Q1 2020 Earnings Call
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Ladies and gentlemen, please standby your confidence scheduled to begin momentarily. Thank you for your patience.
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Welcome to the whenever Neurosciences first quarter Twentytwenty conference call.
At this time, all participant lines are not listen only mode.
They'll be a question and answer session. Following today's prepared remarks.
This call is being webcast live on Investor section I. When I was left site at <unk> Dot Minerva Neurosciences Dot com.
As a reminder, today's call is being recorded I.
I would now like to turn the conference over to William Boni, Vice President Investor Relations in corporate communications that Minerva.
Please proceed.
Good morning.
A press release with a company's first quarter 2020 financial results in business highlights became available at 730 years in 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 Securities and Exchange Commission. This morning, and can be found on the Fccs website at Www Dot ASCII Si Dot Gov.
Joining me on the call today for Minerva are Dr., Remy Luthringer executive Chairman and Chief Executive Officer.
Mr., Rick Russell, President and Mr., Jeff race, Executive Vice President Chief Financial Officer, and Chief Business Officer.
Following our prepared remarks, we will open the call for Q1 day.
Before we begin I would like to remind you that todays discussion will include statements about the company's future expectations plans and prospects in constitute forward looking statements for purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act.
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 current expectations and may differ materially from actual results due to a variety of factors that are more fully.
Tailed under the caption risk factors in our filings with the FCC, including our quarterly report on form 10-Q for the quarter ended March 31st 2020 filed with the FCC on May four 2020.
Any forward looking statements made on this call speak only as of today's date Monday may 4th 2020, and the company disclaims any obligation to update any of these forward looking statements to reflect events or circumstances that occurred after today's call except as required by law.
I would now like to turn the call over to Remy Luthringer.
Thank you Bill and a good morning, everyone. Thanks for joining us I hope everybody is doing one.
Today, It would focus on me nervous to advance can you could stage products, London ever done which is in a pilots in phase three trial and sent directions, which has completed phase to be testing.
Hello to pair with them to be a rapidly approaching the company's ki bin for 2020.
The result of topline results expected this quarter from over phase three trial resist component to treat negative symptoms of schizophrenia.
Such risks and evaluating along with a partner young so Thomas Utica and number of protocols for phase three trials.
I will begin with Roger parent.
It's a phase two trends are randomized double blind pilot group Gazyva controlled 12 week study to have a likely efficacy and safety of search. He told me to ground and 64 milligram dose yourself voted Perry done as measured by the positive and negative symptoms.
The primary endpoint is a milder negative symptoms talk to score.
They're endpoints includes a personal and socially performance came and clinical global impression of severity.
As we announced last February a total of 515 patients have been and go didn't just try and clinical sites in the U.S. a jewel.
It's a patients had been randomized one to one one to surgery to meeting where I'm at 64, Big lump those who supported paradigm and placebo.
So quotes for a week double blind phase of the trials you spoke about you for to be open label extension period during which patients on the drugs has the option to continue receiving that Virginia, those and patients on placebo may received one of the two doses afforded parent.
Well listen just try to has been and affected today basically we're in a virus epidemic.
The continuity monitoring each trial site and have a contract research organizations to ensure safety for patients and access to study drug.
The last patient visit has taken place into htwo be double blind phase of the trial.
I'm pleased to report said in total 362 patients have completed to double blind phase 333 patients from the double blind phase heavy elected to transition into the open label extension period and 92 patients have completed the extension phase as of April searches 2020.
We look forward to the database lock and beginning of data analysis, they just months.
So design of the phase three trial has been informed by feedback from the FDA beginning with the upper end to face to meeting and subsequent communication with the agency.
It's probably not goal of negative symptoms of schizophrenia has been decreasing the highlighted by the key opinion leader community since we initiated a phase three trial.
In fact, I would give up on the front apparel done has been shaped by your fundamental view of schizophrenia.
While positive symptoms present intermittently during the course owns a disease negative symptoms persist and worsen over the lifetimes owns a majority of patients it's us civilian emitting functional ability and preventing the social and vocational integration.
So longer term.
No drug are currently approved to treat the negative symptoms of schizophrenia or negative symptoms present in other conditions, including they've looked that is orcas affective disorders, and Georgia genetic disorders.
You are excited about the possibility of the phase three data addressing these significant unmet medical need and pointing has a way to a new treatment paradigm for negative symptoms beginning with schizophrenia.
Moving onto centric so you're looking to build upon just three positive phase to be trials and one phase one be trying to compete it during 2019.
As we plan to phase three program for this promising company.
Results of those trials sorts itself direction has positive effects on some yet patients we sell co morbidity, including elderly patients who is a favorable safety profile.
Patients with major depressive disorder, and D D, who do not respond adequately to assist the rise in essence <unk> Rice said directed also showed improvements in mood Bucks cloudy patients we did some.
The current target indication under consideration for phase three is that genco treatment of MDD in patients with insomnia symptoms.
We and our partner young some are discussing feedback received comes the U.S.M.D.A. During a recent interface to meeting into the phase three development strategy, including several clinical protocols to support that indication.
Oh discussion with Johnson also include decision, making control of the program and the achievement of defined milestones under our agreement.
Before I conclude I would like to offer a few additional thoughts about draw dependent.
There's a best of I wouldn't Polish really paradigm is the only druck, having shown today, especially pick and direct improvement the primary negative symptoms in a randomized double blind placebo controlled phase to be clinical trial.
Additional data analysis from that study showed that patients also improve in terms of commission more than functioning. Thus further demonstrating what we believe all as a unique qualities of this I jumped.
The most emerging therapies in development for negative symptoms really pair with only the most clinically advanced into phase three trial has been designed to test its efficacy as monotherapy versus placebo up sends a couple Dick effects of caught me situation. It was actually because antipsychotics.
They're excited about the possibilities for wrote a pair of done as we plan to shares a topline results from the phase three trial not too distant future.
We know turn it over to Jeff.
Thank you Remy.
Earlier. This morning, we issued a press release summarizing our operating results for the first quarter ended March 31st Twentytwenty.
A more detailed discussion of our results maybe found in our quarterly reports on form 10-Q filed with the FCC earlier today.
