Q2 2022 Anavex Life Sciences Corp Earnings Call

<unk> Sciences fiscal 2022 second quarter Conference call. My name is Clint Tomlinson and I will be your host for today's call.

At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. During this session. If you would like to ask a question. Please use the Q&A box or raise your hand please.

Please note that this conference is being recorded call will be available for replay on <unk> website at www Dot <unk> Dot com.

With us today is Dr. Christopher <unk>, President and Chief Executive Officer, and Sandra <unk> 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 the current information and expectations.

And involve a number of risks and uncertainties.

We encourage you to review the Companys filings with the SEC.

This includes without limitation, the Companys forms 10-K, and 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in these forward looking statements.

These factors may include without limitation risks inherent in the development and commercialization of potential products uncertainty.

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. <unk>.

Thank you Glenn we appreciate everyone joining us today conference call to review, our most recently reported financial results and to provide a business update.

We are pleased with our continued advancement regarding our lead product candidate <unk> 273, and ultimate disease, and Tourette syndrome, as we maintain our attention on execution across each of our clinical programs and overall business operations in the second half of 2022, we expect.

Thing two pivotal topline results readouts, including top line results from the randomized placebo controlled phase II <unk> study on <unk> III <unk>.

Therefore for the treatment of ultimate disease and from the randomized placebo controlled excellent phase II <unk> III study on <unk> 273, Rs 330 for the treatment of patriotic patients with Ret syndrome <unk>.

Next month, we'll host an R&D day for investors and analysts on Tuesday June 21, 2022. This R&D day will include presentations from the company's leadership team with a focus on the company's clinical development pipeline additional details will follow closer to the event.

In July a oral presentation of effects of the Sigma one receptor agonist <unk> analytics to seven three.

A murine model of fragile X syndrome, neuro behavioral phenotypes and receptor occupancy will be presented at the 18th and FX X F International Fragile X Conference July 14 to 17022, taking place in San Diego, California.

Further pipeline expansion of the <unk> platform using gene Biomarkers of response applying precision medicine for neurological disorders with unmet medical need is expected in 2022, including meeting with the FDA to discuss the other exclusivity III Parkinson's disease program, including a pivotal phase III study.

<unk>.

Planned initiation of a <unk> III imaging focused parkinson disease clinical study sponsored by the Michael J Fox Foundation.

And a planned initiation of a potentially pivotal phase II III study in fragile X. The most frequent genetic cause of autism spectrum disorder.

And our planned initiation of our phase III <unk> III clinical trial for the treatment of a new rare disease indication.

<unk> planned initiation of <unk> hundred 71 phase II clinical trial for Frontotemporal dementia sheets, Affinia and ultimate disease indications.

Now I would like to direct the call to Sandra Burnish principal financial officer of <unk> for a brief financial summary of the recently reported quarter.

Thank you Christopher and good afternoon, everyone.

During the quarter ended March 31st 2022, we continue to maintain fiscally responsible cash utilization as we expand and advance our pipeline.

Our cash position at March 31st 2022 was $153 3 million, which.

Which we believe is sufficient cash runway to fund our operations and our clinical programs beyond the next four years.

Our research and development expenses for the first quarter to the second quarter of fiscal 2020 to $8 6 million.

As compared to $6 7 million for the same quarter of fiscal 2021.

General and administrative expenses were $2 9 million compared to $2 $2 million in the comparable quarter of 2021.

Overall, we reported a net loss of $10 4 million for the quarter, which is <unk> 14 per share.

The overall increase compared to the previous year period is primarily related to an increase in noncash compensation chartering period over period.

Which is driven by the addition of staff to manage and support our clinical studies and development.

Thank you and now I'll turn the call back over to Jim Hi, Christopher.

Christopher.

Sandra So we're looking forward to the next month's R&D day events, where we will present, our broad Sigma one our platform portfolio, which allows us to expand further within the neuro degenerative and rare disease space and we remain on track to deliver data readouts as we are present as well as presentations at medical meetings.

<unk> and initiating biomarker driven precision medicine clinical studies.

