Syntara Limited (SNT) Earnings Call Transcript & Summary

Thanks for standing by, and welcome to the Syntara Investor Webinar and Q&A following the release of the company's Appendix 4C quarterly for June 2026 and other recent announcements around SNT-4728, as well as the skin scarring and myelodysplastic syndrome programs for amsulostat. There will be an initial presentation for approximately 10 or 15 minutes, after which we will take questions. If you have one you'd like to submit, please type it in using the Q&A function within Zoom, and we will get to those at the end. To kick us off, I will hand it over to CEO of Syntara, Gary Phillips.

Thanks, Matt, and thank you all for joining this morning. Usual disclaimer. The June quarter. Yes, a really good quarter, actually. Sometimes when you are in the thick of things, you do not always sort of recognize what is going on. But it is actually this is a really useful point when you are sort of updating on the quarter, trying to write it up and listing the things that were progressed in that period. Reminds you of how much actually happened. In this case, at the beginning of the quarter, we had that positive FDA feedback on the clinical development pathway for amsulostat and myelofibrosis. We presented the update and the results at ASH in December last year, and this was the logical next step in presenting the full program to the FDA. We sent a full team to Washington and prepared well for the meeting. I think we lined up a good set of advisors as well that helped us think through how the FDA was approaching these kind of meetings and what were the questions we are going to have. In the end, we had a very collegiate meeting with the FDA, with broad agreement across the spectrum in terms of the way forward for the drug, and led to a protocol for a phase II-B study with myelofibrosis, which has de-risked the asset in that everybody now looking at the asset can see there is an agreed way forward. Any questions the FDA have been answered, will be answered by the study that is in place. It gives us certainty about what we do next. On the back of that, we did an institutional placement, put $8 million into the bank balance. Important, because that extended the cash runway through to FY '28, the second half of next year, calendar year. Given how much the news flow, as I will come to at the end of this presentation, is stacked during those 12 months, it really gives reassurance and confidence for the company that it has got the cash it needs to see it through some very important clinical development endpoints that we are going to see. It all came as a rush at the end of the quarter, just after the end of the quarter in most cases that we had other progress to report. I think the 4728, I've got one slide on that just to sort of show you, those of you that didn't join with the webinar where we had Professor Simon Lewis talking about the study and what had been achieved with the primary endpoint readout in that study. Some of the long-term expectations for that drug based on this result I think are important to just recap briefly. Importantly, the skin scarring trial in hypertrophic scars with now our lead asset in the skin franchise, 9465. 60% recruitment earlier this month. Well on the way now, we're expecting to see that recruitment completed by the end of this quarter. Finally, the AZALOX, which is another study going for amsulostat. This is alongside the myelofibrosis program that we have. There's a myelodysplastic syndrome, another hematological malignancy, where we're in a dose escalation phase I-B study. It goes into a phase II study. This is the study that's happening in Germany. It is an investigator-led study, but with 10 centers in Germany active now and recruiting. It was good to see that first cohort, the first dose completed, no safety concerns and the treatment moving on into the second cohort. Multiple catalysts ahead of us, I just wanted to spend a little bit of time just talking about a little bit more of the detail on some of those highlights. First of all, just to recap on the cap raise that we had. Just great to see our major shareholders, D&A Income, followed their money in this raise and stayed at 18%. Platinum Investment actually went over their allocation and increased to 12%. Total institutional ownership of the company is sitting around about the 44%. A lot of that is specialist healthcare investors. Very grateful for the coverage we also receive for the company from Canaccord, Euroz, Bell, and Evolution Capital. All with which gives shareholders, I think, great insights into the company, the progress, the plans, and the timelines of what we're trying to achieve. Really, I think if we now think about Syntara and the value that's there, we can distill it now into these three assets and these three programs. Obviously, there's the key one, which is amsulostat, in two areas of very high unmet need, significant market opportunities with now clinical proof of concept in a phase IIa and an agreed pathway forward from the FDA and more data to come in an additional indication. All of which makes that asset very attractive. The skin scarring program, where we have our 9465 going forward in a hypertrophic scar. Well past 50% recruitment now, we're expecting to see results on that by the end of the year. The Parkinson's disease program, which has delivered positive data earlier this month. Really quite, I think, encouraging. I have personally been quite affected by the number of Parkinson's patients and organizations that have contacted us since we've issued that data. I don't think I had quite sort of gathered into just how few drugs are actually being looked at in early Parkinson's, and in fact, no drugs at all in iRBD, one of the leading prodromal diseases where patients go on to develop Parkinson's or Lewy body dementia afterwards. Really nice to see that result there. I'm sure that as a recap, we feel we have a really competitive profile. We have a drug which, from a symptom score improvement, seems to have done better in open label phase II studies than other drugs which are still in development or drugs that are on the market at the moment. That's a key area. It's clearly a very important aspect for both patients and clinicians. The fact that we've seen such a positive result from this that it improves over time and it goes out beyond six months where most of these myelofibrosis studies stop, I think gives us a good feeling about the drug being differentiated from the competition. We're competitive on spleen volume