OS Therapies Incorporated
New York Stock Exchange ArcaCapital Structure
•
in mil. unless spec.Working Capital
•
in mil. unless spec.Growth Rates
•
in mil. unless spec.Quarterly Revenue
•
in mil. unless spec.Quarterly Earnings Per Share
•
in mil. unless spec.Quarterly Dividends Per Share
•
in mil. unless spec.Company Description
- CEO
- Paul A. Romness
- Full Time Employees
- 5
- Sector
- Healthcare
- Industry
- Biotechnology
- Address
- 115 Pullman Crossing Road Grasonville MD United States of America 21638
- IPO Date
- Aug 1, 2024
- CIK
- 0001795091
- Website
- ostherapies.com
- Similar Companies
- Business
- OS Therapies Incorporated (NYSE American: OSTX) is a clinical-stage biopharmaceutical company focused on the identification, development, and commercialization of innovative immunotherapies and targeted drug conjugates for osteosarcoma and other HER2-expressing solid tumors, including breast, colorectal, esophageal, lung, ovarian, and pancreatic cancers. The company's lead product candidate, OST-HER2, comprises an off-the-shelf, attenuated bioengineered Listeria monocytogenes-based immunotherapy that expresses HER2 peptides to activate T cells and stimulate the immune system against cancer cells and metastases; its pipeline also features OST-tADC (tunable antibody-drug conjugate), a plug-and-play platform utilizing pH-sensitive silicone dioxide linkers (SiLinkers) to deliver cell-penetrating payloads selectively into solid tumors via a bystander effect while minimizing toxicity to healthy tissue. Incorporated in 2018 and headquartered in Rockville, Maryland, OS Therapies operates primarily in the United States, conducting clinical trials at multiple sites across 18 states targeting pediatric and adult patients with rare and aggressive cancers that lack new FDA-approved treatments in over 40 years. In January 2025, the company agreed to acquire full rights to all Listeria monocytogenes-based immunotherapies from Ayala Pharmaceuticals, eliminating near-term milestone payments, reducing future royalty obligations on OST-HER2, and enhancing financial prospects ahead of planned regulatory submission; this followed a $7.1 million financing round in late 2024 at $4.00 per share, providing cash runway into 2026, and a September 2025 warrant exchange that raised approximately $3.7 million for commercialization efforts. OST-HER2 received U.S. FDA orphan drug, rare pediatric disease, and fast track designations, with Phase IIb trial enrollment ongoing as of late 2024 showing promising event-free and overall survival data in osteosarcoma.
Company News
OS Therapies Announces Initial Closing of Warrant Exercise Inducement and Exchange Offer for Initial Gross Proceeds of Approximately $7.2 Million
Rubenstein Public Relations Named Agency of Record for OS Therapies
OS Animal Health Receives USDA Feedback on Regulatory Pathway for OST-HER2 in Canine Osteosarcoma
OS Therapies Reports Significant Three-Year Survival Data for Bone Cancer Treatment
OS Therapies Achieves Statistically Significant Final Three-Year Overall Survival Benefit for Herlystic(TM)-Treated Patients in Phase 2b Pulmonary Metastatic Osteosarcoma Trial
OS Therapies Appoints Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer
OS Therapies Announces Brand Name 'Herlystic' Approved by World Health Organization for OST-HER2 (daznelimgene lisbac)
OS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis
OS Therapies Achieves Incremental Alignment With FDA and Accepts Project Orbis Invitation From MHRA on OST-HER2 Metastatic Osteosarcoma Program
OS Therapies Announces Full Alignment with UK MHRA and EU EMA for Conditional Marketing Authorisation Application Filing
OS Therapies Achieves Statistically Significant Benefit for OST-HER2-Treated Patients in Interim 3-Year Overall Survival Analysis of Phase 2b Pulmonary Metastatic Osteosarcoma Trial
OS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance
OS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates
OS Therapies Granted U.S. FDA Type C Statistical Methods Meeting to Review 2.5-Year Overall Survival Data for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma
OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program
OS Therapies Third Quarter 2026 Corporate Outlook
OS Therapies Appoints Dr. Craig Eagle to Board of Directors
OS Therapies Provides U.S. Regulatory Update
OS Animal Health Announces Peer-Reviewed Publication of Clinical Trial Data for OST-HER2 Plus Palliative Radiation as Frontline Treatment in Canine Osteosarcoma
OS Therapies Achieves Global Regulatory Alignment on Design of Phase 3 Trial of OST-HER2 in Fully Resected, Pulmonary Metastatic Osteosarcoma