Q2 2023 Anavex Life Sciences Corp Earnings Call

During this 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.

The call will be available for replay on <unk> website at Www Dot <unk> Dot com.

With us today, Dr. Christopher <unk>, President and Chief Executive Officer, and Sandra Burnish 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 a number of risks and uncertainties.

We encourage you to review the Companys filings with the SEC.

This includes without limitation, the Companys forms 10-K, and 10-Q, which identify specific factors that may cause actual events.

Our results to differ materially from those described in these forward looking statements.

These factors may 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 and ability to obtain future capital and maintenance of intellectual property rights and with that I would like to turn the call over to Dr. <unk>.

Thank you Clint 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.

Recent positive clinical study resolves.

And FDA approvals through the accelerated approval pathway.

Pardon me.

We ultimately cause community, especially for patients families and caregivers, who fight every day against this devastating disease.

We look forward to presenting including incentive genre once available the complete data set of the face to be slightly outside these trial of unabated to seven three black comedy a convenient once daily oral small molecule activator of the upstream Sigma one receptor involved.

In historic neural cell homeostasis, and promoting neuroplasticity, which might be at the forefront of patient centric next generation biomarker guided precision medicine outsmart disease treatments.

With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for accelerated approval pathway for.

Or on a X 273 in parallel we plan to proceed with the initiation of a confirmatory ultimate disease study.

We also look forward to making meaningful advances in our neurodevelopmental and other neuro degenerative precision medicine portfolio. This year.

In February we announced completion of enrollment and the excellent phase II <unk> III study.

Our S three for the treatment of patriotic.

<unk> with Ret syndrome, we expect to announce top line results from this potentially pivotal.

Clinical trial in the second half of 2023.

At the end of March reported the preliminary data off the 48 week open label extension Parkinson's disease dementia clinical trial.

The open label study demonstrated the laundry total beneficial effect of <unk> 273 on their pre specified primary and secondary objectives as well as on the planned primary and key secondary endpoints. It is encouraging that the patient's clinical symptoms consistently improved longitudinally.

Over time during the extension phase under active in the next 273 treatment.

This data suggests that <unk> has the potential to slow and potentially reverse the life altering symptoms of Parkinson's disease, and urgent unmet global need.

Following on these promising results, we intend to use the same endpoints in a forthcoming pivotal study of anorexia cemetery and Parkinson's disease.

Further pipeline expansion of the analytics platform using gene Biomarkers of response applying precision medicine for neurological disorders is expected, including planned initiation of a out of exclusivity III imaging focus parking study.

Which is sponsored by the Michael J Fox Foundation.

The planned initiation of a potentially pivotal <unk> three phase III <unk> clinical trial in fragile X syndrome.

Our planned initiation of our analytics pre 71 phase II clinical trial in schizophrenia.

Our planned initiation of a potentially pivotal <unk> three phase two phase three clinical trial for the treatment of a new rare disease indication.

And several clinical publications involving analytics 2003, and 371 in the Ret syndrome burden of in this study.

In conjunction with these planned developments, we continue to expand and strengthen our team to support our objectives.

Including adding a former FDA statistical team leader as head of the bio statistics as well as other industry professionals to manage and support our studies. Finally, we are pleased with the recent expansion of the patent portfolio for <unk> entry into the indication of hypertension hypertension or high blood pressure.

Affects nearly half of adults in the United States.

Especially within our aging society. This new patent will add to our already robust patent portfolio relating to annex 273, and further demonstrates our strong overall commitment to protecting a full range of commercial opportunities of our product portfolio.

And now I would like to direct the call to Sandra Burnish prints.

Principal financial officer part of X for a brief financial summary of the recently reported quarter.

Thank you Christopher good morning to everyone.

I am pleased to share with you today, our second quarter financial results.

During our most recent quarter general and administrative expenses remained consistent year over year at $2 9 million.

