Good day, and thank you for standing by. Welcome to Intra-Cellular Therapies corporate update conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automatic message advising your hand is raised. Please note that this conference is being recorded. I will now hand the conference over to your speaker host, Dr. Juan Sanchez, Vice President of Corporate Communications and Investor Relations. Please go ahead. Thank you. Good morning, and thank you all for joining us today on today's conference call to discuss the positive top-line results from Study 501. Our press release describing top-line results crossed the wire earlier this morning. The slides for today's call are available on the events and presentations section of our corporate website. Joining me today on the call are Dr. Sharon Mates, our Chairman and Chief Executive Officer, and Dr. Suresh Durgam, our Chief Medical Officer. Following these remarks, we will be opening the call for Q&A. I'm moving to Slide number 2. As a reminder, during today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions, and expectations. Those are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. This and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. Your caution is not to base on your reliance on these forward-looking statements, and the company disclaims any obligations to update such statements. I will now turn the call over to Sharon. Please move to slide number three. Thanks, Juan. Good morning, everyone, and welcome to today's call. We are very excited to be here today to share the robust top-line results from Study 501, our Phase 3 clinical study evaluating Lumateperone in patients as an adjunctive therapy to antidepressants for the treatment of major depressive disorder, or MDD. MDD is a highly prevalent, debilitating condition with the majority of patients not benefiting from their initial therapy. Therefore, there continues to be a great need for efficacious treatments with favorable safety profiles. If you go to Slide 4, as you can see on this slide, the results of the trial were incredibly robust, and we're very, very pleased with this overwhelmingly positive study. Lumateperone met the primary endpoint of change from baseline at Week 6 on the MADRS total score versus placebo, with an impressive 4.9-point reduction. The p-value was p is less than 0.0001, with a Cohen's d effect size of 0.61. Lumateperone also met the key secondary endpoint of change on the CGIS, with a p-value of less than 0.0001 and an effect size equal to 0.67. We are particularly pleased with these results, especially as it was an adjunctive treatment study. As Suresh will detail, our study included both clinician-reported scales, such as the MADRS and the CGI, and patient-reported scale, the QIDS, and we're very pleased with the improvements seen from both the clinician and the patient's perspective. Additionally, we continue to see a favorable safety and tolerability profile. To give you the particulars of the results, I'll now turn the call over to Suresh. Suresh? Thank you, Sharon. Good morning. Today, I will be presenting the top-line results of Study 501. I am on Slide 5. The objective of the study is to evaluate lumateperone 42 milligrams as an adjunctive treatment in patients with MDD who are having an inadequate response to antidepressant therapy. Let us start with the study design. This is a global, multicenter, randomized, double-blind placebo-controlled trial in patients who had inadequate response to ongoing antidepressant therapy. Patients were randomized 1:1 to receive lumateperone 42 milligrams plus antidepressant therapy or placebo plus antidepressant therapy. The duration of the study was up to 9 weeks. There were up to 2 weeks of screening period followed by a 6-week double-blind period and then a 1-week safety follow-up period. The key inclusion criteria were patients met DSM-5 criteria for MDD. Patients were required to have a MADRS total score of 24 or above, a Clinical Global Impression-Severity score, that is, CGIS, of 4 or above, and a Quick Inventory of Depressive Symptomatology Self-Report scale score of 14 or above, and an inadequate response to ongoing antidepressant treatment defined as less than 50% improvement for at least six weeks of duration. These criteria represent patients who are either moderately severe or severely depressed. The primary endpoint was mean change from baseline in MADRS total score at Week 6. The key secondary endpoint was the mean change from baseline on the Clinical Global Impression-S everity scale, or, CGIS, at Week 6. Moving on to Slide 6. You can see on this slide the demographics and baseline characteristics. The patients' average age was 45 years. The mean baseline MADRS total score was about 30, and the mean CGIS score was 4.6. We randomized a total of 485 patients. Now coming to the Slide 7, the primary endpoint, the change from baseline on MADRS total score to end of week 6 between Lumateperone 42 milligrams plus antidepressant therapy versus placebo plus antidepressant therapy. Here, you can see Lumateperone demonstrated statistically significant and clinically meaningful reductions on MADRS total score compared to placebo at Week 6. The least square mean reduction from baseline for Lumateperone 42 milligrams was 14.7 points versus 9.8 points for placebo. That is a 4.9 reduction with a p-value of less than 0.001, and you can see the actual p-value on the slide, which is much larger. The effect size was