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Aptinyx Inc. (NASDAQ:APTX)
Q3 2021 Earnings Call
Nov 09, 2021, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good afternoon, and welcome to the Aptinyx third quarter 2021 financial results conference call. [Operator instructions]. 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 Flavin, senior manager, corporate development and investor relations at Aptinyx.

Patrick, please proceed.

Patrick Flavin -- Senior Manager, Corporate Development and Investor Relations

Good afternoon, everyone, and thanks for joining us on today's conference call to discuss Aptinyx' financial and operating results for the third quarter of 2021. Our press release describing financial results and recent highlights is now available on our website. Today on our call, Norbert Riedel, our chief executive officer, will review recent business updates; then Andy Kidd, our president and chief operating officer, will review progress across our development programs; followed by Ashish Khanna, our chief financial officer and chief business officer, who will review the financial results. In addition, Kathryn King, senior vice president of clinical and CMC operations; and Harald Murck, 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 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 statement disclaimer in our financial results release issued this afternoon and the risk factors in the company's current and subsequent filings with the SEC. I'm now happy to turn the call over to Norbert to kick things off.

Norbert Riedel -- Chief Executive Officer

Thank you, Pat, and good afternoon, everyone. We appreciate you taking the time to join us on today's call. Before we begin with updates from our clinical program, I would like to extend a warm welcome to Dr. Gilmore O'Neill, our newest colleague on the Aptinyx board of directors.

Dr. O'Neill has extensive experience in CNS drug development, academic medicine and as a practicing neurologists. He currently serves as executive vice president of R&D and chief medical officer at Sarepta Therapeutics, where he leads the company's research, clinical development, medical affairs, pharmacovigilance, and regulatory affairs functions. He also brings an impressive background in late-stage CNS drug development from his previous 15-year tenure at Biogen, where he has leadership roles across numerous programs in neurology, pain, gene and cell therapy, and rare diseases, including oversight of numerous global marketing approvals.

I am confident Gilmore will serve as an invaluable resource in helping to guide our future development and growth plans, and we are thrilled to welcome him aboard. These past several months have been a particularly productive time for Aptinyx. And we are looking forward to an active period of execution and multiple data catalysts ahead. Later this year, we plan to initiate our phase 2b development program of NYX-783 in patients with PTSD.

We also recently announced that we expect to report results from our phase 2b study of NYX-2925 in painful diabetic peripheral neuropathy in the second quarter of 2022. Meanwhile, enrollment in our studies of NYX-2925 in fibromyalgia, and NYX-458 in cognitive impairment is progressing well, with readouts 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 gross credit facility we secured during the last quarter, providing access to up to $50 million. Our current capital position is expected to fund phase 2 data readouts from each of our pipeline programs across 2022 and 2023.

Recall that during our last quarterly call, we announced our plan leadership transition, in which Andy Kidd will become president and CEO, Patrick will assume the role of executive chairman effective January 1, 2022. The rollout of that transition has continued to proceed very well, and our team is prepared to hit the ground running in the new year. I will now turn the call over to Andy to dive into more detail around each of our programs, beginning with NYX-2925 and chronic pain.

Andy Kidd -- President and Chief Operating Officer

Thanks, Norbert, and good afternoon, everyone. As Norbert highlighted earlier, we're very pleased with the progress made over the past several months across both of our chronic pain studies. In October, we completed enrollment in our phase 2b study of NYX-2925 in patients with painful DPN. The pandemic environment has clearly presented challenges across our industry, particularly for clinical research, Nonetheless, our teams superb execution and the engagement of patients and sites over the course of the past year has enabled us to complete enrollment at a steady pace.

The most recently enrolled patients must complete the 12-week treatment period followed by a 30-day safety monitoring period. We're then expecting to report data from this study in the early to mid-part of the second quarter of 2022. This phase 2b study is predicated on data from our previous phase 2 study in DPM. In the prior study, NYX-2925 showed the most robust effects in patients with more chronic disease, consistent with a centrally acting mechanism.

