GENFIT : 2021 GENFIT Half Year Business and Financial Report

HALF-YEAR

BUSINESS

AND FINANCIAL

REPORT

AT JUNE 30, 2021

CONTENTS

Half-Year Business and Financial Report at June 30, 2021

Half-Year Condensed Consolidated Financial Statements at June 30, 2021

Statutory Auditors' Limited Review Report on 2021 Half-Year Condensed Consolidated Financial Statements

pages 1-22

pages 23-76

pages 77-80

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HALF-YEAR BUSINESS AND FINANCIAL REPORT AS OF JUNE 30, 2021

This report 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 GENFIT's corporate strategy and objectives, the potential sizes of the markets for PBC, PSC and ACLF, commercial certainty within these markets and the outcome of the ELATIVE™ phase 3 trial of elafibranor in PBC, timelines for completion of the ELATIVE™ trial and receipt of market authorization if the result is positive, timelines for and success of the commercial deployment of the diagnostic test powered by NIS4® developed by GENFIT's partner LabCorp and the size of the market for which it is designed, the ability of the NIS4® technology to facilitate the development of an IVD test approvable by the regulatory authorities, and our ability to significantly reduce our projected cash burn over the next several years. The use of certain words, including "believe," "potential," "expect" 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 related to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates, the impact of the COVID-19 pandemic, fluctuations in exchange rates, and the Company's continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company's public filings with the French Autorité des marchés financiers ("AMF"), including those listed in Section 2 "Risks Factors and Internal Control " of the Company's 2020 Registration Document ("Document d'Enregistrement Universel") filed with the AMF on April 23, 2021, which is available on GENFIT'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 Form 20-F document filed with the SEC on the same date, and subsequent filings and reports filed with the AMF or SEC, 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.

1. OVERVIEW OF THE GROUP AND ITS MAIN R&D PROGRAMS 1.1 Overview

GENFIT is a late-stage biopharmaceutical group ("the Group" or "GENFIT" or "the Company"), comprised of the parent company GENFIT SA and its two wholly owned subsidiaries (GENFIT CORP and GENFIT PHARMACEUTICALS) dedicated to improving the lives of patients with cholestatic and chronic metabolic liver diseases for which there is a significant medical need, and conducting late stage clinical trials.

Thanks to a rich history and strong scientific heritage spanning more than two decades, GENFIT became a pioneer in the field of nuclear receptor-based drug discovery. The Company is also developing a new diagnostic technologies.

We develop these therapeutic and diagnostic solutions to eventually make them available to patients. With this goal in mind, we have developed multiple technical platforms in our areas of therapeutic expertise, and set up close collaborations with academic experts and specialized companies whose expertise complements our own.

HALF-YEAR BUSINESS AND FINANCIAL REPORT AT JUNE 30, 2021

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Our Research and Development ("R&D") is founded on several areas of excellence:

• Clinical expertise in our major therapeutic areas, with detailed knowledge of the diseases
• An in-depth scientific understanding of gene regulation and of biological mechanisms in our therapeutic areas of interest,
• A broad technological know-how to study and control biological mechanisms, with a focus on translational research between human and animal models.

In addition, we possess the necessary expertise and experience to coordinate and manage regulatory preclinical toxicology, pharmacokinetic, and ADME (Absorption, Distribution, Metabolism, and Excretion) studies as well as to manage the development and production of active pharmaceutical ingredients and drug products, throughout the entire drug development process.

Our current Chairman of the Board of Directors, Jean-François Mouney, co-founded GENFIT SA in 1999. Pascal Prigent, our current CEO, was appointed in September 2019.

We are led by an executive team and board of directors with deep experience at leading biotech companies and consulting firms, large pharmaceutical companies and academic institutions.

The chairman of our scientific advisory board, Professor Bart Staels, is a co-founder of our Company and a world- renowned expert in nuclear receptors. Our scientific advisory board is comprised of internationally recognized key opinion leaders in the field of metabolic and inflammatory diseases, with a particular focus on the liver and gastroenterology.

As of June 30, 2021, the Group has approximately 122 employees at our offices in Lille and Paris, France and Cambridge, Massachusetts, USA.

