Earnings Labs

Inventiva S.A. (IVA)

Q4 2020 Earnings Call· Sat, Mar 6, 2021

$5.02

-2.14%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.
Transcript

Operator

Operator

Good afternoon, ladies and gentlemen and thank you for standing by. Welcome to today’s Inventiva’s Full Year 2020 Results Presentation. At this time, all participants are in listen-only mode. [Operator Instructions] I must also advise you meeting is being recorded today on Friday, March 5, 2021. And may I have hand the meeting over to your host today, Frédéric Cren, Chairman, CEO and Co-Founder of Inventiva. Please go ahead, sir. Frédéric Cren: Thank you, operator and welcome everybody. Good morning and good afternoon. And I am very pleased to launch this 2020 financial webcast. As you know, 2020 has been a fantastic year for Inventiva. I will be doing some – with my colleagues some forward-looking statements. So, please look at the regulatory documentation that is available on our website. I will be sharing the floor today with Pierre, our CSO and Co-Founder with me, with Michael Cooreman, our new CMO he has been dialing from the U.S. and with Jean that will give us an overview of the figures. So, let me go immediately into the core of the presentation and just give you some highlights of this fantastic 2020. So, if we start with landing our lead program in NASH, I don’t want to spend too much time detailing the fantastic achievement that has been done in 2020. Pierre will go through the result of NATIVE that led us to obtain breakthrough designation into very positive meetings with both FDA and EMA and Michael will run you through the NATIVE 3 trial that is starting in a few weeks. Nevertheless, we would like to point out a very important view that we got from FDA very recently it’s a couple of days old and that concerns the fact that the FDA has confirmed that the toxicology package is…

Pierre Broqua

Analyst

Yes, thank you, Frédéric. So, as you all know, lanifibranor is the only pan-PPAR agonist in clinical development for the indication and treatment of NASH and improvement of liver fibrosis. You know that it has an unprecedented chemical structure and unprecedented pharmacological profile. It’s pan-PPAR agonist with moderate and well-balanced activity across those 3 PPAR isoforms, not fibrate. Recently, a few months ago, we obtained breakthrough therapy and Fast Track designations that was granted by FDA. Let me turn on to next slide. So, preclinical investigations have shown that most if not all, of the pathological features of NASH can be addressed by lanifibranor through activation of several PPAR isoforms. So, for example, the PPAR delta and gamma activation leads to a strong anti-fibrotic activity. These three isoforms are involved in the inhibition of inflammation and ballooning induced by lanifibranor, while the alpha and gamma isoforms are involved in the reduction of intrahepatic vascular resistance and portal pressure, which was observed in animal models of cirrhosis and data has been published recently. Next slide. So, in non-clinical tox studies with lanifibranor, favorable tolerability profile was observed. This profile differentiated from what was previously reported by single or dual PPAR agonist from different chemical classes. And as mentioned by Frédéric, it’s important to note today that recently FDA confirmed that this non-clinical tox package is complete and acceptable to support the filing of a new drug application. Next slide, please. So, following the successful outcome of the NATIVE Phase 2b trial with lanifibranor in NASH, we have been this last month very busy discussing with the regulatory authorities at the EMA to finalize the Phase 3 design and Michael Cooreman, our CMO will present the details and the key milestones of this study. To complete the clinical development plan of lanifibranor…

