10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025

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 001-37695

 

KINETA, INC.

(Exact name of Registrant as specified in its Charter)

 

Delaware

20-8436652

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

7683 SE 27th Street, Suite 481

Mercer Island, WA

98040

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (206) 378-0400

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

KANT

 

OTC Pink Market

 

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. Yes No

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). Yes No

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

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

The number of shares of Registrant’s Common Stock outstanding as of May 12, 2025 was 13,540,355.

 

 

 

 

 


 

Table of Contents

 

Page

 

Special Note Regarding Forward-Looking Statements

1

PART I

FINANCIAL INFORMATION

3

 

 

 

Item 1.

Financial Statements (Unaudited)

3

 

Condensed Consolidated Balance Sheets

3

 

Condensed Consolidated Statements of Operations

4

 

Condensed Consolidated Statements of Shareholders' Equity (Deficit)

5

 

Condensed Consolidated Statements of Cash Flows

6

 

Notes to Unaudited Condensed Consolidated Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

Item 4.

Controls and Procedures

28

 

PART II

OTHER INFORMATION

30

 

 

 

Item 1.

Legal Proceedings

30

Item 1A.

Risk Factors

30

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

30

Item 3.

Defaults Upon Senior Securities

30

Item 4.

Mine Safety Disclosures

30

Item 5.

Other Information

30

Item 6.

Exhibits

32

Signatures

 

33

 

 

 

 

i


 

CAUTIONARY STATEMENT

In February 2024, the Company initiated a process to explore a range of strategic alternatives to maximize shareholder value. Potential strategic alternatives that may be evaluated include sale of assets of the Company, a sale of the Company, licensing of assets, a merger, liquidation or other strategic action. The outcome of this process was the proposed merger transaction with TuHURA and sale of the Company’s assets described elsewhere in this Quarterly Report on Form 10-Q. If the transaction with TuHURA is not consummated, the Company’s Board of Directors may decide to pursue a liquidation or obtain relief under the US Bankruptcy Code.

Kineta, Inc. cautions that trading in the Company’s securities is highly speculative and poses substantial risks. Trading prices for the Company’s securities may bear little or no relationship to the actual value realized, if any, by holders of the Company’s securities. Accordingly, the Company urges extreme caution with respect to existing and future investments in its securities.

 

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:

the completion of the proposed merger with TuHURA Biosciences, Inc.;
plans and expectations for the outcome of strategic alternatives, expectations regarding our strategic alternative review process, and the timing and success of such process regarding a potential transaction;
beliefs about our available options and financial condition;
our ability to fund our planned operations for the next twelve months and our ability to continue as a going concern;
expectations that our cash will be sufficient to fund our operating expenses into the future;
estimates for our expenses and capital requirements;
the timing, progress and results of preclinical studies and clinical trials for our programs and product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
our ability to recruit and enroll suitable patients in our clinical trials;
the potential attributes and benefits of our product candidates;
our ability to develop and advance product candidates into, and successfully complete, clinical studies;
the timing, scope or likelihood of regulatory filings and approvals;
our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings in the label of an approved product candidate;
the implementation of our business model and our strategic plans for our business, product candidates, technology and our discovery engine;
our commercialization, marketing and manufacturing capabilities and strategy;
the pricing and reimbursement of our product candidates, if approved;
the rate and degree of market acceptance of our product candidates, if approved;
our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;
our ability to contract with and rely on third parties to assist in conducting our clinical trials and manufacturing our product candidates;
the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others;

 

1


 

our ability to obtain funding for our operations, including funding necessary to complete further development, approval and, if approved, commercialization of our product candidates;
the period over which we anticipate our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements;
the potential for our business development efforts to maximize the potential value of our portfolio;
our ability to compete with other companies currently marketing or engaged in the development of treatments for the indications that we are pursuing for our product candidates;
our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;
our financial performance;
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
any statements of the plans, strategies and objectives of management for future operations, including the execution of integration plans and the anticipated timing of filings;
our expectations related to the use of our cash reserves;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our ability to remediate the material weaknesses in our internal control over financial reporting;
the impact of laws and regulations, including without limitation recently enacted tax reform legislation;
the impact of global economic and political developments on our business, including tariffs and trade tensions, rising inflation and capital market disruptions, the current conflict in Ukraine and the conflict in Israel and the Gaza Strip, economic sanctions and economic slowdowns or recessions that may result from such developments, which could harm our research and development efforts as well as the value of our common stock and our ability to access capital markets; and
other risks and uncertainties, including those listed under the caption “Risk Factors” in Part II, Item 1A.

 

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.

 

Additional Information

 

Unless the context otherwise requires, references to the “Company,” “Kineta,” “we,” “our” or “us” in this Quarterly Report on Form 10-Q refer to Kineta, Inc. and its subsidiaries.

 

 

2


 

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

KINETA, INC.

Condensed Consolidated Balance Sheets

(in thousands)

(Unaudited)

 

 

 

March 31,

 

 

December 31,

 

 

 

2025

 

 

2024

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash

 

$

304

 

 

$

634

 

Restricted cash

 

 

4

 

 

 

4

 

Prepaid expenses and other current assets

 

 

534

 

 

 

381

 

Total current assets

 

 

842

 

 

 

1,019

 

Total assets

 

$

842

 

 

$

1,019

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,886

 

 

$

3,901

 

Accrued expenses and other current liabilities

 

 

1,413

 

 

 

2,361

 

Exclusivity Payments and advances

 

 

6,005

 

 

 

5,995

 

Notes payable, current portion

 

 

629

 

 

 

629

 

Loan advances

 

 

1,102

 

 

 

 

Total current liabilities

 

 

14,035

 

 

 

12,886

 

Total liabilities

 

 

14,035

 

 

 

12,886

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Stockholders’ Deficit:

 

 

 

 

 

 

Common stock, $0.001 par value; 125,000 shares authorized as of March 31, 2025 and December 31, 2024; 13,540 and 12,265 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

 

 

14

 

 

 

12

 

Additional paid-in capital

 

 

171,125

 

 

 

170,878

 

Accumulated deficit

 

 

(184,597

)

 

 

(182,921

)

Total stockholders’ deficit attributable to Kineta, Inc.

 

 

(13,458

)

 

 

(12,031

)

Noncontrolling interest

 

 

265

 

 

 

164

 

Total stockholders’ deficit

 

 

(13,193

)

 

 

(11,867

)

Total liabilities and stockholders’ deficit

 

$

842

 

 

$

1,019

 

 

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)

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

617

 

 

 

2,726

 

General and administrative

 

 

1,403

 

 

 

3,680

 

Total operating expenses

 

 

2,020

 

 

 

6,406

 

Loss from operations

 

 

(2,020

)

 

 

(6,406

)

Other (expense) income :

 

 

 

 

 

 

Gain on sale of assets

 

 

500

 

 

 

 

Interest income

 

 

 

 

 

48

 

Interest expense

 

 

(55

)

 

 

(42

)

Change in fair value of rights from Private Placement

 

 

 

 

 

(3,832

)

Other (expense) income, net

 

 

 

 

 

(17

)

Total other (expense) income, net

 

 

445

 

 

 

(3,843

)

Net loss

 

$

(1,575

)

 

$

(10,249

)

Net income (loss) attributable to noncontrolling interest

 

 

101

 

 

 

(11

)

Net loss attributable to Kineta, Inc.

 

$

(1,676

)

 

$

(10,238

)

Net loss per share, basic and diluted

 

$

(0.13

)

 

$

(0.87

)

Weighted-average shares outstanding, basic and diluted

 

 

12,902

 

 

 

11,738

 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

4


 

KINETA, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(in thousands)

(Unaudited)

 

 

 

Common Stock

 

 

Additional Paid-In Capital

 

 

Accumulated

 

 

Total Shareholders’ Equity (Deficit) Attributable

 

 

Noncontrolling

 

 

Total Shareholders’

 

 

 

Shares

 

 

Amount

 

 

Amount

 

 

Deficit

 

 

to Kineta

 

 

Interest

 

 

Equity (Deficit)

 

Balance as of December 31, 2023

 

 

10,397

 

 

$

10

 

 

$

168,669

 

 

$

(165,789

)

 

$

2,890

 

 

$

169

 

 

$

3,059

 

Issuance of common stock upon exercise of warrants

 

 

780

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

1

 

Issuance of common stock for services

 

 

173

 

 

 

 

 

 

469

 

 

 

 

 

 

469

 

 

 

 

 

 

469

 

Stock-based compensation

 

 

 

 

 

 

 

 

477

 

 

 

 

 

 

477

 

 

 

 

 

 

477

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(10,238

)

 

 

(10,238

)

 

 

(11

)

 

 

(10,249

)

Balance as of March 31, 2024

 

 

11,350

 

 

$

11

 

 

$

169,615

 

 

$

(176,027

)

 

$

(6,401

)

 

$

158

 

 

$

(6,243

)

 

 

 

 

Common Stock

 

 

Additional Paid-In Capital

 

 

Accumulated

 

 

Total Stockholders’ Deficit Attributable

 

 

Noncontrolling

 

 

Total Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Amount

 

 

Deficit

 

 

to Kineta

 

 

Interest

 

 

Deficit

 

Balance as of December 31, 2024

 

 

12,265

 

 

$

12

 

 

$

170,878

 

 

$

(182,921

)

 

$

(12,031

)

 

$

164

 

 

$

(11,867

)

Issuance of common stock and pre-funded warrants

 

 

1,225

 

 

 

2

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

2

 

Issuance of common stock upon exercise of warrants

 

 

50

 

 

 

 

 

 

6

 

 

 

 

 

6

 

 

 

 

 

 

6

 

Stock-based compensation

 

 

 

 

 

 

 

 

241

 

 

 

 

 

241

 

 

 

 

 

 

241

 

Net loss

 

 

 

 

 

 

 

 

 

 

(1,676

)

 

 

(1,676

)

 

 

101

 

 

 

(1,575

)

Balance as of March 31, 2025

 

 

13,540

 

 

$

14

 

 

$

171,125

 

 

$

(184,597

)

 

$

(13,458

)

 

$

265

 

 

$

(13,193

)

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

5


 

KINETA, INC.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

Operating activities:

 

 

 

 

 

 

Net loss

 

$

(1,575

)

 

$

(10,249

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Change in fair value of rights from Private Placement

 

 

 

 

 

3,832

 

Change in fair value of notes payable

 

 

 

 

 

9

 

Non-cash stock-based compensation

 

 

241

 

 

 

477

 

Non-cash operating lease expense

 

 

 

 

 

199

 

Common stock issued for services

 

 

 

 

 

469

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(153

)

 

 

(193

)

Accounts payable

 

 

985

 

 

 

2,432

 

Accrued expenses and other current liabilities

 

 

(948

)

 

 

(759

)

Operating lease liability

 

 

 

 

 

(228

)

Deferred revenue

 

 

10

 

 

 

 

Net cash used in operating activities

 

 

(1,440

)

 

 

(4,011

)

Financing activities:

 

 

 

 

 

 

Proceeds from loan advances

 

 

1,102

 

 

 

 

Proceeds from issuance of common stock and pre-funded warrants

 

 

2

 

 

 

 

Proceeds from exercise of warrants

 

 

6

 

 

 

1

 

Net cash provided by financing activities

 

 

1,110

 

 

 

1

 

Net change in cash and restricted cash

 

 

(330

)

 

 

(4,010

)

Cash and restricted cash at beginning of year

 

 

638

 

 

 

5,858

 

Cash and restricted cash at end of year

 

$

308

 

 

$

1,848

 

Components of cash and restricted cash:

 

 

 

 

 

 

Cash

 

$

304

 

 

$

1,773

 

Restricted cash

 

 

4

 

 

 

75

 

Total cash and restricted cash

 

$

308

 

 

$

1,848

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

Cash paid for interest

 

$

23

 

 

$

5

 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

6


 

KINETA, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

1.
Organization and Liquidity

Description of Business

 

Kineta, Inc. (together with its subsidiaries, “Kineta” or the “Company”) is headquartered in Mercer Island, Washington.