Throughout the rest of the year as planned.

I'd like now to turn the call back to plan for Q&A.

Yeah.

Thank you.

Christopher will now begin the question and answer session. If you have a question. Please raise your hand or enter it into the Q&A box.

Our first call is coming from <unk> at <unk>.

Okay.

Go ahead, Ian Hi.

Yes. Thank you very much for taking my question so.

Absolutely.

Pediatric Tourette syndrome study and I see that the study has not completed patient enrollment. So I assume it's still ongoing so I wanted to confirm if youre going to put out the press release on patient enrollment completion and on the primary endpoint is.

Is it reasonable to assume that it's still going to be.

And have you talked to the FDA.

Yes.

I believe the last guidance or last.

Yes business guidance after the.

Second.

Data readout from the Red syndrome was that you were going to talk to the FDA. So has that happened yet.

Thank you for the call. Indeed, so the last communication is that we are planning to meet the FDA to discuss the ret program and his procedure to move forward with filing an NDA for approval.

And since we finished and completed the Avatar study in adults a small study. Despite the fact that it's a successful study a phase II study, which was also small and the ongoing excellent study, which isn't patriotic study, which is the largest study. So we are waiting for this meeting to take place. It has much of taking place, but it will take place.

Soon and then we will learn how to move forward and indeed, the ret such excellent study with patriotic patients is still ongoing and enrolling and we might have.

A press release when the enrollment is completed.

So the.

With regards to the primary endpoint is still going to be RSP and you see instead RFP queue next slide so when we presented our <unk> study we learned from the first phase II study that the RSV acute AUC that includes the.

CGI I link.

Responder analysis, so the RSP deal Youll see includes the CGI I respond analysis linked responder analysis that is the endpoint, which we will also propose for the excellent study that is correct. It's consistent with the Avatar study.

Okay. So the second question is on the Parkinson's disease program and can you remind us what you would like to achieve with.

Imaging study and do you need to talk to the FDA before you initiate the imaging study.

It's a good question. So the goal is to show what we have already seen with the.

Frequently that the Sigma one is completely clearly dose dependent target engaging the sigma one receptor in the brain and that is additional confirmation in humans and among them also in Parkinson patients. That's why we were able to receive their full support.

Non dilutive funding of the brand from the microphone explanation for this study and we probably will very likely.

Use that opportunity to meet also with the FDA to discuss the Parkinson's program in its totality, including the phase III, which we said we were happy to move forward with given the successful phase III PDP study.

Okay, great. Thank you very much and we look forward to the R&D day in June .

You very much.

Thank you the next call is from Pete.

<unk> from Cantor.

Go ahead Pete.

Pete I think you are muted.

Hi, Chris how are you good how are you.

So I don't know if I missed it in the previous question, but I know that you haven't spoken to the agency recently, but from previous discussions or do you have a sense of whether or not.

I need to wait for the pediatric data to file for the adult indication.

So the periodic data as a larger study and in theory. If you would file for adults you would not need it because it's a different age groups, but what we believe is probably a prudent assumption is to include the patriotic study in its totality for the Ret program, but as we can.

Stated, we don't know that yet until we meet the FDA for guidance on how to move forward in terms of regulatory filing for approval of <unk> for Ret syndrome.

Alright. Thanks.

For clarification.

I also wanted to ask about your thoughts regarding sort of the lessons the takeaways from the ret syndrome experience with about $2 73, and <unk> 82 to potentially.

Clinical development initiatives.

With the compounds in fragile X and if you could give us a sense of when you anticipate the fragile X program to initiate patient enrollment.

Right. So we are very excited about the fragile X program for two reasons first of all we have very solid and it is a very.

Strong evidence in animal model in fragile X, which was published last year and as a <unk>.

New data coming out and among them. It will be presented also at the conference in July , which we pointed out and there will be additional biomarker information and making very clear of pathology biomarker pathology. They can clear that the drug really improves the phenotype of this disease, which is the largest.

Autism spectrum disorder, and why it's exciting for a second reasons causes largest autism spectrum disorder is like ret syndrome.

