Q2 2024 Anavex Life Sciences Corp Earnings Call
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com.
With us today is Dr. Christopher Misling, President and Chief Executive Officer, and Sandra Bernish, Principal Financial Officer.
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Before it 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 FCC.
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This includes without limitation, the companies forms 10K and 10Q, 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 limitation risks inherent in the development and or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals,
need an ability to obtain future capital and maintenance of intellectual property rights. And with that, I would like to turn the call over to Dr. Mislam.
Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our most recently reported financial results and to provide our quarterly business update.
We are encouraged by the very recently issued FDA guidance for early Alzheimer disease, which states that one cognitive measures alone, like others COK, could be a sufficient primary endpoint for early Alzheimer's disease.
We appreciate this new guidance and believe this opens another possible pathway for us to move forward in parallel to the initiated process of market authorization application to the European Medicine Agency, EMA, for black carmene for the treatment of Alzheimer disease, which are already underway.
Full data from the black carmesine
study in Alzheimer's disease, phase 2B-3, placebo-controlled clinical trial, will be published in an upcoming peer-reviewed journal. As well, analysis of RNA sequencing of the trial is underway, and interim data is expected by mid-20204.
These factors may include without limitation risks inherent in the development <unk> commercialization of potential products uncertainty in the results of clinical trials or regulatory approvals.
<unk> ability to obtain future capital and maintenance.
Concurrently, the Attention ID Open Label Extension trial is ongoing, and we expect to be able to share interim data in the second half of 2024.
The intellectual property rights and with that I would like to turn the call over to Dr. <unk>.
Thank you Clint and good morning, everyone. Thank.
Speaker Change: Thank you for being with US today to review, our most recently reported financial results and to provide our quarterly business update.
In Red Syndrome, continued positive real-world evidence feedback from Red Syndrome patients and caregivers
participating in the ongoing open label extension trial and compassionate use program for patients who participated in the excellence trial encourages us to continue our partnership with the red syndrome community and to proceed with a phase three 12 week efficacy study
Speaker Change: We are encouraged by the very recently issued FDA guidance for early ultimate disease, which states that one content measures alone like others caulk could be a sufficient primary endpoint for early ultimate disease.
Speaker Change: We appreciate this new guidance and believe this opens another positive pathway for us to move forward in parallel to the initiated process of market authorization application to the rupee in Medicine agency EMA for block commenting for the treatment of autoimmune disease, which is are already underway.
An educational presentation will be provided at the 2004 IRSF Red Syndrome Scientific Meeting taking place this year June 18 to 19, 2024.
Speaker Change: Full data from the block Compazine study in autoimmune disease phase II <unk> III placebo controlled clinical trial will be published in an upcoming peer review journal.
Regarding Parkinson disease, initiation of a Anavexasicine 3, phase 2B slash 3, six-month trial is expected in the second half of 2024.
Speaker Change: As well the analysis of RNA sequencing of the trial is underway and interim data is expected by mid 2024.
In prejudged X,
new specific translatable and objective biomarker data generated
with Anabex 273, supporting the initiation of the potentially pivotal underx 273 Phase 2-2-3 clinical trial will be presented at the 19th National Fragile Foundation Conference.
Speaker Change: Concurrently the attention at the open label extension trial is ongoing.
Speaker Change: And we expect to be able to share interim data in the second half of 2024.
Speaker Change: In Ret syndrome continued positive real world evidence feedback from Ret syndrome patients and caregivers participating in the ongoing open label extension trial and compassionate use program for patients who participated in the excellent trial encourages us to continue our partnership with the Ret syndrome.
taking place in July 25th to July 28th, 2004.
related to a new red disease,
We are also in preparation to initiate a potentially pivotal ANAX-273 phase 2 slash 3 trial.
With respect to ANAVEX-371, we are quite pleased to provide an update that the placebo-controlled phase two clinical trial of ANAVX-371 for the treatment of schizophrenia.
Speaker Change: Community and to proceed with a phase III 12 week efficacy study.
Speaker Change: And educational presentation will be provided at the 2024.
Speaker Change: Our S F Ret syndrome scientific meeting taking place this year doing 18 to 19 2024.
The study is well underway with the first cohort of schizophrenia patients being fully enrolled.
Speaker Change: Regarding parkinson disease initiation of <unk> phase II B slash three six months trial is expected in the second half of 2024.
We are also expecting further peer-reviewed clinical publications involving both ANAVEX 273 and ANAVEX 371.
Speaker Change: And Fedex <unk>.
And now I would like to direct the call to Sandra Bernish, principal financial officer of Annavex, for a financial summary of the recently reported quarter.
Speaker Change: Specific translatable and objective biomarker data generated with <unk> 273, supporting the initiation of the potentially pivotal on <unk> two <unk> phase II slash three clinical trial will be presented at the 19th National Fragile X Foundation <unk>.
Thank you, Christopher, and good morning to everyone. I'm pleased to share with you today our second quarter financial results for the 2024 fiscal year. Our cash position at March 31st was $139.4 million.
Speaker Change: France, taking place.
Speaker Change: In July 25th to July 28, 2024.
During the quarter, we utilize cash and cash equivalents of 11.7 million in operating activities. After taken into account, changes in non-cash working capital accounts.
Speaker Change: Related to our new rare disease.
