Good afternoon, everyone. Our next presentation is from POINT Biopharma. Joining us today is Joe McCann, CEO. After the presentation, there'll be time for some questions. Joe, the floor is yours. Take it away. Thanks. Great. Thank you very much. Good afternoon, everyone, and thank you again for the invitation to present. I'll tell you a little bit about POINT Biopharma. We're a clinical stage precision oncology company founded in January of 2020 and listed on the Nasdaq in July of 2021. POINT's focus is in radioligand therapy, and I'll tell you a little bit more about that in a few slides. This is a space that has grown exponentially in the last few years. There's been well over a $1 billion in investment. There have been multiple radiopharm companies appearing almost monthly. A real hotbed of innovation and focus for the industry. I'd say this has really been driven out of decades-long information out there showing that these drugs are efficacious and safe. Really, Novartis has kicked this off most recently with the $2.1 billion acquisition of Endocyte, which they took that drug that they acquired there, PLUVICTO, through approval, and are currently marketing that and anticipate yearly sales this year in prostate cancer, metastatic prostate cancer, to be north of $1 billion. This is phenomenal execution in that space. The interesting part of what Novartis has done, and I'll get into why this is the big challenge in this space, is they've done that in the face of massive supply chain disruption and challenges. It's amazing to see the uptake in the space. It's amazing to see the excitement, and it'll be more exciting to see this once the supply chain is truly worked out. We've focused on supply chain since this company was founded back in January 2020. Showing here on the left, we focused on that vertically integrated discovery and development platform. That's allowed us to actually, when we launched the company, to almost immediately start a phase III trial, which I'll tell you about. We've completed recruitment in that trial. Expect top-line data later this year. This is built on a strong base of robust supply chain. Very early on, July of 2020, we purchased a facility in Indianapolis, 80,000 sq ft. We built that out not only to manufacture these products under strict GMPs, but also to manufacture the input isotope that goes into that. I'll provide some more detail on that. We see our pipeline. Beyond the phase III program, we see a strong pipeline as we bring through both development candidates and discovery candidates. We're also now evaluating some in-licensing opportunities. We see significant near-term revenue that's actually gonna be driven out of a licensing agreement that we've signed with Lantheus, which is a leader in the imaging space targeting PSMA. That, again, was focused on our two late-stage programs. Our pipeline programs all remain POINT assets, and that's could generate up to $1.8 billion in revenue for POINT. Our team was built very very early on with proven experts in this space, not only in the manufacturing, discovery, but also clinical development. That has really allowed us to move very, very quickly from concept in a phase III trial to execution and completing of recruitment back in December of 2022. We're financially strong. Our licensing deal with Lantheus gave us an injection of $260 million in December of last year. That puts about $541 on our books, which gives us cash runway into 2026. Taking a step back and looking at radiopharmaceuticals kinda from the 30,000-foot view. When we talk about radiopharmaceuticals, it's really about harnessing all the benefits of external beam radiotherapy that you can focus on specific tumors, but doing that systemically, where you tie a radioisotope to something that targets a certain biomarker on cancer. That biomarker seeks out or that ligand seeks out the biomarker, enriches that isotope into the tumors, and systemically can provide the amount of radiation that you're getting from external beam. The interesting thing in this space, and I'll focus in on radioligands, and a cartoon is shown there, where you take the radioisotope. These can be alpha emitters, beta emitters, which are your two main therapeutic radioisotopes. You can actually combine that with radioisotopes that emit light, and you can image it. This gives you this concept where if you can see it, so when you inject this with this targeting moiety that goes after a certain biomarker, lights up the disease, you know that that biomarker is present. You can switch that out with a therapeutic isotope, and you can treat it. I think that is the big advent in this space which happened with prostate cancer, where you had all of these physicians at the biochemical recurrent space seeing their patient's disease advance. We're actually now getting more patients diagnosed with advanced metastatic disease earlier, getting them on treatment earlier, and this is actually creating a real opportunity for both the patients but also the treating physicians to be able to move forward in a very challenging disease space like prostate cancer. When we step back and look at the market, this is something that has really evolved only in the last probably 18 months. With all the investment in the space, we're actually seeing this space go beyond prostate cancer and neuroendocrine, where it's really spent the last 20 years. We're seeing new targeting approaches, new discovery platforms that are going to be able to bring RLT into diseases like ovarian cancer, lung cancer, breast cancer, which has not been seen before. In addition to that, the technology to create or generate new isotopes and new from a medical standpoint, to be able to give more options to the drug development companies. It's not just your traditional lutetium, which is a beta emitter or actinium, but it's going to give you a large range of half-lives and different energetic properties, which should again help expand this into different