OS Therapies Incorporated(OSTX) - 2025 Q2 - Quarterly Results

OS Therapies Q2 2025 Financial Results and Business Update Business Update and Strategic Outlook The company reports positive clinical data and regulatory progress for its lead candidate OST-HER2, advancing towards a BLA submission and a potential 2026 launch - Updated interim 2-year overall survival and final 12-month Event Free Survival (EFS) data both show a statistically significant benefit for patients treated with OST-HER2[3] - The company is progressing towards a Biologics Licensing Application (BLA) submission to the U.S. FDA for OST-HER2 under the Accelerated Approval Program[3] - A commercial partnership with Eversana is in place, preparing for a potential U.S. launch of OST-HER2 in the first half of 2026[3] - The company is eligible for a Priority Review Voucher (PRV) upon BLA approval, which it intends to sell; recent PRV sales were valued between $155 million and $160 million[3] - Regulatory processes have been initiated internationally, with an ILAP submission to the U.K's MHRA and a scheduled meeting with the European Medicines Agency (EMA)[3] Key Corporate Highlights The company highlights positive FDA interactions, strong clinical data, a commercial partnership, a successful capital raise, and inclusion in Russell indexes - The FDA confirmed OST-HER2 meets the biological definition of a Regenerative Medicine Advanced Therapy (RMAT) and issued a BLA number in preparation for submission[4] - Statistically significant 12-month Event Free Survival and interim 2-year Overall Survival data are driving global accelerated approval pathways[4] - A commercial partnership with Eversana positions OST-HER2 for a potential U.S. launch in the first half of 2026[4] - A $4.2 million capital raise, closed in July 2025, extends the company's cash runway into mid-2026[4] - The company's stock (OSTX) was included in the Russell Microcap, Russell Microcap Value, and Russell Microcap Growth indexes[4] Detailed Progress and Upcoming Milestones The company outlines significant clinical, regulatory, and corporate achievements and key milestones for the remainder of 2025 Progress to Date The company details positive clinical data, regulatory progress in the US and Europe, and key corporate developments including a capital raise and partnership OST-HER2 Phase 2b Clinical Trial Data | Metric | OST-HER2 vs. Control | P-value | | :--- | :--- | :--- | | Final 12-month EFS | 35% vs. 20% | p = 0.0197 | | Interim 2-year Overall Survival | 66.6% vs. 40% | p = 0.0046 | - OST-HER2 demonstrated a strong safety profile, with zero patients experiencing grade 4 or grade 5 treatment-associated adverse events[5] - Acquired the listeria cancer immunotherapy platform from Ayala Pharmaceuticals, adding 4 clinical-stage and 8 preclinical-stage candidates to the pipeline[5] - Closed a warrant exercise inducement and exchange offering, raising $4.2 million in gross proceeds and extending the cash runway into mid-2026[5] Upcoming 2025 Milestones Key upcoming milestones include FDA and EMA meetings and the initiation of a rolling BLA submission for OST-HER2 - An End of Phase 2 Meeting with the FDA is scheduled for August 27, 2025, to guide the BLA submission process[9] - The company projects initiating a rolling BLA submission for OST-HER2 in late Q3 2025[9] - A rapporteur meeting with the EMA is scheduled for October 2025 to advance the European approval process[9] - The company is targeting potential regulatory approval for OST-HER2 in the U.S. and U.K. as early as year-end 2025[9] - An At-The-Market (ATM) offering agreement was established, enabling the company to raise up to $18 million in gross proceeds[9] Second Quarter 2025 Financial Results The company reports a higher net operating loss due to increased regulatory expenses, though net loss per share improved with more shares outstanding Q2 2025 vs. Q2 2024 Financials | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Operating Loss | $4.537 million | $1.557 million | | Net Loss Per Share | $0.19 | $0.26 | | Weighted Avg. Shares | 25.114 million | 5.991 million | - The increase in net operating loss was largely due to expenses associated with U.S. and international regulatory activities for the OST-HER2 Phase 2b osteosarcoma program[6] Company Overview The company is a clinical-stage oncology firm focused on Osteosarcoma, with a lead immunotherapy candidate, OST-HER2, and a tADC platform - The company's lead asset is OST-HER2, an immunotherapy for Osteosarcoma that targets the HER2 protein[7] - OST-HER2 has received Rare Pediatric Disease Designation (RPDD), Fast-Track, and Orphan Drug designations from the U.S. FDA and EMA[7] - The company is also advancing a next-generation tunable Antibody Drug Conjugate (tADC) platform using proprietary Si-Linker and Conditionally Active Payload (CAP) technology[8]