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]

Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $22.6 million, compared to a net loss of $29.3 million for the year ended December 31, 2023[81]. - The company incurred a net loss of $6.7 million for the three months ended March 31, 2025, compared to a net loss of $4.8 million for the same period in 2024, reflecting an increase in losses of $1.8 million[108]. - The company has incurred significant operating losses and anticipates these losses will increase as it advances product candidates through development[81]. - Total operating expenses for the three months ended March 31, 2025, were $7.0 million, an increase of $2.4 million from $4.6 million in 2024[108]. Cash Position - As of March 31, 2025, the company had an accumulated deficit of $117.8 million and cash and cash equivalents of $6.2 million[84]. - As of March 31, 2025, the company had cash and cash equivalents of $6.2 million, with investments in liquid money market accounts[119]. - The company used $4.7 million in cash from operating activities for the three months ended March 31, 2025, compared to $3.8 million used in the same period in 2024[117]. - For the three months ended March 31, 2025, net cash used in operating activities was $4.7 million, consisting of a net loss of $6.7 million and non-cash charges of $1.4 million[130]. - The company expects existing cash and cash equivalents to meet anticipated cash requirements through late Q4 2025, excluding cash needed for the Kineta Merger[134]. Research and Development - The company has not generated any revenue from product sales and does not expect to do so in the near future[99]. - The company is preparing to initiate a Phase 3 trial of its lead product candidate, IFx2.0, as an adjunctive therapy to Keytruda® for patients with advanced Merkel Cell Carcinoma[79]. - The company has initiated a Phase 1b/2a study of IFx-Hu2.0 in combination with Keytruda® for metastatic Merkel cell carcinoma[97]. - Research and development expenses increased to $4.6 million for the three months ended March 31, 2025, up from $3.6 million in the same period in 2024, representing a $1.0 million increase[111]. - The company anticipates continued increases in research and development and general administrative expenses to support ongoing activities and potential commercialization efforts[106]. Mergers and Acquisitions - The company completed a merger with Kintara Therapeutics on October 18, 2024, which included a 1-for-35 reverse stock split[85]. - The company anticipates needing at least $20 million in gross proceeds from a financing transaction to close the Kineta Merger[135]. - The company entered into a Clinical Trial Funding Agreement with Kineta, agreeing to fund clinical trial expenses for KVA12123 up to $900,000[95]. - The company raised approximately $41.6 million in net proceeds through preferred stock financings since inception, which were converted into shares of Kintara common stock as part of the Kintara Merger[121]. Expenses - General and administrative expenses rose to $2.4 million for the three months ended March 31, 2025, compared to $1.0 million in 2024, an increase of $1.4 million primarily due to non-cash stock compensation and merger transaction costs[112]. - The company expects to incur additional costs associated with operating as a public company, including legal, accounting, and compliance expenses[82]. - Stock-based compensation expense for the three months ended March 31, 2025, included $1.4 million related to stock-based compensation[130]. Financing Activities - For the three months ended March 31, 2025, net cash used in financing activities was $0.6 million, including $0.5 million from warrant exercises and $1.1 million in merger transaction costs[133]. - The TuHURA Notes financing raised an aggregate principal amount of $31.3 million, with a maturity date of December 1, 2025, and an interest rate of 20% per annum[122]. - The company may finance cash needs through public or private equity offerings, debt financings, or collaborations, which could dilute stockholder ownership[137]. Other Information - The company does not have any off-balance sheet arrangements as defined under SEC rules[149]. - The company has paid approximately $852,000 in clinical trial expenses under the Clinical Trial Funding Agreement and $250,000 in working capital loans[95]. - Grant income was $0.3 million for the three months ended March 31, 2025, related to the Kintara Health and Human Services grant[113]. - The company has not experienced material differences between estimated and actual accrued research and development expenses[142].

[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]

Core Insights - TuHURA Biosciences, Inc. is focused on developing novel technologies to address resistance to cancer immunotherapy, with a particular emphasis on its Phase 3 programs and innovative antibody drug conjugates [4][5][6] Group 1: Company Overview - TuHURA is a Phase 3 immune-oncology company that aims to overcome both primary and acquired resistance to cancer immunotherapy, which are common reasons for treatment failure [4] - The company is preparing to initiate a randomized placebo-controlled Phase 3 trial of its lead product, IFx-2.0, in combination with Keytruda® for advanced Merkel Cell Carcinoma [5] - TuHURA's acquisition of Kineta, Inc. is expected to enhance its portfolio, including the rights to Kineta's KVA12123 antibody, with the merger targeted to close in Q2 2025 [3] Group 2: Upcoming Events - James A. Bianco, M.D., CEO of TuHURA, will present at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025, highlighting the company's Phase 3 program and its bi-specific immune modulating antibody drug [1][2] - Management will also be available for one-on-one meetings with qualified investors during the conference [2] Group 3: Research and Development - TuHURA is leveraging its Delta Opioid Receptor technology to develop bi-specific immune modulating antibody drug conjugates targeting Myeloid Derived Suppressor Cells, aiming to prevent T cell exhaustion [7] - The company plans to initiate a randomized trial in Q3 2025 for a menin inhibitor combined with a VISTA inhibiting antibody in relapsed or refractory Acute Myeloid Leukemia (AML) [6]

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].