On 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, reported its first half 2026 financial results and provided a corporate update.

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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.

Half-year ended
(in € thousands, except earnings per share data) 2025/06/30 2026/06/30
Revenues and other income
Revenue 33,488 21,073
Other income 2,182 3,960
Revenues and other income 35,670 25,033
Operating expenses and other operating income (expenses)
Research and development expenses (25,117) (24,927)
General and administrative expenses (9,971) (8,328)
Marketing and market access expenses (392) (15)
Other operating expenses (115) (487)
Operating income (loss) 76 (8,724)
Financial income 1,850 1,463
Financial expenses (12,027) (18,854)
Financial profit (loss) (10,178) (17,392)
Net profit (loss) before tax (10,102) (26,116)
Income tax benefit (expense) 146 (5)
Net profit (loss) (9,956) (26,120)
Basic and diluted earnings (loss) per share
Basic earnings (loss) per share (€/share) (0.20) (0.52)
Diluted earnings (loss) per share (€/share) (0.20) (0.52)
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

Revenue Half-year ended
(In € thousands) 30/06/2025 30/06/2026
Royalty revenue 6,871 20,975
Milestone revenue 26,556 0
Other revenue 61 98
TOTAL 33,488 21,073
Royalty revenue
Virtually all royalty revenue is derived from worldwide sales of Ipsen’s Iqirvo1 (elafibranor) under the Ipsen Agreement. These are utilized to repay the Group’s Royalty Financing agreement.

Milestone revenue
On May 20, 2025, GENFIT announced that Ipsen’s Iqirvo (elafibranor) was granted pricing and reimbursement in Italy for PBC, the third major European country to do so in addition to the UK and Germany. This third approval triggered a new milestone payment of €26.5 million under GENFIT’s Licensing and Collaboration Agreement with Ipsen, due upon pricing and reimbursement of Iqirvo (elafibranor) in three major European markets.

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

Other income Half-year ended
(in € thousands) 06/30/2025 06/30/2026
CIR tax credit 2,030 3,091
Other operating income (including exchange gains on trade payables and receivables) 135 854
Government grants and subsidies 17 15
TOTAL 2,182 3,960
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

Elafibranor in cholestatic liver diseases

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.
PSC – Beyond PBC, Ipsen announced the initiation of the Phase 3 ELASCOPE study evaluating elafibranor in Primary Sclerosing Cholangitis (PSC) in early 2026. 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. Data readout from the Phase 3 trial is expected around 2031.

NISTM Technology in MASH

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.
Highlights on U.S. Market Potential – Based on intention-to-diagnose data collected across key specialties, increasing disease prevalence, and a staged commercialization strategy spanning Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs), IQVIA estimates U.S. peak sales of products using GENFIT’s technology could exceed $1.5 billion by 2033, with annual testing volume in the U.S. reaching more than 7 million tests.3
Beyond the United States – In Europe and Asia, GENFIT expects its IVD strategy to play a key role in the future commercialization of its NIS technology. Supported by the anticipated expansion of the MASH therapeutic market and the broader accessibility enabled by IVD products, international markets could represent a meaningful additional revenue opportunity over time.

R&D pipeline

Clinical stage: Three programs entering Phase 2 clinical development in the second half of 2026

Two assets in Acute on-Chronic Liver Failure (ACLF)
Nangibotide – In summer 2026, GENFIT acquired nangibotide, a differentiated late-stage asset, reinforcing the Company’s portfolio of innovative therapies addressing high unmet medical needs. The investigation in Phase 2 is supported by a robust scientific and clinical foundation around the TREM-1 pathway and the asset’s profile:

Strong knowledge of nangibotide’s biological pathway
Multiple efficacy signals already observed with nangibotide in post-hoc analyses of three Phase 2 clinical trials in septic shock and COVID-19 subjects, including a statistically significant reduction in mortality in severe COVID-19 and significant improvements in SOFA score from baseline in septic shock
Overall favorable safety and tolerability profile demonstrated across four clinical trials, with more than 400 subjects exposed to nangibotide, and no meaningful differences versus placebo in safety outcomes

Nangibotide is expected to enter a Phase 2 study in ACLF in the fourth quarter of 2026, with data readout targeted in 2027.
Nitazoxanide (NTZ) – Positive Phase 1 data reported in early 2026 confirmed the favorable safety profile of 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. A proof‑of‑concept study was initiated in the third quarter of 2026, with data expected in 2027.

One asset in oncology
GNS561 – Encouraging preliminary data from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA were disclosed in December 2025 and June 2026. This Phase 1b dose escalation is progressing as planned, with additional data anticipated in the second half of 2026, following study expansion into additional cohorts supported by preliminary signals. The Phase 2 initiation is on track for launch in the second semester of 2026. Phase 2 data readout is targeted in 2027.

