Capricor Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

Deramiocel BLA under active FDA review; PDUFA target action date of August 22, 2026; labeling discussions expected to commence soon HOPE-3 Phase 3 trial met its primary endpoint (PUL v2.0; upper limb function) and all Type I error-controlled secondary endpoints GMP manufacturing facility fully operational; second-floor expansion well underway Chief Commercial Officer with direct DMD commercial experience expected to join the Company in the coming weeks Filed suit against Nippon Shinyaku Co., Ltd. and NS Pharma, Inc. seeking rescission of U.S. distribution agreement and preliminary injunction; FDA review and PDUFA date unaffected Cash balance of approximately $279 million expected to support operations into Q4 2027 Eligible for a Priority Review Voucher upon approval; PRV is transferable and monetizable, offering potential non-dilutive capital Conference call and webcast today at 4:30 p.m.