Q2 2025 Anavex Life Sciences Corp Earnings Call
<unk> a question and answer session and during the session if you'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 for replay on <unk> website at Www Dot <unk> Dot com.
Speaker Change: With us today is Dr. Christopher Muzzling, President and Chief Executive Officer and.
Saga Burnish: And saga Burnish principal financial officer.
Saga Burnish: 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.
Saga Burnish: We encourage you to review the company's filings with the SEC. This includes without limitation. The Companys forms 10-K, and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward looking statements.
Saga Burnish: These factors may include without limitation risks inherent in the development and commercialization of potential products and.
Saga Burnish: Certainty and the results of clinical trials or regulatory approvals.
Saga Burnish: Need and ability to obtain future capital.
Dr. Misaligned: And maintenance of intellectual property rights and with that I would like to turn the call over to Dr. Misaligned.
Dr. Misaligned: Thank you Glenn and good morning, everyone.
Dr. Misaligned: Thank you for being with US today to review, our most recently reported financial results and to provide our quarterly business update.
Our portfolio of noninvasive targeted upstream position compounds continues to advance.
Dr. Misaligned: With special focus on Alzheimers disease and schizophrenia.
We also continued to receive feedback from neurologists.
Dr. Misaligned: Bearing convenient orally available and clinically meaningful ultimate disease treatment options.
Dr. Misaligned: Which can be assessed without logistical restrictions.
Dr. Misaligned: In April we were pleased to present open label extension data of Black comedy and for ultimate disease at the ADP The 2025 conference.
Dr. Misaligned: The data confirmed continued clinically meaningful benefit for early also many of these patients.
Dr. Misaligned: Once daily oral black Compazine demonstrated over three years of continuous treatment significant I mean duration on clinical decline in.
Dr. Misaligned: Shown continued clinically meaningful benefit for early Alzheimer's disease patients.
Dr. Misaligned: <unk> com has been treated patients continued to accrue benefit.
Dr. Misaligned: Grew up two full years as measured by the clinical endpoints.
Dr. Misaligned: <unk> 13, and Adcs ADL.
Dr. Misaligned: Last month, Marvin said back professor of neurology.
Dr. Misaligned: At Barrow Neurological Institute and Chairman of <unk> Life Sciences Advisory Board, given oral presentation titled a roadblock Compazine northern mechanism for some of the disease.
Takashi restoration through upstream Sigma one activation.
Dr. Misaligned: Clinical efficacy phase to be slashed III trial.
Speaker Change: The ninth International conference on Alzheimer's disease and related disorders in the Middle East.
Speaker Change: The meeting convened a wide range of health care professionals and community advocates from the Middle East and North Africa, USA Europe and other countries with an interest in MEP epic terminology clinical research Medicine basic science and healthcare advocacy.
Speaker Change: Related to Alzheimer's disease and related disorders in the region.
Speaker Change: Specifically with an emphasis on region specific health care delivery.
Speaker Change: With respect to schizophrenia earlier.
Speaker Change: Earlier this month, we announced the successful completion of enrollment in our phase II clinical study of other rigs 371 for the treatment of schizophrenia.
<unk> disorders in the region, specifically with an emphasis on region specific health care delivery.
Speaker Change: The study has enrolled a total of 71 participants with 16 participants and per day and 55 participants in part B.
Yeah.
With respect to schizophrenia.
Earlier this month, we announced the successful completion of enrollment in our phase II clinical study of <unk> 371 for the treatment of schizophrenia.
Speaker Change: But a of the study which investigated multiple ascending doses has been completed with encouraging preliminary safety and electrical and sort of a graph E. E. G. Biomarker results previously reported.
The study has enrolled a total of 71 participants with 16 participants in per day, and 55 participants in part B.
Part B, which includes more participants and with a longer treatment duration will provide more comprehensive clinical and biomarker data.
Today of the study, which investigated multiple ascending doses has been completed with encouraging preliminary safety and electrical and sort of a gruffy EG biomarker results.
Speaker Change: On the efficacy and safety of <unk> 371 in individuals with schizophrenia.
Speaker Change: We expect to report topline data from this study in the second half of this year.
Obviously reported.
B, which includes more participants and with a longer treatment duration will provide more comprehensive clinical and biomarker data on.
Speaker Change: Since our last update we also expanded our synthetic advisory boards in April we announced the appointment of Professor Doctor Audrey Gabel.
On the efficacy and safety of <unk> hundred 71 in individuals with schizophrenia.
Speaker Change: Our specialist specialist of predictive personalized medicine.
We expect to report topline data from this study in the second half of this year.
Speaker Change: In digital health care in ultimate fees and related disorders to the analytics scientific Advisory Board.
Since our last update we also expanded our Cintas crazy bonds in April we announced the appointment of professor Dr. Audrey Gabel, a specialist specialist of predictive personalized medicine.
Speaker Change: Dr. Cabell is a professor of neurology.
Speaker Change: Prologist and Doctor Neurosciences at the memory Resources Research Center. The ran early dementia referral Center, Andrew European Neurodegenerative Excellence Center of multiyear University, France.
And digital health care in ultimate disease and related disorders.
<unk> scientific Advisory Board.
Speaker Change: It doesn't Capella is also research at the multi year Institute of Neurosciences and member of the European Alzheimer disease consortium.
Dr. Cabell is a professor of neurology.
The religious and Doctor Neurosciences at the memory Resources Research Center. The ran early dementia referral Center, Andrew European Neurodegenerative excellent center of multiyear University fronts.
