Anavex Life Sciences (AVXL) Q1 2022 Earnings Call Transcript

Anavex Life Sciences (AVXL 1.48%)
Q1 2022 Earnings Call
Feb 09, 2022, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

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, 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 an 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 Missling -- President and Chief Executive Officer

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 topline results of the randomized placebo-controlled AVATAR phase three study. For the treatment of adult patients with Rett syndrome and the positive topline results from the placebo-controlled phase one study of ANAVEX 3-71, which is in development for the treatment of neurodegenerative diseases, including FTD frontotemporal dementia, and the 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 phase, including implementing expanded access for adult patients with Rett syndrome, and 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 topline results from the second randomized placebo-controlled AVATAR phase three study for the treatment of adult patients with Rett syndrome. The study met its primary and secondary efficacy, and safety end points with consistent and clinically meaningful improvements in all efficacy measures of Rett syndrome symptoms. Convenient once daily oral liquid doses of up to 30 mg of ANAVEX 2-73 were also well-tolerated with good medication compliance. Based on the results of the AVATAR phase three study, and the prior successful U.S.

phase two study in adult patients with Rett syndrome, Anavex is now planning to meet with the FDA to discuss the approval pathway. Topline results from the placebo-controlled EXCELLENCE phase 2/3 study for the treatment of pediatric patients with Rett syndrome are expected in the second half of 2022. The extension of the expected duration of enrollment is based on recent country and local government requirements for children who have full COVID-19 vaccination prior to joining a clinical trial, which includes our pediatric EXCELLENCE trial. This phase 2/3 study in pediatric patients with Rett syndrome aged five to 18 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 2/3 ANAVEX 2-73-AD-004 study for the treatment of Alzheimer's disease are also expected in the second half of 2022. The 509 patients late-stage phase 2b/3 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 two different once-daily oral 2-73 doses or a placebo. The current data allows us to expand in parallel ANAVEX platform pipeline using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need, which are expected in 2022, that includes; the planned initiation of 2-73 imaging-focused Parkinson's disease clinical study; a planned initiation of a potentially pivotal phase 2/3 study in Fragile X syndrome, the most frequent genetic cause of autism spectrum disorder; and a planned initiation of a phase 2/3 dental trial for the treatment of a new rare disease indication as well.

Last month, Anavex reported positive topline results from the placebo-controlled phase one 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 courts, receiving ANAVEX 3-71 in single doses ranging from 5 mg to 200 mg daily with no serious adverse events and no significant lead abnormalities in any subject. Based on these results in ANAVEX 3-71 preclinical profile, we intend to advance 3-71 into a biomarker driven clinical development dementia program for the treatment of FTD frontotemporal dementia, schizophrenia and Alzheimer 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 and 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 non-cash compensation charges of $3.9 million, compared to net loss of $7.9 million, or $0.12 per share, inclusive of non-cash 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 non-cash compensation charges of $1.7 million for research and development and $1.3 million for general and administrative expenses period-over-period. These increases in non-cash 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 Missling -- President and Chief Executive Officer

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 two important studies that allow us to confidently expand further into the rare disease phase, and plan expanded access for adult patients with Rett syndrome. While we're looking forward to further pivotal clinical trial readouts in pediatric Rett syndrome and Alzheimer's disease, and pipeline updates this year.

I would like now to turn the call back to Clint for Q&A. 

Questions & Answers:

Operator

Thank you. We will now begin the question-and-answer session. [Operator instructions] And our first question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead, Charles.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Let's see. Can you hear me?

Operator

We can hear you.

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. Super. Thanks, Clint. Hi, Christopher and team.

Thanks for hosting the call. 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 Missling -- President and Chief Executive Officer

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 were considering and working toward. Regarding the first question, let me explain again the background of the respond 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 degenerative 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 respond analysis with the RSBQ you see.

Now on top of that, we have seen and we've learned in the paper, which was accorded and explicitly mentioned also in the presentation of February 1st, pointed out that the RSBQ alone is a stand-alone, has just so many flaws that has, for example, 200 percentage upswing and in downswings and is not calibrated in the 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 one point scale improvement, which is a three 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 score of three, so they can have also a score of two, which we have seen in this study. So you can see that 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 Duncan -- Cantor Fitzgerald -- Analyst

It does, Christopher. I appreciate that. Definitely appreciate linking RSBQ to clinical benefit. Let me turn to excellence.

