OS Therapies Receives Non-Proprietary Name 'daznelimgene lisbac' for OST-HER2 from World Health OrganizationNovember 25, 2025 9:21 AM EST | Source: OS TherapiesNew York, New York--(Newsfile Corp. - November 25, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved 'daznelimgene ...

Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (OSTX) 3Q25November 21, 2025 4:15 PM EST | Source: Reportable, Inc.Dallas, Texas--(Newsfile Corp. - November 21, 2025) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners updates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced key clinical, regulatory, and commercial milestones in 3Q25 as it moves closer to bringing OST-HER2 to patients with recurrent, fully resected, pulmonary m ...

Core Viewpoint - OS Therapies reported its third quarter 2025 financial results and highlighted significant upcoming regulatory milestones for its lead product, OST-HER2, which is aimed at treating osteosarcoma and other HER2-related cancers [3][4]. Financial Results - The company recorded a net operating loss of $6.879 million in Q3 2025, compared to a net operating loss of $2.875 million in Q3 2024, primarily due to pre-commercial activities related to the OST-HER2 program [6]. - Net loss per share was $0.21 on 31.956 million outstanding shares in Q3 2025, compared to a net loss of $0.18 per share on 15.897 million shares in Q3 2024 [6]. Regulatory Updates - A Type C meeting with the US FDA is scheduled for December 11, 2025, to discuss key items following the End of Phase 2 meeting regarding the OST-HER2 clinical trial [5][8]. - The company expects to file a Biologics Licensing Application (BLA) for OST-HER2 in January 2026, leveraging feedback from upcoming regulatory meetings [4][5]. - The UK MHRA pre-Marketing Authorization Application (MAA) meeting is set for December 8, 2025, in preparation for the January 2026 MAA filing [5][8]. Clinical Development - OST-HER2 has shown promising results in its Phase 2b trial, with a reported 2-year overall survival rate of 75% compared to a historical control of 40% (p < 0.0001) [8]. - The company anticipates that accelerated approval for OST-HER2 could catalyze further clinical development in osteosarcoma and other HER2-related cancers [4][6]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, which features tunable antibody-linker-payload candidates [10]. Future Outlook - The company expects to receive a Priority Review Voucher (PRV) if OST-HER2 is approved by September 30, 2026, which could be sold for additional revenue [5][9]. - Increased compassionate use requests have been noted, primarily from clinical sites involved in the Phase 2b trial, indicating growing interest and potential market demand for OST-HER2 [4].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-42195 OS THERAPIES INCOPORATED (Exact name of registrant as specified in its charter) (State or othe ...

Core Insights - OS Therapies announced additional overall and event-free survival data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma, highlighting statistically significant positive outcomes [2][4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset OST-HER2 being an immunotherapy that targets the HER2 protein [4][6] - OST-HER2 has received several designations from regulatory agencies, including Rare Pediatric Disease Designation and Fast-Track status from the U.S. FDA [4] Clinical Trial Results - The Phase 2b Osteosarcoma Trial involved 41 patients, with subgroup analyses revealing: - For patients with a lung-only second or greater metastatic event, the 2-year overall survival rate was 80.0% [5] - For patients with a lung-only first metastatic event, the 2-year overall survival rate was 73.8%, significantly higher than the 30% natural history comparator (p < 0.0001) [5] - The company anticipates submitting a Biologics License Application (BLA) to the U.S. FDA for OST-HER2 in 2025 [6] Future Plans - OS Therapies is preparing for regulatory meetings with the FDA, MHRA, and EMA to discuss overall survival data and trial design for OST-HER2 [3] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [7]

Core Insights - OS Therapies has received a second Type C Meeting from the FDA to discuss clinical efficacy data endpoints for OST-HER2, aimed at supporting a Biologics Licensing Application under the Accelerated Approval Program following a successful Phase 2b trial for metastatic osteosarcoma [1][2] - The UK MHRA has granted a pre-MAA Meeting for the same program, with the company planning to align BLA and MAA submission timelines as part of Project Orbis [2] - The company reported positive results from its Phase 2b clinical trial, demonstrating statistically significant benefits in the 12-month event-free survival primary endpoint [6] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset OST-HER2 being an immunotherapy targeting the HER2 protein [4][6] - OST-HER2 has received multiple designations from regulatory agencies, including Rare Pediatric Disease Designation and Fast-Track status from the FDA [4] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [7] Clinical Development and Regulatory Strategy - The FDA meeting is scheduled for December 11, 2025, allowing time for the company to gather biomarker data to correlate immune activation with clinical outcomes [1][5] - The recent FDA/Osteosarcoma Institute Workshop emphasized the importance of overall survival data as a key efficacy endpoint and discussed appropriate clinical trial designs for future immunotherapies [3][5] - The company anticipates submitting a BLA for OST-HER2 in 2025, which, if approved, would make it eligible for a Priority Review Voucher [6]