Based on those results, we enrolled patients in the phase 2b study who have been living with painful DPN over a period of four years or longer. We also did not allow patients to take concomitant analgesic medications during the study. In the prior study, we saw a greater ability to detect efficacy and separation from placebo in patients who were not on background pain medication. The primary end point of the study is the change from baseline in the weekly average of patient-reported daily pain, evaluated over a 12-week period using the zero to 10-point numeric rating scale.

While this is a phase 2 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 in painful DPN, we're also conducting a phase 2b study of NYX-2925 in patients with fibromyalgia. This study is evaluating two dose levels of NYX-2925 and has a larger enrollment target of approximately 300 patients versus a target of 200 in the DPN study.

Enrollment in the fibromyalgia study continues to progress well, and we expect it to read out in mid-2022. Let's turn now to NYX-458, our product candidate in development for the treatment of cognitive impairment associated with Parkinson's disease and dementia with Lewy bodies. This is a program about which we're incredibly excited given the strength of our preclinical data with NYX-458 in translatable models of cognitive impairment. Furthermore, we've recently seen an enhanced enthusiasm for development of new therapies for cognitive deficits associated with neurodegenerative disorders.

NYX-458 is currently under evaluation in a first-in-patient exploratory phase 2 study to assess safety and tolerability and to detect therapeutically relevant activity on cognitive deficits, utilizing specific measures of attention, memory, and executive function. This double-blind study is comparing a 30-milligram dose of NYX-458 with placebo in approximately 100 patients with cognitive impairment associated with Parkinson's disease or dementia with bodies over a 12-week treatment period. Enrollment in this study is progressing steadily and we continue to anticipate reporting data in the second half of next year. Finally, we'll discuss NYX-783, our product candidate in development for the treatment of posttraumatic stress disorder.

We will soon be initiating the first of two planned phase 2b studies of NYX-783 in patients with PTSD. This phase 2b program follows on our previous exploratory phase 2 study in which we observed encouraging improvements in PTSD symptoms among patients treated with NYX-783. The first phase 2b study will evaluate once-daily dosing of 50 milligrams of NYX-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 NYX-783 versus placebo is expected to kick off in the first quarter of 2022.

Each study is expected to enroll approximately 300 patients, include a 10-week treatment period and used the regulatory standard primary endpoint of the CAPS-5 total score. We believe these phase 2b studies if positive, are well positioned for consideration as registration supportive based on discussions we've had with the FDA. Of course, this will ultimately be a matter for the agency to consider and decide on at a later date, should the studies prove successful. As you can see, we have a lot of activity underway across all of our programs and in these areas, and we're looking forward to upcoming study initiations and a series of data readouts next year.

With that, I will now turn the call over to Ashish to review our third quarter financial results.

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

Thank you, Andy. As you heard from both Norbert and Andy, we are pleased with the progress we've made on 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 2 study readouts upcoming. We were pleased to secure a growth capital credit facility from K2 HealthVentures, 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 2 data catalysts across all of our clinical development programs and extends our operational runway 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 of $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 year-end, we are both financially and operationally well positioned ahead of the multiple data catalysts we expect in 2022.

With that, I'll now turn the call back over to Norbert.

Norbert Riedel -- Chief Executive Officer

Thank you very much, Ashish. As we have housed the start of the new year, we remain focused on continuing to execute across all of our clinical development programs. With multiple phase 2 readouts over the next 24 months, and anchored by a strong balance sheet, we are well prepared as we have here a potentially transformative period of value creation for patients and shareholders alike. We are happy to take your questions now.

Questions & Answers:


Operator

Thank you. [Operator instructions]. The first question is from the line of Ritu Baral with Cowen. You may proceed.

Ritu Baral -- Cowen and Company -- Analyst

I wanted to ask about the next readout of the 29 -- 25 DPN study that's completely enrolled. What is the -- what do you think the final -- since you have final study conduct or at least drop out, what do you think the final powering on the study is? What should we be thinking around the primary endpoint of the numeric rating scale for pain? And I think more importantly, given the changes patients with more longer chronic pain and no come, what should we be anticipating the placebo to be compared to last time? And then I've got a quick follow-up. I promise it will be quick.

