Syntara Limited (SNT.AX) Q4 FY2025 Earnings Call Transcript & Summary

Good morning, and welcome to Syntara's Investor Webinar and Q&A following the release of the company's quarterly update. Presenting today will be CEO, Gary Phillips. [Operator Instructions] I'll now hand it over to Gary.

Thanks, Ben, and good morning, everybody, and thanks for sparing your time on a Friday morning. That's much appreciated. So I'll just -- my presentation this morning will be relatively short. I'm very happy to go into Q&A about any of the topics that I've got here. But it was actually quite a nice experience writing going through the quarterly review this time and summarizing what we've done because I think it was a big quarter for us in terms of building momentum around both our key asset and some of the pipeline stuff as well. There's a huge amount of value that we're putting into the bank at the moment, waiting to withdraw at a later point as these things start to come to fruition. So let me start on the key asset, amsulostat and talk about what we achieved in the quarter -- post the end of the quarter as well, really, it's carried on. So the first thing is just to remind you all that amsulostat is actually SNT-5505 that we used to refer to. So we got the WHO, the World Health Organization, granted us the -- what they call the international nonproprietary name. I think most of you would know it as the generic name. If you go to a pharmacy and they ask you, would you like the generic? They give you the generic name. So -- Panadol is paracetamol, and we don't have a brand name for amsulostat yet, not a name that we take to market as a brand name, but the generic name of it, the official name is now amsulostat. That's a marker also of progress because they don't grant that until you've got a significant amount of evidence and data behind it before you come out with it. So it's an administrative thing, but it's also a mark of a step of development in a drug program as you get forward to commercialization. Secondly, we have the FDA grant us Fast Track designation for the treatment of myelofibrosis. Again, that's the result of a submission from the company with a considerable amount of data and evidence behind the drug that it will be useful for patients with myelofibrosis, and it deserves to be singled out because it's bringing something else to patients than is currently available. So it's a recognition of that and obviously grants us certain privileges in terms of numbers of meetings we have and timing of reviews and things. So that was a mark of validation of the program as we go forward. And then I guess the highlight of the quarter was us presenting another set of interim data from the Phase II myelofibrosis study at the European Hematology Association Conference in Milan in June. This followed on the back of the interim data that we put out in -- back in December at the American Society of Hematology. And after this summary, I'll just give you one slide just going through a review of those results that we presented there because it is critical, I think, that we all understand where we're up to? What the data looks like and what the competitive profile of the drug is that it's emerging from this data? An important step in the development of amsulostat is also that we believe that it has potential outside of myelofibrosis and in other hematological conditions such as myelodysplastic syndrome or often shortened to MDS. MDS is a larger market than myelofibrosis. It's very poorly served at the moment. Patients with MDS do not have a wide range of drugs available to them. And the ones that are effective, again, are pretty poorly tolerated. So there is a large need for new drugs in this area. And of course, we're delighted that we got nondilutive funding from the German Cancer Fund to put forward this study called AZALOX, which is a study of our drug in high-risk MDS patients who are taking a hypomethylating agent, in this case, 5-azacitidine. So that study is just kicking off with the first site initiated. There will be 9 sites in Germany covering this with a proper contract research organization managing it. So it's a really important study and is due to deliver some data by the middle of next year. So in terms of coming together with the program on myelofibrosis, the timing of this is excellent. And I guess on the back of that, in June, I and one of my colleagues went to the biopartnering conference in America. It's the largest partnering conference that takes place each year. And we had strong interest in amsulostat at that partnering conference. And we're getting strong interest because of the stage the drug is at. And that is coming to the end of its Phase II program and looking like it's ready to go into Phase III. And that step from Phase II to Phase III is the subject of a Type C meeting application that we lodged with the FDA once we had the data -- last interim data update in June. And we're there with the FDA to discuss the clinical development plan for amsulostat going forward, and I'll come back to that in a moment. So overall, it was a really busy period for amsulostat with very positive -- both validation of the compound and the drug program from WHO, the FDA, great feedback from opinion leaders at the European Hematology Conference and at the biopartnering conference. There's a lot of interest and that data coming through, but then also adding on additional indications as well. So can't express how excited we are going forward into this next quarter with the progress that we've made and that we hope still to make. On top of amsulostat, going into all those points above, we also started to move into gear with our skin scarring program. It was just over a year ago that we announced positive data from a topical pan-LOX inhibitor, SNT-6302, treating scars, in this case, established scars -- scars, I think, at an average age of 13 years. And we demonstrated that we could reduce the amount of collagen in the scars by 30%. And then subsequently in a subgroup, we also showed revascularization of the scar tissue, showing that we are beginning to normalize the skin within the scar itself. So that's really given us a lot of encouragement. It's a huge validation of the concept that we have. And it was great to see in this last quarter, 2 studies initiated, one of them with our next-generation pan-LOX topical treatment, SNT-9465. That's going for the treatment of hypertrophic scars. We dosed our first patient earlier this week in a Phase Ia/b study. So the first part of that is in healthy participants where we're checking on the penetration of the drug into the skin. We're looking at levels of enzyme inhibition