Thank you very much. Good morning, shareholders and colleagues. Welcome to the Telix Pharmaceuticals half year shareholder update call, and we appreciate your valuable time. As the company transitions from a pre-revenue stage company to a commercial stage company, we're also starting to evolve the way that we engage with shareholders in relation to results reporting, and I hope that you will find this update both useful and interesting. Moving past the standard disclaimer to the third slide. I'm not going to go through this in bullet point by bullet point detail, but over the last six months, our shareholder registry has changed a fair bit, and we have plenty of new shareholders. I'll take a few minutes to provide a short introduction to the company and what it does, focusing on a few specific highlights.
We are a late-stage pharmaceutical company developing radiopharmaceutical or molecularly targeted radiation products, as we like to call them. Our three disease focus areas are prostate cancer, renal or kidney cancer as it's more generally known, and glioblastoma, which is a type of aggressive brain cancer. We're going after a very significant market opportunity for our products, both in imaging and therapy, and I'm going to explain the technology basis of that in a minute. We're a very clinically active company, where we're currently running clinical trials in 25 countries around the world. We have just submitted our first marketing authorization for our lead product, which is in prostate imaging in Europe, and a U.S. FDA submission is very near to being final, and we're in the process of preparing for market launch, both in the U.S. and in Europe.
Also this year, we became a vertically integrated pharmaceutical company in Europe. We acquired a manufacturing facility in Belgium. That enables Telix to in-house produce all of our products for the European market, which is a very exciting opportunity. Finally, per the results that we released to market last night, we are in a strong financial position. We have a solid balance sheet and cash runway until late next year, sufficient to deliver on our first two commercial products, which is in prostate and kidney cancer imaging. Moving on to the next slide. The basis of the technology is very exciting. I'm not going to spend lots of time talking about the nitty-gritty details. Essentially, we deliver targeted radiation for oncology. We use a drug as a carrier.
It can be a small molecule or an antibody, and we use that drug to deliver a radioactive payload to the patient via systemic administration. What that means in lay terms is it's a shot in the arm. We are not placing radiation in a particular location in the body. This is an IV injection that whizzens the radiation around your body and wherever the target is present and wherever there's a piece of cancer, it targets the cancer. If the payload is a low dose or a diagnostic radionuclide, you get these beautiful images that you can see on the right, and we put the patient in a device called a positron emission tomography or a PET scanner, and that's how we generate those scans.
If you increase the dose or if you use a therapeutic radionuclide, you can treat the patient's disease in a very optimized way, clearly the imaging guides that therapeutic process. That's why we call it Molecularly Targeted Radiation. Although, it is colloquially known as theranostics. Radiation's an important part of cancer care, this approach makes it even more useful and effective. The next slide, please. This is we call the concept see and treat. I often get told by shareholders that our company is a little bit complicated, actually, it's pretty simple. Effectively, you put in a low dose of the drug you get an image. You put in a high dose of the same drug or a targeting agent that goes after the same target, you get a therapeutic effect.
This is a highly beneficial strategy because you do not just optimize the therapy, but you also streamline and de-risk clinical trials, and you ultimately improve the cost of clinical service because you are just treating patients that you know are going to respond to therapy. In fact, from the imaging, we can even predict to a significant extent what the patient response is going to be from the imaging. This is truly personalized or precision medicine at its finest. Moving on to the next slide. This is for your reference, but this is a high-level snapshot of our pipeline. I guess the main point here is that most of our assets are in late-stage development, and our two lead programs in prostate and kidney cancer are the furthest along with the imaging part of the pipeline ready for commercialization, particularly for the prostate cancer program.
Very exciting pipeline of assets in late-stage development, and significantly de-risked from a clinical perspective. Moving on to the nub of the presentation this morning, and moving on to slide number eight. This graphic sort of summarizes Telix's key focus areas to present. I'm going to talk about each one of them in this presentation, including at the end, a short update on what we've been doing on the R&D front, which is really exciting. We don't often talk about new product development because, to be fair, our investment in non-core assets was pretty modest, and we believe that shareholders expect us to be focusing our financial and corporate resources on our core pipeline.
As we get our first couple of products out to market, it's important that we have a game plan to backfill our product portfolio, we consider this to be a crucial part of maintaining our leadership in this space. By the way, that's something that's typically done late and poorly by small companies. We aim to be ready with a very good roadmap for second-generation products as our first generation of products starts to produce revenue. Moving on to the next slide. This is a synopsis of our key accomplishments in the first half of the year. It's been an incredibly busy first half. We're a December year-end company with a significant number of key accomplishments. As I mentioned before, we successfully submitted a European Marketing Authorisation for the prostate imaging agent, and with the U.S. application imminent.
We also had an excellent pre-phase III meeting with the FDA for our prostate therapy program. That's enabling us to finalize the protocol for that clinical trial, which will start before the end of the year. As I mentioned, we acquired a manufacturing site in Belgium. This is one of the deepest private nuclear licenses in Europe and really enables Telix to meet the commercial opportunity for its products over the next five years. We are in the process of completing a phase III trial, the ZIRCON trial, for our renal imaging agent. That included getting full recruitment up and running across all of our sites, although I'm going to talk later in the presentation about the impact of COVID on our clinical activity.
We are working on indication expansion for that asset, as well as noting that we recently achieved breakthrough designation from the FDA for that asset. That enables us to have a much more streamlined pathway to commercialization for that asset in the U.S. In the first half of the year, we announced several distribution agreements in Europe and the U.S. I guess the signal there to shareholders is that we're working extremely hard to build our production and distribution and sales and marketing capability as we go to product launch. That's a major focus area for the company right now. As I'll mention at the end, we've been active on R&D, including some non-dilutive funding, which is always good to see.
