OS Therapies Inc. (NYSE American: OSTX) announced its participation in the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference, scheduled for September 9-10 in New York City. During the conference, the company will engage with investors and strategic partners, with OS Animal Health also in attendance. This event comes at a crucial time as the company prepares for a series of regulatory and clinical milestones that could shape the future of its lead investigational therapy, OST-HER2.
OST-HER2 is an immunotherapy designed to treat fully resected pulmonary metastatic osteosarcoma, a rare bone cancer primarily affecting children and young adults. The therapy leverages the immune-stimulatory properties of listeria bacteria to target the HER2 protein, which is overexpressed in many tumors. The company expects to release interim three-year overall survival data in September, alongside key meetings with the U.S. Food and Drug Administration (FDA) and U.K. regulatory authorities. These discussions could lead to decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review, which are designed to expedite the development and review of promising therapies.
The significance of these upcoming events cannot be overstated. Positive data and regulatory advancements could position OST-HER2 as a potential first-in-class treatment for osteosarcoma, a disease with limited therapeutic options. 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 in the fourth quarter of 2026. If successful, OST-HER2 could address a significant unmet medical need, offering hope to patients who currently have few alternatives after surgical resection.
In addition to its human health applications, OS Therapies is also seeking USDA alignment on reinstating conditional approval for OST-HER2 in canine osteosarcoma. This veterinary indication not only expands the company's market potential but also provides valuable data that could inform human clinical development.
OS Therapies has already received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA, as well as similar designations from the European Medicines Agency. These regulatory recognitions underscore the potential of OST-HER2 and may provide incentives such as market exclusivity and priority review vouchers.
The company's participation in the Moody Capital conference is a strategic move to connect with the investment community at a pivotal moment. As regulatory decisions loom, investor interest is likely to intensify. The conference offers a platform for OS Therapies to communicate its progress and future plans, potentially influencing market perception and financial support.
For more information about OS Therapies, visit www.ostherapies.com. To view the full press release, visit https://ibn.fm/ERaOp.
