Minerva Neurosciences, Inc. (NERV) CEO Remy Luthringer on Q4 2019 Results - Earnings Call Transcript

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q4 2019 Earnings Conference Call March 9, 2020 8:30 AM ET

Company Participants

William Boni - Vice President of Investor Relations & Corporate Communications

Remy Luthringer - Executive Chairman & Chief Executive Officer

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

Conference Call Participants

Jason Butler - JMP Securities

Douglas Tsao - H.C. Wainwright

Shawn Egan - Citi

Biren Amin - Jefferies

Myles Minter - William Blair

Operator

Welcome to the Minerva Neurosciences Year End 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 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 of Investor Relations and Corporate Communications at Minerva. Please proceed.

William Boni

Good morning. A press release with the company's year-end 2019 financial results and business highlights became available at 7:30 AM. Eastern Time today, and can be found on the Investors section of our website. Our Annual Report on Form 10-K 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. Rick Russell, President; 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 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 Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 9, 2019. Any forward-looking statements made on this call speak only as of today's date, Monday, March 9, 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

Thank you, Bill and good morning everyone. Thanks for joining us today. Minerva's mission is to develop innovative therapies to meet the significant unmet medical need, faced by patients suffering with schizophrenia, depression, sleep disorders and neurodegenerative disorders such as Parkinson's disease. Last year, we took significant steps to achieving our goals. I'm pleased to report, that 2019 was a landmark year for Minerva, as we read out positive data in three Phase 2b studies with seltorexant in patients with MDD and insomnia.

In addition, we made great progress in recruiting over 500 patients into the Phase III study with roluperidone, MIN-101 and we were delighted to announce completion of enrollment in early February. I'm looking forward to announcing topline results of roluperidone study in the second quarter of this year. We believe these results have the potential to transform the therapeutic landscape for schizophrenia. Recently, a number of imminent researchers have highlighted how roluperidone, if approved, could successfully treat a significant percentage of patients with schizophrenia, suffering from negative symptoms and cognitive impairment.

Among emerging therapies in development for negative symptoms, roluperidone is the most clinically advanced. To the best of our knowledge, roluperidone is the only therapy, having shown today, a specific and direct improvement of negative symptoms. Interestingly, further data analysis of our Phase 2b study shows that patients also improved in terms of cognition, mood and functioning, thus further demonstrating what we believe are the unique qualities of this agent.

Last month, we announced the completion of enrollment in the ongoing pivotal Phase III trial with roluperidone as monotherapy for the treatment of negative symptoms in patients diagnosed with schizophrenia. The final total of 515 patients have been enrolled, compared to our original goal of 501 patients. The trial which is being conducted at clinical sites in the U.S. and Europe is a randomized, double-blind, parallel-group placebo-controlled, 12-week study to evaluate the efficacy and safety of 32-milligram and 64-milligram doses of roluperidone as measured by the positive and negative syndrome scale.

The primary endpoint is a Marder negative symptoms factor score. Secondary endpoints include the personal and social performance scale and clinical global impression of severity. Patients are being randomized 1:1:1 to the 32-milligram and 64-milligram doses of roluperidone and placebo. The core 12-week double-blind phase of the trial is followed by a 40-week open-label extension period during which patients on the drug have the option to continue receiving their original dose and patients with placebo may receive one of the two doses of roluperidone.

Top line results for the 12-week, double-blind portion of the trial are expected in the second quarter of 2020. An intensified focus on negative symptoms has emerged in the KOL community since the results of the roluperidone Phase 2b trial were announced and since the Phase III trial was initiated. A total of seven peer-reviewed publications have been published since our Phase 2b data became available, showing the unique and specific effect of roluperidone on improving negative symptoms, an effect that translates into both cognitive improvements and functional improvements.

Most recently, for example, we hosted a KOL breakfast last week during which, researcher Dr. Gregory Strauss discussed his recent study published in schizophrenia bulletin. Results of a network analysis of our Phase 2b data with roluperidone by Dr. Strauss team showed that the successful treatment of the core negative symptom of [evolution] [ph] defined as reductions in the desire for and initiation of motivated behavior is a key driver of the overall improvement of other negative symptoms of schizophrenia.

We believe that negative symptoms are a feature of a number of neuropsychotic disorders, that may be attractive targets for the future transdiagnostic clinical development of roluperidone and we have recently filed an IND to prepare for a clinical study for the treatment of apathy in dementia.

