Yes. Good morning, shareholders, and thank you very much for taking the time to listen to this brief. We think when we do a major transaction like this, perhaps not such a material transaction, but certainly a strategically important one that it's worth opening up the opportunity for dialogue. So again, thank you for your time. Skipping through the presentation, which will be shortly posted to ASX and I hope that you can see on the webcast.
Skipping over to slide number 3, just a little bit of an overview on this presentation. First, I want to make the point that this is an acquisition that is or a transaction that's really within Telix's sweet spot. It relates to a radioactive antibody drug. It's an area that Telix has a uniquely advanced and capable team. And so we really see this transaction as leveraging the core competencies of the company in a very additive way.
I'm going to be talking more about the technology in a second, but this relates to bringing on a new targeting asset that's relevant to the field of hematology with a lot of exciting applications. And as I said throughout the course of this presentation, I'm going to give you a bit more context on that. This is a fairly modest transaction consisting of approximately AUD33 1,000,000 in upfront payments, earn outs and then additionally royalties. And I will go through the details of the transaction in the second. Euros 10,200,000 or 16,500,000 of that is upfront, mostly in the form of a script based deal.
There's €200,000 €200,000, sorry, of consideration, which is really in order to execute some agreements regarding access to clinical data, but mostly this is a cash preserving transaction from the Telix perspective. This is a true Theranostic product. So there is a diagnostic product, which is actually an approved product in Europe. It's a very modestly selling. It does a few €1,000,000 in sales a year because it's a very niche product, but we see the opportunity to considerably expand the indication of that product and that's part of the business case for taking this asset on.
And then a very exciting therapeutic landscape, which we think is a very nice augmentation of Telix's existing therapeutic focus areas. Just by background, moving on to Slide 4, FerraPharm, just a bit of background on the company. This is a Swiss German company, a headquarters in Zug in Switzerland. It was founded by an ex Roche executive and a colleague Silke Thompson, so it's Klaus and Silke Thompson, you can see a short biography there on the slide, really in the last 5 years has been developing this technology for some of the application areas that we're going to talk about in this presentation today. The technology originates from Beringwerke, which for those of you who know a bit of pharma history is a very fertile innovation has a very fertile history of innovation.
The imaging rights to the technology have been licensed to Curium Pharma. Curium is a company that Gilex already has an existing relationship with and these rights are mostly around the European rights. So, Telix will be certainly looking at developing these assets in other or making this asset available in other territories as well. And of course, the key driver for this transaction is the therapeutic applications, which I'll go into in a second. So that's just a little bit of background on the company.
Moving to the next slide, Slide 5. So this is really your science lesson for the morning, but it really highlights why this is strategically such an interesting transaction. So the last couple of scans that you can see there will be very familiar to you. These are gallium PSMA or prostate cancer imaging scans, which reflects the state of the art of the technology that Telix currently commercializing. And for those of you who are newer shareholders or newer interest in the company, we have filed U.
S. And European marketing authorization for this product and expect to commercialize next year. And the purpose of these images is to image cancer cells that express a specific target, which is called PSMA, prostate specific membrane antigen. And so when we see a hotspot, most of those little arrows are relating to clusters of cancer cells that are being imaged by basis of that cell surface signature. On the right hand side, this is a completely different thing.
This is imaging cells as well, but instead of imaging cancer cells, it's actually imaging immune cells. And so what these scans are really doing is they're imaging a map of your immune systems activity or to be accurate, a subset of your immune cells, where they are in the business where they are in your body and where they're localizing. Now those scans that you can see there, the 2 skeletal looking scans, those are really scans of bone marrow, the location of bone marrow and unsurprisingly, you're getting essentially a skeletal scan. But this technology is also capable of looking at the scenario where immune cells migrate and concentrate, for example, in response to an injury or an infection or an inflammatory process, as you can see from the example thereof of a patient with essentially a type of arthritis where you can see that there's an accumulation of inflammation in the feet. So here really novel concept.
This is about looking at imaging immune function and treating immune function rather than imaging a specific oncology target. But same principle, but a very expanded utility. So taking this concept ahead and moving into Slide 6, so just as Telix has been traditionally developing ferranostic products for oncology targets, so for imaging and delivering radiation on to oncology targets. The purpose of this transaction is to deliver imaging and therapeutic radiation to immunology targets, specifically a certain set of subclasses or subtypes of white blood cells or what we call leukocytes. And there are 3 types of leukocytes that express the target, which is called CD66 or cluster of differentiation 66.
The CD66 target is expressed in bone marrow plasma cells. So really the cells that essentially define your blood your bone marrow. Neutrophils, which are the white blood cells that flock to the site of an injury or an infection or an inflammatory process. And then the third one, which is also really interesting is that there are lymphocytes that live inside the tumor microenvironment. They're called tumor infiltrating lymphocytes.
And they are essentially part of they're increasingly understood to be part of the bad actors as we call them inside a cancer tumor microenvironment that essentially stops an effective immune response from attacking those cancer cells. So they're essentially an immunosuppressive species of cells that lives in the tumor microenvironment. So 3 very, very clinically and medically interesting targets, target cells to be able to image and then also to be able to deliver therapeutic radiation. And so you can see those arrows on the right hand side for the bone marrow. We want to essentially radiate bone marrow in many instances, and I'll talk more about that in a second.
