Applied DNA Extends Application of Linea(TM) IVT Platform to saRNA (self-amplifying mRNA)

– Extension Increases Total Addressable Market to Include Both Conventional Non-Amplifying mRNA and saRNA –

– Extension Enabled by the Company’s Ongoing Platform Development and Optimization –

STONY BROOK, NY / ACCESSWIRE / November 16, 2023 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, announced the expansion of its Linea™ IVT platform (the “Platform”) to include the manufacture of self-amplifying mRNA (“saRNA”). Launched in July 2023, the Platform was previously optimized for smaller conventional non-amplifying mRNA constructs that currently comprise the bulk of demand for mRNA. saRNA is a promising new form of mRNA therapy engineered to possess a self-replicating capability. Unlike conventional non-amplifying mRNA, saRNA carries the machinery necessary for its replication, resulting in a higher therapeutic index at a lower dose.

The Platform combines the Company’s enzymatically produced Linea^TM DNA IVT templates and its proprietary Linea™ RNA polymerase (“RNAP”) to provide what the Company believes to be numerous advantages over conventional mRNA manufacturing methods, including (1) the prevention or reduction of double-stranded RNA (dsRNA) contamination resulting in higher target mRNA yields; (2) delivery of IVT templates in as little as 14 days for milligram scale and 30 days for gram scale; and (3) reduced manufacturing complexities.

The expansion of the Platform is the result of recent RNAP development projects that have enabled the optimization of the Linea RNAP to address the unique challenges presented by saRNA, which are often 3x-5x larger than conventional non-amplifying mRNA with higher sequence complexity. The Company announced on November 9 that it produced and shipped its first Linea DNA saRNA IVT templates to a customer.

“This expanded application of the Linea IVT platform allows us access to the saRNA manufacturing market with economics that affords us what we expect to be an approximately 3-fold increase in contract value as compared to equivalent standalone orders of Linea IVT templates[1],” stated Dr. James A Hayward, president and CEO of Applied DNA. “With our Platform’s ability to now address the two most common forms of mRNA therapeutics, we believe Linea IVT will prove an even more attractive method of enabling a broad range of RNA-based therapies. I applaud the Applied DNA team for their hard work to position us at the crossroads of the next generation of genetic medicine.”

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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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 DNA™ and/or Linea™ IVT platforms, limited market acceptance for its supply chain security products and services, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT or Linea DNA platforms 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: Brian Viscount, 631-240-8877, brian.viscount@adnas.com

Web: www.adnas.com

Twitter: @APDN

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