NATiV3 Enrollment Completed
Enrollment for the global Phase III NATiV3 trial was completed in April 2025, exceeding original targets with just over 1,000 patients in the main cohort (company referenced ~1,009) plus an additional exploratory cohort of ~410 patients (F1–F4). Trial is randomized, double-blind, placebo-controlled and run over 72 weeks.
Clear Top-Line Readout Timing
Company updated top-line readout timing for NATiV3 to Q4 2026, reflecting sequencing of clinical and biostatistical milestones.
Strong Cash Position and Financing Events
As of December 31, 2025 Inventiva held EUR 230.9 million in cash, cash equivalents and short-term deposits. 2025 financing highlights include ~EUR 108 million net proceeds from the 2024 structured financing tranche and ~EUR 139.4 million net proceeds from a U.S. registered public offering.
Cash Runway Guidance
Based on current operating plan, company estimates cash runway to mid-Q1 2027 (and to mid-Q3 2027 assuming full exercise of tranche 3 warrants which could generate up to an additional EUR 116 million).
Pipeline Focus and Asset Monetization
Company strategically concentrated resources on lanifibranor for MASH in H1 2025 and sold global rights to odiparcil to Biossil in Q4 2025; potential consideration includes up to $90 million in regulatory/commercial milestones plus potential high single-digit royalties if odiparcil is approved.
Phase II Efficacy and Regulatory Designations
Lanifibranor demonstrated statistically significant improvement in the composite endpoint (fibrosis improvement and MASH resolution) in Phase IIb NATIVE; 1,200 mg dose showed a 24% treatment effect at 6 months in company commentary. FDA granted lanifibranor Breakthrough Therapy and Fast Track designations.
Trial Powering and Robust Operational Metrics
NATiV3 is powered >90% for the composite primary endpoint with the final main cohort size. The trial’s early termination/dropout rate was confirmed to be below the pre-specified 30% covenant threshold tied to prior financing tranches, leaving leadership confident the trial is well powered.
Commercial and Regulatory Readiness & Leadership Strengthening
Company strengthened leadership and commercialization/regulatory capability with hires including a CMO/President R&D (Jason Campagna), EVP Head of Quality & Regulatory Affairs (Martine Zimmermann) and Chief Commercial Strategy Officer (Nazira Amra). Pre-commercial investments increased (Marketing & BD EUR 5M) and NDA preparations are underway.
Large Addressable Market and Diagnosis Trends
Management reiterated an estimated ~18 million people in the U.S. with MASH (only ~10% diagnosed), noting diagnosis estimates grew ~25% vs. 2024. Among diagnosed patients with clinically actionable F2/F3 disease, only ~40% are currently under care, indicating substantial unmet need and growth opportunity—~375,000 patients estimated currently under care for F2/F3 in the U.S.
Differentiated Product Profile & Ancillary Benefits
Lanifibranor is a pan-PPAR designed to target hepatic and extrahepatic drivers of MASH; Phase II data showed HbA1c lowering (average ~>0.5 percentage points across population), triglyceride lowering and HDL increases—attributes management highlights as attractive for diabetic F3 patients.