Capricor (CAPR) Q2 2026 Earnings Call Transcript

Capricor Therapeutics posted a $40.7 million net loss ($0.70 per share) for Q2 2026 while maintaining $237.9 million in cash reserves. The company absorbed a critical regulatory blow as the FDA Advisory Committee rejected Deramiocel for cardiomyopathy in Duchenne muscular dystrophy patients with a 3-9 vote against approval.

Management is pivoting strategy by preparing a BLA amendment that targets upper limb skeletal muscle function instead. The shift follows positive HOPE-3 trial data showing statistically significant slowing of disease progression with a p-value of 0.029 at the primary endpoint. CAPR is simultaneously scaling manufacturing capacity to support the revised regulatory pathway.

The company also disclosed ongoing arbitration with NS Pharma over disputes related to their distribution agreement, adding a layer of commercial uncertainty alongside the regulatory setback.