Cash cash equivalents restricted cash and marketable securities as of March 31st Twentytwenty were approximately $37.6 million compared to $46 million as of December 31st 2019.
We present, they expect out the company's existing cash and cash equivalents will be sufficient to meet this anticipated capital requirements for at least the next 12 months from today and into mid late 2021 based on our current operating plan.
The assumptions upon which this estimate is based on routinely evaluate it and maybe subject to change.
Research and development expenses were $8.1 billion in the first quarter of Twentytwenty compared to $11.6 million in the first quarter a 29 team.
The decrease in R&D expenses, primarily reflects lower development expenses for the phase three clinical trial of Brody paradigm under phase to be clinical trial of mineral and one seven.
R&D expenses are expected to decrease during twentytwenty with the completion of the phase Twob trial of many warm on seven.
And the 12 week double blind portion of the phase three clinical trial of wrote a corridor.
General and administrative expenses were $4.2 million into first quarter, twentytwenty compared to $4.7 million into first quarter of 29 Threed.
This decrease in DNA expenses was primarily due to a decrease in noncash stock based compensation expenses and the decrease in professional fees.
Net loss was $12.2 million for the first quarter of Twentytwenty.
Or a loss per share of 31 cents basic and diluted compared to a net loss of $15.8 million for the first quarter 2019, or a loss per share 41 cents basic and diluted.
Now I'd like to turn the call over to the operator for any questions operator.
Thank you.
Asked the question at this time, you would need to press Star then one on your telephone to withdraw your question. Please press the pound King again that is star then why if he would like to ask the question.
Our first question comes on the line of Jason Butler with JMP Securities. Your line is now open.
Hi, Thanks for taking my <unk>.
Questions I.
Remy I know you talked about this before but with the data perella paradigm fast approaching just wondering if you could reminders of the Oh, the baseline characteristics you've seen in the phase three trial and applying to basis versus what you had in the phase two trial, and then give us an update and what you've seen again on a blind to basis in terms of.
Positive symptom relapse. Thanks.
Hello, Jayson Hello, everybody. So so clearly I mean, oh he knows the what we head into phase to be was oh or negative symptoms of on the 25 points a baseline.
And Oh Jeez Trues up I mean, we are monitoring of the she's a phase three completely blinded by merging together all the patients who Anderson study and a I have to say that we are ending up is exactly the same entries color in terms of negative symptoms, which is obviously a great using sometime I couldn't even give you a little.
More granularity or having goes up I mean, what we see over the first the 12 weeks didn't just double blind phase he term stuff.
She behavior and the dining becomes a negative score he's really overlapping between.
The two studies the phase to be interface, we know concerning zee.
Relapses.
No. So those are you gain of one point, which is a debate about what he's always ups, but I mean, a what I can tell you is that comparing again or.
The things to be phase, three or so and I love Synopsys. We can see he is a limited and these are in line or between the two studies.
Great and then just one more for me can can you just speak a little bit too to where you are in your commercial preparations and what your.
Goals are to achieve throughout this year as as you ramp back towards a potential launch next year.
So maybe I can give this a little bit to Rick Rick Yes, if some words.
But you have your question Tony.
Yes, sure so hi, Jason Good morning, So a couple of things here. So first of all you may recall, we've already.
Signed a commercial supply agreement with Katelyn I'm. So, we'll obviously continue the work to be ready to have commercial supply.
I will.
Watch we've also received conditional approval from F.D.A. portrayed game, we havent release that yet we will sometime in the future once the data reads out positively.
We'll enter more kind of formal dialogue with potential co promote partners. There's a number of companies that already have established relationships with them psychiatry, you're in the U.S. market. So I think we're we're quite interested to reach out and talk to some of those folks and see if we could essentially a wide with some of the tubs.
Interesting infrastructure and do a co promote with with someone like that.
Great. Thanks for taking questions around looking for to the data.
Thank you Jason.
Thank you. Our next question comes on the line of Joel Beatty with Citi. Your line is now open.
Hi, Thanks for taking the questions.
First one is on data integrity, you know there had been an issue. They came up around late last year. So I guess, you're just to confirm for the 362 patients that's completed a double blind study.
I've got to be review that you'll you'll have data I know the official.
Hi, Joe Yes.
Tail it clearly no impact on data integrity or they explained in one of the previous calls.
You know this most impacted the speed likud or we could screen in the and include patients in the study a randomized patients the study but.
Because we took it was a person precautions friends are beginning to have for example to our because of a lot samples onsite a watershed send it to two to to be analyze temporarily and one kept them site. I mean, we really did not experience any and the impact.
But then what happened.
A few months ago. So so clearly a very clearly or is this a 362 patients can be fully analyzed.
And a maybe a one word about cobiz because I guess you see those are very hot topic. So no impact to probably does we as we mentioned the regularly over the past.
Terrific and I guess a question here given that there's two dosing arms could you remind us of the stats plan.
This is a great question that sounds like the first of all that being a one one interesting point is that the even if it didn't look requested we shared our statistical analysis plan with the with the F.D.A.S. and the received feedback which.
Oh really confirmed as a way the we would like to analyze the data we will analyze the data because it's no becoming [laughter] the reality is.
But that's as a statistical analysis plan is that I T T or using the M. O'brien approach and Oh, he's corrected for type one that road busy horsburgh correction. So basically what it means is that occur as the primary endpoints you're pursuing the comp the reason.
Between a placebo and that's the highest dose of 64 meeting room, you feel heating or the P values are high person significance. So you can do the I'm, obviously, that's a second those that'd be the same.
5% of value for P and if not you have to divide by too.
As a P value for the second do it wasn't that basically says mean took I mean, it's no longer p. 0.05, but it will be PZ <unk> 0.0, Ptwenty five in order to claim that certainly two milligram is significant.
So this is the strategy, which might delay was the same we use the interface to be us.
Because as you remember suffice to be has the internalized like a registrational study.
Got it yeah that makes sense, then maybe one last question and sell trucks and.
It sounds like you had discussions what I see on that program going ahead. If it does could you talk about how the cost would it be split for the not part of development.
I guess I give this over to Jeff suggest can you can you answer this question. Please.
