Q1 2021 Aptinyx Inc Earnings Call
Okay.
Good afternoon, and welcome to the App connects first quarter 2021 financial results conference call.
At this time all participants are in a listen only mode.
Following the formal remarks, we will open the call for your questions. Please.
Please be advised that the call is being recorded and the company's request.
At this time I would like to turn the call over to Nick Smith, Vice President corporate development and Investor Relations at App to Nicks Nick. Please proceed.
Thank you operator, good afternoon, everyone and thank you for joining us on today's conference call to discuss after the extra is the first quarter 2020, one and financial and operating results. Our press release, describing financial results and recent highlights is available on our website today on our call Norbert Riedel, Our Chief Executive Officer will review, our business and clinical progress.
Followed by Ashish Khanna, our Chief Financial Officer, and Chief Business Officer, who will review the financial results and addition, Andy Kidd, our President and Chief operating Officer, and Kathryn King Our senior Vice President of clinical development and Harold Merck, Our Vice President of medical and Pharmacovigilance are with us for the Q&A portion of the call.
Before we begin I'd like to remind everyone that statements made during this conference call will include forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially and.
Any forward looking statements are made only as of today and we disclaim any obligation to update these forward looking statements.
Please see the forward looking statements disclaimer and our financial results release issued this afternoon and the risk factors and the company's current and subsequent filings with the SEC.
Over to you.
Thank you Nick and good afternoon, everyone.
We appreciate you taking the time to join us on today's call.
Before we delve into our clinical programs.
I would like to share with you would definitely have recently announced the appointment of talk the joined MELA.
All of our board of you'd like it to us.
John <unk> six tenths of experiencing the academic and medical leadership training.
Clinical development and clinical research to our books.
And we are excited to have of join us as we progress into later stage clinical development.
Related to all of our clinical programs.
Although it has the only being a few weeks since our last business update call.
We have made important progress across each of all of four programs.
And what we call it.
We currently have three phase two clinical studies underway.
One and painful VPN.
One and problem Alger.
And one and cognitive impairment.
Our teams have been executing diligently on patient enrollment and these studies and.
I'm happy to report that each of these studies is tracking very well.
We also have been keenly focused on moving our PT of people going towards initiation of.
The phase <unk> study.
With the design intended to be registration and supportive in this indication.
And these past few weeks in particular have come with the number of positive developments for our P. C of O P program.
So all of it will start with those updates and Y X seven eight and sweep.
In late April.
And we presented additional data from our initial exploratory PTSD study at.
At the annual meeting of the society of biological Psychiatry.
S O P P.
These data provide insights on the stage one of the study.
Which parts of four week treatment period and included all patients and a double blind randomized parallel design and most consistent with and informative of our next study.
We reported the signet.
Picking the greater proportion of patients.
Chief the clinically life will change in the 50 milligram treatment group comp.
Petroplus people.
And the reliable changed the index is defined as an improvement of 13 points on more on the caps five total score.
And because they recognize the metric for determining wheel effect as opposed to affect the clip and purely by variability.
Oh, yes, the O P. P presentation of also highlighted that when accounting for baseline imbalances across groups and the patients the time since Thomas.
The percentage improvement on the caps five total score.
For the N Y activity, that's the 50 milligram group separated from placebo bias.
Statistically significant margin.
These additional analyses the region.
Of course, our confidence in the therapeutic potential of N Y X 783, and the treatment of PTSD.
Also in late April we met with the FDA for a type C meeting to discuss the future development paths and PTSD.
And two we view the key design parameters of.
All of our planned phase <unk> study.
It was a positive meeting.
And which the agency and provided us with valuable input on the variety of study parameters.
And we are on the process of finalizing the details of the protocol for the upcoming study of accordingly.
As we have laid out at a high level and all of public presentations to date.
This study will involve and evaluation of eight to 12 weeks of daily dosing of NY, except for the eighth suite.
And there to placebo.
Randomized.
Parallel design with the caps five total score as the primary endpoint.
We moved the proceeding with debt design and accordingly.
And the data are positive we believe the study has the potential for consideration by the agency as one of the true well controlled studies.
Quiet and support of and N D a.
Of course debt will be a matter for review by the agency followed the completion of the study and to leave you off the data.
We plan to provide greater details on the study design.
And contingent you anticipate because we will commence the phase II study.
