Good day and thank you for standing by. Welcome to the Inventiva 2022 Full Year Results Call and Webcast. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Please note that today's conference is being recorded. I would now like to hand over to your speaker, Mr. Frédéric Cren. Please go ahead, sir. Frédéric Cren: Thank you, operator, and welcome to everybody to this full year 2022 financial results. As usual, I will be making with my colleagues forward-looking statements. So please have a look at the regulatory documentation that is available on our website. In terms of speakers today, I'm very happy as usual to have Pierre with us our CSO and Co-Founder; Michael, our CMO, will go through an update of our three important clinical trials with lanifibranor, of course, the Phase III, but also two Phase II that are ongoing. And then Jean will conclude the presentation with an update on the financials. Of course, at the end of the session, we will have a Q&A session. So let me give you, first of all, some highlights for the full year. So let's start with our lead program, lani in NASH, and start with NATiV3, where we've been, I would say, very happy to work and extend, develop the Phase III in 23 countries. And now we have more than 350 clinical sites that are active and more than 300 that have screened at least a patient. We have throughout the year, and we continue to do so, implemented a series of measure to boost enrollment and I would say that this continues throughout 2023. We have done many things and we're very proud of those and grateful to our team. We have reviewed and implemented a…

Thank you, Frédéric, and good morning. Good afternoon to everybody. I'm on Slide 15 now, which summarizes the development program for lanifibranor. On the left in green, you have the completed study that was summarized by Frédéric just a minute ago, so the Phase II study and I would just highlight also that this was a six month treatment with a very robust efficacy on histology both NASH activity and fibrosis, which is a testimony to the efficacy of the compound to have that degree of – effect on fibrosis after a short treatment period for a fibrosis evaluation. Based on these data, the efficacy and the safety of the compound, the FDA has granted breakthrough therapy designation for lanifibranor in NASH. And on the right in orange, the Phase III study, which is currently ongoing. We are in the midst of the Phase III study as you know and I also speak about two earlier Phase II studies that Frédéric also mentioned on Slide 16. As you heard, we have updated the design of the study to make it more attractive to patients and investigators removed the seven-year placebo-controlled treatment period and have had very good interactions with the FDA on this change. And as you know, the FDA has also made public communications that correspond to the overall development approach that we currently have in place. So what are the main changes in NATiV3? The readout for the surrogate efficacy endpoint, which is histology after 72 weeks of treatment, has remained unchanged. We have two active arms, and a placebo arm and there will be two biopsies, one at baseline may be historical, but one biopsy at baseline and one at the end of treatment for a total of about 950 patients. After that, patients will remain in…

Good morning, good afternoon, everyone. So we will get to the key information on our financial landscape. Happy to answer, of course, your questions later on if you have further questions. So first of all, in terms of shelter base no significant change. It’s stable, and therefore Webex with our key partner. We have recently extend the – our coverage, our analyst coverage with Stifel came recently. I wouldn’t like to elaborate too much about our market cap, which appears disconnected from what is the potential of the lanifibranor assets, but at least at the moment, the consensus is still positive and at the significant spread process, the current market cap. In terms of financial statements, three takeaways to remind, first of all, in terms of revenues I guess it’s the first time we reach this level of €12.2 million in sales. And the good thing is it’s the same cash white, because we record it also this amount with the upfront from the CCTQ Sino Biopharm partnership in China, where we’re talking about. The second point important is the continuous effort, and we have seen some of the actions to boost the enrollment and continue to too much our operational target on 93. This explained the significant increase in R&D expense, and which should in 2023 continue this trend to reach the plateau could speed in 2023 expected too much again our objectives by the end of the year. And then third point in a very difficult market this year on the financial field, we have securitized a short-term close to €80 million principally with the European Investment Bank deal to – of €25 million. One, I’ve been raised on the first quarter, and we’ve also used our at the market program with $9 million plus also in June…

Thank you, sir. And the questions come from the line of Seamus Fernandez from Guggenheim Securities. Please ask your question.

