11/14/2025 | Press release | Distributed by Public on 11/14/2025 06:21
Item 2. 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 condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and audited consolidated financial statements in the Annual Report on Form 10-K filed with the SEC on March 31, 2025 (the "2024 Annual Report"). 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 Quarterly Report on Form 10-Q, as well as those set forth under the heading "Risk Factors" in Part I. Item 1A in the 2024 Annual Report, 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 "Special Note Regarding Forward-Looking Statements".
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the three and nine months ended September 30, 2025 compared to the three and nine months ended September 30, 2024. References to periods prior to the closing of the Kintara Merger refer to Legacy TuHURA, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc "Kintara") for all other periods, as the context requires.
Overview
TuHURA Biosciences, Inc., a Nevada corporation ("we," "our", "TuHURA," or the "Company"), is a clinical-stage immuno-oncology company with three distinct technologies focused on the development of novel therapeutics 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, Inc. ("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.
In addition to our IFx and TBS-2025 technologies, we are leveraging our Delta Opioid Receptor technology to develop tumor microenvironment modulators in the form of first-in-class bi-specific antibody-peptide conjugates ("APCs") and antibody-drug conjugates ("ADCs") targeting Myeloid Derived Suppressor Cells ("MDSCs"). Our APCs and ADCs are being developed to inhibit the immune-suppressing effects of MDSCs on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
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 private placement of capital stock and convertible notes.
We are not profitable and has incurred significant operating losses in each period since its inception, our net losses were $22.6 million for the year ended December 31, 2024 and $29.3 million for the year ended December 31, 2023 (which includes the expensing of the entire $16.2 million purchase price for the assets of TuHURA Biopharma, Inc. ("TuHURA Biopharma"), of which $15.0 million was paid in the form of Legacy TuHURA common stock), and $23.3 million and $15.7 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $134.4 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. Furthermore, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations, compliance and other expenses that we did not previously incur as a private company.
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 September 30, 2025, we had cash and cash equivalents of $2.7 million. See " - Liquidity and Capital Resources" below.
Recent Developments
June 2025 Private Placement
On June 2, 2025, we entered into with certain accredited investors (the "Purchasers") a securities purchase agreement (the "Securities Purchase Agreement") pursuant to which we agreed to issue to the Purchasers, in a private placement (the "Offering"), 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 "Warrants"), for an aggregate offering amount of approximately $12.6 million. The combined effective offering price for each share and accompanying Warrant in the Offering was $2.65. The Warrants have an exercise price per share equal to $3.3125 and will expire on the fifth (5th) anniversary of December 3, 2025. The exercise price of the Warrants is subject to proportional adjustment for stock splits, reverse stock splits, and similar transactions.
Pursuant to the Securities Purchase Agreement, each Purchaser was obligated to purchase such Purchaser's respective investment in the Offering in four equal tranches, as follows:
• $2.23 million was purchased on June 2, 2025 (the "Initial Closing");
• $2.23 million was purchased on June 9, 2025, following our notification to the Purchasers that the Food and Drug Administration (FDA) has notified us that we are no longer subject to the partial clinical hold set forth in the FDA's Partial Clinical Hold letter to us dated January 24, 2024, with respect to our planned Phase 3 trial of IFx-2.0;
• $2.23 million was purchased on June 24, 2025, following our notification to the Purchasers that the
Phase 3 trial for IFx-Hu2.0 (the "Phase 3 Trial") had been initiated; and
• $2.23 million was purchased on June 30, 2025, following our notification to the Purchasers that all material conditions for the closing of our merger transaction with Kineta have been satisfied (other than conditions that cannot be satisfied until on or immediately before the closing of the Kineta Merger) and that we were prepared to close the Kineta Merger.
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 Offering (the "Final Tranche Offering Amount") was required to be purchased and funded by December 31, 2025 by certain Purchasers who agreed to invest an aggregate of $4.0 million or more in the Offering and who elected to defer the purchase of a portion of such Purchaser's common stock and Warrants until such time (the "Derral 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"). As of September 30, 2025, an aggregate of $0.5 million remains outstanding in the Final Tranche Offering Amount to be purchased on or before December 31, 2025. Under the Warrant Amendment Agreements, the expiration dates of the 2024 Warrants was extended to December 31, 2030.
In connection with the Offering and the sale of shares of common stock and Warrants to purchase common stock sold to the Purchasers pursuant to the Securities Purchase Agreement, the Company filed a registration statement on Form S-1 (the "Resale Registration Statement"), including the prospectus therein, relating to the resale of the common stock and shares of common stock underlying the Warrants from time to time purchased by the selling stockholders named therein pursuant to the Securities Purchase Agreement. The Resale Registration Statement was declared effective by the Securities and Exchange Commission on September 26, 2025.
