Aptinyx Inc. (APTX) Q1 2021 Earnings Call Transcript

Aptinyx Inc. (APTX)
Q1 2021 Earnings Call
May 13, 2021, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, and welcome to the Aptinyx first-quarter 2021 financial results conference call. [Operator instructions]. At this time, I would like to turn the call over to Nick Smith, vice president, corporate development, and investor relations at Aptinyx. Nick, please proceed.

Nick Smith -- Vice President, Corporate development, and Investor Relations

Thank you, Operator. Good afternoon, everyone, and thank you for joining us on today's conference call to discuss Aptinyx's first-quarter 2021 financial and operating results. Our press release describing financial results and business highlights is now available on our website. Today on our call, Norbert Riedel, our chief executive officer, will review our business and clinical progress; followed by Ashish Khanna, our chief financial officer and chief business officer, who will review the financial results.

In addition, Andy Kidd, our president and chief operating officer; and Kathryn King, our senior vice president of Clinical Development; and Harald Murck, our vice president of Medical and Pharmacovigilance are with us for the Q&A portion of the call. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Any forward-looking statements are made only as of today, and we disclaim any obligation to update these forward-looking statements. Please see the forward-looking statements disclaimer in the release of our financial results issued this afternoon and the risk factors in the company's current and subsequent filings with the SEC.

Norbert, over to you.

Norbert Riedel -- Chief Executive Officer

Thank you, Nick, and good afternoon, everyone. We appreciate you taking the time to join us on today's call. Before we delve into our clinical programs, I would like to share with you that we have recently announced the appointment of Dr. John Miller to our board of directors.

John brings extensive experience in academic and medical leadership, clinical development, and clinical research to our board, and we are excited to have her join us as we progress into later-stage clinical development. Related to our clinical programs. Although it has only been a few weeks since our last business update call, we have made important progress across each of our four programs. As you recall, we currently have three Phase 2 clinical studies under way one in painful DPN, one in fibromyalgia, and one in cognitive impairment.

Our teams have been executing diligently on patient enrollment in this study, and I'm happy to report that each of these studies is tracking very well. We're also have been keenly focused on moving our PTSD program toward the initiation of a Phase 2b study with the design intended to be registration supportive in this indication. These past few weeks, in particular, have come with a number of positive developments for our PTSD program. So I will start with those updates for NYX-783.

In late April, we presented additional data from our initial exploratory PTSD study at the annual meeting of the Society Of Biological Psychiatry or SOBP. These data provide insights from Stage 1 of the study, which was a four-week treatment period have included all patients in a double-blind, randomized, parallel design, most consistent with and informative of our next study. We reported that a significantly greater proportion of patients achieved a clinically reliable change in the 50-milligram treatment group, compared to placebo. The reliable change index is defined as an improvement of 13 points or more on the CAPS-5 Total score and is a recognized metric for determining real effect as opposed to effect driven purely by variability.

Our SOBP presentation also highlighted that when accounting for baseline imbalances across groups in the patient's time since trauma, the percentage improvement on the CAPS-5 Total score for the NYX-738 50-milligram group separated from placebo by a statistically significant margin. These additional analyses reinforce our confidence in the therapeutic potential of NYX-783 in the treatment of PTSD. Also in late April, we met with the FDA for a Type C meeting to discuss the future development path in PTSD and to review the key design parameters of our planned Phase 2b study. It was a positive meeting, during which the agency provided us with valuable input on a variety of study parameters.

And we are in the process of finalizing the details of the protocol for the upcoming study accordingly. As we have laid out at a high level in our public presentations to date, this study will involve the evaluation of 8 weeks to 12 weeks of daily dosing of NYX-783 compared to placebo in a randomized parallel design with the CAPS-5. Total score as the primary endpoint. We will be proceeding with that design and accordingly, if the data are positive, we believe the study has the potential for consideration by the agency as one of the two well-controlled studies required in support of an NDA.

Of course, that will be MFFO review by the agencies following the completion of the study and review of the data. We plan to provide greater details on the study design and continue to anticipate that we will commence this Phase 2b study in the second half of this year. Let's briefly discuss NYX-2925 which is in Phase 2 clinical development across two chronic pain indications in painful diabetic peripheral neuropathy and in fibromyalgia. I am glad to report that we have made excellent progress in both studies and we continue to be on track toward our enrollment goals and our projected data readouts in the first half of 2022.We appreciate the continued engagement from the investigator sites and patients involved in this study.

