TAMPA, Fla., April 1, 2026 /PRNewswire/ — TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA” or the “Company”), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today reported financial results for the Company’s fourth quarter and full year ended December 31, 2025, and provided a corporate update.
“2025 was a strong year of executing upon our goals, and we continue to move all our programs forward this year. As we progress our clinical development pipeline, we have strategically strengthened our clinical and drug development expertise with Craig Tendler, M.D., providing the strategic and operational services consistent with those of a Chief Medical Officer to oversee clinical development strategy and operations of the company’s pipeline, including our VISTA inhibiting antibody, TBS-2025,” said Dr. James Bianco, President and CEO of TuHURA Biosciences. “Craig brings a depth of experience that is invaluable to us as we look forward to several targeted key milestones in our VISTA program this year. Our IFx-2.0 Phase 3 study in front-line Merkel Cell Carcinoma (MCC) continues to enroll, and we now anticipate completing enrollment in mid-2027. Additionally, we continue to make important advancements toward preclinical proof-of-concept in our first-in-class immune modulating antibody drug conjugates (ADC) program and anticipate presenting new data at a scientific conference later this year.”
Dr. Bianco continued, “We are grateful to have the unwavering support of our shareholders, who are committed to supporting our programs and realizing the potentially meaningful opportunity each one addresses.”
Corporate Highlights
- Initiated a randomized Phase 3 Accelerated Approval Trial for IFx-2.0 in first line treatment of patients with advanced or metastatic Merkel Cell Carcinoma (MCC) as adjunctive therapy to Keytruda® (pembrolizumab). Phase 3 study trial being conducted under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA). Primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval process. Key secondary endpoint of Progression Free Survival (PFS) may satisfy the requirement for a post confirmatory trial, converting accelerated approval to regular approval.
- Initiated Phase 1b/2a Study of IFx-2.0 as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP). Trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda® when administered via Interventional Radiology (IR) in patients with deep- seated tumors without associated cutaneous tumors.
- Closed acquisition of Kineta gaining rights to TBS-2025, a novel VISTA inhibiting antibody, for $10.5 million.