Core Insights - OS Therapies announced statistically significant positive final 2-year overall survival data from the Phase 2b trial of OST-HER2, showing 75% of treated patients achieved 2-year overall survival compared to 40% in historical controls [1][4] - The company is on track to file for conditional marketing authorization in the UK, the US, and the EU, with key regulatory meetings planned for December 2025 [3][6] Group 1: Clinical Trial Results - 75% of OST-HER2 treated patients achieved 2-year overall survival, significantly higher than the 40% in historical controls (p < 0.0001) [1][4] - Subgroup analysis indicated that 100% of patients who achieved 12-month Event Free Survival (EFS) also achieved 2-year overall survival [1][4] Group 2: Regulatory Path and Future Plans - The company plans to submit a conditional Marketing Authorization Application (MAA) to the MHRA in December 2025 and a Biologics Licensing Application (BLA) to the FDA in January 2026 [3][6] - OS Therapies is analyzing patient samples to confirm correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025 [3] Group 3: Company Overview and Product Pipeline - OS Therapies focuses on developing treatments for Osteosarcoma and other solid tumors, with OST-HER2 as its lead asset, which has received multiple designations from regulatory agencies [6][7] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [7]

Core Insights - OS Therapies received a positive regulatory update from the European Medicines Agency (EMA) following a meeting with the Dutch Medicines Evaluation Board (MEB) on October 6, 2025, regarding its OST-HER2 Phase 2b clinical trial for osteosarcoma [2][3] Regulatory Developments - The meeting aligned on key areas such as safety, non-clinical data, and chemistry, manufacturing, and controls (CMC) data, supporting the ongoing clinical trial [3][8] - The overall survival results from the trial, showing statistically significant final two-year data, may serve as a primary endpoint for conditional marketing authorization (CMA) [3][8] - A formal EMA Scientific Advice is anticipated in December 2025, establishing a potential pathway for a confirmatory randomized clinical development program [4][10] Clinical Trial Insights - The safety profile from the Fully Resected Osteosarcoma clinical study was confirmed as positive, with data from over 500 patients treated across four other therapeutic indications potentially supporting a CMA [8] - The rapporteur indicated that overall survival (OS) could provide a stronger measure of clinical benefit compared to 12-month Event-Free Survival (EFS) [8] - Efficacy data from other settings, such as recurrent, unresectable pulmonary metastatic osteosarcoma, could be incorporated into a post-market confirmatory clinical development program [8] Market Access and Future Plans - OS Therapies has commenced the Marketing Authorisation Application (MAA) submissions process with the UK MHRA, which has granted an expedited Market Access Scientific Advice Meeting [6] - The company plans to pursue a conditional marketing authorization while advancing a global randomized clinical study to evaluate OST-HER2 in various osteosarcoma clinical settings [10] - OST-HER2 has received multiple designations from the U.S. FDA and EMA, including Rare Pediatric Disease Designation and Fast-Track status [11]

Core Insights - OS Therapies is actively participating in multiple conferences and events in October 2025, showcasing its commitment to advancing cancer treatment and engaging with industry stakeholders [1][2][3][4][5]. Company Overview - OS Therapies Inc. is a clinical-stage biotechnology company focused on developing treatments for Osteosarcoma and other solid tumors, with its lead asset being OST-HER2, an immunotherapy targeting the HER2 protein [5][6]. - OST-HER2 has received several designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, indicating its potential significance in treating rare diseases [5]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, demonstrating statistically significant benefits in the 12-month event-free survival primary endpoint for patients with recurrent, fully resected, lung metastatic osteosarcoma [5]. Upcoming Events - OS Therapies will participate in the Cell and Gene Meeting on the Mesa from October 6-8, 2025, in Phoenix, AZ, focusing on partnering and one-on-one meetings [2]. - The company will also attend the Roth Annual Healthcare Opportunities Conference on October 9, 2025, in New York City, where it will engage in meetings with potential investors [2]. - A workshop on advancing osteosarcoma drug development will take place on October 10, 2025, in Washington, DC, where OS Therapies management will be available for discussions [2]. - The BIOFuture 2025 event is scheduled for October 13-15, 2025, in New York City, featuring a spotlight panel and one-on-one meetings [3]. - The company will be present at the 52nd Daytime Emmy Awards on October 17, 2025, where its documentary "Shelter Me: Cancer Pioneers" has received two nominations [3]. - The Maxim Growth Summit will occur on October 22, 2025, in New York City, where corporate presentations and meetings will be held [4]. - OS Therapies will also participate in BIO - Europe from November 3-5, 2025, in Vienna, Austria, focusing on partnering and meetings [5]. Product Development - OST-HER2 has shown preclinical efficacy in various models of breast cancer and has been conditionally approved by the U.S. Department of Agriculture for treating canines with osteosarcoma [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 Viewpoint - OS Therapies is advancing its regulatory submissions for OST-HER2, focusing on obtaining marketing authorizations in the UK and US for the treatment of pulmonary metastatic osteosarcoma, with submissions expected in late 2025 and early 2026 [3][7]. Regulatory Update - The company has updated its regulatory filing sequence to prioritize the UK MHRA conditional Marketing Authorisation Application (MAA) submission, which is expected to be completed in December 2025, followed by the US FDA Biologics Licensing Application (BLA) submission in January 2026 [3][7]. - A conditional MAA Pre-Submission Request has been submitted to the MHRA, and the company anticipates receiving formal acceptance for a rolling review request soon [4]. Clinical Trial Insights - The information in the MHRA conditional MAA submission aligns closely with the planned US FDA BLA submission, with the exception of the acceptable comparator arm for efficacy data [5]. - The company aims to use immune activation biomarker data as a surrogate marker correlated with overall survival to support its Accelerated Approval request [5][7]. Company Background - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with OST-HER2 being its lead asset [8]. - OST-HER2 has received several designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and has shown statistically significant benefits in its Phase 2b clinical trial [8]. Future Developments - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [9].