Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2018 Earnings Conference Call Transcript

Nov 05, 2018 • 08:30 am ET


Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2018 Earnings Conference Call Transcript


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Welcome to the Minerva Neurosciences Third Quarter 2018 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 Boni, VP of IR and Corporate Communications at Minerva. Please proceed.

William Boni

Good morning. A press release with the Company's third quarter 2018 financial results 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 SEC this morning and can be found on the SEC's website at www.sec.gov.

Joining me today on the call from Minerva are Dr. Remy Luthringer, Executive Chairman and CEO; Mr. Geoff Race, EVP, CFO and CBO; and Mr. Rick Russell, President. Following our prepared remarks, we will open the call for Q&A.

(Forward-Looking Cautionary Statements)

I would now like to turn the call over to Remy Luthringer.

Remy Luthringer

Thank you, Bill and good morning, everyone. Thanks for joining us today. Over the past quarter, I am pleased to report that momentum has continued to build in each of the five late-stage clinical trials that are underway with three Minerva product candidates. These trials include the Phase 3 trial with roluperidone, MIN-101 for the treatment of negative symptoms in patients suffering from schizophrenia. The Phase 2b trial is MIN-117 for the treatment of major depressive disorders, MDD associated with anxiety and three Phase 2b trials with seltorexant, MIN-202 for the treatment of insomnia disorders and major depressive disorders.

Recruitment of patients in the Phase 3 trial is ongoing with our lead product, roluperidone. We plan to enroll a total of approximately 500 patients at approximately 60 clinical sites in the US and Europe. This randomized, double-blind, parallel-group, placebo controlled 12-week trial is designed to evaluate the efficacy and safety of 32 milligram and 64 milligram of roluperidone as monotherapy in other patients suffering from schizophrenia.

The primary endpoint of this trial is a change from baseline in negative symptoms using the Positive and Negative Syndrome Scale, PANSS, Marder's negative symptoms factor score, NSFS over the 12-week double-blind treatment periods. After the 12-weeks, patients enter into a 40-week open label extension period during which source on active drug during the double-blind phase continue to receive the original dose, while patients on placebo are randomized to receive either 32 milligram or 64 milligram effective drug if they elect to enter the extension period.

Key secondary endpoints includes the Personal and Social Performance scale, PSP and Clinical Global Impression of Severity, CGI-S. This trial is addressing the significant unmet medical need, negative symptoms for which no treatments are approved. As we stated in this morning's press release, momentum continues to build in the enrollment of patients in our Phase 3 clinical trial with roluperidone.

We are nearing