On April 2, 2026 GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported annual financial results for the year ended December 31, 2025 and provided a corporate update. A summary of the consolidated financial statements is included below.
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Pascal Prigent, CEO of GENFIT commented: "Iqirvo’s performance in its first full year of sales, together with encouraging early results from both our oncology and ACLF assets, were very promising signs for GENFIT last year. 2026 could be even better and significantly accelerate the Company’s trajectory. Indeed, we expect to see continued strong performance from Iqirvo in PBC, while also anticipating a significant acceleration in our diagnostic business. On top of these growing businesses, there are also promising programs further down the pipeline. This summer, we expect to receive full results from our Phase 1b oncology trial, which could become a game changer. In 2027, we anticipate results from the Phase 2 proof‑of‑concept study evaluating NTZ in ACLF that we will start later this year. Looking further ahead, Ipsen’s ongoing development efforts in PSC also have the potential to represent a step change for the Company."
In 2025, GENFIT benefited from the strong commercial performance of Iqirvo1 in Primary Biliary Cholangitis (PBC), driven by Ipsen’s commercial execution. Performance will continue to be closely monitored, and current indicators suggest that Ipsen is on track to deliver results meaningfully above initial expectations. Beyond this existing business, several additional programs in our pipeline or with partners have the potential to generate additional significant value in the future on a scale comparable to, or exceeding, PBC royalties:
In metabolic dysfunction‑associated steatohepatitis (MASH), GENFIT’s diagnostic technology targets a very large and rapidly expanding market, supported by accelerating therapeutic development and deepening engagement from major industry players. In this context, our non-invasive technology is recognized as a critical component of this evolving ecosystem. We believe that the potential royalties deriving from our technology could be very significant. Key catalysts will be reimbursement status and industry partnerships, with multiple initiatives currently underway to drive broader deployment.
In oncology, new Phase 1b clinical data from the GNS561 combination in cholangiocarcinoma (CCA) are expected mid‑year and should provide important insights to inform further development and support progression toward Phase 2.
In Acute-on-Chronic Liver Failure (ACLF), a Phase 2 study evaluating NTZ is expected to start in the second half of this year, marking a significant step forward in this indication.
Finally, in PSC, a market comparable in size to PBC, Ipsen has initiated a Phase 3 study called ELASCOPE2 in February 2026, and currently is the sole company at this stage of development in PSC.
I. 2025 Highlights – including post-closing events
Commercial & partnership highlights
In 2025, GENFIT’s partners achieved significant progress, driving a number of important developments across key programs:
Ipsen’s Iqirvo (elafibranor) in PBC and PSC
PBC: Iqirvo’s net sales for the fourth quarter 2025 amounted to US$88 million, bringing full-year 2025 sales to US$208 million3, triggering the first US$20M commercial milestone payment to GENFIT one year ahead of schedule. This momentum also allowed GENFIT to activate, in January 2026, an additional €30 million tranche under GENFIT’s royalty‑financing agreement with HCRx, enhancing financial flexibility without shareholder dilution.
PSC: Ipsen initiated 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.
Following the mutual termination of GENFIT’s agreement with Terns in December 2025, Ipsen exercised its contractual opt‑in right to include Greater China in the existing Licensing Agreement, resulting in a worldwide elafibranor license for Ipsen under the same favorable financial terms.
Non-invasive diagnostic technology in MASH
The MASH therapeutics market accelerated in 2025, with near‑blockbuster performance (~US$1 billion in sales) achieved by the first approved therapy in its first year of commercialization, increasing the need for large‑scale, non‑invasive diagnostic, further reinforced by the entry of an additional major therapeutic player in August. Against this backdrop, pricing for NASHnext—developed by Labcorp as a Laboratory Development Test (LDT) under license from GENFIT and based on GENFIT’s proprietary non‑invasive diagnostic technology for identifying at‑risk patients in MASH (formerly NASH)—, was established by U.S. Medicare and Medicaid at the end of 2025. This represents an important step toward reimbursement.
