Intra-Cellular Therapies - Q3 2020
November 9, 2020
Transcript
Speaker 0
Good morning, ladies and gentlemen, and welcome to the Intracellular Therapies Third Quarter ended September 30, 2020 Financial Results Conference Call. At this time, all participant lines are in a listen only mode. After the speakers presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I'd now like to turn the conference over to your host, Doctor.
Juan Sanchez, Vice President, Corporate Communications And Investor Relations. Please go ahead.
Speaker 1
Thank you, operator. Good morning and thank you all 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 third quarter ended September 30, 2020 crossed the wire short time ago. Is available on our website at intracellulartherapies.com. Joining me on the call today are Doctor.
Sharon Mates, Chairman and Chief Executive Officer Doctor. Suresh Dogman Chief Medical Officer Mark Newman, Chief Commercial Officer Larry Highland, Chief Financial Officer and Michael Hostel's General Counsel. As a reminder, during today's call, we will be making certain forward looking statements. These statements might include statements regarding among other things, the efficacy, safety and intended utilization of the company's product development candidate our clinical and non clinical plans, our plans to present or report additional data, the anticipated conduct and results of ongoing and future clinical files planned regarding regulatory filings, future research and development, our plans and expectations regarding the commercialization of KAPLITA, the potential impact of the COVID-nineteen pandemic on our business 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 risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.
These in our periodic filings made with the Securities And Exchange Commission, including our quarterly and annual reports. You're 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.
Speaker 2
Thanks, Juan. Good morning, everyone. We hope you have remained safe and healthy during this time of COVID. Since we last spoke to you in August, we have made substantial progress in executing our commercial objectives. And our clinical and preclinical development programs.
I am pleased to update you on this progress today. Following my remarks, Mark Newman, our Chief Commercial Officer, will provide an overview of our commercial activities. Sresh Durgham, our Chief Medical Officer, will discuss our clinical development programs and Larry Heinelein, our CFO, will provide details of our 3rd quarter financials. We continue to operate in an environment impacted by COVID. I am particularly proud of our team's resilience, focus an innovative spirit in supporting our growing number of Kepleiter prescribers and patients during these unprecedented times.
We are conditioners on their patients' experience. We are confident and expect continued prescription growth and are actively preparing for Lumateperone label expansion with the second indication in bipolar depression. We have also continued to advance our clinical development programs and increased our strong financial position. During the third quarter, we reported positive top line results from Study 4 2 evaluating Lumateperone as an adjunctive treatment to mood stabilizers in patients with bipolar depression. With these positive results and the positive results of our monotherapy study, Study 404, we are preparing this submission to the FDA of our supplemental new drug location for the treatment of bipolar depression in patients with bipolar 1 or bipolar 2 disorder treated as monotherapy or as adjunctive therapy to lithium or voproate.
We expect to complete this submission in the near term and would anticipate an FDA target action date in the second half of twenty twenty one. We believe Lumateperone has the potential to become a major product in bipolar depression There are over 11,000,000 adult Americans living with bipolar disorder with only a few approved therapies for bipolar depression. There is an important need for safe and well tolerated alternative. Lumateperone has the potential to be the only approved treatment for a broad population which includes patients with either bipolar 1 or bipolar 2 disorder as a monotherapy or as adjunctive treatment to move stabilizers. The benefit of Lumateperone as a broad treatment for bipolar depression is further enhanced by its efficacy and favorable safety and tolerability profile.
Rates of anesthesia, breathlessness, extrapyramidal symptoms and changes in weight and metabolic parameters in our bipolar studies were similar to Placebo, consistent with the safety profile demonstrated in all other Lumateperone studies. We have designed a broad clinical development program as we believe Lumateperone will become a major player in the treatment of depressive disorders, including bipolar depression, major depressive disorder or MDD and other depressive disorders. Lumateperone has shown its antidepressant effect throughout our development programs. Lumateperone has generated positive outcomes in 2 large Phase III bipolar depression studies, In addition, antidepressant effects were seen in a subgroup of patients with comorbid depression in our short term schizophrenia studies as well as in our in patients with comorbid depression, regardless of whether they were receiving any depressants or not. This provides further support for our major depressive disorder development programs.
