GENFIT Reports Full-Year 2024 Financial Results and Provides Corporate Update

   -- Cash and cash equivalents totaled EUR81.8 million as of December 31, 
      2024. In addition, completion in early 2025 of: (i) a non-dilutive 
      royalty financing agreement for up to EUR185 million including a first 
      installment of EUR130 million and (ii) the debt repurchase offer 
 
   -- Net profit of EUR1.5 million thanks to revenues amounting to EUR67.0 
      million for the period ended December 31, 2024, including a EUR48.7 
      million milestone payment and royalties 
 
   -- In 2024, Iqirvo$(R)$ received marketing approval in PBC in both the United 
      States and Europe, and was subsequently commercially launched in the U.S. 
      and in some European countries by Ipsen, who reported an acceleration in 
      1Q25 sales growth in line with expectations 
 
   -- In ACLF, several new datasets highlighting the potential of our main 
      assets and providing a strong rationale for further development have been 
      produced and presented at various scientific meetings. Meanwhile, a major 
      initiative based on analysis of Real-World data helped improve 
      understanding of ACLF and its continuum. Key clinical data readouts 
      expected by year-end. 

Lille, France; Cambridge, MA; Zurich, Switzerland; April 24, 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, today announced annual financial results for the year ended December 31, 2024. A summary of the consolidated financial statements is included below.

Pascal Prigent, CEO of GENFIT commented: "In 2024 the commercial launch of Iqirvo(R) by Ipsen marked a major milestone in GENFIT's history as we evolved from a pure R&D company into a company with commercial revenues. This enabled us to considerably strengthen our financial visibility and eliminate our convertible debt overhang, as we pivot decisively towards the advancement of our innovative pipeline in ACLF. With five dedicated programs, GENFIT has positioned itself as a key player to address this deadly condition, for which there is no approved treatment. In 2024, major progress was achieved in our understanding of the ACLF continuum and patients with ACLF. Key insights generated will provide a solid foundation for the continued development of our programs in 2025."

I. 2024 Highlights -- including post-closing events

Iqirvo(R) in Primary Biliary Cholangitis $(PBC)$: regulatory approvals and commercial launch

In 2024, GENFIT and its partner Ipsen reported significant commercial and regulatory advances with Iqirvo(R)(1) (elafibranor) in the United States, Europe and the UK.

Ipsen's Iqirvo(R)(2) received accelerated approval from the U.S. Food and Drug Administration (FDA) on June 10, 2024 as a first-in-class treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults who are unable to tolerate UDCA. GENFIT received a milestone payment of EUR48.7 million upon the first sale of Iqirvo(R) in the US.

Ipsen also received conditional approval from the European Commission on September 20, 2024 for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA, or as monotherapy in adults who are unable to tolerate UDCA, and from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on October 9, 2024, followed by reimbursement approval from the National Institute for Health and Care Excellence $(NICE)$ on October 22, 2024.

On April 16, 2025, Ipsen reported "accelerated sales growth in the U.S. based on increasing patient uptake from new patients, switch and market expansion, successful launches in Germany and the UK with additional launches expected in 2025".(3)

Meaningful progress across ACLF programs

In 2024, we launched and executed a major Real-World data program designed to improve understanding of the ACLF syndrome and support more targeted, data-driven decision-making:

   -- Using a U.S. database including comprehensive information on patients, 
      encompassing clinical characteristics, diagnosis, prescriptions, 
      comorbidities, outcomes, and laboratory values. Data from 270 000 
      patients provided a longitudinal perspective on patient profiles and 
      disease progression. 
 
   -- Development of a machine learning model to segment subgroups of patients 
      with ACLF and those with Acute Decompensation (AD) of the liver, 
      facilitating a deeper understanding of risk stratification across 
      different patient profiles. 
 
