GENFIT Highlights ACLF Development Strategy at “ACLF Day” during AASLD The Liver Meeting 2023

• GENFIT highlighted new focus and development strategy in Acute On-Chronic Liver Failure (ACLF)
• ACLF is a very serious condition affecting ~294,000^{1 2} patients with chronic liver diseases in the USA and Europe every year and is associated with multi-organ failure and high short-term mortality
• It is an underserved medical condition with currently no approved treatment and few programs under development globally
• GENFIT has developed a unique pipeline of 5 different drug candidates targeting key pathophysiological pathways of ACLF
• Phase 2 interim data readout from lead program VS-01 in ACLF targeted for 2Q24
  
  

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 16, 2023 – 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 the highlights from its “ACLF Day” held on November 11, 2023 during AASLD The Liver Meeting in Boston, MA (USA).

GENFIT is now mainly focused on the development of therapies for ACLF which is an area of very high unmet medical need. ACLF is a potentially deadly, but reversible, condition in patients with chronic liver diseases, which is associated with multi-organ failure and high short-term mortality. There is currently no approved treatment for ACLF. The presentation from the event is available on the company website in the investors section.

The development of the company’s new, expanded and diversified pipeline targeting rare and life-threatening liver diseases with high unmet medical needs will be supported by potential milestone payments and royalties deriving from the licensing of elafibranor³ to its partner, Ipsen. At AASLD, Ipsen presented additional data from the ELATIVE Phase 3 study in primary biliary cholangitis (PBC) and announced its publication in the prestigious New England Journal of Medicine (November 2023)⁴. Data from ELATIVE are being used to support Ipsen's submissions for elafibranor as a treatment for PBC with regulatory authorities in the US and EU⁵.

Pascal Prigent, CEO of GENFIT, commented: “During AASLD we were excited to further discuss our development strategy around our new pipeline focused on ACLF, where we believe multiple programs have the potential to transform the treatment paradigm for these patients. It was also great to see more data presented by our partner Ipsen on PBC, which confirm that elafibranor has a competitive profile and a great potential to help patients with this disease. This AASLD meeting reinforced our conviction that Ipsen, as it works through the approval process with regulatory authorities in the US and EU, is committed to getting elafibranor to patients as quickly and efficiently as possible. For GENFIT this could mean significant revenues that will fund the development of a truly unique portfolio aiming at providing solutions for healthcare professionals treating patients suffering from a very challenging condition for which there is currently no approved options. We look forward to presenting preliminary data from our lead ACLF program, VS-01, as early as next year.”