I work at VECTOR Advisors, and I'm very pleased to be joined this morning by Dr. Liz Dallimore, who is the Managing Director of Argenica Therapeutics. Liz will be well known to many of you, I'm sure. Liz is just going to take the opportunity this morning to provide an update and a bit more color around the announcement that was on the ASX this morning, which was a positive one around the completion by Argenica of ticking off all the FDA-requested assays that were part of their clinical hold for their xaranetide ARG-007, which has acquired a new proprietary name over the last couple of days, and that was also announced. The format this morning, Liz has a presentation, which hopefully is up on screen for everyone to see. She'll run through that. We imagine that would take around 20 minutes. We'll then be open for questions. We received a couple already, so thank you very much for those. Liz is very open to answering your questions. Hopefully we'll look to wrap up at around 9:30. Thanks again for joining us. Liz, I'll let you take it away. Fantastic. Thanks, Matt, and thanks everyone online for joining. I do very much appreciate the opportunity to give everyone an update. I know things have been a little bit slow over the last six months, but rest assured we have been working like crazy in the background at Argenica to get moving on this next stage of our clinical development plan for xaranetide, which is the new name of ARG-007. I will leave plenty of time at the end for questions. I'm sure there is a number of questions from investors. Please put your questions into the Q&A, and I'll do my very best to answer as many of those. Any that I can't get to, I will follow up with you individually just to make sure that I am answering everybody's questions. Hopefully everyone can see the presentation. I'm just going to move through, obviously disclaimer on forward-looking statements. This is just a quick summary of where we're at in terms of the progression of xaranetide, specifically in acute ischemic stroke. I will touch on where we're sitting with our TBI trial a little bit later in the presentation as well. Whilst I think we were surprised by the top-line data that we got out of our phase II trial of not seeing an overall impact on the infarct volume, the more that we talk to industry, to clinicians around our data, the more excited that we actually get in terms of where our drug is working. Why it makes sense mechanistically in terms of how the drug does actually work, and we're starting to collect a lot more data on the mechanism of the drug. We feel now like we've got a really huge amount of data to build that precision of phase II-B clinical trial for acute ischemic stroke patients. What's really exciting about the post hoc analysis is that we're showing statistical significance in that data, which is really exciting given the numbers. The plan for the phase II-B is to essentially confirm what we've seen in that post hoc analysis. Where we're sitting at the moment, as of the March quarter, we had AUD 8 million cash in the bank. We're hoping towards the end of June, that'll be a little over AUD 6 million. We're busy with the manufacturing. That is where the bulk of our money is being spent at the moment. We obviously need to make sure we've got enough of the drug available for that phase II-B clinical trial. We're sitting at a market cap of around AUD 15 million, which is extremely disappointing. I've had a couple of discussions with a couple of our competitor companies recently, two U.S. companies, DiaMedica Therapeutics and Silver Creek Pharma. Both conducted phase II clinical trials, didn't hit their top line, but on post hoc, they've seen this patient subgroup and both are progressing into phase II-B trials. They're sitting at market caps of around AUD 400 million, those two companies. There is such a massive upside for Argenica. That's really the message that I want to get across is that, yes, we were disappointed in the top line, but everything we pulled together on the post hoc, which is really normal in these phase II trials, is really, really encouraging. We've got a really, really clear path to actually prove the efficacy of drug in these more moderate to severe stroke patients. We also will be working really hard on our R&D tax credit for FY 2026. As soon as we hit 1 July, we'll be ensuring that we can get that lodged and get that cash back. That should be a reasonably sized check as well to keep our cash reserves up as we progress into that phase II-B clinical trial. I probably don't need to touch on this too much. I think we all understand just how massive the opportunity is in stroke. I'm not sure stroke gets enough air time in terms of where it's sitting, both in terms of the extent of disability, so impact on the healthcare systems, but also mortality for these patients. One in four people will have a stroke in their lifetime, and that is getting more and more prevalent. In Australia, five years ago, someone had a stroke every 19 minutes. That is now every 11 minutes. In China, stroke is now the number one killer. It's overtaken heart attacks. We're starting to see pharma companies come back into this space. We've got Bayer running a massive phase III trial for an anticoagulant. We've got BMS, Bristol Myers Squibb, and Johnson & Johnson doing the same. We're starting to see a lot more traction in stroke just because of this huge unmet medical need in this