The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are:
* Does NTZ treatment of diarrheal Cryptosporidium infection lower the number of days of diarrhea?
* Does NTZ treatment of diarrheal and non-diarrheal Cryptosporidium infection lower the number of days that parasites can be found in the stool?
Researchers will compare NTZ to a placebo (a look-alike substance that contains no drug) to see if NTZ works to treat Cryptosporidium.
Participants will:
* Take NTZ or placebo for 3 days
* Receive regular visits from field research assistants
* Provide blood and urine samples

Start Date01 Apr 2026

Sponsor / Collaborator

Johns Hopkins Bloomberg School of Public Health

[+1]

NCT07110441

/ CompletedPhase 1

A Phase 1, Open Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects

A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects

Start Date26 Aug 2025

Sponsor / Collaborator

Genfit SA

ChiCTR2500108033

/ Not yet recruitingNot ApplicableIIT

Tolizumab (anti-IL-6) in combination with nitazoxanide (anti-Wnt/β-catenin) in the treatment of recurrent or surgical residual enamel cell-type craniopharyngiomas

Start Date01 Aug 2025

Sponsor / Collaborator-

100 Clinical Results associated with Nitazoxanide

100 Translational Medicine associated with Nitazoxanide

100 Patents (Medical) associated with Nitazoxanide

1,305

Literatures (Medical) associated with Nitazoxanide

31 Dec 2026·PHARMACEUTICAL BIOLOGY

Kaempferol activity on Cryptosporidium parvum infection in an experimentally infected immunocompromised mouse model: In silico and in vivo investigations

Article

Author: El-Wakil, Eman S. ; Alsulami, Muslimah N. ; Azab, Haytham ; Wakid, Majed H.

CONTEXT:

No vaccine or effective therapy for cryptosporidiosis currently exists, except for nitazoxanide (NTZ), which has limited effectiveness in immunocompromised hosts. Kaempferol (KPF), a naturally occurring flavonoid, has various pharmacological effects and promising antiparasitic properties.

OBJECTIVE:

The current work aimed to examine the impact of KPF compared with NTZ on Cryptosporidium parvum (C. parvum) using both in silico molecular docking and in vivo studies with an experimentally infected immunocompromised mouse model.

MATERIALS AND METHODS:

The present study utilized KPF and NTZ as multi-target ligands to predict, determine, and evaluate their in silico target-interacted forms, thereby demonstrating their therapeutic properties against C. parvum. Mice were immunosuppressed and divided into six groups: DEXA, Model, KPF as prophylaxis, treatment with KPF, NTZ, and a combination of KPF and NTZ. Treatment efficacy was assessed through parasitological, histopathological examination, and immunohistochemical analysis of intestinal tissues using NLRP3 protein.

RESULTS:

The in silico findings supported the use of KPF and NTZ as inhibitors of C. parvum growth by blocking the action of C. parvum choline and pyruvate kinases. The in vivo study demonstrated that KPF exhibits anti-cryptosporidial efficacy, particularly when combined with NTZ. The KPF+NTZ had the best results, as evidenced by a significant decrease (p < 0.001) in oocyst shedding of 83%, improved intestinal histological damage, and inhibition of the NLRP3 inflammasome pathway.

DISCUSSION AND CONCLUSION:

KPF demonstrated the potential to mitigate the consequences of cryptosporidiosis and serve as an adjuvant agent to NTZ by reducing the oocyst burden, alleviating intestinal inflammation, and facilitating mucosal repair.

01 Apr 2026·EXPERIMENTAL EYE RESEARCH

Therapeutic efficacy of nitazoxanide on Acanthamoeba keratitis in an experimental model

Article

Author: Fahmy, Iman A ; Zoghroban, Hager S ; Shakour, Toqa Yasser ; Eid, Asmaa M ; Othman, Ahmad A ; Ali, Ahmed Yousef Amin ; El-Wakil, Eman S

