SYNTARA LTD (SNT) - How Syntara Builds A Biotech Pipeline With Multiple Shots On Goal

A small ASX biotech can feel impossible to value until the data starts landing, and that’s exactly where Syntara is headed. We’re joined by CEO Gary Phillips to map out a tight run of clinical catalysts and the thinking behind a pipeline built around extracellular matrix dysfunction and amine oxidase chemistry, backed by specialist institutional investors and real in-house drug discovery.

We dig into Amsulostat, the lead program in myelofibrosis, and what positive FDA feedback actually means in practice: a clearer regulatory development pathway, a Phase 2B add-on design against placebo alongside JAK inhibitor standard of care, and stronger footing for potential partnering conversations in hematology and oncology. Gary also explains why safety and symptom score improvements matter so much at this stage, especially in diseases where current options can be hard to tolerate.

From there we switch gears into two more high-interest areas. In myelodysplastic syndrome (MDS), we cover the unmet need, the significance of grant-backed trials in Germany and Australia, and why indication expansion can materially lift an asset’s commercial upside. We also explore SNT 4728 in isolated REM sleep behavior disorder (IRBD), a sleep condition that can precede Parkinson’s disease, and how a placebo-controlled study funded by Parkinson’s UK uses brain imaging to look for reduced inflammation. Finally, we talk skin scarring, including hypertrophic and keloid scars, why function and mental health outcomes matter, and what a once-daily topical approach could mean if results stack up.

If you follow ASX biotech, clinical trials, FDA pathways, or early signals in Parkinson’s research, this chat is built for your watchlist. Subscribe, share the episode with a mate who tracks biotech's, and leave us a review so more people can find the show.

Transcript

Andrew Musgrave

Welcome again to ASX Briefs. And today we're joined by Gary Phillips, the CEO of Syntara Limited, a clinical stage drug development company specializing in extracellular matrix dysfunction with world-leading expertise in amine oxidase chemistry. The company is advancing multiple candidates in targeting blood cancers, fibrosis, and neuroinflammation. Gary, great to have you with me today and welcome to the ASX Briefs Podcast.

Gary Phillips

Thanks, Andrew. Looking forward to it.

Andrew Musgrave

Now, Gary, for investors that may be unfamiliar with Syntara, can you just provide a brief overview of the company?

Gary Phillips

Yeah, so we're a clinical stage biotech company. I think if you're thinking about putting in Syntara on your watch list or thinking about biotech in general, there's a couple of things that make us stand out or different. First of all, we've got some smart money backing us. So, we're over 40% institutionally held, which is unusual in that sort of small, medium-sized market cap bracket for biotech. And a lot of that money is from healthcare specialist investors. And even more than that, several of those investors have actually made money in investing in companies and exiting who've got had a lead asset in the same disease that we're studying. So, there's some insider kind of knowledge in the in the investor base there. Secondly, we're not a virtual biotech. We actually have our own labs and our own drug discovery group, which again is different from a lot of biotech’s on the ASX. That's allowed us to build a pipeline of drugs, which you're going to see if we talk about the pipeline later, multiple shots on goal from drugs which are fully owned by Syntara shareholders and with long patent lives as well. And then last but not least, I think you know, we've the amount of news flow that's coming. We have it in biotech land phase two studies where you see efficacy and safety for the first time in clinical trials, is really where rubber hits the road and market values take off. And we've got five trials due to report in before the end of this year. So, it's a good time to be looking at Syntara.

Andrew Musgrave

And Gary post quarter end, Syntara received positive feedback from the FDA following a Type C meeting on Amsulostat. So, what did the feedback tell you about your development pathway?

Gary Phillips

So yeah, I mean the FDA are our, I guess, our main guide for moving products forward in the in the pharmaceutical world and getting approvals. So, getting their endorsement to your clinical development plan is a vital step in the development. Our lead asset, Amsulostat, is already shown it works in a disease called myelofibrosis, which is a cancer of the bone marrow where the bone marrow becomes fibrotic and it stops producing red cells and white cells and platelets. Patients have about a five-year life expectancy. And we took that data to the FDA of the study that we'd run and the and the patients we looked at, they investigated all of the safety data we had, all of the preclinical work we had, all the clinical data. And they approved a phase 2B study to go forward. So that's a study where we're comparing our drug with a placebo when we add it on to the current standard of care in that disease area. Earlier studies showed that patients given that had a, first of all, a remarkable safety profile. We didn't see any serious adverse events in any of the patients that we've trial the drug on. That makes it stand out really from other drugs that are in development. Secondly, in terms of efficacy, we saw about three-quarters of the patients had a symptom score improvement, which is the primary endpoint the FDA looked for, more than halve their symptom score. And again, that was an outstanding development versus other drugs in the pipeline. So FDA endorsing that, saying it's okay to go forward with that study now, looking at two different JAK inhibitors, the standard of care with our drug added on top, not only gives security for the company in terms of making sure that what we're doing has that level of regulatory endorsement, but also it's the kind of endorsement that opens up potential partnering opportunities with large pharma companies who also have drugs in hematology or oncology disease areas and are actively looking at the moment. So that that endorsement from the FDA was a real step up for the company in terms of its validation of its technology and a clear pathway forward.

