Good day, and thank you for standing by. Welcome to the Telix Q3 2023 Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Kyahn Williamson, SVP of Investor Relations and Corporate Communications. Please go ahead. Thanks so much, Maggie, and thank you everybody for joining us today. So before we kick off, I'd like to just point out that we've literally just launched an interim readout from our ProstACT SELECT study after receiving the finalized clinical data overnight. So appreciate that people won't have had time to have read through that. We will include some snapshots of that presentation in today's slides. So just firstly, want to introduce the speakers. Joining me today, we have Dr. Christian Behrenbruch, our Group CEO and Managing Director, Dr. Colin Hayward, our Group Chief Commercial Officer, and Darren Smith, our Group Chief Financial Officer. So today, we will take you through the operational and financial highlights for Q3. Chris will talk us through the imaging and technology portfolio, including a commercial update on Illuccix and the development updates across the portfolio. We'll hand over to Colin to speak through the program updates and the snapshot of the ProstACT SELECT data. Darren will finish with financial results and commentary, and then we'll move to Q&A. So just moving... And I'll just mention that the slides are all being simulcast via the webcast if you're following on there, so they'll differ slightly from the ASX release launched yesterday due to the inclusion of the select data. So just moving to Q3 2023 highlights, I really just want to call out some of the key themes for the quarter. It's our fourth consecutive quarter of positive operating cash flow. This is an important milestone in our evolution and maturity as a company. We've had another strong growth quarter for Illuccix, and we continue to feel optimistic about our performance and the growth prospects for this market overall. We have some key value drivers ahead with the filings of our renal and brain cancer imaging agents, and preparation for commercial launch and regulatory filings is well underway. We're making excellent progress right across our industry-leading pipeline. We're obviously really excited today to be able to share with you the snapshot of the ProstACT SELECT clinical readout as well. I think the sum of these parts really reinforce our differentiated position, our different position in the industry and the robustness of our business. Next slide, please. Just touching on the key financial metrics. I won't talk you through the numbers. I'll let Darren do that at the end of the presentation, but I think the key thing here is we've delivered improvement across all of the key financial metrics and continue to deliver a consistently strong performance, cash flow positive, growing cash balance, and growing revenue streams. So with that, I'd like to hand over to Chris to take us through the Illuccix update and the imaging portfolio update. Thank you. Thank you, Kyahn. I'm going to now put a bit of color around the quarter from an Illuccix perspective, as well as a general progress update. Slide 7, please, or to the next slide. So the third quarter saw continued double-digit growth in Illuccix sales and very much a continued positive trend in demand. Revenue in the U.S. is up 13% for the quarter, continuing the trend of market share capture from prior quarters. As we have previously discussed, revenue generally underestimates volume growth because of the growing mix of payers. So for example, government or 340B accounts, and this is really a feature of picking up larger oncology customers from competition. So really very good growth in the quarter. This growth continues to be a mix of some new customer acquisition as well as growth in existing count, existing customer accounts that trust and value the Illuccix product. Going into Q4 and 2024, more generally, we see some positive tailwinds for the business, including guideline development that we believe is starting to push additional growth in procedure volume. We also see continued momentum around patient selection for radiotherapy, particularly as new data is starting to come out, including, I should mention, our own investigational product that Colin Hayward will talk about shortly. I'd like to also specifically mention that there are signs of positive change in the reimbursement landscape for diagnostic radiopharmaceuticals. This is a very active policy area right now in the United States and frankly in other countries, and we are certainly expecting some commentary from CMS next month to indicate where this is going, but you know we see certainly positive direction on that front as well. Moving on to the next slide, please. So I've presented this slide before actually during the last quarterly call, but it takes time for guideline evolution to turn into clinical practice. And we know what we are starting to see is really that increased interest in the field and the use of PSMA imaging for longitudinal assessment. So we really can stand by this market size upgrade as a tailwind not just for Q4, but as we go into 2024. This topic is just getting a lot of airplay at major academic and clinical