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Minerva Neurosciences, Inc. (NASDAQ:NERV)
Q2 2019 Earnings Call
Aug. 5, 2019, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Welcome to the Minerva Neurosciences second quarter 2019 conference call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session following today's prepared remarks. This call is being webcast live on the Investor Relations of Minerva's website at ir.minervaneurosciences.com. As a reminder, today's call is being recorded. I would now like to turn the call over to William Boni, Vice President of Investor Relations and Corporate Communications at Minerva. Please proceed.

William Boni -- Vice President, Investor Relations and Corporate Communication

Good morning. A press release with the company's second quarter 2019 financial results became available at 7:30 a.m. Eastern time today and can be found on the Investors section of our website. Our quarterly report on Form 10-Q was also filed electronically with the Securities and Exchange Commission this morning and can be found on the SEC's website at www.sec.gov.

Joining me on the call today from Minerva are Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer, Mr. Geoff Race, Executive Vice President, Chief Financial Officer, and Chief Business Officer, and Mr. Rick Russell, President. Following our prepared remarks, we will open the call for Q&A.

Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated.

These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption "Risk Factors" in our filings with the SEC, including our quarterly report on Form 10-Q for the quarter ended June 30th, 2019, filed with the SEC on August 5th, 2019. Any forward-looking statements made on this call speak only as of today's date, Monday, August 5th, 2019, and the company disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after today's call, except as required by law. I would now like to turn the call over to Remy Luthringer.

Dr. Remy Luthringer -- Executive Chairman and CEO

Thank you, Bill, and good morning, everyone. Thanks for joining us today. The first half of 2019 has been very productive for Minerva. We announced positive top-line results in two Phase 2b trials with seltorexant, our orexin-2 antagonist currently in development for two indications: Major depressive disorder -- MDD -- and insomnia. I am pleased to report that we have just attained top-line results in the first study with seltorexant. This biomarker study, designated as MDD1009, was carried out in parallel with the Phase 2b trials. The top-line results show improvements in symptoms of depression MDD patients when seltorexant is given as a monotherapy. I will provide further information on these results later in the call.

We have also made good progress in the enrollment of patients into our three additional late-stage clinical trials. This includes the ongoing pivotal Phase 3 trial with roluperidone, the further Phase 2 trial with seltorexant, for which recruitment has been completed, and the Phase 2b trial with MIN-117. As you know, our mission at Minerva is to develop drugs to address unmet medical needs in patients living with serious neuropsychiatric disorders.

In our lead program, roluperidone, we have demonstrated in the Phase 2b trial that the drug, given in monotherapy, showed a specific improvement of negative symptoms in patients suffering from schizophrenia. To the best of our knowledge, this remains the first time such a specific effect has been shown. The recent seltorexant data -- also for the first time in the orexin class -- demonstrates efficacy in both adjunctive and monotherapy treatment of MDD.

So, let me today start with seltorexant, as we have announced significant data with this molecule over the last quarter. Seltorexant is a selective orexin-2 receptor antagonist that we are co-developing with Janssen Pharmaceutica NV. To the best of our knowledge, seltorexant is the only late-stage specific orexin-2 antagonist in development. All other clinical-stage molecules are orexin-1 and -2 antagonists.

The orexin system of the brain is extremely potent and involved in the control of several key functions. These include regulation of certain metabolic functions, brain function modifications linked to abnormal stress levels and/or hyperarousal, and sleep-wake recent dysregulation, which may lead to sleep disorders like insomnia.

As I mentioned earlier, we conducted the biomarker study known as MDD1009, studied in 128 patients with moderate to severe MDD. This multicenter, placebo-controlled, randomized, double-blind study of two doses of seltorexant, 20 mg and 40 mg, were given as monotherapy and not as an add-on treatment to SSRIs and/or SNRIs, as in the recent MDD2001 study. Monotherapy, rather than adjunctive treatment, was chosen for this study to evaluate the mechanism of action of seltorexant alone and to avoid the variable effects of antidepressant drugs.

The primary objective of the study was to analyze the treatment effect of seltorexant versus placebo on symptoms of depression, as measured by the Hamilton Rating Scale for Depression 17 -- HDRS-17 -- the presence of subjective sleep disturbance subjective sleep assessment, Insomnia Severity Index -- ISI -- and Ruminative Response Scale -- RRS -- as a possible indicator of hyperarousal was used as a stratification factor in patient randomization.

