Q1 2021 Anavex Life Sciences Corp Earnings Call
Good afternoon. My name is Aaron and I will be your conference call. Operator today welcome to the end of <unk> life Sciences of fiscal 'twenty and 'twenty, one of first quarter conference call.
During this conference call is being recorded I would now like to introduce your host for today's conference Clint Tomlinson Sorry go ahead.
Thank you and good afternoon, everyone.
We appreciate you joining us today for <unk> Life Sciences conference call and webcast are.
Our agenda is to review the company's financial results for the first quarter of its fiscal 2021 financial year and provide.
Clinical study and business update.
The tape delay of this call will be available approximately two hours after the call's conclusion and will remain available for one month the.
The call will also be available for replay on <unk> website at Www Dot <unk> Dot com.
With us today is Dr. Christopher misled.
President and Chief Executive Officer, and Sandra Burnish Principal financial Officer, Dr missiles, and Mr. Furnished will make prepared remarks, and then we'll take questions from equity analysts before we begin. Please note that this conference call. The company will make some projections and forward looking.
Statements regarding future events, we encourage you to review the Companys filings with the SEC. This includes without limitation. The Companys forms 10-K, and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward looking statements.
These factors may include without.
Without limitation risks inherent in development or <unk> commercialization of potential products on.
Uncertainty in the results of clinical trials or regulatory approvals need and the ability to obtain future capital and maintenance of intellectual property rights.
With that I'd like to turn the call over the Doctor Misaligned.
Thank you plan. We appreciate everyone joining us on today's conference call to review all of the financial results and business updates.
I would like the first share with you our recent clinical and pipeline updates.
Let me start with Ret syndrome.
Based on recent phase II U S Ret syndrome.
The trial data.
Which showed positive clinical activity and safety data.
Potential accelerated approval strategy planning is underway.
As the progress with ongoing phase II, <unk>, III Avatar adult ret syndrome, and phase II phase III excellence.
Did you Arctic Ret syndrome studies.
At the same time.
The FDA has approved an extension of.
One of <unk> 273 U S Ret syndrome Phase II open label extension study.
From 12 week to 36 weeks.
In Australia on.
The VIX received compassionate use special access scheme approval for Ret syndrome patients to continue treatment with other <unk> 273. After completing the other to adult Ret syndrome clinical extension study.
This is very good news flow the patients.
And as a reminder, we had previously received compassionate use, especially the access scheme of approval for some of the disease in Australia.
On the VIX has sufficient unethical to seven three drug substance available to support all ongoing and planned clinical trials.
And first of your commercial launch.
Meats for the Ret syndrome program.
And all of the next two to three drug substance in the oral solution exhibit excellent chemical stability based upon three years of stability data in both cases that is very important.
Let me now briefly switched to Parkinson's disease, we announced recently that <unk> has been awarded of research grant of nearly $1 million.
From the Michael J Fox Foundation for Parkinson's Research.
So the develop of the VIX Tcf of Threep for the treatment of Parkinson's disease to explore utilization of pet imaging biomarker.
Which demonstrates the continued focus.
On the potential disease modifying treatment for Parkinson's disease.
As a reminder.
Of our clinical strategy is clearly differentiate it.
From other Biopharma companies and clinical studies in central nervous system.
All of the VIX is continuing to pioneering the approach of big data and clinical trials to leverage the relevance of phenotypic and Genotyping precision medicine analysis of.
Full exome sequencing.
And gene expression data and drug development and in particular.
Tension to identify patients genetic variance and gene expression changes that may predict increased chances of success of ret syndrome, Parkinson disease and awesome of disease treatments.
We got it out some of this.
Regarding Ultima are very important scientific finding emerged recently.
Researchers at the University of California, San Diego have identified the underlying cause of of somebody in Europe. They.
They discover the changes in the structure of chromatin are responsible.
Sigma one receptor the Derrick targets, which gets activated with unethical to 73 demonstrated to restore chromatin structures.
In published experiments on the VIX true same three has been also linked to the prevention.
And treatment of age associated diseases through induction of the toughest <unk>.
Cellular recycling process and.
The <unk> enhanced protein clearance and cell, which is relevant in these diseases.
On the mix to seven three is currently in the face to be slashed III awesome of disease clinical trials.
Utilizing differentiate it Pete patient selection criteria and the studies presently over 86% enrolled and randomized.
Lastly, let me also briefly switch to our new clinical pipeline compounds I'm the big three.
The 71.
Which is currently in the phase one.