Genfit's shares are listed on the regulated market of Euronext in Paris (compartment B - ISIN: FR0004163111) and, since March 2019, as American Depositary Shares ("ADSs"), each representing one ordinary share, on the Nasdaq Global Select Market in the United States, under the common symbol "GNFT".

1.2 Main R&D Programs of the Company

1.2.1. Phase 3 clinical development program in « PBC »

We are evaluating elafibranor - our most advanced drug candidate - as a potential treatment for Primary Biliary Cholangitis ("PBC") in an international Phase 3 trial ("ELATIVE™").

PBC is an autoimmune, chronic disease resulting from progressive destruction of the small bile ducts inside the liver. When liver bile ducts are destroyed, the bile which normally would travel to the small intestines to aid in digestion and elimination of waste instead accumulates in the liver, contributing to inflammation and fibrosis. Contrary to non-alcoholic steatohepatitis ("NASH"), for which elafibranor has already been unsuccessfully evaluated, PBC is a metabolic disease and its progression is therefore not affected by dietary hygiene as NASH can be.

The initial symptoms of PBC are general fatigue and pruritus, which is itchy skin. Left untreated, PBC typically leads to cirrhosis, liver failure and the need for liver transplantation.

HALF-YEAR BUSINESS AND FINANCIAL REPORT AT JUNE 30, 2021

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• Prevalence, therapeutic options and current medical needs

PBC is a disease with a global prevalence of approximately 40 cases per 100,000. However, that prevalence is increasing; in the United States, the prevalence of PBC increased from 21.7 to 39.2 per 100,000 from 2006 through 2014.

There is currently no cure for PBC, although there are medications that work to slow its progression. For many years, ursodiol, a drug containing ursodeoxycholic acid, or UDCA, was the only drug approved by the FDA for the treatment of PBC. Although ursodiol is the first line treatment, up to 40% of patients do not respond or respond poorly to treatment and an additional 5-10% of patients are unable to tolerate the drug.

In 2016, the FDA approved obeticholic acid, marketed as Ocaliva®, for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA. Concerns remain over pruritus and also serious liver injury or liver death caused by administration of Ocaliva®, which led the FDA to add a Boxed Warning to the Ocaliva® label. Moreover, Intercept Pharmaceuticals indicated that discussions took place with the FDA in early 2021, regarding the post-marketing discovery of a NISS (Newly Identified Safety Signal) for Ocaliva® during a routine FDA inspection regarding patients with cirrhosis.

Accordingly, we believe there is still a significant medical need for new therapies. This conclusion is in fact echoed by an IQVIA study conducted among a large number of physicians who believe that the current treatments turn out to be ineffective for a large number of PBC patients, or that they cause side effects that are too significant, or present safety risks.

• Elafibranor in PBC: from a successful phase 2 to the ongoing ELATIVETM phase 3

Positive results from our Phase 2 clinical trial of elafibranor in PBC, presented in April 2019 at the International Liver Congress 2019 organized by EASL (European Association for the Study of the Liver) and published in February 2021 in the Journal of Hepatology formed a strong rationale to launch the Phase 3 ELATIVE™ trial for the evaluation of elafibranor in this indication. Elafibranor met the primary endpoint of our Phase 2 clinical trial, which was the relative change from baseline at week 12 in serum alkaline phosphatase (or "ALP"). Compared to placebo, treatment with 80 mg and 120 mg elafibranor resulted in mean decrease from baseline of -52% and -44%, respectively, each with high statistical significance. With respect to the composite endpoint used for registration of Ocaliva®, elafibranor achieved significantly higher response rates as compared to the placebo.

ELATIVE™ is an international Phase 3 double-blind randomized placebo-controlled study, for which the first patient first visit occurred on September 24, 2020. The primary endpoint to evaluate the response to treatment at week 52 is the composite endpoint used for Ocaliva® that led to its market approval as a second line treatment in PBC. Secondary endpoints include response to treatment based on ALP normalization at week 52 and change in pruritus from baseline through week 52 on PBC Worst Itch NRS score.