Acanthamoeba keratitis (AK) is a serious sight-threatening infection caused by various species of the opportunistic protozoan Acanthamoeba, especially in contact lens wearers and immunocompromised people. The aim of the study was to assess the therapeutic efficacy of two topical nitazoxanide (NTZ) formulations in experimentally induced AK. Three groups of male New Zealand white rabbits were used: group (A): infected and received NTZ in suspension form; group (B): infected and received NTZ in liquid crystal forming system; and group (C): infected and received topical chlorhexidine 0.02 %. The right eyes of the animals served as their corresponding infected untreated control. The animals were infected by Acanthamoeba isolated from human cases of AK. The effects of treatment were assessed over 30 days through daily clinical evaluation; grading of AK; and parasitological and histopathological examination of corneal tissues. The present work revealed that after inducing keratitis, signs of infection appeared on day 3, and all groups showed similar infection rates before treatment began. Corneal opacity improved significantly in animals treated by NTZ liquid crystal form, especially by days 18-30 post-treatment, scoring therapeutic outcomes comparable or superior to the chlorhexidine-treated group and markedly better than the NTZ suspension-treated group. Histopathological assessment confirmed these findings, with the NTZ liquid crystal group exhibiting minimal inflammation and no detectable cysts, highlighting its potential as an effective alternative agent against Acanthamoeba. In conclusion, NTZ in its liquid crystal form showed promise as a potential therapy for AK. Further studies are needed to establish safety and efficacy of topical NTZ in humans and its possible use in combination with other amoebicidal agents.

01 Feb 2026·IUBMB LIFE

ADAM15 Is a Potential Biomarker for Pan‐Cancer Prognosis and Immunotherapy: Validation in HCC and COAD

Article

Author: Chen, Bingdi ; Wang, Jinghan ; Liu, Yu’e ; Guo, Wenjia ; Fan, Lieying ; Ma, Wencong

ABSTRACT:

A Disintegrin and metalloprotease (ADAM) family encompasses a diverse array of widely expressed proteases functioning in pathological processes. ADAM15 stands out as a pivotal mediator in multiple tumor types, responding to immune checkpoint inhibitors (ICI) significantly. By promoting pro‐angiogenic genes, potentiating integrin binding as well as modulating the inflammatory response, ADAM15 orchestrates cellular adhesion and migration, thereby fostering tumor progression. Despite these compelling insights, the intricate roles of ADAM15 in prediction, immune modulation, and therapeutic targeting among malignant disorders remain largely unexplored. To decipher the pan‐cancer landscape of ADAM15, we integrated data from multiple databases. Immunohistochemical profiles of ADAM15 were retrieved from the human protein atlas (HPA) database. Furthermore, the tumor immune estimation resource (TIMER) and the ESTIMATE (Estimation of Stromal and Immune cells in Malignant Tumor tissues using Expression data) algorithm were harnessed to dissect the immune infiltration patterns and immune checkpoint genes associated with ADAM15. The tumor immune single‐sample gene set enrichment analysis (TISMO) was employed to explore the impact of ADAM15 on the tumor immune microenvironment. Additionally, drug sensitivity analysis and subsequent molecular docking studies were conducted to identify potential therapeutic compounds targeting ADAM15. These findings were rigorously validated through reverse transcription‐polymerase chain reaction (RT‐PCR), western blotting (WB), and immunohistochemistry (IHC) by cell lines and clinical samples from hepatocellular carcinoma (HCC) as well as colon adenocarcinoma (COAD). Our comprehensive analysis revealed that ADAM15 is markedly upregulated in diverse cancer types. IHC, WB, and RT‐PCR assays of HCC and COAD confirmed these findings. Notably, elevated ADAM15 correlates with adverse prognosis in pan‐cancer, positioning it as a promising novel biomarker. Drug sensitivity profiling unveiled a positive and statistically significant association between ADAM15 and AZD‐8055 and Nitazoxanide, whereas a negative correlation was observed with Oxaliplatin and Ponatinib. These findings were further corroborated by molecular docking simulations, highlighting the potential of these compounds as therapeutic targets for ADAM15‐driven cancers. Our study underscores the multifaceted role of ADAM15 in cancer progression, immune evasion, and response to therapy. By elucidating the intricate interplay between ADAM15 and the tumor microenvironment (TME), we have identified novel diagnostic biomarkers and potential therapeutic avenues.

