Q2 2021 Minerva Neurosciences Inc Earnings Call
[music].
Welcome to the Minerva Neurosciences second quarter 2021 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 the nervous website at IR that Minerva Neurosciences dotcom.
As a reminder, today's call is being recorded on.
Now I'd like to turn the call over the William Boni, Vice President of Investor Relations Communications at Minerva. Please proceed.
Good morning, a press release with the company's second quarter 2021 financial results and business update.
Became available at 730, a M. 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 SEC's website at Www Dot SEC Dot Gov.
Joining me on the call today for of Minerva are Dr. Remy loops, Ringer executive Chairman and Chief Executive Officer, and Mr. Geoff race, Executive Vice President Chief Financial Officer, and Chief Business Officer.
Following our prepared remarks, we will open the call for Q&A.
Before we begin I would like to remind you that today's discussion will include statements about the company's future expectations plans on prospects the.
Constitute forward looking statements for purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of $19.95.
We caution of these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated.
These forward looking statements are based on our current expectations of may differ materially from actual results due.
2 of variety of factors sort of more fully detailed under the caption risk factors and on <unk>.
Fillings with the SEC, including our quarterly report on form 10-Q for the quarter ended June 32021 filed with the SEC earlier today.
Any forward looking statements made on this call speak only as of today's date Monday August <unk> 2021 on the company disclaims any obligation to update any of these forward looking statements to reflect the events or circumstances that occur after todays call.
As required by law.
I would now like to turn the call over to Remy Luther Inger.
Thank you Bill and good morning, everyone. Thanks for joining us today.
Following the completion of the open label portion of the Phase III trial of this royalty of paradigm in schizophrenia, and the type C meeting with the FDA Minerva continues to work towards the submission of a new drug application in the first half of 2022.
Towards the end, we have completed enrollment in the pivotal bioequivalence study we enrolled the paradigm in healthy volunteers. We also continued to make progress on assembling the components required to submit the NDA for royalty per day, including clinical pharmacology, non clinical and CMC activities.
We anticipate completing these activities over the coming months and we look forward to continuing our dialogue with the FDA and anticipation of submitting the request for a pre NDA meeting.
Let me begin with the volume kill on study.
On April 22021, we initiated subject screening in the study conducted in healthy volunteers.
So objective of the study is to compare the formulations of employee interface to be in phase III trials as well.
At least 1 new formulation designed in conjunction with our commercial supplier to facilitate large scale manufacturing.
We are seeking to demonstrate similar drug exposure between the formulations.
On June 29, 2021, we completed the enrollment of 48 subjects in this study.
We look forward to reporting the top line results, which are expected in the third quarter of 2021.
In parallel with completing the bio equivalent study we are working on additional activities required to support an NDA submission for all of the paradigm.
These activities are informed by our interactions with the U S. FDA since the type C meeting last November.
So rationale for NDA submission was strengthened by the findings from the open label extension.
In summary, the findings of our supportive in several key areas.
First it demonstrated the specific and continuous improvement in negative symptoms among patients who received monotherapy is really paradigm throughout the duration of the 9 months of open label extension period.
The measured by the amount of negative symptom practice color.
Second this improvement was correlated with functional improvement as measured by the personal and social performance.
Sir so absurd relapse rate of approximately 12% compares favorably with relapse rate of more than 25% to search the personal savings of schizophrenia the literature.
Finally, the extension data showed that for other Paragon was well tolerated with low weight gain extra payment of symptoms protecting increase or sedation.
In summary believes that the completion of the bio equivalent study will represent an important component of the NDA package.
We are encouraged by our ongoing interaction with the urgency and we believe we have addressed nearly all of the issues right at the other types of meeting last November.
We are also making excellent progress towards the completion of the NDA.
Following a successful bio equivalent study we plan to request a pre NDA meeting with the FDA to discuss the <unk>.
NDA content and readiness for submission.
I will now turn it over to Jeff for the financial update.
Thank you Remy.
Earlier. This morning, we issued a press release summarizing our operating results for the second quarter ended June 30 of 2021.
For more detailed discussion of our results may be found in our quarterly report on form 10-Q filed with the SEC earlier today.
Cash cash equivalents restricted cash and marketable securities as of June 32021 were approximately $74.3 million.
Compared to $25.5 million as of December 31, 2020.
Our cash position was strengthened significantly in January 2021, with the receipt of of $60 million.
Cash upfront payment from royalty pharma in connection with royalty pharma acquisition of the company's royalty interest and south direction.
Under this agreement Minerva has the potential to receive up to a third of the $95 million in additional payments contingent on the achievement of certain clinical regulatory and commercialization milestones.
We expect that the company the existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for it.
The next 12 months based on our current operating plan.
On the assumptions upon which this estimate is based are routinely evaluated and may be subject to change.
For the 3 months ended June 32021 on 2020 research and development expenses was $5.5 million on $5.8 million, respectively, a decrease of approximately $3 million.
