Inventiva S.A. Q4 FY2021 Earnings Call

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 speakers’ presentation, there will be a question-and-answer session. Right now, I turn the conference over to your first speaker today, Frédéric Cren. Please go ahead.

Thank you and welcome everybody to the full year financial results presentation. As traditionally, I will share the floor with Pierre, our CSO, who will go over lanifibranor; Michael, our CMO, will also present the clinical studies of 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. So before we go into the details of the clinical update, I just would like to provide some key highlights of 2021, which I think has been, when you look at everything that has been achieved, quite successful. If we start with lanifibranor, we had committed to start the NATiV3 Phase III pivotal study, which we did, and on top of that, we also announced the design of the LEGEND study, our combination study between lanifibranor and SGLT2 inhibitor empagliflozin. This morning, you’ve seen that we’ve received positive feedback from FDA and the IND application has been accepted by the diabetes division. The interaction with the FDA, I would say, overall, during the year has been very positive. My highlights are the fact that the drug which we secured for patients with F2-F3 has been extended by the FDA to cover patients with compensated cirrhosis. We’re also extremely pleased by the confirmation, the feedback we got from the FDA concerning the tox package, which the FDA considers adequate and complete to file a New Drug Application in NASH. This is extremely positive, because it means that we tick another box on the way to commercializing lanifibranor. We also continue to prepare and complete our package for filing and we positively concluded a QT/QTc study where lanifibranor demonstrated no impact on cardiac electrical activity. Lastly, as you all know, we had this fantastic publication by the New England Journal of Medicine of the study of the Phase IIb NATiV3 study. So, that’s the highlight for lanifibranor but then I would say 2021 for us was the year of cedirogant. We completed the Phase Ib and, especially, we are very proud and excited to see AbbVie moving forward with this trial, confirming that they’ve seen Humira-like efficacy and they believe that cedirogant could be an efficacious drug in psoriasis. Their decision to move to Phase IIb because the data from Phase Ib were available in April and I think in November, the Phase IIb started, so that’s quite a fantastic accomplishment by the AbbVie clinical team. And that, of course, has a direct financial translation, because it triggered the 4 million milestone when the first patient in the Phase IIb was included in the study. Odiparcil, we continue preparing for a meeting with the FDA. The objective is to validate with the FDA the design of a pivotal trial, which we think is key in finding a new home for Odiparcil. Other less visible highlights, we opened Inventiva Inc. in the US where we host an important and sizable cleanup team to follow our NATiV3 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 financial side, Jean will cover that in detail, but we’re very pleased to have activated 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 and the cash runway, which runs through Q1 ‘23. This is my quick introduction; now I’ll give the floor to Pierre, who will give you a brief update on lanifibranor.

