OS Therapies Inc. (NYSE American: OSTX), a clinical-stage oncology company specializing in immunotherapies for osteosarcoma and other solid tumors, is set to present at the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference in New York City on September 9-10. The company will also feature its subsidiary, OS Animal Health, during the event. This appearance arrives at a pivotal moment as OS Therapies approaches a series of regulatory and clinical milestones that could significantly impact its lead candidate, OST-HER2.
OST-HER2 is an investigational immunotherapy designed to treat fully resected pulmonary metastatic osteosarcoma, a rare and aggressive bone cancer primarily affecting children and young adults. The therapy leverages a live-attenuated Listeria monocytogenes vector to stimulate a robust immune response against tumors expressing HER2, a protein commonly overexpressed in various cancers. By targeting two extracellular and one intracellular epitope of HER2, OST-HER2 aims to trigger an immune attack even if only one of these epitopes is present in the tumor or micro-metastases, potentially offering a broad therapeutic window.
The company has already secured prestigious designations from regulatory bodies, including Orphan Drug Designation (ODD), Fast Track Designation (FTD), and Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA), as well as ODD, FTD, and Advanced Therapy Medicinal Products (ATMP) status from the European Medicines Agency (EMA). These designations underscore the unmet medical need and the potential of OST-HER2 to address a critical gap in osteosarcoma treatment.
In the coming months, OS Therapies expects to report interim three-year overall survival (OS) data from its pivotal trial, which could provide early evidence of the therapy's efficacy. Additionally, the company anticipates key meetings with the FDA and U.K. regulatory authorities in September, which may lead to decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review. A positive outcome could accelerate the development timeline. The company is targeting final three-year data, a U.S. Pre-BLA meeting, and regulatory submissions in the U.S., U.K., and Europe for the fourth quarter of 2026.
Simultaneously, OS Animal Health is seeking alignment with the U.S. Department of Agriculture (USDA) to reinstate conditional approval for OST-HER2 in canine osteosarcoma, a move that could expand the therapy's application and provide additional revenue streams. This dual-track approach highlights the versatility of the platform and the company's commitment to addressing osteosarcoma across species.
The upcoming conference provides a platform for OS Therapies to engage with investors and strategic partners at a time when regulatory clarity and clinical data are imminent. With the potential for breakthrough designations and accelerated approval pathways, OST-HER2 could become a first-in-class therapy for a disease that has seen limited progress in decades. The company's participation underscores its readiness to communicate its strategy and milestones to the investment community.
For more information about OS Therapies and its pipeline, visit www.ostherapies.com. To view the original press release, visit https://ibn.fm/ERaOp.