And is on track independent.
The independent data safety monitoring board he is M b for the company's phase one study.
All of its new investigational compound out of 371.
Also a small molecule activating the Sigma one receptor.
Has completed its recent pre planned review of.
Of the preliminary phase one safety data.
The tears and be recommended to continue the study without modification and that is a very positive outcome.
And now I would like to direct the call. It the Sandra Burnish principal financial officer on the VIX for a brief financial summary of the recent reported quarter.
Thank you Christopher and good afternoon, everyone.
We reported a net loss of $7 9 million for the quarter or 12 cents per share.
As compared to $6 6 million also talks of earnings per share in the comparable quarter of last year.
Research and development expenses were $7 9 million for the quarter compared to $6 3 million in the comparable period.
While general and administrative expenses remained unchanged over the comparable period.
Our clinical trial expenditures continued increased gradually as enrollment progresses and the trials expand internationally.
We reported an increase in other income to $1 6 million for the quarter as compared to $1 1 million in the comparable period.
This increase is related to research and development of incentive income in connection with our Australian clinical trial activity.
Lastly, as of today, our cash balance is approximately $75 million, which is expected to be sufficient for providing the runway of up to three years.
Our cash position at December 31st 2020 was $47 4 million.
Thank you and now I will turn the call back over the Doctor messaging.
Thank you Sandra.
In summary, we.
We are thrilled to begin the new year with the strong business outlook.
Which will allow for a multiple.
Near term data announcements combined with continued fiscal responsible management of resources.
This adds to the breadth of strong clinical data, we've reported across all of precision medicine pipeline.
Using orally once daily of April on the VIX to seven Threep for Ret syndrome, hawkinson disease dementia and at some of disease.
We look forward to providing on the timely basis in 2021 multiple clinical data readouts from these clinical programs.
The converging biomarker driven clinical data and for the molecule of understanding of our biologic of target the Sigma one receptor.
The giving us added confidence.
Our efforts to meet our goal of potentially bringing new therapeutic interventions to patients.
The other clinical milestones are provided in our latest corporate presentation.
Available on Www dot on the VIX Dot com.
We are very excited about this year before us and we look forward to continued new data updates throughout 2021.
I would now like to open the call for questions.
Please go ahead.
At this time, we'll be conducting a question and answer session for equity analysis that you'd like to ask a question. Please press the star one on your phone the confirmation tone will indicate your line is in the question queue or are you in the past the turnkey if you would like to remove the question from the kill the first question that comes from Charles Duncan with Cantor.
Your line is open.
Yes. Good afternoon. Thanks for taking my question and congrats on the progress Chris and team had a couple of questions first on the Ret program with two dash debt 73, I'm wondering with regard to the U S. Ret study when would you anticipate.
Able to provide additional details from that study.
Congratulations on being able to extend the open label extension of that study from 12 weeks of 36 weeks, but can you help us understand a little bit kind of of the rationale for that extension of the study and what is the percentage of patients that have enrolled.
<unk> continued on into the study in that in that extension phase.
Thank you for the question, let me start with the the lost trust. So from the patients who finished the placebo controlled part of the U S study of 100% all patients continue continued in the extension study.
And the reason for the extension of the extension by the <unk>.
Six months.
Does the interest from the participating.
Patients and families as well as the ability to continue to learn and add long term safety data.
Full of Ret syndrome patients with our compound.
Regarding the first questions, we actually have not.
Not yet a.
Fully released the priest.
The precise.
The data on the Ret syndrome outcome.
The baseline.
The situation of the RSP Q and the other net.
Asia as well as the precise changes and this can be done relatively near term and will be deter them together with what we have prespecified in the protocol and the N D. S. P.
The genetic.
The feature of the biomarker.
The effect of the Sigma one variance, which we identified previously and the clinical phase Iia study in the ultimate patients. So the answer is that this can be relatively near term to provide.
More details on exactly the outcomes of.
The study measures measured.
Okay, we'll look forward to that Christopher would you anticipate it with.
In conjunction with an upcoming psychiatric or neurological meeting or one that specifically driven.
You know I guess from the rat.
The kids he community.
Yes, so the community only his interest in learning more about it and we're happy to provide it.
As soon as we can in order to get the data because its varian data requests a genetic analysis, which is not a was not ready the available until now, but we will have it soon.
The either do this in a conference, which we find the timely and suitable or we will provide it in a press release with a very been very in the art together and that will allow for everybody to be informed about the state Oh.
