Welcome to our dedicated page for OS THERAPIES INCORPORATED news (Ticker: OSTX), a resource for investors and traders seeking the latest updates and insights on OS THERAPIES INCORPORATED stock.
OS Therapies Incorporated (NYSE American: OSTX) is a clinical-stage oncology and biopharmaceutical company focused on osteosarcoma and other solid tumors. News about OS Therapies centers on its listeria-based cancer immunotherapy programs, regulatory interactions, capital markets activity, and the planned spin-off of its veterinary oncology subsidiary, OS Animal Health.
A major theme in OSTX news flow is the progress of OST-HER2 (daznelene lisbac), the company’s lead listeria-based immunotherapy targeting the HER2 protein. Press releases highlight positive Phase 2b data in recurrent, fully resected, pulmonary metastatic osteosarcoma, including statistically significant benefit in 12-month event free survival and reported 2-year overall survival outcomes. The company also reports immune biomarker analyses from its human metastatic osteosarcoma trial and related canine osteosarcoma studies, emphasizing the role of Comparative Oncology and interferon gamma pathway biomarkers as potential surrogate markers of clinical efficacy.
Investors following OSTX news will see regular updates on regulatory milestones, such as FDA Type C and other meetings, waiver of the BLA application fee for OST-HER2, EMA Union Marketing Authorisation eligibility, and preparations for Biologics License Application and Marketing Authorisation Application submissions in the United States, United Kingdom, and European Union. Company outlook releases describe anticipated timelines for regulatory submissions, potential conditional approvals, and planned interactions with FDA, MHRA, and EMA.
OS Therapies also issues news on capital raising and corporate transactions, including warrant exercise inducement agreements, gross proceeds from warrant exercises, and the intended use of proceeds to fund OST-HER2 regulatory and commercial preparation activities and the proposed OS Animal Health spin-off. Additional news items cover the veterinary oncology strategy for canine osteosarcoma, recognition of OST-HER2 in documentaries and awards, and the development of the company’s tunable ADC (tADC) platform.
For readers tracking OSTX, this news feed provides a consolidated view of clinical trial updates, biomarker findings, regulatory developments, financing events, and the evolution of both the human and animal health franchises. Regular visits can help investors and observers monitor how OS Therapies advances OST-HER2 and its broader oncology pipeline through key clinical and regulatory inflection points.
OS Therapies (NYSE American: OSTX), a clinical-stage cancer immunotherapy and antibody drug conjugate biotech company, has announced its participation in three major investor conferences in September 2025. The company will attend the Cantor Global Healthcare Conference (Sept 3-5), the H.C. Wainwright Global Investment Conference (Sept 8-10), and the Lake Street Capital Markets BIG9 Conference (Sept 11).
Management will be available for meetings with institutional investors and brokers at all events, with a pre-recorded presentation available for H.C. Wainwright conference participants.
OS Therapies (NYSE:OSTX) has provided a significant update following its End of Phase 2 Meeting with the FDA regarding OST-HER2 for recurrent, fully resected, pulmonary metastatic osteosarcoma. The company plans to begin a rolling Biologics Licensing Application (BLA) submission in September 2025.
Key achievements include positive clinical data with statistically significant 12-month Event Free Survival (p=0.0197) and interim 2-year overall survival data (p=0.0046) from its 40-patient Phase 2b trial. The FDA identified no significant safety concerns and agreed on non-clinical and CMC-related matters. The company is awaiting FDA guidance on efficacy endpoints and statistical analysis plans that would support either Accelerated Approval or full marketing authorization.
A crucial FDA/OSI public meeting is scheduled for October 10, 2025, focusing on advancing osteosarcoma drug development pathways. The company is also developing the OST-400 database to potentially support a synthetic control arm for the trial.
OS Therapies (NYSE American: OSTX) has successfully completed a warrant exchange offer with holders of outstanding warrants originally issued in December 2024. The transaction raised $3.7 million in gross proceeds through the exercise of warrants with a $1.12 per share exercise price.
The new warrants issued have an exercise price of $3.00 per share with a forced exercise provision triggered when the stock trades above $9.00. The proceeds will primarily fund commercial preparations for OST-HER2, targeting prevention of recurrent pulmonary metastatic osteosarcoma. The company now has funding extended into 2027, with potential for additional $20 million if the forced exercise provision is triggered.
OS Therapies (NYSE American: OSTX), a clinical-stage biotechnology company focused on cancer immunotherapy and antibody drug conjugates, has announced plans to provide a comprehensive update following their End of Phase 2 Meeting with the FDA regarding OST-HER2. The update, scheduled for September 2, 2025, will detail the regulatory pathway for potential approval of OST-HER2 in treating recurrent, fully resected, pulmonary metastatic osteosarcoma.
The company described their August 27 meeting with the FDA as "highly constructive," suggesting positive developments in their clinical program for this rare cancer treatment.
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.