Q2 2020 Aptinyx Inc Earnings Call
Ladies and gentlemen, this was a conference operator today's conference is scheduled to begin momentarily at that time once a week M placement of musical they keep repeating.
[music].
At this time, all participants are no listen only mode.
Always a formal remarks, well open up the call for your question.
That buys for the call Mr. recorded at the company's request at this time I would note with Atlantic over to make Smith senior director of corporate development and Investor Relations at after Nick Nick. Please proceed.
Thank you operator, good afternoon, everyone. Thanks for joining us on todays conference call to discuss after Nexus second quarter 2020 financial and operating results.
Yes are we just describing financial results and recent highlights is now available on our website.
Before we get started I'd like to extend a warm welcome to join leap from Truest security to recently initiated coverage on the company. We're excited to have enjoyed a strong.
On today's call Norbert read all our president and Chief Executive Officer will discuss our business in clinical progress or by she's Connolly, our chief Financial Officer, and Chief business Officer.
I will review the financial results. Additionally, for the Q and a portion of the call. We're joined by Andy Kid, Our Chief operating Officer, Trapper, King Senior Vice President of clinical development, and Rwanda Gritty Harris Senior Vice President of medical and Pharmacovigilance.
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 uncertainties that can cause actual results to differ materially.
Any forward looking statements are made only as of today when we disclaim any obligation to update. These forward looking statements. Please see the forward looking statements disclaimer in our financial results release issued this afternoon and the risk factors and the company's parent and subsequent filings with the FCC.
Now my pleasure to turn the call over to Norbert.
Thank you Nick and good afternoon, everyone.
We appreciate you joining us on today's call and hope that you.
Your colleagues and your loved ones all in good health.
The past few months, helping marked by our teams dedicated efforts to advance our pipeline of clinical programs.
Highlighted by our Chief Middleby significant milestone in the completion of enrollment in our phase two which go where choice study.
And why except the mates BNP PSB.
Additionally.
We're very pleased to share with you that being the final stages, hopefully commencing our phase to be studies soap and why ex Tonight to fight.
In chronic pain.
These studies were published in March Funneling de escalation off the cobot 19 pandemic.
We expect almost all the open why X two nine to five feet troubled my Alger to commence in September.
Followed by the painful DPN study late this year or very early next year.
Almost is called which is especially noteworthy against the backdrop off the ongoing pandemic anti empowered the dedication.
Demonstrated by watching.
Let's just call it somewhat the specifics of all pipeline programs.
I'll begin with an update on all trades to weigh exploratory study off in like seven eight suite.
In June we announced the completion of enrollment in this initial phase two study.
We call. This is a study.
Should be an old 160 patients to evaluate the safety and efficacy.
And why it's 73 in patients with PTSD.
This is the first time and why it's seven eight suite is under evaluation in patients with PTSD.
And our primary goal is to obtain data and insights generated from this study to guide subsequent study design and future development.
As it leads to mind off the study design, we are evaluating two dose levels will fit in white seven eight sweet.
10 milligrams and 50 milligrams.
Compared to placebo over four weeks off once daily treatment.
We are employing a sequential probably a compelling design.
To enhance signal detection in their population known to exhibit high placebo which points.
In the study we are utilizing the kept hyperscale told it's cool.
And last got Sops course to.
To evaluate the African fuel and why it's seven eight suite.
Importantly.
We're also evaluating multiple other symptoms.
Including MUFJ sleep.
And cognitive function will be other your secondary and exploratory endpoints.
The usual for caps fights.
Would you build your it's all the symptoms of PTSD. According to the DSMB fives in.
In combination with the other endpoints.
Enable us to understand the efficacy poll follow up in the bike seven eight screens.
<unk> different manifestations off the disorder.
Asked me evaluate the unique mechanism up in bike seveneight sweep in patients for the first time.
We expect to learn more about the most appropriate dose level.
And please.
Effect size expectations, and patient inclusion and exclusion criteria to employee in the design.
Oh wildly and conduct of larger.
More definitive studies.
The last subject test piece would be completed honest assessment in the study.
And we have shifted our focus to study closeout activities.
So to get the data collected entered ready for analysis.
That's doing some uncertainty along with any impact the corporate 19 pandemic may help on the efficiency of our clothes are there particular cheese, but based on all experienced thus far.
We anticipate reporting resides in the fourth quarter of 2020.
As a final comment on then bikes 73 I.
I would like to highlight the virtual PTSD focused R&D event.
And our team hosted on August.
This program featuring presentations from our management team.
Our comprehensive preclinical data and the mechanism of action up in why extrapolate suite.
As well as a presentation plummet, leading medical authority on PTSD.
Talk to them at least team.
Dr. Stephen is a distinguished professor of psychiatry at the University of California, San Diego.
And provided a comprehensive overview of PTSD.
The company's treatments.
And the substantial unmet medical need.
I would encourage anyone interested in learning more about all P.T.S.P. program.
Two views this presentation in the events and presentations section.
All that site.
Let's now move trend wise to nine to five.
What you mean clinical development into chronic pain indications.
Probably my old job.
And painful diabetic because that's when all the C or D P. Ed.
Well, maybe suspension of our two phase two studies due to the coldest 19 pandemic.
We have been working diligently honestly commencing and executing be studies.
The focus on patient safety and data and technology.
Those extensive efforts.
Let us see experience, we gain to new holding PTSD patients doing to pandemic.
I have served us well.
We recently received I'll be a pool and have begun to we activate our phase Twob study off and why it's to not to fighting problem Allergan.
And we expect to resume the study in September.
