Dallas, Texas--(Newsfile Corp. - September 8, 2025) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners initiates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced meaningful clinical, regulatory, and financial milestones in 2Q25 as it moves closer to bringing OST-HER2 to patients with recurrent, fully resected, pulmonary metastatic osteosarcoma. Importantly, the FDA confirmed that OST-HER2 meets the biological definition of a Regenerative Medicine Advanced Therapy (RMAT) and issued a Biologics License Application (BLA) number in preparation for an Accelerated Approval submission. Final 12-month Event Free Survival (EFS) results from the Phase 2b trial demonstrated statistically significant improvement, supported by interim 2-year Overall Survival (OS) data, further validating the clinical benefit. With a U.S. commercial partnership secured with Eversana, OS Therapies is positioning for a potential U.S. launch in the first half of 2026.

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Key Takeaways:

• Following a successful FDA End of Phase 2 meeting, OSTX is on track to begin rolling BLA submission for OST-HER2 in September 2025.
• Phase 2b trial showed statistically significant improvements in 12-month Event Free Survival (35% vs. 20%) and interim 2-year Overall Survival (66.6% vs. 40%), with an excellent safety profile.
• Completed warrant exchange financings raising ~$7.9M in Q3, extending cash runway into 2027 and funding commercial launch preparations.

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About Stonegate

Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.

Source: Stonegate, Inc.

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