0001214659-17-007458.txt : 20171227 0001214659-17-007458.hdr.sgml : 20171227 20171227163027 ACCESSION NUMBER: 0001214659-17-007458 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20171221 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Submission of Matters to a Vote of Security Holders ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20171227 DATE AS OF CHANGE: 20171227 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HUMANIGEN, INC CENTRAL INDEX KEY: 0001293310 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 770557236 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35798 FILM NUMBER: 171276390 BUSINESS ADDRESS: STREET 1: 1000 MARINA BOULEVARD STREET 2: SUITE 250 CITY: BRISBANE STATE: CA ZIP: 94005-1878 BUSINESS PHONE: 650.243.3100 MAIL ADDRESS: STREET 1: 1000 MARINA BOULEVARD STREET 2: SUITE 250 CITY: BRISBANE STATE: CA ZIP: 94005-1878 FORMER COMPANY: FORMER CONFORMED NAME: KALOBIOS PHARMACEUTICALS INC DATE OF NAME CHANGE: 20040609 8-K 1 f12261708k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of
 the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): December 21, 2017
 
Humanigen, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-35798
 
77-0557236
(State or other Jurisdiction of
 Incorporation)
  
(Commission File No.)
  
(IRS Employer Identification No.)
 
 
1000 Marina Boulevard, Suite 250
Brisbane, CA  94005-1878
 (Address of principal executive offices, including zip code)
 
(650) 243-3100
(Registrant’s telephone number, including area code)
 
(Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):
 
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
 
Emerging growth company ☒
 
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 13(a) of the Exchange Act. ☐
 
 
 
Introductory Note
 
As previously disclosed, on December 21, 2016, Humanigen, Inc. (the “Company”) entered into that certain Credit and Security Agreement, as amended on March 21, 2017 and on July 8, 2017 (as amended, the “Credit Agreement”), with Black Horse Capital Master Fund LTD (“BHCMF”), Black Horse Capital LP (“BHC”), Cheval Holdings, Ltd. (“Cheval” and collectively with BHCMF and BHC, the “Black Horse Entities”), and Nomis Bay LTD (“Nomis Bay” and, collectively with the Black Horse Entities, the “Lenders”). On December 1, 2017, the Company’s obligations matured under the Credit Agreement. As of December 21, 2017, the aggregate amount of the Company’s obligations under the Credit Agreement, including accrued interest and fees, approximated $16.3 million (the “Term Loans”).
  
As previously disclosed, because the Company did not have access to sufficient funds to repay the Term Loans that have matured and was in default under the Credit Agreement due to its failure to repay such outstanding obligations, the Company had been discussing with its Lenders alternative transactions to satisfy the Company’s obligations under the Term Loans. As further described below, on December 21, 2017, the Company reached an agreement, unanimously approved by the Company’s board of directors (the “Board”), with the Lenders on a series of transactions providing for, among other things, the conversion of the Term Loans into common stock of the Company, par value $0.001 (the “Common Stock”), in satisfaction and extinguishment of the outstanding obligations under the Credit Agreement and the cancellation of the Term Loans.
   
Item 1.01.          Entry into a Material Definitive Agreement.
 
On December 21, 2017, the Company entered into a Securities Purchase and Loan Satisfaction Agreement (the “Purchase Agreement”) and a Forbearance and Loan Modification Agreement (the “Forbearance Agreement” and, together with the Purchase Agreement, the “Agreements”), each with the Lenders. The Agreements provide for a series of transactions (the “Transactions”) pursuant to which, at the closing of the Transactions (the “Transaction Closing”), the Company will: (i) in exchange for the satisfaction and extinguishment of the entire balance of the Term Loans, (a) issue to the Lenders an aggregate of 59,786,848 shares of Common Stock (the “New Lender Shares”), and  (b) transfer and assign to an affiliate of Nomis Bay (the “JV Entity”), all of the assets of the Company related to benznidazole (the “Benz Assets”), the Company’s former drug candidate; and (ii) issue to Cheval an aggregate of 32,028,669 shares of Common Stock (the “New Black Horse Shares” and, collectively with the New Lender Shares, the “New Common Shares”) for total consideration of $3,000,000, providing new capital to enable the Company to pursue its new business strategy focused on developing its proprietary monoclonal antibodies for immunotherapy and oncology treatments.
 
