Juan Sanchez - Vice President, Corporate Communications and Investor Relations Sharon Mates - Chairman and Chief Executive Officer Kimberly Vanover - Vice President, Clinical Development Larry Hineline - Chief Financial Officer Allen Fienberg - Vice President, Business Development Cedric O’Gorman - Vice President, Medical Affairs Ashish Dugar - Vice President, Commercial Development Michael Halstead - Senior Vice President and General Counsel.

Adnan Butt - RBC Capital Markets Bert Hazlett - Ladenburg Bill Tanner - Guggenheim Securities Ritu Baral - Cowen.

Good morning, ladies and gentlemen and welcome to the Intra-Cellular Therapies’ Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, today’s conference call is being recorded. I would now like to turn the conference over to your host, Dr.

Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Please go ahead..

Thank you, operator. Good morning and thank you for joining us for today’s conference call. Our earnings press release, providing a corporate update and details of the company’s financial results for the quarter ending September 30, 2015 crossed the wire a short time ago. The press release is available on our website at www.intracellulartherapies.com.

Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer; Dr. Kimberly Vanover, Vice President of Clinical Development; Larry Hineline, Chief Financial Officer; Dr. Allen Fienberg, Vice President of Business Development; Dr. Cedric O’Gorman, Vice President of Medical Affairs; Dr.

Ashish Dugar, Vice President of Commercial Development; and Michael Halstead, Senior Vice President and General Counsel. As a reminder, during today’s call, we will be making certain forward-looking statements.

These statements may include statements regarding among other things, the efficacy, safety and intended utilization of the company’s product candidates, the anticipated conduct and results of future clinical trials, plans regarding regulatory filings, future research and development and possible uses of existing cash and investment resources.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risk and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our Form 10-Q for the quarter ending September 30, 2015, which is expected to be filed with the SEC later today.

You are cautioned not to place undue reliance on these forward-looking statements and the company disclaims any obligation to update such statements. I will now turn the call over to Sharon..

Thanks, Juan. Good morning, everyone and thank you for joining us on the call today. Third quarter of 2015 was an exciting quarter for ITI as we continued to make significant progress towards the development of new drugs to improve patient’s lives.

To this end, during the third quarter, we announced positive results from our first Phase 3 clinical trial for the treatment of patients with schizophrenia and we announced that we are entering a Phase 3 development program for bipolar depression.

We continued to advance our other clinical programs, including behavioral disturbances in patients with dementia. We also successfully completed a public offering, which significantly strengthened our balance sheet.

Today, I will review the progress we have made in the third quarter with ITI-007 and our clinical pipeline and will outline our upcoming activities. Kim will review the recently announced results of our first ITI-007 Phase 3 clinical trial in patients with schizophrenia and our PET study.

She will also discuss aspects of the design for our Phase 3 clinical program in bipolar depression and will provide a brief update on our ITI-007 program for the treatment of behavioral disturbances in patients with dementia, including Alzheimer’s disease.

Lastly, Larry will review our financial results, including the recent $345 million public offering that the company completed in September. After that, we will open the call for questions. Intra-Cellular Therapies’ mission is to bring new treatments to patients suffering from neuro-psychiatric and neurologic disorders.

Patients with schizophrenia, bipolar depression and dementia all have significant medical needs that are not being met with current therapies. We strive to reduce the burden on these patients and their caregivers through the continued development of innovative treatment options.

To this end, we believe that ITI-007 with its demonstrated efficacy as well as its favorable safety and tolerability profile will lead to increased medication adherence and improved patient outcomes. In September, we announced positive top line results from our Phase 3 trial of ITI-007 in patients with schizophrenia.

In this trial, once-daily ITI-007 16 milligrams dosing met the primary endpoint by demonstrating antipsychotic efficacy with statistically significant superiority over placebo as measured by the mean change from baseline on the positive and negative syndrome scale, or PANS total score.

