Inventiva (IVA) Piper Sandler 37th Annual Healthcare Conference summary

Key objectives and recent progress

• Successfully completed a fundraising round, strengthening the balance sheet for upcoming milestones in 2026.

• Fully enrolled the Phase III NATiV3 trial for lanifibranor in MASH, with a data readout expected in the second half of next year.

• Expanded the management team with experienced leaders in clinical, regulatory, and medical roles.

• Preparing for market entry of an oral therapy for F2/F3 MASH patients.

• Planning a study in compensated F4 cirrhotics to meet regulatory outcome requirements.

Clinical development and study design

• NATiV3 is a large, global Phase III trial with 1,900 patients, including a higher proportion of diabetics and F3 patients.

• The study uses a co-primary endpoint (MASH resolution and fibrosis improvement), minimizing placebo response and aligning with regulatory expectations.

• Biopsy handling and reading protocols follow industry standards, using consensus reading and blinding.

• AI-based histology is included as an exploratory add-on, not part of the primary endpoint.

• The trial includes a significant cohort on baseline GLP-1 therapy, enabling future analysis of combination effects.

Competitive landscape and product positioning

• Lanifibranor is expected to be the third agent to market after Rezdiffra and semaglutide for MASH.

• GLP-1s dominate early-stage (F1–F3) MASH, but compliance and antifibrotic effects are limited.

• FGF21s target F4 but face challenges in F3 due to toxicity and administration route.

• Lanifibranor offers both antidiabetic and antifibrotic benefits, with a strong effect size in Phase IIb data.

• Expected to be competitive for both diabetic and non-diabetic MASH patients, especially in F3.