Minerva Neurosciences, Inc

Welcome to the Minerva Neurosciences third quarter 2021 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 would now like to turn the call over to Jeff Race, President of Minerva. Please proceed.

Good morning. A press release with the company's third quarter 2021 financial results and business highlights 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 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. Fred Auerholm, Chief Financial Officer. Following our prepared remarks, we will open the call for Q&A. Before we begin, I'd 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. Those 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 September 30th, 2021 filed with the SEC earlier today. Any forward-looking statements made on this call speak only as of today's date, Monday, November the 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 Lutringer.

Remy Lutringer Thank you, Jeff, and good morning, everyone. Thanks for joining us today. I would like to focus this morning's update on our lead program, ROLI paradigm. On September 30th, 2021, we announced the results from a pivotal bioequivalence study where the results met key pharmacokinetic objectives and demonstrated bioequivalence across the various formulations. We call the objective of this study was to compare the formulations employed in the Phase IIb and Phase III trials, as well as a planned commercial formulation designed in conjunction with our commercial supplier to facilitate large-scale manufacturing. In this type of study, the area under the curve to last detectable concentration, AUC last, the area under the curve extrapolated to infinity, AUC infinity, and the maximum plasma concentration, Cmax, are the most commonly used plasma pharmacokinetic parameters to evaluate bioequivalence between various formulations. For roliparidone, Our earlier work has shown that efficacy in patients with negative symptoms of schizophrenia is mostly driven by plasma exposure of the drug, i.e. AUCs, whereas safety margins improved by reducing Cmax of the drug. Furthermore, as ronipiridone is intended for chronic use and the assessed formulations are controlled release, AUC infinity is the most relevant of the AUC measurements when single-dose data are collected and used for determining bioequivalence. In this study, the two most important objectives were to establish, firstly, the comparability on the fasted conditions of the 64-mg tablet of the Phase III formulation of proliferidone compared to the 64-milligram dose based on the administration of two 32-milligram tablets of proliferidone used in the Phase IIb study. And secondly, the comparability and the fasting conditions of a 64-milligram tablet of the planned commercial formulation of proliferidone compared to the 64-milligram dose based on the administration of two 32-milligram tablets of proliferidone used in the Phase IIb study. The data showed that both objectives were met. The AUC infinity were bioequivalent and the Cmax of the reformulated phase three and planned commercial formulations had been reduced substantially compared to the phase two B formulation. In this study, we also demonstrated bioequivalence in terms of AUCs and Cmax between the 64 milligram formulation of the planned commercial tablets and the phastic conditions compared to the formulation used in the phase three. And bioequivalence both in terms of AUC infinity and Cmax of the 64 milligram dose of the planned commercial formulation and the fed and phastic conditions. In summary, I believe the bioequivalence study results represent important progress along Minerva's critical path towards submission of an NDA for roliparidone. Moving on to our recent correspondence with the FDA. Last week, we announced that the FDA had denied the company's request for a pre-NDA meeting for roly-peridone and proposed that the type C guidance meeting would be more appropriate. Therefore, the company plans to request the type C meeting. And so to conclude my update this morning, the successful completion of the bioequivalent study represents an important component of the NDA package. Subject to the timing of and feedback from the FDA, we continue to work towards the submission of a new drug application in the first half of 2022. Finally, I would like to take this opportunity to welcome Dr. Ramana Kuchibatla as our new head of R&D at Minerva. I will now turn it over to Fred for the financial update.