Q1 2022 Better Therapeutics Inc Earnings Call
Ladies and gentlemen, please standby your conference call will begin momentarily once again, thank you for your patience and please standby.
[music].
Good morning, and welcome to the bedroom Therapeutics first quarter 2022 financial results and business update conference call. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one on your telephone. Please be advised that today's conference may be recorded if you require any further.
Assistance. Please press Star then zero I would now like to hand, the call over to Kevin Appelbaum co founder and Chief Executive Officer. Please begin.
Thank you.
<unk> good morning, everyone and welcome to the better Therapeutics conference call to discuss our first quarter 2022 financial results and business update.
Our press release was issued this morning and can be found in the investors section of our corporate website.
Better TX dot com.
Joining me on the call. This morning are Dr. Marc Berman, our Chief Medical Officer, Mark Hoyt, our Chief Financial Officer.
During today's call the team will provide a business and financial overview of the first quarter of 2022 and provide our outlook for the second quarter of 2022 and beyond.
The Q&A session will follow our prepared remarks before we begin and as a reminder, today's discussion will include forward looking statements related to better therapeutics current plans and expectations, which are subject to certain risks and uncertainties actual results may differ materially due to various important factors, including those.
As described in the risk factors section.
Of our most recent SEC filings.
These forward looking statements represent our views as of this call and should not be relied upon as representing our views as of any subsequent date.
We undertake no obligation to publicly update these statements.
Better therapeutics is successfully executing on our strategic priorities in 2022.
Notably we have made significant progress in validating and advancing the clinical development of our first in class prescription digital therapeutic for the treatment of type two diabetes.
I will share more on our progress momentarily, but I want to begin with the headline that with continued positive data, we expect to file a de Novo classification request with the FDA in the third quarter of 2022.
Marketing authorization of <unk> 001 for the treatment of patients with type two diabetes.
We expect the FDA reviewed it takes six to nine months, which keeps us on track to launch this product following FDA authorization in the first half of 2023.
A few weeks ago, we reported that the pivotal trial would be T 001 met its primary efficacy endpoint.
And demonstrated an excellent safety profile, resulting in significant <unk> reductions when compared to the current standard of care.
Dr. Berman will review this data in more detail shortly but the key takeaway is that beta 001 is producing clinically meaningful improvements in a one C with no adverse safety events due to its use.
We expect the benefit of this product relative to risk will be viewed favorably by the FDA providers and payors and fill an important gap in clinical care that exists today.
We've expanded our real world evidence program to further establish <unk> zero zero ones durability of effect and impact on health care costs and medication use.
The data generated from this program will be key to securing payer coverage and reimbursement.
We have also begun to study the potential of nutritional cognitive behavioral therapy.
As a potential treatment for fatty liver disease.
This condition affects over 64 million adults in the U S, resulting in over $100 billion.
Indirect health care costs annually.
It lacks any effective FDA approved therapeutics.
Our progress comes as more and more experts come to the same conclusion that we did when we started better therapeutics that the existing treatment paradigm for cardio metabolic disease is not serving patients as well as it could.
We spend hundreds of billions of dollars every year dealing with the symptoms of these diseases.
While doing very little to address the underlying behavioral closets.
This approach is failing patients and leaving providers without the tools they need to enact clinical guidelines.
That is why it was so important when the American Diabetes Association recently added a recommendation for using mobile apps and digital solutions to facilitate behavior change in treating type two diabetes.
So it's 2022 standard of care guidelines.
Upon authorization <unk> 001 will be the first digital therapeutics that can be prescribed by physicians to treat type two diabetes by addressing the behaviors that are root causes.
Additionally, the centers for Medicare and Medicaid services, where CMS established a new healthcare common procedure coding system could become effective in the second quarter of 2022.
This code creates a new pathway for the reimbursement of prescription digital therapeutics.
In addition, the access to prescription digital Therapeutics Act of 2022 was introduced and if enacted will expand Medicare coverage to include PDP.
We view these recent actions as positive indicators for the adoption use and reimbursement of prescription digital therapeutics.
Turning to our outlook for the second quarter of 2022 and beyond we are on track to achieve multiple clinical and regulatory milestones.
First we expect to complete the pivotal trial of <unk> 001, and received final data at the end of June and.
And we will report secondary endpoint data early in the third quarter of 2022.
