Q3 2020 Anavex Life Sciences Corp Earnings Call
[music].
Welcome to the NFX life Sciences.
Now, let's call it 2023rd quarter financial results Conference call. My name is your bike and I'll be your operator for today's call. At this time all participants are in listen only mode.
Please note that this conference is being recorded I will now turn the call over a quick Howe Robinson. Please go ahead.
Thank you and good morning, everyone.
We appreciate you joining us today for Anavex Life Sciences conference call in web cast.
Our agenda is to review the Companys financial results for its third quarter of fiscal 2020.
And provide a clinical study update.
[laughter] 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 kind of X's website at www Dot Anavex dotcom.
With us today Dr. Christopher misleading.
President and Chief Executive Officer.
And Sondra Burnish principal financial officer.
Dr misleading and Miss Burnish, well make prepared remarks, and then we will take questions from equity analysts.
Before we begin 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 company's filings with the SBC.
This includes without limitation, the company's forms 10-K and 10-Q.
Identify the specific factors that may cause actual results or events to differ materially from north described forward statements.
[laughter] 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 inability to obtain future capital and maintenance of intellectual property rights.
And with that I'd like to turn the call over to Dr. misleading.
Thank you. Thank you everyone for joining us on today's conference call to you our third quarter financial results.
And share with you some clinical updates so on the next to 73 or black comedy.
During the last quarter since our last conference call. We have continued to advance our clinical programs with several key milestones accomplished.
Just yesterday, we announced having received compassionate use.
After access team approval to ask somebody these patients continue treatment with Anavex 273 by the US trading and government Department of Health Therapeutics got good administration TJ.
This is certainly an important milestone and we honor to support medical professionals and their patients seeking treatment, while our communities and we have very few medical options.
In June we received approval from both the Canadian and the United Kingdom Health authorities to expand the footprint of the international case to be stressed we double blind randomized placebo controlled safety and efficacy trial I wanted to 72 here for the treatment of early October disease.
Into Canada, and the UK, respectively.
Adding these global region is expected to continue steadfast to even accelerated enrollment of this important outcome studies. These trials.
Also adding international footprint in North America and Europe.
We announced in June the complete enrollment of the Anavex 273, U.S. phase two Rett syndrome trial.
The enrollment target was who passed by 50% with 31 patients now enrolled in this trial, we expect to announce topline results from this study in Kolenda Q4 2020.
But the more just last month, we announced the first patriotic patient was dosed in the third study of Rex syndrome program the excellent trial.
This phase two centsthree trial will evaluate the safety and efficacy or on the VIX, who said three in over 69 patients pratik patients with Rett syndrome.
Page five to 18 over a 12 week treatment period, incorporating on the next 273 specific precision medicine by markets.
We will also pleased to report in July that the first participant was enrolled in a phase one clinical trials analytics, we tell anyone with focus on the treatment of Frontotemporal dementia SPD for which on the next 371 was previously granted orphan drug designation by the FDA.
The phase one clinical trial is a prospectus double blind randomized placebo controlled study. This study will be followed by longer duration dosing, including FTD patients and incorporating exploratory efficacy in disease biomarker measure.
Topline data is anticipated in the first top of 2021.
Finally, parkinson disease dementia topline results from the phase two study are forthcoming and are expected to be announced during this fiscal quarter.
And now I would like to direct to call to Sunderbans principal financial officer of Opex for breed financial summary of the recently reported quarter.
Thank you Christopher and good morning, everyone.
We reported a net loss of 6.5 million or 11 cents per share during the quarter.
As compared to 6.5 million or 13 cents per share in the comparable quarter of fiscal 2019.
Our general and administrative expenses remained consistent quarter over quarter at $1.4 million.
Research and development expenses were $6.7 million for the quarter ended June Thirtyth 2020, an increase of point 9 million over the comparable quarter in 2019.
This increase is the result of increased clinical trial activities and the continued advancement of existing clinical trials.
Our cash position at June Thirtyth, 2020 was 27.6 million compared to 22.2 million at September Thirtyth 2019.
Thank you and now I will turn the call back over Christopher.
Thank you Sandra in summary, our to point out that despite these challenging times, we continue to make steady progress.
It was fiscally responsible.
