UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO |
Commission File Number
(Exact name of Registrant as specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) |
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Securities registered pursuant to Section 12(b) of the Act:
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The |
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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 13(a) of the Exchange Act. ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The number of shares of Registrant’s Common Stock outstanding as of May 9, 2023 was
Table of Contents
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1 |
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PART I |
3 |
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Item 1. |
3 |
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3 |
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4 |
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Condensed Consolidated Statements of Shareholders' Equity (Deficit) |
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6 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
7 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
20 |
Item 3. |
28 |
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Item 4. |
28 |
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PART II |
29 |
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Item 1. |
29 |
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Item 1A. |
29 |
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Item 2. |
31 |
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Item 3. |
31 |
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Item 4. |
31 |
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Item 5. |
31 |
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Item 6. |
32 |
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33 |
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i
EXPLANATORY NOTE
On December 16, 2022, Yumanity Therapeutics, Inc. (“Yumanity”) completed its previously announced merger transaction with Kineta Operating, Inc. (formerly Kineta, Inc.) (“Private Kineta”) in accordance with the terms of the Agreement and Plan of Merger, dated as of June 5, 2022, as amended on December 5, 2022 (the “Merger Agreement”), by and among Yumanity, Private Kineta and Yacht Merger Sub, Inc., a wholly-owned subsidiary of Yumanity (“Merger Sub”), pursuant to which Merger Sub merged with and into Private Kineta, with Private Kineta surviving such merger as a wholly-owned subsidiary of Yumanity (the “Merger”). The surviving corporation from the Merger subsequently merged with and into Kineta Operating, LLC, with Kineta Operating, LLC being the surviving corporation. On December 16, 2022, in connection with, and prior to the completion of, the Merger, Yumanity effected a 1-for-7 reverse stock split of its common stock. Immediately following the Merger, Yumanity changed its name to “Kineta, Inc.”
Unless the context otherwise requires, references to the “Company,” “Kineta,” the “combined organization,” “we,” “our” or “us” in this Quarterly Report on Form 10-Q refer to Private Kineta and its subsidiaries prior to completion of the Merger and to Kineta, Inc. and its subsidiaries after completion of the Merger. In addition, references to “Yumanity” refer to the registrant prior to the completion of the Merger.
The Merger has been accounted for as a reverse merger and asset acquisition in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Under this method of accounting, Private Kineta was deemed to be the accounting acquirer for financial reporting purposes. Following the Merger, the business conducted by Private Kineta became the Company’s primary business.
Except as otherwise noted, references to “common stock” in this report refer to common stock, $0.001 par value per share, of the Company.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains certain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. In some cases, you can identify these forward-looking statements by the use of terms such as “expect,” “will,” “continue,” “believe,” “estimate,” “aim,” “project,” “intend,” “should,” “is to be,” or similar expressions, and variations or negatives of these words, but the absence of these words does not mean that a statement is not forward-looking. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to differ materially from results expressed or implied in this Quarterly Report on Form 10-Q. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements:
1
The forward-looking statements contained in this Quarterly Report on Form 10-Q and the documents incorporated herein by reference are based on our current expectations and beliefs concerning future developments and their potential effects on our business. There can be no assurance that future developments affecting our business will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the caption “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q and under similar headings in the documents that are incorporated by reference herein. Moreover, we operate in a very competitive and rapidly changing environment.
New risks and uncertainties emerge from time to time and it is not possible for us to predict all such risk factors, nor can we assess the effect of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.
The forward-looking statements made by us in this Quarterly Report on Form 10-Q and the documents incorporated herein by reference speak only as of the date of such statement. Except to the extent required under the federal securities laws and rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”), we disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. In light of these risks and uncertainties, there is no assurance that the events or results suggested by the forward-looking statements will in fact occur, and you should not place undue reliance on these forward-looking statements.
Although we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law, you are advised to consult any additional disclosures we make in the documents that we file with the SEC.
2
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
KINETA, INC.
Condensed Consolidated Balance Sheets
(in thousands)
(Unaudited)
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March 31, |
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December 31, |
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2023 |
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2022 |
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Assets |
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Current assets: |
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Cash |
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$ |
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$ |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating right-of-use asset |
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Rights from Private Placement |
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Restricted cash |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity (Deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses and other current liabilities |
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Deferred revenue |
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Operating lease liability, current portion |
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Finance lease liabilities, current portion |
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Total current liabilities |
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Notes payable |
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Operating lease liability, net of current portion |
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Finance lease liabilities, net of current portion |
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Total liabilities |
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Stockholders’ equity (deficit): |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ equity (deficit) attributable to Kineta, Inc. |
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( |
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Noncontrolling interest |
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Total stockholders’ equity (deficit) |
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( |
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Total liabilities and stockholders’ equity (deficit) |
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$ |
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$ |
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See the accompanying notes to the unaudited condensed consolidated financial statements.
3
KINETA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Revenues: |
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Collaboration revenues |
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$ |
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$ |
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Licensing revenues |
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Grant revenues |
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Total revenues |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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Other (expense) income: |
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Interest expense (with related parties $ |
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( |
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( |
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Change in fair value measurement of notes payable |
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( |
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Gain on extinguishments of debt, net |
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Other (expense) income, net |
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( |
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Total other expense, net |
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Net loss |
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$ |
( |
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$ |
( |
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Net (loss) income attributable to noncontrolling interest |
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( |
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Net loss attributable to Kineta, Inc. |
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$ |
( |
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$ |
( |
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Net loss per share, basic and diluted |
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$ |
( |
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$ |
( |
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Weighted-average shares outstanding, basic and diluted |
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See the accompanying notes to the unaudited condensed consolidated financial statements.
4
KINETA, INC.
(in thousands)
(Unaudited)
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Common Stock |
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Additional Paid-In Capital |
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Accumulated |
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Total Stockholders’ Deficit Attributable |
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Noncontrolling |
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Total Stockholders’ |
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Shares |
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Amount |
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Amount |
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Deficit |
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to Kineta |
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Interest |
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Deficit |
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Balance as of December 31, 2021 |
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$ |
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$ |
( |
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$ |
( |
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$ |
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$ |
( |
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Issuance of common stock |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
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( |
) |
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( |
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Balance as of March 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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$ |
( |
) |
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Common Stock |
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Additional Paid-In Capital |
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Accumulated |
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Total Shareholders’ Equity (Deficit) Attributable |
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Noncontrolling |
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Total Shareholders’ |
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Shares |
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Amount |
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Amount |
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Deficit |
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to Kineta |
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Interest |
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Equity (Deficit) |
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Balance as of December 31, 2022 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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$ |
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Issuance of common stock |
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— |
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— |
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Issuance of common stock upon |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock for services |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Balance as of March 31, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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$ |
( |
) |
See the accompanying notes to the unaudited condensed consolidated financial statements.
5
KINETA, INC.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Operating activities: |
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Net loss |
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$ |
( |
) |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Change in fair value of notes payable |
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( |
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Non-cash stock-based compensation |
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Non-cash operating lease expense |
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Depreciation and amortization |
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Warrants issued for services |
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Gain on extinguishments of debt, net |
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( |
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Non-cash interest expense |
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Gain on disposal of asset |
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( |
) |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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( |
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Accounts payable |
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Accrued expenses and other current liabilities |
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( |
) |
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( |
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Operating lease liability |
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( |
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( |
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Deferred revenue |
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( |
) |
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( |
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Net cash used in operating activities |
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( |
) |
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( |
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Investing activities: |
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Purchases of property and equipment |
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( |
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Proceeds from sale of property and equipment |
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Net cash provided by (used in) investing activities |
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( |
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Financing activities: |
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Proceeds from notes payable |
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Proceeds from issuance of common stock |
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Proceeds from exercise of warrants |
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Repayments of notes payable |
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( |
) |
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Repayments of finance lease liabilities |
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( |
) |
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( |
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Net cash provided by (used in) financing activities |
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( |
) |
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Net change in cash and restricted cash |
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( |
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( |
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Cash and restricted cash at beginning of year |
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Cash and restricted cash at end of year |
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$ |
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$ |
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Components of cash and restricted cash: |
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Cash |
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$ |
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$ |
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Restricted cash |
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Total cash and restricted cash |
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$ |
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$ |
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Supplemental disclosure of cash flow information: |
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Cash paid for interest |
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$ |
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$ |
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See the accompanying notes to the unaudited condensed consolidated financial statements.
6
KINETA, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Description of Business
Kineta, Inc. (formerly Yumanity Therapeutics, Inc.) (together with its subsidiaries, the “Company”) is headquartered in Seattle, Washington.
The Company is a clinical-stage biotechnology company focused on developing new innovative therapies in the field of immuno-oncology and cancer. The Company also has drug programs in neurology (chronic pain) and an antiviral drug program in development for arenaviruses such as Lassa fever. Kineta Chronic Pain, LLC (“KCP”) was formed to develop new innovative therapies for pain management. Kineta Viral Hemorrhagic Fever, LLC (“KVHF”) was formed to develop a direct acting anti-viral therapy for the treatment of emerging diseases.
As of March 31, 2023 and December 31, 2022, the Company owns a majority interest of the outstanding issued equity of KCP and all of the outstanding issued equity of KVHF.
Private Placement
In connection and concurrently with the execution of the Merger Agreement, on June 5, 2022, the Company entered into a financing agreement, as amended on October 24, 2022, December 5, 2022, March 29, 2023 and May 1, 2023 (such financing agreement, as amended, the “Securities Purchase Agreement”), to sell shares of the Company’s common stock in a private placement (the “Private Placement”). The first closing of the Private Placement occurred on December 16, 2022, and the Company issued
Liquidity
The Company has incurred recurring net losses and negative cash flows from operations since inception and, as of March 31, 2023, had an accumulated deficit of $
The Company will need to raise additional capital to support its long-term plans and to complete clinical trials. The Company intends to raise additional debt and equity financings from its current investors as well as prospective investors and may receive milestone payments from its license agreements, or other sources. However, there is no guarantee that any of these additional financings or opportunities will be executed or realized on acceptable terms, if at all. The Company’s ability to raise additional capital through either the issuance of equity or debt is dependent on a number of factors including, but not limited to, Company prospects, which itself is subject to a number of development and business risks and uncertainties, as well as uncertainty about whether the Company would be able to raise such additional capital at a price or on terms that are acceptable.
Geopolitical Developments
Geopolitical developments, such as the Russian invasion of Ukraine or deterioration in the bilateral relationship between the United States and China, may impact government spending, international trade and market stability, and cause weaker macro-economic conditions. The impact of these developments, including any resulting sanctions, export controls or other restrictive actions that may be imposed against governmental or other entities in, for example, Russia, have in the past contributed and may in the future contribute to disruption, instability and volatility in the global markets, which in turn could adversely impact the Company’s operations and weaken the Company’s financial results. Certain political developments may also lead to uncertainty to regulations and rules that may materially affect the Company’s business.
Unaudited Interim Financial Information
The unaudited condensed consolidated balance sheet as of December 31, 2022 was derived from the Company’s audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America (“U.S. GAAP”). The accompanying unaudited condensed consolidated financial statements, as of March 31, 2023 and for the three months ended March 31, 2023, are unaudited and have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. The Company believes that the disclosures are adequate to make the information presented not misleading. There have been no changes to the Company’s significant accounting policies described in the Company’s Annual Report on Form 10-K
7
for the year ended December 31, 2022, filed with the SEC on March 31, 2023 (the “2022 Annual Report on Form 10-K”). These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2022 included in the 2022 Annual Report on Form 10-K. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of March 31, 2023 and condensed consolidated results of operations and cash flows for the three months ended March 31, 2023 and 2022 have been made. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.
Basis of Presentation and Consolidation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable SEC rules regarding annual financial reporting. The condensed consolidated financial statements include all accounts of the Company, its majority owned subsidiary KCP, and its wholly owned subsidiary, KVHF. All intercompany transactions and balances have been eliminated upon consolidation.
Noncontrolling interest in the accompanying condensed consolidated financial statements represents the proportionate share of equity which is not held by the Company. Net income (loss) of the non-wholly owned consolidated subsidiary is allocated to the Company and the holder(s) of the noncontrolling interests in proportion to their percentage ownership considering any preferences specific to the form of equity of the subsidiaries.
Revenue Recognition
Collaboration Revenues
In connection with the Merger, the Company became the successor in interest to an exclusive license and research collaboration agreement (the “Merck Collaboration Agreement”) with Merck & Co., Inc. to support research, development and commercialization of products for treatment of amyotrophic lateral sclerosis and frontotemporal lobar dementia. As of March 31, 2023, the Company had $
Accounting Pronouncements Recently Adopted
Effective January 1, 2023, the Company adopted Accounting Standards Update (“ASU”) 2020-08, “Codification Improvements to Subtopic 718-740, Compensation—Stock Compensation”. This ASU makes several improvements to the guidance in Subtopic 718-740, which addresses stock compensation. The adoption of ASU 2020-08 did not have a material impact on the consolidated financial statements.
The carrying amounts of the Company’s financial instruments, including cash, restricted cash, and accounts payable, approximate fair value due to the short-term nature of those instruments.
2022 & 2020 Notes Payable
The Company elected the fair value option to account for certain convertible notes payable and notes payable, referred to as the 2022 convertible notes, 2020 convertible notes and 2020 notes (see Note 5), respectively, and collectively the 2022 & 2020 notes payable. The 2020 convertible notes and 2020 notes are referred to as the 2020 notes payable. Upon the closing of the Merger in December 2022, the 2022 convertible notes and 2020 convertible notes were settled with shares of the Company’s common stock (see Note 5).
2020 Notes
The 2020 notes were valued using a discounted cash flow model based on the contractual payment dates, a discount rate and the contractual maturity date. The significant unobservable inputs used in the fair value measurement of the 2020 note for the three months ended March 31, 2023 were as follows: discount rate of
The significant unobservable inputs used in the fair value measurement of the 2020 notes for the three months ended March 31, 2022 were as follows: discount rate of
2020 Convertible Notes
8
The 2020 convertible notes were valued using a scenario-based analysis and a discounted cash flow model. Two primary scenarios were considered: the qualified financing scenario and the repayment scenario. The value of the 2020 convertible notes under each scenario was probability weighted to arrive at the estimated fair value for the notes. The qualified financing scenario considers the value impact of conversion at the stated discount to the
issue price if the Company completes a qualifying financing event before the maturity date. The repayment scenario considers payment of principal at the contractual maturity dates.
The significant unobservable inputs used in the fair value measurement of the 2020 convertible notes for the three months ended March 31, 2022 were as follows: discount rate of
2022 Convertible Notes
The 2022 convertible notes were valued using a scenario-based analysis and a discounted cash flow model. Two primary scenarios were considered: the qualified financing scenario and the automatic conversion scenario. The value of the 2022 convertible notes under each scenario was probability weighted to arrive at the estimated fair value for the notes. The qualified financing scenario considers the value impact of conversion at the stated discount to the issue price if the Company completes a qualifying financing event before the maturity date. The automatic conversion scenario estimates the timing of such conversion.