And the second half of this year.
Let's please can you discuss and why extra and 92, five which is in phase two clinical development of course, two chronic pain indications.
And painful diabetic peripheral neuropathy and.
And in top of my Alger.
I am glad to report that we have made excellent progress in both studies.
And we continue to be on track to watch all of the enrollment goals and.
The projected data readout in the first half of 2022.
We appreciate the continued engagement from the investigator sites and patients involved in these studies.
Let's move now to NOI of four of five eight or a product candidate and developing for the treatment of cognitive impairment.
We recently announced that we have we come in and exploratory phase II study.
In patients with cognitive impairment associated with Parkinson's disease.
And with dementia with Lewy bodies.
This is the first time and why it's four of five to eight is being evaluated and patients with these diseases.
The fixed float, which always studies designed to detect the signal of therapeutically relevant activity of and why it's four of five eight.
And to assess its tolerability profile and this patient population.
This is a double blind randomized parallel design study.
And is expected to enroll approximately 100 patients.
Shall we see if daily dosing of either 30 minute comes off of and by a full five eight.
The placebo.
Over a 12 week treatment period.
Given the the novel mechanism of N y X four of five eight.
We are evaluating multiple copies of endpoints and the study in order to characterize the activity of course the attention.
And movie and executive function.
I am pleased with all the pockets so far.
And we expect to be able to truly pulled the data from the study in the second half of 2020 two.
With that I have.
And I'll turn the call over to Ashish to review, our first quarter financial results.
Thanks Norbert.
As we make progress across each of our programs. We are fortunate to be supported by a strong cash position.
We anticipate our current cash will fund our operations into the year of 2023 and.
Labeling of Readouts from multiple phase III clinical studies, along the way in 2022.
Specifically, the beginning with the balance sheet.
We ended the first quarter with $146 $8 million and cash and cash equivalents compared to $141 million at the end of 2020.
Revenues for the first quarter were $1 million compared to zero point $8 million from the same period and 2020.
These revenues were related to our research collaboration agreement with Allergan.
All of a subsidiary of I V.
The collaboration agreement has come to its predetermined contractual conclusion.
And accordingly, we expect no for the future revenues associated with it.
The majority of our spend was focused on research and development related to our ongoing clinical studies across chronic pain and cognitive impairment.
R&D expenses were $10 $3 million for the first quarter compared to $11 $5 million and the same period and 2020.
We expect R&D expenses to increase throughout 2021 on account of our three ongoing clinical studies as.
As well as our planned phase <unk> study of NY at 783 and PTSD.
The reported G&A expenses of $5 million from the first quarter compared to $4 $9 million for the <unk>.
Same period and 2020.
Finally on net loss for the first quarter was $14 $2 million.
Compared to a net loss of $14 $7 million for the same period and 2020.
I'll now turn the call back over the Norbert.
Thank you Ashish.
This is an exciting period of time play out to next.
With all the three ongoing studies progressing very well.
And with another PTSD study to be initiated in the coming months.
Yeah, and next will be critically important for us.
As we seek to play better therapeutic options to patients and neat.
We feel confident that our focus on the execution across our clinical programs.
Along with all of our strong financial position.
And enable us to achieve multiple potentially catalytic milestones.
Within the next 12 to 18 months.
We will be happy to begin taking your questions now and.
As we feel of the questions I'd like you to keep in mind.
We will be a limitation on how much we can talk about our next PTSD study.
We are still awaiting the minutes of the meeting.
With that I'll open it up for Q&A now.
Thank you Sir as a reminder to ask the question you will need to press star one on your telephone keypad.
Please limit your question to just one question.
So without we could.
Okay.
So thats all participants and ask the questions. Please standby on well compiled the cause of any roster.
Yes.
[laughter].
Our first question comes from the line of mouth Minter from William Blair. Your line is open.
Oh, hey, thanks for taking the questions and congrats on the the STI and maybe my first one is just on the assets they paid data.
And the correlation that you saw the train enhanced efficacy with the 60 milligram Darcy and patients that had a multi res and traumatic events selling of the Patriots day.
I guess, given you have those learnings now and how you're thinking about incorporating the hours into the trial design would that be something and the inclusion exclusion criteria for that trial or would it be something more like a pre specified analysis way you might want to stratify the patients by you.
Half of the dataset.
Thank you Mike.