For the 3 months ended June 32021 on 2020 noncash stock compensation expense included in R&D expenses was <unk> $6 million and north of $7 million respectively.
For the 6 months ended June 32021, and 2020, R&D expense was $8.8 million and $13.8 million, respectively. The decrease of approximately $5 million.
For the 6 months ended June 32021 on 2020 noncash stock compensation expense included in R&D was $1.3 million on $1.4 million respectively.
The decrease in R&D expenses for both the 3 on 6 month period ended June 32021 versus the same periods. In 2020 were primarily due to lower costs for the phase III clinical trial of role of paradigm for which the 3 months of course 30 portion of the trial.
With completed in May of 2020.
For the 3 months ended June 32021, and 2020 general and administrative expenses were $3.4 million and $5.9 million respectively.
The decrease of approximately $2.5 million.
For the 3 months ended June 32021 and 2020.
Noncash stock compensation expense included in G&A was north of $7 million on $2.8 million respectively.
For the 6 months ended June 32021, and 2020, G&A expense was $7.7 million on $10.1 million, respectively. A decrease of approximately $2.4 billion.
For the 6 months ended June 32021, and 2020 noncash stock compensation expense included in G&A was $1.6 million on for $3 million respectively.
The decrease in G&A expense for both the 3 and 6 month periods ended June 32021 was primarily due to a decrease in noncash stock based compensation stock based compensation charges were higher in 2020, primarily due to the approval of <unk>.
Certain stock option grants on certain severance related benefits.
Okay.
Net loss was $10.6 million for the second quarter of 2021 for net loss per share of 25 basic and diluted.
Compared to net income of $29.5 million for net income per share of <unk> 75 basic.
Basic and <unk> 73 diluted for the second quarter of 2020.
Net loss was $19.4 million for the first 6 months of 2021 for net loss per share of 45 cents per basic and diluted as compared to net income of $17.4 million for net income per share of 44 basic.
And 43 diluted for the first 6 months of 2020.
Okay.
The decreases in net income for both the 3 and 6 month periods ended June 32021 were primarily due to the company's opting out of the joint development agreement with Janssen Pharmaceuticals for the sell direct from the program during the second quarter of 2020.
As a result of opting out of the agreement the company immediately recognized $41.2 million and collaborative revenue.
You had previously been included on the balance sheet under the deferred revenue.
Net loss during the 3 on 6 month periods ended June 32021 included noncash interest expense of $1.6 million on $2.9 million, respectively versus zero expense for both periods during 2020 the.
Non cash interest is incurred in connection with the liability related to the sale of the future royalty to royalty pharma in January of this.
Yeah, which is included on the company's balance sheet.
Now I'd like to turn the call over to the operator for any questions.
Later.
Thank you to ask the question you will need the press star 1 on your telephone to withdraw your question press the pound key.
How long are we compile the Q&A roster.
Our first question comes from Andrew Tsai with Jefferies. Your line is open.
Okay, great. Good morning, and thanks for having the first question is on just the open label extension.
Had the impression you have.
Interacted with the FDA from time to time over the course of 2021 of.
And you.
You've addressed with some of the some of them some of the things that come up that came up during the type C meeting so if that's true I.
I guess how have those discussions progressed have you discussed the open label extension data with the FDA, yet or should we expect that to happen later on in the queue for pre any pre NDA meeting.
Hello, Remy speaking of so so that's the thing that we have not.
As close of the open label extension data with the FDA.
The interaction we have on a regular basis since the beginning of the year or a bunch of topics, which have been the raised during the type C meetings. So for.
The open label.
The extension data of UMC.
Of the published presented on the.
We definitely will obviously put this part of.
All of our package or a briefing book to be submitted to the EBITDA for the pre NDA meeting that so.
And I guess I guess, it's an important piece of information.
If you keep in mind the results of the obtained.
Great.
And as a follow up for the Bioequivalence study can you just give us a little debt more clarity around the design of the study I know of 48 patients enrolled.
It sounds like Youre evaluating 3 different formulations.
Yes.
Many different doses, what exactly do we want to see in the top line data basically thanks.
This is of great question.
Basically basically first of all of them in the.
The protocol has been the share.
And as.
As I think I say gave the last earnings call. We did not stop the study before having the feedback from <unk> from the FDA and we got we got the.
Feedback from the FDA.
The reason, obviously I mean, we could stop the study so so basically I mean, if you remember getting the.
On the type C meeting all of the.
<unk> EBITDA was questioning.
About differences in terms of formulation between the face to be in phase III.
So the main objective here is of today amongst trades in the sense of face to be formulation has the same exposure or equivalent the exposure towards the phase III formulation, which has been used just to refresh the mind of everybody. What we deal mostly because of the formulation of the face to be end of phase III.
<unk>.
No major change the only thing we did was to really Inc.
True.
