Q4 2019 Earnings Call
Welcome to them and there's no sciences, <unk> and 2019 conference call.
This time, all participants I know listen only mode. There will be question and answer session. Following today's prepared remarks.
This call is being webcast lies on the investor section of the nervous website at <unk> Dot Minerva Neurosciences Dot com.
As a reminder, today's call is being recorded.
I'd now like to turn the call over to William Boni, Vice President of Investor Relations and corporate communications at Minerva. Please proceed.
Good morning, a press release with the company's yearend 2019 financial results and business highlights became available at 730, I am eastern time today and can be.
Found on the Investor section of our website.
Our annual report on form 10-K was also filed electronically with the Securities and Exchange Commission. This morning, and can be found on the Fccs website at Www Dot SCC Dot Gov.
Joining me on the call today from a nerve are Dr., Remy Luthringer executive Chairman and Chief Executive Officer, Mr., Rick Russell, President and Mr., Jeff raise executive Vice President Chief Financial Officer, and Chief Business Officer.
Following our prepared remarks, we will open the call for Q and <unk>.
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 detail.
Under the caption risk factors in our filings with the FCC, including our annual report on form 10-K for the year ended December 31st 2019 filed with the FCC on March nine 2019 any forward looking statements made on this call speak.
Only as of today's date Monday March nine 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 today.
Me nervous mission is to develop innovative therapies to meet significant unmet medical need faced by patients suffering with schizophrenia depression sleep disorders, and your degenerative disorders, such as Parkinson's disease.
Last year, we took significant steps to achieving our goals.
I'm pleased to report that 2019 was a landmark your for Menorah as we read out positive data in three phase to be studies, we set the wrexham in patients with MD and insomnia.
In addition, we made great progress in recruiting over 500 patients into the phase three study was really paradigm. Meanwhile, the one.
And we were delighted to announce completion of enrollment in early February.
I'm looking forward to announcing top line results are brought impairment on study into second quarter of this year.
We believe this results has the potential to transform the therapeutic landscape for schizophrenia.
Recently, a number of eminent researchers have highlighted told rolling paradigm, if approved could successfully treat a significant percentage of patients for schizophrenia suffering from negative symptoms and cognitive impairment.
Among emerging Sarah Appeasing development for negative symptoms voluntary done is the most clinically advanced.
So best of our knowledge wrote a paradigm is the only therapy, having shown today, especially if he can direct improvement of negative symptoms interestingly frozen data analysis of ever faced to be study showed that patients also improve in terms of cognition mood and functioning SUS further demonstrating.
What we believe ours, a unique qualities of the Sargent.
Last month, we announced the completion of enrollment in the ongoing pilots or phase three trial. It was repair we don't as monotherapy for the treatment of negative symptoms in patients diagnosed with schizophrenia.
Finally total of 515 patients have been on road compared to our original goal of 501 patients.
So trial, which is being conducted at clinical sites in the U.S. and Europe is a randomized double blind pilot group placebo controlled 12 week study to evaluate the efficacy and safety of 32 milligram and 64 milligram doses afforded paradigm as measured by is a positive and negative syndromes Kay.
The primary endpoint is a milder negative symptoms factor score secondary endpoints includes a personal and social performance came and clinical global impression of severity.
Patients are being randomized one to one to one it was a search he told me to Graham and 64 milligram doses afforded paradigm and placebo.
So core 12 week double blind phase of the trial is followed by your 40 week open label extension period during which patients on drug hefty option to continue receiving is that region of dose and patients with placebo may receive one of the two doses of wrote a paradigm.
Topline results for is a 12 week double blind portion of the trial are expected in the second quarter of 2020.
An intensified focus on negative symptoms has emerged indicate where community since the results of the royalty paid on phase to be trial were announced and since the phase three trial was initiated.
A total of seven peer reviewed publications have been published since our phase to be data became available showing the unique unspecific effect of ready paradigm on improving negative symptoms and effect that translates into both cognitive improvements and functional improvements.
