Q1 2020 Earnings Call
Ladies and gentlemen, today's concentrate schedule to begin shortly please continue the standby I think you pay attention.
[music].
Ladies and gentlemen, thank you for standing by and welcome to the Chatting point Deputy Express quite a 2020 conference call at this time, all participants analysts and on the mat.
After the speaker presentation there'll be a question and answer session.
Ask a question during the session you when you touch star one on your telephone if you're quite any feathers just <unk> yeah.
Now they tend to compensate yes, we could today Jim Mazzolla. Please go ahead sorry.
Good afternoon, everyone. Following market closed today, we filed or form 10, Q. and issued a news release with the summary up my results for the first quarter of Twentytwenty. We also updated our investor presentation, you may find the docking.
Posted I mean Buster pages of T.P. therapeutics Dot com.
Leading the call today will be turning points, President and Chief Executive Officer Doctor <unk> Cool provide an overview an update on our business results, including our response to the Kobe 19 pandemic.
He and his remarks, we followed by review of our financial <unk>, We will take questions. Following our prepared remarks as a company. We are hearing to guidelines were social distancing and remote work and therefore, the three of US are in different locations. Today. We have previously recorded are prepared remarks, after which will host alive q. and eight.
Session. So please bear with us at this modified approach results in any technical issues.
Before theater begins I want to remind you that during this conference call, we will be making forward looking statements. The company's actual results may differ materially from those expressed in or indicated by such forward looking statements.
For description of risk factors associated with investing and turning point therapeutic.
Use refer to our weekly filings with the Securities and Exchange Commission now, let me turn the call call over to a thing though.
Thank you gentlemen, good afternoon to everyone joining us today before I begin I want you acknowledge how incredibly challenging past quarter why for so many in our society and especially thank each and everyone. After dedicated healthcare providers could've made so many sacrifices these past few months for the health and wellbeing.
<unk> patients worldwide.
Despite the challenges we have remained focused on our goals to bring meaningful therapies to patients can need while navigating the rapidly evolving situation with Kobe at 19.
Incredibly proud into progress our team made during the quarter inch we used to now provide an update on the quarter and our response to that pandemic.
For anyone knew to our story I turning point, we have internally discovered and developed are wholly owned pipeline of next generation tyrosine kind of thing hit bears the target numerous genetic drivers of cancer.
Today, we have four active development programs with the potential to address.
18% of the targeted therapy opportunity in advance non small cell lung cancer, if each of our drug candidates are utilized as single agents.
Starting with <unk> and specifically the Trident one piece to study in the first quarter. We remain pleased with the rate of global site Activations with approximately 50 per cent of our site now activated across 11 countries.
Includes the majority of our <unk> and key site in Europe, and Asia Pacific region.
These two portion of Trident, one is expected to enroll approximately 320 patients now it up to 120 sites globally.
In addition, we continue to anticipate providing early interim data from initial patients in some of the registration cohorts. During the second half of the year I will provide additional details for that update as I walk through our upcoming milestones.
We also recently completed our first independent data monitoring committee meeting for the Trident One study.
The D.M.T. is responsible for the oversight at the overall trial conduct and safety profile a brief attract you know within the phase two portion of the study.
<unk> recommendation based on the initial safety evaluation was for the study to continue.
While it is not our standard practice to get periodic updates <unk> in our ongoing registration trial I remain pleased with their progress we made during a very challenging first quarter. We took multiple steps to help mitigate the impact of the pandemic, which included remote site activation in data monitoring.
Labeling patience to have routine tests conducted closer to home and allowing site to evaluate certain patients remotely by phone or video conference.
These measures were implemented in collaboration with R.C. arrows are site and their I.R.B.
In addition, we have also evaluated additional sites for participation in our face to try to get one study.
Importantly, we have not experienced any covert 19 related supply interruptions to our clinical programs.
Despite the steps to mitigate the impact of classic 19, we have more recently started to experience delays and trial site initiation and patient enrollment within the Trident one study.
We are also closely watching the progress in our other studies and believe the extent of the impact on our pipeline will depend on the continued duration and severity of the pandemic.
