Q3 2021 Aptinyx Inc Earnings Call
Good afternoon, and welcome to the at the next third quarter 2021 Financial result conference calls at this time all participants are on listen only mode. Following the formal remarks, you will open the call for your question. Please.
Please be advised that the call is being recorded at the company's request at this time I would like to turn the call over to Patrick Kleban Senior manager of corporate development and Investor relations adopting it.
Patrick Please proceed.
Good afternoon, everyone and thanks for joining us on today's conference call to discuss actually she was financial and operating results for the third quarter of 2021 or press release, describing financial results Andreason highlights is now available on our web site.
Today I'll call normal Riedel, our Chief Executive Officer or review recent business updates then Andy Kid, our President and Chief operating Officer or review progress across our development programs, followed by a she's kind of our Chief Financial Officer, and Chief Business Officer, who will review the financial results. In addition, Katherine King Senior Vice President of clinical and.
C M C operations, and Harold Merck, Vice President of clinical and medical Affairs are on the line for the Q&A portion of the call.
Before we begin I would like to remind everyone to 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 any forward looking statements are made only as of today and we disclaim any obligate.
<unk> to update these forward looking statements. Please see the forward looking statement disclaimer in our financial results release issued this afternoon and the risk factors in the company's current [laughter] subsequent filings with the SEC I'm now happy to turn the call over to Norbert to kick things off.
Thank you pets than good afternoon, everyone. We appreciate you taking the time to join us on today's call.
Before we begin was updates Homo like Sydney could call them.
I would like to extend a warm welcome to Doctor give them all O'neill.
Our newest click on the ethnics board of directors.
Talk to a new has extensive experience in CNS talk development.
Because they make medicine and as a practicing neurologist.
He currently serves as executive Vice President of the father D and Chief Medical Officer.
Sure It takes.
Where he leads the company's research clinical development Medical Affairs.
Pharmacovigilance and regulatory affairs function.
He also putting some impressive spec honed in late stage CNS talk development.
His previous 15 year tenure pyrogen.
Where he has leadership halted because numerous programs allergy.
Pain.
Gene and fell therapy, and clear diseases, including all those type of numerous global marketing approval.
I am confident kinmel will serve as an invaluable resorts in helping to guide our future development and growth plans.
And we are thrilled to welcome in Louisville.
These past several months have been a particularly productive time Clapton.
And we are looking forward to an active purely it of execution and multiple of data.
Right.
Later this year, we plan to initiate our fate to be development pull them of N Y X 783 in patients with PTSD.
We also recently announced that would be expected to report results from all of his to be study of N Y X 2925 in painful diabetic political and you'll help at the.
In the second quarter of 2022.
Meanwhile, enrollment in our studies of NY X 2925 in trouble mileage up.
And NY 458 in cognitive impairment is progressing well with.
With $3 anticipated in mid 2022.
And the second half of 2022, respectively.
With this slate of clinical development programs moving full speed ahead.
We are very pleased to have a strong balance sheet.
Bolstered by a ghost credit facility, we secured during the last quarter, providing access to up to $50 million.
Our Killen capital position is expected to fund phase two did a readouts from each of our pipeline programs.
Cost 2022.
And 2020 Sweet.
We call it that's doing our last last quarterly cause.
We announced our plan to ship transition.
In which N D Kid will become president and CEO [noise].
We will consume the all of executive Chairman.
Effective generally first 2022.
The rollout of its transition has continued to proceed very well.
Cause our team is prepared to hit the ground running in the new year.
I will now turn the call over to N D to dive into more detail on each of our programs.
Beginning with N Y X 2925 and clinic paid.
Thanks, Narva and good afternoon, everyone.
Is norbert highlighted earlier, we're very pleased with the progress made over the past several months.
Cross both of our chronic pain studies.
In October we completed enrollment in our face to the study of N Y X 295, and patients with painful BPM.
The pandemic environment is clearly presented challenges across our industry can take them only for clinical research Nonetheless, our team superb execution and the engagement of patient some sites over the course of the past year has enabled us to complaint enrollment at a steady pace.
