OS Therapies Incorporated

Sep 8, 2026

OS Therapies Achieves Statistically Significant Benefit for OST-HER2-Treated Patients in Interim 3-Year Overall Survival Analysis of Phase 2b Pulmonary Metastatic Osteosarcoma Trial

OS Therapies announced a statistically significant overall survival benefit for patients treated with OST-HER2 in a Phase 2b trial for pulmonary metastatic osteosarcoma. The interim analysis showed a 71.2% survival rate compared to 45.8% in historical controls. The company is preparing for regulatory submissions to the FDA and other agencies, aiming for market access in 2027.

OS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates

OS Therapies reported its financial results for Q2 2026, highlighting significant progress in its regulatory submissions for OST-HER2, a treatment for pulmonary metastatic osteosarcoma. The company is preparing for key FDA and MHRA meetings to align on trial designs and statistical methods. Financially, they secured up to $10 million in debt financing, supported by VAT refunds and R&D tax credits.

Aug 13, 2026

OS Therapies Granted U.S. FDA Type C Statistical Methods Meeting to Review 2.5-Year Overall Survival Data for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma

OS Therapies has received FDA approval for a Type C Statistical Methods meeting to review 2.5-year overall survival data for OST-HER2 in osteosarcoma. The meeting is scheduled for mid-September 2026, where the company will discuss the appropriateness of using historical control data. The company anticipates announcing interim 3-year survival data shortly before this meeting.

OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program

OS Therapies has accepted a meeting request from the FDA's CDER to review its OST-HER2 biomarker data as part of the BEST Program. This meeting will occur alongside a Type B Statistical Methods Meeting with CBER. The company is preparing for a Biologics License Application submission expected in early Fall 2026, following positive results from its clinical trials.

Jul 6, 2026

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OS Therapies Third Quarter 2026 Corporate Outlook

OS Therapies provided a corporate outlook for Q3 2026, highlighting key milestones for its OST-HER2 program targeting metastatic osteosarcoma. The company has aligned with regulatory bodies in Europe and Australia for Conditional Marketing Authorisation Applications, with a Phase 3 study expected to start soon. Positive survival data strengthens its case for early market access in the U.S. and abroad.

Jul 2, 2026

OS Therapies Appoints Dr. Craig Eagle to Board of Directors

OS Therapies has appointed Dr. Craig Eagle to its Board of Directors, enhancing its leadership. The company secured a $10 million line of credit, which will support the commercial manufacturing of its lead asset, OST-HER2. Positive results from a Phase 2b trial bolster the company's confidence as it prepares for regulatory submissions in the U.S. and Europe.

Jun 30, 2026

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OS Therapies Provides U.S. Regulatory Update

OS Therapies provided a regulatory update regarding its Biologics License Application for OST-HER2. The company is seeking alignment with the FDA on overall survival data as an approval endpoint, following positive interactions with the MHRA and EMA. Additionally, they are incorporating data from the OST-400 study as a synthetic control for their application under the Accelerated Approval Program.

Jun 26, 2026

OS Animal Health Announces Peer-Reviewed Publication of Clinical Trial Data for OST-HER2 Plus Palliative Radiation as Frontline Treatment in Canine Osteosarcoma

OS Animal Health announced the publication of Phase 2 clinical trial data for OST-HER2 combined with palliative radiation therapy in treating canine osteosarcoma. The results showed a significant improvement in survival rates, with 20% of treated dogs surviving two years compared to just 1% in the control group. The company plans to seek regulatory alignment with the USDA for conditional approval by Q3 2026.

Jun 8, 2026

OS Therapies Achieves Global Regulatory Alignment on Design of Phase 3 Trial of OST-HER2 in Fully Resected, Pulmonary Metastatic Osteosarcoma

OS Therapies has secured regulatory alignment for its Phase 3 trial of OST-HER2 in pulmonary metastatic osteosarcoma. The trial will utilize the drug product from the Phase 2b study and is expected to commence in Australia by late Q3 2026. This alignment with the FDA, MHRA, EMA, and TGA positions the company for potential regulatory decisions by year-end 2026.

Jun 2, 2026

OS Therapies Achieves Statistically Significant 2.5-Year Overall Survival in Phase 2b Trial of OST-HER2 in Fully Resected Pulmonary Metastatic Osteosarcoma

OS Therapies announced that its Phase 2b trial of OST-HER2 for pulmonary metastatic osteosarcoma achieved a statistically significant overall survival rate of 75% at the 2.5-year mark, compared to 47% in historical controls. The company is preparing to submit updated clinical efficacy data to regulatory agencies in the U.S., U.K., Europe, and Australia, aiming for early market access by late 2026. Upcoming meetings with regulatory bodies are set to align on critical data for market authorization.

