ASK1

US Food and Drug Administration (FDA) has granted Priority Review for New Drug Application (NDA) for elafibranor in PBC, and European Medicine Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor. Acceptance triggers a first milestone payment. Further milestones are expected upon US and European launches which could now happen in 2Q24 in the US (FDA PDUFA1 action date: June 10, 2024) and 2H24 in Europe. These milestones total approximately 89M€. Launches in the US and Europe will also make GENFIT eligible for royalty payments. Revenues will fund the development of GENFIT’s pipeline, now mainly focused on Acute On-Chronic Liver Failure (ACLF) with 5 differentiated assets. Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), December 8, 2023 – 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 announces its revised outlook for 2024 and reflects on recent progress. Elafibranor in PBC Ipsen has made significant progress since the announcement of positive interim data of ELATIVE® pivotal Phase 3 trial in June 2023: Strong leadership presence at AASLD The Liver Meeting® and additional results from ELATIVE® presented as late breaker, including data showing statistically significant improvement (nominal p-value < 0.05) on multidimensional measures of pruritus (PBC-40 and 5D-itch scores)Publication of ELATIVE® Phase 3 data in the New England Journal of MedicineRegulatory filing acceptance obtained in the US, Europe and United Kingdom2 in less than 6 months after topline Phase 3 data, and Priority Review granted for NDA by the US FDA with PDUFA target action date on June 10, 2024 During its Capital Market Day on December 7, Ipsen reiterated its confidence in elafibranor as its profile could be very beneficial for patients suffering from PBC. In the ELATIVE® Phase 3 trial, significant treatment benefit in the primary composite endpoint was achieved with elafibranor, with a high responder rate, and a low placebo effect3. The key secondary endpoint on ALP normalization was achieved – despite a high baseline ALP level – with high statistical significance, the pruritus improvements on PBC-40 and 5D-itch scores were also statistically significant4 and elafibranor was generally well-tolerated with a well-documented safety profile consistent with previous trials. Acceptance of filings in the US and Europe have triggered the first milestone payment for GENFIT. We also expect additional milestones after US and European launches and as a result should receive a total of approximately 89M€ by the end of next year. Ipsen also indicated that they were expecting global peak sales to exceed 500M€ for elafibranor in PBC. With eligibility for tiered double-digit royalties under the agreement with Ipsen, this could mean a very significant revenue stream for GENFIT based on these royalties and additional milestone payments. Ipsen also indicated that it is developing elafibranor in Primary Sclerosing Cholangitis (PSC) which could lead to further revenues for GENFIT under the licensing agreement. Pascal Prigent, CEO of GENFIT, commented: “We continue to be pleased by Ipsen’s commitment and results already obtained. We believe that their excellent and proven launch capabilities will allow them, once approved, to quickly bring elafibranor to the many patients that need it. I have no doubt that they will maximize the potential of elafibranor, and this will obviously be very beneficial for GENFIT as it will help us accelerate the development of our deep and promising pipeline.” Pipeline outlook for 2024 GENFIT’s R&D efforts have pivoted from chronic to acute liver diseases, with a strong focus on ACLF where the unmet medical need is very important, with currently no approved therapies. Our therapeutic candidates have been strategically selected based on the pathophysiology of ACLF to address the most relevant pathways via differentiated and complementary modes of action. In 2024, progress is expected to be made on all programs of the ACLF franchise: VS-01 (liposomal-based technology designed to remove ammonia and other ACLF toxins from the blood): Phase 2 initiated with interim data readout targeted for mid-2024 NTZ (anti-inflammatory and anti-bacterial agent aiming to reduce systemic inflammation, and impede release of PAMPs5 and bacterial translocation): reformulation and Phase 2 under preparation in 2024 with a proof-of-concept study initiation targeted for 1H25SRT-015 (ASK1 inhibitor, liver-centric, aimed at inhibiting cell death, inflammation and fibrosis): first-in-Human study initiation targeted 2H24CLM-022 (NLRP3 inflammasome inhibitor aimed at inhibiting systemic inflammation and cell death): preclinical Proof of Concept expected to initiate in 2024VS-02-HE (small molecule aiming at reducing hyperammonemia, stabilizing blood ammonia and preventing hepatic encephalopathy): IND enabling studies starting in 2024 with completion expected in 2025 GENFIT also develops assets in other rare and life-threatening liver diseases with high unmet medical needs: GNS561 for cholangiocarcinoma (CCA): Phase 1b interim biomarker data targeted as early as 1H24VS-01 for Urea Cycle Disorders (UCDs) and Organic Acidemias (OA): IND enabling non clinical studies completion expected in 2024 ABOUT ELAFIBRANOR Elafibranor is an oral, once-daily, dual peroxisome activated receptor (PPAR) alpha/delta (α,δ) agonist, currently under investigation as a treatment for patients with PBC, a rare cholestatic liver disease. Elafibranor, through activation of PPAR α,δ targets multiple cell types and biological processes involved in the pathophysiology of PBC, including cholestasis (impairment of bile flow in the liver), bile toxicity, inflammation and fibrosis and bile acid output. In 2019, elafibranor was granted a Breakthrough Therapy Designation by the U.S Food and Drug Administration in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA) the existing first-line therapy for PBC. Elafibranor has not received approval by regulatory authorities anywhere in the world. ABOUT ELATIVE® ELATIVE is a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial, with an open-label long-term extension (NCT04526665). ELATIVE evaluated 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 UDCA. The trial enrolled 161 patients who were randomized 2:1 to receive either 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. Data confirmed the potential for elafibranor to be an effective new treatment option for PBC, with 13 times more patients achieving a biochemical response, suggesting an improvement in disease progression, when treated with elafibranor compared with patients on placebo: 47% placebo-adjusted difference, elafibranor 80mg (51%) compared with placebo (4%) (P<0.001). ABOUT ACLF ACLF presents as a syndrome defined by a combination of hepatic and extrahepatic organ dysfunctions and failures and a uniformly poor prognosis. In patients with liver cirrhosis and acute hepatic decompensation, ACLF can be triggered by a precipitating event (e.g., an infection) that leads to a progressive functional deterioration of multiple organs with high short-term mortality (23% to 74% mortality at 28 days)6. ACLF represents a significant cost of care for healthcare systems, as it is characterized by an abrupt life-threatening worsening of a preexisting advanced chronic liver disease resulting in acute liver decompensation, liver failure and extrahepatic organ failure. With a $52k average cost per hospitalization per patient in the US and a 16-day average length of hospital stay, estimated annual cost burden in the US was $6.4bn in 2021, a nearly 4-fold increase since 20117. 