Q2 2020 Cara Therapeutics Inc Earnings Call
Ladies and gentlemen, todays conference is scheduled to begin shortly please continue to standby. Thank you for your patience.
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Good afternoon, and welcome to Cara Therapeutics second quarter 2020 financial results Conference call. All participants are now in listen only mode. They will be a question and answer session at the end.
Please be advised that this call is being recorded a karen's request I would now like to turn the call over to the care team. Please proceed.
Good afternoon. This is Jack he'll take Smith with Stern Investor Relations and welcome to care Therapeutics second quarter 2020 financial results and update conference call.
The news release became available just after four P.M. today can be found on our website at www Dot Cara Therapeutics Dot com.
You May also listen to a live webcast and replay of today's call on the Investor section of the website.
Before we begin now let me remind you that statements made on today's call regarding matters that are not historical facts are forward looking statements within the meaning the private Securities Litigation Reform Act 1995.
Examples of these forward looking statements include statements concerning the expected timing of the data readouts from the company's ongoing clinical trials the potential results of ongoing clinical trial tiny a future regulatory involvement milestones the company's product candidates, including the company's projected timeline for this.
Admission of its first and yet.
Potential for the company's productivity to be alternatives in the therapeutic areas investigated and the company's expected cash reach.
Because such statements are subject to risks and uncertainties actual results may differ materially from those expressed or implied by such forward looking statements.
Risks are described more fully in care therapeutics filings with the Securities and Exchange Commission, including the risk factor section that companies. Most recently filed quarterly report on form 10-Q, and its other documents subsequently filed with or furnished to the securities and Exchange Commission.
All forward looking statements made in today's call speak only as of the day on which they were me care Therapeutics undertakes no obligation to update such statements reflect events that occur or circumstances that exist. After the date, which they were made.
Participating on today's call, our Dr., Derek Chalmers care, President and CEO and Mr., breaking the Kara VP and head of accounting on I'll turn the call over to Dr. Chalmers.
Thank you Jack good afternoon, everybody and thanks for joining in on this afternoon.
So in the second quarter, we have made significant advancements and our development programs for both crude to the injection and oral pursue though across a range of comedy indications.
In April we were pleased to report positive top line data from the time to trial, our second pivotal phase three trial of crude to the injection for chronic kidney disease associated <unk> D P and hemo dialysis patients.
The robust anti Pruritic ethic, you'll see a pursue the injection in this study was consistent with the object in our first piece, we have one trial and we remain on track to submit or in the fourth quarter.
Sure.
We're also making good progress in advancing the development of or pursuing across a number of patient populations will provide his continues to be a significant unmet need.
Recently.
In Q2, we completed a planned interim statistical analysis of our he or she used to dose ranging trial.
Oh pursue that for the treatment of moderate to severe crew I just didn't he told me dermatitis patients.
The sample size adjustment post analysis, so approximately 28% with 11 is to maintain the pre specified desire statistical powering of that study and we project to complete enrollment and the fourth quarter. This year.
Due to the ongoing Cobiz 19 can damage and in accordance with yesterday's updated guidance for conducting clinical trials, we have implemented numerous clinical and operational measures to prioritize the health and safety of patients.
Our employees and study investigators and minimize potential disruptions to our ongoing clinical studies.
Although we experienced on cold winter related closure or certain clinical sites for ongoing phase two study in Q2.
Due to the entire carrot teams continued dedication and very hard work. We've now completed all clinical trials and caused all databases for Andy So mentioned and we continue to enroll patients across ongoing or we'll pursue my trials.
Now, let me share no. We do know each of our ongoing programs starting with our lead program for creative injection and hemo dialysis patients. So as a reminder, the patient population where across only 40% to 50% of patient some folks from moderate to severe provide us her the national kidney Foundation there over.
500000 patients on dialysis and the U.S. and approximately 60% experienced some form of providers.
Right just can severely worsen patients quality of life, including sleep disturbances depression anxiety and.
And it's also associated with increased morbidity and mortality and superior patients.
There is still significant unmet need with no therapies currently approved in the U.S. or Europe. So we believe creative injection has significant potential to change the treatment paradigm with these specific patients.