We have also been working hard to incremental appears to be studies and painful TPN.
A patient population, it's hard to at least two corporate 19.
We now anticipate that this study will lead to later this year.
Early in 2021.
Absolutely convinced these studies.
We remain committed to moving forward with the safety and well being of patients and investigative sites deaf ears.
It's all a top priority.
Our current expectation is that these studies should treat out in the first half of 2022.
Once we can gauge the pace of involvement doing the ongoing pandemic.
We will be able to provide updated guidance on the anticipated timing of the results from both of these studies.
Finally, let's touch on and why it's full fights age for the treatment of copies you can tell me.
We call it we initiated our first inpatient phase two exploratory study.
You know how did in 35 patients with mild cognitive impairment.
Associated with Parkinson's disease.
In light of to cope with my team can damage. We suspended this study due to the vulnerability off this patient population.
And because the design requires patience to undergo fleet insight into actions to assess cognitive performance throughout their trails between.
As we take all of these factors into consideration.
Determining the best pass forward.
To evaluate the effects of invites full fight for eight on coffee different Kim.
And expect to provide updated guidance on our plans and timelines.
It's a future date.
We remain incredibly excited about the potential of invites for fights age.
She has shown very compelling data in various models of cognitive impairment.
Including the Mark we brought us.
Oh coped interest deficits demonstrated in a highly concentrated boat non human primate model.
Despite the significant setbacks introduced by corporate 19.
I'm also pleased with the progress we have made in advancing our innovative pipeline.
With P. GST data expected in the fourth quarter.
And the resumption of our studies in chronic pain.
We expect three important trace to read outs from our pipeline over the next 18 to 24 months.
We're very excited about the potential each of our product candidates house.
To address major unmet medical needs in treating devastating CNS disorders.
With that I.
I'll now hand, the call all but two ashish to discuss our second quarter financial results.
Thank you Norbert.
With respect to our second quarter financials, starting with the balance sheet.
We ended the quarter with $115.9 million in cash cash equivalents compared to $98.8 million at December 31, 2019.
We expect this cash balance fund our anticipated operations into Twentytwenty too.
Enable multiple phase two clinical data read outs.
Revenues for the second quarter of 20.
2021 zero point $5 million compared to zero point $9 million from the same period in 2019.
These revenues were related to our research collaboration agreement with Allergan.
Which is now a wholly owned subsidiary of Abbvie.
We do not rely upon these revenues to fund our operations.
And consistent with the terms of the research collaboration we expect research related payments by Allergan throughout the next to come to their contractual conclusion in the third quarter of this year.
The majority of our spend for the quarter was focused on research and development.
R&D expenses were $8.4 million for the second quarter of Twentytwenty.
Impaired to $9.5 million from the same period and 29 team.
With the Recommencement of arc to chronic pain studies now in sight.
We expect to see some ramp up in our R&D expenses in the coming quarters.
We reported Gionee expenses of $4.8 million for the second quarter of Twentytwenty compared to $4.2 million for the same period and 29 team.
The slight increase was primarily driven by noncash stock based compensation expenses.
Our net loss for the second quarter of Twentytwenty was $12.5 million.
Compared to a net loss of $12.1 million for the same period and 29 team.
With that I will turn the call back over to Norbert.
Thanks, So she's.
Before we moved to the Q and a portion of the coin.
I would like to express all a sincere gratitude to the patients and investigate does.
Involved in putting Indian alone and double a page two P.T.S.P. study to a successful completion.
Hello.
I want to express our appreciation to the health care professionals working diligently to treat those in our communities affected by called it 90.
The second half of this year promises to be an important purely for the advancement of all clinical programs.
Moving on to close out to all our ultimate goal of cleaning novel medicines to patients suffering from this all just off the central nervous system.
We look forward to keeping you updated asked me to commence I'll, let to quantify pain studies in the coming month and.
Importantly, how should we be points data from our PTSD study in the fourth quarter.
We will be happy to begin taking your questions now.
And it is time or let's remind everyone. If people want to ask a question. Please press star one on your telephone keypad again, it is star one well pull through just a month compound keeney roster.
Your first question comes on one of <unk>, which was security.
Hi, Thanks for taking my questions and thanks to the warm welcome and it's really nice to see that the studies will be getting back on track soon so for the phase to be at than I thought them Algea and painful diabetic peripheral neuropathy study is there any reason why SM studies resuming.
Earlier than VPN, and Dan, but later that about what percent where do you see in terms of enrollment prior to the study policy. So that we can get a sense as to.
How much more you have to go until you complete enrollment into data read out and I have a couple more questions. Thank you. Okay June things things and I will actually delegates questions to the team as we go through these bad I guess Christian set up being asked let me just say regarding the studies that we put on pause.
You might recall that we had shortly before the pollute.
It's a bit the Diplock. If you will then decided to a pause enrollment we had been mostly busy was basically getting sites up and running and screening patients. So the number of actual patients in long Beach that also finished this study is relatively small.
But we'll be policy will fall out another business outs, we complete these studies.
But but the number sorry, it was relatively small I won't give specific numbers.
Basically we had just be gotten really.
Sure Bob and then I think decided to pause for all the leases up you have communicated peaceful before Kathleen can actually address.
The question of why Fibromyalgia first in TPN second.
And so I handed over to here now.
Thank you Albert.
Norbert described our general way of thinking about the pause and restart which really has two main components first is the patient population in the study and then second is the demands of the study in terms of visits and procedures and things like that.
And so I think we were able to make some positive changes within our chronic pain program to simplify or study designed to streamline procedures all with the understanding that we're working in a called it environment that requires certain protections for patients and also the investigator staff.
