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 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 August 7, 2019, Hepion Pharmaceuticals, Inc. issued a press release announcing that Dr. Stephen Harrison has joined its Scientific Advisory Board.   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 7, 2019

 

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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 7, 2019

 

 

 

HEPION PHARMACEUTICALS, INC.

 

 

 

 

 

 

By:

/s/ Robert Foster

 

Robert Foster

 

Chief Executive Officer

 

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Exhibit 99.1

 

Hepion Pharmaceuticals Welcomes Dr. Stephen Harrison to its Scientific Advisory Board

 

EDISON, N.J., August 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”) and chronic viral infection, today announced that Dr. Stephen Harrison has joined its Scientific Advisory Board.

 

“We are honored to have Dr. Harrison, an internationally recognized hepatologist (liver disease expert), join our Scientific Advisory Board,” commented Dr. Carol Brosgart, Clinical Professor of Medicine in the Divisions of Global Health Sciences, Biostatistics and Epidemiology in the Department of Medicine at the University of California, San Francisco and Chair of the Company’s Scientific Advisory Board. “With his extensive experience in chronic hepatitis and fatty liver disease, or NAFLD, and NASH, Dr. Harrison joins us at an opportune time, as we prepare for CRV431 to enter the clinic as a potential treatment for NASH and continue to progress its clinical development more broadly in liver disease.”

 

“I am looking forward to working with the Hepion team to develop CRV431, a promising candidate with the potential to treat not only hepatitis and NASH, but other diseases in which fibrosis plays a role,” commented Dr. Harrison.

 

Dr. Harrison is currently a Visiting Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford. He is also the Medical Director for Pinnacle Clinical Research and the President of Summit Clinical Research.

 

Dr. Harrison is a peer-reviewer for more than 20 medical journals. He is internationally known for studies in hepatitis C and non-alcoholic fatty liver disease with more than 200 peer reviewed publications in these fields. Dr. Harrison previously served as a Professor of Medicine at the Uniformed Services University of the Health Sciences and as Associate Editor for Hepatology and Alimentary Pharmacology and Therapeutics. Most recently, Dr. Harrison served as a Colonel in the United States Army, retiring in 2016 to conclude 20 years of dedicated service to his country. During his army tenure, he served as the Director of Graduate Medical Education at Brooke Army Medical Center, Associate Dean for the San Antonio Uniformed Services Health Education Consortium, and Gastroenterology Consultant to the Army Surgeon General.

 

Dr. Harrison earned his medical degree from the University of Mississippi School of Medicine. He completed his internal medicine residency and gastroenterology fellowship at Brooke Army Medical Center and a 4th year advanced liver disease fellowship at Saint Louis University. He is board certified in both Internal Medicine and Gastroenterology.

 

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 chronic hepatitis virus infection (HBV, HCV, HDV). 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 cyclophilin enzymes, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an

 

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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

 

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