STONY BROOK, NY / ACCESSWIRE / August 29, 2023 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced the general availability of Linea™ IVT platform evaluation kits (the "Kit") and the first shipment of a Kit to an existing Linea™ IVT Template customer. The newly launched Kit, comprised of Linea™ IVT template, a buffer system, and Linea™ RNA Polymerase (RNAP), supports the conversion of current template evaluation customers to Linea IVT.
"The economics of Linea IVT are extremely compelling to us and are on the order of a 3-fold increase in contract value1 compared to equivalent standalone orders of Linea IVT templates," stated Dr. James A. Hayward, president and CEO of Applied DNA. "As such, we are centrally focused on expanding our base of evaluation customers ahead of bringing online our cGMP-quality production capacity in early calendar year 2024 that we believe will lay the foundation for the platform's commercial-scale contract awards."
"Our recent receipt of commercial scale amounts of Linea RNAP and the availability of the Kit less than 7 weeks after the acquisition of Spindle highlights our ability to execute and our commitment to the Linea IVT platform," concluded Dr. Hayward. "With large quantities of the RNAP in hand, we can now offer enough Kits to enable the manufacture of mRNA equivalent to approximately 233,000 COVID-19 30 μg vaccine doses1, which we believe is sufficient to service our current pipeline of evaluation customers."
1Based on the Company's internal modeling and estimates.
Linea™ IVT Platform
The Linea IVT platform combines cell-free, enzymatically produced Linea™ DNA IVT templates with its proprietary Linea RNAP 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.
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.
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.
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, 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, [email protected]
Program contact: Brian Viscount, 631-240-8877, [email protected]
SOURCE: Applied DNA Sciences, Inc.