Speaker Change: And now I would like to direct the call to Sandra Burnish principal financial officer of analytics for a financial summary of the recently reported quarter.
It doesn't gabel has also research at the multiyear Institute of Neurosciences and member of the European Alzheimers disease consortium.
Speaker Change: Okay.
Speaker Change: Thank you Christopher and good morning, everyone.
I'm pleased to share with you today, our second quarter financial results for 2025 fiscal year.
And now I would like to direct the call to Sandra Burnish principal financial officer of analytics for a financial summary of the recently reported quarter.
Speaker Change: Our cash position at March 31st with $115 8 million and we had no debt.
Speaker Change: During the quarter, we utilized cash and cash equivalents of $5 9 million and operating activities.
Thank you Christopher and good morning to everyone.
I'm pleased to share with you today, our second quarter financial results for 2025 fiscal year.
Speaker Change: After taking into account changes in noncash working capital accounts.
Speaker Change: As of quarter end, we anticipate at the current cash utilization rate and Rangers a runway on approximately four years.
Our cash position on March 31st was $115 8 million and we had no debt.
During the quarter, we utilized cash and cash equivalents of $5 9 million in operating activities.
Speaker Change: During our most recent quarter general and administrative expenses were $2 6 million as compared to $2 9 million for the comparable quarter of last year.
After taking into account changes in noncash working capital accounts.
As of quarter end, we anticipate at the current cash utilization rate and ranges a runway approximately four years.
Speaker Change: Our research and development expenses for the quarter were $9 9 million as compared to $9 7 million for the comparable quarter of last year.
During our most recent quarter general and administrative expenses were $2 6 million as compared to $2 9 million for the comparable quarter of last year.
Speaker Change: And lastly, we reported a net loss of 11, nine 2 million for the quarter and 13 cents per share.
Speaker Change: Thank you and now I'll turn the call back over to Christopher Thank.
Our research and development expenses for the quarter were $9 9 million as compared to $9 7 million for the comparable quarter of last year.
Christopher Thank: Thank you Sandra in summary, we are focused on continuing to advance our precision medicine compounds with a special focus on Alzheimer's and schizophrenia.
And lastly, we reported a net loss of $11 2 million for the quarter or 13 cents per share.
Christopher Thank: We are excited to be potentially making a difference.
Christopher Thank: Individuals suffering from these diseases by presenting a scalable treatment alternative alongside the ease of oral administration.
Thank you and now I will turn the call back over to Christopher.
Thank you Sandra in summary, we are focused on continuing to advance our precision medicine compounds with a special focus on autonomous and schizophrenia.
Clint: I'd now like to turn the call back to Clint for Q&A.
Speaker Change: Thank you Christopher.
Speaker Change: So we will begin the Q&A session now if you have a question. Please raise your hand, Brian for it in the Q&A box.
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.
Speaker Change: It looks like our first question is coming from sure right.
Speaker Change: Jones research.
I would now like to turn the call back to Colin for Q&A.
Speaker Change: I think you can go ahead instrument.
Thank you Christopher.
Speaker Change: Good morning, everyone and congrats on all the progress.
So we will begin the Q&A session now if you have a question. Please raise your hand or in the Q&A box.
Speaker Change: Quick question on the on the ads Emma front, what can you tell us about the timeline around.
It looks like our first question is coming from sure right.
Speaker Change: When do you expect to hear back from EMA and if he already had some mid cycle review comments received from the European Agency.
Jones research.
I think you can go ahead sumit.
Speaker Change: So we expect thank you for the question. So we expect to have.
Good morning, everyone and congrats on all the progress.
Speaker Change: A question on the on the Alzheimer front, what can you tell us about.
Speaker Change: From what we compare to other regulatory review cycles that it would probably it takes about 12 months.
Speaker Change: The timeline around when you expect to hear back from EMEA and if he already had some mid cycle review comments received from the European Agency.
Speaker Change: So we submitted in November last year and it was accepted the submission in December last year.
Speaker Change: So we expect thank you for the question. So we expect to have from where we are compared to other regulatory review cycles that it would probably it takes about 12 months.
Speaker Change: So it's probably prudent to estimate by the end of this year or early next quarter that we would get a feedback and I.
Speaker Change: I also want to point out that we will not be able to give interim updates.
Speaker Change: So we submitted in November last year and it was accepted.
Speaker Change: But we will report the decision from the EMA a in its final form.
Speaker Change: <unk> submission in December last year.
Speaker Change: So it's probably prudent to estimate by the end of this year or early next quarter that we would get a feedback and I.
Speaker Change: Got it that's.
Speaker Change: That's really helpful. Second one is for.
Speaker Change: For 2025.
Speaker Change: What what do you see as the key inflection points is it.
Speaker Change: I also want to point out that we will not be able to give interim updates.
Speaker Change: Schizophrenia data data that's coming.
Speaker Change: But we will report the decision from the EMA a.
Speaker Change: Coming up in the second half.
Speaker Change: If you can give us a little bit more details on the trial.
Speaker Change: In its final form.
Speaker Change: Got it that's really helpful. Second one is.
Speaker Change: Patient characteristics and what what would be the bar to beat in these patients.
Speaker Change: For 2025.
Speaker Change: So thank you for the question I think the phase II study in schizophrenia is the first efficacy study of 371. So its a safety study preliminarily and we also are focused in the study on the biomarker effect. So we would be very pleased to.