This is a therapeutically important task to be able to do. For the second application, per the example on the previous slide where we're looking at a particular accumulation of immune cells, being able to image, that's what the DX stands for diagnostics, to be able to look at infection management and understand the trafficking of immune cells in immunology and rheumatology applications. It's very exciting. And then the 3rd application is potentially improving the efficacy of different types of immunotherapies by being able to target these bad actor cells that are living in the tumor microenvironment. So three very important applications, we're localizing this target CD66 is meaningful.
So moving on to the next slide, we are starting to build an articulation at Telix about really what the big picture vision is for the company in terms of the role of targeted radiation. And it's been clear from our commercial activity over the last couple of years that we have a very ambitious plan for making sure that diagnostic and therapeutic targeted radiation is a standardized part of cancer care. And so the historical areas that we focused on, obviously, diagnostic imaging is a cornerstone of what the company has been doing to date. We've announced a number of collaborations and partnerships recently around radiation oncology. So that's integrating molecularly targeted radiation with conventional external beam radiation in an additive way.
We increasingly see value of bringing imaging into the operating theater. So again, we've announced number of collaborations recently in technology acquisitions where we're looking at not only being able to do a whole body scan, but then being able to intraoperative guidance and you're going to see a lot more collaborations in that space over the coming months years. And then first, some of them fairly large clinical trials that we're either running or getting ready to run really the combination with medical oncology. So how do we maximize the standard of care in combining medical oncology with radiation oncology approaches. And so from the company's perspective, we really think that there's a missing puzzle piece there, which is if you think about a sort of a 4th pillar of therapeutic modality in treating modern cancer applications, one of those is really in cell and gene therapies.
And so this acquisition is essentially adding and completing the picture of what we think of as a kind of missing puzzle piece for where targeted radiation can play an important role. So I really want to make it clear, we're not changing the company's business model. We're not getting into cell therapies per se. What we're doing is we're looking at how to utilize radiation in a manner that is additive and beneficial to this increasingly important pillar of therapy, in not just oncology, but in some very exciting non oncology areas as well. Moving to Slide 8.
So this is a summary of the diagnostic product. So this is a Technetium-ninety 9 labeled product. It comes with a cold kit, very consistent product format to other Telix products. As I mentioned in the opening comments, it's an approved product in Europe and a handful of other countries currently distributed by Curium. It has a very narrow indication right now, which is really in bone infection.
But as we understand the utility of this technology more and more, it's clear that there's a whole variety of high value indications that we can expand and it's expand into and it should be obvious that once you have a product that's approved, expanding the utility of that product is a relatively straightforward activity. So we have plans over the next 2 years, both through company sponsored studies and also through investigator led studies to expand the data set to be able to, we think, significantly increase the range of indications that this technology can be used for. You don't need to be a medic to appreciate that some of those applications listed there are extremely large indications. So a lot of great potential for the use of this imaging agent. I think, again, to be able to do so with an approved product, at least the European approval, makes life relatively pleasant.
Moving to the next slide, Slide number 9. So just consistent with all of the Telix products that are under development, we have both the diagnostic and the therapeutic. The premise of this transaction is really driven by the therapeutic applications. The diagnostic is a nice to have and it's certainly going to be useful for patient selection and for looking at treatment response for some of the therapeutic applications, but it's the therapy applications themselves that are particularly interesting. So the TheraPharm team has been developing a yttrium labeled variant of their bezelizumab antibody and have been studying it primarily in this general application of bone marrow conditioning.
And essentially what bone marrow conditioning is, is that prior to giving a bone marrow transplant or specifically a bone marrow stem cell transplant, this can be an autologist transplant, I. E, originating from the patient themselves or it can be a donor matched transplant. And increasingly, there is an availability of donor matching for these types of stem cell transplant applications. Essentially, the goal is to eradicate the patient's existing bone marrow before effectively transplanting a new immune system. And I think this is essentially analogous to rebooting your immune system and in some cases, not just rebooting your immune system, but literally transplanting the immune system of another patient or of a donor that may not have some of the characteristics or some of the defects that are innate in a patient's bone marrow.
So this has utility and has been widely used in a variety of blood cancers or what we call hematologic cancers. But as I'm going to show you in a second, there's also tremendous utility in some very high value non cancer indications, which may pave the way to a fairly rapid product approval for this therapeutic indication. There have been a number of clinical studies run in Phase 1 and Phase 2 that show extremely nice safety and efficacy data. This is a well tolerated therapeutic. It has a broad orphan drug designation in Europe for bone marrow conditioning for hemopoietic stem cell transplants.
And so we think that with the orphan indication and the clinical experience in hand that there's a very fast approach to getting a first indication in a rare disease area called Sala, which I will elucidate further in a second. But once we've got an initial foothold in that indication, the ability to expand that therapeutic potential in an extremely broad fashion, And I'll give you the laundry list in a second of disease areas that could potentially benefit from this therapeutic approach. It's clear that this has got this is a platform technology that has a lot of opportunity to develop and evolve over time. And so just to be clear, we're acquiring this company, we're acquiring the Cerepharm assets in order to be able to build a long term development plan around anti CD66 targeting technology. And we think that this transaction gives us a very, very nice leg up in achieving that goal.