Turning to our three earlier stage studies first we have an ongoing phase one to open label study to assess report truck in it in pediatric patients without end Trek for Ross one positive advanced solid tumors.
We continue to advance that steady with accusations inpatient enrollment.
Next is our phase one open label study F.T.P.X. 0022 are met C.S.F. One are in stark inhibitor in patients with advanced solid tumors harboring genetic alterations in met.
As a reminder of the study is a standard guess escalation designed to determine the maximum tolerated dos overall safety profile and preliminary S.P.C.F.T.P.X. 0022.
He said he hasn't ruled both she can naive and pretreated patients with primarily Exxon 14 alterations format amplification.
We anticipate recording early interim data from initial patients in the second half of 2020.
To help guide expectations, we anticipate this update will be primarily a safety update as well as any early efficacies signals as we continue through our gifts escalation cohorts.
Next in our pipeline is T.P.F. 0046, our rent <unk>. We are encouraged by the potential for T.P.X. 0046 based on its preclinical potency against wild type K.I.S.I.B. rat and solving front mutations, including G. 810 R.N.S.
For reference recent data published in the <unk> journalists harassing on college in a total of 11 rett positive patients treated with the red inhibitor sell per catnip indicated the rate of solving front mutations was approximately 45% or five of 11 patients.
While preliminary these data are consistent with the prevalence of solving front mutations observed in other oncogenic drivers, including Ross one track and now.
The dose escalation portion of our ongoing phase one to study of T.P.X. 0046, it's progressing with enrollment, including both she can achieve and pretreated patients and patience for solving front mutations previously treated with other investigational rat inhibitors.
The study is designed to enroll patience with red altered nonsmall, so long fibroid and other advanced cancers.
Lastly in our pipeline is T.T.X. 0131, our next generation Elk inhibitor candidate, we announced in January it's nomination enter I Indian neighboring studies with the goal submitting an I.D. by early 2021.
P.B.X. 0131 has been designed with a compact macrobiotic like structure and in pre clinical studies has been shown to potently inhibit wild type out and numerous out mutations in particular, the clinically observed g. One 202 are solving front mutation and she once you owe to our slash.
Well 1196 M. computation.
We are excited to advance destruct candidate as quickly as possible and have remained on track with preclinical activities during the pandemic.
From our programs, we have milestones anticipated during 2020 and I will now provided update of our progress towards each.
First as a reminder, we have guided trip providing early interim data from initial patients in some of their registration cohorts of the Trident on face to study during the second half of the year.
We are currently monitoring the overall study conduct and data collection to be in a position to potentially provide this update and the third quarter.
This time, we anticipate sharing seminary efficacy and safety data as it relates to overall responses likely by physician assessments in approximately 30 to 40 patients across multiple phase two cohorts, including our registrational and exploratory cohorts.
This will allow us to potentially evaluate data set at our phase two jokes in our global phase to study that is comparable in size to our phase one Ross one positive test to see a valuable population.
Monitoring this very closely and our goal given the uncertainty of medical conferences would be to provide this update with a news release and subsequent call.
As I said earlier for the T.P.X. 0022 data update we anticipate the initial update will focus primarily on safety as well as any early advocacy signals as we progress through our guests escalation cohorts.
Moving to our next step coming milestone and we were pleased to have several abstract accepted for presentation at the ASKO, an A.C.R. virtual annual meetings, our ask a poster will be a preclinical update for T.P.X. 0046 scheduled for presentation on may 29th with abstracts plan for release Tomorrow.
<unk> by ASKO.
For A.C.R., we will present preclinical reap attractive combination data and preclinical data for T.P.X. 0131.
We can now confirmed the fees poster presentations will be shared in late June at the second A.T.R. virtual meeting.
See our plans to release abstracts for the presentations later this week, which should indicate the date and time of our presentation.
The preclinical data for T.P.F. 0131 is part of our ongoing work towards our goal I mean I into submission by early 2021.
Now, let me turn the call already for an update on our financial results.
Thank you.
You will see in our press release financial tables that operating expenses for the first quarter or 62.6 million and included a one time noncash Doc based compensation expense of $31.4 million associated with modifications to the vesting of existing stock option grants as a part of the transition agreement of the.