Speaker Change: What what do you see as the key inflection points is it.
Speaker Change: Schizophrenia data data that's coming.
Speaker Change: Coming up in the second half.
Speaker Change: If you can give us a little bit more details on the trial the.
Speaker Change: Patient characteristics and what what would be the barcode.
Speaker Change: In these patients.
Speaker Change: So thank you for the question I think the phase II study in schizophrenia is the first efficacy study of 371.
C a biomarker.
Speaker Change: The effect of the drug in these patients which are very hard to treat patients and there's a lot of unmet need out there still today.
Speaker Change: So its a safety study preliminarily and we also are focused in the study on the biomarker effect. So we would be very pleased to see a biomarker effect of the drug in these patients which are very hard to treat patients.
Speaker Change: Especially with the negative symptoms so that will be the focus on the trial for the time being we also included some clinical measures, but the focus is really on the safety for the longer duration as well as a biomarker effect of the drug in the brain of patients.
Speaker Change: And there's a lot of unmet need out there still today.
Speaker Change: Especially with the negative symptoms.
Speaker Change: <unk> my using EG, ERP, which has been validated as a potential biomarker for schizophrenia in these patients.
Speaker Change: So that will be the focus on the trials for the time being we also included some clinical measures, but the focus is really on the safety for the longer duration as well as a biomarker effect of the drug.
Speaker Change: Yes.
Speaker Change: Okay. Thank you so much again for taking the questions.
Speaker Change: Thank you.
Speaker Change: In the brain of patients by using EG, ERP, which has been validated as a potential biomarker for schizophrenia in these patients.
Speaker Change: Thank you Sumit.
Speaker Change: It looks like our next call comes from Tom Bishop from D. A research.
Speaker Change: Yeah.
Speaker Change: Tom I think you are active now, but you just need a mute.
Speaker Change: Okay. Thank you so much again for taking the questions. Thank.
Speaker Change: Thank you.
Speaker Change: Alright can you hear me now yeah, that's perfect. Thank you.
Sumit: Thank you Sumit.
Speaker Change: It looks like our next call comes from Tom Bishop from D. A research.
Speaker Change: Alright.
Speaker Change: Sticking with the Schizo Rainier trial.
Sumit: Okay.
Speaker Change: Tom I think you are active now, but you just need on mute.
Speaker Change: You mentioned the longer duration, but I didn't quite understand what that meant.
Speaker Change: So the schizophrenia trial is separate in two parts part a was a short period of single ascending doses.
Speaker Change: Alright can you hear me now yeah, that's perfect. Thank you.
Speaker Change: Alright.
Speaker Change: Sticking with the schizo for near trial.
Speaker Change: And but these are longer duration of 28 days. So it's almost a month and that's what I was referring to that the part B, which includes 55 patients.
Speaker Change: You mentioned the longer duration, but I didn't quite understand what that meant.
Speaker Change: So the schizophrenia trial is separate in two parts part a was a.
Speaker Change: Randomized to placebo or active arm, one to one will give us a.
Speaker Change: Short period of single ascending doses.
Speaker Change: Probably more.
Speaker Change: And part B is a longer duration of 28 days. So it's almost a month and that what I was referring to that.
Speaker Change: Solid picture of the drug effect in this patient.
Speaker Change: Well I kind of meant how many weeks or months.
Speaker Change: Part B, which includes 55 patients are randomized to placebo or active arm one to one will give us a.
Speaker Change: It's four weeks 28 days.
Speaker Change: Okay.
Speaker Change: Okay and can you go into a little more detail about what the company is doing well three possible launch.
Speaker Change: Probably more.
Speaker Change: Solid picture off the drug effect in this patient.
Speaker Change: Of.
Speaker Change: For a conversation.
Speaker Change: In Europe.
Speaker Change: Well I kind of meant how many weeks or months.
Speaker Change: Right. So we have initiated since JP Morgan multiple discussions with potential partners.
Speaker Change: It's four weeks 28 days.
Speaker Change: Okay.
Speaker Change: Okay and can you go into a little more detail about what the company is doing three possible launch.
In discussing if so the drug.
He's available to patients in Europe to move forward quickly with the.
Speaker Change: Of.
Speaker Change: We're accomplishing.
Speaker Change: In Europe.
Speaker Change: With the distribution with the access give providing ethic access to the drug in Europe. We also have discussions with zeros, who also provide us as an alternative confidence in the ability to have.
Speaker Change: Right. So we have initiated since JP Morgan multiple discussions with potential partners.
Speaker Change: In discussing if so the drug is.
Speaker Change: Is available to patients in Europe to move forward quickly with the.
Speaker Change: <unk> sales force set up to move forward also in our independent way if this would be.
Speaker Change: With the distribution with the Axa give providing ethic access to the drug in Europe. We also have discussions with zeros, who also provide us as an alternative confidence in the ability to have.
Speaker Change: More advisable from a value creation point of view, so we'd like to maximize shareholder value and the decision is never a maximize elder value will be decision not to progress, but we are on these fronts.
Speaker Change: <unk> sales force set up to move forward also in our independent way if this would be.
Speaker Change: Active on being ready and so we need to be ready.
Speaker Change: More advisable from a value creation point of view, so we'd like to maximize shareholder value and the decision is whoever it maximizes elder value will be decision ultra progress, but we are on these fronts.
Speaker Change: Okay. That's that's helpful. So basically the choices to partner with.
