OS Therapies Reports Second Quarter 2025 Financial Results and Provides Business Update
'The Company gained significant momentum in the second quarter as we began to make meaningful clinical and regulatory progress on our path towards bringing the first new treatment for osteosarcoma to market in the United States in the last 40 years,' said Paul Romness, MPH, Chairman & CEO of OS Therapies. 'Now midway through the third quarter, we have updated interim 2-year overall survival data readout that shows a statistically significant benefit for OST-HER2 treated patients, coupled with the final 12-month Event Free Survival ('EFS') that also shows statistically significant benefit for OST-HER2 treated patients, from our Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in recurrent, fully resected, pulmonary metastatic osteosarcoma. The congruence between the overall survival and EFS data gives our clinical and regulatory teams confidence that we are on strong footing as we march towards our goal of receiving a Biologics Licensing Application ('BLA') by the U.S. Food and Drug Administration ('FDA') for OST-HER2 under the Accelerated Approval Program ('Accelerated Approval'). Importantly, our U.S. commercial partnership with Eversana positions us to be able to bring OST-HER2 to osteosarcoma patients in the first half of 2026.'
Mr. Romness continued, 'So long as we receive a BLA for OST-HER2 prior to September 30, 2026, the Company is eligible to be granted a priority review voucher ('PRV'), as a result of OST-HER2's rare pediatric disease designation, that it intends to subsequently sell. Given that the most recent publicly disclosed PRV sale transaction was valued at $160 million in June 2025 versus a May 2025 PRV transaction that was valued at $155 million, we believe that the PRV market is likely to continue to see an increase in value moving forward.'
'Additionally, we have made progress internationally with our recent Innovative Licensing and Access Pathway ('ILAP') submission, which formally begins the regulatory process for OST-HER2 with the United Kingdom's Medicines and Healthcare products Regulatory Agency ('MHRA') following a successful Scientific Advice Meeting ('SAM'), during which we were advised that MHRA recommends a synchronization of the approval process with the FDA via Project Orbis within 30 days of the BLA submission. We have also scheduled an October 2025 rapporteur meeting with the European Medicines Agency ('EMA') as the starting point for the approval process with Europe,' noted Mr. Romness.
Second Quarter 2025 Corporate Highlights:
Third Quarter 2025 Progress to Date and Future Milestones
Progress to Date:
Upcoming 2025 Milestones:
Loss from Operations:
The Company recorded a net operating loss of $4.537 million in the second quarter of 2025, compared with a net operating loss of $1.557 million in the second quarter of 2024. The increase in net loss was largely due to expenses associated with U.S. and international regulatory activities related to the OST-HER2 Phase 2b osteosarcoma program. Net loss per share in the second quarter of 2025 was $0.19 on 25.114 million weighted average shares outstanding, compared to second quarter of 2024 where the Company delivered a net loss of $0.26 per share on 5.991 million weighted average shares outstanding.
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 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 www.ostherapies.com.
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 press 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' in the Company's most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q 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 Relations
Harrison Seidner, PhD
WaterSeid Partners
[email protected]
Public Relations
Stephanie Chen
Elev8 New Media
[email protected]
https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263049
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