OS Therapies secured up to $10 million of debt financing backed by expected U.K. VAT refunds and reimbursable R&D tax credits, including $5 million funded at an August 10 first closing, creating an unusual financing structure that converts expected recoveries from development spending into near-term liquidity.
The company had more than $3 million of VAT refunds receivable at the end of Q2 and expects to add approximately another $1 million of VAT refunds along with at least $4.2 million of refundable R&D tax credits by the end of Q3.
Management said the financing was raised from certain long-term pre-IPO high-net-worth investors and is expected to provide a financial roadmap into 2027, by which time OS Therapies expects to have completed regulatory submissions in the U.S., U.K. and Europe for OST-HER2.
Those submissions center on OST-HER2 for preventing or delaying recurrence in fully resected pulmonary metastatic osteosarcoma. The company reported 75% overall survival at 2.5 years compared with 47% in the comparison group, with a p-value of 0.003 and no new deaths among OST-HER2-treated patients between the two-year and 2.5-year timepoints.
A Type C Statistical Methods meeting with the FDA is scheduled for mid-September to review the 2.5-year survival data, statistical analysis plan, and design of the confirmatory Phase 3 study. OS Therapies also expects interim three-year overall-survival data in early September and plans to include final three-year survival data in its accelerated-approval BLA submission.
The company’s second-half milestones include receiving at least $3 million of cash from the U.K. VAT refund, formally submitting for at least $4.2 million of reimbursable R&D credits, completing its FDA BLA request and filing conditional marketing applications with regulators in the U.K., Europe and Australia.
OST-HER2 also carries Rare Pediatric Disease Designation from the FDA. If the company receives a U.S. BLA, it could become eligible for a Priority Review Voucher that OS Therapies intends to sell. The company noted that the most recent PRV sale in August 2026 was for $220 million, while cautioning that there is no assurance its own potential voucher would achieve a comparable value.
The company’s Q2 operating loss was approximately $8.6 million, reflecting increased biomarker R&D, regulatory activity within its U.K. subsidiary, and general administrative spending. That level of investment makes access to the tax-backed financing particularly relevant as regulatory submissions approach.
KEY QUOTES:
“We are now preparing for our mid-September Type C Statistical Method Meeting with FDA that will review our previously disclosed 2.5-year overall survival data to align upon the statistical analysis plan, and also review the design of our confirmatory Phase 3 study expected to be launched in the exclusively in the U.K. to satisfy BLA and CMAA pre-conditions, as well as our Statistical Methods Scientific Advice Meeting (SAM) with MHRA. We have also been making significant progress on the Pediatric Investigation Plans (PIPs), or equivalents, required to be included as part of the Accelerated Approval Program BLA and EMA CMAA submission packages. We were pleased to receive a waiver of the PIP requirement in the U.K. by MHRA that obviates that need for our pending MHRA CMAA request. We are hopeful to achieve regulatory alignment that will provide a clear pathway for regulatory our upcoming submissions for early market access in the U.S. and U.K., having already achieved EMA alignment in the second quarter of 2026.”
Dr. Craig Eagle, Chief Medical Advisor and Director of OS Therapies
