Q3 2025 Anavex Life Sciences Corp Earnings Call
Good morning and welcome to the end of X Life Sciences. Fiscal 2025 third quarter conference. Call, my name is Clint Tomlinson, and I will be your host for today's call at this time, all participants are in listen-only mode. And later, we will conduct a question and answer session before or during the session. We'd like to ask a question, please use the Q&A box or raise your hand.
Please note this conference is being recorded and the call will be available on an ofx website at www.anx.com later today.
With us today is Dr. Christopher misting president and chief executive officer and Senator bonish Principal Financial Officer.
Before we begin, please note that this conference call is being recorded.
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, which include, without limitation, the company's Forms 10-K and 10-Q. These documents identify 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, the need and ability to obtain future capital, and maintenance of intellectual property.
Rights with that. I'd like to turn the call over to Dr. Missing.
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,
Our development of non-invasive targeted upstream compounds continues to advance.
Particularly in the context of Alzheimer disease and schizophrenia.
Clinical feedback highlights the importance of orally administered Therapies.
That are both accessible and effective.
At the recent also Association International Conference a AIC 2025.
We presented open label. Extension data for black hazine, which demonstrated continued clinically meaningful benefit in early stage of Summer patients.
Further validating its therapeutic potential.
In June 2012, a survey of ultimate disease stakeholders from European Union member states on current and made needs in Alzheimer care was conducted.
There's a clear acknowledgment that oral therapies would, quote, "facilitate things," quote, for many countries and be much more accessible for the respective healthcare systems.
Potentially, requiring less extensive monitoring and complex Administration compared to injectable monoclonal antibodies.
Sector in potential broader Market, penetration.
At the end of July, anex was honored to be a part of the program at the 2025 Altima Association International Conference AIC in Toronto.
The sharing of knowledge at these Central events is important to help Advance dimensional science to better support the millions of individuals families and communities impacted by ultimate disease.
At the AIC 20 25 conference. We were pleased to present the latest findings for black Army.
The data represented by Marvin. Sabak professor of Neurology and chairman of The Advisory Board of anex.
The data showed that blackham is intro to the patients, continue to accrue benefit through up to 4 years.
As measured by the prespecified clinical endpoints others, cock 13, and adcs ADL respectively.
Further presentations at the AIC, 2025 conference featured, prespecified, Precision medicine face to be slash 348 week, adex 273 800 to 4, double blind, clinical trial, data or black camazine, confirming the Upstream mechanism of blackham, restoring impaired autophagy as an early event, preceding amloid, beta and towel.
Hello. I would like to direct the call to Sandra berneche Principal Financial Officer of an effect for financial summary of the recently reported quarter.
Thank you so much, Christopher, and good morning to everyone on the call.
I am pleased to share with you today our third quarter financial results for our 2025 fiscal year.
Our cash position on June 30th was $101.2 million, and we had no debt.
During the quarter, we utilized cash and cash equivalents of $12.5 million in operating activities after taking into account changes in non-cash working capital accounts.
And as of the quarter end, we anticipate that the current adjusted cash utilization rate and range and approximate runway of more than 3 years.
Our research and development expenses for the quarter were 10 million dollars as compared to 1, 1. 8 4.
General and administrative expenses. Were 4.5 million as compared to 2.8 million for the comparable quarter of last year.
Compared to the same quarter of fiscal 2024 an increase in non-cash compensation. Charges was offset by a decrease in overall cash operating expenses so that the completion of a large manufacturing campaign of what our feminine.
To support execution and potential commercial Readiness, as we advance our therapeutic pipeline.
Summary we have focused on continuing to advance our Precision medicine compounds. We're excited to be potentially making a difference for individuals suffering from these diseases.
By presenting a scalable treatment alternative alongside the ease of oral Administration. I would now like to turn the call back to Clint for Q&A.
Thank you, Christopher.
Uh,
for our first.
Uh, question today. Uh, it will be from
Roy from Jones research.
Hi Clint. Thanks, um, hi Christopher. Um,
Quick question on the congrats, on the 4-year data.
Trying to understand uh, the graph itself. Could you help us explain? If the delayed start patients? Those were the ones from the placebo arm of the randomized trial.
and just, uh, the nature of the curve between the cock 13 readout and the ADL
The cock 13 doesn't separate until 96 weeks. Like that's like 2 years, um, versus ADL. Is there any specific thing that's going on there?
So it's a good question so you're referring to the 4-year open label extension data. Yes, let me. Yeah. So let me quickly explain again, what is done?
The patients are randomized at the beginning of the trial to either receive the placebo or the active arm.
Those patients who then finish the 48 weeks will get like a museum, all of them. So those patients who started like Karin, but they were blinded to it, that is no also State blinded.
that when they received Blackham, if they were
Receiving black hazine in the previous 48 weeks.
And they are called the continued black cozzine or early start group.
Those patients who, after they had placebo because they were randomized to placebo in the first 34 weeks, did not receive either black car museum.
And what we now look at is the
Trajectory of the 2 arms, the early start good, which had black comes in since day 1 and those, what we call late start Group which had black Kareem after the placebo control part. And what we find is that those patients
Who received the drug later after possible? First, they do not catch up to the benefit of those patients who had black cozzine.
From day one in the previous 48 weeks, and that indicates that if you have a disease, you want to not be getting it too late because you will not get the full benefit of the drug.