I am pleased to announce that the primary endpoint analysis showed a significant treatment effect at week 5 for seltorexant versus placebo. The efficacy signal for the 20 mg dose was statistically significant (p=0.0049) and more pronounced in the MDD population with sleep disorder, measured as having an ISI superior to 15 and subjective sleep onset latency superior to 30 minutes during at least three nights over seven recorded days and in MDD patients with higher rumination, measured as having a Rumination Response Scale, or RSS, superior or equal to 50.

While the seltorexant 40 mg dose did not show a statistically significant effect at week five, although the efficacy signal was also more pronounced in MDD patients with presence of subjective sleep disorder, measured as having an ISI superior to 15. These new findings from the MDD1009 study show that seltorexant administered as monotherapy improves depressive symptoms, and that the improvement is more pronounced when patients also have insomnia. Importantly, they also support the relationship between hyperarousal, clinical efficacy, and the mechanism of action of seltorexant.

On May 13, 2019, we announced positive top-line results from the MDD2001 trial, the Phase 2b trial of seltorexant as adjunctive therapy to antidepressants in other patients diagnosed with major depressive disorders and not adequately responding to serotonin reuptake inhibitors -- SSRIs -- and/or serotonin-norepinephrine reuptake inhibitors -- SNRIs. In this dose-finding study, the 20 mg dose of seltorexant showed a statistically significant improvement in the Montgomery-Asbert Depression Rating Scale -- MADRS -- score compared to placebo at six weeks. Seltorexant was also observed to have even greater improvement over placebo in patients with clinically significant insomnia and a favorable tolerability profile. Additional analysis of the data is ongoing, and complete details are planned for presentation during the next ACNP meeting, in December of this year.

Let me now move to our recent insomnia results from study ISM2005, recently presented in a press release and discussed during a KOL call on June 24th, 2019. This study, which was conducted in elderly patients with insomnia, explored the effects of 5, 10, and 20 mg of seltorexant. It was placebo-controlled, and included an active arm of zolpidem, also known as Ambien. Positive top-line results from this study demonstrated highly statistically significant and clinically meaningful improvements in the primary endpoint, latency to persistent sleep -- LPS -- at night one after treatment with 10 and 20 mg doses of seltorexant.

In addition to the primary endpoint, multiple secondary endpoints were improved with seltorexant versus placebo and standard-of-care zolpidem. Furthermore, the beneficial effects of seltorexant on elderly patients, in conjunction with a favorable tolerability profile, suggest its potential benefit in the large and growing population of elderly patients, whose prevalence of sleep disorders, including insomnia, is higher than in younger patients.

To summarize, the data announced this past quarter demonstrate that seltorexant is able to improve depressive symptoms in MDD patients not responding adequately to first-line therapies, as well as in MDD patients treated with monotherapy. The observed new improvements in these patients are more pronounced when associated with insomnia.

In addition, improvements in insomnia were observed in patients without associated neuropsychiatric comorbidities, and these improvements were superior to those observed after treatment with zolpidem and present in adults and in the elderly. Importantly, these therapeutic effects were observed without major side effects, as the safety and tolerability profile of seltorexant is comparable to placebo. Taken together, the findings from the three trials conducted today confirm the unique ability of seltorexant to address unmet medical needs in both mood and insomnia disorders.

Let me now provide an update on roluperidone, our most advanced program, in a pivotal Phase 3 trial. We are continuing to recruit patients in this trial with a diagnosis of schizophrenia who present with negative symptoms. This trial will enroll approximately 500 patients at approximately 60 clinical sites in the U.S. and Europe. The design of the Phase 3 trial is fundamentally consistent with that of our successful Phase 2b trial. We are seeking to replicate a statistically significant improvement in the negative symptoms observed in the Phase 2b as measured by the PANSS scale, which constitutes our primary endpoint.

Furthermore, we are assessing two secondary endpoints, which are the PSP, Personal and Social Performance scale, total scores, and the CGI Severity scale. The reason for selecting these two secondary endpoints is to demonstrate that an improvement in negative symptoms translates into functional improvements in patients treated with roluperidone.

With respect to the effects observed on the PSP scale in our Phase 2b study, I am pleased to report that the scientific publication has been accepted recently in the Schizophrenia Research Journal about the scale, which is one of the best ways to show the improvement in negative symptoms translates into a functional improvement in patients treated with roluperidone.

