Aptinyx Inc.
Q1 2019 Earnings Call Transcript

Published: 14 May 2019

[Operator:]

Good morning and welcome to the Aptinyx First Quarter 2019 Financial Results Conference Call. At this time, all participants are on listen-only mode. Following the formal remarks, we will open up the call for your questions. Please be advised, the call is being recorded at the Company's request. At this time, I'd like to turn the call over to Nick Smith, Senior Director of Corporate Development and Investor Relations at Aptinyx. Nick, please proceed.

[Nick Smith:]

Thank you, operator. Good morning and welcome to Aptinyx's first quarter 2019 financial and operating results conference call. This morning, we issued a press release with our first quarter 2019 financial results along with the business updates and upcoming milestones. The release is available on our website under the Investors and Media section. Today on our call, Norbert Riedel, our President and Chief Executive Officer will review recent business and clinical highlights. Then, Ashish Khanna, Chief Financial Officer and Chief Business Officer will review the financial results. In addition, Andy Kidd, our Chief Operating Officer is with us today 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 under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change. Except as required by law, Aptinyx disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. Please see the forward-looking statements disclaimer in our earnings release issued this morning and the risk factors in the Company's current and subsequent filings with the SEC. It's now my pleasure to turn the call over Norbert.

[Norbert Riedel:]

Thank you, Nick and good morning everyone. We appreciate you taking the time to join our quarterly call today. Given the proximity of this call to that of our 2018 year-end results, I will try to be somewhat succinct in my opening remarks. As you recall, at Aptinyx, we are leveraging our proprietary discovery platform to develop compounds that modulate NMDA receptor. The modulatory mechanism of our components is very different from other approaches to the NMDA receptor. As we have shown for our clinical studies, this modulation enhances synaptic plasticity which is critical for sensory processing and processes associated with attention, learning and memory. This noble approach has yielded encouraging results thus far. In the first quarter of 2019 marked another period for the company as we continued to build on our understanding of the wide-utility of this mechanism to assess numerous under-searched diseases of the brain and nervous system. Our pipeline programs are advancing rapidly and we expect to have further Phase 2 studies ongoing in four different indications across our three product candidates by the end of this year. Before getting to our recent designs in progress, I want to highlight that just last week, Henry Gosebruch was elected to our Board of Directors. Henrey is currently the Executive Vice President and Chief Strategy Officer at FV. He brings considerable industry expertise and insights to the team from his time at FV and also from the 20 years he spent at JP Morgan where he was most recently the Co-Head of the North American M&A Group. I will now review with the recent results of our clinical studies and how these results inform our ongoing and plans development efforts across the pipeline. As we reported in January and discussed in detail on our year-end 2018 call, our Phase 2 study of NYX-2925, in painful diabetic peripheral neuropathy or DPN, did not show statistical separation from placebo on the primary endpoint in the total study population. But importantly, a post-hoc analysis off the data revealed crucial findings that are now informing our past-forward in chronic pain. Specifically, the analysis demonstrated clinically meaningful and significant energetic effect of NYX-2925 in a sub-group consisting of 127 patients with advanced DPN; this sub-group represents just over 42% of the total study population. As observed in the total study population, the effects in the advanced DPN sub-group were even more pronounced in those patients not taking a concomitant analgesic medication. Importantly, the analysis also identified 50 milligrams as the most appropriate stores for us to take forward. These clinical findings have formed the basis for our second Phase 2 study in DPN which we expect to initiate in the second half of this year. As we are seeking to confirm the positive findings from the post-hoc analysis of all our first DPN study, we will focus next study in the following ways. We will study the 50 milligrams, it was clearly the best performing of the three doses we evaluated. We will focus on advanced DPN patients who have had DPN for a longer period of time, as they clearly showed a better response to NYX-2925. We will study patients not using analgesic meditation. And lastly, the study will have a longer treatment periods because we have not observed that plateau in the drug effect by week-4 in the first DPN study. In our second chronic pain indication, fibro myalgia, we are nearing the completion of the exploratory neuroimaging study we are conducting and remain on-track to reports results from this study in the next few weeks. Given the significant effects observed in the interim analysis of this study, including positive effects on pain, pain processing and other measures; we plan to initiate a larger Phase 2 during the second half of this year. We are finalizing the design of this next study and expect it to be similar in size and design to the DPN study based on the key findings across the two chronic pain studies that we have conducted thus far. Turning now to NYX783 in developing for patients with post traumatic stress disorder or PTSD. We initiated 144 patient of randomized double blind placebo controlled Phase 2 study in February. In the moment is ongoing and we expect the report to the guys from this study in the first half of 2020. As a reminder, we are guided into PTSD with NYX-783 by the strong preclinical desires we have observed with this compound in models of extinction learning. We believe that for the enhancement of synaptic plasticity, NYX-783 has the potential to address the underlying learning and memory dysfunction inherent in PTSD, rather than only targeting symptoms as the [indiscernible] pharmacotherapies do. Moving now to NYX-458. In development for patients suffering from Parkinson's cognitive impairment, we recently part of the from our randomized placebo controlled Phase 1 study, conducted in 62 healthy volunteers. In this study NYX-458 exhibited a favor with safety tolerability profile with no tax related serious adverse event. Furthermore, NYX-458 exhibited those proportional and predictable pharmacokinetic profile. Results also showed that NYX-458 readily crosses the blood-brain barrier allowing for drug levels in the brain that achieved concentration consistent with pre-clinically efficacious exposure level. Just as a reminder, each of our pipeline candidates achieved ample drug levels in the brain and have very predictable PK profile. Based on what we have observed with this molecule in the Phase 1 study, in combination with the remarkable cognitive effects demonstrated and recently the politics in a nonhuman primate model of Parkinson's disease cognitive impairments, we are currently finalizing the Phase 2 study design and anticipate initiating the study of NYX-458 in the second half of this year. Let me just briefly summarize. The invaluable insight revealed in our post hoc analyses of our first Phase 2 Study of NWY-2925 in DPN, including the block highly positive effects in advanced DPN patients at the 50 milligram dose level, have derisked and informed our further development in chronic pain and other bases for initiation of our next Phase 2 studies later this year. We remain very encouraged about the potential of NWY-2925 in this indication. We continue to make substantial progress across our pipeline. In total, we now have three novel clinical stage product candidates that are either in Phase 2 or are on the cusp of entering Phase 2 development and by the end of 2019, we expect to have four Phase 2 studies ongoing in painful DPM, in Fibromyalgia, in PTSD and in Parkinson's cognitive impairment with multiple data readouts anticipated next year. With that, I will now turn the call over to Ashish to cover our first quarter financial results.

