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ARGENICA THERAPEUTICS LTD (AGN) - Neuroprotection For Stroke, Explained

• Andrew Musgrave

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A lab surprise turned frontline hope: we sit down with Dr Liz Dallimore, CEO of Argenica Therapeutics, to unpack a peptide drug designed to protect the brain during the chaotic minutes after stroke and other injuries. Built from a chain of arginines, the therapy targets the glutamate‑driven calcium surge that kills neurons, aiming to stabilise tissue while clot dissolvers or thrombectomy restore blood flow.

We trace Argenica’s journey from Perth lab benches to a multi‑centre Phase 2 trial across Australia, where the drug met its primary safety endpoint and showed encouraging trends in functional outcomes at day 30 and day 90, including a 23% improvement in cognitive impairment at day 90. Just as important, the 10‑minute IV infusion fits the reality of emergency care and did not interfere with the efficacy of standard clot‑busting drugs. That bedside practicality matters for hospitals and regulators alike, aligning neuroprotection with established stroke pathways.

The conversation digs into AI‑enabled imaging with Brainomix to better understand collateral flow, penumbra, and the fast‑progressor subgroup where an efficacy signal emerged. We also explore the broader pipeline: compelling ferret data in traumatic brain injury that supports a direct move into Phase 2, and an FDA‑orphan backed program in hypoxic ischaemic encephalopathy for newborns, now progressing through piglet studies and heading toward an IND and potential Fast Track. On capital, Liz outlines a pragmatic plan combining cash on hand, the R&D tax rebate, and non‑dilutive grants such as US Department of Defense funding to advance multiple trials without slowing the pivotal stroke study.

If you’re tracking innovations in stroke treatment, neuroprotective drugs, AI imaging in acute neurology, or the future of TBI and HIE care, this is a clear-eyed look at what’s working, what’s next, and how trial design is sharpening to benefit the right patients at the right time. Follow the show, share it with a colleague, and leave a review to tell us which milestone you’re watching next.

Andrew Musgrave: 

Welcome again to ASX Briefs, where we speak with the leaders from some of the most innovative small and mid-cap companies listed on the ASX. And today we're joined by Dr. Liz Dallimore, the CEO and Managing Director of Argenica Therapeutics Limited. Argenica is a biotechnology company developing novel therapeutics to reduce brain tissue death after stroke and other types of brain injury. Liz, thanks for joining me today and welcome to the ASX Briefs Podcast.

 

Liz Dallimore: 

Thanks for having me, Andrew. Great to be here.

 

Andrew Musgrave: 

Now Liz, for investors that may be unfamiliar with Argenica Therapeutics, can you start by giving us a brief overview of the company?

 

Liz Dallimore: 

Yeah, sure. So Argenica is a spin-out company from a research institute in Perth in Western Australia, the Perineuroscience Research Institute. So, it's the company is backed by over a decade of scientific endeavour by our chief scientific officer, Professor Bruno Maloney, who discovered our lead drug candidate when he was the head of the stroke research lab at the Perron Institute. That preclinical data and that sort of scientific endeavour was hugely compelling. I was actually on the board of the Research Institute at the time, and it was really a differentiated drug to anything that we had sort of seen in other research institutes globally, sort of pursuing this idea of protecting the brain after brain injury. So, we spun that company out in 2019 and listed on the Stock Exchange in 2021, still as what we call a pre-clinical company. So, in that time we've sort of taken that lead drug asset through sort of preclinical, phase one clinical trials and through a phase two clinical trial in stroke. So just quickly a bit of background on the drug and what it does. It's what we call a neuroprotective peptide drug. So, it's a drug that has the ability to protect brain cells following injury. There are currently no neuroprotective drugs approved on the market for any type of brain injury. Because the drug has come out of the stroke lab at the Perron Institute, we are focused on the majority of our data is actually in what we call ischemic stroke. These are strokes caused by blood clots in blood vessels in the brain. They make up around 85% of all strokes. So that is essentially what our phase two clinical trial is in. But huge amount of preclinical evidence. We have only over 26 peer-reviewed publications on the drug, both in terms of efficacy in a number of different animal models, but also safety and the mechanism of action by way the drug works. So, it's fantastic to have so much science backing the company, and it really gives us that conviction as we take this drug through clinical trials.

 

Andrew Musgrave:

Okay, and just touching on the lead candidate, which is ARG-007, can you explain its unique nature and how its neuroprotective mechanism is designed to work alongside current treatments like clot removal?