Moreover, no dose titration was required and once-daily dosing of ITI-007 16 milligrams showed significant antipsychotic efficacy as early as week 1, which was maintained at every time point throughout the entire study.

ITI-007 16 milligrams also met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scale for severity of illness, or CGIS.

ITI-007 showed a dose-related improvement in symptoms of schizophrenia with the 40 milligram dose approximating the trajectory of improvement seen with the 16 milligram dose, but the effect with 14 milligrams did not reach statistical significance on the primary endpoint.

ITI-007 14 milligrams did demonstrate a statistically significant improvement versus placebo on the CGIS. While the PANS total score is the primary research tool used for regulatory purposes, the CGIS represents the clinicians’ real world assessment of the patients’ illness severity.

The findings from this study coupled with the findings from our prior Phase 2 clinical trial confirmed the positive results for ITI-007 16 milligrams for the treatment of schizophrenia.

Consistent with previous studies, ITI-007 had a favorable safety and tolerability profile as evidenced by motoric, metabolic and cardiovascular characteristics similar to placebo.

While most antipsychotics require titration, the efficacy and tolerability demonstrated by ITI-007 in clinical trials indicate that the drug can be safely dosed once a day for efficacy without the need for titration.

Thus, we believe an important attribute of ITI-007 is the ability for patients to receive a safe and efficacious therapeutic dose from day 1. The ITI-007 development program in schizophrenia includes a second Phase 3 trial. Clinical conduct in this second trial is ongoing and we expect top line data in mid-2016.

Our positron emission tomography, or PET studies have helped to elucidate ITI-007’s unique mechanism of action. The antipsychotic efficacy seen with ITI-007 16 milligrams has been achieved at lower D2 receptor occupancy levels, not seen with most currently approved anti-psychotics.

Kim will further describe the recently announced top line results from our PET study in patients with schizophrenia.

In conclusion, our data have shown that ITI-007 has a unique mechanism of action and treatment results and early improvement in psychotic symptoms and better social functioning without the detrimental adverse events commonly associated with existing anti-psychotics.

When taken in totality, these combined activities lead us to believe that ITI-007 is a first-in-class highly differentiated compound with broad potential for treating patients.

We will continue to present data from the Phase 3 schizophrenia program as well as further findings from our PET study at upcoming scientific and medical meetings, including the American College of Neuropsychopharmacology Annual Meeting, or ACNP later this year. In July, we announced our plans for developing ITI-007 in bipolar depression.

Our Phase 3 program consists of two multi-center randomized double-blind placebo-controlled trial. This program allows us to seek an indication in bipolar depression both as monotherapy and adjunctive therapy with one trial for each of these treatment strategies.

We continued to advance ITI-007 into a late stage development program for the behavioral disturbances in patients with dementia including Alzheimer’s disease.

We also continued to make progress in the design of clinical trials for several other programs including ITI-007 for the treatment of major depressive disorder and the preclinical development of the ITI-007 long-acting injectable program.

The third quarter also marked additional milestones for the company including the completion of the multiple Phase 1 studies of ITI-214 a phosphodiesterase type 1 or PDE1 inhibitor.

ITI-214 has demonstrated a favorable safety profile and was generally well tolerated across a broad range of doses both in healthy volunteers and in patients with schizophrenia with a pharmacokinetic profile that supports once daily dosing.

We are currently evaluating the strategy for ITI-214 for several indications including cognition in patients with Parkinson’s disease, dementia, schizophrenia and other CNS and non-CNS disorders. Lastly we ended the third quarter with $510.7 million in cash.

With these resources we plan to continue to develop the ITI-007 platform including manufacturing and the associated ITI-007 prelaunch activities. To a lesser extent, our funds will also support the clinical development of our PDE1 inhibitors and our R&D pipeline. Larry will discuss the financing when he reviews the financials for the quarter.

I would now like to turn the call over to Kim..