Concerning the Phase 3 study, our main focus is on the close monitoring of sites in Europe and in the U.S. to ensure adherence to key parameters of this trial. This includes careful patient selection and objective assessment of patient symptoms during the treatment phase. We expect the readout data from the 12-week double-blind treatment period of the Phase 3 trial in the fourth quarter of 2019.

In parallel, we are also moving forward with considerable preparatory work for the filing of a new drug application -- NDA -- for roluperidone, pending a positive Phase 3 study. We recently have completed a clinical pharmacology trial focused on drug-drug interaction -- DDI -- studies, which comprise a standard part of the NDA. Without going into too many details, these include interactions with molecules separately inhibiting two subtypes of the cytochrome P450, CYP36 and CYP3A4. The data from this study are currently being analyzed, and preliminary data show minimal interaction. Our commercial team also continues to work on the positioning and launch strategy for roluperidone.

Moving on to our last clinical stage product, we are continuing to recruit patients in our Phase 2b trial with MIN-117. Patients recruited in this trial have a diagnosis of MDD associated with anxiety. Based on our previous clinical findings, we believe that these patients may benefit particularly from treatment with MIN-117. Approximately 324 patients are expected to be enrolled in this trial at about 40 sites in the U.S. and Europe. The study design includes a screening phase, a six-week double-blind treatment phase, and a two-week post-study follow-up period. Planned results are expected in the fourth quarter of 2019.

In summary, the first half of 2019 has been tremendously exciting, with really important clinical readouts for seltorexant that demonstrate the potential of this molecule to treat multiple groups of patients in the therapeutic areas of MDD and insomnia. We look forward to the second half of the year, which will provide important results for our two late-stage clinical molecules, roluperidone and MIN-117. I will now turn it over to Geoff, who will describe our financials in greater detail.

Geoff Race -- Executive Vice President, Chief Financial Officer, and Chief Business Officer

Thank you, Remy. Earlier this morning, we issued a press release summarizing our operating results for the second quarter ended June 30th, 2019. A more detailed discussion of our results may be found in our quarterly report on Form 10-Q, filed with the SEC earlier today. Cash, cash equivalents, restricted cash, and marketable securities as of June 30th, 2019 were approximately $69.4 million. The company believes that its existing cash, cash equivalents, restricted cash, and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months from today and into early 2021, based on our current operating plan. The assumptions upon which this estimate is based are routinely evaluated and may be subject to change.

Research and development expenses were $8.3 million in the second quarter of 2019 compared to $9.1 million in the second quarter of 2018, a decrease of $0.8 million. This decrease primarily reflects decreased non-clinical and clinical pharmacology expenses, partially offset by increased costs in the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117.

For the six months ended June 30th, 2019, R&D expenses were $19.9 million compared to $17.5 million for the six months ended June 30th, 2018, an increase of $2.4 million. This increase primarily reflects higher development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117. We expect R&D expenses to increase during 2019, as we increased patient enrollment and related support activities for the roluperidone and MIN-117 clinical trials.

General and administrative expenses were $4.6 million in the second quarter of 2019 compared to $3.9 million in the second quarter of 2018, an increase of approximately $0.7 million. For the six months ended June 30th, 2019, G&A expenses were $9.3 million compared to $8.2 million for the same period in 2018, an increase of approximately $1.1 million. These increases in G&A expenses were primarily due to an increase in non-cash stock-based compensation expenses and salary costs from increased staffing to support our pre-commercial activities. We expect G&A expenses to increase during 2019 as we prepare for the transition of roluperidone from clinical development to commercialization.

Net loss was $12.5 million for the second quarter of 2019, or a loss per share of $0.32 basic and diluted, as compared to a net loss of $12.5 million, or a loss per share of $0.32 basic and diluted for the second quarter of 2018. Net loss was $28.3 million for the first six months of 2019, or a loss per share of $0.73 basic and diluted, as compared to a net loss of $24.9 million, or a loss per share of $0.64 basic and diluted for the first six months of 2018. Now, I'd like to turn the call back to the operator for any questions.

Questions and Answers:

Operator

Thank you. Ladies and gentlemen, if you have a question at this time, please press *1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press #. Our first question comes from Joel Beatty with Citi. Your line is open.

