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: May 14, 2024
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to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed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: May 14, 2024 |
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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 First Quarter 2024 Financial Information
Lille (France), Cambridge (Massachusetts, United States), Zurich
(Switzerland), May 14, 2024 - 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 March 31, 2024 and revenues for the first three months of 2024.1
Cash position
As of March 31, 2024, the Company’s cash and cash equivalents
amounted to €74.0 million compared with €128.6 million as of March 31, 2023, and €77.8
million as of December 31, 2023.
The stability in cash and cash equivalents between December 31, 2023,
and March 31, 2024 takes into account changes in accounts receivables (notably the receipt of the €13.3 million milestone invoiced
to Ipsen in December 2023) offset by our continued research and development efforts, notably for:
| · | UNVEIL-IT®, our Phase 2 clinical trial evaluating VS-01 in Acute-on-Chronic Liver Failure
(ACLF); |
| · | our cholangiocarcinoma program evaluating GNS561; |
| · | our ACLF program evaluating NTZ; and |
| · | our non-clinical trial of SRT-015 in ACLF. |
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 2025. This
is based on current assumptions and programs and does not include exceptional events. This estimation includes our expectations to receive
future milestone revenue in 2024, subject to approval by applicable regulatory authorities and US and European commercial launches of
elafibranor in Primary Biliary Cholangitis (PBC) by Ipsen, representing a total of approximately
€75.2 million.
Revenues
Revenues for the first three months of 2024 amounted to €1.1
million compared to €5.0 million for the same period in 2023.
This revenue for the first three months of 2024 was generated
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.
___________________________
1 Unaudited
financial information under IFRS
Of the €5.0 million in revenues for the first three
months of 2023, €4.1 million in revenue was attributable to the partial recognition of the €40.0 million deferred income per
IFRS 15 in accordance with the Collaboration and Licensing Agreement signed with Ipsen in 2021. €0.8 million was attributable to
re-billings made in accordance with this agreement. €0.1 million in revenue was generated from the services rendered by GENFIT to
Ipsen in accordance with the Transition Services Agreement signed in 2022.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical
company committed to improving the lives of patients with rare, life-threatening liver diseases whose
medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific
heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs
at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five
assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of
action using different routes of administration. Other active ingredients target other serious diseases, such as cholangiocarcinoma (CCA),
urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to
advanced stages, and in pre-commercialization, was demonstrated with the success of the 52-week Phase 3 ELATIVE® study evaluating
elafibranor in Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+®
in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing
on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich
(Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market
in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake
in the Company's capital. 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 Company’s eligibility to receive future milestone payments from
Ipsen relating to the development and commercial launch of elafibranor in PBC, approval of elafibranor in PBC and potential commercialization
in the United States and Europe as early as 2024, and expected cash runway. The use of certain words, such as "believe", "potential",
"expect", “target”, “may”, “will”, "should", "could", "if"
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 others, 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, and 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 "Risk Factors and Internal Control" of the Company's 2023 Universal
Registration Document filed on April 5, 2024 (no. D.24-0246) with the Autorité des marchés financiers ("AMF"),
which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in the public documents
and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2023 Annual Report
on Form 20-F filed with the SEC on April 5, 2024 and subsequent filings and reports filed with the AMF or SEC or otherwise made public,
by the Company. In addition, even if the results, performance, financial position and liquidity of the Company 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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