PV FIT LIMITED

GENFIT's November 2024 corporate investor presentation covers forward-looking statements, ACLF disease state, market opportunity, and pipeline updates, including elafibranor's potential approvals and milestones.

GENFIT presents pre-clinical data on ACLF treatments at The Liver Meeting 2024, including VS-01, SRT-015, CLM-022, and NTZ, and leads key ACLF events. The company anticipates data from four clinical trials by end of 2025, focusing on VS-01, NTZ, and SRT-015. GENFIT also presents NIS2+® data for MASH monitoring.

The European Commission approves Ipsen's IQIRVO (elafibranor) for primary biliary cholangitis, the first new therapy in the EU in a decade. Other companies, including CymaBay, Zydus, and GlaxoSmithKline, are preparing to enter the market. The approval is based on the Phase III ELATIVE trial, showing a 47% clinical benefit of IQIRVO combined with UDCA. Additionally, Gilead Sciences' LIVDELZI (seladelpar) received FDA accelerated approval for PBC.

The European Commission has conditionally approved Ipsen’s Iqirvo (elafibranor) for primary biliary cholangitis (PBC), the first drug for the liver disease in nearly a decade. The approval is for Iqirvo in combination with ursodeoxycholic acid in adults who do not respond adequately to ursodeoxycholic acid alone, or as a monotherapy for those unable to take ursodeoxycholic acid. The decision follows an accelerated approval by the FDA in June, based on Phase III ELATIVE trial data showing greater treatment benefits with Iqirvo plus ursodeoxycholic acid compared to a placebo.

GENFIT announces European Commission's conditional approval of Iqirvo® (elafibranor) 80mg tablets for Primary Biliary Cholangitis (PBC) treatment, following positive CHMP opinion and U.S. FDA Accelerated Approval.

European Commission grants conditional marketing authorization for Iqirvo® (elafibranor), a first-in-class treatment for primary biliary cholangitis (PBC), following positive CHMP opinion based on ELATIVE phase III trial data. Iqirvo demonstrated significant efficacy over placebo and was well-tolerated, reinforcing Ipsen’s commitment to advancing medical innovations for rare cholestatic liver diseases.

GENFIT reports €61.6M cash and €59M revenues, including a €48.7M milestone for Iqirvo® (elafibranor) U.S. launch. Positive EMA opinion for Iqirvo in July 2024, with a potential €26.5M milestone upon European approval. CEO highlights Iqirvo's U.S. approval and anticipates European decision by year-end. ACLF franchise progresses, with VS-01 Phase 2 data expected in 2H24. MASH diagnostics recognized in new European guidelines. Corporate governance updates include new appointments. Financial outlook includes expected milestone revenue and strong financial position.