DALLAS, TX -- September 8th, 2025 -- OS Therapies Inc. (NYSE: OSTX): Stonegate Capital Partners initiates their coverage on OS Therapies Inc. (NYSE: 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. 

Company Updates:

Pipeline Overview: OST-HER2 remains the Company’s lead program. The therapy, built on a listeria-based immunotherapy platform, has demonstrated compelling efficacy in osteosarcoma, an area with no new FDA-approved therapies in over 40 years. Beyond osteosarcoma, OS Therapies expanded its portfolio by acquiring Ayala’s listeria immunotherapy platform, which adds four additional clinical-stage and eight pre-clinical-stage programs. The Company also formed OS Animal Health, a subsidiary to explore applications of OST-HER2 in canine osteosarcoma, supported by positive veterinary trial data.

Regulatory Advancements: In August 2025, OS Therapies held a productive End of Phase 2 Meeting with the FDA, aligning on CMC and non-clinical matters, and confirming no safety concerns with OST-HER2. The Company remains on track to begin rolling BLA submissions in September 2025. Internationally, OS Therapies has submitted an ILAP to the UK MHRA and scheduled an EMA rapporteur meeting in October 2025, with the agencies signaling an intent to synchronize reviews via Project Orbis. If approved before September 30, 2026, OST-HER2’s rare pediatric disease designation could qualify the Company for a Priority Review Voucher (PRV), potentially monetizable at ~$155–160M based on recent transactions.

Financial Performance: For 2Q25, OS Therapies reported a net loss of $4.5M, compared to $1.6M in 2Q24, reflecting increased R&D and G&A expenses related to clinical and regulatory progress. Cash stood at $2.8M at quarter-end, with recent financing extending runway into 2027. Specifically, the Company raised $4.2M in July 2025 through a warrant exchange and inducement, completed an additional $3.7M warrant exchange in September 2025, and subsequently terminated its equity line of credit, citing reduced burn rate and sufficient liquidity. Management expects this strengthened balance sheet, combined with the potential monetization of a PRV, to provide a multi-year capital runway to support commercialization.

Valuation: We use a probability-adjusted Discounted Cash Flow Model when valuing OSTX. Our valuation model returns a valuation range of $7.09 to $9.94 with a midpoint of $8.29 based on a discount rate range of 12.50% to 17.50%. We note that this model is highly levered to the out years due to the long term nature of OSTX’s industry, leading to the potential for dramatic re-ratings as new information becomes available.

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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