Thank you for standing by, and welcome to the Telix Pharmaceuticals Limited Telix Results Update Call. All participants are in listen only mode. There will be a presentation followed by a question and answer session. I would now like to hand the conference over to Doctor. Christian Varenbroek, CEO.
Please go ahead.
Good morning, shareholders and colleagues. Thank you for joining us for this half year results call. Technically, Telix is a pre revenue clinical stage biopharma company, but with our anticipated first product approvals, this may very well be our last Slightly more informal results briefing. It's been a very commercially active year so far, and I'm looking forward to providing this update. I'll also note that I'm joining this call from our European offices, And it's frankly not the punchiest time of the day, so I hope you'll bear with me.
Moving past the disclaimer, which you can read in your own time and on to Slide 3 for those of you who are reading along This presentation lodged this morning. In many ways, this slide illustrates just how far the company has gone since our IPO in late 2017. It's an exciting time for the company because we are really starting to deliver at a commercial scale. There are very few peer companies in the radiopharma That has the level of clinical activity, business development and international reach that Telix does. The big push over the last 18 months has been to Kind of rev up our supply chain distribution network in preparation for the launch of our first product, ALUTIX for prostate cancer imaging.
Last quarter alone, we dosed well over 3,000 patients under compassionate use and special access programs in a multitude of countries. That's really operating Now at a commercial scale, behind the execution success is the strong command of the global radiopharma supply chain and our distribution networks in place, both for clinical activity and for product launch. Our manufacturing activity currently takes place in 11 countries alongside our own manufacturing footprint in Zennes, Belgium. The Telix team is spread out across 4 major global locations, Melbourne, Indianapolis, Liege and Kyoto in Japan. Our team has grown significantly over the last 12 months Despite pandemic operating conditions, our company is well recognized as a firm with a clear vision of where it's going and what it hopes to deliver for healthcare.
Next slide please. We've been fortunate enough to attract a number of new investors into the shareholder register alongside some valued long term relationship, So not everybody has an equal understanding of the science. So I'll spend a little bit of time summarizing what the company does and I always like to take a moment to explain the technology. In short, Felix is a therapeutic drug development company that specializes in developing pharmaceuticals that carry radioactive payloads to the site of the cancer. Radiation has always been an important part of cancer care, but unlike traditional methods, which essentially involve shooting high energy x-ray beams at a patient's Cancer from outside of the body, our approach is to tailor molecules that hit very specific targets or signatures that are present on the surface of cancer cells.
Those molecules then carry a radioactive payload that is able to destroy the cancer. These are systemic therapies that are delivered We buy an IV administration and they are differentiated from traditional radiation oncology because they're not only able to target that very large bulky disease, but also the smaller metastases that are not visible with clinical examination or imaging and therefore typically elusive to treatment. Although we're a therapeutics company, we have a strong commitment to diagnostic imaging. The reason is quite simply that medicine in 2021 and beyond is all about Decision and personalization to the individual patient and we want to make sure that we're delivering the right drug in the right amount to optimize therapy. The beauty of this technology is that the radiation we use when delivered in small amounts or using a diagnostic radionuclide enables one to put a patient into Scanner an image from their toes to their nose everywhere where the target is present or where the drug can actually be reached.
We then scale up the radioactivity using a more potent radionuclide and then we are able to treat the patient with the same level of specificity. We simply call it see it treat it. You can see some examples of our product candidates in action on this slide. Those images on the right part of the slide are actually of our patients with metastatic prostate cancer And those bright spots are the tumor seen throughout the body, either imaged or treated. I think that's sort of enough of a high level overview of the technology.
Moving on to Slide 5. This is a very busy slide and I'm not going to go too much into the pipeline line by line. This is more I have an overview slide to illustrate the breadth and depth of our pipeline. And I think there's some sort of key messages I'd like to get across. And the first one is that we are always committed Imaging and therapy for every target that we go after.
And imaging tends to lead the development because the trials are faster And the regulatory burden of clinical development is generally lower. The other thing is that we chose this portfolio because there are synergies between the different So for example, a product for renal cancer and a product for prostate cancer generally target the same sort of clinical stakeholder. And that's really important as we become a commercial stage company and we start to think about our selling strategy as a business. You'll see some signs of life cycle management in there. There are some follow on products on, for example, the prostate cancer imaging or the prostate cancer therapy, where we're developing new early stage programs that have a very different product profile.
And this is all really about maintaining that category leadership that we think is important to the future success of the business. We have some rare disease focus in cancer and in bone marrow conditioning for hemophoietic stem cell Plantation that follows our successful acquisition of Serafarm last year. Those programs are exciting because they have a relatively fast clinical development timeline and can be run with can be developed with fairly compact clinical trials. And then last of all, I think it's important to note that in many cases, these targets that we go after like PSMA, prostate Specific membrane antigen and carbonic anhydrase 9, they have utility in other cancers. And as you'll see at the end of the presentation, We're really actively expanding our clinical activity to explore the utility of our pipeline in other cancers.
