Q2 2022 Aptinyx Inc Earnings Call
Further developed NY X 458 across other cognizant of impairment condition.
We look forward to sharing more updates in the coming months as the study moves toward completion ahead of the expected readout in Q1 2023.
Finally, let's move on to NYSE 73.
And we have 73 is currently being evaluated in a phase <unk> study in patients with posttraumatic stress disorder.
Eddie which kicked off towards the end of last year is evaluating 50 milligrams of NYSE 780, <unk> Judy versus placebo in approximately 300 PTSD patients over 10 weeks of treatment.
As a reminder, our similar study looking at 150 milligrams QD was placed on a temporary pause prior to the start of its enrollment in order to extend our cash runway following our GPS data readout in April we remain committed to Recommencing. This study is operationally and financially feasible to do so.
Following the initiation of the phase <unk> study for the 50 milligram dose in November our team has worked diligently to bring the study sites online and begin enrolling patients. Despite.
Despite an increase in clinical development activity in PTSD across the industry, which is increased competition for sites and patients we've seen steady progress over the past few months and we remain on track to report data from this study in the second half of 2023.
In addition, as I mentioned at the beginning of the call. We're very excited that the FDA recently cleared our IND application to allow for the evaluation of <unk> 73 in patients with opioid use disorder or <unk>.
This <unk> is a testament to the productive partnership <unk> enjoyed with a world class team of researchers at Yale University School of Medicine spearheaded an impressive preclinical development efforts building on our work in extinction learning in PTSD and alcohol use disorder.
<unk> team has generated compelling preclinical data supporting the hypothesis that the extinction learning mechanism underlying <unk> 73 may provide a safe and effective treatment for OLED.
And there are studies NYSE 73 showed positive effects combined with a strong safety profile and models of addiction utilizing oxycodone.
The preclinical data that was generated with the support of a multimillion dollar dropped under the NIH is helping to end addiction long term or heal initiative.
Based on the preclinical evidence our researchers research collaborators at Yale recently received preliminary approval by the NIH and Nader to transition to a clinical stage development, starting with a phase one study of NY at 780, <unk> and people who use opioids to begin later this year.
Opioid use disorder represents a significant public health issue facing society today in this phase one study and <unk> will be a critical first step to evaluating NY at 73 potential for treatment.
We look forward to sharing more detailed updates on this program later in the year as the clinical stage Grant funding is formally announce on the phase one study is initiated.
I'll now hand over to Ashish to review our quarterly financials.
Thanks, Andy.
Beginning with the balance sheet. We ended the second quarter of 2022 with $85 $3 million in cash and cash equivalents compared to $106 1 million at the end of 2021.
We expect this existing cash balance will support operating runway into 2024 and kind of enabled data readouts from each of our ongoing clinical development programs.
As Andy mentioned earlier, we also do not anticipate the upcoming phase one study of <unk> hundred 83, and <unk> to impact our cash burn as the clinical study will be conducted by the team at Yale and funded by the generous grant from Nida.
The majority of our spend during the quarter centered around research and development related to our ongoing clinical studies.
R&D expenses were $11 9 million for the second quarter of 2022 compared to $14 8 million for the same period in 2021.
The decrease in R&D expenses was primarily driven by the completion of enrollment in our phase <unk> studies of NY accident, two five and both DPM and fibromyalgia.
We reported G&A expenses of $5 2 million for the second quarter of 2022 compared to $5 1 million for the same period in 2000.
Finally, our net loss for the second quarter of 2022 was $17 7 million.
Compared to a net loss of $19 8 million for the same period in 2021.
I'll now turn the call back over to Andy.
Thanks Ashish.
We're very happy with our progress in the last quarter. Despite the disappointment of VPN. Our team has shown incredible dedication to bring each of our clinical studies closer to the finish line and we're poised for two major phase II readouts in the very near future supported by a strong balance sheet.
We are happy to begin taking your questions.
Thank you and as a reminder, at this time if you do have a question that will be star one.
Well move first today to Marc Goodman with SB Securities.
Hi, Thanks for taking my question Judy online for Mark.
So for the upcoming fibromyalgia data can you remind us.
What are your current expectations for the baseline pain score and the change from baseline proposed.
