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GENFIT Reports First-Half 2026 Financial Results and Provides Corporate Update
Lille (France), Cambridge (Massachusetts, United States); September 28, 2026 – GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its first half 2026 financial results and provided a corporate update. Pascal Prigent, CEO of GENFIT, commented: “We are pleased with the progress across our businesses and believe we now have a strong platform to build upon. Iqirvo® continues to perform above expectations, with royalty revenue more than tripling in the first half of 2026 compared with the same period last year. This momentum could be further supported by the very encouraging ELSPIRE Phase 3 results and is reflected in Ipsen’s recent increase in its peak-sales guidance to €1 billion. At the same time, our MASH diagnostics business is emerging as a potentially significant contributor to future revenues, as the key challenge in this large market is shifting from treatment availability to patient identification and monitoring. Finally, we are starting three distinct Phase 2 studies, with readouts expected next year, each addressing a challenging condition where we believe our programs have the potential to make a meaningful difference.” I. Financial update Cash and cash equivalents As of June 30, 2026, the Company’s cash and cash equivalents amounted to €113.8 million compared with €101.1 million as of December 31, 2025. In 2026, cash consumption was primarily driven by research and development activities across our Acute-on-Chronic Liver Failure (ACLF) franchise programs, notably NTZ/G1090N, SRT-015, CLM-022 and VS-02 HE, as well as our GNS561 program in cholangiocarcinoma (CCA). This cash consumption was offset by two significant cash inflows during the first half of 2026: (i) the second €30.0 million tranche received under the royalty financing agreement and (ii) the receipt of the first commercial milestone payment of €17.0 million from Ipsen (USD$20.0 million), which had already accrued for in 2025 and received in 2026.. 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. Financial highlights The table below presents the condensed Consolidated Statement of Operations under International Financial Reporting Standards (IFRS) for the first half of 2026, with comparative figures for the first half of 2025.
The Group’s condensed statement of financial position, condensed statement of net income and condensed statement of cash flows, prepared in accordance with IFRS accounting standards, are presented in the Appendix of this document. Detailed information on the condensed consolidated financial statements, together with the statutory auditors’ review report, is provided in the 2026 Half-Year Business and Financial Report, available in the “Investors” section of GENFIT’s website. We encourage investors to take into consideration all the information presented in our 2025 Universal Registration Document filed under D.26-0221 with the French Autorité des Marchés Financiers (AMF) on April 3, 2026 and the 2026 Half-Year Business and Financial Report before deciding to invest in Company shares; these documents are available on GENFIT’s website: www.genfit.com and on the website of the AMF (www.amf-france.org). This includes, in particular, the risk factors described in section 2 of the 2025 Universal Registration Document, as well as the update provided in section 2.5 of the 2026 Half-Year Business and Financial Report, of which the realization may have (or has had in some cases) material adverse effect on the Group and its activity, financial situation, results, development or perspectives, and which are of importance in the investment decision-making process. Financial highlight comments Revenue
Royalty revenue Milestone revenue When comparing total revenues year on year, the timing of milestone payments should be kept in mind: revenues in the first half of 2025 included a milestone payment, whereas no milestone revenue was recognized in the first half of 2026. Additional milestone payments may, however, be recognized in the future. Other income
The increase in the CIR research tax credit compared to the prior period was primarily driven by an increase in eligible research and development expenses. Operating expenses Operating expenses amounted to €33.8 million in 2026, compared with €35.6 million in 2025, and comprised research and development expenses, general and administrative expenses, marketing and pre-commercialization expenses, and other operating income and expenses. Research and development expenses decreased in 2026 compared with the prior period, primarily as a result of the discontinuation of the VS-01-ACLF program in 2025. This decrease was partially offset by the advancement of development activities across the Group’s other priority programs, notably nitazoxanide (NTZ), VS-02-HE, GNS561 and VS-01-UCD. General and administrative expenses decreased in 2026 compared with the prior period, primarily due to the non-recurrence of costs related to the liquidation of Versantis recognized in 2025, as well as cost savings resulting from the Company’s delisting from the Nasdaq. Financial results The Group recorded a financial loss of €17.4 million in the first half of 2026, compared with a financial loss of €10.2 million in the first half of 2025. Financial expenses increased in 2026 compared with the prior period, primarily due to changes in the fair value of the royalty financing liability recognized in profit or loss. Net loss The first half of 2026 resulted in a net loss of €26.1 million, compared with a net loss of €10.0 million in the first half of 2025. II. Business update Two emerging revenue streams
PBC – On July 30, 2026 Ipsen reported its Iqirvo (elafibranor) sales results for the first half of 2026. Ipsen upgraded its peak sales estimates from €500 million to €1 billion in Primary Biliary Cholangitis (PBC). This revision followed Ipsen's announcement on July 13, 2026, that the primary endpoint of alkaline phosphatase (ALP) normalization had been achieved in 85% of patients treated with Iqirvo (elafibranor), compared with 23% of patients receiving placebo, in the Phase 3 ELSPIRE study. This revision is also 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 six months of 2026 amounted to €173 million2. 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.
