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Capricor Therapeutics(CAPR) - 2024 Q4 - Annual Results

Financial Performance - Revenues for Q4 2024 were approximately 11.1million,adecreasefrom11.1 million, a decrease from 12.1 million in Q4 2023; total revenues for the year were approximately 22.3million,downfrom22.3 million, down from 25.2 million in 2023[10] - Total operating expenses for Q4 2024 were approximately 18.8million,upfrom18.8 million, up from 13.4 million in Q4 2023; annual operating expenses increased to approximately 64.8millionfrom64.8 million from 49.3 million[11] - The net loss for Q4 2024 was approximately 7.1million,or7.1 million, or 0.16 per share, compared to a net loss of 0.8million,or0.8 million, or 0.02 per share, in Q4 2023; the annual net loss was approximately 40.5million,or40.5 million, or 1.15 per share, compared to 22.3million,or22.3 million, or 0.83 per share, in 2023[12] - Comprehensive loss for the year ended December 31, 2024, was (39,676,044),comparedto(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)forQ42024,comparedto(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 151.5millionasofDecember31,2024,comparedto151.5 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 10millionmilestonepaymentfromNipponShinyaku,contributingtoacashbalanceexpectedtosupportoperationsinto2027[9]Cash,cashequivalents,andmarketablesecuritiesroseto10 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 39,487,703attheendof2023,indicatingimprovedliquidity[28]AssetsandLiabilitiesTotalassetsincreasedto39,487,703 at the end of 2023, indicating improved liquidity[28] Assets and Liabilities - Total assets increased to 170,481,086 in 2024, up from 58,734,327in2023,reflectingstronggrowthinthecompanysfinancialposition[28]Totalliabilitiesdecreasedto58,734,327 in 2023, reflecting strong growth in the company's financial position[28] - Total liabilities decreased to 25,018,750 in 2024 from 36,132,860in2023,showingareductioninfinancialobligations[28]Totalstockholdersequityincreasedto36,132,860 in 2023, showing a reduction in financial obligations[28] - Total stockholders' equity increased to 145,462,336 in 2024 from 22,601,467in2023,indicatingasignificantimprovementinthecompanysequityposition[28]ResearchandDevelopmentResearchanddevelopmentexpensesincreasedto22,601,467 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]