AVXL - NASDAQ

Good morning, everyone. And welcome to the Anavex Life Sciences Corp. fiscal 2026 first quarter conference call. My name is Clint Tomlinson. 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. During the session, if you would 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 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 current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC, including, without limitation, the company's forms 10-K and 10-Q, to 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. This conference call discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such products will successfully complete clinical development or gain health authority approval. And with that, I would 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 first quarter financial results and quarterly business update. As we enter 2026, we continue to progress our innovative clinical pipeline with a particular focus on our lead candidate, oral blarcamesine, in early Alzheimer's disease. Based on our commitment to improving the lives of patients with neurological disorders, we remain excited about the therapeutic potential of oral blarcamesine. We look forward to working with the regulatory agencies in Europe and in the US to advance blarcamesine as a potential new treatment option for patients. We recently announced Anavex's participation as a key industry partner in Access AD, a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer's disease across real-world clinical settings. The multiyear program is funded by the European Commission's Innovative Health Initiative and unites leading academic centers, technology developers, industry innovators, and patient organizations to strengthen equitable access to timely and effective Alzheimer's disease care. As part of the consortium, blarcamesine will be evaluated in a clinical prediction study. As an update to our regulatory pathway, in January, we announced feedback from an FDA Type C meeting in which the FDA shared their feedback on Anavex's development plans. The meeting discussed the potential pathways to support blarcamesine for Alzheimer's disease. In order to move forward, it is expected that existing data from the Phase 2b/3 Anavex 2-73 AD-004 program be submitted to the FDA. In December, as expected, the CHMP adopted a negative opinion on the marketing authorization application for blarcamesine. Subsequently, on December 18, Anavex announced it had requested the EMA to reexamine its opinion. We are working closely with the EMA during this process, which is being led by a different rapporteur and co-rapporteur. In November, we announced presentations at the 18th CTAD conference in San Diego. The oral late-breaking communication on oral blarcamesine Phase 2b/3 trial confirms identified precision medicine patient population, significant broad clinical and quality of life improvements for early Alzheimer's disease patients, and two poster presentations featuring blarcamesine. Looking forward, we will provide both regulatory and clinical trial updates on blarcamesine in other indications such as Parkinson's disease and fragile X. This will include disclosure of planned future clinical trial designs as we continue to advance our therapeutic pipeline. Additionally, new scientific findings will be presented at upcoming conferences or in upcoming publications. An oral presentation at the 16th Intrinsic Capacity Frailty and Sarcopenia Research Conference for Healthy Longevity to be held March 12 at Johns Hopkins University Bloomberg Center in Washington DC. The new findings on a clinical relationship with a biomarker correlation between clinical endpoints and reduced brain region atrophy with blarcamesine in early Alzheimer's disease. A publication on Alzheimer's disease regarding precision medicine AB-clear populations of the Anavex 2-73 AD-004 Phase 2b/3 trial. Another publication on Alzheimer's disease on the precision medicine gene, collagen 24A1, which with an estimated over 70% prevalence in the early Alzheimer's disease population, has the potential to establish effective treatment of early Alzheimer's disease through the effectiveness of autophagy-enhancing blarcamesine. And a publication regarding fragile X, blarcamesine corrects EEG biomarkers of cortical dysfunction in a mouse model of fragile X syndrome. With regard to Anavex 3-71, we will be advancing Anavex 3-71 towards pivotal clinical studies for the treatment of schizophrenia-related disorders. 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.

Thanks, Christopher. Good morning to everyone. I am pleased to share with you today our first quarter financial results. Our cash position at December 31 was $131.7 million with no debt. During the quarter, we utilized cash and cash equivalents of $7.1 million in operating activities after taking into account changes in non-cash working capital accounts. As of today, we anticipate that at the current cash utilization rate, our cash runway is more than three years. Our research and development expenses for the quarter were $4.7 million as compared to $10.4 million for the comparable quarter of last year. General and administrative expenses were $2.1 million as compared to $3.1 million for the comparable quarter of last year. And compared to the same quarter of fiscal 2025, we saw a decrease in operating expenses, mostly driven by the completion of a large manufacturing campaign of blarcamesine conducted in fiscal 2025, and a decrease in clinical trial activities as a result of the completion of our Anavex 3-71 Phase II study in schizophrenia. And lastly, we reported a net loss of $5.7 million for the quarter or $0.06 per share. Thanks, and I will turn it back to you, Christopher.

