Q1 2020 Earnings Call

We are.

And that are two clinical trials that we were recruiting in Pacific and are fully enrolled furthermore. There are sufficient inventory of clinical trial material to conduct these online programs having raised 43 million dollars early in the quarter. Our cash position is strong and we have sufficient cash to get us into the second half of 1221.

Go we continue to monitor the evolution of the covid-19 crisis and the potential impact to our business are fundamentals. Remain unchanged our guidance regarding clinical trials and cash Runway remade unchanged.

Let's move into a brief update on our programs starting with o. We're just months away from the top line of our pivotal trial data off. The Petra Quantrell is fully enrolled with 62 out of a plan sixty patients, and we expect top-line results in the middle of the year.

With our current clinical trial already having achieved full enrollment and with adequate clinical trials of drug Supply the covid-19 risk is less significant off. Then it would have been a bit of in the case a couple of months ago or more than three-quarters of the patients have completed the pet pig one trial which is excellent progress versus our most recent update month. We indicated that we are at more than two-thirds while taking the utmost character protect the safety of patients in the trial. We are confident in our ability to collect the remaining data.

Why do we believe this for the brightest primary endpoint? We collect the data remotely with a smartphone like tool and this is unchanged since the covid-19 Crisis began month for the eu's serum bile acid primary endpoint. We expect to collect the remaining blood samples as many of the trial sites are children's hospitals that are often away from the emergency rooms and given that oh to fix that may be a life-saving therapy. This trial is often prioritized in these settings.

For the few other sites where there may not or this may not be the case. We implemented the workaround. Thus far. Our team has been doing a really a great job of addressing each situation on a case-by-case basis and we're now in the home stretch for data collection. We look forward to potential proven launch in the second half of 2021.

In the meantime, we're laying the groundwork for our regulatory submissions and accelerating commercial launch preparations. We need to make excellent progress in manufacturing and supply chain planning select package actors for the US and the EU selected a partner to help us execute our patient support program in our collaboration with physician and patient communities execution the CMC plan agreed with the FDA in the fall of 2018. We are using the plan commercial formulation RV three studies and registration batches are on stability off.

The moving to bellary atresia the bowl pivotal trial biliary atresia and the use of voting fix bad in treating liver disease is now underway. We are very pleased to announce that we've initiated the first clinical trial sites for this President setting pivotal trial regarding covid-19. We are in the site activation stage and we plan to conduct most of the work remotely during this period in the latter part of the year. We will be in hospitals for some site initiation visits, but would hope that access would have resumed by that time bold is a double-blind randomized placebo-controlled study to evaluate the efficacy and safety of eau de VIXX about compared with Placebo in children with biliary atresia undergone a Kasai procedure. We plan to initiate seventy to seventy-five sites globally with an enrollment Target of approximately 200 patients.

Biliary atresia is the most common rare pediatric cholestatic liver disease and given the size of the patient population. It represents a significant commercial opportunity with this study will provide valuable data on disease modification that will be helpful to payers and other stakeholders both the FDA orphan designation in biliary atresia off now quickly looking at alagille syndrome that we received FDA feedback on our trial design and we'll be sharing more details when the design is finalized but this trial will be more like the prefect of them in the Civil Trial you continue to anticipate beginning the allergy or pivotal program by the end of the year and expect he'll Topline data to be available between the announced and biliary atresia top find results.

They're approximately 100 key metric herpetologists in both the US and Europe many of these Physicians will be participating in all three pivotal programs. And these investigators wage very familiar with out a Vicks about and Alvarado.

So shifting to our efforts in Nash and had a liver disease in q1. We announced full enrollment of 47 out of a plan 46 patients in our first Feast to trial with in fact continue to expect Topline data by the middle of this year. Most of the trial sites in the study are community-based clinics rather than hospitals which should help with continuity during covid-19. This proof-of-concept study is the first ever study ever conducted in both in apple D and patience with an I bet inhibitor and we're looking for the combination of both deliver markers cardiovascular risk factors in favorable GI tolerability.

In addition our Japanese partner, is sponsoring a study in Japan with a hundred patients using a higher dose of melafix about 10 milligram. We expect the data by the end of this year or early next year.

