Generation Bio Reports Second Quarter 2023 Financial Results
02 Agosto 2023 - 5:15PM
Generation Bio Co. (Nasdaq: GBIO), a
biotechnology company innovating genetic medicines for people
living with rare and prevalent diseases, reported business
highlights and second quarter 2023 financial results.
“We continue to make encouraging progress in the development of
our cell-targeted lipid nanoparticle (ctLNP) technology, which is a
unique, highly specific, non-viral genetic medicine delivery system
for nucleic acid cargoes targeted to the liver as well as non-liver
tissues,” said Geoff McDonough, M.D., chief executive officer of
Generation Bio. “For the remainder of the year, we are focused on
demonstrating Factor VIII expression in non-human primates for our
hemophilia A program as well as continued development of in-vivo
targeting to immune cells with our stealth ctLNPs. These
achievements are important for demonstrating our platform’s
potential to enable a deep pipeline of hepatic programs and broad
portfolios of extrahepatic programs.”
Second Quarter 2023 Financial Results
- Cash
Position: Cash, cash equivalents, and marketable
securities were $314.1 million as of June 30, 2023,
compared to $279.1 million in cash, cash equivalents, and
marketable securities as of December 31, 2022. The company
continues to believe that its cash position will fund its operating
plan into 2025.
- R&D
Expenses: Research and development (R&D) expenses
were $21.8 million for the quarter ended June 30,
2023, compared to $28.4 million for the quarter ended June 30,
2022.
- G&A
Expenses: General and administrative (G&A)
expenses were $13.0 million for the quarter ended June
30, 2023, compared to $10.1 million for the quarter ended June 30,
2022.
- Net Loss: Net loss was $31.1
million, or $0.47 basic and diluted net loss per share, for
the quarter ended June 30, 2023, compared to a net loss of $37.9
million, or $0.66 basic and diluted net loss per share, for the
quarter ended June 30, 2022.
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 cell
types, 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.
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
platform, 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; whether
results from earlier preclinical studies will be predictive of the
results of later preclinical studies and clinical trials;
uncertainties regarding the RES manufacturing process;
uncertainties regarding the company’s ability to assign or sublease
its manufacturing property; 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 ContactMaren
KillackeyGeneration Biomkillackey@generationbio.com857-371-4638
GENERATION BIO
CO.CONSOLIDATED BALANCE SHEET DATA
(Unaudited)(In thousands)
|
|
|
|
|
|
|
Earnings Release
Balance Sheet |
|
June 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and
marketable securities |
|
$ |
314,143 |
|
$ |
279,091 |
Working capital |
|
|
294,144 |
|
|
267,866 |
Total assets |
|
|
404,883 |
|
|
376,264 |
Total stockholders’
equity |
|
|
254,287 |
|
|
282,493 |
GENERATION BIO
CO.CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)(in thousands, except share and
per share data)
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
Collaboration Revenue |
|
$ |
880 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
21,832 |
|
|
|
28,365 |
|
General and administrative |
|
|
12,967 |
|
|
|
10,116 |
|
Total operating expenses |
|
|
34,799 |
|
|
|
38,481 |
|
Loss from operations |
|
|
(33,919 |
) |
|
|
(38,481 |
) |
Other income: |
|
|
|
|
|
|
Other income and interest income, net |
|
|
2,853 |
|
|
|
552 |
|
Net loss and net loss
attributable to common stockholders |
|
$ |
(31,066 |
) |
|
$ |
(37,929 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.47 |
) |
|
$ |
(0.66 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
65,656,151 |
|
|
|
57,149,474 |
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
Net loss |
|
$ |
(31,066 |
) |
|
$ |
(37,929 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized losses on marketable securities |
|
|
(57 |
) |
|
|
(339 |
) |
Comprehensive loss |
|
$ |
(31,123 |
) |
|
$ |
(38,268 |
) |
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