(MENAFN- Newsfile Corp) Dallas, Texas--(Newsfile Corp. - November 21, 2025) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners updates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced key clinical, regulatory, and commercial milestones in 3Q25 as it moves closer to bringing OST-HER2 to patients with recurrent, fully resected, pulmonary metastatic osteosarcoma. Final 2-year OS data from the 41-patient Phase 2b trial showed a 2-year OS rate of 75% for OST-HER2 vs 40% in historical controls, with 100% 2-year survival among patients event-free at 12 months, reinforcing durable benefit. Building on a successful End-of-Phase 2 interaction, management is preparing harmonized U.S./ex-U.S. filings with UK MHRA and FDA submissions expected around year-end, supported by its Eversana partnership and a launch plan that anticipates initial PRV monetization in 2026 and commercial OST-HER2 revenues beginning in early 2027. Subsequent to quarter-end, the Company also announced its intent to spin off OS Animal Health (OSAH) into a separately financed, standalone public company in 1H26, with OSTX shareholders expected to receive direct equity participation in the new listing.

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Key Takeaways:

• Regulatory path on track with UK pre MAA in December and FDA Type C on December 11 filings targeted for January 2026 supported by Phase 2b showing 2 year OS 75% vs 40% and PRV eligibility in 2026.
• Planned spinoff of OS Animal Health in 1H26 gives shareholders direct equity and advances the canine OST HER2 franchise.
• Quarter ended with ~$1.9M cash, net loss $6.9M and post quarter $7.8M warrant proceeds and ATM in place extending runway into late 2026.

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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.

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