Q3 2022 BioXcel Therapeutics Inc Earnings Call
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Got it.
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Good morning, and welcome to the bio cell Therapeutics third quarter 2022 financial results conference call at.
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Just to remind everyone certain matters discussed in today's conference call <unk> answers that maybe given to questions asked are forward looking statements that are subject to risks and uncertainties related to future events and the future financial or business performance of the company.
Actual results could differ materially from those anticipated in these forward looking statements.
Risk factors that may affect future results are detailed in the company's quarterly report on Form 10-Q for the quarter.
Her ended June 30th 2022, which can be found at www dot biologics cell therapeutics dot com or on www Dot FCC dot Gov, which will be updated in its quarterly report on Form 10-Q for the quarter ended September 32022.
As a reminder, today's conference is being recorded.
Joining us on today's call are Dr. Emel Mehta, Chief Executive Officer, Richard Steinhart, Chief Financial Officer, Matt Wiley Chief Commercial officer, Dr. Rob.
Rob Risinger, Chief Medical Officer of Neuroscience, Dr. Frank JAKO, Chief Scientific Officer, and Dr. Vince O'neill, Chief Medical officer of oncology.
It's now my pleasure to turn the call over to Dr. Mehta, CEO and founder of bio itself Therapeutics. Please go ahead.
Thank you operator, welcome everyone and thank you for joining our call today to discuss by some type of financial performance and business highlights.
The third quarter of 2022 market is at that moment in the history of buy it goes out of your day.
In the last few months, we have transitioned to a commercial organization and successfully launched economy.
We have made tremendous progress across all facets of our business and are very excited for 2023 and beyond.
We continue to fully execute on our land and expand strategy for our lead program <unk> and fiber one to boost our neuroscience education franchise.
In that regard we have multi part of pivotal data readouts from our ongoing expected in the first half of 2020.
We believe this will allow us to capitalize on the 15 billion aggregation market opportunity.
This consist of 139 million episode.
In total we bought our first three indications, including bipolar disorder schizophrenia and other items.
Agitation is then.
Under diagnosed and those are markets that have not seen these men.
In nearly a decade.
The economy is approved by the SBA or acute treatment of agitation and schizophrenia and bipolar disorder.
There are approximately 16 million agitation episode of <unk>.
These conditions in the U S annually, which all of it.
So you did in the infusion of American circuit.
We totally believe big.
The introduction of economy will drive education market creation in a similar fashion as the emergence and rapid growth of the depression market. Following the introduction of Norwegian.
My dog shows.
Only 19 nineties.
<unk> is a novel product with a broad label.
The full spectrum of agitation and schizophrenia and bipolar two disorder.
In short we are blazing new today is India education market.
We recently, well Sudhakar mentioned day, and clearly outlined a walgreen education market dynamic.
Initial momentum.
Logical format.
Yes.
In neuroscience.
I think products like <unk> gotten me with novel mechanism of action has never been launched.
So Pete.
The institutional setting.
Our commercial pad is unprecedented.
So our view is that okay.
Yes, there is a clear demand for.
Thus far macroeconomic banner.
And safety or health care professionals.
Patients.
Within the first four months and with only jointly.
Joining me thinks of apps initially covering 700 target hospitals.
We have already observed in good evening, Mark Becks it.
I appreciate you're targeting and highly favorable market value.
We recorded our first product revenue.
And are pleased to have extensive market reach and hundreds of formulary review scheduled in hospitals within a short path.
Based on these factors, we made the strategic decision to expand our sales footprint across all major geographies.
Market.
By December plus we will increase our sales force and deploy a total of 70 that took out approximately 1700 target hospitals.
We now have fully integrated commercial and medical teams with the necessary infrastructure to cover that.
U S education market to fuel our growth.
To drive additional awareness and understanding of economy, our medical affairs teams have been actively engaging with the medical community and PMT Committee members.
Two participating and leading in this steep on vince's across the country.
Hey, Don Maier goodness and scientific validation continues with too many scripts from our pivotal palisade and you guys.
Recently published in leading scientific gentlemen.
Yeah.
We believe all of these efforts will facilitate a formulary approval at our key forecast that will result in demand generation.
Our Chief commercial officer, Matt Wiley will walk you through our launch progress.
And they view the launch performance me if this is sharply.
In addition to our launch progress our robust clinical pipeline is advancing that Brady.
