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

Good morning and welcome to the 2025 Annual General Meeting of Syntara Limited, which has been called by Notice of Meeting dated 20 October 2025. We have a quorum, and I now declare the meeting open. My name is Cameron Billingsley, the Company Secretary of Syntara. Today's meeting is being held as a virtual meeting via live webcast with the use of the Zoom platform and also the Lumi platform for voting. Shareholders and proxies have the ability to ask questions via Zoom and to submit their votes via the Lumi platform. You need to log into both platforms if you wish to both participate and vote. Firstly, I'd like to introduce our Board. Dr. Kathleen Metters, our Non-Executive Chair.

Hello. Good morning.

Gary Phillips, our CEO.

Good morning.

Dr. Simon Green, a Non-Executive Director.

Good morning.

And Mr. Hashan De Silva, a Non-Executive Director.

Good morning.

I'd also like to introduce our CFO, Tim Luscombe.

Good morning.

Mr. Zach Irvin, a representative of William Buck, the company's auditor, is also in attendance to answer any questions you may have on the financial statements. By way of agenda, waiting for the slides to catch up. By way of agenda, I note that Resolution 6 has been withdrawn. This is a special resolution and has been withdrawn due to insufficient support. We will take the notice of meeting and the proposed resolutions as read, and we will display the formal resolutions as the meeting progresses. As I mentioned before, questions can be submitted online at any time through the Zoom portal, and we will address them at the relevant times in the meeting, which will be after the CEO presentation and after proposing each formal item of business. Please also note that to facilitate an orderly meeting, questions may be moderated. And if we receive multiple questions on one topic, they might be amalgamated together. Voting is being conducted as a poll on all items using the Lumi platform. Enable to provide you enough time to vote, voting is now open for all resolutions. If you're eligible to vote at this meeting, a polling icon has or will shortly appear on the Lumi platform. Selecting this icon will bring up a list of resolutions and present you with the voting options. To cast your vote, simply select one of the options presented. You also have the ability to change your vote at any time until we close the meeting. I would now like to hand over to the Chair of the company and of this meeting, Dr. Kathleen Metters, to provide her address.

So thank you, and hello again, dear shareholders. So it's my pleasure to address you at this year's Annual General Meeting and to reflect on a year that has been marked by substantial clinical advancement for our programs, strengthened regulatory positioning for those programs and continued on executing financial discipline across the business. So Syntara as a company remains firmly focused on developing first and best-in-class therapies for patients who are living with serious diseases, primarily driven by fibrosis, inflammation and malignant bone marrow dysfunction. And the progress that we've made during the past year has really materially advanced that mission. Amsulostat has continued to demonstrate its potential to reshape the treatment landscape for myelofibrosis. The final 52-week data from our Phase IIa study showed a consistently strong and durable clinical response across a high-burden patient population. 73% of evaluable patients achieved at least a 50% improvement in symptom score and a 44% achieved meaningful spleen volume reductions of 25% or more. These improvements deepened over time with some patients maintaining these responses through the full year of treatment. Importantly, this was achieved with excellent tolerability and no treatment-related serious adverse events were reported over the 12-month duration. The strength and consistency of these outcomes firmly position amsulostat as a differentiated therapy with a multifaceted mechanism of action, targeting both fibrosis and aberrant growth factor signaling in the bone marrow. The U.S. FDA provided clear feedback on the recommended development pathway, and the company is now finalizing the design of our next clinical study to ensure that it fully captures both the magnitude and durability of the effects that have been seen to date. This week, very excitedly, we also welcomed a positive opinion from the European Medicines Agency to support our application for orphan drug designation for our agent and this really adds further validation from a major global regulator and paves the way for valuable commercial incentives in Europe once formal designation has been granted. To support the next phases of clinical and commercial development, we've appointed a group of internal -- sorry, international experts spanning both clinical practice and late-stage drug development in myelofibrosis. These advisers bring deep experience from companies and institutions that are responsible for the development and approval of leading JAK inhibitors and other hematology therapies. And they've already begun to contribute meaningful strategic and clinical guidance as we develop our next phase clinical plan. During the year, the clinical reach of amsulostat was also broadened into myelodysplastic syndromes, MDS. The AZALOX Phase Ib/II trial that has been initiated in Germany is now underway in high-risk MDS and CMML. And the second study in lower-risk MDS patients is being prepared in Australia. Together, these programs expand the opportunity for amsulostat into additional myeloid malignancies, where preclinical data have previously suggested that lysyl oxidase, the target of this agent, play a major role in clinical disease progression. Significant momentum has also been realized in our dermatological pipeline. Two clinical trials are currently in progress, the Phase Ia/b study of SNT-9465 in hypertrophic scarring and the satellite Phase Ic study of SNT-6302 in keloid scars. Both of these programs represent opportunities to bring the first pharmacological treatment options to patients that have scar-related conditions, a field so far dominated by interventions that are either painful, inconsistence and are best moderately effective. Early progress in recruitment and dosing reflects the professionalism of our clinical partners and the level of interest from patients in these novel antifibrotic approaches. Our broader pipeline continues to advance as well, most notably with SMT-4728 for isolated REM sleep behavioral disorder. This is a trial that is funded through our partnership with Parkinson's U.K. I'm pleased to report that recruitment is close to complete and interim data are expected in the first half of 2026. So as you can tell from these various programs, Syntara's portfolio now spans multiple clinical and preclinical programs that address fibrosis, inflammation and neurodegeneration. And this positions the company strongly with numerous meaningful clinical data readouts that are expected over the next year. Financially, the company remains in a sound position. We are well funded to continue advancing our clinical programs, supported by disciplined cost management and the continued benefit of nondilutive funding sources. This approach allows us to progress multiple studies in parallel while maintaining operational flexibility as we prepare for the next stages of the clinical development. So to conclude, I'd like to acknowledge the dedication of the team, the quality of our science and clinical collaborations and the trust and support of our shareholders. As a Board and the team, we are highly optimistic about the potential across all parts of the business, a compelling lead program supported by maturing clinical data, expansion into new blood cancer indications, 2 active dermatology trials and a sound financial position. And this will allow us to progress these programs with confidence. So finally, on behalf of the Board, I thank all shareholders for their continued support of our strategy and our vision, and we look forward to updating you as we strive to build value across the clinical portfolio in the upcoming year ahead. So thank you for your attention. And I'd like now to hand over to our CEO, Gary Phillips, who will give a short presentation.

