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Edited Transcript of NERV earnings conference call or presentation 4-Nov-19 1:30pm GMT

Q3 2019 Minerva Neurosciences Inc Earnings Call

Cambridge Nov 6, 2019 (Thomson StreetEvents) -- Edited Transcript of Minerva Neurosciences Inc earnings conference call or presentation Monday, November 4, 2019 at 1:30:00pm 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

* 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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* Douglas Dylan Tsao

H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst

* Douglas Royal Buchanan

JMP Securities LLC, Research Division - Associate

* Jessica Lee Schmerler

Chardan Capital Markets, LLC, Research Division - Senior Research Associate

* Myles Robert Minter

William Blair & Company L.L.C., Research Division - Analyst

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Presentation

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Operator [1]

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Welcome to the Minerva Neurosciences Third Quarter 2019 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 third 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 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. 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 September 30, 2019, filed with the SEC on November 4, 2019. Any forward-looking statements made on this call speak only as of today's date, Monday, November 4, 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. As we near the end of this year, I would like to review the progress we have made during 2019 in each of our clinical stage programs.

First, we have completed and read out top line results from 4 trials with seltorexant in major depressive disorder, MDD and insomnia. Second, we have concluded enrollment in the Phase IIb trial with MIN-117 in MDD, and we expect to have top line results in the fourth quarter of 2019. Finally, we have advanced patient enrollment in our pivotal Phase III trial with our lead product, roluperidone, and we have resumed the pacing of patient recruitment following the temporary delay we discussed in October.

Beginning with the Phase III trial with roluperidone, enrollment rates have returned to expected levels. As we stated last month, we remain on track to complete enrollment of 501 patients at approximately year-end. In assessing the impact of the recent pause in recruitment that we discussed in October, we considered expanding the number of trial sites to compensate for slower enrollment but we choose to not jeopardize the integrity of the study and elected to maintain quality over speed. This randomized double-blind, pilot group placebo-controlled 12-week trial is designed to evaluate the efficacy and safety of 32 milligrams and 64 milligrams of roluperidone as monotherapy in adult patients suffering from negative symptoms of schizophrenia. The primary endpoint of this trial is a change from baseline in negative symptoms using the Positive and Negative Syndrome Scale, PANSS, a modest Negative Symptoms Factor Score, NSFS, over the 12-week double-blind treatment period. After 12 weeks, patients enter into a 40-week open-label extension period, during which those on active drug during the double-blind phase continue to receive their original dose, while patients on placebo are randomized to receive either 32-milligram or 64-milligram of active drug if they elect to enter the extension period.

Key secondary endpoints includes the Personal and Social Performance scale, PSP, and Clinical Global Impression of Severity, CGI-S. This trial is addressing a significant unmet medical need, negative symptoms in schizophrenia, for which no treatments are approved. Our overriding objective is to maintain the quality of patient screening and selection to ensure that all enrolled patients strictly meet the study's predefined entry criteria.

Other activities related to the roluperidone program, specifically preparation for the filing of a New Drug Application, remain on track. For example, during the past quarter, we entered into a commercial supply agreement with Catalent, under which we will transition from pilot to commercial scale manufacturing and packaging. We remain confident in the potential of this trial to generate the product profile that reflects an exciting new therapeutic approach to treating negative symptoms in schizophrenia.

Moving to MIN-117. We have completed enrollment in a Phase IIb trial of a total of 360 adult patients diagnosed with major depressive disorder without psychotic features and with at least moderate levels of anxiety. We believe that patients with this disease characteristics may benefit particularly from treatment with MIN-117 based on the pharmacological profile of the molecule shown in earlier clinical testing. The study design includes a screening phase, a 6-week double-blind treatment phase and a 2-week post-study follow-up period. The primary objective of this trial is to evaluate the efficacy of 2 doses of MIN-117, 5-milligram and 2.5 milligram, compared with placebo in reducing the symptoms of depressed mood as measured by the change from baseline in the Montgomery-Asberg Depression Rating Scale, MADRS, total score over a 6-week treatment period.

Secondary objectives include: first, assessment of the change from baseline in symptoms of anxiety using the Hamilton Anxiety Scale, HAM-A; second, the change in severity of illness using the Clinical Global Impression of Severity Scale, CGI-S, and Clinical Global Impression of Improvement scale, CGI-I; and third, safety over 6 weeks of treatment. In addition to these measurements, we also plan to assess cognition, sexual function, sleep and onset of action in mood improvement. We expect to have top line results from this trial in the fourth quarter of 2019.

