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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

 

 

Date of Report (Date of earliest event reported): August 2, 2022

 

Applied DNA Sciences, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction

of incorporation)

001-36745

(Commission File Number)

59-2262718

(IRS Employer

Identification No.)

 

50 Health Sciences Drive

Stony Brook, New York 11790

(Address of principal executive offices; zip code)

 

Registrant’s telephone number, including area code:  

631-240-8800

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, $0.001 par value   APDN   The Nasdaq Stock Market

  

 

 

 

 

 

 

Item 8.01 Other Events.

 

On August 2, 2022, Applied DNA Sciences, Inc. (the “Company”), issued a press release announcing its initiation of analytical validation of a Company-developed, PCR-based monkeypox virus test. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

  

Item 9.01.   Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1 Press Release dated August 2, 2022.
104 Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: August 2, 2022 APPLIED DNA SCIENCES, INC.
     
  By: /s/ James A. Hayward
  Name:   James A. Hayward

 

 

 

 

 

 

Exhibit 99.1 

 

 

 

Applied DNA Initiates Analytical Validation of PCR-based
Diagnostic Test Specific to Monkeypox Virus

 

STONY BROOK, N.Y. – August 2, 2022 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in polymerase chain reaction (“PCR”)-based technologies, announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (“ADCL”), has initiated analytical validation of a Company-developed, PCR-based monkeypox virus test that is specific for the genetic signature of the monkeypox virus. The test has been developed as a type of NYSDOH Laboratory Developed Test (“LDT”). If the test is validated by ADCL, a validation package will be submitted to New York State Department of Health (“NYSDOH”) for approval. If approved, the test will be used to power ADCL’s monkeypox testing services.

 

ADCL’s monkeypox test utilizes an A17L gene-target specific to monkeypox that enables the qualitative detection and differentiation of monkeypox virus from other non-variola orthopoxviruses using real-time PCR. If validated and approved, testing will be performed at ADCL’s CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y., utilizing its established and proven workflows to ensure accurate results and competitive turn-around-times.

 

“Based on our experience with the COVID-19 pandemic, we are keenly aware of the crucial role PCR-based diagnostic tools can play in responding and helping to control public health outbreaks. With a proven workflow and testing services born of COVID-19, upon test approval, ADCL stands ready to apply its testing capacity in service of New Yorkers’ health,” stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences.

 

To learn more about safeCircle™, ADCL’s testing platform: 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.

 

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 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 possibility that Applied DNA’s testing services could become obsolete or have their utility diminished and the unknown amount of revenues and profits that will results from Applied DNA's testing services. Further, the uncertainties inherent in research and development, future data and analysis, including whether any of Applied DNA'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 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, 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 and May 12, 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.

 

Contacts:

 

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

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

Web: www.adnas.com

Twitter: @APDN

 

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