Minerva Neurosciences Inc (NERV) Q4 2018 Earnings Conference Call Transcript

NERV earnings call for the period ending December 31, 2018.

Motley Fool Transcribers
Motley Fool Transcribers
Mar 12, 2019 at 12:53PM
Health Care
Logo of jester cap with thought bubble.

Image source The Motley Fool.

Minerva Neurosciences Inc  (NASDAQ:NERV)
Q4 2018 Earnings Conference Call
March 12, 2019, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

See all our earnings call transcripts.

Prepared Remarks:

Operator

Welcome to the Minerva Neurosciences Year-End 2018 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 -- Vice President, Investor Relations and Corporate Communications

Good morning. A press release with the company's year-end 2018 financial results 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 SEC 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 31st, 2018 filed with the SEC on March 12th, 2019.

Any forward-looking statements made on this call speak only as of today's date Tuesday March 12th, 2019, and the company disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after today's call except as required by law.

I would now like to turn the call over to Remy Luthringer.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Thank you, Bill, and good morning, everyone. Thanks for joining us today. Minerva is enrolling patients in five clinical trials with three product candidates. Each product has a potential to contribute meaningfully to the treatment of its respective target indication.

For roluperidone we are conducting a Phase 3 study in schizophrenia specifically is a negative symptoms associated with the disease. For seltorexant we are conducting three Phase 2b studies in major depressive disorder and insomnia. For MIN-117, we are engaged in a Phase 2b trial in anxiety depressive disorder. In addition, we continue to work on strategic research and development of each of our molecules, which will inform our future regulatory and commercialization strategy.

I would like to first discuss our lead compound roluperidone also known as MIN-101. Roluperidone is a subject of an ongoing pivotal Phase 3 trial as monotherapy for the treatment of negative symptoms in patients diagnosed with schizophrenia.

This multi-center, randomized, double-blind, placebo-controlled, 12-week study is designed to evaluate the efficacy and safety of 32 milligrams and 64 milligrams of roluperidone in other patients suffering from schizophrenia.

So , 12-week study is followed by a 40-week open label optional extension period during which patients on active drug during the double-blind phase will continue receiving the original dose. And patients on placebo during the double-blind phase will receive as a 32 milligrams or 64 milligrams of active drug.

The primary endpoint is a change from baseline in negative symptoms using the positive and negative syndrome scale PANSS, Marder's negative symptoms factor score, NSFS, over the 12-week double-blind treatment period.

Briefly I will describe the main patient inclusion criteria which include diagnosis of schizophrenia as defined by DSM-5. Baseline score of equal or superior to 20 points on the 7 PANSS negative items. Manifestation and symptomatic stability of negative and positive symptoms for six months prior to enrollment as judged by the principal investigator age between 18 and 55 years.

Please note that scores of equal or superior to 20 points on the negative subscale reflect moderate severity of the disease and scores ranging between 20 and 30 points covers the majority of individuals suffering from schizophrenia.

Therefore, we believe that the patients included in our Phase 3 and Phase 2b studies have a range and severity of symptoms also experienced by a significant proportion of patients diagnosed with schizophrenia. To quantify this and based on an extensive literature review, and our own survey of 150 psychiatrists. So, populations that might benefit from roluperidone is approximately 780,000 patients in the US.

A recent research report published by Decision Resources Group, DRG, confirms that roluperidone represents a large market opportunity. Our study design and endpoint selection have been informed by insights gained in the recent Phase 2b trial, and continuous dialog with the FDA. We are working closely with approximately 60 clinical sites in the US and Europe to ensure adherence to critical aspects of the conduct of the study.

For example, we are working to minimize rating variability among clinical sites by carefully assessing on a regular basis throughout the study intra and inter-rater variability, which is kept as low as possible. Achieving this goal, we hoped to produce the same separation between roluperidone and placebo observed in the Phase 2b study.