I given the unmet need an ash. We believe our approach could provide the potential for the optimal balance of liver and cardiovascular efficacy with excellent convenience and not you know, these two studies will provide valuable insights to inform the next step to development for a potential partner. We're working to complete ind-enabling studies with our lead preclinical candidate that offers a novel mechanism of action. We believe that the combination of the two elements that these two studies and the emerging on the lead preclinical candidate could create a compelling case for a potential partner and create additional value for Alvarado.

Finally given that we are rapidly approaching. What is arguably the most critical data event in Alvarez development as a public company. I'd like to take a moment to talk about why we are confident that pet pick one will yield results that will position out of it's about four Regulatory and Commercial Success in the US and EU.

On the topic of the brightest endpoint in pet big one the confidence in our ability to demonstrate motivates vets impact on pruritus begins with our proprietary pruritus message to Old name precision.

We developed this tool for our fees three patient population testing it rigorously with both patients and caregivers and in close consultation with the FDA. It's just a simple intuitive four point rating scale like the winning scale used in our face to study that distinguishes. Each rating with pictures words numbers odd dollars. Now, we recognize there may be some variability measuring prices and if taken steps to mitigate this risk through powering assumptions trial sizing and trial length Thursday. We have powered the study conservatively, assuming a moderate treatment effect and a significant Placebo response.

Additionally, we've made the study larger and these elements lead to a powering Assumption of well over 80% as in many other studies, we expect that any placebo effect that we tend to diminish over time. And once again in consultation with regulatory authorities, we lengthen the study to 24 weeks while there been other trials and other therapeutic areas may fail to reach their primary endpoint using rating scales. We believe that the pet pig one trial is different due to the extreme severity of the disease patients. Tell us a parade with these are better or not.

We believe that the ease-of-use and expected high compliance with our measurement tool as well as the trial design will underpin the results as a result. We have a high degree of confidence in our potential to achieve success for the private standpoint.

Why do we believe that? Oh, the victim benefits are aspiration to develop best-in-class products. It is born first from the album teams multiple Decades of experience in developing. I bet Inhibitors among other things this domain expertise is evidenced by our ability to lay claim to having developed the first-ever commercial available. I've added the amateur with Alex about

when we think of a

Potential best-in-class product we must consider the product itself and the data supporting is safety and efficacy.

What is Vic's about is the most potent iPad inhibitor ever since the size and it is highly selective with minimal systemic exposure. But it makes the back and give be given once-daily with a choice inconvenience sprinkle formulation. For instance. That can be mixed with the pure. I'd or small capsules for older children. These capsules do not need to be refrigerated the clinical data supposed to fix about our strong and consistent in phase one would have expect demonstrated consistent bile acid lowering and a low rate of diarrhea in the two lowest dosage in fees to those people patients eligible for the phase three study achieved a mean reduction and bile acid of over 70% in four weeks, which is similar to observed in bile acids and surgeries.

In addition to powerful biological production, oh to fix bad reduced prices and improve sleep with no diarrhea observed during the four-week treatment.

The feast that the country is the first and the largest pivotal prospective randomized placebo-controlled trial in Pacific ever initiated will analyze approximately 40,000 on active drug versus 20 on placebo.

Now looking at it as a commercial proposition. I want to revisit how we think about the analogy of patient populations. There's no prevalence data or registry Registries that exists to provide a clear view of population size. Therefore we use secondary resources that are available and primary market research to estimate populations wage applied the published incidence rates in estimating medium survival rates to Regional populations. We look at emerging Natural History sources, like the Napa study has points of comparison along the way we are focused mainly on the U, but in a broader analysis to other regions as part of our regional partnering discussions,

There is a significant opportunity in the rest of the world. And we believe that the total number of pediatric cholestatic patients in the world is inaccessible our current estimate of 30 to 40,000 dead have ongoing efforts to refine these numbers and we'll share further details as the work is completed.

So hope you can see that we made significant progress with our development programs and remain on track to deliver both compelling new data and forward progress throughout the year with my pleasure to turn the call over to Simon for a financial update Simon.

Thank Rob. Let me quickly summarize all Financial results q1 2020.

Revenues for one and half million to the first quarter of the year compared to six million in the same period last year the increase was primarily due to all team and you received from, which is passed on to healthcare royalty Partners as part of an agreement in December 2017 to monetize the royalty wage.

