IVA — Inventiva S.A.

Summary of Inventiva (IVA) Q4 2025 Earnings Call

1. Key Financial Results and Metrics

• As of December 31, 2025, Inventiva reported cash, cash equivalents, and short-term deposits totaling EUR 230.9 million.
• The company raised approximately EUR 108 million from a structured financing event and EUR 139.4 million from a U.S. public offering in 2025.
• Estimated cash runway extends to mid-Q1 2027, or mid-Q3 2027 with full exercise of tranche 3 warrants, which could generate up to EUR 116 million.
• R&D expenses for the year were EUR 87 million, reflecting prioritization of the lanifibranor pipeline.
• G&A expenses totaled EUR 47.9 million, including EUR 20.3 million in non-cash share-based compensation.

2. Strategic Updates and Business Highlights

• Inventiva is focused on advancing lanifibranor for the treatment of Metabolic Associated Steatotic Hepatitis (MASH) through its global Phase III trial, NATiV3, which completed enrollment in April 2025.
• The anticipated top-line results from NATiV3 are now expected in Q4 2026, reflecting a disciplined approach to clinical milestones.
• The company sold global rights to odiparcil to Biossil for potential milestone payments of up to EUR 90 million and royalties on future sales, allowing a concentrated focus on lanifibranor.
• A strengthened leadership team was announced, including key hires in regulatory, quality, and commercial strategy roles.

3. Forward Guidance and Outlook

• The company is preparing for a potential launch of lanifibranor, with ongoing regulatory and commercial readiness efforts.
• The management expressed confidence in the market opportunity for lanifibranor, particularly in the underdiagnosed MASH population, which has seen a 25% increase in diagnosed cases compared to 2024.
• The company aims to replicate an 18% fibrosis improvement observed in Phase II trials, which they believe would position lanifibranor competitively in the market.

4. Bad News, Challenges, or Points of Concern

• The timeline for the top-line readout from the NATiV3 trial has been pushed to Q4 2026, indicating a longer wait for potential approval.
• There are concerns regarding the dropout rates in the trial, although management confirmed they remain below the 30% threshold required for financing covenants.
• Competitive pressures from other companies, such as Madrigal, were acknowledged, particularly as they continue to see strong market uptake in the U.S.
• The company is aware of the challenges in ensuring the safety profile of lanifibranor, particularly regarding weight gain and fluid retention associated with PPAR gamma agonists.

5. Notable Q&A Insights

• Management confirmed that the dropout rate in the NATiV3 trial is well within acceptable limits, maintaining confidence in trial power.
• Discussions highlighted the potential for weight gain associated with lanifibranor, with expectations that it may plateau and could be mitigated by concurrent diabetes treatments like GLP-1 inhibitors.
• The exploratory cohort of F4 patients in NATiV3 aims to assess safety and potential biological activity, which will inform future outcome-driven trials.
• Management indicated that while they are not actively pushing for increased diagnosis of MASH initially, they are aware of the growing awareness and diagnosis rates in the market.
• The regulatory pathway for accelerated approval was clarified, emphasizing that a trial must be underway at the time of filing for conditional approval.

Overall, Inventiva is strategically positioned with a strong cash position and focused efforts on lanifibranor, but faces challenges related to trial timelines and competitive pressures in the MASH treatment landscape.