Closing of Kineta Merger
On June 30, 2025, we 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 us, Hura Merger Sub I, Inc., a Delaware corporation and a direct wholly-owned subsidiary of ours ("Merger Sub I"), Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of ours ("Merger Sub II"), Kineta, 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 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 "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 Share is also entitled to (i) its pro rata portion of approximately 1,129,885 shares of our common stock to be issued after six months following the closing of the Kineta Merger, subject to adjustment for losses incurred or accrued during the six month period from the closing of the Kineta Merger, and (ii) 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.
Bridge Loan Transaction
On October 27, 2025, the Company entered into a Secured Promissory Note and Loan Agreement (the "Loan Agreement") with an accredited investor and shareholder of the Company (the "Lender"). Pursuant to the terms of the Loan Agreement, the Lender agreed to make loans to the Company in an aggregate principal amount of up to $3,000,000 (the "Loans") during a 30-day availability period beginning on the date of the Loan Agreement. The Lender advanced the first loan to the Company in the amount of $1,500,000 simultaneously with the execution of the Loan Agreement (the "Initial Advance"), and upon advance notice by the Company in accordance with the terms therein, may loan up to an additional $1,500,000. The Loans will be used by the Company for working capital purposes. The interest rate on the loan agreement is 3.0% and has a maturity date of December 31, 2025. In addition, on the date of the Initial Advance, the Company issued to the Lender an aggregate of 65,217 shares of common stock (the "Lender Warrant"). The Lender Warrant is immediately exercisable and will expire on the date that is two years from the date of issuance.
Registration Statement on Form S-3 and 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. The shares of common stock to be offered and sold under the Offering Agreement will be sold pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-219239), which was filed with the SEC on November 3, 2025 (the "Shelf Registration Statement"). A prospectus supplement related to the at the market offering program was filed as part of the Shelf Registration Statement. As of the date of this Quarterly Report on Form 10-Q, the Shelf Registration Statement has not been declared effective by
the SEC. No shares of common stock may be sold pursuant to the Offering Agreement until the Shelf Registration Statement has been declared effective by the SEC.
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, 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:
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. We also anticipate increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums and investor relations costs associated with operating as a public company.
Other Income (Expense)
Other income (expense) consists of other expense on share settlement of Kineta merger separation payments, interest income on our cash and cash equivalents, interest expense on borrowings under our convertible notes and issued notes payable to the former Kineta employees, grant income from our NIH-funded research grant assumed in the Kintara Merger in October 2024, and non-cash changes in the fair value of our derivative liability associated with the make-whole premium on our convertible notes and our Kineta Merger holdback shares.
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 (the "Series A Warrants") 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 Three Months Ended September 30, 2025, and September 30, 2024
|
Three months ended |
||||||||||||
|
September 30, |
Change |
|||||||||||
|
2025 |
2024 |
|||||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
$ |
4,968,596 |
$ |
2,946,768 |
$ |
2,021,828 |
||||||
|
General and administrative |
1,761,007 |
783,459 |
977,548 |
|||||||||
|
Total operating expenses |
6,729,603 |
3,730,227 |
2,999,376 |
|||||||||
|
Loss from operations |
(6,729,603 |
) |
(3,730,227 |
) |
(2,999,376 |
) |
||||||
|
Other income (expense) |
||||||||||||
|
Grant income |
138,299 |
- |
138,299 |
|||||||||
|
Interest expense |
(16,532 |
) |
(2,002,886 |
) |
1,986,354 |
|||||||
|
Interest income |
6,060 |
132,767 |
(126,707 |
) |
||||||||
|
Other expense |
(185,019 |
) |
- |
(185,019 |
) |
|||||||
|
Change in fair value of Kineta merger holdback liability |
(315,660 |
) |
- |
(315,660 |
) |
|||||||
|
Change in fair value of derivative liability |
- |
21,229 |
(21,229 |
) |
||||||||
|
Total other income (expense) |
(372,852 |
) |
(1,848,890 |
) |
1,476,038 |
|||||||
|
Net loss |
$ |
(7,102,455 |
) |
$ |
(5,579,117 |
) |
$ |
(1,523,338 |
) |
|||
|
Series A Preferred cash dividend |
(2,089 |
) |
- |
(2,089 |
) |
|||||||
|
Warrant modification |
- |
(965,177 |
) |
965,177 |
||||||||
|
Net loss attributable to common shareholders |
$ |
(7,104,544 |
) |
$ |
(6,544,294 |
) |
$ |
(560,250 |
) |
|||
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
|
Three months ended |
||||||||||||
|
September 30, |
Change |
|||||||||||
|
2025 |
2024 |
|||||||||||
|
Direct program costs: |
||||||||||||
|
IFx-2.0 |
$ |
1,567,077 |
$ |
1,421,233 |
$ |
145,844 |
||||||
|
TBS-2025 |
317,340 |
- |
317,340 |
|||||||||
|
Preclinical research costs |
580,904 |
377,537 |
203,367 |
|||||||||
|
Indirect program costs: |
||||||||||||
|
Personnel and facilities related costs |
2,503,275 |
1,147,999 |
1,355,276 |
|||||||||
|
Total research and development expenses |
$ |
4,968,596 |
$ |
2,946,769 |
$ |
2,021,827 |
||||||
Research and development expenses were $5.0 million and $2.9 million for the three months ended September 30, 2025, and 2024, respectively. The increase of $2.1 million related to the following.
