Downing v. Anavex Life Sciences Corporation — Entry #23: DECLARATION of Theodore L

Case: Downing v. Anavex Life Sciences Corporation nysd · 1:24-cv-03529

filed May 08, 2024

What this document is

Docket entry #23 · filed August 23, 2024

DECLARATION of Theodore L. Kornobis in Support re: 22 MOTION to Dismiss .. Document filed by Anavex Life Sciences Corporation, Christopher U. Missling. (Attachments: # 1 Exhibit Form 10-K, # 2 Exhibit Form 10-K, # 3 Exhibit Press Release, # 4 Exhibit Transcript, # 5 Exhibit Presentation, # 6 Exhibit Report, # 7 Exhibit Earnings Call, # 8 Exhibit Transcript, # 9 Exhibit Press Release, # 10 Exhibit Press Release, # 11 Exhibit Press Release).(Kornobis, Theodore) (Entered: 08/23/2024)

Who is involved

Anavex Life Sciences Corporation
Christopher U. Missling
Kenneth Downing

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We follow this case because it names a company we track, although that company is not a party:

CleanSpark: its name “CleanSpark, Inc.” appears in a filing in this case.
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Case 1:24-cv-03529-CM Document 23-7 Filed 08/23/24 Page 1 of 16

Case 1:24-cv-03529-CM Document 23-7 Filed 08/23/24 Page 2 of 16

Anavex Life Sciences Corp.
NasdaqGS:AVXL
FQ1 2022 Earnings Call Transcripts
Wednesday, February 09, 2022 9:30 PM GMT
S&P Global Market Intelligence Estimates
-FQ1 2022- -FQ2 2022- -FY 2022- -FY 2023-

CONSENSUS ACTUAL SURPRISE CONSENSUS CONSENSUS CONSENSUS

EPS Normalized (0.16) (0.14) NM (0.18) (0.76) (0.65)

Revenue (mm) 0.00 0.00 0.00 0.00 0.00 7.52
Currency: USD
Consensus as of Feb-07-2022 3:09 PM GMT

- EPS NORMALIZED -

CONSENSUS ACTUAL SURPRISE

FQ2 2021 (0.15) (0.12) NM

FQ3 2021 (0.14) (0.14) NM

FQ4 2021 (0.14) (0.15) NM

FQ1 2022 (0.16) (0.14) NM

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Case 1:24-cv-03529-CM Document 23-7 Filed 08/23/24 Page 3 of 16
Contents

Table of Contents

Call Participants .................................................................................. 3
Presentation .................................................................................. 4
Question and Answer .................................................................................. 7

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ANAVEX LIFE SCIENCES CORP. FQ1 2022 EARNINGS CALL | FEB 09, 2022

Call Participants
EXECUTIVES

Christopher U. Missling
President, CEO, Secretary &
Director

Clint Tomlinson
VP of Corporate

Sandra Boenisch
Principal Financial Officer &
Treasurer

ANALYSTS

Charles Cliff Duncan
Cantor Fitzgerald & Co., Research
Division

Soumit Roy
JonesTrading Institutional
Services, LLC, Research Division

Tom Bishop
BI Research

Xu Zou

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ANAVEX LIFE SCIENCES CORP. FQ1 2022 EARNINGS CALL | FEB 09, 2022

Presentation
Clint Tomlinson
VP of Corporate
Good afternoon. Welcome to the Anavex Life Sciences Fiscal 2022 First Quarter Conference Call. My
name is Clint Tomlinson, and I will be your host for today's call. [Operator Instructions] Please note
that this conference is being recorded. The call will 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, our
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 even 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 would like to turn the call over to Dr. Missling.
Christopher U. Missling
President, CEO, Secretary & Director
Thank you, Clint, and we appreciate everyone joining us on today's conference call to review our most
recently reported financial results and to provide a business update. The first quarter marked significant
progress across our portfolio, highlighted by the positive top line results of the randomized placebo-
controlled AVATAR Phase III study for the treatment of adult patients with Rett syndrome and the positive
top line results from the placebo-controlled Phase I study of ANAVEX 3-71, which is in development for
the treatment of neurodegenerative diseases, including FTD, frontotemporal dementia; and a clinical data-
driven evidence of efficacy and safety of our broad SIGMAR1 platform portfolio, which allows us to plan
and to expand further into the rare disease space, including implementing expanded access for adult
patients with Rett syndrome, an underserved population.