Most recently for example, we hosted a care well breakfast last week during which research and talking to Gregory's trials discussed. His recent study published in schizophrenia ability.
Results for network analysis of our phase to be data is roughly Perry done by Dr. straws team showed that the successful treatment of the core negative symptom of abolition defined as reductions in the desire for and initiation of motivated behavior is a key driver of the overall improvement of as a negative.
If symptoms of schizophrenia.
We believe that negative symptoms are a feature of a number of neuropsychiatric disorders that may be attractive targets for the future trends diagnostic clinical development before the paradigm.
And we have recently filed an eye indeed to prepare for a clinical study for the treatment of apathy in dementia.
I would like to move onto sent directs and our second clinical stage product and the development with Janssen Pharmaceutica for the treatment of insomnia disorder, and major depressive disorder MDD.
During 2019, we announced positive data read outs of three phase to be trials and one phase one be trial, we set directions three of these trials, where a major depressive disorder mbd and one was in insomnia disorder.
No not shows the results shows itself direct Sun has positive effects on in some patients without comorbidity, including elderly patients with a favorable safety profile in MDD patients not responding to the equated to essence arise and isn't the rise sell direct some also shows improvements in mood, particularly in patients with insomnia.
We announced in the currently discussions regarding phase three strategic development with a target indication of adjunctive treatment of MDD.
He discussions include development strategy and financial considerations related to the phase three program and the timing of payments following the achievement of defined milestones under our agreement.
We had Johnson are also currently consulting with the U.S. food and drug administration, FDA and the European Medicines Agency EMEA.
Well just target indication. We recently attended the end the faced a meeting with FDA to discuss the design of Phase three studies and we expect to share details related to these studies later this year.
Finally, we are making significant progress into preclinical development of Min 301, Soderbergh recombinant form of the Neuregulin one bit of one or energy one be to one protein for the treatment of Parkinson's disease and the other neurodegenerative disorders.
We believe means for your one has a potential to target brain deficits and in so doing two slows the onset off and restores the brain tissue damage caused by this neurodegenerative diseases.
Preclinical toxicology and Houser I, India, enabling studies are ongoing.
Paintings that completion, we anticipate submitting regulatory filings in the us or you work.
Is that if approved we lost to move to exist compound forward into men.
We believe 2019 was an overall success based on several repair ever done and set direct summed achievements I have described.
So completion of patient enrollment marks a major milestone into phase three trial with repairing them.
We'd like once more to sank all the patients clinical investigators external consultants ends of Minerva clinical team conducted and participated in this trial.
Results, our commitment we would not be standing as a threshold of potentially transformative data readout in the coming months.
I'll turn it over to Jeff.
Thank you Remy.
Earlier. This morning, we issued a press release summarizing our operating results for the fourth quarter and year ended December 31st 2019.
A more detailed discussion of our results maybe found in our quarterly report on form 10-K filed with the FCC earlier today.
Cash cash equivalents restricted cash and marketable securities as of December 31st 2019 were approximately $46 million compared to $88.1 billion as at December 31st 2018.
We presently expect that the company's existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months from today I did to mid 2021 based on our current operating plan the assumptions upon which this estimate is based are routinely evaluated and may be subject.
Change.
Research and development expenses were $28.5 million in the fourth quarter of 2019 compared to $9 million in the fourth quarter 2000, a day seat.
R&D expenses, what $68.1 million.
For the year ended December 31st 2019, compared to $34.9 billion for the year ended December 31st 2018.
The increase in R&D expenses during the fourth quarter and the year ended December 31st 2019, primarily reflects a 19 million dollar non cash impairment expense for the discontinued developments of Min 117 at higher development expenses for the phase three clinical trial of Rowley paradigm.
On the phase to be clinical trial of mid 117.
General and administrative expenses were $3.8 million in the fourth quarter 2019, compared to $4.6 million in the fourth quarter 2018.
DNA expenses were $17.7 million for the year ended December 31st 2019.
