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spk06: Good afternoon. Welcome to the N of X Life Sciences Fiscal 2022 Second 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 session. During this session, if you would like to ask a question, please use the Q&A box or raise your hand. Please 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 Misling, President and Chief Executive Officer, and Sandra Bonish, 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 the 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 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. And with that, I would like to turn the call over to Dr. Misling.
spk01: Thank you, Clint. We appreciate everyone joining us today, conference call, to review our most recently reported financial results and to provide a business update. We are pleased with the continued advancement regarding our lead product candidate Anavex 273 in Alzheimer's disease and Rett syndrome as we maintain our attention on execution across each of our clinical programs and overall business operations. In the second half of 2022, we are expecting two pivotal top-line results readouts, including top-line results from the randomized placebo-controlled phase 2B-3 study, ANAVEX 273AD004, for the treatment of Alzheimer's disease, and from the randomized placebo-controlled excellence phase 2-3 study, ANAVEX 273RS330, for the treatment of patriotic patients with Rett syndrome. Next month, Anavex will host our R&D day for investors and analysts on Tuesday, June 21st, 2022. This R&D day will include presentations from the company's leadership team with a focus on the company's clinical development pipeline. Additional details will follow closer to the event. In July, a oral presentation of effects of the SIGMA-1 receptor agonist, Blacamecine , in a murine model of Fragile X syndrome, neurobehavioral phenotypes, and receptor occupancy will be presented at the 18th NFX-XF International Fragile X Conference, July 14 to 17, 2022, taking place in San Diego, California. Further pipeline expansion of the ANOVAX platform using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need is expected in 2022, including meeting with the FDA to discuss the ANOVAX273 Parkinson disease program, including a pivotal phase three study. Planned initiation of a Anavex 273 imaging-focused Parkinson's disease clinical study sponsored by the Michael J. Fox Foundation. And a planned initiation of a potentially pivotal phase 2-3 study in Fragile X, the most frequent genetic cause of autism spectrum disorder. and a planned initiation of a phase 2 slash 3 clinical trial for the treatment of a new rare disease indication, and planned initiation of ANAVEX 371 phase 2 clinical trial for frontal temporal dementia, schizophrenia, and Alzheimer's disease indications. 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.
spk00: Thank you, Christopher, and good afternoon to everyone. During the quarter ended March 31, 2022, we continued to maintain fiscally responsible cash utilization as we expand and advance our pipeline. Our cash position at March 31, 2022, was $153.3 million, which we believe is sufficient cash runway to fund our operations and our clinical programs beyond the next four years. Our research and development expenses for the second quarter of fiscal 2022 were 8.6 million as compared to 6.7 million for the same quarter of fiscal 2021. General and administrative expenses were 2.9 million compared to 2.2 million in the comparable quarter of 2021. Overall, we reported a net loss of 10.4 million for the quarter, which is 14 cents per share. The overall increase compared to the previous year period is primarily related to an increase in non-cash compensation charges, period over period, which is driven by the addition of staff to manage and support our clinical studies and development. Thank you, and I'll turn the call back over to you, Christopher.
spk01: Thank you, Sandra. So we're looking forward to the next month's R&D day events where we will present our broad Sigma-1R platform portfolio, which allows us to expand further within the neurodegenerative and rare disease space. And we remain on track to deliver data readouts as well as presentations and medical meetings. and initiating biomarker-driven precision medicine clinical studies throughout the rest of the year as planned. I would like now to turn the call back to Clint for Q&A.
spk06: Thank you. Christopher, we'll now begin the question and answer session. If you have a question, please raise your hand or enter it into the Q&A box. Our first call is coming from Yunzong at BTIG.
spk05: Go ahead, Yun. Hi. Yeah, thank you very much for taking the question. So on the pediatric Rett syndrome study, and I see that the study has not completed patient enrollment, so I assume it's still ongoing. So I wanted to confirm, if you're going to put out the press release on patient enrollment completion and on the primary endpoint, Is it reasonable to assume that it's still going to be the AUC? And have you talked to the FDA on the, I believe the last guidance or last, yeah, business guidance after the second data readout from the Rett syndrome was that you were going to talk to the FDA. So has that happened yet, please?
