Welcome everyone to the afternoon of day two of the Jefferies London Healthcare Conference. My name's Dave Stanton. I'm part of the Australian Healthcare Research team. It's my very great pleasure to have Chris Behrenbruch, CEO of Telix, with us here today. As you may know, Telix develops molecularly targeted radiation products for unmet needs in cancer care. Its lead products is Illuccix, as we know. The format today is a presentation followed by a Q&A session so we'll get right into it, and thank you, Chris. Thanks, David. Hopefully, you can all hear me well. Appreciate the opportunity to present Telix to you today. Just the customary disclaimer. For those of you that don't know the company, we're really one of the leading companies in the radiopharmaceutical space, which I think is fair to say is enjoying a bit of a renaissance at the moment. We are a commercial stage company, so our lead program, Illuccix, is a PSMA imaging agent, that's got approval right now in the U.S., Canada, Australia, and we get New Zealand for free as part of approval in Australia, and we are, of course, expanding that product into other countries in Europe and the APAC region. We also have two more follow-on products in diagnostic imaging. I'll caveat we're not an imaging or a diagnostics company. We're a therapeutics company that believes in precision medicine, but we get a chance to monetize these products, kind of in advance of their therapeutic counterparts, and I'll go through the pipeline a bit more in a minute. We also just put out some, really exciting data, around our prostate cancer therapy program, which has now started phase III trial, globally. So I'll, I'll come back and talk around some of the key learnings from that data and, you know, the pipeline more, more generally. These, these numbers are in Australian dollars, so you sort of have to multiply it by 2/3 to get the U.S. dollar on a good day. But, but the point of it is, is that we have a rapidly growing business. We've, we've been commercial for about 18 months. We're doing well over AUD 500 million, and so let's call it $330 million U.S. annualized in revenue, and we're funding a pretty robust R&D pipeline. Inclusive of R&D and manufacturing scale-up for commercial applications, we're financing about $100 million of R&D and manufacturing expenditure out of earnings, which I think in the current conditions, in the current environment, it's a great position for the company to be in. Gives us a lot of optionality. I'm only going to focus on the core pipeline today. We have another slide I could show you that has a bunch of early-stage, actually, mostly now clinical-stage programs around our alpha emitter and some of our surgical applications, but these are the ones that I would say 90% of our R&D expenditure is going into. Clearly, you can see, as I alluded to before, the imaging products are typically a phase ahead of the therapy programs just because of the speed and cost of clinical trials. So Illuccix is launched. Bless you. Illuccix is launched, our renal cancer program has just finished its phase III development, and we're a few weeks away from filing a BLA. It's still a corporate objective to get that done before Santa comes, which will be, I think, a really nice Christmas present for the company. Our NDA filing for our brain cancer program will also happen very near term, probably around February of next year. It's had a slight delay in terms of putting the package together. It's actually a lot of work to file a BLA, BLA and an NDA at the same time, so kind of can forgive ourselves a little bit on that. So, you know, really the imaging programs are a little bit more advanced but we're getting great therapy data all the time. As I mentioned, our prostate cancer program's in phase III. We have two phase II trials running in combination with IO in renal cancer for the TLX250 program, and then we're getting quite a lot of exciting data, some really promising signs of anti-tumor effect in our glioblastoma program, and that will certainly be a focus of concentration for the company in 2024. So at the moment, if I had to kind of condense. We have a lot going on in the company, but the four most important value drivers for the company right now are growing and building Illuccix. So some of the acquisitions and indication expansion that we're investing in right now is about building what we think is a unique position in prostate cancer imaging. As you'll all appreciate, the indications for PSMA imaging right now sit around a prostatectomy so high-risk men going into prostatectomy and then biochemical recurrence, and we see the urologist, who's a surgeon principally, as a key stakeholder to further engage. And so some of the investments that we're making are around answering the question of: How do we bring molecular imaging into the operating theater, and how do we make PSMA imaging something transformative to the quality of surgical outcomes? And so that's one of the sort of spins that