Speaker Change: We are also in preparation to initiate a potentially pivotal unaffected 273 phase II <unk> trial.
At our current cash utilization rate, we believe we have cash runaway approximately four years.
Speaker Change: With respect to <unk> 371, we are quite pleased to provide an update that the placebo controlled phase II clinical trial of <unk> 371 for the treatment of schizophrenia.
During our most recent quarter, our general and administrative expenses were 2.8 million as compared to 2.6 million in the immediately preceding first quarter.
Speaker Change: The study is well underway with the first cohort of schizophrenia patients being fully enrolled.
Our research and development expenses for the quarter were 9.7 million, as compared to 8.7 million for the immediately preceding first quarter.
Speaker Change: We are also expecting further peer reviewed clinical publications involved involving both on the VIX 273, and <unk> 371.
And lastly, we are reporting a net loss of 10.5 million for the quarter or 13 cents per share. And thank you. Now back to you, Christopher.
Thank you, Sandra. This is an exciting time for the company, and we are 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.
Speaker Change: And now I would like to direct the call.
Speaker Change: Replenish principal financial officer of analytics for a financial summary of the recently reported quarter.
Replenish: Thank you Christopher and good morning to everyone.
Replenish: I'm pleased to share with you today, our second quarter financial results for the 2020 for fiscal year <unk>.
Thank you, Christopher. We'll now begin the Q&A session. If you have a question, raise your hand, or put it in the Q&A box. And it looks like our first call is coming from Schumet.
Replenish: Our cash position at March 31 was $139 4 million.
Speaker Change: During the quarter, we utilized cash and cash equivalents of $11 7 million and operating activities.
from Jones Research.
You should be live, shouldn't it?
Speaker Change: After taking into account.
Speaker Change: He is in noncash working capital accounts.
Yeah, congratulations on all the progress and
Speaker Change: And our current cash utilization rate, we believe we have cash runway approximately four years.
A few questions on the FDA guidance. It's oftentimes a bit qualitative and trying to understand, reach through the line when they're saying strong biomarker and strong statistical data to support the clinical outcome on the cognition fund.
Speaker Change: During our most recent quarter, our general and administrative expenses were $2 8 million as compared to $2 6 million in the immediately preceding first quarter.
Speaker Change: Our research and development expenses for the quarter were $9 7 million compared.
How do you really interpret that? When you're looking at Amelage in 42 over 40 ratio, the error bars when you compare with the company is just because of the cohort size is a little larger.
Speaker Change: About $8 7 million for the immediately preceding first quarter.
Speaker Change: And lastly, we are reporting a net loss of $10 5 million for the quarter or <unk> 13 per share.
How many patients was there and do you see these to be considered strong or
Speaker Change: Thank you and now now back to you Christopher.
Christopher: Thank you Sandra this is an exciting time for the company and we are very excited to be entering a new phase of the company's history with our biomarker driven precision medicine programs.
If D would ask for a larger trial, I'm curious about your process.
So the key background is that for the biomarker of abeta changes in placebo versus active arm,
Christopher: Now I'd like to turn the call back to Colin for Q&A.
Colin: Thank you Christopher.
we have to be reminded that the mechanism of our drug is not an antibody removing a better drug.
Colin: We will now begin the Q&A session. If you have a question raise your hand or put it in the Q&A box and.
Colin: It looks like our first call is coming.
but is an orally available once daily, easy to administer, and scalable drug. And has for that a lot of convenience features, which the antibodies don't have in addition to the fact that they are
Colin: Schmidt.
Schmidt: From Jones research.
Schmidt: You should be live Schmidt.
Colin: Yeah.
Schmidt: Okay relations on all the progress and.
having challenges with the black box warning which they have been given. So there's also a challenge from safety and repeated safety measures on MRI are required.
Schmidt: Few questions on the FDA guidance itself.
Schmidt: Cancel with qualitative and trying to understand reach to the line when.
Schmidt: When theyre things biomarker and strong statistical data to support the clinical.
Schmidt: Clinical outcome with the publishers.
Regarding the biomarker data of the A-Beta, we were intrigued
Schmidt: How do you really interpret that when you're looking at.
But on the other hand, not surprised that we saw a reduction of abeta in the brain measured by the plasma A-Beta-2-40 ratio, which is
Colin: And led to the vertical or the ratio.
Colin: Arrow bars, any compared with our company is just because of the cohort sizes larger.
Colin: How many patient work there and do you see these to be considered strong or.
the analogy of measuring a pet, a better level in the brain,
which is intuitively easier to understand because you are showing a decline in the brain.
Colin: If you would ask for a larger trial.
Colin: Okay.
but the A beta 40 to 40 ratio, which again is
Colin: So the key background is that for the biomarker of a better changes in placebo versus active arm.
representative of this fact of reduction of a beta in the brain is then measured in the plasma shows as an increase of this ratio
Colin: We have to be reminded that the mechanism of our drug is not a antibody removing a better.
favorably showing a decrease in the brain. So if the ratio goes up, that means a beta in the brain goes down. So since we don't target a beta directly,
Colin: Drug.
Colin: But it is an orally available once daily easy to administer and scalable druck and <unk> for that a lot of convenience features which the antibodies don't have.
with our drug, but have a more upstream mechanism of action. Again, we were intrigued and surprised to see in all patients, there was no sub-analysis in this analysis of the abeta ratio, showing a significant decline.
