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Minerva Neurosciences Inc (NERV 5.08%)
Q4 2019 Earnings Call
Mar 9, 2020, 8:30 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Welcome to the Minerva Neurosciences Year End 2019 Conference Call. [Operator Instructions]
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 B. Boni -- Vice President, Investor Relations/Corporate Communications
Good morning. A press release with the company's year end 2019 financial results and business highlights became available at 07:30 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 -- at 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 09, 2019. Any forward-looking statements made on this call speak only as of today's date, Monday, March 09, 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 & Chief Executive Officer
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 readout 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 3 study with roluperidone MIN-101 and we were delighted to announced completion of enrollment in early February. I'm looking forward to announcing top-line 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 improve 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 3 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 the Marder negative symptoms factor score. Secondary endpoints includes a 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 has the option to continue receiving their original dose and patients on 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 3 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 abolition 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 neuropsychiatric 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 we seltorexant. Three of these trials were in major depressive disorder, MDD, and one was in insomnia disorder. In a nutshell, the results shows 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 3 strategic development with a target indication of adjunctive treatment of MDD. The discussions include development strategy and financial considerations related to the Phase 3 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 2 meeting with FDA to discuss the design of Phase 3 studies, and we expect to share details related to these studies later this year.
Finally, we are making significant progress in the pre-clinical development of MIN-301, a soluble recombinant form of the neureglin-1 beta 1 or r NRG-1b1 protein for the treatment of Parkinson's disease and other neurodegenerative disorders. We believe MIN-301 has a potential to target brand deficits and in so doing to slow the onset off and restores a brain tissue damage caused by this neurodegenerative diseases. Pre-clinical toxicology and other IND-enabling studies are ongoing. Pendings or completion, we anticipate submitting regulatory filings in the U.S. or Europe so that if approved will allow us to move to this compound forward into men.
We believe 2019 was an overall success based on the roluperidone and seltorexant achievements, I have described. So completion of patient enrollment marks a major milestone in the Phase 3 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. Results are 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 -- 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 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 may be 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 loss per share of $0.34 basic and diluted. Net loss was $72.2 million for the year ended December 31, 2019 or loss per share of $1.85 basic and diluted compared to a net loss of $50.2 million or 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.
Questions and Answers:
Operator
Thank you. [Operator Instructions] Our first question comes from Jason Butler with JMP Securities. Your line is now open.
Jason Butler -- JMP Securities -- Analyst
Hi. Thanks for taking the question. Just wanted to revisit one of the discussion topics from your KOLs on Friday and the potential for roluperidone in other indications that involve negative symptoms. Can you just maybe speak to how the different components of the assessments of negative symptoms that may read through to other indications and how you think roluperidone could impact those components? Thanks.
Remy Luthringer -- Executive Chairman & Chief Executive Officer
Hello Jason. Remy speaking here. So obviously a great question, 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 abolition 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 or 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 patent.
I think last but not least, and we did not discuss this extensively in our KOL event. I think roluperidone has a fraction to be really effective in other indications like neurodegenerative disorders, like Alzheimer or Parkinson's disease because remember, we have this extremely significant increases of BD&L GDNF which is definitely helping in terms of neuroplasticity and may be neurorestoration.
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 just together, I think we can be extremely confident that it works also in other indications.
Jason Butler -- JMP Securities -- Analyst
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 of the NDA and the non-clinical, pre-clinical portions? And is there anything other than the clinical components of the submission that would be time gating following Phase 3 results to NDA submission? Thanks.
Remy Luthringer -- Executive Chairman & Chief Executive Officer
Yeah, Jason. So the short answer is, there is no limiting factor because we are extremely advanced in the preparation of the NDA filing and obviously we need to have the clinical data. 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 pre-clinical 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 we can say this very loud and clear, we are completely ready outside obviously, waiting for the clinical data.
Jason Butler -- JMP Securities -- Analyst
Great. Thank you for taking the questions. And we're excited to see the data soon. Thanks.
Remy Luthringer -- Executive Chairman & Chief Executive Officer
Thank you, Jason.
Operator
Thank you. Our next question comes from Douglas Tsao with H.C. Wainwright. Your line is now open.