reduction, and great to see patients continuing on drug at the end of it once they finish the study. Now with that FDA review behind us, a clear pathway forward. Why is that important? This slide is getting busier and busier. I've shown this slide before, it used to have four company deals on it, two of those I've actually taken off because they're a bit older now. The ones from Sobi acquiring pacritinib from CTI and GSK acquiring momelotinib from Sierra Oncology. Both of them JAK inhibitors. The market continues to be giving us very strong feedback that there's a lot of commercial and clinical interest in myelofibrosis in assets here. In recent months, we've seen from the different kind of JAK inhibitor with Lilly picking up Ajax. Ipsen recently acquiring Kartos, which is a drug with a different mechanism of action, navtemadlin in myelofibrosis, which is in phase III now. Drugs that are a bit ahead of us in the marketplace. It's important to think about where do we fit, where does amsulostat fit in this? Do we have a competitive program, and what is likely to be the interest in the asset and what we're doing with it? Takeaway from this slide is just still huge amount of commercial interest, big deals going through in an orphan disease where there's clearly a very high unmet need. What I'm just laying out here is what we see as the future of amsulostat, and where it will be positioned, why it's of interest to strategics like the companies on the previous charts, what we're currently talking to them about. On the left-hand side, we've got the current trial and the development path, which is positioning our drug on top of a JAK inhibitor in patients who are not well-controlled. Now, if you think about the trials that have been done with JAK inhibitors in an earlier stage, when they're used in a naive sense that patients take them for the first time, about 40% of patients respond to them in an adequate way in a clinical study sense. Probably a bit more than half if you take it out to the wider clinic sense. Many of them, just under half maybe, even from fairly early on, are not really responding that well. They still have room to improve. There's a market opportunity here. If you think about the market for JAK inhibitors in total as being around about sort of high $1.8 billion, $1.9 billion, $2 billion in terms of sales in myelofibrosis with the JAK inhibitors combined. The opportunity for drugs which will add on to that, particularly with ruxolitinib coming off patent in 2028, is around about half that. About $1 billion. We have a drug which is endorsed the clinical development pathway for that particular indication. The label is now endorsed by the FDA. We've got a very favorable tolerability, a unique inhibition mechanism tied in with that we think distinguishes the drug from everything else that's in development. The mechanism in terms of its ability to inhibit PDGFR signaling, we think is really enhancing the impact on JAK inhibitors on cell proliferation. If you remember back, we were actually quite surprised to see the impact on symptom score pretty early on in the study. We expected to see it six months and beyond, we actually saw symptom improvement from three months, which shows there is something going on particularly with the JAK inhibitors, which we think is worth a lot in this particular area. That potential to improve symptoms and extend the useful treatment duration of JAK through the effects we're having on the bone microenvironment through that fibrosis and effect on PDGFR signaling, we think puts us in a really strong position in that particular market. Beyond that, we believe that because of amsulostat's very clean tolerability profile, it doesn't have a hematological toxicity associated with like a lot of other drugs that are in development. We believe it's got a place much earlier in the disease as well. Any company that's interested in amsulostat and developing it going forward, we're really making the case that it's not just in the suboptimal group, but also in the group where you're using JAK inhibitors for the first time. We think that it's got a place there. The market opportunity here is larger, obviously because you're using it earlier in wider numbers of patients. Even beyond that, on the far right-hand side, once patients are first diagnosed with myelofibrosis, at the moment, they can't do anything with them. Patients are basically told to wait until their symptoms and their spleens get larger, then they become eligible for using a JAK inhibitor. The JAK inhibitors aren't used straight away because they do have safety problems, they do cause patients to deteriorate in terms of their cytopenias. You wouldn't want to use them until the patient needs them. There's an opportunity here to actually use the drug earlier in case. These are all different development paths. They take longer to do, but they are potential for the drug. They are, when we map the future out, reasons why companies would be interested in picking it up because of its unique profile, its safety positioning, its ability to, we think, be disease-modifying. Lots going on with amsulostat. The other drug which produced data in this month was the 4728, reducing inflammation in the brain. This is a study fully paid for by Parkinson's UK, a philanthropic organization. All of its money comes from donations. They really got behind this study with the support of the Parkinson's community. It was an ambitious study, a technically challenging study. We don't believe there are any other drugs being tested at the moment, trialed in patients with iRBD with this kind of outcomes looking for. We've spoken even since this data's come out with a number of clinicians who were openly admiring the ambition of the study and the data that we're collecting. I think it's worth saying again, these are patients which have a sleep disorder. It takes them sometimes five, 10, sometimes even 15 years to transfer to becoming a fully blown Parkinson's patient with all the symptoms that we associate with that. So to see in three months treatment a statistically significant impact on an area of the brain which is directly involved in those motor symptoms of Parkinson's disease that we're all very familiar with is a highly significant result. 