I think it's fair to say that we've been working to build out the bench strength of the company, particularly in our international operations. Overall, we did institute a hiring freeze during the pandemic or the first wave of the pandemic. Obviously, it's not over yet. We did still bring on some key recruitment in the commercial and the clinical areas to augment the team in a strategic way. Moving on to the next slide. We released our results last night, this, I suppose, is a snapshot of how we see the business and how we've financially evolved over the last six months. Clearly, our expenditure, and therefore our loss, has increased as we move our products into late-stage clinical trials and build out the operational bench strength of the company.
We believe that this growth in OpEx is commensurate and reasonable for a company of our stage, and we also believe that we are an efficient and frugal deployer of the capital that we have. We do continue to grow our revenues from early sales of the prostate imaging kit. Although this product is not yet approved, we have the ability to offer it commercially on a limited basis in some territories. Although it's worth noting that the adoption rate is a very small fraction of what would be expected of an approved product, and the same goes for the price point as well. Our improved cash from sales activity is partially a function of a generally improving commercial landscape, notwithstanding COVID-19, which again, I'll talk about in a minute. It's also partially reflective of better processes and systems for collecting receivables and managing debtors.
Again, that's part of the maturation process of the company. Over the last six months, we've dialed back external expenditure, which included program costs like clinical trials and drug product manufacturing, mostly in response to the pandemic. Again, I'll talk about this more later in the presentation. The point is that we've responded with alacrity to the changes over the last six months. We haven't dilly-dallied about waiting to see what happens. We've preserved our cash and been judicious in our expenditure, particularly around working capital costs. Moving on to the next slide. On the sales front, this slide illustrates the impact of COVID-19. We started the year off in a fairly strong way with the expectation that we'd see baseline of 350 to 400 kits a month and growing at 20%-30% a quarter from there.
Because our kits support multi-dose preparation, this equates to around 1,000 patients. Our expectation for 2020 was that we'd roughly hit the 18,000-20,000 patients level, up from 11,500 patients from last year. However, by March, it was already evident that non-critical oncology services were being dialed back, and this is particularly evident as we got into the worst part of the pandemic in European countries around the May timeline. The good news is that we're seeing good recovery and resumption of oncology service provision, including imaging. Our general perception at this time is that there's a degree of understanding that there's going to be multiple COVID-19 waves and that service provision can't stop. It's a changing landscape. The first experience of the pandemic incited a more extreme response, but we believe that in the future waves, that service will have a more normal operational profile.
Again, I want to stress that these are opportunistic sales from pre-approval product, and the pricing and commercial structure is not reflective of what we would achieve in a post-approval world. However, the value of this exercise is to start to build a customer base, and this activity has delivered Telix hundreds of customers around the world, typically large tertiary referral cancer centers that have an intimate understanding of the company and its products, thanks to this activity. This is a significant advantage when we achieve market launch next year. We have a customer base that knows us, understands our products, and is ready to use our products as an approved technology. Moving on to the next slide. This is a snapshot of our clinical activity. Currently, the company is very active on the clinical front.
I'm not going to go exhaustively through each trial. I do want to impress three things here. Firstly, although many of our investors view Telix as a diagnostic imaging company, we are in fact a therapeutics company predominantly that does diagnostics, and our most significant clinical activity is around our therapeutics programs. That's activity that will get a lot more spotlight over the next 12 months, clinically and commercially, particularly our prostate therapy program, which is probably Telix's highest value and most important program. Secondly, unlike many of our peer ASX or even overseas listed small cap biotech companies, Telix has a significant pipeline of clinical trials that are recruiting very large numbers of patients. These are typically not 10 patient trials designed to crank out a bit of news flow, but are often hundreds or more patients to generate Tier 1 evidence to support product approval.
Across our trials, we are amassing an astonishing amount of data and information about how to make this technology work. Not only are our clinical trials there to generate the necessary evidence to get product approval, but Telix is rapidly becoming the master of our domain in terms of fundamental understanding. Thirdly, our trials are truly global. Although we recruit for almost all of our trials in Australia, the majority of our clinical activity takes place overseas. We are currently active in about 25 countries around the world, not just to gain access to a diversity of patients, but to build the clinical and commercial visibility for the company for the future. Again, this is highly differentiating and means that when the time comes for our products to become commercial stage, we have the visibility that we need in the key markets that we serve.
Moving on to the next slide, please. Under the revised disclosure rules, we're required to provide detail in relation to the impact of COVID-19. I'm not going to do this on a line-by-line basis here. We've clearly had a lower pace of recruitment for clinical trials between March and July. We've seen essentially normal resumption of clinical activity in Europe. Australia, mainly because of border closure and access to drug product therefore being restricted, and the U.S. because of the really severe state of the pandemic, is still not at 100% normal operation. We dialed back our expenditure with a number of initiatives to maximize runway. We reallocated clinical and operational staff to other, more internally directed activity that's to the benefit of the company.
The net result is that notwithstanding the challenges of operating in a pandemic, we probably emerge from this first wave a stronger and more capable organization. I'm certainly very proud of all the women and men of Telix that have not slowed down in pursuit of the company's goals during this period, despite working from home challenges and juggling the work-life balance and families and the general stress of living through a pandemic. It's been a lot of work. Finally, unlike very large, vertically integrated pharmaceutical companies, Telix is dependent on many external service providers. This in turn means that their challenges and delays become our challenges and delays. It's meant a much higher degree of management of our service providers generally. A tough time on the company, but notwithstanding the delays and challenges of our operating environment, we've still continued to make a lot of progress.
Next slide, please. Perhaps our biggest unnoticed achievement this first half of the year was a European Marketing Authorization application, which was submitted back in April. This process is going very well and we're now engaging with each of the individual European member countries that we've submitted to, a total of 14 countries. The Danish Medicines Agency agreed to be our reference competent authority for the process, and we're now in, as I said, an individual competent authority review. We're expecting to get a consensus on our application late 2020 or early 2021. Generally speaking, the feedback and the questions that we're getting appear reasonable, and I think that's a well-managed process led by our Belgian team. We're also in discussions with several European healthcare authorities for temporary marketing authorization. Essentially a stopgap approval whilst the product gets its final approval.