The significant unobservable inputs used in the fair value measurement of the 2020 notes for the three months ended March 31, 2022 were as follows: discount rate of
The following table provides a summary of the changes in the fair value of the Company’s 2022 & 2020 notes payable measured using Level 3 inputs:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
|
|
(in thousands) |
|
|||||
Balance at beginning of period |
|
$ |
|
|
$ |
|
||
Issuance of 2022 convertible notes |
|
|
|
|
|
|
||
Change in fair value of 2022 & 2020 notes payable |
|
|
|
|
|
( |
) |
|
Change in fair value of debt extinguishment |
|
|
|
|
|
( |
) |
|
Partial settlement of 2020 notes payable |
|
|
|
|
|
( |
) |
|
Balance at end of period |
|
$ |
|
|
$ |
|
Property and Equipment, Net
Property and equipment, net consisted of the following:
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
|
|
(in thousands) |
|
|||||
Laboratory equipment |
|
$ |
|
|
$ |
|
||
Computer and software |
|
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Total property and equipment |
|
|
|
|
|
|
||
Less: Accumulated depreciation and amortization |
|
|
|
|
|
|
||
Total property and equipment, net |
|
$ |
|
|
$ |
|
Depreciation and amortization expense was $
Rights from Private Placement
In connection and concurrently with the execution of the Merger Agreement, on June 5, 2022, the Company entered into a financing agreement, as amended on October 24, 2022, December 5, 2022, March 29, 2023 and May 1, 2023, to sell shares of the Company’s common stock in a private
9
placement (the “Private Placement”). The first closing of the Private Placement occurred on December 16, 2022, and the Company issued
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following as of the periods presented:
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
|
|
(in thousands) |
|
|||||
Compensation and benefits |
|
$ |
|
|
$ |
|
||
Professional services |
|
|
|
|
|
|
||
Accrued interest |
|
|
|
|
|
|
||
Accrued clinical trial and preclinical costs |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued expenses and other current liabilities |
|
$ |
|
|
$ |
|
Notes payable outstanding consisted of the following as of the periods presented:
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||||||||||
|
|
Principal |
|
|
Fair Value |
|
|
Principal |
|
|
Fair Value |
|
||||
|
|
(in thousands) |
|
|||||||||||||
Notes payable: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
2020 notes |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Other notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Small Business Administration loan |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total notes payable |
|
$ |
|
|
|
|
|
$ |
|
|
|
|
||||
Less: current portion |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Notes payable, net of current portion |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
The Company elected the fair value option for the 2020 notes (see Note 3). The other notes payable and Small Business Administration loan approximate their fair value because interest rates are at prevailing market rates.
Expected future minimum principal payments under the Company’s notes payables as of March 31, 2023 were as follows:
|
|
Total |
|
|
|
|
(in thousands) |
|
|
Years |
|
|
|
|
2023 |
|
$ |
|
|
2024 |
|
|
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
Thereafter |
|
|
|
|
Total notes payable |
|
$ |
|
|
Less: current portion |
|
|
|
|
Notes payable, net of current portion |
|
$ |
|
2020 Notes
In October 2020, the Company refinanced certain notes payable (the “2020 notes”), with an aggregate principal amount of $
10
the second quarter of 2023). The Company may repay the 2020 notes at any time without penalty. Upon bankruptcy the lender can accelerate all amounts due immediately.
In August 2022, the Company settled $
Other Notes Payable
The Company issued several other notes payable in 2019 and early 2020 at a
The other notes payable were amended in October 2020 to increase the interest rate to
Small Business Administration Loan
In August 2020, the Company received a U.S. Small Business Administration loan of $
Leases
Operating Lease
The Company leases office and laboratory premises in Seattle, Washington pursuant to a lease agreement that commenced in April 2011 and expires in . The agreement requires monthly lease payments, is subject to annual rent escalations during the lease term, and
Under the lease agreement, the Company is required to pay certain operating costs, in addition to rent, such as common area maintenance, taxes, utilities and insurance. Such additional charges are considered variable lease costs and are recognized in the period in which they are incurred. Rent expense for the three months ended March 31, 2023 was $
The Company’s operating leases include various covenants, indemnities, defaults, termination rights, security deposits and other provisions customary for lease transactions of this nature.
Future undiscounted payments due under the operating lease as of March 31, 2023 were as follows:
Years |
|
(in thousands) |
|
|
Remainder of 2023 |
|
$ |
|
|
2024 |
|
|
|
|
Total undiscounted lease payments |
|
|
|
|
Less: Imputed interest |
|
|
( |
) |
Operating lease liability |
|
|
|
|
Less: Operating lease liability, current portion |
|
|
( |
) |
Operating lease liability, net of current portion |
|
$ |
|
Supplemental information on the Company’s operating leases was as follows:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Cash paid for operating lease agreement (in thousands) |
|
$ |
|
|
$ |
|
||
Remaining lease term (in years) |
|
|
|
|
|
|
||
Incremental borrowing rate |
|
|
% |
|
|
% |
11
The Company subleases portions of its premises in Seattle, Washington to third parties. Under the first sublease agreement, which commenced in December 2017, the Company subleases approximately
Finance Leases
Future undiscounted payments due under finance lease liabilities as of March 31, 2023 were as follows:
Years |
|
(in thousands) |
|
|
Remainder of 2023 |
|
$ |
|
|
2024 |
|
|
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
Total undiscounted lease payments |
|
|
|
|
Less: Imputed interest |
|
|
( |
) |
Financing lease liabilities |
|
|
|
|
Less: Financing lease liabilities, current portion |
|
|
( |
) |
Financing lease liabilities, net of current portion |
|
$ |
|
Supplemental information on the Company’s financing leases was as follows (cash paid for finance lease agreements was not material):
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Weighted average remaining lease term (in years) |
|
|
|
|
|
|
||
Incremental borrowing rate |
|
|
% |
|
|
% |
Indemnification
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted under the Delaware General Corporation Law. The Company currently has directors’ and officers’ insurance.
Other Commitments
The Company has various manufacturing, clinical, research and other contracts with vendors in the conduct of the normal course of its business. Such contracts are generally terminable with advanced written notice and payment for any products or services received by the Company through the effective time of termination and any noncancelable and nonrefundable obligations incurred by the vendor at the effective time of the termination. In the case of terminating a clinical trial agreement at a particular site, the Company would also be obligated to provide continued support for appropriate medical procedures at that site until completion or termination.
Executive Employment Agreements
On September 20, 2022, the Company entered into an at-will employment agreement (“Baker Employment Agreement”), which became effective on October 3, 2022, with Keith Baker, its Chief Financial Officer. On September 28, 2022, the Company entered into at-will employment agreements (together with the Baker Employment Agreement, the “Executive Employment Agreements”), which became effective on December 16, 2022 upon the closing of the Merger, with Shawn Iadonato, its Chief Executive Officer, Craig Philips, its President and Pauline Kenny, its General Counsel.
The Executive Employment Agreements provide that, if the executive’s employment is terminated without Cause (as defined in the Executive Employment Agreements) or the executive resigns for Good Reason (as defined in the Executive Employment Agreements), provided that the executive signs the Release (as defined in the Executive Employment Agreement), the executive will be entitled to (i) accrued compensation, (ii) 39 weeks of pay (52 weeks in the case of Chief Executive Officer) (currently estimated at approximately $
12
Anti-VISTA Antibody Program License Agreement
In connection with the Company’s research into innovative immuno-oncology drug targets, the Company acquired rights to a group of fully human antibodies from Gigagen, Inc., a wholly owned subsidiary of Grifols, S.A. (“Gigagen”). Pursuant to a material transfer agreement with Gigagen dated August 2019 (the “2019 MTA”), the Company performed research activities to assess Gigagen’s anti-VISTA antibodies. Under an option and license agreement effective as of August 10, 2020, and as amended in November 2020, the parties agreed to terminate the 2019 MTA and Gigagen granted the Company a research license to continue additional evaluation of certain anti-VISTA antibodies. Gigagen also granted the Company an exclusive option to obtain an exclusive license to develop, manufacture and commercialize certain anti-VISTA antibodies during the option term commencing on the effective date and ended on December 31, 2020. The option and license agreement provides for a payment to Gigagen of $
Anti-CD27 Agonist Antibody Program License Agreement
In connection with the Company’s research into innovative immuno-oncology drug targets, the Company acquired rights to a group of fully human antibodies from Gigagen directed to CD27. Pursuant to a material transfer agreement with Gigagen dated October 28, 2020, as amended in April 2021 (the “2020 MTA”), the Company performed research activities to assess Gigagen’s anti-CD27 agonist antibodies. Under an option and license agreement effective as of June 9, 2021, as amended in August 2022, the parties agreed to terminate the 2020 MTA, Gigagen granted the Company a research license to continue additional evaluation of certain anti-CD27 agonist antibodies and also granted the Company an exclusive option to obtain an exclusive license to develop, manufacture and commercialize certain antibodies targeting CD27 during the option term commencing on the effective date and ending on December 31, 2022. The option and license agreement provides for the Company to pay Gigagen (i) an insignificant exclusivity payment within 60 days after the effective date, and (ii) an insignificant evaluation payment due by March 16, 2022. In addition, upon the Company’s exercise of its option, within 60 days after such option exercise date, the Company is obligated to, among other things, (i) pay Gigagen an upfront option exercise fee of $
The Company accounted for the acquisition of rights as an asset acquisition because it did not meet the definition of a business. From inception of the 2020 MTA through March 31, 2023,
Warrants to Purchase Common Stock
As of March 31, 2023, the Company had issued and outstanding warrants to purchase shares of the Company’s common stock as follows, which all met the condition for equity classification (in thousands):
Year |
|
Expiration |
|
Number Outstanding as of December 31, 2022 |
|
|
Issued |
|
|
Exercised |
|
|
Cancelled/Expired |
|
|
Number Outstanding as of March 31, 2023 |
|
|
Range of |
|
||||||
2013 |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||||
2017 |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||||
2019 |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||||
2020 |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||||
2022 |
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
|
$ |
|
||||
Total number of shares |
|
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
|
13
During the three months ended March 31, 2023, the Company issued
As of March 31, 2022, the Company had issued and outstanding warrants to purchase shares of the Company’s common stock as follows, which all met the condition for equity classification (in thousands):
Year |
|
Expiration |
|
Number Outstanding as of December 31, 2021 |
|
|
Issued |
|
|
Exercised |
|
|
Cancelled/Expired |
|
|
Number Outstanding as of March 31, 2022 |
|
|
Range of |
|
||||||
2013 |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||||
2017 |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||||
2019 |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||||
2020 |
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||||
Total number of shares |
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
During the three months ended March 31, 2022, the Company issued
Common Stock
As of March 31, 2023, there were
Common stock reserved for future issuance consisted of the following as the period presented:
|
|
March 31, |
|
|
|
|
(in thousands) |
|
|
Shares reserved for stock options and restricted stock units to purchase |
|
|
|
|
Shares reserved for future issuance of equity awards |
|
|
|
|
Shares reserved for exercise of warrants |
|
|
|
|
Total |
|
|
|
During the three months ended March 31, 2023, the Company sold
During the three months ended March 31, 2023, the Company issued
During the three months ended March 31, 2023, the Company issued
During the three months ended March 31, 2022, outstanding principal and accrued interest under the other notes payable of $
During the three months ended March 31, 2022, the Company sold
During the three months ended March 31, 2022, the Company issued
14
Private Placement
The Private Placement (see Note 1) provides for the issuance of shares of the Company’s common stock in two closings, one of which occurred immediately following the closing of the Merger and one of which is expected to occur on July 25, 2023. The first closing of the Private Placement occurred on December 16, 2022 and the Company issued
In connection with the Private Placement in December 2022, the Company issued
The second closing of the Private Placement is expected to occur on July 25, 2023, at which time the Company will be obligated to issue a number of shares of its common stock based on the aggregate purchase price of $
The following table shows the activity for the Company’s collaboration revenue agreement and deferred revenue (in thousands):
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
|
|
(in thousands) |
|
|||||
Balance as of beginning of period |
|
$ |
|
|
$ |
|
||
Decrease for provision of research services |
|
|
( |
) |
|
|
|
|
Balance as of end of period |
|
$ |
|
|
$ |
|
Merck & Co., Inc.
In connection with the Merger, the Company became the successor in interest to an exclusive license and research collaboration agreement (the “Merck Collaboration Agreement”) with Merck & Co., Inc. to support research, development and commercialization of products for treatment of amyotrophic lateral sclerosis and frontotemporal lobar dementia. As of December 31, 2022, the Company had $
National Institutes of Health
The Company was awarded a cost-reimbursable grant from the National Institutes of Health (the “NIH”), a federal medical research agency supporting scientific studies, to support the Company’s research studies for arenavirus hemorrhagic fever. This award was based on budgeted direct and indirect costs and may only be used for budgeted costs as allowable under certain government regulations and NIH’s policy and compliance requirements, subject to government audit. This award was $
The Company recognized grant revenue under this grant of for the three months ended March 31, 2023, and $
15
The following table shows the activity for the Company’s licensing revenue agreement and deferred revenue (in thousands):
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
|
|
(in thousands) |
|
|||||
Balance as of beginning of period |
|
$ |
|
|
$ |
|
||
Decrease for provision of research services |
|
|
|
|
|
( |
) |
|
Balance as of end of period |
|
$ |
|
|
$ |
|
Genentech, Inc.
In April 2018, the Company entered into an exclusive option and license agreement with Genentech, as amended in November 2019 and October 2020 (such agreement, as amended, the “Genentech Agreement”), to develop the Company’s α9/α10 nicotinic acetylcholine receptor (“nAChR”) antagonists for the treatment of chronic pain. On December 27, 2022, the Company through its subsidiary KCP, received written notice from Genentech of its termination of the Genentech Agreement.
The Company recognized license revenue over time of
2008 Equity Incentive Plan
The Company’s 2008 Equity Incentive Plan (the “2008 Plan”) provided for the grant of incentive stock options, non-statutory stock options, restricted stock awards and restricted stock units to employees and non-employee service providers of the Company. Under the 2008 Plan, the exercise price of stock options granted were at
In 2018, the 2008 Plan expired and only stock options granted prior to the 2008 Plan expiration remain outstanding as of March 31, 2023.
2010 Equity Incentive Plan
The Company’s 2010 Equity Incentive Plan (the “2010 Plan”) provided for the grant of incentive stock option, non-statutory stock options, stock appreciation rights, restricted stock awards and restricted stock unit awards to employees and non-employee service providers of the Company. Under the 2010 Plan, the exercise price of stock options granted were at
In February 2020, the 2010 Plan expired and only stock options granted prior to the expiration remain outstanding as of March 31, 2023. As of March 31, 2023, there were
2020 Equity Incentive Plan
The Company’s 2020 Equity Incentive Plan (the “2020 Plan”) authorizes the grant of equity awards for up to
The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options and restricted stock to employees and non-employee service providers. Under the 2020 Plan, the contractual term of stock options shall not exceed ten years and the exercise price of stock options granted shall not be less than
16
four years or the performance-based requirement. The Company has a repurchase right exercisable upon termination of continuous service with respect to restricted stock for any shares that are issued and unvested.
In December 2022, the 2020 Plan expired and only stock options granted prior to the 2020 Plan expiration remain outstanding as of March 31, 2023.
2022 Equity Incentive Plan
In December 2022, the Company approved the 2022 Equity Incentive Plan (the “2022 Plan”). The 2022 Plan provides for the grant of incentive stock option, non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights (“SARs”), performance units and performance shares to employees, directors and independent contractors of the Company. Under the 2022 Plan, the exercise price of stock options grants shall be at
Stock Option Activity
The following table summarizes stock option activity under the Company’s equity incentive plans:
|
|
Outstanding Stock Options |
|
|
Weighted-Average Exercise Price Per Share |
|
|
Weighted-Average Remaining Contractual Term (years) |
|
|
Aggregate Intrinsic Value |
|
||||
|
|
(in thousands, except per share amounts and years) |
|
|||||||||||||
December 31, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Forfeited |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
Fair Value of Stock Options
The fair value of stock options granted for employee and non-employee awards was estimated at the grant date using the Black-Scholes option pricing model based on the following assumptions:
|
|
Three Months Ended March 31, |
||
|
|
2023 |
|
2022 |
Expected volatility |
|
|
|
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
|
|
Expected dividend yield |
|
|
|
The Company did not grant any stock options during the three months ended March 31, 2023.
