Anavex Life Sciences Q1 2026 Anavex Life Sciences Corp Earnings Call | AllMind AI Earnings | AllMind AI
Q1 2026 Anavex Life Sciences Corp Earnings Call
Speaker #2: Good morning,
Clint Tomlinson: Good morning, everyone, and welcome to the Anavex Life Sciences Fiscal 2026 First 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 a listen-only mode. Later, we will conduct a question-and-answer session, and during this session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note this conference is being recorded, and the call will be available on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on current information and expectations, and involve a number of risks and uncertainties.
Speaker #2: Everyone, and welcome to the Anavex Life Sciences Fiscal 2026 First Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today's call.
Speaker #2: At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and during this session, if you would like to ask a question, please use the Q&A box or raise your hand.
Speaker #2: Please note, this conference is being recorded, and the call will be available on ANAVEX's website at www.anavex.com. With us today are Dr. Christopher Missling, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer.
Speaker #2: Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on current information and uncertainties.
Speaker #2: We encourage you to review the company's filings with the SEC, and this includes without limitation expectations and involve a number of risks and
Clint Tomlinson: We encourage you to review the company's filings with the SEC, and this includes, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. 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. This conference call discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such products will successfully complete clinical development or gain health authority approval. And with that, I would like to turn the call over to Dr. Missling.
Clint Tomlinson: We encourage you to review the company's filings with the SEC, and this includes, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. 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. This conference call discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such products will successfully complete clinical development or gain health authority approval. And with that, I would like to turn the call over to Dr. Missling.
Speaker #1: Company's Form 10-K and 10-Q, which identify specific factors that actual results or events to from those materially forward-looking described in these statements.
Speaker #1: These include, without limitation, many factors that may cause actual results or events to differ materially from those described in these forward-looking statements.
Speaker #1: These factors may include limitations and risks inherent in the development, potential products, and commercialization. Uncertainty in the results of clinical trials or regulatory approvals.
Speaker #1: Need and ability to obtain capital and maintenance of future intellectual property rights. This call discusses agents in investigational uses, development, and is intended to convey and/or conclusions about efficacy or safety.
Speaker #1: There is no guarantee that any uses of investigational may cause such products will successfully complete clinical development or gain health authority approval. With that, I would like to turn over to Doctor Mitchell.
Christopher Missling: Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our First Quarter Financial Results and Quarterly Business Update. As we enter 2026, we continue to progress our innovative clinical pipeline with particular focus on our lead candidate, oral blarcamesine, in early Alzheimer's disease. Based on our commitment to improving the lives of patients with neurological disorders, we remain excited about the therapeutic potential of oral blarcamesine. We look forward to working with the regulatory agencies in Europe and in the US to advance blarcamesine as a potential new treatment option for patients. We recently announced Anavex participation as a key industry partner in ACCESS-AD, a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer's disease across real-world clinical settings.
Christopher Missling: Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our First Quarter Financial Results and Quarterly Business Update. As we enter 2026, we continue to progress our innovative clinical pipeline with particular focus on our lead candidate, oral blarcamesine, in early Alzheimer's disease. Based on our commitment to improving the lives of patients with neurological disorders, we remain excited about the therapeutic potential of oral blarcamesine. We look forward to working with the regulatory agencies in Europe and in the US to advance blarcamesine as a potential new treatment option for patients. We recently announced Anavex participation as a key industry partner in ACCESS-AD, a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer's disease across real-world clinical settings.
Speaker #2: Thank you , Clint , and good morning , everyone . Thank you with us for being
Speaker #2: first quarter today review to our as we business
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Speaker #2: Improving the patients' lives with neurological disorders remains our focus. We are excited about the therapeutic potential of oral blarcamesine. We look forward to working with the regulatory agencies in Europe, the US, and advancing blarcamesine as a new potential treatment option for patients.
Speaker #2: We recently announced Anavex
Speaker #2: In partner . access ad participation , a major new European initiative to accelerate the adoption of innovative and with and diagnostic therapeutic approaches for designed Alzheimer's disease across real world clinical settings .
Christopher Missling: The multi-year program is funded by the European Commission's Innovative Health Initiative and unites leading academic centers, technology developers, industry innovators, and patient organizations to strengthen equitable access to timely and effective Alzheimer's disease care. As part of the consortium, blarcamesine will be evaluated in a clinical prediction study. As an update to our regulatory pathway, in January, we announced feedback from an FDA Type C meeting in which the FDA shared their feedback to Anavex development plans. The meeting discussed the potential pathways to support blarcamesine for Alzheimer's disease. In order to move forward, it is expected that existing data from the Phase IIb/III ANAVEX2-73-AD-004 program will be submitted to the FDA. In December, as expected, the CHMP adopted a negative opinion on the marketing authorization application for blarcamesine. Subsequently, on 18 December, Anavex announced it had requested the EMA to re-examine its opinion.
Christopher Missling: The multi-year program is funded by the European Commission's Innovative Health Initiative and unites leading academic centers, technology developers, industry innovators, and patient organizations to strengthen equitable access to timely and effective Alzheimer's disease care. As part of the consortium, blarcamesine will be evaluated in a clinical prediction study. As an update to our regulatory pathway, in January, we announced feedback from an FDA Type C meeting in which the FDA shared their feedback to Anavex development plans. The meeting discussed the potential pathways to support blarcamesine for Alzheimer's disease. In order to move forward, it is expected that existing data from the Phase IIb/III ANAVEX2-73-AD-004 program will be submitted to the FDA. In December, as expected, the CHMP adopted a negative opinion on the marketing authorization application for blarcamesine. Subsequently, on 18 December, Anavex announced it had requested the EMA to re-examine its opinion.
Speaker #2: The multi-year program is the call . effective care Health organizations to equitable Commission's strengthen Initiative , industry leading academic timely and unites , technology developers patient Innovative funded As consortium , Bleomycin will be evaluated in a prediction clinical study .
Speaker #2: As an update to our regulatory pathway. In January, we announced a Type C meeting with the FDA. Anavex shared their feedback, and FDA meeting plans were discussed.
Speaker #2: development The pathways to support Procarbazine disease Alzheimer in order to move forward . It is expected that existing data from the phase two Anavex to , three 7380 zero four program will be submitted to the FDA in December , as expected , the adopted a negative opinion on the marketing Authorization Application for Procarbazine .
Speaker #2: Subsequently, on December 18th, Anavex announced it had requested the EMA to re-examine its opinion. We are working closely with the EMA during this process, which is being led by a different rapporteur and co-rapporteur.
Christopher Missling: We are working closely with the EMA during this process, which is being led by a different Rapporteur and Co-Rapporteur. In November, we announced presentations at the 18th CTAD conference in San Diego. The oral late-breaking communication oral blarcamesine Phase IIb/III trial confirms identified precision medicine patient population, significant broad clinical and quality-of-life improvements for early Alzheimer's disease patients, and two poster presentations featuring blarcamesine. Looking forward, we will provide both regulatory and clinical trial updates on blarcamesine in other indications such as Parkinson's Disease and Fragile X Syndrome. This will include disclosure of planned future clinical trial designs as we continue to advance our therapeutic pipeline. Additionally, new scientific findings will be presented at upcoming conferences or in upcoming publications.
