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

Good morning. A press release with the company's second quarter 2019 financial results became available at 7:30 a.m. Eastern Time today, and can be found on the Investors section of our website. Our quarterly report on Form 10-Q was also filed electronically with the Securities and Exchange Commission this morning and can be found on the SEC's website at www.sec.gov.Joining me on the call today from Minerva are Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer; Mr. Geoff Race, Executive Vice President, Chief Financial Officer, and Chief Business Officer; and Mr. Rick Russell, President. Following our prepared remarks, we will open the call for Q&A.Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption Risk Factors in our filings with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 filed with the SEC on August 5, 2019.Any forward-looking statements made on this call speak only as of today's date, Monday, August 5, 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.

Thank you, Bill, and good morning, everyone. Thanks for joining us today. The first half of 2019 has been very productive for Minerva. We announced positive top line results in two Phase 2b trials with seltorexant, Orexin-2 antagonist currently in development for two indications, major depressive disorder, MDD and insomnia.I am pleased to report that we have just obtained top line results in our first study with seltorexant. This biomarker study designated us MDD1009 was carried out in parallel with a Phase 2b trial. So top line results show improvements in symptoms of depression in MDD patients when seltorexant is given as a monotherapy. I will provide further information on these results later in the call.We have also made good progress in the enrollment of patients into our three additional late-stage clinical trials. These include the ongoing pivotal Phase 3 trial with roluperidone, a further Phase 2 trial with seltorexant for which recruitment has been completed and the Phase 2b trial with MIN-117.As you know, our mission at Minerva is to develop drugs to address unmet medical needs in patients living with serious neuropsychiatric disorders. In our lead program roluperidone we have demonstrated in the Phase 2b trial that the drug even in monotherapy showed specific improvement of negative symptoms in patients suffering from schizophrenia. To the best of our knowledge, this remains the first time such a specific effect has been shown.The recent seltorexant data also for the first time in duration class demonstrates efficacy in both adjunctive and monotherapy treatment of MDD. So let me today start with seltorexant, as we have announced significant data with this molecule over the last quarter. Seltorexant is a selective Orexin-2 receptor antagonist that we are co-developing with Janssen Pharmaceutica NV. To the best of our knowledge, seltorexant is the only late-state…

Thank you, Remy. Earlier this morning we issued a press release summarizing our operating results for the second quarter ended June 30, 2019. A more detailed discussion of our results may be found in our quarterly report on form 10-Q filed with the SEC earlier today.Cash, cash equivalents, restricted cash and marketable securities as of the June 30, 2019 were approximately $69.4 million. The company believes that its existing cash, cash equivalents, restricted cash and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months from today and into early 2021 based on our current operating plan. The assumptions upon which this estimate is based are routinely evaluated and may be subject to change.Research and Development expenses were $8.3 million in the second quarter of 2019 compared to $9.1 million in the second quarter of 2018, a decrease of $0.8 million. This decrease primarily reflects, decreased nonclinical and clinical pharmacology expenses partially offset by increased costs in the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117.For the six months ended June 30, 2019, R&D expenses were $19.9 million compared to $17.5 million for the six months ended June 30, 2018, an increase of $2.4 million. This increase primarily reflects higher development expenses for the Phase 3clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117. We expect R&D expenses to increase during 2019 as we increase patient enrollment and related support activities for the roluperidone and MIN-117 clinical trials. General and administrative expenses were $4.6 million in the second quarter of 2019 compared to $3.9 million in the second quarter of 2018, an increase of approximately $0.7 million.For the six months ended June 30, 2019 G&A expenses were $9.3 million dollars compared to $8.2 million for the same period in 2018, an increase of approximately $1.1 million. These increases in G&A expenses were primarily due to an increase in non-cash stock-based compensation expenses and salary costs from increased staffing to support our pre-commercial activities. We expect G&A expenses to increase during 2019 as we prepare for the transition of roluperidone from clinical development to commercialization.Net loss was $12.5 million for the second quarter of 2019 or a loss per share of $0.32 basic and diluted, as compared to a net loss of $12.5 million or a loss per share of $0.32 basic and diluted for the second quarter of 2018. Net loss was $28.3 million for the first six months of 2019 or a loss per share of $0.73 basic and diluted as compared to a net loss of $24.9 million or a loss per share of $0.64 basic and diluted for the first six months of 2018.Now I’d like to turn the call back to the operator for any questions.

Thank you. [Operator Instructions] And our first question comes from Joel Beatty with Citi. Your line is open.

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

Hello, Joel, I am Remy speaking. So I think, you know, as I always explained, and I think I explained this during the last earnings call, we had, I mean it was the last study we are reading out and I assume is a study which is a comparison over a period of six months between our molecule and quetiapine which is the standard of care to treat patients who are not responding adequately to SSRIs or as SNRIs.So this is really, I mean, mostly a study which is a study to really better understand how the things are comparing between standard of care and our molecule, obviously in terms of safety, because as you know quetiapine is an antipsychotic and has always the side effects of antipsychotics and really also to have some long-term data with our molecule.So I think it will not change as a basic plan of the Phase 3 or the registrational [ph] studies will be the same, but I mean, having in addition the data from this 2002 study coming, it will help us to really fine tune the plan in order to really demonstrate the added value of our molecule compared to standard of care. So, again, important study, but it does not change, you know, where we are going, yes.