Okay, thank you, Frédéric. So we’re now moving on Page 10. As you know, lanifibranor is a pan-PPAR agonist in clinical development Phase III for the indication, treatment of NASH and improvement in liver fibrosis. It has an unprecedented structure and pharmacological profile. It’s a pan-PPAR agonist with moderate and well-balanced activity across the three PPAR isoforms. It’s not a thiazolidinedione and it’s not a fibrate. You’re very much aware of the number of pre-clinical investigations we have performed, showing that most, if not all, of the pathological features of NASH can be addressed by lanifibranor through the activation of several PPAR isoforms, for example, delta and gamma activation. This is really important and leads to the strong anti-fibrosis activity of the compound, whereas the three isoforms are involved in inhibition of inflammation and ballooning. The potential of lanifibranor to address most, if not all, pathological features in NASH has been validated in the NATiV3 Phase IIb trial in non-psoriatic NASH patients, and the results of this study actually supported breakthrough therapy designation by the FDA, which came on top of the Fast Track designation already granted for lanifibranor. From a safety point of view, as you know, the non-clinical tox package, which included long-term studies of up to two years, showed that lanifibranor had a good safety profile, and the FDA confirmed that this tox package is complete and acceptable to support the filing of an NDA. Lanifibranor in the clinic has also favorable reliability profile evidenced as of today in close to 500 patients or healthy volunteers. Importantly this year, we have completed a thorough QT/QTc study, a standard component of all clinical development programs for any new therapeutic agent in support of NDA. This kind of study is also of interest in the context of the targeted population, as QTc interval prolongation is common in patients with liver cirrhosis. Therefore, the design we used was the one recommended by the FDA, intended to confidently identify drugs that may cause QT prolongation. In this study, repeated daily administration of lanifibranor at doses up to twofold higher than the maximum therapeutic dose had no effect on the QT interval. This study meets the FDA requirements and therefore confirms once more the safety of lanifibranor on cardiac activity previously observed in our Phase II studies. Moving to the next slide, following the successful outcome of the NATiV3 Phase IIb trial with lanifibranor in NASH, we have agreed on the Phase III study design with the FDA and EMA, and this study is now initiated. To complete the clinical development plan of lanifibranor in NASH, besides the study in collaboration with Professor Cusi, evaluating the effect of lanifibranor on liver insulin resistance, we have also initiated another profiling study in NASH patients, which is going to evaluate the potential of lanifibranor to be used in combination with empagliflozin in NASH patients with type 2 diabetes. The key dates related to these three studies are as follows: We expect results from Part 1 of our Phase III study in the second semester of 2024. The results of the study on liver insulin resistance in NAFLD patients with type 2 diabetes will come in the second semester of this year. The results from the combination of lanifibranor plus empagliflozin in NASH patients with type 2 diabetes will come in the second semester of 2023. To recap on the design of the Phase III, in terms of inclusion criteria, we are fully aligned with the patient population that has been included in the NATiV3 Phase IIb trial. The focus is more on F2 and F3 patients than in the NATiV3 Phase IIb. Patients will be included in the study when showing an activity score, meaning a combined score of ballooning and inflammation that is equal or superior to three out of four, with a fibrosis score of F2 and F3. The patient population will be stratified on type 2 diabetes F2-F3 status. It will have three arms, evaluating two doses of lanifibranor, 800 and 1200 milligrams that were investigated in the Phase IIb trial. The statistical powering is 90%, and the central biopsy reading process has been agreed with regulatory authorities, involving review done by three pathologists. The endpoints for the first part will last 72 weeks and will include 900 patients. The primary endpoint is a composite endpoint of NASH resolution and no worsening of fibrosis, meaning that patients would be qualified responders if they show both NASH resolution and improvement by one stage of the fibrosis score. In the NATiV3 Phase IIb study, the placebo showed 7%, while the number of responders in the low dose were 24%, for the high dose 33%, demonstrating three to four times more responders in the treated arms relative to placebo. A secondary endpoint will include NASH resolution and no worsening of fibrosis, improvement of fibrosis, and oversight of NASH. Other endpoints will encompass glycemic control, improvement in renal function, and reduction of cardiovascular risk, among others. Where do we stand today? The study is conducted with us by ICON and two clinical research networks specialized in NASH, Summit in the US and AES in Europe. Currently, we have 350 sites qualified, and the study has been approved in 11 out of 25 countries. The regulatory review is ongoing in the 14 remaining countries. We have 121 sites activated, including 77 in the US and 44 in Europe. Due to the current circumstances in Ukraine, all clinical sites in Ukraine and Russia have been put on hold, and we are working on a mitigation plan with ICON to activate additional sites in other countries to compensate for the missing recruitment in those two countries. Additionally, we are actively working on establishing an efficient and secure drug substance and drug product commercial supply chain worldwide moving forward. For the drug substance, we will have two major CDMOs involved, both FDA approved with industrial capacities ensuring the supply in the US, Europe, and the rest of the world. A pharmaceutical development plan to support the commercial supply has been defined with them, for both drug substance and drug products. I would like to hand over to Michael, who will go through the presentation of our study in NAFLD patients with NASH, in collaboration with Professor Cusi. Please, Michael, go ahead.

