Genfit(GNFT)

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Genfit(GNFT) - 2023 Q4 - Annual Report
2024-04-05 15:44
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
Genfit(GNFT) - 2023 Q2 - Quarterly Report
2023-06-30 10:00
Exhibit 99.1 Ipsen and GENFIT Announce Positive Results from Phase III ELATIVE® trial of elafibranor in patients with primary biliary cholangitis, a rare cholestatic liver disease Paris (France); June 30, 2023 - Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced positive topline data from the pivotal ELATIVE® Phase III trial. In the trial the efficacy and safety of elafibranor, an investigational dual α,δ PPAR agonist, is being assessed for the treatment of patients wit ...
Genfit(GNFT) - 2022 Q4 - Annual Report
2023-04-18 20:10
Financial Reporting - GENFIT filed its 2022 Universal Registration Document and Annual Report on Form 20-F with the AMF and SEC, respectively, for the year ended December 31, 2022[1]. - The 2022 Universal Registration Document includes the annual financial report and management report, among other key documents[5]. - The 2022 reports are publicly available for free on GENFIT's website and the AMF and SEC websites[2]. Company Focus and Pipeline - GENFIT is focused on improving the lives of patients with severe liver diseases characterized by high unmet medical needs[3]. - The company has a diversified pipeline covering six therapeutic areas, including acute on-chronic liver failure and hepatic encephalopathy, with programs at various development stages[4]. - The company is engaged in research and development of innovative therapeutic and diagnostic solutions, particularly for NASH and ACLF[4]. Shareholder Information - IPSEN holds 8% of GENFIT's share capital, making it one of the largest shareholders[6]. Risks and Forward-Looking Statements - Forward-looking statements indicate potential risks related to R&D, regulatory approvals, and market conditions that could impact future performance[6]. International Presence and Integration - GENFIT's facilities are located in Lille, Paris, Zurich, and Cambridge, MA, indicating a strong international presence[6]. - The company emphasizes its commitment to integrating assets from acquisitions, such as Versantis, to enhance its development capabilities[6].
Genfit(GNFT) - 2022 Q4 - Annual Report
2023-04-18 17:55
| UNITED STATES | | --- | | SECURITIES AND EXCHANGE COMMISSION | | WASHINGTON, D.C. 20549 | | FORM 20-F | | (Mark One) | | o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 | | OR | | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | x | | For the fiscal year ended December 31, 2022 | | OR | | o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | OR | | o SHELL COMPANY REPORT PURSUA ...
Genfit(GNFT) - 2021 Q4 - Annual Report
2022-04-29 20:10
[GENFIT 2021 Annual Report Filing and Corporate Update](index=1&type=section&id=GENFIT%20Announces%20Publication%20of%20the%202021%20Universal%20Registration%20Document%3B%20the%202021%20Annual%20Report%20on%20Form%2020-F%20and%20Availability%20of%20Preparatory%20Documents%20for%20the%20Annual%20Combined%20Shareholders%20Meeting%20on%20May%2025%2C%202022) [Announcement of Financial Report Filing and Shareholders Meeting](index=1&type=section&id=Announcement%20of%20Financial%20Report%20Filing%20and%20Shareholders%20Meeting) 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](index=2&type=chunk) - The 2021 Universal Registration Document encompasses the annual financial report, management report, corporate governance report, and auditors' reports[4](index=4&type=chunk) - Preparatory documents for the Annual Combined Shareholders Meeting on **May 25, 2022**, are accessible to shareholders via the company's website[5](index=5&type=chunk) [Company Overview and R&D Pipeline](index=1&type=section&id=ABOUT%20GENFIT) 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](index=8&type=chunk) 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](index=9&type=chunk) - 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](index=8&type=chunk) [Forward-Looking Statements and Risk Factors](index=3&type=section&id=FORWARD%20LOOKING%20STATEMENTS) 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](index=10&type=chunk) - 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](index=10&type=chunk)
Genfit (GNFT) Investor Presentation - Slideshow
2022-04-08 17:18
Corporate Presentation April 2022 Disclaimer & Looking Forward Statement IMPORTANT NOTICE – YOU MUST READ THE FOLLOWING BEFORE CONTINUING. THIS PRESENTATION HAS BEEN PREPARED BY GENFIT AND IS FOR INFORMATION PURPOSES ONLY. CERTAIN OF THE INFORMATION CONTAINED HEREIN CONCERNING ECONOMIC TRENDS AND PERFORMANCE IS BASED UPON OR DERIVED FROM INFORMATION PROVIDED BY THIRD-PARTY CONSULTANTS AND OTHER INDUSTRY SOURCES. WHILE GENFIT BELIEVES THAT SUCH INFORMATION IS ACCURATE AND THAT THE SOURCES FROM WHICH IT HAS B ...