General and Administrative Expenses. General and administrative expenses were $1.8 million and $0.8 million for the three months ended September 30, 2025, and 2024, respectively. The increase of $1.0 million was primarily due to increases in non-cash stock compensation expense, merger transaction costs related to the Kineta acquisition, and costs associated with being a public company.
Grant Income. Grant income was $0.1 million for the three months ended September 30, 2025. 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. Interest expense was $2.0 million for the three months ended September 30, 2024. 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 $31.3 million. The TuHURA 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. Interest expense was less than $0.1 million for the three months ended September 30, 2025 due to interest on the issued notes payable to former Kineta employees.
Interest Income. Interest income was less than $0.1 million and $0.1 million for the three months ended September 30, 2025 and 2024, respectively, related primarily to interest income earned on deposits at various banks.
Other Expense. Other expense was $0.2 million for the three months ended September 30, 2025, related to share settlement in exchange for a portion of the separation payments to the former Kineta employees assumed from the merger.
Change in Fair Value of Derivative Liability. For the three months ended September 30, 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 Liability. For the three months ended September 30, 2025, there was a loss of $0.3 million associated with the holdback shares from the Kineta merger and due to the increase in share price in comparison to the merger date.
Preferred Stock Series A Cash Dividend. The holder of our Series A Preferred Stock received cash dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
Warrant Modification.For the three months ended September 30, 2024, there was a $1.0 million deemed dividend due to extending the exercise period on certain of the Series A Warrants for an additional six months.
Comparisons for the Nine Months Ended September 30, 2025, and September 30, 2024
|
Nine months ended |
||||||||||||
|
September 30, |
Change |
|||||||||||
|
2025 |
2024 |
|||||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
$ |
14,477,204 |
$ |
9,358,845 |
$ |
5,118,359 |
||||||
|
General and administrative |
9,145,378 |
2,595,860 |
6,549,518 |
|||||||||
|
Total operating expenses |
23,622,582 |
11,954,705 |
11,667,877 |
|||||||||
|
Loss from operations |
(23,622,582 |
) |
(11,954,705 |
) |
(11,667,877 |
) |
||||||
|
Other income (expense) |
||||||||||||
|
Grant income |
713,508 |
- |
713,508 |
|||||||||
|
Interest expense |
(16,532 |
) |
(3,615,466 |
) |
3,598,934 |
|||||||
|
Interest income |
135,624 |
197,449 |
(61,825 |
) |
||||||||
|
Other expense |
(185,019 |
) |
- |
(185,019 |
) |
|||||||
|
Change in fair value of Kineta merger holdback shares |
(315,660 |
) |
- |
(315,660 |
) |
|||||||
|
Change in fair value of derivative liability |
- |
(313,772 |
) |
313,772 |
||||||||
|
Total other income (expense) |
331,921 |
(3,731,789 |
) |
4,063,710 |
||||||||
|
Net loss |
$ |
(23,290,661 |
) |
$ |
(15,686,494 |
) |
$ |
(7,604,167 |
) |
|||
|
Series A Preferred cash dividend |
(6,267 |
) |
- |
(6,267 |
) |
|||||||
|
Warrant modification |
- |
(965,177 |
) |
965,177 |
||||||||
|
Net loss attributable to common shareholders |
$ |
(23,296,928 |
) |
$ |
(16,651,671 |
) |
$ |
(6,645,257 |
) |
|||
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
|
Nine months ended |
||||||||||||
|
September 30, |
Change |
|||||||||||
|
2025 |
2024 |
|||||||||||
|
Direct program costs: |
||||||||||||
|
IFx-2.0 |
$ |
5,647,463 |
$ |
5,192,858 |
$ |
454,605 |
||||||
|
TBS-2025 |
317,340 |
- |
317,340 |
|||||||||
|
Preclinical research costs |
1,599,950 |
817,373 |
782,577 |
|||||||||
|
Indirect program costs: |
||||||||||||
|
Personnel and facilities related costs |
6,912,451 |
3,348,615 |
3,563,836 |
|||||||||
|
Total research and development expenses |
$ |
14,477,204 |
$ |
9,358,846 |
$ |
5,118,358 |
||||||
Research and development expenses were $14.5 million and $9.4 million for the nine months ended September 30, 2025, and 2024, respectively. The increase of $5.1 million related to the following.