<unk> under the autism spectrum disorder, and we measured the <unk> score, which is a key measure of anxiety, which is a known feature of.

Limitation problem for these patients with autism and we were very successful in that boat.

<unk> studies in the phase II and the phase III Avatar two successful improvement with the drug on this endpoint of the atom score.

That is why we are excited both from the preclinical data as well as from the clinical data side of point of view. So what we're now doing we want to make sure. This protocol is very robust because the challenge of fragile X.

A very diverse patient profile. So they are very different.

Different features of the disease, which is not similar and we want to make sure. We are using a population of dry population, which is homogeneous as possible. So in order to avoid it.

Trial failure, because the drug doesn't work, but because the patients are so different and the endpoints you selected for these patients don't apply to all and it is a key what we are now in the process of figuring out then we will meet with the agency and confirm that approach and also make sure that we can run.

This is a pivotal study so we expect this to take place in the second half of this year.

Okay and the same at.

At the same time will you be also consulting with the EMA or.

That will be at a later time point that's right. Since we will include most likely also patriotic patients. We will also include to discuss with EMA, which is important because they want to be also have a discussion before that trial starts.

Okay.

And just one last question on the Alzheimer's program or can you provide any type of color on the or the rollover rate you know offer from the phase two b three into the open label extension, yes. So the last I heard was there was over 90% rollover foundations are finished two placebo controlled study in the open label extension. So that's very.

Positive sign.

And we're very excited because were getting really close to finishing the study of the last patient out and then we can start the process of data cleanup as well as then the locking the database and then subsequent releasing the data and we're very excited about this.

Excellent. Thank you very much for taking our questions. Thank you Pete.

Okay.

The next question is.

Guessing from Sumit Roy it.

Jones research.

<unk>, Okay, great sorry.

Congrats on all the progress.

A question on the Alzheimer's front could you give us a little.

Final detail on when should we think the data to come out is it.

Is it third quarter or fourth quarter and.

It's a good question. So since we said second half I'd like to stick to that because we don't know exactly how long the data feed upticks and if it takes it's.

It's quicker done performed.

B and the.

Q3, and if it takes longer than it will be.

Slipping into Q4, so it's best really to call. It Q second half 2022.

When we have.

More clarity, we will provide a closer update.

Yeah.

Okay.

Okay.

Was that the only question.

Okay.

Thank you for taking the question.

Great. Thank you I have one question from months Selim from HC Wainwright.

And he said what are the key points of the agenda for your upcoming meeting with FDA.

With the Parkinson's disease program pivotal study for example, with a biomarker endpoint be pushed up in priority.

Owing to your recent success with Sigma one MLR mrna expression data in phase II.

This will be all on the agenda and since we are sharing this data.

Very timely now and.

We want to also make sure we are able to include the extension data of the Parkinson's study.

Since this is now completed and once we have that we will be able to have a big bigger bigger picture of the Parkinson program and the items you just referred to will be all discussed.

Okay.

Okay.

Question from Us.

Can you give us a preview of the new indication that you're excited about in the near degenerative and rare disease space.

But youll be showcasing at your upcoming R&D day event right. So we will have the ability to choose between several readiness indications and that's why we have kept like that and it really shows the worth and the value of the platform, we have and it's backed by quickly.

Data on different indications and so we want to make sure we are doing.

During the pariah tithing the rights rare disease.

If we are comfortable with the clinical design to show efficacy and that's really what we're working on so we that's why we didn't mention what indication of this but the different indications separate communications independent indications, which could become.

Indication, which we will release once the trial starts and it's only because we have the ability to showcase several rare disease indications being demonstrated positive the impacted by the drug out of equities and <unk> III in respective clinical animal models.

Ah moves I see are in the in the chat now you can go ahead and ask your own questions.

Hi.

Great. Thanks, Yeah, I'll save you some trouble.

Hi, Chris Thanks for taking my questions.

In terms of your upcoming 273 image focused Parkinson's study.

We were wondering if you collected imaging data from the phase III trial, and if you did could this methodology from your current study be used to combine the data.