Slide number 10 just summarizes why this asset, this therapeutic asset is so important. So I've given you the high level sort of concept of why we do bone marrow conditioning or what we call BMC for stem cell transplants. The standard approach today is to use chemotherapeutic approaches principally revolving around a molecule called melphalan. It's a highly toxic drug. It has a very high or comparatively high patient morbidity and mortality rate.
Requires significant hospitalization, sometimes very acute hospitalization. In some countries, patients are in hospital for several weeks on an occupational basis. And really the cost of managing that acute care, that intensity of care is pretty significant. And so the value proposition really of this technology is it has the potential to be used in an outpatient basis, dramatically reduced hospitalization times. But most importantly, there's a whole swath of patients that are going to be able to get bone marrow conditioning that wouldn't have been eligible before, particularly older patients.
With some pretty clear thresholds in clinical practice, where if you're dealing with a patient over 60, very unlikely to receive this therapy. Patients that have impaired biological functions such as impaired renal function are not eligible for the standard approaches. The standard approaches carry a high risk and long term consequences in pediatric patients. So if we can come up with a better, safer, faster from a hospitalization perspective way of preparing patients for these stem cell transplants, we have the potential to really transform the utility of the field. And I mean to be clear, today and you can see from the graph there, this type of stem cell transplant is widely used in a variety of oncology and non oncology applications.
But we see the potential to really expand the field. If we can make a bone marrow stem cell transplant or hemopoietic stem cell transplant commonplace, safe and accessible to a very wide range of patients, then the utility of the approach in this field is going to expand considerably. Moving on to Slide 11, I don't think it would be reasonable to talk about a new technology acquisition without noting some competition. Clearly, the standard of care, which I've just sort of outlined is a well established standard of care. There's a lot of optimization that's happening in that standard of care field, new combinations with other chemotherapeutic agents to try to improve the therapeutic index and improve the risk benefit profile.
But generally speaking, we see that this is an area that's underinnovated, where there is the potential to come out with things which are much better tolerated and applicable to a much wider range of patients than the current standard of care approach. But it is worth noting from a competitive perspective that we're going to need to show the clinical trials that give clear evidence that we can displace the standard of care. There's 2 other companies, Actinium Pharmaceuticals and Magenta Therapeutics that are developing conceptually very similar products. We think that it's a good sign that there's other development activities happening in the space. There's a clear recognition that there's a need to improve the standard of care.
But we nonetheless take the view that the approach of the Therapharm team is highly differentiated and is likely to have a clearer commercial and clinical success profile than some of the competing solutions that are out in the space at the moment. Moving on to the next slide. So this is kind of an embarrassment of Rich's slide, but essentially it really illustrates that if you can make a HSCT procedure very commonplace, low risk and broadly applicable to the widest possible range of patients, there's a ton of diseases and serious conditions that would benefit from this. We like this asset because it's grounded very much in the oncology domain, which is something that Telix understands that we're building a good commercial footprint in. But you can see it also has the potential to expand into a whole lot of non oncology indications for, in some cases, some very high value rare diseases.
And I think most people know that if you can pursue a rare disease application, your path to market, your clinical trial burden, it can certainly be greatly accelerated. And so we see the potential in terms of the development strategy for this asset to first focus on a high value rare disease application with a good market size in its own right And then over the course of time then to expand with the clinical evidence into some very broad oncology and immunology and inflammatory applications as well. Moving on to the next slide, Slide 13. So I've mentioned Sala before. SALA sounds like it should be a brand of cracker or something, but it actually stands for systemic amyloid light chain amyloidosis, which sounds like an incredibly redundant sentence, but if you're a medical specialist in this field, it's a name indeed.
So this is essentially a rare disease with a very poor prognosis. And essentially what it is, is that your plasma cells or your leukocytes in your bone marrow, they basically don't express antibodies in the correct way. They spit out pieces of antibody that's misfolded and this forms an aggregate or a fibril, which in turn gets deposited into your major organs. And the net result of it is once you're diagnosed with it and this pathology is progressing, you have a very, very short period of time to intervene. It is an orphan drug.
Prevalence is 30,000, 40000 patients a year in the major markets. We see based on reasonable price benchmarks that this is around a US600 million dollars addressable market for the U. S. And EU5 across the size of this patient population. The current standard of care is pretty aggressive.
It's essentially to prepare for that stem cell transplant. But these patients are challenging because the deposition of that amyloid into the major organs means that a relatively small percentage of patients perhaps at most 20% or 30% are eligible for the type of standard conditioning regimens that are used. And so there's an absolute major unmet need to prepare these patients for stem cell transplant in a different way. And so we have a trial, I shouldn't say we, it's a Royal We, Therapharm team in collaboration with the University of Southampton has a study running called TRALA, which is just in the process of reading out. In fact, we're going to be expecting a data readout in the next couple of weeks.
