Latest news with #OST-HER2
Yahoo
7 days ago
- Business
- Yahoo
OS Therapies Closes $4.2 Million in Warrant Exercise Inducement and Exchange Offer
Cash runway extended through 2026, beyond September 30, 2026 sunset date for rare pediatric priority review voucher (PRV) program Additional funding allows Company to advance strategic alternatives for OS Animal Health, close out OST-504 (previously ADXS-504) prostate cancer study and initiate AI-driven next-gen tADC product candidate modeling New York, New York--(Newsfile Corp. - July 14, 2025) - OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has closed its previously announced warrant exercise inducement and exchange offer. The Company raised a total of $4.2 million in gross proceeds from the offering. The Company intends to use the net proceeds primarily to support U.S. and international regulatory and pre-commercial efforts aimed at securing accelerated marketing authorizations for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. Additionally, to develop further, advance strategic alternatives for its OS Animal Health subsidiary, close out and report on its OST-504 (previously ADXS-504) prostate cancer study, initiate artificial intelligence (AI)-driven next-gen tADC product candidate modeling and for general corporate purposes. The terms of the warrant exercise inducement and exchange offer are described in greater detail in the Company's Current Report on Form 8-K filed with the SEC on July 14, 2025. "The success of this warrant exercise inducement and exchange offer provides us with capital runway through 2026," said Paul Romness, Chairman and CEO of OS Therapies. "In the next 18 months, we intend to pursue a Biologics Licensing Authorization under the Accelerated Approval Program for OST-HER2 in human osteosarcoma that we anticipate yielding a highly valuable and saleable Priority Review Voucher ("PRV"). We plan to complete evaluation of strategic alternatives for our OST-HER2 canine osteosarcoma program under our wholly owned OS Animal Health subsidiary, and report a final data readout for our OST-504 prostate cancer program. We also intend to initiate an AI-driven product candidate modeling exercise for our tunable ADC program to create new classes of next generation therapeutic candidates that address multiple complementary mechanisms across solid tumors leveraging our unique SiLinkers™ platform." Mr. Romness continued, "We remain focused on our regulatory plan: End of Phase 2 Meeting with the FDA in the United States and our Scientific Advice Meetings in the United Kingdom and Europe. This delivers on our core mission of improving the treatment landscape for metastatic osteosarcoma patients. We are cognizant that we have significant value in our pipeline programs that we can now begin to evaluate more thoroughly while minimizing cash spend. With the breadth of the technologies we have assembled, we are poised to begin improving the cancer therapeutic landscape in the years ahead." This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) 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 reported 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 Biologics Licensing Application (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 StatementsStatements 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. This information concerns product candidates that are under clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA). These product candidates are currently limited by Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. 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 FDA and other risks and uncertainties described under the heading "Risk Factors" 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. OS Therapies Contact Information: Investor RelationsHarrison Seidner, PhDWaterSeid PartnersOSTX@ Public RelationsStephanie ChenElev8 New Mediastephanie@ To view the source version of this press release, please visit Sign in to access your portfolio
Business Wire
03-07-2025
- Business
- Business Wire
OS Therapies Granted End of Phase 2 Meeting by US FDA for OST-HER2 Program in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
NEW YORK--(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 it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration ('FDA') to review the OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. The Company expects the meeting to occur in the third quarter of 2025. The End of Phase 2 Meeting marks a pivotal point in the drug development process, and a significant milestone towards market access. The Company intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming Biologics Licensing Application ('BLA') submission for OST-HER2. The Rolling Review process means that a company can submit completed sections of its Biologic License Application (BLA) for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. This can contribute to augmented interactions with FDA and potentially an expedited BLA approval timeline. OST-HER2 has received FDA Orphan Disease Designation (ODD), Fast Track and Rare Pediatric Disease Designation (RPDD) from FDA. Under the RPDD program, if the Company receives Accelerated Approval prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent PRV sale, valued at $160 million, occurred in June 2025. OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie 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 trailer is available here and the movie is available via streaming on PBS' website. The most recent data regarding the OST-HER2 canine osteosarcoma program is available at this link. The Company has formed subsidiary OS Animal Health to advance the canine osteosarcoma program. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) 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 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 Biologics Licensing Application (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.
