Good morning, all. Welcome to Neuren's Investor Webinar to discuss the positive outcomes from our end of phase II meeting with the U.S. FDA, regarding the proposal for the first-ever pivotal clinical trial program for Phelan-McDermid Syndrome. My name is Gerry Zhao, VP of Corporate Development at Neuren. Joining me on the call today from Neuren are Jon Pilcher, CEO, Liza Squires, Chief Medical Officer, and Nancy Jones, VP of Clinical Development. Jon and Liza will lead the discussion, then all of us will be available for Q&A. You can use the Q&A button to submit your questions. Before we start, I would like to remind everyone that we'll be making forward-looking statements during today's call, which are subject to risks and uncertainties that may lead to different outcomes. I'll now turn the call over to Jon to start the discussion. Thank you, Gerry. Good morning, everyone. Thanks very much for joining the call today. It's a normal working day in Victoria, where I am, but I'm aware it's not in many parts of Australia, so I really appreciate those of you who are joining on a public holiday. But we'll try and keep this to thirty minutes. I think we should be able to do that, and there will be a recording available for people who've been unable to join. So, in a minute, I'm going to ask Liza to run through some of the details from the meeting, but I just want to provide some context. Before you're aware that Phelan-McDermid Syndrome, there is no approved treatment currently, but it's much more than that. There's never been a pivotal trial in Phelan-McDermid Syndrome. To my knowledge, there's never even been a proposal for a pivotal trial, so really, you know, we, both we and FDA are breaking completely new ground here, and that's particularly relevant for how you measure efficacy. That's probably the most challenging thing when you're breaking completely new ground. Now, set against that, we're sort of encouraged that we're dealing here with a particular division of the FDA, which is the Division of Neurology 1, which is the division in which Rett Syndrome was and is managed, and of course, we had a very good experience with them with Rett Syndrome and a very collaborative approach. However, there's a few differences here compared with the Rett Syndrome situation, and one, it relates to endpoints. There is no equivalent to the Rett Syndrome Behavior Questionnaire, which those of you who were with Neuren in the past will know was the main endpoint in the Rett program. There is no equivalent to that for Phelan-McDermid Syndrome. And perhaps more importantly, you know, when we went to end of phase II meeting with Rett, we'd done two placebo-controlled clinical trials, testing five different doses across about 80 patients. By contrast, with Phelan-McDermid Syndrome, we've done one open-label phase II trial in 18 subjects with one dose group. So very, very different situations. Now, there's a very good reason why we've taken that much more aggressive approach. In our belief in the drug, the very high quality of the non-clinical information, and also a desire to move more quickly, both for shareholders and for patients. So a very good reason why we've done this. However, this is the first time we've been in front of FDA, having done those, that phase II trial, and as you know, in other indications. So really, really important meeting. You know, it really was an important meeting and challenging. And I think, you know, given all that context, we're extremely happy with the outcomes that we've got out of the meeting, and also the conduct of the meeting, the collaboration with the division. We've achieved alignment on everything we wanted, except that we have to submit some more information to confirm the efficacy endpoints and their analysis. Now, what we have to understand is that 95% of the meeting was actually spent talking about options for efficacy endpoints, and we've actually had some dialogue with the agency since the meeting as well. So this is not a situation where we're on a drawing board trying to find what to use. This is, you know, we think there's a way forward here, after a lot of discussion with FDA, and we just have to provide some more information, to reach that final agreement. I just want to point out, you know, we're not... When we get to Q&A, we're not gonna discuss specifics about endpoints in today's meeting. That remains confidential between ourselves and FDA until we've reached that agreement. And it also means that today I can't provide an update on, a detailed update on timelines and costs. What I would say is that overall, my expectations haven't changed on both of those things, and we will provide a more detailed update on that, as soon as we're able to, when we have the agreement on the endpoints. To Liza to step through the things that we've agreed with FDA and perhaps, you know, give her perspective of the meeting. Thank you, Liza. Thanks, Jon. Good morning, everyone. As Jon mentioned, the outcome of the meeting