5/7/2020

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 X Life Sciences Fiscal 2020 Second Quarter Financial Results Conference Call. As a reminder, this conference call is being recorded. I'd now like to turn the call over to 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 X Life Sciences Conference Call and Webcast. Our agenda is to review the company's financial results for its second 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 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 FCC. 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 those forward-looking statements. These factors may include, without limitation, risks inherent in the development 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. Thank you, everyone, for joining us on today's conference call to review our second quarter financial results and share with you some clinical updates for Anavex 273 or black carmezine. Much has changed around all of us since our last quarterly conference call. As the world navigates COVID-19, Anavex's paramount obligation has always been to ensure the safety of all participants in its clinical programs and the integrity of the studies in which they participate. We are responding to regulatory, institutional, and government guidance in policies related to COVID-19. We remain focused on our clinical development plans and are working closely with all stakeholders to try to mitigate the effect of COVID-19 on companies ongoing clinical trials for Rett syndrome, Parkinson's disease, dementia and Alzheimer's disease. Clinical sites continue to operate and see patients where possible in accordance with local regulations and site policies, regulatory, institutional and government guidance related to COVID-19. Clinical sites continue to screen and enroll patients into the active trials and the respective open-label extensions for the two Phase II Rett Syndrome trials and the Phase IIb-3 Alzheimer's disease trial, while the Parkinson's disease dementia Phase II trial has completed enrollment and we expect to announce top-line results from this study by mid-2020. Anavex proactively continues to bring on sites in new countries across programs depending on the situation in each country of operation. While Rett syndrome protocols had always by default allowed at-home visits, US FDA, European EMA, and Australian PGA recommended contingency plans are actively in place for the Alzheimer's Disease Phase II B-3 study and the Parkinson's Disease Dementia Phase II study to ensure remote or virtual assessments for active patients and all respective extension studies. Because Anavex 273 is an oral formulation, study participants are able to receive shipments of their study medication in a controlled and compliant fashion, and direct-to-patient delivery is occurring in multiple countries. We understand that some activities will be temporarily slower because of COVID-19. However, our risk mitigation actions were implemented for every project Our primary focus is on the safety of all involved and the continued conduct of our clinical programs as we navigate the pandemic together. Our sites understand why their patients participate in research and are committed to the importance of clinical trials for those patient communities currently without effective treatments. 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

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-