Good morning, everyone, and welcome to the Anavex Life Sciences Fiscal 2023 first 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, use the Q&A box or please raise your hand. Note that this conference is being recorded. The call will be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sandra Boenisch, 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 company's filings with the SEC. 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 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. With that, I would like to turn the call over to Dr. Missling. Thank you, Clint Tomlinson. We appreciate everyone joining us on today's conference call to review our most recently reported financial results and to provide a business update. We are excited with the continued advancement of our lead product candidate, ANAVEX 2-73, in Alzheimer's disease and Rett syndrome as we maintain our attention on execution across each of our clinical programs and overall business operations. We were very pleased to present top-line data of the randomized double-blind placebo-controlled phase IIb/III study for the treatment of early Alzheimer's disease at the CTAD Congress 2022 on December first. The trial met both co-primary and secondary endpoints, showing statistically significant reduction of clinical decline as measured by those endpoints. We are excited 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. We believe that our precision medicine platform and novel central nervous system mechanism improve the chance of clinical success. We are pleased by the results of the placebo-controlled Phase 2b/3 Alzheimer's disease trial, which data suggests that ANAVEX 2-73, blarcamesine, an orally available small molecule activator of the upstream Sigma-1 receptor, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity and might be at the forefront of biomarker-guided, pathway-based targeted precision medicine drug development. 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 Rett syndrome. With a deep portfolio of promising therapies, we believe that Anavex remains well-positioned to address the urgent needs of patients affected by neurodegenerative and rare neurodevelopmental diseases. Going back to the Rett syndrome program, we announced recently on February 2nd last week, the completion of enrollment of the randomized placebo-controlled EXCELLENCE phase II/III study for the treatment of pediatric patients with Rett syndrome. We expect to announce top-line results from this study in the second half of this year. In Parkinson's disease dementia, we are planning to announce the data from the 48-week open label extension of the previously successfully completed phase II study. In other indications, recent communication with the FDA confirms our strategy to advance ANAVEX 2-73 for the treatment of Fragile X syndrome. 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 Anavex platform using gene biomarkers of response applying precision medicine of neurological disorders is expected, including planned initiation of an ANAVEX 2-73 imaging-focused Parkinson's disease clinical study sponsored by The Michael J. Fox Foundation, a planned initiation of a phase II/III clinical trial for the treatment of a new rare disease indication, and the planned initiation of ANAVEX 3-71 phase II clinical trial for schizophrenia. Last but not least, we expect several clinical publications involving ANAVEX 2-73 and ANAVEX 3-71 and a Rett syndrome burden of illness study. 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. Thank you, Christopher. Good morning to everyone. We continue to demonstrate operating fiscally responsibly. 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. 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. Overall, we reported a net loss of $13 million or $0.17 per share, inclusive of $5.3 million in non-cash compensation items. Our cash position at December 31st, 2022 was $143.6 million. During the quarter, we utilized cash and cash equivalents of $5.8 million to fund our operations. 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 pre-guidance in previous quarters. 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 IIb/III study, ANAVEX 2-73-AD-004, and the manufacture of additional clinical trial supply for upcoming pipeline programs. Thank you. Now back to you, Christopher. 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. 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 gonna come from Soumit Roy at JonesTrading. I think you can go ahead, Soumit. Hi, everyone. Congratulations on the progress. Could you give us a little color on what kind of details on the Alzheimer's disease data we are going to expect? Are we going to see some MRI data or time course of how the reduction in the cognitive decline has occurred or something like that? 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. Among them is MRI, which is a very important marker of pathology, which is the most accurate. It's a picture of the brain, and it's very well described that the brain atrophy moves in this pathology aggressively. That will be part of the analysis, as well as additional biomarkers of pathology like Aβ and tau, as well as the biomarker which are specific to Anavex, which is the Sigma-1 variant analysis, which was clearly pre-specified. You remember we noted that patients with a wild-type Sigma-1 receptor did much better compared to those who had a variant. Because variant carriers were in the minority, often that signal overall was not affecting the significance of all patients. It was notable that there was a better outcome in patients with a wild-type Sigma-1 carrier status in previous studies. We are looking forward to seeing how this plays out in this study as well. 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 of this within the study. 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 Alzheimer pathology. Thank you for the detail. That was really helpful. Should we expect the data to come out first half of this year, or it'll be more like second half would be our expectation? We actually try to do this as soon as possible because we want to share that also with the agencies at the FDA in Europe. We are really keen to do that as soon as possible. At this point in time, it's too premature to give guidance on the timing, but you can be assured we do that as soon as possible. Great. Thank you so much, for taking the questions and congrats on all the progress. Thank you. The next call comes from Yun Zhong at BTIG. I think you can go ahead, Yun. Hi. Good morning. Thank you very much. We'll take your question. Christopher, can you talk about your plan for the regulatory discussion with the FDA on the Alzheimer's indication? Talk to the FDA? Sorry, Bit of cut off, so do you mind repeating the question? I'm sorry. Can you ask that again? We had a glitch. No problem. Yeah, 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? That's correct. The FDA engages when you have data and that's exactly where we are. The data means a complete data set. As far as possible, that's why we're also 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. Switching to the Rett syndrome study, I believe the press release announcing over-enrollment had the language that was the FDA's input. You are using the primary endpoint. I wanted to confirm that the primary endpoint is RSBQ AUC similar to or the same to the one used in the AVATAR study. Has the FDA agreed that the AUC, the modified RSBQ scale, can be an appropriate endpoint for a Rett syndrome study? We have it in described in ClinicalTrials.gov, and it was also never changed in ClinicalTrials.gov for the EXCELLENCE study. It is the RSBQ is primary endpoint, and the CGI is key secondary endpoint over the course of the trial. Is that the same endpoint that was used in the AVATAR study? It's slightly different, so it's actually the measurement over time from beginning to end of trial. not AUC? Not AUC. Not AUC. Exactly, yes. Okay. The study is large enough that it can carry the signal by itself without AUC. Okay, great. The last question, I believe the original plan is to initiate all those studies that you talked about, by year-end last year. I understand that the focus was on the Alzheimer's disease program, but are there any specific reason for the delay? Also, are you able to provide any specific, in terms of timing, when do you expect to initiate those studies? Yeah. We were very ambitious last year when we made those plans. You know, the attention to detail require really to finesse and work on the 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. I think we should appreciate that initiating a trial is not difficult. It's about making the trial successful and meaningful for its, for when it's going. 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. We didn't wanna rush it, so that's why we wanna say we wanna do this with the right timing. Obviously, we will catch up very nicely now with all these 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. Christopher? Good. Thank you. Again, we are very much looking forward, and we're very excited about the company's potential as we build on biomarker-driven precision medicine studies with significant unmet medical need and economic burden. We're looking forward to upcoming data readouts in Parkinson's dementia and Alzheimer's disease, with complete data set, as well as Parkinson's dementia open label extension and the pediatric Rett 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.