Praxis Precision Medicines, Inc. Q4 FY2021 Earnings Call

Good day and thank you for standing by. Welcome to the Praxis Precision Medicines for Q and FY2021 corporate update Q&A call. At this time, all participants are in a listen-only mode. After the speaker's brief presentation, there will be a question-and-answer session. And I like to hand the conference over to your speaker today, Alex Kane, Vice President of Investor Relations and Corporate Communications, for a very brief presentation, please go ahead.

Thank you. Good morning, everybody. And thank you for joining us today for our Fourth Quarter of fiscal year 2021 corporate update Q&A call. With me on the call is our President and CEO, Marcio Souza, our Chief Medical Officer, Bernard Ravina, and our Chief Financial Officer, Tim Kelly. Following the press release and video update issued earlier this morning, we will focus today's call and your questions to provide additional perspective on the updates provided earlier. We ask that you keep to one question initially and then please feel free to rejoin the queue for follow-up questions as needed. Before we proceed, I would like to remind you that during today's call, we may make certain statements that are forward-looking and subject to various risks and uncertainties. For additional detail on forward-looking statements and the risks associated with our business, I encourage you to consult our SEC filings, and in particular, our 10-K filed today. With that, I will now pass the call over to the Operator to open up the line for Q&A.

Thank you. And our first question will come from the line of Yasmeen Rahimi from Piper Sandler. You may begin.

Good morning, team. Thank you so much for taking my questions, and we really like the new format of pre-recording them remarks. The first question that I had for you that we get quite a bit from clients is, now as the studies already have completed, or in the last stretch of enrollment completion, and you're looking at the patient population. Can you give us an idea of how homogeneous is the patient population that you've gotten into Aria? I know Bernard, you've made some remarks earlier, but if you could just elaborate a little bit more, what you see, what's the standard deviation? Just an HMD 17 baseline score among these populations. Any color that you could see on the baseline that could be helpful.

Thank you so much for the call, and I appreciate the feedback as well on the format. So I'll hand over to Bernard, but maybe my quick remarks are spot on with what we're expecting with a lot of effort to get there, because there were a lot of controls put in place, as Bernard reminded us earlier today. We're very happy where we are, but Bernard why don't you expand on that.

Certainly. Our eligibility was HMD 17 out of 23 or higher, and typically participants come in at a few points above that threshold. The important point to note is that we experienced a higher-than-expected screen fail rate, which indicates that our eligibility criteria and review processes were effectively implemented. Without these measures, we might have included individuals who either did not have Major Depressive Disorder or lacked sufficient severity. Regarding standard deviation, we focused on the change from baseline, which is crucial for powering, and it aligns with our expectations at around seven points. Overall, it appears that the processes and assumptions we established when designing and powering the study are proving to be accurate.

Thank you team. I have another question regarding historical studies on Major Depressive Disorder. Have you analyzed the percentage of the treated population that shows either a high or low response? I'm trying to understand the differences between the treatment group and the placebo group. How confident can we be that some of those with lower HMD scores are actually receiving treatment and not placebos? Any insights on that would be appreciated. Thank you for addressing my questions.

If you look back at the last 30 controlled trials conducted on patients with moderate to severe major depressive disorder, there are two to four trials that have reliable data at the two-week mark. The results are consistently close around that two-week point, and we expect to see a clear separation that will enhance the understanding of sleep and anxiety, which has been observed in the last quarter. We anticipate clear results in just a few days, maintaining the expected outcomes without straying from the Hamilton Depression Rating Scale (HMD 17) scores mentioned. Currently, we are focusing on blinded data. Therefore, any comments made by me or Bernard would be purely speculative. Our goal is to achieve an effect size of approximately 0.4, which translates to three points on the HMD 17 for our primary endpoints. We have a solid target for the number of patients needed, and we are in a solid position for that. The number of participants who have completed the study by Day 15 is promising, and we feel very positive about the outcomes. Historically, as we conduct simulations, we continue to feel optimistic about the results. Most patients show responses that align with the central tendency, with only a few rare exceptions in trials we don’t consider valid. Right, Bernard? Anything to add?

