UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of report: May 14, 2019
Commission File Number: 001-38844
GENFIT S.A.
(Translation of registrant’s name into English)
Parc Eurasanté
885, avenue Eugène Avinée
59120 Loos, France
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Explanatory Note
General Meeting
Genfit S.A. (the “Company”) will hold its Ordinary Shareholders’ Meeting (the “Meeting”) on June 13, 2019 beginning at 2:30 p.m. CET at the Faculty of Pharmaceutical and Biological Sciences of Lille, located Parc Eurasanté, 3 rue du Professeur Laguesse in Lille (59000).
The following documents regarding the Company’s Meeting, which are attached as exhibits hereto, are incorporated by reference herein. Additional information regarding the Meeting is available to shareholders on the Company’s website, in the documentation center (http://www.genfit.com/investors/documentation-center/).
Press Release
On May 14, 2019, the Company issued a press release announcing the positive 36-month Data Safety Monitoring Board recommendation for the continuation of the Phase 3 RESOLVE-IT Study of elafibranor in NASH, attached as an exhibit hereto, and incorporated by reference herein.
EXHIBIT LIST
| Exhibit | Description | |
| 99.1 | Notice of Shareholders’ Meeting of Genfit S.A., including Agenda | |
| 99.2 | Amended Notice of Shareholders’ Meeting of Genfit S.A. | |
| 99.3 | Press Release dated May 14, 2019 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| GENFIT S.A. | ||||
| Date: May 14, 2019 | By: | /s/ Jean-François Mouney | ||
| Name: Jean-François Mouney | ||||
| Title: Chairman and Chief Executive Officer | ||||
Exhibit 99.1
May 8, 2019 FRENCH OFFICIAL LEGAL ANNOUNCEMENT PUBLICATION «BALO» Bulletin N°55
This document has been translated in English for information only. In the event of any differences between the French text and the English text, the French language version shall supersede.
SHAREHOLDERS' AND UNITHOLDERS' MEETINGS
GENFIT
French public limited company (Société
Anonyme)
governed by a Board of Directors
with share capital of 9,707,855.25 euros
Registered Office: 885 avenue Eugène Avinée, 59120 Loos
424 341 907 R.C.S. Lille Métropole
(the “Company”)
Notice of meeting serving as convocation
Ladies and Gentlemen, the fellow shareholders of GENFIT are convened to attend an Ordinary Shareholders’ Meeting at the Faculty of Pharmaceutical and Biological Sciences of Lille, located Parc Eurasanté, 3 rue du Professeur Laguesse in Lille (59000), on June 13, 2019 at 2:30 pm, to deliberate on the following agenda:
AGENDA
Ordinary Shareholders’ Meeting
| - | Presentation of the Board of Directors’ management report on the Company's activities and on the financial statements for the year ended on December 31, 2018 and the Statutory Auditors' general report on the accounts for the year ended on December 31, 2018; |
| - | Presentation of the consolidated management report by the Board of Directors, and reading of the Statutory Auditors' general report on the consolidated financial statements for the year ended on December 31, 2018; |
| - | Presentation of the Board of Directors’ corporate governance report; |
| - | Approval of the annual financial statements for the year ended on December 31, 2018 (Resolution n°1); |
| - | Approval of the consolidated annual financial statements for the year ended on December 31, 2018 (Resolution n°2); |
| - | Allocation of the results for the year ended on December 31, 2018 (Resolution n°3); |
| - | Reading of the Statutory Auditors' special report on the regulated agreements within the meaning of article L.225-38 et seq of the French Code de commerce and approval of the regulated agreements referred to in the Statutory Auditors' special report (Resolutions n°4-11); |
| - | Reading of the Board of Directors’ special report on the options to subscribe or purchase Company’s shares in accordance with article L. 225-184 of the French Code de commerce; |
| - | Reading of the Board of Directors’ special report on the granting of free shares in accordance with article L. 225-197-4 of the French Code de commerce; |
| - | Reading of the table summarizing the delegations of authority and powers granted by the Shareholders’ Meeting to the Board of Directors in respect of capital increases, in accordance with articles L. 225-129-1 et seq. of the French Code de commerce; |
| - | Reading of the Board of Directors’ supplemental report on the use of delegations of powers granted by the Shareholders’ Meeting, in accordance with article R. 225-116 of the French Code de commerce; |
| - | Determination of attendance fees to be allocated to members of the Board of Directors (Resolution n°12); |
| - | Approval of the fixed, variable and extraordinary components of overall compensation and benefits of all kind that may be paid or granted and paid or granted to Jean-François MOUNEY, President and Chief Executive Officer for the 2018 financial year (Resolution n°13); |
| - | Approval of principles and criteria for determining, allocating and granting of the fixed, variable and extraordinary components of overall compensation and benefits of all kind that may be granted to the President and Chief Executive Officer for the 2019 fiscal year (Resolution n°14); |
| - | Powers to carry out formalities (Resolution n°15). |
DRAFT RESOLUTIONS
Ordinary Shareholders’ Meeting
First Resolution - Approval of the annual financial statements for the year ended on December 31, 2018
The Shareholders’ Meeting, deciding under the quorum and majority requirements for shareholders’ meetings, having reviewed the Board of Directors report, and on the Company's annual financial statements and having reviewed the Statutory Auditors' report for the year ended on December 31, 2018, approves such financial statements as presented prepared according to French standards and in accordance with the French Code de commerce , which show a net loss of (75,733,978) euros.
