Full Press Release Details
Therapies Reports Second Quarter 2024 Financial Results
MD, August 15, 2024 - OS Therapies, Inc. (NYSE: OSTX) ("OS Therapies" or "the Company"),
an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today reported financial results for the second quarter
of 2024 ended June 30, 2024.
As of the date of our successful initial public
offering (IPO) that occurred on July 31, 2024 on the NYSE American stock exchange, the Company successfully converted all of its outstanding
preferred shares and debt into equity, raising $6.4 million in gross proceeds that provides the Company with cash runway through mid-2025,
and received the support from the vast majority of its shareholders who signed 6-month underwriter lockup agreements, crucially through
the fourth quarter 2024 readout of the fully-enrolled human Phase 2b clinical trial in resected, recurrent osteosarcoma, allowing the
IPO to occur without the issuance of any warrants. The Company now has sufficient capital to meet the key objectives for its lead program
OST-HER2, including the completion of the Phase 2b human osteosarcoma trial, as well as the completion of a pivotal safety study that
would allow for the conditional approval already received by the US Department of Agriculture for OST-HER2 in canine osteosarcoma to be
converted into a full approval, paving the way for commercialization nationwide. There are approximately 1,000 new human osteosarcoma
diagnoses over 10,000 canine osteosarcoma diagnoses reported annually in the United States.
Second Quarter Corporate
Subsequent Event Highlights:
Highlights for the Second Quarter:
The Company is a pre-revenue biotechnology
company. The Company anticipates beginning to generate revenue through the sale of licensing rights to its products and product candidates
as they achieve upcoming de-risking clinical and regulatory milestones.
Loss from Operations:
The Company recorded a net operating loss
of $1.557 million in the second quarter of 2024 compared to an operating loss of $2.505 million in the second quarter of 2023. The decrease
in net loss was largely due to the majority of patients enrolled in the Phase 2b OST-HER2 clinical trial having completed the 1-year treatment
phase and moving into the observation only phase evaluating overall survival. Net loss per share in the second quarter of 2024 was $0.26
on 5.991 million weighted average shares outstanding compared to the second quarter of 2023 where the Company delivered a loss of $0.47
per share on 5.340 million weighted average shares outstanding.
OS Therapies' pipeline lead OST-HER2
is a Lm vector-based off-the-shelf Immunotherapy intended to prevent metastasis, delay recurrence, and increase overall survival.
The Company has screened/enrolled 54 and dosed 41 patients per protocol of its AOST-2121 Phase 2b clinical trial in recurred, resected
osteosarcoma testing OST-HER2 (Listeria monocytogenes). There are 21 clinical trial sites open across the United States. OST-HER2
has received Rare Pediatric Disease Designation (RPDD) from the FDA and Fast Track and Orphan Drug Designations from the FDA and European
Medicines Agency (EMA). OS Therapies is seeking Breakthrough Therapy Designation for OST-HER2 for osteosarcoma from the FDA based on data
from its Phase IIb clinical trial. Upon any BLA from the FDA for OST-HER2 in osteosarcoma, the Company will be granted a Priority Review
Voucher based upon the RPDD. In 2023, the US FDA approved 28 drugs and 12 biologics for the treatment of orphan diseases.
OST-HER2 has completed a Phase 1 clinical
trial, primarily in breast cancer patients, in addition to strong preclinical data demonstrating efficacy on a standalone basis and in
combination with HER2-targeting therapeutic antibodies such as Herceptin . The Company intends to pursue therapeutic development of
OST-HER2 in breast cancer following FDA approval for OST-HER2 in osteosarcoma.
This press release shall not constitute an
offer to sell or the solicitation of an offer to buy any securities.
For more information, please see the Company's
website at www.ostherapies.com
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. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in resected,
recurrent osteosarcoma, with results expected in the fourth quarter of 2024. OST-HER2 has completed a Phase 1 clinical study primarily
in breast cancer patients, in addition to showing strong preclinical efficacy data in various models of breast cancer. 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 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. OS Therapies' drug development
efforts, clinical trial results, patient enrollments, FDA regulatory approvals, designations, and intellectual property protections. Prospective
investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties,
including those described under the caption "Risk Factors" and elsewhere in the prospectus filed with the SEC relating to the
offering and that actual results may differ materially from those indicated by such forward-looking statements. 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
Corporate and Media Contact:
RedChip Companies, Inc.