Hopefully we'll be able to provide you with updates on that process between now and the end of the year as it will have a material impact on revenues. Moving to the next slide. Onto the U.S. front. We're painfully aware of the frustration and waiting that shareholders have had to endure with this process. Unlike the European submission, which was essentially able to get filed on the basis of a mostly complete package pre-pandemic, the U.S. application has taken a considerably longer period of time. This was due in part to COVID-19. I'd say maybe a three-month impact because of COVID, but also the Telix management team decided that on the basis of some new data, that we'd revisit the extent of the label for our submission to the FDA, and this has also added time to the process.
We're now on track to finish this package by the end of the month. That's the end of August, and then the e-publishing will take a couple of weeks thereafter. It's a pretty large package. It's not just uploading it to a website and hitting Return. I assure you that'll be done this quarter. In the meanwhile, we are working very closely with our market launch partners in the U.S. in getting sites ready to use our product. I should note that over the last two quarters, we've worked with almost 30 new clinical sites in the U.S. to get up and running with investigational access to our product, and we expect to add plenty of new customers between now and market launch in the first half of next year.
Assuming that the FDA is satisfied with our submission, it's going to be a really interesting time for the company in 2021. It's an extremely busy period for the company and we're ramping up the U.S. team in readiness for that. I have to say that our go-to-market partners in the U.S., both on the manufacturing and the distribution front, are doing a fantastic job too. There's a real commitment there to success for the whole initiative. Moving on to the next slide. I often get asked by shareholders about other jurisdictions, especially Australia, given that it's our home turf. I can confirm that we are in the process of preparing a TGA submission, which we expect to submit before the end of the year. Actually, there's an MSAC approval that's likely to happen in the middle of next year.
Aussie patients will definitely get serviced by our product, again, subject of course, to regulatory approvals. Similarly, we get regular Health Canada compassionate use requests. We service Canadian patients every week. We are currently preparing a submission package for Health Canada that will likely ride on the back of our FDA submission. We have a Swissmedic application in progress. I suppose if you look at the map of Europe, there's a big hole in the middle if you don't have Switzerland, but it's not just about the geographic aesthetics. Switzerland's a strategic jurisdiction for some countries that follow European or Swiss regulatory approval. We are in the process of dovetailing our European submission with a Swissmedic application. Finally, we don't often talk much about our commercial activity in Japan, mainly because it just takes a long time, and it's an extremely heavily regulated environment.
We've had good interactions with the PMDA, which is the Japanese FDA, and the Ministry of Health, Labour, and Welfare, which regulates a lot of the radiation safety aspects for establishing bridging clinical activity in Japan. We have Japan very much on our radar, and we expect early next year to be able to start getting this product into patients in Japan under clinical studies, with the goal then of bridging to the international approvals that we have in fairly short order. Yeah, really exciting, and just to give you a sort of sense of the breadth of what the company's currently involved in. Moving on to the next slide. I mentioned before, in my view, in the company's view, that the phase III prostate cancer therapy is our biggest program now moving forward. ZIRCON is under control.
The submission for the prostate imaging product is under control from a clinical and regulatory perspective. We're currently refining the clinical protocol based on the FDA feedback we received, which was particularly useful in understanding how we're going to use imaging to enrich the trial. One of Telix's differentiators is that for all of our programs, we have an imaging agent and a therapeutic, and if we can combine the two, we can generally develop trials which are much more streamlined, and much lower risk to execute. We're expecting to send a further package to the FDA in the next few weeks for an additional pre-IND meeting, and then that will enable us to finalize the protocol in Q4.
We expect to start recruiting, subject to regulatory approvals, start recruiting that trial before the end of the year or opening that trial before the end of the year, then with U.S. patients early next year. We're making great progress. It's a significant focus area for the company right now, and the team's doing a great job in moving this along. Next slide. Just to wrap up and summarize this, I hope it's evident that it's been an extremely busy couple of quarters for Telix. Notwithstanding that we're in the middle of a global pandemic, the team has accomplished a huge amount, and although not everything has been perfectly timed, the last six months have yielded pretty astonishing progress.
The second half of the year, just to remind, we are a December year-end company, is even busier as we ramp up to becoming a fully commercial stage company in 2020. It's an immensely exciting time to be a part of Telix, and I do want to reiterate that notwithstanding the challenges of COVID-19, we've carefully preserved our capital, we've adjusted our operating plans, and we have plenty of runway out until the end of next year if necessary with our current financial resources. The priority is to get some of these therapeutic trials up and running, but clearly the financial resources are going to be driven by our commercial launch for the prostate imaging product, in the first half of next year. Okay.
I'm gonna skip ahead now to slide number 20 for those of you who are reading at home from the deck that we loaded to the ASX this morning. This slide gives you a high-level perspective on how Telix tackles R&D. Essentially, we don't do basic R&D in-house. We prefer to build on top of the platforms that we already have. On occasion, we do in-license technology from third parties if we think it will augment our capabilities, and we certainly don't have a not invented here mentality. Because our first products are going to market, we're already thinking about the life cycle management aspects of our portfolio and maintaining what we like to think of internally as category leadership. We also have many opportunities to push our existing pipeline into new indications.
For example, TLX250 for renal cancer has potentially as much utility in ovarian or colorectal cancer as it does in kidney cancer. Of course, we have to do the studies to show that. The incremental cost of doing so is much less than, say, in licensing a new asset and developing a new molecule for a disease indication. We aspire to do both, but the point is that a big part of our R&D is about leveraging what we have. Moving to the next slide. This is a rather dense slide, and I apologize for the visually uninspiring nature of it, but it illustrates the point I've just made, how we've taken our core product and technology platform and expanded into new application areas. To do this, we work closely with really good academic centers and other companies as well to leverage their expertise and technology.