Speaker Change: A major or somebody active in Europe or to go with a.
Speaker Change: European base.
Speaker Change: Political.
Speaker Change: Sales team.
That these are the options that correct if sold the drug was approved.
Speaker Change: Active on that won't being ready if so we need to be ready.
Speaker Change: Okay now what's being used in the schizophrenia trial. That's a 371 so is that a.
Speaker Change: Okay. That's that's helpful. So basically the choices to partner with.
Speaker Change: A major or somebody active in Europe or to go with a European.
Speaker Change: And that's different from what.
Speaker Change: European base clinical.
Speaker Change: Or conversation right.
Speaker Change: That's correct.
Speaker Change: Sales team.
Speaker Change: So <unk> 371 is a completely different molecule it comes from a different approach and.
That these are the options that correct. If so the drug was approved.
Speaker Change: Okay now what's being used in the schizophrenia trial.
Speaker Change: As different affinity to Sigma one.
Speaker Change: 871, so is that a way that's different from what.
Speaker Change: A receptor so that is completely independent on AV block Compazine, which is called <unk> 273, and it's the product which is called black promising so they're two different drugs okay.
Operator: that are in a listen-only mode.
Operator: Later, we will conduct a question-and-answer session, and during the session, if you'd like to ask a question, please use the Q&A box or raise your hand.
Speaker Change: Or kind of the sea right.
Speaker Change: That's correct.
Speaker Change: So <unk> 371 is a completely different molecule it comes from a different approach and.
Operator: Please note this conference is being recorded and the call will be available for replay on Anavex's website at www.anavex.com.
Speaker Change: That's right.
Speaker Change: What are the other countries that might piggyback on a European approval and then secondly, how are you doing with.
Speaker Change: As different affinity to Sigma one.
Operator: With us today is Dr. Christopher Missling, President and Chief Executive Officer. and Sandra Boenisch, Principal Financial Officer.
Speaker Change: A receptor so that is completely independent on Av block cognizant.
Speaker Change: The F D a Canada, Australia could you cover that.
Speaker Change: Okay.
Operator: 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 the current information and expectations and involve a number of risks and uncertainties. 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 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.
Speaker Change: And if the drug which is called black Amazon So they're two different drugs.
Speaker Change: Yeah very good question.
Speaker Change: So the other countries, who are piggybacking on approvals in regions like Europe EMEA would be.
Speaker Change: That's right.
Speaker Change: And what are the other countries that might piggyback on a European approval and then secondly, how are you doing with.
Speaker Change: I think the entire rest of the World South America this will be a.
Speaker Change: Okay.
Speaker Change: Africa this would be middle east.
Speaker Change: Yeah, if you've covered that.
Speaker Change: Yeah very good question.
Speaker Change: This would be.
Speaker Change: So the other countries, who are piggybacking on approvals in regions like Europe.
Speaker Change: Some countries I think also in the Asian region. So this would be a large number of population as well regarding U K and Canada. We also are planning to proceed in Australia. We're planning to proceed with.
Speaker Change: Okay.
Speaker Change: It'll be I think.
Speaker Change: Okay.
Speaker Change: America this will be a.
Speaker Change: Africa this would be middle east.
Speaker Change: Starting the dialogue with the respective regulatory bodies in parallel this this year.
Speaker Change: This would be.
Speaker Change: Some countries I think also in the Asian region. So this would be a lot.
Operator: and Maintenance of Intellectual Property Rights.
Operator: And with that, I would like to turn the call over to Dr. Missling.
So but are you waiting for word from your first or because I know that the FDA has been kind of.
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 portfolio of non-invasive targeted upstream precision compounds continues to advance, with special focus on Alzheimer's disease and schizophrenia. We also continue to receive feedback from neurologists. preferring convenient, orally available, and clinically meaningful Alzheimer disease treatment options. which can be assessed without logistical restrictions.
Speaker Change: Population well.
Speaker Change: Regarding U K and Canada. We also are planning to proceed in Australia. We're planning to proceed with.
Speaker Change: A possible.
Speaker Change: To have a discussion with them.
Speaker Change: Starting the dialogue with respective regulatory bodies in parallel this this year.
Speaker Change: So that's also that's also the plan correct. So we are we are planning to discuss with these authorities in parallel.
Speaker Change: So but are you waiting for word from your first or because I know that the FDA has been kind of.
Speaker Change: So this is in parallel I would say is the best way to describe it.
Speaker Change: But we're not waiting for the results for <unk>.
Speaker Change: A possible.
Speaker Change: For your first or are we.
Speaker Change: To have a discussion with them.
Speaker Change: That's also that's also the plan correct. So we are we are planning to discuss with these authorities in parallel.
Speaker Change: We could we could wait but it's probably also possible to work in parallel to prepare the discussions so that does not mean that the submission but to initiate the discussions and to get the feedback on the respective authorities and that's what we did with Europe as well remember we.
Speaker Change: So this is in parallel I would say is the best way to describe it.
Christopher Missling: In April, we were pleased to present open-label extension data of black carnitine for Alzheimer's disease at the ADPD 2025 conference. The data confirmed continued clinically meaningful benefits for early Alzheimer's disease patients. One stale oral black carmesine demonstrated over three years of continuous treatment, significant amelioration on clinical decline. and shown continued clinically meaningful benefit for early Alzheimer's disease patients. Larkamazine-treated patients continue to accrue benefits. grew up to four years, as measured by the clinical endpoints of COG13 and ADCS-ADL.
