Syntara Limited (ASX:SNT)
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May 7, 2026, 4:10 PM AEST
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AGM 2024

Nov 27, 2024

David McGarvey
Company Secretary, Syntara Limited

Welcome to the 2024 Annual General Meeting of Syntara Limited, which has been called by notice of meeting dated 25 October 2024. We have a quorum, and I now declare the meeting open. My name is David McGarvey, 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 Meeting platform for voting. Shareholders and proxies have the ability to ask questions via Zoom and submit votes via the Lumi Meeting platform. You need to be logged onto both platforms if you wish to participate and to vote. First, let me introduce our board. Dr. Kathleen Metters, Non-Executive Chair.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Hello.

David McGarvey
Company Secretary, Syntara Limited

Mr. Gary Phillips, our Chief Executive Officer.

Gary Phillips
CEO, Syntara Limited

Good morning.

David McGarvey
Company Secretary, Syntara Limited

Dr. Simon Green, Non-Executive Director.

Simon Green
Non-Executive Director, Syntara Limited

Hello.

David McGarvey
Company Secretary, Syntara Limited

Mr. Hashan De Silva, Non-Executive Director.

Hashan De Silva
Non-Executive Director, Syntara Limited

Good morning.

David McGarvey
Company Secretary, Syntara Limited

I would also like to take this opportunity to introduce our CFO, Mr. Tim Luscombe.

Tim Luscombe
CFO, Syntara Limited

Good morning.

David McGarvey
Company Secretary, Syntara Limited

Representatives of PwC, the Company's current auditor, are also in attendance. We would take the notice of meeting and the proposed resolutions as read, but we'll also display them as the meeting progresses. 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 item of business. Please also note that to facilitate an orderly meeting, questions will be moderated, and if we receive multiple questions on one topic, amalgamated together. Voting is being conducted as a poll on all items using the separate Lumi Meeting platform. In order to provide you with enough time to vote, voting is now open for voting on all resolutions.

If you are eligible to vote at this meeting, a polling icon has or will shortly appear on the Lumi Meeting platform. Select this icon. We'll bring up a list of resolutions and present you with voting options. To cast your vote, simply select one of the options. You have the ability to change your vote up until the time we declare voting closed, which will be at the end of 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.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Thank you, David, and welcome, everybody, and thank you for joining us today. So, as David said, my name is Kathleen Metters, and it is my pleasure to address you as Chair of Syntara. And this marks just over a year since I stepped into this role. And reflecting on this past year, I'm really proud of what we have achieved and really energized by the path that we have forged forward and that you will be hearing about today in the CEO's address. So, the journey to redefine Syntara began just over 12 months ago when we announced our transformation from Pharmaxis to a streamlined company, Syntara, a company still dedicated to advancing high-potential assets that address pressing and unmet medical needs in healthcare. And this was really a radical shift, and it was essential for the well-being of the company.

We recognized the need to focus fully on our pipeline, people, and scientific advancements that really have high impact. So, in practical terms, this meant taking a close, strategic look at our operating model, and we made tough but necessary decisions to align our structure with our ambitions. And so, we streamlined our team from 65 - 25 exceptionally skilled individuals and in total reduced our expenses by approximately AUD 14 million annually. This obviously marked a significant cost adjustment that aligns with our leaner, purpose-driven mission. So, this was a bold move, but it allows us to focus all our resources on progressing our most promising drug candidates and navigating their path towards commercialization. Even with this transformation, we've remained steadfast in advancing the critical development steps for our lead asset.

This is SNT-5505, and this compound sits at the heart of our pipeline and embodies the promise of our work. Our phase II trial in myelofibrosis has achieved full recruitment, and this is a major milestone that strengthens the foundation of our ongoing hematology program. Additionally, we are pleased to report that we successfully attracted non-dilutive funding for two new studies focused on myelodysplastic syndrome, or MDS for short, which is slated to begin next year. This funding is a significant achievement that highlights the externally recognized value and potential of SNT-5505, and it ensures that we continue to invest in our science while respecting our shareholders' interests. Looking ahead, we approach the next 12 months with continued focus and excitement. We're slated to present interim data from our myelofibrosis study at the American Society of Hematology, ASH.

This meeting is in a matter of days now, and this is a milestone that we have been working towards for the whole year. Off the back of the data from this study that continues to accumulate, this study is currently ongoing. We expect to engage the FDA as we redefine and define our pivotal trial design, and this will be crucial to guiding the future of the compound SNT-5505 beyond this point. Beyond this, the two MDS studies will continue to expand our clinical reach and help position SNT-5505 as a potentially transformative therapy for patients facing this challenging hematological condition. On a more personal note, my time in the pharma field has taught me the immeasurable value of a strong and well-supported pipeline. I believe deeply in the potential of SNT-5505, and I'm really encouraged by the wealth of new opportunities being developed within Syntara's broader portfolio.

