Minerva Neurosciences (NERV) Q2 2020 Earnings Call Transcript

Minerva Neurosciences (NERV -1.20%)
Q2 2020 Earnings Call
Aug 03, 2020, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Welcome to the Minerva Neurosciences second-quarter 2020 conference call. [Operator instructions] The call is being webcast live on the investors section 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, investor relations, and corporate communications at Minerva.

Please proceed.

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

Good morning. A press release for the company's second-quarter 2020 financial results and business highlights 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; and Mr. Geoff Race, executive vice president, chief financial officer, and chief business officer. 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 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 30, 2020, filed with the SEC on August 3, 2020. Any forward-looking statements made on this call speak only as of today's date, Monday, August 3, 2020, 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.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Thank you, Bill, and good morning, everyone. Thanks for joining us. I hope everyone is doing well. Today, I will focus primarily on Minerva's lead product, roluperidone, which recently completed the double-blind part in a Phase 3 trial for the treatment of negative symptoms in patients suffering from schizophrenia.

The significant unmet medical need is the main reason why patients with schizophrenia suffer from diminished function. And it places a huge burden of patients to families and the healthcare system. Today, there is no approved treatment for negative symptoms in the United States. Based on the review of the Phase 3 data, which builds on the Phase 2b data, as well as additional data we have compiled over years.

We continue to believe that roluperidone has a potential to be the first drug to improve negative symptoms directly and specifically. After giving an update on roluperidone, I will also discuss the seltorexant program and our decision to opt out of the co-development agreement with Janssen Pharmaceutica. Today, I would like to begin with an update on the review of data from the recent Phase 3 trial of roluperidone. The trial evaluated two doses of roluperidone, 32 and 64 milligram, over 12 weeks.

The study was carried out in about 60 clinical sites in the U.S., Europe and Israel. More than 500 patients were included in the trial. Following the 12-week double blind phase, patients were offered an additional nine months expansion period of treatment with roluperidone on either 32 or 64 milligram. I'm pleased to report that over 300 patients entered the extension and more than 100 patients have now completed the overall one-year treatment period.

I'm also very pleased to report that only a limited number of patients dropped out of the studies as a result of worsening of positive segments. This continues to be observed to date in the nine months extension. So what have we learned about roluperidone and schizophrenia from this trial so far? Statistically significant differences were observed for the primary endpoint, the negative core proposed by Steve Marder, NSFS, negative symptoms factor score, extracted from the PANSS scale between active doses and placebo at week four, both doses; and week eight, 64 milligram only. Both groups receiving active treatment showed numerically superior improvements in NSFS to placebo at week 12.

Also, the placebo improvement was high as well in the Phase 3 trial compared to the Phase 2b trial. We believe this may be why statistical significance was not achieved at week 12. Functional improvement, as measured by the personal and social performance scale or PSP, was statistically significantly superior with the 64-milligram dose at all assessed weeks with nominal p-value of 0.021 at week 12. We continue to explore the drivers behind the improvement of negative symptoms and consequently, functional improvement by looking at this core component of negative symptoms.

And we suspect it is largely driven by a meaningful improvement in the patient's level of avolition or lack of interest or engagement in goal-directed behavior. So what is next? Once we complete our additional analysis of the Phase 3, we will be requesting a meeting with the FDA to discuss our data package and the path forward for roluperidone's development. I would now like to address our second clinical stage program, seltorexant, MIN-202. On July 1, 2020, we announced that we exercised our right to opt out of our agreement with Janssen for the future development of seltorexant.

As a result, Minerva will collect a royalty in the mid-single digits on worldwide sales of seltorexant in all indications with no financial obligations to Janssen moving forward. The decision to opt out of the agreement at this stage of the program enables us to retain a meaningful financial interest in the future revenue stream of a compound with significant commercial potential in multiple indications. At the same time, it eliminates the company's obligation to make significant financial payments to fund the large Phase 3 program. Our decision to opt out will enable us to align our human and financial resources with our primary focus to see the approval of our lead compound, roluperidone, and to help those patients for which there is currently no effective treatment.

