On 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, reported its cash position as of March 31, 2020 and revenues for the first three months of 2020 (Press release, Genfit, MAY 18, 2020, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2020-financial-information-genfit [SID1234561498]).
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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.
GENFIT remains fully committed to developing NIS4, its non-invasive diagnostic technology, to identify at-risk NASH patients.
With regards to PBC (Primary Biliary Cholangitis), given elafibranor’s activity in Phase 2, and its safety profile confirmed by the RESOLVE-IT interim data, and because PBC is an autoimmune disease unrelated to the metabolic origins of NASH, GENFIT is confident in its Phase 3 development program evaluating elafibranor in this indication.
Finally, GENFIT remains open to opportunities that could create value for the Company, whether through forging new strategic partnerships or new scientific collaborations.
GENFIT plans to share its updated corporate strategy in the Fall 2020, once a decision regarding the RESOLVE-IT trial is taken, including potential decisions regarding its product pipeline.
Financial implications
GENFIT is reviewing all non-essential expenses and a first series of measures includes terminating all marketing and commercialization readiness activities for elafibranor in NASH.
However, since no immediate decision can be taken regarding the future of the RESOLVE-IT trial, the trial will continue and its associated costs will continue , including those related to:
Contract Research Organization activities; and
patient monitoring, which cannot be interrupted abruptly due to ethical and regulatory concerns.
In the event a decision is taken to discontinue the RESOLVE-IT trial in the Fall 2020, given the size and complexity of the study, residual costs are to be expected and the full impact of the decision on the Company’s cash burn will not be noticeable until several months following the termination of the trial.