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Fate Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates
FATEFate Therapeutics(FATE) Newsfilter·2025-03-05 21:01

Core Insights - Fate Therapeutics has initiated Phase 1 dose expansion for its FT819 off-the-shelf CAR T-cell product candidate targeting moderate-to-severe systemic lupus erythematosus (SLE) using a fludarabine-free conditioning regimen [1][3] - The company has completed a Type D meeting with the FDA to expand the clinical investigation of FT819 to additional B cell-mediated autoimmune diseases [4] - As of December 31, 2024, the company reported 307millionincash,cashequivalents,andinvestments,providingaprojectedoperatingrunwaythroughtheendof2026[1][7]ClinicalDevelopment−ThePhase1clinicaltrialforFT819hasbegundoseexpansiontoincludeupto10patientsatadoseof360millioncells,evaluatingsafetyandefficacywithoutfludarabine[3]−InitialclinicaldatafromthefirstthreeSLEpatientstreatedwithFT819showednodose−limitingtoxicitiesandrapideliminationofCD19+Bcells[3]−ThefirstpatienttreatedwithFT819asanadd−ontomaintenancetherapywithoutconditioningchemotherapyalsoshowednoadverseevents[3]RegulatoryEngagement−TheFDAhasallowedtheinclusionofadditionalBcell−mediatedautoimmunediseasesintheFT819Phase1study,withplanstoinitiatedose−expansioncohortsfordiseasessuchasanti−neutrophiliccytoplasmicantibody−associatedvasculitisandsystemicsclerosisin2025[4]−TheFDAhasalsopermittedtheinvestigationofmulti−dosetreatmentcyclesandre−treatmentupondiseaseprogression,aligningtreatmentwithtraditionalbiologicaltherapies[4]FinancialPerformance−Forthefourthquarterof2024,thecompanyreportedtotalrevenueof307 million in cash, cash equivalents, and investments, providing a projected operating runway through the end of 2026 [1][7] Clinical Development - The Phase 1 clinical trial for FT819 has begun dose expansion to include up to 10 patients at a dose of 360 million cells, evaluating safety and efficacy without fludarabine [3] - Initial clinical data from the first three SLE patients treated with FT819 showed no dose-limiting toxicities and rapid elimination of CD19+ B cells [3] - The first patient treated with FT819 as an add-on to maintenance therapy without conditioning chemotherapy also showed no adverse events [3] Regulatory Engagement - The FDA has allowed the inclusion of additional B cell-mediated autoimmune diseases in the FT819 Phase 1 study, with plans to initiate dose-expansion cohorts for diseases such as anti-neutrophilic cytoplasmic antibody-associated vasculitis and systemic sclerosis in 2025 [4] - The FDA has also permitted the investigation of multi-dose treatment cycles and re-treatment upon disease progression, aligning treatment with traditional biological therapies [4] Financial Performance - For the fourth quarter of 2024, the company reported total revenue of 1.9 million, primarily from preclinical development activities [12] - Total operating expenses for the same period were 63.6million,including63.6 million, including 33.6 million in research and development expenses [12] - The net loss for the fourth quarter was 52.2million,withacomprehensivelossof52.2 million, with a comprehensive loss of 52.7 million [14] Product Pipeline - The FT825 program, targeting advanced solid tumors, is advancing into higher-dose cohorts in collaboration with Ono Pharmaceutical [2][8] - Initial clinical data for FT825 indicated a favorable safety profile with no dose-limiting toxicities observed in heavily pre-treated patients [8] - The FT522 program, targeting relapsed/refractory B-cell lymphoma, is also under evaluation for clinical development opportunities in autoimmunity [8]