Great. Thanks so much for the question. So a couple of quick questions. The first one is really hoping to know if there will be a disclosure of baseline characteristics of the patients now that the next or the first Phase 3 trial that’s going to readout in 2025 is likely – if those are likely to be presented and shared with investors. I think that’s definitely an important dynamic as we think about the differentiation of this clinical trial versus some of the other competitor opportunities. And then the second question is just what your hoped for results or the opportunity is to really share with investors the opportunity that you see from the Phase 2 clinical studies. I think Michael you provided a lot of detail in your prepared remarks. Just hoping to better understand what or how those results are likely to be presented, whether it’s in a press release with a sort of formal primary endpoint assessment or if it’s more kind of exploratory analysis that will be provided and perhaps presented at a medical meeting specifically. Thanks. Frédéric Cren: Thank you, Seamus. So maybe I’ll take the first question and then for the communication strategy of the Phase 2 with Professor Cusi maybe I’ll let Pierre or Michael summarize the discussion we’ve had with scan. Concerning your first question about disclosing the baseline characteristic, it’s actually a good suggestion. Honestly, we have not thought about that and we’re not able to answer, but yes, this is feasible that could be interesting to do. Of course, we have looked at the patient that has been enrolled, and Michael maybe can correct me, but from what we have seen is that of course, we’re not changing patient population from the previous Phase 2b. And so we really looking for patient, of course, F2, F3 with a moderate to severe level of inflammation and ballooning always selected with the same approach with an activity score of at least two or three. What we have seen is maybe a bit more patient with type 2 diabetes, I think with approximately 40% in the Phase 2 now. We’re more at 60%. So I don’t know what it is due to, I don’t think it’s – it means anything. We have seen that the drug is as efficacious in both populations on – patients with NASH or patients with NASH and type 2 diabetes. But otherwise, they are good suggestion maybe to disclose the baseline characteristics once we are fully enrolled. Maybe Michael or Pierre you want to talk about communication strategy for the Phase 2?

Yes, sure. For the study that is sponsored by University of Florida, we will have once the data are available and press release on the top line results. And then of course, the data – the details of the data, the primary efficacy endpoint and all the secondary efficacy endpoint will be presented made public at scientific conferences in the first place by Dr. Cusi’s team.

Great. And maybe just as one follow-up, should we anticipate those results likely in terms of the medical meetings that you would be targeting. Is that more of an EASD conference, just because this is a diabetic patient population or a little bit more along the lines of AASLD remaining focused on the liver focused patient population? I know there’s a blend of marketing to endocrinologists and to liver specialists.

Absolutely. And so we aim for both actually. And we are doing that now. We even – we have done a great deal of analysis of the metabolic immune markers of the NATIVE study and present those to both liver conferences, AASLD, EASL, but also to the ADA. We also have a presentation this year at ADA and with conclusion cause we will discuss that together. And the goal is to certainly also cover the endocrinology conferences, but that does not – we also stay active with the liver conferences. I think that’s enough.

Thanks so much…

Yes. Enough material to cover both conferences.

Okay. Thank you.

We are now going to proceed with our next question. And the questions come from the line of Annabel Samimy from Stifel. Please ask your question.

Hi, thanks for taking my question. And the tremendous amount of details that you’ve provided for the Phase 2. I guess I want to look a little bit bigger picture. When we think about the Phase 2 trials that you’re conducting is the intention to potentially make lanifibranor available to all patients you trying to gear it towards a type 2 diabetic patient, which it seems to have some tremendous benefit for and then also on the LEGEND trial. So you’re looking at it in combination with , but it seems that a number of these patients or a number of the physicians believe that these patients will already be on some kind of background with one. So I’m just wondering, again, bigger picture, how do you envision some of these combinations to play out in real world? And are you intending to try to find another combination treatment to optimize lani? Or is it to – that’s maybe oral and more suitable for the population that you’re targeting? Or is it just too potentially manage some of the weight gain issues or whatever optimize its profile in general? So I guess, I’m trying to understand how it works out with the GLP-1 as well as the combination trials that you’re looking at right now. Thanks. Frédéric Cren: Okay. So maybe on the Phase 3 for currently, of course, we have patient F2, F3 and we stratify for patient with NASH and type 2 diabetes. Clearly, our intention and our belief that lani addresses both population. So – and that has been shown in the Phase 2b, it’s effective in patient with NASH and it’s also effective in patient with NASH and type 2 diabetes. Where and why we work a lot on the anti-diabetic properties of lani is because…