But the purpose of this is to look at the atrium90, N036 MTR, the TheraPharm therapeutic asset as the sole conditioning regimen. In other words, there's no other preparation of the patient for a stem cell transplant than this therapeutic asset. So it will be really exciting in a couple of weeks' time to be able to present the top line data from that study. But you can see this is an example where we have a patient population in need of stem cell transplant to essentially to remedy the defect of their bone marrow, we can't use standard conditioning regimens because they're too toxic for those patients or for the majority of those patients. And so having a highly differentiated and innovative approach is a game changer in this patient population.
Okay. That's probably the end of the science. And hopefully that gives you a bit of context as to why we're so interested in this. To summarize, we intend to pursue the oncology and some of the bigger applications from a therapeutic perspective, but to start with a rare disease indication that can go extremely fast for which there's already a lot of key opinion leader engagement and certainly a vibrant dialogue with the regulators as well. And so we see a pathway to move very quickly in the development of the therapeutic asset.
And of course, the diagnostic asset being already approved in many countries, indication expansion is very rapid and tractable and cost effective. Moving on to Slide 14, so just to summarize the acquisition, the transaction details. So as I mentioned, there's an upfront component, mostly consisting of a script based acquisition based on the 10 day VWAP at completion, €10,000,000 there's this €200,000 cash payment, which is really to facilitate some data acquisition as part of the transaction. So just trying to make that a streamlined process in terms of moving ahead with the clinical data. There are 3 earn outs.
So there's a first earn out, which is a €5,000,000 payment upon successful completion of a Phase 3 pivotal trial for the 1st therapeutic indication only. There is a second earn out, which is based on the first approval, either in the U. S. Or EU, so that's first indication. And then there's a royalty of 5% on net sales for the 1st 3 years of therapeutic product sales for the U.
S. Or Europe. In terms of these sales for the 1st 3 years of therapeutic product sales for the U. S. Or Europe.
In terms of the script based component, I note that the founders, the principles of TheraPharm, shareholders of TheraPharm Fintech will have their shareholding subject to a 24 month escrow period. We expect the transaction to complete probably before the end of this week, but may take a couple of days extra. There's a bunch of administrative matters, particularly innovating some contract and commercial agreements that we wanted to trigger post completion and disclosure of the transaction rather than beforehand. So anyway, that's a summary of the acquisition. It's a modest acquisition.
It's back ended. It's cash preserving. And we think that it values the assets appropriately relative to their stage of development, but captures that risk adjusted upside for Helix shareholders in the near term. Moving to the next slide, a key slide in my opinion. This is the operational and budgetary aspect.
So I note that we're expecting the first clinical data from a trial to read out fully in the next couple of weeks. I've mentioned that the therapeutic modality has potential for a very fast track based approach. And so in terms of budgetary impact in 2021, we are expecting that this acquisition will add about AUS5 $1,000,000 in terms of operational development costs. It's well within our capital capacity for the company, both in terms of our current balance sheet, but also our revenue and earnings expectations for next year. So it's a modest incremental financial burden.
One thing we note is that we have an investment next year in our Cinesse site in Belgium, which we acquired earlier this year. That investment is leveraged very much by this activity. So the infrastructure and the build out and the planning that's going on at the Sinesse site will underpin this asset as it will the other Telix pipeline. So it's very, very synergistic. I note that the co founders of the Therapharm team, Silke and Klaus, will join Telix both in the commercial and program management activity.
We're certainly delighted to have a couple of stellar new team members join the business and help us to pave the way for a product approval for the therapeutic asset. And it's fair to say that over the last 3, 4 years, they've assembled an absolutely stellar Scientific Advisory Board, particularly Doctor. Kim Orchard at University of Southampton, somebody who has contributed a great deal intellectually to the development of these assets and we are certainly looking forward to inviting the Sarah Farm Scientific Advisory Board members to the Telix SAB in due course. So just to wrap up Slide number 16 before I hand it over for questions and comments. Just to summarize, we're really excited.
We've built a company over the last 5 years that has an enormous execution in clinical capacity. I'll remind some of our long term shareholders that when we went out and raised the first capital 3 years ago at roughly $0.18 a share, our goal is to build a nuclear medicine business that could consolidate the potential of this industry. And we've executed extremely well over the last 3 years as a public company and we believe that as we look to the 5 year anniversary on the 6th December of Tealix through both its private and public existence, We are looking over the horizon at where the next big opportunities are in nuclear medicine and this is certainly a really exciting one. This is a single asset that opens up a whole new range of indications and opportunities in oncology and transplant medicine and some exciting rare disease applications. We are picking up a diagnostic product that although today has very modest revenues, we see tremendous opportunity to expand the clinical utility.
It will require some collaboration and investment, but it's a very tractable problem. And we think that Telix is uniquely suited to executing that. The therapeutic product will go rapidly to a product approval with the right clinical data. And we're very confident that the Therapharm team has the intellectual property to secure that application for this asset. And really this acquisition clearly leverages investment in the infrastructure and particularly the manufacturing infrastructure in Europe that Tealix has developed.
And of course, as I've mentioned, we're delighted to note that the key team members will be joining Tealix as well. Anyway, that's a summary of the technical, financial and operational considerations behind this transaction. Again, we're really excited about the potential of this. And on that note, I will open it to the floor for questions and with analysts first.