conferences. So, you know, we see a very bright future for the asset in terms of this, market expansion potential. Moving on to the next slide, please. So just to wrap up where we're going with Illuccix, and I think, you know, the field more generally, mapped out onto the prostate cancer patient journey. So that blue squiggly line is PSA, patient PSA levels. The dark blue bubbles are the current indications we have approved for Illuccix in the U.S. and other jurisdictions. The pink bubbles represent momentum around the guideline-driven use of PSMA imaging in monitoring therapy and disease progression. This is really a longitudinal imaging application.... And then the light blue bubbles represent areas of R&D and clinical data focus for Telix, including utilization of some of the new technologies that Telix is incorporating into the portfolio around AI and applications in early surgical and radiation intervention. I think it's a nice sort of big picture view of just all the opportunities to interact with the patient along that journey. Moving to the next slide, please. This last quarter, we continued to develop and evolve our clinical messaging around Illuccix's differentiation in terms of clinical efficacy, specifically accuracy. This is very much reflecting the guideline evolution that we're starting to see, in the U.S. and in other countries. This messaging continues to resonate with customers, and we think it's even more important as we start to see new competitive entrants into the market that we frankly do not believe meet the necessary level of clinical performance to deliver diagnostic confidence. So you'll continue to see this clinical messaging evolve. You know, we really are following the practice guidelines and the best clinical understanding of these agents. But I think what it does is it really positions Illuccix as the clear front runner from a diagnostic perspective. Moving on to the next slide, please. I mentioned in my earlier comments that you know, we continue to deliver reliably and flexibly to our customer base, and this is a really big part of deepening the relationship with our customers. And so as we start to see, you know, not just other F-18 fluoride F-18 fluorine-based products come to market, but also competing scanner demands from other types of PET imaging, particularly around neurodegeneration and Alzheimer's applications, on the back of CMS's reversal of their non-coverage policy for amyloid imaging. And so, you know, what that means is we're only gonna see more demand for customer scanner utilization, and so providing customer flexibility is gonna be more important than ever. And that's what this chart really shows. So one of the great things about Illuccix is it gives our customers the best flexibility, not only in terms of the time of the day they can have the dose, but the imaging window they have to work with to effectively manage patients in a busy imaging environment. Now, this is partially achieved through the proximity of the pharmacy distribution model, which we've always talked about as being a key differentiation, you know, preparing the radioactive drug product very close to the customer, but also through the flexible dose bracketing that we offer our customers. This results in a far longer imaging window compared to our competition, frankly, an almost three times wider window. This highlights the differentiation in our approach, and the differentiation in our package insert, and really positions our product well and takes the strain out of running a complex patient management environment, in an environment, frankly, that's only getting more complicated. This topic is actually quite hotly debated in the field, but you can't fudge mother nature. A half-life is a half-life. The bottom line is, is that the unique attributes of our product is helping customers to deliver demand in a highly differentiated way. That's your physics lesson for the morning. You know, moving on to the next slide. Just to round out the discussion before handing over to Colin Hayward, Telix's Chief Medical Officer, just a few more high-level updates from me. Firstly, as Kyahn mentioned, we continue to remain on track for commencing the BLA submission for TLX250-CDx, our renal cancer imaging product. This is a huge deliverable for the company, and the team is pushing hard to get it done by year-end, as well as lining up all the commercial manufacturing activity and readiness for launch. The FDA has formally agreed to our rolling submission for the commercial manufacturing data, so that's a real success for the company. Also, we've now launched our expanded access program in a number of countries, including the United States, and this is an important part of delivering on our commitment to patients with unmet medical needs. Although it typically garners less attention from the market, our NDA submission for TLX101-CDx in glioma imaging is also progressing really well. In response to a clinical data review of the agency, we have elected to augment the clinical package slightly, which has delayed submission by a couple of months, but not material to the program, and it's with data that we already have. So we are not gonna be running additional studies