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Edited Transcript of NERV earnings conference call or presentation 5-Aug-19 12:30pm GMT

Q2 2019 Minerva Neurosciences Inc Earnings Call

Cambridge Aug 9, 2019 (Thomson StreetEvents) -- Edited Transcript of Minerva Neurosciences Inc earnings conference call or presentation Monday, August 5, 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

* 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

* Douglas Dylan Tsao

H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare 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 Second Quarter 2019 Conference Call. (Operator Instructions) This call is being webcast live on the Investors 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.

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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 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. 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 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 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.

The first half of 2019 has been very productive for Minerva. We announced positive top line results in 2 Phase IIb trials with seltorexant, our orexin-2 antagonist currently in development for 2 indications: major depressive disorder, MDD; and insomnia. I am pleased to report that we have just obtained top line results in a further study with seltorexant. This biomarker study, designated as MDD1009, was carried out in parallel with the Phase IIb trials. The 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've also made good progress in the enrollment of patients into our 3 additional late-stage clinical trials. These include the ongoing pivotal Phase III trial with roluperidone; a further Phase II trial with seltorexant, for which recruitment has been completed; and the Phase IIb 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 IIb trial that the drug given in monotherapy showed a 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 the orexin 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-stage-specific orexin-2 antagonist in development. All other clinical-stage molecules are orexin-1 and 2 antagonists. The orexin system in the brain is extremely important and involved in the control of several key functions. These include regulation of certain metabolic functions, brain function modifications linked to abnormal stress levels and/or hyperarousal and sleep-wake rhythm dysregulation, which may lead to sleep disorders like insomnia.

As I mentioned earlier, we conducted a biomarker study known as MDD1009 study in 128 patients with moderate to severe MDD. This multi-center placebo-controlled randomized double-blind study, saw 2 doses of seltorexant, 20 and 40-milligram, were given as monotherapy and not as an add-on treatment to SSRIs and/or SNRIs as in the recent MDD2001 study. Monotherapy rather than adjunctive treatment was chosen for this study to evaluate the mechanism of action of seltorexant alone and to avoid the variable effects of antidepressant drugs. The primary objective of this study was to analyze the treatment effect of seltorexant versus placebo on symptoms of depression as measured by the Hamilton rating scale for depression 17, HDRS 17; the presence of subjective sleep disturbance; subjective sleep assessment; insomnia severity index, ISI; and ruminative response scale, RRS, as a possible indicator of hyperarousal, was used as a stratification factor in patient randomization.

I am pleased to announce that the primary endpoint analysis showed a significant positive treatment effect at week 5 for seltorexant versus placebo. The efficacy signal for the 20-milligram dose was statistically significant, p equal to 0.0049, and even more pronounced in the MDD population with sleep disorder measured as having an ISI superior to 15; and subjective sleep onset latency superior to 30 minutes during at least 3 nights over 7 days; and in MDD patients with higher rumination measured as having a rumination response scale, or RRS, superior or equal to 50. While the seltorexant 40-milligram dose did not show a statistically significant effect at week 5, MDD symptoms improved and the efficacy signal was also more pronounced in MDD patients with presence of subjective sleep disorder measured as having an ISI superior to 15.

These new findings from the MDD1009 study shows that seltorexant as monotherapy improves depressive symptoms and that this improvement is more pronounced when patients also have insomnia. Importantly, they also support the relationship between hyperarousal, clinical efficacy and the mechanism of action of seltorexant.

On May 13, 2019, we announced positive top line results from the MDD2001 trial, the Phase IIb trial of seltorexant as adjunctive therapy to antidepressant in other patients diagnosed with major depressive disorders and not adequately responding to serotonin reuptake inhibitors, SSRIs; and/or serotonin-norepinephrine reuptake inhibitors, SNRIs. The dose-finding study, the 20-milligram dose of seltorexant showed a statistically significant improvement in the Montgomery-Asberg Depression Rating Scale, MADRS score, compared to placebo at 6 weeks. Seltorexant was also observed to have even greater improvement over placebo in patients with clinically significant insomnia and a favorable tolerability profile. Additional analysis of the data are ongoing and complete details are planned for presentation during the next ACNP Annual Meeting in December of this year.

