Full Year 2020 Anavex Life Sciences Corp Earnings Call

My name for NASA and I'll be your conference call. We are today welcome to the Index Life Sciences Corp, 2020 year end and fourth quarter Conference call. As a reminder, this conference call is being recorded I would now like to just your hosts for today's call for <unk>.

Thomas Please go ahead.

Thank you and good afternoon, everyone.

We appreciate you joining us today for Anavex Life Sciences conference call and webcast.

Our agenda is to review the company's financial results for its fiscal 2020 year.

And provide a clinical study update.

Taped replay of this call will be available approximately two hours after the call's conclusion and will remain available for one month.

The call will also be available for replay on Anavex as website at Www Dot Anavex dotcom.

With us today is dr. Christopher misleading.

President and Chief Executive Officer.

And standard Barnish principal financial Officer Doc.

Dr. Mr., <unk> and Ms. burnish will make prepared remarks, and then we'll take questions from equity analysts.

Before we get on began please note that during this conference call. The company will make some projections and forward looking statements regarding future events. We encourage you to review the Companys filings with the FCC.

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

These factors may include without limitation, the risks inherent in development and or commercialization of potential products on certainty and 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 cash.

On the call over to Dr. Miss one.

Thank you Glenn we appreciate everyone joining us today conference call to review our financial results and then the Glop day.

I would like to provide new key clinical update given the very encouraging data on the U.S. Rett syndrome study, we plan to advance the other car adult Rett syndrome study into a pivotal phase two stage preclinical trial.

In December 2020 on an ex announced topline results from a U.S. sales to control trial on the next 273 in adult female patients with Rett syndrome.

Brian we safety pharmacokinetics and secondary efficacy endpoints, where net.

With statistically significant and clinically meaningful consistent improvement index syndrome behavior question that ours, the Q and clinical global impression improvement.

Hi, Scott.

Improvement in our SBQ total scores were correlated with decreased improvement in plasma glutamate day.

Based on these results we are planning to meet with the FDA to discuss an accelerated approval pathway.

Current on we're planning a pipeline extension for 273, New thing gene Biomarkers of with volume and applying precision medicine for neurological disorders with unmet medical need this.

This includes a planned initiation of our pivotal phase two slash three study in price on ex syndrome. The most frequent genetic cause of autism spectrum disorder for.

For which we have convincing preclinical data.

We also are planning to initiate a phase twos next week clinical trial for the treatment of a new rare disease indication.

On the next 371, an orally administered small molecule targeting pick my one end and more on must covenant receptor that is not designed to be beneficial for newer the agenda that is currently in a phase one clinical trial and on track with topline data on anticipated in the first half of 2000.

Do you want.

Lastly, we plan to initiate a anavex 273 imaging for gross Parkinson disease clinical study in 2021.

Since our last conference call, we reported top line data of another clinical trial program Dave.

Data was presented in November at the detect 2020 contracts.

Reporting topline results from the proof of concept phase two placebo controlled trial with the primary objective of safety Tolerability and efficacy in cognition of on an exclusivity to free in patients with pockets for new dimension compared to placebo.

The primary objective of the study were met.

The results show clinically meaningful dose dependent and statistically significant improvement in the covenant of the truck research CDR computerized assessment system analysis.

A study confirmed the precision medicine approach of targeting pick the one that genetic buyer market in response to Anavex 273, and we are planning a pivotal trial of Anavex 273 in Parkinson's disease dementia. After submitting the results of the study to the FDA to obtain regulatory guidance.

Okay.

Lastly in November 2020 on an ex received a notice of allowance from the United States patent and trademark office USPI IPO for patent application number 16 last seven 1009 to one expected to maintenance for at least until 2037.

Expanding coverage of treatment methods using its deep drug candidate to setting the creep as well as drug candidate one for the one for treating a range of neurodevelopmental disorder, including wrecked syndrome out isn't spectrum disorder Angel non syndrome, cerebral palsy and multiple.

The roses among other indication.

While 2020 was marked by the outbreak of COVID-19, which has temporarily slowed down activities in many countries in which our 12, taking place our ongoing clinical trials were able to continue largely on it until uninterrupted in compliance with local regulation.

Okay and policy includes.

Including the enrollment of the phase two B.'s next week on a day to 73 Ultimate disease study, which currently reached over 80% enrollment will complete enrollment expected in early 2021.

And now I would like to direct the call to Sandra Burnish principal financial officer of Anavex for a brief financial summary of the recently reported quarter.

Thank you Christopher and good afternoon, everyone.

We reported continued fiscally responsible activities with a net loss of 26.3 million for 45 cents per share for the Twentytwenty fiscal year.

As compared to 26.3 million for 54 cents per share for the comparable 2019 fiscal year.

General and administrative expenses fell by approximately $1 million as a result from a reduction in non cash compensation charges.

Research and development expenses were 25.2 million for fiscal 2020.

An increase of 2.9 million over the comparable 2019 fiscal year.

This increase is the result of increased clinical trial activity and the continued advancement of our existing clinical trial.

We reported net increase in other income to 4.8 million for fiscal 2020 relating to research and development incentive income in connection with our Australian clinical trial activity.

