UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of report: September 26, 2023
Commission File Number: 001-38844
GENFIT S.A.
(Translation of registrant’s name into English)
Parc Eurasanté
885, avenue Eugène Avinée
59120 Loos, France
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover
of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
EXHIBIT LIST
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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GENFIT S.A. |
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| Date: September 26, 2023 |
By: |
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/s/ Pascal PRIGENT |
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Name: Pascal PRIGENT |
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Title: Chief Executive Officer |
Exhibit 99.1
GENFIT
Announces Publication in Nature Medicine Confirming the Performance of its NASH Diagnostic Technology
Lille (France); Cambridge
(Massachusetts, United States); Zurich (Switzerland); September 26, 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 the publication
of data demonstrating the effectiveness of its non-alcoholic steatohepatitis (NASH)1 diagnostic
technology NIS4® by the FNIH’s2 NIMBLE3 project in the scientific journal, Nature Medicine4.
NIMBLE, part of the FNIH Biomarkers Consortium, is a public-private partnership
that brings together U.S. government agencies, academic researchers and industry partners to study the diagnostic performance of non-invasive
biomarkers to assess liver disease. The recent study evaluated five blood-based panels5,
which included NIS4®, NIS2+™’s predecessor.
The study aims to confirm the diagnostic performances of
existing biomarker panels and determine their advantage over commonly used laboratory tests (ALT and FIB-4). Such studies conducted provide
necessary data for the regulatory approval of biomarkers for the diagnosis of at-risk NASH and is a crucial step in moving the field
closer to having qualified Non-Invasive Tests, such as NIS4® or now NIS2+™,
that can be used for widespread clinical use.
The findings, published in the scientific journal Nature
Medicine, concluded that NIS4® achieved an AUROC6
of 0.815 for its intended use of diagnosing at-risk NASH, demonstrating significant superiority over common clinical-laboratory
tools. It also confirmed that NIS4® was the only panel efficient for the diagnosis
of the composite phenotype of at-risk NASH. Regarding the detection of NASH and significant fibrosis (F≥2) independently, NIS4®’s
performance was superior to the other biomarker panels tested, achieving AUROC values of 0.832 and 0.874, respectively.
These findings represent an important
milestone in NIS4® technology’s path to regulatory approval by the U.S Food
and Drug Administration. NIS2+™, the newly published and optimized version of
1
At the EASL Congress in June 2023, it was announced that NASH would now be referred to as Metabolic dysfunction-associated steatohepatitis
(MASH).
2 Foundation for the National
Institutes of Health
3 Non-invasive Biomarkers of
Metabolic Liver Disease
4 https://doi.org/10.1038/s41591-023-02527-w
5 NIS4®, OWLiver,
PROC3, ELF™ and FibroMeter VCTE
6 Area under the receiver operating
characteristic curve
NIS4®,
is currently in the process of being independently evaluated through the NIMBLE consortium.
Arun J Sanyal, M.D., Director of the Stravitz-Sanyal
Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University and Chair of the NIMBLE Consortium, commented:
“Such findings will bring us a step closer towards a fully approved biomarker panel which can be made available for widespread
clinical use and potentially alleviate the major barrier to care and drug development access. NIS4®’s utility as
an effective technology to diagnose at-risk NASH is clearly demonstrated in these findings and we look forward to evaluating NIS4®’s
more advanced version, NIS2+™, in the near future.”
ABOUT GENFIT’S NASH DIAGNOSTIC TECHNOLOGY
NIS2+™ is a blood-based diagnostic technology specifically
designed to detect at-risk NASH among patients with metabolic risk factors based on an independent 2-biomarker panel. It is an optimization
of the NIS4® technology and was developed and validated by GENFIT as a robust technology
across characteristics of interest such as type-2 diabetes, age and sex, allowing large- scale implementation in clinical practice. GENFIT
continues to explore the possibility of obtaining regulatory approval and CE Certificates of Conformity, with a development and commercial
partner, to release an IVD test powered by NIS2+™ technology on the US and European markets.
NIS4®
technology, NIS2+™’s predecessor, is being commercialized by Labcorp in the US and Canada as a Laboratory Developed Test.
Since May 2021, Labcorp has been commercializing NASHnext®, powered by NIS4®
technology, for use in the clinic. For more information, visit: https://nis4.com
ABOUT THE FNIH BIOMARKERS CONSORTIUM
The Foundation for the National Institutes
of Health’s Biomarkers Consortium (BC) leads cross- sector efforts to validate and qualify biomarkers that accelerate the development
of new therapeutics and health technologies. The core operations of the BC are supported through its contributing membership program,
which includes organizations representing private industry and not-for-profit organizations.
ABOUT THE FNIH
The Foundation for the National Institutes of Health (FNIH)
builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH), life sciences
companies, foundations, academia, and regulatory agencies, including the Food and Drug Administration and European Medicines Agency. Through
team science, the FNIH solves complex
health challenges and accelerate breakthroughs for patients,
regardless of who they are or what health challenges they face. The FNIH accelerates new therapies, diagnostics, and potential cures;
advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress
in 1990 to support the mission of the NIH, the FNIH is a not-for- profit 501(c)(3) charitable organization. For more information about
the FNIH, please visit fnih.org
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company dedicated
to improving the lives of patients with rare and severe 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. Its capacity
to develop high potential assets, from early-stages to late development and pre-commercialization stages, is illustrated through the
successful 52-week readout of its Phase 3 trial (ELATIVE®) evaluating elafibranor in Primary Biliary Cholangitis (PBC). Today, GENFIT
has a diversified R&D pipeline covering several therapeutic areas: five programs in acute on chronic liver failure (ACLF) are in
clinical stages (Phase 2) and pre-clinical stages, including hepatic encephalopathy (HE), one of the main complications of ACLF; a Phase
2 clinical program targeting cholangiocarcinoma; and a preclinical program targeting urea cycle disorders (UCD) and organic acidemias
(OA). GENFIT’s pipeline also includes a diagnostic franchise focused on Metabolic dysfunction-associated steatohepatitis (MASH,
formerly known as nonalcoholic steatohepatitis or 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
with respect to GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995 in relation to the
clinical performance of NIS4® and NIS2+™ in NASH and its potential for regulatory
approval and utility in the clinical setting. 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.
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
Tel: +33 3 2016 4000 | investors@genfit.com
GENFIT | Press relations
Stephanie Boyer | Tel: +333 2016 4000 | stephanie.boyer@genfit.com
4
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