Business Wire
30-06-2025
- Business
- Business Wire
OS Therapies Presents Statistically Significantly Positive 1-Year Event Free Survival, Overall Survival and Safety Clinical Data Updates for OST-HER2 at the MIB Agents Factor Osteosarcoma Conference
NEW YORK--(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 positive 1-year event free survival (EFS), overall survival and safety clinical trial data updates from the 40 patient treatment arm of its Phase 2b clinical trial of immunotherapy candidate OST-HER2 in the prevention or delay of recurrence in fully resected, lung metastatic osteosarcoma. In data presented by Principal Investigator Dr. Damon Reed at the MIB Factor Osteosarcoma Conference held in Salt Lake City, Utah on Saturday June 28, 2025 the following data updates were released: 35% (14 out of 40) of OST-HER2-treated patients achieved 1-year event free survival (EFS) compared with 20% of patients from peer-reviewed publication selected by Children's Oncology Group (COG) 1 as equivalent to osteosarcoma patient subpopulation enrolled (p = 0.0194); A total of 13 out of 40 patients were reported to have experienced severe adverse events (SAEs) during the trial, of which 7 patients' adverse events were treatment-associated adverse events (TSAEs). All of the 7 patients' TSAEs were grade 3 TSAEs; 0 patients experienced grade 4 or grade 5 TSAEs. None of the patients for whom TSAEs were reported discontinued the study. 'The updated OST-HER2 data presented at MIB Factor that showed EFS data statistically significantly favoring OST-HER2 treated patients when compared with the leading peer-reviewed publications on historical event free survival outcomes in this subset of the pulmonary metastatic osteosarcoma patient population,' said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. 'The favorable safety profile of OST-HER2 compared with standard of care is also an important quality of life factor when assessing potential new treatment options for this difficult to treat patient population.' Additionally, the Company today announced a regulatory update regarding the submission of preliminary external control data and comprehensive plans for the finalization of this data package to the US Food & Drug Administration's ('FDA'). In accordance with the provisions of prevailing Guidance to Industry – including ICH E10 Choice of Control Group in Clinical Trials; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products 2019; and Rare Diseases – Natural History Studies for Drug Development 2019 - to support a Biologics Licensing Application (BLA) marketing authorization under the US Food & Drug Administration's ('FDA') Accelerated Approval Program ('Accelerated Approval'). Based on guidance from FDA from its recent Type D Meeting and the submission of subsequent responses to FDA arising from the Meeting, the Company is providing updated superiority peer-reviewed historical external control data, matched external control data and/or real-world external control data. This data, individually or collectively at FDA's discretion, may be sufficient for FDA to support a marketing authorization in a setting where randomization may not be feasible. Such an approach is common in rare diseases – such as Prevention or Delay of Recurrence in Fully Resected, Lung Metastatic Osteosarcoma - for which the company holds US FDA Orphan Disease Designation (ODD), Fast Track and Rare Pediatric Disease Designation (RPDD). The Company has submitted clarifying information to FDA Type D Meeting feedback requests regarding proposed statistical methods to be used in FDA's assessment of external control arm(s) suitable to support Accelerated Approval. The Company is awaiting response from FDA to its End of Phase 2 meeting request where, if granted, the Company will seek full alignment on the individual and/or collective data sets necessary to support Accelerated Approval. The Company has collected multiple sources of potential case matched external control and real-world data potentially suitable, individually or together with historical external control data at FDA's discretion, to support Accelerated Approval. 'The feedback received from FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible increases the avenues available for OST-HER to gain Accelerated Approval,' said Paul Romness, Chairman & CEO of OS Therapies. 'We have now responded to the follow-up questions from our recent positive Type D Meeting with FDA positioning us to soon be granted an End of Phase 2 meeting. We were also very pleased with the reception the presentation received from the osteosarcoma community.' Mr. Romness continued: 'Recent interactions we have had with FDA are consistent with public statements from FDA leadership prioritizing the safety profile of potential new products under consideration for Accelerated Approval that are intended to treat deadly rare diseases where randomized trials may not be feasible, especially in pediatric cancer where no alternative treatment options are approved.' Concurrent with this announcement, the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to support the Company in utilizing its Clinical Practice Research Datalink (CRPD) to assist the Company in developing data necessary to support potential worldwide marketing authorizations – including in the UK, US and EU - for OST-HER2. The CPRD collects anonymized patient data from a network of healthcare practitioners and institutions across the UK. Primary care data are linked to a range of other health related data to provide a longitudinal, representative population health dataset. The data encompass 60 million patients, including 18 million currently registered patients. Follow-up from the Company's July 31 st, 2025 Scientific Advice Meeting with MHRA is expected by mid-August 2025. ( OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA. If the Company receives Accelerated Approval prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent PRV sale, valued at $160 million, occurred in June 2025. OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie 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 PBS' website. The most recent data updated regarding the OST-HER2 canine osteosarcoma program is available at this link. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) 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 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 Biologics Licensing Application (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.
Business Wire
24-06-2025
- Business
- Business Wire
OS Therapies Receives Positive FDA Meeting Feedback on Regulatory Pathway for Accelerated Approval of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma
NEW YORK--(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 that it received positive written feedback from the US Food & Drug Administration ('FDA') Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma. The Company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28, 2025 at 3:30pm MDT. Concurrent with this announcement, the Company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company's overall regulatory strategy and timelines. 'We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ,' said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. 'Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA's current position and allows us to be fully prepared for the End of Phase 2 Meeting.' OST-HER2 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 occurred in June 2025, valued at $160 million. The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million. OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie 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 PBS' website. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) 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 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 Biologics Licensing Application (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
24-06-2025
- Business
- Yahoo
OS Therapies Receives Positive FDA Meeting Feedback on Regulatory Pathway for Accelerated Approval of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma
Company has requested End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) based upon the positive FDA Meeting feedback NEW YORK, June 24, 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 that it received positive written feedback from the US Food & Drug Administration ("FDA") Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma. The Company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28, 2025 at 3:30pm MDT. Concurrent with this announcement, the Company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company's overall regulatory strategy and timelines. "We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA's current position and allows us to be fully prepared for the End of Phase 2 Meeting." OST-HER2 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 occurred in June 2025, valued at $160 million. The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million. OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie 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 PBS' website. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) 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 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 Biologics Licensing Application (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 Doll410-297-7793Irpr@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
