Good day and thank you for standing by. Welcome to the Inventiva 2022 Half Year Results and Webcast. At this time, all participants are in listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please note that today’s conference is being recorded. I would now like to hand over to your speaker, Mr. Frédéric Cren, CEO and Co-Founder. Please go ahead. Frédéric Cren: Thank you, and welcome, everybody, to this half year webcast. As usual, some disclaimer, we will 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 imperative team, myself and Pierre, the Co-Founder of the company; with Michael, our CMO; and Jean, our CFO. But today, it’s a special day for Inventiva given the recent partnership we signed with Sino Biopharm lanifibranor. We are very pleased to have with us Philip Duong, Head of Investment, who will give us an overview of Sino Biopharm activity. In terms of agenda, I will give an highlight of the activity over the past six months and then I will share the floor with Philip, 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 will start first with lani, our Phase III drug in non-alcoholic steatohepatitis, NASH. Importantly, a lot of improvement, a lot of key important milestones has been reached in the past six months. In terms of NATiV3, we have expanded in 24 countries and we have now activated to 300 sites in the trial and in the presentation, we will give you a bit more…

Thanks, Frédéric. Just to check if you can hear me. Frédéric Cren: Perfectly.

Perfect. Okay. Thanks, Frédéric, and thank you for the Inventiva team during the collaboration discussions and sort of a fruitful outcome and we look forward to sort of collaborating with Inventiva in the long-term going forward. So I will give a quick background on Sino Biopharm and I am currently looking at page 14. So Sino Biopharm, for those of you that don’t know Sino Biopharm, we are one of the largest, actually, if not the largest Chinese pharmaceutical group in China. We are listed in the Hong Kong Stock Exchange since 2003. We currently have a market cap of slightly over US$10 billion and then last year, we had revenues of US$4 billion. Globally, we are ranked the 40th largest pharmaceutical globally by Pharm Exec’s, which is the largest in China, as I mentioned. So through our subsidiaries, we operate a fully integrated pharmaceutical operations from discovery to clinical development to manufacturing and sales. We started up as generics back in the ‘80s and we have moved towards innovation in the last decade. So we have significant R&D capabilities with over 68 innovative assets in the pipeline and seven of those are focused on liver diseases. We also have U.S. and EU qualified manufacturing capabilities in API, small molecules and biologics. I think from a commercialization perspective for lani, it’s quite important to note that we have the largest sales reps -- sales and marketing reps in China with over -- with almost 14,000 reps covering basically the entire Chinese or the entire China. And we both do it through traditional sales channels, so the hospital sales channels, as well as emerging channels such as online channels, as well as the pharmacy chains.In hepatology, we have a proven track record with over 17% market share, and this is from…

Thank you, Frédéric. As you mentioned, there are two studies that are in Phase II. One is on slide 20, a study that aims to provide more information on data on the mechanism of action of lanifibranor as a fund agonist in patients who have not only have type 2 diabetes to conditions that occur often in the same patient, given the similar underlying disease biology. Specifically, this study aims to show that lanifibranor decreases intrahepatic triglyceride content, improves any cirrhosis, specifically the insulin sensitivity thereof and also insulin sensitivity in hepatic and muscle tissue, which is a core mechanism of action of Hippo signaling, endogenous hepatic glucose production and markers of cardiometabolic health. The investing the principle is one type study and sponsor and principal investigators, Ken Cusi at University of Florida. The total of 34 patients with that of the type 2 diabetes are enrolled and to have reference values. There are also data from 10 healthy individuals who are non-obese and whose data will serve as reference. These volunteer participants do not receive investigational compounds. Sample size is calculated on the effect size of more than 50% reduction of intrahepatic fat, which is also based on data that are available for how [inaudible] work in this indication -- in this finding. The primary endpoint is a change in intrahepatic triglyceride 25 by MR spectroscopy and so baseline compared to 24. And in addition, there’s a lot of secondary endpoint that will provide a kind of a comprehensive picture on how lanifibranor improves metabolic health in these patients, starting from insilicosystems, NAFLD solution defined as patients with a very low intrahepatic triglyceride content, change in hepatic fibrosis measured with elastography, MRI-based and ultrasound based MRE and FibroScan, as well as biomarkers, and of course, also safety and tolerability…