Colin: Addition to the fact that they are.
Colin: Having challenges with the.
Colin: Black box warning, which they have been given so there's also a challenge from safety and repeated safety measures on MRI.
So now it's a question of dialogue with the agency, how this will be interpretable as a biomarker. But I'd like to also point out we have a second question.
Colin: Regarding the biomarker data of the better we were intrigued by.
Colin: On the other and not surprised that we saw a reduction of a better in the brain measure.
strong biomarker, which probably even is stronger, specifically from a P-value perspective, which is the changes in the atrophy of the brain.
Colin: The plasma EBIT of $42 40 ratio, which is.
Colin: The analogy of measuring our pet a better level in the brain.
So in the pathology of the Alzheimer disease, there is a very well understood feature of shrinking of the brain over time.
Colin: Which is intuitively easy easier to understand because you were showing a decline in the brain.
Colin: The better 40 to 40 ratio, which again is representative of this fact of reduction of EBITDA in the brain is then measured in the plasma.
And this is intuitive. If the brain is shrinking, it's less active. It cannot have as good memory or activities of execution and function as the brain was not shrinking.
Colin: An increase of this ratio favorably showing a decrease in the brain. So if the ratio goes up that means the better in the brain goes down.
And we noticed in our trial a significant stopping of the shrinking of the brain with Anavex-273 la carmesine in the active arm compared to placebo.
Colin: So since we don't target EBITA directly.
Colin: With our drug but to have a more upstream mechanism of action.
Colin: Again, we were intrigued and surprised to see in all patients.
So the placebo arm continues to shrink the brain in the patients while they are on placebo.
Colin: Those sub analysis.
Colin: In this.
Colin: Analysis of the EBITDA ratio showing a significant decline.
which is standard of care, by the way, it's not placebo itself. It's including bonapidil, memantine. So all the data is always on top of standard of care, which is today approved, includes approved drugs.
Colin: So now it's a question of.
Colin: Our dialogue with the agency all of this will be interpretable as a biomarker.
And however, the active arm on black carmesine or a Vax2703 shows a
Colin: Like to also point out a second.
Colin: Strong biomarker, which probably even stronger.
significant separation from the placebo by not shrinking the brain any further or delaying the shrinking of the brain in many regions of the brain. And this exact data will be part of the publication which we're expecting.
Colin: Specifically from a P value perspective, which is the changes in the offer of the brain.
Colin: So in the pathology of the ultimate disease, there is a very well understood.
Colin: Feature of shrinking of the brain overtime.
So I think once this data comes out, I think then we can rediscuss
Colin: And this is intuitive if the brain is shrinking is less active.
the impact of that biomarker
Colin: Active connectors, good memory or.
in combination with the abeta biomarker. And again, with the abeta biomarker, I'd like to remind again, we did not target without our drug directly abeta. So it must be a downstream effect of the upstream feature of the Sigma 1 receptor, showing also the impact on the entire population in our trial.
Colin: Activities of execution and function as the brand was not shrinking.
Colin: And we noticed in our trials are significant stopping of the shrinking of the brain.
Colin: With <unk> two <unk> three like a common theme in the active arm.
These are truly encouraging data. You have quite a few catalysts coming up in the next probably three months. I'm trying to understand what would be the strategy when you go to FTA. Would you wait for the...
Colin: Compared to placebo. So the placebo arm continues to shrink the brain and the patients while they are on placebo.
Colin: Which is standard of care by the way both placebo itself, it's including the <unk> Memantine. So all the data is always on top of standard of care, which has today approved includes approved drugs.
open level extension on trial data to come out along with the publication and completion of the European filing and then approach to FDA with
Colin: And however, the active arm on block comments in order of exclusivity III chose.
The total data with biomarker and the long term or would you do before that, meet with a day before the long term extension for the data?
Colin: The consistent separation from the placebo by not shrinking the brain any product or delaying the shrinking of the brain in many regions of the brain and this exact data will be part of the publication which were expecting.
Yeah, so we really want to have the best impact, I would say, and you don't have a second chance for first impression, as they say.
Speaker Change: So I think once the data comes out I think that we can re discussed.
And certainly having data of the open label study, which is 96 weeks, probably would be favorable. However, we have not decided how to proceed on the timing exactly, but definitely this year.
Speaker Change: The impact of that biomarker.
Speaker Change: In combination with the a better biomarker and again with a better biomarker I'd like to win.
Colin: We did not target with our drug directly or better so it must be a downstream effect of the upstream feature of the Sigma one receptor.
But also we can do sensitive open label interim cuts. So there's a way to expedite the analysis of the open label study.
Colin: Drilling also the impact on the entire population in our trial.
That is truly helpful. Last question on if you can provide any guidance on the timeline around completion of the European file.
Colin: Indeed, a truly encouraging data.
Colin: Apple is coming up in the next probably three months.
Yep.
So we definitely want to expedite this and the teams are working really over time to put together the modules, which are many pages, a significant package.
Speaker Change: I'm trying to understand.
Colin: What would be the stock is either equal to or would you wait for the.
Colin:
Colin: Okay.
Colin: Open label <unk>.
Colin: And Sean trial data too.
We talk about a lot of documents.
Colin: Come out along with the publication of completion.
