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Inventiva (IVA) investor relations material
Inventiva Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Industry and market outlook
MASH field has seen recent clinical successes, two drug approvals, and three acquisitions, validating commercial potential.
Market opportunity estimated at over 15 million MASH patients in the U.S., with 375,000 addressable in F2 and F3 stages.
Diagnosis rates are rising due to new drug launches and increased disease awareness.
Many patients are expected to be on a GLP-1 backbone, with oral therapies layered on top.
Lanifibranor is positioned for use especially in diabetic F2/F3 patients due to metabolic benefits.
Company evolution and strategy
Underwent recapitalization in October 2024, extending cash runway and enabling strategic hires.
New leadership team with deep experience in drug approval and commercialization was assembled.
Focused on fundraising and building a team capable of executing late-stage trials and commercialization.
Cash runway extends to Q3 2027, contingent on positive phase III data and a third funding tranche.
Company is preparing for potential independent launch, with flexibility for strategic partnerships.
Clinical development and trial design
Phase III trial for lanifibranor is fully enrolled, targeting F2 and F3 MASH patients.
Trial design: randomized 1:1:1 to placebo, 800 mg, or 1200 mg daily, with 1,009 patients in main cohort.
Exploratory cohort includes about 400 F1/F4 patients, with 100 F4, to inform future outcomes trials.
Dropout rate is below 30%, within conservative powering assumptions.
Data cleaning and database lock are underway, with top-line data and NDA filing anticipated in the second half of the year.
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