May 29, 2026

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OS Therapies Announces the Publication of Four Articles on OST-HER2 and Osteosarcoma in Drug Discovery World

OS Therapies has announced the publication of four articles focusing on OST-HER2 and its implications for osteosarcoma treatment. These publications aim to provide significant insights into the therapeutic potential of OST-HER2. The initiative reflects the company's dedication to advancing research in the field of oncology.

May 26, 2026

OSTXConferences/Events

OS Therapies to Attend Upcoming Medical, Financial and Industry Conferences

OS Therapies, Inc. will participate in several upcoming medical and financial conferences, including the ASCO 2026 and Jefferies Healthcare Conference. The company is focused on advancing its lead asset, OST-HER2, which has shown promising results in clinical trials for osteosarcoma. They expect to submit a Biologics License Application to the FDA in 2026.

Apr 30, 2026

OS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected Pulmonary Metastatic Osteosarcoma Conference

OS Therapies has announced that the European Medicines Agency (EMA) has initiated a Rolling Review of its Conditional Marketing Authorization application for OST-HER2, aimed at preventing recurrence in pulmonary metastatic osteosarcoma. The review process is expected to extend into late 2026, when the company anticipates receiving a decision. Alongside this, OS Therapies is also pursuing market authorization in the UK and Australia. These developments underscore the company's focus on advancing OST-HER2's regulatory progress while preparing for a confirmatory Phase 3 trial.

Apr 13, 2026

OS Therapies Appoints Biotech Industry Luminary Robert “Bob” S. Langer, PhD as Strategic Advisor

OS Therapies has appointed Dr. Robert S. Langer as a strategic advisor. Dr. Langer is a prominent figure in the biotech industry, known for his significant contributions to the field. His expertise is expected to guide OS Therapies in its future endeavors and innovation strategies.

Apr 2, 2026

OS Therapies Completes $5.25M Registered Direct Offering Primarily with Pre-Existing High-Net-Worth Investors Company expects approximately $2 million in non-dilutive VAT refunds from wholly owned U.K. subsidiary in 2Q-2

OS Therapies, Inc. has completed a $5.25 million registered direct offering mainly funded by high-net-worth investors. The company anticipates an additional $4 million in VAT refunds from its U.K. subsidiary, which will support its operations as it works towards critical regulatory milestones for its lead therapy, OST-HER2. This therapy has received various designations from regulatory bodies, with an upcoming focus on crucial meetings with agencies like the FDA and EMA. Furthermore, OS Therapies is optimistic about gaining early market access for osteosarcoma treatments in 2027.

Mar 27, 2026

OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarcoma

OS Therapies has been granted meetings with the U.S. FDA, U.K. MHRA, EMA, and the Australian Therapeutic Goods Administration. These meetings are to discuss the global confirmatory Phase 3 trial for OST-HER2, aimed at treating metastatic osteosarcoma. This development marks a significant step forward in the company's clinical efforts.

OS Therapies Announces FDA OST-HER2 Type D Meeting Elevated to Type B Pre-BLA Meeting

OS Therapies has announced that its FDA OST-HER2 Type D meeting has been elevated to a Type B Pre-BLA meeting. This advancement suggests a positive trajectory for the company as it prepares for a Biologics License Application. The elevation indicates increased regulatory engagement and support from the FDA.

Feb 2, 2026

OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma

OS Therapies has initiated a Biologics License Application (BLA) filing with the US FDA for its drug OST-HER2. This filing aims to address the prevention or delay of recurrent pulmonary metastatic osteosarcoma in patients who have undergone complete resection. The move signifies a significant step toward providing new treatment options for this challenging cancer.

OS Therapies Enters into Warrant Inducement Agreements $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

OS Therapies Inc. (NYSE-A: OSTX) announced the launch of warrant exercise inducement agreements with nine accredited investors, raising $7.53 million in gross proceeds. These funds will provide the company a financial runway into 2027, allowing it to support regulatory filings and commercial preparations for its lead asset, OST-HER2. Additionally, the company is set to file a Biologics Licensing Application by the end of January 2026 and is planning a spinoff of its subsidiary, OS Animal Health. However, potential outcomes related to these developments and the feasibility of the spinoff remain uncertain.

OS Therapies Provides First Half 2026 Corporate Outlook

OS Therapies has released its corporate outlook for the first half of 2026. The announcement provides insights into the company's strategic direction and anticipated developments during this period. Specific details regarding product launches or financial projections were not disclosed in the article.

