Welcome to webinar and Q&A following announcements through the week regarding FDA feedback on the proposed phase II-B trial of imsulostat in myelofibrosis, the capital raising, and the Appendix 4C quarterly, which was just lodged with the ASX. All participants are in a listen-only mode. There will be a presentation initially, which will go for approximately 20 minutes, after which we'll take questions taken from those submitted via email and live during the session. If you'd like to submit a question, please do so using the Q&A function within Zoom, and we'll get to those at the end. On the webinar from Syntara, we have the CEO, Gary Phillips, and I'll hand it over to him now. Thanks, Matt. Thank you to all of you who've called in this morning. The title of this first slide is about the positive FDA review of imsulostat. Of course, we've also got a capital raise and the quarterly to review as well. There's a fair amount of content here. I will step through it and try and stick to the things which I believe are most relevant for investors. I'm happy to take any questions at the end about any of these topics. Now if I'm looking at this overall view of the slide, I think the things that we're gonna focus on today are, first of all, the lead asset, imsulostat. We've reported on positive data from phase II last year. Now we have an agreed way forward with the FDA for the next trial. I'll spend some time going through why that's important, what the relevance is that for shareholders, and what it allows the company to do next. We'll then look at the capital raise, clearly the pro forma here is now up to AUD 16.9 million, assuming the AUD 8 million placement proceeds. It's not including anything from the SPP. That gets us through to quarter three 2027, which when we get to the pipeline slide and you see the news flow and when that's coming, will be a really very relevant time period for you to look at. You know, imsulostat is worth, I think, just recapping what it is it about this asset which is exciting. Where has it got to? What's it already achieved? Where does it go next? You know, this is an asset that's already had IND orphan drug designation, going through also Fast Track. It's a first and best in class in its area, that's important in terms of there are no other drugs in development in myelofibrosis or other blood-related cancers, or in fact, any other indications that cover off this particular enzyme group. We've got a global lead in this area, we've demonstrated efficacy and safety from this particular area. We need to protect that, and we need to think about how we can exploit it going forward, particularly in the background of its, it's got a very long patent life as well. This, you know, our lead asset, imsulostat, has a patent out to 2042. There are ways we can even improve on that. It's already got multiple nature publications, both for preclinical, across several different indications, including blood cancers and also solid tumors as well. Not only the publications, but we've reported on the clinical data in environments where we've got the world's global meetings of the hematologists, looking and assessing what we've got and getting their commentary on the data that we've had to date. I think everybody agrees that what we have is a clearly differentiated and very competitive both safety and efficacy profile. That has the potential for a Breakthrough Therapy in myelofibrosis because these patients are currently inadequately controlled, many of them on this current standard of care. There are a number of different ways that clinicians are trying to solve that. Ours stands out in terms of its safety profile and the early efficacy signs as well being very promising in an area which we think both patients and clinicians will be very receptive to. What we can talk about today, though, is what the FDA think of all that as well, and the importance of that. Myelofibrosis is this fibrosis of the bone marrow, our body's blood production unit. These patients have about 5 years to live, and they're currently treated on a drug called a JAK inhibitor, which, although helpful in some extent to, in terms of spleen size in particular, and also in reducing their symptoms, also causes a lot of cytopenias, so dropping red cells and platelets in particular, meaning that the clinicians have to reduce the dose of the JAK inhibitors being given. As a result of that, obviously the drugs become less effective, and eventually they have to drop off of these drugs, and then they only have about 12 months to live when that happens. There's a large unmet need there. Despite this sort of limitation, the market for these drugs is approaching AUD 2 billion per annum. Because of the unmet need, there's a lot of commercial interest in any drugs which are being developed in this area and have clinical data. I'll show you the chart in a minute of the deals that have been done, of which there was another one earlier this week, which it's not on the slide, but we can talk to. Imsulostat has a distinct mode of action. It's inhibiting this family of enzymes that cause the increased bone marrow fibrosis and growth factor activity within the bone marrow. Both of those have a very detrimental effect on the production of healthy blood cells. Blocking that enzyme, preclinically, it showed great promise and also now in the clinic shows great promise for these patients. What we've demonstrated with the trials we've run to date is that, we see a really significant improvement in symptom score. I'll relate this back to the conversation we had with the FDA in a moment. Clearly, symptom score is probably the most important endpoint for patients and clinicians, but also the regulator as well. You know, three-quarters of the