ARGENICA THERAPEUTICS LTD (AGN) - What A WHO Drug Name Means For Global Trials Artwork

ASX BRIEFS

Welcome to 'ASX BRIEFS,' the definitive podcast for enthusiasts, investors, and professionals keen on staying ahead of the curve in the Australian Stock Exchange (ASX). Hosted by Andrew Musgrave, 'ASX BRIEFS' delves deep into the heart of Australia's financial markets, bringing you insightful conversations with the minds shaping the future of investing down under. Each episode, join Andrew as he interviews a diverse lineup of fund managers, executives, and industry insiders, offering you a unique blend of expert analysis, strategic insights, and the latest trends affecting the ASX. Whether you're a seasoned investor or just starting out, 'ASX BRIEFS' is your go-to source for comprehensive updates and thought-provoking discussions designed to inform, inspire, and empower your investment journey. Tune in to 'ASX BRIEFS' and take the pulse of Australia's financial markets right at your fingertips.

All Episodes

ASX BRIEFS

ARGENICA THERAPEUTICS LTD (AGN) - What A WHO Drug Name Means For Global Trials

August 26, 2026 • Andrew Musgrave

0:00 | 10:44

Send us Fan Mail

A drug’s name can sound like a footnote, but it can be the key that unlocks global trust. We sit down with Dr Liz Dallimore, Managing Director and CEO of Argenica Therapeutics, to explain why the World Health Organization’s recognition of xaranetide (ARG-007) is a meaningful step as the company scales clinical and commercial engagement in neuroprotection.

From there, we get practical about what comes next: Argenica is finalising a late-stage clinical trial protocol in moderate to severe acute ischaemic stroke, and the approach is sharper than before. Liz walks us through how Phase 2 results changed once AI was applied to stroke imaging, revealing stronger efficacy in patients with more severe strokes and larger visible brain injury. We talk precision medicine, why AI imaging diagnostics are now common in hospitals, and how selecting the right patients can give a trial its best chance of showing a real benefit.

We also cover the FDA pathway, including the hERG cardiac safety assay, TNK interaction testing with a clot-dissolving standard-of-care drug, and additional genotoxicity work, plus why trial design and clinical workflow matter just as much as the molecule. Finally, Liz shares landmark pre-clinical data in repeated mild traumatic brain injury and concussion, where a single low dose showed lasting neuroprotection out to 11 days, and we touch on cash runway, grant support and near-term milestones.

If you care about stroke treatment innovation, AI in clinical trials, and where Australian biotech is heading next, listen in, share it with a mate, and leave a review to help more people find the show.

Andrew Musgrave

Welcome again to ASX Briefs. And joining me again is Dr. Liz Dallimore, the managing director and CEO of our Argenica Therapeutics. Liz, great to have you with me again and welcome back to the ASX Briefs podcast.

Liz Dallimore

Thanks so much for having me, Andrew.

Andrew Musgrave

Now Liz, to start things off, the World Health Organization recently confirmed xaranetide as the international non-proprietary name for your lead drug candidate, ARG007. What does this formal recognition mean for the company as you scale up global clinical and commercial engagement?

Liz Dallimore

So, this is a key step when developing any drug. So, you have to apply to the World Health Organization to get what's known as this non-proprietary name. So essentially what it means is it allows clinicians in this sort of later stage trials and also when the drug is approved to actually identify what sort of drug it is. So, the natide relates to the fact that the drug is a peptide, and then the prefix to that is a word that means nothing. So, it can't have any association with really anything that the drug does. So, it just allows clinicians really to understand what sort of drug that they are dealing with. And one of those key sorts of hurdles that we have to get over with the World Health Organization as we progress the clinical development of xaranetide.

Andrew Musgrave

And building on the safety and efficacy data from your phase two stroke trial, you're now finalizing the protocol for a late-stage clinical trial in moderate to severe acute ischemic stroke. Can you explain the strategy behind the trial design and how you're incorporating precision medicine and AI diagnostics?

Liz Dallimore

Yeah, so we are under our sort of phase two clinical trial, which was really a broader trial, really trying to identify where the drug worked, how well it sort of worked across a broader group of stroke patients. What we found is when we applied AI to the imaging, we saw that there was efficacy within patients that had more severe strokes. So, these are patients presenting to hospital with larger visible brain injury on imaging. And this really seems to be where our drug is working the best. So, we can now design a really sort of precision medicine approach type of trial to this later stage, phase 2b, which will hopefully then lead straight into a phase three clinical trial, focusing on those patients. So, and now when we, you know, interestingly, when we started our phase two trial, not many of the sites, if any, actually had these AI tools. Now they're quite prevalent within hospitals. I'm actually here in Brisbane at the Australian-New Zealand Stroke Conference today and have been sitting in and a lot of discussions around just the importance of AI imaging. They actually did a survey in New Zealand that they presented this morning around, you know, the clinicians really wanting to use these AI tools as a way to better stratify and understand what's happening with the patients. So, we will use that AI approach in the next study to make sure we're getting the right patients into this trial and interestingly, again, at this conference, we're learning a lot more about these sort of more severe stroke patients and really the need for a neuroprotective trial in these patients. So, we're pretty excited. We've got a, you know, a way to design this trial really well utilizing AI, which seems to be everywhere at the moment, and really select for those patients where we know that the drug is working best to give this, you know, next trial the best chance of seeing efficacy.