Andrew Musgrave

And aside from myelofibrosis, you're trailing Amsulostat in myelodysplastic syndrome. Can you tell us about the status of that trial?

Gary Phillips

Yeah, myelodysplastic syndrome is a related blood cancer. Also, the involves the bone marrow. These patients probably there's a greater unmet need here even in in myelofibrosis. So, there's more patients. The market is considerably bigger. There are more patients with my myelodysplastic syndrome, or MDS as we often abbreviate it to. The drugs which are currently used there are pretty toxic. They're very poor tolerability, so they do help patients a bit, but relatively short periods of time because the patients don't tend to stay on them very long. So, a real high unmet need. So our drug was first picked up by a German university who put it into some preclinical work in a model that showed that when you add our drug on top of current standard of care, you saw a rapid improvement in red blood cells, which is one of the key aspects of the disease you'd like to improve. And that German group then expanded that and they got a grant from the German Cancer Fund to do a large study in that. And that study is now recruiting, it's underway, and we expect to see preliminary data by the end of the year. Having got that one underway, we also then had attracted a grant from the Australian government, the MRF grant, for doing a study in a different segment of MDS patients, so in the patients that were a bit milder than the ones the Germans were studying and that study has got now got, I think, six centres open in Australia and it's about to start recruiting. So, we're also hopeful of seeing some preliminary data about that around the end of the year as well. So MDS is an important indication extension for our lead asset. And if it we get through these next stages and we're looking at potential partnering, it doubles the value of the asset because any pharma company looking at this saying, oh, we can no longer we can now develop it not only for myelofibrosis but also in MDS and that you know the double the revenue, more than doubles the revenue. So, it's an important bit of data that we're expecting later in the year.

Andrew Musgrave

Also, in the quarter, you completed recruitment in the phase two trial of SNT-4728 for isolated REM sleep behavior disorder. So why is IRBD such an important target and what will the pending trial results tell us?

Gary Phillips

Yeah, so this is a bit of a flip from were wanted to confuse your listeners about the those various technologies, but whereas our drug in myelofibrosis and MDS is an antifibrotic dealing with sort of fibrosis in the bone marrow, the drug 4728 is one of the first drugs we developed from our unit, and it's an anti-inflammatory and it works in the brain, so it crosses the blood-brain barrier, and in all the preclinical work we've done reduces inflammation in the brain. Now, there's a maybe not a well-known fact that you know, Parkinson's is a very prevalent disease, everybody's heard of it, and they practically everybody has got somebody that they know in their family or a friend that's affected by the disease so awareness really high. But many of these patients start out with a sleep disorder called IRBD, which is isolated REM sleep behaviour disorder. So, this is a disorder where patients actually act out their dreams. So, they actually get physical and they become very verbal, screaming and shouting as well. So, it's thought that of all these patients that develop this sleep disorder, of which there are many, most of them go on to develop Parkinson's within a kind of five, 10, 15-year period. So, it's one of those early states, it's prodromal to Parkinson's. So, if we could find a way of treating these patients early on, then maybe we could treat their sleep disorder, because at the moment they only take melatonin, there's not much else they can use. But maybe we could also prevent or slow the progression to Parkinson's as well. So that's what's attracted the clinicians in the area who've seen our drug. And it also attracted interest from philanthropic organizations. And Parkinson's UK, which is a philanthropic organization based around Parkinson's patients, funded this study to the tune of five million dollars. So, it's a three-month study, it's comparing our drug with a placebo. The patients take it for three months, and they have a brain scan at the beginning of the study and after three months, and we're looking for reductions in inflammation in areas of the brain which we know are in involved in both the sleep disorder and Parkinson's. So that study is actually fully recruited, so 40 patients. It recruited, fully recruited at the beginning of the year. The last patient has received their last dose, so we're now in the analysis phase, and we expect to deliver results from the primary endpoint of that study before the end of this quarter. So that's just around the corner. So that's a, if you think of all the news flow, we've got coming from Syntara, that's the first cab off the rank. We're really excited to see the result from it, as are the Parkinson's community as well. So yeah, that that was trial result coming up in a short while now.