 

The Company is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the mechanisms of cancer immune resistance. 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, 2025, the Company owned a majority interest of the outstanding issued equity of KCP.

Proposed Merger Transaction with TuHURA Biosciences, Inc.

 

On December 11, 2024, Kineta entered into an Agreement and Plan of Merger, which was amended by the First Amendment to the Agreement and Plan of Merger dated May 5, 2025 (as amended, the “Merger Agreement”) by and among TuHURA Biosciences, Inc., a Nevada corporation (“TuHURA”), Hura Merger Sub I, Inc., a Delaware corporation and a direct wholly-owned subsidiary of TuHURA (“Merger Sub I”), Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of TuHURA (“Merger Sub II,” and together with Merger Sub I, the “Merger Subs”), and Craig Philips, solely in his capacity as the representative, agent and attorney-in-fact of the stockholders of Kineta. Each capitalized term used herein but not otherwise defined has the meaning given to it in the Merger Agreement.

 

Pursuant to the terms of the Merger Agreement, among other things and subject to the terms and conditions set forth therein, Merger Sub I will (a) merge with and into the Company (the “First Merger”), with the Company being the surviving corporation of the First Merger, also known as the “Surviving Entity”; and (b) immediately following the First Merger and as part of the same overall transaction as the First Merger, the Surviving Entity will merge with and into Merger Sub II (the “Second Merger” and, together with the First Merger, the “Mergers” ), with Merger Sub II being the surviving company of the Second Merger, also known as the “Surviving Company.” The Mergers are intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.

 

Subject to the terms and conditions of the Merger Agreement, at the effective time of the First Merger (the “Effective Time”), each share (the “Share”) of Kineta’s common stock, par value $0.001 per share (“Kineta Common Stock”), issued and outstanding immediately prior to the Effective Time (other than (i) Shares held in treasury by Kineta or held directly by TuHURA or the Merger Subs, which Shares will be cancelled, or (ii) Shares that are held by any holder who is entitled to demand and properly demands appraisal of such Shares of pursuant to, and in compliance with, Section 262 of the General Corporation Law of the State of Delaware) will thereupon be converted automatically into and will thereafter represent the right to receive, without interest, (x) the number of validly issued, fully paid and non-assessable shares of common stock, $0.001 par value per share, of TuHURA (“TuHURA Common Stock”) (rounded down to the nearest whole share subject to the payment of any cash in lieu of fractional shares as set forth in the Merger Agreement) equal to (i) the Initial Per Share Stock Consideration plus (ii) the Delayed Per Share Stock Consideration, (y) plus an amount in cash equal to (i) the Per Share Cash Consideration plus (ii) the Disposed Asset Payment Right (collectively, the Initial Per Share Stock Consideration, the Delayed Per Share Stock Consideration, the Per Share Cash Consideration and the Disposed Asset Payment Right, the “Merger Consideration”).

 

“Initial Per Share Stock Consideration” means the number of shares of TuHURA Common Stock being issued for each share of Kineta Common Stock, determined as follows:

 

the difference of $16,500,000 and any deductions if the Per Share Cash Consideration (as described below) is less than zero;
such difference in the first bullet, divided by $5.7528, such stock price, the “Parent Share Value”; and
with such resulting quotient from the second bullet, divided by the fully diluted Kineta Common Stock, all rounded down to six (6) decimal places.

 

“Delayed Per Share Stock Consideration” means the number of shares of TuHURA Common Stock being issued for each share of Kineta Common Stock, determined as follows:

 

the difference of $6,500,000 and (i) any liabilities incurred by TuHURA due to a breach of the undisclosed liabilities representation made by Kineta in the Merger Agreement; (ii) any and all losses incurred through the six months after the closing of the Merger (the “Closing”) and those losses estimated to be incurred TuHURA related to any stockholder litigation; and (iii) any amount to which the closing net working capital deficient is greater than $6,000,000;
such difference in the first bullet, divided by the Parent Share Value; and

 

7


 

with such resulting quotient from the second bullet, divided by the fully diluted Kineta Common Stock, all rounded down to six (6) decimal places.

 

“Per Share Cash Consideration” means an amount in cash for each share of Kineta Common Stock, determined as follows:

 

the difference of $12,000,000 and (i) $5,000,000 (as credit for the exclusivity payment already made by TuHURA to Kineta); (ii) $300,000 (as credit for the extension payment already made by TuHURA to Kineta); (iii) $695,000 (which represents advances already made by TuHURA to Kineta in connection with the exclusivity agreement); (iv) any Loaned Amount, if any; and (v) if the net working capital is less than $0, such difference (and if the net working capital is greater than $0, then such difference will be added to the $12,000,000 base cash consideration); and
such difference in the first bullet, divided by the fully diluted Kineta Common Stock, all rounded down to six (6) decimal places.

 

“Loaned Amount” means all principal and interest outstanding under any loan between TuHURA, on the one hand, and Kineta, on the other hand, consisting of (i) $250,000 that was previously advanced by TuHURA to Kineta, (ii) $250,000 to be advanced by TuHURA to Kineta on or before May 15, 2025, and (iii) $250,000 to be advanced by TuHURA to Kineta on or before June 3, 2025 (with the advance in foregoing clause (iii) being contingent upon TuHURA’s receipt of (A) proceeds from the Concurrent Investment or (B) proceeds from TuHURA stockholder warrant exercise payments due on May 30, 2025), in each case, for any expenses incurred by Kineta in the ordinary course of business or expenses incurred in connection with the Program Assets and approved by TuHURA, and such amount shall be paid by TuHURA to Kineta no later than five (5) Business Days after the request is made (and invoice or proof of expense is provided to TuHURA) as long as no event of default has occurred and is continuing under the Merger Agreement as of the date of such request and so long as the parties thereto are then still working in good faith toward a Closing.

 

“Disposed Asset Payment Right” means any cash payments received by the Company in connection with any permitted asset disposition (which may not relate to the assets associated with, derived from or relating to KVA12123) received from the Closing Date until the third-year anniversary thereof, extended up to a period of six years in aggregate after the Closing Date.

 

“net working capital” means any cash Kineta has at the Closing, plus $322,933 for prepaid expenses in connection with their trials minus any liabilities of Kineta at the Closing and any unpaid transaction expenses of the Company.

 

At the Effective Time, each In-the-Money Company Stock Option that is vested or unvested and held by a Person will become exercisable as set forth in the applicable Optionholder Treatment Agreement and, upon such exercise, the holder will be entitled to receive the Merger Consideration; each Out-of-the-Money Company Stock Option held by a Person will be canceled and extinguished for no consideration; the Pre-2023 Company Warrants will terminate upon their terms if such Pre-2023 Company Warrants are not exercised (if the Pre-2023 Company Warrants are exercised prior to the Effective Time, as a holder of the Shares, the holder of such Pre-2023 Company Warrants will be entitled to receive the Merger Consideration); and the 2023 Company Warrants will be entitled to the benefits as set forth in the applicable Warrantholder Treatment Agreement.

 

The Closing is subject to satisfaction or waiver of certain conditions including, among other things, (i) the required approval of the Mergers by Kineta’s stockholders, (ii) the accuracy of the representations and warranties, subject to certain materiality qualifications, (iii) the effectiveness of the registration statement of TuHURA pursuant to which shares of TuHURA Common Stock to be issued in the Mergers will be registered with the SEC, (iv) compliance by the parties with their respective covenants, (v) no law or order preventing the Mergers and related transactions, (vi) the listing of shares of TuHURA Common Stock issued as Merger Consideration to Kineta stockholders on The Nasdaq Capital Market, (vii) the absence of a continuing material adverse effect with respect to each of TuHURA and Kineta, (viii) the completion by TuHURA of a financing transaction that will result in gross proceeds to TuHURA of not less than $20 million, (ix) the approval by TuHURA’s stockholders of an amendment to its articles of incorporation increasing its authorized shares to 200,000,000 shares of TuHURA Common Stock and (x) Kineta having a maximum of $6,000,000 in estimated net working capital deficit at the Closing.

 

Going Concern and Capital Resources

The Company has incurred recurring net losses and negative cash flows from operations since inception and, as of March 31, 2025, had an accumulated deficit of $184.6 million. The net loss attributable to the Company was $1.7 million for the three months ended March 31, 2025. As of March 31, 2025, the Company had unrestricted cash of $304,000, and there is substantial doubt about its ability to continue as a going concern. Based on Kineta’s current operating plans, Kineta does not have sufficient cash and cash equivalents to fund its operating expenses and capital expenditures for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

 

Kineta is exploring strategic alternatives that may include, but are not limited to, sale of assets of the Company, a sale of the Company, licensing of assets, a merger, liquidation or other strategic action.

 

On July 3, 2024 (the “Effective Date”), the Company entered into an exclusivity and right of first offer agreement (the “Exclusivity Agreement”) by and between the Company and TuHURA.