Our cash position at September Thirtyth, 2020, with $29.2 million compared to $22.2 million at September Thirtyth 2019.

We are also reporting today, our cash position has increased to 47.6 million other today, which gives us sufficient cash for approximately the next 24 months.

Thank you and now I will turn the call back over to Christopher.

Thank you for some drop in summary, despite all of the new challenges to flow.

Thousand 20 was an extraordinary year for Anavex with significant progress across our portfolio.

We look for to building on this momentum with key milestones expected from multiple programs, including data from the ongoing late stage Rett syndrome trials other top and Exelon ex.

Spanning the clinical biomarker driven from 73 ready for this program into additional late stage studies with high unmet medical need.

Completing the late stage 273 phase to be Flexthree ultimate disease trial, and advancing two cents to three into clinical disease modifying testing parkinson disease at.

At this point I would like to thank the patient the doctor and entire Anavex team made all of this progress possible.

We look forward to providing for the updates as advancements continue.

I would now like to open the call for questions. Operator. Please go ahead.

At this time, we'll be conducting a question answer session for equity Alice I'd like to ask a question. Please press <unk> on the one on your top on key pump confirmation from indicate your line is now on the question queue. You May Press star one if youd like to move yourself on the Q.

Our first question comes from Charles Duncan from Cantor Fitzgerald.

Hi, yes, thanks for taking my questions happy holidays.

And Chris for all the great progress recently congratulations.

Had a couple of quick questions regarding the Ret program.

The ABA tire versus the recent adult study you mentioned that you are going to move forward with Avatar I said as a pivotal I'm I'm kind of wondering what has changed what will change in moving that forward.

And then when you consider it I guess characteristics of the cohort that was included in the sample in the recently read out adult study how is that different in any way with the Avatar study and then I have a follow up question.

Right.

So the other test study is designed is on pace to right now with the safety of the primary end point. So what we're doing we're switching the secondary endpoint, which is the efficacy measure of ours, PQ and CJ API to a primary endpoint. So thats a change which you can do in our ongoing studies without.

Moving on blinded.

And the difference the to the U.S. studied the other commodity is on average higher drug exposure profile for the doses are higher than the U.S. Doug study was so this why we also think we can capture and very important element, which the FDA looking for which is dose response.

Okay, and then when you think about the efficacy measures that were were made and and efficacy seen in the U.S. adult study how do you feel about.

Hi, Sam or sample size for the or the planned effects I started to hold for effect size out of avatar is there going to be a change in the sample size that you plan to enroll in that study.

Yes excellent question right now we don't have any.

Need to change that the number of patients in the other study, but it could well be that we will make an adjustment look to increase the size, but may be just to increase additional regions in that regard, but still it's not to complete the enrollment that might not require any changes.

Numbers.

But we.

We will not be left this discussion than the pilots gushing come out out of the discussion with the yes for.

For.

Before making a a change on that on debt level at this point.

Okay. So you do plan to meet.

With a half day, you're going perhaps to request a meeting here soon or or have you done. So and then and then the outcome of that meeting will possibly impact the design and conduct and sizing of avatar.

Right I mean, we have very good strong effect size of the U.S. study knowing that it would even on low dose we expect the hydros to even stronger and effect size. So right now we don't have an immediate need to change the design of the study other than switching the primary and secondary endpoints.

But what I want to point out is that ultimately we want to discuss with the FDA. Because we also want to make this as defined on pivotal study and if there are additional changes the FDIC and the agency Rick for Ben and we certainly will be open to debt.

Yeah that makes sense. It seems prudent last question on this is regarding the rat study that read out recently, but also the Parkinson's disease.

Initiating our dementia study that you alluded to when would you anticipate being able to present the data from those two studies in a peer reviewed for on it.

Yeah. So we want to be very transparent and we will you have to appreciate that the co primary endpoints for both studies in secondary efficacy endpoints will also looking at genetic outcome of the patient genetic background on the patients and that requires a bit more time than usually analysed.

So studies that is.

Well, we have to be the go through this before we can basically submit this to a publication, but we mentioned that we will submit to a publication the PD studies and not present, probably over the course of early 2021 more details about the PD study as well as direct study.

Okay last question, then I'll hop back in the queue regarding the pipeline and sorry for taken for this time, but right.

Regarding the pipeline you mentioned another rare disorder and on gifts Im wondering if you had mentioned it actually in the IP a discussion that you you.

You alluded to for example on Angel man or could could that be inclusive of Huntington type.

Right indication or an indication beyond say a nurse site rare disorder.

Excellent question.

We didnt want on not to mention that because we don't want to.

No prevent the knowledge, but it is just because the drug has shown no. In addition to infantile spasm an interim on syndrome. In addition, tourette syndrome, which we have in the clinical trial, but we have in total expense and the preclinical data as well as England presented already in the past in the meantime, we were able to cash.

Additional preclinical data of confirmation of efficacy in models of diseases, which are rare and developmental in nature.

Which are basically on top of those I. Just mentioned incidents are also non strategic discussion with regulatory as well as with clinical design, So which study would be quicker to perform versus other how is the competitive plant landscape looks like for these rare diseases. We just went on to that.

