Nyrada Inc. (NYR) Earnings Call Transcript

Good morning, good evening, wherever you may be. Welcome to the Nyrada Investor briefing webinar. My name is Dimitri Burshtein. With us -- I look after Investor Relations. With us is James Bonnar, our CEO. If we can just wait a moment just to make sure everyone's arrived. Just to let you know, this webinar will be recorded as I hit record. And it will be posted on our website if you'd like to watch it later. So just a moment before we kick off, please. One more person joining. Okay. Well, time to kick it off. Thank you again for -- welcome to the Nyrada Investor briefing for today. Thank you for joining. My name is Dimitri Burshtein. I look after Investor Relations. With us also is James Bonnar, our CEO. This webinar, as mentioned, is being recorded and will be posted on our YouTube page soon. The reason we're having this webinar is that it's been a fairly big year for Nyrada and a fairly big year to come. James will go into the details of that. It's been, as mentioned, a significant and transformational year. Before we move forward, just a couple of housekeeping things. Of course, we have to mention our -- the mandatory disclosures about the information here is not advice and be careful what you read. This slide deck has also been released to the market this morning, so it's available to review at your pleasure. I take also the opportunity to welcome -- we take the opportunity to welcome any new investors who've joined since our last webinar. And just to remind anyone online that we have an SPP that's currently open and will be closing on Monday next week. So please take the opportunity to have a look at the information booklet. Okay. I'll hand over to -- sorry, before we continue, this format -- the format for today is not going to be James running through a set of slides because they've been released to the market. What we're going to do is we're going to -- I'm going to ask James some of the most common questions we're asked. Hopefully, that will address any queries that you have. If there's any questions you have that haven't been addressed, please put them in the chat box, and we'll try to ask them during the presentation. We have to close this at 9:45. So with no further ado, I'll hand it over to James.

Yes. Thanks, Dimitri. And I just want to extend a personal welcome and thanks to everyone who's joining this webinar this morning. So as Dimitri said, this year has been a very busy period for the company, and we've had a lot of success. So I'll just start by running through the list of key achievements for the past 12 months. So back in February, we released data from a stroke study. This was a mouse model of ischemic stroke, where we saw an impressive efficacy result, a 42% neuroprotection. Second to that, we also released data more recently in October. This is a rat study that we ran looking at myocardial infarction or coronary heart attack in a rat. And we found that the drug also conveyed significant cardio protection. So we're going to talk about those results in a little bit more detail and lay out what the plans are for the next 12 months. The other significant advancement was the recent completion of a battery of safety and toxicology studies, and these were completed in rat and dog. And these are a comprehensive set of studies that are required to be run for a novel new drug before it can go into a first-in-human study. So we'll talk a little bit more about that as well. Also ongoing is a study that we're running in collaboration with the Walter Reed Army Institute of Research. This is a DoD or U.S. Department of Defense branch that specifically looks at traumatic brain injury. So we've had a long-standing collaboration with them. We've got results that are coming out in January. So we're happy to take some questions on that as well. The final achievement, I guess, is the advancement or imminent advancement of the drug NYR-BI03 into a first-in-human Phase I study. So we'll talk a little bit more about that as well and take any questions.

Thanks, James. So with no further ado, let me put the first question to you, James. What is the problem NYR-BI03 is looking to solve?

So NYR-BI03, our lead molecule, has been developed with a very specific role in mind. It's an ion channel blocker, and it's a drug that works on a novel target that's only fairly recently been studied. And we see it as a potential first-in-class treatment for stroke, for traumatic brain injury, or TBI, we'll refer it to, and also coronary heart attack. So all of these events are serious and life-threatening. And we're excited by this molecule, given the efficacy data we've seen in preclinical studies with it showing not only neuroprotection, but also cardio protection. So we'll talk a little bit more about how that works. The drug itself has been developed as an acute treatment, and it would be delivered to patients in an emergency setting by intravenous infusion. So in terms of the big picture opportunity, we see NYR-BI03 is representing a transformative solution for these critical medical conditions. And you'll see as we go through this that for some of these indications or events we're talking about, the current treatments are either limited or don't exist and certainly in the case of traumatic brain injury. So we're talking about very large, and we see them as underserved markets. And if you look at the slide that Dimitri shared there, there's the potential for up to USD 60 billion in market potential across these 3 indications. I guess just one final point and sort of just to summarize what's on the slide. We see this as 1 drug, 2 applications, 3 major markets.

