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Zenas BioPharma Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
ZBIOZenas BioPharma, Inc.(ZBIO) GlobeNewswire News Room·2024-11-12 12:10

Core Insights - Zenas BioPharma completed its initial public offering, raising 258.7milliontosupporttheclinicaldevelopmentofitsleadproductcandidate,obexelimab,anditsgrowthstrategy[1][7]−ThecompanyhasachievedtargetedenrollmentforthePhase3INDIGOtrial,whichisthelargestclinicaltrialforImmunoglobulinG4−RelatedDisease(IgG4−RD),withtoplineresultsexpectedbytheendof2025[2][4]ClinicalDevelopment−ObexelimabisabifunctionalmonoclonalantibodytargetingCD19andFcγRIIb,designedtoinhibittheactivityofBcellsinvolvedinautoimmunediseaseswithoutdepletingthem[3][14]−ThePhase2MoonStonetrialhasbeeninitiatedtoevaluateobexelimab′sefficacyandsafetyinpatientswithRelapsingMultipleSclerosis(RMS),withprimaryendpointresultsexpectedbyQ32025[5]−ThePhase2SunStonetrialisalsounderwaytoassessobexelimabinpatientswithSystemicLupusErythematosus(SLE),withtoplineresultsanticipatedinthefirsthalfof2026[6]−EnrollmentcontinuesinthePhase2SApHiAretrialforwarmAutoimmuneHemolyticAnemia(wAIHA),withinitialdataexpectedlaterthisyear[7]FinancialPerformance−ForQ32024,researchanddevelopmentexpenseswere258.7 million to support the clinical development of its lead product candidate, obexelimab, and its growth strategy [1][7] - The company has achieved targeted enrollment for the Phase 3 INDIGO trial, which is the largest clinical trial for Immunoglobulin G4-Related Disease (IgG4-RD), with topline results expected by the end of 2025 [2][4] Clinical Development - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, designed to inhibit the activity of B cells involved in autoimmune diseases without depleting them [3][14] - The Phase 2 MoonStone trial has been initiated to evaluate obexelimab's efficacy and safety in patients with Relapsing Multiple Sclerosis (RMS), with primary endpoint results expected by Q3 2025 [5] - The Phase 2 SunStone trial is also underway to assess obexelimab in patients with Systemic Lupus Erythematosus (SLE), with topline results anticipated in the first half of 2026 [6] - Enrollment continues in the Phase 2 SApHiAre trial for warm Autoimmune Hemolytic Anemia (wAIHA), with initial data expected later this year [7] Financial Performance - For Q3 2024, research and development expenses were 33.5 million, a significant increase from 9.4millioninQ32023,primarilyduetocostsassociatedwithobexelimab′sclinicaldevelopment[10]−Generalandadministrativeexpensesroseto9.4 million in Q3 2023, primarily due to costs associated with obexelimab's clinical development [10] - General and administrative expenses rose to 7.5 million from 5.0millioninthesameperiodlastyear,attributedtoincreasedpersonnelandoperationalcosts[11]−ThenetlossforQ32024was5.0 million in the same period last year, attributed to increased personnel and operational costs [11] - The net loss for Q3 2024 was 38.6 million, compared to a net income of 35.6millioninQ32023,whichwasinfluencedbycollaborationrevenuefromBristol−MyersSquibb[12][16]CashPosition−AsofSeptember30,2024,thecompany′scashbalancewas35.6 million in Q3 2023, which was influenced by collaboration revenue from Bristol-Myers Squibb [12][16] Cash Position - As of September 30, 2024, the company's cash balance was 386.8 million, including net proceeds of $234.4 million from the IPO, expected to fund operations into Q4 2026 [13][17]