Good day, and welcome to the GENFIT conference call. At this time, I'll be turning the conference over to Ms. Stefanie Magner. Please go ahead. Hello, everyone, and thank you for joining us on this conference call organized to follow up on the press release we published this morning. The press release announced that we entered into an exclusivity agreement to acquire Versantis, a private Swiss-based clinical stage biotechnology company focused on addressing the growing unmet medical needs in liver diseases. It can be accessed via our website at ir.genfit.com. Joining me on the call today is Pascal Prigent, CEO. Before we begin, I'd like to remind everyone that statements made during this conference call, including the Q&A session relating to the group's expected future performance, market potential, business prospects, events or plans, including clinical plans, regulatory approvals, anticipated timelines for clinical development and study enrollments, including those of Versantis, conclusion of the agreement with Versantis, and expected cash used in our operational activities are forward-looking statements as defined under the US Private Securities Litigation Reform Act of 1995. They are based on our management's current assumptions and estimates, which although believed to be reasonable, are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in or implied or projected by the forward-looking statements. For a further discussion of the material risks and other important factors that could affect our business operations and financial results, please refer to those contained in our most recent filings with the Securities and Exchange Commission and the AMF. These forward-looking statements speak only as of the date of this webcast. Other than is required by applicable law, the company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events, or otherwise. Following the prepared remarks, we'll open up the call for questions that will be addressed by GENFIT management. Please limit yourself to one initial question to allow time for other questions. I now turn the call over to our CEO, Pascal Prigent. Thank you, Stephanie, and thank you everyone for joining today's call, during which I am going to expand on the announcement we've made earlier today. First, I'm going to explain how the acquisition of Versantis is a logical continuation of the implementation of a corporate strategy we first presented to you at the end of 2020. Then I will describe Versantis technology, assets, and programs to show you how they will expand and de-risk our pipeline. I will talk about the significant potential of each program and the synergies between the two companies. Finally, I'll touch on our expected news flow following the integration of Versantis, and then I would conclude with some financial considerations that are associated with the deal. Let's start with our corporate strategy. You might recall that in the fall of 2020, we presented a three-pronged corporate strategy. The first step was focused on urgently creating some financial room by significantly reducing our cash burn and restructuring our debt. This was completed by the end of 2020. The second step was to accelerate our remaining programs, and in particular focus on launching and fully recruiting our phase 3 in PBC. The recruitment was completed this summer, and we are on track to deliver high-level results in Q2 next year. The third part of our strategy was to pivot away from NASH and recreate an exciting pipeline targeting rare liver diseases. Let me elaborate a bit on how we intend to achieve this and what exactly is our R&D strategy. In the past 15 years, GENFIT has developed a strong expertise in drug development in the liver space. We have taken a drug candidate all the way from pre-clinical development to the end of phase 3. We did this in a therapeutic area where the absence of existing solutions meant that everything needed to be co-constructed with regulatory authorities and the medical community. We learned a lot in this process, and we built strong relationships with all key stakeholders. During these years, we also developed a deep scientific knowledge as well as networks and great academic partnerships in the field of liver diseases. It is this experience and accumulated knowledge that we want to leverage going forward. This is why we chose to focus on rare liver disease and in particular concentrate our efforts where the medical need is greatest. This medical need is characterized on the one hand by the lack of satisfactory therapeutic options and on the other hand by the severity of the disease. Furthermore, we look preferably at acute conditions where there is urgency to come up with a solution for the patient. This sense of urgency means that we can potentially have shorter developmental timelines, thanks to expedited regulatory pathways put in place by regulatory agencies in order to address patients' needs