**Capricor Therapeutics Reports Financial Results and Operational Updates**

Capricor Therapeutics, a biotechnology company focused on cell and exosome-based therapeutics, reported its financial results for the year ended December 31, 2025. The company's revenue was $0, a decrease from $22.3 million in 2024, which was primarily due to the completion of revenue recognition related to a milestone payment from Nippon Shinyaku in 2024. The company's research and development expenses increased to $84.5 million in 2025 from $50.0 million in 2024, driven by increased spending on its Duchenne muscular dystrophy (DMD) program, exosome platform research, and facility expenses. General and administrative expenses also increased to $23.7 million in 2025 from $14.9 million in 2024, primarily due to higher stock-based compensation, personnel expenses, and professional service fees.

Capricor's net loss for 2025 was $105.0 million, or $2.26 per share, compared to a net loss of $40.5 million, or $1.15 per share, in 2024. The company's investment income increased to $6.3 million in 2025 from $2.2 million in 2024, due to a higher principal balance in its marketable securities. Interest expense was $3.0 million in 2025, related to interest accrued on a California Institute for Regenerative Medicine (CIRM) award. As of December 31, 2025, Capricor had cash, cash equivalents, and marketable securities totaling $318.1 million, compared to $151.5 million as of December 31, 2024.

Operationally, Capricor's lead product candidate, Deramiocel, for the treatment of DMD, remains under review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. The company submitted a response to the FDA's Complete Response Letter (CRL), which the FDA accepted as a complete response and classified as a Class 2 resubmission. Capricor is also advancing its exosome platform for therapeutic development through internal research, strategic collaborations, and partnerships, including a Phase 1 clinical study with its StealthX™ vaccine in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID).

Looking ahead, Capricor anticipates spending between $100 million and $125 million in 2026 on its Deramiocel program, primarily for manufacturing scale-up, product inventory buildout, clinical, regulatory, and pre-commercial expenses. The company also expects to spend $7 million to $10 million on its exosome platform, including personnel, preclinical studies, and manufacturing-related expenses. Capricor's ability to generate product revenue and achieve profitability is dependent on the successful development, regulatory approval, and commercialization of Deramiocel and its other product candidates.

About CAPRICOR THERAPEUTICS, INC.

Capricor Therapeutics, Inc. is a clinical-stage biotechnology company developing cell and exosome-based therapies, primarily focusing on deramiocel, a cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy. Its proprietary platforms target muscle degeneration and inflammation through immunomodulatory and regenerative mechanisms. Capricor’s business model centers on advancing clinical development, manufacturing, and partnering for commercialization in key markets including the U.S. and Japan.

This description was generated via AI from an annual report. Updated 8 months ago.

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