* ELATIVE(®) Phase III trial confirms potential for investigational

    elafibranor as a novel, first-in-class, dual PPAR ?,? agonist for patients
    with primary biliary cholangitis.
  * Elafibranor demonstrates significant improvements in biomarkers of disease
    progression versus placebo, including significant treatment benefit with
    improvement in biochemical response and alkaline phosphatase (ALP)
    normalization, along with patient-reported outcomes data suggesting a
    possible improvement in pruritus.
  * Elafibranor was generally well-tolerated with a well-documented safety
    profile consistent with previous trials.

PARIS, FRANCE, 13 November, 2023 - Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced full results from the pivotal Phase III ELATIVE(®) trial, which are being presented in a late-breaking oral session (Abstract #484, Monday, 13 November at 16.45 EST) at the American Association for the Study of Liver Disease (AASLD) and simultaneously published in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2306185) (NEJM). This trial evaluated the efficacy and safety of investigational elafibranor, an oral, dual PPAR ?,? agonist, as a potential novel class of treatment for patients with the rare, autoimmune cholestatic liver disease, primary biliary cholangitis (PBC).
Results show statistically significant improvements in biomarkers of disease progression across key endpoints with a significant treatment benefit achieved in the primary composite endpoint, demonstrating a 47% placebo-adjusted difference (P= 15 percent and total bilirubin (TB) 10% of patients and
more frequently on elafibranor versus placebo included abdominal pain, diarrhea,
nausea, and vomiting. Elafibranor has a well-documented safety profile across a broad patient population and is consistent with cumulative safety data from past
elafibranor trials in other indications, including NASH.
Data from ELATIVE are being used to support submissions for elafibranor as a treatment for PBC with regulatory authorities worldwide.
ENDS
ELATIVE
ELATIVE is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial, with an open-label long-term extension (NCT04526665). ELATIVE is evaluating the efficacy and safety of elafibranor 80mg once daily versus placebo for the treatment of patients with PBC with an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. The trial enrolled 161 patients who were randomized 2:1 to receive elafibranor 80mg once daily or placebo. Patients with an inadequate response to UDCA would continue to receive UDCA in combination with elafibranor or placebo, while patients unable to tolerate UDCA would receive only elafibranor or placebo.
Elafibranor
Elafibranor is a novel, oral, once-daily, dual peroxisome activated receptor (PPAR) alpha/delta (?,?) agonist, currently under investigation as a treatment for patients with PBC, a rare liver disease. Concurrent ?,? activation targets inflammation, cholestasis and fibrosis in PBC. In 2019, elafibranor was granted a Breakthrough Therapy Designation by the FDA in adults with PBC who have an inadequate response to UDCA. Elafibranor has not received approval by regulatory
authorities anywhere in the world.
Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative
medicines in Oncology, Rare Disease and Neuroscience. With total sales of EUR3.0bn
in FY 2022, Ipsen sells medicines in over 100 countries. Alongside its external-
innovation strategy, the Company's research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,300
colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com (https://www.ipsen.com)
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 MASH (previously known as 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
For further information:
Ipsen Contacts
Investors
Craig Marks Nicolas Bogler
Vice President, Investor Relations

 +44 (0)7584 349 193                                 Investor Relations Manager
                                                     +33 6 52 19 98 92

Media

 Anna Gibbins                                        Ioana Piscociu
 Global Head of Franchise Communications,            Senior Manager
 Rare Disease                                        Global Media Relations
 +44 (0)7717801900                                   +33 6 69 09 12 96

Amy Wolf
VP, Head of Corporate Brand Strategy &
Communications
+41 79 576 07 23
GENFIT contacts
GENFIT | Investors Tel: +33 3 2016 4000 | investors@genfit.com (mailto:investors@genfit.com)
PRESS RELATIONS | Media Stephanie Boyer - Press relations | Tel:
+33 3 2016 4000 | stephanie.boyer@genfit.com
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to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's latest Universal Registration Document, available on ipsen.com (https://www.ipsen.com).
GENFIT's 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 with respect to GENFIT, including, but not limited to statements about the potential of elafibranor as a safe and effective second-line treatment for PBC, the opportunity to manage the disease progression and the potential of elafibranor to improve pruritus, reduce cholestatic injury and improve liver function. The use of certain words, including "believe", "potential," "expect", "target", "may" and "will" 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 2022 Universal Registration Document filed with the AMF on April 18, 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 2022 Annual Report on Form 20-F filed with the SEC on April 18, 2023
and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2023 or otherwise made public, by the Company. 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.
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