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

So, as you know I mean, what we have discussed with the FDA at the end of Phase 2 meeting is to do our best efforts to come as close as possible to 30% of the patients coming from the U.S. As of today the things are quite in line with these numbers, but I mean it’s obviously not 30% exactly, but I mean it is very well in line, yes.Now, concerning your second question, yes indeed, I mean, as you know I’m a big fan of checking the quality of the data, comparing the data from country to country, from site to site and because the U.S. is - if you want - the only difference between the Phase 2b and the Phase 3, because in the Phase 2b we only had European sites, I’m obviously carefully following what is going on in the U.S. and I have to say that I am really very reassured about the results, because when we are analyzing our data, obviously completely blinded, so I don’t know what is going on between placebo and treatment, but completely blinded, the U.S. is performing as well as Europe.And I think, you know, I was always concerned about the way these patients are recorded in the U.S. because we are dealing here with negative symptoms, you need to check the stability of the negative symptoms over a certain period of time before including the patients. But once the patients are in the study, I think in the U.S. as the sites are doing a great job in assessing the symptoms of the patient. So, again I mean, we have more screen fails, so less patients who are included into study, but once the patients are in the study I think we cannot see any difference between U.S. and Europe which is extremely reassuring for the outcome of the study.

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

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

Great, thank you.

Thank you, Joel.

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

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

So, great-great question obviously, and I think the good problem we have here is that we have no another options here, because this is really a very nice demonstration that I mean the drug has a direct effect on mood. Yes, I mean, it's really confirming what we have seen before. But, I mean, this is the first time we are doing a study in monotherapy.And so, I think it does not really change our view, yes, because what it confirms and we are continuing to work on analyzing additional data coming out from this data -- from this study, excuse me, because we are looking to cortisol, we are looking to some aspects, which are you know, able to detect arousals, which are able to detect stress and we will learn more about some mechanism of action.But basically with all the data we have today are confirming, you take the add-on data in depression, you take this monotherapy data in depression, you take our data in insomnia, are showing that this is a very innovative mechanism of action. And I'm really insisting on this, because if you compare this to dual antagonist, this is not a dual, it's the same profile. And interestingly enough, I mean, in our case, we cannot discriminate in terms of side effects from placebo. So we have a very-very good safety profile.So I think it is just confirming what we were thinking, how the drug is working. And it gives us even more confidence, in fact what we are doing moving forward in Phase 3 will be successful, yes. But it does not change anything in terms of thinking, in terms of development plan.

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

Exactly. You're completely right.

And does that gives you incremental sort of thought to using it as a - testing it as a monotherapy or do you continue to think, at least in depression it would be more than as a common - you know, as an adjunctive therapy?

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

Okay, great. Thank you so much, Remy.

You are welcome.

Thank you. [Operator Instructions] We have a question from Jason Butler with JMP Securities. Your line is open.

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

Jason, I was expecting this question, great question. So, clearly, I mean, 20 mg is crystal clear, so as you have seen, we have exactly the same results in monotherapy as the results we have seen in add-on. So 20 mg is and will remain as the cornerstone dose. We are still working on better understanding what is going on with 40 mg. A lot of work is currently on going. We're trying to understand how the free fraction of the drug is impacting the results.So we are really working very hard on this 40 mg data. In other words, I mean to be more precise, we are already working on checking if there is a dose dependent or an exposure dependent effect on mood and things are still ongoing. And I think based on this data, which will probably be available very soon, and we will sit together with our colleagues from Johnson & Johnson, we will decide if the Phase 3 will be - is one dose or with two doses, including 40 mg.So stay a little bit with us and I think during the next quarter I can give you complete clarity of where we are going. But again, 20 mg is definitely confirmed to be the cornerstone dose. And as you have seen, also for insomnia, 20 mg is an important dose. This side, you have also seen that with 10 mg we have a very-very nice effect on insomnia. So obviously with insomnia we are also contemplating lower doses than 20 mg. But again, stay with us for two or more weeks and I will give you the complete clarity on where we are going.

Great, very helpful. Thanks for taking the question.

Thank you.

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

Hi, guys. Thanks for taking my questions. Remy, on roluperidone Phase 3 trial; can you just talk about the read-throughs from the recent Acadia study that has failed?

Yes. So thank you for the question. I think it's very complicated to draw some conclusions from the Acadia study. Because as you have seen, I mean, the Acadia study is a study where the drug has been given on top of antipsychotics for -- in patients who are not responding well to antipsychotics. The score of these patients entering the study was quite high on the PANSS scale and so the study design is completely different for obviously what we are doing. And this study was not stratified, for example, in terms of negative symptoms.I know that there is another study coming soon from our colleagues from Acadia where the minimum score of negative symptoms, but again, it will be add-on to antipsychotics. So, I mean, long story short, I think we cannot – I have to say, draw any conclusions from the study concerning our trial, yes. Obviously there is something in common, which is the 5-HT2A antagonism or inverse agonist, which by the way is getting the same pharmacological effect.What it means is that the 5-HT2A component is definitely contributing to help in terms of controlling positive symptoms. It might also have small beneficial effect for example, on cognition. It has definitely an effect on sleep. So clearly, I mean, what this data tell me is that 5-HT2A is important, but not enough in order to really move the needle in terms of negative symptoms and cognition and I mean, when you look into our drug, it is very-very clear that, I mean, the effect is driven by the synergistic or the combination of 5-HT2A antagonism and Sigma2 antagonism. So, again, interesting, important data, but we cannot really conclude based – or to expand to our data.

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

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

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

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

Great, thank you.

Thank you so much.

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

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

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