Thank you. Good afternoon, everyone. We appreciate you joining us today for Anavex Life Sciences conference call and webcast. Our agenda is to review the company's financial results for the second quarter of its fiscal 2021 financial year and provide a clinical study and business update. A taped replay of this call will be available approximately two hours after the call's conclusion and will remain available for one month. The call will also 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. Dr. Missling and Ms. Boenisch will make prepared remarks, and then we will take questions from equity analysts. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements regarding future events. 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 development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, the need and ability to obtain future capital, and maintenance of intellectual property rights. With that, I'd like to turn the call over to Dr. Missling. Thank you, Clint. We appreciate everyone's joining us on today's conference call to review our financial results and business updates. Let me start with our lead drug candidate, ANAVEX 2-73, which is currently in a phase II/III Alzheimer's disease clinical trial utilizing differentiated patient selection criteria. The study is presently over 98% enrolled and randomized, so we're very close to complete enrollment. What is important in that regard is that the independent Data Safety Monitoring Board, DSMB, for the phase II/III Alzheimer's disease study of ANAVEX 2-73 has completed its recent pre-planned review of the preliminary phase II/III study data. As specified in the protocol, the DSMB reviewed the interim safety data for the phase II/III Alzheimer's study, AD004, and its open label extension, ATTENTION-AD study. Upon review of the interim safety data, the DSMB made the following recommendation. The DSMB recommendation is to continue the studies without modification. This is very encouraging news, and it indicates we are on the right track with these studies. Additionally, ANAVEX 2-73 has been featured recently in a peer-reviewed publication in the Journal of Neuropharmacology titled "Future Avenues for Alzheimer's disease Detection and Therapy" from the series of the special issue on the quest for disease-modifying therapies for neurodegenerative disorders. Separately, the independent Data Safety Monitoring Board, DSMB, also met for the ongoing clinical trial program, including the late-stage AVATAR, RS-002, EXCELLENCE, RS-003, and the US Rett syndrome extension study, RSEP-001 of ANAVEX 2-73, has also completed its recent pre-planned review of the respective interim safety data for these three separate clinical studies. Upon review of the interim safety data, the DSMB made the following recommendation for each of the three studies. The DSMB recommendation is to continue the studies without modifications. This is very good news and indicates we're on the right path with all these studies. As a reminder of our clinical strategy is to clearly differentiate from other biopharma companies in clinical studies in CNS. Anavex is continuing to pioneer the approach of big data, including omics in clinical trials, to leverage the of phenotypic and genotypic precision medicine analysis of whole genome sequencing and gene expression data in drug development. In particular, the potential to identify patients' genetic variants and gene expression changes that may predict increased chance of success for Rett syndrome, Parkinson's disease, and Alzheimer's disease treatments. 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, and good afternoon, everyone. We continue to apply fiscally responsible management of cash utilization with moderate increases within budget. We reported a net loss of $8.2 million for the quarter, or $0.12 per share, as compared to $7.2 million, also $0.12 per share, in the comparable quarter of last year. Research and development expenses were $6.7 million for the quarter, compared to $6.1 million for the comparable quarter of fiscal 2020. The increase is primarily attributable to the continued advancement of our ongoing clinical trials. General and administrative expenses were $2.2 million for the quarter, as compared to $1.7 million for the prior year period. The increase is associated with the growth of our team. Our cash position on March 31st, 2021 was $75.9 million, which we believe is sufficient cash runway for up to three years. Thank you. Now I'll now turn the call back over to Dr. Missling. Thank you, Sandra. In summary, we expect a very data-rich current quarter with data readouts from multiple clinical trials and also the remainder of 2021 to be a catalyst rich year for Anavex. We look forward to providing further updates as advancements continue. I would now like to open the call for questions. Operator, please go ahead. At this time, we will be conducting a question and answer session for equity analysts. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press the tone key if you'd like to remove your question from the queue. Our first question comes from Charles Duncan, Cantor Fitzgerald. Please go ahead. Hey, good afternoon, Chris and team. Congratulations on the progress. Certainly appreciate the update on enrollment in the Alzheimer's program. I had a quick question regarding the DSMB decision recently to continue this study without modification. I assume that not only did they look at safety, but did they look at any efficacy endpoints and/or was there an opportunity to change the sizing, upsize the trial due to, say, data, I'll call it noise or dispersions. That was not done so that data is tracking as you would have anticipated on a blinded basis? The Alzheimer's study DSMB related question? Yes. The DSMB has access to all data, and we understand that DSMB made the decision to continue without changes according to their review. We do know also, though, that the focus on the review was on safety. Okay, they're looking at safety, adverse events. Were they also considering efficacy? Were there any kind of futility analyses? Did they have the opportunity to recommend upsizing the trial based on data dispersion? The DSMB has usually a very independent ability of recommendations, but the DSMB itself, the priority is on the safety assessment. It sounds like in this case they weren't really looking at efficacy at this point. They have access to all the data, so that is the best way I can answer this question. There was not a specific request to look into something like futility. Okay. Can you provide some color on the rollover rates for that study into, say, the open label extension? Can you give us perspective on whether or not patients are going beyond the planned dosing period? Yeah. We have a very high rollover rate from the placebo-controlled part of the study into the ATTENTION-AD extension study, which is a two-year, 96-week-long extension open-label. We happen to reach close to the end of this open-label extension study, and we have received already requests for continuation of patients on this extension study, and we will very likely seek extension of the extension study because of that. That reminds us of what happened in the Phase IIa, which was also originally limited to a extension period. Then because of requests from participants and caregivers and physicians, investigators, it was extended multiple times to end up a five-year extension in total. After the 5-year, as you know, the participants of the Phase IIa study ended up being allowed to continue to study the drug on an exception procedure. This is the feedback we received from the larger Alzheimer's study, phase IIb/III. It seems like a positive relative to the perceived benefit that the patient is getting or lack of tolerability issues. When you mentioned high rollover, could I assume that's like 90% rollover rate or something like that? Secondarily, in terms of the dropout rate within the placebo-controlled portion, what were your assumptions and how well did the trial do thus far? Yeah. Are patients staying on the trial? Right. The percentage is in the range of what you indicated of retention. Extension into the open-label study from what we understand. We have modeled the dropout rate similar to other drugs in this field with Alzheimer's disease. It's a long study, there is in patients With the impairment, like in Alzheimer, with multiple diseases, not only Alzheimer, but also cardiovascular features. There is often this phenomenon that patients do not finish an entire study. We have assumed similar rates as in the other studies in comparable length. I think we are not in any form or fashion different than or worse than these numbers. Okay, thanks. For last question regarding the Parkinson's disease dementia program, were you thinking about going to the agency with, say, an end of phase II meeting? If so, can you provide some color on when that might be? Yeah. No, we said that we would do that, and once the data is completed, we are about to wrap up. You have to understand, in the PDD study, there were a lot of measures included. The CDR System, the UPDRS, the actigraphy, the sleep paradigms, Most importantly, what had been the most time-consuming one, the gene analysis. All this together will be put together in the respective report, and that will be shared with the FDA, and then we will be able to get the recommendation for the pivotal study in PDD. Could that be this quarter or in- We will do it as soon as we can. Okay. Appreciate you taking my questions and the added color. Thank you very much. Thank you. Our next question comes from Raghuram Selvaraju, H.C. Wainwright. Please go ahead. Perhaps your phone is on mute. You may go ahead. We will go to the next question. It comes from Jeffrey Cohen from Ladenburg Thalmann. Please go ahead. Hello, Christopher and Sandra. How are you? Hello. How are you? Doing fine. Just a few questions. First on the income statements. Sandra, can you help us out on the incentive income for the quarter and what that might look like for the balance of the year as far as our modeling purposes? What is the question exactly? I wanted to know about the R&D development incentive income of $1.27 for the quarter and how that may look like for the balance of the year. I think it was $960,000 for the quarter. We expect that will remain consistent throughout the remainder of the year. Okay. Got it. Christopher, can you give us some insight into the two seven three trial, more specifically as far as any discussion with the agency as far as fast track or accelerated approval? For Rett syndrome? Yes. Yeah. We have the first study finished, which was the very first study in Rett syndrome, the U.S. Rett syndrome, RS001 study. We had seen a very positive outcome where we presented top-line data recently last year. We will now be able to share the entire data of the study. With that data, we will go to the FDA and discuss with them the path forward, given that we have two ongoing studies. One is the RS-002 in this age H group with higher doses, and RS-003, which is also higher doses with a younger patient population. We believe that the first study, the RS-002, could be potentially pivotal together with the U.S. study. That is the discussions we like to have with the agency. Okay. Thereafter, we'll explore the approval for the younger patient population with the RS-003. Okay, got it. Any update on the PDD phase II and the AVATAR phase II/III in Rett? Are those timelines still on track? Exactly. The RS001 full data