Anavex Life Sciences Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 13, 2025

Key Takeaways

  • Open-label extension data for blacaramazine demonstrated up to four years of continuous treatment benefit in early Alzheimer’s patients, with significant slowing of clinical decline on COG13 and ADCS-ADL measures.
  • Enrollment in the Phase II schizophrenia trial of ANAVEX 3-71 is complete (71 participants), and top-line safety, biomarker, and efficacy data are expected in the second half of 2025.
  • Anavex ended Q2 FY2025 with $115.8 million in cash, no debt, and projects a cash runway of approximately four years at the current burn rate.
  • Preparations for a potential European launch of blacaramazine are underway, with EMA feedback anticipated by year-end or early next quarter and parallel discussions planned with other global regulators.
  • For Q2 FY2025 Anavex reported a net loss of $11.2 million ($0.13 per share), with R&D expenses of $9.9 million and G&A expenses of $2.6 million.
AI Generated. May Contain Errors.
Earnings Conference Call
Anavex Life Sciences Q2 2025
00:00 / 00:00

Transcript Sections

Skip to Participants
Operator

For 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.

Operator

With 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.

Operator

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 doctor Misling.

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

The 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

Capelle 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 Boenisch
Principal Financial Officer & Treasurer at Anavex Life Sciences

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 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 Boenisch
Principal Financial Officer & Treasurer at Anavex Life Sciences

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 $2,600,000 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 Boenisch
Principal Financial Officer & Treasurer at Anavex Life Sciences

And now I will turn the call back over to Christopher.

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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 and A.

Operator

Thank 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 Roy
Biotech Research Analyst at Jones Trading

Good 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

So 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 Roy
Biotech Research Analyst at Jones Trading

Got 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

So 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

And 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 Roy
Biotech Research Analyst at Jones Trading

Thank you so much again for taking the questions. Thank you.

Operator

You, 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 Bishop
Analyst at BI Research

Alright. Can you hear me now?

Operator

Yep. That's perfect. Thank you.

Tom Bishop
Analyst at BI Research

Alright. Sticking with the schizophrenia trial. You mentioned the longer duration, but I didn't quite understand what that meant.

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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 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 Bishop
Analyst at BI Research

Well, I kinda meant how many weeks or months?

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

It's four weeks, twenty eight days.

Tom Bishop
Analyst at BI Research

Oh, 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

Right. 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 Bishop
Analyst at BI Research

Okay. 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

That these are the options. That's correct. If so, the drug was approved.

Tom Bishop
Analyst at BI Research

Okay. 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

That'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 Bishop
Analyst at BI Research

Okay. 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

Yep. 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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 this year.

Tom Bishop
Analyst at BI Research

So 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

That'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 Bishop
Analyst at BI Research

But but we're not waiting for the results for for Europe First, or or are we?

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

We 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 Bishop
Analyst at BI Research

And Are any of those are any of those planned, though, yet? They're still working on it.

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

Pardon me?

Tom Bishop
Analyst at BI Research

Are 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

We 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 Bishop
Analyst at BI Research

Okay. 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

So 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 Bishop
Analyst at BI Research

But 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

I 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 Bishop
Analyst at BI Research

And my last question is where is the drug being manufactured? And do you have a launch inventory?

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

We have a large inventory for a launch. That's correct. And the drug is manufactured by the largest US manufacturer.

Tom Bishop
Analyst at BI Research

And and is there any tariff impact? It's crazy. But

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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

Tom Bishop
Analyst at BI Research

Okay. Alright. Well, thank you very much.

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

Thank you.

Operator

K, Don. There's another question here, doctor Missling. What would be the advantage of oral blarcamesine for patients?

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

I 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

And 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.

Operator

And 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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, grandfather to the hospital every three weeks or every two weeks, and that's a big problem.

Christopher Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

So it's important to give the drug to the patients once identified as Alzheimer patient as soon as possible.

Operator

Okay. 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 Missling
Christopher Missling
President & Chief Executive Officer at Anavex Life Sciences

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.

Operator

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

Executives
Analysts
    • Sandra Boenisch
      Principal Financial Officer & Treasurer at Anavex Life Sciences
    • Soumit Roy
      Biotech Research Analyst at Jones Trading
    • Tom Bishop
      Analyst at BI Research
Powered by Quartr