Restricted Stock
The Company has granted restricted stock units (“RSUs”) under its equity incentive plans with both service-based and performance-based vesting conditions. As of March 31, 2023, the Company’s outstanding RSUs all related to RSUs with performance-based conditions that vest based on meeting certain liquidity events, with a grant date fair value of $
The following table summarizes the Company’s restricted stock activity consisting of RSUs:
|
|
Number of Restricted Stock (RSUs) |
|
|
Weighted-Average Grant Date Fair Value Per Share |
|
||
|
|
(in thousands, excepts per share amounts) |
|
|||||
Outstanding and unvested as of December 31, 2022 |
|
|
|
|
$ |
|
||
Released |
|
|
( |
) |
|
$ |
|
|
Outstanding and unvested as of March 31, 2023 |
|
|
|
|
$ |
|
17
Stock-Based Compensation
The following table summarizes total stock-based compensation included in the Company’s consolidated statements of operations:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
|
|
(in thousands) |
|
|||||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Total stock-based compensation |
|
$ |
|
|
$ |
|
As of March 31, 2023, there was $
The following table summarizes the computation of basic and diluted net loss per share:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
|
|
(in thousands, excepts per share amounts) |
|
|||||
Numerator: |
|
|
|
|
|
|
||
Net loss attributable to Kineta, Inc. |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
||
Weighted-average common shares outstanding, basic and diluted |
|
|
|
|
|
|
||
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
1. Included in the denominator for the three months ended March 31, 2023 and 2022, were
The following outstanding potentially dilutive common stock equivalents were excluded from the computation of diluted net loss per share as of the periods presented because including them would have been antidilutive:
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
|
|
(in thousands) |
|
|||||
Common stock options |
|
|
|
|
|
|
||
Unvested restricted stock subject to repurchase |
|
|
|
|
|
|
||
Warrants to purchase common stock |
|
|
|
|
|
|
||
Vested restricted stock subject to recall |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
Defined Contribution Plan
The Company sponsors a 401(k) Plan whereby all employees are eligible to participate in the 401(k) Plan after meeting certain eligibility requirements. Participants may elect to have a portion of their salary deferred and contributed to the 401(k) plan, subject to certain limitations. The Company provided matching contributions of $
RSU Vesting
During the three months ended March 31, 2023, the Company issued
Notes Payable
During the three months ended March 31, 2022, the Company made a $
18
The Company evaluated subsequent events through the date these consolidated financial statements were issued.
Employee and Director Equity Awards
On April 12, 2023, the Company’s board of directors (the “Board”) granted to various employees and Board members stock options to purchase an aggregate of
Equity Raise - Registered Direct Offering
On April 20, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”), pursuant to which the Company issued and sold, in a registered direct offering priced at-the-market under the rules of The Nasdaq Stock Market (the “Registered Offering”), (i) an aggregate of
Each Pre-Funded Warrant represents the right to purchase one share of common stock at an exercise price of $
In a concurrent private placement (the “Private Placement” and, together with the Registered Offering, the “Offering”), the Company issued to the Investor warrants to purchase up to
Amendment No. 4 to the Securities Purchase Agreement
In connection and concurrently with the execution of the Merger Agreement, on June 5, 2022, the Company entered into a financing agreement, as amended on October 24, 2022, December 5, 2022, March 29, 2023 and May 1, 2023 (such financing agreement, as amended, the “Securities Purchase Agreement”), to sell shares of the Company’s common stock to certain institutional investors in a private placement (the “Private Placement”). The Company and the investors entered into the amendment to the Securities Purchase Agreement on May 1, 2023 to, among other things, extend the date of the second closing. The second closing of the Private Placement for an aggregate purchase price of $
19
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, 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.
Overview
We are a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. We have leveraged our expertise in innate immunity and are focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy.
We have established our Innate Immunity Development Platform aimed at developing fully human antibodies to address the major mechanisms of cancer immune resistance:
Utilization of our Innate Immunity Development Platform is designed to result in novel, well-characterized immuno-oncology lead antibody therapeutics that can be efficiently advanced into investigational new drug (“IND”)-enabling preclinical studies and clinical trials.
Our pipeline of assets and research interests includes (i) KVA12123 (formerly referred to as KVA12.1), a monoclonal antibody (“mAb”) immunotherapy targeting VISTA (V-domain Ig suppressor of T cell activation), (ii) an anti-CD27 agonist mAb immunotherapy and (iii) an anti-CD24 antagonist mAb immunotherapy discovery program. These immunotherapies have the potential to address disease areas with unmet medical needs and significant commercial potential.
We initiated a Phase 1 clinical trial of KVA12123 in the United States in the fourth quarter of 2022. KVA12123 is engineered to be a differentiated VISTA blocking immunotherapy to address the problem of immunosuppression in the tumor microenvironment. It is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung cancer (“NSCLC”), colorectal cancer (“CRC”), ovarian cancer (“OC”), renal cell carcinoma (“RCC”) and head and neck squamous cell carcinoma (“HNSCC”). These indications represent a significant unmet medical need with a large worldwide commercial opportunity for KVA12123.
We are also conducting preclinical studies on our lead anti-CD27 agonist mAb immunotherapy that was discovered utilizing our Innate Immunity Development Platform. This lead candidate is a fully human mAb that demonstrates low nanomolar (“nM”) binding affinity to CD27 in humans. In preclinical studies, our lead anti-CD27 agonist mAb was observed to induce T cell proliferation and secretion of cytokines involved in T cell priming and recruitment, suggesting the ability to potentiate new anti-tumor responses. CD27 is a clinically validated target that may be an effective immunotherapy for advanced solid tumors including RCC, CRC and OC. We continue to conduct preclinical studies to optimize its lead anti-CD27 agonist mAb clinical candidate.
According to Market Data Forecast, the immuno-oncology market generated sales of approximately $99 billion in 2022 and is forecast to reach $179 billion in 2027. If we successfully complete the clinical trial program for KVA12123 and we subsequently obtain regulatory approval for KVA12123, we will focus on initial target indications in NSCLC, CRC and OC. Clinical development of KVA12123 will be as a second-line therapy in these indications. These three cancer therapy segments represent a forecasted $48 billion market opportunity in 2027 according to GlobalData.
We are a leader in the field of innate immunity and are focused on developing potentially differentiated immunotherapies. With drug candidates expected to enter the clinic and additional immuno-oncology assets in preclinical development, we believe we are positioned to achieve multiple value-driving catalysts. We have assembled an experienced management team, a seasoned research and development team, an immuno-oncology focused scientific advisory board, an enabling technology platform and a leading intellectual property position to advance our pipeline of potential novel immunotherapies for cancer patients.
Since our inception in 2007, we have devoted substantially all of our resources to raising capital, licensing certain technology and intellectual property rights, identifying and developing potential product candidates, conducting research and development activities, including preclinical studies and clinical trials, organizing and staffing operations and providing general and administrative support for these operations.
We have no products approved for commercial sale and have not generated any revenue from product sales. To date, revenue has been generated from the out-licensing of certain rights to third parties, providing research services under licensing and collaboration agreements as well as revenue from government grants.
20
We have never been profitable and have incurred operating losses in each period since inception. Our net losses were $6.5 million for the three months ended March 31, 2023 and $5.0 million for the three months ended March 31, 2022. As of March 31, 2023 we had an accumulated deficit of $158.1 million.
We expect to incur significant expenses and continued operating losses for at least the next several years as we initiate and continue the clinical development of, and seek regulatory approval for, our product candidates and add personnel necessary to advance our pipeline of clinical-stage product candidates. In addition, operating as a publicly-traded company will involve the hiring of additional financial and other personnel, and the incurrence of substantial other costs associated with operating as a public company. We expect that our operating losses will fluctuate significantly from quarter to quarter and year to year due to timing of clinical development programs and efforts to achieve regulatory approval.
From inception to March 31, 2023, we have raised cash from sales and issuances of common stock and borrowings under notes payable. As of March 31, 2023, we had cash of $9.2 million. Our current capital resources, together with the $5.5 million net proceeds received in April 2023 from the registered direct offering plus the committed proceeds of $22.5 million pursuant to the second closing of the Private Placement, will be sufficient to fund operating expenses and capital expenditure requirements into early 2025. Our long term plans will require us to raise substantial additional capital to continue our clinical development and potential commercialization activities. Accordingly, we will need to raise substantial additional capital to continue to fund our long-term plans. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on our financial condition and our ability to develop our product candidates.
Private Placement
In connection and concurrently with the execution of the Merger Agreement, on June 5, 2022, we entered into a financing agreement, as amended on October 24, 2022, December 5, 2022, March 29, 2023 and May 1, 2023 (such financing agreement, as amended, the “Securities Purchase Agreement”), with certain investors to sell shares of our common stock to such investors in a private placement (the “Private Placement”). We and the investors entered into the amendment to the Securities Purchase Agreement on May 1, 2023 to, among other things: (i) extend the date of the second closing from May 31, 2023 to July 25, 2023.
The first closing of the Private Placement occurred on December 16, 2022 and we issued 649,346 shares of our common stock and received net proceeds of $7.4 million. The second closing of the Private Placement for an aggregate purchase price of $22.5 million is expected to occur on July 25, 2023.
The Merger has been accounted for as a reverse merger and asset acquisition in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Under this method of accounting, Private Kineta was deemed to be the accounting acquirer for financial reporting purposes, primarily based on the fact that, immediately following the Merger: (i) Private Kineta’s shareholders own a majority (80%) of the common stock of the Company, (ii) Private Kineta designated a majority of the members of the initial board of directors of the combined organization and (iii) Private Kineta’s senior management hold all key positions in the senior management of the combined organization.
Geopolitical Developments
Geopolitical developments, such as the Russian invasion of Ukraine or deterioration in the bilateral relationship between the United States and China, may impact government spending, international trade and market stability, and cause weaker macro-economic conditions. The impact of these developments, including any resulting sanctions, export controls or other restrictive actions that may be imposed against governmental or other entities in, for example, Russia, have in the past contributed and may in the future contribute to disruption, instability and volatility in the global markets, which in turn could adversely impact our operations and weaken our financial results. Certain political developments may also lead to uncertainty to regulations and rules that may materially affect our business.
At-the-Market Offering Program
In February 2023, we entered into a sales agreement (the “Sales Agreement”) with Jefferies with respect to an at-the-market (“ATM”) offering program under which we may issue and sell, from time to time and at our sole discretion, shares of our common stock, in an aggregate offering amount of up to $17.5 million, subject to the offering limits in General Instruction I.B.6 to Form S-3. Jefferies acts as our sales agent and will use commercially reasonable efforts to sell shares of common stock from time to time, based upon instruction from us. We will pay Jefferies 3.0% of the gross proceeds from the sales of any common stock sold pursuant to the Sales Agreement.
On April 19, 2023, we delivered written notice to Jefferies that we were suspending and terminating the prospectus supplement (the “ATM Prospectus Supplement”) related to our common stock issuable pursuant to the Sales Agreement. We will not make any sales of our securities pursuant to the Sales Agreement, unless and until a new prospectus supplement is filed. Other than the termination and suspension of the ATM Prospectus Supplement, the Sales Agreement remains in full force and effect.
During the three months ended March 31, 2023, we sold 126,503 shares of our common stock to individual investors under the Sales Agreement and received net proceeds of $0.8 million in connection with the ATM equity offering program.
21
Registered Direct Offering
On April 20, 2023, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”), pursuant to which we issued and sold, in a registered direct offering priced at-the-market under the rules of The Nasdaq Stock Market (the “Registered Offering”), (i) an aggregate of 948,000 shares of our common stock, at a purchase price of $4.21 per share and (ii) pre-funded warrants exercisable for up to 477,179 shares of our common stock (the “Pre-Funded Warrants”) to the Investor at a purchase price of $4.209 per Pre-Funded Warrant, for aggregate gross proceeds from the Offering (as defined below) of approximately $6.0 million before deducting the placement agent fee (as described in greater detail below) and related offering expenses.
Each Pre-Funded Warrant represents the right to purchase one share of common stock at an exercise price of $0.001 per share. The Pre-Funded Warrants are exercisable immediately and may be exercised at any time until the Pre-Funded Warrants are exercised in full.
In a concurrent private placement (the “Private Placement” and, together with the Registered Offering, the “Offering”), we issued to the Investor warrants to purchase up to 1,425,179 shares of common stock (the “Common Warrants”) at an exercise price of $4.08 per share. The Common Warrants are exercisable immediately and will expire five and one-half years from the initial exercise date.
In connection with the Offering, we entered into an engagement letter (the “Engagement Letter”) with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which Wainwright agreed to serve as the exclusive placement agent for the issuance and sale of securities of the Company pursuant to the Purchase Agreement. As compensation for such placement agent services, we paid Wainwright an aggregate cash fee equal to $420,000, a non-accountable expense of $35,000 and $50,000 for legal and other expenses as actually incurred. On April 24, 2023, we also issued to Wainwright or its designees warrants to purchase 71,259 shares of common stock (the “Wainwright Warrants”). The Wainwright Warrants have a term of five years from the commencement of sales in the Offering, and have an exercise price of $5.2625 per share.
Financial Operations Overview
Revenues
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales in the near future. Our revenues have been primarily derived from our collaboration, research and license agreements as well as grants awarded by government agencies.
Collaboration Revenues
In connection with the Merger, we became the successor in interest to an exclusive license and research collaboration agreement (the “Merck Collaboration Agreement”) with Merck & Co., Inc. to support research, development and commercialization of products for treatment of amyotrophic lateral sclerosis and frontotemporal lobar dementia. We recognize revenue using the cost-to-cost method, which we believe best depicts the transfer of control to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation. Under this method, revenue is recognized as a percentage of actual cost incurred to the estimated costs to complete.
Licensing Revenues
Our license agreements may include the transfer of intellectual property rights in the form of licenses, promises to provide research and development services and promises to participate on certain development committees with the collaboration party. The terms of such agreements include payment to us of one or more of the following: nonrefundable upfront fees, payment for research and development services, development, regulatory and commercial milestone payments and sales-based milestones and royalties on net sales of licensed products.
Revenue associated with nonrefundable upfront license fees where the license fees and research and development activities cannot be accounted for as separate performance obligations is deferred and recognized as revenue over the expected period of performance based on a cost-based input method. Revenue from contingent development, regulatory and commercial milestones, when not deemed probable of significant reversal of cumulative revenue, is also recognized over the performance period based on a similar method. Where we have no remaining performance obligations, revenue from such milestones is recognized when the accomplishment of the milestones is deemed probable. Our license agreement with Genentech was terminated in December 2022 and we do not expect to recognize any revenue from the Genentech Agreement during 2023.
Grant Revenues
Under our grant agreements with government-sponsored and charitable organizations, we receive payment for providing research and development services. Revenue associated with grant arrangements is based on a cost-based reimbursement model that recognizes revenue over time as we perform work under the grants and incur qualifying research and development costs.
We have completed research and development services under the grant agreements and do not expect to recognize any revenue during 2023.
Operating Expenses
Research and Development Expenses
22
Research and development expenses represent costs incurred in connection with the discovery, research, preclinical and clinical development, and manufacture of our product candidates. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:
The largest component of our operating expenses has historically been our investment in research and development activities. We expect our research and development expenses will increase in the future as we advance our product candidates into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support and contract manufacturing. In addition, we continue to evaluate opportunities to acquire or in-license other product candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development costs.
As we are working on multiple research and development programs at any one time, we track our external expenses by the stage of program, clinical or preclinical. However, our internal expenses, including unallocated costs, personnel costs and infrastructure costs, are not directly related to any one program and are deployed across multiple programs. As such, we do not track internal expenses on a specific program basis.
The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely developing and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our future product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and stock-based compensation for personnel in executive, finance and accounting, and other administrative functions, as well as fees paid for legal, accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and patent costs. We expect to incur additional expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services.
Other (Expense) Income
Interest Expense
Interest expense consists of interest charged on outstanding borrowings associated with our debt arrangements primarily consisting of borrowings under several notes payable agreements.