Moving on to the next slide. This is a really busy slide again, but with a lot of activity in the radiopharma space, we think it's important to shareholders about why supply chain matters and what isotopes are involved in leading the charge in Theranostic Medicine. Broadly speaking, there are 2 approaches to delivering a radiopharmaceutical. 1, our network approaches, because you're working with short half life radiopharmaceuticals. This is epitomized by very common products like FDG, fluorodeoxyglucose and Technetium based products, but we also deploy this method with gallium based products, for example, our lead product, ILUVIXX.
The other strategy is to do centralized manufacturing. This is when you have longer half life isotopes Perhaps a couple of days, then that allows you to choose one manufacturing site and kind of distribute from that one location. So we employ both of these methods depending on what the product is. Most of the isotopes that Telix uses Have multiple manufacturers and supply chains that are supportive of commercial activity and this is something that we've invested A considerable amount of shareholder capital in over the last couple of years. The exception to this is probably our research around alpha emitters.
Actinium-two twenty five It's getting close to having better availability, but it's not quite there yet. 211 acetylene is another isotope we like, but Far from having a commercially available supply chain, but still these may very well be important therapeutic modalities in the future and so We have modest research programs to understand their potential utility. And then maybe just to wrap up, there are a number of isotopes such as COPR-sixty 4, which are Actually on the cusp of being a therapeutic isotope because of their admission profile is sort of on the edge, but they really are likely to stay in the research domain as useful Tools for discovery and translation. Copper in particular has an awkward half life of 13.7 hours And the product yield that means it falls into a sort of no man's land, neither able to be used for centralized manufacturing, but it's also So I think it's really important that investors understand the layout of the space and what products are likely to be viable and what products are likely to struggle to commercialization. For Telix's first product to market, ILUVIX for prostate cancer imaging, the product has a shelf life of just a few hours from manufacture.
That's why we use a large network of nuclear pharmacies To deliver product to the customer's doorstep. And if the production yield is efficient and production is simple and fast, which our product is, This is a very streamlined way to make products available to the customer and this is certainly a very strong advantage that we have over our competition and I'm going to talk more about that in a minute. TLX's second product which is just finishing clinical trials, TLX250 CDX for the imaging of renal cancer is essentially Products because it has a shelf life of several days. So, although we actually still use pharmacy networks to dispense and distribute doses, It's still predominantly a centralized manufacturing model. Okay.
So That's enough of your science lesson for the day. Moving on to Slide 7. I hope I haven't lost too many of you, but I'm going to move now to a few operational and financial matters. Moving on to Slide 8. This slide in a nutshell summarizes what this year is all about for Telix and it also reflects The areas of emphasis in this presentation, I'm not going to go through every single asset and every single clinical activity, but really focus on our prostate cancer and Prostate cancer and renal cancer programs, which are the most proximal to commercial activity and therefore significant value inflection points.
But in essence, these three activities are really going to unlock the value of our pipeline. By getting our first product to market, We demonstrate that as a company we have the machinery in place to get a drug approval and the ability to act and interact with regulators in a sophisticated fashion. And I'm not going to lie to you, the first drug approval is always the toughest. And I'm not going to necessarily suggest that we'll get over the line and style, but we'll get there. And that's a big development activity for the company.
The second is, TLX250 Zircon trial In demonstrating that we can get a 1st product approved, that then lends credibility that we'll get second and third products approved. And the fact that we have a number of drug candidates And then last of all, with the commencement of Prostax study and I'm going to talk a bit more about some of the developments and really exciting developments in the Prostax study in a couple of slides' time. By showing that we can complete complex multicenter global clinical trials lends credibility in a way that many small biotech Biotech companies can't, that we can actually complete a Phase III trial. And so I think what I'm trying to get across here is that the Completion of the first drug approval, completion of the Phase III trial and then commencement of a very significant Phase III trial. These activities are all entwined with each other.
We understand that and that's basically the reason why this year is such a critical year for the company. Moving on to the next slide, Slide 9. This slide provides a sort of a simple financial snapshot of the company compared to this time last year. One could well imagine that we don't have too many more reporting periods where our financial summary will be this straightforward. But to summarize, we are in a rapid growth phase where our expenditure is reflective of late stage product development and commercial launch.
I'll talk in a minute about our pre commercial revenue, which is modest But we have a healthy balance sheet and we have the resources to be able to transition to an earnings based growth phase. That's something that I really want to put out. We have the financial resources to get through the ILUVIXX product launch and the TLX250 CDX product launch. And so I think we're in very good shape for the foreseeable future. We have certainly continued to invest in R and D and product development and As evidenced by our increased phone rate, we think we've done this very efficiently.
We leveraged a great deal of partnership Activity, collaborative research and non dilutive funding to deliver shareholders and patients a very compelling and cost effective R and D program. So I I think overall the company from a financial perspective is tracking very much in the right direction. Moving into Slide 10. As I've talked about in the past, we do sell our production system or what we call cold kits for Ilucyx on a limited basis in some countries, either as an investigational product or under various compassionate use and special access allowances. Post approval, both the volume and the price point changes a great deal because our approval is based on delivering a dose, not a cold kit.
However, the value in this pre commercial activity is to build out the infrastructure and operational basis of a commercial stage company and it really helps us to get market ready. I mean, it's great that we make a little bit of money, but the main objective here is that it builds awareness of the company with our prospective customer base. And I think we've been Very successful at doing this. We're a very well known company in the field and our customers are eagerly awaiting our first and second Product approvals, because of the nature of this activity. Moving on to Slide 11.