Joel Beatty -- Citigroup Research -- Analyst

Hi. Thanks for taking the questions. The first one is on seltorexant. The Phase 2 results coming this quarter -- obviously, we've already seen data from a couple of trials there, so how could the Phase 2 results coming affect the overall picture of where seltorexant program is at, and the decision-making process of how to go ahead with that program?

Dr. Remy Luthringer -- Executive Chairman and CEO

Hello, Joel. Remy speaking. As I always explain -- and, I think I explained this during the last earnings call -- we had them in the last study we are reading out very soon. The study is a comparison over a period of six months between our molecule and quetiapine, which is the standard of care for patients who are not responding adequately to SSRIs or SNRIs. So, this is mostly a study to better understand how the things are comparing between the standard of care and our molecule, obviously in terms of safety, because as you know, quetiapine is an antipsychotic and has all the side effects of antipsychotics, and really, also to have some long-term data with our molecule.

So, I think it will not change the basic plan of the Phase 3, or the registrational studies will be the same, but having in addition the data from this 2002 study coming will help us to really fine-tune the plan in order to really demonstrate the value of our molecule compared to standard of care. So, again, important study, but it does not change where we are going.

Joel Beatty -- Citigroup Research -- Analyst

Okay, got it. A question about the Phase 3 roluperidone program -- the mix of patients between Europe and the U.S. -- first of all, can you give us a sense of the range of the breakdown of how it might fall into? Is it going to be exactly 30% of patients in the U.S., or is there some wiggle room there? And then, the second part of the question is are you able to give a sense based on the blinded data how patients compare in the U.S. and Europe in this trial?

Dr. Remy Luthringer -- Executive Chairman and CEO

So, as you know, what we have discussed with the FDA at the end of the Phase 2 meeting is to do our best defaults to come as close as possible to 30% of the patients coming from the U.S. As of today, things are quite in line with these numbers, but it's obviously not 30% exactly, but it's very well in line. Now, concerning your second question, yes, indeed. As you know, I'm a big fan of checking the quality of the data, comparing the data from country to country, from side to side, and because the U.S. is -- if you want to observe, the only difference between Phase 2b and Phase 3 is because in Phase 2b, we only had European sites.

I'm obviously carefully following what is going on in the U.S., and I have to say that I am really very reassured about the results because when we are analyzing our data, obviously, completely blinded, so I don't know what is going on between placebo and treatment, but completely blinded, the U.S. is performing as well as Europe. And, I was always concerned about the way these patients are recruited in the U.S. because we are dealing here with negative symptoms. You need to check the stability of the negative symptoms over a certain period of time before including the patients, but once the patients are in the study, I think the U.S. sites are doing a great job assessing the symptoms of the patient. So, again, we have more screen failures, so less patients were included in the study, but once the patients are in the study, I think we cannot see any difference between U.S. and Europe, which is extremely reassuring for the outcome of the study.

Joel Beatty -- Citigroup Research -- Analyst

Great. And then, maybe one last question. If the Phase 3 results are successful, could you discuss the timeline for filing and any other steps that need to be taken in order to prepare the NDA filing?

Dr. Remy Luthringer -- Executive Chairman and CEO

So, obviously, we are working -- as I mentioned, we are working really hard on the NDA preparation. As you have seen also, we have now completed the DDI studies we discussed with the FDA at the end of the Phase 2 meeting, so I think we are really ready based on positive data of the Phase 3 to really start to discuss with the FDA. So, really, I think what we have announced before will be respected because we are ready with all the different modules of the NDA. Obviously, we need to have the results of the Phase 3 -- the double-blind phase -- and afterwards, as you know, we are proposing to the patient the extension of nine months in order to have 12 months' safety data. This will come in on a rolling basis, but definitely, we are completely on time for the NDA filing.

Joel Beatty -- Citigroup Research -- Analyst

Great, thank you.

Dr. Remy Luthringer -- Executive Chairman and CEO

Thank you, Joel.

Operator

Thank you. And, our next question comes from Douglas Tsao with H.C. Wainwright. Your line is open.

Douglas Tsao -- H.C. Wainwright -- Managing Director

Hi, good morning. Thanks for taking the question. Remy, going back to the MDD1009 study for seltorexant, just as a follow-up there, how does this affect your thinking or inform you when you think about moving ahead with that molecule into pivotal trials? We obviously already knew about the effect as an antidepressant as well as the effect on sleep, and so, I'm just curious -- from your perspective, what was the big, key takeaway?

