UNITED STATES

 

SECURITIES AND EXCHANGE COMMISSION

 

Washington, DC 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 27, 2020

 

Hepion Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware 001-36856 46-2783806
(State or other jurisdiction (Commission IRS Employer
of incorporation or organization) File Number) Identification No.)

 

  399 Thornall Street, First Floor  
  Edison, NJ 08837  
  (Address of principal executive offices)  

 

Registrant’s telephone number, including area code: (732) 902-4000

 

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

 

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   HEPA   Nasdaq Capital Market

 

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 communication 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 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.  x

 

 

 

 

 

 

Item 8.01 Other Events

 

On August 27, 2020, Hepion Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it will present a poster on CRV431's antifibrotic activity at the Digital International Liver Congress™ 2020 (EASL), taking place from August 27-29, 2020. 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 Hepion Pharmaceuticals, Inc. Press Release dated August 27, 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.

 

Dated: August 27, 2020

 

  HEPION PHARMACEUTICALS, INC.
   
  By: /s/ Robert Foster
    Robert Foster
    Chief Executive Officer

 

   1  

 

 

 

Exhibit 99.1

 

Hepion Pharmaceuticals to Present CRV431 Preclinical Data at the 2020 Digital International Liver Congress™

 

EDISON, N.J., August 27, 2020 - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA, “Hepion”), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”), today announced that it will present a poster on CRV431’s antifibrotic activity at the Digital International Liver Congress™ 2020 (EASL), taking place from August 27-29, 2020.

 

Dr. Joseph Kuo will present a preclinical study evaluating CRV431's ability to reduce hepatic fibrosis and fatty diet-induced body weight gain in a mouse model of NASH.

 

Presentation Details

 

CRV431 decreases diet- and chemical-driven fibrosis in livers of mice 

Poster presentation number: FRI-239 

Authors: Joseph Kuo1, Erika Cabrera1, Patrick Mayo2, Daren Ure2, Robert Foster2, and Philippe Gallay1 

1Department of Immunology & Microbiology, The Scripps Research Institute, La Jolla, California, USA. 2Hepion Pharmaceuticals, Edison, New Jersey, USA. 

Date: Friday, August 28, 2020

 

About Hepion Pharmaceuticals

 

Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and other types of hepatitis. The Company’s lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431’s potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease.

 

Forward Looking Statements

 

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.

 

For further information, please contact:

 

Stephen Kilmer

Hepion Pharmaceuticals Investor Relations

Direct: (646) 274-3580

skilmer@hepionpharma.com

 

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