Well I think things are different has to do with the patient populations under study, we felt pretty good about our ability to restart with microbiology to burn patients into the clinic and to find patients who are willing to come in I think we needed a bit more time to understand the emerging data relative to cope with 19 risk in patients with diabetic peripheral neuropathy, Oh, we've done that careful analysis I think.
We feel good about our ability to start but those are slightly offset for that reason related to the patient population.
That makes sense I, I think diabetics or increase was for a cold in 18, so that that makes sense.
Regarding our you know your PTSD study, that's expected to read out in fourth quarter, while we await the data patiently is there an independent biomarker placid see that you are tracking in addition to perhaps five and other a second metric assessments I mean, because the ability to improve your plus.
He should be a good thing whether you impact perhaps five were not so while we are waiting the results and the primary endpoint is caps five what else are you capturing and the ongoing phase two that will help you make a decision on on a passport. In addition to caps five results and I had one more question.
Great Great June I, let me just make one comment before I ask Andy to address the other questions. You had asked you know promo fibromyalgia study that we successfully completed already.
We are very interested in buying omakase out an objective measure of mechanism of action target engagement and patients plus points to our set up piece.
Hi, My Alger that most maybe between <unk> and clean was supposed to pick to looking at Hyperconnectivity on cranes, each investment has elevated to the mid level.
We did not a use that biomarker in P.T. as the because there isn't one that is a generally agreed upon.
I thought biomarker that guides us Mrs pegged to the disease and we had all have you done target engagement studies, so we didnt need a biomarker for that purpose.
That's just as a pre launch and because it's less [laughter] clusters of caps I said next time.
Yeah. Thanks students so.
The measures in the study are clinically focused so in addition to the caps five we have a number of other endpoints.
PCL five measured of sleep mood cognition and so on.
So we're not specifically measuring a biomarker of plasticity. This study.
There's a couple of reasons for that one is if you recall, we did a study with two nine to five will be did look at Biomarkers electrophysiological Biomarkers, a plus density in healthy volunteers.
And we saw very positive resolved. So I think we are generally aware that our compliance do modulating the NMD pathways and human subjects that we do enhance plasticity and so I think we've established that at least for two nine to five 'em, we feel as though it applies to two are off to all of our compound.
The key question, though as you know do we impact the type of plasticity in the medium prefrontal cortex specific relates to fear extinction, and PTSD and there isn't a unfortunately, a specific biomarker for that really other than to to measure clinically what were measuring.
You know some people have looked at things with historical reflects and things like that but I think we felt that this study given the size that we wanted it to be in the population. We wanted to enroll is best focused on the clinical measures, which will be I think the most informative. So so whether we impact plus isn't the I think we feel like is it was.
R&D demonstrated that our mechanism.
And the key questions. We're looking at him of study are around around clinical outcomes.
Right. So the question is.
Yeah, I would I would think and correct me, if I'm wrong, but I would think that improving your plasticity. Good good thing.
And so what what is sort of what is what else is out there that could potentially captured that benefit. She thinks that is a benefit <unk> Pts these one but a and caps five is one assessment, but I'm just thinking you know something like this.
Do you envision doing a pet study or some kind of it.
Yes imaging to two functional image to to get at potential benefit of <unk>, maybe I'm getting down to read too much into rabbit hole, but then that is one question I had the other question is whether in your healthy volunteer study were there any anecdotal evidence of improvements and cognitive functions.
Such as we call or anything related to that thank you. That's it. Thank you.
So to take the first part I think you know there are lots of things that you can do in terms of more mechanistic type studies, but like I say I think we feel as though we're kind of passed that point and development, where we are not questioning whether the drug binds to the target and one of the target as activates a critical question is because the target.
Pathways are fairly widespread in the brain. So the specific questions that were on stirring or do the findings that we have in preclinical studies will be showing that this relates to a particular phenomenon tied to a particular disease state.
That is has also seen in human subjects. So it. So so yes, there's lots of those types of studies that we can do with pet scans or anything else, but I do feel like for the 73 program. You know we are we are really focus now on on more close to regulatory approvable.
Endpoints I clinical endpoint.
Oh.
Sorry, the second part the question was.
Oh, yes healthy volunteer study yeah.
Sorry.
Right right. So so there's two types of for 73, the healthy volunteer study, we did was a traditional phase one.
Single and multiple ascending dose type studies and in those studies I would say we had a very strong safety profile. We didnt see many advanced reported adverse events reported at all and there wasn't you know anything like a a you know widespread anecdotal reports of any.
Cognitive improvement I'm not sure if we would've expected that frankly, it's quite often that type of study to see that so I I don't think that was likely in the first place but in terms of the healthy volunteer study I was just referring to but to nine to five so obviously different drugs, but still within our platform.
That we.
Without going into all of the details and those studies here I think it's fair to say, we did see significant evidence of improvement and plasticity and some evidence of improvement and cognition in healthy volunteers.
Thank you very much.
Your next question comes on line of Charles Duncan, what Kantar, it's true.
Hi, Thanks for taking my questions Norbert and team congrats on the progress in the June quarter, Despite a lot of challenging.
Aspects of the environment I had a couple of questions and seven eight screen with regard to the PTSD study I guess I kind of wanted takes a.
Little bit different approach and what was just hsas and that is since this is a really meant to be a signal seeking study and its empowered to demonstrate efficacy I guess I'm wondering what would really define a study that did not provide just say don't would it be of lack of dose response or.
In the inverse dose response or a lack of consistency across changes.
