GENFIT: Third Quarter 2016 Financial Information
(Unaudited financial information in accordance with IFRS)
› Cash and cash equivalents of €84.86 million as at September 30, 2016
› Capital increases of a total gross amount of €78.5 million carried out successfully in October and November 2016
› Revenues for first nine months of 2016 of €0.22 million
Lille (France), Cambridge (Massachusetts, United States), November 8, 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, today announced its cash and cash equivalents as at September 30, 2016 and its revenues for the first nine months of 2016.
• Cash position
As at September 30, 2016, the Company’s cash and cash equivalents (“Cash”) amounted to €84.86 million compared with €64.32 million for the same period in 2015.
Thereafter in early October 2016, GENFIT carried out a capital increase by way of a private placement, followed by, at the beginning of November 2016, a rights issue, which allowed the Company to raised a total gross amount of €78.5 million.
The net proceeds of these two capital increases are thus added to the €84.86 in Cash as at September 30, 2016.
Revenues for the first nine months of 2016 amount to €0.22 million compared to €0.45 million for the same period in 2015.
• Significant events of the third quarter 2016
Regarding elafibranor, the third quarter was marked by the filing of an IND (Investigational New Drug) for a Phase 2 trial in a new indication, Primary Biliary Cholangitis (PBC). The FDA has since approved this IND.
In the framework of its program for the discovery and development of biomarkers in NASH, the Company also announced the launch of a large-scale qualification program of its proprietary non-invasive diagnostic based on miRNAs for the identification of NASH patients to be treated; the validation, with an independent cohort, of miRNAs discovered in the second half 2015; and the discovery of a new set of highly predictive miRNAs. Finally, in relation to the Company’s TGFTX1 program, the Company identified several new RORgt inverse agonists as drug candidates for regulatory pre-IND studies.
• Upcoming event: AASLD Annual Meeting (“The Liver Meeting”, Boston, November 11-15, 2016)
The AASLD selected five GENFIT abstracts that will highlight post-hoc analyses of the GOLDEN-505 Phase 2 trial, the potential of non-invasive biomarkers identified by GENFIT to improve the identification of NASH patients to be treated, novel results of rodent NASH models compared with human NASH, and the importance of treating the histological parameters of NASH, and more precisely necro-inflammation, in the regression of fibrosis.
On this occasion, GENFIT will host three events:
− An analyst and investor event, with the participation of four internationally-renowned experts,
− A scientific advisory board dedicated to biomarkers in NASH, and
− A scientific advisory board on fibrosis.
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, 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
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 4 “Risk Factors” (“Facteurs de Risque”) of the Company’s 2015 Registration Document registered with the French market authority (AMF) on June 29, 2016 under n° R.16-062, 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 press release 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.
GENFIT | Jean-François Mouney – Chairman & CEO | Ph. +333 2016 4000
MILESTONES – Press Relations | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 – firstname.lastname@example.org
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com