We don't know recovery in terms of retention rates here. And adverse events at brave, those all look as we predicted. So as Marcio said, it's all blood based on blinded data, review, aggregate data. So we can't tell you how the groups will separate when unblinded, but it just means that the assumptions overall in the planning stages appear to depend on that.

Thank you Bernard, and thank you, Marcio.

Thank you.

Our next question comes from the line of Laura Chico from Wedbush. You may begin.

Good morning, guys. Thanks for taking my questions. I guess I just have two, and I'll stick with Aria as well. I guess first, could you just remind us what steps you're taking to ensure patient compliance with therapy during that four-week window? And then the second question, and I apologize, thanks for releasing the prepared remarks as well, ahead of time that was wonderful. You discussed some of the changes, or I'm sorry, some of the changes you saw in the Phase 2a study with respect to anxiety, and I'm wondering if you could just elaborate a little further on your expectations in Aria for impacts, or potential impacts on anxiety. What's your sense in terms of the proportion of patients in the study that might have concomitant anxiety? Thanks.

We expect that in a population with moderate to severe depression, about 50% of individuals will experience high levels of anxiety. There are various ways to assess this. One method involves measuring it through MA, where we've observed roughly a 50% improvement on average in EMA. Therefore, we have similar expectations moving forward. Additionally, the DSM-5 includes a subcategory for individuals who experience anxious distress as part of their depression. We have been closely examining this in our Phase 2a study, where we anticipate that around 50% of patients will fall into this subcategory. While it's not part of our primary analysis, we will evaluate it nonetheless. Mechanistically, due to various reasons, we expect to achieve both antidepressant and anxiolytic effects, as indicated by the MD concerning anxiety and sleep-related items. There are multiple ways to understand this construct, but fundamentally, anxiety levels are inherently linked to moderate to severe depression.

On the compliance aspect that you inquired about, we utilize several approaches. It begins with selecting the right patients. We have discussed that a significant reason patients discontinue the trial is related to compliance issues. Additionally, the investigator's assessment of a patient's likelihood to adhere to the schedule is crucial, highlighting the importance of our investigators who are instrumental in making this trial a reality and taking our work seriously. Throughout the study, we implemented various parameters and systems. Given the duration of our GABAA gap study, which involves 28 days of dosing and an additional week of observation, it was essential to keep patients engaged without overwhelming them. We partnered with AiCure, using a customized version rather than their standard one. We found that the extended version lacked what we refer to as Praxis reaction time, which is vital for immediate intervention if issues arise. Their team worked closely with us to tailor this version, and we have someone consistently monitoring the study, which became a key tool for us. We have observed strong patient compliance and positive responses to the trial, which reinforces our confidence in the patient population. Ultimately, it is not just one factor driving our good compliance; it is a combination of various elements that contribute to adherence to drug and procedural requirements.

Thank you, guys.

Of course.

And our next question will come from the line of Ritu Baral from Cowen. You may begin.

Good morning, guys. Thanks for taking the question. I just wanted to have you guys help set expectations around what you might report, at I think it was Day 29 or Day 30. Marcio, I think you mentioned that you expect maintenance of effect. Does that mean you're expecting maintenance of statistical significance and just generally, what you expect at Day 29, what you might report beyond Day 29? And then you gave us very helpfully what your expectations were, could you speak to how you expect sedation to come in, and if that might be a differential driver too? Thanks, and then I'll hop back in the queue.