in the skin, systemic circulation as well. And then after that, we've gone through -- making sure that we've got the dose right on the skin that will go into a study looking at patients with hypertrophic scars to see if a 3 months treatment will improve both the appearance and the functionality of the scar and the skin around it. At the same time, the long-term collaboration we've had with Fiona Wood took its next step, and they're exploring the use of a pan-LOX inhibitor, in this case, the first-generation compound 6302 in the treatment of keloid scars. And together, keloid and hypertrophic scars make up a market which globally is worth more than $3 billion annually. It's an extremely -- an area where there's very little available treatments, and we're one of, if not the only pharmacological treatment for scars that's currently in the clinic working towards trying to find out a treatment for these patients that have scars. And of course, there are millions and millions of patients each year, which have scars, which need some kind of treatment. So really, really excited again to see this whole skin scarring program, as I put here, moving into gear and starting to move forward. And then last but not least, great to see that the recruitment in our sleep disorder, iRBD/Parkinson's disease Phase II study since we've opened up the center in the U.K., that's now recruiting strongly. We're more than 50% recruited now, and that's on track to both fully recruit by the end of the year and then report in the first half of 2026. So just as a reminder, that study is a placebo-controlled blinded study in 40 patients. What we hope to see out of that study is 2 things. One is, is the drug able to improve sleep quality and several other sort of sleep parameters in these patients. And then secondly, we're looking at inflammation in a particular area of the brain, which is associated with the development of Parkinson's. So an exciting study in its own [ right ], never mind everything else that we've got going on with data coming in the first half next year. And then last but not least, we finished the quarter with a strong cash position. So we finished the March quarter with $18 million, this quarter with $15.1 million. So historically, we are burning around $1 million a month. So just going back to that data from amsulostat in the European Hematology Association, the last lot of interim data we presented. So I think in summary, the -- what we're seeing overall is a drug which has a competitive profile when you look at it against the context of what else is available to patients in myelofibrosis and what's in the development pipeline. We believe from a safety perspective, we have a class-leading drug. We have seen no serious adverse events that are drug-related in this study -- ongoing study at the moment. That does stand out distinctly against other drugs which are in development. And of course, if you're going to use a drug on top of a JAK inhibitor in these patients, in our study have been treated on average for 3 years and are considerably symptomatic. Then, having a drug which you can add on and you don't add to the burden of those patients with any side effects is a huge bonus for both clinicians and patients. And then from an efficacy point of view, we have seen a really standout result in symptom score improvement. The bar here is a 50% improvement in symptom score in order to call a patient a responder. And we've got more than 70% of our patients in the study at 6 months and beyond are responders. They're getting more than 50% reduction in their symptom score. And that compares very well when we look at Phase II open-label studies of drugs that have been in development and not yet on the market, which are getting around between 30% and 40% of those patients who they can call responders on symptom score. So that was very reassuring to see that improve further beyond what we presented at the American Society of Hematology in December. So again, really reassuring to see that. And it's quite a unique finding that these patients not only improve at 6 months, but continue to improve when we look at them beyond 6 months. And then finally, on the efficacy point of view, we saw also a really good improvement in spleen volume. So these patients, despite being on ruxolitinib for a long time, still had spleen sizes, which were significant. And we saw more than 40% of the patients get a 25% improvement in their spleen volume -- 25% in reduction in their spleen volume. As a reminder, the 2 endpoints that we believe the FDA will look for in this particular patient population, which is patients on ruxolitinib were suboptimally controlled will be a TSS50 as the primary and very likely SVR25, so a 25% reduction in spleen volume as a secondary endpoint within the study. So we're now -- the next steps with amsulostat in myelofibrosis are 2 things. One is that we expect this quarter to report on the final patients completing 12 months treatment on the drug. So those are going through now. And then secondly, to get some guidance from the FDA on progressing to a pivotal study. So on the basis of the data that we had, we submitted a Type C meeting request to the FDA, which they granted, and we expect to get feedback from them on a series of questions, one of which is, is our safety package of the drug suitable and enough sufficient to -- for us to go into Phase III from where we are now. And then we've given them a high-level view on what we believe the Phase III study will look like, and we're asking for their guidance, particularly on the endpoints that we think would be applicable for the study. So those 2 things are really important updates that we expect to have this quarter. So a really encouraging point in the development of amsulostat, and we hope to get that validated from FDA feedback in the near term. So just a reminder of the overall pipeline, amsulostat in myelofibrosis and MDS, data coming this quarter and then MDS data coming by the middle of next year for the MDS studies of which there are 2. The scarring, the 2 studies there, the hypertrophic scars, the one being run with the next-generation compound 9465, we expect data around the middle of next year as well. And then finally, the 4728 in iRBD and Parkinson's disease data by -- again, in the first half of next year. So a busy next quarter with the key thing being that final data and the outcome of the FDA review with the Phase II/III clinical trial proposal. And then lots of potential shots on goal in the first half of next year with those studies reporting out. So with that, I will end my presentation, and I'm very happy now to take any questions that we have.

