Anavex Life Sciences Corp. (AVXL) Q2 2024 Earnings Call Transcript

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q2 2024 Earnings Convention Name August 6, 2024 8:30 AM ET

Firm Individuals

Clint Tomlinson – Investor RelationsChristopher Missling – President and CEOSandra Boenisch – Principal Monetary Officer

Convention Name Individuals

Tom Bishop – BI ResearchSoumit Roy – Jones Analysis

Clint Tomlinson

Good morning, and welcome to the Anavex Life Sciences Fiscal 2024 Third Quarter Convention Name. My title is Clint Tomlinson, and I might be your host for immediately’s name. Presently, all members are in a listen-only mode. Later, we’ll conduct a question-and-answer session. [Operator Instructions]. Please word this convention is being recorded, and the decision might be accessible for replay on Anavex’s web site at www.anavex.com.

With us immediately is Dr. Christopher Missling, President and Chief Government Officer; and Sandra Boenisch, Principal Monetary Officer.

Earlier than we start, please word that in this convention name, the corporate will make some projections and forward-looking statements. These statements are solely predictions based mostly on present info and expectations, and contain quite a lot of dangers and uncertainties. We encourage you to evaluate the corporate’s filings with the SEC. This contains with out limitation, the corporate’s kinds 10-Ok and 10-Q, which determine the particular components that will trigger precise outcomes or occasions to vary materially from these described in these forward-looking statements.

These components could embody, with out limitation, dangers inherent within the growth and/or commercialization of potential merchandise, uncertainty within the outcomes of medical trials or regulatory approvals, want and talent to acquire future capital, and upkeep of mental property rights.

And with that, I would like to show the decision over to Dr. Missling.

Christopher Missling

Thanks, Clint, and good morning, everybody. Thanks for being with us immediately to evaluate our most not too long ago reported monetary outcomes and to supply our quarterly enterprise replace. We proceed to meaningfully advance our differentiated precision medication medical program, highlighted by the current presentation of complete outcomes from the Section 2b/3 medical trial, blarcamesine, ANAVEX®2-73, which represented on the Alzheimer’s Affiliation Worldwide Convention AAIC, displaying that oral, as soon as every day blarcamesine considerably slowed medical decline for early Alzheimer’s illness, sufferers with good comparative security profile and/or related neuroimaging adversarial occasions.

Full knowledge from the blarcamesine examine in Alzheimer’s illness Section 2b/3 placebo managed medical trial might be revealed in an upcoming peer-reviewed journal. The initiated course of for submitting a Advertising Authorization utility, MAA, to the European Medication Company, EMA, beneath the Centralized Process is underway with full regulatory submission of blarcamesine anticipated in This fall of 2024.

The Advertising Authorization would enable direct market entry all through the European Union for oral blarcamesine for the therapy of Alzheimer’s illness. There are an estimated 7 million individuals in Europe with Alzheimer’s illness, a quantity anticipated to double by 2030, in accordance with the European Mind Council.

Evaluation of RNA sequencing RNA-seq, which might reveal which genes are actively transcribed or in different phrases expressed in Alzheimer’s sufferers compared between placebo and blarcamesine of the placebo-controlled Section 2b/3 blarcamesine trial in early Alzheimer’s illness in underway. This knowledge might need related worth, since it might present perception into Alzheimer’s illness pathology and the way cells perform within the presence of placebo or in presence of blarcamesine, respectively. Interim knowledge is anticipated within the second half of 2024.

In June we accomplished the final affected person final go to within the ATTENTION-AD open-label extension 96-week trial. Interim knowledge from this trial is anticipated within the second half of 2024. The rationale AAIC 24 assembly resulted in constructive suggestions coupled with enthusiasm round our Alzheimer’s illness program strengthened by the current addition of an skilled medical staff, which assist Anavex future plans. Academic outreach to proceed as work in the direction of MAA submission and past.

We’re additionally happy to report that the medical staff continues to beat the deliberate timelines within the ongoing Section 2 medical trial of ANAVEX®3-71 in schizophrenia sufferers. We’ve accomplished dosing of the primary cohort and are nearing the completion of enrollment of the second cohort of schizophrenia sufferers in Half A of the trial.