The Shareholders’ Meeting also approves the operations reflected in these annual financial statements or summarized in these reports.
Under articles 223 quater and 223 quinquies of the French Code général des impôts, the Shareholders’ Meeting notes that there are no expenditures or charges deductible from the Company's taxable income as referred to in article 39.4 of the French Code général des impôts.
After having deliberated on this matter, the Shareholders’ Meeting gives to the members of the Board of Directors and the Statutory Auditors, full and unconditional discharge from their duties for said year.
Second Resolution - Approval of the consolidated financial statements for the year ended on December 31, 2018
The Shareholders’ Meeting, deciding under the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Board of Directors report, and having reviewed the Statutory Auditors' report for the year ended on December 31, 2018, approves such consolidated annual financial statements as presented, prepared according to the new standards and amendments to the international financial reporting standards and the IFRS accounting standards, which show a loss of (79,520,572) euros, as well as the operations reflected in these statements or summarized in these reports.
After having deliberated on this matter, the Shareholders’ Meeting gives to the members Board of Directors and to the Statutory Auditors, full and unconditional discharge from their duties for said year.
Third Resolution - Allocation of the results for the year ended on December 31, 2018
The Shareholders’ Meeting, deciding under the quorum and majority requirements for ordinary shareholders’ meetings, approves the proposal of the Board of Directors regarding the allocation of the results for the financial year 2018 and thus decides to allocate the loss for the year ended on December 31, 2018 as follows:
| ORIGIN | ||
| Deficit for the year ended on December 31, 2018 | €(75,733,978) | |
| ALLOCATION | ||
| Allocation to the item "Retained earnings", | ||
| For a total of | €(75,733,978) | |
This thus brings the retained earnings from € (165,857,461) to €(241,591,439)
The Shareholders’ Meeting acknowledges, in accordance with article 243 bis of the French Code général des impôts, that so far there has been no distribution of dividends during the previous three financial years.
Fourth Resolution – Special report of the Statutory Auditors on regulated agreements – Agreement previously authorized and entered into and which the execution continued during the fiscal year
After having deliberated on this matter, the Shareholders’ Meeting, deciding under the quorum and majority requirements for ordinary shareholders’ meetings and, having reviewed the report prepared by the Statutory Auditors pursuant to articles L.225-38 and L.225-40 of the French Code de commerce, on the agreement authorized and previously entered into and for which performance continued during the course of the previous financial year, approves the report relating to the agreement.
Fifth Resolution - Special report of the Statutory Auditors on regulated agreements – Agreement entered into between the Company and Mr. Jean-François Mouney, Chairman and Chief Executive Office of the Company
The Shareholders’ Meeting, acting in accordance with the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Statutory Auditors’ report prepared in accordance with articles L.225-38 and L. 225-40 of the French Code de commerce regarding the agreement entered into between the Company and Mr. Jean-François Mouney, approves this report as it regards this agreement. .