Research and development expenses for 16.1 million for the first quarter of 2020 from eight point three million in the same period in two thousand and nineteen month increase for the first quarter was primarily the result of program expenses for an exit as well as Personnel costs Thursday. We continue to increase our program activities in the head count.

A q1 general and administrative expenses were eight point two million compared to 5.3 million to the same quarter in 2019. The increase was attributable to headcount and Commercial Readiness expenses in preparation for the anticipated approval and launch of its about in Pacific next year.

Other operating experience with 6.8 million in the quarter first is 2.3 million last year an increase of 4 and 1/2 million due to the impact of foreign exchange rates on intercompany loans as the Swedish krona declined in value. There is no cash impact of these changes.

Not lost the first course, it was 31 and 1/2 million were a loss of $2 23 per share compared to a net loss in point seven million dollars or a dollar thirty-nine loss per share in the first quarter of 2019.

As of March 31st 2020 we had a balance of 150.5 million in cash and cash equivalents compared to 131.8 million on December 31st, 2019. The higher cash balance is a result of $43 million of net proceeds from our Equity financing in early February, excluding the impact of Foreign Exchange on intercompany loans. We continue to anticipate operating expenses for 2020 of approximately a hundred million dollars a cash balance be sufficient feet are operating needs into the second half of 2021 with that. Let me turn the call back over to one for closing remarks, Ron.

In summer, we all know that covid-19 is having a sweeping impact across industry in our society as a whole mess far Alvarado has persevered extreme and we're in the fortunate position due to the status of our programs as we eagerly await top-line results from the ode of expensive trial in effect wage making excellent progress across a wide range of lunch preparations, including manufacturing supply-chain reach support program and valuable ground with physician family from patient organizations off or can access work could feel forced planning at the same time. Our bill have little trial is moving ahead and we are near finalization of our pivotal trial design in Allen.

behind all of this continues

To make progress with the elephants breastfeed to trial fully enrolled and I Indian gambling studies underway with our lead preclinical product candidate. We were me solidly optimistic the second half 2020 is shaping up to be the culmination of many years of great science and hard work at a liberal.

With that we'll open up the call to questions operator. Thank you. If you would like to ask a question, please press star one on your telephone keypad up. Your line is in the question to you may press star to if you would like to remove your question from the queue and for participants using speaker equipment. It may be necessary to pick up your handset before pressing. The the turkeys. Our first question is from Yasmine, right? He me with Roth Capital Partners, please proceed.

Hi team, thank you for taking our questions and thank you for the update. Two questions. One is headed into the data. We're expecting also to see here. Can you maybe it's just some light into how valuable the transferability will be from ballasted reductions and that patient population to the upcoming P6 study. And then the second question is, can you give us a little bit more color in regards to what elements of the allergy little little study remains to be finalized and what are aspects of it that are known and thank you again for taking your question.

Good morning, Jasmina. Thanks very much for joining the call, you know make a few comments and you know, maybe pad you can just add on Thursday. I've missed anything, you know, I think that you know, we think about the Nash data and the impact develop, you know in you know, these are different compounds too bad in eau de VIXX about and and so, you know in general, you know, we're going to be expecting, you know reductions in bile acids, but I do not think that these are these are transferable because you know to fix a bat is the most potent bad inhibitor ever ever synthesize and it's very much specifically being used in Nash. I'm sorry in in the Pediatric cholestatic. Yeah, and that's why we've designed it for that and then and then as it relates to the allergy pills studies, you know, it's dead.

You know pretty much we're just putting some bows on things. We've got some nice feedback from the Regulatory Agencies. We have a direction of what we need to do and you know will provide you some further details that I'm anything there Pat.

Yeah, so I think the thing that ties these together is a reduction in bile acid in the fact that elevated bile acids cause ongoing a paddock damage and that's kind of regardless of the indication. It's more pronounced with motive except and the Pediatric all static diseases where the serum bile acids are much higher and and and and we expect to see how long these modification not only impede hit but in biliary atresia and and and the other cholestatic diseases in Nashville, there's also data to show that as you move from a normal liver to a fatty liquid soon as you get this elevation in serum bile acids and preclinical work shows that reducing bile acids with I bet inhibition actually decreases the fiber optic package on it up Nash in addition in the nests there the other

Attributes of the I bet inhibition The increased glucose sensitivity that reduction in cholesterol and the other things that will will add to the impact in the space.

