Q3 2023 Anavex Life Sciences Corp Earnings Call

Good morning, and welcome to the <unk> Life Sciences fiscal 2023 third quarter Conference call. My name is Clint Tomlinson and I'll 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 the session. If you would like to ask a question. Please use the Q&A box or raise your hand.

Please note. 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 Muscling Pres.

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 current information and expectations and involve 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 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 include without limitation risks inherent in the development <unk> commercialization of potential products and <unk>.

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 turn the call over to documents line.

Thank you Glenn and good morning, everyone.

Thank you for being with US today to review, our most recently reported financial results and to provide our quarterly business update.

We are very excited to be entering an important phase of the company with several key data readouts within the remainder of 2023 four black comedy.

First in Ret syndrome in June we announced the completion of the placebo controlled excellent phase II III clinical trial.

<unk> III and patriotic patients with Ret syndrome, and we're looking forward to the topline data of this potentially pivotal clinical trial in the second half of 2023.

On June 12, we announced the publication of a new peer reviewed study in the American Journal, an intellectual and developmental disabilities with relevance to this clinical trial entitled <unk> syndrome behaviour questionnaire in children and adults with Ret syndrome.

Somatic characterization and revised factor structure.

And the excellent clinical trial characterized vets and there'll be able questionnaire RFP queue together with the clinical global impression improvements scale CGI represents the co primary efficacy endpoints of the trial.

This second cosmetic studies timely insignificant as it provides additional support for the use of <unk> in children and adults as well as reference values and revised subscale sports improved use.

We are also be further encourage for the results of this upcoming data readout based on recent long term clinical trial results from the U S. On a X 273 Rs zero, one clinical trial.

Which we announced end of June .

The long term data demonstrated disease modifying effect of <unk> for adult patients with <unk> syndrome.

Results from pharmacokinetic modeling of the full clinical data from baseline of the double blind study to the end of the open label extension study indicated that the data best characterized by a combined <unk>.

Symptomatic and disease modifying drug effect model mean.

Meaning that <unk> exhibited both symptomatic and disease modifying effects in the treatment of ret syndrome in a clinical setting.

Continued improvement from the drug as measured with the <unk>.

<unk> total score was observed from the start of the double blind study to the end of the open label extension for patients continuing on that comes in.

Additionally, disease progression, which is defined as the change in Ret syndrome disease severity was time was also reduced with long term treatment with cognizant.

In ultimate disease, we look forward to presenting including in our scientific journal once available.

Complete dataset of the recently completed phase II <unk> III ultimate disease trial of <unk>.

With newly available preliminary efficacy results of surrogate biomarkers.

We tend to initiate discussions with regulatory agencies in the context of the ongoing development of <unk> in this indication.

With the goal of providing a much needed treatment for the millions of patients living with ultimate disease, and a convenient once daily oral treatment.

We expect to be able to announce this data also within the second half of 2023.

Following on the encouraging results of our patterns in the dementia clinical trial, including the results of the 48 week open label extension of this trial.

Which we announced at the end of March we tend to use the same endpoints in a forthcoming pivotal study of <unk> in Parkinson's disease.

Which is currently in the planning stages, and we look forward to announcing the significant milestones of this clinical trial initiation as they are executed.

Further.

Pipeline expansions of the analytics platform using gene Biomarkers of response applying precision medicines for neurological disorders is expected, including the planned initiation of cognizant imaging focus parkinsonism pivotal trial sponsored by the Michael Fox Foundation.

The planned initiation of a potentially pivotal Latam is in phase II <unk> III.

Trout in fragile X syndrome.

And a planned initiation of a phase two clinical trial.

<unk> 71 in sheets of framework.

We also are planning and initiation of a potential pivotal <unk> trial phase to slide three for the treatment of a new rare disease indication, which we announce accordingly.

And we continue to expect clinical publications involving <unk>, three <unk> and $3 71.

In conjunction with these planned clinical development, we continue to strive to remain at the forefront of innovation.

In June we announced we entered into a strategic partnership with <unk> group to leverage artificial intelligence for drug development and health care sales marketing potentially involving a digital healthcare sales marketing pharma platform.

With the overall ambition to reshape the future of the Biopharma business model.

By combining analytics innovative small molecule precision medicine drug development platform and potash disruptive approach of AI enabled drug development and health care sales marketing. This collaboration is intended to drive efficiency effectiveness and innovation across the value chain with pace.

<unk> centric focused at every step.

Additionally, we continued to expand and strengthen our patent portfolio for block Amazon with a new U S patent awarded expanding.