Issuance of the New Lender Shares
 
Under the Purchase Agreement, at the Transaction Closing, the Company will issue to the Lenders the New Lender Shares, of which 29,893,424 shares of Common Stock will be issued to the Black Horse Entities and 29,893,424 shares of Common Stock will be issued to Nomis Bay. The issuance of the New Lender Shares to the Lenders and the assignment of the Benz Assets to the JV Entity will result in the satisfaction and extinguishment of the Company’s outstanding obligations under the Credit Agreement and the cancellation of the Term Loans, other than the Bridge Loan described below. At the Transaction Closing, the Company will no longer be liable for repayment of its outstanding obligations under the Credit Agreement, and all security interests of the Lenders in the Company’s assets will be released.
 
Transfer of the Benz Assets; Claims Advances
   
Under the Purchase Agreement, at the Transaction Closing, the Company will transfer and assign the Benz Assets to the JV Entity. The Company also will agree to retain, but provide the JV Entity the benefits of, any Benz Assets which are not permitted to be assigned absent receipt of third-party consents. The JV Entity (at the election of Nomis Bay, which will control the JV Entity) will have 90 days from the date of the Rule 2004 Discovery Order granting the Rule 2004 Discovery Motion (each as defined below), or 180 days from the Transaction Closing if a Rule 2004 Discovery Order is either entered denying the Rule 2004 Discovery Motion or has not been entered on or before the Transaction Closing, to decide, in its sole discretion, whether to elect to keep the Benz Assets (a “Positive Election”). The Benz Assets will revert back to the Company in the event that the JV Entity (at the election of Nomis Bay) elects not to make a Positive Election.
   
 
In connection with the transfer of the Benz Assets to the JV Entity, Nomis Bay will pay certain amounts incurred by the Company and the JV Entity after December 21, 2017 in investigating certain causes of action and claims related to or in connection with the Benz Assets (the “Claims”), including the right to pursue causes of action and claims related to potential misappropriation of the Company’s trade secrets by a competitor in connection with such competitor’s submissions to the U.S. Food and Drug Administration.  In addition, if the JV Entity (at the election of Nomis Bay) makes a Positive Election: (i) Nomis Bay will assume certain legal fees and expenses owed by the Company to its litigation counsel, and (ii) the Company will be entitled to receive 30% of any amounts realized from the successful prosecution of the Claims or otherwise from the Benz Assets, after Nomis Bay is reimbursed for certain expenses in connection with funding the Claims and after giving effect to any payments that the JV Entity may be required to make to any third parties.
 
Nomis Bay will have full control, in its sole discretion, over the management of the JV Entity, any development of or realization on the Benz Assets and the prosecution of the Claims. In addition, the Company has agreed that, as soon as practicable after entering into the Agreements, the Company will make appropriate motion to the Bankruptcy Court currently responsible for the Company’s pending Chapter 11 proceeding dating from December 2015 (the “Bankruptcy Court”) to permit discovery in relation to the Claims pursuant to Rule 2004 of the Federal Rules of Bankruptcy Procedure (the “Rule 2004 Discovery Motion”), and commence such discovery promptly after entry of an order of the Bankruptcy Court authorizing such discovery (the “Rule 2004 Discovery Order”). Nomis Bay has agreed to fund these litigation efforts from the date of the Agreements to the Transaction Closing or termination of the Transactions as secured loans under the Credit Agreement (“Claims Advances”). Pursuant to the Forbearance Agreement, the Claims Advances will have priority over the Bridge Loan (as defined below) and all other Term Loans in the Benz Assets. At the Transaction Closing, the entire amount of the Claims Advances will be deemed satisfied and extinguished along with the other Term Loans, and all security interests of Nomis Bay in the Benz Assets will be released.
 
Issuance of the New Black Horse Shares; Bridge Loan
 
Under the Purchase Agreement, at the Transaction Closing, the Company will also issue to Cheval the New Black Horse Shares for total consideration of $3,000,000 (including extinguishment of the Bridge Loan described below). The Company plans to use the proceeds from the issuance of the New Black Horse Shares for working capital and other costs incurred in the ordinary course of business, including additional fundraising.
 