Thank Your first question comes from Shane Story with Wilsons.
Good morning, Chris. Good morning, David. Perhaps you can start with the Y-ninety therapeutic asset, please. Do you feel so characterized enough to go into pivotal studies for any indication in the sort of medium term? And maybe some comments on what you've seen in terms of its safety with the target indications in mind?
Thanks.
Yes. Sure, Shane. Look, so one of the advantages is that the dose of the antibody that's used in the therapeutic application is essentially the same dose of the antibody that's used
So the
pharmacology is very well understood at that dosing range. And because we have the imaging, we know the biodistribution and targeting of the therapeutic asset extremely well. In fact, it's really an ultimate theranostic application in terms of being able to image the extent of the disease or image the extent of the bone marrow if it's a conditioning application, look at the dosimetry, deliver the dose and then look at the imaging of response. So we have safety data in around just under 90 patients in total across all of the trials that have been studied to date. We think it's a highly tolerated, good safety profile therapeutic modality.
And then in fact, it's really that tolerability and safety attribute that compels us to develop the asset in a rapid way. So I think, yes, we do have the data to support it. I think that the trial of top line data when it comes out will be highly instructive as to how we progress, but we'll certainly in the New Year early in the New Year be consulting again with the European regulators around the best pathway to take the asset forward based on the data that we have. And certainly, the fact that the antibody, the exact same antibody is approved and in use in another product, a diagnostic product, but nonetheless, a pharmacologically relevant application, I think, is very beneficial to expediting that. Certainly, the CMC package and the manufacturing package for the antibody is the same as the approved product dossier.
Thanks. Look, you've been pretty clear about the, I guess, the sequencing of the indications in terms of your R and D clinical development. But I guess if you had the 2 or 3 sort of top indications in mind, maybe if you could help us size the R and D investment that we should be thinking about, say, over the next 3 years, that would be really helpful. Thank you.
Well, I think the main challenge is to run a clinical trial where you can really justify a totally alternative conditioning regimen based on a non chemotherapeutic approach. I think one of the challenges that we always have in breaking a new technology into a new area is that Even if we look at the existing conditioning regimens, they're well understood. Their hospitalization and management of those patients whilst demanding is well understood. So you've got to go you've got to bring a new technology into a relatively refined understanding of how to manage patients today. So what we're excited about with the Sala application is it's clearly an area where the existing conditioning regimen is just not a fit.
And so if we can show in a monotherapeutic context a new conditioning strategy, which is it shows really clear efficacy in that patient population where conventional regimens don't work or aren't the best fit, then that really then opens the door for a broader utility once that first indication is approved. There's no clinical difference in conditioning a patient for myeloma or ALL or some other proliferative disorder, there's no difference in conditioning those patients. So once you have an approval and once you can demonstrate that that conditioning regimen works in one indication, it's fully applicable to all of the other potential utility for that therapeutic as well.
Your next question comes from Harshan D'Silva with CLSA.
Good morning, Chris. Thanks for taking my questions. Starting with the imaging agent, what's the plans there for that product? Are you looking to seek approval in the U. S?
If so, what's required?
Yes. So we do plan to have that consultation with the FDA. It's not clear to us at this point in time and certainly from a commercial modeling and a transaction valuation perspective, we don't assume the U. S. Market.
But that said, yes, we will absolutely be looking to expand the utility of the technology into other markets where it's not currently represented. The history of the asset in terms of how it was developed and how it got European approval is a little bit tortuous and we've got some work to do to put a package in front of the FDA to get them comfortable that this is something that should have a U. S.-based approval. So we certainly are going to do that. In the meanwhile, we've got a number of key opinion leaders identified, in fact, have identified us as much as we've identified them in the process of diligence in these assets that are ready to start to do clinical studies to expand the utility in some of these key areas.
And there's a growing interest in looking at the role of this target in a whole bunch of clinical applications from a diagnostic perspective. So there's no shortage of potential collaborators in Europe and beyond for us to look at that indication expense into the diagnostic asset.
Perfect. So thinking about that diagnostic asset, I guess, near term growth from that product is by label expansion as opposed to geographic expansion. Would that be right?
Yes. I think the priority is label expansion. It's very low cost for us to do, very accessible, a lot of sites already incorporating the asset into different protocols, off label protocols. So in some cases, we'll be looking at de novo studies, in some cases, we'll be collaboratively accessing data. But and that's very cost effective obviously to be able to leverage existing clinical experience.
There's some absolutely beautiful data sets out there regarding some of the indication that we're interested in. So that will be certainly the priority, but Telix's mission, of course, is to have products that are available on a global basis. And we think this concept is powerful enough that we should be able to offer the technology to patients in all the markets that we serve, not just selected markets.
Great. Perfect. And then moving on to 90 ybezolizumab in Sala. Can you just give us a bit of color on what the clinical trial might look like, obviously, pending regulatory discussions? How many patients would you look to recruit?
And would you also look to recruit patients in the U. S. As well as the
EU? So I think that's a priority and because of the regulatory status and the history of discussions with European regulators, it will be much faster to get the study up and running in Europe and certainly the supply chain and logistics and manufacturing package already has strong experience in Europe. So that will certainly that will be the priority. In terms of the size of the trial, look, we haven't had scientific advice yet on the trial design from European regulators because that will depend on the data readout from this first study. But pending that readout in early next year, we'll be getting in front of the European regulators with a proposed design.