So clearly the future of Telix is not just about research product and marginal sales from compassionate use programs, it's about selling an approved product in a commercially Important market or set of markets. And now I'm going to give you a bit more color on where we are at with ILUVIXX. By the way, many of you have asked why the name of the product changed to ILUVIXX. And I just want to explain that regulators have naming standards and conventions for drugs. And one of the principles of drug naming is that it cannot typically elucidate a mechanism of action.
So we used to call the product ILUMET, but this was viewed as too The product that we've settled on Alutex as a brand for our product launch, but it's the same product. So again, we started on drug product naming. It's kind of It's more of an art than a science, I think. Moving on to Slide 12. This slide has been used in several presentations over the last few months and not much has really changed.
These timelines remain the best estimate timelines for approval in the 17 countries we are currently pursuing for marketing authorization. It's certainly a busy time for the company with a lot of moving parts as we respond to the final feedback and information requests from the various regulators. I think the key message here is that we are in the zone as far as approvals go. And most, if not all of our approvals, should be forthcoming between now and the end of the year. So really an exciting time for our prospective customers who are really eagerly awaiting the approval of this product for their patients.
There's A lot of pent up demand for this product in the marketplace. I will note that this is just the first wave of countries we're also gearing up either directly or through partnerships to apply for The partnership with China Grand Pharma for PSMA imaging is progressing really well and we expect to have our first product approval consultation with the Chinese regulator in a few weeks' time. So folks on both sides have been working very hard to make that happen. Our Telix colleagues in Japan are also working very It's been a real thing of beauty to watch. So anyway, to summarize this slide, it all comes to a head for Aluvix in the next few months.
And I think It's a really exciting time for the company and obviously for shareholders as well. Moving on to Slide 13. Of course, in some countries, particularly in the U. S, we have competition. It's very well defined competition, but we feel very strongly that we have the right partnerships We go to market strategy that is not only highly differentiated and increasingly well understood by our customers, but also a very rapid rollout.
I think that's really key. At the time of our FDA approval, we're going to be able to deliver product to a significantly larger proportion of the U. S. Population than our competition and make considerably more money doing so. We call it internally the Gallium Wave and it calls out the strength of the nuclear pharmacy approach And our key partnerships with Cardinal Health and Pharma Logic.
And I'd say both firms have been absolutely excellent to work with over the last year as we prepare for this product launch. Moving on to Slide 14. In terms of sales and market access, we're in good shape. Our in house sales team has been recruited alongside our partner organizations and between us we have the largest urologic oncology imaging product sales force in the U. S.
With the medical and market access resources behind it to guarantee success. I was personally in the U. S. 3 weeks ago, Yes, 3 weeks ago now, actually being part of the last week of sales training. And I have to say, it's It's just a joy to see such a passionate and revved up group of people.
As soon as we have our FDA approval, the HICS and pass through documentation will get filed at the next available entry date, and we have the necessary team in place to help our customers get on board with the product once approved. Our real strength in the market access piece is that our distribution partners already have established service contracts with most of the major markets and customers. So we just don't lose time negotiating contracts. We simply become another line item to an existing pre agreed set of commercial machinery. And this is something that our competition really doesn't have.
So we're looking forward to the most rapid product launch we can possibly achieve. Moving on to the next slide. I'm sort of a bit bored of presenting this slide, but just as a reminder to all that we're not shooting for a small commercial Here, prostate cancer imaging is the biggest new imaging opportunity in oncology for probably 20 years. It's a commercially significant opportunity that delivers A big unmet medical need and we're in a strong position to take a significant share of this opportunity. We also believe that our lifecycle management strategy in prostate cancer imaging, including a portfolio of really great second generation products will enable us to maintain category leadership in this space.
In a few slides, Tom, I'm going to talk about our renal cancer product well, as I mentioned, this is an important part of the strategy in terms of being able to follow on a second product into the GU Oncology franchise. In this respect, ILUTVIX is paving the way for product number 2 in a very efficient way and that's why we've made the investment we have in our sales force. It's a really exciting time to have that commercial machinery in place, which will ultimately support a second product as well. Moving on to Slide 16. I want to acknowledge that our product launch builds very much on the strength of our partners, Whether it's for generators, firms like Eiry and Eckerd and Ziegler, Cyclotron Technologies like GE, distribution partners in Europe, Asia and the Americas, It's taken a significant long term commitment with these firms to make our current achievements possible.
I often get called out From investor debt, Telix seems to have a never ending news flow of distribution announcements, but that's been a really important part of building the commercial machinery of the business. And these partners know that ALUTIX is just beginning as well. So we've invested in these relationships with an eye, both on this immediate product launch as well as future products coming to market. So we have a great set of business partners and I think it's An important part of the Telix story to share with you. Moving on to Slide 17.
Now I'm going I'm going to pivot away slightly from renal cancer into sorry, from prostate cancer into renal cancer. Move on to the next slide, please. So this is really the product that frankly Gets me out of bed some days or most days. I think that When we IPO ed the company, we didn't actually have a prostate cancer imaging product in the portfolio. That's because we felt there were a number of initiatives that we could either buy or partner into to deliver the companion imaging to our therapeutics program.