Our pivotal program includes four phase three studies can want a U.S. efficacy trial, which we had a positive top line data last year come to a global efficacy trial, which would have cost of top line data in April of this year and to open label safety trial.
Both Cam won and come to were designed to investigate the efficacy of pursue the injection that adores, a <unk> 0.5 micrograms per kilo versus placebo administered three times per week after schedule dialysis sessions over a 12 week treatment period.
Both phase three trials achieved statistical significance on both the primary on key secondary endpoints and then for pivotal creative and you actually was generally well tolerated with a safety profile consistent with prior clinical trials.
Oh safety data bases for phase three program are not closed with total safety exposures and exacerbate huge guidelines to support the Andy submission with more than 1500 total patient exposure is achieved including more than 700 patients completing at least six month opens up country.
When you is treatment and greater than 400 patients completing one year of treatment.
Our focus now like I was on preparing Iran package for submission to the FDA and next quarter.
[noise] point, we will also be applying for a priority review status as of course cursive injection has breakthrough therapy designation for this indication.
Pending approval, we're planning for consumer injection commercial launch in the U.S. as early as next year and we're focused on executing a cross functional plan to ensure a commercial preparedness.
We already established and National MSL group account rounded being innovative and working hard even in the present covenant environment and playing virtual format symposia and engaging.
Cana wells electronically and an effort to increase awareness of CK VIP through disease education.
We've also established a commercial manufacturing agreement progressive injection, and we've begun to sell senior positions and sales and marketing.
Outside of the U.S., we've established commercial license agreements another major commercial markets, including the easier to calm in South Korea and that he used our agreement with the four Fresenius allows us to leverage for the nephrology focused expertise at the before Salesforce and Fresenius is broadly.
Each to dialysis patients across Europe.
For Fresenius or planning to submit for marketing authorization approval to the economy. Shortly after we complete the N D submission next quarter.
We're very pleased with a consistent robust results across our account peace Sweet program and we're not focused on finalizing or indeed, indeed package for submission and the coming quarter and of course, we're going to continue to update you on a commercial strategy as we approach not filing.
I'd also like to reach.
On a pipeline programs focused on formal pursue the across a range of Trinity Perednik patient populations.
So starting with our lead program and pre dialysis CKD patients with moderate to severe provide us.
Right as conditions that affects a significant number of pre dialysis patients out of approximately 7.5 million people diagnosed with CKD and the U.S., we know about 33% receive some sort of treatment for provide us the so us approximately 2.5.
And patient prescriptions based treatments are typically generic anti has the means or according to see rise neither of which effectively alleviate that provide a sport and long term for these patients.
In December last year, we reported positive topline results from our 12 week phase two trial evaluating the safety and efficacy or three tablet strengths of oral pursue the 0.25 0.5 and one milligram once daily.
Based on that data, we identified the one make tablet strengths of oral pursue the as the dose level to take forward into phase three.
So given all cursive as potential invest patient population were eager to Minto registration program as soon as we can add to that and we plan to launch the safety portion of the pivotal phase three program and secret the piano fourth quarter of this year.
I have to apply on indices to meeting with the FDA, which we could get to take place and the first quarter of 2021.
We're also currently about meeting for creative and ongoing phase two trials for each helping dermatitis already and primary biliary cholangitis or PPC.
And as many of you know horse is one of the most common chronic inflammatory diseases.
We have lunch rates up to 5% adults and approximately 25% in children.
Right as the defining symptom or the topic dermatitis with the point prevalence estimates estimated that almost 100%.
A majority of patients around 80% or in the mild to moderate mythology category, where biologics are not indicated and current treatments consisting of topical corticosteroids hydro's antihistamines onto depressants simply 12 short for these patients for Thats condition.
So we believe workers.
And you could be a first in class anti pruritic caught up with favorable safety profile for patients with a topic dermatitis.
Our ongoing he or phase two dose ranging trial was designed to randomize patients across three tablet strengths 0.25, 0.5 on one milligram, taking twice daily versus placebo.
In June we completed a planned interim conditional power assessment conducted after approximately 60% of the original targeted patient number completed the designated 12 week treatment period.
Based on the independent data monitoring committee to recommendation, we increased the trial size from 320 patients to 410.
