Loading... (0%)
About liver disease

GENFIT: Reports Full-Year 2018 Financial Results: cash position of €207.2m as of 12.31.2018

GENFIT achieved significant development milestones in 2018:

  • Completed enrollment of interim analysis cohort for phase 3 RESOLVE-IT trial in NASH
  • Announced positive results in phase 2 trial of elafibranor in PBC
  • Entered into licensing agreement with LabCorp® for NASH diagnostic
  • Launched a U.S. phase 2 investigator-initiated trial of nitazoxanide in patients with NASH-induced fibrosis

Cash position of €207.2 million as of December 31, 2018, compared to €273.8 million as of December 31, 2017

Lille (France), Cambridge (Massachusetts, United States), February 4, 2019 – GENFIT (Euronext: GNFT – ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announces its annual financial results for 2018.

Jean-François Mouney, Chairman & CEO of GENFIT, commented: “The lead programs in our clinical and diagnostic pipeline, in particular the later-stage ones in NASH and PBC, have moved forward considerably and met our corporate 2018 milestones. We completed enrollment for the interim analysis cohort of our phase 3 RESOLVE-IT trial of elafibranor in NASH, achieved positive results in the phase 2 trial of elafibranor in PBC and accomplished significant milestones in the regulatory and commercial development of our biomarker program, leading to the signature of a licensing agreement with LabCorp® in early January this year. Our objective with this agreement is, in particular, to expand access to NIS4, GENFIT’s non-invasive in vitro diagnostic test, in order to identify NASH patients who should be considered for therapeutic intervention.  Our program to reposition nitazoxanide in liver fibrosis took shape with the launch of a U.S. phase 2 trial in patients with NASH induced fibrosis.  Additional pre-clinical research results completed in 2018 suggest that elafibranor is uniquely positioned as a backbone for combination therapies in NASH, including with our nitazoxanide program.

Finally, we believe our strong cash position allows GENFIT substantial flexibility as we prepare for a potential conditional marketing authorization for elafibranor in NASH in 2020.”

Detailed information and a summary of the consolidated financial statements are included in the attached PDF.

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. Elafibranor also presents a particularly interesting profile to potentially treat PBC, a rare liver disease.

About NASH

Nonalcoholic steatohepatitis, or NASH, is a liver disease characterized by an accumulation of fat, inflammation and degeneration of hepatocytes, and may ultimately lead to life-threatening conditions like cirrhosis, liver failure or liver cancer requiring liver transplant.

About PBC

Primary biliary cholangitis, or PBC, 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 late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there are considerable unmet medical needs, corresponding to a lack of approved treatments. GENFIT is a leader in the field of nuclear receptor-based drug discovery with a rich history and strong scientific heritage spanning almost two decades. Its most advanced drug candidate, elafibranor, is currently evaluated in pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for nonalcoholic steatohepatitis, or NASH. NASH is considered by regulatory authorities as a medical emergency because of its potentially severe consequences, although often asymptomatic until late stages, and because its prevalence is on the rise. Elafibranor has also obtained positive preliminary results in a Phase 2 clinical trial in primary biliary cholangitis (PBC), a severe chronic liver disease. As part of GENFIT’s comprehensive approach to clinical management of NASH patients, the company is also developing a new, non-invasive and easy-to-access blood-based in vitro diagnostic, or IVD, test to identify patients with NASH who may be appropriate candidates for drug therapy. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 150 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 safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, including its RESOLVE-IT Phase 3 trial, review and approvals by regulatory authorities, such as the FDA or the EMA, of its drug and diagnostic candidates, the success of any in-licensing 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) and as updated by the 2018 Half Year Business and Financial Report and available on the Investors page of GENFIT’s website. 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 | Investors

Naomi EICHENBAUM – Investor Relations | Tel: +1 (617) 714 5252 | investors@genfit.com

PRESS RELATIONS | Media

Hélène LAVIN – Press relations | Tel: +333 2016 4000 | helene.lavin@genfit.com

elit. elit. ultricies eleifend quis, massa