Good morning, everyone. Thanks for joining us today for our 46th Growth Stock Conference. I'm Andy Hsieh. I'm the Research Analyst here at William Blair who covers Telix. I'm required to inform you that for a complete list of research disclosures or potential conflicts of interest, please visit our website at williamblair.com. We're pleased today to have Dr. Christian Behrenbruch, founder and CEO of Telix Pharmaceuticals, along with David Cade, Chief Medical Officer. The company is a global biopharma company specializing in radiopharmaceuticals. We're very bullish on this secular growth opportunity and added Telix to our conviction list earlier this year. With that, I'll pass it on to Chris and David to walk you through the story.
All right. Thank you very much, Andy. Good morning. Thank you for taking the time to listen to our story. I get to share the podium with David today, which is great, because I get to tell the high-level story. David has to hit you with all the detail. That's how we're going to split the presentation today. Just the customary forward-looking statements. We've been around for about 10 years. We're relatively new in terms of visibility, I think, in the U.S. landscape. It's just a bit over a year ago, we became a dual-listed ASX/NASDAQ company. We started off our origins in Australia, which a lot of people don't know is a very strong academic environment for nuclear medicine. Mainly because it's a remote island. You have to have your own infrastructure, otherwise you don't get healthcare.
Nonetheless, some of that capability has spread very well to the rest of the world, and we are now a global company. We're over 1,000 employees. Most of our team is based in the U.S., and most of our commercial activity is based in the U.S. We kind of break into five buckets of activities. First and foremost, and most of our R&D investment is in a very high-value therapeutics pipeline, which I will introduce to you, and then David will go into a few highlight topics. Historically, the company took the view that because radiopharma in its modern form is a fairly nascent industry, there are a lot of great ideas out there in academia, and the sort of value proposition of doing fundamental R&D in radiopharma was relatively low.
We took the view when we started about 10 years ago that there were lots of low-hanging fruit that actually should be commercialized rather than going out and trying to find new basic science. That said, a decade on, when we see billion-dollar deals being done for molecules that have been in three mice xenografts, there's actually now sort of a business case to go back and look a little bit more at fundamental R&D. We've started to do that through some acquisitions and some organic activity. The center pillar of our business is precision medicine portfolio. To simplify precision medicine, that's diagnostic imaging. The great thing about radiopharmaceuticals, you inject a patient with a molecule that's radiolabeled, you get something special that no other drug gives you, no other drug class gives you, which is a beacon.
It gives you a localization down to the millimeter where it is in your body, and it's a tragedy not to use that. What we do as a company, for every target that we develop a therapeutic, we develop an imaging agent, and it turns out that we've been quite successful in commercializing those applications. There's a lot of value in being able to image disease. You can imagine from an oncologist perspective, you turn up, you show a scan, and that scan is like your roadmap to therapy. The value proposition is very entwined. What it also does is it enables us to run smarter clinical trials. We select patients better, we tend to get better trial outcomes. Very important.
This year we'll do just shy of $1 billion of revenue in that business, which is important to our company because that's how we're funding our R&D. We're a unique organization. As much as I'd love to go out and ask you all to write a check every year to fund the company's R&D, we think it's better to go out and preserve your dilution and finance that R&D through earnings, which is what we do at the moment. We have a commercial team, so about a fifth of our organization is actually out there driving sales of radiopharmaceuticals. We think that that's important because it's not the same as selling other oncology products. In fact, when we sell a radiopharmaceutical, we are not selling a drug. We are selling a clinical workflow.
We have to explain how to image the patient, radiation safety, camera calibration, dosimetry protocols, waste recovery, all kinds of things that are part of that ecosystem. We need to deliver that as a solution to our customers. By the way, it turns out that that's a very big competitive differentiation as well. Last of all, I think those of you who have dabbled in radiopharma know this, radiopharma is just-in-time manufacturing. Some of these products have incredibly short shelf life. Our Illuccix product has a two-hour shelf life. We've got one hour to get it to the patient, one hour to administer it and scan the patient. These are just-in-time manufacturing, and if you leave that task entirely to other people, you probably, as your business scales, you probably hit some headwinds there.