[Ashish Khanna:]

Thank you, Norbert. In today's press release, we reported cash equivalents and investments of $136.6 million at March 31, 2019. This compares to $150.6 million as of December 31, 2018. We continue to expect that our current cash will be sufficient to fund our operating and capital expenditure needs into 2021, including readouts on all of the clinical studies Norbert just discussed. Revenues for the quarter ended March 31, 20 19 were $0.9 million as compared to $2.5 million in the same period in 2018. As a reminder, our revenues have primarily been earned from government grants and our ongoing research collaboration with Allergan. The decrease from 2018 to 2019, was primarily driven by the completion of work related to all outstanding grants in the first half of 2018. While these revenues do offset some of the costs associated with the early discovery and research work, we conduct our molecules from our chemistry platform, we do not rely on these revenues to fund our operations. R&D expenses were essentially flat at $12.5 million for the quarter ended March 31, 2019 compared to $12.2 million for the same period in 2018. G&A expenses were $5.7 million for the first quarter of 2019. This compares to $2 million for the same period in 2018. The increase in G&A expenses was primarily driven by increased costs related to employee compensation, patent related matters and professional fees to support ongoing business operations and compliance with obligations associated with being a publicly traded company. Finally, our net loss was $16.7 million for the quarter ended March 31, 2019 compared to a net loss of $11.7 million for the same period in 2018. With that, I will turn the call over to the operator for questions.

[Operator:]

Thank you. [Operator Instructions] And our first question comes from Gary Nachman with BMO Capital Markets. You may proceed.

[Gary Nachman:]

Good morning. Norbert, will you have a meeting or some sort of dialogue with the FDA before starting the larger Phase 2 Studies for 2925 and DPN and fibro later this year? Just to confirm that you have the right approach. And can you give us a rough idea how big these studies will be and how long you think it will take to run them? Thanks.