Before handing over to Geoff to give you the financial update, I would like to restate our conviction that roluperidone has significant potential to be the first drug approved to treat negative symptoms. Conviction is based on our growing understanding of negative symptoms and the recent Phase 3 data, combined with the data that we have accumulated over the past few years. This encouraging data, combined with an innovative mechanism of function and favorable safety profile gives us confidence in the future of roluperidone. The roluperidone, as mentioned, important program, both for the potential benefit of patients and their families and the significant commercial opportunity to effectively create negative symptoms in schizophrenia and beyond.

I will now turn it over to Geoff.

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 30, 2020. 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 30, 2020, were approximately $35.3 million.

We presently expect that the company's existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements into early 2022 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 $5.8 million in the second quarter of 2020, compared to $8.3 million in the second quarter of 2019. For the six months ended June 30, 2020, R&D expenses were $13.8 million, compared to $19.9 million for the six months ended June 30, 2019.

The decreases in R&D expenses during the quarter and six months ended June 30, 2020, primarily reflect lower 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 decrease during 2020 as we have completed the MIN-117 clinical trial and the 12-week double-blind portion of the Phase 3 clinical trial of roluperidone. General and administrative expenses were $5.9 million in the second quarter of 2020, compared to $4.6 million in the second quarter of 2019. For the six months ended June 30, 2020, G&A expenses were $10.1 million, compared to $9.3 million for the same period in 2019.

The increases in G&A expenses during the quarter and six months ended June 30, 2020, were primarily due to increases in noncash stock-based compensation expenses and severance benefits. Net income was $29.5 million for the second quarter of 2020, or net income per share of $0.75 and $0.73, basic and diluted, respectively, 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 2019. Net income was $17.4 million for the first six months of 2020, or net income per share of $0.44 and $0.43, basic and diluted, respectively, as compared to a net loss of $28.3 million, or a loss per share of $0.73, basic and diluted, for the first six months of 2019. As a result of opting out of the agreement with Janssen, the company recognized $41.2 million in collaborative revenue during the second quarter of 2020, which had previously been included on the balance sheet under deferred revenue.

This amount represents the $30 million payment made by Janssen in 2017 and the $11.2 million in previously accrued collaborative expenses given by Janssen upon the effective date of the amendment. The company does not have any future performance obligations under the agreement and will recognize any future royalty revenues in the periods of the sale of products related to the agreement. Now I would like to turn the call over to the operator for any questions. Operator?

Questions & Answers:

Operator

[Operator instructions] Our first question comes from Joel Beatty with Citi.

Shawn Egan -- Citi -- Analyst

Hi. This is Shawn Egan calling in for Joel. Thank you for taking my questions. A few for me today.

Maybe a little bit more on your decision to opt out of the seltorexant program. Why you think that was the right decision at the time? And can you provide any color on whether Janssen still plans to develop this asset going forward? And then, I have a follow-up question on roluperidone as well.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So thank you for the question. It is Remy speaking here. So clearly, I mean, I think this molecule is a very interesting molecule, a very important molecule. And obviously, we cannot speak in for Janssen, but I think this is really a project which is really moving forward.

And I really hope that this molecule is going to patients who need this kind of treatment. For the first part of the question, maybe Geoff, you can take it, why we opted out?

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

Yeah, thanks for the question, Shawn. The decision to opt out was really based on a return on investment decision. We were looking at the benefits of this program, the European rights that we had as part of our agreement with Janssen and the royalty rate compared to the size of the investment that we would have to make in the Phase 3 program. And we felt that it was a better return for Minerva and its shareholders to opt out of the program and take the smaller royalty as described by Remy in his update earlier today.

Shawn Egan -- Citi -- Analyst

Perfect, thank you. And then, on roluperidone, how and when do you plan to share kind of the additional details of the Phase 3 publication? And I guess, when that data is presented, what are the most important data metrics for investors to be kind of zeroing on?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So it's, obviously, a great question, and it's a question we are getting quite often elsewhere. So what I can say about this is that, I mean, we have really done a lot of additional analysis. I alluded to this in my talk just before or in my update just before. Clearly, I mean, even if we did not hit a p-value at week 12, all the data we have in hand and all the additional analysis are showing that, I mean, this translates into a functional improvement of the patients.

And I also hinted to it, it's clear that like in the Phase 2b, the avolition improvement is really the key driver. Remember, we had a publication from Gregory Strauss showing that improvement of avolition was reason driver to improve overall negative symptoms. And as a consequence, PSP and at the end of the day is how the patients are functioning. So all this is really fitting together and all the analysis we are doing is fitting together.

