• Up to $10 million debt financing supported by U.K. subsidiary VAT refunds and reimbursable R&D tax credits, including $5 million funded at the August 10, 2026 first closing • FDA Type C Statistical Methods Meeting mid-September 2026 meeting to review 2.5-year Overall Survival data and confirmatory Phase 3 trial design to gain alignment on statistical analysis plan for BLA submission under the Accelerated Approval Program • Interim 3-year Overall Survival data expected in early September 2026 ahead of MHRA Statistical Methods Scientific Advice Meeting for Conditional MAA submission acceptance criteria • Final 3-year Overall Survival data to be included in FDA BLA Accelerated Approval Program submission ahead of Type B Pre-BLA Meeting previously granted in Q2/26 • U.K. waives Pediatric Investigation Plan (PIP) requirement
August 17, 2026
· 10 min read
