Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA)

Hepa 2 year chart 11/22/2019

Can Hepion Pharmaceuticals (Nasdaq:hepa) make a huge comeback, There is a lot of room for the stock to rebound.

Business Overview

Hepion Pharmaceuticals, Inc. (“Hepion” or the “Company”) is a biopharmaceutical company headquartered in Edison, New Jersey, focused on the development of pleiotropic drug therapy for treatment of chronic liver disease. This therapeutic approach targets fibrosis and hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. The Company’s cyclophilin inhibitor, CRV431, is being developed to offer benefits to address these multiple complex pathologies. CRV431 is a cyclophilin inhibitor that targets multiple biochemical pathways involved in the progression of liver disease. Preclinical studies with CRV431 in NASH models demonstrated consistent reductions in liver inflammation, fibrosis, and cancerous tumors. CRV431 additionally shows antiviral activity towards hepatitis B, C, and D viruses which also trigger liver disease.

On July 18, 2019, the Company filed a certificate of amendment (the “Certificate of Amendment”) to the Company’s certificate of incorporation (the “Certificate”) to change the Company’s name from “ContraVir Pharmaceuticals, Inc.” to “Hepion Pharmaceuticals, Inc.” The name change became effective as of July 18, 2019.

The Company is developing CRV431 as its lead molecule. CRV431 is a cyclophilin inhibitor that targets specific isomerases that play an important role in protein folding in health and in disease. To date, in vitro and/or in vivo studies have demonstrated reductions in HBV DNA, HBsAg, HBeAg, inhibition of virus uptake (NTCP transport inhibition), and stimulation of innate immunity. Importantly, in vivo studies in a NASH model of fibrosis and HCC have repeatedly demonstrated CRV431 reduces fibrosis scores and overall liver tumor burden. Hence, CRV431 is a pleiotropic molecule that may not only treat liver disease but may also serve to reduce important risk factors (e.g., HBV) for developing the disease. The Company has completed a phase 1 study with CRV431 demonstrating safety, tolerability, and pharmacokinetics (PK).

HEPION PHARMACEUTICALS, INC. (NASDAQ:HEPA)

(Exact name of registrant as specified in its charter)

Delaware 46-2783806
(State or Other Jurisdiction of (I.R.S. Employer Identification No.)
Incorporation or Organization)  

0399 Thornall Street, First Floor, Edison, New Jersey 
(Address of principal executive offices)

08837 
(Zip Code)

(732) 902-4000

HEPA Recent News

Hepion Rips Higher After NASH Drug Confirms Antifibrotic Activity In Animal Study

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

Hepion Pharmaceuticals Announces Dosing of First HBV Patient in 28-Day Study of CRV431

Hepion Pharmaceuticals Announces Research Partnership with Applied Pharmaceutical Innovation, Faculty of Pharmacy & Pharmaceutical Sciences at University of Alberta

(NASDAQ:HEPA) Pertinent information from Hepion Pharmaceutical From Sec Filings on 11/14/19.

On May 10, 2018, the Company submitted an Investigational New Drug Application (“IND”) to the U.S. Food and Drug Administration (“FDA”) to support initiation of the Company’s CRV431 HBV clinical development program in the United States and received approval in June 2018. The Company completed the first segment of Phase 1 clinical activities for CRV431 in October 2018 wherein the Company reached a major clinical milestone of positive data from a Phase I trial of CRV431 in humans. This achievement triggered the first milestone payment, as stated in the Merger Agreement for the acquisition of Ciclofilin Pharmaceuticals, Inc. (“Ciclofilin”) and the Company paid a related milestone payment of $1,000,000 and issued 1,439 shares of the Company’s common stock with a fair value of $55,398, representing 2.5% of the Company’s issued and outstanding common stock as of June 2016, to the Ciclofilin shareholders.

On June 17, 2019, the Company submitted an IND to the FDA to support initiation of the Company’s CRV431 NASH clinical development program in the United States and received approval in July 2019.

On December 18, 2014, the Company and Chimerix, Inc. (“Chimerix”), entered into a Licensing Agreement pursuant to which it licensed CMX157 (now known as tenofovir exalidex, “TXL”) from Chimerix for further clinical development and commercialization for an upfront payment of 120,000 shares of our preferred stock, valued at $1.2 million.

The termination of the License Agreement became effective on June 1, 2019. Upon the effectiveness of the termination of the License Agreement, Chimerix reacquired all worldwide rights to TXL. The Company made the decision to terminate the License Agreement following the decision to no longer pursue development of TXL, and to focus the Company’s resources and development programs on further advancing CRV431. The Company does not owe any fees or payments to Chimerix.

These unaudited condensed consolidated financial statements have been prepared following the requirements of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim reporting. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s interim financial information. The condensed consolidated balance sheet as of December 31, 2018 was derived from the audited annual consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2018 contained in the Company’s Annual Report on Form 10-K (“Form 10-K”) filed with the SEC on March 14, 2019.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of Hepion and the Company’s subsidiaries, Hepion Research Inc. and Hepion Research Corp, which conducts its operations in Canada. All intercompany balances and transactions have been eliminated in consolidation.

Reverse Stock Split

On May 28, 2019, the Company effected a 1 for 70 reverse stock split of the Company’s common stock. The par value and the number of authorized shares of the common and convertible preferred stock were not adjusted as a result of the reverse stock split. All common stock share and per-share amounts for all periods presented in these financial statements have been adjusted retroactively to reflect the reverse stock split.