We expect completion of enrollment during the first half of 2019, and top line results from the 12-week double-blind period in mid 2019. In parallel, with the conduct of the Phase 3 study, we are working on key activities. The results of which will be integrated into our MDA submission package. This include, for example, clinical pharmacology trials and CMC scale-up.

Furthermore, we are working with the input of several KOLs on post-approval studies in schizophrenia and beyond. With respect to the ladder, research has shown that negative symptoms are present not only in schizophrenia, but in 18 additional diseases described in the DSM-5 classification of psychiatric disorders.

Finally, we continue to expand our understanding of the mechanism of action of roluperidone. This mechanism of action appears to be unique not only in targeting new pathways like Sigma2, but also in increasing the release of BDNF, Brain-Derived Neurotrophic Factor, which may have a positive effect on neuroplasticity for example.

Seltorexant is our second clinical-stage products under development with Janssen Pharmaceutica for the treatment of insomnia disorder and major depressive disorder, MDD. Three Phase 2b trials are ongoing with seltorexant two as adjunctive therapy to antidepressants in MDD, and one as monotherapy in insomnia disorder.

Previous clinical findings have indicated the treatment with seltorexant has resulted an improvements in depressive symptoms and sleep respectively. In the first MDD trial designated as 2001 trial enrollment of 287 patients has been completed at sites in the US, Europe, Russia, and Japan.

We expect top line results in the second quarter of 2019. In the second MDD trial designated as 2002 trial, approximately 100 patients have been enrolled in clinical sites in the US. We expect top line results in mid-2019. The insomnia trial designated as the 2005 trial is expected to enroll approximately 360 patients at sites in the US, Europe and Japan. We expect top line results in mid-2019.

Moving onto MIN-117. We are recruiting patients with MDD who also have symptoms of anxiety thus building upon earlier clinical observations of effects in both depressive symptomatology and anxiety. In addition to the primary endpoint of reducing the symptoms of major depression, we plan to assess anxiety cognition and sexual function to further defines the product profile of MIN-117 as an adjunct that can potentially address shortcomings associated with existing therapies for MDD.

Approximately 324 patients are expected to be enrolled in this study at approximately 40 sites in the US and Europe. We expect top line results in the first half of 2019. Finally, we are developing a preclinical candidate MIN-301, a soluble recombinant form of the neuregulin-1 beta-1 or NRG-1 beta-1 protein for the treatment of Parkinson's disease.

We believe MIN-301 has the potential to be disease-modifying in patients suffering from Parkinson's disease and potentially other neurodegenerative disorders. Preclinical toxicology and other IND-enabling studies are ongoing. Pending the completion, we anticipate submitting regulatory filings in the US or Europe that, if approved, will allow us to move this compound forward into the clinic.

In summary, our goal in 2019 is to realize a significant opportunities presented by the five late-stage clinical trials I have described. Towards that end, our clinical mandate is to ensure adherence to all aspects of trial protocols from patient selection to data governance. Our entire R&D team is focused on this objective. In parallel, we are also working on MDA preparatory work market positioning and commercialization planning.

I would now turn it over to Geoff.

Geoffrey 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 31st, 2018. 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 31st, 2018 were approximately $88.1 million compared to $133.2 million as of December 31st, 2017. We 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 late 2020 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 $9 million in the fourth quarter of 2018 compared to $6.5 million in the fourth quarter of 2017.

R&D expenses were $34.9 million for the year ended December 31st, 2018 compared to $30.3 million for the year ended December 31st, 2017. The increase in research and development expenses during the fourth quarter and year ended December 31st, 2018 primarily reflect higher development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117.

During the year ended December 31st, 2018 these amounts were partially offset by lower development expenses for the seltorexant program due to the amendment to our co-development and license agreement with Janssen.

General and administrative expenses were $4.6 million in the fourth quarter of 2018 compared to $3 million in the fourth quarter of 2017. G&A expenses were $16.8 million for the year ended December 31st, 2018 compared to $10.9 million for the year ended December 31st, 2017.