Our research and development expenses for the quarter were $11 3 million as compared to $8 6 million for the comparable quarter of fiscal 2022.

The increase in research and development was primarily a result of expanding our team as well as increase in card manufacturing activities and development for future clinical and potential market supply.

Overall, we reported a net loss of $13 1 million, which is <unk> 17 per share inclusive of $4 8 million and noncash items.

Our cash position on March 31 was $153 5 million.

During the quarter, we utilized cash and cash equivalents of $8 5 million to fund our operations.

These current cash utilization rates, we believe we have sufficient cash runway to fund operations and clinical programs beyond the next four years consistent with guidance that we provided in previous quarters.

Thank you and now back to Christopher.

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

Okay.

Thank you Christopher.

We can now begin the Q&A a session. If you have a question. Please raise your hand or enter it into the Q&A box.

Our first question is coming from Sumit Roy at Jones Research.

You can go ahead Schmidt.

Hi, everyone. Good morning, and congrats on all the progress.

If you can give us a little idea on what kind of details on the data that's on the ALS Amazon coming up this quarter like the biomarker details our how much of the maturity of the data.

Data set yourselves.

Yep.

So we are in the process of finalizing.

To receive all the blood Biomarkers, which were measured at the trial.

And once they've been all collected they will be analyzed and put into the.

Into the paper.

You also have the possibility to now because of a new.

New data on a biomarker, which is a surrogate biomarker of the pathology.

To advance the program faster than we thought into oxalate approval.

Since that has been also the case for two previous approvals.

Approvals in the ultimate field and it is very encouraging for us to see that.

So youre going to show the amyloid some.

Status.

Baseline versus.

Six months or 12 months' time point, yes, that's right we have not only a better with Tao with other pathology and biomarkers of inflammation of neuro degeneration and these are all instrumental in describing the pathway.

The pathology and if they do are baking different outcomes with a drug intervention. Then this is a very significant inflammation.

Got it thank you gentlemen.

Thank you so much.

Yes.

At this time I don't see any other analyst questions.

Yep, we see here a couple of other question, we're happy to address.

We'll analytics breakout clinically meaningful honest cog in Adcs ADL scores individually.

Thank her group that would be done paired doses and very clear detail.

The next question is will be a D. NDA is submitted before the confirmatory trial is completed the ounces after discussion with the agency.

For accelerator approval pathway this would be the path, which was also.

Given to the other are proactively approval company approvals. So this could be the case as well otherwise.

Otherwise it would be not accident or approval. If you need a study to begin with so that is the goal of getting the drug approved.

Before completing a confirmatory second trial.

The other questions I see here is.

What are the.

What is the.

The status of partnering discussion flowback Roadblock Compazine, we always said, we try to maximize shareholder value and amongst a value is a assessment or if we can move forward to truck.

Into the market ourselves, which is potentially possible with the.

<unk> space for the U S or for other regions that needs to be assessed.

And for large indications like like ultimate Parkinson that could be.

More challenging or put it this way could be faster, reaching our cash flow levels with a partner. So that's why we always said, we would very likely partner these larger indications to reach higher cash flow and hence create more shareholder value for our shareholders.

Of the company.

I think are there any more questions.

So you want in there from Caroline from Baron burden.

Yeah. So the question was did you mention a confirmatory studies needed again, our consumer studies needed after exited approval and so that is the regarding the additional study, but it's not required for accelerated approval for approval of the drug.

For the Optima study.

Okay, I don't see any further questions at this time and.

Christopher Yes. So again, thank you very much and we're looking forward and we're very excited about the company's potential.

As well as to build on the biomarker driven precision medicine studies with significant unmet medical need and are addressing and on the under treated economic burden and we're looking forward to the upcoming data readout in the ultimate disease study and the patriotic.

Ret syndrome study. Thank you very much looking forward.

Thank you ladies and gentlemen, this concludes today's conference and we appreciate you participating you may now disconnect.