Anavex Life Sciences Corp.

Welcome to the Anabex Life Sciences Fiscal 2022 Third Quarter Conference Call. My name is Clint Tomlinson, and I'll 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 also be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Christopher Misling, President and Chief Executive Officer, and Sandra Brunish, 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 NCC. This includes, without limitation, the company's forms 10K and 10Q, 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 results of clinical trials, 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. Misling.

Thank you, Clint. We appreciate everyone joining us on today's conference call to review our most recently reported financial results and to provide a business update. We are pleased with a continued advancement regarding our lead product candidate Anavex 273 in Alzheimer's disease and Rett syndrome, as we maintain our attention on the execution across each of our clinical programs and overall business operations. We achieved a very important milestone at the end of June, with the last patient, last visit in the randomized placebo-controlled Phase IIb-III study of ANAVEX273 for the treatment of early Alzheimer's disease. We are now focused on completion of associated end-of-trial activities in order to provide top-line results of the placebo-controlled Phase IIb-III study of ANAVEX273 in early Alzheimer's disease. which are expected this coming fall. This is an indication which is a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options. As a reminder, Alzheimer's disease is the most common cause of dementia and the fifth leading cause of death in adults older than 65 years. The estimated total healthcare costs for the treatment of Alzheimer's disease in 2020 is estimated at $305 billion, with a cost expected to increase to more than $1 trillion as the population ages. Most of the direct costs of care for Alzheimer's disease are attributed to skilled nursing care, home health care and hospice care. Indirect costs of care, including quality of life and informal caregiving are likely underestimated and are associated with significant negative societal and personal burden. We also recorded the last patient, last visit in the 48 week open label extension of the Parkinson disease dementia phase two study, occurred this quarter. Data from this study is expected by year end 2022. In our Rett syndrome program, completion of the randomized placebo controlled excellence phase two slash three study for the treatment of patriotic patients with Rett syndrome is expected by the end of 2022. In June, Anavex announced a peer-reviewed publication in American Journal of Medical Genetics, identifying a blood biomarker for assessing treatment effect of Anavex 273 in Fragile X syndrome, which provided strong scientific support for the planned clinical trial of Anavex 273 in Fragile X syndrome. End of July, Anavex presented very important data the first entire clinical women Alzheimer's disease and Parkinson's disease gene pathway data from the Annevix 273 PDD-001 Parkinson's disease dementia study at the Alzheimer's Association International Conference AAIC in San Diego, California. Also at AAIC in early August, Anavex presented long-lasting effect of Anavex 371, preventing cognitive decline in a transgenic rat model of Alzheimer's disease. This new data strengthens the importance and applicability of Anavex Precision Medicine's Sigma-1 platform. and is consistent with previously reported therapeutic significant and dose-dependent preclinical prevention of a beta-induced biomarker-correlated cognitive impairment with Anavex 273. Further pipeline expansion of the Anavex platform using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need is expected in 2022, including meeting with the FDA to discuss the Anavex 273 Parkinson disease program, including a pivotal phase three study. Planned initiation of a Anavex 273 imaging-focused Parkinson disease clinical study sponsored by the Michael J. Fox Foundation. And planned initiation of a potential pivotal phase two slash three study in Fragile X syndrome, the most frequent genetic cause of autism spectrum disorder. And planned initiation of a phase two slash three clinical trial for the treatment of a new rare disease indication. And last but not least, planned initiation of Anavex 371 phase two clinical trials for schizophrenia, frontotemporal dementia, and Alzheimer's disease indications. And now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anovex, for a brief financial summary of the recently reported quarter.

Thank you, Christopher, and good afternoon to everyone. During our third fiscal quarter, we maintained fiscally responsible cash utilization as we continue to execute on our clinical programs. Our cash position on June 30th, 2022 was 153.2 million. To put this in context, at our current cash utilization rate and range, we believe we have sufficient cash runway to fund operations and clinical programs beyond the next four years. Our research and development expenses for the third quarter of fiscal 2022 were 9.3 million, as compared to 9 million for the comparable quarter of fiscal 2021. General and administrative expenses were 3.2 million compared to 2.4 million for the comparable quarter of fiscal 2021. Overall, we reported a net loss of 12.4 million for the quarter or 16 cents per share. The overall increased expenses over the comparable period is primarily related to an increase in non-cash compensation charges, period over period, which is driven by the continued addition of staff to manage and support our clinical studies and development. Thank you. And now I will turn the call back over to you, Christopher.