And that turned out to be the acquisition of ANGI in the late 2018. And I think it's a pretty stellar effort to have developed Salutex as quickly as we have. However, from an imaging perspective, the apple of my eye has kind of always been TLX250 CDX. This is an amazing product candidate that delivers Such an unmet medical need in terms of correctly staging patients with renal cancer. This has now been recognized by the FDA through the granting of breakthrough And so in essence, renal cancer is poorly staged.
And if we can correctly determine the extent of the disease, We have the ability to give patients a far better therapeutic intervention, whether it's smarter surgery or earlier detection of systemic disease where it may still We better able to be treated. From a commercial perspective, we have very little competition in this space. But as I said, this is an ideal follow on product for LUCIX because It's targeted essentially to the same customer base. We expect to commence the BLA consultation process with the FDA before year end. Moving on to Slide 19.
Just a short update on the Zircon Phase 3 trial. We've been fairly front footed about the fact that COVID has not helped this trial at all. We had an almost 9 month delay where we hardly recruited a patient and it was a bit like playing whack a mole with sites going up and down because of the pandemic. I'm pleased to say though that for our most recent update just a few weeks back, we are now well past the halfway mark and this trial is really accelerating nicely, particularly with U. S.
Sites starting to come on board and a few European sites returning to normal or sort of relative normal. It remains to be seen what impact the delta variant will have, but I don't think we're going to see the extreme shutdown condition to clinical trials that we saw last year. So I think And broadly speaking, we're moving into a clear space. We're on track to finish this trial by year end and then feed into a rolling CLA Biologics license application submission process. We built out a team quite a bit on the manufacturing biologic side And we're in good shape to move this product over the line and give our sales team a second product to sell in the fairly near term.
With the breakthrough designation, We are able to apply for a more accelerated review timeline. So as soon as zircon is done and we have top line readouts, this product is going to progress very quickly, subject of course to the trial outcome being successful, which I think we reasonably anticipate given the data that we have. Obviously, I can't provide you with guidance on how the trial is actually progressing from a data perspective, but our investigators are super excited about what they're seeing. The images are really beautiful and I'm personally looking forward to putting Zircon behind us and focusing on a second product launch. That will be a really important More on the commercial story around follow on products, especially our therapy products.
Although renal cancer is not as big an indication as prostate cancer, it's still a very significant market and the success That's the improved renal cancer treatments means that there's a significant reservoir of patients to manage like more than a 1000000 Americans We've seen multiple potential indications from incidental findings in surgical staging all the way to imaging metastatic disease and treatment So lots of shots on goal as far as this particular product goes. The target behind this product, Carbonican Hydrase 9, Also has tremendous potential utility in other cancers and you're starting to see some of this indication starting happening for other disease areas. I'll come back to that at the end, but it's a strategically important part of what Telix does at the moment. And the real advantage of this technology because we can use imaging to look at cancers and evaluate the potential for therapy at a very low cost and risk and then determine if it's worth expanding the therapeutic scope into those cancers. So the imaging gives us a really efficient process for indication expansion.
Slide 21. Now on to Prostect and TLX-five ninety one. So I think it's fair to say that with the completion of the Novartis Vision trial, The level of commercial interest in TLIX has really been at an all time high. The results of the trial, which by the way we were very pleased to support from an imaging perspective, validated that PSMA targeted in the TPM radiopharmaceuticals is a drug class absolutely worth pursuing from a clinical and commercial perspective. However, I'm also bound to note that the results of 4 months overall survival benefit were not so stellar that we can't jump over it.
And frankly, we feel that the vision trial outcome supports our strategy really more than ever. Moving on to Slide 22, please. We put out some exciting news flow this morning in tandem with our half year results regarding the expansion of the PROSTACT trial concept into really 3 studies. Obviously, the 2 additional studies are much more compact than the Phase 3 trial. But to summarize, We take a viewpoint that we're going to be in the process of developing 591 for A long period of time and we want to make sure that we have a commercial strategy that really covers different stages of the treatment journey for the patient.
So the Prostax Select trial, which is a relatively compact trial, it's going to be 30 to 50 patients. This is in early stage metastatic disease. The purpose of this study is to compare how a gallium based scan allows you to Select patients for therapeutic delivery. And this is a patient selection study that is going to be used at multiple points in the treatment journey. So this is really about Investing in a clinical trial that's going to allow us to do essentially indication expansion longer term.
And the second trial is a combination trial in the frontline setting with external beam radiation. This is a super innovative trial That has been generously co funded with Genasys Care. So we're investing in this trial together. This is a part of building on the Telix Genasys Care long term strategic relationship, which I have to say is really one of our most special relationships as a company. It's a very international relationship with a lot of different touch points, and it's With a lot of different touch points and it's great to be launching the study with the Genesis care team.
This will get us data on the use of radiopharmaceutical Targeting strategies in frontline prostate cancer care. And I think we can all agree that that has plenty of implications, Both from a patient management and a commercial perspective. And then the PROSTACT global trial, which is a Phase III trial. All of these studies are going to run-in tandem. So it's all about making sure that over the course of the next sort of 30 months that we have plenty of opportunities to read out data, Plenty of opportunities to provide new insights into how this drug works and what its benefit is to patients.