So as of tablets by put things on gas to resistant in order to minimize.
For the effect, because we had the food effect of positive through the effect in the phase 2 b formulation and that's the reason why you had to give them the.
Tablets.
Distance from food and so the.
We definitely were successful in to the minimizes the food effect.
And with.
With the existing <unk> discuss the resistance. So this is the ease with what people would be the said I mean, the gains of main objective is to the show bioequivalence in terms of exposure of the compounds that we have included the.
Third.
I'll, just say tablet, which is the.
The commercial tablet because of it.
On a provider because we are already working on lot of scale up and to be ready it looks the at least this level now.
After obviously of having a positive outcome with the EBITDA.
Here I mean, some ingredients had to be changed so nothing has changed in terms of activity.
The active ingredients are it is only 2.2 per se.
Realizes the topics. So so against free formulations of 48 subjects why 48 tenths of subjects because it's considered the doesn't pilot study so you'd need the primary accordingly for that the reason why didn't you just number of of.
Of the subjects up to the power of 90 person than the.
Basically the subject of ours that on controls.
So the <unk> <unk>.
Patients can be comparable.
We also have added obviously arms with the.
Wasteful that without food in order to the Reconfirms, The fact that I mean.
We are controlling for a positive for the fact, which you had in place to be which we do not have of Liza phase III tablet formulation. So.
A quite large study.
Power to be conscious of the best of price per stop you have to find the answer about the bioequivalence between sort of tablets and also the answer about the for this.
Great. Thanks, Thanks, very much very helpful.
Very welcome.
Our next question comes from Myles Minter with William Blair. Your line is open.
Hi, Thanks for taking the questions.
I just wanted to guard back to the <unk> analysis of the phase 3 trial on an already that with price specified in the statistical analysis plan on.
I'm wondering whether you could tell me at what point of the statistical hierarchy that analysis on the primary endpoint in the <unk> population actually sat on a way of disclosed nominal P value is here and I understand the has to be nominal but.
Im trying to understand the potential degree of multiplicity.
Part of that so I just wanted to know where it sat in that original sac.
If you could provide any color on that that'd be great.
Yeah. So obviously.
Like all the way.
Barry.
For the important question, that's 1 of them happy that you answered the suppliers to be able to clarify so basically both of the same 11 and that's because of how they explained already when we picked up during the blinded review of it on before openings of blind the.
Of the study.
We picked up the size of this 17 patients for 107 patients.
When we submitted the final on statistical analysis plan.
Proposed to the EBITDA, you'll be putting it in the document the obviously.
Does that mean, we will analyze the data.
The ITT data NZ M ITT data and you put them at the same on the same level of aspect the.
Obviously, we can only speak here about the nominal P value for the moment because it is not the primary endpoint disclose the ITT.
As you have seen from the minutes of the type C meeting.
It's always the months of our for you as an OEM diesel was tightening of it is as much of a preview because they have to go the pieces of data.
The acceptance of funded debt I mean, the <unk>.
<unk> will be conscious of it and we should submit that were filed with the ITT.
So this is how the events of the interactions with the MTA Wednesday. So so again I mean, it's of much of a review but the.
<unk> clearly and the defied the is clearly recognized by the urgency on.
On the home from there we will see us of what the split is next but I mean, so I'm very confident because we know as we just test actually goes of already before the.
Quite a lot of the precedents, where I mean, if you have really a very good rationale the very good reason why you should exclude some subjects.
You can go with the M ITT and the and so it just stays even of CNS. So we are definitely feeds the topic here, where <unk> is some seem to be comfortable.
Okay Fair.
Fair enough and then on the Bioequivalence study.
Obviously, the protocols bans on body run past the agency and that they are aligned with it.
Yeah.
I'm curious as to whether you've had conversations with them debt about that comfort level with the commercial formulation from Cadillac debt.
You will likely not have clinical and safety.
Data outside of the healthy volunteers.
Prior to submitting for MDI light of day happy with the fact that the face.
The survey in the phase 3 formulation you have clinical data around that.
Maybe you of White house that for the commercial formulation, there's no chance of Nike.
19 of you'd like to try and run on additional Saudi of something yet.
I see.
I think clearly not just because I mean, we clearly.
I've described.
The other differences.
Between the commercial of the phase III formulation.
The protocol.
We have obviously or the the solution data or what you need in terms of CMC.
2 the filters are for Europe for you at the end of the agenda of the CMC package for the NDA. So I think a long tail.
I mean, there will be no surprise at this level because it means that of the modifications on really minor it's purely technical.
Technical and it does not change of the room.
The type of.
The active ingredient of the Arctic parcels of cabinets, but have you had been pretty clear in the into protocols on how.
I do not foresee any any problems there.
There are beautiful Ah congrats on the on the art, Michael died or as well on the.
The progress I'll jump back in the queue. Thanks.
Thank you so much Mike.
