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 ...

[Form 8-K: Current Report](index=1&type=section&id=Form%208-K) This Form 8-K details company and filing information, recent financial results, a proposed merger, cautionary statements, and relevant exhibits [Company and Filing Details](index=1&type=section&id=Company%20and%20Filing%20Details) This Form 8-K was filed by TuHURA Biosciences, Inc. on May 15, 2025, with its common stock registered on The Nasdaq Capital Market under the symbol HURA - Filing entity: **TuHURA BIOSCIENCES, INC.**, a Nevada corporation[2](index=2&type=chunk) - Report date: **May 15, 2025**[2](index=2&type=chunk) 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 | [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) On May 15, 2025, TuHURA Biosciences issued a press release (Exhibit 99.1) announcing its financial results for the three months ended March 31, 2025, and providing a corporate update, with the information considered furnished, not filed - A press release was issued on **May 15, 2025**, detailing financial results for the quarter ended **March 31, 2025**[7](index=7&type=chunk) - Exhibit 99.1, the press release, includes a corporate update[7](index=7&type=chunk) - Information in this report and exhibit is furnished, not filed, under the Securities Exchange Act of 1934, unless explicitly referenced in future filings[7](index=7&type=chunk) [Proposed Merger with Kineta, Inc.](index=3&type=section&id=Proposed%20Merger%20with%20Kineta%2C%20Inc.) This section details the proposed merger with Kineta, Inc., referencing the Form S-4 registration statement filed with the SEC, clarifying that this 8-K is not a solicitation and identifying participants [Important Additional Information](index=3&type=section&id=Important%20Additional%20Information) TuHURA filed a Form S-4 registration statement on February 7, 2025, containing a preliminary joint proxy statement and prospectus regarding the proposed merger with Kineta, which will be available on the SEC and TuHURA websites - TuHURA filed a Form S-4 registration statement with the SEC on **February 7, 2025**, regarding the proposed merger with Kineta, Inc[8](index=8&type=chunk) - Investors are urged to review the Joint Proxy Statement/Prospectus for critical merger information[8](index=8&type=chunk) - Finalized documents will be mailed to stockholders and accessible on the SEC's website (www.sec.gov) and TuHURA's website (www.tuhurabio.com)[9](index=9&type=chunk) [No Offer or Solicitation](index=3&type=section&id=No%20Offer%20or%20Solicitation) This Form 8-K is explicitly not a proxy statement, an offer to sell, or a solicitation of an offer to buy any securities in relation to the merger, with any securities offering to be conducted via a prospectus - This Form 8-K is not a proxy statement or a solicitation for the merger[10](index=10&type=chunk) - It does not constitute an offer to sell or a solicitation to buy securities of TuHURA or Kineta[10](index=10&type=chunk) [Participants in the Solicitation](index=3&type=section&id=Participants%20in%20the%20Solicitation) The directors and executive officers of both TuHURA and Kineta may be considered participants in the solicitation of proxies for the merger, with details regarding their interests disclosed in SEC filings and the Joint Proxy Statement/Prospectus - Directors and officers of TuHURA and Kineta may be considered participants in the merger's proxy solicitation[11](index=11&type=chunk) - Information on TuHURA's directors and officers is available in its Form 10-K filed on **March 31, 2025**[11](index=11&type=chunk) - Further details on participant interests will be provided in the Joint Proxy Statement/Prospectus[11](index=11&type=chunk)[12](index=12&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) This report contains forward-looking statements concerning TuHURA's product candidates, development programs, the proposed merger with Kineta, and capital requirements, which are based on current expectations and not guarantees of future performance, with no obligation to update them - Forward-looking statements cover TuHURA's **IFx-Hu2.0** product candidate, tumor microenvironment modulators program, and the potential acquisition of Kineta Inc[13](index=13&type=chunk) - Statements also address capital resources, additional capital needs (including for the Kineta merger), and regulatory pathways[13](index=13&type=chunk) - The company disclaims any obligation to publicly update or revise forward-looking statements unless legally mandated[14](index=14&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=4&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits filed with the Form 8-K, primarily the press release from May 15, 2025, containing financial results and a corporate update Exhibits | Exhibit No. | Document Description | | :--- | :--- | | 99.1 | Press Release, dated May 15, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=7&type=section&id=Signatures) The report was officially signed on May 15, 2025, by Dan Dearborn, the Chief Financial Officer of TuHURA Biosciences, Inc - The report is signed by **Dan Dearborn**, Chief Financial Officer[21](index=21&type=chunk) - Signature date: **May 15, 2025**[21](index=21&type=chunk)

