Not for publication, release or distribution directly or indirectly in the United States of America, Canada, Australia or Japan. This press release is not an offer of securities, or a solicitation for purchase, subscription or sale of securities in the United States of America or in any other jurisdiction in which it would be unlawful to do so.
GENFIT LAUNCHES A SHARE CAPITAL INCREASE THROUGH PRIVATE PLACEMENT
Lille (France), Cambridge (Massachusetts, United States), October 5 th , 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 (the " Company "), announces today the launch of a capital increase through a private placement (the " Private Placement ") reserved to the categories of institutional investors described below.
This Private Placement is the first step of a c. EUR 75-80 million fundraising which is intended to provide the Company with additional means of funding its strategy, and more specifically, to:
continue the development of the Phase III clinical program for Elafibranor in NASH, in particular, through the RESOLVE-IT pivotal study;
continue the development of the related biomarkers program;
initiate the pediatric study of Elafibranor in NASH;
commence clinical development of Elafibranor in PBC;
progress its other proprietary research programs and in particular, programs targeting fibrosis ; and
prepare market access for Elafibranor in NASH by reinforcing different teams within the Company.
The Company targets raising c. EUR 30m through the Private Placement.
The second step of this global fundraising would be implemented, depending on the proceeds of the Private Placement, through a rights issue (the « Rights Issue »). It would be launched, depending on market conditions, shortly after the Private Placement. Investors in the Private Placement would be allowed to participate to the Rights Issue.
If all of the Company's programs are implemented at the pace currently expected by the Company, the proceeds of the global fundraising, together with its cash on hand, should allow the Company to finance its development until late 2018-early 2019, when the first results of the RESOLVE-IT trial should be available. The Company has the flexibility, depending on the proceeds raised in the global fundraising, to slow down the development of certain of its programs to meet this timeframe, while keeping the development of Elafibranor in NASH and of the associated biomarkers as a priority.
Jean-François Mouney, Chairman & CEO of GENFIT, commented:
"With this global fundraising we would like to give ourselves the means both to continue our Elafibranor and biomarker programs, which are our priority programs, as well as to launch, in particular, the clinical development of our drug candidates in Primary Biliary Cholangitis and Fibrosis.
We also wish to include, through the Rights Issue, our shareholders in the next stage of the Company's growth, on preferential terms, but also in the value creation that this would generate in the context of licensing agreements to be negotiated. "
The Private Placement will be carried out without shareholders' preferential subscription rights. As per Article L. 225-138 of the French Commercial Code and the nineteenth resolution of the Shareholders General Meeting of the Company dated June 21, 2016 it will be reserved to the categories defined in the above-mentioned resolution, i.e. : (i) to industrial or commercial companies in the pharmaceutical / biotechnology sector, and (ii) to French or foreign investment funds investing in the pharmaceutical / biotechnology sector.
In connection with the Private Placement, the Company will enter into a lock-up agreement (subject to certain customary exemptions, including the potential Rights Issue) for a period ending the later of 90 days following the settlement and delivery of the Private Placement or, as the case may be, of the Rights Issue.
Application will be made to list the new ordinary shares issued pursuant to the Private Placement on the regulated market of Euronext in Paris pursuant to a listing prospectus comprising the 2015 Reference Document ( Document de Référence ) of the Company registered with the French Autorité des Marchés Financiers (" AMF ") on June 29, 2016 under number R.16-062, the Update to 2015 Reference Document filed with the AMF on October 5, 2016, and a Securities Note ( Note d'opération ), including a summary of the prospectus. This listing prospectus will be submitted to the visa application with the AMF. The attention of the public is drawn to the risk factors presented in the listing prospectus. The final terms of the Private Placement will be announced as soon as practicable.
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.
"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.
"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.