These are also assets that have the potential to develop real value to both patients and our shareholders to create lasting benefits and impactful therapies that align with our core mission. Before closing, I would like to extend my heartfelt gratitude to our CEO, Gary Phillips, whose steady leadership has been instrumental throughout this transformational period. I'm also deeply grateful to our dedicated management team and my fellow board members, each of whom has played a critical role in steering us through this transition and towards a promising future. Together, we are building a company that I am proud to chair, and I look forward to the progress that we make in the coming year. Thank you for your continued support of and commitment to Syntara. Thank you. Our CEO, Gary Phillips, will now give a short presentation. Gary.

Gary Phillips
CEO, Syntara Limited

Thanks, Kathleen. David, can you go to the next slide and the next one. So, welcome all of you this morning. Thank you for taking the time to join us. I'll do a relatively short presentation which really covers off some of the key issues that the Company has both been working on in the last year and looking ahead to the year ahead, and in particular, I guess, addressing some of the concerns and opportunities that lie in investing in biotech and smaller companies like ours and why Syntara stands out as an investment opportunity at this particular moment in time. First of all, Syntara is a clinical stage drug developer. Now, many of you who are investors in healthcare stocks will know that really the time when value appreciation is at its highest is when we first get to test our drugs in patients.

So, there's a lot of work that goes on to get to this point in preclinical work and then safety studies in healthy volunteers. But the moment when we try our drugs for the first time in patients to see whether they're safe and obviously whether they work is the point when valuations can really change quite dramatically. Syntara is a company with not just one asset at that particular point in time in phase II, but three different drugs, and over the course of the next year, five different studies, all of whom will produce data starting in December this year in a couple of weeks' time and going right the way through to the end of 2025. So, probably because of that, Syntara has a large following from specialist healthcare institutions. Our register is more than 52% institutional.

Many of those investors are specialist healthcare investors who've done a lot of diligence and talked to many expert opinion leaders in the fields that we work in before deciding to invest in the Company. And I think that's a validation both of the Company, of the science that we've developed, and of the design of the clinical studies that we're going forward with. And just to talk just briefly about that pipeline and those number of drugs, that comes because the other thing which stands out as a differentiator of Syntara versus its peer group is that we have our own in-house drug discovery group, a group that have produced several compounds that have got through preclinical and into the clinic. The advantage of that is that these are not assets which are licensed in externally. We don't owe royalties to anybody else.

Syntara shareholders own 100% of all of those drugs that we're moving forward with, and because we've efficiently managed them, they also have a very long patent life. For example, our lead asset, SNT-5505, despite already being in phase II studies, has a patent life that stretches out beyond 2040, a really long time and something which adds considerably to the value of the drug when we get into discussions with potential partners further down the track who are interested, obviously, in how much patent life is left by the time you get into the bigger phase III studies. Next slide, David. I'll just go into that register a little bit more. Our current register, the largest investor is D&A. They're a U.K.-based fund. They've been with us for more than 10 years.

They increased their ownership of the Company in a raise that we did in December 2023 from 12%. Again, did a lot of diligence before they did that. Platinum Investment Management, many of you will be familiar with, is a specialist healthcare investor. Also increased from 8% in that raise in December last year on the back of doing further diligence in the Company and being comfortable with the clinical trial design and the outcomes and disease areas that we were working in. And then last but not least, BVF Partners, a very large U.S. West Coast-based specialist fund, which, like Platinum, have invested in companies which have exited drugs and made a lot of money for their shareholders in myelofibrosis, the lead asset indication which our asset is being moved forward at the moment.

I think I would determine some of these people as institutional insiders and that they really understand the commercial space that we operate in, the disease areas that we're trying to work on, and what looks like success in this area. As at the end of September, the Company had AUD 10.4 million in the bank. Our burn rate, net of the R&D tax credit that we get from the Australian government, is around about AUD 1 million per month. That 10.4 million gives us cash out to the middle of 2025. As you can see from the share price chart on the right-hand side, the stock has gained some momentum in the last six months, and that's probably due to anticipating the first trial results which are due to come out at the American Society of Hematology in December. A bit more about that later. Next slide, David.

Our science is based around small molecule drugs. Syntara is not a company that works in cell therapies or biologics. Our drugs are small molecules that are inhibitors of an enzyme called lysyl oxidase. If I could use an analogy of any of you who have scars on your skin, you'll be very well aware that when you cut your skin, the area becomes inflamed, swollen, painful. It then goes through a period of wound healing where the wound closes, and then the scarring process takes over. Now, that scarring process is caused by cells in your skin called fibroblasts which become activated by the injury. They release collagen fibers which are protein strands and an enzyme called lysyl oxidase. The enzyme lysyl oxidase causes those collagen protein fibers to become organized into layers and cross-link. That cross-linked tissue becomes stiff and hard.

You'll notice that in a scar on your skin. You'll see that the scar is often raised above the rest of your skin. It's of a different color. It's often paler than the skin around it, and it's much less pliable. It's not as flexible as the skin. It's not functional skin. It doesn't contain any hair follicles. It doesn't contain any sweat glands. The same thing happens in any of your other organs. If we look at your kidneys, your heart, your lung, your liver, injuries to any one of those organs, and that could come from a heart attack. It could come from liver disease that's caused by a diet that's very high in fat or alcohol.

