Minerva Neurosciences, Inc

Welcome to the Minerva Neurosciences second quarter 2020 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. The call is being webcast live on the investor sections 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 second 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 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. Remy Luthringer, 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 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 3, 2020. Any forward-looking statements made on this call speak only as of today's date, Monday, August 3, 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 Luthringer.

Thank you, Bill, and good morning, everyone. Thanks for joining us. I hope everyone is doing well. Today I will focus primarily on Minerva's lead product, Voliparadone, which recently completed the double-blind part in a phase 3 trial for the treatment of negative symptoms in patients suffering from schizophrenia. The significant unmet medical need is the main reason why patients with schizophrenia suffer from diminished function, and it places a huge burden on patients, their families, and the Health Care System. Today, there is no approved treatment for negative symptoms in the United States. Based on the review of the Phase III data, which builds on the Phase IIb data, as well as additional data we have compiled over the years, we continue to believe that Rolipiridone has the potential to be the first drug to improve negative symptoms directly and specifically. After giving an update on rhodoperidone, I will also discuss the cell direction program and our decision to opt out of the co-development agreement with Janssen Pharmaceutica. Today I would like to begin with an update on the review of data from the recent phase 3 trial of rhodoperidone. The trial evaluated two doses of rhodoperidone, 32 and 64 mg, over 12 weeks. The study was carried out in about 60 clinical sites in the U.S., Europe, and Israel. More than 500 patients were included in the trial. Following the 12-week double-blind phase, patients were offered an additional nine-month extension period of treatment with Roliparidone on either 32 or 64 milligrams. I'm pleased to report that over 300 patients entered the extension and more than 100 patients have now completed the overall one-year treatment period. I'm also very pleased to report that only a limited number of patients dropped out of the studies as a result of worsening of positive symptoms. This continues to be observed to date in the nine-month extension. So, what have we learned about rhodoperidonex schizophrenia from this trial so far? Statistically significant differences were observed for the primary endpoint, the negative score proposed by Steve Marder, NSFS, negative symptoms factor score extracted from the PAM scale between active doses and placebo at week 4, both doses, and week 8, 64 mg only. Both groups receiving active treatment showed numerically superior improvements in NSFS to placebo at week 12, also the placebo improvement was higher throughout the phase three trial compared to the phase two B trials. We believe this may be why statistical significance was not achieved at week 12. Functional improvement as measured by the personal and social performance scale or PSP was statistically significantly superior with the 64 milligram dose at all assessed weeks with nominal p-value of 0.021 at week 12. We continue to explore the drivers behind the improvement of negative symptoms and consequently functional improvement by looking at this core component of negative symptoms, and we suspect it is largely driven by a meaningful improvement in the patient's level of abolition or lack of interest or engagement in goal-directed behavior. So what is next? Once we complete our additional analysis of the Phase III data, we will be requesting a meeting with the FDA to discuss our data package and the path forward for rhodoperidone's development. I would now like to address our second clinical stage program, celtorexant, Mn202. On July 1, 2020, we announced that we exercised our right to opt out of our agreement with Janssen for the future development of celtorexant. As a result, Minerva will collect royalty in the mid single digits on worldwide sales of cell direction in all indications with no financial obligations to Janssen moving forward. So the decision to opt out of the agreement at this stage of the program enables us to retain a meaningful financial interest in the future revenue stream of a compound with significant commercial potential in multiple indications. At the same time, It eliminates the company's obligation to make significant financial payments to fund the large Phase III program. Our decision to opt out will enable us to align our human and financial resources with our primary focus to seek approval of our lead company, Wally Peridon, and to help those patients for which there is currently no effective treatment. Before handing over to Jeff to give you the financial update, I would like to restate our conviction that Lovoperidone has significant potential to be the first drug approved to treat negative symptoms. This conviction is based on our growing understanding of negative symptoms and the recent Phase III data combined with the data that we have accumulated over the past few years. This encouraging data combined with an innovative mechanism of action and favorable safety profile gives us confidence in the future of body paradigm. Body paradigm remains an important program both for the potential benefit of patients and their families and a significant commercial opportunity to effectively treat negative symptoms in schizophrenia and beyond. I will now turn it over to Jeff.