OS Therapies Inc. reported its third quarter 2025 financial results and provided a business update for the period ended September 30, 2025. The company highlighted that it remains eligible for a Priority Review Voucher (PRV) based on Pediatric Rare Pediatric Disease Designation (RPDD) for osteosarcoma if OST-HER2 is approved by September 30, 2026. OS Therapies announced that a Type C meeting with the US FDA is scheduled for December 11, 2025, following the August 27, 2025 End of Phase 2 meeting, to address key items regarding the Phase 2b clinical trial of OST-HER2 for the prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma. The company expects to file US Biologics Licensing Application (BLA) and UK MHRA Marketing Authorization Application $(MAA)$ for OST-HER2 in January 2026, leveraging Project Orbis. Additionally, the company recently completed a $7.8 million warrant exercise inducement, providing capital into late 2026 by delaying the launch to 2027. OS Therapies also reported that biomarker data for OST-HER2 are expected to be available for upcoming FDA and MHRA meetings, which will inform post-market confirmatory clinical development and market surveillance commitments. The company is also anticipating data from its OST-504 Phase 1b program in castration resistant prostate cancer and intends to seek FDA Platform Designation for its listeria cancer immunotherapy platform when eligible.