Earnings release
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LEGEND В І ОТЕСН Legend Biotech Reports Fourth Quarter and Full Year 2020 Financial Results and Business Update March 18 , 2021 • Legend received approximately $ 659.8 million in gross proceeds through share capital increases during 2020 , including a successful Nasdaq IPO with aggregate gross proceeds of $ 487.3 million . • U.S. FDA clearance for IND application for a Phase 1 clinical trial to evaluate LB1901 in relapsed or refractory T - cell lymphoma ( RR TCL ) . • Rolling submission of BLA to the FDA initiated for cilta - cel for the treatment of relapsed or refractory multiple myeloma ( RRMM ) . • Cash and cash equivalents and time deposits of $ 505.7 million as of December 31 , 2020 . SOMERSET , N.J .-- ( BUSINESS WIRE ) -- Mar . 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 three months and year ended December 31 , 2020 . " This was a defining year for Legend Biotech , as we achieved important pipeline advancements and completed our initial public offering and Nasdaq listing , " said Ying Huang , PhD , CEO and CFO of Legend Biotech . " Despite the challenges presented by the COVID - 19 pandemic , we have achieved a strong 2020 and are continuing this momentum with significant advancements planned for our oncology pipeline during 2021. Through our collaboration with Janssen Biotech , Inc. ( Janssen ) * , in 2020 , we initiated a global Phase 3 study and expanded the multi - cohort Phase 2 study as part of a comprehensive clinical development program for ciltacabtagene autoleucel ( cilta - cel ) , including as an earlier lines of multiple myeloma treatment . In 2021 , we expect to achieve important milestones in advancing the regulatory approval process for cilta - cel . " * In December 2017 , Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech , Inc. to develop and commercialize cilta - cel . Fourth Quarter 2020 & Recent Highlights • In February 2021 , the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) accepted a request from Janssen for the accelerated assessment of the cilta - cel Marketing Authorisation Application ( MAA ) for the treatment of adults with RRMM . • In December 2020 , Legend Biotech announced that Janssen had initiated a rolling submission to the U.S. Food and Drug Administration ( FDA ) of a biologics license application ( BLA ) for cilta - cel for the treatment of adults with RRMM . Pursuant to the terms of Legend Biotech's agreement with Janssen , Legend received a $ 75.0 million milestone payment relating to the clinical development of cilta - cel in connection with the initiation of the BLA submission . • In December 2020 , the FDA cleared an investigational new drug ( IND ) application for Legend Biotech to evaluate LB1901 in a Phase 1 clinical study for the treatment of adults with RR TCL . • Data from the combined Phase 1b / 2 CARTITUDE - 1 study of cilta - cel was presented at the 62nd American Society of Hematology ( ASH ) Annual meeting in December 2020 , showing a high overall response rate that deepened over time , with 97 % of patients achieving an overall response and 67 % of patients achieving a stringent complete response ( SCR ) at a median follow - up of 12.4 months . Recent Appointments • During 2020 , Legend Biotech bolstered its leadership team with the appointment of Dr. Ying Huang as Chief Executive Officer , the appointment of Ye ( Sally ) Wang as Chairwoman of the Board of Directors , and the appointment of two new directors , Dr. Li Zhu and Dr. Patrick Casey . • In March 2021 , Lori Macomber was appointed as Legend Biotech's Vice President , Finance , in which capacity Ms. Macomber will serve as Legend Biotech's principal financial officer and principal accounting officer . Ms. Macomber has served as Legend Biotech's Vice President of Supply Chain Finance and Controller since September 2019. Prior to joining Legend Biotech , Ms. Macomber served as Business Unit Controller at Ametek PDS , a leading supplier of components and systems for the aerospace and defense industries , from April 2018 and as U.S. CFO and Controller of Cello Health from March 2017 until February 2018. Before this Ms. Macomber held various positions , most recently AVP Finance Site Leader , at Eli Lilly & Company where she was employed from May 2010 until March 2017. Ms. Macomber holds a Bachelor of Science in Accounting from Pennsylvania State University and is a Certified Public Accountant . • In January 2021 , Lida Pacaud , M.D. , joined Legend Biotech as its Vice President of Clinical Development . Dr. Pacaud , joined Legend Biotech from Novartis International AG , where she held various positions from September 2013 through