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 with respect to GENFIT, including, but not limited to statements about the potential of elafibranor to receive marketing authorization in the United States, Europe and United Kingdom for PBC, expected milestone and royalty payments for elafibranor in PBC, Ipsen’s expectations regarding global peak sales for elafibranor in PBC, Ipsen’s ability to effectively maximize commercialization of elafibranor and the ability of GENFIT to receive revenues related to development and future commercialization of elafibranor in PSC. 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. 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 1 Prescription Drug User Fee Act2 https://ir.genfit.com/news-releases/news-release-details/ipsen-confirms-us-fda-grants-priority-review-new-drug3 a 47% placebo-adjusted difference (P<0.001) between patients on elafibranor 80mg (51%) compared with patients on placebo (4%) achieving a biochemical response4 nominal p-value < 0.055 pathogen-associated molecular pattern molecules6 Arroyo V et al., Nat. Rev. Dis. Primers 2 (2016)7 IQVIA presentation GENFIT’s ACLF Day Nov 2023 GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com Attachment 2023.12.08 - PR EN - GENFIT - 2024 outlook - FINAL

GENFIT highlighted new focus and development strategy in Acute On-Chronic Liver Failure (ACLF)ACLF is a very serious condition affecting ~294,0001 2 patients with chronic liver diseases in the USA and Europe every year and is associated with multi-organ failure and high short-term mortalityIt is an underserved medical condition with currently no approved treatment and few programs under development globallyGENFIT has developed a unique pipeline of 5 different drug candidates targeting key pathophysiological pathways of ACLF Phase 2 interim data readout from lead program VS-01 in ACLF targeted for 2Q24 Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 16, 2023 – 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 highlights from its “ACLF Day” held on November 11, 2023 during AASLD The Liver Meeting ® in Boston, MA (USA). GENFIT is now mainly focused on the development of therapies for ACLF which is an area of very high unmet medical need. ACLF is a potentially deadly, but reversible, condition in patients with chronic liver diseases, which is associated with multi-organ failure and high short-term mortality. There is currently no approved treatment for ACLF. The presentation from the event is available on the company website in the investors section. The development of the company’s new, expanded and diversified pipeline targeting rare and life-threatening liver diseases with high unmet medical needs will be supported by potential milestone payments and royalties deriving from the licensing of elafibranor3 to its partner, Ipsen. At AASLD, Ipsen presented additional data from the ELATIVE® Phase 3 study in primary biliary cholangitis (PBC) and announced its publication in the prestigious New England Journal of Medicine (November 2023)4. Data from ELATIVE® are being used to support Ipsen's submissions for elafibranor as a treatment for PBC with regulatory authorities in the US and EU5. Pascal Prigent, CEO of GENFIT, commented: “During AASLD we were excited to further discuss our development strategy around our new pipeline focused on ACLF, where we believe multiple programs have the potential to transform the treatment paradigm for these patients. It was also great to see more data presented by our partner Ipsen on PBC, which confirm that elafibranor has a competitive profile and a great potential to help patients with this disease. This AASLD meeting reinforced our conviction that Ipsen, as it works through the approval process with regulatory authorities in the US and EU, is committed to getting elafibranor to patients as quickly and efficiently as possible. For GENFIT this could mean significant revenues that will fund the development of a truly unique portfolio aiming at providing solutions for healthcare professionals treating patients suffering from a very challenging condition for which there is currently no approved options. We look forward to presenting preliminary data from our lead ACLF program, VS-01, as early as next year.” ACLF: high short-term mortality, no approved treatment ACLF is a serious, but potentially reversible, condition in patients with chronic liver disease and cirrhosis, which is associated with multiple organ failure, and a 23% to 74% mortality at 28 days6 depending on grade severity. As part of the “ACLF Day” event during AASLD, the critical need for treatment has been highlighted by leading experts in ACLF. Dr Jennifer C. Lai, MD, MBA, Transplant Hepatologist, Endowed Professor of Liver Health & Transplantation, University of California, San Francisco (UCSF) said: “ACLF is a terrifying condition for patients and their caregivers, but it’s equally terrifying for clinicians, because we know our patients are in grave and immediate danger, and we have no approved treatment to help them. It is very frustrating and therefore it is critical that therapies are developed, ideally to reverse the course of the disease or at least to give the patient more time to get a potentially life-saving transplantation. This is an area of huge unmet medical need and I welcome new efforts to develop potentially helpful therapies.” GENFIT’s pipeline in ACLF: targeted to address the unmet need GENFIT’s ACLF therapeutic candidates have been strategically selected based on the pathophysiology of ACLF – as defined by liver experts and consortiums such as EF-CLIF (European Foundation for the study of Chronic Liver Failure) – to address the most relevant pathways. Considerations about the limitations in current standard of care have also been taken into account. Among the pathways identified, priority is given to systemic inflammation, cell death and microbiota. Dean Hum, PhD, Chief Scientific Officer of GENFIT, commented: “Our R&D strategy is centered on understanding the pathophysiology of ACLF and selecting molecules that we believe are best positioned to impact specific relevant pathways. This multi-factorial approach will allow us greater chances of success as well as leveraging potential synergies via combinations. It