Question I'm going to the house and you kick it off with giving you a sense of way of how we are thinking about cash at this point, yes. Thanks, Myles and good question like like Albert said, we kind of sort of be definitive about that I think one thing we would say on the specific question, though.
It is our preference would probably be to avoid entirely excluding patients where the longer time since trauma.
And we'd probably be looking to other ways to incorporate that learning, but we can be more specific once we finalize the study design and I think that's the only point, we want to make right now.
Okay Fair enough and then are the.
And talking to a few clinicians I think at the the clinically meaningful improvement on the title of caps five.
The 10 points from baseline with the treatment and you definitely saw that.
In the space the day trial, but they also made a comment on four point type of let's say by I guess does that kind of jive with what.
You would anticipate being clinically meaningful life of placebo and and I guess the obvious question would be.
And you expect to obtain that going from full lakes of therapy to eight to 12 weeks like the sneaker lighting.
Yes, I think Thats I think thats the.
Roughly right Myles.
Think of we would expect to see.
Perhaps the continued improvement over the course of four weeks to eight weeks as.
And as well as the few other factors I think again, which we can get into more of and the detailed study design.
Help of diet as well as obviously the study being.
Being larger.
Yes, I think that's the I think that's fair.
Okay, but just to be definitive beauty you'd agree that a full point, maybe five of placebo would be the clinically meaningful threshold here.
I think it's in the right direction, but I don't think we'd be pinned down to that exact number again as we designed the study we will think about specific effect size that we're looking to see and that we're powered to show and so forth and again, we probably can be more specific on the line.
I kind of Coke and my final question is congratulations on on John Miller on the board that's of Great appointment. He obviously has the extent deep expertise and ophthalmology.
So the question, but it does.
The question, whether you're going to potentially look at expanding the NMDA and much of light of platform into the ocular indications.
That's something you're thinking about or am I can slightly on the wrong.
Out of the ballpark on this one.
So I think my thought.
Really all of our excitement about joy of drone and joining the board of cleanly.
Extensive academic and medical leadership experience and you instead.
That'd be pointed out in the press release.
As well as true involvement and clinical development and clinical research all the way to basically having been instrumental in getting the first therapy approved for a M D and so that's it.
Terrific.
I think as we have communicated before they pay on numerous other areas in which NMDA receptor biology of developing.
And shown to be involved in various diseases beyond what we currently have on our plate.
But for now we will stay the course with the indications we are in and.
Yeah.
See where we go from there.
And when the time comes to basically extend all the scope.
And I look forward to join and being a key contributor to actually help of tests and what makes the most sense and how to go about it.
Once again as a reminder, please limit your questions to one or.
To allow other participants to ask the question. Our next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.
Yeah. Thank you on Norbert and team congrats on the.
Progress in the quarter I did have a question on line and follow up on.
And on the PTSD program 783.
Yes, I'm wondering you mentioned, having a positive type C. Meeting can you provide any color I know that you are waiting for the meeting minutes, but any any key takeaways that you consider positive was the positive with regard to the agency's awareness of the challenge.
And of PTSD.
And the mechanism of 783 that could be differentiated or some design feature debt that you want to point to and then I did want to ask you recently, the MDM and the E.
Travelers then write down I'm wondering if there are any new kind of thoughts that you have on PTSD and the opportunity there given.
Given the MDMA results. Thanks.
Terrific. Thank you.
So look the type C meeting was very positive in debt I think days of clear.
And all of it's been a heck of a condition.
Debt PTSD is a significant challenge we have and for.
All of which they are very limited CFO and choices.
And I think debt.
And so call it of new mechanisms and new approaches to finding ways to actually serve south of us from PTSD much better.
Thank you both of which are positive and Thats, what we have communicated before as the <unk>.
Outline of all of that study.
And is indeed, the roughly how we would go about it and as we pointed out there will be details of the nuances to that debt, we've communicated because of lifetime, but I am pleased that whats the outlined and communicated before it's very much in line with what the phase III studies went and looked like.
On the M DMA at least.
And I think that's actually very very encouraging for a number of reasons first and most importantly.
It looks as if it's truly makes a very meaningful difference to patients who have actually been treated with M. D M and H compared to placebo and PBT.
And for the I like about it is set.
Our definition of what the mechanism that need to be active in the treatment of PTSD.