quicker. In order to be able to make a difference quickly, we have also chosen to not be a player in drug discovery, but instead focus our research on repositioning as well as potentially bringing in assets at clinical stage or close to it. In line with this strategy, in 2021, we advanced our repositioning of NTZ in ACLF into clinical stage, and we brought in GNS561, which is getting ready to start a phase 2 in cholangiocarcinoma. The decision last year to license out elafibranor to Ipsen enabled two things. First, the possibility to remain laser-focused on advancing our clinical programs and building our pipeline without having to spread ourselves thin by starting considerable pre-marketing efforts. Number two, that deal with Ipsen provided us with the financial flexibility to potentially fund acquisition if we found drug candidates and programs that fitted with the R&D strategy that I just exposed. We believe Versantis portfolio of programs gives us exactly what we are looking for. After the acquisition, GENFIT will have multiple promising programs in rare liver diseases and will be a global leader in ACLF, a therapeutic area that we feel is both important and underserved. Since ACLF is going to become such an important area of focus for GENFIT going forward, let me give you a little bit more insight about this condition. ACLF or acute on chronic liver failure occurs in the late stages of a pre-existing chronic liver disease, and that can be any disease. It can be NASH, alcoholic hepatitis or another liver disease. In the late stage of the liver disease, the patient will develop cirrhosis. An ACLF occurs when this cirrhotic patient experience an acute episode of hepatic decompensation that progresses to one or more extrahepatic organ failures, including the brain, kidneys, heart, and/or lungs. This cascade of organ failure can lead to death. It can also trigger other diseases like, for example, the development of a neuropsychiatric conditions called hepatic encephalopathy or HE. ACLF is associated with 23%-74% mortality at 28 days, depending on the number of organ failure. There are very few therapeutic options that exist, and currently no product has been approved for the management of ACLF. In the US only, there were 137,000 patients hospitalized with ACLF last year. Unsurprisingly, the incidence is growing dramatically as it is fueled by the increasing prevalence of diabetes, obesity, NASH, as well as alcohol or drug-induced liver injury. There is limited available market research, but estimates for the market potential are approximately $4 billion a year in the US and about EUR 2 billion in Europe. GENFIT has significantly stepped up its effort in this field, and we are generating what we believe is very promising data about NTZ. We also started to research the field and study the literature, and we noted that there were very few companies with active programs. Versantis stood out for us when we did that literature search because it was one of the pioneers in ACLF, and they had developed a very unique approach that we felt was supported by a strong scientific rationale. We also saw it as a potentially very complementary approach to NTZ. At this stage, let's describe the different programs at Versantis. The main asset in Versantis pipeline is called VS-01. It relies on a very innovative approach based on a proprietary scavenging liposomes technology. What VS-01 does is clearing toxic metabolites, in particular ammonia, from the body by extracting them from the blood into the abdominal cavity, where they are captured by the liposomes, which are then drained from the body. It's not an oral molecule, but a product that is administered in hospital using standard hospital equipment like a catheter, which we believe can easily be incorporated into standard of care for these patients. VS-01 has the potential to be the first drug to use the intraperitoneal route to simultaneously support the liver, kidney, and brain, i.e., the organs that most often fail in cirrhotic ACLF patient. It's a first-in-class drug that uses a new and unique mechanism of action for the potential treatment of ACLF. With recruitment of the first patient into the phase 2 expected very soon, VS-01 in ACLF is Versantis most advanced program. VS-01 is also positioned in a second program in urea cycle disorder or UCD, which is a rare pediatric indication characterized by deficiency of one of six enzymes involved in the urea cycle. This deficiency leads to high level of neurotoxic ammonia in the blood, which is why we also talk about hyperammonemia. UCD occurs in one out of 10,000 births. It's characterized by a very low five-year survival at only 25%. It causes severe brain injuries. It is believed that UCD represents 70% of hyperammonemic crisis cases, and based on these estimates, the market potential is expected to be above $1 billion in U.S. and Europe combined. The potential of VS-01 has been recognized by