I'm going to go very quickly through these five examples. They're by no means an exhaustive summary, but show some of the key focal points of our R&D platform at the moment and some of the more exciting things that we are working on. The next slide, this is what we call TLX102. This product candidate builds on top of our experience with TLX101, which is currently in clinical trials for glioblastoma. It's essentially a new chemistry that swaps out iodine-131 with astatine, which is an alpha emitter. Alpha emitters are interesting because they have highly localized radiation profile. You can essentially target a very localized area.
It turns out that in multiple myeloma, which is a cancer that's evolved a lot in terms of treatment options, but still ultimately requires more durable therapies, it turns out that the target that we developed 101 for is also present in myeloma. The problem is that it's in the bone marrow, and what we want to do is we want to avoid irradiating the healthy bone marrow while we're treating the cancer cells. That's why alpha emitters are exciting. We've completed a lot of chemistry and preclinical development, including some extremely nice animal data, in what are considered to be industry-standard models of multiple myeloma progression. As a general rule of the company, we don't put out a lot of flashy ASX disclosures around preclinical studies. We prefer to wait until we have peer-reviewed publication.
Want to let you know that we are developing some really exciting science here, and we expect that in the second half of next year that we'll be able to start, obviously, financial resources permitting, we'll be able to start some first clinical activity for this asset. Really exciting extension of the company's existing core technology. The next slide. This is a pretty visually stunning technology, and rightly so, because the target is the surgeon. Moving on from multiple myeloma to surgery. I'm really excited about this research area. This program is part of Telix's life cycle management strategy for the lead product for the prostate imaging program. The commercial objective here is to deliver a second-generation product that not only gives you a PET scan, but also gives you intraoperative guidance with a fluorophore.
You inject the patient, you get your scan, and then for 72 hours after injection, you get fluorescence imaging in the operating theater. It turns out that robotic surgery or laparoscopic surgery is the big thing in prostate surgery. If we can show the surgeon where to go by lighting up in their field of view where the cancer is, this is something that's highly desirable. We've been licensed some technology as well as developed some in-house capabilities in this area. We're a few weeks away from seeing first patients getting injected with this dual modality tracer of optical and PET imaging. If that preliminary academic experience looks as promising in people as it does look in four-legged patients, we'll consider what our clinical development plan is for next year.
Really exciting example, again, leveraging our core technology platform for a future application area. Moving on to the next slide. This R&D program has the internal moniker, which is No Bro Left Behind, reflecting probably the youth and energy of our workforce, but I suppose the term bro doesn't project all that well in the public domain these days. Nonetheless, the goal of this technology is to make prostate cancer imaging available outside of the major markets that don't have PET. PET imaging, it's fairly expensive. It's not an institutionalized part of cancer care in many countries. We've got to have an alternative solution. It turns out that pretty much everywhere in the world has nuclear medicine, and they use a thing called a SPECT, single photon or a gamma camera for imaging nuclear medicine.
We have a variant of this product, essentially a variant of our lead product, that allows us to use an isotope called technetium-99 instead of gallium-68. What that does is it opens up the whole rest of the world for our products. Turns out that there's about 12 million men living with prostate cancer outside of the major markets that we can serve with our lead prostate imaging product. We'd like to take a portion of that, but more importantly, we'd like to make sure that imaging is available everywhere because imaging will drive therapy. This is an important lead-in product for delivering our prostate cancer therapeutic globally. We actually have a phase II trial. It's a registry study that's about to start called the NOBLE study. Nobody Left Behind is the acronym, so NOBLE.
This will start in a bunch of countries in the next month or two and is expected to complete before the end of the year. It's within our planned 2020 R&D expenditure, so this is not an incremental cost for the company right now. We are planning a phase III trial for this asset early next year. Again, part of life cycle management and category leadership in prostate imaging. Moving to the next slide. I'm not going to spend a lot of time on this one, but just wanted to illustrate, this is a snapshot of the NOBLE study, really illustrating how Telix is committed to making sure that we don't just deliver nuclear medicine to a few privileged countries but make it a global business.
You'll note the focus is on emerging markets, but we've also managed to include Australia, well, specifically Western Australia, which also has a need for this kind of technology in rural communities. I suppose I could make a joke about WA being a third world country, but we have too many Sandgropers as shareholders, so I'll refrain from doing that this morning. Moving on to the next slide. As TLX591, our prostate cancer therapeutic, goes into phase III trials, coming up behind is TLX592. The goal of this asset is to treat patients that are progressing off lutetium therapy. They will have had either the Telix therapeutic or perhaps the Novartis drug. They'll progress. It turns out that a significant subset of patients still progress and demonstrate reduced response to lutetium.
Some men will live out their remaining days with controlled metastatic disease and pass away from some other cause. 40% or 50% will need further disease management. The purpose of this asset is to address that progressing population, and I'm pleased to say that it starts clinical trials in a few weeks' time, which is really exciting. We'll be looking to get our first in-human experience with this asset and understand the pharmacology behind the asset and its suitability for this application. Again, this is a targeted alpha therapy product, so this is about providing highly localized radiation. We think that this asset has a lot of potential in treating those metastatic patients that are progressing off lutetium. Moving on to the final R&D slide. This one is really about indication expansion.
These really beautiful images, which are courtesy of our colleagues at GenesisCare, illustrate the potential of the TLX250 portfolio, both diagnostically and therapeutically in other cancers. These are obviously not renal cancer patients. Interestingly, this research very much came alive during COVID-19. When we paused our clinical trials, we still had to operate and maintain our manufacturing capabilities around the globe. Rather than throw an unused quality control dose down the drain, we made these doses available to our clinical researchers or to patients that needed compassionate use access because they couldn't participate in our trials. When we paused our clinical trials, we were very careful to make sure that we didn't leave anybody hanging. The result is that we are able to develop a picture of the utility of our assets in other indications beyond renal cancer.
It's immensely exciting and high-value clinical research, and it's very much an ongoing activity in the company. We now know that Telix's portfolio has applications in other areas, and this is very exciting and high value and incrementally very cost-effective research. Just to wrap up on the next slide. This is by no means an exhaustive activity list, but the purpose of this graphic is to illustrate to shareholders how strategic Telix is and how exciting our future is. As I said before, I often get told by shareholders, "Well, Telix is a very complicated business and there's a lot to understand" and that's true to some extent. It's also a really powerful business because it will almost uniquely integrate the practice of oncology in a bunch of very powerful ways.