Let's move now to NYX-458, our product candidate in developing for the treatment of cognitive impairment. We recently announced that we have we commenced an exploratory Phase 2 study in patients with cognitive impairment associated with Parkinson's disease and with dementia with Lewy bodies. This is the first time NYX-458 is being evaluated in patients with these diseases. This exploratory study is designed to detect a signal of therapeutically relevant activity of NYX-458 and to assess its tolerability profile in this patient population.

This is a double-blind, randomized parallel design study and is expected to enroll approximately 100 patients to receive daily dosing of either 30 milligrams of NYX-458 or placebo over a 12-week treatment period. Given the level mechanism of NYX-458, we are evaluating multiple cognitive endpoints in this study in order to characterize the activity across attention, memory, and executive function. I am pleased with our progress so far and we expect to be able to report data from this study in the second half of 2022. With that, I will now turn the call over to Ashish to review our first-quarter financial results.

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

Thanks, Norbert. As we make progress across each of our programs, we are fortunate to be supported by a strong cash position. We anticipate our current cash will fund our operations into the year 2023 enabling readouts from multiple Phase 2 clinical studies along the way in 2022. Specifically, beginning with the balance sheet, we ended the first quarter with $146.8 million in cash and cash equivalents compared to $141 million at the end of 2020.

Revenues for the first quarter were $1 million compared to $0.8 million for the same period in 2020. These revenues were related to our research collaboration agreements with Allergan, now a subsidiary of AbbVie. The collaboration agreement has come to its predetermined contractual conclusion. And accordingly, we expect no future revenues associated with it.

The majority of our spending was focused on research and development related to our ongoing clinical studies across chronic pain and cognitive impairment. R&D expenses were $10.3 million for the first quarter compared to $11.5 million in the same period in 2020. We expect R&D expenses to increase throughout 2021 on account of our three ongoing clinical studies, as well as our planned Phase 2b study of NYX-783 in PTSD. We reported G&A expenses of $5 million for the first quarter, compared to $4.9 million for the same period in 2020.

Finally, our net loss for the first quarter was $14.2 million compared to a net loss of $14.7 million for the same period in 2020. I'll now turn the call back over to Norbert.

Norbert Riedel -- Chief Executive Officer

Thank you, Ashish. This is an exciting period of time for Aptinyx. With our three ongoing studies progressing very well and with another PTSD study to be initiated in the coming month, this year is next will be critically important for us as we seek to clean better therapeutic options to patients in need. We feel confident that our focus on execution across our clinical programs along with our strong financial position will enable us to achieve multiple potentially catalytic milestones within the next 12 to 18 months.

We will be happy to begin taking your questions now. As we feel the questions, I'd like you to keep in mind that we will be limited in how much we can talk about our next PTSD study, as we are still awaiting the minutes of the meeting. With that said, I open it up for Q&A now.

Questions & Answers:

Operator

Thank you, sir. [Operator Instructions]. Our first question comes from the line of Myles Minter from William Blair. Your line is open.

Myles Minter -- William Blair -- Analyst

Hi, thanks for taking the questions, and congrats on the FDA meeting. My first one is just on the SOBP data and the correlation that you saw between enhanced efficacy with the 50-milligram dosing patients that had a more recent traumatic event setting off their PTSD. I guess given you have those learnings now, how are you thinking about incorporating those into the child design? Would that be something in the inclusion, exclusion criteria for that child or would it be something more like a pre-specified analysis where you might want to stratify those patients when you have the data set?

Norbert Riedel -- Chief Executive Officer

Thank you, Myles. That's a terrific question. I'm going to have Andy kick it off by giving you a sense of how we are thinking about that at this point.

Andy Kidd -- President and Chief Operating Officer

Yes thanks, Myles. Good question. As Norbert said, we can't be definitive about this. I think one thing we would say on this specific question though, is our preference would probably be to avoid entirely excluding patients with a longer time since trauma and we probably looking to other ways to incorporate that learning, but we can be more specific once we finalize the study design.

I think that's the only point we want to make right now.

Myles Minter -- William Blair -- Analyst

Ok, fair enough. And then we've been talking to a few clinicians, I think a clinically meaningful improvement on the total CAPS-5 is 10 points from baseline with a treatment, you definitely saw that in the age trial, but they also made a comment on 4 points over placebo, I guess, does that jive with what you would anticipate being clinically meaningful over placebo and I guess the obvious question would be, you expect to obtain that going from four weeks of therapy to 8 weeks to 12 weeks like you're stipulating?