Recently enrolled patients must complete the 12 week treatment period, followed by a 30 day safety monitoring period.
And then expecting to report Nathan from this study in the early to mid part of the second quarter of 2022.
This phase to be study is predicated on data from my previous phase two study in D. P M.
And the prior study N Y X 295 showed the most robust effects in patients with more chronic disease consistent with it centrally acting mechanism.
Based on those results, we enrolled patients in the face to be study, we've been living with painful D. P N over a period of four years or longer.
I also did an awful lot of patients to take concomitant analgesic medications during the study.
In the prior study, we still a greater ability to the tech efficacy and separation from placebo and patients who were not on background pain medication.
The primary endpoint of this study is the change from baseline and the weekly average of patient reports of daily pain evaluated over 12 week period, using the zero to 10 point numerical rating scale.
Well. This is a phase two study this primary endpoint and the study duration are consistent with typical registration studies for neuropathic pain.
Therefore, we believe the data from this study should be highly informative for further late stage development.
In addition to the study and painful VPN. We're also conducting of things to be study in N Y X 2925 and patients with fibromyalgia. This.
This study is evaluating two dose levels of N lamps to 95 and has a larger enrollment target approximately 300 patients versus a target of 200 and the D. P. M study.
Enrollment in the Fibromyalgia study continues to progress well, we expected to read I made 2022.
Let's start ninth and my ex for five days or product candidate and development for the treatment of cognitive impairment associated with Parkinson's disease, and dementia with Louie buddies.
This is a program how 'bout, which were incredibly excited given the strength of our preclinical data with N Y X 458, and translatable models of cognitive impairment.
Furthermore, we've recently seen an enhanced enthusiasm for development of new therapies for cognitive deficits associated with Nero degenerative disorders.
And my ex four five age is currently under evaluation and a first inpatient exploratory phase two study to assess safety and Tolerability.
To detect therapeutically relevance activity on cognitive deficits.
Lightning specific measures of attention memory and executive function.
This double blind study is comparing a 13 milligram dose of N Y X four or five eight with placebo and approximately 100 patients with cognitive impairment associated with Parkinson's disease or dimension with lewy body over a 12 week treatment period.
Enrollment in the study is progressing steadily and we continued to anticipate working data and the second half of next year.
Finally, we will discuss N Y X 783, or product candidate and development for the treatment of post traumatic stress disorder.
We will soon be initiating the first of two planned phase to be studies, all then Y X 783 in patients with PTSD.
This space to be program follows on our previous exploratory phase two study in which we observed encouraging improvements and PTSD symptoms among patients treated with N Y X 783.
The first phase to be study.
We'll evaluate once daily dosing of 50 milligrams of N Y at 783 versus placebo and is expected to initiate by the end of the year.
The second study, which will evaluate once daily dosing of 150 milligrams of N Y at 783 versus placebo is expected to kick off in the first quarter of 2022.
Each study.
It is expected to enroll approximately 300 patients include a 10 week treatment period and use the regulatory standard primary endpoint of the top five total score.
We believe these face to these studies, it's positive Ah well positioned for consideration as registration supportive based on discussion we've had with the F D. A.
Of course, this will ultimately be a matter for the agency to consider and decide on at a later date should the studies proved successful.
As you can see we have a lot of activity underway across all of our programs and of these areas and we're looking forward to upcoming study initiations and a series of data <unk> next year.
With that I will now turn the call over to Ashish to review, our third quarter financial results.
Thank you Andy.
You've heard from both Norbert and Andy we are pleased with the progress we've made an advancing our pipeline in the third quarter.
On the financial front, we made key strategic decisions during the quarter to ensure we are well funded and have financial flexibility through the series of phase two study readouts upcoming.
We were pleased to secure a growth capital credit facility from K two health centers.
Which provides us with access to up to $50 million in additional capital.
The capital, we have and plan to draw down under the facility enables us to fund our operations through phase two did a catalyst across all of our clinical development programs.
And extends our operational runaway further in 2023.
Let's review our financial results for the third quarter.
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 $16.3 million for the second quarter compared to $6.6 million for the same period in 2020.