Our last clinical stage product, seltorexant, is under co-development with Janssen Pharmaceutica. During 2019, we completed and announced top line results from 3 Phase IIb trials and 1 Phase Ib trial with seltorexant, also known as MIN-202. Three of these trials were in MDD and one was in insomnia disorder.

As we have published these results in details recently, I would like to summarize key cumulative conclusions following completion of these trials. First, seltorexant shows meaningful and consistent improvements in mood and sleep symptoms. In depressed patients, seltorexant shows improvement in mood as monotherapy and as add-on therapy to SSRIs or SNRIs, and its effect on mood is stronger in patients with insomnia. Among the doses tested, the 20-milligram dose of seltorexant shows the most robust and consistent effect on mood. In most other -- and every subjects, seltorexant improves both sleep induction and sleep maintenance compared to zolpidem. The safety and tolerability profile of seltorexant cannot be discriminated from placebo. We believe the data from this study has defined a new mechanism of action, selective orexin-2 receptor antagonism that shows benefit over current treatments for both insomnia and MDD and with an encouraging safety profile. We're currently discussing the next steps in the program with Janssen.

The trials I have described defines the focus of our activities during the year. We have moved roluperidone, seltorexant and MIN-117 forward significantly in clinical testing. We look forward to the next steps in the development and regulatory pathways for this exciting product candidates, which we believe are highly differentiated from currently approved products in the target indications.

I would now like to turn the call over to Geoff for our financials.

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

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Thank you, Rémy. Earlier this morning, we issued a press release summarizing our operating results for the third quarter ended September 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 September 30, 2019 were approximately $60 million. We believe that the company's 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 mid-2021.

Research and development expenses for the 3 and 9 months ended September 30, 2019, were $9.7 million and $29.6 million, respectively, compared to $8.4 million and $25.9 million for the same periods in 2018.

General and administrative expenses for the 3 and 9 months ended September 30, 2019, were $4.6 million and $13.9 million, respectively, compared to $4.1 million and $12.2 million for the same periods in 2018. The increase in G&A expenses during the 3-month period was primarily due to higher professional fees to support pre-commercial activities. And in the 9-month period, the increase also included noncash stock-based compensation expenses and salary costs.

The company reported a net loss for the 3 and 9 months ended September 30, 2019, of $14 million and $42.3 million, respectively, or $0.36 and $1.08 per share, respectively, compared to $12 million and $37 million, respectively, or $0.31 and $0.95 per share, respectively, for the same period in 2018.

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

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Biren Amin from Jefferies.

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Unidentified Analyst, [2]

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This is [Jean] on for Biren. Rémy, correct me if I'm mistaken, but in your prepared remarks, you stated that you'll be expanding the number of sites to counter the recruitment delay for the roluperidone Phase III. Could you elaborate on this decision and on the quality of these sites and perhaps which countries they are coming from? And I have some follow-up questions.

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

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I think maybe my English is not good enough. No, no. We -- it's exactly the opposite. So what I was saying is that we obviously are always contemplating to add additional sites. But clearly, as you know, I'm not a big fan of adding sites for obvious reasons of variability, and to do this so late in the process of recruitment would not be wise. So definitely -- sorry, again, if my English was not good enough. But I mean, definitely, we have not added any sites.

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Unidentified Analyst, [4]

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Okay. And in just your 10-Q that you had published this morning, it looks as though you've also recently completed some drug-drug interaction studies for roluperidone and have recently analyzed some of the preliminary data that showed minimal interaction. Could you elaborate on those studies and perhaps what those results specifically showed?

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

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Sure. Sure. And I think I already addressed this the last time, but I mean -- so what we have done, I mean, and this is obviously an agreement of what we have discussed with the FDA in the Phase II meeting, the biggest interaction studies we had to perform was interaction with 2 cytochromes P100, 450 were IID6 and 3A4. So we have completed these 2 studies, I mean, interactions with IID6 and 3A4. And the effect on the exposure levels of MIN-101, [aceto] MIN-101 is the active part of the molecule and on the different metabolites is really marginal. And that's the reason why, I mean, these are extremely very good results because they show that, indeed -- I mean, obviously, the drug is a drug for monotherapy, but I mean, it can also be given in add-on because the PDI aspect is really minimal.