Norbert Riedel -- Chief Executive Officer

Yes, I think that's roughly right Myles, I think we would expect to see, perhaps continued improvement over the course of four weeks to eight weeks, as well as a few other factors. I think again, which we can get into more in the detailed study design that might help us out, as well as obviously the study being larger. So yes, I think that's fair.

Myles Minter -- William Blair -- Analyst

But just to be definitive, you'd agree that a 4 point move over placebo would be the clinically meaningful threshold here?

Norbert Riedel -- Chief Executive Officer

I think it's in the right direction, but I don't think we'd be pinned down to that exact number. Again, as we design the study, we'll think about specific effect sizes that we're looking to see and that we're powered to show, and so forth. Again, we probably can be more specific down the line.

Myles Minter -- William Blair -- Analyst

And my final question is congratulations on John Miller on the board. That's a great appointment. She obviously has extensive expertise in ophthalmology. So this is a broader question, but it does bake the question of whether you're going to potentially look at expanding the NMDA modulator platform into ocular indications? Is that something you're thinking about or am I completely on the wrong out of the ballpark on this one?

Norbert Riedel -- Chief Executive Officer

No. So I think Myles, really our excitement about John joining the board is fairly extensive academic and medical leadership experience that we pointed out in the press release as well as her involvement in clinical development and clinical research all the way to basically having been instrumental in getting the first therapy approved for AMD. So that is terrific. I think as we have communicated before that there are numerous other areas in which NMDA receptor biology is developing and shown to be involved in various diseases beyond what we currently have on our plate.

But for now, we will stay the course with indications we are in and see where we go from there. And when the time comes to basically extend our scope, I look forward to John being a key contributor to actually help us test what makes the most sense and how to go about it.

Operator

[Operator instructions] Our next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yeah, thank you, Norbert and team. Congrats on the progress in the quarter. I did have a question, I wanted to follow up on the PTSD program 783. I guess I'm wondering, you mentioned having a positive Type C meeting.

Can you provide any color, I know that you're waiting for the meeting minutes, but any key takeaways that you consider positive, was it positive with regard to the agency's awareness of the challenge of PTSD or the mechanism of 783 that could be differentiated or some design feature that you want to point to? And then I did want to ask you recently the NMDA trial has been read out and I'm wondering if there are any new thoughts that you have on PTSD and the opportunity there given the NMDA results? Thanks.

Norbert Riedel -- Chief Executive Officer

So terrific, thank you, Charles. So look the Type C meeting was very positive in that I think there is a clear acknowledgment and recognition that PTSD is a significant challenge we have for which there are very limited frequent choices. And I think that is in support of new mechanisms and new approaches to finding ways to actually serve sufferers from PTSD much better. I think it was also positive in that what we had communicated before as the outline of our study is indeed, roughly how we will go about it.

And as we pointed out, there will be details and news to that that we will communicate at the right time. But I am pleased that what we outlined and communicated before is very much in line with what that Phase 2b study is going to look like. On the MDMA results, I think that's actually very, very encouraging for a number of reasons. First, and most importantly, it looks as if it fully makes a very meaningful difference to patients who have actually been treated with MDMA compared to placebo and CBT.

And what I like about it is that our definition of what the mechanisms are that need to be active here in the treatment of PTSD is fully is about plasticity changes, it's basically, I would say, includes terms a reset of the cognitive network. And I believe that our mechanism of MDMA receptors and plasticity enhancement works along those lines, as we have shown, and I very much liked that mechanism, and the superb safety profile and tolerability profile that comes along with that that we have now established with three of our compounds in pretty large numbers of either healthy volunteers or patients. So I think that differentiates us and that's why we are really excited about where we go about and how we go about PTSD and other indications.

Charles Duncan -- Cantor Fitzgerald -- Analyst

I was hoping you'd make that mechanistic connection, and I appreciate you taking my multi-part but single question. Thanks, Norbert.

Norbert Riedel -- Chief Executive Officer

If you have another one, I will let you take it in now.

Charles Duncan -- Cantor Fitzgerald -- Analyst

I have many, but I want to be respectful of the other people on the call.

Norbert Riedel -- Chief Executive Officer

All right. Maybe when we have time in the end you get back in the queue.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes.

Norbert Riedel -- Chief Executive Officer

Thank you.