will be this quarter. The PDD study will be this quarter. The release of the top-line data of the RS002 is expected by mid of this year. Okay. That's in the adult population, correct? That's the adult population, higher dose. That's right. Okay, perfect. Those are for me. Thanks for taking the questions. Thank you. Thank you. We have Mr. Selvaraju back online. Please go ahead. Sorry. Thank you very much for taking my questions. I apologize. I must have had a problem with the signal before. I was wondering if you could comment on strategic thoughts regarding the potential commercialization of blarcamesine in Rett syndrome versus PDD, and what implications that may have in terms of Anavex's overall positioning. Are you looking at those indications as opportunities to self-commercialize entirely, or are you looking at each of them differently in terms of the degree to which Anavex is going to be directly involved in the actual sale of the drug? That's a very good question. I think we would be not the first company to market a rare disease ourselves if approved, and that is right now the going plan for Rett syndrome. We have put in place steps in order to prepare for that. For the PDD, we have to be aware, we have to do another study, which we have planned anyway, a pivotal study, because the first study was our phase II proof of concept study. We have some more time to think about the second indication, PDD, in terms of marketing, if we would like to license it or how to structure a partnership if at all needed going forward. This will be something we don't have to decide right now. Rett syndrome, we would be able to market it ourselves to this current plan in the U.S. Pursuant to that, have you made a definitive decision regarding the disposal of the putative priority review voucher that you would be eligible for if you won approval of blarcamesine and Rett syndrome? Would you, in other words, apply the PRV to something else in your own pipeline, or would it be definitive that you would monetize it? Right. This is the same flexibility we are able to retain given that we are planning to also open another study shortly after the Rett study in Fragile X, where we have very good preclinical data, and the drug also is within the family of autism spectrum disorder, like Rett syndrome is as well, and where the drug is expected to be also superior to current treatments or since there are no treatments to current opportunities in Fragile X. Also we have another rare disease, ultra-rare disease, which we have not disclosed. There are different ways to think about that. We don't have to make the decision yet regarding how to address the voucher. Okay, great. One last question. The clinical development timeline with respect to Fragile X, can you just walk us through what you expect the near-term clinical development milestones to be in the Fragile X indication? For approval, you mean? Well, start with the near-term clinical development milestones, the next clinical study. Right When that is likely to start and when it is likely to report data. Right. The RS001 full data will be this quarter. The RS-002 top line will be in middle of the year, and the RS-003 will be in the second half of this year. In between, discussion with the agency, which will determine how the data can be utilized in order to get approval for the drug for patients which have no therapeutic available for Rett syndrome. Thank you very much. Thank you. Thank you. Our next question comes from Tom Bishop from BI Research. Hey, Christopher. I got a couple little questions, but I have always assumed that open label extension study means that everyone gets the drug. Is that correct assumption? Everybody who had participated in the study previously. That is open label extension. For those who had finished the study, either on placebo or an active drug, they are able to get the drug. Not everybody without any association or being not involved in the study. Right. They get the drug for free still? That's right, yes. Nobody has to pay for anything. Okay. Sandra, could you just tell me the number of shares outstanding now? Not average for the quarter, but now. I think we disclosed it in the Q. It should be about $70 million. It should be what? $70 million. $70 million. Okay. I was wondering how many Alzheimer's patients still from the original A273 study, which was 32 patients, are still on the drug. There's a famous graphic that I like that shows the number of patients that were on the medium and low dose that showed a sharp decline in MMSE and et cetera, and those on the high dose showing very little decline. The total of the two, as I recall, was 21 or 22 patients, and I'm just sort of wondering where the others went. Yeah. Good. That was in the three-year interim analysis. Yes. We will be able to share the remainder timeframe possibly in the future, but the patients who have been in the study, they have now been switched over to Eligibility of Humanitarian Device Exemption. That means they're not in the clinical trial anymore because the clinical trial has completed officially, the extension, but they continue to take the drug. I understand that run about, it's less than 21. I think it's between 10 and 21 patients, if I'm not mistaken. And- That's a very encouraging number that there's still people after five years taking the drug. Yeah. That's true. Also, with regards to I've read some articles where other companies that are working on the Alzheimer's indication. One of them has a partner, and the other one's got NIH funding, and of course, Anavex has neither. I think that there's a good reason for both, but I'd rather hear it from you than me. I think we're moving very quickly. When you look at those who get the NIH grants, you have to have published