinforcing Angion’s
long-term strategic goals; and
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assist in refining Angion’s compensation strategy and in developing and implementing an executive compensation program to
execute that strategy.
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At the request of the Compensation Committee, Aon also conducted
an individual interviews with the chairperson of the Compensation Committee and management to learn more about Angion’s business operations and strategy, key performance metrics and strategic goals, as well as the labor markets in which Angion
competes. Aon ultimately developed recommendations that were presented to the Compensation Committee for its consideration. Following an active dialogue with Aon, the Compensation Committee approved the recommendations of Aon.
Angion’s Board, at the recommendation of Angion’s Compensation
Committee, has also delegated to Angion’s Chief Executive Officer the authority to determine and approve the equity compensation payable to Angion’s employees and consultants who are not “officers” (as defined in Section 16 of the Exchange
Act).
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committee of the Angion
Board is responsible for making recommendations to Angion’s Board regarding candidates for directorships and the size and composition of Angion’s Board. In addition, the nominating and corporate governance committee will be responsible for
overseeing Angion’s corporate governance policies and reporting and making recommendations to Angion’s Board concerning governance matters.
The Nominating and Corporate Governance Committee is composed of
Gilbert Omenn, M.D., Ph.D., Victor Ganzi, J.D., Allen Nissenson, M.D., and Karen Wilson. Dr. Omenn serves as the chairperson of the committee. Each of the members of Angion’s nominating and corporate governance committee is independent under
the applicable
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rules and regulations of Nasdaq relating to nominating and corporate governance
committee independence. The Nominating and Corporate Governance Committee met one time during 2022, in light of Angion’s 2022 Strategic Realignment. The Angion Board has adopted a written Nominating and Corporate Governance Committee charter
available to stockholders on Angion’s website at https://ir.angion.com/corporate-governance/governance-overview.
The Nominating and Corporate Governance Committee believes
candidates for director should have certain minimum qualifications, including the ability to read and understand basic financial statements, and have the highest personal integrity and ethics. The Nominating and Corporate Governance Committee
also considers such factors as possessing relevant expertise upon which to be able to offer advice and guidance to management, having sufficient time to devote to the affairs of Angion, demonstrated excellence in his or her field, having the
ability to exercise sound business judgment and having the commitment to rigorously represent the long-term interests of Angion’s stockholders. However, the Nominating and Corporate Governance Committee retains the right to modify these
qualifications from time to time. Candidates for director nominees are reviewed in the context of the current composition of the Angion’s Board, the operating requirements of Angion and the long-term interests of stockholders. In conducting
this assessment, the Nominating and Corporate Governance Committee typically considers diversity (including gender, racial and ethnic diversity), age, skills and such other factors as it deems appropriate, given the current needs of the
Angion’s Board and Angion, to maintain a balance of knowledge, experience and capability. The Nominating and Corporate Governance Committee appreciates the value of thoughtful Board refreshment, and regularly identifies and considers qualities,
skills and other director attributes that would enhance the composition of the Angion’s Board. The Committee takes into account the results of the Angion’s Board’ self-evaluation, conducted annually on a group and individual basis. Due to
Angion’s 2022 Strategic Realignment, on November 17, 2022, the Board deferred the conduct of the annual Board and Committee self-evaluations until at least the completion of that process. In the case of new director candidates, the Nominating
and Corporate Governance Committee also determines whether the nominee is independent for Nasdaq purposes, which determination is based upon applicable Nasdaq listing standards, applicable SEC rules and regulations and the advice of counsel, if
necessary. The Nominating and Corporate Governance Committee then uses its network of contacts to compile a list of potential candidates, but may also engage, if it deems appropriate, a professional search firm. The Nominating and Corporate
Governance Committee conducts any appropriate and necessary inquiries into the backgrounds and qualifications of possible candidates after considering the function and needs of the Angion’s Board. The Nominating and Corporate Governance
Committee meets to discuss and consider the candidates’ qualifications and then selects a nominee for recommendation to the Angion’s Board by majority vote.
Policy and Procedures by Which Security holders
May Recommend Nominees to the Board of Directors
The Nominating and Corporate Governance Committee of the Angion
Board has adopted policy and procedures for considering director candidates recommended by stockholders. Stockholders who wish to recommend individuals for consideration by the Committee as candidates for potential election by the Angion Board
as directors, can deliver a written recommendation to the Corporate at Angion Biomedica Corp., 7-57 Wells Avenue, Newton, Massachusetts 02459, at least 120 days prior to the anniversary date of the mailing of the proxy statement for the last
annual meeting of stockholders and must include the following information: name and address of the nominating stockholder; a representation that the nominating stockholder is a record holder; a representation that the nominating stockholder
intends to appear in person or by proxy at the annual meeting to nominate the person or persons specified; information regarding each nominee that would be required to be included in a proxy statement; a description of any arrangements or
understandings between the nominating stockholder and the nominee; and the consent of each nominee to serve as a director, if elected.
The Nominating and Corporate Governance Committee will evaluate
candidates recommended by a stockholder in the same manner as candidates identified any other person, including members of the Angion Board.
Historically, Angion has not provided a formal process related to
stockholder communications with the Angion Board. Nevertheless, every effort has been made to ensure the views of stockholders are heard by the Angion Board or individual directors, as applicable, and appropriate responses are provided to
stockholders in a timely manner. Angion believes its responsiveness to stockholder communications to the board of directors has been excellent. Nevertheless, during the upcoming year, the Nominating and Corporate Governance Committee will give
full consideration to the adoption of a formal process for stockholder communications with the board of directors and, if adopted, publish it promptly and post it to Angion’s website.
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Angion has adopted the Angion Code of Business Conduct and Ethics
applying to all officers, directors and employees. The Code of Business Conduct and Ethics is available on Angion’s website at https://ir.angion.com/corporate-governance/governance-overview. If Angion makes any substantive amendments to the
Code of Business Conduct and Ethics or grants any waiver from a provision of the Code to any executive officer or director, Angion will promptly disclose the nature of the amendment or waiver on its website.
In January 2021, the Angion Board documented the governance
practices followed by Angion by adopting Corporate Governance Guidelines to assure the Angion Board will have the necessary authority and practices in place to review and evaluate Angion’s business operations as needed and to make decisions
that are independent of Angion’s management. The guidelines are also intended to align the interests of directors and management with those of Angion’s stockholders. The Corporate Governance Guidelines set forth the practices the Angion Board
intends to follow with respect to board composition and selection including diversity, board meetings and involvement of senior management, and board committees and compensation. The Corporate Governance Guidelines, as well as the charters for
each committee of the Angion Board, may be viewed at https://ir.angion.com/corporate-governance/governance-overview.
As part of Angion’s insider trading policy, all employees,
including Angion’s executive officers, and non-employee directors are prohibited from engaging in short sales of Angion’s securities, establishing margin accounts, pledging Angion’s securities as collateral for a loan, buying or selling puts or
calls on Angion’s securities or otherwise engaging in hedging transactions (such as zero-cost dollars, exchange funds, and forward sale contracts) involving Angion’s securities.
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APPROVAL OF THE ISSUANCE OF SHARES OF ANGION COMMON STOCK
PURSUANT TO THE MERGER
At the Angion special meeting, Angion’s common stockholders will
be asked to approve the issuance of Angion common stock to Elicio’s stockholders pursuant to the Merger Agreement, which shares of Angion common stock to be issued pursuant to the Merger will represent more than 20% of the shares of Angion
common stock outstanding immediately prior to the Merger and result in a change of control resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b). Immediately following the Merger, the pre-Merger equity holders of
Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each
case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. Angion will assume outstanding warrants to purchase shares of Elicio capital stock and
unexercised options to purchase shares of Elicio capital stock, and such securities will be converted into warrants or options, as applicable, to purchase shares of Angion common stock.
The terms of, reasons for and other aspects of the Merger
Agreement, the Merger, the issuance of Angion common stock pursuant to the Merger Agreement are described in detail in the other sections in this proxy statement/prospectus/information statement.
The affirmative vote of a majority of the votes cast virtually or
by proxy at the Angion special meeting is required to approve Proposal No. 1. Abstentions and broker non-votes will have no effect on the outcome of this proposal. It is anticipated that Proposal No. 1 will be a non-discretionary proposal
considered non-routine under the rules of the NYSE, which generally controls the ability of brokers to vote or not vote shares held in street name on certain matters, and thus may result in broker non-votes.
THE ANGION BOARD RECOMMENDS THAT ANGION’S COMMON STOCKHOLDERS
VOTE “FOR” PROPOSAL NO. 1 TO APPROVE THE ISSUANCE OF SHARES OF ANGION COMMON STOCK PURSUANT TO THE MERGER. THE APPROVAL OF EACH OF PROPOSAL NOS. 1 AND 2 IS REQUIRED TO CONSUMMATE THE MERGER.
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APPROVAL OF AN AMENDMENT TO THE ANGION AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION EFFECTING THE REVERSE STOCK SPLIT
AT A RATIO IN THE RANGE FROM 5-FOR-1 TO 30-FOR-1
At the Angion special meeting, Angion’s common stockholders will
be asked to approve an amendment to the amended and restated certificate of incorporation of Angion effecting the Reverse Stock Split of Angion common stock at a ratio anywhere in the range between one new share for every five shares and one
new share for every 30 shares outstanding. Prior to the effectiveness of the Merger, Angion and Elicio will mutually agree upon the exact reverse split ratio within such range. Upon the effectiveness of the amendment to the amended and restated
certificate of incorporation of Angion effecting the Reverse Stock Split, or the split effective time, the issued shares of Angion common stock immediately prior to the split effective time will be reclassified into a smaller number of shares
within the specified range, such that a stockholder of Angion will own one new share of Angion common stock for the specified number of shares of issued common stock held by that stockholder immediately prior to the split effective time.
If Proposal No. 2 is approved, the Reverse Stock Split would
become effective immediately prior to the effectiveness of the Merger. Angion may effect only one reverse stock split in connection with this Proposal No. 2. Angion and Elicio’s mutual decision will be based on a number of factors, including
market conditions, existing and expected trading prices for Angion common stock and the listing requirements of Nasdaq.
If Proposal No. 2 is not approved and the Merger is not effected,
the Angion Board may still choose to implement the Reverse Stock Split in order to effectively increase the per share price of Angion common stock.
The form of the amendment to the amended and restated certificate
of incorporation of Angion to effect the Reverse Stock Split, as more fully described below, will effect the Reverse Stock Split but will not change the number of authorized shares of common stock or preferred stock, or the par value of Angion
common stock or preferred stock.
The Angion Board approved the proposal approving the amendment to
the amended and restated certificate of incorporation of Angion effecting the Reverse Stock Split for the following reasons:
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the Angion Board believes effecting the Reverse Stock Split may be an effective means of satisfying the Nasdaq initial
listing requirements for Angion common stock following the closing of the Merger;
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the Angion Board believes that the Reverse Stock Split will result in a number of authorized but unissued shares of Angion
common stock sufficient for the issuance of shares of Angion common stock to Elicio’s stockholders pursuant to the Merger Agreement; and
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the Angion Board believes a higher stock price may help generate investor interest in Angion and help Angion attract and
retain employees.
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If the Reverse Stock Split successfully increases the per share
price of Angion common stock, the Angion Board believes this increase may increase trading volume in Angion common stock and facilitate future financings by the combined company.
Angion common stock is listed on The Nasdaq Global Select Market
under the symbol “ANGN.” Angion intends to file an initial listing application with Nasdaq, as described below, to seek a listing upon the closing of the Merger. According to Nasdaq rules, an issuer must, in a case such as this, apply for
initial inclusion following a transaction whereby the issuer combines with a non-Nasdaq entity, resulting in a change of control of the issuer and potentially allowing the non-Nasdaq entity to obtain a Nasdaq listing. Accordingly, the listing
standards of Nasdaq will require Angion to have, among other things, a $4.00 per share minimum bid price upon the closing of the Merger. Therefore, the Reverse Stock Split may be necessary in order to consummate the Merger.
One of the effects of the Reverse Stock Split will be to
effectively increase the proportion of authorized shares which are unissued relative to those which are issued. This could result in Angion’s management being able to issue
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more shares without further stockholder approval. For example, before the Reverse
Stock Split, as of April 17, 2023, Angion’s authorized shares of common stock immediately prior to the closing of the Merger is 300,000,000 compared to shares issued and outstanding of 30,114,190. If Angion effects the Reverse Stock Split using
a 10:1 ratio, its authorized shares of common stock immediately prior to the closing of the Merger would still be 300,000,000 compared to shares issued and outstanding of approximately 3,011,419. Angion currently has no plans to issue shares,
other than in connection with the Merger and to satisfy obligations under the Angion employee stock options from time to time as the options are exercised. The Reverse Stock Split will not affect the number of authorized shares of Angion common
stock which will continue to be authorized pursuant to the certificate of incorporation of Angion.
On April 25, 2023, Angion common stock closed at $0.75 per
share. An investment in Angion common stock may not appeal to brokerage firms that are reluctant to recommend lower priced securities to their clients. Investors may also be dissuaded from purchasing lower priced stocks because the brokerage
commissions, as a percentage of the total transaction, tend to be higher for such stocks. Moreover, the analysts at many brokerage firms do not monitor the trading activity or otherwise provide coverage of lower priced stocks. Also, the
Angion Board believes that most investment funds are reluctant to invest in lower priced stocks.
There are risks associated with the Reverse Stock Split, including
that the Reverse Stock Split may not result in an increase in the per share price of Angion common stock.
Angion cannot predict whether the Reverse Stock Split will
increase the market price for Angion common stock in the future. The history of similar stock split combinations for companies in like circumstances is varied. There is no assurance that:
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the market price per share of Angion common stock after the Reverse Stock Split will rise in proportion to the reduction in
the number of shares of Angion common stock outstanding before the Reverse Stock Split;
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the Reverse Stock Split will result in a per share price that will attract brokers and investors who do not trade in lower
priced stocks;
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the Reverse Stock Split will result in a per share price that will increase the ability of Angion to attract and retain
employees;
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the market price per share will either exceed or remain in excess of the $1.00 minimum bid price as required by Nasdaq for
continued listing, or that Angion will otherwise meet the requirements of Nasdaq for inclusion for trading on Nasdaq, including the $4.00 minimum bid price upon the closing of the Merger.
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The market price of Angion common stock will also be based on
performance of Angion and other factors, some of which are unrelated to the number of shares outstanding. If the Reverse Stock Split is effected and the market price of Angion common stock declines, the percentage decline as an absolute number
and as a percentage of the overall market capitalization of Angion may be greater than would occur in the absence of a reverse stock split. Furthermore, the liquidity of Angion common stock could be adversely affected by the reduced number of
shares that would be outstanding after the Reverse Stock Split.
In determining which reverse stock split ratio to implement, if
any, following receipt of stockholder approval of the Reverse Stock Split Proposal, Angion and/or Elicio may consider, among other things, various factors, such as:
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the historical trading price and trading volume of Angion common stock;
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the then-prevailing trading price and trading volume of Angion common stock and the expected impact of the reverse stock
split on the trading market for Angion common stock in the short- and long-term;
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the ability of Angion to continue its listing on the Nasdaq Global Select Market;
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which reverse stock split ratio would result in the least administrative cost to Angion; and
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prevailing general market and economic conditions.
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The failure of Angion stockholders to approve the Reverse Stock
Split Proposal could have serious, adverse effects on Angion and its stockholders. Angion could be delisted from Nasdaq if shares of Angion common stock may begin to trade below the requisite $1.00 per share bid price needed to maintain its
listing. If Nasdaq delists Angion common stock, Angion shares may then trade on the OTC Bulletin Board or other small trading markets, such as the pink sheets. In that event, Angion common stock could trade thinly as a microcap or penny stock,
adversely decrease to nominal levels of trading and be avoided by retail and institutional investors, resulting in the impaired liquidity of Angion common stock and making it difficult to raise additional capital if needed.
The amendment to the amended and restated certificate of
incorporation of Angion effecting the Reverse Stock Split would revise Article IV of the amended and restated certificate of incorporation of Angion to read in its entirety as follows (with the time and ratio chosen within the range described
above filled in):
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The Corporation is authorized to issue two classes of stock to be
designated, respectively, “Common Stock” and “Preferred Stock.” The total number of shares of capital stock which the Corporation shall have authority to issue is 310,000,000. The total number of shares of Common Stock that the
Corporation is authorized to issue is 300,000,000, having a par value of $0.01 per share, and the total number of shares of Preferred Stock that the Corporation is authorized to issue is 10,000,000, having a par value of $0.01 per
share. Effective at on (the “Effective Time”) pursuant to Section 242 of the DGCL, each ( ) shares of the Corporation’s Common Stock, par value of
$0.01 per share, issued and outstanding immediately prior to the Effective Time shall automatically without further action on the part of the Corporation or any holder of such Common Stock, be reclassified, combined, converted and
changed into one (1) fully paid and nonassessable share of Common Stock, par value of $0.01 per share, subject to the treatment of fractional share interests as described below (the “Reverse Stock Split”).
Notwithstanding the immediately preceding sentence, no fractional shares shall be issued as a result of the reverse stock split. Instead, any stockholder who would otherwise be entitled to a fractional share of Common Stock as a result
of the Reverse Stock Split shall be entitled to receive a cash payment equal to the product of such resulting fractional interest in one share of Common Stock multiplied by the closing trading price of a share of Common Stock on the
last trading day immediately prior to the date on which the Effective Time occurs. Each certificate that immediately prior to the Effective Time represented shares of Common Stock (“Old Certificates”),
shall thereafter represent that number of shares of Common Stock into which the shares of Common Stock represented by the Old Certificate shall have been combined, subject to the elimination of fractional share interests as described
above.
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The Reverse Stock Split will be effected simultaneously for all
outstanding shares of Angion common stock. The Reverse Stock Split will affect all of Angion’s stockholders uniformly and will not affect any stockholder’s percentage ownership interest in Angion, except to the extent that the Reverse Stock
Split results in any of Angion’s stockholders owning a fractional share. Shares of Angion common stock issued pursuant to the Reverse Stock Split will remain fully paid and nonassessable. The Reverse Stock Split does not affect the total
proportionate ownership of Angion following the Merger. The Reverse Stock Split will not affect Angion continuing to be subject to the periodic reporting requirements of the Exchange Act.
As an example, the following table illustrates the effects of a
5-for-1 to 30-for-1 reverse stock split (without giving effect to the treatment of fractional shares):
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Prior to Reverse
Stock Split
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After 5-for-1
Reverse Stock
Split
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After 30-for-1
Reverse Stock
Split
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Common stock outstanding
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30,114,190
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6,022,838
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1,003,806
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Common stock issuable pursuant to outstanding equity awards(1)
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3,695,488
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739,097
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123,182
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(1)
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Includes 15,802 restricted stock units. Substantially all options underlying these awards have an exercise price higher than
$ per share, the closing price of Angion common stock on , 2023.
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In addition, if the reverse stock split is implemented, it will
increase the number of Angion stockholders who own “odd lots” of fewer than 100 shares of common stock. Brokerage commission and other costs of transactions in odd lots are generally higher than the costs of transactions of more than 100 shares
of common stock. Accordingly, the reverse stock split may not achieve the desired results of increasing marketability and liquidity of Angion common stock that have been described above.
After the effective date of the reverse stock split, Angion common
stock would have a new committee on uniform securities identification procedures (CUSIP number), a number used to identify Angion common stock.
Angion common stock is currently registered under Section 12(b) of
the Exchange Act, and Angion is subject to the periodic reporting and other requirements of the Exchange Act. The proposed reverse stock split will not affect the registration of the common stock under the Exchange Act.
If Angion’s common stockholders approve the amendment to the
amended and restated certificate of incorporation of Angion effecting the Reverse Stock Split, and if the Angion Board still believes that a reverse stock split is in the best interests of Angion and its stockholders, Angion will file the
amendment to the amended and restated certificate of incorporation with the Secretary of State of the State of Delaware at such time as the Angion Board has determined to be the appropriate split effective time. The Angion Board may delay
effecting the Reverse Stock Split without resoliciting stockholder approval. Beginning at the split effective time, each certificate representing pre-split shares will be deemed for all corporate purposes to evidence ownership of post-split
shares.
Beneficial Owners of Common Stock. Upon the implementation of the reverse stock split, Angion intends to treat shares held by stockholders in “street name” (i.e., through a bank, broker, custodian or other nominee), in the same manner as registered
stockholders whose shares are registered in their names. Banks, brokers, custodians or other nominees will be instructed to effect the reverse stock split for their beneficial holders holding Angion common stock in street name. However, these
banks, brokers, custodians or other nominees may have different procedures than registered stockholders for processing the reverse stock split and making payment for fractional shares. If a stockholder holds shares of Angion common stock with
a bank, broker, custodian or other nominee and has any questions in this regard, stockholders are encouraged to contact their bank, broker, custodian or other nominee.
Registered Holders of Common Stock in
Book-Entry Form. Certain of Angion’s registered holders of common stock hold some or all of their shares electronically in book-entry form with Angion’s transfer agent, Continental Stock Transfer & Trust
Company, LLC. These stockholders do not hold physical stock certificates evidencing their ownership of Angion common stock. However, they are provided with a statement reflecting the number of shares of Angion common stock registered in their
accounts. If a stockholder holds registered shares in book-entry form with Angion’s transfer agent, no action needs to be taken to receive post-reverse stock split shares or payment in lieu of fractional shares, if applicable. If a
stockholder is entitled to post-reverse stock split shares, a transaction statement will automatically be sent to the stockholder’s address of record indicating the number of shares of Angion common stock held following the reverse stock
split.
Registered Holders of Common Stock in
Certificate Form. As soon as practicable after the split effective time, Angion’s stockholders will be notified that the Reverse Stock Split has been effected. Angion expects that the Angion transfer agent will
act as exchange agent for purposes of implementing the exchange of stock certificates. Holders of pre-split shares will be asked to surrender to the exchange agent certificates representing pre-split shares held in certificated form in
exchange for certificates representing post-split shares in accordance with the procedures to be set forth in a letter of transmittal to be sent by Angion. No new certificates will be issued to a stockholder until such stockholder has
surrendered such stockholder’s outstanding certificate(s) together with the properly completed and executed letter of transmittal to the exchange agent. Any pre-split shares submitted for transfer, whether pursuant to a sale or other
disposition, or otherwise, will automatically be exchanged for post-split shares. Stockholders should not destroy any stock certificate(s) and should not submit any certificate(s)
unless and until requested to do so.
No fractional shares will be issued in connection with the Reverse
Stock Split. Stockholders of record who otherwise would be entitled to receive fractional shares because they hold a number of pre-split shares not evenly divisible by the number of pre-split shares for which each post-split share is to be
reclassified, will be entitled, upon
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surrender to the exchange agent of certificates representing such shares, to a
cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise be entitled multiplied by the closing price of the common stock on Nasdaq on the date immediately preceding the split effective time. The
ownership of a fractional interest will not give the holder thereof any voting, dividend, or other rights except to receive payment therefor as described herein.
By approving the amendment to the amended and restated certificate
of incorporation of Angion effecting the Reverse Stock Split, stockholders will be approving the combination of a whole number of shares of Angion common stock between 5 to 30 into one share of Angion common stock, with the actual ratio to be
mutually agreed upon by Angion and Elicio prior to the effectiveness of the Merger.
Stockholders should be aware that, under the escheat laws of the
various jurisdictions where stockholders reside, where Angion is domiciled, and where the funds will be deposited, sums due for fractional interests that are not timely claimed after the effective date of the split may be required to be paid to
the designated agent for each such jurisdiction, unless correspondence has been received by Angion or the exchange agent concerning ownership of such funds within the time permitted in such jurisdiction. Thereafter, stockholders otherwise
entitled to receive such funds will have to seek to obtain them directly from the state to which they were paid.
The par value per share of Angion common stock will remain
unchanged at $0.01 per share after the reverse stock split. As a result, at the reverse stock split effective time, the stated capital on Angion’s balance sheet attributable to Angion common stock will be reduced proportionately based on the
reverse stock split ratio, from its present amount, and the additional paid-in capital account will be increased for the amount by which the stated capital is reduced. After the reverse stock split (and disregarding the impact of shares of
Angion common stock issued in the merger), net income or loss per share, and other per share amounts will be increased because there will be fewer shares of Angion common stock outstanding. In future financial statements, net income or loss per
share and other per share amounts for periods ending before the reverse stock split will be recast to give retroactive effect to the reverse stock split.
Although the increased proportion of unissued authorized shares to
issued shares could, under certain circumstances, have an anti-takeover effect, for example, by permitting issuances that would dilute the stock ownership of a person seeking to effect a change in the composition of the Angion Board or
contemplating a tender offer or other transaction for the combination of Angion with another company, the Reverse Stock Split Proposal is not being proposed in response to any effort of which Angion is aware to accumulate shares of Angion
common stock or obtain control of Angion, other than in connection with the Merger, nor is it part of a plan by management to recommend a series of similar amendments to the Angion Board and stockholders. Other than the proposals being
submitted to Angion’s common stockholders for their consideration at the Angion special meeting, the Angion Board does not currently contemplate recommending the adoption of any other actions that could be construed to affect the ability of
third parties to take over or change control of Angion. For more information, please see the sections titled “Risk Factors—Risks related to the Combined Company”, and “Description
of Angion Capital Stock—Anti-Takeover Effects of Provisions of Angion’s Charter Documents and Delaware Law.”
The following is a discussion of material U.S. federal income tax
consequences of the Reverse Stock Split that are applicable to U.S. holders (as defined below) of Angion common stock, but does not purport to be a complete analysis of all potential tax effects. This summary is based upon current provisions of
the Code, existing Treasury regulations, judicial decisions, and published rulings and administrative pronouncements of the IRS, all in effect as of the date hereof and all of which are subject to differing interpretations or change. Any such
change or differing interpretation, which may be retroactive, could alter the tax consequences to Angion stockholders as described in this summary.
This summary does not address U.S. federal income tax consequences
that may be relevant to particular Angion stockholders in light of their personal circumstances or to Angion stockholders who are subject to special treatment under U.S. federal income tax laws, such as Angion stockholders who: do not hold
their Angion common stock as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment); are banks,
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insurance companies, tax-exempt entities, mutual funds, financial institutions,
real estate investment trusts, regulated investment companies, government entities or broker-dealers; hold their Angion common stock as “qualified small business stock” under Section 1202 of the Code or as “Section 1244 stock” under Section
1244 of the Code; hold their Angion common stock as part of a hedging, “straddle,” conversion or other integrated transaction or are treated as having sold their Angion common stock pursuant to the constructive sale provisions of the Code; are
not U.S. holders (as defined below); acquired their Angion common stock pursuant to the exercise of compensatory options, or in other compensatory transactions; acquired their Angion common stock pursuant to the exercise of warrants or
conversion rights under convertible instruments; are subject to special tax accounting rules under Section 451(b) of the Code; hold their Angion common stock through individual retirement or other tax-deferred accounts; acquired their Angion
common stock in a transaction subject to the gain rollover provisions of Section 1045 of the Code; have a functional currency other than the U.S. dollar; or are partnerships or entities or arrangements classified as partnerships or disregarded
entities for U.S. federal income tax purposes, S corporations, or other pass-through entities (including hybrid entities) and investors therein.
Angion stockholders subject to particular U.S. or non-U.S. tax
rules that are described in this paragraph are urged to consult their own tax advisors regarding the consequences to them of the Reverse Stock Split.
If an entity that is treated as a partnership for U.S. federal
income tax purposes holds Angion common stock, the U.S. federal income tax treatment of a partner in the partnership will depend upon the status of the partner, the activities of the partnership and certain determinations made at the partner
level. If you are a partnership or a partner of a partnership holding Angion capital stock or any other person not addressed by this discussion, you should consult your tax advisors regarding the tax consequences of the Reverse Stock Split.
In addition, the following discussion does not address: (a) the
tax consequences of transactions effectuated before, after or at the same time as the Reverse Stock Split, whether or not they are in connection with the Reverse Stock Split; (b) any U.S. federal non-income tax consequences of the Reverse Stock
Split, including estate, gift or other tax consequences; (c) any state, local or non-U.S. tax consequences of the Reverse Stock Split; or (d) the Medicare contribution tax on net investment income. No ruling from the IRS or opinion of counsel,
has been or will be requested in connection with the Reverse Stock Split. Angion stockholders should be aware that the IRS could adopt a position which could be sustained by a court contrary to that set forth in this discussion.
Definition of “U.S. Holder”
For purposes of this discussion, a “U.S. holder” is a beneficial
owner of Angion common stock that is, for U.S. federal income tax purposes:
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an individual who is a citizen or resident of the United States;
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a corporation or any other entity taxable as a corporation created or organized in or under the laws of the United States,
any state thereof, or the District of Columbia;
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a trust if either (i) a court within the United States is able to exercise primary supervision over the administration of
such trust, and one or more United States persons (within the meaning of Section 7701(a)(30) of the Code) are authorized or have the authority to control all substantial decisions of such trust, or (ii) the trust was in existence on
August 20, 1996 and has a valid election in effect under applicable Treasury Regulations to be treated as a United States person for U.S. federal income tax purposes; or
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an estate, the income of which is subject to U.S. federal income tax regardless of its source.
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Treatment of U.S. Holders in the Reverse Stock
Split
Angion intends to treat the Reverse Stock Split as a
“recapitalization” for U.S. federal income tax purposes within the meaning of Section 368(a) of the Code. Assuming the Reverse Stock Split qualifies as a recapitalization within the meaning of Section 368(a) of the Code, a U.S. holder will not
recognize gain or loss upon the Reverse Stock Split, except with respect to cash received in lieu of a fractional share of Angion common stock (which fractional share will be treated as received and then exchanged for such cash). A U.S.
holder’s aggregate tax basis in the shares of Angion common stock received pursuant to the Reverse Stock Split will equal the aggregate tax basis of the shares of the Angion common stock surrendered (excluding any portion of such basis that is
allocated to any fractional share of Angion common stock), and such U.S. holder’s holding period in the shares of Angion common
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stock received will include the holding period in the shares of Angion common
stock surrendered. Treasury Regulations provide detailed rules for allocating the tax basis and holding period of the shares of Angion common stock surrendered to the shares of Angion common stock received in a recapitalization pursuant to the
Reverse Stock Split. U.S. holders of shares of Angion common stock acquired on different dates and at different prices should consult their tax advisors regarding the allocation of the tax basis and holding period of such shares.
A U.S. holder that receives cash in lieu of a fractional share of
Angion common stock pursuant to the Reverse Stock Split will generally recognize capital gain or loss in an amount equal to the difference between the amount of cash received and the U.S. holder’s tax basis in the shares of Angion common stock
surrendered that is allocated to such fractional share of Angion common stock. Any such gain or loss will be long-term capital gain or loss if, as of the effective time of the Reverse Stock Split, the U.S. holder’s holding period for such
fractional share exceeds one year. Long-term capital gains of certain non-corporate taxpayers, including individuals, are generally taxed at preferential rates. The deductibility of capital losses is subject to limitations.
Information Reporting and Backup Withholding
If the Reverse Stock Split qualifies as a recapitalization within
the meaning of Section 368(a) of the Code, each U.S. holder who receives shares of Angion common stock in the Reverse Stock Split is required to retain permanent records pertaining to the Reverse Stock Split, and make such records available to
any authorized IRS officers and employees. Such records should specifically include information regarding the amount, basis, and fair market value of all transferred property, and relevant facts regarding any liabilities assumed or extinguished
as part of such reorganization. U.S. holders who owned immediately before the Reverse Stock Split at least five percent (by vote or value) of the total outstanding stock of Angion is required to attach a statement to their tax returns for the
year in which the Reverse Stock Split is consummated that contains the information listed in Treasury Regulation Section 1.368-3(b). Such statement must include the U.S. holder’s tax basis in such holder’s Angion common stock surrendered in the
Reverse Stock Split, the fair market value of such stock, the date of the Reverse Stock Split and the name and employer identification number of Angion. U.S. holders are urged to consult with their tax advisors to comply with these rules.
A U.S. holder may be subject to information reporting and backup
withholding for U.S. federal income tax purposes on cash paid in lieu of fractional shares in connection with the Reverse Stock Split. Backup withholding will not apply, however, to a U.S. holder who (i) furnishes a correct taxpayer
identification number and certifies the holder is not subject to backup withholding on IRS Form W-9 or a substantially similar form, or (ii) certifies the holder is otherwise exempt from backup withholding. If a U.S. holder does not provide a
correct taxpayer identification number on IRS Form W-9 or other proper certification, the stockholder may be subject to penalties imposed by the IRS. Any amounts withheld under the backup withholding rules may be refunded or allowed as a credit
against the federal income tax liability of a U.S. holder of Angion capital stock, if any, provided the required information is timely furnished to the IRS. U.S. holders should consult their tax advisors regarding their qualification for an
exemption from backup withholding, the procedures for obtaining such an exemption, and in the event backup withholding is applied, to determine if any tax credit, tax refund or other tax benefit may be obtained.
The foregoing summary is of a general nature only and is not
intended to be, and should not be construed to be, legal, business or tax advice to any particular Angion stockholder. This summary does not take into account your particular circumstances and does not address consequences that may be
particular to you. Therefore, you should consult your tax advisor regarding the particular consequences of the Reverse Stock Split to you.
The affirmative vote of holders of a majority of the shares of
Angion common stock outstanding on the record date for the Angion special meeting is required to approve Proposal No. 2. Abstentions will have the same effect as votes “AGAINST” this Proposal. It is
anticipated that Proposal No. 2 will be a discretionary proposal considered routine under the rules of the NYSE, which generally controls the ability of brokers to vote or not vote shares held in street name on certain matters, and thus will
not result in broker non-votes.
THE ANGION BOARD RECOMMENDS THAT ANGION’S COMMON STOCKHOLDERS
VOTE “FOR” PROPOSAL NO. 2 TO APPROVE THE AMENDMENT TO THE ANGION AMENDED AND RESTATED CERTIFICATE OF INCORPORATION EFFECTING THE REVERSE STOCK SPLIT. THE APPROVAL OF EACH OF PROPOSAL NOS. 1 AND 2 IS REQUIRED TO CONSUMMATE THE MERGER.
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EXCULPATION OF OFFICERS
Section 102(b)(7) of the DGCL was amended effective August 1, 2022
to authorize exculpation of officers of Delaware corporations (Section 102(b)(7) Amendment). Specifically, the amendments extend the opportunity for Delaware corporations to exculpate their officers, in addition to their directors, for personal
liability for breach of the duty of care in certain actions. This provision would not exculpate officers from liability for breach of the duty of loyalty, acts or omissions not in good faith or that involve intentional misconduct or a knowing
violation of law, or any transaction in which the officer derived an improper personal benefit. Nor would this provision exculpate such officers from liability for claims brought by or in the right of the corporation, such as derivative claims.
The Board believes it is necessary to provide protection to
officers to the fullest extent permitted by law in order to attract and retain top talent. This protection has long been afforded to directors. Accordingly, the Board believes that the proposal to extend exculpation to officers is fair and in
the best interests of the corporation and its stockholders.
If the stockholders approve this proposal, Angion will file a
Certificate of Amendment to its amended and restated certificate of incorporation (Exculpation Amendment). In accordance with the DGCL, however, Angion’s Board may elect to abandon the Exculpation Amendment without further action by the
stockholders at any time prior to the effectiveness of the filing of the Exculpation Amendment with the Secretary of State of the State of Delaware, notwithstanding stockholder approval of the Exculpation Amendment.
The amendment to the amended and restated certificate of
incorporation of Angion effecting the Exculpation Amendment would add a new Article XII to the amended and restated certificate of incorporation of Angion to read in its entirety as follows:
ARTICLE XII
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No officer of the Corporation shall have any personal liability to the
Corporation or its stockholders for monetary damages for any breach of fiduciary duty as a officer, except to the extent such exemption from liability or limitation thereof is not permitted under the DGCL as the same exists or hereafter
may be amended. Any amendment, repeal or modification of this Article XII, or the adoption of any provision of the Restated Certificate inconsistent with this Article XII, shall not adversely affect any right or protection of an officer
of the Corporation with respect to any act or omission occurring prior to such amendment, repeal, modification or adoption. If the DGCL is amended after approval by the stockholders of this Article XII to authorize corporate action
further eliminating or limiting the personal liability of officers, then the liability of an officer of the Corporation shall be eliminated or limited to the fullest extent permitted by the DGCL as so amended.
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The Board desires to amend its Charter to maintain provisions
consistent with the governing statutes contained in the DCGL. Prior to the Section 102(b)(7) Amendment, Delaware law has permitted Delaware corporations to exculpate directors from personal liability for monetary damages associated with
breaches of the duty of care, but that protection did not extend to a Delaware corporation’s officers. Consequently, stockholder plaintiffs have employed a tactic of bringing certain claims that would otherwise be exculpated if brought against
directors, against individual officers to avoid dismissal of such claims. The Section 102(b)(7) Amendment was adopted to address inconsistent treatment between officers and directors and address rising litigation and insurance costs for
stockholders.
As is currently the case with directors under Angion’s Charter,
this provision would not exculpate officers from liability for breach of the duty of loyalty, acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law, or any transaction in which the officer
derived an improper personal benefit. Nor would this provision exculpate such officers from liability for claims brought by or in the right of the corporation, such as derivative claims. The Board believes it is necessary to provide protection
to officers to the fullest extent permitted by law in order to attract and retain top talent. This protection has long been afforded to directors, and accordingly, the Board believes that this proposal which would extend exculpation to
officers, as specifically permitted by the Section 102(b)(7) Amendment, is fair and in the best interests of Angion and its stockholders.
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The affirmative vote of holders of a majority of the shares of
Angion common stock outstanding on the record date for the Angion special meeting is required to approve Proposal No. 3. Abstentions and broker non-votes will have the same effect as votes “AGAINST” this
Proposal. It is anticipated that Proposal No. 3 will be a considered non-routine under the rules of the NYSE, which generally controls the ability of brokers to vote or not vote shares held in street name on certain matters, and thus will
result in broker non-votes.
THE ANGION BOARD RECOMMENDS THAT ANGION’S COMMON STOCKHOLDERS
VOTE “FOR” PROPOSAL NO. 3 TO APPROVE THE AMENDMENT TO THE ANGION AMENDED AND RESTATED CERTIFICATE OF INCORPORATION PROVIDING FOR THE EXCULPATION OF OFFICERS.
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ELECTION OF DIRECTORS
At the Angion special meeting, Angion stockholders will vote on
the election of two directors to serve for a three-year term until the 2026 Annual Meeting of Stockholders. The Angion Board has unanimously nominated Itzhak Goldberg, M.D., F.A.C.R. and Allen R. Nissenson, M.D., whose terms of office expire in
2023, upon the recommendation of Angion’s nominating and corporate governance committee for re-election to the Angion Board as Class II directors. If elected at the special meeting, each nominee would serve until the Angion 2026 Annual Meeting
of Stockholders special meeting and until his successor has been duly elected and qualified, or, if sooner, until the director’s death, resignation or removal. The nominees have indicated that they are willing and able to continue to serve as
directors. If any nominee becomes unavailable for election as a result of an unexpected occurrence, shares that would have been voted for the nominee will instead be voted for the election of a substitute nominee proposed by Angion. It is
Angion’s policy to encourage directors and nominees for director to attend the Angion special meeting.
Angion stockholders should understand, however, that if the Merger
with Elicio is completed, the effect of the approval of Proposal No. 4 will be limited since the composition of the Angion Board will be reconstituted upon completion of the Merger, in accordance with the Merger Agreement. Pursuant to the
Merger Agreement, Angion is entitled to nominate three members to the combined company board of directors. Angion has previously nominated Jay Venkatesan, M.D., Karen J. Wilson and Allen R. Nissenson, M.D. to continue as directors of the
combined company board of directors if the Merger with Elicio is completed.
The Class II directors will be elected by a plurality of the
affirmative votes cast in person or by proxy and entitled to vote on the election of directors at the Angion special meeting. Accordingly, the two nominees receiving the highest number of affirmative votes will be elected. Stockholders do not
have cumulative voting rights in the election of directors. If you “WITHHOLD” authority to vote with respect to one or both of the director nominees, your vote will have no effect on the election of such
nominees. Broker non-votes will have no effect on the election of nominees.
Unless otherwise instructed, it is the intention of the persons
named in the accompanying proxy card to vote shares represented by properly executed proxy cards “FOR” the election of each of Itzhak Goldberg, M.D., F.A.C.R. and Allen R. Nissenson, M.D.
THE ANGION BOARD RECOMMENDS A VOTE “FOR” THE ELECTION OF EACH OF
ITZHAK GOLDBERG, M.D., F.A C.R. AND ALLEN R. NISSENSON, M.D. AS CLASS II DIRECTORS PURSUANT TO THIS DIRECTOR ELECTION PROPOSAL.
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RATIFICATION OF SELECTION OF ACCOUNTING FIRM
The Audit Committee of the Angion Board has selected Moss Adams
LLP as Angion’s independent registered public accounting firm for the fiscal year ending December 31, 2023 and has further directed that management submit the selection of its independent registered public accounting firm for ratification by
the stockholders at the Angion special meeting. Moss Adams LLP has audited Angion’s financial statements since 2018. Representatives of Moss Adams LLP are expected to attend the Angion special meeting. They will have an opportunity to make a
statement if they so desire and will be available to respond to appropriate questions.
Neither Angion’s Bylaws nor other governing documents or law
require stockholder ratification of the selection of Moss Adams LLP as Angion’s independent registered public accounting firm. However, the Audit Committee of the Angion Board is submitting the selection of Moss Adams LLP to the stockholders
for ratification as a matter of good corporate practice. If the stockholders fail to ratify the selection, the Audit Committee of the Angion Board will reconsider whether or not to retain that firm. Even if the selection is ratified, the Audit
Committee of the Angion Board in its discretion may direct the appointment of different independent auditors at any time during the year if they determine that such a change would be in the best interests of Angion and its stockholders.
The affirmative vote of the holders of a majority of the shares
present in person or virtually or represented by proxy and entitled to vote on the matter at the Angion special meeting will be required to ratify the selection of Moss Adams LLP.
The following table sets forth all fees billed for professional
audit, tax and other services rendered by Moss Adams LLP (in thousands):
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Year Ended December 31,
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2022
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2021
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Audit Fees(1)
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$497
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$408
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Tax Fees(2)
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33
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22
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Other(3)
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29
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31
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Total Fees
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$559
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$461
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(1)
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Audit fees are for professional services for the audit of Angion's financial statements, the review of quarterly interim
financial statements, and for services that are normally provided by the accountant in connection with other regulatory filings or engagements. Fees for the year ended December 31, 2022 include services associated with our S-3, S-4 and
S-8 filings. Fees for the year ended December 31, 2021 include services associated with our IPO and services rendered for the 2021 audit.
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(2)
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Tax fees are for compliance and consultation.
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(3)
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Other fees are for admin fees and grant compliance audit fees.
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The Audit Committee has adopted a policy and procedures for the
pre-approval of audit and non-audit services rendered by Angion’s independent registered public accounting firm, Moss Adams LLP. The policy generally pre-approves specified services in the defined categories of audit services, audit-related
services and tax services up to specified amounts. Pre-approval may also be given as part of the Audit Committee’s approval of the scope of the engagement of the independent auditor or on an individual, explicit, case-by-case basis before the
independent auditor is engaged to provide each service. The pre-approval of services may be delegated to one or more of the Audit Committee’s members, but the decision must be reported to the full Audit Committee at its next scheduled meeting.
The Audit Committee has determined the rendering of services other
than audit services by Moss Adams LLP is compatible with maintaining the principal accountant’s independence.
The affirmative vote of a majority of the votes cast virtually or
by proxy at the Angion special meeting is required to approve Proposal No. 5. Abstentions and broker non-votes will have no effect on the outcome of this
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proposal. It is anticipated that Proposal No. 5 will be a discretionary proposal
considered routine under the rules of the NYSE, which generally controls the ability of brokers to vote or not vote shares held in street name on certain matters, and thus may not result in broker non-votes.
THE ANGION BOARD RECOMMENDS THAT THE ANGION STOCKHOLDERS VOTE
“FOR” PROPOSAL NO. 5 TO RATIFY THE SELECTION OF MOSS ADAMS LLP AS ANGION’S INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM FOR THE FISCAL YEAR ENDING DECEMBER 31, 2023.
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APPROVAL OF POSSIBLE ADJOURNMENT OF THE ANGION SPECIAL MEETING
If Angion fails to receive a sufficient number of votes to approve
the Stock Issuance Proposal and/or the Reverse Stock Split Proposal, Angion may propose to adjourn the Angion special meeting for the purpose of soliciting additional proxies to approve the Stock Issuance Proposal and/or the Reverse Stock Split
Proposal. Angion currently does not intend to propose adjournment at the Angion special meeting if there are sufficient votes to approve the Stock Issuance Proposal and the Reverse Stock Split Proposal.
If on the date of the Angion special meeting, or a date preceding
the date on which the Angion special meeting is scheduled, Angion reasonably believes that (i) it will not receive proxies sufficient to obtain the required vote to approve the Angion Proposals, whether or not a quorum would be present or
(ii) it will not have sufficient shares of Angion common stock represented (whether in person or by proxy) to constitute a quorum necessary to conduct the business of the Angion special meeting, Angion may postpone or adjourn, or make one or
more successive postponements or adjournments of, the Angion special meeting as long as the date of the Angion special meeting is not postponed or adjourned more than an aggregate of 30 calendar days in connection with any postponements or
adjournments.
The affirmative vote of the holders of a majority of the shares of
Angion common stock properly cast at the Angion special meeting is required for approval of this proposal is required to approve the adjournment, if necessary, of the Angion special meeting for the purpose of soliciting additional proxies to
approve the Stock Issuance Proposal and/or the Reverse Stock Split Proposal.
The affirmative vote of a majority of the votes cast virtually or
by proxy at the Angion special meeting is required to approve Proposal No. 6. Abstentions and broker non-votes will have no effect on the outcome of this Proposal. It is anticipated that Proposal No. 6 will be a non-discretionary proposal
considered non-routine under the rules of the NYSE, which generally controls the ability of brokers to vote or not vote shares held in street name on certain matters, and thus may result in broker non-votes.
THE ANGION BOARD UNANIMOUSLY RECOMMENDS THAT ANGION STOCKHOLDERS
VOTE “FOR” THE ADJOURNMENT PROPOSAL TO ADJOURN THE SPECIAL MEETING, IF NECESSARY, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF THE STOCK ISSUANCE PROPOSAL AND/OR THE REVERSE STOCK SPLIT PROPOSAL.
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7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
Angion had been a clinical-stage biopharmaceutical company focused
on the discovery, development, and commercialization of novel small molecule therapeutics to address chronic and progressive fibrotic diseases, prior to Angion’s 2022 Strategic Realignment. Angion’s goal was to transform the treatment paradigm
for patients suffering from these potentially life-threatening conditions for which there are no approved medicines or where existing approved medicines have known limitations. Angion’s product candidates and programs included ANG-3070, a TKI
formerly in development as a treatment for fibrotic diseases; a ROCK2 preclinical program targeted towards the treatment of fibrotic diseases; a CYP11B2 preclinical program targeted towards diseases related to aldosterone synthase
dysregulation; and a CYP26 (retinoic acid metabolism) inhibitor program targeted towards a number of indications, including cancer; and ANG-3777, a hepatocyte growth factor (HGF) mimetic. If Angion does not complete the merger transaction with
Elicio, Angion could move forward with developing ANG-3070 and conducting further preclinical studies for its ROCK2 program.
On January 17, 2023, Angion announced it had entered into a
definitive merger agreement with Elicio under which Elicio will merge with a wholly-owned subsidiary of Angion in an all-stock transaction. Upon completion of the Merger, the combined company will focus on advancing Elicio’s proprietary lymph
node AMP technology to develop immunotherapies, with a focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors.
Angion 2022 Strategic Realignment was announced following the
Angion’s June 2022 termination of its Phase 2 “JUNIPER” dose-finding trial for ANG-3070 in patients with primary proteinuric kidney diseases, specifically focal segmental glomerulorsclerosis (FSGS) and immunoglobulin A nephropathy (IgAN). The
JUNIPER trial was terminated in the interests of patient safety based upon a reassessment of the risk/benefit profile of ANG-3070 in patients with established serious kidney disease. Angion completed the data collection work necessary related
to the JUNIPER trial to ascertain whether the drug had any effect, positive or negative, in patients with fibrotic kidney diseases and determined there was no economically-viable path forward for ANG-3070 in primary proteinuric kidney diseases.
ANG-3070
Prior to the termination of the Phase 2 study, Angion had been
focused on developing ANG-3070 in for fibrotic diseases in the kidney and lung. Angion continues to believe that, notwithstanding the termination of the ANG-3070 program in kidney indication, ANG-3070 could be a viable development candidate in
lung indications, such as idiopathic pulmonary fibrosis (IPF).
Pulmonary fibrosis is characterized by progressive scarring
(fibrosis) of the lungs, which leads to their deterioration and destruction. Over time, patients’ lung scarring progresses and breathing becomes difficult, often resulting in the lungs failing to take in enough oxygen to meet the body’s needs.
IPF is an aggressive form of pulmonary fibrosis with a median
survival of two to three years from diagnosis. The course of the disease is highly variable. Certain patients become seriously ill within a few months, while others may survive for five years or longer. Most deaths in IPF occur from progression
of pulmonary fibrosis leading to respiratory failure. According to the National Institutes of Health (NIH), approximately 140,000 people in the United States have IPF, and approximately 30,000 to 40,000 new cases are diagnosed each year,
usually affecting people between the ages of 50 to 70. EU incidence rates are estimated to be similar. Over half are undiagnosed in the mild category alone, while more could be underdiagnosed. The disease is of unknown cause and represents an
important area of unmet medical need.
There are currently two approved therapies for IPF, pirfenidone
(Esbriet®, sold by Roche/Genentech) and the kinase inhibitor nintedanib (OFEV®, sold by Boehringer-Ingelheim). Nintedanib is also approved for Scleroderma-associated interstitial lung disease (SSc-ILD) patients. Both drugs have known
tolerability challenges for patients. Diarrhea and nausea are very common side effects, with 62% of patients taking nintedanib reporting diarrhea and
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29% reporting nausea according to its drug label. Similarly, diarrhea was reported
by 26% and nausea by 36% of patients taking pirfenidone according to its label. Patient convenience is also a recognized challenge, with nintedanib required to be dosed twice per day with food and pirfenidone three times per day with food after
a three-step titration over the first two weeks. Patient drop-out rates for both drugs are substantial, with 43.8% of patients on nintedanib and 51.5% of patients on pirfenidone dropping out after 12 months. Neither therapy demonstrated an
impact on patient survival in the clinical trials forming the basis for their approval. Due to the recognized limitations of these approved medicines, under 30% of U.S. patients diagnosed with IPF, despite it being a life-threatening disease,
are prescribed nintedanib or pirfenidone.
Despite these drawbacks to tolerability, convenience, and
efficacy, pirfenidone and nintedanib generated approximately $3.8 billion in combined 2021 worldwide sales. If Angion is able to demonstrate in clinical trials ANG-3070 provides IPF patients with an alternative treatment option with a more
acceptable tolerability, convenience, and/or efficacy profile, Angion would expect ANG-3070, if approved, to compete successfully with these two approved medicines. However, there is no guarantee ANG-3070 will be able to achieve these goals or,
if it does, generate comparable revenues.
The next steps for the ANG-3070 program would be additional
preclinical and/or clinical work to confirm target engagement and dose levels in patients with IPF. In anticipation of the announced merger, however, Angion suspended the advancement of ANG-3070 in preclinical or clinical studies. Absent
completion of the transaction with Elicio, Angion could move forward with this program. Angion holds global rights to the ANG-3070 program.
ANG-3777
In 2022, Angion completed preclinical work and the process of
closing out analyses of data from the 2021 clinical trial readouts of ANG-3777, that was formerly its lead product candidate until December 2021. Angion has shared these data with its license partner Vifor International, Ltd, (Vifor Pharma) and
conversations continue on next steps for the program, if any. Angion does not intend to continue the clinical development plan for ANG-3777 set forth in the Vifor License, which had included a Phase 3 study for the prevention of AKI in patients
undergoing cardiac surgery involving CSA-AKI and a Phase 4 confirmatory study in donor kidney transplant patients who were at risk for developing DGF, given Angion does not believe the earlier Phase 2 and Phase 3 clinical trial results in the
respective indications support regulatory approval.
ROCK2, CYP11B2 and CYP26
During 2022, Angion also conducted activities in its ROCK2, CYP11B2
and CYP26 preclinical programs.
ROCK2
Angion’s ROCK2 program includes a number of highly selective, oral
small molecule inhibitors of ROCK2 developed internally as a potential treatment for fibrotic and other diseases. Over the past year, additional chemistry work at Angion resulted in additional libraries
of ROCK (Rho-associated coiled-coil forming protein kinase)-targeting compounds with differing ratios of ROCK2 and ROCK1 selectivity ranging from 300-fold to 1,600-fold selectivity for ROCK2 versus ROCK1 with promising bioavailability.
ROCK signal transduction pathways are implicated in the
development of fibrosis. Inhibition of ROCK isoforms ROCK1 and ROCK2 have shown promise in fibrosis and cardiovascular remodeling diseases. However, ROCK1 inhibition has been associated with hypotension (low blood pressure) and enhanced
vascular permeability.
Recent scientific work using specific genetic or pharmacological
reduction of ROCK2 indicates ROCK2 inhibition by itself can result in anti-fibrotic activity without causing hypotension. These findings informed Angion’s strategy to develop a ROCK2-specific inhibitor, with the goal of minimizing ROCK1
inhibition, as a potential treatment for fibrosis and other diseases. Angion believes this approach could translate into product candidates with enhanced tolerability potentially supporting long-term systemic use.
Multiple dual ROCK1/2 inhibitors have received regulatory
approval, including ripasudil (Glanatec®), which is approved in Japan for treating glaucoma and ocular hypertension, fasudil (ErilTM), which is approved in Japan and China for treating cerebral vasospasm in hemorrhagic stroke, and netarsudil
(Rhopressa®), which is approved in the United States for the treatment of glaucoma. The ROCK2-selective inhibitor belumosudil has been approved by the FDA for the treatment of chronic graft-versus-host disease.
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Elevated expression of ROCK2 has been implicated in a number of
chronic fibrotic conditions and other diseases. ROCK2 is significantly upregulated in fibrotic kidneys in both pediatric and adult patients, with ROCK2 levels positively correlated with the severity of the fibrosis. Study of ROCK2 inhibition in
the unilateral ureteral obstruction (UUO) model of renal fibrosis showed ROCK2 inhibition alleviates renal fibrosis. Furthermore, in a mouse model of IPF, researchers found mice with either ROCK1 or ROCK2 genetically deleted were protected from
bleomycin-induced IPF, indicating specifically targeting either ROCK isoform would be an effective therapeutic strategy against IPF. ROCK2 expression in vitro has also been associated with co-expression of fibrotic liver markers. Elevated ROCK2
levels are seen in cardiac hypertrophy, cardiac fibrosis and diastolic dysfunction. ROCK2 has also been shown to play a role in neurodegenerative disorders such as amyotrophic lateral sclerosis, Parkinson's disease and Alzheimer's disease. As a
result, Angion believes a potent ROCK2 inhibitor should prevent disease progression in chronic fibrotic diseases and potentially be useful in a variety of other cardiac and neurodegenerative disorders.
Dual ROCK1/2 inhibitors can have problematic side effects
including hypotension and increased vascular permeability. In an in vitro analysis measuring binding affinity for ROCK2 and ROCK1, Angion's ROCK2 selective inhibitors show much stronger binding affinity for ROCK2 versus ROCK1. Angion believes
high selectivity for ROCK2 could provide enhanced tolerability, potentially supporting long-term systemic use.
Angion holds global rights to its ROCK2 inhibitor program. Angion
has completed certain discovery and preclinical activities in its ROCK2 Program, and absent completion of the announced merger, Angion could move forward with this program, which is also currently available for out-licensing. Given the early
stage of the program, prior to a lead candidate being selected, investors should not expect any significant funds would be generated from a transaction, or even such a transaction occurring.
CYP11B2
Angion created a selection of inhibitor molecules with high
specificity to CYP11B2 (aldosterone synthase) relative to CYP11B1, which it was investigating for the purpose of targeting aldosterone-related diseases including resistant hypertension, congestive heart
failure, renal fibrosis, and primary hyperaldosteronism.
Aldosterone is a hormone produced in the adrenal glands which
helps control the body's blood pressure by causing the kidneys to retain salt and excrete potassium, thereby increasing water retention, blood volume and blood pressure. CYP11B2 is a member of the broad cytochrome P450 family and is responsible
for the biosynthesis of aldosterone. There are a number of diseases associated with dysregulated aldosterone, including primary hyperaldosteronism (Conn's Syndrome), refractory hypertension, congestive heart failure and kidney fibrosis. As a
result, Angion believes inhibition of CYP11B2 could potentially be used in aldosterone-related diseases. Angion has determined not to proceed with this program.
CYP26
Angion also worked on a CYP26 (retinoic acid metabolism) inhibitor
program targeted towards a number of indications, including cancer. The CYP26 program focuses on selective and potent inhibitors of CYP26, which is responsible for the degradation of retinoic acid. Retinoic acid, primarily in the form of ATRA
(all-trans retinoic acid) has been used both topically and systemically to treat conditions including acne, acyte promyelocytic leukemia, and photoaging. In a variety of animal models, Angion demonstrated CYP26 inhibition can increase retinoic
acid levels in target tissue while reducing systemic exposure of retinoic acid. Angion holds global rights to Angion's CYP26 inhibitor program. Angion has determined not to proceed with this program, other than under its exclusive license
agreement with Ohr Cosmetics LLC.
Angion has relied on third-party contract manufacturing
organizations to manufacture and supply product candidates for its clinical trials. Currently, Angion has agreements with a single third-party contract manufacturer to supply the drug substance for ANG-3070 and with a single third-party
contract manufacturer to manufacture all clinical trial supplies of ANG-3070. Currently, Angion believes it has sufficient inventory of ANG 3070 to meet the immediate requirements of potential future clinical trials, which may be conducted,
absent the completion of the announced merger.
The biotechnology and pharmaceutical industries are characterized
by intense competition and rapid innovation. Angion’s potential competitors include major multinational pharmaceutical companies, established biotechnology
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companies, specialty pharmaceutical companies and universities and other research
institutions. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Angion believes the key competitive factors affecting the
development and commercial success of its product candidates will be whether or not such product candidates are deemed to be safe and effective by relevant regulatory authorities, as well as their tolerability profile, reliability, convenience
of dosing, price, and reimbursement. Absent the completion of the announced merger, Angion could face significant competition on its ANG-3070 program for IPF from both approved therapies such as pirfenidone (Esbriet®, sold by Roche/Genentech)
for IPF and nintedanib (OFEV®, sold by Boehringer-Ingleheim) and from product candidates in development for IPF, such as PLN-74809 from Pliant Therapeutics for IPF , BI 1015550 from Boehringer Ingelheim, pamrevlumab from Fibrogen, and other
companies. Angion would also face competition for its ROCK2 program from Kadmon Holdings, Inc.'s belumosudil (KD025) and RXC007/RXC008 from Redx Pharma as well as other companies developing ROCK inhibitors.
The proprietary nature of, and protection for, Angion’s product
candidates, processes and know-how are important to its business. Angion pursues various avenues of intellectual property protection, including consideration of patent, trademark, and trade secret strategies. Angion has sought patent protection
in the United States and internationally for its programs relating to small molecule compounds with its tyrosine kinase inhibitors (including ANG-3070), HGF-like activity (including ANG-3777), its ROCK2 inhibitors and its CYP inhibitors.
Angion’s patent strategy seeks to protect its product candidates by filing patent applications, in the United States and in relevant foreign jurisdictions, and Angion pursues multi-faceted protection, as available, for example to relevant small
molecule compounds and analogs, pharmaceutical compositions and related methods of manufacture and use. Angion’s policy is to pursue, maintain and defend patent rights in order to protect the technology, inventions and improvements that are
commercially important to its business. Angion also relies on trade secret protection for certain intellectual property that may be important to the development of its business and expect to pursue trademark registrations for brand names or
other text or images that may provide commercial value.
In the United States and worldwide, issued patents have a
presumptive term, assuming all maintenance fees are paid, of twenty years from their earliest non-provisional filing date. Certain jurisdictions offer opportunities to extend this term. For example, the U.S. Patent and Trademark Office (USPTO)
may add term to a patent (referred to as Patent Term Adjustment) if delays by the USPTO of certain activities exceed prespecified durations, from which delays by the Applicant are subtracted. Additionally, many jurisdictions, including the
United States and Europe, provide opportunities for extending the term of patents relating to approved pharmaceutical products or their approved uses. In the United States, a single patent can be extended per approved product, for a period
(referred to as Patent Term Extension) of up to five years, depending on the dates of patent issuance relative to submission of an application for premarketing approval (i.e., of a NDA or a BLA) under provisions of the Drug Price Competition
and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act. Similar restoration of term is available in Europe under so-called Supplementary Protection Certificate rights, and extensions under similar policies may be available
in other countries.