also offers the possibility to apply key learnings across all ACLF programs, to accelerate overall execution.” The ACLF pipeline overview: VS-01 – Phase 2 initiated (interim data readout targeted for the end of 2Q24): VS-01 is a liposomal-based technology designed to remove ammonia and other ACLF toxins from the blood (peritoneal route of administration) NTZ – Reformulation and Phase 2 under preparation (proof-of-concept study initiation targeted for the first half of 2025): NTZ is an anti-inflammatory and anti-bacterial agent aiming to reduce systemic inflammation, and impede release of PAMPs7 and bacterial translocation (oral route of administration)SRT-015 – First-in-Human study under preparation (expected to be initiated 2H24): SRT-015 is an ASK1 inhibitor, liver-centric, aimed at inhibiting cell death, inflammation and fibrosis (injectable route of administration)CLM-022 – Preclinical proof of concept under preparation (expected to start 2024): CLM-022 is an NLRP3 inflammasome inhibitor aimed at inhibiting systemic inflammation and cell death (pyroptosis)VS-02-HE – Completion of IND enabling studies expected in 2025: VS-02-HE aims at reducing hyperammonemia, stabilizing blood ammonia and preventing hepatic encephalopathy (oral route of administration) Inaugural Patient Advocacy Council organized by GENFIT Patients are at the heart of what GENFIT does. As we embark on a major new R&D initiative, it was important to integrate the patient voice very early in the process. This is why we hosted two Patient Advocacy Council sessions at AASLD. GENFIT’s ambition is to co-design initiatives with patient representatives and leading clinicians in order to better understand patients’ and caregivers’ information needs, gather their insights and perspective in the context of clinical trial design, and facilitate access to innovative medicine through clinical trials. 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 with respect to GENFIT, including, but not limited to statements about expectations for availability of clinical data in the evaluation of VS-01 in ACLF, Ipsen’s ability to obtain quickly and efficiently, marketing authorization for elafibranor in PBC, GENFIT’s ability to receive milestones and royalties under the collaboration and licensing agreement with Ipsen with respect to PBC and the use of those potential revenues to fund GENFIT’s further R&D and start dates of clinical and pre-clinical development phases for GENFIT’s other pipeline programs. 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. 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 1 Source: Moreau, R., et al., (2013) Supplemental Table 10)2 Therapies targeting ACLF are eligible for Orphan Drug Designation given low prevalence and lack of therapies3 Elafibranor’s rights have been licensed to Ipsen in December 2021 and to Terns Pharmaceuticals in June 2019 for China, Hong Kong and Macau 4 https://www.nejm.org/doi/full/10.1056/NEJMoa23061855 https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/08/11114914/Ipsen-investor-presentation-September-2023.pdf (slide 9)6 Arroyo V et al., Nat. Rev. Dis. Primers 2 (2016)7 Pathogen-associated molecular patterns Attachment GENFIT Highlights ACLF Development Strategy at “ACLF Day” during AASLD The Liver Meeting® 2023

Cash, cash equivalents and current financial assets totaled €111.8 million as of June 30, 2023 Positive results in the pivotal Phase 3 ELATIVE® trial in June 2023, paving the way to: a potential submission to the health authorities by Ipsen, and a potential first milestone met before the end of 2023, and if approved, commercialization would trigger further milestone payments and royalty payments GENFIT’s leadership in ACLF is further strengthened, with now 5 complementary assets in development, ranging from preclinical candidates to Phase 2 clinical stage programs Conference call in English on September 20, 2023 at 4.15pm ET / 9.15pm GMT / 10.15pm CET Lille (France), Cambridge (Massachusetts, United States), (Zurich, Switzerland);September 20, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced its first half-year 2023 financial results and provided a corporate update. Pascal Prigent, CEO of GENFIT, commented : “The positive interim results of our ELATIVE® Phase 3 study in PBC means that GENFIT is now entering into a new era, as we pivot from a focus on a single program to the development of a robust portfolio of exciting programs. Additional ELATIVE® data will be released in the coming months, and we are confident that this data will further demonstrate that elafibranor has a very competitive pro the potential to add significant value to patients with PBC. We are pleased to see the commitment of our partner Ipsen and believe that they will make the most of the opportunity. For GENFIT, this means a potential first milestone in 2023 and, if elafibranor is approved in PBC, additional milestones and a regular revenue stream of royalty payments. These potential revenues would be used to finance the development of a very exciting pipeline of seven different programs ranging from preclinical to Phase 2. In particular we have five distinct programs in ACLF where the medical need is significant.” GENFIT will host a conference call in English on September 20, 2023 at 4.15pm EDT | 9.15pm GMT | 10.15pm CET The conference call will be accessible on the investor page of our website, under the Events section at: or by calling 888-204-4368 (toll-free United States/Canada), 0800 279 0425 (toll-free United Kingdom), 0805 101 219 (toll-free France) five minutes prior to the start time (confirmation code: 1615622). A transcript of the conference call will be made available in French on the investor page of the GENFIT website soon after the call. I. 1H23 Business highlights1 PBC: positive results from pivotal Phase 3 ELATIVE® trial GENFIT and Ipsen announced positive interim topline data from the pivotal ELATIVE® Phase 3 trial of elafibranor in PBC in the second quarter of 2023. The trial met its primary endpoint, with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to patients who received placebo. 