Homework to us before we engage into mentioning but it does but it will be one new indication, which I would not have yet we don't have yet mentioned in the slides presented so far.

More color in 2021, you suspect ex.

Exactly definitely want more colors coming 2021, and again, it's a rare disease, maybe even on ultra rare disease. So this is the really intriguing thing about it that we never stop binding or engaging in communities, which have an unmet need based on the approach of the drug to be upstream and regulates day.

Downstream features of Oklahoma spaces, and balance in the biological system and that benefits.

Quite a lot of additional indications and among them quite rare diseases and Thats why we want to basically not not.

Pass on on this opportunity for patients to help.

Got it thanks for taking all my questions happy holidays.

Likewise happy new year for to you on your team.

Our next question comes from.

Rob on the Blair from Ladenburg Thalmann.

Good afternoon and congratulations.

My question has to do.

Alzheimer's study.

Mention that you expect to complete enrollment for only in 2021.

And I was wondering when we might see the first on the data.

So the study is a 48 week study. So it's very simple to add one last patients have been enrolled than two at 48 weeks growth last patients enrolled in the study will also determine the last patient, finishing the study and Thats basically the simple on.

Suppliers majdic to do so that will be early 2000 2022.

Okay great.

And.

Also.

In addition to the cash balance as of September Thirtyth.

The 29.2 September Thirtyth.

[noise] day.

On.

Where that extra money came from.

Yes. So we have two program in place in order to basically be always able to.

I would say.

Strategically and also as least dilutive as possible when the stock price moves up to a higher level, we've utilized the ATM and the purchase agreement and one of those two features we were able to utilize to basically make sure. We always have two years of cash now that we have to use of cash.

Cash as of today Realty will not need to use it anymore going for it in a high frequency and that's basically the message we want to also send to our shareholders that we always want to make sure we have enough cash and resources. So we don't have any other.

The problem is executing on our activities.

Okay. Good.

For two here okay. Thank you very much.

Youre welcome.

Our next question comes from Tom Bishop.

From B. I research.

Yes, Hi, Christopher income.

[noise] Hello.

Yes, Hi can you hear me.

Yes, okay.

Okay.

I noticed this comment about the planned initiation of Anavex 273.

Imaging focused Parkinson's disease clinical study it didnt say dementia.

And I didn't understand the imaging focused on either could you put a little bit more on that.

Right. So we have been fortunate that we have been.

Receive funding a previously for Michael Fox for preclinical study in from.

In disease modification of Paul Parkinson disease, which is not part of the dementia just the movement disorder, and then we're being successful and not what the next step or we want to make sure that impact and from patients. So not dementia. We also understand better how the drug works and this is something we would like to explore this year.

[noise] for on the wireless phones, making this noise.

Okay.

Getting to the Australia trial.

I was for that.

Probably the company had to go to.

US sites I would have thought that there would be enough patients in Australia to to reach your goal of what is the 300.

Can you just explain a little bit more I mean, and what does that say about the market size on Australia.

The in the Australian are from a study you mean, yes.

So the Australian automotive these non international study. So we started in Australia and the face to be sourced we've actually now enrolling in.

Germany, Netherlands, UK and Canada.

In addition to Australia.

And so what we started on screen has been now expanded in three continents overall and so we just want to make sure that from International study has advantages and it was not that we were limited in Australia, but it's always an advantage to have sites running of this book.

Portion than in many different places.

Okay and also is there any thought being given to some interim analysis. So the Alzheimer's study that's not unusual.

For we got on Upto 15.

Total 2022.

The auction is they are because the protocol allows for an interim analysis explicitly mentioned that it can be used for interim analysis and we have seen debt interim analysis could be misleading as shown in the.

And on the company. So we don't know if we want to do that at this point in time, but the chances of them. So there is possibility that these data up before 2000 for into two for the other.

Okay.

The avatar and the and the adult Rett syndrome study moving on to phase two three.

I kind of thought that that was initially just a study so that you could.

Advance.

Into the adolescent.

Market, which I thought was your primary market, but are you going to pronged or you're going to you're going to test always on the adult.

So the adult.

The adult and all police catalyst.

Right sorry for interrupting so the adult population is that a.

Hey.

A population, which has book received much attention. Most two trials go for younger patients patriotic patients because the expectation is that the rain, it's more plastic and has a higher potential response than the.

Patients already advanced in age and therefore, the brain doesn't respond in more as much to a intervention we have seen a very strong response in eight of our older population Rett syndrome, which is very favorable to be interpreted because that makes us even more excited to see the data when we go to young.

Patients, but ultimately you want to capture the entire market right. So it's not limited to on age group, but its just often.

From the signal from stronger in the on the patients so, but we kept up we are aiming with the other time to excellence on the exact kept simple both both age groups at the adult above 18 years old and the age group.

In Europe.

Of 80 for the excellent study now enrolling.

Yes, it's enrolling very nicely.

That's the case.

Okay. Thank you.

Thank you.

Thank you there are no further questions at this time. This concludes today's call. Thank you ladies and gentlemen, you may now disconnect.