OS Therapies Secures $11.2M Q1 Funding and Aligns on Phase 3 Survival Endpoint
OS Therapies raised $11.2M in Q1 through a $5.5M direct offering and $5.7M financing, securing cash runway into 2027 alongside $4.5M of maturing UK VAT refunds and R&D credits, including a $1.9M VAT refund in June 2026. EMA and Australia TGA aligned on a Phase 3 protocol for OST-HER2 with 3-year overall survival as primary endpoint, while 2.5-year survival data are expected at ASCO 2026 to support Conditional Marketing Authorization.
1. First Quarter Financing and Cash Position
OS Therapies raised $5.5 million in a registered direct offering on April 2 and $5.7 million from warrant inducement and bridge financings, extending cash runway into 2027. The company also expects to collect $4.5 million in UK VAT refunds and R&D tax credits, including a $1.9 million VAT refund in June 2026.
2. Regulatory Alignment on Phase 3 Protocol
The European Medicines Agency and Australia TGA have aligned on key design aspects of the Phase 3 metastatic osteosarcoma trial, designating 3-year overall survival as the primary efficacy endpoint. OS Therapies plans U.S. FDA Type C and U.K. MHRA SAM meetings to confirm these endpoints and pursue rolling review and RMAT designation.
3. Upcoming Data Readouts and Milestones
OS Therapies will present 2.5-year overall survival data at ASCO 2026 and is preparing for a U.S. FDA Pre-BLA meeting to finalize clinical and biomarker endpoints. The company also filed an S-1 for a Go-Public transaction of its Animal Health subsidiary, pending a planned USDA regulatory meeting.