Applied DNA Announces Notice of Allowance for U.S. Patent Covering Fundamental Aspect of its Linea(TM) IVT Platform

Patent covers the Composition of the Company’s Proprietary Linea™ RNAP, a Core Technology Empowering the Linea™ IVT Platform

Patent Application Also Currently Pending in Key International Markets

STONY BROOK, NY / ACCESSWIRE / June 5, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA or the “Company”), a leader in PCR-based DNA technologies, announced today that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 18/302,247, entitled “Compositions and Methods for RNA Synthesis.”

The resulting patent will cover the composition of the Company’s chemically modified RNA polymerase enzyme branded Linea™ RNAP, with expected patent protection into 2041. Linea RNAP is a core component of the Company’s Linea™ IVT platform that empowers mRNA manufacturers to produce better mRNA faster via a simplified mRNA production workflow with reduced or eliminated double-stranded RNA (dsRNA) contamination. Applied DNA acquired the technology underlying the Linea RNAP via its acquisition of Spindle Bio, Inc. in July 2023.

“This patent allowance, coupled with the upcoming initiation of our GMP capabilities, demonstrates our commitment to supplying GMP-grade critical starting materials for the manufacture of mRNA,” said Dr. James A. Hayward, president and CEO of Applied DNA. “With approximately 450 mRNA therapies under development globally, and with a large majority of these therapies in the preclinical stage, we believe we can build significant market share via our differentiated Linea IVT platform and its numerous advantages over conventional mRNA production workflows.”

About the Linea™ DNA and Linea™ IVT Platforms

The Linea DNA platform is an entirely cell-free DNA production platform founded on Applied DNA’s long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.

The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea™ RNAP to enable mRNA and sa-mRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of double-stranded DNA (dsRNA) contamination; and 3) simplified mRNA production workflows.

About Applied DNA Sciences

Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid (“DNA”). Using the polymerase chain reaction (“PCR”) to enable both the production and detection of DNA, we operate in three primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and, through our recent acquisition of Spindle Biotech, Inc. (“Spindle”), the development and sale of a proprietary RNA polymerase (“RNAP”) for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.

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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 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, the availability of sufficient financial and other resources to meet business objectives and operational requirements the unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from its Linea IVT and or Linea DNA platforms, the development and utilization of, and challenges to, our intellectual property, 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, as amended, filed on December 7, 2023 and Quarterly Report on Form 10-Q filed on February 8, 2024, and May 10, 2024, 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.

Contacts:

Applied DNA Sciences

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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