GENFIT

Regulatory Filings • Apr 14, 2014

www.genfit.com

GENFIT: THERAPEUTIC POTENTIAL OF GFT505 WIDENED TO NON-HEPATIC FIBROTIC DISEASES; NEW INSIGHTS ON ITS ANTI-FIBROTIC MECHANISM OF ACTION

• The therapeutic objective of GFT505 is to treat NASH in order to block its evolution to cirrhosis and associated complications.
• The results obtained to date demonstrate the anti-fibrotic effects of GFT505, that potentiate the therapeutic potential of GFT505 to treat NASH patients with advanced fibrosis.
• New studies widen the therapeutic potential of GFT505 to chronic inflammatory intestinal diseases, in particular Crohn's disease.

Lille (France), Boston (Massachusetts, United States), April 14, 2014 – GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, announces new data that illustrate the anti-fibrotic properties of GFT505 in a non-liver model of fibrotic disease and provide new insights on its anti-fibrotic mechanism of action. This data was presented on Saturday 12 April in London at the "breakfast workshop" organized by Genfit during the EASL (The International Liver Congress 2014).

The primary clinical objective of GFT505 is to treat NASH to eliminate the underlying cause of fibrosis and avoid evolution to cirrhosis and its complications. In all disease models, GFT505 not only treats NASH but also strongly reduces associated fibrosis, suggesting favorable direct anti-fibrotic effects. Accordingly, in the CCl⁴ chemically induced liver fibrosis model, GFT505 can prevent, block and reverse established fibrosis, thus favoring liver regeneration.

Chronic inflammatory diseases induce a process of pro-fibrotic scarring that can ultimately lead to organ failure. Although fibrotic diseases collectively show a high morbidity and mortality, there is currently no approved pure anti-fibrotic product which is able to treat fibrosis in a chronically injured organ.

New studies highlight the efficacy of GFT505 in a model of chronic bowel inflammation that is widely used to identify new treatments for Crohn's disease (DSS (dextran sodium sulfate)-induced chronic colitis). The results clearly show that oral treatment with GFT505 protects the intestine from inflammatory injury and reduces the associated fibrosis.

Fibrotic diseases are characterized by the proliferation and activation of specialized fibrosis-producing cells: fibroblasts/myofibroblasts. In vitro data show that GFT505 inhibits both proliferation induced by PDGF (Platelet-Derived Growth Factor) and activation induced by TGFβ1 (Transforming Growth Factor) in liver fibroblasts (hepatic stellate cells). Complementary in vitro studies show that GFT505 acts as an inhibitor of a group of structurally related Receptor Tyrosine Kinases (RTKs) known to be involved in fibrotic mechanisms.

Dr. Dean W. Hum, CSO of Genfit, declared: "Taken together, this data on the anti-fibrotic effects of GFT505 further strengthens its positioning as a first-line drug for the treatment of NASH patients, including those with the most advanced disease. Moreover, these findings widen the therapeutic potential of GFT505 to include

other chronic fibrotic liver and gastrointestinal diseases. In particular, GENFIT is considering the possibility of launching a Phase 2 proof-of-concept study in Crohn's disease."

About GENFIT:

GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in therapeutic fields linked to cardiometabolic disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, inflammatory diseases…). GENFIT uses a multi-pronged approach based on early diagnosis, preventive solutions, and therapeutic treatments and advances therapeutic research programs, either independently or in partnership with leading pharmaceutical companies, including Sanofi, to address these major public health concerns and their unmet medical needs.

GENFIT's research programs have resulted in the creation of a rich and diversified pipeline of drug candidates at different stages of development, including GENFIT's lead proprietary compound, GFT505 that is currently in Phase IIb.

With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 80 employees. GENFIT is a public company listed on the Alternext trading market by Euronext™ Paris (Alternext: ALGFT; ISIN: FR0004163111). www.genfit.com

Contacts:

GENFIT

Jean-François Mouney – CEO & Chairman of the Management Board Ph. +333 2016 4000

MILESTONES – Press Relations

Bruno Arabian Ph. +331 7544 8740 / +336 8788 4726 – barabian@milestones.fr