9/22/2022

speaker
Frédéric Blanc
Co-Founder & Chief Executive Officer, Inventiva

Thank you and welcome everybody to this half-year webcast. As usual, some disclaimer, we'll be making forward-looking statements, so please have a look at our regulatory filings that are available on our website. In terms of speakers, I would say we have the classical Infinitiva team, myself and Pierre, the co-founders of the company. We have Michael, our CMO, and Jean, our CFO. But today is a special day for Inventiva, given the very recent partnership we signed with CenoBioPharm online in February. We are very pleased to have with us Philip Duong, head of the investment, who will give us an overview of CenoBioPharm activities. In terms of agenda, I'll give an highlight of the activity over the past six months, and then I will share the floor with Philippe, with Pierre, with Michael, to provide a pipeline update. We will move to the financial section with Jean, near-term catalyst, and then we will open the floor for Q&A. So, moving now to the highlight section, we start first with Lani, our phase three drug in non-alcoholic steroid hepatitis. A lot of key important milestones have been reached in the past six months. In terms of native three, we have expanded in 24 countries, and we have now activated close to 300 sites. And in the presentation, we give you a bit more details on the improvement in terms of cytotoxin. Very pleased, as I mentioned in my introduction, of the very recent collaboration we signed with SinoBioPharm and the expansion of Lani in Greater China, a country that we see is really promising from a commercial point of view, given the prevalence of NASH among the Chinese population. Some of the figures or the key figures of the collaboration are highlighted here, the upfront, the total milestone, the royalties, and we'll get a bit more in detail in the presentation. In terms of recruitment, we have had to announce a delay of the inclusion of the last patient to H22023, despite all the improvement in terms of site opening, country opening, site activation. But we see that all the action that we have launched still have not fully paid out. Especially we are still encountering a screening failure higher than expected and this has led to this delay. As you know, we have two other very important phase two that are ongoing, one that we call Legend, which is a combination of learning with impacted clothing. We started the screening, opening site and randomizing patients as planned first in the United States, but we also secured Regulatory approval in activation in the other countries where this study is taking place. And then we're pleased with Professor Cusi's ability to enroll the last patient in the trial over the summer, a bit later than anticipated. And therefore, results are not expected in H2, but in Q1, 2023. Moving now to Cedirogan, DBBB157. They are now, we say, we're expecting with a lot of excitement the result of this face-to-be in patients with psoriasis, which are expected in H1 2023. This is, I would say, an update for this conference. We have had over the summer an important meeting with the FDA. We're very pleased with the outcome. and the feedback provided with the FDA. We know that we can go directly now into children age of 5 to 14 with MTS6. We know that the design we presented to the FDA, which is a single, six, two, three trials, can potentially support marketing application. This gives us confidence in the search of opportunities to find a new home for the parcel, and really seeing this feedback provided by the FDA really goes into the right direction for this project. Finally, on the financials, we've been continuing to reinforce our cash position, both with dilutive and non-dilutive sources. We've had close to 15 million euros through a combination of the market program, which I remind you is managed by Jefferies, and it's only made of reverse inquiries, and also some non-dilutive funding coming from state-back financing from the French state. We also are very pleased from the European Investment Bank loan that we secured, a $50 million loan and warrant agreement of two tranches of 25 and 35, and we're pleased by the fact that with the upfront that we're expected to receive from our part of the CINO, we will be able to secure the first branch from the IB and this would extend our cash runway to Q4 of 23. And then lastly, also the recognition of being selected by Euronext as part of the Euronext tech leader. So this important index is also a nice recognition of the work that has been done. Let's now move to Lani. I just would like, first, before entering into the detail, give a bit of an overview of the competitive landscape in NASH. It's nice to see that, you know, positive news happening in the field with the recent data from AKIRO and others. Now, when we look at the landscape, I think all eyes are pointed to the part one, phase three results that are expected from West Meteorome. And then you see that from this slide, you see that Lani is really well positioned in terms of timing of when the results will be available, and we're really part of this Limited number of promising compound that are now in phase 3 or planning to enter into phase When we look at, you know, the competitor, I think we can divide them into two sections. We have the oral drugs and the injectables. When we look at the oral drugs, they're really extremely well positioned as the only oral drug that has met the two important endpoints that are considered by the FDA and NEA for approval for national resolution and improvement of fibrosis. There is another section where you have injectables with the recent data from ACCURE where they too managed to secure eating both and boys with a different that we highlight here. Our results are based on ITT population that as you know is a population that is considered by regulatory authority for approval and there we have statistical significance on both endpoints where the results presented by competitors are mostly based on per-protocol population, or even when you consider Acura, some completers. So now let's move to Lani, and before we get into Native 3, I would like just to give some of the highlights of the licensing and commercialization agreement we signed recently, and then I'll give the floor to Philip for the presentation of SILA. Why we were really excited by this opportunity is because China and Greater China is, in terms of NASH population, very attractive. Of course, less population, but also when we look at the prevalence of NASH, there are publications, an increasing number of publications that show that the prevalence of NASH among this population is close or sometimes even superior to what is experienced in the United States. Secondly, we're also excited because when we look at who is currently in development, in China, we see that only semaglutide out of the compound that I described before is present with a compound that you know isn't injectable and that has not been able to show interface to be in preserotic patient, but also in the serotic patient has not been able to show an antifibrotic activity. We really believe Lani, especially with a partner of the quality of Sinobiopharm, It's really well positioned to be potentially a leader in this, in the Nash field in China. In terms of financial, these are the highlights that have been described in the press release, so an upfront, an expected upfront of $20 million. Followed by short term clinical milestone that could potentially. A trigger an additional 5,000,000, and then globally the contemplates. The total of 290 million dollars of clinical regulatory commercial life. In terms of royalties, there is a first period of three years where to sustain, to help on the launch, the royalty will go from high single digit to mid single digit, and starting from the fourth year, from low double digit to mid single digit. Then in terms of regulatory, in terms of development strategy, there are several options that needs to be discussed, especially with regulatory authorities. Two main options seem, you know, viable. One would be for, you know, BioPharm to join the Global Native 3 study, or the other alternative would be to run an independent study. Important to point out, of course, that all the costs linked to the development in Greater China will be borne by our part. So with that, I'll give the floor to Philip, that will give us a quick overview of SinoBioPharm, and therefore I'm moving to page 14 of the presentation.

speaker
Philip Duong
Head of Investment, SinoBioPharm

Thanks, Federick. Just to check if you can hear me.

speaker
Frédéric Blanc
Co-Founder & Chief Executive Officer, Inventiva

Perfectly.

Disclaimer

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