OS Therapies Third Quarter 2026 Corporate Outlook

About this update from Os Therapies Incorporated

Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access New York, New York and Rockville, Maryland--(Newsfile Corp. - July 6, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company") , the world leader in gene-edited, Listeria-based cancer immunotherapies, today provides a third quarter 2026 corporate outlook. The outlook focuses on upcoming clinical and regulatory milestones for the Company's lead program OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program"), advancements with the Company's animal health-focused subsidiary OS Animal Health, Inc. (OSAH) and the Company's financial position as key regulatory and corporate milestones come into focus. OST-HER2 Metastatic Osteosarcoma Program OS Therapies recently announced full alignment with the European Medicines Agency (EMA), the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and Australia's Therapeutic Goods Administration (TGA) with respect to the necessary requirements to be granted Conditional Marketing Authorisation Applications (CMAAs). The key outstanding milestones are 3-year overall survival data, which EMA, MHRA and TGA have aligned around to support early market access, and the Pediatric Investigation Plans (PIP) for each jurisdiction. Prior to being granted CMAAs in Europe, the U.K. or Australia, the Company must have commenced a confirmatory Phase 3 clinical study. This Phase 3 study is expected to initiate towards the end of the third quarter of 2026, initially in Australia only and after early market access is decided upon then in the U.K., Europe and the United States. MHRA and TGA have both agreed to allow the Company to initiate the Phase 3 study with the same OST-HER2 drug product batch that was used in the Phase 2b trial and is currently being administered to Expanded Access patients in the United States. Full alignment has been reached with EMA, MHRA and TGA in the following areas: OS Therapies was granted Advanced Therapy Medicinal Products (ATMP) designation in Europe and the U.K., which permitted access to additional resources from local regulators to support CMAA submissions. The Company is making significant progress towards alignment on the PIP – including a first round of positive feedback from the EMA PDCO - and has received a submission window of September 30, 2026 from EMA for the CMAA. With MHRA and TGA, the Company is in ongoing dialogue to identify the earliest possible date to complete CMAA submissions and is making significant progress towards PIPs.

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