03/31/2026 | Press release | Distributed by Public on 03/31/2026 15:16
Management's Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth under the heading "Risk Factors" in Part I, Item 1A of this Annual Report on Form 10-K 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. See also "Forward-Looking Statements".
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the year ended December 31, 2025 compared to the year ended December 31, 2024. A discussion of our financial condition, changes in financial condition and results of our operations for the year ended December 31, 2024 compared to the year ended December 31, 2023 can be found under Part II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," in our Annual Report on Form 10-K for the year ended December 31, 2024 which was filed with the SEC on March 31, 2025 and is available on the SEC's website at www.sec.govas well as our website at ir.tuhurabio.com. References to "we", "our" and "the Company" refers to Legacy TuHURA for periods prior to the closing of the Kintara Merger, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc.) for all other periods, as the context requires.
Overview
We are a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer immunotherapies. Our proprietary Immune FxTMtechnology platform, or IFx, is an innate immune agonist technology designed to "trick" the body's immune system to attack tumor cells by making tumor cells look like bacteria. Our lead product candidate, IFx2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. In June 2025, we initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naïve utilizing the FDA's accelerated approval pathway. In addition to our IFx technology platform, in June 2025 we acquired the rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody formerly known as KVA1213, through our acquisition of Kineta on June 30, 2025. VISTA (otherwise referred to as V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells that is believed to be a strong driver of immunosuppression in the tumor microenvironment and is believed to be a primary mechanism by which leukemic blasts escape immune recognition contributing to low relapse rates and high rates of recurrence in acute myeloid leukemia, or AML. Following our acquisition of Kineta, we are currently planning on investigating TBS-2025 in a randomized Phase 2 trial in combination with a menin inhibitor vs menin inhibitor alone in mutated NPM1 (mutNPM1) AML.
To date, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, identifying and developing product candidates, enhancing our intellectual property portfolio, undertaking research, conducting preclinical studies and clinical trials, and securing manufacturing for our development programs. We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through the issuance of capital stock, warrants and convertible notes.
We are not profitable and has incurred significant operating losses in each period since our inception, including net losses of $30.1 million for the year ended December 31, 2025, and $21.7 million for the year ended December 31, 2024. As of December 31, 2025, we had an accumulated deficit of $141.2 million. Our operating losses may fluctuate significantly from quarter-to-quarter and year-to-year as a result of several factors, including the timing of our preclinical studies and clinical trials and the expenditures related to other research and development activities. We expect to continue to incur operating losses. We anticipate these losses will increase substantially as it advances our product candidates through preclinical and clinical development, develops additional product candidates and seeks regulatory approvals for our product candidates. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtains regulatory approval for one or more product candidates. In addition, if we obtain marketing approval for any product candidate, we expect to incur pre-commercialization expenses and significant commercialization expenses related to marketing, sales, manufacturing and distribution. We may also incur expenses in connection with the in-licensing of additional product candidates.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity offerings, debt financings, collaborations and licensing arrangements or other capital sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial
condition and could force it to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates that we would otherwise prefer to develop and market itself.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
As of December 31, 2025, we had cash and cash equivalents of $3.6 million. See " - Liquidity and Capital Resources" below.
Recent Developments
ATM Offering
On November 3, 2025, the Company and H.C. Wainwright & Co., LLC ("Wainwright") entered into an At-The-Market Offering Agreement (the "Offering Agreement") with respect to an at-the-market offering program under which the Company may sell shares of its common stock having an aggregate offering price of up to $50,000,000 through Wainwright as its sales agent. As of the date of this Annual Report, we have not sold any shares of common stock through the program.