Michael Cooreman

Analyst

Thank you, Pierre. So, on slide – next slide to the Phase 3 trial is meant to achieve registration for the indication of NASH with F2-F3 fibrosis. Next slide. This is some large study. It’s a randomized, double-blind, placebo-controlled multi-center, of course, Phase 3 study evaluating the long-term efficacy and safety of lanifibranor in adult patients with NASH and liver fibrosis. The study consists of two parts. Part one is consists of treatment duration of 72 weeks, so 1.5 and part two is the extension period, which is defined by events or end of the study, so clinical outcomes essentially. Inclusion is based on inclusion criteria, of course and critical years of screening biopsy to define the activity of NASH and fibrosis great and then patients who are randomized into three arms, placebo, lanifibranor 800 milligram once daily, lanifibranor 1200 milligrams once daily. And we have two doses in Phase 3 study based on the results of the Phase 2 native study where two doses were shown to be efficacious. So, the inclusion criteria are based on the SAT score. This is a score that is focusing on the activity of NASH and fibrosis which is the criteria that are important for treatment of NASH. And as I mentioned, randomization is one-to-one-to-one. So it’s an equal randomization to three groups and patients are stratified according to whether or not they have Type 2 diabetes. And as I mentioned, patients are F2-F3 fibrosis, the study will be conducted globally. At least a third of the patients roughly will be from the United States. The study is powered for 90% power and that led us to a sample size calculation of circa 1,900 patients for Part 1. Histology, liver histology is so important for the inclusion and evaluation of efficacy. So there…

Jean Volatier

Analyst

Good afternoon, everyone. Yes, as said in the intro, the year from the financial perspective has been a key and exciting year. We entered on the NASDAQ global market early July 2020 and just after and thanks to the positive results of the NATIVE Phase 2 study. We have reinforced our shareholders base with still U.S. and European shareholders of reference with balance of 60% European shareholders versus 40% American. So, therefore, we have consolidated our cash position at €113 million. And this situation allows us to operate through Q4 2022. We have in 1 year funded €120 million, of which of course, the $95 million on the NASDAQ, €15 million in Q1 ‘20 through an increase of capital, and a €10 million guaranteed loan from the French states, which leaves by the way a low level of indebtedness in Inventiva with less than 10% versus equity. We have of course in this momentum extended the analyst coverage as you can see. And in terms of market value, we are at less than €500 million, €471 million and $538 million. We still know that there is a gap to close with our peers. Next slide, Frédéric, quick view on the profit and loss accounts. So, it’s quite straightforward we still manage the expenses. They are under control. We had not expected revenues in 2020. Just to remind last year we got a milestone from AbbVie for next ones in the 2, 3 years and we also add revenue from Boehringer Ingelheim with the end of the collaboration last year. The other income still made up of the R&D French credit increasing a bit. We took benefit of a very interesting change in the regulation following jurisprudence from the consent data with regards to the subcontracting studies and eligible expenses and…

Operator

Operator

Thank you. [Operator Instructions] And your first question is from the line of Etzer Darout from Guggenheim. Please ask your question.

Etzer Darout

Analyst

Great. Thanks for today’s update. Just a couple of questions for me. Just wanted to know if you could talk a little bit about the timelines a bit, what it assumes about any sort of potential on delays with COVID, which we have seen sort of affect other trials and just overall kind of the pushes and pulls you assume for your timeline? And then if you could a little bit more color on what potential options you are exploring for compensated cirrhosis with [indiscernible] and where we could hear about them and maybe sort of what proportion of F4 patients do compensated cirrhosis patients that it represents? Thank you. Frédéric Cren: Etzer, for this question, so on the first one concerning the COVID impact on the trial, of course, this has been taken into account. Nevertheless, we are all aware that the situation is moving rapidly over the last weeks and months, positively duty to the beginning of the vaccination. So, all of this is taken into account. We have also selected one of the few global – that are experienced in development of the global Phase 3 NASH. They have put in place many I would say tools and approaches to facilitate the monitoring of patients nevertheless ensure that we need the patient to feel comfortable in getting back to the hospital. So, we need to continue the good trend that we have seen over the past week. Then concerning the F4 cirrhotic patients, maybe I turn to Michael or – yes I turn to Michael and maybe he can try that.

Michael Cooreman

Analyst

Thank you, Frédéric. And yes, I think the – on COVID-19 in addition to the ones that Frédéric mentioned has been also an adaptation of how clinical research is done in accepting more telehealth visits etcetera and lots of publications about that. So we are actually confident that 2021 will get to a normalization of clinical research activities. F4, we aim to study lanifibranor in patients with compensated cirrhosis who have a normal liver function and that’s corresponding to the box in this field today. So, the clinical outcome, the relevant clinical outcomes are on patients developing signs of decompensation, which are clinical signs such as ascites or worsening of liver function, which can be measured with the MELD score, for example, be little bit more to values measures. So, that’s the proportion of patients that we are aiming for. The subpopulation of patients for which there is currently no treatment and less of not so much clinical research activity, but represents a very high medical need. Thank you.

