Q2 2023 Chimerix Inc Earnings Call
Good morning, gentlemen, and welcome to the Chimeric second quarter 2023 earnings Conference call I would now like to introduce you to your host for today's call Michelle last Buddy, though vice President of strategic planning and press relations at Kmart. Please proceed.
Thank you good morning, everyone and welcome to the crime, Eric second quarter of 2023 financial and operating results Conference call. This morning, we issued a press release related to our second quarter operating update you can access the press release in our investors section of the website with me on today's call, our President and Chief Executive Officer, Mike Andrea.
<unk>, Chief Medical Officer, Alan Melamed, and Chief Technology Officer, Josh out before we begin I'd like to remind you that the statements made on today's call include forward looking statements within the meaning of private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties and other factors these risks and uncertainties and other factors could cause actual reserve.
Differ materially from those referred to in the forward looking statements. Please refer to our filings with the S. C. C for a more complete disclosure of these risks and uncertainties.
At this time I would now like to turn the call over to our President and Chief Executive Officer, Mike Andrea.
Thanks for show and good morning, everyone and thank you for joining us.
To be hosting the call for the first time as C E O and to provide an update on our second quarter results, which were characterized by focused execution across both the at 201 and 206 clinical programs.
Starting first with onto a one in the action study.
We've experienced strong engagement and enthusiasm across the neuro oncology community globally for this study driven in part by the scale of the unmet need an H three K 2007 at Blue Yonder, where there are very few treatment options for these patients beyond radiation therapy.
Additionally, how Greg Liana is a subset within the broader field of oncology, particularly in pediatrics that seems relatively few randomised controlled phase III studies.
Regulatory approvals to proceed in each of the 11 countries, where we are now opening sites came quickly earlier in the year and the pace with which we were moving through I R. B as in contracting reflects the poll, we're seeing from investigators to participate in the study.
Importantly, patient enrollment continues on schedule and we expect to have our first interim overall survival assessment in early 2025 final progression free survival data will likely follow next in mid 2025, and a second interim overall survival assessment is expected to occur later that year if needed followed by final overall.
Survival data in 2026th also if needed.
In parallel we've started the process of preparing the organization the program in the market for the potential loss of off 201, and I've undertaken as many activities as possible prior to recruiting achieved commercial officer.
While the action study progressing on schedule, we have recently begun an external search for this commercial leader I expect to have an update on that process later in the year.
Turning briefly to at 206, the open label dose escalation an intensification studies are expected to complete in the first half of 2024 to date dose escalation has included once a week dosing, but looking forward future dose levels include twice a day dosing for three consecutive days.
This is where we expect to capture the range of continual exposures that should increase the likelihood of seeing consistent monotherapy activity with this agent <unk>.
<unk> will provide more color on that design the safety profile, we've observed to date as well as provide an update on the previously reported GBM response on the once a week schedule.
Finally, turning to finance, we've been deliberate and disciplined with Todd expense control and capital allocation, even as we ramp investment in the action study or burn in the first half of 2023 was $33 million is the full effect of our previously announced reduction in force began to be realised in Q2.
We ended the second quarter of $233 million in cash and equivalents right on plan to meet our previous guidance of approximately $200 million in cash at the end of the year.
Under our current operational plan, we expect to have runway through each of the expected action data points and into 2027.
Financial plan does not contemplate receipt of near term non dilutive milestone payments from our <unk> partnership with emergent, but as we observe last week Bartow remains active and the smallpox procurement space and a <unk> option exercise as possible, even if unlikely in the near term.
As a reminder, each future full option exercise under the current barter contract equates to a 31 million dollar milestone payments <unk> Eric's kind of Eric's also earns a 20 per cent royalty on gross profits in the U S. Beyond 1.7 million treatment courses and a 15% royalty on all international gross profit.
For more details on our second quarter balance sheet and income statement. Please refer to the press release, which we released earlier today.
