8-K - HEPA - Equibles

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 10, 2021

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 November 10, 2021, Hepion Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that results from its Phase 2a ‘AMBITION’ NASH trial will be available as an e-poster at the Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD), to be held virtually November 12-15, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

In addition, the Company issued a press release announcing that results from a study conducted by Dr. Philippe Gallay’s research group at The Scripps Research Institute examining the anti-tumor mechanism of the Company’s lead drug candidate, CRV431, will be available as an e-poster at the Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD), to be held virtually November 12-15, 2021. A copy of the press release is furnished as Exhibit 99.2 to this Form 8-K.

Item 9.01	Financial Statements and Exhibits ****
(d) Exhibits
99.1	Hepion Pharmaceuticals, Inc. Press Release dated November 10, 2021
99.2	Hepion Pharmaceuticals, Inc. Press Release dated November 10, 2021

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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: November 10, 2021

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

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Exhibit 99.1

Hepion Pharmaceuticals AnnouncesPoster Details for the Upcoming AASLD The Liver Meeting® 2021

EDISON,N.J.****, November 10, 2021 - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and other liver diseases, today announced that results from its Phase 2a ‘AMBITION’ NASH trial will be available as an e-poster at the Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD), to be held virtually November 12-15, 2021.

Poster Details

·	Poster #: 1872
·	Title: Investigating CRV431 in NASHPatients: Data from the Phase 2a AMBITIOIN Study
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·	Session: 2304 - NAFLD AND NASH: EXPERIMENTAL:<br>CLINICAL
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·	Lead Author: Stephen Harrison, MD, Medical<br>Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University.
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The meeting platform with posters is now open and the e-poster is also available on the publications page of the Company’s website.

About the Phase 2a AMBITIONClinical Trial

AMBITION, a multicenter, randomized, placebo controlled, single-blind Phase 2a trial, enrolled 43 NASH patients. The trial was designed to investigate once daily oral administration of CRV431 at doses of 75 mg (n=12) and 225 mg (n=17) administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days, followed by a 14-day observation period for safety.

All primary endpoints of the AMBITION NASH trial (safety, tolerability and pharmacokinetics) were met, and changes in select biomarkers indicated efficacy of CRV431.

About Hepion Pharmaceuticals

The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.

Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.

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, 2020, 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

Exhibit 99.2

Anti-Cancer Mechanism of HepionPharmaceuticals’ CRV431 Highlighted in Scripps Research Institute Poster at AASLD, The Liver Meeting® 2021

EDISON,N.J.****, November 10, 2021 - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and other liver diseases, today announced that results from a study conducted by Dr. Philippe Gallay’s research group at The Scripps Research Institute examing the anti-tumor mechanism of the Company’s lead drug candidate, CRV431, will be available as an e-poster at the Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD), to be held virtually November 12-15, 2021.

Poster Details

·	Poster #: 1768
·	Title: Cyclophilin D Knockout Significantly<br>Prevents HCC Development in a Streptozotocin-Induced Mouse Model of Diabetes-Linked NASH
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·	Session: NAFLD and NASH
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·	Authors: Stauffer, W.; Kuo, J.; Ure, D.;<br>Foster, R.; Gallay, P.
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About the Study

This animal model recapitulates NASH and, over a longer period of time, induces hepatocellular carcinoma (HCC), the most prevalent type of liver cancer observed in NASH. Cyclophilin inhibition utilizing therapeutic agents, including Hepion’s investigational drug candidate CRV431, have previously been shown to reduce tumor burdern in this model.

CRV431 inhibits many of the iso-forms of cyclophilins, enzymes involved in key aspects of disease progression. One of these important isoforms, cyclophilin D, was investigated at the Gallay Laboratory at Scripps Research Institute in mice lacking cyclophilin D. This particular isoform is an important component of the mitochondrial permeability transition pore and has a role in cell injury and death.

Wild type mice (not lacking in cyclophilin D) had HCC tumor burden scores that were three times greater than mice lacking cyclophilin D (p = 0.03). The study concluded that cyclophilin inhibition represents a novel class of compounds to treat HCC and that reductions in cyclophilin D are significantly protected from HCC.