And in terms of the allergy study, I think Ron's exactly right. So we agreed on the major things the in points that the timings were working on on other things like exactly how we're going to look at the delay algorithm for drug-induced liver injury cuz this is a a group of patients that start out with high levels. And so they're just a few little things we need to to sort of we are very close to a final designs.

Thank you. Thank you.

Our next question is from Leanna misato's with wedbush Securities. Please proceed thank you for taking my question sign and you mentioned above a hundred million in guidance for op-ex this year. What is due to look like versus q1. We're going to see a steady increase or real cute to be lower because things are being done virtually. So we happen guided explicitly to What expenses will be quarterback, but obviously, you know, a hundred million dollars roughly this year is is roughly twenty-five million a quarter on an underlying basis when you've cleared the any foreign exchange movements, which as I mentioned is is non-cash related and I think it's sad to say that, you know as things like wage.

The trial. Winedown Yeah, we actually do have some typically slightly higher expenses at the end of the month sale rather than in the middle. Um, but that's sort of offset by the fact to some extent that you know, there's less travel now to sites et cetera with the stuff is being done remotely unlock the hiring perspective. Um, I think really what you should think about from a people point of view as we will be adding through the year month and in a gated manner. So the way we're treating this is were hiring those people who are absolute must haves for the launch ahead of top-line data readouts. So things like commercial and um medical Affairs leadership, but we're not adding until after toppling data headcount for things like field forces. Uh, and yep,

I grew up who are not Mission critical until we have done the top line data readout, but overall, you know, I would say we're building over time, but I'm not going to be exactly specific quarter-to-quarter. Okay. Thank you.

Thanks, Liliana. Our next question is from Yang with Jeffries. Please proceed.

Thank you. So for biliary atresia right on track, so congrats. So looking at the clinicaltrials.gov data is expected in May 2024 primary completion date. So question to you is the easier to kind of interim look that you could life get to provide some data read between now and then

Yeah, thank you for the kind words, you know and you know, you know all that Pat answer the question, but I think we're pretty excited about getting this precedent-setting study up and going off of credit to Pat and to you know, his organization. You want to add a little bit to that.

Yeah, so I think there were multiple conversations with the Regulatory Agencies about looking at kind of interim analysis and and based on biomarkers. But the regulatory agencies are really set on the hard clinical and point of survival with Native liver at two years. And in that really there wasn't much of an appetite from a regulatory point of them to look at the biomarkers early. So there's not a formal interim analysis. There will be kind of ongoing review by the data monitoring committee, but not as as a formal analysis.

Thank you and run. You mentioned that you guys are working on more of the commercial opportunity refining given the lack the prevalence and registry data for this patient population. They said based on your face history enrollment and Screen processes. Do you have any kind of number of a patient in mind that you could have identified by the time you launch the product?

No, thank you. You're yeah, that's you know, that's the type of work that we're that's ongoing right now. I think we're pretty pleased with being able to slightly over and roll the study lounge, you know, we actually had a lot of interest in this study. We we consented over a hundred children as well leave the demand. Is there a Pamela and our team right now both are looking at that on a site by site basis and you know as time goes on we hope to provide you more details in that regard.

Thank you for taking the question.

Thank you. Our next question is from with.

Hi, good morning. Everyone. Thanks for taking my questions and congrats on the continued progress. Especially the the initiation of the Bold study. So two questions for me starting with that study ba. I know you mentioned there will be sort of transition throughout the year off from Mostly sort of remote or virtual activities over the next few months and then and then more on-site activities later in the year, you know, if if access is is allowed given given depend emack. I was just wondering if you could give us a bit of details as your um, um going through the year on what your plans are. Ugh. Not only what you have in in plan, but God

contingencies if uh

The access is less than you would hope for.

Add first of all, good morning and thanks very much. You know for the question, you know, I think you know from a covert prospective from biliary atresia trial perspective as well. We're doing exactly but to be doing right. So a lot of the work right now is with the cio's. I Arby's it's contract and Pat's and his team have done a great job in in doing that worth getting up and going. Yeah. We just anticipate though for some sites. We need to get into into into the hospitals and it will be we cannot do that role but as the year progresses we had dissipate getting into those hospitals. And so, you know, that should be able to get us up and going with sites now, obviously if there are some records of it and it makes it more difficult that we're not able to get into the hospitals and that will make it that will make it challenging but I think you know you have any what's you know in the public domain now every wage?

