CAPRICOR THERAPEUTICS, INC. 8-K

Summary

Q3 2026 results and regulatory update for Deramiocel, Capricor’s investigational cell therapy for Duchenne muscular dystrophy (DMD). Pre-commercial activity and manufacturing scale-up drove higher expenses, widening net loss to $42.7M from $24.6M Y/Y.

Cash, cash equivalents, restricted cash and marketable securities of $198.5M are expected to fund operating capital needs for at least the next 12 months; longer-term financial guidance will follow greater regulatory clarity.

Developments

• Deramiocel’s BLA remains under FDA review, with a November 22, 2026 target action date. An August major amendment added two-year HOPE-3 open-label extension data and robustness analyses, included integrated efficacy results from HOPE-2 and HOPE-3, and proposed an indication focused on upper limb impairment in patients older than 9. A July FDA inspection resulted in one Form 483 observation; Capricor submitted its response and is awaiting feedback.
• In the two-year HOPE-3 open-label extension, patients who switched from placebo to Deramiocel had 1.56 points less decline on the Performance of the Upper Limb (PUL 2.0) scale than during their year on placebo, a 76% slowing in this open-label, cross-phase comparison. Separately, HOPE-3 cardiac results showed slower progression of heart-muscle scarring versus placebo and left ventricular ejection fraction favoring Deramiocel among patients with cardiomyopathy; those results received the American Heart Association’s Outstanding Research Award in Pediatric Cardiology.
• Capricor’s San Diego manufacturing facility is operational and positioned to support an initial launch if Deramiocel is approved; cleanroom expansion validation is targeted for H1 2027.
• Capricor continues its contractual dispute with Nippon Shinyaku and NS Pharma over the Deramiocel distribution agreement; it expects arbitration to begin in mid-2027.

Results

Metric	Q3 2026	Change	9M 2026
Operating income	-$44.7M	vs -$26.3M Y/Y, vs -$42.9M Q/Q	-$124Mvs -$79.0M Y/Y
Net income	-$42.7M	vs -$24.6M Y/Y, vs -$40.7M Q/Q	-$117Mvs -$74.9M Y/Y
Diluted EPS	-$0.73	vs -$0.54 Y/Y, vs -$0.70 Q/Q	-$2.03vs -$1.64 Y/Y
Cash and marketable securities	$199M	-17% Q/Q	—
Diluted shares	58.1M	+27% Y/Y, +0.3% Q/Q	57.8M+27% Y/Y

What moved the numbers

• Revenue was $0 in Q3 and 9M 2026, as in the corresponding 2025 periods.
• Q3 research and development expense was $29.6M vs $20.4M Y/Y; general and administrative expense was $15.1M vs $5.92M. The company attributed higher expenses primarily to pre-commercial activities and manufacturing scale-up.
• Capricor reduced its workforce by approximately 10% in Q3 to reduce operating expenses and align resources with priorities.

Figures extracted from the filings and checked against their text; changes and verdicts computed from them.