I guess I'm wondering if you'll use this same evaluation as was used in AVATAR because I think clin trials has had 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 readout? 

Christopher Missling -- President and Chief Executive Officer

Yeah. 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 six or eight 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 on a new medication and the vaccine is a new medication. So what it does, it shifts a little bit about the timeline to finish the last patients in this trial. What was the other question, Charles? I just --

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yeah. Was just wondering if you can provide some color on the number of patients enrolled thus far? 

Christopher Missling -- President and Chief Executive Officer

We are doing well from our perspective. I like to just mention that right now, we're very comfortable with the timeframe to being second half '22. That gives us ample time to complete the study with this additional required vaccination regimen. So, this is sufficient for us at this point to share. 

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. And you may narrow the time frame from, say, second half to a little bit more granularity in the future as your enrollment progression?

Christopher Missling -- President and Chief Executive Officer

Exactly right. Yes. 

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. 

Christopher Missling -- President and Chief Executive Officer

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 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's might not be completely up-to-date, so I want to make sure people understand that. 

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. last quick question for Sandra. I think you mentioned $151 million could 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 in being involved in an NDA filing and or commercialization. 

Christopher Missling -- President and Chief Executive Officer

Yeah. 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 casualization 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 casualization is right now, continuing what we have planned, which is the several studies which we mentioned we are planning to do in executing the studies, which are ongoing.

So that is the assumption of the calculation. 

Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. Thank you. 

Christopher Missling -- President and Chief Executive Officer

Thank you.

Operator

Yeah. The next question is coming from Soumit Roy at Jones Research.

Soumit Roy -- JonesResearch -- Analyst

Hi, everyone. Thank you for taking the question, and congrats on this quarter, and the data. One question, Chris. I want to understand or get your take on how do you think FDA would look at two drugs been filed so close to each other with two different endpoints? Curious if you would make any comment if you think they would ask [Inaudible] to file it with RSBQ [Inaudible]

Christopher Missling -- President and Chief Executive Officer

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 visibility 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 liability a feature, then you can use what it's called the anchoring and you the respond analysis. But that requires it's very important, and we probably should highlight the stronger, that this endpoint in question need to be correlating with the CGI. And, if it doesn't correlate, you can use this anchoring method, so you are then left with a poor outcome.

But since we tested the correlation, and it shouldn't correlate because the difference between the two measures are RSBQ as assessed by the parents, and the CGI-I as 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 both studies, which is a good thing. And so once you have established the correlation, then the FDA guidance really explicitly say, "please use this and go-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 is 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 and statistically 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.

So by using this approach of the CGI anchored RSBQ, you 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 as other features that you have to raise reduce a certain amount, a minimum amount, for example, in rashes that 25% or even 90% before being considered even that the drug works. In this bar is what we have here included, and that allows for just more fair and proper assessment of the effect of the drug.

Soumit Roy -- JonesResearch -- Analyst

Thank you, Chris. That really helps. Thank you for getting into the details. 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 Missling -- President and Chief Executive Officer

So we have for the Rett trials, consistent a liquid formulation across all trials, all three 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 is no difference. What maybe you're referring to is the formulation for the Parkinson's disease, Dementia study, and the Alzheimer disease.

So in those cases, we have a once-daily solid capsule formulation or pill, and that is of the different doses, and that is taken in a solid form. And the reason why we formulate it 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 or capsules or pills, or they have not even the ability to take food or liquid the normal way. They have a pouch where they have a basically getting that injected, so you need to have a formulation which allows to do that in a liquid formulation is exactly suitable for that.

Soumit Roy -- JonesResearch -- Analyst

Thank you, Chris. Really appreciate and congratulations again on the robust data.

Christopher Missling -- President and Chief Executive Officer

Thank you. 

Operator

The next call is coming from Tom Bishop at BI Research. Go ahead, Tom.

