Applied DNA Achieves Milestone for Large-Scale linearDNA™ Production, Delivers Largest Single Shipment by Volume to Date
March 29 2023 - 9:00AM
Business Wire
Applied DNA Sciences, Inc. (NASDAQ:
APDN) (the “Company”), a leader in PCR-based DNA technologies,
today announced that it has established a new high bar for the
production of DNA with the manufacture and shipment of a multi-gram
quantity of linearDNA™ in under six weeks. The quantity was
produced by the Company’s LinearDNA™ platform under a large
recurring purchase order with a global manufacturer of in vitro
diagnostics that was announced in the first quarter of fiscal 2023
and is the largest single shipment of linearDNA to date. The
Company expects to ship a final multi-gram quantity in the third
fiscal quarter of 2023 to fulfill the purchase order earlier than
contractually stipulated.
“We believe that this production milestone underscores our
LinearDNA platform’s capacity for the rapid, enzymatic production
of DNA at very large scale that stands in stark contrast to the
scalability bottlenecks and challenges associated with conventional
plasmid DNA to support both high value biotherapeutic and lower
price-point diagnostic applications,” stated Dr. James A. Hayward,
president and CEO of Applied DNA Sciences. “Building on our
platform’s inherent advantages of speed and scale, we are
concurrently pursuing platform optimizations and a timeline to cGMP
(current Good Manufacturing Practices) that we believe will enhance
linearDNA’s standing as an alternative source of DNA. The future of
our LinearDNA platform will have it supplying the needs of the
entire DNA demand curve, from GLP-grade (Good Laboratory Practices)
product for in vitro diagnostics and biotherapeutic research and
development to cGMP-grade, therapeutic DNA as a direct replacement
for plasmid DNA-reliant nucleic acid-based therapies.”
The Company’s LinearDNA platform is focused on empowering the
next generation of nucleic acid-based therapies. The platform uses
a cell-free, enzymatic approach that confers the advantages of
simplicity, purity, speed, flexibility, and scalability in a
fractional footprint relative to conventional plasmid DNA
(fermentation)-based manufacturing processes. The resultant DNA,
known as linearDNA™, is currently produced at GLP-grade in volumes
from micrograms to grams to support customers’ needs. The Company
is pursuing a timeline for cGMP linearDNA production that will
enable it to support customers from research and development and
drug discovery through large-scale manufacturing for clinical
trials and commercial use. Learn more about linearDNA at
www.linearrxdna.com
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
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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, unknown future demand for
its biotherapeutics products and services, the unknown amount of
revenues and profits that will result from any customer order for
linearDNA or any linearDNA-based therapeutic, whether any of
Applied DNA’s or its customers therapeutic candidates will advance
further in the preclinical research or clinical trial process,
including receiving clearance from the U.S. Food and Drug
Administration (FDA), the U.S. Department of Agriculture (USDA) or
equivalent foreign regulatory agencies to conduct clinical trials
and whether and when, if at all, they will receive final approval
as therapeutic products from the FDA, the USDA or equivalent
foreign regulatory agencies, the fact that there has never been a
commercial drug product utilizing PCR-produced DNA technology
approved for therapeutic use, and various other factors detailed
from time to time in Applied DNA’s SEC reports and filings,
including its Annual Report on Form 10-K filed on December 14,
2022, as amended, its Form 10-Q filed on February 9, 2023, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230329005314/en/
Corporate: Investor Relations Contact: Sanjay M.
Hurry, 917-733-5573, sanjay.hurry@adnas.com LineaRx/LinearDNA
Platform Contact: Brian Viscount, 631-240-8877,
brian.viscount@adnas.com Web: www.adnas.com Twitter:
@APDN
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