Depending upon the timing, duration and specifics of FDA marketing
approval of Angion’s product candidates, if any, one or more of its patents may be eligible for limited Patent Term Extension under the Hatch-Waxman Act in the United States, Supplementary Protection Certificate in Europe.
Angion’s commercial success will depend in part on obtaining and
maintaining patent protection and/or other intellectual property protection for its current and future product candidates, including for their use, production, formulation, etc., with commercially relevant terms; Angion's commercial success may
also depend in part on Angion’s ability to successfully defend its patent and/or other intellectual property rights against third-party challenges. Angion’s ability to stop third parties from making, using, selling, offering to sell and/or
importing our products may depend on the extent to which it has rights under valid and enforceable intellectual property rights that cover these activities. Angion cannot be sure that patents will be granted with respect to any of its pending
patent applications or with respect to any patent applications filed by it in the future, nor can Angion be sure that any of its existing patents or any patents that may be granted to it in the future will be commercially useful in protecting
its product candidates, discovery programs and processes. Additionally, Angion cannot be certain that it will always be able to establish sufficient ownership rights to ensure complete or necessary control over its intellectual property
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rights as required in order to obtain, maintain, and/or enforce them. The
expiration dates of the patents discussed below assume in all cases that the appropriate maintenance, renewal, annuity, or other governmental fees are paid to maintain the patent(s) in force for the full extent of their term and any
extension(s) thereof.
Angion’s ANG-3070 Tyrosine Kinase Inhibitor
Program
As of March 17, 2023, compound, pharmaceutical composition and
methods of use claims to Angion's kinase inhibitors are covered in patents issued in the United States. Angion also owned issued patents in Australia, Canada, China, Europe, Hong Kong, Israel, India, and Japan. The European patent was validated
in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Monaco, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland/Liechtenstein, Turkey, and the United
Kingdom. A continuation application is pending in the United States. These patents, and patents that may issue from the pending applications, provide patent protection until 2033, assuming payment of all appropriate annuities and/or maintenance
fees.
As of March 17, 2023, Angion had filed applications directed to
the use of ANG-3070 in the treatment of irritable bowel disease (IBD) in Australia, Canada, China, Europe, Israel, Japan, and the United States. Patents issuing from corresponding national applications will expire in 2040.
As of March 17, 2023, Angion had filed applications in the United
States and Europe relating to solid forms of ANG-3070. Patents issuing from corresponding national applications will expire in 2041.
As of March 17, 2023, Angion had filed a PCT patent application
relating to gene expression levels associated with treatment comprising ANG-3070. Patents issuing from corresponding national applications, if granted, will expire in 2042.
Under the Hatch-Waxman Act, a single patent term restoration of up
to five years in the United States may be available. Angion also may be eligible for similar restoration of term in Europe under supplementary protection certificate rights, and similar extensions in certain other countries.
Angion’s ROCK2 Inhibitor Program
As of March 17, 2023, the patent portfolio for the ROCK2 inhibitor
program consists of three composition of matter patents. The first family includes granted patents in the United States and India, and pending applications in the United States, Australia, Canada, China, Europe, Hong Kong, Israel, and Japan,
each of which would have presumed twenty-year terms expiring in 2038. A second family includes pending applications in the United States, Australia, Canada, China, Europe, Israel, India, and Japan, each of which would have presumed twenty-year
terms expiring in 2040. A third family includes or will include pending applications in the United States, Canada, China, Europe, Israel, and Japan, each of which would have presumed twenty-year terms expiring in 2041.
Angion’s CYP11B2 Inhibitor Program
As of March 17, 2023, the patent portfolio for the CYP11B2
inhibitor program includes pending applications in the United States, Canada, Europe and Israel, each of which would have presumed twenty-year terms expiring in 2038. As of March 17, 2023, Angion owned issued patents in the United States that
claim, among other things, ANG-3598 composition of matter, pharmaceutical compositions comprising ANG-3598, and methods of treating renal fibrosis. Angion also owned issued patents in Australia, China, Israel, India and Japan. Each of the
patents expire in 2035.
Angion’s ANG-3777
As of March 17, 2023, the patent portfolio for ANG-3777 includes
patents and patent applications that describe and/or specifically claim pharmaceutical compositions whose active agent is ANG-3777 and uses thereof, as well as compounds structurally related to ANG-3777, pharmaceutical compositions and uses
thereof. As of March 17, 2023, Angion owned issued patents in the United States that claim, among other things, pharmaceutical compositions comprising ANG-3777. Angion also owned issued patents in Australia, Canada, China, Europe, Hong Kong,
Israel, and Japan. Granted European patents have been validated in the following European countries: Denmark, France, Germany, Hungary, Ireland, Italy, Luxembourg, Monaco, Netherlands, Sweden, Switzerland/Liechtenstein, and the United Kingdom.
These patents should remain in force, if the appropriate maintenance, renewal, annuity or other governmental fees are paid, in the United States until 2024, and in other jurisdictions until 2023.
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An aqueous formulation of ANG-3777 and analogues of sufficient
solubility for intravenous administration is the subject of claims in a patent issued in the United States that will expire in 2030 assuming continued payment of all maintenance fees.
Angion has issued United States patents on the use of ANG-3777 and
related compounds for the treatment of chronic obstructive pulmonary disease, (COPD), and scleroderma, which expire in 2028 and 2029, respectively.
Angion has issued patents in the United States to solid forms of
ANG-3777 which expire in 2040, and pending applications in Australia, Brazil, Canada, China, Israel, Japan, Korea, Mexico, New Zealand, Singapore, and the United States. Patents issuing from these applications will expire in 2040.
As of March 17, 2023, Angion has filed applications in the United
States and Europe directed to the use of ANG-3777 in the treatment of delayed graft function. Patents issuing from these applications will expire in 2040.
As of March 17, 2023, Angion has filed a PCT application directed
to methods of manufacturing ANG-3777 drug product. The presumptive twenty-year expiration of any national applications arising therefrom is 2041.
As of March 17, 2023, Angion has filed a PCT application directed
to methods of administering ANG-3777. The presumptive twenty-year expiration of any national applications arising therefrom is 2042.
As of March 17, 2023, Angion has filed a PCT application directed
to ANG-3777 prodrugs. The presumptive twenty-year expiration of any national applications arising therefrom is 2042.
Under the Hatch-Waxman Act, a single patent term restoration of up
to five years in the United States may be available. Angion also may be eligible for similar restoration of term in Europe under supplementary protection, certificate rights, and similar extensions in certain other countries.
License Agreement between Angion and Vifor Pharma
In November 2020, Angion granted Vifor Pharma, an exclusive,
global (excluding Greater China), royalty-bearing license (Vifor License), for the commercialization of ANG-3777 in all Renal Indications, beginning with DGF and CSA-AKI. The Vifor License also grants Vifor Pharma exclusive rights, with a right
to sublicense subject to Angion's consent for certain specified conditions, to develop and manufacture ANG-3777 for commercialization in Renal Indications worldwide (excluding Greater China) in cooperation with Angion or independently. Angion
retains the right to develop and commercialize combination therapy products combining ANG-3777 with its other proprietary molecules, subject to Vifor Pharma's right of first negotiation with respect to global (excluding Greater China) rights to
such combination therapy products in the Renal Indications. Although the Vifor License includes additional milestone and royalty objectives, Angion does not expect to receive any clinical, post-approval, or sales milestones, or royalties, as it
does not intend to continue to pursue the clinical development plan for ANG-3777, which had included a Phase 3 study for CSA-AKI and a phase 4 confirmatory study in DGF. Angion and Vifor continue to discuss the analyses of the results of the
clinical trials announced in the fourth quarter of 2021 and the future of the collaboration.
Collaboration between Angion and the University of
Michigan
In 2019, Angion entered into a subcontractor agreement with The
Regents of the University of Michigan (UM), under which it provided funding for identification of ANG-3070-responsive disease marker profiles in rodent models, and their intersection with existing data on patients with various forms of
nephrotic kidney disease, to identify potential ANG-3070-responsive patient subsets. Under this agreement Angion obtained access to the Nephrotic Syndrome Study Network (NEPTUNE), an integrated group of Academic centers, patient support
organizations, and clinical resources dedicated to advancing the treatment of kidney disorders. The goal of work under this agreement, which Angion supported through a grant from the U.S. Department of Defense, is to identify human disease and
drug response profiles based upon the genes, networks and pathways that correlate with the therapeutic activity of ANG-3070 in primary FSGS and other fibrotic renal diseases. Angion is obligated to provide to UM up to a total of $520,000 over
the course of the project. Angion has an option to license and commercialize intellectual property generated during the term of the agreement that is solely owned by UM under commercially reasonable terms. On March 21, 2022, Angion provided
written notice to UM of its intention to terminate the subcontractor agreement as Angion believes the work under the related U.S. Department of Defense grant to be complete. This agreement is now terminated.
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Collaboration between Angion and Ohr Cosmetics,
LLC
In November 2013, Angion granted Ohr an exclusive worldwide
license, with the right to sublicense, under Angion's patent rights covering one of its CYP26 inhibitors, for the use in treating conditions of the skin or hair. Sublicensees may not grant further sublicenses under Angion’s patent rights other
than to affiliates of such sublicensees and entities with which sublicensees are collaborating for the research, development, manufacture and commercialization of the products. Ohr will pay Angion a royalty at a rate in the low single digits on
gross revenue of products incorporating ANG-3522, and milestone payments potentially totaling up to $9.0 million based on achievement of sales milestones. Royalties and milestone payments will be paid until the later of 15 years from the first
commercial sale of a licensed product or the last to expire licensed patent rights. The royalty rate is subject to adjustments under certain circumstances. The Ohr License represents a related-party transaction, and Angion believes the Ohr
License was made on terms no less favorable to it than those Angion could obtain from unaffiliated third parties. On February 5, 2023, Angion and Ohr executed the First Amendment to the Ohr license agreement. Such amendment allows Ohr access to
Angion’s CYP26 inhibitors beyond ANG-3522 for the use in treating conditions of the skin and hair, eliminates Angion’s obligation to prosecute or maintain the patents rights licensed to Ohr at its principal expense, and allows Ohr to prosecute
and maintain such patent rights its sole own expense. No revenue from this license agreement was recognized in 2022 and 2021.
The FDA and other regulatory authorities at federal, state, and
local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, marketing and promotion, distribution, post-approval
monitoring and reporting, sampling, and import and export of drugs, such as those Angion is developing. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and
regulations require the expenditure of substantial time and financial resources.
U.S. Drug Regulation
In the United States, the FDA regulates drugs under the Federal
Food, Drug, and Cosmetic Act and its implementing regulations. FDA approval is required before any new drug can be marketed in the United States. Drugs are also subject to other federal, state and local statutes and regulations. Failure to
comply with applicable FDA or other requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA clinical holds, refusal to approve pending applications, withdrawal of an approval, warning or untitled
letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.
The process required by the FDA before product candidates may be
marketed in the United States generally involves the following:
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completion of preclinical laboratory tests and animal studies, all performed in accordance with the FDA's GLP regulations;
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submission to the FDA of an investigational new drug application (IND) which must become effective before human clinical
studies may begin and must be updated annually or when significant changes are made;
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approval by an IRB representing each clinical site before a clinical study may be initiated;
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performance of adequate and well-controlled human clinical trials in accordance with good clinical practice (GCP) regulations
to establish the safety and efficacy of the product candidate for each proposed indication;
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preparation of and submission to the FDA of an NDA;
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satisfactory completion of an FDA advisory committee review, if applicable;
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a determination by the FDA within 60 days of its receipt of an NDA to file the application for review;
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satisfactory completion of an FDA pre-approval inspection of the manufacturing facility(ies) where the product is
manufactured to assess compliance with cGMP regulations, and of selected clinical investigation sites to assess compliance with GCP; and
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FDA review and approval of an NDA to permit commercial marketing of the product for its particular labeled uses in the United
States.
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International Regulation
In addition to regulations in the United States, Angion could
become subject to a variety of foreign regulations regarding development, approval, commercial sales and distribution of Angion's products if it seeks to market its product candidates in other jurisdictions. Whether or not Angion obtains FDA
approval for a product, Angion must obtain the necessary approvals by the comparable regulatory authorities of foreign countries before it can commence clinical trials or marketing of the product in those countries. The approval process varies
from country to country and can involve additional product testing and additional review periods, and the time may be longer or shorter than that required to obtain FDA approval. The requirements governing, among other things, the conduct of
clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in
one country may negatively impact the regulatory process in others. If Angion fails to comply with applicable foreign regulatory requirements, Angion may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls,
seizure of products, operating restrictions and criminal prosecution.
As of December 31, 2022, Angion has three full-time employees and
nine part-time consultants.
Angion was incorporated in the State of Delaware on April 6, 1998.
Angion’s corporate headquarters are located at 7-57 Wells Avenue, Newton, Massachusetts 02459, and its telephone number is (857) 336-4001. Angion’s website address is www.angion.com. The information contained on, or that can be accessed
through, Angion’s website will not be deemed to be incorporated by reference into and does not constitute part of this filing.
Angion is subject to the information requirements of the Exchange
Act and therefore files its periodic reports, proxy statements and other information with the SEC relating to its business, financial statements and other matters. The SEC maintains an Internet site, www.sec.gov, that contains reports, proxy
statements and other information regarding issuers such as Angion.
For more information about Angion, including free access to its
annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports and other filings, visit Angion’s website, www.angion.com. The information found on or accessible through Angion’s website
is not incorporated into, and does not form a part of, this filing.
7-57 Wells Avenue, Newton, Massachusetts 02459
(857) 336-4001
Merger Sub is a wholly-owned subsidiary of Angion and was formed
solely for the purposes of carrying out the Merger. On January 17, 2023, Merger Sub entered into the Merger Agreement with Angion and Elicio. Pursuant to and subject to the terms and conditions of the Merger Agreement, Merger Sub will merge
with and into Elicio, with Elicio continuing as the surviving corporation and becoming a wholly-owned direct subsidiary of Angion. Merger Sub was formed on December 27, 2022 solely for the purpose of consummating the Merger. Merger Sub has not
carried on any activities to date, except for activities incidental to its formation and activities undertaken in connection with the Merger.
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Elicio is a clinical-stage biotechnology company pioneering the
development of therapeutic cancer vaccines for patients with limited treatment options and poor outcomes. Through its AMP platform technology, Elicio’s goal is to re-engineer the body’s immune response to defeat diseases using potent lymph node
targeted vaccines and immunotherapies.
Elicio’s proprietary AMP technology precisely traffics
immuno-modulatory molecules to the lymph nodes, the “schoolhouse” of the immune system, enhancing the magnitude, potency, functionality, and durability of the immune response. The lymph nodes are a primary site in the body where most immune
cells are located. The lymph nodes are where the immune system naturally collects information about health and disease in order to orchestrate the mechanisms of immunity which protect us from pathogens and tumors. By efficiently targeting these
sites within the body we are taking advantage of the power and the unique biology of the lymph nodes to improve responses across a broad range of diseases. Elicio’s is utilizing its lymph-node targeting technology to build a pipeline of
therapeutic cancer vaccines, which will be the focus of Elicio. Other applications of the AMP technology, such as infectious disease vaccines and immune cell therapies, will be developed through partnerships.
Elicio’s core business is the development of therapeutic cancer
vaccines. ELI-002, its lead clinical program, is designed to stimulate an immune response against the KRAS mutations driving 25% of solid tumors. ELI-002 is currently AMPLIFY-201 in patients with mutant (m)KRAS-driven PDAC and CRC.
The ELI-002 program is planned to provide multiple potential
pathways to success, including enrolling a cohort of patients with PDAC or CRC in a planned Phase 1/2 study called “AMPLIFY-7P”. Also, subject to receipt of additional funding following the Merger, a clinical trial to study the combination of
ELI-002 + LIBTAYO® (cemiplimab, Regeneron’s FDA-approved anti-PD-1 therapy) is planned. Studies are also being considered in other solid tumors and where ELI-002 could target additional RAS isoforms, such as neuroblastoma ras (NRAS) and Harvey
rat sarcoma (HRAS), to further expand the addressable population for ELI-002. ELI-002 has the potential to be a universal, all-stage immunotherapeutic for treating and preventing mKRAS-driven cancers.
While past cancer vaccine efforts have struggled to induce a
sufficient immune response to drive meaningful clinical benefit to patients, ELI-002 is poised to overcome these historical challenges through three advances intended to induce potent antitumor immune activity:
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The first major advance is the smart trafficking of ELI-002 to the lymph nodes after subcutaneous administration, generating
tumor-targeted immune responses of increased magnitude, function, and durability.
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The second advance is the clinical innovation of administering ELI-002 in the adjuvant setting, where ELI-002 is given after
the patient has completed surgery and initial standard of care treatments to reduce the size and quantity of existing tumors and micrometastases. Using ELI-002 in the adjuvant setting is intended to maximize the number of
mKRAS-targeting immune cells relative to the number of tumor cells. This strategy provides the potential for ELI-002 to eliminate any remaining residual disease in order to give the patient a longer period of disease control.
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The third advance is the inclusion of seven mKRAS peptides allowing ELI-002 to be used in additional patient populations, as
well as offering the potential to target potential tumor-acquired escape mutations, thereby increasing the durability of responses to treatment.
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Through ELI-002, Elicio is exploring whether its lymph node
targeting technology can create effective therapeutics out of biologically validated targets that have previously failed to induce clinically meaningful immune responses. This can be done quickly and efficiently, minimizing the time and cost
for new target validation. Elicio is developing additional lymph node targeted therapeutic cancer vaccines using a similar approach to ELI-002, including ELI-007 for use in the treatment of mutant (v-raf murine sarcoma viral oncogene homolog
B1) BRAF-driven cancers and ELI-008 for use in the treatment of mutated Tumor protein p53 (TP53) expressing cancers. Examples of mutant BRAF-driven and TP53-expressing cancers include melanoma, CRC, and NSCLC.
Elicio is also committed to maximizing the potential value of the
AMP platform in non-core applications via collaboration and partnership opportunities. These non-core applications include immune cell therapy ‘AMP-lifiers’ which
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enhance the immunologic effects of T Cell Receptor (TCR) T cell and Chimeric
Antigen Receptor (CAR) T T cell therapeutics, infectious disease vaccines, and AMP adjuvants, including ELI-004 (AMP-CpG, a component of ELI-002), as well as a pipeline of “next generation” adjuvants in development. Continuing to expand a
network of academic, foundation, and biopharmaceutical collaborations and commercial partnerships to develop these other applications of the AMP platform could validate and create pipeline programs, potentially benefit a larger population of
patients and generate additional funding for Elicio.
Elicio is led by a team with extensive experience in
immuno-oncology, biologics, drug discovery platform technologies, clinical development, general management, financing, and business development transactions. Members of the management team have had extensive involvement in multiple mergers and
acquisitions deals, as well as several initial public offerings, follow-on offerings, and partnering deals.
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Elicio’s Chief Executive Officer, Robert Connelly, has more than 20 years of experience as a life sciences CEO. Prior to
joining Elicio, Mr. Connelly served as CEO of Axcella Health Inc., Pulmatrix, Inc., and Domantis Ltd. and also served as a Venture Partner at Flagship Pioneering.
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Elicio’s Chief Medical Officer, Christopher Haqq, M.D, Ph.D., is a medical oncologist with extensive experience, including
senior executive roles at Atara Biotherapeutics, Inc., Cougar Biotechnology, Inc., and Janssen Oncology, Inc., as well as an academic role at the University of California, San Francisco Division of Hematology and Oncology.
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Elicio’s interim Chief Financial Officer, Daniel Geffken, who also sits on the Elicio Board, has more than 30 years of
experiences in the life sciences industry. Mr. Geffken has served as CFO and strategic consultant to numerous companies, including Apellis Pharmaceuticals, Inc., Cidara Therapeutics, Inc., Cabaletta Bio, Inc., Homology Medicines, Inc.,
Stealth BioTherapeutics, LLC, and Transkaryotic Therapies, Inc.
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Elicio’s Chief Business Officer, Annette Matthies, Ph.D., has nearly 20 years of biotech experience in corporate strategy,
business development, new product planning, and private and public fund raising, including roles at eFFECTOR Therapeutics, Inc., Receptos, Inc., Abbott Laboratories Inc., Facet Biotech Corporation, and Biogen Inc.
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Elicio’s Chief Scientific Officer, Peter DeMuth, Ph.D., has over a decade of experience in oncology, immunology, and
materials science. He oversaw efforts to develop novel technologies for immunotherapy at the MIT Koch Institute for Integrative Cancer Research (Koch Institute), in affiliation with the Ragon Institute of Massachusetts General Hospital
(Ragon Institute)(MGH), MIT, and Harvard University, prior to joining Elicio as a founding scientist.
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Members of Elicio’s management team have contributed to product development programs that have received regulatory approval
and been successfully commercialized, including Abraxane®, Avastin®, Breyanzi®, Ebvallo™, Herceptin®, Rituxan®, Yondelis®, and Zytiga®.
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In addition to its strong leadership team, the expertise and
experience of Elicio’s scientific advisors positions it well to realize its goal of pioneering the development of therapeutic cancer vaccines for patients with limited treatment options and poor outcomes. Elicio’s scientific advisors offer
expert technical guidance to help shape Elicio’s scientific and strategic direction, while also raising Elicio’s profile lending it greater credibility and visibility in the biotechnology industry. While there are no formal rules or procedures
for the scientific advisory board, scientific advisors hold meetings throughout the year where they interact with appropriate members of the Elicio management team in real-time, lending expertise and guidance as needed. The members of the
scientific advisory board receive equity and cash compensation pursuant to consulting agreements with Elicio, however, Dr. Adams and Dr. Ruffolo only receive compensation for their service on the Elicio Board and do not receive additional
compensation for their role on the scientific advisory board.
Elicio’s scientific advisory board includes the following members:
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Darrell Irvine, Ph.D., Chairman of Elicio’s scientific advisory board, holds positions at the Koch Institute, the Ragon
Institute, and Harvard University, along with being a Howard Hughes Medical Institute Medical Fellow
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Julian Adams, Ph.D., Chairman of Elicio’s Board and retired Chief Executive Officer of Gamida Cell Ltd.
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Adrian Bot, M.D., Ph.D., Chief Scientific Officer and Executive Vice President, Research & Development at Capstan
Therapeutics, Inc. and formerly Head of Research at Kite Pharma, Inc.
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Emanuele Ostuni, Ph.D., former Head of Europe for Cell and Gene Therapies at Novartis Oncology.
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Robert R. Ruffolo, Ph.D., current member of Elicio’s Board and retired President of Research & Development at Wyeth, LLC.
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Pashtoon Kasi, M.D., M.S., Director Colon Cancer Research and Director PrecisionMed, LLC.
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Elicio’s AMP platform has broad potential across cancer,
infectious diseases, and other diseases. Among its development candidates, Elicio intends to internally advance ELI-002 for mutated RAS-driven cancers, and advance ELI-007 for mutant BRAF-driven cancers and ELI-008 for mutant TP53-expressing
cancers.
Elicio intends to advance additional applications of the AMP
platform via out-licensing, co-development, or other partnership arrangements. These other applications include immune cell therapy AMP-lifiers for both CAR T cell therapeutics (e.g., ELI-011 for
hematological cancers) and TCR T cell therapeutics (e.g., ELI-012 for mKRAS-driven solid tumors). Elicio has also completed preclinical proof-of-concept assessments related to the intranasal and
subcutaneous use of the AMP platform to prevent infectious diseases, including COVID-19. Finally, Elicio is advancing a pipeline of multiple ‘next-generation’ AMP adjuvants that can be applied with external vaccines, therapeutic or
prophylactic, including its lead adjuvant ELI-004, a component of ELI-002. Elicio’s most advanced development initiatives, their current stage of development, and the next anticipated major milestone for each program are presented in the chart
below.
Elicio's Development Pipeline
Elicio is re-engineering the body’s immune response to defeat
cancer and infectious diseases with potent lymph node targeted immunotherapies and vaccines. To achieve this, Elicio intends to:
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Rapidly advance its lead mutant KRAS-targeted program, ELI-002, which is designed to address approximately 25% of all solid
tumors.
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Augment the ELI-002 program through external collaborations that combine ELI-002 with complementary mechanisms to provide
greater benefit and expand the treatable population, as in its supply agreement with Regeneron.
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Develop its pipeline of therapeutic cancer vaccines to follow ELI-002, including ELI-007 for mutant BRAF-driven cancers and
ELI-008 for mutant TP53-expressing cancers, and continue to identify additional biologically validated but hard-to-drug targets that can be “activated” through lymph node engagement.
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Create economic and strategic value through licensing and partnerships for other applications of the AMP platform including
cell therapy AMP-lifiers, infectious disease vaccines, and AMP adjuvants.
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Continue to build out and expand upon applications of the AMP platform to capitalize on the potential of the technology and
significant breadth of product opportunities available.
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Elicio’s focus on the AMP platform technology is founded upon an
intimate appreciation of the lymphatic system’s critical involvement in the functioning of the human immune system. Elicio believes the therapeutic utility of currently approved immunotherapies is limited in many cases due to the inability of
those therapies to adequately engage with the critical immune cells resident in the lymph nodes responsible for stimulating adaptive immunity, including priming T cell activation, and promoting antibody responses. The AMP platform is
specifically intended to remedy this issue and the majority of Elicio’s product candidates, including ELI-002, has been constructed upon this central tenet. The relationship between the lymphatic and immune systems, and the significance of that
relationship for immunotherapy, is summarized below.
A primer on the adaptive immune system
The adaptive immune system is part of the human immune system and
is made up of B lymphocytes and T lymphocytes. B lymphocytes, also known as B cells, are involved in the humoral immune response, differentiating into antibody-secreting plasma cells on activation and recognition of a disease-specific molecular
structure known as an antigen. T lymphocytes, also known as T cells, participate primarily in the cell-mediated immune response and are capable of specific antigen-directed recognition and elimination of pathogenic threats.
T cells can be further segregated into distinct cell types, with
the primary types being CD8+ T cells, which are also referred to as cytotoxic lymphocytes (CTLs) and CD4+ “helper” T cells. CD8+ T cells specifically recognize and eliminate cells infected with viruses, other pathogens, or cancer-associated
mutations. In contrast, CD4+ T cells, which have limited cytotoxic activity, participate in the immune response by directing the activity of other cells, in particular B cells and CD8+ T cells.
Antigen presenting cells (APCs) are a functional class of immune
cells capable of taking up antigens by a variety of mechanisms and then processing and presenting them to lymphocytes for recognition by the adaptive immune system. Dendritic cells (DCs) are APCs particularly well suited to driving the adaptive
immune response through direct interaction with adaptive immune cells to modulate and support their function.
The lymphatic system and its key role in effective immune response
Lymph, a clear extracellular fluid, contains waste products and
cellular debris collected from peripheral tissues. The lymphatic system is a complex network of interconnected vessels, nodes, and organs through which lymph flows. One of its primary functions involves collecting and concentrating molecular
cues of health and disease for monitoring by the immune system.
The lymphatic system plays a major role in the production,
differentiation, and proliferation of both B cells and T cells, and the lymph nodes serve a critical role in lymphocyte activation and acquisition of essential functionality. As noted in the figure below, the lymph nodes act as the schoolhouse
of the immune system and play a key role in activating the immune system in response to detected threats from cancer and pathogens.
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Immune Response is Orchestrated in the Lymph Nodes
Lymph nodes are found throughout the body and are located on the
lymphatic vessels at various intervals along the lymphatic routes. During the process of circulating through the lymphatic system, lymph fluid accumulates antigens and other biomolecules captured from the tissues. This fluid then drains into
the lymph nodes, where it encounters T cells and B cells congregated together with APCs.
APCs and certain other immune cells contained in the lymph nodes
function to constantly sample the lymph fluid searching for signs of potential threats within the body. APCs serve as sentinels to orient the cells of the adaptive immune response to develop a properly targeted and functional protective
response by presenting these cues to B cells, T cells, and other immune cells within the lymph nodes. The activation of B cells and T cells with proper specificity and functionality marks the genesis of the adaptive immune response whereby
numerous disease-specific and functionally-matured lymphocytes are expanded and deployed.
After sufficient interaction with APCs within the lymph nodes,
these activated B cells and T cells exit the lymph nodes and eventually enter the bloodstream, which distributes them throughout the body to accumulate at disease sites or other lymphoid organs. Critically, signaling delivered between immune
cells residing in the lymph nodes orchestrates the immune response to determine the magnitude, potency, persistence, functionality, specificity, and memory capacity of the developing response.
Many vaccine components and other small molecules manufactured to
help enhance the immune response against disease unfortunately easily pass through the blood vessel walls at the site of injection and are quickly flushed away into the systemic circulation without entering into or engaging within lymph nodes.
In consequence, these conventional antigens and immunomodulators are not readily detected by APCs, B cells, or T cells resident in the lymph nodes and fail to optimally stimulate immune responses, which in turn reduces their efficacy in
eliminating disease. Larger molecules, such as proteins, on the other hand, are unable to fit through the pores lining small blood vessels in the tissues and are instead carried away from the tissues by the lymph flow into the lymph nodes.
Elicio believes the improved delivery to the lymph nodes inherent
with larger molecules holds great promise for enhanced immunological responses and therapeutic efficacy. Elicio’s AMP platform is designed to use this ability of larger molecules to deliver therapeutic payloads of interest to the lymphatic
system.
The left side of the figure below shows how vaccines, and some
immunotherapies, rapidly enter the bloodstream after injection into tissues and circulate to sites that are either immunologically insignificant or tolerogenic, hindering their ability to effectively activate immune cells or increasing
accumulation in areas where the immune response is suppressed. The right side shows the distribution of the agents is controlled by their molecular size. Smaller molecules tend to be distributed more substantially by blood vessels to irrelevant
sites, while larger molecules like protein albumin are effectively collected by lymph vessels and concentrate in lymph nodes.
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AMP Reprograms Biodistribution to Promote Targeted Delivery
of Payloads (e.g., Antigens, Adjuvants) to Lymph Nodes
Immunotherapy and limitations of current therapies
Immunotherapy is a treatment intending to harness the components
and mechanics of the immune system to address diseases and disorders. All current immunotherapy modalities, including efforts to develop robust therapeutic cancer vaccines, have inherent limitations with respect to their efficacy. While general
immune activity directed at target antigens has been observed with cancer vaccines during clinical evaluation, reduction in tumor loads has not been frequently noted. Contributing to this lack of efficacy is the low immunogenicity of
tumor-associated antigens (TAAs), down regulation of antigen presentation and processing mechanisms involving T cell recognition of tumor cells, especially in the late stage and advanced settings of disease, and the loss of adequate expression
of positive costimulatory signals. These negative factors result in limited generation of tumor antigen-specific T cells as well as impaired fitness of anti-tumor T cells.
Further complicating development efforts has been testing of these
cancer vaccines in patients with large advanced or metastatic solid tumors, where the number of tumor cells vastly exceeds the number and capacity of activated T cells to induce a commensurate response. This tumor environment is compounded by
the difficulties of T cell infiltration into the tumor microenvironment (TME) and mechanisms by which tumor cells evade detection by the immune system.
Other mKRAS-targeted therapeutic cancer vaccines have been studied
in humans. Elicio believes the results of these trials, though insufficient to result in regulatory approval due to shortcomings of these prior approaches, provide support for the use of a mKRAS-targeted therapeutic cancer vaccine. Further,
Elicio expects a lymph node targeting AMP construct to potentially generate additional efficacy through induction of a much stronger immune response compared to a non-lymph node targeted agent.
Another limitation of current immunotherapies Elicio believes
ELI-002 has the potential to address relates to immune checkpoint inhibitors (CPIs). CPIs have proven to be significant advances in cancer treatment. According to a January 2023 report from Allied Market Research, the global CPI market was
valued at $34.9 billion in 2021 and is forecast to reach $155.1 billion by 2031. CPIs require anti-tumor tumor infiltrating lymphocytes (TILs) in the tumor microenvironment to be effective. Patients whose tumors lack TILs are considered to have
“cold” tumors and typically fail to respond to treatment.
Elicio believes this can be addressed by its technologies enabling
the immune system to interact with tumor antigens inside the lymph node, where they can receive support from the natural stimulatory signals and cells unique to the specialized immune structure of the lymph node. Elicio conceives of this as a
schoolhouse for anti-tumor targeted therapy and believes such therapies can turn cold tumors “hot”, making them more amenable to treatment by CPIs.
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Elicio’s AMP platform has broad potential across cancer,
infectious diseases and other diseases. Among its development candidates, Elicio intends to internally advance ELI-002 for mutant RAS-driven cancers, ELI-007 for mutant BRAF-driven cancers, and ELI-008 for mutant TP53-expressing cancers.
Elicio intends to advance additional applications of the AMP
platform via out-licensing, co-development, or other partnership arrangements. These other applications include immune cell therapy AMP-lifiers for both CAR T cell therapeutics (e.g., ELI-011 for
hematological cancers) and TCR T cell therapeutics (e.g., ELI-012 for mKRAS-driven solid tumors). Elicio has also completed preclinical proof-of-concept assessments related to the intranasal and
subcutaneous use of the AMP platform to prevent infectious diseases, including COVID-19. Finally, Elicio is advancing a pipeline of multiple ‘next-generation’ AMP adjuvants that can be applied with external vaccines, therapeutic or
prophylactic, including its lead adjuvant ELI-004, a component of ELI-002.
ELI-002: Elicio’s Product Candidate for mutant KRAS-Driven Cancers
ELI-002 is a structurally novel AMP therapeutic vaccine targeting
mKRAS-driven cancers. KRAS mutations are among the most prevalent in human cancers. ELI-002 is comprised of AMP-modified mKRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide adjuvant.
Patients are treated with ELI-002 for a period of six months
during which they receive a “prime” series of subcutaneous injections, weekly for the first month and then every two weeks for the second month. After a 3-month rest period, the response is “boosted” with weekly doses of ELI-002 for another
month. This is analogous to many standard vaccination programs with the initial “prime” and later “boost” period.
Dosing & Administration for ELI-002
Background on the oncogene KRAS
The KRAS protein relays signals from outside of the cell membrane
to the cell nucleus. As such, it is an early component in many signal transduction pathways and influences the expression of downstream genes involved in the regulation of cell growth, cell differentiation, and cell death (also referred to as
apoptosis).
In normal physiology, guanosine diphosphate (GDP) preferentially
binds with KRAS. This molecular interaction results in KRAS remaining in an inactive state. KRAS transitions into an active state when stimulatory signals cause the replacement of GDP with guanosine triphosphate (GTP). Mutations to the KRAS
gene result in a bias towards active protein expression and unregulated and dysfunctional cell growth, which are hallmarks of cancer.
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Targeting mutated KRAS using immunotherapy presents several
potential advantages. First, mutated KRAS alleles are neoantigens, found exclusively in the tumor cells and not in normal tissues. This target specificity is thought to limit immune activity related to a potential on-target, but off-tumor,
response.
In addition, as a truncal mutation, KRAS is a genetic driver of
malignant changes across multiple cancers, causing a phenomenon known as “oncogene addiction,” where each tumor cell must maintain the expression of the target- mutated KRAS protein to remain viable. Such uniform expression across every
transformed cell in a particular tumor holds the promise that immunological approaches may enable complete tumor eradication. Further, because these mutations are neoantigens, they are not afforded immune tolerance. Therefore, the body’s
natural T cell repertoire is not depleted of high affinity antigen-specific T cell receptors, which are critical to a robust T cell-directed response.
KRAS mutations occur in exon 2, frequently at amino acid 12. G12D,
G12C, G12V, G12R, G12S, and G12A, along with G13D, are commonly responsible for oncogenic KRAS activation. The amino acids surrounding position 12 are identical across the three RAS isoforms (KRAS, HRAS, and NRAS) and can be targeted by
cross-reactive T cells. Different KRAS mutations may exhibit differing abilities to drive cancers originating in different tissues. For instance, the G12D mutation is commonly associated with gastrointestinal cancers, including pancreatic,
colorectal, bile duct, and gall bladder cancer, while the G12C mutation is more common to lung cancer.
While significant advances in the understanding of the genetic
mutations associated with mKRAS-driven cancers have been made, development of safe and efficacious therapeutics targeting KRAS mutations has lagged. While the anti-tumor activity of small molecule candidates specifically targeting the G12C
mutation such as sotorasib and sitravatinib have generated considerable enthusiasm in clinical trials involving NSCLC patients, the lack of a suitable binding site, together with the high binding affinity of GTP, have limited the ability to
successfully target other important KRAS mutations among the most common mutations in solid tumors, including those such as G12D, G12R, and G12V. Effective treatments for mKRAS-driven cancers remain a significant unmet medical need.
The figure below shows the seven KRAS driver mutations targeted by
ELI-002 are present in 25% of all solid tumors. In particular, 93% of PDAC and 52% of CRC tumors, those most prevalent in the AMPLIFY-201 study, are positive for KRAS mutations. Together, the addressable market opportunity for treating patients
with some or all of the seven KRAS mutations targeted by ELI-002 is measured in the billions of dollars.
ELI-002 may find therapeutic utility as a treatment for a variety
of cancers
While ELI-002 is initially being studied in patients with
mKRAS-driven PDAC, CRC, and NSCLC, there remains significant opportunity in additional mKRAS-driven cancers, as seen in the figure above. Other cancers with significant proportions of KRAS mutations include bile duct and ovarian cancers. In
addition to other cancer types, ELI-002 also has the ability to treat cancers with mutations at all three RAS isoforms including NRAS and HRAS, as well as KRAS, providing the potential to treat additional patient populations with unmet need in
cancers including bladder, gallbladder, and acute myeloid leukemia (AML).
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The results of Elicio’s preclinical studies have
provided evidence of ELI-002 activity against KRAS mutations
The results generated in a series of preclinical evaluations of
ELI-002 highlight the therapeutic potential of the AMP platform and have supported ELI-002’s advancement into clinical trials. Mice (n=5) were dosed with AMP-modified 18-mer peptide sequences of KRAS mutations, along with AMP-modified CpG, with
a second dose of the AMP-combination administered 14 days later, and the immune response generated by AMP constructs assessed after an additional seven days. Shown below are the results produced by AMP constructs specifically targeting the KRAS
G12D, G12R, and G12V mutations, compared to untreated animals and animals dosed with unmodified KRAS peptides plus either the CpG adjuvant or a polyI:C adjuvant. G12D, G12R, and G12V mutations are commonly associated with gastrointestinal
cancers. The data show the AMP-modified peptide sequences significantly boosted immune response compared to the non-modified sequences.
AMP-modified KRAS peptides generated strong immune responses
across a range of KRAS mutations
These studies demonstrate the ability of an AMP vaccine to produce
an enhanced immune response in mice with mean activity enhanced 40-fold compared to soluble G12V peptide plus soluble adjuvant, at least 60-fold compared to soluble G12R peptide plus adjuvant, and 400-fold compared to soluble G12D peptide plus
adjuvant.
These data suggest not only does the AMP platform produce more T
cells, but these T cells have improved functionality. The AMP-modified peptide/adjuvant combination’s ability to stimulate a strong immune response was demonstrated in additional studies evaluating the increase in cytokine levels generated by T
cells induced with AMP-modified G12D peptides. Mice were administered the AMP construct four times at two-week intervals, with cytokine levels measured at intervening periods. These cytokine levels were compared against levels detected in
T cells collected from untreated animals and after the administration of soluble peptide vaccines containing either soluble CpG or poly I:C adjuvant. As presented in the figure below, the AMP-modified peptides given with AMP-CpG generated
increases in cytokine production from antigen stimulated T cells compared to either the untreated animals or animals treated with soluble peptide and adjuvant, with increased cytokine activity most pronounced after administration of both prime
and boosting doses. Elicio believes this increase in cytokine activity is representative of the potency of an AMP-generated immune response and predictive of improvement to both T cell numbers and quality.
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A booster dose generated increases in cytokine activity
Importantly, as illustrated in the figure below, after dosing in
mice as described above, AMP-modified KRAS constructs promoted mKRAS-specific cytotoxic T cell function as evidenced by enhanced detection of granzyme production by T cells collected from AMP-vaccinated animals relative to comparators (p <
0.0001). In addition, when vaccinated mice were infused with mKRAS-pulsed target cells, only those who had received AMP vaccines were able to generate an mKRAS G12D-specific cytotoxic response (p < 0.0001). In these animals, ~50% of
mKRAS-target cells were eliminated over the course of 16 hours, while comparator vaccines were inactive. In vivo cytotoxic activity against solid tumor models in mice has not been evaluated and thus tumor immunosuppressive effects were not
assessed. As the reported studies were conducted in mice, the results described may not be applicable to solid tumors in humans.
AMP therapy induces cytotoxic T cell activity towards KRAS
mutations
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Further evaluation of escalating doses of AMP-CpG combined with
seven AMP-modified peptides (G12D, G12V, G12R, G12S, G12A, G12C, and G13D) in mice demonstrated induction of dose-dependent and consistent immune responses targeting all seven mKRAS epitopes. In the figure below, the higher the dose of
AMP-modified CpG the higher the immune response. These results demonstrate the ability of an AMP-modified vaccine to simultaneously generate multiple functional immune responses in mice specific to a variety of KRAS mutant forms.
AMP therapy induces strong immune responses targeting seven
common KRAS mutations
ELI-002 Clinical Development Program
The Phase 1 AMPLIFY-201 trial accelerated ELI-002 clinical
development with a 2-peptide (2P) formulation, which targets the two most common KRAS mutations, G12D and G12R. The AMPLIFY-7P Phase 1/2 study expects to transition ELI-002 development to the clinic-ready 7-peptide (7P) formulation in the first
half of 2023. In April 2022, Elicio received IND clearance from the FDA to commence AMPLIFY-7P, using the 7-peptide formulation of ELI-002. The IND submission package included all requisite preclinical and toxicology data for the 7-peptide
formulation.
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AMPLIFY-201: A Phase 1 clinical trial of ELI-002
Elicio is currently enrolling patients in AMPLIFY-201, a Phase 1
clinical trial of ELI-002 in patients with solid tumors, including CRC and PDAC. The AMPLIFY-201 trial is enrolling at eight cancer treatment institutions across the United States, including MD Anderson, where the first patient was dosed in
October 2021. Other trial sites include Memorial Sloan Kettering, Massachusetts General Hospital, City of Hope, Northwell Health and University of Colorado, University of California, Los Angeles, and University of Iowa. Following this initial
dose escalation trial, Elicio intends to expand patient eligibility to evaluate the potential of ELI-002 as a treatment for a number of KRAS-mutated cancers. The figure below depicts the AMPLIFY-201 protocol.
AMPLIFY-201 Protocol: 3+3 Dose Escalation Study with 2P Formulation
AMPLIFY-201 is configured as a Phase 1, U.S. multicenter, dose
escalation study intended to evaluate the safety and tolerability of ELI-002, as well as provide immunologic and anti-tumor proof of concept. Elicio is enrolling up to 30 patients who have completed surgery for removal of the tumor and received
standard of care treatment, yet remain positive for a biomarker indicating high relapse risk. The current standard of care for patients who remain positive for a biomarker following surgery and initial treatment is observation to monitor for
relapse, which has a near certain probability of occurring. In PDAC patients who have positive ctDNA post-surgery, relapse occurs in 80%–85% of cases despite ‘curative’ resection with a median time of 9.9 months to recurrence. In CRC patients
who have positive ctDNA post-surgery, radiologic recurrence was detected in ~79% of cases with a Kaplan Meier estimate of 0% survival at 3 years.
While past trials have evaluated immune therapy in advanced,
metastatic cancer, Elicio designed its trial for patients who have had prior surgery to remove the tumor and have only minimal tumor cells remaining. Elicio believes limiting enrollment to those patients allows it to maximize the ratio of T
cells to tumor cells (the so-called “effector to target” ratio), use ELI-002 in a window of opportunity where there is no suppression of T cell activity caused by other cancer treatments, and dose ELI-002 before the tumor may develop
immunosuppressive barriers. The novel design of the AMPLIFY-201 trial was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022.
PDAC and CRC patients represent the majority of patients enrolled
in the dose-escalation cohorts of the trial, though eligibility also includes several KRAS and NRAS mutation-related solid tumors such as NSCLC, ovarian cancer, and cancers of the bile duct and gallbladder.
AMPLIFY-201 employs investigational assays designed to detect
circulating tumor DNA (ctDNA) and serum tumor biomarkers to identify patients with KRAS mutations who show signs of minimal residual disease in their blood before relapse is detected in traditional radiographic scans. These assays allow for
rapid identification of the speed and magnitude of clinical antitumor response versus traditional survival endpoints to establish proof of concept. These assays will also be used to perform serial monitoring to assess the percentage of patients
achieving Minimal Residual Disease (MRD) clearance throughout the study.
The adjuvant stage is unique due to post-surgery limitations on
using radiographic endpoints such as RECIST and iRECIST. These endpoints also struggle to accurately measure the effects of immuno-oncology drugs, including unusual response patterns and pseudo-progression. Pseudo-progression occurs when immune
therapy temporarily increases the size of the tumor on scans, which may indicate tumor destruction by immune cells and not cancer growth. This can lead to incorrect assessment and treatment for patients. To overcome these limitations, the
AMPLIFY-201 trial uses serum tumor biomarkers (CA19-9 for pancreatic cancer, CEA for CRC) and ctDNA for quicker identification of ELI-002’s anti-tumor effects. These measures can be analyzed for kinetics and completeness,
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and compared to traditional endpoints such as overall survival and relapse-free
survival. Furthermore, patients with detectable tumor at baseline were excluded in the adjuvant population studied in AMPLIFY-201, making radiographic response measures even less useful for proof-of-concept.
Trial participants are enrolled into one of five progressive
open-label dose-escalating cohorts and are administered ELI-002 over six months divided into an eight-week immunization period, followed by a four-week booster period, separated by a three-month interval. After the ELI-002 treatment,
participants continue for an 18-month long-term follow-up period. Trial endpoints include safety, determination of maximum tolerated dose, ctDNA and/or serum tumor biomarker change from baseline, relapse free survival, and immunological
responses including cytokine activity and immune response and will be assessed throughout the 24 months of treatment and follow-up.
The Safety Review Committee cleared dose-escalating Cohorts 1
through 5. Elicio is close to the end of enrollment of the Phase 1 dose escalation in the AMPLIFY-201 clinical trial. ELI-002 dose escalation efficacy and safety data are anticipated to be presented at an upcoming medical conference in the
second quarter of 2023. Elicio intends to use this clinical experience to select the starting dose for the Phase 1/2 AMPLIFY-7P trial.
AMPLIFY-7P: A Phase 1/2 clinical trial of ELI-002
In April 2022, Elicio received Investigational New Drug (IND)
clearance from the FDA to commence AMPLIFY-7P, using the 7-peptide formulation of ELI-002. The Phase 1/2 AMPLIFY-7P trial is a U.S. multicenter study configured as an initial Phase 1a safety run-in of six to 12 patients to transition to the
7-peptide formulation and confirm the dose level established in AMPLIFY-201, followed by a Phase 1b dose expansion phase of three solid tumor cohorts in mKRAS-driven PDAC, CRC, and NSCLC, with each cohort enrolling between nine to 17 patients.
The Phase 1b dose expansion phase of the AMPLIFY-7P trial is
depicted in the figure below. Elicio anticipates initiating the Phase 1a safety run-in of AMPLIFY-7P in the first quarter of 2023.
AMPLIFY-7P: Phase 1a safety “run-in” and Phase 1b dose expansion
protocol
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After completion of the Phase 1 portion of the trial, and
subject to receipt of additional funding following the Merger, Elicio intends to conduct a multicenter Phase 2 study in PDAC patients, following R0 or R1 surgical resection. Elicio anticipates enrolling 93 patients in Phase 2, which will
compare the recommended dose to a patient cohort receiving observation, the SOC for these patients. Patients will be administered a series of immunization doses which will be followed by a series of booster doses, following the dosing schedule
of the Phase 1 trial. Patients enrolled in the observational SOC cohort will become eligible to crossover into the treatment cohort upon relapse. This proposed Phase 2 component of AMPLIFY 7P is shown in the figure below.
AMPLIFY-7P: Phase 2 Protocol
The primary endpoint of the Phase 2 portion will be relapse-free
survival (RFS), an endpoint that has supported regulatory approval in post-surgical patients. An example is the recent approval of Merck's pembrolizumab for post-surgical melanoma patients, which was based on RFS. Further secondary endpoints of
the Phase 2 portion will be clearance of ctDNA present at baseline, response rate for those patients who crossover from observation after relapse, and measurement of immunological responses. The ctDNA and serum tumor biomarker level endpoints
may provide Elicio early insight into clinical activity.
Elicio believes positive data may support FDA Fast Track or
Breakthrough Therapy designations, which are programs intended to facilitate and expedite development and review of new drug applications (NDA) for the treatment of a serious condition with unmet medical need. In addition, Elicio may be able to
qualify for orphan drug designations for the solid tumor patient populations it selects for clinical development.
If the results of the Phase 1b portion of the AMPLIFY-7P trial are
favorable and, subject to receipt of additional funding following the Merger, Elicio expects to continue to evaluate the use of ELI-002 in the treatment of PDAC in a randomized Phase 2 cohort. The Phase 1b expansions are expected to be
initiated in the second half of 2023, with the Phase 2 expected to be initiated in 2024.
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Anticipated data readouts and other milestones for the ELI-002
clinical program are represented in the figure below.
ELI-002 Clinical Program Milestone Projections:
Phase 1 Data Readout 2023 & Phase 2 Interim Assessment 2024
AMPLIFY-202 combination trial with Regeneron Pharmaceuticals, Inc’s
LIBTAYO® (cemiplimab)
In May 2022, Elicio entered into a clinical supply agreement with
Regeneron Pharmaceuticals, Inc. (Regeneron) to evaluate the safety and efficacy of ELI-002 in patients with mKRAS-driven tumors in combination with LIBTAYO®, an FDA approved fully human monoclonal antibody targeting the immune checkpoint
receptor PD-1 on T cells. The combination therapy will be studied in mutant KRAS-driven tumors including Stage III and IV NSCLC, Stage IV CRC and unresectable, locally advanced or oligometastatic PDAC.
This combination trial, called “AMPLIFY-202”, will be conducted by
Elicio and is expected to begin after the Phase 1a safety evaluation portion of AMPLIFY-7P completes, the manufacturing disposition has occurred, and subject to receipt of additional funding following the Merger. Each party will provide their
respective agent for the trial. Elicio retains full worldwide rights to ELI-002, Regeneron has no rights, and the agreement does not restrict Elicio’s rights to development of ELI-002.
Elicio is addressing the challenge of direct lymph node engagement
with next-generation immunotherapies based on the AMP platform. This platform allows Elicio to develop numerous differentiated treatment modalities, including therapeutic cancer vaccines, adjuvants, ID vaccines, and immune cell therapy
AMP-lifiers. The AMP platform is intended to deliver conventional immunomodulatory payloads including small molecules, peptides, proteins, and nucleic acids directly and preferentially to the lymph node, which can facilitate interaction with
the various components of the innate and adaptive immune system. In preclinical studies, these interactions result in an enhanced therapeutic immune response. Elicio believes this lymph node-targeting technology has the potential to be broadly
applicable to address significant unmet medical needs.
An amphiphile is a chemical compound with both hydrophilic, or
water soluble, and lipophilic, or lipid soluble, properties. This distinction is central to the development of Elicio’s AMP platform. Of critical importance to the AMP platform is its use of endogenous albumin as the carrier molecule. Albumin
is a large 66.5 kD protein with multiple roles important to maintaining our health, including stabilizing extracellular fluid volume and functioning as a carrier protein for a variety of compounds including drugs, thyroid hormones and fatty
acids. In addition to being present in the serum in blood plasma, albumin is abundant in the interstitial fluid of the tissues, where it drains through the lymphatic capillaries and vessels of the body, passing through numerous lymph nodes
prior to exiting through the subclavian vein and returning to the blood system. As such, Elicio believes endogenous albumin and its ubiquitous presence in the tissues make it an ideal carrier to transport immune therapies and vaccines to the
lymph nodes.
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Elicio’s AMP platform capitalizes on the differences between
the migration routes of large and small molecules through the lymphatic system with the intent of enhancing the immunostimulatory capabilities of various agents by increasing their exposure in the lymph nodes. In addition, the AMP platform
embraces modular conjugation, potentially allowing for application to multiple therapeutic modalities, including peptides, proteins, nucleic acids, and small molecules. Constructed from an albumin-binding lipid tail, a therapeutic payload, and
an optional linker, AMP configurations are designed to emulate the efficient lymphatic navigation of large macromolecules to preferentially accumulate in the lymph nodes, where they can more potently activate immune cells to orchestrate key
features of protective immune responses, including response magnitude and functional quality. When applied to immunostimulatory agents with poor inherent access to the lymph nodes, the AMP strategy can promote their lymph node uptake and, thus,
enhance action on key immune cells. While current AMP candidates are administered subcutaneously, Elicio is also exploring the possibility of intranasal administration. Delivering an antigen intranasally to mucosal tissue holds the potential to
stimulate robust mucosal and systemic immunity, potentially providing more effective protection at the site of infection for mucosally-transmitted infectious diseases, such as HIV, SARS-CoV-2,
influenza, rotavirus, and cholera.
By applying this fundamental mechanistic distinction throughout a
portfolio of product candidates, Elicio believes it can develop immunotherapies that optimally engage the lymph nodes and other immune orchestrating sites to overcome certain therapeutic limitations of currently approved immunotherapies and
enable certain immunotherapy programs in research and development. Therapeutics developed using Elicio’s AMP platform are made up of three core components as shown in the figure below:
AMP construction: A molecular conjugation approach for
delivery of immune therapeutics to lymph nodes
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Albumin-targeting binding vehicle: Binding to endogenous albumin at the injection
site is enabled through the incorporation of a fatty acid chain. This vehicle, which mimics endogenous fatty acids binding naturally to albumin, is designed to provide for optimal binding characteristics which allow for efficient
association with albumin and delivery of the desired payload to the lymph node. Through experimental refinement of this component’s structure, Elicio has selected a two-chain, or diacyl, molecular configuration, with a specific chain
length and saturation of the carbon-backbone, designed to enhance lymph node biodistribution.
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Linker molecule: The second optional component of Elicio’s AMP platform is a linker
molecule made from polyethylene glycol (PEG), which connects the lipophilic-binding functional domain with the therapeutic payload. Elicio believes integration of the PEG-based linker into its AMP construct offers multiple benefits.
Specifically, Elicio believes this enhances the AMP’s hydrophilic properties, in turn enhancing enhances pharmaceutical properties such as solubility. The linker molecule is also intended to protect the therapeutic payload from
enzymatic degradation as it travels through the lymphatic system and to permit Elicio to control payload delivery characteristics.
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Therapeutic payload: Elicio has designed its AMPs for potential use with a broad
array of therapeutic modalities, including small molecules, nucleic acids, peptides, and proteins. Elicio believes this range of available payloads, specifically designed for use with the AMP platform, which enables their direct lymph
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node engagement, provides significant flexibility related to modality selection for
immune system activation and stimulation. Moreover, Elicio believes its use of well-characterized payloads with proven immunological activity will enable it to more rapidly and reliably generate product candidates capable of eliciting a
therapeutic response of clinical benefit.
AMP Platform Mechanism of Action
The feasibility of using albumin to facilitate the delivery of
molecules specifically to the sentinel lymph nodes is well established. Surgeons routinely administer albumin-binding dyes to melanoma and breast cancer patients to visualize the drainage of lymphatic vessels into sentinel lymph nodes to guide
the surgical procedures and increase the accuracy of assessments for potential metastases. These dyes are too small to efficiently accumulate in lymphatics independently, but bind tightly with endogenous albumin in the interstitial fluid at the
injection site, which then chaperones the dyes through the lymphatics into the lymph node. Elicio utilizes similar mechanistic principles to facilitate transport and delivery of the therapeutic AMP constructs to the lymph nodes. Once delivered
to the lymph nodes, the immunomodulatory payload is transferred to APCs to initiate the immune response.
Delivery directly to the lymph nodes
In order to facilitate the generation of antigen-specific T cells,
APCs must deliver three critical signals to the T cell. The first signal involves antigenic peptides, derived from APC protein-processing pathways, presented in the context of the appropriate major histocompatibility complex (MHC) molecules.
Upon encountering an AMP-peptide in the lymph node, APCs engulf and process the AMP construct into antigenic fragments, with APC activity facilitated by activation of certain pathways of the innate immune system, such as Toll-like receptors
(TLRs). These fragments then associate with major histocompatibility complex (MHC) class I or class II structures, which in turn activate the adaptive immune system’s response cascade. The MHC class I peptide antigen complex engages with the T
cell receptor, facilitated by the CD8 co-receptor and co-stimulatory ligands, which increase APC interaction with the T cell.
The second signal involves the APC expressing positive
costimulatory molecules, principally, CD40, CD80, and CD86. Conformational changes related to the CD80 receptor of the APC binding with the CD28 co-receptor on the T cell trigger the activity of CD8+ T cells. At the same time, the MHC class II
antigen complex, along with the coordination of CD4+ T cells, stimulates B cells to produce antibodies directed towards specific epitopes. APCs typically present peptides derived from exogenous protein through the MHC class II pathway, but can
also, when appropriately activated, efficiently cross present exogenous antigen through the MHC class I pathway, resulting in enhanced CD8+ T cell activation. Cross presentation is critical for generating a CD8+ T cell mediated immune response
to viruses and tumors. In the presence of sufficient negative co-stimulatory signals, or the lack of sufficient positive co-stimulation, the interaction between APCs and T cells can lead to tolerization, dysfunction, or death of the T cells
rather than activation and expansion. Elicio’s AMP therapeutics are designed to avoid this occurrence, through the inclusion of an adjuvant intended to enhance the co-stimulatory function of the APCs.
The third signal collectively refers to the cytokine
microenvironment of the immune synapse where the priming interaction between APCs and T cells is occurring. This cytokine combination determines the differentiation and
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fitness of the downstream T cell response. Elicio believes its AMP platform is
able to leverage the concentration of critical immune cells present in the lymph nodes to efficiently activate DCs, which in turn drive and sustain these critical three critical signals to orchestrate the adaptive immune response.
In studies evaluating tumor-specific immune responses targeting E7
protein antigen from Human Papilloma Virus (HPV) therapeutic vaccination of mice resulted in expansion of tumor-specific T cells as shown in the figure below. While vaccination with soluble unmodified CpG induced approximately 20% of
circulating CD8 T cells to be tumor specific, AMP-CpG adjuvanted vaccination generated enhanced responses where as many as 80% of circulating CD8 T cells were tumor specific. These improved responses resulted in tumor regression and durable
responses in 80% of AMP-CpG vaccinated animals, while the soluble comparator achieved similar responses in only 20% of treated animals.
AMP Therapy Generates Improved Responses in HPV-Driven Tumors
ELI-004: Elicio’s Universal Adjuvant
Elicio is developing ELI-004 as a universal AMP-modified CpG
adjuvant for applications in a variety of indications and therapies, including its use as a component of ELI-002 and all of Elicio’s pipeline programs. The AMP-modification is designed to concentrate and retain the smaller molecular size CpG in
the lymphatic system. Elicio is evaluating its use in combination with a variety of disease-specific antigens of smaller molecular size, each AMP-modified to stimulate a powerful and sustained immune response as well as in combination with
unmodified (native) antigens. Elicio believes the preclinical results demonstrate ELI-004’s inherent capabilities and distinguish its immune-boosting strength.
In previous clinical studies conducted by third parties,
CpG-containing oligonucleotides have been shown to be both well tolerated and to exert immune-stimulatory effects through activation of the endosomal toll-like receptor 9 (TLR-9) pathway present in human antigen-presenting DCs and B cells.
Mechanistic studies have demonstrated the ability of CpG-containing oligonucleotides to induce TLR-9 dependent innate immune activation and, subsequently, elicit adaptive immunity in humans. The specific CpG, 7909, which Elicio incorporates
into its vaccine configurations, has been shown to induce both B cell proliferation and DC maturation in clinical trials. Further, CpG-7909 elicited target-specific adaptive immunity when given in combination with an antigen.
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Safety assessments in these and other trials have defined the
absorption, distribution, metabolism, and elimination profiles of oligonucleotides including those containing phosphorothioate linkages, such as CpG-7909. Adverse events were consistent with TLR-9 activation and included local injection site
reactions and flu-like symptoms. Elicio believes its thoughtfully-designed AMP modified CpG adjuvant has the potential to induce an enhanced immune response due to its specific engagement with the lymph nodes.
