Q3 2021 Anavex Life Sciences Corp Earnings Call
Good afternoon, My name is Adrian and I'll be your conference call operator today walk us the Antivax life Sciences' fiscal 2021 third quarter conference call. As a reminder, this conference call is being recorded.
Call over to your host for today's conference Claire Hamilton. Please go ahead.
Thank you and good afternoon, everyone. We appreciate you joining us today for <unk> Life Sciences third quarter Conference call to review financial results and discuss the company's business updates.
A replay of this call will be available after the call.
The call will also 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 Burnish principal financial officer.
Following management's remarks, there will be a question and answer session. 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 involved a number of risks and uncertainties. We encourage you to review the company's filings.
With the SEC.
This includes without limitation, the Companys 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 factors may include without limitation risks inherent in the development <unk> commercialization of potential products uncertainty in the results of clinical trials or regulatory approvals need and ability to obtain future capital and maintenance of intellectual property rights and with that I'd like to turn the call over to Dr.
Ms Lamb.
Thank you Glenn and we appreciate everyone joining us on today's conference call to review our financial results.
And describe the company's growth strategy.
Let me start by stating that we can proceed into the remainder of 2021 with a background of a strong balance sheet of over 157 million in cash and no debt.
Our team with our lead drug candidate <unk> 273, we expect to announce topline results from the confirmatory double blind placebo controlled late stage phase <unk> III study in Alzheimers disease.
Into Sop in second half 2022.
The double blind placebo controlled 509 patient late stage phase <unk>, three and <unk> III trial in patients with <unk> disease exceeded enrollment beyond 450 patients at 52 sites across North America.
Europe, and Australia, using Odyssey, caulk, cognition, and Adcs ADL activities of daily living and function as primary endpoints.
This multi center double blind clinical trial is measuring efficacy tolerability and safety of two different once daily oral <unk> with.
Three doses or placebo.
And of exclusivity three is an orally available small molecule activator of the Sigma one receptor data suggests activation of Sigma one resolved in the restoration of complete housekeeping functions within the body and is pivotal to restoring neural cell homeostasis and <unk>.
Neuroplasticity.
This study includes a prespecified precision medicine biomarker Sigma one gene expression, which demonstrated correlation with direct measures of clinical benefit cognition and activities of daily living and Pfizer.
In our previous piece to ultimate disease.
Patent data previous confirmed dose dependent target engagement of Sigma one with <unk> 273.
As a reminder.
Our clinical strategy is clearly differentiates it from other biopharma companies and clinical studies in CNS. Other VIX is continuing to pioneer the approach of big data and clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analysis.
As of whole exome sequencing and gene expression data in drug development and in particular, the potential to identify patients antique variance and gene expression changes that may predict increased chances of success of <unk> disease, Parkinson disease and ret.
Syndrome treatments.
<unk>, we can announce that we exceeded the enrollment target for the precision medicine, and <unk> 273 phase III <unk> III Avatar clinical trial in patients with Ret syndrome, and currently topline results from this study are expected in the second half of 2021.
The clinical milestones are provided in other ex life Sciences latest corporate presentation available at Ww W. W. Dot dot com.
And now I would like to direct the call to Sandra Burnish principal financial officer of <unk> Borg refinanced a summary of the recently reported quarter.
Yeah.
Thank you Christopher and good afternoon to everyone.
We can report a significant increase in cash runway.
Our cash position on June 32021, with $157.6 million.
Which we believe is sufficient cash runway to fund operations and clinical programs beyond 2025.
We reported a net loss of $10.2 million for the current quarter or <unk> 14 per share.
As compared to $6.5 million or 11 cents per share in the comparable quarter last year.
Research and development expenses for the quarter were $9 million compared to $6.7 million for the comparable quarter of fiscal 2020.
This increase is primarily attributable to the continued advancement of our ongoing clinical trials, most notably the full enrollment of our international phase two B class III Alzheimers disease trial.
And the continued enrollment and advancement of the international Ret syndrome program.
General and administrative expenses were $2.4 million for the quarter as compared to $1.4 million for the prior year period.
The increase is associated with the growth of our team.
Nonrecurring costs associated with our annual general meeting.
Thank you and now I will turn the call back to you Christopher.
Thank you Sandra.
We are extremely excited and we believe that <unk> has never been in a stronger position than it is today with our recent double blinded placebo controlled study result, correlating with predictive biomarker outcome.
And the strongest balance sheet to date and the further strengthening of the analytics team in.
In summary, we believe we are positioned for further growth and expect a catalyst rich upcoming 12 months.
So we look forward to providing further updates.
Management continues.
I would like to now open the call for questions. Operator. Please go ahead.
Thank you.
At this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press Star then one on your telephone keypad.
Yeah.
