Thanks for standing by and welcome to the Syntara Investor webinar for the quarter-ended March 2024. All participants are in a listen-only mode. There will be a presentation provided by management followed by Q&A based on questions submitted live during the session. If you'd like to submit a question, please do so using the Q&A function within Zoom. On the webinar from Syntara today, we have the CEO Gary Phillips and CFO David McGarvey. The presentation will last for approximately 15 minutes and then we'll take questions. Gary, I will hand it over to you.
Thanks, Matt. Welcome, everybody. Thank you for sparing me your time this morning. I know this is the final day of reporting season, so thanks for sharing a few minutes with you. As Matt said, I'll run through the highlights of what we've done in the last quarter and look ahead to a very busy couple of quarters coming up in terms of news flow and try and orientate you in terms of the things that you should be looking for going forward. Clearly, the key investment for the company and the key asset and milestones that will drive an increasing value in the company is our lead asset, SNT-5505, and its study in myelofibrosis.
As I've described in the quarterly update, my editorial, there are things which drive value and we need the cash to get to the point where we're delivering results on meaningful phase 2 studies. The myelofibrosis phase 2 study is meaningful. It's already gone past the FDA twice, once for the monotherapy study, which we've already reported on last year, and now to get approval to start the study, which is a combination with the standard of care, ruxolitinib. We have 19 trial sites open in this FDA IND-approved study in Australia, Korea, Taiwan, and the U.S. I'm really pleased to say that the study is recruiting well. As at the end of April today, we are 60% recruited of the 15 patients that we're looking for, nine have been recruited. That means we're well on track to complete the recruitment by the middle of 2024.
Now, that's important. It sets us up nicely for the largest hematology meeting globally, which happens every year at the American Society of Hematology, which is in the first week of December. So this study, to remind you, is an open-label study. We're hoping to recruit all patients before the middle of the year. That means we will have six-month data from many patients to report at the American Society of Hematology in the first week of December. That is a key milestone, a deliverable, and one thing that will drive value going forward. So that's a really exciting thing to look forward to in the year and one which the company is really executing at the moment on the plan that we have.
I was also delighted in this last quarter to announce that we have attracted a government grant from the Medical Research Future Fund, the MRFF, an Australian government grant, to work alongside the University of Newcastle and the Australasian Leukaemia and Lymphoma Group to deliver a study in myelodysplastic syndrome. Myelodysplastic syndrome is another hematological malignancy, a cancer. It's a disease which sits well alongside myelofibrosis, SNT-5505. It's a disease which the companies which are following us and tracking us in terms of results from the ongoing study at the moment are also commercially extremely interested in, and it will add commercial value to the company as we start to recruit that study and look to produce results in the middle of 2025. That study is due to start recruitment in the second half of 2024. It's going in as a first-line treatment on top of standard of care.
So again, an exciting development and one which the shareholders of Syntara get for very little investment. The grant from the government covers a lot of the costs. The Syntara costs of AUD 700,000 over a period of three years. So a really good value for shareholders. And then lastly, I think we announced, obviously, in the last quarter that we were selling that we had sold the mannitol business. And I just wanted to report back one quarter later that the cost reductions that we forecast of AUD 14 million per annum are on track. Everything that we're seeing at the moment going through the accounts. It's quite a complicated business to separate the mannitol business from the rest of our business, but we're, if anything, ahead of schedule.
Full responsibility for all the costs of the mannitol business unit, other than the lease we have on the facility, have already been transferred to the acquirer of the mannitol business, Arna Pharma. That facility lease is expected to transfer in the current quarter, which means that from the next quarter onwards, we will be fully separated. So the impact of those cost reductions is felt already. And I'll talk to the cash flow a little bit later in this presentation, but it sets us up well and puts us in a strong position to deliver on the clinical trials that we're currently engaged with. So for those of you that might be slightly new to the Syntara story, the lead asset, as I mentioned, SNT-5505, is in a hematological malignancy, a blood cancer called myelofibrosis. This is a fibrosis of the bone marrow.
The bone marrow is the body's production unit for red cells and white cells and platelets. So when it becomes fibrotic, then that causes patients' problems. Their average life expectancy is around five years. The current standard of care is a JAK inhibitor. JAK inhibitors treat the symptoms of myelofibrosis, but they don't lead to any significant survival improvement. They're also very poorly tolerated drugs. 75% of patients come off of these drugs within that five-year period. And once they come off, the median survival rate is only just over a year. So this is an area of very high unmet need, one where there's a great need for new products to work alongside JAK inhibitors, and one where there's a great deal of commercial interest as well. There have been several exits from companies developing drugs in myelofibrosis in the last three years.