with the FDA was positive and the tenor was very collaborative. The agreements that we've reached include that we will be doing a single randomized, double-blind, placebo-controlled trial with 13 weeks of treatment in children ages 3 to 12 years. There'll be one active treatment group versus placebo at a target dose equivalent to our phase II study. Really, this means that the dose, the duration of the study, and the study population are very similar to that of our phase II program. Additionally, the agency agreed in principle, subject to review of our final protocol, in a less burdensome safety monitoring scheme. This is really going to be welcome, not only by the participants and their families, but also by our study sites. The placebo-controlled double-blind portion will be followed by an open-label extension study. This makes our program very similar in many ways to what was done with the Rett Syndrome program, where there was a single pivotal of 13 weeks, followed by the open label extension program. Neuren's continuing to actively pursue other preparations for the phase II program, including ongoing study site identification and selection of service providers, as well as manufacturing of the NNZ-2591 supplies. Jon, I'll hand it back over to you. You're on mute. Oh, sorry, I'm on mute. I'm not anymore. Thank you. Thanks a lot, Liza. We can now move to Q&A. There were a lot of questions pre-submitted, and there are some ones that have been submitted while we've been talking. Let me just step through these. There's some of them that I've sort of preempted or answered, but I'll read them all anyway, so that you're aware of what's been asked. Firstly, what would the breakdown of costs look like for a phase III trial, noting the previous guide of between $50 million and $100 million for each particular indication? As I've said, I'm not going to provide any more detail than that, other than, as I said, my statement was that my overall expectations haven't changed, so I still think that that range holds. We'll provide more detail when we've confirmed the endpoints. Secondly, what preparations has Neuren done so far to support recruitment of Phelan-McDermid Syndrome patients for when the trial commences? Liza, do you want to make any comment about that and then perhaps about the foundation? Sure. So, we are indeed. We've been engaged with the PMS Foundation as well as the CureSHANK group. We meet with them on a fairly regular basis, attend their conferences, and are partnering with them to be sure that we have the patients available and informed, ready to start the trial. We're also doing a assessment of several study sites to understand better the geography and the best location of available sites. Thank you. Next question: Was there any progress on updates to the future phase II trial protocols? Okay. This is talking about if we do future phase II trials in other indications. I think it's asking, is the simplified safety monitoring program that we've in principle agreed with the FDA gonna be applicable to those phase II trials? The answer is that there, you know, this was a meeting specifically about Phelan-McDermid Syndrome and the phase III trial. It wasn't about anything else. However, we feel pretty confident now that indeed, if we run future phase II trials, they won't need to have the overly burdensome protocol that the ones we've conducted have had. We will have to... If we have new indications, we'll have to have pre-IND meetings with the FDA, which will confirm that. Next question. Many investors wish to be informed regarding any discussions concerning partnering and/or takeover options. Obviously, there are confidentiality considerations, but what can management inform shareholders with regard to this? As always, it won't surprise you to hear, I'm not gonna say anything about takeover. It's not appropriate to do that. Partnering, you know, we've said before, we've had interest from people in partnering at this stage. Continues to be interest. I don't believe that's a partnering deal at this stage will add anything like the value of continuing to a positive phase III result. But we're still having discussions with people. Right, next question. With worldwide focus on traumatic brain injuries, Neuren liaising with universities and researchers to supply NNZ-2566, which is DAYBUE, for further investigations into its efficacy for TBI, stroke, or even other rare neurological conditions. So if this question is about NNZ-2566, trofinetide DAYBUE, that's wholly in Acadia's camp. They have exclusive rights to everything for that, so that's completely up to them. If the question was aimed at two, five, nine, one, as I said before, we're not currently focusing on TBI or non-orphan indications such as stroke. When do you expect approximately the phase III trial to be completed, and when will Neuren get registration approval? So yeah, sorry, it's too early to be giving those sort of timelines out. As I've said, we'll give more indication of the