If I might ask combining data with what exactly.

From.

If you may have collected imaging data in the phase III trial or you did not collect any imaging.

We did not in the phase II pockets in the dimension study, yes. There were no imaging study collected Metallurgist imaging study separately is now taking care of that.

Okay understood and in terms of 371%.

Will you use the same cohort characteristics.

Or do you think this drug could potentially differentiate from 273.

And be more efficacious in certain sub populations of patients.

Patients. That's an excellent question. So we are expecting that there will be some additional data on 371, particularly also to give us guidance on this.

Fine tuned.

The indication, but right now without any further.

<unk> knowledge on this.

It could be the best choice for going into patients with AMD.

Which are have the best.

I would say cohort consistency and.

And <unk> two and also the ability to make the trial as you know.

Robust and as quick as possible and its enrollment. So this will be more likely the early alzheimers disease patients similar to what the phase III of the annex II <unk> III study is right now.

Okay understood and just finally on 371, we're looking forward to this one.

Could you expound briefly on the strategy for three indications for this program. So clearly FTB appears to be a front runner in here how confident are you.

In the schizophrenia indication given the Sigma one receptor activation, that's been associated with off target effects and psychosis yet.

So we achieve very excited because 371 as a reminder to everyone is not only a sigma one agonist, but also an <unk> agonist.

There are trials up now which has been shown a very successful in this indication of fleets aphemia with pure <unk> agonists and if you now look at what we heard from the inventor of unabated through 71, who always told us that he looked at <unk>, one agonist as a target any.

Found that by accident so to speak.

71, <unk> more potent than all the other previous proxy has developed an <unk> agonist and we looked at the profile of this 371 molecule you saw that there was not only in one agonism, but also a sigma one activity. So he populates it.

371 inches of Premier is more.

Proactive and successful, possibly because of the <unk> activity.

And so that's why we're excited about the 371, if safina as well.

Okay brilliant thanks for taking my questions. Good luck. This year. Thank you very much.

Okay.

Okay.

Okay.

Okay.

It looked like maybe you had a follow up question or.

Yes, yes. Thank you very much particularly follow up question. So it looks like you have a lot of them.

Milestones planned for the second half of this year and so.

Wonder.

No question in the capacity to be able to complete all the milestones.

Lot of activity, but if you'd have to talk about the priority, which one do you think could be the most important one.

That should take for the pipeline to about one.

I think it's really consistent with the bullet points you have seen today. So it's really finishing the optima study, which is an auto pilot. So we just have to do.

The cleanup work if you select and the same is finished the ret study, but then following with a priority I think it would go into fragile X study given that it's a relatively short study.

And can be pivotal potentially and it's a huge unmet need in <unk>.

Seven times the size of Ret syndrome in terms of Ah indication number of patients. But then also following up with the Parkinson disease pivotal study and also I would not rule out Frontotemporal dementia, and also should saphena, especially shipped to <unk> four 371, when I say frontotemporal dementia.

Four 371, because <unk> is relatively short study and that obviously would be important to that but also I don't want to forget to mention the rare disease, which we have not yet given the name for the indication and to do a pivotal study in that indication so really consistent with the bullet points, we have seen.

Okay, great. Thank you for the confirmation.

Thank you.

Yeah.

Yeah.

It looks like we may have a follow up question from Pete as well.

Maybe not.

So Christian I think that that.

Debt.

I have no further questions at this time, so you can continue.

Very much so again to reiterate.

We are looking forward into the remainder of 2022, and we're very excited about the company's potential platform, especially as we build on successful completion of three important biomarker driven precision medicine.

Pivotal studies and we're looking forward to the pivotal clinical readouts in ultimate disease, and patriotic syndrome, but also we are very excited to move forward with the planned studies, which we really want to initiate because of its unmet need and we're very excited about this so look forward to updates and reach out to us for <unk>.

Questions.

Ladies and gentlemen that concludes the call today. Thank you for participating and you may now disconnect.

Thank you.

Yeah.

Yes.

Okay.