Q1 2024 Anavex Life Sciences Corp Earnings Call

Good morning welcome.

Clint Tomlinson: Good morning. Welcome to the Anavex Life Sciences Fiscal 2024 First Quarter Conference. My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in a listen-only mode.

Welcome to the <unk> life Sciences fiscal 2024 first quarter conference call.

My name is Corey Tomlinson and I will be your host for today's call.

At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and during this session if you'd like to ask a question. Please use the Q&A box or raise your hand.

Clint Tomlinson: Later, we will conduct a question and answer session. And during this session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note, during this conference, this conference is being recorded. The call will be available for replay on Anavex's website, at www.anavex.com. With us today is Dr. Christopher Misling, President and Chief Executive Officer, and Sondra Bohnish, Principal Financial Officer.

Please note during this conference.

This conference is being recorded call will be available for replay on <unk> website.

At Www Dot <unk> dot com.

With us today is Dr. Christopher Metz, Lang, President and Chief Executive Officer, and Sandra Burnish.

Principal financial officer before.

Clint Tomlinson: Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC. These include, without limitation, the company's 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.

Before we begin please note that during this conference call. The company will make some projections and forward looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties we.

We encourage you to review the company's filings with the SEC. This includes without limitation the company company's 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.

Dr. Christopher Misling: These factors may include, without limitation, risks inherent in the development and or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and Maintenance of Intellectual Property Rights. With that, I would like to turn the call over to Dr. Misner. Thank you, Clint, and good morning, everyone.

These factors may include without limitation risks inherent inherent in the development and commercialization of potential products uncertainty in the results of clinical trials or regulatory approvals need.

Need and ability to obtain future capital.

And maintenance of intellectual property rights and with that I would like to turn the call over to Doctor Midland.

Thank you Glenn and good morning, everyone.

Dr. Christopher Misling: Thank you for being with us today to review our most recently reported financial results and to provide our quarterly business update. We are poised for a very exciting year for Anavex. In December, the Committee for Medicinal Products for Human Use within the European Medicines Agency agreed that oral black camisole for Alzheimer's disease is eligible for submission of an application for a union marketing authorization in the EU under the European Medicines Agency centralized procedure. The market authorization would allow direct market access throughout the European Union for oral blockamazine for the treatment of Alzheimer's disease. We are actively engaged in this process and aim to submit the market authorization application as early as possible in 2024.

Thank you for being with US today to review, our most recently reported financial results and to provide our quarterly business update.

We are poised for a very exciting year for <unk>.

In December the committee for medicinal products for human use within the real pain medicines agency agreed to the oral that Cummins in for Alzheimer disease is eligible for submission of an application for a union marketing authorization in the EU under the European medicines.

Agency centralized procedure.

The market authorization will allow direct market access throughout the European Union for oral black cognizant for the treatment of Alzheimer disease.

We are active akeley activity active actively engaged on this process and aiming to submit the market authorization application as early as possible in 2024.

Dr. Christopher Misling: Full data from the glaucamazine in Alzheimer's disease phase 2 slash 3 randomized clinical trial are forthcoming and will be published in an upcoming peer-reviewed journal. Also, we'd like to mention that the respective Open Label Extension 96-week trial, ATTENTION-AD, is ongoing. Top-line data from the Anavex 273-RA03 Phase 2-3 Excellence Pediatric Clinical Trial were announced last month. We intend to further assess the results and discuss with the regulatory authorities next steps. A high enrollment rate into the OLE, Open Label Extension, of over 91%, as well as the high level of requests for the Compassionate Youth Program of 93%, provide solid numerical evidence for the positive real-world evidence reported by patients and their caregivers with Rett syndrome under Compassionate Youth Authorization. Previously, we announced the first complete clinical gene pathway data from the Anavex 273RS02 AVATAR Rett Syndrome trial. We believe that this is the first time a whole genome exome analysis comparing drug and placebo in patients with Rett syndrome has been performed.

Full data from the Black Compazine in ultimate disease Phase II Slash three randomized clinical trial is forthcoming and will be published in an upcoming peer reviewed journal.

Also we'd like to mention that the respective open label extension 96 week trial attention a D is ongoing.

Topline data from <unk> 273, or <unk> three phase II slash three excellent patriotic clinical trial was announced last month we.

We intend to further assess the resolve and discussed with the regulatory authorities next steps.

Our high enrollment rate into the OLED open label extension of over 91% as well as the high level of request for the compassionate use program of 93% provide solid numerical evidence for the positive real world evidence reported by patients and their caregivers with ret syndrome under.

