HURA 10-K & 10-Q changes, risk factors and insider trading

LegacyWe TuHURA, our main operating subsidiary, hashave incurred significant losses since inception and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future.

LegacyWe TuHURA isare not profitable and has incurred significant losses in each period since its inception, including net losses of $22.6$30.1 million for the year ended December 31, 2024,2025, and $29.3$21.7 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, of which $15.0 million was paid in the form of our common stock).2024. To date, we have financed our operations primarily through registered direct offerings, private placements of our common and preferred stockstock, and convertible notes. We have not commercialized any products and hashave never generated any revenue from product sales. We expect these losses to increase as itwe continuescontinue to incur significant research and development and other expenses related to our ongoing operations, seeks regulatory approvals for our product candidates, scales-up manufacturing capabilities and hires additional personnel to support the development of our product candidates and to enhance our operational, financial and information management systems.

Our operations have required substantial amounts of cash since inception. We expect to continue to spend substantial amounts to continue the clinical development of our product candidates, particularly as we advance the development of our product candidates, including our lead product candidate Ifx-Hu2.0 as a potential treatment for patients with melanoma, bladder and cervical cancers.cancers and TBS-2025, our VISTA inhibiting antibody. If we obtain orphan drug designation and marketing approval for Ifx-Hu2.0 or any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.

As of December 31, 2024,2025, we had cash and cash equivalents of $12.7$3.6 million. Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments, together with the anticipated$7.0 paymentmillion ofreceived notesin receivablethe first quarter from warrantthe exercises,December 2025 registered direct offering, should be sufficient to fund our operations through lateearly fourththird quarter of 2025.2026. This estimate is based on assumptions that may prove to be materially wrong, and we could use our available capital resources sooner than itwe currently expectsexpect because of circumstances beyond our control. We may require additional capital for the further development and commercialization of our product candidates and may need to raise additional funds sooner if we choose to pursue additional indications or geographies for our product candidates or otherwise expand more rapidly than we presently anticipate. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.

We cannot be certain that additional funding will be available on acceptable terms, or at all. Our ability to raise additional funding will depend on financial, economic and market conditions and other factors, over which we may have no or limited control. In addition, our ability to obtain future funding when needed through equity financings, debt financings or strategic collaborations may be particularly challenging in light of the uncertainties and circumstances resulting from the ongoing military conflict between Russian and Ukraine, as well as the ongoing conflict between Israel and Hamas, as well as the recent United States and Israeli air-based military campaigns in Iran, and the global impacts of such conflicts. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives. Our license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under the agreements. We could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercialization ourself.

Our near-term ability to generate product revenue is highly dependent on our ability to obtain regulatory approval of and successfully commercialize one or more of our product candidates. IFx-2.0 and IFx-Hu3.0TBS-2025 are in late and early stages, respectively, of development and will require additional clinical and nonclinical development, regulatory review, and approval in each jurisdiction in which we intend to market the products, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before we can generate any revenue from product sales. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety, purity, and potency of the product candidates in humans. We cannot be certain that any of our product candidates will be successful in clinical trials and they may not receive regulatory approval even if they are successful in clinical trials.

If we are unable to address one or more of these factors in a timely manner or at all, we could experience significant delays in the successful commercialization of, or an inability to successfully commercialize, our product candidates, which would materially harm our business. If we do not receive regulatory approvals for one or more of our product candidates, we may not be able to continue our operations. Even if we successfully obtains regulatory approvals to manufacture and market our product candidates, our revenues will be dependent, in part, upon the size of the markets in the territories for which it gains regulatory approval and hashave commercial rights. If the markets for patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products, if approved.

The FDA standard for regular approval of a biologic generally requires two well-controlled phasePhase 3 studies or one large and robust, well-controlled phasePhase 3 study in the patient population being studied that provides substantial evidence that a biologic is safe and effective for its proposed indication. Phase 3 clinical trials typically involve hundreds of patients, have significant costs, and take years to complete. Product candidates studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA may require a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals. Recently, we entered into athe SPA agreement with the FDA for a single Phase 3 randomized placebo and injection controlled trial for IFx-2.0,IFx-2.0. whichWe we believe will lead to initiation ofinitiated the Phase 3 studytrial in of the second quarter ofJune 2025. If our efforts to obtain approval for IFx-2.0 or any other product candidate is not successful, then we may be required to conduct additional clinical trials beyond those weit contemplate,contemplates, which would likely result in a longer time period to potential approval and commercialization of such product candidate (if approved) and would likely increase the cost of development of such product candidate, all of which could harm the Company’scompany’s competitive position in the marketplace and shorten the remaining term of applicable patent coverage after product approval.

