[FORM 8-K Filing Details](index=1&type=section&id=FORM%208-K%20Filing%20Details) This section outlines the administrative and securities information pertinent to the Form 8-K filing [Registrant and Filing Information](index=1&type=section&id=Registrant%20and%20Filing%20Information) This section provides administrative details of the Form 8-K filing, including registrant identity and event date - The registrant is TUHURA BIOSCIENCES, INC., incorporated in Nevada, with its principal executive offices in Tampa, Florida[2](index=2&type=chunk) - The date of the earliest event reported in this filing is August 14, 2025[2](index=2&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) This section details the registrant's registered securities and its status concerning emerging growth company provisions Registered Securities | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.001 par value per share | HURA | The Nasdaq Capital Market | - The registrant has indicated that it is not an emerging growth company[6](index=6&type=chunk) [Current Report Items](index=3&type=section&id=Current%20Report%20Items) This section details the specific items reported in the Form 8-K, including financial results and accompanying exhibits [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This item reports TuHURA Biosciences, Inc. issued a press release detailing financial results for Q2 2025 and a corporate update - On August 14, 2025, TuHURA Biosciences, Inc. issued a press release reporting financial results for the three months ended June 30, 2025, and providing a corporate update[7](index=7&type=chunk) - The press release (Exhibit 99.1) is attached to this Current Report and incorporated by reference, but the information is furnished and not deemed 'filed' for most purposes[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This item lists the exhibits accompanying the Form 8-K filing, which include the press release with financial results and the interactive data file List of Exhibits | Exhibit No. | Document | | :------------ | :---------------------------------------------------- | | 99.1 | Press Release, dated August 14, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | [SIGNATURES](index=4&type=section&id=SIGNATURES) This section provides the formal signatures, confirming the authorization and submission of the report [Report Signatures](index=4&type=section&id=Report%20Signatures) This section formally concludes the Form 8-K filing with the required signatures, confirming the registrant's authorization - The report was signed on August 14, 2025, by Dan Dearborn, Chief Financial Officer of TUHURA BIOSCIENCES, INC.[13](index=13&type=chunk)

Core Insights - TuHURA Biosciences has completed the acquisition of Kineta, Inc. and its VISTA inhibiting monoclonal antibody, now named TBS-2025, with plans to initiate a Phase 2 trial in relapsed/refractory NPM1-mutated Acute Myeloid Leukemia (AML) in the second half of 2025 [1][4] - The company has initiated a Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced and metastatic Merkel cell carcinoma (MCC), under a Special Protocol Assessment (SPA) agreement with the FDA [1][3] Corporate Highlights - TuHURA completed a $12.5 million equity financing transaction and received an additional $3 million from warrant exercise proceeds [2][5] - The company was included in the Russell 3000® and Russell 2000® Indexes as of June 27, 2025 [4] Clinical Development - The Phase 3 trial of IFx-2.0 is a single randomized placebo-controlled trial that could potentially meet the requirements for both accelerated and full approval without the need for a post-accelerated approval confirmatory trial [3] - A Phase 1b/2a trial has been initiated for IFx-2.0 as an adjunctive therapy in first-line treatment of checkpoint-naïve patients with MCC of unknown primary origin, targeting newly diagnosed patients with metastatic tumors [3] Financial Performance - Research and development expenses for the second quarter of 2025 were $4.9 million, compared to $2.8 million for the same period in 2024 [7] - Net cash outflows from operating activities for the first half of 2025 were ($10.9) million, compared to ($8.9) million for the same period in 2024 [7] Upcoming Milestones - The company plans to advance TBS-2025 into a randomized Phase 2 trial in the second half of 2025 [6] - TuHURA anticipates providing updates on enrollment progress in its Phase 3 trial of IFx-2.0 by the end of 2025 and topline results from the Phase 1b/2a trial in Q1 2026 [12]