An increase attributed to a ramp up in clinical development activities across our portfolio.
We reported G&A expenses, a $4.9 million for the third quarter compared to $5 million for the same period in 2020.
Our net loss for the third quarter was $21.2 million compared to a net loss of $11.3 million for the same period in 2020.
And finally, we ended the third quarter of 2021 with $125.3 million in cash and cash equivalents.
Compared to $141 million at the end of 2020.
As we head into your and we are both financially and operationally well positioned well ahead of the multiple data catalysts, we expect in 2022.
Does that I'll now turn the call back over and over.
Thank you very much though sheesh.
As we approached the start of the new year, we remain focused on continuing to execute.
<unk> all of all clinical development program.
With multiple phase two hito, it's over the next 24 months.
And then cut by his tongue balance sheet.
We will prepare us else, we apologize potentially transformative felix value creation for patients and children alike.
We are happy to take your questions now.
[noise]. Thank you if you have a task question. Please my scarf I would buy one on your bed or for any reason you would like to remove that question. Please press star followed by two again to ask a question I started one.
As a reminder, if you're using a speaker phone. Please remember to pick up your hands that before asking your question no policy of briefly as questions are registered.
The first question is from the line upgrade to Pearl with talent you May proceed.
Hi, guys. Thanks for choosing the question I wanted to ask about the next read out that's the 29 25.
D. P N study that's completely enrolled.
What is the what do you think for final since you have final set any conduct or at least drop out what do you think the final powering unsteady is which what should we be thinking around the primary endpoint I've been numeric rating scale for pain, and I think more importantly, given to change it.
<unk>.
Patients with more London, London, chronic pain no comment.
What should we be anticipating the placebo to be content to last time can then okay quick follow up appointments that'll be quick.
Alright. Thanks, Thanks for the question would be too.
I asked you could really mentioned we have discussed this with quite a number of kidney could kill right. Now is that I'm gonna have N. D gives you Oh I thinking as to what we expect this cause pick too.
Meaningful just couldn't see it and didn't and treatment cool closest placebo group.
Yeah. Thanks, Norbert you know in terms of the clinically meaningful effect I think we've all decided that anything above.
The pain score difference between active and placebo 0.5, or greater would be clinically meaningful you know, it's it's always a little bit hard to create a single cut off like that it obviously depends a little bit on safety profile I think the better tolerated the drug the lower our differences clinically meaningful uhm.
We we think we are powered you know in the range of what is it clinically meaningful signal it depends a little bit of course on the variance that we see in the study, which we don't yet know, but I think we're quite comfortable with where things have turned diet in terms of final enrollment and you know discontinuation from someone.
As for the placebo effect, it's quite hard to tell I mean, we did quite a few things in the study to try to control the placebo effect, but I guess, we want no. If that was successful until we see the data.
Got it and then there's a range of secondary outcomes listed on Quinn Charles Dot Com I think that 12, ranging from patient Brooklyn question to sleep score. Two you said rescue medication is there a hierarchical uhm analysis.
The secondary within the statistical analysis plan or can you at least okay uhm.
Uhm perspective going to restaurants, which ones you think are the most clinical name appointment.
And do you like to take that as well.
Yeah, certainly so I think we'll we'll you know we'll discuss more or I guess differed detailed discussion of the statistical plans until we until we have data to talk about it but I do think you know the the the obviously other than the primary endpoint measures of global impression are are certainly interesting.
I think some of the other measures of of pain other than just average daily pain, which we're looking at are interesting as well you know this is a study though where.
You know and you know patients.
Patients with D. P M.
Pain is really define the condition and you know a lot of weight isn't really on the primary endpoint here.
Got it thanks, Sandy thanks number.
Yep. Thank you have it too.
Thank you Mr <unk>.
The next question is from the line of Charles Duncan with Cantor Fitzgerald You May proceed.
Yes, hi could afternoon, Norbert Andy and team thanks for taking our question.
I also had a question about two nine to five and then wanted to ask you about 458 quickly regarding painful and that it and wraps. The study that is totally and rolls I guess someone for you to remind us about the no concomitant P. Maddox.
