Applied DNA Sciences Reports 14 Development Customers for its Linear DNA Manufacturing Platform
November 25 2019 - 9:15AM
Business Wire
Demonstrates Growing Interest and Demand for
Alternatives to Plasmids as Source of DNA in Pre-Clinical
Therapeutic Applications
Applied DNA Sciences, Inc. (NASDAQ: APDN, Applied DNA, “the
Company”) announced today that LineaRx, Inc., its majority-owned
subsidiary focused on next-generation biotherapeutics and
diagnostics, has grown its customer base to fourteen companies
currently testing its linear DNA manufacturing platform for the
development of nucleic acid-based therapies and diagnostics. The
Company believes this expansion is indicative of an increasing need
for an alternative to plasmids as the source of DNA.
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Applied DNA’s therapeutic and diagnostic client/partner base has
grown to fourteen companies developing a variety of therapeutic
indications including gene therapies, DNA vaccines against
infectious agents and cancer, and CAR T therapies with a variety of
transfection and transduction technologies, as well as several
others using our platform as a template for RNA production and in
vitro diagnostics “Not only is the breadth of application
expanding, but our clients represent market leaders in their
respective industries. Initial evaluations of our linear DNA have
yielded encouraging results, and optimization is under way,” said
Dr. James Hayward, CEO of Applied DNA.
“Our expansion in the commercial utility of our recent acquired
(invasive Circulating Tumor Cells) iCTC-based platform for
diagnostics in vitro has also attracted the attention of several
companies and research institutions, and we believe these emerging
opportunities will aid our growth next year,” added Dr.
Hayward.
In fiscal 2020, the Company anticipates continued growth of its
LineaRx client-base, while existing clients evaluate performance
both in vitro and in vivo through animal studies. The Company is
implementing plans to increase its manufacturing capacity and to
validate manufacturing and testing procedures in compliance with
FDA guidelines. The Company will also begin testing patent-pending
technologies that are available for licensing that we believe may
deliver higher levels of gene expression and longer functional
lifetimes for the expressed proteins, as well as amplicons using
episomal replication (in the nucleus, but not integrated
permanently into the genome). LineaRx’s clients and partners are
continuing to evolve complementary technologies, to determine the
best delivery technology for linear DNA with the goal of improved
therapeutic and diagnostic performance.
About LineaRx
LineaRx is commercializing the biotherapeutic value of Applied
DNA’s deep expertise and experience in the design, manufacture and
chemical modification of DNA by large scale polymerase chain
reaction (“PCR”). Linear DNA is a form of DNA distinct from the
circular form of DNA most commonly produced in plasmids and grown
in bacteria. Plasmids are extrachromosomal DNA found in bacteria
and are associated with the genes for antibiotic resistance which
are often exchanged between bacteria and consequentially, are seen
by many to embody a serious threat to global health. In addition,
many nucleic acid-based therapies also rely on viral vectors for
efficient transfection and expression of plasmid DNA. These viral
vectors carry additional nontrivial risks and are extremely time
consuming and expensive to manufacture. Go to www.adnas.com for
more information on LineaRx and to learn more about how Applied DNA
makes life real and safe. LineaRx is a majority-owned Applied DNA
Sciences, Inc. (Nasdaq: APDN) company.
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping, and pre-clinical nucleic acid-based
therapeutic drug candidates.
Applied DNA makes life real and safe by providing innovative,
molecular-based technology solutions and services that can help
protect products, brands, entire supply chains, and intellectual
property of companies, governments and consumers from theft,
counterfeiting, fraud and diversion.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list.
Common stock listed on NASDAQ under the symbol APDN.
Forward-Looking Statements
The statements made by Applied DNA in this presentation 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 substantial
doubt relating to Applied DNA’s ability to continue as a going
concern, uncertainties relating to its ability to maintain its
NASDAQ listing after December 31, 2019 in light of delisting
notices received and its recent hearing, the possibility of failure
to make timely payment on its outstanding secured convertible notes
and resulting enforcement by noteholders of remedies on collateral
which includes substantially all of Applied DNA’s assets, its
history of net losses, limited financial resources, limited market
acceptance, its ability to penetrate key markets, the uncertainties
inherent in research and development, future clinical data and
analysis, including whether any of Applied DNA’s or its partners
product candidates will advance further in the preclinical research
or clinical trial process, including receiving clearance from the
U.S. Food and Drug Administration or equivalent foreign regulatory
agencies to conduct clinical trials and whether and when, if at
all, they will receive final approval from the U.S. FDA or
equivalent foreign regulatory agencies, 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
18, 2018, as amended, our subsequent quarterly reports on Form 10-Q
filed on February 7, 2019, May 9, 2019 and August 13, 2019, and
other reports we file 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/20191125005217/en/
Investor contact: Sanjay M. Hurry, LHA Investor Relations,
212-838-3777, shurry@lhai.com Program contact: Brian
Viscount, 631-240-8877, brian.viscount@adnas.com web:
www.adnas.com, www.linearxdna.com twitter: @APDN, @LineaRxDNA
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