Thank you, Kathleen. We can move to the summary slide, please. Thanks. There are several of these points that Kathleen has made in her address already. But I think the strength of the company at the moment is founded on a few key elements that we'll build on as we go into the year ahead. The first one being that Syntara is not a virtual company. It's a biotech company with its own drug development group in-house. We have labs here with scientists working and researching on the assets that now form the extensive pipeline that we are going to present to you shortly. The benefit of having that internal group is that we have full control over the intellectual property that we generate. All of our assets have a long patent life ahead of them, which is a key valuation point when dealing with potential partners and acquisitions of assets down the track. And it also means that we've been able to generate a pipeline where we have advanced it to the point where we have multiple shots on goal. So you'll see from the pipeline that I'll show at the end of this, the number of assets which are reaching clinical efficacy and safety data points in the next 12 months is extensive. The value of that pipeline and the number of shots on goal has been acknowledged also by the type of investors that we've attracted over the years. Syntara still stands out as being slightly exceptional in the small cap space in biotech in that we have a 43% institutional backing. Many of those are specialist health care investors. And many of them, in fact, have made money in exits from investments they made in companies in the lead indication of myelofibrosis, where our lead asset is currently generating Phase II data. So all of these things validate the business model of the company. It's generated a lot of opportunities for the future for shareholders. And through careful management of the cash, we also have a runway, which takes us through to the end of '26, beginning of '27, which will take us through many of those news milestones and valuation opportunities during the next year. Next slide, please. So this just summarizes really the history of the company from a share price perspective over the last year. I'll note on the left-hand side, the strength of the institutional ownership, which I talked about just now, but also the research coverage that the company has attracted. So again, for a small cap company, I think we find it unusual to see 4 different bits of independent research given. So if you want to know more about the company, there are plenty of independent sources where to go. At this particular moment in time, we had at the end of September, we had $14.4 million in the bank. As I said, that takes us probably through to the end of the year, beginning of 2027. And the market cap of around about $50 million, I think with the news flow and the asset milestones coming up represents very good value at the particular moment in time. Next slide. The lead asset is in a disease called myelofibrosis. It's an orphan disease. Patients typically get this from the age of 50. Many of them transform into leukemia. It's a fibrosis of the bone marrow, which eventually leads to symptoms such as enlargement of the spleen, night sweats, bone pain, fatigue. These patients have about a 5-year life expectancy from when they're sick enough to be diagnosed and treated with the first available treatment, a JAK inhibitor. But at the moment, there are no treatments available which modify the course of this disease. Next slide, please. Current standard of care are drugs called JAK inhibitors. These drugs are quite good at reducing the size of the spleen. So patients with myelofibrosis often have a spleen size of could be 3 liters or more, so 10x what the normal healthy person would have. And the JAK inhibitors do reduce the size of the spleen in some patients. They also improve symptom scores in some patients, but they don't change the course of the disease. And despite being only symptomatic in treating the disease, their sales in the order of $2 billion a year. So this is an area which is of high commercial interest. There's a very high unmet need for drugs that will work alongside a JAK inhibitor on top of them to help improve the lives of these patients and help them live longer lives and healthier lives. Next slide, please. Our lead drug is an inhibitor of an enzyme called lysyl oxidase. Lysyl oxidase is an enzyme which causes cross-links in collagen and causes the fibrotic tissue, which fills the bone marrow and is the root cause of the disease myelofibrosis. Our drug given twice a day almost completely inhibits that enzyme. And in doing so, is hoped to relieve the course of the disease in terms of its symptoms, but also change the course of the disease in changing the nature of the bone marrow in these patients. We've conducted a number of