Tied to $16.8 million for the year ended December 31st 2018.
This increase in DNA expenses during the fourth quarter on the year ended December 31st 2019 was primarily due to an increase in noncash stock based compensation expenses and higher professional fees to support precommercial activities.
Net loss was $29.9 million for the fourth quarter of 2019 or loss per share of 77 cents basic and diluted compared to net loss of $13.2 million for the fourth quarter of 2018 or loss per share of 34 cents basic and diluted.
Net loss was $72.2 million for the year ended December 31st 2019 or loss per share of $1.85 cents basic and diluted compared to a net loss of $50.2 million or loss per share of $1.29 cents.
Basic and diluted for the year ended December 31st 2000 that 18.
Now I'd like to turn the call over to the operator for any questions.
Thank you as a reminder to ask a question you wanted to press star one on your telephone to withdraw your question press. The pound key please standby will be compiled the candy roster.
Our first question comes from Jason Butler with JMP Securities. Your line is now open.
Hi, Thanks for taking my question.
Just wanted to revisit one of the discussion topic from your Kalo then on Friday.
Henshall for I wrote down in other indications the involved negative symptoms can you just maybe speak to how the different components of the big assessments of negative symptoms that may read through to other indications and how you think roll apparel down could impact both those components. Thanks.
Hello, gentlemen, Remy speaking, yes, so obviously.
Great question SMB and.
I think it was a very interesting discussion during this event this but so.
Clearly I mean, I think what these Sean.
Literature is that.
In addition is definitely a driver lots of conditions. This I mean people lose exists and drive and this ability to get involved in any activities is really a key driver. So so really I mean as there are lots of data in favor of having our directly working in other indications when you're looking also.
To some work which has been done for example, or even.
In depression, our EG mood disorders compared to patients age kids afraid know is negative symptoms you see the same branch structures basically.
To date itself. So there is really a common Pos between what you see eating that schizophrenia and depression. For example, so I'm not saying that you just completely overlapping but I think there is a common Pos into I think last but not least and we didn't have discussed extensively number.
Yeah. What event is that I think really are done has affections to be RIDEA effective in other indications like.
Neurodegenerative disorders like out similar Parkinson's disease because.
Remember we have this extremely significant decrease of bdnf, GNS, which is definitely helping in terms of.
Neuroplasticity and and May be newer restoration, yes. So so when you put all the pieces together.
I think a lot depends on can be really seen has a very trends deterministic.
Molecule not only for negative symptoms, but also for cognition probably.
And as if we if you remember is a very early days that we had seen effects on sleep. So when you put those together I think we can be extremely confident that it works on so in other indications.
Okay great.
Then just one more for me in terms of the Nonclinical components of the NDA submission.
Hey, good where you are in things like see the CMC component BMD area and.
The nonclinical preclinical portions and is there anything other than the clinical component of the submission that would be time gating. Following five phase three results to Andy a submission. Thanks.
Yes. So the short answer is a there is no limiting factor is because we are extremely advanced in the in preparation of the NJ filing and obviously, we need to have the clinical data, yes, but for the rest them into things I really moving according to plan, we are extremely well advanced Oh in terms of.
CMC.
We did a very very very careful review what was a preclinical data.
We have even.
Because some data.
The guidelines have changed over time, so we have repeated some data.
To be according to the to the most recent guidelines. So so I think.
I can't say this very low than tier.
You are ready outside obviously waiting for the clinical data.
Great. Thank you for taking my questions and where we're excited to see the data soon thanks.
Thank you Jason.
Thank you Sir our next question comes from Douglas Tsao with Sealand right. Your line is now open.
Hi, good morning, Thanks for taking the questions just first I'm just given all the news Remy just you can provide an update if there's any sort of steps being taken to offset any impact of the corona virus.
You cannot the phase three trial for roll the power down and then second question for me just curious you could walk through the thinking in terms of choosing apathy as the next indication to pursue for Rolla power down just given you know what seems to be very.
