Capricor Therapeutics(CAPR) - 2024 Q4 - Annual Results

Financial Performance - 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, down from $25.2 million in 2023[10] - Total operating expenses for Q4 2024 were approximately $18.8 million, up from $13.4 million in Q4 2023; annual operating expenses increased to approximately $64.8 million from $49.3 million[11] - 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; the annual net loss was approximately $40.5 million, or $1.15 per share, compared to $22.3 million, or $0.83 per share, in 2023[12] - Comprehensive loss for the year ended December 31, 2024, was $(39,676,044), compared to $(22,156,973) in 2023, indicating a worsening financial performance[26] - The company reported a net loss per share of $(0.16) for Q4 2024, compared to $(0.02) for Q4 2023, highlighting increased losses on a per-share basis[26] Cash and Liquidity - Capricor reported a cash position of approximately $151.5 million as of December 31, 2024, compared to $39.5 million at the end of 2023, reflecting a significant increase in liquidity[9] - Capricor received a $10 million milestone payment from Nippon Shinyaku, contributing to a cash balance expected to support operations into 2027[9] - Cash, cash equivalents, and marketable securities rose to $151,515,877 as of December 31, 2024, compared to $39,487,703 at the end of 2023, indicating improved liquidity[28] Assets and Liabilities - Total assets increased to $170,481,086 in 2024, up from $58,734,327 in 2023, reflecting strong growth in the company's financial position[28] - Total liabilities decreased to $25,018,750 in 2024 from $36,132,860 in 2023, showing a reduction in financial obligations[28] - Total stockholders' equity increased to $145,462,336 in 2024 from $22,601,467 in 2023, indicating a significant improvement in the company's equity position[28] Research and Development - Research and development expenses increased to $14,554,936 in Q4 2024, up 46% from $9,940,167 in Q4 2023[26] - The company is advancing its StealthX™ exosome-based vaccine for SARS-CoV-2, with plans for regulatory approval in Q2 2025[14] Regulatory Developments - The FDA accepted Capricor's Biologics License Application (BLA) for deramiocel, with a target action date set for August 31, 2025, and granted priority review status[5] - Positive data from the HOPE-2 trial indicated a 52% slowing of disease progression in patients treated with deramiocel over three years[5] - The European Medicines Agency granted deramiocel Orphan Drug and Advanced Therapy Medicinal Product designations, providing market exclusivity and regulatory benefits[6] - Capricor expanded its manufacturing capacity for deramiocel by amending its lease for additional GMP space in San Diego[6]