studies under an IND from the FDA. We've already reported a monotherapy study where we reduced the amount of fibrosis in the bone marrow as measured by bone marrow biopsies in patients taken at baseline and at 6 months, but also improve symptoms, spleen size and blood staying pretty stable at the same time. Based on that early positive result, we went back and have now trialed the drug on top of the standard of care JAK inhibitor, ruxolitinib, and then a study that lasted for 12 months. So the study results I'm going to show you are things that we reported interim data at the American Society of Hematology in 2024 and which the final results were published only a month ago and which will be presented at the American Society of Hematology at the beginning of December in just under a month's time. Next slide, please. These patients that were in this study had severe fibrosis of their bone marrow. They had been on ruxolitinib, the leading JAK inhibitor for on average for 3 years. So these were patients well down the track of myelofibrosis. They probably didn't have that much longer in their disease to go before failing on the JAK inhibitor. Many of them had enlarged spleens and many of them had increased symptom scores. The average symptom score of patients in this study was 23, and that is considered to be severely symptomatic in this patient group. Next slide, please. The 2 key endpoints from the study on top of the safety profile, which, again, on top of the previous study showed a drug which was very well tolerated and had no serious adverse events in patients we're taking it now to 12 months, which is very reassuring. We looked, first of all, at symptom score. In this case, regulators globally look at a reduction in symptom score of 50% as being the mark of a responder. So if you reduce the symptom score by 20% or 30%, you are not determined to be a responder. So it's a pretty high bar. It's a patient-reported outcome. But nevertheless, the level of reduction you need it is extremely significant. So we were delighted to see that almost 3/4 of the patients at week 24 or 6 months or beyond in this 12-month study had a reduction of more than 50% in their symptom score. And again, encouragingly, we saw that response to the symptom score reduction increasing over time. This is quite unusual. Other drugs which have been trialed in this disease on top of JAK inhibitors in similar kinds of studies have shown improvements in TSS50 for around the 30% to 40%. So to see 3/4 of patients improve at this level is quite a dramatic finding. So from a profiling point of view, we believe that we have a best-in-class drug from a safety perspective and also a best-in-class drug, albeit with a small amount of data at this point in terms of reducing symptoms. Next slide, please. The other element for managing myelofibrosis at this stage is showing a reduction in spleen size. And here, the note of a responder is a 25% reduction in spleen size in these patients who are already taking JAK inhibitor ruxolitinib in this case. And again, we saw almost half of the patients at 6 months and beyond have a reduction in spleen size that was more than 25%. So a very encouraging response and matches well with other drugs, which have been used on top of ruxolitinib. So best-in-class safety, best-in-class symptom score and a very competitive reduction in spleen volume reduction. Next slide, please. So having presented these results to the market and then for our peer group at the American Society of Hematology in a couple of weeks' time, we are engaged now with the FDA. We're discussing with them the next stage in clinical development. They've given us advice on the study, the type of study that we should run and the endpoints that we should have. We're now putting together a protocol, which we will put back to the FDA towards the end of the year. Next slide, please. To help us do that, we put together an advisory board of global opinion leaders. On the clinical side, Professor Claire Harrison, Dr. Gabby Hobbs, Professor John Mascarenhas, are all well-known experts in myelofibrosis and also well known to the regulators as well. And they're working with us on the protocol that would enable us to demonstrate clearly the efficacy and safety of our drug on top of JAK inhibitor when given to patients who are not well controlled on a JAK inhibitor. They've been joined by 2 industry experts as well, Dr. Adam Craig and Dr. Kevin Lynch. Dr. Adam Craig was the CEO of CTI BioPharma, who themselves developed a JAK inhibitor right the way through Phase III and to commercialization and then exited with a sale to a company called Sobi. Next slide, please. And this really just underpins the commercial value of the asset we have. These are the last deals that have been done in myelofibrosis over the last few years. You'll see there, second from the