Nations and what is there a waiting period and I guess I'm wondering how you establish that that they stayed off Charles and then secondarily is there an open label extension component to that study and if so are there any in rose in that and then I had to quit.
And about the safety database that you could imagine would be required going forward in that indication.
Oh child's supposed to actually three questions.
Fix of it.
Q as.
And I think I'm gonna have Indian how about Keiko vis maybe and you can kick it off.
And through it step by step.
Yeah sounds good so I can I'll hit a couple of points you know I think in terms of the note <unk> yeah, it depends which combat of course, you're talking a bed as to whether or not it was possible to actually wash off that medication is as part of the the screening period of this study so some.
You know drugs that are more difficult to just continue it was not considered as part of the protocol patient can work with their physician separately to come off that drug if they wanted to and then after that once they understood that was required to screen for the study they could come straight into the study within the screening period. There were some of the shark directed medications.
That patients washed off over a period of up to four weeks. So that was sort of had that was was handled uhm and then I think in terms of open label extension Bill will not be an open label extension period for these studies, but we would certainly in future phase three studies.
Would expect to have an open label extension and I think in terms of safety database right. Now we have not met with F. D. A to discuss the requirements for an M. B a there is a prior guidance on chronic pain that we are using as a guide, but we we will not have.
A definitive sense of the requirements until we have an end of phase two meeting with F. D. A after data.
Harold do you want to cover kind of any more details on the.
The wash I'd period, and then how we we made sure that patients where I'm going back on that other medication.
Yeah, I mean at the end of the day you have cause money touring any concomitant vacation doing good tried uhm and <unk>. Some for some medical evening, a patient needs to get any kind of medication goods or caused something which would be applicable.
<unk> somebody would be calling the medical perspective acceptable <unk>.
Just want to make sure that patients at the same starting point at the beginning of the 20th so a note about medications I wish you all the things important to keep in mind them dead. We got that only those patients ZIP code could be considered pull to try what was this doesn't interfere with Val <unk> yeah of course.
This is all my question.
Yeah, no very very helpful. I appreciate the color.
Just hopping over to 458, if I could ask a question about the cognitive impairment M. P. D. N D. O. B are you collecting any biomarker data, including biomarker data, which is not like something you get from blood or whenever but so for example, quantitatively E T or any measures.
Brain activity in that in that study.
How about.
Sure. So itchy you I'm not looking to see if you're allergic to mock us about the number of blood biomarker. So uhm.
So I was hoping things like something inflammation Paisley Roland infused with all the all you can do both put on my toes, which may be a rather than.
So we have let's say some type of a biomarker program in place but of course, yeah somewhat limited I would think that the primary <unk> cognitive.
Computer I was told me with this test should be regarded more as biomarker with the of course kind of an extra mental approach to what people do with coordinate this function what you're trying to do at the second step is to see which opened though was computerized pulled me to <unk>.
With clinically Pyelotomy does mix, then hates us to move forward within two faced with.
And then and then a follow up to that in that patient poppy or sample are you enrolling patients that you would consider to be relatively advanced in their Parkinson's disease progression and therefore, yeah, possibly.
<unk> going to experienced hallucinations or anything else beyond cognitive impairment. Thank you I'll hop back in the queue.
Yeah, how about a extra <unk>.
Yeah, Yeah, yeah. So we basically this allow patients will not allowing people who are treated with new upticks uhm with a very small except me what we have.
Because sleep in doctrine, but not for the treatment of psychology, so patients have to be on a level that they didn't happen to know the expected to experience any hallucinations, which of course can happen Paducah invasions. This mood board the dementia regarding the.
Severity of patterns movies from a multiple spectra of of course, you have to make sure that the subject to audit taste. It's glenda on period, which can of course also <unk> with cognitive testing uhm and that is arrange if you won so off the subject we allow and one of the.
<unk>.
We just need to be in the in the investigate that is to make this assessment is how much do the modem dysfunctions in the appeal with some participation in the clinical trial, which basically means how much are these people. These patients cable bill feeling the computer has called me.
It is definitely need to call some type of multiple control. So that's a cut off which is based on the assessment up to investigate that.