 

Pursuant to the Exclusivity Agreement, among other things, Kineta has granted TuHURA an exclusive right to acquire Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123, the Company’s VISTA blocking immunotherapy, during the period

 

8


 

commencing as of the Effective Date and continuing through the first to occur of (a) the execution of any Definitive Agreement (as defined in the Exclusivity Agreement) with respect to a Potential Transaction (as defined in the Exclusivity Agreement) by TuHURA or one or more of its affiliates and (b) 11:59 PM Eastern Time on October 1, 2024, subject to extension as noted in the following sentence (the “Exclusivity Period”). In the event that the Parties are engaged in good faith discussions regarding a Potential Transaction on the date on which the Exclusivity Period (or any renewal thereof) is scheduled to expire and TuHURA has not yet closed the transactions contemplated by that previously announced agreement and plan of merger by and among TuHURA, Kintara Therapeutics, Inc. (“Kintara”) and Kayak Mergeco, Inc., a wholly-owned subsidiary of Kintara, then on such date, the Exclusivity Period shall automatically renew for an additional ten (10) day period (a “Renewal Period”) (up to a total of two (2) renewal periods for an aggregate of twenty (20) days).

 

In consideration for Kineta’s compliance with its obligations set forth in the Exclusivity Agreement, TuHURA paid to Kineta $5.0 million (the “Exclusivity Payment”) in July 2024. The Exclusivity Payment is included on the balance sheets. No later than two (2) business days after a Renewal Period has started (to be confirmed in writing by both Parties), TuHURA shall pay an additional $150,000 as an additional Exclusivity Payment, in an amount not to exceed $300,000 for the two (2) available Renewal Periods. The Exclusivity Payment will be credited against the initial cash consideration that may be payable to Kineta pursuant to any Definitive Agreement (if any) between Kineta and TuHURA and/or its affiliates with respect to a Potential Transaction. In October 2024, TuHURA exercised its right to extend the Exclusivity Agreement and paid the Company $300,000 in Exclusivity Payments.

 

Kineta may seek additional funds through equity or debt financings or through collaborations, licensing transactions or other sources that may be identified through the Company’s strategic process. However, there can be no assurance that Kineta will be able to complete any such transactions on acceptable terms or otherwise. The failure to obtain sufficient funds on commercially acceptable terms when needed would have a material adverse effect on Kineta’s business, results of operations, and financial condition. These factors raise substantial doubt about Kineta’s ability to continue as a going concern.

 

Kineta does not currently have any commitments for future funding or additional capital. The Company is pursuing litigation or seeking other settlements against certain investors for the failure to fund. Due to the lack of commitments for future funding or additional capital, Kineta has paused or significantly scaled back the development or commercialization of its future product candidates or other research and development initiatives. If Kineta is unable to complete a strategic transaction or raise additional capital in sufficient amounts, Kineta will not be able to continue its business and the Company may need to file for bankruptcy protection.

Political and Geopolitical Developments

Geopolitical developments, such as the current conflict in Ukraine and the conflict in Israel and the Gaza Strip 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.

 

Under the current U.S. administration, there is significant and increasing uncertainty about the future relationship between the United States, China, and other exporting countries, including with respect to trade policies, treaties, government regulations, and tariffs. On April 9, 2025, President Trump announced a pause to previously announced tariffs on most countries for 90 days. Countries subject to the pause on the tariffs are still to be subject to the baseline 10% tariff. Changes in laws or policies governing the terms of trade could have a material adverse effect on our business and financial results.

 

2.
Summary of Significant Accounting Policies

 

Unaudited Interim Financial Information

The unaudited condensed consolidated balance sheet as of December 31, 2024 was derived from the Companys 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, 2025 and for the three months ended March 31, 2025, 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, 2024, filed with the SEC on March 7, 2025 (the “2024 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, 2024 included in the 2024 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, 2025 and condensed consolidated results of operations and cash flows for the three months ended March 31, 2025 and 2024 have been made. The results of

 

9


 

operations for the three months ended March 31, 2025 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025.

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. The condensed consolidated financial statements include all accounts of the Company and its majority owned subsidiary KCP. 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.

 

Segment Reporting

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker (the “CODM”), or decision-making group, in making decisions on how to allocate resources and assess performance. Reportable segments are categorized based on various factors that help management assess and allocate resources effectively. The Company operates as a single reportable segment, as the CODM, the Company's President, evaluates the financial performance and allocates resources based on consolidated financial information.

 

Net income (loss) per share

Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of Kineta Common Stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding common share equivalents. For the three months ended March 31, 2025 and the three months ended March 31, 2024, the Company reported a net loss and the diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

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.

 

Rights from Private Placement

 

The Company determined that the rights from Private Placement was a derivative asset, which required the asset to be accounted for at fair value. The second closing of the Private Placement did not occur during 2024 and as a result, the Company deemed the fair value of the rights from Private

Placement to be zero and was written off as of December 31, 2024.

The following table provides a summary of the changes in the fair value of the rights from Private Placement measured using Level 3 inputs:

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

 

(in thousands)

 

Balance at beginning of period

 

$

 

 

$

3,832

 

Change in fair value of rights from Private Placement

 

 

 

 

 

 

Balance at end of period

 

$

 

 

$

3,832

 

 

2020 Notes

 

The Company elected the fair value option to account for the 2020 notes (as defined below) (see Note 5).

During 2024 and 2025, the Company did not obtain an independent valuation of the 2020 notes as they matured on July 31, 2024 and the fair value approximates the principal amount. The 2020 notes matured on July 31, 2024 and are payable any time after the maturity date upon demand by a majority of the holders.

 

10


 

The following table provides a summary of the changes in the fair value of the 2020 notes payable measured using Level 3 inputs:

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

 

(in thousands)

 

Balance at beginning of period

 

$

250

 

 

$

241

 

Change in fair value of 2020 notes

 

 

 

 

 

 

Balance at end of period

 

$

250

 

 

$

241

 

 

 

4.
Balance Sheet Components

Property and Equipment, Net

There was no property and equipment as of March 31, 2025 or December 31, 2024.

Depreciation and amortization expense was zero for the three months ended March 31, 2025 and 2024.

 

Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following as of the periods presented:

 

 

 

March 31,

 

 

December 31,

 

 

 

2025

 

 

2024

 

 

 

(in thousands)

 

Compensation and benefits

 

$

796

 

 

$

696

 

Accrued interest

 

 

282

 

 

 

228

 

Accrued board fees

 

 

194

 

 

 

97

 

Professional services

 

 

93

 

 

 

1,238

 

Accrued clinical trial and preclinical costs

 

 

 

 

 

80

 

Other

 

 

48

 

 

 

22

 

Total accrued expenses and other current liabilities

 

$

1,413

 

 

$

2,361

 

 

5.
Notes Payable

Notes payable outstanding consisted of the following as of the periods presented:

 

 

 

March 31, 2025

 

 

December 31, 2024

 

 

 

Principal

 

 

Fair Value

 

 

Principal

 

 

Fair Value

 

 

 

(in thousands)

 

Notes payable:

 

 

 

 

 

 

 

 

 

 

 

 

2020 notes

 

$

250

 

 

$

250

 

 

$

250

 

 

$

250

 

Other notes payable

 

 

379

 

 

 

379

 

 

 

379

 

 

 

379

 

Total notes payable

 

$

629

 

 

 

629

 

 

$

629

 

 

 

629

 

Less: current portion

 

 

 

 

 

629

 

 

 

 

 

 

629

 

Notes payable, net of current portion

 

 

 

 

$

 

 

 

 

 

$

 

 

The Company elected the fair value option for the 2020 notes (see Note 3). The other notes payable approximate their fair value because interest rates are at prevailing market rates.

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. 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.

 

 

11


 

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. As the 2020 notes were valued pursuant to the fair value election, an immaterial gain was recognized upon extinguishment. The 2020 notes matured on July 31, 2024 and are payable anytime after the maturity date upon demand by the holder.

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 $379,000 to June 30, 2024 and decreased the interest rate to 6.0% interest, which was accounted for as a modification. As the other notes payable approximated their fair value, no gain or loss was recognized upon extinguishment. The other notes payable matured on June 30, 2024 and are payable anytime after the maturity date upon demand by the holder.

6.
Commitments and Contingencies

Leases

Operating Lease

 

The Company leased office and laboratory premises in Seattle, Washington pursuant to a lease agreement that commenced in April 2011 and expired on July 31, 2024. This lease was not extended and no other facility lease was entered into as the Company's employees work remotely. The agreement, which required monthly lease payments, was subject to annual rent escalations during the lease term, and contained 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 was required to pay certain operating costs, in addition to rent, such as common area maintenance, taxes and utilities. Such additional charges are considered variable lease costs and are recognized in the period in which they are incurred. Rent expense was zero for the three months ended March 31, 2025 and variable costs were zero. Rent expense was $208,000 for the three months ended March 31, 2024 and variable costs were $151,000.

 

The Company’s operating leases included various covenants, indemnities, defaults, termination rights, security deposits and other provisions customary for lease transactions of this nature.

 

Supplemental information on the Company’s operating leases was as follows:

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

Cash paid for operating lease agreement (in thousands)

 

$

 

 

$

238

 

Remaining lease term (in years)

 

 

-

 

 

 

0.3

 

Incremental borrowing rate

 

 

0

%

 

 

10

%

 

The Company subleased portions of its premises in Seattle, Washington to third parties. Under the first sublease agreement, which commenced in December 2017, the Company subleased 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. In December 2023, the sublease expiration date was extended from December 2023 to July 2024. Sublease income is recorded within operating expenses and was zero for the three months ended March 31, 2025 and $49,000 for the three months ended March 31, 2024.

 

On September 13, 2024 (the “Agreement Effective Date”), the Company entered into a Settlement Agreement, which was amended on February 4, 2025 (as amended, the “Agreement”) with ARE-SEATTLE No. 17, LLC (the “Landlord”), the landlord of the Company’s former premises in Seattle, Washington. Under the terms of the Agreement, the Company has agreed to pay the Landlord the outstanding monetary obligation of $679,000 (the “Outstanding Debt”) pursuant to that certain Lease Agreement, by and between the Company and the Landlord, dated as of November 19, 2010, as amended through June 30, 2020 (collectively, the “Lease”) as follows: (i) the Landlord’s application of the security deposit in the amount of $70,000, (ii) the Company’s payment to the Landlord of $85,000 (the “First Payment”) no later than five (5) business days after the Agreement Effective Date, and (iii) the Company’s payment to the Landlord of the Outstanding Debt balance of $524,000 (the “Second Payment” and together with the First Payment, the “Payment Milestones”) no later than May 31, 2025. The Agreement stipulates that upon the receipt by the Landlord of the Payment Milestones, the Landlord will fully discharge and forever release the Company from any claim, cause of action, or judgment, legal or equitable, in

 

12


 

contract or tort, direct or indirect, presently asserted or not, known or unknown, through the date of the Agreement related to the Company’s monetary obligations under the Lease. The Company paid the First Payment to the Landlord on September 18, 2024.