Sure Yeah.
The agreement is very clear in terms of Ah each party's responsibilities with regard to funding to the phase three part of the program.
Back in 2016, we were required to amend the agreement that we have with.
With the on some of the result of a European Commission intervention in connection with the European in some of your market on the I clearly in a transaction, which J.R.J., we're seeking to get approval for.
At that time, but basically the amendment to the agreement or.
Requires been a that too.
Cover the a full cost of the insomnia phase three program JJ will give a 40 million dollar contribution to the phase three in some of your program and then on the other side on the a and B D program.
We split the cost 40% minute of 60% Jane Jay.
Great. Thank you.
Welcome.
Thank you next question comes from the line healthier in Atlanta with Jefferies. Your line is now open.
Yeah, Hi, guys. Thanks for taking my questions. So Remy in the press release it seems that.
You have a 30% dropout rate is is that how we should think about.
Ill patients that have completed trial versus enrolled and whether yeah. How does this number of compare to what your assumptions were for the trial design and I guess, where there any imbalances across the three arms in terms of dropout rate.
[noise] those last question I cannot answer because just how these blinded to best.
The first one was first like an unfair so so the assumption. So if you remember where 40 person.
Dropout over the first 12 weeks, another double blind phase and and we ended up we certainly person drove both which if you remember it's really blind with what we had interface to be up basically so.
Since this is good you'll just because we have less lipids and what we had the number or powering assumptions.
Okay, and then on the patients.
That completes the open label I think you have to 92 patients. They have completed open label expansion can you tell us anything.
About these patients when they came into the open label versus one they exited <unk> are you able to look at that data.
Given its open label data to see what the changes or benefits were in terms of negative symptoms in these patients.
Yeah sure. So that's just keep in mind doesn't mean or you know the patients who have been uncertainty two milligram or will stay on social media Grandmaster pests, and 64 will stay on 64, and Andy placebo patients on a going into the open label John randomized to as one of the to those just so we don't know today.
What is a dose of patients hurting us I mean, the but but who knows I have no placebo, but we don't know, but you do they have been term stuff.
Going apparent on but yes, indeed, obviously we are following.
These patients are as he knows its primary objective of these extensions to takes a book so so.
100 patients exposed the two who's a drug for one year or so this is really the safety aspect, but this is what you have to do a.
The textbooks to go for the engine or to go to the FDA, especially I think this in Grady extremely good use because if we have still a lot of patients going on do you ever ready 92 have completed so I think we are really good shape for taking these books. So well just before the end just patients in terms of safety and efficacy.
And without having as much detail details as opposed to double blind phase I seem to just things Oh behaving in terms of efficacy like it was interface to be as well. So so so far so there was this and that really a shortened season.
Okay, and then maybe a question on itself right there.
What are the key gating item so starting the phase three and do you anticipate.
Starting a phase three this year.
So so I'll just say, we recently had he said and different trace to meeting with our colleagues from Johnson and Johnson and and we got a several feedbacks. So does this meeting was obviously really concentrating on focusing on on the on the mbd indication.
Hi, I means a key question was up two new or you are these patients who are responding batteries insomnia AWS or primary population. So so this is a signal really clarify.
What was also ER plaintiff discussions are going more into the details boards or how did you quantify.
In some yes.
Objective, we only subjectively or and objectivity and those this has been clarified sorry.
As we speak this protocols have are adopted them to finalize the ER and as a feasibility theyre going on but as you know.
With the Koby, the and then make as the Feasibilities are more complicated. So we are working on it or and how soon as we are ready we will we would give you more details but there. So this is a.
Well this current young going but a little bit a slower than expected due to the because according to pandemic.
Okay, and then maybe just a lot of question what are your thoughts on R&D expenses once the phase three finishes.
How do you know I have I have a lot of idea that's on the and I think the good news or is that that may not if I mean, we have enough positive data was a voluntary done we have really are a lot of things. We can we can do or insides schizophrenia indication and as you know because then they go.
If you've seen terms our RIDEA.
Are these trends do you have no sticker symptomatology your retrieved in a in several different these orders into space psychiatry, and even urology [noise].
We will obviously it or are working on or is this so as of today, we have a put together those are perfect world and there.
We end up puts us into too. Many studies. So we are currently discussing internally pacing whats advice from some accountable care when it was or what would be the priorities to two studies to do or after topline results. So pay a little bit with us we all your brainstorming, they're coming up with the best a way moving forward that I mean, it maybe lumber.
The two or three or very exciting studies, we have in mind, which I think we'll first before I cover or Highview unmet medical need them debruin creates a lot of ideally uncertain. Because this is or what you have in mind and and beyond that really paradigm I think we we have going so a plan.
<unk> place in order to move forward.
Obviously to work on the center of Excellence program, but also to move forward. The Ziad somebody towards you know pipeline, so I love to come or but again that are working procon progress.
But I think we have a lack of clarity you know just priorities to to be made.
Great. Thank you.
You know most welcome.
Thank you as a reminder to ask the question really need to press Star then one on your telephone.
Our next question comes on the line of mild winter with William Blair. Your line is now open.
Hi, guys.
Congrats and thanks for taking the questions just remedied last time, we talk just start for a month.
Or you might mention that I covered Don team not going to impact the topline data potentially the.
Portion.
I'm wondering if you got any more clarity into the types of delays, we may or may not expect there and if there are they the U.S. sought specifically or are these broad and across the entire a quote global nature, if that trial I got a follow up after that thanks, Yeah, Yeah, Yeah, Myles so I.
I guess, what I say that cause a moment, we have no impact on the extension the due to cobiz, but obviously I cannot predict what will happen moving forward this but.
As of end of last month cycle, we had no impact offer Colby this oh on columns extension so.
Which is good news and ER and I think it'd be really puts in place. So we have been extremely reacted and they have to say that that means the guidelines coming out from here good year, MBA Hezbollah, but you have been extremely reactive or reduce our COO role and we just sites.
Two rady incremental order or what is possible in order to continues to the exploration in terms of safety and.
And the efficacy for it if I see evaluation, sorry for the patients or as you remember actually gotten where you also discuss about the fact that we have in each country you have enough drug kicked into country. So so this will not have an impact too.
