Q2 2020 Minerva Neurosciences Inc Earnings Call

<unk> is being webcast live on the investor sections of the numbers website at <unk>.

Robert Neurosciences Dot com.

As a reminder, today's call is being recorded I would now like turn the call over to William Boni, Vice President Investor Relations and corporate communications.

Please proceed.

Good morning, a press release with the company's second quarter 2020 financial results and business highlights.

Came available at 730 am eastern time today and can be found on the investor section of our website.

Our quarterly report on form 10-Q was also five electronically with the Securities and Exchange Commission. This morning, and can be found on the Fccs website at Www Dot FCC Dot Gov.

Joining me on the call today for Minerva or Dr., Remy Luthringer Executive Chairman and Chief Executive Officer, and Mr., Jeff race, Executive Vice President Chief Financial Officer, and Chief Business Officer.

Following our prepared remarks, we will open the call for Q anyway.

Before we begin I would like to remind you that today's discussion will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of the safe Harbor provisions under the private Securities Litigation Reform Act of 1995.

We caution that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated.

These forward looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption risk factors in our filings with the FCC.

Including our quarterly report on form 10-Q for the quarter ended June Thirtyth 2020.

Filed with the FCC on August 32020.

Any forward looking statements made on this call speak only as of today's date Monday August Threerd 2020, and the company disclaims any obligation to update any of these forward looking statements to reflect events or circumstances that occur after today's call except as required by.

Law.

I would now like to turn the call over to Remy Luthringer.

Thank you Bill and good morning, everyone.

Thanks for joining us I hope everybody is doing well.

Today, I will focus primarily on me nervous sleep products like Teradata, which recently completed since a double blind popped into phase three trial for the treatment of negative symptoms in patients suffering from schizophrenia.

The significant unmet medical need is the main reason why patients with schizophrenia surplus from diminished function.

Indeed places a huge burden of patients stuff on the lids and she has kept Houston.

Today, there's no approved treatment for negative symptoms and the United States.

Isn't that review holds a phase three data, which builds on the face to be tied to US one additional day time, yes compiled in Culberson Eurs. We continue to believe that's what determines that potentially could be the first dropped to pull negative symptoms directory and specifically.

After giving an update on what the Paragon I will also discuss a sense election program and our decision to opt out holds a cookie blossomed agreement with Janssen Pharmaceutica.

Today I would like to begin there's an update them get review stage up from the recent phase three trial called the parents.

The triangulating to those who supported terrorism, certainly tool and 64 big one overplayed weeks.

The study was carried out at about 60 clinical sites in the U.S., you up and he's right.

Bars, and 500 patients like 40 in the trial.

Holdings, a 12 week double blind phase patients from offers additional buying bonds extension period.

Treatment was probably parago on page 30 to 64.

On page report to over 300 patients Entergy extension molds and one of these patients had no completed sequel broke one year treatment period.

Most of that appears to be bolts, it's only a limited number of patients opens the study as a result affords me positive symptoms.

Just continues to be observed to date in the nine months' extension.

So what have we loved about multi peril demonstrates a clean up I'm just trying to supply.

Statistically significant differences will absorb the primary endpoint that make us troops called propose ice tea module and the surface negative symptoms trucks is cool extracted from sometimes true. It you now keep building and placebo at week four but we're still she's had big age 64 bit example.

Most books receding active treat can show numerically superior performance and SFS two placebo to be twice.

What sorts of placebo improvement this higher sponsored phase three trial comparisons a phase to be trials.

He believes this may be why statistical significance was not achieved at week 20.

Functional improvement as measured by the person that essentially performance K.P.S.P. was statistically significant because she is a real leads the 64 big lump those at all process leaks.

No one knows P value oxymorphone see what 21 pitch we twin.

We continue to explore as a driver behind pool mother negative symptoms and consequently functionality.

Are you looking like it's called a woman.

Negative symptoms and we suspect it is largely driven by a meaningful improvement the patients not enough obligation well luck interest for engagement in go look on that could be paper.