Thank you, Sandra. In summary, we are focused on continuing to advance the development of our precision medicine compounds and are excited to be potentially making a difference to individuals suffering from neurological diseases by presenting scalable treatment options alongside the ease of oral administration. I would now like to turn the call back to Clint for Q&A.

Thank you, Christopher. We will now begin the Q&A session. If you have a question, please raise your hand or enter it in the Q&A box. And our first question will come from Ram Selvajara from HC Wainwright. You should be connected now, Ram. But I see you muted. Hello? Can you hear me?

Yes. Thanks so much for taking our questions. Firstly, I was wondering if you could, at this juncture, provide us with some additional information regarding who the rapporteur and co-rapporteur are for the reexamination of the CHMP opinion on blarcamesine.

The 27 countries of the EU decide on two rapporteurs. One of the two countries of the 27 will be rapporteurs.

Okay. Can you provide us with additional information regarding the timeline with which the reexamination is likely to occur? My understanding is that, in effect, it starts a new clock, but that this might be as short as six months. Can you confirm that?

That is correct. It is a sixty plus sixty day period where we respond to the reexamination request. And then the review by the two rapporteurs will take another sixty days. So that's why we stated that we expect this process to last for the first half of this year. Can you provide a timeline regarding when you anticipate potentially filing a formal NDA submission with the FDA? This is a plan we will advance once we are getting closer. But the last meeting was very productive we had with the FDA. And so we continue with this request, which we were given that we will provide the full data package to the FDA for addressing their review and expecting next steps from there.

Can you just remind us what type of meeting this was that you held with the FDA, the most recent one?

That was a Type C meeting.

Okay. Thank you.

Thank you, Ram. Next question comes from Tom Bishop of BI Research. Tom, you should be on now.

Ring. Can you hear me?

Yes. Go ahead.

Can you go into a little bit more detail about what additional information will be in the resubmission to the EMA in terms of will ABC clear data be in there, varying volume data, follow 24A1, and OLE. Can you just give us a little bit more meat on the bone?

That's absolutely possible. So for background, in the resubmission, we are able to address and provide feedback on the arguments why this drug should be reexamined for approval for EMA review. And as a reminder, there is a requirement for granting conditional approval if the disease is serious, if there's a major unmet need, if the data shows clinically meaningful effects, if there's a strong mechanistic rationale especially linking genetic variants, and if the supporting evidence from translational data is available and the sponsor is then also committing to a study in executing it and confirming the efficacy during the approval process. And we are including the data of the AD-004 study, the open-label study, the data on the AB-clear study population, as well as the correlation of the efficacy of the clinical efficacy with the brain atrophy reduction.

Now was none of that actually in the, you know, those last few that you mentioned in the original submission such that this could potentially be more persuasive as it is for me.

Yeah. It's really like a process, I would say, and we also understand that is something which a counterparty has to digest. And maybe that is the reason also we've seen now in the past several cases where even with drugs which were prior approved already, and with very large companies submitting those, you know, trial data, well, ended up at the same situation where we ended up today as well. But, we can, of course, not guarantee the approval in this reexamination procedure. But it seems to be a question of how to repackage or rearticulate the strength of the package or of the data.

Okay. And with the FDA, I know the question was asked when might you file this data with the FDA. I mean, it kinda already exists, so I'm was just wondering if you can be any more clear about why we can't they can't why you can't get that data to the FDA very soon?

It's in process, and you have to also understand the FDA has a certain meeting request which requires some time to schedule. And this is in the process as well. So that's why it's not like you just ship something over, and then you get feedback you have to make it in consistency with a meeting request. And that's what will happen.

Okay. Are there any correct me if I'm getting the scene out here, but are there any trials currently in progress? The only trial we have ongoing is right now the compassionate use program for Rett syndrome. In three countries, in three continents. In Canada, in the UK, in Australia, and we have also the compassionate use ongoing for Alzheimer's disease. So we are planning now the studies in Parkinson's disease, in fragile X, and another indication which is not disclosed yet, and we also will proceed with the Alzheimer trial which we I mentioned before.