We have on our radar four key parts of the oncology care continuum that we are able to deliver extremely important new capabilities to. By combining radiation with medical oncology, we're going to improve our therapeutic performance in sort of mid-stage cancer care, and that's reflected in the ProstACT phase iii and the STARLITE trials. We are combining internally directed radiation with MTR, with externally directed radiation from traditional radiation oncology, and we announced a collaboration with RefleXion just recently, which is a San Francisco, Bay Area-based company that's doing some highly innovative work in this space. Our clinical trials are also reflective of this. For example, the IPAX-1 phase I/II trial is a combination of internal and external beam radiation. I don't probably need to explain the diagnostic imaging part, but clearly that's our first commercial focus area for the company and is going to happen very quickly.
Just with the R&D updates, you can see that we're now taking the concepts of molecular imaging and patient staging directly into the operating theater. Going beyond just the pre-intervention image into image-guided surgery. This is a really unique position. For every single one of these oncology areas, we not only have to deal with those clinical stakeholders, but we also have to interact with the companies that are in the leadership position in those different fields. It creates lots of great opportunities for Telix to form partnerships and strategic alliances. This will certainly be evident as the year progresses. There's a lot of exciting stuff to talk about in the rest of the year and in the years ahead. Next slide, please.
We put this slide together really as a nod to our domestic Australian shareholders and taxpayers, frankly. We are fortunate to be the beneficiary of an AUD 11.4 million R&D tax credit this year, which is an astonishing amount of money. Frankly, it's the balance sheet of a lot of our peer companies on the ASX. Although we don't plan our runway on the basis of government funding, it's immensely useful money for building out our R&D and clinical capacity, including in Australia. We put this slide together to demonstrate our commitment to research activity in Australia alongside our global research activities, and that includes clinical and manufacturing partnerships. We're active in almost every major Australian city, we have a dozen collaborations with different universities and research institutions, and I'm pleased to say that we even manufacture drug products intended for global export from Australia.
A key message behind this graphic is that we are immensely fortunate that we have a very strong nuclear medicine and pharmaceutical development resource landscape in our own backyard, and we work with it extensively. We're very proud of this work, and it's great to have so much homegrown talent to tap into. Just to wrap up on the last slide in the R&D overview, I hope this has been interesting and useful, although very fast update and by no means exhaustive. I hope that I've gotten across the point that our R&D is about building on the core pipeline and technology strength that are already under development in the company.
Part of it's about new product and indication development, and it's partially about life cycle management. Some of our research projects are about building incremental value in our core pipeline, but a few R&D programs are also pretty cutting-edge, including some of the targeted alpha therapy that I've talked about before. This is a very big focus area for the pharmaceutical industry right now as they start to understand the impact of MTR technology in the mainstream pharmaceutical landscape. Just to wrap up. We have a lot of commercial and clinical workflow and activity over the next six months, but there are really five major events that will define the company between now and the end of the year. Clearly, the long-awaited for NDA submission, which is in the final stages of being done.
I suppose the analogy is we've just turned off the highway, and we're driving up the driveway, and you can see the lights in the house in the distance, and the front gate is open. That's where we're at. Just bear with us for a couple more weeks while we get that done. We believe that we have a very excellent package to submit and a strong clinical rationale for approval of that product. That's going to be a really key milestone for the company that we're excited about accomplishing, both for ourselves, for the team, and for shareholders. We are really focused on the market launch. This is consuming a lot of the resources of the company right now as we build the sales and marketing and customer service capabilities for Europe and the U.S., obviously in conjunction with our go-to-market partners.
It's a commensurate investment, but really designed to maximize the opportunity for our product launch. We're also really focused on getting the phase III trial for the therapeutic program. This is really designed to be a fast follower to the imaging, and to be able to offer a comprehensive theranostic solution in prostate cancer, which was the original vision of the company to begin with when we started the company. Tremendous amount of progress in the prostate area. We do expect to complete the ZIRCON phase III trial, complete enrollment for that trial around the end of Q1 of next year. Again, we've had delays because of COVID, but we're also scrambling to really pick that up. If we complete enrollment around the end of Q1, that means that we'll probably have a readout around the middle of next year.
Very pleasingly, we did get breakthrough designation for this product, which potentially shaves six months off the development timeline. Although we've lost time, we've also regained time, and we've previously disclosed to the market some of the benefits of that designation. Very exciting. The data that we're getting in the ZIRCON trial is extremely exciting, and the level of clinical engagement is really outstanding. Last of all, we don't talk about it a lot, but our brain cancer program is certainly very active. It is recruiting again. In fact, all of our European sites are recruiting into that trial, and we even picked up patients this week. That trial is alive and well, and I would imagine that before Christmas, we'll be able to provide a first formal update to the market on that program as well.
Personally, I find that it's one of our most exciting programs. It's just because it's early stage, it obviously has less investor focus. For the final slide 33, I'll leave this here as we transition to questions. We presented a variant of this slide at the start of the year, and I'm pleased to say that notwithstanding a few delays here and there, we're actually on track to achieve a very comprehensive set of accomplishments for our shareholders and, of course, our clinical partners and patients that are so important to the momentum that the company currently has. I think I've covered all of these topics in various forms, and I'll now open it up to questions from the webcast or submitted online from shareholders.
Your first question comes from Hashan De Silva with CLSA. Please go ahead.
Morning, Chris. Thank you for taking my questions. My first question, just on Illuccix. When we're thinking about the commercialization process of Illuccix, can you talk specifically of how you will get the dose to the patient given the half-life of gallium-68, as well as what the sales and marketing expense will likely increase as you launch the program?
