OS Therapies Inc (NASDAQ: OSTX) is a clinical-stage biopharmaceutical company developing immunotherapy treatments targeting osteosarcoma, a bone cancer that affects primarily pediatric patients. The company has no approved products and generates no product revenue, funding operations through equity issuances and warrant exercises rather than commercial sales. Its lead program, OST-HER2, is a HER2-targeting immunotherapy derived from a Listeria-based platform, originally licensed from Advaxis and subsequently acquired by OS Therapies for further development. OST-HER2 has been evaluated in a preclinical canine study of HER2-positive appendicular osteosarcoma, with results published in Clinical Cancer Research in 2016 showing improvements in overall survival relative to a historical control cohort. The company relies on third-party contract research organizations and a limited number of sole-source API suppliers for clinical development. The U.S. incidence of osteosarcoma is approximately 1,000 new cases annually, with approximately 20,000 cases globally, per the FY2025 10-K filed 2026-03-31.

Revenue model

No product revenue as of the 10-K filed 2026-03-31. Operations are funded through equity offerings and cash warrant exercises, including multiple inducement offerings to existing warrant holders.

Products and services

OST-HER2: a HER2-targeting, Listeria-based immunotherapy in development for osteosarcoma, acquired from Advaxis. No products have received marketing approval.

Customers and end markets

End market is pediatric and adolescent osteosarcoma patients. No commercial customers as of the 10-K filed 2026-03-31. Prescribers, if any future product is approved, would be oncologists and healthcare providers subject to U.S. federal anti-kickback and False Claims Act regulations.

Value-chain role

Clinical-stage drug developer. Outsources clinical trial execution to third-party CROs and sources active pharmaceutical ingredient from a small number of suppliers, including sole-source suppliers.

Geographic exposure

Development activities centered in the United States. The 10-K filed 2026-03-31 notes that ability to generate revenue outside the United States may be limited by pricing controls, reimbursement restrictions, and market access barriers, particularly in the European Union.

Source: SEC 10-K, filed 2026-03-31

Industry: Pharmaceutical Preparations