2/6/2020

speaker
Anna
Conference Operator

Good afternoon. My name is Anna and I will be your conference operator today. Welcome to the ANAVEX Life Sciences to announce fiscal 2020 first quarter financial results 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. Please go ahead.

speaker
Clint Tomlinson
Conference Call Host

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 first quarter of fiscal 2020 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. Misling and Ms. Boenisch will make prepared remarks and then we will take questions from equity analysts. Before we begin, please know 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 SCC. 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 Misling
President and Chief Executive Officer

Thank you. I'd like to thank everyone for joining us on today's conference call to review our first quarter financial results and share with you some clinical updates for Anavex 273 or Blark Carbamazine. We were pleased to announce earlier this week that the US Food and Drug Administration, FDA, has granted FAST-TRACK designation for the ANAVEX 273 Clinical Development Program for the treatment of Rett Syndrome. FDA FAST-TRACK is a program designed to facilitate and expedite the development and review of a new drug to address unmet medical need in the treatment of a serious and life-threatening condition for which it demonstrates the potential to address unmet medical needs for such a disease or condition. The purpose of the program is to get important new therapies to the patients earlier in order to address the unmet medical needs in the treatment of serious and life-threatening diseases. Our clinical RAD syndrome program, RS001 and RS002, Avatar, are on track with continued enrollment. We continue to strengthen our patent position as well. During the quarter, we were granted another U.S. patent to support Anavex's leading drug candidate, Anavex 273, for the treatment of neurodevelopmental disorders, including Rett syndrome and multiple sclerosis. This patent is expected to remain enforced at least until 2037. not including any patent term extensions. It covers methods of treatment for neurodevelopmental disorders, including Rett syndrome, autism spectrum disorder, Angelman syndrome, and cerebral palsy, among others, and also treatment for multiple sclerosis using Anavex 273. Regarding the Anavex 273 Parkinson's disease dementia study, we were pleased to report that we met our enrollment target for the study. The study enrollment over 100 patients at 20 sites across Spain and 3 sites in Australia. We expect to announce top-line results from this study by mid-2020. Enrollment for the Phase 2b-3 Anavex 273 Alzheimer's Disease study is 50% complete. Recruitment is expected to accelerate given the anticipated international expansion of the study, which will increase the total number of sites from 15 to approximately 45 in 2020. We are reporting advancement of another pipeline compound. We have successfully completed IND-enabling toxicology studies and drug product manufacturing for Anavex 371. Anavex 371 previously received orphan drug designation from the U.S. FDA for frontotemporal dementia, FDD, and initiation of the first phase one clinical trial of Anavex 371 is expected in 2020. 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.

Disclaimer

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