Douglas Tsao -- H.C. Wainwright -- Analyst
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 is any sort of steps being taken to offset any impact of the coronavirus on the execution of the Phase 3 trial for roluperidone? And then 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 -- Executive Chairman & Chief Executive Officer
Thank you. So again, great question. So concerning the coronavirus, so to be very clear and to briefly address this because you were also at our event 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 recruit 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 example which is shipped to the different labs. So really in the ongoing patients we have no problem because we always have a spec sample. So this is clearly under control.
And last but not least, keep in mind that I mean in 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 heavy 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 you know because we have this opportunity to go into different indications outside schizophrenia, we had to make some to make some choices and we started to make the choice to open an IND in apathy and dementia. Of course, a very simple reason is that when you're looking to the symptoms, when you're looking to what is going on into the -- in the brain of these patients, if it is an Alzheimer patient or may be a Parkinson's patient or rather dementia, you know it seems that, I mean we 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 this 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 the children who are suffering from autistic disorders, for example. And we are definitely discussing with some of these associations who are taking care of this autistic children. So we are really open to all the different possibilities, but I think this takes a little bit more times. 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 -- H.C. Wainwright -- Analyst
Okay, great. Thank you so much. That's helpful.
Operator
Thank you. Our next question comes from Joel Beatty with Citi. Your line is now open.
Shawn Egan -- Citi -- Analyst
Hi. 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 has 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% drop out 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 there are electing to transition to the open-label extension portion of the study? Thank you.
Remy Luthringer -- Executive Chairman & Chief Executive Officer
Sure. Great question. So clearly, I mean to really restate of extremely, extremely well. To get to the stage of the NDA and to get hopefully get 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 plants. So this is really what you need.
So clearly, we will do some additional analysis as we have done post-talk [Phonetic] with the Phase 2b in order to see if it confirms the fact that the age has 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 a dollar cents at risk who have not developed as a complete disease. But I mean we can also think about the 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, indeed. Obviously, if I mean we reconfirm 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, the Phase 3 study below the 40% drop out. So we are completely I have 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 -- Citi -- Analyst
Yeah. What percentage of patients are electing to do transition to the open-label extension portion of the trial?
Remy Luthringer -- Executive Chairman & Chief Executive Officer
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 a lot, who will complete the extension. Remember that in the Phase 2b study we were at around 80 person, if my memory is not completely wrong who went into the extension and you can sing along these lines for the Phase 3.
Shawn Egan -- Citi -- Analyst
Great. Thank you very much.
Remy Luthringer -- Executive Chairman & Chief Executive Officer
Which, if you allow me a small comment, is a great surrogate about how well patients are and how well caregivers think about what they see with a drug is. So it's really I think a very nice surrogate and decorating.
Shawn Egan -- Citi -- Analyst
Great. Thank you.
Operator
Thank you. Our next question comes from Biren Amin with Jefferies. Your line is now open.
Biren Amin -- Jefferies -- Analyst
Yeah, 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 crossover from placebo to active?
Remy Luthringer -- Executive Chairman & Chief Executive Officer
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 was on the placebo. But clearly obviously when people are going into the extension, everybody is treated with 32 milligram or 64 milligram, again obviously no clue if they are on 32 or on 64 milligram. So it's single blind, but I mean nevertheless it's blinded for the dose. And 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 this is a lot of the sites. So it was a little bit dangerous to come up with this story. But because it's blinded and you never know, 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 the 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 reengaged with families and some of them have even the job and they are still in the jobs.
To be very clear, I have more and more positive pressure from some PIs so what makes of one year of treatment, because the patients are going so well. So obviously, we are in Phase three. So we cannot provide more than this. But clearly I mean incredible feedbacks of some patients who have really recover this basically. So it's obviously not general. It's not -- all the patients and I do not know obviously the history all of the patients, but some of the feedbacks are really, really very, very positive and very encouraging.
Shawn Egan -- Citi -- Analyst
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. So those that went on to open-label extension, how many -- clearly, it's -- 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 drop-out?
Remy Luthringer -- Executive Chairman & Chief Executive Officer
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 because this might evolve over time. But as of today, there are not a lot of dropouts in the open-label phase as we had. So you can compare to -- also to the double-blind phase, sorry, I did not try my word.
So basically, there is not a lot of dropouts 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 I will give you more granularity maybe next time as we speak. But it looks extremely good. 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, so 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 I have the data even double-blind -- completely blinded study. I mean you know how many patients are relapsing. It is really, really a handful patients who are relapsing.