Tom Bishop -- BI Research -- Analyst

Hi, can you hear me?

Operator

Yes.

Tom Bishop -- BI Research -- Analyst

OK. If [Inaudible] 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 there for the U.S., for the world? And maybe even if you can tell us something about the adult population versus the pediatrics?

Christopher Missling -- President and Chief Executive Officer

Right. So the number, I don't think we mentioned, but is a 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 patient.

And if you calculate and multiply this by 10,000, so the total revenue per year could be sealed in the range of $2 billion to $5 billion. I think that's probably the calculation was made. So that would be addressing only the U.S. market at this point.

If you also now look at specific to adult patients with Rett, we estimate this is run about 50% of adult patients compared to the total patient amount. So you basically would assume that the adult Rett population would be run about half of that.

Tom Bishop -- BI Research -- Analyst

OK. And then there's the whole world to boot, huh? 

Christopher Missling -- President and Chief Executive Officer

And then this whole world we have obviously, the markets are large sample of what we have seen is that the market sizes are in the range of, then we've seen and estimates Fragile X, Europe is 13,000, Asia is 37,000, in global 350,000.

Tom Bishop -- BI Research -- Analyst

Was that Fragile X or Rett?

Christopher Missling -- President and Chief Executive Officer

Yeah, this is a I'm sorry, this is Rett syndrome only. So Rett syndrome, Europe is 13,000. These are all coded references from the national foundations or respective information in Asia to the 7,000 Rett syndrome patients, and global 250,000 patients with Rett syndrome. Fragile X is larger, it's about 6 to 7 times the size of Rett syndrome.

Tom Bishop -- BI Research -- Analyst

OK. I note that the quarterly commentary against 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 Missling -- President and Chief Executive Officer

No, we want to update when we have the updates. So, the PDD study was really successful and that allowed us to move into now two directions. It was stated that, one is to plan a potentially pivotal study in Parkinson alone, given the strong UPDRS signal as well as in UPDRS in Parkinson and Dementia, given that 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 asked for their input on how to execute those studies.

And that's right now taking place. So once we have feedback, we will turn back and revert back on this. 

Tom Bishop -- BI Research -- Analyst

Good. OK. 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 patients already, right? 

Christopher Missling -- President and Chief Executive Officer

Yup. 509 patients, so we expect the last patient to be finished around about probably summertime. And so I think then we have to clean data into the airlock, and then we have the data. So that right now the expected timelines.

Tom Bishop -- BI Research -- Analyst

Could you just describe the various steps of activities after the trial is over? The cleaning, and eventually the unblinding the trial, and the crunching the numbers? How long do these very, what are these various steps? I think it would help everybody a little bit, and at how long roughly a time range roughly do they take? 

Christopher Missling -- President and Chief Executive Officer

All right. So the key bulk of the time is the data cleanup. So you have to be aware that a clinical trial wants its data locked, what's 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 a double, triple, quadruple check every entry. That's 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 there's everything needs to be checked and double check, and triple check, 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 two weeks [Inaudible] the zero 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 run about how it works.

Tom Bishop -- BI Research -- Analyst

OK. 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 in 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 Missling -- President and Chief Executive Officer

It's certainly not overreach 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 our net present value of a successful trial, or successful potential, successful drug that go to market, then so be it. And I think it's really like a measure of price times patient which are eligible, and then you have to make the math from that point of view, but certainly it's a large unmet need. There's no doubt about that. 

Tom Bishop -- BI Research -- Analyst

I noticed that same $20 billion increase in the market cap of Biogen temporarily anyway. OK. That's it for me. Thank you, thanks for --

Christopher Missling -- President and Chief Executive Officer

Thank you. We have here another question. If there's no other question, I was wondering if you could comment on a couple of items, will you consider initiating further drugs 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 you this [Inaudible] this.

So we want to basically bring home the Rett franchise first, and we're very close to that. And after that, we want to tackle these other indications, which we have preclinical data information which is, a conductive of moving into a clinical trial, which includes Angelman syndrome. But also, as I mentioned, I think on the last call that we're planning to use a quasi basket trial for Fragile X because Fragile X is a very heterogeneous population, and we just want to make sure we are addressing the right population for the court and what we do a quasi planning a quasi basket trial in fragile X, so each cohort will be addressed, and will be homogeneous the assessed by how well they do with our drug. So we are basically utilizing this basket like trial designs to feature in our next trial.