Genfit(GNFT) - 2021 Q4 - Earnings Call Transcript
2022-04-08 14:24
Genfit SA (NASDAQ:GNFT) Q4 2021 Earnings Conference Call April 8, 2022 8:00 AM ET Company Participants Stefanie Magner - Deputy Director, Legal Affairs Pascal Prigent - Chief Executive Officer Tom Baetz - Chief Financial Officer Dean Hum - Chief Scientific Officer Carol Addy - Chief Medical Officer Conference Call Participants Thomas Smith - SVB Leerink Arsene Guekam - Kepler Cheuvreux Ed Arce - H.C. Wainwright Operator Good day, and welcome to the Genfit's Full-Year 2021 Financial Results and Corporate Upd ...
Genfit(GNFT) - 2020 Q4 - Annual Report
2021-04-23 15:54
| | | Page | | --- | --- | --- | | PART I | | 9 | | Item 1. | Identity of Director, Senior Management and Advisers | 9 | | Item 2. | Offer Statistics and Expected Timetable | 9 | | Item 3. | Key Information | 9 | | Item 4. | Information on the Company | 57 | | Item 5. | Operating and Financial Review and Prospects | 98 | | Item 6. | Directors, Senior Management and Employees | 116 | | Item 7. | Major Shareholders and Related Party Transactions | 138 | | Item 8. | Financial Information | 142 | | Item 9. | Th ...
Genfit(GNFT) - 2020 Q2 - Earnings Call Transcript
2020-10-01 01:49
GENFIT SA (NASDAQ:GNFT) Q2 2020 Results Conference Call September 30, 2020 4:30 PM ET Company Participants Stefanie Magner - Deputy Director, Legal Affairs Pascal Prigent - CEO Dean Hum - Chief Scientific Officer and COO Conference Call Participants Thomas Smith - SVB Leerink Derek Archila - Stifel Thomas Yip - H.C. Wainwright Operator Greetings and welcome to the GENFIT Half Year 2020 Financial Report and New Corporate Strategy Conference Call. At this time, all participants are in a listen-only mode. A qu ...
Genfit (GNFT) Investor Presentation - Slideshow
2020-08-31 17:44
June 19, 2020 2020 CORPORATE PRESENTATION 2020 Disclaimer & Forward Looking Statements IMPORTANT NOTICE – YOU MUST READ THE FOLLOWING BEFORE CONTINUING. THIS PRESENTATION HAS BEEN PREPARED BY GENFIT AND IS FOR INFORMATION PURPOSES ONLY. CERTAIN OF THE INFORMATION CONTAINED HEREIN CONCERNING ECONOMIC TRENDS AND PERFORMANCE IS BASED UPON OR DERIVED FROM INFORMATION PROVIDED BY THIRD-PARTY CONSULTANTS AND OTHER INDUSTRY SOURCES. WHILE GENFIT BELIEVES THAT SUCH INFORMATION IS ACCURATE AND THAT THE SOURCES FROM ...