Compassion use authorization.

Previously, we announced the first entire clinical gene pathway data from the <unk> 273, Rs zero to Avatar Ret syndrome trial. We believe that this is the first time, a whole genome exome analysis, comparing drug and placebo in patients with Ret syndrome was performed.

Dr. Christopher Misling: And we believe the results confirm that Rett syndrome is indeed a neurodevelopmental disorder with a key metabolic component, which can be addressed with therapeutic intervention and is likely relevant for other neurodevelopmental diseases as well. As related to Anavex PreCenter, our second clinical small molecule, we were pleased to announce the initiation of the U.S. FDA-cleared placebo-controlled phase 2 trial of Anavex 371 for the treatment of schizophrenia, which Regarding the Parkinson's disease program, we are in preparation to initiate the Anavex 273 imaging focus trial and the Anavex 273 phase 2b slash 3 six-month trial. For Fragile X, we believe new disease-specific translatable and objective biomarker data generated recently with Anavex 273 should strengthen the support for the initiation of the potentially pivotal Anavex 273 phase 2 slash 3 clinical trial in Fragile X.

And we believe the results confirm that ret syndrome is indeed, a neurodevelopmental disorder with a key metabolic component, which can be addressed with therapeutic intervention and is likely relevant for other neurodevelopmental diseases as well.

Related to <unk> recently launched our second clinical small molecule. We were pleased to announced the initiation of the U S. FDA cleared placebo controlled phase II trial of <unk> 371 for the treatment of schizophrenia, which is expected to begin in the second quarter of <unk>.

Linda 2024.

Regarding the Parkinson disease program, we and preparations to initiate the unethical to seven three imaging focus trial and <unk> 273 phase two b slash three six months trial.

For fragile X, we believe new disease specific translatable and objective biomarker data generated recently with analytics system three should be strengthening the support for the initiation of the potentially pivotal <unk> 273 phase two phase three clinical.

Dr. Christopher Misling: Related to a new rare disease, we are also in preparation to initiate a potentially pivotal Anavex 273 phase 2 slash 3 clinical trial. We're also expecting further peer-reviewed clinical publications involving Anavex 273 and Anavex 371. Last month, we announced a new peer-reviewed publication in Clinical Pharmacology and Drug Development, findings from Anavex 371, the first in human study, which achieved its safety objectives. The publication is entitled Population-Based Characterization of the Pharmacokinetics and Food Effects of Anavex 3-Cellulose, a novel sigma-1 receptor and allosteric M1 muscarinic receptor agonist in development for treatment for frontotemporal dementia, schizophrenia, and Alzheimer's.

Right.

In fragile X.

Related to our new rare disease. We're also preparations to initiate our potentially pivotal unethical to tier three phase two phase three clinical trial.

We are also expecting further peer reviewed clinical publications involving <unk> 273, and <unk> 371.

Last month, we announced a new peer reviewed publication in clinical pharmacology and drug development finding some other VIX. Please send you one first in human study, which are key achieved its safety objectives.

The publication is entitled population based characterization of the pharmacokinetics and food effect of Unmixed recently won.

A novel Sigma one receptor an allosteric emlen muscarinic receptor agonist in development for treatment for Frontotemporal dementia schizophrenia and ultimate disease.

Dr. Christopher Misling: The publication reports some of the kinetic dose proportionality of Anavex 371 in humans, and food had no effect on the PK of Anavex 371. This is very good news. And this data also expands the safety objectives met in this first in-human study of Anavex Prusimniva, further supporting its drug development program. And lastly, also last month, we announced the extension and strengthening of our patent portfolio with the United States Patent and Trademark Office granting a new U.S. patent entitled Neurodevelopmental Disorder Therapy. Anavex's newest patent expands coverage of Anavex 2Sim3 therapy to ameliorate various conditions associated with loss-of-function mutations of the gene-encoding MEGT2 protein.

The publication report some awkward genetic dose proportionality of Enel <unk> 71 in humans and food had no effect on the PK of analytics 371.

This is very good news and this data also expand the safety objectives met in this first in human study of <unk> recently won further supporting its drug development program.

And lastly, also last month, we announced the expansion and strengthening of our patent portfolio with the United States patent and trademark office granted a new U S patent entitled Neurodevelopmental disorder therapy from the United States patent and trademark office.

<unk> newest patent expands coverage of 273 therapy to ameliorate various conditions associated with loss of function mutations of the gene encoding mccabe to protein.