And the same applies for both cognition. As I've talked 13 and activities of daily living or function. Edcs ADL.
What we noticed was because of coid though there was not a perfect transition, from the end of the trial of 48 weeks into the open label extension, because sites were shut down.
And so the patient will just barely be able to measure the last measure of 48 weeks, but the open label was not accessible until, in some cases, a year later.
But those patients, eventually then joined. And what we found was that, we could basically separate 2 groups, those patients, which were not impacted by coid, so, to speak by this, um,
Uh, keep the cognition and function, uh, consistently better and.
to ask the question about this difference between uh, others Cog 13 and, um, ADL I think because of these
Um, others Cog. 13 is more sensitive to immediate actions in ADLs has a bit of maybe a, um, latency. The ADL seems to be more smooth in the trajectory than the others Co 13. So, the adex cop 13 is just more sensitive possibly to these changes, which are just described and the description in the conference with the graph.
On the slide shows clearly that those patients who were not interrupted or had a short Interruption they in the other scope 13. They had a clearly better outcome in the active arm than those who had a Interruption. What I just basically said um I a minute ago uh a trust that helps to explain the difference know that was
Super helpful. Thank you. Um,
Were the patients at the beginning of the open-label extension restaged? Um, but they still mild.
Stage patients or some of them progress to moderate.
Uh, so certainly, some have, uh, advanced, especially the placebo ones have advanced. But we kept all the patients, which was voluntary or in the trial, irrespective of how they advanced or if they had advanced to a more severe, uh, form of dementia. So both were, um, all were allowed to continue, um, and the majority did.
Clint Tomlinson: Good morning and welcome to the ANAVEX Life Sciences Corp. Fiscal 2025 Third Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. Before or during the session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note this conference is being recorded, and the call will be available on ANAVEX's website at www.anavex.com later today. With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer. Before we begin, please note that on 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.
But they were not re-stage for 2 SS. If they are still mild,
Add or moderate. Uh, there was no need to because they were eligible to continue to stay on study drugs so irrespective of their staging. Does it make sense? So it's not it's not taking away the ability to continue to stay on the study drug. Now, I was wondering if your drug could even be applicable to the moderate stage patient. So we have seen that actually in the face to be uh Phase 2, a study, which was published 2020 that patients with uh mild to moderate. So more advanced stage also benefited from black Kareem. So in a way, we have confirmed a broader therapeutic window for not only for our early ultimate disease but also for mild to moderate
1 last question, any guy?
Clint Tomlinson: We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's Forms 10-K and 10-Q, which identify 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 and ability to obtain future capital, and maintenance of intellectual property rights. With that, I would like to turn the call over to Dr. Missling.
Uh, guidance on the um, EMA. Um
Review or commentary back.
In.
So we stated that we would not uh provide comments until the uh final feedback of uh review is completed. And we we we speak to that but we excited about the progress.
Um, is that a 10-month review? Could you guide us? Help us with understanding the timeline, uh, filed in.
November last year.
Christopher Missling: 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. Our development of non-invasive targeted upstream compounds continues to advance, particularly in the context of Alzheimer's disease and schizophrenia. Clinical feedback highlights the importance of orally administered therapies that are both accessible and effective. At the recent Alzheimer's Association International Conference, AAIC 2025, we presented open-label extension data for blarcamesine, which demonstrated continued clinically meaningful benefit in early-stage Alzheimer's patients, further validating its therapeutic potential. In June 2025, a survey of Alzheimer's disease stakeholders from European Union member states on current unmet needs in Alzheimer's care was conducted.
So it was filed in November last year, was accepted in December last year. There's a plus,
Minus, uh, time frame, and Depends also a little bit on, uh, variables which are sometimes. Um, not, I cannot be anticipated. So, we estimate that first quarter of next year, we should be able to provide feedback, uh, about the feedback from the EMA.
What are next year?
Thank you so much for your for, you're welcome. Thank you.
Okay, thank you shimit. Uh, the next question will come from Tom Bishop.
Tom.
You're connected. I think you just need to unmute.
Um,
Tom's, looks like having some issues. So I will go to the next.
Person is Jesse Sala.
Um,
And he is from Spirit of the Coast Analytics.
Christopher Missling: There's a clear acknowledgment that oral therapies would, quote, "facilitate things," quote, for many countries and be much more accessible for the respective healthcare systems, potentially requiring less extensive monitoring and complex administration compared to injectable monoclonal antibodies. This modality difference is seen as a key factor in potential broader market penetration. At the end of July, ANAVEX was honored to be a part of the program at the 2025 Alzheimer's Association International Conference, AAIC, in Toronto. The sharing of knowledge at these central events is important to help advance dementia science to better support the millions of individuals, families, and communities impacted by Alzheimer's disease. At the AAIC 2025 conference, we were pleased to present the latest findings for blarcamesine. The data were presented by Marwan Sabbagh, Professor of Neurology and Chairman of the Advisory Board of ANAVEX.
Um,
I just need you to unmute Jesse.
Hey there. Can you hear me? All right yeah, great.
