Inventiva S.A.

Good day and thank you for standing by. Welcome to Inventiva's first half financial results presentation. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session over the phones, you'll need to press star 1 on your telephone. Please be advised today's conference is being recorded. And if you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Frederic Crenn, Chairman, CEO and co-founder. Please go ahead.

Thank you and welcome. Good morning, everybody. Good afternoon and welcome to the first half of 2021 financial results. So as usual, I'll be making and the team will be making forward-looking statements, so please refer to the regulatory filings that are available on our sites or at the SEC or at Euronext. Today I'll be, of course, sharing the presentation with Pierre, Pierre Broqua, our CSO and co-founder, and Michael Korman, our CMO, who will be presenting the latest on Lani Fubanor. I will be speaking and introducing some very exciting news concerning our partnership with AbbVie and the recent progress of CDIrogan, and Jean, will be presenting, of course, the financials and our financial situation for the first half of this year. So without losing too much time, let's look at what are the highlights of this very busy first half. So if we turn, you know, to what was our ambition at the beginning of the year, we wanted and our goal was to have a pipeline by the end of the year with a Compound, Lanny Fubranor in Phase 3, and Cediro Gant in Phase 2B. And I think we are in a very well position to achieve both goals. So Lanny Fubranor, you have seen that recently we have announced that we have started screening in the U.S. with our partner, global partner, ICON-TRA, and that we have qualified more than 330 sites in 25 countries. So we are really pleased by it. by the launch of this exciting phase 3, and Michael will provide more background on the design and how the study is running out. The good news also comes from Cedirogan, ABBD 157. So you followed during the Q1, ABBD Q1 result that they communicated to have achieved a clinical proof of concept during the phase 1B in patients with psoriasis. and we were extremely pleased and happy to see that on September 14th on clinicaltrial.gov had been posted the design of the upcoming S2B with Cedurigan in patients with psoriasis. Very important study, 200 patients, 45 sites and especially they have confirmed that the study will be up and running in November which should trigger a milestone payment for us. and of course we are already looking forward to the result of this important study which are scheduled for March 23. Concerning the parcel, we're continuing actively on the evaluation of the strategy of the best options to continue moving this program forward. We'll not be able to update the market in 2021 and we plan to do that in 2022. Concerning the other important events, of course, We have been able to launch a phase three also because we have been able to reinforce our team on both sides of the Atlantic. Michael is now leading the team in the U.S., all devoted to the phase three. And also in France, we have reinforced our key position, both in terms of support function, medical cleanups, and we're really geared and prepared for this phase three. Over the summer, we've put in place an ATM, you know, as expected and as many biotech listed on NASDAQ do and this gives us an additional flexibility in order to reinforce our cash position with the possibility to exercise ATMs up to 100 million. And then finally, we have reinforced our board with the arrival of Martine Zimmermann, who will provide and is providing valuable regulatory expertise given her position currently at Alexion AstraZeneca. So this was for the short intro, and now I will give the floor to Pierre, who will give a brief update on Lani Sievert.

Thank you, Frédéric. So, hello, everyone. So, as you know, Lenny Fibonor is a pan-PPR agonist, which is currently in clinical development phase three for the indication, treatment of NASH, and improvement in liver fibrosis. It has an unprecedented structure and pharmacological profile. It's a pan-PPR agonist with moderate and well-balanced activity across the three isoforms. It's not a tazolidin dione and it's not a fibrin. This program has recently obtained breakthrough therapy designation as well as fast-track designation from FDA. And FDA has also confirmed recently that the non-clinical toxicology package is complete and acceptable for an NDA filing. So can we go to the next slide, please? So following the successful outcome of the native phase 2b trial with laniflubinol in NASH, we have started our phase 3 in patients with NASH and the Fibrosis score of F2 or F3. and Michael will present the details and the key milestones of this study. To complete the clinical development plan of lanifubinor in NASH and besides the study in collaboration with Professor Cusi, evaluating the effect of lanifubinor on liver insulin resistance in diabetic patients with NAFOD, We are also progressing on the preparation of additional clinical studies evaluating the potential of lenishubinol in NASH-compensated cirrhosis, and this on the back of positive preclinical findings that we have recently published. And we are also progressing in the preparation of studies to evaluate the potential of lanifubenol to be used in combination with other therapies and this to further strengthen its value proposition. So the Native 2 trial, next slide, sorry. So the Native 2 trial indicated that after 24 weeks of treatment, The 1200mg dose had a significant effect on improvement of fibrosis by at least one stage and no worsening of NASH. And both doses, 1200 and 800mg, had a significant effect on resolution of NASH and no worsening of fibrosis, as well as on the composite endpoint of resolution of NASH and improvement in fibrosis where a responder is defined as a patient showing both NASH resolution and improvement in fibrosis. Additional analysis were performed and communicated earlier this year at ESOL. And this analysis indicated that in patients with NASH and F2, F3 fibrosis, Lani-Schubiner also showed significant efficacy on the composite endpoint. and this group observed more than three and more than four times more responders in the low and high-dose group respectively. We also observed in this subgroup of patients with S2 and S3, leisure fibrosis, that markers of lipid metabolism, insulin resistance, liver injury, inflammation, and fibrosis also improved with treatment compared to placebo. We'll go to the next slide, please. So based on the NATIF-2 data, clearly Lanifibonov showed key differentiating benefits compared to the current competition, and particularly on insulin resistance and on fibrosis, which are, as you know, two important pathological features of NASH, and the latter, fibrosis, being, as you know as well, the primary determinant of clinical disease progression in patients with NASH. Next slide, please. This can be seen on this slide and compared to the current competition. Lanifuganor is the only drug having achieved statistical significance on the key regulatory histological endpoints of NASH resolution without worsening of fibrosis, and fibrosis improvement without worsening of NASH, and this with more than 40% responders for both regulatory endpoints. We'll go to the next slide, please. So with the native two results, We conducted interviews of hepatologists across U.S., U.K., Germany, and France. And these interviews indicated that the physicians valued length-of-life efficacy on multiple endpoints, as well as its once-a-day oral mode of administration. Next slide, please. The physicians also perceived weight gain as acceptable, considering the benefit on multiple disease endpoints, and suggested that weight gain could be offset with either proper patient counseling around weight loss or by combination therapy with, for example, GLP-1 receptor agonist or SGLT2 inhibitors. With that, I will now leave the floor to Michael, who will say a few words on native 3.