So what is next.

Once we complete I want additional analysis owns the phase three data, we will be requesting a meeting with FDA to discuss our data package on deposits for work.

And then see Blackman.

I wouldn't like to address I'm, a second clinical stage program sent direct sent me into it too.

On July 1st consultant 20, we announced that meets a size a light to college football rights agreement. This young symptoms of should get block in the sense of Rex.

As a result, nobody collect royalties the mid single digits burst watch sales sense direction.

All indications with no financial obligations to down some moving forward.

So that you're going to opt outs you agreement that you started <unk> program enables us to retain a meaningful financial interest in the future revenue stream well, if a company significant commercial potential invincible indications.

It's the same time, he doesn't mean age the company's obligation to make significance and then should pay much it's fun to watch phase three program.

Oh this even I'll talk to me that enable us to align probably jumana tremendous resources, our primary focus to seek approval will probably come from terrorism and to help.

Patients for reach so certainly no effective treatment.

Before handing over to Jeff to good use of financial update would like to restate our conviction simply that paradigm has significant potential.

He is a first rock approved to treat negative symptoms.

Conviction is based on other growing up the stands with negative symptoms and the recent phase three data combined.

As a day jobs that we had accumulated over the past few yards.

Do you think ranging data combined with the basic mechanism affection and federal saying people fun gives us confidence the future body paradigm.

Well if there was only mentioned important program, both as a potential benefit to patients tend to families and the significant commercial but you did she to effectively treat negative symptoms.

It's a friend and beyond.

I would know toward me to over to Jeff.

Thank you Rami.

Earlier. This morning, we issued a press release summarizing all operating results for the second quarter ended June Thirtyth 2020.

More detailed discussion of our results may be found in our quarterly report on form 10-Q filed with the FCC earlier today.

Cash cash equivalents restricted cash and marketable securities as of June 17th 2020 were approximately $35.3 million.

We present, the expect out the company's existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements into early 2022 based on our current operating plan.

The assumptions upon which this estimate is based are routinely evaluated and may be subject to change.

Research and development expenses were $5.8 million in the second quarter of 2020 compared to $8.3 million in the second quarter 2019.

For the six month ended June Thirtyth, 2020, R&D expenses were $13.8 million compared to $19.9 million, but the six months ended June 32019.

The decreases in R&D expenses during the quarter on six months ended June 32020, primarily reflect lower development expenses for the phase three clinical trial of Rowley paradigm and the phase to be clinical trial of men walks seven.

We expect R&D expenses to decrease during 2020 as we have completed the men long long seven clinical trial and the 12 week double blind portion of the phase three clinical trial of Romney paradigm.

General and administrative expenses were $5.9 million in the second quarter of 2020 compared to $4.6 million then the second quarter 2019.

For the six months ended June Thirtyth, 2020, DNA expenses were $10.1 million compared to $9.3 million for the same period in 2019.

The increases in Gionee expenses during the quarter on six months ended June Thirtyth 2020, what primarily due to increases in noncash stock based compensation expenses and severance benefits.

Net income was $29.5 million for the second quarter 2020, or net income per share of 75 cents and 73 cents basic and diluted respectively.

As compared to a net loss of $12.5 million or a loss per share of 32 cents basic and diluted for the second quarter 2019.

Net income was $17.4 million for the first six months in 2020, well net income per share 44 cents and 43 cents basic and diluted respectively as compared to a net loss of $28.3 million or a loss per share I've said.

73 cents basic and diluted for the first six months, but 2009 tea.

As a result opting out to the agreement with young from the company recognized $41.2 million and collaborative revenue during the second quarter 2020, which had previously been included on the balance sheet under deferred revenue.

This amount represents the 30 million dollar payment made by young person in 2017, and 11.2 million in previously accrued collaborative expenses, but given by young some upon the effective date of the amendment.

The company does not have any future performance obligations under the agreement and we'll recognize any future royalty revenues in the periods of the sale of products related to the agreement.