On line 292 client placebo. Thanks.
Yes. Thank you.
Yeah.
So I think it's difficult to be too specific as we know from the variation that we see in different pain study.
I think I've talked prior to VPN, one thing to see baseline pain scores that were at least in the mid single digits and I think in our VPN study they were a little over six.
And so I think our expectations and fiber are similar.
And then again with respect to changes from baseline.
Those do vary from study to study an indication to indication.
I think the most important point is the one that we mentioned in the remarks, which is.
In order to be clinically meaningful and it does depend a little bit on other factors like safety and Tolerability of obviously the variation seen.
But as we mentioned.
Thing to see a separation between.
<unk> hundred 95, and placebo of Iraq five points are higher on the IRS.
Got it.
Regarding borrowing.
You mentioned youre going to have it on the phase two meeting with the FDA, but can you provide more granular timing.
Starting another trial by the end of year into next year.
Yes. Good question I think starting the next trial would be into next year.
Our expectations for the timing of the meeting with FDA, we will move as quickly as we can but it depends a little bit on the timing from the agency side and I think that we're certainly not expecting to start. The next study this year that would be into 2023.
Got it.
Thank you.
Thank you.
Okay.
Carl.
Good afternoon, guys can you hear me okay.
Yes, okay.
Thanks for thanks for taking the question wanted to ask about.
How standard deviation or variance for pain scores in fibromyalgia and might differ from VPN.
Wondering about assumptions.
<unk> bounce.
What expected placebo response might be for this indication versus CPM as well.
Yes, thanks for taking it.
Good question as you probably know there've been a range of studies done in these indications and there is a good amount of variation.
From study to study.
One of the things that I can say is we do in this study as in the last one we do apply some screening to the patients beforehand in terms of their payment for reporting.
And then we also training patients in terms of accurate pain score reporting once they are in the study.
So we have done a few things that we.
We try to minimize the variance of the pain scores.
There is I don't think consistent evidence that thats markedly different between fibromyalgia VPN and other pain indications, but we have taken similar steps.
Try to manage it.
And then I think it's a similar story with placebo response.
There is some evidence from meta analyses that have been done and published that might suggest.
Some cases FIFO studies have seen a little bit of a lower placebo effect, but I think importantly.
We're not.
Putting too much weight on that but that is something that has been published.
Got it Thats helpful and can you talk a little bit about 73.
And.
Enrollment thats coming.
Yes, I think as I said.
It's certainly we certainly see.
Some increase in industry activity overall in PTSD and as I mentioned that have led to more competition for site for subjects, but I think that we've managed to work through a lot of that over the last few months and so I think our feeling now is that.
You never know what will happen in the future with factor that drive enrollment but.
But I think like I said right now we feel reasonably comfortable.
With the timelines for the study, but it certainly I think the process.
Identifying and activating sites.
<unk> has been definitely affected by the fact that there is a lot of industry activity going on and I think we've heard that.
We've heard that from quite a few people like I say I think we're comfortable with where we are not.
Got it great. Thanks for taking the questions.
Yes.
We will go next to Julie with terrific Securities.
Good afternoon. This is awesome on for Julien Thanks for taking the questions.
So now that these <unk> results for D. Peter known how do you think that might influence placebo response in the upcoming at that trial.
And my second question is if you could comment on the impact of the NIH funding on your plans for 73 and anticipate further grant. Thank you.
Yes. Thank you. Good question, so I think for DPM, we wouldn't imagine there'd be much in Poland.
In terms of the timing we had already completed enrollment in the fibromyalgia study by the time the VPN data were made public.
Yes, it would only have been a very small number of patients that were still kind of in treatment and a lot of them would be quite part through so I don't think there is there is likely to be much influence there.
With respect to 703 in NIH funding I think we will be able to talk a little bit more about that one.
As I mentioned, it's formally announced.
But I do think.
There is a path for funding.
The phase one study and potentially some next steps beyond that I think we look on this is really a good way for us, particularly at this time now where we're trying to maximize our cash runway to really create a whole new program and I think in a disorder, whereas I mentioned, there is substantial unmet need and I think on top of that to be working with the research.
<unk> at Yale University School of Medicine.
Tremendous experience and.
Great background.