On the VIX patent coverage of certain crystal forms of glaucoma gene compositions process of preparation and users they're off.

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 morning, everyone.

Im pleased to share with you today, our third quarter financial results.

During our most recent quarter, our general and administrative expenses remained consistent year over year at $3 2 million.

Our research and development expenses for the quarter were $10 3 million as compared to $9 $3 million in the comparable quarter of fiscal 2022.

The increase in research and development costs year over year was primarily a result of our expanded team as well on a sustained increase in card manufacturing activities and development for future clinical and potential market supply.

Overall, we reported a net loss of $11 3 million, which is 14 <unk> per share increase of $3 9 million in noncash items.

Our cash position at June 30th was $154 8 million.

During the quarter, we utilized cash and cash equivalents of $7 7 million to fund operations.

At our current cash utilization rate. We believe we have continue to have sufficient cash runway to fund our operations and clinical programs beyond the next four years. Thank you and now I'll turn it back over to you Chris.

Thank you Sandra and this is a really exciting time for the company and we remain on track to for Readouts of completed clinical trials and initiation of additional biomarker driven precision medicine to enter trials as planned I would now like to turn the call back to <unk> for Q&A.

Thank you.

We will now begin the Q&A session. If you have a question raise your hand or entered into the Q&A box.

So our first question is coming from Sumit Roy Jones research.

You can go ahead and speak soon.

Hi, good morning, everyone and congratulations on the solid quarter on all the progress.

A question on the.

Alabama program.

Are the patients are continuing on a long term study.

And to any progress on the confirmatory.

Ah study.

To initiate on.

Yeah excellent question. So the patient on the extension study actually has given was given the name it's called the attention of a D study and its going over 96 weeks, we have been heard from Kols that actually this extension study.

Would be the.

Conformational study.

After <unk> is in three phase III <unk> study itself.

So we want to basically.

Put this in context and see how this will progress accordingly, so we might already have started this confirmatory study with that open label study, but it will be determined.

In discussion with regulatory agencies that we would of course be able to without a problem initiate a study if so required at anytime.

I see.

Do you have any.

Date in mind, when the FDA conversation could happen if the study can translate into a conformation study. Yes. We are planning to do this once the data is available which is expected this year and thereafter.

Nancy.

<unk> is able to address things with data as well and Thats, what will happen with data and presence of data.

Okay.

And the biomarker.

Study data is that could you give us some color on how many patients.

The result is going to present.

An expectation because this is not a targeted agent towards them about flat, so what should be the street's expectations and.

Could you refined the timeline as it is going to be later like in November timeline could be.

Earlier in third quarter.

Oh, I would say if we keep the.

We want to surprise to the market. So we it's the second half of this year and we.

Be able to then provide the data once it's available.

And regarding the color so it will be the entire.

Participants of the trial.

The majority of them have received a blue.

That biomarker assessment before and after as well as MRI assessment.

And a smaller sample size has also received CSF samples.

So this is right now the the entire population of the trial.

Well that is really helpful and one last question on the Ret program clearly you are heading towards.

Getting them.

Topline data from the excellent study.

How are you thinking paths forward are you thinking about commercializing yourself or is gonna be partnership program.

If it's going to be.

<unk> the commercialization part.

When should we start thinking about hiring.

The commercial team.

Yeah excellent question, so with the collaboration with politics, we already initiated the strategizing on the sales for numbers.

The expansion of marketing strategies, but also we received unsolicited interest from.

Across the globe in all regions of the world from all regions of the world to either co markets or to license.

Cummins in for Ret syndrome already so we have multiple options open and we tried to do to make a decision based on shareholder value. So what will create more shareholder value Accordingly, and we will base that decision on based on that information. Once we are able to get <unk> on.

The table.

Likely happened after the data is out.

Thanks.

Thank you again for taking all the questions and congratulations on all the progress.

Thank you.

I don't see any other analyst questions, Doug missing if there's anything that you are.

Want to add here, you're more than welcome to bank.

Thank you very much I think the question from <unk> Schmidt was very calm comprehensive again, we like to very much pointed out that we're looking forward. We're very excited second half of this year. We are very excited about the potential what we build we are expecting further publications.

And of our biomarker, driven and precision medicine studies, which have all significant unmet need and economic burden and we remain focused on execution as we prepare for pivotal year ahead of us potentially involving meaningful advances in our neurodevelopmental in neuro degenerative precision medicine portfolio portfolio.

So thank you very much and stay tuned looking forward.

Thank you Doctor missing, ladies and gentlemen that will conclude our call for today. We appreciate your participation and you may now disconnect.

Sure.