GENFIT : Shareholders Letter 16 - May 2024

SHAREHOLDERS' LETTER

N° 16 - May 2024

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Dear Shareholders,

GENFIT's Shareholder Meeting will be held on May 22, 2024, at 10 a.m. at the Faculty of Pharmaceutical Sciences in Lille, located at 3 rue du Professeur Laguesse, Lille. This annual meeting is an opportunity for the Company's management team to exchange with our shareholders.

In June of 2023, we celebrated a pivotal moment in our Company's history. Over 15 years of research and development efforts yielded positive interim data in the pivotal Phase 3 ELATIVE® trial evaluating elafibranor in Primary Biliary Cholangitis (PBC). Other milestones were also reached, including: the publication of more detailed clinical trial results in one of the world's leading medical journals, followed by the submission in record time and acceptance of the marketing authorization applications submitted by our partner Ipsen.

If the marketing authorization applications for elafibranor are approved in 2024, these achievements should accelerate our shift towards a "new GENFIT". This evolution could lead to a more stable revenue stream, thanks to PBC and the licensing agreement with our partner Ipsen, helping to finance our strategic pivot towards Acute on-Chronic Liver Failure (ACLF) and other liver diseases.

Pascal Prigent,

CEO of GENFIT

PBC: Success of ELATIVE® and its Implications	2
A long-awaited success for patients and clinicians alike	2
Implications for GENFIT	2
ACLF: a Franchise Enriched by 2 New Assets in 2023	3
An urgent medical need	3
A selective and well-considered choice of therapeutic targets	3
Strengthened leadership	4
Beyond ACLF	4
How to vote	6

1. At 52 weeksc
2. By US, European and UK regulatory authorities

GENFIT - Newsletter n°16 - May 2024

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1.

PBC : Success of ELATIVE® and its implications

A long-awaited success for patients and clinicians alike

The interim data from ELATIVE® is a significant breakthrough for patients and the physicians who care for them. The medical need in this disease remains largely unmet, but we are closer than ever to having additional treatment options.

As a reminder, in November 2023, the principal interim data of ELATIVE® were presented at the AASLD congress . Our partner Ipsen played a key role in this event, with a strong presence at several events aimed at hepatologists from all over the world, who were keen to increase their knowledge of emerging treatment options. These data were also published in the prestigious New England Journal of Medicine.

These results reflect the collective endeavors of GENFIT's teams, and are a source of pride for our employees, whose commitment we applaud. These results also demonstrate our successful partnership with Ipsen, who has now taken over the development of elafibranor. Thanks to Ipsen's commercial expertise, we have every confidence in our partner's ability to capitalize on the years of research and development carried out at GENFIT.

Implications for GENFIT

In	December	2023,	Ipsen's	marketing	payments on elafibranor's cumulative sales, as well
authorization application	filings were	accepted	as a steady stream of royalties on Ipsen's sales of
by three key regulatory bodies: the U.S. Food and	elafibranor. These revenues would contribute to the
Drug Administration (FDA), the European Medicines	financing of our pipeline, which is now mainly focused
Agency (EMA) and the U.K. Medicines and Healthcare	on ACLF.
Products Regulatory Agency (MHRA). In the United
States, the FDA set a PDUFA	for June 10, 2024, which,

if approved, could lead to an almost immediate launch of elafibranor. GENFIT could thus see its first fully in- house-developed molecule made available this year, offering hope to the many patients with PBC, many of whom currently lack effective treatments for their condition.

These advances present GENFIT with new financial perspectives. Following the acceptance of marketing authorization applications in the United States and Europe, which triggered a first milestone payment under the agreement signed with Ipsen in 2021, we expect further payments in 2024, totaling around €89 million . Beyond 2024, successful commercial launches would mean that we would receive further milestone

3 American Association for the Study of Liver Diseases, American learned society in hepatology	...
4 Prescription Drug User Fee Act
5 Including the milestone payment of €13.3 million already received in February 2024), subject to the approval and commercialization of elafibranor in PBC
GENFIT - Newsletter n°16 - May 2024	2

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2.

ACLF : a Franchise Enriched by 2 New Assets in 2023

An urgent medical need

ACLF is the end stage of any progressive liver disease, whatever its initial etiology. Any chronic liver disease - linked to PBC, MASH, viral or drug-induced hepatitis, or excessive alcohol consumption - can lead to ACLF. These diseases cause fibrosis, which can spread and develop into cirrhosis, which is initially "compensated": the liver continues to function despite advanced disease. Then, the disease becomes "decompensated": the liver is no longer able to carry out its functions. It is at this stage that ACLF appears, due to a precipitating factor, such as infection or excessive alcohol consumption. Liver dysfunction leads in turn to the failure of one or more organs, including the kidneys, brain, circulatory and respiratory systems. It's a rare but serious syndrome, with 28-day mortality ranging from 25% to 79%, depending on the number of organs affected.