In terms of cats, and the secondary endpoints I guess I'm I'm kind of wondering why you would see a signal here.
Oh, you know what I.
Maybe I stopped.
Charles Thanks, Thanks for that question.
I I think that our preclinical data is particularly focused on.
On few extinction.
And the underlying or what would cause shelf whats click S.P.T. as key and so for US it's really looking at caps Pfizer into clusters of caps five two coal age mechanism of action of seven eight suite with clinical elite thoughts in outcome.
And to get to send off.
Also of course, although we only have two doses seem to study, but we choose our dose is really very thoughtfully based on.
But when they do preclinical data, we see a staff levels in healthy volunteers.
So I I hope.
That you would actually right in saying days all at least once we have that you should pick up seeking goes a long caps five for the subclasses of kept fight and in the secondary endpoints.
We just want to make sure that both sic codes aligned with how we believed that lock is active and then informs US we have done with the DPN study informed as I mentioned in this case they design off the next studies. They asked us. So that is how we actually look at this mix was picked to it being.
It's picking that seeking exploratory study.
Along those various packaging and test is evaluating.
Yes. That's helpful. Thank you Norbert and let me ask you I guess the follow on is have you actually design that second that next steps study and and can you lay it out now in terms of you know very bright broad brush stroke.
[laughter] would it be a multi dose study and what kind of duration would you look at I know that it really needs to be informed by what you see into the ongoing study, but any any thoughts on what next steps could be and if that could be in started in 21.
So great things you would think your chart. So as you know from previous discussions we've had we very much sort of like data driven in how we actually do you analyze and they didn't fall next studies and so that will be the same here. It will be the question, though what do you say really lucky killed Nick set tops.
Like parameter probably next w., what that can be clear about which and I'm glad you asked that is that the next study.
We'll be a longer duration of daily treatment into Colin study, which is a four week study.
A full week study in our experience is shoots to actually do exactly what these studies asked to do namely show. It's good to talk is active.
That's much more aligned with regulatory requirements.
Yes, we have we did all a chronic pain studies this would be at the next study a 12 week study.
That's pretty much the own de sort of like framework I can give you will be called cycles client dose level and so on patient profiles would all be device from what you learned in this first study that we do.
And yes, the answer to when do we anticipate kicking off that's next clinical study.
And quite confident that did as well we see into 2021 type thing.
Oh, Okay. That's cellphone one quick one on 292 sides and I appreciate you taking all my questions.
As I think that Catherine pretty well laid out that you're considering the risks of.
At the DPN patient population have me may have to coated but I guess I'm wondering I'm not sure. If I heard it clearly was was there any change in enrollment criteria with regard to hydro My my Alycia sample.
Great I get the spectrum caps and she can she can elaborate on that just a little.
Yeah, I think no substantial changes to what we're looking at fibromyalgia, we thought about ways that we could streamline the screening process, perhaps to allow certain elements can be done remotely as opposed to on site, but that has to do with more sort of safe operations and actually the definition of our patient population.
Oh, Okay. Thanks for taking my questions.
Thank you Charles.
[music].
Your next question comes on line of Marc Goodman SBB Leerink.
No, but I was wondering if you could talk about.
Fibrosis and the TPN studies, so when news report out in 22.
Let's just presumed that they're positive so before each be what you consider to be a pivotal study such that you would need one more for each of the indications is that how you're thinking about and is there any thought process into starting another study before you finish any of those.
So as I just answered my things for the question by the way I think it's really it depends on on the data like we designed the study as you know.
To be a 12 week study.
We designed it to house.
Daily pain now see this is the primary end points all of that is consistently smoked F.D. He's looking for accident in case. It is actually a study that can serve as a pivotal all country station twice. So and then it would just be a question of watch watched us the data actually say you wouldn't be unblinded.
And analyze the data at this point.
I think we have aggressive enough timelines to try to get to problem al just studies done yes. We did we still keep haven't studied prior <unk> and a 50 short periods of time and the TPN studies that shortly after I might covenant I'm I'm I couldn't guidance would be that people wait for that.
So I don't know studies understands the data and then just costs what the agency, we'll be looking forward to take us to the finished.
Okay fair enough.
And again, if you like to ask a question that a star one on your telephone keypad.
Your next question comes on line of Gary Nachman, B M O capital market.
Hi, guys. Good afternoon back on 73, and PTSD just discuss your comfort level with the quality of the data and that seems to you've talked about the hard work you're doing monitoring patients doing pre and post cobot analyses the jury encoded.
I guess I'm, assuming different sites can maybe be doing things differently. Some virtual maybe some in person I'm, especially now that things are opening up a bit. So how can you ensure the consistency those data just talk about some of the things that you put in place and if anything has changed on that front over the last few months.
Great. Thanks, Kevin I'm going to help Katherine address that.
But just so that you remember from previous discussions by the time cold with my team heat rebuild maybe 80% involved in that study. So the bulk of it was basically done and therefore, the Covitz 19 call you called it impaired potentially in period to period of time, if we'd be all your fault.
But you know if the patients that we needed to complete and Kathleen Kennedy, that's what we actually had pets to acoma gauge and to what extent, we needed or didn't need to rely on those modifications dueling called at night.
Yeah, I think in the earliest days the pandemic, we weren't sure how much accommodation would be required we did allow for some remote patient visits we allowed for a delivery of study drug and what we found was in many many cases other sites were taking care of these patients were motivated by a need to provide support to those patients.
And so in many cases visits happen the way, we would've expected them to pre coven onsite with full data collection now we are very carefully monitoring whether there are missing data or whether there are variations in the data, but in general what we've seen as is excellent followed by the sites.