robust at 0.61. You can also see there was statistically significant efficacy starting at week 1, the earliest time point tested, and that improvement continued throughout the trial. Next slide. I am on Slide 8. Lumateperone also met the primary objective of the study, that is the CGIS. The Clinical Global Impression-S everity scale provides the clinician's overall assessment of the patient's depression severity based on clinician interview. This scale most closely resembles what happens in standard clinical practice. Lumateperone demonstrated a statistically significant and clinically meaningful reduction on the CGIS score compared to placebo at Week 6. Here, the separation also was seen at week 1, the earliest time point measured, and continued to improve through week 6. The effect size was 0.67, and the actual p-value is less than 0.001. You can see that on the slide. Moving to next Slide number 9. In this study, we included a measurement for the patient voice. We used the Quick Inventory of Depressive Symptomatology Self-Report, that is QIDS-SR16. This is different from the prior two scales, that is the MADRS and CGI, that I just described that are clinician-rated. The QIDS is a 16-item patient-rated scale of symptom severity in depression. It assesses key symptoms of depression. The baseline average score was 18. On this measure, lumatepirone 42 mg robustly improved depressive symptoms by an average of 8 points and had a p-value of less than 0.0001. Moving Slide 10. lumatepirone for safety. Lumateperone exhibited favorable safety and tolerability profile consistent with our prior studies. The overall discontinuation rate in the study was low at 6.6%. Lumateperone plus antidepressant therapy was 8.7%, whereas the placebo plus antidepressant was 4.5%. The overall adverse event rate for lumatepirone was 58%, and for placebo was 46%. Discontinuation rates for adverse events were 5.8% for LUMA and 0.8% for placebo. The most common adverse events defined as greater than or equal to 5% of LUMA and twice placebo were dry mouth, fatigue, and tremor. These adverse events were mostly mild to moderate and resolved within a short period of time. There was one serious adverse event during the double-blind treatment period in the placebo group and none in the lumateperone group. Moving Slide 11. in conclusion, in this adjunctive treatment study in patients with MDD who had an inadequate response to one or two antidepressants, lumateperone 42 milligrams plus antidepressant therapy demonstrated robust efficacy over placebo plus antidepressant therapy with respect to change from baseline to week six in the MADRS total score and in the CGIS score. Lumateperone 42 milligrams plus antidepressant was generally safe and well tolerated in patients with MDD. Adverse event safety profile in the MDD population was generally consistent with what we have seen in prior trials. Thank you. I will now turn the call over to Sharon. Thank you, Suresh. As you can gather, we're very proud of today's results. They provide important data on the efficacy, tolerability, and safety profile of Lumateperone for this clinical setting. With these latest study results, we continue to demonstrate Lumateperone's potential to help patients across a broad range of mood disorders, thereby advancing our vision of establishing Lumateperone as a drug of choice for treatment of mood disorders. This concludes our prepared remarks. Operator, please open the line for questions. Thank you. Ladies and gentlemen, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 11 again. Please stand by while we compile the interview roster. Our first question coming from the line of Jessica Fye with J.P. Morgan. The line is open. Hey, guys. Good morning. Congrats on these results. I'm curious, what did the MITT analysis entail, and can you talk a little bit about how it was modified and whether that was a pre-planned population? And then can you also comment even qualitatively on how the MADRS results looked on an overall ITT basis? Yes. Go ahead, Sharon. No, go ahead, Suresh. I think that's fine. I would just start by saying, to date, all studies with antipsychotics have used an MITT. I think, in this case, as Suresh will tell you, there's almost no difference, but he's happy to elaborate a little bit. Yes. In terms of the first question, it separated in all populations, MITT, ITT, every population. But in terms of the definition of MITT population, it's patients who are randomized, took the drug, and had at least one post-baseline value for MADRS. So if they didn't have any post-baseline value for MADRS, you cannot do the measurements. So it is patients who took the drug, had post-baseline measurements, at least one post-baseline measurement for MADRS. That is the definition of MITT. There are very, very few patients who didn't meet that criteria. You can see by the number, total number of patients. Yeah. Yeah. You can see by the total number of patients. You can add up the numbers, and there's one number difference. Great. And then maybe just as a follow-up, how does the strength of these results impact your thinking about the commercial opportunity in adjunctive MDD, if it does at all? Well, I think it strengthens our conviction. I think we've been saying all along that every study that we've done has, again, supported the mechanism of action of the drug and the results of every clinical study that we've seen. I think that I think we have been saying that we