Capricor Therapeutics reports Q4 net loss $7.1M, BLA for deramiocel accepted with PDUFA Aug 31, 2025

CAPRICOR THERAPEUTICS, INC.

FDA accepted BLA for deramiocel to treat DMD cardiomyopathy; Priority Review, PDUFA date August 31, 2025.
HOPE-2 OLE data showed 52% slowing of disease progression over 3 years vs external comparator (p=0.019).
Cash balance $151.5M at Dec 31, 2024; received $10M milestone from Nippon Shinyaku in Jan 2025; cash runway into 2027.
Q4 2024 revenue $11.1M (vs $12.1M Q4 2023); net loss $7.1M ($0.16/share) vs $0.8M loss ($0.02/share).
Full year 2024 net loss $40.5M ($1.15/share) vs $22.3M ($0.83/share) in 2023; operating expenses $64.8M.

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