And our first question constant Charles Duncan from Cantor Your line is open.
How are you doing this as a pizza who is on for Charles good.
Good afternoon, Christopher and team congratulations on the progress and certainly appreciate all the updates.
So I have one question.
Regarding the Ret program.
Do you think about the efficacy measures that were made in and we're seeing the efficacy seen in the U S. Adult study, how do you sort of feel about the sample size for the planned effect size out of avatar.
So we all have been observed in the U S. Rex study at a low dose study a five milligram daily orally that effect size in the RFP queue was 1.1, Cohen's D, which is considered a very large and for the atom score.
It was even larger one three so these are very large effect sizes.
In the Avatar study, we even have a larger population in the placebo controlled study and the doses are higher than five milligrams. So we expect if there is a dose response curve, which positive dose response curve, which.
Right now assume it is to be the case that this effect size will be sufficient for a positive readout in the avatar study as well.
Thank you for all that.
And another question I have regarding the Ret program.
In clinical trials Dot Gov. The pediatric excellent study states that the estimated completion date is about November of 2021 are you still on track to complete the study by that time and the reason why I'm asking is I know that I believe that you have a large part of it is being conducted in Australia and now Unfortunately, theyre going back into the lab.
And some parts because of Covid.
This is right now still enrolling well and the ability to continue the trial is still the case, what we cannot.
No for certainty how much enrollment is impacted by these.
Current situation in Australia, but we still believe as of today that the timelines are accurate to be able to complete the trial.
The stated timeframe, but if this will change we will update accordingly.
And just one last question.
On the Alzheimer's program.
Provide some color on the rollover rates.
For the phase <unk> III study into the open label extension.
We were really.
Very impressed with the very high rollover rate onto the open label study, which was over 95%, which is extremely high and we also have been in.
Informed that the patients who now are reaching the end of this extension study open label have requested.
And the respective caregiver to stay on study drug and so we have now being able to also extent because of this request the open label study.
Hi.
The period of time for allowing the open extension study to give these patients continued access to study drug.
But I want to point out that does not affect the timeline of the placebo controlled study. So it's just in parallel.
The ability of the patients who finished the placebo control study to stay on study drug without interruption.
Good it's probably perceived benefit and.
Probably reflects a lack of tolerability issues. So thank you very much for taking my questions and congratulations again.
Thanks.
And your next question comes Jim how much Rice chunk research your line is open.
I apologize that summit right from Jones trading.
Hi, Thank you for taking my questions first question on the.
The adult Avatar study.
Do we have an idea if.
When youre, having FDA conversation and.
If the trial size needs to be modified to turn into a pivotal trial. If you can give us any color on that and also some.
Color on the dosing.
For both the Arbitron excellence studies, what kind of dose cohorts that or should we expect.
Right. So we are.
In the dialog right now with the agency, we have fast track designation and orphan drug designation as well as the.
Voucher.
The ability for Ret syndrome with <unk> III. So we right now in dialogue with the agency and I would like to provide.
Provide an update.
With updates as soon as we have that that would be.
More in appropriate.
The second question is.
Regarding the doses, we have a higher dose than five milligram and we have used a dose of up to 50 milligram in the.
<unk>.
Patrick Parkinson's dementia study and in the Ultimate study, but the reason why we are keeping this.
Dosing specifics right now.
Within the blinded information is because this study is in a population which is very new to this.
And we are concerned that they might be between the family interactions, which could lead to some.
On blinding of the study or under virtually to learning about the <unk>.
Effect of the drug in May.
Our calculation back on the envelope if more drug is given how much the effect would be based on the existing.
<unk> data of two five milligram arm. So that's the reason why we keep this right now blinded, but we will obviously disclose it when we have the data, but it is higher than the five milligram dose.
I see it very interest income.
And.
One last question on the Alzheimer's trial.
Could you give us any color on the.
Baseline M. A C. L piece patients it seems like a wide range 20 to 28, what should we be expecting more early stage are mild to moderate enrolling in Europe piece to be three trial.
Alright, so the rationale for that range was we have seen in the phase two a prior the very positive response across the entire.
M. A C baseline score, which started from 16 to 28, but we noticed that the patients.
<unk> 'twenty MMS ive had the ability to improve.
From baseline on a net positive to <unk>.
Reverse the disease symptoms. So the cognition was improved in not only the ability to show a delay of the cognitive decline.
All the patients below 20, MMC, we're able to stay on a stable a score. So the other reason why we included 20 and higher is that these patients are better.
Still in a better way to comply with the trial regimen.
You have more advanced cognitive impairment often that is not the case, but the mutation is really like.
<unk>.
Broad average within this.
As to the score.
Between 20, and 28, which is really also the identified.
Ah patient population now.
