Q4 2023 Anavex Life Sciences Corp Earnings Call

Speaker 1: 3 fourth quarter conference.

Speaker 1: 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 session. During this session, if you would like to ask a question, please use the Q&A box or raise your hand.

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 this session. If you would like to ask a question. Please use the Q&A box or raise your hand.

Speaker 1: Please note that this conference is being recorded and the call will be available for replay on Anavex's website at www.anavex.com.

Please note that this conference is being recorded and the call will be available for replay on <unk> website at Www Dot <unk> Dot com.

Speaker 1: With us today is Dr. Christopher Misling, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer.

With us today is Dr. Christopher <unk>, President and Chief Executive Officer, and Sandra <unk> Principal financial Officer.

Speaker 1: 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 the current information and expectations and involve a number of risks and uncertainties.

Before we begin 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 company's filings with the SEC.

Speaker 1: We encourage you to review the company's filings with the SEC.

Speaker 1: This includes, without limitation, the company's forms 10-K and 10-Q, which identify the specific factors that may cause actuary results or events to differ material from those described in these forward-looking statements.

This includes without limitation, the company's 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.

Speaker 1: 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'd like to turn the call over to Dr. Misling.

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. <unk>.

Thank you Ken and good morning, everyone.

Speaker 2: Thank you for being with us today to review our most recently reported financial results and to give our quarterly business update.

Thank you for being with US today to review, our most recently reported financial results.

And to give our quarterly business update.

We are very excited to be entering a new phase of the company's history.

Speaker 2: We are very excited to be entering a new phase of the company's history.

Speaker 2: For the first time, we initiated the process of submitting a marketing authorization application to the European Medicines Agency, EMA.

For the first time, we initiated the process of submitting a marketing authorization application to.

To the European Medicines Agency EMA.

Speaker 2: for glaucamazine related to the treatment of Alzheimer's disease.

<unk> related to the treatment of ultimate disease.

Speaker 2: Relatedly, we are starting to explore possible commercial activities and examining innovative strategies to effectively engage patients, providers, and payers.

Relatedly, we are starting to explore possible commercial activities and examining innovative strategies to effectively engage patients providers and payers.

Speaker 2: There's a high demand for Alzheimer's disease patients and families for easy access and scalable treatment options.

There is a high demand for ultimately these patients and families.

Easy access and scalable treatment options.

We are striving to work towards presenting a drug that will potentially improve patients' lives with our precision medicine oral block common theme, which is intended to reduce the need for complex procedure for the treatment of people with Alzheimer disease.

Speaker 2: we are striving to work towards presenting a drug that will potentially improve patients' lives with our precision medicine oral blockamazine, which is intended to reduce the need for complex procedures for the treatment of people with Alzheimer's disease.

Speaker 2: According to the European Brain Council, there are an estimated 7 million people in Europe with Alzheimer's disease, a number expected to double by 2030.

According to the European Brain Council. There are an estimated 7 million people in euro with ultimate disease, a number expected to double by 2030.

Full data from the Black comes in Phase <unk> III randomized clinical trial and ultimately these will be published in an upcoming peer reviewed journal.

Speaker 2: Full data from the Black-Carmesan Phase 2b Slash 3 randomized clinical trial in Alzheimer's disease will be published in an upcoming peer-reviewed journal.

Speaker 2: Also, the respective open-label extension 96-week trial, ATTENTION-AD, is ongoing.

Also the respective open label extension 96 week trial attention <unk> is ongoing.

Speaker 2: Regarding Rett syndrome, we are on track for top-line data of potentially pivotal RNAVX273 RS003 phase 2 slash 3, excellence pediatric clinical trial.

Regarding ret syndrome, we are on track for topline data of potentially pivotal under exclusivity III <unk> III phase II <unk> III excellence patriotic clinical trial.

Speaker 2: Regarding the Parkinson's disease program, we are in preparation to initiate the ANAVAX-273 imaging focus trial and the ANAVAX-273 phase 2b slash 3 six-month trial.

