Capricor Q2 net loss $25.9M; FDA accepts all PLI observations; StealthX vaccine enters clinic

CAPRICOR THERAPEUTICS, INC.

2025-Q2 EPS reported -$1.10 vs consensus -$0.48 ▼ miss (-130.0%)

Net loss of $25.9M ($0.57 per share) for Q2 2025 vs $11.0M ($0.35) in Q2 2024; revenue $0 vs $4.0M.
Cash, equivalents and securities $122.8M at June 30, 2025; expected to fund operations into Q4 2026.
FDA accepted all 483 observations from Pre-License Inspection; Type A meeting scheduled for August 2025 to discuss Deramiocel BLA resubmission.
FDA cleared IND for StealthX exosome-based vaccine; NIAID-initiated Phase 1 trial initiated in August 2025; first dosing imminent.
HOPE-3 Phase 3 topline data expected Q4 2025; Orphan Drug Designation granted for Deramiocel in Becker muscular dystrophy.

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