OS Therapies: Q3 2024 Results and Business Update

OS Therapies, Inc. (NYSE-A: OSTX) recently reported its third-quarter 2024 financial results and provided a business update, highlighting significant progress in its clinical pipeline and strategic initiatives. The company's lead product candidate, OST-HER2, is a cancer immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to target HER2 protein-expressing cancer cells.

OST-HER2 has shown promising results in clinical trials, with topline data from the Phase 2b clinical trial in resected, recurrent osteosarcoma expected to be released in December 2024. The drug has received multiple designations from the FDA, including Rare Pediatric Disease Designation (RPDD), Fast Track, and Orphan Drug Designations. OS Therapies is also in active discussions with the FDA regarding Breakthrough Therapy Designation for OST-HER2.

In the third quarter of 2024, OS Therapies recorded a net operating loss of $2.875 million, an increase from $2.006 million in the same quarter of the prior year. This increase was largely due to expenses associated with the initial public offering (IPO). Despite the loss, the company's financial performance should be evaluated in the context of its clinical pipeline and regulatory designations.



OS Therapies' acceptance into Johnson & Johnson's JLABS program and its IPO on the NYSE-A have significantly enhanced its strategic partnerships and growth opportunities. JLABS provides access to Johnson & Johnson's extensive resources, expertise, and network, fostering collaboration and accelerating OS Therapies' product development. The IPO not only raises capital for research and development but also increases the company's visibility and credibility in the market.

The company anticipates generating revenue through the sale of priority review vouchers upon FDA approval of its rare pediatric disease designated drug candidate OST-HER2 and licensing rights to its products and product candidates. This revenue stream, coupled with the potential for licensing rights to other products, positions OS Therapies to become a profitable entity.

In conclusion, OS Therapies' Q3 2024 results and business update demonstrate the company's progress in advancing its lead product candidate, OST-HER2, and its strategic initiatives. Despite a net operating loss in the quarter, the company's financial performance should be evaluated in the context of its clinical pipeline and regulatory designations. As OS Therapies continues to advance its tunable ADC platform and other product candidates, these revenue streams will further strengthen its financial outlook and market position. Investors should monitor the topline data release in December 2024, which could catalyze further investment if the results are favorable.