Regarding the Parkinson's disease program, we in preparation to initiate the <unk> 273 imaging focused trial and the <unk> 273 phase two these last three six months trial.

Related to schizophrenia, we and preparation to initiate the phase II clinical trial with <unk> 371, our second clinical stage small molecule.

Speaker 2: Related to schizophrenia, we are in preparation to initiate the phase 2 clinical trial with Adavex 371, our second clinical stage small molecule.

Speaker 2: Respect to Fredalex, we are in preparation to initiate a financially pivotal ANUVEX 273 Phase 2-3 clinical trial.

Respective fragile X we are in preparation to initiate a financially pivotal <unk> 273 phase II <unk> III clinical trial.

And related to our new rare disease, we and preparation to initiate a potentially pivotal on <unk> III phase III last week clinical trial.

Speaker 2: And related to a new rare disease, we are in preparation to initiate a potentially pivotal on avex273 phase 2 slash 3 clinical trial.

Speaker 2: We are also expecting further peer-reviewed clinical publications involving ANAVAX 273 and ANAVAX 371.

We are also expecting further peer reviewed clinical publications involving annex 273, and <unk> III 71.

Speaker 2: In October , we announced a new peer-reviewed publication in the journal Neurobiology of Aging, titled Early Treatment with an M1 and Sigma-1 Receptor.

In October we announced a new peer reviewed publication in the journal Neurobiologically of aging titled early treatment with an <unk> and Sigma one receptor agonist prevents cognitive decline net transgenic rat model displaying ultimate like amyloid pathology.

Speaker 2: Prevents cognitive decline in the transgenic rat model, displaying Alzheimer-like amyloid pathology.

Speaker 2: Featuring the already available small molecule Anavex 371.

Featuring the orally available small molecule on <unk> III 71.

Speaker 2: This preclinical study describes the potential disease-modifying properties of ANOVAX 371 on Alzheimer's disease pathology as a possible drug candidate for one's daily oral preventative strategy for Alzheimer's disease.

This preclinical study describes the potential disease modifying properties of <unk> hundred 71 on ultimate disease pathology.

Possible drug candidate for once daily oral preventative strategy for Alzheimers disease.

And lastly, this months.

Speaker 2: And lastly, this month, we announced the expansion and strengthening of our patent portfolio with the United States Patent and Trademark Office, USPTO, granting US patent number 11813242, entitled A2-73, as a therapeutic for insomnia, anxiety, and agitation.

Announced the expansion and strengthening of our patent portfolio with the United States patent and trademark office U S. PTO granting U S patent number 11, 813% to four two entitled eight tools Slash Dash seven three as a therapeutic for insomnia anxiety.

And agitation.

Speaker 2: This patent expands Anavex's existing patent coverage of Blacamezine including U.S. patent number 11337953 to cover Anavex's leading drug candidate, Blacamezine, Anavex-141 and Anavex-9144 for treating insomnia, anxiety, or agitation.

This patent expense on the next existing patent coverage of <unk>, including U S. Patent number 11 with three 795 three to cover <unk>, leading drug candidates like cognizant.

And the next 141, and <unk> 90, 144 for treating in Sanya anxiety or agitation.

Speaker 2: This granted U.S. patent is another important milestone in protecting the commercial potential of black carmesine and other lead compounds.

This granted U S patent is another important milestone and protecting the commercial potential of black cognizant and analytics other lead compounds with.

Speaker 2: with a practical value of delivering holistic care for patients with Alzheimer's disease, dementia, or Parkinson's disease.

With the practical value of delivering holistic care for patients with ultimate disease dementia or Parkinson's disease.

And now Paul.

Speaker 2: And now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Aravex, for a financial summary of the recently reported quarter.

I would like to direct the call to Sandra Burnish principal financial officer of <unk>.

For a financial summary of the recently reported quarter.

Speaker 3: Thank you, Christopher, and good morning, everyone. I am pleased to share with you today our fourth quarter financial results.

Thank you Christopher and good morning, everyone.