 

Additionally, under the Agreement, as consideration for the Landlord’s agreement to delay collection of the Outstanding Debt and to not assess additional interest and late fees with respect to the Outstanding Debt, the Company executed a Confession of Judgment (the “Confession”) in favor of the Landlord, and as consideration for the Company’s agreement to execute the Confession, the Landlord agreed not to file any lawsuit or other legal action against the Company related to the Outstanding Debt, or to otherwise cause the Confession to be entered into any legal action or proceeding unless the Company fails to satisfy the Payment Milestones. The Agreement specifies that except as it relates to the matters contemplated in the Agreement, no action by the parties is to be construed as an admission of liability by any party as it relates to such parties’ rights or obligations under the Lease.

 

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 and Separation 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 Yumanity Therapeutics, Inc. which closed on December 16, 2022 (the “Yumanity Merger”), with Shawn Iadonato, its former Chief Executive Officer, Craig Philips, its President, and Pauline Kenny, its former General Counsel. On April 23, 2023, the Company’s board of directors (the “Board”) approved salary increases effective at the next payroll period and bonus increases for fiscal year 2023 to Shawn Iadonato, Craig Philips, Keith Baker, and Pauline Kenny.

 

As part of the Company’s reduction in workforce plan, the Company terminated the employment of Shawn Iadonato and Pauline Kenny, each effective as of March 1, 2024, without cause. In connection with Dr. Iadonato’s departure, the Company entered into a separation and release agreement with Dr. Iadonato (the “Iadonato Separation Agreement”). Pursuant to the Iadonato Separation Agreement, Dr. Iadonato received payment equal to 80 hours of accrued but unused paid time off and two weeks worth of wages, which, in aggregate, is equal to $38,462. In exchange for the payments and other consideration under the Iadonato Separation Agreement, Dr. Iadonato provided the Company with a release, in favor of the Company, of any and all claims relating to his employment with the Company.

 

In connection with Dr. Iadonato’s departure, the Company also entered into a consulting agreement with Dr. Iadonato, effective as of March 1, 2024 (the “Iadonato Consulting Agreement”). Pursuant to the Iadonato Consulting Agreement, Dr. Iadonato will provide advisory services to the Company beyond December 31, 2024 (such period, the “Iadonato Consulting Period”). As consideration for Dr. Iadonato’s services under the Iadonato Consulting Agreement, Dr. Iadonato’s outstanding unvested equity awards shall continue to vest in accordance with the applicable purchase, award or grant agreement during the Iadonato Consulting Period. During the Iadonato Consulting Period through March 31, 2025, 142,000 shares of Dr. Iadonato’s outstanding unvested equity awards have vested and $576,000 is owed to Dr. Iadonato.

 

In connection with Ms. Kenny’s departure, the Company entered into a separation and release agreement with Ms. Kenny (the “Kenny Separation Agreement”). Pursuant to the Kenny Separation Agreement, Ms. Kenny received payment equal to 80 hours of accrued but unused paid time off and two weeks worth of wages, which, in aggregate, is equal to $25,000. In exchange for the payments and other consideration under the Kenny Separation Agreement, Ms. Kenny provided the Company with a release, in favor of the Company, of any and all claims relating to her employment with the Company.

 

In connection with Ms. Kenny’s departure, the Company also entered into a consulting agreement with Ms. Kenny, effective as of March 1, 2024 (the “Kenny Consulting Agreement”). Pursuant to the Kenny Consulting Agreement, Ms. Kenny will provide legal advisory services to the Company beyond December 31, 2024 (such period, the “Kenny Consulting Period”). As consideration for Ms. Kenny’s services under the Kenny Consulting Agreement, Ms. Kenny’s outstanding unvested equity awards shall continue to vest in accordance with the applicable purchase, award or

 

13


 

grant agreement during the Kenny Consulting Period. During the Kenny Consulting Period through March 31, 2025, 33,000 shares of Ms. Kenny’s outstanding unvested equity awards have vested and $304,000 is owed to Ms. Kenny.

The Executive Employment Agreements referenced above 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 (currently estimated at approximately $563,000 for the remaining two executives in the aggregate), (iii) nine (9) months of COBRA benefits 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.

7.
Strategic License Agreements

Anti-VISTA Antibody Program In-License Agreement

 

In August 2020, Kineta entered into an Option and License Agreement with GigaGen, Inc. (“GigaGen”), which was amended in November 2020 and further amended in May 2023 and January 2025 (such agreement, as amended, the “VISTA Agreement”) to in-license certain intellectual property and antibodies for the VISTA/KVA12123 drug program. Pursuant to the terms of the VISTA Agreement, GigaGen granted Kineta an exclusive (even as to GigaGen) world-wide license, with the right to grant sublicenses to research, develop, make, have made, use, have used, offer for sale, sell, have sold, distribute, import, have imported, export and have exported and otherwise exploit the licensed antibodies and licensed products. The Company did not incur any licensing expenses for the VISTA Agreement for the three months ended March 31, 2025 and 2024.

 

Under the VISTA Agreement, GigaGen is eligible to receive approximately $20.3 million in development and regulatory milestone payments and up to $11.0 million in sales milestone payments. In addition, GigaGen is eligible to receive low single-digit royalty percentages based on net sales. Kineta is responsible (with input from GigaGen) for the preparation, filing, prosecution and maintenance of all patents and patent applications, and all associated costs.

 

The VISTA Agreement shall remain in effect on a licensed product-by-licensed product and country-by-country basis, until the expiration of the royalty term for a licensed product in a country, which, based on the expiration of the last-to-expire valid claim of the two current patent applications (without any patent term adjustment or extensions) would be February 2042 and March 2044, respectively. Kineta may terminate the VISTA Agreement with 30 days’ written notice to GigaGen. Either party has the right to terminate the VISTA Agreement upon a material breach of the other party that is not cured within 90 days after the breaching party receives written notice of such breach from the non-breaching party.

Anti-CD27 Agonist Antibody Program In-License Agreement

 

In June 2021, Kineta entered into an Option and License Agreement with GigaGen, as amended in July 2022, December 2022, May 2023 and December 2023 (such agreement, as amended, the “CD27 Agreement”) to in-license certain intellectual property rights and antibodies for the CD27 drug program. Pursuant to the terms of the CD27 Agreement, GigaGen granted Kineta an exclusive (even as to GigaGen) world-wide license, with the right to grant sublicenses to research, develop, make, have made, use, have used, offer for sale, sell, have sold, distribute, import, have imported, export and have exported and otherwise exploit the licensed antibodies and licensed products. License expenses for the CD27 Agreement were a credit of $180,000 for the three months ended March 31, 2025 and $430,000 for the three months ended March 31, 2024.

 

GigaGen and Kineta entered into a Termination and Mutual Release Agreement, effective January 29, 2025, to terminate their existing CD27 Agreement. The termination is mutually agreed upon and is not due to any fault or breach by either party. GigaGen waived all accrued fees amounting to $180,000 and any future payments from Kineta. Kineta assigned all rights to its sole and joint inventions and patents related to the CD27 program back to GigaGen and transferred all related data and regulatory filings. Both parties released each other from any claims related to the CD27 Agreement and agreed to maintain confidentiality and cooperate in perfecting the transfer of intellectual property.

 

The Merck Neuromuscular License Agreement, Genentech Small Molecule License Agreement and FAIR License Agreement described below were sold to HCRX Investments Holdco, L.P. (“HCRX”) pursuant to the asset purchase agreement dated February 4, 2025 by and between Kineta and HCRX (the “HCRX Agreement”).

 

 

Merck Neuromuscular License Agreement

 

In connection with the Yumanity Merger, the Company became the successor in interest to the Merck Neuromuscular License Agreement with Merck to support research, development and commercialization of products for treatment of neuromuscular diseases, including amyotrophic lateral sclerosis. In June 2023, the Company achieved a development milestone pursuant to the Merck Neuromuscular License Agreement, which triggered a $5.0 million payment. Merck will continue to advance the research program for the ALS pipeline, one of the two pipeline programs licensed under the Merck Neuromuscular License Agreement. Following this milestone, Merck will assume sole responsibility for all future development and commercialization for the ALS program. The Company did not earn any licensing revenues for the three months ended March 31, 2025 and 2024 under the Merck Neuromuscular License Agreement and has no further obligations under the Merck Neuromuscular License Agreement.

 

Genentech

 

 

14


 

In connection with the Yumanity Merger, Kineta became the successor in interest to an exclusive technology transfer and license agreement with Genentech, Inc. to support research, development and commercialization of a small molecule product with an undisclosed target (the “Genentech Small Molecule License Agreement). The Company did not earn any revenues for the three months ended March 31, 2025 and 2024 under the Genentech Small Molecule License Agreement. Pursuant to the terms of the Genentech Small Molecule License Agreement, Genentech, Inc. provided notice of termination of agreement to Kineta on April 15, 2025. The termination will be effective thirty days from April 15, 2025.

 

 

FAIR Therapeutics

 

In connection with the Yumanity Merger, Kineta became the successor in interest to an exclusive license agreement with FAIR Therapeutics, B.V. to support research, development and commercialization of products for the treatment of cystic fibrosis (the “FAIR License Agreement”). The Company did not earn any revenues for the three months ended March 31, 2025 and 2024 under the FAIR License Agreement.

 

 

8.
Stockholders’ Equity

Common Stock

On March 7, 2025, the Company entered into a securities exchange agreement (the “Exchange Agreement”) with an existing investor (the “Holder”) pursuant to which the Company issued 1,225,323 shares of Kineta Common Stock and a pre-funded warrant to purchase up to an aggregate of 655,019 shares of Kineta Common Stock (the “Pre-Funded Warrant”), in exchange for certain outstanding warrants (the “Prior Warrant”) held by the Holder to purchase up to 2,315,387 shares of Kineta Common Stock with exercise prices ranging from $3.25 to $4.08 (the “Exchange”). The Company has cancelled the Prior Warrant reacquired in the exchange and such Prior Warrant will not be reissued.

As of March 31, 2025, there were 13,540,355 shares of Kineta Common Stock issued and outstanding.