Typically for these very rare disease applications, you're able to run a trial that's less than 100 patients and regulator based on a final statistical plan. These would not typically be a randomized trial. We're looking at patients that are not eligible for the existing conditioning regimens. So it's likely going to be a single arm monotherapy preconditioning to stem cell transplant with the primary endpoint being the proportion of patients that have successfully engrafted at a certain time point post procedure. Typically, it's a relatively short time point.
The trials for HSCT engraftment outcome don't typically have a very long observation period. It's usually within a few months. You have the primary endpoint. Of course, you're following up patients observationally for a longer period of time, but this does not have to be a long winded trial. This can be a very short, very compact, fast, small numbers of patients.
And we probably have today 12 to 15 sites, predominantly in Europe, but a few outside of Europe that are ready to participate in a study like that with good interest and good awareness of what the technology is potentially capable of doing for those patients.
Great. Just my final question. Just a big devil's advocate, Chris. Like you say, we can see a clear path to market this product on the market potentially as early as 1H23 with a relatively cheap trial. Why would TheraPharm give up this asset at this stage?
And also for what it appears to be a relatively small sum of money? Just thank devil's advocate here, Chris.
Well, I don't think it's a small sum of money. I mean, I think that if the earn out is successful, I think that the Sarah Farm team will do very well out of it. Developing radioactive antibodies is a really tough thing to do. It's very interdisciplinary. It requires a lot of different skill areas and it requires the ability to mobilize the supply chain and deliver that supply chain effectively.
The discussion with the TheraPharm team actually started in relation to Telix building happen to have a license. It's one of the few really impressive production licenses in Europe that could meet the needs of the TheraPharm team. So I think what happened was, if I could sort of characterize the history of the discussion, it really started as how can we work together to bring a product to market rather than Telix really making another asset acquisition. And I think the more that we delved into it, the more we realized that if Helix was going to become the go to market partner, and if we looked at the risk benefit to the company, and we were shouldering a lot of financial and infrastructure and upside for doing so. And that's essentially how we've ended up in this situation.
I can't tell you, Hassane, for every new asset or new indication that Telix might go after in the future because we obviously have the goal of expanding our pipeline over time. And I can't guarantee that there's a need for us to acquire every asset that we ever partner with. I mean, clearly in the past, that's been the case. I mean, we have lots of technology in the Telix portfolio that didn't come from acquisition, but from in licensing and partnering. But in this particular scenario, relative to the amount of investment and the potential return, we thought that an acquisition was the right economic model for the company.
Great. Thanks, Chris.
Thanks. Thanks, Ashwin.
Your next question comes from David Stanson with Jefferies.
Good morning and thanks for taking my question. Just following up on a previous question. I wonder if you could give us sort of details regarding the lower toxicity and greater tolerability of the Phase in the Phase II190 clinical trial compared to, say, the standard of care at present? Just give us some color around that. Thanks.
Yes. Look, yes, so the asset doesn't have the sort of chemotoxicity of the existing standard of care. So in terms of the side effect profile, in terms of the off target toxicity and think the real advantage of the antibody based approach is that the delivery of let's call it the delivery of toxicity is very selective. And because of the dose level, because of the nature of the antibody, the by distribution of the antibody and because of the localization of the target, the radiation is only delivered really to 2 organs. It's delivered to the bone marrow and it's delivered to the spleen.
The spleen is a very radiation hardy organ. We don't generally worry too much about the spleen and the dose that's delivered to the spleen is well within critical organ safety limits. But the fact that you can deliver a fairly substantial dose of radiation in such a localized way means that the toxicity profile and the AE profile is really limited to very mild clinical events. Typical side effect profile for radiation, fatigue, perhaps a little nausea, but not any of the critical toxicities that you see with a chemotherapeutic approach. So I guess to summarize, David, the fact that we're using an antibody directed radiation like this in such a selective way means that we don't have to deal with these general toxicities of chemotherapeutic approaches and that's a really important deal.
You'll see from the scans that I even showed you before where you see a perfect skeletal image, you're not even getting a major clearance organ dose. Essentially, when you inject this thing, it just gets absorbed like a sponge directly into the bone marrow. As I said, a tiny little bit of splenic signal, but no meaningful liver or kidney signal. And typically, that's where the toxicity comes in is through your clearance organs. There's effectively negligible clearance organ irradiation because of the way that this thing behaves in the body.
Understood. And I know that you've got orphan drug designation in Sala for this product or the 190 product. Can you outline which other companies have orphan drug different orphan drug designations in SALA? Are there any that you're aware of?
Actually, our orphan drug designation is much broader than that. So the orphan drug designation is actually for bone marrow conditioning for HSCT. So the orphan drug designation is far it's a superset of the indication for Salla, not the specific for Salla.
Great. Thank
you. So if we so choose to and if the results of the trial study are what we hope they'll be, then we can obviously you can apply for a more specific orphan indication to facilitate regulator discussions. But the current orphan drug designation does encompass the solid indication as well as frankly, all of that laundry list of other potential application areas that I presented during the deck.
