OS Therapies to Present at Moody Capital Conference Amid Key Regulatory Milestones for OST-HER2

OS Therapies Inc. (NYSE American: OSTX), a clinical-stage oncology company specializing in immunotherapies for osteosarcoma and other solid tumors, announced its participation 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 OS Animal Health also attending. This conference arrives at a pivotal time for OS Therapies as it prepares for a series of regulatory interactions and data readouts that could define the near-term trajectory of its lead investigational therapy, OST-HER2.

OST-HER2 is designed to treat 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 the immune system against the HER2 protein, which is overexpressed in many tumors. The company has already secured Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration, as well as similar designations from the European Medicines Agency, including Advanced Therapy Medicinal Products classification.

September is expected to bring interim three-year overall survival data from the ongoing clinical program, along with key meetings with the FDA and U.K. regulatory authorities. These interactions could lead to decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review, both of which would expedite the development and review process. The company targets 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.

In parallel, OS Animal Health is seeking alignment with the U.S. Department of Agriculture to reinstate conditional approval for OST-HER2 in canine osteosarcoma, a move that could expand the therapy's reach and provide additional data supporting its efficacy.

The significance of these developments cannot be overstated. Osteosarcoma is the most common type of bone cancer, yet treatment options have remained limited for decades. Current standard of care involves surgery and chemotherapy, but outcomes for patients with metastatic disease are poor. OST-HER2's novel mechanism of action, which targets multiple epitopes of the HER2 oncogene, offers a potentially more precise and effective approach. If successful, it could fill an unmet medical need and become a new standard of care.

Investors and industry observers will be closely monitoring the upcoming data and regulatory milestones. Positive results could not only accelerate OST-HER2's path to market but also validate the broader listeria-based immunotherapy platform, which has implications for other solid tumors. The company's participation in the Moody Capital conference provides a forum to articulate these opportunities to the investment community.

For more information about OS Therapies, visit www.ostherapies.com.