On December 21, 2017, concurrently with entering into the Agreements, Cheval agreed to make a bridge loan to the Company of $1,500,000 (the “Bridge Loan”). Pursuant to the Forbearance Agreement, until the Transaction Closing, the Bridge Loan will be treated as a secured loan under the Credit Agreement. The Bridge Loan will have priority over the Claims Advances and the Term Loans in certain of the Company’s non-benznidazole related assets, including lenzilumab and ifabotuzumab. At the Transaction Closing, the entire amount of the Bridge Loan will be credited to Cheval’s $3,000,000 payment obligation and will be converted into New Black Horse Shares and all security interests of Cheval in the non-benznidazole assets will be released.
 
Additional Information
 
The Transaction Closing is subject to various conditions, including, among other things:  (i) there be no motion pending for, nor shall there have occurred (a) the appointment of a Chapter 11 Trustee for the Company, (b) the conversion of the Company’s pending bankruptcy case to a Chapter 7 case, (c) the filing of any additional or subsequent bankruptcy proceeding, or (d) the pursuit of an action under state law for the appointment of a receiver, assignee for the benefit of creditors, or a dissolution or reorganization; (ii) there not having occurred certain other events of default under the Credit Agreement; (iii) the Company’s delivery of certain transaction documents, including a bill of sale and assignment and assumption agreement and an operating agreement in connection with the JV Entity; (iv) the Charter Amendment becoming effective upon filing with the Delaware Secretary of State; (v) a hearing having occurred with the Bankruptcy Court in respect of the Rule 2004 Discovery Motion on or before March 15, 2018; (vi) Cheval having paid the purchase price for the New Black Horse Shares, and the Company’s delivery of the New Common Shares; and (vii) the parties’ execution and delivery of that certain termination and release agreement providing for, among other things, the termination of the Credit Agreement. The Transaction Closing will occur on the first business day following the satisfaction or waiver of the closing conditions discussed above and contained in the Agreements. If, on March 31, 2018, any of the closing conditions have not been satisfied or waived, then the Purchase Agreement will automatically terminate pursuant to its terms, unless extended by the Company and the Lenders.
  
 
If the parties complete the Transactions, the issuance of the New Common Shares to the Black Horse Entities at the Transaction Closing will result in a change of control of the Company, as the Black Horse Entities and their affiliates will own more than a majority of the Company’s outstanding Common Stock.
 
As of December 21, 2017, Nomis Bay held 3,680,106 shares of the Company’s Common Stock, or approximately 24.6% of the Company’s outstanding Common Stock. In addition, as of December 21, 2017, the aggregate amount of the Company’s obligations under the Credit Agreement owed to Nomis Bay, including accrued interest and fees, approximated $8.15 million.
 
As of December 21, 2017, the Black Horse Entities collectively held 4,948,758 shares of the Company’s Common Stock, or approximately 33.1% of the Company’s outstanding Common Stock. In addition, as of December 21, 2017, the aggregate amount of the Company’s obligations under the Credit Agreement owed to the Black Horse Entities, including accrued interest and fees, approximated $8.15 million. Dale Chappell, a former director of the Company who resigned on November 9, 2017, is an affiliate of each of the Black Horse Entities.
 
Item 2.03.          Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
 
The information called for by this item is contained in Item 1.01, which is incorporated herein by reference in its entirety. Under the Forbearance Agreement, the Lenders have agreed to refrain from exercising their rights and remedies in connection with the Company’s current ongoing default under the Credit Agreement until the earlier of (i) the Transaction Closing, (ii) the termination of the Transactions in accordance with the terms of the Purchase Agreement, or (iii) March 31, 2018.
 
Item 3.02.          Unregistered Sales of Equity Securities.
 
The information called for by this item is contained in Item 1.01, which is incorporated herein by reference in its entirety. The issuances of the New Common Shares will be made in reliance on the exemptions from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, as transactions not involving a public offering and/or  Regulation D under the Securities Act as sales to accredited investors.
 
Item 5.07.          Submission of Matters to a Vote of Security Holders.
 
