Inventiva (IVA) investor relations material

Clinical development and trial progress

• NATiV3 trial for lanifibranor in MASH is fully enrolled, with last patient visit completed and top-line results expected in Q4 2026.

• Phase IIb data showed 18% placebo-adjusted fibrosis improvement, 26% MASH resolution, and 24% on the composite endpoint in six months.

• Phase III design closely mirrors phase II, with conservative powering and over-enrollment to ensure robust results.

• The primary cohort for the upcoming readout will focus on F2 and F3 patients, with exploratory F1 and F4 data possible but not guaranteed.

• Confidence in replicating phase II results is high due to similar patient populations and statistical design.

Differentiation and mechanism of action

• Lanifibranor is a balanced pan-PPAR agonist (alpha, delta, gamma), designed to minimize tolerability issues seen with older PPARs.

• Demonstrates partial agonism at gamma, reducing fluid retention and edema compared to traditional TZDs.

• Shows strong effects on adiponectin, glucose control (A1c reduction), and lipid profile, impacting both intrahepatic and extrahepatic disease drivers.

• Biomarker data largely tracks with histology, though some non-invasive measures like FibroScan may be affected by fluid retention.

• Efficacy in both metabolic and fibrotic pathways positions it as a differentiated oral therapy.

Market opportunity and commercial strategy

• MASH market is rapidly expanding, with potential to exceed $15 billion by 2035.

• Initial adoption expected in F3 diabetic patients, with market expansion tied to efficacy levels above 18%.

• GLP-1s are becoming foundational in MASH treatment, and lanifibranor is expected to be used alongside or after these agents.

• Physician education will focus on PPAR tolerability and patient management, leveraging existing familiarity among GI, hepatology, and endocrinology prescribers.

• Company is preparing for independent commercialization, with recent leadership hires and sufficient funding through NDA filing and potential approval.