Lastly, we began a process to backfill the CFO CBO role and I expect to have an update on that process later in the year.
In the meantime, we're fortunate to have a strong finance accounting and internal control capability that allows us a bit of time to finalize that search.
With that I'll turn the call over to Josh to provide additional color on the action study and our recent engagements within the neuro oncology community Josh.
Thanks, Mike.
As you all can tell from my silver view, our team is aggressively rolled out the action trial with global coverage for several geography. The action trial represents the first time that I feel one will be made available through official channels patients with H 327, and <unk>, who are in desperate need.
We have worked closely with multiple stakeholders across the global barrel oncology comedian need to optimize the clinical trial design in a way that balances the need for scientific rigour with consideration of patient burden.
Furthermore, we have identified creative solutions to support patients and their families when possible.
This has had a direct impact on our ability to utilize referral networks as the action study side availability widens over time, so that we maximize the capture of page eligible patients who are in need today.
As a result of these efforts our connection to the global Neuro oncology community has broad in scope and regain momentum.
Over the last quarter, we have participated in multiple neuro oncology forums aimed at identifying the most important issues facing the brain tumor community and how innovative solutions could be identified an expedited.
These forums included participation in the Whitehouse cancer moonshot form on brain cancers, and the national brain tumor Society research round table events.
In addition, several team members have represented chimeric, Andy actually trial at the annual British Arrow Oncology Society, Pediatrics, now and the Canadian Neuro oncology conferences following steady activation in their respective region.
<unk> b as important as another step forward towards building our global presence in the neuro oncology community and you can expect that trend the increased throughout Europe by a direct engagements of our team at regional conferences, where action is now open.
Note that our regional event presence will be in addition to some of the larger conferences. We're here we have engaged historically such as it's no conference in November there'll be hosted this year in Vancouver, as well as the European Association for Neuro oncology or <unk> conference in Rotterdam, where we hope to see you later this year in September .
Overview I'll turn the call over now to Alan for a more detailed critical update on the <unk> program L.
Thank you Josh.
Excited to provide an update on the <unk> program, which is progressing well and dose escalation studies.
Contemplate escalate into Dallas, and increasingly frequency, where we hope to achieve therapeutic exposures. It may yield consistent line therapy efficacy.
We have two separate trials I'm, calling one at the NIH in adult patients and less children.
Specific pediatric oncology consortium with Peanuts most.
Both trial to escalate as safely a new one to make this scheduled securitas I'll apply.
<unk> has safety completed just double six.
There have been no related does plenty of toxicity study and we've observed similar safety profile between pediatrics in adult patients.
Overall, the most common treatment related adverse events were fatigue, leucopenia and vomiting.
All are generally low grade with no advance greater than a great too.
We are now moving to a dose and schedule that lots of more frequent dosing.
Our next stuff that will include twice daily dosing for three consecutive days.
Hanukkah kinetic profile exposure that is demonstrated.
Demonstrate efficacy multiple in vitro models and may increase kind of therapeutic response.
As you May recall in March we reported it investigated such response and a patient with recurrent glioblastoma without a vacation seven amputations.
This patient response remains ongoing and the patient has been on at 206 15 months now.
We encourage that the responses patients proving and durable and then once weekly does catch us so far too and the patient is tolerating so far interest patient escalation.
Was that all you would like to closing remarks.
Thanks, Alan we've continued to execute our plan is expected in the second quarter with a focus on bringing onto a 1% of patients as soon as possible.
We're beginning to prepare our organization to launch onto a one and are excited about the promise to further broaden our pipeline in the future by advancing onto a six or through business development.
But that Mark will open the call to questions.
At this time I would like to remind everyone in order to ask questions <unk> tend to number one on your telephone keypad at star and the number one on your telephone keypad.
Our first question comes from the line up Mommy right Ralph from Jeffries Molly Your line is now open.
Hi, This is Kevin <unk> first I, just wanted to say congrats Mike and.
