Q1 2023 Anavex Life Sciences Corp Earnings Call

Speaker 1: about the data and plan to submit the data for publication in a peer-reviewed medical journal in the near term. As a reminder, Alzheimer's disease represents a growing burden to healthcare systems and societies worldwide. This disease is often multifactorial and complex in nature.

Speaker 2: We believe that our precision medicine platform, the novel central nervous system mechanism, improved the chance of clinical success. We are pleased by the results of the placebo-controlled phase 2 B-slash-3 Alzheimer disease trial, which data suggests that anavextrism-3, Placamezine, an orally available small molecule activator of the upstream sigma-1 receptor, is pivotal to restoring neural cell homeostasis and promoting new plasticity.

Speaker 3: and might be at the forefront of biomarker-guided, pathway-based, targeted precision medicine drug development.

Speaker 4: We look forward to presenting the complete data set of the study, as well as the other long-term study data of the other programs, including Parkinson's disease, dementia and red syndrome. With a deep portfolio of promising therapies, we believe that UNEVAX remains well positioned to address the urns needs of patients.

Speaker 5: affected by neurodegenerative and neurodevelopmental diseases. Going back to the REDD syndrome program, we announced recently on February 2nd last week the completion of enrollment of the randomized placebo-controlled X-lens phase 2-3 study for the treatment of patriotic patients with REDD syndrome.

Speaker 6: We expect to announce topline results from the study in the second half of this year.

Speaker 7: In Parkinson's dementia, we are planning to announce data from the 48-week open label extension of the previously successfully completed phase 2 study. In other indications, recent communication with the FDA confirms our strategy to advance NFX273 for the treatment of fragile leg syndrome.

Speaker 8: We plan to initiate this trial soon and will share more details about this clinical program in the near term as it becomes available. Further, pipeline expansion of the UNAVEX platform using gene biomarkers of response applying precision medicine of neurological disorders is expected.

Speaker 9: including plant initiation of an Anavexus M3 imaging focus Parkinson's disease clinical study sponsored by the Michael J. Fox Foundation. A plant initiation of a phase 2-slice-free clinical trial for the treatment of a new rare disease indication and the plant initiation of Anavexus 3-71 phase 2 clinical trials for children.

Speaker 10: And last but not least, we expect several clinical publications involving NFX-273 and a Rett Syndrome Burden of Illness Study.

Speaker 11: And now I would like to direct the call to Sander Böhnish.

Speaker 12: Principal Financial Officer of ANERX for a brief financial summary of the recently reported quarter.

Speaker 13: Thank you, Christopher, and good morning to everyone.

Speaker 14: We continue to demonstrate operating fiscally responsibly.

Speaker 15: During our first fiscal quarter, general and administrative expenses were $3.3 million, compared to $3.1 million for the comparable quarter of fiscal 2022.

Speaker 16: Our research and development expenses for the quarter were 12.1 million as compared to 8.7 million for the comparable quarter of fiscal 2022.

Speaker 17: Overall, we reported a net loss of $13 million, or $0.17 per share, inclusive of $5.3 million in non-cash compensation items.

Speaker 18: Our cast position at December 31st, 2022 was 143.6 million.

Speaker 19: During the quarter, we utilized cash and cash equivalents of $5.8 million to fund our operations.

Speaker 20: At our current cash utilization rate, we believe we have sufficient cash runway to fund operations and clinical programs beyond the next four years, consistent with guidance in previous quarters.

Speaker 21: The increase in research and development expenses over the comparable period is primarily related to the expansion of our team and an associated increase in compensation and non-cash charges period over period, as well as costs associated with our Phase 2B slash 3 study, NFX 273 AD 004.

Speaker 22: and the manufacturer of additional clinical trial supply for upcoming pipeline programs.

Speaker 23: Thank you and now back to you, Christopher.

Speaker 24: Thank you, Sandra. This is an exciting time for the company and we remain on track for completion and readout of ongoing clinical trials and initiation of additional biomarker-driven precision medicine clinical trials as planned. I would like now to turn the call back to Clint for Q&A.

Speaker 25: Thank you, Christopher. We will now begin the Q&A session. If you have a question, raise your hand or please put it in the Q&A box. The first question is going to come from Shumet Roy at Jones Research.

Speaker 26: I think you can go ahead, Smith.

Speaker 27: Hi everyone, congratulations on all the progress. Could you give us a little color on what kind of details on the Alzheimer's data we are going to expect? Are we going to see some MRI data or?

Speaker 28: time course of how the

Speaker 29: the reduction in the cognitive benefit decline has occurred or something like that.

