New York, New York — August 19, 2025 — Leads & Copy — OS Therapies Inc. (NYSE American: OSTX) reported that the U.S. Food and Drug Administration (FDA) has confirmed OST-HER2 meets the biological definition of Regenerative Medicine Advanced Therapy (RMAT). The FDA issued an OST-HER2 Biologics License Application (BLA) number in preparation for an Accelerated Approval submission following an End of Phase 2 Meeting scheduled for August 27, 2025.
The meeting will review the Phase 2b clinical trial in the prevention or delay of recurrent, pulmonary metastatic osteosarcoma. Data from the trial showed a statistically significant 12-month Event Free Survival, interim 2-year Overall Survival, and a strong safety profile, driving global accelerated/conditional approval pathways. OS Therapies’ commercial partnership with Eversana positions OST-HER2 for a possible U.S. launch in the first half of 2026. The company’s $4.2 million capital raise, closed July 11, 2025, extends its cash runway into mid-2026.
Second quarter 2025 corporate highlights include statistically significant benefits from the Phase 2b clinical trial, a strong safety profile, an osteosarcoma U.S. commercial partnership with Eversana, and a new U.S. Patent & Trademark Office patent providing exclusivity for the listeria cancer immunotherapy platform through 2040. OS Therapies also submitted an International Nonproprietary Name request to the World Health Organization for OST-HER2, completed the acquisition of the listeria cancer immunotherapy platform from Ayala Pharmaceuticals, and formed a subsidiary, OS Animal Health, to further strategic alternatives for the use of OST-HER2 in canine osteosarcoma.
Recent progress includes FDA confirmation that OST-HER2 meets the biological criteria to qualify as a “Regenerative Medicine Advanced Therapy,” issuance of a BLA number for OST-HER2, and updated interim 2-year overall survival data showing a statistically significant benefit. Additionally, the company submitted an Innovative Licensing and Access Pathway (ILAP) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., granted a rapporteur meeting with the European Medicines Agency (EMA) to begin the regulatory approval process in Europe, closed a warrant exercise inducement and exchange offering, and saw its NYSE American-listed OSTX common stock included in the Russell Microcap indexes.
Upcoming milestones include the End of Phase 2 Meeting with the FDA, projected initiation of BLA submission in late Q3 2025, a rapporteur meeting with the EMA in October 2025, and potential regulatory approval for OST-HER2 in the U.S. and U.K. as early as year-end 2025.
The Company recorded a net operating loss of $4.537 million in the second quarter of 2025.
Investor Relations Contact: Harrison Seidner, PhD, WaterSeid Partners, OSTX@waterseid.com
Public Relations Contact: Stephanie Chen, Elev8 New Media, stephanie@elev8newmedia.com
