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Morgan Stanley 22nd Annual Global Healthcare Conference

Sep 6, 2024

Kelly McCarthy
Executive Director, Morgan Stanley

Okay, well, thank you everyone for joining us today. My name is Kelly McCarthy. I'm an executive director within the Morgan Stanley Healthcare Banking group, and I'm thrilled to be joined in person by Perspective CEO, Thijs Spoor. Actually, I'm gonna read this disclaimer very quickly before we get into it, but for important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. So welcome, Thijs.

Thijs Spoor
CEO, Perspective Therapeutics

Good morning. Thank you for having me here.

Kelly McCarthy
Executive Director, Morgan Stanley

Yeah, thanks for being here. And maybe just to begin, for those in the audience who aren't as familiar with the Perspective story, maybe you can just level set. Tell us a little bit of the history, how you came to where you are today, and what you're focused on going forward.

Thijs Spoor
CEO, Perspective Therapeutics

Sure. So we've had a really exciting origin story. The name Perspective came out of our name change, when previously Isoray and Viewpoint merged together. Isoray was a leader in Cesium-131 for brachytherapy. Viewpoint was focusing on targeted molecular therapies. Post that merger, because we used SPECT imaging, so we thought kind of SPECTive, and then that led to the whole Perspective name. Since that merger, we divested the brachytherapy business, and so for all intents and purposes, functionally, we're really focusing just on the radiopharmaceutical space. In the radiopharmaceutical space, the origin there was a really fascinating group of investigators in Iowa, who spent a lot of time looking at the whole periodic table of elements and seeing which radioactive elements are the best and how things can work.

They kind of zoomed in on lead being a really interesting way to go, and no one was touching lead at that time. And the interesting thing about lead is that you actually have two different versions, Lead-203 and Lead-212 And that prompted that team to think, what else could they do, especially with the acute need that they saw? And based in the University of Iowa, there's a Pediatric Neuroendocrine Center of Excellence there, where the whole goal is: can they make a safer drug for kids? So you can always find effective drugs for kids, but the big challenge is how do you develop the safest possible drug for a kid? And so a lot of the early research focused on really tweaking the biodistribution, tweaking the biochemistry, really focusing on what happens with the drug part.

Ignoring the isotope payload, what can the drug part do to give your highest possible therapeutic index for a kid? And it turns out that actually ends up being a safe thing for an adult as well. So with that vision, they formed the sort of company Viewpoint in twenty fifteen, and the view then was to then move forward and say, "Right, if they're gonna start to commercialize lead, what do you need?" And what was really required was a good chelator for lead and a good generator system, and neither of those was commercially available. So like all good scientists, they invented them. And so we have a proprietary chelator. We have filed IP on a chelator. It's the backbone of all the constructs we do right now.

On the generator system, as a way to actually obtain the isotope, that always gets tricky out of the gate if no one's supplying it. The Department of Energy has a lead generator that's available, like, the third Tuesday of every month, but that made it really tricky to actually kind of time your mouse experiments and do the work. Without meaning to become really good at it, we invented the generator as well. One of the interesting things about our company that people don't realize is the kind of, We're not just, right? And we're not just, you know, a drug developer. We're good at that, but we're also an isotope distributor, and we're not just that as well, but we also are really good at on the discovery side and doing clinical work.

So there's a lot of different things that we've had to do out of necessity, and by becoming really good at these things, we're leaning in and doing them more. So, you know, roll forward, there's a Series A that was done in 2020. Our science is so strong that during the founding years, we attracted $20 million in grants. And so as they say, other people's money is always better than your own, especially for some founders. And that moved things through, so a lot of validation from the NCI. And then, since then, we've got great, sort of recognition from The Street and the ability to go and sort of fund our programs.

Kelly McCarthy
Executive Director, Morgan Stanley

So you've got the isotope strategy nailed down. You've wrapped around these kind of enabling technologies around it. I think when it comes to lead, there have been, you know, speculation around lead as it's a commercially viable isotope because of the short half-life. How are you thinking about that? How are you addressing that? Is that valid?

Thijs Spoor
CEO, Perspective Therapeutics

So all questions are valid. But as we think about it, you know, one of the things that a lot of people on the street are not as used to because they haven't had ways to invest in it is really what, how short is a short-lived isotope? And so just my own background and where I've come from, before running Perspective, I took a few companies public. I've been in the field for a while as a research analyst. But thirty years ago, before it was really cool, I studied as a nuclear pharmacist, so I'll put out there that nuclear pharmacy is really cool right now. But you know, I started as a nuclear pharmacist, and we were dealing with products with fifteen-second half-lives.

