Minerva Neurosciences Inc (NERV) 2014 Q4 法說會逐字稿

Welcome to the Minerva Neurosciences fourth-quarter and year-end 2014 conference call.

(Operator Instructions)

This call is being webcast live on the investor section of Minerva's website at minervaneurosciences.com. As a reminder today's call is being recorded.

I would now like to turn the call over to Joe Reilly, Chief Operating Officer at Minerva. Please proceed.

Good afternoon. The press release with the Company's fourth-quarter 2014 financial results became available at 4 p.m. Eastern Time today and can be found on the investor section of our website.

Joining me on the call today from Minerva are Dr. Remy Luthringer, Chief Executive Officer, President and Chief Scientific Officer, and Mr. Geoff Race, Executive Vice President and Chief Financial 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 provision 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.

Among the factors that could cause actual results to differ materially include the initiation, timing, cost, progress and success of our research and development, preclinical studies and clinical trials, developments relating to our competitors and our industry including the success of competing therapies that are or may become available, our ability to advance product candidates into and successfully complete clinical trials and other factors identified from time to time in reports filed with the Securities and Exchange Commission. Any forward-looking statements made on this call speak only as of today's date, Thursday March 26, 2015, and the Company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today's date.

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

Thank you and good afternoon everyone. Thanks for joining us today. I am very pleased with Minerva's accomplishments over the past year and with the past three months in particular which lay the groundwork of the numerous upcoming milestones across our lead programs and broader pipeline.

As we have discussed our goal is to be a leader in the development of novel CNS therapeutics. This is an area of tremendous unmet medical need and we believe we have made important progress over the past year.

We currently have four clinical stage compounds in development each with transformative potential and each with key near-term milestones. Together we are working with large pharma partners including Janssen Research & Development, one of the Janssen Pharmaceutical companies of Johnson & Johnson and Mitsubishi Tanabe. I'm also very pleased to be working with a world-class team both within the Company and in our network of consultants, key opinion leaders and advisors to bring these products forward.

With that, let me now turn to our pipeline. Let's start with progress on our lead asset MIN-101, an innovative serotonin 5-HT2A and Sigma2 receptor antagonist which we are evaluating in schizophrenia. MIN-101 has shown strong efficacy on negative symptoms and the broader spectrum of schizophrenia symptoms including positive symptoms, cognitive impairment and sleep disorders and has the potential to avoid the severe side effects of existing therapies including sedation, extrapyramidal symptoms, plasma prolactin increase, metabolic disorders and weight gain.

In December we announced the completion of development and the final selection of a once-daily dose formulation of MIN-101 which we intend to use in our planned Phase 2b clinical trials in schizophrenia. In Europe we submitted an application to run a multicenter randomized double-blind parallel group design study in the fourth quarter of 2014 and we are very pleased to announce that we have received the first regulatory approval in Latvia and the first ethical committee approvals in Latvia and Estonia to start this trial.

The study is exploring the effect of two doses of MIN-101, 32 milligram and 64 milligram, given once daily versus placebo in 234 stable schizophrenic patients with a history of negative symptoms. Patients will receive treatment once daily for three months followed by an optional extension of six months. The primary efficacy endpoint will be to evaluate the differences from placebo of negative symptoms after the three-month treatment period as measured by the change from baseline in PANSS positive and negative syndrome scale.

The BNSS, brief negative symptom scale, will also be applied to further explore effects of MIN-101 on negative symptoms. We plan to also investigate the effects and positive symptoms and overall symptoms of schizophrenia measured by PANSS and the clinical mobile impression rating scales. Cognitive function, sleep and improvement in function will be explored as well as secondary measures.

Clinical and biological safety and plasma pharmacokinetics will also be part of the study. Enrollment is expected to occur over the last three quarters of 2015. We anticipate top-line results in the second quarter of 2016.

While we plan to initially develop MIN-101 as a first-line monotherapy during potential Phase 3 trials for MIN-101 we may also explore co-administration with atypical antipsychotics. We believe there is also an opportunity and a strong scientific rationale to use MIN-101 in other neuropsychiatric diseases outside of schizophrenia like severe mood or neurodegenerative disorders.