Now to give you a complete update with all the details. I don't know when we will do this, but I think the most important is that we are really preparing and be ready for the meeting with the FDA. So we will submit the request for meeting in the next coming days because we have now all the date or most of the data together, it's now a matter to fine tune all this. And I think the best moment to give you the update is to have, obviously, the outcome of the minutes from the FDA, yes.

But I think the -- so bottom line is that we are more and more convinced that this drug is doing what it had to do. It's clear that in the Phase 3, we had this effect on placebo, which was more important than in the Phase 2b. And it's basically not a surprise us because if you have a highly positive Phase 2b study, the expectation from the PIs, the sites and even the patients or the caregiver is higher. So this is, obviously, one explanation.

We, obviously, went from 30 sites to 60 sites, and this has also an impact. But overall, when you're looking to the drug, again, to the functional consequences and from where the effect is coming, avolition with an innovative mechanism of function, I'm very confident that we will have a good meeting with the FDA. And so this is where we are and what I can tell you as of today.

Shawn Egan -- Citi -- Analyst

That's it, thank you very much.

Operator

Our next question comes from Biren Amin with Jefferies.

Jeet Mukherjee -- Jefferies -- Analyst

Yes, good morning, guys. This is Jeet on for Biren. Maybe just two from us. Remy, I guess, it looks like you're going to be scheduling this meeting with the FDA in the next couple of days.

Any idea of when that meeting might perhaps take place and when you'll come back with the feedback in hand? And second, do you believe the FDA may be willing to accept post-hoc analysis data? And are there any examples of the FDA accepting such data in the neuropsych space for a regulatory approval? Thank you.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So concerning the timing. Obviously, if we submit the document very soon, which will be the case. Usually, I mean, the time to get a meeting granted is 60 or 75 days, depending on the type of meeting you will ask for. So definitely, we will have -- how to stage the meeting and the feedback during the last quarter of -- or end of the third quarter, sorry, and we might get the feedback one month later, so third-quarter meeting and the feedback one month later.

So this is perfect life. I don't know what is the impact of COVID and the meetings that the FDA has with the sponsors. But what I heard at minimum, the things are on track, and the FDA is respecting the timetable. So again, meeting in Q3 and feedback afterwards when we have the minutes.

Now concerning your question, I mean, I think our package is not only based on post-hoc analysis. Obviously, we have done a lot of post-hoc analysis in order to better understand, for example, the placebo behavior. We have done, obviously, some post-hoc analysis in order to better quantify, for example, the effect on PSP as that to see if, I mean, PSP and negative symptoms improvements are correlated? Is evolution a driver? All what I was speaking about before. But all this is just confirming some analysis, which was scheduled in the statistical analysis plan, which has been submitted to the FDA before we did the post-hoc analysis and before, obviously, the data came out or the opening of the blind.

So I think we have in our package quite a lot of analysis, which have been done, not post-hoc, but a priori which hopefully will convince the FDA. This said, I think there are some examples, maybe not in the CNS space, but I mean, there are some examples where the FDA was giving us a green light to the sponsor to move forward based on not absolutely a p-value on the primary endpoint and some additional color which was given by post-hoc analysis. So again, I think we have a lot in our data. Again, I'm not saying that we achieved the primary endpoint at week 12, definitely not.

But all the rest of the data pointing toward the fact that the molecule is working, that the things are extremely similar to the Phase 2b. Again, remember, I showed the combination of the two studies. This will not be something the FDA will consider, but it will help. But again, long story short, I think we have enough priori analysis, which hopefully will convince the FDA.

Jeet Mukherjee -- Jefferies -- Analyst

Appreciate the color. Thank you.

Operator

Our next question comes from Thomas Shrader with BTIG.

Julian Harrison -- BTIG -- Analyst

Hi, good morning. This is Julian on for Tom. First, just keeping in mind, it's still early. Can you possibly talk about what an additional Phase 3 study for roluperidone would likely look like if that's ultimately in your best interest? Would it likely just be one dose? And could we expect a shorter study duration? Any other differences you could comment on at this time?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So first of all, again, I mean, I -- as a company and personally, having really moving forward this molecule from the beginning and try really to address this unmet medical need. And I think this is an important work that here we are dealing with unmet medical need, which has no treatment, and this is what is really making that these patients are not able to get any decent life. And they're not functioning in the family life or even not speaking about getting a small job, yes, which, obviously, would be also very important. So again, I really think that this is really what is driving us.

