Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in PCR-based DNA technologies, today announced that it has established a new high bar for the production of DNA with the manufacture and shipment of a multi-gram quantity of linearDNA™ in under six weeks. The quantity was produced by the Company’s LinearDNA™ platform under a large recurring purchase order with a global manufacturer of in vitro diagnostics that was announced in the first quarter of fiscal 2023 and is the largest single shipment of linearDNA to date. The Company expects to ship a final multi-gram quantity in the third fiscal quarter of 2023 to fulfill the purchase order earlier than contractually stipulated.
“We believe that this production milestone underscores our LinearDNA platform’s capacity for the rapid, enzymatic production of DNA at very large scale that stands in stark contrast to the scalability bottlenecks and challenges associated with conventional plasmid DNA to support both high value biotherapeutic and lower price-point diagnostic applications,” stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences. “Building on our platform’s inherent advantages of speed and scale, we are concurrently pursuing platform optimizations and a timeline to cGMP (current Good Manufacturing Practices) that we believe will enhance linearDNA’s standing as an alternative source of DNA. The future of our LinearDNA platform will have it supplying the needs of the entire DNA demand curve, from GLP-grade (Good Laboratory Practices) product for in vitro diagnostics and biotherapeutic research and development to cGMP-grade, therapeutic DNA as a direct replacement for plasmid DNA-reliant nucleic acid-based therapies.”
The Company’s LinearDNA platform is focused on empowering the next generation of nucleic acid-based therapies. The platform uses a cell-free, enzymatic approach that confers the advantages of simplicity, purity, speed, flexibility, and scalability in a fractional footprint relative to conventional plasmid DNA (fermentation)-based manufacturing processes. The resultant DNA, known as linearDNA™, is currently produced at GLP-grade in volumes from micrograms to grams to support customers’ needs. The Company is pursuing a timeline for cGMP linearDNA production that will enable it to support customers from research and development and drug discovery through large-scale manufacturing for clinical trials and commercial use. Learn more about linearDNA at www.linearrxdna.com
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid (“DNA”). Using PCR to enable both the production and detection of DNA, we operate in three primary business markets: (i) the manufacture of DNA for use in nucleic acid-based therapeutics; (ii) the detection of DNA in molecular diagnostics testing services; 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 any customer order for linearDNA or any linearDNA-based therapeutic, whether any of Applied DNA’s or its customers therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval as therapeutic products from the FDA, the USDA 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, 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 Form 10-Q filed on February 9, 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.
"The future of our LinearDNA platform will have it supplying the needs of the entire DNA demand curve, from GLP-grade (Good Laboratory Practices) product for in vitro diagnostics and biotherapeutic research and development to cGMP-grade, therapeutic DNA."