Anavex Life Sciences Corp.

for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and during this session, if you'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 Anevex's website at .anevex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sandra Burnish, 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 10K and 10Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. And with that, I would like to turn the call over to Dr. Missling.

Thank you, Glenn, 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's disease treatment options, which can be assessed without logistical restrictions. In April, we were pleased to present open label extension data of Blacharmazin for Alzheimer's disease at the ADPD 2025 conference. The data confirmed continued clinically meaningful benefit for early Alzheimer's disease patients. Once daily, oral Blacharmazin demonstrated over three years of continuous treatment, significant amelioration on clinical decline, and shown continued clinically meaningful benefit for early Alzheimer's disease patients. Blacharmazin treated patients continue to accrue benefit through up to four years, as measured by the clinical endpoints -CoC-13 and ADCS-ADL. Last month, Marvin Seback, professor of neurology at Barry Neurological Institute and chairman of Anavex's Life Sciences Advice Report gave an oral presentation titled Oral Blacharmazin, Novel Mechanism for Alzheimer's Disease, Octophagy Restoration through Upstream Sigma-1 Activation, Clinical Efficacy Phase 2b-3 Trial at the ninth 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. With respect to schizophrenia, earlier this month, we announced the successful completion of enrollment in our phase two 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 electro-anthropography, e.g. 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-371 in individuals with schizophrenia. We 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 rising board in April, we announced the appointment of Professor Dr. Audrey Gabel, a specialist of predictive personalized medicine and digital healthcare in Alzheimer's disease and related disorders to the Anavex Scientific Advisory Board. Dr. Gabel is a professor of neurology, neurologist, and doctor in neurosciences at the Memory Resources Research Center. The Rare and Early Dementia Referencing Center and the European Neurodegenerative Excellence Center of Montpellier University, France. Dr. Gabel is also a researcher at the Montpellier Institute of Neurosciences and member of the European Alzheimer Disease Consortium. And now I would like to direct the call to Sandra Bönnisch, Principal Financial Officer of Anavex for a financial summary of the recently reported quarter.

Thank 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 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. 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 13 cents per share. 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 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&A.

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. It looks like our first question is coming from Sermit Roy from Jones Research. I think you can go ahead, Sermit.

Good morning, everyone, and congrats on all the progress. Quick question 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?

Thank you for the question. We expect to have, compared to other regulatory review cycles, that it would probably take about 12 months. 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. 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 really helpful. Second one is for 2025, what do you see as the key inflection points? Is it the 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 would be the bar to beat in these patients.

So thank you for the question. I think the phase two 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 unmade 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 EG-ERP, which has been validated as a potential biomarker for schizophrenia in these patients.

Thank you so much again for taking the questions.

Thank you. Thank you, Schumann. 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.

All right. Can you hear me now?

Yeah, that's perfect. Thank you.

All right. Sticking with the schizophrenia trial, you mentioned a longer duration, but I didn't quite understand what that meant.

So the schizophrenia trial is separated 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. That's what I was referring to, that the part B, which includes 55 patients, randomized to placebo or active arm -to-one, will give us a probably more solid picture of the drug effect in these patients. Well, I kind of meant how

many weeks and months?

It's four weeks, 28 days. Oh, okay.

Okay. And can you go into a little more detail about what the company is doing, you know, pre-possible launch of loracarmicin

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 providing 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 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, whoever maximizes shareholder value will be decision how to progress. But we are on these fronts, active on being ready, so we need to be ready.

Okay, that's helpful. So basically the choice is to partner with a major or somebody active in Europe or to go with a European-based clinical sales team?

These are the options, that's correct. If so, the drug was approved. Okay,

now what's being used in the schizophrenia trial? That's A371. So is that a, I mean, that's different from loracarmicin, right?

That's correct. So Anovex 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 loracarmicin, which is called Anovex 273, and it's the drug which is called loracarmicin. So they're two different drugs. Okay, that's right.

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? Could 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. Regarding UK and Canada, we also are planning to proceed in Australia. We're planning to proceed with starting the respective regulatory bodies in parallel this year.

So, but are you waiting for word from Europe first? Because I know the FDA has been kind of a 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 Europe first, or are we?

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 a first initial discussion with European authorities and led to the feedback to submit.

Are any of those planned, though? Yeah, they're still working on it. Pardon me? Are any of those planned yet? Or, you know, we plan to meet with Canada next month or, you

know, anything like that? We will update once we get feedback. It's too early to provide details on the timing of those discussions. But once we have a relevant outcome of these, a meaningful outcome, we will update you.

Okay. And if Europe gave, say, an approval in November, to pick a number, how long would it take to get the revenue? In other words, you know, the launch process?

Yeah. So in Europe, 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, and 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.

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?

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 my working assumption. 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 US manufacturer.

And is there any tariff impact? It's crazy,

but. Right. We don't have any visibility on that right now.

Okay. All right. Well, thank you very much. Thank you.

Thank you, Tom. There's another question here, Dr. Misling. What would be the advantage of Blarcomazine for patients?

I think the advantage for the patient for Blarcomazine 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. It 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. And the physician would prescribe him Blarcomazine 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.

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 MRI or measure a PET scan. And also there's no impact because of that on the family member's 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. 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 long-term extension study presented at ADPD at the conference, we demonstrated that if you delay the treatment of vacamezin, 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. So it's important to give the drug to the patients once identified as Alzheimer's patient as soon as possible.

Okay, thank you very much. I think that's the end of the questions here. I'll turn it back over to you to close. 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.

Thank you, ladies and gentlemen. That'll conclude today's conference call. We appreciate your participation and you may now disconnect.