Dr. Remy Luthringer -- Executive Chairman and CEO

Great question, obviously, and I think the good problem we have here is that we have another option because this is really a very nice demonstration that this drug has a direct effect on mood. It's really confirming what we have seen before, but this is the first time we are doing a study in monotherapy. So, I think it does not really change our view because what it confirms -- and, we are continuing to work on analyzing additional data coming out from this study because we are looking to cortisol, we are looking to some aspects which are able to detect arousals, which are able to detect stress, and we will learn more about the mechanism of action, but basically, what all the data we have today are confirming -- you take the add-on data in depression, you take this monotherapy data in depression, you take our data in insomnia -- are showing that this is a very innovative mechanism of action, and I'm really insisting on this because if you compare this to dual antagonists, this is not a dual, just the same profile.

Interestingly enough, in our case, we cannot discriminate in terms of side effects from placebo, so we have a very good safety profile. So, I think it's just confirming what we were thinking -- how the drug is working -- and it gives us even more confidence that what we are doing going forward in Phase 3 will be successful. But, it does not change anything in terms of thinking, in terms of development planning.

Douglas Tsao -- H.C. Wainwright -- Managing Director

Okay. And so, just to sum -- not to put words in your mouth -- so, in some ways, the big value is the monotherapy. It removes any sort of confounding factor of the adjunctive therapies that were being given in the previous trials.

Dr. Remy Luthringer -- Executive Chairman and CEO

You're completely right.

Douglas Tsao -- H.C. Wainwright -- Managing Director

And, does that give you incremental thought to testing it as a monotherapy, or do you continue to think -- at least, in depression -- it would be more as an adjunctive therapy?

Dr. Remy Luthringer -- Executive Chairman and CEO

So, as of today, we have not completely finalized our Phase 3 development program with our work colleagues from Johnson & Johnson because as you know from the depression indication, this is something we are doing in complete transparency and discussion with our colleagues from Johnson & Johnson. I don't think it will change our way to see the future in Phase 3, which will be probably add-on to existing therapies, but again, don't take it as completely granted because the discussions are still going on. But again, I think it's just confirming that here, we are dealing with a drug which is not only doing something on insomnia, but is really having a direct effect on depression, which is definitely very reassuring. But, I think it will not change the picture moving forward.

Douglas Tsao -- H.C. Wainwright -- Managing Director

Okay, great. Thank you so much, Remy.

Dr. Remy Luthringer -- Executive Chairman and CEO

You're welcome.

Operator

Thank you. And, as a reminder, if you would like to ask a question, press *1 on your touchtone telephone. We have a question from Jason Butler with JMP Securities. Your line is open.

Jason Butler -- JMP Securities -- Managing Director

Hi. Thanks for taking the questions. Just another one on the new data from the 1009 study. Remy, can you maybe speak to how these new results impact your views on advancing the 40 mg dose as well as the 20 mg dose into the next stages of development.

Dr. Remy Luthringer -- Executive Chairman and CEO

Jason, I was expecting this question. Great question. Clearly, 20 mg is crystal clear. As you have seen, we have exactly the same results in monotherapy as the results we have seen in add-on, so 20 mg is and will remain the cornerstone dose. We are still working on better understanding what is going on with 40 mg. A lot of work is currently ongoing. We're trying to understand how the free fraction of the drug is impacting the results. So, we are really working very hard on this 40 mg data. In other words, to be more precise, we are really working on checking if there is a dose-dependent or exposure-dependent effect on mood. Things are still ongoing, and I think based on this data, which will probably be available very soon and we will sit together with our colleagues from Johnson & Johnson, we will decide if the Phase 3 will be with one dose or with two doses including 40 mg.

So, stay a little bit with us, and in the next quarter, I can give you complete clarity of where we are going, but again, 20 mg is definitely confirmed to be the cornerstone dose, and as you have seen also for insomnia, 20 mg is an important dose. You have also seen that with 10 mg, we have a very nice effect on insomnia, so obviously, with insomnia, we are also contemplating lower doses than 20 mg. But again, stay with us for a few more weeks, and I will give you the complete clarity on where we are going.

Jason Butler -- JMP Securities -- Managing Director

Great. Very helpful. Thanks for taking the question.

Dr. Remy Luthringer -- Executive Chairman and CEO

Thank you.

Operator

Thank you. Our next question comes from Biren Amin with Jefferies. Your line is open.