 

Liz Dallimore: 

Yeah, so the drug was actually accidentally discovered, which is, I guess, sort of quite unusual in terms of drug development, but you know, it's in terms of you know the ability to work on multiple different pathways, it kind of makes sense that it was accidentally discovered. So, our chief scientific officer, Professor Maloney, that I mentioned previously, he was actually working in the lab in a with a another drug that he was trying to get across the blood-brain barrier and into cells. And he noticed that to do that he had to conjugate or add an extra little drug to get it into cells, this this other drug he was working on. And he noticed this conjugated drug, which was what we call a polyarginine. So, it was nine arginine’s, all in a row. Arginine is just an amino acid. It had this capacity for neuroprotection, so to protect cells after an insult to them. And so essentially that's how he discovered it, and he sort of optimized that drug for neuroprotection. So ARG-007 that you mentioned, it is 18 arginine’s, and it is both the arginine content and the structure of the arginine that lends itself to the neuroprotection. So essentially, the way the drug is working is when you suffer sort of some sort of brain injury, be it ischemic stroke, traumatic brain injury. We even see this in neurodegenerative diseases such as Alzheimer’s; is you get an increase in your brain of a neurotransmitter called glutamate. And when you have too much glutamate circulating in your brain, it actually opens up all these channels on your brain cells or your neurons, which causes calcium to start flooding into those brain cells, which leads to those brain cells dying. So essentially, what our drug is doing in the first instance is it's blocking those channels on the brain cell surface to stop that calcium coming in and almost like hibernating the brain, so buying patients time to get the treatment that they need. What we've discovered in our phase two clinical trial, so if we take ischemic stroke, it's really important in any drug development that we can fit into the current standard of care. So, we were really assessing how well our drug can fit into the current standard of care. If a patient coming into the emergency department with an ischemic stroke, they will typically have one of two sort of treatments or a combination of the two treatments. So, they can get what's known as a clot dissolving drug, a drug that is delivered via IV infusion that dissolves the clot. They can have that in combination with a procedure known as a thrombectomy, which is essentially sucking out the clot from the brain, or they might just go into thrombectomy. So, really, what we wanted to understand was does our drug impact the efficacy of that clot dissolving drug? That is a key question that any regulator is going to ask when you're developing a new drug. You have to show that it doesn't have any impact. So, we've shown that in the phase two trial. The other thing we've shown is that it's actually really easy to administer within the emergency department. Our drug is a 10-minute IV infusion, so it doesn't impact the ability for those patients to get the current standard of care treatments that they need, and which, as you can imagine, in a very acute life-threatening situation, such as an ischemic stroke, it's really important that any drug does not delay or slow those delivery of those treatments.

 

Andrew Musgrave:

Okay, and you've recently announced positive results from that phase two trial. So, meeting the primary safety endpoint and showing promising trends in functional outcomes for patients. So, what are the next key steps as you analyse the data and plan for a targeted phase 2B trial?

 

Liz Dallimore:

Yeah, so we ran a phase two study, as you said, we ran that across 10 emergency department hospitals across Australia. So, we were dosing patients that were coming in with what we call a large vessel occlusion stroke. So, these are strokes caused by a really big clot in one of the big vessels that that come into the brain. And we wanted to, first of all, in neurology drug development, you've got to firstly show that your drug is safe. So, we've done that. So that isn't that is pretty much a go-no-go sort of decision essentially to take it to the next stage of drug development. So that was a good tick. We showed that we didn't have that impact on those clot-dissolving drugs, which is what the FDA really required us to show. So that's great. And then we were looking at a number of efficacy outcomes. So, we were looking at both what we call infarct volume, so measuring on brain imaging the amount of brain cell death, the actual volume of brain cell death that we see on the imaging, as well as you know, functional outcomes. So, looking at both day 30 and day 90 post-stroke. The functional outcomes are actually really, really important in stroke because these are we need to see a change in these functional outcomes to actually get the drug approved. So, we looked at infarct volume to kind of give us an idea of um, you know, quantitatively by measuring on imaging, can we sort of see a difference? And that only really tells us a difference about the ability of the drug to stop that brain cell death. It doesn't tell us anything about you know the other things that we know the drug does in terms of reducing inflammation, reducing edema, any of those things. So, again, that's why functional outcomes are really important. So, we did see a 23% improvement in cognitive impairment at day 90. Cognitive impairment for stroke patients is a really important quality of life metric, and that had a p-value of 0.06, s0 almost close to significance, but really one that we're really kind of interested in pursuing moving forward. We also saw a number of other really key functional outcome improvements. So, improvement in the ability for stroke patients that had ARG-007 treatment to just perform daily activity tasks. So, again, a really important sort of functional outcome. So, we saw an improvement across every functional outcome measure that we did. We saw this trend in efficacy with patients that did receive our drug, which is really exciting and kind of gives us that confidence as we move into that pivotal study.

 

Andrew Musgrave: 

Okay, and beyond stroke, your pipeline includes indications for Traumatic Brain Injury and HIE. So, can you comment on the strategy for these programs, particularly the TBI program, which you noted can move straight from preclinical to a phase two trial?