All on that basis and as a follow-up, is it fair to say that Actinium and Magenta also have orphan drug designation in bone marrow transplant?
It would be fair to assume that, yes.
Okay. Great. And then my questions have been already asked by my colleagues. I guess just changing topics completely, can you give us on this public call sort of an update on the start of your Prostact Phase 3 trial? Are we still thinking the end of this year or is it sort of moved given COVID?
No, we're still operationalizing. As soon as we have the minutes back, the definitive minutes back from the FDA, we'll put out a really comprehensive update, shouldn't be more than a week or so. It just takes a bit of time to finalize the meeting minutes that we can rely on from a guidance perspective. And so as soon as that's available, we'll be putting out a detailed update on prospect plans. You won't have to wait too much longer, David.
Thank God. Stay well. Thanks a lot. Bye bye.
Thanks. Thank you.
Your next question comes from Dennis Huang with Taylor Collison.
Good morning, Chris and David. Just on the trial trial, can you talk about the endpoints we'll be reading out? What information we'll learn from that trial?
Yes, certainly. In the deck actually, you can find a link to the clinicaltrials dot gov entry for it. It's footnoted on the SALA trial page. But the primary endpoint is looking at engraftment success in those patients. So it will be a therapeutic response outcome in those patients in terms of the overall effect of bone marrow conditioning as a monotherapy with this technology and then followed by evaluation of engraftment efficacy for HSET.
Okay.
Thanks very much. That's all for me.
Thanks, Dan.
Our next question comes from Michael Gergis with Blue Ocean Equities.
Good morning, gentlemen, and thank you for taking my questions. A few questions for me this morning. The first one of which is regarding yttrium manufacture. And I'm just thinking of the sort of the cost and supply equation there. I'm just wondering if you can perhaps provide some color on the availability of, I believe, it's derived from Strontium and the yield that you get out of that, please?
So we don't have a global supply chain concern with yttrium like we do with other isotopes. For example, other companies are out touting copper 67 and actinium225. These are isotopes that essentially have no established commercial supply chain globally. Yttrium is I think fair to think of it as a kind of an old world isotope. It was really one of the mainstay isotopes in nuclear medicine for a very, very long time.
It's actually an incredibly useful isotope and is widely used today, particularly in the cert applications. So for those of you that are familiar with CertX, you'll know that technology that Certosphere technology in most of its forms uses Yttrium 90. The global supply chain is well established. There are a number of significant commercial players that have effectively unlimited capacity. So getting access to YUTRIUM-ninety really easy, low cost, plenty of commercial options.
So we don't see the radiopharmaceutical supply chain, particularly as you're dealing with relatively small numbers of patients to meet some of the early indication potential, this is not a challenge for the product's commercialization.
Excellent. Great. And then, Chris, just I appreciate the trial of trial is waiting out in the near term. Just on the announcement there, there was reference to a Phase 2 trial with sort of already established efficacy and safety data. Can you just elaborate on what indication that was in, please?
Yes. So the data, as I said, the data right now, the asset has the YTRM-ninety asset has been explored in just under 90 patients, I think 85 or 87 patients. The primary focus was in hematologic oncology applications, so in myeloma and in ALL. But and to be clear, those are applications that we're certainly interested in going after. I think what's exciting about that data is the Y90 bezelizumab was used in conjunction with standard of care to establish whether it had incremental toxicity over standard of care.
That's something that's really important to establish. If you want to take a new bone marrow conditioning regimen into standard of care, you've got to benchmark it against standard of care. And so what we have is we have standalone safety and efficacy data as a monotherapy and we have cumulative safety and efficacy data as a combination therapy across that data set. But as I said, the majority of data to date has been in oncology, but we see the SALA approach as a way to really fast track a first approval that then could be expanded into all of those other areas.
Okay. Excellent. That makes good sense. And then just finally on just on the diagnostic front, for any sort of label expansions there in the European markets, is there a first right of refusal, for example, with Curium to distribute those products or perhaps as sort of larger markets open up, does it make more sense to have an in house team? What's your sort of thinking?
Curium is a private company. So I wouldn't comment on Curium's preferred business model. Look, we have a good working relationship with Curium. We see the potential to continue that working relationship in Europe. The diagnostic imaging product, we receive a royalty on sales.
It's a double digit royalty. It's potentially a business that we could expand a lot. But clearly, if we are going to take the investment risk in expanding the indications and I think some of you will understand Curium's business model, they are really not an innovator. They're a company that essentially takes the decline and takes it to market. Curium doesn't do a lot of clinical activity.
They don't invest in expanding the utility of the products in their portfolio in the way that a typical pharmaceutical company does. It's probably more effective to think of them as a sort of a CDMO. And so if we are going to take the initiative to expand the utility of that diagnostic technology, then we also need to see a return on investment to our shareholders for doing that. So I think that's as far as I'm willing to really discuss the Curium relationship at the moment. But as I said, it's a firm we have a high regard for.
We have close relationships between the management teams of the 2 companies and I'm sure we'll iron out those details as a function of the commercial opportunity.
Perfect. That's very detailed. Thanks a lot, Chris. Thanks very much.
