- Planned Doubling of Current DNA Production
Capacity will Enable Company to Support Customers from Early-stage
Drug Discovery Through Late-phase Clinical Trials -
- Expansion Plans Catalyzed by Growing Industry
Demand for LinearDNA™, Repeat and New Proof-of-Concept Orders from
Customers with Long-Term Requirements for cGMP DNA –
- Operational Commencement Expected in 2H
CY2023 -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in PCR-based DNA technologies, announced today plans to
establish a new, separate manufacturing facility to be located in
Suffolk County, New York, for the enzymatic production of cGMP
LinearDNA™ for use in genetic medicines. The expansion plan will
double the Company's production capacity and is being undertaken in
response to the growing number of new nucleic acid-based therapies
under development1 and in the market that are driving greater
demand for high-quality, large-scale therapeutic DNA, as well as a
healthy backlog of repeat and new proof-of-concept orders, the
latter from leading pharma/biotech customers that have expressed a
long-term need for cGMP DNA at scale. Concurrently, the Company is
in active discussions with New York State, local municipalities,
and private entities regarding funding opportunities that may
assist in underwriting the costs of its planned cGMP build-out.
Steve Bellone, the Suffolk County Executive, stated, “Long
Island’s DNA Corridor is the beating heart of the region’s premier
life sciences hub. The advances in medicine being used today to
combat the pandemic that now serve as the basis for mRNA vaccines
were birthed here. The area continues to advance the forefront of
modern medicine with local talent like Applied DNA, whose
enzymatically produced DNA holds the potential to transform human
health. I am pleased to lend my Office’s support to help it reach
its goals for the benefit of us all.”
LinearDNA is produced using the Company’s proprietary LinearDNA
platform, a novel, enzymatic DNA manufacturing approach capable of
rapidly producing high-quality DNA for nucleic acid-based
therapies, including mRNA therapies, cell and gene therapies, and
DNA vaccines. Unlike large and capital-intensive plasmid-based DNA
production facilities, the LinearDNA platform uses bench-top
equipment to rapidly produce DNA in a minimal physical footprint.
The Company’s majority-owned biotherapeutics subsidiary, LineaRx,
Inc., currently serves pharma and biotech companies as a Contract
Research Organization (CRO) with GLP-grade (Good Laboratory
Practices) LinearDNA primarily for research and development
applications.
Upon the planned commencement of operations in the second half
of calendar 2023, the Company’s DNA production capacity will be
approximately 50g/month, a 100% increase over its current monthly
production capacity. The increased capacity will enable the Company
to support customers from early-stage drug discovery through
late-phase clinical trials, subject to necessary regulatory
approvals. The planned cGMP capacity will utilize modular
construction that can be implemented in multiple phases and can be
quickly expanded if warranted by customer demand.
Dr. James A. Hayward, president and CEO of Applied DNA Sciences
and LineaRx, said, “Having cultivated a marquee customer base in
recent years, the gating factor to LinearDNA’s wider adoption has
been our ability to support customers with cGMP-grade product for
clinical trials and commercialization. With today’s announcement,
we embark on a measured and risk-mitigated approach to LinearDNA
scaleup and cGMP aligned with our recent capital raise and industry
trends that are recognizing the value of enzymatic DNA
manufacturing. As demand for enzymatically produced therapeutic DNA
matures, we aim for our growth to be in lockstep with the
industry’s needs.”
About LineaRx, Inc.
LineaRx, an Applied DNA Sciences, Inc. (NASDAQ: APDN) company,
was formed in 2018 to commercialize the parent company's 20+ years
of experience in polymerase chain reaction ('PCR')-based DNA
manufacturing and leadership in enzymatic DNA production. LineaRx
is developing and commercializing the LinearDNA™ platform as a
cell-free enzymatic platform for the largescale DNA manufacture of
high-fidelity DNA sequences for use in nucleic acid-based
therapeutics. DNA manufactured via the platform is free of
adventitious DNA sequences and can be chemically modified to
optimize DNA for specific applications, offering compelling
advantages over plasmid DNA in many biotherapeutic applications,
from mRNA and DNA vaccines to redirected cell and gene therapies.
To learn more about LinearDNA™: click here
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing
technologies to produce and detect deoxyribonucleic acid (“DNA”).
Using PCR to enable both the production and detection of DNA, we
operate in three primary business markets: (i) the manufacture of
DNA for use in nucleic acid-based therapeutics; (ii) the detection
of DNA in molecular diagnostics testing services; and (iii) the
manufacture and detection of DNA for industrial supply chain
security services.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list.
The Company’s common stock is listed on NASDAQ under the ticker
symbol ‘APDN,’ and its publicly traded warrants are listed on OTC
under the ticker symbol ‘APPDW.’
Forward-Looking Statements
The statements made by Applied DNA in this press release may be
“forward-looking” in nature within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform Act of
1995. Forward-looking statements describe Applied DNA’s future
plans, projections, strategies and expectations, and are based on
assumptions and involve a number of risks and uncertainties, many
of which are beyond the control of Applied DNA. Actual results
could differ materially from those projected due to, its history of
net losses, limited financial resources, limited market acceptance,
the uncertainties inherent in research and development, future
clinical data and analysis, including whether any of Applied DNA’s
or its partner’s therapeutic candidates or manufacturing platforms
will advance further in the preclinical research or clinical trial
process, including receiving clearance from the U.S. Food and Drug
Administration (FDA), United State Department of Agriculture (USDA)
or equivalent foreign regulatory agencies to conduct clinical
trials and whether and when, if at all, they will receive final or
conditional approval from the FDA, USDA or equivalent foreign
regulatory agencies, the unknown outcome of any applications or
requests to FDA, USDA or equivalent foreign regulatory agencies,
whether results from preclinical studies will be predictive of the
results of later preclinical studies and clinical trials, the
unknown ability to manufacture therapeutic grade cGMP DNA in large
quantities, the fact that there has never been a commercial drug
product utilizing PCR-produced DNA technology approved for
therapeutic use, the unknown outcome of any applications for local,
municipal or state funding, and various other factors detailed from
time to time in Applied DNA’s SEC reports and filings, including
our Annual Report on Form 10-K filed on December 9, 2021, its
Quarterly Report on Form 10-Q filed on February 10, 2022, May 12,
2022 and August 11, 2022 and other reports it files with the SEC,
which are available at www.sec.gov. Applied DNA undertakes no
obligation to update publicly any forward-looking statements to
reflect new information, events, or circumstances after the date
hereof or to reflect the occurrence of unanticipated events, unless
otherwise required by law.
1 ASGCT Q2 2022 Gene, Cell and RNA Therapies Report.
https://asgct.org/global/documents/asgct-pharma-intelligence-quarterly-report-draft-q.aspx
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version on businesswire.com: https://www.businesswire.com/news/home/20221024005556/en/
Corporate: Investor Relations: Sanjay M. Hurry,
917-733-5573, sanjay.hurry@adnas.com Program: Brian
Viscount, 631-240-8877, brian.viscount@adnas.com Web:
www.adnas.com Twitter: @APDN
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