to provide that data. In parallel, like for TLX250-CDx, we are launching an early access program that is ready to go. It's been filed. It's just pending regulatory approval. So plenty of momentum with this program and lots of opportunities to engage with key opinion leaders for these two programs over the next few months. Finally, in the earlier prostate cancer journey slide, slide 8, I think it was, in the released investor presentation, I mentioned that new technology is an important part of, or we believe is an important part of driving the utility of our diagnostic platform, not just for Illuccix, but for all of the future assets in the company. We've made excellent progress with our activity around AI and clinical decision support that is expected to benefit all of Telix's imaging agents as they become approved, and we are already preparing to file our first regulatory approval before Christmas, that's this year, for an Illuccix-related, AI application. So our regulatory team is certainly very busy at the moment. Similarly, the completion of the Lightpoint acquisition from the business development team is expected to take place by end month, opening the door to a whole raft of new applications for Illuccix and other Telix imaging products in the operating theater. In the near term, it's about building depth of relationship and offering to urology, but in the longer term, we can see the utility of this intraoperative guidance technology in many different surgical settings. This is really neat technology, and we're looking forward to expanding its capability under the Telix roof. So 2023 has been a big year leap forward and for the company, both commercially and technologically. I see Darren's gonna spell out the commercial pieces in a minute from a finance perspective and a Q3 results perspective. We are looking forward to commercially progressing many new products in many new jurisdictions in 2024. I'll now hand over to Colin Hayward to give you a clinical overview, as well as cover off on our late-breaking ProstACT SELECT data that's come in overnight. Take it away, Colin. Great. Thanks very much, Chris. And, yeah, it's very nice to go before finance for a change, so thank you. So, let's go on to the next slide, ProstACT SELECT study. Well, just to remind you of the study purpose. Really, it's about comparing that biodistribution for the small molecule PSMA imaging agents to our antibody, our first-in-class antibody therapy, and this is really critical for patient selection. It's also about reinforcing the tolerability profile and understanding that a little bit more, as well as capturing some activity data. Although, of course, this is not an efficacy or a control study, we continue to monitor patients in the study to generate that activity. If we go to the next slide, please. What are the key findings? Well, the objectives are met, really demonstrating the safety profile of those two doses in that patient-friendly regimen, which is two doses apart. And of course, showing that there's uptake concordance with the small molecule as well, and that those, the clear dosimetry of the product, which I'll go into more detail. But really the key thing is that retention of the activity. We do have some preliminary activity in those patients, who had a baseline PSA and had the full dose, with PSA reductions seen in over half the patients. And there's still a large number of patients in follow-up, so we're continuing to monitor that radiographic progression-free survival. So if we go to the next slide. Clearly, beta emitters in patients who have much better marrow reserves, like this patient population, that is the patient population reflective of ProstACT GLOBAL. We can see that the hematological profile, those adverse events as Grade 3 and Grade 4 adverse events, are much lower than we saw with earlier studies. Why is that? That's really because those earlier studies were performed in patients who were much more advanced disease. So really, 25% of patients had a Grade 4 thrombocytopenia, which was also recovering as well. And if we go to the next slide, you can see here some comparative dosimetry. Obviously, these are in separate studies, but what this does for me is really illustrate the point of where an antibody uptake is versus a small molecule, and we can see there's much less exposure of the antibody, in particular in the kidneys and the salivary glands. If we go to the next slide, I just wanna summarize that, you know, clearly this is a study, it's a snapshot of the data so far. We're continuing to follow up those patients. We see lower rates of toxicity, and this really sets the scene for us to move forward, and continue with the ProstACT GLOBAL study. We opened those sites for enrollment, and expanding into international sites early next year. The next slide is a slide that you're more than familiar with. It shows the depth of our pipeline, particularly across the GU oncology space, but also progressing in GBM and in bone marrow conditioning. And if we go to the next slide, this shows our research pipeline with different combinations, different isotopes, and different molecules, all being prepared to be advanced, to become moved to our late-stage