[Operator Instructions] Just we had a few questions coming through regarding amsulostat, sorry, also known as SNT-5505. First one, when will you be -- I think you've already covered this, but when will you be releasing data for the final top line Phase II?

Yes. So the -- there were only 3 patients data at 12 months that was missing from the interim update that we gave in the European Hematology meeting in June. Those 3 patients will complete this quarter, and we do expect to release the top line data from that by the end of this quarter.

Can you share any updates or strategic plans regarding the commercialization and potential partnerships for SNT-5505, particularly in light of the recent positive Phase II interim clinical data and FDA designations.

Yes. So I think as I mentioned in my presentation, we are interacting with potential partners who are interested in hematology and hematological cancers. We do have an asset which at this point, with positive Phase II data and upcoming guidance from the FDA on what they believe to be the status of the program and its ability to be going forward. It's clear that at this point, this becomes an interesting asset for those companies that we're talking to. We talk to companies at the hematology meeting. We talk to companies at bio. And I think overall, the feedback I can give at this particular point in time is that they all see the outcome of the Type C meeting with the FDA as being a pivotal point for them in terms of confirming their interest in the program going forward. And if I just -- I think I've got -- maybe I've got one slide here I can share just to sort of indicate what we're trying to do here. So this is a slide which shows the last 4 deals that have been done in myelofibrosis since 2022. The 2 columns over on the right-hand side, pacritinib and momelotinib are both JAK inhibitors. Both of them work like ruxolitinib, but in a subgroup of patients. So pacritinib is used in patients who have very low platelets. Momelotinib is used in patients who have myelofibrosis, but also have anemia. Pacritinib is used in a relatively small percentage of the market. Momelotinib has captured a fair degree of myelofibrosis patients since its launch. But both of those were acquired after Phase III data, pacritinib for $1.7 billion and momelotinib for $1.9 billion. So those are the kind of values that we saw for a [indiscernible] JAK inhibitors with a slightly different label than the existing ruxolitinib. The column in the middle, pelabresib, that was a MorphoSys drug bought by Novartis. This is probably the nearest competitor to amsulostat that we see in that it was a drug that was going to be used on top of ruxolitinib, so in the group of patients who are suboptimal. They were trying to position the drug as a -- to be used alongside a JAK inhibitor. So you would prescribe it for patients with ruxolitinib when they were diagnosed and needed a JAK inhibitor, so maybe slightly earlier. But this drug, which had in Phase II spleen volume reductions similar to a bit less than we've shown in our study and a TSS50, I think, of just under 40%, and we've shown 70%. This drug was acquired by Novartis in February '24 after Phase III for $2.9 billion. So it just shows the level of commercial interest in this particular area in this market. And of course, there have been some problems with pelabresib since then. There's been a safety issue that's emerged. Novartis wrote, I think, $800 million off of their balance sheet asset value of the drug because of that safety issue and the plan to go to the FDA has been put on hold whilst they've explored the data further. So we believe that this market is opening up for us. This is the one drug we saw ahead of us that would be a potential competitor and has a question mark over it, but also puts in a good marker in terms of value for the market of Phase III. The drug on the left from Keros that was bought by Takeda is interesting because it was acquired after Phase II, so much more similar to where we are now. That had ongoing trials actually in both MF and MDS. So the parallels are there. I think they had some data in MDS where we don't have that data yet, but it's coming. Takeda acquired that for USD 200 million upfront and the total deal value of over $1 billion. So again, there is optionality here for the company in terms of exploring commercial value for the asset, both now and after Phase III as well. So it is our intention to move forward in a parallel fashion and explore value of both options, both of partnering and of exploring going into Phase III.

Yes, we do have a question regarding how long it will take for the Phase III trial for myelofibrosis to run for. So anything further to add there?

So a Phase II/III study in this particular area is we're looking, we think, around about 300 patients. Recruitment for that study is around about 18 months in length. This is an orphan disease. The patients are quite rare. So it's about 18-month recruitment time. And then the study itself would run for 6 or more months. So you're looking at a 2- to 3-year period for running a Phase II/III study for this kind of drug.