think that Lumateperone is really a drug of choice across the mood disorder spectrum. We've demonstrated in schizophrenia, in our adjunct sorry, in those patients who were being treated with Lumateperone for the treatment of schizophrenia, who also had comorbid depression, we were very robustly able to improve their antidepressant symptoms and their depressive symptoms, sorry. Then in our bipolar studies, these are patients with major depressive episodes. In our mixed-feature studies, both in bipolar and in MDD, and now in our MDD study. And I should say that, again, in adjunctive studies, as we've been saying all along, it is these patients already have some benefit from their antidepressant. And to be able to improve their depressive symptoms to this magnitude is really quite impressive. So it, again, confirms our beliefs and everything that we've been saying all along. I don't know, Suresh, did you want to add anything? No, this is good. Great. Thank you. Thank you. And our next question coming from the line of Andrew Tsai with Jefferies. The line is open. Hey. Congratulations on the dataset. It's great to see positive data these days. So can you talk about the strategy going forward in terms of FDA discussions around mixed features? Would you plan to talk to the FDA now with this dataset on hand, or would you wait until the next data readout in late Q2 before talking to the FDA about the path forward for mixed features? And secondly, as we think more about the drug's differentiation, which obviously drives uptake, can you talk to us about the significance of the week 1 efficacy that you see? I know some sponsors are thinking of getting a rapid-acting label claim if their Phase 3 succeeded. So would that be something you would plan to seek after talking to the FDA? Thanks. Of course. Thanks, Andrew. So first, as you know, we have our second Phase 3 study coming towards the end of this quarter. So we are going to get that data prior to having the opportunity to do anything else in any event. So I think that the first thing we're going to do is get that data. We will then go to the FDA with both studies and, of course, all of your supporting studies, which includes our mixed features. And they already have both the mixed features and all of our other studies. So I think that we just stay tuned. We'll be getting more data soon, as you know. And I think that we think our package so far is incredibly strong. So we're very optimistic here going forward of having our filing later this year. And then as to rapid acting, I think rapid acting has a particular definition. I think we're very pleased with the results that we've seen. And I think that the data speaks for itself. And we'll discuss all of this with the FDA once we have the next study as well. Thanks very much. Congratulations again. Thank you. Thank you. Our next question coming from the line of Brian Abrahams with RBC. The line is open. Hi there. Congratulations on the data, and thanks for taking my questions. Two from me. I guess, first off, adverse events look like they're mostly in line with what you've observed before with the drug. Can you expand a little bit more on what you saw with regard to metabolic AEs? I know that's something that's seen with a lot of other atypical antipsychotics with regards to prolactin levels, lipids, weight gain. And then secondarily, any changes that you might contemplate to the third phase three study now that you've seen the robustness of these results either now or if the 502 data looks similar? Thanks. So thanks, Brian, for the congrats and also for the questions. So as far as the safety questions that you asked about, you get those in your second tranche of safety data. So what we're doing so we'll get those very shortly, and we will tell everybody what they are. So we don't have that data yet. However, we can tell you that overall, so far, the drug looks very similar to everything we've seen in prior studies. As far as the third study, I think that let's wait and see how the second study looks. And I think it's a great question, and we'll have more for you on that shortly. Thanks. Thank you. I should say, though, we do think, obviously, this study is incredibly robust and very, very supportive of our thesis. Thank you. And our next question coming from the line of Charles Duncan with Cantor Fitzgerald. The line is open. Yes. Good morning, Sharon and team. Congratulations on these data. Look very strong. Thanks for taking the question. So quick question is on the 501 versus 502. Can you remind us of differences in clinical sites or enrollment criteria, if any, and whether or not this read has any impact on the probability of success that you have for 501 versus 502? There are different enrollment sites. Thanks, Charles. There are different enrollment sites because you don't want to be competing with yourself as you're enrolling patients, right? As far as the entry criteria, etc., etc., these studies are very, very similar, if not exactly the same. So I would tell you that everything is similar. As you can see on clinicaltrials.gov, you can see when we finished enrollment. So you can expect that there aren't many, if any, patients still going through the study. So that could impact the readout of this study as we're reading it out today. So we don't expect an impact on that. Very good. Second question, and then I'll hop back in the queue, is can you remind us of any post-6-week patient disposition? Was