Latest news with #OST-HER2
Business Wire
2 days ago
- Business
- Business Wire
OS Therapies Submits Request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the Prevention of Metastases in Recurrent, Fully-Resected, Lung Metastatic Pediatric Osteosarcoma
NEW YORK--(BUSINESS WIRE)-- OS Therapies Inc. (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced it has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. RMAT designations are granted to sponsors with regenerative medicine therapies for serious or life-threatening conditions and provide sponsors with various benefits, including eligibility for an accelerated Biologics License Application (BLA) review. OST-HER2 has already received Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for osteosarcoma from the U.S. FDA. If OST-HER2 receives a conditional BLA via Accelerated Review prior to September 30, 2026, the Company will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent publicly disclosed PRV sale, valued at $155 million, occurred in May 2025. The Company is awaiting feedback by mid-June 2025 from a Type D meeting with FDA regarding the statistical analysis plan to be used in an End of Phase 2 meeting for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. Upon receipt of the Type D Meeting feedback, the Company intends to promptly request the End of Phase 2 meeting with FDA in which it will be seek agreement to allow it to begin a rolling BLA submission in the third quarter of 2025. The grant of the RMAT designation in the third quarter of 2025 complements the company's parallel efforts in other major markets, including Europe and the United Kingdom, where the company plans to seek EMA PRIME Designation and Conditional Market Access (CMA) applications. In parallel to regulatory engagement and market access planning for OST-HER2, the Company is preparing for the late stage clinical development of other pipeline candidates. As such, the Company is well positioned for sustained growth across multiple therapeutic modalities. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. 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 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and Fast-Track and Orphan Drug designations from the U.S. FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the U.S. FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the U.S. FDA and other risks and uncertainties described in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Yahoo
2 days ago
- Business
- Yahoo
OS Therapies Submits Request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the Prevention of Metastases in Recurrent, Fully-Resected, Lung Metastatic Pediatric Osteosarcoma
If awarded, OST-HER2 would become the first listeria investigational medicinal product to be awarded the RMAT designation RMAT designation reduces BLA application review time and permits augmented interactions with FDA to inform market access NEW YORK, June 06, 2025--(BUSINESS WIRE)--OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced it has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. RMAT designations are granted to sponsors with regenerative medicine therapies for serious or life-threatening conditions and provide sponsors with various benefits, including eligibility for an accelerated Biologics License Application (BLA) review. OST-HER2 has already received Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for osteosarcoma from the U.S. FDA. If OST-HER2 receives a conditional BLA via Accelerated Review prior to September 30, 2026, the Company will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent publicly disclosed PRV sale, valued at $155 million, occurred in May 2025. The Company is awaiting feedback by mid-June 2025 from a Type D meeting with FDA regarding the statistical analysis plan to be used in an End of Phase 2 meeting for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. Upon receipt of the Type D Meeting feedback, the Company intends to promptly request the End of Phase 2 meeting with FDA in which it will be seek agreement to allow it to begin a rolling BLA submission in the third quarter of 2025. The grant of the RMAT designation in the third quarter of 2025 complements the company's parallel efforts in other major markets, including Europe and the United Kingdom, where the company plans to seek EMA PRIME Designation and Conditional Market Access (CMA) applications. In parallel to regulatory engagement and market access planning for OST-HER2, the Company is preparing for the late stage clinical development of other pipeline candidates. As such, the Company is well positioned for sustained growth across multiple therapeutic modalities. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. 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 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and Fast-Track and Orphan Drug designations from the U.S. FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the U.S. FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the U.S. FDA and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. View source version on Contacts OS Therapies Contact Information: Jack Doll410-297-7793Irpr@
Yahoo
16-05-2025
- Business
- Yahoo
OS Therapies Reports First Quarter 2025 Financial Results and Provides Business Update