Christopher Missling: We are working closely with the EMA during this process, which is being led by a different Rapporteur and Co-Rapporteur. In November, we announced presentations at the 18th CTAD conference in San Diego. The oral late-breaking communication oral blarcamesine Phase IIb/III trial confirms identified precision medicine patient population, significant broad clinical and quality-of-life improvements for early Alzheimer's disease patients, and two poster presentations featuring blarcamesine. Looking forward, we will provide both regulatory and clinical trial updates on blarcamesine in other indications such as Parkinson's Disease and Fragile X Syndrome. This will include disclosure of planned future clinical trial designs as we continue to advance our therapeutic pipeline. Additionally, new scientific findings will be presented at upcoming conferences or in upcoming publications.
Speaker #2: In November , we announced presentations at the conference in San . The Oral 18 Ctad , late breaking communication all phase two three trial confirms precision identified medicine , patient population by a , significant broad clinical and quality of life for improvements early disease Alzheimer's patients posters presentations featuring and to .
Speaker #2: Looking we forward , will provide regulatory and both trial updates on Plicamycin clinical in other indications , such as Parkinson's disease and fragile X .
Speaker #2: This will include Diego's planned future clinical trial designs. As we continue to advance our therapeutic pipeline, additionally, new scientific findings will be presented at upcoming conferences or in upcoming publications.
Christopher Missling: An oral presentation at the 16th International Conference on Frailty and Sarcopenia Research for Healthy Longevity to be held March 10 to 12 at Johns Hopkins University Bloomberg Center in Washington, D.C. The new findings on a clinical relationship with a biomarker, correlation between clinical endpoints, and reduced brain region atrophy with blarcamesine in early Alzheimer's disease. A publication on Alzheimer's disease regarding precision medicine, ABCLEAR populations of the ANAVEX2-73 AD004 Phase IIb/III trial. Another publication on Alzheimer's disease on the precision medicine gene COL24A1, with an estimated over 70% prevalence in the early Alzheimer's disease population, which has the potential to establish effective treatment of early Alzheimer's disease through effectiveness of autophagy-enhancing blarcamesine. And a publication regarding Fragile X Syndrome: blarcamesine corrects EEG biomarkers of cortical dysfunction in a mouse model of Fragile X Syndrome.
Christopher Missling: An oral presentation at the 16th International Conference on Frailty and Sarcopenia Research for Healthy Longevity to be held March 10 to 12 at Johns Hopkins University Bloomberg Center in Washington, D.C. The new findings on a clinical relationship with a biomarker, correlation between clinical endpoints, and reduced brain region atrophy with blarcamesine in early Alzheimer's disease. A publication on Alzheimer's disease regarding precision medicine, ABCLEAR populations of the ANAVEX2-73 AD004 Phase IIb/III trial. Another publication on Alzheimer's disease on the precision medicine gene COL24A1, with an estimated over 70% prevalence in the early Alzheimer's disease population, which has the potential to establish effective treatment of early Alzheimer's disease through effectiveness of autophagy-enhancing blarcamesine. And a publication regarding Fragile X Syndrome: blarcamesine corrects EEG biomarkers of cortical dysfunction in a mouse model of Fragile X Syndrome.
Speaker #2: An oral presentation at the Capacity, Frailty and Sarcopenia Research Conference for Healthy Longevity to be held March 10 to 12 at Johns Hopkins University.
Speaker #2: Bloomberg in Center Washington , DC . A new findings on a clinical relationship with a biomarker 16 Intrinsic correlation clinical between endpoints reduced and region brain atrophy black limousine with in early Alzheimer's disease .
Speaker #2: A publication on disease regarding precision medicine . A b clear public populations Alzheimer's 73 AD for of phase two . Phase three trial .
Speaker #2: Another publication anavex2 on Alzheimer's disease on the medicine gene collagen 24 . One , which , with an estimated . over 70% prevalence in the Alzheimer's disease population , which has the potential to precision establish early effective the treatment of early Alzheimer's disease effectiveness of autophagy bleomycin , and a publication , enhancing regarding fragile X procarbazine corrects EEG of cortical dysfunction in a mouse model of fragile X syndrome .
Christopher Missling: With regard to ANAVEX3-71, we will be advancing ANAVEX3-71 towards pivotal clinical studies for the treatment of schizophrenia-related disorders. And 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.
Christopher Missling: With regard to ANAVEX3-71, we will be advancing ANAVEX3-71 towards pivotal clinical studies for the treatment of schizophrenia-related disorders. And 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.
Speaker #2: With biomarkers to ANAVEX 3-71, we will be advancing ANAVEX 3-71 towards clinical studies for the pivotal treatment of schizophrenia-related disorders. I will now direct the call to Sandra Boenisch, Principal Financial Officer of ANAVEX, for a summary of the recently reported quarter. I would like to
Sandra Boenisch: Thanks, Christopher. Good morning to everyone. I am pleased to share with you today our First Quarter Financial Results. Our cash position at December 31 was $131.7 million with no debt. During the quarter, we utilized cash and cash equivalents of $7.1 million in operating activities after taking into account changes in non-cash working capital accounts. As of today, we anticipate that at the current cash utilization rate, our cash runway is more than three years. Our research and development expenses for the quarter were $4.7 million as compared to $10.4 million for the comparable quarter of last year. General and administrative expenses were $2.1 million as compared to $3.1 million for the comparable quarter of last year.
Sandra Boenisch: Thanks, Christopher. Good morning to everyone. I am pleased to share with you today our First Quarter Financial Results. Our cash position at December 31 was $131.7 million with no debt. During the quarter, we utilized cash and cash equivalents of $7.1 million in operating activities after taking into account changes in non-cash working capital accounts. As of today, we anticipate that at the current cash utilization rate, our cash runway is more than three years. Our research and development expenses for the quarter were $4.7 million as compared to $10.4 million for the comparable quarter of last year. General and administrative expenses were $2.1 million as compared to $3.1 million for the comparable quarter of last year.
Speaker #3: Thanks, Christopher. Good everyone. I am
Speaker #3: I would like to share with you today our first quarter financial results. Morning to position at through was $131.7 million, with no December 31st debt.
Speaker #3: During the quarter, we utilized cash and cash equivalents of $7.1 million in operating activities. After accounting for changes in non-cash capital, our accounts taking into...
Speaker #3: As of today, we anticipate that, working at the current cash utilization rate, our runway is more than three years. Our research and development expenses for the quarter were $10.4 million for the comparable quarter of the year. General and administrative expenses were $2.1 million.
Sandra Boenisch: Compared to the same quarter of fiscal 2025, we saw a decrease in operating expenses, mostly driven by the completion of a large manufacturing campaign of blarcamesine conducted in fiscal 2025, and a decrease in clinical trial activities as a result of the completion of our ANAVEX3-71 Phase II study in schizophrenia. And lastly, we reported a net loss of $5.7 million for the quarter, or $0.06 per share. Thanks, and I'll turn it back to you, Christopher.
Sandra Boenisch: Compared to the same quarter of fiscal 2025, we saw a decrease in operating expenses, mostly driven by the completion of a large manufacturing campaign of blarcamesine conducted in fiscal 2025, and a decrease in clinical trial activities as a result of the completion of our ANAVEX3-71 Phase II study in schizophrenia. And lastly, we reported a net loss of $5.7 million for the quarter, or $0.06 per share. Thanks, and I'll turn it back to you, Christopher.