Thanks Sharon. I am pleased to review the top line results of the Phase 3 clinical trial of ITI-007 in patients with schizophrenia in the PET study and to provide some details of the design of our Phase 3 clinical trials in bipolar depression.

In the Phase 3 study in schizophrenia referred to as ITI-007-301 was a randomized double blind placebo controlled clinical trial in patients with an acutely exacerbated episode of schizophrenia. The trial randomized 450 patients equally across three treatment arms of ITI-007 60 milligrams, 40 milligrams or placebo.

ITI-007 60 milligrams met the primary end point by demonstrating statistically significant improvement on the PANS total score versus placebo at day 28. In this study, 60 milligrams demonstrated antipsychotic effect as early as the first week of treatment is measured by the PANS total score and the positive symptom subscale.

And this was maintained throughout the study. 60 milligrams also met the key secondary clinical end point demonstrating a statistically significant improvement versus placebo on the CGI-S.

ITI-007 60 milligrams also demonstrated a statistically significant improvement compared to placebo in social functioning as measured by the personal and social performance scale or PSP.

The PSP assesses the patient’s level of psychosocial functioning across four important social domains; socially useful activities, personal and social relationships, self-care and disturbing in aggressive behavior. We believe ITI-007 addresses a broad spectrum of symptoms that together lead to improved social function in patients with schizophrenia.

ITI-007 showed a dose related improvement in symptoms of schizophrenia with the 40 milligram dose approximating the trajectory of improvement with the 60 milligram dose. But the effect with 40 milligrams did not reach statistical significance on the primary end point.

ITI-007 40 milligrams did demonstrate a statistically significant improvement versus placebo on the CGI-S though not formally tested as the key secondary end point against placebo since this dose did not separate on the primary end point.

We are very encouraged by the safety and tolerability profile of ITI-007, which did not differ significantly from placebo. In addition, we observed high completion rates in patients treated with ITI-007. We believe this may translate into good medication adherence. Additionally, the majority of adverse events were mild in nature.

Patients on ITI-007 showed no significant differences from placebo on weight gain, on prolactin levels, on akathisia and other movement disturbances and on metabolic parameters such cholesterol, triglycerides, glucose and insulin.

These robust data show efficacy benefits early in treatment that are sustained without many of the usual side effects of existing medications for schizophrenia. The unique pharmacological profile of ITI-007 was demonstrated in our PET study in patients with schizophrenia.

In this study, ITI-007 60 milligram was associated with a mean striatal dopamine D2 receptor occupancy of approximately 40% confirming in extending previous findings from our PET study in healthy volunteers. ITI-007 has been determined to have a mechanism that differs from antipsychotic drugs that are approved and available to patients today.

ITI-007’s unique mechanism interacts at the D2 receptor as a pre-synaptic partial agonist and post-synaptic antagonist which is complemented by ITI-007’s additional pharmacology acting as a potent 5HT2A receptor antagonist, a glutamatergic modulator likely through its D1 signaling pathway and a serotonin reuptake inhibitor.

Our clinical results demonstrate that 60 milligrams can safely achieve antipsychotic efficacy with relatively low levels of D2 receptor occupancy, which likely contributes to the reduced risk of hyperprolactinemia, akathisia, EPS and other motoric side effects.

We are looking forward to the next step in our clinical development for schizophrenia including the results from our second Phase 3 trial which is currently ongoing and for which we expect results in mid-2016. We are also pursuing a program in bipolar depression. Our Phase 3 bipolar program consists of two clinical trials.

The first Phase 3 study will evaluate ITI-007 as a monotherapy and the second Phase 3 study will evaluate ITI-007 as an adjunctive therapy with lithium or valproate. The primary end point for both studies will be the Montgomery-Asberg depression rating scale or MADRA following six weeks of treatment.

The MADRAs is a ten item scale designed to measure the overall severity of depressive symptoms and has been used as a primary tool for registration trials supporting drug approval in unipolar and bipolar depression. Patients with a major depressive episode associated with bipolar 1 or bipolar 2 disorder are planned to be enrolled in each trial.