We're very fortunate we have some great partners, but we increasingly take direct responsibility as well. Last year we delivered just under 3 million doses to patients. That vertical integration is really important to our strategy. Okay, it's a lot of time on one slide, but I promise I'll go faster. That's the background now. Just to let you know, these are our two FDA-approved products, both in the prostate cancer space. We had a very successful Illuccix launch, and our Illuccix business continues to grow. We launched Illuccix about five years ago. GOZELLIX is our newest lifecycle management product. It really extends the reach and clinical utility of Illuccix and has enabled us, as you'll see from our financials in a second, to really double down and capture some market share in what's a very complicated clinical and reimbursement landscape. We are commercially active in 22 countries.
We have approval and reimbursement in 22 countries around the world. The ex-U.S. part of the business is also something now that's starting to grow. We have a truly global coverage. This is really the impact of GOZELLIX. It's pretty dramatic, as you can see. The market overall for PSMA imaging, for prostate imaging, is still growing 5%-7% a year. We think that we have some label indications, which we'll talk a little bit about, that can further expand the size of the market. This is just by having a really good market access strategy and really covering that last mile of patient access in a smart way, that's what GOZELLIX has enabled us to do. This year's a big year for us. We have submitted our NDA for Pixclara, which is a glioblastoma imaging agent.
The PDUFA goal date is the 11th of September. For full transparency, that's a resubmission. We had a CRL last year from the FDA around a statistical analysis issue with our data set, which we resolved fully with the FDA. We're confident that this package is what the agency wants to see finally. Yeah, we're really excited to be launching that product this year. The Zircaix submission, this is a BLA submission, is sort of a mid-year-ish timeline for resubmission. We're a couple of months away from getting this back into the hands of the FDA. This was some manufacturing-related challenges, very complicated product. First time anyone had ever put a PET biologic in front of the agency. We've had a few challenges there, but renal cancer market's a massive market. It's a billion-dollar opportunity in its own right.
We're really excited to get this product away as well. When you think about what Telix can deliver just in the precision medicine portfolio, and I'm going to focus on this for a minute because when David talks to you about our therapies, you can imagine there's a fair bit of capital that's required to finance that R&D pipeline. This is how we're financing it. This is how we see the growth trajectory over the next few years. Today, with just the franchise we have with Illuccix and GOZELLIX and the growth of prostate imaging, we think that the market can get to sort of a AUD 2 billion-AUD 2.5 billion opportunity for our product portfolios. This is our realized market opportunity. With bypass biopsy study, this is about bringing prostate cancer really into frontline management of patients.
This is about addressing the fact that every year we do just over 1 million biopsies, but about 800,000, 750,000, 800,000 of them are of no benefit to patients. Either they're negative or they don't elucidate useful clinical information. We see about an 800,000 scan opportunity in the label expansion, which would more than double the size of the market for PSMA. Zircaix, as I've said before, is a really significant incremental growth opportunity in Pixclara. Between now and, let's say the next five years or so, this is the growth trajectory that we think our current pipeline of commercial stage, clinically complete. We continue to develop additional labels and indication expansion, but this is our baked business.
This is not sort of speculative, "Well, one day we might complete product development." These are completed products that have a very long revenue trajectory ahead from where we are today. It's very exciting. I mentioned in my long-winded opening slides, panel number 2 was going back to some basic R&D. As I mentioned, we've done some acquisitions lately. We've acquired some biologic engineering, protein engineering capabilities that allow us to explore some of these medium-sized targeting formats. Traditionally, radiopharma has been either very small molecules or very large molecules, but there's all kinds of things in the middle.
Especially as we start to think about next-generation isotopes like actinium, and lead, and astatine, we need things that are in that middle range because the pharmacology and the clearance organs and the requirements of those radiopharmaceuticals for those very high-energy isotopes are different than what we've traditionally had. We have now the capability to do that. We have two next-generation small protein formats going into the clinic towards the end of this year, and that's really exciting. The other thing that we have cooking, which we are not going to talk too much about today, but I'll take a question if there's one at the end. We had just announced a very significant partnership with Regeneron. It's a really exciting partnership, and I would need to explain to this room the biologics capabilities of Regeneron. I think it's a nice match.