Speaker #3: As compared administrative 3.1 million for the quarter of year last , and same quarter of fiscal 2025 . quarter We saw a operating last expenses , mostly comparable by the completion of a large manufacturing campaign of Camazine in compared to the to decrease in clinical fiscal 2025 trial activities as a result of the completion Anavex
Speaker #3: two study in 371 phase schizophrenia of our . And lastly , we a net loss of 5.7 million for the quarter , or .
Speaker #3: Two studies in 371 Phase schizophrenia are ongoing. And lastly, we reported a net loss of $5.7 million for the quarter, or $0.06 per share.
Christopher Missling: Thank you, Sandra. In summary, we have focused on continuing to advance the development of our precision medicine compounds. We are excited to be potentially making a difference to individuals suffering from neurological diseases by presenting scalable treatment options alongside the ease of oral administration. I would now like to turn the call back to Clint for Q&A.
Christopher Missling: Thank you, Sandra. In summary, we have focused on continuing to advance the development of our precision medicine compounds. We are excited to be potentially making a difference to individuals suffering from neurological diseases by presenting scalable treatment options alongside the ease of oral administration. I would now like to turn the call back to Clint for Q&A.
Speaker #3: Thanks. And I'll hand it over to you, Christopher.
Speaker #2: Sandra . In we
Speaker #2: are focused summary , on continuing to development of our turn it back compounds precision . We are medicine excited to be potentially making a difference advance the individuals from suffering to diseases presenting scalable
Speaker #2: Treatment options alongside the ease of decrease in IV administration. Now, I'd like to turn the call back to Clint. Would oral...
Clint Tomlinson: Thank you, Christopher. We will now begin the Q&A session. If you have a question, please raise your hand or enter it in the Q&A box. Our first question will come from Ram Selvaraju from H.C. Wainwright. You should be connected now, Ram, but I see you muted.
Clint Tomlinson: Thank you, Christopher. We will now begin the Q&A session. If you have a question, please raise your hand or enter it in the Q&A box. Our first question will come from Ram Selvaraju from H.C. Wainwright. You should be connected now, Ram, but I see you muted.
Speaker #1: Thank you . for
Speaker #1: . Q&A We will begin the
Speaker #1: now session . your or enter it in the Q&A box And our will first question come If you have a from hand question , Bram Salvador Wainwright from .
Speaker #1: be connected now . . Ram H.C. . I please raise see you muted But .
Ram Selvaraju: Hello. Can you hear me?
Ram Selvaraju: Hello. Can you hear me?
Clint Tomlinson: Yes.
Clint Tomlinson: Yes.
Ram Selvaraju: Thanks so much for taking our questions. Firstly, I was wondering if you could, at this juncture, provide us with some additional information regarding who the rapporteur and co-rapporteur are for the re-examination of the CHMP opinion on blarcamesine.
Ram Selvaraju: Thanks so much for taking our questions. Firstly, I was wondering if you could, at this juncture, provide us with some additional information regarding who the rapporteur and co-rapporteur are for the re-examination of the CHMP opinion on blarcamesine.
Speaker #4: Hello. Can you hear me?
Speaker #4: Hello. Can you hear me?
Speaker #1: .
Speaker #4: much for taking our questions Firstly I was wondering if you could , at this juncture provide
Speaker #4: Some additional information you should know regarding who the rapporteur and co-rapporteur are for the re-examination of the opinion on CHMP, thanks. So, glaucoma...
Christopher Missling: The 27 countries of the EU decide on two rapporteurs. It is one of the two countries of the 27 will be the rapporteurs.
Christopher Missling: The 27 countries of the EU decide on two rapporteurs. It is one of the two countries of the 27 will be the rapporteurs.
Speaker #2: The of 27 countries the
Speaker #2: two rapporteurs . It two countries of the of the rapporteurs and a 27 will be the is one .
Ram Selvaraju: Okay. Can you provide us with additional information regarding the timeline with which the re-examination is likely to occur? My understanding is that, in effect, it starts at 9:00AM, but that this might be as short as six months. Can you confirm that?
Ram Selvaraju: Okay. Can you provide us with additional information regarding the timeline with which the re-examination is likely to occur? My understanding is that, in effect, it starts at 9:00AM, but that this might be as short as six months. Can you confirm that?
Speaker #4: Okay, can you provide us additional information regarding the CAN timeline, with which the re-examination is likely to occur? My understanding is that, in effect, it starts anew with the clock.
Christopher Missling: That is correct. It is a 60+60-day period where we respond to the re-examination request, and then the review by the two rapporteurs will take another 60 days. So that's why we stated that we expect this process to last for the first half of this year.
Christopher Missling: That is correct. It is a 60+60-day period where we respond to the re-examination request, and then the review by the two rapporteurs will take another 60 days. So that's why we stated that we expect this process to last for the first half of this year.
Speaker #4: But that information could be as short as six months. Can you confirm that?
Speaker #2: That is correct ? It is a 60 plus 60 day where we respond to the re-examination request and
Speaker #2: then review by period the two rapporteurs
Ram Selvaraju: Can you provide a timeline regarding when you anticipate potentially filing formal NDA submission with the FDA?
Ram Selvaraju: Can you provide a timeline regarding when you anticipate potentially filing formal NDA submission with the FDA?
Speaker #2: for the first half of this year.
Speaker #4: Can you provide a regarding timeline—anticipate when you...
Christopher Missling: This is a plan we will advance once we are getting closer, but the last meeting was very productive we had with the FDA, and so we continue with this request which we were giving, that we will provide the full data package to the FDA for addressing their review and expecting next steps from there.
Christopher Missling: This is a plan we will advance once we are getting closer, but the last meeting was very productive we had with the FDA, and so we continue with this request which we were giving, that we will provide the full data package to the FDA for addressing their review and expecting next steps from there.
Speaker #4: potentially a filing formal submission with the NDA the FDA ?
Speaker #2: This is a plan we will we advance once we are getting closer . But the last meeting was very productive . had with We the FDA and so we with request , which we were giving , that we will the provide full continue package this to the FDA for addressing their review and expecting next steps from there .
Speaker #2: data . you .
Ram Selvaraju: Can you just remind us what type of meeting this was that you held with the FDA, the most recent one?
Ram Selvaraju: Can you just remind us what type of meeting this was that you held with the FDA, the most recent one?
Christopher Missling: That was a Type C Meeting.
Christopher Missling: That was a Type C Meeting.
Speaker #4: Can you just tell us what type of meeting this was that you held with the FDA? The most recent one.
Ram Selvaraju: Okay. Thank you.
Ram Selvaraju: Okay. Thank you.
Christopher Missling: Thank you.
Christopher Missling: Thank you.
Speaker #2: There was a Type C meeting.
Speaker #4: Okay . Thank you remind
Clint Tomlinson: Thank you, Ram. Next question comes from Tom Bishop of BI Research. Tom, you should be on now.
Clint Tomlinson: Thank you, Ram. Next question comes from Tom Bishop of BI Research. Tom, you should be on now.
Speaker #2: Thank
Speaker #1: Thank you . . Next with question comes from Tom Bishop BI research of . Tom , you should be now . Ring .
Tom Bishop: Morning. Can you hear me?
Tom Bishop: Morning. Can you hear me?
Clint Tomlinson: Yes. Go ahead.
Clint Tomlinson: Yes. Go ahead.
