Core Viewpoint - Purcell & Lefkowitz LLP is investigating OS Therapies Incorporated to determine if the company's directors breached their fiduciary duties related to recent corporate actions [1]. Group 1 - The investigation is being conducted on behalf of OS Therapies's shareholders [1]. - The law firm specializes in representing shareholders who are victims of securities fraud and breaches of fiduciary duty [3]. - Shareholders interested in their rights and options can contact the firm for more information [2].

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 ProgramBiomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026UK and EU Marketing Authorisation Application (MAA) submissi ...

Core Viewpoint - OS Therapies Inc. has made significant progress in discussions with the FDA regarding the Phase 2b clinical trial of its lead product candidate, OST-HER2, for the treatment of recurrent pulmonary metastatic osteosarcoma, with plans to submit a Biologics Licensing Application (BLA) by the end of January 2026 [1][2][7]. Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leading in listeria-based cancer immunotherapies [4]. - OST-HER2 is an innovative immunotherapy that utilizes a bioengineered form of Listeria monocytogenes to elicit a strong immune response against cancer cells expressing HER2 [2][4]. FDA Meeting Highlights - The FDA confirmed that data from single-arm studies in ultra-rare pediatric cancer osteosarcoma could support a BLA under the Accelerated Approval Program [7][8]. - The FDA suggested a confirmatory study design that includes additional osteosarcoma disease settings, such as the prevention of recurrence following primary tumor resection [7][8]. - The FDA indicated that the use of canine data to support the correlation between immune biomarker activation and clinical benefit will depend on the chosen biomarkers and their clinical validation [7][8]. Upcoming Milestones - The company expects to complete the immune activation biomarker analysis soon, with data to be released during the JP Morgan Healthcare Conference in January 2026 [2][3]. - Following the BLA submission, the company plans to hold additional meetings with the FDA to review biomarker data and confirmatory study design [2][3][7].

Summary of OS Therapies Conference Call Company Overview - **Company Name**: OS Therapies - **Ticker Symbol**: OSTX - **Industry**: Clinical-stage drug development, specifically oncology immunotherapy - **Focus**: Developing a Listeria-based cancer vaccine targeting tumor cells to enhance immune response [2][3] Core Points and Arguments - **Lead Program**: OST-HER2, targeting pediatric osteosarcoma, a type of bone cancer with no approved therapies for recurrent cases [3][4] - **Market Size**: Osteosarcoma affects approximately 1,000 cases annually in the U.S. and 20,000 globally, with a significant unmet medical need [8][22] - **Regulatory Milestones**: - Recent meetings with FDA, UK MHRA, and EMA to discuss approval pathways [4][12] - Expecting to file for Biologics License Application (BLA) in Q1 2026 [13] - **Clinical Data**: - Phase 2b study showed event-free survival of 36% at 12 months compared to a historical control of 20% [11] - Overall survival at 75% at the two-year mark, significantly higher than the 40% historical control [12] - **Priority Review Voucher (PRV)**: - Anticipated value of PRV could exceed $150 million, which could significantly fund further development [13][20] - PRV allows expedited review for drugs targeting rare diseases, making it attractive for larger pharmaceutical companies [20][21] Additional Important Information - **Spinout Company**: K9 Animal Health Program, which has received conditional approval from USDA for canine use, leveraging the same Listeria technology [4][14] - **Scientific Advisory Board**: Composed of top-tier university hospitals and foundations, indicating strong backing and credibility [7] - **Institutional Investors**: Recent filings show interest from notable institutional investors such as Millennium, State Street, and BlackRock [18] - **Future Focus**: While there are other potential indications for HER2, the company is currently focused on osteosarcoma before expanding to other cancers [16][17] Conclusion OS Therapies is positioned in a niche market with a promising lead program targeting pediatric osteosarcoma, backed by significant clinical data and regulatory milestones. The potential financial impact of the PRV and the interest from institutional investors further enhance the company's outlook.

OS Therapies Announces Successful pre-Marketing Authorisation Application Meeting with UK MHRA Regarding the Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic OsteosarcomaDecember 09, 2025 7:40 AM EST | Source: OS TherapiesAlignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study designBiomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with p ...

OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation EligibilityDecember 05, 2025 8:01 AM EST | Source: OS TherapiesU.S. FDA grants waiver of application fee for BLA Filing of OST-HER2Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on December 8, 2025Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025New York, New York--(Newsfile Corp. - Dece ...

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 ...

Core Insights - OS Therapies Inc. (OSTX) is advancing towards bringing OST-HER2 to patients with recurrent, fully resected, pulmonary metastatic osteosarcoma, with significant clinical and regulatory milestones achieved in 3Q25 [1][3] - The company reported a 2-year overall survival (OS) rate of 75% for OST-HER2 compared to 40% in historical controls, with 100% 2-year survival among patients who were event-free at 12 months [1][5] - A planned spinoff of OS Animal Health (OSAH) into a standalone public company is expected in 1H26, allowing OSTX shareholders to receive direct equity participation [1][5] Regulatory Developments - The regulatory path is on track with a UK pre-MAA submission in December and FDA Type C filings targeted for January 2026, supported by the Phase 2b trial results [5] - The company is preparing for harmonized U.S. and ex-U.S. filings, with submissions to the UK MHRA and FDA expected around year-end [1][5] Financial Overview - As of the end of the quarter, OS Therapies had approximately $1.9 million in cash and reported a net loss of $6.9 million [5] - Post-quarter, the company secured $7.8 million in warrant proceeds and has an At-The-Market (ATM) facility in place, extending its financial runway into late 2026 [5]

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 ...