Generation Bio Announces Strategic Reorganization to Extend Cash Runway for Development of ctLNP and iqDNA Platforms
29 Novembro 2023 - 8:59AM
Generation Bio Co. (Nasdaq:GBIO), a biotechnology company
innovating genetic medicines for people living with rare and
prevalent diseases, announced a strategic reorganization to
prioritize investment in the development of its cell-targeted lipid
nanoparticle (ctLNP) delivery system for wholly-owned programs in
extrahepatic cell types. Generation Bio intends to continue to
develop ctLNP for immune cells as part of its collaboration with
Moderna and to develop its immune-quiet DNA (iqDNA) for its lead
hemophilia A and other programs.
“Our ctLNP platform has demonstrated uniquely
selective ligand-targeted delivery to T cells with minimal
off-target uptake. We believe there is a clear path to developing
our own programs using ctLNP to reach extrahepatic targets and are
realigning our investments to support this,” said Geoff McDonough,
M.D., chief executive officer of Generation Bio. “We also remain
focused on developing the iqDNA platform for our lead program in
hemophilia A as well as for other programs in the liver and beyond.
To allow us to reach critical development milestones for these
platforms under current market conditions, we are taking the
difficult but necessary steps to align our investments with our
strategy and to extend our cash runway.”
Dr. McDonough continued: “We are deeply grateful
to all our employees who have demonstrated incredible dedication to
each other, to our community, and to the millions of people whose
lives we aim to significantly improve by pursuing our mission. We
are focused on supporting our departing employees through this
difficult transition, and on beginning the next stage of our
journey.”
The reorganization actions and financial impacts are as
follows:
- Streamlining R&D to develop wholly-owned ctLNP programs for
extrahepatic cell types
- Continuing to develop immune cell programs with Moderna
- Continuing to develop the iqDNA platform for its lead
hemophilia A and other programs
- Extending cash runway into the second half of 2027
The company will reduce its total workforce by 40%, while
preserving core R&D capacity. Several of Generation Bio’s
leadership team members will also depart as part of the
reorganization.
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 novel iqDNA; a unique ctLNP delivery
system; and a highly scalable capsid-free manufacturing process
that uses proprietary cell-free rapid enzymatic synthesis, or RES,
to produce iqDNA. This approach 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 strategic reorganization, the potential cost
savings from the strategic reorganization and the impact of the
strategic reorganization on the company’s cash runway, and 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 as to whether the strategic reorganization will
result in the cost savings expected or the extension of the
company’s cash runway for the period anticipated or have other
impacts on the company’s ability to achieve its strategic goals;
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 the company’s novel technologies; 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; 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 (NASDAQ:GBIO)
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