GENFIT: Publication of the 2018 Registration Document
Lille (France), Cambridge (Massachusetts, United States), February 27, 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, announces today the filing of its 2018 Registration Document with the Autorité des marchés financiers (AMF).
The French-language document is available to the public free of charge in accordance with applicable regulations and may be viewed at and downloaded from GENFIT’s website at the following address: www.genfit.com. The 2018 Registration Document is also available on the AMF website: www.amf-france.org
GENFIT’s 2018 Registration Document includes, in particular, the annual financial report, the annual Board of Directors’ management report, the Board of Directors’ report on corporate governance, the Statutory Auditors’ reports on annual and consolidated financial statements and the description of the fees paid to the Statutory Auditors.
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 being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for nonalcoholic steatohepatitis (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 obtained positive preliminary results in a Phase 2 clinical trial in primary biliary cholangitis, a severe chronic liver disease. As part of GENFIT’s comprehensive approach to clinical management of NASH patients, GENFIT 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, GENFIT 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 2018 Registration Document filed with the French Autorité des Marchés Financiers on February 27, 2019 under n° D.19-0078, 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.
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