Applied DNA Announces Continued Momentum in COVID-19 Testing Demand

Rhea-AI Summary

Applied DNA Sciences, Inc. (NASDAQ: APDN) reports over a 90% increase in COVID-19 testing levels for the quarter ending December 31, 2021, compared to the prior quarter. This growth is attributed to new safeCircle™ clients and increased demand from existing clients for managed testing solutions. The company secured a subcontract for community-based pop-up testing services. CEO Dr. James A. Hayward states a focus on long-term market sectors and mentions plans to file for Emergency Use Authorization (EUA) for their Linea™ 2.0 COVID-19 Assay.

Positive

• COVID-19 testing levels increased over 90% for the quarter ending December 31, 2021.
• Demand for safeCircle™ testing services is strengthening with onboarding of new clients.
• Secured a subcontract for community-based COVID-19 testing, expanding service capabilities.

Negative

• None.

- FQ1’22 Testing Levels Up Over 90% Compared to FQ4’21, Reports Further Strengthening in FQ2’22 to Date -

- Increase In Testing Levels Reflects Diversity in Demand and the On-boarding of New safeCircle™ Clients; Secures Subcontractor Award for Community-based Pop-Up Testing Service -

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs (ADCL), has seen COVID-19 testing levels increase greater than 90% (unaudited) for the quarter ended December 31, 2021, compared to the fiscal quarter ended September 30, 2021. ADCL has also seen a further strengthening of demand since the quarter ended December 31, 2021, to date. ADCL attributes the increase in demand to current safeCircle™ clients seeking to safely reopen or increase activities at municipalities, campuses, and businesses and the on-boarding of new clients. ADCL’s safeCircle program is a fully integrated testing platform for enterprise and educational institutions that provides a full range of COVID-19 diagnostic testing and associated services, including sample collection, test site infrastructure design and management, results tracking, and vaccination status management.

safeCircle’s sales prospects have also increased in number as enterprises seek to put into place managed COVID-19 testing practices to mitigate impacts and other risks to business continuity and to prepare themselves for further development of the COVID-19 pandemic and its possible scenarios.

ADCL also announced that it secured a testing subcontract to service a municipal COVID-19 testing award. Under the testing subcontract, ADCL is testing COVID-19 samples provided by multiple community-based pop-up collection sites.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, “Our approach to COVID-19 testing remains strategic whereby we are focused on market segments in which we expect testing to be longer-lived. We have proved the safeCircle platform in our operating area and are moving to deploy it nationally with the imminent filing of a request for EUA to the FDA for our Linea™ 2.0 COVID-19 Assay and an associated unsupervised, at-home sample collection kit.”

About Applied DNA Sciences

Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

Leveraging its deep expertise in nucleic acid-based technologies, the Company has also established safeCircle™, a high-throughput turnkey solution for population-scale COVID-19 testing. safeCircle is designed to look for infection within defined populations or communities utilizing high throughput testing methodologies that increase testing efficiencies and provide for rapid turn-around-times.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

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 possibility that Applied DNA’s assay kits or testing services could become obsolete or have its utility diminished and the unknown amount of revenues and profits that will results from Applied DNA’s testing contracts. Further, the uncertainties inherent in research and development, future data and analysis, including whether any of Applied DNA’s or its partner’s future diagnostic candidates will advance further in the research 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, the unknown limited duration of any EUAs from the FDA, changes in guidance promulgated by the CDC, FDA, CMS an/or NYSDOH relating to COVID-19 testing, disruptions in the supply of raw materials and supplies, continued mutations of the SARS-CoV-2 virus, shifting review priorities of FDA for COVID-19 EUA requests and when, if at all, any EUA request will be reviewed by FDA, 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, 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/20220118005756/en/

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

safeCircle Program Manager: Mike Munzer, 631-240-8814, mike.munzer@adnas.com

Web: www.adnas.com

Twitter: @APDN

Source: Applied DNA Sciences, Inc.

FAQ

What recent testing levels did Applied DNA Sciences report for APDN?

Applied DNA Sciences reported over a 90% increase in COVID-19 testing levels for the quarter ending December 31, 2021.

What factors contributed to the increase in testing levels for APDN?

The increase is attributed to new safeCircle™ clients and heightened demand for managed testing solutions.

Did Applied DNA Sciences secure any new contracts recently?

Yes, Applied DNA secured a subcontract for community-based pop-up COVID-19 testing services.

What are the future plans for Applied DNA Sciences related to COVID-19 testing?

The company plans to file for Emergency Use Authorization (EUA) for its Linea™ 2.0 COVID-19 Assay.