At the same time, we are advancing both ANAVEX 2-73 and ANAVEX 3-71 in the planned studies with a
goal to driving meaningful growth across our broad SIGMAR1 platform portfolio to deliver transformational
treatments for patients with both degenerative and developmental neurological disorders around the
world.

Starting with our lead drug candidate, 2-73. We reported positive top line results from the second
randomized placebo-controlled AVATAR Phase III study for the treatment of adult patients with Rett
syndrome. The study met its primary and secondary efficacy and safety endpoints with consistent and
clinically meaningful improvements in all efficacy measures of Rett syndrome symptoms.

Convenient once-daily oral liquid doses of up to 30 milligram of ANAVEX 2-73 were also well tolerated with
good medication compliance. Based on the results of the AVATAR Phase III study and the prior successful
U.S. Phase II study in adult patients with Rett syndrome, Anavex is now planning to meet with the FDA to
discuss the approval pathway.

Top line results from the placebo-controlled EXCELLENCE Phase II/III study for the treatment of pediatric
patients with Rett syndrome are expected in second half of 2022. The extension of this expected -- or
the expected duration of enrollment is based on recent country and local government requirements for

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children to have full COVID-19 vaccination prior to joining a clinical trial, which includes our pediatric
EXCELLENCE trial.

This Phase II/III study in pediatric patients with Rett syndrome aged 5 to 17 will evaluate the safety and
efficacy of 2-73 in approximately 84 patients over a 12-week treatment period, including ANAVEX 2-73
specific precision medicine biomarkers.

Regarding our Alzheimer's disease program, top line results from the randomized placebo-controlled Phase
IIb/III ANAVEX 2-73-AD-004 study for the treatment of Alzheimer's disease are also expected in the
second half 2022. The 509 patients, late-stage Phase IIb/III study in patients with Alzheimer's disease
is taking place at 52 sites across North America, Europe and Australia, using ADAS-Cog for cognition and
ADCS-ADL for activities of daily living and function as primary endpoints.

This clinical trial is measuring efficacy, tolerability and safety of 2 different once-daily oral 2-73 doses
or placebo. The current data allows us to expand in parallel our Anavex platform pipeline using gene
biomarkers of response, applying precision medicine for neurological disorders with unmet medical needs,
which are expected in 2022.

That includes the planned initiation of ANAVEX 2-73 imaging-focused Parkinson's disease clinical study;
a planned initiation of a potential pivotal Phase II/III study in Fragile X syndrome, the most frequent
genetic cause of autism spectrum disorder; and a planned initiation of a Phase II/III clinical trial for
the treatment of a new rare disease indication. As well, last month, Anavex reported positive top line
results from the placebo-controlled Phase I ANAVEX 3-71 clinical trial in development for the treatment of
neurodegenerative diseases, including FTD, frontotemporal dementia, for which ANAVEX 3-71 has been
granted orphan drug designation by the FDA.

The study reached primary and secondary endpoints of safety with no serious adverse events or dose-
limiting toxicity observed. ANAVEX 3-71 was well tolerated in all cohorts receiving ANAVEX 3-71 in single
doses ranging from 5-milligram to 200-milligram daily with no serious adverse events and no significant
lab abnormalities in any subject.

Based on these results in ANAVEX 3-71's preclinical profile, we intend to advance 3-71 into a biomarker-
driven clinical development dementia program for the treatment of FTD, frontotemporal dementia,
schizophrenias and Alzheimer's disease, evaluating longitudinal effect of treatment with ANAVEX 3-71. We
believe that the results of these studies could serve as the basis for advancing into respective registration
studies in the U.S.