This increase allows us to maintain the pre specified statistical power of 80% or greater on the trials primary Mena and our S change endpoint from baseline and the key secondary greater than four point responder and point, which is the excepted clinically meaningful.
And point for regulatory approval of Therapeutics Cooper correctly dermatological indications with additional clinical sites added in Q2, we expect to have this trial fully enrolled in the fourth quarter for this year.
We are also enrolling patients in our ongoing people see phase two trial of workers and PBC patients with moderate to severe provide us.
Right as is common symptom of call a static liver diseases with 20% to 30% of patients experience and provide us with the prevalence of up to 70% and patients with PBC.
16 week trial is designed to evaluate the safety and efficacy of one make top of oral pursue the chicken twice daily versus placebo and approximately 60 patients. The primary endpoint give us a change from baseline and the weekly meeting of the daily 24 hour West niche and Orient score at week 16.
Similar to the study, where it's finding clinical sites, where we can however, due in part to cope with 19 impact. We now anticipate reporting topline data from best people with CF study and the first half of 2021.
So overall, we're pleased with the progress made across all of our development programs in the second quarter, particularly in the present environment and we're looking forward to achieving significant regulatory and clinical milestones through the end of this year and into 2021.
So what that I now turn the call over to Greg to cover the financial results for the second quarter Rick.
Thank you there as a reminder, full financial results for the second quarter of 2020 can be found in our press release issued today. After the merger closed for the second quarter 2020, we reported a net loss of $25.1 billion.54 per basic and diluted share.
Compared with net loss of $23 million or 68 cents per basic and diluted share for the same quarter of 2019.
The second quarter 2020.
Second as revenue of $4.5 million believes the before persons license agreement compared to $5.2 million. During the same quarter in 20 like team also in the second quarter of 2020 recognized approximately $600000 of license and milestone revenue.
Related to milestone payment received from CKD pharmaceutical Corp. Additionally, we recognize approximately $500000.
Clinical compound revenue the sales of clinical compound in the second quarter of 20 to 22 million you. She in before there were no sales of clinical compound or milestone revenue for the three months ended June Thirtyth 2019.
The second quarter 2020, we reported R&D expense of $26.1 million compared to $24.4 million in the same period of 2019.
Or higher R&D expense in 2020 were primarily due to increases in stock based compensation expense payroll and related costs and cost of clinical telephone sales, partially offset by decrease in clinical trial costs conferences and travel and related costs.
DNA expenses were $5.4 million during the second quarter 2020, compared to 5 million in the same period of 2018.
The increase in 2020 was primarily due to increases in consultants costs legal fees insurance costs, partially offset by a decrease in stock based compensation expense.
Other income was approximately $600000 in the second quarter of 2020 compared to approximately $900000. In the same period of 2019 decrease is due to lower interest income on our investments in marketable securities.
As of June Thirtyth, 2020, or cash cash equivalents in marketable securities totaled $153 million compared to $218.2 million as of December 31st 2019 decrease primarily primarily resulted from cash used in operations slightly offset by proceeds from the exercise of stock options.
Turning to our financial guidance based on projected costs were a clinical development plans. We expect that are cash cash equivalents in marketable securities as of June Thirtyth 2020 will be sufficient to fund or operations into the second half 2021, not accounting for any potential milestone payments under existing collaborations.
Now I'll turn call back over to the operator for today.
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[noise] Jimmy.
I pick up on the couponing.
Great.
Jack can use direct MCU and eight from your line.
Hi.
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Okay.
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Apologies for the way.
Now for the QNX session, if you'd like to ask a question. During this time. Please press Star then one on your touched on telephone to withdraw your question from the Q. Please press the pound key please stand by what we compile the Q and a roster.
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Our first question comes from Chris Howerton with Jefferies. Your line is now open.
Great.
Thanks for taking the questions I appreciate it so I guess.
First just kind of thinking about financials moving forward.
How should we expect the DNA line to change kind of going into.
Potential approval in India submission and obviously commercial preparations.
As a corollary to that.
What have you disclosed about potential milestones for approval with your agreement with.
After as any is and then the third question continues.
I'm not sure if we discussed since in the past Jack and I apologize.
Just for getting but with respect to the sample size read adjustment for the topic and taste trail.