It's Tony is about plastics, if you change it.
It's basically I would say includes terms and we set.
Of the cockpit of network.
And I believe that.
Mechanism of an M D and the NMDA receptors and plasticity enhancement works along those lines.
We have shown and I very much liked that mechanism and the superb safety profile and Tolerability profile that comes along with debt debt, we haven't always devilish with three of our compounds.
And could you lots of numbers of ease of healthy volunteers and patients. So I think that differentiates us and.
That's why we are really excited about where we go about it and how we go about PTSD and other indications.
I was hoping you'd make of that mechanistic connect.
Connection and I appreciate you, taking my multipart, but single question.
Thanks norm.
If you have another one on electric sneak it in no Chas.
I can't.
And finally, I want to be respectful of the other people on the on the call.
And maybe when do you have kind of at the end of June you'll get back in the queue.
Yes.
Thank you.
Yeah.
Our next question comes from the line of Joon Lee from through the Securities. Your line is open.
Hello, My gasoline and for June.
And for taking our questions.
Regarding the phase two b trial from 703, and PTSD, what proportion of civilian and military PTSD patients who've been Robin if you could give us some color on debt and how do you think as it relates to moderate.
And if you could just yet but as one and.
Do you expect the accumulated to two nine to five what are you sort of bigger and effect on advance the pn patients that would be a larger benefit of 70.
And also in patients suffering from severe and PTSD or having PTSD for longer periods.
Okay.
Okay, let's see how we can take over because of the team.
I'm going to.
To get to your part of the Chris Smith relates to the D P and study and at.
Patients with more established the longer duration of disease.
Just make the comment of charge that we are looking at it from our point of view of plasticity changes.
And and D P and of course, the disease, the neuropathy stopped and the published about the but over time, it manifests itself centrally and stuff cause changes in how pain is actually perceived and processed.
So mechanistically it makes perfect sense debt advanced patients those who have suffered from the disease for a long time.
Have a more pronounced.
Manifestation of the pain perception and processing issues in the operating which is why we actually rely on the earlier study we have gone by saying Mechanistically It makes sense to.
And to have the carbon phase <unk> study focused on patients that have.
I had a longer duration of disease.
I think that answers your tpa and Christian.
We have and you get the tie to the PTSD study.
Already yes.
Good day to patient numbers of the types of trials and.
And I'm sorry.
We will not and cannot comment on debt and <unk>.
We actually first of all in possession of the minutes of the meeting and have truckload designed and finally, a lifestyle of <unk>.
Okay, Yes.
Yes, Thanks, Robert I think the one thing we can reiterate because we you know we did make the point that the study design and we had outlined to you and prior calls and so forth.
Still the direction that we're heading.
We still as we said before our plan to enroll a fairly broad PTSD population and our general philosophy would be to try to include as representative of <unk>.
Patient population.
Possible of the entire PTSD.
Patient group.
Beyond that I think that's fine we can comment more obviously, there will be some specific inclusion and exclusion criteria and we will apply and I think we can comment more on those once we finalize the study design.
Thank you and very quickly semi in the forefront.
And that's why we showed the durable benefit on the.
And <unk> model of Parkinson's how do you think this would translate to of disease setting where do you expect less NMDA receptor expression.
Okay.
And if I guess on the central crest of that Youre, asking and mechanistic question as to how full five eight goes to about an hour actually view of the data about pick up true potential therapeutic benefits in the.
Copies of impairment and I'm going to have all of it actually address the question.
How about if you wouldn't mind and following up please.
Yeah of course, and one of the observations, which led us.
And almost two basic and you combine the indications of <unk>.
The main insurance dementia with lewy bodies at the house.
And similar to the.
All of the G, which is based on an increase on Iqos and locally because we view the basis of both all of those and it is known from preclinical studies.
Moving to a.
Downregulation of an NDA acceptance tests and demonstrations.
And the number of and if my model is.
Our own data on the effects of.
And thanks a lot.
That is the compound which outbreak on dates and then the receptor.
<unk>.
The very mechanistic of way.
The working hypothesis and say that we are.
And basically with one of the things with the on liquidation.
And I put some cream and expect to see beneficial clinical effect spices and east.
And if you want so.
All of the pathology.
The welcome hypothesis based on Analyst day, you talked about I think.
And as strong as it gets and this.
Alright.
