Genfit(GNFT) - 2021 Q4 - Annual Report

GENFIT 2021 Annual Report Filing and Corporate Update Announcement of Financial Report Filing and Shareholders Meeting GENFIT announced the filing of its 2021 Universal Registration Document and Annual Report on Form 20-F, with preparatory documents for the May 25, 2022, Annual Shareholders Meeting now available - GENFIT filed its 2021 Universal Registration Document with the AMF and its Annual Report on Form 20-F with the SEC on April 29, 2022[2] - The 2021 Universal Registration Document encompasses the annual financial report, management report, corporate governance report, and auditors' reports[4] - Preparatory documents for the Annual Combined Shareholders Meeting on May 25, 2022, are accessible to shareholders via the company's website[5] Company Overview and R&D Pipeline GENFIT is a late-stage biopharmaceutical company focused on severe chronic liver diseases, with R&D in cholestatic diseases, ACLF, and NASH diagnostics, featuring a diversified pipeline and key partnerships - GENFIT's R&D focuses on three franchises: cholestatic diseases, Acute on Chronic Liver Failure (ACLF), and NASH diagnostics[8] Pipeline Overview | Pipeline / Product | Indication | Phase / Status | Key Partner / Agreement | | :--- | :--- | :--- | :--- | | Elafibranor (ELATIVE™) | Primary Biliary Cholangitis (PBC) | Phase 3 | Ipsen (Develop, manufacture, commercialize) | | GNS561 | Cholangiocarcinoma | Development | Genoscience Pharma (Exclusive rights) | | Nitazoxanide | ACLF | Phase 1 | - | | NASHnext® (NIS4®) | At-risk NASH Identification | Commercialization | Labcorp | - In 2021, Ipsen became a major shareholder, holding 8% of GENFIT's share capital[9] - Topline data for the Phase 3 trial of elafibranor in PBC is anticipated in early 2023, with Phase 1 nitazoxanide data in ACLF expected as early as Q3 2022[8] Forward-Looking Statements and Risk Factors The press release contains forward-looking statements regarding R&D programs and clinical trial results, subject to risks detailed in public filings with the AMF and SEC - The document contains forward-looking statements concerning R&D programs and clinical trial data readouts, which do not guarantee future performance[10] - Investors should refer to the company's public filings, including Chapter 2 of the 2021 Universal Registration Document (D.22-0400) and the 2021 Annual Report on Form 20-F, for a comprehensive list of risks and uncertainties[10]