Applied DNA Files Provisional Patent Applications for Methods of Double-Stranded RNA Mitigation in Next-Generation mRNA Production

STONY BROOK, NY / ACCESSWIRE / August 23, 2023 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today announced the filing with the United States Patent and Trademark Office of two provisional patent applications claiming compositions of matter and methods to reduce or potentially eliminate double-stranded RNA (dsRNA) byproducts generated during the production of mRNA therapeutics. dsRNA is a widespread problematic impurity that can cause adverse reactions to mRNA therapies and is currently removed or mitigated using specialized purification instruments that reduce yields and increase manufacturing costs.

The recently filed provisional patents are foundational to Applied DNA’s recently launched Linea™ IVT platform that enables next-generation mRNA production by leveraging the unique attributes of the Company’s PCR-based LinearDNA^TM platform resulting in a simplified mRNA production workflow with reduced dsRNA contamination. The Linea IVT platform combines cell-free, enzymatically produced linearDNA IVT templates with the Company’s proprietary Linea™ RNA polymerase to deliver multiple advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of dsRNA contamination resulting in higher target mRNA yields; and, 3) the delivery of IVT templates in as little as 14 days for milligram scale and 30 days for gram scale.

“These provisional patent applications are the first step in protecting our valuable intellectual property that empowers our differentiated approach to mRNA production,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “Specifically, we believe the Linea IVT platform’s unique ability to mitigate problematic dsRNA while also providing for a simplified mRNA production workflow with potentially greater target mRNA yields is a compelling advantage over conventional mRNA production methods at a time when industry interest in mRNA therapeutics is accelerating.”

About Applied DNA Sciences

Applied DNA Sciences is a biotechnology company that utilizes polymerase chain reaction (“PCR”) to develop and commercialize platforms to produce and detect DNA and RNA. The Company operates in three primary business markets: (i) the manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and diagnostics, and the development and sale of a proprietary RNA polymerase for use in the production of mRNA therapeutics; (ii) the development of molecular diagnostics and genetic testing services based on the detection of DNA and RNA; and (iii) the manufacture and detection of DNA for industrial supply chain security services.

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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 the Linea™ IVT platform, the unknown patentability of the subject matter claimed in the provisional patent applications, limited market acceptance for its supply chain security products and services, the declining demand for Applied DNA’s COVID-19 testing services, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT platform 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 10-Q filed on February 9, 2023, May 11, 2023, and August 10, 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.

Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com

Program contact: Clay Shorrock, 631-912-6454, clay.shorrock@adnas.com

Web: www.adnas.com

Twitter: @APDN

SOURCE: Applied DNA Sciences, Inc.

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