We bring conjugation, radiochemistry, manufacturing, supply chain. They bring phenomenal antibody engineering, manufacturing expertise, including things like bispecifics. It opens up the whole door to just a next-generation suite of products. That collaboration is for up to 8 targets, initially 4 targets. Really, a lot of great science to be done ahead. It's either like that's an awesome pipeline exclamation mark. That slide, were it available, would show our entire pipeline. Maybe just to summarize non-visually, 3 major areas, urologic oncology, neuro-oncology, and musculoskeletal, things like sarcoma. We think that these are areas of high value in radiopharma. They're typically cancers where there's a degree of radiation sensitivity or the immunobiology is very supportive of using targeted radiation. We're mostly fairly late-stage programs.
This year we have three programs in prostate, kidney cancer, and glioblastoma that are in phase III trials. Okay, I went three minutes over my theoretical allocated timeline. David, you're up next.
Thanks, Chris. I was just sitting there thinking, yeah, well, I hope the next slides don't have exclamation marks across them all because I'll have to do a fair bit of improvisation. David Cade's my name, the Group Chief Medical Officer for Telix, based out of Sydney. You can probably tell there's an Australian accent up here. In radiopharma development, that's actually quite a very common phenomenon because we've got a very pragmatic research governance landscape in the country, which allows physicians to tinker and lead in radiopharma. I'd just like to make a statement, and I'd like to compliment you. I think you're in the right room. Why would I say that? Why would I say that you're in the right room?
The reason for that is that when I was a surgical intern in 1995, which sort of carbon dates me a little bit, in oncology, there were three modalities that we had: surgery, radiation therapy, and traditional chemotherapy. What's happened, we had those three sort of pillars of cancer care. What's happened since those times is we've had in the mid 2000s the biologic agents, Herceptin and Avastin. We've had the immuno-oncology agents, BMS was the leader in that, like pembrolizumab and nivolumab. We're up to sort of five main pillars, and I think the thesis that is really rapidly being proven is that radiopharmaceuticals are now a legitimate, rapidly mainstreaming sixth pillar of oncologic care. I think you're in the right place to hear about that. There's two things that I'd like to point out about our prostate pipeline.
What you can see here in that wavy line is the tumor marker that is unique to prostate cancer, known as prostate-specific antigen. That first sort of rise there is somebody like me. Maybe a little bit older than me, 10 years down the track, sort of mid-60s, doing as he should, seeing his family doctor every year to get his PSA tested, and it's starting to rise. It sort of peaks on that first peak, what causes the drop? That's a prostatectomy, or it's external radiation therapy with the intent to cure that gentleman. Most men are cured, but for prostate cancer, somewhere between 20% and 40%, it comes back, and that's represented by the rest of that line as it sort of goes throughout its wavy journey, as it comes back and we treat it comes back and we treat it.
Over to the right, we ultimately, unfortunately for a bunch of patients, we lose control of the tumor, and it continues its relentless rise as it spreads to the bony skeleton, and we can't treat it effectively anymore. What our thesis is that there's really two things that you would take from this. Is that, first of all, Telix takes the approach that no man is left behind. You'll see that our trials are truly global trials that encompass enrollment of patients in North America and Europe, as you'd expect, but also China, Japan, and Australia. That when we generate data, we'll be able to take those data to the respective regulators and seek approval for all men across the globe.
The second thing that you should take away from this is that we have the approach that we aim to be with the patient across their entire journey. I'll go into a little bit more detail on what that means in a moment. We've got differentiated modes of action that are matched to the disease state and the clinical needs of the patient as they progress across the journey. On the left-hand side, TLX597 is a very exciting asset that has a unique dosimetry profile for early metastatic prostate cancer. 591, which is a flagship program, is intended for metastatic castrate-resistant prostate cancer. As we unfortunately, ultimately lose control of the disease, there's a requirement for palliation of bone pain, we have assets that are in development for bone pain over on the right. This is TLX591 in a little bit more detail.