The increase in general and administrative expenses was primarily due to an increase in non-cash stock-based compensation expenses and salary costs from increased staffing to support our pre-commercial activities. Net loss was $13.2 million for the fourth quarter of 2018 or loss per share of $0.34 basic and diluted compared to net income of $0.2 million for the fourth quarter of 2017, or income per share of $0 basic and diluted.

Net loss was $50.2 million for the year ended December 31st, 2018, or a loss per share of $1.29 basic and diluted compared to a net loss of $31.5 million or a loss per share of $0.83 basic and diluted for the year ended December 31st, 2017.

The net income reported for the fourth quarter of 2017 is the result of tax reform legislation enacted on December the 22nd, 2017 commonly known as the Tax Cuts and Jobs Act. This act resulted in significant modification to existing law as a result benefit for income taxes was $9.4 million in the fourth quarter of 2017 compared to zero in the fourth quarter of 2018.

Benefit for income taxes was $9.4 million for the year ended December 31st, 2017 compared to zero for the year ended December 31st, 2018.

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


Related Articles

Questions and Answers:

Operator

Thank you. (Operator Instructions) Our first question comes from the line of Jason Butler of JMP Securities. Your line is open.

Jason Butler -- JMP Securities -- Analyst

Hi. Thanks for taking the questions. I just had two. First on roluperidone. Can you just give us a little bit more insight into the assessment of rate of variability and how well you think it's working. Are you seeing what happens when you see higher rates of variability than you would like to. And then secondly for seltorexant and the MDD trials. Can you just give us a little bit more color on the patient population being enrolled in those two trials? Thanks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yes. So, Jason, with pleasure. So, for the first question, as you know, I mean, this is my favorite topic, how to minimize the variability among rates, Jason. And I think we discussed this already in some previous calls. I think the essence is to have as a PI and his team in the driver seat. Jason, to really before you start any inclusion of any patient, of any assessment, of any patient you really need to bring them on speed and you need to try to explain them exactly what you're trying to achieve, Jason. And I think this is what we have achieved. We have really created a lot of proximity with the sites, proximity in the sense that, I mean, we are sharing the same objective and we are sharing the same understanding of the disease and how we have to assess the disease. Coming to this variability and the assessment how we're doing it.

So, basically in this trial we have such kind of tablet where the raters are putting in the -- online the scales and, yes, indeed, I mean, if I mean there is something which is inconsistent or where I mean it needs to be prompted to the rater, it pops up immediately, and the rater can really reassess a patient and maybe change his mind knowing that he is in the driver seat and he has a final decision on all this.

So, this is, I think, the most important to know of what we are doing is indeed, yes, I mean on a continuous basis, we have obviously completely blinded. We have the feedback of the different rating scales and particularly the pump scale. And, yes, well, I mean someone is outside, somehow is a normal distribution of the raters, we ask to reassess the site.

We retrain the site and we bring them back somehow to the normal distribution. So, this is something, which I think is extremely important. I can tell you that, I think, we did our job very well at the beginning before starting the study because we don't have to do a retraining as we speak. So, I think, this is really very nicely under control.

So, this is one aspect, as you know, of controlling what is going on, again, not controlling the type of patients, but controlling is a correct assessment, because last point maybe because I start to be long, but last point, which is important in our case, as you know, our drug has no side effects, which are allowing you to pick up the drug.

So, you're really having exactly the same safety profile as for placebo. And so in essence to pickup the therapeutic effect of our molecule is really based on raters who are extremely objective who are really trend to pick up as a signal because again you can definitely not pick up our drug from placebo.

Concerning seltorexant. So, the MDD trial, we are running or which we are or what I would say is the population we are targeting with this depression trials are really patients who are not responding well to existing therapies.

So, basically patients are not responding to antidepressants like SSRIs and SNRIs. And I mean if this is confirmed, I mean, they really have only partial response to the treatment. What is proposed to them is to enter into the trial and what you're doing, you're comparing different doses of seltorexant versus placebo. In order to see, if I mean, you can improve these patients who are not -- have not responded well to existing antidepressant. So, it is really on top of an antidepressant that you're doing as a study.