Due to bring good luck to each patient the reserve in the extension them to each side, obviously, so so far so good Oh, we continued somebody told me a very interactive we obviously are using the again, they're supposed to be these given by the advisory Yeah, you and the guidelines about for example.
Remote monitoring just kind of things, but ER or again today, we have no impact to us.
As we speak.
Oh, sorry, as a last point about the U.S., So last point about U.S. or if the book this one.
Remember that I mean, U.S. started before the European sites and clearly I mean, we have a rig it limited number of for a few aerospace was taken can extension there. So so I think.
We will not have the problem Uh huh.
In the U.S. was extension as well so so definitely I mean, I really up to the U.S. was a monkey.
Sorry, it would be set aside at that 92 patients that have complained about extension phase I significant proportion off them, our invade U.S. patients.
It's a mixed a it's a mixed but I mean, clearly as the first one when completed or the 12 month.
I'm, so sorry, yes definitely.
Are coming from the U.S., India.
Okay Cool and then just some seltzer wrecks and I'm curious in the press release, you you make mention Youre chasing this it jumped to empty day indication comorbid insomnia.
But you didn't mention about the insomnia program alarming.
So I'm wondering whether or not MD day is taking the priority here, obviously janssen plays a lot potty not and then.
Obviously with MD gauge hospital shape, our responses a crucial to the outcome studies Charles I'm wondering whether the placebo response rates in patients that it came over with insomnia defects adores without and whether that's for lighted so like background medications like self today, Matt and things like that they space.
Just five to tighten coming into that potential trial just.
Okay, great questions like go away. So so clearly clearly I think.
ER.
As a tool the two indications.
Our apostle former fiber objective objectives to move forward, but I mean, Xie Xie Xie insomnia date, I mean in patients without any comorbidities, where superior let me just as a straightforward process I mean, there clearly are remember we had the.
Greedy a very nice data, even though you know those and didn't elderly and do our batches and the standards affairs, and openness and and and the Tolerability profile was excellent. So so that you hear me to a it's a quite easy pass forward. This will mean that no no no really big surprise white was a little bit more tricky obviously.
Was the G.M.D.D. indication because it clearly.
When you have the complain if insomnia.
And a and B D or Calea means a response is much better.
No doubt about because he sees data driven or is there is no doubt that but it doesn't mean the these patients are responding or better and then you're looking to the possesses a teaser rate to respond to.
It's a delta between the between treatment and placebo I mean, just becomes media very very significant but very very meaningful yes, I do want to say clinically meaningful because I I don't know she says clinically meaningful that at minimum just patients are doing much much better is when supposed to having some the NMD d.
So this is a this is the reason why it took a little bit longer to think about what was just maybe in terms of huh.
Let's see but response I have no I didn't know defined did I answer to your question because I think we did not best with my knowledge, maybe my colleagues in R&D did it and this will be happy to report if you've had many it has been done the later.
But item there havent notion of having a different placebo response as you know placebo response is how you select the patients on how your run your trial so.
But but I have no no no good knowledge about the is ever difference, but what is clear is that the when you're looking again to the difference we have seen between treatment and placebo Ebola patients have been somebody in addition to their MDD disorder.
You know as a result, no doubts that that media the read rocky such here. So so I'm I'm very confident that said moving forwards we will not really struggled with the placebo.
Effect, what what took what is important I think two dimensional this is a much more generally commons and.
Which is going be onsite directionally is that a single visit current ongoing academic I think as the patients suffering from M.D.D. has probably not the same phenotype.
Zen or what we have seen before as a pandemic and I think we'd have to single it's a hard about what could happen. After I'm done against because as you know people are losing a joke people are more stressed people are more anxious for people. So I think it does this is something we have to reconsider but when we are running again the depression trial. So but does this is a.
Maybe another debate the more generally debate, but I think we are really consider exists.
Because I think it it becomes important and maybe maybe this is just expectation.
The insomnia per meter will be even more importantly after considering.
That's fair thanks for the questions.
Welcome.
Thank you. Our next question comes on line of Douglas Tsao with H.C. Wainwright. Your line is now open.
Hi, good morning, Thanks for taking the questions just quickly in terms of how long do you think or you know once you get the 100 patients for the team imminent any extension how quickly can would you be in position to file the NDA for rollout Parago and just given the timing of to read out for phase three thank you.
They'll get.
This as you know I mean, it's it's not a ethical to stop and you patient if he stays enters us into the trial until the end till the end of the 12 months or so so basically.
As the I mean, some of this last patients are completed to double than say anything to the extension. So so it's as these patients are staying in the into 12 or so nine months holdings as other banks Hazel you know to teach the books of 12 months I mean, they will go through the end than the and so is it sort of the extension data will be get.
There are many we will get probably would get much more tons of 100, we need it we need to particular bucks about safety as the extension has to be completed so this will happen.
You know beginning of next terrorists or in the first quarter smoking. So so clearly we cannot transition, but so what we will do as you know and this is not becoming more and more common to that yet gay is really very old and perhaps just 'cause it's kind of pre pre NDA meeting this and we xchanging on a regular based busy with the.
Yea end.
When we have the topline results. We will obviously shares this was yesterday just because it was yesterday and Oh my colleague or just how would the who's in charge of R&D. It has a has really worked a lot than we have a lot different outputs. In addition to the.
Primary and secondary endpoints in order to really understand fully understands the data. So we will be will digest. All this hopefully based on positive data and we will start to work as you have good but again.
We need to go through the end of the extension to have the companys packages so for the ending.
Okay, great. Thank you.
Welcome.
Thank you. This concludes today's question and answer session I would now like to kind of all back around me like window for closing remark.
Yeah. Thanks, so much so thank you everybody for.
Listening to each other our earnings cool.
It is obviously a very important moment for the company. We are very close notes was the result of lots of work a lot of hope for patients and co pretty I love for value creation car.
For our shareholders. So I just want Brady looking forward to update you very very soon about our phase three results. Thank you all and have a very nice day.
[noise], ladies and gentlemen. This concludes today's presentation. Thank you once again for your participation you may now disconnect have a great day.
