Dallas, Texas--(Newsfile Corp. - May 12, 2026) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners updates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced materially through late-stage regulatory and commercialization preparation as OST-HER2 moved from Phase 2bsupported planning toward a more defined global approval pathway in recurrent, fully resected, pulmonary metastatic osteosarcoma. The key change is greater regulatory clarity: EMA initiated rolling review of the OSTHER2 Conditional Marketing Authorization dossier, while EMA and Australia's TGA aligned on 3-year overall survival as the approvable efficacy endpoint. Management also positioned seroconversion biomarker data as supportive surrogate efficacy evidence, shifting the investment debate from early proof-of-concept toward execution across a dense 2026 catalyst calendar. Key milestones include 2.5-year OS data in mid-2Q26, FDA/MHRA meetings in 2Q26, Phase 3 initiation in Australia in 3Q26, 3-year OS data in early 4Q26, and a potential EMA CMA decision in 4Q26.

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Key Takeaways:

• Regulatory clarity is the core value inflection. EMA rolling review, TGA endpoint alignment, MHRA ATMP designation, and 2026 FDA/MHRA meetings shift OST-HER2 from Phase 2b validation toward an executable global approval pathway.
• Survival data remain the key catalyst stack. Mid-2Q26 2.5-year OS data and early-4Q26 3-year OS data should determine whether OSTX can complete EMA CMA submission and sustain accelerated-access momentum.
• Financing/PRV optionality bridges the regulatory window. The $5.25M raise plus expected $4.0M non-dilutive funding supports 2026 catalysts, while a potential PRV remains a meaningful approval-contingent valuation lever, with the latest public transaction at $205M.

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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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