Core Insights - OS Therapies Inc. (OSTX) is advancing towards bringing OST-HER2 to patients with recurrent, fully resected, pulmonary metastatic osteosarcoma, with significant clinical and regulatory milestones achieved in 3Q25 [1][3] - The company reported a 2-year overall survival (OS) rate of 75% for OST-HER2 compared to 40% in historical controls, with 100% 2-year survival among patients who were event-free at 12 months [1][5] - A planned spinoff of OS Animal Health (OSAH) into a standalone public company is expected in 1H26, allowing OSTX shareholders to receive direct equity participation [1][5] Regulatory Developments - The regulatory path is on track with a UK pre-MAA submission in December and FDA Type C filings targeted for January 2026, supported by the Phase 2b trial results [5] - The company is preparing for harmonized U.S. and ex-U.S. filings, with submissions to the UK MHRA and FDA expected around year-end [1][5] Financial Overview - As of the end of the quarter, OS Therapies had approximately $1.9 million in cash and reported a net loss of $6.9 million [5] - Post-quarter, the company secured $7.8 million in warrant proceeds and has an At-The-Market (ATM) facility in place, extending its financial runway into late 2026 [5]