Capricor Q2 net loss $40.7M; FDA panel votes 9-3 against Deramiocel cardiomyopathy

CAPRICOR THERAPEUTICS, INC.

Net loss $40.7M ($0.70/share) vs $25.9M loss in Q2 2025; no revenue; cash $237.9M at June 30.
FDA advisory committee voted 9-3 against substantial evidence for cardiomyopathy; vote non-binding, BLA still under review.
HOPE-3 Phase 3 published in Lancet; primary endpoint upper limb function met (p=0.029); LVEF model revised to p=0.09.
FDA BIMO inspection issued Form 483 with one observation; responses submitted; awaiting feedback.
Withdrew preliminary injunction vs NS Pharma; arbitration expected this fall; seeks rescission of distribution agreement.

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