In Europe, when we commercialize that product, we're really commercializing a kit, which means we're putting the kit directly into the hands of the hospital. Most of the production is done on-site. The presence of nuclear pharmacy networks like what we have in the U.S. is not the same. It's a very different model. We're shipping that consumable directly into the clinical environment in Europe, that's extremely straightforward. In the U.S., we are relying very heavily on nuclear pharmacy networks. About 90% of the delivery of Telix's products will be in the form of a final finished dose product. We work with Cardinal and PharmaLogic and perhaps in the future, other networks to fill specific geographic niches on a completely turnkey basis, where the dose is driven out from a nuclear pharmacy that's serving about a 90-minute driving radius.
The dose is ordered and made on the fly, and then delivered as an injection-ready dose, timed to deliver into a particular patient treatment window. We are expecting that by the time we're ready for market launch, we'll have over 100 nuclear pharmacies ready to do that across the U.S., covering probably 95% of the U.S. patient population. This is a real advantage of the gallium approach because we are compounding and delivering these doses under practice of pharmacy. That means it's a state-regulated process. It means that nuclear pharmacies can be ramped up and ramped down or reallocated in terms of their maximum cost-effectiveness.
This is compared to our competition, which has to use a cyclotron facility, which is clearly not a movable or a particularly flexible manufacturing approach. It means that we can really optimize our network for cost and transport to the end patient. We do expect that about 10% of doses delivered in the U.S. will be done via this sort of kit model like Europe, where we'll sell directly into tertiary referral cancer centers that have their own nuclear pharmacy capabilities. The vast majority of our doses will be delivered by our manufacturing and distribution partners.
That's the first part of your question. It's a bit of a complicated answer, but it's a big question, so I hope that answers it thoroughly. In terms of sales and marketing spend, we expect an ASP in the $4,000-$5,000 range for a dose, at least during the initial period of our sales. We expect that the SG&A component will be around the $500-$550 per dose. That'll give you a sense of what the investment on sales and marketing activity is going to be for the company.
Great. Just to build on that, I know investors from the ASX small cap biotech side have seen products launch into the U.S. and then demand eventually not being there and not being able to break even on that product. How is Illuccix different? How do you get confident around the demand side, given the expense that you've had to incur to get this product to where it is?
That's such a tricky question, Hashan. Basically, there is a standard of care. It's already approved, called Axumin. It has a well-understood sales profile. We have the clinical data that shows clear superiority. We've engaged extensively with payers on what they think the clinical evidence is behind the Illuccix asset. We're very confident that the adoption rate is going to be high. In other countries, in non-U.S. countries where we operate, we almost ubiquitously displace Axumin in terms of its clinical utility. Axumin has a relatively low level of insurer support in the United States, where we don't expect that to be the case for PSMA. I think that the clinical evidence that supports the use of the technology is extremely high.
There are going to be a relatively limited number of actors that are going to enjoy commercial success. I think that the commercial opportunity is very clear, and the partners that we have for doing ramp-up are excellent partners that have a dominant market share and the ability to get our product ubiquitously out to the U.S. market. To answer your question, part of it is the conviction we have around the product and the clinical data, and the fact that we don't have an approval yet, and we're already on a week-by-week basis dealing with customer requests. We have to, of course, field that very differently, and we have to deal cautiously with it because it's not an approved product.
We don't market a product yet because it's not an approved product in the United States. We work extremely closely with leading cancer centers to get investigational product use up and running or compassionate or magistral use, depending on the country. We ship routinely to more than 400 hospitals around the globe already. If we were to just activate our existing customer base with an approved product, it would be a very significant revenue stream to the company that would provide a very attractive return on investment.
Perfect. Just moving on now to TLX250-CDx. You mentioned that the ZIRCON trial top-line results are out middle of next year. When would you expect launch of that into the U.S. and Europe? Also on the breakthrough designation, how does that affect the commercial prospects of the drug, focused specifically on pricing?
It's a diagnostic imaging product, so the pricing is probably going to be fairly similar to the prostate imaging agent, which is already a premium product, at least during the passthrough period, which will be at least theoretically, we're in the process of finalizing that, but it'll probably be for the first three years. The breakthrough designation does make our engagement with the agency a little bit more streamlined, and it does enable us to do a rolling BLA submission. We're working on the premise that we'll have a post phase III meeting with the FDA shortly after we complete the rollout, complete the clinical trial, which will be in the first half of next year.
That may mean that if we do everything right and we're all on track from a manufacturing perspective, that we ought to be able to get a BLA submission in by the end of next year. The potential is there for us because of the breakthrough designation, the potential is there for us to get an accelerated review, and we have to obviously go through that process with the FDA. What it practically does is it gives us a much more streamlined pathway from completing the phase III trial to getting a product marketing authorization in the U.S. In Europe, we don't have that sort of a designation, so it's going to have to follow its own course of action. Certainly for the U.S., we have an accelerated pathway, potentially, if we can demonstrate the utility of the product.
Great. This is my final question on TLX592. There was a post at ASCO for a product that looks suspiciously similar to 592. If it is the same, the side effect profile looks significantly better than the 591. Would you potentially not progress 591 into phase III and look to go straight with 592?
No. The clinical data that we have for 591 is really excellent and fully supportive of a phase III trial. We have a lot of differentiation in that product in terms of what we expect the clinical performance of the product to be, use of the supply chain, and a lot of other aspects. We think 591 is really an excellent product that has a clear clinical pathway. The 592 product, your observations are correct. Dr. Bander, Cornell, and Dr. Tagawa took human J591, which is the antibody behind the TLX591 program, and radiolabeled it with actinium. Our view is that this is a very promising proof of concept. It really demonstrates the utility of our platform.
With 592, we've made some important modifications to the antibody that we think will even further improve its utility. You're absolutely right. It's an excellent clinical proof of concept. It's really promising. It showed that patients that are no longer responding to lutetium therapy, which we think will be a good 40%-50% of patients, can achieve further therapeutic benefit. Not only is 592 going to be life cycle management for 591, but it'll also become life cycle management for the Novartis product as well. That's clearly an interesting commercial opportunity for the company.