And we will be evaluating once daily doses of ITI-007 at 40 milligrams and 60 milligrams. We have commenced startup activities and we are on track with the timelines for this program. This allows us to seek an indication in bipolar depression as both monotherapy and adjunctive therapy with one trial for each of these treatment strategies.

We continue to make progress on our clinical program in behavioral disturbances associated with dementia including Alzheimer’s disease.

In addition to the hallmark cognitive deficit patients with dementia also suffer from agitation, heightened aggression, depression, sleep disorders, sundowning and Psychose, behaviors which often lead to early institutionalization.

We believe low doses of ITI-007 have the potential to reduce these behavioral disturbances with a favorable safety profile that does not increase the risk of cardiovascular event or falls due to motor impairment. We expect to initiate clinical studies in this program by the end of this year or in the first half of 2016.

The third quarter has been a very productive time for the clinical development team at Intra-Cellular Therapies. We look forward to making further strides in the development of treatments for schizophrenia, bipolar depression and other CNS disorders. I will now turn the call to Larry who will review the financial results for the third quarter..

Thanks Kim. I will be reviewing our financial results for the quarter ending September 30, 2015 and provide an overview of the expectations for the use of our cash and investments, including the recent offering of our common stock that raised $345 million and net proceeds of approximately $327.4 million.

The net loss for the third quarter of 2015 was $32.2 million compared with the net loss of $6.4 million for the third quarter of 2014. Basic and diluted net loss was $0.91 per share for the third quarter of 2015 compared to a basic and diluted net loss of $0.22 per share for the same period in 2014.

R&D expenses for the third quarter of 2015 were $28.5 million compared to $4.0 million for the third quarter of 2014. The increase in R&D cost year-over-year is primarily due to cost associated with the Phase 3 clinical development program for ITI-007 in schizophrenia, which was initiated in late 2014.

G&A expenses were $3.9 million for the third quarter of 2015 compared to $2.6 million for the same period in 2014. The increase in G&A expenses is primarily the result of higher stock-based compensation expense and to a lesser extent salaries, professional fees and cost due to the activities associated with being a public company.

Cash and investments totaled $510.7 million as of September 30, 2015 compared to $129.6 million as of December 31, 2014. On September 28, 2015, the company completed an underwritten public offering of its common stock for gross proceeds of approximately $345 million and net proceeds of approximately $327.4 million.

We expect that existing cash and investments will be dedicated primarily to the ITI-007 program, including clinical trials of ITI-007 in schizophrenia, bipolar disorder, behavioral disturbances in dementia, depressive disorders and related clinical and non-clinical activities, ITI-007 pre-launch and initial launch efforts and non-clinical activities, including manufacturing.

To a lesser extent, funds will be used for other clinical and preclinical programs, including the company’s phosphodiesterase, PDE development activities.

With that operator, could you please open the line for questions?.

Yes, sir. [Operator Instructions] And our first question comes from the line of Adnan Butt of RBC Capital Markets. Your line is open. Please go ahead..

Yes, good morning. Thanks for the question.

So, first on the first Phase 3 schizophrenia study, when do we expect to present more details and where? And then secondly on the bipolar study, should we sort of think of it as a two-year timeline from start to finish once it begins? And what’s 007 providing here is it another mechanism or do you foresee differences versus other agents used? Thanks..

I will start and then I will turn it over to Kim. Thanks, Adnan. This is Sharon. So, first, we will be rolling out more data at the different upcoming conferences this year.

The last conference and the upcoming medical conference that talks about schizophrenia is in December and it’s at the ACNP, or American College of Neuropharmacology and we will be at that meeting and we will be presenting more data there.

Next year, there are a few conferences, including SIRS, the Society for International Research in Schizophrenia and then there are a couple of other mets in April and then there are several meetings after that as well. And we hope to be giving more data at each of those meetings.