Change in Fair Value Measurement of Notes Payable
Change in fair value of notes payable relates to the remeasurement of the notes payable that we elected to account for under the fair value option. Until settlement, these notes payable are remeasured at fair value at each reporting period with the changes in fair value recorded through the statement of operations.
(Loss) Gain on Extinguishments of Debt, Net
(Loss) gain on extinguishments of debt, net consists of the (loss) gain upon settlement of our notes payable and other debt.
23
Other (Expense) Income, Net
Other (expense) income, net consists of items that are of a non-recurring nature and primarily relate to items that are immaterial.
Net (Loss) Income Attributable to Noncontrolling Interest
Net (loss) income attributable to noncontrolling interest reflects investors’ share of net (loss) income in our majority owned subsidiaries.
Results of Operations
Comparison of the Three Months Ended March 31, 2023 and 2022
The following table summarizes our results of operations for the periods presented:
|
|
Three Months Ended March 31, |
|
|
|
|
||||||
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|||||||||
Revenues: |
|
|
|
|
|
|
|
|
|
|||
Collaboration revenues |
|
$ |
281 |
|
|
$ |
— |
|
|
$ |
281 |
|
Licensing revenues |
|
|
— |
|
|
|
358 |
|
|
|
(358 |
) |
Grant revenues |
|
|
— |
|
|
|
75 |
|
|
|
(75 |
) |
Total revenues |
|
|
281 |
|
|
|
433 |
|
|
|
(152 |
) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
2,843 |
|
|
|
4,023 |
|
|
|
(1,180 |
) |
General and administrative |
|
|
3,924 |
|
|
|
1,609 |
|
|
|
2,315 |
|
Total operating expenses |
|
|
6,767 |
|
|
|
5,632 |
|
|
|
1,135 |
|
Loss from operations |
|
|
(6,486 |
) |
|
|
(5,199 |
) |
|
|
(1,287 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|||
Interest expense |
|
|
(23 |
) |
|
|
(584 |
) |
|
|
561 |
|
Change in fair value of measurement of notes payable |
|
|
(6 |
) |
|
|
142 |
|
|
|
(148 |
) |
Gain on extinguishments of debt expense |
|
|
— |
|
|
|
669 |
|
|
|
(669 |
) |
Other income (expense), net |
|
|
35 |
|
|
|
(3 |
) |
|
|
38 |
|
Total other (expense) income, net |
|
|
6 |
|
|
|
224 |
|
|
|
(218 |
) |
Net loss |
|
|
(6,480 |
) |
|
|
(4,975 |
) |
|
|
(1,505 |
) |
Net income (loss) attributable to noncontrolling interest |
|
|
(29 |
) |
|
|
1 |
|
|
|
(30 |
) |
Net loss attributable to Kineta, Inc. |
|
$ |
(6,451 |
) |
|
$ |
(4,976 |
) |
|
$ |
(1,475 |
) |
Revenues
Collaboration revenues were $281,000 for the three months ended March 31, 2023 and zero for the three months ended March 31, 2022 as a result of research services provided under the Merck Collaboration Agreement pursuant to which the Company became a successor in interest in connection with the Merger. Upon completion of the Merger, we had $442,000 in deferred revenue under the Merck Collaboration Agreement. As of March 31, 2023, we had $161,000 in deferred revenue under the Merck Collaboration Agreement and expect to provide services to complete this project and recognize the remaining $161,000 of revenue during the three months ending June 30, 2023.
Licensing revenues were zero for the three months ended March 31, 2023 and $358,000 for the three months ended March 31, 2022 as this license agreement was terminated in December 2022.
Grant revenues were zero for the three months ended March 31, 2023 and $75,000 three months ended March 31, 2022 as this grant was concluded in December 2022.
24
Research and Development Expenses
The following table summarizes our research and development expenses by program and category for the periods presented:
|
|
Three Months Ended March 31, |
|
|
|
|
||||||
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|||||||||
Direct external program expenses: |
|
|
|
|
|
|
|
|
|
|||
KVA12123 program |
|
$ |
1,784 |
|
|
$ |
2,504 |
|
|
$ |
(720 |
) |
CD27 program |
|
|
271 |
|
|
|
185 |
|
|
|
86 |
|
KCP-506 program |
|
|
104 |
|
|
|
34 |
|
|
|
70 |
|
Other programs |
|
|
— |
|
|
|
94 |
|
|
|
(94 |
) |
Internal and unallocated expenses: |
|
|
|
|
|
|
|
|
|
|||
Personnel-related costs |
|
|
349 |
|
|
|
890 |
|
|
|
(541 |
) |
Facilities and related costs |
|
|
300 |
|
|
|
222 |
|
|
|
78 |
|
Other costs |
|
|
35 |
|
|
|
94 |
|
|
|
(59 |
) |
Total research and development expenses |
|
$ |
2,843 |
|
|
$ |
4,023 |
|
|
$ |
(1,180 |
) |
Research and development expenses decreased by $1.2 million, or 29%, to $2.8 million for the three months ended March 31, 2023 from $4.0 million for the three months ended March 31, 2022. The decrease in direct external program expenses of $0.7 million was primarily due to lower activities for KVA12123 as we began securing clinical trial sites and enrolling patients in advance of enrolling the first patient, which occurred in April 2023. We expect our direct external program expenses to increase over time this year as we enroll and dose additional patients. The decrease in our internal and unallocated research and development expenses of $0.5 million was primarily due to lower personnel costs as a result of reducing research and development staff in December 2022 as we transition to clinical trials.
General and Administrative Expenses
General and administrative expenses increased by $2.3 million, or 144%, to $3.9 million for the three months ended March 31, 2023 from $1.6 million for the three months ended March 31, 2022. The increase was primarily attributable to an increase of $1.1 million in personnel costs driven by stock-based compensation expense from RSUs with performance conditions contingent upon the closing of the Merger and higher headcount. There was $643,000 in stock-based compensation expense from RSUs for the three months ended March 31, 2023 and zero for the three months ended March 31, 2022 since performance conditions of closing the Merger were not met until December 2022. In addition, we incurred higher professional services and consultant fees, primarily driven by legal, accounting and consulting costs as we became a public company.
Interest Expense
Interest expense decreased by $563,000, or 96%, to $23,000 for the three months ended March 31, 2023 from $586,000 for the three months ended March 31, 2022, due to a significantly lower balance of notes in 2023 as the majority of notes were converted to equity in December 2022.
Change in Fair Value Measurement of Notes Payable
Change in fair value of notes payable was a $6,000 loss for the three months ended March 31, 2023 and was a gain of $142,000 for the three months ended March 31, 2022, due to a significantly lower balance of notes in 2023 as the majority of notes were converted to equity in December 2022.
Gain on Extinguishments of Debt
Gain on extinguishments of debt was zero for the three months ended March 31, 2023 and $669,000 for the three months ended March 31, 2022 due to the settlement of notes payable accounted for under the fair value election. There was no settlement of notes payable during the three months ended March 31, 2022.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception through March 31, 2023, our operations have been financed primarily by net cash proceeds from the sale and issuance of our common stock and borrowings under notes payable. We have also received upfront payments from our license agreements. As of March 31, 2023, we had $9.2 million in cash and an accumulated deficit of $158.1 million. We expect that our operating expenses will increase, and, as a result, anticipate that we will continue to incur increasing losses for the foreseeable future. Therefore, we will need to raise additional capital to fund our operations, which may be through the issuance of additional equity or through borrowings.
During the three months ended March 31, 2023, we issued 127,000 shares of our common stock to individual investors and received net proceeds of $0.8 million in connection with the ATM equity offering program.
25
Future Funding Requirements
Our revenues to date have been primarily derived from our collaboration, research and license agreements as well as grants awarded by government agencies. We, however, have not generated any revenue from product sales, and do not know when, or if, we will generate any revenue from product sales. We do not expect to generate any revenue from product sales unless and until we obtain regulatory approval of and commercialize any of our product candidates. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seeks regulatory approval for, our product candidates. In addition, subject to obtaining regulatory approval of any of our product candidates, we anticipate that we will need substantial additional funding in connection with our continuing operations. We plan to continue to fund our operations and capital requirements through equity and/or debt financing, but there are no assurances that we will be able to raise sufficient amounts of funding in the future on acceptable terms, or at all.
Our future funding requirements will depend on many factors, including:
As of March 31, 2023, we had cash of $9.2 million. Our current capital resources, together with the $5.5 million net proceeds received in April 2023 from the registered direct offering plus the committed proceeds of $22.5 million pursuant to the second closing of the Private Placement, will be sufficient to fund our operating expenses and capital expenditure requirements into early 2025.
However, until we can generate a sufficient amount of product revenue to finance our cash requirements, we expect to finance our future cash needs primarily through the issuance of additional equity, borrowings and strategic alliances with partner companies. To the extent that we raise additional capital through the issuance of additional equity or convertible debt securities, the ownership interest of our shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of existing shareholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourselves.
Cash Flows
The following table summarizes our cash flows for the periods indicated:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
|
|
(in thousands) |
|
|||||
Net cash provided by (used in): |
|
|
|
|||||
Operating activities |
|
$ |
(4,940 |
) |
|
$ |
(5,376 |
) |
Investing activities |
|
|
285 |
|
|
|
(15 |
) |
Financing activities |
|
|
750 |
|
|
|
(1,509 |
) |
Net change in cash and cash equivalents |
|
$ |
(3,905 |
) |
|
$ |
(6,900 |
) |
26
Operating Activities
Cash used in operating activities for the three months ended March 31, 2023 was $4.9 million, consisting of a net loss of $6.5 million, partially offset by noncash charges of $1.2 million and a change in other net operating assets and liabilities of $0.4 million. The noncash charges primarily consisted of $1.1 million in stock-based compensation and $0.2 million noncash operating lease expense, partially offset by a $0.1 million gain on disposal of fixed assets. Our change in net operating assets and liabilities primarily resulted from a $3.2 million increase in accounts payable, partially offset by a $2.5 million reduction in accrued expenses and other current liabilities, a $0.2 million decrease in operating lease liability and a $0.3 million decrease in deferred revenue due to recognition of collaboration revenue in connection with the Merck Collaboration Agreement.
Cash used in operating activities for the three months ended March 31, 2022 was $5.4 million, consisting of a net loss of $5.0 million and noncash charges of $0.2 million and a change in other net operating assets and liabilities of $0.2 million. The noncash charges primarily consisted of a $0.7 million gain on debt extinguishment and $0.1 million in change in fair value measurement of notes payable, partially offset by $0.3 million in stock-based compensation and $0.2 million in noncash operating lease expense. The change in net operating assets and liabilities primarily resulted from a $0.6 million reduction in accrued expenses, $0.4 million decrease in deferred revenue due to recognition of license revenue in connection with the Genentech Agreement and a $0.2 million decrease in operating lease liability, partially offset by a $1.1 million increase in accounts payable due to the timing of payments.
Investing Activities
Cash provided by investing activities for the three months ended March 31, 2023 was $0.3 million, consisting primarily of cash received from the sale of certain property and equipment. Cash used in investing activitites for the three months ended March 31, 2022 was insignificant.
Financing Activities
Cash provided by financing activities for the three months ended March 31, 2023 was $0.8 million, primarily related to net proceeds from the issuance of our common stock to investors pursuant to the Sale Agreement.
Cash used in financing activities for the three months ended March 31, 2022 was $1.5 million, primarily related to $4.0 million for partial repayment of notes payable, partially offset by $2.4 million in borrowing of notes payable.
Debt Obligations
Notes Payable
As of March 31, 2023, we had outstanding notes payable in an aggregate principal amount of $0.8 million at interest rates that range from 3.75% to 6%, of which no payments are due within the next 12 months. The principal amount of each note payable is due at a specified periodic repayment date and/or at maturity, with such dates ranging from June 2024 to on or after September 2050.
See Note 5 to our consolidated financial statements included in this Quarterly Report for additional information regarding our notes payable.
Other Contractual Obligations and Commitments
Our cash requirements greater than 12 months are related to other contractual obligations and commitments related to license agreements and leases.
We have entered into a number of strategic license agreements pursuant to which we have acquired rights to specific assets, technology and intellectual property. In accordance with these agreements, we are obligated to pay, among other items, future contingent payments that are dependent upon future events such as our achievement of certain development, regulatory and commercial milestones royalties, and sublicensing revenue in the future, as applicable. As of March 31, 2023, the timing and likelihood of achieving the milestones and generating future product sales, and therefore payments that may become payable to these third parties, are uncertain.
We lease office and laboratory space for our corporate headquarters in Seattle, Washington under a lease agreement that expires in July 2024. As of March 31, 2023, undiscounted future minimum lease payments of $1.3 million remain pursuant to the lease agreement.
In addition, we enter into agreements in the normal course of business with various third parties for preclinical research studies, clinical trials, testing and other research and development services. Such agreements generally provide for termination upon notice, although obligate us to reimburse vendors for any time or costs incurred through the date of termination.
Critical Accounting Estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, and related disclosures. Our estimates are based on historical experience and on various assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual
27
results may differ materially from these estimates. Our critical accounting estimates used in the preparation of our financial statements for the three months ended March 31, 2023 were consistent with those in Part II, Item 7 of our Annual Report on Form 10-K.
We believe that the accounting principles used in the preparation of our financial statements for the three months ended March 31, 2023 were consistent with those in Part II, Item 7 of our Annual Report on Form 10-K.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company, as defined in Rule 12b-2 under the Exchange Act, for this reporting period and are not required to provide the information required under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Prior to completion of the Merger, we were a private company and had limited accounting and financial reporting personnel and other resources with which to address our internal controls and related procedures. In connection with the audit of our financial statements for the years ended December 31, 2022 and 2021, our management and our independent registered public accounting firm identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting as defined under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and by the Public Company Accounting Oversight Board (United States), such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. The material weakness for the year ended December 31, 2022 relates to accounting for complex financial instruments related to warrants issued to certain existing stockholders. The material weaknesses for the year ended December 31, 2021 relate to segregation of duties in finance and internal technical resources for complex transactions.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the fiscal quarter ended March 31, 2023. Based on this evaluation and for the reasons set forth above, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of March 31, 2023.
We are in the process of implementing measures designed to improve our internal control over financial reporting to remediate the material weaknesses. For example, we began to address the material weaknesses by implementing certain Sarbanes-Oxley controls during the first half of 2022. In October 2022, we hired a Chief Financial Officer to enhance internal controls and address the material weaknesses and other control deficiencies identified during the 2021 audit of the financial statements. We also plan to design and implement improved processes and internal controls, including ongoing senior management review and audit committee oversight. Additionally, we plan to further develop and implement formal policies, processes and documentation procedures relating to our financial reporting, including the oversight of third-party service providers. Our actions are subject to ongoing executive management review and will also be subject to audit committee oversight.
Notwithstanding the material weaknesses in internal control over financial reporting described above, our management has concluded that our consolidated financial statements included in this Quarterly Report on Form 10-Q are fairly stated in all material respects in accordance with accounting principles generally accepted in the United States of America.
Changes in Internal Control over Financial Reporting
Except as disclosed above, there has been no change in our internal control over financial reporting that occurred during the first quarter of 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over current or future financial reporting.
28
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, Kineta may be a party to litigation or subject to claims incident to the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, Kineta currently believes that the final outcome of these ordinary course matters will not have a material adverse effect on Kineta’s business. Regardless of the outcome, litigation can have an adverse impact on Kineta because of defense and settlement costs, diversion of management resources and other factors. Kineta is currently not a party to any material legal proceedings.
Item 1A. Risk Factors.
There have been no material changes to our risk factors included in our 2022 Annual Report on Form 10-K, other than the following:
Kineta has a limited operating history, has incurred net losses since its inception, and anticipates that it will continue to incur significant losses for the foreseeable future. Kineta may never generate any revenue or become profitable or, if Kineta achieves profitability, may not be able to sustain it.
