Anavex Life Sciences Corp.

Good afternoon. My name is Vanessa, and I'll be your conference call operator today. Welcome to the Anavex Life Sciences fiscal 2020 year end and fourth quarter conference call. As a reminder, this conference call is being recorded. I will now introduce your host of today's conference, Clint Tomlinson. Please go ahead.

Thank you, and good afternoon, everyone. We appreciate you joining us today for Anavex Life Sciences conference call and webcast. Our agenda is to review the company's financial results for its fiscal 2020 year and provide a clinical study update. A taped replay of this call will be available approximately two hours after the call's conclusion and will remain available for one month. 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. Dr. Missling and Ms. Boenisch will make prepared remarks, and then we'll take questions from equity analysts. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements regarding future events. 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 the risks inherent in 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 today, conference call, to review our financial results and clinical updates. First, I would like to provide new key clinical updates. Given the very encouraging data of the U.S. Rett Syndrome Study, we plan to advance the Avatar Adult Rett Syndrome Study into a pivotal Phase II-III clinical trial. In December 2020, Anavex announced top-line results from a U.S. Phase II controlled trial of Anavex 273 in adult female patients with Rett syndrome. Primary safety, pharmacokinetics, and secondary efficacy endpoints were met, with statistically significant and clinically meaningful consistent improvement in Rett syndrome behavior questionnaire RSVQ and clinical global impression improvement. CGI score. Improvements in RSPQ total scores were correlated with decreased improvements in plasma glutamate. Based on these results, we are planning to meet with the FDA to discuss an accelerated approval pathway. Further, we are planning a pipeline extension for 273 using gene biomarkers of response and applying precision medicine for neurological disorders with unmet medical needs. This includes a planned initiation of a pivotal phase 2-3 study in Fragile X syndrome, the most frequent genetic cause of autism spectrum disorder, for which we have convincing preclinical data. We also are planning to initiate a phase 2-3 clinical trial for the treatment of a new rare disease indication. Anavex 371, an orally administered small molecule targeting Sigma-1 and M1 muscarinic receptors that is designed to be beneficial for neurodegenerative diseases, is currently in a Phase I clinical trial and on track with top-line data anticipated in the first half of 2021. Lastly, we plan to initiate an ANAVEX 273 imaging-focused Parkinson's disease clinical study in 2021. Since our last conference call, we reported top-line data of another clinical trial program. Data was presented in November at the CTET 2020 conference. reporting top-line results from the proven concept Phase II placebo-controlled trial with primary objectives of safety, tolerability, and efficacy in cognition of Anavex 273 in patients with Parkinson's dementia compared to placebo. Both primary objectives of the study were met. The results show clinically meaningful dose-dependent and statistically significant improvements in the cognitive drug research computerized assessment system analysis. The study confirmed the precision medicine approach of targeting sigma-1 as a genetic biomarker in response to Anavex 273 and we're planning a pivotal trial of Anavex 273 in Parkinson's disease dementia after submitting the results of the study to the FDA to obtain regulatory guidance. Lastly, in November 2020, Anavex received a notice of allowance from the United States Patent and Trademark Office, USPTO, for its patent application number 16-717-921. expected to remain in force at least until 2037, expanding coverage of treatment methods using its lead drug candidate, 273, as well as drug candidate, 141, for treating a range of neurodevelopmental disorders including Rett syndrome, autism spectrum disorder, Angelman syndrome, cerebral palsy, and multiple sclerosis, among other indications. While 2020 was marked by the outbreak of COVID-19, which has temporarily slowed down activities in many countries in which our trials are taking place, our ongoing clinical trials were able to continue largely uninterrupted in compliance with local regulations and policies. including the enrollment of the Phase 2b-3 Anavex 273 Alzheimer's Disease Study which currently reached over 80% enrollment with complete enrollment expected in early 2021. 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.