Second we expanded the scope of our real World evidence study for <unk> 001, and expect to report data on the first 250 patients to complete 90 days of treatment in the fourth quarter.
Third we are gathering pilot data from the <unk> 001 pivotal study.
We'll inform the initiation of pivotal trials of <unk> zero zero to <unk> 003 for the treatment of hypertension and Hyperlipidemia respectively.
Pending favorable data in sufficient capital. These studies may commence as soon as the first half of 2023.
Last we look forward to hosting a key opinion leader webinar concurrent with the 80 <unk> annual meeting in June .
This webinar will explain the use of nutritional CBP has a mechanism of action and describe how it's used can fill a known gap and current standard of care guidelines.
Dr. Mark <unk>, our Chief Medical Officer will now provide an update on our clinical progress mark over to you.
Thank you Kevin we.
We have made excellent progress advancing clinical development of our digital therapeutics platform and the first quarter.
In March we reported positive primary endpoint data from our pivotal trial of <unk> 001 for the treatment of type two diabetes.
As a reminder, the open label randomized controlled parallel group study enrolled 669 participants with type two diabetes.
Being a baseline <unk> of eight 1%.
This is well above the clinical target of 7% or less and nearly 70% of the study population, that's taking two or more medications to lower their blood sugar.
Participants were randomized to receive standard of care with or without <unk>.
The primary efficacy endpoint is the difference in mean change from baseline and a one C. After 90 days of treatment between the two groups.
The primary efficacy endpoint showed highly statistically significant improvement in <unk> between the intervention and control groups with the difference between groups of <unk>, 4% and a P value of less than 0.0001.
<unk>, 45% of patients receiving <unk> 001 demonstrated a reduction in <unk> of at least 4%.
With mean improvement of one 1%.
Versus 27% of the patients in the control group.
We believe this demonstrates use at <unk> zero, one significantly improved <unk> <unk> compared to standard of care alone.
There was a clear dose response between greater engagement and nutritional CBT and greater reductions in <unk> supporting Nutritionals TVT is the mechanism of action.
Measures of patient engagement adherence persistence and satisfaction for all positive.
And no adverse safety events were attributed to use <unk>.
Given the clear efficacy signal that suggests a strong benefit to risk profile for <unk> 001.
The secondary efficacy endpoint for the <unk> pivotal trial is difference in mean change from baseline in <unk> between the two groups at 180 days since treatment initiation.
In addition to the secondary endpoint exploratory endpoints will include a comparison of the change in medications of the two groups.
With final data, we will conduct a broad range of subgroup analyses, including the glycemic response and safety signal within diverse demographic and medication use population.
We will also analyze changes in the population with elevated cardiovascular markers.
As Kevin mentioned, we are on track to complete the pivotal trial in the second quarter of 2022 and report secondary endpoint data early in the third quarter of 2022.
We were also pleased to have the Jerome Veterans Administration Medical Center join mass Channel breakdown, Colorado Prevention Center and catalyst health system in an ongoing randomized controlled multi site study to generate evidence supporting payer coverage and reimbursement of <unk>.
<unk> and type two diabetes.
These centers are expected to enroll approximately 1000 patients for a treatment period of at least 12 months.
Change in <unk>, and healthcare resource utilization will be evaluated at six and 12 months and compared to usual care.
Study results will be reported on a rolling basis as cohorts of 250 patients complete an incremental 90 days of treatment.
Demonstrating the potential to improve glycemic control and reduce ongoing health care cost and medication use within the veteran community is of critical importance.
Type two diabetes affects nearly 25% of the Va's patient population and is the largest driver of costs within the VA.
Following the promising primary endpoint data from the <unk> pivotal trial, we initiated the Davita liver study.
This study is evaluating the feasibility of nutritional GBT to reduce liver fat and improve liver disease, biomarkers and nonalcoholic fatty liver disease, or natural D and nonalcoholic <unk> hepatitis or Nash.
Its first ever study of nutritional CVT as a potential treatment for Nash will be Nash is being conducted in collaboration with Arizona liver health.
Leading liver clinic Research center.
This single arm interventional cohort study is expected to enroll approximately 20 patients for a treatment period of 90 days.
The primary endpoint is the mean change in percent liver fat as measured by magnetic resonance imaging proton density fat fraction or MRI PDF apps.
MRI PDF ask as a noninvasive precise measure of liver health that correlates strongly with the FDA approvable measure of liver biopsy.
