TuHURA Biosciences Inc (NASDAQ: HURA) is a clinical-stage immuno-oncology company developing therapies designed to overcome primary and acquired resistance to cancer immunotherapies. The company generates no product revenue and funds operations through equity financing and grants, as it has no approved products as of the 10-K filed March 31, 2026 (FY2025). TuHURA's pipeline is built around two platforms: the proprietary Immune Fx (IFx) innate immune agonist technology, designed to make tumor cells appear bacterial to the immune system, and TBS-2025, an anti-VISTA checkpoint inhibitor acquired through the Kineta merger. Lead candidates include IFx-2.0 (clinical stage), TBS-2025 (Phase 1, with a recommended Phase 2 dose of 750 mg every two weeks identified as of FY2025), and preclinical programs IFx-3.0 and REM-001. Research and development expenses rose in FY2025, driven by approximately $0.6 million in TBS-2025 clinical development, approximately $0.9 million in preclinical research, and approximately $4.6 million in personnel and facilities costs. The company holds exclusive licenses from H. Lee Moffitt Cancer Center, originally executed in 2019 and 2021.
IFx-2.0: clinical-stage innate immune agonist targeting solid tumors. TBS-2025: anti-VISTA checkpoint inhibitor in Phase 1, recommended Phase 2 dose of 750 mg every two weeks (FY2025). IFx-3.0: preclinical innate immune agonist. REM-001: preclinical program. MDSC (myeloid-derived suppressor cell) research: preclinical stage.
No product revenue. Operations are funded through equity issuances, Series A Preferred Stock, and grant income. The company received a $0.1 million Employee Retention Tax Credit in FY2025. All spending is pre-commercial.
No commercial customers. End market is oncology, specifically patients with cancers resistant to existing immunotherapies. Clinical trial participants are the current end users of investigational compounds.
Operations based in the United States. Intellectual property protection noted as a concern in certain foreign jurisdictions per FY2025 10-K filing.
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