there any longer-term follow-up beyond the 1 week, or were patients given an opportunity to continue on drug? And then with regard to some of the observations such as dry mouth or fatigue, is there any chance that there was any functional unblinding on that, or do you feel like that really was mitigated by the study design? Thanks. Yeah. Just, I'll work backwards. We don't think there was any functional unblinding, and the percentages were low, and they resolved quickly. So I don't think there was a functional unblinding at all here. As far as were they treated for more than a week, yes, patients were given the opportunity to roll over, and many of them did. And I think that has been a very successful ongoing study as well. I should tell you that we have more than enough patients for our filing this year from a safety database. Suresh, did you want to add anything? No. Yeah. We have patients have gone into the open-label safety study. Thanks for the added color. That's great. Thank you. And our next question coming from the line of Marc Goodman with Leerink Partners. The line is open. Hi. Thanks for taking our question. This is Rudy on the line from Marc. Congrats on the strong data. It seems like the placebo arm only had less than 10 points of reduction in measures. Can you maybe remind us of your placebo mitigation strategies? And should we expect similar placebo effects from the ongoing Phase 3 Study 502? And a follow-up is if you have both studies are positive, what is your plan regarding the other study, Study 505? Thanks. I'll start with the second one because that's an easy one. I think that let's just wait. We are looking at our strategy for the second study for the third study right now. Let's not put the cart before the horse and say let's first have the readout of the second study, and we'll get back to that. I'm not sure I understood your question on placebo. I'm not sure I understood it, but I think we were able in the study to have good control over the placebo response. I don't know if you want to ask the question a little differently or if that's not answering your question. Yeah. It sounds normally we have in your prior studies, we have placebo response in 12, 13 points of reduction, but in this study, we only have less than 10 points of reduction in measures. Do you think that stands on its own? Yeah. I think each study stands on its own. I don't know, Suresh, do you want to add anything else to that, or? Yeah. I think that's correct. You had to look at each study on its own. We have taken measures to reduce placebo response. Having said that, you have to look at individual study independently. Okay. Thanks. Thank you. Our next question coming from the line of Jason Gerberry with Bank of America. The line is open. Hey. Good morning and congrats on the data. Just two commercial questions for me. Safe to say with this study in hand, you guys can start to make more significant investment in MDD pre-commercialization efforts ahead of the launch. So can you just help frame the sort of incremental investment that you think would go along with an MDD launch, just given that it's a slightly different, perhaps, prescriber-based but you can certainly leverage a lot of the call points you currently have? And then the second one is where do you see Caplyta specifically fitting within the atypicals approved for MDD? Do you see it displacing generics or just growing the pie? Just any color you can kind of put out there post this data. Thanks. Yeah. I missed who it was. Is this Jason? Yeah. It's Jason. Yeah. Great. Hi. Thanks. Hi, and thanks for the question, Jason. So the purpose of today's call is really to tell you our data, okay? We have an earnings call coming up. Please reserve that question for our earnings call. And I think as far as where does Caplyta fit, and can it displace generics? I think we do think Caplyta, with its efficacy and safety profile, should become the drug of choice to go to for the mood disorders. And I think as far as displacing generics, I think, as you know, this is all up to a payer. And so we have to see how this plays out with the payer environment. But we're very encouraged by the results that we're seeing today. Thank you. Our next question coming from the line of Jeffrey Hung with Morgan Stanley. The line is open. Hi. This is Michael Riad on for Jeff Hung. Thank you for taking our question, and congratulations on the top-line results. Given the MADRS reduction as an adjunctive is almost in line with what you'd expect as a monotherapy, have the data influenced your decision as to how you're approaching lumateperone development and MDD? Does the profile also fit well for first-line therapy? And any plans for that? Thanks so much. I'll start, and then I'll ask if Suresh wants to add anything. Thanks for the question. I think we are very pleased with these results, and we think that there is a real need for new adjunctive treatments to help patients. I think you're correct. This is a very, very strong effect size and change in measures. And I think we'll continue to evaluate this as we move forward. Thank you. One moment for our next question. And our next question coming from the line of Michael DiFiore with Evercore ISI. The line is open. Hi, guys. Thanks so much for taking my question, and congrats on the impressive data. Just two for me. I noticed that both trials allow the inclusion of patients with psychotic features. I'm just wondering if that could have