What specifically do you think was different in terms of your initial powering assumptions versus what you actually observed within the trial. Thanks again.
Yes, Hi, Chris I was I was expertly Don to get three questions in there.
Olympic start with that.
Let me start on the on the financials and the.
Milestone related question. So so we've talked about this before and that certainly other and publicly available this $30 million and approval milestones associated with the V for Fresenius agreement and does Rick highlighted again of course, those are not incorporated into our runway projection based.
On on current finances.
What is incorporated in there and gems that runway projection as.
Projected commercial costs.
Course, MSL costs going through and to 2021. So those are already in there I mean, we don't as you know gate quarter to quarter on changes in particular.
Financial subgroups, but what I can tell you as a majority of that commercial cost is going to be incurred at approval.
So all of that budgeting isn't there Chris all the way up to approval and we wouldn't fully activated so salesforce until we have.
Label approval.
Under the age I'd say on on the sample size adjustment here it was.
You are not.
It's a new classification, if you like as you know weve.
Dominantly been generating data CKD associated Pruritis unnecessary first patient group, we could categorizes dermatological.
Dermatological inflammatory am so so we made some assumptions based on a sample size, but of course, we made them from a different.
Patient category in CKD so.
The sample size increase here was not to the unexpected as one of the reasons as you know we employ this strategy and basically all of our large clinical trials to mitigate the rest of a new mass here.
So so the other aspect to that sample size re estimation as.
For the first time, we've looked at two endpoints simultaneously.
One of which of course is the regulatory approval and putting us at four point responder. So that's the higher threshold if you like.
Endpoint. So so in looking at both of those as perhaps not surprising that we see a slight adjustment in sample size than we should say.
We ended the DFS ends up being $1 versus placebo sample size adjustment, we're still at a sample size of that will be approximately 125 per group, which is less than that weve used in our phase three studies in CKD associated Paradis. So we think that augurs well in terms of the size of.
Of that affect it remains to be cut back to Tom and of course, when we get.
The top line data, but that sample size adjustment is inline with what we do expect.
For patient reported outcome, such as such as providers.
Right, yes, okay and.
What was the so there was what was the maximum size that you could have increased two was more than you did right.
Yes, yes.
Could have gone up.
You know much higher.
I think.
Sure total patient population could have been close to 500.
Trial, so so so we definitely.
Didn't get the maximum upsizing advice from the I'd Idmc.
Okay.
Very good well, thank you for taking the questions and I think in Q.
Thanks, Chris Thanks for dialing in.
Thank you and our next question comes from David Amsellem with Piper Sandler airline is now open.
Thanks, So just a couple first.
Eric can you just give us your updated thoughts on.
Pricing for.
Ivy courses.
And maybe help us in your thought process regarding what.
Analogs competitors et cetera.
Oh might make sense here.
So that's number one.
And then secondly at a question about the.
PDC program, so to the except that you do show proof of concept in that program do you expect that a pivotal study would.
Factor in a wider.
Population of liver disease patients or do you expect that the FDA will have you remain on the.
The narrower PBC pathway.
Terms of indication thanks.
Thanks, David those are those are good question. So so I think we've had this can a general discussion before her on the pricing.
Analysts if you like for cursive injection of course that remains to be determined. It's still very early you know we certainly didn't have a label first about before we get to the details of that.
I think upset in the path I think there's some.
Relevant compile it or is there.
You know versus if you like serious symptom treatment tight drug and it may be analogous to something like a highly differentiated pain drug in terms of price point of course, it's going to be part of the to DARPA system related to the SRT bundle payment and they are.
We don't really have a law as you're well aware a lot of examples the Luca and terms of available price point, whereas one drug that's run through the to Dr. system, and that's amgen's per se, but.
Which is about to end this the doctor period this year.
That drug priced in the high teens, approximately 17000 annually and as you're well aware of course that was really.
Intravenous formulation of the other calcimimetic for which there are other.
Alternatives available so so that might be one price point, there's certainly been out there and being paid by CMS interestingly enough in the latest update to the yesterday bundle legislation, which was published in July.
Yeah, Matt as people other than to provide additional monies.
I would pay for perceive the post to DARPA and if you work that based on that occur.
Session increase and.