both the FDA and the EMA. The product has indeed been granted Orphan Drug Designation or ODD by the FDA in ACLF and with a Rare Pediatric Disease Designation, RPDD, for the acute treatment of UCD. In addition, the EMA also granted VS-01 with Orphan Drug Designation in acute liver failure. Versantis has also another asset, which is a small oral molecule called VS-02. It is being developed for the management of HE, which I mentioned earlier. Again, this is a nervous system disorder brought on by severe liver disease, and it also represents a fast-growing condition. And because some mild cases of hepatic encephalopathy may go undiagnosed, it is a bit difficult to determine the true frequency in the general population. However, according to rarediseases.org, hepatic encephalopathy is most often associated with cirrhosis, which is estimated to affect 5.5 million people in the United States. Approximately 70% of these individuals with cirrhosis may develop symptoms of hepatic encephalopathy. Patients with HE account for approximately 110,000 hospitalizations yearly in the United States. While the number in EU are not readily available, it's likely that these predictions are going to be similar. In this context, HE is expected to represent a $2 billion market opportunity. VS-02 will be developed as a unique colon-active formulation designed to minimize systemic absorption and act where ammonia is primarily produced while reducing glutamine levels in the brain. Versantis is also working on TS-01. TS-01 is a unique point-of-care diagnostic device in prototype development for the at-home measurement of ammonia in blood, the primary cause of HE. It has the potential to provide HE patients with an instrument to manage tighter control of their blood ammonia levels and provide a means to better manage companion therapeutic treatments for their condition. We believe that there are significant synergies between the two companies. Indeed, the portfolio of products and indications is complementary. After the acquisition, GENFIT will have 6 ongoing programs in 5 rare liver diseases, PBC, CCA, ACLF, UCD, and HE. These programs will range from preclinical to late-stage phase 3. In ACLF, NTZ and VS-01 have different mechanism of action, so they could potentially be combined, thus opening interesting research perspectives. Next year we could have 2 active phase 2 studies in ACLF, which will make us a global leader in this field. Beyond the programs, the company's respective strengths are also complementary. As mentioned earlier, Versantis was a pioneer in ACLF, and they were among the first to study the development of a drug for this condition, and they have developed a strong medical and scientific experience. They also have developed a promising technology that they have taken from academic prototype to the start of phase 2. GENFIT's experience, as we discussed earlier, lies in the capabilities we have developed in liver related research, target identification, pre-clinical activities, including phenotypic screening or preclinical POC with the development of several models, organoids as well. We also have a deep expertise in development, including working with KOL, study design, successful execution of large complex trials up to data readout and stat analysis. We also have worked closely with regulatory authorities in both the U.S. and Europe, as well as with all the relevant patient association. This is why we think that we will be able to combine, by combining those two companies, to maximize the potential of Versantis program, accelerate them, and increase their probability of success. With these synergies on both pipeline and expertise, we are ready to start generating an exciting series of clinical data that will fuel our news flow in the near future. Now that we have spent some time discussing the strategic rationale and described the impact of this acquisition for GENFIT in terms of pipeline and expertise, let me walk you through some financial consideration. Let's start with the terms of the deal. First of all, let me remind you that the exclusive agreement we announced today is an engagement to acquire all the share capital and voting rights of Versantis. It's an acquisition, and that transaction should technically be completed in the course of the fourth quarter of this year, 2022. The deal terms include a payment of CHF 40 million, as well as potential additional payments that are contingent on successful clinical and regulatory milestones. These milestones can go up to CHF 65 million upon positive phase 2 results with VS01 and VS02, as well as regulatory approval of VS01. In addition, and should we be successful with VS01 in UCD, Versantis is eligible to receive one-third of the net proceeds resulting from the potential sale of a pediatric review voucher by GENFIT to a third party, or one-third of the fair market value of this voucher if GENFIT opt to apply it to one of its own