Core Viewpoint - OS Therapies reported its third quarter 2025 financial results and highlighted significant upcoming regulatory milestones for its lead product, OST-HER2, which is aimed at treating osteosarcoma and other HER2-related cancers [3][4]. Financial Results - The company recorded a net operating loss of $6.879 million in Q3 2025, compared to a net operating loss of $2.875 million in Q3 2024, primarily due to pre-commercial activities related to the OST-HER2 program [6]. - Net loss per share was $0.21 on 31.956 million outstanding shares in Q3 2025, compared to a net loss of $0.18 per share on 15.897 million shares in Q3 2024 [6]. Regulatory Updates - A Type C meeting with the US FDA is scheduled for December 11, 2025, to discuss key items following the End of Phase 2 meeting regarding the OST-HER2 clinical trial [5][8]. - The company expects to file a Biologics Licensing Application (BLA) for OST-HER2 in January 2026, leveraging feedback from upcoming regulatory meetings [4][5]. - The UK MHRA pre-Marketing Authorization Application (MAA) meeting is set for December 8, 2025, in preparation for the January 2026 MAA filing [5][8]. Clinical Development - OST-HER2 has shown promising results in its Phase 2b trial, with a reported 2-year overall survival rate of 75% compared to a historical control of 40% (p < 0.0001) [8]. - The company anticipates that accelerated approval for OST-HER2 could catalyze further clinical development in osteosarcoma and other HER2-related cancers [4][6]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, which features tunable antibody-linker-payload candidates [10]. Future Outlook - The company expects to receive a Priority Review Voucher (PRV) if OST-HER2 is approved by September 30, 2026, which could be sold for additional revenue [5][9]. - Increased compassionate use requests have been noted, primarily from clinical sites involved in the Phase 2b trial, indicating growing interest and potential market demand for OST-HER2 [4].