Operator

Our next question comes from the line of Joon Lee from Truist Securities. Your line is open.

Unknown speaker -- Truist Securities -- Analyst

Hello, [Inaudible] on for Joon. Thank you for taking our questions. And regarding the Phase 2b trial for 783 in PTSD, what proportion of civilian and military PTSD patients will be enrolling if you could give us some color on that? And how do you think these relate to moderate versus severe PTSD baseline? And then the extract that simulates to 295, where we saw a bigger effect on advanced DPN patients, there will be a larger benefit of 783 also in patients suffering from severe PTSD or having PTSD for a longer period?

Norbert Riedel -- Chief Executive Officer

Ok, let's see how we can tackle this as a team. So I'm going to get to your part of the question that relates to the DPN study and patients with more established longer duration of disease. I just made the comment to Charles that we are looking at this from a point of view of plasticity changes. And in DPN of course the disease the neuropathy starts in the periphery.

But over time it manifests itself centrally and does cause changes in how pain is actually perceived importance. So mechanistically, it makes perfect sense that advanced patients who have suffered from the disease for a long time have a more pronounced manifestation of the pain perception and processing issues in their brain, which is why we actually rely on the earliest study we have done by saying mechanistically it makes sense to have the covenant Phase 2b study be focused on patients that have had a longer duration of disease. I think that answers your DPN question. Let me have Andy give a try to the PTSD study, but as I said already, as it relates to patient numbers size of files, and parameters such we will not and cannot comment on that until we actually are first of all, in the position of the minutes of the meeting and have further designed and finalized our study design.

Andy Kidd -- President and Chief Operating Officer

Yes, thanks, Norbert. I think the one thing we can reiterate because we did make the point that the study design we had outlined to you in prior calls and so forth, is still the direction that we are heading that we still as we said before a plan to enroll in a fairly broad PTSD population and our general philosophy would be to try to include as representative of a patient population as possible of the entire PTSD patient group. But beyond that I think at this point we can't comment more obviously, there will be some specific inclusion-exclusion criteria we will apply. And I think we can comment more on those once we finalize the study design.

Unknown speaker -- Truist Securities -- Analyst

Thank you. And very quickly -- where should the benefit on this acute injury NHP model of Parkinson's? How do you think this would translate to a disease setting where you expect less NMDA receptor expression?

Norbert Riedel -- Chief Executive Officer

Ok. If I guess I understand your question, right? You're asking a mechanistic question as to how 458 goes about in our actual view of the data, there are few potential therapeutic benefits in cognitive impairment. And I'm going to have Harald actually address that question. Harald If you wouldn't mind, following up, please.

Harald Murck -- Vice President of Medical and Pharmacovigilance

Yes, of course, one of the observations which led us first and foremost to basically combine the indication of Parkinson's disease dementia, dementia with Lewy bodies that they have similar pathophysiology, which is based on an increase in α-synuclein which really the basis of both of these disorders. And it is known from preclinical studies that α-synuclein leads to down regulation of NMDA receptors as has been demonstrated in a number of animal models, we have our own data on the effect of NYX-458, we actually see that there's a compound that up-regulates an NMDA receptor. So in a very mechanistic way, we have been working hypothesis to say that we are basically reversing the strong regulation which is induced by α-synuclein and expect to see the beneficial clinical effects by this, but if you want to, of the pathology. As a scientist, the working hypothesis is based on animal data.

But I think this is as strong as it gets in this space of science.

Operator

Our next question comes from the line of Laura Chico from Wedbush Securities. Your line is open.

Laura Chico -- Wedbush Securities -- Analyst

Good afternoon, and thanks for taking the question. I will try to focus it on just one. And I definitely like to ask one on 295 and the fibromyalgia study. So there was a recently published study on fibromyalgia that examine whether sensitivity transitive relationship to NRS scores.

So it was interesting that nearly two-thirds of the subjects were deemed to be sensitive to weather and ended up having worse NRS scores. And just looking at the geography for the Phase 2 study for 295, we've got a pretty diverse sampling here across different U.S. regions. And just wondering if you could talk to maybe your thoughts on how you might be controlling for that variable in the study, but also b just remind us about any powering assumptions on the primary endpoint? Thanks very much.

Norbert Riedel -- Chief Executive Officer

Great. Thanks, Laura. Kathryn, would you like to take that question and share your thoughts?