Our next question comes from the line of Laura Chico from Wedbush. Your line is open.
Good afternoon, and thanks for taking the question I will try to focus it to just one and I definitely like the ask Glen on 295, and the Fibromyalgia study. So there was recently published study on fibromyalgia that examine whether sensitivity trans and the relationship to interest scores. So it was interesting.
And that nearly two thirds of the subjects were deemed to be sensitive to weather and ended up having worse and our scores.
And just looking at the geographies of the Phase III studies for two nights you side, you've got a pretty diverse sampling here across different U S regions and just wondering if you could talk a maybe your thoughts on how you might be controlling for that variable on the study, but also be just.
Remind us about any powering assumptions on the primary endpoint thanks very much.
Great. Thanks, a lot.
Catherine would you like to take the question and share your thoughts.
Yes, I think as you noticed you've got a diverse and kind of wide geographic.
Spread of our site so I think.
With respect to that impact, we certainly could look for it but we'd also expect debt with enrollment across that wide variety of sites.
And that it didn't dramatically impact on results. We should still have results that are interpreted Paul and a general sense I guess I'm sort of just to say if this is something experienced by the fibromyalgia patients we'd wanted to account for it and any therapy that we bring to market as well so it'll be interesting to explore it as we go.
And there's also.
And sorry I believe this has also been noted and.
And diabetic neuropathy and other kinds of chronic pain and it's not I think that on common are unique the fibromyalgia.
And and.
Agree with Kathryn.
We have the appropriate I think of geographic spread and.
Powering of the study to tick up of it.
Yes.
Our next question comes from the line of Marc Goodman from SBB Leerink. Your line is open.
And the Norbert and I was hoping you could give us some color on the enrollment for 295 and the studies.
Any type of.
Color would be helpful drop out so far or anything I mean.
Where are we and the process. Thanks.
Great Mark Thank you.
From previous communications paths that we go and actually of any specific details on the and all of them and Gulf All the studies.
I can share with your debt Outspeak design and studies and basically that's the model we can with respect to size sort of the timeline, we take into account and numerous paradigm of tests, including 12 out of beta and the like and as I make my comments in the prepared remarks and we are.
Lots of commodity light on track and we sit at home and and Kantar.
Confirming that the when you talk of all the data in the.
The first half of 2022, and so you can deduct on bad debt.
We are satisfied and pleased with the trial and how the time it actually conforming to.
What we had set out to be the likely part of that and because of the study.
That's typically where the limit it to.
Discussing all of the studies at the ongoing studies so far so good.
And then just just a clarification on one of the thing the Parkinson's and the Lewy body patients that you're enrolling I think you said it was 100 and total.
Will this be pre specified for both groups and are you trying to do half and half of our you're just taking on.
All comers and either how is this working.
Yes, Mark So we are.
The pre specifying our strategy buying and in particular way.
And so.
And it's likely based on what we know about patient numbers and the back of the extent of wet.
Those patients are diagnosed and likely to seek entry on the clinical trial and error.
And probably be.
A mixture of all of the three of the Parkinson's Mci Parkinsons disease, dementia, and dementia with Lewy bodies.
And so yes, we expect a mixture of but we haven't got any stratification.
Thanks.
Our next question comes from the line of Ritu <unk> from Cowen Your line is open.
Good afternoon, guys. Thanks for taking the question.
On spot.
And I understand that you haven't nail down.
The final design of the phase III Pizza the study, but as you think about phase three study one of <unk>.
The three studied number two are you.
Huge is the FDA sort of generally and alignment that the two studies can essentially be identical.
And do you think you might have sort of orthogonal populations that you might want to investigate separately.
Could you address that and the next kind of fat and quick follow ups.
Yes, Richard can address that for sure and I should clarify it's the phase <unk> study.
And so we have not had and end of phase II meeting. This is the type C meeting.
I think when we say that.
Believes that.
This study if positive could be used to support registration and could potentially be a pivotal study.
Norbert said in his remarks that very much and matter of future FDA review.
We certainly want to design the study to a life of that possibility, but it would be a matter for the FDA and on what the day to say if thats. The case, then we would.
We expect complete one further pivotal study, but I think that's also.
What that would exactly looks like.
Part of what we would wait until we have.
FTA minutes and until we finalize the study design to comment on any more.
Got it and then.
Just on your four of five eight.
