Core Insights - TuHURA Biosciences is advancing its clinical programs, including the initiation of a Phase 3 trial for IFx-Hu2.0 in combination with Keytruda for advanced Merkel cell carcinoma (MCC) [1][3] - The company is targeting the acquisition of Kineta, Inc. and plans to initiate a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated acute myeloid leukemia (AML) [2][3] Clinical Development - TuHURA has initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in patients with Merkel cell carcinoma of unknown primary origin (MCCUP) [1][4] - The Phase 3 trial for IFx-Hu2.0 is expected to begin in Q2 2025, pending the lifting of a partial clinical hold by the FDA [3][10] - The Phase 1b/2a trial will include patients with deep-seated tumors who are not eligible for the Phase 3 trial, addressing a significant patient population [3][4] Financial Overview - For the first quarter ended March 31, 2025, research and development expenses were $4.6 million, compared to $3.6 million for the same period in 2024 [6] - General and administrative expenses increased to $2.4 million in Q1 2025 from $1.0 million in Q1 2024 [6] Corporate Updates - TuHURA is in the process of acquiring Kineta, Inc., with the deal expected to close in Q2 2025, subject to financing and other conditions [2][8] - The company appointed Dr. Bertrand Le Bourdonnec as Head of Drug Discovery and Dr. Craig L. Tendler to its Board of Directors, enhancing its leadership team [10] Upcoming Milestones - Q2 2025: Anticipated initiation of the Phase 3 trial for IFx-Hu2.0 and closing of the Kineta acquisition [10] - Q3 2025: Planned initiation of a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated AML [10]
TuHURA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides a Corporate Update