Excerpt from our ACLF Day, held in Boston during AASLD 2023, where we presented our ACLF strategy.

Increase in mortality with ACLF progression

		28 day mortality
	No ACLF	<5%
1 organ		22%
failure	ACLF Grade 1
2 organ	ACLF Grade 2	32%
failures
3 organ	ACLF Grade 3	77%
failures

There is currently no drug available for the treatment of ACLF. Patients are hospitalized in intensive care, and current management is limited to doing everything possible to maximally support failing organs to bridge patients to liver transplant, the only definitive therapy. Better management is therefore essential, not only for patients and their families, but also for healthcare providers, who have few effective solutions. Above all, there is limited time to effectively treat these patients for whom there is often a very rapid decline in their clinical condition.

Lastly, ACLF has become an essential issue for healthcare systems, with an estimated cost in the United States of $6.4 billion in 2021, almost 4 times more than 10 years ago.

A selective and well-considered choice of therapeutic targets

In response to this urgent situation, GENFIT has decided to build an ACLF franchise to explore different therapeutic pathways.

Since 2022, the Company has developed a rich and diversified pipeline of five drug candidates. The mechanisms of action of the drug candidates that make up this portfolio correspond to different elements of the known pathophysiology of ACLF,

6 Metabolic Associated Steatohepatitis (formerly known as NASH)

which may potentially be complementary. The two latest licensing agreements signed in 2023 were for molecules (SRT-015 and CLM-022) initially developed by US biotechnology companies.

These programs are at different stages of development. We expect our most advanced asset, VS-01, to deliver initial Phase 2 clinical results by the end of this year.

...

GENFIT - Newsletter n°16 - May 2024

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PIPELINE

Preclinical	Phase 1	Phase 2	Phase 3

ACLF

franchise

VS-01

NTZ SRT-015CLM-022VS-02 in HE

AutresCCA indicationsHAC

GNS561

VS-01

PBC

ELAFIBRANOR

Simplified view of our pipeline. The detailed pipeline is available on our website and can be accessed by clicking on this image.

Strenghthened Leadership

As we build this portfolio, we are also strengthening our leadership to ensure that it is not only linked to the number or quality of our programs in development.

To achieve this, we are capitalizing on our experience as a pioneering company in the development of innovative drug candidates to treat some of the liver diseases associated with ACLF (MASH, PBC, PSC, etc.). Over the years, we have developed expertise in preclinical research, and fostered close partnerships with key players in our ecosystem: leading academic institutions, and most recently EF CLIF, an offshoot of EASL, whose reputation in ACLF research extends far beyond Europe; physicians at the cutting edge of knowledge in their field; experts from regulatory agencies in Europe and the United States; and some of the most committed

and influential patient associations, such as the Global Liver Institute (GLI), a key institution dedicated to serving patients suffering from liver disease. We have also developed considerable expertise in the management of international clinical trials.

3.		Beyond ACLF

GENFIT is working on other serious liver diseases, such as Cholangiocarcinoma (CCA), a type of biliary tract cancer representing approximately 15% of all liver tumors and 3% of gastrointestinal cancers. To address the existing medical need in this indication, GENFIT is developing GNS561, for which preliminary Phase 1b data are planned for late 2024.

GENFIT is also developing VS-01 for Urea Cycle Disorders (UCD) and Organic Acidemia (OA) in infants. Pediatric patients are currently transferred to highly specialized tertiary centers, involving dialysis that is often initiated late, with potentially adverse clinical consequences. To

1. European Association for the Study of the Liver, European learned society in hepatology
2. Madrigal's Rezdiffra (approved in March 2024 in the USA)

solve this problem, GENFIT is developing VS-01, with the aim of completing the studies needed to prepare for entry into the clinic in 2024.

Finally, GENFIT remains present in the area of MASH

(formerly NASH), an indication in which its NIS2+® diagnostic technology has been recognized by the scientific and medical community on numerous occasions in recent months. With the launch of the first molecule in this indication, the demand for diagnostics is expected to grow.

...

GENFIT - Newsletter n°16 - May 2024

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Conclusion

We are confident in the potential of our assets, and in our ability to exploit the drivers that have led to our historical success in PBC.