pipeline in the future. If we go to our last slide, my last slide, in terms of the core pipeline development highlights, I really want to highlight the progress in some of our therapeutic studies. CAIX program, really the first patient cohort being assessed for safety now in the STARSTRUCK study. That's the lutetium girentuximab in combination with pembrolizumab. The STARLITE studies, the combinations, with the therapeutic girentuximab, together with immune oncology agents continuing to progress. And as Chris mentioned, the TLX250-CDx EAP is open, and starting to take off really for zirconium girentuximab. If we look at the prostate cancer therapy, we talked about SELECT, and then also ProstACT GLOBAL in APAC is active, and expected to open into US sites in quarter one, 2024. And meanwhile, in brain, the IPAX-2, the first patient cohort, has been dosed, and again, we're at that point assessing for efficacy so we can progress rapidly to the next, dosing cohort. And the IPAX-Linz, which is really a follow-on to that original IPAX study in a recurrent population, is gonna be generating some interesting information, in that recurrent GBM. Other things at near-term horizon, really 101-CDx expanded access program as we prepare for the NDA as well, and then think about label indicating studies to follow on from IPAX-2. And of course, in our rare disease programs, looking to start the radiolabeled elotuzumab, TLX300 in sarcoma patients, pending ethics approval, as well as TLX66, the, yttrium besilesomab in patients with AML. We're also awaiting our first dose of investigator study in the UK of this agent in pediatric leukemia. So I think, I think that shows, you know, just with a snapshot from SELECT today, but also the clear progress across the board, yes, imaging, but also, clearly in our therapeutic programs, across all of those key areas. And with that, I will hand over to Darren to talk about the finance. Thank you, Colin. I'm now turning to slide 23 in the financial commentary. I'm very pleased today to be on the call to present Telix's quarter 3 4C financials, as it represents a major milestone in the company's maturation by achieving its fourth quarter of consecutive positive operating cash flow. This delivers on our stated financial goals of establishing a sustainable commercial enterprise that is capable of funding its development of its own industry-leading pipeline. Cash on hand continued to increase, ending the quarter at AUD 137.4 million. This is a AUD 5.7 million increase on the prior quarter. Operating cash generation this quarter was a very respectable AUD 21.4 million. This is a AUD 10.4 million improvement over the prior quarter. As previously reported, strong revenue growth and a focus on managing and controlling working capital has delivered on this fourth quarter of positive cash. More specifically, and as displayed in the graph on the bottom right of this slide, customer receipts improved $18.5 million to $130.7 million. This is a 16% improvement over the prior quarter, and was driven by continued revenue growth and improved customer collections. These cash inflows funded and more than covered increases in our cost of goods sold due to the increased sales volumes. It also covered off the increases in our investment into progressing Telix's late-stage assets towards delivering two new revenue streams next year. And it also met the requirements of our first annual contingent consideration payment of $17.8 million for the first twelve months of commercial sales of Illuccix. Now turning to slide 24. During the last quarter, revenue continued to grow on the back of average daily demand of Illuccix increasing month-on-month. This was achieved through the acquisition of new accounts and improving volumes through existing customer sites. Illuccix percentage growth margin remained consistent with previous quarters. This reflects stable selling prices within market segments and good control and stability of materials, manufacturing, and supply chain costs. Commercial operating expenditure was consistent with previous quarters at 25% of sales. It's worth noting that this investment includes a focus on continuing to support and drive the growth of the global Illuccix franchise by pursuing new marketing authorizations for Illuccix in UK, Europe, Brazil, and selected countries in Asia Pacific. It also included the commencement of preparing the market for Telix's two new revenue streams and ensuring that the business's infrastructure is scalable for the future growth. Telix's pipeline investment continued the plan, with a majority of the investment advancing the U.S. regulatory filings for our renal cancer and brain cancer imaging diagnostics, including their manufacturing scale-up, and also the commencement of the ProstACT Global Study. Now turning to slide 25. Telix's financial performance in terms of global revenue and EBITDA has improved every quarter since the commencement of the commercial sales in April 2022. This quarter is no different, with 11% growth quarter-on-quarter in both global revenue to AUD 133.6 million, and the adjusted EBITDA to AUD 50.6 million. It is worth noting that this quarter's revenue annualizes to AUD 535 million. This