We are extremely enthusiastic about our indication expansion opportunity.
Most of the related agitation.
We then estimated hundred million annual agitation episode in the U S.
No correct.
<unk> be approved therapies for these patients this represents a large and growing unmet medical need.
501 of the themes breakthrough therapy, and fast track designations from the FDA for agitation related to dementia.
We are looking forward to announcing top line data from the tranquility to pivotal trial in first half of 2023.
Also we will be initiating the banquet 83.
At the end of this year.
We are also excited about delineated three pivotal program and potentially expanding 501 for at home use to treat agitation associated with bipolar disorder and schizophrenia.
Yeah, the approximately $23 million agitation episode of these conditions in the U S annually.
These top line efficacy data read out from the city nearly three pivotal trial is expected in the first half of 2023.
Nearly three has many battles with do you see any of the one and two trials that formed the basis. What are you asking me the approval.
<unk> is expected to more than double our current market opportunity with regards to me.
Truly a pipeline within a product <unk>. One also continues to be evaluated and then an adjunctive treatment for major depressive disorder or <unk>.
We have already completed my people cohorts in our phase one dose escalation trial in healthy volunteers and expect to report top line results in the first half of 2020.
Let me turn to encore cell therapeutics. This.
This fully owned subsidiary is focused on the sustained growth of company's immuno oncology franchise.
<unk> 701, our lead program is a systemic activator of innate immunity in Dublin for aggressive form of prostate cancer in combination with Keytruda.
We are pleased about the promising data for that one no one in small cell neuroendocrine cancer or <unk> recently presented data at the prostate cancer Foundation.
In Q3.
There is no FDA approved treatment in CNC and a high mortality rate.
Hey, Todd I must say the composite response rates of 33%.
For the first 15, Evaluable <unk> patients and a median duration of nine months in the first five responders.
We have now completed and the ongoing phase two activity.
CMP pad and expect to present top line data in early 2023.
In addition to that we are presenting data on potential predictive biomarkers for 501 in patients with leukemia, including acute myeloid leukemia.
We also believe these biomarkers could have potential implications for <unk>.
Solid tumors.
The poster will be available on our corporate website. After this call.
Oh.
We continue to strengthen our intellectual property portfolio.
501, and this quarter, we had two new U S paradigm as it should.
Do you ask notices of allowance and seven paradigm from foreign offices.
We expect these patents will be included in FDA approved drug products with therapeutic equivalents evaluation, which is commonly known as the Orange book.
Additionally for 701, we had eight patent allowances slash issuance it received from foreign offices.
In closing my accent that everyday.
The Mark cable, Florida, we are developing a leadership position in the education market.
Our multiple upcoming data catalysts and are well positioned for growth in 2023.
I would now like to turn the call over to Matt Wiley.
To review our launch progress Matt.
Thank you <unk> and good morning, everyone.
As we reported in our commercial day, a few weeks ago, we're making very good progress on our gourmet relaunch efforts. These efforts are continuing to pay off and I'm pleased to share. Some additional updates with you today, specifically in relation to our launch performance metrics.
Our market access activities are a critical component of our strategy. So I'll start with our progress with group purchasing organization or GPO contracting efforts.
As we have mentioned in previous communications, the typical contracting timeframe of GPS averages six to nine months.
We have made steady progress and increased our access the GPO throughout the quarter.
We are now contracted with two gpus, including the largest in the country covering nearly 50% of the beds in our target universe.
We are in ongoing negotiations with the other leading GPS and expect to continue to improve our access in the coming weeks and months.
As a reminder, the three largest GPO represent over 90% of our target bets. So we are very happy with our achievements to date.
In tandem we continue to engage with integrated delivery networks or idms.
<unk> on those systems that exert high control to drive further downstream utilization of our call me.
We are concentrating on 59 high value idms with formulary voting currently scheduled for 21% of the targeted bets.
As part of our ramp up efforts, we've deployed a team of corporate account directors dedicated to coordinating with our sales team and driving the formulary and contracting activity.
We have learned a lot about the deployment process in the last four months being in the field.
And the first wave of our sales deployment, we chose 26 high volume territories, covering seven 700 target accounts and received resoundingly positive traction.
We have been able to now reach over 75% of this initial target universe and have seen significant interest in pull through as PNT committees continue to add a gaumy future agendas.
These positive results give us great confidence to deploy a full 70 person sales force targeting approximately 17 100 hospitals.
