Inventiva(US:IVA)2026-02-11 19:02Summary of Inventiva's Conference Call Company Overview - Company: Inventiva (NasdaqGM:IVA) - Event: 2026 Conference at Guggenheim's Emerging Outlook Biotech Conference - Key Speaker: CEO Andrew Obenshain Industry Context - Industry: MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) - Market Potential: The MASH market is evolving with recent clinical successes, including two approvals and a billion-dollar market potential for F2 and F3 patients. The diagnosis rate is increasing, with over 15 million patients in the U.S. and 375,000 addressable patients in F2 and F3 categories [2][10]. Core Points and Arguments - Clinical Trials: Inventiva is preparing for a Phase 3 trial readout for lanifibranor, a pan-PPAR agonist targeting F2 and F3 patients. The trial is fully enrolled, and data cleaning is underway [3][8]. - Market Positioning: Lanifibranor is expected to be used alongside GLP-1 treatments, with a significant effect size of 18% after 6 months compared to 12% for Rezdiffra after 12 months [11][12]. - Patient Demographics: The patient population is split between non-diabetics (40%) and diabetics (60%). Lanifibranor is particularly beneficial for diabetic patients due to its ability to reduce HbA1c levels [10][12]. - Trial Design: The NATiV3 study is designed conservatively, allowing for a dropout rate of up to 30%, with current rates below this threshold [13][14]. The trial includes a randomized design with a focus on both fibrosis and steatosis improvement [16][18]. - Safety and Tolerability: Lanifibranor is a novel chemical entity designed to mitigate historical safety concerns associated with PPARs. Weight gain is a potential side effect, but 50% of patients experience no weight gain, and 20% have modest gains [30][32]. Additional Important Insights - Strategic Partnerships: There is a cautious sentiment in the pharmaceutical industry regarding PPARs due to past experiences. However, positive Phase 3 data could overcome these concerns [41]. - Future Trials: Inventiva plans to conduct an F4 outcomes trial with lanifibranor, focusing on patients with portal hypertension [42][43]. - Cash Runway: The company has structured its finances to support operations through Q3 2027, with a potential third tranche of funding of EUR 118 million contingent on positive trial data [55]. Conclusion Inventiva is positioned to make significant strides in the MASH market with lanifibranor, backed by a strong clinical trial framework and a clear understanding of market dynamics. The upcoming Phase 3 data will be crucial for the company's future and potential partnerships.