timelines when we have-... agreement on the endpoints, and particularly, you know, information about the start of the trial. Next question: When will you let the market know the other indications that are being prioritized? So again, in case anyone's not aware, so we are doing preclinical work on other potential indications for NNZ-2591. That's ongoing at the moment. Haven't given an exact timeline for that. I'm hoping we might be able to say something by the end of the year, or early next year. One other thing, that's important to understand with these new indications is that we have to make sure our intellectual property, our patent position, is confirmed before saying anything publicly. Next question: Is there any deadline for Neuren to submit further information to FDA to confirm the endpoints for the primary efficacy assessment? Liza, do you want to make a comment about that? There is no deadline, but we are working closely with the FDA to progress this as rapidly as possible. And I think, you know, just to echo what both I and Liza said, you know, we've had a very collaborative approach from the FDA so far, so we certainly hope that's gonna continue in this extra piece that we have to do. Next question. This is the same one: When can we expect an update or disclosure of preclinical results of undisclosed indications? I think I've answered that one. Next question: How much money will you need to complete this phase III on your own? So I think it's already the range has already been talked about. So that's the sort of range I think we're talking about. Of course, we have more than... a lot more than $ 200 million in the bank currently, so we're very well funded to do it. Excuse me. Are there any external organizations willing to partner? So again, I think I've answered that in a previous question. Congratulations for the constructive end of the phase II meeting. Thank you. You had promised at the last conference call that you were gonna give more details about the interest of Big Pharma in NNZ-2591 or Neuren. So I think again, that's aimed at takeover or partnering, and I think I've answered both of those things. Right, that's all the pre-submitted questions, so let's move on to others. So what are the important announcements to look forward to till the end of 2024 and in 2025? So yeah, there's an awful lot happening. And some of them we've talked about already. Obviously, there will be the agreement with FDA on the efficacy endpoints, which will allow us to then give more information on timelines and costs. There is the new indications that we've already talked about in Q&A. Acadia will give their next quarterly update in November, which will be very important for DAYBUE. Of course, into 2025, there'll then be quarterly updates on those sales. Also, we may well get a decision from Canada for DAYBUE, hopefully an approval decision from Canada, before the end of the year. Then Acadia has said that they expect to file the application for DAYBUE in Europe in the first quarter of next year. So again, that'll be an important announcement. And then, of course, we have our other indications with NNZ-2591 that we will certainly be in dialogue with FDA on those indications at some point, so there'll be news about that, too. So a huge amount happening both in the last three months of this year and into next year. Next question: Can you provide more color on the number of patients you expect to enroll? Look, I'm not gonna do that because we really need those endpoints confirmed before we can do that. I mean, all I will say is that I've obviously referred in the past to the Rett Syndrome; it was 180. So, you know, we're not talking about hundreds of patients here, but it's a relatively small trial, which is one good reason why we're very capable of executing it. But again, I'll give color on that number of patients when we get agreement on the endpoints. Next question: Is there an approximate time when the agreed endpoints will be known? I think Liza's answered that there isn't a prescribed time, but we will move as quickly as possible, and hope the FDA will do likewise. Are there any changes to manufacturing suppliers of NN`Z-2591 between phase II and phase III? So yes, there are, but that's all been done some time ago. So, we did move for phase III to bigger manufacturers that could be the commercial manufacturers. Of course, you have to test your commercial products in phase III, made with the commercial process. So we did change suppliers, but as I said, that's some time ago. Been a lot of work going on this year in that regard, and we're well into the manufacturing campaign to make the product at the new manufacturers, who could be the commercial manufacturers for the phase III trial, so we feel very confident about that. Next question: How many trial participants will there be? I think I've just answered that one. Could you provide an update on any discussions you have had or not had with FDA regarding additional undisclosed indications? So, there