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

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 production,
• 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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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 www.sec.gov. 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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