Okay. Well, is the it's been a little while since the Rett trial finished, the Parkinson's trial was finished several years now, and I'm just wondering if you can give us any near-term timeline for first trial. Some of these schizophrenia, just wrapped up that.

Yeah.

As to when something we'll we'll we'll get something in this clinic. Yeah. Yep. Absolutely good question. We also plan a schizophrenia program to continue. As I mentioned this morning, so we are really gonna be very busy with trials, and we are very excited about it. And just to let you know, the Parkinson's disease trial has not been started yet. It was Parkinson's disease dementia. But it's the basis of which we are executing the Parkinson's disease trial.

Okay. I guess that's it for me for now. Thank you.

Thank you, Tom. The next question will come from Jesse Silveira from Spirit of the Coast Analytics. You can go ahead, Jesse. Hear me alright?

Yes. Thank you. Hi. Good morning. This is Jesse Silveira with Spirit of the Coast Analytics. Thank you for taking my questions today. Before we get into some of my, I guess, more elaborate questions, maybe we can start with some quicker pitches. First up, something a lot of people have been kind of scratching their heads on is clarity for CHMP rejection, in particular, we know that blarcamesine works better for patients with sigma-1 wild type. As a part of the CHMP rejection, the agency stated, and I quote, the main study failed to demonstrate effectiveness and safety of blarcamesine Anavex, in patients with early Alzheimer's disease who do not have a mutation in the sigma-1 gene, end quote. So this statement appears contrary to the facts because the drug is effective for patients, who do not have a mutation in the sigma-1 gene, also known as sigma-1 wild type. So is it the company's opinion that the CHMP made an error in how they phrased their rejection, or can you clarify the company's understanding of this statement in particular?

Yeah. We would not criticize the regulatory bodies, but we would say that in consistency with our interpretation of the trial, we met the ADAS-cog 13 and there was more significant in the wild type sigma-1 population as well as in the from the boxes which also was superior to the ITT in the wild type compared to the ITT population. The ADL ADCS ADL endpoint, was the only one which was not significant, although it was trending positively. And as we and the academic world found out that this scale is not sensitive enough to pick up the changes of activities of the living in forty-eight weeks in an early Alzheimer's population. So that is the maybe the only difference in interpretation of the trial. That that was, maybe differently evaluated. But now when you go to the AB-clear population, you will see, and we submitted that for publication. It's already publicly available a preprint that the AB-clear population, which includes sigma-1 wild type, carriers with the collagen 24A1 wild type, gene that those patients have significance reached significance across the board. So for ADAS-cog 13, for ADCS ADL, and for CDR Sum of the Boxes. And they're not only achieving significance, but they're also achieved this with highly clinically meaningful effect sizes, which are sometimes two to three times larger than, what we have seen so far from other compounds. In the pipeline or on the market. So that's kind of, like, why this is intriguing now to also point that out and and have that discussion put that forward.

Okay. Thank you for that. And I'm gonna have I'm gonna skip around a minute just because you kind of led into it. So stated in your Borrow Capital interview with Jason a few weeks ago that the reexamination would be under a CMA path and not a full market authorization. And in the interview, you explained that ADCS ADL one of your co-primary endpoints had been invalidated as a reliable measure during your trial analysis phase due to a lack of sensitivity found within the community despite its previous status as the gold standard in Alzheimer's trials. You then went into detail about new statistical methodology that the company was looking to use featuring a higher p-value threshold of 0.0167. And I know that the company has met ADAS-cog 13 and CDR Sum of the Boxes across all genetic cohorts with this p-value or better. So the question is, does using this new threshold allow the company to circumnavigate the ADCS ADL miss, and will regulators in your view, accept the scientific invalidation of ADCS ADL combined with your new gatekeeping strategy? If you can give any on that.

Yeah. As I just stated, this is exactly the discussion which is probably ongoing if this ADL is 4. And if you follow science, you would agree with that. Because it's an endpoint which has been earmarked as being useful for overt Alzheimer, for moderate and severe Alzheimer, but not sensitive enough for the early Alzheimer population. And that was confirmed actually in guidances from the regulatory bodies. So you would assume that that is a fair argument to have, and, we stated that argument and to make that argument as well.