Core Insights - TuHURA Biosciences is advancing its clinical programs, including the initiation of a Phase 3 trial for IFx-Hu2.0 in combination with Keytruda for advanced Merkel cell carcinoma (MCC) [1][3] - The company is targeting the acquisition of Kineta, Inc. and plans to initiate a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated acute myeloid leukemia (AML) [2][3] Clinical Development - TuHURA has initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in patients with Merkel cell carcinoma of unknown primary origin (MCCUP) [1][4] - The Phase 3 trial for IFx-Hu2.0 is expected to begin in Q2 2025, pending the lifting of a partial clinical hold by the FDA [3][10] - The Phase 1b/2a trial will include patients with deep-seated tumors who are not eligible for the Phase 3 trial, addressing a significant patient population [3][4] Financial Overview - For the first quarter ended March 31, 2025, research and development expenses were $4.6 million, compared to $3.6 million for the same period in 2024 [6] - General and administrative expenses increased to $2.4 million in Q1 2025 from $1.0 million in Q1 2024 [6] Corporate Updates - TuHURA is in the process of acquiring Kineta, Inc., with the deal expected to close in Q2 2025, subject to financing and other conditions [2][8] - The company appointed Dr. Bertrand Le Bourdonnec as Head of Drug Discovery and Dr. Craig L. Tendler to its Board of Directors, enhancing its leadership team [10] Upcoming Milestones - Q2 2025: Anticipated initiation of the Phase 3 trial for IFx-Hu2.0 and closing of the Kineta acquisition [10] - Q3 2025: Planned initiation of a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated AML [10]

TAMPA, Fla., May 13, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that James A. Bianco, M.D., President and Chief Executive Officer of TuHURA, will present a company overview, including highlights of its IFx-Hu2.0 Phase 3 program, and its first-in-class bi-specific immune modulating Antibody drug, or peptide conjugates (ADCs, APCs) targeting Myeloid Deriv ...

Core Viewpoint - TuHURA Biosciences has initiated a Phase 1b/2a trial for IFx-Hu2.0 in combination with Keytruda® to evaluate safety and feasibility in patients with deep-seated tumors, expanding the potential patient population for this treatment [1][2][4]. Group 1: Trial Details - The Phase 1b/2a trial is designed to assess the safety and feasibility of IFx-Hu2.0 as an adjunctive therapy to Keytruda® in adult patients with non-cutaneous Merkel cell carcinoma (MCC) [4]. - The trial will enroll a total of nine patients with hepatic, pulmonary, or retroperitoneal lesions, administering IFx-Hu2.0 (0.1 mg) weekly for three weeks, followed by pembrolizumab [4]. - The primary endpoint is the safety and feasibility of IFx-Hu2.0 evaluated 28 days after the last dose, with secondary endpoints including efficacy assessed at three and six months [4]. Group 2: Future Plans - If the trial demonstrates safety and feasibility, TuHURA plans to extend enrollment to other non-MCC cancers that poorly respond to checkpoint inhibitors [3]. - The company is preparing to initiate a Phase 3 accelerated approval trial of IFx-Hu2.0 as an adjunctive therapy to Keytruda® for first-line treatment of advanced or metastatic MCC [5][9]. - The FDA has agreed to the trial's design under the accelerated approval pathway, with overall response rate (ORR) as the primary endpoint [6][7]. Group 3: Company Overview - TuHURA Biosciences is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [8]. - The lead product candidate, IFx-Hu2.0, is designed to overcome primary resistance to checkpoint inhibitors, with prior trials showing promise in various skin cancers [9][10].