Perfect. Thank you for taking my questions.
Thanks very much. Appreciate your questions.
Your next question comes from Shane Storey with Wilsons. Please go ahead.
Morning team. Chris, maybe if we can go back to the TLX591-CDx in Europe, where you mentioned that the cold kit presentation would be the dominant format. Will you lean on the SHINE facility there to supply prepared patient doses within a sensible radius, given the half-life? As a follow-up, would you contemplate partnering with others to leverage other gallium availability further afield across Europe in terms of covering the continent? Thanks.
Definitely. Shane, if you get bored of being an analyst, we've got an operations role open in Europe, but you nailed it on the head. The SHINE site, there's two cyclotrons that will be upgraded at the SHINE site are capable of producing gallium-68, and we would imagine, not just small amounts of gallium-68, but really bucket loads of gallium-68. We announced a collaboration a few weeks back with ARTMS, which is a Canadian company that's developed ultra-high activity cyclotron production of gallium-68. We're investing in that technology partnership because we can probably service a good chunk of five decent European countries from the SHINE site, and plan to do so, obviously subject to a marketing authorization.
There are a few other markets where we do exactly what you said. In the U.K., we work with Curium and GenesisCare to do exactly that sort of service provision. We're in similar discussions with sites in Spain and some of the Central European countries. I think you're right. There will be some partnerships where we work on delivering doses, the practice of gallium-based radiopharmaceuticals in Europe is very evolved, and it's highly hospital-centric. There's a good reason for that.
You just don't have the homogeneity of regulatory environment in Europe that you do in the U.S. The networks that have evolved in the U.S. have done so against that regulatory backdrop, whereas in Europe it's very fragmented and the radiation handling aspects are unique country by country, and that's why it has a different profile. Certainly the opportunity that you've described is there, and it's a nice way for us to make the SHINE site fairly profitable from an operating vantage point early on.
Thank you. I might just switch to the U.S. part of that story on TLX591-CDx. You've set third quarter there as the NDA submission target. Right. Should we be treating that NDA as having sort of routine, kind of 10 months PDUFA sort of assessment phase, or am I missing something there that might expedite it? The investor deck sort of implies an early 2021 sort of launch. Am I missing something there?
Look, we never try to guess what the FDA will do. It wouldn't be appropriate, but what we can say is that we have some statistics on what prior approvals have been like for similar products. The FDA has a high degree of understanding of this technology. Every time we have a clinical site set up an investigational protocol or an expanded access IND, it goes back to the FDA, and they're intimately familiar with our manufacturing package. The advantage that Telix has from a regulatory approval pathway is that we're asking the agency to regulate a product, a box. We're not asking the agency to regulate a manufacturing process. Although that means that the FDA will have to audit our manufacturing partners for the product, we don't have to have a reference site inspection, for example, for a cyclotron facility or for a production facility.
Because we dispense our product under practice of pharmacy, which is a state-based regulation, we don't have the same burden that our counterparts do on the F18 side, which is where every single manufacturing site is regulated as a Part 212 GMP manufacturing facility. We have a much more streamlined rollout process, and that does have potentially an impact on the review period. Look, they can take all the time they want, and of course, the clock can stop and start again depending on how they feel about our package. We think that the product is relatively straightforward to review. The FDA has a high degree of familiarity with it, and it has the potential to be fairly quickly reviewed.
Thanks. Finally, from me, just on the numbers. If you maybe talk through the expense outlook for the remainder of 2020. I've seen what you said there in the 4C, should we model similar sort of overall to the first half? Will it be a bit of a step-up in the last quarter, I guess, as the ProstACT campaign rolls into action? That's it from me. Thanks.
Thanks, Shane. We're going to end the year with somewhere around AUD 21 million to AUD 22 million left on the balance sheet. That'll be our ending balance sheet for the year. I think that's fairly well extrapolatable from our 4C. That gives us ample financial resources to do the market launch for 591-CDx in the first half of next year. We have clearly stated in the past that we do not have the financial resources right now to run a phase III prostate cancer therapy program. The goal right now is to focus on the regulatory and the clinical trial readiness aspects, which will take us through until the end of the year. We have a little bit of cash set aside for starting to recruit Aussie patients into that trial, which of course, it has a very different price point for the company.
Adding U.S. patients in, let's say, by the end of Q1 or early Q2 of next year, that's going to require further capital. We've said consistently, I think, over the last 12 months that capital, it may come from a capital raise next year. It's a possibility. More likely it's going to come from partnering a commercial activity around that asset. To Hashan's question, why are we still committed to developing that asset? The answer is absolutely because we have a lot of commercial interest in it. It would be great, obviously, if we can leverage partner funding or partially leverage partner funding that will have a positive impact on the company's financial resources next year.
Thanks, Chris. That's all for me.
Thanks, Shane.
Your next question comes from Dennis Hulme with Taylor Collison. Please go ahead.
Good morning, Chris. My first question is also on TLX591. Can you talk us through the steps that you need to complete before you can commence recruiting patients in that study? Can you give us an indication of the likely cost of running that phase III study?
We'll be ready to recruit patients in Australia by the end of the year. Because of the additional manufacturing package requirements for the U.S., and we were trying to be conservative and say that it's likely going to be end of Q1 next year that we get the nod from the FDA to start, and that'll depend on a lot of things, and a phase III trial is obviously a much more complicated. It's a much higher bar. It's a bar, by the way, that we have jumped over before, but it's still a high bar, and that should be acknowledged. I don't see any barrier to us being up and running in the U.S. in the first half of next year in that trial. As I said, we can potentially start in Australia sooner.
In terms of giving an absolute budget for that study, that's been hugely dependent on our discussions with the FDA, which are not final yet. In our original planning, we said that the likely trial size would be around 600 patients. Internally, we budget, of course, for dropouts and for needing to recruit more patients for various operational reasons. We think that on the basis of the current trial design, which we are socializing with the agency, that we can improve that patient size, but it remains to be finalized.