Very broad potential.
For a number of psychiatric conditions, what this molecule. Thank you very much.
Thank you and so again.
Great question, so concerning the Corona viruses so.
To be to be very clear and briefly address this because the world set over events on Friday.
We are really.
Take this extremely seriously and we have really check to the situation with our CFO roles and and as of today. This morning. This morning, I have a check to gain was a clinically team and as of today be had all the patients in this study.
With all of these it's done so so as of today there is no impact at all.
Let me nimble broader way I think people have to understand that said we are in an extremely.
Favorable situation why because the first you know all the patients are recruits so in other words, we don't need there.
Response from whatever silicon labs from whatever.
Biological lab.
The tool in order to.
Order to get a results you not to take two to patients because everybody's into study and as you know we took really very carefully.
As the things in terms of getting to sample set aside and once number which is shipped in two different labs. So so really easy ongoing patients we have no no problem because like we always have a spectrum.
So this is a clearly under control and last but not least.
Keep in mind that them in the most of the study acquire Lisa complete studies and outpatient study and the patients are only coming to psychiatric hospitals strategically facilities are dealing with psychiatry.
To do their visits and.
Clearly the equity costs, which are not involved in that.
How many patients coming with symptoms of corn a virus. So when you put all this together I think we can be extremely confident and last but not at least.
We have already a lot of patients who have completed.
Double blind phase and.
Definitely let's see things a box on the number of patients we need so so I think.
We take it seriously we have to follow what is going on but it's really under control now concerning your second question.
Yes, I mean, you know because.
We have this opportunity to go into into different indications outside the schizophrenia, we had to made some to make some choices and we started to megs of choice to open the nine D in our policy and the and the dementia.
Those are very simple reason is that.
When you're looking to the symptoms when you're looking to.
What is going on into the in the brain of these patients. These are non cyber patient or may be a pockets and patient. So our another dementia you know.
Seems at the mean, we also took is a boxes here that will depend on can work. This eight.
And I mean at the end of the data confirms that they'd be true. This is not a big study we have to run this too to get.
It was a data we needed knobs and afterwards to two to move ahead, but obviously a zero other indications which are important like for example mood disorders.
As our other indications, which affords important like as Sig.
Oh, yes children are suffering from artistic these orders for example, and we are definitely discussing we some of this.
Associations, who are taking care of this autistic children, So where do you open to all the different possibilities, but I think.
This takes a little bit more times this needs a maybe a little bit more broader study. So we have decided to be pragmatic to start somewhere but this does not need that he will not jump into other indications. So.
It's a stepwise approach at the very pragmatic approach.
Okay, great. Thank you so much that's helpful.
Thank you. Our next question comes from Joel Beatty with Citi.
Your line is now open.
Hi, This is Sean Egan, calling in for Joel Thanks for the update today and for all for taking my questions.
On the phase three another trial is enrolled the general subjects 18 to 55 years old but are there any target age distribution that you're hoping to achieve in that study and then also on the phase three the 40% dropout assumptions can you comment on whether or not a blinded basis, even in line with that assumption and also on what percentage.
<unk> patients there are electing to transition to the open label extension. Unfortunately the study.
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Sure.
Great question. So so clearly I mean, a two to really restage the things extremely extremely well.
To get the.
You know to the stage of of the end year, yet to to get hopefully listings approved by the FDA. What's you have to do is to show that the overall study so from 18 to 55 years of age.
That that menu show a P value on on the mildly negative score onto incident on the punch as this is really much much what you need yes.
So clearly we will do some additional analysis.
As we have done.
I'll start with.
Nice to be in order to see if we confirms effect.
The age has the effect on the effect size not speaking here, but P values not speaking about the effect sizes and.
And this will obviously be done but this is not that all related to what we need in order to get the drug approved but we will definitely do it because.
More speaking with care was more speaking with ER with.
Conditions. It is throws at that meeting one of the sweet spots of.