Patient suggest that as we get into the late Summer and the fall we should be able to be into these institutes and and that should be fine from a timeline perspective.

Okay, great. And the other question I had was as you mentioned, there's a lot of interest in better understanding the the primary endpoint hear the pure itis endpoint for the study and you shared a little bit of the specifics of your proprietary Precision Tool as you call it and so I was just wondering if you could also share a bit more of the details of that tool with regard to particular the improvements that you made on the Weddington tool also a four-point rating scale as an analog as you were divorced looking at

Thank you. Yeah, great. Thanks. Why don't why don't you take that?

Sure. So as you point out at the Whittington scale is a 0 2 4 .4 deal and and that's what we use in with with 0 being no itching and for being the most intense itching wage in in that was developed or patience with cholestatic liver disease, you know early on in in the early transplant by Peter where they end at the University of Chicago at the time. So what we've done is we take in that scale and put it into an electronic format and and so it fits into something that's about the size of the phone and the patient is ask, you know to drink your price either over night or during the day and in addition to the numeric scale as as Ron points out. It's also matched with kind of the smiley or frowny faces and these frowning boxes are actually collard green bean good to read being the four and and the the development work, you know kind of the content validity and the questionnaires that went into both the patient is dead.

Caregivers show that just really kind of improves the ability to differentiate on on both the parents point.

View in the The Observer reported outcome and in the patient in in the patient reported outcome. So it really just takes the same concept. That's that's been used since the eighties really in terms of rating pruritus in pediatric prosthetic liver disease and puts it in a format that is is much more patient and caregiver friendly and in in enhancing with with both the colors and the text as well and just to add you know, you are blinded to the data and the pet pick one study, but we do know the rate of years of the tool and we're actually very pleased at the high rate of usage and the amount of data that we have so that would suggest the tool is relatively easy to use your for the for the parents.

Great. That's that's excellent detail. That was that was it for me and congrats again on the continued progress, especially in the current environment.

Well, thanks very much.

Our next question is from Alan Carr with Needham & Company. Please proceed.

How do you think for taking my questions a couple of them swim around?

P sick in terms of regulatory timing, are you planning to submit and at the same time or there's going to be staggered and am curious about allergy syndrome if I had some conversations with Regulators if they're nice a line in between the with the day and fifty a month. Thanks.

So a couple of regulatory questions down. Thanks very much. Thanks for joining joining us. You know, I think our plans are on the back of pepek one dated to to both authorities around the same time, you know, they're obviously can't do them all the exact same day. So around the same time. So that's the overall talent and we would be looking to have a single protocol for allergy are pivotal program for both the US and Europe.

And one other one that I have for you, you mentioned earlier that you were looking at rest of the world outside Europe and Us in terms of market research. What are your what's your strategy today or Thursday out licensing is are you having discussions already or is that something that comes when you're after feed-through data available?

Yeah, so I think we're excited about the potential of eau de VIXX bad outside the US and Europe. That's where we focused as we've done more research and that you know, we find there are a lot of countries particularly genetic perspective where there are clusters for for which is very interesting for us and for biliary atresia as well. So we continue to have good dialogue with potential potential partners are intent to have used to have a a small focused commercial organization in the US and in Europe in those countries where we don't have as much expertise is to engage partners and those discussions are ongoing

Great. Thanks for the update. Thank you Alan.

Our next question is from Matt Kaplan with ladenburg thalmann, please proceed. Hi. Good morning guys. Thanks for taking the questions. Just want to focus in on your commercial preparation for the effect one after after after the read out. What are what are your thoughts on reimbursement and specifically what will the commercial team look like at lunch?

Great. Thanks to the question that fellow that's right down the middle for you. So why don't you answer that question, please please sorr. Hi Matt. Thanks for the question, As we are thinking about relation. Our our preparation is really in three areas. You know, we're looking across Market access reimbursement as as you suggested also a physician engagement and patient advocacy efforts. It's hard towards reimbursement. We've we've done a lot of work. We're really excited about where we are. We spoke with payers across Europe and in the US and have begun to educate them about the disease and when we do educate them about the disease about peace, I can particular, you know right away. They see the severity of the high unmet need the lack of available options and you know, they acknowledge the risk of losing small budget impact dead.