News (Medical) associated with Nitazoxanide

26 Feb 2026

·ir.genfit.com

GENFIT Reports Fourth Quarter 2025 Financial Information and Provides a Corporate Update

Cash and cash equivalents totaled €101.1 million as of December 31, 2025 Revenues amounted to €65.4 million as of December 31, 2025 Ipsen’s strong performance with Iqirvo® in PBC (>$200M net sales in year one) triggered GENFIT’s €17.0 million ($20.0 million) milestone, included in reported revenues, but not yet reflected in the cash position ACLF and CCA programs progressing according to plan Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 26, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces its fourth quarter 2025 revenues and cash position results1 and provides a corporate update. I. Cash position As of December 31, 2025, the Company’s cash and cash equivalents amounted to €101.1 million compared with €81.8 million as of December 31, 2024 and €119.0 million as of September 30, 2025. In 2025, cash utilization is mainly the result of our research and development efforts in our Acute on-Chronic Liver Failure (ACLF) franchise (notably VS-01, NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €26.55 million milestone received in July 2025 (invoiced in May 2025) upon pricing and reimbursement approval of Iqirvo® (elafibranor) in Italy, the third major European country to do so, as part of our long-term strategic partnership with Ipsen (the “Ipsen Agreement”) signed in December 2021. In January 2026, GENFIT exercised its option to receive (and did in fact receive) the second installment of the Royalty Financing agreement totaling €30.0 million. Both this amount, as well as the first commercial milestone of €17.0 million ($20.0 million) that GENFIT will receive as part of the Ipsen Agreement, are not included in cash and cash equivalents as of December 31, 2025. We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the end of 2028, enabling the Company to further develop its R&D pipeline focused on ACLF and support general corporate purposes. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes (i) our expectation to receive significant future commercial milestone revenue pursuant to the Ipsen Agreement and Ipsen meeting its sales-based thresholds and (ii) drawing down the third and final, optional installment under the Royalty Financing agreement. RevenueRevenues for 2025 amounted to €65.4 million compared to €67.0 million for the same period in 2024. Royalty revenue is entirely attributable to worldwide sales of Iqirvo® (elafibranor), which amounted to $208 million in 2025. Milestone revenue in 2025 is comprised of two milestones: GENFIT’s first commercial milestone of €17.0 million ($20.0 million) after Ipsen’s Iqirvo® exceeded the $200 million threshold in its first full year of net sales, and GENFIT’s milestone of €26.55 million upon pricing and reimbursement approval of Iqirvo® (elafibranor) in Italy, the third major European country to do so. II. Corporate update and program highlights Acute On-Chronic Liver Failure (ACLF) The key highlight for this pipeline segment in the fourth quarter 2025 was the progress of our lead program, G1090N, which generated preliminary Phase 1 data readout showing a safety profile and a robust anti-Inflammatory activity evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors. As communicated earlier, GENFIT will engage with regulatory authorities to determine the best approach for progressing to a Phase 2 proof-of-concept in inflammatory conditions such as ACLF, where systemic immune dysregulation is a critical driver of disease progression. Other assets developed to address the unmet medical need in ACLF continued their preclinical evaluation during the fourth quarter of 2025 to fully assess their potential before advancing into clinical development. Cholangiocarcinoma (CCA) The main highlight in this indication in the fourth quarter of 2025 was the highly encouraging early data delivered from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers. Phase 1b dose escalation continues as planned to confirm the activity signal, with new data for next patient cohorts and recommended Phase 2 combination doses expected in the first half of 2026. Phase 2 initiation remains targeted for the second half of 2026. Ipsen’s Iqirvo® (elafibranor) in Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC) PBC: Iqirvo®’s net sales for the fourth quarter 2025 amounted to $88 million, bringing full-year 2025 sales to $208 million, triggering the first commercial milestone payment to GENFIT one year ahead of schedule. PSC: Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial, addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo® ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties. END 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 focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.2 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (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 with respect to GENFIT, including, but not limited to, statements about the Company’s cash runway and the development of its clinical and preclinical programs, to the timelines for obtaining results from ongoing studies and initiating upcoming studies, to upcoming discussions with regulatory authorities, to the potential regulatory approval of its product candidates, and to the projected sales of Iqirvo® in PSC should it be approved for this indication. 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 non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, 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 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) 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 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 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 | InvestorsJean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com GENFIT | MediaBruno ARABIAN – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 Unaudited financial information under IFRS2 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® Attachment GENFIT Reports Fourth Quarter 2025 Financial Information and Provides a Corporate Update

Phase 2Phase 1Financial StatementLicense out/inAcquisition

12 Feb 2026

·www.biospace.com

GENFIT to receive US$20M milestone after Ipsen’s Iqirvo® exceeds the US$200M threshold in its first full year of net sales

