Anavex Life Sciences Corp. (NASDAQ:AVXL) Q4 2022 Earnings Conference Call November 28, 2022 8:30 AM ET
Company Participants
Clint Tomlinson - IR
Dr. Christopher Missling - President and CEO
Sandra Boenisch - Principal Financial Officer
Conference Call Participants
Charles Duncan - Cantor Fitzgerald
Soumit Roy - Jones Trading
Yun Zhong - BTIG
Clint Tomlinson
Welcome to the Anavex Life Sciences’ Fiscal 2022 Fourth Quarter Conference Call. My name is Clint Tomlinson, and I’ll be your host for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference is being recorded. The call will also be available for replay on Anavex’s website at www.anavex.com.
With us today is Dr. Christopher Missling, President and Chief Executive Officer; and Sandra Boenisch, Principal Financial Officer.
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. Missling.
Dr. Christopher Missling
Thank you, Clint. We appreciate everyone joining us on today's conference call to review our most recently reported financial results and to provide a business update. We are excited with a continued advancement of our lead product candidate ANAVEX 2-73 in Alzheimer disease and Rett syndrome. As we maintain our attention on execution across each of our clinical programs and overall business operations, we are planning to present top line data of the randomized, double-blind, placebo-controlled Phase 2b/3 study ANAVEX 2-73-AD-004 for the treatment of early Alzheimer disease in a late breaking oral presentation at the upcoming clinical trials on Alzheimer disease, CTAD Congress 2022 on December 1, 2022 at 4:30 PM Pacific Time in San Francisco, California.
In our Rett syndrome program, we are nearing completion of the randomized, placebo-controlled EXCELLENCE Phase 2/3 study for the treatment of paediatric patients with Rett syndrome. We expect to update on the complete enrollment accordingly. Earlier this month, we announced that the FDA granted Orphan Drug Designation to ANAVEX 2-73 for the treatment of Fragile X syndrome. Fragile X syndrome is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the U.S. and over 1 million worldwide. Recent guidance received from the FDA confirms our strategy to advance ANAVEX 2-73 for the treatment of Fragile X syndrome in our double-blind, randomized, placebo-controlled Phase 2/3 development program. We will share more details about this clinical program as it becomes available.