is a great achievement to be delivered in 18 months from a standing start. This growth, in turn, has delivered 4 consecutive quarters of positive and growing operating cash flow, which permits us to pursue our strategic objectives. Telix remains focused on contributing, on continuing this trajectory by continuing to grow its global Illuccix business through geographic and indication expansion, to investing in advancing the U.S. regulatory filings and commercial launch preparations of our renal cancer and brain cancer imaging agents. And, and finally progressing our therapeutic pipeline and commencing our ProstACT global study in the U.S. I'll now hand you back to Chris to, to round out with our outlook and upcoming milestones. Thanks, Dan. Great summary, and as you noted, very, very satisfying to have both achieved the milestone of 4 consecutive quarters of positive cash flow, as well as $500 million in annualized sales for Illuccix or well over that. So, yeah, great, great, great financial momentum. So moving to slide 27, the final slide in the deck. Just to conclude this presentation with an umbrella view of the business, we continue to achieve tremendous goals and are on track to meet our corporate objectives for 2023. We still have some important data readouts and clinical milestones between now and the end of the year, as Colin has alluded earlier. Aside from the new product filings, which I've already covered off, the big focus is on ramping up ProstACT GLOBAL and expanding the current APAC recruitment to include the US and Europe. We are making very good progress on this, and the really very encouraging data from ProstACT SELECT that Colin quickly went through, and I encourage you to look at the full presentation that's been lodged with the ASX this morning, as well as recent commercial activity in the market around PSMA therapeutics more broadly. It reminds us that this is a vibrant and high-value opportunity that Telix has in sight. It's very motivating. Just to mention, because I do get asked periodically, our regulatory submissions for Illuccix in other countries continue to progress in line with expectation. Brazil approval has taken a bit longer because of scheduling manufacturing site inspections with our manufacturing partner in Brazil, but otherwise, European approval is progressing as expected. We had a very useful consultation with the Japanese PMDA this quarter, as outlined in the 4C. That sets a stage for potential filing next year, as well as continued recruitment progress in our Chinese phase III bridging study with Grand Pharma. So really progress on all fronts. I'll now on that note, open it up to questions and comments from analysts. Thank you. Thank you. We will now conduct the audio Q&A session. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by as we compile the Q&A roster now. Our first question comes from Shane Storey from Wilsons Advisory. Please go ahead. Good morning, everyone. I might start with Colin, please, and the Select data. The first question there is... Look, our first impression here is that the PSA responses and the higher grade AEs both look a little bit lower than what we've seen in previous studies. So, Colin, I wondered if you could tell us, are there any significant differences in the patient population there that we should have in mind? And then maybe as a follow-up, conceptually, do you think you could possibly dose higher than the, I think, the 76 millicuries that you're currently using? Thanks. Yeah, thanks, Shane. Look, it's, you know, this is a data snapshot. We've certainly seen. You asked about the significance. We haven't done statistics on these, but clearly, the AE profile looks a lot more encouraging. I think this is reflective of the second line metastatic population of patients group with much better marrow reserve than before, you know, than the earlier studies in patients who were very advanced. I think what we need to do is continue to follow up the patients. There's still a number of patients in follow-up, and we've seen some later PSA responses, so we need to understand the efficacy and how that might relate to dose. Approximately, the dose is a 45 millicurie per m² dose given as a set free. I think we need to see, you know, the final activity data going forward. Yeah, thanks. Can I, can I, Shane, just before you go on, can I, can I just chime in? I mean, you have to go back to the phase II trial data and remember that those were pre-palliative patients. I mean, those were very, those were super heavily pretreated patients that had very little, very little hematologic capacity. So now we're, we're treating patients in a much more, a much earlier setting, and just like we've seen in the recent, Pluvicto results that came out in advance at ESMO, you know, healthier patients are result, resulting in fewer AEs. And, and I would go so far as to say that although it's a relatively small data set, you know, it's, it's 30 patients enrolled, 28 patients counted. From a safety data set perspective, it's still a good size, data set, and it's a fixed dose. It's not a dose escalation. So what you're seeing is a competitive AE profile to, to other agents in that setting. Oh, absolutely. So, you