Cognitive study.
You mentioned you are looking at multiple conferences on points of comes from memory on the flex it.
From.
How do you prioritize those three.
Some of them some of your competitors with different mechanisms and also looking at Parkinson's cognition seem to be focusing more on and frankly dysfunction.
And I guess I'm wondering if that's based off of that.
And so communication or cable opinions.
Yeah.
So first of all of the ASP you pointed out, let's say exploratory sick, they're finding studies. So we basically want to give us the opportunity to look of course multiple neurocognitive repo in no particular by you all the types of or the.
We know from four of five to eight of the preclinical studies, we have done debt. It is very much of common college active of course, the domains and we are talking about.
Executive function and cognition learning.
And Thats, what we actually want to confirm so that we can then you would see that information flow.
The next study just like we have done and the other indication to.
To be much more targeted as to what specific and even put them and be looking for it. So yeah. We keep all of the steps needed the opportunity to be border with the always prioritizing any particular endpoint Christie.
Anything you want to add.
Maybe just the.
And the competitor and that you're referring to.
Has has made a comment I think that they were.
<unk> to see more of an improvement on executive function and not perhaps so much on attention.
We don't sort of exactly know what data may inform may have informed on expectation I think if you recall, our preclinical data that we achieved and model and non human primates. The MPTP model.
Generated really robust findings across <unk>.
Irrelevant cognitive domains and so we have no prior such expectation and Thats why we are studying.
Studying all of these different cognitive domains utilizing the different endpoints and cognitive tasks and.
And the different areas and we'll see what the datasets.
Great. Thanks for taking my questions.
Our next question.
Yeah.
Our next question comes from the line of Gary Nachman from BMO capital markets. Your line is open.
Thanks, Good afternoon.
Just following up on forefront of day, just remind us why you're just using the 30 milligram dose do you think theres the chance that you would need to change the.
And the dose at some point down the road depending on the outcome of the study and then while Youre focused initially on Parkinson's and Lewy body dementia.
The other cognitive dysfunction indications that it could potentially inform you on once you have that data in hand.
Great. Thank you Gary So I'll take the first part of your question.
Gary I think I've mentioned before that we do a very extensive preclinical work and looking at dose range as to where we see the most effective dose of all components and.
And we then confirm.
And the presence of compound in healthy volunteers and phase one to make sure we can correlate crate and exposure to the preclinical models. We have now done studies and travel and biology, and PPA and then and PTSD.
And I can say with truly a level of satisfaction debt, we have been pretty much right on target picking the right goal.
Predicting the dose that would be the most effective in the <unk>.
Range as we have looked at so here, we have a pretty high level of confidence that the 30 milligram dose is the right choice to drill this exploratory studies, but we saw the Dow.
We will in future studies do dose ranging as well.
We would do for all of the benefit and also because of it because they like the requirement that the agency would have.
But there is no reason to burden the first explore with the always picked up finding study with dose ranging on top of just particularly texture and wanted to see.
And then there was the second part of your question.
Yes.
Yeah and the calendar.
And I'm too yes.
The data that you'll have on the Parkinson's and lewy bodies dementia patients.
How does that can inform you for other potential cognitive dysfunction indications.
Yes, I think generally we.
And I think Harold ran through the mechanistic rationale.
Earlier that and Parkinson's disease part of the neuro degenerative process results and reduced NMDA function, but that's not unique to Parkinson's disease.
You know quite of few different causes of cognitive impairment involved and paired NMDA function and so I think once we have clinical proof of concept and this area. We've always thought that we had broad applicability and multiple different causes of cognitive impairment and I think.
And that remains our debt remains our plan.
Okay. Thank you.
Thank you.
Our next question comes from the line of Chris Raymond from Piper Sandler Your line is open.
Hi, This is ally <unk> on for Chris today, Thanks for taking the question.
And so on the 73 data and <unk>. It was really helpful. The see the additional analyses adjusting for baseline of balances and in time since trauma for stage one of the trial. Just wondering if you from that analysis on patients and stage two of the trial and if we can expect to see that or any other additional.
She's presented at some point and then just related to that and hoping you could characterize the kind of feedback from the PTSD.
And communities since presenting the data at Ash OBP, just any color on what most stood out to docs on the day that sell for the mechanism of <unk> 73, or other aspects of the program that would be helpful. Too. Thanks. Thank you.