we've put on it, and it's an area where we continue to seek to differentiate ourselves. It's really exciting to be in phase III finally with the TLX591 program. I'm going to talk a bit more about this asset and why it's so differentiated, and I think there's a lot of interest in the PSMA therapeutic space right now. And then I've mentioned our two other product applications. So if I could help you visualize the company today, you know, we have four markets, obviously, the big one being the U.S., where we're active with Illuccix. So really single product, single geography in terms of the commercial profile of the business. If we move forward to this time next year, we hope that we'll be in about 24 countries with Illuccix. We'll have three products launched, so really, the next 12 months is a big inflection point for the company if we hit all of our commercial and regulatory milestones. So just a bit on our clinical programs. I did caveat that we have a lot going on in the company, and I think this slide illustrates it well, and I'm not going to go through it line by line but just to show this is a snapshot of all the clinical studies we have running. We have over 20 studies running right now that are either company-sponsored or partially funded investigator-led trials in a pretty wide variety of indications, and I expect that we'll have tick boxes next to all of these by the end of this year. I think we've already accomplished quite a lot, frankly, in 2023. The highlight, of course, being getting our phase III trial up and running for the prostate cancer therapy program. Personally, I'm really keen to see what happens in 2024 with our renal cancer programs. It's clear that radiation and immuno-oncology together is something exciting, and renal cancer is pretty much the ideal cancer to study that in. So, you know, data readouts next year will be very informative about how we take that program into pivotal trials. So a bit on TLX591. You know, this is clearly not a controversy-free program, and it's garnered a lot of attention, particularly as PSMA therapeutics have taken off, and with most of the market being focused around small molecule programs, this is quite a different approach. There's a lot of mythology in nuclear medicine about why we don't have biologics to deliver radiation, but just like in the antibody-drug conjugate space, the successive generations of products evolve, and we have better ideas around how to dose patients and manage toxicity. We've clearly demonstrated with this asset that we can do that. Although we target PSMA and we deliver lutetium, that's where the similarity ends. Frankly, the biology of delivering radiation with a biologic is completely different. We have a much better internalization and retention characteristics. We irradiate the tumor much more efficiently. We have a dosing regimen that is two shots, 14 days apart. That's the complete course of therapy. We inject 1/12 of the amount of radiation into the patient in terms of millicurie activity of lutetium. That has huge impact on ambulatory management, cost of goods. We have a hepatically cleared agent, so we don't have Godzilla vomit when we inject a patient from a radioactive vomit. We don't have urinary excretion of a product during the observation period, so it's just a lot easier product to use. We don't have salivary gland toxicity. We don't have lacrimal gland toxicity. We don't get ganglia radiation, so we don't have back pain. There's just a whole lot of reasons why this approach is differentiated. So, you know, and I think, you know, in our presentation, you can see there's, there's just a kind of a comparative table here about why we've taken this approach and why we think it's so promising. And what it will yield ultimately is that medical oncology will be able to refer a patient to a very short, sharp stint in nuclear medicine and then go back to medical oncology for ongoing care. And we think that that's an important dynamic, particularly in the U.S. market. So we're really gung ho about developing this asset and bringing its benefit to patients. I think I've talked about all of these. We recently published a few weeks ago the top line results of the ProstACT SELECT study. So the SELECT study is actually a radiogenomic study. It's to demonstrate that Illuccix can select patients for therapy, so a small molecule can predict the biodistribution of an antibody. We've been told by regulators that that's a requirement, you know, for this class of products. But what it did, it enabled us to present a safety data set, quite a good size safety data set, almost 30 patients at the dosing and intended to treat patient population of ProstACT SELECT. And I think the key outcome, and I'm going to show you a few slides from that, but the key outcome is that, the safety profile is very comparable between other classes of PSMA agents. Historically, all of our data was in very late stage, kind of pre-palliative care patients and, those are patients that