Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced the completion of the buildout of its new Good Manufacturing Practices (GMP) manufacturing facility (the "facility") within its Stony Brook, New York, headquarters and readiness to accept orders for the manufacture of LineaDNA™ IVT templates that clients can utilize for the production of mRNA clinical trial materials. The facility is undergoing final testing and is expected to be fully operational by the end of the current month. The Company also announced that it is actively negotiating a supply agreement for GMP IVT template with a mRNA therapeutic developer.
Separately, the Company reaffirmed its intention to complete the implementation of its previously announced strategic restructuring plan by the end of the current quarter. The restructuring is intended to drive sustainable growth from LineaRx, Inc., its biotherapeutic subsidiary, optimize Applied DNA's cost structure, and extend the parent company's cash runway.
GMP Facility Overview:
Based on updated modeling, an initial projected annual IVT template manufacturing capacity of approximately ten (10) grams with 100% cell-free workflow;
10mg to gram-scale production in 6-14 weeks with multiple purification options;
Dedicated warehouse, process development, analytical testing, and quality control areas;
The capacity to deliver chemically modified LineaDNA IVT templates paired with the Company's proprietary RNA polymerase to mitigate double-stranded DNA (dsRNA) contaminants in commercial-scale mRNA production; and,
A projected revenue capacity ranging from $10 million to $30 million, depending on product mix (sales of IVT template or the paired-IVT template and Linea™ RNA polymerase for mRNA production[1].)
"Once operational, our GMP facility stands ready to support the development of next-generation genetic medicines with a cell-free, enzymatic approach to IVT template production that confers the advantages of simplicity, purity, speed, flexibility, and scalability in a fractional footprint relative to conventional plasmid-DNA (fermentation)-based IVT template manufacturing processes. We believe we are in an unmatched position to help bring the advantages of synthetic DNA to our clients to develop innovative therapies," stated Dr. James A. Hayward, chairman and CEO of Applied DNA.
Added Clay Shorrock, president of LineaRx, Inc., "We believe the upcoming operational launch of our GMP facility is a pivotal junction for the Company, representing the final piece of a multi-year business strategy to commercialize our LineaDNA and Linea IVT platforms and return us to a growth trajectory. With a strong GMP sales funnel for IVT templates and in active negotiations on our first supply agreement, we look forward to engaging with our therapeutic developer and CDMO customers to support their cell-free DNA needs."
[1] Based on internal Company data and modeling.
About the LineaDNA™ and Linea™ IVT Platforms
The LineaDNA 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 LineaDNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the LineaDNA 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 LineaDNA 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 currently operate in three primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and 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.
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 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 fact that there has never been clinical trial material and/or commercial drug product produced utilizing the LineaDNA and/or Linea IVT platforms, 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 on December 17, 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.
