Very much, for coming down to join us here for our conference. Perhaps just to kick us off, could you start off with some brief background on your company platform and pipeline? Sure, definitely. Thank you very much for the invite to meet today. POINT Biopharma is a precision oncology company. We're focused on radioligands. I would say, when you think of a radioligand, what we're doing is utilizing a molecule, seeks out a certain biomarker on cancer cells and delivers a radioactive payload, a therapeutic radioactive payload. This space and actually the use of radioisotopes to treat cancer has been known to be safe and effective for over 50 years. You might ask, you know, "Why aren't more doing this?" Well, there's been this real perceived complexity around supply chain and logistics that have held a lot of people out of this space. We see that as making it an incredibly untapped, and kind of unresearched or utilized area in the treatment of cancer. What POINT has done is we've actually built a platform to address these complexities, to allow for these drugs to overcome those logistical hurdles. With that platform now in place, we're leveraging that for clinical development, both on late-stage assets, which we'll talk about in a little bit, but then also bringing forward new ligands or new RLTs or radioligands into the clinic, to continue to advance this. Again, very, very large greenfield in this space that we're looking to take advantage of. Great. You know, if we could touch upon, you know, maybe some recent corporate developments. You had recently signed a deal with Lantheus. The investor reaction was what it was. Perhaps, you know, could you perhaps give us, you know, some of the key highlights and also perhaps, you know, what might investors be missing with respect to the value for POINT from that deal? Yeah, definitely. Lantheus, for those who don't know, is a leading nuclear medicine company. They have a track record of 65 years of success in this space. They are currently leading the prostate cancer imaging space with their PSMA targeted PYLARIFY product. When we looked at them as a partner, we saw them as being better suited given that they're already in the community, speaking with prescribers, and educating on PSMA targeting, and they're better suited to really advance this and get the most out of the asset than POINT is. You know, from a value add here, we have to look at this in a couple of ways. It really offsets that execution and commercial risk that POINT would've taken on with the amount of capital we would've had to raise to build that sales force. We offset that. We still see that we get a significant amount of the revenues, and we take a very healthy share of that, which is positions POINT quite well for our future endeavors. It allows us to bring revenue forward, and we can now deploy that capital into the early part of our program, really bringing forward novel radioligands against novel targets in the space. The other point I should mention is the deal, just looking at milestone payments is about $1.8 billion. That's plus royalties and what we see is a very robust manufacturing margin. Can you also talk a little bit about that manufacturing revenue and perhaps how we should be thinking of that, you know, maybe as an amount or potentially as a% of net sales? It's perhaps not something we're used to seeing here. Mm-hmm. Yeah. We haven't disclosed any details on that just because we feel that that would give others a competitive advantage. We're keeping that to ourselves. Other than thinking about this is we've built a very unique skill set in manufacturing. The nice thing about this deal is we retain that. POINT is going to be manufacturing for Lantheus, but we retain all of those investments in isotope in the facility to be able to deploy to our other products. In doing so, and having a very unique position in this space, none of our competitors have the infrastructure that we have today. In those negotiations with Lantheus have really put us in a good spot to ensure that that becomes a profitable business unit within POINT. Great. Given that, you know, you've executed this deal on the business development side, and it sounds like you have, you know, a lot more capability now to reinvest into your early pipeline, you know, along with a long cash runway. How are you guys thinking about, you know, future business development deals and what those could potentially look like? Yeah. It this does provide us with even before we hit the regulatory milestones with cash that takes us into 2026, and then once you bring into those milestones cash where we won't be looking for any capital raising in the, in the medium term. As we look at taking that cash and kinda investing that, we're looking at a few areas. One is bringing forward new radioisotopes. You know, that's a specialty that we have in understanding these and making strategic investments, and capabilities. Looking at licensing, either in-licensing, specific molecules could be turned into radiopharmaceuticals or looking at licensing and platforms that we could then leverage to go after different targets, as well as building those out internally. We do have some target or some platforms that we've already brought in-house, such as our FAP-targeting platform, such as our CanSEEK prodrug platform, that we'll be investing in. A lot of kind of organic in-house development, but as well, we're looking at opportunities both from other isotopes that we can make strategic investments in that will, you know, further solidify our pipeline, as well other assets that we could partner on or potentially in license. Great. Great. Perhaps I want to transition now over to PNT2002. Mm-hmm. Perhaps one of the central parts of the Lantheus deal, but this asset is heading towards a phase III readout later this year. How are you guys thinking about the setup for your molecule as well as potential competitive positioning relative to Novartis' Pluvicto? Sure, yeah. Just to talk a little bit more about the phase III trial that's