51% of patients on elafibranor 80mg achieved a cholestasis response compared with 4% on placebo (p<0.0001). The first key secondary endpoint, normalization of ALP at Week 52, was also met with statistically significant improvements for investigational elafibranor compared with placebo. For the other key secondary endpoint, a trend for pruritus improvement was observed with a greater decrease from baseline in the PBC Worst Itch Numeric Rating Scale score for patients on elafibranor compared to placebo, which did not reach statistical significance. In the study, elafibranor was generally well tolerated with a safety pro with that observed in previously reported studies. ACLF franchise2 GENFIT’s Acute on Chronic Liver Failure (ACLF) franchise now comprises 5 assets (VS-01, NTZ, SRT-015, CLM-022, VS-02-HE) based on differentiated mechanisms of action leveraging complementary pathways. VS-01-ACLF: First patient randomized in the Phase 2 trial VS-01 is currently being evaluated in the international UNVEIL-IT™ Phase 2, open-label, randomized, controlled, multi-center, proof of concept study to assess its efficacy, safety, and tolerability in addition to standard of care (SOC), compared to SOC alone, in adult patients with ACLF grades 1 and 2 and ascites. The Investigational New Drug (IND) was in effect as of April 17, 2023, and the first patient was randomized in the Phase 2 trial in early July. The trial is expected to enroll approximately 60 adult patients with ACLF grades 1 and 2. Patients will be randomized in a 1:1 ratio to receive either daily intraperitoneal administration of VS-01 over 4 days on top of SOC (active treatment group) or SOC alone (control group). NTZ in ACLF: Phase 1 clinical data presented at DDW® Data presented in May 2023 at Digestive Disease Week® (DDW®) showed that nitazoxanide (NTZ) was generally safe and well tolerated in subjects with moderate and severe hepatic impairment. Preliminary data from a similar Phase 1 study also showed that NTZ was well tolerated with a favorable safety pro subjects with renal impairment. Following engagement with the U.S Food and Drug Administration (FDA), and on the basis of the preclinical work and phase 1 data confirming the potential of NTZ in ACLF, GENFIT has decided to pursue the development of a new nitazoxanide formulation, which will permit greater dosing flexibility. ASK1 Inhibitor SRT-015 in acute liver disease In May 2023, GENFIT licensed the exclusive worldwide rights of ASK1 Inhibitor SRT-015 (injectable formulation in acute liver disease) from Seal Rock Therapeutics, a Seattle, Washington (USA) based clinical stage company developing potential first-in-class and best-in-class kinase inhibitors. Preclinical and clinical evidence support ASK1 inhibition as a relevant therapeutic strategy in multi-system disorders such as ACLF. ASK1 inhibition has shown several potentially beneficial effects that may be relevant in ACLF, such as blocking LPS (lipopolysaccharide) associated hyperinflammatory response, reducing the ROS (Reactive Oxygen Species)-related immune response, reducing apoptosis, reducing release of the proinflammatory cytokines, reducing fibrosis, and protecting macrophage mitochondrial function. Multi-organ benefits have been observed in several animal models and clinical trials. Under the terms of the agreement, Seal Rock Therapeutics is eligible for payments of up to €100 million, including regulatory, clinical, and commercial milestone payments, plus tiered royalties. This agreement does not have any material impact on our current financial forecast, as specified in Part III of this press release. CLM-022 in liver disease treatment In July 2023, GENFIT licensed the exclusive worldwide rights of CLM-022, a potential first-in-class inflammasome inhibitor, from Celloram Inc., a Cleveland, Ohio (USA) based biotechnology company. GENFIT will leverage Celloram’s acquired scientific insights on this molecule to finalize IND enabling studies of this preclinical stage asset and secure an IND for future clinical trials. Under the terms of the agreement, Celloram is eligible for payments of up to €160 million, including regulatory, clinical and commercial milestones, as well as tiered royalties. This agreement does not have any material impact on our current financial forecast, as specified in Part III of this press release. VS-02 in HE VS-02-HE is in preclinical stages and is being developed in Hepatic Encephalopathy (HE), which is one of the major complications of advanced liver disease and portal hypertension. As many as 45% of patients with cirrhosis will experience at least one episode of HE. VS-02-HE is a urease inhibitor, designed to inhibit ureases by binding to nickel atoms in their active site. CCA CCA: Phase 1b/2a study evaluating GNS561 The first patient is expected to be screened in the second half of 2023 in a Phase 1b/2a study evaluating GNS561 in patients with KRAS mutated cholangiocarcinoma (CCA). In the Phase 1b, patients are enrolled to evaluate the safety and tolerability of GNS561 when given in combination with a MEK inhibitor, and to identify the recommended doses of the combination to be administered in the Phase 2a study. UCD and OA GENFIT is also pursuing the development of preclinical programs in Urea Cycle Disorders (UCD) and Organic Acidemias (OA). VS-01-HAC VS-01-HAC is a potential first-line lifesaving treatment for acute hyperammonemic crisis associated with Inborn Errors of Metabolism in UCD and OA. NASH diagnostic In May 2023, the Journal of Hepatology published a manuscript on the development and validation of NIS2+™, followed by an article in August 2023 on NIS2+™ ‘s performance in older patients in Hepatology Communications. At the EASL3 Congress 2023, GENFIT presented NIS2+™ as an effective screening tool for optimizing patient selection in clinical trials targeting NASH4 and as the most adapted Non-Invasive Test (NIT) for an efficient identification of at-risk NASH that is not impacted by age. Corporate governance updates At the Company’s Annual Shareholders’ Meeting held on May 24, 2023, all of the resolutions endorsed by the Board of Directors were adopted by a significant majority of the votes cast. This includes the renewal of financial authorizations that would allow the Company flexibility to seize relevant market opportunities. In June 2023, Sandra Silvestri, M.D., Ph.D., replaced Steven Hildemann M.D., Ph.D., on the Board of Directors of the Company as representative of IPSEN, the legal entity that holds the board seat. Sandra Silvestri, M.D., Ph.D., joined Ipsen in 2023 as Executive Vice President, Chief Medical Officer and Head of Global Medical Affairs, Patient Safety and Patient Affairs. In the first half of 2023, Sakina Sayah Jeanne and Tom Huijbers joined GENFIT’s Executive Committee, respectively as Executive Vice-President Research & Translational Science and Executive Vice-President Regulatory. ESG commitment GENFIT's ESG commitment and performance were recognized by independent stakeholders. In July 2023, GENFIT was awarded a gold medal by Ethifinance (compared to bronze in 2022) and ranked 2 out of 75 companies in the biopharmaceutical sector. This upgrade in the ratings is a testament to a company-wide effort in implementing CSR initiatives and ensuring transparent communications in relation to our CSR approach. In June 2023, GENFIT was classified by ODDO Research as "Best-in-Class" in its sector, based on two main criteria: activity impact and ESG maturity. In January 2023, GENFIT obtained a “Prime status” label by ISS ESG, upgrading its corporate rating from C to C+. In the second half of 2023, GENFIT will continue to reaffirm its commitment to social/societal responsibility and sustainable development. II. 2H23 and beyond: key