And I'll also note that We have a really rapidly growing level of pharma engagement around our pipeline, particularly 591 and 250, as evidenced by our most recent announcement that we are The clinical trials in combo studies with Merck. So I think this is a really exciting evolution of the Prostek program and as I said, it will generate lots of data. So I mean to summarize, we have a long term view of where we want to take TLX-five ninety one And broadening out Prostac will not only help us to achieve this, but also continue to deliver data and commercial visibility while we conclude the Phase 3 trial. So exciting times ahead for these assets. Moving on Slide 23.
We are increasingly asked about why our approach is differentiated and I thought it would be worthwhile spending a few minutes explaining why 591 is such an exciting drug candidate in prostate cancer. And so although we deliver Lutetium the same as the Novartis product does and we hit the same target Prostate specific membrane antigen, our mechanism of action is really different. An antibody behaves in the body extremely differently than a small molecule does. And I think there are 4 major areas of differentiation. The first one is, we believe and we have to demonstrate it, of course, now in a controlled trial setting, but we believe we can deliver Overall survival benefit and that's because we much more efficiently deliver radiation into the tumor.
We typically For given injected amount of radiation, we deliver 4 to 5 times as much radiation as the tumor. And the beauty of that is it means we actually need to inject less radiation as Patients, but we also get more therapeutic efficacy. So I think efficacy is going to be a big part of Prostact and the ancillary trials around it. And we feel confident that we're going to be able to demonstrate a significantly better overall survival. As I said, we need to demonstrate that in our Phase 3 trial.
Patient comfort, there are a lot of side effects associated with the small molecules. They range in severity, but they can be severe, including dry eye, xerostomia, which is dry mouth and back pain from having a ganglia, which are small nerve bundles, irradiated by Lutetium. We do have some toxicity in our product. We have some hematologic toxicity, but this is not a patient centric side effect. This is a clinical side effect.
Patients don't go home and complain to their partner about their neutropenia. So our side effect profile is very well understood. It's transient Predictable and frankly it pales in comparison to the majority of medical interventions for metastatic disease. So I think patient comfort is actually something that we really feel strongly we're going to be able to deliver to patients based on the 200 patients that we treated so far. The third one is a very patient centric regimen.
So One of the exciting things about our product is we believe that we can deliver a superior efficacy with a very short treatment window, Two injections, 14 days apart, and that's the end of the therapy. That's compared with 4 to 8 A forward fix injection 6 to 8 weeks apart of competing strategies. And what this really does is it ensures that Our product is a tool that the medical oncologists can use. Medical oncologists, I think rightly so, particularly for a metastatic They want to maintain ownership of that patient. Those patients will continue to take other medications.
And what we do is we allow the patient Have a very short detour for medical oncology, get their treatment, come back to medical oncology and retain control by medical oncology. That is both from a patient benefit and a commercial perspective incredibly important. And we've seen products fail in the past because of a lack of understanding of the importance of that dynamic. And then last of all, cost effectiveness, because we inject between a 5th and a 7th of the amount of Lutetium, We inject less radiation into patients. That's important in its own right, but there's less waste.
And this will have a very big impact on the cost Good. And TCEAM is still a relatively expensive component of a product. So all in all, between efficacy, patient comforts, the treatment regimen And the cost of goods, we have a real advantage we feel over our competition. And the next step is just to demonstrate that clinical utility in the PROSECT trial setting. Moving to the next slide, please.
So again to sort of illustrate why the imaging part of what we do is so important and fundamental to drug development in the This is just an illustrated side by side comparison between 591 and a therapeutic small molecule. You can actually see from the imaging what many of the off target effects So the key message in this slide is that we've chosen a strategy that we think delivers the best diagnostic pair PSMA prostate cancer. We feel that a small molecule like Ilucyx is ideal for imaging, rapid targeting, rapid clearing. The antibody is really ideal for therapy as it spares the endogenous PSMA expression and delivers a huge amount of radiation to the tumor in a very specific way. And this is why we expect ultimately that our product combination will deliver significant benefits to patients.
Okay. Moving on to Slide 25. Just as we have a lifecycle management strategy for prostate cancer imaging to maintain our category leadership, too do we have a similar strategy for therapy. So additionally, not all prostate cancer can and should be treated the same. Beta emitters have a fairly large radiation profile, generally understood as better for treating the bulky disease and the bony metastases typically seen in late stage patients.
But for very early stage patients that have a very modest amount of disease, an alpha emitter may be a better approach, Notwithstanding my earlier comments that isotopes like Acinium have a nascent supply chain. We've just started clinical trials of our 2nd generation prostate cancer targeting AT and TELIX-five ninety two. The so called QUPID Study has dosed for its patients and will really provide us with a great deal of information about one of our key platform technologies, which we call Radmab radiation antibodies. This is a way to very specifically reengineer just about any antibody into a targeting agent that's optimized for radiopharmaceutical use and particularly for alpha emitters. TLX-five ninety two is our 1st in house developed drug candidate as opposed to in licensing or acquisition.
