On September 22, 2025 GENFIT (Nasdaq and 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 2025 financial results and provided a corporate update (Press release, Genfit, SEP 22, 2025, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-half-2025-financial-results-and-provides [SID1234656146]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Pascal Prigent, CEO of GENFIT, commented: "Although our recent discontinuation of VS-01 in ACLF was disappointing news, it was the right decision for patients. Since we embarked in ACLF, we have engaged with many healthcare professionals, regulators, and patient associations, and we’re more convinced than ever by the importance of developing novel therapeutic options in this underserved indication. Of course, risk is inherent to drug development, but we mitigate it with six programs underway, and two data sets expected by the end of the year. Following the discontinuation of VS-01 in ACLF, we anticipate a substantial reduction in our operating expenses. This will extend projected cash runway beyond 2028 and offer optionality as we continue to explore new mechanistic approaches to tackle the multiple dimensions of ACLF care."
I. 1H25 Business highlights and main events after the reporting period2
Acute on-Chronic Liver Failure (ACLF): Discontinuation of VS-01 program, refocused on UCD
On September 19, 2025, GENFIT announced its decision to discontinue its VS-01 program in ACLF, and reprioritize its development on Urea Cycle Disorder (UCD):
GENFIT’s decision followed the occurrence of a peritonitis case reported as a Serious Adverse Event (SAE) in the UNVEIL-IT clinical trial evaluating VS-01 in patients with ACLF grade 1, 2 or 3a and ascites and subsequent review and feedback from the independent Data Monitoring Committee (iDMC). The committee concluded that the trial could continue but required additional data and monitoring. Despite the possibility to move ahead with the study, GENFIT decided – after considering the target population’s clinical profile as well as the implications of this type of safety signal for the benefit/risk ratio of VS-01 in this indication – to discontinue both UNVEIL-IT and the proof-of-concept study evaluating VS-01 in patients with Hepatic Encephalopathy (HE) grades 2 to 4 in the presence of Acute Decompensation (AD) or ACLF grade 1 and ascites.
GENFIT will continue the preclinical evaluation of VS-01 in UCD, a genetically driven disorder characterized by acute hyperammonemic crisis (HAC). The condition, patients and drug administration set-up will be very different from what they were in ACLF. There is a significant unmet medical need in this indication, and based on ammonia clearance data, we believe VS-01 has the potential to be a useful therapeutic option for children affected by this disease.
GENFIT remains fully committed to ACLF and associated conditions such as Acute Decompensation (AD) or Hepatic Encephalopathy (HE). ACLF is characterized by a critical unmet medical need, with no approved treatment options for patients facing poor prognosis and life-threatening risks. Since we embarked in this therapeutic area, we have engaged in multiple KOL interactions and observed growing interest in this indication, together with clear support for our clinical strategy. This feedback reinforces our confidence in our plan and validates our positioning. In this context, we ambition to accelerate the development of the four other assets currently under development in ACLF, which are all based on different mechanisms of action and use different routes of administration. We hope to deliver positive results, as we move forward, starting with safety data and early markers of efficacy on healthy volunteers with G1090N, expected at the end of this year. Other programs in the ACLF pipeline are SRT-015, CLM-022 and VS-02-HE.
Earlier in May 2025, GENFIT participated at the European Association for the Study of the Liver (EASL) International Congress 2025 with several posters presenting its latest progress in ACLF. The congress highlighted the growing importance of ACLF within the hepatology community.
PBC: new milestone payment, encouraging sales performance of Iqirvo (elafibranor) by our partner Ipsen and withdrawal of key competitor in the US market
In May 2025, Ipsen’s Iqirvo (elafibranor) was granted pricing and reimbursement in Italy for Primary Biliary Cholangitis (PBC). This major step unlocked a new €26.5 million milestone payment under our Licensing and Collaboration Agreement with Ipsen, due upon pricing and reimbursement of Iqirvo (elafibranor) in three major European markets.3
In July 2025, Ipsen reported "accelerated sales growth of €59m in the first half of 2025 in the U.S. and in Europe (mainly Germany & the U.K.) driven by increasing uptake from new patients, switch and market expansion sales for Iqirvo 4".