Etzer Darout

Analyst

Great and congrats on the progress. Thank you.

Operator

Operator

Thank you. Your next question is from the line of Lucy Codrington of Jefferies. Please go ahead.

Lucy Codrington

Analyst

Hi, there. Thanks for taking my questions. This is helpful for me. And so just following up on the Phase 3 timelines, I just want to be clear, is there any room for an improvement on these or is that – is the timeline be given already a Blue Sky scenario for the trial? And secondly, I just wanted to confirm that the cash run-rate doesn’t include any anticipated milestones within that? And then finally, just on the central histopathology review in the Phase 3 is that – can you remind me is that standard practice in NASH Phase 3 trials or is that something that just you guys are doing? Thank you. Frédéric Cren: Okay. So, on the milestone, Lucy, so we are always extremely prudent. So we take into account all costs and we never take into account any potential milestone. So, if we receive a milestone from AbbVie or any other collaboration that would be an upside. Blue Sky, I know this is I would say for the Phase 3, these are the realistic, what we believe is achievable. We have been I think working with the right CRO. We have selected the right number of sites. And we have been going through I would say reinforcing our team at all levels, of course, clinical operations both in Europe and in the U.S. We are increasing the contracting team. We are increasing the regulatory team. So we feel confident as of today that we can achieve this – the timing as we laid them out in the – during the presentation. Then concerning your question on the pathology approach, this was extensively discussed with the FDA, I will turn to Pierre, he can explain that more in-depth.

Pierre Broqua

Analyst

Yes. Sure, well, I will turn it to Michael afterwards, but it’s true that we had this was a topical discussion with FDA. And I think that we actually made the proposal and that was accepted and makes a lot of sense and would really guarantee the good quality of the reading of the biopsies, but Michael, if you want to add on that please?

Michael Cooreman

Analyst

Sure. But I can only confirm yes, it’s been – our procedure is discussed with and agreed with by the FDA. So that’s I think relevant point. Histological evaluation of the therapeutic efficacy and NASH standard approach since the effect on fibrosis specifically has been shown to be or let me put this way, fibrosis progression is an accepted surrogate marker for clinical endpoints as the most relevant element that determines the prognosis of patients. And the NASH activity reflects the necroinflammatory injury of the liver. So the combination of both reflects the entire spectrum of the disease, biology of NASH. So this histological evaluation is accepted as a surrogate endpoint and our procedure the way we do it using two experts, pathologists, by which you mean pathologists who have been – who are recognized as really true experts in this field, one on each side of the Atlantic. That’s certainly an accepted approach by the FDA following our discussions with the FDA. Thank you.

Operator

Operator

Thank you. Your next question is from the line of Derek Archila of Stifel. Please go ahead.

Unidentified Analyst

Analyst

Hi, guys. This is Jack on for Derek. Thanks for taking our questions. First on the cedirogant program, how do you view this program? And are you looking to develop the drug in plaque psoriasis or are you looking at like plaque psoriasis as more of a proof-of-concept? And if so, were you looking to take the drug forward? And then also, could you help us understand I guess how it could be differentiated from others in development? Frédéric Cren: So from – first of all, from a contractual point of view, the development and strategic orientation isn’t the end of AbbVie, they will decide to where to position and how to develop this drug and is actually we view that as a great opportunity for us because AbbVie has been shown in the past great ability to be able to develop compounds in several indication in the autoimmune field. So to your question, there is clearly a potential for cedirogant in moderate-to-severe psoriasis. Given its mechanism of action, it’s actually eligible to other indications such as IBD, Crohn’s, RA and others. Then to the last question about how we differentiate, I think the easiest way to say that is just to summarize as AbbVie does, the target product profile of cedirogant in Humira in the field, so clearly due to the ROR-gamma mechanism of controlling IL-17 expression, we clearly think that cedirogant does have potential in the efficacy of biologics, but with the great advantage of in your oral once-daily pill and also we expect higher safety due to shorter life.