Work to whats, reaching several important milestones and we're poised to an exciting time ahead with multiple data read out ahead of us.
We look forward to providing further update as than men continue.
Now I'd like to open the call for questions. Operator. Please go ahead.
Thank you we will now begin the question answer session. If you have a question. Please press Star then one on your question.
If you wish to be removed from the Kim Please press the pound sign hash key.
If you're using these speaker phone you may need to pick up the handset first before passing the numbers. Once again, if you have a question. Please press Star then one.
And our first question and trying to Charles Duncan from Cantor Fitzgerald. Your line is open.
Hi, Good morning, Christopher Thanks for taking the questions and congratulations on the progress in the quarter.
Wanted to ask you a couple of questions first of all regarding the PD cognition study.
What would you look for out of that study too.
Ill give you confidence take continue to invest in that particular indication it seems like.
PD is or particularly can cognition in PD is somewhat of a heterogeneous indication I just wonder a month, but you how you would define success.
We.
During the study from background that we had a signal in our phase two a us somebody sees cognition.
Study.
And we then had impaired though a microphone foundation.
On the preclinical study in a animal model of disease modification of Parkinson's.
So when this data came together in the outcome. We're considered sufficiently positive to explore these features in one study that's where the advice from advisors certificate by this will microphone foundation came about to do and execute this study so it's.
The combination of looking for cognition, but also looking for features of parkinsonian disease.
That can be.
Alleviated with the drugs on the next we set of three and we decided to shift to focus on dimension talk to the primary endpoint is looking at the dementia domain in the secondary endpoints are those which are more considered the parkinsonian impairment like you PDR as as well as.
Leap act to growth.
And that data, including in multiple impediment.
Teach us as well as very heavily biomarker.
The increase including biomarker measure, which given goes beyond the classical biomarkers.
Because we also including the entire genome, including the are in a and B DNA. So I think once we have the data will be able to hopefully be very aware of what's going on in this study.
Yes, so just if I could follow up so you it sounds like kids look for a signal in terms of.
That dementia component or or cognition components. So you look for that and and perhaps you'd look for lack of signal or impact on you pdrs in terms of.
Impairment.
Would you would you hope to see any improvement I mean, I I could easily see you seeing some improvement and for example sleep parameters.
Right, we don't want to exclude anything we just really take this very objective study to look at what happens in the study when treated with on a big so simply versus control and does this what we when we look forward to seeing.
So it's very much a signal seeking study you don't have any any.
Oh, a bias is in terms of effect size or anything that you that your that you're thinking about.
Right, we just want to see a signal first and that could be however, it is and that would be then suddenly we can move from there by sharing with the.
Thats already bodies and and take it from the essence, it's highly unmet need since now almost 80% of both hokanson patients develop that John.
Okay, and I think you mentioned that data should be by the end of September.
Well, we said this quarter and also it will definitely be this quarter.
I want to go in more specifics, we will report exactly when we have the data.
Yes, that's cool last question then regarding the first direct studied the U.S. phase two can you provide any color on the types of patients that were enrolled any characteristics that kind of on broadly can help us understand.
That that study.
Enrollment and what you'd look for out of it.
Yeah. So we had the benefit of having already a Glenn all the data in the first cohort, which was the PK Claude of six patients.
In this board we saw that day was a signal already which correlate to really nicely with the biomarker over disease specific biomarkers the glutamate levels.
And.
We make sure that because this is also a.
Complex disease that we include patients, which are able to show a improvement over the various pino types of the disease, which is very broad it ranges from movement impairment two.
Features or a cognitive impairment of response of seizures of sleep impairment.
Of stock living and breathing impairment. So you want to make sure that you include patients would have some level of dysfunction in a rather than to be able to discern in effect with the drug.
Sure.
And you feel like the enrollment.
And consistent to the protocol.
Requirements.
Yes. So we have made sure that we always look every patient being specifically matching the inclusion exclusion criteria.
Yes.
And beyond just the age restrictions I know in in your other studying you're doing pediatric patients tied to 18, which is in itself for bake a big range.
But beyond that when you think about the sample for that first U.S. trial, how does add sample relate to the broader set of patients right patients does do you think that you've captured a fairly good sad or good.
Broad coverage on a entire population are you hitting a certain niche that really can be useful to determining the potential use of two sub three in that population.
