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Edited Transcript of NERV earnings conference call or presentation 12-Mar-19 12:30pm GMT

Q4 2018 Minerva Neurosciences Inc Earnings Call

Cambridge Mar 18, 2019 (Thomson StreetEvents) -- Edited Transcript of Minerva Neurosciences Inc earnings conference call or presentation Tuesday, March 12, 2019 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Geoffrey Robin Race

Minerva Neurosciences, Inc. - Executive VP, CFO, Chief Business Officer & Company Secretary

* Rémy Luthringer

Minerva Neurosciences, Inc. - Executive Chairman & CEO

* William B. Boni

Minerva Neurosciences, Inc. - VP of IR & Corporate Communications

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Conference Call Participants

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* Biren N. Amin

Jefferies LLC, Research Division - MD and Senior Equity Research Analyst

* Jason Nicholas Butler

JMP Securities LLC, Research Division - MD and Senior Research Analyst

* Joel Lawrence Beatty

Citigroup Inc, Research Division - VP & Analyst

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Presentation

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Operator [1]

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Welcome to the Minerva Neurosciences Year-End 2018 conference call. (Operator Instructions) 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.

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William B. Boni, Minerva Neurosciences, Inc. - VP of IR & Corporate Communications [2]

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Good morning. A press release with the company's year-end 2018 financial results became available at 7:30 a.m. 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. Rémy 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, 2018, filed with the SEC on March 12, 2019.

Any forward-looking statements made on this call speak only as of today's date, Tuesday, March 12, 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 Rémy Luthringer.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [3]

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Thank you, Bill, and good morning, everyone. Thanks for joining us today. Minerva is enrolling patients in 5 clinical trials with 3 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 III study in schizophrenia, specifically, the negative symptoms associated with the disease. For seltorexant, we are conducting 3 Phase IIb studies in major depressive disorder and insomnia. For MIN-117, we are engaged in a Phase IIb trial in anxious 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 tragedy.

We would like to first discuss our lead compound roluperidone, also known as MIN-101. Roluperidone is a subject of an ongoing pivotal Phase III trial as monotherapy for the treatment of negative symptoms in patients diagnosed with schizophrenia. This multicenter, 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 either 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 6 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 a majority of individuals suffering from schizophrenia. Therefore, we believe that the patients included in our Phase III and Phase IIb 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, the populations that might benefit from roluperidone is approximately 780,000 patients in the U.S.

The 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 IIb trial and continuous dialogue with the FDA. We are working closely with approximately 60 clinical sites in the U.S. 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 helped reproduce the same separation between roluperidone and placebo observed in the Phase IIb 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 III study, we are working on key activities, the results of which will be integrated into our NDA submission package. This include, for example, clinical pharmacology trials and CMC scale-up. Furthermore, we are working with input of several KOLs on postapproval studies in schizophrenia and beyond.

With respect to the latter, 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 product under development with Janssen Pharmaceutica for the treatment of insomnia disorder and major depressive disorder, MDD. Three Phase IIb trials are ongoing with seltorexant, 2 as adjunctive therapy to antidepressants in MDD and 1 as monotherapy in insomnia disorder.

Previous clinical findings have indicated that treatment with seltorexant has resulted in improvement 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 U.S., 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 U.S. We expect top line results in mid-2019.

The insomnia trial designated as 2005 trial is expected to enroll approximately 360 patients at sites in the U.S., 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 define 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 U.S. 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-1b1 or NRG-1b1 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 their completion, we anticipate submitting regulatory filings in the U.S. 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 the significant opportunities presented by the 5 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 NDA preparatory work, market positioning and commercialization planning.

I would now turn it over to Geoff.

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Geoffrey Robin Race, Minerva Neurosciences, Inc. - Executive VP, CFO, Chief Business Officer & Company Secretary [4]

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Thank you, Rémy. Earlier this morning, we issued a press release summarizing our operating results for the fourth quarter and year ended December 31, 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 31, 2018, were approximately $88.1 million compared to $133.2 million as of December 31, 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 31, 2018, compared to $30.3 million for the year ended December 31, 2017. The increase in research and development expenses during the fourth quarter and year ended December 31, 2018, primarily reflect higher development expenses for the Phase III clinical trial of roluperidone and the Phase IIb clinical trial of MIN-117.

During the year ended December 31, 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 31, 2018, compared to $10.9 million for the year ended December 31, 2017. The increase in general and administrative expenses was primarily due to an increase in noncash stock-based compensation expenses and salary costs from increased staffing to support our precommercial 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 share of $0 basic and diluted. Net loss was $50.2 million for the year ended December 31, 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 31, 2017.