Thank you, Pierre. I will cover two studies that further support and profile lanifibranor regarding its efficacy in patients with NASH and also patients with type 2 diabetes. The first study on slide number 19 is a study in patients who have NASH and NAFLD with type 2 diabetes. This is designed to further understand the mechanisms through which lanifibranor works as a pan-PPAR agonist on various aspects of these metabolic diseases. The primary efficacy endpoint is a reduction in intrahepatic triglyceride accumulation. Importantly, we will delve deeply into how this reduction relates to changes in adipose tissue and insulin resistance in the main organs: fat tissue, liver, and muscle, which are all affected by metabolic diseases. Additionally, we will assess how the cardiometabolic risk profile, or indicators of cardio metabolic health in patients with NAFLD and type 2 diabetes, are favorably influenced by lanifibranor. Non-alcoholic fatty liver disease, NASH, and type 2 diabetes share an underlying disease biology, with approximately 70% of patients experiencing some overlap. As these diseases progress, they become more likely to co-occur, complicating diabetes management as NASH worsens, and making access to medications more crucial for such patients. The coexistence of these conditions is closely linked to the severity of insulin resistance across multiple organs, ultimately leading to increased cardiovascular risk associated with atherogenic dyslipidemia, characterized by elevated triglycerides, low levels of beneficial HDL cholesterol, and smaller denser LDL particles. Slide number 20 covers a study being conducted with Dr. Cusi in Florida, the investigator and sponsor. It is a small study aimed at further detailing the mechanism of action of lanifibranor, involving a total of 34 patients with type 2 diabetes. They must be well controlled within certain limits, specifically ensuring their HbA1c does not exceed 9.5%. They should not be on insulin or have received pioglitazone in the past year and must have NAFLD diagnosed non-invasively for this study. Participants are required to have at least 10% hepatic fat as determined by MRS and maintain stable weight, defined as no significant increase or decrease of body fat. This study will also employ state-of-the-art investigations, providing a comprehensive view of the metabolic and beneficial effects lanifibranor has in these patients. We will utilize ultrasound-based imaging and FibroScan for evaluating liver fat and fibrosis, along with MRI for measuring fat PDFF and elastography for assessing fibrosis. The study also features advanced corrected T1 MRI mapping, which will give insights into liver inflammation and fibrosis. Various other tests will determine the degree of insulin sensitivity through euglycemic clamps and insulin injections to measure initial effects. The main imaging and metabolic results will focus on intrahepatic triglycerides, MRI-based fibrosis assessment, and insulin sensitivity metrics while including liver fibrosis markers. Slide 21 reiterates that Dr. Cusi is the principal investigator in this ongoing study, with 34 patients randomized to receive either a placebo or 800 milligrams of lanifibranor daily. Additionally, 10 healthy non-obese individuals will serve as reference subjects for these evaluations. The primary efficacy endpoint centers on monitoring changes in intrahepatic triglycerides at the end of treatment after six months, alongside a broad panel of secondary endpoints focusing on other metabolic markers associated with NAFLD and type 2 diabetes, insulin resistance, and hepatic fibrosis. Our study is actively recruiting, and we anticipate completion by the year's end. Enrollment experienced delays due to COVID-19 but has picked up recently. Slide 22 introduces another proof of concept study evaluating combination treatments. We see significant merit in combining lanifibranor with empagliflozin, an SGLT2 inhibitor, particularly for patients grappling with NASH and type 2 diabetes. Slide 23 contextualizes how a large number of patients with type 2 diabetes also exhibit additional metabolic syndrome complications like obesity, dyslipidemia, hypertension, and cardiovascular risk factors, all linked to underlying insulin resistance. The increasing prevalence of type 2 diabetes globally underscores the need for effective combination therapies targeting these upstream metabolic pathways. Slide 24 explains why we anticipate that lanifibranor and empagliflozin represent a promising combination. Lanifibranor's unique profile exploits the PPAR transcription factors' capabilities across multiple organs, leading to benefits for lipid and carbohydrate metabolism and an anti-inflammatory effect. In contrast, SGLT2 inhibitors such as empagliflozin have upstream effects, reducing glucose reabsorption in the kidneys and decreasing inflammation. This makes them ideal complements to one another. Slide 25 illustrates the LEGEND study, which we believe is highly promising regarding the efficacy of the therapeutic combination. The focus here will also be on fat distribution and the biology of adipose tissue. Notably, some patients treated with lanifibranor may experience weight gain that is distinct from typical patterns associated with poor diet or inactivity; rather, it is metabolically healthy gain, which we want to mitigate for patients who may have concerns. Combining it with empagliflozin, known for its weight-reducing effects, could balance out any weight changes attributed to lanifibranor. Furthermore, we will utilize MRI to assess the treatment's impact on liver fat, inflammation, and fibrosis, while also observing body fat distribution. The primary efficacy endpoint will be based on HbA1c, crucial for diabetes studies, and we possess sufficient prior information regarding lanifibranor's impact. In conclusion, significant enthusiasm surrounds our ongoing combination studies and their anticipated outcomes. Now, let’s hand it back to Pierre for an update on cedirogant.