running, it's called SPLASH, and it's positioned in for prostate cancer patients that have failed the ARPI, so enzalutamide or abiraterone, where they're chemo adverse or chemo ineligible. Their only option is actually the switch. If they came in on enzalutamide, they'd switch to abiraterone or vice versa. The trial's designed in a 2:1 randomization, where patients either go on our treatment or they get switched to the other ARPI. When we look at this in comparison to what the Pluvicto is doing, the trials are very similarly designed. The consensus around here, around this is that actually the molecules perform very similarly from an efficacy standpoint. Where you start to see some differences, and we see advantages here, is, we're only treating patients 4 x, in the Pluvicto label, you're treating patients 6 x. We give patients more recovery between doses, and we feel that that's really gonna play out quite nicely as patients, the experience that they go through in the treatment with these drugs. Other additional pieces in there is, you know, we've really built out a robust supply chain. That was one of the first investments POINT made was in supply chain. We feel that the delivery of these drugs and the logistics behind this are really gonna drive success commercially. We feel that investment there, along with what we see as a very similar efficacy profile, will really drive our ability to compete in the space and help Lantheus lead in the space. Great. I guess, you know, one point of investor pushback that we often get, on the clinical, you know, potential clinical side of this is that, you know, these radioligands do look somewhat similar, but, you know, Pluvicto can dose up to 44 GBq. Mm-hmm. You guys dose up to 27.2, I believe. you know, how similar or different do you think, you know, efficacy and perhaps as well as safety could be? If you look through the literature, you'll see that the first two to three doses are where you get the most impact. A lot of those studies were actually done in patients that had a lot more tumor burden than you have in this current patient population. When we look at our lead-in study of 27 patients, actually only 10 patients came in with evaluable disease. You're dealing with patients with a lower tumor burden. Therefore, we feel that the four doses is actually adequate in order to get the efficacy. Where we see an advantage is those extra two doses that you're, you'd be looking at with Pluvicto are actually just leading to toxicity. You're getting the benefit of the drug in the first four doses with POINT, you're not actually carrying forward into those next two doses, where we believe you're gonna start seeing the toxicity manifest. Overall, a higher amount of dose being given with Pluvicto, we don't feel that that's needed. We feel that actually this will be more attractive to get lower exposure to the radioactive molecule, fewer doses, fewer visits, and greater time for recovery between treatments. If you go back into the academic literature, these treatments were actually being used down around 5 GBq and typically at an eight-week interval and up to maybe three doses on average. This switch to your six cycles, 7.4 GBq every six weeks, is not necessarily been driven out of that, dose-finding kind of clinical efficacy, rationale. Got it. Great. Perhaps one incremental piece of news that recently came out of Novartis' earnings call was that it sounds like they refined, you know, guidance on timing for PSMAfore a filing- Mm-hmm. because they needed more follow-up, you know, for a, you know, FDA asked for a look into overall survival. We already know that the trial succeeded based off- Mm-hmm. ... of radiographic progression-free survival. You know, from that perspective, you know, does that potentially impact or affect what you may need to demonstrate to the FDA in order to get regulatory approval and how should we think about that from a timing perspective? Back in 2020, when we started our engagement with the FDA on our SPLASH trial, we had very detailed discussions on statistics. We actually had the advantage that they've raised this with us back then, that when we do our top line analysis on our PFS, which is the primary endpoint of our trial, is that we do actually look at an OS trend. The direction that Novartis has just given, that they have to look for that OS trend, we had already built that into our trial. That's not gonna be a surprise to us as we announce top-line data. Very exciting to see that they had a positive trial. Unfortunate that now they have a delay in their filing, but that was something that we had already gotten ahead of. Great. Can you also perhaps talk a little bit about how these patients are identified for PSMA positivity and, you know, also kind of related to Lantheus, given that you're partnered with them, what sort of a commercial synergies that PNT2002 could potentially capture. Mm-hmm. ... by PYLARIFY? Yeah, very good point. For patients to get on the trial, they have to scan positive with a PSMA imaging agent. PYLARIFY being the one that Lantheus has. They'll scan positive, and about 80% of patients that do get scanned are scanned positive for the treatment of the drug. A high percentage of patients actually get on the drug. Lantheus is in a great position, you know, being that they're leading the space by far in access to PYLARIFY. That synergy between, you know, their communications and education around PSMA imaging will tie in very nicely. They've been a very close partner to POINT. As we've gone through this trial, they were able to get their supply up and running so we could get patients onto the trial. We've been kind of marching forward hand in hand. While their supply comes online, we can open up clinical centers. The tie between PNT2002 and PYLARIFY has been there kind of since the beginning, which is nice. Obviously the gallium agent has come on a little bit later. Our drug does allow for both the gallium and the F18 agent. In areas where patients can have access to the F18, which there are