 

Liz Dallimore: 

Yeah, so um TBI is actually really exciting. We announced some data earlier this year looking at a ferret model in traumatic brain injury, and this is sort of you know replicating a more of a moderate TBI, so it would be the equivalent of you know taking a pretty heavy knock to the brain and losing consciousness for you know a few seconds as opposed to a concussion that that may be sustained. So, we're looking at those more moderate TBIs in this particular animal model. The reason that we do ferrets, so we had some really good rat data, but the reason that we do ferret models is because the brain architecture is more similar to humans. So that's really important in terms of that preclinical development. And so, the data that we got out of that ferret study was hugely compelling, and where the drug was actually reducing a number of key hallmarks that indicate brain injury and TBI, reducing those levels right back to normal levels. So, we really want to pursue this indication in clinical trials. We have set up a clinical advisory committee that is chaired by Professor Terry O'Brien, who's a a really well-respected, well-known clinician scientist in the area of TBI, and we'll be working with a current cohort study known as Predict TBI, which is assessing biomarkers and the like. So, really exciting in that area. We're also working on an indication, which is a and we've got orphan drug designation from the FDA on hypoxic, ischemic, and encephalopathy. So, this is quite similar to stroke, but it affects newborn babies where they are deprived of oxygen and blood flow is restricted, typically happens during childbirth, such as when the cord is wrapped around the baby's neck, or they typically, if the mum has preeclampsia and they have a reduction of oxygen exposure. This causes brain injury, pretty similar mechanism to stroke in terms of you get a really high increase of glutamate in these babies because of the reduction in blood flow and oxygen that's being delivered to the brain. So, we're currently working on piglet studies in that, which we hope to announce to the market towards the end of the year and again thinking about clinical development in that indication.

 

Andrew Musgrave: 

Okay, now you've also engaged the AI diagnostics company, Brainomix, to provide deeper insights into the child's brain imaging. So, what do you hope to learn from this analysis, especially regarding the slow collateral patient subgroup?

 

Liz Dallimore: 

So, and I I probably haven't touched on it too much around the slow collateral patient subgroup. So, these are where we did see a 15% reduction in brain injury in the treatment group. These patients are what we call fast progressors, so their stroke actually progresses really quickly, and that's because they don't have enough blood flow getting to the area of brain injury to sustain, you know, to stop that brain from dying. So, they progress quickly, they have the worst functional outcomes. So, we did see an efficacy trend in that subgroup. And so, what Brainomix does, this is a spin out of out of Oxford University. We've been working with them for a couple of years; they've got now got FDA approval for their diagnostic tool. The AI that looks at the brain images that we've collected can just give us so much more information. We do know there has been quite a significant skew in the patients that came into the treatment group. So, they had worse brain injury. So, we do want to now with the with the Brainomix imaging just unpack a little bit more around what we can actually see on that imaging. It can give us a bit more granularity in terms of the penumbra, how much salvageable brain tissue these patients had. So, it really gives us just you know a lot more information. I'll just say this phase two trial, it's what we call a signal searching trial. So we kind of throw the net out quite wide in these phase two trials and just try to understand where is the drug working so that we can design when we're going into designing what we call a pivotal trial, that we can actually then hone in on that efficacy signal and give that drug the best chance of working in that particular patient group.

 

Andrew Musgrave: 

Okay, now just touching on the financials, you've stated the company is well funded with a cash balance of around $7 million and an expected R&D tax rebate of between three and four million dollars. So, how are you prioritizing capital allocation between the planned phase 2B stroke trial and advancing your other pipeline projects?

 

Liz Dallimore: 

Yeah, so we at the moment we've got grant funding for the HIE into finish up the TBI. So that doesn't essentially come out of our capital allocation. That's all funded through grant funding. So, the majority of that sort of seven million dollars plus you know the top-up of four million dollars will you know really kind of gives us time to focus on the design of the next stage of the stroke trial. And then we'll also look at some non-dilutive funding to take the TBI trial of TBI indication into clinical trial as well. So that the cash sort of kind of gets us pretty far along the line at this stage. It gives us time to, you know, make sure we are designing the right what we call a phase 2B trial, that pivotal trial in stroke. And then yeah, really focused on grant funding. So, you know, the TBI is a really exciting area. We're looking at some grant funding from the US in particular, US Department of Defence, where obviously traumatic brain injuries are really prevalent in defence personnel in the US. So, there is pots of money that um can support and precedence for Australian companies getting those pots of money. So very focused on non-dilutive funding at the moment and you know, conserving that sort of 11 odd mil that we'll have cash in the bank.

 

Andrew Musgrave: 17:10

Okay, now Liz, just to wrap things up, if we look ahead to the end of next year, what is the key message you'd like to leave with investors and potential investors?

 

Liz Dallimore: 17:18

Yeah, so looking to the end of next year, we'll um, you know, we've we'll have our you know phase 2B pivotal trial up and running and hopefully of dosed our first patient in that. We'll have a TBI trial also up and running and hopefully of dose patient in that. We'll have more data on our hypoxic ischemic and encephalopathy preclinical studies, we'll have our IND approved with the FDA, we'll hopefully have fast track designation with that as well. So, there's a huge amount going on for the company leading into to end of next year with a couple of indications in the clinic, you know, hopefully, you know, good approvals and regulatory incentives from the FDA as well. So, yeah, a lot to look forward to. So, you know, and lots of lots of key value catalysts coming up as well. So, it's exciting.

 

Andrew Musgrave:

Okay, well, Liz, great to have chat today. So, thanks for your time, and we look forward to the further updates from Argenica Therapeutics in the upcoming months.

 

Liz Dallimore: 

Thanks Andrew, appreciate it.

 

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.