Financial Performance - Revenues for Q4 2024 were approximately 11.1million,adecreasefrom12.1 million in Q4 2023; total revenues for the year were approximately 22.3million,downfrom25.2 million in 2023[10] - Total operating expenses for Q4 2024 were approximately 18.8million,upfrom13.4 million in Q4 2023; annual operating expenses increased to approximately 64.8millionfrom49.3 million[11] - The net loss for Q4 2024 was approximately 7.1million,or0.16 per share, compared to a net loss of 0.8million,or0.02 per share, in Q4 2023; the annual net loss was approximately 40.5million,or1.15 per share, compared to 22.3million,or0.83 per share, in 2023[12] - Comprehensive loss for the year ended December 31, 2024, was (39,676,044),comparedto(22,156,973) in 2023, indicating a worsening financial performance[26] - The company reported a net loss per share of (0.16)forQ42024,comparedto(0.02) 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,comparedto39.5 million at the end of 2023, reflecting a significant increase in liquidity[9] - Capricor received a 10millionmilestonepaymentfromNipponShinyaku,contributingtoacashbalanceexpectedtosupportoperationsinto2027[9]−Cash,cashequivalents,andmarketablesecuritiesroseto151,515,877 as of December 31, 2024, compared to 39,487,703attheendof2023,indicatingimprovedliquidity[28]AssetsandLiabilities−Totalassetsincreasedto170,481,086 in 2024, up from 58,734,327in2023,reflectingstronggrowthinthecompany′sfinancialposition[28]−Totalliabilitiesdecreasedto25,018,750 in 2024 from 36,132,860in2023,showingareductioninfinancialobligations[28]−Totalstockholders′equityincreasedto145,462,336 in 2024 from 22,601,467in2023,indicatingasignificantimprovementinthecompany′sequityposition[28]ResearchandDevelopment−Researchanddevelopmentexpensesincreasedto14,554,936 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]