The company has just raised $3.3 million in capital with an SPP currently running. What will this capital be used for? And how long will it last?

So the capital that we've just raised will take us through the Phase Ia. And we'll talk a little bit more about the Phase I study in a later slide. But that's a key first-in-human milestone to confirm safety and tolerability of the drug and also to determine pharmacokinetics, which is essentially drug levels in the blood following administration. The money that we've raised will also cover some R&D that we've got planned looking at other indications where this biological target, these TRPC ion channels are relevant. I'll talk a little bit more about that as well. Dimitri mentioned there's a share purchase plan that's open currently. We're looking to raise an additional AUD 1 million in that share purchase plan. And that will, I'm confident, take us into the second part of the Phase I. This is what we dose patients or subjects for longer.

What is the status of the Phase I trial, James?

So the Phase I trial is in the late planning stages. We're just assembling the documentation required to submit to the Human Research Ethics Committee. And so we're engaging with the site and a CRO, a contract research organization, to compile that documentation. And it's essentially distilling down what we learned in the safety and toxicology rat and dog studies and putting that into an investigator's brochure, which describes everything we know about the drug and also drafting a clinical study protocol. They're the main documents. And that's well advanced. We're looking to get the ethics committee application in imminently. And once that's approved, that will open the way for dosing the first cohort of patients. In terms of how long the Phase I study will run, we have, as you see in the graphic here, initially 3 cohorts. Each cohort we estimate will take approximately 1 month. The first part of the study is dosing with a short duration infusion, 3 hours. The second part of the study will be dosing up to 72 hours. So each of those cohorts will, we think, take approximately a month. So that takes us into the middle of calendar year 2025. And one thing we'll be doing as we work through the Phase I study is we'll be communicating the results of each cohort to the market in an announcement. Just in terms of the study design, this is a randomized placebo-controlled double-blind study. So what that means is that some of the subjects, and these are healthy volunteers we're talking about here, some of them will receive the drug and some of them will receive placebo. But the subjects and the study staff and indeed the staff at Nyrada, they won't be -- they won't know what treatment is assigned to what subject. So that's kind of where we are. In terms of the study itself and what it's designed to show, it's primarily a safety and tolerability study. So we'll see how the drug is tolerated by healthy volunteers. And it will enable us to pick a dose and a dose regimen for Phase II studies that will follow.

And speaking of Phase II, James, what might a Phase II study look like?

So a Phase II study, that's a study that's conducted in the target patient population. So we'll be studying the drug in either ischemic stroke, traumatic brain injury, or coronary heart attack. And these studies typically enroll, say, up to 100 patients. And with the cardio study, the coronary heart attack study, we're looking to run that here in Australia. Similarly, the stroke study. With the traumatic brain injury study, we would love to have some sites here in Australia, but we really need access to patients, and that drives recruitment rate and the duration of the study. So we see that as being a study that we would primarily focus in the U.S.

What is the study -- moving on back a little bit, what is the status of the Walter Reed study? And if you can just describe what it is, please?

So the Walter Reed study is a study of the drug in a model of traumatic brain injury. And it's in a model of traumatic brain injury that's specifically relevant or particularly relevant to the military. So in this study, we're looking at penetrating traumatic brain injury. So this is the sort of injury that you would sustain following, say, a bullet wound or a shrapnel wound. And it's obviously a high priority for the military for obvious reasons. We've done an extensive pilot work with this model. And we've just run the in-life phase of the drug study. And this is a collaboration with Walter Reed and also UNSW here in Sydney. And the samples have been scanned by MRI at UNSW, and the data analysis is ongoing. So as we said that the study is due to readout in January.

One of the key things for a drug development company, obviously, is patents and patent protection. What's the status of BI03's patent?