19.5 months saved by patients and actually, when benchmarked against the kamian, Cassandra the treatment duration of time saved ratio appears really favorable. In fact, at least according to my group's analysis. It appears to be approximately 76% and 58% respectively. I did have a, a few questions, uh, to start. I was, I was wondering, Dr. Misting theoretically could crispr, technology be used to correct Sigmar 1, genotypes. So turning um a mutation Gene back to Wild type. In this case to make blark cozzine and uh 371 more widely efficacious and even potentially increasing, the market size, is that something that could theoretically be done?
Christopher Missling: The data showed that blarcamesine treated patients continue to accrue benefit through up to four years, as measured by the pre-specified clinical endpoints, ADAS-Cog 13 and ADCS-ADL, respectively. Further presentations at the AAIC 2025 conference featured pre-specified precision medicine phase IIB/III, 48-week ANAVEX-2-7380-04, double-blind clinical trial data on blarcamesine, confirming the upstream mechanism of blarcamesine restoring impaired autophagy as an early event preceding amyloid-beta and tau. Now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of ANAVEX, for a financial summary of the recently reported quarter.
Uh, thank you for the question. I think, in theory, it does the good news that, that Chris technology is advancing rapidly and it's very, uh, much utilized in oncology which we also follow very closely. But the good thing is about the black comedian application, is that for the most patients, the vast majority has a very, um, functional and, uh, wild type fully functional Sigma 1 Gene in other genes. So, they really like, uh, the benefit of most patients are, you don't have to apply anything complicated here at to begin with. And let's get that first out there and there's always a ability to further, you know, improve from there for those who have a mutation and a mutation might not be
Be the perfect, uh, response to black car machine, but still better than Placebo. So, we should basically allow this to proceed.
Sandra Boenisch: Thank you so much, Christopher, and good morning to everyone on the call. I am pleased to share with you today our third quarter financial results for our 2025 fiscal year. Our cash position on June 30 was $101.2 million, and we had no debt. During the quarter, we utilized cash and cash equivalents of $12.5 million in operating activities after taking into account changes in non-cash working capital accounts. As of the quarter end, we anticipate at the current adjusted cash utilization rate and range, an approximate runway of more than three years. Our research and development expenses for the quarter were $10 million, as compared to $11.8 million for the comparable quarter of last year. General and administrative expenses were $4.5 million, as compared to $2.8 million for the comparable quarter of last year.
Okay, great. Thank you for answering that.
Um, additionally, can you tell us more about any Alzheimer's, prevention planning, they're kind of appears to be a, um, an emphasis on that with, um, you know, some of the new slides that you put in the, the corporate slide deck, some emerging preclinical work. Um, and the 2, B 3 delayed start analysis, are you actually looking to potentially run a preventative trial or a pro prophylactic trial in the future?
Sandra Boenisch: Compared to the same quarter of fiscal 2024, an increase in non-cash compensation charges was offset by a decrease in overall cash operating expenses due to the completion of a large manufacturing campaign of blarcamesine to support execution and potential commercial readiness as we advance our therapeutic pipeline. Lastly, we reported a net loss of $13.2 million for the quarter, or $0.16 per share. Thank you, and back to you, Christopher.
We actually do, we had, uh, uh, provided an update. Um, recently that there was, uh, the chance of an animals to prevent the onset of the disease of Dementia in a animals when they were pre-treated, with black carbine and those animals who were not pre treated or with placeable, they developed the properties Dementia in a water maze where they got injected with toxic a better fragments and, uh, I would also recommend for you to keep an eye on a lookout, on a publication, which, uh, is peer-reviewed, I will, uh, uh, address that in more specific detail. So, as a consequence of of that, we stated that we would plan such a study. The question is only, when we
Christopher Missling: Thank you, Sandra. In summary, we are focused on continuing to advance our precision medicine compounds. We are excited to be potentially making a difference for individuals suffering from these diseases by presenting a scalable treatment alternative alongside the ease of oral administration. I would now like to turn the call back to Clint for Q&A.
Are you able to execute this? Because it will be, of course, a very long study and that requires more resources. And so, we want to first, do the step by step by bringing the drug first to market for patients.
Clint Tomlinson: Thank you, Christopher. For our first question today, it will be from Soumit Roy from Jones Research.
Okay, that makes sense. And potentially, you would require a partner for that. Potentially, um, and for my final question, um, you know, we've observed from public, lobbying disclosure filings that anavex has retained Forbes Tate partners for government relations and lobbying services.
Soumit Roy: Hi, Kim. Thanks. Hi, Christopher. Quick question on the congressional four-year data. Trying to understand the graph itself, could you help us explain if the delayed start patients, those who are the ones from the placebo arm of the randomized trial, and just the nature of the curve between the ADAS-Cog 13 readout and the ADL? The ADAS-Cog 13 doesn't separate until 96 weeks. That's like two years versus ADL. Is there any specific thing that's going on there?
We also saw a social media post from Congressman Henry quayar back in May acknowledging a meeting with Annex and this seems to Signal a concerted effort to engage with policy makers. Given the critical role of the FDA and other government bodies in the regulatory process for throughout candidates. Could you provide some color on the specific strategic objectives of these engagements? And what are your key policy and Regulatory goals that you believe this partnership will help you achieve specifically, are there any particular policy discussions or regulatory Frameworks? You are tracking closely that could impact your commercialization and reimbursement.
Christopher Missling: So, it's a good question. You're referring to the four-year open-label extension data?
Soumit Roy: Yes.