programs. This acquisition will be financed with our current cash and cash equivalents. Our cash burn projections that include the funding of the clinical and pre-clinical developments for all those programs, these new programs, as well as the funding of our current programs. That also includes some expected payments from our partnership give us roughly a two-year cash runway. You will have more granularity and other financial details in our upcoming half year financial report, which will be published on September twenty-eighth. About 10 days from now. Before I open the floor to your questions, I would like to thank the GENFIT team that has worked really hard on the due diligence process over the last few months. I also would want to welcome the Versantis team into GENFIT. As a matter of fact, two of its co-founders, Vincent and Meriam, are here with us today and will join the Q&A. With that, operator, let's open it to Q&A. Thank you. If you'd like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speaker phone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press star one to ask a question. We'll pause for just a moment to allow everyone an opportunity to signal for questions. We'll go first to Thomas Smith with SVB Securities. Hey guys. Good morning. Congrats on the deal and, thanks for taking the questions. Just on, VS01, can you just give a little bit more detail on the existing phase one data and, what's been presented previously in decompensated cirrhotic patients? Then, can you provide a bit more detail on the plans for the phase two study and, what data you'd need to generate to tap into the accelerated regulatory pathway here? Is it your expectation that you could advance, based on the phase two data, or is it your expectation you'd need an additional study after the phase two? Thanks. All right. Thank you, Thomas. I'm going to give the floor to Meriam to answer your question. Meriam is one of the co-founder of Versantis. Meriam, floor is yours. Thank you, Tom, for the question. I will answer your first question with regards to the data that we gathered in the first in-human trial with the VS01. Of course, the primary endpoint of that study was to assess efficacy, and we were able to show that after single and multiple doses of VS01, the drug was safe and well-tolerated. In terms of efficacy, we had some very encouraging primary results. We were able to show an improvement in the overall disease severity based on the Child-Pugh score and MELD score in the majority of our patients. We were able to show a clinical improvement in hepatic encephalopathy, and we all know that hepatic encephalopathy is an independent predictor of mortality in ACLF patients. This was done through several psychometric tests for hepatic encephalopathy. We were able to show that VS01 can significantly improve or increase the clearance of ammonia in these patients, as well as the reduction of several lab parameters which are relevant in ACLF, for example, bilirubin and creatinine. Another important aspect, and this is also related to the second part of your question. We presented at the AASLD last year one poster that summarized the data that I just described. At the ILC this year, the EASL conference in 2022, we presented two abstracts related to the metabolomic result that we observed in the first-in-human study, which shown that VS01 could decrease some of the markers that are related to organ failure as well as bacterial infection. All these data are promising for our POC at the upcoming POC study. Okay, great. You want to add another question, Tom? Yeah, actually, go ahead. Yeah, if you could just speak a little bit more toward the plans for the phase 2 study and I guess expectations for what you would need to show to tap into an accelerated regulatory pathway. Yeah, sure. The phase 2 study, it's a POC study. It's gonna be an open label, randomized, controlled, multi-center proof of concept study. The primary endpoint will be to assess efficacy, as well as safety and tolerability of VS01 on top of standard of care, compared to a standard of care alone group. In terms of our primary endpoint, we will use the CLIF-C ACLF score, which is known to correlate with the 28-day mortality in these patients. We believe that this endpoint will inform us on the design of the phase 2 B study. Right now, we think that a phase 2B study will most likely be required before we can get or ask for the marketing authorization of VS-01. Okay, great. That's helpful. Yeah, thanks guys for taking the questions and congrats on the deal. Thank you. We will go next to Suzanne van Voorthuizen with Kempen & Co. Hi. Good afternoon. This is Suzanne van Voorthuizen. Congrats with the deal. I was wondering, regarding VS01, can you elaborate a bit more on the mechanism of action, and the proprietary or novel about the liposome technology? How is it specific for the toxic metabolites in ACLF? After that, I have a follow-up