Core Insights - OS Therapies has received a waiver from the U.S. FDA for the application fee related to BLA 125867 for its lead product OST-HER2, which is a listeria-based cancer immunotherapy [1][6] - The European Medicines Agency (EMA) has granted eligibility for Union Marketing Authorisation for OST-HER2 in the prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma, with a request for an accelerated Marketing Authorisation Application by February 28, 2026 [2] - The company is preparing for pre-Marketing Authorisation Application meetings with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. FDA to discuss final commercial considerations and study designs [3][6] 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 has received multiple designations from regulatory bodies, including Rare Pediatric Disease Designation and Fast-Track and Orphan Drug designations from the U.S. FDA and EMA [4] - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival primary endpoint [4] Future Developments - The company anticipates submitting a Biologics Licensing Application (BLA) for OST-HER2 in early 2026, which could lead to eligibility for a Priority Review Voucher [4] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery [5][7]

Core Viewpoint - OS Therapies has received approval from the World Health Organization for the non-proprietary name 'daznelimgene lisbac' for its cancer immunotherapy product candidate OST-HER2, which is aimed at treating pulmonary metastatic osteosarcoma [1][2][3]. Company Overview - OS Therapies is a clinical stage oncology company specializing in listeria-based cancer immunotherapies, particularly for osteosarcoma and other solid tumors [3]. - The company is recognized as a leader in listeria-based cancer immunotherapies and is developing OST-HER2 to leverage the immune-stimulatory effects of Listeria bacteria [3]. Product Development - OST-HER2 has received multiple designations from regulatory authorities, including Rare Pediatric Disease Designation (RPDD) from the U.S. FDA and Fast-Track and Orphan Drug designations from both the U.S. FDA and European Medicines Agency [3]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [3]. - A Biologics Licensing Application (BLA) for OST-HER2 is anticipated to be submitted to the U.S. FDA in early 2026, with the potential to receive a Priority Review Voucher if approved [3]. Future Plans - OS Therapies is on track to receive regulatory feedback from U.S., UK, and European authorities in December 2025, with plans to file for regulatory approvals starting in January 2026 [3]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [4].

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].

Clinical Trials and Regulatory Approvals - In Q1 2025, OS Therapies' Phase IIb clinical trial for OST-HER2 achieved a primary endpoint with 75% overall survival at two years, compared to 40% in historical controls (p < 0.0001) [207] - The company plans to submit a conditional Marketing Authorization Application to the MHRA in December 2025 and a Biologics License Application to the FDA in January 2026 [208] - The company intends to explore OST-HER2's potential in treating other solid tumors, including breast, esophageal, and lung cancers, following regulatory approval [209] - The company is analyzing patient samples from the Phase IIb trial to assess correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025 [208] - The OST-Tunable Drug Conjugate platform is being investigated for clinical indications in Osteosarcoma and other solid tumors [210] Financing and Capital Raising - OS Therapies completed a PIPE Financing on January 14, 2025, raising approximately $7.1 million through the issuance of 1,775,750 shares of Series A Preferred Stock and warrants [212] - The company has engaged Brookline Capital Markets as the exclusive placement agent for the PIPE Financing, with a cash fee of 7% on gross proceeds [213] - Gross proceeds from the Offerings were approximately $6,398,358, which will be used for regulatory efforts and general corporate purposes [225] - The company raised total gross proceeds of $41.1 million as of September 30, 2025, from various financing activities including private placements and an initial public offering [255] - The company has entered into a Sales Agreement to offer up to $18,000,000 in common stock, with a commission of up to 3.0% on gross sales price per share [275] Expenses and Financial Performance - Research and development expenses for the nine months ended September 30, 2025, were approximately $7.6 million, a significant increase from approximately $2.0 million for the same period in 2024 [246] - Operating loss for the nine months ended September 30, 2025, was $16,717,809 compared to a loss of $3,847,422 for the same period in 2024 [246] - General and administrative expenses for the nine months ended September 30, 2025, were $9,153,821, up from $1,878,831 in 2024 [246] - The company anticipates substantial increases in research and development expenses as it advances OST-HER2 and OST-tADC into clinical development [236] - For the nine months ended September 30, 2025, the company reported a net loss of approximately $15.3 million, compared to a net loss of $5.9 million for the same period in 2024, resulting in an accumulated deficit of approximately $55 million [254] Cash Flow and Financial Position - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $10.5 million, compared to $4.9 million for the same period in 2024 [256] - The company had cash of approximately $1.9 million as of September 30, 2025, down from $5.5 million as of December 31, 2024 [255] - Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $7.3 million, compared to $6.7 million for the same period in 2024 [261] Stockholder and Shareholder Matters - The issuance of shares related to the acquisition of HER2 assets required stockholder approval, which was obtained on April 9, 2025 [216] - The Series A preferred stock dividend requirement was $375,000 as of September 30, 2025, and has been consistent since December 31, 2024 [241] - The fair value of the Series A Warrants is subject to re-measurement at each balance sheet date until exercised or reclassified [232] Licensing and Agreements - The company has a licensing agreement with Advaxis, requiring a one-time payment of $1,550,000 and milestone payments based on specific achievements, with no payments made for the nine months ended September 30, 2025 [277] - The milestone payment schedule under the Advaxis agreement includes payments of $1,375,000 and $5,000,000 based on funding and regulatory approval milestones [278] - The company has a licensing agreement with BlinkBio, which includes an upfront fee of $300,000 and milestone payments totaling up to $22,375,000 [282] - The company has eliminated $3,500,000 in payments owed to Ayala upon the first filing of a BLA approval for OST-HER2 and reduced royalty consideration from 10% to 1.5% of net sales [279] Other Financial Matters - The company has not recorded income tax benefits for net operating losses due to uncertainty in realizing those benefits [242] - The adjustment of the fair value of the warrant liability was $1.4 million for the nine months ended September 30, 2025, compared to $0.0 million for the same period in 2024 [253] - The company has a contractual obligation of approximately $2,436,928 with George Clinical for clinical research services, with no payments made for the nine months ended September 30, 2025 [286] - The company paid $2,397,131 in consulting fees to Biolacuna Ltd for assistance in registering OST-HER2, with accounts payable of $2,022,496 as of September 30, 2025 [288] - The company has not engaged in any off-balance sheet arrangements during the reported periods [289] - The company remains an emerging growth company until certain revenue or filing thresholds are met, with total annual gross revenues of $1.235 billion or more being one of the criteria [293]

