Anavex Life Sciences Corp.

Good afternoon. My name is Erin, and I will be your conference call operator today. Welcome to the Anovex Life Sciences Fiscal 2021 First Quarter Conference Call. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Clint Tomlinson. Sir, go ahead.

Thank you, and good afternoon, everyone. We appreciate you joining us today for Anovex Life Sciences Conference Call and Webcast. with us today is Dr. Christopher Misling, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer. Dr. Misling and Ms. Boenisch will make prepared remarks, and then we'll take questions from equity analysts. Before we begin, please note that 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 companies 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 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. We appreciate everyone joining us on today's conference call to review our financial results and business updates. I would like to first share with you our recent clinical and pipeline updates. Let me start with Rett Syndrome. Based on recent Phase II US Rett Syndrome clinical trial data, which showed positive clinical activity and safety data, potential accelerated approval strategy planning is underway. There will be progress with ongoing phase 2-3 avatar adult Rett syndrome and phase 2-3 excellence pediatric Rett syndrome studies. At the same time, the FDA has approved an extension of Anavex 273 US Red Syndrome Phase 2 Open Label Extension Study from 12 weeks to 36 weeks. In Australia, Anavex received Compassionate Use Special Access Scheme approval for Red Syndrome patients to continue treatment with Anavex 273 after completing the Avatar Adult Red Syndrome Clinical Extension Study. This is very good news for the patients. and as a reminder, we had previously received compassionate use, special access scheme approval for Alzheimer's disease in Australia. Anavex has sufficient Anavex 273 drug substance available to support all ongoing in-plant clinical trials and first-year commercial launch needs for the Rett syndrome program. and Anavex 273 drug substance in oral solution exhibit excellent chemical stability based upon three years of stability data in both cases. That is very important. Let me now briefly switch to Parkinson's disease. We announced recently that Anavex has been awarded a research grant of nearly $1 million from the Michael J. Fox Foundation for Parkinson's Research. to develop Anavex 273 for the treatment of Parkinson's disease to explore utilization of PEP imaging biomarkers, which demonstrates the continued focus on a potential disease-modifying treatment for Parkinson's disease. As a reminder, our clinical strategy is clearly differentiated from other biopharma companies and clinical studies in central nervous systems. Arnavix is continuing to pioneering the approach of big data in clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analysis of whole exome sequencing and gene expression data in drug development and in particular the potential to identify patients' genetic variants and gene expression changes. that may predict increased chances of success of Rett syndrome, Parkinson's disease, and Alzheimer's disease treatments. Regarding Alzheimer's, a very important scientific finding emerged recently. Researchers at the University of California San Diego have identified the underlying cause of Alzheimer's disease in neurons. They discovered that changes in the structure of chromatin are responsible. Sigma-1 receptor, the direct target which gets activated with Anavex 273, demonstrated to restore chromatin structures. In published experiments, Anavex 273 has been also linked to the prevention and treatment of age-associated diseases through induction of the autophagy cellular recycling process. and Enhanced Protein Clearance in Cell, which is relevant in these diseases. Onomex 273 is currently in a Phase 2 B-3 Alzheimer Disease Clinical Trial utilizing differentiated patient selection criteria and the study is presently over 86% enrolled and randomized. Lastly, Let me also briefly switch to our new clinical pipeline compound, Anavex 371, which is currently in a Phase I and is on track. Independent Data Safety Monitoring Board, DSMB, for the company's Phase I study of its new investigational compound, Anavex 371, also a small molecule activating the Sigma-1 receptor, has completed its recent pre-planned review of the preliminary Phase 1 safety data that DSMB recommended to continue the study without modification.