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 ...

[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)

PART I [Key Information](index=7&type=section&id=Item%203%2E%20Key%20Information%2E) This section outlines significant business, operational, and financial risks, including dependency on elafibranor's PBC trial success and PFIC classification - The company's primary focus is on the development of **elafibranor for PBC**, following the clinical failure of its **Phase 3 RESOLVE-IT trial for elafibranor in NASH** in 2020[16](index=16&type=chunk)[25](index=25&type=chunk)[32](index=32&type=chunk) - GENFIT has licensed the **worldwide rights for elafibranor (excluding Greater China) to Ipsen**, and **rights for Greater China to Terns Pharmaceuticals**, remaining responsible for the **Phase 3 ELATIVE study for PBC** until the end of the double-blind period[25](index=25&type=chunk) - The company is developing **NIS4 technology** for the non-invasive diagnosis of NASH, with its commercialization partner Labcorp launching **NASHnext, a Laboratory Developed Test (LDT) powered by NIS4**, though its success is uncertain without an approved NASH treatment[60](index=60&type=chunk)[64](index=64&type=chunk) - The company has a history of **net losses** and only achieved **profitability in 2021** due to a **one-time upfront payment from Ipsen**, with future profitability uncertain and dependent on clinical programs and collaborations[17](index=17&type=chunk)[202](index=202&type=chunk) - Based on income and asset analysis, the company believes it was classified as a **Passive Foreign Investment Company (PFIC) for the taxable year ended December 31, 2021**, which can lead to **adverse U.S. federal income tax consequences** for U.S. holders[263](index=263&type=chunk)[844](index=844&type=chunk) [Information on the Company](index=48&type=section&id=Item%204%2E%20Information%20on%20the%20Company%2E) GENFIT, a late-stage biopharmaceutical company, refocused R&D on Cholestatic Diseases, ACLF, and Diagnostics, leveraging partnerships and third-party manufacturing - GENFIT has shifted its strategic focus to **three main franchises: Cholestatic Diseases, Acute on Chronic Liver Failure (ACLF), and Diagnostics**[285](index=285&type=chunk) GENFIT's R&D Pipeline Franchises | Cholestatic Diseases Franchise | ACLF Franchise | Diagnostic Franchise | | :--- | :--- | :--- | | **Primary Biliary Cholangitis (PBC):** elafibranor - Phase 3 ELATIVE | **ACLF:** nitazoxanide (NTZ) - Phase 1 | **NASH:** NIS4 Technology | - A **long-term strategic partnership was signed with Ipsen in December 2021** for the **global development and commercialization of elafibranor**, with Ipsen also acquiring an **8% equity stake** in GENFIT[298](index=298&type=chunk)[333](index=333&type=chunk)[335](index=335&type=chunk) - The company has **no manufacturing facilities** and relies entirely on **third-party Contract Manufacturing Organizations (CMOs)** for its drug candidates, including a **single supplier for the active ingredient in elafibranor**[425](index=425&type=chunk)[426](index=426&type=chunk) - As of March 31, 2022, GENFIT's intellectual property portfolio includes **43 issued U.S. patents** and **over 440 issued foreign patents across 60 patent families**, with **22 families related to elafibranor**[432](index=432&type=chunk) [Operating and Financial Review and Prospects](index=84&type=section&id=Item%205%2E%20Operating%20and%20Financial%20Review%20and%20Prospects%2E) 2021 financial performance saw a **€67.3 million net profit** driven by a **€120 million Ipsen upfront payment**, reduced R&D, and strengthened cash to **€258.8 million** Consolidated Statement of Operations Highlights (in € thousands) | Metric | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Revenue** | 80,069 | 765 | 30,839 | | **R&D Expenses** | (35,166) | (59,097) | (66,170) | | **Operating Income (Loss)** | 31,816 | (82,897) | (57,832) | | **Net Profit (Loss)** | 67,259 | (101,221) | (65,144) | - The **significant increase in 2021 revenue and net profit** was primarily driven by the recognition of **€80 million** from the **€120 million upfront payment** received from the licensing agreement with Ipsen[541](index=541&type=chunk)[559](index=559&type=chunk) Cash Flow Summary (in € thousands) | Cash Flow | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Operating Activities** | 99,915 | (96,371) | (47,680) | | **Investing Activities** | (3,377) | (966) | 327 | | **Financing Activities** | (8,916) | (8,256) | 116,860 | - In January 2021, the company **renegotiated its convertible bonds (OCEANEs)**, **extending maturity to October 2025**, **increasing the conversion ratio**, and completing a **partial buyback of 2,895,260 bonds for €47.48 million**[637](index=637&type=chunk)[638](index=638&type=chunk)[899](index=899&type=chunk) - **Cash and cash equivalents increased to €258.8 million** as of December 31, 2021, from **€171.0 million** at the end of 2020, bolstered by the Ipsen upfront payment and equity investment[610](index=610&type=chunk) [Directors, Senior Management and Employees](index=100&type=section&id=Item%206%2E%20Directors%2C%20Senior%20Management%20and%20Employees%2E) This section details GENFIT's board and senior management, including 2021 appointments, CEO compensation, equity incentive plans, and **122 employees** - As of December 31, 2021, GENFIT had **122 employees**, with **73** engaged in R&D and related activities[753](index=753&type=chunk) - In 2021, key management changes included the appointment of **Thomas Baetz as Chief Financial Officer** and **Stefanie Magner as Chief Compliance Officer**[650](index=650&type=chunk) 2021 CEO Compensation - Pascal Prigent | Component | Amount (€) | | :--- | :--- | | Fixed Compensation | 325,008 | | Variable Compensation | 162,504 | | Equity Awards | 58,400 | | All Other Compensation | 16,229 | | **Total** | **562,141** | - The company utilizes several **equity incentive plans, including Share Warrants (BSA), Free Shares (AGA), and Stock Options (SO)**, to compensate and retain directors, management, and employees[697](index=697&type=chunk) - The Board of Directors consists of **nine members and one board observer**, and as a **foreign private issuer**, GENFIT follows **French corporate governance practices in lieu of Nasdaq standards** regarding board independence and committee composition[725](index=725&type=chunk)[739](index=739&type=chunk) [Major Shareholders and Related Party Transactions](index=119&type=section&id=Item%207%2E%20Major%20Shareholders%20and%20Related%20Party%20Transactions%2E) This section identifies major shareholders, including Ipsen Pharma SAS with an **8% stake** and Biotech Avenir SAS with **3.79%**, and details key related party transactions - In December 2021, **Ipsen Pharma SAS became a major shareholder**, acquiring an **8% equity stake** in GENFIT through a **€28 million investment**[764](index=764&type=chunk)[800](index=800&type=chunk) - As of April 1, 2022, **Biotech Avenir SAS**, a holding company associated with the company's founders, beneficially owned **3.79%** of the ordinary shares[760](index=760&type=chunk)[769](index=769&type=chunk) - The **collaboration and license agreement with Ipsen**, a new major shareholder, is a **significant related party transaction**, with future service and supply agreements anticipated[773](index=773&type=chunk)[774](index=774&type=chunk) [Financial Information](index=123&type=section&id=Item%208%2E%20Financial%20Information%2E) This section confirms appended financial statements and discloses a significant shareholder class action lawsuit, currently under appeal - The company is defending against a purported **shareholder class action lawsuit** filed after the announcement of the **negative RESOLVE-IT trial results**, with the **initial case dismissed in August 2021**, but the **plaintiff's appeal was perfected in March 2022**[785](index=785&type=chunk)[786](index=786&type=chunk) - The company has **never declared or paid dividends** and **does not anticipate doing so in the foreseeable future**, intending to retain all earnings for business operations and expansion[782](index=782&type=chunk) [Additional Information](index=124&type=section&id=Item%2010%2E%20Additional%20Information%2E) This section details material contracts, including exclusive license agreements with Ipsen and Terns, and significant tax considerations, notably PFIC classification for 2021 - A key material contract is the **December 2021 exclusive collaboration and license agreement with Ipsen**, granting them **worldwide rights (ex-Greater China) to develop and commercialize elafibranor**, with GENFIT receiving a **€120 million upfront payment** and eligible for up to **€360 million in milestones plus royalties**[797](index=797&type=chunk)[798](index=798&type=chunk) - The company has a **collaboration and license agreement with Terns Pharmaceuticals**, granting them **exclusive rights to develop and commercialize elafibranor in Greater China** for NASH and PBC, with GENFIT receiving a **$35 million upfront payment** and eligible for up to **$193 million in milestones**[803](index=803&type=chunk)[804](index=804&type=chunk) - The company believes it was classified as a **Passive Foreign Investment Company (PFIC) for the taxable year ended December 31, 2021**, which has potentially **adverse U.S. federal income tax consequences** for U.S. holders of its securities[844](index=844&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=133&type=section&id=Item%2011%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk%2E) The primary market risk is foreign currency exchange due to **$81.7 million** in USD cash, with a **10% adverse change** potentially causing a **€6.6 million