Capricor 2024 Q4 Earnings Sharp Widening of Losses Amid Regulatory Milestones

Capricor (CAPR) reported its fiscal 2024 Q4 earnings on August 11th, 2025. The results reflect a challenging quarter, with the company posting significantly deeper losses and a modest decline in revenue. The stock has experienced volatile short-term performance, while management continues to emphasize key regulatory progress and long-term strategic execution.

Capricor’s fiscal 2024 Q4 earnings did not meet expectations, with both revenue and net income showing deteriorating trends. The company’s losses widened dramatically, and the stock has faced downward pressure in the short term. Management, however, remains focused on key regulatory milestones and long-term value creation through ongoing clinical trials and product development.

Revenue
Capricor’s total revenue declined by 7.9% year-over-year to $11.13 million in the fourth quarter of 2024, down from $12.09 million in the same period of 2023. This marks a continuation of the company’s revenue challenges, as it remains reliant on its commercial products and grant funding to support its operations.

Earnings/Net Income
Capricor reported a significant widening of its losses, with a net loss of $-7.12 million in Q4 2024—representing an 833.8% increase from the $-762,089 loss in Q4 2023. On a per-share basis, the loss expanded to $0.16 per share, compared to a loss of $0.02 in the prior-year quarter. These results underscore the company’s ongoing financial pressures and the need for continued capital to fund its R&D initiatives.

Price Action
Capricor’s stock has experienced mixed performance in the short term. Over the latest trading day, the stock fell by 4.46%, while it gained 1.76% during the most recent full trading week. However, the month-to-date decline of 31.45% highlights the stock’s vulnerability to market sentiment and regulatory developments.

Post-Earnings Price Action Review
The strategy of buying Capricor (CAPR) shares following the release of its Q4 2024 earnings and holding for 30 days generated a 30.19% return over the past three years. However, this approach underperformed the benchmark by 19.99% and featured a maximum drawdown of 0.00%, a Sharpe ratio of 0.18, and a volatility of 52.18%. Despite its moderate gains, the strategy mirrored the broader market’s volatility and showed limited risk-adjusted performance.

CEO Commentary
Linda Marbán, Ph.D., CEO, emphasized the company’s commitment to delivering the first approved therapy for Duchenne cardiomyopathy. Capricor has made significant regulatory progress, including the resolution of all 483 FDA Pre-License Inspection observations. Marbán outlined the company’s plan to resubmit the Deramiocel BLA based on current data and potentially include upcoming HOPE-3 results, with topline data expected in Q4 2025. She also highlighted the FDA clearance of the StealthX™ IND and the initiation of the Phase 1 trial, underscoring the company’s disciplined execution and long-term strategic focus.

Guidance
Capricor expects to submit a resubmitted BLA for Deramiocel based on existing data, with potential inclusion of HOPE-3 results if regulatory guidance necessitates. The company anticipates topline data from the HOPE-3 Phase 3 trial in Q4 2025, which may serve as supportive evidence for the BLA. The FDA Type A meeting is scheduled for August 2025 to outline the regulatory pathway. The company also expects the StealthX™ Phase 1 trial, funded by NIAID, to initiate dosing imminently. Capricor’s current cash balance of approximately $123 million is expected to support planned operations through Q4 2026.

Additional News
Nigeria requires $120 billion to build federal roads, according to the Trade Union Congress (TUC), highlighting the scale of infrastructure investment needed to support the nation’s growth. Meanwhile, the Federal Government reported generating N5.21 trillion from oil sales in the first half of 2025. In a separate development, marketers have raised petrol prices despite a drop in crude oil costs, drawing public concern over cost management in the energy sector.