To enable the Company to complete the restructuring transaction described above, the Board unanimously approved and recommended, and on December 21, 2017, the Lenders, which, in their respective capacities as stockholders in the Company owned as of December 21, 2017 (the “Record Date”) an aggregate of 8,628,864 shares of the Company’s Common Stock, or approximately 58% of the Company's outstanding Common Stock as of the Record Date, approved by written consent in lieu of a special meeting, in accordance with applicable provisions of Delaware law and the Company’s governing documents, the approval of an amendment (the “Charter Amendment”) to Article IV of the Amended and Restated Certificate of Incorporation of the Company, as amended, to (i) increase the number of authorized shares of Common Stock from 85,000,000 to 225,000,000, and (ii) authorize the issuance of 25,000,000 shares of preferred stock of the Company, par value $0.001 (the “Preferred Stock”), with such powers, rights, terms and conditions as may be designated by the Board upon the issuance of shares of Preferred Stock at one or more times in the future. The Company will prepare and cause to be sent or delivered to its stockholders pursuant to Regulation 14C under the Securities Exchange Act of 1934 an information statement relating to the Charter Amendment, which will not become effective until the filing thereof with the Delaware Secretary of State.
 
  
Item 7.01.          Regulation FD Disclosure
 
On December 21, 2017, the Company issued a press release announcing that it had entered into the Agreements described above. The press release is attached as Exhibit 99.1 and is incorporated herein by reference.
 
Item 9.01.          Financial Statements and Exhibits.
 
(d)          Exhibits

Exhibit No.
  
Description
     
99.1
  
 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
           
 
HUMANIGEN, INC.
 
 
 
 
By:
/s/ Cameron Durrant
 
 
Name: Cameron Durrant
 Title:   Chairman of the Board and Chief Executive Officer
 
Dated: December 27, 2017
 
 
Exhibit Index
 
Exhibit No.
  
Description
     
99.1
  


EX-99.1 2 ex99_1.htm EXHIBIT 99.1
Exhibit 99.1
 
 
Humanigen Signs Definitive Agreements to Exchange Loan Obligations for Equity

Transactions Create Biotechnology Company Focused on Immunotherapy and Oncology

Lenzilumab Begins Development for Treating Key Side-Effects Associated with CAR-T


BRISBANE, Calif. – December 21, 2017 – Humanigen, Inc. (OTCQB: HGEN), a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for immunotherapy and oncology treatments, today announced it has entered into definitive agreements with its lenders to, among other things, exchange the entire balance of approximately $16.3 million in term loans for common stock of the company. The transactions are expected to close in the first quarter of 2018 subject to the satisfaction of certain conditions contained in the definitive agreements.

Humanigen will also receive a new $3 million investment from an affiliate of Black Horse Capital, one of the lenders, to fund the company and its transformational new strategy of developing the monoclonal antibodies lenzilumab and ifabotuzumab in the fast-growing and exciting areas of immunotherapy and oncology.

The company has begun work with leading key opinion leaders in the chimeric antigen receptor T-cell (CAR-T) therapy field to advance lenzilumab into phase 1 trials for the prevention of neurotoxicity associated with CAR-T therapy. Lenzilumab is an antagonist of circulating granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF is thought to be a potential key factor in neurotoxicity, and perhaps other side-effects, associated with CAR-T therapy.

By neutralizing circulating GM-CSF, and upon demonstrating meaningful effects on neurotoxicity without hampering the efficacy of CAR-T, lenzilumab has the potential to make CAR-T therapy:
·
safer by lessening neurotoxicity
·
more effective by allowing higher CAR-T doses, greater CAR-T expansion, and potentially reducing myeloid-derived suppressor cells (MDSC) that inhibit T cell function
·
a more routine out-patient procedure

Humanigen also continues to enroll patients in its phase 1 study of lenzilumab for the treatment of chronic myelomonocytic leukemia (CMML), a rare hematologic cancer, with interim data expected in the first half of 2018.