Yes, so the U.S. studies 18 years, an older and it sounds like very generous but the.
Additive, there's actually a less patients a pool for study of able in older patients.
For various reasons.
And we basically are happy that we were able to enrol, especially in the last few months.
Many more patients than we had actually plan for because we just had to them for 21 patients at the beginning and then we ended up 10 megawatt to end up now at 31, which is very beneficial for a calculation of the.
The efficacy and so we were very pleased about that without having a to give up any on the quality of could patients participates in the study.
So what we know from.
Scientific experience is that it is usually harder to find a change of phenotype in the old at the patients are especially in your development to be the so that means gap. If you treat earlier, it's likely that you are able to five.
So the fact that we already saw something the first six patients in adult in the adult study.
But also with the lowest dose it's kind of very encouraging.
Yes for sure, but it is it's a heterogeneous patient population sounds like and again should be viewed with.
Perspective that its signal seeking not certainly not this positive.
Well I think we again see what what to what will be the outcome. We had a very strong and effect size in the first six patients.
I don't know if we can use that as the benchmark for the entire study it will be great. If so that would play out in the study and think we will see when this study will result, which is as I mentioned by the end of this latest.
Perfect. Okay. Christopher Thanks for taking my questions, we'll look forward to data flow over the second half the year.
Thank you.
Your next question is from Ram from H.C. Wainwright Your line is open.
Good morning. This is mark speaking on behalf of from Thanks for taking my question.
First query late to the PUC.
On.
Trial, and then I have a couple of follow up.
My question.
Purposely.
What do you think in times of.
Being the most crucial tasks in the pocket. These dimensions trial is would you say.
Well the Mds you Pbrs.
The phase two trials Austin, where the phase three trial by.
What was the last question if the phase two positive.
The phase two trial is positive with a single phase three trial the fives I.
I see.
So the answer to the first question. This TDR continue to you have attention is the primary endpoint and that is definitely the most relevant signal we're looking at full Parkinson's dementia.
The.
You'd be the RF is a hour a.
It come positive of multiple measures among them the movement among them also tongue churn and to certain extend activities of daily living so thats why its structured in different.
Subscales like no one two and three and three being the movement sub scale. So we believe that CDR conceal attention will give us the most important.
Signal.
For deep dementia pocketing dementia domain.
But also the other one would be interesting thats why we included as a secondary endpoint.
And in terms of your second question. If the phase two is positive we would shared with the FDA and then take the steps to them. They are.
What would be the right way to approval.
Well the appropriate next steps for seeking approval.
Hey, Mike.
The longer dosing study using the artery efficacy empathy biomark imagine being initiated.
Significantly.
As the longer dosing study using be exploratory efficacy and to be biomarker measures have that being initiated.
You mean, the extension when you say longer term.
Yes.
So we have in all our studies and extension so both the U.S. Rex aneurysm study as well as the pockets I mentioned study have an extension and so the extension for direct syndrome study is 12 weeks in the U.S.
One year the other custody.
And it will be also one you're in the excellent studying rett syndrome, and it's one you end the pockets of his Demetra study and its two years in the Optima to these last three study.
All these extension studies.
Have not only the biomarker, but also the underlying randomized placebo controlled studies have the biomarker, including could genetic.
And Alex to conclude it so we don't have to wait for weed out of the extension study to learn about that.
Makes sense.
And just finally.
The.
273.
Are you looking at other CNS disorders.
Epilepsy.
Right, yes, so when you when you.
When you look at our pipeline you might have noticed that we have also strong evidence of.
Animal.
Model.
For the Tory efficacy.
For Parkinson's for infantile spasm pro fragile X.
For 18 months syndrome, and these indication will likely be next in line and in case of we have a positive read out on the ongoing studies sold the franchise will expand into the indication saying.
This is something which practically has been shown to be already very.
Very strong signal with another six to cemetery.
Fantastic I feel very exciting thanks for taking my question.
Youre welcome. Thank you.
I didn't injection and have a question. Please press star then one.
Charles Your line is open.
Yes, hi.
I haven't heard anyone hopefully Christopher still on the line. Thanks for taking a follow up just one quick follow up on a pediatric program I'm. Just wondering if you could give us any further indication of the types of patients that you'd like to enroll and then obviously there are certain age group, but.