R&D highlights
In 2025, GENFIT advanced its lead clinical programs in ACLF and CCA, reprioritized VS‑01, and continued to assess the potential of multiple mechanisms of action across its research portfolio.
Clinical developments
G1090N/NTZ (ACLF): Our lead program generated preliminary Phase 1 data showing a favorable safety profile and a robust anti-inflammatory activity evidenced through functional ex vivo assays on blood samples from study participants and from cirrhotic donors.
GNS561 (CCA): Encouraging preliminary data were generated 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.
VS-01 (ACLF): GENFIT decided to discontinue this program in ACLF, following the emergence of a safety signal, prompting a precautionary reassessment of the benefit/risk ratio in this indication, and refocused development in Urea Cycle Disorder (UCD) where the disease biology, patient population and development framework materially differ.
Research developments
SRT–015 (ACLF): Although activity on the ASK1 target has been demonstrated in preclinical models, the in vivo data available to date do not confirm a sufficient benefit, and uncertainties remain regarding the expected effects in ACLF.
CLM–022 (ACLF): Alongside preclinical studies, GENFIT pursued the activities preliminary to clinical development, including pharmacokinetic and nonclinical safety characterization. While the NLRP3 target remains valid, developability challenges with CLM-022 have been identified and will be further assessed.
VS-02-HE (ACLF continuum): VS‑02‑HE is being optimized as an oral formulation designed to act at the colonic level, where ammonia is primarily produced, to minimize its systemic concentration while reducing glutamine levels in the brain. In the first quarter of 2026, regulatory toxicology studies were initiated.
EViv (ACLF): At the end of 2025, GENFIT initiated a research collaboration with EverZom aimed at evaluating the therapeutic potential of extracellular vesicles derived from human adipose‑derived mesenchymal stem cells (hAD‑MSC‑EVs) in Acute Decompensation (AD) and ACLF.
VS-01-HAC (UCD): VS01 was reprioritized to Urea Cycle Disorders (UCD) following the discontinuation of the ACLF program. Positive initial data from a pivotal juvenile toxicology study in Göttingen minipigs supported the tolerability of the compound. VS-01-HAC was granted Rare Pediatric Disease Designation by the FDA for UCD, potentially enabling eligibility for a Priority Review Voucher upon New Drug Application approval.
Other developments
In 2025, GENFIT contributed to positioning ACLF as a strategic focus within the Forum for Collaborative Research, an independent multi‑stakeholder initiative bringing together regulators, industry leaders, academics, clinicians, scientists and patient groups to help shape and accelerate drug development in areas of high unmet medical need.
Financial highlights
The Royalty Financing agreement signed in March 20254 has significantly extended GENFIT’s cash runway, beyond the end of 2028, enabling the Company to further develop its pipeline focused on ACLF and support general corporate purposes. See III. Financial results for further details.
Genfit recorded a revenue of €65.4 million in 2025. This consists of greater than expected royalty revenue of €21.8 million and two milestones totalling €43.6 million, both of which stem from positive market performance of Ipsen’s Iqirvo.
For the year ended December 31, 2025, the Company’s net loss amounted to €86.0 million compared with a net gain of €1.5 million for the year ended December 31, 2024.
Excluding certain one‑time non‑cash operating expenses of €49.1 million, and excluding an estimated €13.3 million in financial expenses arising from faster than expected repayment of the royalty financing, the 2025 net loss would be reduced to €23.6 million. These items are described in more detail below in section III. Financial Results.
Sustainability highlights
B Corp certification was granted at the end of 2025, providing an independent, internationally recognized mark of credibility. This certification underscores GENFIT’s engagement in social, societal, environmental and governance matters as the Company continues to execute its ESG roadmap on schedule.
