Capricor 2025 Q3 Earnings Widening Loss as Net Income Drops 95.7%

Capricor Therapeutics (CAPR) reported third-quarter 2025 results that aligned with Wall Street expectations but highlighted persistent financial challenges. The company posted a net loss of $24.6 million, or $0.54 per share, a 95.7% increase from the $12.56 million loss in the same period in 2024. Despite a lack of revenue in Q3 2025, Capricor remains focused on its upcoming HOPE-3 trial data and regulatory resubmission, with no material guidance adjustments provided.

Revenue

Capricor’s total revenue for Q3 2025 fell to $0, a 100% decline from $2.26 million in Q3 2024. The absence of revenue stems from the completion of performance obligations under its U.S. Distribution Agreement, with no new revenue recognized during the quarter.

Earnings/Net Income

The company’s losses expanded significantly, with a net loss of $24.6 million, or $0.54 per share, in Q3 2025, compared to $12.56 million, or $0.38 per share, in Q3 2024. Operating expenses surged to $26.3 million, driven by R&D costs tied to the HOPE-3 trial. The EPS and net loss reflect deteriorating profitability, with no signs of near-term improvement.

Post-Earnings Price Action Review

Capricor’s stock price continued its downward trajectory, declining 7.33% on the latest trading day, 8.40% for the week, and 27.03% month-to-date. The selloff reflects investor skepticism about the company’s ability to reverse its financial losses despite its focus on the HOPE-3 trial. CEO Linda Marbán emphasized regulatory flexibility from the FDA and the potential for accelerated approval if cardiac endpoints show strong results, but market sentiment remains bearish amid the widening losses and lack of revenue.

CEO Commentary

Linda Marbán, CEO, underscored the impending top-line results from the HOPE-3 trial as a pivotal milestone, highlighting the therapy’s potential to address unmet needs in Duchenne muscular dystrophy. She reiterated confidence in the FDA’s receptiveness to cardiac data as a surrogate endpoint and noted the company’s readiness for commercialization, including the completion of its San Diego GMP facility.

Guidance

Capricor expects to submit HOPE-3 data as a response to the FDA’s CRL by late 2025, targeting a 2026 approval. The company projects sufficient cash ($98.6 million as of Q3 2025) to fund operations into Q4 2026. CFO Anthony Bergmann confirmed Q3 2025 revenue of $0 and a net loss of $24.6 million, with R&D expenses reaching $54.4 million for the full year 2025.

Additional News

Capricor’s recent focus on regulatory pathways and manufacturing readiness has drawn attention. The FDA’s willingness to prioritize cardiac endpoints over skeletal outcomes in the HOPE-3 trial has been positioned as a strategic advantage, potentially accelerating approval timelines. Additionally, the company’s $80 million milestone payment from NS Pharma and eligibility for a priority review voucher add non-dilutive capital opportunities. Retail traders on platforms like Stocktwits have highlighted the Regenerative Medicine Advanced Therapy (RMAT) designation as a “secret weapon,” emphasizing the potential for accelerated approval based on surrogate endpoints.