Let me now move to our recent insomnia results from study ISM2005 recently presented in a press release and discussed during a KOL call on June 24, 2019. This study, which was conducted in other and elderly patients with insomnia, explored the effects of 5-, 10- and 20-milligram of seltorexant. It was placebo-controlled and included an active arm of zolpidem, also known as Ambien. Positive top line results from this study demonstrated highly statistically significant and clinically meaningful improvement in the primary endpoint, Latency to Persistent Sleep, LPS, at night 1 after treatment with 10- and 20-milligram doses of seltorexant.

In addition to the primary endpoint, multiple secondary endpoints were improved with seltorexant versus placebo and standard of care zolpidem. Furthermore, the beneficial effects of seltorexant in elderly patients in conjunctions with favorable tolerability profile suggests its potential benefit in the large and growing population of elderly patients whose prevalence of sleep disorders, including insomnia, is higher than in younger patients.

To summarize, the data announced this past quarter demonstrate that seltorexant is able to improve depressive systems in MDD patients not responding adequately to first-line therapies as well as in MDD patients treated with monotherapy. The observed improvements in these patients are more pronounced when associated with insomnia. In addition, improvements in insomnia were observed in patients without associated neuropsychiatric comorbidities, and these improvements was superior to those observed after treatment with zolpidem and present in others and in the elderly. Importantly, these therapeutic effects were observed without major side effects as the safety and tolerability profile of seltorexant is comparable to that of placebo.

Taken together, the findings from the 3 trials conducted today confirms the unique ability of seltorexant to address unmet medical needs in both mood and insomnia disorders.

Let me now provide an update on roluperidone, our most advanced program in a pivotal Phase III trial. We are continuing to recruit patients in this trial with the diagnosis of schizophrenia who present with negative symptoms. This trial will enroll approximately 500 patients at approximately 60 clinical sites in the U.S. and Europe. The design of the Phase III trial is fundamentally consistent with that of our successful Phase IIb trial. We are seeking to replicate the statistically significant improvements in negative symptoms observed in the Phase IIb as measured by the PANSS scale, which constitutes our primarily end point.

Furthermore, we are assessing 2 secondary endpoints which are the PSP, Personal and Social Performance scale, total scores and the CGI severity scale. The reason for selecting these 2 secondary endpoints is to demonstrate that an improvement in negative symptoms translates into functional improvements in patients treated with roluperidone. With respect to the effects observed on the PSP scale in our Phase IIb study, I am pleased to report that the scientific publication has been accepted recently in the Schizophrenia Research Journal about the scale, which is one of the best ways to show that an improvement in negative symptoms translates into a functional improvement in patients treated with roluperidone.

Concerning the Phase III study, our main focus is on the close monitoring of sites in Europe and in the U.S. to ensure adherence to key parameters of this plan. This includes careful patient selection and objective assessment of patient symptoms during the treatment phase. We expect to read out data from the 12-week double-blind treatment of the Phase III trial in the fourth quarter of 2019.

In parallel, we're also moving forward with considerable preparatory work for the filing of a new drug application, NDA, for roluperidone, pending a positive Phase III study. We recently had completed a clinical pharmacology trial focused on drug-drug interaction, DDI studies, which comprise a standard part of the NDA. Without going into many details, this include interactions with molecules separately inhabiting 2 subtypes of the cytochrome P450, CYP2D6 and CYP3A4. The data from this study are currently being analyzed and preliminary data show minimal interaction. Our commercial team also continue to work on the positioning and launch strategy for roluperidone.

Moving on to our last clinical-stage product. We are continuing to recruit patients in our Phase IIb trial with MIN-117. Patients recruited in this trial have a diagnosis of MDD associated with anxiety. Based on our previous clinical findings, we believe that these patients may benefit particularly from treatment with MIN-117. Approximately 324 patients are expected to be enrolled in this trial in about 40 sites in the U.S. and Europe. The study design includes a screening phase, a 6-week double-blind treatment phase and a 2-week post-study follow-up period. Top line results are expected in the fourth quarter of 2019.