Preclinical studies evidenced the immune activity generated by
AMP-modified CpG
Elicio evaluated the activity of innate cells in the lymph nodes
of mice 24 hours after administration of soluble and AMP-modified CpG and found that compared to soluble CpG, AMP-CpG induced frequencies of CD11c DCs which were higher for numerous activation markers including CD80, CD86, and CD40. These data
are shown in the figure below. Prior preclinical studies have shown that while soluble CpG induced increased levels of serum cytokines following dosing, AMP-CpG dosing resulted in levels similar to the control group. These data are consistent
with the evidence AMP-CpG exclusively targets the lymph nodes rather than being distributed systemically, which may allow for enhanced immune-activating effects while avoiding some toxicity associated with systemic cytokine release.
AMP-modified CpG showed increased immune activation compared to
soluble CpG in Mice
Persistence of the elevated immune activity was also observed in
long term follow up of animals after completion of a vaccination regimen as reflected in increased T cell activity and cytokine levels illustrated in the figure below.
AMP-modified CpG induced T cell responses which persisted for
months after administration
Beyond ELI-004, Elicio is evaluating an expanded portfolio of
next-generation adjuvants, including various AMP-modified TLRs and danger-associated molecular pattern (DAMP) candidates, and has generated initial proof of concept data in mouse and non-human primate models.
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ELI-007: Elicio’s Product Candidate for Mutant
BRAF-driven Cancers
ELI-007 is a lymph node targeted AMP-peptide vaccine directed at
BRAF V600E mutations also incorporating ELI-004 as an adjuvant. BRAF V600E mutations are present in 45% of melanoma, 10% of colon cancer, and 2% of lung cancer cases. While available small molecule inhibitors targeting BRAF generate initial
responses in BRAF V600E-mutated melanoma, these responses are not sustained because of resistance due to alternative growth signaling pathways and few initial responses occur in BRAF-mutated colon cancer. Previous research has shown T cells can
respond to the driver mutation V600E in BRAF and transfer of tumor-infiltrating lymphocytes recognizing mutated BRAF resulted in durable complete response in a case study. The protein expression of BRAF V600E is maintained at high levels in
these tumors suggesting they would be susceptible to T cells specific for the mutated BRAF. This could mean targeting mutated BRAF may be efficacious even after the tumor has developed resistance to BRAF inhibition.
Funding for the initial development of ELI-007 is provided by a
grant from The Gastro-Intestinal Research Foundation (GIRF). Elicio retains full worldwide rights to both programs and GIRF has no rights to either program, including no restrictions on Elicio’s right to develop the program on a global basis.
ELI-008: Elicio’s Product Candidate for Mutant
TP53-expressing Cancers
ELI-008 is a multivalent lymph node targeted AMP-peptide vaccine
directed at p53 hotspot mutations also incorporating ELI-004 as an adjuvant. Like KRAS, mutations in p53 are found in a large number and wide variety of cancers, accounting for approximately 60% of patients with solid tumors. ELI-008 is being
developed to target hotspot mutations in p53 in solid tumors including CRC, melanoma, and NSCLC. An AMP-peptide vaccine targeting p53 hotspot mutations may be able to potently expand and mature tumor-specific T cells through enhanced delivery
and immune stimulation in draining lymph nodes to generate tumor-specific immunity capable of eliminating tumor tissue.
Funding for the initial development of ELI-008 is provided by a
grant from the Gastro-Intestinal Research Foundation (GIRF). Elicio retains full worldwide rights to both programs and GIRF has no rights to either program, including no restrictions on Elicio’s right to develop the program on a global basis.
Elicio has developed pipeline programs through preclinical proof
of concept in other applications of the AMP platform, prophylactic infectious disease vaccines, and immune cell therapy AMP-lifiers. Elicio is actively exploring partnership opportunities to advance these additional applications of the AMP
platform.
ELI-005: Elicio’s Product Candidate for
Prevention of COVID-19
We have conducted assessments of the AMP platform for inducing
immune responses targeting SARS-CoV-2 for the prevention of COVID-19. Elicio completed non-human primate (NHP) dosing of SARS-CoV-2 Spike Receptor-binding Domain (RBD) protein antigen together with AMP-CpG as the adjuvant component of its
SARS-CoV-2 vaccine candidate, ELI-005. Groups of Rhesus macaques received priming immunization followed four weeks later by booster immunization including two dose levels of AMP-CpG. As indicated in the figure below, Elicio found no clinically
significant site reactogenicities such as redness, swelling or itching, no increases in daily temperature, and no safety signals from blood chemistry or hematology after either the first or second immunizations.
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ELI-005 Induces Cross-reactive SARS-CoV-2 Spike-RBD-specific T
cell Responses in NHPs
ELI-005 immunization was observed to generate ~500-1000-fold
increases in the level of IFN-γ secreting RBD-specific T cells in peripheral blood samples at week six, two weeks following booster immunization. These T cells were found to show cross-reactive specificity against several viral variants of
interest (beta, delta).
Serum antibody responses were also induced with seroconversion
observed for all immunized animals within 2 weeks after prime vaccination, followed by significant further increase in the level of antigen-specific IgG (Binding Antibody Units – BAU/mL) following boost. Serum IgG responses exhibited robust
cross-recognition of RBD antigen for several viral variants of concern (beta, delta, omicron) as well as the ancestral RBD (WH-01) used as the vaccine antigen. Finally, all immunized NHPs generated potent neutralizing serum antibody levels at
week 6, exceeding those observed in convalescent human plasma (CHP) by ~10-fold. As observed for T cell and IgG responses, neutralizing antibody responses induced by ELI-005 exhibited significant activity against several viral variants of
concern (delta and omicron) indicating the potential for inducing broad anti-viral immunity. These data are summarized in the figure below.
ELI-005 Induces Cross-reactive Neutralizing SARS-CoV-2
Spike-RBD-specific Antibody Responses in NHPs
AMP Immune Cell Therapy AMP-lifiers
Elicio's AMP platform has the potential to improve the efficacy of
adoptive cell therapies. TCR T and CAR T cell therapy have shown benefits for some patients, but there remains a need to improve cell expansion, functional persistence, and resistance to tumor-mediated mechanisms of immune escape. Elicio
believes an important reason for these limitations is that TCR T cells and CAR T cells, as currently used, don't effectively engage the lymph nodes, and are not sufficiently activated at these crucial immune sites to support their durable
anti-tumor function. The use of the AMP platform with both TCR T and CAR T cells has the potential to improve T cell expansion, anti-tumor functionality, persistence, and resistance to tumor immune evasion without altering the T cell
manufacturing process. This may provide the potential to improve response rates and enhance response duration.
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In preclinical studies evaluating immune cell therapy against
solid tumors, combination of CAR T or TCR T cells with supportive AMP vaccination regimens boosted the cell therapy benefits in mice relative to comparator treatments which administered cell therapy alone. These improvements in cell therapy
benefits in mice were correlated to efficient lymph node AMP-vaccine delivery enabling significant enhancement in the expansion of adoptively administered T cells coupled with increased T cell infiltration into solid tumors, and increased
anti-tumor effector function.
As shown below, application of this approach to TCR T cell therapy
targeting the tumor-associated antigen gp100 in established B16F10 melanoma in mice resulted tumor eradication and durable prevention of relapse in 30-75% of animals treated with TCR T + AMP-vaccination, while TCR T cell therapy given alone or
in combination with conventional (soluble) vaccination resulted in progressive tumor growth requiring euthanasia in 100% of treated animals. Similar improvements in the frequency and depth of anti-tumor responses have been observed for
AMP-vaccine combinations with CAR T cell therapy.
ELI-011: Elicio’s CD19 CAR T Cell AMP-lifier
Program
Based on the additive effects observed in mouse models combining
AMP-lifiers and CAR T cell therapies, Elicio believes an AMP-based immunotherapy administered in conjunction with a CAR T therapy may generate efficacy improvements. Elicio has entered into a collaboration with the Moffitt Cancer Center to
evaluate the combination of Elicio’s CD19 CAR T cell AMP-lifier, referred to as ELI-011, together with CD19-targeted CAR T cell therapy, in mouse models of B cell lymphoma.
ELI-012: Elicio’s mutant KRAS TCR T Cell
AMP-lifier Program
ELI-012 is Elicio’s mKRAS TCR T cell AMP-lifier, designed for use
in combination with mKRAS-targeted TCR T cell therapy against mKRAS-driven cancers. ELI-012 is ELI-002 administered in combination with TCR-T cells, which creates a new product called ELI-012. ELI-012 is designed to promote the invigoration of
mKRAS-specific TCR T cells in vivo through exposure to activating signals delivered by APCs in the lymph nodes. Following activation in lymph nodes, mKRAS-specific TCR T cells can exhibit improved functional quality, persistence, tumor
infiltration, and anti-tumor activity, resulting in improved disease outcome.
MIT License Agreement
On January 27, 2016, Elicio entered into an Exclusive Patent
License Agreement with MIT, which has been amended from time to time, which it refers to as the MIT License Agreement. Pursuant to the MIT License Agreement, Elicio was granted an exclusive, worldwide license, with the right to sublicense, to
certain patents and
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patent applications owned by MIT related to the AMP technology for the diagnosis,
treatment or prevention of diseases. The licensed patent claims cover vaccine products in development by Elicio for its current lead programs in tumor indications where mutant KRAS, rearranged Anaplastic lymphoma kinase (ALK), or certain other
proteins are a driver of disease, as well as programs using CpG as an adjuvant for immune activation in conjunction with an immunostimulatory agent. The MIT License Agreement established annual license payment obligations and intellectual
property cost reimbursement obligations for which Elicio is responsible, specific product categories (including immunotherapeutic products and adjuvant products) for which Elicio is required to invest specified minimum amounts of research
funding and the timing of such investment, specified development and commercialization milestone obligations, and payments due with respect to the achievement of these milestones.
On January 31, 2019, the MIT License Agreement was amended to add
patent applications owned by MIT describing the use of the Amphiphile technology licensed in the 2016 license to boost the performance of CAR T and other cell therapies. Subsequently, on January 7, 2021, the MIT License Agreement was further
amended to add exclusive rights to patent applications covering binding ligands for CD19 CAR T receptors and methods of screening for ligands to bind with specific CAR T receptors.
Under the terms of the MIT License Agreement, Elicio is obligated
to use commercially reasonable diligent efforts to develop and commercialize licensed products, and to use such efforts to accomplish specified development and commercial launch objectives in accordance with a specified timeline as well as to
expend specified resources in the development and commercialization of immunotherapeutic products and adjuvant products. Elicio is obligated to pay an annual license maintenance fee, which can be credited against royalties paid to MIT during
the same calendar year. Elicio is also obligated to make milestone payments upon the occurrence of specific development and commercialization achievements on a product-by-product basis during the term of the MIT License Agreement, including
those relating to the making of certain regulatory filings, the initiation of certain clinical trials and the achievement of certain sales thresholds. The achievement of each milestone triggers the payment of a set dollar amount to MIT by
Elicio. These milestone payments could, in the aggregate, reach a maximum of $27.5 million. Elicio is obligated to make royalty payments based on net sales by it and its sublicensees equal to (i) a fractional to low single digit percentage of
net sales of products that would infringe the MIT patent rights and (ii) a fractional percentage of net sales of products that could not have been identified, selected, or determined to have biological activity but for the use or modification
of products that would infringe the MIT patent rights. These royalty rates are subject to an upward adjustment if Elicio or a sublicensee commence an action against MIT to declare or render invalid or unenforceable any of the licensed patent
rights; and the amount of royalties payable to MIT are subject to a downward adjustment if Elicio is required to secure certain patent licenses from third parties to avoid infringement by the practice of the licensed patent rights. These
royalties are payable (1) until the expiration of the last to expire of the MIT patent rights with respect to products that would infringe the MIT patent rights and (2) for12 years following the first commercial sale of products that could not
have been identified, selected, or determined to have biological activity but for the use or modification of products that would infringe the MIT patent rights.
Elicio is also obligated to pay a percentage of any revenue that
it or its sublicensees earn from the provision of services using licensed products or that utilizes a process that would infringe the MIT patent rights. Elicio is also obligated to pay a percentage of any payments it receives from its
sublicenses, with certain exceptions. Elicio is also required to share a portion of any funds it or a sublicensee receives in respect of the sale of a regulatory voucher that is granted by any regulatory authority based upon the regulatory
approval of a product subject to the MIT License Agreement for the treatment of a neglected disease. MIT controls the prosecution and maintenance of the licensed patent rights, and Elicio is required to pay all costs and fees associated with
patent prosecution and maintenance of the licensed patents. Patent protection for the MIT licensed patents is being sought in the United States and elsewhere, including Australia, Canada, Europe, Hong Kong and Japan.
The term of the MIT License Agreement will continue in effect
until the expiration or abandonment of all issued patents and filed patent applications within the licensed patent rights, unless earlier terminated. MIT may terminate the MIT License Agreement upon Elicio’s uncured material breach of the MIT
License Agreement or upon the occurrence of certain events, including if Elicio or a sublicensee commence an action against MIT to declare or render invalid or unenforceable any of the licensed patent rights, or upon specified insolvency or
bankruptcy events concerning Elicio. Elicio may terminate the MIT License Agreement without cause upon six months advance written notice to MIT and upon payment of all amounts due MIT through the date such termination takes effect.
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Regeneron Clinical Supply Agreement
On May 16, 2022, Elicio entered into a clinical supply agreement,
or the Clinical Supply Agreement, with Regeneron to evaluate the safety and efficacy of ELI-002 in combination with Regeneron’s LIBTAYO® (cemiplimab), a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells,
in patients with mKRAS-driven tumors. The combination therapy will be studied in mutant KRAS-driven tumors including Stage III and IV NSCLC, Stage IV CRC and unresectable, locally advanced or oligometastatic PDAC. The AMPLIFY-202 study, which
will be conducted by Elicio, is expected to begin after the Phase 1a safety evaluation of ELI-002 in the AMPLIFY-7P study is completed. A Study Coordination Committee (SCC) compromised of equal membership from each of Elicio and Regeneron will
meet quarterly to oversee and coordinate the study.
Each party will provide their respective therapeutic agent for the
trial. Elicio is responsible for covering the cost of the supply of LIBTAYO if Elicio terminates the Clinical Supply Agreement for business reasons, and for covering the cost of any LIBTAYO product damaged or destroyed in Elicio’s possession.
Under the terms of the Clinical Supply Agreement Elicio retains
all rights to any other combinations of ELI-002 with another anti-PD-1 or PD-L1 checkpoint inhibitor outside of the study indications defined under the terms of the collaboration. Elicio additionally retains all rights to the study indications
once the combination study with Regeneron ends. Regeneron has exclusivity in the study indications from the time the agreement was executed until database lock. Elicio retains full worldwide rights to ELI-002, REGN has no rights, and the
agreement does not restrict Elicio’s rights to development of ELI-002.
Intellectual property is of vital importance in Elicio’s field and
in biotechnology generally. Elicio seeks to protect and enhance proprietary technology, inventions, and improvements that are commercially important to the development of its business by seeking, maintaining, and defending patent rights,
whether developed internally or licensed from third parties. Elicio will also seek to rely on regulatory protection afforded through inclusion in expedited development and review, data exclusivity, market exclusivity and patent term extensions
where available.
Elicio has sought patent protection in the United States and
internationally related to the AMP platform technology as well as the mKRAS and universal adjuvant programs. However, Elicio does not own any issued patents covering clinical product candidates and the patent portfolio owned by Elicio currently
comprises only applications. Such applications may not result in issued patents and, even if patents do issue, such patents may not be in a form or scope that will provide Elicio with meaningful protection for its product candidates. Elicio
also relies on trade secrets that may be important to the development of its business. Trade secrets are difficult to protect and provide Elicio with only limited protection, as trade secrets do not protect against independent development of a
technology by third parties.
Elicio expects to file additional patent applications in support
of current and new clinical candidates as well as new platform and core technologies. Elicio’s commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of current and future product
candidates and the methods used to develop and manufacture them, as well as successfully defending any such patents against third- party challenges and operating without infringing on the proprietary rights of others. Elicio’s ability to stop
third parties from making, using, selling, offering to sell or importing its product candidates will depend on the extent to which Elicio has rights under valid and enforceable patents or trade secrets that cover these activities. Elicio cannot
be sure that patents will be granted with respect to any of its pending patent applications or with respect to any patent applications filed by Elicio in the future, nor can Elicio be sure that any patents that may be granted in the future will
be commercially useful in protecting its product candidates, discovery programs and processes.
The terms of individual patents depend upon the legal term of the
patents in the countries in which they are obtained. In most countries in which Elicio files, including the United States, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United States,
a patent term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the U.S. Patent and Trademark Office (USPTO) in examining and granting a patent or may be shortened if a patent is terminally
disclaimed over an earlier filed patent. In the United States, the term of a patent that covers an FDA-approved drug may also be eligible for extension, which permits patent term restoration to account for the patent term lost during the FDA
regulatory review process. The Hatch-Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the subject drug candidate is
under regulatory review. Patent term extension cannot extend the remaining term of a patent beyond a total of
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14 years from the date of product approval, only one patent applicable to an
approved drug may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar provisions to extend the term of a patent that covers an approved drug are
available in Europe and other foreign jurisdictions. In the future, if and when Elicio products receive FDA approval, Elicio expects to apply for patent term extensions on patents covering those products. Elicio plans to seek patent term
extensions to any issued patents it may obtain in any jurisdiction where such patent term extensions are available, however there is no guarantee that the applicable authorities, including the FDA in the United States, will agree with Elicio’s
assessment that such extensions should be granted, and if granted, the length of such extensions.
In some instances, Elicio has submitted and expects to submit
patent applications directly to the USPTO as provisional patent applications. Corresponding non-provisional patent applications must be filed not later than 12 months after the provisional application filing date. While Elicio intends to timely
file non-provisional patent applications relating to its provisional patent applications, Elicio cannot predict whether any such patent applications will result in the issuance of patents that provide it with any competitive advantage.
Elicio files U.S. non-provisional applications and Patent
Cooperation Treaty (PCT) applications that claim the benefit of the priority date of earlier filed provisional applications, when applicable. The PCT system allows a single application to be filed within 12 months of the original priority date
of the patent application, and to designate all of the PCT member states in which national patent applications can later be pursued based on the international patent application filed under the PCT. The PCT searching authority performs a
patentability search and issues a non-binding patentability opinion which can be used to evaluate the chances of success for the national applications in foreign countries prior to having to incur the filing fees. Although a PCT application
does not issue as a patent, it allows the applicant to seek protection in any of the member states through national-phase applications. At the end of the period of two and a half years from the first priority date of the patent application,
separate patent applications can be pursued in any of the PCT member states either by direct national filing or, in some cases by filing through a regional patent organization, such as the European Patent Office. The PCT system delays expenses,
allows a limited evaluation of the chances of success for national/regional patent applications and enables substantial savings where applications are abandoned within the first two and a half years of filing.
For all patent applications, Elicio determines claiming strategy
on a case-by-case basis. Advice of counsel and Elicio business model and needs are always considered. Elicio seeks to file patents containing claims for protection of all useful applications of its proprietary technologies and any products, as
well as all new applications and/or uses that Elicio discovers for existing technologies and products, assuming these are strategically valuable. Elicio continuously reassesses the number and type of patent applications, as well as the pending
and issued patent claims to pursue maximum coverage and value for its processes, and compositions, given existing patent office rules and regulations. Further, claims may be modified during patent prosecution to meet Elicio’s intellectual
property and business needs.
Elicio recognizes that the ability to obtain patent protection and
the degree of such protection depends on a number of factors, including the extent of the prior art, the novelty and non-obviousness of the invention, and the ability to satisfy the enablement requirement of the patent laws. In addition, the
coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted or further altered even after patent issuance. Consequently, Elicio may not obtain or maintain adequate patent
protection for any of its future product candidates or for its technology platform. Elicio cannot predict whether the patent applications it is currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any
issued patents will provide sufficient proprietary protection from competitors. Any patents that Elicio holds may be challenged, circumvented or invalidated by third parties.
In addition to patent protection, Elicio also relies on trade
secrets, know how, other proprietary information and continuing technological innovation to develop and maintain its competitive position. Elicio seeks to protect and maintain the confidentiality of proprietary information to protect aspects of
its business that are not amenable to, or that it does not consider appropriate for, patent protection. Although Elicio takes steps to protect its proprietary information and trade secrets, including through contractual means with its employees
and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to its trade secrets or disclose its technology. Thus, Elicio may not be able to meaningfully
protect its trade secrets. It is Elicio’s policy to require its employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute confidentiality agreements upon the commencement of employment or
consulting relationships with Elicio. These agreements provide that all confidential information concerning Elicio’s business or
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financial affairs developed or made known to the individual during the course of
the individual’s relationship with Elicio is to be kept confidential and not disclosed to third parties except in specific circumstances. Elicio’s agreements with employees also provide that all inventions conceived by the employee in the
course of employment with Elicio or from the employee’s use of its confidential information are Elicio’s exclusive property. However, such confidentiality agreements and invention assignment agreements can be breached and Elicio may not have
adequate remedies for any such breach. In addition, Elicio’s trade secrets may otherwise become known or be independently discovered by competitors. To the extent that Elicio’s consultants, contractors or collaborators use intellectual property
owned by others in their work for Elicio, disputes may arise as to the rights in related or resulting trade secrets, know-how and inventions.
The patent positions of biotechnology companies are generally
uncertain and involve complex legal, scientific and factual questions. Elicio’s commercial success will also depend in part on not infringing upon the proprietary rights of third parties. Third-party patents could require Elicio to alter its
development or commercial strategies, or its products or processes, obtain licenses or cease certain activities. Elicio’s breach of any license agreements or its failure to obtain a license to proprietary rights required to develop or
commercialize its future products may have a material adverse impact on it. If third parties prepare and file patent applications in the United States that also claim technology to which Elicio has rights, Elicio may have to participate in
interference or derivation proceedings in the USPTO to determine priority of invention. For more information, see “Risk Factors—Risks Related to Intellectual Property.”
When available to expand market exclusivity, Elicio’s strategy is
to obtain, or license additional intellectual property related to current or contemplated development platforms, core elements of technology and/or clinical candidates.
Company-owned Intellectual Property
Elicio owns the following patent families and applications:
Elicio has pending U.S. and Canadian patent applications titled
“ALK polypeptides and methods of use thereof”, which are related to its products in development for tumor indications where rearranged ALK is a driver of disease.
Elicio also has a patent family titled “Compounds including a
mutant KRAS sequence and a lipid and uses thereof” with pending applications in the United States, the United Arab Emirates, Australia, Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, South Korea, Mexico, Malaysia, Nigeria, New
Zealand, Russia, Saudi Arabia, Singapore, Thailand, Ukraine, and South Africa. This patent family relates to Elicio’s products in development for tumor indications where mutant KRAS is a driver of disease.
Elicio also has a patent family titled “CpG amphiphiles and uses
thereof” with pending applications in the United States, the United Arab Emirates, Australia, Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, South Korea, Mexico, Malaysia, Nigeria, New Zealand, Russia, Saudi Arabia, Singapore,
Thailand, Ukraine, and South Africa. This patent family relates to Elicio’s products in development for tumor indications where expression of human papillomavirus protein(s) is a driver of disease.
Elicio also has a patent family titled “Compositions and methods
for inducing an immune response against coronavirus” with pending applications in the United States, Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, and Mexico. This patent family relates to the use of Elicio’s AMP
technology, including products in development, in methods of inducing an immune response against coronavirus.
Elicio also has a pending PCT international application titled
“Uses of amphiphiles in immune cell therapy and compositions therefor.” This application relates to the use of Elicio’s AMP technology, including products in development, in immune cell therapy.
Elicio also has a pending PCT international application titled
“Compositions containing polynucleotide amphiphiles and methods of use thereof.” This application relates to aspects of Elicio’s AMP technology platform.
Elicio has sole ownership of these patent applications. If Elicio
is granted patents on these pending applications, it is anticipated that patent expiration would occur between 2037 and 2042 without taking into consideration patent term adjustments or extensions.
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Licensed Intellectual Property
Elicio has an exclusive license from MIT for six patent families
related to aspects of its AMP technology platform:
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“Immunostimulatory compositions and methods of use thereof”, which contains three patents granted in the United States,
patents granted in Europe, Hong Kong, and Japan, as well as pending applications in the United States, Europe, Hong Kong, and Japan, which relates to aspects of Elicio’s AMP platform technology;
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“Albumin binding peptide conjugates and methods thereof,” which contains a patent granted in the United States, as well as
pending applications in the United States, China, Hong Kong, Japan, and Europe, which relates to certain additional aspects of Elicio’s AMP platform technology;
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“Chimeric antigen receptor-targeting ligands and uses thereof” with a pending application in the United States, which relates
to further aspects of Elicio’s AMP platform technology;
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“Compositions for chimeric antigen receptor T cell therapy and uses thereof” with pending applications in the United States,
Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico, New Zealand, and Russia, which relates to the use of Elicio’s AMP platform technology in connection with CAR T therapy;
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“Uses of amphiphiles in immune cell therapy and compositions therefor” with pending application in the United States, Europe,
Hong Kong, and Japan, which relates to use of Elicio’s AMP platform technology in connection with immune cell therapy; and
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“Methods for identifying chimeric antigen receptor-targeting ligands and uses thereof” with a pending application in the
United States, which relates to methods of identifying further ligands for use in Elicio’s AMP platform technology.
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For these patents and for any patents granted on the pending
applications, Elicio anticipates patent expiration to occur between 2033 and 2041, without taking into consideration patent term adjustments or extensions.
Elicio also has an exclusive license from Dr. Roberto Chiarle for
a patent family titled Anaplastic lymphoma kinase (ALK) as oncoantigen for lymphoma vaccination,” which contains two granted U.S. patents. This patent family relates to ALK antigen sequences that may be used in connection with Elicio’s AMP
platform technology. Elicio anticipates patent expiration to occur in 2028 and 2031 without taking into consideration patent term extension.
Elicio faces substantial competition from multiple sources,
including large and specialty pharmaceutical, biopharmaceutical, and biotechnology companies, academic research institutions and governmental agencies, and public and private research institutions. Elicio’s competitors compete with it on the
level of the technologies employed, or on the level of development of product candidates. In addition, many small biotechnology companies have formed collaborations with large, established companies to (i) obtain support for their research,
development and commercialization of products or (ii) combine several treatment approaches to develop longer lasting or more efficacious treatments that may potentially directly compete with Elicio’s current or future product candidates. Elicio
anticipates it will continue to face increasing competition as new therapies and combinations thereof, technologies, and data emerge within the field of immunotherapy and, furthermore, within the treatment of infectious diseases and cancers.
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In addition to the current SOC treatments for patients with
infectious diseases or cancers, numerous commercial and academic preclinical studies and clinical trials are being undertaken by many parties to assess novel technologies and product candidates in the field of immunotherapy. Results from these
studies and trials have fueled increasing levels of interest in the field of immunotherapy specifically in the KRAS field. There are four main segments comprising the competitive landscape targeting mKRAS including small molecules directly
inhibiting mKRAS, small molecules indirectly inhibiting mKRAS, vaccines targeting mKRAS, and lymph node targeted vaccines to mKRAS (ELI-002).
There are four main segments comprising the competitive landscape
targeting mKRAS
In May of 2021, Amgen’s LUMAKRAS® was the first KRAS G12C
inhibitor to receive regulatory approval anywhere with its approval in the United States, under accelerated approval for patients with locally advanced or metastatic NSCLC harboring the KRAS G12C mutation. A second small molecule inhibitor,
KRAZATI®, targeting the KRAS G12C mutation from Mirati Therapeutics received FDA approval on December 12, 2022. In addition to the first two approved molecules targeting a specific KRAS mutation, there are a number of competitors working in the
KRAS development space including several publicly traded and private companies with different modalities at varying stages of development.
There are several other companies developing vaccines targeting
mutant KRAS, which may represent the most direct competition to ELI-002
Gritstone bio, Inc., is developing two viral vectored vaccines
(adenovirus-based) using a heterologous prime/boost therapeutic vaccine approach (GRT-C903 first followed by GRT-R904) currently in Phase 2. Gritstone has established a clinical collaboration with Bristol-Myers Squibb Company (July 2018) to
explore combination therapies with approved checkpoint inhibitors (Opdivo® (nivolumab), and Opdivo® plus Yervoy® (ipilimumab), in patients with advanced solid tumors. Gritstone has presented data on their Phase 1/2 study evaluating the safety,
immunogenicity, and early clinical activity of both SLATE v1 and SLATE-KRAS in combination with PD-1 checkpoint inhibitor Opdivo® (nivolumab) and subcutaneous anti-CTLA-4 antibody Yervoy® (ipilimumab) in patients with metastatic solid tumors
harboring select KRAS mutations (September 2022).
Moderna Inc., is developing an mRNA vaccine, mRNA-5671, currently
in Phase 1. mRNA-5671 is a lipid nanoparticle (LNP)-formulated mRNA-based cancer vaccine that targets four of the most commonly occurring KRAS mutations (G12D, G12V, G13D, and G12C), with potential immunostimulatory and antineoplastic
activities. This asset was previously partnered with Merck & Co., Inc. (Merck ended the collaboration in February 2022).
Hookipa Pharma is developing a viral vectored vaccine
(arenavirus-based), HB-700, in preclinical development for the treatment of KRAS-mutated cancers. Hookipa has entered into a strategic collaboration and license agreement with Roche to develop HB-700 for KRAS-mutated cancers and a second
undisclosed novel arenaviral immunotherapy (October 2022).
Other companies developing clinical stage mKRAS-targeted therapies
include BridgeBio Pharma Inc., Novartis AG, Boehringer Ingelheim, Roche Holding Ltd./Genentech, Inc., Revolution Medicines, Eli Lilly & Co., Inc., Merck & Co.,
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Inc., Relay Therapeutics, InventisBio Co., Moderna Inc., and Janssen
Pharmaceuticals. Additional companies developing preclinical stage mKRAS-targeted therapies include Affini-T Therapeutics Inc., Arvinas, Athenex Inc., Codiak BioSciences Inc., Cue Biopharma, Erasca Inc., and T-Knife GmbH. Pending successful
achievement of clinical and regulatory milestones, these companies all pose potential competition to ELI-002 in mKRAS associated cancers.
Many of Elicio’s competitors, either alone or in combination with
their respective strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, the regulatory approval process, and marketing than Elicio does. Mergers and acquisition activity in
the pharmaceutical, biopharmaceutical and biotechnology sector is likely to result in greater resource concentration among a smaller number of Elicio’s competitors. Smaller or early-stage companies may also prove to be significant competitors,
particularly through sizeable collaborative arrangements with established companies. These competitors also compete with Elicio in recruiting and retain qualified scientific and management personnel and establishing clinical trial sites and
patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, Elicio’s programs.
Elicio’s commercial opportunity could be reduced or eliminated if
one or more of its competitors develop and commercialize products that are safer, more effective, better tolerated, or of greater convenience or economic benefit than Elicio’s proposed product offering. Elicio’s competitors also may be in a
position to obtain FDA or other regulatory approval for their products more rapidly, resulting in a stronger or dominant market position before Elicio is able to enter the market. The key competitive factors affecting the success of all of
Elicio’s programs are likely to be product safety, efficacy, convenience and treatment cost.
Government authorities in the United States, at the federal,
state, and local level, and in other countries, extensively regulate, among other things, the research, development, testing, approval, manufacturing, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing,
import, and export of biopharmaceutical products. In addition, sponsors of biopharmaceutical products participating in Medicaid, Medicare, and other government health care programs are required to comply with mandatory price reporting,
discount, and rebate requirements. Elicio, along with its third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in
which Elicio wishes to conduct studies or seek approval or licensure of its product candidates. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with compliance with applicable statutes and
regulations, requires the expenditure of substantial time and financial resources.
FDA Regulation
In the United States, the FDA regulates biologics under the
Federal Food, Drug, and Cosmetic Act, or FDCA, the Public Health Services Act, or PHSA, and their implementing regulations. The FDA further has issued a growing body of guidance documents, which, while not binding, provide the agency’s current
interpretation of its statutes and regulations. Failure to comply with the applicable U.S. requirements may subject an applicant to administrative or judicial sanctions, such as FDA refusal to approve pending biologics license applications, or
BLAs, or the agency's issuance of warning letters, or the imposition of fines, civil penalties, product recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution brought by the
FDA and the U.S. Department of Justice or other governmental entities.
The process required by the FDA before product candidates may be
marketed in the United States generally involves the following:
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completion of preclinical (or nonclinical) laboratory tests and formulation studies in compliance with the FDA’s good
laboratory practice, or GLP, regulations;
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submission to the FDA of an IND, which must become effective before human clinical trials may begin at United States clinical
trial sites;
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approval by an institutional review board, or IRB, for each clinical site, or centrally, before each trial may be initiated;
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performance of adequate and well-controlled human clinical trials to establish the product candidate’s safety, purity,
potency, and efficacy for its intended use, performed in accordance with good clinical practice, or GCP, as well as IND regulations and other clinical-trial related regulations;
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development of manufacturing processes to ensure the product candidate’s identity, strength, quality, purity, and potency in
compliance with current good manufacturing practice, cGMP, regulations;
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submission to the FDA of a BLA;
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satisfactory completion of an FDA advisory committee review, if applicable;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product candidate is
produced to assess compliance with cGMPs, and to assure that the facilities, methods, and controls are adequate to preserve the therapeutics’ identity, strength, quality, purity, and potency, as well as satisfactory completion of
potential FDA inspection of selected clinical sites and selected clinical investigators to determine GCP compliance; and
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FDA review and approval of the BLA to permit commercial marketing for particular indications for use.
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Preclinical Studies and IND Submission
The testing and approval process of product candidates requires
substantial time, effort, and financial resources. Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product
or disease. Preclinical studies include laboratory evaluation of chemistry, pharmacology, toxicity, and product formulation, and may involve in vitro testing or in
vivo animal studies to assess the potential for toxicity, adverse events, and other safety characteristics of the product candidate, and in some cases to establish a rationale for therapeutic use. Such studies must generally be
conducted in accordance with FDA GLP regulations. The Consolidated Appropriations Act for 2023, signed into law on December 29, 2022, (P.L. 117-328) amended the FDCA and the Public Health Service Act to specify that nonclinical testing for
drugs and biologics may, but is not required to, include in vivo animal studies. According to the amended language, a sponsor may fulfill nonclinical testing requirements by completing various in vitro assays (e.g., cell-based assays, organ chips, or microphysiological systems), in silico studies (i.e., computer modeling), other human or nonhuman
biology-based tests (e.g., bioprinting), or in vivo animal studies.
Prior to commencing the first clinical trial at a U.S.
investigational site with a product candidate, an IND sponsor must submit the results of the nonclinical tests and literature, together with manufacturing information, analytical data, any available clinical data or literature (including data
from clinical trials conducted outside of the United States), and proposed clinical study protocols among other things, to the FDA as part of an IND. An IND is a request from a clinical study sponsor to obtain authorization from the FDA to
administer an investigational drug or biologic product to humans, as well as authorization to administer the product candidate to humans in accordance with a specific clinical trial protocol. Some long-term nonclinical testing to further
establish the safety profile of the product candidate, as well as manufacturing process development and product quality evaluation, continues after the IND is submitted.
An IND goes into effect upon notification by FDA or automatically
30 days after receipt by the FDA, unless the FDA, within the 30–day-time period, notifies the applicant of safety concerns or questions related to one or more proposed clinical trials and places the trial on a clinical hold. In such a case, the
IND sponsor and the FDA must resolve all outstanding concerns or questions posed by the FDA before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during clinical trials due to safety concerns
or non-compliance with applicable regulations. As a result, submission of an IND may not result in FDA authorization to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial
conducted during product development.
Clinical Trials
Clinical trials involve the administration of the investigational
product to human subjects under the supervision of qualified investigators in accordance with federal regulations and GCP requirements, which include the requirements that all research subjects provide their informed consent in writing for
their participation in any clinical trial, as well as review and approval of the trial by an IRB. Investigators must also provide certain information to the clinical trial sponsors to allow the sponsors to make certain financial disclosures to
the FDA. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the trial procedures, the parameters to be used in monitoring safety, the effectiveness criteria to be evaluated, and a
statistical analysis plan. A protocol for each clinical trial, and any subsequent protocol amendments, must be submitted to the FDA as part of the IND. In addition, an IRB at each site participating in the clinical trial, or a central IRB, must
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approve the plan for any clinical trial, informed consent forms, and
communications to trial subjects before a trial commences at that site. An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits, and
whether the planned human subject protections are adequate. The IRB must continue to oversee the clinical trial while it is being conducted. If a product candidate is being investigated for multiple intended indications, separate INDs may also
be required. Status reports summarizing the progress of the clinical trials must be submitted at least annually to the FDA and the IRB and more frequently if suspected unexpected serious adverse reactions occur, findings from other studies
suggest a significant risk to humans exposed to the biologic, findings from animal or in vitro testing suggest a significant risk for human subjects, or other significant safety information is found.
The FDA may order the temporary, or permanent, discontinuation of
a clinical trial at any time, or impose other sanctions on various grounds, including if the agency believes that the clinical trial either is not being conducted in accordance with regulatory requirements or presents an unacceptable risk to
the clinical trial patients. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements or if the trial poses an unexpected serious harm to subjects.
The FDA or an IRB may also impose conditions on the conduct of a clinical trial. Clinical trial sponsors may also choose to discontinue clinical trials as a result of risks to subjects, a lack of favorable results, or changing business
priorities. Some clinical trials also include oversight by an independent group of qualified experts organized by the trial sponsor, known as an independent data monitoring committee, or IDMC, which provides authorization for whether a trial
may move forward at designated check points based on review of certain data from the trial, to which only the IDMC has access, and may recommend halting the trial if it determines that there is an unacceptable safety risk for subjects or other
grounds, such as no demonstration of efficacy.
Sponsors of clinical trials of certain FDA-regulated products
generally must register and disclose certain clinical trial information to a public registry maintained by the National Institutes of Health, or NIH. In particular, information related to the investigational product, patient population, phase
of investigation, trial sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial. Competitors may use this publicly available information to gain knowledge regarding the
progress of development programs. Although sponsors are also obligated to disclose the results of their clinical trials after completion, disclosure of the results may be delayed in some cases for up to two years after the date of completion of
the trial. Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the
federal government. The NIH’s Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and the government has brought enforcement actions against non-compliant clinical trial sponsors. Sponsors or
distributors of investigational products for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions must also have a publicly available policy on evaluating and responding to requests for expanded access requests.
The manufacture of investigational biologics for the conduct of
human clinical trials is subject to cGMP requirements. Investigational biologics and their therapeutic substances that are imported into the United States are also subject to regulation by the FDA. Further, the export of investigational
products outside of the United States is subject to regulatory requirements of the receiving country as well as U.S. export requirements under the FDCA.
In general, for purposes of BLA approval, human clinical trials
are typically conducted in three sequential phases, which may overlap or be combined.
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Phase 1—The product candidate is initially administered to healthy human volunteers
and tested for safety, dosage tolerance, structure-activity relationships, mechanism of action, absorption, metabolism, distribution, and excretion. In the case of some products for severe or life-threatening diseases, such as cancer,
especially when the product may be too inherently toxic to administer ethically to healthy volunteers, the initial human testing is often conducted in patients with the target disease or condition. If possible, Phase 1 trials may also
be used to gain an initial indication of product effectiveness.
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Phase 2—Studies are conducted in limited subject populations with a specified
disease or condition to evaluate preliminary efficacy, identify optimal dosages, dosage tolerance and schedule, possible adverse effects and safety risks, and expanded evidence of safety. Multiple Phase 2 clinical trials may be
conducted by the sponsor to obtain information prior to beginning larger and more extensive clinical trials.
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Phase 3—Clinical trials are undertaken with expanded subject populations, generally
at geographically dispersed clinical trial sites, to generate sufficient data to provide statistically significant evidence of clinical efficacy and safety of the product candidate, to establish the overall risk-benefit profile of the
product candidate, and to provide adequate information for the labeling of the product candidate. Typically, two adequate, well-controlled trials are required by the FDA for biological product approval. Under some limited circumstances,
however, the FDA may approve a BLA based upon a single clinical trial plus confirmatory evidence from a post-market trial or, alternatively, a single large, robust, well-controlled multicenter trial without confirmatory evidence.
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Additional kinds of data may also help to support a BLA, such as
patient experience and real-world data. For appropriate indications sought through supplemental BLAs, data summaries may provide marketing application support. For genetically targeted products and variant protein targeted products intended to
address an unmet medical need in one or more patient subgroups with a serious or life threatening rare disease or condition, the FDA may allow a sponsor to rely upon data and information previously developed by the sponsor or for which the
sponsor has a right of reference, that was submitted previously to support an approved application for a product that incorporates or utilizes the same or similar genetically targeted technology or a product that is the same or utilizes the
same variant protein targeted drug as the product that is the subject of the application.
The FDA may also require, or companies may voluntarily conduct,
additional clinical trials for the same indication after a product is approved. These post-approval trials, referred to as Phase 4 clinical trials, are used to gain additional experience from the treatment of patients in the intended
therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 trials as a condition of approval of a BLA. The results of Phase 4 studies can confirm or refute the effectiveness of a product candidate and can
provide important safety information.
Concurrent with clinical trials, companies usually complete
additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate as well as finalize a process for manufacturing the product in commercial quantities in accordance
with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, manufacturers must develop methods for testing the identity, strength, quality,
potency, and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its
shelf life.
In the Consolidated Appropriations Act for 2023, Congress amended
the FDCA to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug to support marketing authorization, to submit a diversity action plan for such clinical trial. The action plan must include the sponsor’s diversity
goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them. A sponsor must submit a diversity action plan to FDA by the time the sponsor submits the trial protocol to the agency for review.
The FDA may grant a waiver for some or all of the requirements for a diversity action plan. It is unknown at this time how the diversity action plan may affect Phase 3 trial planning and timing or what specific information FDA will expect in
such plans, but if FDA objects to a sponsor’s diversity action plan and requires the sponsor to amend the plan or take other actions, it may delay trial initiation.
Marketing Application Submission, Review by the
FDA, and Marketing Approval
Assuming successful completion of the required clinical and
preclinical testing in accordance with all applicable regulatory requirements, the results of product development, including chemistry, manufacture, and controls information, nonclinical studies, and clinical trial results, including negative
or ambiguous results as well as positive findings, are all submitted to the FDA, along with the proposed labeling, as part of a BLA requesting approval to market the product for one or more indications. A BLA must contain sufficient evidence of
the biological product candidate’s safety, purity, potency and efficacy for its proposed indication or indications. Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a
number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational product to the
satisfaction of the FDA. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis,
if at all.
Under the Prescription Drug User Fee Act, as amended, or PDUFA,
each BLA submission is subject to a substantial application user fee, and the sponsor of an approved BLA is also subject to an annual program fee. The
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FDA adjusts the PDUFA user fees on an annual basis. The application user fee must
be paid at the time of the first submission of the application, even if the application is being submitted on a rolling basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the
first application filed by a small business. Product candidates that are designated as orphan products are also not subject to application user fees, unless the application also includes a non-orphan indication.
In addition, under the Pediatric Research Equity Act, or PREA, a
BLA or supplement to a BLA for a new active ingredient, indication, dosage form, dosage regimen, or route of administration, must contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications
in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant
deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. A sponsor who is planning to submit a marketing application for a
product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration must submit an initial Pediatric Study Plan, or PSP, within sixty days of an end-of-Phase 2 meeting or, if there
is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 clinical trial. The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including trial
objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the
requirement to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed upon initial PSP at any time if changes to the
pediatric plan need to be considered based on data collected from pre-clinical studies, early phase clinical trials or other clinical development programs. Orphan products are exempt from the PREA requirements.
The FDA Reauthorization Act of 2017 introduced a provision
regarding required pediatric studies. Under this statute, for product candidates intended for the treatment of adult cancer which are directed at molecular targets that the FDA determines to be substantially relevant to the growth or
progression of pediatric cancer, original application sponsors must submit, with the marketing application, reports from molecularly targeted pediatric cancer investigations designed to yield clinically meaningful pediatric study data, gathered
using appropriate formulations for each applicable age group, to inform potential pediatric labeling. The FDA may, on its own initiative or at the request of the applicant, grant deferrals or waivers of some or all of this data, as above.
Unlike PREA, orphan products are not exempt from this requirement.
The FDA also may require submission of a risk evaluation and
mitigation strategy, or REMS, if it determines that a REMS is necessary to ensure that the benefits of the product candidate outweigh the risks and to assure safe use of the biological product. The REMS plan could include medication guides,
physician communication plans, assessment plans and/or elements to assure safe use, such as restricted distribution methods, patient registries, or other risk minimization tools. The FDA determines the requirement for a REMS, as well as the
specific REMS provisions, on a case-by-case basis. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS. The FDA will not approve a BLA without a REMS, if required. An assessment of the REMS must also be
conducted at set intervals. Following product approval, a REMS may also be required by the FDA if new safety information is discovered and the FDA determines that a REMS is necessary to ensure that the benefits of the product outweigh the
risks.
Once the FDA receives an application, it has 60 days to review the
BLA to determine if it is substantially complete to permit a substantive review, before it accepts the application for filing. The FDA may request additional information rather than accept an application for filing. In this event, the
application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive
review.
Under the goals and policies agreed to by the FDA under PDUFA, the
FDA has set the review goal of completing its review of 90% of BLAs within ten months of the filing date for a standard application and within six months of the filing date for an application with priority review. For all original BLAs, the ten
and six-month time periods run from the filing date; for all other submissions, including resubmissions, efficacy supplements and other supplements, the FDA’s stated review time periods, ranging from two to ten months, run from the submission
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goal is referred to as the PDUFA date. The PDUFA date is only a goal, and it is
not uncommon for FDA review of a BLA to extend beyond the PDUFA date. The review process and the PDUFA date may also be extended if the FDA requests, or the sponsor otherwise provides, substantial additional information or clarification
regarding the submission.
The FDA may also refer certain applications to an advisory
committee. Before approving a product candidate for which no active ingredient has previously been approved by the FDA, the FDA must either refer that product candidate to an external advisory committee or provide in an action letter a summary
of the reasons why the FDA did not refer the product candidate to an advisory committee. The FDA may also refer other product candidates to an advisory committee if FDA believes that the advisory committee’s expertise would be beneficial. An
advisory committee is typically a panel that includes clinicians and other experts, which review, evaluate, and make a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the
recommendations of an advisory committee, but it considers such recommendations carefully when making product approval decisions.
The FDA reviews a BLA to determine, among other things, whether a
product candidate meets the agency’s approval standards, such as whether the application includes sufficient evidence that the product candidate is safe and effective for the proposed indications, and whether the manufacturing methods and
controls are adequate to assure and preserve the product’s identity, strength, quality, potency, and purity. As part of its review, the FDA likely will re-analyze the clinical trial data, which could result in extensive discussions between the
FDA and the applicant during the review process. Before approving a marketing application, the FDA typically will inspect the facility or facilities where the product is manufactured, referred to as a pre-approval inspection. The FDA will not
approve an application unless it determines that the manufacturing processes and facilities, including contract manufacturers and subcontractors, are in compliance with cGMP requirements and adequate to assure consistent production of the
product within required specifications. Additionally, before approving a marketing application the FDA will inspect one or more clinical trial sites to assure compliance with applicable IND trial requirements and GCP. To assure cGMP and GCP
compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.
After evaluating the marketing application and all related
information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a Complete Response Letter,
or CRL. A CRL indicates that the review cycle of the application is complete and the application will not be approved in its present form, and it describes all of the specific deficiencies that the FDA identified. A CRL generally contains a
statement of specific conditions that must be met in order to secure final approval of the marketing application and may require additional clinical or preclinical testing for the FDA to reconsider the application. The deficiencies identified
may be minor, for example, requiring labeling changes; or major, for example, requiring additional Phase 3 clinical trials. If a CRL is issued, the applicant may either: resubmit the marketing application, addressing all of the deficiencies
identified in the letter; withdraw the application; or request an opportunity for a hearing. The FDA has the goal of reviewing 90% of application resubmissions in either two or six months of the resubmission date, depending on the type of
information included. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s
satisfaction, the FDA may issue an approval letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.
Even if the FDA approves a product, it may limit the approved
indications or populations for use of the product, require that contraindications, warnings, or precautions be included in the product labeling, including a boxed warning, require that post-approval studies, including Phase 4 clinical trials,
be conducted to further assess a product’s safety and efficacy after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other
risk management mechanisms under a REMS which can materially affect the potential market and profitability of the product. The FDA also may not approve label statements that are necessary for successful commercialization and marketing or may
prevent or limit further marketing of a product based on the results of post-marketing trials or surveillance programs.
After approval, some types of changes to the approved product,
such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval. The
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FDA may also withdraw the product approval if compliance with regulatory standards
are not maintained or if problems occur after the product reaches the marketplace. Further, should new safety information arise, additional testing, product labeling, or FDA notification may be required.
Patent Term Restoration
Depending upon the timing, duration and specifics of FDA approval
of Elicio’s biological product candidates, some of Elicio’s U.S. patents may be eligible for limited patent term extension. These patent term extensions permit a patent restoration term of up to five years as compensation for any patent term
lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period
is generally one-half the time between the effective date of an IND, and the submission date of a BLA, plus the time between the submission date of a BLA and the approval of that application. Only one patent applicable to an approved biological
product is eligible for the extension, and the extension must be applied for prior to expiration of the patent. The USPTO in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
Biosimilars and Exclusivity
The Biologics Price Competition and Innovation Act of 2009, or
BPCIA, created an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. To date, a number of biosimilars have been licensed under the BPCIA, and
numerous biosimilars have been approved in Europe. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.
Biosimilarity, which requires no clinically meaningful differences
between the biological product and the reference product in terms of safety, purity, and potency, can be demonstrated through analytical studies, animal studies, and a clinical trial or trials. There must be no difference between the reference
product and a biosimilar in mechanism of action, conditions of use, route of administration, dosage form, and strength. A biosimilar product may be deemed interchangeable with the reference product if it meets the higher hurdle of demonstrating
that it can be expected to produce the same clinical results as the reference product in any given patient and, for products administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched
after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic without such alternation or switching. Upon licensure by the FDA, an interchangeable
biosimilar may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product, although to date no such products have been approved for marketing in the United States.
Complexities associated with the larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway
that are still being worked out by the FDA. At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.
A reference biologic is granted 12 years of data exclusivity from
the time of first licensure of the product, and the first approved interchangeable biological product will be granted an exclusivity period of up to one year after it is first commercially marketed. However, certain changes and supplements to
an approved BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor in interest, or other related entity do not qualify for the 12-year exclusivity period. As part of the Consolidated Appropriations Act
for 2023, Congress amended the PHSA in order to permit multiple interchangeable products approved on the same day to receive and benefit from this one-year exclusivity period. If pediatric studies are performed and accepted by the FDA as
responsive to a written request, the 12-year exclusivity period will be extended for an additional six months. In addition, the FDA will not accept an application for a biosimilar or interchangeable product based on the reference biological
product until four years after the date of first licensure of the reference product. “First licensure” typically means the initial date the particular product at issue was licensed in the United States. Date of first licensure does not include
the date of licensure of (and a new period of exclusivity is not available for) a supplement for the reference product for a subsequent application filed by the same sponsor or manufacturer of the reference product (or licensor, predecessor in
interest or other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device
or strength or for a modification to the structure of the biological product that does
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not result in a change in safety, purity or potency. Therefore, one must determine
whether a new product includes a modification to the structure of a previously licensed product that results in a change in safety, purity or potency to assess whether the licensure of the new product is a first licensure that triggers its own
period of exclusivity. Whether a subsequent application, if approved, warrants exclusivity as the “first licensure” of a biological product is determined on a case-by-case basis with data submitted by the sponsor.
The BPCIA is complex and continues to be interpreted and
implemented by the FDA. In addition, recent government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the
subject of recent litigation. As a result, the ultimate impact, implementation, and impact of the BPCIA is subject to significant uncertainty.
Pediatric Exclusivity
Pediatric exclusivity is a type of non-patent marketing
exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity or listed patents. This six-month exclusivity may be granted if
a sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to
fairly respond to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of
exclusivity or patent protection cover the product are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application. The issuance of a
written request does not require the sponsor to undertake the described studies.
Orphan Product Designation and Exclusivity
The Orphan Drug Act provides incentives for the development of
products for rare diseases or conditions. Specifically, sponsors may apply for and receive Orphan Drug Designation, or ODD, if a product candidate is intended to treat a rare disease or condition, which is generally a disease or condition
affecting less than 200,000 individuals in the United States, or affecting more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making the product available in the United States
will be recovered from United States sales. Additionally, sponsors must present a plausible hypothesis for clinical superiority to obtain ODD if there is a product already approved by the FDA that that is considered by the FDA to be the same as
the already approved product and is intended for the same indication. This hypothesis for clinical superiority must be demonstrated to obtain orphan exclusivity. Orphan drug designation must be requested before submitting a marketing
application for the product candidate and does not convey any advantage in or shorten the duration of the regulatory review and approval process. If granted, ODD entitles the applicant to financial incentives such as opportunities for grant
funding towards clinical study costs, tax advantages, and certain user-fee waivers. After the FDA grants ODD, the identity of the therapeutic agent and its potential orphan use will be disclosed publicly by the FDA; the posting will also
indicate whether the drug or biologic is no longer designated as an orphan product. More than one product candidate may receive an orphan designation for the same indication.
In addition, if a product candidate receives FDA approval for the
indication for which it has ODD, the product is generally entitled to orphan exclusivity, which means the FDA may not approve any other application to market a product containing the same active moiety for the same indication for a period of
seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity. A product is clinically superior if it is safer, more effective or makes a major contribution to patient care.
Thus, orphan drug exclusivity could block the approval of one of Elicio’s potential products for seven years if a competitor obtains approval of the same product as defined by the FDA and Elicio is not able to show the clinical superiority of
its product candidate or if its product candidate’s indication is determined to be contained within the competitor’s product orphan indication. In addition, the FDA will not recognize orphan drug exclusivity if a sponsor fails to demonstrate
upon approval that the product is clinically superior to a previously approved product containing the same active moiety for the same orphan condition, regardless of whether or not the previously approved product was designated an orphan drug
or had orphan drug exclusivity. A product that has received ODD may not receive orphan exclusivity if it is approved for a use that is broader than the indication for which it received the designation. Orphan exclusivity does not prevent the
FDA from approving a different drug or biological product for the same disease or condition, or the same product for a different disease or condition.
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Recent court cases have challenged FDA’s approach to
determining the scope of orphan drug exclusivity; however, at this time the agency continues to apply its long-standing interpretation of the governing regulations and has stated that it does not plan to change any orphan drug implementing
regulations.
Fast Track, Breakthrough Therapy and Priority
Review Designations
The FDA is authorized to designate certain products for expedited
development or review if they are intended for the treatment of serious or life-threatening diseases or conditions, and demonstrate the potential to address unmet medical needs or present a significant improvement over existing therapy. These
programs include fast track designation, breakthrough therapy designation and priority review designation.
To be eligible for a fast track designation, the FDA must
determine, based on the request of a sponsor, that a product candidate is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need by providing a therapy where none
exists or a therapy that may be potentially superior to existing therapy based on efficacy or safety factors. Fast track designation provides opportunities for more frequent interactions with the FDA review team to expedite development and
review of the product. In addition, the FDA may initiate review of sections of a marketing application before the application is complete. This “rolling review” is available if the applicant provides and the FDA approves a schedule for the
submission of the application sections and the sponsor pays any required user fees upon submission of the first section of the application. In some cases, a product with fast track designation may be eligible for accelerated approval or
priority review if the relevant criteria are met. The FDA may rescind, or the sponsor may forfeit, fast track designation if the designation is no longer supported by data emerging from the clinical trial process.
Under the provisions of the Food and Drug Administration Safety
and Innovation Act, or FDASIA, enacted in 2012, a sponsor may request designation of a product candidate as a “breakthrough therapy.” A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or
more other drug or biologic, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically
significant endpoints, such as substantial treatment effects observed early in clinical development. Products designated as breakthrough therapies are eligible for the same benefits described above for fast track designation, as well as
intensive guidance on an efficient development program beginning as early as Phase 1 trials, and a commitment from the FDA to involve senior managers and experienced review staff in a proactive collaborative and cross-disciplinary review. Drugs
or biologics designated as breakthrough therapies are also eligible for accelerated approval of their respective marketing applications.
Finally, the FDA may grant priority review designation to product
candidates that are intended to treat serious conditions and, if approved, would provide significant improvements in the safety or effectiveness over existing therapies. The FDA determines at the time that the marketing application is
submitted, on a case-by-case basis, whether the proposed drug or biologic represents a significant improvement in treatment, prevention or diagnosis of disease when compared with other available therapies. Significant improvement may be
illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting reaction, documented enhancement of patient compliance that may lead to improvement in serious
outcomes, or evidence of safety and effectiveness in a new subpopulation. A priority review designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking
action on a marketing application from ten months to six months for an original application from the date of filing.
Even if a product qualifies for one or more of these programs, the
FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. Furthermore, fast track designation, breakthrough therapy designation and
priority review do not change the standards for approval and may not ultimately expedite the development or approval process.
Accelerated Approval
In addition, products studied for their safety and effectiveness
in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval from the FDA and may be approved on the basis of adequate and well-controlled clinical
trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA may also grant accelerated approval for such a drug or biologic when the product has an effect on an
intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, or IMM, and that is reasonably
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likely to predict an effect on IMM or other clinical benefit, taking into account
the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA will require that a sponsor of a drug receiving accelerated approval perform post-marketing
clinical trials to verify and describe the predicted effect on IMM or other clinical endpoint, and the product may be subject to expedited withdrawal procedures. Drugs and biologics granted accelerated approval must meet the same statutory
standards for safety and effectiveness as those granted traditional approval.
For the purposes of accelerated approval, a surrogate endpoint is
a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Surrogate endpoints can often be measured more easily
or more rapidly than clinical endpoints. An intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug or biologic, such as an effect on IMM. The FDA
has limited experience with accelerated approvals based on intermediate clinical endpoints, but has indicated that such endpoints generally may support accelerated approval when the therapeutic effect measured by the endpoint is not itself a
clinical benefit and basis for traditional approval, if there is a basis for concluding that the therapeutic effect is reasonably likely to predict the ultimate long-term clinical benefit of a drug or biologic.
The accelerated approval pathway is most often used in settings in
which the course of a disease is long and an extended period of time is required to measure the intended clinical benefit of a drug or biologic, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. For example,
accelerated approval has been used extensively in the development and approval of drugs and biologics for treatment of a variety of cancers in which the goal of therapy is generally to improve survival or decrease morbidity and the duration of
the typical disease course requires lengthy and sometimes large clinical trials to demonstrate a clinical or survival benefit.
The accelerated approval pathway is usually contingent on a
sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. As a result, a product candidate approved on this basis is subject to rigorous
post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to establish the effect on the clinical endpoint. Failure to conduct required post-approval studies, or to confirm the predicted
clinical benefit of the product during post-marketing studies, would allow the FDA to withdraw approval of the drug. As part of the Consolidated Appropriations Act for 2023, Congress provided FDA additional statutory authority to mitigate
potential risks to patients from continued marketing of ineffective drugs previously granted accelerated approval. Under the act’s amendments to the FDCA, FDA may require the sponsor of a product granted accelerated approval to have a
confirmatory trial underway prior to approval. The sponsor must also submit progress reports on a confirmatory trial every six months until the trial is complete, and such reports are published on FDA’s website. The amendments also give FDA the
option of using expedited procedures to withdraw product approval if the sponsor’s confirmatory trial fails to verify the claimed clinical benefits of the product.
All promotional materials for product candidates being considered
and approved under the accelerated approval program are subject to prior review by the FDA.
Post-approval Requirements
Any products manufactured or distributed pursuant to FDA approvals
are subject to pervasive and continuing regulation by the FDA, including, among other things, monitoring and record-keeping requirements, reporting of adverse experiences with the product, periodic reporting requirements, providing the FDA with
updated safety and efficacy information, product sampling and distribution requirements, as well as advertising and promotion requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting
products for uses or in patient populations that are not described in the product’s approved uses (known as off-label use), limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities
involving the Internet.
After approval, most changes to the approved product, such as
adding new indications or other labeling claims are subject to prior FDA review and approval of a new BLA or a supplement, which may require the applicant to develop additional data or conduct additional pre-clinical studies and clinical
trials. The FDA may also place other conditions on approvals, including the requirement for a REMS, to assure the safe use of the product. A REMS could include medication guides, physician communication plans or elements to assure safe use,
such as restricted distribution methods, patient registries and other risk minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products.
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In addition, quality control and manufacturing procedures must
continue to conform to applicable manufacturing requirements after approval to ensure the quality and long-term stability of the product. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities,
equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products.
