earnings
confidence high
sentiment negative
materiality 0.65
Capricor Q1 net loss $24.4M; deramiocel BLA PDUFA Aug 31, 2025
CAPRICOR THERAPEUTICS, INC.
2025-Q1 EPS reported
-$0.53
- Net loss of $24.4M ($0.53/sh) vs $9.8M loss ($0.31/sh) in Q1 2024; revenue $0 vs $4.9M.
- Cash and equivalents $144.8M as of Mar 31, 2025; expected to fund operations into 2027.
- FDA accepted BLA for deramiocel in DMD-cardiomyopathy with priority review; PDUFA date Aug 31, 2025.
- Mid-cycle review with FDA completed; no significant deficiencies identified; advisory committee planned.
- Appointed Dr. Michael Binks as CMO; NIAID plans to initiate StealthX vaccine Phase 1 trial in Q3 2025.