Tom Bishop: Can you go into a little bit more detail about what additional information will be in the resubmission to the EMA in terms of will ABCLEAR data be in there, brain volume data, COL24A1, and OLE? Can you just give us a little bit more meat on the bone?
Tom Bishop: Can you go into a little bit more detail about what additional information will be in the resubmission to the EMA in terms of will ABCLEAR data be in there, brain volume data, COL24A1, and OLE? Can you just give us a little bit more meat on the bone?
Speaker #5: Can you hear me ?
Speaker #1: ahead on . Go
Speaker #5: Can you go into a little bit more detail about what additional
Speaker #5: In the resubmission to the EMA, yes. In terms of, will ABC clear data be in? Brain volume data call 24, A1, and Olly, can you just give us a little bit more information?
Christopher Missling: That's absolutely possible. So for background, in the resubmission, we are able to address and provide feedback on the arguments why this drug should be re-examined for approval for EMA review. And as a reminder that there is a requirement for granting conditional approval for if the disease is serious, if there's a major unmet need, if the data shows clinically meaningful effects, if there's a strong mechanistic rationale, especially linking genetic variants, and is there supporting evidence from translational data available. And the sponsor is then also committing to a study in executing it and confirming the efficacy during the approval during the approved process. And we are including the data of the AD004 study, the open label study, the data on the ABCLEAR study population, as well as the correlation of the efficacy of the clinical efficacy with the brain atrophy reduction.
Christopher Missling: That's absolutely possible. So for background, in the resubmission, we are able to address and provide feedback on the arguments why this drug should be re-examined for approval for EMA review. And as a reminder that there is a requirement for granting conditional approval for if the disease is serious, if there's a major unmet need, if the data shows clinically meaningful effects, if there's a strong mechanistic rationale, especially linking genetic variants, and is there supporting evidence from translational data available. And the sponsor is then also committing to a study in executing it and confirming the efficacy during the approval during the approved process. And we are including the data of the AD004 study, the open label study, the data on the ABCLEAR study population, as well as the correlation of the efficacy of the clinical efficacy with the brain atrophy reduction.
Speaker #5: bone
Speaker #2: that's absolutely
Speaker #2: So for background in the
Speaker #2: So for background in the
Speaker #2: We are able to address and provide that feedback on arguments. This drug should be re-examined for.
Speaker #2: approval for EMA review . And as a their the that reminder there is a requirement granting conditional approval for if the disease is serious for , if major unmet , if the data shows clinically meaningful effect , if there's a strong mechanistic rationale linking , especially variants need and is there's a a supporting evidence from translational data available , and the sponsor is then also committing to a study in executing it and confirming the efficacy during the approval .
Speaker #2: Genetic, during the approved process and including the data of the 84 study, we are the open-label, open-label study. The data are clear on the study population, as well as on the efficacy and the correlation of clinical efficacy with the brain reduction.
Tom Bishop: Now, was none of that actually in those last few that you mentioned in the original submission such that this could potentially be more persuasive as it is for me?
Tom Bishop: Now, was none of that actually in those last few that you mentioned in the original submission such that this could potentially be more persuasive as it is for me?
Speaker #5: That was, was none of actually in the, you know, those last few that mentioned in the, you, original submission, such that this could potentially be more persuasive as it is for me?
Christopher Missling: Yeah. It's really like a process, I would say. We also understand that is something which a counterparty has to digest. Maybe that is the reason also we've seen now in the past several cases where even with drugs which were prior approved already and with very large companies submitting those trial data, they ended up at the same situation where we ended up today as well. But we can, of course, not guarantee the approval in this re-examination procedure. But it seems to be a question how to repackage or re-articulate the strength of the package or of the data.
Christopher Missling: Yeah. It's really like a process, I would say. We also understand that is something which a counterparty has to digest. Maybe that is the reason also we've seen now in the past several cases where even with drugs which were prior approved already and with very large companies submitting those trial data, they ended up at the same situation where we ended up today as well. But we can, of course, not guarantee the approval in this re-examination procedure. But it seems to be a question how to repackage or re-articulate the strength of the package or of the data.
Speaker #2: Yeah , it's
Speaker #2: Like I would say. And understand that this is something that we have a counterparty to, and maybe that is the reason.
Speaker #2: Also , we've seen in the now past several where even with prior approved already with very drugs , which digest companies submitting and those , large know you were , trial data where ended up at same the situation where we ended today as atrophy well .
Speaker #2: Also , we've seen in the now past several where even with prior approved already with very drugs , which digest companies submitting and those , large know you were , trial data where ended up at same the situation where we ended today as atrophy well up But we can , of course guarantee the in re-examination procedure , not approval .
Speaker #2: But also, this, it seems, is how to or rearticulate the strength of, repackage the package or, of the data.
Tom Bishop: Okay. And with the FDA, I know the question was asked, "When might you file this data with the FDA?" I mean, it kind of already exists. So I was just wondering if you can be any more clear about why you can't get that data to the FDA very soon.
Tom Bishop: Okay. And with the FDA, I know the question was asked, "When might you file this data with the FDA?" I mean, it kind of already exists. So I was just wondering if you can be any more clear about why you can't get that data to the FDA very soon.
Speaker #5: Okay . with And the FDA , I know the question was asked when might you file data with the mean , it kind FDA ? exists .
Speaker #5: Okay . with And the FDA , I know the question was asked when might you file data with the mean , it kind FDA ?
Speaker #5: I was just wondering if you can be any more this clear about why we can't . They can't why you can't get that data to the FDA I very soon .
Christopher Missling: It's in process. You have to also understand the FDA has a certain meeting request which requires some time to schedule. This is in the process as well. So that's why it's not like you just ship something over and then you get feedback. You have to make it in consistency with a meeting request. That's what will happen.
Christopher Missling: It's in process. You have to also understand the FDA has a certain meeting request which requires some time to schedule. This is in the process as well. So that's why it's not like you just ship something over and then you get feedback. You have to make it in consistency with a meeting request. That's what will happen.
Speaker #2: It's in process, and you have to also understand the FDA has a certain meeting, which requires some time to schedule. And this is in the well.
Speaker #2: Process, and that's what will happen, okay.
Speaker #2: as So that's why request , which it's not just ship something over and then feedback . So you have to make it in consistency with a meeting request .
Tom Bishop: Okay. Correct me if I'm getting this wrong here, but are there any trials currently in progress?
Tom Bishop: Okay. Correct me if I'm getting this wrong here, but are there any trials currently in progress?
Speaker #2: get
Speaker #5: Are there any . I'm but are there any currently in progress
Speaker #5: Are there any . I'm but are there any currently in progress
Christopher Missling: The only trial we have ongoing is right now the compassionate use program for Rett Syndrome in three countries in three continents: in Canada, in the UK, and in Australia. We have also the compassionate use ongoing for Alzheimer's disease. So we are planning now the studies in Parkinson's Disease, in Fragile X, and another indication which is not disclosed yet. And we also will proceed with the Alzheimer's trial which I mentioned before.
Christopher Missling: The only trial we have ongoing is right now the compassionate use program for Rett Syndrome in three countries in three continents: in Canada, in the UK, and in Australia. We have also the compassionate use ongoing for Alzheimer's disease. So we are planning now the studies in Parkinson's Disease, in Fragile X, and another indication which is not disclosed yet. And we also will proceed with the Alzheimer's trial which I mentioned before.
Speaker #5: ?
