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: March 10, 2025
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not superseded by documents or reports subsequently filed or furnished.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: March 10, 2025 |
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
Royalty
Financing with HCRx: GENFIT Announces Approval of the Amendment of the Terms and Conditions of its 2025 OCEANEs
| • | All
resolutions approved by bondholders |
| | • | Closing
of Royalty Financing and receipt of first €130 million instalment expected shortly |
| | • | Upon
closing of the Royalty Financing, GENFIT will implement the Repurchase of the 2025 OCEANEs
and pay the Consent Fee |
Lille
(France), Cambridge (Massachusetts, United States), Zurich (Switzerland), March 10, 2025 -
GENFIT (Nasdaq and Euronext: GNFT), a
biopharmaceutical company dedicated to improving the lives of patients with rare and
life-threatening liver diseases (the “Company”), today announces the results of the bondholders’
vote at the general meeting of the 2025 OCEANEs holders which took place this Monday,
March 10, 2025 at 2:30pm (Paris time): all resolutions proposed by the Company were approved.
General
meeting of the 2025 OCEANEs holders
The
terms and conditions of the 2025 OCEANEs contained a negative pledge clause which limited the
ability of the Company to grant security interests to its creditors upon its present or future assets or revenues. The closing of the
royalty financing with HCRx (the “Royalty Financing”), which was signed and announced by GENFIT on January 30, 2025, was
subject to approval of 2025 OCEANEs bondholders of an amendment to this negative pledge clause,
allowing for the grant of the security interest contemplated in the Royalty Financing documentation, and other customary closing
conditions.
All
resolutions proposed by the Company to the bondholders were approved unanimously, at 100% of the votes cast, with a quorum of 95.79%.
The
Company can therefore move forward with preparation for the closing of the Royalty Financing, which will be announced in a subsequent
press release.
The
result of the vote resolution by resolution is available on the website of the Company (https://ir.genfit.com/financials/General-Meeting).
Implementation
of the Repurchase
As
announced on February 10, 2025 and February 14, 2025, the Company proposed to all of the 2025
OCEANEs holders to enter into a Put Option Agreement, pursuant to which the Company unconditionally
and irrevocably undertook to repurchase the 2025 OCEANEs of such holder at a price of EUR 32.75 per bond, subject to approval
by the general meeting of the 2025 OCEANEs holders of the amendment of the terms and conditions
of the 2025 OCEANEs and the closing of
the
Royalty Financing (the “Repurchase”). Holders have until March 19, 2025 to exercise this
option.
The
settlement of the Repurchase is expected to occur on March 26, 2025. The repurchased 2025 OCEANEs
will be canceled by the Company.
Payment
of the Consent Fee
The
Company also undertook, subject to the approval of the amendment of the terms and conditions of
the 2025 OCEANEs and the closing of the Royalty Financing, to pay a consent fee (the “Consent
Fee”) of EUR 0.90 to the holders of 2025 OCEANEs still outstanding after cancellation of the
repurchased 2025 OCEANEs. The Consent Fee will only be paid after the Repurchase has taken place.
The 2025 OCEANEs that have been bought back by the Company as part of the Repurchase (or
that have been converted prior to 5:00 p.m. (Paris time) on the date falling 2 business days prior to the date of payment of the
Consent Fee) will thus not receive the Consent Fee.
The
payment of the Consent Fee is expected to occur on April 14, 2025.
Anticipated
Calendar of Events
| March
19, 2025 |
Deadline
for relevant 2025 OCEANEs holders to exercise their put option under the Put Option Agreements |
| March
26, 2025 |
Repurchase
settlement date |
| April
14, 2025 |
Payment
of the Consent Fee |
ABOUT
GENFIT
GENFIT
is a 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 assets 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 in the accelerated approval of
Iqirvo® (elafibranor1) by the U.S. Food and Drug Administration, the European Medicines Agency
and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT
also has a
1
Elafibranor is marketed and commercialized in the U.S by Ipsen under the trademark Iqirvo®.
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 closing of the Royalty Financing and its implementation, and the implementation
calendar of the OCEANEs 2025 Repurchase. 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, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, 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, the Half-Year Business and Financial Report dated September 19,
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 press release. 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.
CONTACTS
GENFIT
| Investors
Tel:
+33 3 2016 4000 | investors@genfit.com
GENFIT
| Media
Stephanie
Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com
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