area. Again, this is just touching on the patients that we are really going after in this phase II-B trial. These are the patients that have the greatest unmet need. They have the highest burden on the healthcare system, therefore they can attract the highest drug price. Patients in that top end. We talk a lot about ASPECTS scores. This is essentially a measure of stroke severity in patients. The higher the ASPECTS, a 10 is very little brain injury, nine is a little bit more brain injury, all the way down to zero, which is extensive brain injury. Those patients with an ASPECTS of nine or 10 where we didn't see our drug working, they're doing super well anyway. They don't have a burden on the healthcare system. They're walking out of hospital pretty much without any residual sign of disability from that stroke. They're not the patients that we want to target, and neither is that where our drug is working. That is essentially what we revealed from our phase II trial, which is extremely important information and data that gives us a better chance of success as we move forward into our phase II-B trial. What we're starting to do within the company, we had a lot of mechanism data, but we're gathering even more mechanism data based on this idea of this stroke severity. We know that our drug works on open calcium channels. We've started to collect this data to understand how is it modulating these calcium channels. Calcium influx into the brain cells is what kills them from a stroke. It's a really important element of that cell death pathway that we are targeting with our drug. The more severe the stroke, the more channels open, and the more calcium that floods the brain cells. We know that in more severe stroke, we get more channels opening, there's more opportunity for our drug to work. Mechanistically, it makes sense that our drug is working on these more moderate to severe stroke patients. I'll just quickly touch on what we did in the phase II trial. We were looking at patients that were eligible for a thrombectomy procedure. This is a procedure where a neurointerventionalist will aspirate out the clot in the brain, and these are patients that have a clot in a large vessel. Typically, either the internal carotid arteries, which are the two arteries that enter your brain, the big arteries, or what we call the M1 branch, the first branch that comes off that artery. These are the patients that typically have the worst outcomes unless they're in that 9- 10 ASPECTS. We wanted to look broadly in the phase II, where does our drug work? How's it working on this patient group of these large vessel occlusion strokes that are having thrombectomy? We'll do the same, obviously, in the phase II-B, very similar trial design. Sorry. Very similar trial design, except we will just narrow to those more moderate to severe patients where we saw this benefit. What we did when we looked at the top-line data, yes, we were quite surprised how we didn't see that overall effect because in all our preclinical studies, we consistently saw an effect on infarct volume reduction. What's interesting, and hindsight's amazing in these sorts of things, but when we looked back then to really understand that preclinical data in line with our phase II data, when we're running those preclinical studies, these animals typically have more moderate to severe strokes. We typically make sure that there is enough injury within those animal models that we're going to see a drug effect. It all aligns again, both mechanistically in terms of how our drug's working, the biology of stroke, what we've seen in our animal studies, and then what we've seen in this post hoc analysis. The other thing that we noticed in our trial is that the sites weren't great at actually assessing a patient's ASPECTS score. Unfortunately, when we came to do all our statistical analysis, the ASPECTS, we relied on the ASPECTS scores of the site, which essentially meant that our stats were out. What we want to do is rectify that in the phase II-B study. We partner with Brainomix, which is a U.K. company spun out of Oxford University, who has a fantastic tool that is able to automate the ASPECTS score for clinicians. These tools are now readily available within comprehensive stroke units. They weren't, unfortunately, when we started the phase II trial, but we did have an inkling that we would need to get these ASPECTS right, and we would need some AI to overlay this imaging. We actually engaged Brainomix at the beginning of our trial to start ingesting this data. Brainomix is now approved from a regulatory point of view to now be embedded within hospital systems, as are a number of AI tools. There's a U.S. company, RapidAI, which is quite prevalent in U.S. hospitals. We are quite agnostic in terms of the AI technology, but we do know that we need some sort of AI to be able to accurately read these images and give us the accurate ASPECTS stroke severity score. In terms of this post hoc analysis, and as I mentioned before, discussing with a couple of our competitor companies, they've done the same. They've gone and dug into their data post phase II and found where their drug is working. I will note those two competitor companies, one drug only works post six hours, not quite a direct competitor to us. We're focused probably on the earlier stage. The other drug doesn't work with thrombectomy, they're going for a different stroke group. In terms of how they've progressed, it's