So NYR-BI03 is a novel molecule that our chemists have developed. And so we've lodged a patent -- provisional patent for that. And what that patent covers, it's called a composition of matter patent. So basically, it's protection of the molecule plus closely related analogs. And we've also included in that provisional patent, the indications that we intend to go after. So in terms of patent protection, the composition of matter patent offers a very high level of protection from other competitors. And it's preferable to say, a method of use patent or a formulation patent. The provisional patent will be published in 12 months' time. And it will give us, from the filing date, which was in October, 20 years of patent protection once granted. So that's a typical life of a patent for a drug. And in terms of the territories that we'll look to get coverage, the obvious one is the U.S. because it's such a huge market and also Europe and the countries that make up the EU, and Japan, but we're also looking to get protection in countries with large populations like India and China.

Non-dilutive funding is often an important source of funding capital for small biotechs. What's the opportunities before Nyrada?

Well, there are many and varied. With traumatic brain injury, there are non-dilutive funding opportunities available through the U.S. Department of Defense, and we keep a watching brief on those opportunities. And it's really a matter of timing for the right grant opportunity to come along at the right time. The DoD grants, they tend to cover not only preclinical development, but also clinical development as well. And we see ourselves as well placed given the long-standing collaboration we've had with Walter Reed. Outside of that, there are lots of other government programs, not only in the U.S. through the NIH, but also here in Australia through some of the governing bodies here. And just recently, for example, there was a Royal Commission report published, which made a recommendation to establish a brain injury program. So we're interested in that. And outside of that, the Department of Health also regularly publish grant opportunities that we hope to take advantage of.

James, just on that one, for those on the line who aren't aware, James had a -- well, I won't say a similar role, but came from Neuren where he helped develop their brain injury program and Neuren was successful in gaining some capital from the U.S. DoD. Obviously, some of your experiences will be -- could be a value to Nyrada on that.

Yes. So anyone who has invested in or follows Neuren will know of the drug, DAYBUE or trofinetide. Interestingly, that started out as a drug to treat traumatic brain injury. So I oversaw the traumatic brain injury program. And as Dimitri mentioned, that was funded in large part by the U.S. Department of Defense. So I've sort of been down this road before and looking forward to getting into the clinic.

And speaking of commercialized brain injury programs, how long do you think before NYR-BI03 may be commercially available? What's the clinical pathway for any of the indications you've indicated?

Yes. So the Phase I study that we're running has been designed to support Phase II in either stroke, traumatic brain injury, or coronary heart attack. Now the Phase I study, which I've talked a little bit about, that is anticipated or typically Phase I studies run over about a year. But drug development runs in 3 stages. And the second stage beyond testing the drug in healthy volunteers as we're about to do is Phase II. And Phase II studies are in the target patient population. They're typically larger in scope. And Phase II studies typically run over about 3 years, 3 to 4 years. Phase III, which is the final stage before approval, they tend to run over 3 to 5 years. But there are a number of things that drive the timing, particularly for Phase III. For example, do you have to do a single Phase III or do you have to do multiple Phase IIIs. Also we plan to run these programs under the auspices of the U.S. Food and Drug Administration. And they offer expedited pathways that we're going to look to take advantage of. And examples of those is Fast Track designation, Breakthrough Therapy. So these are all options that are open to us with NYR-BI03. But the length of time largely depends or depends on a number of factors. Another one is the therapeutic area. If you're developing a drug for an orphan indication where only a few patients are affected, you get accelerated opportunities for development. But of course, along the way, there can be failures and delays. And one of the big drivers of completing these studies is the time it takes to recruit patients. So a lot of factors.

As you said at the beginning, this past year has been fairly important, and this coming year will be even more important. So what do you see are the key milestones for Nyrada for the next -- for the coming 6 to 12 months?

Well, the key one is the start of the Phase I study and the updates we'll be putting out around that. The readout from the Walter Reed study, which is due in January. We'll also be lodging IND submissions to the U.S. FDA to support Phase II development. And we're actively pursuing non-dilutive funding opportunities. So where we're successful, we'll certainly announce that to the market.