Core Insights - TuHURA Biosciences, Inc. is advancing its Phase 3 immune-oncology initiatives, focusing on overcoming resistance to cancer immunotherapy [5][6] - The company announced that abstracts from Kineta Inc. and Moffitt Cancer Center will be presented at the AACR Annual Meeting 2025, showcasing novel therapies for advanced melanoma [1][2] Group 1: Company Developments - TuHURA is set to present initial results from a Phase 1 study of KVA12123, an anti-VISTA antibody, in combination with pembrolizumab for advanced solid tumors [2] - The company is preparing to initiate a Phase 3 trial for its lead product, IFx-2.0, as an adjunctive therapy to Keytruda® for advanced Merkel Cell Carcinoma [6] - TuHURA has entered into a merger agreement with Kineta, Inc. to acquire the rights to KVA12123, with the merger expected to close in Q2 2025 [4] Group 2: Research and Presentations - The accepted abstracts for the AACR Annual Meeting include mechanistic insights into IFx-Hu2.0 responses after prior anti-PD-1 therapy failure [2] - Presentations will take place on April 28, 2025, with specific sessions dedicated to experimental therapeutics and immunology [2][3]

Core Insights - TuHURA Biosciences, Inc. has appointed Dr. Bertrand Le Bourdonnec as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management, bringing extensive experience in drug discovery and development [1][3][4] Company Overview - TuHURA is a Phase 3 registration-stage immuno-oncology company focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [6][8] - The company is preparing to initiate a Phase 3 trial for its lead candidate, IFx-2.0, as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [7] Leadership and Expertise - Dr. Le Bourdonnec has a proven track record in leading R&D programs across various therapeutic areas, including oncology and pain management, and is an expert in the biochemistry and pharmacology of the Delta Opioid Receptor (DOR) [2][4] - His previous roles include Chief Scientific Officer at HDAX Therapeutics and VP at Deciphera Pharmaceuticals, where he managed significant teams and contributed to the development of novel therapeutics [4][5] Technology and Innovation - TuHURA is leveraging its DOR technology to develop first-in-class bi-specific Antibody Drug Conjugates (ADCs) and Antibody Peptide Conjugates (APCs) targeting Myeloid Derived Suppressor Cells (MDSCs) to enhance the immune response in the tumor microenvironment [8] - The company aims to address unmet medical needs and transform treatment paradigms for cancer patients through innovative drug development [4][6]

Financial Results - TuHURA Biosciences reported its financial results for the year ended December 31, 2024, with a focus on corporate updates[6]. Merger with Kineta, Inc. - The company is in the process of merging with Kineta, Inc., which involves a registration statement filed with the SEC on February 7, 2025[7]. - The merger is subject to conditions, including the adoption of the Merger Agreement by stockholders of both companies[12]. - TuHURA is expected to realize synergies from the merger, although specific amounts and timing are uncertain[12]. - The estimated net working capital deficit for Kineta at closing should not exceed $12 million[12]. - TuHURA's management anticipates potential risks related to the merger, including market conditions and integration challenges[12]. - The company emphasizes the importance of reading the Joint Proxy Statement/Prospectus for detailed information regarding the merger[8]. - TuHURA's stockholders may experience dilution of ownership percentage post-merger[12]. - The merger could impact TuHURA's business relationships and operational strategies[12]. Availability of Financial Documents - TuHURA's financial statements and additional documents will be available on the SEC and company websites[8].