Speaker Change: But we're not waiting for the results for.
Speaker Change: So Europe first or.
Speaker Change: Sure.
Speaker Change: We could we could wait but it's probably also possible to work in parallel to prepare the discussions so that does not mean that submission, but to initiate the discussions and to get the feedback on the respective authorities and that's what we did with Europe as well remember we.
Speaker Change: Had our first initial discussion with European authorities and led to the feedback to submit and are any of those.
Speaker Change: Are any of those plan, though yes, they're still working on that.
Speaker Change: Me.
Speaker Change: Are any of those.
Speaker Change: Planned yet or no.
Planning to meet with Canada in next month or anything like that.
Speaker Change: Had our first initial discussion with European authorities and led to the feedback to submit and Orange.
Speaker Change: We will update once we are we'd get feedback. It's it's not it's too early to provide details on the timing of those discussions but ones we have.
Speaker Change: Are any of those plan, though they're still working on.
Speaker Change: Pardon me or any of those planned yet or no.
Speaker Change: Relevant out out outcome of this.
Speaker Change: We plan to meet with Canada in next month or anything like that and we will update once we are we get feedback. It's it's not it's too early to provide details on the timing of those discussions but once we have.
Speaker Change: And meaningful outcome, we will update you.
Speaker Change: Okay, and if you gave say an approval in November.
Christopher Missling: Last month, Marwan Sabak, Professor of Neurology at Barrientology Institute and Chairman of Anavex's Life Sciences Advisory Board gave an oral presentation titled Oral Glycermosine, Novel Mechanism for Alzheimer's Disease. Octophagy restoration through upstream SIGMA1 activation. Clinical efficacy phase 2b slash 3 trial.
Speaker Change: A number just how.
Speaker Change: Long would it take for that.
Speaker Change: The company to see.
Speaker Change: Revenue in other words, you know the launch process.
Speaker Change: A relevant out out outcome of this.
Speaker Change: Yeah, So in Europe, it's per the approval as parent.
Speaker Change: And meaningful outcome will update you.
Speaker Change: Okay, and if Europe gave say an approval in November.
Speaker Change: All the entire European Union and the sales.
Speaker Change: You pick a number.
Speaker Change: <unk> done the country certain countries you are allowed to market. The next day and other countries in need to first reach an agreement when to proceed on the timing of the first sale. So at various berries and so some countries you can start right away.
Speaker Change: How long would it take for.
Christopher Missling: at the 9th International Conference on Alzheimer's Disease and Related Disorders in the Middle East. The meeting convened a wide range of healthcare professionals and community advocates from the Middle East and North Africa, USA, Europe, and other countries. with an interest in epidemiology, clinical research, medicine, basic science, and healthcare advocacy. related to Alzheimer's disease and related disorders in the region. specifically with an emphasis on region-specific healthcare delivery.
Speaker Change: The company to see revenue in other words the launch prep.
Speaker Change: Yes.
Speaker Change: Yeah, So in Europe, it's per the approval as parent.
Speaker Change: All the entire European Union and the sales.
Speaker Change: It's done a country certain countries you are allowed to market. The next day and other countries in need to first reach an agreement or when to proceed on the timing of the first sale. So at various various and so some countries you can start right away.
Speaker Change: But you'd be in a position I mean to have revenue in that.
Speaker Change: In the March quarter, or anything or it takes six months to get going there.
Speaker Change: Yep I cannot foresee right now there might be some some some logistical questions, but if we are getting.
Speaker Change: But you'd be in a position I mean to add revenue in that.
Christopher Missling: With respect to schizophrenia, earlier this month we announced the successful completion of enrollment in our Phase II clinical study of Anavex 371 for the treatment of schizophrenia. The study has enrolled a total of 71 participants, with 16 participants in part A and 55 participants in part B. Part A of the study, which investigated multiple ascending doses, has been completed with encouraging preliminary safety and electroencephalography, e.g. biomarker results. Previously reported.
Speaker Change: So this would be very likely prepared.
Speaker Change: That's why our working assumption.
Speaker Change: In the March quarter, or anything or it takes six months to get going.
Speaker Change: And my last question is where is where is the drug that's being manufactured and do you have a launch inventory.
Speaker Change: Yep I cannot foresee right now there might be some some.
Speaker Change: We have a large inventory for a launch that's correct and the drug is manufactured by the largest U S manufacturer.
Speaker Change: Some logistical questions, but if we are getting close to this would be very likely prepared.
Speaker Change: And is there any tariff impact.
Speaker Change: That's why our working assumption.
Speaker Change: It's crazy, but [laughter] right, we don't have any visibility on that right now.
Speaker Change: And my last question is where is whereas the drug being manufactured and do you have a launch inventory.
Speaker Change: Okay, Alright, well, thank you very much.
Speaker Change: We have a large inventory for a launch that's correct and the drug has been affected by the largest U S manufacturer.
Speaker Change: <unk>.
Speaker Change: Thank you Tom.
Christopher Missling: Part B, which includes more participants and with a longer treatment duration, will provide more comprehensive clinical and biomarker data on the efficacy and safety of Anavex 371 in individuals with schizophrenia.
Speaker Change: And is there any tariff impact.
Speaker Change: Hum.
Speaker Change: There's another question here Dr misleading.
Speaker Change: It's crazy, but [laughter] right, we don't have any visibility on that right now.
Speaker Change: What would be.
Speaker Change: The.
Speaker Change: The advantage of oral block thomasine for patients.
