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EX - 99.1 2 fate - ex991_19.htm EX - 99.1 Exhibit 99.1 Fate THERAPEUTICS Fate Therapeutics Reports First Quarter 2021 Financial Results and Highlights Operational Progress IND Application Allowed by FDA for FT538 in Solid Tumors ; Clinical Trial to Commence in 2021 Phase 1 Data from FT516 and FT538 Programs in Relapsed / Refractory Acute Myeloid Leukemia to be Featured at Investor Event on May 13 New Data from FT516 Phase 1 Study in Relapsed / Refractory Lymphoma to be Presented at 2021 American Society of Clinical Oncology Annual Meeting San Diego , CA - May 5 , 2021 – Fate Therapeutics , Inc. ( NASDAQ : FATE ) , a clinical - stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer , today reported business highlights and financial results for the first quarter ended March 31 , 2021 . “ During the first quarter of 2021 , we strengthened our balance sheet by raising $ 460 million and successfully positioned our off - the - shelf , iPSC - derived NK cell pipeline to achieve significant clinical milestones across our disease franchises throughout the remainder of the year . We look forward to sharing Phase 1 clinical data from our FT516 and FT538 programs in relapsed / refractory AML at an investor event to be held alongside the ASGCT conference . We are also pleased with the clinical expansion of our FT538 program into solid tumors , where we plan to combine with FDA - approved monoclonal antibodies targeting EGFR , HER2 , and PDL1 , ” said Scott Wolchko , President and Chief Executive Officer of Fate Therapeutics . " While we are disappointed that the PROTECT study of ProTmune did not meet its primary endpoint for prevention of acute graft - versus - host disease following allogeneic stem cell transplant , we will now turn our full attention and resources to our deep pipeline of off - the - shelf , iPSC - derived cancer immunotherapies . We would like to sincerely thank the patients , caregivers and investigators who participated in the clinical investigation of ProTmune , and we intend to share our clinical findings with that community . " AML Disease Franchise Interim Phase 1 Clinical Data for FT516 and FT538 Programs to be Featured at Upcoming Investor Event . On May 13 , the Company plans to host a virtual investor event to highlight interim Phase 1 clinical data from its FT516 ( hnCD16 engineered iPSC - derived NK cell ) and FT538 ( hnCD16 + IL - 15RF + CD38KO engineered iPSC - derived NK cell ) programs for the treatment of relapsed / refractory acute myeloid leukemia ( AML ) . The Phase 1 study of FT516 as a monotherapy ( NCT04023071 ) has enrolled the first and second dose cohorts ( 90 million and 300 million cells per dose , respectively ) , and dose escalation is ongoing with enrollment in the third dose cohort ( 900 million cells per dose ) . The Phase 1 study of FT538 as a monotherapy ( NCT04614636 ) is enrolling in the first dose cohort ( 100 million cells per dose ) . The Company is also working with investigators from the Masonic Cancer Center , University of Minnesota to