Biren Amin -- Jefferies -- Managing Director

Hi, guys. Thanks for taking my questions. Remy, on roluperidone's Phase 3 trial, can you talk about the readthroughs from the recent Acadia study that have failed?

Dr. Remy Luthringer -- Executive Chairman and CEO

Yeah. So, thank you for the question. I think it's very complicated to draw some conclusions from the Acadia study because as we have seen, the Acadia study is a study where the drug has been given on top of antipsychotics for inpatients who are not responding well to antipsychotics. The score of the patients entering the study was quite high on the PANSS scale, and so, the study design is completely different, obviously, what we are doing, and this study was not stratified, for example, in terms of negative symptoms. I know that there is another study coming soon from our colleagues from Acadia where they are going with a minimum score of negative symptoms, but again, it will be add-on to antipsychotics.

So, long story short, I think we cannot draw any conclusion from the study concerning our trial. Obviously, there is something in common, which is the 5-HT2A antagonism or inverse agnosim -- which, by the way, is giving the same pharmacological effect. What it means is that the 5-HT2A component is definitely contributing to help in terms of controlling positive symptoms. It might also have a small beneficial effect, for example, on cognition. It definitely has an effect on sleep. So, clearly, what this data tells me is that 5-HT2A is important, but not enough in order to really move the needle in terms of negative symptoms and cognition. When you look into our drug, it is very clear that the effect is driven by the synergistic combination of the 5-HT2A antagonism and the sigma-2 antagonism. So, again, interesting, important data, but we cannot really conclude based -- to expand to our data, definitely not.

Biren Amin -- Jefferies -- Managing Director

And then, maybe just some follow-up questions. On seltorexant, the 1009 trial, can you talk about if you saw treatment effect difference with the 20 mg dose before week 5? I guess this question is how quick was the onset of the effect?

Dr. Remy Luthringer -- Executive Chairman and CEO

So, it is definitely following the same time course as what we have seen in the add-on study. Definitely, you start to see a differentiation between a placebo and treatment after two weeks because this was the first time we measured, really, and the things are building up over time. So, definitely, exactly the same time course as what we have seen in the add-on study. This is what you can have as a take-home message from this data -- which, by the way, is very reassuring because I'm always intrigued if one study shows something and the other shows something different. Here, in this case, it means the time course of the effect on mood is exactly the same.

Biren Amin -- Jefferies -- Managing Director

And then, on the 2002 trial that's ongoing, where you're expecting that data in Q3, are you evaluating both the 20 and the 40 mg doses?

Dr. Remy Luthringer -- Executive Chairman and CEO

In fact, it's a great question. It's a flexible dose study, so basically, we give the possibility -- because as you know, quetiapine is also -- when you prescribe quetiapine for patients who are not responding well to existing antidepressants, you give the flexibility to the prescriber to have different doses and to adapt the dose. So, what we have done in this study in order to be very similar or comparable to standard of care, we give the possibility to the PIs or to the sites to have an opportunity to give 20 or 40 mg, so definitely, they have the possibility to decide about the dose. This is a flexible dose study. Clearly, we have 20 and 40 mg. We will obviously analyze also the study of the patients who have received 20 mg compared to 40 mg in order to continue to check what is going on between the two doses, but definitely, this is a flexible dose study.

Biren Amin -- Jefferies -- Managing Director

Great, thank you.

Dr. Remy Luthringer -- Executive Chairman and CEO

Thank you so much.

Operator

Thank you. And, I'm showing no further questions at the time. I'd like to turn the call back to Mr. Remy Luthringer for any further remarks.

Dr. Remy Luthringer -- Executive Chairman and CEO

So, thank you for all these questions, and thank you for everybody attending this call, and I am really looking forward to updating you on our progress in the near future because the second half of this year will be also a very important second half of the year, like it has been since the beginning of the year, so we look forward to speaking with you again soon.

Operator

Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect. Everyone, have a great day.

Duration: 39 minutes

Call participants:

William Boni -- Vice President, Investor Relations and Corporate Communication

Dr. Remy Luthringer -- Executive Chairman and CEO

Geoff Race -- Executive Vice President, Chief Financial Officer, and Chief Business Officer

Rick Russell -- President

Joel Beatty -- Citigroup Research -- Analyst

Douglas Tsao -- H.C. Wainwright -- Managing Director

Jason Butler -- JMP Securities -- Managing Director

Biren Amin -- Jefferies -- Managing Director

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