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About liver disease

GENFIT: First quarter 2016 financial information

(unaudited financial information prepared in accordance with IFRS)

› Cash, cash equivalents and current financial instruments amount to €102.8 million at March 31, 2016, strengthened in particular by the €49.6 million private placement with specialized  institutional investors
› Revenue for the first three months of 2016 reached €88 K
› Progression of the entire proprietary pipeline, including the most advanced programs, and new scientific and medical opportunities

Lille (France), Cambridge (Massachusetts, United States), April 26, 2016 – GENFIT (Euronext : GNFT – ISIN : FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announced its revenues for the first three months of 2016 and its cash position at March 31, 2016.

Cash position

At March 31, 2016, the cash, cash equivalents and current financial instruments of the Company amounted to €102.8 million against €69.5 million one year ago. This amount includes the funds received in the February 2016 private placement to specialized institutional investors, mainly in the United States.

Revenue

Revenue for the first three months of 2016 amounts to €88 K against €150 K for the same period in 2015.

Key events of the first quarter 2016

Notably, the first quarter saw the publication in Gastroenterology of the promising results of the Phase 2b GOLDEN-505 trial for Elafibranor in NASH and the enrollment of the first patient in the RESOLVE-IT study, the pivotal Phase 3 trial evaluating Elafibranor as a treatment for NASH.
During its R&D Day in March, the Company also announced its intention to launch, subject to approval of the relevant regulatory authorities, new clinical trials of Elafibranor in pediatric patients, in cirrhosis, and, in Primary Biliary Cholangitis (PBC), and presented the progress of the Company’s other programs (see below “Progress of proprietry programs”).

A €49.6 million private placement to specialized institutional investors, mainly in the United States, strengthened the cash position and increased the Company’s ability to finance, in particular, the costs of the RESOLVE-IT trial.

Jean-François Mouney, Chairman and Chief Executive Officer of GENFIT said: “The scientific and financial achievements of the past months are key for our Company, which has entered a new phase in its development. Our R&D Day and the importance given to the presentations of our proprietary programs at the International Liver Congress (ILC) organized by the EASL (European Association for the Study of the Liver) highlighted not only the progress and prospects of Elafibranor but also the progress made, in particular, by our diagnostic biomarkers in NASH and our anti-fibrosis programs.”

Progress of proprietary programs

During the first quarter, proprietary R&D activities progressed according to plan.

With respect to the Company’s three most advanced proprietary programs:

o Elafibranor: the first patient was enrolled in the Phase 3 RESOLVE-IT trial, testing Elafibranor administered in a 120mg daily dose in patients suffering from NASH (nonalcoholic steatohepatitis) presenting a NAS score equal to or greater than 4 with F2 or F3 fibrosis.

o BMGFT03 (Biomarkers in NASH): during its R&D Day and at the ILC, the Company presented the program’s rational, and in particular, the micro ribonucleic acids (miRNA) used in the Company’s innovative biomarkers using algorithms developed by the Company to determine which NASH patients to treat with Elafibranor or any other appropriate treatment.

o TGFTX4 (Research program for drug candidates in fibrotic diseases): the program’s process, repositionning strategy and the plan to launch a Phase 2 trial in molecules from the [French] pharmacopoeia were presented by the Company during the R&D Day.

Upcoming events in the second quarter 2016

o 1st International Workshop on NASH Biomarkers: April 29-30, 2016, Washington DC – USA

o 41th Deutsche Bank Annual Healthcare Conference: May 4-5, 2016, Boston – USA

o Gilbert Dupont 14th Healthcare Conference: May 10, 2016, Paris – France

o Bank of America Merrill Lynch Healthcare Conference: May 10-12, 2016, Las Vegas – USA

In addition, the Annual Shareholders’ Meeting will be held on June 21, 2016.

About Elafibranor:

Elafibranor (GFT505) 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 to treat 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 (GFT505), completed a Phase 2b study in NASH and is currently in a Phase 3 study. With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 100 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, results of clinical data from the RESOLVE-IT trial, review and approvals by regulatory authorities, such as the FDA or the EMA, regarding Elafibranor and biomarkers, 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 4.2 “Risk Factors” (“Facteurs de Risque”) of the Company’s Annual Financial Report for the year ended December 31, 2015, which is available on GENFIT’s website (www.genfit.com). 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 | Ph. +333 2016 4000
MILESTONES – Press Relations | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 – barabian@milestones.fr

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com

 

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