   -- The first key outcome of this project was an in-depth analysis of the 
      disease continuum between patients with AD and ACLF, as well as a 
      detailed characterization of subpopulations at varying levels of 
      mortality risk. These insights served as a scientific foundation for 
      updating GENFIT's 2025 strategic action plan, supporting the decision to 
      expand our target population in upcoming trials to include a subset of 
      patients with high-risk AD who are more likely to progress to ACLF. 

VS-01-ACLF -- The UNVEIL-IT(R)(1) Phase 2 trial for VS-01 continued to progress, with expanded geographic reach including new sites in the U.S. Following early recruitment challenges, protocol adjustments were implemented to better reflect patient care logistics and comorbidities. New data were also generated to give more flexibility to healthcare providers in the timing of administration of the drug. New datasets were showcased during international scientific congresses. New "blood and peritoneal metabolomics data suggesting that VS-01 actively captures metabolites associated with ACLF" were presented at EASL congress, and "VS-01 effects on ACLF-related toxins such as lipopolysaccharide and hydrophobic bile acids in vitro" were shared during AASLD The Liver Meeting(R).

NTZ (nitazoxanide) -- Data indicating that "NTZ directly protects from stress-induced cell death to alleviate liver damage in preclinical models of ACLF" were reported at EASL congress, and "NTZ efficacy in PAMPs-induced disease models" was showcased during AASLD The Liver Meeting(R). These data reinforce the therapeutic potential of investigational drug NTZ to act on major pathological pathways of ACLF. In 2024, a program aimed to develop G1090N -- a new formulation of NTZ -- also initiated to optimize dose-response and permit sufficient dosing flexibility in patients with ACLF, who are known to have varying degrees of renal or hepatic impairment or failure.

SRT-015 -- As highlighted during AASLD The Liver Meeting(R), preclinical analyses demonstrated that "intravenous administration of SRT-015 alleviates liver injury and systemic inflammation in disease models of liver failure", supporting further development. Additional positive data were also obtained in a gut leakage-induced sepsis model, where SRT-015 was shown to protect animals from mortality.

CLM-022 -- Significant progress was made, with new data positioning "CLM-022, a potent inhibitor of NLRP3 inflammasome-mediated pyroptosis, as a potential treatment for acute and chronic inflammatory liver diseases". First in-vivo data have shown that one oral administration of CLM-022 decreases inflammation and protects against liver injury in a model of acute liver injury in mice.

2024 also marked the start of a research collaboration between GENFIT and the European Foundation for the Study of Chronic Liver Failure (EF CLIF), reinforcing our leadership in advancing the understanding of ACLF. Other collaboration with learned societies included engagement with US KOLs from NACSELD(4) .

Other R&D developments

Cholangiocarcinoma $(CCA)$ -- Preliminary safety data analyzed end of 2024 from the patients treated in the first cohort of Phase 1b with the combination of GNS561 and trametinib were supportive of the continuation of the study. In early 2025, GENFIT completed the acquisition of the full intellectual property rights for GNS561 from Genoscience Pharma, replacing the more limited license agreement rights initially obtained at the end of 2021.

Diagnostics -- NIS2+(R) was included in the European clinical practice guidelines for the management of metabolic dysfunction-associated steatotic liver disease (MASLD) as a key tool for detecting at-risk MASH. These new recommendations were presented at the EASL 2024 congress, and have been published in the Journal of Hepatology(5) .

Transformative royalty financing and debt overhang reduction

In 2024, GENFIT initiated a dual-transaction initiative to reinforce its financial outlook, that was successfully completed in March 2025:

   -- Completion of a non-dilutive royalty financing agreement for up to EUR185 
      million. This agreement triggered an initial payment of EUR130 million, 
      with the possibility of receiving a further EUR55 million in two 
      installments depending on the achievement of short-term net sales targets 
      for Iqirvo(R) (elafibranor). 
 
   -- Repurchase of 99% of the outstanding OCEANE convertible debt, effectively 
      extinguishing the convertible debt burden without any dilution to 
      shareholders. 

(MORE TO FOLLOW) Dow Jones Newswires

April 24, 2025 16:10 ET (20:10 GMT)