Neurizon Therapeutics Limited (NUZ) Earnings Call Transcript & Summary

We are recording this important conversation today as Neurizon enters an important phase of its development. Enrollment platform trial. Top line results are expected in Q2 2027 and Dr. Chris Bremer has joined the company as Chief Executive Officer. Welcome, Chris.

Thank you.

Today, we'll get to know Chris and discuss the broader Horizon story. We'll look at the science, the clinical program. We'll look at manufacturing and regulatory bounties global partnerships, leadership capability and strategic opportunities that have been built around NUZ-001.

So Chris, I might turn to you first. For people meeting you for the first time, what shaped your career in biotechnology, and what attracted you to Neurizon at this particular point in its development?

I don't want to bore you with too much detail, but I think what a good summary of my career is it was always the part of translation of science to commercial. And a big part of that career was more on the commercial side, but they always wanted a leader who understands the science well. And then in the second part, they really positioned me in that gap of science and commercial where you need to get late-stage clinical trials right to translate it into the best value for patients and also for shareholders. And to be honest, many times, it's the same thing because we need to reach as many patients as possible and that then automatically translates to value. And to be honest, I've always very much enjoyed that part. I'm a physician, I like the science, but I like having an impact. And especially at Neurizon, you asked about my motivation. To be able to have a positive impact for these patients or people living with ALS is very rewarding. And even though there's still a few milestones ahead, I think that potential is a strong motivation for me.

Sounds like the passion is there. I might turn to Serg. From a Board perspective Serg, what were you looking for in a new CEO?

[indiscernible] Well, most mature boards have in place a succession plan. So we're always looking ahead strategically. That includes the role of the CEO. It includes the capability that exists on the Board and the capability of the team because in Life Sciences and Biotech, your skills that you need, the things that you focus on evolve. So the Board did have quite a robust succession plan in terms of what we think we need in the future. So when the former CEO resigned early in March of 2026, we executed that plan. And what we were looking for very much actually some -- I could summarize going back to what Chris discussed about his own experience, his passion, his focus. We're looking at a CEO that had a couple of really core attributes. Number one, they could connect and lead our team. It's an incredibly good team, very passionate, very tight net understands what needs to be done and has a history of really good execution. So we wanted a CEO who would come in and understand the value of that team and enhance it. Two, we are looking for an individual that had that was a clinician that would always help connect with the patient centricity of what we're trying to do with our therapeutic experience in generating value from a clinical asset, either in a number of transactional sense. So someone who has a track record of understanding the science, being able to translate the science into value through multiple ways, not being tied to a particular process. And the other was a person that had international experience. So our therapeutic is likely to be commercialized, it should be successful in the U.S. first, but it has a global marketplace. So someone who has worked in multiple markets who understands the nuance of various markets connected to capital markets, connected to partners, that's what we're looking for. And I have to say it was a really tough choice, Chris, although an easy one in the end, I should say. We did interview many. The process ended for about four months. And I know some were saying, why are you spending so much time, but we thought it was critical that we got it right, and we believe we have got it right.

Dan, as a key member of the team, what were you looking for in a leader?

I might start actually by giving Serg a bit of a compliment and when he stepped into the he did a terrific job of establishing a great leadership team, empowering and giving clarity so we could focus on getting our jobs done and deliver. And I think over the period, it was leading us, we certainly delivered on a number of issues. So first of all, thank you to Serg and the acknowledgment of the great work he did. But as a starting point, I think the leadership team was looking for someone like Serg would empower -- would allow us to support and deliver and do our jobs would also be additive in their own right, fill some of the gaps that we had, particularly as we look forward beyond the HEALEY trial into the potential to commercialize that was a real gap for us. So look, I think we were looking for someone who would allow us to keep working the way we've been working, would be additive, but perhaps more importantly, could communicate well with the team, lead the team with some clear priorities, great judgment, good experience. And I think we kind of got everything that we were looking for in Chris added to which I think I personally was looking for someone I'd be happy to have a beer with and hang around with and have a bit of fun with. I think we've got that in Chris as well.

Excellent. So we might take ...

Can I jump in there? Just because -- I'm not just saying it just to say, I really feel it. Asked me about why I joined the team, why I joined Neurizon, from the beginning, this struck me as something very special, the team. I mean they're all very accomplished individuals, specialists in their field, but it was really them interesting as a team. And actually, one of the first interactions was with Dan and Martin, how they give each of the credit, they listen to each other that was very special. And from the beginning, I had this feeling that I would connect well with this team. And actually, I'm very proud to be a future part of that team.

Excellent.

