Thanks very much, Matt. Thanks for the invitation to speak, and good afternoon, everybody. I guess the question on many people's lips, I mean you're in a virtual healthcare conference, is how do you make money out of investing in healthcare these days? We've had a couple of notable blow-ups in the last 12 months, Opthea and Immutep. Both of those companies with large phase III studies that raised, yeah, well over AUD 150 million in shareholder funds to invest in a study that eventually didn't pan out. Both those companies with basically one asset, so everything was on that. I'm gonna present you a different model. I'm gonna present you why Syntara actually makes great sense at the moment as an investment opportunity.
I think the result from Amplia the other day, with a positive phase II outcome and a doubling of the stock value shows how you can make money here and why, in fact, Syntara, even versus Amplia, has multiple opportunities all at the same stage, all of them coming in the next 6- 12 months. Without further ado, I'll just dive into that. You know, Syntara, as Matt said, we're a clinical stage drug developer. We do have our own drug development group internally, who've developed a pipeline of drugs. You come to us at the point in time when that pipeline has matured.
All of those assets that we've been working on are now in late-stage phase I or phase II studies, and all of them gonna deliver results in the next 12 months in markets which have a very large addressable size, often in the billions of dollars. Multiple shots on goal. The other thing I think healthcare investors think about at times like this, when you've seen some failures and seen some successes is, "How do I know what's going on? How can I understand the science? Do I need to understand the science?" With Syntara, you can look at our investor base, I think, for some comfort there. We have 43% of our shareholder base is institutional. That's very rare for a company of the size we are.
Many of those investors have actually made money in exiting drugs which have been sold in myelofibrosis, which is the lead indication which our lead asset is in. I think you can take some comfort from that. We're also covered by four different banks, so we have coverage from Canaccord, from Euroz, from Bell Potter, and from Evolution Capital as well. It's a well-covered stock backed with smart money with a pipeline which is matured to the point where it's gonna deliver real effective news flow in the next 12 months. We've got about AUD 12.5 million in cash at the end of December. That takes us through to the beginning of 2027. We've got a proven track record in doing deals.
Deals is one of the things I'm gonna talk about is what happens next with our studies. On all of that, in a company which only has a market cap of around about AUD 50 million. Again, the number of opportunities, the number of shots on goal, all of them at that really sensitive area of phase II when you do see appreciation of stock with multiple shots on goal, all in a market cap of AUD 50 million. With that's the pipeline. We've got a drug, amsulostat, in myelofibrosis, already proved itself in myelofibrosis with a phase II study result last year. Two other studies in a related disease, myelodysplastic syndrome, and another one in pancreatic cancer. The MDS studies are due to produce data by the end of this year. The pancreatic cancer study's starting end of this year.
All three of those studies funded by non-dilutive cash, so free hits for shareholders. We've got a skin scarring program in two different studies, again due to deliver data before the end of the year. In the very short term, a drug in Parkinson's disease, a sleep disorder which leads to Parkinson's disease, which is due to deliver data next quarter. Very short term in terms of a potential value opportunity in the stock. I'll just go briefly through those indications and talk about them. I'm not gonna dwell on them in great detail because I wanna leave a bit of time for questions at the end. I just wanna give you a feel for what the diseases are that we're going into, why we think our drugs are exciting and what they're doing there.
Then a little look at the status, what are we expecting next. The lead drug is in an indication called myelofibrosis, which is a cancer of the bone marrow. Your bone marrow is your body's blood production unit, produces red cells, white cells, and platelets. In myelofibrosis patients, that bone marrow becomes fibrotic or scarred, and the spleens get much larger. These patients suffer with quite a lot of symptoms. Many of them go on to develop leukemia. The average life expectancy is around about five years, so this is a fatal disease, an orphan disease, where patients don't have a very good time and unfortunately their lives are cut short. At the moment, the only drugs which are used in myelofibrosis are drugs called JAK inhibitors.
JAK inhibitors are pretty good at reducing symptoms and reducing spleen size, but they're also not very well tolerated. They hammer in all the aberrant cells that are produced in the spleen, hence reducing the size of it, but they also kill off some of the good blood cells as well. Patients on JAK inhibitors typically have what we call hematological toxicity. Their blood gradually deteriorates. Their red blood cells and platelets in particular drop over time the longer they stay on the drug. The clinician has to reduce the dose of the drug until they can't stay any longer and typically when they come off of a JAK inhibitor, they have about 12 months to live.