I expect that we'll have that final trial, that statistical plan and trial sizing by the end of October or early November. I think we'll be in a good position to transparently disclose what we think that trial cost is going to be. I don't think we're going to get much change less from about AUD 50 million for the trial. Obviously, if we end up having to do either a larger statistical sizing or if we have to move to a more onerous endpoint, that cost could go up considerably.
Right. Okay. Thanks very much for that guidance. Secondly, with the TLX250 therapy, can you give us an idea of trial timing of those STARLITE trials?
Yes. It's a bit frustrating, but these STARLITE trials have been delayed mostly because of the impact of the pandemic. It's just been very slow to get academic centers up and running. In the case of the STARLITE trials, we're actually doing the product manufacturing in the academic environment. We're using nuclear medicine facilities in our trial sites, which is appropriate for sort of early to mid-stage studies like this. It hasn't been possible to do that manufacturing validation during this first wave of the pandemic. The good news is that we've finalized those protocols, those clinical protocols. The manufacturing, now that we've seen things starting to reopen a bit in the U.S., we've almost finished the manufacturing validation of the 250 lutetium product.
I would imagine in the next four to six weeks, we'll put the final touches on those INDs and get them filed. In some cases, the protocols are already going through institutional review, I don't expect there'll be a lot of lag time. We're still firmly on track, I think, to get these trials open before the end of the year. That's something we're very keen to see happen. Carbonic anhydrase IX is becoming a super interesting target. A lot of pharma attention on that target and those two STARLITE trials are a combination with immunotherapy studies. We really want to start to collect that data and get that patient experience as soon as we can.
Okay. Well, that's great to hear that they're likely to be underway before the end of the year.
Yeah.
Finally, if I can totally change tack just to your competitive Progenics, which has indicated that it expects to file in the middle of the fourth quarter. I'm just wondering, what's your expectations of the indications that Progenics is likely to file for? Do you think it'll just be biochemical recurrence or any likelihood that they might go for indications beyond that, in your view?
Well, we try not to second-guess our competitors too much. I think that their clinical trial strategy has been very robust and they have an excellent product. I fully expect that they'll have equally compelling data to put in front of the agency. I think we formed an internal view about what is our maximally competitive strategy, and I think once the FDA has accepted our NDA submission, we'll be in a position to much more forthrightly talk about our label plans or our labeling strategy, which will then, I think, in turn, answer that competitive question more clearly.
Okay. Well, that's great. Just finally, in relation to the European approval steps that you said that in a few months you'll have reached consensus with the other authorities. What are the next steps after consensus is reached? What's the steps from there to getting final approval?
It all depends a little bit on what that consensus yields. We're operating under the assumption that it's a fairly straightforward approval. Again, perhaps even more so than the FDA, the various European competent authorities know this technology very well. We've had a product dossier in, I don't know, 10 or 12 European countries now for, in some cases, a couple of years. Again, there's high familiarity and understanding with the product. Once we get to that 150-day clock, which is the consensus date, which will be around the end of the year, we've given a rough timeline because it can stop and start, so depends on what queries we get.
Let's say by the end of the year, we get agreement from the 14 countries that we've submitted to that the product is approvable, then it'll go to individual national review, and that'll be up to the whim of each individual competent authority on how rapidly they review the package. That's why some competent authorities enable the possibility of an interim temporary marketing authorization, which we are in discussions with several competent authorities about. Unlike the U.S., where as we approach NDA, the impetus to fill in a lot of FDA documentation starts to diminish, and customers will say, "Look, it's better for us to just wait until we get product approval because it's probably going to be the same sort of timeline." In Europe, there's much less impediment to just using the product.
We obviously don't get reimbursement for it, that limits adoption. In terms of clinical access to the product in Europe, in most countries, not all countries, but in most countries, there isn't much barrier to continued use of the product. We don't feel the same. We'd like to get reimbursement and maximal commercial value for our product in Europe, although we don't get a shabby price point for the kit in Europe today. We have a decent average price point. There isn't the same level of reluctance to use the product because of proximity to approval. Does that make sense?
Yeah. Okay. Yes. It's complicated and a little unpredictable. That's good that we can understand that. Okay, cheers. That's all the questions from me, Chris. Thank you.
Thanks for your time, Dennis. I realize we're going way over time, and people have got other calls to take. Maybe we'll take one more question if there is one.
Your last question comes from David Blake with BioShares. Please go ahead.
Yes. Hi, Chris. Just one minor question. You made a comment about revisiting the label. I think this is in discussions with the FDA. Can you just clarify what you meant by that?
Sure. When we originally disclosed our commercialization plan for the prostate imaging agent, we elucidated that our intended-to-treat patient population is biochemical recurrence. That's patients that have had an intervention with curative intent, that's a prostatectomy or radiation or a combination, and then have had a rising PSA post-prostatectomy. This is the indication that has probably the largest supportive data set around it, at least for our product, probably for all PSMA products. PSMA expression, which is the target that we image, PSMA expression is there for the continuum of prostate cancer, from very early prostate cancer, pre-prostatectomy, all the way out to late stage metastatic disease.
Based on conversations with the FDA, but also new emerging data, it's clear that we have the clinical data to support the utility in a much wider continuum of care for prostate imaging. Part of the delay, I'd say about half of the delay we've had in the NDA submission is just the machinations of working in a pandemic. The other half of the delay has been a concerted decision to consider broadening that label. For competitive and commercial reasons, and obviously sensitivity towards the Agency, we haven't really discussed what our final label will be. Once the Agency's had a chance to review our submission, then we'll start to talk more openly about what that scope of label is that we've submitted for.
Thanks for that.
Well, thanks very much. I think we'll wrap it up there. I appreciate your time and attention. I hope it was a useful update, and we certainly appreciate the enthusiasm and support of our shareholders. A lot of exciting stuff to look forward to over the next six months and beyond. Thanks for your attention.