Bay Street News

Generation Bio Reports Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

– Company is leveraging proprietary cell-targeted lipid nanoparticle delivery to develop wholly-owned in vivo program for sickle cell disease and beta-thalassemia

– Development of breakthrough immune-quiet DNA for hemophilia A program continues

– Cash balance of $264.4 million expected to fund operations into 2H 2027

CAMBRIDGE, Mass., March 06, 2024 (GLOBE NEWSWIRE) — Generation Bio Co. (Nasdaq:GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, reported business highlights and fourth quarter and full year 2023 financial results.

“Late last year we announced important advances in our cell-targeted lipid nanoparticle and immune-quiet DNA platforms that we are now translating to our portfolio strategy,” said Geoff McDonough, M.D., chief executive officer of Generation Bio. “The potency and selectivity of our ctLNP platform open up significant opportunities for in vivo delivery of T cell and hematopoietic stem cell therapies, and this year we are laying the foundation for a wholly-owned program in sickle cell disease and beta-thalassemia. We are also continuing to optimize iqDNA to progress our hemophilia A program and to explore therapeutic applications in cell types beyond hepatocytes. With our current cash balance, we believe we have sufficient runway to reach meaningful development milestones for our platforms and programs.”

Business Highlights

Fourth Quarter and Full Year 2023 Financial Results

About Generation Bio

Generation Bio is innovating non-viral genetic medicines to provide durable and redosable treatments for hundreds of millions of patients living with rare and prevalent diseases. The company is developing two distinct and complementary platforms: a potent, highly selective cell-targeted lipid nanoparticle (ctLNP) delivery system and a novel immune-quiet DNA (iqDNA) cargo produced by a scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis (RES). With these platforms, Generation Bio aims to develop the next wave of non-viral genetic medicines 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. 

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the company, including statements about the company’s strategic plans or objectives, cash resources, technology platforms, research and clinical development plans, and preclinical data 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; uncertainties regarding our novel platforms and related technologies; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; 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; as well as the other risks and uncertainties set forth in the “Risk Factors” section of the company’s 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.

Investors and Media Contact
Maren Killackey
Generation Bio
mkillackey@generationbio.com
857-371-4638

GENERATION BIO CO.
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In thousands)
               
Earnings Release Balance Sheet December 31, 2023   December 31, 2022
Cash, cash equivalents and marketable securities $ 264,364     $ 279,091  
Working capital   232,704       267,866  
Total assets   374,758       376,264  
Total stockholders’ equity   203,128       282,493  
               
GENERATION BIO CO.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share and per share data)
 
  Three Months Ended December 31,   Year Ended December 31,
    2023       2022       2023       2022  
Revenues:                              
Collaboration Revenue $ 2,878     $     $ 5,904     $  
                               
Operating expenses:                              
Research and development   27,923       21,607       93,617       96,718  
General and administrative   13,376       13,081       50,850       44,464  
Total operating expenses   41,299       34,688       144,467       141,182  
Loss from operations   (38,421 )     (34,688 )     (138,563 )     (141,182 )
Other income:                              
Other income and interest income, net   3,235       2,283       11,951       4,543  
Net loss $ (35,186 )   $ (32,405 )   $ (126,612 )   $ (136,639 )
Net loss per share, basic and diluted $ (0.53 )   $ (0.55 )   $ (1.96 )   $ (2.35 )
Weighted average common shares outstanding, basic and diluted   66,062,208       59,407,296       64,483,520       58,114,893  
                               
Comprehensive loss:                              
Net loss $ (35,186 )   $ (32,405 )   $ (126,612 )   $ (136,639 )
Other comprehensive income (loss):                              
Unrealized gains (losses) on marketable securities   278       219       357       (83 )
Comprehensive loss $ (34,908 )   $ (32,186 )   $ (126,255 )   $ (136,722 )
                               


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