Core Insights - OS Therapies announced additional overall and event-free survival data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma, highlighting statistically significant positive outcomes [2][4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset OST-HER2 being an immunotherapy that targets the HER2 protein [4][6] - OST-HER2 has received several designations from regulatory agencies, including Rare Pediatric Disease Designation and Fast-Track status from the U.S. FDA [4] Clinical Trial Results - The Phase 2b Osteosarcoma Trial involved 41 patients, with subgroup analyses revealing: - For patients with a lung-only second or greater metastatic event, the 2-year overall survival rate was 80.0% [5] - For patients with a lung-only first metastatic event, the 2-year overall survival rate was 73.8%, significantly higher than the 30% natural history comparator (p < 0.0001) [5] - The company anticipates submitting a Biologics License Application (BLA) to the U.S. FDA for OST-HER2 in 2025 [6] Future Plans - OS Therapies is preparing for regulatory meetings with the FDA, MHRA, and EMA to discuss overall survival data and trial design for OST-HER2 [3] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [7]

Core Insights - OS Therapies has received a second Type C Meeting from the FDA to discuss clinical efficacy data endpoints for OST-HER2, aimed at supporting a Biologics Licensing Application under the Accelerated Approval Program following a successful Phase 2b trial for metastatic osteosarcoma [1][2] - The UK MHRA has granted a pre-MAA Meeting for the same program, with the company planning to align BLA and MAA submission timelines as part of Project Orbis [2] - The company reported positive results from its Phase 2b clinical trial, demonstrating statistically significant benefits in the 12-month event-free survival primary endpoint [6] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset OST-HER2 being an immunotherapy targeting the HER2 protein [4][6] - OST-HER2 has received multiple designations from regulatory agencies, including Rare Pediatric Disease Designation and Fast-Track status from the FDA [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 drug delivery [7] Clinical Development and Regulatory Strategy - The FDA meeting is scheduled for December 11, 2025, allowing time for the company to gather biomarker data to correlate immune activation with clinical outcomes [1][5] - The recent FDA/Osteosarcoma Institute Workshop emphasized the importance of overall survival data as a key efficacy endpoint and discussed appropriate clinical trial designs for future immunotherapies [3][5] - The company anticipates submitting a BLA for OST-HER2 in 2025, which, if approved, would make it eligible for a Priority Review Voucher [6]