Thanks, Chris.

And we're looking forward to getting your insights as well. So we might start with you. The [indiscernible] HEALEY readout naturally attracts attention. When you look at Neurizon as a whole, what gives the company value beyond the proximity of that single milestone?

There are many elements we could talk about, and I want to talk later about all the elements which are in place, which are for me, impressive for a company of the size of Neurizon. But looking a little bit further into the future, you also have to see there are line extensions lining up. There are new indications on the horizon. So I don't see this purely as a one drug company. There is more potential mid- and longer term. And I come from precision medicine where you look for -- to understand the disease and then you can properly position the product in that space, and that's where I see a lot of potential here.

Serg, if I can turn to you, which achievements most clearly show that Neurizon has moved from development preparation into global clinical execution?

I think there were a number, but I'll highlight the trial on the HEALEY ALS platform, so Regimen I. Being able, firstly, to -- firstly, being selected for participation on the platform trial to be able to raise the necessary funds for us to participate fully in both active and the active treatment extension phase of the trial to be able to fully recruit 250 participants in the time frame that we did. I mean that's also a credit, obviously, to the HEALEY network. That's a pretty big achievement for, I think, a small Australian biotech. And in many ways, I feel that we really do punch above our weight. I don't want to be tried about that. I think that we have achieved and are achieving a lot with the capital that we've got in the country that were residing. So there's a lot in that and those who understand Australian biotech would appreciate those truths. The other is the relationship we have developed with Elanco and the importance of that relationship across three dimensions of our business really. The first one, obviously, is the access to the Global Licensing Agreement that we -- which gives us access to really important data, and we can talk about that later, but that was fundamental to us getting our initial IND approved by the FDA, that body of data that we could leverage efficiently. I think that was -- that's an important element. They are now, I think, our #3 or fourth shareholder. They're on our register. They're a large global company, market cap of around $12 billion on the -- in the U.S., so they have on our edge to say something. We've got a Board observer, Dr. Steve Nanchen, that says something as well sitting on our Board. But finally and critically, when you talk about maybe the next phase around of execution, is the work that was done by Dan and others working with Elanco to finalize the manufacturing and supply agreement. I think that agreement, which we can talk about later, is another enabling agreement, which will fast track our ability to execute, should we get the results we're seeking from the trial in terms of the ability to scale up access to the active pharmaceutical ingredient API and then to generate the tablets that we need. So yes, look, they, I think, are the main ones that I would draw to in terms to say, "Hey, look, we're no longer an interesting scientific experiment. We're now a clinical development company, and we're actually now moving towards clinical execution of that asset.

Chris, I might turn back to you again. ALS is one diagnosis. It can progress very differently from one person to another. What does heterogeneity mean in ALS? And why does it make drug development challenging?

That's a very good question. Heterogeneity means that although the symptoms we see the decline really in motor function in these people living with ALS as a symptom looks the same, the underlying mechanisms can be very different. And you see different sites of unset you see different speeds of progression. And to me, coming again from precision medicine, that means the underlying mechanisms are probably not all identical, meaning they're heterogeneous. And this is what we have to understand. And for instance, biomarkers are one tool to understand that better. When biomarkers align with clinical outcomes, they are a very, very powerful tool, for instance, in discussions with regulators, the FDA, but they also help you to plan future trials much better selecting patients based on some characteristics. So Overall, I would say the success probability increases the better you understand these heterogeneous diseases.

Staying with you, Chris. NUZ-001 is designed to target impaired cellular [indiscernible] clearance pathways associated with neurodegenerative diseases. In plain language, what is the biological thesis? And how has that evidence base developed?

One central pathological mechanism in ALS is buildup of proteins, aggregates. They -- from clusters in the cell, think of it as a garbage accumulating. And with that, the cell becomes dysfunctional, needs more energy and ultimately die. And that's what we see. So this buildup of proteins as a central mechanism seems to be influenced by NUZ-001. We see that in preclinical experiments. We see indications of that also in the clinic, meaning that we prevent the buildup of these clusters, aggregates, the garbage in the cell. And with that, hope to also slow the disease.

Great. Serg, a positive clinical result creates lasting value if the company can move efficiently into the next stage. What has Neurizon already done on formulation, [indiscernible] and manufacturing readiness?

