Minerva Neurosciences, Inc.
Q1 2017 Earnings Call Transcript

Published: 6 May 2017

[Operator:]

Welcome to the Minerva Neurosciences’ First Quarter 2017 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, Vice President of Investor Relations and Corporate Communications at Minerva. Please proceed.

[William Boni:]

Good morning. A press release with the company's first quarter 2017 financial results became available at 7

[Remy Luthringer:]

Thank you, Bill, and good morning, everyone. Thanks for joining us today. Today, I will briefly discuss the latest step in the advancement of MIN-101 on its clinical development paths. I am pleased to report that Minerva recently has an end of Phase II meeting with the U.S. Food and Drug Administration, during which we discussed the current MIN-101 package, particularly the Phase IIb results we obtained in patients with a diagnosis of schizophrenia with negative symptoms and the Phase III IV clinical development of MIN-101. We shared with the FDA the complete package of clinical, pre-clinical and CMC data generated to date with MIN-101. Our discussion included as well the potential content of our Phase III and Phase IV development plan, particularly focusing on the target population and study design including primary and secondary outcome measures which might be adverse. We plan to initiate Phase III development of MIN-101 in schizophrenia in the second half of 2017. The meeting allowed us to share our view on the potential contribution of MIN-101 as a new treatment paradigm for people diagnosed with schizophrenia and not functioning well due to the presence of negative symptoms. The considerable amount of recent scientific literature is being accumulated reinforcing the facts of negative symptoms is the target of MIN-101 represents a significant unmet need for patients, the families of patients and physicians. These symptoms contribute substantially to both quality of life and functional outcomes for the large worldwide population of patients suffering from this disease. I will move on with brief comments on our other programs. Our second clinical stage compound is MIN-117 in development to address unmet medical needs in patients suffering from major depressive disorder, MDD. Based upon clinical and pre-clinical findings, we believe MIN-117 may demonstrate the safety profile comparable to placebo while avoiding many typical side-effects of current MDD treatments including cognitive impairment, sexual dysfunction, sleep disorders and weight gain. Following the acceptance of the investigation of new drug application, IND for MIN-117, Minerva is planning clinical trials with its compound in the U.S. and Europe. Planning is underway for these trials, which are expected to begin in late 2017. Our third clinical stage compound is MIN-202, a selective orexin 2 receptor antagonist, such as developing in partnership with Janssen Pharmaceutica NV Janssen. Based on positive clinical data generated last year, MIN-202 is being targeted for the treatment of both insomnia without neuro-psychiatric comorbid symptoms and comorbid insomnia in patients suffering from depressive disorders. Supportive activities and clinical pharmacology studies are currently being carried out in anticipation of the next efficacy studies with our compound in both indications. Finally, our pre-clinical stage product candidate is MIN-301 to treat Parkinson's disease. MIN-301 is a recombinant protein with extra-cellular domain of Neuregulin 1 Beta, primary activating the ErbB4 receptor. This regulation of the NRG1 signaling pathway has been linked to neurodevelopmental and neurodegenerative disorders including and beyond Parkinson’s disease. The next plan steps in the MIN-301 program are the timing of an IND in the U.S. or an investigational and medicinal product dossier IMPD in Europe and pending acceptance by regulatory authorities initiation of Phase I clinical testing thereafter. In summary, we recently held an end of Phase II meeting with the FDA, which helps us to design the Phase III clinical development of MIN-101. We look forward to sharing details of our development plan when finalized. I will now turn the call over to Geoff to cover our financial results.

[Geoff Race:]

Thank you, Remy. This morning we issued a press release summarizing our operating results for the first quarter of 2017. A more detailed discussion of our results may be found in our quarterly report on Form 10-Q filed with the SEC earlier today. Net loss was $10.6 million for the first quarter of 2017 or a loss per share of $0.30 basic and diluted, compared to a net loss of $8 million, or a loss per share of $0.29 basic and diluted, for the same period in 2016. Research and development expenses were $7.6 million in the first quarter of 2017, compared to $5.4 million in the first quarter of 2016. R&D expenses in the three months ended March 31, 2017 and 2016 included non-cash stock based compensation expenses of $0.5 million and $0.2 million respectively. This increase in R&D expenses primarily reflects higher development expenses under the MIN-202 program for Phase II clinical trial preparation and an increase in non-cash stock based compensation expenses. These amounts were partially offset by lower costs, due to the completion of our Phase IIb clinical trial of MIN-101 and the completion of our Phase IIa clinical trial of MIN-117. General and administrative expenses were at $2.9 million in the third quarter of 2017, compared to $2.4 million in the first quarter of 2016. G&A expenses in the three months ended March 31, 2017 and 2016 include a non-cash stock based compensation expenss of $0.8 million and $0.6 million respectively. This increase in general and administrative expenses was primarily due to an increase in legal and professional fees, an increase in non-cash stock-based compensation expenses, and increased personnel costs during the three months ended March 31, 2017. Cash, cash equivalents and marketable securities as of March 31, 2017 were approximately $85.4 million. Since December 31, 2016, warrants with respect to approximately 1.6 million shares were exercised by certain institutional stockholders for proceeds of $9.3 million received by the company. The warrants were issued in connection with a private placement that took place in March 2015 and they expired on March 20, 2017. The company believes that its existing cash, cash equivalents and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months. Now, I would like to turn the call over to the operator for any questions. Operator?

[Operator:]

Thank you. [Operator Instructions] Our first question comes from the line of Jason Butler of JMP Securities. Your line is now open.

[Jason Butler:]

Hi, thank you for taking the questions. Just first one on MIN-101, do you – have you received the meeting minutes back from the FDA yet? And is that point at which you plan to be able to provide giving updates on trial design? Or do you think you're going to need additional interactions with FDA before finalizing the Phase III program? Thanks.

[Remy Luthringer:]

Jason, thank you for the question. So what we're doing at this point, we are really interoperating the feedback we received during the meeting into our Phase III development plan and we’d really expect to announce details of the plan in a very near future. So this is what we are currently doing.

[Jason Butler:]

Okay, great and then just a question on MIN-202. When do you expect the next clinical trials to begin? Could that still be in 2017?

[Remy Luthringer:]

Yeah, yeah, so clearly I mean those – to be very clear those preparations submission work and [indiscernible] is currently ongoing. So the trials will really start all-in 2017 definitely, Jason.

[Jason Butler:]

Okay, great. Thanks for taking the questions.

[Remy Luthringer:]

You're welcome, Jason.

[Operator:]

Thank you. [Operator Instructions] And I'm showing no questions at this time.

[Remy Luthringer:]

I guess I have to conclude. So I wanted to thank you all for your participation of today’s call and we are really looking forward to update you very soon on our progress. So, thank you again everybody.

[Operator:]

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program. You may now disconnect. Everyone have a great day.