Thanks, Michael.
Your next question comes from Brett Morgan who asks, can the PMSA and CD66 be done in one scan? As in, does the patient not have to have 2 sessions?
It's a really interesting question and really out of the box question, which I like a lot. I think I'm going to answer it in a selective way. I mean, generally speaking, we wouldn't do the 2 scans together. The PSMA scan, we do have a technician variant to that scan, which can be done on a spec system, the same as you would with a Technetium-ninety 9 bevelizumab or the Syntimmune product. If you were going to use the Gallium product, that would be done on a PET scanner and the Technetium product would be done on a spec scanner.
But interestingly, you could actually inject both into a patient and put them onto a spec scanner and get a dual image. It wouldn't be as nice as what you would see on a PET scanner, but you could certainly see the overlay of the 2. But I think where your question is getting, which is an interesting concept is for a long time, it's been believed that if we could find effective ways to reboot the immune system, that we'd be able to use the type of approach of a bone marrow transplant to really generally apply that approach in cancer. And there are indeed certain areas of oncology where that's a really standard concept. And the question is, and it's an open question, could we deliver that concept much more broadly into, for example, solid tumors like prostate cancer?
There's been quite a lot of work done in prostate cancer and breast cancer around using bone marrow transplants and donor stem cell transplants to really give that patient a new immune system, which can sit there and look at their disease kind of with a fresh set of biological eyes. So whilst it's a very speculative area, I think that there's a lot of research opportunity in looking at how do you more broadly bring HSCT and there's lots of companies that are developing CAR T therapies and different types of engineered stem cells where there's enormous potential to improve the efficacy of that whole field. And so I haven't talked so much about the broader utility of this technology, but what it all comes down to at the end of the day is when you give a patient a bone marrow transplant, it has to be safe. The conditioning process has to be safe. And at the moment, it's not safe or it is safe, but it has a highly burdensome toxicity profile.
And so if we can eliminate that and make a stem cell transplant a standard arsenal in cancer care with a low risk burden associated with the bone marrow conditioning, I think this whole field is just going to explode, not just on the oncology indications, but also in a bunch of autoimmune diseases, things like multiple sclerosis and Crohn's disease and obviously rheumatology applications that we've already even shown you some images for. So I think that we can make that process safe, then the field will really expand and the utility of those sort of cell therapies will really expand as well. So long winded answer, but I think it's an interesting area to explore from a topic perspective. I'll pause there because I could go on for a long time and I know people have got better things to do this morning.
Jenny Wang says, thanks for the presentation. Two questions. One, what's the addressable market for the diagnostic product? And 2, as SkinTEAM is in commercialization in EU, how much revenue is it generating at the moment?
So the revenue numbers, we wouldn't report Curium's numbers because they're confidential and they're and they're a privately held company, but I can say it's a few €1,000,000 in revenue. It's not a massive revenue generator today, but that's because the indication is extremely narrow and it's not and it's a sort of last resort indication from an imaging perspective. But we see a huge amount of clinical interest in expanding that. There's no reason why we can't increase the revenue for that asset by an order of magnitude or more if we establish right clinical relationships and particularly get our fingers on some of the key data sets that we sit out there that would support indication expansion. So we see it we see really as an upside.
I mean to be clear, the valuation and the objective of this exercise is really focused around the therapeutic programs, but the diagnostic programs are obviously an upside. And certainly, as we're building out sales force in Europe that's multi product capable, it's nice to have another product to be able to market.
Mark Sinatra says, in terms of time to market, where do the programs this transactions bring sit in Telix's pipeline? Do some move straight to the front of the queue, others middle, etcetera? And 2, are these the sorts of potential products you could build a sales team around?
So we don't see this transaction changing timelines for any existing assets. We'll staff and adjust to be able to develop these assets as a separate initiative. And I think our organizational structure and execution is fully capable of delivering that. As far as is this the types of applications that we'll go after, I mean, we certainly have an ongoing interest in building out our pipeline, but we want to send a message shareholders very clearly that this is not an infinite process. It's once we see a product go out the door, so for example, we are getting ready to commercially launch our prostate imaging program, the renal cancer imaging program is finishing Phase 3 trials.
As we see products go out the door from clinical development, we want to backfill that pipeline and to make sure that we are continuously at the forefront of where this whole field can potentially deliver. From a commercialization vantage point, certainly like our glioblastoma program, selling and marketing rare disease applications. It is a more compact market. It is clear who the customers are that you have to target. I mean, you're generally dealing with a lot of specialty centers, so it is almost more like a business to business model.
But selling a rare disease drug also has its unique attributes and there are certainly partners out there that we would consider favorably as potential commercialization partners if we get to the point where we have something to put out into the market. So I think good problem to have whether it's something that Telix prosecutes directly or does in partnership with a company that would have a proclivity for rare disease therapeutics.
There are no further questions at this time. I'll now hand back to Doctor. Barenbroek for closing remarks.
Well, thank you. We have gone quite a bit over the hour, but I appreciate your attendance and hopefully it was informative. Obviously, David Cade, Chief Business Officer and Head of Investor Relations and myself are available for follow-up if you have any further questions. And I thank you for your time and wish you a good day. Cheers.