Company scientific founder.
Excluding this one time item non gap operating expenses and the first quarter total $31.2 million compared to gap operating expenses, a $14.1 million into one of 2019, and 23.1 million and the fourth quarter of 2019.
Primary drivers of the year over year increase or investments made to develop report trucked in it and the rest of our pipeline, including the head count we have added.
Reported operating expenses included a total of $38.4 million and non cash stock based compensation expenses, primarily comprised of the 31.4 million dollar one time item.
Continue to expect expenses and 2020 will increase as we execute across for clinical trials for our three clinical stage assets and make investments to develop our al program and earlier stage discovery efforts.
<unk> cashews during the first quarter was $28.4 million and our cash cash equivalent and marketable securities at March 31st for $380.8 million.
We protect our cash position will fund current operations into 2022.
With that brief update I will turn it back to Atlanta.
Thank you D. to close I will summarize our goals for the year, which are advancing enrollment in each of our clinical trials.
The extent of a covert 19 impact on our clinical trial enrollment and data collection will depend on the duration of the pandemic.
As a clear area focus for our team.
Presenting a preclinical update for T.P.F. 0046 at the virtual ASKO meeting on May 29th.
Presenting our preclinical reap attractive combination data in our preclinical data for T.P.X. 0131 at the virtual A.A.C.R. meeting in late June.
Providing an update of early and term data from initial patients in the Trident one phase to study during the second half of the year potentially in the third quarter.
We anticipate this update will include preliminary efficacy and safety data from approximately 30 to 40 patients across multiple phase two cohorts, including Registrational and exploratory cohorts.
<unk> interim data from initial patients treated with T.P.X. 0022 during the second half of the year.
And advancing T.B.X. 0131 towards I into submission, which we anticipate in early 2021.
Again, I want to thank our great turning point team for all they accomplished so far this year.
Has been a challenging time with many rapidly evolving variables yet our team adaptive well and remains incredibly focused on delivering are pipeline to patients.
Operator, you May now open the line for questions.
Good afternoon, everyone. In addition to what with outlined in our prepared remarks earlier today, we announce that report tracking it has been granted fast track designation by the U.S. food and drug administration for the treatment of Ross one positive advanced Nonsmall felt lung cancer patients.
To have not been previously treated with a Ross one kerosene kindness inhibitor.
As a reminder, in January report track to Nip was granted fast track designation for the treatment of Ross one positive advanced Nonsmall sounds like cancer patients who had been previously treated with one prior line of platinum based chemotherapy and one prior line of Ross one <unk> setting where there are currently no.
Approved targeted therapies.
Our latest fast track designation was granted in Ross one positive T.K.P.K.I. naive nonsmall, so lung cancer patients utilizing age July 20 seconds 2019 data cut off date with a median follow up of 20.1 monks.
Reap attractive demonstrated it confirmed overall response rate by blinded independent Central review of 91% or 10 of 11 responders with a median duration of response of 23.1 months.
This is based on a caplin Meyer estimation.
The probability of patience with the duration of response of greater than nine months with 78%.
Greater than or equal 12 months 65 per cent and greater than or equal to 18 months also 65% respectively.
We put tracking it also showed a median progression free survival of 24.6 months.
Well not an endpoint phase one study compares favorably with historical comparisons for the two currently approved agents in this setting.
As of April 620, 20 within additional 8.5 months a follow up.
Four of the five responding Ross one T.K.I. naive patients remained in a partial response.
Physician assessment data since July 22nd 2019 data cut off and the duration of treatment ranged from 9.2.
34.2, plus months with seven of the total 11 or 64% of patients remaining on reap attracting them.
All seven patients remained on treatment for more than 17 months.
Six or 55% on treatment for more than two years, and three or 27% on treatment for more than 30 months at the time of the analysis.
In addition, reap attracting it has also demonstrated C.N.S. activity among patients with Ross one positive advanced.
So lung cancer, who are Ross one T.K.I. naive.
Intercranial objective response rate of 100 per cent three have three patients with durations of response as of July 22nd data cut off a 14.8, plus 17.6, plus and 23.1 months.
