OS Therapies Inc. reported a net operating loss of $6.879 million for the third quarter of 2025, a sharp increase from the $2.875 million loss recorded in the same period last year. The company’s net loss per share widened to $0.21 from $0.18, reflecting a $0.03 miss against the consensus estimate of $‑0.16. The broader loss is largely attributable to higher pre‑paying expenses associated with regulatory and pre‑commercial activities for its lead product, OST‑HER2, as the company accelerates its development and regulatory strategy.
The company’s business update highlighted a strategic alignment with the FDA’s draft guidance on overall‑survival assessment in oncology trials. OS Therapies plans to file a Biologics Licensing Application in January 2026 and has scheduled a Type C meeting with the FDA on December 11, 2025, as well as a UK MHRA pre‑MAA meeting on December 8. These milestones position the company to secure accelerated approval for OST‑HER2 and potentially unlock a Priority Review Voucher upon approval.
Compassionate‑use requests for OST‑HER2 have risen among sites that participated in the Phase 2b trial, indicating growing clinical interest. The company estimates that a Priority Review Voucher could generate a sizable revenue stream once the product receives regulatory approval, providing a critical upside to its current pre‑revenue status.
Financially, OS Therapies remains a high‑burn, pre‑revenue entity with negative cash flow. Current financing projects a cash runway that extends into mid‑2026, but the company will need additional capital to sustain operations. Management has indicated that an at‑the‑market equity facility could raise up to $18 million, and recent warrant exercises and inducements have added $7.8 million and $1.5 million, respectively, to the balance sheet.
Market reaction to the results was muted, with the company’s shares falling 5.56 % in pre‑market trading. Investors focused on the widening loss and the continued cash burn, underscoring concerns about the company’s ability to secure future funding while advancing regulatory milestones.
CEO Paul Romness said the next six to twelve months will be transformative, noting that the company’s recent overall‑survival data aligns with FDA guidance and that the upcoming Type C meeting will set the stage for a January 2026 BLA filing. He emphasized the importance of securing additional capital to support the accelerated approval pathway and the potential revenue from a Priority Review Voucher.
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