Market Overview

Applied DNA Sciences Reaches New Milestones in Therapeutic Contract Research and Contract Manufacturing of Linear DNA


Diagnostics Shipments, Vaccines Research, CAR T, and System
Development bring in Requests for DNA

DNA Sciences
Inc., ("the Company") (NASDAQ:APDN), among the world's
largest producers of linear DNA, has reached new technical milestones in
the growth of its Contract Research (CRO) and Contract Manufacturing
(CMO) businesses. In the past 12 months, Applied DNA has shipped over
8,000 milligrams of PCR-produced linear DNA for use in Diagnostic and
Therapeutic applications. The Company has completed, or is progressing
through, key milestones of a growing number of therapeutics research
contracts for companies producing DNA and RNA vaccines and adoptive cell
therapies. Key milestones of success for these gene therapies are
delivery of DNA effectively into a cell, expressing the gene product
from that DNA and eventually demonstrating the desired clinical outcome.

These projects are following the typical preclinical biotherapeutic path
of proving efficacy at small scale prior to securing larger production
appropriate for clinical trials and deployment.

Most DNA-based therapeutic products, both approved and in development,
rely on legacy science of plasmid and viral vector production methods
that are time-consuming, carry the risks of bacterial toxins and
triggering complications or unintended consequences. Several recent
clinical trials have been halted by FDA due to unintended consequences
of plasmid-derived DNA. As an alternative, Polymerase Chain Reaction
(PCR), is a well-proven technique of DNA amplification first introduced
in the 1980's as an investigative tool in research and diagnostic
laboratories. Applied DNA's patented large-scale PCR production
capability is a breakthrough for therapeutic applications as it has
already demonstrated that PCR product can be made available very cleanly
and at the scale required for population-scale diagnostics.

The most significant Applied DNA milestones recently achieved in this
field come from work with multiple companies worldwide to qualify
PCR-based linear DNA expression constructs for therapeutic applications.
From these collaborative efforts, we have shown that linear DNA is
effective in expression of genes in vivo.

These forms are in direct contradistinction to Applied DNA's DNA tags
for supply chains, which are too small to express proteins, have no
means of entering cells or tissues, and contain none of the control
elements necessary to do so.

This accomplishment is among the first times a linear DNA expression
amplicon produced by PCR has demonstrated expression in vivo.

In all cases, companies in our pipeline have been driven to Applied
DNA's market position as an alternative to the current science of
plasmid-produced DNA to gain PCR-based linear DNA vectors inherently
superior to plasmid and viral vectors in several important aspects:

  • Bacteria-free: Absence of bacterial plasmid contaminants or sequences
    of prokaryotic origin such as genes for antibiotic resistance,
  • Speed: Shorter lead times (days) from vector design to large scale
  • Custom design turnaround time: custom modifications in sequence during
    the PCR process to enable experimentation comparisons on therapeutic
    performance, and,
  • On-site Production: patented platform for large scale production
    supports the feasibility of DNA production closer and tailored to the
    point of care to support the concept of personalized medicine.

"The milestones achieved to-date are a result of a multi-year business
plan beginning with the acquisition of Vandalia Research assets three
years ago. Now attracting new business at an accelerating rate and
showing results that go toe-to-toe with legacy plasmid production is a
major milestone for the viability of PCR-produced DNA for use in
therapeutics," said Dr. James Hayward, president and CEO of Applied DNA.
"We will continue to work with companies developing therapeutics to
expand the processes necessary to grow this business alongside our
mainstay tagging business."

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 DNA mass production for diagnostics and therapeutics.

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. The proprietary DNA-molecular based "CertainT®"
platform can be used to identify, tag, test, and track products, to help
assure authenticity, origin, traceability, sustainability and quality of
products. SigNature® DNA describes the core technology
ingredient that is at the heart of a family of uncopyable, security and
authentication solutions such as SigNature® T and fiberTyping®,
targeted toward textiles and apparel, BackTrac™ and DNAnet®,
for anti-theft and loss prevention, and digitalDNA®,
providing powerful track-and-trace. All provide a forensic chain of
evidence and can be used to prosecute perpetrators. Applied DNA Sciences
is also engaged in the large-scale production of specific DNA sequences
using the polymerase chain reaction.

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Common stock listed on NASDAQ under the symbol APDN, and warrants are
listed under the symbol APDNW.

Forward Looking Statements

The statements made by Applied DNA in this press release may be
"forward-looking" in nature within the meaning of the Private Securities
Litigation 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 our history of
losses, limited financial resources, limited market acceptance, 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 28, 2017and our subsequent quarterly reports on Form 10-Q filed
on February 8, 2018 and May 3, 2018, which are available at
APDN undertakes no obligation to update publicly
any forward-looking statements to reflect new information, events or
circumstances after the date hereof to reflect the occurrence of
unanticipated events, unless otherwise required by law.

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