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.
To view the full announcement, including downloadable images, bios, and more, click here.
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.
Click image above to view full announcement.
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.
Contacts:
Stonegate Capital Partners
(214) 987-4121
info@stonegateinc.com
Source: Stonegate, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/275571