18, we can we can read watch on Clin trials, but I'm just wondering if one you've talked investigators.
There's a certain phenotype that that you would like to see enroll in that that could.
Give you.
Ill.
Confidence in the outcome, but also address really the under underlying unmet.
Needs.
Cynthia.
Patriotic study from five to 18 years old.
Is that relatively a comparable to the adult study.
Once the phenotype shows up in wrecks and drove it very much stays relatively stable.
And with Tom you know some variations of that so you looking at similar measures, including the.
Our Q procedure I and the sleep parameter of parameter and the question has actually identical in the adult is in the children because of the phenotype of direct population. The adult are still consider children. So we have in our excellent.
Got it because it's our largest study and geared towards a a pivotal study that's why it's a phase two centsthree we have more.
Measures included in a slightly longer so the adult studies are seven week in duration and it could traffic study is 12 week integration.
Okay. That's helpful. And then just if you could wax poetic if you will or speculate on on the competitive environment.
There are there are other programs. We did recently see one re commenced enrollment enrollment.
From the neuron Marin.
Acadia side.
We also now GW is doing some work and rat and it would seem to me that rent is.
Large unmet need but in an orphan disorder and I'm. Just wondering if you could give us a sense of the feedback you've gotten from the advocacy community on how to seven three fits within emerging treatment paradigm, assuming all of these programs are.
Our successful which is a begley, but the other thing is in terms of competition for patients in the in the programs.
So the.
Commented luck is is that from the very beginning we were fortunate that we were highly supported by the Red community. The foundation itself actually was instrumental in even getting us where we are without them. We wouldn't have had any data in rett syndrome to begin with.
The entire.
Preclinical animal model, where supported and financially support it in paid for by the foundation.
Without them, we wouldn't have that the data and then when the data was very positive in the animal model or correct syndrome. Then the decision was made by the wet foundation to also support our Wes clinic body. So I'd like to thank the recommendation for that very much.
We also made something.
Probably a very important distinction.
As we learnt also during the call good time, which was extremely advantageous in hindsight, we just didn't send out the protocol and started to study without feedback from the parents of over direct patient. So what we did we basically asked them what is important for you as a parent.
In your respective a girl.
To participate in this study we learned that visit in the hospital were considered very burdensome, so I basically.
Decided to then to limit the visit in the hospital and also adding.
Hey, Optionality in the protocol that every visit can also be.
At the home of the trial.
And that was interesting because when Colgate came along we were able to switch to that.
Manifestation of protocol Optionality and that also probably led to our ability to increase our enrollment.
Two by 50% instead of stopping than trial entirely who trying to attend other trials.
We're forced to do.
Yes, certainly that is.
Makes it less complex in terms of.
Interpreting the data, but it also seems like you facilitated progress with with the rack community and perhaps it will bode well for for the future.
And we plan to continue to do that both with the foundation year in the us very much but also abroad in Australia, we're working with the Rex community in foundation in Australia, as well as in Europe in UK as well so we really are.
Hand in hand, working towards this goal or making sure that we don't do this in a vacuum.
Yes last question is do you see Desmond see rat.
As being a challenge to Asian.
Communities in and is there any corporate strategy to broaden our potential access.
To those.
Those countries through maybe partnering or other endeavors.
There is indeed.
The same amount of Brett patients in Asia, especially in Japan, and China, but especially in Japan is the same amount of patient there than in the USA has so it's not about 10 to 15000 patients in in Japan alone and we do plan after.
The readout of the U.S. study, which is forthcoming two then move into the Japanese territory to also continue the.
The study with Anavex 273 indications.
In that regard.
And with those these studies you can doctor or do you think it may be best to do that in 10 in collaboration with apart.
Right. So you know Japan is a unique market where.
The entity is working has to be local so they are probably a mix of.
A local sponsor with us together or to us Euro we have not made a final decision on that yet.
Okay well.
Thanks for taking my follow ups Chris.
You're welcome.
No further questions at this time.
We have no further questions at this time.
So with that we thank everybody to participate and this concludes todays conference. Thank you very much for participating.
Thank you ladies and gentlemen. This concludes today's conference you may now disconnect.