Good quality data that'll be fit for purpose for analysis.
Okay and.
And then just one follow up I know the phase two data will inform you in a lot of ways, but I think that's something that you said it in your R&D day, you know improving avoidance behavior might be more challenging to show as opposed to response and intrusive thoughts so could it be hard to tell if it's more the dose for the duration.
And that's the issue if it plays out that way and would you need to show that avoidance behavior potentially in a phase three even if you don't show it in the in the phase two thanks.
[laughter].
And do you want to take that.
Yeah I mean.
I think it's a good point that we'll have to bear in mind the impacts of time as we as we draw conclusions from the study data.
So I think someone asked earlier about the number of doses in the next study and I think that you know that's a factor that will bear in mind, there's no. Even if one dose for instance looks very much more attractive in this study will still have to bear in mind that it was only four week study and that.
The profile of clinical response, you know may maybe different overtime. So I think that's a reasonable reasonable point you know I do think that avoidance is very important symptom and PTSD.
But I don't know that there's an algorithm you know that says that you know it's necessary to show and effect on on all or any specific domain. If theres an overall effect. So I think that our assumption at this point would be that's.
The most are the most appealing path forward is to show an improvement in caps overall I think our expectation is over time that may well include an improvement in a bottoms. It's two questions on the 20 in the cap scale I don't know that that's necessary anymore than any other some domain in any given patient essence every I think we're looking for an overall pattern.
Clinical improvement.
Okay. That's helpful. Thanks.
Your next question comes from one of route to borrow what Cowen.
Hey, guys. Thanks for taking the question well start with.
To 95, and the we commenced trials.
We starting the protocol with any amendments to allow for footnote assessments and are you will allowing for increased levels of drug supply at the patient level.
In their progression to allow for any future Kobin machines late this year next year.
Okay can you give acute.
Yes, so we are carefully and looking at the way that those studies are gonna be conducted a I think what we are balancing the need for safety follow up on together with the need to provide remote options for assessment in the event they called it becomes more difficult.
I don't think were particularly looking at increasing study drug with patients, but we are providing waste for remote follow up to be done in conjunction with onsite business that are needed for safety parameters.
I think we've also streamlined at the procedures that are required for this oh, which will make it easier both for sites and patients to conduct those vincent visits in a relatively efficient and safe manner. I think that's been our general approach.
Pablo study I haven't got protocol modification I'm, sorry, Oh, you asked about protocol amendments both studies have amendments that allow for these changes.
Got it.
And the upcoming teachings consent and now that you're getting close to database lock I'm, assuming the statistical analysis plan.
Finalize Tom as it stands now can can you walk us through what exactly prospectively as secondary analysis.
What you guys see at the most important either secondary analysis or secondary endpoint.
That would support.
[laughter] topline capsize data.
Yes.
Okay, and he and the team kinda level, they picked up but I think we always do you find to be tool by saying we have kept flights score as a told it's cool.
We have this how clusters of caps flights that it's less particulate domains like avoidance intrusion of always.
And yet and we are going to analyze.
He does help domain.
And to better understand how they contribute to the total cap school changes that you're looking for and then indeed mentioned earlier I think that you house secondary endpoints with respect to move sleep.
Cognition and so the kids to get another this plan, we provide for us to actually assess the study resides along those fairly asleep college as primary and secondary read those.
And index will DECT ULE, then they basically give us the information we are looking for that to inform the next W. After a month.
I'm not sure there's much we can add to that team.
You can also comes to mind.
The only point I would add just to maybe set expectations as you know the design of the study the number of endpoints and also some of the parameters that one could use to segment. The patient population does result in multiple dimensions, you know that if you sort of multiply them altogether creates an enormous.
Number of possible analyses. So I think we've tried to pre specified some critical one.
But we have not deliberately.
I tried to pre specify absolutely everything that we think may or may not eventually be interesting to look at so I wouldn't be at all surprise. When we are communicating the data if if some of the insights are not pre specified and that's kind of intentional and by design given given the startup of the study.
Got it can you talk to the specifics scale that you're using at least for moving cognitive function.
Great and population.
Oh, Yes, Oh.
Yeah, maybe one under why didn't you got to take that are you willing.
Sure for movies, where you've seen they had a hospital inside and depression scaled back then so rating scale that obviously.
You know says its symptoms and to a different conditions.
And for the sleep, where just the Pittsburgh sleep scale.
Sneaks to.
[laughter] times to bed.
So yeah, the number of hours bad satisfaction with the quality of the sleep so pretty.
Rich there.
For companies actually on the you've seen one pass it back.
Hmm bodies and.
Kinda loaded toward executive function.
What could memory.
What kinds of of functions.
And [noise].
Yeah, but those are the main African.
<unk>.
That's perfect. Thanks, so much of the color.
Yep.
Your next question comes on line of Laura Chico with Wedbush Securities.
Hey, guys. Thanks for taking the question one of course on 783.
Could you just remind us a little bit about the safety.
For 73 and by that I guess, I, specifically, we're I'm talking about chronic tox data and how much chronic tox data do you have now that do you have coverage that would permit longer dosing beyond four weeks and then a quick follow up you're generating a lot of different signals a one thing.
And that came up at the PTSD event was with Dr. Steen psychotherapy and that being really a mainstay current standard of care. So that's one thing you're not really examining in this study. So I'm curious how you're thinking about incorporating psychotherapy in future studies or if you think you need to thanks very much.
Okay. Thank you lot. So we are going to help Orlando is less safety close we of course, we pulled it on that developed phase one resides as well as won't be currently can glean problem that phase two study and then and he can speak to talk and ER.