Norbert Riedel -- Chief Executive Officer

Thanks for the question, Ritu. As you can well imagine, we have discussed this with quite a number of clinical KOLs and I'm going to have Andy give you our thinking as to what we expect with respect to meaningful difference in treatment versus placebo group.

Andy Kidd -- President and Chief Operating Officer

Yes. Thanks, Norbert. In terms of the clinically meaningful effect, I think we've always said that anything above the pain score difference between active and placebo of 0.5 or greater would be clinically meaningful. It's always a little bit hard to create a single cutoff like that.

It obviously depends a little bit on safety profile. I think the better tolerated the drug, the lower difference is clinically meaningful. We think we're powered in the range of what is a 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 out in terms of final enrollment and discontinuations. And so -- 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 won't know if that was successful until we see the data.

Ritu Baral -- Cowen and Company -- Analyst

Got it. And then there's a range of secondary outcomes listed on clinicaltrials.gov. I think about 12 ranging from patient global impression to fleet score to use of rescue medication. Is there a hierarchical analysis of the secondaries within the statistical analysis plan? Or can you at least sort of prospectively direct as to which ones you think are the most clinically important.

Norbert Riedel -- Chief Executive Officer

Andy, do you want to take that as well?

Andy Kidd -- President and Chief Operating Officer

Yes, certainly. So I think we'll discuss or, I guess, deferred detailed discussion of the statistical plans until we have data to talk about. But I do think the -- obviously, other than the primary end point measures of global impression are certainly interesting. I think some of the other measures of pain other than just average daily pain, which we're looking at are interesting as well.

This is a study though where, as you know, patients with DPN pain is really defined the condition and a lot of weight is really on the primary endpoint here.

Ritu Baral -- Cowen and Company -- Analyst

Got it. Thanks, Andy. Thanks, Norbert.

Norbert Riedel -- Chief Executive Officer

Thank you, Ritu.

Operator

Thank you Ms. Baral. The next question is from the line of Charles Duncan with Cantor Fitzgerald. You may proceed.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Good afternoon, Norbert, Andy, and team. Thanks for taking our question. Also I had a question about 2925 and then I wanted to ask you about 458 quickly. Regarding the painful beta neuropathy study that is fully enrolled, I guess I'm wondering if you could remind us about the no concomitant pain medications.

And was there a waiting period? And I guess, I'm wondering how you established that they stayed off drug? And then secondarily, is there an open-label extension component to that study? And if so, are there any enrolls in that? And then I had a question about the safety database that you could imagine, would be required going forward in that indication?

Norbert Riedel -- Chief Executive Officer

All right. Charles, those are actually three questions, but let's take them in the order which you asked. And I think I'm going to have Andy and Harald tackle this. Maybe Andy can kick it off and do it step by step.

Andy Kidd -- President and Chief Operating Officer

Yes, sounds good. So I can -- I'll hit a couple of points. I think in terms of the no conmeds, yes, it depends which conmed, of course, you're talking about as to whether or not it was possible to actually wash off that medication as part of the screening period of the study. So some drugs that are more difficult to discontinue it was not considered as part of the protocol.

The patient can work with their physicians separately to come off that drug if they wanted to. And then after that, once they understood that was required to screen from the study, they can come on stream from the study. Within the screening period, there were some of the shorter acting medications that patients washed off over a period of up to four weeks. So that was sort of how that was handled.

And then I think in terms of open-label extension, there will not be an open-label extension period for these studies. But we would certainly in future phase 3 studies would expect to have an open-label extension. And I think in terms of safety database, right now, we have not met with FDA to discuss the requirements for an NDA. There is prior guidance on chronic pain that we are using as a guide, but we will not have a definitive sense of the requirements until we have an end of phase 2 meeting with FDA after data.

Harald, do you want to cover kind of any more details on the wash-out period and then how we made sure that patients weren't going back on that other medication?

Harald Murck -- Vice President of Clinical and Medical Affairs

Yes. I mean at the end of the day, we, of course, are monitoring any concomitant dedication during the trial. And here is for some medical reason, a patient needs to get any kind of medication. That's, of course, something which would be a protocol deviation, but we would be from a medical perspective, acceptable.