This will equip us to build upon the strong momentum we have made since trade launch in July we.
We expect to deploy this team in the field by December one.
To ensure ongoing optimization and informed deployment of our field force we have taken a unique approach to our sales strategy by building out a database of 81 billion record spanning more than five years.
With this data Lake, we were able to examine and refine our targeting methodology by building a hierarchy of target hospitals informed by the location and frequency of agitation episodes.
The model we have today represents the majority of agitation episodes in bipolar and schizophrenia patients and takes into account nearly 80% of the total psych beds in the United States.
Turning now to marketing, we will continue to build on our peer to peer programs and digital marketing efforts for the balance of the year and amplify these efforts in 2023.
To date, our peer to peer programs have engaged over 1000, hcp's at speaker venues and conventions.
India Gaumy now available digital campaign has yielded significant engagement with over 140000 visits to our HCP website.
Our understanding of <unk> value proposition in this market continues to evolve and strengthen.
Just a month or so ago, new data from the American College of emergency physicians was released showing that more than half of emergency room physicians have been physically assaulted.
With one third sustaining an injury.
Bipolar and schizophrenia patients are much more likely to commit emergency department of Salt and the current treatment paradigm for agitated patients may be exacerbating this issue.
The dynamic provides a nice tailwind for are going to enter the market highlighting an additional and previously underappreciated value proposition.
In summary.
The market conditions, and our gourmet receptivity are setting us up for success in 2023 and beyond we have nearly 50% of our targeted beds on our contract with GPS with others in process, we have 21% of the target IBM beds scheduled to vote with nearly 41000 target beds and an additional 15000 tier two beds in progress.
Additionally, we have over 120 out of 700 target hospitals.
Scheduled for PMT, Vo and nearly 353.
350, PMT votes for tier two hospitals and process <unk>.
Keep in mind. This is reflective of our initial 26 territory deployment.
Both the IV and in PMT scheduled votes have improved since we last reported these figures on commercial bank.
And we expect these boats in process will continue to decline.
Additionally, we have added positive formulary wins since our last readout and we will provide more specific details on this metric in future calls.
Now I'll turn the call over to Richard who will give a financial update Richard. Thank you, Matt I will now review, our third quarter 2022 financial results.
Net revenue for the quarter was $137000 driven primarily by early trial of the gummy with limited market access.
The Companys direct shipping model to hospitals, no wholesaler stocking was expected.
Research and development expenses were $22 1 million for the third quarter of 2022 compared to $11 9 million for the same period in 2021.
The increase in R&D expenses was primarily attributable to an increase in clinical trial costs as the company expanded its <unk> 501 clinical program for Alzheimer's related agitation schizophrenia, and bipolar related agitation at home use and M D.
Selling and general administrative expenses were $17 1 million for the third quarter of 2022 compared to $14 9 million.
For the same period in 2021, the increase in SG&A expenses was primarily due to personnel and costs related to the launch of they'll call me in the United States.
<unk> Therapeutics reported a net loss of $41 8 million for the quarter for the third quarter of 2022 compared to a net loss of $26 8 million for the same period in 2021.
Cash burn for the quarter was approximately $31 5 million, which is consistent with the first two quarters of 2022.
As of September 32022, cash and cash equivalents totaled approximately $232 $3 million.
Now I'd like to turn the call back to them.
Thank you Richard we would now like to open the call for questions operator.
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<unk>.
Our first question today is coming from Greg Harrison from Bank of America. Your line is now live.
Hey, good morning, guys glad to see the progress and thanks for taking our questions.
So how should we be thinking about the timing from here on.
The 470 panty decisions you cited and the rate at which you can expect those to convert into the formulary wins.
Good morning, Greg.
Thank you for your question I'll pass it on demand.
Yes, so Greg those are currently scheduled between now and the end of the year or into Q1 of next year. So we would expect that should those agenda is actually it.
Go to vote on time, which.
These things can get get pushed but typically we would expect the majority of them to happen on time.
Then they'll go to vote and once the decision is made to put <unk> on formulary one of the things that I had provided in the commercial day.
Is the expectation of uptake and so over the course of the year, both emergency department physicians in sites.
The majority of them would expect to try and call me within that first year post formulary access.
Okay.
Got it that's helpful and then on the uncles textile side.
What are your expectations for the differences.
