2017 HALF-YEAR RESULTS: CASH POSITION AT END OF PERIOD AT €126M AND SIGNIFICANT ADVANCES IN THE COMPANY’S PIPELINE

Lille (France), Cambridge (Massachusetts, United States), September 25, 2017 - 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 financial results for the 2017 half-year. It's 2017 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 2017 half-year consolidated financial statements are available on the "Investors" page of the GENFIT website.

Jean-François Mouney, Chairman & CEO of GENFIT, commented:

"Our 2017 half-year results mainly reflect the very significant acceleration of the RESOLVE-IT study of elafibranor in NASH, which will continue to expand considerably in the second half of 2017, given our objective to finish enrollment of approximately 1,000 patients towards the end of Q1 2018.

They also reflect the efforts and scientific advances realized in other important programs in our pipeline such as our NASH biomarkers program, which is entering its industrial development stage for a new in vitro diagnostic (IVD) test, after a feasibility stage that confirmed the competitiveness of the diagnostic performance of our signature to identify NASH patients to be treated.

In the first half of 2017 the first patients were enrolled in the phase 2 study evaluating the efficacy of elafibranor in PBC, a rare chronic liver disease in which a substantial number of patients have no treatment options under the currently available therapies - UDCA or OCA - either because of not reaching treatment goals or because of major side effects.

We are very enthusiastic for the potential of elafibranor in PBC: in previous clinical trials, our molecule has shown a good safety profile and demonstrated its ability to act on the main efficacy marker used in PBC studies. We expect the results of this Phase 2 study to be available in the second half of next year.

By the end of this year, we expect to have filed an application for authorization to launch a Phase 2 trial to evaluate the efficacy of nitazoxanide in liver fibrosis, currently prescribed as an anti-parasite, with proven safety of use, and whose antifibrotic potential was demonstrated in two pathological models presented by the Company last April at the International Liver Congress organized by EASL."

Main financial results:

Key aspects of the half-year 2017 results are:

• cash and cash equivalents of €126.3 million at June 30, 2017 (€152.3 million at December 31, 2016) in a context of a significant increase in current and projected operating expenses relating to the progression of the R&D portfolio;

• Operating income of €4.7 million (€3.7 million at June 30, 2016, essentially from the Research Tax Credit, which amounted to €4.5 million for the first half 2017 compared with €3 million in the preceding half year;

• Operating expenses of €27.1 million (€16.5 million at June 30, 2016) of which 87% represented R&D expenses. The increase in operating expenses is due :

  • mainly, to the increase in contracted research and development expenses (from €6.2 million at June 30, 2016 to €14.3 million at June 30, 2017) resulting from the progress of the R&D program pipeline, of which the majority relate to expenses for the Phase 3 study of elafibranor in NASH;

  • and to a lesser extent, an increase in other operating expenses (from €3.2 million at June 30, 2016 to €5.2 million at June 30, 2017) relating from the grant given by the Company to The NASH Education ProgramTM, endowment fund to carry out its educational outreach program on NASH, the increase in cost of external service providers for the management of clinical trials, and the increase in intellectual property expenses and fees.

• As a result of changes in revenues and expenses, a net loss of €22.6 million at June 30, 2017 (€12.7 million at June 30, 2016).

  The following table summarizes the Consolidated Statement of Operations under IFRS for the first half 2017, with comparative figures for the first half 2016.

  Half-year ended
  (in € thousands, except earnings per share data)	2016/06/30	2017/06/30
  Revenues and other income
  Revenue	151	65
  Other income	3 495	4 645
  Revenues and other income	3 647	4 710
  Operating expenses and other operating income (expenses)
  Research & development expenses	(12 323)	(23 670)
  General & administrative expenses	(4 166)	(3 448)
  Other operating income	0	(2)
  Other operating expenses	(1)	36
  Operating loss	(12 843)	(22 374)
  Financial revenue	278	341
  Financial expenses	(97)	(555)
  Financial loss	181	(214)
  Income tax	(0)	(26)
  Net loss	(12 662)	(22 615)

  The summary IFRS consolidated financial statements at June 30, 2017 as well as the management discussion of the results, are presented in the appendix at the end of this document.

  Main developments in the R&D pipeline programs during the first half 2017

  Elafibranor in NASH

  RESOLVE-IT Phase 3 study

  Enrollment of patients in the RESOLVE-IT Phase 3 study progressed actively during the course of the first half 2017.

  A 4 to 6 month delay in the initial enrollment calendar was observed during the first half, partly due to the increasing number of clinical trials now being launched in NASH, but is mainly attributable to the Company's desire to ensure enrollment quality in order to produce the most statistically robust clinical trial by ensuring 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 centers, enrollment of the first ~1000 patients to participate in the first phase of the trial is expected to be completed towards the end of Q1 2018.

  Early June, approximately one year after enrollment of the first patient in the RESOLVE-IT study, based on the initial tolerability and safety data, the Data Safety Monitoring Board (DSMB) issued a positive recommendation for the continuation of the RESOLVE-IT Phase 3 trial in NASH without any modifications.

  Progress in the disease awareness program

  In March 2017, the Company launched a disease awareness initiative through the endowment fund it founded in 2016, The NASH Education Program™, asserting its leadership in this area, and sparked an unprecedented wave of interest in the French media. This initiative is an important element in the awareness of all the stakeholders in NASH. It is also crucial in the context of enrollment for a little known and asymptomatic disease like NASH.

  This initiative, welcomed by a growing number of industry specialists and analysts, is planned to be launched in other countries. The Company announced that The NASH Education Program™ will organize the first International NASH Information Day in June 2018.

  Opportunities in combination therapy

  The Company is proactive in its combination therapy approaches in NASH, with elafibranor as the background therapy.

  To address the multifactoral nature of the disease and the multiple co-morbidities that NASH patients face, the Company is evaluating the following therapeutic potential of combinations with elafibranor:

• compounds from other GENFIT programs,

• already marketed drugs with complementary mechanisms of action,

• 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.

In this context, during the International Liver Congress (held on April 19-23, 2017 in Amsterdam, and organized by EASL), the Company presented preclinical data on the therapeutic synergies of elafibranor with an FXR agonist (exemplified with obeticholic acid). These results illustrate the potential for new combination treatments with elafibranor for the best possible care for NASH patients.