On the bipolar study, you are right in your terms of thinking, we should be thinking about two years. Of course, that’s highly dependent upon enrollment rate. So, if we are fortunate and can enroll faster than we are projecting, then it will be sooner. We have used a very conservative estimate. So, right now, we don’t expect it would be longer.

And then as far as mechanism and why we think that we can be a unique treatment in bipolar depression, I will turn that over to Kim..

Hi. With ITI-007 in schizophrenia, we have really seen a broad utility across a wide range of symptoms and we think this will translate really well to the bipolar depression patients. We believe ITI-007 will reduce depression and improve the social functioning in these patients.

ITI-007 also has a favorable side effect profile without the side effects that are commonly seen with antipsychotics. And we believe this will translate to good medication adherence for this patient population..

Okay. Thanks, Sharon and thanks, Kim..

Thank you. Our next question comes from the line of Bert Hazlett of Ladenburg. Your line is open. Please go ahead..

Thank you. Thanks for taking the question. Just wanted to first is on the second Phase 3, I guess just using the first Phase 3 as a proxy, you took a look at CGI as a secondary endpoint as well as the psychosocial functioning.

What important secondary measures will be considered in the second Phase 3 that’s upcoming in mid 2016? Then secondly, mid 2016 timing, given the success, is there any potential upside for that timing? And then third and sort of stack them all up here, but the depression or depressive disorders indications that seems to be I guess at the end of the line in terms of the first set of indications, why is that and when might we see you spool up that effort? Thanks..

Hi, Bert. This is Sharon. I am not sure we understood the last part of your questions. And very cleverly, you have hit three questions into one question. So, just I will start and again turn it over to Kim afterwards, but just as an overall, the second Phase 3 is designed the same as the first Phase 3.

So, we have the same outcomes and yes, we are looking at CGI, we are looking at psychosocial functioning. I don’t know, Kim, if you want to add anything to that. Okay, then I will turn it over to you..

No, no, I think that’s fine. That’s right. I think that you can anticipate to see the same outcomes in the second Phase 3 trial and we are on track to be reporting out those data mid next year..

And I think that answers the second part of your question, but I wasn’t sure, I quite got it. And then the third part on depressive disorders is that’s the end of the line, I don’t really understand what that means.

You want to just elaborate a little bit?.

Sure. I guess major depressive disorders, I know obviously bipolar depression is something you are looking at now, but maybe additional indications in terms of MDD or when will that spool up.

You have talked about the bipolar and the behavioral disturbances in dementia, but when will we see spool up the depressive disorders’ effort?.

So, right now, we are looking at sometime probably not before late ‘16. We are still working on designs of those studies. So, we will update you as soon as we have the studies ready to go..

Okay, thank you..

Thank you. Our next question comes from the line of Seamus Fernandez of Leerink. Your line is open. Please go ahead..

Hi, good morning. This is Lee on behalf of Seamus. Thanks for the questions. Just a couple of quick ones.

First, could you comment on the bipolar mania or opportunity and development timeline in that indication now that it’s soon to be de-prioritized relative to bipolar depression? And then secondly, could you share some specifics on your strategy and plan for ITI-214, the PDE1 inhibitor that you licensed from Takeda? Thank you..

Great. So, this is Sharon again and I will start with the mania. Okay. So, first let’s just clarify, I guess we have a little difference of opinion here on what your question was, but so the ITI-007 platform is not partnered with anybody at this point.

Intra-Cellular Therapies is developing ITI-007 and someone here thought you said that we licensed it from Takeda, but we didn’t....

214 license from Takeda. I am just correcting the question because we didn’t license 214..

Okay, alright. So now, if I could remember what the question was the bipolar mania opportunity, okay. So we have not de-prioritized bipolar mania if that – so you – just to remind everybody to be – to meet the criterion of bipolar disorder you have to have exhibited a mania event and then a depressive event.

So otherwise, you call it unipolar if all you have is the depression events. So bipolar mania is treated with the antipsychotics and there are several products available to patients where there are mania episodes.