The manufacturing facilities for Elicio’s product candidates must meet cGMP requirements and satisfy the FDA or comparable foreign regulatory authorities before any product is approved and Elicio’s commercial products can be manufactured.
Elicio relies, and expects to continue to rely, on third parties for the production of clinical and commercial quantities of its products in accordance with cGMP regulations. These third-party manufacturers must comply with cGMP regulations
that require, among other things, quality control and quality assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers, including third-party manufacturers,
and other entities involved in the manufacture and distribution of approved biologics are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and
certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Future inspections by the FDA
and other regulatory agencies may identify compliance issues at the facilities of Elicio’s CMOs that may disrupt production or distribution or require substantial resources to correct. In addition, the discovery of conditions that violate these
rules, including failure to conform to cGMP regulations, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA,
including, among other things, voluntary recall and regulatory sanctions as described below.
The FDA also strictly regulates marketing, labeling, advertising,
and promotion of products that are placed on the market. A company can make only those claims relating to a product that are approved by the FDA. Physicians, in their independent professional medical judgment, may prescribe legally available
products for unapproved indications that are not described in the product’s labeling and that differ from those tested and approved by the FDA. Biopharmaceutical companies, however, are required to promote their products only for the approved
indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted
off-label uses may be subject to significant liability, including, but not limited to, criminal and civil penalties under the FDCA and False Claims Act, exclusion from participation in federal health care programs, mandatory compliance programs
under corporate integrity agreements, suspension and debarment from government contracts, and refusal of orders under existing government contracts.
Moreover, the Drug Supply Chain Security Act, or DSCSA, was
enacted with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the United States, including most biological products. The DSCSA imposes phased-in and resource-intensive obligations on
biopharmaceutical manufacturers, wholesale distributors, and dispensers related to product tracking and tracing over a 10-year period that is expected to culminate in November 2023. Among the requirements of this legislation, manufacturers are
required to provide certain information regarding the products to wholesale distributors and dispensers to which product ownership is transferred, label products with a product identifier, and keep certain records regarding the product. A
manufacturers must also verify that purchasers of the manufacturer’s products are appropriately licensed. Further, under this legislation, manufacturers have product investigation, quarantine, disposition, and notification responsibilities
related to counterfeit, diverted, stolen, and intentionally adulterated products that would result in serious adverse health consequences of death to humans, as well as products that are the subject of fraudulent transactions or which are
otherwise unfit for distribution such that they would be reasonably likely to result in serious health consequences or death.
FDA’s post-market requirements are continuously evolving and
additional requirements may apply. For instance, in March 2020, the U.S. Congress passed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which includes various provisions regarding FDA drug shortage reporting requirements,
as well as provisions regarding supply chain security, such as risk management plan requirements, and the promotion of supply chain redundancy and domestic manufacturing. Any changes of law may require that Elicio modify how it conducts its
business and may require additional expenditure to ensure that Elicio is in compliance.
Later discovery of previously unknown problems with a product,
including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result
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in significant regulatory actions. Such actions may include refusal to approve
pending applications, license or approval suspension or revocation, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, cyber letters, modification of promotional materials or labeling, provision
of corrective information, imposition of post-market requirements including the need for additional testing, imposition of distribution or other restrictions under a REMS, product recalls, product seizures or detentions, refusal to allow
imports or exports, total or partial suspension of production or distribution, FDA debarment, injunctions, fines, consent decrees, corporate integrity agreements, suspension and debarment from government contracts, and refusal of orders under
existing government contracts, exclusion from participation in federal and state health care programs, restitution, disgorgement, or civil or criminal penalties, including fines and imprisonment, and adverse publicity, among other adverse
consequences.
Additional Controls for Biologics
To help reduce the increased risk of the introduction of
adventitious agents, the PHSA emphasizes the importance of manufacturing controls for products whose attributes cannot be precisely defined. The PHSA also provides authority to the FDA to immediately suspend licenses in situations where there
exists a danger to public health, to prepare or procure products in the event of shortages and critical public health needs, and to authorize the creation and enforcement of regulations to prevent the introduction or spread of communicable
diseases in the United States and between states.
After a BLA is approved, the product may also be subject to
official lot release as a condition of approval. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to
official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing the results of all of the manufacturer’s tests performed on the lot. The FDA may also perform certain
confirmatory tests on lots of some products before releasing the lots for distribution by the manufacturer.
In addition, the FDA conducts laboratory research related to the
regulatory standards on the safety, purity, potency, and effectiveness of biological products.
Fraud and Abuse, Data Privacy and Security, and
Transparency Laws and Regulations
Although Elicio currently does not have any products on the
market, its business activities and current and future arrangements with investigators, health care professionals, consultants, third-party payors and customers may be subject to regulation and enforcement by numerous federal and state
regulatory and law enforcement authorities in the United States in addition to the FDA, including potentially the Department of Justice, the Department of Health and Human Services and its various divisions, including the Centers for Medicare
and Medicaid Services, or CMS, and the Health Resources and Services Administration, the Department of Veterans Affairs, the Department of Defense, and state and local governments. Elicio’s business activities must comply with numerous health
care laws, including but not limited to, anti-kickback and false claims laws and regulations as well as data privacy and security laws and regulations, which are described below, as well as state and federal consumer protection and unfair
competition laws.
The federal Anti-Kickback Statute, which regulates, among other
things, marketing practices, educational programs, pricing policies, and relationships with health care providers or other entities, prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting,
or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order, or the referral to another
for the furnishing or arranging for the furnishing of any item or service reimbursable under Medicare, Medicaid, or other federal health care programs, in whole or in part. The term “remuneration” has been interpreted broadly to include
anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between biopharmaceutical industry members on one hand and prescribers, purchasers, formulary managers, and beneficiaries on the other. There are certain
statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors are drawn narrowly, and practices that involve remuneration that may be alleged to be intended to induce
prescribing, purchases, or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does
not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and
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circumstances. Several courts have interpreted the statute’s intent requirement to
mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal health care covered business, including purchases of products paid by federal health care programs, the statute has been violated. The
Patient Protection and Affordable Care Act, or ACA, of 2010, as amended, also modified the intent requirement under the Anti-Kickback Statute to a stricter standard, such that a person or entity no longer needs to have actual knowledge of the
statute or specific intent to violate it in order to have committed a violation. In addition, the ACA also provided that a violation of the federal Anti-Kickback Statute is grounds for the government or a whistleblower to assert that a claim
for payment of items or services resulting from such violation constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
The federal civil False Claims Act, or FCA, prohibits, among other
things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to, or approval by, the federal government, knowingly making, using, or causing to be made or used a false record or
statement material to a false or fraudulent claim to the federal government, or avoiding, decreasing, or concealing an obligation to pay money to the federal government. A claim includes “any request or demand” for money or property presented
to the U.S. government. The civil False Claims Act has been used to assert liability on the basis of kickbacks and other improper referrals, improperly reported government pricing metrics such as Best Price or Average Manufacturer Price,
improper use of Medicare provider or supplier numbers when detailing a provider of services, improper promotion of off-label uses, and allegations as to misrepresentations with respect to products, contract requirements, and services rendered.
Intent to deceive is not required to establish liability under the civil False Claims Act. Civil False Claims Act actions may be brought by the government or may be brought by private individuals on behalf of the government, called “qui tam”
actions. If the government decides to intervene in a qui tam action and prevails in the lawsuit, the individual will share in the proceeds from any fines or settlement funds. If the government declines to intervene, the individual may pursue
the case alone. The civil FCA provides for treble damages and a civil penalty for each false claim, such as an invoice or pharmacy claim for reimbursement, which can aggregate into millions of dollars. For these reasons, since 2004, False
Claims Act lawsuits against biopharmaceutical companies have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements regarding certain sales practices and promoting off label uses. Civil
False Claims act liability may further be imposed for known Medicare or Medicaid overpayments, for example, overpayments caused by understated rebate amounts that are not refunded within 60 days of discovering the overpayment, even if the
overpayment was not caused by a false or fraudulent act. In addition, conviction or civil judgment for violating the FCA may result in exclusion from federal health care programs, and suspension and debarment from government contracts, and
refusal of orders under existing government contracts.
The government may further prosecute conduct constituting a false
claim under the criminal False Claims Act. The criminal False Claims Act prohibits the making or presenting of a claim to the government knowing such claim to be false, fictitious, or fraudulent and, unlike the civil False Claims Act, requires
proof of intent to submit a false claim.
The civil monetary penalties statute is another potential statute
under which biopharmaceutical companies may be subject to enforcement. Among other things, the civil monetary penalties statue imposes fines against any person who is determined to have knowingly presented, or caused to be presented, claims to
a federal health care program that the person knows, or should know, is for an item or service that was not provided as claimed or is false or fraudulent.
The federal Health Insurance Portability and Accountability Act of
1996, or HIPAA, also created federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations
or promises, any of the money or property owned by, or under the custody or control of, a health care benefit program, regardless of whether the payor is public or private, in connection with the delivery or payment for health care benefits,
knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing, or covering up by any trick or device
a material fact or making any materially false statements in connection with the delivery of, or payment for, health care benefits, items, or services relating to health care matters. Additionally, the ACA amended the intent requirement of
certain of these criminal statutes under HIPAA so that a person or entity no longer needs to have actual knowledge of the statute, or the specific intent to violate it, to have committed a violation.
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Under the federal Physician Payments Sunshine Act and its
implementing regulations, manufacturers of biologics for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) must make annual reports to CMS regarding payments and other
transfers of value made to or at the request of covered recipients, such as, but not limited to, physicians, physician assistants, nurse practitioners, clinical nurse specialists, and certified registered nurse anesthetists and teaching
hospitals, as well as ownership and investment interests held by physicians and their immediate family. Certain payments for clinical trials are included within the ambit of this law. CMS makes the reported information publicly available.
Further, Elicio may be subject to data privacy and security
regulation by both the federal government and the states in which it conducts its business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or the HITECH Act, and its respective implementing
regulations impose requirements on covered entities relating to the privacy, security, and transmission of individually identifiable health information, known as protected health information. Among other things, the HITECH Act, through its
implementing regulations, makes HIPAA’s security standards and certain privacy standards directly applicable to business associates, defined as a person or organization, other than a member of a covered entity’s workforce, that creates,
receives, maintains, or transmits protected health information on behalf of a covered entity for a function or activity regulated by HIPAA. The HITECH Act also strengthened the civil and criminal penalties that may be imposed against covered
entities, business associates, and individuals, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated
with pursuing federal civil actions. In addition, other federal and state laws, such as the California Consumer Privacy Act, may govern the privacy and security of health and other information in certain circumstances, many of which differ from
each other in significant ways and may not be preempted by HIPAA, thus complicating compliance efforts.
Many states have also adopted laws similar to each of the above
federal laws, which may be broader in scope and apply to items or services reimbursed by any third-party payor, including commercial insurers. Certain state laws also regulate sponsors’ use of prescriber-identifiable data. Certain states also
require implementation of commercial compliance programs and compliance with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict
payments or the provision of other items of value that may be made to health care providers and other potential referral sources; impose restrictions on marketing practices; or require sponsors to track and report information related to
payments, gifts, and other items of value to physicians and other health care providers. Furthermore, to distribute products commercially, Elicio must comply with state laws requiring the registration of manufacturers and wholesale distributors
of drug and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Recently, states
have enacted or are considering legislation intended to make drug prices more transparent and deter significant price increases, typically as consumer protection laws. These laws may affect Elicio’s future sales, marketing, and other
promotional activities by imposing administrative and compliance burdens.
If Elicio’s operations are found to be in violation of any of the
laws or regulations described above or any other laws that apply to it, Elicio may be subject to penalties or other enforcement actions, including criminal and significant civil monetary penalties, damages, fines, disgorgement, imprisonment,
exclusion from participation in government health care programs, corporate integrity agreements, suspension and debarment from government contracts and non-procurement transactions such as grants, and refusal of orders under existing government
contracts, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of Elicio’s operations, any of which could adversely affect Elicio’s ability to operate its business and its results operations. Any
action against us for violation of these laws, even if Elicio successfully defends against it, could cause Elicio to incur significant legal expenses and divert its management’s attention from the operation of its business.
To the extent that any of Elicio’s products are sold in a foreign
country, Elicio may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate
compliance programs and reporting of payments or transfers of value to health care professionals.
Coverage and Reimbursement Generally
The commercial success of Elicio’s product candidates and its
ability to commercialize any approved product candidates successfully will depend in part on the extent to which governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers, and other
third-party payors provide coverage
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for and establish adequate reimbursement levels for Elicio’s product candidates.
Government authorities, private health insurers, and other organizations generally decide which therapeutics they will pay for and establish reimbursement levels for health care. A growing trend in recent years is the containment of health care
costs. Accordingly, governmental payors are increasingly trying control therapeutic prices through reimbursement restrictions, rebates, mandatory discounts, and formulary restrictions, among other strategies.
Medicare is a federal health care program administered by the
federal government that covers individuals aged 65 and over as well as individuals with certain disabilities. Drugs and biologics may be covered under one or more sections of Medicare depending on the nature of the product and the conditions
associated with and site of administration. For example, under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities which provide coverage for outpatient prescription drugs. Part D plans include both
stand-alone prescription drug benefit plans and prescription drug coverage as a supplement to Medicare Advantage plans. Unlike Medicare Parts A and B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required
to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level.
Medicare Part B covers most injectable drugs and biologics given
in an in-patient setting and some products administered by a licensed medical provider in hospital outpatient departments and doctors’ offices. Medicare Part B is administered by Medicare Administrative Contractors, which generally have the
responsibility of making coverage decisions. Subject to certain payment adjustments and limits, Medicare generally pays for a Part B-covered drug or biologic based on a percentage of manufacturer-reported average sales price, which is regularly
updated. Elicio believes that its product candidates, which are intended to be administered by a health care professional in a clinical environment, will be subject to the Medicare Part B rules.
In the United States, the European Union, and other markets for
Elicio’s product candidates, government authorities and third-party payors are increasingly attempting to limit or regulate the price of medical products and services, particularly for new and innovative products and therapies, which often has
resulted in average selling prices lower than they would otherwise be and sometimes at or below the provider’s acquisition cost. In the United States, it is also common for government and private health plans to use coverage determinations to
leverage rebates from sponsors in order to reduce the plans’ net costs. These restrictions and limitations influence the purchase of health care services and products and lower the realization on sponsors’ sales of prescription therapeutics.
Third-party payors are developing increasingly sophisticated methods of controlling health care costs. Third-party payors may limit coverage to specific therapeutic products on an approved list, or formulary, which might not include all of the
FDA-approved products for a particular indication or might impose high copayment amounts to influence patient choice. Third-party payors also control costs by requiring prior authorization or imposing other dispensing restrictions before
covering certain products and by broadening therapeutic classes to increase competition. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in
addition to their safety and efficacy. Absent clinical differentiators, third-party payors may treat products as therapeutically equivalent and base formulary decisions on net cost. To lower the prescription cost, sponsors frequently rebate a
portion of the prescription price to the third-party payors. Recently, purchasers and third-party payors have begun to focus on value of new therapeutics and have sought agreements in which price is based on achievement of performance metrics.
Federal programs also impose price controls through mandatory
ceiling prices on purchases by federal agencies and federally funded hospitals and clinics and mandatory rebates on retail pharmacy prescriptions paid by Medicaid and Tricare. By example, payment or reimbursement of prescription therapeutics by
Medicaid or Medicare requires sponsors to submit certified pricing information to CMS. The Medicaid Drug Rebate statute and state statutes requires sponsors to calculate and report price points, which are used to determine mandatory rebate
payments or negotiate supplemental rebate payments on both the state and federal level and Medicaid payment rates for certain therapeutics. For therapeutics paid under Medicare Part B, sponsors must also calculate and report their Average Sales
Price, which is used to determine the Medicare Part B payment rate. Furthermore, as a condition of receiving Medicare Part B reimbursement for eligible drugs or biologicals, the manufacturer is required to participate in other government health
care programs, including the Medicaid Drug Rebate Program and the 340B Drug Pricing Program. The Medicaid Drug Rebate Program requires biopharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the
Secretary of HHS as a condition for states to receive federal matching funds for the manufacturer’s outpatient therapeutic products furnished to Medicaid patients. Under the 340B Drug Pricing Program, the manufacturer must extend discounts to
entities that participate in the program. In addition, therapeutics
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covered by certain government payor programs are subject to an additional
inflation penalty which can substantially increase rebate payments. Certain states have also enacted laws that require that manufacturers report certain pricing information, including drug price increases. States laws may also limit the amount
that prices may be increased or require negotiation of supplemental rebates for new drugs entering the market at price points determined to be high. Refusal to negotiate supplemental rebates can negatively affect market access and provider
reimbursement.
Private payors often rely on the lead of the governmental payors
in rendering coverage and reimbursement determinations. Therefore, achieving favorable CMS coverage and reimbursement is usually a significant gating issue for successful introduction of a new product. In addition, government programs as a
condition of participation mandate fixed discounts or rebates from sponsors regardless of formulary position or utilization and may utilize mechanisms such as formulary placement to attain further price reductions, which can greatly reduce
realization on the sale.
Further, the increased emphasis on managed health care in the
United States and on country and regional pricing and reimbursement controls in the European Union will put additional pressure on product pricing, reimbursement, and utilization, which may adversely affect Elicio’s future product sales and
results of operations. These pressures can arise from rules and practices of managed care groups, competition within therapeutic classes, judicial decisions and governmental laws and regulations related to Medicare, Medicaid, and health care
reform, biopharmaceutical coverage and reimbursement policies, and pricing in general. Patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors to
reimburse all or part of the associated health care costs. Sales of Elicio’s product candidates will therefore depend substantially, both domestically and abroad, on the extent to which the costs of Elicio’s products will be paid by health
maintenance, managed care, pharmacy benefit and similar health care management organizations, or reimbursed by government health administration authorities, such as Medicare and Medicaid, private health insurers, and other third-party payors.
In addition, in some foreign countries, the proposed pricing for a
drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price has been agreed.
Some countries may require the completion of additional studies that compare the cost-effectiveness of Elicio’s product candidate to currently available therapies (so called health technology assessment, or HTA) in order to obtain reimbursement
or pricing approval. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of
medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the
market. Other member states allow companies to fix their own prices for drug products but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. There can be no assurance that any country that has
price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Elicio’s products. Historically, products launched in the European Union do not follow price
structures of the United States and generally tend to by significantly lower.
As a result of the above, Elicio may need to conduct expensive
pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of Elicio’s products, in addition to the costs required to obtain marketing approvals in the United States and in other jurisdictions. Elicio’s
product candidates may not be considered medically necessary or cost-effective, or the rebate percentages required to secure coverage may not yield an adequate margin over cost. Additionally, companies are increasingly finding it necessary to
establish bridge programs to assist patients access new therapies during protracted initial coverage determination periods.
Moreover, a payor’s decision to provide coverage for a product
does not imply that an adequate reimbursement rate will be approved or that significant price concessions will not be required to avoid restrictive conditions. High health plan co-payment requirements may result in patients refusing
prescriptions or seeking alternative therapies. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on Elicio’s investment in therapeutic development.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which Elicio receives regulatory approval, less favorable coverage
policies and reimbursement rates may be implemented in the future. Legislative proposals to reform health care or reduce costs under government insurance programs may result in lower reimbursement for Elicio’s products and product candidates or
exclusion of Elicio’s products and product candidates from coverage. The cost containment measures that health care payors and
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providers are instituting and any health care reform could significantly reduce
Elicio’s revenues from the sale of any approved product candidates. Elicio cannot provide any assurances that it will be able to obtain and maintain third-party coverage or adequate reimbursement for Elicio’s product candidates in whole or in
part.
Health Care Reform Measures
In the United States and some foreign jurisdictions, there have
been, and continue to be, several legislative and regulatory changes and proposed changes regarding the health care system that could prevent or delay marketing approval of product and therapeutic candidates, restrict or regulate post-approval
activities, and affect the ability to profitably sell product and therapeutic candidates that obtain marketing approval. The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that
could prevent, limit or delay regulatory approval of Elicio’s product and therapeutic candidates. If Elicio is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Elicio is not able
to maintain regulatory compliance, Elicio may lose any marketing approval that it otherwise may have obtained and it may not achieve or sustain profitability, which would adversely affect Elicio’s business, prospects, financial condition and
results of operations. Moreover, among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in health care systems with the stated goals of containing health care costs, improving
quality and/or expanding access.
For example, the Patient Protection and Affordable Care Act, as
amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”), was enacted in March 2010 and has had a significant impact on the health care industry in the United States. The ACA expanded coverage for the uninsured
while at the same time containing overall health care costs. With regard to biopharmaceutical products, the ACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are
calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in
Medicaid managed care organizations, established annual fees on manufacturers of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount program. Additionally, the CREATES Act, which became law on December
20, 2019, aims to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the existence of a REMS for certain
products, to deny generic product developers access to samples of brand products. Because generic product developers need samples to conduct certain comparative testing required by the FDA, some have attributed the inability to timely obtain
samples as a cause of delay in the entry of generic products. To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish the
necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly
uncertain and its potential effects on any of Elicio’s future commercial products are unknown.
Following several years of litigation in the federal courts, in
June 2021, the U.S. Supreme Court upheld the ACA when it dismissed a legal challenge to the ACA’s constitutionality. Further legislative and regulatory changes under the ACA remain possible, but it is unknown what form any such changes or any
law would take and how or whether it may affect the biopharmaceutical industry as a whole or Elicio’s business in the future. Elicio expects that changes or additions to the ACA, the Medicare and Medicaid programs, and changes stemming from
other health care reform measures, especially with regard to health care access, financing or other legislation in individual states, could have a material adverse effect on the health care industry in the United States.
In addition, other legislative changes have been proposed and
adopted in the United States since the ACA that affect health care expenditures. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in
2013 and was extended by the Consolidated Appropriations Act for 2023, and will remain in effect through 2032 unless additional Congressional action is taken.
Moreover, there has been heightened governmental scrutiny over the
manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to
product pricing, review the
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relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for drug products. In May 2019, DHHS issued a final rule to allow Medicare Advantage plans the option to use step therapy for Part B drugs beginning January 1, 2020. This final rule codified a DHHS
policy change that was effective January 1, 2019.
More recently, in August 2022, President Biden signed into the law
the Inflation Reduction Act of 2022, or the IRA. Among other things, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. Starting in 2023, a
manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the drug product’s price increases faster than the rate of inflation. This calculation is made on a drug product by
drug product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D. Additionally, starting in payment year 2026, CMS will negotiate drug
prices annually for a select number of single-source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected
by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.
Individual states in the United States have also increasingly
passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and
transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In December 2020, the U.S. Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate
pharmaceutical benefit managers (“PBMs”) and other members of the health care and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.
Elicio cannot predict the likelihood, nature or extent of
government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. Elicio expects that additional state and federal health care reform measures will be adopted in the
future, any of which could limit the amounts that federal and state governments will pay for health care products and services, including any future drug products for which Elicio secures marketing approval.
The Foreign Corrupt Practices Act
The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S.
individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party, or candidate for the purpose of influencing any act or decision of the
foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to
maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, and suspension and debarment from government contracts, and refusal of orders
under existing government contracts.
European Union Drug Development
In the European Union, or EU, Elicio’s product candidates and
products, should they receive marketing authorization in the EU, will be subject to extensive regulatory requirements. As in the United States, medicinal products can be marketed only if a marketing authorization from the competent regulatory
agencies has been obtained. Similar to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory controls. Although the EU Clinical Trials Directive 2001/20/EC has
sought to harmonize the EU clinical trials regulatory framework, setting out common rules for the control and authorization of clinical trials in the EU, the EU member states have transposed and applied the provisions of the Directive
differently. This has led to some variations in the member state regimes.
In April 2014, the Clinical Trials Regulation, (EU) No 536/2014,
was adopted and it became effective on January 31, 2022. The Clinical Trials Regulation will be directly applicable in all of the EU Member States, repealing the current Clinical Trials Directive 2001/20/EC. The extent to which ongoing clinical
trials will be governed by the Clinical Trials Regulation will depend on when the clinical trial is initiated or on the duration of an ongoing trial. As of January 2023, all new clinical trials must comply with the Clinical Trials Regulation.
In addition, any clinical trial
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that was already under way as of January 1, 2023 and continues for more than three
years from the day on which the Clinical Trials Regulation becomes applicable (i.e., January 31, 2025), the Clinical Trials Regulation will at that time begin to apply to the clinical trial.
The Clinical Trials Regulation aims to simplify and streamline the
approval of clinical trials in the European Union. The main characteristics of the regulation include: a streamlined application procedure via a single entry point, the “EU portal” or Clinical Trial Information System, or CTIS; a single set of
documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts.
Part I is assessed by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States concerned). Part II is assessed separately by each Member State concerned.
Strict deadlines have been established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the national law of the concerned EU Member State.
European Data Collection
The collection and use of personal health data in the EU is
governed by the General Data Protection Regulation, or GDPR. The GDPR applies to any company established in the European Economic Area, or EEA, (which includes the EU Member States plus Iceland, Liechtenstein, and Norway) and to companies
established outside the EEA that process personal data in connection with the offering of goods or services to data subjects in the EEA or the monitoring of the behavior of data subjects in the EEA. The GDPR establishes stringent requirements
applicable to the processing of personal data, including strict requirements relating to the validity of consent of data subjects, expanded disclosures about how personal data is used, requirements to conduct data protection impact assessments
for “high risk” processing, limitations on retention of personal data, special provisions affording greater protection to and requiring additional compliance measures for “special categories of personal data” including health and genetic
information of data subjects, mandatory data breach notification (in certain circumstances), “privacy by design” requirements, and direct obligations on service providers acting as processors. The GDPR also prohibits the international transfer
of personal data from the EEA to countries outside of the EEA unless made to a country deemed to have adequate data privacy laws by the European Commission or a data transfer mechanism has been put in place. Failure to comply with the GDPR
requirements may subject an entity to litigation, regulatory investigations, enforcement notices and/or fines of up to 20 million Euros or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as
well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill.
The GDPR may also impose additional compliance obligations
relating to the transfer of data between companies and their subsidiaries or other business partners. For example, on July 16, 2020, the Court of Justice of the European Union (CJEU), issued a landmark opinion in the case Maximilian Schrems vs. Facebook (Case C-311/18), called Schrems II. This decision (a) calls into question commonly relied upon data transfer mechanisms as between
the EU Member States and the United States (such as the Standard Contractual Clauses) and (b) invalidates the EU-U.S. Privacy Shield on which many companies had relied as an acceptable mechanism for transferring such data from the EU to the
United States. The CJEU is the highest court in Europe and the Schrems II decision heightens the burden on data importers to assess U.S. national security laws on their business and future actions of EU
data protection authorities are difficult to predict.
United Kingdom Regulation
As of January 1, 2021, EU law no longer directly applies in the
United Kingdom. The United Kingdom has adopted existing EU medicines regulation as standalone UK legislation with some amendments to reflect procedural and other requirements with respect to marketing authorizations and other regulatory
provisions.
In order to market medicines in the United Kingdom, manufacturers
must hold a UK authorization. On January 1, 2021, all EU marketing authorizations were converted to UK marketing authorizations subject to a manufacturer opt-out. UK medicines legislation is subject to future regulatory change under the
Medicines and Medical Devices Act 2021, which sets out a framework for the adoption of medicines regulation. Guidance issued by the Medicines and Healthcare products Regulatory Agency, or MHRA, states that the United Kingdom will have the power
to take into account marketing authorizations made under the EU decentralized and mutual recognition procedures. In addition, the MHRA’s guidance has been updated to refer to new national licensing procedures including new routes of evaluation
for novel and biotechnological products.
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Different rules will apply in Northern Ireland following
implementation of the Northern Ireland Protocol. In Northern Ireland, EU central marketing applications will continue to apply.
The Trade and Cooperation Agreement between the EU and the United
Kingdom contains an Annex in relation to medicinal products with the objective of facilitating availability of medicines, promotion of public health and consumer protection in respect of medicinal products. The Annex provides for mutual
recognition of good manufacturing practice (GMP) inspections and certificates, meaning that manufacturing facilities do not need to undergo duplicate inspections for the two markets. The Annex establishes a Working Group on Medicinal Products
to deal with matters under the Trade and Cooperation Agreement, facilitate co-operation and for the carrying out of technical discussions. It is expected that further bilateral discussions will continue with respect to regulatory areas not the
subject of the Trade and Cooperation Agreement, including pharmacovigilance. The Trade and Cooperation Agreement also does not include reciprocal arrangements for the recognition of batch testing certification. However, the United Kingdom has
listed approved countries, including the EEA which will enable UK importers and wholesales to recognize certain certification and regulatory standards. The European Commission has not adopted such recognition procedures.
Relatedly, following the United Kingdom’s withdrawal from the EU,
the GDPR has been implemented in the United Kingdom (as the UK GDPR). The UK GDPR sits alongside the UK Data Protection Act 2018 which implements certain derogations in the EU GDPR into United Kingdom law. Under the UK GDPR, companies not
established in the United Kingdom but who process personal data in relation to the offering of goods or services to individuals in the United Kingdom, or to monitor their behavior will be subject to the UK GDPR – the requirements of which are
(at this time) largely aligned with those under the EU GDPR and as such, may lead to similar compliance and operational costs with potential fines of up to £17.5 million or 4% of global turnover. In 2022, the UK government proposed and debated
the Data Protection and Digital Information Bill to harmonize the 2018 Data Protection Act, UK GDPR, and the Privacy and Electronic Communications Regulations under one legislative framework. However, progress on the bill stalled as the
government continues to assess the most optimal approach to data protection reform.
Rest of the World Regulation
For other countries outside of the EU and the United States, such
as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. Additionally, clinical trials to support applications
for marketing authorization in such jurisdictions must be conducted in accordance with GCP requirements and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
If Elicio fails to comply with applicable foreign regulatory
requirements, Elicio may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
As of April 13, 2023, Elicio had 24 employees, all of whom were
full-time, and of whom nine have Ph.D. or M.D. degrees, and 20 are engaged in research and development and manufacturing activities. Elicio does not have any employees represented by a labor union or covered under a collective bargaining
agreement.
Talent Acquisition and Retention
Elicio recognizes its employees largely contribute to its success.
To this end, Elicio supports business growth by seeking to attract and retain best-in-class talent. Elicio uses internal and external resources to recruit highly skilled candidates for open positions. Elicio believes it is able to attract and
retain superior talent as measured by its minimal turnover rate and high employee service tenure.
Total Rewards
Elicio’s total rewards philosophy has been to create investment in
its workforce by offering a competitive compensation and benefits package. Elicio provides employees with compensation packages including base salary, annual incentive bonuses, and long-term equity incentive awards. Elicio also offers
comprehensive employee benefits, such as life, disability, and health insurance, health savings and flexible spending accounts, paid time off, and a 401(k) plan. It is Elicio’s express intent to be an employer of choice in its industry by
providing a market-competitive compensation and benefits package.
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Diversity, Equity, and Inclusion
Elicio believes a diverse workforce is critical to its success.
Elicio’s mission is to value differences in races, ethnicities, religions, nationalities, genders, ages, and sexual orientations, as well as education, skill sets, and experience. Elicio is focused on inclusive hiring practices, fair and
equitable treatment, organizational flexibility, and training and resources.
Training and Development
Elicio believes in encouraging employees in becoming lifelong
learners by providing ongoing learning and leadership training opportunities. While Elicio strives to provide real-time recognition of employee performance, it has a formal annual review process not only to determine pay and equity adjustments
tied to individual contributions, but to identify areas where training and development may be needed.
Elicio’s current headquarters is comprised of 13,424 square feet
of office and laboratory space. The lease term is for eight years. The initial annual rent is $1,235,008 with a 3% annual increase. The lease termination date is February 28, 2030. Elicio believes the space is adequate to meet its near-term
needs.
From time to time, Elicio may become involved in litigation or
legal proceedings relating to claims arising from the ordinary course of its business. Elicio is not currently a party to any material legal proceedings.
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FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Investors should read the following discussion
and analysis of Angion’s financial condition and results of operations together with its consolidated financial statements and the related notes appearing elsewhere in this proxy statement/prospectus/information statement. In addition to the
historical financial information, this discussion contains forward-looking statements that involve risk, assumptions and uncertainties, such as statements of Angion’s plans, objectives, expectations, intentions, forecasts and projections.
Angion’s actual results and the timing of selected events could differ materially from those discussed in these forward-looking statements as a result of several factors, including those set forth under the section of this proxy
statement/prospectus/information statement titled “Risk Factors,” which investors should carefully read to gain an understanding of the important factors that could cause actual results to differ materially from Angion’s forward-looking
statements. Please also see the section titled “Cautionary Note Regarding Forward-Looking Statements” in this proxy statement/prospectus/information statement.
Overview
Angion had been a clinical-stage biopharmaceutical company focused
on the discovery, development, and commercialization of novel small molecule therapeutics to address chronic and progressive fibrotic diseases, prior to Angion’s 2022 Strategic Realignment. Angion’s goal was to transform the treatment paradigm
for patients suffering from these potentially life-threatening conditions for which there are no approved medicines or where existing approved medicines have known limitations. Angion’s product candidates and programs included ANG-3070, a TKI
formerly in development as a treatment for fibrotic diseases; a ROCK2 preclinical program targeted towards the treatment of fibrotic diseases; a CYP11B2 preclinical program targeted towards diseases related to aldosterone synthase
dysregulation; and a CYP26 (retinoic acid metabolism) inhibitor program targeted towards a number of indications, including cancer; and ANG-3777, a HGF mimetic. If Angion does not complete the merger transaction with Elicio, Angion could move
forward with developing ANG-3070 and conducting further preclinical studies for its ROCK2 program.
Angion’s 2022 Strategic Realignment was announced following
Angion’s June 2022 termination of Angion’s Phase 2 “JUNIPER” dose-finding trial for ANG-3070 in patients with primary proteinuric kidney diseases, specifically FSGS and IgAN. The JUNIPER trial was terminated in the interests of patient safety
based upon a reassessment of the risk/benefit profile of ANG-3070 in patients with established serious kidney disease. Angion completed the data collection work necessary related to the JUNIPER trial to ascertain whether the drug had any
effect, positive or negative, in patients with fibrotic kidney diseases and determined there was no economically-viable path forward for ANG-3070 in primary proteinuric kidney diseases.
On January 17, 2023, Angion entered into and announced a
definitive merger agreement with Elicio under which Elicio will merge with a wholly-owned subsidiary of Angion in an all-stock transaction. Upon completion of the Merger, the combined company will focus on advancing Elicio’s proprietary lymph
node AMP technology to develop immunotherapies, with a focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors.
Angion has currently suspended clinical development activities in
anticipation of the announced Merger, and does not have any products approved for sale and has not generated any revenue from product sales since Angion’s inception and do not expect to generate revenue from product sales unless Angion
successfully develops, and Angion or Angion’s collaborators commercialize, Angion’s product candidates, which Angion does not expect to occur in the near future, if ever. Angion’s net losses were $38.8 million and $54.6 million for the years
ended December 31, 2022 and 2021, respectively. As of December 31, 2022, Angion had an accumulated deficit of $253.9 million. Angion expects to continue to incur net losses for the foreseeable future.
In addition, if Angion resumes clinical development of Angion’s
product candidates absent the completion of the announced Merger and if Angion seeks regulatory approval for any of Angion’s product candidates or those for which Angion retains the right to commercialize in the future, Angion would need to
incur additional expenses as it develops and expands its clinical, regulatory, quality, manufacturing and commercialization capabilities, and incurs significant commercialization expenses for marketing, sales, manufacturing and distribution if
Angion were to obtain marketing approval for such product candidates.
Angion has relied on third parties in the conduct of its
preclinical studies and clinical trials and for manufacturing and supply of its product candidates. Angion has no internal manufacturing capabilities, and if Angion continues to develop product candidates, Angion expects to continue to rely on
third parties, many of whom are
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single-source suppliers, for Angion’s preclinical study and clinical trial
materials. In addition, Angion does not have a marketing or sales organization or commercial infrastructure. Accordingly, if Angion is able to develop and obtain approval for one or more product candidates, it will incur significant expenses to
develop a marketing and sales organization and commercial infrastructure in advance of generating any product sales of wholly-owned product candidates or those for which Angion retains the right to commercialize.
Furthermore, Angion would need to make continued investment in
development studies, registration activities and the development of commercial support functions including quality assurance and safety pharmacovigilance before Angion would be in a position to sell any of its product candidates, if approved.
The Initial Public Offering and Concurrent Private Placement
The Initial Public Offering (IPO) and Concurrent Private
Placement, which both closed on February 9, 2021, generated aggregate net proceeds of approximately $107.0 million, after deducting the underwriting discounts and commissions, private placement fee and estimated offering expenses payable by
Angion.
Restructuring and Long-Lived Asset impairment
On January 4, 2022, Angion announced a reduction in force
impacting less than half of its employees at that time. Angion’s decision to engage in this reduction resulted from an assessment of Angion’s internal resource needs, given the results of the Phase 3 study of ANG-3777 in patients at risk for
DGF would likely not support a regulatory approval in that population and the Phase 2 study in CSA-AKI would not support a Phase 3 trial in that indication. This reduction was a cost-cutting measure across the organization to support Angion’s
2022 primary focus on the clinical development of its investigational asset ANG-3070, a highly selective, oral tyrosine kinase receptor inhibitor in development as a treatment for fibrotic diseases, as well as advancing preclinical assets to
IND-enabling studies. In connection with the reduction in force, which Angion completed in the first half of 2022, Angion incurred termination costs, which include severance, benefits and related costs, of approximately $3.2 million, of which
$2.4 million were paid during the year ended December 31, 2022 and Angion expects to pay the remaining $0.8 million on or before September 2023.
On July 25, 2022, Angion announced an additional reduction in
force of the majority of its 37 employees. This reduction in force, completed as of December 31, 2022, was a cash preservation measure and impacted employees across the organization. In connection with the reduction in force, Angion recorded a
charge of approximately $3.0 million in the year ended December 31, 2022. Angion paid $2.2 million during the year ended December 31, 2022 and the remaining $0.8 million was paid in in the first quarter of 2023. These charges are primarily
one-time termination benefits payable in cash.
The significant cut in the number of employees from the reduction
in force announced on July 25, 2022 and the suspension of certain of Angion’s operations in deference to its 2022 Strategic Realignment impacted the use of Angion’s leased facilities. As of December 31, 2022, Angion was no longer conducting
operations in Angion’s Newton, Massachusetts facility or its leased facility in Uniondale, New York, other than to store equipment. Angion determined that the right-of-use assets related to each facility were impaired. As a result, Angion
recognized an impairment of $3.0 million related to the leases to write down the right-of-use assets to its fair value based on estimated future cash flows (see Note 10 to the consolidated financial statements included in this proxy
statement/prospectus/information statement).
License, Collaboration and Grant Agreements
License Agreement with Vifor Pharma
In November 2020, Angion granted Vifor Pharma, an exclusive,
global (excluding Greater China), royalty-bearing license, for the commercialization of ANG-3777 in all Renal Indications, beginning with DGF and CSA-AKI. The Vifor License also grants Vifor Pharma exclusive rights, with a right to sublicense
subject to Angion’s consent for certain specified conditions, to develop and manufacture ANG-3777 for commercialization in Renal Indications worldwide (excluding Greater China) in cooperation with Angion or independently. Angion retains the
right to develop and commercialize combination therapy products combining ANG-3777 with its other proprietary molecules, subject to Vifor Pharma's right of first negotiation with respect to global (excluding Greater China) rights to such
combination therapy products in the Renal Indications.
Pursuant to the Vifor License and specifically based upon the
clinical development plan for ANG-3777 set forth in the Vifor License, Angion is entitled to receive $80 million in upfront and near-term clinical milestone payments,
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including $30 million in up-front cash that was received in November 2020, and a
$30 million equity investment, a $5 million convertible note that subsequently converted into common stock with the IPO and $25 million of which was received in the Concurrent Private Placement with Angion’s IPO. Angion is also eligible to
receive post-approval milestones of up to approximately $260.0 million and sales-related milestones of up to $1.585 billion, providing a total potential deal value of up to $1.925 billion (subject to certain specified reductions and offsets),
plus tiered royalties on net sales of ANG-3777 at royalty rates of up to 40%. Under the Vifor License, Angion is responsible for executing a pre-specified clinical development plan designed to obtain regulatory approvals of ANG-3777 for DGF and
CSA-AKI. For the years ended December 31, 2022 and 2021, Angion recognized license revenue related to the Vifor License of $2.3 million and $27.5 million, respectively. As of December 31, 2022, Angion had completed its performance obligations
under the Vifor License agreement and recognized all remaining deferred revenue as of December 31, 2022.
On October 26, 2021, Angion announced that the Phase 3 trial of
ANG-3777 in DGF did not achieve its primary endpoint and the data were not expected to be sufficient evidence to support an indication in the studied DGF population. On December 14, 2021, Angion announced that the Phase 2 trial of ANG-3777 in
CSA-AKI did not achieve its primary endpoint. The Vifor License includes additional milestone and royalty objectives related to the clinical development plan for ANG-3777 which had included a Phase 3 study for CSA-AKI and a Phase 4 confirmatory
study in DGF. Angion does not expect to receive any clinical, post-approval, or sales milestones, or royalties, as Angion does not intend to continue to pursue the current clinical development plan for ANG-3777. In 2022, Angion continued to
discuss with Vifor Pharma the analyses of the results of the clinical trials announced in the fourth quarter of 2021 and the future of the collaboration with Vifor.
Components of Results of Operations
The following discussion summarizes the key factors Angion’s
management believes are necessary for an understanding of its financial statements.
Revenue
Angion does not have any products approved for sale and have not
generated any revenue from product sales. Angion’s revenue to date primarily has been derived from government funding consisting of U.S. government grants and contracts, and revenue under Angion’s license agreements, specifically the Vifor
License.
Grant Revenue
Angion’s grants and contracts reimburse Angion for direct and
indirect costs relating to the grant projects and also provide Angion with a pre-negotiated profit margin on total direct and indirect costs of the grant award, excluding subcontractor costs, after giving effect to directly attributable costs
and allowable overhead costs. Funds received from grants and contracts are generally deemed to be earned and recognized as revenue as allowable costs are incurred during the grant or contract period and the right to payment is realized.
Contract Revenue
Angion’s license agreements comprise elements of upfront license
fees, milestone payments based on development and royalties based on net product sales. The timing of Angion’s operating cash flows may vary significantly from the recognition of the related revenue. Income from upfront payments is recognized
when Angion satisfies the performance obligations in the contract, which can result in recognition at either a point in time or over the period of continued involvement. Other revenue, such as milestone payments, are recognized when achieved.
Angion’s revenue to date has been generated from payments received
pursuant to the Vifor License Agreement. Angion recognizes revenue from upfront payments over the term of Angion’s estimated period of performance using a cost-based input method under Topic 606, Revenue from Contracts with Customers.
In addition to receiving an upfront payment, Angion may also be
entitled to milestones and other contingent payments upon achieving predefined objectives. If a milestone is considered probable of being reached, and if it is probable that a significant revenue reversal would not occur, the associated
milestone amount would also be included in the transaction price.
Angion expects that any license revenue Angion generates from any
future collaboration partners, will fluctuate in the future as a result of the timing and amount of upfront, milestones and other collaboration agreement payments and other factors.
239
Operating Expenses
Cost of Grant Revenue
Angion’s cost of grant revenue primarily relates to personnel-related
costs and expenses for grant projects.
Research and Development Expenses
To date, Angion’s research and development expenses have primarily
related to discovery efforts and preclinical and clinical development of Angion’s product candidates. Angion recognizes research and development expenses as they are incurred and payments made prior to the receipt of goods or services to be
used in research and development are capitalized until the goods or services are received. Angion’s research and development expenses consist primarily of:
|
•
|
personnel costs, including salaries, payroll taxes, employee benefits and stock-based compensation, for personnel in research
and development functions;
|
|
•
|
costs associated with medical affairs activities;
|
|
•
|
fees paid to consultants, clinical testing sites and contract research organizations (CROs), including in connection with
Angion’s preclinical studies and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and
statistical compilation, analysis and reporting;
|
|
•
|
contracted research and license agreement fees with no alternative future use;
|
|
•
|
costs related to acquiring, manufacturing and maintaining clinical trial materials and laboratory supplies;
|
|
•
|
depreciation of equipment and facilities;
|
|
•
|
legal expenses related to clinical trial agreements and material transfer agreements; and
|
|
•
|
costs related to preparation of regulatory submissions and compliance with regulatory requirements.
|
Other than with respect to reimbursable expenses required to be
recorded under Angion’s government grants and contracts, Angion does not allocate Angion’s expenses by product candidates. A significant amount of Angion’s direct research and development expenses included payroll and other personnel expenses
for Angion’s departments that supported multiple product candidate research and development programs and, other than as specified above, Angion does not record research and development expenses by product. However, research and development
expenses were primarily driven by expenses relating to the development of ANG-3777 and ANG-3070 in 2022 and 2021. For the year ended December 31, 2022, Angion’s total research and development expense includes a reduction to stock-based
compensation expense of $1.3 million due to the forfeiture of stock-based awards for employees terminated as a result of the 2022 Strategic Realignment. Of Angion’s total research and development expenses for the years ended December 31, 2022
and 2021, 79% and 62%, respectively, of such expenses were from external third-party sources and the remaining 21% and 38%, respectively, were from internal sources.
General and Administrative Expenses
General and administrative expenses consist primarily of
personnel-related expenses, such as salaries, payroll taxes, employee benefits and stock-based compensation, for personnel in executive, operational, finance and human resources functions. Other significant general and administrative expenses
include allocation of facilities costs, accounting and legal services and expenses associated with obtaining and maintaining patents. A portion of the general and administrative expenses are reimbursed through the overhead rates contained in
Angion’s grants with the U.S. Government.
Restructuring and Impairment Expenses
Restructuring and impairment expenses include costs associated
with the significant cut in the number of employees from the reductions in force announced in January and July 2022 and Angion’s suspension of certain of Angion’s operations in deference to its 2022 Strategic Realignment impacted the use of its
leased facilities. These costs consist of termination benefits to Angion’s former employees and impairment of the right-of-use assets for its leased facilities. See Note 10 in Angion’s consolidated financial statements included in this proxy
statement/prospectus/information statement for more information on the restructuring expenses and long-lived asset impairments.
240
Other Income (Expense)
Convertible Notes Recorded at Fair Value
Angion elected the fair value option for recognition of its
convertible notes. Angion’s convertible notes were subject to re-measurement each reporting period with gains and losses reported through Angion’s consolidated statements of operations. All of Angion’s convertible notes were converted into
shares of Angion’s common stock upon the closing of Angion’s initial public offering.
Liability Classified Series C Convertible Preferred Stock Recorded
at Fair Value
Series C convertible preferred stock includes settlement features
that result in liability classification. The initial carrying value of the Series C convertible preferred stock was accreted to the settlement value, the fair value of the securities to be issued upon the conversion of the Series C Preferred
Stock. The discount to the settlement value was accreted to interest expense using the effective interest method. During 2020, certain of the convertible notes were exchanged for Series C convertible preferred stock. As the exchange was
accounted for as a modification, the Series C convertible preferred stock that was exchanged for the convertible notes (the Exchanged Series C Shares) continued to be recorded at fair value. The Exchanged Series C Shares were subject to
re-measurement each reporting with gains and losses reported through Angion’s consolidated statements of operations. All shares of Angion’s Series C convertible preferred stock converted into common stock in connection with the IPO.
Warrant Liability
Angion has accounted for certain of its freestanding warrants to
purchase shares of Angion’s common stock as liabilities measured at fair value, in accordance with ASC 815, Derivatives and Hedging (ASC 815). The warrants are subject to re-measurement at each reporting period with gains and losses reported
through Angion’s consolidated statements of operations.
Foreign Exchange Transaction Gain
Foreign currency transaction gains, primarily related to
intercompany loans, are recorded as a component of other income (expense) in Angion’s consolidated statements of operations.
Earnings in Equity Method Investment
Earnings in equity method investment represents Angion’s 10%
interest in NovaPark that is accounted for under the equity method.
Interest Income
Interest income consists of interest earned on Angion’s cash and
cash equivalents.
241
Results of Operations
Comparison for the Years Ended December 31, 2022
and 2021
The following table summarizes Angion’s results of operations for the
periods indicated:
|
|
| |
Year Ended December 31,
|
| |
|
| |
|
|||
|
|
| |
2022
|
| |
2021
|
| |
$ Change
|
| |
% Change
|
|
|
| |
(In thousands, except percentages)
|
|||||||||
|
Revenue:
|
| |
|
| |
|
| |
|
| |
|
|
Contract revenue
|
| |
$2,301
|
| |
$27,506
|
| |
$(25,205)
|
| |
(91.6)%
|
|
Grant revenue
|
| |
—
|
| |
806
|
| |
(806)
|
| |
(100.0)%
|
|
Total revenue
|
| |
2,301
|
| |
28,312
|
| |
(26,011)
|
| |
(91.9)%
|
|
Operating expenses:
|
| |
|
| |
|
| |
|
| |
|
|
Cost of grant revenue
|
| |
—
|
| |
433
|
| |
(433)
|
| |
(100.0)%
|
|
Research and development
|
| |
18,100
|
| |
48,698
|
| |
(30,598)
|
| |
(62.8)%
|
|
General and administrative
|
| |
14,637
|
| |
18,488
|
| |
(3,851)
|
| |
(20.8)%
|
|
Restructuring and impairment expenses
|
| |
9,185
|
| |
—
|
| |
9,185
|
| |
100.0%
|
|
Total operating expenses
|
| |
41,922
|
| |
67,619
|
| |
(25,697)
|
| |
(38.0)%
|
|
Loss from operations
|
| |
(39,621)
|
| |
(39,307)
|
| |
(314)
|
| |
0.8%
|
|
Other income (expense), net
|
| |
814
|
| |
(15,266)
|
| |
16,080
|
| |
(105.3)%
|
|
Net loss
|
| |
$(38,807)
|
| |
$(54,573)
|
| |
$15,766
|
| |
(28.9)%
|
Contract Revenue
Contract revenue decreased by $25.2 million, for the year ended
December 31, 2022 compared to the same period in 2021. Since Angion does not intend to continue the clinical development plan for ANG-3777 currently set forth under its Vifor License agreement, which had included a Phase 3 study in cardiac
surgery involving CSA-AKI and a Phase 4 confirmatory study in DGF, Angion performed a reassessment of the performance period and estimated costs for the completion of the performance obligations. This accelerated the revenue recognition, in the
year ended December 31, 2022, related to the upfront payment Angion received from Vifor Pharma when the license agreement with Vifor Pharma was entered into in 2020.
As of December 31, 2022, Angion has completed all of its
performance obligations under the Vifor License and recognized all remaining deferred revenue under the agreement.
Grant Revenue
Grant revenue decreased by $0.8 million, or 100%, for the year
ended December 31, 2022 compared to the same period in 2021. The decrease is attributable to a decrease in reimbursable costs relating to Angion’s grant from the U.S. Department of Defense in the year ended December 31, 2022. Angion does not
expect to receive any grant revenues for the foreseeable future.
Cost of Grant Revenue
Cost of grant revenue decreased by $0.4 million, or 100%, for the
year ended December 31, 2022 compared to the same period in 2021. The decrease is primarily due to a decrease in personnel-related costs and expenses applied as Angion believes the work under U.S. Department of Defense grant had been completed
in the year ended December 31, 2021.
Research and Development Expenses
Research and development expenses decreased by $30.6 million, or
62.8%, from the year ended December 31, 2022 compared to the year ended December 31, 2021. The net decrease in research and development expenses was primarily due to a $16.1 million reduction in clinical trial related expenses and R&D
consulting and subcontractor expenses as a result of the completion of ANG-3777 trials, and a $14.8 million decrease in salary, bonus and stock-based compensation primarily due to lower headcount following the reductions in force announced in
January and July 2022. These decreases were offset in part by a net increase of $0.3 million in other operating expenses.
242
General and Administrative Expenses
General and administrative expenses decreased by $3.9 million, or
20.8%, from the year ended December 31, 2022 compared to the year ended December 31, 2021. The decrease was primarily due to a net decrease of $5.0 million in salary, bonus and stock-based compensation due to the reductions in force announced
in January and July 2022 as well as a decrease of $0.6 million in consultant expenses. These decreases were offset in part by a net increase of $1.7 million in professional services expense, including audit, tax, legal and insurance due to
Angion’s 2022 Strategic Alignment.
Restructuring and Impairment Expenses
During the year ended December 31, 2022, Angion incurred
restructuring and impairment expenses in the amount of $9.2 million. Included in restructuring expenses were $6.2 million one-time termination benefit charges incurred in connection with the reductions in force announced in January and July
2022 and noncash impairment charges of $3.0 million in connection with Angion’s long-lived assets primarily associated with its leased facility in Uniondale, New York (see Note 10 and Note 15 to the consolidated financial statements in this
proxy statement/prospectus/information statement for additional information). There were no restructuring and impairment expenses incurred during the year ended December 31, 2021.
Other Income (Expense), Net
Other income (expense) increased by $16.1 million for the year
ending December 31, 2022 compared to the same period in 2021. The increase is primarily due to an increase in earned interest income of $0.5 million, a decrease of $14.1 million of loss from the first quarter of 2021 as a result of the increase
in fair value related to Angion’s warrant liability, convertible notes, and Series C convertible preferred stock for which Angion elected the fair value option as most of these instruments were no longer outstanding after Angion’s IPO in
February 2021. There was also a reduction of $2.1 million in interest expense, primarily related to interest associated with convertible notes and Series C convertible preferred stock in 2020 that were converted into equity upon Angion’s IPO in
February 2021. The convertible notes and warrants both require re-measurement at each balance sheet date with gains and losses reported through Angion’s consolidated statement of operations. These increases were offset in part by a $0.9 million
gain from the forgiveness of Angion’s PPP loan in the second quarter of 2021.
Liquidity and Capital Resource
Sources and Uses of Liquidity
Angion has incurred losses and negative cash flows from operations
since inception, and Angion anticipates that Angion will incur losses for the foreseeable future. To date, Angion hasnot generated any revenue from product sales. Angion has funded its operations primarily through the receipt of grants, the
sale of debt and equity securities, and proceeds from license agreements. In February 2021, Angion generated aggregate net proceeds of approximately $107.0 million from Angion’s IPO and Concurrent Private Placement, after deducting the
underwriting discounts and commissions. As of December 31, 2022, Angion had $50.5 million of cash and cash equivalents and an accumulated deficit of $253.9 million, compared to $88.8 million of cash and cash equivalents and an accumulated
deficit of $215.1 million as of December 31, 2021.
On March 10, 2023, Silicon Valley Bank (SVB), at which Angion
maintains cash and cash equivalents in multiple accounts, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. The failure of SVB exposed
Angion to liquidity and credit risk prior to the completion of the FDIC resolution of SVB in a manner that fully protects all depositors. At the end of March 2023, Angion transferred substantially all of its cash and cash equivalents from SVB
to an asset manager.
Future Cash Needs and Funding Requirements
Based on Angion’s current operating plan, Angion believes Angion’s
cash and cash equivalents are expected to be sufficient to fund planned operations for at least 12 months, well into 2024, following the issuance date of Angion’s consolidated financial statements. However, Angion has based its projections of
operating capital requirements on assumptions that may prove to be incorrect and Angion may use all its available capital resources sooner than Angion expects. Angion is unable to estimate the exact amount of its operating capital requirements.
The amount and timing of Angion’s future funding requirements will depend on many factors, including, but not limited to:
243
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•
|
Angion’s ability to complete the Merger or, if the Merger is not completed, identify and consummate another strategic
transaction;
|
|
•
|
the scope, progress, results and costs of researching and developing product candidates, and conducting preclinical studies
and clinical trials;
|
|
•
|
the outcome of any future clinical trials, for any existing or future product candidates;
|
|
•
|
whether Angion is able to take advantage of any FDA expedited development and approval programs for any of its product
candidates;
|
|
•
|
the extent to which COVID-19 may impact Angion’s business, and financial condition;
|
|
•
|
the outcome, costs and timing of seeking and obtaining and maintaining FDA and any foreign regulatory approvals;
|
|
•
|
the number and characteristics of product candidates Angion pursues, including product candidates in preclinical development;
|
|
•
|
the ability of Angion’s product candidates to progress through clinical development successfully;
|
|
•
|
Angion’s need to expand its research and development activities, including to conduct additional clinical trials;
|
|
•
|
market acceptance of Angion’s product candidates, including physician adoption, market access, pricing and reimbursement;
|
|
•
|
the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies;
|
|
•
|
Angion’s ability to maintain, expand and defend the scope of Angion’s intellectual property portfolio, including the amount
and timing of any payments potentially required to make, or that Angion may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;
|
|
•
|
Angion’s need and ability to hire additional personnel, including management, clinical development, medical and commercial
personnel;
|
|
•
|
the effect of competing technological, market developments and government policy;
|
|
•
|
the costs associated with being a public company, including Angion’s need to implement additional internal systems and
infrastructure, including financial and reporting systems;
|
|
•
|
the costs associated with securing and establishing commercialization and manufacturing capabilities, as well as those
associated with packaging, warehousing and distribution;
|
|
•
|
the economic and other terms, timing of and success of Angion’s existing licensing arrangements and any collaboration,
licensing or other arrangements into which Angion may enter in the future and timing and amount of payments thereunder; and
|
|
•
|
the timing, receipt and amount of sales and general commercial success of any future approved products, if any.
|
Until such time as Angion or its collaborators can generate
significant revenue from sales of product candidates, if ever, Angion expects to finance Angion’s operations through public or private equity offerings or debt financings or other sources of capital, including collaborations, licenses, credit
or loan facilities, receipt of research contributions or grants, tax credit revenue or a combination of one or more of these funding sources. Adequate funding may not be available to us on acceptable terms, or at all. To the extent Angion
raises additional capital through the sale of equity or convertible debt securities, the ownership interest of Angion’s stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences
that adversely affect the rights of Angion’s common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting Angion’s ability to take specific actions, such as
incurring additional debt, making capital expenditures or declaring dividends. If Angion raises funds through additional collaborations, or other similar arrangements with third parties, Angion may have to relinquish valuable rights to its
technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to and/or may
244
reduce the value of Angion’s common stock. If Angion is unable to raise additional
funds through equity or debt financings when needed, Angion may be required to delay, limit, reduce or terminate Angion’s product development or commercialization efforts or grant rights to develop and market Angion’s product candidates even if
Angion would otherwise prefer to develop and market such product candidates itself.
Summary Statement of Cash Flows
The following table sets forth a summary of Angion’s net cash flow
activity for the years ended December 31, 2022 and 2021 (in thousands):
|
|
| |
Year Ended December 31,
|
|||
|
|
| |
2022
|
| |
2021
|
|
|
| |
|
| |
|
|
Net cash provided by (used in)
|
| |
|
| |
|
|
Operating activities
|
| |
$(38,390)
|
| |
$(52,643)
|
|
Investing activities
|
| |
—
|
| |
(382)
|
|
Financing activities
|
| |
(60)
|
| |
107,171
|
|
Effect of foreign currency on cash
|
| |
181
|
| |
3
|
|
Net (decrease) increase in cash
|
| |
$(38,269)
|
| |
$54,149
|
Operating activities
For the year ended December 31, 2022, net cash used in operating
activities was $38.4 million, which primarily consisted of a net loss of $38.8 million and a use of cash from the change in net operating assets and liabilities of $4.2 million, partially offset by net non-cash charges of $4.6 million. The
change in net operating assets and liabilities of $4.2 million was the result of a decrease in deferred revenue of $2.3 million resulting from revenue recognized in the period, a decrease of $2.1 million in accounts payable due to the timing of
vendor payments, a decrease of $0.6 million in accrued expenses due to timing of invoices, and a decrease of $0.9 million due to lease liabilities payments. These decreases in net cash used were offset in part by a decrease of $0.8 million in
grants receivable from cash collected for the grant contract with the U.S. Department of Defense and a decrease of $0.8 million in prepaid expenses and other current assets due to suspended clinical development activities. The remaining net
fluctuations of $0.1 million were individually insignificant. The $4.6 million of net non-cash charges primarily include an impairment of $3.0 million related to Angion’s long-lived assets primarily associated with its leased facility in
Uniondale, New York, stock-based compensation of $0.9 million and amortization of operating lease right-of-use assets of $0.8 million. The remaining net non-cash charges fluctuations of $0.1 million were individually insignificant.