Between the 701 monotherapy arm in the Keytruda combo, just trying to think through Mechanistically what extent.
What the expectation could be for.
701 response.
Sure.
Vince do you undertake that ocean.
Sure happy to do that hi, Greg. So I think the bottom line is we don't know he said no one will be <unk> as a monotherapy in a cold tumor. We know said no. One has single agent activity and how hot tumor.
Melanoma and that was.
Data generated by a point to a few takes quite some time ago. We do know from the preclinical work that we've done extensive preclinical work with presented to them a lot of that but it really seems to be the synergy between the checkpoint on 701.
So that's probably the.
The best answer I can give it and we don't know, but we think primarily fundamentally it is a synergy between the two coke.
Got it well thanks for taking the questions and congrats on the progress again.
Thank you Greg.
Thank you next question is coming from Colin Bristow from UBS. Your line is now live.
Hey, good morning, and thanks for taking my questions and congrats on the continued progress.
So that's a little closer so just just curious when you expect to provide a more substantive update and sort of details the path forward and structure there.
And then just second one more of a broad sort of <unk> 501, just what is your best guess on when you'll be in a position to I guess a report a sales number that youll could've enthused about.
And b sort of provide ongoing sales guidance.
This is a much debated topic, but I think it's an important one from the investor standpoint. Thank you.
Thanks, Colin for your questions. So regarding the sales guidance.
As I said that we carry.
Currently.
Unprecedented data area because.
Product like a guy let me within our mechanism action has now been launched in the institutional setting. So what we are doing as you can see it building our launch matrices and once we build robust confidence in those metrics based on that we will start providing the guidance so with that I can pass it on to Matt to provide more.
Yeah, So Colin I think the way I would frame. It up is this I mean, we said that the process for formulary access typically takes six to 12 months, we have a lot of activity ongoing with just 26 reps in the field.
That's that's about to change and so the early progress that we're making is very encouraging.
Certainly getting on formulary as when we can truly open up true demand.
Driving activities and we would expect that as these formularies.
Our adopted in these hospitals that our team is going to be able to very rapidly a pull through demand now we do know and I mentioned this earlier.
There are uptake expectations and trial expectations based on market research.
But some of the early enthusiasm from early formulary hospitals.
Gives us good confidence that when the when the formularies do get.
Approved in the hospital that the demand will shortly follow so so we feel really good about that and just dovetail on demos point this is unprecedented.
No no neuroscience drug has been launched in the emergency Department and so we're breaking new ground here.
We feel really good about the response, we're getting.
Great and on the <unk> sale sort of update Paul forward structure.
Gordon can you please repeat the question.
Just in terms of your plan so <unk> XL.
Yes, just more details around the path forward and structure there.
Sure.
<unk> XL as.
We presented the initial data update for our first 15 patients in our CNC thats very encouraging with 33 person come positive response rate and durable responses.
There is no approved therapy.
We have completed the full cohort of now 28 patients and that data is now getting analyze and will be presented early next year with this data in hand, we will explore all of the possible strategic options, including partnering as well as third party investments on Kodiak, well, we're very excited.
With the progress for 701, what we have seen in SCS.
Yes.
Yes.
Okay, great. Thank you.
Thanks Carlin.
Thank you. Your next question is coming from Roman Karnofsky from Truest. Your line is now live.
Oh, Hey, Hey, Thank you so much for taking my question. This is a niche on for Robyn.
I have one on <unk>.
What are the main pause there to highlight and also push backs if.
If any.
And that you are hearing from your distribution center.
Condition.
Well I mean, so first of all thanks for the question Robyn.
<unk>.
I haven't really heard any negative pushback on the product itself of course directors of farming Youre always going to question the price.
But that isn't truly a negative and actually when we think about the value proposition of our gourmet and the potential for either throughput or the reduction of staff injuries and things of that nature.
Administrators and hospital pharmacists do understand that value.
A lot of what we're hearing is the onset of action is very favorable the expectation and just reading through the product profile and hearing our gourmet story.
They truly do understand the value proposition. So we're getting great response keep in mind that prior to launch we conducted market research, where we provided just product profile.
And just based on that product profile, we intend to use the drug was 20%.
After we told the complete story that we're now using in the field that doubled so they expect two out of every five patients to get this drug that's a pretty compelling set of market research and that's playing out in the field. We're hearing the same thing from our reps.
Okay great.
And then move on.
