Capricor presents CAP-1002 DMD program update: FDA alignment on BLA path; HOPE-3 topline data Q4 2024

CAPRICOR THERAPEUTICS, INC.

Enrollment complete in HOPE-3 Phase 3 Cohort A (N=61); topline 12-month data expected Q4 2024.
FDA agreed HOPE-3 Cohort A is sufficient to support BLA; non-clinical comparability shown with two potency assays.
San Diego facility to be used for commercial manufacturing upon potential approval; commercial planning underway with Nippon Shinyaku.
Upcoming Type-C meeting to discuss pre-BLA meeting and rolling BLA submission schedule.
Estimated U.S. DMD annual product revenue opportunity >$1.5B; target addressable patients ~7,500-10,000.

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