- GENFIT to lead 3 key events
on ACLF during AASLD:
- ACLF Day for
Investors/Analysts on November 11, 2023
- Patient Advocacy Council
meeting on November 11, 2023
- ACLF Investigator event on
November 12, 2023
- Detailed interim data from
the ELATIVE® Phase 3 results
evaluating elafibranor in PBC to be presented by GENFIT’s partner
Ipsen, in a late breaking oral session on November 13,
2023
- GENFIT to present new data
on its NASH1 diagnostics
technology
Lille (France), Cambridge
(Massachusetts, United States), Zurich (Switzerland), November 2
2023 - GENFIT (Nasdaq and Euronext:
GNFT), a late-stage biopharmaceutical company dedicated to
improving the lives of patients with rare and severe liver
diseases, today announced that it will present an update on its
scientific and corporate progress at The Liver Meeting® 2023
organized by the American Association for the Study of Liver
Diseases (AASLD), which will take place in Boston, MA (USA) from
November 10-14, 2023.
GENFIT to lead 3 key events on Acute on
Chronic Liver Failure (ACLF) during AASLD
ACLF DayGENFIT will host an
Investor/Analyst event on Saturday, November 11, 2023 at 12.30pm ET
in Boston with the participation of key stakeholders:
- Dr. Jennifer Lai (MD, MBA, FACP,
Transplant hepatologist, University of California, San Francisco
(UCSF), USA) will present the ACLF disease state, patient journey
and unmet medical needs in ACLF
- Robert Stolper, Managing Principal
and Pierre-Antoine Andre, Vice President from IQVIA will present
the ACLF market opportunity
ACLF Investigator EventGENFIT
will host an ACLF Investigator event on Sunday, November 12, 2023
at 6.30pm ET at the Hilton Boston Back Bay, Westminster.
Participants include study investigators, principal investigators
and other healthcare professionals from the US, France, Germany and
the UK.
Patient Advocacy Council
Meeting Two Patient Advocacy Council sessions will be held
on Saturday November 11, 2023. Topics on the agenda include
developing a robust patient engagement plan with a specific focus
on ACLF, and further initiatives to facilitate patient access to
innovative medicine through clinical trials and patient
perspectives and insights. Participants in this event include Dr.
Jennifer Lai (MD, MBA, FACP) and the Global Liver Institute.
Interim data disclosure for the ELATIVE®
Phase 3 trial evaluating elafibranor in PBC
Ipsen will present the full 52-week results from
the ELATIVE® Phase 3 trial evaluating elafibranor in Primary
Biliary Cholangitis (PBC) in a late-breaking oral session (Abstract
#484, Monday, November 13 at 4.45pm ET).
Following the late-breaker presentation of the
ELATIVE® Phase 3 interim results, Ipsen plans to host a conference
call for analysts and investors on Tuesday November 14 at 4.00pm
CET / 10.00am ET. Joining the event will be Dr. Christopher Bowlus,
Lena Valente Professor and Chief of the Division of
Gastroenterology and Hepatology at the University of California
Davis School of Medicine, presenter of the late-breaker
session.
GENFIT’s NASH diagnostics technology
presentations
GENFIT will present new data on its NASH
diagnostics technology, including:
- Performances of NIS2+™ and other
non-invasive tests for the detection of at-risk NASH along the BMI
(Body Mass Index) spectrum (Poster #2089-A)
- The impact of BMI on NIS2+™ and
established non-invasive tests for the evaluation of non-alcoholic
liver disease (15’ Oral Presentation #238, Pr. Sven Francque)
- The sequential use of FIB-4 and
NIS2+™ for an accurate detection of non-cirrhotic at-risk NASH
patients for enrollment in NASH clinical trials (Poster of
Distinction #2100-A)2
- NIS2-mice, an adaptation of the
clinical NIS2+™ diagnostic test for the detection of NAS ≥4 & F
≥2 in GAN diet-induced obese and biopsy confirmed mouse model of
NASH with advanced fibrosis (Poster #2082-A, in collaboration with
Gubra)
LabCorp Product TheaterLabCorp,
GENFIT’s commercial partner for its diagnostics technology, will
also host a Product Theater, highlighting recent data for NIS4® and
NIS2+™ technology and their use in patient management, as well as
in clinical trials. A 30-minute presentation will be held with Dr.