I will talk supports longer term studies. After this four weeks, but let's kick it off one of the Adobes Jesse can be chip on phase one.
Certainly so.
The pattern was extraordinarily benign they were.
Exactly to adverse events reported that were deemed related to their drugs for TV in headache.
And really nothing else.
We were measuring in volunteers also dissociation.
Dedicated scale to there was no signal there the lab, where also clean as we see.
And in the ongoing Oh study in patients. We also have seen you know mild to moderate adverse events, we will be able to tell you there.
You know they.
You know that related to decide to Gracie then you know to treatment because we remain a blind, but again it benign.
Thank you Andy.
Yes, there were Laura we're working through and I have completed many of the necessary steps to be to be able to enable that the longer duration studies that that we mentioned so currently our plan from a.
From a toxicology point of view as to be able to supports a 12 week study in the next stage for instance, and we'd now like I say, we completed most of bad work, there's a few.
Study is still in process all of which should be wrapped up you know in time for early next year. So so yeah. That's that's definitely to plan, we've not done yet.
Long term six nine months talk studies, we were planning to do that as part of the next stage of development <unk>, obviously would enable.
Even longer term clinical use.
So I think there was a psychotherapy quite well, which oh, yeah, if I can just.
Just just briefly weighing on that as well that would be the whether or not we would benefit from or it would be valuable to do a study with psychotherapy. It's definitely something that we are thinking about it or we thought about that I thought about it in the past you know there are some challenges and on incorporating psychotherapy until clinical trial. It has to be standardized obviously.
Has to be synergistic with what the drug.
And of course for from our point of view. It also has to be something that data as a mainstream clinical utility.
And and and the value and so those are some of the factors that will look at all but I think the Norbert pointed earlier, we would probably really be guided by the data.
And I think it's fair to say that if the data supports pursuing a pop.
Where we don't or you know examine the drug and alongside psychotherapy, we would pursue that boss. Yes. In addition, our instead of that it looks like it's a good idea to pursue at and intend to my psychotherapy. Those are the kinds of things said, we'd be thinking through.
Thanks, very much guys.
But no. It just took two also said that make blunder additional point you really intense maybe also makes this a mono therapy to a to be able to assess.
These they'd be effect of seven eight suite and its own white before we actually.
Do stroller complexity for example by a combination was stuck with that.
Got to answer your question a lot.
[noise], yes. It does thanks very much Robert.
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And next caller. Please take your first and last name.
Mark from H.C. Wainwright.
[laughter].
Hi.
Well in all but one thing I'm on for Rob. Thanks for taking my question and congrats on your continued progress Oh, we have a few questions shrunk.
Quick Smokeable.
True though.
With 73.
You have in clinical development plan to assess 73 and alcohol use disorder.
So would it be possible if you provide any detail.
So thank you for that question, we as I mentioned Holscott.
PTSD on D bench or doing rich and don't always fix doing which indeed, we you would go a very comprehensive preclinical data sets and I'd like seven eight speed.
And a significant part of that status and indeed.
Related to a substantial alcohol use.
And to be how some we did you give you a compelling data.
That show a clear benefit of seven eight speed index, because all of them.
Definitely not only hope would you contribute to what we are looking for ongoing PTSD study, but lends itself very nicely to.
Considering a separate independent development path in the in that indication.
And so why do we have not yet mix that's all.
Oh finalize that clearly among other choices we have.
With respect to CNS disorders says all related to it and be able to tiptoe abnormalities, we probably got to be not only attractive enough I, probably only keep I thought so well supported by or we can.
Okay, perfect, we would agree that an exciting pipeline opportunity.
In terms of assessing sleep metrics in the PTSD population.
What would happen through a separate proof of concept trial makes sense to you.
Do you feel that simply incorporating the P.S. couponing outcome measure in the future trials sufficient I guess, one stop asking is Doug do you think 73 has the country utility in the insomnia population.
Yeah, It's a really really good question as well and I should mention debt, we have done now, especially and you alluded too if I if phase one and healthy volunteer study maybe measure sleep.
That's data supports our preclinical data, which we can consistently show for our modulators that they improve total sleep time as well as amendment longer than sleep.
Oh to know when do you look at the commercial opportunity and the unmet needs.
We have not do we really felt very bullish about a separate indications in insomnia fall or components, but clearly we believe that has a co morbidity, namely sleep.
As a co morbidity to chronic pain to move too so all those two P.T. as Steve.
It is a significant component of what we believe to be a more holistic approach to addressing the underlying root causes of these results these diseases and.
That's probably where we believe it so no I and he can comment because you have on so.
Commercial that analysis as well.
But I I don't think at this point insomnia itself, it's up high probability Paula.
Yeah, I think I think that's right.
I don't think we're trying really on the study to establish that there would be a independent kind of proof of concept and insomnia. If the data on sleepers, especially striking that maybe something that we might consider but the purpose of the Pittsburgh measurement is to assess sleep in patients with P.T.
Steve because of the particular issue.
Stations.
[laughter] color or and speaking with 783 Npts D could you comment perhaps on any school that you might get from government agencies, such as Ah Department of defense and what your plans office seeking non diluted funding from Salt School.
Such as though.
I'm not looking at the team here, maybe she shoot me do you think it.
Yeah I was so Oh, we have had really nice interactions with a number of.
Advocacy groups, both governmental and nongovernmental across our programs.
And those remain very important relationship as we seek to too.
You know maintain a good perspective on unmet patient need access to.
To patients and and and also funding.
We have engaged in.