Unidentified Analyst

Analyst

Great. That’s helpful. Thanks, guys and Congrats. Frédéric Cren: Thank you.

Operator

Operator

Thank you. Your next question is from the line of Lenny Van Steenhuyse of KBC. Please go ahead.

Lenny Van Steenhuyse

Analyst

Good afternoon and thanks for taking my question. Pierre earlier mentioned of course an interest to explore lanifibranor applicability, so both in the compensated cirrhosis setting and potential combination therapies. I was wondering for the short-term, is this mainly something that’s being looked at from the preclinical level or do you also consider clinical efforts and in the relatively short-term? And perhaps linking to that, given the current level of funding and budget for required for a Phase 3 NASH trial, are you confident that it’s going to have sufficient funding to support such broader development of lanifibranor? And is this included already in your cash runway guidance up to fourth quarter of ‘22? Thank you. Frédéric Cren: So concerning your question about the guidance, no, it does not include any potential clinical development of lani in combination with other drugs or in F4 patient. And then to your question, do we – is this clinical or preclinical effort, I would say it’s more clinical effort that we have in mind with exploratory study that could confirm the benefit of combining lani with other anti-diabetic drugs or other NASH drug as explained by Michael in his presentation.

Lenny Van Steenhuyse

Analyst

Alright, thank you. If I may squeeze in a second one perhaps more on the R&D spending into 2021, I was wondering if we can expect similar level compared to 2020 given the end of the Phase 2b mid last year and likely to follow-on Phase 3 trial ramping up by middle of this year or should we expect some increases as the organization overall increases as well? Thank you. Frédéric Cren: Yes, so maybe I’ll turn to Jean that can explain we have modeled the cash runway and the increase or evolution of R&D spending moving forward?

Jean Volatier

Analyst

Sure. Yes, as Frédéric said, we have setup discussion with the current resources and with the current program on the Phase 3/4 F2-F3. Also with regard to the existing cash position, it allows us to investigate really all the possibility to optimize our cash and you can imagine that there are some options to work out and we have the time to optimize those options. So, obviously, the costs for ‘21 and ‘22 will increase with the Phase 3, you know how this kind of study can cause, but the increase in ‘21/22 is included in the guidance for the cash for time being. And while are we talking 2 years from now, but we will probably be able to analyze additional funds that we will be able to get in the next year or so too much this very important Part 1 deadline.

Lenny Van Steenhuyse

Analyst

Alright. Thanks very much for your comments.

Jean Volatier

Analyst

You are welcome.

Operator

Operator

Thank you. Your next question is from the line of Jean-Jacques from Bryan, Garnier. Please go ahead.

Jean-Jacques Le Fur

Analyst

Hey, Jean-Jacques Le Fur from Bryan, Garnier. Thank you for taking my question. The first one is regarding the biomarkers study, you started with Jérôme Boursier, In case if you – it would be positive if you can be able to identify some of them as really being linked to lanifibranor. Could we think or could you seem to try to develop a sort of companion diagnostic for lanifibranor? And my second question is regarding the combo you want to study or you have in mind, and particularly the PPAR plus SGLT2 or lani plus SGLT2, since SGLT2 were not particularly natural, if I may say, with the clinical results we have enhanced right now. So my understanding is that you want to use the SGLT2 to reduce the weight loss or to mitigate the weight increase from lanifibranor, don’t you think if it’s the case I may be wrong? But if it’s the case, it could be a very costly option just to control the weight gain or the weight loss? Many thanks. Frédéric Cren: Maybe for the biomarkers, I will let Pierre answer and then we will – Michael will answer the part about the rationale for developing lani with the SGLT2. Without anticipating his answer, of course, there are beyond the potential control of weight many other benefits that could be expected from such a combination, but maybe first of all biomarkers, Pierre?