milestones and outlook PBC Additional data on the ELATIVE® study is expected to be disclosed by Ipsen at an upcoming scientific conference. Ipsen is responsible for the development and commercialization of elafibranor, including the submission of regulatory applications for elafibranor following discussions with the FDA and the European Medicines Agency. ACLF franchise VS-01-ACLF: Interim data expected to be available in 1H24 Interim data are expected to be available in the first half of 2024 with the objective of supporting preparation of further testing of efficacy. Given the high unmet need in this indication and the Orphan Drug Designation obtained from the FDA for VS-01, it is expected that the program may qualify for some of the expedited regulatory pathways provided by health authorities. NTZ in ACLF: Phase 2 clinical trial launch expected in 1H25 Subject to the successful development of a new nitazoxanide formulation, we have revised the expected launch date of a Phase 2 clinical trial to the first half of 2025. ASK1 Inhibitor SRT-015 in acute liver disease: First-in-Human study planned in 2H24 A First-in-Human study is planned in the second half of 2024 to support a Proof-of-Concept study in ACLF patients as early as 2025. VS-02-HE IND enabling nonclinical studies are targeted to be completed in 2025. CLM-022 in liver disease treatment A preclinical proof-of-concept study is targeted for 2024. CCA GNS561 in CCA: First biomarker data targeted for 1H24 The first patient is expected to be screened in the second half of 2023. The first biomarker data are expected to be available as early as the first half of 2024 and should support preparation of further evaluation of efficacy with the optimal doses of GNS561 and a MEK inhibitor in Phase 2a of the study. Given the high unmet need in this indication and the Orphan Drug Designation obtained from the FDA for GNS561, it is expected that the program may qualify for some of the expedited regulatory pathways provided by health authorities. UCD and OA IND enabling nonclinical studies are targeted to be completed in 2024 for UCD and OA. NIS2+™ in NASH GENFIT continues to explore the possibility of obtaining regulatory approval and CE Certificates of Conformity, with a development and commercial partner, to release an IVD test powered by NIS2+™ technology on the US and European markets. In the second half of 2023, GENFIT will continue to publish data in scientific publications and at scientific events on NIS2+™. III. 1H23 Financial highlights Cash, cash equivalents and other current financial assets As of June 30, 2023, GENFIT had €111.8 million in cash, cash equivalents and other current financial assets compared with €140.2 million as of December 31, 2022. We expect that our existing cash, cash equivalents and current financial assets will enable us to fund our operating expenses and capital expenditure requirements until approximately the fourth quarter of 2024. This is based on current assumptions and without taking exceptional events into account, as well as potential milestones and royalties that the Company may receive pursuant to the licensing agreement with Ipsen. In the first half of 2023, these cash flows are mainly the result of our research and development efforts, notably for ELATIVE®, our Phase 3 clinical trial of elafibranor in PBC; UNVEIL-IT™, our Phase 2 clinical trial of VS-01 in ACLF; GNS561, as part of our cholangiocarcinoma program; and NTZ, as part of our ACLF program. Revenues and other income Revenues and other income amounted to €15.4 million in the first half of 2023 (compared with €12.2 million in the first half of 2022). Substantially, all revenue is attributable to our Collaboration and License Agreement with Ipsen and related Transition Services Agreement. Revenue growth reflects certain services billed to Ipsen under the Transition Services Agreement, originally entered into in the first half of 2022. Operating expenses Operating expenses amounted to €34.7 million in the first half of 2023 (compared with €26.5 million in the first half of 2022). Substantially, all of the increase in operating expenses is due to research and development expenses, which amounted to €25.6 million in the six months to June 30, 2023, compared with €17.6 million in the six months to June 30, 2022. Specifically, there has been an increase in: Contracting costs which amounted to €14.4 million in the first half of 2023 compared with €8.5 million in the first half of 2022, reflecting increased activities across multiple product candidates, including ELATIVE®, VS-01, GNS561 and NTZ, Employee expenses which amounted to €6.3 million in the first half of 2023 compared with €4.9 million in the first half of 2022, reflecting increased headcount, and Other expenses (maintenance, fees, travel and other taxes) which amounted to €3.3 million in the first half of 2023 compared with €2.4 million in the first half of 2022, reflecting increased activity overall, as previously noted. Financial results Financial income in the first half of 2023 was a loss of €1.1 million, compared to a gain of €4.0 million in the first half of 2022. The change in financial results is mainly due to foreign exchange gains in 2022 which did not repeat in 2023, partially offset by increased interest income in 2023 relative to 2022. Net loss The first half of 2023 resulted in a net loss of €20.9 million, compared with a net profit of €10.4 million in the first half of 2022. The table below presents the condensed Consolidated Statement of Operations under the International Financial Reporting Standards (IFRS) for the first half of 2023, with comparative figures for the first half of 2022. ' Half-year ended (in € thousands, except earnings per share data) 2022/06/30 2023/06/30 Revenues and other income Revenue 8,790 11,482 Other income 3,398 3,893 Revenues and other income 12,188 15,374 Operating expenses and other operating income (expenses) Research and development expenses (17,599) (25,630) General and administrative expenses (8,229) (9,105) Marketing and market access expenses (460) (520) Reorganization and restructuring income (expenses) 179 633 Other operating expenses (423) (52) Operating income (loss) (14,344) (19,299) Financial income 6,182 1,748 Financial expenses (2,197) (2,890) Financial profit (loss) 3,985 (1,141) Net profit (loss) before tax (10,359) (20,440) Income tax benefit (expense) (40) (414) Net profit (loss) (10,399) (20,854) Basic and diluted earnings (loss) per share Basic earnings (loss) per share (€/share) (0.21) (0.42) Diluted earnings (loss) per share (€/share) (0.21) (0.42) Further information is provided in the condensed consolidated financial statements at June 30, 2023 under the IFRS and the management discussion of the results are provided in the appendix of this press release. The condensed consolidated financial statements as well as the statutory auditors' report on those financial statements