Great question, So I'm going to have parallel of activity provides you with the.
And towards the close he activity.
If the one of the work presented the data and more stay at P. S. O V. P of meetings. So I thought if you protect all of that one.
Yes of course, I mean, just to say.
The.
If you want sort of adjustments all of you on that as well.
Really motivated by the data as they say on the Q1 and then from randomness of course from the baseline perspective, you don't know, particularly on the smaller study what's the specific characteristics are and if you.
Presented on our post the most significant imbalance regarding baseline severity on the caps five and also at the times and strong muscle and this basically motivated us to deal with the addition of on that and the switches I think scientifically is the right thing to do we want to make sure the compare this with assets and no.
With anything and.
And regarding the stage two.
And somewhat.
Unfortunate situation that are much smaller and then would you.
And the anticipated ended up and states.
Which basically makes the stage two much underpowered and order to come up with any conclusive.
Resides.
So it didn't look like and balances in stage two because the.
And the comparator.
And that and 12 subjects were actively treated.
The 16 subject and the placebo group.
And just not meaningful EBITDA would have.
And the outcome of some amount of business.
Regarding additionally, the amount is.
We wouldnt exclude the idea of doing any additional post talk analysis based on new evidence sometimes of nice publication comes out of you want to verify you can see the same thing.
And would say that this morning and time the vehicles you're on that as this has been done.
And I would say to our satisfaction the understands the data on structure quite well and.
Paul.
<unk>.
Justification of the based on the data.
Yes.
On your second part maybe I'll kick it off of Mechanistically, what we target with seven to eight tweet discretely hypofunction and the prefrontal cortex of NMDA receptor activity.
And what is well known to be <unk>.
Additionally, two of debt.
And it really describes PTSD and why people a couple of on P. T. A C because they can.
Hopefully the extinguish the fear and consolidate the <unk>.
And we have shown pre clinically that seven and eight if indeed active in the area of extinction extended weighted in Chile as well as consolidation.
We believe that this is the more mechanistic rationale of debt at twice the underpinnings of PTSD compared to the only two other approved therapies in PTSD today, which helped.
And.
Of course helpful and you have since adjusted question of any examples, but they don't really get two of the underlying the root cause of what makes a distinction between people suffering from PTSD and people, who extinguish of tomah without becoming PTSD and stuff on it.
And.
It's important to keep the pointing out.
How about I don't know if you have feedback from Kols that we want to actually operate and share.
Yes.
So most of that much the biggest we know the supposed to virtual come from before.
Somewhat difficult to get into contact with FIFA.
We took our sales quite of bit of big by getting in touch with but nothing specific with guidance on what date.
Okay.
So the answer to your question Ella.
Our next question comes from the line of Silver and Silver Rod you.
<unk> <unk> from H C. Wainwright your line is open.
Hi team. This is myles on silver and silver Rajeev. Thanks for taking my question. So I was thinking about and why X 708, three and came across a negative allosteric modulator owned by Novartis. They have licensed it from Cade and <unk> Therapeutics, Inc.
And J H, two one and.
That's showing safety and efficacy in treatment resistant depression, I'm wondering if you're tracking this and I missed this could pave the precedent for a TR the integrate and indication full and my ex 700 <unk>. Thanks for taking my question.
Yes.
We're certainly aware of that program and and.
And we followed a decade and debt.
And the partnered with Novartis on that and were acquired so yeah, we definitely follow it.
It might be worth on the only just a refresher on the history of our program and we are treatment resistant depression has has has played into that.
Yeah, Hi, this is on.
Sheesh.
You will recall that.
And the next of course was spun out of our predecessor company and <unk> as we sold and Rx the Allergan and back in 2015.
The impetus for that sale was allergens interest and.
And the data we had generated on earlier chemistry.
Peptide chemistry, IV administered and therapeutics.
And for the treatment of depression major depressive disorder, and CRD, we had multiple large well controlled phase III studies across two different peptides IV administered and peptides demonstrating.
The compelling effects and and depression.
And as part of that deal of Allergan.
And we are engaged and a research collaboration.
Round or after the spin out of.
That does put some field restrictions on after the next and included in the field restrictions is the area of depression, and so we will not be going into may.
The major depressive disorder, and the near term.
Okay. Thanks for connecting the dots the I'll get back on the Q.
