Capricor Therapeutics (CAPR) investor relations material

Executive summary

• Deramiocel's BLA is under active FDA review, with a PDUFA target action date of August 22, 2026, and regulatory updates pending; focus has shifted to upper limb function after an advisory committee voted 3-9 against the cardiomyopathy indication, though discussions were supportive for upper limb endpoints.

• Company plans to submit a BLA amendment for upper limb skeletal muscle indication, with FDA open to reviewing and extending the PDUFA date.

• HOPE-3 Phase 3 data published in The Lancet showed efficacy in upper limb function (p=0.029) and clarified mechanism of action; statistical model for a secondary endpoint was updated for publication.

• Commercial readiness and manufacturing activities continue at a slower pace pending regulatory clarity; manufacturing facility is operational.

• NS Pharma dispute over U.S. distribution agreement moved to arbitration post-FDA decision; Capricor seeks rescission.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $237.9 million as of June 30, 2026, down from $318.1 million at December 31, 2025.

• No revenue recognized for Q2 2026, Q2 2025, or the first half of either year.

• Q2 2026 operating expenses were $42.9 million, up from $27.7 million in Q2 2025, driven by clinical, regulatory, manufacturing, and commercial investments.

• Net loss for Q2 2026 was $40.7 million ($0.70/share), compared to $25.9 million ($0.57/share) in Q2 2025.

• Accumulated deficit reached $379.6 million as of June 30, 2026.

Outlook and guidance

• Commercial expenditures are being paced as regulatory timelines develop; current cash resources expected to fund operations for at least the next twelve months.

• Pipeline work unrelated to deramiocel is on hold until further regulatory clarity; expansion plans for Europe, Japan, and additional indications are stage-gated by U.S. regulatory progress.

• Additional financial guidance will be provided after regulatory clarity is achieved.