Thank you, Michael. Let’s switch gears to cedirogant. Looking at page 29, cedirogant is an oral, once-daily administered ROR gamma inverse agonist currently being investigated in the Phase IIb clinical trial for treating moderate to severe psoriasis. This decision stems from a successful Phase Ib study in patients with moderate to severe psoriasis. Cedirogant was developed jointly by Inventiva and AbbVie, and its royalties significantly have the potential to become an important revenue source for Inventiva. The success of anti-IL17 and anti-IL23 biologics in psoriasis treatment validates the IL23-IL17 pathway as an important therapeutic target, thus creating a significant market opportunity for a robust treatment focused on ROR gamma in psoriasis and possibly other immunological indications where IL-17 plays a role. Moving to the next slide, the relevance of the IL23-IL17 pathways in psoriasis is primarily driven by IL-17 secreted from Th17 cells, which regulate keratinocyte proliferation and differentiation, thereby inducing chemokine secretion that brings in immune cells, such as neutrophils and dendritic cells. ROR gamma, a nuclear receptor, controls Th17 cell differentiation and effector function, regulating IL-17A and IL-17F transcription. Blocking ROR gamma can inhibit Th17 differentiation and IL-17 production. On the following slide, we present the results of one of our publications exemplifying our early ROR gamma inverse agonist, A-9758, discovered with AbbVie. In in vivo models of psoriasis induced by IL-23, A-9758 was effective in reducing inflammation and epidermal thickening while suppressing the gene signature associated with IL-23 exposure, demonstrating substantial therapeutic potential. Additionally, we understand that clinical studies show IL-23 biologics are less effective against rheumatoid arthritis, while those targeting IL-17 show promise. In rheumatoid arthritis models, A-9758 demonstrated a significant reduction in post-swelling, outperforming anti-TNF therapies. Next slide highlights the substantial commercial opportunity for oral efficacy in psoriasis. As you know, psoriasis affects 2-4% of the population in Western countries, with a $20 billion global market in 2020. Today, the market is dominated by injectable anti-IL23, IL-17, and TNF alpha biologics, making up over 80% of the sales. Otezla, an oral PDE4 inhibitor, generated $2.2 billion in sales and was acquired by Amgen for $13.4 billion in 2019, despite a comparatively inferior efficacy and tolerability profile. Several orally available candidates have been investigated as potential treatments for psoriasis. Phase III trials of TYK2 inhibitors recently reported promising PASI-75 responses but have been associated with increased risk of adverse events. Currently, the Phase IIB trial of cedirogant is evaluating safety and efficacy in 200 patients with moderate to severe psoriasis. The completion date is estimated for March 2023, and promising activity was previously noted in our Phase Ib study by Michael Severino, AbbVie’s Vice Chairman and President. Conclusively, the ROR gamma competitive landscape remains relatively limited with few compounds, including cedirogant in Phase II; others, such as Bevurogant and AUR101, are under development with unknown standing. With that, I would like to invite Jean for the financial results.

Good afternoon and good morning to everyone. I will review our financial performance over two slides. Beginning with the shareholder base, we see that it remains stable and has even been consolidated thanks to the ATM of $32 million, thus encompassing existing shareholders while also welcoming newcomers into the shareholder base. Our market cap currently stands at $450 million. Performance in the market was relatively positive in 2021, though we, like all sectors, particularly biotechnology, faced challenges stemming from the Ukrainian crisis. In terms of cash, it's straightforward to remember the figures; we’re nearing $100 million, considering the 4 million Euros milestone received in January from AbbVie. Our estimate for cash runway is one year from now. The figures regarding financial metrics are relatively easy to interpret. They are in line with what was discussed for the H1 financial performance. Revenues are composed of the milestone from AbbVie at 4.2 million. Importantly, our R&D expenses have doubled in ’21 compared to ’20, reaching 48.4 million. General and administrative expenses increased by 31%, primarily due to investments made for clinical development activities and our assets, particularly focusing on lanifibranor. G&A expenses increased as expected; this was the first full year for Inventiva with a dual listing status. Cash-wise, we ended the year at 95.4 million, factoring in the 4 million received in January. Therefore, we have about one year of cash runway to operate. The way we structured this aligns with operational expenses, with net operating cash flow used in ’21 amounting to close to 50 million compared to 30 million last year. Cash investing activities and financing activities were mitigated by the ATM that enabled us to raise gross proceeds of $32 million.

