On May 21, 2026 GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its cash position as of March 31, 2026 and revenues for the first three months of 20261 and provides a corporate update.

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Cash Position & Revenues
Cash position

As of March 31, 2026, the Company’s cash and cash equivalents amounted to €136.1 million compared with €129.5 million as of March 31, 2025, and €101.1 million as of December 31, 2025. In 2026, cash utilization is mainly the result of our research and development efforts (notably NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE in Acute on-Chronic Liver Failure), as well as GNS561 in Cholangiocarcinoma (CCA). Cash utilization is offset by two items received in the first quarter of 2026 – the €17.0 million (US$20.0 million) first commercial milestone recognized at the end of 2025 and collected in early 2026 under the Ipsen Agreement, and the €30.0 million second installment of the Royalty Financing agreement. 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 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.

Revenue

Revenue2 for the first three months of 2026 amounted to €9.6 million compared to €2.8 million for the same period in 2025. Revenue for the first three months of both periods was attributable to royalties from sales of Iqirvo3 (elafibranor) from Ipsen.

II. Corporate update and program highlights

The Company confirms previous timelines across all growth platforms.

Ipsen’s Iqirvo (elafibranor) in Primary Biliary Cholangitis (PBC) 4

The strong commercial sales trajectory reported by our partner Ipsen in the first quarter of 2026 is explained by accelerated sales growth in the US driven by a higher number of patients, and strong launches across European countries. Iqirvo’s net sales for the first quarter of 2026 amounted to €78.8m. Full-year 2025 sales amounted to US$208 million, triggering the first US$20 million 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.

Next steps: On July 30, 2026, Ipsen will publish its sales results for the first semester of 2026. Ipsen confirmed ELSPIRE Phase 3 study readout by end of 2026.

Non-invasive diagnostic technology in Metabolic dysfunction‑Associated SteatoHepatitis (MASH)

The MASH therapeutics market accelerated in 2025, with near blockbuster performance (~US$1 billion in sales) achieved by the first approved drug 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 pharmaceutical company in August. Against this backdrop, U.S. Medicare and Medicaid have taken an initial step by establishing a pricing framework for NASHnext. NASHnext is a diagnostic test developed and commercialized by Labcorp as a Laboratory Developed Test (LDT) under license from GENFIT. It leverages GENFIT’s proprietary non-invasive diagnostic technology to identify patients at risk of progressive MASH and support treatment decision-making. This represents an important progress toward potential reimbursement and broader payer adoption, supported by Labcorp’s US commercial infrastructure.

Next steps: A commercial launch by Labcorp is expected in the coming weeks, with initial access to NASHnext enabled through Labcorp’s on-demand test menu, marking the start of a phased expansion beyond the current clinical trial setting. This rollout is already accelerating, notably in anticipation of upcoming reimbursement. GENFIT plans to host an analyst event to present recent publications demonstrating the clinical utility of its non-invasive (NIS) technology, outline its strategy in MASH diagnostics — including its In Vitro Diagnostics (IVD) approach — and provide a detailed overview of the MASH diagnostics market potential.

Clinical development of GNS561 in Cholangiocarcinoma (CCA)

Following encouraging preliminary data from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, the Phase 1b dose escalation is progressing as planned.

Next steps: Phase 1b safety data from initial cohorts expected in mid 2026, as planned. Additional data anticipated in the second half of 2026, following study expansion into additional cohorts supported by encouraging preliminary signals.

Clinical development of G1090N/NTZ in Acute-on-Chronic Liver Failure (ACLF)

Positive Phase 1 data reported in early 2026 confirmed the favorable safety profile of G1090N/nitazoxanide (NTZ) and demonstrated multi‑modal biological activity, supporting its continued clinical development across the ACLF disease continuum. In March 2026, NTZ was granted Orphan Drug Designation for the treatment of ACLF.

Next steps: Initiation of a proof‑of‑concept study with nitazoxanide targeted for the second half of 2026, with data expected in 2027.

Ipsen’s elafibranor lifecycle: important potential in PSC (Primary Sclerosing Cholangitis)4

In early 2026, Ipsen announced the initiation of the Phase 3 ELASCOPE study in PSC. The PSC market opportunity is estimated to be comparable in size to the second‑line PBC market. Subject to successful development and regulatory approval of elafibranor in this indication, GENFIT would be eligible to receive additional milestone payments as well as incremental double‑digit royalties.

Next steps: Phase 3 readout, based on clinical outcomes rather than a surrogate endpoint, is expected around 2031.

Preclinical programs

A pipeline update on ongoing research programs is planned for the third quarter of 2026, covering assets across the ACLF continuum (SRT‑015, CLM‑022, VS‑02‑HE and EViv) as well as Urea Cycle Disorders (UCD) with VS‑01‑HAC.

(Press release, Genfit, MAY 21, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2026-financial-information-and [SID1234665927])