Now turning to the next product in our pipeline, we also have exciting updates to report for our insomnia compound MIN-202 for which we will be initiating two new studies in mid-2015. MIN-202 is our selective orexin-2 receptor antagonist under development in collaboration with Janssen Research & Development, one of the Janssen Pharmaceutical companies of Johnson & Johnson for the treatment of primary and comorbid insomnia. Its unique mechanism of action aims to treat insomnia by controlling the activity of the neurons that promote wakefulness.

In January 2015 we reported preliminary results from a Phase 1 placebo-controlled clinical study conducted by Janssen showing the treatment with MIN-202 resulted in statistically significant improvements in sleep onset and sleep duration in patients with comorbid insomnia related to major depressive disorders MDD. Additional results from a Phase 1 bioavailability study and the Phase 1 multiple ascending dose study in healthy volunteers also suggested that MIN-202 is well tolerated and possesses advantages pharmacokinetic pharmacodynamic features.

The first of the two new MIN-202 studies is a Phase 2a study in primary insomnia which is expected to initiate in mid-2015. Also in mid-2015 we expect to initiate a Phase 1b trial in patients with MDD with comorbid insomnia.

Minerva has an exclusive co-development agreement with Janssen and exclusive commercialization right for this molecule in Europe. We have recent important progress to report in our broader CNS portfolio as well which includes MIN-117, for major depressive disorders, and MIN-301, for Parkinson's Disease.

Today we announced that we received ethical committee approval in Latvia for a Phase 2a study of MIN-117 in 60 patients which we plan to begin enrolling in the second quarter of 2015. This will be a randomized double-blind parallel group placebo and active control study to evaluate the efficacy and safety of MIN-117, 0.5 milligram in patients with MDD.

The primary objective is to evaluate the efficacy of MIN-117, 0.5 milligram compared to placebo in reducing the symptoms of a major depressive episode as measured by the change from baseline in the Montgomery Aspect Depression Rating Scale, MADRS, total score over six weeks of treatment. Safety and tolerability of MIN-117 will also be explored in comparison to the active control Paroxetine given add the therapeutic dose of 20 milligram per day.

Finally moving to MIN-301 our investigation of neuregulin-1 beta 1 compound for the treatment of Parkinson's Disease. In January we announced results from a Primomed use of PRIMate MOdels to support translational medicine nonhuman primate study that showed treatment with an analog of MIN-301 resulted in improvements in a range of symptoms associated with Parkinson's Disease. Animals treated with a daily subcutaneous injection of the MIN-301 analog showed a protective effect of our molecule against MPTP induced tremor measured by the abnormal involuntary movement scale AIMS and decreased motor control measured by the Bungalow test compared to vehicle.

Results were also consistent with previous research in rodent models of Parkinson's Disease that has shown that MIN-301 has the potential to restore motor function. As a next step we intend to file an IND or IMPD for MIN-301 in 2016 with an expected Phase 1 clinical study to begin promptly thereafter.

So to summarize we have made a lot of progress since our initial public offering and we are excited that we expect to initiate four clinical studies in 2015 with pivotal milestones in late 2015 through mid-2016. Now I will turn the call over to Geoff to cover our financial results for the fourth-quarter and full-year 2014.

Thank you, Remy. Earlier this afternoon we issued a press release summarizing our results of operations for the fourth-quarter 2014. A more detailed discussion of our results may be found in our annual report on Form 10-K filed earlier today.

To start with our cash position, cash and cash equivalents as of December 31, 2014 were $18.6 million compared to $1.8 million as of the prior year. Earlier this year we took steps to further strengthen our cash position.

In January 2015 we entered into a term loan with Oxford Financing LLC and Silicon Valley Bank for up to $15 million. Under this agreement we drew down $10 million in January, 2015. In March 2015 we raised net proceeds of approximately $28.8 million through the issuance of 6.3 million common shares with 100% warrant coverage in a private placement.

