Applied DNA to Establish North America’s First Enzymatic (Cell Free) Large-Scale cGMP DNA Manufacturing Capacity in Suffolk County, New York

By: Applied DNA Sciences, Inc. via Business Wire

October 24, 2022 at 09:30 AM EDT

- Planned Doubling of Current DNA Production Capacity will Enable Company to Support Customers from Early-stage Drug Discovery Through Late-phase Clinical Trials -

- Expansion Plans Catalyzed by Growing Industry Demand for LinearDNA™, Repeat and New Proof-of-Concept Orders from Customers with Long-Term Requirements for cGMP DNA –

- Operational Commencement Expected in 2H CY2023 -

Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in PCR-based DNA technologies, announced today plans to establish a new, separate manufacturing facility to be located in Suffolk County, New York, for the enzymatic production of cGMP LinearDNA™ for use in genetic medicines. The expansion plan will double the Company's production capacity and is being undertaken in response to the growing number of new nucleic acid-based therapies under development¹ and in the market that are driving greater demand for high-quality, large-scale therapeutic DNA, as well as a healthy backlog of repeat and new proof-of-concept orders, the latter from leading pharma/biotech customers that have expressed a long-term need for cGMP DNA at scale. Concurrently, the Company is in active discussions with New York State, local municipalities, and private entities regarding funding opportunities that may assist in underwriting the costs of its planned cGMP build-out.

Steve Bellone, the Suffolk County Executive, stated, “Long Island’s DNA Corridor is the beating heart of the region’s premier life sciences hub. The advances in medicine being used today to combat the pandemic that now serve as the basis for mRNA vaccines were birthed here. The area continues to advance the forefront of modern medicine with local talent like Applied DNA, whose enzymatically produced DNA holds the potential to transform human health. I am pleased to lend my Office’s support to help it reach its goals for the benefit of us all.”

LinearDNA is produced using the Company’s proprietary LinearDNA platform, a novel, enzymatic DNA manufacturing approach capable of rapidly producing high-quality DNA for nucleic acid-based therapies, including mRNA therapies, cell and gene therapies, and DNA vaccines. Unlike large and capital-intensive plasmid-based DNA production facilities, the LinearDNA platform uses bench-top equipment to rapidly produce DNA in a minimal physical footprint. The Company’s majority-owned biotherapeutics subsidiary, LineaRx, Inc., currently serves pharma and biotech companies as a Contract Research Organization (CRO) with GLP-grade (Good Laboratory Practices) LinearDNA primarily for research and development applications.

Upon the planned commencement of operations in the second half of calendar 2023, the Company’s DNA production capacity will be approximately 50g/month, a 100% increase over its current monthly production capacity. The increased capacity will enable the Company to support customers from early-stage drug discovery through late-phase clinical trials, subject to necessary regulatory approvals. The planned cGMP capacity will utilize modular construction that can be implemented in multiple phases and can be quickly expanded if warranted by customer demand.

Dr. James A. Hayward, president and CEO of Applied DNA Sciences and LineaRx, said, “Having cultivated a marquee customer base in recent years, the gating factor to LinearDNA’s wider adoption has been our ability to support customers with cGMP-grade product for clinical trials and commercialization. With today’s announcement, we embark on a measured and risk-mitigated approach to LinearDNA scaleup and cGMP aligned with our recent capital raise and industry trends that are recognizing the value of enzymatic DNA manufacturing. As demand for enzymatically produced therapeutic DNA matures, we aim for our growth to be in lockstep with the industry’s needs.”

About LineaRx, Inc.

LineaRx, an Applied DNA Sciences, Inc. (NASDAQ: APDN) company, was formed in 2018 to commercialize the parent company's 20+ years of experience in polymerase chain reaction ('PCR')-based DNA manufacturing and leadership in enzymatic DNA production. LineaRx is developing and commercializing the LinearDNA™ platform as a cell-free enzymatic platform for the largescale DNA manufacture of high-fidelity DNA sequences for use in nucleic acid-based therapeutics. DNA manufactured via the platform is free of adventitious DNA sequences and can be chemically modified to optimize DNA for specific applications, offering compelling advantages over plasmid DNA in many biotherapeutic applications, from mRNA and DNA vaccines to redirected cell and gene therapies. To learn more about LinearDNA™: click here

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.

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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, 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 therapeutic candidates or manufacturing platforms will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (FDA), United State Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final or conditional approval from the FDA, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to FDA, USDA or equivalent foreign regulatory agencies, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, the unknown ability to manufacture therapeutic grade cGMP DNA in large quantities, 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 for local, municipal or state funding, 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 9, 2021, its Quarterly Report on Form 10-Q filed on February 10, 2022, May 12, 2022 and August 11, 2022 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.

¹ ASGCT Q2 2022 Gene, Cell and RNA Therapies Report. https://asgct.org/global/documents/asgct-pharma-intelligence-quarterly-report-draft-q.aspx

View source version on businesswire.com: https://www.businesswire.com/news/home/20221024005556/en/

Contacts

Corporate:

Investor Relations: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com

Program: Brian Viscount, 631-240-8877, brian.viscount@adnas.com

Web: www.adnas.com

Twitter: @APDN

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Applied DNA to Establish North America’s First Enzymatic (Cell Free) Large-Scale cGMP DNA Manufacturing Capacity in Suffolk County, New York

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