Core Points - TuHURA Biosciences, Inc. has been added to the Russell 3000® Index and automatically included in the Russell 2000® Index as part of the 2025 annual reconstitution, effective June 27, 2025 [1][2] - The inclusion in the Russell indexes signifies the company's progress in its first year as a publicly traded entity and reflects its potential for continued development [2] - TuHURA is currently enrolling patients in a Phase 3 accelerated approval trial of its lead product IFx-2.0, which is being tested as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel cell carcinoma [2][11] - The company has also acquired a novel anti-VISTA antibody from Kineta, Inc. and plans to advance it into a Phase 2 clinical trial for treating NMPL1-mutated Acute Myeloid Leukemia [2] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing both primary and acquired resistance [10] - The company's lead product, IFx-2.0, is designed to enhance the effectiveness of checkpoint inhibitors [11] - TuHURA is also leveraging its Delta Opioid Receptor technology to create bi-specific antibody drug conjugates aimed at inhibiting immune suppression in the tumor microenvironment [12]

Acquisition Overview - TuHURA Biosciences has successfully completed the acquisition of Kineta, Inc., which includes a novel VISTA inhibiting monoclonal antibody (mAb) now named TBS-2025, enhancing TuHURA's late-stage immuno-oncology pipeline [1][2] - The acquisition allows TuHURA to initiate a Phase 2 randomized trial for TBS-2025 in the second half of 2025 [1] Financial Details - The completion of the acquisition unlocks the fourth tranche of funds from a $12.5 million aggregate PIPE financing announced on June 3, 2025 [1] - Each share of Kineta common stock was converted into the right to receive 0.185298 shares of TuHURA common stock, totaling 2,868,169 shares [3] Product Development - TBS-2025 is positioned to overcome acquired resistance to cancer immunotherapy, particularly in patients with NPM1 mutated acute myeloid leukemia (AML) [2] - The drug is being investigated in combination with a menin inhibitor, aiming to improve response rates and reduce relapse in AML patients [2] Mechanism of Action - VISTA is a significant immune checkpoint expressed on myeloid cells, contributing to immunosuppression in the tumor microenvironment [5] - TBS-2025 is designed to block VISTA, potentially enhancing T cell function and improving treatment outcomes in cancer therapy [5][6] Clinical Trials - TBS-2025 has shown promising results in a Phase 1/2 trial, demonstrating good tolerance and over 90% receptor occupancy [7] - The drug is administered intravenously every two weeks and has been tested both as a monotherapy and in combination with pembrolizumab [6][7] Company Background - TuHURA Biosciences focuses on developing technologies to address primary and acquired resistance to cancer immunotherapy [8] - The company is also working on bi-specific antibody drug conjugates targeting myeloid derived suppressor cells to enhance immune response [10]

Core Viewpoint - TuHURA Biosciences and Kineta have successfully completed stockholder meetings, approving a merger and key proposals, including an increase in authorized shares and reincorporation in Delaware [1][2]. Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing technologies to overcome resistance to cancer immunotherapy [4]. - Kineta, Inc. is a clinical-stage biotechnology company dedicated to creating next-generation immunotherapies to address challenges in current cancer treatments [8]. Merger Details - TuHURA stockholders approved all proposals at the TuHURA Special Meeting, including increasing authorized shares to 200 million [1]. - Kineta stockholders also approved the merger with TuHURA at their Special Meeting [2]. - The merger is expected to close soon after satisfying remaining conditions [2]. Product Development - TuHURA's lead product, IFx-2.0, aims to overcome primary resistance to checkpoint inhibitors and is preparing for a Phase 3 trial in advanced Merkel Cell Carcinoma [5]. - TuHURA is also developing bi-specific antibody drug conjugates targeting Myeloid Derived Suppressor Cells to enhance immune response [6]. - Kineta's pipeline includes KVA12123, a VISTA blocking immunotherapy in Phase 1/2 trials, showing strong tumor growth inhibition in preclinical models [9]. Financial and Strategic Context - Kineta underwent a corporate restructuring in February 2024 to reduce expenses and preserve cash, including workforce reductions and halting new patient enrollment in trials [10]. - The merger aims to maximize stockholder value and enhance the combined company's capabilities in immunotherapy [10].