This study is expected to be completed in the third quarter of 2022.
There are currently no FDA approved therapeutics to treat these diseases.
With that I'll turn the call over to Mark <unk> Mark.
Thank you Mark.
We ended the first quarter with $31 $7 million in cash and cash equivalents compared to $46 million as of December 31.
Under our current operating plan, we have sufficient capital to fund operations into the first quarter of 2023.
Our total operating expenses for the first quarter were $9 3 million compared to $3 million for the same period in 2021.
Research and development expenses for the first quarter were $3 7 million.
This compares to $1 4 million for the same period last year.
The year over year increase in research and development expenses was primarily due to the cost of advancing research in conjunction.
And with our prescription digital therapeutic Bt's 001.
Sales and marketing expenses for the first quarter were $2 million.
Compared to $43000 for the same period last year.
This year over year increase in sales and marketing expenses was related to prelaunch preparations for Bt's 001.
General and administrative expenses were $3 6 million for the first quarter of 2022 and $1 6 million for the same period in 2021.
The increase in G&A expenses was primarily due to costs of being a publicly traded company as well as cost to support company growth.
Net loss attributable to common shareholders for the first quarter of 2022 was $9 7 million or <unk> 41 per basic and diluted share.
This compares to a net loss attributable to common shareholders of $5 7 million or.
<unk> 54 per basic and diluted share for the same period last year.
With that I will turn the call back over to Kevin for some closing comments Kevin.
Thank you Mark.
Better therapeutics is built to address an enormous health care problem.
Each year nearly half a trillion healthcare dollars are spent in the U S to treat the symptoms of cardio metabolic diseases, while very little is done to address the behaviors that are the root causes of the disease.
We believe that nutritional CVT delivered as prescription digital therapeutics represents an important new approach for treating a broad range of cardio metabolic diseases, starting with type two diabetes.
Before we move onto Q&A, let me recap some important points that you've heard today.
We are on track to complete the pivotal trial of <unk> 001 in the second quarter.
We report secondary endpoint data early in Q3.
With continued positive data, we plan to file a de Novo classification request with the FDA in the third quarter.
And anticipate the FDA review process will take about six to nine months.
In one on one meetings payer response, the primary endpoint data was very positive, particularly with respect to the diversity and complexity of the patient population and effective bt's 001 incremental to standard of care.
With final data, we will complete our health economic models and begin to engage payers and coverage discussions in Q3.
We expanded the scope of a real world evidence study for <unk> 001, and expect to report data on the first 250 patients to complete 90 days of treatment in the fourth quarter of 2022.
We initiated the first ever clinical study evaluating the feasibility of nutritional CVT as a potential treatment for fatty liver disease. We expect to complete this study in Q3 and report on the primary endpoint in Q4 2022.
And last we are gathering pilot data from the <unk> 001 pivotal trial that will inform the initiation of pivotal trials of <unk> 002, and 003 for the treatment of hypertension and Hyperlipidemia respectively.
Pending favorable data insufficient capital. These studies will commence as soon as the first half of 2023.
Together these initiatives reflect an emerging standard of care for the treatment of cardio metabolic diseases.
Built on a foundation of behavioral therapy delivered as prescription digital therapeutics.
We're now ready to take your questions. Thank you.
Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
And our first question comes from the line of Thomas Flaten with Lake Street Capital. Your line is open. Please go ahead.
Good morning, guys I appreciate you taking the questions with respect to the cash runway into the first quarter, what does that contemplate in terms of Hercules financing.
There are incremental drawdown.
In that assumption.
Mark you want to take that.
Sure Hey, Thomas Good morning.
Yes, our intent is to pull the next $5 million on the Hercules agreement down later this year.
Got it and.
With respect to the prelaunch activities and you had some increase in sales and marketing spend could you talk a little bit about.
What youre doing between now and approval and then how we should think about spend ramp.
As we approach an approval date.
Sure I'll take the first half of that question Thomas and then maybe Mark will add a little bit to the second part.
<unk>.
We are.
Accounting for the investments, we're making in a real world evidence initiatives sales and marketing expense.
Those real world.
Evidence studies have ramped up in the first quarter of this year and we will expect to conduct them over the course of the remainder of the year.
The other prelaunch activities are related to.
Payer engagement.
Medical Affairs.
And marketing activities, such as branding naming.
In preparing for launch, but the principal investment over the course of this year will be the generation of real world evidence.