Yeah. Thank you, Frédéric. So, yes, we are very excited to update you on the odiparcil program. But I just like to start with a recap on MPS and [inaudible] action on Page 27. So as you know, MPS are innovative disorders that are characterized by the dysfunction of lysosomal enzymes, which are required for the breakdown of glycosaminoglycans, the GAGs. Within this family of disorders, MPS VI is caused by mutation in ERT SBT [ph], which encodes the enzyme leading or responsible for the degradation of DS and CS. So MPS is actually an accumulation of DS, dermatan sulfate and chondroitin sulfate in all cells of the body. So then, of course, MPS is a devastating multisystem disease, which is actually leading to a reduced life expectancy up to only the teens or early 20s in the more rapidly advancing cases up to 40 or 50 in slower progressing cases. So today, there is one treatment approved, an enzyme replacement therapy, Naglazyme, which, however, has several limitations due to its poor distribution in the body. And there is, therefore, still a very important medical need for treatment of MPS VI, even in patients that are actually treated with ERT. So the next slide, please. So we have odiparcil, odiparcil is a small orally available molecule that decreases the CS and DS type of GAGs accumulation in disease cells. And this, as you recall, a very unique GAG clearance mechanism of action. On top of that, odiparcil is, of course, all available, well distributed and can penetrate difficult to meet tissues including cartilage bone and cornea, offering, therefore, an opportunity to address the clinical manifestations that are currently not treated by ERT. So we now have conducted a Phase III study called iMProveS in adult MPS VI patients that were…

So let’s go through the key financial figures. So -- and you will see it’s quite straightforward in continuity of the prior financial period. I will be happy to answer your question at the end of the meeting. On this slide, one important, obviously, information is the cash position. So as you can see, we maintained a reasonable level of cash versus the end of 2021. So we are at €87 million versus €95 million at the end of last year. So this prior to the consequences of the Chinese deal was allowing us to operate until Q2 2023, and as disclosed and explained the deal with the Sino Biopharm allowed to gather the conditions for reaching the first tranche of the EIB, and therefore, allow us to extend the cash runway through Q4 2023. Let’s go through next slide with the key evolution of the profit and loss account and cash flow. As I said, so no revenues for this semester. As a reminder, Inventiva recorded €4 million milestones from AbbVie in the accounts of last year. But we have been paid early this year and then have a positive effect on our cash flow for this semester. As usually, the key and stable information with regards to R&D investments, which represent more than 80%, still of our total OpEx is the increase in the R&D plus 56%, and it’s still due to the acceleration of the NATiV3 studies primarily and as you have seen some additional studies plus in a lesser extent. If you remember, we have this year a full semester of operation of our U.S. affiliate versus only one quarter in 2021, a reasonable increase [Technical Difficulty] due to the increase in personnel cost by due to the charge related to the share-based payment, which is…

Thank you. [Operator Instructions] We have the first question coming from the line of Ed Arce from H.C. Wainwright. Please ask your question. Your line is open.

Hi. Good morning. Can you hear me? Frédéric Cren: Perfectly Ed.