Again, I think the beauty of radiopharmaceutical development is it's characterized by imaging. With the imaging, we can ascertain where the disease is, we can ascertain how to treat the disease, and we can ascertain how our treatment causes the disease to respond. This asset was presented yesterday at ASCO by Dr. Sartor. He presented the part 1 results from our phase III ProstACT global trial. Really, what this data showed was that combining TLX597 with standard of care androgen receptor pathway inhibitors or with chemotherapy in the form of docetaxel is both safe and it appears that the data that we have from earlier trials supports the advancement into part 2, which is already underway. That's the randomized treatment expansion in this trial.
This is a differentiated asset, different to the existing and currently being developed small molecules, where it uniquely hits the target, PSMA, on tumor-expressed PSMA. It does not hit normal tissues anywhere near to the extent of small molecules. It keeps away from the kidney, it keeps away from the salivary gland, and it allows very long residence time on the tumor target. That means that we only need to dose a patient twice, two weeks apart, and it has a very low toxicity profile, very low kidney injury, very low xerostomia or dry mouth. What you can see in the imaging there is on the left-hand side is the baseline gallium PSMA PET that articulates exactly where the disease is. You can see this patient mostly has disease down their spinal column.
There's a little bit of disease there on the right-hand side in the ribs, and down in the pelvis as well. When you treat them, what you can see on the imaging is that at four hours and 24 hours, because this is an antibody that delivers the radiation, it's in the circulation there. You can see the circulation, and you can see the main clearance organ, which is the liver. As time progresses across four days, seven days, and now to almost two weeks, there's uptake that you can see almost exactly matches the diagnostic scan that we started with at baseline. You can see progressive uptake exactly where the tumor is in the skeleton, and that is, as I said, prolonged, really prolonged out to about two weeks. That's irradiating those tumors for a very long period of time.
This study's underway in its part two randomized treatment expansion in multiple countries where it's been approved. As it was described yesterday, this is a very exciting trial. This is the asset that was the most left-hand asset, which is known as TLX597. I think there's probably three points to take away from this quite dense slide. First of those is this is a next-generation small molecule candidate for early metastatic castrate-sensitive prostate cancer. What this does is very unique compared to the existing PLUVICTO agent and agents that are in the similar class, which is that it has demonstrated a very, very low dose to the salivary glands, which is a tissue that the current first-generation small molecules hit very hard, leading to dry mouth, which is a very problematic side effect that impacts quality of life.
It has a very, very low dose to kidneys, which is a sensitive organ that we want to keep away from because high dose to kidneys leads to chronic renal insufficiency and renal damage, so we must keep away from kidneys. While at the same time, delivering an extraordinarily high dose. It appears to be a 2x or 3x dose to the tumor compartment, whether it's the soft tissue tumors or the bony tumors. What that means is if you put it all together, there's a very favorable dosimetry profile, high to tumors, very low to the normal tissues. If you think about what does that enable you to do, there's an extraordinary study that's rapidly enrolled in Sydney. It's now a multicenter trial known as OPTIMAL-PSMA. What that has done is really two things.
Because of that dosimetry profile, it has enabled the turning up of the volume, so in other words, increasing the amount of activity, the radioactivity injected, while also concertinaing together, pushing together the first three doses. You can see it there in the bottom. Again, the images tell the story. Instead of the doses being given on today and then in six weeks and 12 weeks and 18 weeks and 24 weeks, like Pluvicto is, the first three doses are concertinaed together over day one, day three, and day 15. What that does is it enables to hit the target after the first dose causes more expression of the target. You come along on day three and treat again when there's much more target available. The tumor uptake is enhanced. This is a thesis known as dose intensification.
The addition to that will be dose adaptation, where the clinician only treats when the target is present. That's quite extraordinary work that is still being done with second-generation small molecules that will advance, we believe, on what we have today with Pluvicto and other first-generation small molecules. Moving to glioblastoma. Neuro-oncology is a fundamental part of the portfolio. This is TLX101, which is a first-in-class candidate for glioblastoma. Glioblastoma, it's not really a drug development graveyard like Alzheimer's drug development has been. Glioblastoma, it's been a drug development desert where we really haven't had anything new since the Stupp regimen of chemoradiotherapy was established probably 20 years ago. The options are desperately needing to be expanded. There's 15,000 new diagnoses of glioblastoma a year in the United States. The vast bulk of those, about 90%, get treated with maximal surgical debulking.