Thank you and as a reminder, if you wish to ask the question at this time. Please press Star then 1 of our next question comes from Jason Butler with JMP Securities. Your line is open.
Hi, Thanks for taking the question I'm just wondering obviously now you have the law of data what are your plans to continue to build awareness of the data and the.
On the drug over the next year or so as you progress through regulatory submissions.
Obviously presentation of the data at medical meetings, but beyond that any.
Plans to bring on board MSL or or even the non branded awareness campaign or and then secondly, do you have any plans for an expanded access program either here in the U S for Europe. Thanks.
Great question Jason.
So obviously, yes, we.
We'll pause on debt the medical meetings of the I think of there are some presentation at the <unk> College of Neuropsychopharmacology on and we will also be president of the American College of Neuropsychopharmacology end of the year. So definitely yes, we will disseminate them. These data.
As we speak for the last.
The weeks when we got the data we have also this growth quite extensively with the.
Some of our kind of Kols Simona involved in advising us, but I mean, the who and much larger.
In order to have 1 of the state of becoming aware of 2 of our relaunch of <unk>.
Part of the of the.
And if he can medical community.
For the for your more couples of broader approach I mean, we might we might think about the.
A webcast.
But we have not decided yet which will really give it.
Gain of complete update about the.
Our development on our package because I think it is important so what that means is put into the context then on destiny.
We will also give updates.
Obviously, a bunch of bioequivalence study, we will give updates about the pharmacology because I think the.
The pharmacology of the drug is oh containing a very hot topics like the Sigma Sigma targets for that.
Because the out of the targets for all of this we will do it but the between today and the and didn't know what the hedge.
The NDA submitted the I think we're going to really stay focused on R&D on preparing for the best trial.
And I guess just on the off towards the new lifestyle for tier we will focus on the on.
On the different topics you mentioned.
Great. Thanks.
Thanks for taking the question.
Thank you. Our next question comes from Douglas Tsao with H C. Wainwright Your line is open.
Douglas Tsao of your line of something please check your mute button.
Hello.
Can you hear me.
No I hear you Doug.
Yes, sorry about that.
Joe just given all the activity that you have going on but obviously you have a lot more freedom now with the royalty pharma.
Financing on them.
Curious.
Given the breadth of opportunities how are you thinking about.
Proceeding with other trials for roll of the paradox of somebody earlier indications or settings that we've talked about.
Obviously, you're prioritizing the NDA submission, but I'm just curious.
How you're thinking about that and when we might see some of that other clinical work start.
Obviously I mean the.
This is on is in parallel we are.
Really contribute to brainstorm.
First of all the continue to sort.
To get the maximum out of all of the data. So I'll give you. An example of we are currently working on the.
How much of the.
The improvement of negative symptoms is linked to the to the function of improvements in the for Matt.
The excellent with PSP total score we are also focusing on the sub scores of Oh PSP.
Remember we had the signal in terms of coordination we also work to transition the.
And with internally on the resolve of our Kols we are definitely.
Working on the what would be next.
Hopefully post approval in.
In terms of on.
Studies version of it terms of.
The studies, which they put the.
The carryout inside the echo ecosystem for schizophrenia, and definitely also trumps getting the uptick so I guess the the right answer for your question is the as such we.
Anticipating of also having a good understanding of the kidney besides the understanding of what is the right. The CLO to use if you are running a study sales is 1 of activity because of.
This is important to have the.
On the right setup here, but maybe we are also putting together on.
The plan.
No. The 2 in terms of the clinical trials and the expanding the indications and.
I'm quite sure sort of I mean, this is the point, we will discuss them on behalf.
In the in the second half of these chosen as a pre NDA meeting with the FDA, So making sure that we all have all the different the.
Options of opening order 2 to run trials in.
It's the best conditions, who has the best sites is the best organization and I think slowly, but surely we have Noah Larry.
The effective and efficient kind of in place in terms of clinical trials, which we can the also discuss the committed with the FDA. So we already but the for the moment for.
And at the center of.
A very good meeting of very good the final discussion with FDA before we can start seeing any clinical trial.
We are working on it.
Okay, great. Thank you so much.
Thank you and I'm kind of for no further questions at this time I'd like to turn the call back over any of those ringer for closing remarks.
Yes. Thank you so much the.
A great day. Thank you for for the great questions and for everybody who participated disease cohort of.
Obviously, it's a very important.
The time for Minerva on this.
The bioequivalence study.
The oats, we'd be very important because it was 1 of the.
<unk> raised by the FDA during the the type C meeting so I'm really looking forward to update you very soon on all of this on the rest of the progress we're making because we are also working on the dump. This because it's such a day, but you are working on all of the preclinical package.
Putting all of this endeavor.
NDA package, so lots going on on I'm looking forward to updating of Airbus. Thank you for all for participating.
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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[music].