very, very similar. This is very, very common in these sort of phase II neurology trials. This is the data that we presented at the European Stroke Conference in the Netherlands in May. We were selected for a best poster prize, which was fantastic. This is all the work that we've worked on with Brainomix to really find where we're seeing this efficacy signal. I'm just going to explain this graph in a little bit more detail. On the right-hand side, we've got what we call the infarct volume, and this is at baseline. This is when patients are coming in with a stroke, they get imaged, and we're recording the volume of dead brain tissue on imaging. This is again done more accurately through those AI tools that Brainomix has. We're getting a really accurate score of infarct volume in those patients. On the bottom, the CISC is essentially the infarct volume at day three, when we're doing a follow-up scan of those patients, and again, the AI is measuring the infarct. What you can see is when a patient comes in with a very small infarct, these tend to be the patients in the ASPECTS 10 and 9, as I mentioned before. They're coming in with very little brain injury, and they're leaving with very little brain injury post-thrombectomy. There's not a lot for our drug to really work on because these patients are doing super well anyway. When we start getting into around 20 ml of brain injury at baseline, when those patients are first going in, this is where we start seeing this shift where our drug is really showing just how well it's working in these more moderate to severe stroke patients. We're starting to see that the placebo group really starting to have quite poor outcomes. The more severe stroke they have, they receive the placebo, and they're leaving with quite large, significant brain injury, unless they've had our drug. ARG-007, where we're showing that the drug is working amazingly well in containing that expansion of brain injury in these patients. It's almost pretty much aligned to the types of brain injury that you would see in coming in with smaller levels of brain injury in the, on average, 10 ml and 5 ml. This is kind of a good image. This is, again, what we presented at the European Stroke Conference. This is just showing where you can see exactly where our drug starts to work. Again, that infarct volume on the bottom, on the baseline. You can see at around 9 ml is really where it starts to cross over and work really well. We did have a skew in the data as well. We did have more severe stroke patients in the treatment group. You can see just how well the drug is working. This is giving the probability of whether that patient will have what we call an mRS of zero to two at day 90. An mRS of zero to two essentially means that that patient has very little disability at day 90. The more severe stroke, the greater the chance, if you've had ARG-007, of having minimal disability at 90 days. That's massive. That's absolutely huge. It's what payers want to see, it's what insurers want to see, it's what regulators want to see. Again, this data for us is really exciting. This is just, again, looking at another schematic, and this is important because this is what we will really focus on in our phase II-B study. We're looking at, again, this is a modified Rankin Scale, just a level of disability. We're trying to get more patients in the zero to three mRS. This means those patients can walk unassisted, and from a quality of life point of view, that's really massive to stroke patients. We're trying to shift as many patients essentially from the right side into the left side. Pushing that whole scale over to the right, essentially, and getting more patients to be able to live with less disability. Quickly touching on the clinical hold and where we're at for that. I know everyone's quite keen to understand how that's progressed. We were obviously hoping that these three assays would get done a lot quicker than they have. The CROs that we use for the genotox and the hERG assays, unfortunately, had some technical challenges with their actual assay, nothing to do with our drug, which took them a little while to resolve. These are all done now. These are the three assays that the FDA required, and we're showing a kind of clean safety profile. We did contact the FDA to say, "Look, do you want to have a look at what we've done, our data package so far through what's called a Type A meeting?" They've sort of suggested just put in the clinical hold response, we'll go from there. That's the plan. We've done some more acute toxicology work. Just to provide a bit more color on, when you're running drug studies, you've got to find the level in which is what we call the maximum tolerated dose. How far can you essentially push the dose until you start seeing some tox signals within the animals. We've done a bit more work just to give a bit more color around that, just taken more samples, a bit more data. We're currently finalizing the phase II-B protocol. That then needs to be reflected in what we call the Investigator's Brochure. This is essentially what goes to all the principal investigators and all the hospital sites for our trial. We're hoping to get the complete clinical hold response into the FDA. We have addressed all their questions. I will caveat that by saying there's been a lot of turnover within the FDA, there's a lot of changes. We can't predict. They might not come back, different people