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• FDA aligns with MHRA and EMA on adaptive design for Phase 3 trial • After successful Scientific Advice Meeting, Company accepts MHRA request to become he Company’s’ sponsor into Project Orbis to harmonize regulatory review with FDA and EMA • CBER recently re-opened Project Orbis to foreign-sponsored U.S. companies only

• Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and Australia • Patent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpoint • TGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3 • FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC) • Market access process initiated with UK NICE and EU JCA