General and Administrative Expenses. General and administrative expenses were $9.1 million and $2.6 million for the nine months ended September 30, 2025, and 2024, respectively. The increase of $6.5 million was primarily due to increases in non-cash stock compensation expense, merger transaction costs related to the Kineta acquisition, and costs associated with being a public company.
Grant Income. Grant income was $0.7 million for the nine months ended September 30, 2025. 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. Interest expense was $3.6 million for the nine months ended September 30, 2024. 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 $31.3 million. The TuHURA 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. Interest expense was less than $0.1 million for the nine months ended September 30, 2025 due to interest on the issued notes payable to former Kineta employees.
Interest Income. Interest income was $0.1 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively, related primarily to interest income earned on deposits at various banks.
Change in fair value of Kineta merger holdback liability. For the nine months ended September 30, 2025, there was a loss of $0.3 million associated with the holdback shares from the Kineta merger and due to the increase in share price in comparison to the merger date.
Preferred Stock Series A cash dividend. The holder of our Series A Preferred Stock received cash dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
Warrant modification.For the nine months ended September 30, 2024, there was a $1.0 million deemed dividend due to extending the exercise period on certain of the Series A 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 $22.6 million and $29.3 million for the years ended December 31, 2024, and 2023, respectively, and incurred net losses of $23.3 and $15.7 million for the nine months ended September 30, 2025 and 2024, respectively. Additionally, we used $14.7 million and $12.0 million of cash from our operating activities for the years ended December 31, 2024, and 2023, respectively, and used $22.1 million and $12.1 million from our operating activities for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $134.4 million.
As of September 30, 2025, we had cash and cash equivalents of $2.7 million. In October 2025, we received $1.5 million in a bridge loan financing with the Lender. We invest our cash and cash equivalents in liquid money market accounts.
Sources of Liquidity
To date, we have financed our operations principally through private placements of our common and preferred stock (which, in the case of Legacy TuHURA, have all since been converted into shares of Legacy TuHURA common stock and exchanged for shares of Kintara common stock in connection with the completion of the Kintara Merger) and issuance of convertible notes that were converted into Legacy TuHURA common stock prior the Kintara Merger). Since inception, Legacy TuHURA has raised approximately $41.6 million in net proceeds through the sale of its preferred stock and approximately $36.0 million in aggregate principal amount through the issuance of convertible notes. Since the Kintara Merger, TuHURA has raised approximately $13.6 million in aggregate principal amount through the issuance of common stock and bridge financings.
Warrant Exercise Notes
On February 12, 2025, four holders (the "Makers") of common stock purchase warrants (the "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 the Warrants, the Company issued to the Makers an aggregate of 1,034,836 Warrant Shares, all of which are "restricted securities" within the meaning of the federal securities laws. 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 Purchasers entered into the Securities Purchase Agreement pursuant to which the Company agreed to issue and sell to the Purchasers, in a private placement, an aggregate of 4,759,309 shares of the Company's common stock, together with warrants to purchase an equal number of shares of common stock at an exercise price of $3.3125 (the "Warrants"), for an aggregate offering amount of $12,612,169. The combined effective offering price for each share and accompanying Warrant in the Offering was $2.65.
Cash Flows
The following table sets forth a summary of the net cash flow activity for the nine months ended September 30, 2025 and 2024, respectively:
|
Nine Months Ended |
||||||||
|
September 30, |
||||||||
|
2025 |
2024 |
|||||||
|
Net cash provided by (used in): |
||||||||
|
Operating activities |
$ |
(22,073,128 |
) |
$ |
(12,128,521 |
) |
||
|
Investing activities |
(1,307,511 |
) |
(5,228,869 |
) |
||||
|
Financing activities |
13,420,877 |
33,288,380 |
||||||
|
Net increase (decrease) in cash |
$ |
(9,959,762 |
) |
$ |
15,930,990 |
|||
Operating Activities
For the nine months ended September 30, 2025, net cash used in operating activities was $22.1 million, which primarily consisted of a net loss of $23.3 million, a change in net operating assets and liabilities of $3.6 million, and non-cash charges of $4.8 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, a change in fair value of the Kineta Merger holdback shares of $0.3 million, loss on share settlement of Kineta assumed liabilities of $0.2 million, and stock-based compensation of $4.3 million. The $3.6 million net change in operating assets and liabilities is primarily due to decrease in accounts payable and accrued expenses of approximately $3.9 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately $0.3 million.