December 2025 Registered Direct Offering
On December 9, 2025, TuHURA Biosciences, Inc. (the "Company") entered into a securities purchase agreement (the "Purchase Agreement") with certain investors (collectively, the "Purchasers"). The Purchase Agreement relates to the sale and issuance in a registered direct offering (such sale and issuance, the "Offering"), by the Company of an aggregate of: (i) 9,462,423 shares of the Company's common stock, (ii) Series A common stock purchase warrants to purchase up to 9,462,423 shares of common stock (the "Series A Warrants"), and (iii) Series B common stock purchase warrants to purchase up to 9,462,423 shares of common stock (the "Series B Warrants", and together with the Series A Warrants, the "Common Warrants").The offering price for each share of common stock and accompanying Series A Warrant and Series B Warrant was $1.65. Each Common Warrant has an exercise price of $1.95 per share and is exercisable beginning six months after the date of issuance.
On the same date, the Company and K&V Investment One LLC ("K&V"), a Purchaser in the Offering, entered into a side letter to the Purchase Agreement (the "Side Letter"), whereby the Company and K&V agreed that, for purposes of K&V's funding requirements under the Purchase Agreement, K&V shall fund (i) with respect to $5 million of K&V's subscription amount, at a date chosen by K&V that is no later than January 30, 2026 (the "Second Closing"), and (ii) with respect to $2 million of K&V's subscription amount, at a date chosen by K&V that is no later than February 27, 2026 (the "Third Closing"). The Company will issue to K&V the shares of common stock and Warrants purchased at each of the Second Closing and Third Closing following receipt of consideration thereof, with such issued Warrants exercisable six months following the date of the Second Closing and the date of the Third Closing, respectively, and expiring on the same date as the Warrants issued to the other Purchasers on December 10, 2025, the first closing date (the "First Closing").
Pursuant to the terms of the Purchase Agreement and the Side Letter, the closing of the Offering occurred in three tranches. At the First Closing, the Company issued an aggregate of 5,219,999 Shares, Series A Warrants to purchase up to an aggregate of 5,219,999 shares of common stock and Series B Warrants to purchase up to an aggregate of 5,219,999 shares of common stock. At the Second Closing, the Company issued to K&V an aggregate of 3,030,303 Shares, Series A Warrants to purchase up to an aggregate of 3,030,303 shares of common stock and Series B Warrants to purchase up to an aggregate of 3,030,303 shares of common stock. At the Third Closing, the Company issued to K&V an aggregate of 1,212,121 Shares, Series A Warrants to purchase up to an aggregate of 1,212,121 shares of common stock and Series B Warrants to purchase up to an aggregate of 1,212,121 shares of common stock. The Series A Warrants will expire five and one-half years from the date of the First Closing and the Series B warrants will expire twenty-four months from the date of the First Closing.
The Offering resulted in gross proceeds to the Company of approximately $8.6 million from the First Closing, approximately $5.0 million from the Second Closing and approximately $2.0 million from the Third Closing, before deducting the placement agents' fees and other offering expenses payable by the Company.
June 2025 Private Placement
On June 2, 2025, the Company and certain accredited investors (the "Private Placement Purchasers") entered into a securities purchase agreement (the "Securities Purchase Agreement") pursuant to which the Company agreed to issue to the Private Placement Purchasers, in a private placement (the "Private Placement"), an aggregate of 4,759,309 shares of common stock together with warrants to purchase an equal number of shares of common stock at an exercise price of $3.3125 (the "Private Placement Warrants"), for an aggregate gross offering amount of approximately $12.6 million. The combined effective offering price for each share and accompanying Private Placement Warrant in the Private Placement was $2.65. The Private Placement Warrants have an exercise price per share equal to $3.3125 and will expire on December 31, 2030. The exercise price of the Private Placement Warrants is subject to proportional adjustment for stock splits, reverse stock splits, and similar transactions.
Pursuant to the Securities Purchase Agreement, each Private Placement Purchaser was obligated to purchase such Private Placement Purchaser's respective investment in the Private Placement in four equal tranches, as follows:
In addition to the approximately $8.9 million that was purchased in four equal tranches pursuant to the foregoing milestones, the remaining $3.7 million in the Private Placement (the "Final Tranche Offering Amount") was required to be purchased and funded by December 31, 2025 by certain Private Placement Purchasers who agreed to invest an aggregate of $4.0 million or more in the Private Placement and who elected to defer the purchase of a portion of such Private Placement Purchaser's common stock and Private Placement Warrants until such time (the "Deferral Investors").
