Anavex Life Sciences Corp.

Welcome to the Anovex Life Sciences Fiscal 2021 fourth quarter conference call. My name is Adrienne and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question and answer session. During the question and answer session, if you have a question, please press star then one on your touch-tone phone. Please note this conference call is being recorded. I'll now turn the call over to your host, Clint Tomlinson. Clint, sir, you may begin.

Thank you and good afternoon, everyone. We appreciate you joining us today for Anavex Life Sciences' fourth quarter conference call to review financial results and discuss the company's business updates. A taped replay of this call will be available after the call, and 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 Boenisch, Principal Financial Officer. Following management's remarks, there will be a question and answer session. 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 an 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 really appreciate everyone joining us on today's conference call to review our most recently reported financial results and to provide a business update. We concluded an exceptional fiscal year 2021 while continuing our momentum. highlighted by the efficient execution and full enrollment of three precision medicine clinical trials, including the Phase 2b-3 Anavex 273 clinical trial in Alzheimer's disease, the Avatar 273 clinical trial in Rett syndrome, as well as the Phase 1 study of Anavex 371, starting with our lead drug candidate, 273. We expect top-line results from the second placebo-controlled avatar study for the treatment of our patients with breast syndrome, which are expected to be announced around calendar year end 2021. This study took place in Australia and the United Kingdom using a higher dose than the U.S.-based Phase II study and enrolled 33 patients over a seven-week treatment period, including Onodex273-specific precision medicine biomarkers. Topline results from the placebo-controlled excellence phase 2-3 study for the treatment of patriotic patients with Rett syndrome are expected in the first half of 2022. This phase 2-3 study in patriotic patients with Rett syndrome age 5 to 18 will evaluate the safety and efficacy of 273 in approximately 84 patients over a 12-week treatment period, including 273 specific precision medicine biomarkers. Regarding our Alzheimer's disease program, top-line results from the placebo-controlled Phase II B-3 ANAVEX273-AD004 study for the treatment of Alzheimer's disease are confirmed and are expected in the second half of 2022. The double-blind, placebo-controlled 509-patient late-stage Phase II B-3 study in patients with Alzheimer's disease exceeded enrollment of the targeted patient number of 52 sites across North America, Europe, and Australia using ADAS-COG for cognition and ADCS-ADL for activities of daily living and function as primary endpoints. This multicenter double-blind clinical trial is measuring efficacy, tolerability, and safety of two different once-daily oral 273 doses or placebo. As reported last month, The Independent Data Safety Monitoring Board for the company's Phase 2b-3 study completed its most recent pre-planned review of the preliminary Phase 2b-3 study data in Alzheimer patients. As specified in the protocol, the DSMB reviewed the interim safety data for the 273 Phase 2b-3 under Alzheimer disease clinical study and its open label extension, Attention-AD study. Upon review of the interim safety data, that these will be recommended to continue the study without modification. And we're very excited also to report that the top line data from another pipeline compound, Anavex 371, which had received orphan drug designation by the FDA for thrombosis of blood dementia, a placebo control phase one study in Anavex 371, evaluating Anavex 371 in humans are expected around calendar year end 2021. During 2022, we will also move in closer to further expanding the pipeline for 273 using gene biomarkers of response, applying precision medicine for another neurological disorder with unmet medical needs, including a planned initiation of 273 imaging focus, Parkinson's disease clinical study, a planned initiation also of a phase two slash three clinical trials for the treatment of a new rare disease indication and lastly, a planned initiation of a physical phase 2-3 study in Fragile X syndrome, the most frequent genetic cause of autism spectrum disorder. In Fragile X, we recently announced in August of this year, strong clinical data of 273 in Fragile X syndrome published in the peer-reviewed journal Scientific Reports. The study evaluated 273 in FMR1 knockout mice are validated animal models for the disease, which resulted in the reversal of hyperactivity and restoration of associative learning. Furthermore, 2-7-3 demonstrated dose-dependent sigma-1 receptor occupancy in a positron emission tomography PEP study. And now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer, Self-Linux, for a brief financial summary of the recently reported year-end.