Capricor Therapeutics Inc. reported its financial results for the first quarter of 2025, highlighting a significant variation in revenues and net loss compared to the same period in the previous year. The company achieved revenues of $0, a notable decrease from the $4.9 million reported in the first quarter of 2024. This decline is attributed to the complete recognition of milestone payments under the U.S. Distribution Agreement as of December 31, 2024. The net loss for the first quarter of 2025 was approximately $24.4 million, or $0.53 per share, compared to a net loss of $9.8 million, or $0.31 per share, reported in the first quarter of 2024. Total operating expenses increased to approximately $25.0 million from $15.2 million in the previous year. Capricor Therapeutics also provided a corporate update, noting that the Biologics License Application $(BLA.AU)$ for deramiocel in the treatment of Duchenne muscular dystrophy remains under priority review by the U.S. FDA, with a target Prescription Drug User Fee Act (PDUFA) date set for August 31, 2025. The company completed a mid-cycle review meeting with the FDA, which identified no significant deficiencies, and a late-cycle meeting is scheduled for June. Additionally, the FDA has indicated its intent to convene an advisory committee meeting regarding the BLA. Looking ahead, Capricor believes its available cash, cash equivalents, and marketable securities, totaling approximately $145 million, will support planned operations into 2027. The National Institute of Allergy and Infectious Diseases (NIAID) plans to initiate a phase 1 clinical trial of Capricor's StealthX™ exosome vaccine in the third quarter of 2025, pending regulatory approval.
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