Inflammation in those organs eventually leads to fibrosis, exactly the same process of lysyl oxidase and collagen distribution within those tissues causing scar tissue, and those organs then become non-functional. So, if you have lung fibrosis, your lungs become less elastic, less effective, and your ability to breathe reduces. So, we have a drug which fully inhibits lysyl oxidase. If you take two capsules a day, we inhibit it almost 100%, even at trough levels. So, we know that we have a very effective drug. We've already tried these pan-LOX inhibitors in two different indications. One of them is in myelofibrosis, where there's a fibrosis of the bone marrow, and secondly, in patients who had skin scarring where we applied a drug topically to them.

And in both those diseases, we showed that after, in the case of the skin, three months, and after the case of myelofibrosis, six months, we could measure a reduction in the fibrosis. So, the studies that we're now engaged with are trying to demonstrate that a reduction in fibrosis leads to clinical benefit. So, as an example, if you had lung fibrosis and you went to your doctor, you probably wouldn't go in and complain that you had too much fibrosis in your lungs. You'd go to the doctor and explain to him that you didn't feel you could breathe as well as you could do in the past. You couldn't do as much activity as you could do in the past.

It's very important for both patients, clinicians, and also regulators like the FDA, the TGA, that we have clinical trials that explain what's the clinical benefit of our drugs reducing fibrosis in these patients. Next slide, David. The lead, our lead asset, SNT-5505, we've chosen to go into a disease called myelofibrosis. Myelofibrosis is a fibrosis or scarring of the bone marrow. Your bone marrow is your body's blood production unit, so it produces red cells, white cells, and platelets. So, as the bone marrow becomes fibrotic, it doesn't do its job. You end up with cytopenia, which means low blood cell counts. The spleen becomes enlarged as it tries to take over production of some of those cells. Patients with this disease have a life expectancy of around about five years. It's an orphan disease, and these patients suffer with a lot of symptoms.

Their spleens become often very enlarged. A normal person's spleen would be in the realm of 300 mL. Patients with myelofibrosis can have spleens in excess of 3 liters. They also suffer from night sweats, bone pain. They're easier to bruise. They get more infections. The only drugs that can treat this disease at the moment are drugs called JAK inhibitors. There's four of them on the market. One of them has been there a long time and has by far the biggest market share, a drug called ruxolitinib. These drugs are pretty good at controlling symptoms and, in particular, reducing the size of patients' spleens. However, they don't do anything about the underlying cause of the disease, the fibrosis in the bone marrow, and therefore these patients don't live longer. These drugs and most of the drugs in development also are very poorly tolerated.

JAK inhibitors, by reducing the size of the spleen, also dampen down cell production and therefore cause more cytopenia. The very problem that we're trying to solve for in myelofibrosis, these low blood cell counts, JAK inhibitors often make worse. The way that clinicians respond to that is by reducing the dose of those JAK inhibitors, and eventually patients have to come off of them because they can no longer tolerate them. Once a patient comes off of a JAK inhibitor, they have around about 12 months to live. There is a huge unmet need for drugs which will work alongside a JAK inhibitor, not only controlling the symptoms but also giving some hope that will change the course of the disease, change the course of myelofibrosis, and give some hope to these patients. That's where our drug comes in. Next slide, please, David.

We went to the FDA back in 2020. They gave us an IND. They reviewed all of our safety, toxicity data, our preclinical data, and gave us permission for us to go into a study in healthy volunteers to see what the drug would do. They gave us orphan drug designation. Following a successful phase I study in healthy volunteers, we then went into a study with patients who had failed on a JAK inhibitor. These were patients who were end of life, probably one year or less to live, and we trialed them for six months on our drug. That data we presented at the American Society of Hematology in 2023. I keep mentioning the American Society of Hematology. That's because it's the world's largest hematology conference. Some 35,000 people attend it each year.

It's the showcase where all companies and all researchers take their research to show and explain to the scientific community what's going on. The response from the scientific and clinical community to our first study in the monotherapy was a positive one. The major positive reaction came around the drug safety profile, that this, unlike its peer group and other drugs in development and ones on the market, SNT-5505 is remarkably well tolerated. We had no serious drug adverse events that led to any patient withdrawals in the study. Most of the adverse events were mild, and this really stands out. If you're going to have a drug which is going to eventually add on to a drug which does have a poor tolerability, this makes it much more likely that it's going to be used and taken up by clinicians and patients.

On top of that, we showed that many patients had a reduction in that bone marrow fibrosis that we talked about earlier. So, we showed it was anti-fibrotic. But we also showed many patients that had improved symptom scores, stable or improved blood counts. And overall, I would describe the result as being a really endorsement of the drug as a safe drug and some encouraging clinical efficacy starting to emerge. We took that data back to the FDA in August of last year, 2023, and asked them for permission to go ahead in a study where we were going to add our drug on top of ruxolitinib, the market-leading JAK inhibitor. They approved that. We started that study in December of last year. Next slide, David. So, we started that study in December. It's 15 patients. It's open label.