Perfect. That's one of the reasons I have thanks for taking my questions.
Thank you Charles.
Thank you Mr. Duncan.
The next question is from the line of June Lee with two Iced you May I proceed.
Hi, Thanks for taking our questions.
Just based on the prior questions it sounds like patience and faith to be tied for D. P. M study needed to be actively washed out of some comment payments as opposed to just enrolling patients who are just not on payments like they weren't paid face to a post doc balances because our understanding is that and say to a VPN study.
And the <unk> analysis or you did we're in the group of patients who just weren't on common of pain meds, so by washing them out of the pain messed that they were on and stays to be.
That's.
They weren't needed to be on 10 minutes, what what kind of fight that created uhm.
Post hoc analysis and I have a follow up.
[laughter] Alright, Andy I think you can Scott six Bucks just to be clear. It is not June it's not as if we were only allowing patients.
Who wash off a can comment didn't pain medication.
We have <unk> not to begin with on a concomitant medication as well as supposed to wash off so.
Just as a clarification. So I don't know if she was so long impression on the subject.
Yeah, Yeah, no right exactly that I was going to make that point that I think the question from Charles covered if and when a patient washes off medication not not that that was the only way to get into this study I think quite a large number of patients in the study will not have been on one of those.
Comment analgesics to start with and actually as a reminder, in the last study.
There where patients washing off drugs to get into the study you were only allowed to.
On one other analgesic so I'm actually in a group of patients that.
Within the last study that we're not taking a concomitant medication did include quite a few patients that.
Uhm that washed off a pain medication of some kind I think we may have made the point in the past that a lot of them are not taking something like Abba pension for goblin blocks of team, but there were other drugs that you had to wash off and actually there were still a number of war, taking one of those drugs and and washed off.
So I think it's it's likely to be a fairly similar population to what we saw in the last night.
Okay. Okay. Okay. Thanks for that clarification, and one more thing I wanted to understand better is one of your data slides for D. P. M. You'll have a slide with chart with those on concomitant match and a separate chart, but those with advanced the piano doing for four more years.
But do you have a chart for data where the patients are both not on concomitant mat and with advanced TPN well what does that look like it's curious that they they have greater than two point improvement in N R S or something like that.
So we do have that stayed and.
We can look up the extra nonetheless.
<unk> on had a longer duration of disease for you the long ago.
And we have no lettuce on the concomitant medication has the strongest benefit and treatment effect when you compare it to active against placebo.
I mean that that.
That email I have sense, but.
Just curious if that data has ever been presented.
Yeah, we we have been looking it up as we speak so if we can find it either way we get fixed your throat do and I want to make sure that there's actually just I want to make sure I understand the question correctly you were looking for the.
The effects and the last study in V. P N among patients who were not uncommon in algetic medications and.
With advanced D P N greater than or equal to four years, because they don't have to leave our on our website and our in our public presentations.
And and they're sort of presented alongside the 127 patients out of 300, who had four years or greater Vance V. P. M. There's a subset also that we're not the one on the 27 patients are not on concomitant man. That's that's I don't know I'm, sorry, let me <unk>.
Let me clarify 127 patients.
We're only those who had greater than or equal to four years of a V. P N.
Subset of those patients were presented alongside it's about half of those patients 64 of those patients were also not uncommon in algetic medications and as you noted we saw a very profound reductions in pain over just four weeks in excess of two points on the N R S scale and.
Very significantly separating from placebo, albeit with a population in lower S.
Got it. Thank you so much and looking forward to the data mid to early next second quarter of 2002. Thank you.
Thank you.
Thank you Mr. Lee. The next question is from the line of Mark <unk> with S. C. D. You May proceed.
Hi. Thanks. This is my view on the line for Mike I, just have a couple of questions on 783 in the P. T. S. D Studies I think you mentioned in a prior call that you would be able to talk a little bit more about your strategies in terms of managing placebo rate is closer to initiation. So I was wondering if you could give us any.
Additional color there and then secondly, I'm, giving this may be one of the two registers no studies, what's the efficacy what can I get that and we can see should we be I'm thinking about and kind of like the bar there. Thanks.