Speaker #2: The
Speaker #2: ongoing is right now . The Compassionate like you Use Program Correct me for Rett Syndrome countries in you three continents ,
Speaker #2: Canada, in UK, in
Speaker #2: Australia trials. And we have also the IF compassionate use ongoing for in three Alzheimer disease. So we are planning now the studies in Parkinson's disease in Fragile and another indication which is not disclosed yet.
Tom Bishop: Okay. Well, it's been a little while since the Rett trial was finished. The Parkinson's trial was finished several years now. I'm just wondering if you can give us any near-term timeline for some of these: schizophrenia just wrapped up, the first trial.
Tom Bishop: Okay. Well, it's been a little while since the Rett trial was finished. The Parkinson's trial was finished several years now. I'm just wondering if you can give us any near-term timeline for some of these: schizophrenia just wrapped up, the first trial.
Speaker #2: And we also will proceed with the Alzheimer trial, which I mentioned before.
Speaker #5: Okay. Well, it's been a little while since the trial was finished. The trial was finished years ago now, and I'm just wondering if you can give us some updates for these additional schizophrenia studies.
Speaker #5: wondering
Speaker #5: Any just wrapped up near-term, so when will we get something in this clinic?
Christopher Missling: Yeah. We also.
Christopher Missling: Yeah. We also.
Speaker #5: timeline
Tom Bishop: We'll get something in this clinic.
Tom Bishop: We'll get something in this clinic.
Christopher Missling: Yeah. Yeah. Absolutely good question. We also plan a schizophrenia program to continue, as I mentioned this morning. So we are really going to be very busy with trials. And we are very excited about it. And just to let you know, the Parkinson's disease trial has not been started yet. It was Parkinson's disease dementia. But it's the basis of which we are executing the Parkinson's disease trial.
Christopher Missling: Yeah. Yeah. Absolutely good question. We also plan a schizophrenia program to continue, as I mentioned this morning. So we are really going to be very busy with trials. And we are very excited about it. And just to let you know, the Parkinson's disease trial has not been started yet. It was Parkinson's disease dementia. But it's the basis of which we are executing the Parkinson's disease trial.
Speaker #5: .
Speaker #2: yeah , question . also plan Yeah , a schizophrenia program to continue , as I mentioned , So Yeah . morning . to be very busy with trials
Speaker #2: We are executing. Thank you.
Speaker #2: . And
Speaker #2: very excited We about it . just And let you absolutely . to know , the Good Parkinson's disease
Speaker #2: not since the Parkinson's been started yet . It Parkinson's disease ,
Tom Bishop: Okay. I guess that's it for me for now.
Tom Bishop: Okay. I guess that's it for me for now.
Speaker #2: , but . basis of
Speaker #2: which we we are
Speaker #2: disease trial Several it's the
Christopher Missling: Thank you.
Christopher Missling: Thank you.
Speaker #5: Okay first trial . .
Clint Tomlinson: Thank you, Tom. The next question will come from Jesse Silveira from Spirit of the Coast Analytics. You can go ahead.
Clint Tomlinson: Thank you, Tom. The next question will come from Jesse Silveira from Spirit of the Coast Analytics. You can go ahead.
Speaker #5: I guess that's it for me for Q1.
Speaker #2: Thank .
Speaker #1: Next, the question will be from Tom Silveira from Spirit of the Coast Analytics. Jesse, you can go ahead.
Jesse Silveira: Can you hear me all right?
Jesse Silveira: Can you hear me all right?
Clint Tomlinson: Yes. Thank you.
Clint Tomlinson: Yes. Thank you.
Jesse Silveira: All right. Good morning. This is Jesse Silveira with Spirit of the Coast Analytics. Thank you for taking my questions today. Before we get into some of my, I guess, more elaborate questions, maybe we can start with some quicker pitches. First up, something a lot of people have been kind of scratching their heads on is clarity for CHMP rejection. In particular, we know that blarcamesine works better for patients with SIGMAR1 wild type.
Jesse Silveira: All right. Good morning. This is Jesse Silveira with Spirit of the Coast Analytics. Thank you for taking my questions today. Before we get into some of my, I guess, more elaborate questions, maybe we can start with some quicker pitches. First up, something a lot of people have been kind of scratching their heads on is clarity for CHMP rejection. In particular, we know that blarcamesine works better for patients with SIGMAR1 wild type.
Speaker #6: You hear me? All can, right.
Speaker #1: Yes . Thank
Speaker #6: Good morning . Hi . This is . A spirit of the coast analytics . Thank you for taking my questions today get into guess , more elaborate questions , my , I maybe we some quicker Jesse pitches .
Speaker #6: something a lot of people have been kind of their on is clarity cGMP rejection in . particular , Before we we know can start that Camazine works with better for patients with First up , Sigmar1
Jesse Silveira: As a part of the CHMP rejection, the agency stated, and I quote, "The main study failed to demonstrate effectiveness and safety of blarcamesine ANAVEX in patients with early Alzheimer's disease who do not have a mutation in the Sigma R1 gene." So this statement appears contrary to the facts because the drug is effective for patients who do not have a mutation in the Sigma R1 gene, also known as Sigma R1 wild type. So is it the company's opinion that the CHMP made an error in how they phrased their rejection, or can you clarify the company's understanding of this statement in particular?
Jesse Silveira: As a part of the CHMP rejection, the agency stated, and I quote, "The main study failed to demonstrate effectiveness and safety of blarcamesine ANAVEX in patients with early Alzheimer's disease who do not have a mutation in the Sigma R1 gene." So this statement appears contrary to the facts because the drug is effective for patients who do not have a mutation in the Sigma R1 gene, also known as Sigma R1 wild type. So is it the company's opinion that the CHMP made an error in how they phrased their rejection, or can you clarify the company's understanding of this statement in particular?
Speaker #6: type wild . As a part of the Chmp rejection , the agency stated . And I quote the main study failed to for demonstrate effectiveness and safety of our Anavex Camazine in patients with early Alzheimer's who disease do not have a scratching mutation in the Sigmar1 gene .
Speaker #6: End quote . statement contrary So this to appears facts , because the is effective for patients do who have a the some of also known gene , as Sigmar1 wild drug type , so is it the Sigmar1 company's opinion you .
Speaker #6: CHMP made an error in how they phrased their rejection? Clarify the company's statement in this particular.
Christopher Missling: Yeah. We would not criticize the regulatory bodies, but we would say that in consistency with our interpretation of the trial, we met the other ADAS-Cog13, and there was more significance in the wild-type sigma-1 receptor population as well as in the CDR-SB, which also was superior in the wild-type compared to the ITT population. The ADCS-ADL endpoint was the only one which was not significant, although it was trending positively. And as we and the academic world found out, that this scale is not sensitive enough to pick up the changes of activities of daily living in 48 weeks in an early Alzheimer's disease population. So that is maybe the only difference in interpretation of the trial that that was maybe differently evaluated.
Christopher Missling: Yeah. We would not criticize the regulatory bodies, but we would say that in consistency with our interpretation of the trial, we met the other ADAS-Cog13, and there was more significance in the wild-type sigma-1 receptor population as well as in the CDR-SB, which also was superior in the wild-type compared to the ITT population. The ADCS-ADL endpoint was the only one which was not significant, although it was trending positively. And as we and the academic world found out, that this scale is not sensitive enough to pick up the changes of activities of daily living in 48 weeks in an early Alzheimer's disease population. So that is maybe the only difference in interpretation of the trial that that was maybe differently evaluated.