spk01: Thank you for the call. Indeed. So the last communication is that we are planning to meet the FDA to discuss the RET program and its procedure to move forward with filing an NDA for approval. And since we finished and completed the avatar study in adults, a small study, despite the fact that it's a successful study, a phase two study, which was also small, and the ongoing excellent study, which is in patriotic study, which is the largest study. So we are waiting for this meeting to take place. It has not yet taken place, but it will take place soon. And then we will learn how to move forward. And indeed, the RET excellent study with patriotic patients is still ongoing and enrolling. And we might have a press release when the enrollment is completed.
spk05: Okay, so with regard to the primary endpoint, it's still going to be a RSPQ-AUC instead of RSPQ.
spk01: That's right. So when we have presented avatar study, we learned from the first phase two study that the RSPQ-AUC, that includes the CGI-I linked responder analysis. So the RSPQ-AUC, includes the CGI respond analysis, linked respond analysis, that is the endpoint which we will also propose for the excellent study. That is correct. It's consistent with the avatar study.
spk05: Okay. So the second question is on the Parkinson's disease program. And can you remind us what you would like to achieve with the imaging study? And do you need to talk to the FDA before you initiate that imaging study?
spk01: It's a good question. So the goal is to show what we have already seen with the preclinically that the Sigma one is completely clearly dose dependent target engaging the Sigma one receptor in the brain. And that is a additional confirmation in humans, and among them also in Parkinson patient that's why we were able to receive the full support, non diluted funding as a grant from the Michael Fox Foundation for this study. And we probably will very likely use that opportunity to meet also with the FDA to discuss the Parkinson's program in its totality, including the phase three, which we said we are happy to move forward with given the successful phase two PDD study.
spk05: Okay, great. Thank you very much. And we look forward to the R&D date in June. Thank you very much.
spk06: Thank you. The next call is from Pete Stavropoulos from Cantor. Go ahead, Pete. Pete, I think you're muted.
spk04: Hi, Christopher. How are you? Good. How are you? Good. Thank you. So I don't know if I've missed it in the previous question, but I know that you haven't spoken to the agency recently, but from previous discussions, do you have a sense of whether or not you're going to need to wait for the pediatric data to file for the adult indication?
spk01: So the patriotic data is a larger study. And in theory, if you would file for adults, you would not need it because it's a different age group. But what we believe is probably a prudent assumption is to include the patriotic study in its totality for the RET program. But as we stated, we don't know that yet until we meet the FDA for guidance on how to move forward in terms of regulatory filing for approval of Anavec system 3 for RET syndrome.
spk04: All right, thanks. Thanks for the clarification. So I also wanted to ask about your thoughts regarding sort of the lessons, the takeaways from the Rett syndrome experience with 273 and their applicability to potentially, you know, clinical development initiatives with the compound, say, in Fragile X. And if you could give us, you know, a sense of when you anticipate the Fragile X program to initiate patient enrollment.
spk01: Sure. Right. So we are very excited about the Fragile X program for two reasons. First of all, we have very solid and it is a very strong evident animal model in Fragile X, which was published last year. And there's new data coming out. And among them, it will be presented also at the conference in July, which we pointed out. and there will be additional biomarker information making very clear of pathology, biomarker of pathology, making clear that the drug really improves the phenotype of this disease, which is the largest autism spectrum disorder. And why it's exciting for a second reason is because this largest autism spectrum disorder is like Rett syndrome, under the autism spectrum disorder, and we measured the ADAM score, which is a key measure of anxiety, which is a known feature of limitation and problem for these patients with autism. And we were very successful in the both RET studies in the phase two and in the phase three avatar to the successful improvement with the drug on this endpoint of the ADAM score. And that is why we're very excited both from the clinical data as well as from the clinical data side of point of view. So what we are now doing, we want to make sure that the protocol is very robust because the challenge of Fragile X, it's a very diverse patient profile. So there are very different features of the disease, which is not similar. And we want to make sure we are using a population, a trial population, which is as homogeneous as possible. So in order to avoid a trial failure, because not the drug doesn't work, but because the patients are so different and the endpoints you selected for these patients don't apply to all. And it is a key what we're now in the process of figuring out. Then we will meet with the agency. and confirm that approach and also make sure that we can run this as a pivotal study. So we expect this to take place in the second half of this year.