patients in our study beyond 6 months had a reduction in symptom score of 50% or more, and that is quite an outstanding result relative to current drugs on the market and also drugs in development. That's a figure and an aspect of the drug which is compelling and is attracting a lot of attention from both the hematology world but also pharmaceutical companies that are following this space as well. We also see reductions in spleen volume, and as I mentioned before, this, you know, a really strong safety signal. What happened with the FDA? If you remember back to last year, we had gone to the FDA with a proposal for an adaptive phase II/III study. The FDA took a more conservative approach than we were expecting and kind of said, "You know, rather than do an adaptive design, we believe that you should do a phase II-B study, look at the results of that, and then design the phase III that comes after it." Having listened to their feedback and consulted with our both clinical advisors but also regulatory advisors and people that had recent experience with the hematological non-malignant division in the FDA which we deal with, we submitted a proposal for a protocol and a clinical pathway for the drug going forward. And we had a meeting, a face-to-face meeting with the FDA in Washington. We sent a small team there to meet with them to have a really good discussion and to make sure that we had a good understanding of what the drug was doing, what it was capable of, and the rationale behind the protocol that we had proposed. I'm pleased to say that that meeting was, I think, the... I would describe it as collegiate. We discussed all the potential issues that there were with the development path, came to agreement on how those would be played out within the next phase II-B protocol, and we now have FDA support for that clinical trial design. The next step in this is to give them a very detailed protocol on the back of this, but that's really only a minor step at this point. We have agreement on the protocol itself, the broad strokes of the protocol and how that will be placed in terms of size, how it's blinded, the entry criteria for the patients that are gonna be there, et cetera, et cetera. I think of note at this point also is that having discussed all the potential endpoints for this study, of which there are, you know, mainly symptom control, spleen volume, but also some other hematological endpoints as well in terms of blood counts, the FDA were very clear that, you know, that they're very comfortable with the idea of us having a primary endpoint which is TSS50, a 50% reduction in the Total Symptom Score. Now, you remember back to my earlier slide, that is the key strength of this drug. You know, compared with other competition, that is the one endpoint which really stands out as being potentially, with a small, relatively small study to this point, being a real breakthrough in this particular disease. We're very comfortable with the idea that we have TSS50 as the primary endpoint. Clearly, there will be other endpoints as well, secondaries and the thing, we now have an outcome for a clear path to advance the drug into late-stage clinical development, which is a really positive step forward for both the drug and the company. This is the protocol itself at a high level, you'll see that we've got two cohorts in here in this design. One of them is dealing with patients who are on the current market leading drug, ruxolitinib. 75 patients would be on ruxolitinib, 50 of them will be on amsulostat as well, and 25 of them on placebo, so it's a two-to-one randomization. In the other cohort, we're also considering the inclusion of momelotinib, which is a drug from GSK, another JAK inhibitor, which has taken about 25% of the market. It's for patients with myelofibrosis who are also anemic. Given the market, we think that's also an interesting cohort to follow. The study itself will run for nine months. Many clinical trials in myelofibrosis run for six months in duration, many of them have spleen volume as their primary endpoint, or co-primary endpoint, largely because the nature of a lot of these drugs is spleen volume is something they work on. As I said, FDA very comfortable with the primary endpoint of symptoms, TSS50. Very comfortable with the idea that we run this study to a length which we think suits our drug, and we have seen that a really competitive advantage of our drug is that the increases and improvements in symptom control and spleen volume don't plateau and stop at 6 months. The response to the drug keeps on deepening as we go beyond six months, and we wanted to capture that within the study design, so we are looking at these patients out to 9 months. We think that the study will be ready to start. We're investing in the clinical trial supplies for this now, and we'll be able to start it by the end of the year. Why does this milestone matter for investors? I think, first of all, the formal alignment with the FDA very much de-risks the regulatory and development pathway. That in particular strengthens imsulostat's value ahead of potential discussions with partners. If you think of it in this way, the FDA has validated the program that we've run to this point and agreed with the process which we'll run further going forward. It removes a lot of questions around the development of the drug which potential partners would want to be addressed before investing in it. It reinforces our differentiated position with the Fast Track and Orphan Drug designations already secured, I think this is a really positive step forward. Of course, we've also got the additional upside of those two studies in myelodysplastic syndrome and related bone marrow cancer that are already underway. We see those as