Jim I'll take.
Looking ahead to the dementia and look at how good launch in nursing homes and long term can be different.
From Shins opening your micro loan market and do you anticipate that option in diamond Shamrock is being fostered on slower than this year.
Welcome to the market.
So so Robyn we're doing the work now to create a market entry strategy and so we will communicate that over time, when we have better clarity on it.
<unk> to say the early market research that we're seeing is very compelling and that there is definitely an unmet need in this market. So we expect it to have.
Really good penetration into that market.
And it's a different market dynamics, because we've been nardi.
<unk> institutional setting so as Matt said, we are developing in market and to start again, we laid out more close to our data readout.
Oh, Okay got it thanks, thanks for taking my questions.
Thank you for your question.
Thank you. Your next question is coming from Chris Howerton from Jefferies. Your line is now live.
Hi, all this is AJ for Chris two questions for me.
My first one is about the launch so are you seeing any early trends and youth concentration geographically.
Geographically or otherwise and then do you have reorders, yet or is it still kind of too early.
So I'll answer the second part first yes, we've seen reorders.
There is yes, I think the.
The first part of your question are we seeing any geographical adoption or concentrations geographically.
It's not been the case.
Where we're seeing our early orders, it's pretty much where there is interest or where there is early formulary access and so that's that's anywhere within the 26 territories that we have currently deployed.
Gotcha.
Okay. So my second question is about <unk>. So it is the intention for at home use similarly.
Episodic base.
I've been bipolar schizophrenia, or what are the goals of the phase one study given that we already have a good idea by the way. Thank you for a while.
Yes. This is Rob risinger the CMO.
The.
Major depressive disorder will be a daily dosing regimen.
It's not an as needed regimen.
So it will be taken in conjunction with their SaaS or SNRI serotonin or norepinephrine reuptake inhibitor.
And we know that.
<unk> 501.
Okay.
At least seven of the 17 items of the Hamilton Depression rating scale.
So we know for example, it will.
Prove or augment sleep.
And treat insomnia, that's three items on the scale. For example, we know that patients reported regardless of the illness. We studied they reported an improvement in anxiety, we know thats a major component of depression itself will be a daily regimen.
And that is the readout that we'll get from the daily dosing study what is the regimen.
Our people, what's the Tolerability if gives them again on a day or even a twice daily dosing.
So this is again our strategy to move the American staffing and it will be at home setting like our catering program.
Okay. Thank you.
Thank you AJ.
The next question is coming from your teams in Asia from Guggenheim Partners. Your line is now live.
Thank you too.
Two for me as well first one is on community could you just frame for us the expectation for that study is going to read out in the first half of 2023, what do you expect to show.
And then.
If you can maybe further elaborate a little bit on the MTBE side. It seems like you have completed dosing or dosing schedules.
Are you learning.
From the safety perspective, given it is more of a daily dosing dynamic we saw in him.
Just articulate that for us so far the money that you learn from the healthy volunteer studies.
Sure so.
I'll handle those in reverse that your last question first the study is ongoing the daily dosing study in healthy volunteers. The fact that it's ongoing and we continue to enroll cohorts testing greater and greater doses, it's an MA study or multiple ascending dose study means that it has been well tolerated we've not run into.
Stopping criteria, whereby you would not dose the next.
Scheduled cohort. So we have tested a range of doses and continue to escalate. We've not reached what is commonly called a maximum tolerated dose.
And I view that as a very positive thing.
The study when it will read out is when we finally have a maximum tolerated dose when we reach that point, we will then be testing it in conjunction with an SNRI.
And that will then enable.
The trial and are a proof of concept trial in major depression.
So turning now to your first question about tranquility the Readouts for the tranquility to study will be very similar to what we reported for tranquility won the primary efficacy measure is the change from baseline in the Pan's excitatory component at two hours. After the first dose we have repeated dosing.
So we will report.
About the safety and Tolerability of both first dose and every dose that they may receive whenever they have an episode of agitation over that three month period.
We will also be reporting some of the efficacy measures that are secondary or.
Exploratory for example, the Pittsburgh agitation scale.
And clinical global improvement.
And so those will be what we should be able to report in the first half of 'twenty three.
So just.
To add to what Rob said it is pretty much is similar to what we have seen in tranquility, one which form the basis for our breakthrough therapy designation with the FDA. So.
Pretty much everything is safe.