Oh, that's terrific. Thank you again I think we can help you and your tickets also then maybe how 'bout kitten.
Supplemental complement accordingly.
Yeah sounds good I'll take the second part first I think we've said in the past and continued to believe that especially for a drug with good tolerability a separation from placebo in the mid single digits of say three to five a low to mid single digits.
Uhm is probably sufficient as long as it's statistically significant I think.
We've also talked about you know the change from baseline on the responder right being factors that questions really I think are more more focussed on.
Respect to placebo response mitigation, we go into a little more detail on that I think when we actually initiate and studies, but there's a few points. We can reiterate today I think one is obviously the study design our lives for a one to one randomization ratio between active and placebo.
Uhm, we've also I think taken some consideration and other study design variables to try to make sure that they are on the side of you know minimizing or mitigating placebo effect as we've looked at screening criteria as we'd like to duration of the study and things like that I think a T.
Part of the placebo mitigation will also include training both for subjects sites and also for writers and we can go into a little more detail on on what that involved I think as we disclose the full study design on some more of the details over the next few months.
Alright, Thank you yeah and.
Maybe just to add to that we actually took an early visit all the mall visit any day dream up with patients Uhm.
Uhm the higher as opposed to see what was <unk> also we reduce the number of your exposure to the P. T is the question now is I can say grading scale than days investigate are ready to cave in the previous trial you did both in this try if you just focus on to investigate that one was really hot so the exposure.
And I think they should there be going to pick on the placebo responses wood.
Okay.
Thank you Mr Goodman.
The next question is from the line of miles mentor with William player. You May proceed.
Hey, Thanks for taking the questions just on chewed on K five start off with.
On the evidence for a potential taking a response with 12 weeks of therapy in the face to face trial do you have any other evidence outside of the price for awake data that we're saying that doesn't seem to plateau. It still looks like it's on the efficacy enhancing trajectory.
<unk> and all sides of six weight data that I think was the best out of the preliminary fibromyalgia that I'm just trying to understand the 12 weeks of therapy how.
How much additional efficacy, we can sort of expect.
Yeah. So I think you already mentioned.
Mentioned some of all previous observations smiles and thanks for the question by the way.
In the earliest study we we didn't see like we typically do see a pretty rapid onset of activity or efficacy.
And in the 50 milligram dose that'd.
That'd be selected to be the dose of the curling phase two piece study.
We saw a very linear declined from week, one to be two two week to week for.
With a very clear indication that we would likely see additional improvements they asked.
<unk> typically in studies like this when you look.
Cause I see what begins to collect toys. So both of those should contribute to even better and stronger separation that there'll be able that you saw.
Sheesh mentioned a moment to go with that the results we had in.
<unk> advanced P. P N and the absence of Coca Cola didn't pain medication.
Cause they're very very dramatic reduction of two coins.
In the pinpoint waiting scale. So I I think that is the context that'd be fine to be really encouraging and supportive off.
The current study.
A couple of my other study that you mentioned likewise, how does effort onset.
While we did not see it in the lower dog.
It was readily observed in the 200 milligram dose.
Which was given about two weeks actually two weeks after the low ago.
And so the same applies yeah, and then that study.
He pointed out it was not ever.
It's daily painted what's what state he painted was problem as a questionnaire what <unk> all of those very strongly correlated.
With the 200 milligram dose being very efficacious.
<unk> like to actually point, Oh, it's because we are not relying on his finger and point, we look at multiple patients reported outcomes or in this study in addition to that Fabio Mark or is that all.
Actually clearly morphing of ice direction to support that this mechanism seems to be tricky part and install it in how it changes the brain physiology.
Okay, and then just to clarify question question on involvement number and the fries to be I think it's 329 participants listed on clinical trials Dot Gov.
If he can't tell me. The number you ended up <unk> can you tell me whether it's over on us.
If we can't tell you the number if he can't be told you. The number we have yourself. Please that's 229.
Sorry in one okay.
One for me is on four five is the preclinical work that you've done I think I've seen data on nonhuman primates with and pay tae paying sections that Dunkels motor dysfunction. Just wondering have you done that working out with some nuclear and transgenic months' because obviously patient stomach.