The net income reported for the fourth quarter of 2017 is the result of tax reform legislation enacted on December 22, 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 0 in the fourth quarter of 2018. Benefit for income taxes was $9.4 million for the year ended December 31, 2017, compared to 0 for the year ended December 31, 2018.

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

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Jason Butler of JMP Securities.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [2]

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I just had 2. 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 2 trials?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [3]

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Yes, Jason, with pleasure. And so for the first question, as you know, this is my favorite topic how to minimize the variability among rate assessment. 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 is to really before you start any inclusion of any patient and 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, yes. 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 we are sharing the same objective and we are sharing the same understanding of the disease and -- of how we have to assess the disease. Now coming to this variability and the assessment how we are doing it. So we are -- basically, in this trial, we have such kind of tablet where the raters are putting in online the scales and yes, indeed -- if there is something which is inconsistent or where it needs to be prompted to the rater, it pops up immediately and the rater can really reassess the patient and maybe change his mind knowing that he is in the driver seat and he has the final decision on all of this, yes. So this is, I think, the most important -- what we are doing is indeed -- yes, on a continuous basis, we have obviously completely blinded. We have the feedback of the different rating scales and particular is the PANSS scale. And yes, when someone is outside somehow the normal distribution of the raters, we ask to reassess this 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 retraining as we speak. So I think, this is really very nicely under control, yes. So this is one aspect, as you know, of controlling what is going on. Again, not controlling the type of patients, but controlling the 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 pick up the therapeutic effect of our molecule is really based on raters, who are extremely objective, who are really trying to pick up the signal, yes, because, again, you can definitely not pick up our drug from placebo. Concerning seltorexant, so the MDD trial, we are running, which we're -- the population we are targeting with this depression trials are really patients who are not responding well to existing therapies. So basically, patients who are not responding to antidepressants like SSRIs and SNRIs. And if this is confirmed, 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 you can improve these patients, who are not -- have not responded well to existing antidepressants. So it is really on top of an antidepressant that you're doing the study. And as you know, I think this is an incredibly large unmet medical need, yes, because today, the only treatments we have to help partial responders is to help them with low doses of antipsychotics, so dopamine-blocking molecules. And I think there is an improvement. 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 insomnia but also has 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, yes. So this is what we are doing in our studies, basically, Jason.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [4]

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Great. Very helpful. Looking forward to all of the readouts in the coming months.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [5]

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Coming soon.

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Operator [6]

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Our next question comes from the line of Joel Beatty of Citi.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [7]

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The first one is just on the timing for the different clinical trial results coming. Obviously, there are several readouts all in like midyear or under the first half or beginning of second half. Could you just narrow it down? Maybe tell us the order to the extent you're available of it and maybe the timing of the next results?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [8]

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So Joel, yes, I can definitely give you the order. So clearly, the first data which will come out are 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 the data on the Phase IIb with 117. And a little bit later, we will have the data on the Phase III for 101. So this is the order of data readout, basically, yes.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [9]

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Okay. Great. And then for seltorexant, obviously, that's in development with Janssen. Can you talk about, I guess, a few points to that collaboration. One being how you decide to share the data with the data -- top line data be coming from Janssen or Minerva? Another question would be who decides on kind of the design of the Phase III program? And then also, how is cost sharing for that Phase III program?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [10]

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So I will take the first part, and maybe I give over to Geoff for the financial aspects or the economic aspects. So clearly, the -- when the data will come out, when we will have the top line results and know the results, what is planned is 2 teams, the Johnson & Johnson team and the Minerva team are sitting together and we go through all the data. Because I think there is definitely a lot of expertise on the 2 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 are the best studies in the 2 indications we are following, yes. So clearly, this will be a common effort to get the maximum out of the data, which will come out, yes. So this is the way we are doing it. Now about your question about Phase III. Clearly, as you know, we have a joint steering committee and a joint development committee. And here we will debate what will be the best design moving forward, yes. This site, maybe, Geoff, you can give a little bit more granularity of how the things are organized in terms of economics?

