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Vaxart Provides Business Update and Reports Full Year 2024 Financial Results
VXRTVaxart(VXRT) GlobeNewswire·2025-03-20 20:01

Core Insights - Vaxart, Inc. has initiated a Phase 1 clinical trial for its second-generation oral norovirus vaccine, with topline data expected by mid-2025 [1][5] - The company reported a net loss of 66.9millionforthefullyear2024,animprovementfromanetlossof66.9 million for the full year 2024, an improvement from a net loss of 82.5 million in 2023, with revenue increasing to 28.7millionfrom28.7 million from 7.4 million [12][20] - Vaxart's cash, cash equivalents, and investments totaled 51.7millionasofDecember31,2024,providingafinancialrunwayintothefourthquarterof2025[1][12]NorovirusVaccineDevelopments−ThePhase1trialforthesecond−generationoralnorovirusvaccineconstructsisdesignedtocomparesafetyandimmuneresponsesagainstthefirst−generationconstructs[5]−Ifsuccessful,aPhase2bsafetyandimmunogenicitystudycouldbegininthesecondhalfof2025,followedbyapotentialPhase3trialin2026[5]−DatafromacompletedPhase1btrialofthefirst−generationvaccineinelderlyadultsshowedstrongantibodyresponses,supportingitsimmunogenicity[5]COVID−19VaccineDevelopments−Vaxart′sCOVID−19Phase2btrialhascompletedenrollmentofa400−personsentinelcohort,withparticipantsmonitoredforupto12monthspost−vaccination[12]−AnindependentDataSafetyMonitoringBoardrecommendedproceedingwiththestudybasedoninitialsafetyassessments[5]−AstopworkorderwasissuedinFebruary2025,limitingactivitiesontheCOVID−19trial,butfollow−upworkforthesentinelcohortcancontinue[5][6]InfluenzaProgramDevelopments−Vaxartisadvancingitsavianinfluenzaprogramandhascreatedanewvaccinecandidatetocoverthelatestclade2.3.4.4b[7]−Preclinicalstudiesarebeingconductedtoevaluatethenewconstruct,withresultsexpectedtobepublisheduponcompletion[7]CorporateUpdate−InJanuary2025,VaxartappointedKevinFinneytoitsBoardofDirectors,bringingextensivehealthcareleadershipexperience[8]FinancialResults−Forthefullyear2024,Vaxartreportedrevenueof51.7 million as of December 31, 2024, providing a financial runway into the fourth quarter of 2025 [1][12] Norovirus Vaccine Developments - The Phase 1 trial for the second-generation oral norovirus vaccine constructs is designed to compare safety and immune responses against the first-generation constructs [5] - If successful, a Phase 2b safety and immunogenicity study could begin in the second half of 2025, followed by a potential Phase 3 trial in 2026 [5] - Data from a completed Phase 1b trial of the first-generation vaccine in elderly adults showed strong antibody responses, supporting its immunogenicity [5] COVID-19 Vaccine Developments - Vaxart's COVID-19 Phase 2b trial has completed enrollment of a 400-person sentinel cohort, with participants monitored for up to 12 months post-vaccination [12] - An independent Data Safety Monitoring Board recommended proceeding with the study based on initial safety assessments [5] - A stop work order was issued in February 2025, limiting activities on the COVID-19 trial, but follow-up work for the sentinel cohort can continue [5][6] Influenza Program Developments - Vaxart is advancing its avian influenza program and has created a new vaccine candidate to cover the latest clade 2.3.4.4b [7] - Preclinical studies are being conducted to evaluate the new construct, with results expected to be published upon completion [7] Corporate Update - In January 2025, Vaxart appointed Kevin Finney to its Board of Directors, bringing extensive healthcare leadership experience [8] Financial Results - For the full year 2024, Vaxart reported revenue of 28.7 million, primarily from government contracts related to BARDA [12][20] - Research and development expenses increased to 74.2million,drivenbyclinicaltrialcostsfortheCOVID−19vaccineandotherdevelopmentactivities[12][20]−Generalandadministrativeexpensesdecreasedto74.2 million, driven by clinical trial costs for the COVID-19 vaccine and other development activities [12][20] - General and administrative expenses decreased to 20.8 million, reflecting reduced personnel-related costs [12][20]