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Conference · 2026-06-02
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Good morning, everyone. Thanks for joining us today for our 46th Gross.Conference. I'm Andy Shea. I'm the research analyst here at William Blair, who covers Tealix. 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. So we're pleased today to have Dr. Chris Barrenbrook, founder and CEO of Tealix 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, and good morning, and 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, and then David has to hit you with all the detail. So that's how we're going to split the presentation today. Just the customary forward-looking statements. So we've been around for about 10 years, but 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 and you have to have your own infrastructure, otherwise you don't get healthcare. But 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 there were, 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. So 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. So we've started to do that through some acquisitions and some organic activity. The center pillar of our business is precision medicine portfolios. Now, to simplify precision medicine, that's diagnostic imaging. The great thing about radiopharmaceuticals, you inject a patient with a molecule that's radio-labeled, 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. So 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. And you can imagine from an oncologist perspective, you turn up, you show a scan, and that scan is like your roadmap to therapy. So the value proposition is very entwined. But what it also does is it enables us to run smarter clinical trials. So we select patients better, we tend to get better trial outcomes. So very important. And this year we'll do just shy of a billion US dollars of revenue in that business, which is important to our company because that's how we're funding our R&D. So 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're selling a clinical workflow. So we have to explain how to image the patient, radiation safety, camera calibration, dosimetry protocols, waste recovery, like there's all kinds of things that are part of that ecosystem. So we need to deliver that as a solution to our customers, and by the way, it turns out that that's a very big competitive differentiation as well. And then last of all, and I think those of you who have dabbled in radiopharma know this, radiopharma is just-in-time manufacturing. So some of these products have incredibly short shelf life. Our Lucex product has a two-hour shelf life. So 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. And last year we delivered just under three million doses to patients. So 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 Ellucyx launch and our Ellucyx business continues to grow. We launched Ellucyx about five years ago. Gazelix is our newest lifecycle management product. It really extends the reach and clinical utility of Ellucyx and has enabled us as you'll see from our financials at 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 So we have approval and reimbursement in 22 countries around the world. So the ex-US part of the business is also something now that's starting to grow. So we have a truly global coverage. And this is really the impact of Gazelix. It's pretty dramatic, as you can see. The market overall for PSMA imaging, for prostate imaging is still growing 5% to 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. but this is just by having a really good market access strategy and really covering that last mile of patient access in a smart way. And that's what Gazelix 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. But, so yeah, we're really excited to be launching that product this year. There's a KX submission. This is a BLA submission. It's sort of a mid-year-ish timeline for resubmission. So we're a couple of months away from getting this back into the hands of the FDA. This was a manufacturing, some manufacturing-related challenges, very complicated product. First time we'd ever put, that anyone had ever put Pet Biologic in front of the agency. So we've had a few challenges there, but renal cancer market's a massive market. You know, it's a billion dollar opportunity in its own right, so we're really excited to get this product away as well. And so when you think about what Telix can deliver just in the precision medicine portfolio, and I'm gonna focus on this for a minute because when David talks to you about our therapies, you're gonna 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. So today, with just the franchise we have with Elucics and Gazelics and the growth of prostate imaging, we think that the market can get to sort of a two, two and a half billion dollar 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. So this is about addressing the fact that every year we do just over a 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. So we see about an 800,000 scan opportunity in the label expansion, which would more than double the size of the market for PSMA. Then Xerchaix, as I've said before, is a really significant incremental growth opportunity in PixClara. And so between now and, so 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, I mean, we continue to develop additional labels and indication expansion, but this is our baked business. So 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. So, you know, it's very exciting. I mentioned in my long-winded opening slides, panel number two 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, and 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 so 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're not gonna 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. 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 biospecifix. So it opens up the whole door to just a next generation suite of products. So that collaboration is for up to eight targets, initially four targets. So really a lot of great science to be done ahead. It's either like, that's an awesome pipeline exclamation mark, but that slide weren't available, would show our entire pipeline, but maybe just to summarize non-visually, three major areas, urologic oncology, neuro-oncology, and musculoskeletal, so 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 and so and we're you know mostly fairly late stage programs so this year we have three programs in prostate kidney cancer and glioblastoma that are in phase three trials. Okay I went three minutes over my theoretical allocated timeline. David you're up next.
