Inventiva S.A. Q4 FY2024 earnings call

• Lanifibranor's Phase 3 NATiV3 closed screening in early January 2025, targeting H1 2025 recruitment completion and topline results in H2 2026.
• LEGEND combination proof-of-concept trials with lanifibranor showed positive results, including reduction in HBA1C, improved insulin sensitivity, and mitigation of weight gain with empagliflozin.
• Partner Hepalys launched Phase 1 study of lanifibranor in Japan.
• Reinforced team for regulatory and commercialization of lanifibranor.
• Strengthened governance with appointment of new board members, including Mark Pruzanski as Chairman.
• Raised approximately $184 million in gross proceeds from various financing operations in 2024.

In 2024, revenues were $9.2 million, derived from milestones with CTTQ. Other income was $5.5 million, stable compared to 2023. R&D expenses were $19.9 million in 2024, a 17% decrease from 2023 due to operational delays, but expected to increase as recruitment for NATiV3 resumes. Marketing and business development expenses were $2 million, stable. G&A expenses were $15.8 million in 2024, a slight increase from 2023.

• Anticipate announcing completion of randomization and release of second tranche of $127 million in 2025.
• Cash runway guidance: can operate until September 2025 without second tranche of financing, and until September 2026 with it.
• Plan to file NDA for lanifibranor in the first half of 2027 with an outcome study underway at the time of filing.

• Workforce reduction of approximately 50% due to focusing resources on lanifibranor development.
• Dependencies on successful completion of clinical trials, regulatory approvals, and timely receipt of financing.

Q: Are the patients on background doses of GLP1 low-dose diabetic doses or include high-dose for weight loss? How many patients are enrolled on background SGLT2 inhibitors?

A: GLP1 is mostly anti-diabetic dosing. Between 6% to 8% of patients are on SGLT-2 inhibitor at baseline.

Q: Confidence in completing enrollment for securing €116 million capital increase? Interest from pharmas?

A: High confidence in completing enrollment by H1 2025. There is significant interest from pharmas due to the MASH market's growth potential and lanifibranor's unique profile.

Q: What could derail last patient randomization? Market position of lanifibranor?

A: Delays in patient screening processes could derail, but confidence remains. Lanifibranor is the only oral Phase 3 drug in development, with a robust data set and potential to be a game-changer for MASH patients.

Q: Thoughts on R&D expenses, workforce reduction, and potential milestone receipts?

A: R&D expenses decreased in 2024 but expected to increase as recruitment resumes. Milestones from Chinese partner CTTQ may include further receipts.

Q: Timing of top line data and Hepalys Japan program funding?

A: Top line data expected after last patient visit, with a couple months delay. Hepalys funds all clinical development in Japan.

Q: Design and timing of outcome study for NDA filing? Powering assumptions for NATiV3?

A: Outcome study must be underway at NDA filing, planned for H1 2027. NATiV3 is powered at 90% using data from Phase 2B.

Q: Plans for Lani and SGLT-2 combo study? Importance of weight gain mitigation?

A: No plans for fixed dose combo, but data shows combination mitigates weight gain, important for obese MASH patients.