Inventiva (IVA) Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary

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.