Capricor Therapeutics Reports $24.4 Million Net Loss and No Revenue in Q1 2025

Capricor Therapeutics, Inc. reported significant financial results for the first quarter of 2025, revealing a net loss of $24.4 million, compared to a net loss of $9.8 million for the same period in 2024. The company did not generate any revenue during this quarter, a notable decline from the $4.9 million reported in the previous year. This shift is attributed to the completion of milestone revenue recognition from its collaboration with Nippon Shinyaku, which had previously contributed to the revenue figures.

The company's operating expenses surged to $25.0 million in Q1 2025, up from $15.2 million in Q1 2024, driven primarily by increased research and development costs, which rose to $18.9 million from $11.1 million. This increase reflects Capricor's ongoing investment in its lead product candidate, deramiocel, and its exosome platform, as the company prepares for potential commercialization. General and administrative expenses also rose to $6.1 million, up from $4.1 million, largely due to higher personnel costs and stock-based compensation.

Capricor's total assets as of March 31, 2025, were approximately $153.8 million, a decrease from $170.5 million at the end of 2024. The company held $28.8 million in cash and cash equivalents, alongside $116.0 million in marketable securities. The decline in total assets is primarily due to the company's continued investment in clinical trials and operational activities. As of the end of the first quarter, Capricor had an accumulated deficit of $224.2 million.

Strategically, Capricor has made significant progress in its clinical development programs, particularly with deramiocel, which is being evaluated for the treatment of Duchenne muscular dystrophy (DMD). The company has completed its Biologics License Application (BLA) submission to the FDA, which has been accepted for review with a target action date set for August 31, 2025. Additionally, Capricor has entered into multiple distribution agreements with Nippon Shinyaku for the commercialization of deramiocel in the United States and Japan, with potential milestone payments that could significantly impact future revenues.

Looking ahead, Capricor anticipates continued operational losses as it invests heavily in its clinical programs. The company expects to require substantial additional capital to fund its operations and clinical trials, with plans to explore various financing options, including equity and debt financing, as well as potential collaborations. The successful development and commercialization of deramiocel remain critical to Capricor's financial outlook and long-term viability.