disease indications. When we initially started the company, we actually thought that access was going to be the major barrier here, so patients actually getting into a clinic and getting injected with these drugs. What we saw when PLUVICTO launched, the Novartis prostate cancer drug, was that was not the bottleneck. There has been no reported barriers to patients getting access here, so we're very happy to say that in the clinics that are operating, they have the capacity to take on more. In this space where we're seeing people move away from chemotherapy, there's actually, we believe, a drive and a business case for these clinics, these community-based clinics, to actually start transitioning over to RLT therapy. You're gonna get this expansion in the space, which again is going to be there to receive new drugs as they come on the market. When we look at the healthcare practitioner side, the imaging piece is so helpful with radiopharmaceuticals. Seeing these very high-resolution images, understanding their patient's disease, and understanding that now you can switch that to a therapeutic isotope, gives them not only the diagnostic information, but that hope of being able to treat the patients. Finally, from a combination standpoint where we see a lot of potential drugs, is in the preclinical setting, we're seeing a real synergy between RLT and drugs like immunotherapy. Not in this presentation, but in our corporate deck, you'll see some of those combinations that are quite striking for this class of treatments. With POINT, as I mentioned, we very early on focused on manufacturing. We know this is where we're gonna win. My career started in manufacturing these products, so our first investment was in a facility in Indianapolis, shown here, where we very quickly started to design, build that out, and late last year, or sorry, early last year, in January 2022, we started to ship our first products from that facility. We're now actually scaled larger than our competitor, and are ready to do our regulatory filings and be able to meet the market need when we anticipate approval in possibly in 2025. Manufacturing is one part of this, where you combine the isotope with the radioligand. The other part of this is getting that radioisotope, and that is a huge challenge, mainly on the actinium side, but I'll talk to you first about lutetium 'cause that's where the major therapeutic benefits have been seen to date. On the lutetium side, there are manufacturers out there, but only a few. Really only one large-scale manufacturer called ITM. Again, very early on, we put all the investments to create a supply chain that was North American-based. The current supply chain has exposure into Russia, has the base of manufacturing being in Europe. Since these are radioactive, they decay over time. The closer you can get all of that production to where you're making these drugs, the greater cost of goods advantages you have and the more reliability of that supply chain. We brought all these components into North America to create POINT, not only having its manufacturing facility in Indianapolis, but its isotope production there. When we go to launch commercially, we're looking for about a 50/50 blend between our internal lutetium production versus our external needs. You want that. You always want redundancy in this space, so we always wanna maintain very good relationships with our third-party suppliers. On the actinium side, actinium is a very exciting isotope, a lot of work being done there. We'll be putting in a phase I study in prostate cancer later this year with actinium, very, very challenged to get access to. Right now, the U.S. government is really the only reliable supplier of actinium-225. We've put in a lot of effort to identify the leaders in the space, create priority contracts with them, so that when we launch our phase I trial, there's ample amount of actinium available to us. There are no delays as we run through phase I, phase II, phase III, and look to scale these commercially. The other area, this is probably small for you in the back of the room, but the other area where we focused on with the recent licensing milestones that we received from Lantheus, is building out a robust discovery platform. The nice thing, as I mentioned before, about these drugs is you can see them. You can actually measure and quantitate how much gets into tumors, not only in humans but in animals, and do these very rapid high-throughput screening evaluations to select candidates. You can see here we have a, you know, number of mice being evaluated. You can take that, do the calculations, figure out if you're getting the right amount of isotope into those tumors for long enough. If you're not, you have this iterative cycle. What we actually like is once you have leads that you can bring into the clinic through phase O or exploratory IND approaches, you can actually start using this imaging at subtherapeutic levels to understand what this looks like in humans. Again, if you're not seeing what you wanna see, you can go back and continue this cycle. This is unique in the space because of that key imaging component. You're not taking a therapeutic product into the clinic, subtherapeutic, but you can actually measure the therapeutic amount of lutetium that you deliver, say, for example, before you even head into a phase I trial. Capital efficient, getting the most optimized product into the clinic, and then of course, you continue on with your phase I efforts. Here where we've invested, and this is actually a local story 'cause we've taken over a facility in Toronto that provides us with all access to GMP capabilities, imaging capabilities. This is in partnered with the University Health Network and Princess Margaret Cancer Centre, where they have a GMP facility POINT will run, and we'll actually use that to tie into their theranostics center so we can really live this second part of what we're showing here in these early-stage