And, as you know, I mean, I think, this is an incredibly large unmet medical need. Yes, because today is the only treatment we have to help the partial responders is to help them with low doses of antipsychotic, the dopamine-blocking molecules.

And I think there is an improvements, there is no doubt about this in these patients in terms of mood. But the patients have really a lot of side effects. So, I think, there is a real unmet medical need there. And last point, keep in mind, that it is well described that in the depressed patient population a lot of these patients have insomnia.

Yes, and to have a molecule which not only is improving in insomnia, but also have a direct effect on mood without the side effects of the antipsychotics, which is currently the standard of care for partial responders. I think this is really addressing a completely unmet medical need. So, this is what we are doing in our studies basically, Jason.

Jason Butler -- JMP Securities -- Analyst

Great. Very helpful. Thanks for taking the question and looking forward to all of the readouts in the coming months. Thanks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Coming soon.

Operator

Thank you. Our next question comes from the line of Joel Beatty of Citi. Your line is open.

Joel Beatty -- Citigroup -- Analyst

Hi. Good morning, and thanks for taking the questions. The first one is just on the timing for the different clinical trial results coming. Obviously there's several readouts all like mid-year or end of the first half or beginning of the second half. Could you just narrow it down maybe tell us the order to the extent be available of it and maybe the timing of the next results?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So, Joel, I can definitely give you the order. So, clearly, as a first data which will come out on seltorexant. So, and I think what will first come out is the trial dealing with depression. Afterwards, we will have very soon, afterwards, we will have data coming on the insomnia trial with seltorexant, and this is quite concomitant with data on the Phase 2b with 117, and a little bit later, we will have the data on the Phase 3 for 101. So this is the order of data readout basically.

Joel Beatty -- Citigroup -- Analyst

Okay, great. And then for seltorexant, I think, that's an co-development with Janssen. Can you talk about, I guess, a few points of that collaboration or one being how you decided to share the data with the data come the top line data will be coming from Janssen or Minerva. Another question would be, who decides on kind of the design of the Phase 3 program and then also how is cost sharing for that Phase 3 program?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So, I will take the first part, and maybe I give over to Geoff for the financial aspects -- the economic aspects. So, clearly, I mean, when the data will come out when we will have the top line results and all the results.

I mean, what is planned is that, I mean, there's two teams, I mean, the Johnson & Johnson team and the Minerva team are sitting together and we go through all the data because, I think, as there is definitely a lot of expertise on the two sides of the table.

And I think this has been since the beginning we have really exchanged a lot about what is the best design of moving forward and what is the best studies in the two indications we are following. So, clearly, I mean, this will be a common effort to get the maximum out of the data, which will come out.

So, this is the way we are doing it. But your question about Phase 3 clearly, as you know, we have a joint steering committee and a joint development committee. And I mean here we will debate what will be the best design moving forward say I mean maybe Geoff you can give a little bit more granularity of how the things are organized in terms of economics.

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

Sure. In terms of the Phase 3, obviously, there's just one joint steering committee. But as we move into Phase 3 and that design process is well under way as we speak. But in Phase 3, Minerva has responsibility decision making responsibility for the design and the execution of the Phase 3 in insomnia. J&J will contribute an amount of $40 million to the cost of the insomnia study. J&J has the decision making authority for the MDD study in Phase 3 and we share the costs of the MDD study on a 60, 40 basis where Minerva takes 40% of the cost of the Phase 3.

Joel Beatty -- Citigroup -- Analyst

Great. And then maybe one last question on the clinical trial results that are coming. First from the trial of seltorexant with depression. What would you see as successful results? What are you looking for from that trial?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So, we're -- always looking for, how to say, a P value, but I mean not only us, because how this study has been designed. It is really to finally confirm what is the best dose moving forward. So, as you know, in this trial, we had -- we have -- initially we have 20 milligram, 40 milligram and potentially 10 milligram versus placebo.