 

Warrants to Purchase Common Stock

As of March 31, 2025, the Company had issued and outstanding warrants to purchase shares of Kineta Common Stock as follows, which all met the condition for equity classification (in thousands):

 

Year
Issued

 

Expiration
Date

 

Number Outstanding as of December 31, 2024

 

 

Issued

 

 

Exercised

 

 

Cancelled/Expired

 

 

Number Outstanding as of March 31, 2025

 

 

Range of
Exercise
Price

2017

 

June 2025

 

 

126

 

 

 

 

 

 

(32

)

 

 

(84

)

 

 

10

 

 

$0.14 - $21.80

2019

 

 

 

 

44

 

 

 

 

 

 

(18

)

 

 

(26

)

 

 

 

 

 

2022

 

August 2025 - December 2029

 

 

117

 

 

 

 

 

 

 

 

 

 

 

 

117

 

 

$0.14 - $168.35

2023

 

December 2025 - Oct 2028

 

 

2,431

 

 

 

 

 

 

 

 

 

(2,315

)

 

 

116

 

 

$0.14 - $5.26

2025

 

April 2025

 

 

 

 

 

655

 

 

 

 

 

 

 

 

 

655

 

 

$0.001

Total number of shares
   underlying warrants

 

 

 

 

2,718

 

 

 

655

 

 

 

(50

)

 

 

(2,425

)

 

 

898

 

 

 

 

Warrant Exercises

 

During the three months ended March 31, 2025, the Company issued 50,000 shares of Kineta Common Stock upon exercise of warrants and received proceeds of $6,000. The exercise price of all shares exercised during the three months ended March 31, 2025 was $0.14.

 

As of March 31, 2024, the Company had issued and outstanding warrants to purchase shares of Kineta Common Stock as follows, which all met the condition for equity classification (in thousands):

 

 

15


 

Year
Issued

 

Expiration
Date

 

Number Outstanding as of December 31, 2023

 

 

Issued

 

 

Exercised

 

 

Cancelled/Expired

 

 

Number Outstanding as of March 31, 2024

 

 

Range of
Exercise
Price

2017

 

March 2025 - June 2025

 

 

126

 

 

 

 

 

 

 

 

 

 

 

 

126

 

 

$0.14 - $21.80

2019

 

March 2025 - April 2027

 

 

44

 

 

 

 

 

 

 

 

 

 

 

 

44

 

 

$0.14 - $21.80

2022

 

August 2025 - December 2029

 

 

123

 

 

 

 

 

 

 

 

 

 

 

 

123

 

 

$0.14 - $168.35

2023

 

December 2025 - April 2029

 

 

3,211

 

 

 

 

 

 

(780

)

 

 

 

 

 

2,431

 

 

$3.25 - $5.26

Total number of shares underlying warrants

 

 

 

 

3,504

 

 

 

 

 

 

(780

)

 

 

 

 

 

2,724

 

 

 

During the three months ended March 31, 2024, the Company issued 780,000 shares of Kineta Common Stock upon exercise of warrants and received proceeds of $1,000. The exercise price of all shares exercised during the three months ended March 31, 2024 was $0.001.

Kineta Common Stock reserved for future issuance consisted of the following as the period presented:

 

 

 

March 31,
2025

 

 

 

(in thousands)

 

Shares reserved for stock options to purchase
   common stock under equity incentive plans

 

 

2,331

 

Shares reserved for future issuance of equity awards

 

 

766

 

Shares reserved for exercise of warrants

 

 

898

 

Total

 

 

3,995

 

 

During the three months ended March 31, 2025, the Company issued 50,000 shares of Kineta Common Stock upon exercise of warrants and received proceeds of $6,000. The exercise price of all shares exercised was $0.14.

During the three months ended March 31, 2024, the Company issued 780,000 shares of Kineta Common Stock upon exercise of warrants and received proceeds of $1,000. The exercise price of all shares exercised was $0.001.

During the three months ended March 31, 2024, the Company issued 91,000 shares of Kineta Common Stock for license expenses and recorded $250,000 as license expense within research and development expense.

During the three months ended March 31, 2024, the Company issued 82,000 shares of Kineta Common Stock for professional services and recorded $219,000 as consulting expense within general and administrative expense.

 

9.
Segment Reporting

 

The Company operates as a single reportable segment, which is primarily engaged in the development of next-generation immunotherapies. The Company has concluded that its President is the chief operating decision maker (“CODM”) for the three months ended March 31, 2025 and its former CEO and President together were the CODM for the three months ended March 31, 2024. The CODM reviews the Company’s performance and allocates resources on a consolidated basis. As a result, all financial information is disclosed in accordance with ASC 280-10 for a single reportable segment.

 

Basis of Presentation

 

The accounting policies of the segment are the same as those described in the summary of significant accounting policies. Segment information is prepared on the same basis that the CODM uses for internal management reporting.

 

 

Segment Information

 

The following table presents information about the Company’s segment:

 

 

16


 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

 

(in thousands)

 

Revenue

 

$

 

 

$

 

Operating Loss

 

$

(2,020

)

 

$

(6,406

)

Segment Assets

 

$

842

 

 

$

2,433

 

Capital Expenditures

 

$

 

 

$

 

Depreciation and Amortization

 

$

 

 

$

 

 

 

Significant Expenses:

 

The following table presents the Company’s significant operating expenses:

 

 

 

Three Months Ended March 31, 2025

 

 

 

Three Months Ended March 31, 2024

 

 

 

Research and Development

 

 

General and Administrative

 

 

Total

 

 

 

Research and Development

 

 

General and Administrative

 

 

Total

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Personnel

 

$

188

 

 

$

566

 

 

$

754

 

 

 

$

349

 

 

$

1,238

 

 

$

1,587

 

Facilities

 

 

 

 

 

 

 

 

 

 

 

 

40

 

 

 

286

 

 

 

326

 

Professional Services

 

 

5

 

 

 

525

 

 

 

530

 

 

 

 

 

 

 

1,768

 

 

 

1,768

 

Travel

 

 

 

 

 

 

 

 

 

 

 

 

27

 

 

 

51

 

 

 

78

 

Insurance and Other

 

 

14

 

 

 

268

 

 

 

282

 

 

 

 

9

 

 

 

265

 

 

 

274

 

Research and development - Direct

 

 

408

 

 

 

 

 

 

408

 

 

 

 

2,291

 

 

 

 

 

 

2,291

 

Office Expenses

 

 

2

 

 

 

44

 

 

 

46

 

 

 

 

10

 

 

 

73

 

 

 

83

 

Taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

(1

)

Total operating expenses

 

$

617

 

 

$

1,403

 

 

$

2,020

 

 

 

$

2,726

 

 

$

3,680

 

 

$

6,406

 

 

 

Entity-Wide Disclosures

 

In addition to the segment information, the Company provides entity-wide disclosures about its products and services, geographic areas, and major customers. The Company did not generate revenue for the three months ended March 31, 2025 and 2024.

 

The Company currently operates only in the United States and there were no long-lived assets outside of the United States as of March 31, 2025 and December 31, 2024.

 

10.
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 Kineta 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 86,000 stock options granted prior to the 2008 Plan expiration remain outstanding as of March 31, 2025.

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 Kineta 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 Kineta 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.

 

17


 

 

In February 2020, the 2010 Plan expired and 99,000 stock options granted prior to the expiration remain outstanding as of March 31, 2025.

 

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 Kineta 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 Kineta 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 181,000 stock options granted prior to the 2020 Plan expiration remain outstanding as of March 31, 2025.

 

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 Kineta 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 Kineta 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:

 

 

 

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, 2024

 

 

2,331

 

 

$

5.45

 

 

 

8.2

 

 

$

 

Granted

 

 

 

 

$

 

 

 

 

 

 

 

Exercised

 

 

 

 

$

 

 

 

 

 

 

 

Forfeited

 

 

 

 

$

 

 

 

 

 

 

 

Expired

 

 

 

 

$

 

 

 

 

 

 

 

Outstanding as of March 31, 2025

 

 

2,331

 

 

$

5.45

 

 

 

8.2

 

 

$

 

Exercisable as of March 31, 2025

 

 

1,389

 

 

$

8.26

 

 

 

7.4

 

 

$

 

 

 

Fair Value of Stock Options

 

The Company did not grant any stock options during the three months ended March 31, 2025 or 2024.

 

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,

 

 

 

2025

 

 

2024

 

 

 

(in thousands)

 

Research and development

 

$

64

 

 

$

74

 

General and administrative

 

 

177

 

 

 

403

 

Total stock-based compensation

 

$

241

 

 

$

477

 

 

 

18


 

As of March 31, 2025, there was $679,000 of unrecognized stock-based compensation related to stock options, which is expected to be recognized over a weighted-average remaining service period of 1.4 years.

11.
Net Loss Per Share

The following table summarizes the computation of basic and diluted net loss per share:

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

 

(in thousands, excepts per share amounts)

 

Numerator:

 

 

 

 

 

 

Net loss attributable to Kineta, Inc.

 

$

(1,676

)

 

$

(10,238

)

Denominator:

 

 

 

 

 

 

Weighted-average common shares outstanding, basic and diluted(1)

 

 

12,902

 

 

 

11,738

 

Net loss per share, basic and diluted

 

$

(0.13

)

 

$

(0.87

)

(1) Included in the denominator were 331,000 weighted-average shares of common stock warrants for the three months ended March 31, 2025, with a range of exercise prices of $.001 to $0.14. Included in the denominator were 663,000 weighted-average shares of common stock warrants for the three months ended March 31, 2024, with an exercise price of $0.14.

The following outstanding potentially dilutive Kineta 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:

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

(in thousands)

 

Warrants to purchase Kineta Common Stock

 

 

567

 

 

 

2,560

 

Common stock options

 

 

2,331

 

 

 

1,975

 

Vested restricted stock subject to recall

 

 

56

 

 

 

56

 

Unvested restricted stock subject to repurchase

 

 

-

 

 

 

8

 

Total

 

 

2,954

 

 

 

4,599

 

 

 

 

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 $3,000 for the three months ended March 31, 2025 and $23,000 for the three months ended March 31, 2024. The Company ceased making matching contributions during January 2025.

12.
Related Party Transactions

There were no related party transactions for the three months ended March 31, 2025 or 2024.

 

13.
Subsequent Events

The Company evaluated subsequent events through the date these consolidated financial statements were issued.

 

Clinical Trial Funding Agreement

 

Subsequent to March 31, 2025, pursuant to the Clinical Trial Funding Agreement, the Company received cash of $48,000 from TuHURA to reimburse the Company for clinical trial expenses related to KVA12123.

