8/6/2020

speaker
Rebecca
Conference Operator

Welcome to the Anne of X Life Sciences to announce fiscal 2020 third quarter financial results conference call. My name is Rebecca and I will be your operator for today's call. At this time, all participants are in listen-only mode. Please note that this conference is being recorded. I will now turn the call over to Clint Tomlinson. Please go ahead.

speaker
Clint Tomlinson
Vice President, Investor Relations

Thank you and good morning, everyone. We appreciate you joining us today for Anne of X Life Sciences conference call and webcast. Dr. Christopher Mislin, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer. Dr. Misling and Ms. Boenisch will make prepared remarks, and then we will 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 forwarding 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 Mislin
President and Chief Executive Officer

Thank you. Thank you, everyone, for joining us on today's conference call to review our third quarter financial results and share with you some clinical updates for Annex 273 or La Camusie. During the last quarter since our last conference call, we have continued to advance our clinical programs with several key milestones accomplished. Just yesterday, we announced having received compassionate use, special access scheme, approval for Alzheimer's disease patients, continued treatment with Anavex 273 by the Australian Government Department of Health, Therapeutics Good Administration TGA, This is certainly an important milestone and we are honored to support medical professionals and their patients seeking treatment for Alzheimer's disease and who have very few medical options. In June, we received approval from both the Canadian and the United Kingdom health authorities to expand the footprint of the International Phase 2B-3 Double-Blind Randomized Placebo-Controlled Safety and Advocacy Trial for the treatment of early Alzheimer's disease into Canada and the UK, respectively. Adding these global regions is expected to continue steadfast or even accelerated enrollment of this important Alzheimer's disease trial while also adding international footprint in North America and Europe. We announced in June the complete enrollment of the ANVEX 273 US Phase II Rett Syndrome trial. The enrollment target was surpassed by 50%. with 31 patients now enrolled in this trial. We expect to announce top-line results from this study in calendar Q4 2020. Furthermore, just last month, we announced that the first patriotic patient was those in the third study of Rett syndrome program, the Excellence Trial. This Phase II-III trial will evaluate the safety and efficacy of Anavex 273 in over 69 patriotic patients with Rett syndrome, age 5 to 18, over a 12-week treatment period, incorporating Anavex 273 specific precision medicine biomarkers. We were also pleased to report in July that the first participant was enrolled in a Phase 1 clinical trial of Anorex 371, which focused on the treatment of frontotemporal dementia , for which Anorex 371 was previously granted orphan drug designation by the FDA. The Phase 1 clinical trial is a prospective double-blind randomized placebo-controlled study. This study will be followed by longer duration dosing including STD patients and incorporating exploratory efficacy in disease biomarker measures. Topline data is anticipated in the first half of 2021. Finally, Parkinson's disease dementia top-line results from the Phase 2 study are forthcoming and are expected to be announced during this fiscal quarter. And now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Annex, for a brief financial summary of the recently reported quarter.

Disclaimer

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