OS Therapies Inc. (NYSE American: OSTX) is set to participate in the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference, scheduled for September 9-10 in New York City. The company will engage with investors and strategic partners, with a focus on its animal health division and the broader oncology pipeline. This appearance comes at a pivotal time as OS Therapies prepares for a series of regulatory and clinical milestones that could shape the future of its lead investigational therapy, OST-HER2.
OST-HER2 is designed for the treatment of fully resected pulmonary metastatic osteosarcoma, a rare and aggressive bone cancer primarily affecting children and young adults. The therapy leverages a gene-edited, listeria-based platform to stimulate a robust immune response against the HER2 protein, which is overexpressed in many tumors. By targeting multiple epitopes of HER2, OST-HER2 aims to trigger an immune attack on cancer cells and micro-metastases, potentially improving outcomes for patients with limited options.
The upcoming months are critical for the company. In September, OS Therapies expects interim three-year overall survival data from its clinical trials, along with 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 may expedite the development and review process. The company also anticipates that final three-year data, a U.S. Pre-BLA meeting, and regulatory submissions in the U.S., U.K., and Europe will occur in the fourth quarter of 2026.
Beyond its human oncology efforts, OS Therapies is advancing OST-HER2 for canine osteosarcoma through its OS Animal Health subsidiary. The company is seeking alignment with the U.S. Department of Agriculture (USDA) to reinstate conditional approval for the therapy in dogs, which could open a significant veterinary market and provide additional validation for the platform.
OST-HER2 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, including Advanced Therapy Medicinal Products classification. These designations underscore the unmet medical need and the potential of the therapy to address a serious condition.
The Moody Capital conference provides a platform for OS Therapies to communicate its progress and strategic direction to the investment community. With multiple regulatory and data milestones on the horizon, the company is positioned at a potentially transformative juncture. Positive outcomes could not only bring a novel therapy closer to patients but also establish OS Therapies as a leader in listeria-based cancer immunotherapy.
For more information, visit www.ostherapies.com.