Now I'd like to turn the call either to the operator for any questions.

Operator.

Ladies and gentlemen, if you ever question or comment at this time. Please press the star than the one Ci on your Touchtone telephone. If your question. That's been answered you were seeing yourself from the Q. Please press the pound tea.

Our first question comes from a job you need with Citi.

Hi, This is Sean Egan, calling in for Joel. Thank you for taking my questions.

A few for me today, maybe little bit more on your decision topped out of the filter Roxanne program. Why you think that was the right decision at the time can you provide any color on whether yes, if they'll find to evolve this asset going forward.

Another follow up question on well you've heard overall.

So thank you for the question so really speaking so so clearly I mean, oh I see exists.

But each of these are very interesting Marty killed the very.

Potent molecule and obviously, we cannot speaking for young some blessings this isn't really a.

Project, which is really moving forward and I really hope that this more because he's going to patients who need just kind of treatment.

I was the first part comes a question maybe Jeff you can take it away the we opted out.

Yes. Thanks for the question Sean the decision to opt out was really based on a return on investment a decision we were looking at the.

The the benefits of this program the European rights that we we had a as part of all agreement with young person on the on the royalty rate compared to the size of the investment that we would have to make into phase three program and we felt that it was a better we turned from another on that show hold.

Just to opt out of the programming and take the smaller royalty has described bye bye.

By Remy and his updates earlier today.

Perfect. Thank you and then on all your pared down Holland, one do you plan to share kind of the additional details of the phase three publication and what I guess when that is presented what are the most important data metrics for investors to be kinda zeroing on them.

So it's obviously a great question and a well. It's a question we are getting a quite often outside so what I can say about but this is up I mean, we have really done a lot tougher additional analysis.

Hi, you eluded to this in my email Coke just before you buy my uptake just before clearly I mean, the or even if we did not a heat a P value at week 12.

Or is a data we heavy turns and old traditional that lets see social things that I mean as this translates into a functional improvement there was a patients.

I also hinted to treat a it's clear that like interface to be a Z abolition or improvement is agreed is a key driver remember being a publication from Gregory stroll showings at.

Improvement the foundation was our most recent right to improve.

Overall negative symptoms and that's a consequence.

PSP and.

At the end of today's how's that patients a functioning. So all this whole just oh. This is maybe fitting together and owns a under these isn't that doing is fitting together.

Not to give you a complete update the results would be titles Oh I don't know when do we do this but I think the most important countries that we already preparing and be ready for the.

Meeting with the FDA, so people that should meet those requests for meeting.

The next coming days, though.

Because we have no oh is a date on most of the data together, it's not and lots of two to fine tune on this and the things a best moment to keep busy update is to have obviously the outcome of course I mean, that's from the yes, but but I think.

So bottom line is at a more and more convinced that you struck a ease of doing what had to do it's clear that in the phase three we had this.

Second placebo, which was a which was more Republicans and interface to be and are expected to clean up the surprise us because if you have a highly positive the.

Face to be study or you know the expectation from a P. I used that as a side. So then devens a patients or is it can leverage higher.

This is obviously one explanation of B. We obviously went from sort of decides to 60 sites and this has also an impact but overall when you're looking to sell drugs again tools, a functional consequence season and from wireless defect is coming.

I will nation.

He is an innovative mechanism affection I'm very confident that could have a good meeting with FDA and so this is probably aren't what they can take you out as of today.

Thank you or anything.

Our next question comes from burn a mini with Jefferies.

Yes, Hi, good morning, guys. This is a geet on for Baron Thanks for taking our question, maybe just to from US Rami I guess, it looks like you're going to be scheduling. This meeting with the FDA and the next couple of days any idea of when that meeting like perhaps take place and one youre come back with the feedback in hand.

And second or do you believe the F.D.A., maybe willing to accept post hoc analysis data and are there any examples of the FDA accepting such data in the nearest like space for regulatory approval. Thank you.