I would like to move on to seltorexant, our second clinical stage product and the development with Janssen Pharmaceutica for the treatment of insomnia disorder and major depressive disorder, MDD. During 2019, we announced positive data readouts of three Phase 2b trials and one Phase 1b trial with seltorexant. Three of these trials were in major depressive disorder MDD and one was in insomnia disorder.

In a nutshell, the results show that seltorexant has positive effects on insomnia patients without comorbidity, including elderly patients with a favorable safety profile. In MDD, patients not responding adequately to SSRIs and SNRIs, seltorexant also shows improvements in mood particularly in patients with insomnia. We and Janssen are currently in discussions regarding Phase III strategic development with a target indication of adjunctive treatment of MDD.

These discussions include development strategy and financial considerations related to the Phase III program and the timing of payments following the achievement of defined milestones under our agreement. We and Janssen are also currently consulting with the U.S. Food and Drug Administration FDA and the European Medicines Agency, EMA about this target indication. We recently attended the end of Phase II meeting with FDA to discuss the design of Phase III studies and we expect to share details related to the studies later this year.

Finally, we are making significant progress in the preclinical development of MIN-301, a soluble recombinant form of the Neuregulin- 1β1or NRG-1β1 protein for the treatment of Parkinson's disease and other neurodegenerative disorders. We believe MIN-301 has a potential to target brain deficits and in so doing to slow the onset of and restores the brain tissue damage caused by this neurodegenerative diseases.

Preclinical toxicology and other IND-enabling studies are ongoing. Pending the completion, we anticipate submitting regulatory filings in the U.S. or Europe that, if approved, will allow us to move to this compound forward into [indiscernible]. We believe 2019 was an overall success based on the roluperidone and seltorexant achievements I have described. The completion of patient enrollment marks a major milestone in the Phase III trial with roluperidone.

I would like once more to thank all the patients, clinical investigators, external consultants and the Minerva clinical team, who conducted and participated in this trial. Without their commitment we would not be standing at the threshold of a potentially transformative data readout in the coming months.

I will now turn it over to Geoff.

Geoff Race

Thank you, Remy. Earlier this morning, we issued a press release summarizing our operating results for the fourth quarter and year ended December 31, 2019. A more detailed discussion of our results may be found in our quarterly report on Form 10-K filed with the SEC earlier today.

Cash, cash equivalents, restricted cash and marketable securities as of December 31, 2019 were approximately $46 million compared to $88.1 million as of December 31, 2018. We presently expect that the company's existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months from today and into mid-2021 based on our current operating plan. The assumptions upon, which this estimate is based are routinely evaluated and maybe subject to change.

Research and development expenses were $28.5 million in the fourth quarter of 2019 compared to $9 million in the fourth quarter of 2018. R&D expenses were $58.1 million for the year ended December 31, 2019 compared to $34.9 million for the year ended December 31, 2018. The increase in R&D expenses during the fourth quarter and the year ended December 31, 2019, primarily reflects a $19 million non-cash impairment expense for the discontinued development of MIN-117 and higher development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117.

General and administrative expenses were $3.8 million in the fourth quarter of 2019 compared to $4.6 million in the fourth quarter of 2018. G&A expenses were $17.7 million for the year ended December 31, 2019 compared to $16.8 million for the year ended December 31, 2018. This increase in G&A expenses during the fourth quarter and the year ended December 31, 2019 was primarily due to an increase in non-cash stock-based compensation expenses and higher professional fees to support pre-commercial activities.

Net loss was $29.9 million for the fourth quarter of 2019 or loss per share of $0.77 basic and diluted compared to net loss of $13.2 million for the fourth quarter of 2018 or a loss per share of $0.34 basic and diluted. Net loss was $72.2 million for the year ended December 31, 2019 or a loss per share of $1.85 basic and diluted compared to a net loss of $50.2 million or a loss per share of $1.29 basic and diluted for the year ended December 31, 2018.

Now, I'd like to turn the call over to the operator for any questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first question comes from Jason Butler with JMP Securities. Your line is now open.

Jason Butler

Hi. Thanks for taking the question. Just wanted to revisit one of the discussion topics from your KLO event on Friday and the potential for roluperidone and other indications that involve negative symptoms. Can you just maybe speak to how the different components of the assessment of negative symptoms that may read through to other indications and how you think roluperidone could impact those components? Thanks.

Remy Luthringer

Hello, Jason, Remy speaking. Yes. So – and obviously, a great question, yes. And I think it was a very interesting discussion during this event. But clearly I mean, I think what is shown in the literature is that [evolution] [ph] is definitely a driver in a lot of conditions.