Your participation at the Annual General Meeting will enable the Company to renew any authorizations that may prove necessary to maintain this new momentum over the coming years. Thanks to your support, we can advance our research, develop our partnerships, and maximize the value of our assets. Please find below a reminder of the voting procedure, and we hope to see many of you on May 22.

Pascal Prigent

What to expect in 2024 ? - Key dates to remember

June 10, 2024: FDA "PDUFA date" for elafibranor in PBC

2nd half of 2024: first results from Phase 2 trial evaluating VS-01 in ACLF

End of 2024: interim data from study evaluating GNS-561 in CCA

Further Information

Please take a look at the content available on our website and on our partners' websites:.

PipelineDays

We presented our development strategy to the scientific and financial community. Watch the video on our partner's website.

Ipsen Capital Markets Day

Watch Ipsen's December 2023 presentation detailing their business prospects.

EF CLIFWebsite

Find	out	more	about
EF	CLIF's	work	and
their		commitment	to
advancing	research	in
the	field	of	liver failure.

3D Video

Watch our 3D video detailing the cascade of events triggering ACLF

Corporate Presentation

Read our corporate presentation in English on

our website

GENFIT - Newsletter n°16 - May 2024

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4.

How to vote

Why vote ?

Your presence at the Shareholders Meeting is essential to renew the approvals that are essential for our future momentum. Your support is critical to advancing our

research and strengthening our partnerships. Voting instructions are available below and we look forward to seeing you on May 22.

How to vote

As in previous years, the Annual General Meeting will be held at the Faculty of Pharmaceutical Sciences in Lille at 10 a.m. on first convening. If you are unable to attend the Shareholders' Meeting in person, you can still exercise your rights remotely by voting by mail and, in particular, by Internet via the Votaccess* electronic voting platform (secure website), which will be open from May 3 to May 21 at 3 p.m. (French time). Alternatively, you may express your opinion on the proposed resolutions by mail before the meeting:

by postal vote,

By appointing a proxy to vote on your behalf,

by giving your proxy to the Chairman of the Meeting

To do so, we invite you to read our convening Notice, which is available on our website, and to take the steps described therein as soon as possible so that your instructions can be taken into account.

In the event that the Shareholders Meeting is unable to validly conduct business due to a lack of the quorum required for Shareholders Meetings on convening, the Shareholders Meeting will be reconvened with the same agenda on June 24, 2024, at 2:30 p.m., at the same venue.

You can find all the information

you need about the May 22 Annual General Meeting and how to participate, as well as a tutorial on how to use the Votaccess electronic voting

platform, by clicking here.

A toll-free phone number is also available to answer all questions relating to the voting procedures:

• 0 805 321 079 (France only) or;
• + 33 1 78 90 69 14 (internatnional), Monday to Friday from 10am to 7pm CET

*If your broker has signed up to the platform

GENFIT | [e-mail]| https://ir.genfit.com/

This Shareholders' Letter contains certain forward-looking statements with respect to GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995 in relation to the availability of topline data for UNVEIL-IT® and the clinical trial evaluating GNS561 in CCA, the potential approval by the FDA and other regulatory authorities of elafibranor for the treatment of PBC, the potential to receive milestone payments and royalties subject to the approval and commercialization of elafibranor in PBC, the future and development of NIS2®, TS-01, the commercial prospects for elafibranor and its potential as a therapeutic option for patients, our financial outlook, including cash flow and cash burn projections, and our commercial activity projections for 2024 and thereafter. The use of certain words, including "consider", "contemplate", "think", "aim", "expect", "understand", "should", "aspire", "estimate", "targeted", "anticipated", "believe", "wish", "may", "could", "allow", "seek", "encourage" or "have confidence" or (as the case may be) the negative forms of such terms or any other variant of such terms or other terms similar to them in meaning is intended to identify forward-looking statements. Although the Company believes its projections are based on reasonable expectations and 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 to research and development, including those relating to the safety of drug candidates, the progress, costs and data from planned and ongoing clinical trials, reviews and approvals by regulatory authorities in the United States, Europe and worldwide for drug candidates and diagnostic solutions, the potential commercial success of elafibranor should it be approved by regulatory authorities, exchange rate fluctuations, the Company's ability to continue to raise capital for its 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 2023 Universal Registration Document filed with the AMF on April 5, 2024 under n° D.24-0246, 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 5, 2024. 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

GENFIT - Newsletter n°16 - May 2024

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