Anavex Life Sciences Corp.

Good morning, and welcome to the Anovex Life Sciences Fiscal 2024 Fourth 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. 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 Anovex's website at www. With us today is Dr. Christopher Misling, 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 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, 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, 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. 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 to 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 Blacamycin for the treatment of Alzheimer's disease, which submission was filed by Anavex last month. The MAA is supported by data from the randomized double-blind placebo-controlled phase 2b-3 ANAVEX-004 trial, and it's up to 144-week open-label extension entitled Study Attention AD, investigating black carmesine in early Alzheimer's disease. There are an estimated 7 million people in Europe with Alzheimer's disease, a number expected to double by 2030, according to the European Brain Council. The EMA filing acceptance for black carmesine 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 with the EMA. Also recently, Anavex announced its upcoming presentation of top-line long-term data from the AttentionAD Open Label Extension Trial at the J.P. Morgan 2025 Healthcare Conference, taking place January 13-16, 2025 in San Francisco, California. In November, Anavex reported the acceptance of a peer-reviewed manuscript titled Black Hamazin for the Treatment of Early Alzheimer Disease Results from the Anavex 273AD004 Phase 2-3 Trial in a medical journal with 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 black carmesine once daily orally demonstrates pre-specified clinical efficacy through upstream Sigma-1 activation. Clinical data confirmed the mechanism of action by pre-specified Sigma-1 gene analysis in people with early Alzheimer's disease. The data were presented by Marwan Sabag, Professor of Neurology at Barrow Neurological Institute and Chairman of the Anavex Scientific Advisory Board at the Clinical Trials on Alzheimer's Disease CTET conference in Madrid, Spain. With respect to Anavex 371, also in October, Anavex announced encouraging preliminary electroencephalo-EG biomarker results from Part A of the ongoing placebo-controlled Phase II clinical study of Anavex 371 for the treatment of schizophrenia. Preliminary results demonstrated a dose-dependent effect of Anavex 371 on two key EEG biomarkers in patients with schizophrenia. Anavex expects data from Part B of the placebo-controlled Phase II 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 a financial summary of the recently reported quarter.

Thank you, Christopher, and good morning to everybody, and Merry Christmas as well. I'm 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. And 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. And lastly, we reported a net loss of 11.6 million for the quarter or 14 cents 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, and our team remains deeply committed to executing on our momentum. I'm proud of the strides the Anavex team has made in the recent quarter to potentially making a difference for individuals suffering from Alzheimer's disease 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. We'll now begin the Q&A session. If you have a question, please raise your hand or enter it into the Q&A box. And the first question is coming from Tom Bishop. Tom, I'm putting you on now. Tom, I don't see that you came on. Hold on one second. Tom, is that you?

Yeah. 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 uh yeah i can't i can't make out this question christopher i don't know if you can see this i cannot OK. I think the question is based along the timing of the EMA to make a decision.

So this is a 210 days review process, which is standardized. And that's what we expect. And yeah, 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 improvement. Is there any status or update on this?

So we expect update on the open label extension study attention AD, as we said, top line data during JPMorgan conference. So we will have an update by then.

okay at this point i don't 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 well as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions. And again, Merry Christmas and Happy Holidays and Happy New Year to everybody. Thank you very much.

And with that, that closes the call again, please.