OS Therapies to Showcase at Investor Conferences in September 2025

OS Therapies announced participation in upcoming investor conferences: Cantor Global Healthcare Conference 2025, H.C. Wainwright 27th Annual Global Investment Conference, and Lake Street Capital Markets 9th Annual Best Ideas Growth Conference. The company is a clinical-stage cancer immunotherapy and antibody drug conjugate biotech focused on treatments for osteosarcoma and other solid tumors. Its lead asset, OST-HER2, has received rare pediatric disease designation and is expected to submit a biologics licensing application in 2025.

OS Therapies Inc. (NYSE American: OSTX), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, has announced its participation in several upcoming investor conferences. The company will be present at the Cantor Global Healthcare Conference 2025, the H.C. Wainwright 27th Annual Global Investment Conference, and the Lake Street Capital Markets 9th Annual Best Ideas Growth Conference.

OS Therapies is focused on the identification, development, and commercialization of treatments for osteosarcoma (OS) and other solid tumors. Its lead asset, OST-HER2, has received rare pediatric disease designation and is expected to submit a biologics licensing application (BLA) in 2025.

The company recently provided an update on its OST-HER2 recurrent, fully resected, pulmonary metastatic osteosarcoma program following a highly productive End of Phase 2 Meeting with the US Food & Drug Administration (FDA). OS Therapies remains on track to begin rolling submission of a BLA request to FDA for the program in September 2025 [1].

Key updates following the FDA End of Phase 2 Meeting include:
- No significant safety concerns with OST-HER2 in the targeted indication were identified.
- Chemistry, Manufacturing, and Controls (CMC) matters were agreed upon, with clear guidance on final steps needed for BLA approval.
- The company expects to have the necessary data ready for submission to FDA as part of the rolling BLA submission in Q4/2025.

OS Therapies continues to seek direction on which FDA guidance to rely upon for clinical efficacy for the pending BLA submission. The company has achieved statistically significant positive final 12-month Event Free Survival (EFS) data and interim 2-year overall survival data from its 40-patient Phase 2b trial [1].

The company is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology.

OS Therapies is committed to finding paths forward to bring new therapies forward for osteosarcoma given the continued high mortality rates in this rare pediatric cancer. The company expects significant progress to be made towards Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD), and Accelerated Approval or full approval at the October 10, 2025, FDA/OSI osteosarcoma workshop.

References:
[1] https://www.biospace.com/press-releases/os-therapies-provides-ost-her2-recurrent-fully-resected-pulmonary-metastatic-osteosarcoma-program-update-following-fda-end-of-phase-2-meeting