Overview

OS Therapies is a clinical stage biopharmaceutical company focused on developing treatments for osteosarcoma (OS) and other solid tumors. The company’s mission is to address the significant need for new treatments in cancers of the bone, particularly in children and young adults.

Recent Developments

PIPE Financing

• In December 2024, OS Therapies raised $7.1 million through a private placement (PIPE) financing, issuing 1.8 million shares of Series A preferred stock and warrants.
• The PIPE financing was subject to stockholder approval, which was obtained at a special meeting in April 2025.

Acquisition of HER2 and Lm-Related Assets

• In April 2025, OS Therapies acquired HER2-related immune-oncology programs and intellectual property assets from Ayala Pharmaceuticals for $8 million.
• This included two investigational new drug (IND) filings with the FDA for ADXS-503 in non-small cell lung cancer and ADXS-504 in prostate cancer.

Financial Performance

Three Months Ended March 31, 2025 vs. March 31, 2024

• Research and development expenses increased from $0.4 million to $1.3 million, primarily due to increased costs for the Phase IIb clinical trial of OST-HER2.
• General and administrative expenses increased from $0.3 million to $3.7 million, mainly due to marketing and advisory fees related to the PIPE financing.
• Net loss increased from $1.5 million to $3.9 million.

Liquidity and Capital Resources

• As of March 31, 2025, OS Therapies had $3.0 million in cash, down from $5.5 million at the end of 2024.
• The company believes the net proceeds from the PIPE financing and IPO will fund operations for the next 9-12 months.
• OS Therapies has funded operations to date primarily through the sale of convertible notes, Series A securities, and common stock in its IPO, raising a total of $34.6 million.

Outlook

• OS Therapies plans to request a meeting with the FDA in Q2 2025 to discuss the Phase IIb data for OST-HER2 and the path to a Biologics License Application (BLA) submission.
• Subject to positive FDA feedback, the company intends to submit a BLA shortly thereafter for approval to market OST-HER2 in osteosarcoma.
• Upon regulatory approval, OS Therapies also plans to evaluate OST-HER2’s potential use in other solid tumors, both alone and in combination with HER2-targeting antibodies.

In summary, OS Therapies is a clinical-stage biopharmaceutical company focused on developing novel treatments for osteosarcoma and other solid tumors. The company recently raised capital through a PIPE financing, acquired additional assets, and is advancing its lead candidate OST-HER2 through late-stage clinical development. OS Therapies is working towards potential regulatory approval and commercialization of OST-HER2 in osteosarcoma, while also exploring expansion into other solid tumor indications.