And can -- sorry, I missed you -- Can you repeat your question just so that I can give you the right answer?

Julian Harrison -- BTIG -- Analyst

Yes, sure. So perhaps, after you reconvened with the FDA, if it's after that meeting --

Remy Luthringer -- Executive Chairman and Chief Executive Officer

[Inaudible] study.

Julian Harrison -- BTIG -- Analyst

Can you hear me?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yeah.

Julian Harrison -- BTIG -- Analyst

So if after that meeting, it's in your best interest to proceed with an additional Phase 3 study. Can you give us a sense for what that would likely look like compared to the most recently concluded one? Would there likely just be one dose? Would there be a short duration, things like that?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So what I wanted to say is basically -- sorry, what I wanted to say is that, I mean, obviously, the best study or if we have to do a study, would be to go with one dose, definitely no extension like in this study, yes, or in the Phase 3 study we just completed. Because as you heard, we will accumulate a lot of data in terms of extension, and this will be very important in terms of also having some efficacy measurements. And we already know that things are going very well in the extension. So this definitely will be a study result, an extension.

So one dose versus placebo, definitely not two doses. But what I wanted to say and this is the reason why I started with explaining negative symptoms that avolition is a driver. We will, obviously, discuss with the FDA. If we have to do a study, we will discuss what is the best primary endpoint? What is a way to calculate negative symptoms? And how do we extract functioning? I think we did the right things.

I think the -- it's clear that, I mean, negative symptoms is a construct of different subs course. As you know, I mean, the consensus today is that negative symptoms is this 5A avolition, anhedonia, all this is part of the negative symptoms construct. And also that, I mean, it is well accepted that the Marder negative score can be subdivided into two items or into two dimensions: experience and expression. And remember, here, we had -- with experience, we had a highly significant p-value there.

So I think there will be a discussion if we have to do a study about what is the best primary and what is the best secondary endpoint. But I think, yes, you're right, it will be a much smaller study, much more straightforward study. But what would we change is because you asked me also this question. I think what we will change is definitely reduce the number of sites because I think what happened in the Phase 3 is that we really were able to, in brackets, control the sites or train the sites very well.

But I mean, maybe one or two sites did not completely do the scoring how they should have done the scoring. So we will reduce the number of sites, and we have, obviously, a lot of insight of how the sites have performed because we have also completed the analysis of the 60 sites who have participated in this study. We have also -- we went back to the analysis of all the sites, the 30 sites who have participated as a Phase 2b. So this will be the first thing to have really the right sites to really create this motivation by the sites to really score the patients not in the context but really score the symptoms of the patients because this is the essence of having a separation from placebo.

All this will be criteria we will implement in order to make sure that, I mean, we will have a successful study and discriminating placebo from treatment.

Julian Harrison -- BTIG -- Analyst

OK, got it. That's very helpful. And then, last, on seltorexant, are you aware of any plans at this time for development in the broader insomnia market beyond major depressive disorder with comorbid insomnia? Is that something you have any visibility on?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

I think we see -- as you heard, we are out of the program, and we took out royalties. Keep in mind that, I mean, the patient population, the MDD population, who will be included in this Phase 3 program run by Janssen. These are patients who have a complaint of insomnia. And as you know, insomnia is a big driver in depression.

But I mean, it's going a little bit beyond this because the insomnia will be characterized in the eligibility criteria of the patients. And in addition, insomnia, will also be quantified subjectively and objectively during the trials. So I think the insomnia part is already covered in the trial or in the trials, which will be run with the MDD population.

Julian Harrison -- BTIG -- Analyst

OK, great. Thanks very much.

Operator

[Operator instructions] Our next question comes from Jason Butler with JMP Securities.

Jason Butler -- JMP Securities -- Analyst

Hi, thanks for taking the question. Just a quick one for me. Just wondering how you think about partnering priorities for roluperidone now with this data on hand, either in the U.S. or in other global territories? Is it more of a priority? Are there things that you would consider or have you already started any discussions? Thanks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So Jason, maybe I will give over to Geoff in a minute, but I think as we discussed already in the past, I mean, we have always been open to discuss with inbounds we got from pharma companies. So as you know, I mean, as you can guess, a lot of pharma companies are completely aware about roluperidone and the development we have done, yes. But -- and we continue, obviously, to give them the updates if updates are asked for us, yes. But maybe, Geoff, you want to give more color on this.