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Well go to the one.
The first quarter 40 topic, let's call.
At this time.
Right.
Hello.
I will be a question and answer session following todays remarks.
This call is being webcast live on the especially when I was website at <unk> are that.
Hi.
As a reminder, today's call is being recorded.
I would now like to Charles <unk>, <unk>, William Boni, Vice President Investor Relations in corporate communications that one or <unk>.
Please proceed.
[music].
Good morning.
Yes release, what the company's first quarter 2020 financial results and business like.
Became available at 730 years am Eastern time today I can be found on the investor section of our website.
Our quarterly report on form 10-Q was also filed electronically with the Securities and Exchange Commission. This morning.
I can be found on the Fccs website at Www Dot ASCII Si dot Gov.
Joining me on the call today for Minerva are Dr., Robert <unk>, Executive Chairman and Chief Executive Officer.
Mr., Rick Russell, President and Mr., Jeff race, Executive Vice President Chief Financial Officer, and Chief Business Officer.
Following our prepared remarks, we will open the call for Q1 day.
Before we begin I would like to remind you that today's discussion will include statements about the company's future expectations plans.
Plans and prospects that constitutes forward looking statements for purposes of Safe Harbor provisions under the private Securities Litigation Reform Act.
Like T 95.
We caution that these forward looking statements are subject to risks and uncertainties that may cause actual results could differ materially club. 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 that are more fully.
Tailed under the caption risk factors.
Filings with the FCC, including our quarterly report on form 10-Q for the quarter ended March 31st 2020 filed with the FCC on May four 2020.
Any forward looking statements made on this call speak only as of today's date Monday May four 2020, and the copy disclaims any obligation to update any of these forward looking statements to reflect events or circumstances that occurred after today's call except as required by law.
I would now like to turn the call over to Remy Luthringer.
Thank you Bill and good morning, everyone. Thanks for joining us I hope everybody is doing what.
Today, It would focus on me nervous to advanced clinical stage products ever done which is in a private the phase three trial and such Rex out we just completed phase to be testing.
Well the teradata rapidly approaching the company's key events for 2020.
The result of topline results expected this quarter from our phase three trial was this compound to treat negative symptoms of schizophrenia.
Such risks and evaluating along with.
John said from a strategic huh.
Number of protocols for phase three trials.
I will begin with Roger parent.
It's a phase three trial is a randomized double blind pilot books Gazyva controlled 12 week study to have a likely efficacy and safety of subject to let me dig Wellnesssixty told me to gum those itself well to terrorism.
Measured by the positive and negative symptoms.
The primary endpoint is a milder negative symptoms strive to score.
Secondary endpoints includes a personal that social performance coding and clinical global impression upset by Ritchie.
As we announced last February.
515 patients have been involved in just trial at clinical sites in the U.S. a jewel.
It's a patients had been randomized one to one to one to surgeons limited where I'm at 64 big lump those used up all the paradigm and let's see.
So called twice a week double blind phase of the trials you spoke about your 40 week open label extension period during which patients on the drugs have the option to continue receiving that Virginia, those and patients on placebo may receive one of the two doses afforded Perry.
Oh listen just trial has been an effect gets to date I used to coordinate virus epidemic.
Yes continuity monitoring each trial site and our contract research organizations to ensure safety or patients.
Just to study drug.
The last patient visits has taken place once or twice a week double blind phase of the trial.
I'm pleased to report said in total 362 patients have completed to double blind phase 333 patients from the double blind phase had elected to transition into the open label extension period and 92 patients have completed the extension phase odds with April search just 2020.
We look for whats the database lock and beginning of data analysis, they just months.
So design of the phase three trial had been informed by feedback from the FDA beginning we end the face to meeting and subsequent communication with the agency.
It's probably not a goal of negative symptoms of schizophrenia has been decreasing the highlighted by the key opinion leader community since we initiated a phase three trial.
In fact, I would develop wonderful apparel done has been shape onto that's our view of schizophrenia.
Like positive symptoms present intermittently during the course of the disease negative symptoms are safe and worsen over the lifetimes owns a majority of patients. That's civilian let me think functional ability and preventing social and vocational integration.
As a longer term.
No Draco currently approved to treat the negative symptoms of schizophrenia, all negative symptoms present in other conditions, including they loved that is artless affective disorders, and Georgia tenants you'd be zones.
You are excited about the possibility of the phase three data addressing these significant unmet medical need and pointing the way to a new treatment paradigm for negative symptoms beginning with schizophrenia.
Moving on to set direct so you're looking to be the buttons are three positive phase to be trials and one phase one be trying to compete it during 2019.
As we plan to phase three program towards this promising company.
Results of those trials sorts itself directs and thats positive effects audience. Some young patients we sell co morbidity, including elderly patients who is a favorable safety profile.
Patients, whose major depressive disorder, M.D., who do not respond to the equated to assess the rise in send the rice said direction also showed improvements in mode. That's cloudy patients missing something.
The current target indication under consideration for phase three is adjunctive treatment of MDD in patients with insomnia symptoms.
We and our Papa young so I'll discuss inc. feedback received from the U.S.M.D.A. During a recent interface to meeting into the phase three development strategy, including several clinical protocols to support that indication.
Oh, just specialties Jaeson also include decision, making control of the program and achievement of defined milestones under our agreements.
Before I conclude I would like to offer a few additional thoughts about draw the parent.
There's a best of I wouldn't alleged repairable easy only dropped had been shown today, especially pick and direct improvement the primary negative symptoms in a randomized double blind placebo controlled phase to be clinical trial.
Additional data analysis from that study showed that patients also pulled in terms of commission more than functioning. Thus further demonstrating what we believe all the unique qualities of this I jumped.
The most emerging therapies in development for negative symptoms well repair without these are most clinically advanced into phase three trial has been designed to test its efficacy as monotherapy versus placebo ups sends a couple Dick effects of Quad ministration, <unk> actually because I'm, 2% Cox.
Yeah I'm excited about the possibilities for wrote a parrot done as we plan to shares a topline results from the phase three trial that not too distant future.
You know turn it over to Jeff.
Thank you Remy.