And again, I mean, this is really a study, which is designed in order to really have the maximum of information to select the right dose moving forward. So, this is really the purpose. But, again, I mean, and, I mean, speaking about how we are functioning together with our friends from Johnson & Johnson.

We decided at the end of the day to have this study powered correctly in order to get the P value. Yes, and we are definitely expecting to see a P value here. So, for me a positive study is definitely having a P value and having a very nice discrimination between one of the doses or some of doses versus placebo.

Yes, and as you know, when you're looking to the current meta analysis of what is the difference, what is the delta between placebo and existing therapies speaking about peer obviously about SSRIs, SNRIs for example, you know, the difference is hardly reaching two points different that's between 2 and 2.5 points difference.

So, obviously, I'm also looking to what is the size of difference between placebo and the different treatment also different doses, because this is also important. Keep in mind just that, I mean, here we are in a quite specific situation because we are giving our molecule on top of antidepressants, and we are dealing here with the patient population who is not responding well to existing therapies.

So, I means, the reference we have here is a little bit less important, but I mean nevertheless, I mean, to see a very nice delta between placebo and treatment is extremely important, but I'm also looking for is to look to the safety profile, as I explained before to answering Jason's question is that, I think, we have really here an unmet medical need in terms of efficacy for this patient population, for this sub population of patients in the ecosystem of depression.

But we have also, we need also a better safety profile and maybe a drug doing something on mood and on sleep. So, I mean, I think it's a very rich study with a lot of secondary endpoint. And I think we will learn a lot, sorry, in order to design the best study moving forward.

Joel Beatty -- Citigroup -- Analyst

Great. Thank you.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

You're welcome.

Operator

Thank you (Operator Instructions) Our next question is from the line of Biren Amin with Jefferies. And your line is open.

Biren Amin -- Jefferies -- Analyst

Yes. Hi, guys. Thanks for taking my questions. Maybe just to start on roluperidone, Remy. I think you talk about site quality extensively. Can you just provide us what your experience has been so far in the Phase 3 trial. Have you had any site quality issues, if so how those been addressed? Thanks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So, I think, I'm extremely relaxed about this one. Yes, and I know that we had a lot of debate you and me about this one, when we started I was always a little bit concerned about integrating some US sites, because I mean this sites are more commercially oriented and have a little bit less knowledge about the history of the patient.

I think we did a good job and I think we won also by being very interactive with the sites. We won credibility and the sites are really understanding what we try to achieve. So, I really think that I mean we have currently around 60 sites all around the US and Europe are doing a great job. So, data will tell us but I'm feeling very comfortable as we speak.

Biren Amin -- Jefferies -- Analyst

Got it. And then on the MIN-117 program with the Phase 2b and depression. I think you're looking at patients that also have anxious to stress with moderate and severe depression. So, can you just help us think about what we should expect on the matter score, which is the primary endpoint for the trial. What would be clinically relevant and proven? Is it still the two point improvement that you referenced earlier for the SSRI, SNRI. Is that the bar or is that something different?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So, it's obviously a very, a great question. So, again, yes, I mean at minimum we need to achieve this whatever two point differences. Yes, I mean there is no doubt about it. I obviously hope based on the knowledge we have about the drug.

And the doses we're using in this trial. So, keep in mind, that in this trial we are using 2.5 milligram and 5 milligram in the small Phase 2a trial, we were using 2.5 and the lower dose. So I'm really expecting that, I mean, we will see a more important difference here in terms of difference between placebo and treatments and two points.

This is definitely clear. But so I think this trial is also important to teach us about those dependent effects clearly between 2.5 milligram and 5 milligram because you know that this is the pharmacology of MIN-117 is quite rich or complex pharmacology and I think by increasing the exposure you are probably hitting a little bit more pathways in the brain and very important pathways to get a very good response. And, obviously, one of the -- some of these pathways, sorry, are also involved in controlling anxiety.