We just want to make sure that patients are at the same starting point at the beginning of the trial. So not allowed medications are washed out. I think it's important to keep in mind in that regard that only those patients should be considered for the trial versus doesn't interfere with their, let's say, general well being, of course.

Norbert Riedel -- Chief Executive Officer

Does this answer your question?

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes. No, very helpful. I appreciate the color. Just hopping over to 458, if I could ask a question about the cognitive impairment and PDL, are you collecting any biomarker data, including biomarker data, which is not like something you get from blood or whatever.

But so for example, quantitative EEG or any measures of brain activity in that study.

Norbert Riedel -- Chief Executive Officer

Harald?

Harald Murck -- Vice President of Clinical and Medical Affairs

So actually, we are not looking at the etiological markets, but a number of blood biomarkers. So there are certain things, for example, inflammation plays a role in those parameters, which may be relevant. So we have, let's say, some type of a biomarker program in place. But of course, we are somewhat limited.

I would think that the primary outcome varies so the computerized cognitive tests should be regarded more as biomarkers as well. They are of course, kind of an experimental approach to what people do with their cognitive function. What we are trying to do as a second step is to see which of those computerized cognitive tests do correlate with clinical parameters, which then helps us to move forward into phase 2b.

Charles Duncan -- Cantor Fitzgerald -- Analyst

And then a follow-up to that, in that patient or sample, are you enrolling patients that you would consider to be relatively advanced in their Parkinson's disease progression and therefore, possibly going to experience hallucinations or anything else beyond cognitive impairment. Thank you. I'll hop back in the queue.

Norbert Riedel -- Chief Executive Officer

Harald, you can take that as well.

Harald Murck -- Vice President of Clinical and Medical Affairs

Yes, yes, yes. Basically, this allow patients -- we are not allowing people who are treated with neuroleptics with a very small exception where we have a new elastic or sleep induction, but not for the treatment of [Inaudible]. So patients have to be on a level that they didn't happen or not expected to experience any housing which, of course, can happen in particularly in patients with Leybold dementia. Regarding the severity of Parkinson's disease from a motor perspective, of course, we have to make sure that subjects are all tested during the on period, which can, of course, also end the year with give testing.

And there is a range, if you want so of subjects we allow in one of the criteria which is really in the -- the investigator has to make this assessment is how much do the motor dysfunctions interfere with the participation in the clinical trial, which basically means how much are these people -- these patients are capable of doing the computerized cognitive testing, which needs, of course, some type of motor control. So that's a cutoff, which is based on the assessment of the investigator.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Perfect. That's one of the reasons I asked. Thanks for taking the questions.

Norbert Riedel -- Chief Executive Officer

Thank you, Charles.

Operator

Thank you Mr. Duncan. The next question is from the line of Joon Lee with Truist. You may proceed.

Joon Lee -- Truist Securities -- Analyst

Thanks for taking our questions. Just based on the prior question, it sounds like patients in phase 2b for DPN study needed to be actively washed out of concomitant payment as opposed to just enrolling patients who are just not on payments like they were in a phase 2a post-analysis because our understanding is that is made to a DPN study, the post-analysis that you did were in the group of patients who just weren't on concomitant payments. So by watching them out of the pain mess they were on in phase 2b that they were needed to be on payment. What kind of bias that created in the post analysis? And I have a follow-up.

Norbert Riedel -- Chief Executive Officer

Andy, I think you can start that. But just to be clear, it is not Joon. It's not as if we were only allowing patients who wash off a concomitant pain medication. We have those that are not to begin with on a concomitant medication as well as those that was off.

So just as a clarification. So I don't give you with the wrong impression on the study design.

Andy Kidd -- President and Chief Operating Officer

Yes, Norbert, exactly. I was going to make that point that I think the question from Charles covered if and when a patient washes off medication, not that, that was the only way to get into the study. I think quite a large number of patients in the study will not have been on one of those concomitant analgesics to start with. And actually, as a reminder, in the last study, there were patients washing off drugs to get into the study, you were only allowed to on one other analgesic.