Research stage: multiple targets in ACLF and 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.

Half-year Consolidated Financial Results at June 30, 2026

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

As of
(in € thousands) 2025/12/31 2026/06/30
Current assets
Cash and cash equivalents 101,093 113,822
Current trade and other receivables 40,328 24,776
Other current assets 2,857 2,813
Inventories 4 4
Total – Current assets 144,282 141,416
Non-current assets
Intangible assets 4,155 2,102
Property, plant and equipment 7,100 6,674
Other non-current financial assets 3,503 3,375
Deferred tax assets 0 0
Total – Non-current assets 14,759 12,151
Total – Assets 159,041 153,567
Shareholders’ equity and liabilities

As of
(in € thousands) 2025/12/31 2026/06/30
Current liabilities
Current convertible loans 0 0
Other current loans and borrowings 2,025 2,020
Current trade and other payables 26,392 19,192
Current provisions 2,958 2,052
Other current tax liabilities 0 0
Total – Current liabilities 72,312 89,251
Non-current liabilities
Other non-current loans and borrowings 3,546 2,535
Non-current employee benefits 1,475 1,580
Deferred tax liabilities 0 0
Total – Non-current liabilities 109,265 112,852
Shareholders’ equity
Share capital 12,509 12,524
Share premium 440,303 440,930
Retained earnings (accumulated deficit) (389,813) (475,908)
Currency translation adjustment 433 38
Net profit (loss) (85,968) (26,120)
Total – Shareholders’ equity (22,536) (48,536)
Total – Shareholders’ equity & liabilities 159,041 153,567

Condensed Consolidated Statement of Operations

Half-year ended
(in € thousands, except earnings per share data) 2025/06/30 2026/06/30
Revenues and other income
Revenue 33,488 21,073
Other income 2,182 3,960
Revenues and other income 35,670 25,033
Operating expenses and other operating income (expenses)
Research and development expenses (25,117) (24,927)
General and administrative expenses (9,971) (8,328)
Marketing and market access expenses (392) (15)
Other operating expenses (115) (487)
Operating income (loss) 76 (8,724)
Financial income 1,850 1,463
Financial expenses (12,027) (18,854)
Financial profit (loss) (10,178) (17,392)
Net profit (loss) before tax (10,102) (26,116)
Income tax benefit (expense) 146 (5)
Net profit (loss) (9,956) (26,120)
Basic and diluted earnings (loss) per share
Basic earnings (loss) per share (€/share) (0.20) (0.52)
Diluted earnings (loss) per share (€/share) (0.20) (0.52)
Condensed Statement of Cash Flows

Half-year ended Half-year ended
(in € thousands) 2025/06/30 2026/06/30
Cash flows from operating activities
+ Net profit (loss) (9,956) (26,118)
Reconciliation of net loss to net cash used in operating activities
Adjustments for:
+ Depreciation and amortization on tangible and intangible assets 897 943
+ Impairment and provisions 193 2,238
+ Expenses related to share-based compensation 242 485
– Loss (gain) on disposal of property, plant and equipment (12) 0
+ Net finance expenses (revenue) 6,324 17,940
+ Income tax expense (benefit) (146) 5
+ Other non-cash items 590 (11)
Operating cash flows before change in working capital (1,868) (4,518)
Decrease (increase) in trade receivables and other assets (37,840) 14,190
(Decrease) increase in trade payables and other liabilities 9,606 (6,714)
Change in working capital (28,234) 7,476
Income tax paid 0 0
Net cash flows provided by (used in) in operating activities (30,102) 2,958
Cash flows from investment activities
– Acquisition of other intangible assets (2,034) (6)
– Acquisition of property, plant and equipment (1,054) (537)
+ Proceeds from disposal of / reimbursement of property, plant and equipment 39 0
– Acquisition of financial instruments (170) (37)
+ Proceeds from sale of financial instruments 0 22
Net cash flows provided by (used in ) investment activities (3,219) (557)
Cash flows from financing activities
+ Proceeds from issue of share capital (net) 17 154
+ Proceeds from new loans and borrowings 130,020 30,000
– Repayments of loans and borrowings (62,105) (431)
– Repayments of royalty financing liability (4,492) (18,723)
– Payments of debt issuance costs (3,363) (375)
– Payments on lease debts (555) (586)
– Financial interests paid (including finance lease) (530) (34)
+ Financial interests received 295 429
Net cash flows provided by (used in ) financing activities 59,287 10,435
Increase (decrease) in cash and cash equivalents 25,966 12,835
Cash and cash equivalents at the beginning of the period 81,788 101,093
Effects of exchange rate changes on cash (243) (106)
Cash and cash equivalents at the end of the period 107,511 113,822

(Press release, Genfit, SEP 28, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-half-2026-financial-results-and-provides [SID1234671120])