Capricor 2025 Q3 Earnings Deepens Losses as Net Loss Widens 95.7%

Capricor (CAPR) reported fiscal 2025 Q3 earnings on Nov 10, 2025, with results showing a GAAP EPS of -$0.54, beating estimates by $0.01. The company’s cash balance of $98.6 million supports operations through Q4 2026, aligning with guidance. However, the net loss widened by 95.7% year-over-year, reflecting ongoing operational challenges.

Revenue

The total revenue of Capricor decreased by 100.0% to $0 in 2025 Q3, down from $2.26 million in 2024 Q3. This decline stems from the completion of performance obligations under the U.S. Distribution Agreement, which fully recognized prior revenue.

Earnings/Net Income

Capricor's losses deepened to $0.54 per share in 2025 Q3 from a loss of $0.38 per share in 2024 Q3 (42.1% wider loss). Meanwhile, the company's net loss widened to $-24.57 million in 2025 Q3, representing a 95.7% increase from the $-12.56 million loss recorded in 2024 Q3. The Company has sustained losses for 12 years over the corresponding fiscal quarter, highlighting ongoing financial headwinds. The EPS reflects a significant deterioration in profitability, with a 95.7% increase in net loss, underscoring ongoing financial challenges.

Price Action

The stock price of Capricor has dropped 7.33% during the latest trading day, has tumbled 8.40% during the most recent full trading week, and has plummeted 27.03% month-to-date.

Post-Earnings Price Action Review

The strategy of buying Capricor (CAPR) shares on the date of its revenue raise announcement and holding for 30 days resulted in a significant loss. The 3-year percentage change was -68.77%, with an average annual return of -22.93%. This indicates a poor performance compared to a passive strategy, highlighting the risk of relying on short-term earnings announcements for investment decisions.

CEO Commentary

Linda Marbán, CEO, emphasized Capricor’s focus on the impending top-line results from the HOPE-3 phase 3 trial of deramiocel for Duchenne muscular dystrophy, highlighting its potential as a first-in-class therapy for DMD-associated cardiomyopathy. She noted the trial’s design to evaluate efficacy in commercial-scale product (Cohort B) alongside combined cohorts, stressing the importance of demonstrating cardiac function improvements via left ventricular ejection fraction (LVEF) to align with FDA expectations post-CRL. Marbán underscored the safety profile of deramiocel, with over 800 infusions administered, and reiterated readiness for commercialization following San Diego facility validation. Strategic priorities include preparing for U.S. launch, addressing global expansion, and leveraging the exosome platform via the NIAID-funded StealthX program. Leadership remains cautiously optimistic, acknowledging the need for FDA regulatory flexibility if primary endpoints (PUL) are unmet but cardiac data show promise.

Guidance

Capricor reported $98.6 million in cash, cash equivalents, and marketable securities as of September 30, 2025, sufficient to fund operations into Q4 2026. The company expects to submit HOPE-3 data as a complete response to the July CRL, targeting a 2026 approval to qualify for a priority review voucher. If approved, a $80 million milestone payment from NS Pharma and potential PRV are anticipated. R&D expenses for Q3 2025 were $18.1 million (excluding stock-based compensation), with full-year 2025 R&D costs projected to exceed $54.4 million. The CEO emphasized disciplined capital allocation, with expenses tied to HOPE-3 completion, commercial readiness, and exosome program advancements, while noting NIAID funding offsets costs for the StealthX platform.

Additional News

Recent developments include the FDA’s signaled regulatory flexibility for Capricor’s Duchenne therapy, which could expedite approval if cardiac efficacy data are strong. The company’s Regenerative Medicine Advanced Therapy (RMAT) designation is highlighted as a potential catalyst, with retail traders viewing it as a “secret weapon” for accelerated approval. Additionally, Capricor’s San Diego GMP facility passed its pre-license inspection, resolving all CMC concerns from the CRL. These updates, combined with the $98.6 million cash runway, position the company for a potential 2026 launch, pending positive HOPE-3 trial results.