know, we think that Select goes a good way towards dispelling this issue of toxicity, and in fact, when you look at the comparative biodistribution, you can see just how much more targeted the antibody-based approach is. And then, you know, the other thing regarding PSA, you know, we've always said, and it's pretty well documented out there, in the public domain, that doing a comparative PSA profile between a small molecule and a biologic, isn't gonna be straightforward. The reason why we put out three case studies showing very different levels of disease burden and that biodistribution element that was part of the study is it just shows you how late some of those PSA nadirs are, like a year, a year before you hit rock bottom on PSA. So, we're gonna have to have, as we go through and and not only read out this study in terms of PSA and PFS, but as we go full throttle into global, how we monitor PSA in a longer window, it's gonna be really important for this agent. Yeah, I was going to ask you, actually, you know, mechanistically, it seems early... I mean, the early data from both small molecule and antibody, if you put it together, I mean, it seems to be suggesting, you know, that an antibody-mediated sort of therapy tends to have, I guess, more modest PSA responses initially, but then longer survival. So mechanistically, I, I was going to ask you to help explain that and reconcile that for us. Well, it's just because of the retention of the agent. So, you know, if you compare re-internalization, retention, and excretion of lutetium, the lutetium just hangs around a lot longer, and that, that has a very different radiation biology profile in turn than the small molecules do. And that's why we're seeing some of these incredibly long and slow PSA drops. And, you know, and that's just, that's just something that you don't generally see in small molecules, and that's the reason why the dosing regimen for small molecules tends to be 6-8 weeks apart, as a way of kind of throttling that treatment.... Whereas, you know, our strategy is about a very deep and aggressive treatment on the front end that we hope and, of course, we've now got to show it in a randomized study. You know, that you know we think is gonna potentially lead towards a more durable response in patients. And just the fact that we are tracking PSA nadirs out to a year, I mean, I think it's gonna be very exciting when we do actually have the PFS data for this agent, because we will read out PFS for this study. I imagine it'll come in sometime in the new year, early in the new year. But it's a little hard to predict just because some of these patients have been hanging around for a long time. Mm-hmm. Understood. And then finally from me, and you mentioned the Pluvicto pre-chemo result in the last few days. I'm conscious that the full data hasn't been released yet. But did that change your thinking or any in terms of how you may sort of seek to tweak the protocol, heading into ProstACT GLOBAL, IND filing later this year? I'm actually gonna let Colin, and this is really Colin's wheelhouse, except to say that we will be talking more about... There has been some amendments made to ProstACT GLOBAL. Okay. We, you know, despite the fact that the readouts are new, you know, the protocol is not. So we have certainly taken into account SPLASH and PSMAfore. Maybe, Colin, do you want to talk about kind of real-world standard of care? Yeah, yeah, for sure. I think there's been a lot of criticism about a number of prostate cancer studies where they've compared to the next generation of ARPI. So, you know, a second abiraterone, followed by enzalutamide, for example, on progression. So what we wanted to do is... And again, having a patient-friendly two doses, really gives us the opportunity to add on to additional therapy. And so what we want to do is really open up to existing true standard of care and allow the sites to define what that would be, within reason, through the two most common standards of care, which would be a second level hormonal therapy or androgen receptor antagonist or docetaxel as well. So really we want to open it up to patients who would be potentially receiving taxane as well. I think that's a key thing so that we're really reflecting true standards of care out there. That's all my questions. Thanks for your help. Thank you. Thanks, Shane. Just a moment for our next question. Next, we have David Stanton from Jefferies. Please go ahead. Morning, team, and thanks very much for taking my questions. Just two from me. I note some following up Shane's question, that those 4 patients or 17% received intervention for hematological toxicity in the ProstACT SELECT trial. I wonder if you could explain that compared to what you would expect to see in terms of, you know, in an intervention percentage that would require an intervention in terms of standard of care, chemotherapy only. So if we could compare, you know, what standard of care chemo only would look like, compared to what you've done in the ProstACT SELECT trial, that'd be great. Colin, you want to open up with that, and then maybe I'll chuck a couple of comments on the end? Yeah, sure. Look, I think, you know, clearly this is not a controlled