Neuren Pharmaceuticals Limited (ASX:NEU)
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AGM 2026

May 27, 2026

Summary

Strong financial growth driven by DAYBUE royalties and expanding U.S. market presence was highlighted, with strategic focus on advancing NNZ-2591 clinical trials and exploring new indications. Dividend policy and capital management remain under review, while regulatory and market challenges were openly discussed.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Good afternoon, everybody. My name is Patrick Davies. I'm the Non-Executive Chair of Neuren Pharmaceuticals. It's my pleasure to welcome you to Neuren's Annual Shareholders Meeting. I know we have a quorum, and I therefore declare the meeting open. Before we proceed with the meeting, I have a couple of quick housekeeping matters. I'd appreciate if you could pop your mobile phones to silent. Recording devices and cameras must not be used during the meeting. In the event of an emergency, please follow the emergency exit signs and instructions of the venue staff. We are pleased to facilitate a hybrid meeting through MUFG Corporate Markets' online platform, enabling shareholders to participate from anywhere in the world, and I extend a warm welcome to those of you joining us online. The agenda for the meeting will be as follows. First, I'll present my address.

This will be followed by a presentation from our CEO and Managing Director, Jon Pilcher, who will provide a review of Neuren's activities. We will proceed with the formal business of the meeting, including consideration of the resolutions. Following the conclusion of the meeting, I'll invite those shareholders here in person to join the Board and Senior Management for light refreshments. Please don't go in a rush. We've got food for 50 or more. Joining me here today are my fellow Non-Executive Directors. Perhaps just raise your hand. Jenny Harry, Dianne Angus, and Joe Basile. No need for you to raise your hand, Joe. Also present are our CEO and Managing Director, Jon Pilcher, and CFO and Company Secretary, Lauren Frazer. Where's Lauren? She's hiding in the back. Good on you, Lauren. In addition, joining us online from Auckland is Diane Alamar, representing Neuren's auditor from Grant Thornton.

Our purpose at Neuren remains unchanged. We are focusing on developing medicines for children suffering from rare and serious neurological disabilities that have no or very limited treatment options. This purpose is extremely motivating for all of us at Neuren and is the foundation upon which we strive to build outstanding long-term value for shareholders. The period since our last shareholder meeting has been highly productive, and I'm pleased to report that your company is in a strong position, both financially and strategically, as we execute our plans for the future. In an environment of volatile financial markets, international conflicts, and uncertain economic outlook, we are in the enviable position of having a very strong balance sheet and a substantial income-generating asset in DAYBUE, with further expansion anticipated.

This means we can fund our highly prospective development pipeline for NNZ-2591 and consider further corporate and product growth opportunities to build shareholder value. For the year ended 31 December 2025, Neuren generated royalty income of AUD 65 million, up 15% on the prior year, and recorded profit after tax of AUD 30 million. Cash and short-term investments at year-end increased to AUD 296 million from AUD 222 million 12 months earlier, and net cash from operating activities reached AUD 125 million. These are impressive numbers that reflect the commercial success of DAYBUE in its early stage of life. Since DAYBUE was launched in April 2023, Neuren's cumulative income from licensing with Acadia Pharmaceuticals has now reached AUD 525 million. To have achieved this in just three years is a testament to the clinical value of DAYBUE and to the quality of our partnership with Acadia.

It is an outstanding success by any measure. Acadia has done an excellent job in driving the commercial performance of DAYBUE, with net sales of $391 million in 2025, representing growth of 12% over the prior year. In the fourth quarter, more than 1,000 patients received DAYBUE shipments, the highest level since launch. Pleasingly, the momentum of 2025 has carried into 2026. Earlier this month, Acadia reported DAYBUE net sales for the first quarter of 2026 of $101 million, up 20% from Q1 2025. Neuren's Q1 royalty income of $10.4 million was 23% up on the same period last year. Acadia also reaffirmed its full-year 2026 DAYBUE net sales guidance of $460 million-$490 million, which would represent year-on-year growth of between 17% and 25%.

For Neuren, this implies full-year 2026 royalty income of $50 million-$54 million, or approximately AUD 70 million-AUD 77 million, assuming an exchange rate of AUD 0.70-AUD 0.72. A particularly important recent development is Acadia's launch of DAYBUE STIX , the powder formulation of trofinetide, which was released to the U.S. market on a limited basis during Q1 2026, focusing initially on Rett syndrome centers of excellence. More than 250 prescriptions were written in Q1 2026, with around 30% of these for new patients or those who had previously discontinued the liquid formulation. Caregiver satisfaction exceeds 80%, and healthcare professional endorsement has been strong. The broader rollout of DAYBUE STIX began in early April 2026, and we look forward to monitoring its impact in the coming quarters.

We believe that there remains meaningful growth potential in the U.S., with penetration rates currently around 60% at centers of excellence and approximately 28% in the broader community. The opportunity for DAYBUE extends beyond the U.S. Acadia's named patient supply programs are providing a growing contribution to revenue as patients in other markets receive access to trofinetide. In Japan, Acadia's small clinical trial to support a marketing authorization application has accelerated, with top-line results now anticipated in the September to November 2026 timeframe. Japan represents an important and sizable market, and we look forward to news of further progress as it comes to hand. In Europe, the re-examination process for trofinetide is anticipated to conclude in late June 2026.

The last 12 months has been a period of substantial progress in the development of NNZ-2591. The most important part of that value creation is the phase III development program in Phelan-McDermid syndrome. The commencement of the KOALA phase III clinical trial was a pivotal milestone for Neuren. This was the culmination of many months of diligent preparation, including interactions with the FDA. The alignment achieved at two meetings with the FDA means we can have confidence that a positive result in the KOALA trial should enable us to prepare a New Drug Application. In parallel with executing the trial, we are completing all the other studies and supply chain activities that are needed to support an application, as well as initiatives to increase the diagnosis rate. Today, we have seven trial sites activated and enrolling, with 14 more nearing activation.

At the first two sites, nine patients have been randomized, two of which have already completed the trial. More than 80 families have been referred to the trial sites, and the new sites also have their own rosters of patients. We are very encouraged by the support from the PMS community and look forward to building further enrollment momentum through the rest of the year. We are proud to be the presenting sponsor of the PMS Foundation Family Conference in Colorado in two months' time, which will be a timely opportunity to engage further with the community. It is worth reminding ourselves that this is the first-ever phase III trial for a product to treat PMS. There is no precedent to follow, which means we are navigating a challenging path to success.