Going Concern

As of September 30, 2019, the Company had $14.9 million in cash. Net cash used in operating activities was $5.1 million for the nine months ended September 30, 2019. Net loss for the nine months ended September 30, 2019 was $4.8 million. As of September 30, 2019, the Company had working capital of $13.7 million. The Company has not generated revenue to date and has incurred substantial losses and negative cash flows from operations since inception. The Company has historically funded operations through issuances of convertible debt, common stock and preferred stock. The Company expects to continue to incur losses for the next several years as it expands research, development and clinical trials of CRV431. The Company is unable to predict the extent of any future losses or when the Company will become profitable, if at all.

These condensed consolidated financial statements have been prepared under the assumption that the Company will continue as a going concern. Due to the Company’s recurring and expected continuing losses from operations, the Company has concluded there is substantial doubt in the Company’s ability to continue as a going concern within one year of the issuance of these condensed consolidated financial statements without additional capital becoming available to attain further operating efficiencies and, ultimately, to generate revenue. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The Company will be required to raise additional capital within the next year to continue the development and commercialization of current product candidates and to continue to fund operations at the current cash expenditure levels. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’s ability to conduct business. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may have to (i) significantly delay, scale back or discontinue the development and/or commercialization of one or more product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that the Company would otherwise seek to develop or commercialize on unfavorable terms.

3. Summary of Significant Accounting Policies

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. Actual results could differ from those estimates.

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2018 included in the Company’s Form 10-K filed with the SEC on March 14, 2019. Since the date of such consolidated financial statements, there have been no changes to the Company’s significant accounting policies.

Cash

As of September 30, 2019, and December 31, 2018, the amount of cash was approximately $14.9 million and $2.8 million, respectively, consisting primarily of checking accounts held at U.S. and Canadian commercial banks. Cash is maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced losses related to these balances.

As of September 30, 2019, we had an accumulated deficit of $81.3 million, and expect to incur significant and increasing operating losses for the next several years as we expand our research, development and clinical trials of CRV431. We are unable to predict the extent of any future losses or when we will become profitable, if at all.

Our unaudited condensed consolidated financial statements as of September 30, 2019 have been prepared under the assumption that we will continue as a going concern within one year of the issuance of these condensed consolidated financial statements, contemplates the realization of assets and satisfaction of liabilities in the normal course of business and do not include any

Hepion Pharmaceuticals will be a strong play to watch for the next 1 to 2 years as they appears to have major developments coming their way, Interesting company as they have gotten themselves in a position to make a major impact in their field of focus. Recent News really has the stock soaring, but how high can she revover to? we will keep watching it.

Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA)

6 month chart

(Nasdaq:hepa) 6 month chart 11/22/19

On November 20, 2019, Hepion Pharmaceuticals, Inc. issued a press release announcing that CRV431, an anti-fibrotic agent, prevented the development of liver cirrhosis in a highly aggressive, preclinical model of liver disease. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

Most recent developments on 11/20/19

Hepion Pharmaceuticals’ CRV431 Prevents Cirrhosis in Experimental Model of Severe Liver Disease

EDISON, N.J.,November 20, 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 CRV431, an anti-fibrotic agent, prevented the development of liver cirrhosis in a highly aggressive, preclinical model of liver disease.

In this study, conducted by Physiogenex, S.A.S. (France), rats were administered the hepatotoxic compound, thioacetamide, for nine weeks to induce liver injury and fibrosis, in combination with either CRV431 or vehicle control for the entire study period. Blinded, histopathological analysis of the livers was conducted at the end of the study period.

In the vehicle control group, 50% (5 out of 10) of the animals developed cirrhosis, a severe form of liver disease that includes maximum levels of fibrotic scarring (F4 fibrosis; Kleiner scoring system). In contrast, none of the 10 CRV431-treated rats developed cirrhosis. Quantification of Sirius Red histological staining, another measure of fibrotic scarring, similarly revealed a mean reduction in the CRV431 treatment group of 49% compared to the vehicle control group, which was statistically significant (p = 0.008). These results suggest that the anti-fibrotic activity of CRV431 was primarily responsible for attenuating the progression to cirrhosis over the duration of the study.

“These findings are an important preclinical milestone for CRV431 because thioacetamide administration to rats is recognized to produce among the most severe liver disease of all experimental models. This model was a rigorous test of CRV431’s anti-fibrotic activity,” said Dr. Robert Foster, Chief Executive Officer of Hepion. “The results align with previous findings in other experimental models and highlight the tremendous potential of CRV431 as a treatment for liver diseases, including NASH, where progression to cirrhosis is a primary medical concern. Every fibrosis study that we have conducted thus far, whether in animals or in human liver slices, has demonstrated CRV431’s strong anti-fibrotic activity, contributing to a body of preclinical efficacy data that complements our ongoing human clinical trials.” 

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.

These recent developments have hepa’s stock rapidly increasing its share value, here is the 5 day chart

(Nasdaq:hepa) 5 day chart 11/22/19

Can this uptrend Continue?

We will keep our eyes on hepa and their research as they come forth with more significant news?

FIND MORE HEPA NEWS HERE

the upcoming results as they take on more trials will be of significant. we will keep watching hepa. More Major news could push the stock far up. Looking good for the next 1 to 2 years as their research seems to be showing some possible significant results.