Sixth Resolution - Special report of the Statutory Auditors on regulated agreements – Agreement entered into between the Company and Mr. Xavier Guille des Buttes
The Shareholders’ Meeting, acting in accordance with the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Statutory Auditors’ report prepared in accordance with articles L.225-38 and L. 225-40 of the French Code de commerce regarding the agreement entered into between the Company and Mr. Xavier Guille des Buttes, approves this report as it regards this agreement.
Seventh Resolution - Special report of the Statutory Auditors on regulated agreements – Agreement entered into between the Company and Biotech Avenir
The Shareholders’ Meeting, acting in accordance with the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Statutory Auditors’ report prepared in accordance with articles L.225-38 and L. 225-40 of the French Code de commerce regarding the agreement entered into between the Company and Biotech Avenir, approves this report as it regards this agreement.
Eighth Resolution - Special report of the Statutory Auditors on regulated agreements – Agreement entered into between the Company and Mr. Frédéric Desdouits,
The Shareholders’ Meeting, acting in accordance with the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Statutory Auditors’ report prepared in accordance with articles L.225-38 and L. 225-40 of the French Code de commerce regarding the agreement entered into between the Company and Mr. Frédéric Desdouits Mouney, approves this report as it regards this agreement.
Ninth Resolution - Special report of the Statutory Auditors on regulated agreements – Agreement entered into between the Company and Ms. Catherine Larue
The Shareholders’ Meeting, acting in accordance with the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Statutory Auditors’ report prepared in accordance with articles L.225-38 and L. 225-40 of the French Code de commerce regarding the agreement entered into between the Company and Ms. Catherine Larue, approves this report as it regards this agreement.
Tenth Resolution - Special report of the Statutory Auditors on regulated agreements – Agreement entered into between the Company and Ms. Anne-Hélène Monsellato
The Shareholders’ Meeting, acting in accordance with the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Statutory Auditors’ report prepared in accordance with articles L.225-38 and L. 225-40 of the French Code de commerce regarding the agreement entered into between the Company and Ms. Anne-Hélène Monsellato, approves this report as it regards this agreement.
Eleventh Resolution - Special report of the Statutory Auditors on regulated agreements – Agreement entered into between the Company and Mr. Philippe Moons
The Shareholders’ Meeting, acting in accordance with the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Statutory Auditors’ report prepared in accordance with articles L.225-38 and L. 225-40 of the French Code de commerce regarding the agreement entered into between the Company and Mr. Philippe Moons, approves this report as it regards this agreement.
Twelfth Resolution – Determination of attendance fees to be allocated to members of the Board of Directors
The Shareholders’ Meeting, deciding under the quorum and majority requirements for ordinary shareholders’ meetings, having reviewed the Board of Directors report and the Nominations and Compensation Committee's report, decides to set at the maximum amount of six hundred thousand euros (€600,000) the amount of attendance fees granted to the Board of Directors for the period beginning at the start of the Company’s 2019 financial year (i.e., January 1, 2019) until the end of the 2019 financial year (i.e., December 31, 2019) as well as for any subsequent financial year until a new decision of the shareholders changes this decision, and leaves it up to the Board of Directors to distribute such amounts.
Thirteenth Resolution - Approval of the fixed, variable and extraordinary components of overall compensation and benefits of all kind that may be paid or granted and paid or granted to Jean-François MOUNEY, President and Chief Executive Officer for the 2018 financial year
Pursuant to articles, L.225-37-2, L.225-100 and L.225-102 of the French Code de commerce, the Shareholders’ Meeting, acting under the conditions of quorum and majority required for ordinary shareholders’ meetings, approves, the principles and criteria for determining, allocating and granting of the fixed, variable and extraordinary components of overall compensation and benefits of all kind paid for the preceding financial year or granted for the financial year 2018 to Mr. Jean-François MOUNEY as presented in paragraph 15.1.2 of the 2018 Registration Document including the corporate governance report of the Company as mentioned in article L.225-37-2 of the French Code de commerce attached to the report referred to in articles L. 225-100 and L. 255-102 of the French Code de commerce and paragraph 4(c) of the report of the Board of Directors to the Shareholders’ Meeting.