This provides the opportunity to be potentially the first treatment to address a significant and urgent unmet need. This was the same challenge and opportunity we faced with Rett syndrome, and that successful process has given us the ability to do it again, but this time retain much more value by executing phase III. We are truly on our way now and full of anticipation. Beyond PMS, we are prioritizing pursuing indications for NNZ-2591, in which we have the potential to be first to market and maximize the impact for patients and shareholders. In 2025, the treatment of the consequences of brain injury at birth, known as HIE, was added to PMS and Pitt-Hopkins syndrome as the highest value priorities.

Our interactions with the FDA for HIE and Pitt-Hopkins are continuing. In the second half of 2026, we expect to file the IND application for HIE and meet with the FDA to negotiate an executable plan for Pitt-Hopkins, which we intend to initiate next year. Two months ago, we announced and commenced another share buyback program, given our view that the company's valuation falls well short of the strength of our assets and outlook. This is based on our own models and those of eight broker research analysts who formally cover Neuren.

We are currently reassessing capital management options in light of evolving information, including the projected growth in royalties from DAYBUE and DAYBUE STIX, the potential for further milestone payments, the amount and timing of expenditure on HIE, Pitt-Hopkins, and potential new opportunities, our available pool of franking credits, and the impact of the substantial tax changes announced in the Australian federal budget two weeks ago. Capital management options include a continued buyback program and commencing franked dividends. Our goal remains to deliver shareholder value in a sustainable and responsible manner. We will confirm the outcome of the assessment when we report our half-year results in August, and in the meantime, we have decided to pause the buyback. The Board and management of Neuren are working diligently to deliver the potential that is in front of us.

The DAYBUE franchise continues to grow, with DAYBUE STIX already making a difference in the United States. The KOALA phase III trial is enrolling and advancing towards what could potentially be a first-ever treatment for PMS and a transformative inflection point for Neuren and our shareholders. This is a dynamic time at Neuren. We are building something our shareholders can be proud of, an ASX biotech company that is making a real difference to children and families worldwide while creating substantial and enduring value for our investors. On behalf of the Board, I thank every shareholder for your support. I also extend my sincere thanks to the management and all staff of Neuren who are so committed to our purpose. I am now very pleased to invite Jon Pilcher to make his presentation.

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Thank you very much, Patrick. I'm going to reiterate some of what Patrick said there and expand on some of it. Before I do, let me just add my thanks first to all of you in the room. Fantastic to see so many of you here. Thanks for coming. Also thanks to everyone who's joining us online. Also add my huge thanks to the Neuren team for everything that they have achieved. Particular thanks for today to Lauren Frazer and to the MUFG registry team who've organized everything for today. Thank you very much. As usual, before I start, just point out there's going to be some forward-looking statements in what I say and some of the slides subject to risks that could lead to different outcomes.

Okay, let's start by just reiterating the strategy of what we're trying to do here, which has not changed. I've said for a long time, and I still firmly believe this, that I think as an investor you can have the best of both worlds with Neuren. We have this cash generation business that has given us AUD 293 million of cash because we've had AUD 525 million of revenue from DAYBUE since it launched. I'll talk in a minute about the ongoing revenue that we're expecting to receive from that. That's an incredibly strong base to the business. That would be good enough on its own really, but that's not all that you've got here. The other thing is a participation in what could be a much bigger step up in value if we can execute on our plans for NNZ-2591.

We've been trying to do that. That's been the strategy for a number of years now. Normally, if you've got a follow-on product that you're investing in, there'd be a whole new set of risks and you're probably facing multiple capital raises diluting you to get there, and it may well be that a binary result that could have serious impact on most of the value of the company. I mean, that's often what you face in biotech if you're investing in these sort of products. I think we're in the privileged position where you're not facing that because you've got the backstop of value that is there with DAYBUE. You don't face any capital raises to get there. I think we have another advantage here that NNZ-2591 is so similar to trofinetide. I mean, they're biologically similar. Phelan-McDermid syndrome, very similar to Rett syndrome.

The way you develop it, very similar. The manufacturing, very similar. This has not got a typical risk profile of a second product. It's so closely related, and we are putting everything we've learned from the journey for DAYBUE and trying to do it again with NNZ-2591, which I think puts us in an incredibly strong position. The last thing I'll say, just Patrick mentioned this, there's lots of different indications as you know that we've looked at for NNZ-2591. What we are prioritizing really again is trying to do Rett syndrome again. It's indications where we can be first to market and make a big difference to these communities. We think that's the best thing for both shareholders and patients rather than going into indications where we'd have to invest a lot of money and potentially face a lot of competition.

We don't think that's a good investment for shareholders. That's why we've prioritized the indications that we've had. The most important thing about NNZ-2591 really that everyone should be focusing on is Phelan-McDermid syndrome, because that first phase III result is the thing that's going to really unlock the value for 2591 more broadly. I'm going to talk about DAYBUE and then NNZ-2591 obviously. Let's start with DAYBUE. Just a quick revisit of the economics from the Acadia agreement. I already mentioned the money we've received to date, and in fact it's a bit more than that because we had a couple of payments before it launched in 2023. Let's focus on the future cash flows that should come to us. On the left-hand side of the slide there is North America.

If you look down the bottom on the royalties, at the moment we're getting some royalties at 10%, some at 12%. Once sales get above AUD 500 million in a year, we start getting 14% on the amount above AUD 500 million. Next to that sales milestone, we already had the first one. The next one to come will be $50 million when sales in North America exceed $500 million in a year. We'll talk about where sales are at the moment and how that might look in a minute. There's another double the size of that, $100 million we would get if sales can hit $750 million in North America. That's very exciting and really the U.S. is the main game here. Again, we'll talk more about that in a second.

On the right-hand side of the slide, we have outside North America. Remember we received $100 million upfront from Acadia for that deal. Japan, in the recent quarterly update, Acadia accelerated the timeline for the small trial they're having to run in Japan, expecting results September to November this year. If successful, they file a New Drug Application next year. We'll get $15 million on the first commercial sale in Japan. Royalties between mid-teens and low 20%. I think you all know that in Europe, Acadia received a rejection from the European authorities, and it's now in a re-examination process, which is running according to the regimented timetable. Should reach conclusion at the CHMP meeting at the end of June.

If it were to be overturned, which, as you all know, I firmly think it should be, but precedent is probably against us. If it does get overturned, $35 million would come to us on the first commercial sale as well as the royalties, obviously. Let's look at the sales performance so far. These charts show everything up to the last year and then the guidance for 2026. Acadia's recent Q1 update, which hopefully a lot of you will have tuned into. $101 million for Q1 was the sales number. 20% growth on Q1 last year, and that's the highest year-on-year growth for some time. Really strong quarter, and they reiterated the guidance for the year between $460 million- $490 million, which will be 18%-25% growth. This is great. We're now three years into the launch and still growing strongly.