So I think what is becoming more and more clear in the clinical and scientific communities that there is a significant population out there who does not relapse once they are not treated with antipsychotics. And this is what we are demonstrating more and more. Let us wait the end of the study, let us analyze the data. We will have a very, I think large sample. And I think this will overall beyond roluperidone to think differently.
There is a paper out recently, a very small study and 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 2 higher doses of antipsychotic.
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 for the people who will prescribe roluperidone, but I think it goes beyond. Roluperidone it goes really above the understanding of how to treat best patients suffering from schizophrenia.
Shawn Egan -- Citi -- Analyst
Okay. Thank you. Thanks for taking my questions.
Remy Luthringer -- Executive Chairman & Chief Executive Officer
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 -- William Blair -- Analyst
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 Marder 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 talk to on Friday as well?
Remy Luthringer -- Executive Chairman & Chief Executive Officer
Incredible question. So for the moment, obviously, when -- 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 plants negative score. 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 is 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 the data, but I don't have the information as of today. 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 is -- there are differences, regional differences and there are no regional differences, which is also extremely, extremely good including the U.S. which is extremely good.
I agree with you that the PANSS is definitely not a best tool because -- and this is a 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 stat scales are already showing exactly the same effect of our drug, which is very, very reassuring and a very good outcome here.
So we have lots of BNSS in the Phase 3, but what I can tell you is that we confirm at 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 the Marder negative score out of the PANSS for this very simple reason which has been discussed also Friday in this KOL day, KOL breakfast, which is at G16 is a different, is a main difference between what we have used in the Phase 2b and the Phase 3 and this is really giving you an additional hint toward I'll say, the way patients are starting to behave again with the families and with their environment. So all in all, I mean clearly, it is the PANSS you have to use. And second, things are really going into the right direction.
Myles Minter -- William Blair -- Analyst
No, that's helpful. And then last, maybe changing tracks from roluperidone. The seltorexant opportunity, we've had a chance to see the day they go Lemborexant label firm exhausted approval earlier this year. Just wondering your updated thoughts on the opportunity there 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 change? And then maybe a quick one for Geoff. There is $15 million left on the balance sheet for you 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 -- Executive Chairman & Chief Executive Officer
Thanks. I will take the first question, and I'll quickly hand over to Geoff. So definitely seltorexant I think is a completely unique molecule for insomnia and 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 Orexin-2 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 our molecule is that it means the half life of the molecule is short, but the PKPD is really a spot on. So basically, we really see the pharmacodynamic effect basically helping people to stay asleep for the times as the seven hours as 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 figure it was a very, very structured study with deepening the Phase 2b to be. 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 dual antagonist, Rexim antagonist service. So as of today, it's an extremely promising drug for insomnia indication.
But maybe Geoff, I give over to two for the second question.
Geoff Race -- Executive Vice President, Chief Financial Officer and Chief Business Officer
Thanks Remy, and thanks for the question, Miles. 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 so 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 MIN-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 -- William Blair -- Analyst
Great. Thanks for the clarification. Cheers guys.
Remy Luthringer -- Executive Chairman & Chief Executive Officer
Thank you.
Geoff Race -- Executive Vice President, Chief Financial Officer and Chief Business Officer
Thank you.
Operator
Thank you. This concludes today's question-and-answer session. I would now like to turn the call back over to Remy Luthringer for closing remarks.
Remy Luthringer -- Executive Chairman & Chief Executive Officer
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 not becoming more and more aware that negative symptoms are really something important in schizophrenia, but not only much beyond schizophrenia. And with all the questions you have asked, I think this is clarifying more and more things. So really thank you again for your participation. And I'm looking forward to updating you on the progress in a very near future. So thank you again and have a nice day. Bye.
Operator
[Operator Closing Remarks]
Duration: 44 minutes
Call participants:
William B. Boni -- Vice President, Investor Relations/Corporate Communications
Remy Luthringer -- Executive Chairman & Chief Executive Officer
Geoff Race -- Executive Vice President, Chief Financial Officer and Chief Business Officer
Jason Butler -- JMP Securities -- Analyst
Douglas Tsao -- H.C. Wainwright -- Analyst
Shawn Egan -- Citi -- Analyst
Biren Amin -- Jefferies -- Analyst
Myles Minter -- William Blair -- Analyst
