Applied DNA Announces Receipt of Largest Single Purchase Order for LinearDNA™ To-Date

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) has received its largest single purchase order for LinearDNA™, valued above mid-six figures, under a long-standing supply agreement with a global in vitro diagnostics manufacturer. The current quarter will see the delivery of LinearDNA, with fulfillment expected over the next three quarters. The enzymatic production platform enhances efficiency and safety, reducing contamination risks associated with traditional plasmid DNA. CEO Dr. James A. Hayward highlighted the potential of DNA-based probes in diagnostics and therapeutic applications.

Positive

• Received largest single purchase order for LinearDNA™ valued above mid-six figures.
• Contract under a long-standing supply agreement signifies customer trust.
• Enzymatic manufacturing process reduces contamination risks and enhances efficiency.
• LinearDNA positions the company in the growing fields of diagnostics and genetic medicine.

Negative

• Limited financial resources and history of net losses.
• Uncertainties in R&D and potential FDA regulatory hurdles.
• No commercial drug product utilizing PCR-produced DNA technology has been approved for therapeutic use.

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in PCR-based DNA technologies, announced today that it received its largest single purchase order for LinearDNA™ valued above the mid-six-figures. The order was placed under a long-standing supply agreement for the bulk manufacture of LinearDNA for a global manufacturer of in vitro diagnostics. Under the terms of the repeat order, the Company will deliver quantities of LinearDNA to the customer in the current quarter, with the full order expected to be fulfilled over the subsequent three quarters.

LinearDNA is produced using an enzymatic (cell-free) manufacturing platform that eliminates the use of fermenters and bacteria required by plasmid DNA, the industry’s current manufacturing standard for DNA. LinearDNA eliminates many of the challenges associated with current plasmid-based DNA manufacturing and produces a DNA product without the risks of bacterial contamination and non-target DNA sequences. The enzymatic process provides the means to optimize a customer-specific chemistry and sequence of LinearDNA. This capability has been leveraged for diagnostic applications, including today's announced repeat order, and is commonly used when customers order LinearDNA for use as IVT templates for RNA production.

Dr. James A. Hayward, president and CEO of Applied DNA, said, “The application of DNA-based probes in molecular diagnostics is rapidly expanding to give the industry powerful new tools to enhance the diagnosis of infectious diseases, genetic disorders, and malignancies. Our proprietary enzymatic approach to manufacturing DNA via PCR underpins our ability to produce DNA more efficiently and rapidly relative to other DNA production methods and at scale. Applying this capacity also to the manufacture of therapeutic DNA for the next generation of genetic medicines, we believe LinearDNA sits at the intersection of two growing life sciences segments that hold the potential to transform human health.”

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 and limited market acceptance. Further, the uncertainties inherent in research and development, future data and analysis, including whether any of Applied DNA or it customer’s current or future diagnostic candidates will advance further in the research and/or validation process or receiving authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health (NYSDOH), and whether and when, if at all, they will receive final authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or NYSDOH, the unknown outcome of any applications or requests to FDA, equivalent foreign regulatory agencies and/or the NYSDOH, disruptions in the supply of raw materials and supplies, 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 our Annual Report on Form 10-K filed on December 9, 2021, its Quarterly Report on Form 10-Qs filed on February 10, 2022, May 12, 2022, and August 11, 2022, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221010005187/en/

Corporate:

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

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

Web: www.adnas.com

Twitter: @APDN

Source: Applied DNA Sciences, Inc.

FAQ

What is the significance of the new purchase order for APDN?

APDN's new purchase order is significant as it represents their largest single order for LinearDNA™, reinforcing customer trust and potential revenue growth.

How does LinearDNA™ production differ from traditional methods used by APDN?

LinearDNA™ is produced using an enzymatic manufacturing platform, eliminating the risks of bacterial contamination associated with traditional plasmid DNA production.

What industries can benefit from LinearDNA produced by APDN?

LinearDNA is utilized in molecular diagnostics and has the potential for therapeutic applications, positioning APDN within two growing life sciences segments.

What challenges does APDN face in the market?

APDN faces challenges such as limited financial resources, a history of net losses, and uncertainties related to FDA approvals for their products.

What are the future prospects for APDN following this announcement?

Following this announcement, APDN may see increased market interest due to the expansion of their product applications in diagnostics and potential therapeutic markets.