Then the royalty outcome for us is on the right-hand side. We had $42 million last year, and we would get between $50 million and $54 million of royalty, remembering that it's 100% profit to us, straight to pre-tax profit. That's a fantastic outcome, but I want to mention one more number that Acadia put out there. You might recall back in January, they gave an aspirational target for 2028 of at least $700 million of sales for DAYBUE, and they reiterated that at the Q1 update. Again, just strong growth expected from here on. A big factor in that is DAYBUE STIX. I'll talk more about it in detail in a second. Remember in the first quarter, there was a limited launch of DAYBUE STIX, the new powder formulation of trofinetide.

It was launched only in Centers of Excellence. The reason for that was because it was actually approved by FDA based on bioequivalence, not based on use in patients. No patient had ever had it before. Acadia wanted to have a limited launch in the Centers of Excellence where the physicians know everything about DAYBUE and about Rett syndrome. They thought that was the right thing to do before going more broadly. Early April saw the broad launch throughout the country of that. Quick reminder on what DAYBUE STIX is. You'll remember the original DAYBUE product is a bottle of liquid, and you measure out your dose from the bottle of liquid. Has to be refrigerated. It's obviously got a set flavor, a set volume. The beauty of DAYBUE STIX is a number of things.

It's sachets of powder that can be dissolved in pretty much anything other than dairy. Parents, if they have kids who like a particular taste or are able to tolerate a particular volume, they can do that with this now, whereas they couldn't before. Doesn't require refrigeration, obviously very portable as sachets of powder. Again, that's a great thing if families are traveling. It's a big step forward. There's less sugar in it, which is important to some families, not to others, but it is important to some. No dye or preservative, which again, is important to some families. I think Acadia, when they launched, saw this as a lever here to generate interest from two particular constituencies. Families who had not tried treatment yet, they might've been concerned about something to do with the liquid dose.

They'd started treatment on the liquid, but they discontinued. They saw this as an opportunity to really engage a lot of additional families, which wasn't possible with the liquid. With Stix in the picture now, we as Neuren really think there's very significant upside remaining in the U.S. If you look at that chart in the bottom left of the slide there. The penetration rate into these two segments of the market. The Centers of Excellence and then the broader community outside the Centers of Excellence. 60% in the COEs, but only 28% outside them. You might recall that Acadia last year increased the size of their sales force to get better coverage in that market outside the COEs, because you can see by the size of the charts here, actually two-thirds of the patients are outside the COEs.

You've got 28% of 2/3 of the patients. We really think there's a big opportunity here. I think the COEs can still grow beyond that, but a big opportunity to close the gap between the non-COEs and the COEs. DAYBUE STIX is going to play a big role in that. In Q1, in that limited launch, 250 prescriptions, and 30% of them were from either new families new to treatment, or families recommencing treatment where they'd stopped on the liquid. That's about 75 of those 250. That's a great start. It also shows you there's quite a lot of switching from the liquids. I'm sure that will be a feature going forward as well. Really encouraging to see those treatment-naive and discontinued patients coming on. Acadia did a survey about caregiver satisfaction.

More than 80% of caregivers were very satisfied with STIX. We're really excited to see now from Q2 onwards what might be the impact of STIX going forward to both those bars on the chart on the left-hand side to increase both of them. Maybe continue to see the persistency rate increasing. At the moment, it's about 55% long-term persistency, which means you're losing about 45% of the patients ultimately, which sounds a lot. Now, with chronic treatments, you often get people don't continue in the long term. Remember with DAYBUE, there is with the liquid, there is a common GI side effect which plays a role in that.

We've been saying for some time, a patient starting today has got a much better chance than that of staying on in the long term because of all that's been learned about how to deal with that side effect profile. Now we're hopeful STIX might play a role in that as well. That 55% has gone up over the last few quarters, and we think that can go up further. The final thing is, the number of Rett syndrome patients is still growing. You can still get a growing population, a growing percentage of them starting treatment, and hopefully a growing percentage of them persisting in the long term. We're very excited still about the U.S. It remains the main game.

Really, I know there's been a lot of fixation on the European situation, but really for me, everyone's eyes should be on the U.S. and STIX performance. That's the key thing for DAYBUE. Okay. Let me now move to that second big value uplift that I talked about with NNZ-2591, and obviously, we'll start off with the most important thing, which is Phelan-McDermid syndrome. I said we're trying to do a trofinetide and Rett again, and it really is very similar. Critical part of it is working hand in hand with the patient advocacy organization. There are two here, Phelan-McDermid Syndrome Foundation and CureSHANK that we're working very closely with. We have all the designations that expect from FDA in orphan drug, rare pediatric disease, Fast Track. Rare pediatric disease gives us eligibility to receive a priority review voucher if we get marketing approval.

They've saw a few more have sold recently between AUD 150 million and AUD 200 million. Remember, this time we don't get a third of it, we have the lot. That's a very valuable asset that we potentially have there. Very importantly, we've painstakingly through two meetings with the FDA, got alignment that if we execute the trial, and I'm going to talk about in a minute, that should be sufficient to file a New Drug Application. It was really important as a first indication to have that alignment with FDA. The final thing I'll mention is that, even though this is doing Rett and trofinetide again, it's not quite the same in that if those of you who've been with us for a long time will remember that we did two quite big phase II trials in Rett before Acadia did the phase III trial.

There was another company had done, at least partially done a phase III trial in Rett. The Rett community was much more trial savvy than the Phelan-McDermid community, which is fine, but it just means we've more heavy lifting to get them ready for what we're now into, and I'm going to cover in a minute. It wasn't quite the same thing as the Rett situation. We had more heavy lifting to get the community up to where it needs to be. KOALA that is now underway, and I'll give you some the latest on that in a second. Let's just remind ourselves what KOALA is. The first ever phase III trial in PMS. We did a phase II trial in only four sites, right? This is a phase III trial in 20 sites. It's a big step up.

From a risk point of view, obviously, I talked about this being lower risk because of the connection to trofinetide. We want the highest possible chance of success, obviously. We've tried to design that into this trial. As much as possible, there's a similarity with the phase II trial. It's the same age range, the same length of treatment, and the same dose as we had in phase II. We've kept the trial in the U.S. We're going to have at least one site, maybe two in Canada, but really it's kept in the U.S. The more you go into other jurisdictions in clinical trials, the more variability you introduce, the more risk you introduce. We've kept it as it was with Rett in the U.S. Of course, from a funding point of view, this is fully funded from our existing cash.

The way the trial works is there's a four-week screening period to make sure the kids are eligible and the right kids are coming into the trial. They're randomized onto either drug or placebo. They spend 13 weeks on that, then they're able to all continue on with treatment for 12 months with the drug. The other important thing from a risk point of view for this trial is the endpoints, again, back to our phase II trial. We've got to hit two co-primary endpoints as we did with Rett, they were both very robustly positive in our phase II trial. One of them is the physician score of how the child has improved over those 13 weeks, the other one is a caregiver measure, specifically on communication, again, of how they've changed over those 13 weeks.