 

 

Philanthropos Asset Purchase Agreement

 

On May 12, 2025, Kineta entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Philanthropos Therapeutics, LLC (“Philanthropos”) pursuant to which Philanthropos agreed to acquire certain assets and properties of Kineta related to the development of LHF-535, a product candidate for the treatment of Lassa Fever. Under the terms of the Purchase Agreement, Philanthropos will acquire all right, title, and interest in the specified assets, including intellectual property, contracts, permits, inventory, tangible personal property, business records, warranties, and certain prepaid expenses, for an aggregate upfront purchase price of $50,000, of which $10,000 was received in March 2025 and the remaining

 

19


 

$40,000 was received in May 2025. In addition to the upfront payment, Kineta is entitled to receive revenue sharing payments during a six-year period following the later of the closing of the transactions contemplated by the Merger Agreement and the Effective Date, including (i) a 5% royalty on Net Product Sales derived from the Intellectual Property Rights, (ii) 5% of the net sales price of any Priority Review Voucher associated with the Intellectual Property Rights that is received and sold by Philanthropos, and (iii) 15% of gross Consideration received by Philanthropos from any sale or license of the Product or Seller Product, in whole or in part, associated with the Intellectual Property Rights.

 

 

 

 

20


 

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

 

On February 29, 2024, we announced that we had completed a review of our business, including the status of our programs, resources and

capabilities. Following this review, we determined that we would implement a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a reduction in our workforce by approximately 64% and the termination of enrollment of new patients in our ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Patients currently enrolled in the trial will be permitted to continue to participate. We made this decision, in part, because certain investors have failed to fulfill their contractual obligation to consummate the Private Placement (as defined below).

 

On August 19, 2024, we resumed enrollment of our ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA 12123 and completed enrollment of the Phase 1 study in February 2025.

 

Due to the fact that we are unable to consummate the Private Placement, management and the Board determined that it was in the best interests of the stockholders to seek a strategic alternative so that we could continue to operate. If the strategic process is unsuccessful, including if we are unable to complete our proposed merge with TuHURA, as described more fully below, the Board may decide to pursue a liquidation or obtain relief under the US Bankruptcy Code.

 

The Company cautions that trading in the Company’s securities is highly speculative and poses substantial risks. Trading prices for the Company’s securities may bear little or no relationship to the actual value realized, if any, by holders of the Company’s securities. In the event of liquidation, bankruptcy or other wind-down event, holders of our securities will likely suffer a total loss of their investment. Accordingly, the Company urges extreme caution with respect to existing and future investments in its securities.

 

 

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 mechanisms of cancer immune resistance:

Immunosuppression;
Exhausted T cells; and
Poor tumor immunogenicity

Our pipeline of assets and research interests includes (i) KVA12123, a monoclonal antibody (“mAb”) immunotherapy targeting VISTA (V-domain Ig suppressor of T cell activation) and (ii) an anti-CD27 agonist mAb immunotherapy. These immunotherapies have the potential to address disease areas with unmet medical needs and significant commercial potential.

KVA12123 is a VISTA blocking immunotherapy in development as an intravenous infusion dosed every two weeks. We dosed the first patient in a Phase 1/2 clinical trial of KVA12123 in the United States in April 2023. The ongoing Phase 1/2 clinical study is designed to evaluate KVA12123 as a monotherapy and in combination with the immune checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. Initial monotherapy safety, pharmacokinetic and biomarker data were presented at the Society for Immunotherapy of Cancer’s (SITC) annual meeting in November 2023. KVA12123 was designed to be a differentiated VISTA blocking immunotherapy to address the problem of immunosuppression in the TME. It is a fully human engineered IgG1 monoclonal antibody that binds to VISTA through a unique epitope and across neutral and acidic pHs. 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 were also developing an anti-CD27 agonist mAb immunotherapy to address the problem of exhausted T cells. The nominated lead candidate is a fully human mAb that demonstrates nanomolar (“nM”) binding affinity to CD27 in humans. In preclinical studies, our lead anti-CD27 candidate demonstrated antitumor efficacy as a single agent and in combination with other immunotherapies in multiple solid and hematological preclinical tumor models. 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 and to evaluate it in combination with other checkpoint inhibitors.

 

According to Market Data Forecast, the immuno-oncology market generated sales of approximately $111 billion in 2023 and is forecast to reach $201 billion in 2028. If we successfully complete the clinical trial program for KVA12123 and if we subsequently obtain regulatory approval for KVA12123, we will focus on initial target indications in NSCLC, CRC and OC. Initially, the clinical development of KVA12123 will be as a

 

21


 

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 KVA12123 in clinical development and the lead anti-CD27 agonist mAb 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 clinical team, an immuno-oncology focused scientific advisory board, 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.

We have never been profitable and have incurred operating losses in each period since inception. Our net losses were $1.7 million for the three months ended March 31, 2025 and $10.2 million for the three months ended March 31, 2024. As of March 31, 2025, we had an accumulated deficit of $184.6 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 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, 2025, we have raised cash from sales and issuances of common stock and borrowings under notes payable. As of March 31, 2025, we had cash of $304,000, and there is substantial doubt about our ability to continue as a going concern. For more information, see the risk factor in Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 7, 2025 (the “2024 Annual Report on Form 10-K”) entitled, “Kineta identified conditions and events that raise substantial doubt about its ability to continue as a going concern, Kineta needs substantial additional funding, and if Kineta is unable to raise capital when needed or on favorable terms, its business, financial condition, and results of operation could be materially and adversely affected.”

Proposed Merger with TuHURA Biosciences, Inc.

 

On December 11, 2024, we entered into an Agreement and Plan of Merger, which was amended by the First Amendment to the Agreement and Plan of Merger dated May 5, 2025 (as amended, the “Merger Agreement”) by and among TuHURA Biosciences, Inc., a Nevada corporation (“TuHURA”), Hura Merger Sub I, Inc., a Delaware corporation and a direct wholly-owned subsidiary of TuHURA (“Merger Sub I”), Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of TuHURA (“Merger Sub II,” and together with Merger Sub I, the “Merger Subs”), and Craig Philips, solely in his capacity as the representative, agent and attorney-in-fact of the stockholders of Kineta.

 

Pursuant to the terms of the Merger Agreement, among other things and subject to the terms and conditions set forth therein, Merger Sub I will (a) merge with and into the Company (the “First Merger”), with the Company being the surviving corporation of the First Merger, also known as the “Surviving Entity”; and (b) immediately following the First Merger and as part of the same overall transaction as the First Merger, the Surviving Entity will merge with and into Merger Sub II (the “Second Merger” and, together with the First Merger, the “Mergers” ), with Merger Sub II being the surviving company of the Second Merger, also known as the “Surviving Company.” The Mergers are intended to qualify as a tax-free reorganization for U.S. federal income tax purposes. Pursuant to the Merger Agreement, TuHURA has loaned Kineta $250,000 as of March 31, 2025.

 

For more information on the Mergers, see “Item 1. Business” and “Item 1A. Risk Factors – Risks Related to the Mergers” in the 2024 Annual Report on Form 10-K.

 

Clinical Trial Funding Agreement

Simultaneously with the execution of the Merger Agreement, Kineta and TuHURA entered into a Clinical Trial Funding Agreement (the “CTF Agreement”), pursuant to which TuHURA has loaned $852,000 to Kineta as of March 31, 2025 solely for the purpose of funding certain research and development expenses, as set forth in the CTF Agreement. The CTF Agreement grants a security interest to TuHURA in Kineta’s assets which are to be acquired by TuHURA pursuant to the Merger Agreement.

Any amounts loaned to Kineta under the CTF Agreement shall be evidenced by a secured promissory note (the “Note”), bearing interest at 5% simple interest per annum, payable on the earlier of (a) following the Closing, any date on which TuHURA demands payment by written notice to Kineta or (b) if the Merger Agreement is terminated, within ten days following the date of such termination.

No proceeds of the Note may be used for any other purposes, including without limitation, paying any operating, transaction or other expenses of the

 

22


 

Company. The Note includes customary protective provisions for the benefit of TuHURA as a lender.

Political and Geopolitical Developments

Geopolitical developments, such as the Russian invasion of Ukraine, the conflict in Israel and the Gaza Strip 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.

 

Under the current U.S. administration, there is significant and increasing uncertainty about the future relationship between the United States, China, and other exporting countries, including with respect to trade policies, treaties, government regulations, and tariffs. On April 9, 2025, President Trump announced a pause to previously announced tariffs on most countries for 90 days. Countries subject to the pause on the tariffs are still to be subject to the baseline 10% tariff. Changes in laws or policies governing the terms of trade could have a material adverse effect on our business and financial results.

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.

We have completed research and development services under the grant agreements and do not expect to earn any revenue during 2025.

Operating Expenses

Research and Development Expenses

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:

salaries, bonuses, benefits, stock-based compensation, research and consulting arrangements and other related costs for individuals involved in research and development activities;
external research and development expenses incurred under agreements with contract research organizations, investigative sites and other scientific development services;
costs incurred under agreements with contracted research and manufacturing organizations for developing and manufacturing materials for preclinical studies, clinical trials and laboratory supplies;
licensing agreements and associated costs;
costs related to compliance with regulatory requirements;
facilities and other allocated expenses for rent and insurance; and
other expenses incurred to advance research and development activities including manufacturing costs associated with production, scale up, testing and optimization of methods associated with the production of materials.

The largest component of our operating expenses has historically been our investment in research and development activities. We expect our research and development expenses to 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.

 

23


 

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 pursuing strategic alternatives such as legal and professional services.

Other (Expense) Income

Interest Income

Interest income consists of interest earned on short-term money market accounts.

Interest Expense

Interest expense consists of interest charged on outstanding invoices and outstanding borrowings associated with our debt arrangements primarily consisting of borrowings under several notes payable agreements.

Change in Fair Value Measurement of Rights from Private Placement

 

Change in fair value of other asset relates to the remeasurement of the rights from the Private Placement that we determined was a derivative, which requires the asset to be accounted for at fair value. Until settlement, this other asset is remeasured at fair value at each reporting period with the changes in fair value recorded in the statement of operations.

 

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 in the statement of operations.

Other (Expense) Income, Net

Other (expense) income, net consists of interest income and other 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 subsidiary.