question. Okay. Thanks, Suzanne. I'll ask Vincent to answer this question. Vincent is the other co-founder of Versantis. Sure. Thank you. Thanks, Suzanne, for the question. Yeah, as Pascal mentioned just before, VS01 is the scavenging liposomes technology. This is a fluid solution that we inject in the abdominal cavity, just to give you an idea. This patient with acute on chronic liver failure, they present to the hospital with ascites, right? They do have a catheter which is there as a standard of care to withdraw the ascites, so to drain the ascites out, so that there is an entry route to the abdominal cavity for our product. We'll use this empty route to inject VS01. It's approximately 1-3 liters per patient that we inject, and the therapy lasts approximately 3 hours. We repeat that during the first week after the start of the decompensation of acute on chronic liver failure. That is just to give you a little bit of understanding on how it will be done in the clinic, but now to your specific question on the mechanism of action. In our fluid, we have these engineered and specific liposomes. These liposomes contain a pH gradient. That mean that inside the liposomes, we have an acidic medium. Outside the liposome, it is physiologic pH. These liposomes are able to scavenge the toxin that the liver, due to the disease, is no longer able to process, right? These toxin will diffuse out of the blood circulation into the abdominal cavity, in the fluid that contains the liposomes, and then be captured by the liposomes. They are either captured inside, so they are captured in the lumen of these liposomes, if you will, in the core of these liposomes and concentrated there. For the toxins which are more lipophilic, such as many of the inflammation mediators, they are captured within the phospholipid bilayers of these liposomes, right? We have a complete mechanism of action, which is really able to work on several fronts at the same time, on several toxins at the same time, to really be able to clear the blood out of these toxins, Which are deleterious for the patient and which are implicated in hepatic encephalopathy, in the inflammatory process, and in the overall decompensation of the disease. After three hours, as Pascal mentioned before, we just drain the liquid out by the same catheter that we use to drain the ascites prior to the injection of the product. Got it. That's very helpful. Thank you. Just a different question. The press release, you also mentioned, a pre-IND meeting is planned for NTZ, on the back of encouraging phase 1 data. Can you give some color on what that data is and when we should expect the details to be released to the public? We're still working on this, and it will be released probably at AASLD in the late-breaker session. We're still waiting for the feedback from the organizer, but we hope to do it at the late-breaker session at AASLD. Got it. Got it clear. Maybe just a final question from my side. You have still some cash left, but also now quite some plans to execute on. I was wondering, should we be expecting some more BD activity from here or not so much? Thank you. Thanks, Suzanne. Obviously we're always open to opportunities. That being said, after this acquisition, although we do have cash, we also have our hands full in terms of program. As you know, I mean, it's a lot of clinical programs to manage simultaneously. We also have quite a bit of more preclinical work to do, most notably on the VS-02. Don't expect anything of a similar magnitude for sure. All right. Thank you. We'll go next to Arsène Guekam with Kepler Cheuvreux. Hello, gentlemen. Thank you. Do you hear me? Yes. Yeah. Okay. Sorry. Thank you for taking my question too. If I may, what kind of data really convince you to make this deal? Because in fact, in phase 2, the deal, sorry. The drug is currently in phase 1, phase 2 already. And you have only, let's say, safety data and small first feeling of efficacy data. I would like to know what the threshold was for deciding to make this kind of deal. And the second one is more about the phase 2 of VS-01. What will be the size in terms of patients and the duration that you could expect for this phase 2? Thank you. Yes. Hi, Arsène. Thank you. First of all, I would say the decision to make the deal, although VS-01 was important in the deal, it was not the only thing. First of all, on VS-01, we felt pretty strongly about what we saw. First of all, the approach. We felt the approach was both simple and elegant in the sense that it was a very different approach to ACLF, and one that at least theoretically made a lot of scientific sense. We also felt that because of our approach, there were reason to believe that, for example, from a safety standpoint, you should have less issue as it's not like a, it's a normal drug where you introduce a drug and can expect interaction with the entire body. Here, it's something that goes in and comes out. Conceptually, it