Anavex Life Sciences Corp.

Good morning, everyone, and welcome to the Anovex Life Sciences Fiscal 2023 First 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 the session, if you would like to ask a question, use the Q&A box, or please raise your hand. Note that 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 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. 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 would 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 excited with the continued advancement of our lead product candidate, Anavex 273, in Alzheimer's disease and Rett syndrome, as we maintain our attention on execution across each of our clinical programs and overall business operations. We were very pleased to present top-line data of the randomized, double-blind, placebo-controlled Phase 2b-3 study for the treatment of early Alzheimer's disease at the CTEC Congress 2022 on December 1st. The trial met both co-primary and secondary endpoints, showing statistically significant reduction of clinical decline as measured by those endpoints. We are excited about the data and plan to submit the data for publication in a peer-reviewed medical journal in the near term. As a reminder, Alzheimer's disease represents a growing burden to healthcare systems and societies worldwide. This disease is often multifactorial and complex in nature. We believe that our precision medicine platform and novel central nervous system mechanism improve the chance of clinical success. We are pleased by the results of the placebo-controlled phase 2b-3 Alzheimer's disease trial, which data suggests that Anavex273, placarmazine, an orally available small molecule activator of the upstream sigma-1 receptor, is pivotal to restoring neural cell homeostasis. and promoting neuroplasticity and might be at the forefront of biomarker-guided, pathway-based targeted precision medicine drug development. We look forward to presenting the complete dataset of the study, as well as the other long-term study data of the other programs, including Parkinson's disease, dementia, and Rett syndrome. With a deep portfolio of promising therapies, we believe that Anavex remains well-positioned to address the urgent needs of patients affected by neurodegenerative and rare neurodevelopmental diseases. Going back to the RAD syndrome program, We announced recently on February 2nd last week the completion of enrollment of the randomized placebo-controlled excellence phase 2-3 study for the treatment of patriotic patients with Rett syndrome. We expect to announce top-line results from this study in the second half of this year. In Parkinson's disease dementia, we are planning to announce the data from the 48-week open-label extension of the previously successfully completed Phase II study. In other indications, recent communication with the FDA confirms our strategy to advance Anavex273 for the treatment of fragile leg syndrome. We plan to initiate this trial soon, and we'll share more details about this clinical program in the near term as it becomes available. Further, pipeline expansion of the Anavex platform using gene biomarkers of response applying precision medicine of neurological disorders is expected, including planned initiation of an Anavex 2CM3 imaging-focused Parkinson's disease clinical study sponsored by the Michael J. Fox Foundation, a planned initiation of a phase 2-3 clinical trial for the treatment of a new rare disease indication, and the planned initiation of ANAVEX 371 Phase 2 clinical trial for schizophrenia. And last but not least, we expect several clinical publications involving ANAVEX 273 and ANAVEX 371 and a Rett syndrome burden of illness study. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of ANAVEX, for a brief financial summary of the recently reported quarter.

Thank you, Christopher, and good morning to everyone. We continue to demonstrate operating fiscally responsibly. During our first fiscal quarter, general and administrative expenses were 3.3 million, compared to 3.1 million for the comparable quarter of fiscal 2022. Our research and development expenses for the quarter were 12.1 million, as compared to 8.7 million for the comparable quarter of fiscal 2022. Overall, we reported a net loss of 13 million or 17 cents per share, inclusive of 5.3 million in non-cash compensation items. Our cash position at December 31st, 2022 was 143.6 million. During the quarter, we utilized cash and cash equivalents of 5.8 million to fund our operations. At our current cash utilization rate, we believe we have sufficient cash runway to fund operations and clinical programs beyond the next four years, consistent with pre-guidance in previous quarters. The increase in research and development expenses over the comparable period is primarily related to the expansion of our team and an associated increase in compensation and non-cash charges period over period, as well as costs associated with our Phase 2b-3 study, ANOVAX 273-AD004, and the manufacturer of additional clinical trial supply for upcoming pipeline programs. Thank you, and now back to you, Christopher.