All three of these patients remain on treatment as the April 620, 20 analysis.
<unk> six plus months 28.5, plus months and 34.2 cards months, which is very encouraging given the limited therapeutic option per patient with C.N.S. disease in this setting.
Without additional information from our phase one Trident, one study and our recent fast track designation now outline we may now open the lined up for questions operator. Thank you.
Thank you I've never mind to ask a question you will need to press star one on your telephone.
So draw your question press the pound key please stand by what we can kind of the current day roster.
I first question comes from called Toyed with Goldman Sachs. Yeah mine is open.
Hi. This is cringing goes on for Paul <unk> wondering if there's anything you point out on that road has low label all over the last week and whether you see any potential impacts the ongoing aroma.
And you're studying Oh for sex with the availability of that occurred product.
Hi current thank you for the question so I hope everything's, Okay with you and your family.
Last week was a busy week, obviously with two approvals in the targeted ontology space I think we all anticipated the approval except for catnip Gorbachev's know as you've outlined.
I think I've consistently always said that I think it's a very good drug.
Think those that may have detected changes as it relates to duration of response, Andorra warnings and precaution information I'll leave that debate for them, but you know we've always been focused on how are drug differentiate.
One of the ways. It clearly differentiated is also it's selectivity as it relates to sark and potentially to the safety component that we do not hit that Jeff tree and specifically that you are too. So there may be areas that we can differentiate versus the the warnings or precaution labeling as it relates to the impact of one of the things that we were incredibly please.
Through the first quarter as well as moving into the second quarter is how our phase. One studies have progressed I think that's a testament to not only again the way that are molecules, hopefully differentiate which goes beyond just 046, but also that we have a global setting for our met inhibitor for that phase one study and also multiple sites.
For the rest program that you're asking about so you know it overall impact for the future is hard to predict I think equally as we've outlined from the duration of the pandemic, but so far we've been very pleased with enrollment for not only the <unk> program, but our other phase one studies, which included the mat.
Thank you and then.
I would imagine that conferences like the upcoming days the are often a good time for you to connect with K. will become involved in clinical trials. When I was just wondering if you could talk about how you're kind of maintaining some of those touch points given the chance to a lot of virtual a engagement.
You know one of the things I would say as many as a k. wells have also unfortunately been adapting to the new environments that have been at home much more than they would have normally Ben and so I've been just as much on line with some of the K. wells, who might have been more focused on clinic in the more recent past. So I really don't believe that any engagement has changed at least.
From my perspective, or obviously Mohammad R.C.M., though has been incredibly engaged across all of our for ongoing programs I think to your point that you're right. It's unfortunate that we don't get the face to face for many of the major medical conferences, but I don't think in any way that it deters or distracts us as it relates to trying to connect with our.
T investigators as it relates to new drugs that are approved are obviously, our ongoing studies.
Great that makes sense. Thank you so much.
Thank you next question cause I'm, Jim Birch enough with Wells Fargo. Your line of how open.
Hi, guys sys for all the detail in congrats on the progress through the difficult environment I guess first to fund Trident, one going from 100 harder than twenties sites is that just to offset the impact could cope with 19 or is there anything in in terms of screening for Ross one and then try positive patients that you're seeing different then you'd assume.
Previously.
No. Thanks for the question Jim same same common I made two current I hope everything is okay for you and your family at first I would say that we were making the decision to evaluate additional countries throughout the conduct of the trial. Just just looking back of course had given a lot of detail to a phase one updates in in the context of our Fastrak designation.
It was granted today. So I appreciate that's all new data, but to try to remind folks are phase. One study was really seven sites to countries and say the phase two is just such a much more global scale program and we've been evaluating over time, what additional countries, we may or may not bring into the trial, so going from 100 to 100.
20 actually included additional sites ethic prior countries that we had selected as well as some new countries that we selected as we've learned more true outreach to cables in those areas as well as outreach with R.C. a row, but also to the point that you're making that I think trying to mitigate any potential impacts.
Down the road were obviously, saying today that we've seen some delay as relates to cite initiation for the phase two so adding additional sites hopefully will help mitigate.