Core Insights - OS Therapies announced statistically significant positive final 2-year overall survival data from the Phase 2b trial of OST-HER2, showing 75% of treated patients achieved 2-year overall survival compared to 40% in historical controls [1][4] - The company is on track to file for conditional marketing authorization in the UK, the US, and the EU, with key regulatory meetings planned for December 2025 [3][6] Group 1: Clinical Trial Results - 75% of OST-HER2 treated patients achieved 2-year overall survival, significantly higher than the 40% in historical controls (p < 0.0001) [1][4] - Subgroup analysis indicated that 100% of patients who achieved 12-month Event Free Survival (EFS) also achieved 2-year overall survival [1][4] Group 2: Regulatory Path and Future Plans - The company plans to submit a conditional Marketing Authorization Application (MAA) to the MHRA in December 2025 and a Biologics Licensing Application (BLA) to the FDA in January 2026 [3][6] - OS Therapies is analyzing patient samples to confirm correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025 [3] Group 3: Company Overview and Product Pipeline - OS Therapies focuses on developing treatments for Osteosarcoma and other solid tumors, with OST-HER2 as its lead asset, which has received multiple designations from regulatory agencies [6][7] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [7]

Core Insights - OS Therapies received a positive regulatory update from the European Medicines Agency (EMA) following a meeting with the Dutch Medicines Evaluation Board (MEB) on October 6, 2025, regarding its OST-HER2 Phase 2b clinical trial for osteosarcoma [2][3] Regulatory Developments - The meeting aligned on key areas such as safety, non-clinical data, and chemistry, manufacturing, and controls (CMC) data, supporting the ongoing clinical trial [3][8] - The overall survival results from the trial, showing statistically significant final two-year data, may serve as a primary endpoint for conditional marketing authorization (CMA) [3][8] - A formal EMA Scientific Advice is anticipated in December 2025, establishing a potential pathway for a confirmatory randomized clinical development program [4][10] Clinical Trial Insights - The safety profile from the Fully Resected Osteosarcoma clinical study was confirmed as positive, with data from over 500 patients treated across four other therapeutic indications potentially supporting a CMA [8] - The rapporteur indicated that overall survival (OS) could provide a stronger measure of clinical benefit compared to 12-month Event-Free Survival (EFS) [8] - Efficacy data from other settings, such as recurrent, unresectable pulmonary metastatic osteosarcoma, could be incorporated into a post-market confirmatory clinical development program [8] Market Access and Future Plans - OS Therapies has commenced the Marketing Authorisation Application (MAA) submissions process with the UK MHRA, which has granted an expedited Market Access Scientific Advice Meeting [6] - The company plans to pursue a conditional marketing authorization while advancing a global randomized clinical study to evaluate OST-HER2 in various osteosarcoma clinical settings [10] - OST-HER2 has received multiple designations from the U.S. FDA and EMA, including Rare Pediatric Disease Designation and Fast-Track status [11]

Core Insights - OS Therapies is actively participating in multiple conferences and events in October 2025, showcasing its commitment to advancing cancer treatment and engaging with industry stakeholders [1][2][3][4][5]. Company Overview - OS Therapies Inc. is a clinical-stage biotechnology company focused on developing treatments for Osteosarcoma and other solid tumors, with its lead asset being OST-HER2, an immunotherapy targeting the HER2 protein [5][6]. - OST-HER2 has received several designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, indicating its potential significance in treating rare diseases [5]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, demonstrating statistically significant benefits in the 12-month event-free survival primary endpoint for patients with recurrent, fully resected, lung metastatic osteosarcoma [5]. Upcoming Events - OS Therapies will participate in the Cell and Gene Meeting on the Mesa from October 6-8, 2025, in Phoenix, AZ, focusing on partnering and one-on-one meetings [2]. - The company will also attend the Roth Annual Healthcare Opportunities Conference on October 9, 2025, in New York City, where it will engage in meetings with potential investors [2]. - A workshop on advancing osteosarcoma drug development will take place on October 10, 2025, in Washington, DC, where OS Therapies management will be available for discussions [2]. - The BIOFuture 2025 event is scheduled for October 13-15, 2025, in New York City, featuring a spotlight panel and one-on-one meetings [3]. - The company will be present at the 52nd Daytime Emmy Awards on October 17, 2025, where its documentary "Shelter Me: Cancer Pioneers" has received two nominations [3]. - The Maxim Growth Summit will occur on October 22, 2025, in New York City, where corporate presentations and meetings will be held [4]. - OS Therapies will also participate in BIO - Europe from November 3-5, 2025, in Vienna, Austria, focusing on partnering and meetings [5]. Product Development - OST-HER2 has shown preclinical efficacy in various models of breast cancer and has been conditionally approved by the U.S. Department of Agriculture for treating canines with osteosarcoma [5]. - 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 [6].