Oct 17, 2025

NYSE American: OSTX Corporate Presentation October 2025 NYSE American: OSTX 2 Safe Harbor Statement This document contains forward - looking statements . In addition, from time to time, we or our representatives may make

Osteosarcoma Technologies (OSTX) has presented an overview of its corporate strategy leading up to a significant milestone in FDA approvals for its lead product candidate, OST-HER2, particularly for human and canine osteosarcoma. The presentation highlighted the substantial financial investments made into its innovative listeria-based cancer therapies and the clinical pipeline's potential market opportunity. However, the company acknowledged the risks associated with early-stage development, lack of predictable revenue, and challenges in gaining regulatory approvals. These factors warrant careful consideration for investors evaluating OSTX's future prospects.

OS Therapies Completes Exercise Inducement and Exchange Offer for All Remaining Outstanding Warrants Issued in Connection with December 2024 Financing All remaining holders of outstanding warrants with $1.12 per share ex

OS Therapies Inc. has successfully completed a warrant inducement and exchange offer, raising approximately $3.7 million. This funding will be used to advance preparations for the commercialization of its lead product, OST-HER2, targeting osteosarcoma. The company aims for regulatory approval and commercialization by early 2026 but acknowledges that these plans are dependent on FDA decisions. Additionally, the transaction reduces the risk of short selling and positions the company for additional funding through new warrants.

OS Therapies Terminates Equity Line of Credit New York, NY

OS Therapies Inc. announced the termination of its Equity Purchase Agreement with Square Gate Capital Master Fund effective August 26, 2025. The company recently secured $4.2 million from a warrant exercise, providing funding until mid-2026. OS Therapies reported positive data from its Phase 2b clinical trial for OST-HER2 and plans to submit a Biologics Licensing Application to the FDA in 2025. The company is concentrating its efforts on advancing its lead asset in osteosarcoma while analyzing data from trials in prostate cancer.

Aug 19, 2025

OS Therapies Reports Second Quarter 2025 Financial Results and Provides Business Update U.S. FDA ("FDA") confirms OST-HER2 meets biological definition of Regenerative Medicine Advanced Therapy (RMAT) FDA issues OST-HER2

OS Therapies Inc. reported its second quarter 2025 financial results and significant advancements for its lead immunotherapy candidate, OST-HER2, aimed at treating osteosarcoma. The company highlights strong clinical trial results showing improved survival rates and plans to submit a Biologics Licensing Application (BLA) to the FDA. OS Therapies is also working to synchronize the approval processes with the UK and EU regulators. Despite a higher net operating loss in this quarter compared to the previous year, the company sees potential financial benefits from a priority review voucher related to OST-HER2's designation as a treatment for a rare pediatric disease.

OS Therapies Closes $4.2 million in Warrant Exercise Inducement and Exchange Offer Cash runway extended through 2026, beyond

OS Therapies has successfully closed a warrant exercise inducement and exchange offer, raising $4.2 million to enhance its financial position and extend its operational runway into 2026. This capital will support regulatory and commercial efforts related to the lead drug candidate, OST-HER2, aimed at treating recurrent pulmonary metastatic osteosarcoma. The company is also advancing other projects, including an AI-driven product candidate modeling initiative. Overall, these developments indicate a positive outlook for OS Therapies as it prepares for upcoming milestones in its drug development pipeline.

Jun 24, 2025

OS Therapies Announces Warrant Exercise Inducement & Exchange Offer Current holders of five-year warrants with a current exercise price of $1.12 per share issued in connection with PIPE transaction initially closed on

OS Therapies has launched a warrant exercise inducement and exchange offer for holders of its five-year warrants, potentially raising approximately $8 million in gross cash proceeds. The company will utilize these funds to advance the clinical development of OST-HER2 and other regulatory efforts. OST-HER2 has received Rare Pediatric Disease Designation from the FDA, and the company plans to submit a Biologics Licensing Application in the third quarter of 2025. The offering will be available from June 20 to July 10, 2025.

May 16, 2025

OS Therapies Reports First Quarter 2025 Financial Results and Provides Business Update Feeback from Type D FDA Meeting expected by mid-June 2025 to confirm statistical analysis methods to be used to support pending Accel

OS Therapies Inc. reported its first quarter 2025 financial results, noting a significant net operating loss due to trial expenses. The company announced encouraging outcomes from the OST-HER2 Phase 2b trial aimed at preventing recurrent pediatric osteosarcoma and plans to seek Accelerated Approval from the FDA. Additionally, OS Therapies consolidated its therapeutic platform pipeline and reduced its operational burn rate, ensuring financial stability moving forward. The company is positioned to potentially introduce the first new treatment for osteosarcoma in several decades.