are actually looking at this study, that they might come back with other questions. We're really hoping that that's not the case and that they do give us an opportunity within that 30 days to actually address any further questions that they had. Just onto the phase II-B trial design. As I said, it will be really similar to the phase II, we'll focus on those ASPECTS of around three to eight. We're just refining exactly what that will look like, and that will be that AI-assisted interpretation. We won't require sites to necessarily use the Brainomix technology. If we were to do that would actually end up on our drug label, that the drug could only be used with the Brainomix software. We want to avoid that. We're agnostic in terms of the type of software that the hospitals use to assess the ASPECTS, then we'll just account for any differences within our statistical analysis plan as well. Again, large vessel occlusions that are undergoing thrombectomy. What we're doing this time though, is we're looking at a primary endpoint around functional outcomes. This is essentially the endpoint that we would need to get the drug approved. This is that disability score I mentioned before, the mRS. We will also look at a number of exploratory endpoints within that as well. It will be randomized placebo-controlled, and we're going to test a lower dose as well. We're going to obviously test the dose that we saw efficacy in the phase II trial. We also want to test a lower dose. We've done work, and we put this out to the market around some more preclinical work to really understand where the drug is working best. We will build in an interim analysis within this, which may allow us to drop one of those dosing arms. It'll be an interim analysis on a functional endpoint. If that's looking good, that'll be a huge value inflection point to the market as we'll be able to announce what that interim analysis looks like. Just quickly touching on who's helping us design this phase II-B clinical trial. We've had a refresh of our clinical advisory committee. We've brought on another U.S.-based neurologist, Dr. Taylor Kimberly. He's Professor of Neurology at Harvard Medical School. Huge amount of expertise, both in imaging and also running stroke clinical trials as well. We've also brought on Dr. Michael Devlin, who was one of our absolute standout principal investigator and recruiters out of Princess Alexandra Hospital in Brisbane. He's been absolutely fantastic in helping us navigate this trial design. We've brought him on too, and we still have Tim Phillips, who's a Perth-based neurointerventionalist. Professor Geoff Donnan, who's an absolute superstar in the field of stroke out of University of Melbourne, and Jeff Saver as well, equally a superstar as Geoff Donnan. Just quickly touching on where now we're at with traumatic brain injury. We did announce to the market that we're looking to push into clinical studies in TBI. We're just in the process of finalizing some partnerships with some really leading Australian institutions within traumatic brain injury research and clinical trials. That's coming to the final stages. We've got a couple of grant applications in, and we're also looking at some opportunities around philanthropic funding as well. That trial will be a smaller trial. It will be open label, so more opportunities to announce data to the market, and it'll be really assessing how well is the drug at reducing some of these blood and imaging biomarkers. We're busy working on a few publications in relation to our preclinical studies in that area. I'm conscious of time, just quickly going to touch on what these catalysts look like for the second half of this calendar year and the first half of next calendar year. It's all very much focused on getting those two clinical trials up and running. All the regulatory work that we need to do for that. The IND, getting the IND open is obviously a key priority for the company. Parallel to getting the IND open, we'll have the majority of the sites still in Australia, but obviously doing those U.S. sites so we can get the HREC approvals to actually start the study in Australia whilst we're still working on the IND as well. Once we have the phase II-B protocol locked down, we can start looking at getting approvals to start in Australia. The large-scale manufacturing. We've had to do commercial scale manufacturing. That is a long process. We started that in January last year. The drug will be available to start dosing at the end of this year, early next year. Getting HREC approval for that TBI trial, and then focusing really on execution of those trials in the first half of next year. Thank you. I will leave it there, Matt, and open it up for any questions. Right. Thanks, Liz. We've had a couple come through. Thank you for everyone. Also just a reminder, send them through if anything's on your mind. A couple that have come through, Liz, is one of these. Has the FDA indicated whether the completed assays fully satisfy their concerns, or should investors expect additional requests and further clarifications? I know you touched on that on the presentation, but just worth reiterating. I can go into a bit more detail. The only kind of things that the FDA did ask us was to do those three assays, and also just a bit more changes in formatting of the Investigator's Brochure. We have addressed all of their questions and concerns, which we will present obviously in the