So so concerning the timing of the see Uh huh.

If we submitted as a as a document a very soon which will be the case.

Usually I mean, those are tied back to get a meeting granted these 60 or 75 days, depending on what type of meeting your will ask for us. So so so definitely we will have a oh to say that meeting and the feedback hearings.

The last quarter of Oh end of them as a CIRCOR, just sorry, and we might get a feedback a one I'm on slide to since third quarter meeting.

And the feedback one months later so this is a.

Perfect life, I don't know lucky's impact off Colgate and as a meeting since you have GE has visa sponsors, but what I heard that make him I'm, just saying sorry, I'm truck comes yesterday.

With respect seems a timetable so again.

Meeting is that in Q3 and feedback afterwards, when we have some minutes.

Concerning your question I mean, I think I think I'm or Pakedge is not only based on on post Doc analysis. Obviously, we have done a lot of post talk analysis, Oh, you notice to better understand definitely examples of placebo behavior. We have done that obviously some post Doc analysis in order to better quantify.

For example, the effect on my P.S.P.S. not to see if somebody in a PSP and negative symptoms improvements OCO related to ease abolition a driver all what I was speaking about the before so but the or is he sees a it's just confirming some oh and that is this which was kids.

I didn't see just statistical analysis plan, which has been submitted to the FDA before we did supposed to look at how does he said before obviously is a data came out with his arms. The opening of the blind. So I think we have you know were package quite a lot. So oh I know these this which has been done not possible, but a priority, which hopefully will come in says.

The FDA.

I'd say Oh I think there are some examples maybe noted the ins and CNS pace, but that means out some examples where.

You know the FDA was giving as a green light a too 'cause a sponsor to move forward.

Based on or not a absolutely a P value and so on the primary endpoint than some additional color.

Which ones even by cost look I'm not easy. So so again I think we have.

I Love you know what data again, I'm, not saying that the that she achieves a primary endpoint at week 12, definitely not but what was the rest of the data pointing towards a fun. So the Modi cold is working that's a things are extremely similar to the to the phase to be again.

Remember I showed you a combination outside of the two studies this will not be.

Some things you have good we consider but it will help but again long story short classic we have enough a primary analysis, which hopefully we can means you have to.

Appreciate the color. Thank you.

Our next question crush on Tom Shrader would be TRG.

Hi, Good morning. This is drilling on for Tom Thanks for taking her questions first just keeping in mind. It's still early can you, possibly talk about what an additional phase three study perrella pared down would likely look like if that's ultimately in your best interest would it likely just be one dosing, we expect to a shorter study duration or any other gift.

Yes, as you could comment on that's fine.

So first of all the again I mean, Oh I was a company and personally know having having really boarding full this molecule from.

From the beginning and ER and try really to address unmet medical need them, but I think this is an important work together he ever you're dealing with what was it was <unk>.

Unmet medical need which has no treatment and dishes what he is a really.

Making sense. These patients are not able to get the any decent life and don't know functioning as a family lifestyle or even not speaking about forgetting is a small jumped this which which obviously he's a would be on some very important so but again I really I really think that Ccs is really.

What is right what is driving S and.

And I guess, sorry, I I would be so we see on can you repeat your question Justin I can be there's a write down so that's.

Yeah sure. So perhaps after you reconvene with the F.D.A., if it's higher I started eating.

Can you hear me.

Yeah.

So it after that meeting it's in your best interest to proceed with an additional phase three study can you give us a sense for what that would likely look like compared to the most recently concluded one.

We are likely to be one dose it whether it be a short duration things like that.

So what they wanted to say, yes, basically no sorry.

Well they wanted to say that I mean, obviously, it's a best Saudi or if we have to do I study.

I would be took always one those are definitely see Oh no extension like in this study is always a phase three study we just completed.

Because as you heard me will accumulate a lot of data in terms of extension and this would be very positive D. Thompson also having some efficacy measurements and we already knows that things are going very why didn't you extension. So so this definitely will be a study result, an extension so to do one dose of course placebo definitely do you know to do this.