Fourteenth Resolution – Approval of principles and criteria for determining, allocating and granting of the fixed, variable and extraordinary components of overall compensation and benefits of all kind that may be granted to Jean-François MOUNEY, President and Chief Executive Officer of the Company for the 2019 financial year
The Shareholders’ Meeting, acting under the conditions of quorum and majority required for ordinary shareholders’ meetings, approves, in accordance with article L. 225-37-2 of the French Code de commerce, the principles and criteria for determining, allocating and granting of the fixed, variable and extraordinary components of overall compensation and benefits of all kind, according to his mandates, that may be granted to Jean-François MOUNEY for the 2019 financial year, as described in Schedule III to the Report of the Board of Directors to the Shareholders’ Meeting, completing the corporate governance report referred to in article L.225-37-2 of the French Code de commerce attached to the report referred to in articles L. 225-100 and L. 255-102 of the French Code de commerce.
Fifteenth Resolution – Powers to carry out formalities
The Shareholders’ Meeting grants full powers to the holder of an original, a copy or an extract of the minutes of this Shareholders’ Meeting, in its ordinary and extraordinary parts, for the purposes of fulfilling all legal formalities.
Preliminary formalities to complete in order to participate in this Shareholders’ Meeting
The shareholders’ meeting is composed of all the shareholders irrespectively of the number of shares they do own.
The shareholders, wishing to participate to the shareholders’ meeting, to be represented or to vote by correspondence, shall justify the ownership of their shares on the second business day preceding the shareholders’ meeting at 0:00 am, Paris time (which will be June, 11 2019, 0:00 am, Paris time) by registration of their shares in their name, in accordance with the conditions set forth in the article R.225-85 French Code de commerce.
Modalities to participate to the shareholders’ meeting
The shareholders would like to physically attend the shareholders’ meeting: for the shareholder who holds shares in registered form:
to arrive on the Shareholders’ Meeting day directly to the counter specifically dedicated to this purpose with an identity card.
request an admittance card:
| · | either at BNP Paribas Securities Services, Service Assemblées Générales – CTS Assemblés Générales – Les Grands Moulins de Pantin 9, rue du Débarcadère – 93761 Pantin Cedex, |
| · | or by requesting online on the secure platform VOTACCESS, via the access by the Planetshares website on the following address: https://planetshares.bnpparibas.com. |
The holder of pure registered shares (action inscrites au nominatif pur) will have to connect on the Planetshares website with his usual access codes.
The holder of administered registered shares (actions inscrites au nominatf administré) will have to log on the Planetshares website using his username, which is to be mentioned on the upper right of the hardcopy of his voting form. In case the shareholder is not in possession of his username and/or password, he may contact the numbers 01 57 43 02 30 (from France) or +33 1 57 43 02 30 (from abroad), at his disposal or via the contact form available at Planetshares https://planetshares.bnpparibas.com.
After being logged in, the holder of registered shares shall follow the guidelines on his screen in order to access the VOTACCESS website and request for an admission card.
| - | for the shareholder which shares are in the bearer form (actions inscrites au porteur): |
request from the financial intermediary, which manages his share account, that an admission card will be sent to him.
If the financial intermediary, which manages his share account, is connected to the website VOTACCESS, the shareholder can also request an admission card by electronic means according to the following terms:
After being identified on the internet portal of this financial intermediary with usual access code, he shall click on the icon, which appears on the line corresponding to the GENFIT shares and follow the guidelines given on his screen in order to access to the VOTACCESS website and ask for an admission card
Shareholders who are not physically present at the shareholders’
meeting and wishing to vote by correspondence or be represented, by giving the power to the President of the shareholders’
meeting or any other person, may:
| - | for the shareholder which shares are in registered form: |
| · | either re-send a unique voting form by correspondence or by power of attorney, which will be addressed with the convocation to the following address: BNP Paribas Securities Services, Service Assemblées Générales – CTS Assemblées Générales – Les Grands Moulins de Pantin 9, rue du Débarcadère – 93761 Pantin Cedex. |
The appointments or revocations of the representatives expressed in paper form will be received at least three calendar days before the shareholders’ meeting.
| · | either transmit his oral voting instructions, and designate or revoke a representative by the Internet before the shareholders’ meeting, on the VOTACCESS website in the conditions described below: |
The holder of share in pure or administered registered form, wishing to vote by Internet, will access to the website VOTACCESS via the website Planetshares, which address is the following: https://planetshares.bnpparibas.com.