Okay. One last question on rent how can you provide any color on how the pediatric trial excellence is going and then the adult trial avatar and when would you anticipate being able to read out those two studies.
So we think the trials are proceeding well we've stated that the other type of study will be the.
The readout of within the first half of this year and the excellent study in the second half of the C. L.
Right now all of the latest update.
The update in time, the time expectation on the studies.
Okay and then my last question is on the Parkinson's disease.
Site for two dash seven three not of lot of companies have had success in parkinsons disease dementia, and I guess I'm wondering with your provocative.
You know data that you spoke about recently I believe the was at sea Tad last last year. What are the next steps for that program could we see that move into a later stage study this year and would you be seeking agency.
The guidance guidance on that.
Yeah.
So we have noticed.
Debt they were at least three Parkinson's disease dementia studies, which have failed.
With other companies recently and that shows that Parkinson's dementia is the extremely difficult gaudy too.
The execute and wheel of fortune that all of the study.
Was positive and of what we're now doing and we pointed that out when the data came out at sea Ted debt, we have no gathering the entire.
The understanding of the participating patients the background information the Corp.
Nation with the outcome and then present that data to the F. D. A to the agency in order to seek guidance and to agree on the pivotal study design, which we would then undertake of based on debt the detailed data for patients with Parkinson's.
And the disease dementia.
Okay final question regarding the platform then I'll hop back in the Q3 Dash seven one new new candidate.
Congrats on moving that one forward, but can you tell us anything about that that candidate relative to two dash seven three.
How does it differ is it from a different chemical series does it have different brain penetration different pharmacology, what any color on that would be helpful.
So what do we know about under the X 371 is that it is a completely different molecule. It was.
Licensed in from the Weizmann Institute and is in Israel, and we developed all the necessary preclinical data technology manufacturing CMC.
To bring it to where it's now and what.
What we do know the difference of two and three are two fold.
On the next 271 is a strong affinity to the Sigma one receptor.
<unk> is also a more pronounced.
Muscarinic in one of affinity and other expense of three which has more of.
Affinity to our two other muscarinic receptors, but much in a much weaker of point, so we will really need to see the.
In the direct one of them.
Comparison, how they are playing out.
What we have noticed that we received for under the 371, often does the drug designation by the FDA for Frontotemporal dementia.
And you might bring 371 towards the.
Indications first which are not competing with one of the extra assumed three directly.
But.
We are very excited that we have another compounds with the same valuable target of Sigma one activation, which is it turns out to be so important biologically debt. We can use this also for indications, which we have not yet covered.
Two simple III.
Excellent. Thank you for taking my questions Christopher Good luck for the pipeline progress this year.
Thank you.
And your next question in queue comes from around the solid Roger with H C. Wainwright. Your line is open.
Hi, Thanks, very much for taking my questions and congratulations Chris on the all of the recent progress I wanted to just the first of all start off with the few questions regarding the Ret syndrome program.
I was wondering if you could elaborate upon you know any additional gating items assume.
Assuming that the data from the upcoming studies is positive you had mentioned previously that this could potentially.
Serve as the basis for our Reg.
Our regulatory submission in the United States, but I wanted to gain a better understanding of what additional gating items, there may need to be or that there still are.
As you go through the steps and potential of preparation of an M. D. A.
Secondly, just wanted to clarify whether this program if it were to be the subject of our ultimate.
Ultimate regulatory approval would qualify you for the receipt of a priority review voucher and then thirdly, if you could maybe comment a little bit on the nature of the ret syndrome competitive landscape as it currently stands and where you expect that to be at the time when the block comments you might potentially be introduced into the market at the true.
<unk> for Ret syndrome, and also if you could give us a sense of what might be required for the launch.
Drug life block kind of the team into the rest of syndrome population. Thank you.
Right. So the first question was about gating items. So we are.
Doing the same what I mentioned for Parkinson's dementia, which is the entire genomic Soma analysis, which is part of the clinical study.
We want to prepare the package and meet the FDA and share the data with the FDA.
The.
The additional data from other Tau and <unk> excellence will be supportive and I expect it to be supportive.
The.
Our ability to get the voucher is given our debt we have fostered with foster designation and orphan designation and we also have the voucher eligibility. So that also has a positive answer if the patriotic study is positive.
Regarding the landscape of.
Its herd and learn debt one of the competitors in the rest of them has dropped out.
Entirely which is GW pharma day initiative or and ease of <unk>.
Stopped because of the Covid.