Christopher Missling: Let me, yeah. So, let me quickly explain again what is done. The patients are randomized at the beginning on the trial to either receiving placebo or active arm. Those patients who then finish the 48 weeks will get blarcamesine, all of them. So, those patients who started blarcamesine, but they were blinded to it, they didn't know, also stay blinded that when they receive blarcamesine, if they were receiving blarcamesine in the previous 48 weeks. And they are called the continued blarcamesine or early start group. Those patients who now, after they had placebo, because they were randomized to placebo in the first 48 weeks, they now receive also blarcamesine. And what we now look at is the trajectory of the two arms, the early start group, which had blarcamesine since day one, and those, what we call late start group, which had blarcamesine after the placebo control part.
We just want to make uh, aware and raise awareness and it's very commonly done by uh many. If not all companies such activities and it's freely raising the awareness, and helping our, you know, just just legislative side to uh emphasize and provide uh funding and attention to patients with this terrible disease.
As you can see that the Ultima conference recently provided many new features of uh several drug updates. And so that is a requirement which we like to participate in in the education of policy makers about uh the need and unmet need of uh patients with dementia and ultimately specifically
Sure, that makes sense. And um, I I assume that that includes the sigma 1 Europe group as well also teaching regulators and uh clinicians in Europe as well about Sigma 1. Um, and I guess to, to close out my, my segment here is, um, along those lines. I I'm assuming that you have heard of, and you may have mentioned actually previously. But I assume that you've
Christopher Missling: And what we find is that those patients who received the drug later, after placebo first, they do not catch up to the benefit of those patients who had blarcamesine from day one in the previous 48 weeks. And that indicates that if you have Alzheimer’s disease, you want to be not getting it too late because you will not get the full benefit of the drug. And the same applies for both cognition, ADAS-Cog 13, and activities of daily living or function, ADCS-ADL. What we noticed was, because of COVID, though, there was not a perfect transition from the end of the trial of 48 weeks into the open-label extension because sites were shut down. And so the patients were just barely able to measure the last measure of 48 weeks, but the open-label was not accessible until, in some cases, a year later.
Heard of the new accelerated, um, voucher at the FDA? Is that something that Anavex is interested in and looking into?
I would say that. Definitely, yes. Uh, I think every company we've had, we have a program which, uh, deserves attention and acceleration, especially if it's an unmet need. It would very well come to such a program. And so do we, uh, so very much, uh, we look forward to the implementation of it.
I'm sorry. Just to to finish is would you say that the chances of you acquiring that voucher is dependent on whether or not you receive a an approval with the EMA? Or do you not really have an opinion on that? I think that's independent of that, I don't think it's as any correlation. Okay? Sounds good. Thank you. Uh, Dr. Misting and thank you Clint. Yep. You're welcome. Thank you for joining, Jesse.
Okay, I'm gonna try Tom Bishop again. Tom, if you could unmute
Okay. Hi. Good morning.
Christopher Missling: But those patients eventually then joined. And what we found was that we could basically separate two groups, those patients which were not impacted by COVID, so to speak, by this shutdown trial sites, and those received the drug right away in the active arm specifically. And those had the best performance among all candidates. And those patients who got the drug after a longer pause, or drug holiday, we call it also, or interruption, they did not benefit as much, even if they had previously the drug in the active arm in the placebo control part. So, the message is here, the takeaway is twofold. First of all, what I already stated, you want to take the drug as soon as possible once you have an indication and diagnosis of Alzheimer’s disease.
Can you hear me? Yeah, you're good as near as I know. Um, the company has only a371 in a clinical trial right now is is that right?
That's correct. Um, we have in compassionate use though we have anx 273 or black cozzine in the ultimate disease. Uh, right now ongoing
So, are all people that were in a prior trial. Um,
allowed to stay on it basically even if it's an Ole officially but like all those
So we have, uh, started the, the trial, uh, in Australia. And those patients were the first 1 to finish the trial, including the opening extension study. And those were the ones who uh, asked for a continuation and that started also with the phase 2, a study Australia. So Australia has right now patients up to 9 years, including the phase 2, a patient population. Some of them continued to take the drug every day since 2014.
Christopher Missling: Once you start taking blarcamesine, you want to continuously take it and not interrupt it for too long because that would also not be a perfect outcome to keep the cognition and function consistently better. To answer your question about this difference between ADAS-Cog 13 and ADL, I think because of these ADAS-Cog 13, it is more sensitive to immediate actions. ADL has a bit of maybe a latency. The ADL seems to be more smooth in their trajectory than the ADAS-Cog 13. The ADAS-Cog 13 is just more sensitive, possibly, to these changes that I just described. The description in the conference, the graph on the slide shows clearly that those patients who were not interrupted or had a short interruption, they, in the ADAS-Cog 13, had a clearly better outcome in the active arm than those who had an interruption, what I just basically said a minute ago.
But but those on the Ole or also still on it. The ones from Australia, correct? Yep. No no. I mean in Australia. Yes.
I mean, the full OLE, not all of them, only those in Australia continued because the other.
Study participants finished after the open label extension.
Um, okay. Um, so
And also R&D spending is still like 10 million. Um, and so, um, I'm wondering what where that's all going. Um, what whether you could run down, what what people are working on, kind of put some meat on that bone, uh, and and sort of go down through the pipeline in that regard. Parkinson's red schizophrenia, fragile X.