Now called early Awesome, a disease, which is probably the majority in the highest unmet need at ultimate disease today.
I see so you would.
You want to break it up into two groups. He would keep he does the entire 'twenty to 'twenty two groups and that's how you will present the data.
Because we saw that there was no difference of the improvement. If you were 28 <unk> 20 in both cases, we saw with <unk>.
Corporate dose and improvement of the score.
Got it. Thank you so much for taking the questions and I'll hop back on the queue and congrats again on the progress.
Thank you.
And your next question comes from Ram <unk> from H C. Wainwright Your line is open.
Thanks, very much for taking my questions first of all again alluding to the potential role of block canvassing and Alzheimers disease can you comment on some of the preclinical information that's been presented recently and whether this would potentially point to a protective role for block Compazine any.
<unk> if you can speculate on.
Which population.
The use of block M is seen as a protective might be most relevant from a clinical perspective.
For example, those people who are.
Existing signs of prodromal, Alzheimer's disease, or mild cognitive impairment I understand that it's an early stage at which to be thinking about that but just wanted to get your thoughts in this regard.
I appreciate the question we have learned in a.
Diseased.
In a preclinical animal model of prevention.
So basically you gave two healthy mouse mice the drug for seven days every day for seven days they'll stop the treatment and then object.
A depth into the brain, which is unknown.
Animal models to pathology and then these animals, usually they basically they get sick they lose cognition.
You see that in the measures.
What amazed behavior, and so forth and we noticed in the arm, which had been given this seven day.
Pretreatment prevention.
That these analyst never developed after the engine with a better any symptoms of cognitive impairment they behaved.
Lee.
Sure.
Ah Stewart as their wild type parts.
But those who were given the a better and without the pre treatment.
They develop cognitive impairment.
We expected from the animal model. So this is the observation, which led to the to the potential ahead.
But one activation without a X two semi III, which as we know by now is extremely upstream and profitably able to prevent.
The cellular stress, which is caused by the better.
Into rejection.
And so and the entire challenges of the pathology, which is not limited to eight that's up that this could be used as a prevention.
Also.
In the future has to be awfully confirmed.
The Telegent, we havent. The Optima study seems to be also giving credibility in that direction since we noticed a gradual ability to improve that.
<unk>.
Yes stage status of the creative.
Capacities, so when I mentioned before the cognitive impairment lower than 20 M. A C and the lowest score means more cognition or more cognitive impairment.
Bill cognitive impairment that those speeds were better off the earlier you treat them, so we might be able to.
Continued to.
The trajectory of into the ability to prevent the cognitive impairment to even take place when we give the drug to patients which are either as you pointed out mildly cognitive and pad or before even any symptoms of cognitive impairment is present just to be able.
To always prevent these cellular stress by this.
Activation and re competes in a way too many aspirin, which some people take for avoiding cardiovascular problems and they do that every morning for breakfast. So I'm not saying that this is confirmed in humans, but eventually we will be able one day to tackle that.
And that is the plan in a study.
Great. Thanks, and then also I wanted to ask about your thoughts regarding lessons takeaways from the reps syndrome experience with block common theme and their applicability to your potential clinical development initiative with the compound in fragile X syndrome.
If you could also give us a sense of when you anticipate the fragile X syndrome program to initiate patient enrollment. Thank you.
We have included in our Red syndrome clinical trial, a measure which is called Adams ended score is interesting enough secondary score in the Ret syndrome study, but it is often used as a primary endpoint in fragile X studies and the Arabs Globe was extremely positive.
With behavior improvement of.
General and mood of insight.
And compulsive behavior improvement, which were very significant and very broad and global so we believe that in a.
Data readout of the preclinical data on fragile X with <unk> 73, which we submitted to a peer reviewed paper of our nature paper, which we expect to come out us forthcoming.
This could be.
Very good.
Basis for the rationale not rationalizing progressing fragile X.
<unk> a indication of choice also for <unk> 273, and the ideas to move this forward.
As soon as possible given the unmet need of fragile X, which is the largest population of autism spectrum disorder and Tourette syndrome is also part of the family of the autism spectrum disorders. These are.
Correlated.
Jesus, although they originated in different places in the.
And the conversation in the causality, but they have similar symptoms.
Overlapping symptoms.
With each other so we expect the.
The trial to be initiated.
Initiate it.
Once we are able to showcase the data in a peer reviewed paper.
Thank you very much.
And our next question.
Tom Bishop.
Research.
Alright Christopher.
You said that you expect it to include a phase III prevention study.
Or to initiate one.
For the prevention indication and I was wondering what the status of that was and how soon we could expect that.
So this is something which we would like to discuss with the agency because its sort of leader very important study and we want to get that right. So we will let that happen first before providing more details on that but I'd like to just point out the potential for that to be the case and that gives us.