And they all have to be completely ready. Usually this takes time. Other companies going to the same process, need the same time.
Colin: Finally, as Dan approach to FDA.
Colin: Probably the VITAS, a biomarker or under long term or would you talk before that.
So we are not in a different situation like that. But we said we want to submit this year, and we are well on track to do that. So we will provide updated timing when we get closer to the finding time. But we are very good on time with that. So stay tuned.
Speaker Change: You're welcome.
Speaker Change: Yes, so we really want to have the best impact I would say.
Speaker Change: And you don't have a second chance for first impression as they say.
Dan: Certainly having data of the open label study, which is 96 weeks probably would be favorable. However, we have not decided how to proceed on the timing exactly but definitely this year, but also we can do since it's an open label interim cuts. So it is a way to.
Thank you and congratulations from all the progress.
Thank you.
Our next call is coming from RAM at H.C. Wainwright.
Can you hear me? Yep, perfect. Thank you.
Speaker Change: Expedite the analysis of the open label study.
Okay, with respect to the
Speaker Change: That is really helpful. Last question on if you can provide any comments on the timeline around.
regulatory process with the European authorities.
Can you give us a sense of A, when you expect
Speaker Change: The European filings.
Speaker Change: So we definitely want to expedite this and.
the MAA filing to be completed and B,
Speaker Change: The teams are working really.
how you anticipate the process to evolve with respect to the CHMP review, how and when they are likely to become involved in the review of the application, and what you understand to be the principal criteria they are going to use to evaluate the suitability of Blarkamacin for approval in the European Union. Thank you.
Speaker Change: Over time to put together the modules, which are many pages a significant package, we've talked about a lot of documents and there ought to be completely.
Speaker Change: Completely.
Speaker Change: It usually just takes time.
Speaker Change: Other companies.
Speaker Change: Going to the same processes. The same time. So we are not in a different situations like that but we said we want to submit this year and we are well on track to do that.
So we stated that just a minute ago that we are filing as soon as possible definitely this year.
Speaker Change: So we will provide updated timing when we get closer to the filing time, but.
And the team is really working overtime to put together a package, which has to be done in one submission.
Speaker Change: But we are very good on time with that so stay tuned.
Speaker Change: Thank you and congratulations on all the progress.
There's also interactions taking place with the EMA to be aligned on the technicalities. So that precedes these submission. We also...
Speaker Change: Thank you.
Speaker Change: Our next call as kind of program at H C. Wainwright.
Speaker Change: Branch should be like.
Speaker Change: Can you hear me.
Speaker Change: Perfect. Thank you.
are
Speaker Change: Okay.
Sorry, what was the second question?
Speaker Change: With respect to the inventory process with the European authorities can you give us a sense of when you expect the MMA the MAA filing to be completed and B. How you anticipate the process to evolve with respect to the C. H M T review.
The involvement of the CHMP, that review committee that typically looks at drug candidates that are submitted to the EMA for approval and renders a positive or a negative opinion prior to an approval decision being taken. Just wanted to know when you expect the CHMP to get involved in the review of the Blarcamassine MAA and what criteria you expect them to use to determine what their opinion should be. Right.
Speaker Change: How and when they are likely to become involved in the review of the application and what you understand to be the principal criteria. They are going to use to evaluate the suitability of block canvassing for approval in the European Union.
Thank you for reminding. So the procedure of the submission involves a review of the package before it gets submitted. And it's a very healthy procedure because it allows exactly this intelligence to feedback to be received.
Speaker Change: Thank you.
Speaker Change: So we stated that so just a minute ago that we are filing as soon as possible definitely this year.
Speaker Change: And the team is really working over time to put together a package, which has to be done in one submission there.
So we expect this to take place.
to give you a sense of the level of interest.
Speaker Change: It is also interactions taking place with the EMA to be aligned on the technicalities. So that proceeds these submit.
We noted before that the reason we submitted to the EMA was not because we thought it would be a good idea, but because we shared
Speaker Change: Submission.
Speaker Change: We also.
Speaker Change: Our.
the majority of the data with the EMA beforehand and asked for their
Speaker Change: Sorry, what was the second question.
Speaker Change: The involvement of the CAH empty that review committee that typically looks at.
the input and their feedback and their response was
Speaker Change: Drug candidates that are subjected submitted to the EMA for approval and that renders a positive or a negative opinion prior to an approval decision being taken just wanted to know when do you expect to see HMP to get involved in the review of the block kind of seen MAA and what criteria are you.
unambiguous to request to immediately file a submission.
So we, of course, hope that this initial feedback will continue to be the case down the road. And right now we have no belief why wouldn't.
but that is of course up to the review. So we are coming in here not that we push, but we were pulled into the submission, given probably the unmet need in Europe , and also the fact that the European Union has not MRI, a pet centers in all places,
Speaker Change: I expect them to use to determine what their opinion should be right.
Speaker Change: Thank you for reminding.
Speaker Change: The procedure of the submission involves a.
Speaker Change: Review of the package before it gets submitted and it's a very healthy procedure because it allows exactly this intelligence of feedback to be received.
in the countries of the European Union, like in certain countries, for example, like Hungary or Poland or Romania, there are not enough MRI centers, which would probably be needed for a antibody given its safety profile.
Speaker Change: So we expect this to take place.
Speaker Change: To give you a sense of the level of interest.