Speaker #2: We regulatory
Speaker #2: but would the say that not inconsistency with our interpretation of the would the understanding Adas-cog trial 13 and there was more significant in the wild type , as well in the boxes , which rest also was Sigma1 to the we wild in the type compared to as ITT ADL The Adcs-adl criticize was population the only which of the one was significant , although it bodies , not trending .
Speaker #2: We and the academic world found that this scale is sensitive to pick out the changes in activities of daily living over 48 weeks in an early Alzheimer's population.
Speaker #2: we And the was academic world that this scale is sensitive found pick the changes out met activities of 48 weeks daily early living the in a not Alzheimer's up the maybe in So difference in of the trial only that that was maybe differently But evaluated .
Christopher Missling: But now when you go to the ABCLEAR3 population, you will see - and we submitted that for publication, it's already publicly available in a preprint - that the ABCLEAR3 population, which includes SIGMAR1 wild type carriers with the COL24A1 wild type gene, that those patients have significance, reach significance across the board. So for ADAS-Cog13, for ADCS-ADL, and for CDR-SB. And they're not only achieving significance, but they also achieve this with highly clinically meaningful effect sizes, which are sometimes 2 to 3 times larger than what we have seen so far from other compounds in the pipeline or on the market. So that's kind of like why this is intriguing now to also point that out and have that discussion and put that forward.
Christopher Missling: But now when you go to the ABCLEAR3 population, you will see - and we submitted that for publication, it's already publicly available in a preprint - that the ABCLEAR3 population, which includes SIGMAR1 wild type carriers with the COL24A1 wild type gene, that those patients have significance, reach significance across the board. So for ADAS-Cog13, for ADCS-ADL, and for CDR-SB. And they're not only achieving significance, but they also achieve this with highly clinically meaningful effect sizes, which are sometimes 2 to 3 times larger than what we have seen so far from other compounds in the pipeline or on the market. So that's kind of like why this is intriguing now to also point that out and have that discussion and put that forward.
Speaker #2: now when you go to the Abca3 population , you will see and we submitted that for publication . It's already superior publicly available in a preprint that the abca3 population , which includes of Sigma1 wild type carriers with wild type 24 A1 , gene population .
Speaker #2: those patients have collagen reach the across the board . positively So significant for adas-cog significance 13 for adcs-adl for CDR , sum of the and only achieving they're but significance , also achieve this with highly meaningful effect sizes , which are larger sometimes 2 to 3 times than what we have boxes seen clinically they're not far from so other in compounds and pipeline or on the the kind of why this is intriguing .
Jesse Silveira: Okay. Thank you for that. And I'm going to skip around a minute just because you kind of led into it. So you stated in your Borrell Capital interview with Jason a few weeks ago that the re-examination would be under a CMA path and not a full market authorization. And in that interview, you explained that ADCS-ADL, one of your co-primary endpoints, had been invalidated as a reliable measure during your trial analysis phase due to a lack of sensitivity found within the community despite its previous status as the gold standard in Alzheimer's trials. You then went into detail about new statistical methodology that the company was looking to use featuring a higher p-value threshold of 0.0167. And I know that the company has met ADAS-Cog13 and CDR-SB across all genetic cohorts with this p-value or better.
Jesse Silveira: Okay. Thank you for that. And I'm going to skip around a minute just because you kind of led into it. So you stated in your Borrell Capital interview with Jason a few weeks ago that the re-examination would be under a CMA path and not a full market authorization. And in that interview, you explained that ADCS-ADL, one of your co-primary endpoints, had been invalidated as a reliable measure during your trial analysis phase due to a lack of sensitivity found within the community despite its previous status as the gold standard in Alzheimer's trials. You then went into detail about new statistical methodology that the company was looking to use featuring a higher p-value threshold of 0.0167. And I know that the company has met ADAS-Cog13 and CDR-SB across all genetic cohorts with this p-value or better.
Speaker #2: Now, also, out and have that discussion and put it forward.
Speaker #6: Okay . Thank you for that . And I'm
Speaker #6: kind of So that's I'm going to skip around a minute just because you kind of led into
Speaker #6: So it .
Speaker #6: A few weeks ago, Jason, you had a capital interview with the market to point out that this would not be a full authorization market interview, but rather a re-examination. You explained that ADCS-ADL was one of your co-primary CMA endpoints.
Speaker #6: in that measure during trial analysis phase due to a sensitivity found within the community And . status as Despite lack of trials path and .
Speaker #6: went into detail You then about new standard in methodology that the company was use , your featuring a higher p its value threshold statistical of 0.0167 , and I know that the company has met CDR across all
Jesse Silveira: So the question is, does using this new threshold allow the company to circumnavigate the ADCS-ADL myth? And will regulators, in your view, accept the scientific invalidation of ADCS-ADL combined with your new gatekeeping strategy? If you can give any on that.
Jesse Silveira: So the question is, does using this new threshold allow the company to circumnavigate the ADCS-ADL myth? And will regulators, in your view, accept the scientific invalidation of ADCS-ADL combined with your new gatekeeping strategy? If you can give any on that.
Speaker #6: Cohorts with this value—ADAS-Cog—are better. So, the question is, does using this sum allow the company to threshold Alzheimer's like ADCS-ADL? Will regulators, in your view, accept the scientific approach and allow you to circumnavigate ADCS-ADL, combined with your new gatekeeping strategy?
Christopher Missling: Yeah. As I just stated, this is exactly the discussion which is probably ongoing if this ADL is identified clearly as not valid anymore. And if you follow science, you would agree with that because it's an endpoint which has been earmarked as being useful for overt Alzheimer's, for moderate and severe Alzheimer's, but not sensitive enough for the early Alzheimer's population. And that was confirmed, actually, in guidances from the regulatory bodies. So you would assume that that is a fair argument to have. And we stated that argument and make that argument as well.
Christopher Missling: Yeah. As I just stated, this is exactly the discussion which is probably ongoing if this ADL is identified clearly as not valid anymore. And if you follow science, you would agree with that because it's an endpoint which has been earmarked as being useful for overt Alzheimer's, for moderate and severe Alzheimer's, but not sensitive enough for the early Alzheimer's population. And that was confirmed, actually, in guidances from the regulatory bodies. So you would assume that that is a fair argument to have. And we stated that argument and make that argument as well.
Speaker #6: If you miss, and on that view,
Speaker #2: Yeah , as I just this
Speaker #2: the exactly discussion , which is
Speaker #2: probably any ongoing . If 13 and ADL is this identified clearly as not valid
Speaker #2: you science , follow would stated , is , that
Speaker #2: you science , follow would stated , is , that because
Speaker #2: You agree with earmarked as can give useful Alzheimer for moderate and new severe Alzheimer, sensitive not enough for, but the Alzheimer early being population.
Speaker #2: that And a was confirmed for in guidances from anymore the regulatory bodies . you would So assume that that is a fair argument to have .
Jesse Silveira: Okay. Thank you for that. And with that said, you went over the 60+60-day timeline earlier for this reevaluation. We should be, I believe, near 60 days now. Have you already submitted the new strategy and packaged the CHMP? And has a SAG been appointed yet?