Study in opioid use disorder, which as you can imagine there are some complexities to studying.
Very excited about that so yes, I think it is.
It's the phase one study and potentially as well some.
Some next steps after that.
Thank you and congrats on the progress.
Keith.
Yeah.
We'll hear next from Garik <unk> with BMO capital markets.
Hi, This is evan on for Gary Nachman.
For taking our questions yeah.
My first question for NYSE.
Three.
Some of them an exclusion criteria in the trial, but could help manage the potential variance in the patient population.
And then secondly for Tonight.
Can you just talk about your confidence level to be able to hit the.
Primary and secondary endpoints in the fibromyalgia study.
<unk>.
Thank you.
Well so for 73 in terms of exclusion criteria variance.
<unk>.
I think in general terms there is.
As there was in the last study obviously, we're looking for.
A certain extent of symptom severity.
So trying to exclude particularly the patients with milder symptoms that are closer to a floor effect.
There is a few other things that we have put in there, but I would say for the most part we have also tried to make sure that this is a representative patient population, which is quite important in this case, because it really isn't a strong biological basis or segue.
Segmenting that population.
And so we have a range of different types of trauma and so on I think we've also mentioned one of the things that we notice.
The last study that we published for us to do within.
In association with time since trauma, and so that is something that we are.
We are very mindful off we're not excluding patients with a longer time since trauma.
But we are.
We are taking steps to make sure that we have a good balance of patients sort of a shorter tax since trauma.
As well so yes, there is a few things, but I think.
A lot of the variance actually comes not so much from exclusion criteria all of that plays a role.
What we're focused on the areas of quality of the data that is collected by the sites.
As you May recall the primary endpoint is the caps five sales for the clinician assessment of PTSD symptoms aligns with the DSM five and so we're putting a lot of effort into making sure that.
That we have a relatively.
Limited number of sites with very well trained raters unlimited numbers of <unk>.
But particularly to do with the training and the quality of the data.
And that survey surveillance of that so I think a lot of it really is more there is making sure that.
This is a business of scale, where we want to make sure that the quality of data that we get from meadows as high as possible and therefore any variance has to do with two underlying differences and sometimes not differences in rates, Arizona methodology and so on.
With respect to the second question.
Like I said I think we're optimistic about the study.
There is.
What a difference of biologically between VPN in fiber I think fiber myalgia classified as domestic plastic pain condition.
<unk> pain stage, we know that <unk> is a peripheral neuropathy.
All of this of course has been aware of those differences.
But I think also as I mentioned this builds on the neuro imaging study that we published.
Yes.
Disclose the data from in 2019.
This showed year imaging biomarkers.
Improved in fibromyalgia with <unk> 95, and in that study. We also saw some improvements in some of the other symptoms like fatigue and so on so I think we're always cautious ahead of the readout, but I do think.
As we usually are we are cautiously optimistic because of those differences.
Some of the underlying data that is building up.
Great. Thanks.
And as a reminder, if you do have a question.
At this time, we will hear now from Myles Minter with William Blair.
Hi, Thanks for the questions.
On the Fibromyalgia study can you just remind us of the staff hierarchy. Here are you testing the 100 milligram dose versus placebo before the 50 Meg.
Versus placebo and on that 100 milligram can you remind us how that actually performed in the neuro imaging study relative to.
The milligram dose.
<unk> on the doses that you tested in that product study site.
I apologize for the <unk>.
No problem. Thank you.
So in terms of the hierarchy I think we've mentioned before that one of the aspects of the study that is more exploratory and in many ways.
Very robust.
Pivotal design study, but one of the more exploratory aspects was the dosing and so we are not testing the doses hierarchically real.
And both independently.
And in the prior study that you referred to we tested two doses 20 milligrams and 200 milligrams and we saw biomarker effects of both doses and what appeared to be a stronger clinical effect with the 200 milligram dose although that interpretation was complicated by the fact that they were administered sequentially.
So by the time the patient to finish two weeks 200 milligram they've been on drug for four weeks versus with the 20 milligram they've been on drug for two weeks and so.
We worked with our collaborators on interpreting the data and we felt as though.
Testing two doses in the Middle 50 milligrams 100 milligrams was the best approach.