That would be very helpful to see what?
Christopher Missling: I trust that helps to explain the difference.
Soumit Roy: No, that was super helpful. Thank you. Were the patients at the beginning of the open-label extension, were they restaged? Were they still mild stage patients, or some of them progressed to moderate?
Right? Part of this is going into the preparation for manufacturing. So we have a larger amount for the manufacturing platform uh for the CMC and the preparation of the trials which we say, uh, we said we would anticipate to start that is a Parkinson disease study. This is our uh, fragile X uh study in another rare disease. All of these are also preparation expenses included in this R&D um uh quarter outcome.
Christopher Missling: Certainly, some have advanced, especially the placebo ones have advanced. We kept all the patients which were voluntarily in the trial, irrespective of how they advanced or if they had advanced to a more severe form of dementia. Both were all allowed to continue, and the majority did.
Soumit Roy: They were not restaged to assess if they are still mild AD or moderate?
Christopher Missling: There was no need to because they were eligible to continue to stay on study drugs, so irrespective of their staging. Does it make sense? It's not.
Soumit Roy: Yeah.
Christopher Missling: It's not taking away the ability to continue to stay on the study drug.
Soumit Roy: No, I was wondering if your drug could even be applicable to the moderate stage patients.
Christopher Missling: We have seen that actually in the phase 2B, phase 2A study, which was published in 2020, that patients with mild to moderate, so more advanced stage, also benefited from blarcamesine. In a way, we have confirmed a broader therapeutic window for not only for early Alzheimer’s disease but also for mild to moderate.
Get eldo pop and change the dose in the middle of the trial. Those patients are not anymore eligible to be included in the analysis. So you lose power and you have to adjust for that. So we have to find a way to avoid that to happen. So we try to find the best way to design the study, so it's becoming increase the chance of success. And that's what is the reason why we are making this uh, thorough and not jumping right into it.
Okay, and red.
Red is uh, we have we have, we really excited about the red program. Um, what we've done so far, I think once we have more um Clarity on the uh submission with Altima, we would look at that again eventually.
Soumit Roy: One last question. Any guidance on the EMA review or commentary back?
Okay. And um, regarding the EMA decision. Will there be an equivalent of uh like a?
FDA advisory committee opinion before that, uh, EMA advisory committee, so to speak.
Christopher Missling: We stated that we would not provide comments until the final feedback or review is completed, and we stick to that. But we are excited about the progress.
I think it works a bit different. The EMA uh, makes a um,
Soumit Roy: Is that a 10-month review? Could you guide us, help us with understanding the timeline? Filed in November last year.
Christopher Missling: It was filed in November last year. It was accepted in December last year. There is a plus-minus time frame, and it depends also a little bit on variables which are sometimes not anticipated. We estimate that Q1 of next year, we should be able to provide feedback about the feedback from the EMA. Q1 of next year.
Decision based on all participating countries in Europe, which are 27. So everybody has a vote and that's how they are making the chmp recommendation and the, um, European Union Parliament. Then, uh, either adopts it or changes The View on that, uh, mostly, they, they adopted. Uh, so that is how the assessment is done in the European and, uh, filing.
Okay, so put it. Putting it another way. It will we get some preliminary?
Information from the EMA.
you know, up or down
Soumit Roy: Thank you so much for your.
Christopher Missling: You're welcome. Thank you.
Before the final EMA decision is rendered, I think the final decision will be rendered only after the CNP provides their recommendation to the EMA. And then the EMA.
Clint Tomlinson: Okay. Thank you, Soumit. The next questions will come from Tom Bishop. Tom, you are connected, I think. You just need to unmute. Tom's end looks like having some issues, so I will go to the next person. It is Jesse Salvera, and he is from Spirit of the Coast Analytics. I just need you to unmute, Jesse.
Or the opinion makes the uh, recommendation or the, the approval. So that is there's no interim or whatever. So there will be as I pointed out before, probably the first quarter of next year a, uh, a result
Okay. Can can you share with us the state of the art of how you will go forward with selling bar kamasin, if it gets approval? Um, so for example, higher sales, force farmer partner or or any interest in somebody acquiring you, you know, marriage proposals
so, all often
Open. Open the
Jesse Salvera: Hey there. Can you hear me all right?
Clint Tomlinson: Yeah, great.
Jesse Salvera: All right. Good morning, Clint, Dr. Missling. This is Jesse Salvera with Spirit of the Coast Analytics. We are an independent biotech intelligence group. I wanted to congratulate the ANAVEX team, actually, with your newly released data from AAIC. We were exceedingly impressed by the 19.5 months saved by patients. Actually, when benchmarked against Leqembi and Kisunla, the treatment duration to time saved ratio appears really favorable. In fact, at least according to my group's analysis, it appears to be approximately 76% and 58%, respectively. I did have a few questions to start. I was wondering, Dr. Missling, theoretically, could CRISPR technology be used to correct sigma-1 genotype, so turning a mutation gene back to wild type, in this case, to make blarcamesine and ANAVEX-3-71 more widely efficacious and even potentially increasing the market size? Is that something that could theoretically be done?
Um, there's definitely an unmet need uh, to treat patients with an oral therapeutic intervention in Europe, uh, that applies also, for the rest of the world. And so, there are several companies which we have started the dialogue with about marketing, uh, the drug in Europe. But also we have a plan and a proposal ready to if we think that the shareholder, um, would be better.