We decided to treat these patients for 12 months rather than 6 months because we could see at the end of the last study that, rather unusually, our patients were still improving at that point. So, rather than just having an improvement and plateauing, we could see a picture emerging where patients continue to improve the longer they stay on our drug. So, we're choosing to follow these patients for 12 months. We're again looking at safety, but also looking at bone marrow fibrosis. We're looking at symptom score. We're looking at their spleen size, and we're looking at various hematological outcomes as well. So, all of these patients had to be on ruxolitinib coming into the study. They had to be on a stable dose for at least three months.

The first data from that study will be presented at the American Society of Hematology on December the 9th in San Diego. So, that will be December the 10th, Australian time. In that data reveal at that point, we will have approximately 10 patients' worth of data. All of those patients will have completed six months' worth of treatment, and half of them will have completed nine months' worth of therapy. So, we're expecting to be able to make a judgment, I guess, at this point about whether the drug is still safe in this patient population which is taking a JAK inhibitor. But also, we're hoping to see some clear signs that the drug is working in this patient population, particularly in those patients that have been on drug for nine months. That's a really important data point.

It's coming up very soon, and we're very excited and looking forward to both presenting that data at ASH and talking to the many clinicians that will be there listening to that presentation. We've been granted an oral presentation at ASH, so most of the research that goes to ASH gets put up as a printed poster that you get to put on the wall, and people walk past and can talk to you about it. Because of the level of interest in our drug and the mechanism, we were granted an oral presentation, which means we'll be presenting to a plenary session in a large room with people watching as we talk through the latest data that will be there. Next slide, David.

Among those people in the room will also be potential future partners, so other companies that are interested in this space who can see the commercial opportunity from a company and a drug which addresses the high unmet need in myelofibrosis. And this slide just covers three of the last companies that have had acquisitions after phase III data. So, we are currently at phase II. Our next study will be a phase II/III study, so a pivotal study to get approval. These are all assets that were sold after that pivotal study. The two on the right are JAK inhibitors sold for $1.7-$1.9 billion. Two institutions on our register were investors in CTI. So, obviously, BVF were actually, I think, the largest shareholder in CTI. The company on the left, MorphoSys, was sold to Novartis for $2.9 billion in February of this year.

It's not a JAK inhibitor. It's a potential competitor to 5505, our drug, and an eye-watering deal done after phase III. But three weeks ago, Novartis, who bought that drug, announced that they would not be seeking approval from the FDA this year, that there was an emerging safety signal from the data they had, and that drug is going to be delayed quite some time as they get to the bottom of what's actually gone on there. So, they've written $800 million off of their balance sheet, they reported three weeks ago, because of the problems with that drug. We believe that the field in myelofibrosis is actually opening up, that the need for a drug which both works on top of ruxolitinib in order to improve the life of these patients, but also is very well tolerated, has never been better.

We're very excited about the potential opportunity that lies ahead for 5505, and in particular, the interest that we may attract from some of these companies as we go forward. The next step in our development will be to see the further data coming from that study in March of next year that will have 12-month data in it that we think will fully characterize the drug and allow us to go back to the FDA and discuss with them in quarter two next year the design of the pivotal study that would take us through to registration. We would expect an outcome from that discussion with the FDA by the middle of 2025. Next slide, David. I mentioned at the outset the fact that Syntara is a more-than-one-shot on goal with several assets.

The lead asset, 5505, at the top there, obviously in that myelofibrosis study with data due in December, more data due in March, and then an outcome from the FDA around the middle of the year in June next year. Underneath that, we also have two studies which are due to start in the first half of next year. Both of them are funded by grant money, one of them from the Australian government and one of them from the German Cancer Fund in myelodysplastic syndrome. Myelodysplastic syndrome, or MDS, is another blood-related cancer. It's one where we've got very strong preclinical data that's been published in Nature, a very high-impact, peer-reviewed scientific journal. Those two studies are phase I/II studies, so a dose escalation study followed by dose expansion. We would expect data from the phase I/II, the dose escalation study, by the end of 2025.

That particular indication adds a huge amount of commercial value to the drug. As well as hopefully helping patients with MDS who are particularly poorly served at the moment, the unmet need there is maybe anything higher in myelofibrosis. The companies that are interested in myelofibrosis and assets there will be doubly interested if our drug also produces positive data in myelodysplastic syndrome. Secondly, we've taken the same mechanism, pan-LOX inhibition, and we have that in a set of trials that we're undergoing that we've been working with Professor Fiona Wood in the University of Western Australia in Perth in skin scarring. We have one ongoing study in scar prevention where patients with a burn injury that requires a skin graft are being given our drug after the skin graft has healed to see whether we can prevent a bad scar emerging.

Secondly, we're looking at hoping to start a pilot study at the beginning of next year in patients who have a keloid scar. So, these are scars which grow larger over time and largely affect people with more pigmented skin. Again, a pilot study. These two studies are indicative of a program which we think has huge commercial value for the future, which we will seek to expand our investment in as we see further results coming back from the blood cancer studies because we think the commercial opportunity in scarring is very, very large, and the competition in this space is very, very limited. So, there's a real opportunity here. Last but not least, a drug that was produced also in our pipeline that's an anti-inflammatory, SNT-4728. This is in a study of patients with a severe sleep disorder called iRBD.

