MORRISTOWN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (OTC:HEPA), a clinical stage biopharmaceutical company that is developing and commercializing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC), today announced that Dr. Kaouthar Lbiati has been named as interim Chief Executive Officer, effective June 16, 2025. Dr. Lbiati is replacing John Brancaccio, who is retiring for p ...

Core Viewpoint - Hepion Pharmaceuticals has transitioned from developing treatments for chronic liver diseases to focusing on diagnostic tests, while facing delisting from Nasdaq due to non-compliance with listing standards [1][2]. Company Overview - Hepion Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that was previously developing treatments for non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) [1]. - The company's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown efficacy in reducing liver fibrosis and HCC tumor burden in experimental models [3]. Recent Developments - On May 9, 2025, the company received a notice from Nasdaq indicating that its shares would be delisted due to failure to maintain a minimum bid price of $1.00 per share and being classified as a public shell [1]. - Following the suspension of trading on Nasdaq, the company's shares are expected to be quoted on the OTC Markets Group under the existing symbol "HEPA" [2]. - Hepion announced a license agreement with New Day Diagnostics LLC on May 9, 2025, to in-license diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori, and HCC, with some tests already having CE marks for sale in Europe [5]. Clinical Trials - In April 2024, Hepion decided to wind down its ASCEND-NASH clinical trial, which was a Phase 2b study aimed at evaluating the safety and efficacy of Rencofilstat over 12 months, with a target enrollment of 336 subjects [4]. - Enrollment in the trial was paused in April 2023 after 151 subjects were randomized, and approximately 80 subjects have completed their Day 365 visits [4].

Core Insights - Hepion Pharmaceuticals has entered into a binding letter of intent with New Day Diagnostics to in-license diagnostic tests for various diseases, including celiac disease and hepatocellular carcinoma [1][2][3] - The combined addressable market for these diagnostic tests exceeds $15 billion, with significant growth projections across multiple segments [2] Company Developments - The diagnostic tests include CE-marked products that are eligible for sale in Europe, allowing Hepion to generate near-term revenues through existing distributor networks [3] - Hepion's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown efficacy in reducing liver fibrosis and tumor burden in experimental models [4] - The company previously announced the winding down of its ASCEND-NASH clinical trial, which was paused in April 2023 after randomizing 151 subjects [5][6] Market Opportunities - The Respiratory Panel RT-PCR Multiplex CE-IVD targets a $5.6 billion market, growing at 6.6% annually through 2029, while the H. pylori test addresses a $700 million market with a 6.0% growth rate projected through 2032 [2] - The celiac disease screening test operates in a $457 million market, expected to grow at 10.4% annually through 2034, and the mSEPT9 assay for HCC detection serves an $8.7 billion market with a 6.7% growth rate projected through 2030 [2]

Core Insights - Hepion Pharmaceuticals has entered into a binding letter of intent with New Day Diagnostics to in-license diagnostic tests for various diseases, including celiac disease and hepatocellular carcinoma [1][2][3] - The combined addressable market for these diagnostic tests exceeds $15 billion, with significant growth projections across multiple segments [2] Company Developments - The diagnostic tests include CE-marked products that are eligible for sale in Europe, allowing Hepion to generate near-term revenues through existing distributor networks [3] - Hepion's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown promise in reducing liver fibrosis and tumor burden in experimental models [4] - The company previously announced the winding down of its ASCEND-NASH clinical trial, which was paused in April 2023 after randomizing 151 subjects [5] Market Opportunities - The Respiratory Panel RT-PCR Multiplex CE-IVD targets a $5.6 billion market, growing at 6.6% annually through 2029 [2] - The H. pylori CE-IVD addresses a $700 million market with a projected growth rate of 6.0% through 2032 [2] - The CeliaCare CE-IVD supports a $457 million market growing at 10.4% annually through 2034 [2] - The mSEPT9 assay for early detection of hepatocellular carcinoma serves an $8.7 billion market projected to grow at 6.7% annually through 2030 [2] Strategic Partnerships - The partnership with New Day Diagnostics is viewed as a strategic step to enhance the accessibility of high-impact diagnostics globally [3][6] - The collaboration aims to expand the reach of CE-marked tests into the United States, unlocking new opportunities for early detection and improved patient outcomes [3]