CAMBRIDGE, Mass., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, reported recent business highlights and third quarter 2021 financial results.
“We are building a leading non-viral genetic medicine company with the potential to transform treatments within multiple therapeutic areas,” said Geoff McDonough, M.D., chief executive officer of Generation Bio. “We continue to advance our closed-ended DNA (ceDNA) and next-generation rapid enzymatic synthesis technologies, and plan to provide data on factor VIII expression in non-human primates for our hemophilia A program by year-end. We also continue to develop our cell-targeted lipid nanoparticle (ctLNP) delivery platform, and with the data recently presented at the ESGCT Congress, demonstrated a breakthrough for the retinal field, potentially paving the way for a wave of novel retinal therapies.”
Third Quarter 2021 Financial Results
About Generation Bio
Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The company’s non-viral genetic medicine platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. The platform is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific tissues, and to allow titration and redosing to adjust or extend expression levels in each patient. RES has the potential to expand Generation Bio’s manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.
For more information, please visit www.generationbio.com.
Any statements in this press release about future expectations, plans and prospects for the company, including statements about our strategic plans or objectives, our technology platform, our research and clinical development plans, the expected timing of the submission of investigational new drug, or IND, applications and preclinical data, our manufacturing plans, our expectations regarding our new facility and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials and clinical development of the company’s product candidates; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; uncertainties regarding the timing and ability to complete the build-out of the company’s manufacturing facility and regarding the new manufacturing process; expectations regarding the timing of submission of IND applications; expectations for regulatory approvals to conduct trials or to market products; challenges in the manufacture of genetic medicine products; whether the company’s cash resources are sufficient to fund the company’s operating expenses and capital expenditure requirements for the period anticipated; the impact of the COVID-19 pandemic on the company’s business and operations; as well as the other risks and uncertainties set forth in the “Risk Factors” section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q, which are on file with the Securities and Exchange Commission, and in subsequent filings the company may make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date on which they were made.
Ten Bridge Communications
GENERATION BIO CO.
CONSOLIDATED BALANCE SHEET DATA
|Earnings Release Balance Sheet||September 30, 2021||December 31, 2020|
|Cash, cash equivalents and marketable securities||$||398,363||$||262,327|
|Total stockholders’ equity||407,210||268,013|
GENERATION BIO CO.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|Three Months Ended September 30,|
|Research and development||$||21,991||$||15,308|
|General and administrative||9,667||5,661|
|Total operating expenses||31.658||20,969|
|Loss from operations||(31,658||)||(20,969||)|
|Other (expense) income:|
|Other (expense) and interest income, net||(197||)||120|
|Net loss and net loss attributable to common stockholders||$||(31,855||)||$||(20,849||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.56||)||$||(0.46||)|
|Weighted average common shares outstanding, basic and diluted||56,629,193||45,468,838|
|Other comprehensive loss:|
|Unrealized (losses) gains on marketable securities||(3||)||30|