Financial Performance - Total revenues and other income for the half-year ended June 30, 2024, amounted to €61,199, a significant increase from €15,374 in the same period in 2023, representing a growth of approximately 297%[37]. - Revenue for the half-year ended June 30, 2024, was €58,973, compared to €11,482 for the same period in 2023, indicating a growth of about 414%[38]. - The licensing agreement with Ipsen contributed €48.7 million in milestone revenue following the first commercial sale of Iqirvo®/elafibranor in the U.S. during the first six months of 2024[38]. - The company reported a net profit of €30.3 million for the first half of 2024, compared to a net loss of €20.9 million in the first half of 2023[53]. - Cash flow used in operating activities improved to an outflow of €11.2 million in the first half of 2024 from an outflow of €25.1 million in the first half of 2023[55][56]. - The company recorded a net loss of €28,894 thousand for the year ended December 31, 2023, compared to a net loss of €23,719 thousand for the year ended December 31, 2022[142]. - The company has never generated significant recurring revenue from product sales and does not expect to achieve profitability in the foreseeable future[141]. - The company reported a decrease in cash and cash equivalents to €61,645 thousand at the end of June 30, 2024, down from €111,826 thousand at the beginning of the period[172]. Product Development and Approvals - Iqirvo®/elafibranor received U.S. FDA accelerated approval as a first-in-class treatment for Primary Biliary Cholangitis (PBC) on June 10, 2024[13]. - The approval of Iqirvo® is based on the reduction of alkaline phosphatase (ALP), with ongoing requirements for confirmatory trials to verify clinical benefits[15]. - The company is developing several drug candidates for ACLF, a condition with no approved treatments, increasing the risks associated with their clinical development[71]. - The FDA granted accelerated approval for Iqirvo®/elafibranor for the treatment of PBC in June 2024, but it is not approved in other territories[88]. - The company is exploring accelerated regulatory approval pathways for GNS561 in Cholangiocarcinoma and VS-01 in ACLF, leveraging Orphan Drug Designation from the FDA[101]. - The successful commercialization of Iqirvo®/elafibranor in PBC in the U.S. is crucial for the company's near and medium-term capital resources[102]. Research and Development - GENFIT's R&D pipeline includes five assets targeting Acute-on-Chronic Liver Failure (ACLF) and two assets for other life-threatening diseases[9]. - The company has a diversified R&D portfolio with a focus on rare liver diseases characterized by unmet medical needs[5]. - For the first half of 2024, research and development expenses totaled €19.0 million, a decrease from €25.6 million in the same period of 2023[43][44]. - The company is focused on developing innovative drugs and diagnostic tools for metabolic, inflammatory, autoimmune, and fibrotic diseases, particularly those affecting the liver[174]. Financial Outlook and Risks - GENFIT expects to receive future milestone revenue of approximately €26.5 million, in addition to €13.3 million and €48.7 million already received in February and August 2024, respectively[35]. - The company faces significant challenges in patient enrollment for clinical trials due to the rarity of conditions like ACLF and CCA, which may delay trial timelines[86]. - The company acknowledges that development failures can occur at any stage, impacting the ability to obtain regulatory approvals[79]. - The company may need to incur additional debt to meet future financing needs, which could affect its ability to repay existing obligations[161]. - The company has a history of recorded losses, except for the year ended December 31, 2021, and expects to continue incurring losses as it develops its product candidates[148]. Collaborations and Partnerships - Ipsen's licensing agreement for elafibranor includes milestone payments and royalties on sales, enhancing GENFIT's revenue stream[10]. - The collaboration with Ipsen has resulted in significant milestone payments linked to the development and commercialization of Iqirvo®/elafibranor in PBC, but there is no assurance of timely realization of these payments[143]. Market and Regulatory Environment - The commercial success of Iqirvo®/elafibranor will depend on acceptance among the medical community, given the limited number of approved treatments for PBC[118]. - Regulatory authorities may impose additional conditions or require more data before granting approvals, impacting the timeline for market entry[112]. - Government pricing restrictions and healthcare payor initiatives may negatively impact revenue generation even with regulatory approvals[122]. - The market acceptance of the company's product candidates will be influenced by competition, clinical safety, efficacy, and reimbursement availability[119].

131,000 shares €700 885.51 On the buy side: 2,256 On the sell side: 2,012 Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) July 9, 2024 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the half-year report of the liquidity contract with Crédit Industriel et Commercial. During this same period, the number of trades were: ABOUT GENFIT and our con ...

Core Points - GENFIT's NIS2+® has been included in the European Clinical Practice Guidelines for managing metabolic dysfunction-associated steatotic liver disease (MASLD), marking a significant recognition of its role in identifying at-risk patients [1][2][3] - The guidelines were developed collaboratively by the European Association for the Study of the Liver (EASL), the European Association for the Study of Diabetes (EASD), and the European Association for the Study of Obesity (EASO) [2] - NIS2+® is the only blood-based diagnostic tool mentioned for detecting at-risk MASH, emphasizing its importance in clinical practice as liver biopsy becomes less common due to its invasiveness [4] Company Overview - GENFIT is a late-stage biopharmaceutical company focused on rare and life-threatening liver diseases, with a diverse R&D portfolio targeting conditions like Acute-on-Chronic Liver Failure (ACLF) and cholangiocarcinoma [7][8] - The company has a strong history in liver disease research and has developed diagnostic technologies, including NIS2+®, which is designed to detect at-risk MASH among patients with metabolic risk factors [6][8] - GENFIT is listed on both Nasdaq and Euronext, and has received significant investment, including an 8% stake acquisition by Ipsen in 2021 [8]

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 29, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today detailed its presence at the EASL Congress™ 2024. GENFIT accelerates its research in Acute on-Chronic Liver Failure (ACLF) EF CLIF and GENFIT partnership event GENFIT will co-host an event with the European Foundation for the Study of Chronic L ...

Company Overview - GENFIT is a late-stage biopharmaceutical company focused on improving the lives of patients with rare and life-threatening liver diseases [3] - The company has a rich history in liver disease research and development, spanning over two decades [3] - GENFIT's R&D portfolio includes programs at various stages of development, particularly focusing on Acute-on-Chronic Liver Failure (ACLF) [3] Recent Shareholder Meeting - The Combined Shareholders Meeting took place on May 22, 2024, with a quorum of 27.25% [1] - All resolutions presented at the meeting were approved by the shareholders [1] Product Development - GENFIT's ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022, and VS-02-HE, utilizing different mechanisms of action [3] - The company also targets other serious diseases such as cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA) [3] - The success of the 52-week Phase 3 ELATIVE® study evaluating elafibranor in Primary Biliary Cholangitis (PBC) demonstrates GENFIT's expertise in developing high-potential molecules [3] Diagnostic Franchise - GENFIT has a diagnostic franchise that includes NIS2+® for Metabolic dysfunction-associated steatohepatitis (MASH) and TS-01 focusing on blood ammonia levels [3] Corporate Structure - GENFIT is headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA [3] - The company is listed on the Nasdaq Global Select Market and Euronext regulated market in Paris [3] - In 2021, Ipsen acquired an 8% stake in GENFIT, becoming one of its largest shareholders [3]

Exhibit 99.1 GENFIT Announces Publication of the 2023 Universal Registration Document and the 2023 Annual Report on Form 20-F GENFIT's 2023 Universal Registration Document includes, in particular: ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanni ...

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 ...

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 ...

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].

| 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 ...