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

Speaker 3: Our cash position on September 30th was $151 million.

Our cash position on September 30th $151 million.

Speaker 3: During the quarter, we utilized cash and cash equivalents of $5.8 million to fund our operations.

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

Speaker 3: At our current cash utilization rate, we believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years.

At our current cash utilization rate. We believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years.

During our most recent quarter general and administrative expenses were $2 6 million compared to $3 2 million last quarter.

Speaker 3: During our most recent quarter, general and administrative expenses were $2.6 million compared to $3.2 million last quarter.

Our research and development expenses for the quarter were $10 million as compared to $10 3 million for the last quarter.

Speaker 3: Our research and development expenses for the quarter were 10 million as compared to 10.3 million for the last quarter.

Speaker 3: And lastly, we reported a net loss of $10.1 million for the quarter, or $0.12 per share.

And lastly, we reported a net loss of $10 1 million for the quarter were 12 <unk> per share.

Speaker 3: Overall, and in summary, we plan to continue to be fiscally responsible, and we believe we continue to have sufficient cash runway to fund operations and clinical programs beyond the next four years. Thank you.

Overall and in summary, we plan to continue to be fiscally responsible and we believe we continue to have sufficient cash runway to fund operations and our clinical programs beyond the next four years.

Thank you and now back to your question Brent.

Speaker 2: Thank you, Sandra. Again, this is an exciting time for the company, and we're very excited to be entering a new phase of the company's history with our biomarker-driven precision medicine program.

Thank you Sandra again this is an exciting time for the company and we're very excited to be entering a new phase of the company's history without biomarker driven precision medicine programs.

Speaker 2: I would now like to turn the call back to Clint for Q&A.

I would now like to turn the call back to plan for Q&A.

Speaker 1: Thank you, Christopher. We'll now begin the Q&A session. If you have a question, please raise your hand or enter it into the Q&A box. And our first question is coming from Schmidt-Roy at Jones Research Center.

Thank you Christopher will now begin the Q&A session. If you'd have a question. Please raise your hand or entered into the Q&A box and our first question is.

Is coming from Sumit Roy.

Jones research.

Speaker 4: Hi, good morning, everyone, and congratulations on all the progress.

Hi, good morning, everyone.

And congratulations on all the progress.

Speaker 4: First question on the MMA application. So if you can give us a little background on the discussions you've had with the European authority and how much data they have seen that prompted the application for full approval rather than a conditional approval.

First question on the EMEA application. So if you can give us a little bit.

Background on the discussions here.

European authority in how much data they have seen.

That prompted the.

Application for full approval rather than a conditional approval.

Speaker 2: Yeah, thank you, Sumit. We have met the European Agency several times in meetings, and we have shared the data, which is not yet published, which is the published data of the planned published communication of the full data of the Alzheimer phase 2b slash 3 study.

Yeah. Thank you submit we have met the European agency several times in our meetings and we have shared the data which is not yet published which is the published data of the plan published.

Communication of the full data off the optima phase to be stretched III study.

Speaker 2: And we were, from this meeting, recommended to proceed with this application, full approval application. And that's what we proceeded with last week accordingly.

And we were from this meeting recommended to proceed with his application full approval application.

And that's why we proceeded with.

Last week accordingly.

Speaker 4: I see. And what are the plans for the U.S. approval? Do you, is this going to prompt a FDA conversation if you have any meeting schedules or you think you would go ahead with a phase, post-phase 3 trial or?

Hi.

Or what are the plans for the U S approval do you is this got a prompt our FDA conversation. If you have any meeting scheduled are you poke you would go ahead with the phase <unk> phase III trial.

Two trials.

Speaker 2: So, we have the ongoing Attention AD study ongoing, and that's part of the package.

So we have the ongoing attention a D study ongoing and that's part of the package.

Speaker 2: of the application with the Phase IIb stress-free study.

Of the application.

With a face to be stress free study.

Speaker 2: We knew that the timing of the European application takes longer, so we proceeded with that first.

