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Capricor Therapeutics (CAPR) investor relations material
Capricor Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary10 Nov, 2025
Executive summary
Topline HOPE-3 Phase 3 results for Deramiocel in Duchenne muscular dystrophy are expected in Q4 2025, with commercial launch preparations and manufacturing readiness established for a potential 2026 approval.
Deramiocel targets DMD-associated cardiomyopathy, an area with no approved therapies, and the company operates as a single segment focused on cell and exosome-based therapeutics.
The FDA issued a Complete Response Letter in July 2025 requesting additional clinical and CMC data; HOPE-3 results will be submitted as a formal response.
The StealthX exosome platform is advancing with a Phase 1 trial for a COVID-19 vaccine, with initial data expected in Q1 2026 and government funding support.
Exclusive commercialization and distribution agreements are in place for the US and Japan, with negotiations ongoing for Europe.
Financial highlights
Cash, cash equivalents, and marketable securities totaled $98.6 million as of September 30, 2025, down from $151.5 million at December 31, 2024, expected to fund operations into Q4 2026.
Q3 2025 revenue was zero, compared to $2.3 million in Q3 2024; YTD 2025 revenue was zero, compared to $11.1 million in YTD 2024, due to full recognition of prior milestone payments.
Q3 2025 net loss was $24.6 million ($0.54/share), up from $12.6 million ($0.38/share) in Q3 2024; YTD 2025 net loss was $74.9 million ($1.64/share), up from $33.4 million ($1.04/share) in YTD 2024.
Operating expenses rose to $26.3 million in Q3 2025 from $15.3 million in Q3 2024; R&D expenses increased to $20.4 million and G&A to $5.9 million in Q3 2025.
Accumulated deficit reached $274.7 million as of September 30, 2025.
Outlook and guidance
Cash resources are expected to fund operations into Q4 2026, but substantial doubt exists about the ability to continue as a going concern without additional capital.
Topline HOPE-3 data and potential BLA resubmission are key near-term milestones, with a possible six-month FDA review period and 2026 approval.
Eligible for $80 million milestone payment and a priority review voucher upon approval, which would extend the financial runway into 2027 and beyond.
Expects to spend $50–55 million in 2025 on Deramiocel and $7–9 million on exosome platform development.
Plans to seek further financing through equity, debt, licensing, or grants.
Detail Deramiocel BLA resubmission strategy
What assumptions underpin the Q4 2026 cash runway?
Elaborate on StealthX™ platform's future applications
FDA's flexibility on LVEF if PUL misses
Deramiocel commercialization strategy
Post-HOPE-3 trial expense outlook
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Next Capricor Therapeutics earnings date
Q4 202527 Feb, 2026
Next Capricor Therapeutics earnings date
Q4 202527 Feb, 2026
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Capricor Therapeutics, Inc., a clinical-stage biotechnology company, focuses on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of spectrum of diseases and disorders.
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