Sandra Bernisch: And now I would like to direct the call to Sandra Bernisch, Principal Financial Officer of Anavex, for a financial summary of the recently reported quarter. Thank you, Christopher, and good morning to everyone. I'm pleased to share with you today our first quarter financial results for our 2024 fiscal year. Our cash position at December 31st was $143.8 million. During the quarter, we utilized cash and cash equivalents of $7.3 million to fund operations.

And now I would like to direct the call to Sandra Burnish principal financial officer of analytics for a financial summary of the recently reported quarter.

Thank you Christopher and good morning to everyone.

Im pleased to share with you today, our first quarter financial results from our 2020 for fiscal year.

Our cash position at December 31st was $143 8 million joined.

During the quarter, we utilized cash and cash equivalents of $7 3 million to fund operations.

Sandra Bernisch: At our current cash utilization rate, we believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years. During our most recent quarter, general and administrative expenses were $2.6 million, which is consistent with the immediately preceding fourth quarter of fiscal 2023. Our research and development expenses for the quarter were $8.7 million, as compared to $10 million for the most recent fourth quarter of fiscal 2023. And lastly, we reported a net loss of $8.6 million for the quarter, or $0.11 per share.

At our current cash utilization rate. We believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years.

During our most recent quarter.

General and administrative expenses were $2 6 million, which is consistent with the immediately preceding fourth quarter of fiscal 2023.

Our research and development expenses for the quarter were $8 7 million as compared to $10 million for the most recent fourth quarter of fiscal 2023.

And lastly, we reported a net loss of $8 6 million for the quarter or <unk> <unk> per share.

Dr. Christopher Misling: Overall, we plan to continue to be fiscally responsible, and we believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years. Thank you. Back to you, Christopher. Thank you, Sandra. Not only have we demonstrated that we continue to be fiscally responsible, but this is also an exciting time for the company, and we're very excited to be entering a new phase of the company's history with our biomarker-driven precision medicine programs. I would now like to turn the call back to Clint for Q&A. Thank you, Christopher.

Overall, we plan to continue to be fiscally responsible and we believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years.

Thank you back to you Christopher.

Thank you Sandra.

Not only have we demonstrated to continue to be fiscally responsible of this is also an exciting time for the company and we're very excited to be entering a new phase of the company's history with our biomarker driven precision medicine programs I would now like to turn the call back to claim for Q&A.

Thank you Christopher.

Clint Tomlinson: We'll now begin the Q&A session. If you have a question, please raise your hand or enter it into the Q&A box. Our first question is coming from Jones Research, and I'm assuming this will be Schmidt-Roy. Hi Clint.

We will now begin the Q&A session. If you have a question. Please raise your hand oriented enter it into the Q&A box.

Our first question is coming from Jones research and I'm, assuming this will be Schmidt ROI.

Hi, Glenn Hi, everyone. Thank you for taking my question.

Unidentified Analyst from Jones Research: Hi everyone. Thank you for taking my question. A few on the timeline point of view for the Alzheimer's program. What is the expected time for?

A few on the timeline point of view for the asthma program.

What is the.

The expected time for <unk>.

Dr. Christopher Misling: submission of the publication for the Alzheimer's data, and when are you thinking of getting the submission for the European filing done up this year? Both are in progress, and we cannot provide timelines because the paper's review process is not in our hands. The timelines. There are different average times for these, so it's hard for us to assess them.

Submission.

The the publication for the asthma data and when are you taking to get the submission for the European filing done this year.

Both are in progress and we cannot provide timelines because the papers review process is not in our hands the timeline they are different.

Average at times for these so it's hard for us to assess it but I think we are in the right path here regarding the muscle mission, we said that we like to do this as soon as possible in 2024, and that's exactly what we're doing so we are really very active on preparing every mall.

Dr. Christopher Misling: But I think we are on the right path here. Regarding the EMA submission, we said that we would like to do this as soon as possible in 2024, and that's exactly what we're doing. So we are really very active in preparing every module and submitting it. Can we expect this to be a first-half event?

Module and to submit it.

Should we expect these to be first half event.

More like what I would rather Faye we've tried to do our best I would we would provide an update once it gets submitted but it's really not.

Dr. Christopher Misling: I would rather say we try to do our best. We would provide an update once it is submitted, but it's really not easy for us to commit to something, and we like to do that as soon as possible, and we will update everybody once it's submitted. The good news is that this happens in a dialogue, so it's not just in a vacuum, so the submission is in a dialogue with the agency, and that's kind of what is important.