Feedback from Type D FDA Meeting expected by mid-June 2025 to confirm statistical analysis methods to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy & Breakthrough Therapy designation requests Completed Phase 2b trial data analysis using methods agreed to by FDA to be presented at MIB Factor on June 28, 2025 Company remains on track for Q3 2025 BLA filing for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma NEW YORK, May 16, 2025--(BUSINESS WIRE)--OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported first quarter 2025 financial results ended March 31, 2025 and provided a business update. "The first quarter of 2025 was a crucial execution quarter for OS Therapies, as we announced positive data from our OST-HER2 Phase 2b clinical trial in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma and will be leveraging this data to seek Accelerated Approval from the FDA and other regulatory authorities," said Paul Romness, MHP, Chairman & CEO of OS Therapies. "Additionally, we consolidated ownership of the listeria immunotherapy platform, adding three clinical stage and eight preclinical assets to our pipeline. We extended the exclusivity protection for its commercial runway into 2040 with the issuance of a new manufacturing patent. Additionally, we have secured research coverage from Wall Street analysts who have shown significant interest in the revival of the listeria immunotherapy platform. We have started important interactions with the FDA with a view towards an Accelerated Approval, with the Osteosarcoma community supporting in the ongoing FDA process. We believe we are well positioned to bring the first new treatment for osteosarcoma to market in over 40 years." "As outlined in communications surrounding our 2024 Annual Report on Form 10-K, the first quarter saw some significant one-time expenses related to closing out the treatment phase of the Phase 2b trial, as well as start-up costs for regulatory preparations ahead of our submission," said Chris Acevedo, Chief Financial Officer of OS Therapies. "Those one-time expenses are now largely behind us, and we have dramatically reduced our burn rate, positioning us to operate into mid-2026." First Quarter 2025 Corporate Highlights: Reported positive data for our Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma, a rare pediatric indication Announced agreement to acquire three clinical stage, eight preclinical stage and all intellectual property surrounding the listeria cancer immunotherapy platform from Ayala Pharmaceuticals Initiated manufacturing protocols to support the commercial launch of OST-HER2 Received a Notice of Allowance from the US Patent & Trademark Office related to the pending issuance of a patent protecting a new commercial manufacturing process for the listeria cancer immunotherapy platform into 2040 Formed subsidiary OS Drug Conjugates (OSDC) to create a focused business development opportunity for the Company's proprietary pH-sensitive tunable Antibody Drug Conjugates and tunable Drug Conjugates platform Secured a Scientific Advice Meeting with the UK Medicines and Healthcare products Regulatory Agency to discuss seeking approval in the UK for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma Received the keynote presentation at the osteosarcoma community's leading conference MIB Factor for June 28, 2025 in Salt Lake City, Utah Second Quarter 2025 Progress to Date and Future Milestones Progress to Date: Secured a Type D meeting with the FDA to gain alignment on the statistical analysis plan for the OST-HER2 trial needed to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy and Breakthrough Therapy designation requests Completed the acquisition of the listeria cancer immunotherapy clinical, preclinical and IP assets from Ayala Pharmaceuticals Announced positive data from canine osteosarcoma trials expanding the potential use of OST-HER2 into the prevention of amputation and control of lung metastases Reported the formal issuance of the patent protecting proprietary commercial manufacturing methods for the listeria cancer immunotherapy platform Formed subsidiary OS Animal Health to focus on commercialization of OST-HER2 in canine osteosarcoma Upcoming 2025 Milestones: Feedback from Type D meeting with the FDA on the proposed statistical analysis plan of the OST-HER2 osteosarcoma program that will be used to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy and Breakthrough Therapy designation requests on or before June 16, 2025 Presentation of the OST-HER2 Phase 2b osteosarcoma program data analyzed based upon FDA feedback at MIB Factor on June 28, 2025 End of Phase 2 Meeting with FDA in Q3 2025 to review OST-HER2 Phase 2b osteosarcoma program data Projected BLA submission in Q3 2025 for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma Summer 2025 Scientific Advice Meeting (SAM) with MHRA for OST-HER2 osteosarcoma program, ILAP application submission and MHRA Conditional Marketing Authorisation application & decision EMA National Competent Authority Scientific Advice Meeting Request (Medicines Evaluation Board, Netherlands) for OST-HER2 osteosarcoma program, EMA PRIME, EMA-FDA Parallel Scientific Advice application and EMA Conditional Marketing Authorisation application & decision USDA meeting for OST-HER2 canine osteosarcoma program, conditional approval and initiation of pivotal clinical studies in preventive and therapeutic applications of OST-HER2 in osteosarcoma via subsidiary OS Animal Health Loss from Operations: The Company recorded a net operating loss of $3.876 million in the first quarter of 2025 compared with a net operating loss of $1.490 million in the first quarter of 2024. The increase in net loss was largely due to expenses associated with closing of the OST-HER2 Phase 2b osteosarcoma trial and expenses associated with initiating regulatory affairs activities associated with seeking Accelerated Approval with US FDA for OST-HER2 in osteosarcoma. Net loss per share in the first quarter of 2025 was $0.18 on 21.249 million weighted average shares outstanding compared to first quarter of 2024 where the Company delivered a loss of $0.25 per share on 5.991 million weighted average shares outstanding. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. 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 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. View source version on Contacts OS Therapies Contact Information:Jack Doll+1-410-297-7793Irpr@ Sign in to access your portfolio