But what I wanted to say this is the reason why I started with explaining.

Negative symptoms so sector.

Obligations of driver, we would love to see the discussed with the FDA if we have.

To do a study.

We will discuss what is the best the primary endpoint, but these are way to calculate the negative symptoms and how do we extract.

Ah functionally I think we did the right things I think it's a it's clear that I mean negative symptoms is a construct off for a different sops core sounds you know what means a consensus today is that the negative symptoms easy centsfive a abolition on Indonesia.

Oh this is part of that negative symptoms constructs.

And you know works or that I mean, it is well accepted jets a zero modeling they got to score can be subdivided into too.

Hi, Tim. So these are two dimensions experience an expression and remember here, we had the music experience we had a highly significant P values. There. So it's I think that we'd be a discussion if we have to do a study about what is the best primary and what is the best secondary endpoint, but I think yes, you're right.

It would be much smaller study much more straightforward study, but what would be tranches. So bad because you asked fields. As his question I think what people change is definitely a reduce the number of sites.

Because I think what's happened to just phase threes at me.

We really were able to you know to two in brackets controls the sites all trains ascites vary widely but I mean, maybe one or two sides steep not completely dueser, scoring how's it should have done just corey.

So we would reduce the number of sites and do you have I'm still not inside the how's the sites have performed because we have the well. It's a completed the analysis up to 60 sites, who have participated as this study we have also.

We went back because the analysis of holds the sites. So decides what participated as a face to be so so this would be the first seem to have really.

As of right sites.

Who really create as he said.

Motivation by just sites to to reduce cost of patients no teams, a context, but a brady's core symptoms of patients because they see the essence of having a separation from placebo.

Or is this will be a criteria a little bit implement in order to to make sure. It doesn't mean that had a successful study undiscriminating placebo from a treatment.

Okay got it. Thanks, that's very helpful. And then last the on felt Rx and are you aware of any plans at this time for development and the broader insomnia market beyond major depressive disorder with Cormark cargo bid a insomnia is that something you have any visibility on.

Well I think we ask you heard me on outcomes Oh, There's a program and the we took on the royalties.

Keep in mind, what that means a patient populations MDD population, who will be included in this phase three program run, but young sung ji.

These are patients who have but complained of insomnia, but as you know in some ways a big driver depression, but I mean, it's going a little bit beyond this because oh the in some yelp, we'd be characterized NZ added you'd be ditched trajectory of the patients but in addition in something that will also be quantified subjectivity.

Objectively during the trials. So so I think did some difficulties already covered to even though the trial or just trials, which we'd be run degree C and D D population.

Okay, great. Thanks very much.

Again, ladies and gentlemen, if your question or comment at this time. Please press the star them a one key on your touched on telephone.

Our next question comes from Jason Butler JMP Securities.

Hi, Thanks for taking the question just a quick one for me.

Wondering how you think about.

Partnering priorities for all the pair down now with the state or on hand, either in the U.S. or in other other global territories is it more of a priority or are there things that you would consider or.

Have you already started any discussions thanks.

Oh, so jayson I, maybe able to give all but two so jeff hidden in a minute, but I think as we discussed already in the past them and we have always been a open to discuss squeeze a we've seen bones, we got from pharma companies. So so as you as you know I mean, you can guess.

Another pharma companies are complete you're aware about the only paradigms that people up and we have done so, but that's a and we continue obviously to the gives them as the updates eat a brief updates on our asked for us, but maybe Jeff you want to give more color on this.

Thanks for the question, Jason that there isn't really much more to add to that we will have a discussion with the FDA, which should provide additional information to potential partners and.

We'll have those discussions are at that point in time.

Okay, great. Thank you.

Our next question comes from mild winter with William Blair.

Hi, guys. Thanks for the questions just the first one on the potential differences between the placebo response in the size to pay in the phase three.