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Geoffrey Robin Race, Minerva Neurosciences, Inc. - Executive VP, CFO, Chief Business Officer & Company Secretary [11]

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Sure. In terms of the Phase III, obviously, there is just 1 joint steering committee, but as we move into Phase III -- and that design process is well underway, as we speak. But in Phase III, Minerva has responsibility -- decision-making responsibility for the design and the execution of the Phase III in insomnia. J&J will contribute in amount of $40 million to the cost of the insomnia study. J&J has the decision-making authority for the MDD study in Phase III, and we share the costs of the MDD study on a 60-40 basis, where Minerva takes 40% of the cost of the Phase III.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [12]

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Great. And then maybe 1 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?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [13]

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So Joel, obviously -- looking for, how to say, a P value, but not only, yes, because how this study has been designed, it is really to finally confirm what is the best dose moving forward, yes. So as you know, in this trial, we had -- we have -- initially, we have 20, 40 milligram and potentially 10 milligram versus placebo. And again, 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 -- and 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 the 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 here obviously about SSRIs and SNRIs, for example. The difference is hardly reaching 2 points difference, 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 treatments or the different doses because this is also important. Keep in mind just that here we're in a quite specific situation because we are giving our molecule on top of antidepressants, and we are dealing here with a patient population, who is not responding well to existing therapies. So I mean, the reference we have here is a little bit less important, but nevertheless, to see a very nice delta between placebo and treatment is extremely important. What 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 subpopulation 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 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.

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Operator [14]

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(Operator Instructions) Our next question is from the line of Biren Amin of Jefferies

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [15]

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Maybe just to start on roluperidone. Rémy, I think you talk about high quality extensively. Can you just provide us what your experience has been so far in the Phase III trial? Have you had any high quality issues? If so, how those have been addressed?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [16]

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So I think I'm extremely reluctant 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 U.S. sites because these 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 we have currently around 60 sites all around U.S. and Europe doing a great job, yes. So data will tell us, but I'm feeling very comfortable as we speak, yes.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [17]

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

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [18]

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So it's obviously a very -- a great question, yes. So again, yes, at minimum, we need to achieve this whatever 2-point difference, yes. 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 IIa trial, we were using 2.5 and the lower dose. So I'm really expecting that we will see a more important difference here in terms of difference between placebo and treatment than 2 points. This is definitely clear. But so I think, this trial is also important to teach us about dose-dependent effects clearly between 2.5 and 5 milligram because that this -- the pharmacology of MIN-117 is quite rich or complex pharmacology. And I think by increasing the exposure, you're probably hitting a little bit more pathways in the brain and very important pathways to get a very good response. And obviously, one of -- 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, the classical inclusion criteria for depression, but we have a minimum score in terms of anxiety. So the patients need really to have a minimum score in terms of anxiety. But -- last but not least, or bottom line, what I'm hoping, is definitely to see a significant effect because the study is powered to throw a P value. I hope to see something, which is more importantly for depression than 2 points different. Two points would already be good, but 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 anxiety, but speaking about cognition, speaking about the overall level of tolerability of the drug because I think that this drug is a real positioning as a chronic treatment in depressed patients, yes. I think we have no -- it's quite interesting as the dynamic going on in the space of mood disorders. We have a lot of drugs, who are addressing very acute phases of the disease, as you know, yes. And these drugs are extremely important, but 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 IIb will tell us and we will design Phase III accordingly.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [19]

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Would you at some point evaluate what this compound comparing it to benzodiazepines, which tend to be more prescribed for antianxiety purposes in the U.S.?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [20]

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So by having worked on benzodiazepines, it seems the first one came out at Roche, yes. I think that 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 affects. So clearly, there's still a very, very, very important unmet medical need about treating generalized anxiety disorders, yes. If our data are really good in terms of anxiety -- I'm not saying that we have decided because it's -- our decision is always data driven. But if the data is extremely good in terms of anxiety, I'm not excluding the fact that we will also have some thoughts about having studies going on in anxiety, yes.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [21]

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Got it. And actually, one last question back on roluperidone. When -- if Phase III is positive, when could we expect that you would file the NDA? And are there any other small Phase I studies that you need to complete before you file the NDA and post-Phase III completion?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [22]

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Yes. So great question. So definitely, we -- as we speak, we are working intensively on the NDA preparation, yes. Because you have -- it's is 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 this side, you are right. 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 III 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 NDA, but all this work will be completely ready when we have the readout of the Phase III study. So afterwards, as you know, we will do our best efforts to get as quickly as possible to the stage of discussing with the FDA, how we file this NDA and how we move forward. To give you complete exact timing, I think it's a little bit too premature, yes.

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Operator [23]

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

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [24]

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Yes. 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 these important readouts coming soon for Minerva. Thank you so much.

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Operator [25]

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