NASDAQ:AVXL Anavex Life Sciences Q2 2025 Earnings Report $7.53 -0.10 (-1.31%) Closing price 05/30/2025 04:00 PM EasternExtended Trading$7.44 -0.09 (-1.13%) As of 05/30/2025 07:45 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Anavex Life Sciences EPS ResultsActual EPS-$0.13Consensus EPS -$0.16Beat/MissBeat by +$0.03One Year Ago EPS-$0.13Anavex Life Sciences Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AAnavex Life Sciences Announcement DetailsQuarterQ2 2025Date5/13/2025TimeBefore Market OpensConference Call DateTuesday, May 13, 2025Conference Call Time8:30AM ETUpcoming EarningsAnavex Life Sciences' Q3 2025 earnings is scheduled for Tuesday, August 5, 2025, with a conference call scheduled at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Anavex Life Sciences Q2 2025 Earnings Call TranscriptProvided by QuartrMay 13, 2025 ShareLink copied to clipboard.PresentationSkip to Participants Operator00:00:00For today's call. At this time, all participants are in a listen only mode. Later, will conduct a question and answer session. And during this session, if you would like to ask a question, please use the q and a box or raise your hand. Please note this conference is being recorded, and the call will be available for replay on Anavex's website at www.Anavex.com. Operator00:00:21With us today is doctor Christopher Missling, president and chief executive officer and Sandra Bernisch, 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 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. Operator00:01:00These 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. And with that, I would like to turn the call over to doctor Misling. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:01:19Thank 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 noninvasive 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's disease treatment options, which can be assessed without logistical restrictions. In April, we were pleased to present open label extension data of blacaramazine for Alzheimer's disease at the ADPD twenty twenty five conference. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:02:15The data confirmed continued clinically meaningful benefit for early Alzheimer's disease patients. Once daily oral blacamazine demonstrated over three years of continuous treatment, significant amelioration on clinical decline and shown continued clinically meaningful benefit for early Alzheimer's disease patients. Blacamycin treated patients continue to accrue benefit through up to four years as measured by the clinical endpoints that is COC13 and ADCS ADL. Last month, Marwan Zabak, professor of neurology at Barone Neurological Institute and chairman of ANAVEX's life sciences advisory board, gave an oral presentation titled Oral Novel Mechanism for Alzheimer's Disease, Autophagy Restoration through Upstream sigma-one Activation, Clinical Efficacy Phase IIbthree Trial. At the ninth International Conference on Alzheimer's Disease and Related Disorders in the Middle East. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:03:28The 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 epidemiology, clinical research, medicine, basic science, and health care advocacy related to Alzheimer's disease and related disorders in the region, specifically with an emphasis on region specific health care delivery. With respect to schizophrenia, earlier this month, we announced the successful completion of enrollment in our Phase II clinical study of ANAVEX three seventy one 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 EEG biomarker results previously reported. 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 three seventy one in individuals with schizophrenia. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:04:56We expect to report top line data from the study in the second half of this year. Since our last update, we also expanded our scientific advisory board. In April, we announced the appointment of professor doctor Audrey Gabel, a specialist specialist of predictive personalized medicine and digital health care in Alzheimer's disease and related disorders to the Anavex Scientific Advisory Board. Doctor Gabel is a professor of neurology, neurologist, and doctor in neurosciences at the Memory Resources Research Center, the RAND Early Dementia Reference Center, and the European Neurodegenerative Excellence Center of Montpellier University France. Doctor. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:05:46Capelle is also a researcher at the Montpellier Institute of Neurosciences and member of the European Alzheimer's Disease Consortium. 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. Sandra BoenischPrincipal Financial Officer & Treasurer at Anavex Life Sciences00:06:10Thank you, Christopher. 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 31 was $115,800,000 and we had no debt. During the quarter, we utilized cash and cash equivalents of $5,900,000 in operating activities after taking into account changes in non cash working capital accounts. Sandra BoenischPrincipal Financial Officer & Treasurer at Anavex Life Sciences00:06:40As 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 $2,600,000 as compared to $2,900,000 for the comparable quarter of last year. Our research and development expenses for the quarter were $9,900,000 as compared to $9,700,000 for the comparable quarter of last year. And lastly, we reported a net loss of $11,200,000 for the quarter or $0.13 per share. Thank you. Sandra BoenischPrincipal Financial Officer & Treasurer at Anavex Life Sciences00:07:18And now I will turn the call back over to Christopher. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:07:20Thank 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. I would now like to turn the call back to Clint for Q and A. Operator00:07:51Thank you, Christopher. So we will begin the Q and A session now. If you have a question, please raise your hand or enter it in the Q and A box. It looks like our first question is coming from Srut Roy from Jones Research. I think you can go ahead, Srut. Soumit RoyBiotech Research Analyst at Jones Trading00:08:11Good morning, everyone, and congrats on all the progress. Thank you. Quick question on the, on the Alzheimer's 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? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:08:31So we expect thank you for the question. So we expect to have, from what we, compared to other regulatory review cycles, that it would probably takes about twelve months. So we submitted in November, and it was accepted, the submission in December. 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 also wanna 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. Soumit RoyBiotech Research Analyst at Jones Trading00:09:15Got it. That's that's really helpful. 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? If you can give us a little bit more details on the trial, the patient characteristics, and what what would be the bar to beat in these patients? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:09:40So thank you for the question. I think the phase two study in schizophrenia is the first efficacy study of March. 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. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:10:09And there's a lot of unmet need out there still today, 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 e g ERP, which has been now validated as a potential biomarker for schizophrenia in these patients. Soumit RoyBiotech Research Analyst at Jones Trading00:10:44Thank you so much again for taking the questions. Thank Soumit RoyBiotech Research Analyst at Jones Trading00:10:48you. Operator00:10:53You, Shumit. 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 BishopAnalyst at BI Research00:11:12Alright. Can you hear me now? Operator00:11:14Yep. That's perfect. Thank you. Tom BishopAnalyst at BI Research00:11:16Alright. Sticking with the schizophrenia trial. You mentioned the longer duration, but I didn't quite understand what that meant. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:11:28So 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 twenty eight days. So it's almost a month. And that what I was referring to that the part b, which includes fifty five patients randomized to placebo or active arm one to one, will give us a probably more solid picture of the drug effect in these patients. Tom BishopAnalyst at BI Research00:12:04Well, I kinda meant how many weeks or months? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:12:07It's four weeks, twenty eight days. Tom BishopAnalyst at BI Research00:12:10Oh, okay. Okay. And can you go into a a little more detail about what the company is doing, you know, pre possible launch of, glorcomazine, in Europe. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:12:26Right. So we have, initiated since JPMorgan multiple discussions with potential partners in discussing if so the drug is available to patients in Europe to move forward quickly with the with the distribution with the access give providing asset access to the drug in Europe. We also have discussions with CROs who also provide us as an alternative confidence in the ability to have Salesforce set up to move forward also in a 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 whoever it maximizes shareholder value will be decision how to progress. But we are on these fronts active on being ready if so, we need to be ready. Tom BishopAnalyst at BI Research00:13:29Okay. That's that's helpful. So, basically, the choice is to to partner with a a major or somebody active in Europe or to go with a, European based clinical sales team. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:13:44That these are the options. That's correct. If so, the drug was approved. Tom BishopAnalyst at BI Research00:13:49Okay. Now what's being used in the schizophrenia trial? That's a three seventy one. So is that a I mean, that's different from glaucomasine. Right? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:14:01That's correct. So ANAVEX three seventy one is a completely different molecule. It comes from a different approach and has different affinities to sigma one receptor. So that is completely independent on of blacamazine, which is called Ganovex two seventy three, and it's the drug which is called blacamazine. So they're two different drugs. Tom BishopAnalyst at BI Research00:14:28Okay. That's fine. Then what are the other countries that might piggyback on a European approval? And then secondly, how are you doing with the FDA, Canada, Australia? Could you cover that? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:14:42Yep. 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 in the Asian region. So this would be a a large number of population as well. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:15:15Regarding 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 this year. Tom BishopAnalyst at BI Research00:15:30So but are you waiting for word from Europe First? Or because I know that the FDA has been kinda a possible, you know, to have a discussion with them. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:15:43That's also the that's also the plan. Correct. So we were 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. Tom BishopAnalyst at BI Research00:15:57But but we're not waiting for the results for for Europe First, or or are we? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:16:04We could we could wait, but it's probably also possible to work in parallel to prepare the discussions. 