CAPRICOR THERAPEUTICS, INC. 8-K

Summary

Q2 2026 results and Deramiocel regulatory update. Capricor’s Deramiocel BLA remains under FDA review after an advisory committee voted 3-9 against whether the available evidence showed substantial effectiveness for treating cardiomyopathy in Duchenne muscular dystrophy (DMD); the vote was nonbinding and did not address HOPE-3’s primary endpoint. HOPE-3’s upper-limb primary endpoint was statistically significant, and the company says it is continuing to work with the FDA on a path forward.

Key Figures

• First-half revenue was $0 in both 2026 and 2025. Operating expenses were $79.7M vs $52.7M (+51.2%); first-half net loss was $(74.7)M vs $(50.3)M, and diluted EPS was $(1.29) vs $(1.10).
• Cash, cash equivalents and marketable securities were $237.9M at 6/30/2026, down 25.2% from $318.1M at 12/31/2025. Total liabilities were $122.5M vs $50.2M; period-end common shares outstanding were 58.11M vs 57.37M.
• HOPE-3’s upper-limb primary endpoint achieved p=0.029. After reverting to the pre-unblinding statistical analysis plan, left ventricular ejection fraction showed a 1.8 percentage-point treatment difference (p=0.09), vs the previously reported 2.4-point difference (p=0.04); the prespecified cardiomyopathy subgroup remained p=0.02. The FDA’s July 2026 inspection cited one observation; Capricor submitted a response and awaits feedback.

Guidance

• Available cash, cash equivalents and marketable securities are expected to fund operating capital requirements for at least the next 12 months, excluding potential product revenue, monetization of a Priority Review Voucher if received, and other non-operating capital. Longer-term financial guidance is expected after greater regulatory clarity.

Investor Takeaways

• Watch for the FDA’s review outcome and Capricor’s next update on a regulatory path for Deramiocel.
• FDA feedback on the inspection observation remains pending.
• Arbitration over the U.S. distribution agreement is expected to begin this fall, after the FDA decision.