Kathryn King -- Senior Vice President -- Clinical Development

Yeah, I think as you noticed, we've got a diverse and wide geographic spread of our sites. So I think with respect to that impact, we certainly could look for it, but would also expect that with enrollment across a wide variety of sites, that it shouldn't dramatically impact our results, we should still have results that are interpretable in a general sense. I guess also, just to say if this is something experienced by fibromyalgia patients, we want to account for it and any therapy that we bring to the market as well. So it'll be interesting to explore it as we go.

Norbert Riedel -- Chief Executive Officer

I believe this has also been noted in diabetic neuropathy and other kinds of chronic pain it's not I think that uncommon or unique to fibromyalgia. And, I agree with Kathryn that we have the appropriate, I think geographic spread and powering to study to cope with it.

Operator

Our next question comes from the line of Marc Goodman from SVB Leerink. Your line is open.

Marc Goodman -- SVB Leerink -- Analyst

Hi Norbert, I was hoping you could give us some color on the enrollment for 295 in the studies, I mean, any type of color would be helpful to drop out so far anything I mean, where are we in the process? Thanks.

Norbert Riedel -- Chief Executive Officer

Great, Marc. Thank you, from previous communications that we don't actually offer any specific details on enrollment of our studies. I can share with you that as we design studies and basically best them out with respect to size as well as the timeline, we take into account numerous parameters, including dropout weight and alike. And as I made my comments in the prepared remarks, we are much to my delight on track with enrollment and confirming that the read-out of our data is in the first half of 2022.

And so you can deduct from that we are satisfied and pleased with the trial and how the time is actually conforming to what we have set out to be the likely parameters of this study. But that's typically where I limited to discussing our studies as they are ongoing studies. So far, so good.

Marc Goodman -- SVB Leerink -- Analyst

And then just a clarification on one of the things that Parkinson's and the Lewy bodies patients that you're enrolling, I think he said it was 100 in total, will this be pre-specified for both groups, and are you trying to do half and half? Are you just taking all comers in either? How is this working?

Norbert Riedel -- Chief Executive Officer

Marc, we're not pre-specifying or stratifying in a particular way. And so it's likely based on what we know about patient numbers and about the extent to which as patients are diagnosed and likely to seek entry into clinical trials that it will probably be a mixture of all of the three of Parkinson's MCI, Parkinson's, disease dementia and dementia with Lewy bodies. So yes, we expect a mixture but we haven't got any stratification.

Marc Goodman -- SVB Leerink -- Analyst

Thank you.

Operator

Our next question comes from the line of Ritu Baral from Cowen. Your line is open.

Ritu Baral -- Cowen and Company -- Analyst

Good afternoon, guys. Thanks for taking the question. I understand that you haven't nailed down the final design of the Phase 3 PTSD study. But as you think about Phase 3, study 1 versus Phase 3 study number 2 are huge, is the FDA generally in alignment that the two studies can essentially be identical? Do you think that you might have [Inaudible] populations that you might want to investigate separately? Could you address that? And then I've got a very quick follow-up.

Andy Kidd -- President and Chief Operating Officer

Yes, Ritu can address that for sure. And we should clarify, it's the Phase 2b study. And so we've not had an end-of-Phase 2 meeting. This was a Type C meeting.

I think when we say that, we believe that this study is positive could be used to support registration and could potentially be a pivotal study, as Norbert said in his remarks that's very much a matter of future FDA review. We certainly want to design the study to alive for that possibility. But it would be a matter for FDA, and what the data say. If that's the case, then we expect to complete one further pivotal study.

But I think what that would exactly look like, is part of what we would wait until we have FDA minutes. And until we have finalized the study design to comment on any more.

Ritu Baral -- Cowen and Company -- Analyst

Got it. And then just on your 458 cognitive study, you mentioned you're looking at multiple cognitive endpoints of transferring memory and executive function. How do you prioritize those three? Some of your competitors with different mechanisms also looking at Parkinson's cognition seem to be focusing more on executive function. But I guess I'm wondering if that's based on guidance or communication or payroll opinion.

Norbert Riedel -- Chief Executive Officer

So first of all, as you point out, it's an exploratory signal finding study. So we basically want to give us the opportunity to look across multiple neurocognitive results in no particular prioritized order. We know from 458 from the preclinical studies we have done that it is very much a compound active across the domains we are talking about executive function cognition learning. And that's what we actually want to confirm so that we can then use that information for the next study just like we have done in the other indication to be much more targeted as to what specifically we would then be looking for.

