Anavex Life Sciences Corp.

Good morning, everyone. Welcome to the Anovex Life Sciences Fiscal 2022 Fourth 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 raise your hand or use the Q&A box. Please note 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 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 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 are planning to present top-line data of the randomized, double-blind, placebo-controlled phase 2B-3 study, ANAVEX273AD004, for the treatment of early Alzheimer's disease in a late-breaking oral presentation. at the upcoming clinical trials on Alzheimer's disease CTET Congress 2022 on December 1st, 2022 at 4.30 p.m. Pacific time in San Francisco, California. In our Rett syndrome program, we are nearing completion of the randomized placebo-controlled excellence phase 2-3 study for the treatment of patriotic patients with Rett syndrome. We expect to update on the complete enrollment accordingly. Earlier this month, we announced that the FDA granted orphan drug designation to Anavax273 for the treatment of Frederick syndrome. Frederick syndrome is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and over 1 million worldwide. Recent guidance received from the FDA confirms our strategy to advance Anavex 273 for the treatment of Fragile X syndrome in our double-blind, randomized, placebo-controlled Phase 2-3 development program. We will share more details about this clinical program as it becomes available. in August reported a relevant new peer-reviewed publication in the journal Science Translational Medicine titled Widespread Cell Stress and Mitochondrial Dysfunction Occurs in Patients with Early Alzheimer's Disease. This publication provided further scientific evidence of the relevance of sigma-1 receptor activation as a compensatory mechanism to chronic CNS diseases. Further pipeline expansion of the Anifex platform using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need is expected, including Meeting with the FDA to discuss the ANAVEX 273 Parkinson's Disease Program, including a pivotal phase three study. A planned initiation of an ANAVEX 273 imaging-focused Parkinson's Disease clinical trial sponsored by the Michael J. Fox Foundation. A planned initiation of a phase two slash three clinical trial for the treatment of a new rare disease indication. And a planned initiation of ANAVEX 371 phase two clinical trial for schizophrenia. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Arnavex, for a brief financial summary of the recently reported quarter.

Thank you, Christopher, and good morning, everyone. During our fourth fiscal quarter, we reported a net loss of 14.3 million, or 18 cents per share. The reported net loss includes 6 million in non-cash items. Our research and development expenses for the quarter were $11.4 million as compared to $9.4 million for the comparable quarter of fiscal 2021. General and administrative expenses were $3.9 million compared to $2.9 million for the comparable quarter of fiscal 2021. Our cash position on September 30, 2022 was $149.2 million. During the full fiscal year 2022, we utilized cash and cash equivalents of $24.2 million to fund our operations. Within our current cash utilization range, we believe we have a sufficient cash runway to fund operations and clinical programs beyond the next four years. The overall increase in expenses over the comparable period is primarily related to the expansion of our team and an associated increase in non-cash charges period over period. Thank you. And now we'll turn the call back to you, Christopher.