The holder of shares in pure registered form shall connect to the website Planetshares by using its usual access codes. The holder of shares in administered registered form shall connect to the website Planetshares by using his ID number on the upper right of his voting paper form. In case the shareholder is not in possession of his username and/or password any more, he can contact the numbers 01 57 43 02 30 (from France) or +33 1 57 43 02 30 (from abroad) at his disposal or proceed via a contact form.
After being logged in, the holder of shares in registered form shall follow the guidelines on his screen in order to access the website VOTACCESS and vote or designate or revoke a representative.
| - | for the shareholder which shares are in the bearer form: |
request for the unique form of vote by correspondence or by power of attorney from the financial intermediary which manages the securities as from the date of which the general meeting has been convened. Such unique form shall be accompanied by a participation certificate delivered by a financial intermediary and addressed to: BNP Paribas Securities – CTS Assemblées Générales – Les Grands Moulins de Pantin 9, rue du Débarcadaère – 93761 Pantin Cedex.
To be taken into account, the forms of vote by correspondence shall be received by the issuer or the BNP Paribas Securities Services General Meetings department, at the latest, three calendar days (i.e., June 10, 2019) before the closing of the general meeting.
If the financial intermediary is connected to the website VOTACCESS, the shareholder shall identify himself on the internet portal of his account holder establishment with his usual access codes. He should then click on the icon appearing on the corresponding line of his shares and follow the guidelines written on the screen in order to access to the VOTACCESS website and vote or appoint or revoke a representative.
If the account holder establishment of the shareholder is not connected to the website VOTACCESS, in accordance with the provisions of article R.225-79 French Code de commerce the notice of the representative appointment and revocation can also be performed by electronic means, according to the following terms:
| - | the shareholder shall send an email to the address: paris.bp2s.france.ctsmandats@bnpparibas.com. |
This email shall contain the following information: name of the involved issuer, date of shareholders’ meeting, name, surname, address, banking references of the shareholder and the name, surname and if possible the address of the representative.
| - | the shareholder shall request from his financial intermediary which manage his share accounts to send a written confirmation to the service Assemblées Générales of BNP Paribas Securities Services – CTS Assemblées Générales – Les Grands Moulins de Pantin 9, rue du Débarcadère – 93761 Pantin Cedex. |
Only the designations or revocations’ notifications of the representatives shall be addressed to the above mentioned electronic address, any other request or notification about another matter will not be taken into account.
In order for the designations or revocations’ notifications of representative mandates expressed by electronic means to be validly taken into account, the confirmations shall be received at the latest the day before the general meeting, at 3:00 pm (Paris time).
The website VOTACCESS will be open from May 27, 2019.
The possibility to vote by internet before the General Meeting will end on the day preceding the general meeting i.e., June 12, 2019, at 3 pm, Paris time.
However, in order to avoid any overcrowding of the VOTACCESS website, it is recommended to shareholders not to wait the day preceding the shareholders’ meeting to vote.
Written questions
In accordance with article R.225-84 of French Code de commerce, each shareholder has the possibility to send to the Board of Directors, which should answer during the meeting, the written questions of his choice.
The questions shall be sent by registered letter with acknowledgement of receipt at the following address GENFIT, Service Financier, Parc Eurasanté, 885 avenue Eugène Avinée, 59120 LOOS or by email to the following address: investors@genfit.com.
This mailing shall be realised at the latest the fourth business day preceding the date of the shareholders’ meeting.
Rights to shareholder information
All the documents and information set forth in article R.225-73-1 of the French Code de commerce shall be available on the issuer’s website: www.genfit.fr, as from the 21st day before the shareholders’ meeting, i.e., May, 23, 2019.
The Board of Directors
Exhibit 99.2
May 13, 2019 FRENCH OFFICIAL LEGAL ANNOUNCEMENT PUBLICATION «BALO» Bulletin N°57
This document has been translated in English for information only. In the event of any differences between the French text and the English text, the French language version shall supersede.