was also interesting. The data we saw through the due diligence continued to convince us that we had an approach that was potentially a winner. For the deal itself, it was also about looking at the entire portfolio of product and how it fit really well with our strategy to concentrate on rare liver diseases. Here, everything is about rare liver disease. All of it is about disease stage where there is a high medical need, no or very little existing therapeutic option. The fit was just perfect. Looking at the team, we also felt that the team will complement quite strongly our own team and that we would benefit from this acquisition more than just on the existing program, but also on our current program and that what we're doing could benefit from the knowledge of Versantis. All in all, it just felt that it was a deal that made a lot of sense for us. Regarding your second question, I let Meriam- I can take that. Okay. I let Meriam expand on it. Right. For the number of patients that we have planned in this POC study, it's 60 patients in total, and the duration is about 2 years. Duration of clinical conduct. Okay. We'll go next to Ed Arce with H.C. Wainwright. Hello, everyone. This is Thomas. I'm asking a couple of questions for Ed. Congratulations on this deal. Perhaps first question from us. From a mechanistic standpoint, is there any possible benefits to combine VS01 and NTZ for ACLF? Dean, are you on the line? Yes, thank you, Thomas, for the question and very pertinent question. As we had discussed in the past, you know, ACLF is quite a complex and heterogeneous disease. Really the beauty of our transaction and collaboration now moving forward as one single team with the technology coming from Versantis is that really it's really complementary. As Vincent had explained, you know, patients who undergo paracentesis will be using this technology really with the liposomes to remove toxins, including ammonia related to ACLF. You realize with this approach of paracentesis, I think it really provides an opportunity to combine with different approaches, not only with NTZ, but I think with any other technology. What's important, I think, is that the mechanism of action needs to be complementary, and I think then the possibility of combinations do present itself. Having said that, right now we feel that the VS01 technology as well as the NTZ technology by themselves should be able to provide clinical benefit to the ACLF patients. To your point, you know, when you think about ACLF, the possibility of combinations is always very important. Okay. Got it. Perhaps one follow-up for VS02. Will you classify that as an ammonia scavenger? And if so, how is it differentiated from other currently available options? Thank you very much. Yeah. This is Vincent Forster. VS02 is not per se an ammonia scavenger. It is a colon-active small molecule drug, right? It will act in the colon to reduce the production of ammonia. It's a urease inhibitor and one of the main source of ammonia in your body is via the hydrolysis of urea by this urease that you have in the colon. By blocking this process, we do reduce the ammonia in the colon and therefore do reduce the absorption of ammonia in the body. Understood. Thank you again for taking our questions and congratulations again on the deal. Thank you. At this time, there are no further questions. I'll turn the call back to the speakers for any additional or closing remarks. All right. Thank you, and thank you all for your questions. We realize there is a lot of new things to cover, and this is why we have decided to organize a pipeline day in October to provide greater insight into our programs, into the unmet medical needs they seek to address, and also how you should be thinking about market potential and development timelines. We will have two dates for this pipeline day, the first in Paris and the second one in New York City. Stay tuned for those. Now in conclusion, I'd like to summarize the main takeaways from this call. Number one, this deal marks the continuation of the implementation of a corporate strategy that was presented in the fall of 2020. It enables us to build a broad, diversified pipeline of promising programs targeting rare liver diseases characterized by high unmet medical need. Number two, with this deal, GENFIT strengthens its leadership in ACLF. It expands and diversify its pipeline and creates synergies that will enable us to accelerate the development of potential therapeutic solutions for patients that have no or few alternatives. Number three, with six different programs, a program entering phase 2 as early as the last quarter of this year and two other phase 2 studies slated for next year, we will be in a situation to provide a steady stream of clinically meaningful data in the months to come. Thank you for your attention, and have a great rest of the week. This concludes today's conference. We thank you for your participation.