studies to get that information. Quickly iterate and get into phase I studies and move very rapidly through development, or very importantly, kill programs early before you put too much investment into them. Shown here is our pipeline. The two top programs, PNT2002 and PNT2003, they're the late-stage programs that we have licensed to Lantheus. I'll tell you a little bit more about that deal later on. All of POINT's early-stage programs remain in POINT's control. We have exciting pan-cancer assets we have in phase I, targeting fibroblast activation protein, which is expressed in greater than 95% of tumors, virtually absent from healthy tissue, so a perfect target for radiopharmaceuticals. We have additional programs in actinium PSMA, where we're actually looking at placing the treatments very, very late in disease, where patients are actually losing opportunities as they blow through chemotherapy. As well early in the oligometastatic and biochemical recurrence space. Our Chief Medical Officer has a real vision that we can turn prostate cancer into how they treat thyroid cancer. In thyroid cancer, you have your thyroid removed, you're treated with a shot of I-131, so radioactive iodine. It seeks out that tumor tissue and eradicates it. These patients are cured. We believe that there's a strong opportunity to actually do that with an alpha-emitting radioisotope and actinium-225 tied to PSMA targeting and actually hit these patients very early on in their disease, such that they may never have to go on on any hormone treatments, which would be a real game changer in the space. Again, we have a discovery program that's very active, looking at identifying new ligands with different high-throughput discovery technologies, tying it with a variety of isotopes so to go and seek out other areas where POINT can maintain or achieve differentiation in isotope access, and then looking at combinations with different IOs or DNA repair agents. I'm gonna walk you through our phase III program, the most important milestone for POINT this year. Our phase III program has completed recruitment in December of 2022, and we anticipate top-line data in the second half of this year. This clinical trial targets men when they fail second-line hormones, so that would be abiraterone, enzalutamide. Really, there are a lot of these men actually choose to go on cycling of the various hormones, which isn't a very effective way to treat the disease, but it does give them short durations of progression-free survival. It's a great alternative for them versus chemotherapy, where they just don't wanna take that hit on their quality of life. We... I'll show you the study design in a moment, but what we're actually seeing is this population of patients is growing significantly. The number of patients has actually increased based on the current market projections, about 10,000 in the U.S. in the last year, just based on the fact that patients are now getting diagnosed earlier with metastatic disease due to the advancement in PSMA imaging. Complex slide. I'll break this down for you to give you a sense of how our trial is designed. This is, again, looking to randomize patients to go on the lutetium treatment, PNT2001, versus going on the next cycle of androgens. They fail their second-line therapy, and these patients are choosing not to go on chemotherapy, so they get randomized to either our drug or another one of the second-line treatments. For example, if they fail abiraterone, they would be randomized enzalutamide on the control arm or vice versa. We broke this up into two components. Given that we came, you know, founded in 2020, really took academic literature to the FDA as a basis to start this phase III study, the FDA asked us to run a lead-in, single-arm lead-in, which has actually proven to be quite valuable in understanding the efficacy of this drug. On the left-hand side, we have a single-arm lead-in where we did our entire treatment regime with 27 patients, looked at them not only from a dosimetry, so how much is hitting healthy tissue versus diseased tissue, but as well looking at efficacy. Once we were done that, we were able to move into randomization, which is the right-hand side of this slide. That trial or that initiated in September of 2021, and we just completed that in December of 2022. Now we're watching events come through and look to report top line second half of this year. I'm gonna tell you all about the data that we had from our single-arm trial, just to show you how very encouraging that data is and how we think it really sets the stage for a successful trial from the phase III randomized section. Highlights of what we saw and what we published at ESMO last year. Again, this is in 27 patients, we saw radiographic progression-free survival of 11.5 months. That's significant compared to what we saw with the competitor PLUVICTO, although in a later line of patients, they saw about 8.6 months. That's a significant improvement on what the current data is out there. We didn't really see many deaths over the course ahead of pulling this data. It looked very good from a median OS perspective. We had a very strong response rate with 60% ORR. Again, there are only about 10 evaluable patients there, that was still pretty striking compared to what you saw from the VISION trial, which was, I believe, sitting around 30%. PSA response, which is the key response rate that everybody looks for, we saw that at 42% of patients received a PSA of 50. Very safe, very mild side effects. On the eligibility side, this is where your PSMA imaging actually makes you a candidate for the study. 