And if it delivers what we think it will, It's going to really open up our pipeline for new targets and opportunities in the future. So I think from a scientific perspective, TLX-five ninety two is really one of our most Moving on to the next slide please. So just to wrap up on our prostate cancer therapy strategy, I'm getting very close to the end of this presentation. This is a variant of a commonly used graphical representation of the prostate cancer treatment journey, a sort of nomogram of disease progressions and treatment options as they The good news is that for a patient diagnosed today with metastatic prostate cancer, that patient is going to have a median survival of about 80 months, which is a decently long period of time. That said, we do think there's a lot we can do both with the imaging and the therapy in tandem Product and clinical activity under this clinical trajectory really illustrates that we have a comprehensive strategy for prostate cancer.
So from left to right, you can see where all of the different Prostact study components fit in From frontline therapy all the way to advanced metastatic disease, you see that we had imaging throughout the disease continuum from Pre prostatectomy or pre initial intervention all the way out to imaging metastatic disease. And we have 2 candidates for that newest term ILUVIXX and then 2nd of all, our Technetium based product, which is truly designed for the kind of rest of world activity, you can see the Cupid trial sitting there, that's kind of bookending. We are setting that both in late stage disease where patients are no longer responding to the TCM as well as, as I mentioned before, the earlier stage disease setting. And then because our biology of 591 is so different than small molecules, we have growing biological data that demonstrates we can treat patients that are no longer responding to competitive products. So whilst that's not the most commercially exciting market, it's still important for us to be able to provide new options for patients.
So, I think what you should be taking away from this is that we have a strategy, a clinical strategy and a commercial strategy That really enables us to support the patient every step of the way from the first diagnosis of prostate cancer all the way out to the end of life. That's a very ambitious vision, but we think that in order for this technology to really serve its purpose, that's the development And again, our clinical strategy is going to yield plenty of data and things to talk about over the coming months and years. So I think It's a very worthwhile strategy from a physician engagement perspective. Okay. Slide 27.
So finally, I'd like to wrap up and take a step back and give you a bigger picture. The goal of Telix was always to be a category leader in nuclear medicine. And although we have a big pipeline, we're actually focused around a relatively small number of targets Synergies between different elements of the portfolio and this very much factored into our execution plan. This graphic summarizes all of our current clinical activity. We have a pretty large number of additional investigator led studies around Ilucyx that are not listed here because we're not directly contributing resources to those studies.
However, I think it's illustrated to see how we have expanded our exploration of the utility of our pipeline. And there's a compelling clinical basis for each of these studies. I think it's very rare for a company of our stage of development to have such an outstanding clinical program. And I really have to credit Colin Hayward, our Chief Medical Officer and stellar team for the amazing progress in the year or so that he's been with the company and it's been a game changer. Obviously, I could go into each one of these studies in detail.
Most of them you can find on the various trial registry sites like clinicaltrials.gov and udra CT. I think the key message here is that we are maximizing the value of our assets in a very efficient and cost effective way with leading cancer researchers around the globe that Share our passion for nuclear medicine. And I'm just excited to see how some of this data pans out over the next 12 months. I think For almost every disease indication that we have on this slide, we will have data within a 12 month period, both therapeutic and diagnostic. Okay.
Slide 30, please. To summarize, every year since our IPO, Telix has grown and delivered We've become a very patient centric company with a team that is increasingly well positioned to deliver On complex global clinical trials and commercial product launch, we are certainly undergoing a transition at the moment, a very demanding one, but a very exciting one. Notwithstanding the sheer scope of our activity from the previous slide and that doesn't perhaps even reflect some of our preclinical and early research activities, which We are planning to say for a Science Day that we are going to put in place once the ILUVIXX approvals are out of the way. I'd like to wrap up just with this slide To reaffirm that notwithstanding the activity that we have, this is also a time of focus for the company. We know where the value inflection points are and I wish to assure you that we have our eye on the ball.
The next 6 months are going to be extremely interesting for the company, probably the most important If I'm honest with you, I'd probably say that every year, but this year is really key with our first product launch. Not many small biopharma companies get to the point of selling a product, particularly on the AFX. And so it's a unique time for us and frankly, we're energized by it. Thank you to our shareholders for your support and commitment. I always appreciate the reach outs and the feedback and encouragement.
It's great to see a growing number of overseas shareholders getting interest So that must mean we are doing something right. I'll now move the discussion to the floor for questions.
Thank you. Your first
So firstly, on the Alustix product, please, Chris. What FDA label do you expect for the Alustix product? Basically, is it do you think
it will be in line with your competition?
Yes, we expect that it will be in line with our competition. We haven't seen much evidence that The FDA wants to submit language. So we're expecting the label to include both the biochemical reoccurrence, so the 1st metastatic indication post prostatectomy and also the high risk men prior to prostatectomy. In other markets, We believe that we still have a possibility to get broader labels and we are I mentioned before that we have a bunch of investigator led studies that are collecting data in other parts of the disease continuum. And we certainly Have a very clear game plan to expand the label, but in the first instance, that will be the likely scope of our label and it's utterly consistent with competition.
Your next question comes from Shane Story with Wilsons. Please go ahead.
Thanks very much. Good morning, everyone. Chris, I'm going to start with ILUVIXX as well, please, and thanks for the clarity there on the regulatory timelines again. But I think many on the call would probably benefit from a blow by blow on how you expect market access to operate initially, Particularly for those U. S.