Ipsen reported US$88M of Iqirvo® net sales in PBC for 4Q25, bringing 2025 sales to US$208M, triggering the first commercial milestone payment to GENFIT ahead of schedule 1 Ipsen confirmed its commitment to launch a Phase 3 in PSC, creating a new avenue for potential future upside for GENFIT GENFIT’s CCA Phase 1b study progressing as planned: New dose-escalation cohort fully enrolled with no dose-limiting toxicities reported at the 21-day timepoint Phase 1b data readout and recommended Phase 2 doses remain on track for 1H26 Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 12, 2026 - GENFIT (Euronext: GNFT) , a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the strong commercial performance of Iqirvo® in its first full year on the primary biliary cholangitis (PBC) market has triggered a US$20M milestone payment from Ipsen under the companies’ licensing agreement. The commercial success of Iqirvo® in 2025 underscores the strength of our partnership with Ipsen and exceeded our initial expectations with first-year net sales reaching US$208M. This performance activated a US$20M milestone payment ahead of plan, reinforcing GENFIT’s financial position. This momentum also led to the receipt of an additional €30M tranche under GENFIT’s royalty‑financing agreement with HCRx, enhancing financial flexibility in a non-dilutive way. In parallel, Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial in primary sclerosing cholangitis (PSC), addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo® ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties. Beyond Iqirvo®, GENFIT continues to advance its oncology program. The ongoing Phase 1b study in cholangiocarcinoma (CCA), evaluating GNS561 in combination with a MEK inhibitor, is progressing in line with expectations. As communicated in December 2025, early positive activity was observed in the first evaluable patients at Week 6. Enrollment for a the next escalated-dose cohort has now been completed, with no dose-limiting toxicities (DLTs) reported to date. Recruitment for the following one will now proceed, consistent with the predefined dose‑escalation process. Multi-cohort readouts on safety, tolerability and activity along with the determination of the recommended Phase 2 doses remain expected by the end of the first half of 2026. Pascal Prigent, CEO of GENFIT declared: “We are pleased with Ipsen’s continued success with Iqirvo®. Net sales have surpassed US$200M in 2025 and this remarkable performance has allowed us to get the first commercial milestone a year earlier than anticipated. We believe that this commercial trajectory has the potential to be transformative for our business model. We are also pleased with the progress of our GNS561 program, with a new cohort fully recruited. This program might bring significant hope for patients with a devastating disease, and we are eagerly awaiting new data. As we are also anticipating the first ACLF patients to be included in a phase 2 evaluating G1090N in the second half of the year we believe 2026 will be a landmark year for GENFIT.” GENFIT will publish its 4Q25 revenue and cash position on February 26, 2026. All details from Ipsen’s communication are available here: END 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 focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries. 2 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements about the future commercial trajectory of Iqirvo® in PBC, the ability to obtain marketing authorization for elafibranor in PSC, the potential to receive future milestone payments and royalties under the Ipsen agreement, the timing, progression and expected data readouts of GENFIT’s ongoing clinical programs such as the Phase 1b study in cholangiocarcinoma and the planned Phase 2 study of G1090N in ACLF, and more generally GENFIT’s expectations regarding its financial position, strategic outlook and prospects for 2026 and beyond. 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 non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, 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 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website ( ) and the AMF's website ( ), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2025, 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 Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com GENFIT | Media Bruno Arabian – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | 1 Based on contractual change rates (€76,6M sales in 4Q25 and €184M annual sales in 2025) 2 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® . Attachment GENFIT to receive US$20M milestone after Ipsen’s Iqirvo® exceeds the US$200M threshold in its first full year of net sales

Phase 2Phase 1Drug ApprovalLicense out/in

06 Jan 2026

·ir.genfit.com

GENFIT: Favorable Phase 1 Safety Profile and Strong Anti-Inflammatory Activity for ACLF Lead Asset G1090N

