3/8/2022

speaker
Operator
Conference Operator

Good day and thank you for standing by. Welcome to Inventiva's 2021 full year 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, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded and if you require any further assistance, please press star 0. I'd now like to hand the conference over to your first speaker today, Frederic Rennes. Please go ahead.

speaker
Frederic Rennes
CEO

Thank you and welcome everybody to this full year financial results presentation. As traditional, I would say, I will share the floor with Pierre, our CSO. We'll go over Lani Fibrenor. Michael, our CMO, also will present the clinical studies, the Phase II, done by Professor Cusi, and the legend study, while Pierre will cover an update on the Phase III. and then we'll end up with Jean, our CFO, who will give more granularity on the figures. But before we go into the details of the clinical update, I just would like to provide some of the key highlights of 2021, which I think has been, when you look at everything that has been achieved, quite successful. So if we start with Lani, So we had committed to start the native phase 3 pivotal study, which we did. And on top of that, we also announced the design of the legend study, our combination study between Lani and SGLT2 inhibitor impact deflosing. And this morning, you've seen that we have received a positive feedback from FDA and the IND application has been accepted by the diabetes division. The interaction With FDA, I would say overall during the year has been very positive. Some highlights are certainly the fact that the fast track which we had secured for patients with F2, F3 has been extended by FDA to cover patients with compensative cirrhosis. We're also extremely pleased by confirmation, the feedback we got from FDA concerning the tox packets which FDA consider as adequate and complete. to file an NDA in Nash. This is extremely positive because it means that, you know, we tick another box on the way to commercializing land. We also continue to prepare and complete our package for filing, and we positively concluded a QTC study where land demonstrated no impact on current electric activity. and finally, as you all know, we had this fantastic publication by the New England Journal of Medicine of the study of the Phase IIb native study. So that's the highlight for Lani, but then I would say 2021 for us was the year of Fedirogan with, you know, the completion of the Phase Ib and especially we're very proud and excited to see AbbVie moving forward with this trial, confirming that they've seen Umira-like efficacy that they believe that Cedirogan could be an efficacious drug in psoriasis. And their decision to move to phase 1B because, you know, the data of the phase 1B were available in April and I think in November the phase 2B started. So that's quite a fantastic accomplishment by the AbbVie clinical team. and that, of course, is a direct translation in terms of science because it triggered the 4 million milestone when the first patient in the Phase IIb was included in the study. ODI-Parson, we continue preparing for a meeting with the FDA. The objective is to validate with FDA the design of a pivotal trial, which we think is key in finding a new home for ODI-Parson. Other highlights, you know, on the back, less visible, we opened Inventiva Inc. in the U.S. where we also now have an important sizable clean-up team, you know, to follow our native Phase III study. We also reinforced the team with several recruitments in all departments and also reinforced the board with the arrival of Martine Zimmermann. On the financials, Jean will cover that in In detail, but we're very pleased of being able to activate an at-the-market program of a total envelope of 100 million. Approximately 30 million have already been used to satisfy the reverse inquiry of long-term investors.

speaker
Michael
Chief Medical Officer

And the cash-run rate, which runs through Q1 2017.

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