Business Wire
16-05-2025
- Business
- Business Wire
OS Therapies Reports First Quarter 2025 Financial Results and Provides Business Update
NEW YORK--(BUSINESS WIRE)-- OS Therapies Inc. (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported first quarter 2025 financial results ended March 31, 2025 and provided a business update. 'The first quarter of 2025 was a crucial execution quarter for OS Therapies, as we announced positive data from our OST-HER2 Phase 2b clinical trial in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma and will be leveraging this data to seek Accelerated Approval from the FDA and other regulatory authorities,' said Paul Romness, MHP, Chairman & CEO of OS Therapies. 'Additionally, we consolidated ownership of the listeria immunotherapy platform, adding three clinical stage and eight preclinical assets to our pipeline. We extended the exclusivity protection for its commercial runway into 2040 with the issuance of a new manufacturing patent. Additionally, we have secured research coverage from Wall Street analysts who have shown significant interest in the revival of the listeria immunotherapy platform. We have started important interactions with the FDA with a view towards an Accelerated Approval, with the Osteosarcoma community supporting in the ongoing FDA process. We believe we are well positioned to bring the first new treatment for osteosarcoma to market in over 40 years.' 'As outlined in communications surrounding our 2024 Annual Report on Form 10-K, the first quarter saw some significant one-time expenses related to closing out the treatment phase of the Phase 2b trial, as well as start-up costs for regulatory preparations ahead of our submission,' said Chris Acevedo, Chief Financial Officer of OS Therapies. 'Those one-time expenses are now largely behind us, and we have dramatically reduced our burn rate, positioning us to operate into mid-2026.' First Quarter 2025 Corporate Highlights: Reported positive data for our Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma, a rare pediatric indication Announced agreement to acquire three clinical stage, eight preclinical stage and all intellectual property surrounding the listeria cancer immunotherapy platform from Ayala Pharmaceuticals Initiated manufacturing protocols to support the commercial launch of OST-HER2 Received a Notice of Allowance from the US Patent & Trademark Office related to the pending issuance of a patent protecting a new commercial manufacturing process for the listeria cancer immunotherapy platform into 2040 Formed subsidiary OS Drug Conjugates (OSDC) to create a focused business development opportunity for the Company's proprietary pH-sensitive tunable Antibody Drug Conjugates and tunable Drug Conjugates platform Secured a Scientific Advice Meeting with the UK Medicines and Healthcare products Regulatory Agency to discuss seeking approval in the UK for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma Received the keynote presentation at the osteosarcoma community's leading conference MIB Factor for June 28, 2025 in Salt Lake City, Utah Second Quarter 2025 Progress to Date and Future Milestones Progress to Date: Secured a Type D meeting with the FDA to gain alignment on the statistical analysis plan for the OST-HER2 trial needed to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy and Breakthrough Therapy designation requests Completed the acquisition of the listeria cancer immunotherapy clinical, preclinical and IP assets from Ayala Pharmaceuticals Announced positive data from canine osteosarcoma trials expanding the potential use of OST-HER2 into the prevention of amputation and control of lung metastases Reported the formal issuance of the patent protecting proprietary commercial manufacturing methods for the listeria cancer immunotherapy platform Formed subsidiary OS Animal Health to focus on commercialization of OST-HER2 in canine osteosarcoma Upcoming 2025 Milestones: Feedback from Type D meeting with the FDA on the proposed statistical analysis plan of the OST-HER2 osteosarcoma program that will be used to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy and Breakthrough Therapy designation requests on or before June 16, 2025 Presentation of the OST-HER2 Phase 2b osteosarcoma program data analyzed based upon FDA feedback at MIB Factor on June 28, 2025 End of Phase 2 Meeting with FDA in Q3 2025 to review OST-HER2 Phase 2b osteosarcoma program data Projected BLA submission in Q3 2025 for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma Summer 2025 Scientific Advice Meeting (SAM) with MHRA for OST-HER2 osteosarcoma program, ILAP application submission and MHRA Conditional Marketing Authorisation application & decision EMA National Competent Authority Scientific Advice Meeting Request (Medicines Evaluation Board, Netherlands) for OST-HER2 