[Norbert Riedel:]

Yes. Of course we have an open I&D with the FDA Gary, because we've already had a Phase 2 Study, study that I outlined for you feels very lucky Gary on the key findings of all post-hoc analyses. The study is going to be roughly in the range of triple-digits in the study. As I mentioned, it's set to begin in the second half of this year and is to read out top line data in the second half of 2020.

[Gary Nachman:]

And that will be for both the fibro and the DPN? That will each be in triple-digits per arm?

[Norbert Riedel:]

That is correct. That question will line in quite similar on both sides [ph].

[Gary Nachman:]

And it will be two arms, right? It will be the 50 milligram and placebo?

[Norbert Riedel:]

That is correct.

[Gary Nachman:]

Okay. And then just the primary end-points. I'm assuming it's going to be the same as the initial Phase 2 Study - well, actually for the DPM it's probably the NR score. But fibro, I don't know what the primary end-point is for the current biomarker study. Might be different? So just if you could update us on those.

[Norbert Riedel:]

So remember the biomarker study is really one that in the initial ongoing study of about 24 creation, was aimed to given odds in neuroimaging biomarker for what is known to be areas of the brain involved in the perception and processing of chronic pain and that as really reported in the interim analysis that turned out to show highly statistically significant positive results in those markets. The study that is next is a more traditional study in that it uses odds as primary end-point, a subjective measure of pain, namely the Average Daily Pain Score that patients records and that will be tool for the DPN study and what's the same for that study, of course in our first Phase 2, and will also be tool for this particular form of biomarker study. Will not be a biomarker study, it will be an efficacy study using Average Daily Pain as the primary beta [ph] amongst several secondary pain measures -- secondary patient measures.

[Gary Nachman:]

Okay, that's helpful. And last question. Just any update on our cancer personnel studies. Have you had any conversations with Allergan or seen any additional data that might help explain why those Phase 3 studies and depression failed? And as far as you know, do they plan on completing the monotherapy study? Have you heard any more on that? I know it's hard because you're not completely in the now but any incremental data points would be helpful. Thanks.

[Norbert Riedel:]

Thanks for the question. We are really not any more in the know on [indiscernible] in what Allergan just closes on that study. Because our research collaboration agreement we have with Allergan is not a collaboration that extends into rapastinel. So I don't know any more than you do. When you look at the website, you see that there is a monotherapy trial in multiple Phase 3 that is ongoing and of course, the small molecules that Allergan opted on our synthetic chemistry platform is currently in Phase 2 studies but our information is limited to what's in the public domain.

[Operator:]

And our next question comes from Ray [ph] with Cowen. You may proceed. If you have your line on mute, you could let me try.

[Unidentified Analyst:]

I was muted, apology. Thank you for taking the question this morning. First question about the Fibromyalgia study again. Guys, are you looking at the full data right now? Do you have access to it if that would give you the confidence to move straight into Phase 2? And also, as you think about that final design, what learnings from the DPN study are you bringing to bear? Are you going to allow background meds or is there a reason to think about that differently?

[Norbert Riedel:]

I think to be true -- as I just mentioned to Gary, we have of course, the interim data on the final hours of study, which was primarily for imaging but also used a number of secondary data to taking measures of pain in our population of patients. The completion of this study is really going to be done over the next few weeks. It's not quite ready yet but the interim study as well as the DPN study, for the second part of your question, really I think confirms very nicely that our mechanism of action of modulating DPN [ph] tends to really focused on the sense of manifestation of chronic pain, which is our hallmark in advanced DPN patients, which is why I point those out to be the population that we will focus on to the next Phase 2 Study. It is also a hallmark of Fibromyalgia patients that we have very nicely shown with the biomarker imaging studies that we disclosed interim data on in December, so clearly the Fibromyalgia study is in its final design informed by the interim analysis as well as informed by the GPN study that we concluded. And that's how we are finalizing the design and the size of that study at the time -- at the fellow time

[Unidentified Analyst:]

You have not seen the final Fibromyalgia data correct?

[Norbert Riedel:]

That is correct, we have not.

[Unidentified Analyst:]

And then as you think of Fibromyalgia, I mean do you think that there would be a need to focus on -- I guess not late Fibromyalgia patients but Fibromyalgia patients with a longer duration of disease. Do you think that Fibromyalgia is a neuropathic process from day one? How should we think about that aspect and then background to that, as you think about the Fibromyalgia study?