Got it.
Mark.
Yes.
Beyond that Thomas would you expect sales and marketing over the next three quarters to continue to increase modestly.
We're not providing operating expense guidance at this time, but.
As we mentioned, we'll have sufficient capital to get us through or into Q1 of 2023.
Got it I appreciate it and then are there with respect to the.
The read through on for example, hypertension could you just give us a sense of what you would need to see in order to feel like you've validated. The approach would you go straight to a pivotal would you do another pilot study can you help us think through.
How you guys are approaching that.
But mark do you want to go first I can wrap it up.
Sure.
We're approaching that Hey, Thomas.
A couple of thoughts one is.
Do we see a signal in the current data suggests that broad mechanism of action across.
Multiple cardio metabolic conditions like hypertension and Hyperlipidemia.
We already know the answer to because we've seen a clear dose response with the behavioral therapy.
And its results and action on behaviors and they want to see and then the second is that we're looking to see a degree of change.
Obviously, a favorable change in cardio metabolic outcomes in particular among.
Those who have elevated baseline measures.
As we see that.
And whilst I understand the variance, which allow us to plan a pivotal our inclination would be to go straight to our pivotal rather than a subsequent pilot.
Especially since we've already have prior pilot data in these conditions.
Excellent appreciate you taking the questions. Thank you.
Thanks Thomas.
Thank you and our next question comes from the line of Charles <unk> with Cowen. Your line is open. Please go ahead.
Yes, thanks, guys for.
Taking the questions here.
Kevin if we submit here in the third quarter for <unk>.
You mentioned six to nine months of review.
How quickly upon approval would you expect to be able to.
Launched a product any other I know, we're doing sort of pre launch.
Ramp up in in preparation, but once approval what do you think the timeline would be to actually getting the product in the market.
Yes, Thanks, Charles So our plans are based on the assumption that the marketing authorization will occur.
In Q1 and potentially very early in Q1.
Which would be sufficient to allow us to get to market with first prescription written in Q2 of next year.
Great.
But when we talk about the Fda's review process here, obviously, great safety profile significant.
The change in <unk>.
Can you talk a little bit about the matrix that the regulatory the regulators use as well as payers when they look at between efficacy versus safety.
Maybe versus prevalence.
The need for treatment in these types of not just here, but in any disease in general, but can you talk about.
What the but.
But the balance that we typically look for.
And how do you think this PTC, Arizona, one stacks up.
Yes, Great question, Mark do you want to go first on this one.
Yeah happily I think generally speaking Charles amongst both groups. The first question is is there an unmet need in the population as this is serious and.
Significant disease that is in need of additional therapeutic so that with type two diabetes.
Is it clear yes.
And then there really looking at a benefit to risk ratio.
Not good enough just to have benefit but have extraordinary risk.
So theyre looking at the relationship between benefit adverse.
When it comes to the FDA since their mission is to.
Guard public health in the country.
We're going to be more concerned with safety then benefit, but obviously looking at bell so given that we haven't yet.
What would be characterized as a extremely safe.
Profile for this therapeutic without any adverse events that are attributed to use of the device.
And if you pair that with a strong and clear efficacy signal.
We expect the FTA and payers to look at that data and that benefit to risk perspective, and see a favorable ratio.
That's helpful and then when we think about pairs Kevin.
Our discussions with them I was curious as to how your discussions are going because we've spoken with payers.
Two obviously health economic studies is important because youre looking at substitution.
Effects.
Cost, but they also really way clinical urgency as well.
Obviously diabetes is a huge problem in the U S, but maybe talk about their perceptions and in your conversations about how they view clinical urgency in this case.
Sure I'm happy to do that so following the readout of our primary endpoint data.
We had a series of one on one meetings with payers and these were mostly regionally dominant a national commercial insurers.
The feedback we got was fairly consistent across all payer meetings.
Intended to focus on several key benefits that based on the data.
One was the diversity of the patient population.
This is a significant issue and for many payors.
Providing greater access.
So therapeutics that can address underserved.
The highly diverse patient populations is among the top of their strategic priorities for the current and next year.
The diversity of the patient population.
Was one key factor. They took note of the second one was the complexity of the patient population.
Mark mentioned the majority of the patients involved in our clinical study.
We have multiple comorbidities that are on two or more medications for lowering blood sugar.
