8/12/2021

speaker
Adrienne
Conference Call Operator

Good afternoon. My name is Adrienne, and I'll be your conference call operator today. Welcome to the Anne of Ex Life Sciences Fiscal 2021 Third Quarter Conference Call. As a reminder, this conference call is being recorded. I'd like to call over your host for today's conference, Clint Tomlinson. Please go ahead.

speaker
Clint Tomlinson
Host

Thank you, and good afternoon, everyone. We appreciate you joining us today for Anne of Ex Life Sciences Third 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. 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 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.

speaker
Dr. Christopher Missling
President and Chief Executive Officer

Thank you, Clint, and we appreciate everyone joining us on today's conference call to review our financial results and describe the company's growth strategy. Let me start by stating that we can proceed into the remainder of 2021 with a background of a strong balance sheet of over 157 million in cash and no debt. Starting with our lead drug candidate, Anavex 273, We expect to announce top-line results from the confirmatory, double-blind, placebo-controlled, late-stage Phase IIb-III study in Alzheimer's disease in second half 2022. The double-blind, placebo-controlled, 509-patient, late-stage Phase IIb-III Anavex 273 trial in patients with Alzheimer's disease exceeded enrollment beyond 450 patients at 52 sites across North America, Europe, and Australia using ADAS-COG cognition and ADCS-ADL 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 anorexia Anabix273 is an orally available small molecule activator of the Sigma-1 receptor. Data suggests that activation of Sigma-1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promote neuroplasticity. The study includes a pre-specified Precision Medicine Biomarker, SIGMA-1 gene expression, which demonstrated correlation with direct measures of clinical benefit, cognition, and activities of daily living, and found correlation in a previous case to Alzheimer's disease. Patent data previously confirmed dose-dependent target engagement of SIGMA-1 with Anavex 273. As a reminder, of our clinical strategy is clearly differentiated from other biopharma companies. In clinical studies in CNS, Anavex is continuing to pioneer 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 patient genetic variants and gene expression changes that may predict increased chances of success of Alzheimer's disease, Parkinson's disease and Rett syndrome treatments. Additionally, we can announce that we exceeded the enrollment target for the precision medicine under VEX 273 Phase 2-3 Avatar clinical trials in patients with Rett syndrome. and currently top-line results from this study are expected in the second half of 2021. Further clinical milestones are provided in Adavex Life Sciences' latest corporate presentation, available at www.adavex.com. And now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Adavex, for a brief financial summary of the recently reported quarter.

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