The tied to for a little talking now I'm, just wondering whether there's anything that's coming up in this additional tighter analysis that really point to the reasons why you would have seen a defense insect religious the difference in the quality of the clinical thoughts that you alluded to Remy that mark.

Describing that floor is this something else in the patient demographics that it coming off I Arnie off because this is obviously something.

You're going to be formulated and argument.

DFT I about so just wondering any additional color as to the specific reasons why that differential response that occurred.

Yeah. So this is obviously a great question as it can.

Guess I mean, we've worked a lot clumsy systems I think we have a clear understanding of Oh for TEP and SMB now I was mentioning a.

Quality off of scoring of some side some of them indefinitely and be read knows what that means he says.

Has an influence on the data, but I think what he was also mentioned they got the expectation after a positive studies.

Is increasing clearly the patients who had been included into studies in terms of.

I chose takes in terms of leveled off negative symptoms Uh huh.

Duration will offer some negative symptoms even stability trends are positive symptoms has definitely not a change between the two studies. So so suddenly really I think is basically a several things again the expectation of having a.

Uh huh.

Important studied hand, which has shown a very key or any sense on negative symptoms, which has an influence on how's the signs of scoring.

There is another aspect, which is important is that during the study and a and B has no. Several reports from sites about patients who have dramatically improved into our best work.

Which obviously we will.

And I wouldn't be are going to see because you have GA because so really is a sites could see that's everybody proven to upsize. The patience. She brings a course also announced a 12 week Tupper blind phase.

So I was a towards the end of the study or towards the end of the recruitment just willingness to push as a patients to the extension because here. Obviously you know isn't just treated with 32 milligram of 64 milligram. So there are lots of things, which are which I explaining.

Why why we had just.

What I call inflation also oh from the tough for a placebo arm.

I think the most important dr. Robert data and I see this is something which would be that'd be helpful. You wouldn't be are going to two to present, those isa and what you've been put obviously, it's a briefing book, that's all what you'd be willing to present as you have gaze too so really show and demonstrates that between the phase to be into phase three.

This improvement we have seen with ER with a 32 and more practical Ali we 64 meeting room is the same between the two studies.

We will regain demonstrate that abolitionism extremely important driver and here so seeing some very very clear when you're looking for the data we have today and and obviously were below so more and more going through the details about the psps, which doesn't always a functional deeper.

So all these pieces are fitting extremely well together and or are definitely not influenced as they have been I use a placebo effect on plays a placebo inflation, causing the primary endpoint has been in France, and you know, it's what the RIDEA surprise, because as I tried to explain before.

Negative symptoms is a construct of different aspects and different dimensions, and what you're going more into the details with you see that them in a phase threes are extremely positive Andes discriminating Mary while treatment from placebo 'cause this would be the <unk>.

As a full pakedge, we will present to the FDA.

That's helpful. One final one from maybe.

Just incentive to small amount of patients that have discontinued the art gun life extension study to do positive shaped and right last maybe in a real well perspective, what they tysons just got on adjunctive therapy, we stuck may receptor blockers and that didn't manage their or whether it's something specific in nice patients that they must be which.

Drawn from roll the paradigm treatment.

I think there's nothing specific here et cetera.

Coming to your question about I've done NASA as I was nothing specific because I mean keep in mind share that Oh, we have included or.

More than 500 patients I'd be I've read you handful of patients who are our relapsing ends the he's a double blind phase and.

That was a handful or in the extension. So so when you're looking to the trials, which had been run at least antipsychotics I mean.

Whatever your take as an antipsychotic first and second generation.

When the trials are run over appeared to four to six weeks. It have you had the people who are not responding all what relapsing on positive symptoms. So.

So the number of relapses, we see is really in line with what you're seeing please with antipsychotics us. So so I think all the data would be extremely helpful. For short was a to Z to the FDA or two zero, because the CHF p. or two in Europe, but I mean.

You can have a significant amount of patience, we the diagnostic of schizophrenia do not absolutely need ondeck psychotics in order to stay stable just himself of positive symptoms.