These patients act out their dreams in a violent fashion. But perhaps more importantly, 90% of these patients go on to develop Parkinson's disease. We took the data from that drug and the stage it was at to philanthropic organizations a couple of years back, to the Michael J. Fox Foundation, to Parkinson's UK, to an Australian foundation called Shake It Up. These groups sit together once a year, and they review all of the science that's going on in Parkinson's disease and decide what they're going to fund. They try very hard not to overlap in their funding. Now, as a result of that assessment, Parkinson's UK chose to invest AUD 5 million into this particular trial. It's 25% recruited.

We've got study sites open in Sydney and in Oxford, and we expect that trial to be fully recruited by the middle of next year and produce data by the end of next year. The data from that will be in whether we improve sleep quality in these patients, but also whether we reduce inflammation in a particular area of the brain which is implicated in this progression to Parkinson's. So, three different drugs, five different trials that are ongoing by the middle of next year, all of which can produce news flow which we expect and hope will drive both interest and valuation in the Company. Thank you, David. We'll now respond to general questions.

David McGarvey
Company Secretary, Syntara Limited

You'll now respond to general questions which have been received either prior to the meeting or via the Zoom app. If shareholders and proxy holders wish to ask a written question, please use the Zoom platform and select the Q&A option on the center bottom toolbar, then type out your question in the text box provided and press submit. If you wish to ask a verbal question, click the raise hand button on the center bottom toolbar, and subject to available time will activate your microphone and camera. At this point in time, we do not have any questions that have come in on the Zoom platform, but we do have several questions that have come in on the Lumi Voting platform. I'll ask one of our team, Mr. Cameron Billingsley, to read those questions. Gary, I think there's four or five of them.

Gary Phillips
CEO, Syntara Limited

Okay.

Cameron Billingsley
Company Secretary, Syntara Limited

Good morning, everyone. The first question is from Mr. Stephen David Mayne. Item one, financials. Our market cap is currently AUD 66 million, and we have accumulated losses of AUD 400 million plus. Could the Chair or the CEO please provide a brief historical summary of who got the AUD 400 million and what decisions they would have made differently to produce a less disastrous outcome for shareholders?

Gary Phillips
CEO, Syntara Limited

Thanks, Cameron. Well, maybe I'll start the answer to that question because I think I'm in a good position to provide the history of the investments into the Company. And I might just turn to Kathleen just to give a broader perspective on drug development in biotech and pharma circle. So, first of all, I mean, the Company Syntara came from a Company that was known as Pharmaxis that was IPO'd back in 2003. That Company chose to license in a technology which we developed in two indications.

One was in asthma diagnosis, and the other one was in the treatment of cystic fibrosis. The money that we raised, much of that AUD 400 million that Stephen talked about in his question, was to take that drug through phase II and then three phase III studies in order to get it approved. The original commercial plan, clinical development plan for that asset was to have completed the phase III studies, get approval, and take it to market in 2012. Unfortunately, as happens in clinical research, sometimes your trials don't produce, I mean, the reason we do clinical research is to find out answers to questions, which is, does the drug work?

And there were a number of issues that were raised in the first two phase III clinical studies, which meant although we were successful in getting an approval for the drug in Australia and in Europe, when we took it to the FDA, they asked us to go away and do a third phase III clinical study. That phase III clinical study delayed the eventual approval of the drug, which did come much later on, about six years later. It cost a considerable amount of money to do those studies. We did finally get an approval. The drug has proven to be successful in cystic fibrosis in terms of treating patients. So, I would estimate there's probably something like 10% of patients worldwide that have taken or are taking bronchodilator treatment for cystic fibrosis.

So, we were successful in developing and creating a drug which does bring benefit to patients, which other drugs on the market don't do. But in the time delay that we had that was caused by that FDA reaction to our first data, a disruptive technology appeared onto the market, which meant that the commercial opportunity that we had was much, much smaller. The United States market for cystic fibrosis is a quantum leap higher than other markets in the world. So, the approvals in Europe and Australia were never going to make the drug a commercial success. It really relied on the U.S. And the delay in the U.S., which was extensive, was the reason why the drug didn't make it there and why, in Stephen's words, I guess, we had disastrous results for shareholders. And that is part of, unfortunately, investing in biotech is there is that risk.

Not all of our drugs work. Kathleen, maybe you could just comment on the sort of the average cost of developing a drug and the failure rate, just to sort of give a bit of context to what happened to us during that period.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Yes, absolutely, Gary, so as you're going to hear in a few minutes, I've spent most of my life in large pharma, but also in biotech, and I worked for 25 plus years at Merck, and while I was there, the translation rate from compounds that were good compounds and could be shown to be well tolerated and ready for advancement after initial trials in human volunteers, only about 5% or 10% of those compounds, when taken into the clinic, actually showed any kind of clinical efficacy.