For the year ended December 31, 2021, net cash used in operating
activities was $52.6 million, which primarily consisted of a net loss of $54.6 million and a change in net operating assets and liabilities of $26.0 million, partially offset by net non-cash charges of $27.8 million. The net non-cash charges
were primarily related to a $14.0 million change in fair value of convertible notes, Series C convertible preferred stock and warrant liabilities, amortization of debt issuance costs of $1.9 million, and stock-based compensation expense of
$12.0 million, partially offset by a gain of $0.9 million from the forgiveness of Angion’s PPP loan. The change in net operating assets and liabilities was due to a decrease of $27.5 million in deferred revenue due to substantial satisfaction
of Angion’s performance obligation under the Vifor License Agreement, a decrease of $0.9 million in accounts payable and accrued expenses due to timing of invoices and an increase of $0.8 million in grants receivable due to the recognition of
the qualified Australian tax credit, partially offset by a decrease of $4.0 million in prepaid expenses and other current assets, primarily due to the subsequent receipt of a $5.0 million convertible note receivable under Vifor License
Agreement in 2021.
Investing activities
For the year ended December 31, 2022 no cash was provided or used
in investing activities, and for the year ended December 31, 2021, net cash used in investing activities was $0.4 million, primarily used to purchase fixed assets for research activities.
Financing activities
For the year ended December 31, 2022 net cash used in financing
activities was immaterial.
245
For the year ended December 31, 2021, net cash provided by
financing activities was $107.2 million, primarily due to net proceeds of $107.5 million from the IPO and Concurrent Private Placement, $1.8 million from the exercise of warrants and stock options, and $0.3 million from a sale and leaseback
arrangement, partially offset by taxes paid related to net share settlement upon vesting of restricted stock awards of $2.5 million.
Material Cash Requirements
Angion’s material cash requirements from known contractual
obligations consisted primarily of its lease obligations. Until March 2023 Angion continued to lease office and laboratory space in Uniondale, New York from NovaPark, a related party, under an agreement classified as an operating lease with
monthly rent expense of approximately $0.1 million pursuant to Angion’s lease agreement that was scheduled to expire on June 20, 2026.
In March 2023, Angion entered into a Surrender Agreement with
NovaPark LLC which terminated Angion’s Uniondale, New York lease for a termination fee of $3.03 million and entered into a Membership Interest Redemption Agreement with NovaPark to relinquish its 10% membership interest in NovaPark, accounted
as Investment in Related Parties in Angion’s Consolidated Balance Sheets. The Surrender Agreement also provides that no other rent or charges will be due from Angion with respect to any period prior to or subsequent to the surrender of the
property to NovaPark, thereby relieving Angion of lease payments equal to approximately $3.86 million, plus other amounts for facility fees and utilities with respect to the property.
Critical Accounting Policies and Significant Judgments and Estimates
A description of recently issued accounting pronouncements that
may potentially impact Angion’s financial position and results of operations is disclosed in Note 2 to Angion’s consolidated financial statements appearing elsewhere in this proxy statement/prospectus/information statement.
The critical accounting policies requiring estimates, assumptions,
and judgments that Angion believes have the most significant impact on Angion’s consolidated financial statements are described below.
Contract Revenue
Angion accounts for revenue earned from contracts with customers
under Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASC 606”). Under ASC 606, Angion recognizes revenue when a customer obtains control of promised goods or services, in an amount that
reflects the consideration it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of ASC 606, Angion performs the following five steps:
|
(1)
|
Identify the contract(s) with a customer;
|
|
(2)
|
Identify the performance obligations in the contract;
|
|
(3)
|
Determine the transaction price;
|
|
(4)
|
Allocate the transaction price to the performance obligations in the contract; and
|
|
(5)
|
Recognize revenue when (or as) Angion satisfies a performance obligation.
|
At contract inception, Angion assesses the goods or services
promised within each contract, whether each promised good or service is distinct, and determine those that are performance obligations. Angion then recognizes as revenue the amount of the transaction price that is allocated to the respective
performance obligation when or as the performance obligation is satisfied.
Angion enters into agreements under which it may obtain upfront
payments, milestone payments, royalty payments and other fees. Promises under these arrangements may include licenses of intellectual property, research services, including selection campaign research services for certain replacement targets,
the obligation to share information during the research and the participation of alliance managers and in joint research committees, joint patent committees and joint steering committees. Angion assesses these promises within the context of the
agreements to determine the performance obligations.
Licenses of Intellectual Property: If a license to Angion’s intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, Angion recognizes revenue from non-refundable, upfront
fees allocated to the license when the license is transferred to the customer and the customer
246
is able to use and benefit from the license. For licenses that are bundled with
other promises, Angion utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method
of measuring proportional performance for purposes of recognizing revenue from non-refundable, upfront payments. Angion evaluates the measure of proportional performance each reporting period and, if necessary, adjusts the measure of
performance and related revenue recognition.
Milestone payments: Angion evaluates whether the regulatory and development milestones are considered probable of being reached and estimates the amounts to be included in the transaction price using the most likely amount method. Angion evaluates
factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the particular milestone in making this assessment. If it is probable that a significant revenue reversal would not occur, the
associated milestone value is included in the transaction price. At the end of each reporting period, Angion re-evaluates the probability of achievement of milestones and any related constraint, and if necessary, adjusts the estimate of the
overall transaction price.
Sales-based milestones and royalties: For sales-based royalties, including milestone payments based on the level of sales, Angion determines whether the sole or predominant item to which the royalties relate is a license. When the license is the sole
or predominant item to which the sales-based royalty relates, Angion recognizes revenue at the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been
satisfied (or partially satisfied). To date, Angion has not recognized any sales-based royalty revenue resulting from any license agreement.
Deferred revenue, which is a contract liability, represents amounts received by Angion for which the related revenues has not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred
revenue represents the amount expected to be recognized within one year from the consolidated balance sheet date based on the estimated performance period of the underlying performance obligation. The noncurrent portion of deferred revenue
represents amounts expected to be recognized after one year through the end of the performance period of the performance obligation.
Using the cost-based input method, Angion recognizes revenue based
on actual costs incurred as a percentage of total estimated costs as Angion completes each performance obligation. As such, Angion uses significant assumptions to determine the total estimated costs for it to complete the performance obligation
identified under the Vifor License Agreement as well as the performance period. Angion reassesses the total estimated costs and performance period at each reporting period. See Note 3 to Angion’s consolidated financial statements included in
this proxy statement/prospectus/information statement for more information.
Grant Revenue
Angion concluded that its government grants are not within the
scope of ASC 606 as they do not meet the definition of a contract with a customer. Angion has concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and has also concluded that Subtopic 958-605,
Not-for-Profit-Entities-Revenue Recognition, does not apply, as Angion is a business entity and the grants are with governmental agencies.
In the absence of applicable guidance under GAAP, Angion developed
a policy for the recognition of grant revenue when the allowable costs are incurred and the right to payment is realized.
Angion believes this policy is consistent with the overarching
premise in ASC 606, to ensure that revenue recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that Angion expects to be entitled to in exchange for those goods or services,
even though there is no exchange as defined in ASC 606. Angion believes the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC 606.
Research and Development
Research and development costs include, but are not limited to,
payroll and personnel expenses, laboratory supplies, preclinical studies, compound manufacturing costs, consulting costs and allocated overhead, including rent, equipment, depreciation and utilities. Research and development cost may be offset
by research and development refundable tax rebates received by Angion’s wholly-owned Australian subsidiary.
Angion has agreements with various Contract Research Organizations
(“CROs”) and third-party vendors. Angion estimates research and development accruals of amounts due to the CRO based on the level of services
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performed, progress of the studies, including the phase or completion of events,
and contracted costs. Angion includes the estimated costs of research and development provided, but not yet invoiced, in accrued liabilities on the consolidated balance sheet. Angion records payments made to CROs under this arrangement in
advance of the performance of the related services as prepaid expenses and other current assets until the services are rendered. Angion makes judgments and estimates in determining the accrued liabilities balance in each reporting period. As
actual costs become known, Angion adjusts its accrued liabilities. For the years ended December 31, 2022 and 2021, Angion has not experienced any material differences between accrued costs and actual costs incurred.
Stock-Based Compensation
Angion accounts for all stock-based payments to employees and
non-employees, including grants of stock options, restricted stock awards (“RSAs”), restricted stock units (“RSUs”), including restricted stock units with non-market performance and service conditions (“PSUs”) to be recognized in the financial
statements, based on their respective grant date fair values. Angion estimates the fair value of stock option grants using the Black-Scholes option pricing model. Angion values the RSAs, RSUs and PSUs based on the fair value of its common stock
on the date of grant. The assumptions used in calculating the fair value of stock-based awards represent management's best estimates and involve inherent uncertainties and the application of management's judgment. Angion records expense for
stock-based compensation related to stock options, RSAs and RSUs over the requisite service period. As the PSUs have a performance condition, Angion recognizes compensation expense for each vesting tranche over the respective requisite service
period of each tranche if and when Angion’s management deems probable that the performance conditions will be satisfied. Angion may recognize a cumulative true-up adjustment related to PSUs once a condition becomes probable of being satisfied
if the related service period had commenced in a prior period. Angion records all stock-based compensation costs in general and administrative or research and development costs in the consolidated statements of operations based upon the
respective employee or non-employee's roles within Angion. Angion records forfeitures as they occur.
See Note 7 to Angion’s consolidated financial statements included
in this proxy statement/prospectus/information statement for more information concerning certain of the specific assumptions Angion used in applying the Black-Scholes option pricing model to determine the estimated fair value of its stock
options. Certain of such assumptions involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and Angion uses significantly different assumptions or estimates, Angion’s
stock-based compensation could be materially different.
Restructuring and Long-Lived Asset Impairment
Restructuring charges
Angion recognizes restructuring charges related to reorganization
plans that have been committed by management. In connection with these activities, Angion records restructuring charges at fair value for one-time employee termination benefits on the communication date from management to the employees provided
that management has committed to a plan of termination, the plan identifies the employees and their expected termination dates, the details of termination benefits are complete, and it is unlikely that changes to the plan will be made or the
plan will be withdrawn.
For one-time employee terminations benefits, Angion recognizes the
liability in full on the communication date when future services are not required or amortize the liability ratably over the service period, if required. The fair value of termination benefits reflects Angion’s estimates of expected utilization
of certain company-funded post-employment benefits. See Note 10 to Angion’s consolidated financial statements included in this proxy statement/prospectus/information statement for additional information on the severance expense that Angion
recognized for employees terminated in connection with its reductions in force.
Long-lived asset impairment
Long-lived assets, such as property and equipment are reviewed for
impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group to be tested for possible impairment, Angion first compares
undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized
to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including
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discounted cash flow models, quoted market values and third-party independent
appraisals, as considered necessary See Note 10 to Angion’s consolidated financial statements included in this proxy statement/prospectus/information statement for more information regarding the impairment charge Angion recorded in connection
with the long-lived assets.
Warrant Liability
Angion accounts for certain common stock warrants outstanding as a
liability, in accordance with ASC 815, at fair value and adjust the instruments to fair value at each reporting period. This liability is subject to re-measurement at each reporting period until exercised, and Angion recognizes any change in
fair value in the consolidated statements of operations as a component of other income (expense). Angion had estimated the fair value of the warrants issued by it using a variant of the Black Scholes option pricing model. Angion valued the
underlying equity included in the Black Scholes option pricing model based on the equity value implied from sales of preferred and common stock.
Income Taxes
Angion records income taxes in accordance with ASC 740, Income
Taxes (ASC 740), which provides for deferred taxes using an asset and liability approach. Angion recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated
financial statements or tax returns. Angion determines deferred tax assets and liabilities based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which
Angion expects the differences to reverse. Angion provides valuation allowances if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
Angion accounts for uncertain tax positions in accordance with the
provisions of ASC 740. When uncertain tax positions exist, Angion recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination
as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. To date, there have been no interest or penalties
charged in relation to the unrecognized tax benefits.
Recent Accounting Pronouncements
See Note 2, “Summary of Significant Accounting Policies” in the
Notes to the Consolidated Financial Statements set forth in Angion’s financial statements included in this proxy statement/prospectus/information statement for a full description of recent accounting standards.
Emerging Growth Company and Smaller Reporting
Company Status
Angion is a smaller reporting company and an emerging growth
company, as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay the adoption of new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to
private companies. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include presentation of only two years of audited financial statements in a registration statement for an initial public
offering, an exemption from the requirement to provide an auditor's report on internal controls over financial reporting pursuant to Sarbanes-Oxley Act of 2002, as amended (Sarbanes-Oxley) an exemption from any requirement that may be adopted
by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about Angion’s executive compensation arrangements. Angion has elected to use the extended transition period for complying
with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that (i) Angion is no longer an emerging growth company or (ii) Angion affirmatively and irrevocably
opts out of the extended transition period provided in the JOBS Act. As a result, Angion’s consolidated financial statements may not be comparable to companies that comply with new or revised accounting standards as of public company effective
dates.
Angion will remain an emerging growth company until the earliest
of (i) December 31, 2026, (ii) the last day of Angion’s first fiscal year in which it has total annual gross revenue of $1.235 billion or more, (iii) the date on which Angion is deemed to be a “large accelerated filer,” as defined in Rule 12b-2
under the Securities Exchange Act of
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1934, as amended (Exchange Act), which means the market value of equity securities
that is held by non-affiliates exceeds $700 million as of the last business day of Angion’s most recently completed second fiscal quarter and (iv) the date on which Angion has issued more than $1.0 billion in non-convertible debt securities
during the prior three-year period.
Even after Angion no longer qualify as an emerging growth company,
it may still qualify as a “smaller reporting company” and/or “non-accelerated filer” which may allow Angion to take advantage of many of the same exemptions from disclosure requirements including not being required to comply for a period of
time with the auditor attestation requirements of Section 404 of Sarbanes-Oxley, and reduced disclosure obligations regarding executive compensation in Angion’s periodic reports and proxy statements.
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FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
analysis of Elicio’s financial condition and results of operations together with the section titled “Unaudited Pro Forma Condensed Combined Financial Information” and Elicio’s audited consolidated financial statements and related notes for the
period ended December 31, 2022 appearing at the end of this proxy statement/prospectus/information statement. Some of the information contained in this discussion and analysis or set forth at the end of this proxy
statement/prospectus/information statement, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many
factors, including those factors set forth in the section titled “Risk Factors” our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and
analysis. You should carefully read the section titled “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled
“Cautionary Note Regarding Forward-looking Statements.”
Overview
We are a clinical-stage biotechnology company developing a
pipeline of novel immunotherapies for the treatment of cancer and other diseases. For therapies designed to engage the immune system to treat disease, it is critical to target activation at the unique location where adaptive immune responses
are generated. Our proprietary Amphiphile, or AMP, platform delivers immunotherapeutics directly to the “brain center” of the immune system - the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and
other immunomodulators will more efficiently educate, activate, and amplify critical immune cells, resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph
node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not
engage the lymph nodes.
Our operations through December 31, 2022 have been financed
primarily by aggregate net proceeds of $89.1 million from the issuance of convertible preferred stock, convertible notes, the exercise of stock options and common stock warrants. Since inception, we have had significant annual operating losses.
Our net loss was $28.2 million and $26.4 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, we had an accumulated deficit of $107.0 million and $6.2 million in cash and cash equivalents. Additionally,
as of December 31, 2022, we had current restricted cash associated with a grant in the amount of $1.6 million that is available to pay related research expenses as they are incurred over the period ending September 30, 2023.
Elicio Therapeutics, Inc. was incorporated in Delaware as Vedantra
Pharmaceuticals Inc. in August 2011. In December 2018, Elicio formed a wholly owned subsidiary, Elicio Securities Corporation, a Massachusetts corporation.
Our losses from operations, negative operating cash flows and
accumulated deficit, as well as the additional capital needed to fund operations within one year of the audited consolidated financial statement issuance date, raise substantial doubt about our ability to continue as a going concern. We expect
to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development. Our audited consolidated financial statements appearing elsewhere in
this proxy statement/prospectus/information statement have been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of
business. Our audited consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should
we be unable to continue as a going concern.
Cash used to fund operating expenses is impacted by the timing of
when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, general and
administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire
additional personnel, pay fees to outside consultants, attorneys and accountants, and, if the Merger is consummated, incur other increased costs associated with being a public company. In addition, if and when we seek and obtain regulatory
approval to
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commercialize any product candidate, we will also incur increased expenses in
connection with commercialization and marketing of any such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and
development activities. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:
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advance our lead product candidate, ELI-002 to late stage clinical trials;
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advance our other product candidates;
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advance our preclinical programs to clinical trials;
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further invest in our pipeline;
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seek regulatory approval for our investigational medicines;
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maintain, expand, protect and defend our intellectual property portfolio;
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acquire or in-license technology;
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secure facilities to support continued growth in our research, development and commercialization efforts;
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take temporary precautionary measures to help minimize the risk of COVID-19 to our employees; and
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increase our headcount to support our development efforts and to expand our clinical development team.
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We believe that our cash on hand, along with the minimum cash of
$25 million required to be delivered by Angion in the Merger, will enable us to fund our operations through calendar year 2023 based on our current plan We have based this estimate on assumptions that may prove to be wrong, and we could exhaust
our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. The Company’s losses from operations, negative operating cash flows and
accumulated deficit, as well as the additional capital needed to fund operations within one year of the audited consolidated financial statement issuance date, raise substantial doubt about the Company’s ability to continue as a going concern.
We have not had any products approved for sale. We do not expect
to generate any product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur
significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through
equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms,
if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are
unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
The COVID-19 pandemic continues to evolve. While it appears its
most severe effects have subsided, COVID-19 could re-emerge or new public health threats could appear. The future impact of the COVID-19 pandemic or a similar health disruption is highly uncertain and subject to change. We cannot predict the
full extent of potential delays or impacts on our business, our clinical trials, health care systems, third parties with whom we engage or the global economy as a whole, but if we or any of the third parties with whom we engage, including
personnel at contract manufacturing operations, or CMOs, and other third parties with whom we conduct business, were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timeline
presently planned could be materially and adversely impacted. While we have been able to continue to execute our overall business plan, some of our business activities have taken longer to complete than anticipated, particularly with respect to
the manufacture of ELI-002 in preparation for our Phase 1/2 clinical trial (AMPLIFY-201), and we continue to adjust to the challenges of operating in a largely remote setting with our employees. Overall, we recognize the challenges of product
development during a pandemic, and we will continue to closely monitor events as they develop and plan for alternative and mitigating measures if needed.
On January 17, 2023, Elicio entered into the Merger Agreement with
Angion, a clinical development corporation. The merger will result in Elicio becoming a publicly traded company. The transaction is expected to close prior to June 30, 2023.
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In conjunction with the execution of the Merger Agreement,
Elicio entered into an agreement to issue two promissory notes with a 20% discount up to an aggregate principal of $12,500,000 with interest at an annual rate of 1% in exchange for cash in an aggregate of $10,000,000. Upon the signing of the
Merger Agreement, Elicio issued the first promissory note with a principal of $6,250,000 and received cash totaling $5,000,000. Upon delivery of Elicio’s 2022 audited financial statements in March 2023, Elicio issued the second promissory note
with a principal of $6,250,000 and received cash totaling $5,000,000. Principal and accrued interest of any outstanding notes will be credited towards the net cash provided by Angion at the close of the merger or payable by Elicio if the merger
is terminated, as further detailed in the Merger Agreement.
Components of Operating Results
Operating Expenses
Our operating expenses since inception have consisted primarily of
research and development expenses and general and administrative costs.
Research and Development
Our research and development expenses consist primarily of costs
incurred for the development of our product candidates and our drug discovery efforts, which include:
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personnel costs, which include salaries, benefits and equity-based compensation expense;
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expenses incurred under agreements with consultants and contract organizations that conduct research and development
activities on our behalf;
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costs related to sponsored research service agreements;
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costs related to production of preclinical and clinical materials, including fees paid to contract manufacturers;
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laboratory and vendor expenses related to the execution of preclinical studies and planned clinical trials; and
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laboratory supplies and equipment used for internal research and development activities.
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We expense all research and development costs in the periods in
which they are incurred. Costs for certain research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and service providers.
Our research and development expenses are not currently tracked on
a program-by-program basis. We use our personnel and infrastructure resources across multiple research and development programs directed toward identifying and developing product candidates. Substantially all our research and development costs
in the years ended December 31, 2022 and 2021, were incurred on the development of ELI-002 and ELI-004, an AMP adjuvant that is a significant component of ELI-002, and our preclinical candidates. In the years ended December 31, 2022 and 2021,
we advanced several programs from discovery through preclinical development, and we advanced ELI-002 into the clinical development stage.
We expect our research and development expenses to increase
substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in conducting clinical trials, manufacturing and otherwise advancing
our programs. The process of conducting the clinical research necessary to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain.
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Because of the numerous risks and uncertainties associated with
product development and the current stage of development of our product candidates and programs, we cannot reasonably estimate or know the nature, timing and estimated costs necessary to complete the remainder of the development of our product
candidates or programs. We are also unable to predict if, when, or to what extent we will obtain approval and generate revenues from the commercialization and sale of any of our product candidates. The duration, costs and timing of preclinical
studies and clinical trials and development of our product candidates will depend on a variety of factors, including:
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successful completion of preclinical studies and initiation of clinical trials for future product candidates;
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successful enrollment and completion of clinical trials for our current product candidates;
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data from our clinical programs that support an acceptable risk-benefit profile of our product candidates in the intended
patient populations;
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acceptance by the U.S. Food and Drug Administration, or FDA, or other applicable regulatory agencies of the Investigational
New Drug, or IND, applications, clinical trial applications and/or other regulatory filings for ELI-002 and other product candidates;
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expansion and maintenance of a workforce of experienced scientists and others to continue to develop our product candidates;
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successful application for and receipt of marketing approvals from applicable regulatory authorities;
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obtainment and maintenance of intellectual property protection and regulatory exclusivity for our product candidates;
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making of arrangements with contract manufacturing organizations for, or establishment of, commercial manufacturing
capabilities;
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establishment of sales, marketing and distribution capabilities and successful launch of commercial sales of our product
candidates, if and when approved, whether alone or in collaboration with others;
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acceptance of our product candidates, if and when approved, by patients, the medical community and third-party payors;
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effective competition with other therapies;
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obtainment and maintenance of coverage, adequate pricing and adequate reimbursement from third-party payors, including
government payors;
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maintenance, enforcement, defense and protection of our rights in our intellectual property portfolio;
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avoidance of infringement, misappropriation or other violations with respect to others’ intellectual property or proprietary
rights; and
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maintenance of a continued acceptable safety profile of our products following receipt of any marketing approvals.
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We may never succeed in achieving regulatory approval for any of
our product candidates. We may obtain unexpected results from our preclinical studies and clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of
any of these factors could mean a significant change in the costs and timing associated with the development of our current and future preclinical and clinical product candidates. For example, if the FDA or another regulatory authority were to
require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies
or clinical trials, we could be required to expend significant additional financial resources and time on the completion of preclinical and clinical development.
Research and development activities account for a significant
portion of our operating expenses. We expect our research and development expenses to increase for the foreseeable future as we continue to implement our business strategy, which includes advancing ELI-002 and our other product candidates
through clinical development, expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals for our product candidates that successfully
complete clinical trials. In addition, product candidates in later stages of clinical development generally incur higher development costs
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than those in earlier stages of clinical development, primarily due to the
increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development. However, we do not believe that it
is possible at this time to accurately project total program-specific expenses through commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial
design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.
General and Administrative Expenses
Our general and administrative expenses consist primarily of
personnel costs, including equity-based compensation, and other expenses for outside professional services, including legal, recruiting, audit and accounting and facility-related costs not otherwise included in research and development
expenses. Personnel costs consist of salaries, benefits and equity-based compensation expense, for our personnel in executive and other administrative functions. We expect our general and administrative expenses to increase over the next
several years to support our continued research and development activities, manufacturing activities, increased costs of expanding our operations and operating as a public company. These increases will likely include increases related to the
hiring of additional personnel and legal, regulatory and other fees and services associated with maintaining compliance with Nasdaq Stock Market LLC, or Nasdaq, Marketplace Rules, or the Nasdaq Listing Rules and Securities and Exchange
Commission, or SEC, requirements, director and officer insurance costs and investor relations costs associated with being a public company.
Other Income/(Expense)
Our other income is comprised of interest from cash equivalents.
Our other expense is comprised of expenses related to the change
in fair value of the embedded derivative and interest accrued from the convertible notes.
Results of Operations
Comparison of the Years Ended December 31, 2022 and 2021
The following sets forth our results of operations for the years
ended December 31:
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Change
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2022
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2021
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Amount
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Percent
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Operating expenses
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Research and development
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$18,103,106
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$17,931,797
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$171,309
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1%
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General and administrative
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5,630,276
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7,542,889
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(1,912,613)
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(25%)
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Total operating expenses
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23,733,382
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25,474,686
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(1,741,304)
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(7%)
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Loss from operations
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(23,733,382)
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(25,474,686)
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(1,741,304)
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(7%)
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Other income/(expense)
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Change in fair value of embedded derivative
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(945,355)
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(52,962)
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(892,393)
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1685%
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Gain on extinguishment of convertible notes payable
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2,058
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—
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2,058
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100%
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Interest income
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64,829
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3,392
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61,437
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1811%
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Interest expense
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(3,595,838)
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(876,442)
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(2,719,396)
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(310%)
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Net loss
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$(28,207,688)
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$(26,400,689)
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$(1,806,990)
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(7%)
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Research and development expenses
Research and development expenses were $18.1 million for the year
ended December 31, 2022, compared to $17.9 million for the year ended December 31, 2021. The increase of $0.2 million was due to increases of $2.7 million in the cost of clinical activities, $1.2 million in personnel costs, and $0.9 million in
facilities and other costs, offset by decreases of $2.1 million of expenses related to contract manufacturing, $1.6 million in preclinical, and $0.9 million in allocations to grant project. Costs during the year ended December 31, 2022 directly
related to our lead product candidate, ELI-002, were $7.9 million compared to $7.3 million for the year ended December 31, 2021, an increase of $0.6 million.
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General and administrative expenses
General and administrative expenses were $5.6 million for the year
ended December 31, 2022, compared to $7.5 million for the year ended December 31, 2021. The decrease of $1.9 million was due primarily to a decrease of $2.5 million in expensing professional fees and fees associated with the abandoned IPO as
determined in August 2021, and $0.3 million in patent costs, offset by increase of $0.1 million in personnel related costs, $0.4 million in consulting costs and $0.4 million in facilities and other costs.
Other income/(expense)
Interest income for the year ended December 31, 2022 was $64,829
compared to $3,392 for the year ended December 31, 2021. The increase of $61,437 was due to higher cash balances and higher interest rates.
Interest expense for the year ended December 31, 2022 was $3.6
million compared to $0.9 million for the year ended December 31, 2021. The increase of $2.7 million was due to the interest on the outstanding Convertible Notes issued in October and November 2021.
The change in the fair value of embedded derivative for the year
ended December 31, 2022, was $0.9 million compared to $0.1 million for the year ended December 31, 2021. The increase of $0.8 million through the date of the conversion of the convertible notes was due to the change in the fair market value of
the embedded derivative for the Convertible Notes issued.
Liquidity and Capital Resources
Sources of Liquidity
Our operations through December 31, 2022 have been financed
primarily by aggregate net proceeds of $89.1 million from the issuance of convertible preferred stock, convertible notes, and the exercise of stock options and common stock warrants. Since inception, we have had significant operating losses.
Our net loss was $28.2 million and $26.4 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, we had an accumulated deficit of $107.0 million and $6.2 million in cash and cash equivalents. Our primary
use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when
we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
Our losses from operations, negative operating cash flows and
accumulated deficit, as well as the additional capital needed to fund operations within one year of the audited consolidated financial statement issuance date, raise substantial doubt about our ability to continue as a going concern. We expect
to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development. The audited consolidated financial statements appearing elsewhere in
this prospectus have been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The audited consolidated
financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going
concern.
Cash Flows
The following table summarizes our cash flows for the years ended
December 31, 2022 and 2021:
|
|
| |
Years Ended
December 31,
|
|||
|
|
| |
2022
|
| |
2021
|
|
Net cash used in operating activities
|
| |
$(22,178,766)
|
| |
$(23,939,045)
|
|
Net cash used in investing activities
|
| |
(653,836)
|
| |
(525,359)
|
|
Net cash provided by financing activities
|
| |
21,202,230
|
| |
19,393,568
|
|
Net (decrease) in cash, cash equivalents, and restricted cash
|
| |
$(1,630,372)
|
| |
$(5,070,836)
|
256
Net Cash Used in Operating Activities
Net cash used in operating activities of $22.2 million during the
year ended December 31, 2022 was attributable to our net loss of $28.2 million and source of cash of $0.5 million resulting from the change in operating assets and liabilities, partially offset by non-cash charges of $5.5 million, principally
with respect to $3.6 million of non-cash interest expense, $0.9 million of non-cash change in fair value of embedded derivative, $0.4 million of depreciation expense, and $0.6 million of stock based compensation expense.
Net cash used in operating activities of $23.9 million during the
year ended December 31, 2021 was attributable to our net loss of $26.4 million and source of cash of $0.9 million resulting from the change in operating assets and liabilities, partially offset by non-cash charges of $1.6 million, principally
with respect to $0.7 million of non-cash interest expense, $0.3 million of depreciation expense, and $0.6 million of stock based compensation expense.
Net Cash Used in Investing Activities
Net cash used in investing activities in the years ended December
31, 2022 and 2021 of $0.7 million and $0.5 million, respectively, was comprised of purchases of capital equipment.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the year ended
December 31, 2022 was $21.2 million, comprised of $21.1 million of net proceeds from the issuance of Series C Preferred Stock and $0.1 million of proceeds from the exercise of common stock options.
Net cash provided by financing activities for the year ended
December 31, 2021 was $19.4 million, comprised of $4.9 million net proceeds from the issuance of Series B Preferred, $14.5 million proceeds from the issuance of Convertible Notes, $0.2 million from the settlement of a note receivable and
$0.2 million of exercise of common stock warrants, common stock options, and the issuance of common stock, offset by $0.4 million in issuance costs for the convertible notes.
Funding Requirements
Any product candidates we may develop may never achieve
commercialization, and we anticipate that we will continue to incur losses for the foreseeable future. We expect that our research and development expenses, general and administrative expenses, and capital expenditures will continue to
increase. As a result, until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings or other capital sources, including potential
collaborations, licenses and other similar arrangements. Our primary uses of capital are, and we expect will continue to be, costs related to clinical research, manufacturing and development services; compensation and related expenses; costs
relating to the build-out of our headquarters, other offices and laboratories; license payments or milestone obligations that may arise; laboratory expenses and costs for related supplies; manufacturing costs; legal and other regulatory
expenses and general overhead costs.
We believe that our cash on hand, along with the minimum cash of
$25 million required to be delivered by Angion in the Merger, will enable us to fund our operations through calendar year 2023 based on our current plan to finance our operations beyond that point, we will need to raise additional capital,
which cannot be assured. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. We will continue to require additional financing to advance
our current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. We will continue to seek funds through equity offerings, debt
financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at
all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders, including investors in this offering, will be diluted, and the terms of these securities may include
liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as
incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and
strategies. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
257
Because of the numerous risks and uncertainties associated with
research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited
to:
|
•
|
the impacts of the COVID-19 pandemic;
|
|
•
|
the progress, costs and results of our ongoing Phase 1/2 clinical trial of ELI-002 (AMPLIFY-201) and our potential future
clinical trials for our other product candidates;
|
|
•
|
the scope, progress, results and costs of discovery research, preclinical development, laboratory testing and clinical trials
for our other product candidates;
|
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
|
•
|
our ability to enter into contract manufacturing arrangements for supply of active pharmaceutical ingredient, or API, and
manufacture of our product candidates and the terms of such arrangements;
|
|
•
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of
such arrangements;
|
|
•
|
the payment or receipt of milestones and receipt of other collaboration-based revenues, if any;
|
|
•
|
the costs and timing of any future commercialization activities, including product manufacturing, sales, marketing and
distribution, for any of our product candidates for which we may receive marketing approval;
|
|
•
|
the amount and timing of revenue, if any, received from commercial sales of our product candidates for which we receive
marketing approval;
|
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual
property and proprietary rights and defending any intellectual property-related claims;
|
|
•
|
the extent to which we acquire or in-license other products, product candidates, technologies or data referencing rights;
|
|
•
|
the ability to receive additional non-dilutive funding, including grants from organizations and foundations; and
|
|
•
|
the costs of operating as a public company.
|
Further, our operating plans may change, and we may need
additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our
product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.
Critical Accounting Policies and Use of Significant Judgments and
Estimates
Our management’s discussion and analysis of our financial
condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these consolidated financial
statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the
reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies
discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
Going Concern
Our evaluation of our ability to continue as a going concern
requires us to evaluate our future sources and uses of cash sufficient to fund our currently expected operations in conducting research and development activities one
258
year from the date our audited consolidated financial statements are issued. We
evaluate the probability associated with each source and use of cash resources in making our going concern determination. The research and development of pharmaceutical products is inherently subject to uncertainty.
Research and Development Costs
We will incur substantial expenses associated with manufacturing
and clinical trials. Accounting for clinical trials relating to activities performed by contract research organizations, or CROs, and other external vendors requires management to exercise significant estimates in regard to the timing and
accounting for these expenses. We estimate costs of research and development activities conducted by service providers, which include the conduct of sponsored research, preclinical studies and contract manufacturing activities. The diverse
nature of services being provided under CROs and other arrangements, the different compensation arrangements that exist for each type of service and the lack of timely information related to certain clinical activities complicates the
estimation of accruals for services rendered by CROs and other vendors in connection with clinical trials. We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet
invoiced and include these costs in the accrued expenses or prepaid expenses on the balance sheets and within research and development expense on the consolidated statements of operations. In estimating the duration of a clinical study, we
evaluate the start-up, treatment and wrap-up periods, compensation arrangements and services rendered attributable to each clinical trial and fluctuations are regularly tested against payment plans and trial completion assumptions.
We estimate these costs based on factors such as estimates of the
work completed and budget provided and in accordance with agreements established with our collaboration partners and third-party service providers. We make significant judgments and estimates in determining the accrued liabilities and prepaid
expense balances in each reporting period. As actual costs become known, we adjust our accrued liabilities or prepaid expenses. We have not experienced any material differences between accrued costs and actual costs incurred since our
inception.
Our expenses related to clinical trials will be based on estimates
of patient enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that may be used to conduct and
manage clinical trials on our behalf. We will accrue expenses related to clinical trials based on contracted amounts applied to the level of patient enrollment and activity. If timelines or contracts are modified based upon changes in the
clinical trial protocol or scope of work to be performed, we will modify our estimates of accrued expenses accordingly on a prospective basis.
Fair market value of common stock
As there has been no public market for the Common Stock, the
estimated fair value of the Common Stock has been determined by Elicio’s Board of Directors as of the date of each option grant, with input from management, considering Elicio's most recently available third-party valuations of Common Stock and
its Board of Directors' assessment of additional objective and subjective factors it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. These third-party valuations were
performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants' Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The Common Stock
valuations were prepared using the option pricing method. These third-party valuations were performed at various dates, which resulted in valuations of the Common Stock of $0.25 per share as of August 31, 2021 and $0.07 per share as of
October 18, 2022.
Leases
ASU No. 2016-02, Leases (ASC 842) establishes a right-of-use model
(ROU) that requires a lessee to recognize a ROU asset and corresponding lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the
pattern and classification of expense recognition in the unaudited statement of operations as well as the reduction of the right of use asset.
At the inception of an arrangement, Elicio determines whether the
arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and Elicio’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their
corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, Elicio will utilize the
incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
259
Elicio has elected to combine lease and non-lease components as
a single component. Operating leases are recognized on the consolidated balance sheet as ROU lease assets, current lease liabilities and non-current lease liabilities. Fixed rents are included in the calculation of the lease balances, while
variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis.
Stock-based Compensation
Prior to the proposed Merger, we issued equity-based compensation
awards through the granting of options, which generally vest over four years. We account for equity-based compensation in accordance with Accounting Standards Codification, or ASC, 718, Compensation-Stock
Compensation, or ASC 718. In accordance with ASC 718, compensation cost is measured at estimated fair value at grant date and is included as compensation expense over the vesting period during which service is provided in exchange for
the award. Compensation cost of awards that contain a performance condition are recognized when success is considered probable during the performance period.
We use the Black-Scholes option pricing model, or Black-Scholes,
to determine fair value of our options. Black-Scholes includes various assumptions, including the fair value of common shares, expected life of incentive shares, the expected volatility and the expected risk-free interest rate. These
assumptions reflect our best estimates, but they involve inherent uncertainties based on market conditions generally outside our control. As a result, if other assumptions had been used, equity-based compensation cost could have been materially
impacted. Furthermore, if we use different assumptions for future grants, equity-based compensation cost could be materially impacted in future periods.
The risk-free interest rate is estimated using the weighted
average rate of return on U.S. Treasury notes with a life that approximates the expected life of the option. The expected term of options granted to employees was calculated using the simplified method, which represents the average of the
contractual term of the option and the weighted-average vesting period of the option. Elicio uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate
expected term. The contractual life of the option was used for the expected life of options granted to non-employees. Expected volatility is based on the weighted average of the historical volatility of a peer group of publicly traded
companies. The assumed dividend yield is based upon Elicio's expectation of not paying dividends in the foreseeable future.
We granted stock options to purchase 38,551,352 shares of common
stock during the year ended December 31, 2022. The fair value of our awards in the year ended December 31, 2022 has been estimated using Black-Scholes based on the following assumptions: term of 5.5-10.0 years; volatility of 60.3-73.2%;
risk-free rate of 1.64-3.88%; and no expectation of dividends.
We granted stock options to purchase 2,970,308 shares of common
stock in the year ended December 31, 2021. The fair value of ourawards in the year ended December 31, 2021 has been estimated using Black-Scholes based on the following assumptions: term of 6.08-10.0 years; volatility of 64.0-66.0%; risk-free
rate of 0.59-1.54%; and no expectation of dividends.
We will continue to use judgment in evaluating the assumptions
utilized for our equity-based compensation expense calculations on a prospective basis. In addition to the assumptions used in the Black-Scholes model, the amount of equity-based compensation expense we recognize in our consolidated financial
statements includes incentive share forfeitures as they occurred.
As there has been no public market for our common shares to date,
our board of directors, with input from management, has determined the estimated fair value of our common shares as of the date of each incentive share grant considering our then-most recently available third-party valuation of common shares.
Valuations are updated when facts and circumstances indicate that the most recent valuation is no longer valid, such as changes in the stage of our development efforts, various exit strategies and their timing, and other scientific developments
that could be related to the valuation of our company, or, at a minimum, annually. Third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and
Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation.
The estimates of fair value of our common stock are highly complex
and subjective. There are significant judgments and estimates inherent in the determination of the fair value of our common shares. These judgments and estimates include assumptions regarding our future operating performance, the time to
completing a liquidity event, the related valuations associated with these events, and the determinations of the appropriate valuation methods at
260
each valuation date. The assumptions underlying these valuations represent our
best estimates, which involve inherent uncertainties and the application of management judgment. If we had made different assumptions, our equity-based compensation expense, net loss and net loss per share applicable to common stockholders
could have been materially different.
Following the completion of this Merger, we intend to determine
the fair value of our common stock based on the closing price of our common stock as reported by Nasdaq on the date of grant.
The following table details equity-based awards that we granted
and awarded in the years ended December 31, 2022 and 2021:
|
Grant Date
|
| |
Type of Award
|
| |
Number of
Shares
Subject to
Awards
Granted
|
| |
Per Share
Exercise
Price
|
| |
Estimate of
Common
Share Fair
Value Per
Share on
Grant Date
|
|
February 1, 2021
|
| |
Stock Option
|
| |
1,956,166
|
| |
0.23
|
| |
0.23
|
|
March 11, 2021
|
| |
Restricted Stock Units
|
| |
839,142
|
| |
—
|
| |
0.23
|
|
March 11, 2021
|
| |
Stock Option
|
| |
150,000
|
| |
0.23
|
| |
0.23
|
|
March 11, 2021
|
| |
Stock Option
|
| |
25,000
|
| |
0.23
|
| |
0.23
|
|
January 16, 2022
|
| |
Stock Option
|
| |
640,000
|
| |
0.25
|
| |
0.25
|
|
January 16, 2022
|
| |
Stock Option
|
| |
25,000
|
| |
0.25
|
| |
0.25
|
|
March 31, 2022
|
| |
Stock Option
|
| |
2,605,000
|
| |
0.25
|
| |
0.25
|
|
March 31, 2022
|
| |
Stock Option
|
| |
525,000
|
| |
0.25
|
| |
0.25
|
|
November 28, 2022
|
| |
Stock Option
|
| |
26,950,891
|
| |
0.07
|
| |
0.07
|
|
December 6, 2022
|
| |
Stock Option
|
| |
7,805,467
|
| |
0.07
|
| |
0.07
|
Derivative Financial Instruments
The convertible notes include an embedded derivative requiring
bifurcation in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging. The valuation of this instrument is determined using widely accepted valuation technique including the probability weighted expected return
model. The fair value was determined using a model with the assumptions for equity value proceeds, probability of occurrence of various liquidation scenarios, timeline to liquidity and risk-free interest rate. The fair value of this derivative
instrument is measured at each reporting period with changes in fair value reported in earnings. On October 18, 2022, in conjunction with the shares of Series C preferred Stock issued on this same date, the Convertible Notes Payable totaling
$14,470,000 and the related accrued interest totaling $1,131,952 automatically converted into 75,700,879 shares of Series C Preferred Stock at an 80% discount to the Series C Preferred Stock issuance price per share of $0.2576, or $0.2061 per
share. Just prior to settlement, the fair value of the embedded derivative was marked to market a final time to the aggregate value of $3,900,652. Elicio recorded a gain on extinguishment totaling $2,058 related to the difference in the total
of Convertible Notes Payable, total accrued interest and the final fair value of the embedded derivative versus the value of the Series C Preferred Stock shares issued based on the original issuance price of $0.2576.
Recently Adopted Accounting Pronouncements
A description of recently issued accounting pronouncements that
may potentially impact our financial position and results of operations is disclosed in the notes to our consolidated financial statements appearing elsewhere in this prospectus.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations as of
December 31, 2022:
|
|
| |
Payments due by period
|
||||||||||||
|
|
| |
Total
|
| |
Less than
one year
|
| |
One to
two years
|
| |
Three to
four years
|
| |
Five and
more years
|
|
Leases
|
| |
$9,952,866
|
| |
$1,265,883
|
| |
$2,646,787
|
| |
$2,808,032
|
| |
$3,232,164
|
|
Total contractual obligations
|
| |
$9,952,866
|
| |
$1,265,883
|
| |
$2,646,787
|
| |
$2,808,032
|
| |
$3,232,164
|
261
We enter into contracts in the normal course of business with
third-party service providers for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. We have not included our payment obligations under these contracts in the table
as these contracts generally provide for termination upon notice, and therefore, we believe that our non-cancelable obligations under these agreements are not material and we cannot reasonably estimate the timing of if and when they will occur.
We could also enter into additional research, manufacturing, supplier and other agreements in the future, which may require up-front payments and even long-term commitments of cash.
In January 2016, we licensed certain intellectual property from
Massachusetts Institute of Technology, or MIT, on terms that have been amended from time to time. The license term for both licenses extends until terminated by either party under certain provisions. We are required to pay certain contractual
maintenance and milestone payments related to clinical trials and royalties on product sales over the term of the contract, with minimum annual royalty payments commencing in the calendar year after commercialization.
Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Risk
As of December 31, 2022, our cash consists of cash held as
deposits at a major financial banking institution and highly liquid investments with an original maturity of three months or less at the date of purchase. As a result, the fair value of our portfolio is relatively insensitive to interest rate
changes. As of December 31, 2022, we had no variable-rate debt outstanding and are therefore not exposed to interest rate risk with respect to debt. We believe a hypothetical 100 basis point increase or decrease in interest rates during the
period presented would not have had a material impact on our financial results.
Foreign Currency Risk
All of our employees and our operations are currently located in
the United States and our expenses are generally denominated in U.S. dollars. We believe a hypothetical 100 basis point increase or decrease in exchange rates during the period presented would not have had a material impact on our financial
results.
Effects of Inflation
We believe that inflation and changing prices have had a moderate
impact on our results of operations for the period presented herein.
262
The following table provides information regarding the expected
directors and executive officers of the combined company following the closing of the Merger:
|
Name
|
| |
Age
|
| |
Position
|
|
Robert Connelly
|
| |
63
|
| |
Chief Executive Officer, President and Class I Director
|
|
Daniel Geffken
|
| |
66
|
| |
Interim Chief Financial Officer
|
|
Christopher Haqq, M.D., Ph.D.
|
| |
57
|
| |
Executive Vice President, Head of Research and Development
and Chief Medical Officer
|
|
Annette Matthies, Ph.D.
|
| |
46
|
| |
Chief Business Officer
|
|
Peter DeMuth, Ph.D.
|
| |
37
|
| |
Chief Scientific Officer
|
|
Julian Adams, Ph.D.
|
| |
68
|
| |
Class III Director and Chair
|
|
Jay R. Venkatesan, M.D.
|
| |
51
|
| |
Class III Director
|
|
Carol Ashe
|
| |
65
|
| |
Class III Director
|
|
Yekaterina (Katie) Chudnovsky
|
| |
38
|
| |
Class I Director
|
|
Robert R. Ruffolo, Jr., PhD, FCPP
|
| |
73
|
| |
Class II Director
|
|
Assaf Segal
|
| |
51
|
| |
Class II Director
|
|
Karen J. Wilson
|
| |
60
|
| |
Class II Director
|
|
Allen R. Nissenson, M.D.
|
| |
76
|
| |
Class I Director
|
Robert Connelly has served as Elicio’s Chief Executive Officer and as a member of Elicio’s Board since October 2018. Mr. Connelly has nearly 40 years of experience in the life sciences sector in leadership and operational roles. From 2013 to 2018,
Mr. Connelly served as the CEO and as a member of the board of Axcella Health Inc. (Nasdaq: AXLA), a clinical-stage therapeutics company developing endogenous modulators of metabolism to treat an array of diseases. Prior to Axcella,
Mr. Connelly served as the founding CEO of WikiCell Designs and the Chairman of Aero Designs, each utilizing drug delivery technologies to create new food, beverage and supplement product, both of which merged into Incredible Foods in 2013.
Prior to that, Mr. Connelly served as the CEO of Pulmatrix, Inc. (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing inhaled therapies to address pulmonary diseases, from 2007 to 2012. From 2000 to 2007, Mr. Connelly served
as the founding CEO and first employee of Domantis Ltd., a U.K.-based biotechnology company, which was acquired by GlaxoSmithKline plc. He began his career with life science companies Abbott Laboratories (NYSE: ABT) and BioVeris Corp (Nasdaq:
IGEN) in positions of increasing responsibility. Mr. Connelly previously served on the boards of publicly traded life science companies Kaleido Biosciences, Inc. (Nasdaq: KLDO) from 2015 to 2018 and Anchiano Therapeutics Ltd. (Nasdaq: ANCN)
from 2018 to 2019, as well as on the boards of several privately held biopharmaceutical companies. He also served as a Venture Partner with Flagship Pioneering from 2013 to 2018, working on the creation and management of several biotechnology
portfolio companies. Mr. Connelly received a B.S. in Business Administration from the University of Florida.
Daniel Geffken has served as Elicio’s Interim Chief Financial Officer since 2013 and as a member of Elicio’s Board since 2017. Mr. Geffken is a founder and managing director at Danforth Advisors, LLC, a management consulting firm to the life
science industries, where he has served since 2011. Mr. Geffken brings more than 30 years of extensive experience with both publicly-traded and privately-held companies. Through Danforth, Mr. Geffken has served as CFO for ProMIS Neurosciences
(TSX: PMN; OTCQB: ARFXF), a biotechnology company focused on the development of therapeutics for neurodegenerative diseases, since March 2017, and Locust Walk Acquisition Corp. (Nasdaq: LWAC) since October 2020 until its merger with eFFECTOR
Therapeutics, Inc. in August 2021, and as interim CFO for Eloxx Pharmaceuticals, Inc. (Nasdaq: ELOX), a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates, since April 2021. He also currently consults
with various life sciences companies, including Prilenia Therapeutics Development Corp., Apic Bio Inc., Clear Creek Bio, Inc., Dermbiont, Inc., and Calcimedica Inc. Since 2019, Mr. Geffken has been a member of the board of directors of
Windtree Therapeutics (Nasdaq: WINT), a biopharmaceutical company, and from May 2013 to October 2017, he was a member of the board of directors of Alcobra Ltd., a publicly traded biotechnology company that merged with Arcturus Therapeutics,
Inc. (Nasdaq: ARCT). From November 2017 until May 2018, Mr. Geffken served on the board of directors of Arcturus. Mr. Geffken holds a B.S. in Economics from The Wharton School, University of Pennsylvania, and an M.B.A. from Harvard Business
School.
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Christopher Haqq, M.D., Ph.D. has served as Elicio’s Executive Vice President, Head of Research and Development and Chief Medical Officer since October 2019. Dr. Haqq brings over 20 years of drug development leadership experience at both large
and small biotechnology companies. From 2017 to 2019, Dr. Haqq served as the Executive Vice President and CSO of Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a biotechnology company focused on T-cell immunotherapy, where he previously served
as the first CMO from 2012 to 2017. From 2007 to 2011, Dr. Haqq was the lead medical monitor for the pivotal trial leading to marketing approval for Zytiga® at Cougar Biotechnology, Inc., a cancer-focused biotechnology company that was
acquired by Johnson & Johnson (NYSE: JNJ) in 2009. Prior to that time, Dr. Haqq served in drug development roles at Amgen Inc. (Nasdaq: AMGN), a biotechnology company, and practiced as a medical oncologist and led a translational science
laboratory as an Assistant Adjunct Professor in the Division of Hematology/Oncology at the University of California, San Francisco. Dr. Haqq received a B.S. from Stanford University and an M.D. and a Ph.D. from Harvard Medical School.
Annette M. Matthies, Ph.D. has served as Elicio’s Chief Business Officer since January 2021. Dr. Matthies brings nearly 20 years of biotechnology experience in corporate strategy, business development, new product planning, and private and
public fund raising. From 2016 to 2019, Dr. Matthies served as the Vice President of Corporate Development at eFFECTOR Therapeutics, Inc., a biopharmaceutical company focused on new treatments for cancer, where she led business development
activities. Prior to eFFECTOR, Dr. Matthies served as the Senior Director of Corporate Development at Receptos, Inc., which was subsequently acquired by Celgene Corporation, from 2012 to 2015. From 2010 to 2011, Dr. Matthies served as
Associate Director of New Product Planning at Abbott Laboratories (NYSE: ABT) following the acquisition of Facet Biotech Corporation, in a post-acquisition integration role to transition new product planning practices to Abbott’s newly formed
Global Strategy, Marketing and Services team. Prior to Abbott, she held positions of increasing responsibility in business development and market research at Facet Biotech and Biogen Inc. (Nasdaq: BIIB). Dr. Matthies began her career as a
strategy consultant in the Life Sciences practice of L.E.K. Consulting. She received a B.A. in Biology from Augustana College and a Ph.D. in Immunology, Microbiology and Virology at Loyola University and completed a post-doctoral fellowship
in bioengineering at the Swiss Federal Institute of Technology, ETH Zurich and EPFL.
Peter DeMuth, Ph.D. has served as Elicio’s Chief Scientific Officer since January 2022. Dr. DeMuth brings over 15 years of biotechnology experience in oncology, immunology and materials science. From June 2013 to August 2017, Dr. DeMuth served as a
Scientist at Elicio. In late 2017, Dr. DeMuth began to hold roles of increasing responsibility at Elicio, where he served as Director of Research from August 2017 to November 2018, and then as Vice President of Research from November 2018 to
January 2022, prior to his current role as Chief Scientific Officer. Prior to joining Elicio, Dr. DeMuth oversaw efforts to develop novel technologies for vaccine delivery at the Massachusetts Institute of Technology’s Koch Institute for
Integrative Cancer Research in affiliation with the Ragon Institute of Massachusetts General Hospital, MIT, and Harvard University, where he received recognition from the National Science Foundation, the American Chemical Society, and the
Thomas and Stacy Siebel Foundation. In 2015, Dr. DeMuth received the Quadrant Award from Quadrant AG, a global manufacturer and innovator in polymer materials science, for research he completed while at the Koch Institute at MIT. Dr. DeMuth
has also been an NIH Fellow at the Whitehead Institute for Biomedical Research and a research fellow at Novartis Vaccines and Diagnostics. As a Howard Hughes Research Fellow at the University of Maryland, he was awarded the University Medal
for his development of advanced technologies for oncology therapeutics. Dr. DeMuth received a B.S. in Chemical Engineering and B.S. in Biochemistry from the University of Maryland, College Park in 2008, and a Ph.D. in Biological Engineering
from the Massachusetts Institute of Technology in 2013.
Jay R. Venkatesan, M.D. See “Angion Directors, Officers and Corporate Governance—Executive Officers and Employee Directors” for Dr. Venkatesan’s biography.
Julian Adams, Ph.D. served as Chairman of the Elicio Board since 2017. Dr. Adams was previously the Chief Executive Officer of Gamida Cell Ltd (Nasdaq: GMDA), a clinical-stage biopharmaceutical company working to develop cell therapies for hematologic
cancers and rare, serious hematologic diseases, from November 2017 to November 2022. Prior to Gamida Cell, Dr. Adams was President and CSO at Clal Biotechnology Industries, or CBI (TASE: CBI), from January 2017 to November 2017. Before
joining CBI, Dr. Adams served as President of Research and Development at Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) from 2003 to 2017, and also as its CSO from 2006 to 2010 where he built and led the company’s R&D efforts. From 1999
to 2003, Dr. Adams served as Senior Vice President, Drug Discovery and Development at Millennium Pharmaceuticals, Inc., now part of Takeda Pharmaceutical Company Limited, where he played a key role in the discovery of Velcade® (bortezomib), a
therapy
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widely used for treatment of the blood cancer, multiple myeloma. Earlier in his
career, he was credited with discovering Viramune® (nevirapine) for HIV at Boehringer Ingelheim. He has also held senior leadership roles in research and development at LeukoSite, Inc. and ProScript. Dr. Adams previously served on the board of
Pieris Pharmaceuticals, Inc. (Nasdaq: PIRS) from 2016 to 2018 and Neon Therapeutics, Inc., now BioNTech SE (Nasdaq: BNTX) from 2017 to 2018. Dr. Adams earned a B.S. from McGill University, where he also was awarded an honorary Sc.D, and a Ph.D.
from the Massachusetts Institute of Technology.
Carol Ashe
served as a member of the Elicio Board since August 2020. Ms. Ashe has been the CBO at the New York Genome Center, an independent, non-profit academic research institution focused on the advancement of genomic science and its application to
drive novel biomedical discoveries with particular focus in the areas of neurodegenerative disease, neuropsychiatric disease, and cancer, since 2014. Previously, she served as Vice President of Corporate Development for Endo Pharmaceuticals’
(Nasdaq: ENDP) branded, generic and platform drug delivery pharmaceutical business units from 2011 to 2013; a Partner at SR One, the corporate venture capital fund of GlaxoSmithKline (NYSE:GSK), or GSK, from 2008 to 2010; and head of GSK’s US
Corporate Legal Group supporting US-based mergers, acquisitions and equity investments from 2007 to 2008. Prior to that, Ms. Ashe led GSK’s global Business Development Transactions Legal Team supporting both the pharmaceutical and consumer
healthcare business units for many years until 2007. She has served on the board of Aptose Biosciences Inc. (TSX: APS, Nasdaq: APTO), a clinical stage biotechnology company, since 2018. Ms. Ashe received a B.S. in Biology from Pennsylvania
State University, a J.D. from Villanova University School of Law and is a registered patent attorney.
Yekaterina (Katie) Chudnovsky served as a member of the Elicio Board since October 2022. Since 2009, Ms. Chudnovsky has served as General Counsel for an international privately-held technology firm, overseeing intellectual property,
trademarks, technology acquisition, and mergers & acquisitions. Ms. Chudnovsky is Chairperson of the GI Research Foundation (GIRF) for the University of Chicago Digestive Diseases Center. She has served on the GIRF board for the past 11
years, becoming President in 2019. Her work with GIRF contributes to raising over $3 million annually to support the physicians and scientists at the University of Chicago and beyond. Ms. Chudnovsky is an active Board member of XCures, a
privately-held technology company working to advance cancer research and patient outcomes. Ms. Chudnovsky has a particular interest in cancer research and personalized cancer vaccines, and is a frequent investor and donor in the space. Prior
to her current roles, she began her legal career at Thomas Coburn Fagel Haber, with a focus on corporate law, real estate, mergers and acquisitions, bankruptcy, and business banking. Ms. Chudnovsky received a B.A. in political science and
Slavic literature from Northwestern University, and a J.D. from DePaul University.
Robert R. Ruffolo, Jr., Ph.D. served as a member of the Elicio Board since 2018. Dr. Ruffolo has operated Ruffolo Consulting, LLC, a consulting firm advising large pharmaceutical and biotechnology companies, since 2008. Previously, Dr.
Ruffolo served as President of Research and Development and as Corporate Senior Vice President of Wyeth Pharmaceuticals Inc. (now Pfizer Inc. (NYSE: PFE)) from 2002 through 2008. From 2000 to 2002 he served as an Executive Vice President at
Wyeth Pharmaceuticals, where he was responsible for Pharmaceutical Research and Development. Prior to joining Wyeth Pharmaceuticals, Dr. Ruffolo spent 17 years at SmithKline Beecham Pharmaceuticals plc (now GlaxoSmithKline plc (NYSE:GSK))
where he was Senior Vice President and Director of Biological Sciences, Worldwide from 1984 to 2000. Before joining SmithKline Beecham Pharmaceuticals plc, Dr. Ruffolo spent six years at Eli Lilly and Company (NYSE: LLY) from 1978 to 1984
where he was Chairman of the Cardiovascular Research Committee. Dr. Ruffolo currently serves on the boards of directors of Sigilon Therapeutics, Inc. (Nasdaq: SGTX) and several private companies. He received a B.S. in Pharmacy and a Ph.D. in
Pharmacology from The Ohio State University.
Assaf Segal
has served as a member of the Elicio Board since June 2022. Mr. Segal has served, since July 2022, as the Chief Executive Officer at Clal Biotechnology (“CBI”), a publicly traded life sciences investment company. Mr. Segal serves as a board
member of several companies, including Biokine therapeutics Ltd., eXIthera Pharmaceuticals Inc., MediWound Ltd. (Nasdaq: MDWD), Colospan Ltd., FDNA Inc., and Clal Life Sciences L.P. Mr. Segal served as Chief Financial Officer of CBI from July
2015 until June 2022. Prior to that time, Mr Segal was a Partner at Variance Economic Consulting Ltd., from 2004 until June 2015, where he provided in-depth consulting for international and local clients in a wide range of industries,
including telecommunications, internet, medical technologies, biotech, and financial sectors. Previously, Mr. Segal held a managerial position at PriceWaterhouseCoopers Corporate Finance and was an Economic Department manager at the North
American division of Amdocs Inc. (NYSE: DOX). His experience also includes risk management and house account (Nostro)
265
trading at the Union Bank of Israel and serving as an economist for capital
markets in the Research Department of the Bank of Israel. Mr. Segal also has many years of experience in economic consulting and company valuations, joint ventures and financial instruments for investments, M&A, and IPOs. He has over 20
years of experience in economic consulting for international organizations in the Bio-Tech sector as well as in Hi-Tech, financial and other sectors. Mr. Segal is a co-founder of Nextrade Ltd., which earned over $20M annual revenues and grew to
120 employees, and Solid Capital, a financial software start-up company. Mr. Segal holds a B.A. in Economics and Statistics and an M.B.A. (Finance and Information Systems) from the Hebrew University of Jerusalem.
Karen Wilson
has been a member of Angion's Board since April 2020. Ms. Wilson is also currently a member of the boards of directors of Connect Biopharma, and LAVA Therapeutics. Ms. Wilson also served as a member of the board of directors of Vaxart, Inc.
between August 2020 to August 2022. Ms. Wilson previously served as Senior Vice President of Finance at Jazz Pharmaceuticals plc, a biopharmaceutical company, until September 2020 after serving as Principal Accounting Officer and Vice
President of Finance. Prior to joining the Jazz Pharmaceuticals organization in February 2011, she served as Principal Accounting Officer and Vice President of Finance at PDL BioPharma, Inc., a life sciences company. She also previously
served as a Principal at the consulting firm of Wilson Crisler LLC, Chief Financial Officer of ViroLogic, Inc., a biosciences company, Chief Financial Officer and Vice President of Operations for Novare Surgical Systems, Inc., a medical
device manufacturer, and as a consultant and auditor for Deloitte & Touche LLP, a professional services firm. Ms. Wilson is a Certified Public Accountant and received a B.S. in Business from the University of California, Berkeley. Angion
believes that Ms. Wilson is qualified to serve on Angion's Board due to her extensive background in financial and accounting matters for public companies and her leadership experience in the life science industry.
