Inventiva S.A. Q4 FY2020 earnings call

["Landing lead program in NASH: Lanifibranor had breakthrough designation, FDA confirmed toxicology package is complete for NDA filing. NATIVE 3 trial for lanifibranor starting soon. Odiparcil in MPS: Focus shifted to NASH, evaluating strategic options for odiparcil. Cedirogant (ABBV-157): Exciting program, expected clinical proof-of-concept in Q2 2021 with slight delay due to COVID. Opened U.S. subsidiary for launch of Phase 3 of lani in NASH, building team there. Reinforced cable network and collaboration with Dr. Sanyal. Strong cash position with cash runway through Q4 2022 from capital increases, IPO, and government agreement. Lanifibranor details: Pan-PPAR agonist with unique profile, positive results in NATIVE Phase 2b trial, including histological endpoints met, effect on biomarkers, and favorable safety profile. Phase 3 trial design for lanifibranor in NASH with composite primary endpoint of NASH resolution and fibrosis improvement, global study with specific inclusion and exclusion criteria, and extension period for clinical outcomes. Profiling studies for lanifibranor in NASH compensated cirrhosis and combination therapies with other drugs."]

No specific product segments with revenue contribution percentages provided. Key programs include lanifibranor in NASH, odiparcil in MPS, and cedirogant (ABBV-157). Lanifibranor showed positive results in Phase 2b NATIVE trial with histological endpoints met, and odiparcil is being evaluated for strategic options. Cedirogant (ABBV-157) is in a Phase 3 trial with a slight delay due to COVID situation.

["Lanifibranor Phase 3 NATIVE 3 trial timing: Site initiation in Q2 2021, first patient first visit planned for Q3 2021. Odiparcil: Expect update on strategic options in 2021. Cedirogant: Expected clinical proof-of-concept in Q2 2021 with slight delay due to COVID. Cash runway through Q4 2022 with comfortable cash position."]

["Potential delays in clinical trials due to COVID-19, as seen in other trials. Uncertainty in strategic options for odiparcil. Dependence on successful regulatory approvals and clinical trial outcomes for lanifibranor and cedirogant."]

Q: Talk about timelines and COVID impact on trials, and potential options for compensated cirrhosis with lanifibranor.

A: COVID impact on trials is taken into account, with adaptation of clinical research methods. For compensated cirrhosis, aim to study lanifibranor in patients with normal liver function, focusing on clinical outcomes like decompensation.

Q: Clarity on Phase 3 timelines, cash run-rate including milestones, and central histopathology review in Phase 3.

A: Phase 3 timelines are realistic with selected CRO and team reinforcement. Cash run-rate does not include anticipated milestones. Central histopathology review with two expert pathologists was discussed and agreed with FDA.

Q: View on cedirogant program, its use in plaque psoriasis, and differentiation from others.

A: Cedirogant has potential in plaque psoriasis and other indications. Differentiated by ROR-gamma mechanism, oral once-daily pill, and higher safety due to shorter life.

Q: Short-term clinical efforts for lanifibranor in compensated cirrhosis and combination therapies, and R&D spending in 2021.

A: Short-term clinical efforts include exploratory studies. R&D spending in 2021 is expected to increase with Phase 3 trial ramping up.

Q: Biomarkers study for lanifibranor, potential companion diagnostic, and rationale for combination with SGLT2.

A: Biomarkers study aims to identify biomarkers for histological response. Rationale for combination with SGLT2 is for improving efficacy and managing weight gain.

Q: EMA's thinking on biomarkers, commercial differentiation of cardiovascular benefits, and enrollment updates.

A: EMA supportive of biomarker development. Cardiovascular benefits differentiated by improving glycemic control and dyslipidemia. Anticipate communication on key events like first patient first visit.

Q: Data expected from AbbVie on cedirogant's clinical proof-of-concept and stratification in Phase 3 NASH trial.

A: AbbVie to report data including biomarker efficacy at 4-week. Phase 3 NASH trial stratified by F2-F3 status.

Q: Surrogate primary endpoint confidence in lanifibranor, rationale for two doses in Phase 3, and cash runway coverage for Phase 3.

A: Confidence in surrogate endpoint due to consistent biology. Rationale for two doses for flexibility and efficacy evaluation. Cash runway covered by exploring licensing, regional deals, and other creative approaches.