Andrew Musgrave

Now you recently completed three FDA requested safety assays covering hERG, TNK interaction, and genotoxicity. What were the findings of these assays and what are the next milestones for resolving the FDA clinical hold?

Liz Dallimore

Yeah, so when we put in our IND, which stands for investigational new drug application, which is essentially the FDA's way of approving a clinical trial in the US, they requested us to perform three assays. So, they're all essentially safety assays. So, the first one being the hERG assay, which really looks at the impact of our drug on cardiac activity. So, we didn't see any negative impact there, so that gives another sort of tick of safety. The TNK assay is to look at the interaction of our drug with a standard of care drug that dissolves clots in stroke patients. That's a newly approved drug, so that's something that I knew that the FDA required us to do. So, we didn't see any negative drug-to-drug interactions, or another safety tick. And then the last one was genotox. So, we had done quite extensive genotox studies. This is really where the FDA requires a sponsor of a clinical trial to determine does their drug have any impact on the genetic material in cells. So, they just wanted us to do a slightly different cell line. So, we've done that and shown there's no impact on that. In terms of now getting that IND open, the thing that we have been spending a significant amount of time on is the clinical trial design. So, I cannot emphasize enough the importance of clinical trial design. You may have a drug that works exceptionally well, but if you get that clinical trial design slightly off, then you, you know, you could have a failed trial. So, you know, we even saw that in the phase two as part of our clinical trial design. We took the, what was called the site determined aspects, which is essentially a manual process for the clinicians to determine stroke severity. In hindsight, that wasn't the right thing to do, even when we knew that that could potentially be an issue, but that's sort of what we did. So, you know, we're spending a huge amount of time making sure that we get this clinical trial exactly right, that it's also feasible for sites to actually undertake. So, spent quite a lot of time with clinicians this morning, really understanding, you know, what is that clinical workflow? If we're asking you to do these things in the trial, will that be prohibitive? How can we make this work, this trial work best for them so that we don't have really long protracted recruitment timelines?

Andrew Musgrave

Argenica has also announced a landmark pre-clinical result for a xaranetide in repeated mild traumatic brain injury or concussion. Can you walk us through how a single low dose demonstrated lasting neuroprotection up to 11 days post-injury?

Liz Dallimore

Yeah, so this is a study that has been on the cards for quite some time. So, we've got quite extensive preclinical data looking at our drug in more moderate to severe traumatic brain injury. So that would be akin to like a king hit or a motor vehicle accident where you've got quite significant damage to the brain. We wanted to, and we see great efficacy in those animal models. We wanted to understand if that then translates into this sort of mild TBI or concussion. So, what we did in this experiment is we gave a mild TBI to the animals. We left them for 24 hours and gave them another. So, we're really looking at that kind of that sporting injury type concussion where you can get that repeated knock to understand, you know, how well our drug protects the brain following that kind of repeated concussion. We then essentially leave those animals, do some behavioural testing, leave them out to 11 days. We take bloods, we monitor them, and then we see essentially the impact of that drug at 11 days, which is kind of a good indicator because it really lets you look at sort of more longer-term effects as opposed to what's happening really acutely. So even though our drug is being given in that acute phase of the injury, so quite soon after injury, what does that does that have long-lasting effects? So that's sort of why that 11 day is important. So, we saw, you know, great results both in inflammation, which is a big driver of some of those symptoms that we see in traumatic brain injury, but also damage to the actual brain cells themselves. So again, a big driver in some of those post-concussive type of symptoms that we see in terms of memory loss and depression, etc.

Andrew Musgrave

Touching now on your financials, the company closed the June quarter with over six million dollars in cash, backed by significant non-dilutive grant funding. So, how does the runway support your upcoming operational milestones?

Liz Dallimore

Yeah, so we've got pretty good cash position at the moment, which is a nice place to be. We'll also hopefully be putting in our RD tax rebate shortly as well. So, yeah, so we we're in a good cash position in terms of not urgently needing to raise money. We are looking at sort of setting up also a traumatic brain injury trial as well, and then moving into that stroke trial. So, at the moment it's all preparatory activities essentially for those two trials. So well-funded to do that and then once we really lock in the protocol, understand how many patients we need in that later stage stroke trial, then we'll be able to look at sort of where our cash position gets us to.

Andrew Musgrave

Finally, Liz, as Argenica moves closer to initiating its late-stage clinical trials, what's the key message you'd like to leave with investors today?

Liz Dallimore

Yeah, so we've got a lot of pretty exciting milestones coming up in terms of you know leading into that. So, you know, obviously looking to get our um not only our IND approved for running trial sites in the US, but also ethics approval to run that trial in Australia. Some more information coming out to the market regarding that traumatic brain injury trial and that what that will look like and collaborations around that as well and also some exciting preclinical data and other indications coming out as well. So quite a lot of activity over the next six to twelve months. You know, this time in 12 months, Andrew, hopefully we can uh touch base again and we'll have a couple of clinical trials up and running and lots of positive upside for the company.

Andrew Musgrave

Okay, Liz. Well, it's been great to chat again, so thanks for your time, and we look forward to those updates in the upcoming months.

Liz Dallimore

Thanks, Andrew.

Andrew Musgrave

That concludes this episode of ASX Briefs. Don't forget to subscribe, and we look forward to catching you on our next episode.