Full Press Release Details
OS Therapies Reports
First Quarter 2025 Financial Results and Provides Business Update
May 16, 2025 - 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,"
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, and extended the exclusivity protection for its commercial
runway into 2040 with the issuance of a new manufacturing patent. Moreover, we 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, and will begin more substantially engaging with the osteosarcoma community for its
support in the 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:
Second Quarter 2025 Progress to Date and Future
Upcoming 2025 Milestones:
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.
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 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 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.
OS Therapies Contact Information: