Yahoo Finance Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2024 Earnings Call Transcript
Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2024 Earnings Call Transcript February 7, 2024
Anavex Life Sciences Corp. beats earnings expectations. Reported EPS is $-0.0001, expectations were $-0.14. AVXL isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good morning. Welcome to the Anavex Life Sciences Fiscal 2024 First 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. And during this session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note during this conference – 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 the 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 and 10-Q, which identify the specific factors that may cause actuary 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 would like to turn the call over to Dr. Missling.
Christopher Missling: Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our most recently reported financial results and to provide our quarterly business update. We are poised for a very exciting year for Anavex. In December, the Committee for Medicinal Products for Human Use within the European Medicines Agency agreed to the oral blarcamesine for Alzheimer disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency centralised procedure. The market authorization would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer disease. We are actively engaged on this process and aiming to submit the market authorization application as early as possible in 2024.
Full data from the blarcamesine in Alzheimer’s disease Phase 2/3 randomized clinical trial is forthcoming and will be published in an upcoming peer-reviewed journal. Also, we’d like to mention that the respective open-label extension 96-week trial ATTENTION-AD is ongoing. Top line data from ANAVEX2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial was announced last month. We intend to further assess the results and discuss with the regulatory authorities next steps. A high enrollment rate into the OLE open-label extension of over 91%, as well as the high level of requests for the Compassionate Use Program of 93%, provide solid numerical evidence for the positive real world evidence reported by patients and their caregivers with Rett syndrome under Compassionate Use Authorization.
Previously, we announced the first entire clinical gene pathway data from the ANAVEX2-73-RS-002 AVATAR Rett syndrome trial. We believe that this is the first time a whole genome exome analysis comparing drug and placebo in patients with Rett syndrome was performed, and we believe the results confirm that Rett syndrome is indeed a neurodevelopmental disorder with a key metabolic component, which can be addressed with therapeutic intervention and is likely relevant for other neurodevelopmental diseases as well. Related to ANAVEX3-71, our second clinical small molecule, we were pleased to announce the initiation of the U.S. FDA cleared placebo-controlled Phase 2 trial of ANAVEX3-71 for the treatment of schizophrenia, which is expected to begin in the second quarter of calendar 2024.
Regarding the Parkinson disease program, we are in preparation to initiate the ANAVEX2-73 imaging-focused trial and the ANAVEX2-73 Phase 2b/3 six months trial. For Fragile X, we believe new disease specific translatable and objective biomarker data generated recently with ANAVEX2-73 should be strengthening the support for the initiation of the potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial in Fragile X. Related to a new rare disease, we are also preparation to initiate a potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial. We are also expecting further peer-reviewed clinical publications involving ANAVEX2-73 and ANAVEX3-71. Last month, we announced a new peer-reviewed publication in clinical pharmacology and drug development, findings from ANAVEX3-71, first in human study, which are key achieved its safety objectives.
The publication is entitled population-based characterization of the Pharmacokinetics and Food Effect of ANAVEX3-71, a Novel Sigma-1 receptor and Allosteric M1 Muscarinic Receptor Agonist in development for treatment for Frontotemporal Dementia, Schizophrenia, and Alzheimer disease. The publication reports pharmacokinetic dose proportionality of ANAVEX3-71 in humans and food had no effect on the PK of ANAVEX3-71. This is very good news and this data also expands the safety objectives met in this first in human study of ANAVEX3-71, further supporting its drug development program. And lastly, also last month, we announced the expansion and strengthening of our patent portfolio with the United States Patent and Trademark Office granted a new U.S. patent entitled NEURODEVELOPMENTAL DISORDER THERAPY from the United States Patent and Trademark Office.
Anavex’s newest patent expands coverage of ANAVEX2-73 therapy to ameliorate various conditions associated with loss of function mutations of the gene encoding MeCP2 protein. 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: Thank you, Christopher, and good morning to everyone. I’m pleased to share with you today our first quarter financial results for our 2024 fiscal year. Our cash position at December 31 was $143.8 million. During the quarter, we utilized cash and cash equivalents of $7.3 million to fund operations. At our current cash utilization rate, we believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years. During our most recent quarter, general and administrative expenses were $2.6 million, which is consistent with the immediately preceding fourth quarter of fiscal 2023. Our research and development expenses for the quarter were $8.7 million as compared to $10 million for the most recent fourth quarter of fiscal 2023.
And lastly, we reported a net loss of $8.6 million for the quarter or $0.11 share. Overall, we plan to continue to be fiscally responsible and we believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years. Thank you. Back to you Christopher.
Christopher Missling: Thank you, Sandra. Not only have we demonstrated to continue to be fiscally responsible, but this is also an exciting time for the company and we’re very excited to be entering a new phase of the company’s history with our biomarker driven precision medicine programs. I would now like to turn the call back to Clint for Q&A.
Operator: Thank you, Christopher. We will now begin the Q&A session. [Operator Instructions] Our first question is coming from Jones Research and I’m assuming this will be Soumit Roy.
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