Any agreements governing our relationships with CROs or other contractors with whom we currently engagesengage or may engage in the future may provide those outside contractors with certain rights to terminate a clinical trial under specified circumstances. If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition, and prospects.

The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of drug products are, and will remain, subject to extensive regulation by the FDA in the United States and by the respective regulatory authorities in other countries where regulations differ. We are not permitted to market our biological product candidates in the United States until we receivesreceive the respective approval of a BLA from the FDA, or in any foreign countries until we receive the requisite approval from the respective regulatory authorities in such countries. The time required to obtain approval, if any, by the FDA, EMA and comparable foreign authorities is unpredictable, but typically takes many years following the commencement of clinical trials, if approval is obtained at all, and depends upon numerous factors, including the substantial discretion of the regulatory authorities and the type, complexity and novelty of the product candidates involved. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional nonclinical studies or clinical trials. We have limited experience in planning and conducting the clinical trials required for marketing approvals, and we have and expect to continue to rely on third-party CROs to assist us in this process. Obtaining marketing approval requires the submission of extensive nonclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process, and in many cases the inspection of manufacturing, processing, and packaging facilities by the regulatory authorities. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude us obtaining marketing approval or prevent or limit commercial use, or there may be deficiencies in cGMP compliance by us or by our CMOs that could result in the candidate not being approved. Moreover, we have not obtained regulatory approval for any drug candidate in any jurisdiction and it is possible that none of our existing drug candidates or any drug candidates we may seek to develop in the future will ever obtain regulatory approval.

We currently have no marketing and sales organization and hashave no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.

If we are unable or decide not to establish internal sales, marketing and commercial distribution capabilities for any or all products we develop, it will likely pursue collaborative arrangements regarding the sales and marketing of our products. However, there can be no assurance that we will be able to establish or maintain such collaborative arrangements, or if we are able to do so, that they will have effective sales forces. Any revenue we receive will depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the marketing and sales efforts of such third parties, and our revenue from product sales may be lower than if we had commercialized our product candidates itself.ourselves. We also face competition in our search for third parties to assist it with the sales and marketing efforts of our product candidates.

Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, and others in the medical community. Our products may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, and others in the medical community. Several factors will influence whether our product candidates are accepted in the market, including:

Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our business, financial condition, results of operations or prospects. Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably. Successful sales of our product candidates, if approved, depend on the availability of adequate coverage and reimbursement from third-party payors. In addition, because our product candidates represent new approaches to treat cancer and other immune-related diseases, we cannot accurately estimate the potential revenue from our product candidates.

We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that uswe or our employees, consultants, or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costcosts and be a distraction to our management and employees.

Even if we isare successful in achieving regulatory approval to commercialize a product candidate faster than our competitors, we may face competition from biosimilars. The Patient Protection and Affordable Care Act, which was signed into law in March 2010, included a subtitle called the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”). The BPCIA established a regulatory scheme authorizing the FDA to approve biosimilars and interchangeable biosimilars. While certain biosimilar products have been approved by the FDA for use in the United States, none of these have been cell therapy products and none have been interchangeable biosimilars. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars. Additional guidance is expected to be finalized by the FDA in the near term.

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates, and uncertainty about economic stability. For example, the COVID-19 pandemic resulted in widespread unemployment, economic slowdown, and extreme volatility in the capital markets. The Federal Reserve has raised interest rates multiple times in response to concerns about inflation and it may raise them again.

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, 2023.2023 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.gov as 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.