still areas in the U.S., there is no barrier to patients getting on here. Very clearly, given the footprint that Lantheus has, given the connections that Lantheus has, this is a very nice synergy between their PYLARIFY product tied and their positivity on that tied to the use of PNT2002. Great. Maybe one more on PNT2002 before we move on to other assets, but, also on Novartis' most recent earnings call. I think it's fair to say that they had smashed Pluvicto sales relative to consensus. I guess, you know, on one hand, that's great that the market opportunity is larger, but how are you also thinking about that from a manufacturing capacity relative to that patient demand? Yeah, it was amazing to see the numbers that came in, they could be much larger than that. You know, right now, Novartis is supplying out of a site in Italy, one site that's really supplying all of the U.S. market. That creates logistical challenges because you have that transit time, which impacts. You know, these drugs have a fixed shelf life of about 5 days to be used in. All of that's gonna impact the availability of the drug, and the fact that they were able to knock out of the park, their numbers and exceed the analyst consensus, I think is great. Unfortunately, we're not seeing the true potential here because of that kind of miss on the manufacturing side. What we're really happy about seeing here is that there's enough treatment sites now. That was the one piece we were worried about, is that that last mile where the patients were treated, that there'd be limitations there, or there would limit access. We're not seeing that. Right now, the limitation to these drugs reaching their potential we're seeing is logistics and supply chain. That was where POINT put investments in, right out of the gates when we started as a company. We have our facility in Indianapolis. It's running. It's manufacturing batches currently at a commercial scale. That's only getting ramped up as we move towards potential launch in 2025. We've already planned for this and built for this. Seeing this success here, it's kind of validating the amount of investment that we put in there, both in isotope supply chain, which is a key part of this. De-risking that isotope supply chain by having multiple vendors, including in-house supply from a POINT's own lutetium production, tied to very robust investments into manufacturing at scale that will service this market even at the numbers that now analysts are pointing to. We had that insights early on. We knew that logistics will, you know, come through and drive success in the space so that we've been validated in all those early investments. Great. Great. I do wanna move over to some of your early pipeline assets, perhaps starting off with PNT2004- Mm-hmm. ... fibroblast activation protein. I guess, what makes FAP an interesting target, and how are you perhaps, what's your progress in the clinic, and how are you setting expectations for clinical data? Sure. Fibroblast activation protein is expressed in greater than 90% of epithelial tumors, so it really offers. By targeting, it offers kind of a pan-cancer asset. We see our PNT2004 program as kind of a pipeline and a product. That means that we have, you know, monotherapy opportunities across a variety of tumors. We have combination opportunities, and, you know, really, anything we wanna look at there from how to advance this program. We have to get through phase I, of course. We are in our safety dose escalation. We've gotten through our first cohort, which is at 8 GBq. Just for reference, for those who aren't familiar with the dosing levels here, the prostate cancer drugs, ours is being treated at 6.8 GBq. 4 GBq is actually pretty close to the therapeutic range. We're done that cohort. We've seen that is safe. We've now moved into the second cohort, which is at 8 GBq. We're gonna actually move up. If that's safe, we'll move up to 12 GBq. We're now getting into ranges that are currently not seen with radiopharmaceuticals. The reason for that is typically the off target. Our molecule was very clean in the preclinical studies, not hitting bone marrow, not hitting kidneys. All those at-risk organs are not an issue for us, which has allowed us to convince the regulators to, as long as we pass a certain safety criteria, to go up to 12 GBq. That's really exciting for us. Right now we're looking at that in colorectal melanoma, pancreatic, esophageal, and soft tissue sarcomas. That's operating currently in three sites in Canada. It's gonna move into two sites in the U.S. We expect to be into phase II studies in 2024, and that's really where we're gonna have to make those choices, is where are we gonna go from monotherapy, where are we gonna go where we can have interesting combination studies. We have published in our deck, a combination with PD1, which looks very impressive in a CT26 model. We're bringing it forward from some combinations with chemotherapy as well. The key data that's gonna come out of this trial, that we'll look to release in the early part of 2024 is actually dosimetry. The nice thing about radiopharmaceuticals is you can actually image them, see how much dose gets into not only the tumor, but into healthy tissue, which allows you to kind of project what your dosing could look like in phase IIs and how you can take that approach there. We'll be publishing that in the early part of 2024. That will inform how we're gonna move into our phase II studies. Just how de-risking is dosimetry, especially, let's say, on tumor dosimetry, and how translatable is that to something like a RECIST response? Yeah, very good question. I think what we know from external beam is ranges of of total gray that would need to be absorbed. Of course, that has to do with the volume of the tumor, and there are also many other aspects of that. You can, you can make some assumptions based on what you're seeing in that total deposited dose on what the potential impact from a RECIST per-perspective is. This whole field's still in its infancy from a dosimetry