OS Therapies Inc. (NYSE American: OSTX) is set to participate in the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference on September 9-10 in New York City, where the company will engage with investors and strategic partners. The announcement comes at a pivotal time for the clinical-stage oncology company, as it prepares for a series of regulatory milestones for OST-HER2, its investigational immunotherapy for fully resected pulmonary metastatic osteosarcoma.
The company expects interim three-year overall survival data and key meetings with the U.S. Food and Drug Administration (FDA) and U.K. regulatory authorities in September. These meetings could lead to decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review, which would expedite the development and review of OST-HER2. Subsequently, the company targets final three-year data, a pre-BLA meeting with the FDA, and regulatory submissions in the U.S., U.K., and Europe in the fourth quarter of 2026.
OST-HER2 leverages a listeria-based platform to stimulate a robust immune response against the HER2 protein, which is overexpressed in many solid tumors. The therapy is designed to target three distinct epitopes of HER2, requiring only one to be present to trigger an immune response. This approach has garnered significant regulatory support, including Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA, as well as similar designations from the European Medicines Agency.
In addition to its human oncology pipeline, OS Therapies' subsidiary, OS Animal Health, is seeking alignment with the U.S. Department of Agriculture (USDA) to reinstate conditional approval for OST-HER2 in canine osteosarcoma. This veterinary application could provide additional validation of the platform's efficacy and safety, potentially accelerating the human development pathway.
The company's participation in the Moody Capital conference signals its proactive engagement with the investment community during a critical period. As OS Therapies advances its regulatory strategy, the outcomes of these meetings and data readouts will be closely watched by investors and the medical community alike, given the high unmet need in osteosarcoma, a rare bone cancer that primarily affects children and young adults.
According to the company, the upcoming months are expected to be transformative, with potential for significant progress in both human and animal health applications. The company's presence at the conference provides an opportunity for stakeholders to gain insights into its strategic direction and the potential impact of OST-HER2 on the treatment landscape for osteosarcoma.
For more information about OS Therapies and its pipeline, visit www.ostherapies.com.