We are a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer immunotherapies. Our proprietary Immune FxTM technology 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. WeIn areJune preparing2025, towe initiateinitiated 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 Cellcell Carcinomacarcinoma who are checkpoint inhibitor naïve,naïve utilizing the FDA’s accelerated approval pathway. In addition to our innateIFx 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 agonistcheckpoint candidates,highly weexpressed areon leveragingmyeloid ourcells Deltathat receptoris technologybelieved to developbe tumora microenvironmentstrong modulators in the formdriver of first-in-classimmunosuppression 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 onin the tumor microenvironment and is believed to preventbe Ta cellprimary exhaustionmechanism by which leukemic blasts escape immune recognition contributing to low relapse rates and acquiredhigh resistancerates toof checkpointrecurrence inhibitorsin andacute cellularmyeloid therapies.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 private placementissuance of capital stockstock, warrants and convertible notes.

We are not profitable and has incurred significant operating losses in each period since itsour inception, including net losses of $22.6$30.1 million for the year ended December 31, 2024,2025, and $29.3$21.7 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, of which $15.0 million was paid in the form of Legacy TuHURA common stock).2024. As of December 31, 2024,2025, we had an accumulated deficit of $111.1$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. 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.

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). EachFollowing the achievement of certain prescribed milestones, each CVR shallreceived entitlein theDecember holder thereof to receive2025 its pro rata portion of 1,539,918 shares of TuHURA common stock if TuHURA achieves the following milestones: (i) TuHURA enrolls a minimum of ten cutaneous metastatic breast cancer patients in a study to determine whether a dose of TuHURA’s REM-001 lower than 1.2 mg/kg elicits a treatment effect similar to that seen in prior studies of REM-001 at the 1.2 mg/kg dose and (ii) such patients enrolled in the study complete eight weeks of follow-up, in each case, on or before December 31, 2025.stock.

To date, our research and development expenses have related primarily to the development of IFx-Hu2.0,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.

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) 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,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.notes Otherand incomeholdback (expense)shares also included grant income from our NIH-funded research grants completed in May 2023, employee retention tax credit for companies with employees affected duringon the COVID-19Kineta pandemic, and forgiveness of a paycheck protection program loan in April 2022.Merger.

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.

an increase of approximately $0.4$0.9 million due to preclinical research of IFx-3.0IFx-3.0, MDSCs and MDSCsREM-001; and an increase of approximately $1.9$4.6 million in facilities, salary and personnel related costs.

InterestAcquisition-related Income.costs. ForAcquisition related costs were $3.7.million and $0.4 million for the years ended December 31, 20242025, and 2023,2024, respectively, interestand incomerepresent wascosts earnedincurred onin depositsrelation atto variousthe banks.Kineta Merger.

Preferred Stock Series A cashPreferred dividendCash 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 modificationModifications – For the year ended December 31, 2024, there was a $1.0 million deemed dividend due to extending the exercise period on certain of theour Series A Warrantswarrants for an additional six months.

Except as set forth below, thereThere have been no material changes to the risk factors identified in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 31, 2026.2026 Factorsand that are not currently known to us, factors that we currently consider immaterial or factors that are not specific to us, such as general economic conditions, may also materially adversely affectin our businessQuarterly orReport financialon condition.Form 10-Q for the quarter ended March 31, 2026 which was filed with the SEC on April 14, 2026.

In this section, we discuss our financial condition, changes in financial condition and results of our operations for the three and six months ended MarchJune 31,30, 2026 compared to the three and six months ended MarchJune 31,30, 2025. References to periods prior to the closing of the Kintara Merger refer to Legacy TuHURA, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc.,Inc. (“Kintara”)) for all other periods, as the context requires.

We are a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer immunotherapies. Our proprietary Immune FxTM technology 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, IFx-2.0, 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 KVA12123, through our acquisition of Kineta, Inc. (“Kineta”) on June 30, 2025 (the “Kineta Merger”). 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 response 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 1b/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 debt financings, the issuance of capital stock, warrants and convertible notes.

We are not profitable and have incurred significant operating losses in each period since our inception, including net losses of $7.5$9.2 million and $16.8 million for the three and six months ended MarchJune 31,30, 2026, and $30.1 million for the year ended December 31, 2025. As of MarchJune 31,30, 2026, we had an accumulated deficit of $148.7$157.9 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 we advance our product candidates through preclinical and clinical development, develop additional product candidates and seek 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 obtain 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 itus 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.ourselves.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $6.3$1.0 million. See “ — Liquidity and Capital Resources” below.