driven this pretty robust effect size seen because it's among the largest effect size seen among any atypical adjunctive MDD trials. And if so, how many patients did have psychotic features in the study? So I'll start and ask Suresh if he wants to add anything because the short answer is no. It didn't drive anything. Okay. And I don't know the number of patients. I don't even know if Suresh has that data yet, but it would be few. Suresh, do you want to add anything to that? Yeah. There was very few patients with it. It's a single digit, so it's not many patients with psychotic features. Thank you. No, that didn't drive anything. Thank you. Ladies and gentlemen, in case there's enough time, we ask that you please limit yourself to only one question. Please stand by for our next question. Our next question coming from the line of Sumant Kulkarni from Canaccord Genuity. The line is open. Good morning. Very nice to see these results, and thanks for taking my question. I'm going to have to ask a two-parter. So given these impressive data, I think I should probably phrase this as when Caplyta is eventually approved for MDD, how confident is the company in going up against the currently large competitors in the space? And second, given the learnings from today's data and the lumateperone molecule in general, you've revealed some indications for 1284, which is the deuterated ODT sublingual form of lumateperone. But do you specifically plan to develop that product for any type of depression as well? I'm asking because of the obvious patent implications of that. Great. So thanks for the question, Samantha. I'll work backwards. So first, again, today's focus is on the data readout of Study 501. We obviously are moving ahead with the development of 1284 as well, and we can give you further updates on other calls that we have, including our earnings call. As to the first question, which is the larger question of how are we going to go up against the large competitors? We were asked that for schizophrenia. We were certainly asked that for bipolar. And I think we've shown you that as long as we maintain our share of voice, we're very effectively going up against the larger competitors. And we believe that with strong data as we have, we will be able to maintain our share of voice, and we will continue to be able to compete in this arena very effectively. Thank you. And our next question coming from the line of Graig Suvannavejh with Mizuho Securities. The line is open. Hey. Good morning, Sharon. Thanks for taking the question and congrats on the data. I was just curious, given how robust the outcome was in study 501, which I think is a surprise to many, positive surprise, I was wondering, with this in mind, has that in any way changed your view of expectations for study 502 and/or study 505? Again, I think that the results were just really robust. I'm just wondering if you're expecting the same in the next studies. Thanks. So I think the reason you do these studies is to see what the outcome is. We plan, just to remind you, these studies are powered to 90% to detect a 2-point difference. Obviously, in this study, we demonstrated a much larger change and thereby driving the p-values that you saw on the slides as well as the effect sizes. I think clinically meaningful is what is important. And I think that as long as we can demonstrate clinically meaningful changes, then they are successful studies. And then the robustness that we've seen here just further underscores our belief in lumateperone and the mechanism of action of this drug that has led us to believe that it would be such a good treatment for mood disorders. Thank you. Our next question coming from the line of Ashwani Verma with UBS. The line is open. Hi there. Congrats from my side as well. So two questions for me. Just in terms of the baseline for Study 501, this seems to be around 30 points, sort of somewhere in the middle of what we've seen from Rexulti and Vraylar. To what extent do you think that drove these strong results? And if you can comment on Study 502, would you be around the same baseline, you think? And then secondly, on the tremor side effect just seen in the adverse event section, that is a little bit surprising. I believe we haven't seen that before. Just curious, what are your thoughts on if there's anything specific to MDD that might be causing it, or what do you think is driving that? Thanks. So I'll start. Or Suresh, do you want to start with? Yeah. Yeah. Yeah. Go ahead. So in terms of the baseline MADRS scores, 30 is typically seen, especially when you have a baseline when you have an inclusion criteria of 24. And this is seen in most trials, anywhere ranging from 29-32. So that is not uncommon, and we also fell in the same place as other antipsychotics. In terms of your question regarding the tremor, in our previous trials in schizophrenia and bipolar depression, we did see tremor, but it did not meet the threshold of the 5%. In this study, it met. That's why we are reporting. And in the tremor, all adverse events of tremor were mild to moderate, and most of them were mild. And then all of them resolved in a very short period of time. Thank you. Our next question coming from the line of Troy Langford with TD Cowen. The line is open. Hi. Thanks for taking our question, and congrats on the impressive data. So now that we've seen the data from this first adjunctive MDD study, and we can see the robustness of the effect, do you think