AGTC Hosts Topping Off Ceremony for Gene Therapy Manufacturing Facility to Celebrate the Building’s Structural Completion
May 10 2022 - 8:00AM
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a
clinical stage biotechnology company focused on the development of
adeno-associated virus (AAV)-based gene therapies for the treatment
of rare and debilitating diseases with an initial focus on
inherited retinal diseases, recently hosted a topping off ceremony
for its state-of-the-art gene therapy manufacturing facility during
the BioFlorida Celebration of Biotechnology, signaling the
completion of the building’s exterior structure.
“Leasing our own manufacturing facility is an essential part of
our strategy to support the near term production of materials for
upcoming clinical trials and eventually the potential production of
commercial supply for any approved products,” said President and
CEO of AGTC, Sue Washer. “We were thrilled to host this event as
part of BioFlorida’s Celebration of Biotechnology and contribute to
a growing biotech presence in the state. We look forward to the
grand opening later this year and welcoming everyone to the
facility.”
The new manufacturing building is part of the Company’s strategy
to exert more control over its manufacturing needs and enable a
more rapid filing of a Biologics Licensing Application and, if
approved by the FDA, support the commercial launch of its XLRP
candidate. The facility is also expected to support more rapid
advancement of the Company’s product pipeline, providing improved
quality assurance and supply chain redundancy while reducing
manufacturing risk.
The event, held on May 5, began with remarks from BioFlorida’s
President & CEO, Nancy Bryan, Matt Cason, President of Concept
Companies, the project developer, and Sue Washer, President and CEO
of AGTC. The event was attended by many in the local biotech
community as well as the vendors and sub-contractors supporting the
project. To commemorate the event, key members of the project team
signed the last beam to be put in place this week.
About AGTCAGTC is a clinical-stage
biotechnology company developing genetic therapies for people with
rare and debilitating ophthalmic, otologic and central nervous
system (CNS) diseases. AGTC is a leader in designing and
constructing all critical gene therapy elements and bringing them
together to develop customized therapies with the potential to
address unmet patient needs. AGTC’s most advanced clinical programs
leverage its best-in-class technology platform to potentially
improve vision for patients with inherited retinal diseases. AGTC
has active clinical trials in X-linked retinitis pigmentosa (XLRP)
and achromatopsia (ACHM CNGB3). Its preclinical programs build on
the company’s industry leading AAV manufacturing technology and
scientific expertise. AGTC is advancing multiple important pipeline
candidates to address substantial unmet clinical needs in
optogenetics, otology and CNS disorders, and has entered strategic
collaborations with companies including Bionic Sight, an innovator
in the emerging field of optogenetics, and retinal coding and
Otonomy, Inc., a biopharmaceutical company dedicated to the
development of innovative therapeutics for neurotology. For more
information, please visit https://agtc.com/.
Forward-Looking Statements This release
contains forward-looking statements that reflect AGTC's plans,
estimates, assumptions and beliefs, including statements about the
potential of the company’s gene therapy platform, the strength of
its XLRP clinical program, whether clinical trial results will
support future regulatory filings, the expected timing for
completion of the manufacturing facility and the potential for the
new manufacturing facility to support AGTC’s pipeline programs.
Forward-looking statements include all statements that are not
historical facts and can be identified by terms such as
"anticipates," "believes," "could," "seeks," "estimates,"
"expects," "intends," "may," "plans," "potential," "predicts,"
"projects," "should," "will," "would" or similar expressions and
the negatives of those terms. Actual results could differ
materially from those discussed in the forward-looking statements,
due to a number of important factors. Risks and
uncertainties that may cause actual results to differ materially
include, among others: gene therapy is still novel with only a few
approved treatments so far; AGTC cannot predict when or if it will
obtain regulatory approval to commercialize a product candidate or
receive reasonable reimbursement; uncertainty inherent in clinical
trials and the regulatory review process; risks and uncertainties
associated with drug development and commercialization; risks and
uncertainties related to funding sources for our development
programs; the direct and indirect impacts of the ongoing COVID-19
pandemic on the Company’s business, results of operations, and
financial condition; factors that could cause actual results to
differ materially from those described in the forward-looking
statements are set forth under the heading "Risk Factors" in the
company’s most recent annual report on Form 10-K, as it may be
supplemented by subsequent periodic reports filed with
the SEC. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Also, forward-looking
statements represent management's plans, estimates, assumptions and
beliefs only as of the date of this release. Except as required by
law, we assume no obligation to update these forward-looking
statements publicly or to update the reasons actual results could
differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the
future.
PR Contact:
Kerry Sinclair
Spectrum Science Communications
ksinclair@spectrumscience.com
Corporate Contact:
Jonathan Lieber
Chief Financial Officer
Applied Genetic Technologies Corporation
T: (617) 843-5778
jlieber@agtc.com
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