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.
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.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to the discovery and development of innovative
therapeutic and diagnostic solutions in metabolic and liver related
diseases where there are considerable unmet medical needs,
corresponding to a lack of approved treatments. GENFIT is a leader
in the field of nuclear receptor-based drug discovery, with a rich
history and strong scientific heritage spanning more than two
decades. Its most advanced drug candidate, elafibranor, is
currently being evaluated in a pivotal Phase 3 clinical trial
(“RESOLVE-IT”) as a potential treatment for NASH and GENFIT plans
to initiate a Phase 3 clinical trial of elafibranor in patients
with PBC. As part of GENFIT’s comprehensive approach to clinical
management of patients with NASH, the Company is also developing a
new, non-invasive blood-based diagnostic test, NIS4™, which, if
approved, could enable easier identification of patients with NASH.
With facilities in Lille and Paris, France, and Cambridge, MA, USA,
the Company has approximately 200 employees. GENFIT is a publicly
traded company listed on the Nasdaq Global Select Market and on
compartment B of Euronext’s regulated market in Paris (Nasdaq and
Euronext: GNFT). www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements, including those within the meaning of
the Private Securities Litigation Reform Act of 1995, with respect
to GENFIT, including statements regarding our expected future
performance, business prospects, financial perspective, corporate
strategy, events and plans, including timing of further analyses
and the publication of the full data set of the interim results of
our Phase 3 RESOLVE-IT clinical trial, our expected clinical and
regulatory strategy for elafibranor, discussions with regulatory
authorities regarding RESOLVE-IT, the impacts of decisions
surrounding the future of the RESOLVE-IT trial on our cash
position, and the timing of clinical and regulatory milestones in
our PBC and NIS4 programs. The use of certain words,
including “believe,” “potential,” “expect” and “will” and similar
expressions, is intended to identify forward-looking
statements. Although the Company believes its expectations
are based on the current expectations and reasonable assumptions of
the Company’s management, these forward-looking statements are
subject to numerous known and unknown 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 safety, biomarkers, progression of, and
results from, its ongoing and planned clinical trials, review and
approvals by regulatory authorities of its drug and diagnostic
candidates and the Company’s continued ability to raise capital to
fund its development, as well as those risks and uncertainties
discussed or identified in the Company’s public filings with the
French Autorité des marchés financiers (“AMF”), including those
listed in Section 4 “Main Risks and Uncertainties” of the Company’s
2018 Registration Document filed with the AMF on February 27, 2019
under n° D.19-0078, which is available on GENFIT’s website
(www.genfit.com) and on the website of the AMF (www.amf-france.org)
and public filings and reports filed with the U.S. Securities and
Exchange Commission (“SEC”), including the Company’s final
prospectus dated March 26, 2019, and subsequent filings and reports
filed with the AMF or SEC, or otherwise made public, by the
Company. In addition, even if the Company’s results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. These forward-looking
statements speak only as of the date of publication of this
document. Other than as required by applicable law, the Company
does not undertake any obligation to update or revise any
forward-looking information or statements, whether as a result of
new information, future events or otherwise.
CONTACT
GENFIT | Investors
Naomi EICHENBAUM – Investor Relations | Tel: +1
(617) 714 5252 | investors@genfit.com
PRESS RELATIONS | Media
Hélène LAVIN – Press relations | Tel: +333 2016
4000 | helene.lavin@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 |
www.genfit.com
- GENFIT: Reports First Quarter 2020 Financial Information