Yes. So I think the – in these diseases, it’s also non-cardiovascular disease and diabetes treatment paradigms changes, new treatments become available, and semaglutide specifically or GLP-1 receptor agonists certainly have or changing that paradigm. And now that GLP-1 receptor agonists are becoming – have become first line treatment in type 2 diabetes. So I think that’s something that we adapt to. I don’t think – I think that’s actually an opportunity. I mean, we will – we do allow patients who are on a stable dose to be enrolled in NATiV3. We may also, since Frédéric refer to that, consider to get use that opportunity to update LEGEND if you wish. And that’s something that we are discussing. But I think lanifibranor remains a very distinct drug from the other compounds in that it has pan-PPAR agonist, it does have this effect on metabolism as well as on inflammation as well as on the fibrosis. And so for disease like NASH and type 2 diabetes that go hand in hand or approval will be for NASH, but many patients will have type 2 diabetes. And even those who don’t have over type 2 diabetes, many of those are – have pre-diabetes, which the diabetology community also recommends to treat. So this is an advantage I think that we have in the NASH field. And the – in fact that the treatment field for type 2 diabetes is changing something that we use to our advantage to position lanifibranor in combination with these newer treatments as well. So I think that’s how our studies are currently designed. And I think that lanifibranor will have an attractive position in this field.

Okay. Great. Thank you.

We’re now going to proceed with our next question. The questions come from the line of Ed Arce from H.C. Wainwright. Please ask your question.

Great. Thanks for taking my questions and congrats on the continued progress. A few for me. Firstly, just wanted to ask if you can disclose how many patients are currently enrolled in NATiV3. And then turning to the outcomes trial, I think you mentioned 900 patients is the total target, but I think there’s 800 on the slide, just wanted to confirm the total number there. And then lastly, also with outcomes, which dose of lani are you planning to use for that trial? And then I have a couple of follow-ups. Frédéric Cren: Okay. So let’s take the first two. I think on the outcome trial, disclose number of patient that we have randomized and enroll, we have not of course we monitor the situation daily, and we're very pleased with the enrollment, with the screen failure I mentioned. We have, let's say battled or anyway had to concentrate improving the screen failure, which was earlier than what we expected. That is something that is general in the industry, but we've been really working out and we see the screen failure going down for the past – regularly for the past several months. So that's very positive. As I mentioned, we have quite a large number of sites that are screening – and actively screening, so we – that gives us confident that we can meet our target of end of enrollment for the second half of this year. Then on the third question, on the dose may maybe Michael, you want to give highlight of the discussion we've had with FDA?

Yes. If I understand the question correctly, correct me if I'm wrong it was about the total number of patients that we enrolled in the outcome study. So our estimate is 800 – about 800 with two arms, one dose of lanifibranor and placebo. And the 950 or 960 is for the NATiV3. The study that you are currently running that is providing the data for accelerated approval. So, did I answer your question right?

Actually, Michael the question – the other part of the question was which dose would you be using, intend to use for the outcomes study? Which dose of lan?

No. We have not decided yet. But we will choose one dose. I think when we finalize the design we'll take all information into consideration, which includes the clinical pharmacology data, but also the data that we get from NATiV3 depending on where we are.

Okay. Great. And as a follow-up, I just wanted to ask for the, I think you mentioned at the beginning of your remarks some work that's been done more recently on speeding up biopsies. I wondered if you could expand upon those activities and what you've done and how that's helped the study. And then lastly, I just wanted to ask about the financials. I think you said cash right now is runway to the end of the year. If you could confirm that and also what's the remaining amount on the ATM? Thanks so much. Frédéric Cren: Okay. So on the biopsy process so has been many activities going on and improving that process that helped in the – in improving the screening process. So by spinning up, I meant that the process between making a biopsy in a site and the time it takes for the reviewer to give their appraisal, it's a long process. So I think we have now speed up and optimize that process. And then secondly, the big change we made is that, you know that we follow say the FDA guidelines to have a biopsy reviewed by three pathologists with a tiebreaker. We starting the trial with two pathologists involved, and if one of these two pathologists is agreed or did not evaluate in the same way as the other one, the biopsy, the patient would be excluded. And now we have introduced a tiebreaker also for the baseline. And so now when there is a disagreement between the two biologists, there is a tiebreaker that the pathologist that have the tiebreaker. So that that also has been introduced, and all along the way, also we have introduced training, alignment training between these three pathologies so that they really work as a team. That's also something that has taken us some time and we see now good alignment between these three pathologists. Then on cash, on all of that I led to Jean answer about the ATM and the cash.