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.
Sandra Boenisch
Principal Financial Officer & Treasurer
Thank you, Christopher, and good afternoon to everyone on the call. Our cash position at December
31, 2021, was $151.1 million, which we believe is sufficient cash runway to fund operations and clinical
programs beyond 2025.

For the first quarter, cash utilized in operations was $3.5 million. We reported a net loss of $10.9 million
for the quarter or $0.14 per share, inclusive of noncash compensation charges of $3.9 million compared
to net loss of $7.9 million or $0.12 per share, inclusive of noncash compensation of $0.9 million for the
comparable quarter of fiscal 2021.

Our research and development expenses for the first quarter of fiscal 2022 were $8.7 million as compared
to $7.9 million for the first quarter of fiscal 2021. General and administrative expenses were $3.1 million
compared to $1.5 million for the comparable quarter of fiscal 2021.

In both cases, the increases are primarily related to an increase in noncash compensation charges of
$1.7 million for research and development and $1.3 million for general and administrative expenses

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ANAVEX LIFE SCIENCES CORP. FQ1 2022 EARNINGS CALL | FEB 09, 2022

period-over-period. These increases in noncash compensation are mainly driven by the addition of staff to
manage and support our clinical studies and development.

Thank you, and I'll turn it back over to Christopher.
Christopher U. Missling
President, CEO, Secretary & Director
Thank you, Sandra. Again, we look forward into 2022. We are very excited about the company's potential
as we build on the successful completion of 2 important studies that allow us to confidently expand further
into the rare disease space and plan expanded access for adult patients with Rett syndrome, while we are
looking forward to further pivotal clinical trial readouts in pediatric Rett syndrome and Alzheimer disease
and pipeline updates this year.
I would like now to turn the call back to Clint for Q&A.

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ANAVEX LIFE SCIENCES CORP. FQ1 2022 EARNINGS CALL | FEB 09, 2022

Question and Answer
Clint Tomlinson
VP of Corporate
[Operator Instructions] And our first question is coming from Charles Duncan with Cantor Fitzgerald.
Charles Cliff Duncan
Cantor Fitzgerald & Co., Research Division
Let's see. Can you hear me?
Clint Tomlinson
VP of Corporate
We can hear you.
Charles Cliff Duncan
Cantor Fitzgerald & Co., Research Division
Okay. Super. I had a couple of questions on the recent AVATAR readout, one on EXCELLENCE, and then I
wanted to ask Sandra a little bit about the cash runway.

So regarding AVATAR, we were quite intrigued with recent results. But I guess I'm wondering if you had
assessed just simply the change from baseline in RSBQ and CGI and if you intend to present that data
here in the near term. And then regarding the expanded access, is that part of an open-label extension
study or open-label extension to the AVATAR study?
Christopher U. Missling
President, CEO, Secretary & Director
Right. So get me -- first on the last question, the idea is expanded access is to provide not only for those
patients which have been participating in the trials to give the drug for free so they can continue to enjoy
the treatment effect, but also those patients which are not part of the trial. So that is the definition of the
expanded access. So that's what we are considering and working towards.

Regarding the first question, let me explain again the background of the response analysis. And the results
of the animal studies for Rett syndrome and other neurodegenerative diseases indicated that ANAVEX
2-73 has both symptomatic and disease-modifying effects on neurodevelopmental and neurodegenerative
diseases. And for that reason, the ANAVEX 2-73 analysis of the data should capture this kind of effect. And
this is done in the form of the way we have presented it as a response analysis with the RSBQ AUC.

Now on top of that, we have seen and we've learned in the paper, which was quoted and explicitly
mentioned also in the presentation of February 1, pointed out that RSBQ alone as a stand-alone has just
so many flaws that has, for example, 200 percentage upswing and downswing and is not calibrated in a
baseline. So it's just not fair to use it.