Welcome to the Minerva Neurosciences second quarter of 2021 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 the nervous website at IR Dot Minerva Neurosciences Dot com.
As a reminder, today's call is being recorded on.
Now I'll turn the call over the William Boni, Vice President of Investor Relations Communications at Minerva. Please proceed.
Good morning, our press release for the company's second quarter 2021 financial results and business update became available at 730, a M eastern time.
Good day 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 SEC's website at Www Dot FCC Dot Gov.
Joining me on the call today for Minerva are Dr. Remy <unk> executive Chairman and Chief Executive Officer, and Mr. Geoff race, Executive Vice President Chief Financial Officer, and Chief Business Officer.
Following our prepared remarks, we will open the call for Q&A.
Before we begin I would like to remind you that today's discussion will include statements about the company's each of our expectations plans on prospects.
The constitute forward looking statements for purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
We caution of these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated the.
These forward looking statements of based on our current expectations on may differ materially from actual results due to a variety of factors that are more fully detailed under the caption risk factors in our filings with the SEC, including our quarterly report on form 10-Q for the quarter.
<unk> ended June 30th 2 Clos 1 in 'twenty, 1 filed with the SEC earlier today.
Any forward looking statements made on this call speak only as of today's date Monday all of the second 2 calls on in 'twenty..1 on the company disclaims any obligation to update any of these forward looking statements to reflect the events or circumstances that occur after today's call except.
As required by law.
I would now like to turn the call over to Remy Lutheran care.
Thank you Bill and good morning, everyone. Thanks for joining us today.
Following the completion of the open label portion of the Phase III trial of its probably per redone in schizophrenia, and the type C meeting with the FDA Minerva continues to work towards the submission of the new.
The drug application in the first half of 2022.
So what debt we have completed enrollment in the pivotal bioequivalence study Israeli paradigm in healthy volunteers.
We also continued to make progress on assembling the components required to submit the NDA for royalty per day, including clinical pharmacology, non clinical and CMC activities.
We anticipate completing these activities over the coming months and we look forward to continuing our dialogue with the EBITDA in anticipation of submitting a request for a pre NDA meeting.
Let me begin with the volume came on study.
On April 22021, the initiated subject screening in the study conducted in healthy volunteers.
The objective of the study used to compare with formulations of employees in the face to be in phase III trials as well as it can.
Least 1 new formulation designed in conjunction with our commercial supplier to facilitate large scale manufacturing.
We are seeking to demonstrate similar of drug exposure between the formulations.
On June 29, 2021, we completed the enrollment of 48 subjects in the study.
We look forward to reporting the top line results, which are expected in the third quarter of 2021.
In parallel with completing the bio equivalent study we are working on additional activities required to support an NDA submission for all of the paradigm.
These activities are informed by our interactions with the U S. FDA seems the type C meeting last November.
So rationale for NDA submission was strengthened by the findings from the open label extension.
In summary, the findings of our supportive in several key areas for.
First the demonstrated the specific on continuous improvement in negative symptoms among patients who received mono therapy is really the paradox throughout the duration of the 9 months open label extension period as measured by the amount of the negative symptom taxis car.
Second this improvement was correlated with functional improvement of Mezz.
Is it by the personnel on social performance can.
Sir the observed relapse rate approximately 12% compares favorably with relapse rate of more than 25 to search the person's ceilings of schizophrenia the literature.
Finally, the extension data showed us that relative Paragon was well tolerated with low weight gain except for.
The margin symptoms collecting increase or sedation.
In summary, we believe that the completion of the bio equivalent study will represent an important component of the NDA package.
We are encouraged by our ongoing interaction with the urgency and we believe we have on dress nearly all of the issues right and the other types of the meeting last November.
We are also making excellent progress towards the completion of the NDA.
Following a successful bio equivalent study we plan to request the pre NDA meeting with the FDA to discuss the <unk>.
The content and readiness for submission.
I will now turn it over to Jeff for the financial update.
Thank you Remy.
Earlier. This morning, we issued a press release summarizing our operating results for the second quarter ended June 30 of 2021.
A more detailed discussion of our results may be found in our quarterly report on form 10-Q filed with the SEC earlier today.
Cash cash equivalents restricted cash and marketable securities as of.
June 32021 were approximately $74.3 million compared to $25.5 million as of December 31, 2020.
Our cash position was strengthened significantly in January of 'twenty, 'twenty, 1 with the receipt of of $60 million.
Cash upfront payment from royalty pharma in connection with royalty pharma acquisition of the company's royalty interest and south correction.
Under this agreement Minerva has the potential to receive up to a third of the $95 million in additional payments contingent on the achievement of certain clinical regulatory and commercialization milestones.
We expect that the company's existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months based on our current operating plan.
The assumptions upon which this estimate is based are routinely evaluated and may be subject to change.
For the 3 months ended June 32021 on 'twenty 'twenty research and development. The expense was $5.5 million and $5.8 million, respectively, a decrease of approximately $3 million.
