Anavex Life Sciences Q3 2023 Earnings Call Transcript

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August 8, 2023

There are 4 speakers on the call.

Operator

Good morning, and welcome to the Anavex Life Sciences Fiscal 2023 Third Quarter Conference Call. My name is Clint Tomlinson, and I will 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 During the session, if you would like to ask a question, please use the Q and A box or raise your hand. Please note this conference is being recorded.

Operator

The call will be available for replay on Anavex's website at www.anavex.com. With us today is Doctor. Christopher Missling, President and Chief Executive Officer and Sondra Bonich, 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.

Operator

We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's Forms 10 ks and Q, which identify the specific factors that may cause actual results for events to differ materially from those described in these forward looking statements. These factors 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 Doctor. Missling.

Operator

Thank you, Clint, and good morning, everyone. Thank you for being with us today

Speaker 1

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 for blood clamsine. First on Rett syndrome, in June, we announced the completion of the placebo controlled XLEM Phase twothree clinical trial, RS03 in pediatric patients with Rett syndrome, and we're looking forward to the top line 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 on intellectual and developmental disabilities with relevance to this clinical trial entitled Rett Syndrome Behavioral Questionnaire in Children and Adults with Rett Syndrome, cytokinetic characterization and revised factor structure. In the XLEX clinical trial, the characterized Rett Syndrome Behavior Questionnaire, RSPQ, together with the Clinical Global Impression Improvement Scale, CGI, represents the co primary efficacy endpoints of the trial.

Speaker 1

This psychostimatic study is timely and significant as it provides additional support for the use of the RSVQ in children and adult as well as reference values and revised subscales for its improved use. We have also been We are further encouraged for the results of this upcoming data readout based on recent long term clinical trial results from the U. S. ANAVEX-two seventy three RS-one clinical trial, which we announced end of June. The long term data demonstrated disease modifying effect of Blakarmezine for dull patients with Rett syndrome.

Speaker 1

Results from pharmacometric 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 are best characterized by a combined symptomatic and disease modifying drug effect model, meaning that Blacomizid exhibited both symptomatic and disease modifying effects in the treatment of Rett syndrome in a clinical setting. Continued improvement from the drug as measured with the RSPQ total score was observed from the start of the double blind study to the end of the open label extension for patients continuing on Blacomizine. Additionally, Disease progression, which is defined as the change in Rett syndrome disease severity with time, was also reduced with long term treatment with bactamizine. In Alzheimer's disease, we look forward to presenting, including in a scientific journal once available, The complete data set of the recently completed Phase twothree Alzheimer disease trial of Blacomazin. With newly available preliminary of the ongoing clinical development of Blacomizine in this indication.

Speaker 1

With a goal of providing a much needed treatment We expect to be able to announce this data also within the second half of twenty twenty three. Following on the encouraging results Of our Parkinson's D DIMENSION 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 plaqueminesin 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, the pipeline extensions of the Anavex platform using gene biomarkers of response, Applying precision medicine for neurological disorders is expected, including the planned initiation of clinical trial in fragile X syndrome and a planned initiation of a Phase II clinical trial in ADIVX 371 in schizophrenia. We also are planning an initiation of a potential pivotal the Glacomyside trial Phase twothree for the treatment of a new rare disease indication, which we announce accordingly.

Speaker 1

And we continue to expect clinical publications involving ANAVEX-two seventy three, Placamazine and ANAVEX-three seventy 371. In conjunction with these planned clinical developments, we continue to strive to remain at the forefront of innovation. In June, we announced we entered into a strategic partnership with Paratex Group to leverage artificial intelligence for drug development and healthcare 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 Anavec's innovative small molecule precision medicine drug development platform and Partech's disruptive approach of AI enabled drug development and Healthcare Sales Marketing. This collaboration is intended to drive efficiency, effectiveness and innovation across the value chain with patient centric focused at every step.

Speaker 1

Additionally, we continue to expand and strengthen our patent portfolio for Blartamazene with a new U. S. Patent awarded, expanding ANAVEX patent coverage of certain crystal forms of plaqueminesine compositions, process of preparation and uses thereof. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex for a brief financial summary of the recently reported quarter.

