TuHURA Biosciences (HURA) Registration filing summary

Company overview and business model

• Clinical-stage immuno-oncology company focused on overcoming resistance to cancer immunotherapies through three core technology platforms: IFx innate immune agonists, TBS-2025 VISTA-inhibiting monoclonal antibody, and Delta Opioid Receptor (DOR) modulators targeting myeloid-derived suppressor cells (MDSCs).

• Lead product IFx-2.0 is in a Phase 3 trial for advanced/metastatic Merkel cell carcinoma as adjunctive therapy to pembrolizumab, using the FDA's accelerated approval pathway.

• Acquired Kineta, Inc. in June 2025, adding TBS-2025 (formerly KVA1213), a VISTA-inhibiting antibody, with plans for a Phase 2 trial in AML.

• DOR technology is being developed for bi-specific antibody-peptide and antibody-drug conjugates to modulate the tumor microenvironment and prevent resistance to immunotherapies.

Financial performance and metrics

• Reported net losses of $22.6 million for 2024 and $29.3 million for 2023; accumulated deficit of $127.3 million as of June 30, 2025.

• Cash and cash equivalents of $8.5 million as of June 30, 2025; additional $3.0 million received in July 2025 from private placement.

• Research and development expenses increased to $13.3 million in 2024 from $9.4 million in 2023, driven by clinical development and personnel costs.

• General and administrative expenses were $4.3 million in 2024, up slightly from $4.1 million in 2023.

• No product revenue to date; operations funded primarily through equity and convertible note financings.

Use of proceeds and capital allocation

• Net proceeds from the June 2025 private placement are allocated to fund the Kineta acquisition, initiate the IFx-2.0 Phase 3 trial, advance TBS-2025 to Phase 2, and for working capital.

• Proceeds from warrant exercises and prior financings used for ongoing R&D, clinical trials, and operational expenses.