In Parkinson illness, initiation of ANAVEX®2-73 Section 2b/3, an over six months trial, together with biomarkers, which we imagine could also be key for understanding drug impact on Parkinson illness pathology and account for the not too long ago altering context within the discipline of Alzheimer’s illness of Parkinson illness is anticipated within the second half of 2024.

In Rett Syndrome, an academic presentation was offered on the 2024 IRSF Rett Syndrome Scientific Assembly, going from June 18 to June 19, 2024, which demonstrated the dedication of Anavex to the Rett syndrome neighborhood via direct engagement with sufferers and households. Constructive and supportive suggestions was acquired from households and investigators in regards to the continued Anavex Rett syndrome program.

Concerning Fragile X, new disease-specific translatable, and goal biomarker knowledge generated with ANAVEX®2-73, supporting the initiation of the ANAVEX®2-73 Section 2/3 medical trial was offered on the nineteenth NFXF Worldwide Fragile X Convention. Assembly with the NFXF management staff strengthened Anavex relationship with neighborhood coupled with elevated consciousness of Anavex Fragile X syndrome program by participating with sufferers and households in attendance.

We’re additionally anticipating the initiation of Anavex Section 2/3 medical trial in a brand new uncommon illness sooner or later. Lastly, we’re constructing medical affairs capabilities to develop schooling and doctor assist actions to make sure optimum medical impression, together with continued medical publications involving ANAVEX®2-73 and ANAVEX®3-71.

And now I want to direct the decision to Sandra Boenisch, Principal Monetary Officer of Anavex, for a monetary abstract of the not too long ago reported quarter.

Sandra Boenisch

Thanks, Christopher, and good morning to everybody. I am happy to share with you immediately our third quarter monetary outcomes for our 2024 fiscal 12 months. Our money place at June thirtieth was $138.8 million and we’ve no debt. In the course of the quarter, we utilized money and money equivalents of $5.2 million in working actions after making an allowance for modifications in non-cash working capital accounts.

At our present money utilization fee, we imagine we’ve a money runway of roughly 4 years. Throughout our most up-to-date quarter, normal and administrative bills had been $2.9 million as in comparison with $2.8 million for the instantly previous second quarter. Our analysis and growth bills for the quarter had been $11.9 million as in comparison with $9.7 million for the instantly previous second quarter.

And lastly, we reported a internet lack of $12.2 million for the quarter, which is $0.14 per share.

Thanks. And now again to you, Christopher.

Christopher Missling

Thanks, Sandra. In abstract, we stay devoted to growing medicines for people affected by mind issues inside neurodegenerative and neurodevelopmental issues, which might additional develop our differentiated precision medication platform to ship scalable remedies coupled with handy oral dosing.

I’d now like to show the decision again to Clint for Q&A.

Query-and-Reply Session

A – Clint Tomlinson

Thanks, Christopher. We’ll now start the Q&A session. [Operator Instructions]. And the primary query comes from Tom Bishop, BI Analysis. Tom, try to be…

Tom Bishop

Hey. Are you able to hear me now?

Clint Tomlinson

Yep. Nice. Thanks, Tom.

Tom Bishop

Okay. I had a few questions. What are your plans to satisfy with the FDA or regulators in Asia, which you additionally alluded to not too long ago, as you probably did earlier with EMA and has a date been set for both or is there some kind of maintain up or extra knowledge you are ready for?

Christopher Missling

Thanks for the query. There isn’t any maintain up. There’s solely the main target proper now on the e-mail submission, which takes quite a lot of sources. We’ve to submit and put collectively a package deal of many modules, which is — might be so many pages and paperwork. So we concentrate on that. However the time will come, we do not know but when to additionally meet regulatory our bodies world wide, together with the company on this nation as nicely.

Tom Bishop

Okay. Close to the current presentation on the AAIC of the Section 2b/3 knowledge, the query comes up with regard to various variety of sufferers included in several measures that the corporate offered. And I’ve assumed that you just — it is simply merely on account of the truth that you may’t pressure sufferers within the trial to return in and take sure checks, particularly extra invasive ones, and that this explains it. However, in fact, the darkish facet likes to assert cherry selecting. So are you able to focus on this facet and put the problem to relaxation as as to if you do something with the information that is given?