producing preliminary data before the end of the year. We now have a validated strategy for amsulostat. It's a clearer path to value creation. Within this one drug, never mind talking about the rest of the pipeline, within this one drug, we now have multiple near-term catalysts for shareholders, some of them within the next 12 months. We talked a little bit about, you know, the interest from strategics, and I think many of you have been following the story have seen this slide before with the two drugs over on the right-hand side being other JAK inhibitors, which sold after phase III data for AUD 1.7 billion and AUD 1.9 billion. Novartis acquisition of MorphoSys for pelabresib, which was AUD 2.9 billion after phase III studies in 2024. That drug has not made it through to the FDA on the back of the existing phase III studies, and we understand it's having to do a further phase III study to address concerns that the FDA and the company have over that drug at this particular moment in time. We've got the two on the right, which are perhaps a bit more relevant for us in that they are drugs which are at phase II. Therefore, they're not completed phase III. They've got limited amount of phase II data, and we've got examples there of upfronts which are between $100 million-$200 million, and both of them with deal values more than $1 billion. I should add to that we had another deal that was announced earlier this week, with Lilly acquiring a company called Ajax. Ajax have a variation on another JAK inhibitor. It's being positioned as a JAK inhibitor that may have improved efficacy over existing JAK inhibitors based on preclinical data. It's not known yet whether it will have the same tolerability issues that other JAK inhibitors have. Certainly, there's a strong link between the mechanism here of a JAK inhibitor and the tolerability and toxicity that exhibited it. We will have to wait and see how much improved that JAK inhibitor is. This was a JAK inhibitor that has, I think, only got phase I data. They haven't published the phase I data that they've got yet. We're not expecting to see it until next year. Lilly, having invested early on in Ajax in an earlier round, the deal they announced this week was worth AUD 2.3 billion. They haven't announced what the split is between the upfront and the milestones that would go through. Clearly, the upfront will be smaller than we're seeing on the right-hand side with those other drugs post phase III. It's just another endorsement of commercial activity in this space and the desperation of companies to try and find something that is an improvement on what is there. Even a slightly improved JAK inhibitor is attracting deal sizes which are in the hundreds of millions AUD upfront and multi-billion AUD deals even for drugs with just phase I data. We have an asset which has gone through phase I and already has phase II-A data as well. Just to round out the company update before I just get to the capital raise, this is the news flow for the period. You'll see when we get to the capital raise that all of these endpoints here are within the runway that we have with the raise that we've just accomplished. Clearly, we've now got the FDA-approved development plan, and we will be in a position to commence the phase II-B study later this year. We're expecting interim data from the two MDS studies by the end of the year. The topical pan-LOX inhibitor, which is the same technology delivered as a cream, the only pharmacological treatment that's going through clinical development at the moment in this particular kind of skin scarring that we're aware of. Huge hope for this as a medication based on earlier clinical placebo-controlled studies which showed, you know, that this mechanism does improve the structure of scars and the vascularization of scars. We've got two studies, one in hypertrophic scarring and one in keloid scarring. Both of those studies are still in the recruitment phase. We do expect to have results from both of those studies in the second half of the year. Finally, one that's very imminent now is our study into a sleep disorder, IRBD, where the patients go on to develop Parkinson's disease. We expect that study is already fully recruited. The last patient has had their last visit, so we are now in the analysis phase. We expect to see data from that study before the end of quarter two, at least from the primary endpoint before the end of quarter two. There's a lot of news flow to come here, and all of it coming from drugs in phase I-B or phase II trials where we're expecting to see both safety and efficacy results, which will be real value events for Syntara and its investors. Just then briefly touching on the capital raise that we completed yesterday. We've raised AUD 8 million via a institutional placement. We're also targeting approximately AUD 2 million from a Share Purchase Plan for total proceeds of around AUD 10 million before costs. The capital raising was clearly on the back of that positive FDA Type C outcome for amsulostat, it supports the next phase of execution of moving towards that trial. The placement received very I was delighted to see the strong support we got from both existing and new institutional and sophisticated investors. The SPP will be open to all eligible shareholders in Australia and New Zealand, the issue price on the deal was AUD 0.027, which was around about a 15% discount on the day compared with the price it last traded at. From a shareholder perspective, you know, what we see then is extending the cash runway to through to quarter three 2027 with that AUD 8 million placement. It funds five key clinical trial readouts across this calendar year, and supports the ongoing licensing discussions that we're having