I mean, people losing this drive and this ability to get involved in any activity is really a key driver. So really I mean, there are a lot of data in favor of having our drug working in other indications. When you're looking also to some work which has been done for example in depression, now in mood disorders compared to patients in schizophrenia with negative symptoms you see the same brain structures basically activated. So there is really a common path between what you see in schizophrenia and depression for example.

So I'm not saying that it is completely overlapping but I think there is a common path. And I think last but not least and we did not discuss this extensively in our KLO event is that I think roluperidone has a [fraction] [ph] to be really effective in other indications like neurodegenerative disorders like Alzheimer's or Parkinson's disease because remember we have this extremely significant increases of BDNF, GDNF, which is definitely helping in terms of neuroplasticity and maybe neurorestoration.

Yes. So when you put all the pieces together, I think roluperidone can be really seen as a very transdiagnostic molecule, not only for negative symptoms but also for cognition probably and as you – if you remember the very early data we have also seen effects on sleep. So when you put all this together I think we can be extremely confident that it works also in other indications.

Jason Butler

Okay. Great. And then just one more for me. In terms of the non-clinical components of the NDA submission. Can you speak to where you are in things like the CMC component as the NDA and the non-clinical, preclinical portions? And is there anything other than the clinical components of the submission that would be time gating following the Phase III results to NDA submission? Thanks.

Remy Luthringer

Yes, Jason. So the short answer is there is no limiting factor yes, because we are extremely advanced in the preparation of the NDA filing. And obviously, we need to have the clinical data, yes but for the rest I mean the things are really moving according to plan.

We are extremely well advanced in terms of CMC. We are – we did a very, very, very careful review of all the preclinical data. We have even – because some data – or the guidelines have changed over time. So we have repeated some data to be according to the most recent guidelines. So I think I can say this very loud and clear. We are completely ready outside obviously waiting for the clinical data.

Jason Butler

Great. Thank you for taking the questions and we’re excited to see the data soon. Thanks.

Remy Luthringer

Thank you, Jason.

Operator

Thank you. Our next question comes from Douglas Tsao with H.C. Wainwright. Your line is now open.

Douglas Tsao

Hi, good morning. Thanks for taking the questions. Just first, just given all the news Remy just if you could provide an update if there's any sort of steps being taken to offset any impact of the coronavirus on the execution of the Phase III trial for roluperidone?

And then a second question for me, just curious if you could walk through the thinking in terms of choosing apathy as the next indication to pursue for roluperidone, just given, what seems to be very broad potential for a number of psychiatric conditions with this molecule? Thank you very much.

Remy Luthringer

Thank you. So again a great question. So concerning the coronavirus. So to be very clear and to briefly address this because you were also at our events on Friday. So we really take this extremely seriously and we have really checked the situation with our CROs. And as of today, this morning – this morning I have checked again with the clinical team. And as of today, we have all the patients in the study with all the visits done. So as of today there is no impact at all.

But I mean in a more broader way, I think people have to understand that we are in an extremely I think a favorable situation. Why? Because first, all the patients are recruited. So in other words, we don't need response from whatever clinical lab from whatever biological lab, but in order to get results in order to include the patients, because everybody is in the study. And as you know, we took really very carefully the things in terms of getting two samples at the site and one sample which is shipped to the different labs. So really in the ongoing patients, we have no problem because we always have a spare sample. So this is clearly under control.

And last but not least, keep in mind that I mean most of the study of course it's a complete study it's an outpatient study. And the patients are only coming to psychiatric hospitals or to clinical facilities dealing with psychiatry to do their visits. And clearly, the psychiatric hospitals are not involved in having patients coming with symptoms of coronavirus. So when you put all this together, I think we can be extremely confident. And last but not least, we have already a lot of patients who have completed the double-blind phase. And definitely, we are ticking the box of the number of patients we need. So I think we take it seriously. We have to follow what is going on, but it's really under control.

Now concerning your second question, yes, I mean because we have this opportunity to go into different indications outside schizophrenia. We had to make some choices. And we started to make the choice to open an IND in apathy and dementia, because a very simple reason is that when you look into the symptoms, when you look into what is going on into the -- in the brain of these patients, if it is an Alzheimer patient or maybe Parkinson patients or another dementia, it seems that I mean we're also ticking the boxes here that roluperidone can work. This said -- and I mean at the end of the day to confirm that I mean we are true. This is not a big study. We have to run to get the data we need and afterwards to move ahead.