If we can going going going further.
And then you know just flipping ahead too you know what maybe an update in third quarter, but certainly second half for tried in one.
Is it still cohort two and three where we'd expect.
<unk> patients and it's wondering if that you'd have such a strong C.S. response.
Patients that could confirm you know that activity and maybe just 'cause set expectations around you know what would you expected. It is cohort two and three what would be you're actually patients on this number of patients in terms of responses we support for.
Sure. So what we've outlined today and what we said at the beginning of the year was right now in Q2, we give you more guidance as it relates to what to expect in the second half and and what we've tried to to outline is again one of the things we fed into prepared remarks is that we're monitoring overall study conduct and data color.
Section and what I mean by that is as you know many sponsors have had to allow greater flexibility right now as it relates to patients potentially having local labs and or local C.T. scans collected it's now in our shop to get that data out of the local institutions into that treating centres and then inevitably into.
Database.
What we've said today is that were potentially going to provide the second half update and third quarter, but we do you still have to watch where we are with data collection and so I can't fully answer whether it'll be cohorts two and three what we've said today is that it will be multiple phase two cohorts and at the same time to the question you asked about C.N.N.
<unk>, it's too early for me to assess how much data I have collected and patients that have had intracranial disease. When I look at kind of how I should think about the data coming in the second half, it's really probably more to the the point I made earlier about the difference between the phase one study too.
Countries versus now where we have 11 activated countries over half of those countries have now enrolled patients and so it's clearly a much more global trial, which to some may think that that would add more variability and so we want it clearly look at an early number of patients to be able to assess not only.
Chain trip to countries to a much more global scale, but also as a reminder, our phase two dose is a regimen that allows <unk>. After two weeks of 160 milligrams daily you can go and doubled the dose to twice twice daily and that we didn't exploring phase one we explored it after a shorter period after seven days so.
My assessment when I think about the data again to the point, you've made which is a relatively small data that we're looking at approximately 30 to 40 patients which is consistent we always said early initial patience I really just want to see the data obviously utilizing our phase two goes in a much more global scale trial.
Well, thanks to get for all that detail when you say thanks, so much.
Thank you Jim.
Thank you.
Question comes from Mike Schmidt Guggenheim, you know and has to have open.
Oh, Hey, thanks for pick my questions and thanks for for the details the update today.
It looks like be based on what you said the the P.F.S.N. no fronts mine sweep at night for US one patient court seems to mature really nicely.
Good good to hear that I'm just curious if if you could also share you know any updates from potential our treatment.
Discontinuations from that pays one study.
Local added more recently.
Yeah. Thank you for highlighting that Michael one of the things. We clearly wanted to highlight of course. These we taped are prepared remarks, and so we've received obviously very recently the fast track designation approval and so with that we provided in updates to the F.D.A. not only utilizing that July 2019 data cut off but also additional information.
That we received utilizing position assessment data. So we've not looked at a formal blinded independent Pincher review analysis since the July update from last year, having said that what you pointed out I think there's two points I would point out previously we had said that that that the maturity of the duration of response was not that yet.
Air and so that we had estimated that there was hi, likelihood that 65 per cent of it being at least 18 months today. We've now said that the media and has been Matt and the median is 23.1 month, which again, if you're trying to do a historical comparison remembering crizotinib duration of responses is just over 18 months.
Her progression pre survival at 24.6 months again. It compares historically put both the approved agents, which are essentially at 19 months. So adult says no blue we're looking at five and a half plus months.
Pleases the update as it relates to the phase one all we've additionally commented on today is that all of the seven patients remain on treatment and we gave the extension since what we gave in January as to where patients are with now multiple patients out over two and a half years on drugs and only.
One patient that was in a previous response that has now subsequently progressed, so that that would be gay and in terms of the update as it relates to discontinuations.
Makes sense.
Obviously hard to predict at the moment and.
The you know the additional side said, you're bureaucracy meeting, but yeah any additional color on when you think you might be able to complete enrolling the fourth registrational cord and home she think about potential fun and kind of mine.