haven't been any because there can't be any until, as I said, we've got the pre-clinical results and we've confirmed our patent position. Then we would go, we'll tell you all first, and then we would go to FDA to have those discussions. Next question: What is the timeframe on hearing back from FDA on endpoints? I think, again, Liza's answered that. Can you confirm if the additional data to be submitted is already available? Any guidance on how long it will take to assemble such data? Slightly different angle of that question. Liza, do you want to make a comment on that, particularly about the additional data? The additional data is being assembled and analyzed, so that we still have some work to do. But, as you can imagine, this is a bit of an iterative process, but we're moving again. I just have to stress, we're moving as rapidly as possible. I think part of the question was just saying, is it-- is this information already available? Yes, it is important to say this is... We haven't got to do other studies or generate other information. The information is available, we've just got to compile it and submit it. Next question. In fact, there's a few questions in this one. How is the preparation work going for Pitt-Hopkins? Any indication when the end of phase II meeting will take place? Look, I always said that this, the feedback we got on Phelan-McDermid would be instructive of Pitt-Hopkins because it's the same division of FDA, and we're in a very similar situation. There's no precedent at all here, so the breaking new ground is exactly the same with Pitt-Hopkins. So I think it's all the information we've got, and everything that we've aligned with on FDA, I think is really useful and really relevant for Pitt-Hopkins. We haven't fixed an end of phase II meeting yet, so don't have any timing for you on that. We'll let you know in due course. Second question. The share price has been disappointing year to date, and in fact, it's one of the worst performers on ASX 200 in the context of broad positive market. Market does not seem to buy into the NNZ-2591 story. What's your view on this? So I don't think it's anything to do with NNZ-2591. I think it's completely to do with DAYBUE, and maybe I'll come back to that in a second. Obviously extremely unhappy with the share price this year. I would point out that we were the best-performing stock on the ASX 200 last year. So I think, you know, you need to view this in a longer-term context, but I won't shy away from incredibly disappointed this year. I do think it's completely to do with DAYBUE. You know, it's very clear that some shareholders sold, leading into Acadia's announcement, where they downgraded their sales guidance and continued to sell after that. And if you have multiple institutions selling at the same time, then it drops the price, in whatever situation you're in, and I think that has changed sentiment. And remember, it came on the back of a short report, which was complete rubbish, but still, you know, sows a seed of doubt in people's minds. I just feel that the sentiment on DAYBUE, you know, has changed in that period. That's why NNZ-2591 is so important, but it's not all about DAYBUE, and I've always said that. You know, the big value opportunity in the future is NNZ-2591, and it is a much bigger opportunity than DAYBUE. Having said that, you know, with DAYBUE, I think, you know, we're very encouraged by all the metrics that Acadia has put out, both at the last quarterly and since. And so we're very hopeful that what is a great story still from a sales point of view will continue to build in the future, and we think there's a hell of a lot of upside and, of course, other territories to come on stream. So there's a huge amount left in the DAYBUE story, but for me, that's what's causing the share price to be very... It is not about NNZ-2591, and certainly, that's what I hear from people. Third part of this same question. While it's good to see the buying from one director, as a shareholder, it would be more positive if more management members and directors buy on market, given where the share price is. So look, you know, completely entitled to that view. If you think it's gonna influence the share price, you can't keep doing it. You know, you can't keep having directors continually buying, and then they're never allowed to sell. I mean, that's not a tenable situation. So, you know, in the end, it's an individual decision for every shareholder. We've got big shareholdings. Certainly, you know, some of us have got very big shareholdings now. I don't really see any need to add to them. I don't think we should be trying to manipulate the share price. Next question: What about the number of participants in phase III? I think we've answered that one. What is the timeline for the next meeting with FDA about endpoints? We don't think we necessarily need a meeting. We need correspondence, and that's what Liza's talked about us doing as soon as we can. Regarding PMS, would it be