On September 5, 2025, each of Deferral Investors and the Company entered into an agreement (the "Final Purchase Agreements") pursuant to which they agreed to immediately purchase an aggregate of $3.2 million of the Final Tranche Offering Amount in exchange for the Company's agreement, set forth in a Warrant Amendment Agreement between the Company and each Deferral Investor (the "Warrant Amendment Agreements"), to extend the expiration dates of certain warrants to purchase an aggregate of 1.5 million shares of Company common stock that were issued by the Company's predecessor in a 2024 private placement of convertible notes (the "2024 Warrants"). An aggregate of $0.5 million remained outstanding in the Final Tranche Offering Amount and was purchased on December 31, 2025. Under the Warrant Amendment Agreements, the expiration dates of the 2024 Warrants was extended to December 31, 2030. The modification of the 2024 Warrants was related to the Private Placement and the incremental fair value relating to the modification has no net equity effect.
Merger with Kineta, Inc.
On June 30, 2025, the Company completed the previously announced acquisition contemplated by the Agreement and Plan of Merger, dated December 11, 2024, and as amended by that certain First Amendment to Agreement and Plan of Merger, dated May 5, 2025 (as amended, the "TuHURA-Kineta Merger Agreement"), by and among the Company, Hura Merger Sub I, Inc., a Delaware corporation and a direct wholly-owned subsidiary of the Company ("Merger Sub I"), Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of the Company ("Merger Sub II"), Kineta, and Craig Philips, solely in his capacity the representative, agent and attorney-in-fact of the stockholders of Kineta. Pursuant to the terms of the TuHURA-Kineta Merger Agreement, among other things, Merger Sub I (a) merged with and into Kineta (the "First Merger"), with Kineta being the surviving corporation of the First Merger, also known as the "Surviving Entity" and (b) immediately following the First Merger, the Surviving Entity merged with and into Merger Sub II (the "Second Merger", and together with the First Merger, the "Kineta Merger"), with Merger Sub II being the surviving company of the Second Merger and subsequently changing its name to Kineta, LLC.
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each share of Kineta common stock, par value $0.001 per share (each, a "Kineta Share"), issued and outstanding immediately prior to the First Merger, was converted into the right to receive 0.185298 shares of the Company's common stock for an aggregate of
approximately 2,868,169 shares of Company common stock. Also pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Kineta Share received its pro rata portion of approximately 1,129,880 shares of Company common stock in December 2025, in accordance with the terms of the TuHURA-Kineta Merger Agreement. In addition, each Kineta Share is entitled to the right to its pro rata share of cash consideration received by Kineta pursuant to disposed asset payments related to legacy Kineta assets. Such payments, if any, will be made at a later date and in accordance with the terms of the TuHURA-Kineta Merger Agreement. In each case, in lieu of the issuance of any fractional shares of Company common stock, we will pay an amount equal to the product of (A) such fractional share and (B) $5.7528. As of the date of this Annual Report, all 1,129,880 shares of common stock were issued to the Kineta shareholders and no cash consideration has been received.
Merger with Kintara Therapeutics
On October 18, 2024, we completed the transactions contemplated by the Kintara Merger Agreement. Pursuant to the Kintara Merger Agreement, Merger Sub merged with and into Legacy TuHURA with Legacy TuHURA surviving the merger and becoming Kintara's direct, wholly-owned subsidiary. In connection with the completion of the Kintara Merger, effective at 12:01 a.m. Eastern Time on October 18, 2024, Kintara effected a 1-for-35 reverse stock split of its common stock (the "Reverse Stock Split"). Effective at 12:03 a.m. Eastern Time on October 18, 2024, the Kintara Merger was completed, and effective at 12:04 a.m. Eastern Time on October 18, 2024, Kintara changed its name to "TuHURA Biosciences, Inc."