Jesse Silveira: Okay. Thank you for that. And with that said, you went over the 60+60-day timeline earlier for this reevaluation. We should be, I believe, near 60 days now. Have you already submitted the new strategy and packaged the CHMP? And has a SAG been appointed yet?
Speaker #2: Stated argument. And make actually that that argument as and.
Speaker #6: Thank you for Okay . that . And over the said , you 60 60 day with that earlier for timeline this be , We should I believe , near 60 days Have you now .
Christopher Missling: We will update everybody once we have the result of this process. We will not comment on the ongoing process. But the SAG will be part of the review process since we requested that. And we will expect this to be given to us, a dialogue involving the SAG, the scientific advisory group from the EMA, from the neurology team.
Christopher Missling: We will update everybody once we have the result of this process. We will not comment on the ongoing process. But the SAG will be part of the review process since we requested that. And we will expect this to be given to us, a dialogue involving the SAG, the scientific advisory group from the EMA, from the neurology team.
Speaker #6: Already submitted the new strategy and the reevaluation. A package to CHMP has been appointed.
Speaker #2: update
Speaker #2: everybody once we result of will this We
Speaker #2: comment on the ongoing the SAG will be part the review
Speaker #2: of . Yes
Speaker #2: and we will expect this to overt be well given to not , but us . A SAG process involving the SAG , the Scientific Advisory
Speaker #2: and we will expect this to overt be well given to not , but us . A SAG process involving the SAG , the Scientific Advisory Group EMA for
Jesse Silveira: Okay. Thank you. And if I have it correct, you have committed to running a confirmatory phase 4 trial if approved for CMA paying patients as a real-world cohort. Is that correct?
Jesse Silveira: Okay. Thank you. And if I have it correct, you have committed to running a confirmatory phase 4 trial if approved for CMA paying patients as a real-world cohort. Is that correct?
Speaker #2: Neurological has Neurology team yet .
Speaker #6: Okay . Thank if I have it correct , you
Speaker #6: have committed to running a confirmatory plus phase four If for CMA , using paying patients as a world , isn't is process . that trial .
Christopher Missling: Sorry. What patients?
Christopher Missling: Sorry. What patients?
Jesse Silveira: Paying patients in the EU. So assuming you are actually approved under CMA, will you be running a phase 4 trial with these patients?
Jesse Silveira: Paying patients in the EU. So assuming you are actually approved under CMA, will you be running a phase 4 trial with these patients?
Speaker #6: correct ?
Speaker #2: Sorry , what patients .
Christopher Missling: We will run.
Christopher Missling: We will run.
Speaker #6: Like paying patients, real in the EU? Assuming so, you are actually an approved cohort under CMA, will you be patients? With these phase four trials, we will.
Jesse Silveira: Or how would that look, I guess?
Jesse Silveira: Or how would that look, I guess?
Christopher Missling: Yeah. We would run a trial as the regulatory body, the CHMP guidelines, provides for that you get approved. And then in parallel, you will run a confirmatory study. Yes.
Christopher Missling: Yeah. We would run a trial as the regulatory body, the CHMP guidelines, provides for that you get approved. And then in parallel, you will run a confirmatory study. Yes.
Speaker #6: How would that guess .
Speaker #2: Yeah ,
Speaker #2: As a trial, as the regulatory body, the guidelines look...
Jesse Silveira: Okay. I think relevant to additional Alzheimer's trials is on 28 January of this year, Alzheimer Europe launched the Prevalence of Dementia in Europe 2025 report, which projected a 64% surge in dementia across Europe by 2050. Based on our research, it appears that Europe is not on course to meet projected health strategies, especially those centered on dementia. It looks like they're kind of, as the EU, moving away from social work and dementia in favor of defense and economy. So in light of these statements, it's our understanding that Anavex is set to participate in ACCESS-AD funded by the European Commission. Can you please give more detail on how blarcamesine, a currently unapproved drug, is to be involved in this program? Is the company running this trial? What are endpoints and objectives of this trial? When will the first patient be dosed?
Jesse Silveira: Okay. I think relevant to additional Alzheimer's trials is on 28 January of this year, Alzheimer Europe launched the Prevalence of Dementia in Europe 2025 report, which projected a 64% surge in dementia across Europe by 2050. Based on our research, it appears that Europe is not on course to meet projected health strategies, especially those centered on dementia. It looks like they're kind of, as the EU, moving away from social work and dementia in favor of defense and economy. So in light of these statements, it's our understanding that Anavex is set to participate in ACCESS-AD funded by the European Commission. Can you please give more detail on how blarcamesine, a currently unapproved drug, is to be involved in this program? Is the company running this trial? What are endpoints and objectives of this trial? When will the first patient be dosed?
Speaker #2: that . You provides get approved and I parallel a confirmatory
Speaker #2: you
Speaker #6: think And I relevant
Speaker #6: additional is .
Speaker #6: Alzheimer's Since we
Speaker #6: 28th January of this year , Okay . Alzheimer Europe launched the prevalence of running a dementia in Europe requested we report ,
Speaker #6: a 64% surge in across would run Europe by 2050 . Based on research ,
Speaker #6: That on Europe, it is not meeting projected health, especially those dementia, which... And it—they're as a kind of EU moving away, dialogue dementia social work, and dementia from defense in economy.
Speaker #6: and these statements , it's our our understanding that
Speaker #6: is set Anavex participate in access ad funded by the European Commission . to Can you please give more from the how currently a drug in this course to running this is the trial ?
Jesse Silveira: Or anything else you'd like to offer?
Jesse Silveira: Or anything else you'd like to offer?
Speaker #6: Like program ? endpoints objectives of and trial ? When will the dosed or first patient be like to you'd offer anything else you .
Christopher Missling: The ACCESS-AD program is really a great opportunity for acknowledging Anavex as a participant and being part of the ecosystem in Europe for Alzheimer's disease, which involves both academic institutions as well as government entities, and advocacy groups within Europe. So we're very pleased and excited about being part of that. A specific carve-out or not carve-out, especially part of this very large grant, if you like, is a dedicated clinical trial of blarcamesine as a placebo-controlled trial to look for data of prediction of the effect of blarcamesine in Alzheimer's patients, in early Alzheimer's patients. And that involves review of biomarkers and novel biomarkers, looking at autophagy signals and also including efficacy. And we're planning to use this trial also for a regulatory-specific goal. So we will make this trial part of our package for confirming the efficacy of blarcamesine in early Alzheimer's disease.
Christopher Missling: The ACCESS-AD program is really a great opportunity for acknowledging Anavex as a participant and being part of the ecosystem in Europe for Alzheimer's disease, which involves both academic institutions as well as government entities, and advocacy groups within Europe. So we're very pleased and excited about being part of that. A specific carve-out or not carve-out, especially part of this very large grant, if you like, is a dedicated clinical trial of blarcamesine as a placebo-controlled trial to look for data of prediction of the effect of blarcamesine in Alzheimer's patients, in early Alzheimer's patients. And that involves review of biomarkers and novel biomarkers, looking at autophagy signals and also including efficacy. And we're planning to use this trial also for a regulatory-specific goal. So we will make this trial part of our package for confirming the efficacy of blarcamesine in early Alzheimer's disease.
Speaker #6: ?