Now, in our phase II trial, in both cases, 16 out of 18 kids improved. The level of improvement, the physician one is the same as one of the endpoints we had in Rett, and the result is much stronger. It's much better score than we got in the Rett trials. On the communication caregiver measure, we saw, again, 16 out of 18 improved, but 25% average improvement from baseline. We feel we've got, again, a good position here from a risk point of view that very robust results in that phase II trial on the endpoints that matter. We also saw a good safety profile in that phase II trial, and no sign of GI side effects. We've thought all along that's a differentiating feature of NNZ-2591 compared with trofinetide, which is very important.

Let's bring you up to date, and Patrick gave these numbers in his speech, but I will reiterate them. On the slide here, we've got a map of our sites. The dark green, if you can see that, are sites that are activated. The light green pins are ones that we'll activate soon. I think as Patrick said, we've got seven activated, 14 to activate soon. More than 80 families referred to the sites. What that means is that families have come to us wanting to participate. We're then referring them to sites. Actually, the new sites that have recently activated have got their own long list of patients. One of them has a list of patients up to 50, and they're not even in the 80. We feel we're in a good position now.

Three of the sites who've opened recently are really important sites. They're probably the most well-known key opinion leaders in Phelan-McDermid syndrome that we've worked very closely with. Fantastic to have those three sites open as we speak. Patient-wise, the patients who've been in the trial to date are all from those first two sites. Nine of them randomized. Two of them have already completed those first two sites. Expect those first two sites to have more, but a lot of those 80 families who have referred are going to be going to the other sites along with their own lists of patients. We've also received approval from the regulatory authority in Canada to have sites in Canada. We've got one there you can see on the map due to open soon, and there may be another one opening down the track.

Then the open-label extension study that was on that trial schematic, that started as well. We're in a good position. Patrick mentioned that family conference, the Phelan-McDermid Syndrome Foundation Family Conference. In Denver, Colorado, in the third week of July. I'm heading there along with a number of the Neuren team. We're the presenting sponsor, anything you see about the conference as presented by Neuren Pharmaceuticals underneath it, we'll be there en masse. Great opportunity to really rev the community up and get their support, we're hoping to have most of these sites open by then. Perfect timing, we think, to really get some momentum off the back of that conference. Very much looking forward to that. I tell you, it's incredibly humbling always to interact with the families.

Done it for many years in Rett syndrome. Now in Phelan-McDermid Syndrome Foundation, we're going to meet a lot of families, a lot of kids at that conference. That surely drives home why we're doing what we're doing, and makes us all highly motivated to get the right result for these families, which will give the right result for shareholders as well. Okay. Let me just turn briefly to the other priority indications, so HIE and Pitt-Hopkins syndrome. I'll recap and then just give a quick comment on the latest position. You might recall, a few months ago, we had interactions with FDA on both of these. You'll remember me complaining at the time that they weren't interactive meetings. They were written responses, which was not helpful given the subject that we needed to discuss on both of them.

These are tough programs, again, that no one's ever done anything before, and certainly with Rett and with PMS, we've had interactive engagement with FDA, which has been really important, and we didn't get that this time, I think, given the resource constraints at FDA. With both of them, we're going to need another interaction, and we need to absolutely make sure that it's interactive this time. Quickly on HIE, you recall that they required us to do another animal study in juvenile animals before we can dose the very young kids that we have to dose in HIE. Which we were disappointed they required us to do that. We've prepared to do it. They did ask us to review the protocol before we start to make sure that if we execute that study, it's what they want. We're waiting for that feedback now.

We've submitted it to them. We're waiting for it. We're ready to start as soon as we get their feedback. It's a three-month study, and then we would file the IND to be able to start that first safety study. We'll obviously let you know when that happens, but we're expecting to file the IND in the second half of this year. We need another interaction with them about then the long term on HIE. That hasn't been set yet, but the most important thing is to get the IND open, get that clearance from them. Pitt-Hopkins, different situation. With that one, you remember we've done a phase II trial, which gave some very encouraging results, and we had a meeting with FDA where we proposed what we thought could be a study to support registration.

A smaller study than PMS with different endpoint proposal. They didn't allow that. They basically told us to do the same thing as we're doing with PMS, to have those two co-primary endpoints and similar endpoints. The problem with that is that the Pitt Hopkins kids are much more severely impaired than the Phelan-McDermid syndrome kids. The sort of endpoint the FDA is wanting us to pair with our CGI, it doesn't show enough sensitivity in those severely impaired kids. That means you've got to have more of them to get statistical significance in the result. If we were going to do what they've suggested we do, we'd have a trial in Pitt Hopkins of more than 200 patients, probably a lot more than 200 patients. That's just not feasible to execute that in the population of this rareness.

We don't think that's the right thing for shareholders' money. If we're going to put in the same sort of costs or even more than we're putting into PMS, it's just not the right investment to make. We think this population deserves something that can be a registration study. We're going back to FDA with trying to give them what they're looking for from an endpoint point of view, find a way to drive that sample size down to something that's executable. We're looking at the comparator. Does it have to be placebo? The way you analyze the endpoints, there could be different ways of getting a result with a lower number of patients. That meeting's not set yet. We're just finalizing the details of that. It'll be in the second half of the year.

That means we're not going to be able to start that study, which if we get clearance from them, we won't be able to start it until early next year. Again, I know some people are disappointed in the length of time it's taking to take the next step with Pitt-Hopkins syndrome. Again, from a shareholder point of view, it would be the wrong thing to do, and we'd be foolish to just go and do what FDA has told us to do and try and do the same thing we're doing with PMS. That would not be a good investment to make, and not good for the patient population either. You want to have a real decent chance of success to put these families through what is an incredibly onerous trial, however it's designed.

We're putting our best foot forward, and we desperately want to do something in this indication. We think it's a great opportunity, and the community very badly needs it. We're going to need FDA to weigh in a little bit there, and we'll need to have some interactive dialogue with them for that. Just a quick reminder, the numbers of patients we're talking about here. In this table, the U.S. gives you the theoretical number of patients in the U.S. from prevalence data. The comparator there, as you remember, the Rett syndrome, the theoretical prevalence is about 6,000- 9,000. PMS, we've always said 2x-3x Rett in theory. Pitt Hopkins is a little bit smaller than Rett. HIE is a little different because you get, sadly, recurring patients every year, about 6,000 patients happening every year.