It's not easy for us to commit to something and we like to do that as soon as possible and we will update everybody once it's submitted.

Good day and also this happens in a dialogue. So it's not just in a vacuum. So the submission is in a dialogue with the agency and that's kind of act also is important.

And is it a similar question on the timeline for the OLED at our any other update we're going to get from the grammar.

Unidentified Analyst from Jones Research: A similar question on the timeline for the OLE data or any other updates we're going to get from the Azamir trial. So the OLD data is, the OLD is ongoing. So there's always the possibility of doing an interim analysis because it's an open-label extension study, but the OLD study is ongoing. It's just needed to provide additional safety data. So it's really like the focus is on that. Right, I'll go switch to the REDD program. Two questions.

Michael.

Uh huh.

So the old <unk> data is the oil these ongoing so theres always a possibility for doing an interim analysis because its open label extension study, but the <unk> study is ongoing is just needed to to to provide additional safety data. So it is really like the focus is on that.

Thanks.

Switching to the <unk> program.

Two questions one is.

Unidentified Analyst from Jones Research: One is, If you can provide us some kind of detail on the difference between your trial and a KDS trial, the reduction in the Even the placebo arm or the treatment arm is much pronounced in your trial. Does that mean the baseline characteristics were very different in the enrolled patient? And the second is you saw a quick early four-week, possibly a clinical benefit, but then it kind of waned away at the 12-week time point, so you think it might be a pharmacokinetics or a dosing issue. No, I think if I can start with the last part, there's not such a thing.

If you can.

Providers.

Detail on Joe the difference between.

<unk> trial <unk> trial.

The reduction in the.

Given the placebo arm of the treatment.

You announced a new trial does that mean, the baseline characteristics look very different in the enrolled patients.

Second is you saw a quick arty four week.

Possibly a clinical benefit, but then it kind of waned away at the 12 week time point.

The pharmacokinetics are a dosing issue.

Yeah.

No I think if I can start with the last part.

There is not such a thing actually the trial was really showing a.

Dr. Christopher Misling: Actually, the trial was really showing an extremely nice improvement score in the active arm, with over minus 12.9 in our analysis, which is extremely strong. And trophinotype showed only an improvement in the active arm of minus 5.1. So we showed a stronger signal in the active arm. What happened was, in our trial, this placebo also improved. And in the trophinotype, the placebo did not improve. So that is basically the difference.

Extremely nice improvement score in the active arm with over minus 12.9 in our analysis, which is extremely strong and to phenotype showed only an improvement in the active arm of minus 5.1. So we showed a stronger signal in the active arm.

What happened was in our trial the placebo also improved and in the trough phenotype. The placebo did not improve so that is basically is really the difference, though the standard aero. So the variability of discourse was much higher in our trial they needed to.

Dr. Christopher Misling: So the standard error, so the variability of the scores, was much higher in our trial than in the trophinotype trial. And we have laid out several factors why that is possible. And we now understand exactly what happened.

Phenotype trial, and we laid out several factors why that is possible and we now understand exactly what happened and we can factor that in in the explanation very very very nicely. So it's really like the the variability of the trials the noise if you like with <unk>.

Dr. Christopher Misling: And we can factor that in in the explanation very, very, very nicely. So it's really like the variability of the trial, the noise, if you like, was much higher in our trial. And let's not forget, we had a smaller study. We also had phase 2, phase 3.

A much high eight hour trial, and let's not forget we had a smaller study. We also had a phase two slush <unk> was not a pivotal study phase III and also we had just a two to one randomization with 60 patient six between the active arm.

Dr. Christopher Misling: It was not a pivotal study, phase 3. And also, we had just a 2 to 1 randomization with 60 patients or 62 in the active arm and 30 in the placebo arm. And these 30 patients, if a few of them are just basically very noisy, that could derail and increase the noise in the trial and increase the standard error, which we saw in our trial. So should we expect that rates to still be kind of one of the primary focuses for the company, and maybe one path forward would be to start a fresh pivotal trial with 180 patients, one-to-one randomized kind of the Acadia size trial? That is a very good point and it's exactly a possibility, and again, we would not do that without further regulatory input because we might get some feedback which could be very favorable, but indeed, that is something which could be done very easily. It's a 12-week study. It's not too long, and we have again a strong interest from the community given the heart strong interest in continuing to take the study drug and patients in red syndrome from our program Thank you again for taking the questions and congratulations to all.