There's a huge need for drugs which work on top of JAK inhibitors to improve the lives of these patients and potentially change the course of the disease as well. Despite only being symptomatic, JAK inhibitors, they have a market which is approaching AUD 2 billion a year. You know, not too shabby. Also there's a lot of commercial interest. I mentioned that there's a huge unmet medical need. Well, that translates into also a commercial opportunity. The last four deals that we've seen done in exits in this area, the ones that have been done after phase III have been all north of AUD 1.7 billion, exit values. Some of our shareholders were in some of those exits. The FDA and we are interested in two main things about myelofibrosis.
One is the symptom score of these patients, and the other one is their spleen size. I'm very pleased to say that in the results that we've already presented in at the American Society of Hematology at the end of last year, that from a symptom score point of view, 3/4 of our patients in the study had more than half their symptoms between the start of the study and then after six months. The study itself ran for 52 weeks. Those patients that stayed in after six months, more than half their symptoms, 3/4 of them. That's almost double what we've seen with other drugs in similar studies, open label phase II studies in this particular patient group, which were patients that are on a JAK inhibitor, ruxolitinib, but aren't doing too well.
That really has got everybody sitting up and taking notice of the drug. Then when we look at spleen volume, we find that about half the patients had a spleen volume reduction of 25% or more. Again, that's competitive with what we've seen with other drugs in the marketplace. It certainly stands out. If you put those two measures of efficacy together with the safety profile of the drug, which I'm also pleased to say is pretty good. We haven't had any serious adverse events related to the drug in either of the studies that we've done so far. Despite these patients being on other drugs and being quite sick, the drug looks really well tolerated, which is what you'd expect from the mechanism that it has. That really makes it stand out.
It's very well differentiated at this point in time. What's next? Well, with those two efficacy endpoints, improvements in symptom score and improvements in spleen volume, the patients that finished the study also chose to stay on the drug, which is another healthy sign. We're now in discussions with global regulators and primarily the FDA to design the next study in this drug's development. When the FDA give us the approval to go on to the next study, that's also the trigger point for us to enter into partnering discussions with global companies who are interested in what we're doing to test to see whether this drug has a commercial value now before we go on to the next study. We're expecting that approval from the FDA in quarter two this year. Just next quarter.
Just around the corner. That, as I say, will lead to discussions with potential partners. I mentioned at the beginning the amount of commercial interest that there is in myelofibrosis, and these are the last four deals that have been done in myelofibrosis. The two on the right are for other JAK inhibitors that have a slightly different profile from the lead one that's in the market. AUD 1.7 billion, AUD 1.9 billion. Both Sobi and GSK are companies that we're talking to about our drug now. We have got investors in our company that were investors in both CTI and Sierra as well. The one in the middle there, Novartis, pelabresib is not a JAK inhibitor. It works via another mechanism. It produced good results in phase III.
Novartis bought it in February 2024 for $2.9 billion after phase III. It went on to have some safety issues that emerged after they bought it, wiped $800 million of asset value off of their balance sheet. Now it looks like it's got to do another very large phase III study in order to make it to market. That drug has tolerability issues. It does work in this patient group. We think the market really has opened up for us. You know, the profile that we have with amsulostat, good safety, good efficacy in symptom score and spleen volume, will still be very well differentiated from these things that are in the market. The last one, perhaps more aligned with where we are now.
Takeda bought Keros in December 2024. $200 million up front for a drug that had completed phase II. The total deal value of $1.1 billion. As I said, this area extremely commercially attractive. There's more than one string to the bow of amsulostat. It's not just about myelofibrosis. The drug has also proved to be very effective in preclinical studies of another blood cancer called myelodysplastic syndrome. This is a related disease. I mean, this is also one of the bone marrow where there are problems with the hematopoietic stem cells, and they get dropping red cells and white cells and platelets. It's a larger market than myelofibrosis.
Because of the interest in this and because of some very exciting preclinical data where we showed that if you add on amsulostat on top of the existing standard of care in this area, you see a rapid improvement in red cell production. We got funding from two different groups, one from the Australian government MRFF to conduct a study in Australia of MDS patients and one from the German Cancer Aid to conduct a study in Germany of high-risk MDS patients. Both those studies are underway. Both of them are recruiting at the moment, and we expect to see interim data by the end of the year in MDS. If we do see a positive outcome in either of those studies, that will reinforce the commercial value of amsulostat, and that in fact doubles the value of the asset to a potential acquirer.