Phase 1 results confirm investigational drug-candidate G1090N has a favorable safety and tolerability profile, supporting further clinical evaluation Compelling anti-inflammatory activity of G1090N was evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors, showing inhibition of pro-inflammatory pathway Findings provide a solid foundation for advancing G1090N into Phase 2 proof-of-concept studies across the ACLF continuum Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), January 6, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that G1090N – a small molecule and the Company’s lead investigational drug candidate for Acute-On-Chronic Liver Failure (ACLF) – demonstrated a favorable Phase 1 safety profile, and a strong anti-inflammatory activity in ex-vivo studies. Dr. Jacqueline O’Leary, MD at the UT Southwestern Medical Center, Dallas, TX (USA), commented: “The safety profile observed in Phase 1 and the consistent biological activity evidenced in ex vivo assays represent a meaningful step in development. These findings position G1090N as a promising candidate for patients with acute decompensation and for patients with ACLF, a life-threatening condition with no approved therapies and significant unmet medical need. We are eager to see more patient data as the program moves forward, to confirm G1090N’s safety and strengthen the case for its activity in patients with organ failure.” Phase 1 The Phase 1, open-label trial assessed the safety, tolerability and pharmacokinetics (PK) of G1090N in healthy volunteers following a Single Ascending Dose administration (SAD) phase, and a Multiple Ascending Dose administration (MAD) phase. 13 healthy volunteers were enrolled in each segment, with a total of 76 participants. G1090N’s safety profile observed in healthy volunteers supports continued evaluation. Ex vivo studiesGENFIT evaluated the modulation of inflammation-related signaling pathways in ex vivo pharmacodynamic and proof-of-efficacy assays: G1090N demonstrated robust biological activity in peripheral blood mononuclear cells (PBMC) assays from healthy volunteers using blood samples from Phase 1 study participants, on LPS-induced IL-6 and TNFα cytokines production, with up to 76% statistically significant inhibition (p<0.0001); The bioactive metabolite of G1090N confirmed its anti-inflammatory potential on ex vivo assays performed on blood collected from cirrhotic donors. These findings indicate that G1090N: Displays strong anti-inflammatory activity at the doses tested in the first-in-human study Effectively engages its target mechanism of action in circulating immune cells Modulates key pathways driving systemic inflammation, a major contributor to acute decompensated cirrhosis with or without ACLF. Next stepsThese results support further clinical development of G1090N. GENFIT will engage with regulatory authorities, including the U.S. Food and Drug Administration, to determine the best approach for progressing to Phase 2 proof-of-concept in inflammatory conditions such as ACLF where systemic immune dysregulation is a critical driver of disease progression. END 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 focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.1 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (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 STATEMENTSThis press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements about the future development of G1090N, including plans to advance into Phase 2 proof-of-concept studies, anticipated regulatory interactions, potential therapeutic benefits in ACLF and related conditions, and the expected progression of GENFIT’s research and development programs. 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 non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, 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 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.com) and the AMF's website (bdif.amf-france.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2025, 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 Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com GENFIT | Media Bruno Arabian – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.frStephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® . Attachment GENFIT : Favorable Phase 1 Safety Profile and Strong Anti-Inflammatory Activity for ACLF Lead Asset G1090N