<unk> 30 in the placebo arm and this 30 patients if a few of them are just basically very noisy that could derail it.

Increase the noise in the trial and increase the standard error, which we saw in our trial.

So should we expect that rates still being.

Kind of.

One of the primary focuses for the company and May be one path forward would be to start afresh pivotal trial with 180 patients one to one randomized kind of <unk> sized store that has a very good point and it's exactly a possibility and again, we would not do that however, without further.

We'll get regulatory input goes we might get some feedback which could be very favorable, but indeed that is.

Something which could be done very easily the 12 week studies not too long and we have again, a strong interest from the community given the heart the strong interest and to continue to stay on study drug and patients in Ret syndrome from our program has been now on this drug for over four years up to four years that.

It really shows very high.

Sticky.

Interest to keep our drug and not to switch to anything else in the meantime.

Understood. Thank you again for taking the questions and congratulations on all the.

Clint Tomlinson: Thank you. Looks like our next call comes from Tom Bishop with CI Research. Go ahead, Tom.

Thank you.

It looks like our next call comes from Tom Bishop with Bi research.

Go ahead, Tom can you hear me yes.

Yes go ahead.

Where do you stand with the FDA as far as all Simers goes.

Tom Bishop: Yes, go ahead. Good. Where do you stand with the FDA as far as Alzheimer's goes? I mean, I was really pleased with the news about the EMA. But what about the FDA? Yes, it's a great question.

Really pleased with the news about the EMA.

But are worried about the FDA.

Okay.

Great question.

Dr. Christopher Misling: We actually noticed that last night we saw the release from AZI, and the pickup of the antibodies for licanobab was relatively, I would say, muted. So we saw that in the last quarter they were not able to reach their target numbers of patients on the drug in the market, and they basically stated that they had reached a very limited amount of patients on the drug. This tells us that the antibodies indeed do not seem to be easy, well received in the community, or the procedures are very cumbersome, or the PET centers are not able to accommodate patients, or the MRI centers are not able to schedule patients at a time. So it's a combination of factors which I cannot really talk about but which seems to be really not an easy task.

We actually have noticed that last night, we sold the release from ASI and the pickup of the antibodies of Lee Carnival was relatively.

I would say a muted so we saw that in the last quarter.

We were not able to reach their target numbers of patients on drug in the market and he basically stated that they have reached a very limited amount of number of patients on the drug that tells us that the antibodies indeed.

Seem to be not easy.

Well received in the community or the procedures are very cumbersome or the the pet centers are not able to accommodate.

Patients are the MRI centers are not able to schedule at a time. So it's a combination of factors, which I cannot really talk about but seemed to be really not an easy task and this gives us actually probably an interesting position from a timing perspective to prepare now a dialogue with the agency to share our day.

Dr. Christopher Misling: And this gives us actually an interesting position from a timing perspective to prepare now a dialogue with the agency to share our data with the small molecule, which has the advantage of being easy, administrable, and does not have any challenging procedures. You don't need a PET study up front. You don't need an MRI study up front or during treatment, and you can just go to the physician and be assessed for Alzheimer's disease, and the physician will say take these capsules or pills and come back in a few weeks or months again. And so this is really a big advantage from our procedure.

<unk>.

With the small molecule, which has the advantage of being.

Easier administer bull does not have any challenging procedures, you don't need a pet study.

Franz you need you don't need a MRI study upfront or during the treatment.

And you can just go to the physician and be assessed and have ultimate disease and the physician will say.

Take this.

Capsules or pills and come back in a few weeks or months again and so this is really a big advantage from from our procedure. There is also no requirement to have a demonstrated level of a beta in the brain because in our study it was not required we measure.

Dr. Christopher Misling: There's also no requirement to have a demonstrated level of beta in the brain because, in our study, it was not required. We measured beta in the brain, but it was not an entry criteria. So the entire population of the Alzheimer's population in the world, including every region, would be basically the entire population would be something out of exosome 3, black carbazine, could be considered as a target population.

Are they better in the brain and it was not an entry criteria. So the entire population of the Ultima.

Population in the world, including.

Every region would be basically the entire population would be something on the exits and three black comes in could be consider as a target population, while the antibodies only can target patients with mci and a certain level or threshold of a bet on the brain and it turns out not.

Dr. Christopher Misling: While the antibodies only can target patients with MCI at a certain level or threshold of beta in the brain. And it turns out not all patients with Alzheimer's have that threshold, that high threshold of beta in the brain. So they would not be eligible for antibody treatment.