So here we give out definitely the opportunity to be border without prioritizing any particular endpoint per se. Anything? Do you want to add Khanna?

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

Yes, maybe just that the capacitor that you're referring to has made a comment, I think that they were expecting to see more of an improvement on executive function and not perhaps so much on attention. We don't exactly know what data may inform may have informed that expectation. I think, if you recall the preclinical data that we achieve in a model in non-human primates, the MPTP model, generated really robust findings across relevant cognitive domains. And so we have no prior such expectation.

And that's why we are studying all of these different cognitive domains utilizing the different endpoints and cognitive tasks in the different areas and we will see what the data tells.

Ritu Baral -- Cowen and Company -- Analyst

Great, thanks for taking the question.

Operator

Our next question comes from the line of Gary Nachman from BMO Capital Markets. Your line is open.

Gary Nachman -- BMO Capital Markets -- Analyst

Thanks. Good afternoon. Just following up on 458, just remind us why you're just using the 30-milligram dose, do you think there's a chance that you would need to change the dose at some point down the road, depending on the outcome of the study? And then while your focus initially on Parkinson's and Lewy bodies dementia, what are other cognitive dysfunction indications that it could potentially inform you on once you have that data in hand? Thanks.

Norbert Riedel -- Chief Executive Officer

Great. Thank you, Gary. So I take the first part of your question. Gary, I think I mentioned before that we do very extensive preclinical work in looking at dose ranges to where we see the most effective dose of our compounds.

And we then confirm the presence of the compound in healthy volunteers in Phase 1 to make sure we can correlate brain exposure to the preclinical models, we have now done studies in fibromyalgia in DPN and in PTSD. And I can say, with the full-year level of satisfaction that we have been pretty much right on target, picking the right goal or predicting the dose that would be the most effective dose in the ranges we have looked at. So here we have a pretty high level of confidence that the 30-milligram dose is the right dose to do this exploratory study. But without a doubt, we will in future studies, do those changes as well, which we will do for our own benefit and also because it is like the requirements that the agency would have.

But there's no reason to burden this first exploratory signal funding study with dose ranging on top of just specifically that you want to see. And then there was the second part of your question.

Gary Nachman -- BMO Capital Markets -- Analyst

Yeah, just the data that you'll have on the Parkinson's and Lewy body dementia patients. Yes, how is that going to inform you of other potential cognitive disfunction indications?

Norbert Riedel -- Chief Executive Officer

Yes, I think generally, and I think Harald ran through the mechanistic rationale earlier that in Parkinson's disease, part of the neurodegenerative process results in reduced NMDA function, but that's not unique to Parkinson's disease, quite a few different causes of cognitive impairment involve impaired NMDA function. And so I think, once we have clinical proof of concept in this area, we've always thought that we had broad applicability and multiple, different causes of cognitive impairment. And I think that remains our plan.

Gary Nachman -- BMO Capital Markets -- Analyst

Ok, thank you.

Norbert Riedel -- Chief Executive Officer

Thank you.

Operator

Our next question comes from the line of Chris Raymond from Piper Sandler. Your line is open.

Unknown speaker -- Truist Securities -- Analyst

Hi, this is Ally on for Chris today. Thanks for taking the question. So on the 783 data at SOBP, it was really helpful to see the additional analysis adjusting for baseline imbalances in the time since trauma for Stage 1 of the trial, just wondering if you've run that analysis on patients in Stage 2 of the trial and if we can expect to see that or any other additional analysis presented at some point. And then just related to that, hoping you could characterize the feedback from the PTSD physician community since presenting the data at SOBP just any color on what most stood out to that on the data set for the mechanisms of 783 or other aspects of the program that would be helpful to you.

Thanks.

Norbert Riedel -- Chief Executive Officer

Thank you, Ally. Great question. So I'm going to ask Harald actually provides you with the answers because he actually is the one who actually presented the data in most areas of the SOBP meeting. So Harald if you could tackle that one.

Harald Murck -- Vice President of Medical and Pharmacovigilance

Yes, of course, I mean, just to say if you want to adjustments of the analysis, we're really motivated by the data as a fell if you want to, there's some randomness, of course from a baseline perspective, if you don't know, particularly in a smaller study was the specific characteristics aren't as we presented on our poster, there was a significant imbalance regarding baseline severity and the CAPS-5 and also the time since the trauma. So this basically motivated us to do this additional analysis, which is I think, scientifically the right thing to do. We want to make sure that we compare this and not with anything else. Regarding Stage 2, we are in the somewhat unfortunate situation that a much smaller number than originally anticipated ended up in Stage 2, which basically makes Stage 2 much underpowered in order to come up with any conclusive resides also didn't look for imbalances in Stage 2, because the compound 11, 12 subjects were actively treated with, I think, 16 subjects in the placebo group.