across that pipeline as well. Every single data point we get from a pipeline asset reaching those clinical efficacy and things is not only a clinical endpoint, but it's also a potential commercialization point as well. It supports the phase II-B study, so it will be used to finalize the protocol, select CROs for doing the study, site negotiations, formulation work, and clinical trial supplies. Also we, as I mentioned at the beginning, you know, we are in a very strong position with our pan-LOX drug being a first-in-class and best-in-class, and we aim to strengthen our patent suite as well to make sure that we defend that well, and that, you know, under-underscore the value of this for any potential partner coming in. Objectives for the overall raise was clearly to fund the clearly defined near-term milestones, position the company to deliver shareholder value through clinical and commercial progress that we expect to see within the runway that this capital raise gives us. With that, I will stop, and Matt, I'm very happy to take any questions that we have. Thanks very much, Gary. Yes, as a reminder to the audience, if you have a question you'd like to submit, please do so using the Q&A panel within Zoom, and I'll jump into those now. Gary, a good segue from where you finished there. There's a question here just around, someone being surprised at the timing of the capital raising. Mm-hmm. I mean, this question's also cited that a view that going to phase II-B rather than phase III they thought would have extended the runway. Do you just want to comment on the timing and that point as well? From a timing perspective, I think, you know, we wouldn't have expected that the announcement of a sort of an FDA approval to our phase II-B protocol would have in the markets as they exist today, would have seen much appreciation in the value of the stock at this time. Despite that, it was clearly a step forward for the asset and removed a lot of risk. We thought it was an appropriate point to raise capital on that. It gives all of the investor base and the people coming in on this raise as well the opportunity with that extended runway now to see the advantage from the number of endpoints and news flow that we have coming in the next 12 months. Whilst it was, you know, we could have waited a little bit longer and delayed it until we had an outcome, say, from the Parkinson's disease study later on this quarter. You know, that's a placebo-controlled study. We don't know whether that will be positive or negative as yet. From a prudency point of view, we felt from a timing and for the existing shareholders, the best thing was to do the capital raise on the basis of removing the uncertainty around the pathway for amsulostat and allowing then everybody to benefit from the news flow that's coming within the extended runway that we have. Matt, what was the second part of the question? It was just with regards to going to phase II-B rather than phase III, should that have extended the runway? I should be clear that, I mean, this capital raise does not fund the phase II-B study. It gets us to, you know, it's very important for the company now that we have with this FDA approval, or agreement to the protocol, with us and the de-risking of this pathway. We're now clear to engage with the companies that we've many of which we've already had three or four discussions with about whether they see commercial value in talking to us now, ahead of starting the phase II-B. You know, the board of Syntara has said it will explore both the potential commercial value of amsulostat as an asset now and also the interest from investors in investing in a phase II-B study, which would start later on this year. Phase II-B or phase III, I think, you know, the value of the asset at this point in time is the same whether we were starting a phase II-B or a phase III. We are selling it. We would be partnering it on the basis of the existing data and the pathway that the FDA have laid out before us. I believe also that any potential partner looking at our drug, a phase II-B study would be probably their preferred clinical pathway route rather than jumping straight into a much larger phase II/III study, where there were more uncertainties about the endpoints and agreeing the endpoints before you got to the phase III. I think what we have now is an appropriate pathway forward, an agreement from the world's largest and most significant regulator over something that de-risks the asset and will encourage companies to take a very close look at the data package we have and the plan to progress it from this point forward. Thank you. Another question was, can you shed any light on the new institutional investors coming in? Are they specialist healthcare funds, et cetera? Yeah, I think, you know, it's always been a strength of Syntara, the depth of specialist healthcare investors that we have. In the stock, I would say that remains more or less the same post this raise. We had very strong support from our existing shareholders, and we have some new institutional money in and some washing backwards and forwards. Overall, I would think that the amount of support is similar. Again, a lot of the money coming in has been from sophisticated investors who understand the healthcare space extremely well. The next question is TSS is subjective. Spleen size is objective. To what degree might the placebo effect impact the result in a blinded study? One thing you should, you know, the spleen size is an endpoint that's there because it's the one thing that a JAK inhibitor does well amongst all others. It, you know, I've faced this question a lot in terms of, oh, should it be SVR25? Should it be SVR35, 35% reduction in spleen volume? The FDA were really clear