It's a different set of patients. Important to understand, we're not at this stage envisaging the HIE treatment is going to be a chronic treatment for life. Again, that's something we've got to discuss with FDA. Our base case is perhaps it will be a year's treatment. You'll be basically treating 6,000 one year, you'll be treating a different 6,000 the next year, and a different 6,000 the next year. That makes it like Rett, except that we think if this could be standard of care, then you could get a much bigger penetration into that number, again, if we're successful.

Mentioning standard of care, that's something I forgot to mention on Rett, and I want to just come back to it because one of the things that's happened recently is a publication with KOLs in the U.S. saying that DAYBUE now is part of the standard of care for Rett syndrome. The reason that's important is the outside, the centers of excellence, getting them onto treatment. The physicians are much less familiar with the product, that's why Acadia increased the sales force, to get more information out to these physicians. Having a publication that shows that standard of care is an important component of that. Sorry, I meant to say that earlier. Nearly done.

Before I conclude, I wanted to just bring this up because you hear lots from me, but you don't really hear from the people who are doing all the work here, which is our executive team reporting into me. These are very important people. On the row at the bottom there are all in Australia, and the row at the top are in the U.S. Gerry and Lauren are in the room here. You might get a chance to talk to them later. I want to just give a quick mention of the others here, very important players in our mission here and what we're trying to do with PMS in particular. Liza Squires now has been with us for four years as Chief Medical Officer, and she came in envisaging what we were going to be doing with NNZ-2591.

She's a highly experienced Pediatric Neurologist, so right in our specialty, but also with huge years of experience in drug development and in rare disease. An important one of those names underneath her picture there is Shire. Shire don't exist anymore. They were taken over by Takeda a few years ago. Certainly, in my career, they were one of the poster children of rare disease drug development, and Liza spent a long time there. Larry Glass, many of you will know, been here even longer than me, in fact, a lot longer than me. Knows everything there is to know about our two drugs and weighs in on strategy really across the Board. Then Daryl. Daryl DeKarske, really important addition to the management team in the last year. Daryl, you'll see under his picture, you'll see Shire appear again.

Yes, he's worked with Liza in the past, with Shire, which is great. He ran the regulatory function at Acadia, was instrumental both in our original deal with Acadia and then the phase III development and the New Drug Application for DAYBUE, all of which was successful, of course. Daryl brings that knowledge to us. We were absolutely delighted when he joined us, and is big step up for us from a regulatory point of view. Clive Blower, he has been at Neuren very similar time to me. I'm 13 years, he's 12 years. He has led all aspects of CMC, so manufacturing, everything to do with manufacturing. Remember that we don't manufacture ourselves, it's all third parties, but it's a complex supply chain. He's led all of that for both trofinetide up until the point we handed it to Acadia, and now NNZ-2591.

Here's a perfect example of us learning from, benefiting from hindsight and learning from trofinetide. He's been able to put all of that to bear in the NNZ-2591 program. Yeah, really important people, all of these. I just wanted to acknowledge them and talk a little bit about them. Right. I now am going to finish. Final slide, I just want to reiterate that I really think out of all the ASX biotech companies, I do think we're in a unique position, which I think is great for shareholders, and remember, I'm a shareholder. Sustainable growing royalty income from DAYBUE. We've got that strong momentum in the U.S., and STIX starting to play a role in that now. That's supplemented by very significant one-off milestone payments. We've been through what they might be.

There's the opportunity to unlock that big value of NNZ-2591 through successful execution of the PMS phase III trial, and I've talked about how we've tried to maximize the probability of success there. That DAYBUE commercial model is attractive because it's 100% margin, so straight to pre-tax profit for us, so huge financial leverage from it. We have the ex-U.S. upside optionality. Talked about Japan, with the results coming late this year, leading to then a New Drug Application. Obviously, there's the wild card of the European Union re-examination at the end of June. I think, the base case, if you look at precedents in history is that it won't get up.

I still firmly believe the right decision would be for it to get up, and I desperately hope that'll happen, but I think that is upside to us and certainly not in our share price. The final thing, as I said, we've got this pipeline that's fully funded. Not only that, we've got surplus cash, and Patrick's talked about that, opportunities to enhance shareholder value in a number of different ways. I think, fantastic position to be in. It's the same story as it's been for a long time, and we're all still highly motivated to get the outcome that we've been chasing for a long time. It's getting closer. Thanks very much. I'll finish there.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Thanks very much, Jon. We'll now proceed to the formal business of the meeting. I'll take the Notice of Meeting, including explanatory memorandum as read. Before moving to the resolutions to be considered today, I'll briefly outline procedures for the meeting. Please note that only shareholders, proxy holders, or shareholder company representatives are entitled to speak or vote at this meeting. Voting on the resolutions will be conducted by way of a poll. The results of the poll for each resolution will be released to the ASX following the meeting. For those attending the meeting in person, you may cast your vote by completing a paper voting card. If you have questions, please see a MUFG Corporate Markets team member at the registration desk outside this room.

For those shareholders participating in the meeting via the online platform, you can cast your direct vote using the electronic voting card received when online registration is validated. Please refer to the virtual Annual Meeting online portal guide or use the helpline if you require assistance. Following the formal business, we will take general business questions. If you're attending the meeting in person, you would have received an attendance card upon registration. If you have a yellow voting card, you are a voting shareholder, proxy holder, or corporate representative, and have chosen to vote using a paper voting card. You are also entitled to speak at this meeting. If you have a blue card, you are a non-voting shareholder. While you are entitled to ask questions and make comments, you are not entitled to vote at this meeting.

If you have a red card, you are a visitor, and you are not entitled to speak or vote at this meeting. If you hold a yellow or blue card and wish to speak, please raise your hand at the appropriate time, identify yourself to me before asking your question using the roving microphone. For those joining via our online platform, you will be able to submit questions by registering as a shareholder or proxy holder and clicking on the Ask Question tab. You will have the opportunity to submit an online question or a verbal question by selecting the web phone facility. Please follow the prompts or refer to the online guide for instructions. I encourage shareholders who have questions to send their questions through as soon as possible. I will address the questions submitted online and by web phone after taking questions from the floor.

First item of business is to receive and consider the annual report for the year ended 31 December 2025. The annual report is not to be accepted, rejected, or modified in any way. This item of business does not require a resolution to be put to the meeting. I'll now open this item for discussion. Would anyone like to address any questions to the company or to Diane Alamar, the representative of Grant Thornton? Anyone in the room? Doesn't seem to be the case. Are there any questions on the phone?

Lauren Frazer
CFO and Company Secretary, Neuren Pharmaceuticals

There are no questions on the phone line at this time.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Thank you. Are there any questions online? There are no questions online. We will now move to the resolutions of the meeting. Valid proxy votes have been received, representing approximately 46% of the company's issued share capital. The proxy votes received are shown on the slides. We can pop those up in a moment. Shareholders participating online will have the opportunity to ask questions on each resolution via the virtual Got to click a button? Leave it to the boss. Okay. Just before we get to Resolution 1, as outlined earlier, I intend to call a poll on each of the resolutions. Resolutions 1, 2, and 3 set out in the Notice of Meeting are ordinary resolutions, as such, must be approved by a simple majority of the votes cast by shareholders entitled to vote and voting on the resolution.