Earlier. This morning, we issued a press release summarizing our operating results for the first quarter ended March 31st 2020.
A more detailed discussion of our results maybe found in our quarterly reports on form 10-Q filed with the FCC earlier today.
Cash cash equivalents restricted cash and marketable securities as of March 31st Twentytwenty were approximately $37.6 million compared to $46 million as of December Thirtyth as 2019.
We presently expect out the company's existing cash and cash equivalents will be sufficient to lead this anticipated capital requirements for at least the next 12 months from today.
Into mid late Twentytwenty wrong based on our current operating plan.
The assumptions upon which this estimate is based on routinely evaluate that it may be subject to change.
Research and development expenses were $8.1 billion into first quarter of twentytwenty compared to $11.6 million into third quarter at 29 team.
The decrease in R&D expenses, primarily reflects lower development expenses for the phase three clinical trial or Brody paradigm under phase to be clinical trial of mid long long seven.
R&D expenses are expected to decrease steering towards you're trying to with the completion of the phase Twob trial of Min 117.
And the 12 week double blind portion of the phase three clinical trial of role that paradigm.
General and administrative expenses were $4.2 million into first quarter of twentytwenty compared to $4.7 million into first quarter, a 29 threed.
This decrease in DNA expenses was primarily due to a decrease a noncash stock based compensation expenses and the decrease in professional fees.
Net loss was $12.2 million for the first quarter twentytwenty or a loss per share of 31 cents basic and diluted compared to a net loss of $15.8 million for the first quarter 2019, or a loss per share 41 cents basic and diluted.
Now I'd like to kind of the call ever to the operator for any questions operator.
Thank you.
The asked the question at this time you any depressed Star then one on your telephone to withdraw your question. Please press the pound key against that it started then why if he would like to asked the question.
Our first question pop on the line of Jason Butler with JMP Securities. Your line is now open.
Hi, Thanks for taking my.
Questions I.
Remy I think what's about this before but with the data.
Fast approaching just wondering if you could remind us of the Oh, the baseline characteristics you've seen in the phase three trial and applying to basis versus what you had in the phase two trial, and then give us an update and what you've seen again on a blind to basis in terms of positive symptom relapse. Thanks.
Hello, Jayson Hello, everybody. So so clearly I mean, oh he knows the what do you have you just phase to be was a negative symptoms of on the 25 points a baseline.
And Oh geez throws at them and we are monitoring of the she's a face we completely blinded by merging together.
Or is a patient you Anderson study and a after assays that we.
We are ending up is exactly the same entries core in terms of negative symptoms, which is obviously, a great yields and sometimes I couldn't even give you a little bit more granularity or having goes up I mean, what we see over the first a 12 week students a double blind phase in terms of shot so behavior and the dynamic of the negative score.
He is a really overlapping between.
The two studies the phase to be interface, we know concerning the.
Relapses.
No. So there was a gain of one point, which is a debate about what these every ups, but let me know what I can tell you is that comparing again.
No it seems to be phase three or so I'd love to lapses, we can see he's a limited and these are in line between the two studies.
Great and then just one more for me can can you just speak a little bit due to where you are in your commercial preparations and what your.
Goals are to achieve throughout this year as as you ramp towards a potential launch next year.
So maybe I couldn't give they said well that's a rig so yes, it's somewhat.
But the question sorry.
Yes, sure so hi, Jason Good morning, So a couple of things here. So first of all you may recall, we've already.
Side to commercial supply agreement with Catalent I'm. So, we'll obviously continue the work to be ready to have commercial supply available or watch. We've also received conditional approval from F.D.A. portray Dan we Havent released that yet we will sometime in the future once the data reads out positively.
We'll enter more kind of formal dialogue with potential co promote partners. There was a number of companies that already have established relationships with in psychiatry here in the U.S. market. So I think we're we're quite interested to reach out and talk to some of those folks and see if we can.
Essentially a wide with some of that jobs.
Existing infrastructure and do a co promote with someone like that.
Great. Thanks for taking questions and looking forward to the data.
Thank you Joe.
Thank you. Our next question comes on the line Joel Beatty with Citi. Your line is now open.
Hi, Thanks for taking the questions.
First one is on data integrity, you know there had been an issue. They came up around late last year. So I guess, you're just to confirm for the 362 patients that's completed a double blind study.
I have you have you ever view that you'll you'll have dead on all those patients.
Hi, John Yes, Oh, Hello tail it daily no impact on data integrity.
Blended one of the previous calls or.
No this mostly impacted the speed Likud recruits Creed, then and include patients in the study a randomized patients the study, but because we took all the person cautions firms are beginning to ask for example to I'd cards.
Lot samples on site.
One set of send it to two to to be analyzed essentially and one kept them side I mean, we really did not experience any and the impact correct about what happened.
A few months ago. So so clearly very clearly all these 360 patients can be fully analyzed.
And Oh, maybe a one what about Cobiz because I guess you see that's a very hot topic, which I know you've talked to probably does we as we mentioned the regularly over the past.
Terrific and I guess a question here given that there's two dosing arms could you remind us of the stats plan.
This is a great question.
Well first of all of you know one one interesting point is that the even if we do have requested we share that were a statistical analysis plan Liza was the F.D.A.S. and we received the feedback which.
Already confirmed as a way the we would like to analyze the data we will analyze the data because it's no becoming [laughter]. The reality is but that's as a statistical analysis plan is that ICICI reuse easy and then the red and approach and Oh, He's a corrected for type one that.
<unk>, we'd see Horsburgh correction, so basically what it means is that Oh the primary endpoints. Your first billings account the reason.
Between placebo and does the highest dose of 64 milligram, you feel heating or the P values are high person significant. So you can do the and obviously that's the second those that we just same.
5% W.P. and if not you have to divide by to.
As a P value for the second those and the basic thesis Mantech I mean, it's no longer PZ Replens youre fight, but it will be easier plans. There were 25 in order to claim that certainly took many grammys significant.
So this is the strategy, which by the way was the same we use the interface to be us because as you remember suffice to be has been normalized like a registrational study.
Got it yeah that makes sense.
One last question.
Sell trucks and.
