Capricor Therapeutics (NASDAQ: CAPR) reported a net loss of $105.0 million for the year ended December 31, 2025, compared with a $40.5 million loss in 2024. The company’s cash, cash equivalents and marketable securities rose to $318.1 million, up from $151.5 million at the end of 2024, reflecting a significant capital raise in December 2025.
Operating expenses for 2025 totaled $108.1 million, an increase from $64.8 million in 2024. The rise was driven largely by research and development costs and one‑time items related to the company’s clinical program, including $29.2 million in Q4 operating expenses versus $18.8 million in Q4 2024.
Revenue for 2025 was $0, consistent with the company’s status as a late‑stage clinical company. The $40 million upfront and milestone payments from partner Nippon Shinyaku were fully recognized in 2024, and no additional revenue was generated in 2025.
The company’s cash position now supports operations through 2027, although it remains a going‑concern due to the absence of commercial revenue. Management emphasized that the cash runway provides a buffer for continued investment in the Deramiocel program and regulatory activities.
Capricor’s focus remains on the Deramiocel program, with the FDA’s resubmitted BLA under review and a target action date of August 22, 2026. The company highlighted the potential for milestone payments upon regulatory approval, which could significantly alter its financial outlook.
The Q4 loss of $30.2 million, a 4.3‑fold increase from the $7.1 million loss in Q4 2024, reflects continued investment in clinical development and regulatory activities. EPS for Q4 2025 was $0.62 per share, missing analyst expectations of $0.55 per share by $0.07, a miss that was driven by higher operating expenses and the absence of revenue.
Linda Marbán, CEO, said, "Capricor enters 2026 with important regulatory and clinical momentum as we work toward potential approval of Deramiocel for the treatment of Duchenne muscular dystrophy." She added, "With the FDA review of our BLA underway and a target action date of August 22, 2026, our highest priority is execution, including working closely with the Agency, preparing for potential launch, and continuing to build the capabilities for a commercial‑stage company."
Anthony Bergmann, CFO, noted, "Cash, cash equivalents and marketable securities totaled approximately $318.1 million as of December 31, 2025. Based on our current operating plan, we believe this capital is sufficient to support the business into the fourth quarter of 2027."
Investors reacted to the EPS miss, which was slightly below consensus, but the overall sentiment remained supportive due to the strong regulatory progress on Deramiocel and the company’s robust cash runway. The market’s focus on the regulatory milestone underscores the importance of the FDA review in shaping Capricor’s future revenue prospects.
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