Speaker #2: The , is to be access
Speaker #2: really a great opportunity
Speaker #2: Knowledging company Anavex And a . As participant involved and being part of ecosystem in Europe for Alzheimer disease , the which involves
Speaker #2: academic institutions as government and advocacy groups within well as Europe . looks like So entities we're very pleased and excited that of specific carve out out , especially part of this very large grant , if you like , is a
Speaker #2: Trial clinical of our Carve Karmazin as a controlled trial—look for data of our prediction placebo of the effects of Black patients in patients Alzheimer involves a—
Speaker #2: and novel review of biomarkers
Speaker #2: at autophagy signals and to also including efficacy . And we're this trial biomarkers also camazine a Karmazin in specific goal . will this .
Christopher Missling: So it's a very intriguing project to be part of. And the ACCESS-AD program consists of multiple features. Among them is also a review of a healthy diet. Also, a supplement diet is part of that. And they're all separate. They're not together. And as I just mentioned, one part is explicitly a trial of blarcamesine in a placebo-controlled clinical trial.
Christopher Missling: So it's a very intriguing project to be part of. And the ACCESS-AD program consists of multiple features. Among them is also a review of a healthy diet. Also, a supplement diet is part of that. And they're all separate. They're not together. And as I just mentioned, one part is explicitly a trial of blarcamesine in a placebo-controlled clinical trial.
Speaker #2: our for make Looking confirming the efficacy of regulatory black in early Alzheimer So it's intriguing to use be of . And the axis program So we consists of multiple of among them project to a of
Speaker #2: packaged healthy ad is , healthy What are diet . Also , a supplement diet disease . is part of that a very . And they're all separate .
Speaker #2: They're not together. And they just mentioned one part is a Karmazin trial of black. You know Karmazin. Clinical explicitly controlled trial.
Jesse Silveira: I'm sorry if you mentioned, is this in early Alzheimer's patients, or is there a preventative component to this trial?
Jesse Silveira: I'm sorry if you mentioned, is this in early Alzheimer's patients, or is there a preventative component to this trial?
Speaker #2: .
Speaker #6: I'm sorry if you mentioned is early Alzheimer's this an patients or is this is there like a preventative component to this trial
Christopher Missling: Yeah. So it's a good question. It could end up being a preventative also, but right now, it's consistent with an early Alzheimer's population as a target population.
Christopher Missling: Yeah. So it's a good question. It could end up being a preventative also, but right now, it's consistent with an early Alzheimer's population as a target population.
Speaker #6: ?
Speaker #2: So Yeah . it's a good question . It could end up being a also preventative also . But right consistent features , with a early as a
Jesse Silveira: Okay. And this would be considered AD006 on your pipeline chart. Is that correct?
Jesse Silveira: Okay. And this would be considered AD006 on your pipeline chart. Is that correct?
Christopher Missling: That's correct. Yes. That would be AD006.
Christopher Missling: That's correct. Yes. That would be AD006.
Speaker #2: population . the six .
Speaker #6: Okay .
Speaker #6: Okay . review
Speaker #6: this would be considered a
Speaker #6: this would be considered a
Jesse Silveira: Okay. Great. And I think I'm finishing up here. Is the Atrophy to Clinical Improvement Analysis or paper complete? And maybe if you could give any expectations on when we could get eyes on that.
Jesse Silveira: Okay. Great. And I think I'm finishing up here. Is the Atrophy to Clinical Improvement Analysis or paper complete? And maybe if you could give any expectations on when we could get eyes on that.
Speaker #6: here And I think is the atrophy correct . to improvement chart . analysis or paper complete . correct . And
Christopher Missling: Yeah. So we have submitted now 3 papers, which I mentioned this morning. And the Atrophy paper is still not submitted but will be submitted soon as well.
Christopher Missling: Yeah. So we have submitted now 3 papers, which I mentioned this morning. And the Atrophy paper is still not submitted but will be submitted soon as well.
Speaker #6: Maybe if I give any expectations on when we eyes on that, that would.
Speaker #7: The
Speaker #2: Yeah . have submitted now three papers which
Speaker #2: Mentioned this morning, could get the atrophy paper is, and not—you could submit it, but clinical will be. So, we submitted soon as well.
Jesse Silveira: Okay. Great. And okay. That's pretty much all I have. Kudos on your JPM presentation and the new website format. They look great. And it's striking how little to lose, I think, the CHMP has by granting a CMA, considering the soundly claim safety and efficacy of the drug on cognition, objective brain atrophy markers, and not to mention patient assessed improvements measured by the Quality of Life AD survey. Yeah. So we have no further questions. And thank you again for having us.
Jesse Silveira: Okay. Great. And okay. That's pretty much all I have. Kudos on your JPM presentation and the new website format. They look great. And it's striking how little to lose, I think, the CHMP has by granting a CMA, considering the soundly claim safety and efficacy of the drug on cognition, objective brain atrophy markers, and not to mention patient assessed improvements measured by the Quality of Life AD survey. Yeah. So we have no further questions. And thank you again for having us.
Speaker #6: Great . Okay . And That's pretty much okay . . on your all I have presentation
Speaker #6: website and the new format . great and it's striking to lose . I think the Chmp has by granting a how little still considering JPM They look soundly claimed safety and efficacy of the drug on
Speaker #6: cognition CMA objective brain atrophy markers , and not mention part you know , the improvements the , measured by the quality of life aid survey .
Speaker #6: patient
Christopher Missling: We appreciate that. Thank you.
Christopher Missling: We appreciate that. Thank you.
Operator 1: Thank you, Jesse. Dr. Missling, we have no more questions at this time.
Christopher Missling: Thank you, Jesse. Dr. Missling, we have no more questions at this time.
Speaker #6: So we have no further questions. Thank you for having us.
Speaker #2: We appreciate Thank you .
Christopher Missling: Thank you. So in closing, we continue to focus on execution as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions. We're energized by the possibility of making a meaningful impact for people living with neurological diseases, offering treatment options that are not only scalable but also far easier to administer through an oral route. By lowering barriers to access and simplifying delivery, we hope to bring innovative therapeutics to a broader population and improve quality of life in a tangible way. Thank you.
Christopher Missling: Thank you. So in closing, we continue to focus on execution as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions. We're energized by the possibility of making a meaningful impact for people living with neurological diseases, offering treatment options that are not only scalable but also far easier to administer through an oral route. By lowering barriers to access and simplifying delivery, we hope to bring innovative therapeutics to a broader population and improve quality of life in a tangible way. Thank you.
Speaker #1: Thank you, Jesse. Missing. We have no questions.
Speaker #2: you Thank
Speaker #2: in assessed . So closing
Speaker #2: focus execution as we to advance our
Speaker #2: focus execution as we to advance our therapeutic pipeline to
Speaker #2: patients' lives. Living with these devastating conditions, energized by the
Speaker #2: making a possibility of Doctor
Speaker #2: Impact for people living with neurological diseases, with treatment options that are not only considerably scalable, but also easier to administer through an oral route.
Speaker #2: Route by lowering barriers to access, and so far we
Speaker #2: delivery , hope to we bring innovative therapeutics to a time broader population and quality of life tangible way . Thank we you .
Operator 1: Thank you, ladies and gentlemen, for participating in the call today. We appreciate it. And this will conclude the conference. You may now disconnect.
Clint Tomlinson: Thank you, ladies and gentlemen, for participating in the call today. We appreciate it. And this will conclude the conference. You may now disconnect.
Speaker #1: ladies and gentlemen , for
Speaker #1: participating call today . We appreciate it . And this will conclude the on conference
