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THERAPEUTICS Allogene Therapeutics Reports Third Quarter 2021 Financial Results and Business Update November 4 , 2021 • New Clinical Data from the ALPHA , ALPHA2 and UNIVERSAL AlloCAR TTM Trials to be Presented at the 63rd Annual Meeting of the American Society of Hematology • ALPHA2 Study Abstract Selected for Oral Presentation Highlights the Benefits of Consolidation Dosing with ALLO - 501A in Patients with Relapsed / Refractory Large B Cell Lymphoma • ALPHA Study Abstract Selected for Poster Presentation Continues to Show Durability of Responses to ALLO - 501 in Patients with Non - Hodgkin Lymphoma • UNIVERSAL Study Abstract Selected for Oral Presentation Reports Meaningful Activity of a Single Dose of ALLO - 715 in Patients with Relapsed / Refractory Multiple Myeloma • Discussions Ongoing as Company Seeks to Resolve FDA Clinical Hold • Ended Third Quarter with $ 862 Million in Cash , Cash Equivalents and Investments • Conference Call and Webcast Scheduled for 2:00 PM PT / 5 : 00 PM ET SOUTH SAN FRANCISCO , Calif . , Nov. 04 , 2021 ( GLOBE NEWSWIRE ) -- Allogene Therapeutics , Inc. ( Nasdaq : ALLO ) , a clinical - stage biotechnology company pioneering the development of allogeneic CAR T ( AlloCAR TT ) therapies for cancer , today provided a corporate update and reported financial results for the quarter ended September 30 , 2021 . " While our clinical studies are on hold , our work to bring AlloCAR T products to patients continues with a strong sense of urgency . We remain confident in our platform and the potential of our AlloCAR T candidates to meaningfully improve the lives of patients living with cancer , " said David Chang , M.D. , Ph.D. , President , Chief Executive Officer and Co - Founder of Allogene . " Our teams are busy progressing our preclinical programs , advancing production at our Cell Forge 1 manufacturing facility , and preparing for data presentations at the American Society of Hematology ( ASH ) Annual Meeting in December . In the meantime , we continue to work closely with the U.S. Food and Drug Administration ( FDA ) on the review of the end of Phase 1 materials in support of a pivotal trial for ALLO - 501A as well as to resolve the clinical hold and we look forward to providing an update after further interaction with the agency . " Pipeline Updates The FDA placed a hold on the Company's AlloCAR T clinical trials ( ALPHA , ALPHA2 , IGNITE , TRAVERSE , UNIVERSAL ) following a report of a chromosomal abnormality in a single patient treated in the ALPHA2 study . Allogene is working with the FDA to address next steps to resolve the hold . • In parallel with the clinical hold investigation , the FDA is actively reviewing the end of Phase 1 materials the Company submitted in support of the pivotal trial for ALLO - 501 A. Anti - CD19 Program : ALPHA and ALPHA2 Trials • Abstracts from the ALPHA ( poster session ) and ALPHA2 ( oral session ) trials were selected for presentation at the ASH meeting in early December . The data contained in the abstracts continue to show the utility of AlloCAR T therapy in patients with relapsed / refractory non - Hodgkin lymphoma . Updated results will be presented at the meeting . • In the ALPHA2 trial , consolidation dosing appeared to be well tolerated with the potential for enhanced efficacy compared to a single dose of ALLO - 501A . In the consolidation cohort , both the overall response rate ( ORR ) and complete response ( CR ) rate were 67 % with all three partial responses ( PRs ) converting to CR following consolidation . All four consolidation patients who achieved a CR remained in CR as of the July 2021 data cut - off . The safety profile of ALLO - 501A was manageable in both single dose and consolidation cohorts . Events of interest in the single dose cohort were previously reported at the 2021 American Society of Clinical Oncology ( ASCO ) Annual Meeting . In the consolidation cohort , there was no cytokine release syndrome ( CRS ) , no graft - versus - host disease ( GvHD ) , no immune effector cell - associated neurotoxicity syndrome ( ICANS ) , no dose - limiting toxicities ( DLTs ) , no dose reductions , no Grade 3+ infections and infusion - related reactions were Grade 2. Among all treated patients , cytopenias were the most common adverse event and occurred in 72 % of patients . • In the ALPHA trial as of the July data cutoff for the ASH abstract , five additional patients were treated relative to the data previously reported at the 2021 ASCO Annual Meeting . ORR and CR rates remain at 75 % and 50 % , respectively . In patients with LBCL ( n = 13 ) , the ORR was 62 % and the CR rate was 46 % . In patients with FL ( n = 23 ) , the ORR was 83 % and the CR rate was 52 % . Four of the seven patients ( all FL ) enrolled in the consolidation cohort were evaluable for assessment after consolidation dosing at the time of the data cutoff with an ORR and CR rate of 100 % and 75 % ,