Today, Doctor. Suresh Sturgham, our Chief Medical Officer, will outline our plans to advance Lumateperone in MDD, including the changes we have made to study 403 and our plans for our Phase III studies for Lumateperone as an adjunctive therapy in patients with MDD. Following our positive results in the recently completed Study 4 2, we have amended Study 403 to expand the opportunity for Lumateperone. In a post hoc analysis of Study 404, in a subgroup of patients with bipolar depression with mixed features, Lumateperone 42 milligrams had a statistically significant improvement from baseline on the Madras Total Score versus Placebo. Study 403 now evaluates patients with mixed features who have MDD or bipolar depression.
About a third of patients with MDD or bipolar depression exhibit mix features. These patients respond poorly to antidepressants have greater symptom severity, have a higher risk of suicide attempts and experience severe illness with more comorbidities. Suresh will further explain the unmet need in this patient population. This has been a very busy quarter and we have several other clinical updates. That following a recent successful Type C meeting with the FDA, we will commence early clinical development of our long acting injectable, a subcutaneous the subcutaneous formulation of lumateperone later this year.
Given the safety and efficacy profile of lumateperone, we believe this formulation can be an important option for the treatment of substance use disorders is advancing. Following a recent successful pre IND meeting with the FDA, we expect to initiate in late 2020 or early 2021. We've received a grant from the National Institute on Drug Abuse as part of the NIH helping to end addiction long term initiative or heal to support the early clinical development of ITI-three thirty three for the treatment of opioid use disorder. Further details will be provided Our company is in a strong position. Keplyta is approved for the treatment of schizophrenia in adults, and we have an experienced commercial organization supporting Keplyta.
We expect to soon submit an sNDA for Lumateperone for a second major indication by Polar Depression expanding the market opportunity for lumateperone and we have a broad development plan for lumateperone in major depressive disorder and other major neuropsychiatric conditions. We are well capitalized and we ended the quarter with over $723,000,000 in cash and investments I'll now turn the call over to Mark. Mark?
Speaker 3
Thank you, Sharon and good morning, everyone. I appreciate the opportunity to expand on Sharon's remarks regarding our commercialization progress. We continue to be very pleased with the strong commercial execution of our and the performance of CAPLIDA in the marketplace, despite continued COVID related disruptions to the healthcare system. As COVID conditions remain fluid throughout the U. S, we continue to innovate, adapt and execute our commercialization strategy deploying a hybrid model of in person and virtual sales force and medical education capabilities to support CAPITAL's ongoing launch efforts.
We have also enhanced our digital marketing initiatives, effectively expanding our target audience reach and optimizing our engagements with physicians and consumers. Kepleta's level of awareness, trial and usage has grown significantly over the 1st 6 months of launch, and this is reflected in our recent prescription performance. During the third quarter, Caplight is new and total prescriptions grew by 2 29% and 2 79%, respectively, relative to Q2 during a time period when the overall antipsychotic market was essentially flat due to by physician feedback that patient experience has been highly prescribers of Kepalida rate overall drug performance higher than other branded antipsychotics. They highlight the efficacy and favorable metabolic weight and movement disorder profile, the ease of reaching a therapeutic dose with no need Keplyta is performing in the real world as we expected based on the clinical trial results. Keplyta's market access position continues to be strong.
Payer access for Kapalida remains highly favorable and on track with our previously stated expectations. We believe that the strong having greater than 95% access in both channels is a contributing factor driving physician confidence when choosing to prescribe Keplyta for their patients. In addition to updating perspective on the exciting potential opportunity for Lumateperone in bipolar depression. We believe Lumateperone has the characteristic to become a market leader in this multibillion dollar indication and we are laser focused on preparing to achieve this objective. According to the National Institute of Mental Health, there are about 11 million people living with bipolar disorder.
On an annual basis, bipolar disorder affects about 6,000,000 patients per year. Depression with few approved treatment options for this underserved patient population. The commercial success of recent branded entrants highlights this medical need and we expect the potential introduction of lumateperone to continue to expand this market. We also believe that Lumateperone has demonstrated a highly patients with either bipolar 1 or bipolar 2 disorder and as an adjunctive treatment to mood stabilizers or as monotherapy. We look forward to the potential for and we will continue to we are encouraged by our launch performance progress to date amidst the market condition challenges presented by COVID, We believe our launch fundamentals are well established, giving us We are pleased with our our increased reach supported by our comprehensive medical education programs, our real progress direct to consumer advertising campaign and Caplida's strong market access coverage.