Speaker 2

Thank you, Christopher, and good morning to everyone. I am pleased to share with you today our Q3 financial results. During our most recent quarter, Our general and administrative expenses remained consistent year over year at $3,200,000 Our research and development expenses for the quarter were $10,300,000 as compared to $9,300,000 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 as a sustained increase in drug manufacturing activities And development for future clinical and potential market supply. Overall, we reported a net loss of $11,300,000 which is $0.14 per share, inclusive of $3,900,000 in non cash items.

Speaker 2

Our cash position at June 30 was 154,800,000 During the quarter, we utilized cash and cash equivalents of $7,700,000 to fund operations. At our current cash utilization rate, We believe we have continued to have sufficient cash runway to fund our operations and clinical programs beyond the next 4 years. Thank you. And now I will turn it back over to you, Christopher.

Speaker 1

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 clinical trials as planned. I would now like to turn the call back to Clint for Q and A.

Operator

Thank you. We will now begin the Q and A session. And if you have a question, raise your hand or enter it into the Q and A box. So our first question is coming from Sumit Roy at Jones Research. You can go ahead and speak, Sumit.

Speaker 3

Hi, good morning everyone and congratulations on the solid quarter and all the progress. A question on the AZAMR program. Are the patients continuing on a long term study? And any progress on the confirmatory A study to initiate on?

Speaker 1

Yes, excellent question. So the patient on the extension study Actually, it was given a name. It's called the ATTENTION AD study, and it's going over 96 weeks. We have been heard from KOLs that actually this extension study could be the confirmationary study of the ANAVEX2-seventy three Phase IIbIII study itself. So we want to basically put this in context and see how this will progress accordingly.

Speaker 1

So we might already have started this confirmatory study with that open label study, but it will be determined in discussion with regulatory agencies. But we would, of course, be able to, without a problem, initiate a study if so required at any time.

Speaker 3

I see. Do you have any date in mind when the FDA conversation could happen if this study can translate into a Confirmation study?

Speaker 1

Yes. We are planning to do this once the data is available, which is expected this year. And thereafter, Agency is able to address things with data as well and that's what will happen with data in presence of data.

Speaker 3

Okay. And the biomarker study data, is that could you give us some color on how many patient Results are going to present an expectation because this is not a targeted agent towards the Amazon Cloud. So what should be Street's expectations? And could you refine the timeline? Is it going to be later like in November timeline or Could be earlier in Q3?

Speaker 1

I would say we keep the we want to surprise the market, so we it's the second half of this year And we'll 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 and the majority of them have received blood biomark 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 entire population of the trial.

Speaker 3

That is really helpful. And one last question on the RET program. Clearly, you are heading towards getting the Top line data from the EXCELLENCE study, how are you thinking path forward? Are you thinking about Commercializing yourself or is it going to be a partnership program? If it's going to be by Anavex, the commercialization part, When should we start thinking about hiring the commercial team?

Speaker 1

Yes, excellent question. So with the collaboration with Partex, we already initiated the strategizing on the sales force numbers, the across the globe in all regions of the world from all regions of the world to either co market or to license, Black Camizine for red syndrome already. So we have multiple options open and We try to do the make 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 term sheets on the table. Which will likely happen after the data is out.

Speaker 3

Thanks. Well, thank you again for taking all the questions and congratulations on all the progress. Thank you.

Operator

I don't see any other analyst questions. Doctor. Missing, if there's anything that you want to add here, you're more than welcome to.

Speaker 1

Thank you very much. I think the question from Sumit was very comprehensive. Again, we like to very much Point out that we're looking forward to a very excited second half of this year. We are very excited about the potential, what we built. We expect further publications and of our biomarker driven physician medicine studies, which have all significant unmet need and economic burden, and we remain focused on execution as we prepare for a pivotal year ahead of us, potentially involving Meaningful advances in our neurodevelopmental in neurodegenerative precision medicine portfolio.

Speaker 1

Thank you very much and stay tuned. Looking forward.

Operator

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

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