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Unidentified Analyst, [6]

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Got it. And also just regarding MIN-117, it looks as though you've filed new patent application related to neuropathic pain. Could you perhaps provide some color on the mechanism of action of 117 in pain? And is this an indication you plan to pursue?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [7]

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Yes. I mean, so I think the results -- so again, I mean, these results are all preclinical models. But as you know, in this area, the preclinical models are extremely predictive of what you will see in clinic. So I mean, we have really, really exciting results there and that's the reason why we filed it.

So how we came to this idea -- to this research was, I mean, as we know SSRIs for example, like duloxetine, are also having an effect on some pain models and have given an indication in clinics. So we really wanted to deeply go into this understanding. And I think our molecule has much better results than what you can see currently available.

And so now concerning the mechanism of action, it is obviously difficult to come to a final conclusion. We are still working on this. As you know, MIN-117 is an extremely rich pharmacology combining serotoninergic pathways and the dopaminergic pathways. You can always guess or based on literatures that is mostly serotoninergic pathway, which is implicated in the control of pain. But I think to come up with a firm conclusion that today it's not possible. But clearly, I mean, what it shows is that, I mean, this pharmacology -- this complex pharmacology, this rich pharmacology has an incredible effect on pain models.

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Unidentified Analyst, [8]

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Great. And just maybe one more quick one from me. It looks like you've also had some results for MIN-301 in a primate model of Parkinson's. When do you intend to file the IND for 301?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [9]

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So I mean, we have really started the preclinical packages. We had a little bit of struggles with the bioanalytic method. And now this is really solved because, as you know I mean here, we are working with the external domain of Neuregulin-1b1, and you need to have a very sophisticated method in order to really discriminate between the endogenous secretion of neuregulin and MIN-301. We have now solved this problem and now we can go full speed with the preclinical package. So we are really, I think, on track to be ready for an IND filing during the course of next year.

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Operator [10]

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Our next question is from Joel Beatty from Citi.

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Unidentified Analyst, [11]

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This is [Sean] calling in for Joel. Two for me this morning. Can you remind us what time lines are around the next steps for seltorexant and any developmental decisions with Janssen?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [12]

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So as I mentioned in my presentation or in my script is that we are really, I mean, working with our colleagues from Janssen to really come up with the best plan moving forward. We're already advancing very well. We have obviously a lot of debates because, as I already explained, I think in the past is that this molecule gives so many opportunities due to the fact that the MIN, it is definitely a great drug for insomnia. I think it is a drug which is really doing something on hyperarousals which is obviously something which is important in insomnia, and it is also translating in some effects on mood. And as I mentioned, these effects are good, are more pronounced, if I mean, you have complaints of insomnia in depressed patients.

Now the next step is that we are very soon going to have an end of Phase II meeting with the FDA. And obviously, also, we are seeking for scientific advice in Europe. And based on this feedbacks which would be happening very shortly, we will be able to finalize a plan and move forward. So again, stay with us a little bit and we will update you when we have all these feedbacks, and when we have the possibility to finalize our complete development plan.

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Unidentified Analyst, [13]

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Great. And then as a brief follow-up. For roluperidone, do you anticipate you'll need to wait for the 12-month safety data prior to filing? Or will you be able to file ahead of that?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [14]

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This is obviously a great question. So technically, the primary endpoint is on the 12 weeks double-blind phase. So clearly, this will be the moment where we start to file. And I think we can really give the 12-months safety data because, as you know, the 12 months is really -- to tick the box, about 100 patients with 12 months of safety data. I think this can be given or can be added to the NDA in a rolling way. And I think we do -- we do not have to wait. I mean, we will really start to interact with the FDA when we have the blind phase results.

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Operator [15]

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Our next question is from Jason Butler from JMP Securities.

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Douglas Royal Buchanan, JMP Securities LLC, Research Division - Associate [16]

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This is Roy on for Jason. I just had a follow-up on the end of Phase II for seltorexant. Has that been scheduled with the FDA?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [17]

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So the submissions have been done, and we are waiting for data.

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Douglas Royal Buchanan, JMP Securities LLC, Research Division - Associate [18]

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Okay. Great. And then can you remind us for the roluperidone, the data breach on the Phase III. Did you discuss that with the FDA as well? And did they recommend any changes to the conduct of the trial or have any other comments on your plans that you can share?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [19]

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No. No. Definitely, I mean, we had a full agreement with the FDA when we had the end of Phase II meeting. And we really deeply analyzed our Phase IIb data, which, as you know, have been analyzed like pivotal or registrational study. So clearly, I mean, it was a very smooth discussion and nothing has changed since we have submitted the protocols, especially protocol to the FDA.