Engage with certain sites in our PTSD study that our VA affiliated.
And you know, it's especially in a cobot 19 environment that that can be especially challenging with regard to endorse for some of those sites.
Well, we have not seen the need a yet to to seek or or or pick them funding from the Deo D.
Support of Ah. The studies, we we think that the data.
From our first exploratory study to discuss discussed extensively will inform you know what sort of a impact you might expect on the symptoms of PTSD and maybe informed such discussion as to how supportive agencies might like to support our efforts, but at present, we were focused on a on funding.
These studies directly and that's probably capable of doing so.
Okay. Thank Chris we and I'll squeeze one final one and I suppose it wouldn't be a.
In school that could be question.
So for the full fivei in Parkinson's disease.
I was looking.
And adopted Moca test a that's being used for remote testing would you consider something like huh.
Okay.
And your luggage extend though.
Yeah.
It's a it's a great point, there definitely wouldn't be ways to assess cognition remotely I think our concern as though that if you remember back to the original intent of the study. We were we were using measures like them, okay, but they were they were incorporated alongside much more detailed.
Neurocognitive assessments scales that we're on.
No we're a number of them.
The purpose was to really give us a very nuanced perspective on what it is not the drug can do from a cognitive impairment improvement point of view that that potentially you know kind of company Uh huh.
Good effect on on more scalable instruments like Okay, and I think our concern as those that's still a what we would really like to accomplish and those kinds of neurocognitive tests are very difficult to administer remotely there are a lot of them.
And they just don't lend themselves to that so I think that's part of what we are grappling with as we as we think about next steps. It's not just you know the patient population in Parkinsons, which obviously is on older population and and at higher risk of koby complications but.
But it's also just how do you do that kind of more granular in depth cognitive assessment in a way that as.
You know more suited to this environment. So work you know we are we are working very actively on this I'm considering a range of different options cognitive impairment is still a critical domain for us. So from a long term value creation perspective, we still are very committed to a exploring that and I think we're hoping.
Hi that we can give more guidance on more concrete plans in the near future. It as it has a topic a very active current work on our side.
Thanks, Andy I can appreciate you don't want to compromise on the quality.
I'm sorry, that's fine.
You have any updates on how can you just have to target. So how can you indications are exciting.
In the coming coming months again.
Can you repeat the question.
So I just wanted to get to General General question. If you had any new update on new receptor targets perhaps.
New indication when Youre stuck modulation Oh, sorry.
Yeah.
So.
The work that has been done over many years by many many lapse academic labs as well as industry labs.
Clearly shows that and then be a receptor.
Pivot shows not only for normal Blaine function, but involved in Hawaii to lay off CNS disorders.
We have Colin de prioritize P.L. together that we work in chronic pain PTSD as well as cognition cooked cognitive impairment.
I.
I think it's only a metal when we actually expand further and beyond.
You just talked about alcohol use disorder. As one example is there other stuff we are very very interested in because the data guide us be a into signs guides us there.
But at this point I think our primary focus is on deliberately.
On the on the phase two pipeline, we have while at the same time.
Continues all preclinical work to advance additional compounds into I in P. States and I thought I'd adult.
And so if new indications or for the existing ones, we find to cultivate adjacent sees any additional indications.
But that is here to get further out into future notch topped by all the kids is maybe more.
Great. Thanks, very much Nova Katherine they can be in Roland Congratulations again, thanks for taking my question. Thank you. Thank you very much.
Your next question comes on line of miles one minter with William Blair.
Hi, guys. So thanks for squeezing me in just a question on the Fokker Mylan two trial obviously.
Improvements in pain is a primary factor XI, but.
We've been seeing things like to take one extra day differentiating factor compared to what's currently approved out there it's a bit of and I had question, but I'm wondering whether patients it takes and maybe if and quality of life.
Dealing with this this disorder has actually improved considering patients come sometime during this time and probably outsourced guy to work can access themselves as much.
Are there any is there any evidence of dot and second and secondly is there any inclusion exclusion criteria.
In that ties to the trial that wedding show that you can actually enroll patients experiencing a symptom. So you can measure a treatment effect, which is.
Okay. Let me maybe make this is opportunities just remind you might say and I think you talked about that before this problem. I was just study we did which was a biomarker studies combined with.
A pretty widely off like subjective patients to be positive data clearly shows not only a statistically significant improvement in pain scores, but also in the problem Alger questionnaire, which addresses a large component of quality of life.
For these patients and in the improvement of sleep quality. So we know we know that our compound is active caused.
That spectrum off or infants that define fibromyalgia.
As to what extent to killing patient population has changes in its sort of like perfection. All in doing so that he is off these impairments.
Reverses Kirkland is going to stick to cope with 19 I.
I have no information on that maybe Orlando you have any thoughts on that.
Something that is likely unlikely SB sort of course heating.
Yeah thinking over.
Very safe sub scale of common.
<unk>.
Sure a team that we are flying.
And my Anja.
Study, so we will be able to.
So I forgot question.
No it wasn't like say no I.
From the previous.
Study, Yeah, we would expect I'm sorry.
To me.
[noise] like HEICO, and then just stay very fun it.
In terms, if your involvement expectations for the painful diabetic neuropathy trial.
I know you are enrolling a chronic safety and patient population.
Just wondering whether these patients at high risk, it's covered non Chinese section compared to the generalized DPN population and whether you will see any impact on the cadence of involvement of that particular population relative to other TPN Charleston might be going on out there. Thanks.
Oh, So we are looking as we discussed at patients that have had chronic pain diabetic neuropathy for a longer period of time.
So painful DPN.