Just had a couple of questions for you know starting with the action trial. You said you have 77 sites active could you say, whether you know around 128 is still your goal or if you could potentially.
Potentially exceed that and just any color you could provide an enrollment across different geographical region, so far or anything in the background characteristics. So far that you can share and and maybe how it differs from the the phase two trials.
Sure, but thanks, Kevin I appreciate the question. So on the number of sites will will certainly go over 100, we currently have sort of targeted 120 to your point.
The amount of engagement and enthusiasm not just in the U S. But internationally for this study.
Continues to be significant and so I think there is a scenario where we go over 120.
We'll do validation of sites and qualification of sites, but could certainly be somewhere between 120 and 140, depending on how that goes but we've been very pleased with the amount of excitement and interest in participating.
With regard to enrollment.
It's been really consistent across geographies consistent with sort of the pace of site activation in different countries.
We actually just undertook this analysis it's been.
Very consistent across the U S Europe .
Separately in the UK, where we're seeing enrollment at about the same rate.
Joshua Allen if you have other comments on that.
Any other comments.
Okay.
Okay, Great. That's helpful. Thanks, and then.
Just for 206, so you started a more optimal dosing strategy.
Could you just talk about how you're thinking about sharing data here are.
Are you going to wait for the full escalation data.
Next year.
Or could you share some data prior and and when you show. The data are you thinking about top finding it or waiting for a medical meeting. Thanks.
Yeah.
Good question, Kevin <unk>.
Previously said I think last quarter, we mentioned that will provide quarterly updates on activity of this study certainly from an efficacy perspective, if we see other signals of activity, we would expect to share that on our quarterly calls.
As it relates to the to the conclusion of both of these studies and certainly the primary purposes of this of course safety.
That would be something that we would report out in in the first half of 2024.
I don't know if you have other other thoughts or questions comments on that timing.
Now just hold onto my.
Okay, great I'll, how back in the queue. Thank you.
Thanksgiving.
Okay. Our next question comes from the line up now <unk> from capsule, one Noreen Aaronite. Your line is now open.
Alright, thank you.
Congrats on everything so I guess my first question.
Piggy backing on beyond two Essex yeah.
<unk> in terms of when we will see some robust data I'm guessing that'll be in.
2024 first task you have a sense of how many dosing cohorts your patient numbers, we might be able to see at that point.
Now, we just added a slide to our corporate <unk> published this morning or in the details of that but I'll, let I'll, let Allen summarize the strategy.
Sure Uhm, we've already gone through you're jealous.
And any adult patients and dot com or five in pediatric patients.
Now going to be switching volatile than two day twice a day three days a week and we hope to have you just levels completed by next year. So you can see in a slight that again it depends on Tolerability. We can <unk>, we hope we can and we.
I think it should be enrolled uhm.
Bye.
I think what's our guidance Mike 2024.
Oh, well a complete dose escalation in the first half of 2004.
Per se.
Yeah, I would just add to Alex comments that will go through currently there's five additional dose levels contemplated noreen, so up to dose level 11.
Which is significantly higher exposures in concentrations than than what we've seen to date through dose level six but you can look at that slide and happy happy to yeah.
Thank you.
Oh Oh no.
Mmm just out of curiosity does this mean, whether that still sore throats not.
Not considering any more expansion opportunity needs outside of H, three K 27 mm Mmm embryoma.
You just.
<unk> two onto our so it's completely.
To ask you a question I think what you're saying.
Oh six trial is now going to be in patients that are not eligible for action.
Alright, we're looking to see an activity outside of the H seven disease currently.
So what I'm asking is.
So you so with 201.
Consider anything.
Any other opportunities I guess.
For a minute to that.
Yes, I understand your question on our end so onto our one is.
Obviously, we're focused on H three K 2007 homage deleted indication.
It is a fair observation as we look at additional follow on indications.
For for 201, certainly there's been activity in Paragon glaucoma, and pheochromocytoma, an adrenal tumor that looks interesting from an ice tea out of the Cleveland clinic.
