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: December 7, 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to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed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: December 7, 2023 |
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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
Ipsen confirms U.S. FDA grants priority review for New
Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC
| · | New
Drug Application granted priority review with PDUFA date set for June 10, 2024 |
| · | European
Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for
elafibranor |
| · | Investigational
elafibranor is the first novel second-line treatment for primary biliary cholangitis (PBC)
to be filed in E.U. and U.S. in nearly a decade |
Paris (France), December 07,
2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S.
Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. An oral, once-daily dual
peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first
novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade. The target FDA PDUFA date under priority
review is June 10, 2024.
The European Medicines Agency (EMA) has also validated Ipsen’s Marketing
Authorization Application (MAA) for elafibranor and the review of the submission to the EMA’s Committee for Medicinal Products for
Human Use (CHMP) began on 26 October 2023. Furthermore, a third simultaneous regulatory filing of elafibranor has been validated for review
by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
“We are delighted to have achieved simultaneous filings for elafibranor,
which is in line with our ambition to be able to bring a new and much needed medicine to as many people living with PBC as rapidly as
possible,” said Christelle Huguet, EVP and Head of Research & Development, Ipsen.
“This is a condition where many patients are living with worsening disease and debilitating symptoms despite being on treatment.
Elafibranor, if approved, has the potential to change the management of this challenging condition for people living with PBC, offering
a new second line treatment choice, where the number of effective options are currently limited.”
![](https://www.sec.gov/Archives/edgar/data/1757064/000117184323007481/footer.jpg)
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PBC is a rare, progressive, autoimmune cholestatic liver
disease1 in which bile ducts in the liver are gradually destroyed.2
The damage to bile ducts can inhibit the liver’s ability to rid the body of toxins, and can lead to scarring of liver
tissue, known as cirrhosis.1,2,3 Common symptoms of PBC include fatigue and pruritus
(itch), which can be severely debilitating.4 Untreated, PBC can lead to liver failure,
or in some cases death.1 It primarily affects women, with nine women diagnosed for every man.3
A significant proportion of people living with PBC do not benefit from existing therapies.5, 6 7
“These simultaneous regulatory submission acceptances are another important
step in the elafibranor journey. We are pleased to be partnering with Ipsen, who we know has a good understanding of the rare-disease
regulatory process,” said Pascal Prigent, Chief Executive Officer of GENFIT. “We
know they share the same goal as GENFIT, to bring a new, much needed treatment option to people living with PBC as fast as possible;
we look forward to elafibranor’s progress through the regulatory review processes.”
ABOUT ELAFIBRANOR
Elafibranor is an oral, once-daily, dual peroxisome activated
receptor (PPAR) alpha/delta (α,δ) agonist, currently under investigation as a treatment for patients with PBC, a rare cholestatic
liver disease. Elafibranor, through activation of PPAR α,δ targets multiple cell types and biological processes involved in
the pathophysiology of PBC, including cholestasis (impairment of bile flow in the liver), bile toxicity, inflammation and fibrosis and
bile acid output. In 2019, elafibranor was granted a Breakthrough Therapy Designation by the U.S Food and Drug Administration in adults
with PBC who have an inadequate response to ursodeoxycholic acid (UDCA) the existing first-line therapy for PBC. Elafibranor has not received
approval by regulatory authorities anywhere in the world.
______________________________
1 Younossi ZM, et al. 2019. Diagnosis and Management of Primary Biliary
Cholangitis. Am J Gastroenterol. 114(1):48–63.
2 European Association for the Study of the Liver. 2017. EASL Clinical
Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 67(1):145-172.
3 Galoosian A, et al. 2020. Clinical updates in primary biliary cholangitis:
trends, epidemiology, diagnostics, and new therapeutic approaches. J Clin Transl Hepatol. 8(1), pp. 49-60.
4 Kumagi T & Heathcote EJ. 2008. Primary biliary cirrhosis. Orphanet
J Rare Di. 3:1.
5 Ali AH, Byrne TJ, Lindor KD. 2015. Orphan drugs in development
for primary biliary cirrhosis: challenges and progress. Orphan Drugs: Research and Reviews. 5(1), pp..83-97 numbers.
6 Corpechot C, et al. 2011. Early primary biliary cirrhosis: biochemical
response to treatment and prediction of long-term outcome. J Hepatol. 55:1361-7.