So actually, the group of patients that -- in the last study that we're not taking a concomitant medication did include quite a few patients that washed off. They pay medication of some kind. I think we may have made the point in the past that a lot of them were not taking something like abatement for gablan/daloxatine, but there were other drugs that you had to wash off. And actually, there were still a number that we're taking one of those drugs and washed off.

So I think it's likely to be a fairly similar population to what we saw in the last study.

Joon Lee -- Truist Securities -- Analyst

OK. OK. Thanks for the clarification. And one more thing I wanted to understand better is in one of your data slides for DPN, you have a slide with those on concomitant meds and a second chart with those with advanced DPN, I believe, four or more years.

But do you have a chart for data where the patients are both not on concomitant meds and with advanced DPN, what does that look like? I'm just curious if they have greater than two-point improvement in NRS or something like that.

Norbert Riedel -- Chief Executive Officer

Yes. So we do have this data and we can look at the actual numbers. But those that were -- had a longer duration of disease for years and longer. And we are not on a concomitant medication have the strongest benefit and treatment effect when you compare the active against placebo.

Joon Lee -- Truist Securities -- Analyst

That make sense, but just curious if that data has ever been presented.

Norbert Riedel -- Chief Executive Officer

Yes, we are looking at after as we speak. So if we can find it right away, we get back to you.

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

So, Joon, I want to make sure -- this is Ashish. I want to make sure I understand the question correctly. You're looking for the effects in the last study in DPN among patients who were not on concomitant algetic medications and with advanced DPN greater than or equal to four years. Those data that we leave are on our website in our public presentations.

And they're sort of presented alongside the 127 patients out of 300 who had four years or greater advanced DPN. There's a --

Joon Lee -- Truist Securities -- Analyst

So 127 patients are not on concomitant med. That's the deal.

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

No, no. Sorry, let me clarify. 127 patients were only those who had greater than or equal to four years of DPN. A subset of those patients were presented alongside, it's about half of those patients.

64 of those patients were also not unconcomitant analgesic medication. And as you noted, we saw a very profound reductions in pain over just four weeks in excess of two points on the NRS scale and very significantly separating from placebo, albeit with a subpopulation in lower ends.

Joon Lee -- Truist Securities -- Analyst

Got it. Thank yo so much. And looking forward to the data mid to early second quarter of '22. Thank you.

Norbert Riedel -- Chief Executive Officer

Thank you.

Operator

Thank you, Mr. Lee. The next question is from the line of Marc Goodman with SVB. You may proceed.

Unknown speaker

This is Madhu on the line for Marc. I just have a couple of questions on 783 and the PTSD studies. I think you mentioned in the prior call that you would be able to talk a little bit more about your strategies in terms of managing placebo rates closer to initiation. So I was wondering if you could give us any additional color there.

And then secondly, given this may be one of the two registrational studies, what's the efficacy -- what sort of efficacy should we be thinking about and kind of like the bar there? Thanks.

Norbert Riedel -- Chief Executive Officer

All right. Terrific. Thank you. Again, I think we can few.

Andy, kick it off and then maybe Harald can supplement or complement accordingly.

Andy Kidd -- President and Chief Operating Officer

Yes. Sounds good. I'll take the second part first. I think we've said in the past and continue to believe that especially for a drug with good tolerability a separation from placebo in the mid-single digits of, say, three to five, low to mid-single digits is probably sufficient as long as it's statistically significant.

I think we've also talked about the change from baseline and the responder rate being factors that clinicians really, I think, are more focused on. With respect to placebo response mitigation, we can go into a little more detail on that, I think, when we actually initiate the studies. But there's a few points we can reiterate today. I think one is, obviously, the study design allows for a one to one randomization ratio between active and placebo.

We've also, I think, taken some consideration and other study design variables to try to make sure that they're on the side of minimizing or mitigating placebo effect as we've looked at screening criteria as we look at duration of the study and things like that. I think a key part of the placebo mitigation will also include training both for subjects sites and also for raters. And we can go into a little more detail on what that involves, I think, as we disclose the full study design on some more of the details over the next few months.