Before we move to Q&A, I’ll highlight the anticipated key milestones. I’ll focus here only on clinical readouts. We will have top-line results from the study in patients with type 2 diabetes in the second half of this year. Early in ‘23, we expect the cedirogant Phase IIb results. We anticipate another significant clinical readout regarding the combination study of lanifibranor plus empagliflozin, and we are also eagerly expecting very important top-line results from the NATiV3 Phase III in the second half of ‘24. So, this wraps up the highlights for 2021. We are ready to take your questions, and the operator will provide detailed instructions to follow.

Your first question comes from Lucy Codrington from Jefferies. Please go ahead.

Hi, there. Thanks for taking my questions. Just a few please. Firstly, on the cash runway, Jean, can I confirm, does that include the costs for the LEGEND trial? And I’m assuming it doesn’t include any other potential milestones from AbbVie or other sources? Secondly, regarding the Phase III recruitment, is that progressing as planned? I noticed on the slides that Russia and Ukraine account for about 22 sites, which is about half of the EU sites currently active. How many of those 22 sites were active, and what drives your confidence that this won’t lead to a delay in the data? Finally, on the remaining milestones from AbbVie, I believe it was 35 million, and we’ve had two thus far, so, am I correct in thinking 27.5 million Euros is left for those milestones? Thank you.

Thank you, Lucy. For the cash runway, perhaps Jean you want to address that?

To your question regarding LEGEND, the budget certainly considers this additional study. There are no milestones planned this year from AbbVie, given the development plan we have in place. We may hope for additional milestones in ‘23 if we receive positive news, as per the contract. Your second question, regarding remaining milestones from AbbVie, I don't have that at hand, but we can get back to you on that.

We can follow up with you. It will specify in the filing, in the URD and the 20-F that will be filed next Friday. If it’s not stated in this document, we think it will be documented, and you can call back with us. Regarding the Ukrainian and Russian sites, we had planned to open 10 sites in Ukraine; three had started screening patients, while the other seven were not yet operational. Given the situation, all activities have been paused there, with little hope that activity will resume. The remaining 12 sites are in Russia, which has not yet opened. Regulatory filings continue as normal, so I would say there is no impact on the current screening activities in Russia. Overall, we need to recover 22 sites. Through various presentations, you may know that we've increased targeted sites to 350 or more; initially, we aimed for only 250 but have raised that number. Recently, we contracted with Summit, which specializes in recruitment in NASH, a very efficient organization, primarily with sites in the US but also in Europe, contributing to mitigate any impact from the situation. Now, we are working with ICON to secure additional sites.

Thank you very much.

Thank you. The next question is from Jeroen Van den Bossche from KBC Securities. Please proceed.

Thank you, and congratulations on yet another great year, especially with lanifibranor. Just a follow-up on that. Looking at empagliflozin, is the data currently based only on existing data, or is there additional preclinical data being used to inform the LEGEND trial? Also, how do you envision the future of lanifibranor, cedirogant, and Odiparcil? Are you open to collaborations, or are you focused on bringing these to market yourselves?

Thank you, Jeroen. Perhaps for the empagliflozin rationale and data available, Pierre or Michael, would you like to take this question?

I can address that. Regarding the rationale for empagliflozin, the data does stem from a number of clinical trials where, as Michael mentioned, empagliflozin and other SGLT2 inhibitors have been administered alongside pioglitazone, demonstrating a decrease in body weight.

It is essential to recognize that the mechanistic actions of these compounds are well understood. Empagliflozin is approved, and many patients with metabolic immune diseases are prescribed multiple medications including this combination. As such, it is not unusual; the aim is to evaluate the combination's effects on NASH and type 2 diabetes while also considering patient weight management. However, we don’t require additional nonclinical data to support this rationale.

So to clarify, you believe there is enough circumstantial data to move forward without requiring detailed data on the combination?