Pierre Broqua

Analyst

Yes. So to your point – to your question related to biomarkers, so the objective of the combination we have put in place with Jérôme Boursier is that we are using the NATIVE database of 80 biomarkers and the results obtained in our patients under lanifibranor treatment is to identify when he will perform a multivariate analysis of this database. And that should end up with the identification of the biomarker or several biomarkers or a composite score. That would help identify the patients that are currently responding histologically to lanifibranor. Once we have made this hypothesis to this call, we will test this hypothesis during the NATIVE 3 trial to see if we confirm that the patients that are improving histologically show also the same biomarker signal. I think that this is going to be very useful in the commercial setting, if of course when validated for what is discussions on pricing and reimbursement, because it’s clearly an asset, if you can provide as you say a kind of companion diagnostic to be able to monitor without doing a biopsy to monitor the responders on the patient, how the patient responds to the drug in the real life. So, that is the overall objective of this work. And Michael, regarding the combination with SGLT2, if you want to reprise?

Michael Cooreman

Analyst

Sure, and thanks for the question. So, SGLT2 and lanifibranor indeed providing a good rationale for combination and I believe it’s both. It’s both the secrecy and the weight gain as mentioned. So weight gain is perceived as something that is not desirable, even though we know that weight gain with lanifibranor is metabolically healthy in the sense that it’s not visceral fat, but less active or not active to visceral accumulation and subcutaneous fat. Having said that, weight loss, given that or reduction in weight given that the majority of patients with NASH who are overweight is a benefit of the combination therapy, of course, but there is also the rationale to further improve the efficacy. Lanifibranor is important on a self-standalone treatment and that’s shown by the Phase 2 study and the data of the Phase 2 study. There is still room to improve on efficacy for every pharmacological agent. So, that’s an additional benefit. Now, the SGLT2 inhibitors by themselves as monotherapy for NASH are not very promising that is true and the non-clinical data have been done in that regard. We are not strongly supportive, I would say, of developing this kind of compounds for NASH by themselves, but on the other hand, they are in part of combination treatment, where there is complementarity in addressing the underlying disease biology of NASH. There is a good reason to anticipate that there is an improved effect of the combination on markers of insulin resistance glycemia control, lipid metabolism, where SGLT2 inhibitors too have an effect and which are important upstream mechanisms of NASH. So, I do believe that the rationale is both to improve – to further improve the efficacy as well as to address aspects of weight gain. Thank you.

Jean-Jacques Le Fur

Analyst

Okay, thanks. Very clear and congrats.

Michael Cooreman

Analyst

Thank you.

Operator

Operator

Thank you. Your next question is from the line of Zegbeh Jallah. Please go ahead.

Zegbeh Jallah

Analyst

Hi, guys. Thanks for taking my question. Just have two quick ones. So, the first is the FDA recently noted kind of being interested in prognostic or efficacy biomarkers and kind of has welcome data from sponsors to help build evidence around it. So just wondering if you can give us a sense of how the EMA might be thinking about that, based on some of your recent discussions? Frédéric Cren: To understand your question, Zegbeh, you are interested in understanding the regulatory position on the development of biomarker and now those could replace biopsy, is that the core of your question?

Zegbeh Jallah

Analyst

Exactly. Frédéric Cren: I think the alignment between the two regulatory agencies, right, FDA and EMA.

Zegbeh Jallah

Analyst

Correct. Frédéric Cren: Yes. So, well, I think the EMA is really in the same line of same position than FDA, so very supportive of having sponsors exploring and developing biomarker, non-invasive technologies during the Phase 3 trial in order to optimize the use of those in diagnostic and prognostic or so in the commercial setting. So, those agencies are totally aligned. And I think that the program that we have put in place within our NATIVE 3 trial totally match the expectations of those regulatory agencies.