The Kintara Merger is being accounted for as a reverse recapitalization in accordance with U.S. GAAP, with Kintara treated as the acquired company for financial reporting purposes and TuHURA treated as the accounting acquirer. The Kintara Merger is intended to qualify for U.S. federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Code.
Subject to the terms and conditions of the Kintara Merger Agreement, at the closing of the Kintara Merger, (a) each then-outstanding share of Legacy TuHURA common stock (other than shares held in treasury and excluding dissenting shares), including shares of Legacy TuHURA common stock issued upon conversion of Legacy TuHURA preferred stock and conversion of all of our convertible promissory notes issued in the Legacy TuHURA's note financing, were converted into the right to receive a number of shares of Kintara common stock (after giving effect to the Reverse Stock Split) based on an exchange ratio of 0.1789 shares of Kintara common stock for each outstanding share of Legacy TuHURA common stock per the Kintara Merger Agreement (the "Exchange Ratio"), and (b) each then-outstanding Legacy TuHURA stock option and warrant that was not exercised immediately prior to the effective time of the Kintara Merger was assumed by Kintara with the number of underlying shares and exercise price being adjusted in accordance with the Exchange Ratio.
Also at the closing of the Kintara Merger, Kintara entered into a Contingent Value Rights Agreement with the Rights Agent (as defined in the Kintara Merger Agreement), pursuant to which holders of Kintara common stock and Kintara common stock warrants, in each case, as of the close of business on the business day immediately prior to the effective time of the Kintara Merger, received one contingent value right (a "CVR") for each outstanding share of Kintara held by such stockholder (or, in the case of the warrants, each share of Kintara common stock for which such warrant is exercisable). Following the achievement of certain prescribed milestones, each CVR received in December 2025 its pro rata portion of 1,539,918 shares of TuHURA common stock.
Components of Our Results of Operations
Revenue
We did not generate any revenue and do not expect to generate any revenue from the sale of products in the near future.
Research and Development Expenses
To date, our research and development expenses have related primarily to the development of IFx-2.0, IFx-3.0 (which we are no longer advancing), TBS-2025, manufacturing, clinical studies, and other early pre-clinical activities related to our portfolio. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
Research and development expenses include:
Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as CROs, independent clinical investigators and other third-party service providers to assist us with the execution of our clinical trials.
We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and seek to discover and develop new product candidates.
Due to the inherently unpredictable nature of preclinical and clinical development, we cannot determine with certainty the timing of the initiation, duration or costs of future clinical trials and preclinical studies of product candidates. Clinical and preclinical development timelines, the probability of success and the amount of development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates and development programs to pursue and how much funding to direct to each product candidate or program on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate's commercial potential. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Our future clinical development costs may vary significantly based on factors such as:
Acquisition-related costs
Acquisition-related costs consist of expenses incurred to effect a business combination, including legal, advisory, accounting, and valuation fees and were expensed as incurred.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in our executive, finance, and other administrative functions. Other significant costs include facility related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services and insurance costs. We anticipate that our general and administrative expenses will increase in the future to support our continued research and development activities, and, if any product candidates receive marketing approval, commercialization activities.
Other (Expense) Income
Other expense income (expense) consists of grant income from a NIH-funded research grant from Legacy Kintara REM-001, employee retention tax credit for companies affected by the COVID-19 pandemic, loss on settlements related to Kineta former employees separation payments, interest income on our cash and cash equivalents, interest expense on borrowings under our convertible note agreements and 2025 bridge loan, and non-cash changes in the fair value of our derivative liability associated with the make-whole premium on our convertible notes and holdback shares on the Kineta Merger.