An even smaller number showed the degree of clinical efficacy which would be needed to have a very high impact for patients and therefore would be worth taking through to further trials, which get increasingly expensive, and through to commercialization. The bar is very, very high, and the failure rate is very, very high. I don't wish to sound as though I'm offering sort of excuses. I'm really offering reasons. What I would say is that those failure rates that were seen at Merck during my time were also those that were experienced across large pharma in general and also in small companies. It cannot be underestimated how high risk this business is and what a high bar there is to get over in order to have a successful compound that can then move on to commercialization.

So, what I would say is that we have tried to mitigate this risk by doing a couple of things, major things. One is we discussed in my address is to be really very, very focused on divesting the non-viable parts of the business and focusing on the viable parts of the business. In addition to that, we focused on an asset that is extremely well tolerated and extremely safe. Now, we don't know the degree to which this is going to be clinically effective enough to move into commercialization, but what we can say, it has the right kind of profile that will allow us to pursue clinical development in an extremely focused and as rapid as possible manner.

The final thing I would say is that, and this is just a comment on biotech in general, is we think of things, and this is a very broad bucket, but we think of things as being assets that we partner. And more often than not, that means that we give development decision-making to our partners. So, we are no longer really in control of the compound. And this has certainly been the case in Pharmaxis that partners decided not to continue development with compounds. So, that has been also a reason why some of the compounds have been stopped. Some of those, as you've heard from the iRBD study, we've been able to get back into the Company and reposition. So, those compounds are still under evaluation to see if they can provide benefit in other clinical settings.

But the other way we think about pipeline development is to develop what we call our proprietary pipeline. So, we develop it ourselves, and we have control over the development and the trial design for those compounds. And 5505 is a good example of that. This is the first compound, I believe, Gary, that we have taken into clinical development since the CF franchise. And so, we are really very, very enthusiastic about the fact that we have enough finance to develop this compound ourselves at this moment without the necessity to partner at this point in time.

Gary Phillips
CEO, Syntara Limited

Thanks, Kathleen. Cameron, any other questions?

Cameron Billingsley
Company Secretary, Syntara Limited

Yeah, there's a few others. So, from the same shareholder, Mr. Mayne, given the interesting discussions across a range of topics today, could the Chair undertake to make an archived copy of the webcast, plus a full transcript of proceedings available on the Company's website? There is no full webcast available online from last year's AGM, just copies of the formal addresses. Judges aren't told to go back and watch video webcasts, and politicians have Hansard, which provides a full written record of proceedings. The likes of Nine, AGL, ASX, ANZ, Domino's, IAG, Lendlease, and Woolworths are all routinely produce transcripts. Will you follow suit today in addition to publishing a full archive of the webcast?

David McGarvey
Company Secretary, Syntara Limited

I think that's possible, Gary. We can do that.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Yeah.

Cameron Billingsley
Company Secretary, Syntara Limited

Yeah.

Gary Phillips
CEO, Syntara Limited

Yeah.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Yeah.

Gary Phillips
CEO, Syntara Limited

Okay.

Cameron Billingsley
Company Secretary, Syntara Limited

Another question from Mr. Mayne. The five most valuable US tech stocks, Microsoft, Apple, Amazon, Alphabet, and NVIDIA, are together worth more than $20 trillion, largely because they have enormous pricing power and are overcharging customers the world over. Could the CEO comment on which of the big global technology companies we are most reliant on, and what would we do if they suddenly put up prices by 30%?

Gary Phillips
CEO, Syntara Limited

I'm not quite sure of the intent of the question, whether the question is which of the big global technology companies Syntara is reliant on, rather than a sort of general me as a consumer. But I think, yeah, we work with a large range of suppliers. I wouldn't say that we were overly reliant on any one of those individual big tech stocks. We work largely. The major expenses that the Company incurs are with what we call contract research organizations who run our very large clinical trials. That's where the bulk of the money that we have goes in taking. We routinely go out to tender with three or four of them before we decide which one. It's a very competitive market. So, I don't believe that we're exposed as a Company to those really large tech stocks and them putting up prices.

Cameron Billingsley
Company Secretary, Syntara Limited

Thanks, Gary. Another question from Mr. Mayne. Thank you for disclosing the proxies early to the ASX with the formal address. The only material protest was around 40% on this item, referring to resolution four. Did any proxy advisors recommend against this item, and what caused the protest vote? Will you change the incentive scheme structure in light of this protest vote? And Gary, just for your context, the resolution four is a resolution for approving the terms of the employee incentive scheme.

Gary Phillips
CEO, Syntara Limited

Okay. Yeah. We didn't have any proxy advisors that recommended against any of the motions. I think this particular vote relates to one very supportive shareholder, and they had an internal preference to approve all of our equity issuances as they occur rather than in advance. But they support and voted for the remuneration report. So, I hope that clarifies the situation with that particular question.