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 BishopAnalyst at BI Research00:16:31And Are any of those are any of those planned, though, yet? They're still working on it. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:16:37Pardon me? Tom BishopAnalyst at BI Research00:16:38Are any of those, yeah, planned yet? Or, you know, we plan to meet with Canada in next month or, you know, anything like that? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:16:46We will update once we are where 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 relevant out out outcome of this and meaningful outcome, we'll update you. Tom BishopAnalyst at BI Research00:17:06Okay. And and if you're gave, say, an approval in November, just to pick a number, how long would it take for the company to see revenue? In other words, you know, the the launch process. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:17:22So in Europe, it's per the approval is per all the entire European Union, and the sales is done per country. Certain countries, you're allowed to market the next day. In other countries, you need to first reach an agreement when to proceed on the timing of the first sale. So it varies. And so some countries, you can start right away. Tom BishopAnalyst at BI Research00:17:53But you'd be in a position, I mean, to have revenue in the in in the March quarter, are you saying? Or it takes six months to get going? Or Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:18:02I I yep. I cannot foresee right now. There might be some some some logistical questions. But if we are getting close to this, we will be very likely prepared. That's our working assumption. Tom BishopAnalyst at BI Research00:18:18And my last question is where is the drug being manufactured? And do you have a launch inventory? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:18:26We have a large inventory for a launch. That's correct. And the drug is manufactured by the largest US manufacturer. Tom BishopAnalyst at BI Research00:18:33And and is there any tariff impact? It's crazy. But Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:18:38Right. We don't have any visibility on that right now. Tom BishopAnalyst at BI Research00:18:45Okay. Alright. Well, thank you very much. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:18:47Thank you. Operator00:18:51K, Don. There's another question here, doctor Missling. What would be the advantage of oral blarcamesine for patients? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:19:11I think the advantage for the patient for blarcamesine 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. In our case, a patient could be visited by a physician and the patient would be identified as Alzheimer patients right away. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:20:11And the physician would prescribe him blacamazine potentially, and he would, leave with that, prescription for three months and be told to come back three months later. So that's the difference possibly. Operator00:20:26And then there was a follow-up. Is there any difference? I know you kinda touched on it, but the similar advantages to family members or physicians? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:20:36Yeah. 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, grandfather to the hospital every three weeks or every two weeks, and that's a big problem. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:21:12Regarding 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 vacamazine, 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. And if you delay this, you basically are preventing this to happen. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:22:24So it's important to give the drug to the patients once identified as Alzheimer patient as soon as possible. Operator00:22:35Okay. Thank you very much. I think that's the end of the questions here. So I'll turn it back over to you to close. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:22:42Thank 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. Operator00:23:01Thank you, ladies and gentlemen. That'll conclude today's conference call. We appreciate your participation, and you may now disconnect.Read moreParticipantsExecutivesChristopher MisslingPresident & Chief Executive OfficerAnalystsSandra BoenischPrincipal Financial Officer & Treasurer at Anavex Life SciencesSoumit RoyBiotech Research Analyst at Jones TradingTom BishopAnalyst at BI ResearchPowered by Key Takeaways Open‐label extension data for once‐daily oral blacaramazine showed over three years of continuous treatment and continued clinically meaningful benefit through four years on key Alzheimer’s endpoints (COG13 and ADCS-ADL). Enrollment is complete in the Phase II trial of ANAVEX 3-71 for schizophrenia (71 participants), with Part B’s 28-day safety and EEG biomarker data expected to drive top-line results in H2 2025. The company ended Q2 with a strong cash position of $115.8 million, no debt, and a burn of $5.9 million for the quarter, providing an estimated four-year runway. Anavex’s blacaramazine EU submission was accepted in December and EMA feedback is expected by year-end or early next quarter, with parallel regulatory discussions planned in the UK, Canada and Australia. Commercial readiness plans include exploring partnerships or building an in-house salesforce in Europe, capitalizing on the oral therapy’s convenience to reduce patient and caregiver logistical barriers. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallAnavex Life Sciences Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipants Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Anavex Life Sciences Earnings HeadlinesNoteworthy Tuesday Option Activity: TOL, AVXL, PIIMay 21, 2025 | nasdaq.comAnavex Life Sciences Corp.'s (NASDAQ:AVXL) largest shareholders are individual investors with 60% ownership, institutions own 37%May 17, 2025 | finance.yahoo.comThe “black glass” breakthrough behind AI’s next leapAI is advancing fast… But there’s one problem almost no one’s talking about. Power.June 1, 2025 | True Market Insiders (Ad)Does Anavex's Alzheimer's Drug Actually Confer Benefit?May 15, 2025 | seekingalpha.comThe Unusual Effects Of Anavex's Blarcamesine On Alzheimer's Disease (Upgrade)May 15, 2025 | seekingalpha.comAnavex Life Sciences Corp. (AVXL) Q2 2025 Earnings Call TranscriptMay 15, 2025 | seekingalpha.comSee More Anavex Life Sciences Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Anavex Life Sciences? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Anavex Life Sciences and other key companies, straight to your email. Email Address About Anavex Life SciencesAnavex Life Sciences (NASDAQ:AVXL), a clinical stage biopharmaceutical company, engages in the development of therapeutics for the treatment of central nervous system diseases. Its lead product candidate is ANAVEX 2-73 for the treatment of Alzheimer's disease and Parkinson's disease, as well as other central nervous system diseases, including rare diseases, such as Rett syndrome, a rare severe neurological monogenic disorder; and infantile spasms, Fragile X syndrome, and Angelman syndrome. The company's drug candidate also comprises ANAVEX 3-71, which is in clinical trial for the treatment of schizophrenia, frontotemporal dementia, and Alzheimer's disease. Its preclinical drug candidates include ANAVEX 1-41 for the treatment of depression, stroke, and neurogenerative disease; ANAVEX 1066 for the potential treatment of neuropathic and visceral pain; and ANAVEX 1037 to treat prostate and pancreatic cancer. The company was incorporated in 2004 and is headquartered in New York, New York.View Anavex Life Sciences ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles e.l.f. 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PresentationSkip to Participants Operator00:00:00For today's call. At this time, all participants are in a listen only mode. Later, will conduct a question and answer session. And during this session, if you would like to ask a question, please use the q and a box or raise your hand. Please note this conference is being recorded, and the call will be available for replay on Anavex's website at www.Anavex.com. Operator00:00:21With us today is doctor Christopher Missling, president and chief executive officer and Sandra Bernisch, 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 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. Operator00:01:00These 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. And with that, I would like to turn the call over to doctor Misling. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:01:19Thank 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 noninvasive 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's disease treatment options, which can be assessed without logistical restrictions. In April, we were pleased to present open label extension data of blacaramazine for Alzheimer's disease at the ADPD twenty twenty five conference. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:02:15The data confirmed continued clinically meaningful benefit for early Alzheimer's disease patients. Once daily oral blacamazine demonstrated over three years of continuous treatment, significant amelioration on clinical decline and shown continued clinically meaningful benefit for early Alzheimer's disease patients. Blacamycin treated patients continue to accrue benefit through up to four years as measured by the clinical endpoints that is COC13 and ADCS ADL. Last month, Marwan Zabak, professor of neurology at Barone Neurological Institute and chairman of ANAVEX's life sciences advisory board, gave an oral presentation titled Oral Novel Mechanism for Alzheimer's Disease, Autophagy Restoration through Upstream sigma-one Activation, Clinical Efficacy Phase IIbthree Trial. At the ninth International Conference on Alzheimer's Disease and Related Disorders in the Middle East. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:03:28The 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 epidemiology, clinical research, medicine, basic science, and health care advocacy related to Alzheimer's disease and related disorders in the region, specifically with an emphasis on region specific health care delivery. With respect to schizophrenia, earlier this month, we announced the successful completion of enrollment in our Phase II clinical study of ANAVEX three seventy one 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 EEG biomarker results previously reported. 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 three seventy one in individuals with schizophrenia. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:04:56We expect to report top line data from the study in the second half of this year. Since our last update, we also expanded our scientific advisory board. In April, we announced the appointment of professor doctor Audrey Gabel, a specialist specialist of predictive personalized medicine and digital health care in Alzheimer's disease and related disorders to the Anavex Scientific Advisory Board. Doctor Gabel is a professor of neurology, neurologist, and doctor in neurosciences at the Memory Resources Research Center, the RAND Early Dementia Reference Center, and the European Neurodegenerative Excellence Center of Montpellier University France. Doctor. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:05:46Capelle is also a researcher at the Montpellier Institute of Neurosciences and member of the European Alzheimer's Disease Consortium. 