Resolution Number 4 is a special resolution, to be passed, requires the approval of 75% or more of the valid votes cast on the resolution by the shareholders entitled to vote and voting on the resolution. Resolution 1 concerns the re-election of Joe Basile as a Director. Joe has served as a Non-Executive Director since March 2023 and is Chair of the Audit Committee. I now move that Joe Basile be re-elected as a Director of the company. Firstly, are there any questions from the floor? There are none. Are there any questions on the phone?

Lauren Frazer
CFO and Company Secretary, Neuren Pharmaceuticals

There are no questions on the phone line at this time.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Are there any questions online? There are no questions online. Thank you. Please now select either for, against, or abstain for Resolution 1 on the voting card. Resolution Number 2. In accordance with Section 207S of the New Zealand Companies Act 1993, Resolution 2 seeks authorization for the Board of Directors to fix the fees and expenses of the company's auditor. I now move that the Board of Directors is authorized to fix the auditor's fees and expenses. Firstly, are there any questions from the floor? There are none. Are there any questions on the phone?

Lauren Frazer
CFO and Company Secretary, Neuren Pharmaceuticals

There are no questions on the phone line at this time.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Thank you. We do have a question online. The question is that Grant Thornton has been our external auditor for many years with a market capitalization of AUD 1.82 billion. Isn't it time we move to a Big Four auditor? When was the last external audit competitively tendered, and when is it next to be tendered? Do we have a policy on audit firm rotation and frequency of tendering, and if not, why not? Firstly, I don't know that a Big Four audit firm would be of any greater value than Grant Thornton. I'm not trying to promote Grant Thornton here, I can tell you they don't give us an easy run. They were the guys that insisted we move to U.S. functional currency reporting, which I'm not sure we needed to do. Anyway, we don't have a formal policy on rotation of audit for tender.

I think it's something we can take away and consider. We're confident that Grant Thornton rotate their partners and change their staff from time to time, so I'm confident we get a good, clean, and challenging audit each year. Are there any other questions online? I don't think on this matter there are. Thank you. If you would now please select either for, against, or abstain for Resolution two on the voting card. Resolution 3 concerns shareholder approval in accordance with ASX listing rule 10.14 to grant 360,000 unquoted options to acquire ordinary shares to Managing Director Jon Pilcher. I now move that for the purposes of listing rule 10.14, approval is given for the company to issue 360,000 unquoted options to acquire ordinary shares to Managing Director Jon Pilcher. Firstly, are there any questions from the floor? There are none.

Are there any questions? I'm sorry, is there a question from the floor? No. Scratching is no. It's like an auction. It's okay. Are there any questions on the phone?

Lauren Frazer
CFO and Company Secretary, Neuren Pharmaceuticals

There are no questions on the phone line at this time.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Thank you. We do have a question online. It's got a bit of a familiar theme, this one. The first sentence is deliberately written to inflame our friend Trevor Scott. New Zealand is regarded by some as a governance backwater. It continues to resist mandating annual voting on REM reports, which is standard in many countries, including Australia, the U.K., and the U.S. Given our head office is in Camberwell and we hold our AGMs in Australia, why don't we voluntarily put up a remuneration resolution for an advisory vote at the AGM? Will you do that next year? There was a 13.5% proxy vote on the proposed CEO LTI grant, or protest vote, I should say, on the CEO LTI grant, which proxy advisors recommended against. What was the issue? Maybe I'll start with the last one first.

It's not necessarily clear that the proxy advisors voted no. The proxy votes cover everybody who's voted prior to the meeting. Proxy advisors are used by many professional investment firms, and we have seen a number of proxy advisor reports. I won't state who they were and what they all said, but one of them did vote or recommend to vote against the issue of options to Jon. I think their logic was deeply flawed, and I'm glad it has no consequence for the ultimate outcome, and it wasn't adopted universally, it would appear, in any regard. They, for the record, felt that the hurdles for the options for Jon, which are the same for the other executives issued options at the same time, did not reflect what is more commonly seen in options schemes for other Australian-listed companies of our size.

I don't think comparing a biotech company to an industrial company is a good idea. I think the outcomes are quite different and driven by quite different events. The hurdles for Jon and the executives are not financial hurdles. It's not get sales dollars of X or achieve market share in percentage terms of XYZ. They are definitely linked to shareholder value. They're only valuable if the share price is up. They are of no value if the share price goes down. They are value creation milestones that have to be achieved, and that is fundamentally different to a more mature, large revenue-generating company that is perhaps a more predictable entity than we have. There was also a question about why they vested on change of control, and why could they vest earlier than three years? All of which, again, I think is misguided in our case.

I'm happy to say that the plan we have in place, I think is the right one for the executives and for the company. That's the background to perhaps some of that protest vote. The topic's come up before about creating a REM report and putting it to a vote. I'm happy to take it as something we can consider. I don't think it adds any value whatsoever. I think it's just work for the sake of it, so that you know what Liza Squires is paid in great detail is of no value to any shareholder, in my opinion. I think it just sets her up to be poached by another company. Same for our other senior executives. It's not a big company. We're trying to keep it as simple as we can and get on with things that matter.

I take the point, and the Board will have a look at that again during the year. I don't think there are any other online questions on this topic. I would ask you now, please, to select either For, Against, or Abstain for Resolution 3 on the voting card. Resolution 4 seeks shareholder approval for the amendments to the company's constitution, as set out in the appendix to the Notice of Meeting, with those amendments to take effect from the close of the meeting. The proposed amendments to the constitution reflect a number of developments in law, the ASX listing rules, corporate governance principles, and general corporate and commercial practice for ASX-listed entities since the constitution was last amended in 2016. I now move that the amendments to the company's constitution be approved. Firstly, are there any questions from the floor? There are none.

Are there any questions on the phone?

Lauren Frazer
CFO and Company Secretary, Neuren Pharmaceuticals

There are no questions on the phone line at this time.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Thank you. We do have a question online, which basically says, without reading it all, that, again, which proxy advisors have recommended against the proposed changes, and how hard did we lobby for this? Did we consider pulling the resolution because it needs 75% to pass? On the numbers that you can see, unless we have a flurry of votes in favor of it cast now or up until five minutes after the close of the meeting, the resolution will not pass. We're attuned to all of these issues. We took a considered decision to let the motion run, not to pull the resolution, which we could have done. I think that would have been weak and to me, not really justified. We put this forward in good faith. There's still a chance this resolution will pass.