Same except here, we are following up with three more months after plus dosing of each patient.
Thank you.
Okay.
Thank you good luck. Thank you.
Thank you. Our next question is coming from Greg <unk> from Mizuho Securities. Your line is now live.
Thank you good morning.
And congratulations on the progress I did have a question just on.
What's your reporting for sales and certainly you have been.
M <unk>.
Telegraphing for some time that it would be slow and gradual I think perhaps this might have been a bit slower than we were anticipating so.
As we think about the fourth quarter and perhaps into 2023.
Should the expectation be that it will be.
Kind of similar to this and then there's a kind of inflection maybe after year. One just any color on how we should be thinking about the uptake curves and then I have a follow up thanks.
Yeah, So Greg, it's Matt I'll handle that one.
So.
As we mentioned our commercial day and reiterated again. This morning, we have over dozen formulary wins.
So.
The expectation of uptake after a formulary win.
Can you can kind of look back in the market research, we did that to see what that looks like but it's roughly 37 or so percent and emergency department.
And site physicians.
We expect to try our goal within the first six months or so post formulary approval. So I think things are falling in line in line based on those metrics.
We expect there will be a very nice acceleration in formulary approvals over the next couple of quarters and so we will see improving.
Improving metrics and true demand over that time keep in mind, we don't stock. The wholesalers. So we are doing a drop ship model directly to the hospitals. So there was no stocking inventory to be concerned with and we recorded this first quarter of revenue.
With 26 reps in the field.
We're in the midst of expanding that we will have 70 deployed by December one.
And we think that that's going to have a meaningful improvement and acceleration on all of these metrics.
So I don't know if thats helpful. In framing how you examine your uptake in your models, but.
I think that's how we think about it and certainly we feel really bullish about the early signs that we're seeing.
Thanks, Matt maybe.
My other question just has to do with them.
The 130.
7000, and the sales that you did in fact record.
By the math divide by 105, that's about 3500.
You know.
Strips and I guess the question is.
Those strips that were used were they.
But basically were purchased.
Through contracting or were there hospitals that bought them.
Using the WAC price I'm, just trying to understand the dynamics of the actual.
Films that were used.
Yeah. So so one of the GPO contracts came online.
Later in the third quarter. So a lot of those units would not have been impacted by that.
Contract. So you shouldnt really be thinking about too much gross to net deduction. There is some but you wouldn't expect a lot of those those contracts that would impact the <unk> a little bit more to really be in place in a fulsome way in Q3.
Okay. Thanks again.
Thanks, Greg.
Thank you. Our next question is coming from Rob <unk> from H C. Wainwright Your line is five.
Thank you can you hear me.
Yes, we can hear you.
So just two quick ones. Firstly I was wondering if you could comment on whether you expect inventory stocking to be a feature of any future channels label extension.
<unk> indications for <unk>.
Got me going forward, yes in other words, the absence of inventory stocking is a feature that is specific only to the initial approved indication.
And would not necessarily be applicable in the future and then the second question is with respect to the cadence of completion of enrollment in the ongoing clinical trials of fiber. One if you could just give us a sense of that and I know you've provided us with the timeline for announcement of topline data, but if you could just give us a sense of when you expect those.
Clinical programs to reach full enrollment that would be helpful. Thank you.
So hey, Robyn it's Matt so.
On the wholesaler stocking question for future indications.
Typically when you go into a retail setting you would go full line in the channel, which means that we would stop the wholesalers and there'd be some stock inventory there.
That is wholly dependent on whether we intend to use that traditional distribution model right now that is a good operating assumption.
And then secondarily for Alzheimers dementia, we'd have to cross that same bridge is it going to be in wholesale or is it going to be in specialty or some hybrid of each so I think as we get our market entry strategies.
In a more complete form how we can communicate that out to you at a later date, but.
If we go for retail.
Would expect to see that there'll be some wholesaler stocking in the distribution centers.
Good morning, Graeme regarding your other question about the clinical pause tranquility two is progressing on track as you can see we already had DSM meeting and that normally happens like venue.
Well advanced in your clinical trials.
So enrollment is progressing well.
<unk> indicated there are two components of the plus dosing patients are followed for three months. So we are well into that process and lots of patients have completed the three month period as well and we will provide guidance. Once we have the full enrollment as we reach that point in addition for.