That's certainly an opportunity for for that program, but bigger opportunities are likely to be explored with <unk> 206.
And in a more intense dosing schedule an regiment so for several reasons, what we're seeing in the early biology with that program.
To the extent that we extend beyond.
H three K 2007 am within CMS tumors or outside of the CNS, it's more likely to be with onto a six is our current thinking Josh you've done a lot of work on this topic I don't know if you have other other comments.
Yeah, I think that's largely covers it but basically any of those other opportunities we were contemplating for two of <unk> well positioned for 206 fees, we validated a lot of that in the lab, maybe even some other opportunities that weren't on the radar for 201.
You've got it right the priority for two alone will be in each freaky twenty-seven them.
Full steam ahead with action that sort of supporting trial around the periphery to fill in the rest of that population than other opportunities will be prioritized for 206.
Okay.
Yeah.
The only thing I would add for two line assuming actually positive.
I assume there'll be a lot of additional studies, whether it's worth radiation with other combinations that will go on.
Hpa's have an inpatient population I think there'll be a lot more research.
Two a line.
More focused towards this specific mutation.
Okay. Okay. So that one more quick question, then uhm, so well we see anything there was a combination study peanut study with also one <unk> will we see anything come that study.
Has anything come out of that.
But peacock hasn't published anything on that and it's it's.
A study that they're running I think we have modest expectations for.
That combination, but they haven't publish anything on that yet.
Okay. Thank you so much that's all for me.
Your next question comes from the line up Jello date from Barry Gela. Your line is now open.
Alright, Thanks for taking my questions. The first one is 206 uhm.
The new dosing schedule that you're moving to could you describe how much different you.
Expecting to be.
Measures such as the duration of the therapeutic exposure.
Yeah, so the the.
A level of concentration in the dosage. If you look over the course of a week is is multiples higher than what we've what we've dosed and dose levels, 1% to six Joel and so.
Knowing up to 200 milligrams PID three times a week so.
On a simple basis 1200 milligrams per week.
At the highest dose level, if we were to graduate to dose level of 11 versus where we've been to date, which is as high as we've been is about 350.
Once a day once a week for for dose level, six so multiples higher exposure.
Mmm.
If you look at our.
<unk> clinical data that shows that prolonged.
How long the factory J with old prolonged fusion. So we just say at least in the Nonclinical models that longer exposure does definitely help with <unk>.
Did I catch in the prepared remarks that you took care of the update on a spiritual leader later in the year and if so could you tell us more about with an update would entail.
Slower actively recruiting a commercial leader job were there are scenarios here, where we're two two and a half years out from lunch.
So we're to a point in the organization, where I think we've gone about as far as we can go without a commercial leader.
In preparing for that so certainly the enthusiasm we're seeing for the action study gives us confidence to take that step in recruiting achieve commercial officer.
We will update right.
For now and the end of the year.
Thanks, Joe.
Okay. Our next question comes from the lineup advice from <unk>, when Ray and like your line is now open.
Good morning, Thanks for taking my questions and congratulations Mike perhaps the first question I have for you is a big picture question what.
If anything is going to change under your leadership.
Any changes to our strategy.
Or anything else.
Thanks said great question as you can imagine we've designed to transition plan with the intent of being at least as disruptive as possible to the strategy and that's the strategy that's been in place for a while so don't expect a big new strategic initiative during this transition our priority.
These are going to remain the same which is to successfully execute the action study prepare to launch at 201 will develop 206 to it's rightful conclusion will follow the data and will continue to evaluate external innovation to broaden that pipeline and leverage our capability to the greatest extent possible. So those those objectives won't.
Change.
In the near term and I think I think we've been quite quite thoughtful about making sure. This is a seamless transition.
Great. Thanks, Mike.
So just stay on at 206.
As you mentioned the data is going to drive your decisions, but maybe we can just think about going down the road.
Would be the next steps you think right now if you have positive data.