Cameron Billingsley
Company Secretary, Syntara Limited

Thanks, Gary. And the next question from Mr. Maine. We have around 4,500 shareholders, and Platinum is our second largest shareholder with 17%. This is an unusually large position for a listed stock picker to take. What is the history of Platinum's investment, and what sort of influence do they have over the Company? Also, when disclosing the outcome of voting on all resolutions today, could you please advise the ASX, sorry, how many shareholders voted for and against each item, similar to what happens with a scheme of arrangement? This will provide a better gauge of retail shareholder sentiment on all resolutions and insight into the chronically low retail shareholder participation rate. The likes of Qantas, ASX, Suncorp, Tabcorp, and Computershare all do this already. You've got the data, so why not let the sun shine in?

Gary Phillips
CEO, Syntara Limited

I might take the first part of that question on the history with Platinum. And then maybe, David, you could pick up the bit about the standard reporting.

David McGarvey
Company Secretary, Syntara Limited

I think we'll take that on advisement. I think it's correct. We'll have the data. I mean, I don't think we're in, well, I like to be compared to some of those larger players. I think we play at another end of the market. That's not a reason not to be disclosed, but we'll have a discussion about that one.

Gary Phillips
CEO, Syntara Limited

Yeah, we can talk to the registrar about that.

David McGarvey
Company Secretary, Syntara Limited

Yeah.

Gary Phillips
CEO, Syntara Limited

So, Platinum are indeed our second largest shareholder. It's a shareholder that I value because of the fact that they are a specialist healthcare investor and that they do do a lot of diligence before they come in. So, I think I'm often able to point to the fact that Platinum have invested to shareholders who are not as confident in investing in biotech, to look at other people where the smart money is and that they've come in. Platinum, I think in terms of their appearance on the register as a major shareholder, would have appeared probably two or three years ago. They built a position that was around about 8%. And then in the raise that we did in December last year when we initiated this current study and we had the first patient in, increased the, they're holding at that time to where it is now.

In terms of, I think some of your question was about the power that they exert or the influence that they exert. I talk to all of our shareholders as often as I can, and I certainly, the ones that have an insight and Platinum Investment, as I mentioned, were significant shareholders. I understand in other companies that have had myelofibrosis assets that have gone to market. So, their understanding of the investment market and actually the industry around that is a valuable source of information for me, and it's something which I take the time and trouble to listen to them when they're willing to share their insights with me.

I wouldn't say that that gives them power in the Company, but it certainly—I use their knowledge to my best ability to guide the Company in the development path we've taken on and in networking potentially with other contacts that they have within the industry that can help us in our future looking at partnering of the drug, which is one of the Company's options going forward once we have an FDA decision on whether the drug is suitable for going into a pivotal phase II/III study. Are there any other questions, Cameron?

Cameron Billingsley
Company Secretary, Syntara Limited

No, there are no other questions on Lumi.

Gary Phillips
CEO, Syntara Limited

Okay. Thank you.

Cameron Billingsley
Company Secretary, Syntara Limited

And Gary, just as a bit of background, David's had a technical issue, so he's dropped off. So, in terms of moving on to the next slides, we're just going to get Matt to take over the slides. Matt, are you able to bring up that slide deck?

Speaker 8

Yeah, bear with me, Cameron.

Cameron Billingsley
Company Secretary, Syntara Limited

Thank you. Sorry, everyone, if you wouldn't mind just pausing for a moment while we resolve this slight technical issue. Thanks for your patience, everyone. The slides are just coming up now. So, that's where we're at. We're at the next slide, Matt. Thank you.

Gary Phillips
CEO, Syntara Limited

Thank you.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Okay. We're ready, Cameron. Should I?

Cameron Billingsley
Company Secretary, Syntara Limited

Yes, please, Kathleen, if you can start again.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Absolutely. Thank you. So, we will proceed with the formal item of business. So, the first order of business. Am I expecting slides to move on? Okay. The first order of business is to receive and consider the financial report, director's report, and auditor's report of the Company for the year ending the 30th of June, 2024.

These reports are contained in the statutory annual report of the Company, which I tabled before the meeting. Are there any questions? There are no questions. No questions. As this matter doesn't require a vote, I declare that the financial report, the director's report, the director's declarations, and auditor's report for the financial year ended the 30th of June, 2024, have been received and adopted by the meeting. Resolution one. Resolution one is an ordinary resolution that relates to the adoption of the remuneration report. The remuneration report describes the approach taken by the board in relation to salary reviews, short-term incentives, and how they relate to corporate performance and the granting of equity. The vote is an advisory vote, and voting exclusions apply. The proxy votes received prior to the meeting are displayed. Next slide, please, Matt. Next slide, please. Yes. Thank you. Thank you. Are there any questions?

Cameron Billingsley
Company Secretary, Syntara Limited

There are no questions showing, Kathleen.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Thank you. 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, as the next resolution relates to my reappointment, I'm going to hand over the chair to Gary. Thank you, Gary.

Gary Phillips
CEO, Syntara Limited

Thanks, Kathleen. So, resolution two is an ordinary resolution that relates to the reelection of Dr. Kathleen Metters as a non-executive director of the Company. So, before proceeding with the resolution, I'd like to ask Kathleen to say a few words about herself.

