OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic OsteosarcomaOctober 10, 2025 6:00 AM EDT | Source: OS Therapies75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001)100% of patients who achieved 12 month event free survival achieved 2 year overall survivalNew York, New ...

OS Therapies Provides Positive EMA Regulatory Update Following Positive Rapporteur MeetingOctober 09, 2025 7:40 AM EDT | Source: OS TherapiesOverall survival recognized as key efficacy endpoint in osteosarcoma, where no standard of care existsRapporteur highlights potential broader benefits of OST-HER2 in pulmonary and primary osteosarcoma settings, supported by translational canine data from the University of PennsylvaniaNew York, New York--(Newsfile Corp. - October 9, 2025) - OS Therapies In ...

OS Therapies to Participate in Fall 2025 Conferences and EventsOctober 07, 2025 11:50 AM EDT | Source: OS TherapiesDaytime Emmy Awards participation - 2 nomination for 'Shelter Me: Cancer Pioneers' Comparative Oncology documentary that features clinicians, veterinarians and human & canine patients who participated in OST-HER2 clinical trialsNew York, New York--(Newsfile Corp. - October 7, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer ...

OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory UpdateSeptember 30, 2025 7:40 AM EDT | Source: OS TherapiesCompany updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting feedback from UK MHRAIn principle, UK MHRA accepts use of historical control arm to support conditional MAAUK MHRA conditional MAA and US FDA Biologics Licensing ...

OS Therapies to Participate in Spotlight Panel at BioFuture 2025 October 13 11:00am EDTSeptember 19, 2025 7:40 AM EDT | Source: OS TherapiesNew York, New York--(Newsfile Corp. - September 19, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it has been invited to participate in the "Beyond the Cure: The Brave New World of Revolutionary Cancer Therapeut ...

Core Insights - OS Therapies has completed the last patient visit in its Phase 1b clinical trial for OST-504, focusing on biochemically recurrent prostate cancer, with a total of 7 patients enrolled [1][2] - The company is optimistic about the potential of OST-504 in various prostate cancer settings and plans to report study results in Q4 2025 [2] - Prostate cancer represents a significant market opportunity, with 1 in 8 men diagnosed and 1 in 44 men dying from the disease, making it the second leading cause of cancer death among men [2] - The company is also preparing for a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in osteosarcoma, which could lead to accelerated market access for OST-504 if successful [2][5] - Updated 2-year overall survival data from the Phase 2b trial of OST-HER2 will be released on October 10, 2025 [4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [3][5] - OST-HER2 has received multiple designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status, and has shown positive results in its Phase 2b clinical trial [3][5] - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6]

Core Insights - Stonegate Capital Partners has initiated coverage on OS Therapies Inc. (OSTX), highlighting significant clinical, regulatory, and financial advancements in Q2 2025 as the company approaches the launch of OST-HER2 for patients with recurrent, fully resected, pulmonary metastatic osteosarcoma [1][3] Clinical and Regulatory Developments - The FDA has confirmed that OST-HER2 qualifies as a Regenerative Medicine Advanced Therapy (RMAT) and has issued a Biologics License Application (BLA) number in preparation for an Accelerated Approval submission [1][3] - Final 12-month Event Free Survival (EFS) results from the Phase 2b trial showed a statistically significant improvement of 35% compared to 20%, alongside interim 2-year Overall Survival (OS) data of 66.6% versus 40%, indicating strong clinical benefits [5] Financial Position and Partnerships - OS Therapies has secured a U.S. commercial partnership with Eversana, positioning for a potential U.S. launch in the first half of 2026 [1][3] - The company completed warrant exchange financings raising approximately $7.9 million in Q3, extending its cash runway into 2027 and funding preparations for the commercial launch [5]

Core Insights - OS Therapies Inc. is a clinical-stage biotechnology company focused on cancer immunotherapy and antibody drug conjugates, particularly for Osteosarcoma and other solid tumors [1][2] - The company's lead asset, OST-HER2, has shown positive results in a Phase 2b clinical trial for recurrent lung metastatic osteosarcoma, achieving statistically significant benefits in the 12-month event-free survival primary endpoint [1] - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, and the company plans to submit a Biologics Licensing Application in 2025 [1] - The company is also developing a next-generation Antibody Drug Conjugate platform known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [2] Upcoming Events - OS Therapies will participate in several investor conferences in September 2025, including the Cantor Global Healthcare Conference from September 3-5, H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, and Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11 [5]

Core Viewpoint - OS Therapies is progressing towards the submission of a rolling Biologics Licensing Application (BLA) for its OST-HER2 program targeting recurrent, fully resected, pulmonary metastatic osteosarcoma, following a productive End of Phase 2 meeting with the FDA [1][2][6] Group 1: FDA Meeting Outcomes - The FDA and OS Therapies reached alignment on several critical areas necessary for a successful BLA, including clinical trial efficacy endpoints and statistical analysis plans [2] - A public meeting with key osteosarcoma stakeholders is scheduled for October 10, 2025, to discuss advancing drug development for osteosarcoma [2] - The FDA is committed to working closely with the Company, prioritizing both formal and informal meetings, with the first informal meeting set for mid-September 2025 [2][6] Group 2: Clinical Data and Safety Profile - No significant safety concerns were identified for OST-HER2 based on the clinical data available to date, indicating an excellent safety profile [3] - The Company is preparing necessary data for submission to the FDA as part of the rolling BLA submission expected in Q4 2025 [3] Group 3: Designations and Financial Aspects - OST-HER2 has received Rare Pediatric Disease Designation (RPDD) and is eligible for a Prescription Drug User Fee Act (PDUFA) small business fee waiver, with a decision expected by the end of Q3 2025 [5][7] - The Company anticipates significant progress towards Breakthrough Therapy designation (BTD) and either Accelerated Approval or full approval during the upcoming FDA/OSI workshop [4] Group 4: Future Developments - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [8] - The Company is actively compiling data for the OST-400 natural history database to support the development of a synthetic control arm for future trials [2][6]

Core Insights - OS Therapies has completed a warrant inducement and exchange offer, raising approximately $3.7 million in gross proceeds to accelerate preparations for the commercial launch of OST-HER2 [1][4] - The company aims to bring OST-HER2 to market in early 2026, pending FDA regulatory approval [2] - New warrants have been issued with an exercise price of $3.00 per share, which includes a forced exercise provision when the stock trades above $9.00, potentially bringing in over $20 million in additional funding [2][4] Financial Details - The warrant exchange raised approximately $3.7 million, which will primarily be used for commercial preparations related to OST-HER2 [1][4] - The forced exercise provision of the new warrants could lead to over $20 million in additional funding if triggered [2] Product Development - OST-HER2 is the lead asset of OS Therapies, targeting osteosarcoma and has received multiple designations from the FDA, including Rare Pediatric Disease Designation [3][5] - The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025, which could lead to a Priority Review Voucher if approved [5] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) technology, known as tunable ADC (tADC) [6]