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. Sandra BoenischPrincipal Financial Officer & Treasurer at Anavex Life Sciences00:06:10Thank you, Christopher. 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 31 was $115,800,000 and we had no debt. During the quarter, we utilized cash and cash equivalents of $5,900,000 in operating activities after taking into account changes in non cash working capital accounts. Sandra BoenischPrincipal Financial Officer & Treasurer at Anavex Life Sciences00:06:40As 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 $2,600,000 as compared to $2,900,000 for the comparable quarter of last year. Our research and development expenses for the quarter were $9,900,000 as compared to $9,700,000 for the comparable quarter of last year. And lastly, we reported a net loss of $11,200,000 for the quarter or $0.13 per share. Thank you. Sandra BoenischPrincipal Financial Officer & Treasurer at Anavex Life Sciences00:07:18And now I will turn the call back over to Christopher. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:07:20Thank 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. I would now like to turn the call back to Clint for Q and A. Operator00:07:51Thank you, Christopher. So we will begin the Q and A session now. If you have a question, please raise your hand or enter it in the Q and A box. It looks like our first question is coming from Srut Roy from Jones Research. I think you can go ahead, Srut. Soumit RoyBiotech Research Analyst at Jones Trading00:08:11Good morning, everyone, and congrats on all the progress. Thank you. Quick question on the, on the Alzheimer's 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? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:08:31So we expect thank you for the question. So we expect to have, from what we, compared to other regulatory review cycles, that it would probably takes about twelve months. So we submitted in November, and it was accepted, the submission in December. 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 also wanna 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. Soumit RoyBiotech Research Analyst at Jones Trading00:09:15Got it. That's that's really helpful. 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? If you can give us a little bit more details on the trial, the patient characteristics, and what what would be the bar to beat in these patients? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:09:40So thank you for the question. I think the phase two study in schizophrenia is the first efficacy study of March. 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. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:10:09And there's a lot of unmet need out there still today, 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 e g ERP, which has been now validated as a potential biomarker for schizophrenia in these patients. Soumit RoyBiotech Research Analyst at Jones Trading00:10:44Thank you so much again for taking the questions. Thank Soumit RoyBiotech Research Analyst at Jones Trading00:10:48you. Operator00:10:53You, Shumit. 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 BishopAnalyst at BI Research00:11:12Alright. Can you hear me now? Operator00:11:14Yep. That's perfect. Thank you. Tom BishopAnalyst at BI Research00:11:16Alright. Sticking with the schizophrenia trial. You mentioned the longer duration, but I didn't quite understand what that meant. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:11:28So 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 twenty eight days. So it's almost a month. And that what I was referring to that the part b, which includes fifty five patients randomized to placebo or active arm one to one, will give us a probably more solid picture of the drug effect in these patients. Tom BishopAnalyst at BI Research00:12:04Well, I kinda meant how many weeks or months? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:12:07It's four weeks, twenty eight days. Tom BishopAnalyst at BI Research00:12:10Oh, okay. Okay. And can you go into a a little more detail about what the company is doing, you know, pre possible launch of, glorcomazine, in Europe. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:12:26Right. So we have, initiated since JPMorgan multiple discussions with potential partners in discussing if so the drug is available to patients in Europe to move forward quickly with the with the distribution with the access give providing asset access to the drug in Europe. We also have discussions with CROs who also provide us as an alternative confidence in the ability to have Salesforce set up to move forward also in a 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 whoever it maximizes shareholder value will be decision how to progress. But we are on these fronts active on being ready if so, we need to be ready. Tom BishopAnalyst at BI Research00:13:29Okay. That's that's helpful. So, basically, the choice is to to partner with a a major or somebody active in Europe or to go with a, European based clinical sales team. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:13:44That these are the options. That's correct. If so, the drug was approved. Tom BishopAnalyst at BI Research00:13:49Okay. Now what's being used in the schizophrenia trial? That's a three seventy one. So is that a I mean, that's different from glaucomasine. Right? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:14:01That's correct. So ANAVEX three seventy one is a completely different molecule. It comes from a different approach and has different affinities to sigma one receptor. So that is completely independent on of blacamazine, which is called Ganovex two seventy three, and it's the drug which is called blacamazine. So they're two different drugs. Tom BishopAnalyst at BI Research00:14:28Okay. That's fine. Then what are the other countries that might piggyback on a European approval? And then secondly, how are you doing with the FDA, Canada, Australia? Could you cover that? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:14:42Yep. 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 in the Asian region. So this would be a a large number of population as well. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:15:15Regarding 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 this year. Tom BishopAnalyst at BI Research00:15:30So but are you waiting for word from Europe First? Or because I know that the FDA has been kinda a possible, you know, to have a discussion with them. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:15:43That's also the that's also the plan. Correct. So we were 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. Tom BishopAnalyst at BI Research00:15:57But but we're not waiting for the results for for Europe First, or or are we? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:16:04We could we could wait, but it's probably also possible to work in parallel to prepare the discussions. 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 BishopAnalyst at BI Research00:16:31And Are any of those are any of those planned, though, yet? They're still working on it. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:16:37Pardon me? Tom BishopAnalyst at BI Research00:16:38Are any of those, yeah, planned yet? Or, you know, we plan to meet with Canada in next month or, you know, anything like that? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:16:46We will update once we are where 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 relevant out out outcome of this and meaningful outcome, we'll update you. Tom BishopAnalyst at BI Research00:17:06Okay. And and if you're gave, say, an approval in November, just to pick a number, how long would it take for the company to see revenue? In other words, you know, the the launch process. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:17:22So in Europe, it's per the approval is per all the entire European Union, and the sales is done per country. Certain countries, you're allowed to market the next day. In other countries, you need to first reach an agreement when to proceed on the timing of the first sale. So it varies. And so some countries, you can start right away. Tom BishopAnalyst at BI Research00:17:53But you'd be in a position, I mean, to have revenue in the in in the March quarter, are you saying? Or it takes six months to get going? Or Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:18:02I I yep. I cannot foresee right now. There might be some some some logistical questions. But if we are getting close to this, we will be very likely prepared. That's our working assumption. Tom BishopAnalyst at BI Research00:18:18And my last question is where is the drug being manufactured? And do you have a launch inventory? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:18:26We have a large inventory for a launch. That's correct. And the drug is manufactured by the largest US manufacturer. Tom BishopAnalyst at BI Research00:18:33And and is there any tariff impact? It's crazy. But Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:18:38Right. We don't have any visibility on that right now. Tom BishopAnalyst at BI Research00:18:45Okay. Alright. Well, thank you very much. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:18:47Thank you. Operator00:18:51K, Don. There's another question here, doctor Missling. What would be the advantage of oral blarcamesine for patients? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:19:11I think the advantage for the patient for blarcamesine 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. In our case, a patient could be visited by a physician and the patient would be identified as Alzheimer patients right away. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:20:11And the physician would prescribe him blacamazine potentially, and he would, leave with that, prescription for three months and be told to come back three months later. So that's the difference possibly. Operator00:20:26And then there was a follow-up. Is there any difference? I know you kinda touched on it, but the similar advantages to family members or physicians? Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:20:36Yeah. 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, grandfather to the hospital every three weeks or every two weeks, and that's a big problem. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:21:12Regarding 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 vacamazine, 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. And if you delay this, you basically are preventing this to happen. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:22:24So it's important to give the drug to the patients once identified as Alzheimer patient as soon as possible. Operator00:22:35Okay. Thank you very much. I think that's the end of the questions here. So I'll turn it back over to you to close. Christopher MisslingPresident & Chief Executive Officer at Anavex Life Sciences00:22:42Thank 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. Operator00:23:01Thank you, ladies and gentlemen. That'll conclude today's conference call. We appreciate your participation, and you may now disconnect.Read moreParticipantsExecutivesChristopher MisslingPresident & Chief Executive OfficerAnalystsSandra BoenischPrincipal Financial Officer & Treasurer at Anavex Life SciencesSoumit RoyBiotech Research Analyst at Jones TradingTom BishopAnalyst at BI ResearchPowered by