Zegbeh Jallah

Analyst

Thanks, Fréd. And then just a quick one, the FDA also expressed an interest in seeing positive effects on lipids, glucose and so the cardiovascular benefits you showed in lani was really nice to see. But we are just wondering from a commercial perspective, how differentiating the benefits on cardiovascular risk could be based on some of your recent questions that you have been having with KOL? Frédéric Cren: Well, in terms of differentiation, so I think that if we simply look at the metabolic aspect of the drug both improving glycemic control and dyslipidemia in NASH patients with diabetes or NASH patients with insulin resistance which actually would represent close to 100% of the NASH cases. This is clearly a differentiating factor over the current competition as I don’t think that – well beside maybe semaglutide or none of the other competitors are capable of improving glycemic control in those patients. Regarding cardiovascular risk reduction, where I tried to say that, of course, improving diabetic condition, improving the dyslipidemic condition is something that would likely go into a reduction of cardiovascular risk, but there is also a past history with pioglitazone that you can refer to where in large studies like glycoactive or like high risk you actually see a reduction of cardiovascular death, number of myocardial infarction, reduction of number of strokes. So, there is already a nice theory of clearly of reduction of cardiovascular risk with compounds activating PPAR gamma like pioglitazone, for example. So together I think that yes, with PPAR activation, there is a probably likelihood that we will also see an improvement in the cardiovascular risk in NASH patients.

Zegbeh Jallah

Analyst

Thanks, Fréd. Looking forward to the Phase 3 study start and then can you just lastly let us know if you anticipate providing any regular enrollment updates or any updates on the study progress? Frédéric Cren: Yes. Usually what we have been doing in the past is to communicate on key events. So, the NASH we view is as important will be the first patient, first visit and we certainly will communicate on when we achieve this important milestone.

Zegbeh Jallah

Analyst

Thank you.

Operator

Operator

Thank you. Your next question is from the line of Michael Morabito from Chardan Markets. Please go ahead.

Michael Morabito

Analyst

Hi, team. Thanks for taking the questions. First, I just wanted to know what type of data, what kind of readouts should we expect when AbbVie reports the initial clinical proof-of-concept data in the second quarter? And secondly, I was just wondering, can you clarify you mentioned that patients will be stratified in the Phase 3 NASH trial based on F2-F3 status? So, is this F2 versus F3 or F2 and F3 versus other levels of fibrosis that might enter the study? Frédéric Cren: So, on AbbVie, so the current trial will include several biomarker efficacy including body score at 4-week and these are the – I would say the measurement that will allow to determine if the drug has achieved or not proof of clinical concept. Concerning what level of communication AbbVie will do this I am unable to answer because of course they are in control of the communication in the data they want to release. Then on your question about the trial, I will try to give the answer. I think I know the answer. But if I am wrong, Michael, please correct me. It’s going to be a certification, F3 versus F2 in the Richmond office, three patients I think we are targeting 55% of every patient in the study.

Pierre Broqua

Analyst

Yes, that is correct.

Michael Morabito

Analyst

That’s it. Thank you very much.

Operator

Operator

Thank you. [Operator Instructions] And we also have a question here from the line of Ed Arce from H.C. Wainwright. Please go ahead.

Ed Arce

Analyst

Great. Hi, everyone. Thanks for taking my questions and congrats on all the progress lately. I have three. First is your surrogate primary endpoint for the Phase 3 depends on both NASH resolution and fibrosis improvement, really a precedent setting endpoint there. In addition to the NATIVE results, which were clearly robust and positive, what gives you the confidence in lani’s activity on fibrosis, especially with regards to work that you have done that shows that lani has not just indirect effects on fibrosis, but direct effects? That’s one. Two is why did you choose to evaluate both doses in the pivotal Phase 3? Is that perhaps to allow for titration or better ability to manage a disease on the label once approved? And then third and finally, given that your cash runway is through the fourth quarter of ‘22 and your readout is expected in the second half of ‘24, how do you plan on covering the shortfall for the Phase 3? I mean, are you perhaps looking at out-licensing certain regions or are there any potential options for perhaps non-dilutive financing? Thanks so much. Frédéric Cren: Well, thank you, Ed. Three, they are good questions. So maybe I will let Michael cover the question about the fibrotic of lani and the rationale for the [indiscernible] and I will cover the cash runway.

