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OS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates

Newsfile Corp•17/08/2026•07:40 ET
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* Up to $10 million debt financing supported by U.K. subsidiary VAT refunds and reimbursable R&D tax credits, including $5 million funded at the August 10, 2026 first closing * FDA Type C Statistical Methods Meeting mid-September 2026 meeting to review 2.5-year Overall Survival data and confirmatory Phase 3 trial design to gain alignment on statistical analysis plan for BLA submission under the Accelerated Approval Program * Interim 3-year Overall Survival data expected in early September 2026 ahead of MHRA Statistical Methods Scientific Advice Meeting for Conditional MAA submission acceptance criteria * Final 3-year Overall Survival data to be included in FDA BLA Accelerated Approval Program submission ahead of Type B Pre-BLA Meeting previously granted in Q2/26 * U.K. waives Pediatric Investigation Plan (PIP) requirement New York and Rockville, Maryland--(Newsfile Corp. - August 17, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today reported financial results for the second fiscal quarter ended June 30, 2026, and provided business and regulatory updates. The Company is seeking to obtain a Biologics License Application (BLA) under the Accelerated Approval Program of the U.S. Food & Drug Administration (FDA), and equivalent Conditional Marketing Accelerated Authorisations (CMAAs) from the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA), for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program").

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