Anavex Life Sciences Corp.

Good morning, and welcome to the Anovex Life Sciences Fiscal 2023 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 use the Q&A box or raise your hand. Please note that this conference is being recorded, and 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 the 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 material 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'd 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 give our quarterly business update. We are very excited to be entering a new phase of the company's history. For the first time, we initiated the process of submitting a marketing authorization application to the European Medicines Agency, EMA, for Blacarmazine related to the treatment of Alzheimer's disease. Relatedly, we are starting to explore possible commercial activities and examining innovative strategies to effectively engage patients, providers, and payers. There's a high demand for Alzheimer's disease patients and families for easy access and scalable treatment options. We are striving to work towards presenting a drug that will potentially improve patients' lives with our precision medicine oral Blacarmazine, which is intended to reduce the need for complex procedures for the treatment of people with Alzheimer's disease. According to the European Brain Council, there are an estimated 7 million people in Europe with Alzheimer's disease, a number expected to double by 2030. Full data from the Black-Chamisine Phase 2B-3 Randomized Clinical Trial in Alzheimer's Disease will be published in an upcoming peer-reviewed journal. Also, the respective open-label extension 96-week trial attention AD is ongoing. Regarding RAD syndrome, we are on track for top-line data of potentially pivotal Anavex 273 RS003 Phase 2-3 Excellence Pediatric Clinical Trial. Regarding the Parkinson's disease program, we are in preparation to initiate the Anavex 273 imaging focus trial and the Anavex 273 phase 2B slash 3 six-month trial. Related to schizophrenia, we are in preparation to initiate the phase 2 clinical trial with Anavex 371, our second clinical stage small molecule. Respect to FRED-ALEX, we are in preparation to initiate a potentially pivotal ANAVEX273 Phase 2-3 clinical trial. And related to a new rare disease, we are in preparation to initiate a potentially pivotal ANAVEX273 Phase 2-3 clinical trial. We are also expecting further peer-reviewed clinical publications involving ANAVEX273 and ANAVEX371. In October, we announced a new peer-reviewed publication in the journal Neurobiology of Aging, titled Early Treatment with an M1 and Sigma-1 Receptor Agonist Prevents Cognitive Decline in a Transgenic Red Model Displaying Alzheimer-like Amyloid Pathology, featuring the orally available small molecule Anavex 371. This preclinical study describes the potential disease modifying properties of Anavax-371 on Alzheimer's disease pathology as a possible drug candidate for one's daily oral preventative strategy for Alzheimer's disease. And lastly, this month, we announced the expansion and strengthening of our patent portfolio with the United States Patent and Trademark Office, USPTO, granting US patent number 11813242 entitled A2-73 as a therapeutic for insomnia, anxiety, and agitation. This patent expands Anavax's existing patent coverage of Blacarmezine, including US patent number 11337953, to cover Anavax's leading drug candidate, Blacarmezine, Anavax 141, and Anavax 9144, for treating insomnia, anxiety, or agitation. This granted US patent is another important milestone in protecting the commercial potential of Blacarmazine and Anavex's other lead compounds, with a practical value of delivering holistic care for patients with Alzheimer's disease, dementia, or Parkinson's disease. And now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Aravex, for a financial summary of the recently reported quarter.

Thank you, Christopher, and good morning, everyone. I am pleased to share with you today our fourth quarter financial results. Our cash position on September 30th was 151 million. During the quarter, we utilize cash and cash equivalents of 5.8 million to fund our 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 compared to 3.2 million last quarter. Our research and development expenses for the quarter were 10 million as compared to 10.3 million for the last quarter. And lastly, we reported a net loss of 10.1 million for the quarter or 12 cents per share. Overall and in summary, 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 and now back to you, Christopher.