Okay. Look, there was a lot I can talk about there. I might actually also renewing Dan in relation to this. But firstly, and we're fortunate that the work that we've done to date with Elanco and our tableting supplier, Catalent has resulted in the therapeutic dose that we're using in the trial of NUZ-001 being in a very small tablet, 10 milligrams, and the dosing is 10 milligrams per kilogram in the trial. So that -- the size of the tablet is already such that it is readily digestible by patients with ALS. In addition, you can crush the tablet and so the tablet is crushable and can be mixed with food or other liquids, which actually also aids ingestion by person with ALS. The active pharmaceutical ingredient, the API, that is developed manufactured for us by Elanco has now moved to two human grade GMP grade, and that was the work that was done a lot with Steve Nanchen and that you're acutely across as well, Dan. So -- and that can be done at scale. And whilst that process isn't fully completed in terms of some of the validation batches, it's very well advanced. So in terms of being able to manufacture the API and then the [indiscernible] at scale, having a partner like or a relationship with Elanco, I should say, I think, really does actually fast track the commercialization. But Dan, I don't know if you just want to add something to that relationship.

Look, I think one of the reasons I've really enjoyed being at Neurizon is the fact that the Board and management have had this real strategic focus on what happens next, so you don't become the dog that catches the car and then kind of sit there and not know what to do with it, if you like. Yes. We've very much been thinking about how do we ready ourselves for a good top line readout. And then as a finance person, one of the things that I'd flag is that we've done it in an incredibly capital-efficient way, particularly through the support of the Elanco relationship. I mean if you look at the amount of work we would have had to do to generate the safety data that we're able to access through Elanco through our license agreement, which gives us an exclusive license to commercialize. But through that, we were able to use all their safety data, which cost tens of millions of dollars will cost us but basically nothing unless we're successful. Similarly with the supply agreement, their IP protected manufacturing process that can deliver high-quality ad volume active pharmaceutical ingredient monopental, not only that, but there are batches available ready for us to go, but we haven't had to bet the company on it. In the event they're not successful, they'll be absorbed back into the Elanco supply. So I think about the progress we've made and the readiness we've achieved through that relationship. And in fact, where we are for the amount of funding we've utilized. And I think you compare us to any other global in the same position than they would have spent, multiples of what we've spent.

So how should investors understand Horizon's regulatory position today? And what decisions would follow the top line readout, might throw to you again?

Yes. So we know the HEALEY platform trial is what we refer to as a Phase 2/3 potentially pivotal trial. And what that means is in the sequence, it's a Phase 2 trial, but it has all the characteristics of a Phase 3 trial. That means if it's positive, it can lead to a full regulatory approval in the U.S., and that's -- of course, the best case and best scenario. There are also other scenarios where that first approval is what they call an accelerated approval where the FDA expects to to still conduct a confirmatory trial afterwards. Plus there are then also other possibilities where you see signals in the trial or signals in subgroups which would allow you with additional trials, of course, achieve regulatory approval further down the road.

So I'll throw this question out to the table, Neurizon has built relationships across clinical research, government-funded access, manufacturing, scientific advice and the patient community. How does that network improve the company's ability to succeed?

I might kick it off. Well, the network that we have developed, the relationships which we've developed, which will explain in a minute. -- fundamental to our ability to commercialize and engage with at least our initial primary market in the U.S. So firstly, the relationship we have with Mass General Brigham Hospital, where the HEALEY ALS platform trial is run out of. It is their IND. They are running the trial, which is -- which I sort of like and we all like there's that degree of independence in terms of they're doing it. And to the protocol that's been approved by the FDA, they have an established network of that we're using 78 clinical sites in the U.S. to actually -- which actually enabled us to recruit very quickly. So that network of key opinion leaders, that network of neurologists, that network of specialists is fundamental to us being able to execute the actual trial. We've also got connections with patient groups and patient associations, they are also pivotal not only in spreading the awareness around the trial and the potential therapy but also in certain instances, they can actually help advocate for approval with the FDA. They have a strong voice. So that's -- there's some of the relationships, which I think are pivotal our ecosystem. Did you want to talk about the recent National Institute of Health approval for the extended access program? That's a...

Really importantly, not only are we in this imminent well-regarded trial through HEALEY, which gives us that engagement and awareness. But we've also just been approved or funded or a 200-patient expanded access protocol, which program, which allows us allows people suffering from ALS, who don't otherwise qualify for HEALEY to still have the benefit of this investigational therapy. So it will create great engagement with the ALS patient community and will also broaden the awareness of subscribers in the U.S. So these are all really important parts of us establishing ourselves again post readout.

Chris, did you have anything to add to that?