It sounds like you've had discussions what I see on that program going ahead. If it does could you talk about how the cost would it be split for the not part of development.
I guess I gave this over to Jeff suggest can you can you answer this question. Please.
Sure Yeah.
The agreements very clear in terms of.
Each party's responsibilities with regard to funding.
The phase three part of the program back in 2016, we were required to amend the agreement that we have with.
With Yonathan as a result of a European Commission intervention in connection with the European in some of your market and the Actelion transaction, which J.R.J., we're seeking to get approval for.
That time, but basically the amendment to the agreement or.
Requires a minute but to cover the a full cost of the insomnia phase three program JNJ will give a 40 million dollar contribution to the phase three in some of your program and then on the other side on the a and B program.
We split the cost 40% of 60% JNJ.
Great. Thank you.
Welcome.
Thank you next question comes from the line of Baron Alan with Jefferies. Your line is now open.
Yeah, Hi, guys. Thanks for taking my questions. So Remy in the press release it seems that.
You have a 30% dropout rate is that how we should think about.
Ill patients that have completed trial versus enrolled.
And whether yeah, how does that number compared to what your assumptions or for the trial design and I guess, where there any imbalances across the three arms in terms of dropout rate.
[noise] Whos last question I cannot answer because just how these blinded.
But.
The first alumnus first of all I can answer this so the assumption. So if you remember where 40% dropout over the first 12 weeks another double blind phase and ER and we ended up we certainly person dropout, which if you remember it's really lined with what we had interface to be yes, basically so.
I think this is good deals, yes, because we have less lipids and what we had the number are hovering assumptions.
Okay, and then on the patients.
That completes the open label I think you have 92 patients I have completed the open label expansion can you tell us anything about these patients when they came into the open label versus one. They exited are you able to look at that data given its open label data and to see what the changes or better.
That's where in terms of negative symptoms are these patients.
Yeah short shorts about so just keep in mind doesn't mean or you know the patients who have been uncertainty two milligram or will stay on social media ground Lessor page 764 will stay on 64 and.
And if placebo patients are going into the open label job randomized to as one of the to those just so we don't know.
Today, what these are those the patients had yes, I mean, the but but who knows I have no placebo, but we don't know, but you do they have in terms of.
Got it paradigm, but yes, indeed, obviously we are following.
These patients as he knows its primary objective of these the extension is particular bucks or so.
100 patients exposed that to who's a drug for one year or so this is ladies as a safety aspect, but this is what you have to do a.
So it takes a bucks to go fuzzy angeliki.
We'll go to the FDA, especially I think this is ready extremely good use because we have still a lot of patients going on do you have already not to have completed. So I think we are really good shape for taking these books. So we obviously, calling just patients in terms of safety and efficacy.
And without having as much detail details as opposed to double blind phase I seem to have just things are.
Behaving in terms of efficacy like it was interface to be as well so.
So cost so that's on the very reassuring.
Okay, and then maybe a question on self correct that what are the key gating items, starting the phase three and do you anticipate.
Starting to pay three this year.
So.
Let's say, we recently had they set and tries to meeting these other colleagues from Johnson and Johnson.
And Andy Gupta several feedback. So this meeting was ever see really concentrating on focusing on on the on the mbd indication where I means a key question was up to know are you.
His patients who are responding batteries insomnia AWS a primary population.
So this is a signal really clarify.
What was also a point is crush Henry's aren't going more into the dates as was the how did you quantify.
In some yes.
Subjectively only subjectively or end objectivity and those have been clearly heights. So we as we speak this protocols have are adopted and finalized.
And as a feasibility is going on but as you know.
With that koby the armed to make a this is a bdcs are more complicated. So we are working on it and as soon as Youre ready, we will give you more details but there. So this is a.
What is currently ongoing but a little bit slower than expected due to the physical Greta pandemic.
Okay and then maybe just the last question what are your thoughts on R&D expenses once the phase three finishes.
As you know I have I have a lot of I guess, that's on the investing says the good news or ease at them in a if I mean, we have enough positive data was a veliparib done we haven't really a lot of things. We can you can do or insides is it's a frame indication. The as you know because then I guess.
So in terms of media.
This trend you have no stick.
Symptomatology your retrieve it not in several different these orders in the space Psychotria even urology.
We will obviously it or.
Work and our noses so as of today, we have a put together those are perfect world and there.
We end up because I think too. Many studies. So we are currently discussing internally taking whats advice from some of our kilowatt hours of what would be the priorities to two studies to do.
After topline results, so, let's take a little bit with us, we brainstorming, they're coming up with the best way.
Way moving forward that I mean, maybe lumber, we have two or three or.
The exciting studies, we have in mind, which I think will.
Before I cover or hybrid unmet medical needs and that would create a lot of body.
So this is or what you have in mind and and that beyond that really paradigm. I think we have going so a plan or place in order to move forward.
Obviously to work on Sept direction program, but also to move forward the.
As a multi towards you know pipeline, so I love to come or but again that.
Working procon progress.
But I think we have the lack of clarity no just priorities to to be made.
Great. Thank you.
Yes, most of what.
Thank you as a reminder to ask the question really need to press Star then one on your telephone.
Our next question comes on the line of mild winter with William Blair. Your line is now open.
Hi, guys.
Congrats and thanks for taking the questions just Remy last time, we talk just started for a month like guard.
You might mention that kind of a daunting not going to impact topline data potentially the.
Portion.
I'm wondering if you got any more clarity into the tosses delays, we may or may not expect there and if there are these the U.S. sought specifically or are these broad and across the entire Ah <unk> global nature of that trial I got a follow up after that thanks, Yeah, Yeah, Yeah, Myles so I.
I guess, what I said is at the moment, we have no impact on the extension the due to cobiz, but obviously I cannot predict what will happen moving forward, yes, but I.
As of end of last month side. The hyper we had no impact of Colby. This on the extension, so which is both user and ER and I think a really really put in place. So we have been extremely reacted and they have to say what that means the guidelines coming out from the FDA Hello Hello.
Have you had been extremely reactive or reis, our COO role and we just sites.
Two rady incremental order or what is a possible in order to come to use the exploration in terms of safety and.
And the efficacy for if I guess, the evaluation sorry for the patients or.