We are, obviously, exchanging with FDA on a regular base because this is how it is when you're going into late-stage development. We have obviously expanded in terms of CMC. We also had a meeting concerning CMC. So we have a lot of exchanges. But, I mean, in terms of study design, study protocol, primary endpoints, nothing has changed since we had the end of Phase II meeting.

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Operator [20]

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Our next question is from Jessica Schmerler from Chardan.

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Jessica Lee Schmerler, Chardan Capital Markets, LLC, Research Division - Senior Research Associate [21]

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Just one quick one from me. In terms of the cash runway through mid-2021, is that making any assumptions about the outcome of the decision with Janssen? Or is there any possibility that, that may change after that decision is announced?

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

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Yes. Jessica, the cash burn rate over the last couple of years has been around about $11 million a quarter. But we expect that to drop significantly over the next year as we run out the extension period on roluperidone, and we prepare for the next steps with 117 and seltorexant. And obviously, as we get clarity on those plans, we'll make adjustments to our cash predictions as necessary.

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Operator [23]

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Our next question is from Myles Minter from William Blair.

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Myles Robert Minter, William Blair & Company L.L.C., Research Division - Analyst [24]

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I'm just wondering about the proportion of U.S. to EU patients in the roluperidone program, sorry to harp on about this. But particularly in the open-label extension portion of that program, does the FDA care about the proportion of patients from U.S. versus EU in that for a potential safety database readout?

And also, how's the update on enrollment into that portion of the arm? Are you seeing a dropout rate that would be comparable to the double-blind phase of that trial? I've got a follow-up after that.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [25]

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Obviously, this is a great question. And I think as I explained already in the past, I mean, we really have done this in a very interactive way with the FDA. Yes, I mean, so clearly, I mean, what has been agreed is that, I mean, we will do our best efforts in order to come as close as possible to 30% of the patients coming from the U.S. But again, let me be crystal clear, this was not mandatory. This was the best efforts. So what I mean, the FDA, and we really discussed this, I think, extremely open-minded and clearly, the objective here is that, I mean, the overall study, combining patients from Europe and from the U.S., this is the primary endpoints of the complete study or the complete 501 patients. And what the FDA would like to see, and we discussed this with our advisers very carefully, and some of the advisers are heavily involved in the (inaudible) divisions before, so you can guess who it is, are really very clear. I mean, they want to see if, I mean, the U.S. patients are going into the same direction in terms of improvement of the negative score of the PANSS scale as accorded to the Marder score. But I mean, this is the only objective here. We have to -- also to the only box to tick, basically. So again, 30% is the best effort.

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Myles Robert Minter, William Blair & Company L.L.C., Research Division - Analyst [26]

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Okay. So just to clarify, there's no difference in the expectations in the efficacy portion of the trial and the open-label extension safety portion of the trial as to how many patients in the U.S. and the EU they would require?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [27]

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I think the overall safety is important. And as of today, what I can tell you is that this is just a good practice. It's even recommended in the guidelines, what we are doing. We are monitoring completely blinded, putting all these patients in the same part because, obviously, all is blinded. So truth -- the truth of this, of our molecule versus placebo, and we are really checking how, I mean, the scale is behaving here in terms of efficacy. And what I can tell you is when you're going blind, you don't see any difference between the different patients from whatever region of this planet they are coming, yes, Europe or the U.S.

In terms of safety, it is exactly the same. I mean, there is nothing which is popping up, which is different between -- again, all this is blinded, obviously, but I mean, popping up between the U.S. patients and the European patients. So I think as of today, again, all being completely blinded, but we thought very carefully. It is -- actually it is clearly impossible to see any difference between U.S. patients and European patients. And I think it is really a very important point here. Yes, indeed, I mean, in terms of screening, we have much more screen failures in the U.S., which I think is something which is extremely good in my view because, I mean, it shows that, I mean, we are really picking up the right patients. And as you know, in the U.S., I mean recruitment is done often by advertisement. So it's normal that you have more screen failures because, I mean, you have a little bit more noise coming in. But, I mean, I think our filter is really working well. That's the reason why we have more screen failure. But once the patients are in the study, and as I explained before, in terms of safety, in terms of efficacy, we cannot see any difference between U.S. and European patients.