Speaker 30: Yeah, so several items will be in the paper, in the publication. Of course, we made sure that the study has a lot of biomarkers and additional measures of endpoints.

Speaker 31: So among them is MRI, which is a very important marker of pathology, which is the most accurate picture of the brain. And it's very well described that the brain atrophy moves in this pathology aggressively.

Speaker 32: So that will be part of the analysis as well as additional biomarkers of pathology like A, beta and tau, as well as the biomarker which are specific to ANAREX, which is the Sigma-1 variant analysis.

which was clearly pre-specified, which you remember we noted that patients with a wild type sigma-1 receptor did much better compared to those who had a variant, but because variant carriers were in the minority

Often that signal overall was not affecting the significance of all patients.

but it was notable that there was a better outcome in patients with wild-type sigma-1 carrier status in previous studies. So we are looking forward to seeing how this plays out in this study as well. But then also we will see the response to the endpoints of the study.

depending on doses as well as over the period of time because we measure every three months the time points within the study. And then you will see additional endpoints which have been included in the study like quality of life.

sleep quality and other behavioral measures which are related to the atemopathology.

Thank you for the data. That was really helpful. Should we expect the data to come out?

first half of this year or are you?

It would be more like second half should be our expectation We actually try to do this as soon as possible because we want to share that also with the agencies in The FDA in Europe , so we are really keen to do that as soon as possible, but at this point in time

It's super mature to give guidance on the timing, but you can be assured we do that as soon as possible.

Thank you so much for taking the questions and congrats on all the progress. Thank you. The next call comes from Yunzong at PTIG. I think you can go ahead, Yunzong.

Hi, good morning. Thank you very much for taking questions. So, Christopher, can you talk about your plan for the regulatory discussion with the FDA on the Alzheimer's indication? Have you started any...

Talk to the FDA. Sorry. A bit of cut off. Sorry, did you ask that again? We had a glitch. Okay, no problem. So I was wondering, your plan for the discussion with the FDA, have you started anything or do you have to wait for additional data to be available before you can start that conversation with the FDA? The Aud buy for quality crowd

That's correct. The FDA engages when you have data and that's exactly where we are. So the data means a complete data set as far as possible. That's why we are so keen to complete that as I just mentioned because that's how you can engage with the FDA as well as with the European EMA Agency.

Okay, and then, as mentioned to the Red Syndrome study, I believe the person who is announcing over a woman had the language that was the FDA's input. You are using the primary end point, so I wanted to confirm that the primary end point is RSPQ and you see similar to the same.

to the one used in the avatar study and so has the FDA agreed that the AUC, the modified RSPQ scale can be an appropriate endpoint for red syndrome study? Yes, we have it described in clinicaltri.gov and it was also never changed in clinicaltri.gov for the excellent study.

It is the RGBQ as primary endpoint and the CGI is key secondary endpoint.

This is the code of the trial.

Is that the same endpoint that was used in the avatar study? Slightly different. So it's actually the measurement over time from beginning to end of trial.

Not AUC, what AUC?

What AUC?

Exactly, yes. Because the study is large enough that it can carry the signal by itself without AUC.

Okay, great. So the last question, I believe the original plan is to initiate all those studies that you talked about by year end last year. And I understand that the focus was on the Alzheimer's disease program, but are there any specific reason for the delay? Or also, are you able to provide any specifics in terms of timing? When do you expect to initiate those studies?

Yeah, so we were very ambitious last year when we made those plans and you know the attention to detail require really to find us and work on this specific protocol because it's easy to start any trial. It's more difficult to finish a trial successfully and that's what we're aiming for.

So I think we should appreciate that initiating a trial is not difficult. It's about making the trial successful and meaningful for when it's going. And so when you look at each trial, there's always things to consider and you learn to improve it as you go before you really start it.

and we didn't want to rush it, so that's why we want to say we want to do this with right timing, but we will catch up very nicely now with all the trials which we planned to do, and they are still on track to be executed.

Okay, great. Thank you very much. You're welcome.

I don't see any further questions at this time. Thank you.

Good, thank you. Again, we are very much looking forward and we are very excited about the company's potential as we build on biomarker-driven precision medicine studies with significant unmet medical needs and economic burden. And we're looking forward to upcoming data to computer design.

and Parkinson's dementia and Alzheimer's disease with complete data set, as well as Parkinson's dementia open-label extension and the pediatric red syndrome study. Thank you very much.

All right, thank you ladies and gentlemen. This concludes today's conference. We appreciate you participating and you may now disconnect.