William Boni - VP, IR & Corporate Communications Remy Luthringer - President and CEO Geoff Race - EVP, CFO and Chief Business Officer

Jason Butler - JMP Securities

Welcome to the Minerva Neurosciences Year-End 2016 conference call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session following today's prepared remarks. This call is being webcast live on the Investors section of Minerva’s website at ir.minervaneurosciences.com. As a reminder, today's call is being recorded. I would now like to turn the call over to William Boni, Vice President, Investor Relations and Corporate Communications at Minerva. Please proceed.

Good morning. A press release with the company's fourth quarter and year-end 2016 financial results became available at 7:30 AM Eastern Time today and can be found on the Investors section of our website. Our annual report on Form 10-Q was also filed electronically with the SEC this morning and can be found on the SEC's Internet website at www.sec.gov. Joining me on the call today for Minerva are Dr. Remy Luthringer, President and Chief Executive Officer, 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, including, without limitation, whether and when any of our therapeutic products will advance further in the clinical trials process; whether, when, and to what extent results from such trials will be available; the timing and outcome of future interactions with the US and foreign regulatory bodies; and whether and when, if at all, such products will receive final approval from the US Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products will be successfully marketed, if approved; whether any of our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management's ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; the sufficiency of our current cash position to fund our operations; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption Risk Factors in our filings with the Securities and Exchange Commission, including our quarterly report on Form 10-K for the quarter ended December 31, 2016, filed with the Securities and Exchange Commission on March 13, 2017. Any forward-looking statements made on this call speak only as of today's date, Monday, March 13, 2017, and the company disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after today's call, except as required by law. I would now like to turn the call over to Remy Luthringer.

Thank you, Bill, and good morning, everyone. Thank you for joining us today. 2016 was a pivotal year for Minerva as a public company. During the year, we reported five data read-outs for our three clinical stage product candidates. This include MIN-101 for negative symptoms in patients suffering from schizophrenia, MIN-202 for insomnia disorder and for the adjunctive treatment of major depressive disorder MDD and MIN-117 for MDD. This data laid a solid foundation for the future development of our compounds and thus reflect significant progress along the respective clinical development pathways for these products. More importantly they inform our decisions regarding the nature of advanced stage clinical testing, we plan to initiate in 2017. Today, I would like to take both a look-back on the last year’s achievements and to look forward for this year’s objectives. In the second quarter of 2016, we announced that our Phase 2b trial evaluating MIN-101 in monotherapy with daily doses of 32 milligram and 64 milligram compared to placebo achieved its primary endpoint, which was improvement in negative symptoms. Of note, improvements were also observe [ph] the numerous pre-defined secondary and exploratory endpoints including total PANSS score and cognition. The observed improvements shared the same time course beginning to differentiate from placebo as early as two weeks after treatment initiation and continuing over the 12 week double-blind period. Very importantly, treatment with MIN-101 helped keep positive symptoms tabled over the complete treatment period without observed side effects such as sedation or motor effects. To the best of my knowledge, MIN-101 is a first treatment for schizophrenia with a specific effect on negative symptoms, such raising the possibility that it might be the first treatment to address the significant unmet medical need in patients suffering from this disease. Later in the year, we announced…

Thank you, Remy. Earlier this morning we issued a press release summarizing our operating results for the fourth quarter and year-ended December 31, 2016. A more detailed discussion of our results may be found in our annual report on Form 10-K filed with the SEC earlier today. Net loss was $9.4 million for the fourth quarter of 2016 or a loss per share of $0.27 basic and diluted, compared to a net loss of $8.4 million for the fourth quarter of 2015, or a loss per share of $0.34 basic and diluted. Net loss was $31 million for the year ended December 31, 2016 or a loss per share of $0.99 basic and diluted, compared to a net loss of $27.1 million or a loss per share of $1.16 basic and diluted for the year ended December 31, 2015. Research and development expenses were $6.5 million in the fourth quarter of 2016, compared to $6.3 million in the fourth quarter of 2015. R&D expenses were at $20.4 million for the year ended December 31, 2016 compared to $18.5 million for the year ended December 31, 2015. This increase in R&D expenses primarily reflects higher development costs under the MIN-202 program for Phase 2 clinical trial preparation and an increase in non-cash stock based compensation expenses. This increase was partially offset by decreased expenses due to the completion of our Phase 2b clinical trial of MIN-101. General and administrative expenses were at $2.7 million in the fourth quarter of 2016, compared to $1.9 million in the fourth quarter of 2015. G&A expenses were $9.8 million for the year ended December 31, 2016 compared to $7.6 million for the year ended December 31, 2015. The increase in general and administrative expenses was primarily due to an increase in non-cash stock based compensation…

[Operator Instructions] our first question is from Jason Butler with JMP Securities. You may begin.

Just a couple of MIN-202, can you give us any color on what - other than finalizing trial design whether there are any gaining items in the non-clinical studies ongoing right now that needs to be completed before starting the next trials. And then can you give us any color on the likely or a potential trial designs or patient populations that you intend to study in the next trials. Thanks.

Thank you Jason for this question, Remy speaking. As the work which is currently ongoing is really standard work in order to speed up the process and to have altogether in order to run the two clinical trials. So nothing in particular, just I have to say doing the studies in order to be ready to move. In terms of the two studies we currently plan to carry out in patients so far with insomnia. So primary insomnia indication, we are really planning it for study where we confirm what we have seen in the Phase IIA in terms of efficacy, also in terms of very improved day time functioning in these patients. So we will have a lot of pharmacodynamics measurements in addition to the efficacy measurements based on poly-somnography and some clinical scales. And we will also have some comparison with the standard of care in order to really position our molecule at best. In depression, here again it will be done as it has been done in the phase 1b, so it is really a study which is very similar in terms of study design and in terms of adding it to standard of care as well. So this is what I can tell you today about the two studies.

[Operator Instructions] our next question comes from Byron (inaudible) with Jefferies. You may begin.

On MIN-101 Fda’s meeting coming up, would you hope to agree with FDA on what are one of the outstanding issues currently that you hope to iron out by FDA meeting?

I’m afraid that i did not completely understand the end of your sentence, can you repeat please.

Are you hoping to gain agreement with the agency on primary endpoint for the trial or is there something that you feel that FDA will likely agree with your study design and what other outstanding items are you hoping to discuss with FDA at the meeting?

So definitely this meeting is to confirm the primary endpoint and also the study design of our study. So clearly this is a primary objective. And yes indeed the agency will decide we are already proposing a study design which is very clear and meanwhile the questions are extremely well laid out. So I hope that we will have a complete clear answer on this aspect. So the additional things we will also discuss with the FDA are again very standard things. In other words the CMC part is a DGI study which you have to carry out in parallel with the Phase 3 program, all this having an objective to be ready when we have the readout of the Phase 3 study with all the additional activities you have to do around this pivotal study.

And then just on the new formulation, where is that currently? Is that been finalized, and when will we see the PK/PD data on the new formulation.

So this is a work which is progressing well and obviously we will have this data finalized before starting the Phase 3. So this I think is what I can say, but clearly yes, indeed as soon as this formulation work is finalized we will report on this without any problem.

[Operator Instructions] And I’m showing no further questions at this time. I’d like to turn the call back over to Remy Luthringer for closing remarks.

Really thank you everybody to be with us today and looking forward to speak with you very soon. Thank you again.

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