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Myles Robert Minter, William Blair & Company L.L.C., Research Division - Analyst [28]

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Got it. That's helpful. And then just on MIN-117, what are the powering assumptions on the MADRS scale for that trial? Is it a 2.5 point difference over placebo? I think I've heard that as the sort of the clinically meaningful threshold there.

And a theoretical scenario, do you have enough U.S. patients in that trial that if the data is good, that you could potentially apply for breakthrough designation for that drug, as we've seen with some peer companies in the space using their early Phase II trials as 1 pivotal and a single Phase III for approval in that later stage?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [29]

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So these are 2 great questions. Yes, I mean, so in terms of powering, I mean, yes indeed, I mean, you go always with the 2.5 points. But obviously, based on what we have seen in this very small Phase IIa study, I mean, we can really hope to see a greater delta, yes, between the treatment and placebo. Keep in mind that, I mean, in this Phase IIb trial, we are using 2.5 milligram and 5 milligram, whereas in the small Phase IIa study, we used 0.5 and 2.5 milligrams. So really here, I mean, depending on the pharmacology and I think by increasing the exposure, hitting more pathways with our molecule, we should really see a really good effect with 2.5 where we have already a very good hint that, I mean, it's definitely more than 2.5 points. And with 5, hopefully, we will see more.

Now concerning your second point about the number of U.S. patients. Interestingly enough, in this study, we recruited extremely well in the U.S. So yes, I think if the data are extremely good, we can always contemplate all different options and obviously go to discussions with the FDA. So we have, I think, the pool within in order to contemplate all the different options herein.

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Myles Robert Minter, William Blair & Company L.L.C., Research Division - Analyst [30]

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Look forward to the Janssen update when it comes out.

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Operator [31]

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Our next question is from Douglas Tsao from H.C. Wainwright.

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Douglas Dylan Tsao, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [32]

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Just -- maybe Rémy, just in terms of MIN-117, just curious if things play out as we hope and expect, the interest in advancing that into Phase III by yourself versus potentially seeking a partner like you did with seltorexant.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [33]

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Yes. So again, a great question. So again, I think you said it correctly. I mean, let us see the results. Let us see where we land with these results. And I think based on these results, we will contemplate the different options. But give us a little time and let us wait for the results, please, Douglas?

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Douglas Dylan Tsao, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [34]

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Okay, great. And so meaning that there are scenarios where both of those options would make the most sense.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [35]

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When you're running a company like ours with core molecules where you have different types of options, different indications. I mean, take roluperidone. Roluperidone, as you know, negative symptoms. If we have a positive readout here, we know that negative symptoms are in 19 different diseases in the DSM-5. So I mean, it becomes obviously a very, very huge portfolio with a lot of indications. So you have to be open and listen to the different options. As of today, I mean, let us first have the readout of the data, and we will update you on what's next here.

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Douglas Dylan Tsao, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [36]

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Okay. And then just in terms of roluperidone, in terms of the breakdown between U.S. and Europe enrollment, have you seen any change in terms of dropouts between the 2 regions? Or has that been largely the same?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [37]

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Can you repeat the end? I did not hear the end.

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Douglas Dylan Tsao, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [38]

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Just in terms of dropouts. Any difference between the dropout rates between the 2 regions for roluperidone?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [39]

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No. The answer is -- the short answer is, no. We have not seen any difference. It's really dependent site by site. I mean, I think here, I mean, when you have selected the right site, I think again, as I've have explained, I mean, the screening is related to the fact of the way the patients are recruited. But when the patients are in the study, definitely, there is no difference at all. So you have to follow each site. You have to really be close. I mean, obviously, through our CRO with each site, I mean, if you have the feeling that something is not completely perfect, I have to say that we are not to intervene a lot or to go back to the site and to reexplain what we are trying to achieve here. So clearly, I mean a long story short, I mean, we don't see a difference between U.S. sites and the European sites in terms of dropout.

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Operator [40]

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At this time, I'm showing no further questions. I would like to turn the call back over to Rémy Luthringer for closing remarks.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [41]

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Yes. So thank you all for these great questions and those interest in our molecules. So it is true that we have very exciting weeks and few months ahead of us. And I'm really, really looking forward to update you on all the results coming out after a very successful read out of the first molecule. So seltorexant, I mean, the 2 other molecules we read out very soon and really looking forward to update you.

Thank you again for being at this call. Thank you, and bye-bye.

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Operator [42]

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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.