I'm very much looking forward to engage with patient organizations. I think they are extremely important. I want to understand what people with living with ALS, what their perspective is, what's important for them. So we can consider their view, but there -- they can also help us influence decisions. So I think that piece is important. And the rest, I would just repeat, I think I'm amazed at the strong partnerships we have built, that is with the HEALEY Consortium Harvard associated group. They built this trial, and they've selected Neurizon and NUZ-001 to be part of their regimens. So that's a strong endorsement. We have Elanco as a very reliable partner, and it helps us in a capital efficient way to scale up to GMP standard material. We have the NIH support for the EIP. So these are all very strong elements, and I'm impressed how the management so far has built these strong relationships which help us to progress.

Dan, I have a finance question. How has Neurizon aligned its financial strategy with the clinical, regulatory and manufacturing work needed around the readout?

One of the great things about working in Neurizon is a very engaged and supportive Board who understand the challenges and opportunities and how to make sure we both position ourselves well for the readout, but maintain flexibility and watch the market and always have an eye to what's in the best interest of our shareholders. So Yes, simple terms, we're funded through to top line readout. So great support from our shareholders, great support from our convertible note financier. And also critically with the recipient of nondilutive funding through the Australian R&D tax incentive, a really important part of our funding and critical both our development and the development of biotech companies in Australia, I think it's terrific. And so yes, I would say we're fully funded. We are well positioned to get the readout and then look forward into what the options are thereafter. And as we flagged, got a lot of the commercialization work ready to go, which gives us a lot of optionality around where to. So for some biotechs, they get to a readout and they need to partner up to be able to progress because they don't have manufacturing sorted. They don't have distribution sorted, as an alternative as we discussed, we're well positioned with Elanco around. The manufacturing of our API and tableting and perhaps more importantly, as we discussed around the AIP and HEALEY, will be great understanding in the prescribing community of our of our drug and how it's performed in various trials. So I think we're uniquely well positioned to have a lot of options in front of us, whether to partner or not might be one of those.

So if NUZ-001 produces supportive clinical evidence what strategic parts could become available to Neurizon, might throw to you Chris for that one.

Of course, there's the regulatory side, and I think we've touched on that before, for the U.S., but then we would also think obviously about other international geographies where we would obviously intend to register the product. But maybe I'll highlight the more commercial partnering sides. So of course, that is something we already looking at and would look at more closely to get a partner on board who has the same vision and can help us to run some of the future trials, which would be necessary in other geographies. And we would very obviously look also at opportunities to commercialize ourselves in some geographies, that's clearly an option. The U.S. is the obvious one. While I think it's clear that in some other geographies, Latin America, some smaller countries, we would very much look for a partner. And that's the work we need to be doing that. The second piece, I think, is then thinking about the signs, if results are positive, then we can think about additional indications. We mentioned [indiscernible], for instance, we can think about line extensions, combination products. So there are so many things in my mind that you can do. But obviously, that first critical milestone, yes, is the first critical element to advance all of these activities.

So Serg, what must Neurizon execute between now and top line results to be ready for several possible outcomes?

Well, the first step was obviously bringing Chris on board. We're all very excited about that. Clearly, we need to complete the clinical trial. So that path is underway, and that will play out. We'll get the data towards the end of Q2 2027, depending on what that data is, we have a number of strategic options. So the Board will be very much focused on understanding what the best strategic alternatives and options exist for our organization under various scenarios. -- that will be generated by working very closely with now an increasingly skilled management team. So I think the Board will be really focusing on strategic preparedness, and that is a very close relationship with the executive team. So I think we've got to get that right, understand what options we have. So as we know what we need to do when we start to get the data, and it starts to read out. Look, before then, there's a lot of work that continues. All the -- our partnering program continues. I mean, Dr. Martin Inglis not here today, he is an incredibly important part of our executive leadership team. He's been doing a lot of work together with Dan in the past and then in the future with yourself Chris, around engaging with our partners. There are many partners that are very interested in where we're at and what's to come. We need to continue those relationships. And in parallel, understand what it means for us to take this alone, should that be a strategic course that we decided to do. And the third and there's other alternatives clearly [indiscernible] plethora could be what would an M&A deal look like if that's possible as well. And being prepared for all those contingencies.

Chris, did you have anything to add to that?

Not much to add. I'm thinking about the partner perspective, and they will look at the same elements. They want to see a company that's prepared, that has all the elements in place. We mentioned the GMP supply, all the scientific support, preclinical experience, IP. And I see a company which has all that now, and we need to strengthen that to the extent possible. If we do that, then there is no magic to it and just continuous execution, which the team has shown to do very well yes.

So to close off, I'll get a view from each one of you. Do you think is the single most important thing you want shareholders and the ALS community to understand about Neurizon today?