Core Insights - Stonegate Capital Partners has initiated coverage on OS Therapies Inc. (OSTX), highlighting significant clinical, regulatory, and financial advancements in Q2 2025 as the company approaches the launch of OST-HER2 for patients with recurrent, fully resected, pulmonary metastatic osteosarcoma [1][3] Clinical and Regulatory Developments - The FDA has confirmed that OST-HER2 qualifies as a Regenerative Medicine Advanced Therapy (RMAT) and has issued a Biologics License Application (BLA) number in preparation for an Accelerated Approval submission [1][3] - Final 12-month Event Free Survival (EFS) results from the Phase 2b trial showed a statistically significant improvement of 35% compared to 20%, alongside interim 2-year Overall Survival (OS) data of 66.6% versus 40%, indicating strong clinical benefits [5] Financial Position and Partnerships - OS Therapies has secured a U.S. commercial partnership with Eversana, positioning for a potential U.S. launch in the first half of 2026 [1][3] - The company completed warrant exchange financings raising approximately $7.9 million in Q3, extending its cash runway into 2027 and funding preparations for the commercial launch [5]
Stonegate Capital Partners Initiates Coverage on OS Therapies Inc. (OSTX)