Speaker Change: Okay, Alright, well. Thank you very much thank you.
Christopher Missling: We expect to report top-line data from the study in the second half of this year.
Speaker Change: I think the advantage for the patient for Black Compazine would be that they're being helped a timely without delays and constrained by cumbersome or limiting inconvenient complex diagnostic procedures and that would allow for quicker time sensitive axis, which continued pool.
Tom Bishop: Thank you Tom.
Tom Bishop: Hum.
Christopher Missling: Since our last update, we also expanded our scientific advisory board.
Tom Bishop: There's another question here Dr misleading.
Tom Bishop: What would be.
Christopher Missling: In April, we announced the appointment of Professor Dr. Audrey Gabell. specialists, specialists of predictive personalized medicine. and Digital Healthcare in Alzheimer's Disease and Related Disorders. to the Anavex Scientific Advisory Board. Dr. Cabel is a professor of neurology, neurologist, and doctor in neurosciences at the Memory Resources Research Center, the Rare and Early Dementia Reference Center, and the European Neurodegenerative Excellence Center of Montpellier University, France. Dr. Cappell is also a researcher at the Montpellier Institute of Neurosciences and member of the European Alzheimer's Disease Consortium.
Tom Bishop: The.
Tom Bishop: The advantage of oral block thomasine for patients.
Speaker Change: It goes on the individual patient when.
Tom Bishop: I think the advantage for the patient for Black Compazine would be that they are being helped a timely without delays and constrains by cumbersome or limiting inconvenient complex diagnostic procedures and that would allow for quicker time sensitive axis, which continued for.
When we compare this to the antibodies it takes up to sometimes six to nine months.
Speaker Change: Once they have been diagnosed and are being seen by the doctor before they even get to the chance of getting the drug and by then they might move into a different brackett from a pathological severity point of view it might not be even any more eligible to that drug.
Tom Bishop: Because on the individual patient when.
Tom Bishop: When we compare this to the antibodies it takes up to sometimes six to nine months.
Tom Bishop: Once they have been diagnosed and are being seen by the doctor before they even get to the chance of getting the drug and by then they might move into a different brackett from a pathological severity point of view it might not be even any more eligible to that drug.
Speaker Change: In our case, a patient could be visited by a physician.
Speaker Change: And the patients will be identified as alzheimer patients.
Sandra Boenisch: 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 Change: It away and the physician would prescribe in black Amazon potentially and he would leave with that a prescription for three months and been told to come back three months later, so that's the difference possibly.
Tom Bishop: In our case, a patient could be visited by a physician.
Sandra Boenisch: Thank you, Christopher.
Sandra Boenisch: Good morning to everyone. I'm pleased to share with you today our second quarter financial results for our 2025 fiscal year. Our cash position on March 31st was $115.8 million and we had no debt. During the quarter, we utilized cash and cash equivalents of $5.9 million in operating activities after taking into account changes in non-cash working capital accounts. As of quarter end, we anticipate, at the current cash utilization rate and ranges, a runway of approximately four years. During our most recent quarter, general and administrative expenses were $2.6 million as compared to $2.9 million for the comparable quarter of last year.
Tom Bishop: And.
Tom Bishop: The patients will be identified as alzheimer patients.
Speaker Change: And then there was a follow up is there any difference I know you kind of touched on it but the similar advantages to family members or physicians.
Tom Bishop: Right away and the physician would prescribe.
Tom Bishop: Prescribing block Amazon potentially and you would leave with a prescription for three months and been told to come back three months later, so that's the difference possibly.
Speaker Change: Yeah. So the advanced for the family would be Theres less caregiver stress.
Speaker Change: And likely less financial strain.
Speaker Change: There is no need to arrange for constant transportation to a hospital to measure on.
Tom Bishop: And then there was a follow up is there any difference I know you kind of touched on it but.
Speaker Change: MRI or bedroom or a pet scan.
Similar advantages to family members or physicians.
Speaker Change: And also there is no impact because of that on the family members on Brooks' schedule, which is not to be unnecessary made it. Some people cannot just take off work to bring grandmother grandfather to the hospital every three weeks or every two weeks and that's a big problem regarding the physician demand.
Tom Bishop: Yes, so the advanced for the family would be Theres, less caregiver stress and likely less financial strain.
Tom Bishop: There's no need to arrange for constant transportation to a hospital to measure on.
Tom Bishop: And MRI or bedroom or a pet scan and also theres no impact because of that on the family members on book schedule, which is not to be honest domain. It. Some people cannot just take off work to bring grandmother grandfather to the hospital every two weeks or every two weeks and that's a big problem.
Sandra Boenisch: Our research and development expenses for the quarter were $9.9 million, as compared to $9.7 million for the comparable quarter of last year. And lastly, we reported a net loss of $11.2 million for the quarter, or $0.13 per share.
Speaker Change: For the physicians would be that there is no logistical barrier for treat band and no need to arrange for.
Speaker Change: For complex invasive pet scans, a lumbar puncture, which is spinal taps.
Speaker Change: And I'll repeat it mris and so basically everybody has less logistical challenges to overcome and the patient is helped right away and when you remember the outcome of the long term extension study presented 80 P D.
Christopher Missling: And now I will turn the call back over to Thank you, Sandra. In summary, we are focused on continuing to advance our precision medicine compounds with a special focus on Alzheimer's and Schizophrenia. 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.
Tom Bishop: Regarding the physicians <unk>.