Preferred Series A Cash Dividend
Preferred Series A cash dividend represents a cash dividend payable to Valent Technologies, LLC, the holder of our Series A Preferred Stock. Effective September 30, 2014, Kintara filed a Certificate of Designation of Series A Preferred Stock with the Secretary of State of Nevada, pursuant to which, Kintara designated and thereafter issued 278,530 shares of preferred stock as Series A Preferred Stock. The shares of Series A Preferred Stock have a state value of $1.00 per share (the "Series A Stated Value") and are not convertible into shares of our common stock. The holder of the Series A Preferred Stock is entitled to dividends at the rate of 3% of the Series A Stated Value, payable quarterly in arrears. The dividend has been recorded as a direct increase in accumulated deficit.
Warrant Modification
Warrant modification represents an extension of the exercise period of common stock purchase warrants issued in connection with Legacy TuHURA Series A Preferred Stock for an additional six months, with a new expiry date of February 12, 2025. The warrant modification has been recorded as a direct increase in accumulated deficit.
Results of Operations
Comparisons for the Years Ended December 31, 2025, and December 31, 2024
|
Year ended |
||||||||||||
|
December 31, |
Change |
|||||||||||
|
2025 |
2024 |
|||||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
$ |
20,532,670 |
$ |
13,335,316 |
$ |
7,197,354 |
||||||
|
Acquisition-related costs |
3,679,618 |
440,340 |
3,239,278 |
|||||||||
|
General and administrative |
7,583,651 |
3,873,836 |
3,709,815 |
|||||||||
|
Total operating expenses |
31,795,939 |
17,649,492 |
14,146,447 |
|||||||||
|
Loss from operations |
(31,795,939 |
) |
(17,649,492 |
) |
(14,146,447 |
) |
||||||
|
Other (expense) income |
||||||||||||
|
Employee retention tax credit |
113,574 |
- |
113,574 |
|||||||||
|
Grant income |
713,508 |
57,627 |
655,881 |
|||||||||
|
Interest expense |
(625,283 |
) |
(4,138,301 |
) |
3,513,018 |
|||||||
|
Interest income |
136,233 |
361,632 |
(225,399 |
) |
||||||||
|
Change in fair value of derivative liability |
- |
(313,772 |
) |
313,772 |
||||||||
|
Change in fair value of Kineta merger holdback shares |
1,590,949 |
- |
1,590,949 |
|||||||||
|
Loss on Kineta employee separation payments assumed from merger |
(185,019 |
) |
- |
(185,019 |
) |
|||||||
|
Total other income (expense) |
1,743,962 |
(4,032,814 |
) |
5,776,776 |
||||||||
|
Net loss |
$ |
(30,051,977 |
) |
$ |
(21,682,306 |
) |
$ |
(8,369,671 |
) |
|||
|
Series A Preferred cash dividend |
(8,356 |
) |
(2,089 |
) |
(6,267 |
) |
||||||
|
Warrant modification |
- |
(965,177 |
) |
965,177 |
||||||||
|
Net loss attributable to common shareholders |
$ |
(30,060,333 |
) |
$ |
(22,649,572 |
) |
$ |
(7,410,761 |
) |
|||
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
|
Year ended |
||||||||||||
|
December 31, |
Change |
|||||||||||
|
2025 |
2024 |
|||||||||||
|
Direct program costs: |
||||||||||||
|
IFx-2.0 |
$ |
8,291,119 |
$ |
7,286,318 |
$ |
1,004,801 |
||||||
|
TBS-2025 |
622,796 |
- |
622,796 |
|||||||||
|
Preclinical research costs |
1,650,881 |
702,628 |
948,253 |
|||||||||
|
Indirect program costs: |
||||||||||||
|
Personnel and facilities related costs |
9,967,874 |
5,346,370 |
4,621,504 |
|||||||||
|
Total research and development expenses |
$ |
20,532,670 |
$ |
13,335,316 |
$ |
7,197,354 |
||||||
Research and development expenses were $20.5 million and $13.3 million for the years ended December 31, 2025, and 2024, respectively. The increase of $7.2 million related to the following.
Acquisition-related costs. Acquisition related costs were $3.7.million and $0.4 million for the years ended December 31, 2025, and 2024, respectively, and represent costs incurred in relation to the Kineta Merger.