No. It's a very fair question at what we've consistently sad is that we would give more guidance as it relates to the timeline, we have not yet given the timeline to the phase to study yet we would do that as we got closer to full site activation.
Today, we clearly said that we've made progress within the first quarter with now over 50% of our sites activated, but we've seen a little bit of a delay moving into kid too. So it's a little hard to predict right now when will hit 100% fight activation, but I do you still believe that will be in a better position to provide you a timeline potentially for trial completion.
Once we have all of our sites activated and can truly assessed the enrollment curved so it's a it's a question I can't fully answer today.
Thank you and then very nice to see the the F.D. improvement, where you from New York Novartis <unk> cap about the very broad naval including from my basement very small study.
I'm just wondering how you you know how you think about that or something to read through to your program and potential no longer term mine from two guards to pass to market and and how we should think about that as well as through the you know the efficacy bar maybe that done the wires.
One.
Sure yet last week as I said before was that was it busy week for precision oncology and I think for those that don't do the math. Unfortunately lung cancer still remains the cancer that Unfortunately has the highest rated of death and it's actually higher than when you address colon and pancreatic altogether so any advance.
<unk>.
Within the lung cancer space to me are incredibly positive so to approvals last week was was a big win for the field.
I think to the point that you're making the data we have consistently scene is that there are ways. We still believe we can differentiate as it relates to potentially prolonging duration of response with that benchmark of about 12 months.
In the truly treatment a naive patient population again and I think there were some that might have been I'm surprised by some of the data as related to the safety profile and so for US again, you know we will be interested when we do provide the update for our <unk> program, which we'd said will still be within the the second half it will produce.
<unk> safety updates and of course, we've always known that there's there's a high rate of peripheral edema without asset. So I think those are the ways. When we look at their label, we still have the same belief and conviction, we had before as potentially to how we could differentiate and then to your point I think you're correct in the fact that it was a relative.
Lovely small sample size that led to both of the indication.
Oh, great. Thanks, subpoena and appreciate the update.
Thanks, very much Michael I hope everything's going Okay for you.
Thank you and next question comes from Robert Burns It eight feeling right.
Okay.
You know thanks for taking my questions and congratulate the corner and all but smoking progress turning point is making most of my questions have been answered it already but I just want one follow up so you know as we think about the the development of all these assets looking further on down the road and take into consideration.
The higher propensity for off target resistance mechanisms later generation T.T.I. numbers are are you considering combining these assets with additional agents for example in S.H.P. two inhibitor later on in the development password. Thank you.
Yeah sure a very good question. So I think you know it was the question earlier as it relates to medical conferences and K. awhile engagement I think it's.
Fresh to highlight that we do have you know at least between the two conferences ASKO there'll be predominated preclinical update as relates to our Rett program, but H.P.R. at the end of June will really be the first place where we start to show our combination strategy. We've talked about this for quite awhile now we've continued to work.
On it we built our team to evaluate multiple ways that we can combine at least started lead asset <unk>, but we're fully aware that there is another investigational retton habit or that's now being a combined with and he'd get hard hit better. So I think your points. We are looking at our entire pipeline and combinability with.
Other targeted therapies, whether it's T.I.'s or others, but just something that we haven't necessarily shown publicly but again A.C.R. abstracts will be coming out very soon and then subsequently obviously the presentation.
Awesome. Thank you.
Thanks, very much right.
Thank you next question comes from Jim branching off with Wells Fargo. Yeah mine is open.
Hi, guys back to take in the fall.
Broader question, you should think about the profiles.
That's where you're hitting the wild type mutation and to solve it front mutations are good good.
Categories that you can point to where that becomes the preferred flat line approaches tagrisso her see that in lung cancer.
<unk> want to get a sense of you know like me to start thinking about what's going to be the dominant front Loy Asian overtime and things like multiple so lung cancer.
There's some classes for something that gets while typing in prominent.
Patients. Thanks.
Yeah sure Cham I think degree. So is is a very good example of course for one that started in a t. 790, M. and then moved clearly to the front line based on its potency I think one of the reasons that I I know we've been asked repeatedly answer that I hope today's update will be perceived positively is the phase one update her t. can I patients showing now.
