OS Therapies Completes $6 Million Private Placement
OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company specializing in cancer immunotherapy and antibody-drug conjugates, today announced the successful completion of a private placement financing, raising approximately $6 million in gross proceeds.
The funds will be used to support the Company’s clinical and regulatory efforts, particularly for advancing the commercialization of its lead therapeutic candidate, OST-HER2, for the treatment of recurrent, resected metastatic osteosarcoma in the United States, with a targeted launch in 2025. Additionally, the Company plans to use the proceeds for general corporate purposes. OST-HER2 has received multiple designations from the US FDA, including rare pediatric disease, fast track, and orphan drug status for osteosarcoma.
OS Therapies, Inc. , a clinical-stage oncology company specializing in cancer immunotherapy, has raised approximately $6 million in gross proceeds through a private placement financing. The funds will support the company’s goal of advancing its lead product candidate, OST-HER2, a targeted immunotherapy for the prevention of recurrent, resected metastatic osteosarcoma.
The financing is expected to enable OS Therapies to operate until 2026, a crucial period during which the company plans to gather the clinical data necessary to obtain Biologics License Application (BLA) approval from the U.S. Food and Drug Administration (FDA). If successful, OST-HER2 will offer a much-needed therapeutic solution for childhood osteosarcoma, a rare and aggressive cancer, and the company expects to begin commercialization by 2025.
Paul Romness, Chairman and CEO of OS Therapies, emphasized that the financing will support the company’s mission of developing OST-HER2 for osteosarcoma, noting that successful approval would not only save lives but could also result in the company receiving a priority review voucher (PRV) valued at approximately $150 million. PRVs are issued to sponsors upon the approval of a drug for rare pediatric diseases, and they can be used to expedite the FDA review process for another product or sold to other companies.
OS Therapies plans to sell the PRV it earns from the approval of OST-HER2 for osteosarcoma. This PRV could further capitalizes OS Therapies, allowing it to expand the clinical development of OST-HER2 into other HER2-positive cancers, including breast and colorectal cancer. The recent sale of a PRV by PTC Therapeutics for $150 million in late November 2024 has highlighted the increasing value of these vouchers, which could further benefit OS Therapies.
In 2021, the FDA granted OST-HER2 rare pediatric disease designation for osteosarcoma. This designation is part of the FDA’s PRV program, which incentivizes the development of treatments for pediatric diseases by offering a priority review voucher upon approval. OS Therapies’ OST-HER2 qualifies for the PRV as it was granted the rare pediatric disease designation prior to December 20, 2024. Even though recent negotiations in the U.S. House of Representatives failed to reauthorize the PRV program for pediatric cancers, OS Therapies remains eligible to receive the voucher as long as OST-HER2 is approved for osteosarcoma before the September 30, 2026 deadline.
In terms of the financing, OS Therapies sold 1.5 million units at $4.00 per unit, with each unit consisting of one share of Series A Senior Convertible Preferred Stock and one warrant to purchase one share of common stock. The preferred stock is convertible into common stock at a price of $4.00 per share, while the warrants have an exercise price of $4.40 per share. Brookline Capital Markets, a division of Arcadia Securities, LLC, served as the placement agent, and Ceros Financial Services, Inc. was engaged as a selected dealer for the offering.
The securities issued in this private placement, along with the common stock into which they may be converted or exercised into, have not been registered under the Securities Act of 1933. As such, these securities cannot be offered or sold in the United States unless registered or unless an exemption applies. OS Therapies has committed to filing a registration statement with the Securities and Exchange Commission (SEC) to register the resale of the common stock underlying the securities sold in the private placement.
About OS Therapies
OS Therapies is a clinical-stage oncology company focused on identifying, developing, and commercializing treatments for osteosarcoma (OS) and other solid tumors. The company’s lead therapeutic candidate, OST-HER2, leverages the immune-stimulatory effects of Listeria bacteria to target the HER2 protein, showing strong preclinical efficacy in breast cancer and osteosarcoma models.
OS Therapies has completed enrollment in a 41-patient Phase 2b clinical trial of OST-HER2 for resected, recurrent osteosarcoma, with results expected by the fourth quarter of 2024. Additionally, OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. The company is also advancing its proprietary tunable ADC (tADC) platform, designed to enable targeted delivery of multiple payloads per antibody-linker combination, providing a versatile approach to treating various cancers.
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