Soft, uh, with uh, marketing, the drug in Europe alone. So, we are also able to do that. Uh, if that turns out to be more favorable for shareholders, or resulting in a higher share of value creation, um, but we have, uh, the options open until we get there.
Okay, and with regards to 9 cash, um, compensation expenses, which you single hours having gone up. And I guess this is a question for Sandra. But is that increase in large part of function of that line item going up? When the stock price goes up? I'm not sure of the formula.
Christopher Missling: Thank you for the question. I think in theory, it does. The good news is that CRISPR technology is advancing rapidly, and it is very much utilized in oncology, which we also follow very closely. The good thing about the blarcamesine application is that the most patients, the vast majority, have a very functional and wild type, fully functional sigma-1 gene and other genes. There is really like the benefit of most patients are you do not have to apply anything complicated here to begin with. Let us get that first out there. There is always an ability to further improve from there for those who have a mutation, and a mutation might not be the perfect response to blarcamesine, but still better than placebo. We should basically allow this to proceed.
Um, if the stock price is higher when they're granted, then it does impact the value of make it um, a higher value. Yes. It's also a function of how long the vesting period is. Um, and if new awards were granted,
Okay, thank you.
Um,
that's it for me.
Thank you, Tom.
I do have a.
Question from Ram from HC Wayne, right? He's having trouble, uh, with the connections. So I'll ask the question for him.
Um Christopher from Ram. Uh what it likely to be the most important countries in Europe from a commercial standpoint for blood cing.
I think we would call out the Big 3, Germany.
France.
Italy and the UK is not European anymore but those are the countries that would think otherwise to be uh focusing on.
Jesse Salvera: Okay. Great. Thank you for answering that. Additionally, can you tell us more about any Alzheimer’s prevention planning? There appears to be an emphasis on that with some of the new slides that you put in the corporate slide deck, some emerging preclinical work, and the 2B3 delayed start analysis. Are you actually looking to potentially run a preventative trial or a prophylactic trial in the future?
Okay. Uh, a second question from him, does the potential Advent of anti omalo antibodies with significantly lower risk of Arya?
Reduce the need for a safe oral option that does not require MRA based monitoring.
I think the, uh,
Christopher Missling: We actually do. We had provided an update recently that there was the chance of, in animals, to prevent the onset of the disease of dementia in animals when they were pretreated with blarcamesine. Those animals who were not pretreated or with placebo, they developed cognitive dementia in a water maze when they got injected with toxic embedded fragments. I would also recommend for you to keep an eye on a lookout on a publication which is peer-reviewed. I will address that in more specific detail. As a consequence of that, we stated that we would plan such a study. The question is only when we are able to execute this because it will be, of course, a very long study, and that requires more resources. We want to first do this step by step by bringing the drug first to market for patients.
Survey, we received just, uh, last month. Two months ago, was that there's really like a propensity for.
uh, the inability to, uh, utilize
Um, injectable drugs for various reasons. It's not in the DNA to speak of the GPS General Practitioners or neurologists in Europe.
To, uh, administer injectable drugs. It is for that reason a very high bar for penetration, and there's an extremely high preference for that reason to offer an all solution like Blackham, which, uh, is, um, expected to have, for that reason, a much more significant penetration.
Okay, great. And then his last question is, uh, can you give any, uh, insight into when additional orphan indications for black cans in? Maybe disclosed?
So we are preparing and planning a study in another rare disease of a designation and we will disclose it once we're getting there. But it's a very exciting indication with high unmet needs. So we're very excited about that.
Jesse Salvera: Okay, that makes sense. And potentially, you would require a partner for that, potentially. For my final question, we've observed from public lobbying disclosure filings that ANAVEX Life Sciences Corp. has retained Forbes State Partners for government relations and lobbying services. We also saw a social media post from Congressman Henry Cuellar back in May acknowledging a meeting with ANAVEX Life Sciences Corp. This seems to signal a concerted effort to engage with policymakers. Given the critical role of the FDA and other government bodies in the regulatory process for drug candidates, could you provide some color on the specific strategic objectives of these engagements? What are your key policy and regulatory goals that you believe this partnership will help you achieve specifically? Are there any particular policy discussions or regulatory frameworks you are tracking closely that could impact your commercialization and reimbursement?
Okay, great. Um, I may have a follow-up question from schumitsch.
Or hi. Um, thank you again for taking the follow-up question. Um, a bit a bit on the commercialization effort. Um, curious, if you can provide us some kind of timeline when you make the decision, whether to go solo or make the partnership because we are probably inside 6 month, period of potential EMA, uh, decision.
Christopher Missling: You just want to make aware and raise awareness. It is very commonly done by many, if not all, companies, such activities. It is really raising the awareness and helping our legislative side to emphasize and provide funding and attention to patients with this terrible disease. We think that it is important to always keep them up to date. They welcome that very much because they received information from these interactions. The area, as you know, is very dynamic, as you can see that the Alzheimer’s Conference recently provided many new features of several drug updates. That is a requirement which we like to participate in, in the education of policymakers about the need and unmet need of patients with dementia and Alzheimer’s disease specifically.
