Core Viewpoint - OS Therapies Inc. is advancing its regulatory strategy for OST-HER2, a listeria-based cancer immunotherapy, with significant upcoming data releases and regulatory submissions aimed at preventing recurrent pulmonary metastatic osteosarcoma [1][2][3][4]. Regulatory Updates - The company submitted the Non-Clinical and Chemistry, Manufacturing & Controls (CMC) modules of its Biologics License Application (BLA) to the FDA at the end of January 2026 and plans to release additional biomarker data in Q1 2026 [2]. - Conditional Marketing Authorisation Applications (MAAs) are expected to be submitted to the U.K. MHRA and the EMA by the end of Q1 2026, with a Clinical BLA module submission to the FDA anticipated after a Type D meeting in March 2026 [3]. Biomarker Data and Clinical Trials - OS Therapies is conducting follow-on biomarker analyses to further understand the drug's treatment effects and their relationship to clinical outcomes, with data expected to be shared soon [4]. - The company is assembling a meeting with key opinion leaders in osteosarcoma to review clinical and biomarker data and discuss confirmatory trial designs, with plans to initiate a confirmatory trial in Q3 2026 [4][11]. Designations and Financial Implications - OST-HER2 has received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA, making it eligible for a Priority Review Voucher (PRV) upon Accelerated Approval, which could be sold for significant value [5]. - The most recent PRV transaction was valued at $200 million [5]. Acquisition and Corporate Developments - OS Therapies acquired listeria-based assets from Ayala Pharmaceuticals in April 2025, and Ayala has since announced its dissolution following the liquidation of its assets [6].

Core Insights - OS Therapies Inc. celebrates the passage of the Mikaela Naylon Give Kids A Chance Act, which aims to enhance research and therapeutic access for pediatric cancer patients, particularly those with osteosarcoma [1][5] - Pediatric cancers are the leading cause of disease-based death among children in the U.S., highlighting the urgent need for innovative treatments [2] - The reauthorization of the Rare Pediatric Disease Designation (RPDD) Priority Review Voucher (PRV) program allows OS Therapies to extend its timeline for submitting a Biologics License Application (BLA) for its lead product, OST-HER2, until September 30, 2029 [3][6] Company Developments - OS Therapies is focused on developing listeria-based cancer immunotherapies, with OST-HER2 being its lead asset, which has shown positive results in clinical trials for recurrent pulmonary metastatic osteosarcoma [7] - The company is also evaluating other pipeline products for potential PRV opportunities and benefits under the FDA Platform Technology Designation Program [4] - OST-HER2 has received multiple designations from regulatory bodies, including Orphan Disease Designation and Fast Track Designation, which facilitate its development and potential market entry [6][7] Future Prospects - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [8] - OS Therapies is committed to transforming the lives of children and teens affected by osteosarcoma and other rare cancers, building on the legacy of patients like Mikaela Naylon [5]

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 Insights - OS Therapies Inc. is a clinical-stage biotechnology company focused on cancer immunotherapy and antibody drug conjugates, particularly for Osteosarcoma and other solid tumors [1][2] - The company's lead asset, OST-HER2, has shown positive results in a Phase 2b clinical trial for recurrent lung metastatic osteosarcoma, achieving statistically significant benefits in the 12-month event-free survival primary endpoint [1] - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, and the company plans to submit a Biologics Licensing Application in 2025 [1] - The company is also developing a next-generation Antibody Drug Conjugate platform known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [2] Upcoming Events - OS Therapies will participate in several investor conferences in September 2025, including the Cantor Global Healthcare Conference from September 3-5, H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, and Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11 [5]

