Welcome to the Minerva Neurosciences Second Quarter 2017 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.

Good morning. A press release with the company's second quarter 2017 financial results became available at 7:30 a.m. Eastern Time today and can be found on the Investor 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 us on the call today from 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 that 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-Q [Audio Gap] Any forward-looking statements made on this call speak only as of today's date, Thursday, August 3, 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, Will, and good morning, everyone. Thanks for joining us today. The second quarter of 2017 for Minerva was marked by progress in a number of key areas, including clinical development, business development and financing. This progress will support the company's clinical development pipeline, including the initiation of five planned clinical trials with three product candidates in the second half of 2017. Key recent accomplishments include an end of Phase II meeting with the U.S. Food and Drug Administration, focused on the design of our upcoming Phase III trial with MIN-101. The completion of a bridging study leading to the selection of an improved formulation to be used in this trial. The negotiation of an amendment to our codevelopment and license agreement with Janssen Pharmaceutical related to MIN-202, and the completion of a financing that expand our base of recognized institutional investors and significantly extended our financial run rate. We also have two investor calls with key opinion leaders. The discussions focused on unmet needs in schizophrenia and on the rationale for the design of the Phase III trial with MIN-101. Peer-reviewed recognition of our Phase IIb clinical data was additionally reflected in a publication by the American Journal of Psychiatry. I will review these activities beginning with MIN-101. Informed by feedback from the end of Phase II meeting with the FDA, we have confirmed the key elements of the Phase III trial design with MIN-101. To a significant degree, these parameters measure the design of our successful Phase IIb trial. So Phase III trial will consist of a three months randomized double-blind placebo-controlled core period followed by a nine months open label extension period. Approximately 500 patients will be randomized one to one to one, to two doses of MIN-101 monotherapy versus placebo. The primary outcome will be…

Thank you, Rémy. Earlier this morning, we issued a press release summarizing our operating results for the second quarter of 2017. 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 and marketable securities as of June 30, 2017, were approximately $77.6 million compared to $83 million as of December 31, 2016. Two recent events have had a positive impact on our cash position following June 30. The first of these was the amendment to the codevelopment and license agreement with the Janssen relates to MIN-202 that Rémy mentioned. This amendment and the stock repurchase provided for therein are conditional upon approval by the European Commission. Key financial terms of this agreement include cash payments to Minerva by Janssen of up to $70 million, including $30 million upfront, $20 million at the start of the Phase III insomnia trial with MIN-202 and $20 million when 50% of the patients are enrolled in this trial. In addition, Janssen will waive the remaining payments due from Minerva to the completion of Phase II development of MIN-202, which total approximately $13 million. The previous agreement provided that Minerva would contribute 40% of the Phase III development costs. Following execution of the amendment, Minerva will now assume strategic control of the insomnia program and accordingly all Phase III development costs. All Minerva stock currently owned by Johnson & Johnson Innovation, JJDC, Inc. totaling approximately 3.9 million shares and representing approximately 10% of total Minerva shares outstanding at June 30, will be repurchased by Minerva at par value of $0.0001 per share or approximately $389 in total. The second event that had an impact on our finances was our closing on July 6, 2017, of a public offering of…

Thank you. [Operator Instructions] Our first question comes from Jason Butler with JMP Securities. You may begin.

Thanks for taking the questions. Just a couple. First on MIN-101. Rémy, can you talk a little bit about the screening process and running process that you'll employ in the Phase III trial versus what you used in Phase IIb?

Thank you for the question, Jason. So basically the screening process is exactly the same. The only small difference is that when we are checking about the stability of the symptoms over a period of six months compared to three months, which was the case in the Phase IIb. But for the rest, I mean, the eligibility criteria is exactly the same as the duration of the bridging from the previous treatment to our treatment will be the same. So, all is really the same at the end of the day.

Okay. Great. And then for 117, just thinking about the potential benefit on anxiety. Do you have an estimate yet of what proportion of the MDD population has a significant level of anxiety as well?

Yes. So this is again a great question. I think the numbers are depending on the meta-analysis, which are done [indiscernible]. But I mean, what comes out is that the significant part of this population has definitely anxiety and there is something which is very important to keep in mind is that when you are initiating a treatment with an antidepressant and SSRI and SNRI or another treatment with a different mechanism of action, you have a period of time between initiation of treatment and the effect of mood where I mean, the patients are becoming quite anxious, as you know, the response we have today is a response to give some benzodiazepines and anxiolytics and this clearly demonstrated that this period is really how to say, key and I mean benzodiazepines are not helping a lot. So, I think there are two aspects, a significant part of patients with MDD have anxiety. And in addition, in order to get the best response to depression something different from benzodiazepines would be very beneficial. So this is the reason why we are so excited about having this effect on anxiety in the Phase IIb trial and to check this in the Phase IIb trial, I wanted to say Phase IIa before I said Phase IIb trial, which would start.

Great. And then just the last question for Jeff. In terms of EC approval of the 202 amendment, can you just speak to timelines there versus the August 31 deadline you have in the 10-Q. Can that deadline be moved at all? Or you're confident that you'll get something from the EC in August?

So we're talking to the EC at present and obviously, I can't give you an exact date as to when they'll be complete in terms of the review, but we expect it to be before the end of August.

Okay, great. Thanks for taking my question.

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

So thank you all for your participation in today's call, and we're really looking forward to updating you on our progress in the near future. Thank you so much and have a nice day.

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