Situation the trial and.
And we tied entirely the program and Ret syndrome.
Which is a positive for us we believe in the fourth question is regarding marketing.
The extremely good relationship with the of.
But community with the Ret syndrome Foundation, and not only in the us, but especially in the U S. But also around the world and we understand the dispositions of background of the physician center for Ret syndrome descent of accidents, very well and this is really a clash of truecar.
Base, where our company can move into marketing of the truck.
All the cells. Like example is shown.
Like Alex soon and the other comparable accompany the CIT successfully.
<unk> successfully launched a drug in the rare disease setting in the size, we have an attendance with ret syndrome.
Very helpful. There also I was wondering if you could comment on the current status of the the spec.
The access scheme in Australia, and whether you think that that's a element of the overall of Ret syndrome program is likely to yield usable or significant clinical data that you could use in support of a regulatory application and if you could maybe give us the sense of what the size of the.
The program is right now you know how many patients are receiving drug as part of the Fas.
The suite.
The compassionate use program in Australia is the benefit that it allows for patients who are on the clinical study and after finishing the study on the extension study and after finishing the clinical extension study.
Basically being left up without any further treatment.
And that allows them to continue the drug with the supervision of a physician physician and right now we limit the.
Pretty much to the existing patients, which entered our study and the.
The advantage is that once the drug will get approved they will be obviously automatically becoming eligible then to be prescribed the drug when it once it's approved for market authorization.
Yeah.
Okay, Great just a couple of more from me.
I was wondering if you could comment on the REIT.
Such activity in the Alzheimer's space and the fact that.
That seems to be a great deal of more enthusiasm at this juncture for.
Proof of concept.
Nicole it results in Alzheimer's disease, and I think part of that can be attributed to anticipation that perhaps with a favorable regulatory decision on other counter mob the.
Post may have been moved actually a little further apart and in point of fact.
Process by which Alzheimer's drugs get approved could conceivably be construed is getting easier.
Potential of reflection in fact of the.
Severe unmet need out there, but what are your thoughts regarding what the regulatory environment might look like in a post IPO kind of map of approval situation and what implications that has for your Alzheimer's program.
Over the I cannot predict what will happen on June 7th when the meeting from the FDA will take place to decide about all do but I would say that if it turns out positive and that is of scenario you referred to it would actually mean that the FDA would.
Agree that one.
Robust clinical study would be sufficient to approve a drug in the off some of the disease and since we're running though a robust phase two be schedule III study as well.
Could be.
Uh huh of positive for us in that regard.
If the decision on the seventh of June is a more negative and the outcome then it would still not of.
Believe it or not in way of shape.
In the in pit because we are basically by the time advanced with all of the study and there's also ability for.
The supportive data from the phase Iia with all of Phase two phase three studies. So we just put our heads down and move ahead, but I would think that it's possible that there will be positive.
The residence if the study would be approved of the other study would be approved mid of the year.
Okay, Great and then just three other very quick ones firstly.
Assuming you have positive data of indirect syndrome, what implications might that have for future development of the common theme in other orphan neurological diseases and can you elaborate at this juncture you know what.
Would potentially be your highest priority choices with regard to future orphan CNS indication development secondly.
What is the significance from a commercial standpoint of the oral solution.
In particular as it pertains to Ret syndrome, I think you know we may have touched upon this in the past that.
It's worthwhile reiterating that and then lastly, I was wondering if you could comment at this point about the possibility of co formulation co administration of synergistic combination of block kind of as seen with other compounds in the honour of X pipeline and if that's likely to be the case if that is something.
That you think might be something you wind.
Windup exploring in the future, which other compounds or which other types of compounds from the honor of X earlier.
The earliest stage portfolio might be likely to be most synergistic with my comments.
Right. So the the first question.
Regarding the second because we got the solution I think it is a very strong advantage because many of these kids of girls are they have a hard time swallowing some even.
Cannot even eat they have a artificial of pouch two of two of feeding tube and liquid formulation is the only way actually to provide drug substance to the patients other than by injection, which is very ugly inconvenient and cumbersome. So there is a very strategic.
The advantage of of Detour Pudic administration.
The first question regarding what what could trigger the.
The approval of of Ret syndrome.
We have seen the unethical to seven three years been extremely strong in preclinical studies. The two also effect the pathology of fragile X, which is autism spectrum disorder.
Well as infantile spasm, and Angelman syndrome, and other rare disease, there's all three of these.