Kathleen Metters
Non-Executive Chair, Syntara Limited

So, yes, it's a great privilege to stand for a reelection to the Syntara board of directors as both a non-executive director and as chair. I realize some of you on the call may have heard a little bit about my background before, but for those of you who are potentially joining for the first time or are not aware of my professional experiences, I just want to start by sharing a little bit of my background. So, I graduated with bachelor and postgraduate degrees both in biochemistry from Manchester and London in the United Kingdom. And from academia, I joined big pharma, joined Merck, and spent 25 years plus in the company leading progressively larger research teams studying disease mechanisms across all disease areas. And my final position with Merck was as head of worldwide basic research, and that was based in the U.S.

During this time, it allowed me to become very conversant with many disease areas and many ways of developing assets, small molecules, biologics, and other modalities with which to treat high medical needs. Just one vignette. During this time, I was involved with development of several important therapies. The most rewarding of these to me personally was Singulair, and Singulair is an oral therapy for asthma and allergy. In this case, I was directly involved from initial testing, literally was the first person to test it, through clinical development, and then later to commercialization, launch, and post-launch clinical trials. This gave me really invaluable experience in all aspects of the pharma business, from the very first stages of discovery right through to running a commercial brand. Finally, upon leaving Merck, I was appointed president and chief executive officer of Lycera.

Lycera was a small U.S.-based biotech company, and there we successfully built a pipeline that attracted 100 million plus worth in financing. I'm now continuing to contribute to biopharma through selected board positions such as Syntara, which I joined in 2017. Why did I join? I was and remain attracted to the Company for many reasons, but I'll mention three. The pipeline, which continues to emerge, has multiple innovative research programs, as you've heard from Gary's address, and these have the potential to be life-changing. A world-class and highly motivated research team, and I don't say that lightly, they have strong technical know-how and have built extremely deep and meaningful relationships within the scientific community, particularly nationally. The whole Company has a commitment to scientific excellence. My career, as you've heard, has been dedicated to discovery and to clinical sciences.

And as a board member, I bring breadth and depth of experience in every aspect of the business, every aspect of research and development to this team. Over the last years in the Company, I've served on the remuneration and nomination committee and the audit and risk committee, both of which I chaired before serving as chair of the board. So, I'm very familiar with all aspects of the Company. And finally, I think it's worth saying that my commitments are such that I do have the bandwidth to fully contribute to the Company and have no conflict of interest in doing so. So, as you heard from my address as board chair, Syntara is an incredibly exciting stage. This has been reinforced by Gary's presentation, and we are now really eagerly awaiting results from our clinical trials.

And so, I'm truly looking forward to continuing to advise and shape the evolution of the Company to create value for shareholders and for patients and to work with my fellow board members and the team. So, I respectfully submit my candidature for reelection.

Gary Phillips
CEO, Syntara Limited

Thank you, Kathleen. We can show the proxy votes now.

Cameron Billingsley
Company Secretary, Syntara Limited

Next slide, please, Matt.

Gary Phillips
CEO, Syntara Limited

So, they're set out on screen. Are there any questions?

Cameron Billingsley
Company Secretary, Syntara Limited

There are no questions showing.

Gary Phillips
CEO, Syntara Limited

Okay. In which case, I will hand it back to Kathleen.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Okay. Thank you very much, and thank you for your support. So, we move on to resolution three. And resolution three is an ordinary resolution that relates to the grant of performance rights to Gary Phillips as CEO. If shareholders approve the resolution, the performance rights will be granted after the meeting pursuant to Syntara's existing employee incentive plan. The terms of the performance rights are set out in the notice of meeting. The performance rights have a life of 10 years and will vest in two equal tranches at each of the 30th of June, 2026, and 2027, subject to Mr. Phillips being an eligible person on those dates. The performance rights are being granted with the aim of rewarding, incentivizing, and retaining Mr. Phillips in the long term. Voting exclusions apply in respect to resolution three. The proxy votes received prior to the meeting are set out online.

Are there any questions?

Cameron Billingsley
Company Secretary, Syntara Limited

There are no questions showing, Kathleen.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Then we move on to resolution four. Resolution four is an ordinary resolution that relates to the approval of the Company's employee option plan, performance rights plan. The proxy votes received prior to the meeting are set out online. Does anyone have any questions on this resolution?

Cameron Billingsley
Company Secretary, Syntara Limited

Kathleen, noting that Gary already answered a specific question on this resolution, there are no further questions on this point.

Kathleen Metters
Non-Executive Chair, Syntara Limited

Thank you. Resolution five. Resolution five is an ordinary resolution that relates to the appointment of a new auditor. I'd like to take this opportunity to thank PwC for their support to the Company over a number of years and to welcome William Buck as our new auditors. The proxy votes received prior to the meeting are set out online. Does anyone have any questions on this resolution?

Cameron Billingsley
Company Secretary, Syntara Limited

There are no questions showing, Kathleen.

Kathleen Metters
Non-Executive Chair, Syntara Limited

So, thank you. And that concludes our discussion on the items of business. I'm about to close the voting system. Please ensure that you have cast your vote on all resolutions. I will pause briefly to allow you time to finalize those votes. Thank you. Voting is now closed. 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 want to thank everybody very much for attending.

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