Kineta is a clinical-stage biotechnology company with a limited operating history that may make it difficult to evaluate the success of Kineta’s business to date and to assess its future viability. Kineta’s operations to date have been limited to organizing and staffing its company, business planning, raising capital, developing and optimizing its technology platform, identifying potential product candidates, undertaking research, preclinical studies and clinical trials for its product candidates, establishing and enhancing its intellectual property portfolio, and providing general and administrative support for these operations. Kineta’s KVA12123, KCP506 and LHF535 programs are in early clinical development, and Kineta’s CD27 program is in preclinical development. None of Kineta’s product candidates have been approved for commercial sale. Kineta has never generated any revenue from product sales and has incurred net losses each year since Kineta commenced operations. Kineta’s net losses were $6.5 million for the three months ended March 31, 2023 and $5.0 million for the three months ended March 31, 2022. Kineta expects that it will be several years, if ever, before it has a product candidate ready for regulatory approval and commercialization. Kineta expects to incur increasing levels of operating losses over the next several years and for the foreseeable future as Kineta advances its product candidates through clinical development. Kineta’s prior losses, combined with expected future losses, have had and will continue to have an adverse effect on Kineta’s stockholders’ deficit and working capital.
To become and remain profitable, Kineta must develop and eventually commercialize a product or products with significant market potential. This will require Kineta to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of its product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing and selling those products for which Kineta may obtain marketing approval and satisfying any post-marketing requirements. Kineta may never succeed in these activities and, even if Kineta succeeds in commercializing one or more of its product candidates, Kineta may never generate revenue that is significant or large enough to achieve profitability. In addition, as a young business, Kineta may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown challenges. If Kineta does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis and Kineta will continue to incur substantial research and development and other expenditures to develop and market additional product candidates. Kineta’s failure to become and remain profitable would decrease the value of its company 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 the company could also cause Kineta’s stockholders to lose all or part of their investment.
Kineta has incurred recurring net losses and negative cash flows from operations since inception and, as of March 31, 2023, had an accumulated deficit of $158.1 million. The net loss attributable to Kineta was $6.5 million for the three months ended March 31, 2023. As of March 31, 2023, Kineta had unrestricted cash of $9.2 million. Kineta’s cash as of March 31, 2023, together with the $5.5 million net proceeds received in April 2023 from the registered direct offering plus the committed proceeds of $22.5 million pursuant to the second closing of the Private Placement, will be sufficient to fund operating expenses and capital expenditure requirements into early 2025. Kineta will need to raise additional capital to support its long-term plans and to complete clinical trials. Kineta intends to raise additional debt and equity financing from its current investors as well as prospective investors and intends to continue to pursue federal grant funding and may receive milestone payments from its license agreements, or other sources. However, there is no guarantee that any of these additional financing or opportunities will be executed or realized on acceptable terms, if at all. Kineta’s ability to raise additional capital through either the issuance of equity or debt is dependent on a number of factors including, but not limited to, Company prospects, which itself is subject to a number of development and business risks and uncertainties, as well as uncertainty about whether Kineta would be able to raise such additional capital at a price or on terms that are acceptable.
If Kineta continues to experience operating losses, and it is not able to generate additional liquidity through a capital raise or other cash infusion, Kineta might need to secure additional sources of funds, which may or may not be available to it. If Kineta is unable to raise additional capital in sufficient amounts or on terms acceptable to it, Kineta may have to significantly delay, scale back or discontinue the development of its product candidates or other research and development initiatives or take initial steps to cease operations.
29
Kineta will need to obtain substantial additional funding to complete the development and commercialization of its product candidates. If Kineta is unable to raise this capital when needed, Kineta may be forced to delay, reduce or eliminate its product development programs or other operations.
Since its inception, Kineta has used substantial amounts of cash to fund its operations and expects its expenses to increase substantially during the next few years. The development of biopharmaceutical product candidates, especially immuno-oncology product candidates, is capital intensive. As Kineta’s product candidates enter and advance through preclinical studies and clinical trials, Kineta will need substantial additional funds to expand its clinical, regulatory, quality and manufacturing capabilities. In addition, if Kineta obtains marketing approval for any of its product candidates, Kineta expects to incur significant commercialization expenses related to marketing, sales, manufacturing and distribution. Furthermore, Kineta expects to incur additional costs associated with operating as a public company.
As of March 31, 2023, Kineta had $9.2 million in cash. Based upon Kineta’s current operating plan, Kineta estimates that its existing cash as of March 31, 2023, together with the $5.5 million net proceeds received in April 2023 from the registered direct offering plus the committed proceeds of $22.5 million pursuant to the second closing of the Private Placement expected to occur on July 25, 2023, will be sufficient to fund operating expenses and capital expenditure requirements into early 2025. However, the expected net proceeds from the second closing of the Private Placement may not be sufficient to fund any of Kineta’s product candidates through regulatory approval, and Kineta may need to raise substantial additional capital to complete the development and commercialization of its product candidates.
Kineta has based these estimates on assumptions that may prove to be incorrect or require adjustment as a result of business decisions, and Kineta could utilize its available capital resources sooner than it currently expects. Kineta’s future capital requirements will depend on many factors, some of which are outside of its control, including:
30
Kineta will require additional capital to achieve its business objectives. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable Kineta to continue to implement its long-term business strategy. Further, Kineta’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. If Kineta is unable to raise sufficient additional capital, Kineta could be forced to curtail its planned operations and the pursuit of its growth strategy.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On March 29, 2023, the Company issued 12,295 shares of its common stock to a consultant in consideration for services under a consulting agreement. The shares were valued at $6.10 per share, the closing price of the common stock on the day prior to the execution date of the consulting agreement. The Company issued the shares of common stock in reliance on an exemption from registration provided by Section 4(a)(2) of the Securities Act for transactions not involving any public offering.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
31
Item 6. Exhibits.
Exhibit Number |
|
Description |
2.1++ |
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|
2.2 |
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3.1 |
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3.2 |
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3.3 |
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3.4 |
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3.5 |
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3.6 |
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4.1 |
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4.2 |
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4.3 |
|
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10.1 |
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10.2 |
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31.1* |
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31.2* |
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32.1* |
|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* Filed herewith.
++ Certain schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request.
32
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
Kineta, Inc. |
|
|
|
|
|
Date: May 11, 2023 |
|
By: |
/s/ Shawn Iadonato |
|
|
|
Shawn Iadonato, Ph.D. |
|
|
|
Chief Executive Officer and Director |
|
|
|
(Principal Executive Officer) |
|
|
|
|
Date: May 11, 2023 |
|
By: |
/s/ Keith A. Baker |
|
|
|
Keith A. Baker |
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial Officer) |
33
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Shawn Iadonato, certify that:
Date: May 11, 2023 |
|
|
/s/ Shawn Iadonato |
|
|
|
Shawn Iadonato |
|
|
|
Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Keith A. Baker, certify that:
Date: May 11, 2023 |
|
|
/s/ Keith A. Baker |
|
|
|
Keith A. Baker |
|
|
|
Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Kineta, Inc. (the “Company”) for the three months ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: May 11, 2023 |
|
|
/s/ Shawn Iadonato |
|
|
|
Shawn Iadonato |
|
|
|
Chief Executive Officer |
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|
|
|
Date: May 11, 2023 |
|
|
/s/ Keith A. Baker |
|
|
|
Keith A. Baker |
|
|
|
Chief Financial Officer |
The foregoing certification is being furnished solely pursuant to 18 U.S.C. § 1350 and is not being filed as part of the Report or as a separate disclosure document.
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 8,531,000 | 8,318,000 |
Common stock, shares outstanding | 8,531,000 | 8,318,000 |
Condensed Condensed Consolidated Statements of Operations (Parenthetical) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Income Statement [Abstract] | ||
Interest expense, related party | $ 0 | $ 489 |
Organization and Liquidity |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Liquidity | 1. Organization and Liquidity Description of Business
Kineta, Inc. (formerly Yumanity Therapeutics, Inc.) (together with its subsidiaries, the “Company”) is headquartered in Seattle, Washington.
The Company is a clinical-stage biotechnology company focused on developing new innovative therapies in the field of immuno-oncology and cancer. The Company also has drug programs in neurology (chronic pain) and an antiviral drug program in development for arenaviruses such as Lassa fever. Kineta Chronic Pain, LLC (“KCP”) was formed to develop new innovative therapies for pain management. Kineta Viral Hemorrhagic Fever, LLC (“KVHF”) was formed to develop a direct acting anti-viral therapy for the treatment of emerging diseases. As of March 31, 2023 and December 31, 2022, the Company owns a majority interest of the outstanding issued equity of KCP and all of the outstanding issued equity of KVHF. Private Placement
In connection and concurrently with the execution of the Merger Agreement, on June 5, 2022, the Company entered into a financing agreement, as amended on October 24, 2022, December 5, 2022, March 29, 2023 and May 1, 2023 (such financing agreement, as amended, the “Securities Purchase Agreement”), to sell shares of the Company’s common stock in a private placement (the “Private Placement”). The first closing of the Private Placement occurred on December 16, 2022, and the Company issued 649,346 shares of its common stock and received net proceeds of $7.4 million. The second closing of the Private Placement for an aggregate purchase price of $22.5 million is expected to occur on July 25, 2023. Liquidity The Company has incurred recurring net losses and negative cash flows from operations since inception and, as of March 31, 2023, had an accumulated deficit of $158.1 million. The net loss attributable to the Company was $6.5 million for the three months ended March 31, 2023. As of March 31, 2023, the Company had unrestricted cash of $9.2 million. The Company’s cash as of March 31, 2023, together with the $5.5 million net proceeds received in April 2023 from the registered direct offering plus the committed proceeds of $22.5 million pursuant to the second closing of the Private Placement, will be sufficient to fund operating expenses and capital expenditure requirements into early 2025.
The Company will need to raise additional capital to support its long-term plans and to complete clinical trials. The Company intends to raise additional debt and equity financings from its current investors as well as prospective investors and may receive milestone payments from its license agreements, or other sources. However, there is no guarantee that any of these additional financings or opportunities will be executed or realized on acceptable terms, if at all. The Company’s ability to raise additional capital through either the issuance of equity or debt is dependent on a number of factors including, but not limited to, Company prospects, which itself is subject to a number of development and business risks and uncertainties, as well as uncertainty about whether the Company would be able to raise such additional capital at a price or on terms that are acceptable. Geopolitical Developments Geopolitical developments, such as the Russian invasion of Ukraine or deterioration in the bilateral relationship between the United States and China, may impact government spending, international trade and market stability, and cause weaker macro-economic conditions. The impact of these developments, including any resulting sanctions, export controls or other restrictive actions that may be imposed against governmental or other entities in, for example, Russia, have in the past contributed and may in the future contribute to disruption, instability and volatility in the global markets, which in turn could adversely impact the Company’s operations and weaken the Company’s financial results. Certain political developments may also lead to uncertainty to regulations and rules that may materially affect the Company’s business. |
Summary of Significant Accounting Policies |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies
Unaudited Interim Financial Information The unaudited condensed consolidated balance sheet as of December 31, 2022 was derived from the Company’s audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America (“U.S. GAAP”). The accompanying unaudited condensed consolidated financial statements, as of March 31, 2023 and for the three months ended March 31, 2023, are unaudited and have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. The Company believes that the disclosures are adequate to make the information presented not misleading. There have been no changes to the Company’s significant accounting policies described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023 (the “2022 Annual Report on Form 10-K”). These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2022 included in the 2022 Annual Report on Form 10-K. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of March 31, 2023 and condensed consolidated results of operations and cash flows for the three months ended March 31, 2023 and 2022 have been made. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.
Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable SEC rules regarding annual financial reporting. The condensed consolidated financial statements include all accounts of the Company, its majority owned subsidiary KCP, and its wholly owned subsidiary, KVHF. All intercompany transactions and balances have been eliminated upon consolidation. Noncontrolling interest in the accompanying condensed consolidated financial statements represents the proportionate share of equity which is not held by the Company. Net income (loss) of the non-wholly owned consolidated subsidiary is allocated to the Company and the holder(s) of the noncontrolling interests in proportion to their percentage ownership considering any preferences specific to the form of equity of the subsidiaries. Revenue Recognition Collaboration Revenues
In connection with the Merger, the Company became the successor in interest to an exclusive license and research collaboration agreement (the “Merck Collaboration Agreement”) with Merck & Co., Inc. to support research, development and commercialization of products for treatment of amyotrophic lateral sclerosis and frontotemporal lobar dementia. As of March 31, 2023, the Company had $161,000 in deferred revenue under the Merck Collaboration Agreement. The Company recognizes revenue using the cost-to-cost method, which it believes best depicts the transfer of control to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation. Under this method, revenue is recognized as a percentage of actual cost incurred to the estimated costs to complete.
Accounting Pronouncements Recently Adopted
Effective January 1, 2023, the Company adopted Accounting Standards Update (“ASU”) 2020-08, “Codification Improvements to Subtopic 718-740, Compensation—Stock Compensation”. This ASU makes several improvements to the guidance in Subtopic 718-740, which addresses stock compensation. The adoption of ASU 2020-08 did not have a material impact on the consolidated financial statements. |
Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | 3. Fair Value Measurements The carrying amounts of the Company’s financial instruments, including cash, restricted cash, and accounts payable, approximate fair value due to the short-term nature of those instruments.
2022 & 2020 Notes Payable
The Company elected the fair value option to account for certain convertible notes payable and notes payable, referred to as the 2022 convertible notes, 2020 convertible notes and 2020 notes (see Note 5), respectively, and collectively the 2022 & 2020 notes payable. The 2020 convertible notes and 2020 notes are referred to as the 2020 notes payable. Upon the closing of the Merger in December 2022, the 2022 convertible notes and 2020 convertible notes were settled with shares of the Company’s common stock (see Note 5). 2020 Notes The 2020 notes were valued using a discounted cash flow model based on the contractual payment dates, a discount rate and the contractual maturity date. The significant unobservable inputs used in the fair value measurement of the 2020 note for the three months ended March 31, 2023 were as follows: discount rate of 15.0% and contractual payment date of 1.3 years, which resulted in a fair value range for the 2020 note of $225,000. The significant unobservable inputs used in the fair value measurement of the 2020 notes for the three months ended March 31, 2022 were as follows: discount rate of 19.5% and contractual payment dates ranging from 0.3 to 1.2 years, which resulted in a fair value for the 2020 notes of $1.6 million.
2020 Convertible Notes
The 2020 convertible notes were valued using a scenario-based analysis and a discounted cash flow model. Two primary scenarios were considered: the qualified financing scenario and the repayment scenario. The value of the 2020 convertible notes under each scenario was probability weighted to arrive at the estimated fair value for the notes. The qualified financing scenario considers the value impact of conversion at the stated discount to the issue price if the Company completes a qualifying financing event before the maturity date. The repayment scenario considers payment of principal at the contractual maturity dates.
The significant unobservable inputs used in the fair value measurement of the 2020 convertible notes for the three months ended March 31, 2022 were as follows: discount rate of 13.0% and contractual payment dates ranging from of 0.5 to 1.0 years, which resulted in a fair value for the 2020 convertible notes ranging from $0.9 million to $5.8 million.