But obviously, there are other indications which are important like for example mood disorders. There are other indications, which are also important like I think children who are suffering from autistic disorders for example and we are definitely discussing with some of these associations who are taking care of these autistic children. So we are really open to all the different possibilities. But I think this takes a little bit more time. This needs maybe a little bit more broader study. So we have decided to be pragmatic to start somewhere, but this does not mean that we will not jump into other indications. So it's a step-wise approach and a very pragmatic approach.

Douglas Tsao

Okay, great. Thank you so much. It's helpful.

Operator

Thank you. Our next question comes from Joel Beatty with Citi. Your line is now open.

Shawn Egan

This is Shawn Egan calling in for Joel. Thanks for the update today and also for taking my questions. On the Phase 3 -- I know the trial is enrolled -- to enroll subjects 18 to 55 years old, but are there any target age distribution that you're hoping to achieve in that study? And then also on the Phase 3 the 40% dropout assumption. Can you comment on whether on a blinded basis, you've been in line with that assumption? And also on what percentage of patients are electing to transition to the open-label extension portion of the study? Thank you.

Remy Luthringer

Sure. Great question. Yes. So clearly, I mean to really restate the things extremely well. To get the -- to the stage of the NDA and to get hopefully as the things approved by the FDA, what you have to do is to show that the overall study. So from 18 to 55 years of age that I mean you show a p-value on the Marder negative score out of the PANSS. So this is really what you need. Yes. So clearly, we will do some additional analysis as we have done post hoc with the Phase 2b in order to see if we confirm the fact that the age has an effect -- on the effect size, we are not speaking here about p-values, we are speaking about the effect sizes. And this will obviously be done, but this is not at all related to what we need in order to get the drug approved. But we will definitely do it because more speaking with KOLs, more speaking with clinicians, it is true that I mean one of the sweet spots of roluperidone would be to really go after even adolescents risk who have not developed as a complete disease. But I mean we can also think about first episode patients where you have really I think with a drug like roluperidone an extremely good chance to completely reverse the course of the disease.

So, yes, it did obviously -- is -- I mean we reconfirmed that the effect size in the younger population or the younger part of the patients who are in the Phase 3 are showing an effect size. Remember, it was above 1.5 in terms of effect size in the younger part of the population. We will definitely think about running a trial really concentrating on this younger population.

So, now and more practically I mean to your questions. Definitely I mean we are in the study it's a Phase 3 study below the 40% dropout. So, we are completely how to say ticking the box. And I have to say that I forgot the last point you asked me. You asked me about the percentage. Can you please help me? What was the last question?

Shawn Egan

Yes, what percentage of patients have elected to transition with the open-label extension portion of the trial?

Remy Luthringer

Okay. So, we have never disclosed this, but I can tell you that there is an important amount of patients who have been transitioned into the extension and we have already a significant amount of patients who have completed the 12 months. So, it looks like that we will have a lot of patients going into the extensions and the lots who will complete the extension.

Remember that in the Phase 2b study, we were at around 80% if my memory is not completely wrong went into the extension and you can think along these lines for the Phase 3

Shawn Egan

Great. Thank you very much.

Remy Luthringer

--which if you allow me -- small comment is a great surrogate about how well patients are and how well caregivers think about what they see with the drugs. So, it's really I think a very nice surrogate and accreting.

Shawn Egan

Great. Thank you.

Operator

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

Biren Amin

Yes, hi. Thanks for taking my questions. So, Remy on the open-label extension, what anecdotes can you provide on the patients that have completed it, especially, those patients that crossed over from placebo to active?

Remy Luthringer

So, first of all, I mean I don't know who crossed over from placebo to active because the study is blinded. So definitely I have no clue who goes on the placebo, yes. But clearly obviously when people are going into the extension everybody is treated with 32 or 64-milligram again. Obviously, no clue if they are on 32 or on 64 milligrams. So, it's single blind but I mean nevertheless it's blinded for the dose. So, -- but clearly over the last nine months I mean the patients are definitely treated.

So, as you know I have visited most of the sites, all the sites, my colleague, Michael Davidson has also visited a lot of the sites. It's always a little bit dangerous to come up with these stories, yes, but -- because it's blinded. And you never know yes. But I can tell you that I mean there are some spectacular feedbacks I get by visiting the sites where I mean you have patients who had negative symptoms, no drive basically evolution and negative symptoms.

And for years and in the trial and after few weeks of treatment, they start to be really, really interested in what is going on around them. They reengaged in real social life. They reengage with families and some of them have even a job, yes and they are still in the jobs.

