Anavex Life Sciences Q4 2024 Earnings Report

Anavex Life Sciences EPS Results

• Actual EPS: -$0.14
• Consensus EPS: -$0.17
• Beat/Miss: Beat by +$0.03
• One Year Ago EPS: N/A

Anavex Life Sciences Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Anavex Life Sciences Announcement Details

• Quarter: Q4 2024
• Date: 12/23/2024
• Time: Before Market Opens
• Conference Call Date: Monday, December 23, 2024
• Conference Call Time: 8:30AM ET

Anavex Life Sciences (NASDAQ:AVXL) Corp is a clinical‐stage biopharmaceutical company focused on the development of novel therapeutics for central nervous system (CNS) disorders. The company applies a proprietary drug discovery platform that targets sigma‐1 and muscarinic receptors to modulate cellular stress pathways and support neuronal function. Headquartered in New York City, Anavex is dedicated to advancing treatments for neurodegenerative and neurodevelopmental diseases with high unmet medical need.

The company’s lead product candidate, blarcamesine (ANAVEX2‐73), is a small‐molecule activator of the sigma‐1 receptor currently being evaluated in clinical trials for Alzheimer’s disease and Parkinson’s disease dementia. Anavex also holds ANAVEX3‐71, a muscarinic receptor agonist, in its pipeline for Rett syndrome and other developmental disorders. Through these programs, the company aims to demonstrate disease‐modifying effects by addressing underlying cellular dysfunction rather than solely managing symptoms.

Since its founding in 2012, Anavex has completed multiple Phase I and Phase II trials in North America and Europe, collaborating with academic research centers and contract research organizations to support its clinical development. The company has established manufacturing partnerships to ensure supply of clinical‐grade API and plans to expand its trial network into additional regions as programs advance. Christopher U. Missling serves as President and CEO, bringing more than two decades of experience in pharmaceutical research and development. Under his leadership, Anavex continues to explore strategic collaborations and funding opportunities to propel its pipeline toward regulatory milestones.

Anavex Life Sciences Q4 2024 Earnings Call Transcript

Key Takeaways

• The EMA has accepted Anavex’s Marketing Authorization Application for blakamizant in early Alzheimer’s disease, advancing potential European approval.
• Phase 2b/3 data presented at CTAD confirmed pre-specified clinical efficacy of blakamizant through Sigma-1 activation in early Alzheimer’s patients.
• Preliminary Phase 2 EEG biomarker results for ANAVEX371 in schizophrenia showed dose-dependent effects, with Part B data expected in H1 2025.
• Anavex closed Q4 with $132.2 million in cash, no debt, and an estimated 4-year runway at current burn rate.
• The company reported a Q4 net loss of $11.6 million ( $0.14 per share) and used $6.7 million in operating cash.

Presentation

[Clint Tomlinson, Head of Investor Relations at Anavex Life Sciences Corp.]

Good morning and welcome to the Anavex 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 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.

[Clint Tomlinson, Head of Investor Relations at Anavex Life Sciences Corp.]

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, 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.

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

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 blarcamesine 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 its up to 144-week open-label extension entitled study ATTENTION-AD, investigating blarcamesine in early Alzheimer's disease.

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

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. The EMA filing acceptance for blarcamesine 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 ATTENTION-AD open-label extension trial at the J.P. Morgan 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 Blarcamesine for the Treatment of Early Alzheimer's Disease Results from the Anavex 2-73-AD-004 phase 2/3 Trial in a medical journal with focus on Alzheimer's disease.

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

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 blarcamesine 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 Sabbagh, 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 3-71, also in October, Anavex announced encouraging preliminary electroencephalography EEG biomarker results from part A of the ongoing placebo-controlled phase 2 clinical study of Anavex 3-71 for the treatment of schizophrenia. Preliminary results demonstrated a dose-dependent effect of Anavex 3-71 on two key EEG biomarkers in patients with schizophrenia.

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

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 a financial summary of the recently reported quarter.

[Sandra Boenisch, Principal Financial Officer at Anavex Life Sciences Corp.]

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 30 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.

[Sandra Boenisch, Principal Financial Officer at Anavex Life Sciences Corp.]

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.

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

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 make 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.

[Clint Tomlinson, Head of Investor Relations at Anavex Life Sciences Corp.]

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? Hello, Tom. Yeah, it seems to be what it seems to be some trouble with Tom joining. There is one question from Tom here, Christopher, that I can share with you. I can't make out this question, Christopher. I don't know if you can see this.

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

I cannot.

[Clint Tomlinson, Head of Investor Relations at Anavex Life Sciences Corp.]

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

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

So this is a 210-day review process, which is standardized, and that's what we expect. And yeah, that is the process from now going forward, I guess.

[Clint Tomlinson, Head of Investor Relations at Anavex Life Sciences Corp.]

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?

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

We expect update on the open-label extension study ATTENTION-AD, as we said, top-line data during J.P. Morgan Conference. We will have an update by then.

[Clint Tomlinson, Head of Investor Relations at Anavex Life Sciences Corp.]

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.

[Christopher U. Missling, CEO at Anavex Life Sciences Corp.]

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.

Participants

Executives

• Clint Tomlinson, Head of Investor Relations
• Christopher U. Missling, CEO

Analysts

• Sandra Boenisch, Principal Financial Officer at Anavex Life Sciences Corp.