85% of patients are eligible based on PSMA imaging, so quite high in the percentage of patients that could eventually receive this drug once it's marketed. When we looked at the number of patients that remained on trial, and it's important to put this in context, this part of the trial ran before there were COVID vaccines, so very, very challenging and few sites, which we had a lot of patients travel to these sites for these treatments. The 70% that remained on trial, we actually think is really an outcome of the circumstances that this was run under, and our team did a phenomenal job of getting this done during COVID. We're actually seeing significantly higher treatment rates in the randomized part of the trial, showing that a majority of patients, a significant majority of patients, receive all four cycles. The biodistribution of the drug and the dosimetry of this drug were as expected. Some key highlights are that 11.5-month RPFS. To put that in context, we expect the control arm RPFS to be around 3.5- 4.2 months. We know this because there have actually been a number of trials run using that exact same control arm. There's great data out there to direct us that we have a significant delta between the treatment arm and the control arm, which gives us a lot of confidence as we look to reveal that data later in the year. As we look at the PSA response, again, this is the big measure that everybody still uses, although we don't believe it's the best way of looking at this radiographic responses. A very strong 42% of patients had a PSA decline of 50% or greater. This is comparable to any non-androgen targeted drug, be it chemotherapy, the PARP inhibitors, so falls in line or greater than what the current options are for patients. Just showing one of the best cases, and just to kind of give you an idea visually in one of the complete responders, you can see the tumor there with the white arrow, and then you can see came with a PSA of 30.6, rapid drop 11 months later, and still the disease has not returned. You know, a very strong response here, and again, made us really encouraged as we move through this trial. From the safety perspective, which really you get a hint of that with dosimetry. Again, dosimetry is a measure of how much dose or radioisotope you're actually delivering to the healthy tissue. We saw from a kidney perspective, which is how these products are excreted, so you're always looking at how much doses the kidney is getting. This is below the FDA limits. Where we really saw a striking difference between our product and our competitor's product is actually in red marrow and lacrimal and salivary. A big complaint for patients who are on these drugs is dry mouth. We saw about 3x less lacrimal and salivary gland dose, and we believe that's going to manifest itself in a lower incidence of dry mouth. On the red marrow side, again, we saw significantly less exposure here as well, and we believe that that's actually gonna translate in probably a better or lower side effect, hematological side effect profile in our trial. Again, we have to see how this all pans out in the phase III. Looking at anticipated milestones and our financial summary, and this is where we'll talk a little bit about our deal with Lantheus. We've received that $260 million payment on closure of the deal, that was received in December. On regulatory approval, which again, if everything goes as planned, we'd expect this to be in 2025. For the prostate cancer asset, that'd be $250 million. For the other asset, PNT2003, which is in neuroendocrine tumors, that could be upwards of $30 million that we'd see in 2025. It's the ongoing milestone payments paid on hitting certain commercial sales numbers, which could reach up to $1.5 billion. The 20% royalty on the product plus the manufacturing revenue that we'll make on this. POINT put a massive investment in to be able to manufacture these at scale so that we could compete with the likes of Novartis. With that investment, we've actually been able to create a real differentiated position in the space to be able to manufacture at those scales, and that put us in a great position to negotiate good transfer pricing on the product. That creates a separate revenue line that will be tied to our manufacturing facility. With this capital, we'll be deploying it in looking at different isotopes in the space. Here are shown some examples, isotopes such as lead, terbium, astatine give you those different profiles of half-life and different emissions of and energies of the various missions to be able to have a tool chest where we can actually tailor these and tune these for the different diseases. Look at partnerships, bringing in different ligands and different ligand screening technologies, and establish those with proven, and emerging types of technologies. Of course, focus is internally for our discovery programs, to be able to drive those forward quite rapidly. Looking forward, we have the key milestone this year is really that top-line data in the second half of the year. We will be starting that actinium PSMA program. Again, that's targeting patients very late in disease, but also, earlier in disease in that biochemical recurrence oligometastatic space. We look to dose our first patient by the end of this year. Again, strong balance sheet with cash into 2026. Just the final summary and takeaway on POINT Biopharma. We've differentiated ourselves by having a robust isotope supply chain. We're not just an actinium company. We're not just a lutetium company. We actually look at all isotopes as tools and create very robust supply chains that will allow us to drive clinical trials but also drive commercial execution. Strong radiochemistry with the recent partnership, of course, with UHN in establishing that facility to be able to drive forward the discovery aspects of our work, move into those kind of phase O studies to screen more candidates. Our next-generation clinical programs that are ongoing right now. Of course, the commercial scale manufacturing, which we do believe is gonna truly differentiate us and allow Lantheus and POINT t o compete head-to-head against Novartis and their PLUVICTO product. Thank you very much for your attention. Thanks, Joe. If you have any questions, please raise your hand. All right. Well, thank you, Joe. Thank you.