data, and it takes a long time to get a grant. If you get the grant, it takes a long time until you get the money. That's not preferred way of moving forward the asset. We've been very quick in moving forward the assets. The downside of partnering too early is that you are capped with the upside. As a biotech company, you just have not retained the upside for shareholder. By pushing this out, that is advantage of having more upside for shareholders of Anavex. Right. I was just wondering if you've ever had some interest from other people in partnering, or if you just shut them down because you want to keep the 100%? We have always been called upon and knocked on the door to discuss this, and we participate regularly at the conferences like BIO regularly. We are in discussions with the big pharma companies. Again, it has to be a mutually beneficial structure for striking something. We are very excited about our projects, our pipeline, and we like to retain the upside. For that reason, we are proceeding as we speak right now. That does not mean that we will not do a partnership eventually at the right time. What we are aiming for is shareholder value and to maximize it, and that requires to have this flexibility in mind. Okay, last question. The ANAVEX2-73-RS-003 trial or the adolescent trial, is that 003 or 004? 003. I was wondering how the enrollment's coming on that, and what is the size, if you could remind us? Yep. We increased the size from we have set more than 68, 69, so it's going to be more than 69. We have stated that it will be in the second half of this year. Enrollment is going well. All right. Fair enough. Thank you, Chris. No, thank you. Thank you. We have a follow-up question from Charles Duncan, Cantor Fitzgerald. Please go ahead. Hey, Christopher. Thanks for taking the follow-up. Had a couple of questions, one back on the PDD, and the other is on Rett. Going back to the PDD, your answer before, I'm just trying to figure it out. First of all, do you intend to present the data or more findings from that study in the near term? With regard to the genomic analysis, I know that lab function has been a little bit COVID-ified, if you will, in the last year. Would you anticipate, call it days or weeks or months or quarters in which you'd be able to move forward with perhaps in the phase II meeting with the agency? Right. The PDD data will have a lot of data because the entire CDR System has multiple measures. We're talking about a lot of the cognitive domains have been captured in the system very granularly, there is no total CDR System score, they all capture different levels of cognitive domains like picture recognition, word recognition, picture accuracy, memory, word accuracy, and short-term memory, long-term memory, and reaction time, short reaction time, memory reaction time. There are different levels of cognitive tests which are there. That is already a lot of measures which we will present. Then comes the entire battery of what we call more participating measures of the Parkinson's disease, like the UPDRS 1, 2, 3, 4. Then we have the actigraphy, the sleep paradigms. We have two different sleep paradigms. On top of it, we have the genomic analysis of how the SYCP1 moves and what it does for patients and regarding his SYCP1 status. Despite that, we are now there to finish this up, and we expect this data to be announced, presented this quarter, as we speak. The discussion with the agency obviously will follow up very rapidly once we have that. You have to understand, the agency requests a report. The report has to be completed, has to be audited and reviewed and signed, and that basically requires also some additional time. This is now all done, and this will be all done when we submit to the agency. We expect it really to be, I would say, more a question of months. Not days, but not too many months. That's probably the best way to describe it. Okay, that's helpful. My follow-up on the Rett program, just quickly on the safety database in terms of its sizing, given the range of age groups that you're studying. What has the agency said to you in terms of what's going to be required for that safety database? It is a rare disorder, so I imagine it's not too onerous. We included in all our Rett clinical studies an extension study. In the RS001, it's a 36-week study of extension, open label, that was already originally extended before. We have a one-year extension in the RS002 and also the same one-year extension, RS003. Given the history, and we believe these are sufficient timelines for safety, to run safety extension, and from the feedback also from the European EU side of the equation. We believe that what will happen very likely, and that's what Anavex is committing to patients, and that's what we're here for, is that those patients who started a study with Anavex will also have always the chance to continue to stay on the study drug of ANAVEX 2-73. It very likely will also extend these extensions beyond the time period anticipated. Okay, very good. Thanks for taking my follow-up. You're welcome. Thank you. Thank you. At this moment, I would like to hand the call back to Christopher Missling. Thank you very much, and I want to reiterate, we're very excited about our program. We believe we have a really strong pipeline and a platform which allows us to address multiple unmet needs. In summary, we expect a very data-rich current quarter with data readouts from multiple clinical trials in the remainder of 2021 to be also a catalyst-rich year for Anavex. With that, we look forward to providing further updates as advancements continue. Stay tuned, and thank you very much, and have a good afternoon. Thank you. Ladies and gentlemen, this concludes our call today. You may now disconnect.