Christopher Missling

Could I perceive higher to speak in regards to the variety of sufferers, in every go to, schedule visits?

Tom Bishop

Within the various things like Cog13 and no matter that you just offered in to the AAIC. So the variety of sufferers, a few of these.

Christopher Missling

So it’s a time level? Sure, so it is a — there isn’t any different technique to clarify it that each affected person doesn’t at all times current on the time level in query. He can skip. He might be impaired due to COVID and this trial was throughout COVID. It is very regular. You simply should then at all times account for when you may have a knowledge level, and that is precisely described within the presentation. And once you lookup different papers from [indiscernible] from Lecanemab, Donanemab, they’re precisely the identical. Each quantity is completely different at each time level as a result of they aren’t at all times the identical quantity of sufferers attending the go to. In order that’s a quite common process.

Tom Bishop

However you utilize the information precisely as given to you by the biostatistical agency? And who was that?

Christopher Missling

Sure, in fact. There isn’t a different method than to take each accessible knowledge level. There isn’t a different method to do this apart from that.

Tom Bishop

Okay. And I wished to clear up or verify for myself this the so known as, the $150 million inventory providing that the assorted information headlined, that was only a shelf providing for use as wanted opportunistically sooner or later. Appropriate?

Christopher Missling

So the corporate has been extraordinarily cautious with, financing. We have been very conservative. Whereas different firms spent ton of cash, we have been very diligent on being very cautious with our fiscal accountable conduct. So what we did was simply to guarantee that at some point sooner or later, once we do want extra sources for market entry or different causes that we’ve that in place. So it isn’t meant for use immediately or tomorrow, however the alternative might come up. But it surely was simply to place in place one thing, so we’ve it in place for the long run.

Tom Bishop

Okay. And concerning Rett, is there a date to provoke one other Rett trial? Or nicely, I am unsure what was happening there?

Christopher Missling

So we’ve had superb suggestions from the convention I discussed, and there is not any date but. However we proceed as we acknowledged to do a bigger examine, for Rett Syndrome as nicely.

Tom Bishop

Okay. And at last, almost about Fragile X, was there a Section 1? You talked about going to a Section 2b/3, I feel and…

Christopher Missling

And Section 1 was accomplished with Blarcamesine with ANAVEX®2-73 already, so we are able to begin right into a Section 2 due to the Section 1 was already accomplished previous to this due to the drug was already examined in human wholesome volunteers.

Tom Bishop

Okay. And, truly, I had yet another. Close to Schizophrenia, are you able to remind us slightly extra or clarify the primary cohort, the second cohort, Half A, is there a Half B? I imply, might you simply run via that once more?

Christopher Missling

Certain. So Half A is a sign ascending doses. So we take a look at the tolerability of the sufferers for the primary doses, decrease dose and a better dose subsequently and the second greater dose is now virtually accomplished enrollment. And the Half B might be a longitudinal examine run about, I feel it is 28 days or so. So the drug might be given on the dose which might be thought-about the perfect tolerated dose, and we’ll then observe sufferers over an extended time period.

Tom Bishop

So the second dose is the upper dose?

Christopher Missling

The second dose from Half A is the upper dose, and Half B would be the dose which we select. As soon as it begins, and it will be an extended trial of 28 days or 4 weeks, principally.

Tom Bishop

All proper. Thanks.

Christopher Missling

Thanks.

Clint Tomlinson

Thanks, Tom. Our subsequent query comes from Soumit Roy at Jones Analysis.

Soumit Roy

Good morning everybody and thanks for taking the query. And likewise congrats on executing on a number of fronts. On the AAIC knowledge, Alzheimer illness, might you give us slightly colour, make us perceive on the dose dependency or a transparent lack of dose dependency between 30 milligrams and 50 milligram? There was ADAS Cog was working slightly higher for the 50 milligram versus CDR-SB for the 30 milligram. And the discontinuation fee are, so what % of the 50 milligram did you see needed to cut back to 30 milligram due to adversarial occasions within the open label extension?

