Earnings Labs

Minerva Neurosciences, Inc. (NERV)

Q1 2016 Earnings Call· Tue, May 3, 2016

$6.45

+0.31%

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Transcript

Operator

Operator

Welcome to the Minerva Neurosciences First Quarter 2016 Conference Call. [Operator Instructions] 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 William Boni, Vice President of Investor Relations and Corporate Communications at Minerva. Please proceed.

William Boni

Analyst

Good morning. A press release with the company's first quarter financial results became available at 7.30 AM 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 Internet website at www.sec.gov. Joining me on the call today from Minerva are Dr. Remy Luthringer, President and Chief Executive Officer; and Mr. Geoff 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 including without limitation whether any of our therapeutic products will advance further in the clinical trials process; whether, when, and to what extent results from such trials will be available, and whether and when if at all such products will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies, and for which indications whether any of our therapeutic products will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management's ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; the sufficiency of our current cash position to fund our operations and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption 'Risk Factors' in our filings with the SEC, including our Annual Report on Form 10-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission on May 3, 2016 Any forward-looking statements made on this call speak only as of today's date, Tuesday, May 3, 2016 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.

Remy Luthringer

Analyst

Thank you, Bill and good morning everyone. Thanks for joining us today. During the first quarter of 2016, we reported [indiscernible] top line data from two trials with MIN 202, our selective orexin 2 antagonist, and the co-development with Janssen Pharmaceutica. This included a Phase 2a trial in patients suffering from primary insomnia disorder and the Phase 1b trial in patients having the diagnosis of major depressive disorder or MDD. We also recently reported the last patient visits in two additional trials including the Phase 2b trial in schizophrenia with MIN-101 and the Phase 2a trial in major depressive disorders with MIN-117. Those results from both studies are expected later in the second quarter of this year. In all of our clinical programs, our primary goal is to address significant unmet needs in the treatment of large patient populations affected by this diseases. Let me know address those trials in more detail beginning with MIN-101. A total of 244 patients have been enrolled in our randomized placebo-controlled double blind pilot group design Phase 2b clinical trial to treat unmet needs in patients suffering from schizophrenia. The primary objective of the trial is to evaluate two doses of MIN-101, 32 and 64 milligrams administered, one daily in the morning compared to placebo in improving negative symptoms in these patients as measured by the chance from baseline in the positive and negative syndrome scale. Negative subscale score of the pentagon model of 12-weeks of treatment. Important secondary objectives include assessments of the effect of MIN-101 on the total pan score and sub scores, as well as its effect on cognition and sleep. The course study which is a double-blind treatment period of the trial was carried out over 12-weeks, thereafter; patients had the opportunity to enter into an extension period lasting six…

Geoff Race

Analyst

Thank you, Remy. We issued a press release earlier this morning summarizing our operating results but the first quarter ended march 31, 2016, a more detailed discussion of our result may be found in our quarterly report on Form 10-Q filed earlier today. At March 31, 2016 the company's cash, cash equivalents, and marketable securities were approximately $44.6 million compared to $32.2 million as of December 31, 2015. During the first quarter of 2016, the company received approximately $17.5 million in proceeds from certain existing shareholders who exercise warrants granted in connection with a private placement in March 2015. Warrants were a total of approximately 3 million shares of common stock were exercised at an exercised price of $5.77 a share. Also during the first quarter the company ended it into a common stock purchase agreement with Dr. David Kupfer, a Director under which the company sold to Dr. Kupfer 181,488 shares of the company's stock at a price per share of $5.51 or gross proceeds of approximately $1 million. Research and development expenses were $5.4 million in the first quarter of 2016 compared to $4 million in the first quarter of 2015. Research and development expense in the three-month period ended March 31, 2016 and 2015 included non-cash stock-based compensation expenses of $0.2 million and $0.1 million respectively. Excluding stock-based compensation, total research and development expense related to drug development programs for the three-months ended March 31, 2016 and 2015 was $5.2 million and $3.9 million respectively. This increase in research and development expense primarily reflects increased expenses related to our Phase 2b clinical trial of MIN-101 and our Phase 2a clinical trial of MIN-117. General and administrative expenses were $2.4 million in the first quarter of 2016 compared to $1.9 million in the first quarter of 2015. General and administrative expense in the three-month period ended March 31, 2016 and 2015 included non-cash stock-based compensation expenses of $0.6 million and $0.3 million respectively. Excluding stock-based compensation, general and administrative expense for the three-months ended March 31, 2016 and 2015 was $1.8 million and $1.6 million respectively. Net loss was $8 million for the first quarter of 2016 for a loss per share of $0.29, basic and diluted compared to a net loss of the $6.1 million dollars or a loss per share of $0.31 basic and diluted for the same period in 2015. The proceeds generated from the recent warrant to exercised strengthened our financial position, and as a result, we expect that our cash, cash equivalents and marketable securities will be sufficient to fund Minerva's operations into the second quarter of 2017. Now I'd like to turn the call over to the operator for any questions.

Operator

Operator

William Boni

Analyst

Well, thank you everyone. I hope we addressed a lot of the issues you had in mind and we look forward to providing you with updates on our anticipated progress in the coming months. Thank you very much for attending.