AVXL - NASDAQ

During this session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note that this conference is being recorded. The call will be available for replay on Anavex's website at www.anavex.com. With us today are 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. 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, and the 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, Clint. And good morning, everyone. And Merry Christmas, and Happy New Year very soon, and happy holidays to everybody. Thank you for being with us today to review our most recently reported financial results and provide our quarterly business update. We continue to meaningfully advance our differentiated precision medicine clinical program, highlighted by several recent important announcements and developments. In Alzheimer's disease, this morning, we announced that the European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for Blacamasent for the treatment of Alzheimer's disease. This submission was filed by Anavex last month. The MAA is supported by data from the randomized double-blind placebo-controlled Phase 2b/3 NOVX004 trial and its up to 144-week open-label extension entitled Study Attention ID, investigating Blacamasent in early Alzheimer's disease. There are an estimated seven million people in Europe with Alzheimer's disease, a number expected to double by 2030 according to the European Brain Council. EMA filing acceptance for Blacamasent to review the MAA potentially brings us a step closer to offering broader patient access to a new treatment option in Europe, and we look forward to continued engagement via EMA. Also, recently, Anavex announced its upcoming presentation of top-line long-term data from the Attention AD open-label extension trial at the JPMorgan 2025 Healthcare Conference, taking place January 13 to 16, 2025, in San Francisco, California. In November, Anavex reported the acceptance of a peer-reviewed manuscript titled "Blacamasent for the Treatment of Early Alzheimer's Disease: Results from the Anavex 27380-004 Phase 2/3 Trial" in a medical journal with a focus on Alzheimer's disease. The publication is expected either within the current or the upcoming quarter. Finally, at the end of October, we presented new data from the Phase 2b/3 study showing Blacamasent once daily orally demonstrates pre-specified clinical efficacy through upstream sigma-1 activation. Clinical data confirmed the mechanism of action by a pre-specified sigma-1 gene analysis in people with early Alzheimer's disease. The data was presented by Marvin Sabach, Professor of Neurology at Barrow Neurological Institute and Chairman of the Anavex Scientific Advisory Board, at the Clinical Trials on Alzheimer's Disease (CTAD) conference in Madrid, Spain. With respect to Anavex 371, also in October, Anavex announced encouraging preliminary electroencephalogram (EEG) biomarker results from Part A of the ongoing placebo-controlled Phase 2 clinical study of Anavex 371 for the treatment of schizophrenia. Preliminary results demonstrated a dose-dependent effect of Anavex 371 on two key biomarkers in patients with schizophrenia. Anavex expects data from Part B of the placebo-controlled Phase 2 study, which includes more participants and a longer treatment duration, in the first half of 2025. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for the financial summary of the recently reported quarter.

Thank you, Christopher, and good morning to everybody, and Merry Christmas. I am pleased to share with you today our fourth-quarter financial results for the 2024 fiscal year. Our cash position at September 30th was $132.2 million, and we had no debt. During the quarter, we utilized cash and cash equivalents of $6.7 million in operating activities, after taking into account changes in non-cash working capital accounts. As of fiscal year-end, we anticipate, at the current cash utilization rate, a runway of approximately four years. During our most recent quarter, general and administrative expenses were $2.8 million, as compared to $2.9 million in the immediately preceding third quarter. Our research and development expenses for the quarter were $11.6 million, as compared to $11.9 million for the immediately preceding third quarter. Lastly, we reported a net loss of $11.6 million for the quarter, or $0.14 per share. Thank you, and now back to you, Christopher.

Thank you, Sandra. In summary, we are very excited about the potential to advance a novel treatment for early Alzheimer's disease with convenient oral dosing. Our team remains deeply committed to executing on our momentum. I am proud of the strides the Anavex team has made in the recent quarter of potentially making a difference for individuals suffering from Alzheimer's disease, presenting a scalable treatment alternative alongside the ease of oral administration. I would now like to turn the call back to Clint for the 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 into the Q&A box. The first question is coming from Tom Bishop. Tom, I am putting you on now. I do not see that you came on. Hold on one second. Tom, is that you? Hello, Tom? Yeah. It seems to be some trouble with Tom joining. There is one question from Tom here, Christopher, that I can share with you.

Is the

And I cannot make out this question, Christopher. I do not know if you can see that.

I cannot.

Okay. I think the question is based along the timing of the EMA to make a decision.

Well, this is a 210-day review process, which is standardized, and that is what we expect. And, yep, that is the process from now going forward, I guess. Okay.

Another question that Tom has is that some of the Australian patients have shown remarkable results. Is there any status or update on this?

So we expect an update on the open-label extension study Attention ID, as we said, top-line data during the JPMorgan conference, so we will have an update by then. Okay.

At this point, I do not see any other questions coming in. So I would like to turn that back over to you, Christopher, for any other comments. Thank you very much. And, again, thank you for joining us today.

At the eve of Christmas. 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. And, again, Merry Christmas, happy holidays, and Happy New Year to everybody. Thank you very much.