Metabolic dysfunction-associated steatotic liver disease

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), April 5, 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 filing of its 2023 Universal Registration Document with the Autorité des marchés financiers (AMF ; filing n° D.24-0246) and its Annual Report on Form 20-F for the year ended December 31, 2023 with the U.S. Securities and Exchange Commission (SEC). These annual reports are available to the public free of charge in accordance with applicable regulations and may be viewed at and downloaded from GENFIT’s website at ir.genfit.com. The 2023 Registration Document will also be available shortly on the AMF’s website: www.amf-france.org and the Annual Report on Form 20-F is available on the website of the SEC (www.sec.gov). GENFIT’s 2023 Universal Registration Document includes, in particular: the annual financial report, the annual management report, the Board of Directors’ report on corporate governance,the Statutory Auditors’ reports on the annual and consolidated financial statements and related-party agreements, andthe table summarizing the fees paid to the Statutory Auditors. 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 spanning more than two decades. Today, GENFIT has a growing and diversified pipeline with programs at various development stages. The Company’s area of focus is Acute on Chronic Liver Failure (ACLF). Its ACLF franchise consists of five assets in development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE. These are all based on differentiated mechanisms of action leveraging complementary pathways. Other assets target other life-threatening disease indications such as cholangiocarcinoma (CCA) and Urea Cycle Disorders (UCD)/Organic Acidemias (OA). GENFIT’s track record in bringing early-stage assets with high potential to late development and pre-commercialization stages is highlighted in the successful 52-week Phase 3 ELATIVE® trial evaluating elafibranor in PBC. Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic franchise focused on Metabolic dysfunction-associated steatohepatitis (MASH) previously known as nonalcoholic steatohepatitis (NASH) and ammonia. GENFIT has facilities in Lille and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital. For more information, visit www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe”, “potential,” “expect”, “target”, “may”, “will”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, potential commercial success of elafibranor if approved, exchange rate fluctuations, our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Main Risks and Uncertainties” of the Company’s 2023 Universal Registration Document (n° D.24-0246) filed with the AMF on April 5, 2023, which is available on the Company’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”) including the Company’s 2023 Annual Report on Form 20-F filed with the SEC on April 5, 2023. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACT GENFIT | Investors Tel: +33 3 2016 4000 | investors@genfit.com PRESS RELATIONS | Media Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com Attachment GENFIT Announces Publication of the 2023 Universal Registration Document and the 2023 Annual Report on Form 20-F

The delay for an injectable version of Leqembi, an expanded CAR-T manufacturing deal for Carvykti and the first Ozempic biosimilar filing in China made our news this week. Eisai and Biogen's subcutaneous Leqembi faces a regulatory delay. Johnson & Johnson and Legend Biotech have expanded their contract manufacturing deal with Novartis around Carvykti. A Chinese drugmaker is seeking local approval of a biosimilar version of Novo Nordisk's Ozempic. And more. 1. Eisai, Biogen's injectable Leqembi delayed as FDA asks for more data The FDA is asking for more data on an injectable version of Eisai and Biogen’s Leqembi. The demand has caused the delay in the formulation’s filing, because Eisai can’t start a rolling submission without first gaining a “fast track” designation. Analysts have hoped that a more convenient injection could help accelerated uptake of the currently infused Alzheimer’s disease drug. 2. J&J, Legend expand manufacturing deal with Novartis to include commercial production of Carvykti Legend Biotech and Johnson & Johnson have expanded a contract manufacturing deal with Novartis to now include both clinical and commercial manufacturing of the pair’s CAR-T therapy Carvykti. The new deal runs through the end of 2029 and will see Novartis produce Carvykti at its Morris Plains plant in New Jersey. The new pact comes as Carvykti looks on track to enter earlier treatment of multiple myeloma. 3. First biosimilar to Novo’s Ozempic seeks approval in China (Reuters) A Chinese drugmaker, Jiuyuan Gene Engineering of Hangzhou, said it has sought local approval of a biosimilar version of Novo Nordisk’s diabetes drug Ozempic. The company names the drug Jiyoutai and noted that it was the first to file an application for a copycat of semaglutide, the active ingredient of Ozempic. According to Novo’s annual report, its Ozempic patents in China are set to expire in 2026. 4. Otsuka, Click Therapeutics snag FDA clearance for depression therapy app Otsuka and Click Therapeutics have secured FDA clearance for the first prescription digital therapeutic for major depressive disorder. The six-week digital program, called Rejoyn, is used alongside antidepressant drugs. The treatment provides cognitive emotional training exercises and therapeutic lessons. A 13-week randomized study showed that Rejoyn was better than a sham app at improving depression symptoms. 5. Ascletis pulls FXR agonist from pipeline over phase 2 primary biliary cholangitis data Chinese biotech Ascletis has reduced its development programs for the FXR agonist ASC42 after phase 2 data indicated the drug “did not show competitiveness” to other candidates in primary biliary cholangitis. As a result, the company has decided not to pursue further development of the drug for hepatitis B virus or as part of a combo treatment for metabolic-associated steatohepatitis. Other News of Note: 6. Aurobindo's Eugia recalls one lot of muscle relaxant because of possible contamination 7. Hutchmed, Innovent’s drug combo targets China approval in endometrial cancer (release)

TEL AVIV, Israel, April 4, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2023, with the U.S. Securities and Exchange Commission (the "SEC"). The report is available on the SEC's website, at and Galmed's Investor Relations website, at . Shareholders can obtain copies of Galmed's Annual Report on Form 20-F, free of charge, by making a request within a reasonable period of time to Galmed's Investor Relations Department at [email protected]. Galmed Pharmaceuticals Ltd. We are a clinical stage biopharmaceutical company focused on the development of Aramchol for liver and fibro-inflammatory diseases. We have focused almost exclusively on developing Aramchol for the treatment of NASH and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide. Forward-Looking Statements: Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believesor anticipate will or may occur in the future. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, our ability to pursue, evaluate and complete any strategic alternative that yields value for our shareholders; the timing and cost of our planned Primary Sclerosing Cholangitis, or PSC, clinical trial and our pivotal Phase 3 ARMOR trial, or the ARMOR Study, if re-initiated, for our product candidates, Aramchol and Amilo-5MER, or for any other pre-clinical or clinical trials; completion and receiving favorable results of our planned PSC clinical trial and the ARMOR Study (if re-initiated) for Aramchol or any other pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or FDA, the European Medicines Authority, or EMA, or the Medicines and Healthcare Products Regulatory Agency, or the MHRA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, Amilo-5MER or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, Amilo-5MER or any other product candidate; our expectations regarding the commercial market for PSC, non-alcoholic steato-hepatitis, or NASH (also known as MASH), in patients or any other targeted indication; third-party payor reimbursement for Aramchol, Amilo-5MER or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; the development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; security, political and economic instability in the Middle East that could harm our business, including due to the recent attacks by Hamas and other terrorist organizations from the Gaza Strip and elsewhere in the region and Israel's war against them and military hostilities with Hezbollah on the northern border of Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 4, 2024 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. Logo - SOURCE Galmed Pharmaceuticals Ltd.