Allen R. Nissenson, M.D., has been a member of Angion's Board since January 2020. He completed serving as the Emeritus Chief Medical Officer of DaVita Kidney Care in January 2022, where he has served since January 2020 and where he
previously served as Chief Medical Officer from August 2008 to January 2020. He is currently an Emeritus Professor of Medicine at the David Geffen School of Medicine at UCLA, where he has served since August 2008 and where he previously
served as Director of the Dialysis Program from July 1977 to August 2008 and Associate Dean from July 2005 to August 2008. Dr. Nissenson is also currently on the board of directors of Rockwell Medical Inc., a public biopharmaceutical company,
which he joined in June 2020 and Diality, a private technology development company. Dr. Nissenson is a past chair of Kidney Care Partners and past co-chair of the Kidney Care Quality Alliance. He is a former president of the Renal Physicians
Association (RPA) and current member of the Government Affairs Committee. Dr. Nissenson also previously served as president of the Southern California End-Stage Renal Disease Network, as well as chair of the Medical Review Board. He served as
a Robert Wood Johnson Health Policy Fellow of the National Academy of Medicine from 1994 to 1995 and worked in the office of the late Senator Paul Wellstone. Dr. Nissenson has an M.D. from Northwestern University Medical School and is the
recipient of various awards, including the President's Award of the National Kidney Foundation, the Lifetime Achievement Award in Hemodialysis, the American Association of Kidney Patients' (AAKP) Medal of Excellence Award and, in 2017, the
RPA Distinguished Nephrology Service Award. Angion believes that Dr. Nissenson's years of experience in the healthcare industry qualify him to serve as a member of Angion's Board.
There are no family relationships among any of Angion’s current
directors and executive officers, and there are no family relationships among any of the combined company’s proposed directors and executive officers.
Angion’s Board is divided into three classes. Each class has a
three-year term. Vacancies on the board of directors may be filled only by a majority of the directors then in office. A director elected by the Board of Directors to fill a vacancy in a class, including vacancies created by an increase in the
number of directors, shall serve for the remainder of the full term of that class and until the director’s successor is duly elected and qualified.
Pursuant to the Merger Agreement, each of the directors and
officers of Angion who will not continue as directors or officers of the combined company following the completion of the Merger shall resign immediately prior to the Effective Time. Pursuant to the terms of the Merger Agreement, following the
completion of the Merger, the Combined Company Board will consist of nine directors, which will be comprised of six members designated by Elicio and three members designated by Angion.
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It is anticipated that these directors will be appointed to the three staggered
director classes of the Combined Board as follows:
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Class I directors (expiring in 2024): Ms. Chudnovsky and Messrs. Nissenson and Connelly;
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Class II directors (expiring in 2025): Dr. Ruffolo, Mr. Segal and Ms. Wilson; and
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Class III directors (expiring in 2026): Drs. Adams and Venkatesan and Ms. Ashe.
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Rule 5605 of the Nasdaq Listing Rules requires a majority of a
listed company’s board of directors to be comprised of independent directors. In addition, the Nasdaq Listing Rules require that, subject to specified exceptions, each member of a listed company’s audit, compensation and nominating and
corporate governance committees be independent and that audit committee members also satisfy independence criteria set forth in Rule 10A-3 under the Exchange Act. Under Rule 5605(a)(2), a director will only qualify as an “independent director”
if, in the opinion of the Board of Directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In order to be considered independent for
purposes of Rule 10A-3, a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the board of directors, or any other board committee, accept, directly or indirectly, any
consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries or otherwise be an affiliated person of the listed company or any of its subsidiaries.
It is anticipated that each individual expected to serve on the
combined company’s Board of Directors upon the completion of the Merger, other than Mr. Connelly and Dr. Venkatesan, will qualify as an independent director under the Nasdaq listing standards.
The Combined Company Board is expected to have separate positions
of Chairperson and Chief Executive Officer in order to reinforce the independence of the board of directors from management, create an environment that encourages objective oversight of management’s performance and enhance the effectiveness of
the board of directors as a whole. As such, the board of directors of the combined company shall be chaired by Dr. Adams, an independent director, and Mr. Connelly will serve as the combined company’s President and Chief Executive Officer.
One of the key functions of the Combined Company Board will be to
oversee the combined company’s risk management process. The board of directors is not anticipated to have a standing risk management committee, but rather expects to administer this oversight function directly through the board of directors as
a whole, as well as through various standing committees of the board of directors that address risks inherent in their respective areas of oversight. In particular, the board of directors is responsible for monitoring and assessing strategic
risk exposure and the combined company’s Audit Committee will have the responsibility to consider and discuss the major financial risk exposures and the steps its management should take to monitor and control such exposures, including
guidelines and policies to govern the process by which risk assessment and management will be undertaken. The Audit Committee is also expected to monitor compliance with legal and regulatory requirements. The combined company’s Compensation
Committee will also assess and monitor whether the combined company’s compensation plans, policies and programs comply with applicable legal and regulatory requirements.
The Combined Company Board will have an Audit Committee, a
Compensation Committee and a Nominating and Corporate Governance Committee, each of which will have the composition and the responsibilities described below.
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The purpose of the Audit Committee of the Board of Directors is to
oversee the corporate accounting and financial reporting processes and audits of financial statements. For this purpose, the Audit Committee performs several functions, including among other things:
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appoints its independent registered public accounting firm;
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evaluates the independent registered public accounting firm's qualifications, independence and performance;
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determines the engagement of the independent registered public accounting firm;
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reviews and approves the scope of the annual audit and pre-approves the audit and non-audit fees and services;
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reviews and approves all related party transactions on an ongoing basis;
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establishes procedures for the receipt, retention and treatment of complaints received regarding accounting, internal
accounting controls or auditing matters;
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discusses with management and the independent registered public accounting firm the results of the annual audit and the
review of the company’s quarterly financial statements;
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approves the retention of the independent registered public accounting firm to perform any proposed permissible non-audit
services;
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monitors the rotation of partners of the independent registered public accounting firm on the company’s engagement team in
accordance with requirements established by the SEC;
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discusses on a periodic basis, or as appropriate, with management the policies and procedures with respect to risk assessment
and risk management;
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reviews the company’s financial statements and its management's discussion and analysis of financial condition and results of
operations to be included in the company’s annual and quarterly reports to be filed with the SEC;
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annually reviews and assesses internal controls and treasury functions including cash management procedures;
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investigates any reports received through the ethics helpline and report to the Board of Directors periodically with respect
to the information received through the ethics helpline and any related investigations;
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consults with management to establish procedures and internal controls relating to cybersecurity;
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reviews the company’s critical accounting policies and estimates; and
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reviews the audit committee charter and the committee's performance at least annually.
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The Audit Committee of the combined company is expected to retain
these duties and responsibilities following the completion of the Merger.
Following the completion of the Merger, the members of the
combined company’s Audit Committee are expected to be Ms. Wilson, who is expected to be the Chair, Dr. Adams and Mr. Segal. All members of the Audit Committee will meet the requirements for financial literacy under the applicable rules and
regulations of the SEC and Nasdaq and at least one member of the Audit Committee will qualify as an audit committee financial expert as defined under the applicable rules of the SEC and have the requisite financial sophistication as defined
under the applicable rules and regulations of Nasdaq. Under the rules of the SEC, members of the Audit Committee must also meet heightened independence standards. Angion and Elicio believe that, following the completion of the Merger, each
member of the Audit Committee will be independent under the applicable rules of the SEC and Nasdaq. The Audit Committee will operate under a written charter that will satisfy the applicable standards of the SEC and Nasdaq.
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The Compensation Committee oversees policies relating to
compensation and benefits of officers and employees. The Compensation Committee reviews and approves or recommends to the Angion’s Board corporate goals and objectives relevant to compensation of the executive officers (other than the Chief
Executive Officer), evaluates the performance of these officers in light of those goals and objectives and approves the compensation of these officers based on such evaluations. The Compensation Committee also reviews and approves or makes
recommendations to Angion’s Board regarding the issuance of stock options and other awards under the combined company’s stock plans to the executive officers (other than the Chief Executive Officer). The Compensation Committee reviews the
performance of the Chief Executive Officer and makes recommendations to Angion’s Board with respect to his compensation and Angion’s Board retains the authority to make compensation decisions relative to the Chief Executive Officer. The
Compensation Committee will review and evaluate, at least annually, the performance of the Compensation Committee and its members, including compliance by the Compensation Committee with its charter.
The Chief Executive Officer may not participate in, or be present
during, any deliberations or determinations of the Compensation Committee regarding his compensation or individual performance objectives. The charter of the Compensation Committee grants the Compensation Committee full access to all books,
records, facilities and personnel of the company. In addition, under the charter, the Compensation Committee has the authority to obtain, at the expense of the company, advice and assistance from compensation consultants and internal and
external legal, accounting or other advisors and other external resources the Compensation Committee considers necessary or appropriate in the performance of its duties. The Compensation Committee has direct responsibility for the oversight of
the work of any consultants or advisers engaged for the purpose of advising the Compensation Committee. In particular, the Compensation Committee has the sole authority to retain, in its sole discretion, compensation consultants to assist in
its evaluation of executive and director compensation, including the authority to approve the consultant’s reasonable fees and other retention terms. Under the charter, the Compensation Committee may select, or receive advice from, a
compensation consultant, legal counsel or other adviser to the Compensation Committee, other than in-house legal counsel and certain other types of advisers, only after taking into consideration six factors, prescribed by the SEC and Nasdaq,
that bear upon the adviser’s independence; however, there is no requirement that any adviser be independent.
The Compensation Committee of the combined company is expected to
retain these duties and responsibilities following the completion of the Merger.
Following the completion of the Merger, the members of the
Compensation Committee are expected to be Ms. Ashe, who is expected to be the Chair, Mr. Nissenson and Dr. Ruffolo. To qualify as independent to serve on the combined organization’s Compensation Committee, the Nasdaq listing standards require a
director not to accept any consulting, advisory, or other compensatory fee from the combined company, other than for service on the Combined Company Board, and that the Combined Company Board consider whether a director is affiliated with the
combined company and, if so, whether such affiliation would impair the director’s judgment as a member of the combined company’s Compensation Committee. Angion and Elicio believe that, after the completion of the Merger, the composition of the
Compensation Committee will meet the requirements for independence under, and the functioning of such Compensation Committee will comply with any applicable requirements of the rules and regulations of Nasdaq and the SEC.
The Nominating and Corporate Governance Committee of Angion’s
Board is responsible for making recommendations to Angion’s Board regarding candidates for directorships and the size and composition of Angion’s Board. In addition, the Nominating and Corporate Governance Committee is responsible for
overseeing corporate governance policies and reporting and making recommendations to Angion’s Board concerning governance matters.
Following the completion of the Merger, the members of the
Nominating and Corporate Governance Committee are expected to be Dr. Adams, who will serve as Chair, Mses. Ashe, Chudnovsky and Wilson. Each of the members of the combined company’s Nominating and Corporate Governance Committee will be
independent under the applicable rules and regulations of Nasdaq relating to nominating and corporate governance committee independence. Angion’s Board has adopted a written Nominating and Corporate Governance Committee charter available to
stockholders.
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The Nominating and Corporate Governance Committee believes
candidates for director should have certain minimum qualifications, including the ability to read and understand basic financial statements, and have the highest personal integrity and ethics. The Nominating and Corporate Governance Committee
also considers such factors as possessing relevant expertise upon which to be able to offer advice and guidance to management, having sufficient time to devote to the affairs of the company, demonstrated excellence in his or her field, having
the ability to exercise sound business judgment and having the commitment to rigorously represent the long-term interests of the company’s stockholders. However, the Nominating and Corporate Governance Committee retains the right to modify
these qualifications from time to time. Candidates for director nominees are reviewed in the context of the current composition of the Board of Directors, the operating requirements of the company and the long-term interests of stockholders. In
conducting this assessment, the Nominating and Corporate Governance Committee typically considers diversity (including gender, racial and ethnic diversity), age, skills and such other factors as it deems appropriate, given the current needs of
the Board of Directors and the company, to maintain a balance of knowledge, experience and capability. The Nominating and Corporate Governance Committee appreciates the value of thoughtful board refreshment, and regularly identifies and
considers qualities, skills and other director attributes that would enhance the composition of the Board of Directors. The Nominating and Corporate Governance Committee takes into account the results of the Board of Directors’ self-evaluation,
conducted annually on a group and individual basis. In the case of new director candidates, the Nominating and Corporate Governance Committee also determines whether the nominee is independent for Nasdaq purposes, which determination is based
upon applicable Nasdaq listing standards, applicable SEC rules and regulations and the advice of counsel, if necessary. The Nominating and Corporate Governance Committee then uses its network of contacts to compile a list of potential
candidates, but may also engage, if it deems appropriate, a professional search firm. The Nominating and Corporate Governance Committee conducts any appropriate and necessary inquiries into the backgrounds and qualifications of possible
candidates after considering the function and needs of the Board of Directors. The Nominating and Corporate Governance Committee meets to discuss and consider the candidates’ qualifications and then selects a nominee for recommendation to the
Board of Directors by majority vote.
The Nominating and Corporate Governance Committee of the combined
company is expected to retain these responsibilities following completion of the Merger.
In connection with the completion of the Merger, the Combined
Company Board is expected to select members of the Compensation Committee. Each member of the Compensation Committee is expected to be a “non-employee” director within the meaning of Rule 16b-3 of the rules promulgated under the Exchange Act
and independent within the meaning of the independent director guidelines of Nasdaq. None of the proposed combined company’s executive officers serves as a member of the board of directors or compensation committee of any entity that has one or
more executive officers who is proposed to serve on the combined company’s Board of Directors or Compensation Committee following the completion of the Merger.
Following the completion of the Merger, the Combined Company Board
expects to retain the Corporate Governance Guidelines adopted by Angion, which are designed to assure the Board of Directors will have the necessary authority and practices in place to review and evaluate the combined company’s business
operations as needed and to make decisions that are independent of the combined company’s management. The guidelines are also intended to align the interests of directors and management with those of the combined company’s stockholders. The
Corporate Governance Guidelines set forth the practices the Board of Directors intends to follow with respect to board composition and selection including diversity, board meetings and involvement of senior management, and board committees and
compensation. The Corporate Governance Guidelines, as well as the charters for each committee of the Board of Directors, may be viewed at https://ir.angion.com/corporate-governance/governance-overview.
The Combined Company Board will maintain a Code of Business
Conduct and Ethics that applies to all directors, officers and employees. The Code of Business Conduct and Ethics, and any applicable waivers or amendments, will be made available on the combined company’s website.
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The following is a discussion and analysis of compensation
arrangements of Angion’s named executive officers (Named Executive Officers). This discussion contains forward looking statements that are based on Angion’s current plans, considerations, expectations and determinations regarding future
compensation programs. Actual compensation programs that Angion adopts may differ materially from currently planned programs as summarized in this discussion. As an “emerging growth company” as defined in the JOBS Act, Angion is not required to
include a Compensation Discussion and Analysis section and have elected to comply with the scaled disclosure requirements applicable to emerging growth companies.
Angion seeks to ensure the total compensation paid to Angion’s
executive officers is reasonable and competitive. Compensation of Angion’s executives is structured around the achievement of individual performance and near-term corporate targets as well as long-term business objectives.
Angion’s Named Executive Officers for fiscal year 2022 were as
follows:
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Jay R. Venkatesan, M.D., President and Chief Executive Officer and Chairman of the Board(1);
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Itzhak Goldberg, M.D., Director and Chairman Emeritus(2); and
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John Neylan, M.D., Executive Vice President, Chief Medical Officer and Head of Research(3)
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Jennifer J. Rhodes, J.D., Executive Vice President, Chief Business Officer, Chief Compliance Officer, and Corporate Secretary(4)
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(1)
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Dr. Venkatesan was appointed Chairman of the Angion Board in January 2022.
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(2)
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After serving as Executive Chairman and Chief Scientific Officer for Angion during the year ended December 31, 2021, Dr.
Goldberg resigned his employment in February 2022, and no longer serves as an Executive Officer of Angion.
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(3)
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After being appointed Executive Vice President and Head of Research in March 2022, and serving in that role and as Chief
Medical Officer until August 2022, Dr. Neylan departed from Angion in August 2022 as part of a reduction in force.
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(4)
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Ms. Rhodes appointed Chief Business Officer in March 2022, and continues to serve as General Counsel, Chief Compliance Officer
and Secretary.
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Summary Compensation Table
The following table sets forth total compensation paid to Angion’s
Named Executive Officers for the fiscal years ending on December 31, 2022 and 2021, other than Ms. Rhodes, who was not a named executive officer for 2021 and, accordingly, her compensation for 2021 is omitted.
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Name and Principal Position
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Year
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Salary
($)
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Option
awards ($)(1)
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All other
compensation
($)(2)
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Total ($)
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Jay R. Venkatesan, M.D.,
President and Chief Executive Officer and Chairman of the Board
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2022
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608,000
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898,973
|
| |
11,876
|
| |
1,518,849
|
| |
2021
|
| |
587,100
|
| |
1,952,099
|
| |
11,600
|
| |
2,550,799
|
||
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Itzhak D. Goldberg, M.D.,
Executive Chairman and Chief Scientific Officer(3)
|
| |
2022
|
| |
80,670
|
| |
—
|
| |
773,663
|
| |
854,333
|
| |
2021
|
| |
484,018
|
| |
763,863
|
| |
11,600
|
| |
1,259,481
|
||
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
John F. Neylan, M.D.,
Executive Vice President, Chief Medical Officer and Head of Research(4)
|
| |
2022
|
| |
343,613
|
| |
320,613
|
| |
403,716
|
| |
1,067,941
|
| |
2021
|
| |
468,650
|
| |
763,863
|
| |
11,600
|
| |
1,244,113
|
||
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Jennifer Rhodes
Executive Vice President, Chief Business Officer, General Counsel, Chief
Compliance Officer and Secretary(5)
|
| |
2022
|
| |
440,840
|
| |
320,613
|
| |
12,200
|
| |
773,653
|
|
(1)
|
Amounts shown represents the grant date fair value of options granted as calculated in accordance with ASC Topic 718. See Note
2 of the financial statements included in Angion’s consolidated financial statements included in this proxy statement/prospectus/information statement for the assumptions used in calculating this amount.
|
271
|
(2)
|
All other compensation includes severance benefits in the form of cash severance of $363,825 and COBRA payments equal to
$28,842 paid to Dr. Neylan in 2022 pursuant to Angion’s Executive Separation Benefits Plan dated August 15, 2022, and severance benefits in the form of cash payments tied to salary of $484,018 and tied to bonus of $363,014, and COBRA
payments equal to $2,174 paid to Dr. Goldberg pursuant to his severance agreement with Angion dated February 25, 2022. Amounts also include a company match under Angion’s 401(k) plan in the following amounts: Dr. Venkatesan, $11,876 and
$11,600 for 2022 and 2021; Dr. Goldberg, $5,125 and $11,600 for 2022 and 2021; Dr. Neylan, $11,049 and $11,600 for 2022 and 2021; and Ms. Rhodes, $12,200 for 2022.
|
|
(3)
|
After serving as Executive Chairman and Chief Scientific Officer for Angion during the year ended December 31, 2021, Dr.
Goldberg resigned his employment in February 2022, and no longer serves as an Executive Officer of Angion. Dr. Goldberg continues to serve as a Director and Chairman Emeritus.
|
|
(4)
|
After being appointed Executive Vice President and Head of Research in March 2022 and serving in that role and as Chief
Medical Officer until August 2022, Dr. Neylan departed from Angion in August 2022 as part of a reduction in force.
|
|
(5)
|
Ms. Rhodes was appointed Executive Vice President, Chief Business Officer in March 2022, and continues to serve as General
Counsel, Chief Compliance Officer and Secretary.
|
Narrative to Summary Compensation Table
2022 Salaries
Angion’s Named Executive Officers each receive a base salary to
compensate them for services rendered to Angion. The base salary payable to each Named Executive Officer is intended to provide a fixed component of compensation reflecting the executive’s skill set, experience, role and responsibilities. Dr.
Venkatesan’s annual base salary in 2021 was $587,100 and was increased to $608,000, effective as of January 1, 2022. Dr. Goldberg’s annual base salary in 2021 was $484,018 and remained the same through the end of his employment with Angion in
February of 2022. Dr. Neylan’s annual base salary in 2021 was $468,650 and was increased to $485,100 effective as of January 1, 2022 and remained the same through the end of his employment with Angion in August 2022. Angion’s Board and
compensation committee may adjust base salaries from time to time in their discretion.
2022 Bonuses
Angion’s Named Executive Officers did not receive a discretionary
cash bonus in 2021 or 2022 (except for the bonus paid to Dr. Goldberg for as required by Dr. Goldberg’s severance agreement with Angion dated February 25, 2022. The bonus targets for Angion’s Named Executive Officers were 55% of base salary for
Dr. Venkatesan, and 40% of base salary for Dr. Goldberg, Dr. Neylan, and Ms. Rhodes.
Equity-Based Compensation
In March 2022, Angion granted each of Dr. Venkatesan, Dr. Neylan
and Ms. Rhodes an option to purchase 760,000, 275,000, and 275,000 shares of its common stock, respectively, under Angion’s 2021 Incentive Award Plan (Angion’s 2021 Plan). Of Dr. Venkatesan’s grant of options, 600,000 vest as to 1/48th of the
shares subject to the option on each monthly anniversary of March 3, 2022, and 160,000 vest in two tranches of 50% on July 31, 2022, and December 31, 2022. Of Dr. Neylan’s and Ms. Rhodes’ grants of options, 175,000 vest as to 1/48th
of the shares subject to the option on each monthly anniversary of March 2, 2022, and 100,000 vest in two tranches of 50% on July 31, 2022, and December 31, 2022. All vesting by the Named Executive Officer is subject to being employed or in
continuous service to Angion as defined in the 2021 Plan through such vesting date. Dr. Neylan is no longer employed by Angion as of August 2022, and he had no outstanding options as of December 31, 2022, issued under the 2021 Plan or the
Amended and Second Restated 2015 Equity Award Plan (Angion’s 2015 Plan).
In February 2021, Angion granted each of Dr. Venkatesan, Dr.
Goldberg and Dr. Neylan an option to purchase 178,920, 70,012 and 70,012 shares of its common stock, respectively, under the Angion 2021 Plan. Each of Dr. Venkatesan's, Dr. Goldberg’s and Dr. Neylan’s options vest as to 1/48th of the shares
subject to the option on each monthly anniversary of February 5, 2021, subject to the applicable Named Executive Officer being employed or in continuous service to Angion as defined in the Angion 2021 Plan through such vesting date. Upon
Angion’s IPO in February 2021, Dr. Venkatesan’s and Dr. Goldberg’s performance-based restricted stock units (PSUs) met the performance condition, an initial public offering as defined in the Angion 2015 Plan. Accordingly, the vesting of such
PSUs was in three equal parts, with the first part vesting commenced upon the IPO in February 2021, the second part vesting for each Dr. Venkatesan and Dr. Goldberg on June 24, 2021, and the third part vested for each on June 24, 2022. As of
December 31, 2022, 556,530 shares subject to the PSUs have been vested.
Other Elements of Compensation
Severance Plans
For a description of Angion’s severance plans and arrangements,
see “Potential Payments Upon Termination or Change of Control” below.
272
Retirement Savings and Health and Welfare
Benefits
On January 1, 2021, Angion implemented a 401(k) Retirement Savings
Program through a third-party provider. Angion’s Named Executive Officers are eligible to participate Angion’s 401(k) Program on the same terms as other full-time employees. Angion matches 100% of the first 3% of a participant’s annual eligible
contributions to their 401(k) plan, and 50% of annual eligible contribution between 3% and 5%. Angion believes that providing a vehicle for tax-deferred retirement savings though 401(k) Plan and Angion’s former simple IRA plan adds to the
overall desirability of Angion’s executive compensation package and further incentivizes Angion’s employees, including Angion’s Named Executive Officers, in accordance with Angion’s compensation policies.
All of Angion’s full-time employees, including Angion’s Named
Executive Officers, are eligible to participate in Angion’s health and welfare plans, including medical, dental and vision benefits; short-term and long-term disability insurance; and life and AD&D insurance.
Perquisites and Other Personal Benefits
Angion determines perquisites on a case-by-case basis and will
provide a perquisite to a Named Executive Officer when it believes it is necessary to attract or retain the Named Executive Officer. In 2022 and 2021, Angion did not provide any perquisites or personal benefits to Angion’s Named Executive
Officers not otherwise made available to Angion’s other employees.
Outstanding Equity Awards at 2022 Fiscal Year End
The following table lists all outstanding equity awards held by
Angion’s Named Executive Officers as of December 31, 2022.
|
Name
|
| |
Vesting
Commencement
Date(1)
|
| |
Option Awards
|
| |
Stock Awards
|
||||||||||||
| |
Number
of
Securities
Underlying
Unexercised
Options
Exercisable
(#)
|
| |
Number
of
Securities
Underlying
Unexercised
Options
Unexercisable
(#)
|
| |
Option
Exercise
Price
($)
|
| |
Option
Expiration
Date
|
| |
Number
of
Shares
that
Have
Not
Vested
(#)
|
| |
Market
Value of
Shares or
Units of
Shares
that Have
Not Vested
($)(2)
|
|||||
|
Jay R. Venkatesan, M.D.
|
| |
5/1/2018(3)
|
| |
934,400
|
| |
—
|
| |
5.89
|
| |
5/1/2028
|
| |
—
|
| |
—
|
| |
6/18/2020
|
| |
77,791
|
| |
46,675
|
| |
7.77
|
| |
6/17/2030
|
| | | | ||||
| |
2/5/2021
|
| |
82,005
|
| |
96,915
|
| |
16.00
|
| |
2/4/2031
|
| |
—
|
| |
—
|
||
| |
3/3/2022(6)
|
| |
272,500
|
| |
487,500
|
| |
1.94
|
| |
3/2/2032
|
| |
—
|
| |
—
|
||
|
Itzhak Goldberg, M.D.
|
| |
12/19/2018(4)
|
| |
40,600
|
| |
—
|
| |
6.05
|
| |
1/21/2029
|
| |
—
|
| |
—
|
| |
6/18/2020
|
| |
38,895
|
| |
23,338
|
| |
7.77
|
| |
6/17/2030
|
| |
—
|
| |
—
|
||
| |
2/5/2021
|
| |
32,088
|
| |
37,924
|
| |
16.00
|
| |
2/4/2031
|
| |
—
|
| |
—
|
||
|
Jennifer J. Rhodes
|
| |
2/14/2020(4)
|
| |
113,040
|
| |
3,647
|
| |
9.51
|
| |
2/13/2030
|
| |
—
|
| |
—
|
| |
2/14/2020(5)
|
| |
—
|
| |
—
|
| |
—
|
| |
2/13/2030
|
| |
15,802
|
| |
12,831
|
||
| |
6/18/2020
|
| |
36,464
|
| |
21,879
|
| |
7.77
|
| |
6/17/2030
|
| | | | ||||
| |
2/5/2021
|
| |
32,088
|
| |
37,924
|
| |
16.00
|
| |
2/4/2031
|
| |
—
|
| |
—
|
||
| |
3/2/2022(6)
|
| |
132,812
|
| |
142,188
|
| |
1.99
|
| |
3/1/2032
|
| |
—
|
| |
—
|
||
|
John Neylan, M.D.(7)
|
| | | | | | | | | | | | | |
—
|
||||||
|
(1)
|
Except as otherwise noted, all grants with a vesting commencement date in June 2020 and thereafter vest as to 1/48th of the
shares subject to the award on each monthly anniversary of the vesting commencement date, subject to the Named Executive Officer’s continued service to Angion through each vesting date.
|
|
(2)
|
The market value of shares that have not vested is calculated based on a value of $0.812 per share, the closing price of
Angion’s common stock as of December 30, 2022, the last trading day of 2022.
|
|
(3)
|
The stock option award vests as to 25% of the shares on the vesting commencement date and thereafter 10% of the shares vest on
each quarterly anniversary, subject to Dr. Venkatesan’s continued service to Angion through such vesting date; provided that an additional 25% of the shares can vest if certain financing goals are achieved. This award is fully vested.
|
|
(4)
|
The stock option award vests as to 25% of the shares on the first anniversary of the vesting commencement date and vest as to
the remaining 75% of the shares in 24 substantially equal monthly installments thereafter, such that all awards will be vested on the anniversary of the vesting commencement date, subject to the Named Executive Officer’s continued
service to Angion through such vesting date.
|
273
|
(5)
|
The restricted stock units shall vest as to 25% of the shares on the first anniversary of the vesting commencement date and
vest as to the remaining 75% of the shares in 24 substantially equal monthly installments thereafter, such that all awards will be vested on the third anniversary of the vesting commencement date. In January 2022, the vesting schedule
for this grant was modified to vest annually on January 13, 2023, and then the vesting schedule was subsequently modified in December 2022 so that vesting shall occur upon certain triggering events in an amount equal to what she would
have other vested on the original monthly schedule, including if Ms. Rhodes is involuntary terminated, Ms. Rhodes resigned her employment with Angion, or if the current merger transaction announced by Angion on January 17, 2023 is
abandoned.
|
|
(6)
|
Dr. Venkatesan and Ms. Rhodes each received two stock option awards in March of 2022. The first award granted Dr. Venkatesan
of 600,000 share and Ms. Rhodes of 160,000 shares, all vest at a rate of 1/48th of the shares subject to the award each month following the vesting commencement date. The second award granted Dr. Venkatesan of 160,000 shares
and Ms. Rhodes of 100,000 shares, all vest at a rate of 50% on July 31, 2022 and December 31, 2022. Both awards are subject to subject to the Named Executive Officer’s continued service to Angion through each vesting date.
|
|
(7)
|
Dr. Neylan has no outstanding equity awards as of December 31, 2022, due to the end of his employment on August 15, 2022 and
consistent with the term of the 2021 and 2015 Plans.
|
Executive Compensation Arrangements
Service Agreements
Jay R. Venkatesan, M.D.
In March 2019, Angion entered into an amended and restated
employment agreement with Dr. Venkatesan, which set forth his base salary going forward, an additional stock grant of 45,419 shares of Angion’s common stock as compensation for service previously rendered and eligibility to participate in
Angion’s benefit plans. Dr. Venkatesan was also eligible to receive an additional equity award that was granted by Angion in June 2019.
Jennifer J. Rhodes, J.D.
In November 2019, Angion entered into an offer letter agreement
with Ms. Rhodes (as amended in February 2020), which sets forth the terms and conditions of her employment as Angion’s Senior Vice President, General Counsel effective as of January 2020. In addition to her base salary and an annual target
bonus, Ms. Rhodes is also eligible to receive an option grant and a restricted stock unit grant, each of which was granted by Angion in February 2020. The offer letter also provides for a sign-on bonus of $100,000 payable with respect to 50% of
such amount in March 2020 and the remaining 50% in September 2020. Ms. Rhodes is entitled to participate in all applicable health and welfare benefit programs for which other executive employees of Angion are generally eligible. Pursuant to the
terms of such agreement and the accompanying confidential information, non-disclosure and assignment of inventions agreement, Ms. Rhodes is subject to indefinite confidentiality restrictions, standard intellectual property provisions and
non-solicitation restrictions effective during and 12 months post-employment.
Gregory Curhan
In June 2020, Angion entered into a consulting agreement (which
was subsequently amended for the last time in March 2022) setting forth the terms and conditions for Mr. Curhan’s service to Angion as its Chief Financial Officer. Pursuant to the consulting agreement, Mr. Curhan provides part-time consulting
services to Angion as Angion’s Chief Financial Officer. Mr. Curhan receives $550 per hour for his services.
Potential Payments Upon Termination or Change of Control
In connection with Angion’s initial public offering, Angion
entered into new severance and change in control plan covering all of Angion’s Named Executive Officers superseding and replacing the severance benefits they would otherwise be entitled to receive, other than Dr. Goldberg, as further described
below.
Under Angion’s severance plan encompassing each of Angion’s Named
Executive Officers, if such Named Executive Officer’s employment with Angion is terminated without “cause” or such Named Executive Officer resigns for “good reason” (as each is defined in the severance plan), the applicable Named Executive
Officer will be entitled to receive: (i) nine months of continued base salary (or 12 months for Dr. Venkatesan) and (ii) payment or reimbursement of the cost of continued healthcare coverage for nine months (or 12 months for Dr. Venkatesan). In
lieu of the foregoing benefits, if each Named Executive Officer’s employment with Angion is terminated without “cause” or such Named Executive Officer resigns for “good reason” during the 12-month period following a Change in Control (as
defined in the 2021 Plan), the applicable Named Executive Officer will be entitled to receive: (i) 12 months of continued base salary (or 18 months for Dr. Venkatesan), (ii) payment or reimbursement of the cost of continued healthcare coverage
for 12 months (or 18 months for Dr. Venkatesan), (iii) an amount equal to 12 months
274
of such Named Executive Officer’s annual bonus for the year of termination
assuming 100% of target performance (or 18 months for Dr. Venkatesan) and (iv) full accelerated vesting of any of unvested equity awards (except for any performance awards). The foregoing severance benefits are subject to the applicable Named
Executive Officer’s delivery of an executed release of claims against Angion and continued compliance with the Named Executive Officer’s confidentiality obligations under the severance plan.
Until February 28, 2022, Dr. Goldberg had separate severance
arrangements with Angion set forth in his Employment Agreement with Angion dated May 1, 2018, providing him severance pay, annual bonus payments and COBRA reimbursements for eighteen (18) months for any termination without “cause”, resignation
for “good reason”, or “change of control” as defined by his Employment Agreement. On February 25, 2022, Angion and Dr. Goldberg entered into a Separation Agreement on such terms.
On January 13, 2023, the Angion Board adopted the Angion Biomedica
Corp. Retention Bonus Plan (Retention Bonus Plan). Participants in the Retention Bonus Plan include Dr. Venkatesan and Ms. Rhodes. The Retention Bonus Plan provides for the payment of a cash retention bonus equal to 100% of a participant’s base
salary, 65% of which becomes earned and payable upon the occurrence of a corporate triggering event (defined to include a change in control (as defined in Angion’s 2021 Plan), a reverse merger or a dissolution) and 35% of which becomes earned
and payable three months after the occurrence of such corporate triggering event, subject in each case to earlier payment upon the occurrence of a qualifying termination of the participant’s employment by Angion without “cause” or by the
participant for “good reason,” each as defined in the Retention Bonus Plan. Upon the earlier of a corporate triggering event or a qualifying termination, time-based equity awards will vest in full, the post-termination exercise period of
options held by the participant will be extended by four years (but no later than the original term of the option) and participants will receive an additional lump sum cash payment (approximately $1,464,000 in the case of Dr. Venkatesan and
$642,000 in the case of Ms. Rhodes, in each case less applicable withholding). Participants will no longer have the right to receive any payments under Angion’s Executive Separation Benefits Plan. The receipt of payments under the Retention
Bonus Plan is subject to the execution of a general release of claims by the participant. Concurrently, the Angion Board approved modifications of the Angion stock options held by Mr. Curhan, such that, upon the earlier of a corporate
triggering event or a qualifying termination and subject to Mr. Curhan’s execution of a general release of claims, one option granted in 2022 will vest in full and the post-termination exercise period of all options will be extended by four
years (but no later than the original term of the option).
Angion approved a compensation policy for Angion’s non-employee
directors (Director Compensation Program) that became effective in connection with the consummation of Angion’s initial public offering in February 2021 and is subject to amendment by the Angion Board as appropriate. Pursuant to the Director
Compensation Program, Angion’s non-employee directors receive cash compensation as follows:
|
•
|
Each non-employee director will receive an annual cash retainer in the amount of $40,000 per year.
|
|
•
|
The Non-Executive Chairperson will receive an additional annual cash retainer in the amount of $35,000 per year.
|
|
•
|
The lead non-employee director will receive an additional annual cash retained in the amount of $20,000 per year.
|
|
•
|
The chairperson of the audit committee will receive additional annual cash compensation in the amount of $15,000 per year for
such chairperson’s service on the audit committee. Each non-chairperson member of the audit committee will receive additional annual cash compensation in the amount of $7,500 per year for such member’s service on the audit committee.
|
|
•
|
The chairperson of the compensation committee will receive additional annual cash compensation in the amount of $10,000 per
year for such chairperson’s service on the compensation committee. Each non-chairperson member of the compensation committee will receive additional annual cash compensation in the amount of $5,000 per year for such member’s service on
the compensation committee.
|
|
•
|
The chairperson of the nominating and corporate governance committee will receive additional annual cash compensation in the
amount of $8,000 per year for such chairperson’s service on the nominating and corporate governance committee. Each non-chairperson member of the nominating and corporate governance committee will receive additional annual cash
compensation in the amount of $5,000 per year for such member’s service on the nominating and corporate governance committee.
|
275
Under the Director Compensation Program, as amended by the
Board of Directors on March 8, 2021 and on June 9, 2022, each eligible non-employee director will automatically be granted an option to purchase 30,000 shares of Angion’s common stock upon the director’s initial appointment or election to
Angion’s Board (Initial Grant) and an option to purchase 15,000 shares of Angion’s common stock automatically on the date of each annual stockholder’s meeting thereafter, (Annual Grant), unless otherwise approved by the Board of Directors. The
Director Compensation Program also provides for accelerated vesting of unvested director awards upon a change of control.
The Initial Grant will vest as to 1/36th of the underlying shares
on a monthly basis over three years, subject to continued service through each applicable vesting date. The Annual Grant will vest on the earlier of the first anniversary of the date of grant or the date of the next annual stockholder’s meeting
to the extent unvested as of such date, subject to continued service through each applicable vesting date. The exercise price per share of director options is equal to the fair market value of a share of Angion’s common stock on the grant date,
and the director options will vest in full upon (i) a termination of service due to the director’s death or Disability (as defined in Angion’s 2021 Plan) and (ii) the consummation of a Change in Control (as defined in Angion’s 2021 Plan).
The following table sets forth information concerning the
compensation earned by Angion’s non-employee directors during the year ended December 31, 2022.
|
Name
|
| |
Fees Earned
or Paid
in Cash ($)
|
| |
Option
Awards(1)
($)
|
| |
Total(2)
($)
|
|
Victor Ganzi, J.D.
|
| |
77,500
|
| |
16,275
|
| |
93,775
|
|
Allen Nissenson, M.D.
|
| |
62,500
|
| |
16,275
|
| |
78,775
|
|
Gilbert Omenn, M.D.
|
| |
60,500
|
| |
16,275
|
| |
76,775
|
|
Karen Wilson
|
| |
65,000
|
| |
16,275
|
| |
81,275
|
|
(1)
|
Amounts shown represents the grant date fair value of options granted during fiscal year 2022 as calculated in accordance with
ASC Topic 718. See Note 2 to Angion's consolidated financial statements included in this proxy statement/prospectus/information for the assumptions used in calculating this amount. As of December 31, 2022, Messrs. Ganzi, Nissenson and
Omenn and Ms. Wilson each held options to purchase an aggregate of 68,895 shares of Angion’s common stock.
|
|
(2)
|
Non-employee directors only received cash fees and stock awards as compensation for their service on the Board of Directors.
|
The Compensation Committee of the Angion Board has reviewed and
assessed Angion’s compensation policies and practices as they related to risk management are not reasonably likely to have a material adverse effect on Angion.
276
This section discusses the material components of the executive
compensation program for Elicio’s executive officers who are named in the 2022 Summary Compensation Table below. In 2022, Elicio’s “named executive officers” and their positions were:
|
•
|
Robert Connelly, Chief Executive Officer;
|
|
•
|
Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer; and
|
|
•
|
Annette Matthies, Ph.D, Chief Business Officer.
|
Summary Compensation Table
The following table sets forth information concerning the
compensation of Elicio’s named executive officers for the years indicated.
|
Name and Principal Position
|
| |
Year
|
| |
Salary
|
| |
Stock
Awards(1)
|
| |
Option
Awards(1)
|
| |
Non-equity
Incentive Plan
Compensation
|
| |
Total
|
|
Robert Connelly,
Chief Executive Officer
|
| |
2022
|
| |
$475,000
|
| |
—
|
| |
$572,040
|
| |
$209,000
|
| |
$1,256,040
|
| |
2021
|
| |
$475,000
|
| |
—
|
| |
—
|
| |
$120,156
|
| |
$595,156
|
||
|
Christopher Haqq,
Executive Vice President, Head of Research
and Development and Chief Medical Officer
|
| |
2022
|
| |
$465,025
|
| | | |
$511,321
|
| |
$186,010
|
| |
$1,162,356
|
|
| |
2021
|
| |
$445,000
|
| |
$193,003
|
| |
$—
|
| |
$157,975
|
| |
$795,978
|
||
|
Annette Matthies,
Chief Business Officer
|
| |
2022
|
| |
$353,600
|
| |
—
|
| |
$236,793
|
| |
$106,080
|
| |
$696,473
|
| |
2021
|
| |
$340,000
|
| |
—
|
| |
$325,718
|
| |
$117,300
|
| |
$783,018
|
|
(1)
|
Amounts represent the aggregate grant date fair value of stock options and RSUs issued during the years indicated, computed in
accordance with ASC Topic 718, rather than the amounts paid to or realized by the named individual. We provide information regarding the assumptions used to calculate the value of these awards in Note 12 to the consolidated financial
statements for the years ended December 31, 2021 and 2020 included in this proxy statement/prospectus/information statement.
|
Narrative Disclosure to Summary Compensation Table
2022 Salaries and Bonuses
Each of Mr. Connelly, Dr. Haqq and Dr. Matthies receives a base
salary to provide a fixed component of compensation reflecting the executive’s skill set, experience, role and responsibilities. Annual base salaries are reviewed periodically by the compensation committee of Elicio’s Board. The base salary and
target annual performance bonus for each of Mr. Connelly, Dr. Haqq and Dr. Matthies for year ended December 31, 2022 is listed in the table below:
|
Name
|
| |
2022
Base Salary
|
| |
2022 Target
Performance
Bonus
|
|
Robert Connelly
|
| |
$475,000
|
| |
40%
|
|
Christopher Haqq
|
| |
$465,025
|
| |
40%
|
|
Annette Matthies
|
| |
$353,600
|
| |
40%
|
2022 Equity Compensation
Elicio grants stock options to its employees and certain service
providers, including its named executive officers, as the long-term incentive component of Elicio’s compensation program. Elicio’s stock options generally allow employees to purchase shares of Elicio common stock at a price per share equal to
the fair market value of Elicio common stock on the date of grant, as determined by Elicio’s Board.
277
In November 2022, Elicio granted an option to purchase
8,171,995 shares of Elicio common stock to Mr. Connelly at an exercise price of $0.07 per share, which Elicio’s Board determined to be the fair market value of Elicio common stock on the date of grant. The option is subject to time-based
vesting over 36 months following the grant date but may be early exercised at any time at the election of Mr. Connelly for restricted shares of Elicio common stock until the vesting of the award.
In March 2022, Elicio granted an option to purchase 500,000 shares
of Elicio common stock to Dr. Haqq an exercise price of $0.25 per share, which Elicio’s Board determined to be the fair market value of Elicio common stock on the date of grant. The option is subject to time-based vesting over four years with
25% vesting on the first anniversary of the grant date and monthly thereafter, but may be early exercised at any time at the election of Dr. Haqq for restricted shares of Elicio common stock until the vesting of the award. Further, in November
2022, Elicio granted an option to purchase 5,518,873 shares of Elicio common stock to Dr. Haqq at an exercise price of $0.07 per share, which Elicio’s Board determined to be the fair market value of Elicio common stock on the date of grant. The
option is subject to time-based vesting over 36 months following the grant date but may be early exercised at any time at the election of Dr. Haqq for restricted shares of common stock until the vesting of the award.
In March 2022, Elicio granted an option to purchase 100,000 shares
of Elicio common stock to Dr. Matthies an exercise price of $0.25 per share, which Elicio’s Board determined to be the fair market value of Elicio common stock on the date of grant. The option is subject to time-based vesting over four years
with 25% vesting on the first anniversary of the grant date and monthly thereafter, but may be early exercised at any time at the election of Dr. Matthies for restricted shares of Elicio common stock until the vesting of the award. Further, in
November 2022, Elicio granted an option to purchase 3,025,613 shares of Elicio common stock to Dr. Matthies at an exercise price of $0.07 per share, which Elicio’s Board determined to be the fair market value of Elicio common stock on the date
of grant. The option is subject to time-based vesting over 36 months following the grant date but may be early exercised at any time at the election of Dr. Matthies for restricted shares of common stock until the vesting of the award.
The foregoing March 2022 equity grants were granted under Elicio’s
2012 Equity Incentive Plan, as amended (Elicio 2012 Plan) and the foregoing November 2022 equity grants were granted under Elicio's 2022 Equity Incentive (Elicio’s 2022 Plan).
Other Elements of Compensation
During their employment, Elicio’s named executive officers are
eligible to participate in employee benefit plans and programs, including medical and dental benefits, to the same extent and on the same terms as Elicio’s other full-time employees generally.
Outstanding Equity Awards at 2022 Fiscal Year-End
The following table summarizes the outstanding equity incentive
plan awards for each named executive officer as of December 31, 2022.
|
|
| |
Option Awards
|
| |
Stock Awards
|
|||||||||||||||
|
Name
|
| |
Grant Date
|
| |
Number of
securities
underlying
unexercised
options (#)
exercisable
|
| |
Number of
securities
underlying
unexercised
options (#)
unexercisable
|
| |
Option
exercise
price
($)
|
| |
Option
expiration
date
|
| |
Number of
shares or
units of
stock that
have not
vested
(#)
|
| |
Market value of
shares of units
of stock that
have not
vested
($)
|
|
Robert Connelly
|
| |
9/8/2020(1)
|
| |
1,500,000
|
| |
|
| |
0.17
|
| |
9/8/2030
|
| |
—
|
| |
—
|
| |
11/28/2022(2)
|
| |
8,171,995
|
| | | |
0.07
|
| |
11/28/2032
|
| |
—
|
| |
—
|
|||
|
Christopher Haqq
|
| |
10/9/2019(3)
|
| |
—
|
| | | |
—
|
| | | |
1,426,423
|
| |
99,850
|
||
| |
3/11/2021(3)
|
| |
—
|
| |
|
| |
—
|
| |
|
| |
839,142
|
| |
58,740
|
||
| |
3/31/2022(4)
|
| |
200,000
|
| |
—
|
| |
0.25
|
| |
3/31/2032
|
| |
—
|
| |
—
|
||
| |
11/28/2022(2)
|
| |
5,518,873
|
| |
—
|
| |
0.07
|
| |
11/28/2032
|
| |
—
|
| |
—
|
||
|
Annette Matthies
|
| |
2/1/2021(5)
|
| |
678,580
|
| |
737,586
|
| |
0.23
|
| |
2/1/2031
|
| |
—
|
| |
—
|
| |
3/31/2022(4)
|
| |
100,000
|
| |
—
|
| |
0.25
|
| |
3/31/2032
|
| |
—
|
| |
—
|
||
| |
11/28/2022(2)
|
| |
3,025,613
|
| |
—
|
| |
0.07
|
| |
11/28/2032
|
| |
—
|
| |
—
|
||
|
(1)
|
This option fully vested upon the submission of the IND for ELI-002 on January 21, 2021.
|
278
|
(2)
|
Grant is subject to vesting but may be early exercised by the holder for restricted shares of common stock until the vesting
of the award, which is monthly in equal installments for thirty-six months commencing on the date of grant, assuming Mr. Connelly’s continued service to Elicio through the applicable vesting date.
|
|
(3)
|
Represents a grant of (i) 1,426,423 RSUs subject to both a time-based and a performance-based vesting component assuming Dr.
Haqq’s continued service to Elicio through the applicable vesting date (except as otherwise provided in the grant agreement), with time-based vesting commencing on October 15, 2019 such that one quarter of the original award amount of
1,426,423 RSUs vested on October 15, 2020 and the remainder vesting in a series of 12 equal quarterly installments thereafter; and (ii) 839,142 RSUs, subject to both a time-based and a performance-based vesting component assuming Dr.
Haqq’s continued service to Elicio through the applicable vesting date (except as otherwise provided in the grant agreements), with time-based vesting commencing on October 15, 2019 such that one quarter of the original award amount of
839,142 RSUs vested on October 15, 2020 and the remainder vesting in a series of 12 equal quarterly installments thereafter. All of the foregoing time-based vesting is accelerated in full upon a change in control and the
performance-based vesting achieved upon a change of control. The Merger constitutes such a change of control under the grant agreements and all of the foregoing 2,265,565 RSUs will vest in full and be settled in Elicio common stock
immediately prior to the consummation of the Merger.
|
|
(4)
|
Grant is subject to vesting but may be early exercised by the holder for restricted shares of common stock until the vesting
of the award, which is over four years with 25% vesting on the first anniversary of the date of grant and monthly thereafter assuming the holder’s continued service to Elicio through the applicable vesting date.
|
|
(5)
|
Grant is subject to vesting but may be early exercised by the holder for restricted shares of common stock until the vesting
of the award, which is monthly in equal installments for 36 months commencing on January 3, 2021 assuming Dr. Matthies’ continued service to Elicio through the applicable vesting date.
|
Executive Compensation Arrangements
Below are descriptions of Elicio’s employment arrangements with
Elicio’s named executive officers, each of whom is employed “at will.”
Employment Agreement with Mr. Connelly
We entered into an employment agreement with Mr. Connelly on
November 15, 2018, which governs the terms of his employment as Elicio’s Chief Executive Officer. Pursuant to the terms of the agreement, Mr. Connelly is entitled to an initial annual base salary of $450,000, is eligible to receive an annual
performance bonus with a target achievement of 40% of his base salary, as determined by Elicio’s Board, and an initial stock option grant, which was granted on November 15, 2018 covering 2,154,276 shares of Elicio common stock. Mr. Connelly
exercised this option in September 2020. Mr. Connelly was granted an additional stock option grant on September 8, 2020 covering 1,500,000 shares of Elicio common stock and an additional stock option grant on November 28, 2022 covering
8,171,995 shares of Elicio common stock. Mr. Connelly’s base salary is reviewed annually by the board of directors and the board of directors may, but is not required to, commencing in January 2020, increase his base salary at its discretion.
For the year ended December 31, 2022, Mr. Connelly’s annual base salary was $475,000. If Mr. Connelly is terminated by Elicio without cause or resigns for good reason (each as defined in his employment agreement), in addition to any earned base
salary and unused vacation benefits, Mr. Connelly is entitled to receive continued base salary for six months following his termination of employment in exchange for his execution of a release of claims and a 12 -month non-competition
agreement.
Employment Agreement with Dr. Haqq
We entered into an offer letter of employment with Dr. Haqq on
September 29, 2019, which governs the current terms of Dr. Haqq’s employment as Elicio’s Executive Vice President, Head of R&D and Chief Medical Officer. Pursuant to the terms of his offer letter, Dr. Haqq is entitled to an annual base
salary of $430,000, which is subject to modification from time to time at the discretion of the board of directors, is eligible to receive an annual performance bonus with a target achievement of 40% of his base salary, as determined by
Elicio’s Board, and an initial grant of RSUs, which was granted on October 9, 2019 covering 1,426,423 shares of Elicio common stock and an additional grant of RSUs, which was granted on March 11, 2021 covering 839,142 shares of Elicio common
stock. Dr. Haqq was also granted a stock option grant on March 31, 2022 covering 500,000 shares of Elicio common stock and an additional stock option on November 28, 2022 covering 5,518,873 shares of Elicio common stock. For the year ended
December 31, 2022, Dr. Haqq’s annual base salary was $465,025. Under the terms of his offer letter, Dr. Haqq is also entitled to an annual allowance to be used for the rental or purchase of an apartment near Elicio’s headquarters previously in
Cambridge, Massachusetts and now in Boston, Massachusetts, with such annual allowance subject to applicable taxes. We have agreed to establish an office in the San Francisco, California area to facilitate meetings and teleconferencing for Dr.
Haqq. If Dr. Haqq is terminated by Elicio without cause or resigns for good reason (each as defined in his offer letter), Dr. Haqq is entitled to receive, subject to his execution of a release of claims, (i) continued base salary for six months
following his termination of employment, (ii) to the extent Dr. Haqq is terminated after June 30 in a particular calendar year, a pro-rated target bonus (iii) accelerated vesting
279
of the time-based vesting portion of Dr. Haqq’s RSU award that would have vested
in the 12 months following his termination of employment, and (iv) to the extent Dr. Haqq timely elects COBRA coverage, an amount equal to the employer-paid premiums we would otherwise pay for similarly situated active employees for six months.
Under the terms of his offer letter, Dr. Haqq’s RSU award will accelerate in full upon a change of control as defined in the 2012 Plan. The Merger constitutes such a change of control under the 2012 Plan and his RSU award will vest in full and
be settled in Elicio common stock immediately prior to the consummation of the Merger.
Employment Agreement with Dr. Matthies
We entered into an offer letter with Dr. Matthies on January 12,
2021, which governs the current terms of Dr. Matthies’ employment as Elicio’s Chief Business Officer. Pursuant to the terms of her offer letter, Dr. Matthies is entitled to an annual base salary of $340,000, which is subject to modification
from time to time at the discretion of the board of directors, is eligible to receive an annual performance bonus with a target achievement of 40% of her base salary, as determined by Elicio’s Board, and an initial stock option grant, which was
granted on February 1, 2021 covering 1,416,166 shares of Elicio’s common stock, an additional stock option grant, which was granted on March 31, 2022 covering 100,000 shares of Elicio’s common stock, and an additional stock option grant, which
was granted on November 28, 2022 covering 3,025,613 shares of Elicio’s common stock. For the year ended December 31, 2022, Dr. Matthies’ annual base salary was $353,600. If Dr. Matthies is terminated by Elicio without cause or resigns for good
reason (each as defined in her offer letter), in addition to any earned base salary and unused vacation benefits, Dr. Matthies is entitled to receive continued base salary for six months following her termination of employment in exchange for
her execution of a release of claims.
Compensation Changes in Connection with Merger
In connection with the Merger, we may enter into new or additional
compensation arrangements with Elicio’s named executive officers. The terms of any such arrangements are not yet known.
During Elicio’s year ended December 31, 2022, certain of the
non-employee directors who served on Elicio’s Board received cash fees and options to purchase shares of Elicio’s common stock. Mr. Connelly did not receive any compensation from Elicio during Elicio’s fiscal year ended December 31, 2022 for
his service as a director and is not included in the table below.
2022 Director Compensation Table
|
Name
|
| |
Fees earned
or paid in
cash
($)(1)
|
| |
Option
awards
($)(2)(3)
|
| |
Total
($)
|
|
Julian Adams(4)(5)
|
| |
50,000
|
| |
150,964
|
| |
200,964
|
|
Carol Ashe(4)(5)
|
| |
35,000
|
| |
57,165
|
| |
92,165
|
|
Yekaterina (Katie) Chudnovsky(5)
|
| |
—
|
| |
17,500
|
| |
17,500
|
|
Daniel Geffken(4)(5)
|
| |
35,000
|
| |
83,609
|
| |
118,609
|
|
Ofer Gonen(6)
|
| |
—
|
| |
—
|
| |
—
|
|
Daphne Karydas(4)(5)
|
| |
35,000
|
| |
57,165
|
| |
92,165
|
|
Assaf Segal(5)
|
| |
—
|
| |
17,500
|
| |
17,500
|
|
Robert Ruffolo, Jr.(4)(5)
|
| |
35,000
|
| |
62,752
|
| |
97,752
|
|
(1)
|
The amounts reported in this column reflect annual or prorated amounts for the portion of the year such individual served as a
member of Elicio’s Board.
|
|
(2)
|
The amounts represent the aggregate grant date fair value of stock and option awards granted by Elicio in 2022, computed in
accordance with FASB ASC Topic 718. For further information on how we account for stock-based compensation, see Note 13 to Elicio’s consolidated financial statements. These amounts reflect Elicio’s accounting expense for these awards
and do not correspond to the actual amounts, if any, that will be recognized by the directors. None of Elicio’s non-employee directors have been granted stock awards or any other equity compensation other than stock options.
|
280
|
(3)
|
The table below shows the aggregate number of outstanding option awards held as of December 31, 2022 by each non-employee
director who was serving as of December 31, 2022. The number of options outstanding reflects stock option awards that may be early exercised at any time at the election of the holder for restricted shares of Elicio common stock until
the full vesting of the award.
|
|
Name
|
| |
Number of
Options outstanding
|
|
Julian Adams
|
| |
2,799,839
|
|
Carol Ashe
|
| |
752,946
|
|
Yekaterina (Katie) Chudnovsky
|
| |
250,000
|
|
Daniel Geffken
|
| |
1,355,442
|
|
Ofer Gonen
|
| |
—
|
|
Daphne Karydas
|
| |
752,946
|
|
Assaf Segal
|
| |
250,000
|
|
Robert Ruffolo, Jr.
|
| |
872,769
|
|
(4)
|
Grant made on March 31, 2022 and subject to vesting based on continued service, but may be early exercised by the holder for
restricted shares of common stock until the vesting of the award, which is over three years with 25% vesting on the first anniversary of the date of grant and monthly thereafter.
|
|
(5)
|
Grant made on December 6, 2022 and subject to vesting based on continued service but may be early exercised by the holder for
restricted shares of common stock until the vesting of the award, which is over four years with 25% vesting on the first anniversary of the date of grant and monthly thereafter.
|
|
(6)
|
Mr. Gonen ceased his service on Elicio’s Board in June 2022.
|
Non-employee Director Compensation
During 2022, Elicio compensated certain of Elicio’s non-employee
directors for their service as directors. Accordingly, Mr. Connelly, Elicio’s Chief Executive Officer and a member of Elicio’s Board, did not receive any additional compensation for his service as a director.
The cash compensation approved by Elicio’s Board is as follows:
$35,000 annual base compensation for non-employee directors, and $15,000 additional compensation for the chair of Elicio’s board of directors. When a director joins the board of directors, such director will receive pro-rata cash compensation
based on his or her expected service during the fiscal year.
In addition, Elicio’s Board grants stock options to members of
Elicio’s Board upon such member’s initial election to Elicio’s Board. Thereafter, Elicio’s Board periodically grants stock options to existing directors.
In connection with the Merger, Elicio’s Board may approve new
compensation arrangements for its board of directors. The terms of any such arrangements are not yet known.
Incentive Compensation Plans
Elicio’s Board and stockholders previously adopted the Elicio 2012
Plan. Elicio’s Board and stockholders also previously adopted Elicio’s 2022 Equity Plan.
The following descriptions of the Elicio 2012 Plan and the Elicio
2022 Plan are qualified by reference to the full text of those plans, which are included as exhibits to the registration statement of which this prospectus is a part.
Elicio’s 2012 Plan
Elicio’s 2012 Plan was approved by Elicio’s Board and stockholders
in July 2012, and expired by its terms in July 2022.
Authorized Shares. The Elicio 2012 Plan will continue to govern outstanding awards granted thereunder. As of December 31, 2022 options to purchase an aggregate of 12,533,093 shares of Elicio’s common stock, and restricted stock units covering
12,533,093 shares of Elicio’s common stock, were outstanding under the Elicio 2012 Plan, and no shares of Elicio’s common stock were reserved for future grants under Elicio’s 2012 Plan.
Plan Administration. Elicio’s Board or a committee thereof has the authority to manage and control the administration of the Elicio 2012 Plan. In particular, the administrator has the authority to determine the persons to whom awards are granted and the
number of shares of Elicio’s common stock underlying each award. In addition, the administrator has the authority to determine the specific terms and conditions of each award under the Elicio 2012 Plan, to interpret the Elicio 2012 Plan, and
to prescribe, amend and rescind rules and regulations relating to the Elicio 2012 Plan. The administrator also has the authority to accelerate the exercisability or vesting of any award under the Elicio 2012 Plan.
281
Stock Options. The Elicio 2012 Plan permitted Elicio to grant stock options that are non-qualified stock options and to grant stock options that are intended to qualify as incentive stock options under Section 422 of the Code. Non-qualified stock
options may be issued to employees, non-employee directors, and consultants of Elicio’s and Elicio’s applicable affiliates, while incentive stock options may only be granted to employees of Elicio and its parent or subsidiary corporations as
defined in Sections 424(e) and 424(f) of the Code, as applicable. The terms of each option shall not exceed ten years, unless the option holder owns, or is deemed to own, stock comprising more than ten percent of the total combined voting
power of all classes of Elicio’s common stock (Ten Percent Owner), in which case the term shall not exceed five years. No option may have an exercise price less than 100% of the fair market value of a share of Elicio’s common stock on the
date of grant, and no incentive stock option granted to a Ten Percent Owner may have an exercise price less than 110% of the fair market value of a share of Elicio’s common stock on the date of grant. The Elicio 2012 Plan permits stock option
holders to exercise their stock options with the payment of cash or check, or by such other means as the administrator may approve. After the termination of service of an employee, director, consultant or other service provider for any reason
other than for cause, as defined in the Elicio 2012 Plan, the participant may exercise his or her option, to the extent vested as of the date of termination, within 90 days of termination or, if such termination is on account of death or
disability, within 12 months of termination. If such termination is for cause, then vested options terminate and may not be exercised. Except as provided by the administrator and as permissible under applicable law, the Elicio 2012 Plan does
not permit the transferability of awards and only the recipient of the option may exercise an award during his or her lifetime.
