STONY BROOK, N.Y.–(BUSINESS WIRE)–Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced that it received orders for its linear DNA to be evaluated in an RNA vaccine and Adeno-Associated Virus (AAV) production from two new contract research customers, respectively. The Company also received a follow-on order for linear DNA from an existing contract research customer for a preclinical CAR T therapy. The follow-on order marks the third order from the existing customer for use across multiple applications. All orders are to be shipped by the end of calendar 2020.
Applied DNA’s unique large-scale PCR production of linear DNA is made capable by its LinearDNA™ platform, a proprietary process that enables large, gram-scale production of single- or double-stranded DNA for diagnostics; therapeutics, such as CAR T; vaccines, such as those made of RNA and DNA; and improves the agility of virus production, such as AAV. Some COVID-19 vaccines utilize AAV as the vector for delivery of a synthetic gene that causes the transfected cell to release antigens that promote immunity to SARS-CoV-2. The Company announced in August 2020 that it filed a new U.S. patent application for the manufacture of AAV via its LinearDNA™ platform.
“Our LinearDNA manufacturing platform is paving a new path for nucleic acid-based drug development that, to date, is largely reliant on plasmid-based production that is lengthy, prone to toxin contamination, promulgating antibiotic resistance, accidental inclusion of non-target DNA, and genomic integration. To our knowledge, we are the only company to pursue the commercialization of linear DNA for diagnostic and therapeutic applications via large-scale PCR. We believe this makes us applicable to every preclinical or clinical nucleic acid-based drug production program being pursued by the industry’s leading companies. The addition of new development customers and repeat orders for linear DNA, we believe, suggests a growing appetite for a market-ready alternative to plasmids,” stated Dr. James A. Hayward, president and CEO, Applied DNA.
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 pre-clinical nucleic acid-based therapeutic drug candidates.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Applied DNA is a member of the Russell Microcap® Index.
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, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic or therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, the unknown outcome of any applications to U.S. FDA or equivalent foreign regulatory agencies, , 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 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020, May 14, 2020 and August 6, 2020, and other reports we file 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.