Thank you. We need to consider several factors here. Let’s start with safety. When we selected the 40 milligrams for a nightly daily dose, our hypothesis was based on various internal assessments to enhance beta power, which is our best indicator of the drug's presence in the brain. Importantly, this does not cause sedation or incapacitating side effects the following day, enabling patients to function normally. This has been a significant point for us. We are pleased with our observations so far, and the outcomes will be visible in a couple of months. Regarding the effects, with all necessary controls in place, we believe the drug will perform as intended. This suggests a decline in placebo responses in a controlled manner, rather than in an erratic fashion. We anticipate a moderate placebo reduction between Day 15 and Day 29, though still expect the drug to show a more substantial decline. Based on our communications with the FDA, it is not guaranteed that we will maintain statistical significance at Day 29, but it is possible. Currently, our standard deviation appears to be within expected limits, and the patient profile aligns well. We plan to provide updates in June when we share our results, and there is a reasonable chance we will see both a numerical and statistically significant separation by Day 29. We will report on various benchmarks, including MD 17, Day 15, Day 29, and global impressions on Day 29, along with any other relevant data. Our goal is to present a comprehensive overview of the drug's effectiveness, which will facilitate our discussions with the agency as we aim to initiate Phase III and a second registration trial later this year. This outlines our current objectives for the program.

Ritu, it's a good point to reiterate too. We're talking about maintenance of effect on treatment, and in our experience, in our Phase 2a study, we tried both stopping treatment after two weeks as well as continuing it for the full four weeks, and what we saw very clearly is when you discontinue, you do lose a point and a half, two points over the subsequent two weeks versus maintaining the effect when we treated over four weeks. So really, just speaking about the active arm, we look to see continued levels of reduction from baseline. And we do think that's important. You've got to continue the drug and be able to treat through an episode.

Got it. Thanks for taking the questions. I'll hop back in the queue.

Our next question comes from the line of Tazeen Ahmad from Bank of America. You may begin.

Okay. Thank you for taking my question. Maybe I'll focus on Essential tremor. So you've got the Essential1 study that's reading out this year, the Phase 2 top line. Can you just talk us through what information we should expect to see when that dataset does come through, and as far as the three doses that you're studying, 20, 60, and 100. Is it your expectation that you will see dose-dependent efficacy? And is there a chance that after looking at the data, you might narrow your focus of doses? And then I might have a follow-up. Thanks.

Thank you so much, Tazeen. Like there are three readouts for essential tremor right now, right step, what we're coming up with, the final cohorts for the Phase II with the randomized withdrawal, which are going to be reporting in May, then the 114, for instance show being essential tremor and Essential one, and I know your questions were centered on essential one. So I'm going to hand over to Bernard to talk about our expectations and why we designed it that way. What is the key objective here that is really to move to a Phase III shortly thereafter?

So Essential one is really designed to do just that, to provide the data that we can select a dose or a couple of doses for subsequent Phase III or Phase III as needed based on regulatory discussions. The key things we'll look at, of course, safety and tolerability. And we've talked about how important that is for this population. In terms of efficacy, we've talked about how we'll look at there in that landscape has been a focus on activities of daily living along with the modifications to scoring that the agency has suggested. And we'll of course look at measures of tremor. And we talked about the importance of objective measures of tremor, given that there's some challenges in just the visual inspection of floor effects, the way it's done in the Tetris. So if you look at all of those, in terms of expectations for dose response, we selected our doses based on our Sigma band biomarker. We do think there will probably be a dose-ranging or dose response on efficacy on those measures we talked about, whether or not it will be linear or it will cap out at around 60 milligrams. We don't know, but that's really the question for the trial. We know Sigma Bain tells us mechanistically about dose response, but we don't know how that translates into tremor reduction in function. Honestly, exactly the question will answer, and I think we'll be really well-positioned with the data we will get out of Essential one.

Okay. You are pursuing 114 as Marcio mentioned as well, in essential tremors. So what is your long-term strategy in ET? Are you going to pick one over the other, or do you think that both can exist for different parts of the market?