study. I think we'll be able to actually get that much more from the PSMA-4 data as it comes out and understand what the true toxicities in both arms are. We've seen, you know, serious adverse events in that study, 20%-30% in the arms, respectively. Clearly, docetaxel is associated with hematological toxicities. That will be one of the comparators. So I think I would just say at this stage, it's a lot less than we've seen in prior studies, because these patients have better marrow reserve than our earlier studies, for sure. And we'll know more when we've got a proper controlled study. Yeah, I think that's a good answer. I also think that the, I mean, the tox comparison from the ESMO abstract is out there. And what you'll see is what's been classified as a serious AE, which we interpret to be a grade four, looks fairly comparable to what we've seen in this study. Admittedly, noting that this is a smaller study, but still, from a safety study perspective, it's a reasonable number of patients at a single dose. And then also, they have published the comparator arm, the control arm data, and as Colin has noted, you know, there is toxicity in that control arm. So I think, you know, again, the overall message, and indeed, it's a message that's coming out very loud in the field overall, is that as we move PSMA therapies into earlier line patients, you know, toxicity is something that's better managed. And so- Mm-hmm. ... it's really about a race around durability. And, you know, we've always said that. I mean, David, as you know, because you've been at the forefront of asking these questions, you know, I've been saying for two years now, which in fact, one of the exciting reasons why we decided to do this SELECT study, as well as getting that, you know, that radiogenomic data, which we need for patient selection, is to really have a safety data set there with the dosing schedule that we expect to use for ProstACT GLOBAL, and to be able to show that when you move into patients that are not on their last breath, which is really where the historical studies were done, you actually have a very different safety profile. ...Understood. Thank you. And my, and my second question is, is for Darren, if I may. I note that, you know, you've, you've, had a R&D spend of, call it, close to, eighty-four million bucks i- this, this financial. You know, what, what should we be thinking, for, for the full year? Should we be thinking, you know, the, the third quarter number again into the, into the fourth quarter in terms of an R&D spend, so around that thirty-four million number, please? Yes. Thanks, David. I think one of the things maybe it is footnoted within the presentation, but just to make clear, is that there is expenditure going on that relates to the scale-up of the manufacturing. So it's not just purely R&D. So, you know, we've kind of captured a number of things under that big bucket. But obviously it does reflect the preparation for delivering those two new revenue streams. So R&D, purely, definitely still will remain on plan with the requirement for us to get ready for the manufacturing of commercial product pending the approval of those two new diagnostic assets. I'm sorry, I didn't quite follow that. So are you saying that you're sticking to the $100 million or it's gonna be more than that? It's as bold a question as I can make it. R&D will be to plan, which is around that AUD 100-AUD 105 mark, which we've talked about before. In addition to that, there'll be some expenditure that's reflective of getting commercial manufacturing ready for... That'll be within that bucket as well, as we describe it. Understood. Thank you. Just a moment for our next question, please. Next, we have Dennis Hulme from Taylor Collison. Please go ahead. Good morning, and thanks for taking my question. Just firstly, in relation to the ProstACT SELECT data, where we saw lower hematological tox in the phase II, you were asked previously about maybe increasing the dose. I was also interested to know, are you contemplated putting in additional cycles of treatment, perhaps into the ProstACT GLOBAL trial? Colin, do you wanna open with that? Sure. Look, I'd want to see the final activity data, but, you know, there's I think the data that we have generated, the overall survival that was done in the early studies, that was over 40 months, was with a similar dosing regimen of the two doses, two but doses apart. and so that is the dose proposed into the ProstACT GLOBAL study right now. It's the dose that's active in the study. So, you know, Dennis, we don't plan to change the dosing regimen. In fact, for the last two or three years, mostly we've had commentary that maybe we ought to consider lowering the dose because there wasn't necessarily the confidence that when we moved into earlier stage patients, that the toxicity profile would be any better. So I think we don't plan to change the dose. There's always possibility of making additional doses available to patients as an optional study protocol, but at the moment, you know, we really see great commercial value in keeping the dose regimen short from a trial perspective. We think that's what the market really wants. We think that's what patients