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): November 7, 2019

 

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:

 

o  Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

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

 

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

 

o  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 November 7, 2019, Hepion Pharmaceuticals, Inc. issued a press release announcing  that it will present at The Liver MeetingÒ 2019, hosted by the American Association for the Study of Liver Diseases (AASLD), to be held in Boston, MA from November 8-12, 2019.    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 November 7, 2019

 

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: November 7, 2019

 

 

 

HEPION PHARMACEUTICALS, INC.

 

 

 

 

 

 

 

By:

/s/ Robert Foster

 

 

Robert Foster

 

 

Chief Executive Officer

 

2


Exhibit 99.1

 

Hepion Pharmaceuticals to Present at The Liver MeetingÒ 2019

 

EDISON, N.J., November 7, 2019 - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), 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 at The Liver MeetingÒ 2019, hosted by the American Association for the Study of Liver Diseases (AASLD), to be held in Boston, MA from November 8-12, 2019.

 

The poster presentation will address CRV431’s ability to decrease liver fibrosis in a carbon tetrachloride mouse model of liver injury and compare its activity to obeticholic acid, a leading, late clinical-phase drug candidate for NASH. CRV431 was found to concentrate in the liver, the intended site of action, which helps to explain its efficacious activity.

 

Dr. Daren Ure, Chief Scientific Officer of Hepion Pharmaceuticals, who will be presenting the poster, said, “Having previously demonstrated CRV431’s ability to reduce liver fibrosis in several studies in experimental NASH, the present findings from a very different experimental model provide strong, additional evidence that direct targeting of fibrotic disease processes in the liver is one of CRV431’s primary mechanisms of action.”

 

Presentation Details

 

CRV431 Targets the Liver and Decreases Liver Fibrosis in the Carbon Tetrachloride Mouse Model

Publication Number:  2242

Authors:  Daren Ure(1), Joseph Kuo(2), Michael Bobardt(2), Udayan Chatterji(2), Daniel Trepanier(1), Philippe Gallay(2), Robert Foster(1)

 


(1)Hepion Pharmaceuticals, Inc. (2)Department of Immunology & Microbiology, The Scripps Research Institute

 

Date:  Monday, November 11, 2019

Time:  12:30 – 1:30 pm

Location:  Hynes Convention Center, Hall B

 

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; 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, 2018 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