Group 1 - Halper Sadeh LLC is investigating TuHURA Biosciences, Inc. (NASDAQ: HURA) for potential violations related to its merger with Kineta, Inc. [1] - Vigil Neuroscience, Inc. (NASDAQ: VIGL) is under scrutiny due to its sale to Sanofi, where shareholders will receive $8.00 per share in cash and a contingent value right for an additional $2.00 per share based on the commercial sale of VG-3927 [1] - The firm may seek increased consideration for shareholders and additional disclosures regarding the proposed transactions [2] Group 2 - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options at no cost [3] - The firm represents investors globally who have experienced securities fraud and corporate misconduct, recovering millions for defrauded investors [3]

Core Viewpoint - TuHURA Biosciences, Inc. is set to initiate its Phase 3 accelerated approval trial for IFx-2.0 in combination with Keytruda® for advanced and metastatic Merkel cell carcinoma, following the removal of a partial clinical hold by the FDA [1][3] Group 1: Trial Details - The Phase 3 trial will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks alongside Keytruda®, compared to Keytruda® plus placebo [3] - The trial is expected to enroll 118 participants across approximately 22 to 25 U.S. sites, with a randomization ratio of 1:1 [3] - The primary endpoint is Overall Response Rate (ORR), with a key secondary endpoint of Progression Free Survival (PFS) [3] Group 2: Financial Aspects - The resolution of the partial clinical hold allows the company to unlock the second tranche of funding from a $12.5 million PIPE financing, triggering an additional payment of $2.23 million [1][3] - The company had previously announced this financing on June 3, 2025 [1] Group 3: Company Overview - TuHURA Biosciences focuses on developing novel technologies to overcome resistance to cancer immunotherapy, addressing primary and acquired resistance [4][5] - The lead product candidate, IFx-2.0, is designed to enhance the efficacy of checkpoint inhibitors [5]

Core Viewpoint - TuHURA Biosciences, Inc. has secured $12.5 million in a private offering to fund its operations, including a proposed merger with Kineta, Inc. and the initiation of a Phase 3 trial for its lead product, IFx-2.0 [1][5][9] Funding Details - The private placement involves the issuance of 4.6 million shares of common stock at a price of $2.65 per share, representing a 15% discount to the closing price on June 2, 2025 [1] - Approximately $9.0 million of the total offering will be purchased in four equal tranches based on the achievement of specific milestones, with the remaining $3.5 million to be funded by December 31, 2025 [2][7] - The initial closing of the offering is anticipated on June 4, 2025, subject to customary closing conditions [2] Use of Proceeds - The net proceeds from the offering will be used to fund the merger with Kineta, initiate the Phase 3 trial for IFx-2.0, advance Kineta's VISTA-inhibiting antibody to a Phase 2 trial, and cover other working capital needs [5][9] Milestones for Funding - The funding milestones include: - Notification from the FDA that the company is no longer under a partial clinical hold for the Phase 3 trial of IFx-2.0 [7] - Initiation of the Phase 3 trial for IFx-Hu2.0 [7] - Completion of the merger with Kineta [7] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, particularly through its lead product, IFx-2.0, which is designed to enhance the efficacy of existing treatments [11][12] - The company is also advancing a bi-specific antibody drug conjugate and antibody peptide conjugate targeting immune-suppressing cells in the tumor microenvironment [14]

Core Insights - TuHURA Biosciences is advancing its Phase 3 trial of IFx-Hu2.0 as an adjunctive therapy with Keytruda® for patients with advanced or metastatic Merkel cell carcinoma (MCC) [1][2][4] - The trial is designed under the FDA's Accelerated Approval Pathway and Special Protocol Assessment (SPA) agreement, aiming to address primary resistance to checkpoint inhibitors [1][3][4] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, particularly in the context of MCC [5][6] - The company’s lead product, IFx-Hu2.0, is an innate immune agonist intended to activate the immune response in patients who do not respond to existing checkpoint inhibitor therapies [3][6] Trial Design and Objectives - The Phase 3 trial will evaluate IFx-Hu2.0 (0.1 mg) administered weekly for three weeks alongside pembrolizumab (200 mg) every three weeks, compared to pembrolizumab plus placebo [4] - The trial aims to enroll 118 CPI-naïve patients across approximately 22 to 25 U.S. sites, with primary endpoints focusing on overall response rate (ORR) and secondary endpoints including progression-free survival (PFS) and safety [4] Clinical Background - Merkel cell carcinoma is characterized as a rare and aggressive tumor type, with poor survival rates for patients who do not respond to first-line checkpoint inhibitor therapy [3] - Previous Phase 1b trials indicated that IFx-Hu2.0 could achieve an overall response rate of 63% in patients who progressed on pembrolizumab or avelumab, with response durations ranging from 6 to 33 months [3]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39473 TUHURA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 99-0360497 ( State or other jurisdiction of incorporation or organization) 10500 University Center Dr., Suite 110 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...