Michael Cooreman

Analyst

Yes. So, I will start Microlipid complete [indiscernible]. So, your point is the confidence in lanifibranor anti-fibrotic effect, I think is strong. We have seen with the high dose that in 6 months we were able to meet the endpoint of improvement of fibrosis by one point without worsening of NASH in more than 40% of the patients treated with the lanifibranor high dose. Looking at the biomarker data, we have seen that the 800 million produced a significant decrease in fibrosis related biomarkers such as PRO-C3. So we think actually that the low dose would be more anti-fibrotic on the longer term trial. So by extending the duration of the trial from 6 months to 18 months, I think that would give a good sense for the low dose to a more potent anti-fibrotic activity than it did in the 6-month trial. And finally, as you know, there is a lot of technical evidence supporting the direct anti-fibrotic effect of lanifibranor, we have notably published a lot of work done in isolated human hepatic steroid cells, where we see an inhibition of the activation of the cells by lanifibranor and the different type of stimulation and the TGF-beta or stiffness. So there is quite a consistent biology between the in vitro, the in vivo clinical results and the clinical results, including histology and biomarkers, which for us gives us really good confidence that the drug would be able to have high chance, high probability of success in this composite surrogate primary endpoint. Frédéric Cren: Second question was about the rationale for the two doses and then the third question was for…

Michael Cooreman

Analyst

Cash runway. Frédéric Cren: Cash runway, so the cash runway and yes, you are right, so as Jean said, we have 113 at the end of the year, that’s more than enough to launch the NATIVE 3, but we need to close the gap if we want to find in that study until the readout of Part 1 and we are currently with the team with Jean looking at many options. They go from innovative options, like going back to the market to doing licensing on lani for regional or global deal licensing for odiparcil. We are also looking at other more creative approach, such as depth or royalty deals. And I would say that given our current cash position, which we have the time to analyze the several options and really take the right decision at the right moment. What is important to retain is that currently we have really not slowed down in anyway in the launch of the Phase 3 by our cash position.

Pierre Broqua

Analyst

For the question on two dose in Phase 3 so before – maybe Michael you can intervene, I would say that, of course we are aiming at the registration of the two dose. Because as you say this would bring a lot of flexibility in the clinic or in patients, investigators once the drug is on the market. But maybe, Michael, you want to add some on this question?

Michael Cooreman

Analyst

Thanks, Pierre. I think an important rationale to evaluate two doses is the effect on the relevant endpoints. And I would say fibrosis is important. So, the NATIVE Phase 2 study was half the year 26 weeks, we see in somewhat larger effect size up to 1.2 grams on fibrosis at that point. So, there is an expectation that the 800 milligram may have an increase to the effect size on fibrosis, the longer you treat. So, we are taking two doses forward will give us a lot of information about the 800 milligram as well with regard to its efficacy compared to do 1,200 milligrams. Thank you.

Ed Arce

Analyst

Great, fantastic. And then perhaps just one quick last one if I may, given the long lead up time for the Phase 3, I am just wondering if there is any opportunities for sort of interim results or is that perhaps really we are looking at milestones from perhaps other studies like in the F4 patient population? Frédéric Cren: Yes, you are totally right. I think the key milestone and key news will come from other trial both with lani. So, we touch about some options that we are looking in combination in F4 patient. There is a study with Professor Cusi that will be an extremely interesting study confirming the strong anti-diabetic properties of lani. We will also have updates on cedirogant. This is an important trial that is going on. If we obtain POC, the program will be much more visible in AbbVie pipeline and that will be certainly – and it’s an exciting stream of news from the – for the company. And then as I also said, we also have odiparcil. We are convinced about the potential of this drug in MPS. We are convinced about our strategic decision to find a company that has the resources financially in human to carry it forward and that also will provide updates for the company.

Ed Arce

Analyst

Great, thank you so much, Fréd. That’s very helpful.

Operator

Operator

Thank you. There are no further telephone questions at this time. Please continue. Frédéric Cren: Very good. Thank you. Because I am looking is there any question on the net, but that is not the case and we have actually run out a little about our time. I just can only thank you for attending and following us. As you know, it’s been an extremely exciting 2020 and I can assure you that 2021 looks even better. So, we are very excited by the future. And we are very grateful for your support and the time you have spent working with us. Thank you very much and have a great day.

Pierre Broqua

Analyst

Thank you. Bye-bye.

Operator

Operator

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