have very little hematologic capacity. And so the toxicity is not really indicative of a product, or let's just say that the incremental tolerability is low. And then what we've showed is that this has a very comparable AE profile, and you can see that here in terms of the serious cytopenias, very mild non-hematologic events. And so if you line up other assets in this space side by side, you really have a very comparable, comparable profile. And so I think that, you know, again, it bodes very well for the perception of this asset from clinicians. But this is really the magical slide. This, in my mind, illustrates the specificity of antibodies. I think everybody in this room knows, you know, we have exquisite selectivity with antibodies, and in the case of targeting PSMA, we have exactly the same outcome. We have an asset that is selective for tumor-expressed PSMA. It doesn't hit endogenous PSMA expression. You can see that the key toxicities or off-target effects that you're interested in, particularly renal, salivary, red marrow, bladder, these are much, much lower when you use an antibody-directed approach. So ultimately, that's going to have some pretty major impacts for the utility of this, this asset. One of the nice things about the SELECT study is that we did sequential dosimetry. So these were, we did multiple patient dosimetry, or multiple time point dosimetry studies, so you can really see what the internalization or retention is. So this shows how the targeting agent is taken up over a 10-day period of time. So again, the pharmacology of this thing is totally different than small molecules, which are under first-pass renal clearance, target, clear, fast, gone. So this is a very, very different profile. And so the consequence, we get this kind of slow burn to internalization and retention. We don't get this very hard irradiation of a tumor and so our PSA response profile is very different. We presented some case studies when we launched the data that showed that, in some cases, we didn't achieve a PSA nadir for six months or a year after injection. So it's a, it's a very, very different treatment response profile, and as we get more clinical experience with these assets, we understand that the response profile is not what we see with small molecules and needs to be further understood. All right, just a quick one on Illuccix, because there are some people in the audience that are, of course, most interested in our commercial programs. We continued to see great growth in the Illuccix business last quarter, and our customer mix, which shows that we're getting a higher proportion of 340B patients in the United States, really demonstrates that we are taking share from our competition. So, I think, you know, it's a great financial performance for the company over the last 12 months, and we expect that trajectory to continue to grow. We have put out some updated market TAM assessments, as has our competition, and we think that there's still plenty of room to go in this market, lots of opportunities to grow. And part of that is gonna be through indication expansion through some of the technology bolt-ons that we've done. So I've mentioned already the surgical indications and so forth. From a revenue perspective, we're expecting next year to be able to add two more products, so that I think that will meaningfully increase our revenue trajectory as a company. We've made a couple of acquisitions and investments, and I thought it would be good just to kind of briefly speak about them. I mean, I think I've already explained how we see the urologist as a key stakeholder for Illuccix, so being able to provide additional tools and technologies to support that is very positive. We made a little bolt-on acquisition around AI, which will provide some potential indication expansion for Illuccix as well. So all in all, this is really about how do we develop the new indications for our PSMA franchise that will, you know, grow it and protect it into the future. We are adopting a little bit of a med tech component to this. Nuclear medicine is actually very med tech dependent, and so we see that as kind of a natural evolution of the company. It's not a distraction as a pharmaceutical company. It's really additive, and it augments some of the capabilities that we want to bring to the physician. So just to wrap up, these are the accomplishments of the year so far. You know, we've really, I think, achieved a lot in terms of our key focus areas, and of course, the last thing is to get done for 2024, 2023, early 2024 is the 2 new drug submissions. We've got a few other data readouts between now and the end of the year, the gray bubbles that are not yet filled in. But yeah, overall, a lot of accomplishments, I think, from the company for the year and a lot to look forward to in 2024. David, over to you for Q&A. Thanks very much, and if anybody's got a question, you're more than welcome to raise your hand and there'll be a microphone that comes around, or you