Sure. So ATM, as we seen in the end of 2023, and very important without considering the second tranche of the EIB which present the – they say cartridge of €25 million. And we have still US$58-plus million on the shelf for the other market program.

Great. Thanks so much.

We are now going to proceed with our next question. And the question come from line of Frédéric Gomez from Pharmium Securities. Please ask your question. Frédéric Gomez: Thanks for taking my questions.

Frédéric Gomez your line is open. Frédéric Gomez: Thanks for taking the question. One of the NATiV3, yes, can you hear me? Frédéric Cren: Yes.

Yes. Frédéric Gomez: Yes. Can you hear me? Frédéric Cren: Hello. We hear you very well. Frédéric Gomez: Can you hear me? Frédéric Cren: Yes. Yes. Frédéric Gomez: Okay, perfect. Yes, perfect. So the first question is on the LEGEND study, the primary will be the HbA1c. Can you maybe clarify a little bit the statistical analysis plan or you will perform the analysis between the combo arm and the lani arm? Just yes, I'm just wondering how you will say that the study is positive because we should expect an effect on the primary if there are any around versus the placebo? And just to follow-up a little bit on this analysis of biopsies and the change in the number of pathologists that will have a look at the biopsies you started at two, now it's says three pathologist. Does it – I'm curious to hear you about the potential impact on the outcome and also the baseline data because this shift may have an impact of the role on the trial itself, if more patients have been looked by three pathologists versus two. Can you maybe elaborate a little bit more on the potential impact of this change? Frédéric Cren: Sure. So for the LEGEND we can start with that, and maybe even for the tiebreaker, maybe Michael you can address that.

Sure. Yes. I think to start with LEGEND we actually have based the sample size calculation on the power, on the data that we have from NATiV2 on the effect on HbA1c. I don't have in my head now but those numbers we have, and also on the additional benefit that you expect when you combine pioglitazone with one of the SGLT2 inhibitors. And as I mentioned there are four large randomized trials that give actually a consistent picture that you have an additional benefit on the decrease of HbA1c after half year of treatment or longer. But most of these studies was half a year. And that provides the basis to define an effect size as we should see, and a power calculation to have on a p-value that is adequate, that's what it's based on. Now, it is a proof of concept studies. So I like to point out that this is really because we – this is the way we do it, but the main importance of the study is really to show that there is an additional benefit of the combination on metabolic markers, for those patients who may need it, and also on weight for those patients who may find it important. I can only repeat that to weight gain with PPAR agonist distinct from weight gain that results from poor lifestyle. But that may still be an issue for patients who are obese not all patients with NASH or NASH and type 2 diabetes or obese. So it'll actually not be an issue for all patients, for some maybe, and this is what it's based on. So we really see the value of this study in providing that set of data on the additional benefits that the combination we have in certain patients for…

We have no further questions at this time. I hand back our conference to Mr. Cren for closing remarks. Thank you. Frédéric Cren: Yes. Well, thank you very much for attending. We have in front of us very exciting 2023, NASH the very exciting space. It was not the case last year and we see now a much more renewed interest. There're going to be quite a lot of events this year, especially with the FDA, the Intercept and the Madrigal submission. And concerning the lanifibranor will remain confident. We have in our – and the drive that can make it to the finish line. And this year, operationally we know we have to deliver on NATiV3. And as I mentioned it seemed that we're on the right track. And then we'll also be looking forward with optimism, let's say the crucial optimism to the data that will be generated by Professor Cusi in the type 2 diabetes study, and also of course in the LEGEND study, and that will keep us busy. And as usual, thank you very much for attending, and I look forward to seeing you – all of you in the future meetings.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect your lines. Thank you.