[Norbert Riedel:]

Yes. I believe if Andy could translate that question for you because he's sitting right next to me.

[Andy Kidd:]

Hi, it's Andy. It's a great question. Our perspective on Fibromyalgia is that there is a very strong centralized component to Fibromyalgia and we think that that's true from the beginning. Most Fibromyalgia patients are diagnosed with Fibromyalgia after experiencing symptoms for a while. So we're confident that as long as someone has had a diagnosis for a certain period of time, say 12 months, that they'll have a pretty well established central pain and that's a little different to DPN where there's quite a heterogeneous and sometimes quite a long period of onset and progressive peripheral disease. So still yes, we think that the diseases clearly are different but we're trying to apply some of the principles and learning from DPN to the Fibro study.

[Unidentified Analyst:]

Got it. And then…

[Norbert Riedel:]

The other thing -- just to comment as well as we will exclude concomitant analgesics from the Fiber study, just as another example in line with the learnings from the DPN study.

[Unidentified Analyst:]

Super helpful, thank you. And then as we look to the 458 Parkinson's cognitive impairment study, cognitive endpoints are always, I guess squishy for lack of a better word and certainly been problematic in Alzheimer's cognition studies. How should we think about the design of that study, the end-point, the variability, etcetera.

[Andy Kidd:]

Yes. It’s Andy again. We'll be giving you more information about that. That's the point that we initiate the study. But your point is well taken and we're spending a lot of time thinking very carefully about what cognitive endpoints we use and trying to make sure that they're both as informative and discriminating as possible and trying to apply one of the lessons learned as you point out from other cognition studies.

[Unidentified Analyst:]

Great. Thanks for taking the question.

[Operator:]

And our next question comes from [indiscernible]. You may proceed.

[Unidentified Analyst:]

I believe I'm with FCB learning and you're from Aptinyx, but we'll proceed anyway. No but a couple of questions. Could you first comment on the sort of inverted U shaped dose response? Mechanistically, do you have a basis for understanding why the 50 milligram dose outperforms better than the higher dose? And secondly, could you talk about the potential interference with other analgesics? Is that just a masking effect or is there some genuine interference? And then lastly, what effect -- well, are there any differences by different classes of analgesics? Is that opioids, annexes, other classes or is it things like -- look -- in the background; just a little bit more color on that would be helpful. And then lastly, what sort of barrier does that present to recruitment and then ultimately commercialization? If you're developing your drug on a background of patients having to withdraw from their existing analgesics. Thanks.

[Norbert Riedel:]

Thank you, Jeff. Those are terrific questions so I'll answer them in the same order that you actually raised them. With respect to dose response, it's actually quite commonly known that in CNS diseases, increasing doses at some point actually trustworthy effect that you see or at least no longer add to the effect that you're looking for. And if I look at our doses that be tested in the Phase 2 Study 10, 50 milligrams and 200 milligrams and sort of like a line that was what we predicted to be the results, I can confirm that the 200 milligram dose was considered by us a high dose, we tested it anyway because we have a huge therapeutic index and terrific safety margin results to act and therefore we could afford to push the dose very high but it clearly shows that the 200 milligram dose was not needed and was not quite as effective as the 200 milligram dose -- as the 50 milligram dose, I'm sorry. So that I think is really, really helpful to be confirmed now in a human population of patients. With respect to Conmed, I think I mentioned before that we allowed for Conmed because we were advised at the time that we wouldn't be able to unload patients unless we did include or allow for the inclusion of at least one concomitant illnesses medication. It turns out after we basically looked at the data, that's about half the patients -- we are not on comment in so that I think is a really, really important observation coming out of that study that clearly says to your point, that we can readily recruit patients that are not on a concomitant medication as they enter our study. Our next study was to 2925. I don't know if I can comment on all facets of comment because those patients in our study that had the concomitant medication, we are for the most part on get a pension. And so I can speak for get a pension being one that dampened the effect of 2925. Does that extend to other classes? I don't know. Probably yes because it's quite similar, maybe some both as well because they are essentially acting drugs but I only have data really for have a pension. And I think it has to do with there being most of those sort of like modes of action in the brain and overlapping sort of like mechanistic ways in which the brain addresses pain. So the fact that our pension does indeed reduce the benefit of 2925, is actually not terribly surprising. Really -- I would say the answer is in our view, a resounding no, it will be not be number one because as I mentioned to you, it is a patient population that we are looking at that has not to be benefited from any kind of currently available neuropathic pain medication. And even if we were to, let's say in a commercial setting, even if we were to actually look at patients that have failed a previous therapy with an existing and established neuropathic pain drug, I think it would be a huge, huge market for our combat 2925 even in a second daily or tertiary setting of treatment of patients. So we have looked at that carefully and I don't think it is a barrier, nor is it going to be a limiting factor on the commercial opportunity for the 2925.