can just ask it, and I'll repeat it so we get it recorded. But I guess to get started, though, you know, can you, I guess can you talk to the ProstACT SELECT trial, please, Chris? And you know, when might we see more data from ProstACT SELECT, and what kind of data can we expect? Yeah. So we only have about half of the patients progressed on that study, so we weren't able to put out a complete PSA summary or any PFS data. It's a little hard to tell. Yeah. Because patients progress very slowly. Like, it's not a rapid progression on the drug, so I'm hoping maybe by March or April that we'll be able to get PFS data out, but that's hoping for patients to progress. So I don't really know. Yeah. I don't really know when that's gonna be, but, yeah, hopefully, you know, not too far into the future. Yeah. Understood. And then in terms of the ProstACT, you know, trial, the phase III trial that you're doing in prostate cancer for TLX591, can you sort of explain why you're doing the three sort of related ProstACT trials within it, the SELECT and then ultimately into global? Yeah, it's caused a bit of confusion. So we have the SELECT trial because we know that patient selection is important for this class of assets, and Illuccix is our patient selection tool, and we've got to demonstrate that we can predict the targeting and biodistribution of our therapy with a small molecule. So that's why we did the SELECT study. The Target study is a kind of a unique opportunity for us to study lutetium PSMA in a very early patient setting. There are some academic studies that are looking at lutetium targeting essentially at prostatectomy as an adjuvant. We think that combining it with external beam radiation makes a lot of sense. You know, in some countries, external beam radiation is a prostatectomy, and so looking at the combined dosimetry of radionuclide therapy and LINAC is quite interesting. So that's a kind of first-line glimpse into the future. So we were keen to study that. We see that as kind of a direction that prostate cancer radionuclide therapy is gonna go. And then the ProstACT GLOBAL study, which I think is very comparable to the SPLASH and the PSMAfore trial, is really to look in that second-line setting where I think there's a sweet spot for radiopharmaceuticals. We think our trial has a more real-world standard of care arm, which, because we allow concurrent taxane usage, and what we see is more and more use of taxane in that second-line setting. So we've let it be physician's choice, whether you use an androgen or a taxane, and I think that's very differentiated, and it will be good for patient recruitment for the study. We've had a lot of positive feedback about that from investigators. Understood. Then, where are we in terms of rolling that, the ProstACT GLOBAL out, particularly in the U.S., please? Yep. So the IND is just about ready to file. Yep. It's taken us a bit of extra time to get the manufacturing to the standard that's required for a phase III trial in the U.S. but we're there, or we're just about there. And so it'll have a run-in study first to do essentially a bridging to the new manufacturing package, and then, and then, you know, the full trial will commence. We're also hoping to add European patients towards the middle of next year as well. So overall, we're expecting to get about 60-70 sites into the study globally. You know, likely timeline for top-line results from ProstACT GLOBAL? Well, we haven't really given much guidance on that but we're hoping that we can recruit the trial in about 18 months. I think now that the trial's launched and we're starting to get sites online, we should see a good acceleration of recruitment. I think, you know, based on expectations of PFS and OS for this asset, you know, I think the soonest that we'll see something from an interim readout is maybe towards the back end of 2025. We do plan to do an interim after the first 120 patients, and I think that will provide a meaningful readout to partners and to the market on how the asset's tracking in that study. Understood. Again, any questions? Otherwise, I'll keep going. But if we move on maybe to kidney and the TLX250- CDx, you've got, you're talking about a BLA prior to Christmas, hopefully. Yeah. Just in time for Santa, as you said. Yeah. You know, after that, so what's the, Can you run through the timeline after that's submitted, please? Yeah. So the FDA has granted us a breakthrough designation for that asset, and we've agreed on a timeline for a rolling submission because it's a biologic, and we need to submit the PPQ runs as part of the submission. So we will be submitting with 1 manufacturing run, and then the other two manufacturing runs will be completed early next year and then added to the package towards the back end of Q1. So I'd say as a sort of ballpark, we would hope, and we haven't been given a PDUFA date, but we would hope maybe sometime around the back end of Q3 that we would have approval next year. Obviously, it takes, you