Okay. Thank you for that. And, with that said, you went over the sixty plus sixty day timeline earlier for this reevaluation. We should be, I believe, near sixty days now. Have you already submitted the new strategy and package to CHMP and has a SAG been appointed yet?

We will update everybody once we have the result of this process. We will not comment on the ongoing process. But the SEC will be part of the review process since we requested that, and we will expect this to be given to us a dialogue involving the SAG, the Scientific Advisory Group from the EMA for from the neurology team.

Okay. Thank you. And if I have it correct, you have committed to running a confirmatory phase four trial if approved for CMA using paying patients as a real-world cohort. Isn't is that correct?

Sorry. What patients?

Like, paying patients in the EU. So assuming you are actually approved under CMA, will you be running a phase four trial with these patients? We will. Or how would that look, I guess?

Yeah. We would run a trial as the regulatory body the CHM guidelines, provides for. That you get approved, and then in parallel, you will run a confirmatory study. Yes.

Okay. And I think relevant to additional Alzheimer's trials, is on January 28th of this year, Alzheimer Europe launched the prevalence of dementia in Europe 2025 report which projected a 64% surge in dementia across Europe by 2050. Based on our research, it appears that Europe is not on course to meet projected health strategies, especially those centered on dementia. And it looks like they're kind of, as a as the EU, moving away from social work and dimension favor of defense and economy. In light of these statements, it's our understanding that Anavex is set to participate in Access AD, funded by the European Commission. Can you please give more detail on how blarcamesine, a currently unapproved drug, is to be involved in this program? Like, is the company running this trial? Are endpoints and objectives of this trial? When will the first patient be dosed, or anything else you'd like to offer.

The Access AD program is really a great opportunity for acknowledging Anavex as a participant and being part of the ecosystem in Europe for Alzheimer's disease, which involves both academic institutions as well as government entities and advocacy groups within Europe. So we're very pleased and excited about being part of that. A specific carve-out or not carve-out, especially part of this very large grant, if you like, is a dedicated clinical trial of blarcamesine as a placebo-controlled trial to look for data of prediction of the effect of blarcamesine in Alzheimer patients, in early Alzheimer patients, and that involves, review of biomarkers, and novel biomarkers, looking at autophagy signals, and, also including efficacy. And we're planning to use this trial also for a regulatory, specific, goal. So we will make this trial part of our package for confirming the efficacy of blarcamesine in early Alzheimer's disease. So it's a very intriguing project to be part of. And the Access AD program consists of multiple features. Among them is also a review of healthy diet. Also, a supplement diet is part of that. And, they're all separate. They're not together. And as I just mentioned, one part is explicitly a trial of blarcamesine. In our placebo-controlled clinical trial.

I'm sorry if you mentioned is this an early Alzheimer's patients, or is this is there, like, a preventative component to this trial?

Yeah. So it's a good question. It could end up being a preventative also, but right now, it's consistent with an early Alzheimer's population as a target population.

Okay. And this would be considered AD-006 on your pipeline chart. Is that correct?

That's correct. Yes.

Okay. AD-006. Okay. Great. And I think I'm finishing up here. Is the atrophy to clinical improvement analysis or paper complete? And maybe if you could give any expectations on when we could get eyes on that.

The yeah. So we have submitted now three papers. We I mentioned this morning. And the atrophy paper is still not submitted, but will be submitted soon as well.

Okay. Great. And okay. That's pretty much all I have. Kudos on your JPM presentation and the new website format. They look great. And it's striking how little to lose I think, the CHMP has by granting a CMA considerably considering this, you know, the soundly claimed safety and efficacy the drug on cognition, objective brain atrophy markers, not to mention patient-assessed improvements. Measured by the quality of life AD survey. So we have no further questions, and thank you again for having us.

We appreciate that. Thank you.

Thank you, Jesse.

Doctor Missling, we have no more questions at this time.

Thank you. So in closing, we continue to focus on execution as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions. We are energized by the possibility of making a meaningful impact for people living with neurological diseases offering treatment options that are not only scalable, but also far easier to administer through an oral route. By lowering barriers to access and simplifying delivery, we hope to bring innovative therapies to a broader population and improve quality of life in a tangible way. Thank you.