Thanks Chris. I'm 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. So David Cade is 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 you know I'd like to compliment you I think you're in the right room now 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 and what's happened you know we had those three sort of pillars of cancer care. What's happened since those times is we've had in the mid sort of 2000s the biologic agents, acceptin and you know Avastin, we've had the immuno-oncology agents you know BMS was the leader in that like Pemprolizumab and Nivolumab so 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. So 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 tumour marker that is unique to prostate cancer, known as prostate-specific antigen. and that first sort of rise there is it's somebody like me you know maybe a little bit older than me you know ten years down the track you know sort of mid-sixties 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 and then what what causes the drop that's a prostatectomy or it's external radiation therapy with the intent to cure that gentleman and most men are cured but the prostate cancer somewhere between 20 and 40 percent it comes back and that's the 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 it comes back and we treat it but 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 um and we and we can't treat it effectively anymore so what what what our thesis is uh is that there's really two things that you would take from this is that first of all no man uh telex takes the approach that no man is left behind so 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 so that when we generate data we'll be able to take those data to the respective regulators and seek approval for all men you know across across the globe. The second thing is that you should take away from this is that we have the approach that we aim to be with the patient in across their entire journey and I'll go into a little bit more detail on what that means in a moment but 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. So on the left hand side Telex 597 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 and as we unfortunately ultimately lose control of the disease there's a requirement for palliation of bone pain and so we have assets that are in development for bone pain over on the right. So this is Telix 591 in a little bit more detail and again I think the beauty of radiopharmaceutical development is it's characterized by imaging and so 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. So this asset was presented yesterday at ASCO by Dr. Burrata. He presented the part one results from our phase three prostate global trial and really what this data showed was that combining Telix 591 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 two, which is already underway. That's the randomized treatment expansion in this trial. So this is a differentiated asset, different to the existing and currently being developed small molecules where it uniquely hits the target PSMA on tumour expressed PSMA. It does not hit normal tissues anywhere near to the extent of small molecules, so it keeps away from the kidney, it keeps away from the salivary gland, and it allows very long residence time on the tumor target and so 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. And so what you can see in the imaging there is on the left hand side is the baseline gallium PSMA PAT that articulates exactly where the disease is and 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. Then when you when you treat them and what you what you can see on the imaging is that at 4 hours and 24 hours because this is a antibody that delivers the radiation it's it's in the it's in the circulation there you can see the circulation and you can see the main clearance organ which is the liver. But 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. So you can see progressive uptake exactly where the tumour is in the skeleton and that is, as I said, prolonged, really prolonged out to about two weeks. so that's irradiating those tumours for a very long period of time. So this study's underway in its part two randomisation, sorry part two randomised treatment expansion in multiple countries where it's been approved and 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 Telix 597. Now, 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 Plavicto 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 something that 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 2 or 3x dose to the tumor compartment whether it's the soft tissue tumors or the the bony tumors so 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 so if you think about what does that enable you to do there's an extraordinary study that's rapidly enrolled in Sydney that's now a multi-center trial known as optimal PSMA and what that has done is really two things it is enabled because of that dosimetry profile it is 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 and 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 Plavicto is the first three doses are concertinaed together over day one day three and day 15 and 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 so the tumour uptake is is enhanced so this This is a thesis known as dose intensification and the addition to that will be dose adaptation where the clinician only treats when the target is presence and 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 Plavicto and other first generation small molecules. Moving to glioblastoma, so neuro-oncology is a fundamental part of the portfolio. So this is Telix 101 which is a first-in-class candidate for glioblastoma. Now glioblastoma is, it's not really a drug development graveyard like Alzheimer's drug development has been, glioblastoma is more, it's been a drug development desert where we really haven't had anything new since the stoop regimen of chemo radiotherapy was established probably 20 years ago. And so 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 and if you just think about those words that's a it'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 tumour left behind. So what does that lead to? 90% of these patients ultimately recur. So 90% operated, 90% recur and therefore we need second line options desperately. If you look at the guidelines second line options include put them put the patient on a phase one trial which is which is really a hopeless situation. So 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 PET PET images and you can see you know very very high uptake biologically in the same area and then the third image across is the fused MRI with the PET scan that's the fused MRI PET and then 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 and what it shows there when you sort of look at that and say what do I what do I take from that it shows that the therapy agent which is iodine-131 phenylalanine which is a 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 and so the early data from this this asset has been you know quite compelling small trials trials, mostly phase one and phase two trials, have shown a very high level of tolerability. We haven't achieved dose-limiting toxicity in those studies. So 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. But from those early studies, the survival durations, and you've got to take that with a grain of salt because they're small phase one studies, the survival durations have been beyond 30 months from diagnosis and beyond 12 months from the time of initiation of treatment so if you rack and stack those results against what else is out there and what we can achieve achieve they are extraordinarily compelling results that warrant further development of an of this asset so IPAC Sprite that's a phase three study that's underway it's got part one and part two part one is where we aim to optimize the dosing schedule and part two will be a randomized treatment expansion that will be the pivotal registration component of that study. And then finally TLEX-250 so this is back to urologic oncology this time kidney cancer and what what this builds on is the zircon phase 3 trial with the same asset but labeled with zirconium 89 as a new diagnostic agent for renal cell carcinoma so the zircon trial was a phase 3 trial in patients with indeterminate renal masses that's a mass that has been picked up on some form of imaging and we don't know what it is and so these patients were scheduled for surgery they had a scan beforehand and what that trial showed was that this agent known as Xerchaix has a very high sensitivity and specificity for picking up our renal cell carcinoma and so the target is carbonic enhydrase 9 or CA9 that that will ultimately lead to registration of zirkaics for the imaging of renal cell carcinoma that's a relatively proximal event so 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 and so again you can see the the images there in the middle this is from our starstruck trial which was lutetium TLX 250 together with a Merck drug known as Pupositib and what you can see there is on the top panel that's the imaging agent which ultimately will be known as zircaix, zircanium-89-durintuximab, targeting carbonic anhydrase 9 and really clearly articulating this patient's metastatic renal sore carcinoma in the tailbone or in the sacrum there, what we call the tailbone. And then treated with this agent a number of cycles and then re-imaged again and you You can see a markedly reduced biologic activity there. So Luteon is the phase three 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 in the, it's enrolling in Australia, it will start enrolling in the United States in the coming quarter. so that's a it's a very sort of dense and jam-packed zip through on the on the therapeutic program but we're very happy to take any questions in the one minute that's left correct or six seconds maybe maybe we should step outside and then we'll loiter around thank you for your time