That's a great question. When we evaluate the markets and speak with physicians and patients, we find significant unmet needs. The essential tremor market is diverse, with varying requirements. For instance, younger patients with familial cases, which represent a substantial percentage, are looking for options to manage their tremors effectively. Their needs differ compared to those with less severe tremors, who might require relief only during specific tasks, while others with more advanced disabilities need consistent assistance. We see three main opportunities here. First, 114F can provide relief for those who require treatment continuously or as needed, acting quickly with a time to maximum effect of around two hours. This predictability offers either immediate tremor reduction or the option for extended use. Then there's 944, which involves titration for patients who choose a longer-term solution. Additionally, we plan to explore combinations of these treatments. Currently, our market assessment identifies about 3 million potential patients. We are unique in offering multiple mechanisms of action and possess a deeper understanding of the market dynamics, positioning us strongly in the essential tremor space. It's not an either-or situation; we aim to develop both therapies. Regarding our development strategy for PRAX-114, the trial is designed to answer a crucial question: can we identify a dose that effectively reduces tremor without causing daytime drowsiness? If the trial is successful, we will proceed with development; if not, we will discontinue work on this molecule, including 944.

Okay, and maybe to wrap it up, Marcio, for Essential1, what type of the Tetris score would you consider to be clinically meaningful? Thanks.

And I'm going to hand over to Bernard in a second, but one of the key things that we are moving away from, I would say, based on the agency or the FDA advice, is just the raw Praxis score. So there are two ways I'm going to be looking at this. The risk collaring walk of the ATLs, as they suggested, makes any change in the ATL meaningful. And we believe that's why the agents suggested that. Because now we are talking about any points that change is clinically meaningful. By going through accelerometers, for example, as Bernard mentioned the highlights today, now we're going to be able to see the true amplitude of the tremor changing. So we believe that a 20% or so change would be something quite meaningful. But Bernard, why don't you chime in?

Yeah, a couple of different points in terms of what's tremor is meaningful. What we see, it varies a lot from patient to patient. But what we see just in terms of eligibility. We think of this similarly to what we talked about EMD and depression. You need to verify that the score is correct, so we have visual confirmation by video, by an independent rater, same kind of thing. What we see is when people come in with tremor scores in the upper limbs, in the 10 to 12 range, a few things: they tend to have a lot of impairment in their activities of daily living. We also see those people have pretty robust improvements because they have enough tremor that you can reliably measure change. So as Marcio said, how much improvement is important; maybe it’s easier to measure by ADLs, but typically people think a 20-30 percent tremor improvement is about where you need to be or more above the baseline tremor. You probably need upper limb scores in the 10% to 12% range to really be able to measure anything.

Okay. That's helpful. Thank you.

Thank you.

Our next question comes from the line of Myles Minter from William Blair. You may begin.

Hey everyone. I'm just curious as to the 50% screen failure. Is that consistent across all sites in Aria or are you saying in some sites that are screening out a huge amount and others that are incorporating more?

Yes, Myles. It's generally consistent, although there may be slight variations. We're not experiencing situations where one site has a 95% screen failure and another only 5%. It's somewhat unusual, even based on the feedback from the sites, which is concerning because there are patients eager to participate in trials looking for relief from their symptoms, and they aren't getting that. However, it does provide some clarity regarding whether we are attracting the right patients for the trials we've discussed. So, it's a mixed situation, but there are no significant discrepancies among the sites we are monitoring, correct, Bernard?

Right. And Myles these are all really experienced sites. Their team has worked with before, so it's not like there's not a skew of sites driving inappropriate screenings. It's across-the-board and other sites have commented that the COVID environment is just different, and their screen fail rates are higher than what they've previously seen. It just goes back to emphasizing the importance of doing this and having that eligibility review process in place.

Yes, that makes sense. Let's move on to the next question, which I frequently receive. Your competitors are showing strong confidence in their anticipated results, and it seems that you are also quite confident about approaching those historic six to eight-point outcomes. When you consider the key factors integrated into the trial, such as the cypher product and its insights on MDD patients, have you been able to quantify what each of these factors contributes to a placebo response on a per-day basis, or is it more about collectively achieving a better, uniform patient population to re-enter the historic placebo response range? Thank you.