fair to assume for a trial like this, patient number would be more in the less than 50 range rather than hundreds? No, that's not right. Certainly for a phase III trial, that would be incredibly-... unusual, and that's because it's not just about efficacy, it's about safety. You know, FDA want to see a certain number of patients having exposure to drug for a certain length of time to be confident about the safety profile. So no, it will certainly be more than a hundred. How many more, as I said, to be determined once we've fixed the endpoints. Can you provide an update on where to for Pitt-Hopkins following the positive phase II results in that syndrome? I think I've answered that one. Maybe just to add again, you know, we think there's a great opportunity there and feel very good about it, but we'll have to go through the same journey with the FDA. What is the anticipated start date of the phase III trial? As I've said, I'm not gonna talk about detailed timelines today. We will do that as soon as we have agreement on the endpoints. And then one. Oh, no, Oh, no, it's not a final question. There are more, sorry. What details can be provided on the manufacturing of NNZ-2591 for the phase III trial and preparations for a commercialized stage? So I've talked about that a bit. As I said, we're well into the manufacturing for the phase III trial. Obviously, it's a campaign that runs for a period, and we'll manufacture more as the trial continues, but we're very comfortable with where it's sitting. And as I've said, the manufacturers we're using are capable of being commercial manufacturers. It's making the drug with the commercial process. So we're, you know, we'll be ready to make registration batches when that time comes. What is the estimated timeframe as to Neuren submitting all the required info to FDA on primary endpoints, and how long will it take for them to respond? I think it's the same question that we've already answered. Thanks for the update. It's greatly appreciated. Can I just confirm if the previous $50-$100 million guide is in U.S. dollars or Australian dollars? That's U.S. dollars. I've always said US dollars. How many patients will be in the Phelan-McDermid Syndrome trial? Talked about that. Do the sites all have to be in the U.S.A.? Liza, you've touched on this. Do you wanna just make a brief comment about that? Sure. So currently, we're identifying sites in the United States. But obviously, we are open to potentially exploring other sites, in the future, depending on the need. Thank you. How long will it take to manufacture the drug for phase III trial? So I've talked about that a lot, maybe the extra thing I'll say is, you know, currently manufacturing is not on the critical path. You know, we're gonna be comfortably ready to start the trial. This is an interesting question: Does the meeting with the FDA materially change your view on the future of the company? Look, it greatly increases my confidence. As I said in my opening remarks, you know, we were taking a pretty aggressive approach here in an area where there's been nothing, and for either us or the agency. So I'm actually really, really pleased with the outcome and feel very positive about the future and about the strategy that we've laid out. I think, I think we're in a very good position to execute it. Is it reasonable to expect the outcome from FDA on primary endpoints by the end of the calendar year? So, you know, Liza has talked about this. I, I personally hope that we may be able to do that, but, but we can't commit to that because, you know, it, it's dependent on the FDA coming back to us. Are you happy with how things are going, and how is your energy? Oh, dear, I must be looking a bit tired on here. Great job from us all, well done so far. So thanks for that. Yeah, as I said, I think... It's funny, when you go to these FDA meetings, you tend to be very excited, given how important they are, but you're also nervous because things can come from left field and often do, and it's just very important. So, as I said, we're really happy now to be past that, and have got such a good outcome. So yeah, I'm feeling good, and I think all the management team is as well, and, you know, we're incredibly motivated to execute what we've got in front of us. We've said before, once you deal with these patient communities, you know, you've got massive motivation to do something, and Phelan-McDermid Syndrome is no different. The team's had a lot of interaction there with the community, and FDA gets that as well, you know, so we've all got a lot of energy to get this done. Has any consideration been given to a share buyback or paying a dividend, however small, to bolster market interest and share price? So we talked about this before. We're constantly reviewing that. I've said before, I'm certainly not in favor of special one-off dividends. I've been involved in a situation like that before, which did not have a good outcome. I think it should come off the share price. I mean, that's