other material
confidence high
sentiment positive
materiality 0.75
TuHURA plans IFx-2.0 Phase 3 trial under SPA; signs non-binding LOI to acquire Kineta's KVA12123
TuHURA Biosciences, Inc./NV
- IFx-2.0 Phase 3 accelerated approval trial in first-line MCC to start H1 2025 under FDA SPA, with ORR primary and PFS secondary endpoints.
- Non-binding LOI with Kineta to acquire KVA12123 VISTA antibody via merger; definitive agreement targeted Q4 2024.
- Cash runway expected to fund operations late into H2 2025; $31M from Kintara merger plus $5M for Kineta exclusivity.
- Hired Peter O'Neill as VP Clinical Operations and Michael Krsulich as Head of Quality Assurance.
- REM-001 photodynamic therapy study for cutaneous metastatic breast cancer enrollment expected to complete Q4 2024.