Are there any more questions, [Inaudible]? 

Unknown speaker

OK. Can you hear me?

Operator

Oh, please go ahead. Yes. 

Unknown speaker

Oh. OK. thank you for taking our question. [Inaudible] Congratulations on the quarter as progress.

And I just want to take a one step back about [Inaudible] manifestation because [Inaudible] clinical manifestation. So do you consider resident primary, central nervous related or both central and peripheral because of multiple clinical trials have been using RSBQ as their primary endpoint. But some experts, we believe, RSBQ focused too much behavior changes by motor functions for Rett syndrome patients are also important. So are you [Inaudible] any motor function related endpoints in the trial?

Christopher Missling -- President and Chief Executive Officer

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 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 notice in that regard in the quality of life also captures movement.

And also, for example, a family cohesion. So is the family in 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 we're 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 a pathology like the GABA and the L Triple A, which responded nicely and we're in line with the outcome of the patients 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 the same order on the CNS. And we have seen that confirmed with the target engagement study we did prior with a Pet scan sigma one ligand. So, we definitely know that the key target point is in the brain. But again, I would not exclude that there's also potential periphery effects.

But the key target is definitely this CNS

Unknown speaker

Thank you, it's helpful. So regarding your interaction with the regulators, have you have you already scheduled a meeting with FDA and when do you expect the feedback?

Christopher Missling -- President and Chief Executive Officer

Yep. So the way it works, we have to send to the FDA clinical trial reports, and they require to be put together. So it's not just the slides which we have. So in that right now on the high pressurize taking place.

So once we have those slides, those documents down done together to do a clinical study reports, the formal reports. Then we will submit them and then request the meeting.

Unknown speaker

OK. So do you expect this feedback to be before the readout of the EXCELLENCE study?

Christopher Missling -- President and Chief Executive Officer

This is very likely because we said second half of 2022, so we expect this to be the case. Yes. 

Unknown speaker

OK. Sure. Thank you. Also going to follow up, you just mentioned to a basket study for 371 [Inaudible] indications.

Just can give us more colors on that? So different indications, how you plan to treat patients and how to measure efficacy this indication have different endpoints or clinical duration? Like Schizophrenia can still change fairly quickly. So you have any prioritization or just getting the color on that.

Christopher Missling -- President and Chief Executive Officer

Right. So I think it was a bit of like a 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 homogenized them to make them more consistent in their future.

We grouped them in distinct groups of Fragile X. and it could be a certain behavior prevalent, certain cognitive impairment, prevalences and so forth. So that's what I was referring to a quasi basket, right? So we will measure the same endpoints, which is Fragile X related endpoints. When it comes ANAVEX 3-71, which we are planning in all summer.

In Frontotemporal Dementia and also Schizophrenia, this will be not basket trial. it will be in a program we call it. There will be trials which are done separately because of Schizophrenia, for example, requires a relatively short study duration run about six weeks, for example, in the FTD and Alzheimer's study required longer studies at least six months. So you see already from that angle that they are not that cannot be put in one trial together. 

Unknown speaker

OK. Thank you. That's helpful.

Operator

That's all the questions, Dr. Missling. 

Christopher Missling -- President and Chief Executive Officer

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 the successful completion of the two important studies that allow us to confidently expand further into the Rett disease phase and plan expanded access for adult patients with Rett syndrome. And, while we're looking forward to further pivotal clinical trial readouts in pediatric Rett syndrome and an Alzheimer's disease and as well as pipeline updates this year. So with that, thank you very much.

Operator

[Operator signoff]

Duration: 40 minutes

Call participants:

Christopher Missling -- President and Chief Executive Officer

Sandra Boenisch -- Principal Financial Officer and Treasurer

Charles Duncan -- Cantor Fitzgerald -- Analyst

Soumit Roy -- JonesResearch -- Analyst

Tom Bishop -- BI Research -- Analyst

Unknown speaker

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