Yeah, so if you look at the historical data of uh, collaborations up front amount and Milestone, there's a, of course, a higher field of value, uh, achieved. If you were able to partner something, once you have already approval or once you are on the market already, that also has been often the case that acquisition or a partnering took place after the company went and marketed itself. So that would be increased the chances of increasing the value for shareholders. And that's what we are after automatically. So I would say that is the best way to answer this question.
Um, the uh have you filed in the UK because that's not under EMA.
Yep, we are in the planning of doing that. So we mentioned that, um, maybe a quarter or so ago, that we are planning to also reach out to other jurisdictions. So this is in the making, okay? And one last one is, um, with the EA.
If you can share with us, was there any back and forth between the EMA and their questions that caused the clock to stop? Uh, after 1:20 days or
160 days, 181 days. And if Chia chmp, uh, is involved already in the, for the order of explanation,
Jesse Salvera: Sure. That makes sense. And I assume that that includes the sigma-1 Europe group as well, so teaching regulators and clinicians in Europe as well about sigma-1. I guess to close out my segment here, along those lines, I am assuming that you have heard of, and you may have mentioned actually previously, but I assume that you have heard of the new accelerated voucher at the FDA. Is that something that ANAVEX Life Sciences Corp. is interested in and looking into?
So, the uh, procedure is very uh standard. There's nothing unusual in the process and we are abiding by it. So everything is proceeding as standard, and in the, in the process.
In the review process.
Okay, thank you so much.
Thank you. All right, thank you. Sh
So that is the last.
Um, hang on 1 second.
Yep. That's that's the last question, Dr. Missing I turn it back over to you.
Christopher Missling: I would say that definitely, yes. I think every company with a program which deserves attention and acceleration, especially if it is an unmet need, would very welcome such a program. So do we. We very much welcome this program, and we look forward to the implementation of it.
Thank you very much in closing. We will continue to focus on execution and potential commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions. I’d like to thank you, and good morning to everybody again.
Jesse Salvera: I'm sorry. Just to finish, would you say that the chances of you acquiring that voucher are dependent on whether or not you receive an approval with the EMA, or do you not really have an opinion on that?
Thank you, ladies and gentlemen, that will conclude today's conference call. Thank you for participating. You may now. Disconnect
Christopher Missling: I think that's independent of that. I don't think it has any correlation.
Jesse Salvera: Okay. Sounds good. Thank you, Dr. Missling, and thank you, Clint.
Clint Tomlinson: You're welcome.
Christopher Missling: Thank you for joining, Jesse.
Clint Tomlinson: Okay. I am going to try Tom Bishop again. Tom, if you could unmute.
Tom Bishop: Okay. Hi. Good morning. Can you hear me?
Clint Tomlinson: Morning. You're good.
Tom Bishop: Hello?
Clint Tomlinson: As near as I know, the company has only ANAVEX-3-71 in a clinical trial right now. Is that right?
Christopher Missling: That's correct. We have in compassionate use, though, we have ANAVEX-2-73 or blarcamesine in Alzheimer's disease right now ongoing.
Tom Bishop: Are all people that were in a prior trial allowed to stay on it, basically, even if it is an open-label extension officially?
Christopher Missling: We have started the trial in Australia, and those patients were the first ones to finish the trial, including the open-label extension study. Those were the ones who asked for a continuation. That started also with the Phase IIA study in Australia. Australia has right now patients up to nine years, including the Phase IIA patient population. Some of them continued to take the drug every day since 2014.
Tom Bishop: But those on the open-label extension are also still on it?
Christopher Missling: The ones from Australia, correct.
Tom Bishop: No, I mean the.
Christopher Missling: In Australia, yes.
Tom Bishop: I mean the full open-label extension.
Christopher Missling: Not all of them. Only those in Australia continued because the other study participants finished after their open-label extension.
Tom Bishop: Okay. I noticed that R&D spending is still like $10 million. I am wondering where that is all going, whether you could run down what people are working on, kind of put some meat on that bone, and go down through the pipeline in that regard: Parkinson's, Rett, schizophrenia, FragileX. That would be very helpful to see what is.
Christopher Missling: Yeah. Part of this.
Tom Bishop: Right.
Christopher Missling: Part of this is going into the preparation for manufacturing. So we have a larger amount for the manufacturing of blarcamesine for the CMC. The preparation of the trials, which we said we would anticipate to start, that is a Parkinson disease study. This is a FragileX study in another rare disease. All of these are also preparation expenses included in this R&D quarter outcome.
Tom Bishop: That has been quite a while since that Parkinson's, the last Parkinson's study ended. I am just wondering what is holding that back or whether you are waiting for EMA results or whatever.
Christopher Missling: No, it is more like the Parkinson area has gone through a very dynamic shift in understanding of the disease. Given our recent precision medicine analysis finding in Alzheimer, we want to really increase the chance of success of this Parkinson's trial as well. One of the things which makes it challenging in Parkinson disease is that L-DOPA is a very good drug, and patients with Parkinson's do get L-DOPA. You have to understand that if you get L-DOPA and change the dose in the middle of the trial, those patients are not anymore eligible to be included in the analysis. You lose power, and you have to adjust for that. We have to find a way to avoid that to happen. We try to find the best way to design the study so it is becoming increased the chance of success.
Christopher Missling: That is the reason why we are making this thorough and not jumping right into it.
Tom Bishop: Okay. And Rett?