what should happen. So that's a different thing to ongoing dividends, but you know, you need ongoing franking credits. We've got to recover the R&D tax incentive before we have franking credits. So again, we're not in a position to do that yet. So I think that leaves share buyback. We've certainly keeping that under consideration the whole time, and we'll continue to do so. so. Are you understanding a share buyback? Same question. I agree that sentiment for DAYBUE has shifted and weighed on the share price, even though the actual data is quite good. How do you shift the sentiment? So yeah, I mean, thanks for that question, and I agree with you. The outcome, you know, the run rate for sales more than $300 million per annum in such a short time is a fantastic outcome. But unfortunately, you know, expectations have been built hugely before that and have then been disappointed. I think the outcome is great. As for how we shift the sentiment, I don't think we can really. I think, you know, it's Acadia that can do that, and they can do that by execution and delivering, and you know, I have every confidence they'll do whatever they can to do that. Again, as I said, I don't want this to sound like it's a disappointing outcome. It's not. It's a great outcome. I think the further they get into the launch, the more experience they have, and I think you know the better indication about the future they can give. Is there any progress on other developments? I mean, I presume that's talking about new indications for NNZ-2591, which we've talked about, and I guess Pitt-Hopkins, we've talked about a little as well. Your net cash balance with continued flows coming in with no associated costs from Acadia is solid. It seems to me that even at $100 million for phase III PMS, your cash position is incredibly robust and doesn't seem to be an issue, increasingly so. My question is, would you consider a buyback at these levels? So yeah, again, absolutely, we would, and we are, and we'll continue to do so. And you're right, it's not just about the current cash balance. I mean, we have a lot of money coming in from DAYBUE. We're almost certain to earn the $250 million sales threshold milestone this year, which is a $50 million milestone payment, which we would receive in the first quarter of next year, which is another news item that I didn't touch on earlier in the other question. So absolutely, we've got a great position. Remember, though, you know, we've got Pitt-Hopkins, we want to execute. We've got potentially new indications as well. So it's not just about the phase III PMS cost, but absolutely we're, you know, considering buyback and we'll continue to do so. How long did Rett phase III recruitment take, and do you expect similar? So I've said before that, you know, start to result, so that takes in both recruitment and the twelve-week screening period for Rett, was about two years. Again, it's gonna depend on the number of patients we end up with, which depends on the endpoint outcome. But my current expectation is that I hope it will be something similar, and we'll update on that, in due course. Any plans on capital management if the endpoint agreement with FDA is favorable? So again, I've talked about that. I guess that does introduce an extra thing, though, that I'm saying I can't update on the detailed costs yet. Of course, that impacts the cost profile going forward, so there's no doubt that having that agreement with FDA would be an additional data point in our favor, but we're still considering it in the meantime anyway. Why couldn't the endpoints be agreed with at the meeting? Look, I hope you heard my context at the start here, that there's no precedent here, and there's no RSBQ, so and also, if you remember back to our results for this phase II trial, we had a lot of endpoints that were positive, so a lot of range of options, but most of them are not Phelan-McDermid Syndrome endpoints. So you've got this, that situation going into the meeting. So, there was a lot of discussion about a number of different options, and in the end, I think you know, we did reach provisional alignment on something, but FDA is not prepared to confirm that without supplying additional information. So again, I'd just say that if you're thinking back to the Rett experience, it was quite different. There was the Rett Syndrome Behavior Questionnaire that we'd used in the phase II trial, and we proposed to use in the phase III trial, and it was a Rett endpoint, so it was a quite different situation. But as I said, we've got a lot of endpoints that were positive in that phase II trial, which is a good position to be in. In fact, many more endpoints that are positive compared with Rett, where there were a very small number that were positive. What did Neuren propose for endpoints? Was it the same as the phase II? Again, as I've said, I'm not gonna go into specifics about the endpoints. All I will say is that, as I said, phase II had a lot of endpoints. If you go back and