Harald Murck -- Vice President of Clinical and Medical Affairs

Yes. And yes, maybe just to add to that, we actually took an early visit out the more visitant actually have patients the higher placebo response rate. Also, we reduced the number exposure to the PTSD question now, the celebrating scale and there's an investigator-rated scale. In the previous trial, you did both in this trial, we just focused on the investigator one, which really half the exposure, and I think they should have a huge effect on the placebo response as well.

Operator

Thank you Mr. Goodman. The next question is from the line of Myles Minter with William Blair. You may proceed.

Myles Minter -- William Blair -- Analyst

Thank you for taking the question. Just on 2925 to start off with. On the evidence for a potential deepening of response with 12 weeks of therapy in the phase 2b trial, Do you have any other evidence outside of the prior four-week data that we're seeing that doesn't seem to plateau it still looks like it's on the efficacy enhancing trajectory. And also the six-week data that I think was the best out of the preliminary firmly data.

I'm just trying to understand the 12 weeks of therapy how much additional efficacy we can sort of expect?

Norbert Riedel -- Chief Executive Officer

Yes. So I think you already mentioned some of our previous observations, Myles, and thanks for the question, by the way. In the earlier study, we did see, like we typically do see a pretty rapid onset of activity or efficacy. And in the 50-milligram dose, it's that we selected to be the dose of the current phase 2b study, we saw a very linear decline from week one to week two to week three to week four, with a very clear indication that we would likely see additional improvements thereafter.

While typically in studies like this when you look placebo begins to plateau. So both of those should contribute to even better and stronger separation than what we already saw. And Ashish mentioned a moment ago that the results we had, in particular, in advanced DPN in the absence of concomitant pain medication was a very, very dramatic reduction of two points in the 10-point rating scale. So I think that is a context that we find to be very encouraging and supportive of the current study.

The fibromyalgia study that you mentioned, likewise, had a rapid onset. While we did not see it in the lower dose, it was quite readily observed in the 200-milligram dose, which was given about two weeks -- actually, two weeks after the lower dose. And so the same applies here. And in that study, as we pointed out, it was not just average daily pain was worth a pain here was questionnaire.

It was the promised fatigue scale. All of those very strongly correlated with the 200-milligram dose being very efficacious which we like to actually point out because we are not relying on a single endpoint. We look at multiple patient reported outcomes or in this study in addition to that biomarker results that all actually clearly move in the right direction to support that this mechanism seems to be pretty part and solid in how it changes the brain physiology.

Myles Minter -- William Blair -- Analyst

OK. And then just a clarification question on involvement number in the phase 2b. I think it's 229 participants that sit on clinicaltrials.gov. If you can't tell me the number you ended up with, can you tell me whether it's over or rounded up.

Norbert Riedel -- Chief Executive Officer

If we can tell you the number -- we can't -- we told you the number we ended up is like 229.

Myles Minter -- William Blair -- Analyst

All right. Sorry, in line. OK. The final one for me is on 458, the preclinical work that you've done.

I think I've seen data on nonhuman primates with MPTP injections that don't cause motor dysfunction. Just wondering have you done that work in alpha-synuclein because obviously, patients don't inject themselves with MPTP apart from a few which is how we found out MPTP actually is a model. But just wondering whether you've done any additional preclinical work there in alternative models.

Andy Kidd -- President and Chief Operating Officer

Considered actually the alpha-synuclein model looked at, I think, quite carefully after we'd already done the nonhuman primate MPTP work. And I think there isn't really a well characterized -- or we weren't comfortable there was really a well-characterized cognitive deficit in that model, that it would be meaningful to kind of show that we addressed. So we haven't looked at that. But I think we were not uncomfortable with the fact that the MPTP model does not display severe motor deficits.

A lot of work went into the development of that model to try to replicate the cognitive effects that are 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 doesn't create a severe motor deficit at the same time. So it was a model action we were very comfortable with and thought was translatable and the best model to look at.

Myles Minter -- William Blair -- Analyst

It kind of make sense. Thanks for taking the questions.