All of those exits with phase 2b, phase 3 data have been north of AUD 1.5 billion a year, but AUD 1.5 billion acquisition value. So this is an extremely valuable area and a disease area which is attracting interest and one which we're focused on delivering the next big thing in this area. So the study we've already reported on was in a monotherapy sense. So the FDA requires us to show efficacy and safety in a monotherapy sense before we go on to combination therapy. Monotherapy patients are end-of-life, so they've got, as I said, about 12 months to live when they come off of a JAK inhibitor. We reported on this study at the American Society of Hematology in December last year. And the drug was extremely well tolerated, which is unusual in myelofibrosis clinical development.
Many of the drugs, nearly all of the drugs in development, the ones on the market, cause cytopenia or low blood counts. This is why patients have to come off of them. Our drug doesn't do that. It works in a completely different and novel mechanism than any other drug in this disease category. And not only was our drug safe, but it also showed encouraging signs of clinical efficacy. Half the patients showed that the patient's bone marrow fibrosis reduced. So that bone marrow is being replaced with normal functioning bone marrow, which is then reestablishing itself and producing red cells and platelets again. And indeed, we saw improvements in both symptom score and red cells and platelets for these patients that completed the study. So a really encouraging start. That was the data we took back to the FDA in quarter three last year.
They then approved this study, which is ongoing at the moment, which is in 15 patients. These are patients who are on a stable dose of a JAK inhibitor, ruxolitinib, the leading drug in this area with sales of more than AUD 1 billion a year in myelofibrosis. We're looking at safety, but also the endpoints that we had in the first studies, looking at platelet counts, red cell counts, symptom scores, the amount of fibrosis in these patients. These patients, we're going to follow them for 12 months because we saw even at the end of the sixth-month study in monotherapy that patients were still improving. But the sixth-month data is what the FDA are interested in. It's the sixth-month data that we will present at ASH in December this year. Then the 12-month data by the middle of next year.
That interim data, we expect to prompt a discussion with the FDA on the pivotal trial design for this drug to get into its registration study. So a really important period for the company. We expect to be fully recruited by mid-year and with data coming out in December. So just to summarize, I'm not going to go over the whole of the pipeline, but Syntara are a company that's unusual in biotech circles in Australia in that we do have a pipeline. An investment in Syntara is not an investment in one asset, one clinical trial. We have a number of assets going forward and many of them in phase 2 trials that are due to deliver results within the cash window that we have. So I've talked about the myelofibrosis study, the myelodysplastic study, which is due to start recruiting towards the end of this year.
With some data coming from that, we expect by the middle of next year within the cash window. We have a scar prevention and scar treatment program ongoing with Professor Fiona Wood at the University of Western Australia over in Perth. We've got a study at that point which is open for recruitment, which is in patients with burns, looking to prevent bad scars in patients with burns. And we're also in discussion with her about the topical treatment following on from the positive results we had from a study last year in looking at modifying existing scars in patients with a topical treatment delivered daily. And finally, a study in neuroinflammation where we have a drug again in phase 2, which is treating a sleep disorder which leads to Parkinson's. Most of these patients end up with Parkinson's. We're recruiting that study at the moment.
The site in Australia is open and recruiting. We have 3 patients recruited. It's a double-blind placebo-controlled study. The U.K. site is due to open this quarter. And we expect to see an acceleration in the recruitment rate from that study and again with data around the middle of next year. So a really exciting period for the company. I'll just take you back to the cash. So the cash balance at the end of March was AUD 7 million. However, we are expecting additional funds that come from the transition of the mannitol business and the return security deposit when we give up the lease from the facility that we have, which will add a further AUD 6 million to that cash balance. And then also a further R&D tax credit later in the year.
That together with the fact that I mentioned that we're on track at reducing the cash expenditures arising from december , which we forecast and now fully expect to be AUD 14 million per annum, means that we have cash that takes us through to the middle of 2025. So off the back of the capital raise, which we did in December last year, we have a really strong register. The investors that have taken a part in Syntara, many of them are specialist healthcare investors, some of them with a history in myelofibrosis who've made money from investing in companies in this disease before. So we're really delighted with the institutional register that we have. We recognize that the share price in the enterprise value at the moment is extremely low for a company with assets which are delivering phase 2 trial data within a cash window that it's got.