spk04: Okay and then in the same at the same time will you be also consulting with the EMA or that'll be at a later time point?
spk01: That's right. Since we will include most likely also patriotic patients, we will also include the discussion with EMA, which is important because they want to be also have a discussion before that trial starts. Okay.
spk04: And just one last question on the Alzheimer's program. Can you provide any type of color on the rollover rate, you know? from the phase 2b3 into the open-label extension?
spk01: Yeah, so the last I heard was there was over 90% rollover from patients who finished the placebo-controlled study in the open-label extension. So that's a very positive sign. And we're very excited because we're getting really close to finishing the study of the last patient out, and then we can start the process of data cleanup as well as then locking the database and then subsequent releasing the data. And we're very excited about this.
spk04: Excellent. Thank you very much for taking our questions.
spk01: Thank you, Pete.
spk06: The next question is, I'm guessing from Sumit Roy at Jones Research.
spk03: Hi, this is Sumit here.
spk06: Okay, great. Sorry.
spk03: Congrats on all the progress. Question on the Alzheimer front. Could you give us a little... find a detail on when should we think the data to come out? Is it still, is it third quarter or fourth quarter? And
spk01: It's a good question. So since we said second half, I like to stick to that because we don't know exactly how long the data cleanup takes. And if it's quicker done, performed, then it might be in the Q3. And if it takes longer, then it will be just slipping into Q4. So it's best really to call it Q second half 2022. But when we have more clarity, we'll provide a closer update.
spk06: Was that the only question?
spk03: Thank you for taking the question. Now that's up. Thank you.
spk06: Great. Thank you. I have one question from from H.C. Wainwright. And he said, what are the key points of the agenda for your upcoming meeting with the FDA? with the Parkinson disease program pivotal study, for example, with a biomarker endpoint be pushed up in priority, owing to your recent success with Sigma-1 mRNA expression data in phase two.
spk01: This will be all on the agenda. And since we are sharing this data very timely now, and we want to also make sure we are able to include the extension data of the Parkinson's study. And since this is now completed, and once we have that, we will be able to have a bigger picture of the Parkinson's program. And the items you just referred to will be all discussed.
spk06: Okay, a second question for Moose is, can you give us a preview of the new indication that you're excited about in the neurodegenerative and rare disease space? that you'll be showcasing at your upcoming R&D Day event.
spk01: Right. So we will have the ability to choose between several rare disease indications. And that's why we have it kept like that. And it really shows the worth and the value of the platform we have. And it's backed by preclinical data on different indications. And so we want to make sure we are prioritizing the right rare disease if we are comfortable with the clinical design to show efficacy. And that's really what we're working on. So that's why we didn't mention what indication it is. But there are different indications, separate indications, independent indications, which could become the indication which we will release once the trial starts. And it's only because we have the ability to showcase several rare disease indications being demonstrated positively impacted by the drug adavexel serum 3 in respective clinical animal models.
spk06: Amuz, I see you're in the chat now. You can go ahead and ask your own questions.
spk02: Perfect. Thanks. Yeah, I'll save you some trouble. Hi, Chris. Thanks for taking our questions. So in terms of your upcoming 273 image focused Parkinson's study, we were wondering if you collected imaging data from the phase two trial. And if you did, could this methodology from your current study be used to combine the data?
spk01: If I may ask, combine the data with what exactly?
spk02: If you may have collected imaging data in the phase two trial, or you did not collect any imaging.