2022 Convertible Notes
The 2022 convertible notes were valued using a scenario-based analysis and a discounted cash flow model. Two primary scenarios were considered: the qualified financing scenario and the automatic conversion scenario. The value of the 2022 convertible notes under each scenario was probability weighted to arrive at the estimated fair value for the notes. The qualified financing scenario considers the value impact of conversion at the stated discount to the issue price if the Company completes a qualifying financing event before the maturity date. The automatic conversion scenario estimates the timing of such conversion. The significant unobservable inputs used in the fair value measurement of the 2020 notes for the three months ended March 31, 2022 were as follows: discount rate of 33.6% and contractual payment dates ranging from 0.3 years to 1.0 years, which resulted in a fair value of the 2022 convertible notes of $2.5 million. The following table provides a summary of the changes in the fair value of the Company’s 2022 & 2020 notes payable measured using Level 3 inputs:
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Balance Sheet Components |
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Statement Of Financial Position [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance Sheet Components | 4. Balance Sheet Components Property and Equipment, Net Property and equipment, net consisted of the following:
Depreciation and amortization expense was $2,000 for the three months ended March 31, 2023 and $16,000 for the three months ended March 31, 2022. The Company has acquired certain laboratory equipment under agreements that are classified as finance leases. The carrying value of the equipment under finance leases included in the balance sheet as property and equipment was zero as of March 31, 2023 and $0.1 million as of December 31, 2022, net of accumulated depreciation. During the three months ended March 31, 2023, the Company disposed of assets with a net carrying value of $175,000 and received proceeds of $285,000. The Company recorded a gain on disposal of fixed assets, which is recorded in other income (expense) in the Statement of Operations.
Rights from Private Placement In connection and concurrently with the execution of the Merger Agreement, on June 5, 2022, the Company entered into a financing agreement, as amended on October 24, 2022, December 5, 2022, March 29, 2023 and May 1, 2023, to sell shares of the Company’s common stock in a private placement (the “Private Placement”). The first closing of the Private Placement occurred on December 16, 2022, and the Company issued 649,346 shares of its common stock and received net proceeds of $7.4 million. The second closing of the Private Placement for an aggregate purchase price of $22.5 million is expected to occur on July 25, 2023. With respect to the second closing, the Company is obligated to sell and issue a number of shares of its common stock and the investors are obligated to buy such shares by the specified date and price equal to the volume-weighted average price of Company common stock for the five trading days prior to July 25, 2023 (“VWAP”) plus 10% of the VWAP. The Company has recorded a $2.3 million rights from Private Placement asset as of December 31, 2022 for the future right associated with the second closing.
Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following as of the periods presented:
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Notes Payable |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Note Payable | 5. Notes Payable Notes payable outstanding consisted of the following as of the periods presented:
The Company elected the fair value option for the 2020 notes (see Note 3). The other notes payable and Small Business Administration loan approximate their fair value because interest rates are at prevailing market rates. Expected future minimum principal payments under the Company’s notes payables as of March 31, 2023 were as follows:
2020 Notes In October 2020, the Company refinanced certain notes payable (the “2020 notes”), with an aggregate principal amount of $3.0 million with various investors, including one investor that is a related party (see Note 14). The interest rate was reduced on the 2020 notes from 16.0% to 6.0% from October 2020 until the earlier of (i) the Company raises at least $25.0 million in a single transaction or series of transactions after October 2020 and (ii) the original maturity dates (that is, various dates in the first quarter of 2022), after which the interest rate increases to 16.0%. The outstanding principal is due upon demand of the majority of the lenders with respect to (i) 50% on or after nine months after the original maturity date (or on or after various dates in the fourth quarter of 2022) and (ii) 50% on or after fifteen months after the original maturity date (or on or after various dates in the second quarter of 2023). The Company may repay the 2020 notes at any time without penalty. Upon bankruptcy the lender can accelerate all amounts due immediately.
In August 2022, the Company settled $1.4 million in outstanding principal and accrued interest by issuing 59,000 shares of the Company’s non-voting common stock at a 15% discount. The Company extended the maturity date for the remaining 2020 notes with a principal balance of $250,000 to July 31, 2024 and reduced the interest rate to 6%, which was accounted for as a modification. Other Notes Payable The Company issued several other notes payable in 2019 and early 2020 at a 12.0% interest rate per annum, with the principal amounts due in full at maturity and interest due monthly or quarterly. The other notes payable were due to mature at various dates between December 2020 through early 2022. The other notes payable were amended in October 2020 to increase the interest rate to 13.0% and extend the maturity date to be on demand by a majority of the holders on or after April 7, 2022, which resulted in a modification of the other notes payable. The Company may prepay the other notes payable at any time without penalty. In April 2022, the Company extended the maturity date for the remaining other notes payable with a principal balance of $0.4 million to June 30, 2024 and decreased the interest rate to 6.0% interest, which was accounted for as a modification. Small Business Administration Loan In August 2020, the Company received a U.S. Small Business Administration loan of $150,000 at a 3.75% interest rate and maturing in . Repayments of principal are due monthly beginning in June 2027 and interest is due monthly. |
Commitments and Contingencies |
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Commitments And Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | 6. Commitments and Contingencies Leases Operating Lease
The Company leases office and laboratory premises in Seattle, Washington pursuant to a lease agreement that commenced in April 2011 and expires in . The agreement requires monthly lease payments, is subject to annual rent escalations during the lease term, and contains two five-year options to extend the lease term. In June 2020, the Company amended the lease agreement to reduce the leased space for the premises from approximately 22,064 square feet to approximately 14,870 square feet, which was accounted for as a lease modification and partial termination of the lease.
Under the lease agreement, the Company is required to pay certain operating costs, in addition to rent, such as common area maintenance, taxes, utilities and insurance. Such additional charges are considered variable lease costs and are recognized in the period in which they are incurred. Rent expense for the three months ended March 31, 2023 was $237,000 and variable costs were $172,000. Rent expense for the three months ended March 31, 2022 was $208,000 and variable costs were $137,000.
The Company’s operating leases include various covenants, indemnities, defaults, termination rights, security deposits and other provisions customary for lease transactions of this nature.
Future undiscounted payments due under the operating lease as of March 31, 2023 were as follows:
Supplemental information on the Company’s operating leases was as follows:
The Company subleases portions of its premises in Seattle, Washington to third parties. Under the first sublease agreement, which commenced in December 2017, the Company subleases approximately 1,850 square feet. In October 2020 the sublease expiration date was extended from December 2020 to December 2022. In September 2022, the sublease expiration date was extended from December 2022 to December 2023. Under the second sublease agreement, which commenced in January 2019 and expired in June 2020, the Company subleased approximately 7,194 square feet. Sublease income was $49,000 for the three months ended March 31, 2023 and $46,000 for three months ended March 31, 2022 and recorded within operating expenses. As of March 31, 2023, the total minimum rentals to be received under the remaining noncancelable sublease was $120,000.
Finance Leases
Future undiscounted payments due under finance lease liabilities as of March 31, 2023 were as follows:
Supplemental information on the Company’s financing leases was as follows (cash paid for finance lease agreements was not material):
Indemnification In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted under the Delaware General Corporation Law. The Company currently has directors’ and officers’ insurance. Other Commitments The Company has various manufacturing, clinical, research and other contracts with vendors in the conduct of the normal course of its business. Such contracts are generally terminable with advanced written notice and payment for any products or services received by the Company through the effective time of termination and any noncancelable and nonrefundable obligations incurred by the vendor at the effective time of the termination. In the case of terminating a clinical trial agreement at a particular site, the Company would also be obligated to provide continued support for appropriate medical procedures at that site until completion or termination. Executive Employment Agreements On September 20, 2022, the Company entered into an at-will employment agreement (“Baker Employment Agreement”), which became effective on October 3, 2022, with Keith Baker, its Chief Financial Officer. On September 28, 2022, the Company entered into at-will employment agreements (together with the Baker Employment Agreement, the “Executive Employment Agreements”), which became effective on December 16, 2022 upon the closing of the Merger, with Shawn Iadonato, its Chief Executive Officer, Craig Philips, its President and Pauline Kenny, its General Counsel.
The Executive Employment Agreements provide that, if the executive’s employment is terminated without Cause (as defined in the Executive Employment Agreements) or the executive resigns for Good Reason (as defined in the Executive Employment Agreements), provided that the executive signs the Release (as defined in the Executive Employment Agreement), the executive will be entitled to (i) accrued compensation, (ii) 39 weeks of pay (52 weeks in the case of Chief Executive Officer) (currently estimated at approximately $1.3 million in the aggregate), (iii) nine (9) months of COBRA benefits (12 months in the case of Chief Executive Officer) for executive and eligible dependents, and (iv) three (3) additional months of vesting of unvested and outstanding equity awards. If executive’s employment is terminated without Cause or the executive resigns for Good Reason within the Change in Control Protection Period (as defined in the Executive Employment Agreements), then in addition to (i)-(iv) above, executive will receive current year pro-rated cash bonus. |
Strategic License Agreements |
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License Agreements Disclosure [Abstract] | |
Strategic License Agreements | 7. Strategic License Agreements Anti-VISTA Antibody Program License Agreement In connection with the Company’s research into innovative immuno-oncology drug targets, the Company acquired rights to a group of fully human antibodies from Gigagen, Inc., a wholly owned subsidiary of Grifols, S.A. (“Gigagen”). Pursuant to a material transfer agreement with Gigagen dated August 2019 (the “2019 MTA”), the Company performed research activities to assess Gigagen’s anti-VISTA antibodies. Under an option and license agreement effective as of August 10, 2020, and as amended in November 2020, the parties agreed to terminate the 2019 MTA and Gigagen granted the Company a research license to continue additional evaluation of certain anti-VISTA antibodies. Gigagen also granted the Company an exclusive option to obtain an exclusive license to develop, manufacture and commercialize certain anti-VISTA antibodies during the option term commencing on the effective date and ended on December 31, 2020. The option and license agreement provides for a payment to Gigagen of $0.2 million within five days after the effective date. In addition, upon the Company’s exercise of its option during the option term, within 60 days after such date the Company is obligated to, among other things, (i) pay Gigagen an upfront option exercise fee of $0.4 million, and (ii) issue Gigagen non-voting common stock of the Company having an aggregate then-current fair market value of $0.25 million. The Company is also obligated to pay Gigagen (i) development and regulatory milestones up to an aggregate of $20.3 million based on achievement of certain predetermined milestones, (ii) sales milestones up to an aggregate of $8.0 million based on net sales thresholds, and (iii) royalties in the low-single digits on net sales for each licensed product sold by the Company during the term of the agreement. The Company accounted for the acquisition of rights as an asset acquisition because it did not meet the definition of a business. The Company recorded the upfront payment to Gigagen as research and development expense in the consolidated statements of operations because the acquired rights represented in-process research and development that have no alternative future use. From inception of the 2019 MTA through March 31, 2023, the Company has incurred $0.25 million in milestone expense and zero in royalties under the 2019 MTA. Anti-CD27 Agonist Antibody Program License Agreement In connection with the Company’s research into innovative immuno-oncology drug targets, the Company acquired rights to a group of fully human antibodies from Gigagen directed to CD27. Pursuant to a material transfer agreement with Gigagen dated October 28, 2020, as amended in April 2021 (the “2020 MTA”), the Company performed research activities to assess Gigagen’s anti-CD27 agonist antibodies. Under an option and license agreement effective as of June 9, 2021, as amended in August 2022, the parties agreed to terminate the 2020 MTA, Gigagen granted the Company a research license to continue additional evaluation of certain anti-CD27 agonist antibodies and also granted the Company an exclusive option to obtain an exclusive license to develop, manufacture and commercialize certain antibodies targeting CD27 during the option term commencing on the effective date and ending on December 31, 2022. The option and license agreement provides for the Company to pay Gigagen (i) an insignificant exclusivity payment within 60 days after the effective date, and (ii) an insignificant evaluation payment due by March 16, 2022. In addition, upon the Company’s exercise of its option, within 60 days after such option exercise date, the Company is obligated to, among other things, (i) pay Gigagen an upfront option exercise fee of $0.4 million, and (ii) issue Gigagen non-voting common stock of the Company having an aggregate then-current fair market value of $0.25 million. The Company is also obligated to pay Gigagen (i) development and regulatory milestones up to an aggregate of $20.0 million based on achievement of certain predetermined milestones, (ii) sales milestones up to an aggregate of $8.0 million based on net sales thresholds, and (iii) royalties in the low-single digits on net sales for each licensed product sold by the Company during the term of the agreement. The Company accounted for the acquisition of rights as an asset acquisition because it did not meet the definition of a business. From inception of the 2020 MTA through March 31, 2023, none of the milestones have been achieved and no royalties were due under the agreement. |
Shareholders' Equity |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shareholders' Equity | 8. Stockholders’ Equity Warrants to Purchase Common Stock As of March 31, 2023, the Company had issued and outstanding warrants to purchase shares of the Company’s common stock as follows, which all met the condition for equity classification (in thousands):
During the three months ended March 31, 2023, the Company issued 51,000 shares of its common stock upon exercise of warrants and received proceeds of $7,000. The exercise price of all shares exercised was $0.14.
As of March 31, 2022, the Company had issued and outstanding warrants to purchase shares of the Company’s common stock as follows, which all met the condition for equity classification (in thousands):
During the three months ended March 31, 2022, the Company issued 1,175 shares of its common stock upon exercise of warrants and received proceeds of $171. The exercise price of all shares exercised was $0.14. Common Stock As of March 31, 2023, there were 8,531,000 shares of common stock issued and outstanding. Common stock reserved for future issuance consisted of the following as the period presented:
During the three months ended March 31, 2023, the Company sold 126,503 shares of its common stock to individual investors under the Sales Agreement (as defined below) and received net proceeds of $0.8 million in connection with the ATM (as defined below) equity offering program. During the three months ended March 31, 2023, the Company issued 23,000 shares of its common stock upon vesting of restricted stock units. 19,000 shares were issued to members of the Company’s executive management, 2,000 shares were issued to directors of the Company and 2,000 were issued to other employees. During the three months ended March 31, 2023, the Company issued 12,000 shares of its common stock for professional services and recorded $41,000 as consulting expense within general and administrative expense. During the three months ended March 31, 2022, outstanding principal and accrued interest under the other notes payable of $235,000 was settled by issuing 9,000 shares of the Company’s common stock at fair value (based on a recent valuation) to the holders. During the three months ended March 31, 2022, the Company sold 3,000 shares of its common stock to individual investors and received net proceeds of $98,000. During the three months ended March 31, 2022, the Company issued 1,175 shares of its common stock upon exercise of warrants and received proceeds of $171. The exercise price of all shares exercised was $0.14. Private Placement
The Private Placement (see Note 1) provides for the issuance of shares of the Company’s common stock in two closings, one of which occurred immediately following the closing of the Merger and one of which is expected to occur on July 25, 2023. The first closing of the Private Placement occurred on December 16, 2022 and the Company issued 649,346 shares of its common stock and received net proceeds of $7.4 million to investors that are related parties.
In connection with the Private Placement in December 2022, the Company issued 104,000 warrants to purchase shares of the Company’s non-voting common stock to investors in the Private Placement, each at an exercise price of $0.14, with exercise contingent upon the Merger closing and exercisable following the first closing of the Private Placement. The Company determined the contingent exercise provisions were indexed to the Company’s operations and the warrants qualified for equity classification.
The second closing of the Private Placement is expected to occur on July 25, 2023, at which time the Company will be obligated to issue a number of shares of its common stock based on the aggregate purchase price of $22.5 million divided by the purchase price equal to (a) the volume-weighted average price of Company common stock for the five trading days prior to July 25, 2023 (“VWAP”), plus (b) 10% of the VWAP. The Company determined that its obligation to issue additional shares of its common stock in the second closing at a premium to the VWAP was a freestanding financial instrument and a future right, which is subject to fair value. Accordingly, at inception the future right was recorded as an other asset in the Company’s consolidated balance sheet at its fair value equal to 10% of the second closing amount, or $2.3 million. The remaining proceeds from the first closing were allocated to the shares of common stock issued in the first closing and to the warrants as such instruments are equity-classified. The future right is subject to remeasurement at each reporting date, however, as the fair value will always equal 10% of the value of the future second closing until settlement, no changes in fair value are expected to be recorded in the Company’s consolidated statements of operations. The Company incurred insignificant issuance costs related to the Private Placement. |
Collaboration Agreement |
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Collaboration Agreement | 9. Collaboration Agreement
The following table shows the activity for the Company’s collaboration revenue agreement and deferred revenue (in thousands):
Merck & Co., Inc.