Whatever -- however, what we can say is that we make a reference of what is the CGI requirement of a
1 point scale improvement, which is a 3 or less, which is a minimum improvement of clinical significance.
And that represents a RSBQ change of average of 12.5 reduction of the RSBQ scale.

So knowing now that you have above average -- over 72% responder, which are better than 3 -- score
of 3, so they can have also a score of 2, which we have seen in this study. So you can see that the RSBQ
average needs to be at least more than 12.5 delta. So I hope that helps to explain this a little bit better.
Charles Cliff Duncan
Cantor Fitzgerald & Co., Research Division
It does, Christopher. I appreciate that, and definitely appreciate linking RSBQ to clinical benefit.

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ANAVEX LIFE SCIENCES CORP. FQ1 2022 EARNINGS CALL | FEB 09, 2022

Let me turn to EXCELLENCE. I guess I'm wondering if you'll use the same evaluation as was used in
AVATAR because I think clin trials has it a little bit different, and you might correct that.

And then the second thing about EXCELLENCE is that in terms of the patient enrollment to date, can you
give us some color on the number of patients enrolled? And when during the second half of '22 you would
anticipate that study to read out?
Christopher U. Missling
President, CEO, Secretary & Director
Yes. So the enrollment is going well. It's just that we learned that because of the COVID vaccines have
been approved around the world and also have been approved for children, which are younger than 18,
and the requirement is now that all these participants want to and need to and it's a fair proposition to get
vaccinated.

The protocol, however, requires that you have to be on a constant medication several weeks, I think it's
6 or 8 weeks in advance, before joining a trial. So that means that you have to get the first dose of the
vaccine but also the second one. And in time -- and then you have to allow for some time to pass by to
be on a stable new indication -- new medication, and vaccine is a new medication. So what it does, it
shifts a little bit out the time line to finish the last patients in this trial. The -- what was the other question,
Charles? I just...
Charles Cliff Duncan
Cantor Fitzgerald & Co., Research Division
Yes. I just -- I was just wondering if you can provide some color on the number of patients enrolled thus
far.
Christopher U. Missling
President, CEO, Secretary & Director
We are doing well from our perspective. I'd like to just mention that right now, we are very comfortable
with the time frame during second half '22 that gives us amply -- ample time to complete the study with
this additional required vaccination regimen. So this is sufficient for us at this point to share.
Charles Cliff Duncan
Cantor Fitzgerald & Co., Research Division
Okay. And you may narrow the time frame from, say, second half to a little bit more granularity in the
future as your enrollment progresses?
Christopher U. Missling
President, CEO, Secretary & Director
Exactly right. Yes. And in regards to the ClinicalTrials.gov, I would like to make, again, a statement here
that the ClinicalTrials.gov is not what we want to refer as to company communication. It will be updated
eventually. So I'd like to -- you to be aware of that. So the company communication is -- has priority over
ClinicalTrials.gov, but it will be updated when we have finalized the study outcome. And then we will also
update the ClinicalTrials.gov. Right now, it might not be completely up to date. So I want to make sure
people understand that.
Charles Cliff Duncan
Cantor Fitzgerald & Co., Research Division
Okay. Last quick question for Sandra. I think you mentioned $151 million go through '25. I assume that's
considering only the current spend and that you are not contemplating an NDA filing or commercial prep
for that runway and that the runway may change if you end up being involved in an NDA filing and/or
commercialization?
Christopher U. Missling
President, CEO, Secretary & Director
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Yes. If I can maybe start first. So we have over $150 million in cash, which is a really incredibly large sum
of money. And when you calculate our average cash utilization in the past was very consistent in the range
of $2 million per month to $2.5 million. And now in the last quarter, we averaged $2.3 million, I think.

