OSTX May 29, 2026OSTXGeneral
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.
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OSTX Apr 30, 2026OSTXFDA Updates
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.
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OSTX Apr 13, 2026OSTXGeneral
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.
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OSTX Apr 2, 2026OSTXGeneral
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.
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OSTX Mar 27, 2026OSTXFDA Updates
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.
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OSTX Mar 9, 2026OSTXFDA Updates
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.
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OSTX Feb 2, 2026OSTXFDA Updates
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.
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OSTX Jan 12, 2026OSTXGeneral
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.
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OSTX Jan 5, 2026OSTXGeneral
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.
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OSTX Oct 17, 2025OSTXGeneral
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.
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OSTX Sep 2, 2025OSTXGeneral
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.
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OSTX Aug 25, 2025OSTXGeneral
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.
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OSTX Aug 19, 2025OSTXFDA Updates
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.
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OSTX Jul 14, 2025OSTXGeneral
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.
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OSTX Jun 24, 2025OSTXGeneral
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.
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OSTX May 16, 2025OSTXFDA Updates
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.
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OSTX Apr 9, 2025OSTXGeneral
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.
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OSTX Mar 31, 2025OSTXPhases
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.
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OSTX Dec 31, 2024OSTXGeneral
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.
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OSTX Dec 24, 2024OSTXGeneral
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.
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OSTX Nov 15, 2024OSTXPhases
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.
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OSTX Oct 28, 2024OSTXGeneral
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.
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OSTX Aug 22, 2024OSTXGeneral
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.
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OSTX Jul 31, 2024OSTXGeneral
OS Therapies Reports Second Quarter 2024 Financial Results Successful IPO that raised $6.4 million on
OS Therapies, Inc. reported its financial results for the second quarter of 2024, highlighting a successful IPO that raised $6.4 million, providing sufficient cash to fund operations through mid-2025. The company is progressing in its Phase 2b clinical trial for its leading product, OST-HER2, in recurrent osteosarcoma, with anticipated data readout by the fourth quarter of 2024. They noted a decrease in their operational losses compared to the previous year, while also emphasizing their pre-revenue status and ongoing efforts to secure revenue through licensing agreements.
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