That was for the tranquility to all of you wanted to add something on the <unk> III <unk> three we will be initiating before the end of this year serenity three recall is.
Similarly designed to surrounding one and two are pivotal trials, which enrolled in a matter of months, even during the peak of Covid.
Perhaps because of isolation.
But we have now opened enrollment in the <unk> three to both bipolar patients and patients with schizophrenia. So we believe we're using the same sites same design same radar.
This will be equally if not faster enrolling than our pivotal trials were.
And so we fully anticipated and are confident in reporting topline for serenity three in the first half of 2023.
Thank you.
Thank you Erin.
Thank you. Our next question is coming from <unk> <unk> from Canaccord Genuity. Your line is now live.
Hey, guys. This is Carlos speaking twice Mont a few questions from us.
Since our loans has any idea in voting.
He called me and any instances where hospitals that he has to move.
It's an advanced stage.
And another question.
Any potential obstacles that can delay the timing.
These schedules can willing decisions.
Maybe one last question.
As Deepak from patients on any feedback on patients self administration and potential difficulties.
As any caregiver.
Thank you.
So regarding your first question on <unk>.
Right now we have about 40000 of our targeted ads in process. So those are scheduled to vote, but we have not had votes yet.
To date, we have not had any negative response Friday and votes.
I did not Kyle get your second question. So I'll move to the third real quick and then maybe you can repeat it but patients.
<unk>.
We've only spoken to.
Hospital pharmacists that have observed some of the velocity with the gourmet and so the feedback that we're getting from them is that the drug is working as expected that the patients are able to take it and that we've seen some improvements in discharge time et cetera, and that it's well tolerated.
To the to the profile that we present.
I.
I haven't heard of any patient difficulty or anything like that from administration perspective. So what was your second question Kyle.
Yes.
Second question is any potential obstacles that could delay the timing.
Formulary decisions.
Well I mean, yes.
One of the things that our guest speaker at the commercial day expresses the Pnp committees handle a lot of things beyond just drug evaluation for formulary inclusion.
A lot of things and so.
Because the the agendas and schedule can change those are risks to getting formulary approval.
But we've seen a pretty good cadence of PMT committee's meeting assuming that they have quorum, we would expect to be reviewed and we believe that we put ourselves in position.
For positive formulary review.
Okay.
Thank you. Our next question is coming from Corinne Jenkins from Goldman Sachs. Your line is now live.
Yes, good morning, everyone.
Maybe just I'm, sorry, <unk> could you just share with us some of the powering assumptions, there, particularly given we know pretty well the dose dependent response with a call me.
Yes.
Sure.
We saw very consistent dose dependent response, and we compared for example, serenity one in patients with schizophrenia with 72 in patients with bipolar disorder and there is very little precious little difference in their response, so knowing that it's a very consistent response. The FDA has agreed that we can enroll both.
Patients with bipolar disorder or patients with schizophrenia in the trial, we have a total and <unk>.
Believe it is.
It's not on.
Controls because it will be very shortly but the N is much smaller than the serenity, one or two trials again, we know it's a very high effect size number needed to treat in the range of two or three so our total and is around 200.
And that gives us greater than 90% power to detect a difference from placebo.
In patients with schizophrenia or bipolar disorder.
Okay, and then on the <unk>.
<unk> three study just curious what are the gating factors that are shot standing between now and initiating that trial in December .
I think the.
Getting back that has been to make sure that tranquility too.
Can be completed on time and these are pretty much same seattle and like the.
Same site similar site pretty much.
<unk>.
Also gaining the experience and learning from tranquility to to make sure. We can deploy all of that Expedia and completely focused on <unk> III. When it does begin as I said bank alluded to is tailing off so otherwise there was no other gating factor Okay understood and then just what is <unk>.
For initiation in play with respect.
Trial Readouts is that kind of a two H 'twenty three idea or is there any reason to think it would be earlier beyond that.
I think once we have our first patient dose and we have good handle on the tranquility full enrollment than we will be able to provide a guidance on <unk> data readout when that data readout is expected, but as you can see size is pretty much similar to tranquility to and how long did it take to complete that.
<unk> two starting from first.
Patient dose, which was somewhere I don't mid may timeframe Yep makes sense. Thank you.
Thank you we reached end of our question and answer session I would like to turn the floor back over for any further or closing comments.
Yeah.
Thank you everyone for joining us today and for your interest in <unk> Therapeutics have a great day.
Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.