Anavex Life Sciences Corp.

Good morning. Welcome to the Anovex 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 Anovex's website at www.anovex.com. 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 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 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. Misling.

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 Blakamazine for Alzheimer's Disease is eligible for submission of an application for a union marketing authorization in the EU under the European Medicines Agency centralized procedure. The market authorization would allow direct market access throughout the European Union for oral Blacarmezine for the treatment of Alzheimer's 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 Blacarmezine in Alzheimer 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. Topline data from ANAVEX 273-RA03 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 ANOVAX273RS02 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 Anavex 371, our second clinical small molecule, we were pleased to announce the initiation of the U.S. FDA-cleared placebo-controlled phase 2 trial of Anavex 371 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 ANAVAX273 imaging focus trial and the ANAVAX273 phase 2b-3 six-month trial. For Fragile X, we believe new disease-specific translatable and objective biomarker data generated recently with Anavex 273 should be strengthening the support for the initiation of the potentially pivotal Anavex 273 Phase 2-3 clinical trial in Fragile X. Related to a new rare disease, we are also in preparation to initiate a potentially pivotal Anavex 273 Phase 2-3 clinical trial We are also expecting further peer-reviewed clinical publications involving Anavex 273 and Anavex 371. Last month, we announced a new peer-reviewed publication in Clinical Pharmacology and Drug Development, Bindings from Anavex 371, First in Human Study, which achieved its safety objectives. The publication is entitled Population-Based Characterization of the Pharmacokinetics and Food Effect of Anavex 371, a novel Sigma-1 receptor and allosteric M1 muscarinic receptor agonist in development for treatment for throntodepro-dementia, schizophrenia, and Alzheimer's disease. The publication reports pharmacokinetic dose proportionality of Anavex 371 in humans and food had no effect on the PK of Anavex 371. This is very good news and this data also expands the safety objectives met in this first in-human study of Anavex 371, 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 US patent entitled Neurodevelopmental Disorder Therapy from the United States Patent and Trademark Office. Anovex's newest patent expands coverage of Anovex 273 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 Anovex, for a financial summary of the recently reported quarter.

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 31st 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 11 cents per 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.