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Minerva Neurosciences, Inc. (NERV)

Q2 2016 Earnings Call· Sun, Aug 7, 2016

$6.45

+0.31%

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Transcript

Operator

Operator

Welcome to the Minerva Neurosciences' Second Quarter 2016 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 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

Management

Good morning. A press release with the company's second 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 Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the Securities and Exchange Commission on August 4, 2016. Any forward-looking statements made on this call speak only as of today's date, Thursday, August 4, 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

Management

Thank you, Bill and good morning everyone. Thank you for joining us today. I am very pleased to report that positive clinical data from two trials with MIN-101 in schizophrenia and MIN-117in major depressive disorder was the highlights of the second quarter of 2016 for Minerva.So the company is preparing to move forward into next stage of clinical development with these products. This data significantly strengthens the profiles of both compounds and underscore a significant potential to transform the therapeutic landscape in schizophrenia and major depressive disorder by addressing unmet needs of patients suffering from these diseases.2016 has been a highly productive year-to-date. Minerva had positive data readouts with three molecules MIN-101,MIN-117 and MIN-202 for four different trials. So company also completed a public offering of common stock, on June 17 resulting in net proceeds of approximately $53.7 million. These resources will support the continued clinical development of these three compounds as well as the preclinical development of MIN-301 for Parkinson's disease. Let me now review for you, our most recent data in more detail beginning with the MIN-101 Phase 2b study carried out in patients suffering from schizophrenia. A total of 244 patients were enrolled in our randomized placebo-controlled double-blind parallel-group design prospective Phase 2b clinical trial. The core study which was a double-blind treatment period of the trial was carried out over 12 weeks. So primary objective was improvement in negative symptoms in patients treated with two doses of MIN-101 32 and 64 milligrams administered, once daily in the morning compared to placebo. This improvement was measured by the change from baseline in the Positive and Negative Syndrome Scale, PANSS, negative subscale score calculated according to the pentagonal model over 12 weeks of treatment, 12 weeks being the primary end point. No approved treatment is currently available for…

Geoff Race

Management

Thank you, Remy. We issued a press release earlier this morning summarizing our operating results for the second quarter ended June 30, 2016.A more detailed discussion of our results may be found in our Quarterly Report on Form 10-Q filed earlier today. At June 30, 2016 the company's cash, cash equivalence and marketable securities were approximately $97.1 million compared to $32.2 million as of December 31, 2015.In January, February and June 2016 certain investors in the company's March 2015 Private Placement, exercise their warrants at an exercised price of $5.772 per share and received an aggregate of 3,850,051 shares of the company's common stock. The company received gross proceeds of approximately $22.2 million from the exercise of these warrants. In June, we completed an underwritten public offering of approximately 6.1 million shares of common stock at a price of $9.50 per share.Net proceeds to Minerva were approximately $53.7 million. Research and development expenses were $2.7 million in the second quarter of 2016 compared to $4.5 million in the second quarter of 2015. For the six months ended June 30, 2016, R&D expenses were $8.1 million compared to $8.4 million for the six months ended June 30, 2015. R&D expense in the three months ended June 30, 2016 and 2015 included non-cash stock-based compensation expenses of $0.2 million in both periods. Excluding stock-based compensation total R&D expense related to drug development programs for the three months ended June 30, 2016 and 2015 was $2.5 million and $4.3 million respectively, a decrease of $1.8 million. This decrease in R&D expense primarily reflects lower development expenses on MIN-202 as we fulfilled our funding obligation under the co-development agreement for the current development phase. The completion of the 12-week double-blind core phase of our Phase 2b clinical trial of MIN-101 and completion of our…

Operator

Operator

[Operator Instructions] Our first question comes from Jason Butler with JMP Securities. Your line is open.

Jason Butler

Analyst

Hi, thanks for taking the questions. I'm just wondering Remy obviously you said that you still need to wait for feedback from Regulatory Authorities but any thoughts you can give us on the design of the next study or studies from MIN-101 at this point?

Remy Luthringer

Management

Thank you, Jason. This is obviously a very interesting question. So I think what you’re contemplating currently is to try to see all the options because having in mind the really exciting results we have here. You have several options but the preferred option for the moment which has to be worked out which has to be discussed obviously with KOLs and Physio Authorities is to move forward with the same type of patients as of one's have been – who have been included -- sorry – in this Phase 2b study because really it is an unmet medical need. It’s a population who is not really deserved by existing therapies. And so it makes a lot of sense to counter disease population among other options because keeping in mind that our molecule is not only improving negative symptoms but has also an impact on other dimensions of the disease. You have several options open. We are working very hard on this and we will have much more clarity in the closed future.

Jason Butler

Analyst

Okay, great. And then just on MIN-202 just thinking about the path in MDD, when you think about the potential sedation effects, how you design a trial, is this something where you would expect dose in the evening or how do you anticipate managing the sedation effects of the drug in MDD – and not on insomnia population?

Remy Luthringer

Management

Yeah, this is also a like always a great question. So definitely the drug has to be given in the evening because keep in mind that I mean even so we have seen a direct effect on mood, one of the key features of the key symptoms, coma bit symptoms in depression is definitely insomnia. So clearly you would like to cover both and then it makes a lot of sense to give the drug in the evening. This said, when you are speaking about sedation I think this is not completely correct because keep in mind that if you're going the Orexin pathway and you're going to block some Orexin pathways, you are not activating the sedating pathways into brain. Like GABA pathway but you're really controlling the over activity in terms of vigilance control in the brain. So what the molecule like our molecule is doing, it is somehow bringing back to physiological levels the over activity of the wake systems into brain. So betterment again long story short, the drug has to be given in evening for sure.

Jason Butler

Analyst

Great, helpful. And then just a quick question for Geoff, I’m thinking about the fact that you’re now in a position where you’re preparing for additional clinical studies, is the R&D run rate we saw in 2Q reflective of what we’re going to see for the rest of the year or could the trend change meaningfully from that?

Geoff Race

Management

We don’t really give guidance on expense Jason. Thanks for the question. But I think you're right, what we saw in quarter two was tapering effect as the 101 2b study and 117 2a study began to read out and my current thoughts for the remainder of the year is that the run rate won’t significantly change. Obviously, we are beginning to prepare for later stage studies and there will be additional costs associated with CMC and regulatory work. But my current thought is not significantly.

Jason Butler

Analyst

Okay, helpful. Thanks for taking the questions and congrats on all the progress and results from the last quarter.

Remy Luthringer

Management

Thank you.

Operator

Operator

[Operator Instructions] I'm currently showing no further questions. I will now turn the call back over to William Boni for closing remarks.

William Boni

Management

Thank you everybody for joining us on this morning's call and we look forward to keeping you up-to-date as developments unfold in the coming months. Take care.

Operator

Operator

Thank you, ladies and gentlemen. That does conclude today’s conference. You may all disconnect. And everyone have a great day.