Speaker Change: We noted before that the reason we submitted to the EMA was not because we thought it would be a good idea, but because we shared.
So that's the best we can say at this point.
And with respect to 371,
Speaker Change: The.
just wanted to, A, get a sense of
Speaker Change: Majority of the data with the EMA beforehand and us for there.
how you expect to monitor the efficacy profile of this compound in schizophrenia, if you regard, for example, certain domains of the PANSS to be the most appropriate efficacy measures, as well as
Speaker Change: Input and their feedback and their response was on.
Speaker Change: And ambiguous to request to immediately file.
Speaker Change: A submission so we of course hope that this initial feedback will continues to be the case down the road.
the extent to which you expect 371 to be differentiated from existing anti-schizophrenic medications and what you expect the principal areas of differentiation to be.
Speaker Change: And right now we have no belief why wouldnt, but that is of course up to the review.
Speaker Change: We are coming in here and not that we pushed but we will put into the submission.
For example, is it safety and tolerability more so than the efficacy? Or do you expect on both the safety as well as the efficacy fronts, this drug candidate to demonstrate a differentiated profile versus currently marketed, for example, atypical antipsychotic medications?
Speaker Change: Given probably the unmet need in Europe and also the fact that the European Union.
Speaker Change: <unk> has not MRI of pet centers in all cases.
Speaker Change: In the countries of the European Union like in certain countries for example, like Unreal Poland.
Yeah, I think it's exactly as you stated. It could be a really both.
Speaker Change: Not enough MRI centers, which would probably be needed for a antibody given its safety profile.
And if you look at the landscape of drug approval, you want to always be better than what is out there on the market.
Speaker Change: That's the best we can say at this point.
So if you're able to show that the safety has a better feature, a better profile, and also translate into stronger, more meaningful, efficacy, both on the positive as well as the negative,
Speaker Change: Okay, and then with respect to $3 71.
Speaker Change: Wanted to a get a sense of how you expect it to.
Speaker Change: Monitor the efficacy profile of this compound in schizophrenia.
domains of schizophrenia, then this would be extremely valuable and helpful.
Speaker Change: If you regard for example, certain domains of the pan out to be the most appropriate.
Speaker Change: You can see measures as well as the extent to which you expect $3 71 to be differentiated from existing anti schizophrenic medications and what you expect the principal areas of differentiation to <unk> for example.
We also want to point out in this study, we are focusing on EG ERP as a considered
surrogate biomarker of schizophrenia
So we are excited about finding out how the drug interacts in that regard.
Speaker Change: Safety and Tolerability.
And it's a very elegant, non-invasive methodology to identify that.
Speaker Change: More so than the efficacy or do you expect on both the safety as well as the efficacy fronts. This drug candidate to demonstrate a differentiated profile versus currently marketed for example, atypical antipsychotic medications.
But we also have included the standard PAN score in addition to this EG ERP. So we might learn something about the effect of our drug in the study in those regard, which would then allow us to decide how to proceed with this drug in schizophrenia.
Speaker Change: The other thing is <unk>.
Speaker Change: <unk> stated it could be a really both.
Speaker Change: And if you look at that.
Speaker Change: Oh and approvals you want to OLED.
And then the last question is sort of a combination of a strategic and financial query.
Speaker Change: Okay.
Speaker Change: Okay.
Let's say hypothetically that the EMA agrees that Blarcamesine is approvable for treatment of Alzheimer's disease in the European Union. At that juncture, strategically, what do you expect
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Has a better feature a better profile and also translate into stronger more meaningful efficacy both on the positive as well as the negative.
your preferred strategy to be in terms of whether or not you elect to undertake
Speaker Change: Domains of schizophrenia, then this will be extremely.
independent self-commercialization activities in Europe or whether you at that point would look to identify a partner. And does your cash burn guidance of runway for the next four years?
Speaker Change: Valuable and helpful.
Speaker Change: We also want to point out in this study we are focusing on EG ERP is a considered.
Speaker Change: Target biomarker of schizophrenia. So we're excited about finding out how the drug interacts in that regard.
take into account any pre-launch activity related expenses related to blarcamesine for treatment of Alzheimer's disease in Europe , or are you assuming that if you get an MAA approval, that you will look to identify a partner with which to launch the drug in Europe ? Thank you.
Speaker Change: Very elegant noninvasive methodologies to identify that but we also have included the standard.
Speaker Change: <unk> score in addition to the <unk>. So you might learn something about the effect of our drug in this study in those regard which.
Thank you for the question. So what we try to decide when it comes to that point is what creates most value for shareholders.
Speaker Change: Would then allow us to decide how to proceed with this broad and schizophrenia.
So if the most value is created by
finding a partner and who has the expertise and the bandwidth and the strength of executing and maximizing sales of the drug black carmazine for Alzheimer.
Speaker Change: And then the last question, it's sort of a combination of strategic and financial query.
Speaker Change: Let's say hypothetically that the EMEA agrees that block haven't seen is approvable for treatment for Alzheimer's disease in the European Union.
with giving us
the appropriate incentive to do so with the upfront payment, with milestone payments and royalties, that would be probably the choice. If, however, it is not the case, then there are certain combinations of such features where we could also consider a split
Speaker Change: That juncture strategically what do you expect.