I think diabetics more broadly speaking about the population density is quite yet.
Relations was higher by another ability to cope with 19.
Okay, and I think I want to a path to be has kept couldn't point is always to make sure that not only the design of our study, but also the conduct of on site.
Investigative sites provides for safe environment for patients and minimize is not necessarily exposure.
Sorry.
And that's probably as much about my concern that we are not at all at the end of corporate 19, and if we need to assume that we will be conducting these trials in an environment, where Colgate 19 will be an ongoing concern that be all should have.
And that's part of how we actually thoughtfully looked at this time.
To love to Washington to keeping these studies off again, but to make sure that they can you actually successfully be executed over the next several months.
And be part two and completion.
What's the assumption that Cobiz 19, he's going to be part of US one going all the other here in the U.S.
Yeah, just to briefly at I think you know the question on duration of diabetes I don't think there's yeah. It's very clear indication that that's an important independent factor. We've kept track I think quite carefully of the day. So that's come out and I think if someone mentioned.
Earlier, we feel as though a lot of the inclusion exclusion criteria that we have already had in the protocol for safety reasons to do with a you know limiting you know reduce kidney function.
You know any liver disease.
You know H.B. I want to see laterals, making sure it as a reasonable level of Glycaemic control.
So I tried it there we already had in the protocol, but those do seem to be the factors that are emerging more from the analysis. We've looked at as you know correlate to get worse outcomes from coveted, but we'll keep a careful eye on it.
Great appreciate the update.
And your next question comes along of Jim Lee literally securities.
Hey, guys and thanks for taking the follow up question I just wanted to clarify couple things for Tonight to side I think Mark asked a question and forgive me if I Miss heard but he asked a question assuming that phase to be NN fiber Malaga studies will be concluding in 2022.
Is that expected timing for study completion, I mean sounds reasonable, but just wanted to confirm.
Oh, Yeah, no glaze I'm glad we can actually address that so we.
We have a really good sense for them to previous P. and study.
To watch the close of enrollment and duration of enrollment would be like in this study like that because we've done it all vicki.
We don't know exactly what the new environment, It's mix was pictures type.
And overall environment in a cobot 19.
Got you Asian, and so we offer such that we can provide better guidance on projected.
Completion date, well first of all of them and as we go back into the study engage the enrollment rates that we are basically seeing.
And can be provided for now a time not that says.
The coal consumption. Good we are making first half of Twentytwenty too.
To be adjusted in revised depending on how enrollment actually unfolds and it happens.
Try to accelerate that to a slow that down depending on the topic 19. So I've got to put there should be appears to be making first half of twentytwenty.
Great. Thank you asked for PTSD you completed enrollment you teach the studies eight weeks long. So is it fair to expect topline September or October or are there other considerations that we should be taking into sort of tightening up the top.
Yes, so we guys its fourth quarter.
So that's what we currently project because we are in the process off basically getting the data locking the database is cleaning up the data collecting the data and.
It's a projection that I think is within a timeframe that takes into account somewhat weekly meeting uncertainties 50.2 dogs.
Making sure we get all this information and get it cleans up but we moved it from the end Oh, Oh, Yeah, which we had previously communicated to fourth quarter. After we recognize that we've actually completing this study.
And we're going to hold onto that for now and.
Let's see where we come out.
Okay and last question for me is you know there's been a lot of questions around the fine.
The primary endpoint of caps fight, but could you envision a situation where the endpoint approvable endpoint could be other than something other than caps five P.S.P.
Cafs five has a historical into use exercise for approval, but given that very different mechanism of action could kind of different skill the use esteemed appropriate.
And these caps fighting validated for can PST. Thank you.
Yeah, well under GAAP.
Yeah, the cups five actually.
It includes every since then listed in the DSM five for PTSD, So who dimensions. So it is it.
It has been validated pack.
Dr analyze number of times.
And.
You know found to be a robust.
Measure.
No.
The.
The sub cluster or something close to the so called clusters, like intrusions and avoidance and negative effect.
Missions et cetera.
Those measure.
And also very important dimensions and of the disease and you know.
It actually lead to impairment or you know in functioning reduction in quality of life. So we think that and an effect in one or another.
You would be meaningful.
Work for for patients.
And.
We would have to of course.
Discuss with regulators.
What is the value.
These but no suddenly.
I think the cap side is comprehensive.
And then clusters.
I can individually silver percent meaningful.
You know.
Segments of the.
Symptomatology.
Did you see.
So let me, but just.
Oh, Yeah go ahead go ahead.
When I mentioned JV might could that be hostesses, PTSD R&D day with Dr. movies Spinola.
Maybe you can expect in speaker.
I think he wasn't really clear in Ah shielding his thoughts that the unmet need to PTC. So enormous said if we can make if anybody can make an impact on any off the clusters in its own way and its isolation.
I would consider that absolutely can you give me a meaningful and worth pursuing.
And we agree with that simply status has been completed.
Great. So is that a is that a yes or potentially a different endpoints for pivotal study.
It is as long as we can help a dialogue with the agency and the agency supports it so I cannot be pre Emptive index, because I think if he's able to sites, but I think with the right and compelling data.
They would likely be very open minded to that because it seems to make perfect sense talk to each of the communication for community as to why is it should be so.
Great. Thank you so much for taking my follow up question.
Sure.
Okay, and now back to your Norbert for any closing remarks.
Okay. Thank you off of it.
Thank you for all your questions step was actually took I think.
We appreciate your time, we appreciate your attention.
Just a C b well and enjoy the rest of your day.
Bye bye.
This concludes todays conference call you may now disconnect.
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