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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
Business Wire
15-05-2025
- Business
- Business Wire
OS Therapies Forms Subsidiary OS Animal Health to Commercialize OST-HER2 for Canine 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 the launch of OS Animal Health, Inc., a wholly owned subsidiary focused on commercializing OST-HER2 for the treatment of canine 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.
Yahoo
28-02-2025
- Business
- Yahoo
Calidi Biotherapeutics and OS Therapies Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
ORLANDO, FLORIDA / / February 28, 2025 / RedChip Companies will air interviews with Calidi Biotherapeutics, Inc. (NYSE American:CLDI) and OS Therapies Inc. (NYSE American:OSTX) on the RedChip Small Stocks, Big Money™ show, a sponsored program on Bloomberg TV this Saturday, March 1, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S. Access the interviews in their entirety at: CLDI: OSTX: In an exclusive interview, Andrew Jackson, CFO of Calidi Biotherapeutics, appears on the RedChip Small Stocks Big Money™ show on Bloomberg TV to discuss the company's innovative approach to transforming cancer treatment through its proprietary oncolytic virotherapy (OV) platforms. Jackson highlights Calidi's novel stem cell-based technology, designed to protect, amplify, and potentiate oncolytic viruses, enabling a more effective and targeted attack on cancer cells. He provides insights into Calidi's robust clinical pipeline, including CLD-101, currently in a Phase 1/1b trial with an upcoming Phase 1b/2 study, and CLD-201, targeting Phase 1 initiation in 2025. Additionally, Jackson outlines the company's significant market opportunity, with an addressable U.S. market estimated at $13 billion to $15 billion. With early clinical signals demonstrating efficacy and safety, and a leadership team experienced in building successful biotech companies, Calidi is well-positioned to advance next-generation cancer therapies and drive long-term value for investors. Paul Romness, CEO of OS Therapies, appears on the RedChip Small Stocks Big Money™ show on Bloomberg TV to discuss the company's innovative approach to treating osteosarcoma (OS) and other solid tumors. Romness highlights OS Therapies' lead candidate, OST-HER2, a groundbreaking immunotherapy leveraging a bioengineered Listeria monocytogenes strain to trigger a targeted immune response against HER2-positive cancers. With statistically significant improvements in 12-month event-free survival for recurrent, fully resected metastatic OS, OST-HER2 is positioned for accelerated FDA approval, benefiting from Rare Pediatric Disease, Orphan Drug, and Fast Track designations. Romness also details OS Therapies' next-generation Tunable Antibody Drug Conjugate (tADC) platform, which utilizes proprietary SiLinker™ technology to deliver precision-targeted cancer treatments. With large market opportunities in osteosarcoma and HER2-positive solid tumors, and a strong leadership team driving regulatory and commercialization strategies, OS Therapies is well-positioned to advance novel oncology treatments and create significant value for investors. CLDI and OSTX are clients of RedChip Companies. Please read our full disclosure at About Calidi Biotherapeutics Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi's novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi's clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi's preclinical off-the-shelf enveloped virotherapies, are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit 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, fast-track and orphan drug designations from the USFDA. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, with positive results released in the first quarter of 2025. 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) platform, known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit About RedChip Companies RedChip Companies, an Inc. 5000 company, is an international investor relations, media, and research firm focused on microcap and small-cap companies. For 33 years, RedChip has delivered concrete, measurable results for its clients. Our newsletter, Small Stocks, Big Money™, is delivered online weekly to 60,000 investors. RedChip has developed the most comprehensive service platform in the industry for microcap and small-cap companies. These services include the following: a worldwide distribution network for its stock research; retail and institutional roadshows in major U.S. cities; outbound marketing to stock brokers, RIAs, institutions, and family offices; a digital media investor relations platform that has generated millions of unique investor views; investor webinars and group calls; a television show, Small Stocks, Big Money™, which airs weekly on Bloomberg US; TV commercials in local and national markets; corporate and product videos; website design; and traditional investor relation services, which include press release writing, development of investor presentations, quarterly conference call script writing, strategic consulting, capital raising, and more. To learn more about RedChip's products and services, please visit: "Discovering Tomorrow's Blue Chips Today"™ Follow RedChip on LinkedIn: Follow RedChip on Facebook: Follow RedChip on Instagram: Follow RedChip on Twitter: Follow RedChip on YouTube: Follow RedChip on Rumble: Subscribe to our Mailing List: Contact: Dave GentryRedChip Companies Inc.1-407-644-4256info@ --END-- SOURCE: RedChip View the original press release on ACCESS Newswire
