Applied Genetic Technologies Corporation (Nasdaq: AGTC), a
biotechnology company conducting human clinical trials of
adeno-associated virus (AAV)-based gene therapies for the treatment
of rare diseases, today announced that it has initiated plans to
lease a build-to-suit 21,000 square foot current Good Manufacturing
Practices (cGMP) manufacturing and quality control facility
adjacent to its Florida facility to prepare for anticipated
late-stage development of its X-Linked Retinitis Pigmentosa (XLRP)
and Achromatopsia (ACHM) programs. Build-out of this cGMP facility,
which is expected to be completed in the second half of 2022, is
part of the Company’s strategy to enable more rapid filing of a
Biologics Licensing Application and commercial launch of its XLRP
candidate upon potential United States Food and Drug Administration
(FDA) approval. The cGMP facility is also expected to support more
rapid advancement of the Company’s product pipeline while providing
supply chain redundancy and reducing manufacturing risk.
“This manufacturing build-out reinforces our
commitment to the advancement of our XLRP candidate through a Phase
2/3 clinical trial and, if approved, eventual commercialization. We
are taking steps to increase control over our cGMP manufacturing
and analytical release to ensure that we can meet anticipated
future demand for our current clinical candidates and our exciting
pre-clinical opportunities,” said Sue Washer, President and Chief
Executive Officer of AGTC. “This state-of-the-art manufacturing
facility will provide us with the flexibility to pursue additional
indications that have large patient populations and/or require
substantially higher doses to provide efficacy.”
The Company presented new data from two studies
related to improvements in the manufacturing process for its XLRP
gene therapy candidate on May 11, 2021 at the American Society of
Gene & Cell Therapy (ASGCT) 24th Annual Meeting, which was held
virtually May 11-14, 2021. These improvements will support
manufacturing and quality release for the Phase 2/3 Vista trial by
our current manufacturing partners, and potential late-stage trials
for ACHM as the Company works toward finalizing a commercial
manufacturing process that could meet potential market demand.
On May 6, 2021, AGTC reported new data from its
ongoing Phase 1/2 XLRP clinical trial that further support the
best-in-class potential of its XLRP candidate. The updated data
among patients who met the inclusion criteria for the Skyline and
Vista trials show a 50% response rate in Groups 5 and 6 at month 12
based on improvements in visual sensitivity; a statistically
significant difference with respect to visual acuity in treated
compared with untreated eyes for patients in Groups 2, 4, 5 and 6
and month 12; and continued durability of response at month 24 in
two of three Group 4 patients available for evaluation at the time
point. The complete 12-month data will be presented at the American
Academy of Ophthalmology annual meeting in November 2021 and the
Company remains on track to report 3-month masked interim Skyline
data in the fourth quarter of 2021, 12-month Skyline data in the
third quarter of 2022, and 6-month masked interim Vista the fourth
quarter of 2022.
“We are confident that our expanding body of
data supports the unparalleled potential of our XLRP product
candidate, and we are moving quickly to advance commercialization
plans on multiple fronts,” said David R. Knop, Ph.D., Vice
President of Process Development at AGTC. “We have developed a
robust, reproducible, scalable and highly productive AAV
manufacturing process and associated analytics, which allows for a
modest sized facility to fulfill supply requirements through
commercialization.”
The Company plans to support its cGMP
manufacturing and quality control strategic investment through a
combination of robust tenant improvement allowances and tiered
rental rates during construction of the build-to-suite facility.
Equally as important, on May 13, 2021, the Company amended its Loan
and Security Agreement (the “Loan Agreement”) with Hercules
Capital, Inc. (NYSE: HTGC). Under the amended Loan Agreement, a
second term loan advance of $10.0 million was authorized and
advanced to the Company. Additionally, the interest-only period and
loan maturity date were extended to March 31, 2022 and April 1,
2024, respectively, and, in the event that the Company meets
certain conditions, including achievement of performance
milestones, the Company has the ability to further extend those
dates. The Company also has the right, subject to the lenders’ sole
discretion, to receive additional term loan advances of up to $5.0
million prior to April 1, 2022 or, if certain conditions are
satisfied, then prior to January 1, 2023. All other material terms
of the Loan Agreement were unchanged.
"This additional funding from Hercules Capital
will support AGTC’s investment in internal manufacturing
capabilities, while further advancing its clinical pipeline. We are
pleased to be able to amend our current debt facility and provide
the additional growth capital to support these efforts," said Bryan
Jadot, Senior Managing Director and Life Sciences Group Head for
Hercules.
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 that address
real patient needs. AGTC’s most advanced clinical programs leverage
its best-in-class technology platform to potentially improve vision
for patients with an inherited retinal disease. AGTC has active
clinical trials in X-linked retinitis pigmentosa (XLRP) and
achromatopsia (ACHM CNGB3 and ACHM CNGA3). 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
need in optogenetics, otology and CNS disorders. In recent years
AGTC has entered into strategic partnerships with companies
including Otonomy, Inc., a biopharmaceutical company dedicated to
the development of innovative therapeutics for neurotology,
and Bionic Sight, LLC, an innovator in the emerging field of
optogenetics and retinal coding.
Forward-Looking
Statements This release contains forward-looking
statements that reflect AGTC's plans, estimates, assumptions and
beliefs. Forward-looking statements include information about the
Company’s planned build-to-suit lease, the expected timing for the
build out of the facility and its potential to support early-stage
pipeline programs, possible or assumed future results of
operations, financial guidance, business strategies and operations,
preclinical and clinical product development and regulatory
progress and the expected timing thereof, potential growth
opportunities, potential market opportunities and the effects of
competition. 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: risks related to new construction; 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; 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 Annual Report on Form 10-K for the fiscal
year ended June 30, 2020 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.
AGTC IR/PR CONTACTS: David Carey (IR)
or Glenn Silver (PR)Lazar FINN PartnersT: (212) 867-1768
or (646)
871-8485david.carey@finnpartners.com or
glenn.silver@finnpartners.com
Corporate Contacts:Bill SullivanChief Financial
OfficerApplied Genetic Technologies CorporationT: (617)
843-5728 bsullivan@agtc.com
Stephen PotterChief Business OfficerApplied Genetic Technologies
CorporationT: (617) 413-2754spotter@agtc.com
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