Had diabetes for an average of 11 years and yet they have scaled to achieve their glycemic targets of getting very when see the seven or below.
Payers group confirmed with US that this is the population.
That drives costs.
They are most concerned about are most motivated to try to address that.
In fact, we received several comments from payers that were complementary of study design.
Specifically on not focusing on the earliest newly diagnosed population, but the population where the need is the greatest.
And then lastly, there's broad concurrence that there was a gap in clinical care.
That gap is evidenced in the fact that despite the use of.
Medications.
Innovation in medicine less than 50% of the diabetes population is able to get their blood sugar under control relying exclusively on pharmacotherapy.
So the idea of delivering a prescriber will.
<unk> therapy.
As an intervention.
Diabetes population was well received.
Last point I'll make there Charles is certainly the first step is to get the end of study data.
It was an FDA authorization.
Payers will also.
B looking for real World evidence and what that evidence tells us around durability of effect and impact on cost.
Yes.
Thanks, if I could just follow up on that last part durability of effect.
That's to track patients after they receive treatment.
And to see if the effect is lasting so I guess ultimately right is the idea here that patient over time don't necessarily have to be on Tpg's Jersey, one in perpetuity because they all have learned to skills have been able to change behavior and get their blood sugar under control.
Yes, that's exactly right Charles and that's what's different around our approach in developing a therapeutic that is not intended to be used for the rest of the patient's life.
CBT.
Is it time bounded form of therapy.
Tends to deliver optimal results over a treatment period of roughly four to five months.
And that's what we would expect to see in our patients that after one or two cycles of treatment each one being 90 days in duration.
A significant number of patients they will have been able to change the behaviors that are causing their diabetes and sustain those behaviors over some period of time.
I would imagine.
Payers would find that very.
Encouraging as well is that fair to say.
Yeah, I think theres, two things that Payors three things payers part to the fact that this is not a chronic treatment.
Hi.
Optum.
Optimal benefits can be achieved after one or two treatment cycles.
The opportunity to treat disease by addressing the root causes which.
They quickly understand that if youre able to do that effectively you are able to reduce the ongoing use of medications and it's very easy to ascribe.
The economic benefit to reduce use of medications.
And then lastly, it's a form of therapy that can be accessible.
Through the parts of the population that are most in need.
The complex patient populations and particularly those.
Lower socioeconomic.
Classes.
Great I appreciate all the comments thank you.
Sure. Thanks for the question.
Thank you and our next question comes from the line of Kleenex.
Sheridan Your line is open. Please go ahead.
Thank you.
So Kevin.
As you think about you getting ready for filing can you characterize how well situated you are to complete all of those task given the fact that the company's first time going through the exercise.
How quickly do you turn it around once you get final data I imagine you've got a lot of it already written down.
Yes. Your imagination is quite accurate Mark do you want to tell you about where we are on the process on how we calculate the remainder of it.
Yes, absolutely I mean, given as you pointed out that this will be our first de novo submission.
We have been working on this since the beginning of the year with a lot of expert guidance from.
Our consultants and our regulatory team that has done multiple.
Related.
Novo submissions for prescription digital therapeutics that we have good guidance and a good team that's been working from the beginning of the year.
Also since we have the primary endpoint data have the data in hand, which will.
For the bulk of the submission so we're working nicely towards the milestone and we have Oh, we think is an aggressive yet achievable.
Our goal to submit shortly after the day 180 results come out at the end of the second quarter.
Okay, Great and then.
With respect to the real World study I wanted if you can give us a sense of.
With those patient baseline characteristics demographics look like compared to what was in the study.
Mark when I go first I'll finish up.
Sure Yeah, well this isn't on real world evidence.
Study is ongoing and still recruiting.
So we don't have a full set of baseline characteristics to report, but our expectation is that we will see very similar demographics, because I think the strength of the <unk>.
001 pivotal trial is that we are able to recruit a nationally representative sample.
And in the real World evidence program, we have sites that are spread.
Around the country and also we have a sense of what their patient population in general looks like and it doesn't match the general.
The patient population characteristics for type two diabetic patients who are not achieving their place they make target. So our expectation is that the profiles will be comparable and similar and therefore the results would be generalizable.
And we will obviously be eager to share that out once we have the data in hand.
Okay, and maybe switching gears here to.
To the platform and you talked about plans for 00003.
Once you get the pilot study data.
And it's informative.
Wade.
