Inventiva S.A.

Good day and thank you for standing by. Welcome to Inventiva's first half of 2026 Financial Results Conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I would now like to hand the call over to David Nicodem, Head of Investor Relations for Inventiva. Please go ahead.

Thank you. Good morning, good afternoon. Thank you for joining Inventiva's first half 2026 financial results and business update. This morning, we issued our press release reporting our full financial results for the first half of 2026. A replay of this webcast will be available in the investor section of our website following the call. Before we begin, a quick reminder that the statements we make today, including during the Q&A, may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act 1995. These statements reflect our views only as of today and should not be relied upon at any later date. Please refer to slide two and to our filings with the SEC and the AMF for discussion of the associated risks. Joining me today are Andrew Obenshain, our Chief Executive Officer, Dr. Jason Campagna, our Chief Medical Officer and President of R&D, and Axel-Sven Malkomes, our chief financial officer. Chris Benecchi, our recently appointed chief operating officer, will be joining us for the Q&A portion of the call. With that, I'll turn the call over to Andrew.

Thank you, David, and welcome, everyone. Today, I'll start by providing an update on the company and our priorities. Jason will overview our land of Fibonacci development program. Axel will walk through our first half of 2026 financial highlights, and then we will open the call for Q&A. The first half of 2026 has been a defining period for Invitiva. We have stayed focused on our near-term objectives, advancing Land of Fibonor toward the Phase III top-line results readout in MASH expected in Q4 2026, preparing for regulatory filing while building the organization to support a potential commercial launch. Let me start with why we believe in the potential of Land of Fibonor and why a potential new therapy for MASH is so important. It comes down to three key elements, differentiation, late-stage validation, and market opportunity. Let's begin with differentiation. MASH is driven by both intrahepatic and extrahepatic processes, and lanafibinor is designed to address both through a single, once-daily oral therapy. In our native Phase IIb study, lanafibinor showed improvement across all key histological endpoints. Next is validation. We designed the Native 3 Phase 3 trial to build on the foundation established in our positive Phase 2B study. We look forward to reporting top-line data in the fourth quarter of this year. And finally, market opportunity. The market is being built in front of us. If Lambda Fibrinora is approved, we will enter an established therapeutic area with a market potential expected to exceed $15 billion by 2035. However, significant unmet need remains, and this represents a meaningful opportunity for Inventiva to bring a potentially differentiated treatment option with lantifibrinol to people diagnosed with MASH, if approved. Let me take each in turn and then lay out our priorities for the year ahead. Let's start with differentiation, and it begins with understanding the biology of the disease. MASH is not simply a liver problem. It is the hepatic expression of a broader systemic metabolic dysfunction. As slide 6 shows, the disease is driven by multiple interconnected pathways, both outside and inside the liver. These include insulin resistance, adipose dysfunction, and dyslipidemia on the extra-hepatic side, and steatosis, inflammation, and fibrosis within the liver itself. That has clear implications for treatment. If the disease is driven by several processes at once, there is an opportunity for next generation treatment to target more than just one driver. That is the unmet need we believe Lanofibinor could address if approved. Our aim is not only to target the liver, it is to modulate pathways across both the metabolic and hepatic components of the disease and bring a differentiated treatment option to patients with MASH. The differentiated mechanism of lanofibrinor modulating both pathways is reflected in compelling clinical data. In our Phase IIb study, after six months, lanofibrinor delivered an 18% placebo-adjusted improvement in fibrosis, 26% on MASH resolution, and 24% on the composite endpoint. Those results are the foundation for Native 3. We are now testing the same approach in a larger controlled Phase III population of patients with F2 and F3. That is what makes Natives 3 so impactful. It was designed to confirm, at pivotal scale, the biology and activity we observe in our Phase 2b study. And we are pursuing this in a market with substantial and growing unmet need. As slide 8 shows, there are an estimated 18 million Americans living with MASH, yet only 10% are diagnosed. That is changing fast. As the treatment landscape has matured, diagnosis has increased, up roughly 25% versus 2024, and that is translating into a larger population being actively identified and managed. Today, approximately 374,000 patients with F2 or F3 disease are already in treatment or under the care of a physician. The picture is clear. A large, prevalent patient population expanding rapidly as awareness and testing improve and a compelling opportunity for lanofibinor if approved. Turning to slide nine, to see where lanofibinor may fit in the treatment paradigm, it helps to think about MASH in terms of two factors that are top of mind for physicians, the severity of fibrosis and the cardiometabolic factors that can influence the risk of disease progression. Put fibrosis on one axis and cardiometabolic risk on the other. and four clinically distinct populations come into view. Start with the lower right quadrant. We have patients with F3 MASH and cardiometabolic risk, such as type 2 diabetes. This is a population with high unmet medical need, with the mechanism of action of lanofibinor to be compelling in that it targets both the liver and the metabolic driver simultaneously. In our Phase IIb trial, lanofibrinor demonstrated an 18% placebo-adjusted improvement in fibrosis at just six months. Similarly, in the lower left, although these patients have earlier stage F2 fibrosis, their cardiometabolic risk factors can put them at risk for more rapid disease progression. For these patients, physicians may also want to act urgently, and lanofibrinor could potentially offer an opportunity to intervene earlier in the course of the disease if approved. Moving to the top right quadrant, by extension, lanofibrinol could be well-positioned in patients with F3 fibrosis without significant cardiovascular risk. Here, the fibrosis itself is the primary concern, and lanofibrinol may have the potential to address the underlying liver disease before it progresses. Taken together, these three quadrants represent a large population with significant unmet need, and if approved, we believe lanofibrinol has the potential to play an important role in addressing the needs of these patients. With that overview of why we believe in the potential plan of Fibrinor, let me lay out three key priorities we are focused on to unlock new opportunities for patients with MASH. First, the Native 3 trial. We remain on track to report top-line data in the fourth quarter of 2026. Earlier this month, the last patient completed their final 72-week visit. The main cohort enrolled 1,009 participants, all with biopsy-confirmed non-cirrhotic MASH and F2 or F3 fibrosis. Second, regulatory readiness. We are advancing our preparations now to support a potential NDA submission with the FDA in the first half of 2027, positioning us to move quickly into regulatory interactions if the top line data readout is positive. And third, commercial readiness. We are building a commercial organization with the depth and breadth of experience with the best disease products to be ready for the potential launch in 2028. We believe we are moving forward with Lanifibinor from a position of strength and with a potential for a differentiated profile, a late-stage validation opportunity with Native 3, and a significant market opportunity if approved. I'm truly energized by the potential to make a real difference for millions of people living with this serious disease. With that, let me hand it over to Jason to take you through the science behind Lanifibinor and our clinical program. Jason.