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July 26, 2021 13:05 UTC Cortexyme Presents Data Linking P. Gingivalis to Elevated Levels of Phospho-tau217 Reinforcing Evidence of Pathogen as Causative Agent of Alzheimer’s Disease at AAIC 2021 New GAIN Trial baseline data demonstrates majority of patients have elevated Von Willebrand factor and alpha-2-macroglobulin Cortexyme to host AAIC symposium titled “Getting to the Root Cause of Alzheimer’s Disease: An Innovative, Upstream Approach for Disease Modification” on Tuesday, July 27 Join KOL webinar on atuzaginstat titled “Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration” on Friday, July 30 at 10 a.m. ET SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal trial in Alzheimer’s disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the presentation of new preclinical data linking P. gingivalis to increased levels of phospho-tau217, an emerging biomarker for Alzheimer’s disease. This research, along with new baseline data from its pivotal GAIN Trial, is being presented by the company at the Alzheimer's Association International Conference® 2021 (AAIC®) taking place July 26-30, 2021, in Denver, Colorado, as well as virtually. In addition to its presentations, Cortexyme will host a corporate sponsored symposium held in conjunction with the conference titled “Getting to the Root Cause of Alzheimer’s Disease: An Innovative, Upstream Approach for Disease Modification” on Tuesday, July 27, 2021, from 5:30 p.m. to 7:30 p.m. MT. “Cortexyme continues to conduct research that validates and reinforces the gingipain hypothesis and P. gingivalis’ role as a causative agent of Alzheimer’s disease,” said Casey Lynch, Cortexyme’s chief executive officer, co-founder, and chair. “The GAIN Trial, which is designed to be 90% powered to show a 50% slowing of disease, will read out on the gold standard measures of disease modification as Cortexyme looks to shift the paradigm in effective Alzheimer’s treatment.” Cortexyme is pioneering an innovative, upstream, and disease-modifying therapeutic approach to Alzheimer's disease. The Phase 2/3 GAIN Trial is a potentially pivotal study in 643 patients with mild to moderate Alzheimer’s Disease. Cortexyme’s seminal discovery, along with confirmatory clinical and preclinical studies, demonstrate that the intracellular pathogen, P. gingivalis, is found in the brain of more than 90% of Alzheimer’s patients and that a simple oral infection with P. gingivalis in animals results in brain infiltration and downstream hallmark Alzheimer’s pathologies, including Aβ42 production, tau hyperphosphorylation, microglial activation, and neurodegeneration. The company’s lead drug candidate, atuzaginstat (COR388), is a first-in-class, orally administered, brain penetrant small molecule targeting P. gingivalis, which is upstream of neuronal death and Alzheimer’s disease pathology. Atuzaginstat blocks gingipains, protease virulence factors secreted by P. gingivalis, which are required for its survival and responsible for its toxicity. The GAIN Trial also includes a REPAIR sub-study of 233 patients targeting P. gingivalis – most commonly known as a keystone bacterium associated with periodontal disease – and measuring the efficacy of atuzaginstat on clinical endpoints of periodontal disease. Cortexyme’s innovative therapeutic approach continues to be supported by research from laboratories around the world published in peer-reviewed scientific journals. Cortexyme’s work will be featured in two poster presentations at AAIC 2021: Increased Levels of Phospho-tau217 Linked to P. gingivalis Reduced by Atuzaginstat: In its poster “Increased levels of phospho-tau217 in neuron cultures and CVN mice infected with Porphyromonas gingivalis” (Poster #52438), Cortexyme demonstrates P. gingivalis infected neuronal cell cultures and chronically infected CVN mice display elevated tau phosphorylation at T217 (phospho-tau217). Using IPSC-derived neuron cultures, neuron-astrocyte-microglia co-cultures, and CVN mice (APPSwDI/NOS2 bigenic) as model systems for P. gingivalis-induced Alzheimer’s disease, the company demonstrated that phospho-tau217 was susceptible to P. gingivalis-induced and gingipain dependent digestion in a dose-dependent manner. At lower infection levels, tau protein persisted and an elevated phospho-tau217/total tau ratio was observed in a manner that might reflect the physiological level of gingipain exposure. In CVN mice chronically infected with P. gingivalis, the phospho-tau217/total tau ratio was elevated in the brain in infected compared to uninfected mice. Furthermore, after five weeks of treatment with atuzaginstat, the level of phospho-tau217 was similar to that seen in uninfected controls, while tau degradation was completely inhibited by treatment with atuzaginstat. New Baseline Data from GAIN Trial: In its poster titled “An update and baseline data from the Phase 2/3 GAIN trial of COR388 (atuzaginstat) a novel bacterial virulence factor inhibitor for the treatment of Alzheimer’s Disease” (Poster #50624), Cortexyme shares updated and new baseline biomarker data from the full set of patients in the study that supports that this is an appropriate population for testing atuzaginstat for Alzheimer’s disease. In addition to demonstrating that 100% of patients have evidence of systemic P. gingivalis exposure, GAIN baseline biomarker highlights include traditional CSF biomarkers Aβ, total tau, and phospho-tau 181. New data shows that a majority of patients have elevated Von Willebrand factor (vWF), a vascular injury marker, and alpha-2-macroglobulin (A2M), an endogenous protease inhibitor, in serum. GAIN baseline demographics also demonstrate that 90% of its periodontal disease REPAIR sub-study patients have moderate to severe periodontitis without requiring it as a criterion for study participation. Cortexyme AAIC Symposium – Getting to the Root Cause of Alzheimer’s Disease Cortexyme will host a corporate sponsored symposium and dinner held in conjunction with AAIC 2021 titled “Getting to the Root Cause of Alzheimer’s Disease: An Innovative, Upstream Approach for Disease Modification” on Tuesday, July 27, 2021, from 5:30 p.m. to 7:30 p.m. MT at the Hilton Denver City Center. Led by Cortexyme’s chief executive officer and co-founder Casey Lynch and chief medical officer Michael Detke, M.D., Ph.D., the symposium will provide an informative presentation on how Cortexyme is moving beyond the prevailing targets to deliver a game-changing shift in Alzheimer’s disease treatment. For