Core Viewpoint - OS Therapies Inc. has launched a warrant exercise inducement and exchange offer to nine accredited investors, raising a total of $7.53 million in gross proceeds to support its ongoing projects and regulatory filings [1][3]. Group 1: Financial Details - The gross proceeds of $7.53 million will provide the company with a financial runway into 2027 [3]. - All nine investors who were offered the inducement have agreed to participate in the exercise of their existing warrants [7]. Group 2: Regulatory and Development Plans - The company plans to use the net proceeds to support regulatory filings and commercial preparation activities for its lead asset, OST-HER2, aimed at treating pulmonary metastatic osteosarcoma [3]. - OS Therapies intends to file a Biologics Licensing Application (BLA) with the U.S. FDA by the end of January 2026 and expects to submit Marketing Authorisation Applications (MAA) to the UK and EU regulatory bodies by February and March 2026, respectively [4][5]. - The company is hopeful for regulatory approval for OST-HER2 in the UK by Q2 2026, in the U.S. by Q3 2026, and in Europe by Q4 2026 [4]. Group 3: Product Designations and Market Potential - OST-HER2 has received Orphan Disease Designation and Fast Track Designation from the FDA, as well as Rare Pediatric Disease Designation, which may allow the company to receive a Priority Review Voucher (PRV) if it gains Accelerated Approval before September 30, 2026 [5]. - The most recent PRV sale was valued at $160 million, indicating significant market potential for the company if it successfully monetizes a future PRV [5]. Group 4: Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leveraging listeria-based cancer immunotherapies [9]. - The company reported positive data from its Phase 2b clinical trial of OST-HER2, demonstrating significant benefits in the primary endpoint of 12-month event-free survival [9].