Operator

Thank you Mr. Minter. The next question is from the line of Gary Nachman with BMO Capital Markets. You may proceed.

Unknown speaker

Thanks for taking our questions. This is Ed [Inaudible] filling in for Gary Nachman. My first question is regarding 783 for PTSD. What are some theoretical safety concerns having a higher 150-milligram dose? And can you remind us if there were any previous talks that you thought and what was the highest dose evaluated there?

Norbert Riedel -- Chief Executive Officer

Yes, sure. Let me kick this off. So of course, we know from our preclinical models of which we employ quite a number that the dose of 50 that we already tested in the dose of 150 efficacious and safe, which is important to mention. We also have our phase 1 data, which is single and multiple ascending dose data which go much beyond the 150 milligram dose.

So in our case, we are really fortunate to have consistently seen a very, very favorable safety and tolerability profile. While other compounds in development might be dose limited because of safety or tolerability concerns that is not the case in our studies with these compounds. And so based on the preclinical work we have done and the phase 1 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 without at all entering the space of being concerned about safety or tolerability.

Unknown speaker

Got it. And then one more follow-up for me. For the 458 cognitive impairment and 295 fibroma studies, how has enrollment been tracking for those studies, given the increase in hospitalizations due to the delta variant? And how many patients have been enrolled so far in those studies.

Norbert Riedel -- Chief Executive Officer

Well, it's great question. I'm going to have Kathryn answer that for you.

Kathryn King -- Senior Vice President, Clinical and CMC Operations

Yes. We're tracking well in both the 458 study in cognitive impairment and 2925 in fibromyalgia and things are looking to be on track for our data readout mid and then second half of next year. We certainly have been watching carefully the impact of COVID across the trial, but we continue to stay on track.

Unknown speaker

Great. Thanks.

Operator

Thank you Mr. Nachman. The next question is from the line of Chris Raymond with Piper Sandler. You may proceed.

Nicole Gabreski -- Piper Sandler -- Analyst

Good evening, guys. This is Nicole Gabreski on for Chris. Thanks for taking the question. I guess, just around fibromyalgia, I know this is nitpicking a bit, but it looks like timing for the phase 2b data update has just been modified from first half '22 to now mid '22.

I guess, can you just provide any clarity around this change in language? I know the primary completion date on clinical trials has been June 2022, and it doesn't necessarily sound like you guys have had any enrollment issues. So I'm just wondering maybe if you could be thinking about potentially releasing results around a medical conference. So just any clarity around that would be great.

Norbert Riedel -- Chief Executive Officer

OK. Thank you for the question. Let me make one comment, Myles, just to correct myself, I did not formally mention in my script the 229 for the patient number in the DPN study. But it's on the government website, of course.

And that's why I said we told you the number, I mean at more in the sense of the number is publicly available, OK? Just for a correction. On the question of enrollment 458 in aboard enrolling as planned. We're really pleased with that, just like we were for the DPN study. And as we have done for the DPN study, we will provide better guidance or maybe more definitive guidance as we complete enrollment.

But at this point, we think that the fibromyalgia study is likely going to read 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 complete enrollment. And for the 458 study in Parkinson's and Lewis body dementia that is still on track, of course, as we mentioned, for second half of 2022 is supported by the enrollment numbers we have.

And so no reason to actually change those time lines that we communicated before.

Nicole Gabreski -- Piper Sandler -- Analyst

OK. That's very helpful. And then maybe just a quick second question on 783. Just around managing enrollment between Study 1 and 2.

I know that the study starts are staggered. But I guess, is there any concern that enrollment in Study 1 could take longer than expected? If patients or docs are kind of holding out to enroll patients with the higher 150-milligram dose for Study 2. I guess have you heard any kind of feedback on that.

Norbert Riedel -- Chief Executive Officer

Why don't you add that. Kathryn can give you the answer to that.

Kathryn King -- Senior Vice President, Clinical and CMC Operations

Yes. Our strategy there is to actually put the different studies at different investigator sites. So and where the patient geographically lands or where they're comfortable going to the clinic, they will not have the option of those studies. They will be enrolled in the study that, that clinic is running.

