HEPA Hepion Pharmaceuticals Inc

Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-assisted therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, announced that Stephen Harrison, M.D., has been appointed as Consultant Medical Director. Dr. Harrison, the current Chairman of Hepion’s Scientific Advisory Board (“SAB”), succeeds Todd Hobbs, M.D., who has provided notice to the Company of his resignation as Chief Medical Officer, effective September 29, 2023.

Dr. Harrison previously served as Hepion’s Consultant Medical Director from October 2019 until February 2021. He is currently a Visiting Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford. He is internationally known for studies in NAFLD/NASH (particularly drug development) with over 300 peer-reviewed publications and an H Index of 101. Dr. Harrison currently serves as the founder and chairman for both Pinnacle Clinical Research and Summit Clinical Research (an internationally recognized integrated research organization with over 100 sites worldwide) in San Antonio, Texas. He is the lead Principal Investigator for numerous NASH development programs.

“In the time that we have worked together, Dr. Hobbs has earned my deep personal admiration and great professional respect, and I thank him for his many contributions to the advancement of rencofilstat,” said Hepion’s Chief Executive Officer, Robert Foster, PharmD, PhD. “I wish him all the best in his future endeavors. At the same time, I am pleased that our medical strategy and clinical development organization will be in the extremely capable hands of Dr. Harrison, a world-renowned expert in chronic hepatitis, fatty liver disease and NASH.”

Dr. Harrison commented, “Rencofilstat, a cyclophilin inhibitor, is a novel compound that is being developed for NASH and advanced fibrosis, as well as hepatocellular carcinoma. In my role as the Chairman of the Hepion SAB, I have been impressed with the clinical non-invasive data generated to date and believe this oral, once daily, novel therapy could have a significant positive impact on patient’s lives suffering from these two diseases. The Company is at an important crossroads with enrollment in a pivotal Phase 2b trial in NASH ongoing. I am happy to step up to the Consulting Medical Director role to help navigate Hepion through this important time.”

About Hepion Pharmaceuticals

The Company’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was followed in June 2022 by the FDA’s granting of Orphan Drug designation to rencofilstat for the treatment of HCC.

Hepion has created a proprietary Artificial Intelligence deep machine learning (“AI/ML”) platform designed to better understand disease processes and identify patients that are rencofilstat responders. This AI/ML has the potential to shorten development timelines and increase the observable differences between placebo and treatment groups. In addition, Hepion’s AI/ML can be used to drive its ongoing NASH and HCC clinical development programs and identify other potential therapeutic indications for cyclophilin inhibition with rencofilstat.

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, 2022, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Stephen KilmerHepion Pharmaceuticals Investor RelationsDirect: (646) 274-3580skilmer@hepionpharma.com