We believe Caplida will continue on the path to become the leading choice for healthcare providers treating adults living with schizophrenia and are excited about the potential of lumateperone in bipolar 1 and bipolar 2 depression. I'd now like to hand the call over to Suresh. Suresh?
Speaker 4
An overview of our regulatory and research and development plans. Our team has been working diligently preparing the submission for our supplemental NDA for the treatment of bipolar depression in patients with bipolar or bipolar disorder as monotherapy and adjunctive therapy. I'm happy to share our plans to develop lumateperone for the treatment of other mood disorders. We are expanding our program to address millions of patients suffering from mood disorders for which there still is a need for safe and effective treatments. Let me start with our Phase III program in major depressive disorder.
We have commenced our Phase III clinical program evaluating limited around 42 milligrams as an adjunct to treatment to antidepressants for major depressive disorder. Clinical conduct in 2 Phase III studies will begin in 2021. Major depressive disorder affects to 10 to 15% of U. S. Population every year.
The response rates to the first pharmacological intervention is 47%, meaning over 50% of patients are candidates for either adjunctive or switching treatment strategies. Let me continue with our plans to study lumateperol in patients with major depressive disorder and bipolar depression with mixed features in Study 403. Patients with either unipolar, also known as major depressive disorder or bipolar disorder, can exhibit manic symptoms that are below the clinical threshold for mania or hypomania during their depressive episodes. These patients respond poorly to antidepressants have great symptom severity, have higher risk for suicide attempts and experienced severe illness with more comorbidities. The diagnostic statistical manual of mental disorders or DSM5, acknowledges this reality and incorporates a mix features specifier to better characterize these patients.
The number of patients with either unipolar or bipolar depression presenting clinically with mixed features is significant There are approximately 17,000,000 patients experiencing a major episode each year in the U. S. With about a third of these episodes being accompanied by mixed features. Importantly, mixed features associated with MDD represent an important risk factor the importance of identifying the presence of this pacifier to monitor patient's treatment. Bipolar disorder is also highly prevalent psychiatric condition, affecting approximately 11,000,000 Americans, about a third of patients with bipolar depression are estimated to have mixed features.
There are no drugs approved for either MDD with mixed features or bipolar depression with mixed features. Lumetric colon has shown its anti depressant effect in 2 Phase III bipolar depression studies as well as in patients with co morbid depression in our schizophrenia program. Importantly, in Study 404, our global phase 3 study bipolar depression. A post hoc analysis showed lower teprotone was effective in a subset of patients with mixed features with a P value of 0.003. We will be presenting these data at future medical meetings.
We have amended Study 40three to study limit patients by Polar Depression and MDD with mid speeches. This global study evaluates leptron 40 two milligrams as monotherapy versus placebo and the primary endpoint is change from baseline on Madra's total score at week 6. Sharon has discussed the progress regarding our early stage programs We look forward to continue to update you on our future developments. I will now turn the call over to Larry. Larry?
Speaker 5
Thanks, Turesh. I will be reviewing our financial results for the quarter ending September 30, 2020. We recorded net product sales capitalized for the third quarter of 2020 of approximately $7,400,000. No net product sales were reported in the same period of 2019. Research and development expenses for the third quarter of 2020 were $10,300,000 compared to $21,300,000 for the third quarter of 2019.
The $11,000,000 decrease is due primarily to a decrease of approximately $6,200,000 of lumateperone clinical and non clinical costs a decrease of approximately $2,900,000 in research manufacturing costs and overhead, a decrease of $2,600,000 for other projects, and is were $52,500,000 for the third quarter of 2020 compared to $15,000,000 for the same period in Selling expenses were $38,300,000 for the 3 month period ended September 30, 2020, as compared to pre commercialization expenses of $6,400,000 in the same period in 2019 This increase in selling related expenses is primarily due to an increase in sales related labor expenses
Speaker 6
of 15.4
Speaker 5
and commercialization and marketing expenses of $15,200,000. General and administrative expenses were $14,000,000 in the 3 month period ended September 30, 2020 as compared to $8,600,000 for the same period in 2019.