Got it very Doug would be to really go after even dollar sensors risk you know were not developed as a complete the season, but maybe you can also see good but.
First episode patients, where you have really I think we that reflect repair than an extremely good chance to completely reversed course of the decisions. So so so yes, indeed see yes, I mean, we reconfirmed that see effect size in the younger population multi anchor participations.
Who are the phase three are showing any effect size remember it was above 1.5 in terms if effect size into younger Arkansas operation, We will definitely think about running a trial really concentrating on this the younger population so.
Normal practically have into your questions.
Definitely I mean, the we are in the study.
So phase three study below the 40 person dropout. So we are completely.
I'll, just say ticking takings, a box and I have to say that they forgot since the last point you asked me you asked me about the percentage can you. Please help me what was the last question.
Yeah, what percentage of patients have ought to do transition to the open label extension portion of the trough.
Okay. So we have never disclosed this but I can tell use that.
There is an important amount of patients who have been.
Transitioning to the extension and we have already a significant amount of patients who have completed the 12 month. So so it looks like that we will have a lot of patients going into the it does extensions and the lots who will complete the extension remembers that in the face to be study, where it's around 80% if my memory.
Not completely wrong, who went into the extension and you can see along these lines.
For the phase three.
Great, Thank you, right, which which which Richard Colombia small comment is is a great surrogates about how how well.
Patients are ends a hell of a while caregivers sink about what they see it was a direct so sites, where Jessica very nice surrogates.
Raging.
Great. Thank you.
Thank you.
Next question comes from Byron of men with Jefferies. Your line is now open.
Hi, Thanks for taking my questions. So Remy on the open label expansion what anecdotes can you provide on the patients that have completed and especially those patients that crossover from placebo to act that.
So so first of all I mean, I I don't know who crossed over from placebo to actually because of studies blinded. So so that you have no clue, who who was on the placebo is that but clearly obviously a button when people are going into the extension everybody is treated we certainly to our 64 milligram again.
No no two weeks.
They are sorted tour or 64 milligrams. So so its single blind, but let me. Nevertheless, it's blinded frozen homes are those so but clearly over the last nine months of means that patients are definitely a treated.
So.
I was you know I have visited the most of the sites.
All the sites or my colleague Mikey Davidson has also visited on lots on the side.
It's always a little bit dangerous to come to come up with these stories this but because it's blinded and and you never know, yes, but but I can tell you that I mean, there are some spectacular feedback site I get a site by these things are sites.
Well I mean, you have patients who had the.
Negative symptoms no drive basically evolution and negative symptoms.
And for years and they.
Trial and after few weeks of treatment they start to be really really interested in what is going on around XMC reengaged in a in real social life.
As a reengaged with families.
And some of them and even a job this and.
Steve.
In the jobs.
To be very clear I have.
No more and more.
Positive pressure from some.
So what next after one year treatment because of patients are going so what it. So so obviously we are phase three so we cannot provide the moore's exists.
But clearly I mean incredibly feedbacks.
Some patients who are really recovered this basically so say, it's obviously not general it's not.
Older patients a day I don't know, obviously, that's history with all the patients but.
Some of the feedbacks are really really very very positive and very encouraging.
And on the open label you mentioned, it's similar to the.
Phase three if he needs to be in that 80% went out to open label expansion, but so those that went on to open label extension how many.
Clearly if you're still in the process of completing the study but of the patients that.
Completed.
The open label expansion versus those straw that dropped out during the open label extension can you just comment on on the percentage of dropouts.
I can I cannot I cant, obviously, I guess the numbers, but I think as of today. It would be not fair to give you any percentage because I mean, we we have not if you enough patients who have completed the compared to the patients on going. So so you have to be a little bit patient to get to find the number yes, because this might evolve over time.
But as of today.
John but a lot of dropouts in the open label phase as as we had at least so you can compare to autism fuzzy.
Double blind faith, sorry, I didn't try my work. So so basically if not a lot of dropout Digi open label phase as of today, but again, so still a lot of patients in the open label phase. So so you would not be fair to give you a person such as of today, So stay with us a little bit and I will give you more granularity baby.