This is just not meaningful, whatever would have been the outcome of this analysis. Regarding additional analysis, we wouldn't exclude that we are doing any additional post talk analysis based on evidence sometimes a nice publication comes out, you want to verify to see the same thing. But I would say that at this moment in time, the [Inaudible] analysis has been done. And I would say to our satisfaction, we understand the data structure quite well and move forward with this justification based on the data.

Norbert Riedel -- Chief Executive Officer

And Ally to your second part, maybe I kick it off, so mechanistically what we target with 783 is really a hypo function in the prefrontal cortex of an NMDA receptor activity. And what is well known to be conditioning to a fear that really describes PTSD and why people suffer from PTSD because they can properly extinguish that fear and consolidate that extension. And we have shown preclinically, that 783 is indeed active in the area of fear, extinction, accelerated fear extinction as well as consolidation. So we believe that this is a more mechanistic rationale that addresses the underpinnings of PTSD, compared to the only two other approved therapies in PTSD today, which I've always as I and of course, helpful when you have symptoms of depression as an example, but they don't really get to the underlying root cause of what makes the distinction between people suffering from PTSD and people who extinguish at home or without becoming PTSD sufferers.

That's important to keep pointing out. Harald, I don't know if you have feedback from KOH that we want to actually offer in fear.

Harald Murck -- Vice President of Medical and Pharmacovigilance

Yes, to be quite honest, I don't not that much feedback. As you know, this was a virtual conference. This was somewhat difficult to get into contact with people. We got ourselves quite a bit of feedback by getting in touch with KOH but nothing specific regarding our data.

Norbert Riedel -- Chief Executive Officer

Ok. So that answered your question Ally?

Operator

Our next question comes from the line of Selvaraju from HC Wainwright. Your line is open.

Unknown speaker -- Truist Securities -- Analyst

Hi team, this is Mason for Ram Selvaraju. Thanks for taking my question. So I was thinking about NYX-783 and came across a negative allosteric modulator owned by Novartis. They've licensed it from Cadent Therapeutics.

It's MIJ-821. And they're showing safety and efficacy in treatment-resistant depression. Wondering if you're tracking this and this could pave a precedent for TRD indications for NYX-783. Thanks for taking my question.

Norbert Riedel -- Chief Executive Officer

Yes, we're certainly aware of that program and we follow a decade and then partnered with Novartis, and then we acquired. We definitely follow it might be worth a little just refresher on the history of our program and where treatment in depression has played into that.

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

Yes, this is Ashish. You recall that [Inaudible] of course, was one out of our predecessor company Naurex. As we sold Naurex down again back in 2015. The impetus for that sale was Allergan's interest in the data we had generated on earlier chemistry, peptide chemistry, IV administered therapeutics for the treatment of depression, major depressive disorder, and DRD.

We had multiple, large well-controlled Phase 2 studies across two different peptides IV administered peptides demonstrating compelling effects in depression. As part of that deal, Allergan, and we engaged in a research collaboration around our Aptinyx spin-out that does put some field restrictions on Aptinyx, and included in those field restrictions is the area of depression. And so we will not be going into major depressive disorder in the near term.

Unknown speaker -- Truist Securities -- Analyst

Ok. Thanks for connecting the dots there. I'll get back in the queue.

Operator

Our next question comes from the line of Jessica Fye from JP Morgan. Your line is open.

Unknown speaker -- Truist Securities -- Analyst

Hi, this is Daniel for Jessica. Thanks for taking our question. One quick question here. We have heard about the impact of COVID on enrollment in other ongoing Phase 2 DPN studies.

I know you mentioned prepared remarks as well as in the Q&A that you remain on track for the studies to read out in the first half of 2022. So curious, to how much of an impact have the amendments you have made helped with enrollment?

Norbert Riedel -- Chief Executive Officer

Yes, great question. Thanks, Daniel. Kathryn, I want to hand that to you to just give a quick update.

Kathryn King -- Senior Vice President -- Clinical Development

Yes, I think we continue to monitor the impact of COVID on our trials. We're happy with the way things are progressing and manage issues as they come up, but we remain on track as we've described.