standpoint, so we're still learning as we go through this. There are learnings from external beam that you can start applying here. Once you get a certain amount of deposited dose, a lot of calculations go into that. You can start making assumptions on, you know, how often will we have to treat to get that amount of total deposited dose in the tumor? Can we treat that frequency based on the toxicity that we have? That goes into your phase II-type design. A very rich set of data comes out of these phase I studies. Excellent. Can you also talk about how you prioritize some of those specific histologies for FAP and, you know, how should we think about them, perhaps not only from an unmet need perspective, but also from a market opportunity and perhaps even a radiosensitivity perspective? Mm-hmm. Yeah. I guess as we're looking at those, we wanna stay away from crowded areas. We didn't include lung or breast, which, you know, if we had success, we could see that it would make sense to go into those more crowded areas. Looking at areas of high unmet need, pancreatic cancer, sarcomas, and looking at esophageal cancers as well is we saw that there's a real opportunity where we could make a near-term difference and then be able to have near-term success that would allow and validate us to move into more crowded spaces. That was why we chose those. They have high FAP expression, and that, you know, is a key criterion as we set our imaging thresholds to be able to set treatment there. That was really our strategy there. As we go into phase II, again, looking at combinations where those would make sense, you know, IO, there is synergy seen between radiation dose and increasing sensitivity to IO, that can allow you to, you know, potentially move into those other areas where, like melanomas, which could be a crowded space, but actually could take people that are refractory to IO there and be able to turn that back on again with these pretreatment. That's our strategy. We still have to learn a lot more in the phase I before we start setting out what phase II looks like. Got it. Great. Wanna move on now to PNT2001, your actinium, PSMA. I guess, you know, how should we think about this as a follow-on to PNT2002, and, you know, how are you looking to develop this asset? Sure. Our next generation PSMA molecule is different from the current generation of PSMA targeting molecules in the space. It's different in its PSMA inhibitor domain, its linker domain, and those actually impart a greater internalization. The reason that was important to us when we licensed this is a key aspect of that licensing is if you wanna use actinium in this space, you wanna see internalizing molecules. You really wanna take actinium, which goes through four decays, you wanna trap it in the cell, those decays and those daughter isotopes aren't in the circulation. That PSMA molecule met that criteria of getting a majority of the dose into the tumor. We've seen this in preclinical studies. We've tested this in a very challenging micrometastatic preclinical study. That's our conviction around using it with actinium. If you use the current standard of molecules, they're not internalizing as much. You see some off-target effects in the salivary gland. We spent a lot of time screening out the molecules that we had available to us to get to this lead, which we call PSMA-62. As we look at that profile and positioning, clinically, we're initially going to phase I study dose escalation in post-lutetium, post-chemo. We're taking patients at end of life, which we see a near-term opportunity there. We can generate OS data, potentially generate near-term approvals in that space. The real bold vision of the company is to move this early in disease. This will take some time, but to actually generate safety data in patients that are in the oligometastatic space, that will actually convince us that we could move into a setting where we might be able to prevent chemical castration. That'd be the real win is to move this molecule all the way up, addressing micrometastatic disease and delaying that chemical castration that, you know, is really, you know, patients are living with that for their entire lives, and it's a horrible state to be in. If we could make that difference, I think that would be a major impact on prostate cancer. Great. I guess moving on to PNT2003, you're a non-carrier added lutetium dotatate. Can you help us understand how this is different from Novartis' Lutathera? Sure. I think simply put, they use carrier-added lutetium, and this all gets down to the production routes. They irradiate lutetium-176 in a reactor. It actually generates impurities that bind to the dotatate molecule. Those impurities aren't detrimental to the patient, but they're very hard to handle within the nuclear medicine departments, and results in this complicated waste stream. Carrier-added's very clean, no long-lived impurities, no complicated waste streams. It's gonna lead to just a very more straightforward treatment, waste management and overall patient management process in these facilities. Got it. Great. Perhaps just to close out, could you remind us of your current cash balance as well as runway relative to some near-term milestones? Sure. We have greater than $500 million is on our balance sheet. That gets us into 2026. Again, if we with the milestones coming in, the regulatory milestones coming in of $250 million, as well as other commercial milestones, that, you know, takes us well past 2026, and we don't really see any midterm reasons for raising any capital. That's gonna take us past obviously the SPLASH readout, SPLASH approval. This is also gonna take us into phase II studies or past phase II studies on next-gen PSMA and the FAPI molecule too. It'll take us to very nice value-creating milestones for both of those compounds. Sounds great, and we definitely look forward to that. We are pretty much out of time now, but, Joe, I want to say thank you very much for your time today and for participating at our conference. Oh, thank you.