So this exactly right will be the cash utilization. If we do have additional plans, which are marketing the
drug, of course, there will be a difference in that regard. So in this regard to the cash utilization is right
now continuing what we have planned, which is the several studies, which we mentioned we are planning
to do and executing the studies which are ongoing. So that is the assumption of the calculation.
Clint Tomlinson
VP of Corporate
The next question is coming from Soumit Roy at Jones Research.
Soumit Roy
JonesTrading Institutional Services, LLC, Research Division
Congrats on this quarter and the data. One question, Chris, I wanted to understand or get your take on,
how do you think FDA would look at 2 drugs being filed so close to each other with 2 different endpoints?
Curious if you would make any comment if you think they would ask Acadia to file it RSBQ AUC?
Christopher U. Missling
President, CEO, Secretary & Director
It's an excellent question. I would like to speak just on our data. We really think that, as I mentioned
before, every drug needs to be looked at in its uniqueness, and you want to analyze it with the drug effect
in mind. And that's what we've done.

And on top of it came the paper on the RSBQ, which really has extremely high variability and baseline
inconsistency. And again, I'm not speaking here out of line. It's really in this paper from 2020, which came
around the time when we finished our first study in the U.S. study. And that's what we learned from that
to adjust to this.

And then the guidelines of the FDA guidance are really specific, what to do in those cases. If you have a
baseline -- if you have an endpoint, which has not a totally reliability feature, then you can use what is
called the anchoring and use the response analysis.

But that requires -- it's very important, and we probably should highlight it stronger that this endpoint in
question needs to be correlating with the CGI. And if it doesn't correlate, you cannot use this anchoring
method. So -- and you are then left with a poor outcome.
But since we tested the correlation, and it should correlate because the difference between the 2
measures are the RSBQ is assessed by the parents, and the CGI are assessed by the physician. And while
they measure different things, they both should basically see a positive change independently of each
other. And so that means they should eventually correlate to a certain extent. And they do in our studies,
and they did in those studies, which is a good thing.

And so once you have established a correlation, then the FDA guidelines really explicitly say, please use
this anchor-based method because you just also take care of what the FDA is always concerned about not
clinically -- not statistical significance, but clinically meaningfulness. And by doing this, we basically raised
the bar for us, for the drug. But we also did it to make it easier to appreciate the drug effect because now
you can be assured that everybody who's a responder also has to have an improvement, which is clinically
meaningful.

So we made it for the FDA easier. That's why I think the guidance is very clear because they want to make
sure that you just don't have an average statistical improvement of a certain percentage and/or score,
but it doesn't mean anything to anybody. Nobody can confirm that it is beneficial. The physician cannot
assess it or confirm it. The patient cannot confirm it, and the parents cannot confirm it, but it's statistically
significant. So it doesn't help anybody.

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ANAVEX LIFE SCIENCES CORP. FQ1 2022 EARNINGS CALL | FEB 09, 2022

So by using this approach of the CGI anchored RSBQ, you'll see we were able to raise the bar, make it
easy to interpret. So it's the analogy of what we just also mentioned on the 1st of February of the story
of the way skin diseases are assessed in rash or other features that you have to raise -- reduce a certain
amount, a minimum amount. For example, in rash, it's at 75% or even 90% before being considered even
that the drug works. And this bar is what we have here included. And that allows for just more fair and
proper assessment of the drug -- of the effect of the drug.
Soumit Roy
JonesTrading Institutional Services, LLC, Research Division
Chris, that really helps. One last question is, if you can remind us if there is any formulation difference
between the adult Rett trial and the pediatric one? And if you could talk about if the liquid versus pills you
see any advantage you have versus your peers?
Christopher U. Missling
President, CEO, Secretary & Director
Yes. So we have for the Rett trials consistent liquid formulation across all trials, all 3 trials in the program.
So the U.S. study, the AVATAR and the EXCELLENCE, have exactly the same formulation. It's a liquid
formulation once daily orally, they take the amount of drug they need. And so there's no difference.