Really excited to see those studies underway. Looking forward to seeing the results. A bit of a free kick for shareholders as well, in the fact that they're not paying for those studies to undergo. Now that same mechanism, the anti-fibrotic that we used in myelofibrosis, we've translated also into skin scarring. We have a cream which contains the same, a drug which targets the same enzyme, lysyl oxidase. In this case, it's used to stop emerging scars on the skin or reverse a bad scar that's on the skin. Scarring is a huge global phenomenon. More than 100 million new scars annually post-surgery. The explosion in cosmetic surgery means that there are more and more patients having scars which they're particularly sensitive about how they both look from a cosmetic perspective and also how they function.
Do they restrict movement in the skin because they're different? They also lead to a strong psychological impact as well, scarring on the skin. There are no FDA-approved therapies for scar treatment or remodeling. Current standard of care is to use laser therapy or silicone-based products. These have some benefit in patients who scar more mildly. There are many, many scars which these things are not effective for, and there's a huge need for something which would do it. I'm pleased to say that we have a long-standing program in skin scarring and one which we've been working on with Fiona Wood over in UWA in Perth. They've taken one of our drugs, formulated as a cream, applied it to patients that had a skin scar that was on average 13 years old.
This study was placebo-controlled. In that group of patients, when you apply our cream for three months, we saw a 30% reduction in collagen content in the scar and an improvement in vascularization, the blood flow through the scar in those patients compared to placebo. In Fiona Wood's words, this was an unprecedented finding for a drug being used in scarring. It's really exciting for the whole field, and we have many clinicians that are interested in what we're doing. We're now engaged in a study, I think the study, which will unveil how effective our drug can be in changing the course of scarring. This study is underway at the moment. It's recruiting now. It's in patients that have a sternotomy scar, so they've had open heart surgery and have a long straight scar in the middle of their chest.
That scar tends to scar quite badly in patients who are sort of prone to bad scarring in that every time you breathe, you're putting the center of that skin in your chest under some stress, both backwards and forwards. That stress in itself as the wound is healing and causing a scar tends to promote worse scarring. The advantage of this scar is that all the patients that we will have in the study have the same scar in the same position on their body, and the length of it means that we can apply both an active cream to one area and a placebo cream to another area with a buffer in the middle, which means that each patient will be their own control. I think it's a really innovative design.
We've been working with an opinion leader called Professor Bayat, who really, I think, understood what we're trying to do. He's very engaged with the mechanism that we have and believes that this lysyl activity, this lysyl oxidase enzyme activity, sits at a mechanistic root of scar persistence, and its involvement is consistent across scar types. If we inhibit lysyl oxidase, we see meaningful structural reversal in human studies, which Fiona Wood has done, and we're looking to now show that impact on the appearance of scars. We've got many different endpoints in this study, and we expect to see some results from that by the end of the year. Lastly, not least because it's just around the corner, we've got a study underway in Parkinson's disease. This is a drug which is used to treat neuroinflammation.
The patients we've recruited are those that have a sleep disorder, a severe sleep disorder, which means that when they go into rapid eye movement sleep and REM sleep, they start to act out their dreams. They actually become verbal, they shout, they scream, and they move around as well, and often thrash around. More than 80% of these patients go on to develop Parkinson's disease or Lewy body dementia, which is a sort of severe form of Parkinson's. We've known about this for 20 years, but it's only recently I think we've had the prospective studies that have really identified that this is a group that can be studied and one that we could try and change the course of the disease. We have a study underway.
It's fully funded by Parkinson's U.K. to the tune of $ 5 million. Again, another free hit for shareholders. 40 patients, with three of them, every three that are on active, one is on placebo. This study is fully recruited, and we expect a result from this in quarter two. We're looking to see whether the drug is safe versus placebo, and we're looking at measures of sleep quality as well. Outcomes from this study and why we're excited about it is it will be the first drug which is available, which would target this particular group of patients.
They currently use melatonin or sedatives, which don't really have much of an impact. A really exciting disease area, one which has got commercial attractiveness written all over it and a result just around the corner. Just to recap that news flow, lots of it to come in quarter two and then the second half of the year. That FDA-approved clinical development program for amsulostat in the next quarter, together with top-line data out of the Parkinson's disease study. Then the second half of the year, we're seeing interim data coming out of that MDS, two MDS studies, one in Germany, one in Australia. The skin scarring program as well, and the pancreatic cancer study starting up.
If you're looking for an investment in a biotech company with multiple shots on goal, coming off a very low base at the moment, then put us, Syntara, on your watchlist. Matt, I'm happy to take any questions you've got.
Thanks, Gary. Yes, you've certainly got plenty on the cards. We'll jump into some questions and get through as many as we can in the five minutes. There's a couple of questions, both in the lead-up and during just around recruitment progress on skin scarring. I know you touched on it there, but can you just, I guess, reinforce where that's up to?
