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Inventiva (IVA) investor relations material
Inventiva Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Piper Sandler 37th Annual Healthcare Conference summary3 Dec, 2025
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.
Target specialist strategy for launch
Fibrosis effect needed for market leadership
Is F4 cirrhosis study needed for F2/F3 approval?
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44th Annual J.P. Morgan Healthcare Conference14 Jan, 2026
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Frequently asked questions
Inventiva S.A. is a clinical-stage biopharmaceutical company focused on the development of orally administered small molecule therapies for the treatment of serious diseases. The company's research primarily targets conditions related to fibrosis, lysosomal storage disorders, and oncology. Inventiva leverages its proprietary technology platform to identify and develop novel compounds that modulate nuclear receptors, transcription factors, and epigenetic regulation. The company's lead products are developed through strategic collaborations with other pharmaceutical companies, aiming to advance these therapies through clinical trials and regulatory approval. The company is headquartered in Daix, France, and its shares are listed on the Nasdaq.
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