What maybe you are referring to is the formulation for the Parkinson's disease, dementia study and the
Alzheimer disease study. So in those cases, we have a once-daily solid capsule formulation or pill. And that
is obviously also at different doses, and that is taken in a solid form.

And the reason why we formulated or developed a formulation of liquid formulation of the drug was we
learned very early on that patients with Rett syndrome sometimes either cannot swallow capsules or pills
or they have not even the ability to take food or a liquid the normal way. They have a pouch, where they
have basically getting that injected. So you need to have a formulation which allows to do that, and a
liquid formulation is exactly suitable for that.
Clint Tomlinson
VP of Corporate
The next call is coming from Tom Bishop at BI Research.
Tom Bishop
BI Research
Can you hear me?
Christopher U. Missling
President, CEO, Secretary & Director
Yes.
Tom Bishop
BI Research
Okay. If memory serves me, on another call, you estimated that, I think, that the total Rett market could
be as much as $2 billion to $5 billion. And I was just wondering if my recollection is correct. And was that
for the U.S. or the world? And maybe even if you can tell us something about the adult Rett population
versus the pediatric.
Christopher U. Missling
President, CEO, Secretary & Director
Right. So the number, I don't think we mentioned it, but is back-on-the-envelope calculation, which I just
want to point out here. So on average, there are 11,000 patients assumed in the U.S., so let's simplify
10,000. And a rare disease pricing per year could be easily in the range, and I'm not saying that this is
the price of the drug for Rett patients, but it could be in the range of $200,000 to $500,000 per year per
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patient. And if you calculate and multiply this by 10,000, so the total revenue per year could be sales in
the range of $2 billion to $5 billion. I think that's probably the calculation was made. So that would be
addressing only U.S. market at this point.

If you also now look at specific to adult patients with Rett, we estimate this is around about 50% of the
patients in the -- of adult patients compared to the total patient amount. So you basically would assume
that the adult Rett population would be around about half of that.
Tom Bishop
BI Research
Okay. And then there's the whole world to boot.
Christopher U. Missling
President, CEO, Secretary & Director
And then there's whole world. We have -- obviously, the markets are large. What we have seen is that the
market sizes are in the range of, I would say -- what have we seen in -- an estimate Fragile X, Europe is
13,000, Asia is 37,000 and global 350,000.
Tom Bishop
BI Research
Was that Fragile X or Rett?
Christopher U. Missling
President, CEO, Secretary & Director
Yes, this is -- sorry, this is Rett syndrome only. So Rett syndrome, Europe is 11 -- 13,000. These are
all quoted references from the national foundations or respective information. And Asia's 37,000 Rett
syndrome patients and global 350,000 patients with Rett syndrome. Fragile X is larger. It's around about 6
to 7x the size of Rett syndrome.
Tom Bishop
BI Research
Okay. I note that the quarterly commentary, again, skips over Parkinson's disease dementia and the
physical aspect as well. And I'm wondering why that is. And what's the status?
Christopher U. Missling
President, CEO, Secretary & Director
No. We want to update when we have the updates. So the PDD study was really successful, and it
allowed us to move into now 2 directions. And we stated that. One is to plan a potentially pivotal study
in Parkinson's alone given the strong UPDRS signal as well as in UPDRS in Parkinson's disease dementia
given the strong cognitive improvement.

We are now discussing with the respective experts designs of such studies. And then we go with these
designs to the FDA, to the agency and ask for their input on how to execute those studies, and that's right
now taking place. So once we have feedback, we will come back and revert back on this.
Tom Bishop
BI Research
Good. Okay. And when do you estimate the last patient will complete the last observation in the 48-week
Alzheimer's trial? I understand that's fully enrolled at 509,000 -- 509 patients already, right?
Christopher U. Missling
President, CEO, Secretary & Director

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Yes, 509 patients. So we expect the last patient to be finished around probably summertime. And so I
think then we have to clean data and do data lock, and then we have the data. So that's right now the
expected time lines.
Tom Bishop
BI Research
Could you just describe the various steps of activities after the trial is over and the cleaning and eventually
then blinding the trial and crunching the numbers? I mean how long do these -- what are these various
steps? I think it would help everybody a little bit. And how long roughly -- a time range roughly do they
take?
Christopher U. Missling
President, CEO, Secretary & Director
Right. So the key bulk of the time is the data cleanup. So you have to be aware that a clinical trial once
it's data locked, what it's called, you cannot go in there anymore. You cannot even change a comma. It's
like locked as the word says.