Stephen Harrison speaking on Monday, November 13 from 1:30-2:00 PM
ET at the Plaza Level exhibit hall (Product Theater #2).
END
ABOUT AASLD
AASLD is the leading organization of scientists
and health care professionals committed to preventing and curing
liver disease. AASLD fosters research that leads to improved
treatment options for millions of liver disease patients. They
advance the science and practice of hepatology through educational
conferences, training programs, professional publications, and
partnerships with government agencies and sister societies.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with rare and
life-threatening liver diseases characterized by high unmet medical
needs. GENFIT is a pioneer in liver disease research and
development with a rich history and strong scientific heritage
spanning more than two decades. Today, GENFIT has a growing and
diversified pipeline with programs at various development stages.
The Company's area of focus is Acute on Chronic Liver Failure
(ACLF). Its ACLF franchise consists of five assets in development:
VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE. These are all based on
differentiated mechanisms of action leveraging complementary
pathways. Other assets target other life-threatening disease
indications such as cholangiocarcinoma (CCA) and Urea Cycle
Disorders (UCD)/Organic Acidemias (OA). GENFIT’s track record in
bringing early-stage assets with high potential to late development
and pre-commercialization stages is highlighted in the successful
52-week Phase 3 ELATIVE® trial evaluating elafibranor in PBC.
Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic
franchise focused on MASH (previously known as NASH) and ammonia.
GENFIT has facilities in Lille and Paris (France), Zurich
(Switzerland) and Cambridge, MA (USA). 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). In 2021, IPSEN became one of GENFIT’s largest
shareholders and holds 8% of the company’s share capital. For more
information, visit 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, but not limited to statements about the
clinical performance of GENFIT’s NASH diagnostics technology. The
use of certain words, including “believe”, “potential,” “expect”,
“target”, “may” 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 in relation to
safety of drug candidates, cost of, progression of, and results
from, our ongoing and planned clinical trials, review and approvals
by regulatory authorities in the United States, Europe and
worldwide, of our drug and diagnostic candidates, potential
commercial success of elafibranor if approved, exchange rate
fluctuations, our continued ability to raise capital to fund our
development, as well as those risks and uncertainties discussed or
identified in the Company’s public filings with the AMF, including
those listed in Chapter 2 “Main Risks and Uncertainties” of the
Company’s 2022 Universal Registration Document filed with the AMF
on April 18, 2023, which is available on the Company’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 2022 Annual
Report on Form 20-F filed with the SEC on April 18, 2023 and
subsequent filings and reports filed with the AMF or SEC, including
the Half-Year Business and Financial Report at June 30, 2023 or
otherwise made public, by the Company.
CONTACT
GENFIT | Investors
Tel: +33 3 2016 4000 | investors@genfit.com
GENFIT | Press relations
Stephanie Boyer | Tel: +333 2016 4000 |
stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 | www.genfit.com
1 At EASL Congress in June 2023 it was announced that
nonalcoholic steatohepatitis (NASH) would now be referred to as
Metabolic dysfunction-associated steatohepatitis (MASH).
Nonalcoholic fatty liver disease (NAFLD) will now be referred to as
metabolic dysfunction-associated steatotic liver disease (MASLD).
GENFIT is progressively transitioning its documentation over to
this new nomenclature and both NASH and MASH terms may appear in
our documents during this period.2 Abstract identified as “Poster
of Distinction.” These are classified as being in the top 5% of
scored poster abstracts and will receive special recognition in the
Poster Hall.
- GENFIT to Present Update on Scientific and Corporate Progress
at The Liver Meeting® 2023
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