So we have gone forward and creating our cost-effectiveness and other economic models or Value Story and generating evidence that will need that. We know the parents want to see if we you know prepare the economic. Is that they will need over all that with with with with access as well as positions and with patience and in terms of what the commercial team will look like at lunch which what's your vision there? Well, you know, we're really excited about this opportunity that the because that's been has been mentioned. The small focused prescriber based is going to allow us to have a very concentrated effort, you know, we envision 5225 field deployed individuals in the US and about the same amount in Europe. So a very focused and Nimble team

You know, the nice thing Matt is you know, we estimate that there are about a hundred key pediatric hepatologists in the US and Europe, right? So we don't have to go to many. We actually many of those individuals may be involved in all three of our pivotal trials. We were already developing strong relationships, you know with them and you know to Pamela's, you know comments about access. You know, remember that Pam has a lot of experience goes in access to have some kind of global pricing and access in a previous role and launched products, you know, successfully, so I think I feel pretty comfortable in are ready from an access perspective.

Right great. Thanks a detail then one question on.

Allergy whole pivotal study. Can you give us a sense in terms of now with your your thinking and the feedback from the FDA and the design what your what your price is timeline is that studying you mentioned that you know would fall between the readouts from the pet pick one study and the Bold study and and twenty twenty four. What's what can you kind of fine tune that out for us? Yeah, give us a little time to put the bowl on on the study and we'll give you more details in that regards. But you know as we're thinking right now, we plan to be ready, you know by the end of the end of the year and as I stated this study will look more like the studies for the size and length result. We'd expect them to come in between the top-line results with the pet fix study and and the Bold study were all I think just reiterates our our commitment to building. Oh to fix bad into major major drug for Pediatric cholestatic liver disease dead.

speaks to the large commercial opportunity

Okay fair enough and look forward to edit detail. Thanks. Thank you for calling Browning.

Our next question is from Pharrell with Calvin and Company. Please proceed.

Hi guys. Thanks for taking the question. Have you publicly stated what the last station last visit in the pets of one trial will be and can you walk us through any require safety follow-up? And how how are you looking at cleaning up the data in the age of covid-19 heard from other companies that you can't visit the sites off of go through the records and Hunt people down over, you know, weird chart comments or whatever. So, how are you thinking about all of that? And then I have a follow-up. So let me start and then I'll hand it over to Pat to perhaps give a little bit of color as well when guidance perspective. We announced in our our Q4 earnings off at the trial was fully enrolled. We'd previously announced that we were at fifty nine patients around the end of of January and a few more to go that kind of gives you a cell phone number.

So, you know what the last page should you know, looks like you want to talk a little bit about safety follow-up and can how we're thinking about collecting the data.

Yeah, so so yeah, this is Pat. So as you recall then patience in the Pentagon study are eligible to enroll into the study. So once they're done with the pets, like one study there really is no further follow-up. They go directly into the study. So last patient last visit is is is just a that is not an extended safety follow-up. In particular. I think in terms of getting on site and monitoring remotely. I think that's something we're very actively pursuing and I think the Regulatory Agencies have come out with a number of guidance actually surprisingly quickly to to help with that. So there are ways to do remote monitoring some sites have the ability to redact the patient information send that out. We're actually one of the things that people are exploring now is actually having for example a webcam at the site or someone from the site actually shows the monitor the source.

data, and this sort

And the monitor can actually Source data verify looking at the real Source data, but looking at it remotely go obviously all of these things are under consideration. All of these are being actively pursued and put in place our hope he is that we will be able to get people on site because that obviously is what everyone's used to in that will be the quickest but but there are workarounds and we're actually exploring all of those I think in terms of getting getting hold of people I think, you know with kind of with teams with all the different remotes. It's very easy to access the people in the at the office investigative sites and interact with them and you know, there's the talk about how busy the hospitals are and that's exactly true. But that's only true in certain parts of the hospital. So for example, the research staff at a number of hospitals actually have relatively more time now to work on active studies because you know, there are some of the observational Studies have been dead.

Continued whereas the Interventional studies especially the phase three studies are allowed to go on. So so we have found that helpful actually not only in Penticton in their action there, but even in some of the start up with it. Let's go here is Tricia that the the sites have more time to dedicate that. So again, I think like everybody else were learning as we go but we see potential grounds for all of these and I think just Add 3 2 and thanks Pat. We're in pretty good shape. So remember that, you know, we have more than three-quarters of the patient through the pets like one study and so we've we've collected a fair chunk of data and have done some, you know, good chunk of data cleaning already has Pat says, you know, there's work to be done. But I think we're planning on some some reasonable workarounds and we're hopeful of the ability to get to the sites as well in a reasonable time frame.

