Inventiva (IVA) Corporate presentation summary

Lanifibranor profile and Phase 2b results

• Oral pan-PPAR investigational therapy designed to address intra- and extra-hepatic MASH drivers through balanced PPAR-α/δ/γ activation; received FDA breakthrough therapy and fast track designations.

• In NATIVE, the 1,200 mg arm achieved the composite of MASH resolution and ≥1-stage fibrosis improvement in 31% vs 7% with placebo; p<0.001 across all patients.

• In the F2/F3 subgroup, composite response was 24% with 1,200 mg vs 21% with placebo; in patients with T2D, it was 29% vs 26%.

• Phase 2b biomarker findings spanned liver, glucose metabolism, cardiovascular risk and fibrosis pathways, including a 4.5x increase in adiponectin.

NATIV3 pivotal trial and milestones

• NATIV3 main cohort enrolled 1,009 patients with noncirrhotic MASH and F2-F3 fibrosis; 72-week treatment compares once-daily 800 mg and 1,200 mg doses with placebo.

• Primary endpoint is the composite of MASH resolution and ≥1-stage fibrosis improvement; sample size was powered at 90%, with stratification by fibrosis stage and diabetes status.

• Last patient last visit was completed; topline results are expected in Q4 2026.

• Planned milestones include a potential U.S. regulatory filing in H1 2027, CACLD outcomes-trial initiation in 2027 and a potential U.S. launch in 2028; timelines depend on data, regulatory review and capital.

• Intended FDA accelerated and EMA conditional approval filings are subject to positive Phase 3 histology results; a confirmatory trial is planned in compensated advanced chronic liver disease due to MASH.

Market opportunity

• Estimated U.S. population includes 18M people with MASH, ~1.9M diagnosed patients, 910K diagnosed F2/F3 patients and ~374K F2/F3 patients under treatment.

• Diagnosed and F2-F3 patient pools were projected to grow 20-25% vs 2024; expected F2/F3 MASH market size is >$15B by 2035.

• Potential positioning targets patients with advanced fibrosis and patients at higher risk of progression associated with cardiometabolic factors.