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

Thanks for the question, Jason. There isn't really much more to add to that. We will have our discussion with the FDA, which should provide additional information to potential partners. And we'll have those discussions at that point in time.

Jason Butler -- JMP Securities -- Analyst

OK, great. Thank you.

Operator

Next question comes from Myles Minter with William Blair.

Myles Minter -- William Blair -- Analyst

Hi, guys, thanks for the questions. Just the first one on the potential differences between the placebo response and the Phase 2b and the Phase 3. Had the data for a little time now. I'm just wondering whether there's anything that's coming up in this additional data analysis that really point to the reasons why you would have seen a difference? Is it really just the difference in the quality of the clinical sites that you alluded to, Remy, that might be describing that? Or is there something else in the patient demographics that are coming up? I only asked because this is, obviously, something that you're going to be formulating an argument with the FDA about.

So just wondering any additional color as to the specific reasons why that differential response may have occurred?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yeah, so this is, obviously, a great question. And as you can guess, I mean, we worked a lot on this. And I think we have a clear understanding of what happened, yes. I mean, I was mentioning quality of scoring of some sites.

And I mean, definitely, I mean, we know that, I mean, this has or had an influence of the data. But I think what I was also mentioning the expectation after a positive study is increasing. Clearly, the patients who have been included in the study in terms of characteristics, in terms of level of negative symptoms of duration of the negative symptoms in stability, in terms of positive symptoms has definitely not change between the two studies, yes. So really, I think it is basically several things.

Again, the expectation of having an important study in hand, which has shown a very clear effect on negative symptoms, which has an influence on how the sites are scoring. There is another aspect which is important is that during the study. And we have no several reports from sites about patients who have dramatically improved and are best to work which, obviously, we will have in hand when we are going to the FDA. So really the sites could see that there is an improvement of the patients during the course of the 12-week double-blind phase.

That was toward the end of the study or toward the end of the recruitment is willingness to push the patients to the extension. Because here, obviously, you know that they are treated with 32 milligram or 64 milligram. So there are a lot of things which are explaining why we had this, what they call inflation of the placebo arm. But I think the most important of our data, and I think this is something which will be very helpful when we are going to present all this and what we will put, obviously, in a briefing book, but all what we will go to present to the FDA is to really show and demonstrate that between the Phase 2b and the Phase 3.

The improvement we have seen with 32 and more particularly with 64 milligram is the same between the two studies. We will again demonstrate that avolition is an extremely important driver. And here, the things are very, very clear. When you're looking to the data we have today in hand, and obviously, we will also more and more go into the details about PSP, yes, which, as you know, is a functional improvement.

So all these pieces are fitting extremely well together and are definitely not influenced as they have been by the placebo effect or by the placebo inflation as the primary endpoint has been influenced. And you're right, it's not really a surprise because as I tried to explain before, negative symptoms is a construct of different aspects and different dimensions. And when you're going more into the details, you see that, I mean, the Phase 3 is extremely positive and discriminating very well treatment from placebo. So this will be the full package we will present to the FDA.

Myles Minter -- William Blair -- Analyst

That's helpful. One final one from me. Just in terms of the small amount of patients that have discontinued the open-label extension study due to positive symptom relapse. Maybe in a real-world perspective, would these patients just go on adjunctive therapy with dopamine receptor blockers and they'll be managed there? Or were there something specific in these patients that they must be withdrawn from roluperidone treatment?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

I think there is nothing specific here, yes. And I'm coming to your question about add-on, yes. There is nothing specific because, I mean, keep in mind here that we have included more than 500 patients, and we have really a handful of patients who are relapsing in the double-blind phase. And there is a handful in the extension.

So when you're looking to the trials which have been run with antipsychotics, I mean, whatever you take as an antipsychotic first and second generation, when the trials are run over a period of four to six weeks, you have people who are not responding or who are relapsing on positive symptoms. So the number of relapses we see is really in line with what you see with antipsychotics. So I think our data will be extremely helpful to show to the FDA or to the CHMP in Europe. But I mean, you can have a significant amount of patients with the diagnostic of schizophrenia who do not absolutely need antipsychotics in order to stay stable in terms of positive symptoms.