[Andy Kidd:]

Just to add one point onto that. It's certainly possible and we've had feedback externally from people who've done a lot of studies in chronic pain, that the Conmed issue, just as a clinical trial discipline is potentially in the placebo arm that you could have an increase in compliance or in compliance with any concomitant medications for the weeks that you're participating in a clinical study. If you think about being reminded to complete a daily pain diary and having a regular clinic visit, there is certainly a perspective among clinical trials to chronic pain that that the placebo groups sort of take -- start taking their concomitant medications with greater regularity. That we didn't see a particularly outside placebo effect in your studies but that is an important point, I think to also bear in mind with concomitant. And just a last point on the other drugs you mentioned, opiates, non-steroidal anti-inflammatory. Those are routinely excluded from chronic pain studies, they were excluded from our last round of studies and they'll be excluded from our future studies as well. They're not-- they're also not widely used as particularly effective in chronic pain.

[Unidentified Analyst:]

Thank you very much for the clarification.

[Operator:]

And our next question comes from Charles Duncan with Cantor Fitzgerald. You may proceed.

[Charles Duncan:]

Good morning, thanks for taking the question. Lot of good questions asked already but I wanted to ask for a little bit more detail on the diabetic painful neuropathy study that you plan to start soon. I think you mentioned that it was going to be a longer period of dosing and I'm wondering if you could provide some more detail on that. Would you anticipate 8 or 12 week dosing? And then, also with regard to patient heterogeneity, you talk about treating patients that had a longer experience with DPN, and I'm just kind of wondering how you would define that or reduce the patient heterogeneity that could compound results out of that study?

[Norbert Riedel:]

So on the first topic, it will be a 12-week study. The study we actually conducted and reported on recently was a 4-week study. I mentioned in my comments that we have not seen a plateauing effect of 2925, and that we saw a progressive decline in pain course from week 1 to 2, to 3 to 4; and so we have all the right reasons to assume that the study would show -- actually even greater benefit if we go past the 4-week that we have in the first study, so the second study will be a 12-weeks study. That's also in line with what is typically looked at by FDA with respect to chronic pain trials, and we'll just be consistent with that. On the DPN or duration of disease; in the first study, again, you're sort of like are guided but what you discuss with your advisory board and your clinicians -- we have actually said that you have to have a diagnosis of DPN for at least six months, and it's turned out in our post talk that as we looked further out, several years out actually, that if you suffered from DPN for a longer period, three years, four years or longer than that, that you actually showed the most benefit in the study with our 2925 in DPN. And I think that's really logical; when you consider that painful diabetic neuropathy truly starts in the periphery where the nerve damage occurs, and only as it becomes a chronic state of pain but it actually shows a central manifestation that we target with our mechanisms. So our mechanism of action, I think aligns very well with the observation in our study that patients with a longer duration of disease show the most benefit in response to 2925; which is why we say that's being such a large population, I mentioned 127 out of 300 patients or about 42% readily allows us to focus the study on those patients where we believe the mechanism of action is most relevant.

[Charles Duncan:]

It makes sense, I appreciate the added color, Norbert. And then with regard to -- I know you've kind of addressed sample sizing and you probably need to finalize this but when you consider this effect size that you're assuming, I guess what are you assuming in terms of the effect sizes and that could drive a sample size. I'm really wondering if there's any chance that this study could prove to become one of two pivotal studies or would you anticipate this study in forming another couple of studies in centralized pain, maybe to include both, DPN and Fibromyalgia?