Wonderful. Thanks for taking my questions and congratulations on the deal with Sino Biopharm. I have three questions. First, you mentioned the recent results of Akero were a protocol versus ITT, which is more of a standard and the basis for your results in the Phase IIb. I was wondering if you could talk about how you view the differences of that data and as well your perspective on how the regulatory agencies view the differences of those two, that’s first? Second is, I wanted to ask if -- you mentioned with the Sino Biopharm deal that they could either join NATiV3 or decide to conduct its own Phase III trial. And I wanted to know if they -- if you and Sino decided to have that joined to NATiV3 trial, would that have any impact on the time line? And then lastly, the top line NASH results from NATiV3 looks like it’s still about three years away, second half of 2025, which based on your most recent runway creates about a two-year funding gap. So I am wondering if there are any additional opportunities for funding say from the results from AbbVie or perhaps initial funding from a future partnership on odiparcil? Thanks so much. Frédéric Cren: Thank you, Ed. So very, very cumulative question so oh I got to take off sorry. I will try again, sorry, can you hear me?

Yes. I can hear you fine. Frédéric Cren: Okay. Sorry, we just had a terrible echo here. So, on the first question, maybe Pierre and Michael will complete for me, the difference protocol versus ITT. I just think it’s important just because of Akero produce some slides where they used and compared the Phase II data, I think it’s important also to have a complete picture. And from what they said in their own presentation is that if they had used an ITT approach, they would have lost statistical significance on -- I think, on the NASH resolution one. And therefore, in that case, we could claim to be the only drug that has made will lead to both a regulatory endpoint. But nevertheless, I just think it’s important that we retain that because on the Phase III, what the regulatory authorities will be looking is the data from the ITT and the fact that we were able in the Phase IIb to be sustained on that population give us more confident or even greater confidence that we will succeed in our Phase III. Then I will ask the second question and Philip don’t hesitate to complete my answer. So your question was, in the event biopharm joins the NATiV3 would that have an impact on the time line. I would say that it’s too soon to mention that. It will certainly contribute and help in our recruitment effort because the patient that would be recruited in China would account in the patient needed for Part 1. But we are prudent and therefore, we do not -- we don’t take this upside in our projection. And then last, I don’t know, Philip, anything you would like to add to this?

Yes. Thanks, Frédéric, and thanks for the question, Ed. I think in terms of our clinical enrollment capabilities, I think we can quite quickly enroll patients. Obviously, it’s subject to multiple factors, simply CD regulatory approval and such. But I think once or if we do go down the route of a global multicenter trial. I think we are quite confident that our capabilities to sort of quickly open sites as well as leverage scale networks to sort of recruit the patients quite quickly to sort of not delay the timetable from Inventiva site. Frédéric Cren: Thanks Philip and then last question about the two-year funding gap until the Part 1 read out. I think there are two ways to read it -- it’s a glass of LT. We can also read given the difficult times in the market if Inventiva secured financing until Q4 2023. And also as you mentioned, I think we have several opportunities so that are both dilutive and non-dilutive -- on the dilutive, we have an APM open, and we have always benefited from the support of front enrollment. And then on the non-dilutive side yes, we are excited by the discussion with the FDA for the feedback, which according to us reinforces the rationale for odiparcil, continue develop in MPS VI and we have not changed our strategy. We do not want to develop odiparcil on our own. We think it’s a good candidate for partnering. Will we succeed it too soon to say, but the FDA feedback gave us confidence. And then also, I think lani is a very attractive compound, and there are other geographic areas beyond China where the bartering would make a lot of sense. And then finally, as the partnership in the short-term, we -- if they decide to move into Phase III, of course, this will trigger a milestone. But always like to receive it, but you know that we have always said that in this contract, what is really material are the royalties and not the milestone. But if next year, the program moving to Phase III, Inventiva will have a very promising asset like lani NASH and the drug in Phase III in psoriasis, maybe potentially other [inaudible] disease indication finance and carried out by AbbVie, so I really think an interesting value proposition to investors.

Great. That’s all right. Thank you. Frédéric Cren: Thank you. And I think we were expecting a question from Jeroen and we don’t hear him?

Hello. Frédéric Cren: Yes. We can hear you now.