The D.O.R. of of close to two years at 23 months in showing median P.F.S. of over two years, where the competitors are at 19 months I still think again is the strongest data set that we have to show why we believe reap attracting them is the best in class H. and clearly that the drug that hits wild type as well as is the only current.
That has activity in the clinic against called in front mutations. So you know when we think about other benchmark out there. We often use. The example that you've outlined integrity. So sometimes will also look at <unk> given the fact that it it started in a different setting then and now has really become the frontline agent for al positive Nonsmall fell lung cancer.
But I think it's it's a very fair point to think of how we thank each of our molecules not only differentiate her treatment resistance, but also can be best in class.
Grateful they stick and Paula.
Thanks, Jim.
Thank you.
Reminder, to ask a question you want me to 'cause star one on your telephone.
Next question comes from that good job outlook bus capital partners.
<unk>.
Hi.
Ask a quick question about any regional differences in the Roman for trading and then kinda get as since I've had that in the overlap with sites, where you were saying I'm more of an impact covet 19.
Yeah. Thank you for the question. So first I think it's as it relates to the phase one versus the phase T.. Let me just say from the phase one component was two countries. So United States in South Korea, the largest enroller within the phase one was here within the United States.
Kettering are feeds key and we've not given any guidance as it relates to periodic enrollment or wearing Goldman is coming but what I did say today is we have 11 activated countries now and over half of them have enrolled patients within the phase to show us haven't getting you specifically the countries, but at least giving you information to say that it is a abroad.
Be aware enrollment has already started within the phase to study. So that's the best way that I I could answer the question as it relates to enrollment as of today.
That's helpful things and then another follow up here I just wanted to also get us into how many scanned so what the meeting treatment innovation will likely be for the data update that may happen in we q. what tried and.
Two.
Yeah, that's something that we're currently evaluating now given the fact that we have multiple patient to have data that is still being collected from local institutions. So I wouldn't be able to give you any further guidance as to whether patients will have more than one or two posts baseline scans in the context of what the update will be because it will also be <unk>.
And then when the update will be whether it will be in in two three or later in the second half.
I think 15.
Of course, thanks for the question.
Thank you next question comes from Island.
Accord get alignments of open.
I think tricky my question.
I had maybe.
This is looking for maybe additional color on some other data sets.
P expecting towards the end of the year. You you mentioned that you were looking for 30 to 40 ish patients and exploratory and Registrational arm.
Curious.
This is trials started late last year or sorry.
Last year thing.
Are those patients and going to largely not be impacted by comes in and then.
Area about.
If you're if you anticipate any issues from requiring.
Biopsies fresh versus.
Maybe our cable and whether there's any change to.
So these patients.
During this time thank you.
Yeah. Thanks, Thanks for the questions Arlinda, we actually had previously guided and have out outlined it again in in some of our documents that currently for enrollment patients can come in with local testing. So there is no current requirement for a fresh biopsy of course, unless the patient is a naive.
He's just recently been diagnosed so the biopsy components hopefully is not a barrier for patients that are coming through within the trial at the impact as it relates to the data analysis again, it will be partially based on the last question as to where we are whiskers scan and where the patients were in there.
Paradigm to fully be able to answer your question. So I I can't answer entirely went whether any of the patience that will potentially be in the data set will have had scans. During this time more than likely they would have but again you know that the question I think you're asking is you know patients that we're headed rolled you're you're timeline was correct. The studies.
I started in July of last year, probably early patience versus more recent patients again, while we're looking at the overall conduct and data collection. It's a it's a question that's hard to answer right now.
Okay. Thank you.
Thank you very much okay.
I'm not showing any further questions at this time out America tend to call back over to the isn't that can toyota's the closing remark.
Well. Thank you again, everybody for dialing in I really appreciate the time and obviously you're interested in support in turning point Therapeutics. Given the company is you know under the stayed home directive I know many of our employees or at home and so I. Thank you for everything that you have been doing you know that I hope you and your family stay well during all.
These unprecedent times and operator, you may now close to call. Thank you.
Ladies and gentlemen, this concludes today's conference call up and give her participating you may not disconnect.
Yeah.
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Right.