GENFIT : FILES REGISTRATION STATEMENT FOR PROPOSED INITIAL PUBLIC OFFERING IN THE UNITED STATES

FOR IMMEDIATE RELEASE

GENFIT FILES REGISTRATION STATEMENT FOR PROPOSED INITIAL PUBLIC OFFERING IN THE UNITED STATES

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,  today announced that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed initial public offering of its American Depositary Shares ("ADSs"), each representing one ordinary share, in the United States (the "U.S. Offering"), and a concurrent private placement of its ordinary shares in Europe (including France) and other countries outside of the United States and Canada (the "European Private Placement" and together with the U.S. Offering, the "Global Offering"). All securities to be sold in the Global Offering will be offered by GENFIT. The number of securities to be sold and the price range for the proposed Global Offering have not yet been determined. GENFIT has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol "GNFT."  The ordinary shares are listed on Euronext Paris under the symbol "GNFT."

SVB Leerink and Barclays are acting as joint global coordinators for the Global Offering and joint bookrunners for the U.S. Offering. Roth Capital Partners and H.C. Wainwright & Co. are acting as co-managers for the U.S. Offering. Bryan, Garnier & Co. Limited and Natixis are acting as joint bookrunners for the European Private Placement.

The securities referred to in this press release will be offered only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the Global Offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at [phone], ext. 6132, or by email at [e-mail]; or from Barclays Capital Inc., c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at [phone], or by email at [e-mail].

A registration statement relating to the securities referred to herein has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. The registration statement can be accessed by the public on the website of the SEC.

ABOUT GENFIT

GENFIT is a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases. GENFIT concentrates its R&D efforts in areas of high unmet medical needs corresponding to a lack of approved treatments. GENFIT's lead proprietary compound, elafibranor, is a drug candidate currently being evaluated in one of the most advanced Phase 3 studies worldwide ("RESOLVE-IT") in nonalcoholic steatohepatitis ("NASH"), considered by regulatory authorities as a medical emergency because it is silent, with potentially severe consequences, and with a prevalence 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 its comprehensive approach to clinical management of NASH patients, GENFIT is conducting an ambitious discovery and development program aimed at providing patients and physicians with a blood-based test for the diagnosis of NASH, i.e. non-invasive and easy-to-access. 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).

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, and the Company's continued ability to raise capital to fund its development, including as part of the proposed Global Offering, 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). 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.

No communication or information relating to the Global Offering by GENFIT may be transmitted to the public in a country where there is a registration obligation or where an approval is required. The issuance or the subscription of the shares of the Company may be subject to legal and regulatory restrictions in certain jurisdictions; none of GENFIT and the banks involved in the Global Offering assumes any liability in connection with the breach by any person of such restrictions.

This press release is an advertisement and not a prospectus within the meaning of Directive 2003/71/EC of the European Parliament and the Council of 4 November 2003 as amended or superseded, as implemented in each member state of the European Economic Area (the "Prospectus Directive").

This press release is not an offer to the public, an offer to subscribe or designed to solicit interest for purposes of an offer to the public in any jurisdiction, including France.

The shares of the Company will be offered only by way of a private placement in France and/or outside France (excluding the United States of America) to persons referred to in Article L.411-2-II of the French monetary and financial code (code monétaire et financier).

European Economic Area

With respect to the Member States of the European Economic Area which have implemented the Prospectus Directive (the "Relevant Member States"), no action has been undertaken or will be undertaken to make an offer to the public of the shares of the Company requiring a publication of a prospectus in any Relevant Member State. As a result, the shares of the Company may only be offered in Relevant Member States:

1. to any legal entity which is a qualified investor as defined in the Prospectus Directive;
2. to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive); or
3. in any other circumstances falling within Article 3(2) of the Prospectus Directive.

For the purposes of this paragraph, (i) the expression "offer to the public of shares of the Company" in any Relevant Member States, means any communication, to individuals or legal entities, in any form and by any means, of sufficient information on the terms and conditions of the offering and on the shares of the Company to be offered, thereby enabling an investor to decide to purchase or subscribe for the shares of the Company, as the same may be varied in that Member State.

These selling restrictions with respect to Relevant Member States apply in addition to any other selling restrictions which may be applicable in the Relevant Member States who have implemented the Prospectus Directive.

France

The shares of the Company in the context of the Global Offering will not be offered or sold or cause to be offered or sold, directly or indirectly, to the public in France. Any offer or sale of the shares of the Company and distribution of any offering material relating to the shares of the Company have been and will be made in France only to (a) persons providing investment services relating to portfolio management for the account of third parties (personnes fournissant le service d'investissement de gestion de portefeuille pour compte de tiers), and/or (b) qualified investors (investisseurs qualifiés) and/or a restricted circle of investors acting for their own account, as defined in, and in accordance with, Articles L.411-1, L.411-2 and D.411-1 of the French monetary and financial code (code monétaire et financier).

United Kingdom

This press release is addressed only (i) to persons located outside the United Kingdom, (ii) to investment professionals as defined in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), (iii) to people designated by Article 49(2) (a) to (d) of the Order or (iv) to any other person to whom this press release could be addressed pursuant to applicable law (the persons mentioned in paragraphs (i), (ii), (iii) and (iv) all deemed relevant persons ("Relevant Persons"). The shares of the Company sold in the context of the Global Offering are intended only for Relevant Persons and any invitation, offer of contract related to the subscription, tender, or acquisition of the shares of the Company in the context of the Global Offering may be addressed and/or concluded only with Relevant Persons. All persons other than Relevant Persons must abstain from using or relying on this document and all information contained therein.

This press release is not a prospectus which has been approved by the Financial Services Authority or any other United Kingdom regulatory authority for the purposes of Section 85 of the Order.

CONTACT

GENFIT | Investors

Naomi EICHENBAUM - Investor Relations | Tel: [phone] | [e-mail]

PRESS RELATIONS | Media

Hélène LAVIN - Press relations | Tel: [phone] | [e-mail]  

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | [phone] | www.genfit.com       

2019.02.27 GENFIT EN Public Filing

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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: GENFIT via Globenewswire