Hi. Sorry, there seems to be echo here on the line. Congrats also from KBC with regards to the Sino Biopharma deal and with the results for odiparcil, maybe from my end and following up on the Akero a little bit. NASH clearly has been a little bit more of a challenge over the past years? Do you see renewed interest from investors, do you believe that also with more and more people refocusing on it, there will be non-invasive, let’s say, like diagnostic methods coming online? And maybe one last question -- you guys can give me or us an estimate of the NASH size in China? Frédéric Cren: All right. On the first question, I would say yes, in the sense that good news from other competitors like Akero and other are a positive for the space. I think we -- the failures of other compounds have -- and I don’t think it was justified shed a negative light on the successes of other and include that learning that. So yes, it’s very positive to see other companies succeeding because this provides a positive sentiment on the space and they really hope that continues. And this is why we are looking and cheering for Madrigal success in their face. On the non-invasive, maybe, Michael, do you want to just give an update on the recent progress there?

Absolutely. So, yes, and our focus on the FDA, the FDA this data requires histology as the target efficacy endpoint. I should say then that in the past, [inaudible] been quite some progress in the -- on data that are being generated, both from imaging and biomarkers and algorithms based on those as non-invasive markers for the disease and for response to treatment. And in these discussions to what extent they will be complementary to or in the future, be replacement for histology. We are all active part of that discussion, including our academic colleagues, R&D industry as well as the FDA, and I think that’s very good news. I think with regard to lanifibranor specifically, what gives us confidence is that lanifibranor given this mechanism of action has shown strong efficacy on the histology endpoint, but also in a broad range of biomarkers that reflect the disease as well. So I think in -- for both histology and IT, I think, lanifibranor has a very strong position. Frédéric Cren: Thank you. And the last question on the NASH size market in Greater China. Personally, I have not seen any forecast or any public data. The only data I have seen is what we mentioned before is about the prevalence that seems to be like higher or similar to the one in the U.S and then given the size of the Chinese population that makes it a very attractive market. I don’t know, Philip on your side, have you seen anything public on the market potential or anything you can disclose?

Yes. Sure. So, as you know, whenever we improved NASH treatments, a bit of an echo I will just go ahead. Yes, so without any NASH treatments, I think there’s quite a large range of numbers that we have seen from as low as sort of 2% to even as high as 6%, 7%. But like Frédéric, like he mentioned, I think it’s just the sheer size of the population with over 1.3 billion population that translates to quite a high potential NASH patients. We have seen numbers being thrown about 50 million patients or so. But again, without sort of any approved treatments, those numbers are hard to verify. But it is quite a large market in China for NASH. Frédéric Cren: Well, thank you. And then we have a question from Alex from Bryan, Garnier. The floor is yours.

I hope you can hear me well. Yes thanks for taking my questions. So I was just wondering if you could share a bit more on the screening failure in the Phase III. Like what would be the rate of failure you are seeing and kind of what measures are you introducing to reduce that failure. And are you already seeing kind of results in terms of faster enrollment on the back of those measures? Frédéric Cren: Yes. Enrollment, thank you. The screen failure rate is high, and we have seen that, first of all, happening across the type field of NASH clinical studies. So I don’t think what I know actually that all data are not in aberration with others, which is reassuring. So NASH is as many other indications challenging. Having said that, we actually have advanced a lot of efforts to detail the reasons for the screen failure rates -- and basically from satisfied every individual case. And overall, there are a couple of reasons, which I have to do with lab values of course, and also with the histology reading, which as you know, seen quantitative scoring system. And we have three expert pathologists. I think they are among the very best, if not the best in the field. We spent a lot of time bringing it together in the formal sessions that they can align the reading before we start looking at biopsy in our part of the study. And we have now also vented that’s recent, so it’s not possible to say what the impact will be, but I can estimate that from our previous results, of course, a system whereby each biopsy is set by two of these pathologists independent of each other. And if there is a non-alignment, say one scores fibrosis stage 3 and the other one at 4 or at 2 and at 1, then there’s a tiebreak. When tiebreak automatically will then define what score is align. And if I look back to the data that we had previously that will alleviate or increase the screen failure rate to a certain extent. In addition to that, we pay a lot of attention to providing guidance to sites to diagnose prescreen patients so that the likelihood that when a patient enters the screening process that the patient ends up being a screen failure is reduced. And with that, I think we have looked at published data as well as our own data. What are the criteria that would have the highest effect and it’s not -- it’s well known that aminotransferase, specifically as C phase [ph] we call that. So we have adapted our inclusion criteria accordingly, and will implement that as an amendment. And we can anticipate that these measures will have a measurable effect on the screen failure rate going forward.