Speaker Change: Your preferred strategy to be in terms of whether or not you elect to undertake independent self commercialization activities in Europe or whether you at that point toward look to identify a partner and does your cash burn guidance of a runway for the next four years.
ability to market the drug, which could also actually be beneficial for the company and shareholders because we might retain more upside down the road.
Speaker Change: Taking to account any prelaunch activities and related expenses related.
So this is really a decision made at the point in time when we're there to maximum shoulder value. On the other point, you asked about the...
Speaker Change: Related to block kind of thing for treatment of Alzheimer's disease in Europe or are you assuming that.
Speaker Change: If you get them MAA MAA approval, if you will look to identify a partner with which to launch the drug in Europe. Thank you.
cash utilization rate. Right now, we are not including any marketing expenses. And it's also not necessary because if it comes to a approval, you would have the ability to raise funds, non-diluited fund with debt funding and financing and these sort of, which would not dilute current shareholders. So you would not need to have that money in equity, a value. if you would come to the point that you need to pay expenses for marketing entry for that reason.
Speaker Change: Thank you for the question so what we try to decide when it comes to that point is what creates most value for shareholders. So it is the most value is created by finding a partner.
Speaker Change: And who has the expertise and the bandwidth and the strength of executing and maximizing sales of the drug that come and visit for ultimate.
Speaker Change: With giving us the appropriate incentive to do so with the upfront payment with milestone payments and royalties that would be probably the choice. If however, it is not the case then there are certain combinations of such features where we could also consider a split.
So we would be in a position to leverage the balance sheet without diluting existing shareholders.
Thank you for all the clarity and congrats again on all the progress.
Thank you.
Thank you, Bram.
Speaker Change: Our ability to market the.
Next question comes from Tom Bishop at VI Research.
Speaker Change: Which could also actually be beneficial for the company and shareholders, because we might retain them upside down the road.
Tom, you should be live.
Speaker Change: So this is really a decision made at the point in time, when we are there to maximize shareholder value on the other point you asked about.
I think you're muted, Tom.
Okay. Perfect. Can you hear me? Yep, you're good. Thank you.
Okay. I wasn't clear about this comment about the first cohort of schizophrenia being fully enrolled. And is this a 30-day trial? So would data presumably be forthcoming?
Speaker Change: Cash utilization rate right now, we are not including any marketing.
Speaker Change: Expenses, and it's also not necessary because.
Speaker Change: Comes to a approval you would have the ability to raise funds non dilutive fund with debt funding and financing.
you know, in H2, at least.
So we have to finish the trial so it consists of several cohorts.
Speaker Change: These sort of which would not arguing dilute current shareholders. So you would not need to have that money in equity available. If you would come to the point that you need to pay expenses for marketing entry.
in several parts.
So this was the first cohort in first part. And again, I want to point out this is a testament of the execution of the team which has done this so quickly. And again, we are ahead of time because we...
We are
anticipating starting the trial actually in this quarter, and we ended up starting the trial in the previous quarter, and now already have enrolled the first cohort. So it's very encouraging. I would leave the analysis, and when the study's finished, when we get closer to that point to announce that,
But we are very encouraged so far about the speed and the process of the study.
Are these different cohorts, what are they targeting and how long does the trial last in terms of dosing?
So the two-corot
In two parts, the first part is just identifying the doses of what is the best dose for the schizophrenia patients. So it's an ascending dose escalation part. And the second part is then at the...
optimal dose, if you like, a longer study of almost 30 days. So that is the second part. So we are right now in the first part.
Speaker Change: What influenced part and I cannot <unk> pointed out as a testament of the execution of the team.
Okay. And it's good to hear about the phase three, red,
Speaker Change: Which has done this so quickly and again we are ahead of time, because we are there.
trial. What can you tell us about the timing and the number of patients and I guess it's going to be 50-50 this time with placebo?
Speaker Change: Uhm anticipating starting to try it actually in this Porter and we ended up stopping the trial and the previous quarter an hour.
Can you tell us more about the trial? Right. So we really think that with Red Syndrome, we have really a good chance of...
Speaker Change: And he has enrolled to first go hot so it's very encouraging out.
Speaker Change: The analysis and when the study is finished when we get closer to that point to announce that but we are very encouraged so far about the speed and the process of the study.
what we referred to learn our lessons from the previous trial, where we really were only impacted by a very high placebo effect, and that was contributed among others, as you pointed out, to the two-to-one randomization, which gave the...
Speaker Change: Are these different cohorts, what are they targeting and and how long does the triangle last in terms of dose.
sense of a participating family to think that
Speaker Change: So there are two cohorts two parts. The first part is just identifying the doses of what is the best those four.
So 2 to 1 means that two chances are higher to be on active arm.
and randomizing only a small portion, one-third with placebo. So 60 patients ended up in the active arm and 30 into placebo.
Speaker Change: Could you repeat your patience so it said.
Speaker Change: Dose escalation part and the second part is <unk>.
But because of that, people thought or had the impression or the
Speaker Change: Optimal dose if you're like a longer study of almost 30 days. So that is the second part. So we have right now in the first part.
certainly the aspiration to have a higher chance of being in the active arm and that leads to
Speaker Change: Okay.
For those who are on placebo and are completely blinded, so don't know if they get
Speaker Change: Uhm.
Speaker Change: It's good to hear about the phase III red.