To be very clear, I have now more and more positive pressure from some PIs to what next after the one-year of treatment because the patients are going so well. So, obviously, we are in Phase 3, so we cannot provide more than this. But clearly I mean incredible feedbacks of some patients who have really recovered this basically. So, it's obviously not general. It's not all the patients. And I don't not know obviously that's historical patients, but some of the feedbacks are really, really very, very positive and very encouraging.

Biren Amin

And on the open-label, you mentioned, it's similar to the Phase 3 -- Phase 2b in that 80% went on to open-label extension. But -- so those that went on to open-label extension, how many -- clearly you're still in the process of completing the study, but of the patients that completed the open-label extension versus those that dropped out during the open-label extension. Can you just comment on the percentage of dropouts?

Remy Luthringer

I cannot -- I can obviously, I have the numbers, but I think as of today, it would be not fair to give you any percentage, because I mean we have not enough patients who have completed compared to the patients ongoing. So you have to be a little bit patient to get the final number, yes, because this might evolve over time, yes.

But as of today there are not a lot of dropouts in the open-label phase as we had -- and as I say you can compare to -- also to the double-blind phase -- sorry, I did not find my word, yes. So basically, we have not a lot of dropout in the open-label phase as of today, but again, still a lot of patients in the open-label phase. So it would not be fair to give you a percentage as of today. So stay with us a little bit and we'll give you more granularity maybe next time as we speak, yes.

But it looks extremely good, yes. And if you allow me to be a little bit more specific, people are always struggling and not later than on Friday when we had this KOL there, again, I received a question. Why placebo is reacting in the way it is reacting in your study? And why do you not have more people relapsing than what you had in the Phase 2b and I can tell you that it's a Phase 3, because obviously here is the data even double-blind -- completely blinded study. I mean, you know how many patients are relapsing, it is really, really a handful of patients who are relapsing.

So I think what is becoming now more and more clear in the clinical and scientific communities that there is a significant population out there who does not relapse when they are not treated with antipsychotics. And I think this is what we are demonstrating more and more.

Let us wait at the end of the study, let us analyze the data. We will have a very I think a large sample. And I think this will overall beyond roluperidone has a scientific and clinical community to think differently. There is a paper out recently a very small study, and I'm happy to share this with everybody, showing that I mean when you are comparing patients who are at the recommended therapeutic doses of antipsychotics and you compare them to a population where you're titrating down the antipsychotics, there is no more relapse in the titrated-down population. And obviously, the patients are functioning extremely well compared to higher doses of antipsychotics.

So I think the space is really moving. The space is asking themselves the right questions. And I think this will be at the end of the day for the benefit of roluperidone, as people who will prescribe roluperidone, but I think it goes beyond roluperidone. It was really about the understanding of how to treat best patients suffering from schizophrenia.

Biren Amin

Okay. Thank you. Thanks for taking my questions.

Remy Luthringer

You’re more than welcome.

Operator

Thank you. [Operator Instructions] Our next question comes from Myles Minter with William Blair. Your line is now open.

Myles Minter

Hi, guys. Just a question on the Evolution. I find that data really interesting. Wondering whether the baseline severity and incidence rates of evolution in the Phase 2b is being matched in the Phase 3 trial that will get data up soon? And also I'm curious as to if changes in evolution are best captured by the modest negative factor symptom score? Or whether you really do need to use a scale like the brief negative symptoms scale, which I know your KOLs talked to on Friday as well?

Remy Luthringer

Incredible question, yes. So for the moment, obviously, we as you know, we -- and this is even ICH guidelines are telling you to do this. I mean, basically we are comparing the pool of patients completely blinded from the Phase 2b study with a pool of patients we have in the Phase 3 study in terms of the PANSS negative scores. So -- but this we are speaking here about the overall scores. And what is extremely clear from the data we have as of today, so comparing again blinded data from the two studies.

The starting -- or the entry score or the negative score is very similar between the two studies. And there's a time course over the first 12 weeks we are monitoring very carefully. Obviously it's a double blind phase, the time course of decrease of negative symptoms is exactly the same. So this is what we have and what we are monitoring on a regular basis.

Going to the granularity of evolution, as of today I don't have the data. Maybe my head of R&D has a data, but I don't have the information as of today yes. But clearly I mean, the overall behavior of the negative score coming out from the PANSS is definitely going into the same direction. And interestingly enough, obviously, I wanted to know if there are differences -- regional differences. And there are no regional differences, which is also extremely, extremely good yes, including the U.S., so which is extremely good.