For the nine months ended September 30, 2024, net cash used in operating activities was $12.1 million, which primarily consisted of a net loss of $15.7 million and a change in net operating assets and liabilities of $1.2 million, and non-cash charges of $2.4 million. The net non-cash charges were primarily related, depreciation and amortization expense of $0.1 million, stock-based compensation of $0.9 million, amortization of debt discount and change in fair value of the derivative liability of $1.4 million associated with the TuHURA Note Financing. The $1.2 million change in net operating assets and liabilities was due to an increase in accounts payable and accrued expenses of approximately $1.3 million due to timing of invoices and vendor payments, and a decrease in current and non-current assets of $0.1 million.
Investing Activities
For the nine months ended September 30, 2025 and 2024, net cash used in investing activities was $1.3 million and $5.2 million, which consisted of purchases of property and equipment and deposits and payments in connection with the Kineta acquisition.
Financing Activities
For the nine months ended September 30, 2025, net cash provided by financing activities was $13.4 million, which consisted of $3.6 million proceeds from warrants exercises, $12.1 million in gross proceeds from the issuance of common stock attributable to the Offering, offset by $0.7 million in payments for deferred offering costs attributable to the Offering, $0.4 million of debt assumed from the Kineta Merger, $0.1 million principal payment of note payables to former Kineta employees, and $1.1 million in merger transaction costs and net liabilities attributable to Kintara.
For the nine months ended September 30, 2024, net cash provided by financing activities was $33.3 million, which consisted of $27.5 net proceeds from convertible notes issued as part of the TuHURA Note Financing, $4.7 million net proceeds from the common stock private offering, $2.0 million proceeds from stock options and warrants exercises, and $0.9 million in deferred offering costs paid in connection with the Kintara Merger.
Funding Requirements
We expect to incur additional 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 payment of the Warrant Exercise Notes, bridge loan transaction, and the financing from the Securities Purchase Agreement with the accredited investors, will be sufficient to meet our anticipated cash requirements through the end of 2025.
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 condensed consolidated financial statements for the three months ended September 30, 2025, contained in Item 1 in this Quarterly Report, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
Accrued Research and Development Expenses
As part of the process of preparing our financial statements, we are required to estimate our accrued expenses as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our accrued expenses as of each balance sheet date based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and adjusts, if necessary. The significant estimates in our accrued research and development expenses include the costs incurred for services performed by our vendors in connection with research and development activities for which we have not yet been invoiced.
We base our expenses related to research and development activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct research and development on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract-to-contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid expense accordingly. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.
Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting
our that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred.
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.
Common Stock Valuations
We are required to estimate the fair value of the common stock underlying our equity awards when performing fair value calculations. The fair value of the common stock underlying our equity awards was determined on each grant taking into account input from management and taking into account the pricing offered in our equity raises. All options to purchase shares of our common stock are intended to be granted with an exercise price per share no less than the fair value per share of our common stock underlying those options on the date of grant, based on the information known to us on the date of grant. In the absence of a public trading market for our common stock, on each grant date we develop an estimate of the fair value of our common stock in order to determine an exercise price for the option grants. Our determination of the fair value of our common stock was made by considering the prices of preferred stock sold to investors in arm's length transactions and the rights, preferences and privileges of our preferred stock relative to those of our common stock.
In determining the fair value of shares of our underlying stock option grants prior to our reverse merger with Kintara, for the three months ended September 30, 2024, we used the market approach by reference to the closest round of equity financing, preceding the date of valuation and analysis of the trading values of publicly traded companies deemed comparable to us.
Following our reverse merger with Kintara, the fair value of our common stock will be determined based on the quoted market price of our common stock. In connection with our reverse merger with Kintara, all outstanding shares of our preferred stock were converted into shares of our common stock.
Kineta Acquisition and Valuation of Intangible Assets
On June 30, 2025 we completed the business combination 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 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 Share is also entitled to (i) its pro rata portion of approximately 1,129,885 shares of our common stock to be issued after six months following the closing of the Kineta Merger, subject to adjustment for losses incurred or accrued during the six month period from the closing of the Kineta Merger, and (ii) 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 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 September 30, 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.