Restricted Stock Units (RSUs). The Elicio 2012 Plan permitted Elicio to grant RSUs. RSUs may be issued to Elicio’s employees, non-employee directors, and consultants and will be subject to vesting terms and other terms and conditions determined
by the administrator. RSUs granted under the Elicio 2012 Plan may be settled in cash or shares of Elicio’s common stock, or a combination thereof.
Restricted Stock. The Elicio 2012 Plan permitted Elicio to grant restricted stock awards. Restricted stock awards may be issued to Elicio’s employees, non-employee directors, and consultants and will be subject to forfeiture on terms determined by the
administrator. The purchase price for the shares of restricted stock will be determined by the administrator and may be paid for in cash, other property or services, or any combination determined by the administrator.
Stock Grants.
The Elicio 2012 Plan permitted Elicio to grant stock awards to employees, non-employee directors, and consultants of Elicio that are not subject to forfeiture of any kind.
Elicio’s 2022 Plan
Elicio’s 2022 Plan was approved by Elicio’s Board and stockholders in
October 2022.
Authorized Shares. The Elicio 2022 Plan will continue to govern outstanding awards granted thereunder. As of December 31, 2022, options to purchase an aggregate of 34,613,728 shares of Elicio’s common stock, and restricted stock units covering
34,613,728 shares of Elicio’s common stock, were outstanding under the Elicio 2022 Plan, and an additional aggregate of 4,314,323 shares of Elicio’s common stock were reserved for future grants under Elicio’s 2022 Plan.
Plan Administration. Elicio’s Board or a committee thereof has the authority to manage and control the administration of the Elicio 2022 Plan. In particular, the administrator has the authority to determine the persons to whom awards are granted and the
number of shares of Elicio’s common stock underlying each award. In addition, the administrator has the authority to determine the specific terms and conditions of each award under the Elicio 2022 Plan, to interpret the Elicio 2022 Plan, and
to prescribe, amend and rescind rules and regulations relating to the Elicio 2022 Plan. The administrator also has the authority to accelerate the exercisability or vesting of any award under the Elicio 2022 Plan. Elicio’s Board may amend or
terminate the Elicio 2022 Plan at any time, subject to compliance with applicable law.
Stock Options. The Elicio 2022 Plan permits Elicio to grant stock options that are non-qualified stock options and to grant stock options that are intended to qualify as incentive stock options under Section 422 of the Code. Non-qualified stock
options may be issued to employees, non-employee directors, and consultants of Elicio’s and Elicio’s applicable affiliates, while incentive stock options may only be granted to employees of Elicio and its parent or subsidiary corporations as
defined in Sections 424(e) and 424(f) of the Code, as applicable. The terms of each option shall not exceed ten years, unless the option holder owns, or is deemed to own, stock comprising more than ten percent of the total combined voting
power of all classes of Elicio’s common stock, a Ten Percent Owner, in
282
which case the term shall not exceed five years. No option may have an exercise
price less than 100% of the fair market value of a share of Elicio’s common stock on the date of grant, and no incentive stock option granted to a Ten Percent Owner may have an exercise price less than 110% of the fair market value of a share
of Elicio’s common stock on the date of grant. The Elicio 2022 Plan permits stock option holders to exercise their stock options with the payment of cash or check, or by such other means as the administrator may approve. After the termination
of service of an employee, director, consultant or other service provider for any reason other than for cause, as defined in the Elicio 2022 Plan, the participant may exercise his or her option, to the extent vested as of the date of
termination, within 90 days of termination or, if such termination is on account of death or disability, within 12 months of termination. If such termination is for cause, then vested options terminate and may not be exercised. Except as
provided by the administrator and as permissible under applicable law, the Elicio 2022 Plan does not permit the transferability of awards and only the recipient of the option may exercise an award during his or her lifetime.
Restricted Stock Units. The Elicio 2022 Plan permits Elicio to grant RSUs. RSUs may be issued to Elicio’s employees, non-employee directors, and consultants and will be subject to vesting terms and other terms and conditions determined by
the administrator. RSUs granted under the Elicio 2022 Plan may be settled in cash or shares of Elicio’s common stock, or a combination thereof.
Restricted Stock. The Elicio 2022 Plan permits Elicio to grant restricted stock awards. Restricted stock awards may be issued to Elicio’s employees, non-employee directors, and consultants and will be subject to forfeiture on terms determined by the
administrator. The purchase price for the shares of restricted stock will be determined by the administrator and may be paid for in cash, other property or services, or any combination determined by the administrator.
Stock Grants.
The Elicio 2022 Plan permits Elicio to grant stock awards to employees, non-employee directors, and consultants of Elicio that are not subject to forfeiture of any kind.
283
Related Person Transactions Policy and Procedures
The Angion Board has adopted a related party transaction policy
setting forth the policies and procedures for the identification, review and approval or ratification of related party transactions. This policy covers, with certain exceptions set forth in Item 404 of Regulation S-K under the Securities Act,
any transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which Angion and a related party were or will be participants and the amount
involved exceeds $120,000, including purchases of goods or services by or from the related party or entities in which the related party has a material interest, indebtedness and guarantees of indebtedness. In reviewing and approving any such
transactions, Angion’s audit committee will consider all relevant facts and circumstances as appropriate, such as the purpose of the transaction, the availability of other sources of comparable products
or services, whether the transaction is on terms comparable to those that could be obtained in an arm’s length transaction, management’s recommendation with respect to the proposed related party transaction, and the extent of the related
party’s interest in the transaction.
Certain Related Person Transactions
The following is a summary of transactions since January 1, 2021
to which Angion has been a party, in which the amount involved exceeded or will exceed the lesser of (x) $120,000 or (y) 1% of Angion’s total assets at December 31, 2022, and in which any of Angion’s directors, executive officers or holders of
more than 5% of Angion’s capital stock, or an affiliate or immediate family member thereof, had or will have a direct or indirect material interest other than compensation and other arrangements that
are described in the section titled “Angion Executive Compensation.” Also described below certain other transactions with Angion’s directors, former directors,
executive officers and stockholders.
All of the transactions set forth below were approved by a
majority of the Angion Board. Angion believes it has executed all of the transactions set forth below on terms no less favorable to Angion than it could have obtained from unaffiliated third parties. It
is Angion’s intention to ensure that all future transactions between Angion and its officers, directors and principal stockholders and their affiliates are
approved by Angion’s audit committee, and a majority of the members of the Angion Board, including a majority of the independent and disinterested members of the Angion Board, and are on terms no less
favorable to Angion than those that it could obtain from unaffiliated third parties.
Convertible Note Financings
The table below sets forth the principal amount, and number of
shares of issuable upon conversion of the convertible notes issued and outstanding as of December 31, 2020, to Angion’s directors, executive officers or owners of more than 5% of a class of Angion’s capital stock, or an affiliate or immediate
family member thereof, in connection with Angion’s initial public offering of its common stock in February 2021:
|
Name
|
| |
Convertible Note Issued(1)
and Outstanding as of
December 31, 2020
(Principal Amount)
|
| |
Number of Shares
of Angion’s
Common Stock
Issuable Upon
Conversion(2)
|
|
Gilbert S. Omenn, M.D., Ph.D.(2)
|
| |
$661,540
|
| |
61,657
|
|
Jay R. Venkatesan, M.D.(3)(4)
|
| |
$1,806,965
|
| |
165,356
|
|
Victor F. Ganzi, J.D(3)(5)
|
| |
$747,671
|
| |
68,863
|
|
Karen Wilson(6)
|
| |
$200,000
|
| |
18,718
|
|
Vifor (International) Ltd.(7)
|
| |
$5,000,000
|
| |
433,143
|
|
(1)
|
The terms of the convertible notes provide that the notes and accrued dividends will convert at a price that is equal to a 20%
discount to the price of Angion common stock offered in Angion’s initial public offering. The number of shares reflected are based on an initial public offering price of $16.00 per share and assumed the conversion occurs on February 9,
2021.
|
|
(2)
|
Dr. Omenn is a member of the Angion Board. Upon Angion’s initial public offering in February 2021, all of the convertible
notes held by Dr. Omenn’s were converted into 61,657 shares of Angion common stock. Amount shown includes Convertible Notes held by the Gilbert S. Omenn Revocable Trust, an estate planning instrument for which Dr. Omenn is trustee.
|
284
|
(3)
|
Consists of shares of Angion common stock converted from both convertible notes outstanding and convertible preferred stock
outstanding.
|
|
(4)
|
Dr. Venkatesan is Angion’s chief executive officer and Chairman of the Angion Board. During 2020, Dr. Venkatesan purchased
$950,000 in convertible notes, and in August 2021 $1.8 million in convertible notes purchased by Dr. Venkatesan in 2019 and 2020 were exchanged into preferred convertible notes, all of which were then converted into 165,094 shares of
Angion common stock upon Angion’s initial public offering in February 2021.
|
|
(5)
|
Mr. Ganzi is a member of the Angion Board.
|
|
(6)
|
Ms. Wilson is a member of the Angion Board.
|
|
(7)
|
Vifor (International) Ltd. is Angion’s licensing partner.
|
Transactions with NovaPark LLC
Prior to March 2023, Angion rented office and laboratory space in
Uniondale, New York from NovaPark, an affiliated company, under a lease expiring on June 20, 2026. The space Angion rented is part of the NovaPark Facility for biological and chemistry research owned by NovaPark. Angion recorded rent expense
for fixed lease payments of $1.2 million and $1.1 million for years ended December 31, 2022 and 2021, respectively. Angion recorded rent expense for variable expenses related to the lease of $0.4 million and $0.5 million for the years ended
December 31, 2022 and 2021.
In March 2023, Angion entered into a Surrender Agreement with
NovaPark pursuant to which (a) it paid to NovaPark a termination fee of $3.03 million, and (b) it thereby entered into a Membership Interest Redemption Agreement pursuant to which Angion relinquished its 10% membership interest in NovaPark. The
Surrender Agreement provides that, except for the payment of the termination fee described above, no other rent or charges (whether or not now accruing or in arrears) will be due from Angion with respect to any period prior to or subsequent to
the surrender of the Property to NovaPark, thereby relieving Angion of rent payments equal to approximately $3.86 million, plus other amounts for facility fees and utilities with respect to the Property. Prior to entering into the Membership
Interest Redemption Agreement, Angion owned, Dr. Goldberg and Rina Kurz, Dr. Goldberg’s spouse, owned 10%, 45% and 45%, respectively, of the membership interests in NovaPark LLC.
Consultant Fees and Employment of Immediate
Family
Angion has paid consulting fees under an agreement with Rina Kurz,
Dr. Goldberg’s spouse, for management and administrative services relating to Angion’s U.S. government grants and contracts. For the year ended December 31, 2022, consultant fees paid to Ms. Kurz were immaterial. Angion believes the consulting
arrangement with Ms. Kurz was made on terms no less favorable to Angion than those Angion could obtain from unaffiliated third parties. Angion terminated Ms. Kurz’s consultant agreement in February 2022.
Elisha Goldberg, Dr. Goldberg’s son, who formerly served as
Angion’s Vice President and Director of Strategy, was separated from his employment with Angion on January 31, 2022 as part of Angion’s reduction in force announced in January 2022. For the year ended December 31, 2022, Elisha Goldberg was paid
$0.3 million in salary and other compensation pursuant to Mr. Goldberg’s separation agreement with Angion dated March 1, 2022 Pursuant to the terms of the Separation Agreement, Mr. Goldberg will receive total severance benefits of approximately
$0.4 million. Mr. Goldberg also had the right to exercise vested stock options he received under our Amended and Second Restated 2015 Equity Incentive Plan or our 2021 Incentive Award Plan for an extended period of 11 months, until December 31,
2022. None of the vested stock options were exercised by Mr. Goldberg.
Ohr Investment
Angion and the family of Dr. Goldberg own approximately 2.4% and
78.7%, respectively, of the membership interests in Ohr, an affiliated company. Dr. Goldberg’s son, Elisha Goldberg, is the manager of Ohr. In addition, Dr. Venkatesan and Mr. Ganzi each own approximately 1.6% of the membership interests in
Ohr.
In November 2013, Angion granted Ohr an exclusive worldwide
license, with the right to sublicense, under Angion's patent rights covering one of Angion's CYP26 inhibitors, ANG-3522, for the use in treating conditions of the skin or hair. Sublicensees may not grant further sublicenses under Angion's
patent rights other than to affiliates of such sublicensees and entities with which sublicensees are collaborating for the research, development, manufacture and commercialization of the products. Ohr will pay Angion a royalty at a rate in the
low single digits on gross revenue of products incorporating ANG-3522, and milestone payments potentially totaling up to $9.0 million based on achievement of sales milestones. Royalties and milestone payments will be paid until the later of
15 years from the first commercial sale of a licensed product or the last to expire licensed patent rights. The royalty rate is subject to adjustments under certain circumstances. Angion believes the Ohr License was made on terms no
285
less favorable to Angion than those Angion could obtain from unaffiliated third
parties. On February 5, 2023, Angion and Ohr executed the First Amendment to the Ohr license agreement. Such amendment allows Ohr access to Angion’s CYP26 inhibitors beyond ANG-3522 for the use in of treating conditions of the skin and hair,
eliminates Angion’s obligation to prosecute or maintain the patents rights licensed to Ohr at its principal expense, and allows Ohr to prosecute and maintain such patent rights its sole own expense. No revenue from this license agreement was
recognized in 2022 and 2021.
Director Independence
The Angion Board currently consists of six members. The Angion
Board has determined all of Angion’s directors, other than Dr. Venkatesan and Dr. Goldberg, qualify as “independent” directors in accordance with Nasdaq listing requirements. Dr. Venkatesan and Dr. Goldberg are not considered independent
because they were employees of Angion in 2022 and 2021. As of March 2022, Dr. Goldberg was no longer an employee of Angion. In addition, as required by Nasdaq rules, the Angion Board has made a subjective determination as to each independent
director that no relationships exist that, in the opinion of the Angion Board, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In making these determinations, the Angion Board
reviewed and discussed information provided by the directors and Angion with regard to each director’s business and personal activities and relationships as they may relate to Angion and its management. There are no family relationships among
any of Angion’s directors or executive officers.
Indemnification
Angion provides indemnification for its directors and executive
officers so that they will be free from undue concern about personal liability in connection with their service to Angion. Under Angion’s Bylaws, Angion is required to indemnify its directors and executive officers to the extent not prohibited
under Delaware or other applicable law. Angion has also entered into indemnity agreements with certain officers and directors. These agreements provide, among other things, that Angion will indemnify the officer or director, under the
circumstances and to the extent provided for in the agreement, for expenses, damages, judgments, fines and settlements he or she may be required to pay in actions or proceedings which he or she is or may be made a party by reason of his or her
position as a director, officer or other agent of Angion, and otherwise to the fullest extent permitted under Delaware law and Angion’s Bylaws.
Convertible Notes and Initial Series B Preferred Stock Financing
Between 2015 and 2017, Elicio entered into convertible promissory
note agreements with investors for an aggregate amount of $4.6 million (Initial Bridge Notes). During 2018, Elicio entered into convertible promissory note agreements with investors for an aggregate principal amount of approximately $18.2
million (2018 Notes). In August 2018, at an initial closing of a private placement (Series B Private Placement) for Elicio’s Series B Preferred Stock, par value $0.001 per share (Series B Preferred Stock), Elicio entered into a Series B
Preferred Stock Purchase Agreement pursuant to which Elicio issued and sold to investors an aggregate of 2,100,000 shares of Series B Preferred Stock at a purchase price of $1.00 per share, for aggregate consideration of approximately
$2.1 million. The principal amount of the Initial Bridge Notes and the 2018 Notes, together with interest thereon in an aggregate amount of approximately $24.0 million, was automatically converted into shares of Elicio’s Series B Preferred
Stock and warrants to purchase shares of Elicio’s common stock. No Initial Bridge Notes or 2018 Notes remain outstanding.
The participants in the Initial Bridge Notes and 2018 Notes
financings and the initial closing of the Series B Private Placement included the following holders of more than 5% of Elicio’s capital stock or entities affiliated with them:
|
Participants
|
| |
Aggregate
Principal
Amount
|
| |
Shares of
Series B
Preferred Stock
Received on
Conversion
of Notes
|
| |
Warrants to
Purchase
Shares of
Common Stock
Received on
Conversion
of Notes(1)
|
|
Clal Biotechnology Industries, Ltd.
|
| |
$6,347,701
|
| |
9,399,504
|
| |
2,349,872
|
286
|
(1)
|
Warrants with ten-year term to purchase 1⁄4 of a share of common stock at an exercise price of $1.10
per full share were issued in connection with each share of Series B Preferred Stock issued.
|
At additional closings of the Series B Private Placement held
between February 2019 and February 2021 (Follow-on Series B Closings), Elicio issued and sold an aggregate of 40,482,491 additional shares of Series B Preferred Stock at a purchase price of $1.00 per share, for aggregate gross proceeds of
approximately $40.5 million. The participants in these follow-on closings of the Series B Private Placement included the following holders of more than 5% of Elicio’s capital stock or entities affiliated with them:
|
Participants
|
| |
Shares of Series B
Preferred Stock
|
| |
Warrants to
Purchase Shares of
Common Stock(2)
|
|
Clal Biotechnology Industries, Ltd.
|
| |
2,000,000
|
| |
—
|
|
(2)
|
No warrants were issued to investors after the additional closings in 2019.
|
Convertible Notes and Series C Preferred Stock Financing
In October and November 2021, Elicio entered into convertible
promissory note agreements with investors for an aggregate amount of approximately $14.5 million (Series C Bridge Notes). In May 2022, at an initial closing (Initial Closing) of a private placement (Series C Private Placement) for Elicio’s
Series C Preferred Stock, par value $0.001 per share (Series C Preferred Stock), Elicio entered into a Series C Preferred Stock Purchase Agreement pursuant to which Elicio issued and sold to investors an aggregate of 812,498 shares of Series
C-1 Preferred Stock at a purchase price of $1.20 per share, for aggregate consideration of approximately $1.0 million. At additional closings of the Series C Private Placement held between June 2022 and September 2022 (Follow-on Series C
Closings), Elicio issued and sold an aggregate of 8,350,374 additional shares of Series C-1 Preferred Stock at a purchase price of $1.20 per share, for aggregate gross proceeds of approximately $10.0 million. On October 18, 2022 (Conversion
Date), Elicio entered into Amendment No. 1 to the Series C Preferred Stock Purchase Agreement pursuant to which Elicio adjusted the shares of Series C-1 Preferred Stock previously sold at the Initial Closing and the Follow-On Series C Closings
to reflect a revised per share purchase price of $0.2576, such that the aggregate shares of Series C-1 Preferred Stock previously sold at the Initial Closing and Follow-on Series C Closing increased from 9,162,873 to an aggregate of 42,684,209
shares of Series C-1 Preferred Stock and, Elicio issued and sold an aggregate of 42,701,862 additional shares of Series C-1 Preferred Stock at a purchase price of $0.2576 per share, for additional aggregate proceeds of approximately $11.0
million. On the Conversion Date, the principal amount of the Series C Bridge Notes, together with interest thereon in an aggregate amount of approximately $15.6 million, was automatically converted into shares of Elicio’s Series C-2 Preferred
Stock. No Series C Bridge Notes remain outstanding. On November 1, 2022, Elicio issued and sold an aggregate of 1,242,235 shares of Series C-1 Preferred Stock at a purchase price of $0.2576 per share, for additional aggregate proceeds of
approximately $0.3 million.
The participants in the Series C Bridge Notes financings and the
closings of the Series C Private Placement included the following holders of more than 5% of Elicio’s capital stock or entities affiliated with them:
|
Participants
|
| |
Aggregate
Principal &
Interest
Amount
|
| |
Shares of
Series C-2
Preferred
Stock
Received on
Conversion
of Notes
|
|
Clal Biotechnology Industries, Ltd.
|
| |
$2,165,699
|
| |
10,507,999
|
|
Dreavent 3, a Series of Dreavent Master, LLC
|
| |
$12,251,015
|
| |
59,442,089
|
|
Participants
|
| |
Shares of
Series C-1
Preferred
Stock
|
|
Dreavent 5 LP
|
| |
37,928,775
|
|
Dreavent 5 II LP
|
| |
6,987,577
|
287
Investors’ Rights Agreement
In connection with the Series C Private Placement, Elicio entered
into a Second Amended and Restated Investors’ Rights Agreement, dated as of May 12, 2022, as further amended by that certain Amendment No. 1 to the Second Amended and Restated Investors’ Rights Agreement, effective as of October 18, 2022, which
provides, among other things, that certain holders of Elicio’s capital stock, including Elicio’s principal stockholders, have the right to demand that Elicio file a registration statement or request that their shares of Elicio capital stock be
covered by a registration statement that Elicio is otherwise filing. Upon the Closing, all provisions relating to these rights and covenants, as well as all provisions relating to registration rights, will terminate.
Right of First Refusal
In connection with the Series C Private Placement, Elicio entered
into a Second Amended and Restated Right of First Refusal and Co-Sale Agreement dated as of May 12, 2022, (ROFR), which provides, among other things, to certain holders of Elicio capital stock, including Elicio’s principal stockholders, a right
of first refusal and co-sale agreement. Pursuant to the ROFR, Elicio has a right to purchase shares of Elicio capital stock which stockholders propose to sell to other parties and certain holders of Elicio capital stock, including Elicio’s
principal stockholders, have a secondary right to purchase shares of Elicio capital stock which stockholders propose to sell to other parties. The ROFR will terminate upon the Closing.
Voting Agreement
In connection with the Series C Private Placement, Elicio entered
into a Second Amended and Restated Voting Agreement, dated as of May 12, 2022, as further amended by that certain Amendment No. 1 to the Second Amended and Restated Voting Agreement, effective as of October 18, 2022, pursuant to which certain
holders of Elicio capital stock, including certain holders of 5% of Elicio capital stock and entities affiliated with certain of Elicio’s directors, have agreed to, among other things, vote in a certain way on certain matters, including with
respect to the election of directors. Upon the Closing, the Voting Agreement will terminate and none of Elicio’s stockholders will have any special rights regarding the election or designation of members of the board of directors.
Elicio has also entered into Support Agreements in connection with
the Merger with certain directors, executive officers and 5% stockholders, and their affiliates. For a description of these Support Agreements, please see the section titled “Agreements Related to the
Merger—Support Agreements” in this proxy statement/prospectus/information statement.
Information Rights Agreement
Elicio entered into an information rights agreement with Clal
Biotechnology Industries (CBI) a holder of greater than 5% of Elicio’s capital stock and an entity affiliated with Assaf Segal, a member of Elicio’s Board. This agreement requires Elicio to provide CBI its annual and quarterly financial
statements, auditor consent letters and other information reasonably required by CBI to enable it to prepare its financial statements. This agreement also requires that Elicio provide CBI with information that is material to Elicio in order for
CBI to comply with disclosure and other Israeli Securities Law requirements.
Agreements with Directors and Officers
Indemnification Agreements
Elicio has entered into indemnification agreements with certain of
its directors and executive officers. The indemnification agreements will require Elicio to indemnify these individuals to the fullest extent not prohibited by Delaware law. There is no pending litigation or proceeding naming any of Elicio’s
directors or officers to which indemnification is being sought, and Elicio is not aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer.
Loan to Executive Officer
In September 2020, Elicio issued a recourse note to Robert
Connelly, Elicio’s Chief Executive Officer, in connection with Mr. Connelly’s exercise of an option to purchase 2,154,276 shares of Elicio common stock at $0.18 per share that was awarded in 2018. The principal amount of the note was
approximately $0.2 million, which accrued interest at a rate of 0.35% per annum, compounded semi-annually. The note was repaid in full in June 2021.
288
Danforth Advisors Consulting Agreement
On March 13, 2013, Elicio entered into a Consulting Agreement with
Danforth Advisors, LLC (Danforth). Daniel Geffken, Elicio’s interim Chief Financial Officer, is a managing director of Danforth. The agreement provides for Danforth to provide chief financial officer services, business consulting and advisory
services, including accounting and controller services that are necessary to support the management and operations of Elicio’s business. The agreement remains in effect until such time as either party has given notice of termination and may be
terminated by either party for cause upon 30 days’ prior written notice to the other party or for convenience upon 60 days’ prior written notice to the other party. The agreement has been amended in each of 2014, 2016, 2019, 2020 and 2021 to
modify the scope of services provided. As consideration under the agreement, Elicio pays Danforth consulting fees generally based on hourly rates as enumerated in the agreement, or for specific agreed upon fees for specific projects/services.
Elicio paid Danforth approximately $0.4 million and $0.7 million for its services in 2022 and 2021, respectively. Mr. Geffken receives grants of options to purchase common stock from time to time in his capacity a consultant and, separately,
receives additional grants in his capacity as a member of Elicio’s Board. Mr. Geffken has not received any options to purchase shares of Elicio common stock in connection with this service as a consultant. For more information regarding these
grants, see the section titled “Elicio Executive and Director Compensation.”
Policies and Procedures for Related Party Transactions
While Elicio does not have a formal written policy or procedure
for the review, approval or ratification of related party transactions, the Elicio Board reviews and considers the interests of its directors, executive officers and principal stockholders in its review and consideration of transactions and
obtains the approval of non-interested directors when it determines that such approval is appropriate under the circumstances.
289
The following summary describes Angion’s
capital stock and the material provisions of Angion’s amended and restated certificate of incorporation and amended and restated bylaws, and of the DGCL. Because the following is only a summary, it does not contain all of the information that
may be important to you. For a complete description, you should refer to Angion’s amended and restated certificate of incorporation and amended and restated bylaws, copies of which have been filed as exhibits to the registration statement of
which this prospectus is part.
Angion’s authorized capital stock consists of 300,000,000 shares
of common stock, $0.01 par value per share, and 10,000,000 shares of preferred stock, $0.01 par value per share. A description of material terms and provisions of Angion’s certificate of incorporation and bylaws affecting the rights of holders
of Angion’s capital stock is set forth below. The description is intended as a summary, and is qualified in its entirety by reference to Angion’s certificate of incorporation and the bylaws.
Common stock
Voting Rights. Each holder of Angion common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including the election of directors. Angion’s stockholders do not have cumulative voting rights in
the election of directors. Accordingly, holders of a majority of the voting shares are able to elect all of the directors. In addition, the affirmative vote of holders of 662∕3% of the voting power of all of the then outstanding voting stock
is required to take certain actions, including amending certain provisions of Angion’s amended and restated certificate of incorporation, such as the provisions relating to amending Angion’s amended
and restated bylaws, the classified board and director liability.
Dividends.
Subject to preferences that may be applicable to any then outstanding preferred stock, holders of Angion common stock are entitled to receive dividends, if any, as may be declared from time to time by the Angion Board out of legally available
funds.
Liquidation.
In the event of a liquidation, dissolution or winding up of Angion, holders of Angion common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of Angion’s
debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of any then outstanding shares of preferred stock.
Rights and Preferences. Holders of Angion common stock have no preemptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions applicable to Angion common stock. The rights, preferences and
privileges of the holders of Angion common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of Angion’s preferred stock that Angion may designate in the future.
Fully Paid and Nonassessable. Angion’s outstanding shares of common stock are fully paid and nonassessable.
Preferred stock
The Angion Board is authorized, subject to limitations prescribed
by Delaware law, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each series and to fix the designation, powers, preferences and rights of the
shares of each series and any of its qualifications, limitations or restrictions. The Angion Board can also increase or decrease the number of shares of any series, but not below the number of shares of that series then outstanding, without any
further vote or action by Angion’s stockholders. The Angion Board may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of the common stock.
The issuance of preferred stock, while providing flexibility in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring, discouraging or preventing a change in
control of Angion and may adversely affect the market price of Angion common stock and the voting and other rights of the holders of common stock.
Anti-Takeover Effects of Provisions of Angion’s Amended and Restated
Certificate of Incorporation, Angion’s Amended and Restated Bylaws and Delaware Law
Certain provisions of Delaware law and Angion’s amended and
restated certificate of incorporation and amended and restated bylaws contain provisions that could make the following transactions more difficult: acquisition of Angion by means of a tender offer; acquisition of Angion by means of a proxy
contest or otherwise; or removal of
290
Angion’s incumbent officers and directors. It is possible that these provisions
could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in Angion’s best interests, including transactions that might result in a premium over the market
price for Angion’s shares.
These provisions, summarized below, are expected to discourage
coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of Angion to first negotiate with the Angion Board. Angion believes that the benefits of increased
protection of its potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure Angion outweigh the disadvantages of discouraging these proposals because negotiation of these proposals
could result in an improvement of their terms.
Delaware Anti-Takeover Statute
Angion is subject to Section 203 of the DGCL which prohibits
persons deemed “interested stockholders” from engaging in a “business combination” with a publicly held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or
the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an “interested stockholder” is a person who, together with affiliates and associates,
owns or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or stock sale or other transaction
resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to transactions not approved in advance by the board of directors, such as discouraging takeover
attempts that might result in a premium over the market price of Angion common stock.
Undesignated Preferred Stock
The ability to authorize undesignated preferred stock makes it
possible for the Angion Board to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control of Angion. These and other provisions may have the effect of deterring hostile
takeovers or delaying changes in control or management of Angion.
Special Stockholder Meetings
Angion’s amended and restated bylaws provide that a special
meeting of stockholders may be called at any time by the Angion Board or the chairperson of the Angion Board or Angion’s President or Chief Executive Officer, but such special meetings may not be called by the stockholders or any other person
or persons.
Requirements for Advance Notification of
Stockholder Nominations and Proposals
Angion’s amended and restated bylaws establish advance notice
procedures with respect to stockholder proposals and the nomination of candidates for election as directors, other than nominations made by or at the direction of the Angion Board or a committee of the Angion Board.
Elimination of Stockholder Action by Written
Consent
Angion’s amended and restated certificate of incorporation and
amended and restated bylaws eliminate the right of stockholders to act by written consent without a meeting.
Classified Board; Election and Removal of
Directors; Filling Vacancies
The Angion Board is divided into three classes. The directors in
each class will serve for a three-year term, one class being elected each year by Angion’s stockholders, with staggered three-year terms. Only one class of directors will be elected at each annual meeting of Angion’s stockholders, with the
other classes continuing for the remainder of their respective three-year terms. Because Angion’s stockholders do not have cumulative voting rights, Angion’s stockholders holding a majority of the shares of Angion common stock outstanding will
be able to elect all of Angion’s directors. Angion’s amended and restated certificate of incorporation provides for the removal of any of Angion’s directors only for cause and requires a stockholder vote by the holders of at least a 662/3% of
the voting power of the then outstanding voting stock. Furthermore, any vacancy on the Angion Board, however occurring,
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including a vacancy resulting from an increase in the size of the Angion Board,
may only be filled by a resolution of the Angion Board unless the Angion Board determines that such vacancy shall be filled by the stockholders. This system of electing and removing directors and filling vacancies may tend to discourage a third
party from making a tender offer or otherwise attempting to obtain control of Angion, because it generally makes it more difficult for stockholders to replace a majority of the directors.
Choice of Forum
Angion’s amended and restated certificate of incorporation and
amended and restated bylaws provide that, unless Angion consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the exclusive forum for the following types of actions or proceedings
under Delaware statutory or common law: any derivative action or proceeding brought on Angion’s behalf; any action asserting a claim of breach of fiduciary duty owed by any of Angion’s directors, officers or stockholders to Angion or to
Angion’s stockholders; any action asserting a claim against Angion arising pursuant to DGCL, Angion’s amended and restated certificate of incorporation or Angion’s amended and restated bylaws (as either may be amended from time to time); or any
action asserting a claim against Angion that is governed by the internal affairs doctrine. As a result, any action brought by any of Angion’s stockholders with regard to any of these matters will need to be filed in the Court of Chancery of the
State of Delaware and cannot be filed in any other jurisdiction; provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal
courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or
federal court sitting in the State of Delaware. Angion’s amended and restated certificate of incorporation and amended and restated bylaws also provide that the federal district courts of the United States of America will be the exclusive forum
for the resolution of any complaint asserting a cause of action against Angion or any of Angion’s directors, officers, employees or agents and arising under the Securities Act. Nothing in Angion’s amended and restated certificate of
incorporation and amended and restated bylaws preclude stockholders that assert claims under the Exchange Act from bringing such claims in state or federal court, subject to applicable law.
If any action the subject matter of which is within the scope
described above is filed in a court other than a court located within the State of Delaware (Foreign Action) in the name of any stockholder, such stockholder shall be deemed to have consented to the personal jurisdiction of the state and
federal courts located within the State of Delaware in connection with any action brought in any such court to enforce the applicable provisions of Angion’s amended and restated certificate of incorporation and amended and restated bylaws and
having service of process made upon such stockholder in any such action by service upon such stockholder’s counsel in the Foreign Action as agent for such stockholder. Although Angion’s amended and restated certificate of incorporation and
amended and restated bylaws contain the choice of forum provision described above, it is possible that a court could find that such a provision is inapplicable for a particular claim or action or that such provision is unenforceable.
This choice of forum provision may limit a stockholder’s ability
to bring a claim in a judicial forum that it finds favorable for disputes with Angion or any of Angion’s directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims, although Angion’s
stockholders will not be deemed to have waived Angion’s compliance with federal securities laws and the rules and regulations thereunder.
Amendment of Charter Provisions
The amendment of any of the above provisions in Angion’s amended
and restated certificate of incorporation, except for the provision making it possible for the Angion Board to issue undesignated preferred stock, would require approval by a stockholder vote by the holders of at least a 662/3% of the voting
power of the then outstanding voting stock.
The provisions of the DGCL, Angion’s amended and restated
certificate of incorporation and Angion’s amended and restated bylaws could have the effect of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of
Angion’s common stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes in Angion’s management. It is possible that these provisions could make it more difficult
to accomplish transactions that Angion stockholders may otherwise deem to be in their best interests.
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Limitation of Liability and Indemnification
Matters
Angion’s amended and restated certificate of incorporation
contains provisions that limit the liability of Angion’s directors for monetary damages to the fullest extent permitted by Delaware law. Consequently, Angion’s directors will not be personally liable to Angion or its stockholders for monetary
damages for any breach of fiduciary duties as directors, except liability for:
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any breach of the director’s duty of loyalty to Angion or its stockholders;
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any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
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unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL; or
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any transaction from which the director derived an improper personal benefit.
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Each of Angion’s amended and restated certificate of incorporation
and amended and restated bylaws provide that Angion is required to indemnify its directors and officers, in each case to the fullest extent permitted by Delaware law. Angion’s amended and restated bylaws also obligate Angion to advance expenses
incurred by a director or officer in advance of the final disposition of any action or proceeding, and permit Angion to secure insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her
actions in that capacity regardless of whether Angion would otherwise be permitted to indemnify him or her under Delaware law. Angion has entered and expects to continue to enter into agreements to indemnify its directors, executive officers
and other employees as determined by the Angion Board. With specified exceptions, these agreements provide for indemnification for related expenses including, among other things, attorneys’ fees, judgments, fines and settlement amounts incurred
by any of these individuals in any action or proceeding. Angion believes that these bylaw provisions and indemnification agreements are necessary to attract and retain qualified persons as directors and officers. Angion also maintains
directors’ and officers’ liability insurance.
The limitation of liability and indemnification provisions in
Angion’s amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from bringing a lawsuit against Angion’s directors and officers for breach of their fiduciary duty. They may also reduce the
likelihood of derivative litigation against Angion’s directors and officers, even though an action, if successful, might benefit Angion and its stockholders. Further, a stockholder’s investment may be adversely affected to the extent that
Angion pays the costs of settlement and damages.
Transfer Agent and Registrar
The transfer agent and registrar for Angion common stock is
Continental Stock Transfer & Trust Company. The transfer agent and registrar’s address is 1 State Street, 30th Floor, New York, New York 10004.
Listing on the Nasdaq Global Select Market
Angion common stock is listed on the Nasdaq Global Select Market
the symbol “ANGN.”
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General
Elicio and Angion are both incorporated under the laws of the
State of Delaware. The rights of Elicio stockholders and Angion stockholders are generally governed by the DGCL. Upon completion of the Merger, Elicio stockholders will become Angion stockholders, and their rights will be governed by the DGCL,
the amended and restated bylaws of Angion and the amended and restated certificate of incorporation of Angion, as amended.
The material differences between the current rights of Elicio
stockholders under Elicio’s amended and restated certificate of incorporation and bylaws and their rights as Angion stockholders, after the Merger, under Angion’s amended and restated certificate of incorporation and its amended and restated
bylaws, both as will be in effect immediately following the completion of the Merger, are summarized below. The summary below does not purport to be complete and is subject to, and qualified in its entirety by reference to, the DGCL and the
governing corporate instruments that are subject to amendment in accordance with their terms. You should carefully read this entire document and the other referenced documents, including the governing corporate instruments, for a more complete
understanding of the differences between being a stockholder of Elicio or Angion before the Merger and being a Angion stockholder following the completion of the Merger. For more information on how to obtain these documents, see the section
titled “Where You Can Find More Information” beginning on page 307 of this proxy statement/prospectus/information statement.
Elicio
Elicio’s amended and restated certificate of incorporation
authorizes the issuance of up to 520,000,000 shares of common stock, $0.01 par value per share, and 347,902,276 shares of preferred stock, $0.001 par value per share (Elicio Preferred Stock), of which 5,000,000 shares are designated Series A
Preferred Stock, 72,802,898 shares are designated Series B Preferred Stock, 194,099,378 shares are designated Series C-1 Preferred Stock, and 76,000,000 shares are designated Series C-2 Preferred Stock. The Elicio Series C-1 Preferred Stock and
Elicio Series C-2 Preferred Stock are together referred to herein as Elicio Series C Preferred Stock.
Angion
Angion’s authorized capital stock consists of 300,000,000 shares
of common stock, $0.01 par value per share, and 10,000,000 shares of preferred stock, $0.01 par value per share.
The Merger Agreement contemplates an amendment to Angion’s amended
and restated certificate of incorporation in connection with the closing of the Merger to implement the Reverse Stock Split.
Conversion Rights and Protective Provisions
Elicio
The amended and restated certificate of incorporation of Elicio
provides that each holder of shares of Elicio Preferred Stock shall, subject to certain conditions, have the right to convert such shares into shares of Elicio common stock at any time in accordance with the amended and restated certificate of
incorporation of Elicio. Each share of Elicio Preferred Stock is convertible into 1.00 share of Elicio common stock. The applicable conversion rates of each series of Elicio Preferred Stock are subject to further adjustment if Elicio issues
additional shares of Elicio common stock at a price per share below the applicable conversion price of a series of Elicio Preferred Stock, subject to certain customary exceptions. The current conversion prices of the Elicio Preferred Stock are:
$0.6836 for the Elicio Series A Preferred Stock, $0.6836 for the Elicio Series B Preferred Stock, $0.2576 for the Elicio Series C-1 Preferred Stock, and $0.2061 for the Elicio Series C-2 Preferred Stock.
The amended and restated certificate of incorporation of Elicio
provides that for so long as at least 68,924,848 shares of Elicio Preferred Stock shall be outstanding, Elicio shall not, either directly or indirectly by amendment, merger, consolidation or otherwise, do any of the following without the
written consent or affirmative vote of the holders of a majority of the outstanding shares of Elicio Preferred Stock, voting together on a single class and on an as-converted to Elicio common stock basis, given in writing or by vote at a
meeting: (a) (i) liquidate, dissolve or wind-up the business and affairs of Elicio, (ii) effect any Deemed Liquidation Event (as defined in Elicio’s amended and restated certificate of incorporation), (iii) sell, lease, license or otherwise
dispose of all or a material
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portion of the assets or inventory of Elicio (other than in the ordinary course of
business); (b) amend, alter or repeal any provision of Elicio’s amended and restated certificate of incorporation or bylaws; (c) alter or change the rights, preferences or privileges of the Elicio Preferred Stock; (d) create, or authorize the
creation of, or issue or obligate itself to issue shares of, any additional class or series of capital stock unless the same ranks junior to the Series C Preferred Stock with respect to the distribution of assets on the liquidation, dissolution
or winding up of Elicio, the payment of dividends and rights of redemption, other than additional shares of Series C Preferred Stock; (e) increase the authorized number of shares of the Preferred Stock or increase the authorized number of
shares of any other class or series of capital stock of Elicio (f) (i) reclassify, alter or amend any existing security of Elicio that is pari passu to the Elicio Preferred Stock with respect to the distribution of assets on the liquidation,
dissolution or winding up of Elicio, the payment of dividends and rights of redemption, if such reclassification, alteration or amendment would render such other security senior to any of the Elicio Preferred Stock in respect of any such right,
preference or privilege or (ii) reclassify, alter or amend any existing security of Elicio that is junior to the Preferred Stock in respect of the distribution of assets upon the liquidation, dissolution or winding up of Elicio, the payment of
dividends or rights of redemption, if such reclassification, alteration or amendment would render such other security senior to or pari passu with any of the Preferred Stock in respect of any such right, preference or privilege; (g) purchase or
redeem (or permit any subsidiary to purchase or redeem) or pay or declare any dividend or make any distribution on, any shares of capital stock of the other than (i) redemptions of or dividends or distributions on the Elicio Preferred Stock as
expressly authorized in Elicio’s amended and restated certificate of incorporation, and (ii) repurchases of stock from former employees, officers, directors, consultants or other persons who performed services for Elicio or any subsidiary in
connection with the cessation of such employment or service at the lower of the original purchase price or the then current fair market value thereof; (h) incur any indebtedness for borrowed money, or create, or authorize the creation of, or
issue, or authorize the issuance of, any debt security, or permit any subsidiary to take any such action, if the aggregate indebtedness of Elicio and its subsidiaries for borrowed money following such action would exceed $500,000, except where
approved in advance by the Elicio Board including the affirmative vote of all of the Series A Directors, all of the Series B Directors and at least one (1) Series C Director (each as defined in Elicio’s amended and restated certificate of
incorporation and together, the “Required Elicio Directors); (i) create, or hold capital stock in, any subsidiary that is not wholly owned (either directly or through one or more subsidiaries) by Elicio, or sell, transfer or otherwise dispose
(directly or indirectly) of any capital stock of any direct or indirect subsidiary of Elicio, or permit any direct or indirect subsidiary to sell, lease, transfer, exclusively license or otherwise dispose (in a single transaction or a series of
related transactions) of all or substantially all of the assets of such subsidiary; (j)(i) increase the aggregate number of shares of Elicio common stock authorized for issuance to employees or directors of, or consultants or advisors to,
Elicio or any of its subsidiaries pursuant to any stock option or other equity incentive plan, (ii) create any such stock option or other equity incentive plan or (iii) grant shares of Elicio common stock, stock options or other securities of
Elicio to employees or directors of, or consultants or advisors to, Elicio or any of its subsidiaries except pursuant to Elicio’s 2012 Equity Incentive Plan or 2022 Equity Incentive Plan, except where approved in advance by the Elicio Board
including the affirmative vote or consent of all of the Required Elicio Directors; (k) increase or decrease the authorized number of directors constituting the Elicio Board; (1) accelerate, or provide for the acceleration of, the vesting
schedule of any stock option or restricted stock award, except in the case where any such acceleration is provided for in any written agreement entered into by Elicio prior to first issuance of Elicio Series C Preferred Stock or where any such
acceleration has been approved by the Elicio Board including the affirmative vote of the Required Elicio Directors; (m) appoint, hire, terminate or remove the Chief Executive Officer and the Chief Financial Officer, except in the case where any
such hire or termination has been approved by the Elicio Board including the affirmative vote or consent of the Required Elicio Directors; (n) effect any material change m the principal business of Elicio; (o) acquire the stock or other equity
interests or all or substantially all of the assets of another entity, except in the case where any such acquisition has been approved by the Elicio Board including the affirmative vote of the Required Elicio Directors and; (p) permit any
direct or indirect subsidiary of Elicio to take any action, or fail to prohibit or prevent any direct or indirect subsidiary of Elicio from taking any action, that Elicio would be prohibited from taking under any of the foregoing clauses
(a)-(o) if such action were being taken by Elicio; and (q) commit, agree, resolve to take, or make an agreement (whether oral or written) to commit, agree or resolve to take, or cause any officers or employees to commit, agree or resolve to
take, any of the actions described in the foregoing clauses (a)-(p).
Angion
Holders of Angion common stock have no preemptive, conversion,
subscription or other rights, and there are no redemption or sinking fund provisions applicable to Angion common stock. The rights, preferences and privileges of
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the holders of Angion common stock are subject to and may be adversely affected by
the rights of the holders of shares of any series of Angion preferred stock that it may designate in the future.
Angion’s Board is authorized, subject to limitations prescribed by
Delaware law, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each series and to fix the designation, powers, preferences and rights of the shares
of each series and any of its qualifications, limitations or restrictions. Angion’s Board can also increase or decrease the number of shares of any series, but not below the number of shares of that series then outstanding, without any further
vote or action by the company’s stockholders. Angion’s Board may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of the common stock. The
issuance of preferred stock, while providing flexibility in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring, discouraging or preventing a change in control of
Angion and may adversely affect the market price of Angion’s common stock and the voting and other rights of the holders of common stock.
Number of Directors
Elicio
Elicio’s bylaws provide that the number of directors shall be set
from time to time by the Elicio Board and shall be no less than one and not more than thirteen directors. Elicio’s amended and restated certificate of incorporation provides for the election of nine directors and that in no event shall the
maximum amount of directors be less than five.
Angion
Angion’s amended and restated certificate of incorporation and
amended and restated bylaws provide that, subject to any special rights of the holders of any series of preferred stock to elect directors, Angion’s authorized number of directors shall be determined from time to time by resolution of the
Angion Board. The Angion Board currently has six members.
Stockholder Nominations and Proposals
Elicio
None.
Angion
Angion’s amended and restated bylaws provide that stockholders
seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner and also specify requirements as to the form and
content of a stockholder’s notice.
Classification of Board of Directors
Elicio
Elicio’s amended and restated certificate of incorporation and
bylaws do not provide for the division of the Elicio Board into staggered classes.
Angion
Angion’s amended and restated certificate of incorporation
provides that the directors shall be divided into three classes, with each class having a three-year term expiring on a staggered basis.
Removal of Directors
Elicio
Elicio’s bylaws provide that, any director may be removed from the
Elicio Board at any time, with or without cause, by the holders of a majority of the shares then entitled to vote in an election of directors.
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The Voting Agreement provides that the board of directors shall
consist of (1) one individual designated by the holders of a majority of the outstanding shares of Elicio Preferred Stock, (2) two individuals designated by the holders of a majority of the outstanding shares of Series A Preferred Stock, voting
separately as a class, (3) two individuals designated by the holders of a majority of the outstanding shares of Series B Preferred Stock, voting separately as a class, (4) two individuals designated by the holders of a majority of the
outstanding shares of Series C Preferred Stock, voting separately as a class, (5) one individual who is an industry expert (approved by the Series A Directors and Series B Directors), and (6) Elicio’s chief executive officer. If any director
resigns or is removed, they shall be replaced by a person nominated in accordance with the previous sentence. The Voting Agreement will be terminated immediately prior to the Effective Time, without any liability being imposed on the part of
Angion or the surviving company.
Angion
Angion’s certificate of incorporation provides that, except as may
otherwise be provided by the DGCL and subject to the special rights of the holders of any series of preferred stock to elect directors, any individual Angion director may be removed only for cause and requires a stockholder vote by the holders
of at least a two-thirds of the voting power of the then outstanding voting stock.
Vacancies on the Board of Directors
Elicio
Elicio’s bylaws provide that vacancies occurring on its board of
directors may be filled by affirmative vote of the majority of directors then in office, even if less than a quorum. If the holders of any class or classes of stock are entitled to elect one or more directors by the provisions of Elicio’s
amended and restated certificate of incorporation, a majority of the directors elected by such class or classes then in office may fill such vacancy or vacancies. Elicio’s certificate of incorporation provides that if the holders of the shares
of one or more series of voting capital stock fail to elect a sufficient number of directors to fill all directorships for which they are entitled to elect directors, voting exclusively and as a separate class, then any directorship not so
filled shall remain vacant until such time as the holders of the shares of the applicable class or series of voting capital stock entitled to elect a person to fill such directorship so elect a person to fill such directorship and the Voting
Agreement by vote or written consent in lieu of a meeting; and no such directorship may be filled by stockholders of Elicio other than by the holders of the shares of the applicable class or series of capital stock entitled to elect a person to
fill such directorship, voting exclusively and as a separate class as provided in the certificate of incorporation.
Angion
Angion’s certificate of incorporation and bylaws provide that,
subject to the rights of the holders of any series of preferred stock, any vacancies on the Board of Directors resulting from death, resignation, disqualification, removal or other causes and any newly created directorships resulting from any
increase in the number of directors, shall, unless the Board of Directors determines by resolution that any such vacancies or newly created directorships shall be filled by the stockholders, except as otherwise provided by law, be filled only
by the affirmative vote of a majority of the directors then in office, even though less than a quorum or by the sole remaining director, and not by the stockholders.
Voting Stock
Elicio
Elicio’s amended and restated certificate of incorporation
provides that every stockholder shall be entitled to one vote for each share of common stock of Elicio held by them (including all Elicio Preferred Stock on an as-converted basis) as of the record date for such meeting.
Angion
The Angion common stock is entitled to one vote for each share
held of record on all matters submitted to a vote of the stockholders.
Cumulative Voting
Elicio
Elicio’s amended and restated certificate of incorporation does not
address cumulative voting.
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Angion
Angion stockholders do not have cumulative voting rights in the
election of directors.
Stockholder Action by Written Consent
Elicio
Elicio’s bylaws provide that any action required by the DGCL or
permitted to be taken at any annual or special meeting of stockholders, may be taken without a meeting, without prior notice and without a vote, if a consent or consents in writing, setting forth the action so taken, shall be signed by the
holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted.
Angion
Angion’s amended and restated certificate of incorporation and its
amended and restated bylaws eliminated the right of stockholders to act by written consent without a meeting.
Notice of Stockholder Meeting
Elicio
Elicio’s bylaws provide that except as otherwise provided by
statute, its amended and restated certificate of incorporation, as amended, or the bylaws, notice of each annual or special meeting of the stockholders shall be given to each stockholder of record entitled to vote at such meeting not less than
ten and nor more than 60 days before the day of the meeting to each stockholder entitled to vote at such meeting. Every such notice shall state the time, place, if any, the means of remote communications, if any, by which stockholders and proxy
holders may be deemed to be present in person and vote at such meeting, and, in the case of a special meeting, no business may be transacted at such meeting except that referred to in the notice, or in a supplemental notice given also in
compliance with the provisions of the bylaws, or such other business as may be germane or supplementary to that stated in said notice or notices.
Notices may be (i) in writing and delivered personally at the
addresses appearing on Elicio’s books, (ii) by facsimile telecommunication, (iii) by electronic mail, (iv) by other electronic transmission. Notice by mail shall be deemed to be given at the time when the same shall be mailed. Notice need not
be given to any stockholder who submits a written waiver of notice signed by him or her before or after the time stated therein. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person
attends a meeting for the express purpose of objecting at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened.
Angion
Angion’s bylaws provide that written notice of a meeting of the
stockholders shall be given not less than 10 nor more than 60 days before the date of the meeting to each stockholder entitled to vote at such meeting. The notice shall specify the place, if any, date and time of the meeting, the means of
remote communication, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such meeting, and, in the case of a special meeting, the purpose or purposes for which the meeting is called.
Notice shall be given (1) if mailed, when the notice is deposited
in the U.S. mail, postage prepaid, (2) if delivered by courier service, the earlier of when the notice is received or left at such stockholder’s address or (3) if given by electronic mail, when directed to such stockholder’s electronic mail
address unless the stockholder has notified Angion in writing or by electronic transmission of an objection to receiving notice by electronic mail. A notice by electronic mail must include a prominent legend that the communication is an
important notice regarding Angion. Notice need not be given to any stockholder who submits a written waiver of notice signed by him or her before or after the time stated therein. Attendance of a person at a meeting shall constitute a waiver of
notice of such meeting, except when the person attends a meeting for the express purpose of objecting at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the
business to be transacted at, nor the purpose of, any regular or special meeting of the stockholders need be specified in any written waiver of notice or any waiver by electronic transmission unless so required by the certificate of
incorporation or bylaws.
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Special Stockholder Meetings
Elicio
Elicio’s bylaws provide that a special meeting of the stockholders
may be called at any time by the Elicio Board, Chairperson of the Elicio Board, and any President or Vice President of Elicio.
Angion
Angion’s bylaws provide that a special meeting of stockholders may
be called at any time by Angion’s Board or the chairperson of the board of directors or its President or Chief Executive Officer, but such special meetings may not be called by the stockholders or any other person or persons.
Indemnification
Elicio
Elicio has entered into separate indemnification agreements with
certain of its directors and executive officers, in addition to the indemnification provided for in Elicio’s amended and restated certificate of incorporation and bylaws. The indemnification agreements and Elicio’s amended restated certificate
of incorporation and bylaws that will be in effect upon the closing of this merger require the combined company to indemnify its directors, executive officers and certain controlling persons to the fullest extent permitted by Delaware law.
Angion
Angion’s amended and restated certificate of incorporation and
amended and restated bylaws provide that to the fullest extent permitted by law, Angion is authorized to provide indemnification any person made or threatened to be made a party to an action or proceeding, whether criminal, civil,
administrative or investigative, by reason of the fact that he, his testator or intestate is or was a director, officer or agent of Angion or any predecessor of Angion, or serves or served at any other enterprise as a director, officer or agent
at the request of Angion or any predecessor to Angion, against all liability and loss suffered and expenses reasonably incurred by such person in connection with any such action or proceeding. Angion shall be required to indemnify a person in
connection with an action or proceeding initiated by such person only if the Proceeding was authorized by the Board.
Angion has entered into separate indemnification agreements with
each of its directors and executive officers, in addition to the indemnification provided for in Angion’s amended and restated certificate of incorporation and amended and restated bylaws.
Amendment of Amended and Restated Certificate of Incorporation
Elicio
The Elicio Board and stockholders may amend, alter, change or
repeal any provision of Elicio’s amended and restated certificate of incorporation, as amended, in a manner prescribed by statue; provided that (i) any such amendment may be subject to the protective provisions described above, (ii) any repeal
or modification of Article Ninth of Elicio’s amended and restated certificate of incorporation shall not adversely affect any right or protection of any director of Elicio existing at the time of such repeal or modification or increase the
liability of any director of Elicio with respect to any acts or omissions of such director, officer or agent occurring prior to, such repeal or modification, and (iii) any amendment, repeal or modification of Article Tenth of Elicio’s amended
and restated certificate of incorporation shall not adversely affect any person existing at the time of such amendment, repeal or modification.
Angion
The amendment of any of the provisions in Angion amended and
restated certificate of incorporation, except for the provision making it possible for Angion Board to issue undesignated preferred stock, would require approval by a stockholder vote by the holders of at least a two-thirds of the voting power
of the then outstanding voting stock.
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Amendment of Amended and Restated Bylaws
Elicio
Under Elicio’s amended and restated certificate of incorporation,
the Elicio Board is expressly authorized to make, repeal, alter, amend and rescind any or all of Elicio’s bylaws, subject to the protective provisions described above. Elicio’s bylaws provide that the bylaws may be adopted, amended or repealed
by the vote of the holders of the majority of the stock entitled to vote at a meeting.
Angion
Angion’s amended and restated certificate of incorporation and
amended and restated bylaws provide that the Angion’s Board is expressly empowered to make, alter or repeal Angion’s amended and restated bylaws. Any adoption, amendment or repeal of the Angion amended and restated bylaws by Angion’s Board
shall require the approval of a majority of the authorized number of directors. Angion’s amended and restated certificate of incorporation also provides that the Angion stockholders shall also have power to make, alter or repeal Angion’s
amended and restated bylaws; provided, however, that, in addition to any vote of the holders of any class or series of stock of Angion required by law or by Angion’s amended and restated certificate of incorporation, such action by stockholders
shall require the affirmative vote of the holders of at least two-thirds of the voting power of all of the then-outstanding shares of Angion capital stock entitled to vote generally in the election of directors, voting together as a single
class.
Forum Selection
Elicio
Elicio’s amended and restated certificate of incorporation
provides that unless Elicio consents in writing to the selection of an alternative forum, the Court of Chancery in the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of
Elicio, (ii) any action asserting a claim of breach of fiduciary duty owed by any director, officer or other employee of Elicio to Elicio or its stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL or
Elicio’s amended and restated certificate of incorporation or bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine.
Angion
Angion’s certificate of incorporation and bylaws provide that,
unless Angion consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall, to the fullest extent permitted by law, be the sole and exclusive forum for (i) any derivative action or
proceeding brought on Angion’s behalf; (ii) any action asserting a breach of fiduciary duty; (iii) any action asserting a claim against Angion arising under the DGCL or its bylaws; (iv) any action asserting a claim against Angion that is
governed by the internal affairs doctrine. Angion’s amended and restated bylaws further provide that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action
arising under the Securities Act. Notwithstanding the foregoing, these forum selection provisions do not apply to suits brought to enforce any liability or duty created by the Securities Exchange Act of 1934, as amended, or any other claim for
which the federal courts of the United States have exclusive jurisdiction.
300
The following table sets forth certain information regarding the
ownership of Angion’s common stock as of April 1, 2023 by: (i) each director and nominee for director; (ii) each of the executive officers named in the Summary Compensation Table; (iii) all executive officers and directors of Angion as a group;
and (iv) all those known by Angion to be beneficial owners of more than five percent of its common stock.
|
|
| |
Beneficial Ownership
as of April 1, 2023(1)
|
|||
|
Beneficial Owner
|
| |
Number of
Shares
|
| |
Percent of
Total
|
|
5% and Greater Stockholders:
|
| |
|
| |
|
|
Jay R. Venkatesan, M.D.(2)
|
| |
2,658,296
|
| |
8.4%
|
|
Thomas A. Satterfield, Jr.(3)
|
| |
2,213,383
|
| |
7.4%
|
|
Entities associated with Vifor (International), Ltd.(4)
|
| |
1,995,643
|
| |
6.6%
|
|
EISA-ABC LLC(5)
|
| |
1,722,237
|
| |
5.7%
|
|
Itzhak D. Goldberg, M.D.(6)
|
| |
1,813,345
|
| |
6.0%
|
|
|
| |
|
| |
|
|
Named Executive Officers and Directors:
|
| |
|
| |
|
|
Jay R. Venkatesan, M.D.(2)
|
| |
2,658,296
|
| |
8.4%
|
|
Itzhak D. Goldberg, M.D.(6)
|
| |
1,813,345
|
| |
6.0%
|
|
Victor F. Ganzi, J.D.(7)
|
| |
1,032,593
|
| |
3.4%
|
|
Jennifer J. Rhodes, J.D.(8)
|
| |
364,247
|
| |
1.2%
|
|
John Neylan, M.D.(9)
|
| |
35,136
|
| |
*
|
|
Gilbert S. Omenn, M.D., Ph.D.(10)
|
| |
134,221
|
| |
*
|
|
Karen J. Wilson(11)
|
| |
72,613
|
| |
*
|
|
Allen R. Nissenson, M.D.(12)
|
| |
63,278
|
| |
*
|
|
All executive officers and directors as a group (9 persons)(13)
|
| |
6,370,254
|
| |
19.6%
|
|
*
|
Less than one percent.
|
|
(1)
|
This table is based upon information supplied by officers, directors and principal stockholders and Schedules 13D and 13G
filed with the SEC. Unless otherwise indicated in the footnotes to this table and subject to community property laws where applicable, Angion believes that each of the stockholders named in this table has sole voting and investment
power with respect to the shares indicated as beneficially owned. Applicable percentages are based on 30,113,484 shares outstanding on April 1, 2023, adjusted as required by rules promulgated by the SEC. Unless otherwise noted below,
the address for persons listed in the table is c/o Angion Biomedica Corp. 7-57 Wells Avenue, Newton, Massachusetts 02459.
|
|
(2)
|
Consists of (i) 1,192,730 shares of Angion’s common stock held directly by Jay R. Venkatesan, M.D., (ii) 1,460,798 shares of
Angion’s common stock that may be acquired pursuant to the exercise of stock options within 60 days of April 1, 2023, and (iii) 4,768 shares of Angion’s common stock held by the Venkatesan Family Trust.
|
|
(3)
|
Based upon a Schedule 13G/A filed on February 10, 2023 as of December 31, 2022, Mr. Satterfield has sole voting and investment
power with respect to 308,647 of these shares, and shared voting and investment power with respect to 1,904,796 of these shares.With respect to the beneficial ownership reported for Thomas A. Satterfield, Jr., 300,000 shares are held by
Tomsat Investment & Trading Co., Inc., a corporation controlled by Mr. Satterfield and of which he serves as President; 732,178 shares are held by Caldwell Mill Opportunity Fund, which fund is managed by an entity of which Mr.
