UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): April 1, 2020

 

GUARDION HEALTH SCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-38861   44-4428421

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

15150 Avenue of Science, Suite 200

San Diego, CA 92128

(Address of principal executive offices, including zip code)

 

Registrant’s telephone number, including area code: (858) 605-9055

 

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))

 

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, par value $0.001 per share   GHSI   The NASDAQ Stock Market LLC

 

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 [X]

 

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. [  ]

 

 

 

 

 

 

Item 8.01 Other Events.

 

On April 1, 2020, Guardion Health Sciences, Inc. (the “Company”) issued a press release announcing that it received an initial purchase from Astramune Sdn Bhd for a sample order of its proprietary immuno-supportive formula. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

99.1 Press Release dated April 1, 2020

 

 

 

 

SIGNATURES

 

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.

 

  GUARDION HEALTH SCIENCES, INC.
Date: April 1, 2020    
  By: /s/ MICHAEL FAVISH
  Name: Michael Favish
  Title: Chief Executive Officer

 

 

 

 

 

Exhibit 99.1

 

 

 

Guardion Health Sciences Receives Initial Order from Malaysian Company for Exclusive Immuno-Supportive Formula

 

—Initial order for $875,000 from Astramune Sdn Bhd, a subsidiary of Ho Wah Genting Berhad

 

—Formula designed to provide immune-supportive benefits

 

—Formula developed by the Company’s NutriGuard business unit

 

San Diego, California - April 1, 2020 - Guardion Health Sciences, Inc. (“Guardion” or the “Company”) (Nasdaq: GHSI), a company (i) that has developed medical foods and medical devices in the ocular health marketplace and (ii) that is developing nutraceuticals that the Company believes will provide health benefits to consumers, announced today that it received an initial order from Astramune Sdn Bhd, a subsidiary of Ho Wah Genting Berhad (“HWGB”) (KLSE: 9601), a Malaysian company listed on the Malaysian Stock Exchange (Industrial Products sector), for a sample order of its proprietary immuno-supportive formula. Guardion currently anticipates shipping this sample order by June 30, 2020.

 

The Company had previously announced in February 2020 that HWGB contracted Guardion and its wholly-owned subsidiary, NutriGuard, to develop an immuno-supportive formula for the HWGB consumer base. Dr. Mark McCarty, the original founder of NutriGuard, and now a senior scientist/consultant to Guardion, has led the development of this proprietary formulation.

 

Michael Favish, CEO of Guardion Health Sciences, commented, “We were pleased to have been selected by HWGB to utilize our expertise and resources to develop a proprietary product that is specifically designed to boost immune system capability. Given the demand expected from HWGB’s customer base, we are advised that HWGB is ramping up this business line, and we are preparing to be able to meet HWGB’s product requirements during 2020 and thereafter.”

 

Dr. McCarty is a leader in the scientific validation of nutrition-based therapies for potentiating the type 1 interferon response to RNA viruses. The formula is designed to provide immuno-supportive benefits to its users. The formulation has not been used or tested for, nor is it intended to specifically address, symptoms of the coronavirus (COVID-19).

 

About NutriGuardTM

 

NutriGuardTM formulates high-quality nutraceuticals, which are designed to supplement consumers’ diets. NutriGuard uses industry standards to establish the safety and efficacy of the products it develops and markets, maintains that commitment through prudent manufacturing and quality assurance programs, and only uses manufacturers who comply with FDA current Good Manufacturing Practices (cGMP) requirements. Guardion plans to increase NutriGuard’s existing customer base and build on its product platform by making NutriGuard products available to patients directly and through recommendations by their physicians.

 

 

 

 

 

 

About Guardion Health Sciences, Inc.

 

Guardion is a specialty health sciences company (i) that has developed medical foods and medical devices in the ocular health marketplace and (ii) that is developing nutraceuticals that the Company believes will provide medicinal and health benefits to consumers. Information and risk factors with respect to Guardion and its business, including its ability to successfully develop and commercialize its proprietary products and technologies, may be obtained in the Company’s filings with the SEC at www.sec.gov.

 

Forward-Looking Statement Disclaimer

 

With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements involve unknown risks and uncertainties that may individually or materially impact the matters discussed herein for a variety of reasons that are outside the control of the Company, including, but not limited to, the Company’s ability to raise sufficient financing to implement its business plan, the impact of the coronavirus (COVID-19) on the Company’s business and the economy in general, and the Company’s ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward- looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s filings with the SEC, which are available at the SEC’s website (www.sec.gov). The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Guardion Health Sciences, Inc.

 

15150 Avenue of Science, Ste. 200

San Diego, CA 92128

Ph 858.605.9055; Fax 858.630.5543

www.guardionhealth.com

 

Investor Relations Contact:

 

Jenene Thomas

JTC Team, LLC

Telephone: (833) 475-8247
E-Mail: jtc@jtcir.com

 

Porter, LeVay & Rose, Inc.

 

Michael Porter

Telephone: (212) 564-4700
E-mail: mike@plrinvest.com