Speaker 3
This increase is primarily due
Speaker 5
to increased information technology costs of $2,400,000, professional fees of $1,400,000 and stock compensation expense of $1,400,000. Cash, cash equivalents, restricted cash and investment securities totaled $723,300,000 at September 30, 2020 compared to $224,000,000 at December 31, 2019. In September 2020, we completed a public offering resulting in net proceeds to the company of approximately $358,000,000 from the sale of 12,700,000 shares of our common stock. This concludes our prepared remarks. Operator, could you please open
Speaker 0
you. Our first question comes from the line of Jessica Fye with JPMorgan. Your line is now open.
Speaker 7
Hey, there. Good morning. Thanks so much for taking my questions. Maybe first, was there any changes to the amount inventory in the channel at the end of the third quarter relative to the end of the second quarter?
Speaker 2
Hi, Jess. This is Sharon. I'm going to ask Larry to take that.
Speaker 5
When you mean changes in inventory, you mean quantities?
Speaker 2
In the channel, yes.
Speaker 7
Does the amount of inventory held by wholesalers any different at the end of 3Q relative to 2Q?
Speaker 2
Yes. Let me just remind you that this is a business that it's unlike many years ago where there was a lot of stocking. There isn't stocking going on in this class. We have movement of product that happens very rapidly, within 24 hours usually. So it's not an inventory laden product.
At this point in time, the wholesalers actually are able to move product extremely efficiently.
Speaker 5
And I'll add to what Sharon is saying. As we're increasing sales, we're increasing inventory and that goes along with the sort of just in time inventory system that we're seeing. So, as sales increase, the inventory in the channel obviously will increase.
Speaker 7
Okay, makes sense. So it looks like gross to nets were fairly modest in the third quarter. And I'm wondering, is this average net selling price, you're seeing a good run rate to think about going forward, or are there other swing factors that could cause it to differ in subsequent quarters, in particular, I'm just trying to think ahead to 2021 and if we should anticipate any variability in quarterly growth to nets? Looking ahead?
Speaker 5
As you know, we've never really commented on gross to net and gross to net is, as you know, dependent upon several factors, some of which is product mix and the like. So, and you're seeing it from I'm assuming comparing scripts to our revenue. And so as we're maturing into in our sales and our product mix, you'll see changes, but we're not an outlier with regards to other companies that are in our same same position in our evolution. So, I really can't comment too much on the changes of gross to net as you see them. But I can say that they're not an outlier and they're reasonable.
Speaker 7
Okay. Just think that how some companies see a little bit more of an act, in Part D in the 1st part of the calendar year relative to later in the year. So I guess we'll keep an eye out on that. Maybe switching to study 403, just want to make sure I understand changes here. So these patients can have either MDD or bipolar depression.
They all need to have mixed features now. Is that correct?
Speaker 2
I'll ask Suresh to answer that.
Speaker 8
Yes. Hi. This is,
Speaker 4
good morning. The 403 has been amended to include patients both with major depressive disorder and bipolar depression. And those patients will exclusively have mixed features in this new amendment.
Speaker 7
Okay. And when you say a third of patients have mixed features between MDD and bipolar depression, is that proportion the same in each respective group? Is the 3rd in MDD and the 3rd in bipolar depression?
Speaker 4
Yes. In terms of the literature, there is varying
Speaker 9
willing
Speaker 4
ranges. And a third would a reasonable estimate on equity conservative estimate both for major depressive disorder and for bipolar depression. You will see a mix is about a third in both populations.
Speaker 0
Thank you. Our next question comes from the line of Charles Duncan with Cantor Fitzgerald. Your line is now open.
Speaker 9
Hi. This is Pete Stavropoulos on for Charles. Congratulations on the quarter.
Speaker 2
Thank you.
Speaker 9
Yes. I was just wondering, from your perspective, are there any specific analogs that can sort of help us think through the ramp rate. And ultimately, the time it takes to develop the traction you're anticipating for Lumateperone. Or calculated?
Speaker 2
I don't know, Mark, do you want to take that or would you like me to?