In connection with the Merger, the Company became the successor in interest to an exclusive license and research collaboration agreement (the “Merck Collaboration Agreement”) with Merck & Co., Inc. to support research, development and commercialization of products for treatment of amyotrophic lateral sclerosis and frontotemporal lobar dementia. As of December 31, 2022, the Company had $442,000 in deferred revenue under the Merck Collaboration Agreement. The Company recognized $281,000 in revenue for the three months ended March 31, 2023 and zero for the three months ended March 31, 2022. As of March 31, 2023, the Company had $161,000 in deferred revenue under the Merck Collaboration Agreement. |
Grants Agreements |
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Research And Development [Abstract] | |
Grant Agreements | 10. Grant Agreements National Institutes of Health The Company was awarded a cost-reimbursable grant from the National Institutes of Health (the “NIH”), a federal medical research agency supporting scientific studies, to support the Company’s research studies for arenavirus hemorrhagic fever. This award was based on budgeted direct and indirect costs and may only be used for budgeted costs as allowable under certain government regulations and NIH’s policy and compliance requirements, subject to government audit. This award was $1.1 million for the budget period January 2021 to December 2021, which was later extended to December 31, 2022. The Company recognized grant revenue under this grant of for the three months ended March 31, 2023, and $75,000 for the three months ended March 31, 2022. |
Licensing Revenue Agreement |
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Licensing Revenue Agreement | 11. Licensing Revenue Agreement The following table shows the activity for the Company’s licensing revenue agreement and deferred revenue (in thousands):
Genentech, Inc. In April 2018, the Company entered into an exclusive option and license agreement with Genentech, as amended in November 2019 and October 2020 (such agreement, as amended, the “Genentech Agreement”), to develop the Company’s α9/α10 nicotinic acetylcholine receptor (“nAChR”) antagonists for the treatment of chronic pain. On December 27, 2022, the Company through its subsidiary KCP, received written notice from Genentech of its termination of the Genentech Agreement.
The Company recognized license revenue over time of zero under the Genentech Agreement with Genentech for the three months ended March 31, 2023, and $358,000 for the three months ended March 31, 2022. There was no deferred revenue related to this license as of March 31, 2023 as the Genentech Agreement was terminated in December 2022. |
Stock-Based Compensation |
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Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | 12. Stock-Based Compensation
2008 Equity Incentive Plan
The Company’s 2008 Equity Incentive Plan (the “2008 Plan”) provided for the grant of incentive stock options, non-statutory stock options, restricted stock awards and restricted stock units to employees and non-employee service providers of the Company. Under the 2008 Plan, the exercise price of stock options granted were at 100% of the estimated fair market value of the Company’s common stock on the date of grant and the contractual term of stock options granted were between five and ten years. Options become vested and, if applicable, exercisable based on terms determined by the Company’s board of directors or other plan administrator on the date of grant, which is continued employment or service as defined in each option agreement.
In 2018, the 2008 Plan expired and only stock options granted prior to the 2008 Plan expiration remain outstanding as of March 31, 2023.
2010 Equity Incentive Plan
The Company’s 2010 Equity Incentive Plan (the “2010 Plan”) provided for the grant of incentive stock option, non-statutory stock options, stock appreciation rights, restricted stock awards and restricted stock unit awards to employees and non-employee service providers of the Company. Under the 2010 Plan, the exercise price of stock options granted were at 100% of the estimated fair market value of the Company’s common stock on the date of grant and the contractual term of stock options granted did not exceed ten years. Options become vested and, if applicable, exercisable based on terms determined by the Company’s board of directors or other plan administrator on the date of grant, which is continued employment or service as defined in each option agreement. Stock appreciation rights (“SARs”) provide a participant with the right to receive the aggregate appreciation in stock price over the market price of the Company’s common stock at the date of grant, payable in cash. The rights granted have varying vesting terms, including SARs that vest immediately on the grant date and upon satisfaction of the service-based requirement, typically three to five years. The maximum fair value is limited to four times the exercise price.
In February 2020, the 2010 Plan expired and only stock options granted prior to the expiration remain outstanding as of March 31, 2023. As of March 31, 2023, there were no SARs outstanding.
2020 Equity Incentive Plan
The Company’s 2020 Equity Incentive Plan (the “2020 Plan”) authorizes the grant of equity awards for up to 206,000 shares of the Company’s voting common stock and 206,000 of the Company’s non-voting common stock.
The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options and restricted stock to employees and non-employee service providers. Under the 2020 Plan, the contractual term of stock options shall not exceed ten years and the exercise price of stock options granted shall not be less than 100% of the estimated fair market value of the Company’s common stock on the date of grant. However, the exercise price of incentive stock options granted to a 10% stockholder shall not be less than 110% of the fair market value of the common stock on the date of grant and the contractual term shall not exceed ten years. Options become vested and, if applicable, exercisable based on terms determined by the Company’s board of directors or other plan administrator on the date of grant, which is continued employment or service as defined in each option agreement. Restricted stock has vesting terms that vest immediately on the grant date or upon satisfaction of the service-based requirement, typically four years or the performance-based requirement. The Company has a repurchase right exercisable upon termination of continuous service with respect to restricted stock for any shares that are issued and unvested.
In December 2022, the 2020 Plan expired and only stock options granted prior to the 2020 Plan expiration remain outstanding as of March 31, 2023.
2022 Equity Incentive Plan
In December 2022, the Company approved the 2022 Equity Incentive Plan (the “2022 Plan”). The 2022 Plan provides for the grant of incentive stock option, non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights (“SARs”), performance units and performance shares to employees, directors and independent contractors of the Company. Under the 2022 Plan, the exercise price of stock options grants shall be at 100% fair market value of the Company’s common stock on the date of grant and the contractual term of stock options granted shall not exceed ten years. Options become vested and, if applicable, exercisable based on terms determined by the Company’s board of directors or other plan administrator on the date of grant, which is continued employment or service as defined in each option agreement. SARs provide a participant with the right to receive the aggregate appreciation in stock price over the market price of the Company’s common stock at the date of grant, payable in cash or in shares of equivalent value. Stock Option Activity The following table summarizes stock option activity under the Company’s equity incentive plans:
Fair Value of Stock Options
The fair value of stock options granted for employee and non-employee awards was estimated at the grant date using the Black-Scholes option pricing model based on the following assumptions:
The Company did not grant any stock options during the three months ended March 31, 2023.
Restricted Stock The Company has granted restricted stock units (“RSUs”) under its equity incentive plans with both service-based and performance-based vesting conditions. As of March 31, 2023, the Company’s outstanding RSUs all related to RSUs with performance-based conditions that vest based on meeting certain liquidity events, with a grant date fair value of $4.1 million. The following table summarizes the Company’s restricted stock activity consisting of RSUs:
Stock-Based Compensation The following table summarizes total stock-based compensation included in the Company’s consolidated statements of operations:
As of March 31, 2023, there was $2.4 million of unrecognized stock-based compensation related to stock options and RSUs outstanding, which is expected to be recognized over a weighted-average remaining service period of 1.1 years. |
Net Loss Per Share |
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Net Loss Per Share | 13. Net Loss Per Share The following table summarizes the computation of basic and diluted net loss per share:
1. Included in the denominator for the three months ended March 31, 2023 and 2022, were 520,000 and 234,000 weighted-average shares of common stock warrants, respectively, with an exercise price of $0.14 issued for nominal consideration. The following outstanding potentially dilutive common stock equivalents were excluded from the computation of diluted net loss per share as of the periods presented because including them would have been antidilutive:
Defined Contribution Plan
The Company sponsors a 401(k) Plan whereby all employees are eligible to participate in the 401(k) Plan after meeting certain eligibility requirements. Participants may elect to have a portion of their salary deferred and contributed to the 401(k) plan, subject to certain limitations. The Company provided matching contributions of $40,000 for the three months ended March 31, 2023 and $41,000 for the three months ended March 31, 2022. |
Related Party Transactions |
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Related Party Transactions [Abstract] | |
Related Party Transactions | 14. Related Party Transactions
RSU Vesting During the three months ended March 31, 2023, the Company issued 23,000 shares of its common stock upon vesting of restricted stock units. 19,000 shares were issued to members of the Company’s executive management and 2,000 shares were issued to directors of the Company. Notes Payable During the three months ended March 31, 2022, the Company made a $4.0 million cash payment of principal to one of its creditors that is a director of the Company as a partial repayment for a note issued pursuant to the 2020 convertible notes and recognized a $669,000 gain on extinguishment. |
Subsequent Events |
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Subsequent Events | 15. Subsequent Events The Company evaluated subsequent events through the date these consolidated financial statements were issued.
Employee and Director Equity Awards
On April 12, 2023, the Company’s board of directors (the “Board”) granted to various employees and Board members stock options to purchase an aggregate of 1,171,920 shares of common stock at an exercise price of $3.28 per share. Included in the grant were an option to purchase 207,000 shares of common stock to Shawn Iadonato, Chief Executive Officer; an option to purchase 165,600 shares of common stock to Craig Philips, President; an option to purchase 120,060 shares of common stock to Keith Baker, Chief Financial Officer; an option to purchase 120,060 shares of common stock to Pauline Kenny, General Counsel; an option to purchase 120,060 shares of common stock to Thierry Guillaudeux, Chief Scientific Officer; an option to purchase 20,000 shares of common stock to each of David Arkowitz and Richard Peters, each a member of the Board, pursuant to his appointment to the Board; an option to purchase 12,500 shares of common stock to each of Raymond Bartoszek, Marion R. Foote, David Arkowitz and Richard Peters, each a member of the Board, pursuant to an annual Board award grant; and 349,140 shares of common stock to other employees. These stock option grants were issued under the 2022 Equity Incentive Plan. The option awards granted to Dr. Iadonato, Mr. Philips, Mr. Baker, Ms. Kenny and Dr. Guillaudeux vested 25% on the date of grant and the remaining shares vest 1/36th monthly over 36 months beginning May 1, 2023. The option awards granted to Mr. Arkowitz and Dr. Peters pursuant to their appointment to the Board vest 1/36th monthly over 36 months beginning February 1, 2023. The option awards granted to Mr. Bartoszek, Ms. Foote, Mr. Arkowitz and Dr. Peters for their annual Board award grant vest 1/12th monthly over 12 months beginning July 7, 2023.
Equity Raise - Registered Direct Offering
On April 20, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”), pursuant to which the Company issued and sold, in a registered direct offering priced at-the-market under the rules of The Nasdaq Stock Market (the “Registered Offering”), (i) an aggregate of 948,000 shares of its common stock, at a purchase price of $4.21 per share and (ii) pre-funded warrants exercisable for up to 477,179 shares of its common stock (the “Pre-Funded Warrants”) to the Investor at a purchase price of $4.209 per Pre-Funded Warrant, for aggregate gross proceeds from the Offerings (as defined below) of approximately $6.0 million before deducting the placement agent fee (as described in greater detail below) and related offering expenses.
Each Pre-Funded Warrant represents the right to purchase one share of common stock at an exercise price of $0.001 per share. The Pre-Funded Warrants are exercisable immediately and may be exercised at any time until the Pre-Funded Warrants are exercised in full.
In a concurrent private placement (the “Private Placement” and, together with the Registered Offering, the “Offering”), the Company issued to the Investor warrants to purchase up to 1,425,179 shares of common stock (the “Common Warrants”) at an exercise price of $4.08 per share. The Common Warrants are exercisable immediately and will expire five and one-half years from the initial exercise date. In connection with the Offering, the Company entered into an engagement letter (the “Engagement Letter”) with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which Wainwright agreed to serve as the exclusive placement agent for the issuance and sale of securities of the Company pursuant to the Purchase Agreement. As compensation for such placement agent services, the Company paid Wainwright an aggregate cash fee equal to $420,000, a non-accountable expense of $35,000 and $50,000 for legal and other expenses as actually incurred. The total offering-related fees were approximately $520,000, which resulted in net proceeds to the Company of $5.5 million. On April 24, 2023, the Company also issued to Wainwright or its designees warrants to purchase 71,259 shares of common stock (the “Wainwright Warrants”). The Wainwright Warrants have a term of five years from the commencement of sales in the Offering, and have an exercise price of $5.2625 per share.