want. Fewer hospital visits, shorter period of treatment, and much more flexibility given back to the medical oncologist to look at the range of other therapies that are out there. And I think sometimes in the radiopharmaceutical world, we get a little bit myopic and, you know, we think that everything stops and ends with nuclear medicine, but there's a whole vibrant field of drug development in prostate cancer right now. And by integrating radiopharmaceuticals into medical oncology, the way that we are proposing to do, that's gonna give the patient the biggest number of options. So I think we're pretty satisfied with the protocol that we have. Okay, thank you. So my second question is just on the CUPID trial of TLX592. You've mentioned in the presentation that dosings commenced in the final cohort, hope to fully enroll this quarter. I was just interested when we would expect to see results from the CUPID trial, and just to check with that cohort, are they being treated with the therapeutic, or is this still the imaging component of the trial? That is recruiting into the final cohort right now. These are patients with bulkier disease than the early cohort. The only thing we can say right now is it's, you know, it's extremely well tolerated. They are being treated with the copper version, the copper, TLX592. That will give us an understanding of the dosimetry of the biodistribution. Then once we've recruited, if we've recruited, you know, this quarter, then early next year, we'll be able to provide an update. Okay. So this is on the dosimetry. They aren't actually undergoing alpha therapy in this cohort? Not in this cohort right now, no. ... Yeah, and Dennis, I think there's been some confusion around that. So just to be clear, we are not commercially developing a copper agent. That's just as a proxy for actinium, because we can't detect actinium straightforwardly in a scanner that's gonna give us dosimetry. So once we have that dosimetry, and we've, this study enables us to set the mass dose, and set the radiological dose for the agent, then that enables us to then safely switch the study over to actinium therapy. Right. Okay. Thanks very much. That's all from me. Yep. Thank you. There's no further audio questions. I will pass on to Kyahn for web questions. Thanks, Maggie. Just have a couple of questions. The first is: Do you think your submission timeline for TLX250-CDx will allow you to meet the deadline to receive October 2024 pass-through? It's a bit tough to answer that question right now because we don't have a PDUFA goal date. But, you know, we are, we're obviously hopeful that the breakthrough designation, which will entitle us to a priority review, would get us pretty close to that, that date. But I think until we have a, a PDUFA date, finalized, it's gonna be, it's gonna be hard to say. So that will all fall into place pretty quickly once our BLA submission's started. Thank you. We just have time for one more question, and that question is for Darren. Is the contingent consideration a fixed annual fee from now on, and should it be considered as an operating expense? Interesting question. It's a bit of an accounting question. Basically, as we spoke about before, the contingent consideration relates to Illuccix sales, and it's an earn-out on the acquisition of that technology back in 2017. So it is based on a percentage. So obviously, if you take the first 12 months of sales, there's a bit of a formula on how it's calculated, but an effective rate, you can just put what we've paid out for those first 12 months over the top of those first 12 months of sales, and that'll give you an effective rate. So that would continue on from a payment perspective. Whether it goes into the P&L, the issue is it's already been accounted for. So you'll note within the balance sheet, there is a contingent consideration liability that reflects what we'll need to pay over the lifetime of that agreement. So that's where we draw down the cash from. So it doesn't actually hit the P&L unless we change our forecast for what we expect that will be generated over the next number of years from Illuccix sales. So hopefully that kinda covers that off. Yeah, I mean, I don't think it really matters. I mean, I think at the end of the day, the revisiting of that contingent payment is just a function of commercial success. Correct. And if we don't have the commercial success, then we don't pay it. If we do, we do. Of course, just to remind everybody, and we discussed it in the past, we also do have a cap on that earn-out, so which we've met the preconditions for, to cap that liability. So I think we have a pretty good handle on the forecast right now, and I think that contingent consideration is well understood and consistently documented now. Kai, do we have any other questions from web? No, we don't. So with that, we can, we've come to the end of allotted time, so we can close. So thank you very much for joining us today. Please do take a look at the more extensive select documents that are on the ASX, and thank you for your participation and questions. Thanks very much. Thank you. This concludes today's conference call. Thank you all for participating. You may now disconnect.