Got it. That’s very helpful color. Thank you. And just a question on cedirogant if I may it seems like AbbVie is pretty excited about the compound given the speed of recruitment in the Phase IIb. But I don’t believe they have actually released Phase Ib results, which makes me believe there may be waiting it for AAD in March, but then they might also have the Phase IIb data. So do you have any insights into kind of their plan for releasing Phase Ib or Phase IIb data next year? Frédéric Cren: Well, you are right, the Phase Ib data has not been that if they share. The next important congress is in the early AAD in March opposite of March. That could be a date where they could publish for the results until the abstract is available is difficult to confirm that. And in terms of plan of it look more education of the Phase IIb, I don’t think this has been decided yet.

Got it. And on the back of the Phase IIb, are there any specific milestones you would expect in 2023, let’s say, maybe related to finalizing the study or relating to good results, obviously or is it related then to a start of Phase III? How can we think about that? Frédéric Cren: No. It’s related -- the milestones are -- directly combined for us will be beginning the initiation of the Phase III.

Okay. Okay. That’s all from me. Frédéric Cren: In any indication -- we don’t need to be psoriasis if we -- first patient enrolled in the first Phase III.

Okay. Understood. Thank you. That’s it from me. Frédéric Cren: Thank you. And then Delphine Le Louët from Société Générale is also online, and so very happy to. Delphine Le Louët: Yes. Hello. Hi. Good afternoon, good morning, everyone. Different question from my side, can you Fred, can you let us know exactly how many patients have been screened and enrolled so far or as of end of August, just for us to get an idea of the rapidity of the inclusion. And what sort of effectively ramp up, we can expect till the end of the last patient first visit in order to prevent any further delay or just to get an idea of what’s your goal and how we position ourselves towards that? Second question, deals with according to your knowledge of your Chinese partner and the Chinese market, can you give us a sort of a probability of what would be the scenario choose by the -- let’s say, by the Chinese? Would that be to go for a Chinese study or to come up and add up ramp for Chinese patient within the NATiV trial? And finally, I was wondering, can you remind us the other condition that you have from the EIB to unlock the other €25 million envelope? Thank you very much. Frédéric Cren: All right. To your first question about figures in terms of number of screen, screen failure all of that, we are not communicating on that. This is not done by our competitors. So we want to preserve our competitive advantage versus others, because -- the competitive market, what we can say that if you look at the number of sites, countries, so that we are, we say -- online we have our expectation, and that was not the case. The last time we had a webcast where we were facing a delay in terms of regulatory approval and in terms of opening of sites. So that was not the case. So that how that has been sort. And now clearly, for our team and ICON, is to go back to what Michael said is, we need to improve this screen failure rate that is high for us it’s high for everybody in the market, but we are fully care about them and we need to bring it down. On your second question about what the feedback from the China regulatory authorities will be on the approach. I frankly do not know because I have no experience with them. Maybe, Philip, you want to comment on that, but maybe right now, it might be a bit too speculative I don’t know - what would you say?

Yes. Thanks, Frédéric, and thanks for the question. I think it’s a bit too early to tell, but I think we will do what’s best for the quickest launch in China as well. Delphine Le Louët: Yes. I can imagine. But the idea is to know if Sino Biopharm has already been involved in such a deal. And so what was the solution chosen for the other company, if they were involved in such a deal partnering out-licensing, I mean licensing the right for Chinese market?