Apr 9, 2025

OS Therapies Completes Acquisition of Advaxis Immunotherapies Clinical, Pre-clinical and IP Assets from Ayala Pharmaceuticals Company now listeria-based cancer immunotherapy world leader Expands clinical pipeline with 3

OS Therapies has completed the acquisition of Advaxis Immunotherapies' listeria-based cancer immunotherapy assets from Ayala Pharmaceuticals. This positions OS Therapies as a leader in this field and enhances their clinical pipeline with three new candidates. The company's lead asset, OST-HER2, is expected to receive priority drug approval in late 2025 after successful trial results. OS Therapies plans to utilize its acquired intellectual property to advance treatment outcomes in cancer therapy.

Mar 31, 2025

OS Therapies Reports Full Year 2024 Financial Results and Provides Business Update Full data from OST-HER2 Phase 2b osteosarcoma trial, including synthetic control arm data being developed at the request of FDA to suppor

OS Therapies Inc. has announced its financial results for the full year 2024, highlighting a transformative year with the completion of an IPO and the Phase 2b clinical trial for its lead product, OST-HER2. The company anticipates reduced operational costs moving forward, with cash expected to last through to 2026. OST-HER2, which has shown promising results in trials, is aimed at treating osteosarcoma and has received multiple regulatory designations. However, the company also reported a net operating loss increase from the previous year.

OS Therapies Announces Closing of $6 Million Private Placement Funding expected to provide cash runway into 2026 98% of investment in private placement from Pre-IPO and/or IPO investors Data update from OST-HER2 Phase 2b

OS Therapies, Inc. announced the successful closing of a $6 million private placement funding aimed at supporting the clinical and regulatory milestones necessary for the commercialization of its lead therapeutic candidate, OST-HER2. This financing is expected to ensure the company's operational sustainability through 2026 and help in achieving FDA approval for treating recurrent, resected metastatic osteosarcoma. Additionally, the company anticipates earning a priority review voucher (PRV) valued at approximately $150 million, which could be instrumental in further expanding its clinical development efforts.

Dec 24, 2024

OS Therapies Announces Pricing of $6 Million Private Placement Funding will provide Company sufficient cash runway into 2026 95% of investment in private placement from Pre-IPO and/or IPO investors Data from OST-HER2 Pha

OS Therapies, Inc. announced a $6 million private placement to strengthen its financial position, providing cash runway into 2026. The funding will focus on advancing the commercialization of its lead candidate, OST-HER2, designed for treating recurrent osteosarcoma. With a recent Phase 2b clinical trial completed, the company aims to leverage its immunotherapy platform further. The private placement is expected to close by December 27, 2024, pending customary conditions.

Nov 15, 2024

OS Therapies Reports Third Quarter 2024 Financial Results and Provides Business Update Topline Data from Phase 2b clinical trial of OST-HER2 in Osteosarcoma expected to be released in December 2024 New York, NY

OS Therapies, Inc. reported its financial results for Q3 2024, highlighting significant progress with its Phase 2b trial of OST-HER2 in osteosarcoma. The company has finished dosing all 41 patients and anticipates releasing topline data in December 2024. OS Therapies received multiple FDA designations for OST-HER2, enhancing its position for potential regulatory approvals. However, the company continues to operate at a loss and has not yet generated revenue.

Oct 28, 2024

OS Therapies Appoints Two Bio-Pharmaceutical Industry Veterans to the Board of Directors Concurrently, the Company accepted the resignations of Dr. Colin Goddard and Mr. Joacim Borg New York, NY

OS Therapies has announced the appointment of Avril McKean Dieser and Olivier R. Jarry as independent members of its Board of Directors. Both individuals bring over 50 years of biopharmaceutical experience that will aid OS Therapies in regulatory approval and commercialization efforts for its cancer immunotherapy, OST-HER2. The company is preparing for a pivotal trial and aims to develop strategic partnerships to enhance market reach. Additionally, both new appointees have expressed a commitment to advancing innovative treatments for osteosarcoma and other cancers.

Aug 22, 2024

OS Therapies Clarifies CUSIP of Common Stock New York, NY

OS Therapies has issued a clarification regarding the CUSIP identifiers for its common stock. The company transitioned from an Old CUSIP to a New CUSIP due to corporate actions before its listing on the NYSE American. OS Therapies is focused on developing treatments for osteosarcoma and other solid tumors, with ongoing clinical trials for its lead asset, OST-HER2. Results from a Phase 2b trial are anticipated in the fourth quarter of 2024.

Jul 31, 2024