Speaker 3
Yes. No, I can make a couple of comments, Sharon, and you can add to it if you'd like. Analogs are that we've been operating under since the beginning of the launch. I would say, when we look at the various, recent brand and I say recent over the past 5 to 7 years branded antipsychotics. Part of the challenge in an analog is many of the products launched with multiple indications.
Whereas we're launching with just a schizophrenia indication. So we look we try to triangulate and look at a variety of the different branded antipsychotic uptakes and then do some adjustments based on some of the COVID related disruptions that we've mentioned. And overall, I would say that when we look at that, we are very pleased with both the commercial execution that we've been able to deliver during this time as well as the uptake trajectory and the consistency of the growth that we've seen week over week in prescriptions, and as we mentioned in the quarter over quarter growth. So, we're pleased with where we are. And we'll have to see as time goes on with COVID.
We believe we can operate very effectively in this environment. And adapt as we need to. And then as the COVID period passes and we get back to a new normal, we would look for continued acceleration in prescription. So Sharon, I don't know if you want to add anything to that.
Speaker 2
I have nothing to add. Okay.
Speaker 9
Thank you. Very helpful. One more question. With the SNDA filing in the near future for BPDBPD, what should we think about how the current commercial organization could be leveraged and what needs to be put in place as you address the new indication, if anything.
Speaker 2
So, Mark, do you want to take that one too?
Speaker 3
Yes, sure. I think the biggest area would be in the area of our sales force as we think about the opportunity in bipolar depression. The good news for us is that our current target audience of 23,000 physicians that represent opportunity in schizophrenia. Virtually all of those 23,000 also treat patients with bipolar depression. So we will be able to leverage our existing footprint our existing Salesforce.
However, as you've heard, some of the prevalence numbers, the prevalence of bipolar depression is significantly higher than schizophrenia. So the patient numbers are very high, much higher than schizophrenia. And therefore, the physicians target audience will be larger as well. So there is another subset of physicians who treat bipolar depression patients in significant numbers who don't currently treat schizophrenia patients. And so that would be the physician subset that we would look to expand our sales force.
We're in the middle of doing that work right now. We don't have specific numbers for you, but we would expect to expand our sales force in order to ensure that we have sufficient coverage to get to the opportunity area of expansion for the organization. Now as we do that, we also have to bear in mind some of the changes to that COVID has brought on and some of the permanent changes that we think will take place in terms of virtual engagement physicians and their preference for virtual engagement. And we're factoring all of that into our final decisions about the magnitude of the expansion of the sales force that we would have.
Speaker 0
Our next question comes from the line of Sumant Shuman Kulkarni with Canaccord. Your line is now open.
Speaker 6
Good morning. Thanks for taking my question. We know you've spoken about newer formulations of lumateperone potentially for MDD, but do any of the planned trials involve a new formulation and does the monotherapy trial specifically evaluate the potential for lumateperone as a rapid acting product for MDD?
Speaker 2
Suresh, would you like to take that or you want me to?
Speaker 5
Yes, I can. The
Speaker 4
MDD programs are being studied with Lumateperone. Objective treatment program is going to be studied with lumetoparone. And we will update you on the formulations
Speaker 3
Got it. And then
Speaker 6
on the commercial side, a question for Mark, I'm sorry if I missed this, but do you now that you're into the launch for a few months, do you have any better sense of how many patients were on how many drugs before cycling through to lumateperone for schizophrenia or cap later?
Speaker 3
Yeah. Thanks, Simon. As you know, this is a category and a therapeutic area that it has as its hallmark significant cycling through various antipsychotics by patients because of in antipsychotics, whether it's on the efficacy side or on the safety and tolerability side. And what we're seeing in terms of the patients that we are sourcing for KepalaIDA is really across the board. We are seeing initial starts, new patient starts for, keplyta, as well as those patients that have been on multiple antipsychotics.
So, I would say, the vast majority of patients living with schizophrenia have been on multiple antipsychotics, 2, 3, 4 antipsychotics. And this is really where the the most significant opportunity for a switch to KEMPLYDA exists. So, I'm not sure if that answers your question, Sumant, specifically, but I guess what I would say is we're seeing patients being sourced across the board, whether they've been on 1 antipsychotic, 2 antipsychotics, 3 antipsychotics, as well as some patients if their insurance allows for initial therapy following diagnosis as well.