Unknown speaker -- Truist Securities -- Analyst

Thank you.

Operator

Our next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.

Norbert Riedel -- Chief Executive Officer

Charles, are you there?

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes, I was on mute talking to myself. Sorry about that. Thanks for taking the follow-up. I did have a question on 458 actually ask two questions.

So they're not multi-part. One is on the plan, the PD and DLB study that you're pursuing. For the PD patients, are these pre dopamine therapy patients? Or are they on a stable background? And I guess I'm wondering how you think PD cognition shows up relative to save movement disorder within that.

Norbert Riedel -- Chief Executive Officer

Great. I'm glad you took the opportunity to follow up as we have the time to do it. So Harald I'm going to hand it to you.

Harald Murck -- Vice President of Medical and Pharmacovigilance

Yes, so indeed, these are patients and just to be on stable medication, they can be treated as they would, although they have to be stable. These patients can have movement disorders, but we have an exclusion to that regard that people who have movement disorders, which will then touch here with the cognitive assessments, just from the motor aspects, would not be allowed to participate. So the general focus is on cognition, but of course, you have to make sure that there is no interference if you want, so between the motor dysfunction and just the capability to participate in those tests. So medication should be stable, but if people want to get out.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Ok, that's helpful. And then just a perspective build follow up to a previous question and how big 458 could be, or the mechanism how broadly applicable it may be. And I guess, beyond just highly prevalent disorders it seems like there are some neurodevelopmental disorders that are driven by α-synuclein. And yet, those disorders are really hard to treat.

And patients may benefit for a long time such as Gaucher or GBA associated Parkinson's, I'm wondering if you have any sense of maybe going to a more rare disorder paradigm, once you see a signal, if it's positive with 458 NPD?

Norbert Riedel -- Chief Executive Officer

Yes, it's great. Thank you, Charles. I think that as we typically go about it that's established that we have a reliable signal or set of signals. And then I think we are very open-minded to asking what else should be a target.

I like the idea of rare diseases of course. And so that goes back to the question of how broad can this mechanism be? And we would certainly look at diseases where a correlation is likely between an NMDA receptor dysfunction and cognitive impairment across the board of those that you also mentioned a moment ago,Yes, Harald go ahead.

Harald Murck -- Vice President of Medical and Pharmacovigilance

Sorry for that. So I just want to say it is indeed a very broad mechanism, in that regard that inflammation in general terms we've also to down regulation of NMDA receptors, even things like diabetes need to down regulation of an NMDA receptor. So I think mechanistically this would be the place to look at because that we believe, we will be able to [Inaudible] But indeed, is the county's generalizable mechanism with very much modifications.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Wait for the signal next year. Thanks.

Norbert Riedel -- Chief Executive Officer

Thank you.

Operator

We have a follow-up question coming from the line of Ram Selvaraju from HC Wainwright, Your line is open.

Unknown speaker -- Truist Securities -- Analyst

Hi, this is Mason again. Just a quick follow-up regarding NYX-458. I was wondering if you're aiming to coincide the data readout later this year with a specific conference in mind?

Norbert Riedel -- Chief Executive Officer

The data readout is actually the second half of next year to be clear. And Yes, I would say very much like we just discussed SOBP, we will look for the appropriate medical or scientific symposium that is suitable for the data presentation and discussion. But we are still quite a distance away from the data readout. So let's see where we come out and what then it is like the logical set of the conference we should consider.

Yes, you're welcome.

Operator

Back to Norbert for any closing comments.

Norbert Riedel -- Chief Executive Officer

We appreciate your time and your attention. Stay well and enjoy the rest of the day.

Operator

Operator signoff]

Duration: 52 minutes

Call participants:

Nick Smith -- Vice President, Corporate development, and Investor Relations

Norbert Riedel -- Chief Executive Officer

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

Myles Minter -- William Blair -- Analyst

Andy Kidd -- President and Chief Operating Officer

Charles Duncan -- Cantor Fitzgerald -- Analyst

Unknown speaker -- Truist Securities -- Analyst

Harald Murck -- Vice President of Medical and Pharmacovigilance

Laura Chico -- Wedbush Securities -- Analyst

Kathryn King -- Senior Vice President -- Clinical Development

Marc Goodman -- SVB Leerink -- Analyst

Ritu Baral -- Cowen and Company -- Analyst

Gary Nachman -- BMO Capital Markets -- Analyst

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