AAIC 2021 registered participants wishing to attend Cortexyme’s symposium in person, please email info@cortexyme.com to sign up. The symposium also may be accessed online by registering to attend AAIC 2021 through its virtual conference experience here. KOL Webinar: Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration In conjunction with its participation at AAIC 2021, Cortexyme is hosting a key opinion leader (KOL) webinar titled “Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration” on Friday, July 30, 2021, at 10:00 a.m. ET. The webinar will feature KOL Marwan Noel Sabbagh, M.D., (Cleveland Clinic) who will discuss the current treatment landscape of Alzheimer’s disease and dementia, the unmet medical need, as well as recent activity and evidence to support the role of P. gingivalis as an important upstream driver of Alzheimer’s disease pathology. Dr. Sabbagh will also address new baseline data from Cortexyme’s pivotal Phase 2/3 GAIN Trial of atuzaginstat for the treatment of Alzheimer’s disease being presented at AAIC 2021. Cortexyme's management team will provide an update on its ongoing pivotal Phase 2/3 GAIN Trial, which builds on Phase 1 data demonstrating atuzaginstat was well tolerated in both healthy subjects and in patients with Alzheimer’s disease. Dr. Sabbagh and Cortexyme’s management will be available to answer questions following the formal presentations. To register for this webinar, please click here. Marwan Noel Sabbagh, M.D., board certified neurologist and geriatric neurologist, hopes to work himself out of a job. Considered one of the leading experts in Alzheimer’s and dementia, he is the Camille and Larry Ruvo Endowed Chair for Brain Health and Director of Translational Research at Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. Dr. Sabbagh has dedicated his career to finding a cure for Alzheimer’s and other age-related neurodegenerative diseases. Dr. Sabbagh is a leading investigator for many prominent national Alzheimer’s prevention and treatment trials. Dr. Sabbagh is on the editorial board for Journal of Alzheimer's Disease and BMC Neurology. He is now editor in chief of Neurology and Therapy. He has authored and co-authored almost 370 medical and scientific articles on Alzheimer’s research. Dr. Sabbagh is the author of The Alzheimer’s Answer: Reduce Your Risk and Keep Your Brain Healthy, with foreword by Justice Sandra Day O’Connor, and The Alzheimer’s Prevention Cookbook: 100 Recipes to Boost Brain Health. He has edited Palliative Care for Advanced Alzheimer’s and Dementia: Guidelines and Standards for Evidence Based Care and Geriatric Neurology published in 2014 and Fighting for my Life: living in the shadow of Alzheimer’s disease published in 2019. He has been recognized with numerous awards, including WestMarc Innovator Award, 2015; Fellow of the American Academy of Neurology, 2004. Dr. Sabbagh earned his undergraduate degree from the University of California, Berkeley and his medical degree from the University of Arizona in Tucson. He received his residency training in neurology at Baylor College of Medicine, Houston, Texas, and completed his fellowship in geriatric neurology and dementia at the University of California, San Diego School of Medicine, where he served on the faculty as assistant professor. Before joining the faculty of the Cleveland Clinic, he was at the Barrow Neurological Institute where he served for three years, and prior to that he was the director of the Banner Sun Health Research Institute for 15 years. About Cortexyme Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer’s and other degenerative diseases. The company is advancing its disease-modifying pivotal GAIN Trial in mild to moderate Alzheimer's disease with top-line data expected in the fourth quarter of 2021, in addition to growing a proprietary pipeline of first-in-class small molecule therapeutics for Parkinson’s disease, periodontitis, and other diseases with high unmet clinical need. Cortexyme’s lead program targets a specific, infectious pathogen called P. gingivalis found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. The company’s causation evidence for Alzheimer’s disease and the mechanism of its novel therapeutic has been independently replicated and confirmed by multiple laboratories around the world, as well as published in peer-reviewed scientific journals. To learn more about Cortexyme, visit or follow @Cortexyme on Twitter. Forward-Looking Statements Statements in this news release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this news release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast,” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans, strategy, timeline, prospects, and milestone expectations; the timing and success of the company’s clinical trials and related data, including with respect to the GAIN and REPAIR Trials; the potential of atuzaginstat to treat Alzheimer’s disease, periodontal disease, and other potential indications; the timing of announcements and updates relating to its clinical trials and related data; the potential therapeutic benefits, safety and efficacy of the company’s product candidate or library of compounds and statements about its ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to the company’s drug product candidate. Forward-looking statements are based on Cortexyme’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in Cortexyme’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, its Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

Innovative multi-biomarker blood test based on GENFIT’S NIS4™ technology is specifically designed to identify patients with at-risk non-alcoholic steatohepatitis (NASH) LabCorp to commercialize the test for clinical care use in U.S. and Canada to help identify the approximately 10 million individuals at risk of progressing to late stage complications due to NASH among the tens of millions of people with metabolic risk factors and suspected disease The test is expected to be available from LabCorp by early 2021 Lille, France; Cambridge, MA; [AND Burlington, N.C.,] September 28, 2020 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, and LabCorp® (NYSE:LH), a leading global life sciences company that is focused on advancing health and guiding patient care decisions, have agreed to a five-year exclusive licensing agreement for GENFIT’s NIS4™ technology to help identify patients with at-risk non-alcoholic steatohepatitis (NASH). As part of the agreement, LabCorp will develop and commercialize a blood-based molecular diagnostic test powered by NIS4™ technology throughout the U.S. and Canada enabling widespread access to healthcare providers. NASH remains a highly underdiagnosed disease due to its asymptomatic nature and the limitations of existing diagnostic approaches. Liver biopsy, a highly invasive procedure, is the current clinical standard to formally diagnose NASH and to determine the stage of fibrosis. NIS4™ technology, as recently published in The Lancet Gastroenterology & Hepatology (available here ), is a novel, multi-biomarker-based algorithm specifically developed to identify at-risk NASH, defined as the presence of NASH based on a non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) ≥4 and significant to advanced fibrosis (F≥2). Patients with at-risk NASH have an advanced form of the disease and face a greater likelihood of progression to severe complications including liver cancer, cirrhosis and the need for liver transplant, if left untreated. A single test score generated from the integration of four independent biomarkers – miR-34a-5p, alpha-2-macroglobulin, YKL-40, and HbA1c – can be used by a healthcare provider to help inform the best course of intervention. This agreement with LabCorp will provide broad clinical availability of the test to specialty and primary care physicians across the U.S. and Canada. LabCorp will leverage its deep experience in commercializing innovative diagnostics to educate providers on NASH and the importance of non-invasive testing. The collaboration between the organizations began in early 2019, when LabCorp began offering NIS4™ technology to biopharmaceutical customers for use in clinical studies through Covance, its drug development business. Marcia Eisenberg, Ph.D., Chief Scientific Officer of LabCorp Diagnostics, stated: “LabCorp is committed to developing and distributing novel diagnostics to support the diagnosis of patients with NASH, which is one of the fastest growing serious medical conditions in the U.S. GENFIT’s NIS4™ is a non-invasive technology specifically designed to identify patients with both NASH and significant to advanced fibrosis, and is an important advance in the ability to identify patients with NASH. We have gained valuable experience with this test since we began performing it in 2019 for clinical studies with biopharmaceutical clients, which will provide insights as we develop and prepare to make it available for use in patient care.” Suneil Hosmane, Ph.D., Head of Global Diagnostics at GENFIT added: “We are pleased to expand our collaboration with LabCorp and are very enthusiastic about the potential impact of this agreement. We strongly believe that this test will help healthcare providers identify the approximately 10 million patients with at-risk NASH and higher risk of progression among the tens of millions with metabolic risk factors, such as type 2 diabetes and obesity, and suspected disease.” Pascal Prigent, CEO of GENFIT, continued, “This partnership supports GENFIT’s pioneering research efforts in the field of NASH diagnostics that were recently recognized by experts in our most recent Lancet publication. The commercialization of NIS4™ technology by LabCorp is a defining opportunity whereby millions of NASH patients can become aware of, and then begin to take control of their disease.” GENFIT is a pioneer in NASH diagnostics and is committed to the development of additional diagnostics and therapeutics in chronic liver disease. LabCorp has been involved in the development of drugs and diagnostics for more than 50 years and is a recognized global leader in NASH clinical trials. Specific financial terms for this agreement have not been disclosed. ABOUT NIS4™ NIS4™ is GENFIT’s non-invasive, blood-based diagnostic technology, which was developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F > 2), also referred to as at-risk NASH. In January 2019, GENFIT signed a licensing agreement with LabCorp® to make NIS4™ technology available for use in clinical research through their drug development subsidiary, Covance. GENFIT also continues to explore opportunities to obtain formal marketing authorization of an in vitro diagnostic (IVD) version of NIS4™ in both the U.S. and European markets. For more information, please visit: . ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases. GENFIT is a pioneer in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades. GENFIT initiated a Phase 3 clinical trial of elafibranor in patients with primary biliary cholangitis (PBC). As part of GENFIT’s comprehensive approach to clinical management of patients with liver disease, the Company is also developing NIS4™, a new, non-invasive blood-based diagnostic technology which, if approved, could enable easier identification of patients with at-risk NASH. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 200 employees. 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). 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 statements about NIS4™’s performance in identifying patients with at-risk NASH, the performance of NIS4™ relative to other technologies, the potential for diagnostic tests powered by NIS4™ technology to play a critical role in the diagnosis and management of patients with NASH, the potential for non-invasive testing to gain importance, its capability to identify patients who may require medical intervention, the development plans for NIS4™ in the U.S. and in Europe and timing of such development plans, and the potential to obtain formal marketing authorization of an IVD version of NIS4™ in the U.S. and/or European markets. 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 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 2.1 “Main Risks and Uncertainties” of the Company’s 2019 Universal Registration Document filed with the AMF on May 27, 2020 under n° D.20-0503, which is available on GENFIT’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 20-F dated May 27, 2020. 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. ABOUT LABCORP LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit , and to learn more about LabCorp’s Covance Drug Development business, visit . LABCORP FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, including but not limited to statements with respect to clinical laboratory testing, including a testing in development based on GENFIT’s NIS4™ technology, the impact of various factors on operating and financial results, and the opportunities for future growth. Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the Company’s control, including without limitation, competitive actions and other unforeseen changes and general uncertainties in the marketplace, changes in government regulations, including healthcare reform, customer purchasing decisions, including changes in payer regulations or policies, other adverse actions of governmental and third-party payers, the Company’s satisfaction of regulatory and other requirements, patient safety issues, changes in testing guidelines or recommendations, adverse results in material litigation matters, failure to maintain or develop customer relationships, our ability to develop or acquire new products and adapt to technological changes, failure in information technology, systems or data security, and employee relations. These factors, in some cases, have affected and in the future (together with other factors) could affect the Company’s ability to implement the Company’s business strategy and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the Company’s most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the Company’s other filings with the SEC. GENFIT CONTACT GENFIT | Investors Naomi EICHENBAUM – Investor Relations | Tel: +1 (617) 714 5252 | investors@genfit.com PRESS RELATIONS | Media Hélène LAVIN – Press Relations | Tel: +3 33 2016 4000 | Helene.lavin@genfit.com LABCORP CONTACTS Clarissa Willett – Investors | Tel: +1 (336) 436 5076 | Investor@LabCorp.com Donald Von Hagen – Media | Tel: +1 (336) 436 8263 | Media@LabCorp.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | Attachment

Completion of enrollment of approx. 1000-patient study cohort for Phase 3 RESOLVE-IT study, on the basis of which conditional marketing approval for elafibranor in NASH could be obtained in 2020. Interim data readout expected by end of 2019. › Completion of enrollment of approx. 1000-patient study cohort for Phase 3 RESOLVE-IT study, on the basis of which conditional marketing approval for elafibranor in NASH could be obtained in 2020. Interim data readout expected by end of 2019. › Completion of patient enrollment for Phase 2 study evaluating elafibranor in PBC. Top- line data readout expected end of 2018. › Agreement by FDA on the Pediatric Study Plan for elafibranor with a view to launching a NASH pediatric clinical trial in the United States. › Half year results reflect these advances. Lille (France), Cambridge (Massachusetts, United States), September 24, 2018 – GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical group at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces its 2018 half year financial results. It’s 2018 half year business and financial report was made available to the public and filed with the Autorité des marchés financiers (“AMF”) today. A summary of the consolidated financial statements is included in this press release. The 2018 half-year consolidated financial statements are available on the “Investors” page of the GENFIT website. Jean-François Mouney, Chairman & CEO of GENFIT, commented: “Our half-year results mainly reflect the significant efforts and advances made in the elafibranor clinical development program. Firstly in NASH, with the enrollment of the last patient of the 1000-patient study cohort that will serve as the basis for conditional marketing approval which could be obtained for elafibranor in 2020. We are eagerly awaiting the top line interim data of the trial that are expected for end 2019. Enrollment of the Phase 2 trial evaluating elafibranor in PBC was also completed two months ago, which should allow us to obtain top line data by the end of this year. This first half of year also saw FDA agreement on the Pediatric Study Plan for elafibranor, allowing us to launch a pediatric clinical trial in NASH in the United-States in the upcoming weeks. With respect to the other programs, we are focusing our efforts in the upcoming months on in reaching an agreement with an industrial player that will accelerate the development of our new NASH in vitro diagnostic tool that we would like to develop with a partner. We’re also expect to launch a phase 2a trial in the United States to evaluate nitazoxanide in patients with NASH with advanced fibrosis. The expected clinical results could lead to the deployment of our medium-term strategy aimed at progressively transforming GENFIT into a biopharmaceutical company specialized in liver diseases of metabolic origin and hepatobiliary diseases, generating revenue from total or partial transfer of the marketing rights to its products, and from direct sales in given territories in indications such as NASH and PBC.” Main financial results: Key aspects of the half-year 2018 results are: cash and cash equivalents of €238 million at June 30, 2018 (€273.8 million at December 31, 2017). Operating income of €5.1 million (€4.7 million at June 30, 2017), essentially from the Research Tax Credit, which amounted to €5 million for the first half 2018 (€4.5 million in the preceding half year) translating the increase in operating expenses relating to the progression of the R&D portfolio between both half-years. Operating expenses of €36.7 million (€27.1 million at June 30, 2017) of which 89% represented R&D expenses. The increase in operating expenses is due : mainly, to the increase in contracted research and development expenses (from €14.3 million at June 30, 2017 to €22.7 million at June 30, 2018) resulting from the progress of the R&D program pipeline, of which the majority relate to expenses for the Phase 3 RESOLVE-IT study of elafibranor in NASH; and to a lesser extent, an increase in personnel expenses (from €5.5 million excluding share-based payments on June 30, 2017 to €6 million excluding share-based payments) and other operating expenses (from €5.2 million at June 30, 2017 to €5.9 million at June 30, 2018) mainly related to the increase in communication expenses, payroll taxes and expenses related to maintenance of equipment at Company headquarters. As a result of changes in revenues and expenses, the net loss amounted to €34.5 million at June 30, 2018 (€22.6 million at June 30, 2017). As a reminder, the net loss for the 2017 financial year was €58.6 million. The following table summarizes the Consolidated Statement of Operations under IFRS for the first half 2018, with comparative figures for the first half 2017. The summary IFRS consolidated financial statements at June 30, 2018 as well as the management discussion of the results, are presented in the appendix at the end of this document. The full consolidated financial statements as well as statutory auditors’ report on the consolidated financial statements are included in appendices of the Half Year Report at June 30, 2018 and available on the “Investors” page of the GENFIT website. Key events of the first half 2018 and main post closing event o Elafibranor development program in NASH NASH, for Non Alcoholic Steato Hepatitis, is a liver disease that associates a buildup of fat in the liver, inflammation and degeneration of liver cells. The disease is associated with a high risk of progression to cirrhosis, a condition consistent with impaired liver function, leading to liver failure and liver cancer. RESOLVE-IT Phase 3 study in NASH Enrollment of patients in the RESOLVE-IT Phase 3 of elafibranor in NASH study progressed actively during the course of the first half 2018, taking care to ensure enrollment quality in order to produce the most statistically robust clinical trial and ensure that patient stratification ratios remain as close as possible to the medical reality. Thus, during the half year and based on its past experience, the Company paid close attention to the following factors: Ethnically-balanced enrollment, even if the diversity sought creates administrative delays, in particular in certain countries in South America; Balance between the two arms of the study in each study center, leading to the selection of those centers which are able to mobilize a sufficiently large number of potentially eligible patients; Balance within the randomized patient population (gender, disease severity) and among geographical regions of enrollment. With these precautions and despite the need, in this context, to open more clinical research centers, the Company was able to announce in April the enrollment of the first ~1000 patients participating in the first phase of the trial serving as the foundation for conditional marketing approval which could be granted in 2020. End April, the Company also announced the results of the 24 month review of the Data Safety Monitoring Board (DSMB), based on tolerability and safety data. The DSMB issued a positive recommendation for the continuation of the RESOLVE-IT Phase 3 trial in NASH without any modifications. Pediatric Program In January 2018, the Company announced the official launch of the pediatric program of elafibranor in NASH following the FDA’s (Food and Drug Administration) agreement of the Pediatric Study Plan (PSP) for launching the pediatric clinical trial of elafibranor in NASH in the United States. This FDA agreement is in line with the agreement already obtained previously on the pediatric investigation plan (PIP) by the EMA (European Medicines Agency). Progress in the disease awareness program in NASH In 2017, the Company launched a disease awareness initiative through the endowment fund it founded, The NASH Education Program™, confirming its leadership in this therapeutic area, and sparked an unprecedented wave of interest in the French media. This initiative is crucial in the context of enrollment for a little known and asymptomatic pathology like NASH. Welcomed by a growing number of specialists in the sector, the endowment fund’s initiatives were extended to other countries in the first half of 2018 with the organization of the first International NASH Day. This inaugural event, which saw support from other commercial companies and large learned societies and international patient associations, contributed significantly to spreading awareness of the disease internationally. Events (conferences, screenings, street events, ...) were organized in more than 20 countries, awareness programs broadcast on a Web TV dedicated to the International NASH Day in six languages and benefitted from important international media coverage. Opportunities in combination therapy To address the multifactoral nature of the disease and the multiple co-morbidities that NASH patients face, the Company continued to evaluate, over the course of the first half of the year, the therapeutic potential of the following combinations with elafibranor: compounds from other GENFIT programs, the most advanced compounds in the current NASH clinical landscape. The goal is to treat the largest number of NASH patients, and if possible, using reduced dosages of the drugs to be combined with elafibranor. New preclinical data in the development of NAFLD / NASH-related cancers In June 2018, the Company announced new preclinical results indicating that elafibranor has anti-tumor development activity in the context of NAFLD/NASH-induced hepatocellular carcinoma (HCC). This provides further evidence of elafibranor’s potential as a pivotal treatment for combination therapy, adding to its ability to resolve NASH without aggravating fibrosis and contributing to cardiovascular protection, reducing the risk of developing HCC. ·Elafibranor development program in Primary Biliary Cholangitis (PBC) PBC, for Primary Biliary Cholangitis, is a rare autoimmune disease characterized by the progressive destruction of the intrahepatic bile ducts that may lead to cirrhosis or liver failure. Recruitment of patients with an inadequate response to ursodeoxycholic acid for the phase 2a study to evaluate the efficacy and safety of elafibranor in PBC continued actively throughout the first half of the year. As of the date of this report, the Company has announced that the last of the 45 patients to be enrolled in this trial have been recruited and that a number of patients have already completed their 12-week treatment. This phase 2a trial is being carried out as follows: 3 arms: elafibranor 80mg, 120mg, placebo 45 patients (15 patients per arm) 12 weeks treatment International, multicenter study in the U.S. and in Europe The primary objective is to determine the effect of daily oral administration of elafibranor on serum alkaline phosphatase (ALP) in these patients, based on relative change from baseline to end of treatment compared to placebo. Secondary endpoints will include: ALP 15% decrease in ALP Paris, Toronto, UK PBC scores Pruritus and QoL (Quality of Life) Safety of elafibranor in a PBC population The preliminary study results should be available, subject to meeting the Company’s estimated timelines for their analysis, at the end of 2018. ·Diagnostic biomarker program in NASH (BMGFT03) At the 2017 International Liver Congress organized by EASL, the Company presented the latest advances in its biomarker program and development opportunities for a non-invasive in-vitro diagnostic (IVD) test in NASH. The Company presented new data on: Identification of a simplified diagnostic score to identify NASH patients and monitor their disease evolution; new advances in research in miRNAs with diagnostic value. These new, innovative miRNAs were identified by analyzing samples of over 500 NAFLD patients from different cohorts, including those from the RESOLVE-IT Phase 3 study. The scoring method is the result of identifying a new algorithm based on a smaller number of variables, generating a powerful score with good performance based on AUROC (Area Under the Receiver Operating Curve), sensitivity, specificity, NPV (Negative Predictive Value) and PPV (Positive Predictive Value). The two presentations confirmed the potential of the approach developed by the Company and its ability to provide an IVD solution based on a blood test which is non-invasive, easy to use, and at lower cost and thus able to be widely available compared with other existing approaches or those in development. Although these other approaches, such as imaging and elastography, are complementary, they nevertheless require greater investment in equipment and training and would not, in any case, be able to replace a widely available point-of-care IVD tool. Other results announced in 2017 confirmed the diagnostic potential of circulating microRNAs and the relevance of GENFIT’s signature to identify patients with active NASH (NAS≥4) and significant fibrosis (F≥2): in the GOLDEN-505 cohort (the cohort from the phase 2b trial of elafibranor in NASH) and in a cohort of obese patients and a previously described signature (NIS 4) combining miR-34a, alpha-2 macroglobulin, HbA1c and YKL-40 has a significantly better diagnostic performance than other main scores described in scientific literature, when tested in both GOLDEN-Diag and RESOLVE-IT cohorts. This data allowed the Company to finalize the feasibility stage of the program and begin the development phase which is in progress as of the date of this report, and which is expected to draw on the experience of an industrial partner. As part of the industrial phase for the development of a new In Vitro Diagnostic (IVD) test, GENFIT intends to partner with a major diagnostic company with particular expertise in microRNA application to IVD, which would also include the development of the test within IVD regulatory requirements, as well as the manufacturing of the kits. ·Repurposing of nitazoxanide in fibrosis (TGFTX4 program) In the context of the TGFTX4 program, the Company has identified several potential drug candidates that show a strong anti-fibrotic activity in both cell-based assays and in vivo disease models. These results were obtained either by the therapeutic repurposing of compounds approved in another indication – allowing the Company to potentially shorten development time – or by a more classical hit- to-lead optimization of the Company’s proprietary compounds using a phenotypic screening approach in TGF beta-activated human hepatic stellate cells. Nitazoxanide, an antiparasitic drug with proven safety, was the subject of such repositioning studies seeking to repurpose it as a potent antifibrotic agent with efficacy demonstrated in two disease models of liver fibrosis, as presented at the 2017 International Liver Congress organized by EASL. On this basis, it is expected that a Phase 2a trial will be initiated in the United States to evaluate nitazoxanide in NASH with advanced fibrosis. ·TGFTX1 program (RORgt) As part of ambitious efforts to diversify and expand its development pipeline in the treatment of autoimmune, inflammatory and fibrotic diseases, the Company has conducted significant work over the last four years in the design and optimization of several novel RORgt (nuclear receptor) inverse agonists. The Company has recently launched pre-IND studies for a topically delivered treatment in mild to moderate psoriasis vulgaris and is evaluating the opportunity to forge a partnership with a company with an established dermatology franchise for both topically and orally administered drugs, to move certain of them forward. A research program is also underway at the date of this report to validate the benefit of proprietary molecules that inhibit the activity of the RORgt nuclear receptor identified in certain respiratory diseases. Here again, the Company is evaluating the possibilities of establishing a partnership with a specialist in these diseases in order to pursue development in this direction. Human Resources/Governance At the end of May, the Company announced the appointment of Pascal Prigent as Executive Vice President, Marketing and Commercial Development. Pascal Prigent brings to the Company a rich experience of more than 20 years in the pharmaceutical industry (Eli Lilly, GSK) on three continents (Europe, North America, Latin America). At the date of this report, Mr. Pascal Prigent is a member of the Company’s Executive Committee, made up of the following people: Chairman: Jean-François Mouney, Chairman and Chief Executive Officer of the Company; Dean Hum, Chief Operating Officer and Chief Scientific Officer; Nathalie Huitorel, Chief Financial Officer; Laurent Lannoo, Secretary General and Head of Legal Affairs; Jean-Christophe Marcoux, Chief Strategy Officer; Sophie Mégnien, Chief Medical Officer; Pascal Prigent, Executive Vice President, Marketing and Commercial Development. Main upcoming events: GENFIT is taking part in numerous scientific and investor events. The schedule is available in the “Media-Events” tab of the GENFIT website. APPENDICES GENFIT The Statements of Financial Position, Statements of Operations and Statements of Cash Flow of the Group were prepared in accordance International Financial Reporting Standards (IFRS). The limited review procedures on the consolidated financial statements have been performed. The half year consolidated financial statements for the period ended June 30, 2018 were approved by Board of Directors on September 21, 2018. The full consolidated financial statements as well as the notes to the consolidated financial statements for the period ended June 30, 2018 and the statutory auditor’s report on the consolidated financial statements are included in appendices of the Half Year Report at June 30, 2018 and available on the “Investors” page of the GENFIT website. Consolidated Statement of Financial Position Revenue and other income amounts to € 5,122 thousand at June 30, 2018 compared to €4,710 thousand for the same period in the previous year representing an increase of 8.7%. Revenues were stable at €64 thousand at June 30, 2018 compared with €65 thousand for the same period in the previous half year. Revenues and other income are mainly made up of the Research Tax Credit, government grants and other operating income, and amounted to €5,057 thousand in the first half 2018 compared to €4,645 thousand in the first half 2017, or an increase of 8.9%. This increase is mainly due to the Research Tax Credit which amounted to €4,981 thousand at June 30, 2018 compared to €4,533 thousand at June 30, 2017, due mainly to the increase in research and development expenses over the two periods in particular as a result of progress of the RESOLVE-IT Phase III clinical study (see in particular, (ii) “operating expenses and other operating income by destination” below). (ii) Operating expenses and other operating income by destination The tables below breaks down operating expenses by destination mainly into research and development expenses on the one hand, and general and administrative expenses on the other, for the half years ended June 30, 2017 and 2018. Operating expenses in the first half 2018 amounted to €36,677 thousand compared to €27,084 thousand in first half 2017, or a 35.4% increase. They include, in particular: research and development expenses , which include the wages and salaries paid to the research staff (€4,599 thousand at June 30, 2018 compared to €3,984 thousand at June 30, 2017), the cost of consumables and operational outsourcing (particularly clinical and pharmaceutical expenses representing €23,667 thousand at June 30, 2018 compared to €15,680 thousand at June 30, 2017) and expenses related to intellectual property. These research and development expenses amounted to €32,546 thousand at June 30, 2018 compared to €23,670 thousand at June 30, 2017, or 89% and 87% of operating expenses, respectively. The first half 2018 was marked, in comparison to the first half 2017, by the increase in operational outsourcing costs related to the Phase III RESOLVE-IT study. Other programs also generated operational outsourcing costs in the first half 2018 and first half 2017 but these amounts were less significant compared to those related to those relating to the development of elafibranor in NASH because they are in an earlier stage of R&D. Changes in personnel expenses for personnel assigned to research is mainly due to the evolution of the type of employee pro increases in compensation and increases in intellectual property expenses. General and administrative expenses , which include the costs of personnel not assigned to research (€1,712 thousand at June 30, 2018 compared to €1,664 thousand at June 30, 2017), and administrative and commercial costs. These general and administrative expenses amounted to €4,091 thousand in the first half 2018 compared with €3,448 thousand in the first half 2017, or 11% and 13% of operating expenses and other operating income, respectively. Changes in general and administrative expenses are mainly related to increase in communication expenses, payroll taxes and expenses related to maintenance of equipment at Company headquarters. (iii) Operating expenses and other operating income by type Broken down by type instead of by destination, operating expenses mainly included the following: Contracted research and development activities conducted by third parties Contracted research and development expenses conducted by third parties amounted to €22,747 thousand in the first half 2018 compared to €14,333 thousand in the first half 2017, corresponding to a 58.7% increase, which is mainly due to the progress of the Phase III study of elafibranor in NASH Employee expenses Employee expenses excluding share-based compensation amounted to €6,040 thousand in the first half 2018 compared to €5,519 thousand in the first half 2017, or a 9.4% increase, mainly due to changes in employee pro increases in compensation and an increase in the average number of employees between the two periods (130 vs 124). The amount recognized as share-based compensation (BSA, BSAAR, SO and AGA) free of any impact on cash flow increased from €129 thousand in the first half 2017 to €271 thousand in the first half 2018 The expenses recorded in the first half of 2018 relate to the SO and AGA plans put in place in December 2016, and to the BSA, SO and AGA plans put in place in 2017. The share of expenses related to the first half of 2017 related to SO and AGA plans put in place in December 2016. For further information, please refer to Note 6.19 of the Notes to the Consolidated Financial Statements included as appendices of the Half Year Report at June 30, 2018 and available on the “Investors” page on the GENFIT website. Other expenses Other expenses amount to €5,921 thousand in the first half 2018 compared to €5,190 thousand in the first half 2017. They include, in particular: “fees,” which include legal, audit, and accounting, the fees of various advisors (press relations, investor relations, communication, IT), external service providers (guard, security, reception and clinical trial management, IT), as well as the fees of some of its scientific advisers. This amount also includes intellectual property expenditures corresponding the fees incurred by the Company in connection with the registration and protection of its patents; expenses related to the rental, use, and maintenance of Group offices; donations to GENFIT’s endowment fund, “The NASH Education Program”, expenses related to business travel and conferences mainly for employees as well as the costs of participation in scientific, medical, financial, and business development conferences. These changes are mainly related to the increase in communication expenses, payroll taxes and expenses related to maintenance of equipment at Company headquarters. Financial income Financial income amounted to a loss of €2,828 thousand at June 30, 2018 compared to financial loss of €214 thousand in the first half 2017. This change is mainly due to interest payments related to the convertible bond (OCEANE) issued in October 2017. (i) Net income (loss) The first half 2018 resulted in a net loss of €34,512 thousand compared to a net loss of €22,615 thousand in the first half 2017. The net loss for the 2017 fiscal year amounted to €58,604 thousand. 2- Comments on the statement of financial position at June 30, 2018 At June 30, 2018, the total amount of the Group’s Statement of Financial Position amounts to €263,633 thousand compared to €293,183 thousand as of December 31, 2017. At June 30, 2018, the Group’s cash, cash equivalents and other financial assets amount to €238,767 thousand, compared to €274,581 thousand as of December 31, 2017. (i) Non current assets Non-current assets, which include trade and other receivables, goodwill and intangible, tangible, and financial assets, increase from €9,611 thousand as of December 31, 2017 to €10,217 thousand at June 30, 2018. This increase is mainly due to investments made in the first half 2018 (medical and IT equipment for clinical trials and renovations and scientific equipment for the laboratories). (ii) Current assets Current assets amount to €253,416 thousand at June 30, 2018 compared to €283,572 thousand as of December 31, 2017. Cash and cash equivalents went from €273,820 thousand at December 31, 2017 to €238,010 thousand at June 30, 2018, or a decrease of 13.1%. This is mainly placed in low risk, highly-liquid short term placements. The variation of trade and other receivables is justified mainly by the accounting of the amount estimated amount of the research tax credit for the first half 2018. Further information regarding the nature of these receivables is provided in note 6.7 of the Notes to the 2018 half year consolidated financial statements included in appendices of the Half Year Report at June 30, 2018 and available on the “Investors” page of the GENFIT website (see also chapter 8 of the Half Year Report at June 30, 2018 available on the “Investors” page of the GENFIT website). The variation of trade and other receivables corresponds to the increase in expenses recognized in advance related to current operating expenses. This increase follows the increase in operating expenses in the first half 2018. (iii) Shareh ol der s’ equi ty As of June 30, 2018, the amount of the Group’s shareholders’ equity totaled €69,996 thousand compared to €104,229 thousand as of December 31, 2017. The change in the Company’s shareholders’ equity is mainly due to the recognition of the half year loss reflecting the Company’s efforts in research and development, carrying out pre-clinical studies, and clinical studies related to elafibranor. The Notes to the 2018 half year consolidated financial statements included herein, as well as the Table of Changes in Shareholders’ Equity established under IFRS and included in appendices of the Half Year Report at June 30, 2018 available on the “Investors” page of the GENFIT website provide details on the change in the Company’s share capital and the Group’s shareholders’ equity, respectively. (iv) Non current liabilities This mainly concerns the following liabilities reaching maturity in more than one year: The convertible bond (OCEANE) issued in October 2017; conditional advances granted to GENFIT SA by Bpifrance for the purpose of financing the research programs detailed in Note 6.12.2.1 “Refundable and Conditional Advances” of the notes to the 2018 half year consolidated financial statements included in appendices of the Half Year Report at June 30, 2018 available on the “Investors” page of the GENFIT website ; and bank loans (for further detail, please refer to section note 6.12.2.2 “Bank loans” of the notes to the 2018 half year consolidated financial statements included in appendices of the Half Year Report at June 30, 2018 available on the “Investors” page of the GENFIT website). (v) Current liabilities This balance sheet item mainly includes the portion of the advances made to GENFIT SA by Bpifrance reaching maturity in less than one year, bank loans and trade and social security payables. The change in current liabilities is mainly due to the increase in operational subcontracting expenses. See also note 6.13 of the notes to the consolidated financial statements and included in appendices of the Half Year Report at June 30, 2018 available on the “Investors” page of the GENFIT website. ABOUT ELAFIBRANOR Elafibranor is GENFIT’s lead pipeline product. Elafibranor is an oral once-daily treatment, and a first-in- class drug acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH). Elafibranor is believed to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers. ABOUT NASH “NASH”, or nonalcoholic steatohepatitis, is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer. ABOUT PBC “PBC”, or Primary Biliary Cholangitis, is a chronic disease in which bile ducts in the liver are gradually destroyed. The damage to bile ducts can inhibit the liver’s ability to rid the body of toxins, and can lead to scarring of liver tissue known as cirrhosis. ABOUT GENFIT GENFIT is a biopharmaceutical company focused on the discovery and development of drug candidates in areas of high unmet medical needs corresponding to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT’s R&D efforts are focused on bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH – Nonalcoholic steatohepatitis) and more generally the gastro-intestinal arena. GENFIT’s approach combines novel treatments and biomarkers. Its lead proprietary compound, elafibranor, is currently in a Phase 3 study. With facilities in Lille and Paris, France, and Cambridge, MA (USA), the Company has approximately 130 employees. GENFIT is a public company listed in compartment B of Euronext’s regulated market in Paris (Euronext: GNFT - ISIN: FR0004163111). FORWARD LOOKING STATEMENT / DISCLAIMER This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous 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 biomarkers, progression of, and results of clinical data from, the RESOLVE-IT trial and the trial of elafibranor in PBC, review and approvals by regulatory authorities, such as the FDA or the EMA, regarding in particular, elafibranor in NASH and PBC, as well as other drug candidates in other indications and biomarkers candidates, the success of any inlicensing strategies, the Company’s continued ability to raise capital to fund its development, as well as those discussed or identified in the Company’s public filings with the AMF, including those listed under Section 4 “Main Risks and Uncertainties” of the Company’s 2016 Registration Document registered with the French Autorité des marchés financiers on April 27, 2018 under n° R.18-032, as updated by the 2018 Half Year Business and Financial Report which is available on GENFIT’s website ( ) and on the website of the AMF ( ). Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in GENFIT in any country. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede. CONTACT GENFIT | Jean-François Mouney – Chairman & CEO | +333 2016 4000 PRESS RELA TI O N S | Bruno Arabian | +33 6 8788 4726