Core Insights - TuHURA Biosciences is advancing its Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda for advanced Merkel cell carcinoma, with potential for accelerated and regular FDA approval [2][7] - The company is also preparing to submit a Phase 2 study protocol for TBS-2025, a VISTA inhibiting antibody, targeting NPM1 mutated acute myeloid leukemia (AML) [2][8] - TuHURA's Delta Opioid Receptor (DOR) technology has been recognized for its potential in overcoming resistance to cancer immunotherapy, with presentations scheduled at the ASH 2025 Annual Meeting [3][15] Clinical Development - The Phase 3 trial of IFx-2.0 is designed to evaluate its effectiveness as an adjunctive therapy to pembrolizumab in first-line treatment for advanced or metastatic Merkel cell carcinoma [7] - The company is on track to submit the Phase 2 plan for TBS-2025 to the FDA next month and aims to initiate the trial in the first quarter of next year [2][8] Financial Performance - For the third quarter ended September 30, 2025, research and development expenses were reported at $4.9 million, compared to $2.9 million for the same period in 2024 [5] - Net cash outflows from operating activities for the nine months ended September 30, 2025, were ($22.1) million, up from ($12.1) million in 2024 [5] Corporate Developments - TuHURA appointed Dr. Michael Turner as Vice President of Immunology, bringing over 20 years of experience in the field [3] - The company has filed for a $50 million At-The-Market (ATM) facility, allowing it to sell shares under the facility once the registration statement becomes effective [3] Upcoming Milestones - Anticipated milestones include preliminary results from the Phase 1b/2a trial of IFx-2.0 in Q2 2026 and completion of enrollment in the Phase 3 trial by Q4 2026 [11] - The company expects to initiate the Phase 2 trial of TBS-2025 in combination with a menin inhibitor in Q1 2026 [11]
TuHURA Biosciences, Inc. Reports Third Quarter 2025 Financial Results and Provides a Corporate Update