Core Insights - Hepion Pharmaceuticals has appointed Dr. Kaouthar Lbiati as interim CEO, effective June 16, 2025, replacing John Brancaccio who is retiring for personal reasons [1][2] - Dr. Lbiati's leadership is expected to focus on strategic renewal and innovation in diagnostics for unmet clinical needs, including celiac disease, respiratory multiplex testing, H. pylori, and HCC [2][4] - Dr. Lbiati has over 15 years of experience in biotech and pharmaceuticals, having held significant roles in advancing therapies from preclinical development to commercialization [3] Company Strategy - The company aims to reposition itself as a leader in precision diagnostics, targeting underdiagnosed conditions and leveraging scalable technologies [4] - Hepion plans to prioritize immediate revenue generation and long-term innovation, focusing on clinical utility for patients at risk of liver cancer and their caregivers [4] Recent Developments - In April 2024, Hepion announced the winding down of its ASCEND-NASH clinical trial, which had a target enrollment of 336 subjects but was paused with 151 subjects randomized [6] - On May 26, 2025, Hepion entered into an agreement to sell all patent assets and related data for Rencofilstat for a nominal amount, along with a contingent value right for stockholders [7]

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]