A few questions regarding the -- sorry, the lodgment of the quarterly being late. Why the -- question was why did the company missed the deadline and what's been done to prevent this from happening again?

Yes. that's embarrassing. Well, as you can see, we did lodge our quarterly update with the financials in it -- back earlier in the week. But at the same time, the 4C that goes alongside that due purely to an administrative oversight and miscommunication didn't get filed at the same time. When we realized our error, we filed it immediately. We were 30 minutes beyond the deadline. And at the moment, the -- which is -- it was filed it before the end of July 31, but the deadline that the ASX now use, I think, is 8:00. So we missed that by 30 minutes, and that's an automatic 1-day suspension. It is unacceptable, put a hand up. We've reviewed our internal procedures to make sure it doesn't happen again, but it was a simple miscommunication that meant that we filed the quarterly update just without the 4C tables alongside it.

Patient numbers between 250 and 350 have been mentioned. Given the relatively large efficacy signal, the minimum number may be driven by safety, can you give your perspective on what would be a positive FDA outcome on numbers?

I'm not sure I fully understand the question, but I think the question is right that the -- if we saw the same kind of improvement in TSS50 in the Phase III study, you wouldn't necessarily need 300 patients in order to get a statistically significant effect. However, the size of the Phase III is driven by the minimum safety database the FDA require in order that they've got enough safety data to find -- to approve the drug. So it's not just enough to show efficacy. They need to see a minimum number of patients exposed. And we think -- and that exposure includes all the patients we've already studied in the monotherapy patients that we reported in '23 and the Phase II study combination drug that we're showing now. So those 2 things together add to the safety database and you add them on to the patients in Phase III. So altogether, we think 300 patients now is what you would need to get to that point.

How much capital would be needed for the Phase III trial?

The Phase III study of in the order of USD 80 million is about the cost of doing a Phase III study in this area.

Just [indiscernible] a lot of positive talk regarding interest in Syntara's drugs. It's not being reflected in the share price. What is the company doing to promote this positivity outside of quarterly updates?

Yes. We're -- I personally, am spending a lot of time attending conferences, meetings. I've just done visits to shareholders in Melbourne, Sydney, Perth. And I've got plans later in the year to go up to Asia as well. So there's a lot of effort going into promoting and educating people on the stage that we're at. At the same time, I think we need to reflect on what's happened in the quarter as well with the share price. I mean we -- the stock was trading well from -- up from the raise that we did in December last year when we raised at $0.06. The release of the positive data in Milan at the European Hematology Association meeting, the response in the share price was severely dampened by one of our shareholders, BVF, exiting its stake, which was 5%. And that was an off-market trade at $0.045. So since that's gone through, the stock has traded steadily up on the back of what we're doing. And I think the update we've given today and the progress we've got across the portfolio will hopefully continue to see that good steady growth in value -- in market valuation as we go into this next quarter where, again, we have more validation and endpoints, which we think will drive shareholder interest -- investor interest in what we're doing. And just reflecting a minute, that trade from BVF. I mean they were a long-term shareholder. It was disappointing to see them leave, but they are a $9 billion fund. They had an investment in us, which was worth about $5 million. So we were a very, very small percentage of their portfolio. They only had one other investment in Australia, which was in Actinogen. They exited that a few months beforehand. So they were clearly going through a process of clearing up. I've spoken to the fund manager at BVF and he went to great lengths. I know him very well for many years. He confirmed to me that this was them clearing up. And they still have interest in us as a company, but that interest will not be driven either positively or negatively whether they had a $5 million investment or not, which they needed from an administrative point of view to clean up. So I'm -- yes, I understand where the question is coming from. I'm very aware of where we stand in terms of a market cap and the development we've got. And I think there is a disconnect between the value of the programs the company is progressing and the amount of progress we've had, the way we've managed to raise a lot of nondilutive cash actually to keep a pipeline going, which is significant and all of them reaching significant Phase II milestones with data, which can transform valuation. And I think that's what I focus on. So it's the amount of investments we've made, the efficiency with which we've done that and the opportunities that we've created in the next 6 to 12 months for generating further value, and we'll keep on promoting that and educating people as much as we can.

Thank you. That concludes the Q&A segment. I'll now hand it back to Gary for closing remarks.

Okay. Well, thank you very much for your time. I hope you find that interesting. I think it's a really exciting moment in the company's life, as I said, just in that last question. We have got a lot going on within the company. We have a pipeline which is advancing well, and we've got positive data coming from our lead asset, which is going to drive interest not only from investors, but also from potential partners as well. So I look forward to reporting further progress later in this quarter and in particular, on the outcome of the FDA Type C meeting and the final data from the myelofibrosis Phase II study. But thank you for your time.