Speaker 2
Thank
Speaker 0
you. Our next question comes from the line of Umer Raffat with Evercore. Your line is now open.
Speaker 8
Hi, this is Paul. Thanks for taking our questions. We have 2 if we may. And first, on the patent status, how should we think about the CABLADA exclusivity given the orange book patents on the salt patent on the salt crystal form has a 2029 expiry. And how important should we think about the method of use patents and long acting injectable formulation in the life cycle management.
The second question, if we may, is on the Study 43 with the amendment We're curious, given the primary endpoint is still meta as change at week 6, it's a depression rating scale. How should we think about the efficacy measure for the manic symptoms? Thanks a lot.
Speaker 2
Great. Hi, Bo. This is Sharon, and I'll take the first part about our patents and I'll ask Suresh to address the second part about, the Madras and how you're going to measure and what you're going to use for the mania portion. So first, let me just start with an overall statement about we believe we have a very strong patent portfolio that we expect will protect Lumateperone into the mid 2030s. We have multiple orange book listed patents with expirations ranging from 2028 through out to 2039.
In addition, as you know, we have the option to select 1 of the earlier expiring patents for extension to the mid 2030s. We also expect to list additional patents in the orange book following approval of Lumateperone for bipolar. That will run well into the 2030s. So I would not focus on the one patent that you did focus on, I don't think that's the right place to be. Our patents include coverage of any pharmaceutical composition, containing the active ingredient Lumateperone.
I cover use of Lumateperone to treat schizophrenia and bipolar following its approval. Lumateperone in various dosage forms, including the 42 milligram dose, Lumateperone crystals, And so we believe that our position is extremely strong and that generics cannot avoid using the approved drug substance since the approved indication or the approved dose. So we believe these patents are not readily circumventable. So I think that that's really the answer to your question. And then Suresh, would you like to comment on if you remember now, the question on, okay.
Speaker 4
Yeah. Regarding the 403, we have amended study both populations, major depressive disorder and bipolar disorder and mixed features. And, the primary efficacy endpoint will be Medrost Total Score because the primary diagnosis is depression with mixed features. And for the mixed features for the hypomanic symptoms, and the manic symptoms that we see, we are also measuring YMR's young linear rating scale in the study that will give us the information regarding the manic symptoms.
Speaker 0
Our next question comes from the line of Mark Goodman with SVB Leerink. Your line is now open.
Speaker 7
Hi, this is Rhona on the line for Mark. Thanks for taking the question. I have 2. First on the 403 study, Could you remind us about your expected top line readout timing given the amendment? And second question is flipping to schizophrenia.
I was curious if you could give us any color if possible on any persistence rates or discontinuation rates you're observing from 2Q to 3Q? Thanks.
Speaker 2
So I'll take the first part. And I I'll start with saying that I'd like to remind you that this study is not part of our sNDA. Of course, safety data is always reported where you are, but it will not be our sNDA is not dependent upon Study 40three. That's first. Then you asked about the readout time.
Because of these times of COVID, we're giving ourselves a lot of a lot of time here. I guess for your next question is about persistence and I think it's a little early to talk about that, but Mark, do you want to add anything about that?
Speaker 3
Yes. No, that's right, Sharon. It is too early to get sort of the longitudinal persistence and compliance rates that you're asking about. But what I would say is what we are tracking very closely is the refill rate of prescriptions. And we've been very pleased to see a high refill rate consistent with our expectations given the profile of Caplido with a favorable safety and tolerability profile and the efficacy profile that it has.
And as we track those and look at historical benchmarks, we are tracking ahead of historical benchmarks in this area. So we're actually very pleased with the refill rates we're seeing.
Speaker 0
Thank you. Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open.
Speaker 10
Hi. It's Leo on for Brian. Thanks for taking my question. I guess I had a kind of a multipart question on MDD. So just to clarify, is Study 40three going to be in monotherapy for MDD and is this going to be able to support an sNDA for MDD?
And then looking ahead to the other 2 MDD trials that you're going to be running, can you give any initial thoughts on you think are going to be primary and secondary endpoints, patient enrollment numbers? And then I guess just lastly on that same point, I mean, MDD and bipolar often there's some misdiagnosis there. So I'm just wondering if you've had an opportunity to look back across the bipolar trials and perhaps see any initial hints of efficacy in MDD. Thanks.