Clinical ResultPhase 1

100 Deals associated with Nitazoxanide

External Link

KEGG	Wiki	ATC	Drug Bank
D02486	Nitazoxanide	P01AX11	DB00507

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cryptosporidiosis	United States	Romark, L.C.	22 Nov 2002
Diarrhea	United States	Romark, L.C.	22 Nov 2002
Giardiasis	United States	Romark, L.C.	22 Nov 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Post Acute COVID 19 Syndrome	Phase 3	United States	Romark, L.C.	13 May 2020
COVID-19	Phase 3	United States	Romark, L.C.	12 May 2020
Viral respiratory infection	Phase 3	United States	Romark, L.C.	12 May 2020
Common Cold	Phase 3	United States	Romark, L.C.	11 Sep 2018
Enterovirus Infections	Phase 3	United States	Romark, L.C.	11 Sep 2018
Rhinovirus infection	Phase 3	United States	Romark, L.C.	11 Sep 2018
Influenza B virus infection	Phase 3	United States	Romark, L.C.	01 Mar 2013
Influenza B virus infection	Phase 3	Australia	Romark, L.C.	01 Mar 2013
Influenza B virus infection	Phase 3	Belgium	Romark, L.C.	01 Mar 2013
Influenza B virus infection	Phase 3	Canada	Romark, L.C.	01 Mar 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07110441 (Company_Website) Manual	Phase 1	-	76	G1090N	sbpvjlfwbg(wnbvogyczl) = favorable safety and tolerability profile, supporting further clinical evaluation zrnbzxxtba (kkkjkstece ) View more	Positive	06 Jan 2026
NCT04532931 (CTgov)	Phase 2	COVID-19	192	SOC+Paracetamol (SOC) (Arm A)	sfsxipqpag = wfoknbygys vaxccwnuye (vyklxdqowk, wuqkmkpmbd - pnfremofwj) View more	-	28 Jul 2025
				Artesunate+Amodiaquine (Arm B)	sfsxipqpag = vnyaoenixf vaxccwnuye (vyklxdqowk, nrpvdpiejp - upxndtqsiv) View more
NCT04489381 (CTgov)	Phase 3	Rhinovirus infection \| Common Cold \| Enterovirus Infections	214	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	uodfuwtegl(eosbdjtoor) = ssszjwpjxv uojztyxpdi (okkmleibnt, xzpqzhgqem - rlhgwmzexi) View more	-	17 Oct 2024
				Placebo (Placebo)	uodfuwtegl(eosbdjtoor) = fbxpefyszj uojztyxpdi (okkmleibnt, dzuvqeiosy - bvwpwdhxmq) View more
UEGW2024	Not Applicable	Infectious Diseases	-	Levofloxacin, nitazoxanide, doxycycline, and lansoprazole (LNDL)	dktcgiuajl(smnqvoqbjx) = iivnlsfuus djqkbmakod (ywlvjaijwp, 75.73 - 91.27)	-	13 Oct 2024
				Moxifloxacin, nitazoxanide, doxycycline, and lansoprazole (MNDL)	dktcgiuajl(smnqvoqbjx) = ibmmgkyrsp djqkbmakod (ywlvjaijwp, 73.57 - 90.01)
NCT04343248 (CTgov)	Phase 3	COVID-19 \| Viral respiratory infection	190	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	jilokfzdic = mbikrnvfpt cbzyulsgtj (krupljlvgq, oonrccaxie - rnewzuwext) View more	-	08 Jul 2024
				Placebo (Placebo)	jilokfzdic = nhogpgnefz cbzyulsgtj (krupljlvgq, bvvqxaxuei - yolifmzvtd) View more
NCT04359680 (CTgov)	Phase 3	COVID-19 \| Post Acute COVID 19 Syndrome \| Viral respiratory infection	1,407	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	xohfulzvvy = uzckzfmhou yjchzchegh (cqmtsqbbay, jckcszbikh - huxdemwtwl) View more	-	26 Jun 2024
				Placebo (Placebo)	xohfulzvvy = bawqtodmej yjchzchegh (cqmtsqbbay, ytxfwkqscm - ikmferbaxy) View more
NCT04486313 (CTgov)	Phase 3	COVID-19	935	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	bnwigpupda(paxovhggpt) = etijxlykgy oysqojrhet (sfczrapnzv, mfksugkgyo - jtlycxtqfa) View more	-	29 Mar 2024
				Placebo (Placebo)	bnwigpupda(paxovhggpt) = gclpvdmikh oysqojrhet (sfczrapnzv, ghysmcteuv - mrjnjrbezk) View more
NCT03905655 (CTgov)	Phase 2	Hepatitis B, Chronic	51	Placebo Oral Tablet (Group 1)	ilcjwbtwqd(mukgtndpdz) = qcqticagiq effgssbcra (watznssiop, 0.13) View more	-	07 Nov 2023
				Placebo Oral Tablet+Nitazoxanide (Group 2)	ilcjwbtwqd(mukgtndpdz) = lwkzwexomi effgssbcra (watznssiop, 0.90) View more
NCT03395405 (CTgov)	Phase 2	Gastroenteritis	31	Nitazoxanide (Nitazoxanide (500 mg))	tevhnigjlp(duuphlinni) = fxuxlrscbn cmgyjwtkbu (dbtedhatqu, mtixkmemdx - tqvpdovibn) View more	-	24 Oct 2022
				placebo (Placebo)	tevhnigjlp(duuphlinni) = ozgvrqgrzg cmgyjwtkbu (dbtedhatqu, hqicgpywhr - nhztvmdrhx) View more
NCT03656068 (CTgov)	Phase 2	Fibrosis, Liver \| Metabolic Dysfunction Associated Steatohepatitis \| Compensated cirrhosis	21	NTZ	cyyttlhqvq = irfttztypj udycpnyoqj (olmflqvxhf, avdsczimzc - sakjtltorp) View more	-	30 Jun 2022

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