Anavex Life Sciences Corp. Q2 FY2025 Earnings Call

Good morning, everyone, and welcome to the Anavex Life Sciences Fiscal 2025 Second Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note this conference is being recorded. And the call will be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer; and Sandra Boenisch, Principal Financial Officer. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on 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, the need and ability to obtain future capital, and maintenance of intellectual property rights. And with that, I'd like to turn the call over to Dr. 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's disease treatment options, which can be assessed without logistical restrictions. In April, we were pleased to present open-label extension data of blarcamesine for Alzheimer's disease at the AD/PD 2025 conference. The data confirmed continued clinically meaningful benefit for early Alzheimer's disease patients. Once-daily oral blarcamesine demonstrated over three years of continuous treatment, significant amelioration on clinical decline and shown continued clinically meaningful benefit for early Alzheimer's disease patients. Blarcamesine-treated patients continue to accrue benefit, growing up to four years as measured by the clinical endpoints ADAS-Cog13 and ADCS-ADL. Last month, Marwan Sabbagh, Professor of Neurology at Barrow Neurological Institute and Chairman of Anavex’s Life Sciences Advisory Board, gave an oral presentation titled 'Oral Blarcamesine, Novel Mechanism for Alzheimer Disease: Autophagy Restoration through Upstream SIGMAR1 Activation Clinical Efficacy Phase IIb/III Trial' 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. With respect to schizophrenia, earlier this month, we announced the successful completion of enrollment in our Phase 2 clinical study of ANAVEX3-71 for the treatment of schizophrenia. The study has enrolled a total of 71 participants with 16 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 ANAVEX3-71 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 advisory board. In April, we announced the appointment of Professor Dr. Audrey Gabelle, a specialist of predictive, personalized medicine and digital healthcare in Alzheimer's disease and related disorders to the Anavex Scientific Advisory Board. Dr. Gabelle 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. Dr. Gabelle is also a researcher at the Montpellier Institute of Neurosciences and a 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.

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 $0.13 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 scalable treatment alternatives 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. And it looks like our first question is coming from Soumit Roy from Jones Research. I think you can go ahead, sir.

Good morning everyone and congrats on all the progress. A quick question 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.

Thank you for the question. We expect to receive feedback from the regulatory review cycle in about 12 months. We submitted our application in November last year, and it was accepted in December last year. Therefore, it's reasonable to estimate that we will get feedback by the end of this year or early next quarter. I also want to note that we won’t be able to provide interim updates, but we will announce the decision from the EMA once it is finalized.

Got it. That's really helpful. Second one is for 2025, what do you see as the key inflection point? 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 will be the bar to beat in these patients?

So thank you for the question. I think the Phase II study in schizophrenia is the first efficacy study of 3-71. So it's a safety study preliminarily. And we also are focused in the study on the biomarker effect. So we would be very pleased to see an 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, 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 the biomarker effect of the drug in the brain of patients by using 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, Soumit. It looks like our next call comes from Tom Bishop from BI Research. Tom, looks like I think you are active now, but you just need to unmute.

All right. Can you hear me now?

Yes, that's perfect. Thank you.

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

The schizophrenia trial consists of two parts. Part A involved a short period of single ascending doses, while Part B is a longer duration of 28 days. This nearly month-long period, which includes 55 patients randomized to either a placebo or the active arm 121, will likely provide a clearer understanding of the drug's effects in these patients.

Well, I kind of meant how many weeks and months.

It's four weeks, 28 days.

Okay. Okay. And can you go into a little more detail about what the company is doing pre-possible launch of blarcamesine in Europe?

Right. So, we have initiated multiple discussions with potential partners in discussing, if the drug is available to patients in Europe, to move forward quickly with the distribution and providing access to the drug in Europe. We also have discussions with CROs who can provide us with confidence in the ability to have a sales force set up to move forward in an independent way. This would be more advisable from a value creation point of view. So, we like to maximize shareholder value. And the decision that never maximizes shareholder value will be a decision on how to progress. But we are active on being ready, so we need to be prepared.

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 the drug was approved.

Okay. Now, what's being used in the schizophrenia trial? That's A 3-71. So is that different from blarcamesine?

That's correct. So, ANAVEX 3-71 is a completely different molecule. It comes from a different approach and has different affinities to the SIGMAR1 receptor. So, that is completely independent of blarcamesine, which is for ANAVEX 2-73, and it's the drug called blarcamesine. So, there are 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, or Australia? Could you cover that?

Yes. Very good question. So, the other countries that might piggyback on approvals in regions like Europe, EMA would be, I think, the entire rest of the world, South America, Africa, the Middle East, and some countries in the Asian region. So, this would be a large number of populations as well. Regarding the U.K. and Canada, we also are planning to proceed in Australia. We're planning to initiate dialogue with the respective regulatory bodies in parallel this year.

So, are you waiting for word from Europe first, or is it possible to have a discussion with the FDA?

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 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 feedback from the respective authorities. And that's what we did with Europe as well. Remember, we had a first initial discussion with the European authorities that led to the feedback submission.

Are any of those planned, though, yes, they're still working on that?

We will update once we have feedback. It's too early to provide details on the timing of those discussions. But once we have relevant outcomes and meaningful outcomes, we will update you.

Okay. And if Europe 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, the launch process.

Yeah. So in Europe, the approval is for the entire European Union and the sales are done per country. Certain countries allow you to market the next day. In other countries, you need to first reach an agreement on timing for the first sale. So it varies, and in 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 does it take 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 our working assumption.

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 US manufacturer.

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

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

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

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 agnostic procedures, and it would allow for quicker time-sensitive access with continued focus on the individual patient. When we compare this to antibodies, it sometimes takes up to 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. By then, they might move into a different bracket for pathological severity, and they might not even be eligible for that drug anymore. In our case, a patient could be visited by a physician and, once identified as an Alzheimer's patient, the physician would prescribe blarcamesine potentially, and the patient would leave with that prescription for three months and be told to come back three months later. So that's the difference.

Is there any difference in the advantages for family members or physicians?

Yes. So the advantage for the family would be there's less caregiver stress and likely less financial strain. There is no need to arrange for constant transportation to a hospital to measure MRI or better PET scans. Also, there's no impact because of that on the family members own work schedule, which cannot 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 punctures, which are spinal taps, or repeated MRIs. So basically, everybody has fewer 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 AD/PD at the conference, we demonstrated that if you delay the treatment of blarcamesine, you also delay the long-term benefit. So you basically prevent the patient from staying on a better quality of life level, which has implications for dealing with their own life and family interaction. If you delay this, you are preventing this from happening. So it's important to give the drug to the patients as soon as possible once identified as Alzheimer's patients.

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 will conclude today's conference call. We appreciate your participation, and you may now disconnect.