In a safe drugs in the first half of next year.
Yeah. So we're spending spending a fair amount of time.
Hi, awaiting ways to accelerate efficacy studies and the scenario you just described.
And of course.
Identifying a recommended phase two dose is step one and making sure that we've got a safe.
Safe dose and schedule before we before we take that step I also think it's fair to say we need to see.
Perhaps some other convincing signals of activity and the remainder of this phase one dose escalation as we get up into concentrations, where we might expect to see.
Additional additional measures of activity.
And so depending on where that is we're working on a number of biomarker.
Experiments now to to determine where we would take this drug if we if we in fact do that activity both in the CNS and potentially outside of it Josh.
Is <unk>.
Leading to work on that initiative just yet.
Thoughts on on perhaps where we might take this under different scenarios.
Yeah, I think that's a great setup nyquil. Good morning, I I think it would depend on what we see obviously so it's like I said, we need to charge into our recommended things to Dallas or at least to network exploring multiple levels in two different frequencies in both pediatrics and adults, which I think just as well up well.
Being mindful of project Optimus towards dose optimization that may need to be tackled early and.
And development, but assuming we see the <unk>, we expect to see at this increased dose schedule that that's just that is up for either follow on opportunities within CNS tumors, where I would note that I think there's an opportunity.
In one or both of these programs for sort of a seamless transition into expansion cohorts given the enthusiasm that we already have for these trials in that space and then in parallel to that is Michael leading to where we're quite busy in the lab.
Basically prioritizing opportunities outside of <unk> once once one or two doses recommended to go forward into a follow on phase two.
Two trial that we have those.
Indications prioritize for separate studies to launch, though I think opportunities for seamless expansion within CNS and maybe some separate studies outside the CNS should be opportunities available what please.
Sure about that that was coming out of these days one trusts.
Great Thanks, Josh and.
<unk> I want to ask the question that I haven't asked in awhile.
But on the subject of <unk>.
You mentioned Ah Sega one that U S procurement contracts I'm, just wondering do you have any insights.
Uhm.
Into any potential new opportunities for <unk>, either in the U S or outside the U S. As you mentioned you get royalties on sales outside of the U S as well.
Yeah. It's good it's a good question and a good reminder, that.
We still have downstream economics to potentially earn and that partnership with emerging fed.
On the one hand, it's promising that Bartow continues to be active in the smallpox anti viral spacer as we saw last week on the other hand, they're procurement of Teapots wasn't a complete surprise and we know a bar to his budget is fixed so it's sort of hard to handicap, what that might mean for 10 Bucks in the near term what I can say.
Is that if if anyone is well positioned to maximize demand for 10 Bucks at this point it will be emergent not just in the U S, but internationally and and of course, we're rooting for them.
One of the one of the big.
Variables in in the International question is HERA, which is the European equivalent of burnup and they've stood up that organization to help identify and prepare for Pandemics in Europe. Following the COVID-19 pandemic.
That organization as I understand it has been capitalized maybe not to the extent of of the U S stockpile.
It does have capital to deploy and so.
What that strategy will be for smallpox preparedness and how it <unk>.
Fit into that is of course, a question for emergent, but certainly that's probably the biggest near term opportunity internationally, how near term that is remains to be seen.
Okay, great. Thanks for taking my questions sure sure. Thanks.
Okay. Our next question comes from the lineup. So let me try from Joss frightening. So I'll need your line is now open.
Good morning, everyone and congratulations on all the progress and congrats Mike on the new rules.
One question on two one the phase three.
Are you. So is the focus gonna be Reno, agg and equally on the <unk> and Gigi criteria to measure the progression.
If the recently approved the novartis purely on random LGD, So curious about your thoughts and.
She can compare contrast, what you like and don't like any two six with also will be evaluated <unk> criteria.
Yeah, we're evaluating progression in that study on Reno Hcg, an outlet Allen comment further on sort of how we are doing that in terms of of of timing and <unk>.
