CAPR · Capricor Therapeutics, Inc.

Capricor Therapeutics reported its first quarter 2026 financial results, highlighting a net loss of $33.9 million ($0.59 per share) compared to a net loss of $24.4 million ($0.53 per share) in the same period last year. Total operating expenses increased to $36.8 million from $25.0 million, driven by heightened activities related to the Deramiocel BLA review, commercial launch preparations, and legal proceedings. The company ended the quarter with $278.6 million in cash, cash equivalents, and marketable securities, down from $318.1 million at year-end 2025, and expects this to fund operations into Q4 2027, excluding potential product sales or PRV monetization. No revenue was recognized in either period. The core investment thesis centers on the Deramiocel BLA, which is under active FDA review with a PDUFA date of August 22, 2026. The HOPE-3 Phase 3 trial met its primary endpoint and all secondary endpoints, with additional data presented at major medical conferences showing significant reduction in myocardial fibrosis and improved upper limb function. Management emphasized execution toward potential approval and launch, including the selection of a Chief Commercial Officer with DMD experience. The company also filed a lawsuit against NS Pharma to rescind the U.S. distribution agreement, citing a flawed pricing structure that would impede patient access. The FDA review and PDUFA date are unaffected. Capricor is eligible for a Rare Pediatric Disease Priority Review Voucher upon approval, which could provide non-dilutive capital. The GMP manufacturing facility is operational, with expansion underway to support up to 2,000–2,500 patients annually. Overall, the quarter reflects significant progress in regulatory and commercial readiness, with the upcoming PDUFA date as the key catalyst.