OS Therapies Provides Corporate Update

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today provided a corporate update to the marketplace to contextualize recent positive clinical data, corporate and financial developments.

“January 2025 was the most significant month in the Company’s history,” said Paul Romness, MHP, Chairman & CEO of OS Therapies. “We started OS Therapies because someone very close to my family developed osteosarcoma and we realized that if first line therapy failed, the metastasis that could follow had very poor long-term prognosis. The data we generated in our Phase 2b trial with OST-HER2 provides the first glimmer of hope in over 40 years that a paradigm shift could radically change the course of this deadly disease. We intend to stay laser focused on our mission of bringing this therapy to market so that when the next family that gets the devastating news of an osteosarcoma diagnosis, they’ll know that treatment options might exist in the event that chemotherapy and resection/amputation fail to prevent metastasis, which is the case in approximately 50% of patients.”

Cash position and burn rate

On January 14, 2025, the Company disclosed that it completed a $7.1 million financing round (the “Preferred Round”) designed to fund the Company through a Biologics Licensing Authorization (BLA) decision from the US Food & Drug Administration (“FDA”) regarding the OST-HER2 program in the prevention of metastases in osteosarcoma. This was in addition to the $6 million initial public offering the Company completed in August 2024. Taken together, this $13.1 million that the Company raised over the last 6 months provides sufficient capital to fund:

• Final payments for the OST-HER2 osteosarcoma trial (inclusive of any expected non-clinical work required by FDA).
• Commercial manufacturing required for FDA approval and product launch.
• Strategic & operational costs related to FDA & EMEA correspondence, meetings, and regulatory submissions.
• Commercial launch preparations.
• Acquisition of the Listeria monocytogenes (“Listeria”) platform from Ayala.
• Corporate overhead.

Under the terms of the Preferred Round, the Company is precluded from raising additional capital for 6 months, in addition to being precluded from selling shares under its Equity Line of Credit (“ELOC”) so long as the price of the common stock is below $12.00. Additionally, the warrants issued in connection with the Preferred Round have certain forced exercise provisions when the common stock trades above $12.00.