Great question, Myles. It all starts with enrolling genuine patients in the trial, which is perhaps the most crucial aspect. It may seem simple, but when discussing the inflation of HMD17, it's not just a minor increase; it's significant. In the industry, there are many professional patients involved in psychiatric trials, and we want to avoid their participation in ours. They can regress quickly, leading to abnormalities in the results. To our knowledge, there's really only one set of trials showing placebo effects exceeding seven or eight points, and those are recent and from the same sponsor, making them outliers compared to the norm. In our analyses, the idea of having a second confirmation could lead to a 30% to 40% reduction in control, which would approximately equal 3 or 4 points based on that using Safer. We have great respect for the fourth MS general collaborating with us on this, but it's not solely about Safer; there's also a verification process at the site and a Safer interview. That verification is likely the second most important factor; however, in a multifactorial analysis, we can never fully isolate individual factors.

It is true. There is certainly the most data on safer right, by far, and I do think it's like not to be tried, Myles, but it's having the right people at the table. When you have really experienced high-quality sites, you worry less about radar training and things like that, drift and their own imprint on placebo effect. So I think it's both the right site personnel as well as the right patient population. I think eligibility and site selection are probably the most important.

Okay, cool. Let's jump back in the queue. Thanks.

Thanks.

Our next question will come from the line of Douglas Tsao from H.C. Wainwright you may begin.

Hi, good morning. Thank you for the questions. My first question is about a competitor that has highlighted the quick benefits of their treatment. Since you have their drug, you've pointed out its effectiveness in addressing the entire episode. I'm interested in your perspective on the short-term benefits and what we might observe early on. When will you start measuring improvements in the Hamed?

Hey, Doug. Hi. Super important question as well. So maybe to start with what we know here, and I will go back and forth with Bernard. We're going to need two or three hop lives at least to start seeing something. Our first data points for Aria is on day four. Keep in mind that when you get very early days in any trial, there's something that is very rarely discussed or debated publicly. There's when, when to when. Meaning that there's only so many days patients can be assessed considering the window. We have to force or window which we don't like to do for those early days. But we should expect to see separation pretty early. That mechanistically will happen. I think that's why others have shown as well with a similar mechanism, labs, extrasynaptic. So not exactly the same, but similar mechanisms here. And as Bernard mentioned in one of the questions, once you start going down the road of treating these patients, there is no condition pre-clinically or clinically that you've seen or anyone to our knowledge that says that by treating with GABAA ATMs that it's partially or very extrasynaptic referring change biologically. They structure the physiology of the brands. So it means that we have to continue those for as long as the patient needs. It should be pretty obvious based on some recent trial results that those curves go back together and therefore there is no maintenance on that case. Our hypothesis has been from day one that you need to treat throughout the episodes. It's a shared hypothesis with the FDA when they told us that they see an episode of depression between three and six months. And if that's what we're going for, as we are, that we should show that we can treat those patients for a prolonged period of time. So in that regard, we don't believe in removing the drug until those patients feel stable, until their investigators, or their treating physicians in the case of going to markets, believe that they are at that stage now. Depression is not a chronic condition. I know we call this chronic, but depression is an exotic condition. And that's why we see some patients resolving and going down in terms of their symptoms over time. Treating the episode or not treating properly an episode is the number one reason why patients have problems afterward. So we're very committed to not getting patients to just relapse on their treatment. So our paradigm is, and is going to be training for long. We are, I would say on the lucky side, that we can, we have no restrictions to treat these patients for as long as we are treating right now, and our safety profile supports it.

The way we designed Aria focused on rapid onset, quick-acting antidepressant effects, and sustained results. Both aspects are critical, which is why we established the primary endpoint at two weeks. As Marcio mentioned, the first assessment after baseline occurs on day 4 and is conducted virtually to limit the number of visits that could inflate the placebo effect. The first in-person visit is scheduled for one week. However, Marcio pointed out that there are flexible time windows for these assessments, and if we are not stringent with the timing, the assessments can overlap. Therefore, we aim to keep the assessments closely aligned with those time points. Our design for Aria is intended to emphasize rapid onset and evaluate the durability of the treatment, so we are not making a choice between the two; both are clinically significant.