For the 3 months ended June 32021 on 2020 noncash stock compensation expense included in R&D expenses was no point $6 million on no point $7 million respectively.
For the 6 months ended June 32021, and 2020, R&D expense was $8.8 million and $13.8 million respectively.
The decrease of approximately $5 million.
For the 6 months ended June 32021, and 2020 noncash stock compensation expense included in R&D was $1.3 million on $1.4 million respectively.
The decrease in R&D expenses for both the 3 on 6 month period.
The June 32021 versus the same periods in 2020 were primarily due to lower costs for the phase III clinical trial of role of the paradigm.
For which the 3 months of course study portion of the trial was completed in May of 2020.
For the 3 months ended June 32021, and 2020 general and administrative expenses were $3.4 million and $5.9 million respectively at the.
Increase of approximately $2.5 million for.
The 3 months ended June 32021, and 2020 noncash stock compensation expense included in G&A was north of $7 million on $2.8 million respectively.
For the 6 months ended June 32021 on 2020, G&A expense was $7.7 million on $10.1 million, respectively. A decrease of approximately $2.4 million.
For the 6 months ended June 32021 on 2020.
Noncash stock compensation expense included in G&A was $1.6 million on for $3 million respectively.
The decrease in G&A expense for both the 3 on 6 month period ended June 32021 was primarily due to a decrease in noncash stock based compensation stock based compensation charges were higher in 2020, primarily due to the approval of <unk>.
Stock option grants on certain severance related benefits.
Yeah.
Net loss was $10.6 million because of the second quarter of 2021.
Our net loss per share of 25 cents per basic and diluted.
Compared to net income of $29.5 million on net income per share of <unk> 75.
Basic and 73 diluted for the second quarter of 2020.
Net loss was $19.4 million for the first 6 months of 2021 on net loss per share of 45 basic and diluted.
This compared to net income of <unk>.
$17.4 million for net income per share of 40 for basic and 43 diluted for the first 6 months of 2020.
Okay.
The decreases the net income for both the 3 on 6 month periods ended June 32021 was primarily due to the company's other thing out of the joint development agreement with Janssen Pharmaceuticals for the self directed program during the second quarter of 2020.
As a result of opting out of the agreement the company immediately recognized $41.2 million and collaborative revenue, which had previously been included on the balance sheet on the deferred revenue.
Yeah.
Net loss during the 3 on 6 month periods ended June 32021 included noncash interest expense of $1.6 million on $2.9 million, respectively versus zero expense for both periods during 2020.
The non cash interest is incurred in connection with the liability.
Related to the sale of future royalties to royalty pharma in January of this year, which is included on the company's balance sheet.
Now I'd like to turn the call over to the operator for any questions operator.
Thank you to ask the question you will need the press star 1 on your telephone.
Withdraw your question press the pound key.
How long are we compile the Q&A roster.
Our first question comes from Andrew Tsai with Jefferies. Your line is open.
Okay, great. Good morning, and thanks for having the first question is on just the open label extension I mean, I I've had the impression.
You've interacted with the FDA from time to time over the course of 2021.
You've addressed with some of the some of them some of the things that come up that came up during the type C meeting so if that is true.
I guess how have those discussions progressed have you discussed the open label extension data.
With the FDA, yet or should we expect that to happen later on in the queue for pre any pre NDA meeting.
Yes, Hello, Raymond speak English.
So that's the thing that we have not the.
This plus the open label extension data with the FDA.
The interaction we have on a regular basis since the beginning of the year are of odds of topics for shopping the range during the type C meetings for the.
The moment the open label extension data on yet.
He has been published presented on the.
We definitely will obviously put this part of all of our package or of a briefing book, we should make it to the EBITDA for the pre NDA meeting us.
And I guess I guess, it's an important piece of information.
You should keep in mind the results of the obtained.
Great.
And then as a follow up for the Bioequivalence study.
Can you just give us a little on debt more clarity around the design of the study I know of 48 patients enrolled.
It sounds like Youre evaluating 3 different formulations.
I guess, how many different doses what exactly do we want to see in the top line data.
Thanks.
This is the great question.
Basically basically first of all I mean the.
The.
The protocol has been the share FDA and the.
Although I think I said during the last earnings call. We did notice published target before having the feedback from our from the FDA and we got we got the.
Feedback from the FDA.
Obviously, I mean, we could stop the study so.
So basically I mean, if you remember again.
<unk> maintained all of the.
EBITDA was questioning.
About differences in terms of formulation, which was the face to be in phase III. So some of the main objective here is of today amongst trades in the sense of face to be formulation.
The same exposure or equivalent the exposure to the phase III formulation, which has been used just to refresh the mind of everybody. What we did mostly between the formulation of the face to be end of phase III formulation.
Major channel is the only thing we did was to really.
Improve.
The tablets by putting certain guests the resistant in order to minimize.