So we're looking forward to the next 6-12 months and looking at an appreciation with several different shots on goal coming from the pipeline that Syntara has and the trials that it's running. Just to finish on the news flow, I think you know whenever considering investment in biotech companies in particular where the product development timelines are quite long, the quality of the news flow is all important in terms of thinking of potential value appreciation in the coming period. So we expect within this quarter still to be reporting a commencement of recruitment in that study with Professor Wood in Perth for the prevention of scars coming from burn injuries. These are patients that will have full-thickness burns and having skin grafts. We expect to report, I think most importantly, that we have completed recruitment of the myelofibrosis study in combination with ruxolitinib.
That will put the company on a time clock to the reporting of the interim data with six months of data, which we'll come to later in the news flow. Also in the middle of 2024, we expect to announce further expansion and talking about the clinical trial development program for our topical skin scarring product, followed by an update on the recruitment in that sleep disorder, Parkinson's disease study that is fully funded by Parkinson's UK. And then in the second half of the year, we'll start commencing recruitment in that myelodysplastic syndrome one, again, that study which has got great commercial value to potential acquirers of the asset once we have data from the myelofibrosis study. And then publication of the monotherapy data that we talked about at the American Society of Hematology last year.
Then most importantly, the data from the myelofibrosis combination study being presented for the first time at the American Society of Hematology in the first week of December. So news flow there and that last one, the study is open label, so we will have data there providing our abstract is accepted. We will be presenting an update at that time, the first week of December. So you can count on that. So with that, Matt, I'd like to just finish my presentation and I'm happy to take any questions.
Thanks, Gary. As you mentioned, we'll move on to the Q&A. Again, the questions will be based on any sent through using the Q&A function within Zoom. So anyone in the audience, if you have a question, please feel free to type it in. Gary, the first question is, you provided the latest update with regards to the neuroinflammation study.
Sorry, an update on the neuroinflammation. Yeah, yeah. So that's a really, I don't get much time to talk about that study. Our focus is on the hematology one, and we're not a CNS company. So the neuroinflammation study comes from a drug which the company already sold once. This is an asset which we sold to Boehringer in 2015. The company was paid AUD 86 million over the time period that Boehringer had it. It went into phase two studies of a liver disease, fatty liver disease called NASH. Boehringer handed it back to us three years ago. They did so because the drug had an unexpected impact on an enzyme in the brain which wasn't picked up in the phase one studies. Now that made it unsuitable, not unsafe, but unsuitable, commercially unsuitable for development in liver disease.
But when we showed that drug to neurologists, they said, you know this off-target effect that you have on brain inflammation makes it almost the perfect neuroinflammation drug. And they were looking for something that could lead to slowing neurodegenerative diseases like Parkinson's, Alzheimer's disease, Huntington's disease. Now these patients with iRBD or isolated REM behavior sleep disorder, these patients act out their dreams. They become very violent, actually, during their dreams. But probably more than 80%, probably more than 90% of these patients go on to develop Parkinson's disease. So it's a disease which is a very strong indicator that you will have Parkinson's in the future.
If we can treat the inflammation in these patients, not only do we have a commercial opportunity to treat patients with this sleep disorder, at the moment these patients only are treated with melatonin or sedatives, a very unsatisfactory way of treating them. But these patients go on to develop Parkinson's. And if we can treat their inflammation, there's a chance of slowing down or stopping the progression to Parkinson's. So this first study is a double-blind placebo-controlled study, two sites, one in Australia, one in the U.K. It's fully funded by Parkinson's UK, majority funded by Parkinson's UK. They invested AUD 5 million in this study. They do get a commercial return if the product is successful with a royalty on any income that we get up to a cap four times the investment they make.
So a very, very good deal for the company and its shareholders and one which we hope to see data from by the middle of next year. So again, quite a bit of interest from companies out there in CNS and sleep disorders and neurodegenerative diseases all waiting to see some data and data within the cash window that we've got. So I'll get a chance to talk about it, but it's a really well-developed drug. It's a really nice indication with a very clear endpoints in the studies that we're doing, a placebo-controlled study fully funded by somebody else outside of the shareholders. So it's a really good deal for Syntara shareholders and another shot on goal.
Thanks, Gary. Of a similar vein, can you provide an update on the status of the skin scarring study?