In summary, the first half of 2019 has been tremendously exciting with really important clinical readouts for seltorexant that demonstrate the potential of this molecule to treat multiple groups of patients in the therapeutic areas of MDD and insomnia. We look forward to the second half of the year, which will provide important results for our 2 late-stage clinical molecules, roluperidone and MIN-117.

I will now turn it over to Geoff who will describe our financials in greater detail.

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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 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 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 III clinical trial of roluperidone and the Phase IIb clinical trial of MIN-117.

For the 6 months ended June 30, 2019, R&D expenses were $19.9 million compared to $17.5 million for the 6 months ended June 30, 2018, an increase of $2.4 million. This increase primarily reflects higher development expenses for the Phase III clinical trial of roluperidone and the Phase IIb 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 6 months ended June 30, 2019, G&A expenses were $9.3 million 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 noncash stock-based compensation expenses and salary costs from increased staffing to support our precommercial 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 6 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 6 months of 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 Joel Beatty with Citi.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [2]

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

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

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Joel, Rémy speaking. So I think, as I always explained and I think I explained this during the last earnings call we had, I mean the last study we are reading out very soon is a study which is a comparison over a period of 6 months between our molecule and quetiapine which is a standard of care to treat patients who are not responding adequately to SSRIs or 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 the basic plan of the Phase III or the registrational 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 where we are going, yes.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [4]

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Okay. Got it. A question about the Phase III roluperidone program and the mix of patients between Europe and the U.S. I guess, 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 wiggle room there? And 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?

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

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So as you know, I mean what we have discussed with the FDA at the end of Phase II 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, things are quite in line with these numbers. But I mean it's obviously not 30% exactly. But I mean it's very, 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 IIb and the Phase III, because in the Phase IIb, 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 -- and I was always concerned about the way these patients are recruited 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., the sites are doing a great job in assessing the symptoms of the patients. So again, I mean we have more screen failures, so less patients were included in the 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.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [6]

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

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

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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 FDA at the end of Phase II meeting. So I think we are really ready, based on positive data of the Phase III, to really start to discuss with the FDA, yes?

So really, I think what we have announced before will be respected because we are really ready with all the different modules of the NDA. Obviously, we need to have the results of the Phase III, the double-blind phase. And afterwards as you know, we are doing -- or we are proposing to the patient an extension of 9 months in order to have 12 months safety data. This will come in on a rolling base, but definitely, we are completely on time for the NDA filing.

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Operator [8]

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And our next question comes with Douglas Tsao with H.C. Wainwright.

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Douglas Dylan Tsao, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [9]

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Just -- Rémy, just going back to the MDD1009 study for seltorexant. Just as a 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 sort of pivotal trials? We obviously already knew about the effect with an antidepressant as well as the effect on sleep. And so I'm just curious from your perspective, what was the big key takeaway?

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

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So great, great question, obviously. And I think the good problem we have here is that we have no -- another option here, yes? Because this is really a very nice demonstration that -- I mean this 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, yes? 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 able to detect arousals, which are able to detect stress, and we will learn more about the mechanism of action.

But basically, what 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 am really insisting on this because if you compare this to dual antagonists, this is not at all the same profile. And interestingly enough, I mean in our case, we cannot discriminate in terms of side effects from placebo, so we had a very, very good safety profile, yes? So I think it is just confirming what we were thinking, how the drug is working. And it gives us even more confidence that what we are doing, moving forward in Phase III, will be successful, yes? But it does not change anything in terms of thinking in terms of development plan.

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Douglas Dylan Tsao, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [11]

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

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

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No -- completely. You are completely right.

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Douglas Dylan Tsao, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [13]

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And does that give 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 as a -- as an adjunctive therapy?

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

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So as of today, I mean we have not completely finalized our Phase III 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 in the Phase III, which will be probably add-on to existing therapies. But again, don't take it as completely granted because, I mean, discussions are still going on. But again, 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.

