Minerva Neurosciences Inc (NERV) 2015 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Minerva Neurosciences first quarter 2015 conference call. (Operator Instructions). This call is being webcast live on the investor section of Minerva's website at www.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 morning. A press release with the Company's first quarter 2015 financial results became available at 8 AM 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, our President and Chief Executive 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 the 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. Among the factors that could cause the 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, May 7, 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 morning, everyone. Thanks for joining us today. This quarter was an important period of continued progress across our pipeline, programs; bringing us closer to a number of upcoming milestones later this year. We strengthened our balance sheet significantly by successfully closing equity capital and debt financing. Our current financial resources will enable us to move forward with the development of all four of our clinical stage compounds, each with transformative potential, and key near-term milestones, which I will now outline in more details.

I would like to start with our lead asset, MIN-101, an innovative serotonin 5-HT2A and sigma-2 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. This compound has the potential to avoid the severe side effects of existing therapies, including sedation, extrapyramidal symptoms, plasma production increase, metabolic disorders, and weight gain.

Today, we announced that, to date, we have received regulatory approvals in Latvia, Estonia, Romania and Russia. And ethical committee approvals have been received in Latvia, Estonia and Romania with respect to our Phase IIb study for MIN-101. This multicenter, randomized, double-blind, parallel-group designed study will explore the effect of two doses of MIN-101, 32 milligrams and 64 milligrams, given once daily versus placebo in 234 stable schizophrenic patients with a history of negative symptoms. Enrollment has begun and is expected to continue through the last three quarters of 2015. We anticipate that top-line results for the core part of the study will be available in the second quarter of 2016.

I will now turn to MIN-202, 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. In March, we announced that we expect to initiate two additional studies for MIN-202 this year: a Phase IIa study in primary insomnia, and a Phase Ib in patients with major depressive disorder, or MDD, with comorbid insomnia. We expect to initiate both trials in mid-2015. These additional trials, built upon data reported earlier from a Phase I trial of MIN-202 conducted by Janssen, which showed that treatment with MIN-202 resulted in statistically significant improvements in sleep onset and sleep duration in patients with comorbid insomnia related to MDD.

Additional results from a Phase I bioavailability study and a Phase I multiple ascending dose study in healthy volunteers also suggests that MIN-202 is well tolerated and possesses advantages -- pharmacokinetic, pharmacodynamic features. We believe there is significant potential for MIN-202 in these indications. Importantly, we also believe it may be positively differentiated from other treatments by its unique mechanism of action, which aims to treat insomnia by controlling the activity of the neurons that promote wakefulness.

Turning now to MIN-117, our compound for major depressive disorder. We announced today that we plan to file an amendment to the protocol previously approved by the Latvian regulatory authorities for the double-blind, placebo-controlled Phase IIa study in patients with MDD. The amendment will request an additional patient arm that would evaluate a 2.5 milligram dose of MIN-117. If the amended protocol is approved, the study is expected to include a total of 80 patients, of which 20 would receive the open 5 milligrams dose of MIN-117, 20 would receive a 2.5 milligram dose of MIN-117, 20 would receive a 20 milligram dose of paroxetine, and 20 would receive placebo.

The additional arm would allow us to compare the relative improvement in symptoms between patients receiving 0.5 milligram and 2.5 milligram doses of MIN-117. We are on track to begin enrollment for the Phase IIa study in the second quarter of 2015 and expect top-line results of the study to be available in the first half of 2016.

Finally, moving to MIN-301, our investigational neuregulin-1 beta 1 compound for the treatment of Parkinson's disease. In January 2015 we announced that treatment with an analog of MIN-301 resulted in improvements in the range of symptoms associated with Parkinson's disease in primates. The analog used in the study differs from MIN-301 by a single amino acid. As a next step, we intend to file an IND or IMPD for MIN-301 in 2016, with an expected Phase I clinical study to begin following its acceptance.

In sum, we have made significant progress during the quarter across each of our four clinical programs and we are on track to achieve several upcoming milestones for each later this year, along with key value creating data readouts expected in the first half of 2016. We remain fully committed to our goal of becoming a leader in the development of novel CNS therapeutics, which is an area of tremendous unmet medical need for patients around the world.

I will now turn the call over to Geoff to cover our financial results.

Thank you, Remy. Earlier this morning, we issued a press release summarizing our operating results for the first quarter of 2015. A more detailed discussion of our results may be found in our quarterly report on Form 10-Q, also filed earlier today.

To start with 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 which we drew down $10 million. In March 2015, we completed a private placement whereby we issued approximately 6.3 million shares of common stock and warrants to purchase an additional approximately 6.3 million shares of common stock, resulting in net proceeds of approximately $28.5 million to us, net of transaction costs.

Cash and cash equivalents as of March 31, 2015, were $52.2 million compared to $18.5 million as at December 31, 2014. We expect our current cash will fund our operations through 2016. Research and development expenses were $4 million in the first quarter 2015, compared to $0.6 million in the same period in 2014. The increase was primarily due to program costs of $1.6 million related to MIN-101, $1.5 million in program costs related to MIN-202, and $0.3 million of employee compensation. General and administrative expenses were $1.9 million in the first quarter of 2015 compared to $2 million in the same period in 2014. The decrease was primarily due to lower consulting and professional fees, offset by increases in employee compensation.

Net loss was $6.1 million for the first quarter 2015 or a loss per share of $0.31, basic and diluted, as compared to net loss of $2.9 million or a loss per share of $0.43, basic and diluted, for the same period in 2014. We are pleased with our current financial position, which enables us to advance our drug development pipeline toward important milestones expected between now and the end of 2016.

Now I would like to turn the call over to the operator for any Q&A.

(Operator Instructions). Jason Butler, JMP Securities.

The first one on the MDD program, can you walk us through the rationale for including the higher dose? Is it based on preclinical data that you have supporting a higher dose, or do you have any receptor occupancy data that might support going to a higher dose?

Thank you for this question Jason. Yes, the rationale is definitely related to the pharmacology of the molecule and to some clinical pharmacology data, not only preclinical data but clinical pharmacology data. As you remember we have carried out a sleep study in healthy volunteers and as you know sleep is a very good biomarker of effects on mood. And clearly between 0.5 milligram and a dose which is close to 2.5 milligram, which was 3 milligram tested in this healthy volunteer study, we saw some differences, indicating that we are probably engaging more targets with the higher dose. So this is the reason why we added this dose.

Okay, great, that's helpful. And then for 301 in Parkinson's, should we expect any additional preclinical data in 2015 before you move into the clinic next year?

Yes, indeed. We are still awaiting some preclinical data coming out from the monkey study we did with the MPTP model, and we will soon report on this data when they are completely validated and QC'd.

Okay, great, that's helpful. Thanks for taking the questions and congrats on the progress.

Thank you.

Brian Skorney, RW Baird.

Good morning, this is Meg on for Brian. I just have a question. Based on the PK data from the MIN-101 formulations, do you expect a dose response between 32 milligrams and 64 milligrams?

Definitely. I mean I know we have a once-a-day formulation which was the objective of this (technical difficulty)size. It seems that clearly we have a dose-dependent effect when you are going to very low doses. We do not expect a huge difference between 32 milligrams and 64 mg milligrams, so these two doses should be having therapeutic effects.

Thank you.

(Operator Instructions). I am not showing any further questions at this time. I would like to turn the conference back over to our host.

Well, thank you all for your participation in today's call and we really look forward to updating you on the progress in the next coming months. Thank you.

Ladies and gentlemen, this does concludes today's presentation. You may all disconnect and have a wonderful day.

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