In addition, the other key asset in the Humanigen monoclonal antibody portfolio, ifabotuzumab, has been dosed in the first patient in an investigator-sponsored phase 0/1 radio-labeled imaging trial in glioblastoma multiforme (GBM), a particularly aggressive and deadly brain cancer. According to the investigators at the Olivia Newton-John Cancer Research Institute in Australia, the trial will seek to confirm the safety of ifabotuzumab and potentially determine the best dose to effectively penetrate brain tumors. The investigators expect 12 patients to participate in the trial, for which eligibility criteria are recurrent GBM and receipt of only one type of chemotherapy for disease recurrence. The company also is exploring partnering opportunities to enable further development of ifabotuzumab as a potential treatment for certain solid and hematologic cancers as an antibody-drug conjugate (ADC) and as a CAR-T construct.
 
1000 Marina Boulevard, Suite 250   |   Brisbane, CA 94005   |   Phone 650.243.3100   |   Fax 650.243.3260   |   www.humanigen.com
 
 
“This transaction resets Humanigen as a cutting-edge science immunotherapy and oncology biotechnology company,” said Cameron Durrant, MD, chairman and CEO. “By following the recent, exciting, ground-breaking science related to lenzilumab’s potential utility to help in CAR-T therapy, as well as a new clinical trial for ifabotuzumab, we are writing a new history for Humanigen driven by science to help patients with new medical innovations.”
 
At the transactions’ closing, the company will issue 59,786,848 new shares of common stock to the lenders in exchange for the satisfaction and extinguishment of the company’s obligations with respect to its outstanding secured loans. In addition, at closing, Humanigen will assign all of its assets and rights related to its former benznidazole drug candidate to a new entity formed and controlled by one of the lenders. As previously reported, these assets and rights are no longer relevant to the company’s forward-looking business plan as described above. And the company will issue 32,028,669 new shares of common stock to an affiliate of Black Horse Capital for $3 million, of which $1.5 million in new capital is expected to be received by the company on December 22, 2017 in the form of a secured loan that will be converted into common stock at the close. In total, these transactions provide $19.3 million of value to the company in return for the issuance of approximately 91.8 million shares of stock; common stock currently outstanding will represent 14% of the post-closing total outstanding shares.

The total number of new shares to be issued to affiliates of Black Horse Capital at the closing of these transactions, when combined with their existing ownership stakes, will result in Black Horse Capital and its affiliates owning more than 50% of the company’s outstanding shares of common stock.

About Humanigen

Humanigen, Inc. is a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for immunotherapy and oncology treatments.  Derived from the company’s Humaneered® platform, lenzilumab and ifabotuzumab are lead compounds in the portfolio of monoclonal antibodies with first-in-class mechanisms. Lenzilumab, which targets granulocyte-macrophage colony-stimulating factor (GM-CSF), is in development as a potential medicine to make chimeric antigen receptor T-cell (CAR-T) therapy safer and more effective, as well as a potential treatment for rare hematologic cancers such as chronic myelomonocytic leukemia (CMML) and juvenile myelomonocytic leukemia (JMML). Ifabotuzumab, which targets Ephrin type-A receptor 3 (EphA3), is being explored as a potential treatment for glioblastoma multiforme (GBM) and other deadly cancers. For more information, visit www.humanigen.com.

Forward-Looking Statements

This release contains forward-looking statements that are intended to be subject to protection afforded by the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the anticipated closing date of the transactions; our expectations regarding our ability to satisfy certain closing conditions, some of which are outside of our control; and our expectations for executing on the key priorities and anticipated milestones described above in regard to phase 1 trials of lenzilumab for the prevention of neurotoxicity associated with CAR-T and as a potential treatment of CMML, and the investigator-sponsored phase 0/1 radio-labeled imaging trial of ifabotuzumab as a potential treatment of GBM. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the failure to consummate the transactions due to unsatisfied closing conditions or otherwise; the risks inherent in Black Horse Capital and its affiliates owning more than 50% of our outstanding common stock upon closing, including their ability to control the company; the effect on our stock price of the significant dilution that will result from issuing common stock upon conversion of the term loan and the new capital investment as described above; our lack of profitability and the need for additional capital to operate our business as a going concern; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.
 
 
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.



CONTACT:

Investors:
Cameron Durrant
650-243-3181
cdurrant@humanigen.com

Mike Cole
O: 949-259-4988
C: 949-444-1341
mike.cole@mzgroup.us

Media:
media@humanigen.com
 
 
 
###
 
 
 
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