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LEGEND В І ОТЕСН Legend Biotech Reports First Quarter 2021 Financial Results and Recent Highlights May 18 , 2021 • Rolling submission of BLA to the FDA completed for ciltacabtagene autoleucel ( cilta - cel ) for the treatment of relapsed or refractory multiple myeloma ( RRMM ) • European Marketing Authorisation Application ( MAA ) submitted for cilta - cel for the treatment of RRMM • New and updated cilta - cel data to be presented at the upcoming 2021 American Society of Clinical Oncology ( ASCO ) Annual Meeting and European Hematology Association ( EHA ) Virtual Congress SOMERSET , N.J .-- ( BUSINESS WIRE ) -- May 18 , 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 unaudited financial results for the first quarter of 2021 . " We built on the momentum of 2020 during the first quarter of this year for our BCMA CAR - T therapy cilta - cel with our collaboration partner , Janssen Biotech , Inc . * ( Janssen ) , completing the Biologics License Application to the U.S. FDA and the Marketing Authorisation Application to the EMA , " said Ying Huang , PhD , CEO and CFO of Legend Biotech . " We look forward to an exciting year with new and updated data from the CARTITUDE clinical development program and reaching our goal of bringing a new CAR - T treatment option to patients living with multiple myeloma worldwide pending regulatory approvals . " * In December 2017 , Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech , Inc. to develop and commercialize cilta - cel . First Quarter 2021 & Recent Highlights • In the first quarter of 2021 , the rolling submission of a Biologics License Application ( BLA ) to the U.S. Food and Drug Administration ( FDA ) was completed by Legend Biotech's collaborator , Janssen , for cilta - cel , for the treatment of adults with RRMM . • On April 30 , 2021 the Marketing Authorisation Application ( MAA ) to the European Medicines Agency ( EMA ) was made by Legend Biotech's collaborator , Janssen , for cilta - cel for the treatment of adults with RRMM . This follows the granting of an accelerated assessment for this MAA by the EMA's Committee for Medicinal Products for Human Use ( CHMP ) in February 2021 . • On May 13 , 2021 , Legend Biotech entered into a subscription agreement with an institutional investor for the offer and 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 ) . Key Upcoming Milestones • Updated clinical data , including longer term follow up results from the CARTITUDE - 1 trial , will be presented at the virtual 2021 ASCO Annual Meeting taking place on June 4-8 , 2021 ( oral presentation , abstract # 8005 ) along with initial data from the CARTITUDE - 2 trial ( abstracts # 8013 , # 8028 ) . In addition , there will be three poster presentations featuring real - world data ( abstracts # 8045 , # 8030 and # 8041 ) . • Nine abstracts will be presented at the European Hematology Association Virtual Congress taking place virtually on June 9-17 , 2021. ( abstracts # S190 , # EP964 , # EP1003 , # EP987 , # EP990 , # EP1049 , # EP978 , # EP977 and # EP972 ) . • Legend Biotech intends to use the data from the CARTIFAN - 1 study in support of a regulatory submission to the China Center for Drug Evaluation ( CDE ) in the second half of 2021 seeking approval of cilta - cel for the treatment of adults with RRMM . • Legend Biotech's collaboration partner , Janssen , anticipates submitting a New Drug Application ( NDA ) to the Japan Ministry of Health , Labor and Welfare ( JMHLW ) in the second half of 2021 seeking approval of cilta - cel for the treatment of adults with RRMM . . • Legend Biotech expects to initiate its Phase 1 clinical trial of LB1901 in RR T - cell lymphoma ( TCL ) in the United States in 2021 . Legend Biotech anticipates supporting investigators with publishing a clinical data update from LEGEND - 2 study in 2021 . Financial Results for First Quarter Ended March 31 , 2021