Results of Operations

Comparison of the three months ended March 31, 2025 to the three months ended March 31, 2024

The following table summarizes our results of operations for the periods presented:

 

 

24


 

 

 

Three Months Ended March 31,

 

 

 

 

 

 

2025

 

 

2024

 

 

Change

 

 

 

(in thousands)

 

Revenues:

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

 

617

 

 

 

2,726

 

 

 

(2,109

)

General and administrative

 

 

1,403

 

 

 

3,680

 

 

 

(2,277

)

Total operating expenses

 

 

2,020

 

 

 

6,406

 

 

 

(4,386

)

Loss from operations

 

 

(2,020

)

 

 

(6,406

)

 

 

4,386

 

Other (expense) income:

 

 

 

 

 

 

 

 

 

Gain on sale of assets

 

 

500

 

 

 

 

 

 

500

 

Interest income

 

 

 

 

 

48

 

 

 

(48

)

Interest expense

 

 

(55

)

 

 

(42

)

 

 

(13

)

Change in fair value of rights from Private Placement

 

 

 

 

 

(3,832

)

 

 

3,832

 

Other (expense) income, net

 

 

 

 

 

(17

)

 

 

17

 

Total other (expense) income, net

 

 

445

 

 

 

(3,843

)

 

 

4,288

 

Net loss

 

 

(1,575

)

 

 

(10,249

)

 

 

8,674

 

Net income (loss) attributable to noncontrolling interest

 

 

101

 

 

 

(11

)

 

 

112

 

Net loss attributable to Kineta, Inc.

 

$

(1,676

)

 

$

(10,238

)

 

$

8,562

 

 

Revenues

 

We did not recognize any revenues for the three months ended March 31, 2025 and 2024.

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,

 

 

 

 

 

 

2025

 

 

2024

 

 

Change

 

 

 

(in thousands)

 

Direct external program expenses:

 

 

 

 

 

 

 

 

 

KVA12123 program

 

$

641

 

 

$

1,838

 

 

$

(1,197

)

CD27 program

 

 

(191

)

 

 

430

 

 

 

(621

)

KCP-506 program

 

 

(42

)

 

 

23

 

 

 

(65

)

Internal and unallocated expenses:

 

 

 

 

 

 

 

 

 

Personnel-related costs

 

 

188

 

 

 

348

 

 

 

(160

)

Facilities and related costs

 

 

 

 

 

40

 

 

 

(40

)

Other costs

 

 

21

 

 

 

47

 

 

 

(26

)

Total research and development expenses

 

$

617

 

 

$

2,726

 

 

$

(2,109

)

 

Research and development expenses were $617,000 for the three months ended March 31, 2025 and $2.7 million for the three months ended March 31, 2024 and decreased by $2.1 million, or 77%. The decrease in direct external program expenses of $1.9 million was primarily due to lower activities for KVA12123, our lead product candidate, and suspension of other programs in 2024 due to failure to receive funding in April 2024 as expected. The decrease in KVA12123 was primarily due to lower clinical and manufacturing costs. The decrease in the CD27 and KCP-506 programs was due to suspension of those programs in 2024 and reversal of accrued costs no longer needed. The decrease in our internal and unallocated research and development expenses of $226,000 was primarily due to lower personnel-related costs due to lower headcount and lower facilities allocations expense as we transitioned to clinical trials and ceased using our laboratory space.

General and Administrative Expenses

General and administrative expenses were $1.4 million for the three months ended March 31, 2025 and $3.7 million for the three months ended March 31, 2024 and decreased by $2.3 million, or 62%. This decrease was primarily due to decreases in professional fees of $1.2 million, personnel costs of $672,000 and facilities costs of $286,000. Professional fees decreased due to lower non recurring consulting services. Personnel costs decreased primarily due to lower salaries and benefits of $231,000 and lower stock-based compensation of $226,000 due to lower headcount in 2025 as compared to 2024 and lower severance costs of $133,000 due to a staff reduction in March 2024.

 

Other Income and expense, net

 

Interest Income

 

25


 

Interest income was zero for the three months ended March 31, 2025 and $48,000 for the three months ended March 31, 2024 and decreased by $48,000. Interest income decreased due to lower balances in interest-bearing accounts during 2025.

 

Interest Expense

Interest expense was $55,000 for the three months ended March 31, 2025 and $42,000 for the three months ended March 31, 2024. Interest expense increased primarily due to interest on outstanding vendor invoices.

Change in Fair Value Measurement of Private Placement

Change in fair value of Private Placement was zero for the three months ended March 31, 2025 and a loss of $3.8 million for the three months ended March 31, 2024. The second closing of the Private Placement did not occur during 2024 and as a result, we deemed the fair value of the rights from Private Placement to be zero as of March 31, 2024. These changes relate to the remeasurement of the rights from the Private Placement that we determined was a derivative, which requires the asset to be accounted for at fair value. We determined the rights from Private Placement to be a derivative asset when we added a minimum purchase price of $3.18 upon an amendment in 2023.

 

Other (Expense) Income, Net

Other (expense) income, net was a gain of $500,000 for the three months ended March 31, 2025 consisting of a gain on sale of KCP assets. Other (expense) income, net was a loss of $17,000 for the three months ended March 31, 2024 primarily consisting of a loss of $9,000 of fair value of notes payable.

Going Concern and Capital Resources

 

Exploring Strategic Alternatives

 

We require substantial additional capital to sustain our operations and pursue our growth strategy, including the development of our product candidates. We are exploring strategic alternatives that may include, but are not limited to, sale of assets of the Company, a sale of the Company, licensing of assets, a merger, liquidation or other strategic action. If a strategic process is unsuccessful, the Board may decide to pursue a liquidation or obtain relief under the US Bankruptcy Code. These factors raise substantial doubt about our ability to continue as a going concern.

 

Sources of Liquidity

Since our inception through March 31, 2025, 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 and milestone payments from our license agreements and payments from TuHURA in connection with agreements with them. As of March 31, 2025, we had $304,000 in cash and an accumulated deficit of $184.6 million. We expect that our research and development and general and administrative 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.

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:

the progress, timing, scope, results and costs of the clinical trials of VISTA and preclinical studies or clinical trials of other potential product candidates we may choose to pursue in the future, including the ability to enroll patients in a timely manner for our clinical trials;
the costs and timing of obtaining clinical and commercial supplies and validating the commercial manufacturing process for VISTA and any other product candidates we may identify and develop;
the cost, timing and outcomes of regulatory approvals;
the timing and amount of any milestone, royalty or other payments we are required to make pursuant to current or any future collaboration or license agreements;

 

26


 

costs of acquiring or in-licensing other product candidates and technologies;
the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements;
the costs associated with attracting, hiring and retaining existing and additional qualified personnel as our business grows;
efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting; and
the cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

As of March 31, 2025, we had cash of $304,000, and there is substantial doubt about our ability to continue as a going concern. Based on our current operating plans, we do not have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

We are exploring strategic alternatives that may include, but are not limited to, sale of assets of the Company, a sale of the Company, licensing of assets, a merger, liquidation or other strategic action.

 

We may seek additional funds through equity or debt financings or through collaborations, licensing transactions or other sources that may be identified through our strategic process. However, there can be no assurance that we will be able to complete any such transactions on acceptable terms or otherwise. The failure to obtain sufficient funds on commercially acceptable terms when needed would have a material adverse effect on our business, results of operations, and financial condition. These factors raise substantial doubt about our ability to continue as a going concern.

 

We do not currently have any commitments for future funding or additional capital. As noted above, the investors failed to fulfill their contractual obligation to consummate the Private Placement. We are pursuing litigation or seeking other settlements against the investors for the failure to fund. Due to the lack of commitments for future funding or additional capital, we have paused or significantly scaled back the development or commercialization of our future product candidates or other research and development initiatives. If we are unable to complete a strategic transaction or raise additional capital in sufficient amounts, we will not be able to continue our business and we may need to file for bankruptcy protection.

Cash Flows

The following table summarizes our cash flows for the periods indicated:

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

 

 

(in thousands)

 

Net cash provided by (used in):

 

 

 

Operating activities

 

$

(1,440

)

 

$

(4,011

)

Investing activities

 

 

 

 

 

 

Financing activities

 

 

1,110

 

 

 

1

 

Net change in cash and cash equivalents

 

$

(330

)

 

$

(4,010

)

 

Operating Activities

Cash used in operating activities for the three months ended March 31, 2025 was $1.4 million, consisting of a net loss of $1.6 million and a change in other net operating assets and liabilities of $106,000, partially offset by noncash charges of $241,000. Our change in net operating assets and liabilities primarily resulted from an increase in prepaid expenses and other current assets of $153,000 and increase in accounts payable and accrued liabilities of $37,000.The noncash charges primarily consisted of $241,000 in stock-based compensation and a loss on exchange of warrants.

Cash used in operating activities for the three months ended March 31, 2024 was $4.0 million, consisting of a net loss of $10.2 million, partially offset by noncash charges of $5.0 million and a change in other net operating assets and liabilities of $1.3 million. The noncash charges primarily consisted of a $3.8 million change in fair value of rights from Private Placement, $477,000 in stock-based compensation, $469,000 in common stock issued for services and $199,000 noncash operating lease expense. Our change in net operating assets and liabilities primarily resulted from an increase in accounts payable and accrued liabilities of $1.7 million and prepaid expenses and other current assets of $193,000, partially offset by a decrease in operating lease liability of $228,000.

Financing Activities

Cash provided by financing activities was $1.1 million for the three months ended March 31, 2025 primarily related to proceeds of $1.1 million from loan advances from TuHURA.

Cash provided by financing activities for the three months ended March 31, 2024 was insignificant.

 

Debt Obligations

Notes Payable

 

27


 

As of March 31, 2025, we had outstanding notes payable in an aggregate principal amount of $629,000 at an interest rate of 6%. Notes payable of $379,000 matured on June 30, 2024 and a note payable of $250,000 matured on July 31, 2024. As of March 31, 2025, the notes remain unpaid and are payable upon demand by a majority of the holders.

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.

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, 2025, 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 leased office and laboratory space for our corporate headquarters in Seattle, Washington under a lease agreement that expired on July 31, 2024. This lease was not renewed and no other facility lease was entered into as the Company employees are working remotely.

 

On September 13, 2024 (the “Agreement Effective Date”), we entered into a Settlement Agreement, which was amended on February 4, 2025 (as amended, the “Agreement”) with ARE-SEATTLE No. 17, LLC (the “Landlord”), the landlord of our former premises in Seattle, Washington. Under the terms of the Agreement, we have agreed to pay the Landlord the outstanding monetary obligation of $679,000 (the “Outstanding Debt”) pursuant to that certain Lease Agreement, by and between us and the Landlord, dated as of November 19, 2010, as amended through June 30, 2020 (collectively, the “Lease”) as follows: (i) the Landlord’s application of the security deposit in the amount of $70,000, (ii) our payment to the Landlord of $85,000 (the “First Payment”) no later than five (5) business days after the Agreement Effective Date, and (iii) our payment to the Landlord of the Outstanding Debt balance of $524,000 (the “Second Payment” and together with the First Payment, the “Payment Milestones”) no later than May 31, 2025. The Agreement stipulates that upon the receipt by the Landlord of the Payment Milestones, the Landlord will fully discharge and forever release us from any claim, cause of action, or judgment, legal or equitable, in contract or tort, direct or indirect, presently asserted or not, known or unknown, through the date of the Agreement related to our monetary obligations under the Lease. We paid the First Payment to the Landlord on September 18, 2024.