In September 2025, Intercept Pharmaceuticals, a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., announced its decision to withdraw OCALIVA (obeticholic acid) from the US market for the treatment of PBC.5 This decision followed a request from the US Food and Drug Administration (FDA). We expect this to create a market dynamic that should support the sales trajectory of Iqirvo by our partner Ipsen.
PSC: positive late-breaking Phase 2 data for elafibranor presented by Ipsen at EASL Congress 2025
In May 2025, Ipsen presented data from its late-breaking abstract on elafibranor, highlighting favorable safety profile and significant efficacy in Primary Sclerosing Cholangitis (PSC), at the European Association for the Study of the Liver (EASL). Should elafibranor be approved in a second indication after PBC, GENFIT would also be eligible for milestone payments and royalties under the Licensing and Collaboration Agreement with Ipsen.
CCA: acquisition of full intellectual property rights for GNS561 from Genoscience Pharma
In early 2025, GENFIT completed the acquisition of the full intellectual property rights for GNS561 from Genoscience Pharma, expanding upon the limited rights initially obtained through a license at the end of 2021. GENFIT acquired all patents and patent applications, know-how, and data held by Genoscience Pharma necessary for the development, manufacturing, and marketing of GNS561 worldwide.*
Financing: Closing of royalty financing agreement with HCRx significantly extends cash runway
The Royalty Financing6 agreement signed in March 2025 has significantly extended GENFIT’s cash runway, beyond the end of 2028, enabling the Company to further develop its pipeline focused on Acute-on-Chronic Liver Failure (ACLF) and support general corporate purposes. This estimation 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 license agreement with Ipsen and Ipsen meeting its sales-based thresholds, ii) drawing down all additional installments under the Royalty Financing, and iii) the reimbursement at maturity in October 2025 of any OCEANEs not converted or repurchased and cancelled 7 and iv) the discontinuation of the VS-01 program in ACLF as outlined above.
Corporate governance updates
Following the retirement of Chief Medical Officer Carol Addy on June 30, 2025, a new CMO has been appointed and will officially assume the role at the end of the year.
Chief Scientific Officer Dean Hum will retire, effective as of September 30, 2025. He will be replaced by Sakina Sayah-Jeanne, currently EVP Research & Translational Science and member of the Executive Committee since she joined GENFIT in 2023. Pascal Prigent, CEO of GENFIT, commented: "I’m delighted to officially welcome Sakina as our new Chief Scientific Officer. Having already demonstrated outstanding leadership since she joined GENFIT, she is uniquely positioned to guide our scientific strategy and execute on the plan. And on behalf of everyone at GENFIT, I want to thank Dean for his considerable contribution since GENFIT’s inception in 1999. Dean has been instrumental over the years in moving our programs forward, including elafibranor in PBC. As Dean transitions into retirement, we are grateful that he will remain active as advisor, continuing to share his expertise."
At the June 2025 Annual Meeting, Mr. Tristan Imbert was appointed by our shareholders as director for a three-year term and joined the Audit Committee and ESG Committee.
Extra-financial performance
In May 2025, GENFIT published its annual Extra-Financial Performance Report (fiscal year 2024), highlighting its latest initiatives and providing insights on the evolution of key performance indicators. In terms of recognition, ISS ESG increased our rating from C+ to B- maintaining our "Prime status".
II. 2H25 and beyond: key milestones and outlook
ACLF pipeline
G1090N – Safety data and early markers of efficacy are expected by the end of 2025, and will serve to optimize the design of the proof-of-concept study targeted to start in the first half of 2026, with the objective to generate efficacy data by the end of 2026.
SRT-015 – Current work on an improved formulation aims at increasing exposure. Pending positive development, the launch of a first-in-human trial could be initiated as early as the second half of 2026.
