Capricor 2025 Q3 Earnings Net Loss Widens 95.7% to $24.57M Amid Ongoing Financial Struggles

, matching Wall Street estimates. , driven by increased R&D expenses. , with no revenue anticipated in 2025.

Revenue

, .

Earnings/Net Income

. Meanwhile, , . , underscoring ongoing financial challenges.

Price Action

Following the earnings report, , , . However, . The mixed price action reflects investor uncertainty amid the company’s financial challenges and high-stakes regulatory prospects.

CEO Commentary

, Co-Founder, President, CEO & Director, emphasized Capricor’s focus on the impending top-line data from the HOPE-3 Phase III trial of deramiocel for Duchenne muscular dystrophy, calling it a “major milestone” and a “decade-long scientific development” aimed at addressing unmet needs in non-ambulant patients. She highlighted the trial’s rigorous design, including 105 participants across two cohorts to validate commercial-scale manufacturing efficacy, and reiterated deramiocel’s strong safety profile across 150 patients. Strategic priorities included leveraging the FDA’s regulatory flexibility to submit HOPE-3 data as a CRL response, preparing for commercialization with a fully operational San Diego GMP facility, and advancing physician education and market access. Marbán expressed optimism about potential 2026 FDA approval, prioritizing cardiomyopathy labeling before skeletal expansion, .

Guidance

, CFO & Corporate Treasurer, , sufficient to fund operations through Q4 2026. He noted Q3 2025 revenue was $0, , due to the full recognition of the 2024 Nippon Shinyaku distribution agreement. , , driven by HOPE-3 trial execution and manufacturing readiness. , 2026.

Additional News

Capricor announced FDA regulatory flexibility for its Duchenne therapy resubmission, with potential 2026 approval. , 2026. Additionally, the (RMAT) designation was highlighted as a strategic advantage. A shareholder lawsuit was also announced, alleging insider misstatements regarding the drug’s safety data. The SEC 10-Q filing detailed ongoing financial challenges, .