7 Aguilar MT and Chascsa DM. 2020. Update on emerging treatment options
for primary biliary cholangitis. Hepat Med. Pp.69-77.
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![](https://www.sec.gov/Archives/edgar/data/1757064/000117184323007481/hdr.jpg)
ABOUT ELATIVE®
ELATIVE is a multi-center, randomized, double-blind, placebo-controlled
Phase III clinical trial, with an open-label long-term extension (NCT04526665). ELATIVE evaluated the efficacy and safety of elafibranor
80mg once daily versus placebo for the treatment of patients with PBC with an inadequate response or intolerance to UDCA. The trial enrolled
161 patients who were randomized 2:1 to receive either elafibranor 80mg once daily or placebo. Patients with an inadequate response to
UDCA would continue to receive UDCA in combination with elafibranor or placebo, while patients unable to tolerate UDCA would receive
only elafibranor or placebo. Data confirmed the potential for elafibranor to be an effective new treatment option for PBC, with 13 times
more patients achieving a biochemical response, suggesting an improvement in disease progression, when treated with elafibranor compared
with patients on placebo: 47% placebo-adjusted difference, elafibranor 80mg (51%) compared with placebo (4%) (P<0.001).8
Reductions in levels of alkaline phosphatase (ALP) were rapid,
seen as early as Week 4 in the elafibranor group, and were sustained through Week 52, with a decrease in ALP of 41% on elafibranor compared
with placebo.8 ALP and bilirubin are important predictors of PBC disease progression. ELATIVE also investigated the effect of treatment
with elafibranor on pruritus (severe itch), a significant symptom burden amongst people living with PBC. Findings from the secondary
endpoint using the PBC Worst Itch NRS score, showed a reduction in pruritis for elafibranor, which was not statistically significant.
Data reported from two separate patient-reported outcome measures demonstrated reductions in moderate to severe pruritus, which favored
elafibranor versus placebo.8 Elafibranor was well-tolerated in the trial and has a well-documented safety profile. Adverse events occurring
in >10% of patients and more frequently on elafibranor versus placebo included abdominal pain, diarrhea, nausea, and vomiting.8
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
___________________________
8 Kowdley. K.V, et al. NEJM. 2023. DOI: 10.1056/NEJMoa2306185
![](https://www.sec.gov/Archives/edgar/data/1757064/000117184323007481/hdr.jpg)
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
ABOUT IPSEN
Ipsen is a global biopharmaceutical company with a focus on
bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Its pipeline is fueled
by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Its
teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.
Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY).
For more information, visit https://www.ipsen.com/.
GENFIT - 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 potential of elafibranor as a safe and effective second-line treatment for PBC, the opportunity to manage
the disease progression and the potential of elafibranor to improve pruritus, reduce cholestatic injury and improve liver function. 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
![](https://www.sec.gov/Archives/edgar/data/1757064/000117184323007481/hdr.jpg)
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.
IPSEN – FORWARD LOOKING STATEMENTS
The forward-looking statements, objectives and targets contained
herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks
and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the
above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic
conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’
and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events,
including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account
external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and
assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively
on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties,
notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market
or reaching its commercial targets, notably
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for regulatory or competition reasons. Ipsen must face
or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development
process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced
to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that
favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical
trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine
will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking
statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic
factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare
legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors;
challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict
future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk;
dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation,
including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines
which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s
activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain
any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations
could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or
undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change
in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s
business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés
Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal
Registration Document, available on ipsen.com.
GENFIT CONTACTS
INVESTORS
Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33
3 2016 4000 | jean-christophe.marcoux@genfit.com
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MEDIA
Stephanie Boyer – Press relations | Tel: +333 2016 4000
| stephanie.boyer@genfit.com
IPSEN CONTACTS
INVESTORS
Craig Marks | Tel: +44 (0)7584 349 193 | craig.marks@ipsen.com
Nicolas Bogler | Tel: +33 6 52 19 98 92 | nicolas.bogler@ipsen.com
MEDIA
Amy Wolf | Tel: +41 79 576 07 23 | amy.wolf@ipsen.com
Ioana Piscociu | Tel: +33 6 69 09 12 96 | Ioana.piscociu@ipsen.com
Anna Gibbins | Tel: +44 (0)7717 801 900 | anna.gibbins@ipsen.com
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