Crouch I'm, Josh I'm sure, we'll have a particular.
Opinion on how we think about hcg in <unk> in this in this particular tumor type. The important thing is whether it's contrast, enhancing or not that you've got tumor volume shrinkage on both of those measures, but let's.
Dig in each of those separately, how long do you want to comment on on the PFS.
Yeah, It makes sense.
The other question.
The primary unplugging the trial.
Wow.
<unk> analysis for progression.
Based on the Arena H G. Now that was an agreement with.
<unk> as our high gratefully almost.
Has to focus their efforts twice arena H T T, we will be getting in and out.
In addition to a garden Arena L.
<unk>, but it's not a alpha controls analysis sounds there'll be less power from us.
Regarding the locally trial.
Uhm FTA has accepted.
For low grade.
That has not accepted the H T. G. At this point for that and we will see.
From that.
Josh anything else ma'am.
Yeah, I will I'll add a little color on the different different and utility.
Different Reno criteria between response and progression and points. So you'll recall the fee to data. We previously reported on included both radio H T. M. L. D D.
As a way to look at tumor shrinkage by enhancing or non enhancing MRI.
So are we could utilize both those clear regulatory guidance to prioritize Renally speaking. These are these are all W. Is so great for height brings me almost that's where the priority was given as we transition to the TFS scenario as Alan mentioned that has alpha allocation within the action trial the.
The scenario is a little simpler so when you measure progression by Rhino criteria with high grade.
Progression counts either on enhancing or not interesting disease components for T. One it can keep clear so anyway.
That one was getting at Reno criteria for hydrated Wilhelma will remain the primary criteria for evaluating progression on that study. The differences are unlike a plethora at that point, where that only measures enhancing disease.
Progression can be triggered by internet enhancing so it will still adequately capture obligations going into this study with with that one correct here.
Thank you for that color and.
The second question is.
Any guidance on the cash on me what you have is a thinking for.
Alright are you thinking of any activity that could be.
Could.
<unk> this year or next year.
Yeah. Thanks. Thanks for the question. So now in terms of our cash runway as I mentioned at the outset of the call would have been really disciplined.
On on capital allocation today, particularly as we ramp.
The action study and <unk> activation in this stage of of enrollment.
The cash.
Cash balance we have is right at the end of the second quarter, right on where where you're expected.
To have $200 million in cash at the end of the year.
Our current forecast allow.
We are looking at external assets.
Either to complement the pipeline with onto a one or 206 and dependent on on how to O. Six unfolds suppose there's a scenario where the developments becomes more important than that calculation, we do have a little bit of dry powder in our in our cash forecast that could.
It would be available for other projects and so.
We're actively looking at those I will say the bar for a business development and bringing in external projects as a bit higher.
Given the activity were seen with 206.
And nevertheless, as I mentioned earlier.
We still need to see other signs of convincing data I think to trigger a bigger investment in that program and interphase too. So we'll follow the data on that will continue to look at it assets externally as we have really for the last couple of years and if we find something where we think we can add value that meets our strategy and targeted oncology.
I think we're prepared to ash, but certainly.
Those criteria and and making sure that that it's complimentary to our to our strategy are critical as we think about bringing on any additional projects right now.
Thank you for the <unk>.
Congratulations again.
Yeah. Thanks, you meant.
Your next question comes from the lineup jealous at all.
Funky D call me Joseph Your line is now open.
Good morning, and thank you for taking my questions Uhm I have three the first one is just a clarifying question. When you said commercial leader I just Wanna make sure you mean, an individual person at the company like it's easier to lead commercial development strategy and not a farm a partner to actually lead the commercialization of therapy should.
The phase three trial be successful.
Because <unk> is that correct.
No good to a point of clarification, yes, I was referring to achieve commercial officer of the company.
Perfect. Thank you and then second you you did mention it to call the data on the <unk> program with onto a want it kind of emerged at 20% response rate was.