Tom Bishop: Vantage for the physicians would be that there is no logistical barrier for treat bend.
Tom Bishop: No need to arrange.
Tom Bishop: For complex invasive pet scans, a lumbar puncture, which is spinal taps.
Tom Bishop: And I'll repeat it mris and so basically everybody has less logistical challenges to overcome and the patient is help right away and when you remember the outcome of the long term extension study presented at AAD PD.
Speaker Change: At the conference we demonstrated that if you delayed the treatment of a common theme you delay also the long term benefit. So you basically prevent the patient to stay on a better.
Clint Tomlinson: I would now like to turn the call back to Clint for Q&A.
Clint Tomlinson: Thank you, Christopher. So we will begin the Q&A session now. If you have a question, please raise your hand or enter it in the Q&A box.
Speaker Change: Quality of life level.
Tom Bishop: At the conference we demonstrated that if you delayed the treatment of a common theme you delay also the long term benefit so you're basically prevent the patient to <unk>.
Speaker Change: Which as implications for benefit for dealing with its own life and family interaction and if you believe this you basically are.
Soumit Roy: It looks like our first question is coming from Soumit Roy from Jones Research. I think you can go ahead Soumit.
Speaker Change: Preventing this to happen so it's important to give the drug to the patients once identified as ultimate patient as soon as possible.
Christopher Missling: Good morning everyone and congrats on all the progress. A quick question on the on the Alzheimer front, what can you tell us about the timeline around when you expect to hear back from EMA and if you already had some mid-cycle review comments received from the European Agency? So we expect, thank you for the question, so we expect to have from what we compare to other regulatory review cycles, that it would probably take about 12 months. So we submitted in November last year, and it was accepted, the submission in December last year. So, it's probably prudent to estimate by the end of this year or early next quarter that we would get a feedback.
Tom Bishop: They are better.
Tom Bishop: Quality of life.
Tom Bishop: As implications for benefit for dealing with its own life and family interaction and if you delay. This you basically are.
Speaker Change: Okay. Thank you very much I think that's the end of the questions here.
Speaker Change: So I'll turn it back over to you to close.
Tom Bishop: Preventing this to happen so it's important to give the drug to the patients once identified as ultimate patient as soon as possible.
Speaker Change: Thank you and in closing.
Speaker Change: We continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patients lives living with these devastating conditions. Thank you very much.
Tom Bishop: Okay. Thank you very much I think that's the end of the questions here.
Speaker Change: I'll turn it back over to you to close.
Speaker Change: Thank you, ladies and gentlemen that will conclude today's conference call. We appreciate your participation and you may now disconnect.
Tom Bishop: Thank you and in closing.
We continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions. Thank you very much.
Christopher Missling: And I also want to point out that we will not be able to give interim updates. but we will report the decision from the EMA in its final form. Got it. That's that's really helpful.
Tom Bishop: Thank you, ladies and gentlemen that will conclude today's conference call. We appreciate your participation and you may now disconnect.
Tom Bishop: Yeah.
Soumit Roy: Second one is for 2025. What what do you see as the key inflection points? Is it schizophrenia data that's coming up in the second half?
Tom Bishop: Okay.
Soumit Roy: If you can give us a little bit more details on the trial, the patient characteristics and what what will be the bar to beat in these patients.
Christopher Missling: So thank you for the question.
Christopher Missling: I think the phase 2 study in schizophrenia is the first efficacy study of 371. So it's a safety study preliminarily. And we also focus in the study on the biomarker effect. So we would be very pleased to see a biomarker effect of the drug in these patients, which are very hard to treat patients. And there's a lot of unmet need out there still today.
Christopher Missling: especially with the negative symptoms. So that will be the focus on the trial for the time being. We also included some clinical measures, but the focus is really on the safety for the longer duration, as well as biomarker effect of the drug in the brain of patients by using EG-ERP, which has been validated as a potential biomarker for schizophrenia in these patients.
Tom Bishop: It looks like our next call comes from Tom Bishop from BI Research. Tom, I think you're active now, but you just need to unmute.
Tom Bishop: All right, can you hear me now? Yep, that's perfect. Thank you. All right.
Tom Bishop: Sticking with the schizophrenia trail.
Christopher Missling: You mentioned a longer duration, but I didn't quite understand what that meant. So the schizophrenia trial is separate in two parts. Part A was a short period of single ascending doses. And Part B is a longer duration of 28 days, so it's almost a month. And that's what I was referring to, that the Part B, which includes 55 patients, randomized to placebo or active arm one-to-one, will give us a probably more solid picture of the drug effect in this patient.
Tom Bishop: Well, I kind of meant how many weeks or months. It's four weeks, twenty-eight days.
Christopher Missling: Okay, and can you go into a little more detail about what the company is doing, you know, pre-possible launch of for our crime scene in Europe. Right. So we have initiated, since JP Morgan, multiple discussions with potential partners in discussing, if so, the drug is available to patients in Europe to move forward quickly with the distribution, with the access, providing access to the drug in Europe.
Christopher Missling: We also have discussions with CROs who also provide us, as an alternative, confidence in the ability to have sales force set up to move forward also in an independent way, if this would be more advisable from a value creation point of view. So we'd like to maximize shareholder value, and the decision is whenever it maximizes shareholder value will be the decision how to progress. But we are on this front, active on being ready, so we need to be ready.
Tom Bishop: Okay, that's helpful.