CLM-022 – Current experiments aim at confirming therapeutic efficacy using different disease models relevant for AD and ACLF as well as starting formulation development and first toxicological studies in 2025. Pending further positive developments, a first-in-human trial could be initiated in the first half of 2027.
VS-02-HE – We intend to develop VS-02-HE as a unique oral formulation designed to act in the gut where ammonia is primarily produced, minimizing systemic absorption of ammonia while reducing glutamine levels in the brain. Completion of Investigational New Drug-enabling nonclinical studies and formulation development are expected by the end of 2025. Pending further confirmation, a first-in-human trial could be initiated in the second half of 2027.
Other life-threatening diseases
GNS561 in CCA – Data readout from the ongoing Phase 1b clinical trial are expected by the end of 2025.
VS-01-HAC (pediatric indication) – Following feedback from the FDA (U.S.) and PDCO8 (Europe), the pivotal juvenile toxicology study in Göttingen Minipigs started and data are expected before the end of 2025. Following discontinuation of VS-01 in ACLF, additional preclinical work will be conducted before moving into the clinic. Depending on the outcome of preclinical work, a first-in-human trial could be initiated as early as the second half of 2026.
III. 1H25 Financial highlights
Cash and cash equivalents
As of June 30, 2025, GENFIT had €107.5 million in cash and cash equivalents compared with €81.8 million as of December 31, 2024. Cash and cash equivalents as of June 30, 2025 exclude the milestone payment of €26.5 million invoiced in May 2025 (received in July 2025), following the approval of pricing and reimbursement for Iqirvo (elafibranor) by three major European countries.
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 pipeline focused on Acute-on-Chronic Liver Failure (ACLF) and support general corporate purposes. This estimation 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 license agreement with Ipsen and Ipsen meeting its sales-based thresholds, ii) drawing down all additional installments under the Royalty Financing, and iii) the reimbursement at maturity in October 2025 of any OCEANEs not converted or repurchased and cancelled9 and iv) the discontinuation of the VS-01 program in ACLF as outlined above.
In the first half of 2025, cash utilization mainly stems from our research and development efforts, notably UNVEIL-IT, our Phase 2 clinical trial of VS-01 in ACLF (and related proof-of-concept study); GNS561, as part of its Cholangiocarcinoma program; NTZ, as part of its ACLF program; SRT-015, as part of its ACLF program; and CLM-22, as part of its ACLF program.
Revenues and other income
Revenues and other income amounted to €35.7 million in the first half of 2025, compared to €61.2 million in the first half of 2024.
Substantially all revenue is attributable to our Collaboration and License Agreement with Ipsen in 2025, including i) royalty revenue from worldwide sales (excluding Greater China) of Ipsen’s Iqirvo (elafibranor) totaling €6.9 million and ii) milestone revenue from pricing and reimbursement approval of Iqirvo (elafibranor) by three major European countries totaling €26.5 million.
Operating expenses
Operating expenses amounted to €35.6 million in the first half of 2025, compared to €30.0 million in the first half of 2024).
Substantially all of the increase in operating expenses is due to research and development expenses, which amounted to €25.1 million in the first half of 2025 (compared to €19.0 million in the first half of 2024). Specifically, there was increased spending related to contracting costs, which amounted to €13.4 million in the first half of 2025 (compared to €7.8 million in the first half of 2024), primarily reflecting increased activities related to VS-01 in ACLF .
Financial results
For the half-year ended June 30, 2025, financial income amounted to a loss of €10.2 million, compared to a loss of €0.9 million for the same period in 2024. The increase relates to debt issuance costs and financial charges from the Royalty Financing agreement.
Net loss
The first half of 2025 resulted in a net loss of €10.0 million, compared with a net profit of €30.3 million in the first half of 2024.
The table below presents the condensed Consolidated Statement of Operations under the International Financial Reporting Standards (IFRS) for the first half of 2025, with comparative figures for the first half of 2024.