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. Her legacy through this legislation will accelerate critical opportunities for research and therapeutic access for other children an ...

Request for FDA Rolling Review submitted to FDA on January 30, 2026Non-Clinical and CMC BLA modules submitted to FDAAt 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 caninesFinal 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 updat ...

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.OST-HER2, the company’s lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 proteinOSTX Clinical Trial Data Signals Regulatory Approval PathThe company reported that ...

Company Overview - OS Therapies Inc. is a leader in listeria-based cancer immunotherapies, focusing on treatments for osteosarcoma and other solid tumors [8] - The company is preparing for an Initial Public Offering (IPO) for its subsidiary OS Animal Health Corp (OSAH) in the first half of 2026 [1][5] - OSAH aims to commercialize OST-HER2, an immunotherapy for canine osteosarcoma and HER2-positive cancers in animals [5][7] Research and Development - A 2023 study highlighted similarities between human and canine osteosarcoma, indicating that a robust immune response improves clinical outcomes [2] - Data from canine studies of OST-HER2 showed upregulation of immune activation biomarkers that correlate with better outcomes [2][3] - OST-HER2 has demonstrated potential in improving patient outcomes in canine osteosarcoma, including preventing metastatic disease and amputation [4] Market Opportunity - The veterinary oncology market is projected to grow from $1.58 billion in 2024 to $4.77 billion by 2034, primarily driven by North America [3] - The canine cancer segment is expected to grow at a rate of 12.56% from 2025 to 2030, attributed to rising cancer prevalence and increased awareness of treatment options [3] Regulatory and Approval Status - OS Therapies is pursuing a Biologics Licensing Application (BLA) for OST-HER2 under the Accelerated Approval Program for human osteosarcoma [3][8] - OST-HER2 has received conditional approval from the USDA for treating canine osteosarcoma and is part of the National Cancer Institute's Comparative Oncology Program [6][8]

Core Viewpoint - OS Therapies Inc. has launched a warrant exercise inducement and exchange offer to nine accredited investors, raising a total of $7.53 million in gross proceeds to support its ongoing projects and regulatory filings [1][3]. Group 1: Financial Details - The gross proceeds of $7.53 million will provide the company with a financial runway into 2027 [3]. - All nine investors who were offered the inducement have agreed to participate in the exercise of their existing warrants [7]. Group 2: Regulatory and Development Plans - The company plans to use the net proceeds to support regulatory filings and commercial preparation activities for its lead asset, OST-HER2, aimed at treating pulmonary metastatic osteosarcoma [3]. - OS Therapies intends to file a Biologics Licensing Application (BLA) with the U.S. FDA by the end of January 2026 and expects to submit Marketing Authorisation Applications (MAA) to the UK and EU regulatory bodies by February and March 2026, respectively [4][5]. - The company is hopeful for regulatory approval for OST-HER2 in the UK by Q2 2026, in the U.S. by Q3 2026, and in Europe by Q4 2026 [4]. Group 3: Product Designations and Market Potential - OST-HER2 has received Orphan Disease Designation and Fast Track Designation from the FDA, as well as Rare Pediatric Disease Designation, which may allow the company to receive a Priority Review Voucher (PRV) if it gains Accelerated Approval before September 30, 2026 [5]. - The most recent PRV sale was valued at $160 million, indicating significant market potential for the company if it successfully monetizes a future PRV [5]. Group 4: Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leveraging listeria-based cancer immunotherapies [9]. - The company reported positive data from its Phase 2b clinical trial of OST-HER2, demonstrating significant benefits in the primary endpoint of 12-month event-free survival [9].

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].

Core Insights - OS Therapies Inc. is positioned to enhance the standard of care for metastatic osteosarcoma with its lead candidate OST-HER2, with significant regulatory submissions planned for 2026 [3][4][5] Regulatory Submissions - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA by the end of January 2026 under the Accelerated Approval Program [4] - Marketing Authorization Applications (MAA) for conditional approval are expected to be submitted to the U.K. MHRA and the European EMA by the end of February 2026 and March 2026, respectively [4][5] Clinical Data and Milestones - Phase 2b biomarker data from the Metastatic Osteosarcoma Program is anticipated to be released during the week of the J.P. Morgan Healthcare Conference in January 2026 [2][12] - The company expects to engage in multiple meetings with regulatory authorities in the first half of 2026 to discuss clinical efficacy endpoints and trial designs [5] Designations and Incentives - OST-HER2 has received Orphan Disease Designation (ODD), Fast Track Designation, and Rare Pediatric Disease Designation (RPDD) from the FDA, making it eligible for a Priority Review Voucher (PRV) if approved before September 30, 2026 [6][9] Future Developments - The company is advancing its OS Animal Health subsidiary towards a go-public transaction, with a confidential SEC filing expected in early January 2026 [7][12] - Additional oncology programs, including OST-503 and OST-504, are also in development, with key meetings with the FDA planned for 2026 [8][12]

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.

Core Viewpoint - OS Therapies has successfully completed a pre-Marketing Authorisation Application meeting with the UK MHRA for its Phase 2b clinical trial of OST-HER2, aimed at preventing or delaying recurrent pulmonary metastatic osteosarcoma [2][4] Group 1: Clinical Trial and Regulatory Progress - The company achieved full alignment on key points regarding non-clinical, chemistry, manufacturing, and controls (CMC), and post-market authorization confirmatory study design during the pre-MAA meeting [6] - The company plans to submit a conditional MAA for the Metastatic Osteosarcoma Program to the MHRA by the end of January 2026 [4][6] - A meeting with the US FDA is scheduled for December 11, 2025, to discuss biomarker data analysis, which is crucial for supporting a Biologics Licensing Application under the Accelerated Approval Program [3][6] Group 2: Clinical Efficacy and Future Plans - The Phase 2b clinical trial of OST-HER2 demonstrated statistically significant benefits in the 12-month event-free survival primary endpoint [7] - The company anticipates submitting a Biologics Licensing Application to the US FDA for OST-HER2 in osteosarcoma in the first quarter of 2026, which could lead to eligibility for a Priority Review Voucher [7] - OST-HER2 has received various designations from the US FDA, including Rare Pediatric Disease Designation and Fast-Track designation, indicating its potential significance in treating osteosarcoma [5][7] Group 3: Product Development and Innovation - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [8]