Speaker Change: <unk>, what can you tell us about the timing and the number of patience and I guess, it's gonna be 50, 50, this time with placebo.
the placebo or the active arm, to suspect or hope that they are in the active arm psychologically. So that's what is this bias most likely. So to avoid this, we would have a 50-50 randomization one-to-one so that there is no anticipated ability to expect...
Speaker Change: Can you tell us more about the trial right so be really think that with redfin Jerome.
Jerome: Yeah, that's really a good chance of.
Speaker Change: What would be referred to learn our lessons from the previous trial.
that to be in the active arm and triggering a placebo effect in the placebo arm.
Speaker Change: We really were only impacted by a very high placebo effect.
So that would be one thing. The other part is there also features to reduce placebo response by features of the trial, which are specific to technicalities. And then we also would do a larger study. It turned out that indeed the measurements are volatile, and only a few participants in the placebo arm could basically noise, close noise of the signal to be not significant. And that's what we observed. Thank you.
Speaker Change: And that was contributed among others as you pointed out would be 221, <unk>, which gives the sense of participating family to think that 2221 means that to Charles higher to be an active arm and.
Speaker Change: Randomizing only a small portion one third placebo. So 60 patient ended up in the active arm and 30 in the placebo.
Speaker Change: Because of that people thought or have depression or two.
So there was a very good trend and directional improvement, but we have to now make sure that the signal is strong enough to be significant, and that's the ability to do that. And the timing is,
Speaker Change: Especially the aspiration to have a higher chance of being in the active form.
Speaker Change: For those who are unplug stable.
Speaker Change: Completely blinded.
Speaker Change: Don't know if they get the placebo all the <unk> to suspect of hope that they are in the active army psychologically. So that's what's is this bias most likely so to avoid this we would have a 50 50 <unk> so that there's no anticipated ability to it.
We will provide update when we get closer, but the community is receptive to this. We are engaging with the community as we speak.
And also we mentioned that we are presenting at the conference in June in Colorado, as a matter of fact, to connect with the community about the next steps of this trial.
Speaker Change: <unk> to be in the act of farm and trigger.
And you don't quite yet know the number in the trial, which would affect how long it takes to get a
Speaker Change: A placebo effect in the placebo arm, so that would be one thing the other parties.
So the good news is that it's a relatively short trial. It's 12 weeks, so it's not too long. It can be done relatively timely.
Speaker Change: Just to reduce placebo response by features of the trial, which are specific to technicalities and then we also do a larger study it turned out that indeed, the the <unk>.
because the matter of fact is it's a not long tribe to begin with. And if there is, again, ability to scale this up and there's strong interest in an alternative...
Speaker Change: Measurements are volatile and only a few participants in the placebo arm.
Speaker Change: <unk> noise how's the noise of the of the signal to be not Smith, and that's what we observed.
marketed drug to Red Syndrome patients, this could help actually accelerate this trial to start and to kick off. Again, we will provide update as we know more.
Speaker Change: So there was a very good trend interactional improvement that we have to now make sure that the signal is strong enough to be significant and that's the ability to do that and the timing is.
Okay, can you remind us of the fragile X data to date? Is it just phase one kind of safety data and food data or is it
Speaker Change: We will provide update when we get closer but to communities receptive to this we are engaging with community as we speak and so we've mentioned that'd be presenting at the conference in June Colorado in a matter of fact too connect with a community about the next steps of this trial.
Or do I forget kind of some trial results we've gotten that you're considering moving to Phase 2B3 trial? Which indication? Sorry, I missed that. Fragile X. Yeah.
So this is very intriguing data. It's a biomarker, which is measurable both in patients, in humans, as well as in animals. And it's correlating very clearly, it has been published, to the pathology of fragile X or to showing a reduction of the pathology of fragile X.
Speaker Change: Okay, and you don't quite yet no the the number in the trial.
Speaker Change: Affect how long it takes to.
Speaker Change: Here.
Speaker Change: <unk>. So the good news is that it's a relatively short trial. It's 12 weeks. So it's not too long it can be done relatively timely.
And this will be presented for the first time at the conference in July . And we're very excited about it because it strengthens the...
Speaker Change: Because the matter of fact is it's not long tried to begin with and if there is again ability to scale. This up and this strong interest in in an alternative marketed dry tourette syndrome patients this could help actually and accelerate.
First of all, the evidence that Fragilex is an extremely good indication for black hamesine for ANWX273, but also it would give us in a clinical trial a biomarker, which is so important in CNS,
Speaker Change: This trial to start and to kick off.
Speaker Change: <unk> provide update S b and we know more.
which is hard to find biomarkers of apatology. So these are the two reasons why we're very excited about this presentation coming up.
Speaker Change: Okay can you remind us of the fragile X data to date is it just phase one kind of safety data and food data or is it.
So you could move into a potentially pivotal phase 2B3 trial just based on your biomarker data to date? Is it?
Speaker Change:
Speaker Change: Do I forget kind of <unk> trial results, we've gotten that you're considering moving to face to be <unk> <unk>.
Yeah, so that biomarker data we presented will also, we also, we have to also appreciate that there are physicians,
Speaker Change: <unk> indications, sorry, I missed it fragile X. Yeah. So this is very intriguing data as a biomarker, which is measurable bows in mmm impatience and humans.
patients, advocates group, who want to learn why would you, you know, why want you be part of a trial. And this information would give somebody that information to say, to be excited about being part of a trial because of the fact that it would define the chances of being beneficial to a patient.