know, six months to get reimbursement approval. Fair enough to think about it that way? Well, there's four entry points a year for CMS. Yep. So it depends, you know, the exact timing of the PDUFA. Yep. Obviously, we do get a temporary code, and we can start selling and that pass-through only affects a certain part of the market, but clearly, it's important. And what have you said is the sort of potential market size for that, for that product? Yeah, we've put out, so there's about 150,000 incidental renal masses a year and about 80,000 new diagnoses, and this product would cover all of those. If you factor in the kind of diagnostic utility of the current standard of care, we think it's conservatively about 110,000 patients that we should be able to get as an indication. So the indication would be detection of clear cell renal cell carcinoma, and that would be about the size of the market that we could hope to get. If we are able to expand the indication into a metastatic setting, which will almost certainly require some sort of additional clinical work. Mm-hmm. Whether that's a, a registration study or a post-approval kind of surveillance study or something more formal, we haven't really, we haven't really broached that yet. But expanding into metastatic would mean about another 600,000 patients would benefit from it. So renal cancer starts off fairly small but can grow a lot if we have the clinical data to back it up. We should be thinking about it at a price in line with what you're getting for Illuccix in terms of reimbursement? Yeah, I think Illuccix is probably the floor for that product. It's got a higher pharmacoeconomic benefit than Illuccix, so certainly, the benefit of patient management is really clear case in renal cancer. It is a biologic, so it does have a slightly higher cost of goods, and that will have to be reflected in the pricing of the product as well. Understood. And in terms of your marketing strategy for that product vis-a-vis Illuccix, I mean, how do you get in front of KOLs? Do they know about it? How's that gonna happen? We've had amazing reaction to the product since we presented the phase III data. Ostensibly, it's the same customer base as Illuccix, you know, a sort of comprehensive GU clinical practice. So our sales team is going to be bringing that product really into the same customer base. We started an expanded access program so we actually, I think we have, as of today, approval to proceed, or I think we hit the 30 days yesterday or something. So the EAP is launched in the U.S. We're expecting the first patient in Europe any day now as well. So because we are committed to developing that product for the European market. So we're doing all of the, I think, the pre-commercial and market access things that will generate the awareness and the interest in the asset, you know, prior to commercial launch. And, of course, expanded access is kind of part of the deal with breakthrough designation as well. So, we're, yeah, we're very, really much looking forward to providing early access to that product. And how about getting on the guidelines? Like, the industry's got onto the guidelines with PSMA PET. How about getting on the guidelines with this one? We were very active in the guideline setting process with PSMA, and we feel like we understand the process quite well. And the KOLs that were involved in our clinical trials are very relevant to the guideline committee, so I think there's a high degree of receptiveness. And for us to be able to follow on with all the success of PSMA imaging with something that's so clear-cut and well understood, and everyone understands why we need to have better staging and better patient management in renal cancer. So it's not a difficult sell. Understood. Last question from me because I'm getting the wind-up signal here, but, you know, Illuccix's filings in the, in the EU, I mean. Yeah. Can you give us sort of a timeline around when that might be and when we might see it? So that filing process is very much following the prescribed process. It's a decentralized submission so not a central submission. So what that means, we're using a reference Competent Authority. So we're going through that Q&A process right now with the German Competent Authority, which is our, which is managing all the correspondence on behalf of the other competent authorities. We've got a few months ahead of us of that backwards and forwards and, still on track for an approval hopefully in the first half of next year. Okay. So yeah, there's been no real delay or deviation. It's just a fairly long process, and we had to resubmit, you know, from scratch. Plus, we did choose a different Competent Authority. So I think that, you know, there are a lot of lessons learned from the first time around that hopefully we've applied to the resubmission. Well, good luck with that, and good luck to everyone. We're gonna have to end it there, and thank you everyone very much for the time. Yeah. Thank you, Chris. Thanks.