So what you want to do, you want to double, triple, quadruple check every entry, that all the entries are
in there, that all items are explained, that there's no missing cell or whatever, like an Excel spreadsheet.
So this -- everything needs to be checked and double checked and triple checked. And that often takes
several months.

And once it's done, it's locked and then the time from lock to the unblinded data is very short. It's 2
weeks because then the CRO does that, and they do quality control themselves to double check that
the outcome is truly what they have -- the calculation is provided, and they double check with their own
internal control. And then they give it to us. So this is around about how it works.
Tom Bishop
BI Research
Okay. That's helpful. And there have been a lot of estimates of how big the revenue opportunity would be
for a drug that works on Alzheimer's disease, and I must confess to have made some myself in the U.S.
and the world. And for the U.S., I think it sounds to me like many think that could be around $10 billion
annually. But I'm more interested in what your thoughts are on that market potential size.
Christopher U. Missling
President, CEO, Secretary & Director
Yes. I mean, it's certainly not out of reach or unreasonable. I remember when the data or the approval
from Biogen was announced that the stock jumped to $30 billion. So if that is the expectation of net
present value of a successful trial -- potential successful drug can then go to market, then so be it.

And I think it's really like a measure of price times patients which are eligible. And then you have to make
the math from that point of view. But certainly, it's a largest unmet need. There's no doubt about that.
Tom Bishop
BI Research
I noticed that same $20 billion increase in the market cap of Biogen temporarily, anyway.
Christopher U. Missling
President, CEO, Secretary & Director
We have here another question if there is no other question. I was wondering if you could comment on a
couple of items. Will you consider initiating further trials in Angelman syndrome, perhaps a basket trial
with multiple gene-related disorders.

And so the answer to that question is we are planning already -- so let me ask this -- answer this. So
we want to basically bring home the Rett franchise first, and we're very close to that. And after that, we
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want to tackle these other indications, which we have preclinical data, information which is a conductive of
moving into a clinical trials, which includes Angelman syndrome.

But also, as I mentioned, I think, on the last call that we are planning to use a quasi-basket trial for
Fragile X because Fragile X is a very heterogeneous population. And we just wanted to make sure we're
addressing the right population for the cohort. And what we do, we do a quasi -- planning a quasi-basket
trial in Fragile X. So each cohort will be addressed and will be homogeneous. We are assessed by how well
they do with our drug. So we're already basically utilizing this basket-like trial designs to feature in our
next trial. Clint, are there any more questions do you see?
Xu Zou
Okay. Can you hear me?
Clint Tomlinson
VP of Corporate
Please go ahead, yes.
Xu Zou
Okay. This is Xu on for Yun. Congratulations on this quarter's progress. And I just want to take 1 step
back about the Rett syndrome clinical manifestation because Rett syndrome, that has pretty wide range of
clinical manifestation. So do you consider Rett syndrome primarily central nervous related or both central
and peripheral? Because a lot of multiple clinical trials have been using RSBQ and CGI as their primary
endpoint. But some experts believe RSBQ focus too much on behavior changes, but motor functions for
Rett syndrome patients are also important. So are you marrying any like motor function-related endpoints
in the trial?
Christopher U. Missling
President, CEO, Secretary & Director
Excellent question. And that's another reason why the RSBQ is basically not a bad endpoint, but just
needs to be put in the right perspective, and as a stand-alone, not sufficiently validated to represent the
full features of Rett pathology.