Christopher Missling: Rett, we're really excited about the Rett program, what we've done so far. I think once we have more clarity on the submission with Alzheimer, we would look at that again eventually.
Tom Bishop: Okay. Regarding the EMA decision, will there be an equivalent of an FDA advisory committee opinion before that, an EMA advisory committee, so to speak?
Christopher Missling: I think it works a bit different. The EMA makes a decision based on all participating countries in Europe, which are 27. So, everybody has a vote, and that's how they are making the CHMP recommendation. The European Union parliament then either adopts it or changes the view on that. Mostly, they adopt it. That is how the assessment is done in the European filing.
Tom Bishop: Okay. So, putting it another way, will we get some preliminary information from the EMA, you know, up or down, before the final EMA decision is rendered?
Christopher Missling: The final decision will be rendered only after the CHMP provides their recommendation to the EMA. Then the EMA or the European Union makes the recommendation or the approval. There is no interim or whatever. There will be, as I pointed out before, probably Q1 of next year, a result.
Tom Bishop: Okay. Can you share with us the state of the art of how you will go forward with selling blarcamesine if it gets approval?
Christopher Missling: We have.
Tom Bishop: For example, hired Salesforce, a pharma partner, or any interest in somebody acquiring you, marriage proposals.
Christopher Missling: So all options are open. There is definitely an unmet need to treat patients with an oral therapeutic intervention in Europe. That applies also for the rest of the world. There are several companies which we have started the dialogue with about marketing the drug in Europe. We also have a plan and a proposal ready, if we think that the shareholder would be better served with marketing the drug in Europe alone. So we are also able to do that if that turns out to be more favorable for shareholders or resulting in a higher shareholder value creation. We have the options open until we get there.
Tom Bishop: Okay. With regards to non-cash compensation expenses, which you singled out as having gone up, I guess this is a question for Sandra, but is that increase in large part a function of that line item going up when the stock price goes up? I am not sure of the formula.
Speaker 8: If the stock price is higher when they are granted, then it does impact the value and make it a higher value, yes. It is also a function of how long the vaccine period is and if new awards were granted.
Tom Bishop: Okay. Thank you. That's it for me.
Clint Tomlinson: Thank you, Tom. I do have a question from Soumit Roy from Jones Research. He is having trouble with the connections, so I will ask the question for him. Christopher, from Soumit, what are likely to be the most important countries in Europe from a commercial standpoint for blarcamesine?
Christopher Missling: I think I would call out the big three: Germany, France, Italy. The U.K. is not European anymore, but those are the countries that I would think are the largest ones to be focusing on.
Clint Tomlinson: Okay. A second question from him. Does the potential advent of anti-amyloid antibodies with significantly lower risk of RA reduce the need for a safe oral option that does not require MRI-based monitoring?
Christopher Missling: I think the survey we received just last month, two months ago, was that there is really a propensity for the inability to utilize injectable drugs for various reasons. It is not in the DNA, so to speak, of the GPs, general practitioners, or neurologists in Europe to administer injectable drugs. It is, for that reason, a very high bar for penetration. There is an extremely high preference for that reason to offer an oral solution like blarcamesine, which is expected to have, for that reason, a much more significant penetration.
Clint Tomlinson: Okay, great. His last question is, can you give any insight into when additional orphan indications for blarcamesine may be disclosed?
Christopher Missling: We are preparing and planning a study in another rare disease, orphan designation, and we will disclose it once we are getting there. It is a very exciting indication with high unmet needs, so we are very excited about that.
Clint Tomlinson: Okay, great. I may have a follow-up question from Soumit Roy.
Soumit Roy: Hi. Thank you again for taking the follow-up question. A bit on the commercialization effort. Curious if you can provide us some kind of timeline when you make the decision whether to go solo or make the partnership because we are probably inside the six-month period of potential EMA decision.
Christopher Missling: If you look at the historical data of collaborations upfront, amount, and milestone, there is, of course, a higher shareholder value achieved if you were able to partner something once you have already approval or once you are on the market already. That also has been often the case that acquisition or a partnering took place after the company went and marketed itself. That would increase the chances of increasing the value for shareholders. That is what we are after, ultimately. I would say that is the best way to answer this question.
Soumit Roy: Have you filed in the U.K. because that's not under EMA?
Christopher Missling: We are in the planning of doing that. So we mentioned that maybe a quarter or so ago that we are planning to also reach out to other jurisdictions. This is in the making.
Soumit Roy: Okay. And one last one is, with the EMA, if you can share with us, was there any back and forth between the EMA and their questions that caused the clock to stop after 120 days or 160 days, 181 days, and if CHMP is involved already for the oral explanation?
Christopher Missling: The procedure is very standard. There's nothing unusual in the process, and we are abiding by it. Everything is proceeding as standard in the process, in the review process.
Soumit Roy: Okay. Thank you so much.
Christopher Missling: Thank you.
Clint Tomlinson: All right. Thank you, Soumit. That is the last. Hang on one second. Yes, that's the last question, Dr. Missling. I turn it back over to you.
Christopher Missling: Thank you very much. In closing, we like to continue to focus on execution and potential commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions. I'd like to thank you, and good morning to everybody again.
Clint Tomlinson: Thank you, ladies and gentlemen. That will conclude today's conference call. Thank you for participating. You may now disconnect.