General and Administrative Expenses. General and administrative expenses were $7.4 million and $8.4 million for the years ended December 31, 2025, and 2024, respectively. The increase of $7.0 million was primarily due to increases in non-cash stock compensation expense, and costs associated with being a public company.
Employee Retention Tax Credit. The IRS provided a refundable tax credit for businesses that had employees that were affected during the COVID-19 pandemic. In October 2022, we applied for a credit under this program and we received a credit $0.1 million in 2025.
Grant Income. Grant income was $0.7 million and less than $0.1 million for the years ended December 31, 2025 and 2024, respectively. In October 2024, we assumed the Kintara Health and Human Services grant on REM-001 and received reimbursements for related expenses associated with the grant.
Interest Expense. From December 2023 to September 2024, as part of our private placement financing under which we offered and sold convertible promissory note (the "TuHURA Notes"), we issued convertible notes totaling $31,253,000. The convertible notes included interest at 20% per annum, accretion to maturity date, and amortization of debt discount. Upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of our common stock at a conversion price $3.80 per share of our common stock. There was no cash paid for interest in the TuHURA Notes. In October 2024, we entered into a loan agreement with an accredited investor and shareholder for an aggregate principal amount of $3,000,000 incurring interest at 3%, lender warrants, and a loan fee of $180,000.
Interest Income. For the years ended December 31, 2025 and 2024, respectively, interest income was earned on deposits at various banks.
Change in Fair Value of Derivative Liability. For the year ended December 31, 2024, there was a loss of $0.3 million associated with the bifurcated embedded derivative liability related to the make-whole premium on the TuHURA Notes.
Change in Fair Value of Kineta Merger Holdback Shares. For the year ended December 31, 2025, there was a gain of $1.6 million associated with the Kineta Merger holdback shares due to a decrease in the share price in comparison to the date of the closing of the Kineta Merger.
Loss on Kineta Employee Separation Payments. In August 2025 we issued shares to former Kineta employees for separation payments assumed in the Kineta Merger resulting in a loss on settlement of $0.2 million.
Series A Preferred Cash Dividend- The holder of our the Series A Preferred Stock received dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
Deemed Dividend on Warrant Modifications - For the year ended December 31, 2024, there was a $1.0 million deemed dividend due to extending the exercise period on certain of our warrants for an additional six months.
Liquidity and Capital Resources
We have incurred net losses and negative cash flows from operations since our inception and we anticipate that we will continue to incur net losses for the foreseeable future. We incurred net losses of $30.1 million and $21.7 million for the years ended December 31, 2025 and 2024, respectively, and used $27.6 million and $14.7 million of cash from our operating activities for the years ended December 31, 2025, and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $141.2 million.
As of December 31, 2025, we had cash and cash equivalents of $3.6 million.
Sources of Liquidity
To date, we have financed our operations principally through the issuance of our capital stock, warrants and debt instruments. Since inception, Legacy TuHURA and the Company have raised approximately $99.7 million in net proceeds through the issuance and sale of capital stock, warrants and debt instruments
Warrant Exercise Notes
On February 12, 2025, four holders (the "Makers") of common stock purchase warrants of the Company made and issued to the Company secured promissory notes (the "Warrant Exercise Notes") in the aggregate principal amount of $3,011,373 as payment of the exercise price of an aggregate of 1,034,836 Warrants held by the Makers. The Makers were comprised of KP Biotech Group, LLC, CA Patel F&F Investments, LLC, Dr. Kiran C. Patel and Donald Wojnowski. Upon the exercise of such warrants, the Company issued to the Makers an aggregate of 1,034,836 shares of common stock. The amounts due under the Warrant Exercise Notes were collected in full in the second quarter of 2025.
