For the fiscal year ended December 31, 2025 or UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (Exact name of registrant as specified in its charter) Nevada 99-0360497 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 10500 University Center Dr., Suite 110 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exc ...

Core Insights - TuHURA Biosciences has appointed Dr. Craig L. Tendler as the leader of its VISTA Program in AML and other blood-related cancers, while he continues his role on the Board of Directors [1][2] - Dr. Tendler brings over 29 years of experience in drug development, having coordinated over 30 oncology regulatory approvals and 15 new medical entity approvals, contributing to more than $16 billion in global sales from multiple myeloma treatments [1][2] - The company is focused on developing TBS-2025, a VISTA inhibiting antibody, which is expected to address immunosuppressive roles in AML, particularly in NPM1 mutated cases [2][6] Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company that develops novel therapeutics aimed at overcoming resistance to cancer immunotherapy [4] - The company’s lead product, IFx-2.0, is designed to counter primary resistance to checkpoint inhibitors and is currently undergoing a Phase 3 trial in combination with Keytruda® for advanced Merkel Cell Carcinoma [5] - TuHURA acquired TBS-2025 through a merger with Kineta Inc. and is advancing it into Phase 2 development for mutNPM1 r/r AML [6] Leadership and Experience - Dr. Tendler previously served as Vice President of Oncology Clinical Development at Johnson & Johnson, where he was instrumental in securing global approvals for several oncology treatments [2][3] - His experience includes leading clinical diligence teams for significant acquisitions and co-development agreements in the oncology sector [2][3] - Dr. Tendler has also held academic positions and has been involved in various cancer research initiatives, enhancing his expertise in the field [3]

Core Viewpoint - TuHURA Biosciences is actively participating in upcoming investor conferences to showcase its advancements in immuno-oncology and discuss its novel therapeutics aimed at overcoming resistance to cancer immunotherapy [1] Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing innovative therapies to address primary and acquired resistance to cancer immunotherapy, which are significant challenges in effective cancer treatment [1] - The company's lead product, IFx-2.0, is designed to counteract primary resistance to checkpoint inhibitors and is currently undergoing a Phase 3 registration trial as an adjunctive therapy to Keytruda® (pembrolizumab) for advanced or metastatic Merkel Cell Carcinoma [1] Upcoming Events - Dr. James Bianco, President and CEO of TuHURA, will participate in the Citizens Life Science Conference on March 10, 2026, at 4:00 pm ET, with a live and archived webcast available [1] - TuHURA will also be present at the Leerink Global Healthcare Conference on March 11, 2026, where one-on-one meetings with investors can be arranged [1] Product Development - TuHURA has acquired TBS-2025 through its merger with Kineta Inc. on June 30, 2025, which is a VISTA inhibiting monoclonal antibody entering Phase 2 development for mutNPM1 r/r AML [1] - The company is also utilizing its Delta Opioid Receptor technology to create first-in-class bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells, aiming to mitigate their immune-suppressing effects on the tumor microenvironment [1]

Core Insights - TuHURA Biosciences has filed an Investigational New Drug Application (IND) for TBS-2025, a novel VISTA inhibiting antibody, aimed at treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia (AML) in combination with a menin inhibitor [1] - The company plans to initiate a Phase 2 study in early Q2 2026, targeting menin inhibitor naïve patients, with preliminary results expected in Q3 2026 [1] - TBS-2025 is expected to address the unmet medical need in AML treatment, as current therapies have low complete response rates of less than 25% [1] Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to overcome resistance to cancer immunotherapy [1] - The company’s lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 trial for advanced Merkel Cell Carcinoma [1] - TBS-2025 was acquired through the merger with Kineta Inc. and is moving into Phase 2 development for mutNPM1 r/r AML [1] Scientific Rationale - Scientific evidence indicates that mutations like mutNPM1 drive VISTA expression on leukemic cells, contributing to poor therapy responses and high relapse rates in AML [1] - The removal of the VSIR gene, which encodes for VISTA, in murine models has shown enhanced immune response and improved survival rates [1] - TBS-2025 demonstrated a favorable safety profile in a Phase 1 trial, with an optimal Phase 2 dose anticipated to be 750mg every three weeks [1]

Core Insights - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to address resistance to cancer immunotherapy [1] - The company will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, at 3:20 pm ET [1] Company Overview - TuHURA is developing technologies to overcome primary and acquired resistance to cancer immunotherapy, which are common reasons for the failure of these treatments [1] - The lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 registration trial as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [1] Recent Developments - TuHURA acquired TBS-2025 through its merger with Kineta Inc. on June 30, 2025; TBS-2025 is a VISTA inhibiting monoclonal antibody moving into Phase 2 development for mutNPM1 r/r AML [1] - The company is also leveraging Delta Opioid Receptor technology to develop first-in-class bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells [1]

Core Insights - TuHURA Biosciences, Inc. has received Orphan Drug Designation from the FDA for its product IFx-2.0, aimed at treating stage IIB to stage IV cutaneous melanoma [1][3] - The designation is based on positive results from a Phase 1 study, which indicated that IFx-Hu2.0 is safe and provides clinical benefits to patients who are refractory to checkpoint inhibitor therapy [2] - The company is currently focused on completing enrollment for a Phase 3 study of IFx-2.0 in combination with Keytruda® for advanced or metastatic Merkel Cell Carcinoma [3] Company Overview - TuHURA Biosciences is a Phase 3 immuno-oncology company that develops novel therapeutics to address resistance to cancer immunotherapy [4] - The lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is being tested in a randomized Phase 3 trial [5] - The company has also acquired TBS-2025, which is moving into Phase 2 development for mutNPM1 r/r AML, and is developing bi-specific antibody drug conjugates targeting immune-suppressing cells in the tumor microenvironment [6]