On April 21, 2026, the Company entered into a Loan Agreement (the “Loan Agreement”) with Parkview Holdings One LLC (“Parkview”), an affiliate of K&V Investment LLC (“K&V Investment One”) (a holder of more than 5% of the Company’s fully diluted capital stock and an entity owned by Mr. Vijay Patel), pursuant to which Parkview agreed to extend a $50 million revolving credit facility to the Company maturing on April 21, 2031. Borrowings under the facility bear interest at 12% per annum (plus an additional 6% during any event of default), payable monthly in arrears, and are secured by substantially all assets of the Company and its subsidiaries. The Company is obligated to repay principal equal to 75% of net profits from pharmaceutical product sales from the prior quarter if it achieves net profits for two consecutive fiscal quarters. As of the date of this Quarterly Report on Form 10-Q, Parkviewthe Company has notborrowed advancedapproximately any$5.8 fundsmillion under the Loan Agreement tosince the Company.inception of the Parkview Credit Facility.

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 (the “ATM 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. On April 8, 2026, the Company filed a prospectus supplement to the Company’s shelf registration statement on Form S-3 filed with the SEC on November 3, 2025 (File No. 333-291239) relating to the shares of common stock available for sale under the Offering Agreement. The Company began making sales under the Offering Agreement in April 2026, selling an aggregate of 104,000301,545 shares of common stock at a weighted average price of $3.09$2.61 per share for gross proceeds of approximately $321,000$0.8 million since the program’s inception.

Acquisition-related costs, consisting of expenses incurred toin effectconnection with a business combination, including legal, advisory, accounting, and valuation fees, are expensed as incurred.

Other income (expense) consists of interest income on our cash and cash equivalents, interest expense on the issued notes payable to the former Kineta employees, and grant income from our NIH-funded research grant assumed in our October 2024 reverse merger transaction with Kintara Therapeutics, Inc. (“Kintara”, and such merger, the “Kintara Merger”).

Comparisons for the Three Months Ended MarchJune 31,30, 2026, and MarchJune 31,30, 2025

Research and development expenses were $5.2$6.6 million and $4.6$4.9 million for the three months ended MarchJune 31,30, 2026, and 2025, respectively. The increase of $0.7$1.7 million is related to the following.

aan decreaseincrease of approximately $0.8$0.5 million due to ongoing clinical development of IFx-2.0;

Acquisition-related costs. Acquisition relatedAcquisition-related costs were $0.0 million and $0.4$3.1 million for the three months ended MarchJune 31,30, 2026, and 2025, respectively2025 and represent costs incurred in relation to the Kineta Merger.

General and Administrative Expenses. General and administrative expenses were $2.3$2.1 million and $2.1$1.9 million for the three months ended MarchJune 31,30, 2026, and 2025, respectively. The increase of $0.3 million was primarily due to increases in non-cash stock compensation expense and increases in costs associated with being a public company.

Grant Income. Grant income was $0.3 million for the three months ended MarchJune 31,30, 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 less than $0.1$0.5 million for the three months ended MarchJune 31,30, 2026 duerelated primarily to interest on the issuedParkview notescredit payable to former Kineta employees.facility.

Interest Income. Interest income was less than $0.1 million and $0.1 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, related primarily to interest income earned on deposits at various banks.

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 $22.6 million for the years ended December 31, 2025, and 2024, respectively, and incurred net losses of $7.5$16.7 million and $6.7$16.2 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. Additionally, we used $27.6 million and $14.7 million of cash from our operating activities for the years ended December 31, 2025,2025 and 2024, respectively, and used $4.4$13.0 million and $4.7$11.0 million from our operating activities for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $148.7$157.9 million.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $6.3$1.0 million. In April 2026, we received $0.3 million in gross proceeds under the ATM Program. Additionally, we have not received any proceeds to date on the Parkview credit facility. We invest our cash and cash equivalents in liquid money market accounts.

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 to 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 $29.2$34.8 million in aggregate principal amount through the issuance of common stockstock, bridge financings, and bridgethe financings.Parkview Credit Facility.

On April 21, 2026, the Company entered into the Loan Agreement with Parkview, pursuant to which Parkview agreed to extend a $50 million revolving credit facility to the Company maturing on April 21, 2031. Borrowings under the facility bear interest at 12% per annum (plus an additional 6% during any event of default), payable monthly in arrears, and are secured by substantially all assets of the Company and its subsidiaries. The Company is obligated to repay principal equal to 75% of net profits from pharmaceutical product sales from the prior quarter if it achieves net profits for two consecutive fiscal quarters. As of this Quarterly Report on Form 10-Q, the Company has borrowed approximately $5.8 million from Parkview under the Loan Agreement.