Andrew Musgrave

Looking now at skin scarring, arguably the program that gets the most attention, you have two trials ongoing in skin scarring with initial results pending. Can you tell us about those results?

Gary Phillips

Yeah, the skin scarring, as you say, it attracts a lot of attention. I think it's because everybody's got a scar, right? And some of them are these scars that fade over time and don't cause a problem. But there are many, many, many people who end up with scars after surgery where the scar gets bigger over time, a so-called hypertrophic or a keloid scar. And in these patients, the scarring causes obviously cosmetic issues, but also functional issues as well, particularly if it's on a joint, an area like that where it reduces movement, particularly the hands, for example. If you see patients with burns and their scars on their hands, typically tend tighten over time and cause a restriction in movement. And that though those combination of cosmetic and functional changes also leads to mental health problems as well with these patients with scarring. So, we've had a drug which addresses scarring. We've worked very closely with Fiona Wood over in Perth for many years. Fiona's put it through her preclinical models and shown the drug had promise. And we've done a study with the drug in patients with scars that were 13 years on in old on average. And in those patients, we saw a 30% reduction in collagen content of the scars after three months treatment with our drug versus a placebo. So, we know that the drug does impact on the structural integrity of these scars. We're now doing a study again, placebo-controlled in patients with a sternotomy scar, a scar that goes down the middle of their chests. Those patients are receiving placebo and active, one part of their scar with placebo, one part with active. That's in the recruitment phase now. They're going to be treated for three months, and we think a result, again, by the end of the year, showing that you know we can really change the appearance of a scar with a three-month treatment with our topical drug. So, it's a cream that you rub on once a day. I can't tell you how big that that market is enormous. We all are aware of the amount of cosmetic and the surgery that's going on worldwide, on top of all the surgery that's done for them from injuries and accidents. There are no other clinical compounds in the in the clinic currently being developed specifically for these kinds of scars. So, this is a really novel way of treating them. A lot of endorsement from clinicians already got clinical proof of concept from an earlier study and a result that we're really looking forward to later in the year. Because I think it's a company maker all on its own, this drug.

Andrew Musgrave

And post-quarter end Syntara announced an $8 million institutional placement and a $2 million shared purchase plan. So, how does this funding position the company moving forward?

Gary Phillips

That that capital raise came a very important time for us with positive FDA feedback on the development pathway for our lead asset Amsulostat in myelofibrosis, giving us a clear late-stage clinical development path and you know, possibly triggering potential partner interest in the lead program. So, the capital that we raise is intended to support the continued development of that drug while simultaneously progressing the rest of the pipeline. I've explained as we've gone through this podcast that the pipeline is quite broad, but it's all come to a point where we're delivering results from the trial. So, this capital raise takes us through to quarter three, twenty-seven in terms of cash runway. And in that time period, you'll see all the results from those now five key clinical trial readouts and ongoing licensing discussions across the portfolio. Each one of those results is an opportunity for partnering as well. So, we believe there's a real opportunity for shareholder appreciation within the runway of that of this capital raise. And, you know, we hope that the SPP will be well supported by shareholders as well, getting us an additional level of security as we go forward.

Andrew Musgrave

And finally, Gary, you’ve described 2026 as a transformative year with five clinical data readouts expected. What's the story you want investors to understand?

Gary Phillips

I think the company is extremely well positioned. We've got FDA support on our lead program, multiple shots on goal across the pipeline, a very visible news flow throughout the rest of the year and put all that against what we would consider a modest valuation for the company. And I mean we're we've got a market cap of around 50 million. So relative to our peer group, I think we yeah, a modest valuation is the words I would use to describe that, Andrew. So, yeah, it's I think the company's certainly worthy of a second look for the those of you that are shareholders to thank you for your support. And for those of you who aren't, you know, put us on your watch list and see that we start delivering the results as we've talked about. Thank you.

Andrew Musgrave

Alright, Gary, well it's been great to chat today to get an update on where the company is at. Plenty of activity in the pipeline so we wish you all the best and we look forward to further updates from Syntara in the upcoming months.

Gary Phillips
 
 Thanks Andrew
 
 Andrew Musgrave

That concludes this episode of ASX Brees. Don't forget to subscribe, and we look forward to catching you on our next episode.