Our current cash is anticipated to fund our operations through 2016 excluding any proceeds which may be received in connection with the exercise of the words issued in our recent private placements. Research and development expenses were $3 million in the fourth quarter of 2014 compared to $200,000 in the same period in 2013 and $42.9 million for the full year ended December 31, 2014 compared to $700,000 in the same period in 2013.

These increases were primarily due to increased cost related to our four drug development programs including a $22 million license fee paid to Janssen under the co-development agreement from MIN-202 and increased costs for salaries and stock compensation expense related to additional staff hired during 2014. General and administrative expenses were $4.5 million in the fourth quarter of 2014 compared to $1.9 million in the same period in 2013 and $12 million for the full-year ended December 31, 2014 compared to $2.5 million in the same period in 2013. These increases were primarily due to increased costs related to our operation as a public company and increased costs for salaries and stock compensation expense related to additional staff hired during 2014.

Net loss was $7.4 million for the fourth quarter of 2014 or a loss per share of $0.40 basic and diluted as compared to a net loss of $2.1 million or a loss per share of $0.41 basic and diluted for the same period in 2013. For the full year ended December 31, 2014, net loss was $56.9 million or a loss per share of $4.47 basic and diluted as compared to net loss of $3.3 million or a loss per share of $0.78 basic and diluted for the same period in 2013. In short, we are quite pleased with our financial position as we have the resources to take our pipeline forward to important milestones in the near term.

Now I'd like to turn the call over to the operator for any questions and answers. Operator?

(Operator Instructions) Brian Skorney, Robert W. Baird.

Hey, good afternoon guys. Thanks for taking my questions.

I guess starting on MIN-101 so you said that enrollment will occur over the last three quarters of 2015 in the Phase 2b study. Should we read that to mean that you're expecting enrollment to complete by the end of this year and if that's the case, should we expect data in the first half next year or is it more mid-2016? And can you also just review the powering assumptions on the endpoint in that study?

Pardon me, speakers, your phones may be on mute.

I can hear you operator. Let me start that, Brian, hi, it's Geoff. Hopefully Remy will join in a second.

So to go to your first question about enrollment that's exactly right. We are now expecting to enroll patients into this study over the final three quarters of 2015. We expect to have enrolled all patients by the end of the year.

This is of course a three-month study as you'll recall. So the last patients into the study at the end of this year will obviously receive three months treatment which will take us into the end of the first quarter, beginning of the second quarter. And we can expect top-line data in the middle of 2016.

So to go to your second question about powering I think we probably need Remy to respond to that. I'm hoping he's back on the line.

Can you hear me?

Yes.

So thank you, Geoff. Yes, Brian the powering of the study is based on the results we obtain in the Phase 2a study. So we expect the difference between placebo and treatment on the negative symptoms score of the PANSS scale of 3.5 points and the powering is of 90% so this is the assumptions we have on the primary endpoint.

Great and then just real quick on the MIN-117. Can you just give us thoughts on the rationale for looking at the 0.5 mg dose as opposed to doing some additional dose exploration in the Phase 2a?

So this is a very good point. So we have worked quite a lot on the dose finding both in the preclinical and the clinical pharmacology studies with healthy volunteers and all is pointing towards the fact that very low doses are very effective in what we would like to demonstrate. First of all quicker onset or a very quick onset in terms of reversing mood and also in what is really the unmet need as well which is improvement of cognition and sexual function and again at very low doses are working with 0.5 milligram or an equivalent of 0.5 milligram if you're going back to the animal studies.

So this is a rationale why. As you know it is very important to have an extremely safe drug for an antidepressant because this in some cases might be a chronic treatment and really to have a very safe drug, well-tolerated drug and the drug improving some condition and sexual function is very important. So this is the rationale behind the selection of this 0.5 dose.

Great, thanks guys.

(Operator Instructions) With no further questions in the queue I would like to turn the call over to Remy Luthringer for closing remarks.

So really thank you to all for your participation in today's call and we really look forward to updating you on our progress in the next coming months. Thank you all and have a nice evening.

Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation.

You may now disconnect. Everyone have a great day.