Anavex Life Sciences Q4 2024 Earnings Call Transcript

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December 23, 2024

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.
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Earnings Conference Call
Anavex Life Sciences Q4 2024
00:00 / 00:00

There are 3 speakers on the call.

Operator

Good morning, and welcome to the Anavex Life Sciences Fiscal 2024 4th 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 and A box or raise your hand.

Operator

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 Doctor. Christopher Missling, President and Chief Executive Officer and Sandra Bernisch, Principal Financial Officer. Before we begin, please note that during this conference call, the company will make some projections and forward looking statements.

Operator

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 ks, 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 Doctor.

Operator

Missling.

Speaker 1

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 blakamizant for the treatment of Alzheimer disease, which submission was filed by Anavex last month. The MAA is supported by data from the randomized double blind placebo controlled Phase IIbthree ANAVEX004 trial, and it's up to 144 week open label extension entitled Study ATTENTION AD, investigating Blacomizine in early Alzheimer disease.

Speaker 1

There are an estimated 7,000,000 people in Europe with Alzheimer disease, a number expected to double by 2,030 according to the European Brain Council. The EMA filing acceptance for Blacomazine 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 ATTENTIONED 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 Plaquamizine for the treatment of early Alzheimer disease results from the ANAVEX 2/73 AD004 Phase twothree trial in a medical journal with focus on Alzheimer disease. The publication is expected either within the current or the upcoming quarter.

Speaker 1

Finally, at the end of October, we presented new data from the Phase 2bthree study showing black carmicene once daily orally demonstrates pre specified clinical efficacy through upstream Sigma-1 activation. Clinical data confirmed the mechanism of action by a prespecified sigma1 gene analysis in people with early Alzheimer disease. The data were presented by Marwan Sabak, Professor of Neurology at Barrow Neurological Institute and Chairman of the ANAVEX Scientific Advisory Board at the Clinical Trials on Alzheimer Disease CTAD Conference in Madrid, Spain. With respect to ANAVEX371, also in October, ANAVEX announced encouraging preliminary electroencephalo EEG biomarker results from Part A of the ongoing placebo controlled Phase 2 clinical study of ANAVEX371 for the treatment of schizophrenia. Preliminary results demonstrated a dose dependent effect of ANAVEX371 on 2 key EG biomarkers in patients with schizophrenia.

Speaker 1

ANAVEZ 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 twenty twenty five. 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.

Speaker 2

Thank you, Christopher, and good morning to everybody, and Merry Christmas as well. I'm pleased to share with you today our Q4 financial results for the 2024 fiscal year. Our cash position at September 30 was $132,200,000 and we had no debt. During the quarter, we utilized cash and cash equivalents of $6,700,000 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 4 years.

Speaker 2

During our most recent quarter, general and administrative expenses were $2,800,000 as compared to $2,900,000 in the immediately preceding Q3. Our research and development expenses for the quarter were $11,600,000 as compared to $11,900,000 for the immediately preceding Q3. And lastly, we reported a net loss of $11,600,000 for the quarter or $0.14 per share. Thank you. And now back to you, Christopher.

Speaker 1

Thank you, Sandra. In summary, we are very excited about the potential to advance a novel treatment for early Alzheimer disease with convenient oral dosing. And our team remains deeply committed to executing on our momentum. I'm proud of the strides the analytics team has made in the recent quarter to potentially making a difference for individuals suffering from Alzheimer 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 and A.

Operator

Thank you, Christopher. We'll now begin the Q and A session. 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.

Operator

Hold on one second. Tom, is that you?

Speaker 1

Hello, Tom?

Operator

Yes, 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 I can't make out this question, Christopher. I don't know if you can see this.

Speaker 1

I cannot.

Operator

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

Speaker 1

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

Operator

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?

Speaker 1

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

Operator

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.

Speaker 1

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.

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