We knew that the timing of the European application takes longer.

So we proceeded with that first that does not mean that we will proceed with other international application as well, but the rupee in decision to start the dialogue with the European Agency was also based on the fact that we had a majority portion of the patients in that region.

Speaker 2: that does not mean that we will proceed with other international applications as well. But the European decision to start the dialogue with the European agency was also based on the fact that we had a majority portion of the patients in that region. So it would be a respectful decision to approach the European agency first.

So it would be a respectful of decision to approach the European Asia first.

Speaker 4: Thank you. And one last question on the REDD program.

And one last question on the Red.

Program.

Speaker 4: Could you give us a little color? When are you still expecting the data? Is it going to be before the year end 23? And is there any delay? Or is it an expected safety window that you have follow-up that you are doing, which is why pushing the data back?

You didn't give us a little color.

When are you still expecting the day, David Columbia before the year end 2003 and.

Eric will delay or is it an expected.

Safety window that you have follow up that you have to you are doing which is while pushing the data.

Speaker 2: Yeah, after the last 12-week readout, there was an additional safety follow-up. And that's basically why the timing is maybe a little bit different from expectations. But we are on track to release this data once we have it.

Yeah after the last.

12 week readout, there was an additional safety follow up and that's basically why the timing may be a little bit different from expectations.

But we are in <unk>.

On track to release this data once we have it.

Speaker 4: Great. Thank you so much and congratulations again on all the progress.

Oh, great. Thank you so much and congratulations again on all the progress.

Thank you.

Speaker 5: Thank you, Shima. The next question will come from Tom Bishop at Bishop Research. Go ahead, Tom. You're.

Thank you Shimon.

The next question will come from Tom Bishop.

At <unk> research.

Go ahead Tom.

Ah you're muted I believe Tom.

Can you hear me now.

Oh, yes, there's a little echo, but we can hear you.

Okay.

Oh boy.

Sure.

Can you.

Will we get insomnia data.

Speaker 2: Go ahead, insomnia. So part of the trial's outcome was sleep measures.

You'll have insomnia, so part of the trials outcome was.

Sleep measures.

Speaker 2: of the phase 2b stretch 3 asthma study and we will also have

Of the face to be stressed III Optima study.

And we will also have.

Speaker 2: analysis of this data and we will also make sure that this data will be made public.

The analysis of this data.

And we will also make sure that this data will be.

<unk> made public.

Speaker 2: We had noticed in our Parkinson's disease dementia study an improvement for those patients who had insomnia.

We have noticed in our Parkinson's disease dementia study a improvement for those patients who had insomnia to improve these.

Speaker 6: to improve this indicator.

Indication.

Speaker 2: And we have seen similarly in the Alzheimer's study an improvement of that endpoint as well.

And we have seen similarly in the ultimate study and improvement.

Of that endpoint as well.

Speaker 2: And that also was the basis for the patent and the patent application and ultimately the granting of the patents.

And that also was the basis for the patents and patent application and ultimately the granting of the patents. So the answer is yes. This data eventually will be also made public the beneficial effect of the drug on the sleep paradigm.

Speaker 2: So the answer is yes. This data eventually will be also made public. The beneficial effect of the drug on the sleep paradigm.

Speaker 2: But in the final data? It might be done in several different slices of papers, because papers have a limited number of data points and number of words you can include. So the first paper will be the full data of the main items at the end point. And then additional end points might be separately published.

But in the final data.

It might be.

Done in several.

Ah different slices of papers because papers have a limited <unk>.

A number of.

Data points and number of words you can include so the first paper will be the full data.

The main item.

Employee and.

And then additional.

Endpoints might be separately published.

Hum.

What about Australia.

What about Australia.

Speaker 7: What about Australia? Yes, you know...

Yes.

Approval.

So the again as I mentioned before the most time consuming lengthy because it's a very structured process. This deadline is the European application and that's why we went there first.

Speaker 2: So again, as I mentioned before, the most time-consuming, lengthy, because it's a very structured process, this deadline, is the European application. And that's why we went there first, and also because.

