Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (NYSE: OSTX)

<p class='reportable-dateline'><strong>DALLAS, TX -- MAY 12, 2026</strong></p><p class='reportable-excerpt'>DALLAS, TX -- May 12, 2026 -- OS Therapies Inc. (NYSE: OSTX): Stonegate Capital Partners updates their coverage on OS Therapies Inc. (NYSE: 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.</p><p>To view the full announcement, including downloadable images, bios, and more, <a href='https://stonegateinc.reportablenews.com/pr/stonegate-capital-partners-updates-coverage-on-os-therapies-inc-nyse-ostx' class='reportable-link'>click here</a>.</p><div class='reportable-key-takeaways'><h3>Key Takeaways:</h3><ul><li>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.</li><li>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.</li><li>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.</li></ul></div><a href='https://stonegateinc.reportablenews.com/pr/stonegate-capital-partners-updates-coverage-on-os-therapies-inc-nyse-ostx'><img src='https://cdn.filestackcontent.com/37gg8t1tRbuHuQmLN5Hs' class='reportable-featured-image' /><p align='center'><i>Click image above to view full announcement.</i></p></a><hr class='company-boilerplate-rule' style='border: 0; border-top: 1px solid rgba(0,0,0,0.1);'><p class='company-boilerplate'><p><strong>About Stonegate<br></strong>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.</p></p><div class='reportable-contacts'><h3>Contacts:</h3><p class='reportable-contact'>Stonegate Capital Partners<br>(214) 987-4121 <br><a href='mailto:info@stonegateinc.com'>info@stonegateinc.com</a></p></div><p>Source: <a href='https://stonegateinc.reportablenews.com/'>Stonegate, Inc.</a></p><p>Distributed by: <a href='https://reportablenews.com'>Reportable, Inc.</a></p>