So, I'm really also hoping to see something in anxiety, and just to give a little bit clarity for people who are listening is that we have, obviously, as a classical inclusion criteria for depression. But we have a minimum score is terms of anxiety.

So, as the patients need really to have a minimum score in terms of anxiety. But, last but not least, our bottom line, what I'm hoping is definitely to see a significant effect because the studies is powered to show a P value.

I hope to see something which is more important for depressions and a two points different, but two points would already be good. But, I mean, I'm hoping for more, but what is also important is again thinking about the side effect profile or the additional activities of the molecule not only speaking about the anxiety, but speaking about the cognition, speaking about the overall level of tolerability of the drug.

Because I think that this drug has a real positioning as a chronic treatment in depressed patients. Yes, I think, we have no -- it's quite interesting that the dynamic going on in the space of mood disorders. We have no, a lot of drugs, who are addressing very acute phases of the disease, as you know, yes, I mean, and these drugs are extremely important.

But, I mean, I think, you cannot really think about giving them long-term, and you have really a patient population out there who needs a drug, which is extremely well tolerated, is keeping the efficacy in terms of mood, and is improving cognition, is improving sexual function, is improving anxiety levels, and I think this is exactly where we are trying to position 117 and the data will tell us, this Phase 2b will tell us, and we will design of Phase 3 accordingly.

Biren Amin -- Jefferies -- Analyst

Would you at some point evaluate with this compound sort of comparing it to benzodiazepines, which you tend to be more prescribed for anti-anxiety purposes in the US?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So, by having worked in benzodiazepines since the first one came out at work. So, I mean, I think that the benzodiazepines are extremely good treatments. But like always people are not using them in the right way. Yes, and definitely benzodiazepines are extremely good for acute anxiety, for example, but are not good for generalized anxiety disorders, because you have the problem of tolerance, you have the problem of rebound effect. So, clearly there is still a very, very, very important unmet medical need about treating generalized anxiety disorders. If our data are really good in terms of anxiety, I'm not saying that we have decided because it's, I mean, our decision is always data driven, but I mean if the date are extremely good in terms of anxiety. I'm not excluding the fact that I mean we will also have some source about having studies going on in anxiety.

Biren Amin -- Jefferies -- Analyst

Got it. And actually one last question back on roluperidone. If the Phase 3 is positive when could we expect that you would file the MDA and are there any other small Phase 1 studies that you need to complete before you file the MDA and post Phase 3 completion.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yes. So, great question. So, definitely, I mean as we speak we are working intensively on the MDA preparation, yes, because you have -- it's a big, big piece of work, as you know, yes. And I think the team is really doing a great job on this and I have to say that it is looking extremely good. So, they say that you're right, I mean, we need to complete the DDI package.

So, we are currently doing some additional DDI studies in order to really have the full understanding of the molecule when we have the readout of the Phase 3 study, the efficacy study. So, yes, indeed we are working on this. We are also working on some additional preclinical studies, which are needed in order to file the MDA.

But I mean all this work will be completely ready when we have the readout of the Phase 3 study. So, afterwards, as you know, I mean, we will do our best efforts to get as quickly as possible to the stage of discussing with the FDA, how we hired this MDA and how we move forward to give you a complete exact timing, I think, it's a little bit too premature.

Biren Amin -- Jefferies -- Analyst

Got it. Thank you.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

You're welcome.

Operator

Thank you. And at this time there are no further questions. I would like to turn the conference back over to Mr. Remy Luthringer for the closing remarks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yeah, thank you so much, and thank you for everybody for your participation of -- on today's in today's call. And I'm really looking forward to give you updates on all this important readouts coming soon for Minerva. Thank you so much.

Operator

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

Duration: 38 minutes

Call participants:

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

Remy Luthringer -- Executive Chairman and Chief Executive Officer

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

Jason Butler -- JMP Securities -- Analyst

Joel Beatty -- Citigroup -- Analyst

Biren Amin -- Jefferies -- Analyst

More NERV analysis

Transcript powered by AlphaStreet

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.