If you just think about those words, that's a cancer operation where the surgeon says to his or her patient, "I'm going to maximally surgically debulk you, but there will be tumor left behind." What does that lead to? 90% of these patients ultimately recur. 90% operated, 90% recur, and therefore, we need second-line options desperately. If you look at the guidelines, second-line options include putting the patient on a phase I trial, which is really a hopeless situation. If you look at the imaging here, this is a patient that on the left-hand side, that's the MRI scan. You can see a lesion on the left-hand side of the image. That's the right-hand side of the brain because we're looking from the toes upwards in the temporoparietal lobe.
The next sort of colored images across are the baseline FET-PET images, and you can see very, very high uptake biologically, in the same area. The third image across is the fused MRI with the PET scan. That's the fused MRI PET. The patient in the sort of right-hand group of images has been treated, and the SPECT is the imaging that we do after treatment. What it shows there, when you sort of look at that and say, "What do I take from that?" It shows that the therapy agent, which is Iodine-131, phenylalanine, which is an amino acid that crosses the blood-brain barrier, has gone exactly to where you would want it to go based on the pre-treatment imaging. The early data from this asset has been quite compelling.
Small trials, mostly phase I and phase II trials, have shown a very high level of tolerability. We haven't achieved dose-limiting toxicity in those studies. It crosses the blood-brain barrier. You can see it gets to where it needs to get to, and it's done so with a very low toxicity profile. From those early studies, the survival durations, and you've got to take that with a grain of salt because they're small phase I studies, the survival durations have been beyond 30 months from diagnosis, and beyond 12 months from the time of initiation of treatment. If you rack and stack those results against what else is out there and what we can achieve, they are extraordinarily compelling results that warrant further development of this asset. IPAX BrIGHT, that's a phase III study that's underway. It's got part one and part two.
Part one is where we aim to optimize the dosing schedule, part two will be a randomized treatment expansion that will be the pivotal registration component of that study. Finally, TLX250. This is back to urologic oncology, this time kidney cancer. What this builds on is the ZIRCON phase III trial with the same asset but labeled with zirconium-89 as a new diagnostic agent for renal cell carcinoma. The ZIRCON trial was a phase III trial in patients with indeterminate renal masses. That's a mass that has been picked up on some form of imaging, we don't know what it is. These patients were scheduled for surgery. They had a scan beforehand, what that trial showed was that this agent, known as Zircaix, has a very high sensitivity and specificity for picking up renal cell carcinoma.
The target is carbonic anhydrase 9 or CA9, that will ultimately lead to registration of Zircaix for the imaging of renal cell carcinoma. That's a relatively proximal event. This therapeutic builds on an imaging agent, the same delivery vector, the same delivery moiety, but this time, not with an imaging isotope, with a therapeutic isotope known as lutetium. Again, you can see the images there in the middle. This is from our STARSTRUCK trial, which was lutetium TLX250, together with a Merck drug known as peposertib. What you can see there is, on the top panel, that's the imaging agent, which ultimately will be known as Zircaix, zirconium-89 girentuximab, targeting carbonic anhydrase 9, and really clearly articulating this patient's metastatic renal cell carcinoma in the tailbone or in the sacrum there, what we'd call the tailbone.
Then treated with this agent, a number of cycles, and then re-imaged again, and you can see a markedly reduced biologic activity there. LUTEON is the phase III trial. It's underway in Australia. It's just been approved with an IND for expansion to the United States, and that will start enrolling. It's enrolling in Australia. It will start enrolling in the United States in the coming quarter. That's a very sort of dense and jam-packed zip through on the therapeutic program, but we're very happy to take any questions.
In the one minute that's left.
Correct.
Six seconds. Maybe we should step outside.
We'll loiter around.
We'll continue our guest. If you have quick questions, just ask. The guest is Telix.
Yeah.
Upstairs. You can follow us, and that's going to be in ten minutes.
Yeah. Thank you for your time.