Indeed, empagliflozin is already approved. Patients typically take multiple medications, including statins, so the use of combinations is common. We are studying it to demonstrate added efficacy in the context of NASH and type 2 diabetes alongside weight management, where we are not depending on preclinical data.

For the future, would you be open to self-marketing or would collaborations remain an option?

Currently, we are focused on moving forward with the partnerships that align with our strategies.

In terms of lanifibranor's potential, we view it as a significant opportunity for big pharmaceutical companies. NASH represents a vast market, necessitating the experience and capabilities that large pharma offers. Thus, our goal is to find a partner. Given the asset's value, we want to capture the right moment to partner strategically, either post-Phase III or earlier should a good opportunity arise. As for cedirogant, any developments will be driven by AbbVie, which is responsible for funding and commercialization. Lastly, concerning odiparcil, our strategy remains unchanged. We recognize the limitations in managing both lanifibranor and odiparcil concurrently while focusing on NASH development. It is vital to find a suitable home for odiparcil, which we believe can offer a new treatment option for patients suffering from MPS VI.

Thank you for clarifying.

Thank you. The next question is from Jean-Jacques Le Fur from Bryan, Garnier. Please proceed.

Good afternoon and congrats again for this strong year. I have three questions, if I may. Firstly, regarding the LEGEND trial, could you clarify why you selected the 800-milligram dosage instead of the 1200-milligram variant? I understood that the 800-milligram performed weaker during the NATiV3 trial in terms of efficacy. Secondly, while focusing on lanifibranor, could you provide insights regarding whether you have other programs that may advance in the pipeline over the next few months? Lastly, concerning the envelope around the cash, if you're planning for a year of expenditure, do you anticipate needing approximately 100 million this year, and what drives this considerable increase compared to last year? Is it largely because of the Phase III for lanifibranor?

Thank you. Perhaps Michael can elaborate on the LEGEND trial query.

I have rejoined the call. To give clarity on dosage selection, we chose the 800-milligram dosage because it produces maximum efficacy regarding HbA1c. There is no significant difference between the 800 and 1200 milligrams concerning HbA1c; hence the decision. However, while the 1200 milligram has shown better results concerning histology and fibrosis qualification after six months, given that LEGEND primarily evaluates metabolic immune markers rather than fibrosis, the choice of 800 milligrams was intentional.

Moreover, we’ve identified several lead compounds in our pipeline currently progressing in vivo, particularly those targeting hepatic and renal cancers, due to their promising efficacy observed in vitro across various cancer cell lines. We will continue profiling these compounds in relevant animal models and keep you updated on their development.

As for the cash inquiry, you are correct that expenses could reach approximately 100 million this year. The essential driver behind this increased expenditure from last year is primarily the NATiV3 preparations and the launch of studies alongside a significant uptick in CROs and CDMOs costs as we consolidated our development teams to prepare for Phase III.

Regarding funding plans, we will evaluate the best options when the time comes based on market conditions, possibly considering non-dilutive options along with loans and our ATM.

Thank you for your answers.

The next question is from Seamus Fernandez from Guggenheim Securities. Please proceed.

Hi, this is Ivan Wang on behalf of Seamus. Could you elaborate on the proof observed in the Phase I study, and how that instills confidence moving into the Phase IIb, especially given the competitive landscape? Also, while I understand the limitations on discussing future indications, which ones might fit best for this target? Thank you.

Pierre, would you like to comment?

Certainly. Unfortunately, the Phase Ib data remain unpublished. AbbVie may present these results at an upcoming conference, but we await official data release. Nevertheless, AbbVie made the decision to proceed with the Phase IIb based on convincing data, indicating strong confidence in the product’s therapeutic potential. As for potential indications where this mechanism could be of value, we recognize several immunology indications where IL-17 inhibition is crucial. Examples include axial spondyloarthritis, psoriatic arthritis, and rheumatoid arthritis.

We have no further questions over the phone at this time.

Thank you all for attending; we appreciate the engaging questions and discussions. Our next event is EASL in June, and we look forward to presenting our findings there. We've submitted a new data abstract for acceptance. We hope to facilitate a KOL webcast to cover the data concerning NASH and more at EASL in London. Have a great day everyone.

This concludes the conference for today. Thank you for participating. You may now disconnect.