This is the refrigerant X is the largest rare disease of the autism spectrum disorders, and with a multiple of the patients then the ret syndrome patients.
So since we all have very strong preclinical data and ret syndrome happens to be a part of the autism spectrum disorder.
Given now we have basically.
The support of data very strongly the pre clinically in clinical in the Ret syndrome. We have now very strong in support of Steve are in particular and free.
The next we believe that the chances have increased to also be of successful in a clinical study in fragile X and that's why we're planning and we already have developed the study.
Study design to move into fragile X is the next study of.
On the mix within the three.
Regarding the last questions about synergies Oh, we don't know if the synergy with another six per one agonist might be the best choice I would rather thing that of synergy could be with other compounds targeting other.
Other <unk>.
Our other pathways like if I do will get approved we believe it would be synergistic to Olympic Suzanne three because it is a different pathway, but also we have seen that on of extras and three has been shown pre clinically to prevent the disease. So it's not only the treatment, which is the goal and that's.
What we know finding out with our ongoing phase III study in on some of these but also thinking ahead strategically that one day of the VIX, which of three could be used as a.
The daily Amelia aspirin potentially too to avoid being coming in given the near to be.
In the situations, where you get affected by afflicted by such a horrible disease like some of these.
Many thanks.
Thank you.
And your next question in queue comes from Robert Leboyer with Ladenburg Thalmann. Your line is open.
Hi.
Quick question on 373.
The I did mention that the D. S M D.
Yeah.
Recommended continuing the trial. So I was wondering how long. This can continue for when we might see results and if per.
Positive when that might move forward and also in the <unk>.
Since the program.
I see.
The data from from November of included sort of secondary endpoints is there any plan or anything where you might be presenting the full study data.
On the Parkinson's Ah trial.
Right. So first question the 371 of we have several.
Panels in the phase one and the first two panels spores.
A signal of ascending dose.
And that was very impressive debt we got this.
Green light to move forward now in the panels off of.
Going into the female male the effect, if the differences as well as a recurring treatment as well as foot.
The effect of the drug so basically the most of if you select the the most important hurdle of the phase one is like those of sending the was well tolerated.
To the highest dose of planned dose was positive that is the most oh, it's the crucial information about this phase one study and they'll come to just the losses of the phase one we said that we wouldn't have the data within the first half of the 2021 I think it looks like it will be the earlier.
Earlier than the.
Not waiting until.
Of the the June time frame, but much earlier than that given where we are with the study regarding the second question.
I think remind me of getting the question. Please.
That had to do with the presentation of the full start of the PDD right now excellent question. So the C. Tech was really focused on the dementia portion of the study the dementia portion of the PDD studies what is now.
We'll come out and we will present it.
In the proper fashion, either at a conference or in the peer reviewed form or in a in the webinar or.
The the fashion.
We will provide the entire data of all of the other measures of the.
The system, which of them anymore than the ones presented its heated which also was a very short time frame of presentation of only 10 minutes. So we have the effect of it in and it was also include the Actigraphy data and the other.
Other data related to Parkinson disease. So this will be something which we are also planning to present on a relatively relative to short notice and so so in order to have the the full picture of PDD and the same applies.
Here. This data this aggregated data will be put in front of the FDA and to seek guidance in order to design a pivotal studying PDD.
Great.
Did you mention any plans to move.
Sure.
Into clinical trials this year.
Right. So one of the targets of one of them of.
Anticipated milestones, which we have provided.
At the last call was too in the.
The shape of fragile X clinical study and we will do that with the guidance from the FDA.
Also I'd like to mention that we have submitted a paper.
Of the entire preclinical package of preclinical data for fragile X with the VIX was of three and we expect that paper to be.
The.
To be published.
Published eventually and hopefully soon so this will be the entire preclinical data package of fragile X of other VIX was given three which should and will make the case of strong case of.
That the the moving fragile X with the kind of exercise of three into the clinic as warranted.
Great.
Okay. Thank you very much.
Thank you.
The next question in queue comes from Tom Bishop with D. R of research your line is open.
Hi.
Christopher.
The little puzzled.
The.
The back in November you said you were 80%.
Over 80% enrolled and now youre, saying, 86% enrolled.
Yes.
Quick math six per cent of 40 to 50 is only about 27%.
Patients in the last three months, which is.
What am I missing here about the complexity of of sort.
So any of this up.
So you have to appreciate that before the last time, we spoke and no. It wasn't of December was the holidays and during the holidays, there's literally a full stop in enrollment and the activities of such.
Things.
