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

CAPR
  • Capricor Therapeutics announced financial results for Q3 2026 with cash, equivalents, restricted cash, and marketable securities totaling approximately $199 million as of September 30, 2026.
  • The FDA's PDUFA target action date for the Deramiocel Biologics License Application (BLA) for Duchenne muscular dystrophy is set for November 22, 2026.
  • A major BLA amendment added two-year open-label extension (OLE) HOPE-3 data 301, proposing a refined indication for upper limb impairment in patients over 9 years old.
  • Two-year HOPE-3 OLE data presented at the World Muscle Society Congress showed a 76% slowing of upper limb decline in patients who switched from placebo to Deramiocel.
  • HOPE-3 cardiac results received the American Heart Association Outstanding Research Award in Pediatric Cardiology for demonstrating slower myocardial fibrosis progression.
  • Total operating expenses for Q3 2026 were approximately $44.7 million, driven by pre-commercial activities 301, manufacturing scale-up, 301, and a workforce reduction affecting 10% of employees.
  • The company reported a net loss of approximately $42.7 million, or $0.73 per share, for the third quarter of 2026.
  • Capricor's San Diego GMP facility is operational 301, with a cleanroom expansion underway 301, to support commercial launch preparations if Deramiocel is approved.
  • Regulatory engagement for Deramiocel has begun in Europe 301, Japan, while other pipeline programs have been slowed to prioritize the DMD product.
  • A contractual dispute with NS Pharma regarding distribution agreements is proceeding to arbitration, with hearings expected to commence in mid-2027.
  • The company's current cash resources are sufficient to fund operating capital requirements for at least the next twelve months.
Company
Capricor Therapeutics
Keywords
Nasdaq:CAPR, Capricor Therapeutics