look at that announcement, you remember there were, I think, we had something like fourteen endpoints. I think you can, you know, it would be obvious that we're proposing something around that phase II endpoints, but I'm not gonna go into detail of what it was. Do you feel Neuren will be in a position to receive a priority review voucher for NNZ-2591 in PMS? So yes, I do, and we have the rare pediatric disease designation that you need. My understanding of the situation in the U.S. on the program is that the House of Representatives has passed the legislation that renews the program. It still needs to be passed by the Senate, so I think in the meantime, they've shifted the end date forward to December to give time for the Senate to ratify that. But I'm very confident the program's gonna continue, and that we should be able to get one, given we have the designation. Because of the very short notice given for this webinar, I missed the earlier part. Will you please place a recording of this, including Q&A on the website? So yes, we will, as we usually do. I'm sorry about the short notice. Unfortunately, that's we have to get the announcement out, and thought we should do the webinar this morning rather than this afternoon, so. But anyway, we will put a recording on the website. Completely different question here: Have you liaised with the new CEO of Acadia? So look, I haven't directly yet. We are liaising with lots of parts of Acadia and lots of parts of Neuren all the time. So we've certainly had dialogue on things with various people since the change of CEO. I haven't spoken with the new CEO yet, which doesn't surprise me at all. She's, you know, she's got a huge amount on her plate internally, and that's where I'd expect her to be focusing. I expect I will speak with her in due course, but I haven't yet. Similar question. On this recent trip to the U.S., did you meet the new Acadia CEO? I actually wasn't in the U.S. when that change happened. I was in the U.S. prior to that. When will Acadia monetize their priority review voucher, and is the market value still approximately $100 million? On the market value, well, the latest one that was sold a few weeks ago sold for $150 million. That's quite different to the previous five that were $100 million. So difficult to know whether that's a shift in value or an outlier. I don't know when they will monetize it. It's always said it's completely up to them. They may have been waiting for this, the legislation thing to play out in the U.S., but I don't have any control over the timing. All I'll say is, you know, we still consider it effectively a receivable for us. It's not on our balance sheet, but it's effectively a receivable for us, one-third of the value whenever they do realize it. Okay, and in fact, of course, we've got a few questions now about the new CEO at Acadia. Change in CEO at Acadia seems to have depressed their share price recently. Are investors worried that the quarterly sales up to September will not meet the previous optimism? Did you meet with Acadia and the new CEO during your recent U.S. visit? So there's a few things in there I've already answered about me meeting with the new CEO. Did have a meeting with other people from Acadia, but of course, that was before the CEO change. Are investors worried? I presume you mean Acadia investors are... I don't know that. I don't think so. I don't hear that, but I don't know that. And as for the change in CEO depressing the share price, I mean, their share price is up and down by those sort of amounts all the time, so I don't think you can necessarily draw that conclusion. I think, you know, the new CEO's got a great profile and particularly a very strong commercial profile, so I would expect her to be, you know, laser-focused on making the most out of DAYBUE. Do you think the new CEO of Acadia is a driver to develop their NNZ-2591 rights? Funny enough, I've just said she's got a great, a very strong commercial profile, and I expect her to be laser-focused on DAYBUE. I still think that'll be the number one priority. I don't know whether she will change any of their views about NNZ-2591. We'll see. Any thoughts on the rising short interest on the register? Thanks again. So, look, having short, you know, shares sold short, unfortunately, is just a common feature of being in the ASX 200. I don't think the amount of short sales is anything unusual compared with other, you know, ASX 200 companies. So I don't think it's a cause for concern. I'd rather it wasn't there, but I don't see it as a cause for concern. Can you indicate just how the lab trials for other diseases are going? When will the results be given? I'm certainly, I'm sorry, I can't give you any interim comments about any data. I've already talked about, I'm hoping we'll have something by the end of the year or early next year. Did Neuren apply for breakthrough therapy? I'm not gonna answer that. I'd have to be announcing that if I was answering that, so sorry, I'm not gonna