Sort of the level that we wanted to see it gets when we see the data in H. One 2000 for next year. What you are looking for in the.
Casey package, it's sort of a go no go decision on response rate or.
<unk> response, and then the second question is on tour. One you go with the over 70 sites and then hopefully grow into 120. Given this is a rare disease I guess, how consistent is standard of care across these individuals' Psychodiagnosis uhm.
Is that a concern at all when you looked between between different sites in regions.
Yeah. Good good good question, so I have a question for.
206 in terms of what we're looking for I'll just I'll just reiterate this is a this is first and foremost a safety study I think we've identified a dosing schedule as we think about escalation that should enable us to see some additional signals of activity.
Certainly have seen one to data and what's interesting about that is it happened at such a low dose level of 100 milligrams. Once a week and has continued through through inter patient dose escalation.
Additional signals of activity like that as we get into dose levels 789, assuming that we get that far from a safety perspective.
Think it will be important considerations for it for her.
How we take that program.
Forward and certainly within the recurrent setting those patients are eligible for for evaluation of a response. There is also an arm in the <unk> study that's in the frontline setting where those patients really aren't eligible.
Just because it's.
And and the upfront setting and you've got confounding.
Criterias such as you know.
Other other.
Therapies, whether that is radiation therapy or otherwise semi confound our response assessment.
And so we've got otherwise that we're looking for for signals of activity in and that patient population as well. So I will look at the totality of the data when we have it and.
And make a decision at that point Eleanor drastic you have other other thoughts on that question.
Just other other other contact to keep in mind, you know, it's a pretty heterogeneous group <unk>.
Rowling patients across the entire spaces CNS tumors and then as you can tell from the exposure that will come out of the study or there's a wide range of that as well. So you know given all that heterogeneity I think it's hard to pack a specific rate, but rather what we will have is it within that group patients up in therapeutic exposure range is looking for.
Signs of of monotherapy sort of shrinking tumors, and a recurrent setting where monotherapy activities a little more clear and then if there is any type of cleanup common denominators, there that make mechanistic sense. So we could charge after specific subgroup.
I feel like that's health will be looking at the data as opposed to a specific right across the entire study.
Alan and good ad.
Yeah, I think I'll, just say that we need some.
Confidence to move to a <unk>.
That will be.
Good if not better to assist in Czech population. So we will be very critical way of looking at the data before making a decision to escalate to other areas.
Mmm.
Then on your your.
Questions, though in terms of consistency of of standard of care in this population.
The big the big consideration for us as we selected <unk>.
Countries is the radiation dose and making sure that patients were getting a consistent radiation dose in that market.
At those institutions.
And so we're comfortable with that consistency across all of the sites that had been activated and then for better for worse, there really isn't much in terms of standard of care beyond that and to the extent that there is we've we've tried to make this as.
Hum August of a patient population as we can with the inclusion exclusion.
Criteria patients are allowed <unk> in combination with with radiation. Some sites would may or may not continue that in this patient population that's known to.
To have less of an effect or in fact has been proven a survival benefit and on methylated patients.
The vast majority of patients with the H three K 2007, amputation methylated so.
Mmm.
Excluding that in the action study and making sure. There is adequate wash out period has not been a barrier certainly in sight enrollment an activation.
So we've we've got good consistency across across cited spoke within countries and and across geographies globally on.
On the standard of care.
Mmm.
Yes, just to add I think in the countries that were going getting a biopsy is standard of care.
Cause it's important for understanding prognosis as well as other markers. That's part of standard testing that's being done here too Njs R. I C. That is there are some areas that we're not going to that would not always last <unk> typically I always get the tissue and then it makes sense.
Pantages radiation resection possible.
Other options out there.
Great. Thank you very much.
Yep, it's Mike and very all but happy to finish and thank you for everyone for taking the time. This morning, we look forward to giving you updates in the coming months.
This concludes today's conference Bill May now disconnect.
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Mmm.
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