Satterfield owns a 50% interest and serves as Chief Investment Manager; and 600,000 shares are held by A.G. Family L.P., a partnership managed by a general partner controlled by Mr. Satterfield. Additionally, Mr. Satterfield has limited
powers of attorney for voting and disposition purposes with respect to the following securities: Satterfield Vintage Investments LP (200,000 shares and 15,558 warrants); Rebecca A. Satterfield (25,000 shares); and George and Laura
Thaggard Pontikes (32,000 shares). These individuals and entities have the right to receive or the power to direct the receipt of the proceeds from the sale of their respective shares. The address for Mr. Satterfield is 15 Colley Cove
Drive, Gulf Breeze, FL 32561.
|
|
(4)
|
The shares are owned directly by Vifor (International) Ltd., a Swiss joint stock corporation, which is a wholly owned
subsidiary of Vifor Pharma Participations Ltd., a Swiss joint stock corporation, which is a wholly owned subsidiary of Vifor Pharma Ltd., a Swiss joint stock corporation. Vifor Pharma Ltd. is a wholly owned subsidiary of CSL Behring AG,
a Swiss joint stock corporation, which is a wholly owned subsidiary of CSL Behring Holdings Limited, an English private limited company. CSL Behring Holdings Limited is a wholly owned subsidiary of CSL Behring (Holdings) Pty Ltd, an
Australian private limited company, which is a wholly owned subsidiary of CSL Limited, an Australian public limited company listed on the Australian Securities Exchange (ASX). Each of Vifor Pharma Participations Ltd., Vifor Pharma Ltd.,
CSL Behring AG, CSL Behring Holdings Limited, CSL Behring (Holdings) Pty Ltd and CSL Limited may be deemed to beneficially own the shares by virtue of the relationships described above. Voting and investment decisions are made by
management at the direction of the Board of Directors of CSL Limited. The Board of Directors of CSL Limited comprisea nine members, which exercises its voting and dispositive power by majority vote. The address of CSL Limited is 45
Poplar Road, Parkville VIC 3052, Australia. The address for Vifor (International) Ltd. is Rechenstrasse 37, CH-9014 St. Gallen, Switzerland.
|
|
(5)
|
Based upon information provided by EISA-ABC. The address of EISA-ABC, LLC is 41 Brayton Street, Englewood, NJ 07631.
|
301
|
(6)
|
Consists of (i) 1,687,986 shares of Angion’s common stock held directly by Dr. Goldberg, and (ii) 125,359 shares of Angion’s
common stock that may be acquired pursuant to the exercise of stock options within 60 days of April 1, 2023. The address of Dr. Goldberg is 41 Brayton Street, Englewood, NJ 07631.
|
|
(7)
|
Consists of (i) 823,117 shares of Angion’s common stock held directly by Victor F. Ganzi, J.D., (ii) 155,581 shares of
Angion’s common stock held by Victor F Ganzi 2012 GST Family Trust held by Victor Ganzi, and (iii) 53,895 shares of Angion’s common stock that may be acquired pursuant to the exercise of stock options within 60 days of April 1, 2023.
|
|
(8)
|
Consists of (i) 14,597 shares of Angion’s common stock held directly by Jennifer J. Rhodes, J.D., and (ii) 349,650 that may be
acquired pursuant to the exercise of stock options within 60 days of April 1, 2023.
|
|
(9)
|
Consists solely of shares of Angion’s common stock held directly by John Neylan, M.D.
|
|
(10)
|
Consists of (i) 80,326 shares of Angion’s common stock held by the Gilbert S. Omenn Revocable Trust, and (ii) 53,895 shares of
common stock that may be acquired pursuant to the exercise of stock options within 60 days of April 1, 2023.
|
|
(11)
|
Consists of (i) 18,718 shares of Angion’s common stock held directly by Karen Wilson, and (ii) 53,895 shares of Angion’s
common stock that may be acquired pursuant to the exercise of stock options within 60 days of April 1, 2023.
|
|
(12)
|
Consists of (i) 9,383 shares of Angion’s common stock held directly by Allen R. Nissenson, and (ii) 53,895 shares of Angion’s
common stock that may be acquired pursuant to the exercise of stock options within 60 days of April 1, 2023.
|
|
(13)
|
Consists of the shares described in footnotes 6 through 12 above, plus (i) 4,000 shares of Angion’s common stock held directly
by Greg Curhan, and (ii) 192,525 that may be acquired pursuant to the exercise of stock options within 60 days of April 1, 2023.
|
302
The following table sets forth certain information with respect to
the beneficial ownership of Elicio common stock, on an as-converted to common stock basis, as of April 1, 2023, for:
|
•
|
each person, or group of affiliated persons, known by Elicio to beneficially own more than 5% of Elicio’s outstanding shares
of Elicio capital stock;
|
|
•
|
each of Elicio’s directors;
|
|
•
|
each of Elicio’s named executive officers; and
|
|
•
|
all directors and executive officers of Elicio as a group.
|
The number of shares beneficially owned by each entity, person,
director or executive officer is determined in accordance with the rules of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership includes any shares
over which the individual has sole or shared voting power or investment power as well as any shares that the individual has the right to acquire within 60 days of April 1, 2023 through the exercise of stock options or other rights. Except as
otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all shares of capital stock held by that person.
The percentage of shares beneficially owned is computed on the
basis of 294,501,766 shares of Elicio common stock outstanding as of April 1, 2023, after giving effect to the automatic conversion of all 240,132,083 shares of Elicio preferred stock outstanding as of April 1, 2023, into 276,142,623 shares of
Elicio common stock and includes 18,359,143 shares of Elicio common stock outstanding as of April 1, 2023. Shares of Elicio common stock that a person has the right to acquire within 60 days of April 1, 2023, are deemed outstanding for purposes
of computing the percentage ownership of the person holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person, except with respect to the percentage ownership of all directors and
executive officers as a group. Unless noted otherwise, the address of all listed stockholders is 451 D Street, 5th Floor, Suite 501, Boston, MA 02210.
|
|
| |
Beneficial Ownership
as of April 1, 2023
|
|||
|
Beneficial Owner
|
| |
Number of
Shares
|
| |
Percent of
Total
|
|
5% and Greater Stockholders:
|
| |
|
| |
|
|
Clal Biotechnology Industries, Ltd.(1)
|
| |
38,097,783
|
| |
12.78%
|
|
Funds affiliated with Dreavent, Inc.(2)
|
| |
104,358,441
|
| |
35.44%
|
|
GKCC, LLC(3)
|
| |
38,819,875
|
| |
13.18%
|
|
|
| |
|
| |
|
|
Directors and Named Executive Officers:
|
| |
|
| |
|
|
Julian Adams, Ph.D.(4)
|
| |
2,804,007
|
| |
*
|
|
Carol Ashe(5)
|
| |
761,281
|
| |
*
|
|
Yekaterina (Katie) Chudnovsky(3)(6)
|
| |
39,069,875
|
| |
13.26%
|
|
Robert Connelly(7)
|
| |
12,267,067
|
| |
4.03%
|
|
Daniel Geffken(8)
|
| |
1,359,610
|
| |
*
|
|
Christopher Haqq, M.D., Ph.D.(9)
|
| |
8,584,438
|
| |
2.86%
|
|
Annette Matthies, Ph.D.(10)
|
| |
3,951,710
|
| |
1.32%
|
|
Daphne Karydas(11)
|
| |
761,281
|
| |
*
|
|
Robert Ruffolo, Jr., Ph.D.(12)
|
| |
881,104
|
| |
*
|
|
Assaf Segal(13)
|
| |
250,000
|
| |
*
|
|
All executive officers and directors as a group (11 persons)(14)
|
| |
75,604,576
|
| |
23.18%
|
|
*
|
Represents beneficial ownership of less than 1%.
|
|
(1)
|
Consists of (i) 7,314,219 shares of Elicio common stock issuable upon the conversion of 5,000,000 shares of Elicio Series A
preferred stock, (ii) 16,675,693 shares of Elicio common stock issuable upon the conversion of 11,399,504 shares of Elicio Series B preferred stock, (iii) 10,507,999 shares of Elicio common stock issuable upon the conversion of
10,507,999 shares of Elicio Series C preferred stock, and (iv) 3,599,872 shares of our common stock subject to warrants that may be exercised within 60 days of April 1, 2023. Clal Industries Ltd.
|
303
owns 48.49% of the outstanding shares of Clal Biotechnology Industries, Ltd., or
CBI (TASE: CBI). Teva Pharmaceutical Industries Ltd owns 15.89% of the outstanding shares of CBI. Clal Industries Ltd. is wholly-owned (indirectly) by Access Industries and, which is controlled by Mr. Len Blavatnik. Assaf Segal, a member of
Elicio’s board of directors, is the Chief Executive Officer of CBI, but does not have voting or investment control over the securities of Elicio owned by CBI. The address of CBI is 3 Azrieli Center, 45th Floor, Triangle Tower, 132 Menachem
Begin Road, Tel Aviv 6702301, Israel.
|
(2)
|
Consists of (i) 59,442,089 shares of Elicio common stock issuable upon the conversion of 59,442,089 shares of Elicio Series C
preferred stock held by Dreavent 3, a Series of Dreavent Master, LLC (“Dreavent 3”), (ii) 37,928,775 shares of Elicio common stock issuable upon the conversion of 37,928,775 shares of Elicio Series C preferred stock held by Dreavent 5,
LP, (“Dreavent 5”) and (iii) 6,987,577 shares of Elicio common stock issuable upon the conversion of 6,987,577 shares of Elicio Series C preferred stock held by Dreavent 5 II LP (“Dreavent 5 II”). Assure Fund Management II, LLC is the
Administrative Manager of Dreavent 3, Dreavent 5 and Dreavent 5 II. Dreavent, Inc. is the manager of Dreavent 3 and the general partner of Dreavent 5 and Dreavent 5 II. Gorka Fius is the sole stockholder of Dreavent, Inc. and may be
deemed to beneficially own the shares held by Dreavent 3, Dreavent 5 and Dreavent 5 II. Mr. Fius disclaims beneficial ownership of the shares held by Dreavent 3, Dreavent 5 and Dreavent 5 II, except to the extent of his pecuniary
interest therein, if any. The address of Dreavent 3, Dreavent 5 and Dreavent 5 II is One Broadway, Cambridge, MA 02142.
|
|
(3)
|
Consists of 38,819,875 shares of Elicio common stock issuable upon the conversion of 38,819,875 shares of Elicio Series C
preferred stock. Yekaterina (Katie) Chudnovsky is the sole member and manager of GKCC, LLC and may be deemed to beneficially own the shares held by GKCC, LLC. The address of GKCC, LLC is 501 Silverside Road, Suite 87AVA, Wilmington, DE
19809.
|
|
(4)
|
Consists of 2,804,007 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(5)
|
Consists of 761,281 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(6)
|
Consists of 250,000 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023; see
footnote 3.
|
|
(7)
|
Consists of (i) 2,595,072 shares of common stock, and (ii) 9,671,995 shares of Elicio common stock subject to options that are
exercisable within 60 days of April 1, 2023.
|
|
(8)
|
Consists of 1,359,610 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(9)
|
Consists of: (i) 300,000 shares of Elicio common stock, of which 154,167 shares are subject to forfeiture pursuant to an early
exercise of a stock option prior to vesting, (ii) 2,265,565 shares underlying restricted stock units and (iii) 6,018,873 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(10)
|
Consists of 3,951,710 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(11)
|
Consists of 761,281 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(12)
|
Consists of 881,104 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(13)
|
Consists of 250,000 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023.
Assaf Segal, a member of Elicio’s board of directors, is the Chief Executive Officer of CBI, but does not have voting or investment control over the securities of Elicio owned by CBI.
|
|
(14)
|
Consists of (i) 43,980,512 shares of Elicio common stock (including 2,265,565 shares underlying restricted stock units) held
by Elicio’s executive officers and directors, and (ii) 31,624,064 shares of Elicio common stock subject to options that are exercisable within 60 days of April 1, 2023. Includes 4,914,203 shares of common stock subject to options that
are exercisable within 60 days of April 1, 2023, held by Pete DeMuth, Chief Scientific Officer.
|
304
The following table and the related notes present certain
information with respect to the beneficial ownership of the common stock of the combined company upon consummation of the Merger, assuming the closing of the Merger occurred on April 1, 2023, by: (i) each person or group of affiliated persons
known by Elicio or Angion to become the beneficial owner of more than 5% of the common stock of the combined company upon the closing of the Merger; (ii) each of the directors of the combined company; (iii) each of the executive officers of the
combined company; and (iv) all executive officers and directors of the combined company as a group.
Unless otherwise indicated in the footnotes to this table, Elicio
and Angion believe that each of the persons named in this table have sole voting and investment power with respect to the shares indicated as beneficially owned.
The following table assumes (i) no exercise of outstanding options
to purchase shares of Angion common stock or Elicio common stock prior to the closing of the Merger, (ii) an Exchange Ratio of 0.0164, (iii) that the closing of the Merger occurred on April 1, 2023, and (iv) a Reverse Stock Split of 10-for-1,
to be implemented immediately prior to the closing of the Merger. Based on these assumptions, there will be a total of 8,732,351 shares of combined company common stock outstanding upon the closing of the Merger, after giving effect to the
Reverse Stock Split.
Shares of the combined company’s common stock that may be acquired
by an individual or group within 60 days of April 1, 2023, pursuant to the exercise of options or warrants, are deemed to be outstanding for the purpose of computing the percentage ownership of such individual or group, but are not deemed to be
outstanding for the purpose of computing the percentage ownership of the combined company’s common stock of any other person shown in the table. Unless otherwise indicated, the address for the following stockholders is: c/o Elicio Therapeutics,
Inc., 451 D Street, 5th Floor, Suite 501, Boston, MA 02210.
|
|
| |
Beneficial Ownership
as of April 1, 2023
|
|||
|
Beneficial Owner
|
| |
Number of
Shares
|
| |
Percent of
Total
|
|
5% and Greater Stockholders:
|
| |
|
| |
|
|
Clal Biotechnology Industries, Ltd.(1)
|
| |
624,804
|
| |
7.11%
|
|
Funds affiliated with Dreavent, Inc.(2)
|
| |
1,711,478
|
| |
19.60%
|
|
GKCC, LLC(3)
|
| |
636,646
|
| |
7.29%
|
|
|
| |
|
| |
|
|
Directors and Named Executive Officers:
|
| |
|
| |
|
|
Robert Connelly(4)
|
| |
201,180
|
| |
2.26%
|
|
Daniel Geffken(5)
|
| |
22,298
|
| |
*
|
|
Christopher Haqq, M.D., Ph.D.(6)
|
| |
140,785
|
| |
1.59%
|
|
Annette Matthies, Ph.D.(7)
|
| |
64,808
|
| |
*
|
|
Jay R. Venkatesan, M.D.(8)
|
| |
265,829
|
| |
3.04%
|
|
Julian Adams, Ph.D.(9)
|
| |
45,986
|
| |
*
|
|
Carol Ashe(10)
|
| |
12,485
|
| |
*
|
|
Daphne Karydas(11)
|
| |
12,485
|
| |
*
|
|
Assaf Segal(12)
|
| |
4,100
|
| |
*
|
|
Yekaterina (Katie) Chudnovsky(13)
|
| |
640,746
|
| |
7.33%
|
|
Karen J. Wilson(14)
|
| |
7,261
|
| |
*
|
|
Allen R. Nissenson, M.D.(15)
|
| |
6,328
|
| |
*
|
|
All executive officers and directors as a group (13 persons)(16)
|
| |
1,504,624
|
| |
15.96%
|
|
*
|
Represents beneficial ownership of less than 1%.
|
|
(1)
|
Consists of (i) 565,766 shares of the combined company’s common stock, and (ii) 59,038 shares of the combined company’s common
stock subject to warrants that may be exercised within 60 days of April 1, 2023. Clal Industries Ltd. owns 48.49% of the outstanding shares of Clal Biotechnology Industries, Ltd., or CBI (TASE: CBI). Teva Pharmaceutical Industries Ltd
owns 15.89% of the outstanding shares of CBI. Clal Industries Ltd. is wholly-owned (indirectly) by Access Industries and, which is controlled by Mr. Len Blavatnik. Assaf Segal is the Chief Executive Officer of CBI but does not have
voting or investment control over the securities of the combined company owned by CBI. The address of CBI is 3 Azrieli Center, 45th Floor, Triangle Tower, 132 Menachem Begin Road, Tel Aviv 6702301, Israel.
|
|
(2)
|
Consists of (i) 974,850 shares of the combined company’s common stock to be held by Dreavent 3, (ii) 622,032 shares of the
combined company’s common stock to be held by Dreavent 5 and (iii) 114,596 shares of the combined company’s common stock to be held by
|
305
Dreavent 5 II. Assure Fund Management II, LLC is the Administrative Manager of
Dreavent 3, Dreavent 5 and Dreavent 5 II. Dreavent, Inc. is the manager of Dreavent 3 and the general partner of Dreavent 5 and Dreavent 5 II. Gorka Fius is the sole stockholder of Dreavent, Inc. and may be deemed to beneficially own the shares
held by Dreavent 3, Dreavent 5 and Dreavent 5 II. Mr. Fius disclaims beneficial ownership of the shares held by Dreavent 3, Dreavent 5 and Dreavent 5 II, except to the extent of his pecuniary interest therein, if any. The address of Dreavent 3,
Dreavent 5 and Dreavent 5 II is One Broadway, Cambridge, MA 02142.
|
(3)
|
Consists of 636,646 shares of the combined company’s common stock. Yekaterina (Katie) Chudnovsky is the sole member and
manager of GKCC, LLC and may be deemed to beneficially own the shares held by GKCC, LLC. The address of GKCC, LLC is 501 Silverside Road, Suite 87AVA, Wilmington, DE 19809.
|
|
(4)
|
Consists of (i) 42,559 shares of the combined company’s common stock, and (ii) 158,621 shares of the combined company’s common
stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(5)
|
Consists of 22,298 shares of the combined company’s common stock subject to options that are exercisable within 60 days of
April 1, 2023.
|
|
(6)
|
Consists of (i) 39,546 shares of the combined company’s common stock, (ii) 2,529 shares of the combined company’s; common
stock subject to forfeiture pursuant to an early exercise of a stock option prior to vesting, and (iii) 98,710 shares of the combined company’s common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(7)
|
Consists of 64,808 shares of the combined company’s common stock subject to options that are exercisable within 60 days of
April 1, 2023.
|
|
(8)
|
Consists of (i) 119,273 shares of the combined company’s common stock held directly by Jay R. Venkatesan, M.D., (ii) 146,080
shares of the combined company’s common stock that may be acquired pursuant to the exercise of stock options within 60 days of April 1, 2023, and (iii) 476 shares of the combined company’s common stock held by the Venkatesan Family
Trust.
|
|
(9)
|
Consists of 45,986 shares of the combined company’s common stock subject to options that are exercisable within 60 days of
April 1, 2023.
|
|
(10)
|
Consists of 12,485 shares of the combined company’s common stock subject to options that are exercisable within 60 days of
April 1, 2023.
|
|
(11)
|
Consists of 12,485 shares of the combined company’s common stock subject to options that are exercisable within 60 days of
April 1, 2023.
|
|
(12)
|
Consists of 4,100 shares of the combined company’s common stock subject to options that are exercisable within 60 days of
April 1, 2023. Assaf Segal is the Chief Executive Officer of CBI but does not have voting or investment control over the securities of the combined company owned by CBI.
|
|
(13)
|
Consists of 4,100 shares of the combined company’s common stock subject to options that are exercisable within 60 days of
April 1, 2023; see footnote 3.
|
|
(14)
|
Consists of (i) 1,872 shares of the combined company’s common stock held directly by Karen Wilson, and (ii) 5,390 shares of
the combined company’s common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(15)
|
Consists of (i) 938 shares of the combined company’s common stock held directly by Allen R. Nissenson, and (ii) 5,390 shares
of the combined company’s common stock subject to options that are exercisable within 60 days of April 1, 2023.
|
|
(16)
|
Consists of (i) 806,685 shares of the combined company’s common stock held by the combined company’s executive officers and
directors, and (ii) 660,784 shares of the combined company’s common stock subject to options that are exercisable within 60 days of April 1, 2023. Includes 80,593 shares of the combined company’s common stock subject to options that are
exercisable within 60 days of April 1, 2023, held by Pete DeMuth, Chief Scientific Officer.
|
306
Cooley LLP will pass upon the validity of the Angion common stock
offered by this proxy statement/prospectus/information statement.
Angion
The consolidated financial statements of Angion Biomedica Corp. as
of December 31, 2022 and 2021 and for the years then ended included in this proxy statement/prospectus/information statement have been audited by Moss Adams LLP, an independent registered public accounting firm, as stated in their report. Such
consolidated financial statements are included in reliance upon the report of such firm given their authority as experts in accounting and auditing.
Elicio
The consolidated financial statements of Elicio Therapeutics, Inc.
as of December 31, 2022 and 2021 and for the years then ended included in this proxy statement/prospectus/information statement have been audited by Baker Tilly US, LLP, an independent registered public accounting firm, as stated in their
report. Such consolidated financial statements are included in reliance upon the report of such firm given their authority as experts in accounting and auditing. This report on the consolidated financial statements contains an explanatory
paragraph regarding Elicio Therapeutics, Inc.’s ability to continue as a going concern.
Angion has filed with the SEC a Registration Statement on Form S-4
(including exhibits, schedules, and amendments) under the Securities Act with respect to the shares of common stock offered by this proxy statement/prospectus/information statement. This proxy statement/prospectus/information statement is a
part of the Registration Statement and constitutes a prospectus of Angion, as well as a proxy statement of Angion for its special meeting and an information statement for the purpose of Elicio for its written consent.
This proxy statement/prospectus/information statement does not
contain all the information set forth in the Registration Statement. For further information about Angion and the shares of common stock to be registered in the Merger, you should refer to the Registration Statement. Statements contained in
this proxy statement/prospectus/information statement relating to the contents of any contract, agreement or other document are not necessarily complete and are qualified in all respects by the complete text of the applicable contract,
agreement or other document, a copy of which has been filed as an exhibit to the Registration Statement.
Angion is subject to the reporting and information requirements of
the Exchange Act and, as a result, files, or will file, periodic reports, proxy statements and other information with the SEC. The SEC maintains an internet site that contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC. The SEC’s internet site can be found at http://www.sec.gov. Angion also maintains a website at http://www.angion.com and makes available free of charge through this website Angion’s
annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act. Angion make these reports available through
Angion’s website as soon as reasonably practicable after Angion electronically files such reports with, or furnishes such reports to, the SEC. The information contained on, or that can be accessed through, Angion’s website is not a part of this
proxy statement/prospectus/information statement.
This proxy statement/prospectus/information statement does not
constitute an offer to sell, or a solicitation of an offer to purchase, the securities offered by this proxy statement/prospectus/information statement, or the solicitation of a proxy, in any jurisdiction to or from any person to whom or from
whom it is unlawful to make such offer, solicitation of an offer or proxy solicitation in such jurisdiction. Neither the delivery of this proxy statement/prospectus/information statement nor any distribution of securities pursuant to this proxy
statement/prospectus/information statement shall, under any circumstances, create any implication that there has been no change in the information set forth or incorporated into this proxy statement/prospectus/information statement by reference
or in Angion’s affairs since the date of this proxy statement/prospectus/information statement.
307
Angion has supplied all information contained in this proxy
statement/prospectus/information statement relating to Angion and its business, and Elicio has supplied all information contained in this proxy statement/prospectus/information statement relating to Elicio and its business.
If you would like to request documents from Angion or Elicio,
please send a request in writing or by telephone to either Angion or Elicio at the following addresses:
|
Angion Biomedica Corp.
|
| |
Elicio Therapeutics Inc.
|
|
|
| |
|
|
7-57 Wells Avenue
|
| |
451 D Street, 5th Floor, Suite 501
|
|
Newton, Massachusetts 02459
|
| |
Boston, MA 02210
|
|
(857) 336-4001
|
| |
(857) 209-0050
|
|
Attn: Investor Relations
|
| |
|
You may also request additional copies from Angion’s proxy solicitor using the
following contact information:
Mackenzie Partners, Inc.
1407 Broadway, New York, New York 10018
Stockholders call toll-free: 1-800-322-2885
Call Collect: 212-929-5500
Email: Angion@mackenziepartners.com
Householding of Proxy Materials
The SEC has adopted rules that permit companies and intermediaries
(e.g., brokers) to satisfy the delivery requirements for proxy statements and annual reports with respect to two or more stockholders sharing the same address by delivering a single proxy statement
addressed to those stockholders. This process, which is commonly referred to as “householding,” potentially means extra convenience for stockholders and cost savings for companies.
A number of brokers with account holders who are Angion
stockholders will be householding Angion’s proxy materials. A single proxy statement/prospectus/information statement will be delivered to multiple stockholders sharing an address unless contrary instructions have been received from the
affected stockholders. Once a stockholder has received notice from its broker that they will be householding communications to such stockholder’s address, householding will continue until such stockholder is notified otherwise or until it
revokes its consent. If, at any time, a stockholder no longer wishes to participate in householding and would prefer to receive a separate proxy statement/prospectus/information statement and annual disclosure documents, it may notify its
broker, and direct its written request to Angion Biomedica Corp. at Angion’s principal executive offices at 7-57 Wells Avenue, Newton, Massachusetts 02459, Attention: Investor Relations. Stockholders who currently receive multiple copies of the
proxy statement/prospectus/information statement and annual disclosure documents at their address and would like to request householding of their communications should contact their broker.
Stockholder Proposals
To be considered for inclusion in next year’s proxy materials,
your proposal must be submitted in writing by December 30, 2023, to Jennifer J. Rhodes, Corporate Secretary at 7-57 Wells Avenue, Newton, Massachusetts 02459. However, if Angion’s 2024 Annual Meeting of Stockholders is held before May 1,
2024, or after June 30, 2024, then the deadline will be a reasonable time prior to the time Angion makes its proxy materials available to its stockholders, either online or in printed form.
If you wish to submit a proposal (including a director
nomination) at the meeting that is not to be included in next year’s proxy materials, you must provide specified information in writing to Angion’s Corporate Secretary at the address above not later than the close of business on February 1,
2024 nor earlier than the close of business March 2, 2024; provided, however, that if the date of Angion’s 2024 Annual Meeting is before May 1, 2024 or after July 30, 2024, notice by the
stockholder to be timely must be so delivered, or mailed and received, not later than the ninetieth (90th) day prior to Angion’s 2024 Annual Meeting or, if later, the tenth (10th) day following the day on which public disclosure of the date
of Angion’s 2024 Annual Meeting was first made by Angion. You are also advised to review Angion’s Bylaws, which contain a description of the information required to be submitted, as well as additional requirements about advance notice of
stockholder proposals and director nominations.
308
Stockholder Communication with the Angion Board
Angion’s stockholders may communicate with the Board by writing to
its Corporate Secretary at Angion Biomedica Corp., 7-57 Wells Avenue, Newton, Massachusetts 02459. Angion’s Corporate Secretary will review these communications and will determine whether they should be presented to the Board. The purpose of
this screening is to allow the Board to avoid having to consider irrelevant or inappropriate communications. All communications directed to the Audit Committee in accordance with Angion’s Complaint, Investigation and Whistleblower Policy that
relate to questionable accounting or auditing matters involving Angion will be promptly and directly forwarded to the Chairman of the Audit Committee.
Code of Business Conduct and Ethics
Angion has adopted the Angion Code of Business Conduct and Ethics
applying to all officers, directors and employees. The Code of Business Conduct and Ethics is available on Angion’s website at https://ir.angion.com/corporate-governance/governance-overview. If Angion makes any substantive amendments to the
Code of Business Conduct and Ethics or grants any waiver from a provision of the Code to any executive officer or director, Angion will promptly disclose the nature of the amendment or waiver on its website.
309
On January 17, 2023, Angion entered into the Merger Agreement with
Elicio and Merger Sub. Upon the terms and subject to the satisfaction of the conditions described in the Merger Agreement, Merger Sub will be merged with and into Elicio with Elicio surviving as a wholly owned subsidiary of Angion.
At the Effective Time: (i) each share of Elicio’s capital stock
outstanding and after giving effect to the automatic conversion of all outstanding shares of Elicio’s preferred stock conversion, excluding any shares of Elicio capital stock held by Elicio, Angion, Merger Sub or any of their respective
subsidiaries and any dissenting shares, will be automatically converted solely into the right to receive a number of shares of Angion common stock (the Shares) equal to the Exchange Ratio (as defined in the Merger Agreement) and, if applicable,
an amount in cash, rounded to the nearest whole cent, in lieu of any fractional share interest in Angion common stock to which such holder otherwise would have been entitled (after aggregating all fractional shares issuable to such holder);
(ii) each option to purchase shares of Elicio capital stock (each, an Elicio Option) that is outstanding and unexercised immediately prior to the Effective Time under Elicio Plans, whether or not vested, will be converted into and become an
option to purchase Angion common stock, and Angion will assume the Elicio Plans and each such Elicio Option in accordance with the terms of the Elicio Plans and the terms of the stock option agreement by which such Elicio Option is evidenced;
and (iii) each warrant to purchase shares of Elicio capital stock (each, an Elicio Warrant) that is outstanding and unexercised immediately prior to the Effective Time will be converted into and become a warrant to purchase Angion common stock,
and Angion will assume each Elicio Warrant in accordance with its terms.
Immediately following the Merger, the pre-Merger equity holders of
Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each
case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. The Net Cash Condition means that Angion Net Cash must be no less than $25 million in order for
Elicio to be required to complete the Merger.
Angion will ask its stockholders to approve an amended and
restated certificate of incorporation, including to effect the Reverse Stock Split, which approval is also necessary to complete the transactions contemplated by the Merger Agreement. Upon the effectiveness of the amended and restated
certificate of incorporation effecting the Reverse Stock Split, the outstanding shares of Angion common stock will be combined into a lesser number of shares in the range to be determined by Angion’s Board and agreed to by Elicio prior to the
Effective Time of such amended and restated certificate of incorporation and public announcement by Angion. Because the reverse stock split ratio has not been determined, the unaudited pro forma condensed combined financial statements do not
reflect the Reverse Stock Split. Once the Reverse Stock Split has been agreed to, the unaudited pro forma condensed combined financial statement disclosures shall be revised accordingly.
The unaudited pro forma condensed combined financial information
gives effect to the Merger, which has been accounted for as a reverse recapitalization under GAAP. Elicio is considered the accounting acquirer for financial reporting purposes. This determination is based on the expectation that, immediately
following the Merger: (i) Elicio stockholders will own a substantial majority of the voting rights of the combined company; (ii) Elicio will designate a majority (six of nine) of the initial members of the board of directors of the combined
company; and (iii) Elicio’s senior management will hold all key positions in senior management of the combined company. The transaction is expected to be accounted for as a reverse recapitalization of Angion by Elicio similar to as if Elicio
had issued equity for the net assets of Angion, which are expected to be primarily cash, and other non-operating assets. It was concluded that any in process research and development assets potentially still remaining as of the Merger would be
de-minimis when compared to the cash obtained through the Merger.
As a result of Elicio being treated as the accounting acquirer,
Elicio’s assets and liabilities will be recorded at their pre-Merger carrying amounts. Angion’s assets and liabilities will be measured and recognized at their fair values as of the Effective Date of the Merger, which are expected to
approximate the carrying value of the acquired cash and other non-operating assets. Any difference between the consideration transferred and the fair value of the net assets of Angion following determination of the actual purchase consideration
for Angion will be reflected as an adjustment to additional paid-in capital. Upon consummation of the Merger, the historical financial statements of Elicio will become the historical consolidated financial statements of the combined company.
The unaudited pro forma condensed combined balance sheet data
assumes that the Merger took place on December 31, 2022, and combines the historical balance sheets of Angion and Elicio as of such date. The unaudited
PF-1
pro forma condensed combined statements of operations for the year ended
December 31, 2022 assumes that the Merger took place as of January 1, 2022 and combines the historical results of Angion and Elicio for the periods then ended. The unaudited pro forma condensed combined financial information was prepared
pursuant to the rules and regulations of Article 11 of SEC Regulation S-X, as amended.
The unaudited pro forma condensed combined financial information
is provided for illustrative purposes only, does not necessarily reflect what the actual consolidated results of operations and financial position would have been had the acquisition occurred on the dates assumed and may not be useful in
predicting the future consolidated results of operations or financial position.
The unaudited pro forma condensed combined financial information
is based on the assumptions and adjustments that are described in the accompanying notes. Accordingly, the pro forma adjustments are preliminary, subject to further revision as additional information becomes available and additional analyses
are performed and have been made solely for the purpose of providing unaudited pro forma condensed combined financial information. Differences between these preliminary accounting and estimates and the final accounting conclusions and amounts
may occur as a result of changes in initial assumptions in the determination of the accounting acquirer and related accounting, and the amount of cash used in Angion’s operations, and other changes in Angion’s assets and liabilities, which are
expected to be completed after the closing of the Merger, may occur and these differences could have a material impact on the accompanying unaudited pro forma condensed combined financial information and the combined company’s future results of
operations and financial position.
The unaudited pro forma condensed combined financial information
does not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or other savings or expenses that may be associated with the integration of the two companies. The actual results reported
in periods following the Merger may differ significantly from those reflected in the unaudited pro forma condensed combined financial information presented herein for a number of reasons, including, but not limited to, differences in the
assumptions used to prepare this unaudited pro forma condensed combined financial information.
The unaudited pro forma condensed combined financial information,
including the notes thereto, should be read in conjunction with the separate historical financial statements of Angion and Elicio, and their respective management’s discussion and analysis of financial condition and results of operations
included elsewhere in, or incorporated by reference to, this proxy statement.
Accounting rules require evaluation of certain assumptions,
estimates, or determination of financial statement classifications. The accounting policies of Angion may materially vary from those of Elicio. During preparation of the unaudited pro forma condensed combined financial information, management
has performed a preliminary analysis and is not aware of any material differences, and accordingly, this unaudited pro forma condensed combined financial information assumes no material differences in accounting policies. Following the Merger,
management will conduct a final review of Angion’s accounting policies in order to determine if differences in accounting policies require adjustment or reclassification of Angion’s results of operations or reclassification of assets or
liabilities to conform to Elicio’s accounting policies and classifications. As a result of this review, management may identify differences that, when conformed, could have a material impact on these unaudited pro forma condensed combined
financial statements.
PF-2
Unaudited Pro Forma Condensed Combined Balance Sheets
As of December 31, 2022
(In thousands)
|
|
| |
December 31, 2022
|
| |
|
| |
|
| |
|
|||
|
|
| |
Angion
Biomedica
Corp.
(Historical)
|
| |
Elicio
Therapeutics,
Inc. and
Subsidiary
(Historical)
|
| |
Transaction
Accounting
Adjustments
|
| |
Notes
|
| |
Pro
Forma
Combined
|
|
ASSETS
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Current assets:
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Cash and cash equivalents
|
| |
$50,487
|
| |
$6,156
|
| |
$—
|
| |
|
| |
$56,643
|
|
Restricted cash
|
| |
—
|
| |
1,641
|
| |
—
|
| |
|
| |
1,641
|
|
Prepaid expenses and other assets
|
| |
943
|
| |
2,920
|
| |
(421)
|
| |
A
|
| |
3,442
|
|
Total current assets
|
| |
51,430
|
| |
10,717
|
| |
—
|
| |
|
| |
61,726
|
|
Property and equipment, net
|
| |
273
|
| |
1,147
|
| |
—
|
| |
|
| |
1,420
|
|
Right-of-use assets, net
|
| |
152
|
| |
7,350
|
| |
—
|
| |
|
| |
7,502
|
|
Restricted cash, noncurrent
|
| |
—
|
| |
618
|
| |
—
|
| |
|
| |
618
|
|
Investments in related parties
|
| |
874
|
| |
—
|
| |
—
|
| |
|
| |
874
|
|
Other long-term prepaid assets
|
| |
61
|
| |
2,832
|
| |
—
|
| |
|
| |
2,893
|
|
TOTAL ASSETS
|
| |
$52,790
|
| |
$22,664
|
| |
$(421)
|
| |
|
| |
$75,033
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS'
EQUITY (DEFICIT)
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Current liabilities:
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Accounts payable
|
| |
$2,720
|
| |
$2,805
|
| |
$—
|
| |
|
| |
$5,525
|
|
Accrued expenses
|
| |
2,569
|
| |
1,935
|
| |
1,600
|
| |
A
|
| |
12,776
|
|
|
| |
|
| |
|
| |
3,184
|
| |
B
|
| |
|
|
|
| |
|
| |
|
| |
3,488
|
| |
D
|
| |
|
|
Deferred research obligation
|
| |
—
|
| |
1,436
|
| |
—
|
| |
|
| |
1,436
|
|
Operating lease liability, current
|
| |
994
|
| |
692
|
| |
—
|
| |
|
| |
1,686
|
|
Financing obligation, current
|
| |
67
|
| |
—
|
| |
—
|
| |
|
| |
67
|
|
Warrant liability
|
| |
19
|
| |
—
|
| |
—
|
| |
|
| |
19
|
|
Total current liabilities
|
| |
6,369
|
| |
6,868
|
| |
8,272
|
| |
|
| |
21,509
|
|
Operating lease liability, noncurrent
|
| |
2,481
|
| |
6,789
|
| |
—
|
| |
|
| |
9,270
|
|
Unvested option exercise liability
|
| |
—
|
| |
92
|
| |
—
|
| |
|
| |
92
|
|
Financing obligation, noncurrent
|
| |
168
|
| |
—
|
| |
—
|
| |
|
| |
168
|
|
Total liabilities
|
| |
9,018
|
| |
13,749
|
| |
8,272
|
| |
|
| |
31,039
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
COMMITMENTS AND CONTINGENCIES
|
| |
—
|
| |
—
|
| |
—
|
| |
|
| |
—
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Convertible Preferred Stock:
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Series C
|
| |
—
|
| |
40,621
|
| |
(40,621)
|
| |
E
|
| |
—
|
|
Series B
|
| |
—
|
| |
62,944
|
| |
(62,944)
|
| |
E
|
| |
—
|
|
Series A
|
| |
—
|
| |
7,495
|
| |
(7,495)
|
| |
E
|
| |
—
|
|
|
| |
—
|
| |
111,060
|
| |
(111,060)
|
| |
|
| |
—
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Stockholders' Equity (Deficit)
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Common stock
|
| |
301
|
| |
177
|
| |
2,761
|
| |
E
|
| |
352
|
|
|
| |
|
| |
|
| |
(301)
|
| |
G
|
| |
|
|
|
| |
|
| |
|
| |
(2,586)
|
| |
F
|
| |
|
|
Additional paid-in capital
|
| |
297,327
|
| |
4,686
|
| |
(153,078)
|
| |
H
|
| |
|
|
|
| |
|
| |
|
| |
2,586
|
| |
F
|
| |
151,521
|
|
Accumulated other comprehensive income
|
| |
86
|
| |
—
|
| |
(86)
|
| |
G
|
| |
—
|
|
Accumulated deficit
|
| |
(253,942)
|
| |
(107,008)
|
| |
253,071
|
| |
I
|
| |
(107,879)
|
|
Total stockholders' equity (deficit)
|
| |
43,772
|
| |
(102,145)
|
| |
102,367
|
| |
|
| |
43,994
|
|
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
| |
$52,790
|
| |
$22,664
|
| |
$(421)
|
| |
|
| |
$75,033
|
PF-3
Unaudited Pro Forma Condensed Combined Statements of Operations
For the Year Ended December 31, 2022
(In thousands, except share and per share amounts)
|
|
| |
For the Year Ended December 31, 2022
|
| |
|
| |
|
| |
|
| |
|
| |
|
|||
|
|
| |
Angion
Biomedica
Corp.
(Historical)
|
| |
Elicio
Therapeutics,
Inc. and
Subsidiary
(Historical)
|
| |
Transaction
Accounting
Adjustments
|
| |
Notes
|
| |
Other
Transaction
Accounting
Adjustments
|
| |
Notes
|
| |
Pro Forma
Combined
|
|
Revenue
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Contract revenue
|
| |
$2,301
|
| |
$—
|
| |
$—
|
| |
|
| |
$—
|
| |
|
| |
$2,301
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Operating expenses:
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Research and development
|
| |
18,100
|
| |
18,103
|
| |
|
| |
|
| |
—
|
| |
|
| |
36,203
|
|
General and administrative
|
| |
14,637
|
| |
5,630
|
| |
3,184
|
| |
B
|
| |
88
|
| |
L
|
| |
27,810
|
|
|
| |
|
| |
|
| |
783
|
| |
C
|
| |
|
| |
|
| |
|
|
|
| |
|
| |
|
| |
3,488
|
| |
D
|
| |
|
| |
|
| |
|
|
Restructuring expenses
|
| |
9,185
|
| |
—
|
| |
—
|
| |
|
| | | |
|
| |
9,185
|
|
|
Total operating expenses
|
| |
41,922
|
| |
23,733
|
| |
7,455
|
| |
|
| |
88
|
| |
|
| |
73,198
|
|
Loss from operations
|
| |
(39,621)
|
| |
(23,733)
|
| |
(7,455)
|
| |
|
| |
(88)
|
| |
|
| |
(70,897)
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Other income (expense):
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Change in the fair value of embedded derivative
|
| |
—
|
| |
(945)
|
| |
—
|
| |
|
| |
945
|
| |
J
|
| |
—
|
|
Change in fair value of warrant liability
|
| |
95
|
| |
—
|
| |
—
|
| |
|
| |
—
|
| |
|
| |
95
|
|
Foreign exchange transaction loss
|
| |
(237)
|
| |
—
|
| |
—
|
| |
|
| |
—
|
| |
|
| |
(237)
|
|
Gain upon debt extinguishment
|
| |
—
|
| |
2
|
| |
—
|
| |
|
| |
—
|
| |
|
| |
2
|
|
Gain in equity method investment
|
| |
151
|
| |
—
|
| |
—
|
| |
|
| |
—
|
| |
|
| |
151
|
|
Interest income
|
| |
805
|
| |
65
|
| |
—
|
| |
|
| |
—
|
| |
|
| |
870
|
|
Interest expense
|
| |
—
|
| |
(3,596)
|
| |
—
|
| |
|
| |
3,596
|
| |
K
|
| |
—
|
|
Total other income (expense), net
|
| |
814
|
| |
(4,474)
|
| |
—
|
| | | |
4,541
|
| | | |
881
|
||
|
Net loss
|
| |
(38,807)
|
| |
(28,208)
|
| |
(7,455)
|
| |
|
| |
4,453
|
| |
|
| |
(70,016)
|
|
Other comprehensive loss:
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Foreign currency translation adjustment
|
| |
189
|
| |
—
|
| |
—
|
| |
|
| |
—
|
| |
|
| |
189
|
|
Comprehensive loss
|
| |
$(38,618)
|
| |
$(28,208)
|
| |
$(7,455)
|
| |
|
| |
$4,453
|
| |
|
| |
$(69,827)
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
Net loss per share, basic and diluted
|
| |
$(1.29)
|
| |
$(1.62)
|
| |
N/A
|
| |
|
| |
N/A
|
| |
M
|
| |
$(2.01)
|
|
Weighted-average shares of common stock outstanding, basic
and diluted
|
| |
30,040,703
|
| |
17,458,461
|
| |
N/A
|
| |
|
| |
(12,643,403)
|
| |
|
| |
34,855,761
|
PF-4
NOTES TO THE UNAUDITED PRO FORMA CONDENSED
COMBINED FINANCIAL STATEMENTS
1. Description of the Transaction
Angion, Elicio, and Merger Sub have entered into the Merger
Agreement, pursuant to which Merger Sub will merge with and into Elicio, with Elicio surviving as the surviving company. As a result of the Merger, Elicio will be a wholly owned subsidiary of Angion. Upon the Effective Time, all shares of
Elicio capital stock outstanding immediately prior to the Effective Time, and after giving effect to the preferred stock conversion, and excluding any shares held in treasury stock by Elicio or owned by Angion or any subsidiary of Angion or
Elicio and any dissenting shares, will be converted into the right to receive approximately 5,719,223 shares of Angion common stock in the aggregate on a fully diluted basis, based on an assumed Exchange Ratio of 0.0164 (which assumes a reverse
stock split of Angion common stock at a ratio of 10-for-1 to be implemented prior to the consummation of the Merger, as may be adjusted) which is subject to certain adjustments, including based on the final determination of Angion Net Cash at
Closing, and to account for the effect of a reverse stock split. This Exchange Ratio is an estimate only and the final Exchange Ratio will be determined pursuant to a formula described in more detail in the Merger Agreement. Angion will assume
outstanding and unexercised stock options, and warrants to purchase shares of Elicio capital stock, and in connection with the Merger they will be converted into options and warrants to purchase shares of Angion common stock based on the final
Exchange Ratio.
Immediately following the Effective Time of the Merger, Elicio’s
equity holders are expected to own or hold rights to acquire 65.5% of the combined company and Angion’s equity holders are expected to own or hold rights to acquire 34.5% of the combined company, in each case, on a fully-diluted basis subject
to certain assumptions, including, but not limited to, Angion’s Net Cash as of the Closing of the Merger between $26.5 million and $31.5 million.
Consummation of the Merger is subject to certain closing
conditions, including, among other things, approval by the Angion and Elicio stockholders.
2. Basis of Pro Forma Presentation
The unaudited pro forma condensed combined financial information
has been prepared in accordance with SEC Regulation S-X Article 11, as amended. The unaudited pro forma condensed combined statements of operations for the year ended December 31, 2022, give effect to the Merger as if it had been consummated on
January 1, 2022.
The unaudited pro forma condensed combined balance sheet as of
December 31, 2022 gives effect to the Merger and combines the historical balance sheets of Angion and Elicio as of such date. Based on Elicio’s preliminary review of Elicio’s and Angion’s summary of significant accounting policies and
preliminary discussions between management teams of Elicio and Angion, the nature and amount of any adjustments to the historical financial statements of Angion to conform its accounting policies to those of Elicio are not expected to be
material. Upon completion of the Merger, further review of Angion’s accounting policies may result in additional revisions to Angion’s accounting policies and classifications to conform to those of Elicio.
For purposes of these unaudited pro forma condensed combined
financial statements, the estimated purchase price consideration consists of the following:
|
|
| |
Amount
|
|
Estimated number of shares of the combined company to be
owned by Angion's stockholders(i)
|
| |
30,113,946
|
|
Multiplied by the estimated fair value per share of Angion's common stock(ii)
|
| |
$0.5200
|
|
Total (in thousands)
|
| |
$15,659
|
|
Estimated fair value of assumed Angion equity awards based
on pre-combination service (in thousands)(iii)
|
| |
1,436
|
|
Total estimated purchase price consideration (in thousands)
|
| |
$17,095
|
|
(i)
|
Reflects the number of shares of common stock of the combined company that Angion equity holders are expected to own as of the
Effective Time pursuant to the Merger Agreement. This amount is calculated, for purposes of this unaudited pro forma condensed combined financial information, based on shares of Angion common stock outstanding at December 31, 2022, and
contemplation of equity instruments that are in-the-money and expected to be net exercised using the treasury stock method.
|
PF-5
|
(ii)
|
Reflects the price per share of Angion common stock, which is the closing bid price of Angion common stock as reported by
Nasdaq on March 22, 2023.
|
|
(iii)
|
Reflects the estimated acquisition-date fair value of the assumed Angion equity awards attributable to pre-merger service
expected to be outstanding as of the Effective Time.
|
The actual purchase price consideration transferred for the net
assets of Angion will vary based on, among other things, the net cash calculation prior to closing, the Exchange Ratio, and the Angion share price at closing, and that difference could be material. As such, the estimated purchase price
consideration reflected in these unaudited pro forma condensed combined financial information does not purport to represent what the actual purchase price consideration will be when the Merger is completed. The actual purchase price will
fluctuate until the Effective Time of the Merger, and the final valuation of the purchase price consideration could differ significantly from the current estimate.
For accounting purposes, Elicio is considered to be the acquiring
company and the Merger is expected to be accounted for as a reverse recapitalization of Angion by Elicio because on the Merger date, the pre-combination assets of Angion are expected to be primarily cash, and other non-operating assets.
Under reverse recapitalization accounting, the assets and
liabilities of Angion will be recorded, as of the completion of the Merger, at their fair value, which is expected to approximate the carrying value of the pre-Merger assets. Any difference between the final fair value of the consideration
transferred and the fair value of the net assets of Angion following determination of the actual purchase price consideration for Angion will be reflected as an adjustment to additional paid-in capital. As a result, any change in fair value of
the consideration transferred is not expected to materially affect the unaudited pro forma condensed combined financial information. The subsequent financial statements of Elicio will reflect the combined operations of Elicio as the acquirer
for accounting purposes together with a deemed issuance of shares, equivalent to the shares held by the stockholders of the legal acquirer, Angion, immediately prior to the Effective Time, and a recapitalization of the equity of the accounting
acquirer, Elicio.
The accompanying unaudited proforma condensed combined financial
information is derived from the historical financial statements of Angion and Elicio, and include adjustments to give pro forma effect to reflect the accounting for the Merger in accordance with GAAP. The historical financial statements of
Elicio shall become the historical financial statements of the combined company.
Elicio and Angion may incur significant costs associated with
integrating the operations of Elicio and Angion after the Merger is completed. The unaudited pro forma condensed combined financial information does not reflect the costs of any integration activities or benefits that may result from
realization of future cost savings from operating efficiencies expected to result from the Merger.
The unaudited pro forma condensed combined financial information
may differ from the final purchase accounting for a number of reasons, including the fact that the estimate of the fair value of Angion’s net assets at the closing date is preliminary and subject to change up to the closing date. The
differences that may occur between the preliminary estimate and the final purchase accounting could have a material impact on the accompanying unaudited pro forma condensed combined financial information.
PF-6
3. Shares of Angion Common Stock Issued to Elicio Stockholders upon
Closing of the Merger
Prior to the Merger, all outstanding shares of Elicio preferred
stock are expected to be converted or exercised into, as applicable, Elicio common stock, which will be exchanged for shares of Angion common stock based on the Exchange Ratio determined in accordance with the Merger Agreement. The assumed
Exchange Ratio for purposes of the unaudited pro forma condensed combined financial information of 0.0164 was derived on a fully-diluted basis as of January 17, 2023, assuming a reverse stock split of Angion common stock at a ratio of 10-for-1
to be implemented prior to the consummation of the Merger, as may be adjusted, and using a negotiated fixed valuation of Elicio of $95 million and an Angion valuation of $50.1 million, which is subject to the adjustment based upon Angion Net
Cash. The estimated number of shares of common stock that Angion expects to issue to Elicio’s stockholders (ignoring rounding of fractional shares) assumes Angion’s net cash at closing of the Merger is between $26.5 million and $31.5 million is
determined as follows:
|
Shares of Elicio Common Stock outstanding at December 31, 2022
|
| |
17,699,327
|
|
Shares of Elicio Series A, B, C-1, and C-2 Preferred
Shares outstanding at December 31, 2022 on an as-converted basis
|
| |
276,142,623
|
|
|
| |
293,841,950
|
|
Exchange Ratio
|
| |
0.01640
|
|
Estimated shares of Angion common stock expected to be issued to Elicio upon
closing
|
| |
4,819,008
|
4. Adjustments to Unaudited Pro Forma Condensed Combined Financial
Statements
Adjustments included in the column under the heading “Transaction
Accounting Adjustments” reflect the application of the required accounting to the Merger, applying the effects of the Merger to Elicio’s and Angion’s historical financial information. Adjustments included in the column under the heading “Other
Transaction Accounting Adjustments” are primarily related to other transactions that are material to the reader of the pro forma financial statements but not part of the required accounting directly related to the Merger. Further analysis will
be performed after the completion of the Merger to confirm these estimates or make adjustments in the final purchase price allocation, as necessary.
Given Elicio’s history of net losses and full valuation
allowances, management assumed a statutory tax rate of 0%. Therefore, the pro forma adjustments to the unaudited pro forma condensed combined statements of operations resulted in no additional income tax adjustment to the unaudited pro forma
financials.
The unaudited pro forma adjustments included in the unaudited pro
forma condensed combined financial information are as follows:
Transaction Accounting Adjustments:
|
A.
|
To reflect preliminary estimated transaction costs of $1.6 million, not yet reflected in the historical financial statements,
that are expected to be incurred by Elicio in connection with the Merger, such as legal fees, accounting expenses and consulting fees, as an increase in accrued expenses, and the reclassification of $421 thousand of transactions costs
recorded in prepaid expenses and other assets, and a reduction to additional paid-in capital in the unaudited pro forma condensed combined balance sheet. As the Merger will be accounted for as a reverse recapitalization equivalent to
the issuance of equity for the net assets, primarily cash, of Angion, these direct and incremental costs are treated as a reduction of the net proceeds received within additional paid-in capital.
|
|
B.
|
To reflect preliminary estimated transaction costs of $3.2 million, not yet reflected in the historical financial statements,
which are expected to be incurred by Angion in connection with the Merger, such as adviser and legal fees, as an increase in accrued expenses and accumulated deficit in the unaudited pro forma condensed combined balance sheet.
|
|
C.
|
To reflect (1) $1.4 million of consideration transferred related to the pre-merger service of replacement awards, in Note G,
and (2) the one-time post-merger stock-based compensation expense of $783 thousand, in Note H, as an increase in additional paid-in capital and accumulated deficit, and the unaudited pro forma condensed combined statement of operations
for the year ended December 31, 2022, reflected as general and administrative expense, related to the modification of certain awards extending the exercise period from 3 months to 4 years.
|
PF-7
|
D.
|
To reflect the one-time severance expense of $3.5 million in General and Administrative expenses and accrued expenses to be
paid in connection with the closing of the Merger in accordance with Angion’s retention bonus plan.
|
|
E.
|
Reclassification of $108.3 million to Additional Paid-in Capital “APIC”, representing $111.1 million of preferred stock, and
$2.8 million of par value to common stock, reflecting the conversion of 240,132,083 shares of Elicio Series A, B, C-1, and C-2 Preferred Stock into 276,142,623 shares of Elicio common stock prior to the Merger to be exchanged for
4,528,739 shares of Angion common stock at an assumed exchange ratio of 0.0164. The par value of Elicio and Angion common stock is $0.01 while the par value of Elicio preferred stock is $0.001, which has been reflected as an increase to
the par value of common stock.
|
|
F.
|
Reclassification of $2.6 million from common stock to APIC related to Elicio’s common shares outstanding as of December 31,
2022, that convert into Angion common stock at an assumed exchange ratio of 0.0164.
|
|
G.
|
To reflect the elimination of Angion’s historical net equity, which represents the net assets acquired in the reverse
recapitalization:
|
|
|
| |
Amount
(in Thousands)
|
|
Pre-merger stock-based compensation expense (Note C)
|
| |
$(1,436)
|
|
Historical Angion additional paid-in capital
|
| |
(297,327)
|
|
Total pre-merger Angion additional paid-in capital
|
| |
(298,763)
|
|
Pre-merger Angion accumulated deficit:
|
| |
|
|
Historical Angion accumulated deficit
|
| |
253,942
|
|
Angion transaction costs (Note B)
|
| |
3,184
|
|
Severance expenses related to Angion's retention bonus plan (Note D)
|
| |
3,488
|
|
Total pre-merger Angion's accumulated deficit
|
| |
260,614
|
|
Angion common stock
|
| |
(301)
|
|
Angion accumulated other comprehensive income
|
| |
(86)
|
|
Total adjustment to historical equity (net assets of Angion)
|
| |
$(38,536)
|
|
H.
|
The pro forma adjustments recorded in additional paid-in capital as noted include:
|
|
|
| |
Amount
(in Thousands)
|
|
Elimination of pre-merger Angion additional paid-in capital (Note G)
|
| |
$(298,763)
|
|
Record purchase of Angion historical net assets (Note G)
|
| |
38,536
|
|
Expected transaction costs of Elicio (Note A)
|
| |
(2,021)
|
|
Conversion of historical Elicio preferred stock issued at
December 31, 2022, and the conversion into Angion Common Stock (Note E)
|
| |
108,299
|
|
Recognition of Angion’s accelerated post-merger stock compensation (Note C)
|
| |
783
|
|
Recognition of Elicio's accelerated RSU's (Note L)
|
| |
88
|
|
Total adjustments to additional paid-in capital
|
| |
$(153,078)
|
|
I.
|
The pro forma adjustments recorded to accumulated deficit as noted include:
|
|
|
| |
Amount
(in Thousands)
|
|
Elimination of historical Angion accumulated deficit (Note G)
|
| |
$253,942
|
|
Recognition of Angion's accelerated post-merger stock compensation (Note C)
|
| |
(783)
|
|
Acceleration of RSU's by Elicio (Note L)
|
| |
(88)
|
|
Total adjustment to accumulated deficit
|
| |
$253,071
|
PF-8
Other Transaction Accounting Adjustments:
|
J.
|
Elimination of $945 thousand recorded in change in the fair value of embedded derivative for the twelve-months ended
December 31, 2022, as these instruments were recorded at fair value, and subsequently adjusted to their fair value with changes reflected in earnings and were related to Elicio’s convertible notes that were redeemed.
|
|
K.
|
Elimination of $3.6 million of interest expense for the twelve months ended December 31, 2022, all of which are related to
the convertible notes that were redeemed.
|
|
L.
|
To reflect the one-time stock compensation expense of $88 thousand in general and administrative expense related to the
acceleration of restricted stock units pursuant to a preexisting Elicio employment agreement for one of its executives which provides for such acceleration upon a change in control provision, which will be triggered by the Merger.
|
|
M.
|
The pro forma basic and diluted earnings per share have been adjusted to reflect the pro forma net loss for the year ended
December 31, 2022. In addition, the number of shares used in calculating the pro forma combined basic and diluted net loss per share has been adjusted to reflect the estimated total number of shares of common stock of the combined
company for the respective periods. For the year ended December 31, 2022, the pro forma weighted average shares outstanding has been calculated as follows:
|
|
|
| |
December 31,
2022
|
|
Elicio weighted-average shares of common stock outstanding
|
| |
17,458,461
|
|
Impact of Elicio Series A, B, C-1, and C-2 preferred stock
assuming conversion as of January 1, 2022 on an as converted basis
|
| |
276,142,623
|
|
Total
|
| |
293,601,084
|
|
Application of the exchange ratio to historical Elicio weighted-average shares
outstanding
|
| |
0.0164
|
|
Adjusted Elicio weighted-average shares outstanding
|
| |
4,815,058
|
|
Historical Angion weighted-average shares of common stock outstanding
|
| |
30,040,703
|
|
Total pro forma weighted-average shares outstanding
|
| |
34,855,761
|
Concurrent with the consummation of the proposed merger, Angion
stockholders will approve a reverse stock split. Because the final reverse stock split ratio will not be known until such time, we are providing supplemental pro forma earnings per share disclosure based on the stockholder proposal of the
reverse stock split ratio ranging from 5-for-1 to 30-for-1. For purposes of calculating the incremental pro forma earnings per share disclosure, we have utilized a 10-for-1 reverse stock split as this was the basis for determine the disclosed
exchange ratio. Based on an assumed reverse stock split ratio of 10-for-1, the pro forma weighted-average shares outstanding would be 7,819,128, and the basic and diluted pro forma net loss per share would be $8.95 for the year ended
December 31, 2022.
PF-9
INDEX TO FINANCIALS
Index to Consolidated Financial Statements
|
|
| |
Page
|
|
Financial Statements for the Years Ended December 31, 2022
and 2021
|
| |
|
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | |
Index to Consolidated Financial Statements
|
|
| |
Page
|
|
Financial Statements for the Years Ended December 31, 2022
and 2021
|
| |
|
| | | ||
| | | ||
| | | ||
| | | ||
| | | ||
| | |
F-1
Angion Biomedica Corp.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of
Angion Biomedica Corp. (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders’ equity (deficit) and cash flows for the years then ended, and the related notes
(collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2022
and 2021, and the consolidated results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of
the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the
PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required
to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of
expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of
material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures to respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and
disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial
statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Moss Adams LLP
Seattle, Washington
March 17, 2023
We have served as the Company's auditor since 2018.
F-2