Core Insights - TuHURA Biosciences, Inc. has achieved a milestone in its clinical trial for REM-001, demonstrating safety and signs of clinical efficacy in ten metastatic cutaneous breast cancer patients after eight weeks of follow-up [1][2] Group 1: Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to address resistance to cancer immunotherapy, a significant challenge in cancer treatment [3] - The company's lead product, IFx-2.0, aims to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 trial as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [4] Group 2: Recent Developments - Following the successful completion of the REM-001 trial, TuHURA will release an aggregate of 1,539,958 shares of common stock to legacy Kintara Therapeutics stockholders as per the Contingent Value Rights Agreement [2] - TuHURA has also acquired TBS-2025 through its merger with Kineta Inc., which is moving into Phase 2 development for mutNPM1 r/r AML [5]

Core Insights - TuHURA Biosciences is advancing its Phase 3 program of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced Merkel cell carcinoma, with enrollment completion targeted for Q4-2026 [1][13] - The company raised $15.6 million in a recent equity financing transaction, providing a cash runway to achieve key milestones across its development programs [1][2] - A mini KOL symposium highlighted the potential of targeting VISTA in acute myeloid leukemia (AML) and the combination with menin inhibitors for NPM1 mutated relapsed/refractory AML [1][3] Company Developments - The Phase 3 trial of IFx-2.0 has been initiated, marking a significant step in the company's strategy to address resistance to cancer immunotherapy [2][13] - The merger with Kineta has added a Phase 2 ready VISTA inhibiting antibody to the company's pipeline, enhancing its therapeutic offerings [2][14] - Preliminary data from the IFx-2.0 basket trial and insights on inhibiting Delta Opioid Receptor (DOR) are expected to be presented at scientific conferences in 2026 [3] Clinical Insights - VISTA is identified as the only checkpoint significantly upregulated in AML, particularly in high-risk subtypes, contributing to low response rates in patients treated with menin inhibitors [11] - The combination of TBS-2025 (VISTA inhibiting antibody) with menin inhibitors shows promise in improving survival outcomes in murine models of AML [11] - Key opinion leaders expressed enthusiasm for the potential of TBS-2025 in combination therapies for high-risk AML and patients unfit for intensive treatments [3][11]

Core Viewpoint - TuHURA Biosciences, Inc. has announced a definitive agreement for a registered direct offering to raise capital through the sale of common stock and warrants, aimed at funding working capital and addressing a bridge note obligation [1][4]. Group 1: Offering Details - The company will sell a total of 9,462,423 shares of common stock at a price of $1.65 per share, along with Series A and Series B warrants for the same number of shares [1]. - The offering will occur in three tranches: the first closing on or about December 10, 2025, the second by January 30, 2026, and the third by February 27, 2026 [3]. - The gross proceeds from the first closing are expected to be approximately $8.6 million, $5 million from the second closing, and $2 million from the third closing, before deducting fees and expenses [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for working capital, to satisfy a $3.4 million bridge note obligation, and for general corporate purposes [4]. - The bridge note obligation carries an interest rate of 3% per month and requires repayment by December 31, 2025, or within 30 days after a successful equity financing exceeding $12 million [4]. Group 3: Company Overview - TuHURA Biosciences, Inc. is focused on developing novel therapeutics to overcome resistance to cancer immunotherapy, particularly in advanced or metastatic Merkel Cell Carcinoma [7][8]. - The company’s lead product, IFx-2.0, is currently in a Phase 3 trial as an adjunctive therapy to Keytruda® [8]. - TuHURA has also acquired TBS-2025, which is moving into Phase 2 development for a specific type of leukemia, and is developing innovative antibody drug conjugates targeting immune-suppressing cells in the tumor microenvironment [9].

Core Insights - TuHURA Biosciences presented new scientific evidence at the 67th American Society of Hematology Annual Meeting, highlighting the role of Delta Opioid Receptor (DOR) in modulating the immunosuppressive capabilities of Myeloid-Derived Suppressor Cells (MDSCs) and Tumor-Associated Macrophages (TAMs) [1][2][3] Group 1: DOR and MDSCs - DOR is expressed on MDSCs, and its inhibition reduces their immune suppressing capabilities by downregulating multiple genes associated with immunosuppression [1][2] - Pharmacological antagonism of DOR has been shown to reverse T cell suppression, indicating that DOR may serve as a novel target for reprogramming MDSC-induced immunosuppression in the tumor microenvironment [2][4] Group 2: DOR and TAMs - DOR is also expressed on TAMs, and targeting DOR can potentially reverse TAM-mediated T cell suppression, which may help overcome resistance to checkpoint inhibitors and other cancer immunotherapies [1][3] - The study indicates that the tumor microenvironment induces DOR upregulation in TAMs compared to peripheral macrophages, suggesting a promising strategy for reprogramming these suppressive cells [3][4] Group 3: Company Developments - TuHURA has developed a library of highly selective DOR antagonists and is advancing its first-in-class immune-modulating bi-functional, bi-specific antibody drug conjugates (ADCs) [4][5] - The lead ADC candidate is expected to consist of a DOR inhibitor conjugated to a VISTA inhibiting antibody, aiming to alleviate the immunosuppressive tone of the tumor microenvironment and enhance T cell activity [4][5][6] Group 4: Clinical Trials and Future Directions - TuHURA has initiated a Phase 3 trial for its innate immune agonist, IFx-2.0, as an adjunctive therapy to Keytruda for advanced or metastatic Merkel Cell Carcinoma [6][7] - The company is also developing TBS-2025, a VISTA inhibiting mAb asset, which is moving into Phase 2 development for mutNPM1 r/r AML [7]