On November 3, 2025, the Company and Wainwright entered into 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 Quarterly Report,Report on Form 10-Q, we have sold 104,000approximately 301,545 shares of common stock through the program.

On December 9, 2025, we entered into a securities purchase agreement (the “RD Purchase Agreement”) with certain investors (collectively, the “RD Purchasers”).investors. The RD Purchase Agreement relates to the sale and issuance in a registered direct offering (such sale and issuance, the “Registered Direct 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. The Registered Direct Offering resulted in gross proceeds to the Company of approximately $15.6 million, before deducting the placement agents’ fees and other offering expenses payable by the Company.

On June 2, 2025, the Company and the certain accredited investors (the “Purchasers”) entered into a securities purchase agreement pursuant to which we 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 “Offering Warrants”), for an aggregate offering amount of $12.6 million (the “Private Placement”). The combined effective offering price for each share and accompanying Offering Warrant in the offering was $2.65.

The following table sets forth a summary of the net cash flow activity for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively:

For the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities was $4.4$13.0 million, which primarily consisted of a net loss of $7.5$16.8 million,million and a change in net operating assets and liabilities of $0.3$1.6 million, and by non-cash charges of $2.8$5.3 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, and stock-based compensation of $2.8$4.9 million.million, Theamortization of debt issuance costs of $0.3 million netassociated with the revolving credit facility. The $1.6 million change in net operating assets and liabilities is primarilywas due to increasesa decrease in accounts payable and accrued expenses of approximately $0.5$1.7 million due to timing of invoices and vendor payments, and an increase in accrued interest of $0.2 million, and a decrease in current and non-current assets of approximately $0.2$0.1 million.

For the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities was $4.7$11.0 million, which primarily consisted of a net loss of $6.7$16.2 million, a change in net operating assets and liabilities of $0.5$2.3 million, and by non-cash charges of $1.4$2.9 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, and stock-based compensation of $1.4$2.8 million. The $0.5$2.3 million net change in operating assets and liabilities is primarily due to increases in accounts payable and accrued expenses of approximately $0.5$2.3 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately less than $0.1 million.

For the threesix months ended MarchJune 31,30, 2026 and 2025,2026, net cash used in investing activities was less than $0.1 million and $1.2$0.2 million, which consisted of purchases of property and equipment and deposits and payments in connection with the Kineta acquisition.equipment.

For the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities was $7.1$10.6 million, which consisted of $7.0$3.6 million and $0.5 million in proceeds from the issuancescredit revolver, $7.8 million in gross proceeds from the issuance of common stock of which $0.5 million was attributable to the Private Placement, $7.0 million was attributable to the Registered Direct OfferingOffering, and Private$0.3 Placement,million respectively,was receivedattributable into the firstATM quarter of 2026,Program, offset by $0.4 million in payments for the placement agent fees and offering costs related to the various financings, and $0.2 million in payments for deferred offering costs attributable to the Registeredcredit Directfacility Offeringdebt andissuance Private Placement, and $0.2 million principal payment of note payables to former Kineta employees.costs.

For the threesix months ended MarchJune 31,30, 2025, net cash usedprovided inby financing activities was $0.6$8.1 million, which consisted $0.5of $3.6 million proceeds from warrantswarrant exercises, $5.9 million in gross proceeds from the issuance of common stock attributable to the Private Placement, offset by $0.3 million in payments for deferred offering costs attributable to the Private Placement and $1.1 million in merger transaction costs and net liabilities attributable to Kintara..Kintara.

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 threesix months ended MarchJune 31,30, 2026, contained in Part I, Item 1 in this Quarterly Report on Form 10-Q, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.

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 recognizesrecognize 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.

Goodwill and other intangible assets comprised of IPR&D on our balance sheet as of MarchJune 31,30, 2026 and December 31, 2025 were in connection with the Kineta Merger.

There are no recently issued and adopted accounting pronouncements that have a material effect on the CompanyCompany’s financial statements.