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Operator [15]

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(Operator Instructions) We have a question from Jason Butler with JMP Securities.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [16]

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Just another one on the new data from the 1009 study. Can you just, Rémy, maybe speak to how these new results impact your views on advancing the 40-milligram dose as well as the 20-milligram dose in sort of the next stages of development?

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

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Jason, I was expecting this question. Great question, yes. So clearly, I mean, 20 milligram is crystal clear, yes, as you have seen. We have exactly the same results in monotherapy as the results we have seen in add-on, yes. So 20-milligram is and will remain the cornerstone dose.

We are still working on better understanding what is going on with 40-milligram. A lot of work has been -- is currently ongoing. We're trying to understand how the free fraction of the drug is impacting the results. So we're already working very hard on this 40-milligram data. In other words, I mean to be more precise, we are really 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 III will be with 1 dose or with 2 doses, including 40 milligrams. So stay a little bit with us, and I assume during the next quarter, I can give you complete clarity of where we are going.

But again, 20-milligram is definitely confirmed to be the cornerstone dose. And as you have seen also for insomnia, 20-milligram is an important dose. This said, you have also seen that with 10-milligram, we have a very, very nice effect on insomnia. So obviously with insomnia, we also contemplating lower doses than 20 milligrams. But again, stay with us for a few more weeks and I will give you the complete clarity on where we are going.

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Operator [18]

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Our next question comes from Biren Amin with Jefferies.

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

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Rémy, on roluperidone Phase III trial, can you just talk about the readthroughs from the recent ACADIA study that have failed?

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

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Yes. So thank you for the question. So 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 obviously what we are doing, yes? 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 they are going with a minimum score of negative symptoms. But again, it will be add-on to antipsychotics.

So I mean long story short, I think we cannot, how to say, draw any conclusion from this study concerning our trial, yes, so -- our drug. Obviously, there is something in common, which is the 5-HT2A antagonism or inverse agonism, which by the way, is giving 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 a 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 a 5-HT2A antagonism and the sigma2 antagonism. So again, interesting, important data, but we cannot really conclude based -- or to expand to our data, definitely not.

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

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And then maybe just some follow-up questions. On seltorexant, the 1009 trial, can you just talk about if you saw a treatment effect difference with the 20-milligram dose before week 5? So I guess the question is how quick was the onset of effect?

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

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So it is definitely following the same time course as what we have seen in the add-on study, yes? So definitely, you start to see a differentiation between placebo and treatment after 2 weeks because this was the first time we measured, really. And the things are building up over time. So definitely, exactly the same time course as what we have seen in the add-on study. So this is what you can have as a take-home message from this data, which by the way, is again, very, very, very reassuring because -- and I'm always intrigued, I mean, one study shows something, the other one shows something different. Here in this case, I mean, the time course of the effect on mood is exactly the same.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [23]

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And then on the 2002 trial that's ongoing where you're expecting update on Q3, are you evaluating both the 20- and the 40-milligram doses?

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

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In fact, it's a great question. It's a flexible-dose study. So basically, we give the possibility. Because as you know, quetiapine is also -- when you prescribe quetiapine for patients who are not responding well to existing antidepressants, you give the flexibility to the prescriber to have different doses, yes, 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 PIs or to the sites to have an opportunity to give 20 or 40 milligrams. So definitely, they have the possibility to decide about the dose. So this is a flexible-dose study, yes? So clearly, we have 20- and 40-milligram. We will obviously analyze also the study or the patients who have received 20 compared to 40-milligram in order to continue to check what is going on between the 2 doses. But definitely, this is a flexible-dose study.

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Operator [25]

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And I'm showing no further questions at the time. I'd like to turn the call back to Mr. Rémy Luthringer for any further remarks.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [26]

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No. So really, thank you for all these questions and thank you for everybody attending this call. And I am really looking forward to updating you on our progress in the near future because second half of this year will be also a very important year -- second half of the year like it has been since the beginning of the year. So we'll be looking forward to speak with you again soon.

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Operator [27]

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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.