As you remember actually got you also discussed above the effect up we have in each country. We have enough said drug into countries. So so this will not have an impact too.
Who brings a direct to each patient there always seems extension them to each side, obviously, so so far so good Oh, we continue to monitor the a very interactive we obviously are using the guidance.
Sure possibilities given by the Bugs me Yeah, you gave guidelines about for example, remote monitoring just kind of things, but ER or Greg today, we have no impact to.
As we speak.
Sorry last point about the U.S., So last point about U.S., sorry, but this one.
Remember that I mean, the U.S. poppy before is that your insights and.
Clearly I mean, we have a rig a limited number of for a few aspirations, while Stephen can extension or so so I think.
We will not have the problem Uh huh.
In the U.S. because the extension as wasn't so so definitely I mean really up to the U.S. was a monkey.
Sorry, it would be satisfied that the non CKD patients that have complained about extension trial is a significant portion of them are invade U.S. patients.
It's a mixed it's a mixed but I mean clearly as the first one was completed.
12.
Monster, sorry, yes definitely.
Let me from the U.S. India.
Okay Cool and then just on Seltzer wrecks and I'm curious in the press release, you you mentioned youre chasing this it jumped to empty day indication consulted with insomnia.
But you didn't mention about the insomnia program alarm.
I'm wondering whether or not MD day is taking the priority here of it suggests implies a large part in that and then.
Obviously with MD day, Charles placebo responses, a crucial to the outcome studies Charles I'm wondering whether the placebo response rates in patients that it came over with insomnia defects adores without and whether thats for lighted July background medications like self today, Matt and things like that at these prices.
Tighten coming into that potential shop.
Yes.
Okay, great questions like go away. So so clearly clearly I think.
Or the towards the two indications.
Our positive Harbor Oliver.
Keith objectives to move forward, but I mean, Xie Xie Xie insomnia date, I mean in patients without any comorbidities, where soak here I mean this is a straightforward process I mean clearly.
Remember we had the.
Really a very nice data eat in others and didn't elderly and do our batches and then standards has opened that Miss and and does it tolerability profile was excellent. So so that here I mean.
It's a quite easy asphalt identical may not no no no really big surprise white was a little bit more tricky, obviously was easy MDD indication because it clearly.
When you have complained of insomnia.
And the end D are clearly it means a response is much better.
There's no doubt about it because it's just data driven.
There is no doubt there, but it doesn't mean the these patients are responding to better and then you're looking to the possesses a teaser rate of respond to.
The delta between between treatment and placebo I mean, just becomes media very very significant them very very meaningful yes, I do want to say clinically meaningful because I.
I am most this is clinically meaningful that at minimum just patients are doing much much better is when spent to having some the NMD d.
So this is a this is the reason why it took a little bit longer to think about what was just maybe in terms of.
Let's see but response I have no no definitive answer to your question because I think we did not best of my knowledge, maybe my colleagues in R&D did it and we'll be happy to report if you have maybe it has been done the later.
But I don't have that notion of having a different placebo response as you know placebo response is how you select the patients on how your run your trial.
But but I have no no no good knowledge about the is already things, but well just clear is that the when you're looking again to the difference we have seen between the treatment and placebo eaves that patients having somebody in addition to their MDD disorder.
You know as there is no doubts if any of the read rocky such here. So so I'm very confident that said moving forward.
We will not really struggle reserve placebo.
Effect, what what's the what is important I think two dimensional this is a much more generally commons and.
Which is going be onsite directionally is that distinguish the current ongoing academic I think as the patient suffering from MDD have probably not just same phenotype.
And then what we have seen before as upon the Nick and I think we have to single, it's hard to but what would happen after that pandemic guess because as you know people are losing a joke people are more stressed people are more anxious to people. So I think because this is something we have to reconsider but when we are running again the depression trial. So but does this is a.
Maybe another debate the more generally debate, but I think we are really consider exists.
Because I think it becomes important and maybe maybe this is just expectation.
In summary, our mutual will be even more important here after considering.
That's fair thanks for the questions.
Welcome.
Thank you. Our next question comes from the line Douglas Tsao with H.C. Wainwright. Your line is now open.
Hi, good morning, Thanks for taking the questions just quickly in terms of how long do you think or.
Once you get the 100 patients for the team imminent and the extension how quickly can would you be in position to file the NDA for roll a paradigm and just given the timing of the readout for phase three thank you.
They'll get.
This as you know I mean, it's not the ethical to stop any patient if he stays in desist does a trial until the end till the end of the 12 months or so so basically.
As the I mean, some of this last patients are completed to double that changed anything does extension. So so it's as these patients are staying in the into 12 or so nine months holdings as other banks Faiza. You know two teams of Bucks of 12 months I mean, they will go through the end and.
And so as I said Gee extension data that will be get the how many we will get probably will get much more than the 100 renewed it we need to fix the bucks about safety as extension has to be completed so this will happen.
You know beginning of next year as into first quarter assumptions. So so clearly we cannot transition, but so what we will do as you know and this is not becoming more and more common does that yet gay is really very open.
So that's just kind of pre pre NDA meeting this and we xchanging on a regular based busy with the FDA and.
When we have the topline results. We will obviously shares this was yesterday discuss it was yesterday and.
My colleague adjusts our the charge if R&D. It has a has really worked a lot than we have a lot different outputs. In addition to that.
Primary and secondary endpoints in order to really understand fully understands the data. So we will we will digest all this hopefully based on positive data and you'll start to work as you have good but again, we need to go to the end of the extension to have a complete packages for the end game.
Okay, great. Thank you.
Welcome.
Thank you.
This concludes today's question and answer session I would now like to time it all back around wheelabrator for closing remark.
Yes. Thanks, so much so thank you everybody for.
Listening to each other our earnings call.
It is obviously a very important moment for the company. We are very close notes was the result of a lot of work a lot of hope for patients and hold pretty lots of fair value creation car.
For our shareholders. So I just want Brady looking forward to update you very very soon about our phase three results. Thank you all have a very nice day.
Ladies and gentlemen. This concludes today's presentation. Thank you once again for your participation you may now disconnect have a great day.