The ability to actually produce these things that are a fifteen-second half-lives, ultra, ultra-short things, you go towards what can be used only in a hospital setting, if the patient's effectively almost attached to the isotope source, into the, one adjacency out from there, is those with sort of hour-long half-lives, and that's about 18 million procedures a year, across the U.S. You've got things with a two-hour half-life. So anyone that's gone for a PET scan gets FDG, or they get Fluorine-18 labeled a compound like Pylarify, and that's got a two-hour half-life, but gets distributed across the U.S. every day, multiple batches, a lot of patients. The workhorse of nuclear medicine is technetium, six-hour half-life.

So I brought in a logistics team from General Electric, from their short-lived isotope group, and they said, "What's the half-life we're dealing with here?" I said, "Well, we've got ten hours." Like, okay, that's, that's not, t hat's easier, right, than two and six. And so it's all a relative basis. But I think some of the questions that come out about half-life are, are kind of the wrong question because it really should be, it's not half-life, it's shelf life... and the shelf life of the drug you make is going to be about a day. Though some of the other radiotherapies may have a shelf life of two or three days versus our one day, but still the same logistical challenge, you have to do just in time.

And then paradoxically, you have to really tweak your manufacturing because you can't do things like two-week sterility testing on something that's only got a two-day shelf life. And so there's a lot of logistical complications that kick in, where thankfully, the street is getting a lot more informed now, as they appreciate that there are some really interesting ways to do this. And it's not really new problems we're solving, right? If you're a patient anywhere in the U.S., and you need a PET scan, it's never gonna happen within an hour. It's always sort of two or three days advanced scheduling, and the whole ecosystem of nuclear medicine, the radio pharmacies, the manufacturing sites, the nuclear medicine departments, they're all geared to have patients come in and receive a just-in-time product.

Kelly McCarthy
Executive Director, Morgan Stanley

Can you go one level deeper on the comparison of lead versus some of the isotopes that are in the more, you know, advanced programs or even commercial programs, actinium, lutetium, and that debate that's ongoing? How do you see, you know, the advantages of lead versus some of those isotopes?

Thijs Spoor
CEO, Perspective Therapeutics

I mean, it's the lead's got so many advantages, and so I have to look at the clock and make sure, okay, we only have 27 minutes. So I want to be sort of mindful about this. There's upstream, sort of before it gets to the patient, there's actually when it gets into the patient, and then there's downstream when it leaves the patient, and all the things are really important.

Kelly McCarthy
Executive Director, Morgan Stanley

Sure.

Thijs Spoor
CEO, Perspective Therapeutics

The nice thing about Lead-212 is that its precursor, Thorium-228, is one of the only isotopes in nature ever that you can truly stockpile. So things with a two-year half-life, like Thorium-228 , you can truly stockpile that and have it available on demand. Things with two thousand year half-lives or radiotoxins are never used. Things with sort of, you know, sort of twenty-day half-lives, you can't stockpile. So you have the ability to stockpile a Thorium-228 precursor, and that's a huge advantage on supply chains because it's taking a lot of complexity out of that system. When it gets in the patient, the idea of having short half-life isotope means you can hit a tumor hard and fast and then disappear, so you have an extraordinary luxury behind that.

When you're thinking about complex cancer biology, if you hit a tumor hard and fast with an alpha particle, which you don't get with a beta or with external beam, you get a crazy neoantigen storm, and that then allows this big response. What happens in the patient is you've got the innate immune system kicking in in three days, and the adaptive immune system kind of five to seven days. If you have a luxury of a short-lived one like lead, you can hit the tumor hard and fast and then have a very calm tumor microenvironment to help the body kind of respond and have the immune system kick in to really give a therapy throughout the whole body.

If you're doing something like actinium or lutetium, with both of those agents, you have a longer half-life, which means you're gonna actually fight the innate immune system, because those macrophages will be damaged as they come in and have the challenge of actually disrupting on the tumor microenvironment. If you go to lutetium versus actinium, lutetium as a beta, doesn't have the neoantigen formation the way alphas do. It has trade-offs. It gives a broader field of damage, whereas alphas give a very tight zone of destruction. If you're treating tumors in the pelvis, for example, you don't want a broad zone of damage. You really want it all the damage purely isolated to the tumor type and not to adjacent organs. There's lots of trade-offs that kick through.