are included in the 2023 Half Year Business and Financial Report available on the “Investors” page of the GENFIT website. We encourage investors to take into consideration all the information presented in our 2022 Annual Report on Form 20-F (“Form 20-F”) filed with the U.S. Securities Exchange Commission and the 2022 Universal Registration Document filed under D.23-0304 with the French Autorité des Marchés Financiers (AMF) on April 18, 2023 and the 2023 Half-Year Business and Financial Report before deciding to invest in Company shares; these documents are available on GENFIT’s website: and on the website of the AMF ( ). This includes, in particular, the risk factors described in Item 3 of the Form 20-F (and the contents of this section) and section 2 of the 2022 Universal Registration Document, as well as the update provided in section 2.5 of the 2023 Half-Year Business and Financial Report, of which the realization may have (or has had in some cases) material adverse effect on the Group and its activity, financial situation, results, development or perspectives, and which are of importance in the investment decision-making process. Half-year Consolidated Financial Results at June 30, 2023 The Condensed Consolidated Statements of Financial Position, Statements of Operations and Statements of Cash Flow of the Group were prepared in accordance with the IFRS. The limited review procedures on the condensed consolidated financial statements have been performed. The half-year consolidated financial statements for the period ended June 30, 2023 were approved by the Board of Directors on September 19, 2023. The condensed consolidated financial statements as well as the notes to the consolidated financial statements for the period ended June 30, 2023 and the statutory auditor’s report on the consolidated financial statements are included in the Half Year Business and Financial Report at June 30, 2023 available on the “Investors” page of the GENFIT website. All financial information (unless indicated otherwise) is presented in thousands of euros (€). Condensed Consolidated Statement of Financial Position Assets As of (in € thousands) 2022/12/31 2023/06/30 Current assets Cash and cash equivalents 136,001 111,826 Current trade and others receivables 15,906 20,184 Other current financial assets 4,550 0 Other current assets 1,998 2,578 Inventories 4 4 Total - Current assets 158,459 134,592 Non-current assets Intangible assets 43,957 46,182 Property, plant and equipment 8,210 8,144 Other non-current financial assets 4,914 4,986 Deferred tax assets 0 0 Total - Non-current assets 57,081 59,313 Total - Assets 215,540 193,905 Shareholders’ equity and liabilities As of (in € thousands) 2022/12/31 2023/06/30 Current liabilities Current convertible loans 415 415 Other current loans and borrowings 4,665 7,333 Current trade and other payables 14,845 21,705 Current deferred income and revenue 14,479 11,244 Current provisions 61 56 Other current tax liabilities 4,906 4,906 Total - Current liabilities 39,370 45,660 Non-current liabilities Non-current convertible loans 49,861 51,009 Other non-current loans and borrowings 20,334 16,665 Non-current trade and other payables 448 0 Non-current deferred income and revenue 9,706 4,746 Non-current employee benefits 782 813 Deferred tax liabilities 510 491 Total - Non-current liabilities 81,641 73,725 Shareholders' equity Share capital 12,459 12,459 Share premium 444,683 444,957 Retained earnings (accumulated deficit) (337,550) (360,902) Currency translation adjustment (1,344) (1,139) Net profit (loss) (23,719) (20,854) Total - Shareholders' equity 94,528 74,520 Total - Shareholders' equity & liabilities 215,540 193,905 Condensed Consolidated Statement of Operations Half-year ended (in € thousands, except earnings per share data) 2022/06/30 2023/06/30 Revenues and other income Revenue 8,790 11,482 Other income 3,398 3,893 Revenues and other income 12,188 15,374 Operating expenses and other operating income (expenses) Research and development expenses (17,599) (25,630) General and administrative expenses (8,229) (9,105) Marketing and market access expenses (460) (520) Reorganization and restructuring income (expenses) 179 633 Other operating expenses (423) (52) Operating income (loss) (14,344) (19,299) Financial income 6,182 1,748 Financial expenses (2,197) (2,890) Financial profit (loss) 3,985 (1,141) Net profit (loss) before tax (10,359) (20,440) Income tax benefit (expense) (40) (414) Net profit (loss) (10,399) (20,854) Basic and diluted earnings (loss) per share Basic earnings (loss) per share (€/share) (0.21) (0.42) Diluted earnings (loss) per share (€/share) (0.21) (0.42) Condensed Statement of Cash Flows Half-year ended Half-year ended (in € thousands) 2022/06/30 2023/06/30 Cash flows from operating activities + Net profit (loss) (10,399) (20,854) Reconciliation of net loss to net cash used in operating activities Adjustments for: + Depreciation and amortization on tangible and intangible assets 944 835 + Impairment and provision for litigation (74) (396) + Expenses related to share-based compensation 148 274 - Gain on disposal of property, plant and equipment 1 (52) + Net finance expenses (revenue) 1,057 763 + Income tax expense (benefit) 40 414 + Other non-cash items 1,095 1,199 Operating cash flows before change in working capital (7,188) (17,817) Decrease (increase) in trade receivables and other assets (5,071) (4,858) (Decrease) increase in trade payables and other liabilities (35,241) (2,398) Change in working capital (40,311) (7,256) Income tax paid 0 0 Net cash flows provided by (used in) in operating activities (47,499) (25,074) Cash flows from investment activities - Acquisition of intangible assets (14) (2,000) - Acquisition of property, plant and equipment 265 61 + Proceeds from disposal of / reimbursement of property, plant and equipment 0 62 - Acquisition of financial instruments (449) 9 + Proceeds from disposal of financial instruments 0 4,550 Net cash flows provided by (used in ) investment activities (199) 2,682 Cash flows from financing activities - Repayments of loans and borrowings (310) (464) - Payments on lease debts (593) (530) - Financial interests paid (including finance lease) (1,057) (1,106) + Financial interests received 17 337 Net cash flows provided by (used in ) financing activities (1,943) (1,764) Increase (decrease) in cash and cash equivalents (49,641) (24,155) Cash and cash equivalents at the beginning of the period 258,756 136,001 Effects of exchange rate changes on cash 0 (20) Cash and cash equivalents at the end of the period 209,115 111,826 Discussion of the 2023 half-year results Comments on the condensed statement of net income for the periods ended June 30, 2022 and June 30, 2023 (1) Revenue and other income The Company’s revenue and other income mainly comprises revenue, the research tax credit, and other operating revenue. Half-year ended (in € thousands) 2022/06/30 2023/06/30 