For the effect, because we had the food effect of positive food effect in the phase II B formulation and that's the reason why you had to give us on the tablets.
A distance from food and so the.
We definitely were successful in to the Minimises the food effect.
And by putting the stuff Thats got the released consoles. So this is the.
What would be the against the main objective is to to show bioequivalence in terms of exposure on the comp.
No we have included the.
Yeah.
Baird.
I'll, just say tablet, which is the commercial.
Tablets, because a number of provider because you're already working a lot of scale up and to be ready it looks for at least this landing zone.
After obviously of having a positive outcome with the EBITDA.
I mean, some ingredient has to be changed so nothing has changed in terms of.
Active ingredients are on.
The need to 2.
The industry realizes the top of it so so against free formulations of 48 subjects why 48 tenths of subjects because it's considered the pilot the study so you'd need the primary okay.
Accordingly for that day.
No I don't need the number of of the.
Of the subjects that would be part of 90 person on the basically.
Basically the subject of all of their own control.
And so the 3 conditions can be comparable.
We also have added on the fleet arms with the.
Wait for them without food in order to the Reconfirms the does that mean the.
We are controlling for a positive flow.
For the fact, which you had in place to be which we do not have a with the phase III tablet formulation. So.
A quite large study.
However to be conscious of the does the price per study on the final answer about the bioequivalence to the kinds of tablets and also of the I'm sorry about the food issue.
Great. Thanks, Thanks, very much very helpful.
You're very welcome.
Our next question comes from Myles Minter with William Blair. Your line is open.
Hi, Thanks for taking the questions.
I just wanted to guard back to the M. I take pay analysis, if the phase 3 trial on an already.
That was price specified in the statistical analysis plan on 1.
Wondering whether you could tell me at what point of the statistical hierarchy of that analysis on the primary endpoint in the <unk> population actually sat on a way of disclosed nominal P value is here and I understand the has to be nominal but.
Im trying to understand the potential degree of multiplicity to apply to that so I just wanted to know where it sat in that of original Sac.
If you could provide any color on that that'd be great.
Yes, so Microsoft.
Mike.
Well the very [laughter].
For the important question is I'm happy that you answered the supplier to be able to clarify so basically it both on the same level because of how they explained already when we picked up during the blinded review of it on before openings of blind.
On the study.
We picked up at the site of resist 17 patients for 107 patients and when we submitted the final statistical analysis plan.
The proposed for the NDA of we put in the document obviously.
I mean, the we'll analyze the data.
ITT data NZ Mitb data and.
He puts them at the same on the same level of aspect.
Obviously, we can only speak here about the nominal P value for the moment because it is not the primary endpoint disclose the ICT.
But as you have seen from the minutes of.
The type C meeting and it's all of the much of our for you other than the OEM days of West 10 annuities in the months of a preview because they have to go deep pieces of data.
The acceptance of some of that I mean the.
<unk> will be conscious of it and we should submit the file with ICT M ITT.
So this is how the events of the.
The interactions with the MTA, 1 so sorry, Dave I mean, it's a much of a review but the.
<unk> clearly defined.
Clearly recognized by the agency.
The home from that we will see us of what the split is next but I mean, so I'm very confident because we know as we just test actually goes to the already before the <unk>.
Quite a lot of precedents, where I mean, the if you have really of a very good rationale. The very good reason why you should exclude some subjects.
Can go visit him ITT and the ease of space, even though of CNS. So we are definitely seeing the topic here, where <unk> is the assumption can be comfortable.
Okay.
Fair enough and then on the Bioequivalence study.
Obviously, the protocols bans on body run past the agency and that they are aligned with it.
<unk>.
I'm curious as to whether you've had conversations with them debt about that comfort level with the commercial formulation from Cadillac the.
You will likely not have clinical and safety.
Data outside of the healthy volunteers.
The prior to submitting for MDI, a lot of day happy with the fact that the site.
So you pay in the phase 3 formulation you have clinical data around that.
Maybe you of White house that for the commercial formulation. The there's no chance of Nike you'd like to try and run on additional Saudi of something yet.
I think clearly not just because I mean, we clearly are.
I've described the world.
The differentiator.
The commercial loans of phase III formulation.
Of our protocol, we have obviously all of the dissolution day at all what you need in terms of CMC.
2.2 features of the PDR appeal at the end of the agenda of the CMC package for the NDA. So I think.
Daily on minerals, there will be no surprise at this level because I mean, the the modifications on really minor it's purely.
The technical and it does not change on the Hulu.
The type of say the active ingredients of the active part of the Republic, but.
We have been pressure of clearing the protocols on how you do not see any any problems there.
There are beautiful Ah congrats on the on the art, Michael died or as well on top of the <unk>.
I'll jump back in the queue. Thanks.
Thank you so much of March.
Thank you as a reminder of if you wish to ask the question at this time. Please press Star then 1 our next question comes from Jason Butler with JMP Securities. Your line is open.