clinical hold response. Will they come back with more questions? That is the great unknown, unfortunately, with the FDA at the moment. Look, we're putting in a pretty comprehensive package. The FDA is mainly concerned with safety, right? We will be presenting all the safety data from the phase II trial as well. We've got all that to go on. That will be additional information and data that we'll be able to present to them. Hopefully, that they are completely satisfied and open that IND. Okay. A little bit of interest around just a bit more detail, I guess, on the phase II-B trial and the size and the patient numbers and other things that might be relevant to that work. Yeah. Look, we're pretty close to bedding that down. Given we've shifted the primary endpoint into a functional outcome, which is essentially a qualitative measure, it means that we need more patients within that trial to be able to give us the right number to pull out that benefit that's statistically significant. We've been working with a couple of U.S.-based biostatisticians to really help us understand what that number is. It's going to be in the order of around 350, 400 patients. We'll look to bring on sites again in Australia, so reactivating those 10 hospitals that we had involved in the phase II trial, and bring on some sites in the U.S. as well. Obviously, given that we'll have more sites, we should be able to run the trial at recruitment rates quicker. We will do an interim analysis, as I said, to about 50% of patients recruited. Around the 160 patient mark is when we'll start to look at the data and see, is one particular dose working better than the other? What does that look like? Do we need to change the pairing of the study? Is there anything that we might need to do to adapt the study to really draw out, hopefully, an efficacy signal that we're seeing? That will be a large value inflection point, so sort of raising enough capital to get us to there. We're looking at funding that part of that first part of the trial through a combination of grants funding. We've got a number of grant applications in, obviously, raising some more capital. Hopefully, I'm working pretty hard to see if I can get a potential pharma partner to come in and support the trial. A little bit harder at this phase II stage. If we get good phase II-B data, in the interim analysis, that'll make it a lot easier to get a pharma partner to come in and fund the rest of the trial. Right. Okay. Just on the funding topic, there's been a couple of prompts on funding for the TBI side of things and in particular in around the grants and the funding requirements that might be required for that, how is the non-dilutive funding looking? TBI does lend itself to non-dilutive funding. Both for governments and philanthropy, it's quite a hot area of research and a hot topic. We feel pretty comfortable that we'll be able to attract that. That trial won't cost a huge amount of money. The sort of lead investigators on that trial will do a lot of the heavy lifting. It won't actually cost Argenica anything much at all, if anything. We'll be able to attract that funding actually directly into the hospital and university sites that will be undertaking the trial for us. A lot more opportunity around non-dilutive funding where it's running through the university research institute sites. Brilliant. Just one on the-- it's a bit topical, probably on everyone's minds. It's an AI-related one on the Brainomix. Yeah. The use of that in the phase II-B trials. I know in the initial trial it maybe wasn't available in Australian hospitals. Yeah. How will that sort of fit into what you're doing? It looks like it's very exciting. Absolutely. Obviously really critical in terms of getting our phase II-B trial right. As I mentioned in the presentation, we've got to be a little bit careful. We can't specify a specific type of software because that will end up on our drug label. It will be, you can give this drug if you've used the Brainomix software or the RapidAI software. We want to be software agnostic. We want, obviously, the sites to use the software. We had a clinical advisory committee meeting on Tuesday morning, and the cap was very in the U.S., across Australia, pretty much every comprehensive stroke care unit is using some form of AI. What we now do is we look at any potential discrepancies in the algorithms and account for those discrepancies when we run through the data through the statistical analysis plan. Brilliant. Okay. Look, I think I sort of reached our sort of time limit of around 9:30. Thank you, everyone, for attending. I think, as Liz has clearly pointed out, there's a lot to look forward to for the company. One of the interesting things that I sort of heard during the presentation was there's that significant value disconnect, perhaps between some other U.S.-based companies that might not have achieved quite to the same level as Argenica. I hope I've got that right, Liz. Just pointing to a lot more upside for the company. I know the team's working really hard, and there's a lot of good things ahead. It's a bit like the classic sort of duck swimming on a pond. At the end, it might be a little bit quiet, as Liz said, at the top, it looks that way from a public sense, I know they're paddling really hard underneath. Lots to look forward to. Thank you, Liz. Thank you, everyone for joining us. Thanks, Matt. Have a great Thursday, everyone. Thanks, everyone.