Christopher Missling

So let me tackle the primary query first. So the 2 arms are these teams, and we use the expression for that cause. Once you learn our description within the presentation, we speak in regards to the dose teams, 30 milligram dose group or 50 milligram group. So since we enable titration to the perfect tolerated dose for these two arms in addition to placebo, by the way in which, we principally realized that the top of the day, the goal dose for many sufferers was comparatively shut to one another in these two arms. So whereas within the 50 milligram group, there have been some with 50 milligram, there have been additionally some with 30.

So it was a bit greater than the 30 milligram group, however not by a lot. In order that they’re just about shut, and that is why I additionally prespecified the 2 arms collectively towards placebo in a predefined evaluation. In order that was the background. So we’ve seen previous to {that a} dose response curve in our Section 2A. So there is not any doubt in regards to the dose response is confirmed. However what we now discover is that on this trial the place we and that is coming to the second a part of the query, the place we seen the place we pressure sufferers to uptake trait to the goal dose 50 in a short time inside two weeks after which to 3 weeks, we seen that did not — was very nicely acquired.

Some sufferers had some dizziness, they usually would not really feel comfy about it. So as a result of they are not impaired sufferers, they’re early Alzheimer, they felt saying perhaps we’ve COVID. I do not wish to proceed this. It was through the time of COVID, in fact, as nicely. In order that’s why we had some dropouts on the greater dose greater than within the decrease dose group.

So what we now realized once we did the open label examine the place we allowed a extra, I’d say, lenient and fewer stringent method of up titration in additionally permitting sufferers to take the drug at night time time as a substitute of within the morning, which we principally pressure sufferers to take through the trial early within the morning. So we seen that there was a lot greater tolerance for both dose 30 or 50 so long as they had been allowed to get used the drug for an extended time period.

And we seen that additionally within the Compassionate Use program with this extraordinarily greater tolerance with permitting sufferers to titrate to 50 or 30 so long as they’ve sufficient time to do this after which taking additionally night time time dosing. So we do not see the adversarial occasions, we’ve seen on this trial as a result of we principally compelled them to titrate so shortly as much as the goal dose. And we additionally should level out that it is truly a clearly manifestation of a manageable and addressable adversarial occasion. It isn’t like, once you take a look at mind bleeding or mind swelling from the antibodies, which we do not have, that regardless of how you’re taking the drug, you at all times can have 30 or extra proportion of sufferers with that very harmful unintended effects of a drug of an antibody, which we do not have.

However in our case, the adversarial occasion of dizziness is a manageable one as a result of it simply relied on the titration schedule, and that may be versatile, modified. And that is what we now will, in fact, do sooner or later. In order that’s the reply to your query. And likewise, evidently that we’re additionally acknowledging that, and we have heard that from physicians that the dizziness signal once more, not all sufferers had that. We additionally should put this in perspective, that it is a signal that reveals penetration within the mind and reveals that some factor’s taking place within the mind.

Additionally, one final level I would prefer to make that this dizziness lasted actually comparatively quick for these affected person who had it was generally between seven to 11 days within the common. So it is a very — and a gentle type of dizziness. So it is an easy to handle scenario, but it surely reveals up on this trial as a result of once more, we compelled sufferers to go to those excessive doses in a short time, and we discovered the lesson that we are able to keep away from that.

Soumit Roy

That’s actually useful colour. So final query is, when ought to we anticipate the open label 96 week knowledge? Is it CTAD or extra in the direction of the top of the 12 months? And may we anticipate after that knowledge, you’ll strategy the FDA with all the packet submitted to European Authority plus this open degree? Or when you can present any particulars there?

Christopher Missling

Sure, so allow us to first put collectively, knowledge collectively. However as soon as we’ve it, we’ll make the choice. However all of your recommendations might be a sound suggestions.

Soumit Roy

Thanks, and congratulations once more on the progress.

Christopher Missling

Thanks. Admire it.

Clint Tomlinson

That is all of the questions for now, Dr. Missling.

Christopher Missling

Thanks. So in closing, we proceed to concentrate on execution and business readiness as we advance our therapeutic pipeline to probably enhance sufferers’ lives dwelling with these devastating situations. Thanks very a lot.

Clint Tomlinson

Thanks, women and gents. This concludes immediately’s convention name. We admire your participation, and now you can disconnect.