OS Therapies Inc. (NYSE: OSTX) has made significant progress in its clinical and regulatory programs during the third quarter of 2025, advancing its lead candidate OST-HER2 for recurrent, fully resected, pulmonary metastatic osteosarcoma. The company reported final 2-year overall survival (OS) data from its 41-patient Phase 2b trial, showing a 75% OS rate compared to 40% in historical controls, with 100% 2-year survival among patients who were event-free at 12 months.
Building on a successful End-of-Phase 2 interaction with the U.S. Food and Drug Administration (FDA), OS Therapies is preparing harmonized filings with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the FDA, with submissions expected around year-end. The company has secured a UK MHRA pre-MAA meeting and an FDA Type C meeting, both in the fourth quarter of 2025, supporting plans for a UK MAA submission and a U.S. Biologics License Application (BLA) filing in January 2026 under Project Orbis. Project Orbis is an FDA initiative that allows simultaneous submission and review of oncology products with international partners.
In parallel, OS Therapies announced its intent to spin off OS Animal Health (OSAH) into a separately financed, standalone public company in the first half of 2026. Existing OSTX shareholders are expected to receive direct equity participation in the new listing, which targets the substantial U.S. canine osteosarcoma market.
Financially, OS Therapies reported a net loss of $6.9 million for the third quarter of 2025, compared to $2.9 million in the same period last year, driven by increased regulatory and pre-commercial spending ahead of OST-HER2 filings. Cash and equivalents stood at approximately $1.9 million at quarter end, but subsequent proceeds from a warrant exercise and inducement exchange added about $7.8 million, extending the company's runway into late 2026. The company also terminated an equity line of credit and established an at-the-market program to provide additional financial flexibility.
Stonegate Capital Partners, which provides equity research coverage on OS Therapies, uses a probability-adjusted discounted cash flow model to value the company, yielding a valuation range of $5.59 to $7.58 per share, with a midpoint of $6.44. The firm notes that the valuation is highly dependent on long-term assumptions and could be subject to dramatic changes as new information becomes available.
For more details, see the full research report on Stonegate Capital Partners' website: https://stonegateinc.com/coverage/ostx/.
