Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

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be amended from time to time, and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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

 

Exhibit		Description
99.1		Press Release dated November 09, 2023.

 

 

 

 

 

 

 

 

 

 

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.

 

	GENFIT S.A.
Date: November 09, 2023	By:		/s/ Pascal PRIGENT
			Name: Pascal PRIGENT
			Title: Chief Executive Officer

 

Exhibit 99.1

 

 

 

GENFIT Reports Third Quarter 2023 Financial Information

 

·	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

 

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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

 

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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.

 

 

 

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CONTACT

 

GENFIT | Investors

 

Tel: [phone] | [e-mail]

 

PRESS RELATIONS | Media

 

Stephanie Boyer – Press relations | Tel: [phone] | [e-mail]

 

 

 

 

 

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