Capricor Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - Capricor Therapeutics is advancing towards the market introduction of deramiocel, a cellular therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy, with a Biologics License Application (BLA) accepted by the FDA and a target action date set for August 31, 2025 [2][5][4] Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling approximately $151.5 million, a significant increase from approximately$39.5 million at the end of 2023 [7][25] - Revenues for Q4 2024 were approximately $11.1 million, a decrease from$12.1 million in Q4 2023; total revenues for the year were approximately $22.3 million compared to$25.2 million in 2023 [8] - Total operating expenses for Q4 2024 were approximately $18.8 million, up from$13.4 million in Q4 2023; for the full year, operating expenses were approximately $64.8 million compared to$49.3 million in 2023 [9] - The net loss for Q4 2024 was approximately $7.1 million, or$0.16 per share, compared to a net loss of $0.8 million, or$0.02 per share, in Q4 2023; for the full year, the net loss was approximately $40.5 million, or$1.15 per share, compared to $22.3 million, or$0.83 per share, in 2023 [10][11] Clinical Developments - The FDA has granted priority review for the BLA of deramiocel, which is based on positive data from the HOPE-2 trial showing a 52% slowing of disease progression in treated patients [4][6] - The company has expanded its manufacturing capacity to support the production of deramiocel, with an amendment to its lease for additional GMP space in San Diego [5] - The European Medicines Agency has granted deramiocel Orphan Drug and Advanced Therapy Medicinal Product designations, which provide regulatory advantages and potential market exclusivity [5] Strategic Partnerships - Capricor has an exclusive commercialization and distribution agreement for deramiocel in the U.S. and Japan with Nippon Shinyaku Co., Ltd., which includes milestone payments that have contributed to the company's cash position [20][7]