And also because.

That patients were mostly or partially in Europe is for that reason we started the process there.

Speaker 2: that patients were mostly or partially in Europe is for that reason we started the process there. The main reason was really that the process for application takes the longest in Europe . So it's the first we started with.

The main reason was really that the process for application takes the longest in Europe. So it's the first we started with.

Speaker 2: and the international other applications will subsequently proceed.

And the international other applications will subsequently proceed.

Okay, the Parkinson's data.

Speaker 7: OK, the Parkinson's data has been in the wings for a long time. What's the delay? What's possible?

It has been in the wings for a long time, what's the delay.

What.

Parkinson data please.

The Parkinson's your next trial the initiation of the trial, yes. So we had several very productive.

Speaker 2: The Parkinson's, the next trial. The initiation of the trial? Yes. So we had several very productive interactions with KOLs, and we were able to fine-tune the protocol to max.

Interaction with Kols, and we were able to clear my assurance protocol between Max lies.

Speaker 5: this protocol to make it really crystal clear and easy to adhere to, but also make it meaningful for future application. And that's why we ended up doing it so, so, you know, properly. And you will get the news eventually that when we have the first patients dosed. So we proceed with that indication. Thank you very much. Thank you.

And is this protocol to make it.

Crystal clear.

And easy to adhere to but also make it meaningful for future application and that's why we ended up doing it.

So so properly and you will get the news eventually that when we have the first patients dosed. So we proceed with that indication.

Oh, the enrolment of the 96 trial.

The status.

So the journey with my priority list.

Speaker 2: The majority of the patients from the 96th ATTENTION-AD trials

The majority of the patients from the 96 essentially deep trial.

Yes.

We are derived from the asthma phase two <unk> study.

Speaker 2: we're derived from the Alzheimer phase 2b slash 3 study. And they all came from the Alzheimer phase 2b slash 3 study. That's the correct way to put it. And we had extremely high rollover from the double-blind placebo controlled trial into the open label attention ID study. I think it was over 90%.

And David day, they all.

Came from the Ultima Phase II <unk> study, that's a correct way.

Way to put it and we had extremely high rollover from the double blind placebo controlled trial into the open label attention. These study.

It was over 90%.

Speaker 6: And we have a large number of patients on this study.

And we have a large number of patients on this study.

Speaker 6: We even have the first patients who finish that study going over and requesting an extension of this extension by another year.

We even have a the first patients who finished that study going over and requesting an extension of this extension by another year.

Speaker 2: So it became now a 144-week study for some patients. And after, we also have patients which requested to be given the drug continuously, and we provided them the drug on compassionate use.

So it became now a 144 week study for some patients and the after we also have patients with requested to be given the drug continuously.

And and we've provided them the drug on compassionate use.

Speaker 2: So there's a high request for patients to stay on the study drug.

So there's a high requests for patients to stay on the study drug.

Thank you. Thank you.

Speaker 8: Thank you. Thank you. Thank you. Thank you. Sorry for the echo. The echo.

Sorry for the aircraft.

No problem.

That's okay topside plate I believe that's the end of the.

Speaker 1: It's okay. So, I believe that's the end of the.

Because we have no further questions at this time.

Speaker 1: calls. We have no further questions at this time.

Mr.

Thank you. So again this is an exciting time for the company and we're very excited to be entering a new phase of the company's history with our biomarker driven precision medicine programs in addressing significant unmet medical needs and economic burden.

Speaker 6: Well, thank you. So again, this is an exciting time for the company. And we're very excited to be entering a new phase of the company's history with our biomarker-driven precision medicine programs and addressing significant unmet medical needs and economic burden. We remain very focused on execution as we prepare for the year ahead of us. Thank you very much.

We remain very focused on execution as we prepare for the year ahead of us. Thank you very much.

Speaker 1: Thank you, ladies and gentlemen, this concludes today's conference call and we appreciate you participating. You may now disconnect.

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

Okay.

Okay.