All patients with ultimate have debt thresholds that Hyatt threshold of a bet on the brain. So they would not be eligible for a antibody treatment. So that basically means that the available population in the alzheimer disease is much larger for black cognizant.

Dr. Christopher Misling: So that basically means that the available population in Alzheimer's disease is much larger for black carbazine to penetrate than for the antibodies. So this is a long winding answer. So we are proceeding with this dialogue. Do you plan, perhaps, to speak to the FDA? Soon, or are you scheduled to, or have you already made your case? You are playing up what I just said, and the timing could not be better.

To penetrate than for the antibodies. So this is a long winding answer so we are proceeding with this dialogue.

So.

Do you plan, perhaps to speak to the FDA soon or are you scheduled to or have you already two we're planning. Thank you case plays.

What I've, just said and the timing could not be better.

Dr. Christopher Misling: Okay, great. And as far as Rhett goes, what I sort of heard you say was, given that the data for A273 was even better than the drug that recently got approved, except for how the placebo went, is it possible that the FDA might just go ahead and encourage you to file for approval based on this data? We don't know, and everything's possible.

Okay, great and as far as rent goes what I sort of heard you say was given that the data for.

873 was even better than then the drug they recently got approved.

Except for how the placebo went.

Is it possible that the FDA might just go ahead and encourage you to file for approval.

Based on this data.

We don't know and everything is possible. That's why we said we want a reserved and analyze the data completely and then discuss this with the agency and that we take the next step from there so, but we cannot promise anything but again as I mentioned before these are very easy.

Dr. Christopher Misling: That's why we said we wanted to reserve and analyze the data completely and then discuss this with the agency, and then we would take the next steps from there. But we cannot promise anything. But again, as I mentioned before, there's a very easy way to address this as a backup plan to have just another study, a 12-week study, and put in place all the features which would not allow for a placebo response as we have seen in larger studies, similar size to trufinatide and also other features which can be included. How big was their study again? Pardon me? 12 weeks? How big was it, though?

Way to address this as a back up plan to have just another study a 12 week study and putting in place all the features which would not.

Which would not.

Allow for a placebo response as we have seen larger study similar sized retrofitted tide and also.

Other features which can be included.

I mean, we're sort of steady again.

Help me 12 week.

How big was it do one eight to 180 patients I think run about 180 patients in total so randomization 1990 active arm placebo equally.

Tom Bishop: Oh 180 patients, I think, around about 180 patients in total. So randomization 1990 active arm placebo equally random. Okay. The phase two study was half of this size with a caveat that we had only 30 patients in the placebo arm, and these measures are very noisy, as we have noticed, and so unless you get unblinded, maybe they are noisy, and they're just not measures that are perfect, and that's what we noticed, but there are ways to address it to avoid this noisiness, and now we can implement it.

Okay.

Phase II study was a phase II phase III study was after this size with the caveat that we had only 30 patients in the placebo arm and these measures are very noisy as we have noticed and so unless you get unblinded maybe.

They they are noisy and.

They're just not.

Measures, which are.

Which are perfect and that's that's what we've noticed that there are ways to address it to avoid this noise in this and now we can implement that.

Okay, well good speeds.

Dr. Christopher Misling: Okay, well, Godspeed. Thank you. So I don't see any other questions at this time, Dr. Muslin. Thank you. Again, this is exciting progress in the field relating to treating neurodegenerative diseases, and highlights the significant potential for our broad therapeutic portfolio and differentiated precision medicine platform to deliver easy access to and scalable treatment options, as demonstrated by the initiated process of marketing authorization application to the European Medicine Agency, EMA, for Blacamezine related to the treatment of Alzheimer's disease. We continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives with neurodegenerative, neurodevelopmental disorders, and schizophrenia.

Thank you.

Thank you.

So I don't see any other questions at this time mechanism.

Again this is exciting progress in the field relating to treating neuro degenerative diseases.

Delights, the significant potential for broad therapeutic portfolio and differentiated precision medicine platform to deliver easy access and scalable treatment option demonstrated by the initiated process of marketing authorization application to the European Medicine Agency EMA for Black Amazon really.

<unk> to the treatment of ultimate disease, we continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives living with neuro degenerative neurodevelopmental disorder and schizophrenia. Thank you.

Dr. Christopher Misling: Thank you. Thank you all for participating today. This concludes our conference. You may now disconnect. Goodbye.

Thank you all for participating today. This concludes our conference you may now disconnect.

Okay.

Goodbye.