The depressive episodes which become more frequent and are longer in duration over time do not have as much opportunity for treatment of a present antipsychotics. There are only a few that are approved in fact there are three approved antipsychotics and only two of those are really used.

So we think that there is much – there is an unmet medical need in the treatment of bipolar depression. And we think for all the reasons we have been telling you about on this call today that ITI-007 is uniquely positioned to be able to help patients in this – with this disorder.

We think also that a big component of treating both schizophrenia and bipolar disorder and major depressive disorder is that patients don’t stay on their medications and they don’t stay on the medications in large part because they don’t like the way they feel on the medications.

And we believe that with the safety and tolerability profile of ITI-007 we believe that they may in fact stay on their medications and thus this would benefit patients greatly.

Do you want to add anything Kim?.

No, I think that’s right, we think this is a large unmet need and we don’t say we have a de-prioritized mania, but we prioritized that’s going after depression because we think that that represents a larger need at this point..

Right. And you are correct. Thank you for reminding me. We have not de-prioritized mania. And then to get to the 214, we – 214 was discovered, developed in-house, it is a very novel target, novel molecular structures that we have developed to treat many CNS disorders that hit this target.

So we are developing 214, we had – we licensed it out, not in, to Takeda, as you all know last year we and Takeda agreed to terminate that partnership and they transferred back 214 in the back up molecules to us and have just finished the transfer of the IND as we said in our last call.

And that we are looking – the good news is they are just like with ITI-007 there are many indications that we believe ITI-214 and related compounds would be beneficial for and so we are still sorting that out within the CNS there are – there is cognition not only in schizophrenia, but also in Parkinson’s disease and in Alzheimer’s disease.

And there are several other indications within the CNS. And then there are some non-CNS indications that we are in the midst of some preclinical studies on as well. So I think that we are prioritizing the indications that we will be looking at with 214. And as soon as we have that done, we will let you guys know..

Perfect. Thank you and apologies for the confusion..

Thank you. Our next question comes from the line of Bill Tanner of Guggenheim Securities. Your line is open. Please go ahead..

Thanks for taking the questions.

Sharon I just had one question on the use of proceeds you talked about to fund the clinical development primarily of 007, maybe some of the manufacturing costs and then prelaunch costs, so understanding it’s still perhaps better say flux is wondering if you could maybe give us some details on from a commercialization perspective what is feasible for Intra-Cellular to undertake.

And then obviously with multiple potentially multiple indications for 007, how do you see the synergies or are there being synergies or overlap assuming that you have the drug approved for things other than schizophrenia?.

So thanks Bill. This is Sharon and I will again start and then ask if anyone else wanted to chime in. So first from a commercialization prospect, we do see that we can take ITI-007 to market on our own. We believe that be psychiatry market and the neurology market are we can well serve these markets with not all that many reps.

I think as we go out and extend into the primary care market, I think there a lot of opportunities for us to not only market it on our own, but to have partnerships in that arena as well. I think does that answer your question..

Yes.

And I mean I guess just as you think about schizophrenia bipolar depression and behavioral disturbances, just wondering I guess from venn diagram perspective what’s the overall app there in terms of the call points just thinking about…?.

There is large overlap into – for the prescribers, they are psychiatry and neurology. And then primary care physicians more and more are prescribing these drugs as well, but the bulk of the patient visits are still in psychiatry and neurology..

Got it. Okay. Thanks very much..

Thank you. [Operator Instructions] Our next question comes from the line of Ritu Baral of Cowen. Your line is open. Please go ahead..

Hi everyone. Thanks for taking the question.

Sharon, did you present any additional adverse events or tolerability data at the CNS Summit when you presented, I understand there may have been a little more detail on sedation rates, could you go over that for us?.

