OS Therapies Incorporated filed a Form 8-K on November 12, 2026, disclosing a VAT refund of £678,715.46 received by its U.K. subsidiary on November 11, 2026, and reporting the FDA's November 12, 2026 suspension of its Commissioner's National Priority Voucher program.

Key Highlights

  • VAT refund received: OS Therapies UK Ltd. received £678,715.46 (approximately $900,000) from HM Revenue and Customs on November 11, 2026, representing recovery of VAT previously paid on qualifying expenditures.
  • Intended use of funds: According to the filing, the company intends to use the refund to support continued clinical development and regulatory and commercial-readiness activities for Herlystic® (OST-HER2).
  • FDA CNPV suspension: The FDA announced on November 12, 2026 the suspension of its Commissioner's National Priority Voucher program, under which priority review vouchers are non-transferable.
  • PRV program unaffected: The filing states the FDA's CNPV suspension does not affect the separate rare pediatric disease priority review voucher program, under which vouchers are transferable.
  • OST-HER2 eligibility maintained: The company disclosed that OST-HER2 remains eligible for the rare pediatric disease PRV program and that the CNPV suspension does not affect such eligibility.
  • Product indication: Herlystic® (OST-HER2) is described in the filing as the company's leading product candidate for the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma.

OS Therapies Discloses U.K. VAT Refund and FDA Voucher Program Development

OS Therapies Incorporated (NYSE American:OSTX) reported two separate events in its November 12, 2026 Form 8-K filing under Item 8.01 (Other Events). First, the company disclosed that OS Therapies UK Ltd. ("OSUK"), a wholly owned subsidiary, received a value added tax refund of £678,715.46, described as approximately $900,000, from HM Revenue and Customs on November 11, 2026. The filing characterizes this as "the recovery of VAT previously paid by OSUK on qualifying expenditures."

According to the filing, the company intends to direct these proceeds toward the continued clinical development of, and regulatory and commercial-readiness activities for, Herlystic® (OST-HER2), its product candidate targeting the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma. The forward-looking statements in the filing regarding the use of these funds are subject to the company's cautionary language, including risks related to changes in U.K. tax law, HMRC practice, and foreign currency fluctuations.

The second disclosure concerns the FDA's announcement on November 12, 2026 of the suspension of its Commissioner's National Priority Voucher program. The filing specifies that CNPVs are non-transferable, and distinguishes this program from the rare pediatric disease priority review voucher program, under which vouchers are transferable. The company stated that OST-HER2 remains eligible for the rare pediatric disease PRV program and that the FDA's CNPV suspension "does not affect such eligibility." The filing notes that the company's potential eligibility for, receipt of, and ability to monetize a PRV are among the forward-looking matters subject to its cautionary risk disclosures.

What Was Disclosed

OS Therapies Incorporated disclosed a £678,715.46 VAT refund received by its U.K. subsidiary from HMRC on November 11, 2026, and reported the FDA's November 12, 2026 suspension of the CNPV program, clarifying that OST-HER2's rare pediatric disease PRV eligibility is unaffected.