So sweet and pay <unk> apart from.
Yeah, that's a cute which is how we found out M. P tape I actually is about but I'm just wondering whether you've done any additional preclinical work there in an alternative models.
Yeah, I might've advise it or would actually be office of nuclear a nice model looked at it I think quite carefully.
After we'd already done the nonhuman primate M. P. T P work and I think there isn't really well characterized.
Weren't comfortable there was really a well characterized cognitive deficit and that model that it would be meaningful to kind of show that we addressed.
So so we haven't looked at that but I think we were not uncomfortable with the fact that the M. P. T. P model does not display.
Display severe motor deficits a lot of work went into the development of that model to try to replicate the cognitive effects I've ever seen in Parkinson's disease, and part of the protocol of administering MPTP chronically over a long period of time seems to create that deficit and it just.
Create a severe motor deficits at the same time it. So it's it it was a model actually we were very comfortable with him thought was translate to bowling on the bus model to look at.
Mhm.
It kind of makes sense, thanks placement questions.
Thank you Mr <unk>.
The next question is from the line of Gary Nachman Wood BMO capital markets May I proceed.
Hi, Thanks, Thanks for taking my questions. This is ever lost an uncle Gary Nachman.
My first question is regarding 7834 P. T. S. D. What are some theoretical safety concerns having a higher 150 milligram dose and can you remind us if there were any previous talks that he saw it and what was the highest dose evaluated their.
Yeah sure you know what.
Let me kick this off so of course, we know if homo preclinical Martha itself, which we employ quite a number.
That's the ghost off 50, that'd be already tests cause the those of 150.
Efficacious and and safe, which is important to mention.
We also have our phase one data, which is single and multiple attending does say the.
Which go much beyond so 150 milligrams of <unk>. So is our case, we're really fortunate to have consistently see in a very very favorable safety and tolerability profile.
While the other competent development might be Joyce limited.
Cause of safety auto liability concerns that is not the case in always studies with these compounds and so.
Eighth of the preclinical work, we have done and the phase one work.
We feel that the 150 milligram dose is another dose that is worth testing.
Because it should give us.
A better understanding of additional efficacy with out at all until I think the space of being concerned about safety also another ability.
Got it and then one more follow up for me for the 458 cognizant parent and and 292550 my ideal studies, how as enrollment and tracking so those studies given the increase in cost of his hospitalizations due to the delta.
<unk>.
And how many patients has been enrolled so far on those studies.
Alright, great.
Great Christian and I'm gonna have carefully and for that for Ya.
Yeah, we're tracking well and thus far private studying cognitive impairment and 2925 and fibromyalgia and.
And things are looking to be on track Friday to read out and then the second half of next year.
We certainly have been watching carefully the impact this COVID-19 across the trials that we continue expand track.
Great. Thanks.
Thank you Mr Nachman.
The next question is from the line of Chris Raymond with Piper stand There you May proceed.
Uhm. Good evening guys. This is Nicole Dobransky on progressed. Thanks for taking my question I guess just around fibromyalgia I know this is nit picking up that but it looks like timing for that ATB uhm data update and he's just been modified from first half 22 that can help may 22, I guess can you just provide any.
Clarity around this change in language I know the primary completion date on Quintiles Hussein Gean 2022, and it doesn't necessarily sound like you guys have any had any enrollment issues. So I'm just wondering maybe it could be thinking about canceling everything revolves around a medical conference. So uhm cause any clarity around now.
Great.
Okay. Thank you for the question.
Let me make one common might've just to correct myself I did not formally mention in my script. The 229 for the patient number.
Study, but it's on the government website of course.
And that's why I said, if we told you the number and then took more of a sense of the number is publicly available okay. Just fall collection.
On the question off in home and 458 and huddled males are you holding up then.
We are really pleased with that just like we have for the P. P N study.
As we have done for the D. P. Unstudied, we will provide better guidance or maybe even more definitive.