No. I agree with you that the PANSS is definitely not the best tool because -- and this is the reason why people were coming up with newer scales more specifically how to say analyzing negative symptoms like the BNSS. As you know we did the analysis because we had as a secondary endpoint we have the BNSS in our Phase 2b study and it has even been published. And interestingly enough, the two scales are really showing exactly the same effect of our drug yes, so which is a very, very reassuring and a very good outcome yes.

So we have lots of BNSS in the Phase 3. But what I can tell you is that we confirm that the end of Phase 2 meeting with the FDA what is the scale to be used and the scale to be used as of today is still the PANSS and that's the reason why we have the PANSS. We have decided as you know to go with a Marder negative score out of the PANSS for this very simple reason, which has been discussed also Friday in this KOL day or KOL breakfast, which is at -- G16 is a different -- is the main difference between what we have used in the Phase 2b and the Phase 3. And this is really giving you an additional hint towards I'll say the way patients are starting to behave again with the families and with their environment yes. So all-in-all, I mean clearly it is unsafe to use and second things are really going into the right direction.

Myles Minter

Cool. That's helpful. And then maybe changing tracks from roluperidone. The seltorexant opportunity we've had a chance to see the DAYVIGO, lemborexant open-label after approval earlier this year. Just wondering your updated thoughts on the opportunity there? And in insomnia, is it still about the day one efficacy lack of next day sleepiness value proposition there? Or have your thoughts for that product changed?

And then maybe a quick one for Geoff. There's $15 million left on the balance sheet for your -- in process research and development. I gather that's all related to Janssen and the seltorexant program there. When can we expect that to be realized? Cheers.

Remy Luthringer

Thanks. I will take first the first question and I quickly would hand over to Geoff. So definitely seltorexant, I think is a completely unique molecule for insomnia in the ecosystem of what is currently developed with the orexin pathway in mind.

So really I think for insomnia, the specificity of seltorexant as you know we are the only molecule best of my knowledge in development -- clinical development or in well advanced clinical development, which is a specific vaccine to antagonist. And I think this makes a complete difference in terms of efficacy and in terms of safety compared to dual antagonists.

We have another attribute, which is I think extremely important with other molecule is that it means the half-life of the molecule is short. But the PK/PD is really spot on, yes. So, basically, we really see the pharmacodynamic effect, so basically helping people to stay asleep.

For the times there's a 7 hours, there's a 7.5 hours you need in order to have a good night of sleep and to be able to perform adequately during the day. And, I mean, I think, it was a very, very instructive study we did in the Phase 2b. So, first of all, well powered. I'm speaking here about the study in, what we called in the past, primary insomnia, so patients who have no other comorbidities.

And we really did a very nice study, I think, enough patients, also having a significant sample of elderly patients in the study. And even in the elderly patients, clearly, the drug is doing the job in terms of efficacy and zero impairment compared to what you might see with the GABAergic molecule or what you might see with a dual antagonist orexin antagonist. So, as of today, it's an extremely promising drug for insomnia indication. But maybe, Geoff, I give over to you for the second question.

Geoff Race

Thanks, Remy, and thanks for the question, Myles. You correctly observed that $19 million non-cash impairment charge was incurred in quarter four and that related to the in-process R&D that we had on the balance sheet for MIN-117 and that relates to the data that we saw in November-December time following the 2b study in MDD patients with anxiety.

But you rightly, also, observed that, that leaves about $15 million on the balance sheet of in-process R&D assets. And actually that relates to MIN-301. And, obviously, that went on to the balance sheet back in 2013 when we acquired the company that owned the 301 asset. That doesn't get amortized until the asset is commercialized. So that will sit on the balance sheet for a little while longer.

Myles Minter

Great. Thanks for the clarification. Cheers, guys.

Geoff Race

Thank you.

Remy Luthringer

Thank you.

Operator

Thank you. This concludes today's question-and-answer session. I would now like to turn the call back over to Rémy Luthringer for closing remarks.

Remy Luthringer

Yes. Thank you so much. So, really thank you all for listening today and also for the great questions, because, I think, it's always important to have this kind of questions because, yes, indeed -- I mean, it's true that, I think, people are now becoming more and more aware of that negative symptoms are really something important in schizophrenia, but not only much, much beyond schizophrenia. And with all the questions you have asked, I think, this is clarifying more and more of the things. So I really thank you again for your participation and I'm looking forward to updating you on the progress in a very near future, yes. So thank you, again, and have a nice day. Bye.

Operator

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