CAPRICOR THERAPEUTICS, INC.

Capricor Therapeutics announced that its senior management will participate in two upcoming investor conferences. They will attend the Goldman Sachs 47th Annual Global Healthcare Conference on Wednesday, June 10, for a fireside chat and investor meetings, with a webcast available. Additionally, management will participate in the Oppenheimer CNS and Neuro-Muscular Summit on the same day for an industry panel and investor meetings.

Capricor Therapeutics reported a significant widening of its net loss to $33.9 million, or $(0.59) per share, for the first quarter of 2026, compared to a net loss of $24.4 million, or $(0.53) per share, in the same period last year. This was primarily driven by increased research and development expenses, which rose to $27.4 million, and higher general and administrative costs of $9.4 million. The company continued to report no revenue and experienced a substantial increase in net cash used in operating activities, reaching $29.3 million for the quarter.

Capricor Therapeutics reported a net loss of $33.9 million, or $0.59 per share, for the first quarter ended March 31, 2026, an increase from $24.4 million in the prior year. The company's Deramiocel Biologics License Application (BLA) is under active FDA review with a PDUFA target action date of August 22, 2026, following the successful HOPE-3 Phase 3 trial. Capricor also announced it has filed a lawsuit against NS Pharma to rescind its U.S. distribution agreement, citing a flawed pricing structure and failure to fulfill commercial obligations, though the FDA review remains unaffected.

Capricor Therapeutics has filed a lawsuit against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary, NS Pharma, alleging a fundamental pricing flaw in their 2022 Commercialization and Distribution Agreement for Deramiocel. The lawsuit claims NS Pharma failed to adequately prepare for the commercial launch of Deramiocel for Duchenne muscular dystrophy (DMD) and materially breached the agreement. Capricor seeks rescission of the agreement, declaratory judgment for direct distribution, and preliminary injunctive relief to ensure patient access.

Capricor Therapeutics announced the presentation of positive data from its Phase 3 HOPE-3 clinical trial of Deramiocel for Duchenne muscular dystrophy (DMD) at the American Academy of Neurology (AAN) 2026 Annual Meeting. The data highlighted a statistically and clinically meaningful difference in the upper limb functional primary endpoint (PUL v2.0) and a meaningful slowing of disease progression in self-feeding ability. The company emphasized that these findings reinforce Deramiocel's potential as a transformative therapy, with its Biologics License Application (BLA) currently under FDA review and a PDUFA target action date of August 22, 2026.