Hi, Thanks for taking the question.
Just wondering obviously now you have the <unk> data what what are your plans to continue to build awareness of the data and the.
On the drug over the next year or so as you progress through regulatory submissions on.
Obviously presentation of the data at medical meetings, but beyond that any.
Plans to bring on board M S cells or even the non branded awareness campaign or and then secondly, do you have any plans for an expanded access program either here in.
On the U S for Europe. Thanks.
Great question, Jason So obviously, yes.
We'll pause on debt the medical meetings of the I think there are some presentation at the <unk> College of Neuropsychopharmacology and we will launch so the president of the American College of Neuropsychopharmacology end of the year. So definitely yes, we will disseminate them. These data.
As we speak I mean over the last few.
A few weeks when we got the data we have also discussed quite extensively with the somewhat.
Some of our kind of kols. The most involved in advising us, but the menu who ran the much larger.
In order to have the state of becoming aware of 2.2 of a relaunch of <unk>.
Part of the of the sand.
And if he can medical community.
For the for your company.
The broader approach I mean, we might we might think about the.
A webcast.
But we have not decided yet which will really give it.
Again, the complete update about the.
Our.
Big loved ones on our package because I think it is important.
I mean, this is put into the context and passionate people who will also give updates.
Obviously, a bunch of money equivalent study, we will give updates about the pharmacology because I see the.
The pharmacology of <unk>.
The drive these oh containing a very hot topics like the Sigma Sigma targets.
Because the out of the car gets the all of this we will do it but the between today and the hence.
Hence the NDA submitted the I think we will really stay focused on R&D on preparing for the best trial.
And against the stand off towards the new lifestyle for Chia, we will focus on the tons of.
You can puppies she mentioned.
Great.
Thanks for taking the question.
Thank you. Our next question comes from Douglas Tsao with H C. Wainwright Your line is open.
Douglas Tsao of your line is open please check your mute button.
Hello.
Can you hear me.
Huawei here Doug.
Yes, sorry about that.
So just given all the activity that you have going on but obviously you have a lot more freedom now with the royalty pharma.
The <unk>.
Financing.
Just curious given the breath of opportunities how are you thinking of.
That proceeding with other trials for roll of the paradox, if some of the earlier indications or settings that we've talked about.
Obviously, you're prioritizing the NDA submission, but I'm, just curious how you're thinking about that and when we might see some of that other clinical work start.
Yeah.
Obviously I mean the.
This is all in parallel we are we aren't really consciousness of brainstorm on first of all we continue to do.
So to get the maximum out of all of the data. So I'll give you. An example of we are currently working on.
How much of it.
Improvement of negative symptoms is linked the 2 to the functional improvements in the from a.
Net with PSP total score we are also focusing on the <unk> of Oh PSP.
You should remember we have the signal in terms of coordination we also of working conditions.
And with the internally on the resolve of our Kols we are definitely.
Looking on the what would be next.
Hopefully post approval.
In terms of the.
Studies Ashland in terms of.
The studies, which they put the.
Carry out inside the echo ecosystem for schizophrenia, and definitely also trumps getting us so I guess the.
The answer to your question is on <unk>.
Dissipating also having a good understanding of the kidney besides the understanding of what is the right the CRE.
Low to use if you are running a study. So this is 1 of activity because of it.
This is important to have the.
The right setup here, but maybe we are also putting together our plan.
In order to in terms of clinical trials.
The expanding the indications and the.
I'm quite sure sort of I mean this is the point, we will discuss the when we had him.
In our in the in the.
The second half of these chosen as a pre NDA meeting with the FDA. So so we're making sure that had all of the different the.
Options of opening order 2 to run trials.
He is the best conditions for us the best sites as the best organization and I think are slowly, but surely we have no other Larry.
The effective and efficient plans in place in terms of clinical trials, which we can also discuss if needed with the FDA. So we are ready but for the most.
On the first let us have the.
A very good meeting of a regret the final discussion with the FDA before we are starting on your clinical trial.
We are working on it.
Okay, great. Thank you so much.
Thank you and I'm kind of fair.
For the questions at this time I'd like to turn the call back over any of those ringer for closing remarks.
Yes. Thank you so much.
And great day, Thank you for for the great questions and for everybody who participated to this point.
Obviously, it's a very important.
Time for Minerva items is open.
Okay.
The bioequivalence study.
Results will be very simple because it was 1 of the.
Points raised by the FDA during the the type C meeting so I'm really looking forward to update you very soon on all of this on the rest of the progress we're making because we are also working on.
Just because it's such a day, but youre working on all of the preclinical package.
Putting all of this endeavor.
NDA package, so lots going on on I'm looking forward to updating of everyone. Thank you for all for participating.
Ladies and gentlemen. This concludes today's presentation. Thank you once again for your participation you may now disconnect have a great day.