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EX - 99.1 2 tmb - 20210811xex99d1.htm EX - 99.1 generatiohibit 99.1 Generation Bio Reports Business Highlights and Second Quarter 2021 Financial Results CAMBRIDGE , MASS . , Aug. 11 , 2021 -- Generation Bio Co. ( Nasdaq : GBIO ) , a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases , reported recent business highlights and second quarter 2021 financial results . " This quarter we announced our shift to rapid enzymatic synthesis , or RES , for production of our closed - ended DNA , ceDNA , constructs and our signing of a lease to establish significant internal current Good Manufacturing Practice , or cGMP , manufacturing capacity . These are important steps toward our goal of extending the reach of our durable , redosable genetic medicines to patients with prevalent diseases , " said Geoff McDonough , M.D. , chief executive officer of Generation Bio . “ We will continue to advance the platform throughout the rest of the year and expect factor VIII expression data with ceDNA produced using RES in non - human primates for our hemophilia A program by year - end . ” Business Highlights Transition of Portfolio to Next - Generation Rapid Enzymatic Manufacturing Process Underway : In July 2021 , Generation Bio announced plans to deploy next - generation RES for manufacturing its closed - ended DNA ( ceDNA ) constructs across all portfolio programs . The company also signed a lease agreement to build out a state - of - the - art cGMP facility of approximately 104,000 square feet in Waltham , Mass . to scale RES for clinical and initial commercial supply . The facility is expected to be operational in 2023 , enabling an Investigational New Drug ( IND ) application and clinical development for the company's lead program in hemophilia A. The company is using its existing infrastructure for current production of research material using RES . As Generation Bio transitions to RES , it expects to update its program development strategy and timelines for its pipeline . Second Quarter 2021 Financial Results • Cash Position : Cash , cash equivalents and marketable securities were $ 425.2 million as of June 30 , 2021 , compared with $ 262.3 million as of December 31 , 2020 . • • • R & D Expenses : Research and development ( R & D ) expenses were $ 22.7 million for the quarter ended June 30 , 2021 , compared to $ 13.5 million for the quarter ended June 30 , 2020 . G & A Expenses : General and administrative ( G & A ) expenses were $ 8.2 million for the quarter ended June 30 , 2021 , compared to $ 4.3 million for the quarter ended June 30 , 2020 . Net Loss : Net loss was $ 30.8 million , or $ 0.55 basic and diluted net loss per share , for the quarter ended June 30 , 2021 , compared to a net loss of $ 17.7 million , or $ 1.50 basic