loss**, mitigated by natural hedging - The main market risk is **foreign currency exchange risk** due to holding **substantial cash reserves in U.S. dollars ($81.7 million at year-end 2021)** while operating primarily in euros[868](index=868&type=chunk)[870](index=870&type=chunk) - A hypothetical adverse **10% change** in the USD/EUR exchange rate would have resulted in a foreign exchange loss of approximately **€6.6 million** on the company's cash position as of December 31, 2021[870](index=870&type=chunk) - The company **does not use foreign exchange rate hedging tools**, instead maintaining a balance of euros and U.S. dollars to naturally cover projected outflows in each currency[872](index=872&type=chunk) - **Interest rate risk is considered low** as most financial liabilities are at fixed rates, and **liquidity risk is also deemed low**, with cash and equivalents of **€258.8 million** at year-end 2021 sufficient to fund operations for at least the next 12 months[875](index=875&type=chunk)[879](index=879&type=chunk)[880](index=880&type=chunk) PART II [Material Modifications to the Rights of Security Holders and Use of Proceeds](index=137&type=section&id=Item%2014%2E%20Material%20Modifications%20to%20the%20Rights%20of%20Security%20Holders%20and%20Use%20of%20Proceeds%2E) In January 2021, the company renegotiated its OCEANE convertible bonds, including a partial buyback for **€47.48 million**, extending maturity to October 2025, and increasing the conversion ratio - The company **successfully renegotiated its OCEANE convertible bonds in January 2021**[899](index=899&type=chunk)[900](index=900&type=chunk) - The renegotiation included a **partial buyback of outstanding bonds for €47.48 million** and amending the terms for the remainder[900](index=900&type=chunk) - Key amendments for the remaining bonds were an **extension of maturity to October 2025** and an **increase in the conversion ratio to 5.5 shares per bond**[899](index=899&type=chunk) [Disclosure Controls and Procedures](index=137&type=section&id=Item%2015%2E%20Disclosure%20Controls%20and%20Procedures%2E) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2021, with no material changes reported - The Principal Executive Officer and Principal Financial Officer concluded that the company's **disclosure controls and procedures were effective as of December 31, 2021**[904](index=904&type=chunk) - Management assessed **internal control over financial reporting** based on the **2013 COSO framework** and concluded it was **effective as of December 31, 2021**[906](index=906&type=chunk) - As an **emerging growth company**, this annual report **does not include an attestation report from the registered public accounting firm on internal control over financial reporting**[907](index=907&type=chunk) [Corporate Governance](index=139&type=section&id=Item%2016G%2E%20Corporate%20Governance%2E) As a French foreign private issuer, GENFIT follows home country corporate governance, differing from Nasdaq rules on board independence, committee composition, auditor appointment, and quorum - GENFIT, as a **foreign private issuer**, follows **French corporate governance practices instead of certain Nasdaq listing standards**[921](index=921&type=chunk) - Key differences from Nasdaq rules include **not requiring a majority-independent board of directors** and **not requiring the remuneration committee to be composed solely of independent directors**[921](index=921&type=chunk) - Under French law, the **audit committee's role in appointing statutory auditors is advisory**, with the **final decision made by shareholders** at the annual meeting[922](index=922&type=chunk) - Quorum requirements for shareholder meetings are governed by French law (e.g., **20% or 25%** of shares entitled to vote for a first call), which is different from the Nasdaq standard of **33 1/3%**[923](index=923&type=chunk) PART III [Financial Statements](index=141&type=section&id=Item%2017%2E%20Financial%20Statements%2E) This section presents the company's consolidated financial statements for 2019-2021, prepared under IFRS, including key financial statements and detailed notes Consolidated Statement of Financial Position (in € thousands) | | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | 281,720 | 198,119 | | **Total Liabilities** | 162,623 | 214,549 | | **Total Shareholders' Equity** | 119,097 | (16,430) | Consolidated Statement of Operations (in € thousands) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | **Revenues and other income** | 85,579 | 7,758 | | **Operating income (loss)** | 31,816 | (82,897) | | **Net profit (loss)** | 67,259 | (101,221) | Consolidated Statement of Cash Flows (in € thousands) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | **Cash flows from operating activities** | 99,915 | (96,371) | | **Cash and cash equivalents at end of period** | 258,756 | 171,029 |