We also want to point out that we added more sites and I think there will be an escalation from now on so I don't think debt is too much to worry about the other end of we don't pin pointed out that we want to make sure we're getting the right patients into the clinical study.
And we have a very.
The solid the screening process to make sure that they are fulfilling the requirements of intrusion.
Of the study.
So the rather want to have the right patients then enrolling to quickly enable the wrong patients.
That's basically the background, but really I would not read too much into this is the literally really it's the holiday switch left led to this.
Relatively but I think we're very comfortable that the victory of very good enrollment compared to other companies.
Okay. So how many sites are enrolling right now.
I think if I'm, adding all of its between.
The around 40 to 40 almost 50.
I have to Oh.
The count again, all of those sites, but we added sites in Germany, and U K in Canada in Netherlands.
Okay, well then.
Still hoping for early 2021.
And do the enrollment.
Yeah, we have not changed it and we said the data announcement of the data, which actually of what medicine will be in the first half of 2022 is it the.
Year after the loss of patients gets enrolled.
And then you have to add also the time for.
The data lock and data clean so that's but the timeline is still unchanged from that.
Okay and regarding the $75 million in the bank as of today does that indicate that you've been able to take advantage of the recent.
The increase of the stock price, maybe with your ATM or.
That was a big jump given that you've also had a quarter of spending.
From the West right I think it was 48 two.
I myself have been hoping that he's been able to somehow use that ATM.
These higher prices and not have to dilutive the.
The share is it right.
It's an excellent point and what did you ask this question Tom.
Really fortunate that we have this this tool in place and it was exactly meant to for that reason to win there's really an unexpected positive the share price moves that we are able to with leased the dilution to basically use this tool in order to a mixture.
<unk> share holders are the least dilutive way possible of course.
<unk> two <unk>.
Progress and work because without capital we cannot bonds of assets as you know and that was possible.
In the last two weeks to do that that's right.
Okay. So how many shares are the outstanding now.
It's obviously very fortunate to take advantage of this stopped the move but I think the details will be provided in the next Q, which will show up early next week because of all of the the latest filing.
It will be on Monday, because of the Mondays of holidays. So it will be next week Tuesday, most likely.
So you'll have the share count on the cover of the 10-Q.
Exactly right, yes, okay, but it will be if you could figure out of at least dilutive possible. So it will be not by much.
Okay. So if VA.
Okay.
Has the proven that interim data.
Maybe allowed me allow a company the start on the phase III trial.
The phase two b was three.
The trial is still.
Continuing.
If my perception of the news is correct. So is there any more thoughts of.
And.
Interim.
Readout.
Or maybe I didn't come from.
All of them in this so.
I tend to try the trial, you're referring to is an open label study so that is a different situation.
Asian, you have here.
But I just want to point out that we obviously are the almost.
Almost completing the.
The randomization of our phase III study, if you sort of like.
What are the.
The other company you mentioned still has to start.
The other point of trying to make of that we have of the program in ret syndrome.
Which could generate revenue revenue.
The pretty soon by itself. In addition to Parkinson's disease dementia data, which also is a unique floor of fun of X. So I think we're in a good position and we just are.
Making progress as we go.
As regard to an interim analysis of the phase two b three.
While for Alzheimers.
The so in theory, it's possible and there is a chance of does it it's a possibility in the <unk>.
Protocol, it's allowed to do that.
If we do that I don't know yet and I think we will let the the discussion with the with the F D a guidance on that.
So the possibility of suddenly there.
Well the.
This is my understanding correct that it is it possible debt.
That the interim data from this study.
It enables you to get going already on the phase III study, even while the.
The full readout.
The full enrollment and readout of the <unk>.
As <unk> III study is ongoing.
Well the phase II B cell C is our phase III studies so.
We think that is a pivotal study.
Okay.
And I think if I understood somebody else's question. He was fading in and out of my line was the.
The targets in the physical data, we're still awaiting that rate.
The genome data and the Parkinson.
The other actigraphy data and so forth of just what you from that won't be presented data and then there is that the effect on Parkinson's itself, which I think right on the movement. That's correct. This is what I've mentioned, we will release the data.
In short order once we have it altogether and that will be something we will present either of the conference or in the that'd be north of.
For everybody to see exactly of the effect of the drug in these patients.
Alright, Thank you very much Christopher.
No I appreciate it thank you.
Okay.
Thank you ladies and gentlemen, this concludes today's questions and today's conference. Thank you for participating you may now disconnect.
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