Okay, great. Hello?

Yeah.

Just a couple of quick follow-ups. One, just in terms of screening, I'm just curious, do you have data in terms of what the cause of most screen failures are? Is there something that's particularly predominant? And two, when do you anticipate starting at PPD study, and do you have timing on that?

Yeah. So we do it. Our team looks into this basically every day. Bernard and I and the rest of the leadership team look into this every few days in the week. By far, by a large margin, what is driving the screen failure rates is the HMD17 not being able to be confirmed. Which is again, I would say for how we've been doing this. And then the second is compliance with protocol or inability to comply, certain drug abuse, unfortunately, is very prevalent in mental health in general. One more reason to have good drugs to treat these patients. But those are smaller percent’s, I would say by a disproportionate amount, it's HMD17. Which reinforces everything we've been talking about expansion on placebo in other trials and so on if they're not careful or at home doing that. Tim, regarding your second question about our focus on perimenopausal depression, we are examining this market from two perspectives. Initially, we have observed strong proof-of-concept for PMG among patients experiencing moderate to severe depression during this lengthy phase of life, which typically lasts around seven years. Women significantly struggle with the changes during this period. When analyzing the market, two critical factors emerge. First, many women prefer to identify more with the menopausal aspect rather than the depressive stage, which influences different trading and regulatory pathways. Second, there is a range of symptoms related to mood that we believe we can effectively address. The market for PMG currently serves about 3 million women annually, and this could increase to approximately 9-10 million when we factor in additional symptoms. Therefore, from a market standpoint, it is quite intriguing. We have finalized our analyses and have a clear strategy for development; however, we need to reflect on our capital allocation relative to market dynamics. We are cautiously holding back for a few months to ensure responsible capital distribution and hope to resume trials shortly after Aria.

Okay, great.

Our next question comes from the line of Ritu Baral from Cowen. You may begin.

Hi guys, thanks for taking the follow-up. I just want to ask about the strategy behind having a second dose that you're pursuing in Acapella. First, do you anticipate that it will be a lower dose or a higher dose based on what you have seen pre-clinically, and second, if you just forget about the preclinical data and just answer that from a commercial perspective, where do you think the biggest need is just given psychiatrists are used to titrating all day long. So how do you think they want to approach this?

Acapella is primarily designed to address a specific question raised during our discussions with the agency. In examining this class, particularly with our 114, it’s more about the overall class impact. Increasing exposure in the brain doesn’t necessarily lead to a reduction in symptoms of anxiety, insomnia, or major depression. However, it does tend to result in an increase in side effects. There is a somewhat proportional relationship between dose and adverse effects, but this does not translate into additional benefits. As a result, we often receive inquiries about whether lower doses could produce effects without side effects, ideally in a very clean manner. From our studies with healthy volunteers, we have tested doses like 10 and 20 milligrams, which have shown to be very effective, even during the day. This is why we are using those doses for Essential Tremor in relation to 114, as the dose response is remarkably clear. Therefore, it made sense to explore these lower doses. According to our Beta power data, doses below 20 milligrams should not significantly impact depression, especially when administered the night before, at least as it relates to Major Depressive Disorder. Thus, that sets a baseline for us. We are also looking at increasing the dose to 40 milligrams to verify that everything is functioning as anticipated. Given this mixed population, moving to 60 milligrams seems appropriate to validate the hypothesis that side effects will scale with the increase in dosage without yielding further effects. This opens up the possibility for a broader dose range exploration. As Bernard mentioned earlier this morning, we do not have specific statistical power expectations for this trial, but we expect to observe trends. If we find that 20 milligrams is indeed effective, comparable to 40 milligrams, we may consider including that in our second trial. We will maintain transparency throughout the development process, which is why this trial is essential.