Apologies, I didn’t quite get the question. Is it how you would? Delphine Le Louët: No. I was wondering if Sino Biopharm already shared with you some of their experience from the past from other licensing deal they may have or any view that they have or any confidence that they have towards the regulatory passing in China?

Yes. Sure. So I think global multi-centers are joining our Phase III trial in China is in other therapeutic areas has been done before. And it’s -- I won’t say it’s common, but it’s done before and it’s resulted in sort of good risk -- it’s done well. But unfortunately for NASH, not that it’s never -- not that it’s been done before, but it’s new. So I think it will be the first global multicenter trial in NASH where if we do it, I think it will be a landmark situation. So for other therapeutics there is -- it’s been done before we have experience with that. Delphine Le Louët: Okay. And Frédéric the last question regarding the financing, yes? Frédéric Cren: Yes. For AAD the second tranche I will let Jean describe the competition.

Good afternoon, Delphine. Delphine Le Louët: Hi, Jean.

Yes. We have disclosed all information with regards to the CPs and the -- CPs condition precedent. I will not go in state, but you can go in the disclosures that have been made. The total condition to reach the second tranche in one year, more than one year from now because the objective is to raise second tranche one year after the first one is to get a cash injection of €70 million, okay including the initial cash injection that is required for the first tranche. Clearly speaking, we match we are on the way to match -- we have matched €9.5 million with ATM. We will match the $12 million euro with China. So mathematically, we missed €50 million to bridge. And as we have explained in terms of financial strategy, we will get other opportunities to bridge this €50 million. There are also other CPs like, as you may know, the warrant side of the deal because there are some issuance -- of warrants for each tranche. And there are some operational conditions also relating to mix of -- activated sites at the time of the raising, or a number of randomized patients, which is quite first reasonable in terms of negotiation with AAD and attainable within the current plan of development. Frédéric Cren: The last CP, which we have met, was to sign a partnering that we have done or as we entering Phase III. And I think we are [inaudible]. We hope that we will be -- able to meet the second potential condition. Delphine Le Louët: Thank you. Frédéric Cren: Very good. And then we have no more question on the phone, but we have some questions on the platform. Some have been covered, one has not been covered -- that can we disclose what, are the milestones beyond the €5 million [inaudible] this unfortunately we can. And then there is a question about the YAP-TEAD program, where do we stand there? And then I will turn to Pierre for our…

Yes. Sure. Thank you for the question. So yes, we are also very excited with the progress made with this project. We are actually working on very specific molecules, three compounds that are now into -- in vivo evaluation phase. And this compound differentiates quite well from other competitors like from Viva, Akina [ph], even Novartis in the middle inspection and the outcome being that those compounds are capable of inhibiting the proliferation of sales, the proliferation of which is dependent on the update. But also tested, and that makes a big difference our profiling and as it is something that’s communicated earlier this year. We have demonstrated that our Akina compounds acting on the small pockets of FTs are actually preventing the FTs association and preventing the proliferation of FT dependent sales, but are capable of preventing the proliferation of past-dependent sales. Our lead compounds do both, which opens the opportunity to address many more cancers and those are contact currently in vivo testing and looking forward for the in vivo data. Frédéric Cren: Thank you, Pierre. I think we have no more questions. Therefore, I would like to thank all of you for participating for your question. I would like to thank Philip for staying up late now because it’s -- more than 9 p.m. in China. Thank you and thank you for making yourself available. I think it was important to describe the capabilities Sino Biopharma. Otherwise of course, we will continue working and we look forward to the next meeting. I would also like to point out that today for us is a special day because we are actually just after this conference run to the celebration of the 10-year anniversary of Inventiva. We started this adventure 27th of August, 2012. And today, we are really pleased to be in a position to celebrate this important landmark for Inventiva on the back of positive news for lanifibranor and for odiparcil and also for cedirogant. Thank all of you for your participation, and I look forward to seeing you very soon. Thank you.