Christopher Missling: So basically, the choice is to partner with a major or somebody active in Europe or to go with a European-based clinical sales 1 These are the options that are correct, if so, the drug was approved.
Tom Bishop: Okay, now, what's being used in the schizophrenia trial, that's A371, so is that a, I mean, that's different from what... That's correct.
Christopher Missling: So, Anavex 371 is a completely different molecule. It comes from a different approach and has different affinities to Sigma-1 receptor. So, that is completely independent of Blacamazine, which is called Anavex 273, and it's a drug which is called Blacamazine. So, they're two different drugs.
Tom Bishop: And what are the other countries that might piggyback on a European approval? And then secondly, how are you doing with the FDA, Canada, Australia, did you cover that? Yeah, very good question. So the other countries who are piggybacking on approvals in regions like Europe, EMA, would be I think the entire rest of the world, South America, this would be Africa, this would be Middle East, this would be some countries I think also in the Asian region. So this would be a large number of population as well.
Christopher Missling: Regarding UK and Canada, we also are planning to proceed in Australia, we're planning to proceed with starting the dialogue with the respective regulatory bodies in parallel this year. So, but are you waiting for word from Europe first or because I know that the FDA has been kind of possible, you know, to have a discussion with them. That's also the plan, correct. So we are planning to discuss with these authorities in parallel, so this is, in parallel I would say is the best way to describe it. But we're not waiting for the results for... were you first or are we...
Christopher Missling: We could wait, but it's probably also possible to work in parallel to prepare the discussion. So that does not mean it's a submission, but to initiate the discussions and to get the feedback on the respective authorities. And that's what we did with Europe as well. Remember, we had our first initial discussion with European authorities and led to the feedback to submit.
Tom Bishop: Are any of those planned, though? Yes, they're still working.
Tom Bishop: Are any of those planned yet, or are we planning to meet with Canada next month or anything like that?
Christopher Missling: We will update once we get feedback.
Tom Bishop: It's too early to provide details on the timing of those discussions. But once we have a relevant outcome of this, a meaningful outcome, we will update. Okay, and if Europe gave, say, an approval in November, just to pick a number. How long would it take for... company to see revenue. In other words, you know, the launch process. Yeah, so in Europe the approval is per the entire European Union and the sales is done per country. Certain countries you're allowed to market the next day and other countries you need to first reach an agreement when to proceed on the timing of the first sale.
Christopher Missling: So it varies and so some countries you can start right away. But you'd be in a position, I mean, to have revenue in the March quarter, are you saying? Or it takes six months to get going?
Christopher Missling: Yeah, I cannot foresee right now. There might be some logistical questions. But if we are getting close to this, we will be very likely prepared. That's why we're working on something.
Christopher Missling: And my last question is, where is the drug being manufactured and do you have a launch inventory? We have a large inventory for a launch. That's correct. And the drug is manufactured by the largest U.S. manufacturer.
Christopher Missling: And is there any tariff impact? It's crazy, but... Right. We don't have any visibility on that right now.
Tom Bishop: Well, thank you very much.
Operator: Thank you, Tom.
Christopher Missling: There's another question here, Dr. Missling. what would be... the advantage of oral glaucoma scene for patients. I think the advantage for the patient for blockarmazine would be that they're being helped timely without delays and constraints by cumbersome or limiting inconvenient complex diagnostic procedures, and that would allow for quicker time-sensitive access, which continued focus on the individual patient. When we compare this to the antibodies, it takes up to sometimes six to nine months once they have been diagnosed and been seen by the doctor before they even get to the chance of getting the drug, and by then they might move into a different bracket from a pathological severity point of view and might not be even any more eligible to that drug.
Christopher Missling: In our case, a patient could be visited by a physician. and the patient would be identified as Alzheimer's patient right away and the physician would prescribe him glaucamazine, potentially, and he would leave with that prescription for three months and be told to come back three months later.
Christopher Missling: So that's the difference, possibly.
Christopher Missling: And then there was a follow-up, is there any difference, I know you kind of touched on it, but the similar advantages to family members or physicians? Yeah, so the advantage for the family would be there's less caregiver stress and likely less financial strain. There's no need to arrange for constant transportation to a hospital to measure an MRI or measure a PET scan. And also there's no impact because of that on the family members' own work schedule, which is not to be underestimated. Some people cannot just take off work to bring grandmother or grandfather to the hospital every three weeks or every two weeks.
Christopher Missling: And that's a big problem. Regarding the physicians, the advantage for the physicians would be that there's no logistical barrier for treatment and no need to arrange for complex invasive PET scans or lumbar puncture, which is spinal taps and or repeated MRIs. And so basically everybody has less logistical challenges to overcome and the patient is helped right away. And when you remember the outcome of the long-term extension study presented at ADPD at the conference, we demonstrated that if you delay the treatment of vacarmazine, you delay also the long-term benefit. So you basically prevent the patient to stay on a better quality of life level, which has implications for benefit for dealing with his own life and family interaction.
Christopher Missling: And if you delay this, you basically are preventing this to happen. So it's important to give the drug to the patient once identified as an ulcerative colitis patient as soon as possible.
Operator: Okay, thank you very much.
Christopher Missling: I think that's the end of the questions here, so I'll turn it back over to you to close.
Christopher Missling: Thank you. And in closing, we continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions.
Operator: Thank you very much.
Operator: Thank you, ladies and gentlemen.
Operator: That'll conclude today's conference call.
Operator: We appreciate your participation and you may now disconnect.