Inventiva S.A. Q4 FY2022 earnings call

• Lead program lanifibranor in NASH: NATiV3 Phase III ongoing with over 350 active clinical sites and >300 screening patients; implemented measures to boost enrollment, including reviewing biopsy analysis, training sites, incentives, site networks, and protocol improvements. Developed patient-centric design for NATiV3, approved in key countries like the US. - Partnership with Sino Biopharm secured ~€13M upfront payment with potential milestones up to €290M. - ABBV-157 program halted by AbbVie; odiparcil had constructive discussion with FDA allowing move to children's trials. - Financial activities: Secured €50M loan from EIB, raised ~€10M from ATM program, and additional facilities. Selected for Euronext Tech Leaders segment and welcomed new board member Dr. Lucy Lu. - Phase II trials: Professor Cusi's study on NAFLD and Type 2 diabetes completed enrollment, results expected in Q2 2023; LEGEND trial ongoing evaluating lanifibranor and empagliflozin combination.

No specific product segments with detailed financial performance and revenue contribution % provided in the transcript.

• Aim to achieve last patient first visit for NATiV3 in second half of 2023. - Expect results from Professor Cusi's study by middle of Q2 2023. - NATiV3 timeline: Last patient last visit in first half of 2025, top line data in second half of 2025, NDA submission for accelerated approval with FDA in early 2026.

No specific risks or operational failures explicitly discussed in detail in the transcript.

Q: Hoping to know if there will be a disclosure of baseline characteristics of patients in the Phase 3 trial and how Phase 2 results will be presented.

A: Frédéric Cren mentioned disclosing baseline characteristics could be feasible, and Michael Cooreman stated results from Professor Cusi's study will be in a press release with top line results and presented at scientific conferences including liver and endocrinology conferences.

Q: Bigger picture on Phase 2 trials, envisioning how combinations play out in real world.

A: Frédéric Cren and Michael Cooreman discussed lanifibranor's suitability for patients with NASH and Type 2 diabetes, inclusion of patients on stable GLP-1 doses in NATiV3, and LEGEND trial's role in providing data on combination benefits.

Q: Disclose number of patients enrolled in NATiV3, total target for outcomes trial, and dose for outcomes trial.

A: Frédéric Cren mentioned working on enrollment with improving screen failure, Michael Cooreman stated outcomes trial target is ~800 patients, and dose for outcomes trial not yet decided but will be chosen considering clinical pharmacology and NATiV3 data.

Q: Clarify LEGEND study's statistical analysis plan and impact of biopsy pathologist change.

A: Michael Cooreman explained LEGEND study based on HbA1c effect size from NATiV2 and power calculation, and the biopsy pathologist change was to improve consistency and tiebreaker process without major impact on trial outcome.