right, CTI and the sell to Sobi for $1.7 billion. So we have the CEO of that company now as an adviser to the management team and the Board. In fact, we had a call with him earlier this morning to discuss the feedback we've been getting and the proposals we have for developing the future and the partnering engagement that we're currently having with potential acquirers of the asset. You can see from all of these deals that the level of commercial interest drives very high asset values for drugs which have finished Phase III, which are the 3 assets over on the right-hand side here. And perhaps one that's more relevant is a fairly recent acquisition by Takeda of Keros, who had a drug in myelodysplastic syndrome and myelofibrosis. It's important because our lead asset, amsulostat is going ahead in myelofibrosis, but also has 2 trials underway in myelodysplastic syndrome. That had reached Phase II and sold for an upfront of USD 200 million with milestones and total deal value of $1.1 billion. So whichever way you look at this, the myelofibrosis and hematology/oncology in general remains an extremely useful and valuable disease area. And that's been matched up by the level of interest that we are seeing incoming now that we've published the final results from the Phase IIa study in myelofibrosis and the number of companies that we are engaged with at the moment in discussions about our plans for the future. Next slide, please. So let's just talk about the pipeline and the news flow for a moment. Next slide [indiscernible]. So our lead asset, amsulostat, has finished Phase II. The next news flow we expect from that is an approval from the FDA of our development plan and further engagement with potential partners in the first half of '26. So the next step for that drug is either to go on to a Phase IIb study funded by the company or an acquisition at that point by a partner or something in the middle, a collaboration where we have some strategic involvement in the next study that we run. That is likely to happen in the first half of next year. That same drug is in 2 myelodysplastic syndrome studies. This is a related indication. And both of those studies are Phase Ic, Phase II studies. So the Phase Ic studies are -- the one in Germany in high-risk MDS has already been initiated and its recruiting. The one in low-risk MDS, which is being run in Australia is about to initiate. Both of those studies should give us interim data by the middle of next year and will add considerably to the value of the asset, particularly in terms of a partnering or collaboration deal. So really exciting times for that drug. It's produced an awful lot of data in the last year and a lot more data to come in the next financial year even. So I want to really keep our eye on -- that same technology of pan-LOX inhibition. We've applied to skin scarring and that drug formulated as a cream and is going ahead now in 2 different studies, one in hypertrophic scarring, where we will have an update later on in this quarter on the results from the Phase I safety PK/PD study, looking at the safety of our drug, SNT-9465 and then more further details on the clinical program ahead in hypertrophic scarring. So I'm really looking forward to explaining more about that in the weeks to come. And then secondly, in keloid scarring where we continue our collaboration with Fiona Wood and the UWA in Australia, where they're looking at a study in keloid scarring, again, a Phase Ic study, but with patients with keloid scarring that's recruiting well at the moment. And again, we expect data from that in the first half of next year. So -- the skin scarring program, we believe, has enormous commercial value. It will be very attractive for potential partners and investors alike. And we do expect to see data coming from that in the next -- within this financial year and into the next one as well by the end of the next calendar year. So I think a really exciting program that many of us believe has a great future ahead of it. And last but not least is the program in Parkinson's disease. Again, I'd remind you, this is fully funded by Parkinson's U.K. This is a free shot for the company. This drug trial is recruiting extremely well. We expect recruitment to finish by the end of the year. It's a 3-month study, and we expect, therefore, to have results from this Phase II placebo-controlled study in the second quarter of next year, calendar year. So I think you'll agree if we refer back to that slide on the share price and the market cap, a market cap of under GBP 50 million with this level of Phase II, Phase Ic assets delivering data within the cash runway of the company is an extremely strong position to be in at this particular point in time, and we certainly look forward to the year ahead. With that, I'll finish my address and I'm happy to manage some questions now.

