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LEGEND BIOTECH Legend Biotech Reports Second Quarter 2021 Financial Results and Recent Highlights August 23 , 2021 • Investigational BCMA CAR - T therapy ciltacabtagene autoleucel ( cilta - cel ) granted priority review by the U.S. Food and Drug Administration for the treatment of relapsed or refractory multiple myeloma ( RRMM ) • A Marketing Authorisation Application ( MAA ) was accepted by the European Medicines Agency ( EMA ) for cilta - cel for the treatment of RRMM • New and updated cilta - cel data presented at the 2021 American Society of Clinical Oncology ( ASCO ) Annual Meeting and European Hematology Association ( EHA ) Virtual Congress • New investment announced for facility in Belgium , expanding global presence for cell therapy manufacturing SOMERSET , N.J .-- ( BUSINESS WIRE ) -- Aug . 23 , 2021-- Legend Biotech Corporation ( NASDAQ : LEGN ) ( Legend Biotech ) , a global clinical - stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications , today reported its 2021 second quarter unaudited financial results . " We have made exciting progress in advancing our first investigational CAR - T therapy cilta - cel in the past few months , with key regulatory , data and manufacturing updates . This includes the acceptance of our applications for cilta - cel by the U.S. Food and Drug Administration ( FDA ) and European Medicines Agency ( EMA ) and the presentation of additional efficacy and safety data from the CARTITUDE cilta - cel clinical development program at ASCO and EHA Annual meetings , " said Ying Huang , PhD , CEO and CFO of Legend Biotech . " We look forward to a momentous second half of the year as we work towards bringing cilta - cel to patients living with multiple myeloma and providing their healthcare providers a new therapeutic option , in collaboration with Janssen . " Second Quarter 2021 Highlights • In May 2021 , the rolling submission of the Biologics License Application ( BLA ) was accepted by the U.S. FDA for cilta - cel for the treatment of adults with relapsed or refractory multiple myeloma ( RRMM ) , following the submission by Legend Biotech's collaborator , Janssen Biotech , Inc. ( Janssen ) . As part of the BLA acceptance , the FDA granted cilta - cel priority review and set the Prescription Drug User Fee Act ( PDUFA ) target action date for November 29 , 2021 . • In May 2021 , the Marketing Authorisation Application ( MAA ) submitted by Janssen was accepted by the European Medicines Agency ( EMA ) for cilta - cel for the treatment of adults with RRMM . • In addition , a submission for cilta - cel was made to the Brazilian Health Regulatory Agency by Janssen in April 2021 . • Longer term data from the CARTITUDE - 1 trial of cilta - cel in 97 heavily pretreated patients with RRMM , which was presented at the 2021 ASCO and EHA Annual meetings , showed 98 percent overall response rate , 80 percent stringent complete response rate ( SCR ) , progression free survival rate of 66 percent and an overall survival ( OS ) rate of 81 percent at the 18 - month follow - up . A full manuscript containing earlier data from the CARTITUDE - 1 trial at 12.4 - months of follow up was published in The Lancet in June 2021 . • First results from Cohort A of the CARTITUDE - 2 study of cilta - cel , which was featured at the 2021 ASCO and EHA Annual meetings , showed early and deep responses in the cohort of 20 patients with progressive MM after 1-3 prior lines of therapy , and who were lenalidomide refractory , with a safety profile consistent with what has been observed in the CARTITUDE clinical development program . • On June 22 , 2021 , Legend Biotech announced the establishment of a state - of - the - art manufacturing facility in Belgium as part of a joint investment with Janssen , to expand global manufacturing capacity of innovative cellular therapies . • On May 21 , 2021 , Legend Biotech completed the sale of 20,809,805 ordinary shares in a private placement at a purchase price of $ 14.41625 per ordinary share ( equivalent to $ 28.8325 per American Depositary Share , or ADS ) and the issuance of a warrant exercisable for up to an aggregate of 10,000,000 ordinary shares , exercisable for a two - year period at an exercise price of $ 20.00 per ordinary share ( equivalent to $ 40.00 per ADS ) , in each case , pursuant to a subscription agreement dated May 13 , 2021 , with an institutional investor . • In June 2021 , the CARTITUDE clinical program expanded to include the initiation of the CARTITUDE - 5 study ( NCT04923893 ) , a Phase 3 randomized study evaluating cilta - cel in patients with newly diagnosed MM ( NDMM ) for whom autologous stem cell transplant ( ASCT ) is not planned as initial therapy . The CARTITUDE - 5 study will evaluate bortezomib , lenalidomide and dexamethasone , known as VRd , followed by cilta - cel versus VRd , followed by lenalidomide and dexamethasone , or Rd , maintenance therapy . • The ongoing Phase 2 CARTITUDE - 2 study ( NCT04133636 ) was expanded with the addition of two cohorts : Cohort E ( high - risk NDMM , transplant not planned ) and Cohort F ( standard - risk NDMM ) . • In May 2021 , Legend Biotech achieved a $ 15 million milestone payment related to a cilta - cel development milestone ,