We think that, that reduces us and also gives us a representative sample across both studies, which is important as we advance that development program.

Nicole Gabreski -- Piper Sandler -- Analyst

That is very helpful. Thank you.

Operator

The next question is from the line of Ram Selvaraju with H.C. Wainwright. You may proceed.

Unknown speaker

This is [Inaudible] on for Ram. Thanks for the update. All of your programs are progressing very well, cohesively in terms of initiation, enrollment, and readouts. Just to shift gears, are you able to share any impact progress in your discovery pipeline in new receptor systems biology target indications that you're excited about and that you wish to reveal.

Norbert Riedel -- Chief Executive Officer

That's a great question. And I think it gets too little attention typically when we report. So maybe just as a reminder to our audience here, we have been synthesizing these positive elastic modulators for quite some time. We have designed and synthesized and profile more than 1,200 of them.

And of course, out of that pool, we advance those that are currently in the clinic, we have a number of compounds ready to be further advanced into IND at the right time, and that gives us a really rich portfolio of compounds to choose from as we advanced the programs further. That's the latest on the preclinical part. And of course, as we discussed before, part of what we investigate with our compound is where on the receptor do they bind. They bind to another binding domain within that domain, the tight differ from one compound to the next, but it's a new previously not described domain where the compounds bind.

We can characterize that pharmacologically, we can also characterize it quite nicely with our molecular biology tools, where a single point mutation in the binding domain or binding sites and completely abolish the effect of the compound. And so we have quite an extensive library of preclinical data that support the pharmacology and the receptor engagement of the compound. And perhaps there is an opportunity for us to present that a little more broadly at some point because I do believe it does make us the leader in this space of positive allosteric modulators acting on the NMDA receptor.

Unknown speaker

Fantastic. Thank you, Norbert.

Norbert Riedel -- Chief Executive Officer

Yes. You're welcome.

Operator

Thank you Mr. Selvaraju. The next question is a follow-up question from the line of Myles Minter with William Blair. You may proceed.

Myles Minter -- William Blair -- Analyst

Yes, sorry, Norbert, but no need to apologize. My question is actually to Ashish. You've got a debt facility in place and also an active ATM. Are we expecting that you're just going to draw down both of those continuously.

You're going to wait for a data readout and sort of how do you think about utilizing both of those facilities moving forward to fund the pipeline.

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

Yes. Thanks for the question, Myles. I think that we've always been attentive to the balance sheet and we'll, of course, continue to be. But we're pleased to be in a position with a strong balance sheet that funds multiple phase 2 data readouts actually across each and every clinical program in our pipeline in fibromyalgia and DPN and PTSD and in cognitive impairment.

That gives us really nice flexibility both with regard to cash and the access to capital both ahead of the data, but also through the data. I don't think we're in any rush or need to think about incremental financing. We'll appropriately think about balance sheet enhancement at the appropriate time, but then especially in support of the next steps in development, but we're in a good position right now.

Operator

I am showing no further questions at this time. I would like to turn the call back over to Norbert for any closing comments.

Norbert Riedel -- Chief Executive Officer

Thank you, operator, and thank you all for your questions. We appreciate your time and your attention. Please be well, and enjoy the rest of your day. Bye-bye.

Operator

[Operator signoff]

Duration: 50 minutes

Call participants:

Patrick Flavin -- Senior Manager, Corporate Development and Investor Relations

Norbert Riedel -- Chief Executive Officer

Andy Kidd -- President and Chief Operating Officer

Ashish Khanna -- Chief Financial Officer and Chief Business Officer

Ritu Baral -- Cowen and Company -- Analyst

Charles Duncan -- Cantor Fitzgerald -- Analyst

Harald Murck -- Vice President of Clinical and Medical Affairs

Joon Lee -- Truist Securities -- Analyst

Unknown speaker

Myles Minter -- William Blair -- Analyst

Kathryn King -- Senior Vice President, Clinical and CMC Operations

Nicole Gabreski -- Piper Sandler -- Analyst

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