Inventiva S.A.

Good morning, good afternoon, everyone, and thank you for joining Inventiva's full year 2025 financial results and business update. Our press release was issued yesterday evening, and this webcast and slides will be available in the investor section on our website following the call. Joining us on the call today are Andrew Obenshain, Chief Executive Officer, Jean Voletier, Chief Financial Officer, and Dr. Jason Campagna, Chief Medical Officer and President of R&D. I would like to remind everyone that statements made during today's conference call and during the Q&A session may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Please refer to slide two of the slides and our SEC and AMF filings for a discussion of associated risks. These statements reflect our views as of today and should not be relied upon as representing our views at any later date. With that, I will now turn it over to Andrew, starting on slide three.

Andrew? Thank you, David. Good morning, good afternoon to everyone, and thank you for joining us. Since joining Inventiva six months ago, I've been struck by the depth of scientific conviction behind lanofibrinor and the dedication of this team. Today, every resource, every decision, and every member of this team is now aligned behind a single objective, advancing lanofibrinor towards approval for patients with MASH. Let me start with our main focus, our global phase three clinical trial, Native 3. Enrollment was completed in April 2025 and represented a landmark operational milestone for this company. Today, we are updating the expected timing of our top line readout to Q4, 2026, reflecting the disciplined sequencing of our clinical and biostatistical milestones. We believe that the data from the Native 3 trial, if positive, has the potential to carry weight with regulators, physicians, and most importantly, with patients. And we believe we are running this program with the rigor and precision all stakeholders deserve. On our pipeline and organizational focus, in the first half of 2025, we made the strategic decision to concentrate all of Inventiva's resources on land of Fibonor and MASH. As part of this plan, in Q4 2025, we sold our global rights to Oda Parcel to Biasil. And we may receive up to $90 million in potential regulatory and commercial milestone payments, as well as potential high single-digit royalties on future net sales, if approved. While this transaction frees up our internal resources to fully focus on land of Fibonor, we are pleased that Oda Parcel has found a new home where its development can continue, potentially offering patients with MPS6 an opportunity for treatment. At the same time, we strengthen our leadership team to align with the level this opportunity demands. Jason Campagna joined as CMO and President of R&D. Martine Zimmerman joined as a new EVP and Head of Quality and Regulatory Affairs. And Nazira Amra joined as our Chief Commercial Strategy Officer. We are building towards launch in a lean and targeted way, advancing our readout and NDA preparations while laying the early groundwork for commercialization in anticipation of potential approval of lanofipinor. And the opportunity is real. MASH has been underdiagnosed and undertreated for too long, but that is changing. More patients are being identified, more are being diagnosed and entering care. Awareness is growing, screening is improving, and metabolic disease is finally getting the attention it deserves. The numbers tell that story clearly. There are an estimated 18 million people in the U.S. living with MASH, but only around 10% have been diagnosed, and that number has grown by 25% compared to 2024 estimates. Among those diagnosed with clinically actionable F2 or F3 disease, only around 40% are currently under the care of a treating physician. So while diagnosis rates are improving and the market is evolving, Far too many patients with significant fibrosis remain without the care they need and face a real risk of progression to cirrhosis and liver failure. If our Native 3 trial can replicate the 18% fibrosis improvement seen in Phase 2, we believe lanofibinor could be well-positioned as a potential best-in-disease oral therapy with significant commercial impact. Ultimately, our goal is to make a meaningful difference for patients, and that is what drives everything we are doing. I will now turn the floor over to Jason, who will give a brief update on lanofibrinor, our differentiated oral antifibrotic, and a potential new treatment option that we believe addresses the remaining unmet medical needs in MASH.

Thank you, Andrew. Good morning and good afternoon, everyone. Let me start by reminding you of the mechanism of action and the development pathway of lanofibrinor. Lanofibrinor is a small molecule designed to induce anti-fibrotic, anti-inflammatory, and beneficial vascular and metabolic changes by activating all three PPAR isoforms, alpha, delta, and gamma, in a balanced manner. This broad mechanism of action is designed to target the hepatic and extrahepatic drivers of MASH simultaneously and in one oral therapy. Lanifribinor was the first asset to achieve statistically significant improvement in the composite endpoint of both fibrosis improvement and MASH resolution in our Phase IIb native trial after just 24 weeks of treatment with a favorable safety and tolerability profile. On the basis of these results from our Phase IIb, the FDA granted Lanifribinor both breakthrough therapy and fast track designations. Native 3, our pivotal phase 3 clinical trial, was designed to confirm and extend those findings in a larger, more diverse global population over 72 weeks and is intended to provide the data to enable successful marketing authorization in the United States and Europe. Native 3 is a randomized, double-blind placebo-controlled trial in patients with biopsy-confirmed MASH and stages F2 or F3 fibrosis, the core of the MASH treatment population, those with significant disease burden, and a high risk of progression to cirrhosis, liver failure, and liver-related mortality. We specifically chose a clinically meaningful primary endpoint for Native 3, fibrosis improvement and MASH resolution. And at six months in our Phase 2b, the 1,200 milligram dose of lanofrubinol showed a 24% treatment effect. Native 3 was also deliberately designed to mirror the patient population of our positive Phase 2b and the real world as it exists today. A meaningful proportion of our patients have type 2 diabetes and other metabolic comorbidities, and a number are on background GLP-1 and or SGLT2 inhibitor therapies, mirroring the patients physicians actually see in their clinics, which we believe will ensure that we generate clinically meaningful data to support both NDA and MAA submission. In April of 2025, we completed enrollment, exceeding our original targets with over 1,000 patients in the main cohort and an additional 410 patients with MASH and fibrosis stages F1 through F4 in an exploratory cohort. We anticipate sharing the top-line results of our pivotal Phase III trial in Q4 of this calendar year. a moment I believe will be significant for this field and for the patients who need new treatment options. I will now turn the floor over to Jean for a financial review.