Next time, as we speak as pets, but it looks extremely good yes on the if you allow me to be a little bit more specific you know.
People are always traveling and not later than on.
Friday, when we had these care Wednesday, you gain a receipts a question.
So why.
Placebos react teens away. It is reacting and you study and why you to your notes have more people, we lapsing zones and what you had in the phase to be and they can tell you that into phase three because obviously this year have the data even even double blind completely blinded study in the you know how many patients are relapses.
It is really really a handful patients who are relapses. So I think what is what is becoming more and box here in the clinical and scientific communities that there is a significant population out there who.
Does not relapse Wednesday are not treated with antipsychotics and but since this is what we are demonstrating more and more.
Let us wage end of the study that does analyze the data. We we have varies I seek a large sample and I think this will overall beyond.
Repair them head descent. If you continue could community to sink differently. So there was a paper out recently, a very small study and happy to share. This was everybody showing that I mean.
When you are comparing patients who are at a Z recommended to therapeutic doses of antipsychotics and you compare them to population, where Youre Titrating Downs you antipsychotics.
Those areas no more relapse edens, titrated down population and and obviously the patients are functioning extremely well compared to two higher doses of antipsychotics. So I think there.
The space is really moving space is asking themselves are wide questions and I think this will be agenda for today for the benefit of what it very done has that people, who will prescriber repairs done, but but I think it goes beyond what apparel done it goes video.
The understanding of.
How to treat best patients suffering from schizophrenia.
Okay. Thank you thanks for taking my questions.
What most and welcome.
Thank you as a reminder to ask a question you wanted to press star one on your telephone.
Our next question comes from Massman say with William Blair. Your line is open.
Hi, guys. Just a question on the evolution of fun not tied it really interesting I'm wondering whether the baseline severity in incidents rights of evolution in the phase to be.
His bain match in the phase three trial that will get tighter absurd and also I'm curious as to if changes in evolution best captured by the model.
Negative factors symptom score or whether you really do need to use the sky or like the break from negative symptoms Skyone China.
Your kao else talk to on for asphalt.
[laughter] incredible questionnaire so so.
Yeah for the moment, obviously, we.
As Inovio, we additions, even though I said guidelines are heading used to do this I mean basically.
We're comparing.
As a pool of patients completely blinded from the phase to be study with a pool of patients we head into phase three study.
In terms of of the obvious upon some negatives Korea. So that's about this we are speaking here about the overall score as Amber and what is extremely clear from the data we have as of today. So comparing again blind blinded data from the two studies.
As a Z Z starting on the entry score on the negatives core he's a very similar between the two studies.
And there's a time course of as a first 12 month 12 weeks in or we are monitoring very carefully obviously is a so double blind phase at the time course of decrease of negative symptoms is exactly the same. So so this this is what we have and what you're monitoring.
On a regular base going to the to the granularity.
Oh population.
Today, I don't types of data.
Maybe my head of R&D has a data, but I don't have the information.
As of today, yes, but clearly I mean, do overall behavior opposite negative score coming out from from arms is definitely.
Going into is the same direction.
Interestingly enough obviously.
I wanted to know if there is no difference is a regional differences and and there are no regional differences, which is also extremely extremely good yes, including the USS.
Which is which is extremely good though.
I agree with use at a.
Tons is definitely not.
The best to tool because this is the reason why people what coming up with numerous times more Morse pacifically, how to say analyzing negative symptoms like to be NSS.
You know we did we did the analysis.
Because we had as a secondary endpoint appeared to be in assessing our phase to be study and has even been published and interestingly enough as a tool state scaled our really showing exactly the same effect of our drug Esa, which is which is a very very reassuring in a very good outcome. So so we have not.
To be a necessity is a into phase three but what I can tell you is that we confirm that you interface to meeting with the FDA, what you just can't to be used and.
The scale to be used as of today's teams that pumps.