Financial Performance - For the fiscal year ended June 30, 2024, the company reported a net loss of approximately $8.5 million and an accumulated deficit of approximately $159.9 million[97][99]. - Research and development expenses for the years ended June 30, 2024, and 2023 were approximately $2.7 million and $9.3 million, respectively[91]. - As of June 30, 2024, the company had cash and cash equivalents of approximately $4.9 million, which is expected to fund operations for less than one year[101]. - The company has expressed substantial doubt about its ability to continue as a going concern within one year from the date of filing the consolidated financial statements[96][98]. - The company is not currently in compliance with Nasdaq's minimum bid price requirement and may face delisting if compliance is not regained[105][106]. Clinical Development and Studies - The REM-001 therapy has shown a complete response in approximately 80% of evaluable tumor sites treated in previous studies for cutaneous metastatic breast cancer (CMBC)[12]. - As of October 7, 2024, four patients had been dosed in the open-label 15-patient REM-001 study in CMBC[10]. - The company plans to complete enrollment of patients in the REM-001 Study in the fourth calendar quarter of 2024[13]. - REM-001 has been safely administered to over 1,100 patients in prior clinical studies, with an approvable letter from the FDA for an aspect of AMD in 2004[19]. - The Phase 2/3 studies of REM-001 for CMBC indicated higher tumor response rates compared to alternative treatments[29]. - The average rate of clinical success in study CA013 was 88%, while study CA019 reported an 83% success rate[39]. - Positive results from previous clinical studies of REM-001 may not predict future outcomes, potentially resulting in development delays or failure to obtain marketing approval[151]. - Clinical studies are inherently uncertain, and unfavorable results could delay or prevent marketing approval[143][147]. Regulatory and Compliance - The company has received Fast Track Designation from the FDA for REM-001 in CMBC[14]. - The FDA granted orphan drug designation for tin ethyl etiopurpurin, the active ingredient in REM-001, for treatment of basal cell carcinoma nevus syndrome[54]. - The approval process for new products involves rigorous preclinical and clinical testing, with an average NDA review process taking 10 months[62][63]. - The FDA offers various expedited approval mechanisms for drug candidates, including accelerated approval and breakthrough drug designation, which may apply to the company's current candidates[65]. - Regulatory approval timelines vary, with the FDA review process potentially taking over 12 months even for products designated as fast track[169]. Market Opportunity and Competition - The estimated market opportunity for the treatment of cutaneous metastatic breast carcinoma (CMBC) is approximately $500 million[23]. - The oncology market is characterized by a large unmet medical need, making it highly competitive with numerous existing therapies and ongoing developments[78]. - The company faces significant competition in the oncology market from major pharmaceutical and biotechnology companies, which may impact the commercialization of its product candidates[78]. - Many competitors have greater financial resources and expertise, which could hinder the company's ability to compete effectively in drug development and marketing[84]. Strategic Initiatives - A merger agreement was entered into with TuHURA, with existing stockholders expected to own approximately 2.85% of the post-merger company on a fully-diluted basis[10]. - The proposed merger with TuHURA is expected to be consummated in mid-October 2024, subject to regulatory approval[10]. - The company initiated a process to explore strategic alternatives focused on maximizing stockholder value in December 2023[9]. Product Liability and Risks - The company faces inherent risks of product liability claims due to clinical testing of product candidates, which could lead to substantial liabilities and limit commercialization efforts[191]. - The company may incur significant costs related to product liability litigation, which could adversely affect its financial condition and operational results[192]. - The company may face litigation risks related to patent infringements, which could distract management and incur substantial costs[132][133]. Intellectual Property and Proprietary Rights - The company relies on patent protection and trade secrets to maintain its proprietary position for REM-001 and its related technologies[49]. - The company does not hold any patents covering its laser light source or light delivery device for REM-001, which may allow competitors to offer similar products[127]. - The company is dependent on obtaining certain patents and protecting its proprietary rights, which are crucial for its competitive advantage[118]. Operational Structure - The company operates with a "virtual" corporate structure, having only one full-time employee and approximately 10 independent contractors[92]. - The company is currently focused on the development of one product candidate, REM-001 for CMBC, with enrollment for a 15-patient clinical study expected to complete in Q4 2024[111]. Third-Party Relationships - The company expects to continue relying on third-party clinical research organizations (CROs) for clinical studies, and any failure by these parties to meet obligations could delay market introduction of product candidates[195]. - The company relies on third parties, including academic institutions and private oncology centers, for conducting clinical studies, which may jeopardize the validity of clinical data and delay regulatory approvals[193].