Reimbursement there it looks like it's approximately 800 million.
Annually, so that is getting years and the first thing we've actually seen some data related to where CMS may go and post the data.
Funding, but I think we said an asset somewhere between.
Highly differentiated pin type drug and maybe a novel.
Drug with some premium related to being a first in class breakthrough medication those would be kind of the bookends on that and then.
Myth and onto the.
PB see studies here, so you know.
The way, we look at the oral tresiba potential here is that we're certainly interested in pursuing registration programs for per CKD pre dialysis program.
Patients rather.
And certainly for a topic dermatitis should we see the hope for positive top line data out there.
In terms of.
PBC and other liver disease associated Paradis, that's the.
That's an area, where we're generating data that we hope is gonna be supportive.
To getting a general label ultimately on that or formulation that may not be a program we run into registration as rapidly as those two other.
Programs, However, having said that as you're well whether it's on large number.
Liver disease patients, we provide us as a significant issues there might be something we revisit down the line, but we were designed that original trial, it's really to obtain the data.
To support the idea that we have a mechanism, which you know should be broadly applicable.
Across patient populations and support that discussion we aim to have with the FDA down the line that really or pursue the.
Should justify a broad onto critic label.
Across patient populations.
Okay. That's helpful.
Thanks, Dan that's great. Thanks.
Thank you. Our next question comes from Annabel Samimy with Stifel. Your line is now open.
Hi, Thanks for taking my question.
So I see that you're not going to have the the three.
Phase three I'm sorry.
The first phase two meeting with with ethane so that the phase three program for pre dialysis until first quarter 21, but youre.
And again going to start your safety study. So can you just described.
What exactly do they think the safety study is going into held for the specific program and how much you're going to be able to draw from Ivy and as a second question when it comes to.
The discussions with FDA with regard to.
The endpoint that you're looking at can you just confirmed.
For I'd courses that those are at that secondary endpoint are not regulatory endpoints that rather.
You characterize clinical benefit for the label I'm more FDA be looking at those on a pool basis.
Would it be presenting them on a pool basis on any color there would be great. Thank you.
Thanks, Annabel so again, so the interface to meeting for oil pursue that we will be requesting not meeting next quarter, but you know there's a timeline.
Proceeded with getting that scheduling from from the FDA. So we do expect that to happen.
Most likely in Q1, so so in order to get ahead of that timeline, if you like to get that NDS submission when we want to get that Andy a submission.
Clearly one of the bottlenecks and these programs is the one year exposure data.
So so our plan is to start that open label safety trial as quickly as we can next quarter. Even ahead of that meeting, where we really don't need any destination or further feedback on endpoints right. We're looking for safety exposures and the appropriate patient population. So that's the idea that sequencing get ahead of the timeline started.
Long term exposures early and then clarify what we need to clarify with the asked yet at the subsequent meetings. We also wanted to make sure CMC reviews, an important component to that end of phase two meeting and that timeline alliances to ensure that we have completed essentially only analytical specification with.
As we need to the phase three standards to make sure. We can have a successful and to phase two meetings, so thats part of that.
Timeline.
As well.
And what was your other question Oh, yes, so the other the other part of that of course, yes is that we already essentially half safety exposures from our hemo dialysis patient population. So obviously that will be part of our end of phase two discussion as to use in those patients as part of our overall exposure in on.
Since essentially we'll look at the end stage versus versus earlier stage. So the oral cursive a program so that will be part of the discussion.
Theoretically have certainly being the case with others.
You know applications, where where there's a change in formulation, but within the same patient population at maybe possible that we could conduct registration program with one.
Pivotal trials, not certain agreements and an item for discussion with the FDA, but certainly something we think is possible. One we're raising based on the precedent we see yet there are from other from other previous program so that will be.
I will be something we'll be looking and then your final question.
Bill was on endpoints for the oral.
Yes.
Yes, yes, so Dan.
Oral.
As you know we conducted our.
Our phase two trial, a dose ranging trial using our most sensitive and parents to think that.
Optimum dose and Thats. It continues endpoint and our asked measuring itch difference from baseline included for secondary there, which was three point responder, which you know in this patient population, we defined by psychometric analysis is.