answer that. What is the long-term strategy for Neuren? Do we have a vision to become a big pharma? Oh, look, you know, to become a big, big pharma, you know, what I've said is the huge value opportunity here is phase III for 2591, right? So the question is, how much of that do you want to capture? Do you want to capture it all, or the majority of it, or do you want to capture a small slice of it and let someone else take over now? That's what I've talked about in the past, and I've said for us, with all the experience we've got now and all the cash that we've got, that I think capturing most of the value is the best outcome for shareholders. I still believe that. Now, that doesn't necessarily mean you're gonna become a big pharma. I mean, there's another step beyond that, which is commercializing the drug. That's a much bigger step. You know, for us, going from phase II trials to a small phase III trial is a pretty small step, and we're very confident about our ability to execute that. But becoming a commercial company that's gonna sell a product is a whole different ballgame. That would be a complete change to the company and probably a shift to the U.S. to do that. So that's not currently our strategy, but it is an option in the future. If, you know, if shareholders wanted that option, that's an option in the future that you can make during phase III, you know, a decision you can make during phase III if you want to. I think for now, you know, as I said, the strategy is to make as much value as we can out of NNZ-2591 for shareholders, at the same time delivering it to patients. And while we're doing that, we're gonna be completely open the whole time to discussions with other companies about partnerships of whatever form, if they can deliver the sort of value that we're gonna get from that phase III uplift. Question: I hear that Acadia will want to launch a phase II, III in Rett within NNZ-2591. Is that likely? I don't know where you've heard that. I haven't heard that from anyone who'd know that. You know, it's like I can't say anything about NNZ-2591 in Rett until and unless Acadia do. I'm sorry, you're gonna have to wait for them to talk about that. Sorry, we're up to 45 minutes, so we'll finish very soon. There's a couple of questions left. Why is our share price so undervalued compared to market analyst reports? So I've already given my view earlier on. I think sentiment on DAYBUE is what has caused it to be where it is today. And interestingly, you know, the market analyst valuations have not really shifted much. They came down a little bit with that sales guidance change, but not much, which just shows, I think, that the impact on the share price is way overdone compared to the impact on the fundamental value of the company. But I feel it's a sentiment and a momentum thing, and I think it can shift, and it can shift quickly when it does. If we are focusing on orphan indications for NNZ-2591, why did we seek a patent on autism? Don't disagree with the move, but just curious as to the rationale. So look, you always want the best intellectual property coverage you can have on all your products, and of course, you know, if someone was seeking to use NNZ-2591 on autism, then it's important to have a patent that means that you protect that. If we were ever going to branch out of orphan indications in the future, then, you know, autism is an interesting one, albeit a very challenging one. But mainly it's just making sure you have the best patent coverage you can for your drug. Last question: Do you ever read the HotCopper threads? Yes, I do. You know, I'm interested to see feedback from shareholders, whoever they are and whatever it comes from. So I do, and I don't obsess over it, but I do read them, and there's often some useful information in them, so. Okay, we've finally reached. No, we haven't finally reached the end. Another one being added on. Right, this is the last one. We're gonna call it time after this. Is there any effort being put in to improve the digestion of the drug? Ah, so I'm guessing this is about DAYBUE because with NNZ-2591, we haven't talked about that this morning, but you remember from all the results from all the trials, there are no GI side effects appearing here. It's very different to DAYBUE, so you don't have that issue with NNZ-2591. If you're talking about DAYBUE, then again, you know, that's it's Acadia, it's not us. It's up to them. I'm sure they're doing everything they possibly can to improve the profile of the drug. I can't say any more on that. So finally, we reached the end. So thanks for sticking with us, if you all have. So that's longer than I meant to run, but I tried to answer all the questions. Thanks to everyone who's participated and for everyone joining again. I'd just reiterate, we're really pleased and very challenging meeting. We've got some work to do to nail down this final bit. We're looking forward to that, and then we can get into the trial, so thanks very much. See you next time.