 

Additionally, under the Agreement, as consideration for the Landlord’s agreement to delay collection of the Outstanding Debt and to not assess additional interest and late fees with respect to the Outstanding Debt, we executed a Confession of Judgment (the “Confession”) in favor of the Landlord, and as consideration for our agreement to execute the Confession, the Landlord agreed not to file any lawsuit or other legal action against us related to the Outstanding Debt, or to otherwise cause the Confession to be entered into any legal action or proceeding unless we fail to satisfy the Payment Milestones. The Agreement specifies that except as it relates to the matters contemplated in the Agreement, no action by the parties is to be construed as an admission of liability by any party as it relates to such parties’ rights or obligations under the Lease.

 

We entered into the Agreement to avoid the costs and uncertainties of legal proceedings, reflecting the Company’s commitment to responsibly managing its financial obligations and disputes as we continue to explore strategic alternatives.

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 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, 2025 were consistent with those in Part II, Item 7 of our 2024 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.

 

 

28


 

Evaluation of Disclosure Controls and Procedures

In connection with the audits of our financial statements for the years ended December 31, 2024 and 2023, 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 identified for the year ended December 31, 2024 relates to the accounting for the exclusivity payments related to a business combination. There were also material weaknesses identified in prior periods accounting for (i) complex financial instruments related to the derivative asset, (ii) allocated facilities costs, (iii) complex financial instruments related to warrants issued to certain existing stockholders, (iv) offering costs and (v) accounting for the exclusivity payments related to a business combination, which all remain unremediated.

 

Our management, with the participation of our President 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, 2025. Based on this evaluation and for the reasons set forth above, our President and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of March 31, 2025.

 

We have designed and implemented improved processes and internal controls, including ongoing senior management review and audit committee oversight. Additionally, we have implemented and upgraded accounting and reporting systems to improve accounting and financial reporting processes and has enhanced, developed and implemented formal policies, processes and documentation procedures relating to financial reporting, including the oversight of third-party service providers. The actions that our management has taken 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 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over current or future financial reporting.

 

29


 

PART II - OTHER INFORMATION

On March 20, 2024, Kineta filed a complaint in the Court of Chancery of the State of Delaware against Growth & Value Development Inc. (“GVDI”), alleging breach of contract in connection with GVDI’s recent repudiation of its obligation to provide a substantial tranche of funding for Kineta as required under the Securities Purchase Agreement. The complaint provides that Kineta will seek specific performance of GVDI’s obligations under the Securities Purchase Agreement and damages equal to the amount of the unpaid funding and any damages resulting from GVDI’s breach.

 

On May 30, 2024, Kineta filed a complaint in the Court of Chancery of the State of Delaware against Myron Wolff, alleging breach of contract in connection with Myron Wolff’s recent repudiation of its obligation to provide a substantial tranche of funding for Kineta as required under the Securities Purchase Agreement. The complaint provides that Kineta will seek specific performance of Myron Wolff’s obligations under the Securities Purchase Agreement and damages equal to the amount of the unpaid funding and any damages resulting from Myron Wolff’s breach.

 

On March 28, 2025, Kineta entered into a settlement agreement and mutual general release with Wolff Family Office LLC to settle the complaint against Myron Wolff and received $2,500 the Wolff Family Office LLC.

 

Except as disclosed in the preceding paragraphs, Kineta is currently not a party to any other material legal proceedings. From time to time, however, 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.

Item 1A. Risk Factors.

 

There have been no material changes to our risk factors included in our 2024 Annual Report on Form 10-K.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

On March 7, 2025, the Company entered into a securities exchange agreement (the “Exchange Agreement”) with an existing investor (the “Holder”) pursuant to which the Company agreed to issue an aggregate of 1,880,342 shares of common stock, par value $0.001 per share (the “Common Stock”) consisting of (i) an aggregate of 1,225,323 shares (the “Shares”) of Common Stock, which is equal to a maximum beneficial ownership of 9.99% of the Company’s total number of Common Stock outstanding as of the date of the Exchange Agreement, and (ii) a pre-funded warrant to purchase up to an aggregate of 655,019 shares of Common Stock (the “Pre-Funded Warrant”), in exchange for certain outstanding warrants (the “Prior Warrant”) held by the Holder to purchase up to 2,315,387 shares of Common Stock with exercise prices ranging from $3.25 to $4.08 (the “Exchange”). The Company has cancelled the Prior Warrant reacquired in the exchange and such Prior Warrant will not be reissued.

 

In addition, pursuant to the Exchange Agreement, in connection with the transactions contemplated by the Merger Agreement, by and among Kineta, TuHURA, Hura Merger Sub I, Hura Merger Sub II, and Craig Philips, as representative of the stockholders of Kineta, the Holder agreed to (i) appear in person or online (for a virtual meeting) or by proxy at the applicable meeting of the stockholders of the Company (the “Stockholders Meeting”) called to seek the approval of the stockholders of the transactions contemplated by the Merger Agreement (the “Proposals”) or otherwise cause the shares held by the Holder as of the record date for the applicable Stockholders Meeting (the “Owned Shares”) to be counted as present at such meeting for purposes of establishing a quorum and (ii) vote (or cause to be voted) the Owned Shares in favor of the approval of the Proposals.

 

The issuance of the Shares pursuant to the Exchange Agreement was made in reliance on an exemption from registration under Section 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”). The issuance of the Shares has not been registered under the Securities Act and as such, the Shares may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.

 

30


 

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

 

 

 

Item 5. Other Information.

 

On May 12, 2025, Kineta entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Philanthropos Therapeutics, LLC (“Philanthropos”) pursuant to which Philanthropos agreed to acquire certain assets and properties of Kineta related to the development of LHF-535, a product candidate for the treatment of Lassa Fever. Under the terms of the Purchase Agreement, Philanthropos will acquire all right, title, and interest in the specified assets, including intellectual property, contracts, permits, inventory, tangible personal property, business records, warranties, and certain prepaid expenses, for an aggregate upfront purchase price of $50,000, of which $10,000 was received in March 2025 and the remaining $40,000 was received in May 2025. In addition to the upfront payment, Kineta is entitled to receive revenue sharing payments during a six-year period following the later of the closing of the transactions contemplated by the Merger Agreement and the Effective Date, including (i) a 5% royalty on Net Product Sales derived from the Intellectual Property Rights, (ii) 5% of the net sales price of any Priority Review Voucher associated with the Intellectual Property Rights that is received and sold by Philanthropos, and (iii) 15% of gross Consideration received by Philanthropos from any sale or license of the Product or Seller Product, in whole or in part, associated with the Intellectual Property Rights.

 

Insider Trading Arrangements

 

During the three months ended March 31, 2025, none of our directors or officers informed us of the adoption, modification or termination of a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408.

 

31


 

Item 6. Exhibits.

 

Exhibit

Number

Description

2.1++

 

Agreement and Plan of Merger, dated June 5, 2022, by and among the Company, Kineta Operating, Inc. and Yacht Merger Sub, Inc. (filed as Exhibit 2.2 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on June 6, 2022 and incorporated herein by reference).

2.2

 

Form of Amendment No. 1 to the Agreement and Plan of Merger, dated as of December 5, 2022, by and among the Company, Kineta Operating, Inc. and Yacht Merger Sub, Inc. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on December 5, 2022 and incorporated herein by reference).

2.3++

 

Agreement and Plan of Merger, dated December 11, 2024, by and among TuHURA, Kineta, the Merger Subs and the Stockholders Representative (filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on December 12, 2024 and incorporated herein by reference).

2.4

 

First Amendment to the Agreement and Plan of Merger, dated May 5, 2025, by and among TuHURA, Kineta, the Merger Subs and the Stockholders Representative (incorporated by reference to Exhibit 2.2 of the Amendment No. 1 to Form S-4 Registration Statement filed on May 6, 2025).

3.1

 

Fifth Amended and Restated Certificate of Incorporation of the Company (filed as Exhibit 3.1 to the Company’s Registration Statement on Form S-3 (File No. 333-228529) as filed with the SEC on November 23, 2018 and incorporated herein by reference).

3.2

 

Certificate of Amendment of Fifth Amended and Restated Certificate of Incorporation of the Company, dated December 22, 2020 (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on December 30, 2020 and incorporated herein by reference).

3.3

 

Certificate of Amendment of Fifth Amended and Restated Certificate of Incorporation of the Company, dated December 22, 2020 (filed as Exhibit 3.2 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on December 30, 2020 and incorporated herein by reference).

3.4

 

Certificate of Amendment of Fifth Amended and Restated Certificate of Incorporation of the Company, dated December 16, 2022 (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on December 22, 2022 and incorporated herein by reference).

3.5

 

Certificate of Amendment of Fifth Amended and Restated Certificate of Incorporation of the Company, dated December 16, 2022 (filed as Exhibit 3.2 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on December 22, 2022 and incorporated herein by reference).

3.6

 

Fourth Amended and Restated By-laws of the Company, dated December 16, 2022 (filed as Exhibit 3.3 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on December 22, 2022 and incorporated herein by reference).

4.1

 

Pre-Funded Warrant dated March 7, 2025 (filed as Exhibit 4.1 to the Company's Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on March 7, 2025 and incorporated herein by reference).

10.1

 

Securities Exchange Agreement dated March 7, 2025 (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-37695) as filed with the SEC on March 7, 2025 and incorporated herein by reference).

31.1*

Certification of Principal Executive Officer 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.

31.2*

Certification of Principal Financial Officer 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.

32.1**

Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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

104

 

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

* Filed herewith.

** Furnished herewith.

 

++ Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) 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 15, 2025

By:

/s/ Craig Philips

Craig Philips

President

 

 

 

 (Principal Executive Officer)

 

 

 

 

Date: May 15, 2025

 

By:

/s/ Keith A. Baker

 

 

 

Keith A. Baker

 

 

 

Chief Financial Officer

 

 

 

  (Principal Financial Officer)

 

 

 

 

 

33