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, is currently in a Phase 3 study. With facilities in Lille and Paris, France, and Cambridge, MA (USA), the Company has approximately 110 employees. GENFIT is a public company listed in compartment B of Euronext's regulated market in Paris (Euronext: GNFT – ISIN: FR0004163111). www.genfit.com
The portfolio of the Company is composed of the following proprietary compounds and programs:
the Elafibranor/GFT505 program, Elafibranor being the generic named approved by the World Health Organization to designate the most advanced proprietary drug candidate of the Company and known until then under the name GFT505. This drug candidate has started a Phase III development program for the treatment of NASH, including a pivotal clinical trial under the name RESOLVE-IT, which is ongoing at the date of this press release. The first results should be available by late 2018-early 2019. Subject to satisfactory clinical results obtained during the first stage of this study, and meeting the timelines estimated by the Company for its completion and the authorization of the regulatory agencies, a conditional market authorization could be obtained for Elafibranor in NASH during the course of the second half of 2019 or first half of 2020. The Company also announced that it is filing an IND submission for a Phase 2 trial in Primary Biliary Cholangitis (PBC), aimed at evaluating decrease in alkaline phosphatase (ALP) with elafibranor vs placebo, which could be launched before the end of 2016, subject to applicable regulatory authorizations. The Company is also considering the development of Elafibranor in NASH in pediatric and cirrhosis subpopulations;
two programs of research and validation of novel diagnostic biomarkers in NASH (BMGFT03) on the one hand, and in pre-diabetes (BMGFT02) on the other hand. In the case of BMGFT03 in particular, in 2015, the Company reached a key milestone with the development of a proprietary algorithm enabling the identification, as an alternative to invasive liver biopsy, of NASH patients to be treated with Elafibranor or any other appropriate therapeutic solution. The Company plans to use the Phase III RESOLVE-IT trial to confirm this algorithm all the while increasing its predictive power between now and the end of 2017;
the TGFTX4 program, that aims to develop new anti-fibrotic drug candidates. Within this program, the Company has identified several potential drug candidates that have demonstrated anti-fibrotic activity in cell-based assays and in vivo. Certain of these compounds have come from the pharmacopeia, and the Company contemplates that a drug candidate could be ready for Phase II clinical studies in the first half of 2017. Other compounds are ready to begin pre-clinical development;
the TGFTX1 program, to discover innovative drug candidates targeting RORgt, a nuclear receptor involved in certain inflammatory and autoimmune diseases. With this program, the Company has developed proprietary molecules that effectively inhibit RORgt activity and that have demonstrated beneficial effects in functional in vitro and in vivo assays relevant to the targeted diseases, in particular for their potential benefit in the treatment of several diseases of the liver (such as auto-immune hepatitis) and intestine. Since September 2016, the Company has some of the elements which would allow it to begin pre-clinical development of these compounds in the first half 2017 (see the press release of September 23, 2016);
the TGFTX3 program, targeting Rev-Erba, a nuclear receptor involved in the disruption of circadian rhythms (daily rhythm allowing the body to adapt to environmental changes and regulating various physiological mechanisms, including metabolism), and in the framework of which the Company has developed a series of proprietary agonists modulating this nuclear receptor in vitro and in vitro, and has notably demonstrated their pharmacological activity on the regulation of glucose and lipid metabolism, and hepatic protection;
the TGFTX5 program, that aims to identify and develop drug candidates for chronic inflammatory bowel diseases. Within this program, the Company has in particular demonstrated the preclinical efficacy of Elafibranor in a model of colitis and evaluated in parallel other products derived from Elafibranor.
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, progression of, and results of clinical data from, the RESOLVE-IT trial, review and approvals by regulatory authorities, such as the FDA or the EMA, regarding in particular, Elafibranor in NASH and PBC, as well as other indications, 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 7 "Main Risks and Uncertainties"of the Company's Half Year 2016 Business and Financial Report, 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 has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.
This announcement does not, and shall not, in any circumstances constitute a public offering nor an invitation to the public in connection with any offer.
The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.
The offer and sale of the GENFIT shares were carried out through a private placement to qualified investors, in accordance with Article L. 411-2 of the French Financial and Monetary Code (Code monétaire et financier) and other foreign applicable laws and regulations. There was, and there will be, no public offering in France.
This announcement is an advertisement and not a prospectus within the meaning of Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003, as amended (the " Prospectus Directive ").
With respect to the member States of the European Economic Area which have implemented the Prospectus Directive, no action has been undertaken or will be undertaken to make an offer to the public of the securities referred to herein requiring a publication of a prospectus in any relevant member State. As a result, the securities may not and will not be offered in any relevant member State except in accordance with the exemptions set forth in Article 3(2) of the Prospectus Directive, if they have been implemented in that relevant member State, or under any other circumstances which do not require the publication by GENFIT of a prospectus pursuant to Article 3 of the Prospectus Directive and/or to applicable regulations of that relevant member State.
This document is not an offer of securities for sale nor the solicitation of an offer to purchase securities in the United States of America or any other jurisdiction where such offer may be restricted. Securities may not be offered or sold in the United States of America absent registration under the U.S. Securities Act of 1933, as amended (the " Securities Act "), or an exemption from registration. The shares of GENFIT have not been and will not be registered under the Securities Act, and GENFIT does not intend to make a public offer of its securities in the United States of America.
This document is only being distributed to, and is only directed at, persons in the United Kingdom that (i) are "investment professionals" falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended, the " Order "), (ii) are persons falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations, etc.") of the Order, or (iii) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of Article 21 of the Financial Services and Markets Act 2000) in connection with the issue or sale of any securities may otherwise lawfully be communicated or caused to be communicated (all such persons together being referred to as "Relevant Persons"). This document is directed only at Relevant Persons and must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this document relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. Any person other than a relevant person should not act or rely on this document or any of its contents.
Any investment decision to buy shares in GENFIT must be made solely on the basis of publicly available information regarding GENFIT.
This document may not be distributed, directly or indirectly, in or into the United States of America, Australia, Canada or Japan.
GENFIT | Jean-François Mouney – Chairman & CEO | Ph. +333 2016 4000
MILESTONES – Press Relations | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 – email@example.com
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