Definitive guidance as we completed enrollment but at this point, we think that the problem I I'll just study it's like to go to eat out in the first half at the end of the second quarter. It could spill over a little bit we will see but we have a better understanding of that as we completed.
And for the 458 study in Parkinson's and Louie budget adventure that is still unclear cough cause you mentioned for second half of 2022 was supported by via the one the numbers we have and so there's no reason to actually change those timelines typically communicated before.
Okay Uhm that's.
Very helpful. And then maybe just a quick second question on 783, just around managing enrollment between study wanting to I I know that the study start or.
Staggered, but I guess is there any concern that enrollment in 31 can take longer than expected patients or doctor kind of holding out.
To enroll patients with the higher 150 milligrams down Uhm for study too I guess have you heard any kind of feedback on that.
Yeah, but it wasn't too.
Kathleen can give you the answer to that.
Yeah, our strategy there is to actually put a different studies at different investigator site.
So.
Where the patient geographically lamps, or where they're comfortable going to the clinic. They will not have the option of all studies that'll be enrolled in the study that that clinic is running.
We think that that reduces I S. And also gives us a representative sample across a study which is important as we advance that development program.
Alright, that's very helpful. Thank you.
Thank you Mr. Amen.
The next question is from the line of Ron Silver.
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With H C Wainwright 315.
Hi. This is my lungs are thanks for the update Uhm what are the programs progressing very well cohesively in terms of initiations enrollments and Readouts just to shift gears.
Are you able to share any impactful progress in your discovery pipeline and you need to reset the systems biology target indications that you're excited about and that you wish to reveal.
Yeah, that's a great question and I think it gets too little attention typically when the report so.
So maybe just as a reminder to audience here, we have been synthesizing these positive allosteric modulators for quite some time.
We have designed and synthesize that impulse like more than 1200 of them and of course I'll just that point of view. It then spell instead of killing me in the clinic.
We have a number of components ready.
To be further advanced into I N D. At the right time and that gives US a review which portfolio off compounds to choose Paul May I ask where you can see the pogroms further.
That's that's the latest on the preclinical part.
And of course.
Discussed before.
Part of what the.
Investigate this all compounds is wait until they have to do that bind.
They buy into a novel binding domain within that domain. That's type 2441 component to the next but it's a new previously not describes domain with a complaint is fine we can characterize that pharmacologically. We can also characterize it quite nicely.
With all molecular biology toilets, whereas singer point mutation in that's binding domain or finding site and completely abolish the effect of the compound and.
And so we have quite an extensive like totally off preclinical data that support the pharmacology until we set built engagement off the components.
Perhaps there is an opportunity for us to present that a little more broadly at some point because I do believe it's does make us the leader in the space of positive atmosphere like modulators exiting on <unk> on the NMDA receptor.
Alright fantastic. Thank you know the.
Yep you're welcome.
Thank you Mr sounds our eyes you.
The next question is a follow up question in the mind of miles Minter with William Black You May proceed.
Hey, Yeah, sorry, no, but [laughter] 998 to apologise my questions actually go a shake you've got a debt facility in place and also an active Ikea M. A way expecting that you're just going to go down by today's continuously you got it.
Right for a data right out and sort of how do you think about utilizing quotes of stories facilities, making pulled to to find the pop ups. Thanks.
Yeah. Thanks for the question miles I think that we've always been attentive to the balance sheet and and we will of course continue to be but we're we're pleased to be in a position with a strong balance sheet that's funds.
Multiple phase two data readouts actually across each and every.
Clinical program at our pipeline and Fibromyalgia N D. P. N P. T. S. D and then cognitive impairment that gives us a really nice flexibility both with regard to cash and the access to capital. Both ahead of the data, but also you know through the data I don't think we're in any Russia need to.
Think about incremental financing.
Appropriately to think about a balance you enhancement I think appropriate times and then especially in support of the next steps on developments, but we're in a good position right now.
Okay cool thanks.
Thank you Mister Minton.
I am showing no further questions at this time I would like to turn the call back over getting a leather any closing comments.
Uh-huh.
Thank you all and thank you all for your Christians.
We appreciate your time and your attention.
Please be well and enjoy the rest of your day Bye bye.
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