As the level for clinical meaningfulness for CKD patients experience and moderate to severe credits that that will be the proposed registration and point to three point responder endpoint for the world.
Okay, sorry, I actually meant for FERC come to you, but let me just cut that aside from and I just wanted to follow up I sat for the safety studies for the pre dialysis population given that hemo dialysis patients are essentially the drug is essentially cleared for them do you think there might be any.
Dear friend.
Metrics that they're looking at in this reality is population given given they have compromise that kidney function.
No we've run that Teekay analysis, and some detail across each of these pre defined.
Pre dialysis stages for CKD, we know precisely how its excrete it and these various stages, hence the once daily administration suffices for CKD pre dialysis patients, whereas and as you know just to reiterate revenue one who couldn't who is regarding here of course could serve as the screen almost exclusively.
Via the kidney.
Whereas when we move away from these you know.
Dialysis and pre dialysis CKD patients to normal if you like kidney functioning.
Patients such as any toss it we are those in paradigm to be I'd. So they get a drug twice daily so we have that modeled.
Across the various populations and we know exactly have as habits excrete. It we know what it takes to get to steady state and each of those populations and that helped define the doors Empire. Dan you see in these various phase two phase two studies.
Okay got it thank you.
Thanks Annabel.
Thank you. Our next question comes from Jason Gerberry with Bank of America airline is now open.
Hey, good evening and thanks for taking my questions.
Derek can you talk a little bit about how are you think about but pivot to going commercial next year in terms of when you'll start to.
Encouraging them to commercialize it commercialization costs versus bringing folks on a contingency basis would you expect we really won't start to see that spend incurred and so it of course. It was approved and then you know I appreciate the commentary on the cash runway can you talk about are there any alternative financing.
Measures on the table mindful that your next sort of natural catalyst would presumably be the phase 280 data. So just sort of wondering how you're sort of thinking about managing some of these puts and takes in terms of the capital our runway. Thanks.
Yep, Thanks, Jason Thanks for those questions.
You know in terms of preparations precommercial activities, there has been under wafer for quite some time.
The company so we've established our and actually we're expanding our national MSL team.
Who are working to broaden our care, while universe increase awareness of CK DLP it'd be in establishing regional national advisory boards.
You know the usual sponsoring a strategic education opportunities.
Including CMD symposium at the appropriate meetings and actually.
Grips adopted well to the current environment and those have been virtual essentially since Q2, and we've been increase in our publication footprint to support you know dissemination of information out there for who nephrologist. So so all that's been underway.
For quite some time.
We didn't back into early last year. We've also established our commercial manufacturing capabilities with our CMO and that's in place and ready to roll and we recently completed our first senior commercial higher so we're not moving down into the larger.
Number two required for Salesforce as I said earlier until we get all the way to approve on us, but we're filling in the senior management positions and all that's included in the projections that we've talked about today, we've initiated you know licensing.
Allocations for all of the space, we already have equivalency today, and we continue with these cross functional plans to make sure we're ready for launch, but you know the biggest uptake in terms of band and not commercial push comes with the introduction of the Salesforce and as I said earlier that.
I'm not going to come until approval. So that's a 2021 event so until that point. This is a relatively modest.
And you're going to see here going forward given to 2021 in terms of financing as you know we've been.
I think quite opportunistic and go into the capital markets.
Usually it's been a catalyst driven.
Follow on offerings, where we see a response and our and our valuation and we've gone to the capital markets for that we have a good balance sheet at the minute going forward, but we're always looking for opportunities Jason.
And if it's appropriate and is an agreement and propel as to where we need to be across our various programs.
Other involved in that territory.
Or with a new partner, perhaps where appropriate we are certainly looking at those opportunities. So we're open to those.
Possibilities there and we're just on a you know look for the most.
Valuable.
Mechanism and means can make sure we have the appropriate balance sheet. When this when a stroke is up for launching.
Okay, I can I squeeze a follow up in the mechanics of getting year to DAP add on payment status.
How much time kind of post approval do you think.
And to what extent you might think there could be a lag factor in terms of getting your today.
And if that's a approved.
Yes that is relatively quick but should add it could be a case of a quarter.
In terms of extra timeline may be necessary to make sure we have that.