Centers who've been engaged with PSMA11 for some time now. And then maybe the timelines and mechanics of how the pass through coding process You mentioned in your remarks how that plays out. Thanks.
Yes. So I mean it's a pretty rigid process. There's not a lot of Speculation in that there's 4 entry points a year for CMS and for HCPCS and for Path to coding, they're all a little bit staggered. We expect to get into the next entry points before the end of the year, and that'll give us That's based on the standard timelines that we're seeing right now, which means that we'll have a full set of codes by So roughly the end of Q1, early Q2 of next year, depending on whether it's HICS, PICS or pass through. In terms of the market segmentation, I'd say a relatively small proportion of the market, maybe it's 15%, 20% of the market is going to be out of pocket.
The rest will fall into those 2 coding categories. That said, based on the existing experience that we have in the U. S. And the fact that there's a lot of sites that want to And running with PSMA-eleven, we don't see any shortage of potential sales in the near term, But ultimately, to really deliver the size of the market opportunity, those coding regimens are going to need to be in place. That's a fairly well understood process.
We have the documentation ready to go. The only thing that we need is The FDA license to be able to file that documentation. And I don't think there's a lot of speculation in it. To the extent that we can in advance And there are some compliance limitations there, but to the extent that we can, we are getting feedback How insurers feel about the product? There are a number of different parts of the market that determine how practice of medicine is reimbursed.
And clearly an important part of that is making sure that we are written into the guidelines that we have the support of the Society of Nuclear That there's evidence to ensure that there's medical support for This technology and what it can do for patients and again we're very actively pursuing that. So I think from a market access perspective including staffing it inside the company I think we're in
Your next question comes from Andrew Peng with CLSA. Please go ahead.
Yes. Hi. Thanks for taking my question. Just looking at the ILUVIXX rollout in the EU, so we saw the announcement on the decommissioning of the 1 of the 2 cyclotrons in Belgium, so that's going to be your manufacturing site. I just want to understand the volume of the kit that can be Produce there and will that cover all of the EU or will you require more manufacturing capacity?
And then also just a bit of understanding on the margin difference between EU and U. S. Based on your rollout?
Right. So first of all, synapse site, when we sell ILUVIXX, we sell in Europe, we sell the cold We are not selling finished radioactive doses. So the distribution model in Europe is very different. We get to work with We work very closely with some excellent distribution partners in various countries to actually distribute ILUVIXX as a production system. So the finesse the timelines on SYNephany, where our investment in SYNeph is really about bileutetium and The therapeutic programs and perhaps 250 CDX as well for zirconium.
So there's no correlation between what we're doing at And the launch of ILUVIXX in Europe, they're completely decoupled from each other. And then regarding price point, we haven't really given formal guidance Yes, on what the pricing of the kit will be in Europe, but it does vary between countries and it's certainly a lower price point than the U. S. We of course in our distribution contracts, we have pricing established, but we are not sort of focusing on pricing in advance of a product launch. But certainly once we have in all jurisdictions, once we have our approvals, we will start to move into a more formal forecasting process And then you'll have certainly clear visibility on price points and margins at that point in time.
Your next question comes from Dennis Hoang with Taylor Collison. Please go ahead.
Hi, good morning, Chris. Thanks for taking my question. I was wanting to swap over to the prospect group of studies. When I looked at trials.gov, Sorry, comparing Prostax Select to Prostax, it looked like they were targeting the same patient population. And I just wanted to check if that's the case?
And if so, how would recruitment in those two studies fit together? Would Postec Select come first or will they be recruiting In parallel?
They'll be recruiting in parallel and likely at different sites as well. The clinical objective of Prostac Select is really different than for the Phase 3 trial. It's really a big focus on the imaging. So and again, the idea of Prostax Select is to really very quickly get some information. So It's more likely to be an Australian centric study rather than a globally run study.
So whereas the focus for Prostact Global, as hence the name suggests, is really to build experience with the product in all the key commercial markets That we want to operate in it eventually when the product is approved. Does that make sense?
Your next question comes from Steve Wang with Jarden. Please go ahead.
Yes. Hi, Chris. Just a few questions on some of the more recent collaborations. So firstly, I'm interested in Genesis. Clearly, it provides you access to quite significant operations in Australia, Asia and recently the U.
S. I wonder if you could give any high level details around that collaboration, whether it gives you future access to clinics or Oncologists to help with future trial designs or distributional milestone payments. And then maybe we could talk about that well in the same vein.
Yes, yes, sure. So, well, so first of all, GenesisCare is it's been a relationship Over many years, we have multiple clinical activities with GenesisCare. No, we facilitate on occasion compassionate use access. It's one of our clinical relationships that we really prioritize as And it's a relationship that we value. Their acquisition of 21st Century Oncology in the U.
S. Makes Probably the world's largest outpatient radiation oncology or I would say more generally oncology network They have a lot of capability in that network. And they have a formidable market presence in the U. S. So we work with GenesisCare closely on a number of things.
