Announcement • Sep 09

Inventiva Presents Multiple Abstracts on Lanifibranor At Paris MASH 2026

Inventiva announced the presentation of five abstracts at the 12th Paris MASH Meeting taking place September 10-11, 2026, at the Pasteur Institut in Paris, France. The abstracts present Phase 1 and Phase 2 clinical and preclinical data that further characterize the pan-PPAR pharmacological profile of lanifibranor and evaluate its potential effects on systemic metabolic dysfunction associated with MASH. Clinical data from Phase 1 and Phase 2 trials demonstrated direct PPAR target engagement, as reflected by increases in adiponectin, together with improvements observed in measures of insulin sensitivity, glycemic control, lipid parameters, and selected cardiovascular risk factors, with effects observed in patients with or without Type 2 diabetes. Separate preclinical studies demonstrated improvement in hepatic and metabolic parameters, and further characterized lanifibranor’s balanced pan-PPAR pharmacology, supporting a differentiated fluid and cardiac profile within the PPAR class. Lanifibranor is currently being evaluated in the Phase 3 NATiV3 clinical trial for the treatment of patients with MASH with moderate and advanced fibrosis, with topline results expected in the fourth quarter of this year. Following are the details of the poster presentations on September 10, 2026: Abstract Title: Beyond The Liver: Cardiovascular Effects of The Pan-PPAR Agonist Lanifibranor in Patients With MASH, Publication Number: 1256, Authors: S. Francque, A. Holleboom, J. Campagna, S. Hogan, G. Wettstein, M. Abedelmalek; Abstract Title: Metabolic Benefits of Pan-PPAR Agonist Lanifibranor in Patients With and Without Type 2 Diabetes, Publication Number: 1249, Authors: A. Holleboom, M. Abdelmalek, S. Hogan, J. Campagna, G. Wettstein, S. Francque; Abstract Title: Lanifibranor Improves Metabolic and Histological Features of MASH Across Multiple Preclinical Models: Convergent Pan-PPAR Activity, Publication Number: 1255, Authors: A. Holleboom, S. Francque, J. Campagna, S. Hogan, G. Wettstein, M. Abedelmalek; Abstract Title: Lanifibranor Phase 1/2A Experience – PPAR Engagement and Metabolic Activity Without Early Clinical Fluid Retention, Publication Number: 1254, Authors: A. Holleboom, S. Hogan, J. Campagna, G. Wettstein, M. Abdelmalek, S. Franque; Abstract Title: Partial PPAR Agonism Underlies Lanifibranor's Preclinical Fluid/Cardiovascular Safety Versus Full and Dual PPAR Agonists, Publication Number: 1344, Authors: S. Francque, A. Holleboom, J. Campagna, S. Hogan, G. Wettstein, M. Abedelmalek. Lanifibranor, Inventiva’s lead product candidate, is an orally available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (“PPAR”) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARa and PPARd, and a partial activation of PPAR?. Lanifibranor is the only pan-PPAR agonist in clinical development for the treatment of MASH. Inventiva believes that lanifibranor’s moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and preclinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH. Lanifibranor is an investigational medicine and has not been approved for use by any regulatory authority. Its safety and efficacy have not been established.

Announcement • Sep 03

Inventiva Completes Last Patient Visit In NATiV3 Phase 3 Clinical Trial Of Lanifibranor In MASH

Inventiva announced the last patient has completed their final 72-week visit in the NATiV3 Phase 3 clinical trial evaluating lanifibranor for the treatment of patients with MASH with moderate and advanced fibrosis. NATiV3 enrolled 1,009 adults with biopsy-proven non-cirrhotic MASH and F2/F3 fibrosis, with an additional 410 patients enrolled in an exploratory cohort. With the last patient having completed their final visit, all patients have completed the 72-week treatment period. Inventiva expects to report topline results from NATiV3 in the fourth quarter of 2026. If the results are favorable, the Company anticipates regulatory submission in the first half of 2027 and is preparing for a potential U.S. launch of lanifibranor in 2028, subject to FDA approval. NATiV3 is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the long-term efficacy and safety of lanifibranor (800mg/daily and 1200mg/daily) in 1009 adult patients with biopsy-proven non-cirrhotic MASH and F2/F3 stage of liver fibrosis. The effect of lanifibranor will be assessed on several histological endpoints, including MASH resolution and improvement of fibrosis of at least one stage after 72 weeks of treatment. An exploratory cohort has enrolled 410 patients with MASH and F1 through F4 stage of liver fibrosis. Following completion of the 72-week treatment period, patients participating in NATiV3 had the option to continue into a 48-week open-label extension period, during which all patients, including those originally randomized to placebo, receive active treatment with lanifibranor. This extension will provide additional information on the longer-term safety of lanifibranor. Lanifibranor, Inventiva’s lead product candidate, is an orally available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (“PPAR”) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARa and PPARd, and a partial activation of PPAR?. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in clinical development for the treatment of MASH. Inventiva believes that lanifibranor’s moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and preclinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH. Lanifibranor is an investigational medicine and has not been approved for use by any regulatory authority. Its safety and efficacy have not been established.

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Inventiva Presents Multiple Abstracts on Lanifibranor At Paris MASH 2026

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