You know all tied up and ready to go.
So that your tenant dashed an additional period.
Okay. Thanks.
Thanks, Jason.
Thank you. Our next question comes from Alan Carr with Needham and company. Your line is now open.
Hi, Thanks for taking my questions.
Kills but more about the safety trial, they will say travelers, who can you give a sense of the size of that.
And then actually can you also elaborate a bit on.
Well its gating for that.
[noise] interface to meeting.
For the oil formulation CKD.
Thank you.
Great. Thanks, Alan Let me take the second one first is I think at kind of mentioned doesn't.
In response to David.
Of course, Enphase do we want to clarify our clinical plan make sure that the EPS to use an agreement with endpoints and design and so on the bank part of that meaning of course, the CMC related.
And at this point, we want to make sure we have appropriate analytical tools.
Specifications analysis for our oral formulation that meet phase three.
Sure commercial a level so that's what we're.
Running through it the minute that's really the gating factor in that as we have to manufacturing scale for those and that whole process has been transferred from our biotech partner, which is entrust over to our CMO. So that process is well underway, but that is important but we have that complete prior to the meeting so that.
That's the main element, we need to get and that fits in nicely with the timeline of indicated here. We're fine for the indices to next quarter based on the schedule in timeline, we know what the FDA, we should have everything complete and tanks with that for that Q1.
And to see to meeting and then on your first question.
I wish add more detail to tell you that something thats underway in our clinical team in terms of the design about open label safety trial is likely to be a couple of hundred 230 patients I would imagine to make sure we can get.
The numbers, where the need to be for that long term exposure, there and considering potential dropout rates, but I don't you know there is no final.
Design element ready for me to really at this point, but we'll certainly disclose that when we started the study.
Okay. Thanks for taking my questions.
Thanks Al.
Thank you and as a reminder to ask a question you will need to press Star then one on your touched on telephone.
Sorry question from the Q. Please press the pound cake. Our next question comes from Ben Shim with Canaccord. Your line is now open.
Hi, Thanks for taking my questions.
Derek.
For a topic dermatitis and deliver how often are being enrolled patients physically checking into the clinic and.
Are you seeing a difference in enrollment has to come to your pace between the two.
Ralph.
And then my second question along lines of new hires.
Can you update us on search for new CFO. Thanks.
Yes, thanks, and so so.
I mentioned best and the prepared remarks that we have seen some effects in terms of the corporate 19 environment on enrollment in both the 80 and the PBC related phase two for both of those.
Trials, there's been issues with opening up new.
New sites R&D, losing some sites and particularly end of Q1 into Q2, but for a D. We've actually seen that very nice rebound there in terms of enrollment rates and we have opened up a novel face in Q2.
Which have grew up additional patients to that trial, so that enrollment level and he has recovered very nicely almost decree code.
Oh, so that's gone rather well the PBC.
Enrollment has suffered from our inability to open some some ex us sites, which we know we're going to supply significant numbers of patients there and as you know that's an orphan indications there has been challenging.
Bring those that so so that has suffered a little bit and that we shouldn't open those sites additional sites due to the call with environment, thus improving that.
And we hope to at those later in the year, hence the guidance that we see that data.
Being delayed in terms of top line to the first half of 2021. So there has been some effect, but we're still seeing patients.
Enrolled.
Not sure indicates a V topic, we're seeing very healthy enrollment rates and really these patients come back to the classic really just to renew their tablets supply.
So so they come back I believe it's every two weeks.
To get that tablet supply and maybe take some clinical measurements at that point so.
So that's how that is design.
On the other question yet on the CFO front, we did have an activist search underway will be screening.
Candidates for quite awhile, and I hope to have some news so you're not front.
In the coming in the coming quarter.
Right. So very helpful. Thanks for taking my agenda.
Yes, we're dialing in.
Thank you and I'm showing no further questions in the queue at this time I like to turn the call back to Derek Chalmers for any closing remarks.
Alright, Thank you Jimmy and thank you everybody for participating in today's call I'd also like to thank the carotene, our study investigators and all of the patients to continue to participate in our clinical trials and we certainly look forward to updating you all again very very soon so stay safe see healthy and thank you very much for dialing.
Take care.
Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program and you may now disconnect.
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