spk01: Yeah, we did not. In the phase two Parkinson's disease dementia study, yeah, there were no imaging study collected. And that's why this imaging study separately is now taking care of that.
spk02: Okay, understood. And in terms of 371 for AD, will you use the same cohort characteristics, or do you think this drug could potentially differentiate from 273 and be more efficacious in certain subpopulations of AD patients? Okay.
spk01: It's an excellent question. So we're expecting that there will be some additional data on 371 preclinically also to give us guidance on this to fine tune the indication. But right now, without any further knowledge on this, it could be the best choice for going into patients with AD which have the best, I would say, cohort consistency and homogeneity and also availability to make the trial as robust and as quick as possible in its enrollment. So this will be more likely the early Alzheimer's disease patient, similar to what the phase three of the ANAVEX 273 study is right now.
spk02: Okay, understood. And just finally on 371, we're looking forward to this one. Could you expound briefly on the strategy for the three indications for this program? So clearly FTD appears to be a front runner here. How confident are you in the schizophrenia indication, given the sigma one receptor activation has been associated with off target effects and psychosis?
spk01: Yeah, so we actually were very excited because 371, as a reminder to everyone, is not only a sigma-1 agonist, but also an M1 agonist. And there are trials out now which has been shown as very successful in this indication of schizophrenia with pure M1 agonists. And if you now look at what we heard from the inventor of Anavex 371, who always told us that he looked at M1 agonist as a target, and he found by accident, so to speak, Anavex 371 being more potent than all the other previous drugs he had developed as M1 agonist. And we looked at the profile of this 371 molecule. He saw that there was not only M1 agonism, but also sigma 1 activity. So he postulates that the 3.71 in schizophrenia would be even more proactive and successful, possibly because of the Sigma-1 activity. And so that's why we're excited about the 3.71 in schizophrenia as well.
spk02: Okay, brilliant. Thanks for taking our questions. Good luck this year.
spk01: Thank you very much.
spk06: Yun, it looked like maybe you had a follow-up question, or?
spk05: Yeah, thank you very much for taking the follow-up question. So it looks like you have a lot of milestones planned for the second half of this year. And so I wonder, I'm now questioning the capacity to be able to complete all the milestones. Seems a lot of activities. But if you have to talk about the priority, which one do you think could be the most important one that you think for the pipeline development?
spk01: I think it's really consistent with the bullet points you have seen today. So it's really finishing the Alzheimer's study, which is an autopilot. So we just have to do the clean up work, if you so like. And the same is finish the RET study. But then following with a priority, I think it would go into Fragile X study, given that's a relatively short study. and can be pivotal potentially, and it's a huge unmet need, and it's seven times the size of Rett syndrome in terms of indication number of patients. But then also following up with a Parkinson disease pivotal study, And also, I would not rule out frontal temporal dementia and also schizophrenia, especially schizophrenia for 371. When I say frontal temporal dementia, I mean for 371, because schizophrenia is relatively short study, and that obviously would be important to that. But also, I don't want to forget to mention the rare disease, which we have not yet given the name for, the indication, and to do a pivotal study in that indication. So really consistent with the bullet points you have seen.
spk05: Okay, great. Thank you for the confirmation.
spk01: Thank you.
spk06: Looks like we may have a follow up question from Pete as well. No, maybe not. Um, Christopher, I think that I have no further questions at this time, so you can continue.
spk01: Thank you very much. Again, to reiterate, we are looking forward into the remainder of 2022. We're very excited about the company's potential platform, especially as we build on successful completion of two important biomarker-driven precision medicine pivotal studies, and we're looking forward to these pivotal clinical readouts in Alzheimer's disease and patriotic syndrome. But also, we are very excited to move forward with the planned studies, which we really want to initiate because of its unmet need, and we're very excited about this. So look forward to updates and reach out to us for questions.
spk06: Thank you, Christopher. Ladies and gentlemen, that concludes the call today. Thank you for participating and you may now disconnect.
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