GENFIT

Update on Regulatory and Clinical Activities Amid the COVID-19 Pandemic

GENFIT: Update on Regulatory and Clinical Activities Amid the COVID-19 Pandemic

Lille (France), Cambridge (Massachusetts, United States), March 31, 2020 – GENFIT (Nasdaq and Euronext: 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 reported an update on its regulatory and clinical activities in the context of the COVID-19 pandemic.

The unprecedented spread of COVID-19 is impacting the global health and business ecosystem, GENFIT included. During this crisis, our priorities are to ensure the safety and well-being of our employees, of the patients and healthcare professionals involved in our clinical trials, as well as the integrity of our ongoing clinical trials.

GENFIT is therefore monitoring the situation closely and, in light of our priorities and in accordance with the recently issued guidance documents of the U.S. Food and Drug Administration (FDA) and European Medicines Agency, we have worked with our contract research organizations, trial sites and investigators to critically reassess all our existing programs.

RESOLVE-IT Phase 3 trial in NASH with fibrosis continues

As announced previously, the first ~1000 patients required to support regulatory approval have completed their final visits and the database related to that cohort was locked at the end of February, as planned. The un-blinding of the study and subsequent announcement of interim results will take place after receipt and incorporation of insight from the FDA. We do not currently anticipate that the COVID-19 situation will significantly delay receipt of this feedback.

After careful consideration of the potential benefits to NASH patients in continuing treatment, we have also decided to continue the extension phase of RESOLVE-IT. Working with our contract research organization, we have implemented appropriate measures to ensure the safety of patients who are already participating in the study: virtual clinic visits, local laboratory assessment, home delivery of study drug, and halting the screening of new patients. Additional measures may be implemented, as required by the evolving COVID-19 situation.