Securities Purchase Agreement
On June 2, 2025, the Company and the Private Placement Purchasers entered into the Securities Purchase Agreement pursuant to which the Company agreed to issue and sell to the Private Placement Purchasers, in a private placement, an aggregate of 4,759,309 shares of the Company's common stock, together with the Private Placement Warrants, for an aggregate offering amount of $12.6 million. The combined effective offering price for each share and accompanying Private Placement Warrant in the Private Placement was $2.65.
On December 9, 2025, the Company entered into the Purchase Agreement with the "Purchasers. The Purchase Agreement relates to the sale and issuance in a registered direct offering by the Company of an aggregate of: (i) 9,462,423 shares of the Company's common stock, (ii) Series A Warrants to purchase up to 9,462,423 shares of common stock, and (iii) Series B Warrants to purchase up to 9,462,423 shares of common stock. The offering price for each share of common stock and accompanying Series A Warrant and Series B Warrant was $1.65. Each Common Warrant has an exercise price of $1.95 per share and is exercisable beginning six months after the date of issuance.
Cash Flows
The following table sets forth a summary of the net cash flow activity for the years ended December 31, 2025 and 2024, respectively:
|
Year Ended |
||||||||
|
December 31, |
||||||||
|
2025 |
2024 |
|||||||
|
Net cash provided by (used in): |
||||||||
|
Operating activities |
$ |
(27,629,150 |
) |
$ |
(14,728,138 |
) |
||
|
Investing activities |
(1,335,361 |
) |
(6,052,409 |
) |
||||
|
Financing activities |
19,927,282 |
29,772,693 |
||||||
|
Net increase (decrease) in cash |
$ |
(9,037,229 |
) |
$ |
8,992,146 |
|||
Operating Activities
For the year ended December 31, 2025, net cash used in operating activities was $27.6 million, which primarily consisted of a net loss of $30.1 million, a change in net operating assets and liabilities of $3.1 million, and net non-cash charges of $5.6 million. The net non-cash charges were primarily related to a $1.6 million change in fair value of holdback shares, amortization of debt discount of $0.5 million, depreciation and amortization expense of $0.1 million, and stock-based compensation of $6.4 million. The $3.1 million net change in operating assets and liabilities is primarily due to decreases in accounts payable and accrued expenses of approximately $3.8 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately $0.6 million.
For the year ended December 31, 2024, net cash used in operating activities was $14.7 million, which primarily consisted of a net loss of $21.7 million, a change in net operating assets and liabilities of $3.3 million, and net non-cash charges of $3.7 million. The net non-cash charges were primarily related to a $0.3 million change in fair value of derivative liability, amortization of debt discount of $1.3 million, depreciation and amortization expense of $0.1 million, and stock-based compensation of $2.0 million. The $3.3 million net change in operating assets and liabilities is primarily due to increases in accounts payable and accrued expenses of approximately $3.6 million due to timing of invoices and vendor payments, and a decrease in current and non-current assets of approximately $0.3 million.
Investing Activities
For the year ended December 31, 2025, net cash used in investing activities was $1.3 million, which consisted of purchases of property and equipment and deposits and exclusivity payments in connection with the Kineta Merger.
For the year ended December 31, 2024, net cash used in investing activities was $6.1 million, which consisted of purchases of property and equipment and deposits and exclusivity payments in connection with the Kineta Merger.
Financing Activities
For the year ended December 31, 2025, net cash provided by financing activities was $20.0 million, which consisted of $18.4 million net proceeds from the Private Placement in June 2025 and the Offering in December 2025, $3.0 million gross proceeds from the TuHURA bridge loan financing, and $3.6 million proceeds from the Legacy TuHURA warrants exercises, offset by $1.1 million payment in merger transaction costs and net liabilities attributable to Kintara, $3.2 million payment of the TuHURA bridge loan financing, $0.5 million payment of notes payable to former Kineta employees for separation payments assumed from the merger, and $0.4 million payment of Kineta debt assumed from the Kineta Merger.