Amendment No. 4 to the Securities Purchase Agreement
In connection and concurrently with the execution of the Merger Agreement, on June 5, 2022, the Company entered into a financing agreement, as amended on October 24, 2022, December 5, 2022, March 29, 2023 and May 1, 2023 (such financing agreement, as amended, the “Securities Purchase Agreement”), to sell shares of the Company’s common stock to certain institutional investors in a private placement (the “Private Placement”). The Company and the investors entered into the amendment to the Securities Purchase Agreement on May 1, 2023 to, among other things, extend the date of the second closing. The second closing of the Private Placement for an aggregate purchase price of $22.5 million is expected to occur on July 25, 2023. |
Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable SEC rules regarding annual financial reporting. The condensed consolidated financial statements include all accounts of the Company, its majority owned subsidiary KCP, and its wholly owned subsidiary, KVHF. All intercompany transactions and balances have been eliminated upon consolidation. Noncontrolling interest in the accompanying condensed consolidated financial statements represents the proportionate share of equity which is not held by the Company. Net income (loss) of the non-wholly owned consolidated subsidiary is allocated to the Company and the holder(s) of the noncontrolling interests in proportion to their percentage ownership considering any preferences specific to the form of equity of the subsidiaries. |
Revenue Recognition | Revenue Recognition Collaboration Revenues
In connection with the Merger, the Company became the successor in interest to an exclusive license and research collaboration agreement (the “Merck Collaboration Agreement”) with Merck & Co., Inc. to support research, development and commercialization of products for treatment of amyotrophic lateral sclerosis and frontotemporal lobar dementia. As of March 31, 2023, the Company had $161,000 in deferred revenue under the Merck Collaboration Agreement. The Company recognizes revenue using the cost-to-cost method, which it believes best depicts the transfer of control to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation. Under this method, revenue is recognized as a percentage of actual cost incurred to the estimated costs to complete. |
Accounting Pronouncements Recently Adopted | Accounting Pronouncements Recently Adopted
Effective January 1, 2023, the Company adopted Accounting Standards Update (“ASU”) 2020-08, “Codification Improvements to Subtopic 718-740, Compensation—Stock Compensation”. This ASU makes several improvements to the guidance in Subtopic 718-740, which addresses stock compensation. The adoption of ASU 2020-08 did not have a material impact on the consolidated financial statements. |
Fair Value Measurements (Tables) |
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Summary of Changes in Fair Value of 2022 & 2020 Notes Payable Measured Using Level 3 Inputs | The following table provides a summary of the changes in the fair value of the Company’s 2022 & 2020 notes payable measured using Level 3 inputs:
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Balance Sheet Components (Tables) |
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Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following:
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Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following as of the periods presented:
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Notes Payable (Tables) |
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Schedule of Notes Payable | Notes payable outstanding consisted of the following as of the periods presented:
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Schedule of Expected Future Minimum Principal | Expected future minimum principal payments under the Company’s notes payables as of March 31, 2023 were as follows:
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Commitments and Contingencies (Tables) |
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments And Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Operating Lease Future Undiscounted Payments | Future undiscounted payments due under the operating lease as of March 31, 2023 were as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Operating Leases Supplemental Information | Supplemental information on the Company’s operating leases was as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Finance Lease Future Undiscounted Payments | Future undiscounted payments due under finance lease liabilities as of March 31, 2023 were as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Finance Leases Supplemental Information | Supplemental information on the Company’s financing leases was as follows (cash paid for finance lease agreements was not material):
|
Shareholders' Equity (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Warrants to Purchase | As of March 31, 2023, the Company had issued and outstanding warrants to purchase shares of the Company’s common stock as follows, which all met the condition for equity classification (in thousands):
|
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Schedule of Common Stock for Future Issuance | Common stock reserved for future issuance consisted of the following as the period presented:
|
Collaboration Agreement (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition And Deferred Revenue [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of collaboration revenue agreement and deferred revenue | The following table shows the activity for the Company’s collaboration revenue agreement and deferred revenue (in thousands):
|
Licensing Revenue Agreement - (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition And Deferred Revenue [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Licensing Revenue Agreements And Deferred Revenue | The following table shows the activity for the Company’s licensing revenue agreement and deferred revenue (in thousands):
|
Stock-Based Compensation (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Stock Option Activity | The following table summarizes stock option activity under the Company’s equity incentive plans:
|
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Summary of Fair Value of Stock Options Granted for Employee and Non-Employee Awards | The fair value of stock options granted for employee and non-employee awards was estimated at the grant date using the Black-Scholes option pricing model based on the following assumptions:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Companies Restricted Stock Activity | The following table summarizes the Company’s restricted stock activity consisting of RSUs:
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Summary of Total Stock-Based Compensation | The following table summarizes total stock-based compensation included in the Company’s consolidated statements of operations:
|
Net Loss Per Share (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Basic and Diluted Net Loss per Share | The following table summarizes the computation of basic and diluted net loss per share:
1. Included in the denominator for the three months ended March 31, 2023 and 2022, were 520,000 and 234,000 weighted-average shares of common stock warrants, respectively, with an exercise price of $0.14 issued for nominal consideration. |
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Schedule of Antidilutive Securities Excluded from Computation of Diluted Weighted-average Shares Outstanding | The following outstanding potentially dilutive common stock equivalents were excluded from the computation of diluted net loss per share as of the periods presented because including them would have been antidilutive:
|
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Dec. 31, 2022 |
|
Summary Of Significant Accounting Policies [Line Items] | ||
Deferred Revenue | $ 161,000 | |
Accounting Standards Update 2021-04 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in accounting principle accounting standards update, adopted | true | |
Change in accounting principle accounting standards update, immaterial effect | true |
Reverse Merger (Additional Information) (Details) - $ / shares |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Business Acquisition [Line Items] | ||
Common Stock Shares Authorized | 125,000,000 | 125,000,000 |
Common Stock Par Or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock Shares Outstanding | 8,531,000 | 8,318,000 |
Fair Value Measurements - Summary of Changes in Fair Value of 2022 & 2020 Notes Payable Measured Using Level 3 Inputs (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Balance at beginning of period | $ 748 | $ 17,830 |
Issuance of 2022 convertible notes | 0 | 2,400 |
Change in fair value of 2022 & 2020 notes payable | 6 | (142) |
Change in fair value of debt extinguishment | 0 | (669) |
Partial settelement of 2020 notes payable | 0 | (4,000) |
Balance at end of period | $ 754 | $ 15,419 |
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Balance Sheet Components [Line Items] | ||
Total property and equipment | $ 146 | $ 866 |
Less: Accumulated depreciation and amortization | 74 | 617 |
Total property and equipment, net | 72 | 249 |
Laboratory Equipment | ||
Balance Sheet Components [Line Items] | ||
Total property and equipment | 60 | 779 |
Computer and Software | ||
Balance Sheet Components [Line Items] | ||
Total property and equipment | 72 | 73 |
Leasehold Improvements | ||
Balance Sheet Components [Line Items] | ||
Total property and equipment | $ 14 | $ 14 |
Balance Sheet Components - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Balance Sheet Components [Abstract] | ||
Professional services | $ 336 | $ 2,176 |
Compensation and benefits | 486 | 745 |
Accrued clinical trial and preclinical costs | 22 | 404 |
Accrued interest | 141 | 132 |
Other | 67 | 70 |
Total accured expense and other current liabilities | $ 1,052 | $ 3,527 |
Balance Sheet Components (Additional Information) (Details) - USD ($) $ in Thousands |
3 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|
May 31, 2023 |
Dec. 16, 2022 |
Mar. 31, 2023 |
Mar. 31, 2022 |
Dec. 31, 2022 |
|
Balance Sheet Components [Line Items] | |||||
Property and equipment, net | $ 72 | $ 249 | |||
Proceeds from disposal of assets | 175,000 | ||||
Proceeds From Sale Of Other Assets 1 | 285,000 | ||||
Depreciation and amortization expense | $ 2,000 | $ 16,000 | |||
Common stock, shares issued | 8,531,000 | 8,318,000 | |||
Proceeds From Issuance Of Common Stock | $ 752 | $ 98 | |||
Private Placement | |||||
Balance Sheet Components [Line Items] | |||||
Future Right Recorded as Other Asset | $ 2,300 | ||||
Sell and purchase of its common stock, description | With respect to the second closing, the Company is obligated to sell and issue a number of shares of its common stock and the investors are obligated to buy such shares by the specified date and price equal to the volume-weighted average price of Company common stock for the five trading days prior to July 25, 2023 (“VWAP”) plus 10% of the VWAP. | ||||
Common stock, shares issued | 649,346 | ||||
Proceeds From Issuance Of Common Stock | $ 7,400 | ||||
Private Placement | Forecast [Member] | |||||
Balance Sheet Components [Line Items] | |||||
aggregate purchase price | $ 22,500 | ||||
Future Right Recorded as Other Asset | $ 2,300 | ||||
Equipment | |||||
Balance Sheet Components [Line Items] | |||||
Property and equipment, net | $ 100 | $ 100 |
Notes Payable - Schedule of Notes Payable (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Debt Instrument [Line Items] | ||
Total notes payable | $ 779 | $ 779 |
Fair Value | 754 | 748 |
Less: current portion | 0 | |
Notes payable, net of current portion | 754 | 748 |
2020 Notes Payable | ||
Debt Instrument [Line Items] | ||
Total notes payable | 250 | 250 |
Fair Value | 225 | 219 |
Other Notes Payable | ||
Debt Instrument [Line Items] | ||
Total notes payable | 379 | 379 |
Fair Value | 379 | 379 |
Small Business Administration Loan | ||
Debt Instrument [Line Items] | ||
Total notes payable | 150 | 150 |
Fair Value | $ 150 | $ 150 |
Notes Payable - Schedule of Expected Future Minimum Principal (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Debt Instruments [Abstract] | ||
2023 | $ 0 | |
2024 | 629 | |
2025 | 0 | |
2026 | 0 | |
2027 | 2 | |
Thereafter | 148 | |
Total notes payable | 779 | |
Less: current portion | 0 | |
Notes payable, net of current portion | $ 779 | $ 779 |
Commitments and Contingencies (Additional Information) (Details) |
3 Months Ended | ||||||
---|---|---|---|---|---|---|---|
Mar. 31, 2023
USD ($)
|
Mar. 31, 2022
USD ($)
|
Sep. 20, 2022
USD ($)
|
Jun. 30, 2020
ft²
|
May 31, 2020
ft²
|
Jan. 31, 2019
ft²
|
Dec. 31, 2017
ft²
|
|
Lease Agreement [Member] | |||||||
Long-Term Purchase Commitment [Line Items] | |||||||
Lessee, Operating Lease, Option to Extend | contains two five-year options to extend the lease term. | ||||||
Area of land | ft² | 14,870 | 22,064 | |||||
Lease Expiration Date | Jul. 31, 2024 | ||||||
Payments for rent | $ 237,000 | $ 208,000 | |||||
Variable lease, cost | $ 172,000 | 137,000 | |||||
Accrued Compensation | $ 1,300,000 | ||||||
Sublease Agreement [Member] | |||||||
Long-Term Purchase Commitment [Line Items] | |||||||
Area of land | ft² | 7,194 | 1,850 | |||||
Lease term extend, description | In October 2020 the sublease expiration date was extended from December 2020 to December 2022. | ||||||
Sublease income | $ 49,000,000 | $ 46,000,000 | |||||
Proceeds from rent | $ 120,000 |
Commitments and Contingencies - Schedule of Operating Lease Future Undiscounted Payments (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Operating Lease [Abstract] | ||
Remainder of 2023 | $ 705 | |
2024 | 561 | |
Total undiscounted lease payments | 1,266 | |
Less: Imputed interest | (76) | |
Operating lease liability | 1,190 | |
Less: Operating lease liability, current portion | (871) | $ (843) |
Operating lease liability, net of current portion | $ 319 | $ 547 |
Commitments and Contingencies - Schedule of Operating Leases Supplemental Information (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Operating Lease: | ||
Cash paid for operating lease agreement (in thousands) | $ 231 | $ 224 |
Remaining lease term (in years) | 1 year 3 months 18 days | 2 years 3 months 18 days |
Incremental borrowing rate | 10.00% | 10.00% |
Commitments and Contingencies - Schedule of Finance Lease Future Undiscounted Payments (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Finance Lease [Abstract] | ||
Remainder of 2023 | $ 37 | |
2024 | 50 | |
2025 | 32 | |
2026 | 10 | |
Total undiscounted lease payments | 129 | |
Less: Imputed interest | (15) | |
Financing lease liabilities | 114 | |
Less: Financing lease liabilities, current portion | (41) | $ (40) |
Finance lease liabilities, net of current portion | $ 73 | $ 83 |
Commitments and Contingencies - Schedule of Finance Leases Supplemental Information (Details) |
Mar. 31, 2023 |
Mar. 31, 2022 |
---|---|---|
Finance Leases: | ||
Weighted average remaining lease term (in years) | 2 years 8 months 12 days | 3 years 2 months 12 days |
Incremental borrowing rate | 9.30% | 9.30% |
Strategic License Agreements - Additional Information (Details) - USD ($) $ in Thousands |
3 Months Ended | 44 Months Ended | |||
---|---|---|---|---|---|
Jun. 09, 2021 |
Aug. 10, 2020 |
Mar. 31, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
|
License Agreements Disclosure [Line Items] | |||||
Aggregate fair market value | $ 9 | $ 9 | $ 8 | ||
Number of shares issued | 8,531,000 | 8,531,000 | 8,318,000 | ||
Milestones achieved | $ 0 | ||||
Royalties due | $ 0 | ||||
Option and License Agreement | Gigagen, Inc | |||||
License Agreements Disclosure [Line Items] | |||||
Payments for option and license agreement | $ 200 | ||||
Upfront option exercise fee | $ 400 | 400 | |||
Development and regulatory milestones, aggregate amount payable | 20,000 | 20,300 | |||
Sales milestone, aggregate amount payable | 8,000 | 8,000 | |||
Milestone expenses | $ 250 | ||||
Royalties due | $ 0 | ||||
Option and License Agreement | Gigagen, Inc | Non-voting Common Stock | |||||
License Agreements Disclosure [Line Items] | |||||
Aggregate fair market value | $ 250 | $ 250 |
Collaboration Agreement - Summary of collaboration revenue agreement and deferred revenue (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Revenue Recognition And Deferred Revenue [Abstract] | ||
Balance as of beginning of period | $ 442 | |
Decrease for provision of researchs services | (281) | |
Balance as of end of period | $ 161 |
Collaboration Agreement (Additional Information) (Details) - USD ($) |
3 Months Ended | |||
---|---|---|---|---|
Mar. 31, 2023 |
Dec. 31, 2022 |
Mar. 31, 2022 |
Dec. 31, 2021 |
|
Deferred Revenue Arrangement [Line Items] | ||||
Deferred revenue | $ 161,000 | $ 442,000 | ||
Merck Co Inc [Member] | ||||
Deferred Revenue Arrangement [Line Items] | ||||
Deferred revenue | 161,000 | $ 442,000 | ||
Revenue | $ 281,000 |
Grant Agreements - Additional Information (Details) - USD ($) |
3 Months Ended | 12 Months Ended | |
---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Dec. 31, 2022 |
|
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Recognized grant revenue from federal agencies | $ 0 | $ 75,000 | |
National Institutes Of Health | Grant revenues [Member] | |||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||
Grant Received for Research And Development | $ 1,100,000 |
Licensing Revenue Agreement - Summary Of Licensing Revenue Agreements (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Revenue Recognition And Deferred Revenue [Abstract] | ||
Balance as of December 31, 2022 | $ 0 | $ 1,041 |
Decrease for provision of research services | 0 | (358) |
Balance as of March 31, 2023 | $ 0 | $ 683 |
Licensing Revenue Agreement - Additional Information (Details) - USD ($) |
3 Months Ended | |||
---|---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
|
Deferred Revenue Arrangement [Line Items] | ||||
Deferred revenue | $ 161,000 | $ 442,000 | ||
Genentech,Inc. | ||||
Deferred Revenue Arrangement [Line Items] | ||||
Deferred revenue | 0 | |||
Genentech,Inc. | License And Research Collaboration Agreement | ||||
Deferred Revenue Arrangement [Line Items] | ||||
License revenue recognized | $ 0 | $ 358,000 |
Stock-Based Compensation - Summary of Fair Value of Stock Options Granted for Employee and Non-Employee Awards (Details) |
3 Months Ended |
---|---|
Mar. 31, 2022 | |
Minimum | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Expected volatility | 84.20% |
Expected term (years) | 5 years 9 months 18 days |
Risk-free interest rate | 1.60% |
Expected dividend yield | 0.00% |
Maximum | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Expected volatility | 84.70% |
Expected term (years) | 6 years 7 months 6 days |
Risk-free interest rate | 2.20% |
Expected dividend yield | 0.00% |
Stock-Based Compensation - Summary of Companies Restricted Stock Activity (Detail) |
3 Months Ended |
---|---|
Mar. 31, 2023
$ / shares
shares
| |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Number of Restricted Stock, Beginning Balance | shares | 175,000 |
Number of Restricted Stock, Released | shares | (23,000) |
Number of Restricted Stock, ending Balance | shares | 152,000 |
Weighted-Average Grant Date Fair Value Per Share, Beginning Balance | $ / shares | $ 26.89 |
Weighted-Average Grant Date Fair Value Per Share, Released | $ / shares | 27.03 |
Weighted-Average Grant Date Fair Value Per Share, Ending Balance | $ / shares | $ 26.87 |
Stock-Based Compensation - Summary of Total Stock-Based Compensation (Detail) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | $ 1,054 | $ 285 |
Research and development [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | 77 | 165 |
General and administrative [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | $ 977 | $ 120 |
Net Loss Per Share - Summary of Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Numerator: | ||
Net loss attributable to Kineta, Inc. | $ (6,451) | $ (4,976) |
Denominator: | ||
Weighted-average shares outstanding, basic | 8,361,000 | 4,663,000 |
Weighted-average shares outstanding, diluted | 8,361,000 | 4,663,000 |
Net loss per share, basic | $ (0.77) | $ (1.07) |
Net loss per share, diluted | $ (0.77) | $ (1.07) |
Net Loss Per Share - Summary of Basic and Diluted Net Loss per Share (Parenthetical) (Details) - Common Stock [Member] - $ / shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Weighted Average Number of Shares, Contingently Issuable | 520,000 | 234,000 |
Share price | $ 0.14 |
Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Diluted Weighted-average Shares Outstanding (Detail) - shares shares in Thousands |
3 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2023 |
Dec. 31, 2022 |
|
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 1,398 | 1,497 |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 708 | 733 |
Unvested Restricted Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 152 | 175 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 482 | 533 |
Vested Restricted Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 56 | 56 |
Net Loss Per Share (Additional Information) (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Earnings Per Share [Abstract] | ||
Defined contribution plan | $ 40,000 | $ 41,000 |
Related Party Transactions - Additional Information (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Related Party Transaction [Line Items] | ||
Cash payment of creditors | $ 4,000,000.0 | |
Gain on extinguishments of debt, net | $ 0 | $ 669,000 |
Executive management | ||
Related Party Transaction [Line Items] | ||
Number of shares issued | 19,000 | |
Directors | ||
Related Party Transaction [Line Items] | ||
Number of shares issued | 2,000 | |
Common Stock [Member] | ||
Related Party Transaction [Line Items] | ||
Conversion Price | $ 0.14 | |
Number of shares issued | 23,000 |
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