Revenues 8,790 11,482 CIR tax credit 3,343 3,547 Government grants and subsidies 9 82 Other operating income 46 263 TOTAL 12,188 15,374 For the half-year ended June 30, 2023, total revenues and other income amounted to €15,374, compared with €12,188 for the same period in 2022. Revenues For the half-year ended June 30, 2023, revenue amounted to €11,482 in 2023 compared with €8,790 for the same period in 2022. Revenue is primarily composed of: The licensing agreement with Ipsen in December 2021 ("Collaboration and License Agreement"): during the first six months of 2023, €8.2 million was attributable to the partial recognition of deferred revenue as noted in note 21 - Deferred income and revenue in the 2023 Half Year Business and Financial Report, during the first six months of 2022, €8.2 million was attributable to the partial recognition of deferred revenue as noted in note 21 - Deferred income and revenue in the 2023 Half Year Business and Financial Report 2023. The Transition Services Agreement with Ipsen: in 2022 GENFIT and Ipsen entered into a Service Transition Agreement, which describes the scope of the services provided by GENFIT to Ipsen in order to facilitate the transition of certain activities related to the Phase 3 clinical trial, evaluating elafibranor in PBC. during the first six months of 2023, services provided under this contract generated €3.2 million in revenue during the first six months of 2022, services provided under this contract generated €0.6 million in revenue. Research Tax Credit For the half-year ended June 30, 2023, the research tax credit amounted to €3,547 in 2023 (€3,343 for the same period in 2022), due to an increase in research and development activity. The research tax credit receivable amounted to €14,847 as of June 30, 2023, €6,017 of which relates to 2022 and €5,282 of which relates to 2021. The balance for 2021 and 2022 has not yet been reimbursed in 2023 given the ongoing tax audit. Other operating income During the first six months of 2023, the Group recognized €263 in “Other operating income” (€46 for the same period in 2022), mainly comprised of exchange gains on trade receivables. (2) Operating expenses by destination The tables below break operating expenses down by destination, mainly into research and development expenses, general and administrative expenses, marketing and market access expenses, and restructuring and reorganization expenses. Half-year ended Of which : 2022/06/30 Raw Contracted Employee Other Depreciation, Gain / materials research and expenses expenses amortization (loss) on and development (maintenance, and disposal of consumables activities fees, travel, impairment property, used conducted by taxes…) charges plant and (in € thousands) third parties equipment Research and development expenses (17,599) (1,052) (8,538) (4,889) (2,408) (712) 0 General and administrative expenses (8,229) (133) (38) (3,230) (4,580) (248) 0 Marketing and market access expenses (460) (2) 0 (272) (182) (3) 0 Reorganization and restructuring income (expenses) 179 0 0 0 (1) 180 0 Other operating expenses (423) 0 0 0 (422) 0 (1) TOTAL (26,532) (1,187) (8,576) (8,391) (7,594) (783) (1) Half-year ended Of which : 2023/06/30 Raw Contracted Employee Other Depreciation, Gain / materials research and expenses expenses amortization (loss) on and development (maintenance, and disposal of consumables activities fees, travel, impairment property, used conducted by taxes…) charges plant and (in € thousands) third parties equipment Research and development income (expenses) (25,630) (1,040) (14,367) (6,299) (3,251) (705) 33 General and administrative expenses (9,105) (162) (96) (3,919) (4,645) (283) 0 Marketing and market access expenses (520) (2) (1) (275) (236) (6) 0 Reorganization and restructuring income (expenses) 633 0 0 0 0 633 0 Other operating income (expenses) (52) 0 0 0 (75) 3 20 TOTAL (34,673) (1,204) (14,464) (10,492) (8,207) (358) 52 For the half-year ended June 30, 2023, operating expenses amounted to €34,673 (€26,532 for the same period in 2022). They include the following: Research and development expenses For the first six months of 2022, research and development expenses totaled €17.6 million, or 66.3% of our total operating expenses. These expenses were comprised of €8.5 million in contracted research and development conducted by third parties, €4.9 million in employee expenses, €2.4 million in other expenses, €0.7 million in depreciation, amortization and impairment charges and €1.1 million in raw materials and consumables. For the first six months of 2023, research and development expenses totaled €25.6 million, or 72.8% of our total operating expenses. These expenses were comprised of €14.4 million in contracted research and development conducted by third parties, €6.3 million in employee expenses, €3.3 million in other expenses, €0.7 million in depreciation, amortization and impairment charges and €1.0 million in raw materials and consumables. The increase of €5.8 million in contracted research and development conducted by third parties is mainly due to: Increasing costs related to the ELATIVE® product candidate of €2.8 million, Increasing costs related to the VS-01 product candidate of €2.3 million, Increasing costs related to the GNS561 product candidate of €2.3 million, Increasing costs related to the NTZ product candidate €2.6 million, and The elafibranor project in NASH which recorded a final accrual reversal of €(1) million, which did not repeat in 2023. The increase of €1.4 million in employee expenses, consisting of wages, salaries, social security, pension costs and share-based compensation paid to employees in the research and development function, relates primarily to the increase in workforce (from 82 to 96 employees at June 30, 2022 and 2023, respectively). This includes a 7 person increase due to the Versantis acquisition. The increase of €0.8 million in other expenses is mainly due to increasing costs related to consultants of €0.7 million, increasing costs related to patent applications of €0.1 million, decreasing costs related to recruiting fees of €0.1 million and increasing costs related to rent expenses of €0.1 million. General and administrative expenses For the first six months of 2022, general and administrative expenses totaled €8.2 million. These expenses were mainly comprised of €3.2 million in employee expenses and €4.6 million in other expenses. For the first six months of 2023, general and administrative expenses totaled €9.1 million. These expenses were mainly comprised of €3.9 million in employee expenses and €4.6 million in other expenses. The increase in general and administrative employee expenses was mainly due to the increase in workforce (from 50 to 56 employees at June 30, 2022 and 2023, respectively). Other expenses remained stable period over period. Marketing and market access expenses For the first six months of 2022, marketing and market access