No.

There was your question about Adama as you know and we discussed nations past, we we have a review of 150 Upcycle Christians a in the U.S. and the based on Z target product profile you have already a significant amount of these prescribers who are willing to gives a drop in piedmont to sell.

Pete obviously some of them will steal a go I don't think because this is clinical practice and the and it will be take maybe a little bit time to convince that some prescribers and patients out there who do not need antipsychotics, but but that seems a field is evolving quite significantly and.

As Oh, so we discussed in the past.

No very very good publications out showings at.

You can reduce very dramatically that those this upon deep psychotic sends a number of Philips this will not will not.

Increase so I think as a stories coming together, but again.

As a data we have been send our really showings at a.

A lot of patients do not relapse, and remember, which is a wouldn't be when you're going reasonably inclusion exclusion criteria. This represents 60% to 70% of the patients. These are diagnostic of schizophrenia NASA. So so they're not the speaking here about the marginal population. The speaking with a very very large prospects of patients. We said if not because kids so again.

Long story short.

It will need a little bit time, it will lead to little bit education, but I.

I think.

We have here and rock, which is really improving negative symptoms and functioning and I'm still.

I believe and this was my hike with Taser is a longer long long time ago. When I started this project.

When you're improving negative seem so maybe negative symptoms and functioning you probably also improving.

Positive symptoms or at minimum number of hospitalization slash relapse, it's because of patients is more able to co president everyday life science. So so it's a it's a it's a paradigm shift it is obviously going through a multi killed which has led side effects, which is less imperatives of patients.

A bridge.

Is a really having especially effect on negative symptoms and functioning. So good tiger will take a little bit time to educators that prescriber, but that seems a field is maybe moving into the right direction.

Fantastic Thanks for the questions.

You're welcome.

Our next question comes from Douglas Tsao H.C. Wainwright.

Hi, good morning, Thanks for taking the questions just a couple for me.

How are you now sort of thinking about are prioritizing some of his sort of subsequent work that we.

Youre considering in terms of the ability to sort of.

Prevent onset of the disease or sort of treating patients and the pro terminal phase as well as you know just now prioritizing resources in terms of some of his other assets in the pipeline and or is it you guys sort of for the time being just really focusing on getting roll the paradigm to cross the finish line. Thank you.

Your line muted Remy.

It's still showing only blackrock.

[noise] Oh, what can you hear me now.

Yes, I mean.

Sorry, sorry, the so so clearly clearly.

Your first question about you know going for example to prodromal patience I want to put the roadmap to sit to subject to have the negative symptoms that you might transforming to a full blown.

Psychotic de sees the schizophrenia for example.

This is still feel that something we absolutely want to do yes because.

Things at the order data, we have Oh showings at I mean, if you contingencies.

Mike maybe avoid to patients who are already having a full blown disease.

And if they have some negative symptoms.

Before they have the first step you know the positive symptoms. So clearly this is something we are working on but this will be done post approval because as this is a very specific study and don't so a study which needs the right subjecting the study, but I mean, yes, I think earlier is better in our case.

It's schizophrenia.

No concerning the other assets, we have a seasonally highest priorities here I'm going to paradigm.

We need to have a very.

Very good outcome receive FDA and based on a positive outcome 60 other assets can regain start to move according to plan, yes, but that means the highest priority is to.

To make sure that gives the best outcome from a from the FDA and sorry about this technical issue I was definitely a muted [noise].

Oh no worry.

Yes.

And I'm not showing any further questions at this time.

Okay. Thank your for further questions and ER and hopefully it was helpful. We obviously looking forward to to update you.

Very soon about the progress we have made them and things that makes the major key then said we'd bcf data about what do you have used setting us up based on the data will provide to them. So thank you again I'm looking forward to give you updates very soon thank you weren't.

Ladies and gentlemen screen close todays presentation. Thank you once again for your participation you may now disconnect have a great day.