Speaker 2
Go ahead, Suresh. I was going to just shorten it for the sake of time, but go ahead and then I'll fill in.
Speaker 4
In terms of, the first question for, the 403, it is in monotherapy, with studying patients major depressive disorder and bipolar depression, with mixed features. So that is a monotherapy trial. In terms of the adjunct treatment, as we said, the clinical conduct will begin in 2020. And we will update shortly once the tiles are started on symptoms.gov. The details of the primary endpoint and the other details in terms of the sample size, all that will be posted.
Central standard.
Speaker 0
Thank you. Our next question comes from the line of Jason Butler with JMP Securities. Your line is now open.
Speaker 10
Hi, it's Roy in for Jason. Thanks for taking the question. Just a quick one. Can you give us an update on the plans and timing for ITI 214? Thanks.
Speaker 2
Yes. Hi, this is Sharon. Thanks for the question. So we we had a lot going on this quarter, and we really had, wanted to make sure that we spent all the time on Lumateperone and those products. We did talk about the long acting injectable and we also did talk about triple 3.
The PDE1 programs, of which there are a few, both preclinical and that will go into clinical more clinical studies. For instance, in Parkinson's disease, we will update you on that on our next call.
Speaker 0
Thank you. Our next question comes from the line of Andrew Gisai with Jefferies. Your line is now open.
Speaker 11
Thanks. Good morning. I guess my question is as investors do more work in the bipolar depression market, Can you maybe just kind of explain how physicians are currently treating bipolar 1 and 2 depression? Are all I guess patients in the U. S.
Treated by antipsychotics, Lithium valkyrate or is there going to be some white space out there for CAPletta? And I guess a secondary question to that is just within bipolar depression, are patients cycling through available therapy similar to the dynamic we see in the schizophrenia market. Thanks.
Speaker 2
Okay. I'll start and then I'll ask if Suresh wants fill anything in. And I'll sort of go backwards. There's definitely white space. As you call it, because there are many patients with bipolar disorder who are not being treated right now.
As Mark mentioned, there are 11,000,000 Americans with bipolar disorder. Patients do cycle through these drugs as well as what we see with schizophrenia, of course, there are fewer of these drugs. So they do So they have fewer options to cycle through. I missed some of your other questions I know you had a couple more. Andrew are you there?
Speaker 4
Hello?
Speaker 2
Yeah. Well, I'm sorry. We couldn't hear you.
Speaker 11
Okay. I personally just want to understand if within the bipolar two spaces, seroquel is being used for all bipolar 2 patients and patients have exhausted that. Antipsychotic and there are no treatment options left?
Speaker 2
Seroquel is being used. Other other drugs are being used as well. The extent to which they're used is a little bit, the numbers, are not exact. Mark, do you want to fill in? Do you want to add to that?
Speaker 3
Yes, I'm sorry, Andrew, could you just restate your question on that?
Speaker 11
Yes. I mean, there seems to be a lot of, in theory, bipolar 2 depression patients in the U. S. And so given that seroquel is the only drug approved technically in the label for bipolar 2? I mean, have all patients essentially gone on seroquel bipolar or 2 patients?
Thanks.
Speaker 3
Yes, no, I wouldn't think that all patients have gone on to Sarahquel. What I would say for us, from a commercial perspective, having the indication for, which we would expect upon approval, gives us the opportunity as a commercial organization to actively promote in that patient population. And I also think that it gives physicians added confidence that the FDA has approved for efficacy and safety, specifically in that patient population and we believe that will be a very strong, compelling message for CaplaIDA, again, if and when we are approved in bipolar depression.
Speaker 11
Makes sense. Okay. Thank you.
Speaker 0
Thank you. This concludes today's question and answer session. Would now like to turn the call over to Doctor. Sharon Mates for closing remarks.
Speaker 2
Great. Thank you, operator, and thank you. All for participating on today's call. We're very excited as we move forward. With our next indication of filing for the treatment of bipolar depression and with our long acting injectable as well as our programs like triple 3 and the 2 14 programs.
So we look forward to updating you. In the near future. And I think operator, you can now disconnect. Thank you.
Speaker 0
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.