Yeah, so the study which Professor Wood was really excited about was the opportunity to treat the patients she sees a lot of, which is patients with burn injuries. These patients have often 5% of their body surface area or more involved in the burn. They always have to have skin grafts and the scarring that comes from skin grafts is often, frequently in these patients bad and leads to further problems down the track. They often need to have repeat surgeries. They often need laser therapy to improve the scarring process going on. In her words, finding something that these patients could take after the treatment, after the burn surgery had healed, to stop the scarring would be gold dust for her patients.
So the study that's open at the moment is to treat those patients probably within a few weeks after their surgery has happened and the wound has had a chance to heal, to be taking our antifibrotic at that time and then following these patients for six months and then assessing their scars at the end of that period. We have two sites, one of which is open in Perth and the other one in Brisbane. We expect to open in the next couple of months to recruit 60 patients in that study. And we'll announce more details on that study once the first patients are recruited and we have a chance to do a bit of a deeper dive on it. So that's the one aspect of the scarring program.
The other one is to build on the study that we reported last year, which is a topical treatment of patients with existing scars and modifying. And if you remember, those patients that we treated for three months with a topical LOX inhibitor saw a 30% reduction in the collagen in their scars. Patients had pretty old scars, an average age of 13 years, the scar. So we felt that while we made a really unprecedented change, Fiona Wood's terms, unprecedented change to the structure of the scar, we didn't see much change in the appearance of the scars. And we think that's down to patient selection.
We're currently reviewing with Professor Wood and our colleagues, which is the right patient group to be using a topical scar treatment in, probably patients with younger scars, with hypertrophic scars following surgery, but ones that we can accurately measure and quantify going forward, either as a prevention or as a treatment for those scars. That's something we'll update the market with again when we've got more details on it, probably in the middle of the year.
Thanks, Gary. And as a follow-up to that question, someone's asked around commencement and does the patient criteria have a specific impact on the rate of enrollment for the study?
Yeah. So the entry criteria to that study is that patients have to have a burn that requires a full-thickness burn that requires a skin graft that is over a certain percentage of their body surface area. And we've tried to define it within a certain age group as well. These patients, both Perth and Brisbane, see a lot of these patients each year. We're looking at the last few months of patients going through Perth to assess whether those entry criteria need to be widened at all to capture more of those patients. So that's an ongoing discussion that we have with Professor Wood and our colleagues.
Thank you. Another question that's come through was just with regards to the cash window you mentioned and the results being delivered in that time. Can you just elaborate on that a bit in terms of does that mean 9 months or what does the cash window, where does that take you to?
I think it's important to understand this, actually, so because if you look at the last couple of quarters of cash, it is a mixed picture with the separation of the mannitol business and the amount of cash that the company has paid on behalf of the new mannitol business that's currently being reimbursed and the impact of the cost reductions that we're making and the dropping the lease as well. So if we take into account the cash savings that we've made, which, as I said, is estimated and now forecast firmly at AUD 14 million per year, and we add that to the cash we already have and the additional cash that is still expected to come into the company, that takes us through to the middle of 2025.
So our cash burn is down to around AUD 1 million a month, we expect, which is covering, I should add, all the expenses involved in all of those phase 2 clinical studies that we've just talked about. So it's a remarkably efficient company at the moment. Our staff numbers are down to below 25 now. The rent that the company is paying has dropped from over AUD 2 million to under AUD 200,000 a year. All of these things have contributed to really making the cash that we have go a lot, lot farther and delivers us well beyond the December time point when we'll have interim data from that myelofibrosis study.
Actually, the middle of the next year where we're expecting to see the 12-month data from the MF study, interim data from the myelodysplastic syndrome data, and some data also from the skin scarring study and the sleep disorder study as well. A remarkably efficient engine producing data and news flow with cash to take us out to that middle of 2025 point.
Thank you, Gary. I've got no further questions, so I'll just allow you to provide a concluding comment.
Yeah, so I think in conclusion, it's been great to have the opportunity to update you on the last quarter. It's encouragingly reassuring, I believe. We're delivering on the cost reductions that we said that we would do in a very major way. Syntara is a completely re-engineered, restructured company with a very different business model from Pharmaxis and one with an incredibly rich pipeline, which is currently with its lead asset in myelofibrosis doing what we said that we would do and is well on the way to recruitment to be 60% recruited at this point. [It] puts the company in a really strong position to complete recruitment by the middle of the year and deliver on significant data in that first week of December. I'm looking forward to that and hopefully at the next quarter, the update around the middle of the year, we'll be talking more about that recruitment rate and what we're seeing in the data.
Thanks, Gary, and thanks to everyone for joining, and we look forward to updating you next time.
Thanks very much.