Corporate governance updates
Mr. Tristan IMBERT was appointed as a director for a three-year term by the General Meeting of Shareholders held on June 17, 2025 and joined the Audit Committee and ESG Committee following his appointment. The terms of office of Mr. Eric BACLET and Ms. Katherine KALIN as directors were renewed for a period of three years. Mr. John BROZEK replaced Ms. Florence SÉJOURNÉ as permanent representative of Biotech Avenir SAS on the Company’s Board of Directors. Dr. Pejvack MOTLAGH replaced Dr. Carol ADDY as Chief Medical Officer and member of the Executive Committee in November 2025, following her retirement on June 30, 2025. Sakina SAYAH-JEANNE, formerly Executive Vice President of Research and Translational Science and member of the Executive Committee, replaced Dean HUM, Chief Scientific Officer following his retirement on September 30, 2025.
II. 2026 Outlook
Commercial and partnership outlook
Ipsen’s Iqirvo (elafibranor) in PBC and PSC
Ipsen is expected to publish its first‑quarter 2026 financial results on April 23, 2026. For further information on the development of Iqirvo in PBC and PSC, please refer to Ipsen’s news flow and financial calendar: View Source
Non-invasive diagnostic technology in MASH
Building on the therapeutic market momentum observed in 2025, and the expected evolution of the competitive landscape with the entry of additional large pharmaceutical players, the MASH diagnostics market is expected to further develop in 2026. Addressing this opportunity at scale will require reliable and scalable solutions to support patient identification, treatment decision‑making and longitudinal monitoring across care pathways. In this context, GENFIT’s technology is already referenced in international clinical guidance as the only fully blood‑based approach for identifying at‑risk MASH patients, recognized by the LITMUS and NIMBLE consortia and supported by a robust body of scientific literature. Looking ahead, further progress in 2026 will depend on a combination of factors, including reimbursement and payer adoption, demand generated through broad pharmaceutical programs, and advances toward an IVD‑labeled version to support wider clinical use.
R&D outlook
Clinical outlook
G1090N/NTZ (ACLF): GENFIT will engage with regulatory authorities, including the U.S. Food and Drug Administration (FDA), 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. Initiation remains targeted for the second half of 2026, with data expected in 2027. In March 2026, Orphan Drug Designation (ODD) was granted for NTZ for the treatment of ACLF.
GNS561 (CCA): Phase 1b dose escalation is progressing as planned, with additional cohort data expected in mid‑2026. The Phase 1 study is designed to assess safety, define the recommended Phase 2 doses for the combination, and evaluate preliminary signs of activity. Initiation of Phase 2 remains targeted for the second half of 2026. In parallel, GENFIT will investigate the biological rationale for autophagy inhibition in the emergence of resistance to standards of care. These studies will aim to assess the therapeutic potential of new combination strategies, associating GNS561 with other agents.
Research outlook
SRT-015 (ACLF): Current work focuses on finishing the preclinical activities to decide by the end of the first semester of 2026 if we move the program into a first‑in‑human clinical trial.
CLM-022 (ACLF): Ongoing work aims to strengthen the translational rationale for NLRP3 inhibition in the indications of AD and ACLF.
VS-02-HE (ACLF continuum): Pharmacological studies are ongoing, and the regulatory toxicology studies are expected to be completed by early 2027. Subject to confirmation, a first‑in‑human trial could be launched in the second half of 2027.
EViv (ACLF): GENFIT and EVerZom plan to conduct exploratory studies to evaluate the efficacy of EViv in ACLF, with a decision point targeted mid-2027 on whether to advance into clinical development.
VS-01-HAC (UCD): A plan of action is currently executed, aimed at securing the developability of VS‑01 in UCD, before potentially initiating a first clinical trial.
Other developments
In May 2026, ahead of its annual congress, the European Association for the Study of the Liver (EASL) will bring together leading international learned societies, spanning North America, Asia‑Pacific, Latin America and Africa, represented by AASLD5, APASL6, ALEH7 and SOLDA8, to jointly address ACLF. This pre‑congress program sends a strong signal for patients, healthcare providers and industrial stakeholders, underscoring growing alignment and momentum across the global hepatology community.
(Press release, Genfit, APR 2, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-full-year-2025-financial-results-and-provides [SID1234664148])