SHAREHOLDERS' AND UNITHOLDERS' MEETINGS
GENFIT
French public limited company (Société
Anonyme)
governed by a Board of Directors
with share capital of 9,707,855.25 euros
Registered Office: 885 avenue Eugène Avinée, 59120 Loos
424 341 907 R.C.S. Lille Métropole
(the “Company”)
Meeting notice serving as convening notice
ORDINARY SHAREHOLDERS MEETING OF JUNE 13, 2019
Notice correcting the meeting notice serving as the convening notice published on May 8, 2019 in the French Official Legal Publication for Announcements (“BALO”) n°55
In the aforementioned notice, the fourth resolution should be read as follows:
Fourth Resolution – Special report of the Statutory Auditors on regulated agreements – Agreements previously authorized and entered into and for which the performance continued during the financial year
After having deliberated on this matter, the Shareholders’ Meeting, deciding under the quorum and majority requirements for ordinary shareholders’ meetings and, having reviewed the report prepared by the Statutory Auditors pursuant to articles L.225-38 and L.225-40 of the French Commerical Code on the agreements authorized and previously entered into and for which performance continued during the course of the previous financial year, approves the report relating to these agreements.
The Agenda and the other resolutions remain unchanged.
Exhibit 99.3
GENFIT: Positive 36-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH
| - | Data Safety Monitoring Board (DSMB) recommends the continuation of the RESOLVE-IT clinical trial without any modifications, based on the pre-planned review of safety data |
| - | Positive recommendation consistent with previous guidance, supporting favorable safety profile of Elafibranor |
Lille (France), Cambridge (Massachusetts, United States), May 14, 2019 – GENFIT (Euronext: GNFT – Nasdaq: GNFT) 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 the Data Safety Monitoring Board (DSMB) issued a new positive recommendation for the continuation, without any modifications, of the RESOLVE-IT Phase 3 trial evaluating elafibranor in NASH. This sixth planned review by the DSMB reiterates previous positive guidance and saw no safety concerns.
The 36-month positive DSMB safety review supports GENFIT’s positive momentum in continuing the RESOLVE-IT study. Top-line interim results, based on the primary endpoint of “NASH resolution without worsening of fibrosis”, are expected to be announced at the end of 2019. If positive, the interim data would support accelerated approval (Subpart H) from the U.S. Food and Drug Administration (FDA), and conditional approval from the European Medicines Agency (EMA), as early as 2020. Elafibranor is currently the only late-stage, Phase 3 therapy undergoing investigation for “NASH resolution without the worsening of fibrosis”. As such, elafibranor could be the first available therapy able to eliminate the underlying cause of NASH disease progression. Elafibranor has received fast track designation from the FDA for the treatment of NASH.
Dr Pascal Birman, Deputy Chief Medical Officer of GENFIT, commented: “This sixth positive DSMB review continues to support GENFIT’s development of elafibranor in NASH. NASH is considered a chronic condition and therefore a clean safety profile is crucial for any drug candidate aiming to address the unmet clinical needs related to this pathology. In addition, the safety profile gives us further confidence as we explore elafibranor in the clinical setting, specifically for pediatric NASH – a naïve patient population and a trial we expect to begin enrolling shortly – and PBC, a program we plan to move into a Phase 3 clinical trial later this year.”
| GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com | 1 |
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About elafibranor
Elafibranor is GENFIT’s lead pipeline product candidate. Elafibranor is an oral, once-daily, first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH). GENFIT believes, based on clinical results to date, that elafibranor has the potential to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers. Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a rare liver disease.
About RESOLVE-IT
RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. It is a multicenter, randomized, double-blind, placebo-controlled study with 2 arms. It is conducted under Subpart H (FDA) and conditional approval (EMA). Treatment duration until interim analysis for accelerated approval is 72 weeks.
About NASH
“NASH” 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 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 being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. 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 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 on the Nasdaq Global Select Market and in compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com
| GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com | 2 |
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FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995, with respect to GENFIT, including the continuation of its clinical trials in NASH. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown 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, review and approvals by regulatory authorities of its drug and diagnostic candidates and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the French Autorité des Marchés Financiers (“AMF”), including those listed in Section 4 “Main Risks and Uncertainties” of the Company’s 2018 Registration Document filed with the AMF 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 public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s final prospectus dated March 26, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
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
| GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com | 3 |