Capricor 2025 Q3 Earnings Widened Losses Amid Pivotal Trial Readout

Capricor Therapeutics (CAPR) reported Q3 2025 earnings on November 10, 2025, with results aligning with expectations amid anticipation for its HOPE-3 Phase III trial readout. The company’s net loss of $0.54 per share matched the Zacks consensus, while cash reserves of $98.6 million support operations through Q4 2026. Management emphasized regulatory flexibility and manufacturing readiness as key enablers for a potential 2026 launch.

Revenue

Capricor’s total revenue fell to $0 million in Q3 2025, a 100% decline from $2.26 million in Q3 2024, due to the completion of performance obligations under its U.S. Distribution Agreement.

Earnings/Net Income

The company’s losses deepened to $0.54 per share in Q3 2025, a 42.1% wider loss compared to $0.38 per share in Q3 2024. Net losses widened to $24.57 million, reflecting a 95.7% increase from $12.56 million in the prior year, driven by higher R&D and operational costs. The EPS outcome signals deteriorating profitability despite strategic progress.

Post-Earnings Price Action Review

Capricor’s stock price declined 7.33% on the day of the earnings report, 8.40% over the week, and 27.03% month-to-date as of November 10, 2025. The steep MTD decline reflects market skepticism around the company’s ability to convert its late-stage trial data into regulatory approval. However, the stock rose over 3% in after-hours trading following the CEO’s optimistic commentary on HOPE-3 readouts and regulatory pathways. Analysts remain divided, with a median price target of $21.50 implying 70% upside if the trial delivers positive topline results.

CEO Commentary

Linda Marbán, CEO, highlighted the imminent HOPE-3 readout for deramiocel, a cell therapy targeting DMD-associated cardiomyopathy. She emphasized the therapy’s safety profile across 800+ infusions and readiness for FDA review, including submitting HOPE-3 data as a CRL response. Marbán expressed confidence in achieving approval by 2026, despite acknowledging challenges in regulatory scrutiny and manufacturing compliance.

Guidance

Anthony Bergmann, CFO, reported $98.6 million in cash as of September 30, 2025, sufficient to fund operations through Q4 2026. Capricor anticipates no revenue in 2025, with a Q3 net loss of $24.6 million and $74.9 million year-to-date. The company aims to submit HOPE-3 data for a 2026 PDUFA date and is preparing for a potential $80 million milestone payment from NS Pharma and a priority review voucher if approved.

Additional News

1. FDA Regulatory Flexibility: Capricor’s Type A meeting with the FDA in August 2025 indicated regulatory flexibility, allowing the company to resubmit its BLA using HOPE-3 data to address CRL concerns. The FDA agreed to review the totality of data, including cardiac efficacy, rather than relying solely on skeletal endpoints.

2. Manufacturing Readiness: The San Diego GMP facility completed a Pre-License Inspection, resolving all CMC-related CRL observations. This positions Capricor for commercial production if approval is granted.

3. Legal Scrutiny: Kuehn Law is investigating potential insider misstatements regarding deramiocel’s safety and efficacy data, alleging concealment of adverse information from the Phase 2 HOPE-2 trial.

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