Now about your question about add-on. As you know, and we discussed this in the past, we have a review of 150 psychiatrists in the U.S. And based on the target product profile, we have already a significant demand of these prescribers who are willing to give the drug in monotherapy. Obviously, some of them will still go as add-on because this is clinical practice, and it will be -- take maybe a little bit time to convince that some prescribers that there are patients out there who do not need antipsychotics.

But I think the field is evolving quite significantly. And as also we discussed in the past, there are now very, very good publications out showing that you can reduce very dramatically the doses of antipsychotics and the number of relapses will not increase. So I think the story is coming together. But again, as the data we have in hand are really showing that a lot of patients do not relapse.

And remember also when we -- when you're going with our inclusion/exclusion criteria, this represents 60% to 70% of the patients with a diagnostic of schizophrenia. So we are not speaking here about marginal population by speaking with a very, very large part of the patients with the diagnostic of schizophrenia. So again, long story short, it will need a little bit time, it will lead a little bit of education. But I think we have here a drug, which is really improving negative symptoms and functioning.

And I'm still believe and this was my hypothesis long time ago when I started this project. When you're improving negative symptoms and functioning, you probably are also improving positive symptoms or at minimum, the number of hospitalizations/relapses because the patient is more able the cope with his everyday life. So it's a paradigm shift. It is, obviously, going through a molecule, which has less side effects, which is less impairing of patients, which is really having a specific effect on negative symptoms and functioning.

So it will take a little bit time to educate as a prescriber, but I think the field is really moving into the right direction here.

Myles Minter -- William Blair -- Analyst

Fantastic. Thanks for the questions.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

You're welcome.

Operator

Our next question comes from Douglas Tsao with H.C. Wainwright.

Douglas Tsao -- H.C. Wainwright -- Analyst

Hi, good morning. Thanks for taking the questions. Just a couple for me. How are you now sort of thinking about or prioritizing some of the sort of subsequent work that we -- you are considering in terms of the ability to sort of prevent onset of the disease or sort of treating patients in the prodromal phase, as well as just now prioritizing resources in terms of some of the other assets in the pipeline and -- or is it sort of for the time being, just really focusing on getting roluperidone across the finish line? Thank you.

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

Is your line muted, Remy?

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

It's still showing Remy's line is connected.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So, can you hear me now?

Douglas Tsao -- H.C. Wainwright -- Analyst

Yeah, I can.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Sorry. Sorry, Doug. So clearly, your first question about going, for example, the prodromal patients or to prodromal -- to subject to have negative symptoms that you might transforming to a full-blown psychotic disease schizophrenia, for example. This is still something we absolutely want to do, yes, because I think that all the data we have are showing that, I mean, if you can change all this, you might maybe avoid patients who are really having the full-blown disease.

Even if they have some negative symptoms before they have the first half below the positive symptoms. So clearly, this is something we are working on, but this will be done post-approval because this is a very specific study and also a study which needs the right subjects in the study. But I mean, yes, I think earlier is better in our case or in schizophrenia. Now concerning the other assets, we have, obviously, the highest priority here on roluperidone.

We need to have a very good outcome with the FDA. And based on a positive outcome, I think the other assets can, again, start to move according to plan, yes. But I mean, the highest priority is to make sure that we have the best outcome from the FDA. And sorry about this technical issue.

I was definitely on mute.

Douglas Tsao -- H.C. Wainwright -- Analyst

Oh, no worries.

Operator

And I'm not showing any further questions at this time.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

OK, thank you all for the questions. And hopefully, it was helpful. We're, obviously, looking forward to update you very soon about the progress we have made, and I think the next major key event will be the update about what the FDA is telling us based on the data we will provide to them. So thank you again, and looking forward to give you an update very soon.

Thank you all.

Operator

[Operator signoff]

Duration: 43 minutes

Call participants:

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

Remy Luthringer -- Executive Chairman and Chief Executive Officer

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

Shawn Egan -- Citi -- Analyst

Jeet Mukherjee -- Jefferies -- Analyst

Julian Harrison -- BTIG -- Analyst

Jason Butler -- JMP Securities -- Analyst

Myles Minter -- William Blair -- Analyst

Douglas Tsao -- H.C. Wainwright -- Analyst

More NERV analysis

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