And that's the reason why we as an arms. We have said decided as you know two to go visit mater negatives core out of the pounds.
For this very simple reason, which has been discussed also Friday. This care, while they are tailored breakfast, which is that GE 16 is is is the difference is a main difference between what we have used interface to be into phase three and this is really giving you a in addition of hint towards.
This is.
Obviously.
The way patients are starting to behave again with with.
Families and with with their environment. So so all in all I mean the.
Clearly it is a pumps you have to use and the second six are really going into right direction.
Cool that's helpful and then maybe changing track from roll a paradigm.
So that's an opportunity with had a chance to say the diversity go lumber excellent libel from a softer approval early this year just wondering your updated thoughts on the opportunity there any insomnia.
You know is it still about the Taiwan efficacy.
Lack of next I sleepiness value proposition, there or have you thought for that product change and then maybe a quick one for Jeff.
This 15 million left on the balance sheet for urea in process fresh in development I gather that's all related to Janssen and the this helps correction program. There when can we expect that to be realized cheers.
Thanks.
We'll take versus the first question enough with the hand over to Jeff So.
So thats, Nick definitely sensor Exxon by saying is there is a completely unique molecule.
For for Insomnia, Xie Xie ecosystem for.
For what is currently developed Oh, we see orexin pathway in mind AESA.
Really I think.
In some yeah as the specificity of sensor extend as you know we are the only molecule best of my knowledge in development clinical development already well advanced clinical development, which is a space FICO Rex into antagonist addressing this makes a complete difference.
In terms of.
Efficacy and in terms of safety compare to dual antagonistic so.
We have another attributes which is I think extremely important with other molecules that means a Z half life of the molecule is a short add back the PK PD.
Is really yet.
Spot on yes. So basically we are really sees a pharmacodynamic effects are basically helping people to stay U sleep.
For the times as a seven hours as a second half hours you need the in order to who have a good night of sleep and to be able to perform adequately during the day and I mean I figure. It was a very very instructive to study we de things a phase to be so first of all well powered I'm speaking here about Jesus.
Study.
What we call the in the past primary insomnia, so bad patients who have no other commodities.
And we really did did a very nice study I think.
Patients.
Also having.
A significant sample of elderly patients in the study and even in the elderly patients clearly is a drug is.
He is doing the job.
In terms of an efficacy and a zero impairment.
Compared to what you might see Weve got verdict molecule or what do you what you might see with.
With with dual antagonist Wrexham antagonist. So the so as of today, it's an extremely promisingly drugs in some indication.
But maybe Jeff I give over to your second question.
Thanks, Rami and thanks for the question miles you correctly.
Observe that $19 million, a noncash impairment charge was was incurred in quarter four not related to.
So they are in process R&D that we had on the balance sheet for Min 117.
And that relates to the.
The data that we saw in a November December time, following the the to be studying MDD patients with anxiety.
You rightly also observe that that leaves about $15 million on the balance sheet of in process R&D assets and actually that relates to men Threea won.
And obviously that went onto the balance sheet back in 2013.
When we acquired.
The company that own the three a one asset that doesn't get amortized until the assets is commercialized so that will sit on the balance sheet for a little while longer.
Great. Thanks for the clarification just goes.
Thank you.
Thank you.
Thank you. This concludes today's question and answer session I would now like to turn the call back over to Remy Luthringer for closing remarks.
Yes. Thank you so much so so already thank your for listening today and I know itself was a great questions because I think.
It's always a important to have this kind of questions because yes, indeed, I mean, it's through that.
I think people are not becoming more and more aware of that negative symptoms are really.
Something important did schizophrenia, but not the only much much beyond schizophrenia and.
So the question you have asked I think this is clarifying more and more things. So already. Thank you again for your participation and I'm looking forward to updating you on the on the progress in a very near future S. So thank you again and have a nice day bye.
Ladies and gentlemen. This concludes today's presentation. Thank you again for your participation you may now disconnect have a great day.
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