A couple of shareholders had indicated they would vote online during the meeting, and let's see if they do. If they do not, this matter will come back to the meeting next year. It is, in my opinion, entirely non-controversial. It's housekeeping. The one topic that a proxy advisor did raise is concern that the Managing Director is not put up for re-election by rotation every three years. Which is not an ASX listing requirement. Again, is seen by some people as an important thing to do. Again, I don't think that has any real consequence for the company whatsoever. We would love to get these through. We're not trying to do anything silly here. We're just tidying up the house. It's utterly boring. Nobody really wants to talk about it, but we want to get it done.

If it doesn't happen today, you'll see it again next year, but we will look more closely to see if there's a better way to get that through. We'll have to wait till after the meeting. Are there any other questions online for this one, Lauren? No, there are not. Thank you. Please now select for, against, or abstain for Resolution 4 on the voting card. It's now time for any general business questions. Are there any questions from the floor? We have one here from [Peter].

Speaker 7

Yeah. Thanks, Patrick. I notice that we're talking about dividends and?

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Use the mic. You're not in the mic.

Speaker 7

Oh, sorry. Okay. Thank you. Yeah, we're talking about dividends. I can't understand why we kicked the can down the road for another three months. I noticed the share price is down. Well, it was down AUD 1.50 just before, now it's down AUD 1. I was just wondering why we can't make a decision now? That's question number one. Question number two, why in God's name did we defer the buyback? As soon as these shorters know the buybacks are not relevant, they'll play with the share price, and that's exactly what's happened this afternoon? They're my two questions to all.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Well, deferring the buyback while we're contemplating entering into a franked dividend stream, which if you read the language is, and particularly with the changes to the federal budget, is a likely outcome, it's not guaranteed, is to us seems to be a strange thing to do. To continue with the buyback if you're likely to move into a dividend. We're not too far away from the announcement, and typically, we're not alone on this, I think this is standard behavior. Companies would declare a dividend after their half year and full year results. We're not talking at this stage about a special dividend, a one-off dividend. We're talking about introducing, or debating introducing a dividend that continues.

A one-off dividend on the 27th of May compared to doing it with the half year and then full year results going forward is, I think, very familiar territory for most companies.

Speaker 7

Patrick, I would have thought that if you'd know exactly where the figures are, 11 months are already gone in the financial year. It wouldn't take long to work out how much you're going to earn for the year, so I can't understand why you're not doing it now?

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

As noted, Peter, we've got a new dynamic with DAYBUE STIX that is one month, not even, into the last announcement that Acadia gave, and we will have by August at least another quarter for those sales. I think that gives us the perfect basis to make a proper decision. Are there any other questions from the floor? There's one over here, Gerry.

Alf Sarrow
Shareholder, Private Investor

My name's [Alf Sarrow]. I'm a Shareholder. I've got a question about the E.U. application, and I know that this is a small part of the big picture, but it's a significant part of the picture. What have we done to make this second go at the application different, in order to boost our chances of getting it across the line? Anything different, or are we just putting in the paperwork yet again? No.

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Thanks. The first thing to understand that it's not us, it's Acadia. We don't have any control over that. It's Acadia's application, so they are the ones going through the re-examination process. They have huge skin in the game to get a different outcome. They've invested in commercial infrastructure in Germany to be ready to launch the drug, and they've paid us $100 million for the rights in the first place. They've got massive skin in the game to, if they can, turn it around. The way the process works is you can't introduce new data. You can't suddenly bring in data from another trial or anything. You can introduce new interpretations, and you can introduce new viewpoints, and that might be from the Rett community, for example.

One thing that was obvious from the European thing they put out was that they don't understand the clinical meaningfulness of these scores. You've got to somehow bring that to life by what actually happened with the patients rather than what scores did they get. That's the sort of thing you can introduce some of because it's not new data. That's the sort of thing Acadia will be doing. Again, it's not us, and we don't have any right to participate in that. We are relying on Acadia. As I said, they have got massive skin in the game to get the right outcome if it's possible.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Are there other questions from the floor?

Ian Wescott
Shareholder, Private Investor

Jon, you mentioned Pitt. [Ian Wescott]. Pitt Hopkins is maybe becoming a little questionable. If it doesn't come to fruition, we've now dropped Angelman or put Angelman on the shelf and maybe Pitt Hopkins. Do we have any strong candidates that we can announce that we would replace these?

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Yes. It's not just Angelman. Of course, we've got Prader-Willi and SYNGAP1 as well, and that's okay. At the moment, we've chosen not to prioritize those. If Pitt-Hopkins was t o not be executable, we may well look at those indications again. Things are moving all the time. With Angelman, the reason we haven't moved forward with it is there are two companies running phase III trials in Angelman. One of them is going to read out during the second half of the year. That data's going to be very instructive, the strength of that data as to whether we should move forward in that. SYNGAP1 is one that we haven't pushed forward yet, so that could be a possibility as well.

Speaker 8

Hi, my name's [Anthony]. It seems like things are accelerating with respect to the PMS trial. Are you happy with the rate of acceleration in the last month or so in terms of the sites and the families that have put their names down? The second question is, does that impact on the timetable for final readouts and things like that? I think you've mentioned a couple of years using the DAYBUE one. Is that likely to be changed given the rate of acceleration in terms of the sites and that?

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

I think that's still our best benchmark to have. We're still not far enough in to be able to say anything different to that. We will, at some point, turn that into formal guidance, but I think that's the best benchmark for everyone. As for what I feel about it, I think there's a lag between sites opening and then patients coming in, going through screening, and then randomizing. What we have got now is movement on the sites, and I'm happy with how the first two sites have done from a patient point of view, and I think we can get real building momentum from here on with these new sites. As I mentioned, some of them have got huge lists of patients themselves, never mind the ones that are being referred. And I'm very happy with the commitment and excitement in the community.

Yeah, we feel good about it. We haven't got to the point where you're seeing the patient numbers yet, but that will come.

Speaker 8

The families that were involved in the phase II trials, what percentage of those have expressed interest?

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Yeah. That's a really good question, and I meant to mention that in my address, thanks for bringing it up. Because that phase II trial was open label, you're not allowed to then participate in a placebo-controlled trial because the parents know they were on drug. What we are doing is, provided they meet the eligibility criteria, they're going to be able to participate in the open-label extension part of the phase III program. Certainly really looking forward to some of those kids getting back on treatment. They're not there yet because they need the right sites to be open, but certainly one site is now open that is one of the phase II sites that will enable those phase II patients to get into the study.

James Isgrim
Shareholder, Private Investor

My name's [James Isgrim]. I'm a relatively small Shareholder, but I noticed one of the reasons for not handing out some of the franking credits, the Australian franking credits, was it wouldn't be fair to the New Zealand shareholders. Well, what's the significance of the New Zealand franking credits to our franking credits?