Program status – In August 2026, Medicare reimbursement of Labcorp's NASHnext® test (based on GENFIT's NIS™ technology) became effective under the Clinical Laboratory Fee Schedule for patients meeting coverage criteria. GENFIT believes broader reimbursement by private payers, if obtained, could support accelerated adoption of its technology over time. Further market expansion could also be supported by a potential future in vitro (IVD) launch, which may facilitate deployment across a wider range of healthcare settings. R&D pipeline
Two assets in Acute on-Chronic Liver Failure (ACLF)
Nangibotide is expected to enter a Phase 2 study in ACLF in the fourth quarter of 2026, with data readout targeted in 2027. One asset in oncology
ACLF – GENFIT’s strategy for the treatment of ACLF is concentrated around its two most advanced assets, nangibotide and NTZ, both entering Phase 2 clinical investigations in 2026, as well as the potential of extracellular vesicle-based approaches. This focus is underpinned by robust body of evidence generated through internal preclinical research, external datasets, translational analyses, and ongoing interactions with leading international hepatology and critical care experts. GENFIT is thus directing its capital and development resources towards the programs with the strongest translational rationale and clinical potential, and has discontinued the development of SRT-015 and CLM-022 programs. The evaluation of the VS-02-HE program remains ongoing, alongside continued exploration of additional mechanisms of action relevant to ACLF. Further updates will be provided as these programs mature and progress toward clinical development. Oncology – Following the encouraging preliminary results observed with GNS561 in combination with a MEK inhibitor in cholangiocarcinoma (CCA), further supporting the therapeutic potential of autophagy inhibition, GENFIT has initiated research activities to explore this approach in additional oncology indications and in combination with other therapeutic agents. Further details will be provided as and when these programs advance into clinical development. Corporate governance updates In February 2026, Mr. John BROZEK replaced Ms. Florence SÉJOURNÉ as permanent representative of Biotech Avenir SAS on the Company's Board of Directors. Extra-financial performance In May 2026 GENFIT published its annual Extra-Financial Performance Report (fiscal year 2025), highlighting its latest initiatives and providing insights on the evolution of key performance indicators. In terms of recognition, GENFIT maintained its “Prime status” with ISS ESG and gold medal awarded by Ethifinance in recognition of its ESG performance. GENFIT is also a Certified B Corporation since 2025.
The Condensed Consolidated Statements of Financial Position, Statements of Operations and Statements of Cash Flow of the Group were prepared in accordance with the IFRS. The limited review procedures on the condensed consolidated financial statements have been performed. The half-year consolidated financial statements for the period ended June 30, 2026 were approved by the Board of Directors on September 28, 2026. The condensed consolidated financial statements as well as the notes to the consolidated financial statements for the period ended June 30, 2026 and the statutory auditor’s report on the consolidated financial statements are included in the Half Year Business and Financial Report at June 30, 2026 available on the “Investors” page of the GENFIT website. All financial information (unless indicated otherwise) is presented in thousands of euros (€). Condensed Consolidated Statement of Financial Position Assets
Shareholders’ equity and liabilities
Condensed Consolidated Statement of Operations
Condensed Statement of Cash Flows
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 second-line treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.4 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) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT) and joined the CAC Mid 60 and SBF 120 indices on September 18, 2026. 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 relating to the sales trajectory and future commercial performance of Iqirvo® in PBC, elafibranor’s ability to be successfully developed and subsequently approved in PSC, and the size of the market opportunity that PSC may represent; the possibility of receiving future milestone payments and royalties under its license agreement with Ipsen; relating to the future development of its NIS™ technologies in MASH diagnosis and the size of the market opportunity that MASH may represent, including the development and regulatory approval of new MASH therapies and their commercial adoption and rollout; the adoption of NASHnext® as a diagnostic test to identify patients with at-risk MASH and the size of this patient population; reimbursement of the test by private payors; the Company's ability to establish partnerships with major pharmaceutical companies commercializing such therapies; its ability to develop an IVD (In Vitro Diagnostic) version of a diagnostic test based on these technologies; and the possibility of receiving future revenues under its license agreement with Labcorp; relating to the future development of the GNS561/trametinib combination and the anticipated timelines for obtaining additional Phase 1b results, initiating Phase 2 of the ongoing Phase 1b/2 clinical trial in CCA, and obtaining the results thereof, as well as the potential of GNS561 in combination with other treatments and/or in other cancer indications; relating to the future development of NTZ/G1090N in ACLF, including the significance and implications of NTZ's FDA Orphan Drug Designation (ODD), the initiation of a Phase 2 clinical trial under the NTZ/G1090N program, and the anticipated timelines for obtaining its results; relating to the future development of nangibotide, including the potential relevance on future clinical investigations of efficacy signals and safety data observed in prior clinical studies conducted in other indications, as well as the Company's ability to initiate a Phase 2 program with this drug candidate in this indication and the anticipated timelines for such initiation and the availability of results; relating to the objectives of its portfolio management strategy; and, more generally, forward-looking statements regarding its financial position, the expected progress of its research and development programs, and their potential therapeutic benefits in the indications for which they are intended. 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 2025 Universal Registration Document filed on April 3, 2026 (no. 26-0221) 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 reports filed with the AMF 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 Kevin Gardner – Life Science Advisors | [email protected] GENFIT | Media Stephanie BOYER | Tel : + 33 3 20 16 40 00 | [email protected]
1 Iqirvo® is a registered trademark of GENFIT SA 2 https://www.ipsen.com/wp-content/uploads/2026/07/Ipsen-PR_HY-2026_30072026.pdf 3 Regulatory authorization through the applicable local approval process is required for IVD products and has not yet been obtained. 4 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® Attachment 
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