Anavex Life Sciences Corp. (NASDAQ:AVXL) Q4 2022 Earnings Call Transcript

Dr. Christopher Missling : Again, I would comment just to recommend to wait for December 1. It’s not a good point today to speculate on that. We are very close. So I think it’s best to discuss it when the data is there. We always know that the FDA responds best when there’s existing data to discuss. So that’s my recommendation.

Yun Zhong : Okay. Then maybe a question on the cash runway guidance. The full year runway is very encouraging. But does that include a potential additional Alzheimer’s study if you need to do another one, please?

Dr. Christopher Missling : Guidance is really based on the historical advancement of our cash utilization rate, which was always very consistent over the last years. So it’s an extrapolation, if you so like. So it’s a conservative extrapolation, so with the increase. And it has definitely all the studies which we have planned to initiate and to execute included in that budget.

Yun Zhong : Okay. Last question to confirm the Parkinson’s disease program. So there is a possibility that the next study that you conduct in Parkinson’s disease will be a pivotal study based on your discussion with the FDA?

Dr. Christopher Missling : We are aiming for that. We have very strong evidence from the PDD study that the effect on MDS-UPDRS, which is the main primary endpoint of this indication has been very favorable with ANAVEX 2-73. So the plan would be to make sure we are able to move forward as quickly as possible. That would mean to aim for a Phase 3.

Clint Tomlinson : I don’t see any further questions at this time. Dr. Missling?

Dr. Christopher Missling : So thank you again. We are very much looking forward, and we’re very excited about the company’s potential as we build on biomarker-driven precision medicine studies with significant unmet medical need and economic burden. And we’re looking forward to clinical trial readouts in autism disease and pediatric Rett syndrome. Thank you.

Clint Tomlinson : Thank you, ladies and gentlemen. This concludes today’s conference call, and we thank you for participating. Have a great week.