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Humacyte Announces First Quarter 2025 Financial Results and Provides Business Update
HUMAHumacyte(HUMA) GlobeNewswire News Room·2025-05-13 11:30

Core Insights - Humacyte, Inc. has successfully launched its product Symvess™ for treating extremity vascular trauma, marking a significant milestone for the company [2][3] - The company reported total revenues of 517,000forthefirstquarterof2025,with517,000 for the first quarter of 2025, with 147,000 from the initial commercial sales of Symvess and 370,000fromaresearchcollaboration[9][27]−Humacytecompletedapublicofferingthatraised370,000 from a research collaboration [9][27] - Humacyte completed a public offering that raised 46.7 million in net proceeds, which will help extend its cash runway [6][9] Market Launch and Sales - The commercial launch of Symvess began in late February 2025, with initial shipments to three Level 1 trauma centers [3] - 45 hospitals have initiated the Value Analysis Committee (VAC) approval process for Symvess, with five hospitals already approving its purchase [2][3] - The company anticipates further approvals and sales growth in the upcoming quarters [3] Financial Performance - The first quarter of 2025 saw a revenue increase to 517,000comparedtonorevenueinthesameperiodof2024[9][27]−Researchanddevelopmentexpensesdecreasedto517,000 compared to no revenue in the same period of 2024 [9][27] - Research and development expenses decreased to 15.4 million from 21.3millionyear−over−year,attributedtoreducedmaterialcostsandclinicalstudyexpenses[9][27]−Generalandadministrativeexpensesroseto21.3 million year-over-year, attributed to reduced material costs and clinical study expenses [9][27] - General and administrative expenses rose to 8.1 million from 5.3million,primarilyduetothecostsassociatedwiththecommerciallaunchofSymvess[9][27]CostManagementandFuturePlans−Thecompanyimplementedcostreductionmeasures,includingworkforcereductionsanddeferringnewhires,aimingforestimatedsavingsofapproximately5.3 million, primarily due to the costs associated with the commercial launch of Symvess [9][27] Cost Management and Future Plans - The company implemented cost reduction measures, including workforce reductions and deferring new hires, aiming for estimated savings of approximately 13.8 million in 2025 and up to 38millionin2026[6][9]−HumacyteplanstofileanInvestigationalNewDrug(IND)applicationwiththeFDAforthesmall−diameterATEV™incoronaryarterybypassgrafting(CABG)laterthisyear[2][8]−ThecompanyisontracktosubmitasupplementalBiologicsLicenseApplication(BLA)forATEVindialysisin2026,followingamajorenrollmentmilestoneinitsPhase3trial[2][8]CorporateDevelopments−HumacytewasissuedanewU.S.patentinJanuary2025,providingprotectionforitsbiomanufacturingplatformuntil2040[4]−Thecompanyreportedanetincomeof38 million in 2026 [6][9] - Humacyte plans to file an Investigational New Drug (IND) application with the FDA for the small-diameter ATEV™ in coronary artery bypass grafting (CABG) later this year [2][8] - The company is on track to submit a supplemental Biologics License Application (BLA) for ATEV in dialysis in 2026, following a major enrollment milestone in its Phase 3 trial [2][8] Corporate Developments - Humacyte was issued a new U.S. patent in January 2025, providing protection for its biomanufacturing platform until 2040 [4] - The company reported a net income of 39.1 million for the first quarter of 2025, a significant improvement from a net loss of 31.9millioninthesameperiodof2024[17][27]−AsofMarch31,2025,Humacytehadcash,cashequivalents,andrestrictedcashtotaling31.9 million in the same period of 2024 [17][27] - As of March 31, 2025, Humacyte had cash, cash equivalents, and restricted cash totaling 113.2 million [17][28]