[Norbert Riedel:]

Great question. I would say -- look, we I think approach this in a very measured way in saying let's do the next study, let's integrate the learnings and observations of the first study, and adequately power it to confirm the results that we have seen in that subpopulation of advanced patients. I don't want to go out of the limb today to speculate on whether or not this could indeed qualify to be a pivotal or registration trial while I know the agency has become very much more willing to consider that. I would say let's see what the data tell us before we actually jump to conclusions as to where it takes us next. At this point, the focus is really on confirming the results of the first study, namely that -- at the dose of 50 milligram in advanced DPN patients without Conmed, we should readily see a confirmation of the very strong efficacy besides that we have. Just as a reminder, I think that population, we saw a difference of 1.2 points on the numeric grading scale in Average of Daily Pain Scores, and that's a 10-point scale or 11-point scale from 0 to 10. And if you look at the population of advanced DPN patients without Conmed, that just became at 1.8 delta with a very, very clear indication that that is very clinically meaningful, and that's why we are so confident that that's the right thing to do to confirm that in the study that we have outlined here today and that we are kicking off in the second half of this year.

[Charles Duncan:]

And that was only in 4-weeks. And just last question if you allow me, moving over to 783 and the ongoing PTSD study; I know it perhaps is early days but is there anything you can say about the patient sample that is being enrolled, at least on a blinded basis? Are you comfortable with the characterization of patients that appear to be enrolled in that study? And can you provide us any insights on whether those are mostly military PTSD patients or not?

[Andy Kidd:]

Yes, Charles, it's Andy. Yes, it's a great question. We are obviously applying the current DSM-5 diagnostic criteria, and we have a kind of baseline caps 5-score that the patients have to meet. We are studying a range of different trauma types, it's a little early in enrollment yet to kind of see what we're getting but we would expect a mix of military and civilian trauma and we're certainly interested in studying both.

[Charles Duncan:]

Okay. Thanks for the added color and taking my questions.

[Operator:]

And our next question comes from Jessica Fye from JP Morgan. You may proceed.

[Jessica Fye:]

Good morning, just two quick ones for me. Maybe first one following up on Ritu's [ph] question on the Parkinson's cognition study. What duration of study do you think you would need to be able to demonstrate an improvement in cognition and establish partially offset? And then second one, for 783, for that Phase 2 study; what's a clinically meaningful difference on the clinician administered PTSD scale? Thank you.

[Andy Kidd:]

Thanks, Jess. It's Andy, great questions. Like I said before, we will get more color on the 458 study when we announce it's initiation. A couple of considerations; we certainly saw as you probably recall from our preclinical primate data, extremely rapid and pronounced impact on some quite sophisticated cognitive endpoints in the preclinical setting but we're obviously cognizant that other drugs have taken a while to show an effect on cognition endpoints in clinical trials, so we're kind of balancing those perspectives and we'll give you more detail on that study at the appropriate time. On 783, so the cat score has a number of different components and there is 20 key questions that are enumerated on a 4-point scale; so it's kind of out of 80. Patients with cat scores greater than 30 are kind of considered to have more moderate to severe PTSD. And generally speaking, an improvement of a few points, say five or six points is considered to be a good response. But again, this is something we're viewing this study as our first in human study and we're looking for a signal of efficacy of what the drug does. We're looking at the overall cap score, we're looking at other endpoints, we're also looking at some scores of the caps. And so it's not so much that we have one specific outcome in mind as to what we're looking for and it kind of depends on I think that the general pattern or efficacy signal that we see with the drug, which again like I say, it's a first in patients studies so we're kind of just interested in learning what that is.

[Jessica Fye:]

Great. Thank you.

[Operator:]

Thank you. I’m showing no further questions at this time. I' would like to turn the call back over Norbert for any closing comments.

[Norbert Riedel:]

Thank you, operator. And thank you everyone for your questions and for taking the time to join us this morning. As we have followed lines, because of all of our studies conducted to date, we have been substantial insight that further inherence and optimism we have above the prospects of all the novel pipeline candidates. These candidates stem from our proprietary discovery platform, and we believe they have significant potential as therapies for difficult to treat and largely underserved neurological condition. We plan to conduct and readout four Phase 2 studies over the next 18 to 24 months, all supported by our strong balance sheet; and we are looking forward to upcoming readouts from these programs. We remain committed to first-class execution across our robust pipeline and to providing the best possible treatment options for patients suffering from diseases of the brain and nervous system. We look forward to update you further throughout 2019, and I want to thank you again for participating today. Have a nice rest of your day.

[Operator:]

Thank you for joining us today. You may now disconnect. Everyone, have a great day.