expenses totaled €0.5 million. These expenses were mainly comprised of €0.3 million in employee expenses and €0.2 million in other expenses. For the first six months of 2023, marketing and market access expenses totaled €0.5 million. These expenses were mainly comprised of €0.3 million in employee expenses and €0.2 million in other expenses. Marketing and market access expenses remained stable period over period. Reorganization and restructuring income (expenses) For the first half of 2022, reorganization and restructuring income amounted to €0.2 million. For the first half of 2023, reorganization and restructuring income amounted to €0.6 million. During the first half of 2023, the Group reversed the entire remaining RESOLVE-IT provision consisting of un-used building space, which is now in use. (3) Financial income (expense) For the half-year ended June 30, 2023, financial income amounted to a loss of €1.1 million, compared to a gain totaling €4.0 million for the same period in 2022. For the first six months of 2022, the €4 million gain is a result of €6.0 million in realized and unrealized foreign exchange gains and €0.2 million in accrued and realized interest income, offset by interest expense of €2.2 million. For the first six months of 2023, the €1.1 million loss is a result of €2.3 million in interest expense coupled with €0.4 million in foreign exchange losses, partially offset by €1.6 million in accrued and realized interest income. (4) Net income (loss) The first half of 2023 resulted in a net loss of €20,854 thousand compared with a net loss of €10,399 thousand in the first half of 2022. Comments on the Group’s Cash Flows for the periods ended June 30, 2022 and June 30, 2023 As of June 30, 2023, cash and cash equivalents and other current financial assets amounted to €111,826. Over the period, change in cash flow by type of flow was as follows: Half-year ended Half-year ended (in € thousands) 2022/06/30 2023/06/30 Cash flows provided by (used in) operating activities (47,499) (25,074) Cash flows provided by (used in) investment activities (199) 2,682 Cash flows provided by (used in) financing activities (1,943) (1,764) (49,641) (24,155) (1) Cash flows provided by (used in) operating activities Cash flow used in operating activities amounted to an outflow of €25,074 thousand for the half-year ended June 30, 2023 compared with an outflow of €47,499 thousand for the half-year ended June 30, 2022. In the first half of 2023, this amount mainly stems from our net loss of €20,854 thousand, which is largely the result of our research and development efforts, notably for ELATIVE®, our Phase 3 clinical trial of elafibranor in PBC; UNVEIL-IT™, our Phase 2 clinical trial of VS-01 in ACLF; GNS561, as part of our cholangiocarcinoma program; and NTZ, as part of our ACLF program. In the first half of 2022, these cash flows include the disbursement of €24,000 thousand corresponding to the VAT on the upfront payment received from Ipsen under the licensing agreement entered into in December 2021, as well as the disbursement of the employee participation to the profits of GENFIT SA for a total of €628 thousand. These cash flows reflect GENFIT’s business, which requires significant research and development efforts, and generates expenses that change in line with progress on the Company’s research programs, net of its operating revenues. (2) Cash flows provided by (used in) investing activities Cash flow used in investing activities amounted to €2,682 thousand in the first half of 2023, compared with €(199) thousand in cash flow provided in the first half of 2022. These cash flows include acquisitions, disposals and repayments of fixed assets and financial assets. (3) Cash flows provided by (used in) financing activities Cash flow used in financing activities amounted to €1,764 thousand in the first half of 2023, compared with €1,943 thousand in the first half of 2022. In the first half of 2023, these cash flows mainly reflect financial interest received and paid, the amount of which is stable compared with the first half of 2022. ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe 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. Thanks to its expertise in bringing early-stage assets with high potential to late development and pre-commercialization stages, today GENFIT boasts of a successful Phase 3 trial (ELATIVE®) evaluating elafibranor in Primary Biliary Cholangitis (PBC) and a growing and diversified pipeline of innovative therapeutic and diagnostic solutions. Its R&D pipeline covers six therapeutic areas via eight programs which explore the potential of differentiated mechanisms of action, across a variety of development stages (pre-clinical, Phase 1, Phase 2, Phase 3). These diseases are acute on chronic liver failure (ACLF), hepatic encephalopathy (HE), cholangiocarcinoma (CCA), urea cycle disorders (UCD), organic acidemias (OA) and PBC. Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic franchise focused on NASH and ACLF. 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 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 GENFIT’s corporate strategy and objectives, our ability to meet milestones and receive payments from Ipsen, the potential of elafibranor to receive marketing authorization and successful launch and commercialization in PBC by Ipsen, anticipated timing for study enrollment and data readouts and development plans for our pipeline programs, expected timing for potential regulatory approvals and the impact of the development of our programs and our internal organization, our ability to qualify for and obtain specific regulatory pathways, as well as our financial outlook including cash flow and cash burn projections and business activity projections for 2023 and beyond. 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 ( ) and on the website of the AMF ( ) 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. CONTACT GENFIT | Investors Tel : + 33 3 20 16 40 00 | investors@genfit.com GENFIT | Press relations Stephanie BOYER | Tel : + 33 3 20 16 40 00 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | 1 The Half Year Business and Financial Report is available to the public and was filed with the French Autorité des Marchés Financiers (French Financial Markets Authority) and filed with the U.S. Securities and Exchange Commission today. The condensed consolidated financial statements are included in this press release and the complete financial statements are included in the Half-Year Business and Financial Report which is available on the “Investors” page of the GENFIT website. 2 Including HE as a therapeutic area closely associated with ACLF 3 European Association for the Study of the Liver 4 It was decided at the EASL Congress 2023 that Metabolic dysfunction-associated steatohepatitis (MASH) is the replacement term for nonalcoholic steatohepatitis (NASH) Attachment PR - GENFIT Reports 1H23 Financial Results