that the FDA would necessarily need to see a statistically significant result from the second study later this quarter to feel comfortable with the label expansion for Caplyta and MDD? Thanks for the question. I think let's wait and see. We do know the FDA looks at the totality of your data. With this data in hand and our other studies in both bipolar and studies in mixed features, I think and so with all of our previous studies, we do have a very strong package of our totality of our data. But I think let's wait and see what the data looks like in the second study, which we'll be getting pretty soon. Okay? But we are encouraged by all of this, I would tell you. I think that we do think the data is great, and we think it very much supports the use of lumateperone for the treatment for adjunctive treatment of MDD. Thank you. And our next question coming from the line of Ami Fadia with Needham & Company. The line is open. Hi. This is Poonam for Ami Fadia. Thank you for taking our question, and congratulations on the positive study. I just have two questions. Can you give us a sense of what percentage of the total prescriptions of the four currently approved antipsychotics is for MDD? And from the trial, can you discuss what prior therapies for these patients have failed and what standard of care were they on? I could not understand what you were asking. You're coming through muffled. Oh, sorry. I was asking what percentage of the total MDD patients are they getting antipsychotics today? My second question was if you can discuss what prior therapies the patients were on in the trial, the ones that failed, and what was the current standard of care that they were on in the study? Yeah. Again, I think that's a commercial question that we will address all commercial questions on upcoming earnings calls and other calls. As far as this patient population, they are not—I mean, we're treating them with our antipsychotics. They're not being treated simultaneously with another antipsychotic. So again, I'm not sure I understood your question, but maybe if then either you can rephrase it or if we wait till our earnings call, that would be great too. Okay. Thank you. I think just my second question in terms of the trial was if you know what prior therapies these patients had failed and what the standard of care was on the study along with Luma? Yeah. So yeah, we've listed that on ClinicalTrials.gov. I think they're on all the they can have been on all the approved SSRIs and SNRIs or Wellbutrin. So they're coming into the study off of any of the approved drugs. Thank you. Our next question coming from the line of Corinne Jenkins with Goldman Sachs. The line is open. Good morning. Thanks for congratulations on the data. I wanted to ask, as you think about kind of how quickly you can take these data and then get them in front of the FDA and file for approval, I guess, what steps are required post the second study readout, and how quickly do you think you can get them to the regulators? So thanks for the question and the congrats. I think we are working as hard as we can to be able to, as soon as we have that second study, drop that into an sNDA and go ahead and submit our package and obviously working on the first one right now. What we've said is that we expect a filing later this year. I would tell you, obviously, in the second half, and we would tell you later. I would probably say late this year, but I can't give you an exact month yet. Let's see how fast we can get this stuff put together. But we've said this year and later this year. Thank you. Our final question coming from the line of Joel Beatty with Baird. The line is open. Great. Congrats on the data. Two questions. First is, any difference you saw in MADRS in U.S. patients compared with ex-U.S. patients? And then the second is, were there patients with MDD with mixed features in this study? And if so, about what% and what types of analyses could we see on those? Yeah. So again, looking at differences in the different countries, I think that is a subsequent analysis. I can tell you that obviously, with this kind of effect size and this kind of point change, you are going to be successful or trending in every country you're in. So I think that expect to see robust data throughout the world. If there were sites that only had a few patients, expect to see trends. If there were countries with only a few patients, countries that have a lot of patients like the U.S., you can expect statistical significance. So I think that, again, we're very pleased that this study has really supported everything we've seen with lumateperone in other studies. As far as mixed features, we did not use scales measuring mixed features in this study. Thank you. I'm showing no further questions under here at this time. I will now turn the call back over to Dr. Sharon Mates for any closing remarks. I think that we're really, really pleased with the efficacy and safety and tolerability that we've seen in this study. And again, it is a continuation of everything that we've seen in prior studies. And with these results, as I've mentioned before, I think that we're very excited about the potential for lumateperone to help patients across broad ranges of mood disorders. So with that, I would tell you, thank you, everybody, for attention. And operator, you can disconnect, and we look forward to our next call with everybody. Thanks a lot. Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.