Sure. Hi Ritu, so no, we didn’t have than I am aware of anymore data on anything and I don’t think there is anymore data on adverse events and we already told you. So I mean it’s a safe drug. So I don’t think there was anything else. And no our next data is really going to be efficacy data expanded will be at the next upcoming medical meetings..

Got it.

And then digging down a little further from Adnan’s question from the very beginning, as you look at the different mechanisms that 007 has, what mechanisms do you think relate most closely to the pathology of either bipolar depression or major depressive disorders which one of those pathways is most important as you look at this program?.

I will ask Kim to answer that one..

Hi, Ritu. So I think that it’s really the exciting part with ITI-007 is really its unique pharmacological profile and it has different neurobiological pathways that are acting synergistically in order to really improve a wide array of symptoms without the side effects that we are seeing with many of the other drugs.

So for example the serotonin reuptake inhibition of ITI-007 is the well known antidepressant mechanisms. But the 5HT2A antagonism combined with that provides us with a more robust synergistic effect in the serotonergic system.

And then that couples with the dopaminergic modulation and the indirect effects in the glutamatergic system that we think comes downstream from the D1 receptor signaling pathways really acts together to reduce a broad array of symptoms?.

Got it. That’s helpful. And Sharon, remember last quarter, you promised me more detail on the Alzheimer’s behavioral program, so I want to ask again.

Any additional detail on those on which indication you would rather go after in the potential size of the first Phase 2 studies there?.

So, we will soon be telling you the design of those studies. I think you can appreciate that there are a lot of reasons. We have a policy of before we only once we are posting a study on clinicaltrials.gov do we give out the entire design of the study.

So, I think that while I would love to be able to tell you that the entire design, I think we are going to just hold off just a little bit longer until we are ready to post it on clinicaltrials.gov..

Got it. And my last question is just your general expectations around the negative symptom data that your next Phase 3 in schizophrenia is able to produce.

Do you think that six weeks of treatment is long enough to really show more preparation to reach statistical significance and how does the fact that the in-patient study sort of contribute to the magnitude of what it’s possible to generate in the study?.

Hey, thanks for that question. So, I will start by saying that we believe that ITI-007 is not only improving the positive symptoms, it’s including – it is improving positive symptoms than negative symptoms. The general cycle pathology, the social functions, they have a better sense of self well-being being able we hope to integrate into society.

I think the study designs are not specific to negative symptoms. We do. As we have described before, we do improve their negative symptoms, but it’s the overall improvement in the patient’s lives and I am going to give it to Kim to talk a little bit more detail about it..

Right. And I would just reiterate that these studies are not designed to measure statistical significance on negative symptoms per se. This is an acute patient population. On the other hand, qualitatively as we have demonstrated in our previous trials that we would anticipate being able to see an improvement in negative symptoms qualitatively.

And in comparison to Risperidone as we showed in our Phase 2 trials that there are some negative symptoms that really are worsened by Risperidone that ITI-007 did not worsened and there are negative symptoms that are actually improved with ITI-007 that you don’t see the improvement with other – with Risperidone or other antipsychotics.

So, qualitatively, we think that we are approaching the broad array of symptoms with ITI-007 in a different way than the other antipsychotics and that this is really translating to the overall benefit on improved psychosocial functioning that we have demonstrated in our Phase 3 trial. Thanks..

Great. Thanks for taking the questions..

Thank you. [Operator Instructions] And I am showing no further questions. I would like to turn the conference back over to Dr. Sharon Mates for any closing remarks..

Thank you and thanks everyone for your questions. And in closing, the third quarter was an exciting one for ITI. We believe ITI-007 represents a significant advancement in the treatment of schizophrenia and other neuropsychiatric and neurological disorders.

Our positive clinical data coupled with our strong financial positions brings us closer to realizing our mission of developing innovative treatments that can have a meaningful impact on the lives of patients and their caregivers. Thank you for your participation on our call and operator, you may now disconnect..

Ladies and gentlemen, thank you for your participation. This does conclude the program and you may all disconnect. Have a great rest of your day..