Yeah. We're expecting Fiona Wood has a study running in patients with keloid scars. I understand that's well advanced in its recruitment. As we've said, we are expected to see some results from that in the second half of the year. Also our study in hypertrophic scars that started at the beginning of the year. It's got two centers, one in Brisbane and one in Perth, and recruitment is underway at the moment. We'll give updates on that as it progresses through the recruitment process. Again, at the moment, I think shareholders should think of this as seeing results in the second half of the year.
Following on from that, has there been any commercial interest demonstrated for the skin scarring products, or are we not quite at that stage yet?
Yeah. I've talked to a number of skin of dermatology companies over the last couple of years, actually. Soon as we started to see the results emerging out of Fiona Wood's group, we immediately attracted interest. A lot of these companies, you know, they. AbbVie is a good example. They have an aesthetics division. They sell Botox. You know, they've got a large sales team visiting clinics which are doing cosmetic surgery a lot and where there's an obvious need for a product which can help them with patients with scars as well. So there's no shortage of interest and a lot of companies looking there. Everybody's trying to find a pharmacological mechanism which will make a difference in scarring.
You know, Professor Bayat, if anybody is interested, go back and look at the webinar we hosted in November last year with him. It was a tour de force of, you know, why this mechanism should work and the interest that there is in it. You know, we have a number of companies that are following what we're doing and, but quite rightly, need to see an outcome from the clinical study before they sharpen their pencil. I think the interest will be there, and it'll be strong.
It seems the skin scarring is the flavor of the question time. Someone else has asked, has the skin cream been used on patients with mastectomy?
No, we haven't. Now, it is a scar which could be used. When we try to find a scar that we can use in clinical trials, our problem is that scars are different in between patients, so everybody scars differently. In fact, each individual patient scars differently depending on whether the scar is on their elbow, on a joint which is flexing or on an area of the skin that's not under stress. We look for something where we could have the same scar in everybody and then find where we could do the same thing. Mastectomy was a candidate for that because particularly if it's a double mastectomy, you could have applied active to one side and placebo to the other.
In the end, we felt that sternotomy scar was the right thing to do. Once we demonstrate it in a sternotomy scar, there is every reason to believe that a mastectomy scar would respond in exactly the same way, to the treatment. I'm very optimistic that, you know, if we do see a result in this, it would translate to mastectomy scars.
In terms of amsulostat and the myelofibrosis trial, what level of efficacy would you consider clinically and commercially meaningful in the phase II-B?
I think it's very clear. The discussions with the FDA that we've had and are ongoing now, the symptom score is the thing that they really want to see and improvements of more than 50% in those patients. We had one phase III study published this morning from a company, with a drug called selinexor. They hit their endpoint in terms of spleen volume, but entirely missed with the symptom score. They didn't see any improvement in symptom score compared with placebo. I think that will struggle with the FDA. I think regulatory-wise, you need to show a benefit in symptom score backed up with some change in spleen volume. The other way around doesn't work. You know, if you have spleen volume, but you don't have symptom score, that won't work.
I think competitively in the marketplace, if we can demonstrate, you know, a 40% improvement of patients getting a symptom score of more than 50% improvement on top of a JAK inhibitor, then we will be doing well. We saw 75% in that phase II-A study that we've completed. I think, you know, we've got reasons to be enthusiastic, and that but that needs to be repeated in the next study.
Just one last one. You speak about potential to partner. Do you think there's any situation where you might look at full commercialization yourself, or would partnering always be the preferred strategy?
I think the company has the benefit of having multiple assets currently in the pipeline. In all probability, we will have a mixture of products going farther and products being partnered earlier. The funds that come from products being partnered earlier will help fund those products which we take farther. This will be an emerging strategy and one that we'll, the board and I, the management team will look at as we see the results coming through towards the end of the year. As we see, we test the market.
You know, we will be out there, as soon as we get an FDA agreement on the clinical trial protocol, engaging with something like 20 companies to see what interest there is and whether there is partnering value in here now or whether we should go farther. Likewise with the skin scarring and the Parkinson's disease drug, when that drug comes through. We will explore it. We're certainly open to doing partnering now. We'll explore and see what the value is.
Very good. Well, we'll look forward to hearing more on all that, Gary. Thanks for your time today.
Pleasure. Thank you very much, Matt.
Next up in about five minutes, we'll have the next presentation as part of the conference, which will be from Emvision. Hope you can all join us there. Thank you.