Hepion Pharmaceuticals (HEPA)

Executive Summary

Hepion Pharmaceuticals (OTCQB: HEPA) is a clinical-stage biopharmaceutical company focused on liver diseases and early cancer detection. The company's lead drug candidate, rencofilstat (CRV431), is a cyclophilin inhibitor being developed for nonalcoholic steatohepatitis (NASH) and fibrosis. Hepion recently completed multiple Phase 2 trials, including a 2025 study (NCT05402371) evaluating rencofilstat in NASH patients. Additionally, Hepion has expanded into liquid biopsy diagnostics through the acquisition of a methylated DNA (SEPT9) test for early hepatocellular carcinoma (HCC) detection and a circulating tumor RNA (ctRNA) platform with broader potential. This dual strategy positions Hepion to address both therapeutic and diagnostic needs in liver disease, though the NASH pipeline faces intense competition. With a small market capitalization and no approved products, the company's near-term value hinges on successful commercialization of the HCC diagnostic and positive rencofilstat data that can support further development or partnership.

Upcoming Catalysts (preview)

• Q4 2025Rencofilstat Phase 2 NASH Data Readout40% success
• Q3 2026Commercial Launch of SEPT9 HCC Liquid Biopsy Test60% success
• H2 2026Partnership or Licensing Deal for ctRNA Platform50% success