In the wake of the global strategic partnership announced today, GENFIT acquires the rights to a new asset

• Exclusive rights for an early novel–stage asset acquired from Genoscience Pharma in cholangiocarcinoma in the United States, Canada and Europeans

• Phase 2 clinical program expected start in 1 hour 2022

• Com agreementes to the heels of the other announcement today oF a long term global strategic partnership with Ipsen including an exclusive license agreement for elafibranor, a Phase 3 active currently evaluated in primary biliary cholangitis

Lille, France; Cambridge, MichiganA; December 1seven, 2021 – GENFIT (Nasdaq and Euronext: GNFT), an advanced stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver disease, is pleased to announce the strengthening of its cholestatic disease franchise through the acquisition of exclusive rights from Genoscience Pharma to develop and market the investigational GNS561 treatment for cholangiocarcinoma in the United States, Canada and Europe, including the United Kingdom and Switzerland. This announcement follows on from today’s other announcement on our global strategic pharmaceutical partnership.

GNS561 is a novel clinical stage autophagy / PPT1 inhibitor developed by Genoscience Pharma and cholangiocarcinoma is an orphan disease. He has completed preclinical studies and a phase 1b trial confirming the rationale for targeting cholangiocarcinoma, a rare malignant liver tumor with high mortality and with limited treatment options.

Under the agreement, Genoscience Pharma is eligible for clinical and regulatory milestone payments and tiered royalties. The first payable milestone depends on the positive results of the phase 2 clinical trials. GENFIT has also undertaken to acquire a stake of 3 million euros in Genoscience Pharma through the subscription of new ordinary shares.

Pascal Prigent, VSOE by GENFIT, declared: “This license agreement with Genoscience Pharma is an immediate extension of the global strategic partnership announced today. The proceeds of this strategic agreement will strengthen the trajectory of our long-term growth and pipeline expansion, as evidenced by the acquisition of the rights to GNS561 in cholangiocarcinoma. This decision align completelys with our strategic roadmap through to broadening our active wallet within our cholestatic diseases franchise through adding a innovative drug candidate, with the potential to meet significant unmet needss for the sick. the scientific justification, with Pclinical and clinical evidence, support further development of the asset, and our plan is to start a phase 2 program in the first half of 2022. We believe that The mechanism of action of GNS561 is very promising. gdespite the current landscape, standard of care, lack of commercialized options and, on the basis KOL opinions, we will interact with regulators to investigate the acceleration paths upon approval, after phase 2. “

The story continues

Philippe Halfon, CEO of Genoscience Pharmacy, added: “This is an important step in the development of GNS561 as a potential new treatment option in liver cancer, as it offers an innovative mechanism of action for patients with high unmet needs. We believe that GENFIT is a highly qualified partner for the development of GNS561 in cholangiocarcinoma and we will bring our expertise to GENFIT to support their development plan. On our side, we will continue, Genoscience Pharma, the development of GNS561 in other indications in oncology as well as research in other therapeutic areas.“

GENFIT to host a conference call on December 17, 2021 at 7.45 a.m.ET / 12.45 p.m. GMT / 1.45 p.m. CET in English and French

The conference calls in English and French will be available on the Investors page of our website, in the events section at https://ir.genfit.com/ or by calling 800-289-0438 (toll-free number). fees in US and Canada), 0800 358 6377 (UK toll free number) or 0805 101 219 (France) five minutes before departure time (confirmation code: 9932717). A replay will be available shortly after the call.

ON CHOLANGIOCARCINOMA

Cholangiocarcinoma is a type of cancer that forms in the thin tubes (bile ducts) that carry bile from the digestive fluid. Cholangiocarcinoma mainly occurs in people over the age of 50. Cholangiocarcinoma is divided into intrahepatic and extrahepatic types depending on where the disease occurs in the bile ducts. Cholangiocarcinoma is often diagnosed at an advanced stage, which makes it difficult for treatment to be successful. Several risk factors for chronic inflammatory lesions and increased cell turnover have been established, such as primary sclerosing cholangitis (a cholestatic disease of the liver), liver fluke, bile duct cysts, hepatolithiasis and toxins . Treatment options for cholangiocarcinoma are limited and associated with high rates of tumor recurrence and short survival times.

