OS Therapies Reports $8.9 Million Net Loss for 2024, Highlights IPO Success and Clinical Trial Progress

OS Therapies Incorporated, a clinical-stage biopharmaceutical company focused on developing treatments for Osteosarcoma and other solid tumors, reported a net loss of approximately $8.9 million for the year ended December 31, 2024, compared to a net loss of $7.8 million in 2023. The company's total operating expenses increased to $6.8 million from $4.3 million in the previous year, primarily driven by a significant rise in general and administrative expenses, which rose to $4.0 million from $1.1 million. Research and development expenses decreased slightly to $2.8 million from $3.2 million, reflecting reduced vendor expenses associated with the OST-tADC product.

In terms of financial position, OS Therapies reported cash reserves of approximately $5.5 million as of December 31, 2024, a substantial increase from $39,000 at the end of 2023. This increase was largely attributed to the company's initial public offering (IPO) in August 2024, which raised $6.4 million, and a subsequent private placement that generated approximately $7.1 million in gross proceeds. The company has indicated that these funds will support its ongoing operations and development activities for the next nine to twelve months.

Strategically, OS Therapies is advancing its lead product candidate, OST-HER2, which is currently in a Phase IIb clinical trial for Osteosarcoma. The trial, which enrolled 41 patients, is expected to yield topline results by the fourth quarter of 2024. The company plans to seek regulatory approval for OST-HER2 in 2025, with intentions to expand its use into other solid tumors such as breast, esophageal, and lung cancers. Additionally, OS Therapies has entered into an Asset Purchase Agreement with Ayala Pharmaceuticals to acquire HER2-related assets, which includes investigational new drug filings for non-small cell lung cancer and prostate cancer.

Operationally, OS Therapies has maintained a small workforce, with four full-time employees and one part-time employee as of March 2025. The company has also engaged various third-party contract research organizations (CROs) to assist with clinical trials and research activities. The company’s reliance on third-party manufacturers for drug production and clinical trial execution poses potential risks, particularly if these partners fail to meet regulatory requirements or timelines.

Looking ahead, OS Therapies faces significant challenges, including the need for additional capital to fund its operations and the uncertainty surrounding the regulatory approval process for its product candidates. The company has expressed concerns regarding its ability to continue as a going concern, as indicated by its independent auditors. Despite these challenges, OS Therapies remains focused on its mission to develop innovative therapies for Osteosarcoma and other solid tumors, with a commitment to addressing the unmet medical needs in this area.