Minerva Neurosciences, Inc

Welcome to Minerva Neurosciences' year-end 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. 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 Boney, Vice President of Investor Relations and Corporate Communications at Minerva. Please proceed.

Good morning. A press release for the company's fourth quarter and year-end 2020 financial results and business highlights became available at 7.30 Eastern Time today and can be found on the investor section of our website. Our annual report on Form 10-K 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 Lutheringer, 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 Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2020, filed with the SEC earlier today. Any forward-looking statements made on this call speak only as of today's date, Monday, March 8th, 2021, 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 today. I'm very pleased to present an update on progress and our earnings report for the full year 2020. In May last year, we announced top-line results from the double-blind portion of the phase 3 trial with Roliparidone in negative symptoms of schizophrenia. Although the study did not meet statistical significance, we remain highly encouraged by the promising signals that emerged. We look forward to sharing data from the Phase III nine-month open label extension, which will be available in the first half of this year. Following our Type C meeting with the FDA in November 2020, during which the FDA cautioned us that an NDA submission based on the Then current data from the Phase IIb and Phase III studies would be highly unlikely to be filed. We continue our dialogue with the agency. We are providing information to the FDA on several topics highlighted in the meeting minutes. Furthermore, we will also initiate a pivotal bioequivalence study in approximately 48 healthy volunteers, comparing the formulation employed in the Phase IIb and Phase III trials, as well as at least one new formulation designed in conjunction with our commercial supply partner, Catalan Inc., to facilitate large-scale manufacturing. We are working to address the FDA's requests and comments, and we are motivated by the agency's encouragement to continue the development of Roliparidone for the treatment of negative symptoms of schizophrenia. Among emerging therapies in development for negative symptoms, Roliparidone is the most clinically advanced, we remain committed to bringing Roliparadone as quickly as possible to patients in need of such a treatment. We are looking forward to 2020-wide with a significantly improved cash position following the recent sale of our rights to the self-directed royalty to Royalty Pharma, from which we received $60 million up front and will receive a further $95 million subject to the achievement of certain milestones. First, I would like to provide a more detailed update on our lead program, Roliparidone, a drug which has the potential to treat negative symptoms. Our primary objective in 2021 is to continue the development path forward to meet the regulatory requirements to submit an MDA for Roliparidone. First, the nine months open label extension of the phase three trial has been completed on schedule a few weeks ago. And I am happy to report that no patient was discontinued due to COVID-19 illness. The total of 333 patients, around 65% of those enrolled entered the nine-month open-label extension, in which those patients already being treated with Roliparidone remained on treatment on the same dose received in the 12-week double-blind phase, 32 mg and 64 mg. Those patients who received placebo in the 12-week double-blind phase were randomized to either 32 mg or 64 mg. We are very pleased that a total of 202 patients, around 61%, completed the open-label extension of the study. Data are expected to be available in the first half of 2021. These data are important because, as we observed in the Phase 2b six-month extension, they may demonstrate if improvement of negative symptoms is sustained or increased over the one-year duration, if improvement of negative symptoms leads to improved functioning, whether rolyperidone maintains or improves positive symptoms and or agitation, and whether the safety and tolerability profile of rolyperidone is maintained over the one-year administration period. I look forward to sharing a detailed presentation of the findings when data become available. In parallel, we continue to move forward with activities necessary to support the submission of a new drug application for roliparidone. First, we intend to initiate the bioequivalence study I described earlier. Importantly, we believe that by showing bioequivalence across formulations, we will address the specific comment made by the FDA about the Phase IIb formulation. Second, we are in the process of submitting the requested scientific literature in support of the psychometric properties of the primary and key secondary endpoints used in our clinical development, as requested by the FDA. Following the completion of the pivotal bioequivalence study, we plan to request a pre-MDA meeting with the FDA to discuss certain matters, including data from the phase three open label extension, data from the bioequivalence study, and potential NDA submission of Roliparidone for the treatment of negative symptoms of schizophrenia. I will now move on to recent developments in the cell direction program. You will remember that in mid-2020, Minerva exercised its right to opt out of a joint development agreement with Janssen, for the future development of Cell2Excent. As a result, we are entitled to collect mid single digit royalties on potential future worldwide sales in certain indications with no further financial obligations to contribute development costs to Janssen. On January 19 of this year, we announced that Royalty Pharma had acquired Minerva's royalty interest in Cell2Excent and that we received an upfront payment of $60 million, with the potential to receive up to further $95 million in additional payments contingent on achieving certain clinical, regulatory, and commercialization milestones. Cetorexone is currently in phase three clinical development by Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, for the adjunctive treatment of major depressive disorder with insomnia symptoms. We are delighted to have partnered with Royalty Pharma, the leader in acquiring pharmaceutical royalties across the life science industry. It has enabled us to secure significant non-dilutive funding, both immediate and potentially over the long term, that will support our top priority, the continued development of Roliparidone, our lead asset. In summary, we remain committed to developing Roliparidone as a potentially transformative treatment in the treatment of the negative symptoms of schizophrenia. I look forward to sharing data from the Phase III Open Label Extension with you soon and the Pivotal Bioequivalent Study in the coming months, as well as continuing to update our investors on the ongoing dialogue with the FDA. I will now turn it over to Jeff to discuss our financial performances.