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: November 09, 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
INCORPORATION BY REFERENCE
The contents of this report on Form 6-K (including Exhibit 99.1) are hereby incorporated by
reference into the registrant’s registration statement on Form F-3 (File No. 333-271312) and registration statement on Form S-8
(File No. 333-271311) and related prospectuses, as such registration statements and prospectuses may be amended from time to time, and
to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed
or furnished. Information contained on, or that can be accessed through, any website included in Exhibit 99.1 is expressly not incorporated
by reference.
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: November 09, 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
Reports Third Quarter 2023 Financial Information
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Cash and cash equivalents totaled €93.9 million as of September 30, 2023 |
Lille (France); Cambridge
(Massachusetts, United States); Zurich (Switzerland); November 9, 2023 - GENFIT (Nasdaq and Euronext: GNFT),
a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today
announced its cash position as of September 30, 2023 and revenue for the first nine months of 20231.
Cash Position
As of September 30,
2023, the Company’s cash and cash equivalents amounted to €93.9 million compared with €163.6 million a year earlier.
As of June 30, 2023,
cash and cash equivalents totaled €111.8 million.
The decrease in
cash and cash equivalents between June 30, 2023, and September 30, 2023, takes into account our continued research and development efforts,
notably for ELATIVE®, our Phase 3 clinical trial evaluating elafibranor in Primary Biliary Cholangitis
(PBC); UNVEIL-IT™, our Phase 2 clinical trial of VS-01 in Acute-on-Chronic Liver Failure (ACLF); GNS561, as part of our cholangiocarcinoma
program; and NTZ, as part of our ACLF program.
We expect that
our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements until approximately
the fourth quarter of 2024. This is based on current assumptions and does not take into account milestones and royalties that the Company
may receive pursuant to the Collaboration and Licensing agreement with Ipsen dated December 16, 2021, nor does it include exceptional
events. This agreement applies to elafibranor, which is being evaluated in patients with Primary Biliary Cholangitis as part of the Phase
3 ELATIVE® trial, for which positive results were announced on June 30, 2023.
1 Unaudited financial information
under IFRS
Revenue
Revenue2
for the first nine months of 2023 amounted to €14.3 million compared to €14.1 million for the same period in 2022.
Of the €14.3 million in revenues for the first
nine months of 2023, €9.1 million are attributable to the partial recognition of deferred income of €40 million accounted for
in accordance with IFRS 15, in application of the licensing agreement signed with Ipsen in December 2021; and €5.2 million was generated
from the services rendered under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and
September 2023 respectively by GENFIT and Ipsen, in order to facilitate the transition of certain services related to the Phase 3 ELATIVE®
clinical trial until the complete transfer of the responsibility of the trial to Ipsen.
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 Metabolic dysfunction-associated steatohepatitis (MASH) (previously known as nonalcoholic
steatohepatitis – 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
2 Revenue recognized under IFRS
15
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
Company’s potential future revenues and cash runway. 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
PRESS RELATIONS | Media
Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com
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