We will certainly work with GenesisCare in a special way when we launch our products. And I think that, yes, it's a they're a very influential partner in the marketplace. They've got a large volume of patients to access. And I think as well, this unique thing about Genesis Care, which really is beneficial It's a highly innovative organization. So it's a sort of a sandbox where we both play together, where we can think about creative ways of deploying some of their technologies and capabilities and some of our technologies and capabilities for the benefits of patients.
I would say that we do use them as a CRO to some extent. They have a CRO business, which is growing. It's a high quality business. And that's something that we think is interesting in terms of leveraging their clinical network for trials. As far as the Prostact Target study goes, this trial has a materiality of a few 1,000,000 Dollars, we are cost sharing on the trial as part of an innovation cooperation, but there's no deeper Commercial entanglement in that other than the fact that we clearly want to prioritize using The Genesis Care Network for rolling out early product access in the future.
It's a great vehicle for us to get early access of products to patients. You asked about Merck. So We have a number of pharma collaborations, which are exciting. Merck is an example of that. Most pharma collaborations stay pretty quiet whilst they're in the preclinical phase.
And then when they go into clinical phase, obviously, it's not so straightforward Hi, anymore, because you obviously need to engage with patients. So we've had a roughly a 2 year collaboration with them. We've done some phenomenal science Together, I mean, the combination of low dose radiation and DNA damage repair inhibition is a really exciting concept. And The data that we have is exciting and of course it will get published. But in the meanwhile, we've agreed it's collaborated to move ahead with clinical trials And we're still mapping out the exact protocols and logistics around that, but we have filed signed a clinical trial collaboration agreement.
And I'm looking forward to seeing that preclinical research making it into patients in the near future. Hopefully that answers your question. Do you want to move on to the next question, if there is one?
Your next question is from David Stanton with Jefferies. Please go ahead.
Hey, good morning. Just a follow-up please. On TLX250 CDX, when Is your best guess that we might see that on the market in the U. S. Please?
Well, I think the trial will finish enrollment around the end of the year. And we've got about a 60 day period to get top line results. We have a pre BLA consultation with the agency plans. I saw that late November or early December, I can't remember which, but around that sort of timeline to start the discussion around the manufacturing package. One of the advantages that we get from The breakthrough designation is we're allowed to do a rolling BLA submission.
We are already getting ready to do our 1st commercial scale Production of the antibodies behind that program and we'll have that data to take to the FDA early in our consultation process. So The breakthrough designation allows us to apply for a priority review, which are prioritized review and accelerated review, which may mean that the agency can review a package in 6 months rather than 10 months. So if we were in a position to get our BLA Submission in place by say, April, March, April of next year, we could potentially have a second product approval by the end of next year. I have to admit, David, that's a little bit speculative at the moment because obviously until we get the zircon readout in place, it's all sort of continued on that. But assuming that we do get the trial readout done in the timeline that it's looking like, I think we're in good shape for a product To the moderator, if David's got another question, I'm happy to take it while he's there.
That's it. Thank you very much, Chris.
I mean, I think just as a general comment, I think the goal is to The sales of ILUVIXX will be in full swing by around the middle of next year. I mean that's where we really Expect that all markets will be fully active and there's a product launch kind of penetration time that's needed And what we see is attractive about 250 CDX is that once the sales force is in full swing and we're in full customer engagement, then We have another product really just over the horizon and I think that's really powerful from a selling dynamic perspective. So the way that the two products will layer on top of each other, It's going to bode well for the company. Okay. Is there any other questions?
I'm conscious that we're getting up to the end of the hour, so.
We do have one final set of questions from the web. We have Bob Williams at IV Matters asking, how will Telix manage 68 GA supply via Cardinal and ENZ in the U. S. When Ilucyx is released? And when does Telix think Ilucyx will be used for early stage PC versus late stage?
Right. Well, so in our label, we already have early stage Prostate cancer, so the label will include high risk men prior to prostatectomy. So that's really in a pre it's in a newly diagnosed high risk pre intervention setting. So that will be on the label from the very outset. There's a lot of chatter about Gallium 68 and not really quite Sure, where it comes from.
In 2018, we had a gallium supply shortage, but the industry has well and truly rectified that. Today, we have 110 sites out of Cardinal's 135 sites that are licensed and equipped and ready for Gallium 68. We have All the generators that we need to support commercial launch. In fact, we've just put in a pretty substantial order of generators. We do have cyclotron based gallium as well.
It's in our drug master file. This is a GE based target system or GE target system. There are some sites which are developing cyclotron based scallion, but we don't really rely on cyclotron based scallion To do product rollout, there's plenty of generators. Supply has boosted significantly in the last couple of years. We work very closely with all the generator manufacturers to make sure that there's supply available.
So This is really, yes, this is really not an inhibition at all to success categorically. So That's my answer to that question.
Perfect. That does This concludes our question and answer session. I'll now hand back
for closing remarks. Well, thank
you very much. I just want to express my appreciation to everyone for tuning in. Again, apologies. I'm probably not the fastest speaker this time of night. It's It's getting pretty late where I am.
It's almost 2 o'clock in the morning. But appreciate the opportunity to give you an update and feel free to reach out if you have any questions That weren't covered in the session. And thanks for your time. Have a great day. Thank you.
That does conclude our conference for today. Thank you for participating. You may now disconnect.