Would perhaps suggest some tweaking of some modules.
Now how quickly are you able to do that I guess, how much overlap is there between those products.
001 and is it just.
Changing some of the lessons or how do you how do you go about tailoring.
002 years ago, three for the different indications.
So I'll start on that one of the Mark please follow if you'd like.
So the development work for products sold to another three is largely complete.
And you hit on some of the high points.
You have to modify the fundamental architecture of the.
Of all of our products is similar.
Treatment algorithms.
Same way in terms of what inputs do they consider to deliver which outputs.
What the lessons are updated to be specific for the targeted indication.
The associated skills, while the methodology is common the specific skills themselves will be tailored to the specific indication and then certainly the biometric values that we.
Both measure over the course of treatment.
And incorporate into treatment algorithms.
Unique for the for the targeted indication.
But relatively speaking.
The platform itself allows us to make the modifications I just described in a modular fashion.
Very efficient.
I'm pretty.
Forward and that work is essentially complete right now.
Okay very good that's helpful. Thank you.
Yeah sure.
Thank you and our next question comes from the line of IL <unk> with <unk>.
Science capital. Your line is open. Please go ahead.
Hey, guys. Thanks for taking the questions.
So I guess, the 180 day readout.
What are you kind of expect to see in terms of medication change in and going off of that.
Should we see a reduction in medications.
I guess could that affect the net difference that we ultimately see a one C is really how should we think about comparing what we saw at the 90 day read out for us.
Okay.
But I think we lost Rahul for a second but I think we got the majority of the question sorry.
Sorry, I'll just takes that long.
I think we got it rule like we can just luxury lost last few words.
Perfect.
Yeah, Eric Hall, that's a great question and it's important to understand that.
The strength of this study is that it it tries to mimic real world conditions and ensure that patients are getting very good quality standard of care. So in practice what that means is that the 90 day point when blood.
Blood sugar I use are reviewed by the physician.
They're going to recommend medication changes as appropriate for the guidelines.
And so that means that you.
You know there is a high potential to see an increase in medication utilization.
You know and one which one would you expect to see a greater increases in the control arm.
Given where they ended from a glycemic standpoint at the day 90 point.
So that's certainly does have potential to impact the day 180 results.
That's our plan to tease out the results looking.
Those who had medication changes and those who did not have medication changes.
And and at the same time, despite that we still expect to see a statistically significant difference between the groups.
At the day 180 and of course, we'll also be looking to see.
The degree of medication reduction that is observed, particularly at a 180 time point.
But we also know that.
Our most important will be the <unk> change given that it's a nuc therapy.
We expect that there'll be some degree of clinical inertia at play in terms of hesitancy to lower medications.
And given that these patients are on a large number of medications.
To begin with.
We know that it wont be across the board increases in medications for for example, the 90% of the control group that would technically a plus b candidate for medication increase.
Got it okay, alright that makes sense I appreciate that and then just one more so.
Gearing up for this next readout and I'm thinking about when we might see from these you know with this pilot data data honestly I guess, what are some reasonable expectations for improvements in blood pressure and in lipid levels compared to you know I guess, what we see with existing therapies.
Yeah, we want to be cautious Rahul about setting.
Got it.
Forward looking projections of what we're gonna see you know as Mark mentioned one of the things that we observed in this population as they're heavily medicated.
Heavily medicated not just with him take like cement medications, but anti hypertensive medications. So you know we're gonna have to look deeply into the data to understand you know look at parts of the population that whose hypertension was where hyperlipidemia was not well controlled.
At baseline.
To understand what impact <unk> 001, without what impacted nutritional CBT.
Have on their blood pressure and blood lipids.
So the long and short version of that answer is.
We're gonna have to look into the data into the subgroup analysis to try to get a clean read to see what what changes we observed.
We would expect is absent.
There can founder of medications, we would expect both of those conditions will show meaningful improvements.
Got it okay, but it also makes sense all right really appreciate the questions guys. Thanks.
Yeah. Thank you.
Thank you and I'm showing no further questions at this time I would like to turn the conference back over to Kevin Appelbaum for any further remarks.
Yeah. Thank you operator, thank you all for your time today and for continuing to track our progress.
Proud of our achievements so far this year and look forward to keeping everyone informed as we continue to execute on our upcoming clinical and regulatory milestones.
Please feel free to reach out to us if you have any additional questions and again, we thank you for your time.
This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
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