With respect to the estimated clinical timelines, we expect enrolment of the phase 3 cohort to be completed during the first quarter of 2022. As a result, we would expect to announce top-line data between the end of the first quarter and the middle of the second quarter of 2023. On this basis, a new drug application (NDA) could then be filed with the FDA during the second half of 2023, subject to a successful trial outcome. Based on these projections, we are targeting a potential approval of elafibranor in PBC in the United States in the second half of 2024.

Genfit owns all development and commercialization rights for elafibranor in this indication, with the exception of Greater China, for which they were granted to Terns Pharmaceuticals ("Terns"), as part of a collaboration and licensing agreement signed in June 2019.

HALF-YEAR BUSINESS AND FINANCIAL REPORT AT JUNE 30, 2021

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1.2.2. R&D efforts refocused on two specific therapeutic areas: "ACLF" and "cholestatic diseases"

During the first half of 2021, we decided to refocus our R&D efforts on two therapeutic areas with significant unmet medical needs: ACLF and cholestatic diseases. This decision was communicated in a detailed presentation to the shareholders, which is available on the Company website: https://78449.themediaframe.com/dataconf/productusers/genfit/mediaframe/44861/indexl.html

• ACLF

Acute on Chronic Liver Failure (ACLF), a syndrome in patients with chronic liver disease and cirrhosis characterized by acute hepatic decompensation resulting in liver failure and/or one or more extrahepatic organ failures, is associated with increased risk for short-term mortality. There are no approved drugs to treat patients and therefore a need exists for a therapy that helps them to survive without transplantation.

GENFIT has launched a clinical program with nitazoxanide (NTZ) in this disease, based on its antibiotic and anti- inflammatory activity1. A Phase 1 study to evaluate pharmacokinetics and pharmacodynamics of NTZ in patients with varying degrees of hepatic impairment is expected to start before the end of the year.

We are also initiating a number of preclinical undertakings to explore the potential of other proprietary drug candidates such as elafibranor and GFT1575 in ACLF.

• Cholestatic diseases

Chronic cholestatic diseases are characterized by defective bile acid transport from the liver to the intestine, which is caused by primary damage to the biliary epithelium in most cases.

GENFIT is already present in this therapeutic area with ELATIVE™, its Phase 3 clinical trial evaluating the potential of elafibranor in Primary Biliary Cholangitis (PBC) and the Company plans to initiate an exploratory study, complementary to the ELATIVE™ study, to evaluate the potential benefit of elafibranor in treatment naïve patients with PBC, which should start before the end of the year.

Moreover, in the fourth quarter of 2021, GENFIT also plans to launch a Phase 2 proof of concept study to evaluate elafibranor in Primary Sclerosing Cholangitis - another cholestatic disease - (PSC).

PSC is a disease characterized by an inflammatory and fibrotic affection of the intra- and/or extra-hepatic biliary tract. The evolution of the disease is characterized by a narrowing of the bile ducts (stenosis) which impedes the bile flow (cholestasis). Its evolution is variable and progressive, and prolonged cholestatis may lead to liver cirrhosis and severe complications that may require a liver transplant. PSC is also often linked to an inflammatory disease affecting the colon, such as ulcerative colitis.

Unlike PBC, PSC is more frequent in men and may also be found in children. Its prevalence is estimated between 8 and 14 cases per 100,000 individuals according to the result of two studies conducted in Norway and the United States among Caucasian subjects. As such, it is commonly considered an orphan disease three times less prevalent than PBC.

UCDA is the only therapeutic option for patients, but its relevance is subject to debate, and liver transplant is the only therapeutic option for patients in the final stage of their hepatopathy.

We estimate that these three new studies (phase 1 evaluating pharmacokinetics and pharmacodynamics of NTZ in patients with varying degrees of hepatic impairment, exploratory study to evaluate the potential benefit of

1 NTZ is currently marketed and prescribed in the United States and several other countries as antiparasitic treatment, and we believe it can be repositioned for the treatment of ACLF.

HALF-YEAR BUSINESS AND FINANCIAL REPORT AT JUNE 30, 2021