Speaker Change: As well as in animals, and it's correlating very clearly it has been published to the pathology of Friday X or two showing a reduction of the pathology of <unk> and this will be presented for the first time at the conference.
Speaker Change: In July and we're very excited about it because it strengthens the first of all the evidence that <unk> is extremely good indication for black <unk>, but also it would give us in the clinical trial a biomarker.
in real world, and that's what this biomarker data would be to get the excitement in the community to also then have a smooth enrollment and trial execution, which is important.
Okay, finally, I just wanted to ask, you know, I worry about, I never thought we'd see stock, the stock under five again, the loan four. And I'm wondering if this could be concerned about the delay and the peer reviewed.
Speaker Change: Which is so important and C. N S. We just have to find biomarkers of a pathology. So these are the two reasons why we're very excited about this presentation coming up.
Speaker Change: So you can move into it.
article that we've been anticipating for so long and possibly even the lack of any insider buying. I mean, is there something preventing legally...
Speaker Change: Essentially pivotal phase two b three trial just based on your biomarker data date is.
Speaker Change: Is it.
Speaker Change: Yeah. So that biomarker data will presented will also we also we have to also appreciate that they are physicians patients advocacy group you want to learn why would you you know.
the company from doing insider buying. And if not, I would highly encourage it to
to show some faith here. Yeah, I appreciate the feedback. We are, of course, not happy about it either, but we have to also be aware that the whole market is in challenging positions. But the fortunate thing for us is that we have really enough cash without any debt.
Speaker Change: I want to be.
Speaker Change: And this is <unk>.
Speaker Change: Somebody that information to <unk>.
Speaker Change: About uhm.
We have a very good team which can execute
Speaker Change: It would be fine.
We are also hired additional team members, and we're expanding in our execution of trials, which we pointed out also today. And we are really excited and moving forward. So that's the part we can do, and that's what we will do. So it would be futile to comment on the stock market.
Speaker Change: Being beneficial to the preferred patient.
Speaker Change: In in the World and that's what <unk> data will.
Speaker Change: Would be to get the the excitement in the community to also then have.
Speaker Change: Smooth enrollment and tried execution, which is important.
Speaker Change: Okay. Finally, I just wanted to ask him I worry about I never thought we'd see stark stock under five again.
Oh, I mean, is there any chance of some insight of buying? Is there some...
Speaker Change: Four and I'm wondering if this could be concerned about the delay in the peer reviewed.
The lawyer is telling you you can't do. Every director is, insider is the chance to buy it. When we have a window, we have to check if we have a window. If we do have a window, this is a choice for every board member or insider to do.
Speaker Change: Article that we've been anticipating for so long and possibly even the lack of any inside you're buying I mean, there's there's something.
Speaker Change: Legally.
Thank you. I was just wondering if the window is now closed, and that's why we're not seeing. It's right now closed, but it could open, so we will see.
Speaker Change: Because the company from doing insider buying and if not I would highly encourage it.
Speaker Change: Some face here.
Speaker Change: <unk> the feedback we are of course, not happy about it either but it's we have to also be aware that the whole market is is in challenging position, but the unfortunate thing for us is that we have really enough cash without any debt.
All right, thank you. Thank you.
Looks like that's all the questions today, Dr. Ms. Lin?
Thank you. And in closing, we remain committed to the development of our programs within neurodegenerative, neurodevelopmental, and neuropsychiatric disorders.
Speaker Change: We have a very good team.
Speaker Change: Which can execute.
Speaker Change: We also hired additional team members and we're very we're expanding our execution of trials, which I'll be putting it out.
which could further expand our portfolio of transformative investigational therapies
utilizing our differentiated precision medicine platform to deliver easy access and scalable treatment options for brain disorders.
Speaker Change: And we're really excited and moving forward and so that's <unk> and that's what we will do so it is not it would be futile to comment on on on the stock market.
We continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patient lives living with these devastating conditions. Thank you very much.
Speaker Change: Oh, I mean is there a chance to some instead of buying a <unk>.
Speaker Change: Cause allergic to tell me that you can't do that.
Speaker Change: Every director is insider as the transfer to bite when we have a window we have to check if we have a window. If we do we have a window. This is a choice for every <unk>.
Great. Thank you, ladies and gentlemen. That concludes today's conference call. We appreciate your participation. You're now welcome to disconnect.
Speaker Change: Thank you I was just wondering if the window is now closed and that's why.
Speaker Change: Right now close but it could open so we will see.
Speaker Change: Alright, thank you.
Speaker Change: Thank you.
Speaker Change: It looks like that's all the questions today Sir.
Speaker Change: Thank you and in closing we remain committed to the development of our programs within your degenerative Neurodevelopmental in Europe psychiatric disorders, which could further expand our first one your transformative investigational therapies utilizing our.
Speaker Change: Differentiated precision medicine, <unk> form to deliver easy access and scalable treatment options for brain disorders, we continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patient lives living with this condition.
Speaker Change: Thank you very much.
Speaker Change: Alright. Thank you made a gentleman that concludes today's conference call. We appreciate your participation you're now welcome to disconnect.