Hepion Pharmaceuticals Business Summary

Hepion Pharmaceuticals, Inc. (OTC: HEPA) is a clinical-stage biopharmaceutical company that has strategically pivoted from drug development to the commercialization of precision diagnostics. Following the 2025 wind-down of its Phase 2b ASCEND-NASH trial and the subsequent sale of its lead drug candidate, rencofilstat, the company now generates revenue through the development and licensing of diagnostic tests. Its primary business segment focuses on in-licensed diagnostic solutions from New Day Diagnostics LLC, targeting celiac disease, respiratory multiplex infections (COVID-19, Influenza A/B, RSV), Helicobacter pylori, and hepatocellular carcinoma (HCC). Hepion competes in the specialized medical diagnostics and pharmaceutical services market against peers such as Ensysce Biosciences, Onconetix, and Universe Pharmaceuticals, positioning itself as a niche provider of AI-driven diagnostic tools for chronic liver and infectious diseases. Leadership is currently headed by Dr. Kaouthar Lbiati, who was appointed as Chief Executive Officer in January 2026 after serving as interim CEO since mid-2025. Dr. Lbiati is a medical doctor with over 15 years of executive experience at global pharmaceutical leaders including Sanofi, GlaxoSmithKline, and Amgen, specializing in global commercialization and regulatory strategy. The technical vision is supported by Chief Scientific Officer Dr. Daren Ure, a renowned expert in cyclophilin research and former Director of R&D at Ciclofilin Pharmaceuticals. The company’s board of directors includes notable industry figures such as Dr. Timothy Block, co-founder of the Hepatitis B Foundation, and John Brancaccio, providing a foundation of deep clinical and financial expertise as the firm transitions into its diagnostic-centric commercial phase.