Minerva Neurosciences, Inc

Welcome to the Minerva Neurosciences third quarter 2020 conference call. At this time, all participants are in the listening mode. There will be a question and answer session following today's prepared remarks. This call is being webcast live on the investor's 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 Boney, Vice President of Investor Relations and Corporate Communications at Minerva. Please proceed.

Good morning. A press release for the company's third quarter 2020 financial results and business highlights 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 10Q 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. Remy Lutringer, Executive Chairman and Chief Executive Officer, and Mr. Jeff Race, Executive Vice President, Chief Financial Officer, and Chief Business Officer. Following our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption risk factors in our filings with the SEC, including our quarterly report on Form 10Q, the quarter ended September 30, 2020, filed with the SEC on November 2, 2020. Any forward-looking statements made on this call speak only as of today's date, Monday, November 2nd, 2020, 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 Lutheringer.

Thank you, Bill, and good morning, everyone. Thanks for joining us. I hope everyone is doing well. As we approach our meeting with the FDA on November 10, we remain enthusiastic about the potential of our lead product, Rolipiridone, and believe it will have a significant impact on the lives of patients with schizophrenia. Our confidence is based on our experience and the clinical database compiled to date with this compound. We are motivated to bring Roliparidone to patients as quickly as possible, as there is currently no approved treatment for negative symptoms, which remain the leading unmet need for patients with disease, their families, and their treating physicians. We announced the top-line results of the 12-week double-blind part of our Phase III study in May. Also, the study did not achieve its primary objective. Results obtained with a 64 milligram dose demonstrated the early onset of beneficial effect on negative symptoms that translated into functional improvements. Glodoperidone was also generally well tolerated in this trial with a safety profile comparable to placebo. Following that announcement, we have completed extensive analysis of data from this trial and others, including an integrated analysis of data from our Phase 2b and Phase 3 trials that shows a highly significant separation between the two doses of Roliparidone and placebo. In addition, we now have a large amount of data from the 40-week open-label phase of this trial, which is on schedule to complete in the first quarter of 2021. In late September, we provided these findings to the FDA in preparation for the Type C meeting scheduled for the 10th of November. During the forthcoming meeting, our findings will be discussed with the FDA, and we expect to receive the agency's feedback about the next steps in the development and potential regulatory approval of Roliparidone. We will provide a further update of our meeting once the minutes have been finalized by the FDA, which is expected in December. In summary, the recent Phase III data, combined with all of the data accumulated over the last few years, continue to support our belief that voluparidone can become an important treatment for schizophrenia patients. I will now turn it over to Jeff for the financial update.