[indiscernible] I just have one question in the queue so far. There was anticipated news flow during H2 2025 that seems to have changed. Could you please give shareholders some updates, please?

I'm not sure what that would be. I think we -- the studies that have been running in myelodysplastic syndrome, the one in Australia that's managed by the Australian lymphoma and Leukemia Group has been slower to start. They've had some drug supply problems. There's 2 different drugs going into that study. It's an independent study. It's not being run by Syntara. It's being run by the ALG under a grant from the Australian Medical Futures Fund. So we've seen some delays in that, which pushed out. But we still believe from a -- whilst the starting of that study has probably slipped from what we predicted to be quarter 3 to quarter 4, we still expect to see some data around the middle of next year. So the outcome of that study, we don't believe has changed that much. The skin scarring program has remained on track in terms of delivering results from the Phase I study. And I'm delighted actually at the progress. And we will give a further announcement on the clinical development path for that, but we believe we've managed to actually accelerate that program because of the good results that we've seen to date. So we'll have a further update on that when we finalize it, as I said, before the end of the year.

I'm showing no further questions at this stage.

So we'll now close questions. But if we haven't answered a question, then we will try to answer them via e-mail at a later date. So we will now proceed with the formal items of business. The first order of business is to receive and consider the financial report, the directors' report and the auditor's report of the company for the year ending the 30th of June 2025. These reports are contained in the statutory annual report of the company, which I tabled before the meeting. Are there any questions?

No questions at this stage.

As this matter does not require a vote, I declare that the financial report, the directors' report, the directors' declarations and auditor's report for the financial year ending the 30th of June 2025 have been received and adopted by the meeting. So I now move on to the resolutions. Resolution 1 is an ordinary resolution that relates to the adoption of the remuneration report. The vote is an advisory vote and voting exclusions apply. The proxy votes received prior to the meeting are displayed. Are there any questions? [Voting]

Are there's any questions.

There's no questions.

So as noted earlier, voting for this resolution and all other resolutions will be conducted as a poll, which remains open until the end of the formal items of business. So Resolution 2, Resolution 2 is an ordinary resolution that relates to the reelection of Mr. Hashan De Silva as a Non-Executive Director of the company. And so before proceeding with the resolution, I would like to ask Hashan to say a few words about itself.

Thank you, madam chair, good morning shareholders. As you know, my name is Hashan De Silva. I'm currently the managing partner and founder of a health care investment firm called KP Rx, which is domiciled in Sydney, focused on biotech, medtech companies that are based in Australia and New Zealand. Prior to this, I had a couple of roles in investment banks as a health care analyst. And before entering the finance industry, I worked at Eli Lilly. I hold a specialist degree in medicine, master's degree in finance and I'm a CFA charter holder. I am privileged to be part of this journey and look forward to the year to come at Syntara. [Voting]

So thank you, Hashan. The proxy votes received prior to the meeting is set out online. Are there any questions?

There are no questions.

Thank you. So moving on to Resolution 3. And again, thank you, Hashan. Resolution 3 is an ordinary resolution that relates to the annual grant of performance rights to Gary Phillips, our CEO. Voting exclusions apply in respect to Resolution 3. The proxy votes received prior to the meeting are set out online. And again, are there any questions?

No questions.

Thank you. Resolution 4. Resolution 4 is an ordinary resolution that relates to the approval of the grant of performance rights to Mr. Gary Phillips in lieu of cash salary and superannuation. And again, the proxy votes received prior to the meeting are set out online. Does anyone have any questions?

No questions.

Thank you. I'm now going to ask Gary to take the chair for the Resolution 5.

So Resolution 5 is an ordinary resolution that relates to the approval of the grant of nonexecutive director options to Dr. Kathleen Metters. Proxy votes received prior to the meeting are set out online. Does anyone have any questions for this resolution?

No questions.

I'll now hand the chair back to Kathleen.

Thank you, Gary. So that concludes our discussion on the items of business. I am about to close the voting system -- sorry, Resolution 6. As previously noted at the beginning of the meeting, Resolution 6 has been withdrawn. I wanted to make sure that, that was included. That concludes our discussion on the items of business. I'm about to close the voting system. Please ensure that you have cast all your votes on all resolutions. I will pause briefly to allow you time to finalize these votes. Voting is now closed, and the results of these votes will be released to the stock exchange later today. As there is no further business, I declare the meeting closed, and thank you all for attending.