osteosarcoma program, EMA PRIME, EMA-FDA Parallel Scientific Advice application and EMA Conditional Marketing Authorisation application & decision USDA meeting for OST-HER2 canine osteosarcoma program, conditional approval and initiation of pivotal clinical studies in preventive and therapeutic applications of OST-HER2 in osteosarcoma via subsidiary OS Animal Health Loss from Operations: The Company recorded a net operating loss of $3.876 million in the first quarter of 2025 compared with a net operating loss of $1.490 million in the first quarter of 2024. The increase in net loss was largely due to expenses associated with closing of the OST-HER2 Phase 2b osteosarcoma trial and expenses associated with initiating regulatory affairs activities associated with seeking Accelerated Approval with US FDA for OST-HER2 in osteosarcoma. Net loss per share in the first quarter of 2025 was $0.18 on 21.249 million weighted average shares outstanding compared to first quarter of 2024 where the Company delivered a loss of $0.25 per share on 5.991 million weighted average shares outstanding. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. 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 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and other risks and uncertainties described in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Yahoo
15-05-2025
- Business
- Yahoo
OS Therapies Forms Subsidiary OS Animal Health to Commercialize OST-HER2 for Canine Osteosarcoma
NEW YORK, May 15, 2025--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the launch of OS Animal Health, Inc., a wholly owned subsidiary focused on commercializing OST-HER2 for the treatment of canine osteosarcoma. OST-HER2 market opportunity in canine osteosarcoma exceeds $150 million Recent data in prevention of amputation in frontline canine osteosarcoma and control of metastatic osteosarcoma adds to historical data that supported prior conditional approval related to increase in overall survival (OS) post-amputation Updated commercial manufacturing process to be used in pending new USDA conditional approval application for frontline, metastatic and OS in osteosarcoma OST-HER2 is an off-the-shelf immunotherapy candidate that has shown positive clinical data in both human pediatric and canine osteosarcoma. Parent company OS Therapies is advancing towards an FDA Accelerated Approval submission, anticipated in the third quarter of 2025, for the prevention of recurrence in pediatric patients with fully resected, lung-metastatic osteosarcoma. Concurrently, its wholly-owned subsidiary, OS Animal Health, is focused on re-establishing USDA conditional approval for OST-HER2 in canine osteosarcoma, with a targeted submission in the second half of 2025. "Osteosarcoma is the most common canine cancer, affecting more than 40,000 dogs in the U.S. each year," said Paul Romness, CEO of OS Therapies. "Given the recent issuance of a new patent protecting the commercial manufacturing process for OST-HER2 and the rest of our listeria immunotherapy platform into 2040, we now have a clear commercial opportunity to greatly improve health outcomes in this deadly canine cancer through OS Animal Health." To advance OST-HER2 in the veterinary space with the attention it deserves, OS Animal Health will operate independently from the parent company, with separate funding aligned to the needs of the animal health market. "Selling into the animal health cancer market is substantially different than selling into the human cancer market, and as such we have created this new corporate structure that will be capitalized separately and independently from the parent company's balance sheet so that we can deliver on this unique market opportunity without diluting OS Therapies share structure," Mr. Romness added. "Our current animal health advisors are providing the clinical and regulatory expertise we need to move the USDA process forward. We expect OS Animal Health to begin generating revenue as early as 2025." According to Grandview Research, the veterinary oncology market is valued at 1.57 billion, with canine osteosarcoma representing 86% of the total – approximately $1.35 billion. OS Therapies estimates OST-HER2's addressable opportunity in U.S. canine osteosarcoma to be over $150 million. The canine osteosarcoma treatment market is currently dominated by chemotherapy, radiation therapy, and surgical procedures such as amputation and tumor resection – approaches that often result in limited overall survival outcomes. OST-HER2 has the potential to significantly improve how this aggressive cancer is treated in dogs, offering a less invasive and more targeted alternative to current options. OST-HER2 is also featured in the PBS documentary Shelter Me: The Cancer Pioneers, which offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The movie is available via streaming on the PBS website. OST-HER2, being developed by parent company OS Therapies, Inc. for pediatric osteosarcoma, has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, valued at $155 million, occurred in May 2025. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. 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 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's registration statement on Form S-1 filed with the Securities and Exchange Commission (the "SEC") on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. View source version on Contacts OS Therapies Contact Information: Jack Doll571.243.9455Irpr@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