ABOUT GNS561

GNS561 is an inhibitor of PPT-1 (Palmitoyl Protein Thioesterase-1) which blocks autophagy. Autophagy is activated in tumor cells in response to certain conditions, due to growth of tumor cells in advanced cancers. One of the key organs involved in the autophagy process is the lysosome. By entering lysosomes and binding to its target, GNS561 has significant inhibitory activity on late stage autophagy, which leads to tumor cell death. GNS561 is an investigational compound and has not been registered by any regulatory authority.

ABOUT GENOSCIENCE PHARMA

Genoscience Pharma is a French clinical-stage biotechnology company developing new lysosomotropic therapies to set a new standard of care against cancer, autoimmune and infectious diseases. Its lead candidate GNS561 is a first-order, phase 2-ready drug candidate that attacks cancer cells by modulating autophagy. Genoscience Pharma is also entering a Phase 2 hepatocarcinoma trial with GNS561. www.genosciencepharma.com

ABOUT GENFIT

GENFIT is an advanced stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease. GENFIT is a pioneer in the field of nuclear receptor drug discovery, with a rich history and a strong scientific heritage spanning more than two decades.

Today, GENFIT has a robust and diverse pipeline, using different compounds and technologies evaluated at different stages of development and in different liver diseases.

Relying on its internal strengths and internal expertise, GENFIT’s R&D focuses on cholestatic diseases and chronic acute liver failure (ACLF): two therapeutic areas with significant unmet medical needs. Currently, the ELATIVE â„¢ Phase 3 clinical trial is evaluating elafibranor (elafibranor is an investigational compound that has not been reviewed or approved by a regulatory authority) in patients with primary biliary cholangitis (PBC) following a successful phase 2 clinical trial. Patient recruitment is expected to be completed in the first quarter of 2022 and baseline data is expected to be announced between the end of the first quarter and the end of the second quarter 2023. In ACLF, a phase 1 clinical program with nitazoxanide has been launched . .

GENFIT has offices in Lille and Paris, France, and Cambridge, MA, USA. GENFIT is a company listed on the Nasdaq Global Select Market and on compartment B of the regulated market of Euronext in Paris (Nasdaq and Euronext: GNFT). www.genfit.com

GENFIT FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements regarding GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the timelines to begin a Phase 2 study of GNS561 in cholangiocarcinoma, the likelihood of success of GNS561 mechanism of action to address the unmet medical need for cholangiocarcinoma and the potential for shortening the path to regulatory approval. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe” “,” Wish “,” may “,” could “,” allow “,” seek “,” encourage “or” have confidence “or (as the case may be) the negative forms of these terms or any other variation of these terms or other similar terms their meaning is intended to identify forward-looking statements. Although the Company believes that its projections are based on reasonable expectations and assumptions of the management of the Company, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially. of those expressed, implied or proposed by forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, particularly with respect to the safety, biomarkers, progress and results of its ongoing and planned clinical trials, review and approvals. by the regulatory authorities of its drug and diagnostic candidates, the impact of the ongoing COVID-19 pandemic, fluctuations in exchange rates and the Company’s continued ability to raise capital to finance its development, as well as the risks and uncertainties discussed or identified in the Company’s public documents with the French authorities. Authority from Markets Financial (“AMF”), including those listed in chapter 2 “Main risks and uncertainties” of the Company’s 2020 Universal Registration Document filed with the AMF on April 23, 2021 under number D.21-0350, available on the Company’s website (www.genfit.com) and on the AMF’s website (www.amf-france.org), and public documents and reports filed with the Securities and Exchange Commission (“SEC ) Of the United States, including the Company’s 2020 Annual Report on Form 20 -F filed with the SEC on April 23, 2021 and subsequent filings and reports filed with the AMF or the SEC, or otherwise rendered public by the Company. In addition, even if the results, performance, financial position and liquidity of the Company, as well as the development of the sector in which it operates are in accordance with these forward-looking statements, they may not be predictive of the results or developments of future periods. These forward-looking statements speak only as of the date of publication of this document. Except as required by applicable law, the Company does not undertake any obligation to update or revise any information or forward-looking statement, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors

Phone: +33 3 2016 4000 | [email protected]

PRESS RELATIONS | Media

Stéphanie Boyer – Press relations | Phone: +333 2016 4000 | [email protected]

Attachment