Minerva Neurosciences, Inc

Welcome to the Minerva Neurosciences second quarter 2021 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 investor section of Minerva's website at ir.minervaneurosciences.com. As a reminder, today's call is being recorded. I'll now like to turn the call over to William Boney, Vice President of Investor Relations and Communications at Minerva. Please proceed.

Good morning. A press release with the company's second quarter 2021 financial results and business updates 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, 2021, filed with the SEC earlier today. Any forward-looking statements made on this call speak only as of today's date, Monday, August 2, 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 Lutheringer.

Thank you, Bill, and good morning, everyone. Thanks for joining us today. Following the completion of the open-label portion of the phase three trial with Roliparidone in schizophrenia and the type C meeting with the FDA, Minerva continues to work towards the submission of a new drug application in the first half of 2022. Towards that end, we have completed enrollment in a pivotal bioequivalent study with Roliparidone in Healthy Volunteers. We also continue to make progress in assembling the components required to submit an MDA for Roliparidone, including clinical pharmacology, non-clinical MCMC activities. We anticipate completing these activities over the coming months and we look forward to continuing our dialogue with the FDA in anticipation of submitting a request for a pre-NDA meeting. Let me begin with a biofilm study. On April 23, 2021, we initiated subject screening in this study conducted in Healthy Volunteers. The objective of this study is to compare the formulations employed in the Phase IIb and Phase III trials as well has at least one new formulation designed in conjunction with our commercial supplier to facilitate large-scale manufacturing. We are seeking to demonstrate similar drug exposure between the formulations. On June 29, 2021, we completed the enrollment of 48 subjects in this study. We look forward to reporting the top-line results, which are expected in the third quarter of 2021. In parallel with completing the bioequivalent study, we are working on additional activities required to support an NDA submission for roliparadone. These activities are informed by our interactions with the US FDA since the type C meeting last November. The rationale for NDA submission was strengthened by the findings from the open label extension. In summary, these findings were supportive in several key areas. First, they demonstrated a specific and continuous improvement in negative symptoms among patients who received monotherapy with roniparidone throughout the duration of the nine-month open lipid extension period as measured by the MARTA negative symptom factor score. Second, this improvement was correlated with functional improvement as measured by the personal and social performance scale. The observed relapse rate of approximately 12% compares favorably with relapse rate of more than 25 to 30% seen in the schizophrenia literature. Finally, the extension data showed that Roliparidone was well tolerated with no weight gain, extra-primitive symptoms, prolactin increase, or sedation. In summary, we believe that the completion of the bioequivalent study will represent an important component of the NDA package. We are encouraged by our ongoing interaction with the agency, and we believe we have addressed nearly all of the issues raised at our Type C meeting last November. We are also making excellent progress towards the completion of the NDA. Following a successful bioequivalent study, we plan to request a pre-NDA meeting with the FDA to discuss the NDA content and readiness for submission. I will now turn it over to Jeff for the financial update.