Also a great hope that given the broad.
Upstream effect of the Sigma one activation, which is I want to remind everybody it's not something.
We came up with but it's really the endogenous to body on defense mechanism to avoid and to prevent cellular stress, which causes diseases like Alzheimer's, but also parkinson and other cognitive impairment indications and probably also the.
Degenerative and as well as the.
New developmental vacations.
Which is the reason why we see it as strong effect beneficial effect with the drug in this broad therapeutic different indications. So this is something we'd like to discuss with the agency first before making providing more details but this is the long shot and this is probably the big prize.
One day this could be used as a prevention treatment for all degenerative diseases and not only for treatment.
That's a very exciting possibility.
What is the status of the meeting.
Perceived on the phase III in Parkinson's that sometimes it seems like we lose a lot of time between trials I know you've presented the final.
Data.
I'm just wondering what the timeline is here too.
The meeting with the FDA or.
I had one or.
This is a very good question.
The key background as to know that the trial itself has finished but the analysis is not limited to the endpoints, which we reported there are more work Oh look up ongoing right now and this is also unique for other VIX and differentiates other companies that we have included in our trials include.
Adding the PDD trial to pockets of disease dementia trial, the whole genomics exome analysis, both DNA, but also RNA and you know that we reported the RNA changes of the Sigma one gene what we have not yet done is they have the intelligence on the RNA of all.
All the other genes, which is the whole genome. So there will be so much more intelligence from this PD study, which we just right now putting together and once we have that then we will have the ability to put this all forward because this will determine a much more robust phase III design of a.
Pivotal study in Parkinson's dementia as well as in Parkinson, but that requires also the dialogue with the agency first but before that we have to have the entire data at hand.
Well okay.
The status of the Michael J Fox million dollar of imaging study.
It is Michael J Fox doing that independently of you.
When you're supplying the drug but they're doing the imaging I mean, how is that going.
No it's basically a grant.
That allows us to do the study and we are in the process of starting this this year.
The study, which will capture the imaging and the profile of the <unk> three of the drug in the brain in the humans with the same pet ligand, which we have done already in animals. So this will be a confirmatory.
That effect in human brains and that is the study which was fully funded by Michael Fox Foundation, which we are executing and they basically funded that study with a grant.
Oh, I see okay, and you indicated the mystery indication earlier this year.
And also there is a 371 trial.
If things one ongoing could you comment on those two.
What I'd say I don't know.
Right, it's not a mystery indication we have only said we have not disclosed yet the indication we have several animal models, we have analytics to simply three has been positive.
Very well.
Achieving a.
Confirmatory effect on disease, which is.
And nature of ultra rare nature, and we want to make sure before we move forward with the clinical trial that we pick the right one to do because we have the choice of several indications and we do.
Doing this right now so once we have that completed that assessment, we will disclose that indication and start that trial also right away and regarding <unk> 371, its basically another molecule had its own.
IP and that is now in a phase one and we expect data readout in the second half of this year is progressing well and we are excited because it confirms the.
Validate the mechanism of action of our platform portfolio to focus on SYGMA won a modulation and also it has received.
Orphan drug designation for <unk> for frontal temporal dementia, which is also an admit need. So we are now preparing after the phase one the next stage of that which will be a study in a indication of cognitive impairment it could very well be a frontal temporal dementia or another indication.
With an unmet need with cognitive impairment.
But the phase one study is are you, saying it's done.
It is about to wrap up and we will be able to report this data in the second half of this year that's correct.
Will that include any efficacy data.
Safety trial early.
It's predominantly a safety trial, but I will.
Bill.
Now allow us to basically share that data once we have it and that gives us better.
Visibility on what is included in that.
And the outcome measures beyond.
Phase one data.
On safety data.
Okay, well you know ive been very encouraged by the breadth of the positive Readouts youre getting on a variety of indications and I think that helps support the idea that.
It really does something in the brain.
Which I think you have little doubt of and I do too, but it's just good to see so many different positive readouts coming.
Thank you if I might add it is really important to notice and to highlight the fact that in all clinical trials. We have performed so far not only was unaffected several III efficacious at the right doses, but it also demonstrated a dose response curve, which is always a very clear indication of.
Effect and thirdly, we have noticed that all the data all the trials so far.
<unk> had a very strong biomarker of response, a predictive biomarker response, which was borne by the.
By the.
Level of mrna expression of the target of our drug itself. So there's really no better way of showing efficacy and confirming efficacy of a drug with these strong biomarker outcomes, which correlated with all the primary and secondary endpoints of the trial we have performed.
Well like I said, it's very encouraging alright. Thank you.
Thank you.
Thank you ladies and gentlemen. This concludes today's conference call you may now disconnect.
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