Our next question comes from the line of Jessica <unk> from JP Morgan Your line is open.
Hi, the he Danielle from Jessica Thanks for taking our question one quick question here.
And we haven't heard about the impact of COVID-19 on enrollment and other ongoing phase two of the DPM studies I know you mentioned in prepared remarks and from our lesson. The Q&A and you can remain on track for the studies to read out in the first half 2017, so curious how much of an impact.
And she has made helped with enrollment.
Yeah, Great question and thanks Danielle.
And when it hit the true you to just give a quick update.
Yes, I think we continue to monitor the impact of COVID-19 on our trials.
And we're happy with the way things are progressing and manage the issues as they come up but we remain on track and so we've described.
Thank you.
Yeah.
Our next question comes from the line of Charles Duncan.
From Cantor Fitzgerald Your line is open.
John I would tell you there.
Yes, yeah, Yeah I was on mute.
Talking to myself, sorry about that thanks for taking the follow up.
It did have a question on floor Science day actually I'll ask two questions. So theyre not multipart one is on <unk>.
Planned the PD and D. L. B study that youre pursuing.
For the PD patients are these pre dopamine therapy patients or are they on stable background and I.
I guess I'm wondering how you think PD kind of admission shows up relative to save moving movement disorder within that.
Great.
And that's you took the opportunity of Charles can follow up of course, we have the time to do so.
The hint that true.
Yes. So indeed these are patients who have to be on the state of the many case and they can be treated as of today with over there has to be stable.
These.
Patients can have movement disorder, but do you have some exclusion.
To that we got the people who hubs and just all just mutual and then you must of course.
This assessment is just on the most of our uptake would not be announced and participate so the general focus was on cognition, but of course you have to mix.
Net.
There is no interference if you want and so between the most of the dysfunction and just the capability to participate and those tests. So many patients would be stable, but it's reported.
Yeah.
Okay net.
Helpful. And then just kind of the perspective builder follow up to a previous question.
And how big of four or five day could be or the mechanism how broadly applicable that may be and I guess beyond just highly prevalent disorders. It seems like there are some neuro developmental disorders and are driven by athletes and nuclear.
And.
Yet those disorders, and really hard to treat and.
Patients may benefit for a long time, such as <unk> or GBA.
Shane Parkinson's and I'm wondering if you have any sense of.
Maybe going to a more rare disorder paradigm. Once you see of signal if it's positive with four of $5 eight and PD.
Yeah.
Great. Thank you Charles Kinks that after we typically go about it.
This is typically says we have a reliable picking up on set of skills.
And then I think we are very open minded to asking what else should be targets I like the idea of rare diseases of call. It.
And so that goes back to the question of how broad Kansas mechanism B and.
We would certainly look at.
Diseases, where a correlation is likely between the NMDA receptor function and quality of different patterns.
Across the board of those debt you also mentioned a moment ago.
Okay, maybe there isn't the same.
Yeah go ahead.
So sorry about that so adjusted to say.
Indeed, the very broad mechanism.
And definitely got the inflammation and gender.
Also to move down the road.
And the sectors, you can think of like diabetes downregulation of NMDA receptor and so I think mechanistically net.
Would be the place to look at.
And because we believe.
And we'll be able to and we've got so but indeed is the power the generalizable mechanism with much modifications.
So as far as the signal.
And next year. Thanks.
Thank you.
We have a follow up question coming from the line of Gram Silver and <unk> from H C. Wainwright. Your line is open.
This is the muscle on again, just a quick follow up regarding and Y X four of five eight I was wondering if youre aiming to coincide the data readout.
Later this year with the specific conference in mind.
The data of these are just actually debt the second half of next year.
To be clear and.
Yes, I would say very much like the justice <unk>, we will look for the appropriate medical or scientific symposium.
And that is suitable for the data presentation and discussion.
We are still quite a distance away from the day the rebuilt so the T, where we come out and what sort.
And sort of like the logic of set of confluence of official consider.
Alright, thanks very much.
Yep, you're working on this.
I am showing no further questions at this time I would like to turn the call over back to Norbert for any closing and.
The closing comments.
Yeah. Thank you operator, and thank you all for your questions.
We appreciate your time and your attention please stay safe be well and enjoy the rest of your day.
Okay.
Thank you again for joining US you may now disconnect.
And.
Okay.
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