Core Insights - OS Therapies has completed a warrant inducement and exchange offer, raising approximately $3.7 million in gross proceeds to accelerate preparations for the commercial launch of OST-HER2 [1][4] - The company aims to bring OST-HER2 to market in early 2026, pending FDA regulatory approval [2] - New warrants have been issued with an exercise price of $3.00 per share, which includes a forced exercise provision when the stock trades above $9.00, potentially bringing in over $20 million in additional funding [2][4] Financial Details - The warrant exchange raised approximately $3.7 million, which will primarily be used for commercial preparations related to OST-HER2 [1][4] - The forced exercise provision of the new warrants could lead to over $20 million in additional funding if triggered [2] Product Development - OST-HER2 is the lead asset of OS Therapies, targeting osteosarcoma and has received multiple designations from the FDA, including Rare Pediatric Disease Designation [3][5] - The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025, which could lead to a Priority Review Voucher if approved [5] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) technology, known as tunable ADC (tADC) [6]

Core Viewpoint - OS Therapies has terminated its Equity Purchase Agreement with Square Gate Capital Master Fund, effective August 26, 2025, and has successfully raised $4.2 million through a warrant exercise inducement and exchange offering to fund operations into mid-2026 [1][2]. Group 1: Financial Developments - The termination of the Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund is effective August 26, 2025 [1]. - The company raised $4.2 million in gross proceeds from a recent warrant exercise inducement and exchange offering, which will support operations through mid-2026 [2]. Group 2: Clinical Trials and Product Development - The treatment phases of the Phase 2b OST-HER2 clinical trial in osteosarcoma and the Phase 1b OST-504 clinical trial in prostate cancer are now complete, leading to a projected monthly burn rate in the second half of 2025 that is significantly lower than in the first half [3]. - OS Therapies plans to allocate capital primarily to drive towards approval for OST-HER2 in osteosarcoma while analyzing data from OST-504 for future development steps [3]. Group 3: Company Overview and Product Pipeline - OS Therapies is focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset, OST-HER2, leveraging immune-stimulatory effects to target the HER2 protein [4]. - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and the company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025 [4]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [5].

Core Insights - OS Therapies Inc. will report its second quarter 2025 financial results and provide a business update on August 19, 2025 [1] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for Osteosarcoma and other solid tumors [2] - The lead asset, OST-HER2, is an immunotherapy that targets the HER2 protein and has received multiple designations from the U.S. FDA and European Medicines Agency [2] - Positive data from a Phase 2b clinical trial of OST-HER2 in lung metastatic osteosarcoma showed statistically significant benefits in the 12-month event-free survival primary endpoint [2] - The company plans to submit a Biologics Licensing Application for OST-HER2 in 2025, which could lead to a Priority Review Voucher if approved [2] - OST-HER2 has also shown preclinical efficacy in breast cancer models and has been conditionally approved for treating canines with osteosarcoma [2] Product Development - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for tailored antibody-linker-payload candidates [3] - The tADC platform allows for the delivery of multiple payloads per linker, enhancing treatment options [3]

Core Viewpoint - OS Therapies has successfully closed a warrant exercise inducement and exchange offer, raising $4.2 million to support its regulatory and pre-commercial efforts for its lead product, OST-HER2, aimed at treating osteosarcoma [1][2]. Financial Summary - The company raised a total of $4.2 million in gross proceeds from the offering [1]. - The funds will primarily be used for regulatory efforts and to advance strategic alternatives for its OS Animal Health subsidiary [1][2]. Product Development - OST-HER2 is the lead asset of OS Therapies, designed to treat recurrent, fully resected pulmonary metastatic osteosarcoma, and has received various designations from the FDA [3][4]. - The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025, which could yield a Priority Review Voucher (PRV) if approved [4]. - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), utilizing proprietary technology [5]. Strategic Plans - The company aims to pursue a Biologics Licensing Authorization under the Accelerated Approval Program for OST-HER2 within the next 18 months [2]. - OS Therapies intends to evaluate strategic alternatives for its canine osteosarcoma program and report final data for its OST-504 prostate cancer study [2][3]. - The company is focused on improving the treatment landscape for metastatic osteosarcoma patients while minimizing cash expenditure [2].