OS THERAPIES INCORPORATED Stock Price, News & Analysis

OS Therapies (NYSE American: OSTX) has announced the termination of its Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund, LLC - Series 3, effective August 26, 2025. The company recently secured $4.2 million in gross proceeds through a warrant exercise inducement and exchange offering, providing operational funding through mid-2026.

The company has completed the treatment phases of two clinical trials: the Phase 2b OST-HER2 trial in osteosarcoma and the Phase 1b OST-504 trial in prostate cancer. With reduced projected monthly expenses in H2 2025, OS Therapies will focus on pursuing approval for OST-HER2 while evaluating development options for OST-504.

OS Therapies (NYSE American: OSTX) reported significant progress in Q2 2025 for its lead candidate OST-HER2 in treating osteosarcoma. The company announced statistically significant results from its Phase 2b trial, with 12-month Event Free Survival (35% vs. 20%, p = 0.0197) and interim 2-year Overall Survival (66.6% vs. 40%, p = 0.0046).

Key developments include FDA's confirmation of OST-HER2's RMAT biological qualification, BLA number issuance, and a scheduled End of Phase 2 Meeting for August 27, 2025. The company secured a $4.2 million capital raise extending runway into mid-2026 and partnered with Eversana for U.S. commercialization, targeting launch in H1 2026.

Financial results showed a Q2 2025 net operating loss of $4.537 million ($0.19 per share) compared to $1.557 million ($0.26 per share) in Q2 2024. The company aims to submit BLA in late Q3 2025 and could receive regulatory approval by year-end 2025.

OS Therapies (NYSE American: OSTX), a clinical-stage biotechnology company focused on cancer immunotherapy and antibody drug conjugates, has scheduled its second quarter 2025 financial results announcement for Tuesday, August 19, 2025. The company will present its financial performance for the period ended June 30, 2025, along with a business update.

OS Therapies (NYSE American: OSTX) reported significant positive interim results from its Phase 2b trial of OST-HER2 for osteosarcoma treatment. The study showed 66.6% (18 out of 27) of OST-HER2 treated patients achieved 2-year overall survival compared to 40% in the historical control group, with statistical significance (p = 0.0046).

The FDA has issued a Biologics Licensing Application (BLA) number for OST-HER2 ahead of the anticipated BLA filing following the August 27, 2025 End of Phase 2 Meeting. The company is working to align approval metrics for RMAT designation, Breakthrough Therapy designation, and BLA via the Accelerated Approval Program.

Additionally, OS Therapies has been included in the Russell Microcap, Russell Microcap Value, and Russell Microcap Growth indexes.

OS Therapies (NYSE American: OSTX) announced successful completion of a Scientific Advice Meeting with the UK's MHRA regarding OST-HER2, their immunotherapy treatment for recurrent, fully resected, pulmonary metastatic osteosarcoma. The company has submitted an Innovative Licensing and Access Pathway (ILAP) application to initiate the UK regulatory approval process.

MHRA recommended applying for Project Orbis to synchronize the UK Marketing Authorization Application with the FDA's Biologics Licensing Application Accelerated Approval Program. Additionally, the company secured a Scientific Advice Meeting with the Netherlands Medicines Evaluation Board for October 2025, advancing their EU-wide marketing authorization strategy via the Centralised Procedure.

OS Therapies (NYSE American: OSTX) has successfully closed a warrant exercise inducement and exchange offer, raising $4.2 million in gross proceeds. The funding extends the company's cash runway through 2026, beyond the September 2026 sunset date for the rare pediatric priority review voucher (PRV) program.

The proceeds will support regulatory efforts for OST-HER2 in treating pulmonary metastatic osteosarcoma, advance strategic alternatives for OS Animal Health subsidiary, complete the OST-504 prostate cancer study, and initiate AI-driven next-gen tADC product candidate modeling. The company plans to pursue a Biologics Licensing Authorization under the Accelerated Approval Program for OST-HER2 in human osteosarcoma within the next 18 months.

OS Therapies (NYSE American: OSTX) announced significant regulatory progress for its oncology programs. The company has scheduled an End of Phase 2 Meeting with FDA on August 27, 2025 to review its OST-HER2 program for recurrent, pulmonary metastatic osteosarcoma, aiming to begin a rolling BLA submission under Accelerated Approval.

The company has secured Scientific Advice Meetings with European regulators, including EMA and MHRA, pursuing marketing authorizations across Europe and the UK. Additionally, all patients in the Phase 1 clinical study of OST-504 for second-line prostate cancer have completed treatment, with data expected in H2 2025.

OS Therapies aims to obtain regulatory approval for OST-HER2 before the rare pediatric disease priority review voucher (PRV) program expires, planning to use potential PRV sale proceeds for commercialization and pipeline advancement.

OS Therapies (NYSE-A: OSTX) has achieved a significant milestone as the FDA granted an End of Phase 2 Meeting for its OST-HER2 program, targeting the prevention of recurrent, fully resected, pulmonary metastatic osteosarcoma. The meeting is scheduled for Q3 2025.

The company plans to pursue a Rolling Review process for its Biologics Licensing Application (BLA), potentially expediting the approval timeline. OST-HER2 has secured multiple FDA designations including Orphan Disease, Fast Track, and Rare Pediatric Disease Designation. If granted Accelerated Approval before September 30, 2026, OSTX could receive a Priority Review Voucher, with recent vouchers valued at $160 million.

OST-HER2 is an immunotherapy using HER2-bioengineered Listeria monocytogenes to target HER2-expressing cancer cells, with ongoing development in both human and canine applications.

OS Therapies (NYSE-A: OSTX) announced statistically significant positive clinical data for its immunotherapy candidate OST-HER2 in treating osteosarcoma. The Phase 2b trial showed that 35% of OST-HER2-treated patients achieved 1-year event free survival (EFS) compared to 20% in the historical control group (p=0.0194).

The safety profile demonstrated that 13 out of 40 patients experienced severe adverse events (SAEs), with only 7 patients having treatment-associated adverse events (TSAEs), all grade 3, with no grade 4 or 5 events reported. Notably, no patients discontinued the study due to adverse events.

The company is pursuing FDA Accelerated Approval and has submitted additional external control data following a Type D Meeting. OST-HER2 holds multiple FDA designations including Orphan Disease Designation, Fast Track, and Rare Pediatric Disease Designation. The UK's MHRA has agreed to support the company with data from its Clinical Practice Research Datalink to assist in potential worldwide marketing authorizations.