And I’d add into the set expectations, most intended presence doesn’t have the dose response effect on efficacy. So it's typically more of a threshold effect, so we don't necessarily know that this will be real dose-related efficacy. That would be an advantage in terms of we're getting at clinical use, so psychiatrists currently do titrate up, but there's very limited data to support that higher doses across any class of antidepressants are more effective. So I think if we were to show that, it would be tremendous benefit. Very useful clinically for people to be able to have a starting dose and know there's more efficacy to get as they go up. But they currently really are doing it on an individual patient basis.

Got it. Thanks for framing that. Very helpful.

Thank you.

Our next question, a follow-up, will come from the line of Myles Minter from William Blair. You may begin.

Hi, just on the pop bay of the 944-2A Study. I'm just wondering what the definition of the response for Quad is to be randomized into the withdrawal portion of that trial, considering the FDA is asking you to do not only trim up but also activities, the daily locus of the composite of both of those measures on the Tetris.

We will include everyone who was treated during the randomized withdrawal period as a responder group similar to what is done in a Phase 3 study. Our main goal, as we outlined in our remarks, is to determine the duration of the effect. Everyone who completes the open-label phase of the study will participate in the randomized withdrawal, regardless of the response level. However, this will provide us with data to help decide if we should conduct a true responders randomized withdrawal in the future. We will need to consult with the agency about the criteria for defining responders, as there are currently no fixed definitions.

Okay. So side-to-side, 12 patients will be going into that randomization stage regardless of whether they responded or not. And I think judging from what you've previously reported from part B and then on patients, yeah it's like 45 higher than that like a 50% response, right? Sorry.

Yeah.

That's correct.

Okay, cool. And then the final one from me is just I did notice for your earlier stage pipeline that you are looking to push more towards pediatric epilepsies, actually solidly dropping that focus, which I think is great. But can you just talk to a bit more color about that decision, and if you do see decent data out of the neurology studies, is that an indication that you'd proceed with, or you would just take that data and try and shape for the epilepsy programs out of those assets? Thanks.

Yeah, so Myles the foundation of how we screened drugs, as we discussed before offline, has been always used like genetics, epilepsy models that are highly projected. We have rights like a number of broadens, as you saw on the pipeline, we're a lot more comprehensive today than we were in the past that we've been brewing, and they're coming to a point now we are incredibly excited about that, and we believe they are viable. So for our company, our size, our resource, it made sense to pause and to ask what the strategy here is. What is the one that the market supports, the regulatory framework is clear. Patients are all there in needs, so we direct towards epilepsy including common epilepsy right now, but most of those risks can be using several additions. So we're not abandoning CNS in general; just focusing the resources we have towards the highest probabilities and the highest impacts. Now, in our trial, if it is positive, I think there are different avenues. There is one that we would continue developments. There is one that a partner would develop with us on those indications if it's more appropriate to that. So, we're going to continue to look into this, and the best drugs are the ones that make two patients to get for approval and get commercialized. If we are the right people to do that's great. If we're not, we all are going to be greedy and try to keep that and not do the job. And that's what this strategy is for.

Great. Thanks.

Of course.

Thank you, and there are no further questions in the queue at this moment. I'll just turn the call back over to Marcio Souza, President and CEO for any closing remarks.

Thank you very much everyone, and I really hope you enjoyed this form as we think it's fairly efficient, was based on feedback from a lot of few gave us. Maybe two remarks: you're incredibly excited about all the progress, much more to come in the coming months. Today is Rare Disease Day, as I mentioned, we are very excited about its continued development of drugs for those rare conditions, continued to really use the rare disease framework or the rare disease regulatory framework to get these drugs through. But there's also a moment in the world that mental health is taking yet another deep. We have an active war in Europe as we all know. And that always impacts how we all feel, and specifically the ones in our brothers and sisters in Ukraine right now who are fighting for their country. So I just want to remind that it is not a simple moment in time. Mental health is very important. We're very committed to have our world, where we recognize and celebrate more the healthiness in the part of mental health. And we're hopeful that in the near future there will no longer be any more wars happening here and there. And you all are going to be feeling a lot better about all of us as humanity because that's what we all are: brothers and sisters everywhere. So thanks again for joining. Looking forward to talking to all of you.

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.