Inventiva (IVA) Q4 2025 earnings summary

Executive summary

• Strategic focus shifted to advancing lanifibranor for MASH, with all resources and leadership aligned behind this objective.

• Fully enrolled pivotal Phase III NATiV3 trial for lanifibranor in MASH, with topline results expected in Q4 2026 and potential U.S. launch in 2028 if approved.

• Divested global rights to odiparcil, securing up to $90 million/€90 million in potential milestones and royalties.

• Revenues for 2025 were €4.5 million, down from €9.2 million in 2024, mainly from milestone and license payments.

• Leadership team strengthened with key hires and board changes in R&D, regulatory, and commercial strategy.

Financial highlights

• Cash, cash equivalents, and short-term deposits totaled €230.9 million as of December 31, 2025.

• Net loss for 2025 was (€354.1) million, compared to (€184.2) million in 2024.

• R&D expenses for 2025 were €87 million, reflecting pipeline prioritization and NATiV3 enrollment completion.

• General and administrative expenses rose to €47.9 million, mainly due to €20.3 million in share-based compensation.

• Net cash generated by financing activities totaled €241.3 million, mainly from structured financing and a U.S. public offering.

Outlook and guidance

• Cash runway extends to mid-Q1 2027, or mid-Q3 2027 if warrants are exercised, potentially adding up to €116 million.

• Topline Phase III data for lanifibranor anticipated in Q4 2026; NDA filing planned for H1 2027.

• Focused on NDA preparations, early commercialization groundwork, and capital-efficient operations.

• No plans for aggressive commercial staffing until positive data is available.