And so that because neither of those two doses was faster than your imaging study, but doses either side of that showed effects on the neuro imaging markers.
Okay. Thanks for that and then just on the sideline study that Spain is by your friends at Yale there.
I guess one of the goals of that study and why is it a phase one study when theoretically you have already done that specific 93, so you're kind of neither safety is that are we going to get some sort of.
Dose selection out of that study that in future Grant funding.
<unk> trial, I guess, what are your outcomes coming out of that thanks.
Yeah. Thanks Myles.
I'm going to answer that question, yes, thanks, Andy.
It is a different phase one trials in the single ascending and multiple ascending dose that we've already done with 73. This is a direct drug drug interaction with oxy cardon looking at safety Tolerability and PK, if that's two compounds together.
Do you have any.
Direct head to head data in preclinical models against naloxone.
So the comps up against that.
Well, it's a different mechanism of action.
They are different conceptually a different thing that naloxone, obviously, which is sort of block.
Blocking the effect this obscured with extinction learning.
And.
Essentially making the process of stuffing taking opiates.
Okay.
Here quicker.
Quicker with fewer drug seeking symptoms I think one thing I will say on this Myles is and we were a little bit higher level in our remarks.
But we do anticipate that this.
Data will likely be made public.
And by the <unk> team over the next few months. So I think we're holding off a little bit on going into too much detail here, but thats certainly data that you will likely see over the next few months shown in more detail.
Okay cool thanks, thanks for the questions.
Thanks, Bob.
Okay.
Well hear now from Charles Duncan with Cantor Fitzgerald.
Yeah.
Charles.
Okay.
Mr. Doug maybe you might have us on mute.
Yes.
Okay.
Sorry.
Bush to join the queue at a later time.
Thank you, we'll move next to Rob <unk> with HC Wainwright.
Hi, This is Bob Allen dialing in for Rumson Rod you can you hear me okay.
Yes.
Great couple of questions from US Firstly are you planning to evaluate any chronic pain indications in the future or is that not going to be part of the strategy moving forward.
And so fibromyalgia.
Being a chronic pain condition will drive that I think at this point, we mentioned we weren't planning to move forward with VPN. So yes, I think clearly if we have positive data, we will move into phase III with fibromyalgia and I think we will also review at that point in time.
What other based on the data what other chronic pain indications, we think it might make sense to explore in addition, so I think there's a little bit to be determined by the data, but yes that would still be our plan.
Great. Thanks, and then within the Parkinson's disease program.
What would you consider a clinical success and how do you see foresee THB helping position.
Yes.
A question and this study is characterizing the effect on cognitive impairment and as I mentioned, we're doing that with a series of them.
Well validated tablet based in Euro collection device.
They cover retention working memory and executive function is very hard.
Find I should say is this is only one drug rivastigmine that's approved for Parkinson's dementia, and nothing approved for Parkinson's mild cognitive impairment.
Rivastigmine was approved over 20 years ago with the primary endpoint being an alzheimer scale.
So I think one could argue the unmet need is pretty significant.
It's not specific to one cognate remain or another.
There's really a lot of issues, there's different patients can experience based on different.
A different pattern of cognitive symptoms or different effects and different cognitive symptoms. So it's not really I think at this point meaningful to say, we need to see a very specific thing in those six neurocognitive test clearly we need to see something that is commensurate with an active drug that we think can be clinically meaningful but I think it's very hard ahead of.
Time to describe exactly all of the different permutations of that could be we would need to see a meaningful improvement in cognition and we've got those six different scales across the different domains to do it I think in the past what we've said is more if we see something that we think represents.
Coherence signature of a signal across the endpoints and theres, probably multiple options as to what that would be combined with good safety and tolerability, but that would then theres multiple permutations of that but that would be a basis for moving forward.
Great. Thanks for the detailed answer.
That's it from us thank you.
Great. Thank you.
And once again for questions that is star one at this time.
And with no other questions at this time, Andy I'd like to turn things back to you for closing remarks.
Thank you operator, and thank you for all the questions. We appreciate your time and attention and wish you all a very pleasant rest of your day.
And that does conclude today's conference again, we thank you all for your participation and you may now disconnect.
Okay.
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Okay.
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