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  findings from a preclinical study where CRV431, a novel cyclophilin inhibitor, significantly decreased the extent of liver fibrosis in a highly regarded, Western Diet (“WD”) animal model of NASH.    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

 

2


 

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

 

3


 

Exhibit 99.1

 

Hepion Pharmaceuticals’ CRV431 Reduces Liver Fibrosis in a Western Diet Model of NASH

 

- CRV431 has Potently Reduced Fibrosis in all Experimental Models Tested To Date -

 

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 findings from a preclinical study where CRV431, a novel cyclophilin inhibitor, significantly decreased the extent of liver fibrosis in a highly regarded, Western Diet (“WD”) animal model of NASH.

 

Developed in the laboratory of Dr. Scott Friedman at Icahn School of Medicine at Mount Sinai, New York, this WD model employs a high-fat, high-fructose and high-cholesterol diet in combination with carbon tetrachloride (“CCl4”) to cause significant fibrosis and hepatocellular carcinoma in mice. The model replicates many of the metabolic and histologic features of human NASH. In this study, WD + CCl4-treated mice received either 50mg/kg/day of CRV431, 10mg/kg/day of Obeticholic acid (“OCA”), or vehicle control, orally. CRV431 reduced liver fibrosis by 82% (p<0.0001), whereas OCA reduced fibrosis by 49% (p=0.002), compared to mice that did not receive WD + CCl4. CRV431 also reduced the gain in weight caused by the Western Diet by 83% (p=0.01).

 

“CRV431 has potently and consistently reduced liver fibrosis in every experimental model in which CRV431 has been examined,” said Dr. Robert Foster, Chief Executive Officer of Hepion. “A total of seven studies spanning four experimental models and three independent testing sites have now shown CRV431 to decrease liver fibrosis arising from a variety of dietary, chemical, and biochemical insults. These findings include previously reported positive results in human liver samples as examined by precision cut liver slice methodologies, or PCLS.”

 

“Taken together, these studies suggest that CRV431 may be most effective in advanced stages of NASH where fibrotic activities are highly active. We are building one study upon another to drive our data portfolio, and the results continue to be outstanding. We plan to continue with many additional studies conducted in parallel with our clinical programs to develop a thorough understanding of this important mode of action in liver disease.”

 

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