8-K

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): May 5, 2020

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 Capital Market

Item 7.01 Regulation FD Disclosure.

On May 5, 2020, Dr. James A. Hayward, Ph.D., Sc.D., President and CEO of Applied DNA Sciences, Inc. is presenting at the Maxim Infectious Disease Virtual Conference. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Forward-Looking Statements

To the extent that statements contained herein or in the presentation attached hereto as Exhibit 99.1 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 there being no assurance that our vaccine (or diagnostic) candidate will be successfully shown to provide immunity (or detect) SARS-CoV-2, that the vaccine (or diagnostic) candidate will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that the vaccine candidate can be manufactured in large quantities or that third parties with an established presence in vaccine distribution, compliance and marketing will enter into an agreement with the Company or Takis, that positive results in animals may not be predictive of human outcomes after DNA vaccination, that numerous other SARS-CoV-2 vaccines (and diagnostics) are under development by other third parties, any of which may be more successful than the Company’s and Takis’ vaccine candidate (or the Company’ diagnostic candidate) and even if the Company’s and Takis’ vaccine candidate (or the Company’ diagnostic candidate)  is successful, it may generate only limited revenue and profits for the Company, the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, 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 partners therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, 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 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, 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.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.	Description
99.1	Presentation by James A. Hayward, Ph.D, Sc.D., President and CEO at the Maxim Infectious Disease Virtual Conference, dated May 5, 2020

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: May 5, 2020	APPLIED DNA SCIENCES, INC.
	By:	/s/ James A. Hayward
	Name:	James A. Hayward
	Title:	Chief Executive Officer

EXHIBIT INDEX

Exhibit No.	Description
99.1	Presentation by James A. Hayward, Ph.D, Sc.D., President and CEO at the Maxim Infectious Disease Virtual Conference, dated May 5, 2020

EX-99.1

Exhibit 99.1

Infectious Disease Virtual Conference - May 2020 Jim Hayward, Ph.D., Sc.D. – President & CEO james.hayward@adnas.com Using Spike to Vanquish Covid - 19

FORWARD LOOKING STATEMENTS The statements made by Applied DNA Sciences, Inc . (“the Company”, or “us”) herein regarding the Company and its business may be “forward - looking” in nature within the meaning of Section 27 A of the Securities Act of 1933 , Section 21 E 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 there being no assurance that our vaccine (or diagnostic) candidate will be successfully shown to provide immunity (or detect) SARS - CoV - 2 , that the vaccine (or diagnostic) candidate will be approved for use by the U . S . FDA or any equivalent foreign regulatory agency, that the vaccine candidate can be manufactured in large quantities or that third parties with an established presence in vaccine distribution, compliance and marketing will enter into an agreement with the Company or Takis, that positive results in animals may not be predictive of human outcomes after DNA vaccination, that numerous other SARS - CoV - 2 vaccines (and diagnostics) are under development by other third parties, any of which may be more successful than the Company’s and Takis’ vaccine candidate (or the Company’ diagnostic candidate) and even if the Company’s and Takis’ vaccine candidate (or the Company’ diagnostic candidate) is successful, it may generate only limited revenue and profits for the Company, the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, 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 partners therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U . S . Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U . S . FDA or equivalent foreign regulatory agencies, 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 12 , 2019 and our subsequent quarterly report on Form 10 - Q filed on February 6 , 2020 , 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 .

Spike Protein Vaccines • Human trials scheduled to begin in October. • 5 LinearDNA ™ Constructs of S gene in test, plasmid - free. • All strongly immunogenic in animals. • Epitope - mapped, codon - optimized, episomal, non - integrating • In preclinical testing. Italian MoH authorized; 1 st in Europe with Takis Biotech. • 1 injection yields neutralizing Ab’s in mice. Data of Spallanzani Institute, Rome. Tested on functional SARS - CoV - 2 virus in human cell culture. 1 st in category. • Low human dose could empower large - scale production. Diagnostics • rRT - PCR, multiplexed twin S gene targets; enhanced sensitivity • LLOD 1.25 copies of genome • Fewer false negatives • Detects 74 stable variants • Designed for high - throughput workflows. • Same day results to physician; 100% specificity. • EUA applied. Validation at Stony Brook University Hospital. Amendment planned to extend equipment platforms and patient sample techniques • Saliva without RNA extraction – improved workflow; patent pending, evaluation looks promising.by requiring less DNA per vaccination.Candidates