20 out of the 30 patients that we had had that improvement as shown on the line chart on the left-hand side. It was really great to see that change in a short period of time. We're waiting to see the rest of the data, which we expect to get later this quarter, towards the end of the quarter. At that point, we will be engaging in discussions with the global philanthropic organizations about what the pathway forward for this drug is. We're also talking to companies that are CNS specialist companies that are as interested as others are in the mechanism that we have and the potential to treat these patients earlier on and perhaps slow progression to Parkinson's and also treat iRBD, which is in itself a very high clinical unmet need and a commercial opportunity. Finally, the skin scarring study, which we announced as 60% recruitment. Just to remind you, what we're dealing with here are scars which are hypertrophic. They're clearly enlarged. They're not a normal scar. We're using sternotomy scars because they're all identical scars in these patients that we're recruiting. That gives us a chance to treat one part of the scar with active therapy, one part of the scar with a placebo, with a buffer in the middle. We're looking at a host of endpoints including rating the scar from high-resolution photographs from 3D imaging, looking at the volume of the scar. We should see if the drug works, the volume decreasing. With OCT, which is looking at the vascularization of the scar, which was positive when we used an earlier generation drug in patients with very old scars, if you remember. Also elastography, so looking at the pliability of the scar. We think the scar should get softer if we reduce the amount of cross-linking there. As well as patient and observer-reported outcomes as well. A very innovative study, I think. I think it's a smart study. I think it's the right study to do. With the recruitment now well underway, we're looking forward to seeing the impact of our drug on that as the way goes forward. Just concluding with then the news flow for the second half of the year. Amsulostat is we are getting ready to start the phase II-B study at the end of the year. We do not have the cash to start that study in the bank. That's not the strategic plan of the company. We are exploring at the moment potential collaborators, both from a strategic point of view and also from an investor point of view, to think about how we might get that study going. We are preparing for an end-of-the-year start. The clinical trial supplies, the GMP material for that study is underway. We're already having discussions with contract research organizations about where the study would be, what centers we would have, and again, negotiations on the contract that would be behind that. I just want to make that clear that that study is something that we're gearing up to start by the end of the year. At the same time, those MDS studies underway, looking to see some interim data by the end of the year from the dose escalations findings in those studies. We announced earlier on that the Garvan had attracted an $3 million grant to do a pancreatic cancer study with amsulostat, and that's an investigator-initiated study. We're not exactly sure exactly what time of the timetable that's running to. There have been some developments recently in pancreatic cancer with other drugs which have shown efficacy and look like they'll be approved that might change standard of care. That's something that I know that our investigator is thinking about, is to make sure that the trial that is done there is relevant for the standard of care which is emerging at this point in time. The timing for that is to be determined as we've listed there. Skin scarring studies, the hypertrophic scar, this is the one that Syntara is running. We're expecting top-line safety and efficacy data by the end of the year. If that study is fully recruited by the end of quarter 3, it's a 3-month study, you will see data at the end of the year. That hopefully gives you a very clear and transparent readout through to when we expect to see data. On the keloid scarring, this is a pilot study that's being run by the University of Western Australia with Fiona Wood. That study is recruiting. It's very much a pilot exploratory study. We don't understand the biology in keloid scars as well as we do hypertrophic scars. It's one where we're hoping to learn a lot about how keloid scars form, what kind of collagen and cross-linking is within those scars, what kind of penetration we see from this, and this is our first-generation drug 6302, what kind of PK/PD we see in a keloid scar, which is different from the other scars that we've seen before, and then what kind of effect you might see over a period of time, and how long do you need to treat before you can see results. Again, hoping to see some efficacy and interim safety data on that by the end of the year. Lastly, that Parkinson's disease study where we've got the top-line data from the primary endpoint, that reducing inflammation in regions of interest in the brain, and the full phase II results we expect to see in the second half of the year towards the end, as I said, really at the end of quarter three. With that, Matt, I'll finish my presentation, and I'm very happy to take any questions that come up from the audience.

[Operator Instructions] I'll jump into those now. The first one, Gary, is how advanced are partner discussions aiming to fund the myelofibrosis phase IIb trial, and is quarter four start date still realistic?

That's a good question. In June I was at BIO. I would say our list of companies that we're talking to is narrowing as we see the interest in the stage of asset that we're doing. We have an asset with phase IIa data, and the big deals and big companies are happening with companies with phase IIb data, so one step on. I think the interest we're seeing is from the medium-sized companies. There is a lot of interest there. Those discussions are ongoing. We're also, as I've said on many occasions, exploring how we might fund the study, not through a strategic collaboration, but also with an investor route as well. That will play itself out in the next quarter. We are gearing up to be able to start that study by the end of the year. It is very much dependent, though, on the discussions we would have with potential collaborators or investors to make that happen.

On that note, a question that's just come through is what is the proposed cost of the phase IIb?

The phase IIb. As a reminder, the phase IIb study, as endorsed by the FDA, is a study of around about 100 patients. They'd be treated for nine months on drug. It is going to be a multinational study with a large number of centers. We're looking in the region of USD 20 million to USD 25 million to run that study.