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Look, I don't think if it was talked about not being fair, that's not what was said. I don't know whether that's been misinterpreted. It just means they can't benefit from them. Obviously you've got to frank the dividend, so there's franking credits on the whole dividend, but the New Zealand holders won't be able to benefit from them, so they'll be wasted. Which doesn't mean you shouldn't do it, because the rest can be used. Yes. It was just pointing out that not all shareholders will benefit. That's all. That's not why we're not doing it, obviously. That's not having any bearing at all on the decision.

James Isgrim
Shareholder, Private Investor

It's listed as a reason.

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Listed where?

James Isgrim
Shareholder, Private Investor

In the documents that got sent.

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Okay.

James Isgrim
Shareholder, Private Investor

One of the reasons for not considering Australian was that it wouldn't be fair to the New Zealand shareholders.

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Okay. I haven't seen that. We are considering it. We're not considering. We are, as you've seen, considering it. That won't be part of the consideration at all.

Speaker 9

Hey, Jon. Yes. My name's [Sean]. I just wanted to ask a question about the costs for the PMS trial. Are they tracking as you would have expected?

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Yes, they are. You recall we said $80 million-$90 million was the range. At the time we said that, some things were fixed, but quite a lot of things were not fixed yet. Yes, we're still in that range. Yeah, still happy with that.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

We have one online. We have one other over there, Gerry.

Speaker 10

You're thinking about franking credits and things like that. What about acquisitions that would add to the pipeline and things like that?

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

We get approached often, and we think often about what else we could do. We would not do anything to damage the growth opportunities that are in front of us. We're not looking at anything that would require a major capital raise or something that would compromise what's in front of us. Yes, we do look at, and I think it's in all of our best interests to do that, but there's nothing to share at this point on that. We do have a question online, and I'll just read it out. The NNZ-2591 development continues to delay. PMS is very slowly progressing. What progress has been made since the last FDA meeting in December 25 relating to Pitt-Hopkins syndrome in particular, and HIE?

The CEO address is forecasting CY 2027 start time for phase III, which is nearly three years since the phase II results were announced. This is not a good reflection on management's capability. I think maybe you can recap what you said previously.

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Yes, I think I've sort of answered some of that in my presentation. The only thing I would say is if FDA had agreed to what we'd proposed in both cases, we would be about to start both of them. The reason it's taken longer is because FDA hasn't agreed to it. If you want to criticize our handling of the FDA, that might be fair enough, although it's very difficult at the moment with what's going on at the FDA. Still, we just think you've got to do the right thing in the end for both shareholders and patients. There's no point in rushing and wasting money on the wrong thing and putting families through something that's flawed. Frustrating as it is, I think it's certainly better to wait and do the right thing ultimately.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Are there any other questions online?

Speaker 11

Yeah, Patrick.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Oh, sorry. Yes.

Speaker 11

Quick one. In the announcement, well, that you just ran through before, you mentioned about the budget changes and substantive changes. Obviously, there are substantive changes to all us as shareholders, but what's the effect to Neuren? Why does that come into a capital allocation discussion for Neuren?

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Well, it's only if people value more highly now a frank dividend than they did before. Just a comparison, whether we will see more interest in companies that have, for Australian investors, some form of frank dividend. That's the relevant point. Yes, the question at the back.

Speaker 12

Just a quick one. I don't expect a succinct answer. I am healthcare-based, and I've been a holder of Neuren since 2015 and sort of had many discussions with Jon over those years. Do we have sort of any prognosis of an accelerating timeline to be able to offer anything to Australian families and Australian patients in any of these conditions? I understand obviously launches and stuff have to be done overseas for population bases and regulatory. Even with named patient and stuff. I've referred quite a number of families directly to Jon over the years from my practice, who have very, very highly with his personal response to each of them. Are we sort of any than we were several years ago from actually being able to offer them a treatment in Australian shores?

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Yeah, this is a very difficult one. I don't feel good about answering it. With trofinetide, it's entirely in Acadia's hands. Again, we have no control or influence over that. They are running named patient programs internationally. There are families in South America, the Middle East, and Europe who are receiving treatment. Those programs are paid-for programs. It's not compassionate use. There has to be some sort of ability for it to be paid for in Australia, and that, unfortunately, is a big problem despite our wealth as a country, is we're not great at funding new drugs. Trofinetide I think is out of our hands, although I'd love to see it here. NNZ-2591 obviously is in our hands. At the moment, all we're doing is focusing on the trials to get it approved.

I guess it will depend whether we then remain in control of that or whether that moves with someone else as to whether it will come here. I'd love to think it could come here. Yeah, it's a bit of a watch this space for NNZ-2591. I might add New Zealand to that as well, given these drugs came out of New Zealand, so I should add them to that.

Speaker 9

Jon, there's a question that continually comes up in my mind is, when would Neuren look at possibly taking more seriously offers to buy the company out? When I was originally invested in it, I was told that this business was being built to be sold at some point. I'm not sure if that was correct, but that was the impression I was put under at different times?

Jon Pilcher
CEO and Managing Director, Neuren Pharmaceuticals

Yeah, well, I'm happy to, but.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Any offer will be taken very seriously.

Speaker 9

Yes.

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Of course, we would update shareholders at the right point. The company is open. There's nobody on the Board saying, we don't want to hear about an approach from a company. I can assure you of that, Sean. Yeah.

Speaker 9

Are you getting any approaches, or is there anything ever been put on the table?

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

We can't talk about things unless it's at a point where we can share it with you, so I'm sorry, I can't answer that.

Speaker 13

Hey, Patrick. Do you think the Neuren team has enough share expertise dealing with I've heard a lot about momentum trading, and it's very erratic at the moment. Do you think their team has enough knowledge to stop that and try and manage the share price a bit better?

Patrick Davies
Non-Executive Chair, Neuren Pharmaceuticals

Not quite sure how best to answer it. We don't rely only on ourselves for this. We do have external advisors who are much more au fait with these matters, investment bank in particular, Jefferies Group. We do have some people that are spending a lot of time on investor relations. Could we do it differently? Could we do it better? Perhaps, in truth. I doubt there'd be many companies that say, we've got this covered. We know exactly what to do every day of the week. I take the point. We can talk a bit further about that, but we're not doing it all on our own. Any other questions? Okay, thank you. That concludes the formal business of the meeting. Our shareholders participating via the virtual meeting website should now have submitted their votes.

If you are intending to vote, you will be able to finalize and submit votes up until five minutes after the meeting ends. The results will be announced to the ASX after the conclusion of the meeting. I now declare the meeting closed. Thanks for your participation today.