That's that's great to hear. I mean, I can barely get grocery delivery here and sealed. So get to see you guys are on top of it. What about pets to data released at the same time? It's hectic one off line. Will we get anything?

Okay, why don't you address that so so the answer to your question, we haven't had that internal discussion yet. The plan is, we will do an interim cut of the pet pig to data and that will be included as part of the regulatory submission when we do it. So we will analyze the interim cup and month and include that what we we haven't to answer your question directly. We haven't had any kind of internal discussion about when and if we would do a press release on that data or whether we would save it for a scientific meeting or or what we would do with that. It is clearly doesn't have the I mean it's supportive data. It is important but it doesn't doesn't have the same importance level as the pet tick one study.

Got it and last question. Why is he a farmer?

Paying a higher higher National. Why are they more interested in? Why didn't you elect to do it as far as opposed to you know, thank you for life question. Me too. I think it's just about our overall. I just learn as much as possible and and to you know to share costs right? So I think we're looking for jobs. And in this NAFA space is is a signal of some sort. And we're looking to is as well in improvements of liver disease is cardiovascular risk add the GI tolerability part of it. And you do know that with these I bet Inhibitors that you go to higher doses by definition, you're going to induce diarrhea. So we believe by pulling resource Pharma and and and and us being focused on a five milligram arm versus placebo. Where am I?

10:00 and tell middle ground with with cholestyramine cholestyramine on its own and Placebo the totality of that data will give us a signal and that will give us sufficient in information to inform the next stage development.

Is there a study being run in Japan it is being run in Japan.

Got it. Okay. Great. Thanks for taking the questions.

Thank you Ritu.

Our next question is from Jim Legion with William Blair. Please proceed.

Thank you for taking the question and congratulations to a team as everyone continues to manage to a difficult environment allergy syndrome mentioned the trial that you're discussing with. The agency would be more similar to pick one than bold. I assume that's a comment based more on endpoint from design. And can you just maybe that's why you would not use an randomize withdrawal type of trial design similar to put some others have been successful with

Yeah that thank you and thanks for joining us that comment is more round to give you more about about size and length more than anything else, you know, as you know, the biliary atresia study is larger, you know, it's 200 patients. Right and it'll be longer. It's a two year. So take your comments to help you sort of took the size and length of the study more like the pathetic ones being as they said, you know will provide you more details once we put a bow on this.

Understood thank you for that and filing if I can pick one and it's just isn't cool commentary, you know, we all kind of understand to write us and its indication very often here. But now that you fully randomize the trial before the completed so you just give us a sense of the Baseline. S scores with Precision a patient-centered the trial where they all three and fours whether any to

Yes.

So thanks for the question me. I think we're not prepared to give the details on the Baseline as yet to suffice to say the entry criteria says you do you have the base line of two or org? Okay understood and can you just maybe update us as well on the rollover frame Pizza one in the two. I think last quarter. You mentioned those almost all the patience. Is that computers do the key?

We have not provided any guidance in regards to the number of patients that have rolled over as yet. All we've said is that that Victor has an attractive study off and then we now have patients that have been on drug for well over a year.

Thank you very much. And congratulations again. Thanks for joining us then.

We have reached the end of our conference and it sorry question and answers. I should I would like to turn the call back over to Ron Cooper for closing remarks. All right, thank you operator and thank everybody for tuning in today. Today's conference. I think you find or an exciting and and and pivotal time. You know, I think we all know that covid-19 on everyone's a mind and it does make things more difficult, but regardless of the challenges of covid-19. We as a company are on track we expect to to to deliver data for and the pet book one study and data for in the study mid this year. And I'm also very proud of our organization in that we are building or to fix a bad into a pediatric cholestatic liver disease drug by getting the volt study, you know up and going we also have an organization. Uh,

That is growing and we have the financial resources to accomplish all of our objectives. So look forward to a strong back half of twenty-twenty. Thanks again for joining us.

Thank you. This concludes today's conference. You may disconnect your lines at this time, and thank you for your participation.