Anavex Life Sciences Corp (AVXL)

[sokol]

The edited transcript of the August 6 conference call is available here: https://www.yahoo.com/news/edited-transcript-avxl-oq-earnings-065349481.html

Here are some tidbits from the conference call (I may have missed something since I did this quickly):

It sounds like Anavex does not the data from the study yet. Missling in commenting about the PDD study said this, in part: "So I think once we have the data, we'll be able to hopefully be very aware of what's going on in this study."

In reference to the type of PDD study:

Question: "So it's very much a signal-seeking study. You don't have any, call it, biases in terms of effect size or anything that you're thinking about?

(Missling) Right. We just want to see a signal first, and that could be however it is, and that would be then -- certainly, we can move from there by sharing with the regulatory bodies and take it from there since it's a highly unmet need since now almost 80% of all Parkinson's patients develop dementia."

Later Missling said this about Anavex reporting the PDD results/data: "We said this quarter. And also, it will definitely be this quarter. I don't want to go in more specifics. We will report exactly when we have the data."

Missling was vague about what would happen after Phase 2 of the PDD study (whether there would be a Phase 3): In terms of your second question, if the Phase II is positive, we would share it with the FDA and then take the steps from there, what would be the right way to approval or the appropriate next step for seeking approval."

But apparently Anavex has information from whatever is done in any extension of any study"

"So we have, in all our studies, an extension. So both the U.S. Rett syndrome study as well as the Parkinson's dementia study have an extension. And so the extension for the Rett syndrome study is 12 weeks in the U.S.; 1 year, the AVATAR study; and it will be also 1 year in the EXCELLENCE study in Rett syndrome; and it's 1 year in the Parkinson's dementia study; and it's 2 years in the Alzheimer's IIb/III study. All these extension studies have not only the biomarker, but also the underlying randomized, placebo-controlled studies have the biomarker, including the genetic analysis included. So we don't have to wait for readout of the extension study to learn about that."

Missling commented about expanding RETT study to Asia/Japan:

Yes. Last question is, do you see -- does one see Rett as being a challenge to Asian communities? And is there any corporate strategy to broaden potential access to those countries through maybe partnering or other endeavors?

There is, indeed, the same amount of Rett patients in Asia, especially in Japan and China, but especially in Japan, there's a same amount of patients there than here in the U.S. So it's around about 10,000 to 15,000 patients in Japan alone. And we do plan, after the readout of the U.S. study, which is forthcoming, to then move into the Japanese territory to also continue the study with ANAVEX 2-73 in Rett patients in that regard.

And would those be studies you conduct? Or do you think it may be best to do that in collaboration with a partner?

(Missling) Right. So Japan is a unique market where the entities working has to be local. So there are probably a mix of a local sponsor with us together or to a 0. We have not made a final decision on that yet.