OS Therapies Inc

OSTX

Market cap $44.7M

New York, New York--(Newsfile Corp. - February 4, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, is honored to celebrate the passage of the Mikaela Naylon Give Kids A Chance Act. Mikaela, like so many other children, courageously battled pediatric cancer - specifically Osteosarcoma.

Request for FDA Rolling Review submitted to FDA on January 30, 2026 Non-Clinical and CMC BLA modules submitted to FDA At FDA's request, Type D Meeting expected in March 2026 to review Comparative Oncology biomarker data from patients treated in OST-HER2 Phase 2b human clinical trial and OST-HER2 trial in spontaneous osteosarcoma in canines Final BLA clinical module expected to be submitted to FDA by end of March 2026 after Type D Meeting Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker data Company remains on track to be eligible to receive Priority Review Voucher under Rare Pediatric Disease Designation (RPDD) with approval anticipated by September 30, 2026 New York, New York--(Newsfile Corp. - February 2, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it has formally initiated a Biologics License Application (BLA) submission to the U.S. Food & Drug Administration (FDA) for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma ("Human Metastatic Osteosarcoma"). The Company has submitted the Non-Clinical and the Chemistry, Manufacturing, and Controls (CMC) modules of the BLA to FDA, along with a request for Rolling Review.

OS Therapies Incorporated (NYSE: OSTX) shares are down on Thursday following the announcement of positive biomarker data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, a type of bone cancer.

Activation of immune blood biomarkers from interferon gamma pathway distinguished long term survivors (>=2 years) from short-term survivors (=2 years) from short-term survivors (

OS Animal Health (OSAH), a wholly-owned subsidiary of OS Therapies (OSTX), targeting Initial Public Offering (IPO) on NYSE American or Nasdaq Capital Markets national stock exchange in the first half of 2026 (1H/2026) OSTX shareholders expected to receive one (1) share of OSAH for every ten (10) shares of OSTX owned as of the expected to-be-determined 1H/2026 record date OSAH to focus primarily on the re-establishment of USDA conditional approval and commercialization of immunotherapy OST-HER2 for canine osteosarcoma and other HER2 positive cancers in animals OST-HER2 featured in 2025 2x Emmy-nominated and Anthem Award-winning documentary 'Shelter Me: Cancer Pioneers' streaming on PBS OSTX reiterates release date of January 15, 2026 for biomarker data from Phase 2b OST-HER2 trial in human pulmonary metastatic osteosarcoma that will be used to support upcoming Biologics License Application submission with US FDA New York, New York--(Newsfile Corp. - January 14, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that its wholly-owned subsidiary OS Animal Health Corp (OSAH) has filed a Form S-1 with the Securities Exchange Commission (SEC) in preparation for an Initial Public Offering (IPO). OSAH intends to list on either the NYSE American or Nasdaq Capital Markets national stock exchange in the first half of 2026 (1H/2026).

$7.53M gross proceeds raised from pre-existing investors, providing capital runway into 2027 All nine investors that were offered agreed to participate Net proceeds to fund OST-HER2 regulatory approval submissions, commercial preparation activities and preparations for OS Animal Health proposed spinoff transaction New York, New York--(Newsfile Corp. - January 12, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in listeria-based cancer immunotherapies, today announced that it launched a warrant exercise inducement and exchange offer to nine accredited investors (the "Holders") that hold common stock purchase warrants issued in connection with the Company's previous third quarter 2025 warrant exercise inducement and exchange offers (the "Existing Warrants"). All nine Holders offered have entered into inducement offer letter agreements with the Company to exercise or pre-fund for cash all of their Existing Warrants, providing a total of $7.53 million in gross proceeds to the Company.

NEW YORK, Jan. 5, 2026 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating OS Therapies Incorporated (NYSE American: OSTX) on behalf of the company's shareholders. The investigation seeks to determine whether OS Therapies's directors breached their fiduciary duties in connection with recent corporate actions.

Company finalizing preparations for end of January 2026 U.S. FDA Biologics License Application (BLA) submission for OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Metastatic Osteosarcoma Program) under Accelerated Approval Program Biomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026 UK and EU Marketing Authorisation Application (MAA) submissions for conditional approval expected by end of February 2026 and March 2026, respectively Company expects to participate in multiple H1 2026 meetings with U.S. FDA, U.K. MHRA and Europe's EMA as part of processes to gain regulatory approvals OS Animal Health 'go-public' transaction SEC filing expected in early January 2026 Delayed data from OST-504 Phase 1 trial in castration resistant prostate cancer expected in Q1 2026 after prioritizing biomarker lab partner resources for osteosarcoma data analysis, with End of Phase 1 FDA meeting expected in Q2 2026 Company plans to request End of Phase 2 meeting with FDA to review OST-503 non-small cell lung cancer frontline trial results in combination with Keytruda® New York, New York--(Newsfile Corp. - January 5, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided stakeholders with a corporate outlook for the first half 2026.

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.