with us that what they want to see are endpoints that are meaningful for patients and are relevant for the mechanism of our drug. There will be in the secondaries lots of hard endpoints in with blood volume, with the spleen size and with blood counts, for example, even overall survival in the secondaries. The primary endpoint is TSS50. Within the TSS50, one of the domains is abdominal discomfort. You know, a lot of the significant symptoms that patients suffer from are as a result of spleen volume. You wouldn't expect to see a positive TSS50 unless you also saw a reduction in spleen volume. I take the point that they are that, you know, that this is a patient-reported outcome and therefore could be seen as being subjective and that you will see a potentially a placebo effect. That's why it, you know, we size the study the way that we have. We believe that the number of patients we have in will overcome any placebo effect that we see. We've looked at earlier studies with other drugs in myelofibrosis and looked at the size of the placebo effect on symptom score in those, and we've adopted that in terms of saying assuming that we would get the same or slightly bigger placebo effect in our studies when we thought about the powering of the study going forward. It's a, it's a good question, it's a relevant concern, but it's one that we've taken into full account when we're thinking about the design of the study. As I said, spleen volume, albeit measurable, doesn't necessarily lead to, you know, a really big impact with either clinicians or. You know, spleen volume isn't measured when you go to the clinic with for myelofibrosis to a hematology clinic. Lots of the drugs which are now struggling a bit in development, ones that have fallen over quite recently, have been where they've seen quite strong spleen volume reduction, but they haven't managed to achieve symptom score improvement, not in a significant way. Our drug again stands out because of that really significant... You know, the thing which really hit the most is the TSS50. That's giving us a lot of confidence going into the next stage, and it's an attractive thing for potential partners. The next question is: What would you say is stopping big pharma companies from partnering with Syntara at this stage? What would you say they are looking for in particular? I don't think there's anything. I mean, the thing that was not stopping them, but one thing that would that gave them reason to wait a bit longer was the fact that we hadn't had an FDA review of the phase II-A data and an agreement on the appropriateness of the next step. We've now got that. I think we've removed one of the main hurdles to those commercial discussions that we aim to have in the, you know, in the next period. It's, there's. You know, other than that, the thing that would stop engagement is we want to see more data. Now, there's a breadth of companies that we talk to. Sure, you know, some of the really large companies, you know, they can afford perhaps to sit back and wait and see what happens and say they'd like to see more data, and they're not comfortable with the level of risk of taking on a drug which is going from phase II-A to phase II-B. But there are many other companies who see this as an opportunity where they can get involved and pick up because of that perceived increased risk of taking something when it's got earlier data. I, and I wouldn't say that our drug is early stage either, right? I mean, it has phase II-A data. It's already completed phase I. It's got phase II-A. We have data in patients. We've got a lot of safety information in patients, and we've got an FDA review of the data package as well. I think we're now in a good spot. Related to this, someone else asked, how mature are your discussions with a potential funder for the phase II-B trial, and how much will the trial cost? The phase II-B study with 100 patients is in the order of $20 million-$25 million. Clearly, you know, from a market cap of AUD 50 million, that's a big chunk of money to find to fund the study. You know, again, I just point to the fact we're a company with multiple milestones ahead of us, lots of opportunity for value increase in the stock, and also, collaborations, potential collaborations with partners, not just over amsulostat, but over other drugs in the pipeline as well. Relative to a company that has one asset with one indication and one trial running, what you're looking at here is a company with multiple assets, multiple indications, all of them funded within the cash runway that the company has, and lots of opportunity for value appreciation coming up, and not only from just stock market realization of value as we present clinical trial data, but also from potentially non-dilutive funding coming in from any of the assets that we're talking about today and what we can do in terms of commercialization of them when we've got the data which is coming up again within the runway of the cash that we've got now. Thanks, Gary. That's all the questions in the queue, so I'll just hand it back to you to provide a concluding comment. Thanks, Matt. Well, again, very much appreciate people's time on the call this morning. You know, there was a lot to get through, but that's, I think, what you get with Syntara, right? You have a company with a pretty mature asset that's de-risked now with phase II data and a regulatory path forward from the FDA, and a number of other assets running behind it now with clear value points coming up within the cash runway that we got after the capital raise. I'd like again to send my appreciation to those people who supported the recent capital raise. I look forward to updating you all as we go through the rest of this year. Thank you, Matt.