So the answer to that is twofold. Yes, we did see a signal also in movement features. We noticed that in
the quality-of-life assessment that there were some activities noticed in that regard, and the quality of life
also captures movement.
And also, for example, family cohesion. So is the family more happy to deal with things? And can the
patient do things by itself? And we also heard from some investigators that there were the ability of
moving the legs again which were not able to move before.

And to come to the question about the periphery versus central nervous system, I think this is a complex
disease. And as we learn more about it, we also have to appreciate that the fact that we have seen in
the periphery by measuring blood biomarkers of pathology like the GABA and the LAAA, which responded
nicely and were in line with the outcome of the patient benefit.

So these are also CNS-related features, but they were measured in the periphery. So we cannot exclude
that the periphery effect also is involved. But ultimately, we know that the key feature of the drug is really
on CNS. And we have seen that confirmed with the target engagement study we did prior with the PET
scan sigma-1 ligand.

So we definitely know that the key target point is in the brain. But again, I would not exclude that there is
also potential periphery effect, but the key target is definitely the CNS.
Xu Zou
It's helpful. So regarding your interaction with the regulators, have you already scheduled a meeting with
the FDA? Or when should we expect to see?
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Christopher U. Missling
President, CEO, Secretary & Director
Yes. So the way it works, we have to send to the FDA clinical trial reports, and they're required to be put
together. So it's not just the slides which we have. So in that right now is on the high pressure is taking
place. So once we have those slides, those documents done together, which are clinical study reports, the
formal report, then we will submit them and then request the meeting.
Xu Zou
Okay. So do you expect the feedback to be before the readout of EXCELLENCE study?
Christopher U. Missling
President, CEO, Secretary & Director
This is very likely because we said second half of 2022, so we expect that to be the case, yes.
Xu Zou
Okay. Sure. Second follow-up, your -- you just mentioned your basket study for 3-71 for 3 different
indications. Just can you give us more color on like 3 different indications, how do you plan to recruit the
patients and how to measure efficacy, this indication have very different endpoint or clinical duration like
[indiscernible] change very quickly. So do you have any prioritization or just give me color on that.
Christopher U. Missling
President, CEO, Secretary & Director
Right. So I think it was a bit of like maybe explained too quickly. We refer to Fragile X where we will
include Fragile X patients. These are all Fragile X patients, but they have different features which are
not identical. So they have to homogenize them to make them more consistent in their feature. We
group them in distinct groups of Fragile X. And it could be certain behavior prevalent -- certain cognitive
impairment prevalences and so forth. So that's what I was referring to do across the basket trial. So we
will measure the same endpoint, which is Fragile X-related endpoints.

When it comes to ANAVEX 3-71, which we are planning in Alzheimer in frontotemporal dementia and also
schizophrenia, this will be not basket trial. It will be in a program, call it. There will be trials which will be
done separately because schizophrenia, for example, requires a relatively short study duration, run about
6 weeks, for example. In the FTD and Alzheimer study require longer studies, at least 6 months. So you
see already from that angle that they are not -- that they cannot be put in one trial together.
Clint Tomlinson
VP of Corporate
That's all the questions, Dr. Missling.
Christopher U. Missling
President, CEO, Secretary & Director
So then we'd like to thank everybody. And again, as we look forward into 2022, we're very excited about
the company's potential as we build on a successful completion of the 2 important studies that allow us to
confidently expand further into the rare disease space and plan expanded access for adult patients with
Rett syndrome, and while we're looking forward to further pivotal clinical trial readout in pediatric Rett
syndrome and in Alzheimer's disease as well as pipeline updates this year. So with that, thank you very
much.
Clint Tomlinson
VP of Corporate
Thank you, ladies and gentlemen. And that concludes today's conference call. We appreciate you
participating. You can now disconnect.

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ANAVEX LIFE SCIENCES CORP. FQ1 2022 EARNINGS CALL | FEB 09, 2022

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