For the year ended December 31, 2024, net cash provided by financing activities was $29.8 million, which consisted of $27.5 million net proceeds from convertible notes issued as part of the TuHURA Note Financing, $4.7 million net proceeds from the Legacy TuHURA private placement in July 2024, and $2.0 million proceeds from stock options and warrants exercises, offset by $4.4 million payment in merger transaction costs and net liabilities attributable to Kintara.
Funding Requirements
We expect to incur costs associated with operating as a public company. In addition, we anticipate that we will need substantial additional funding in connection with our development programs and continuing operations. We believe that our existing cash and cash equivalents, together with the ATM and the proceeds received in the Offering, will be sufficient to meet our anticipated cash requirements through the second quarter and into the third quarter of 2026.
Our forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. Management based projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may deplete our available capital resources sooner than management expects. Our future capital requirements will depend on many factors, including:
Until such time, if ever, as we can generate substantial product revenues to support our capital requirements, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, collaborations and licensing arrangements or other capital sources. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders of our common stock. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may need to relinquish valuable rights to our product candidates, future revenue streams or
research programs or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings as and when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Critical Accounting Policies and Significant Judgments and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors 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 that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in Note 2 of our consolidated financial statements for the year ended December 31, 2025, contained in Item 8 in this Annual Report, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
Stock-Based Compensation Expense
Stock-based compensation expense represents the cost of the grant date fair value of equity awards recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. we estimate the fair value of equity awards using the Black-Scholes option pricing model and recognizes forfeitures as they occur. Estimating the fair value of equity awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of variables, including the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop. See Note 2 of our financial statements for information concerning certain of the specific assumptions we use in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted.
Kineta Acquisition and Valuation of Intangible Assets
On June 30, 2025 we completed the Kineta Merger contemplated by the TuHURA-Kineta Merger Agreement, pursuant to which the Company acquired Kineta in a cash and stock transaction through a series of merger transactions, with Kineta surviving the mergers as a wholly-owned subsidiary of ours.
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Kineta Share issued and outstanding immediately prior to the First Merger, was converted into the right to receive 0.185298 shares of our common stock for an aggregate of approximately 2,868,169 shares of our common stock. Also pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Kineta Share received its pro rata portion of approximately 1,129,880 shares of our common stock in December 2025, in accordance with the terms of the TuHURA-Kineta Merger Agreement. In addition, each Kineta Share is entitled to the right to its pro rata share of cash consideration received by Kineta pursuant to disposed asset payments related to legacy Kineta assets. Such payments, if any, will be made at a later date and in accordance with the terms of the TuHURA-Kineta Merger Agreement. In each case, in lieu of the issuance of any fractional shares of our common stock, we will pay an amount equal to the product of (A) such fractional share and (B) $5.7528.
The estimated fair value of the aggregate share component of the Kineta Merger was calculated using the closing stock price on the date of the Kineta Merger.
We recognized in-process research and development ("IPR&D") in connection with the acquisition. The preliminary fair value of the acquired IPR&D intangible assets was determined based on the market capitalization of Kineta, as previously traded on the Nasdaq capital market.
Goodwill and other intangible assets comprised of IPR&D on our balance sheet as of December 31, 2025 were in connection with the Kineta Merger.
In a business combination, the fair value of acquired IPR&D is capitalized and accounted for as indefinite-lived intangible assets, and not amortized until the underlying project receives regulatory approval, at which point the intangible assets will be accounted for as definite-lived intangible assets or discontinued. If discontinued, the intangible assets will be written off. R&D costs incurred after the acquisition are expensed as incurred.
We will engage a third-party valuation firm to assist us with the valuation of the IPR&D. The valuation of our acquired IPR&D has significant measurement uncertainty given the lack of historical data on which to base assumptions. Assumptions are difficult to make accurately and were mainly derived from life science studies, industry data, and peer company information that our management believes represent appropriate comparable data.
We test indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If we conclude it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed.
Recently Issued and Adopted Accounting Pronouncements
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our financial statements.
Off-Balance Sheet Arrangements
During the periods presented, we do not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.