GENFIT

Reports First Quarter 2020 Financial Information GENFIT: Reports First Quarter 2020 Financial Information

GENFIT: Reports First Quarter 2020 Financial Information
(Unaudited financial information under IFRS)

• Cash and cash equivalents totaled  €252 million as of March 31, 2020
• Additional information regarding implications of interim analysis of top-line RESOLVE-IT data

Lille (France), Cambridge (Massachusetts, United States), May 18, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced its cash position as of March 31, 2020 and revenues for the first three months of 2020.

Cash position

As of March 31, 2020, the Company’s cash and cash equivalents amounted to €252.0 million compared with €314.1 million as of March 31, 2019 and €276.7 million as of December 31, 2019.

Revenues

Revenues for the first three months of 2020 amounted to €102 thousand compared to €1 thousand for the same period in 2019.  Revenues mainly consisted of revenues from services provided to Terns Pharmaceuticals pursuant to the collaboration and license agreement in relation to their clinical trials.

Additional Information

Following the May 11, 2020 announcement of the interim results from the RESOLVE-IT Phase 3 clinical trial evaluating elafibranor in adults with NASH and fibrosis, GENFIT outlines the main operational and financial implications of this announcement:

Operational implications

Elafibranor did not show a statistically significant effect on the primary endpoint of NASH resolution without worsening of fibrosis, and therefore the top-line results do not support an application for accelerated approval by the FDA (U.S. Food and Drug Administration) under Subpart H or conditional approval by the EMA (European Medicines Agency).

However, before taking a final decision regarding the discontinuation, amendment or continuation of the RESOLVE-IT trial, GENFIT will review in detail the full dataset and will conduct additional analyses in order to:

• Understand why the placebo response rate was higher than what was observed in other late stage clinical trials using similar protocols;
• Determine whether there is still a potential for elafibranor in specific subpopulations.

GENFIT will then engage with the FDA and the EMA, and will take a decision regarding the discontinuation, amendment or continuation of the RESOLVE-IT trial following its discussions with regulatory authorities.