OS Therapies Inc

OSTX

Market cap $57M

FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support a Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documents FDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory study would have to be underway prior to granting a BLA FDA indicated that the use of canine data to support confirmation that pre-specified immune biomarker activation is correlated with treatment-emergent human clinical benefit will depend on biomarkers chosen for evaluation & clinical validation thereof FDA requested follow-up meeting once immune activation biomarker analysis is available to review data within context of pending Company-planned BLA filing Key Opinion Leader Dr. Peter Anderson, who participated in the meeting following FDA's request that a key opinion leader be present to help educate the agency on the standard of care in osteosarcoma, noted that immunotherapies such as OST-HER2 are the most promising treatment category being investigated Company anticipates immune activation biomarker analysis data will be released during week of the JP Morgan Healthcare Conference in January 2026 Company reiterates end of January 2026 timeline for planned BLA submission, with FDA-proposed meetings to review biomarker data & additional clinical data, as well as final confirmatory study design, expected to occur after BLA filing FDA feedback received remains in alignment with the Company's international regulatory strategy - including the United Kingdom and European Union New York, New York--(Newsfile Corp. - December 15, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it held a successful Type C meeting with the United States Food & Drug Administration (FDA) regarding the Phase 2b human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the 'Metastatic Osteosarcoma Program'). The Company made significant progress in understanding the parameters under which the agency would consider clinical efficacy data supported by treatment-emergent immune biomarker activation could be supportive of a BLA under the Accelerated Approval Program and reiterates its intent to file BLA documents with FDA by the end January 2026.

Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study design Biomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C Meeting Company reiterates end of January 2026 timeline for MAA submission New York, New York--(Newsfile Corp. - December 9, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it held a successful pre-Marketing Authorisation Application (MAA) with the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) regarding the Phase 2b human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the 'Metastatic Osteosarcoma Program'). The Company achieved full alignment with its pre-meeting objectives related to non-clinical, CMC (chemistry, manufacturing, and controls) and post-market authorization confirmatory study design.

U.S. FDA grants waiver of application fee for BLA Filing of OST-HER2 Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on December 8, 2025 Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025 New York, New York--(Newsfile Corp. - December 5, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced the United States Food & Drug Administration (FDA) granted the Company waiver of the application fee for BLA 125867 for OST-HER2. Additionally, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use ('CHMP') granted Union Marketing Authorisation eligibility for OST-HERs in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the 'Metastatic Osteosarcoma Program').

New 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 lisbac' for the non-proprietary name for the Company's HER2 targeted Listeria monocytogenes-based cancer immunotherapy product candidate OST-HER2. OST-HER2 is currently being developed for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.

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 metastatic osteosarcoma.

Type C Meeting with US FDA set for December 11, 2025 to address key items following August 27, 2025 End of Phase 2 Meeting regarding Phase 2b clinical trial of OST-HER2: prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma US Biologics Licensing Application (BLA) and UK MHRA Marketing Authorization Application filings for OST-HER2 expected in January 2025 leveraging Project Orbis UK MHRA pre-Marketing Authorization Application (MAA) meeting scheduled for December 8, 2025; EMA pre-MAA meeting request now granted, awaiting scheduling $7.8 million warrant exercise inducement allowed for key one-time regulatory-related payments and provided Company with capital into late 2026 by delaying launch to 2027 Company remains eligible to receive Priority Review Voucher (PRV) based on Pediatric Rare Pediatric Disease Designation (RPDD) for Osteosarcoma if approved by September 30, 2026 New York, New York--(Newsfile Corp. - November 17, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today reported third quarter 2025 financial results for the period ended September 30, 2025 and provided a business update. "The next six to twelve months will be transformative for OS Therapies," said Paul Romness, MPH, Chairman & CEO of OS Therapies.

New York, New York--(Newsfile Corp. - October 22, 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 additional overall and event free survival data generated from the Company's 41-patient Phase 2b clinical trial of its off-the-shelf immunotherapeutic candidate OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma (the "Phase 2b Osteosarcoma Trial"). The Company previously announced statistically significant positive final 2-year overall survival data from its Phase 2b Osteosarcoma Trial on October 10, 2025.

Final FDA Type C Meeting December 11, 2025 - biomarker data to be available October 10, 2025 FDA/Osteosarcoma Institute Workshop narrows focus for OST-HER2 overall survival, biomarker correlation & canine osteosarcoma data New York, New York--(Newsfile Corp. - October 17, 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 the United States Food & Drug Administration ("FDA") has granted a second Type C Meeting, following its successful End of Phase 2 Meeting. The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints to support a Biologics Licensing Application ("BLA") under the Accelerated Approval Program ("Accelerated Approval") for OST-HER2 following a successful Phase 2b clinical trial in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program").

75% 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 survival New York, New York--(Newsfile Corp. - October 10, 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 statistically significant positive final 2-year overall survival data from the Company's Phase 2b trial of off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the "Fully Resected Metastatic Osteosarcoma Trial"). 75% (27 out of 36 evaluable patients; 5 patients were lost to follow-up) of OST-HER2 treated patients achieved 2-year overall survival as measured from most recent pulmonary resection, compared with 40% of historical control patients1 (p < 0.0001) Subgroup analyses showed that 100% of patients who achieved 12-month Event Free Survival (EFS) achieved 2-year overall survival, whereas 59% of patients who did not achieve EFS achieved 2-year overall survival.

Overall survival recognized as key efficacy endpoint in osteosarcoma, where no standard of care exists Rapporteur highlights potential broader benefits of OST-HER2 in pulmonary and primary osteosarcoma settings, supported by translational canine data from the University of Pennsylvania New York, New York--(Newsfile Corp. - October 9, 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 a positive regulatory update following an October 6, 2025 meeting with its European Medicines Agency (EMA) rapporteur, the Dutch Medicines Evaluation Board (MEB). During the meeting, OS Therapies and the Dutch Rapporteur aligned on key areas, including safety, non-clinical and chemistry, manufacturing, and controls (CMC) data in support of the Company's ongoing OST-HER2 Phase 2b clinical trial in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma.