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About liver disease

GENFIT announces its upcoming participation in a number of investor and NASH-specific events over the next two months

Lille (France), Cambridge (Massachusetts, United States), August 31, 2018 – GENFIT (Euronext: GNFT – ISIN: FR0004163111), is a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases today announces its participation in numerous investor healthcare conferences both in Europe and the United States.

NASH is a fast evolving sector with numerous ongoing programs led by prominent pharmaceutical and biotechnology companies, all seeking to address the significant unmet medical need and growing burden on the healthcare system caused by this disease. Upcoming clinical milestones put NASH in the spotlight among the stakeholders which include the scientific community, media and investors.

Among those milestones, three programs (GENFIT, GILEAD and INTERCEPT PHARMACEUTICALS) have achieved full patient enrollment (Subpart H) for their on-going phase 3 trial in NASH, and should announce top-line results as early as next year that could lead to the first FDA- and EMA-approved drugs in the NASH space.

Of these most advanced molecules, GENFIT’s elafibranor is the only drug-candidate that has been able to show in a Phase 2b trial (Ratziu et al., Gastroenterology, 2016) a combination of:

  • Efficacy on “NASH resolution without worsening of fibrosis” (26% vs 5%; p-value 0,02):
    • biopsy-based regulatory approved endpoint for phase 3 clinical trials
    • based on a strong rationale, as reducing hepatocellular ballooning and inflammation is known to be correlated with fibrosis improvement

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  • Beneficial cardiovascular profile (LDL, TG, HDL, insulin resistance)
  • Clean safety and tolerability

In addition, new data releases from early phase (2a, 2b) clinical trials in NASH from companies like MADRIGAL and GALMED show that “resolving NASH” is a top priority for the whole NASH field.

Investors attending major European and American financial events over the next two months will be able to meet with GENFIT management, in a context characterized by upcoming data from clinical trials evaluating elafibranor in PBC (phase 2a) and NASH (phase 3).

UNITED STATES

  • Rodman & Renshaw Global Investment Conference
    September 4-6, 2018 – New York, NY, United States
  • Wells Fargo Healthcare conference
    September 5-6, 2018 – Boston, MA, United-States
  • Morgan Stanley Global Healthcare Conference
    September 12-14, 2018 – New York, NY, United States
  • GENFIT will also be taking part in a collaborative effort to build a consensus around outcomes set for NASH clinical trials. This initiative called Core NASH (Core Outcomes in Nonalcoholic Steatohepatitis) is led by the Center for Medical Technology Policy (CMTP) in partnership with:
    • Obesity Action Coalition (OAC), a non-profit organization;
    • The Liver Forum, a public/private partnership;
    • a number of companies developing molecules to treat NASH, of which GENFIT.

This list is non-exhaustive, and GENFIT will also be participating in other NASH-dedicated banking events in October in NYC, playing a key role in expert panels, and presenting its vision about the future of NASH.

EUROPE

  • Portzamparc Seminar
    September 6, 2018 – Paris, France
  • Goldman Sachs European Medtech/Services Conference
    September 7, 2018 – London, UK
  • Bank of America Merrill Lynch Global Healthcare conference
    September 11-14, 2018 – London, UK
  • European Large and Midcap Event
    October 8-9, 2018 – Paris, France
  • Morgan Stanley Biotech Bus Tour
    October 19, 2018 – Paris, France
  • NASH Summit Europe
    October 22-24, 2018 – Frankfurt, Germany

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) and Primary Biliary Cholangitis (PBC). Elafibranor is believed to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers. Elafibranor also presents a particularly interesting profile to potentially treat PBC, a rare liver disease.

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 discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases. GENFIT’s concentrates its R&D efforts in areas of high unmet medical needs corresponding to a lack of approved treatments. GENFIT’s lead proprietary compound, elafibranor, is a drug candidate currently being evaluated in one of the most advanced Phase 3 studies worldwide (“RESOLVE-IT”) in nonalcoholic steatohepatitis (NASH), considered by regulatory authorities as a medical emergency because it is silent, with potentially severe consequences, and with a prevalence on the rise. It is also evaluated in a Phase 2 study in Primary Biliary Cholangitis (PBC), a rare liver disease. As part of its comprehensive approach to clinical management of NASH patients, GENFIT is conducting an ambitious discovery and development program aimed at providing patients and physicians with a blood-based test for the diagnosis of NASH, i.e. non-invasive and easy-to-access. 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). www.genfit.com

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 in Section 4 “Main Risks and Uncertainties” of the Company’s 2017 Registration Document registered with the French Autorité des marchés financiers on April 27, 2018 under n° R.18-032, which is available on GENFIT’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org). 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 RELATIONS| Bruno Arabian | Ulysse Communication | +336 8788 4726

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