TuHURA Biosciences advances Phase 3 immunotherapy trial and secures key oncology assets

TuHURA Biosciences (NASDAQ:HURA) provided a comprehensive corporate and financial update for the fiscal year ended December 31, 2025, on Wednesday, April 1, 2026.

The company’s report underscores a year of aggressive clinical advancement and strategic asset acquisition as it moves toward pivotal milestones in the immuno-oncology space.

A primary operational highlight for the year was the progression of the Phase 3 trial for IFx-2.0, a personalized cancer vaccine candidate.

The trial, which targets first-line Merkel Cell Carcinoma (MCC), is being conducted under a Special Protocol Assessment (SPA) with the FDA, significantly de-risking the regulatory path forward.

Management noted that the SPA agreement aligns the company with the agency on the trial’s design, endpoints, and statistical analysis, providing a clearer trajectory toward potential approval.

Strategic business development also played a critical role in 2025.

TuHURA successfully completed a $10.5 million acquisition of the rights to TBS-2025 from Kineta.

This acquisition broadens the company’s portfolio of next-generation checkpoint inhibitors and is expected to move into clinical evaluation as part of a series of planned milestones through 2027.

On the financial front, TuHURA reported $3.6 million in cash and cash equivalents as of December 31, 2025.

During the fiscal year, the company invested $20.5 million in research and development (R&D) and $7.6 million in general and administrative (G&A) expenses.

Net operating cash outflows for the year totaled $27.7 million, offset in part by $21.2 million in gross proceeds raised through various 2025 financing activities.