The nice thing about lutetium and actinium is the chemistry gets pretty easy. There's off-the-shelf chelators you can use. The nice thing about what we do with lead is that we actually have a better chelator that actually holds everything really tight and guarantees everything sort of on to target. But then once it goes into the patient, you think about how are you hitting the dose rate? There's very few cases in oncology where a long, slow burn is considered a better approach for the tumor. If you need that, though, the great thing about lead is you could just do lots of little doses along the way. You could dose every week and actually get the equivalent of a long, slow burn, where that's all you can get with some of the longer-lived isotopes.

So we have the flexibility to hit hard and fast in a short time frame. We can do a long, slow burn if needed, and really tune what's gonna best respond with that, in that patient. But then the last bit is after the, you know, when the isotope shows up, logistically for the hospital, if they're trying to receive a product with a, with a really long, long half-life, they have to dispose of all the waste, and if you search the web, you'll find almost horror stories of stacks and stacks of boxes of vials with lutetium in them that were given to a patient. A residual amount cannot be thrown out in the waste. And so what you have to do with that is you have to store it for 10 half-lives. So in actinium's case, that's, you know, 10 times 10 days.

So you've got a hundred days where you have to store that vial with its residual amount before you can throw it out. That's... Okay, fine, that's space, that's a problem. But you also have to do that with the patient's biowaste. So their tubing transfer set, okay, that's something you can start to manage. And in Europe, you also have to do that with the patient's biowaste in terms of urine and stool and bedding and all these things. There's a lot of things that are out there. The best way to deal with radioactive waste is to leave it, let it decay, and do nothing, but that's ten half-lives. And so with lead, with a ten-hour profile, it's a couple of days, and you're good to go. With actinium, lutetium, it's ends up being in the months range-

Kelly McCarthy
Executive Director, Morgan Stanley

Okay.

Thijs Spoor
CEO, Perspective Therapeutics

And that ends up being more of a challenge. So, you know, across the board, it's a good question to say practically, what do you do with an isotope? How do you get it? What happens when it goes in the patient, and how do you deal with it when it's leaving the patient? But really, the question I hope people are asking is really: Well, what about the drug itself, and can you do the best possible drug? The isotope works in conjunction with the peptide or the antibody. We saw some really unfortunate data earlier this year at ASCO with someone taking an antibody in actinium and getting a lot of lung issues and lung deaths because you basically had a drug that didn't accumulate in the tumor fast enough.

It took about five to seven days, and those first five to seven days, it was circulating in the patient's bloodstream. You're effectively getting a whole body irradiation with actinium, and that really caused a major safety challenge, you know, sort of for those patients. It's not just the isotope, although you have to be able to get it. You have to be able to dispose of it. But it's also, what does the drug itself do? And that's really where we truly try and differentiate, where most people, I think, aren't really focusing enough, is what is the ultimate biodistribution? It's the biodistribution of a drug that matters.

Kelly McCarthy
Executive Director, Morgan Stanley

Let's go there. Let's go from the theory to the application and get into some of your actual programs. Maybe starting with your SSTR program in neuroendocrine tumors, what have you seen so far, the data there, that's encouraged you, and what's the next update?

Thijs Spoor
CEO, Perspective Therapeutics

Yeah. So as we look at the biodistribution of these drugs, we have great animal data. But as everyone in this room knows, you know, animals, you know, they're not necessarily. Mice are not the same as humans. They're not grateful, they don't pay, they don't always translate through. Yeah, it's a great indicator, but you have to be able to prove it out. What we like about lead is that we can actually do imaging surrogates with Lead-203. So we can get a perfect biodistribution in an animal or a human before we treat them. And so the animal data has shown we can get extraordinary results if we can get that biodistribution at the right level, if we can get them in neuroendocrine tumors, for example, that right ratio.

So what we've been doing right now with our neuroendocrine program is dosing patients in a dose-escalation study. We did two patients at a very low dose of two point five millicuries. The Safety Monitoring Committee said very quickly, "Go up a higher dose," and so we've been doing the five millicurie dose right now. We had previously negotiated or agreed with the FDA. It's always funny when someone says they agree or they negotiate. The FDA's pretty clear. If they tell you to do it, you're gonna do it.

Kelly McCarthy
Executive Director, Morgan Stanley

You do it.

Thijs Spoor
CEO, Perspective Therapeutics

So we agreed and negotiated with the FDA that we would see them after the first results at that five millicurie cohort. And so as part of our Fast Track designation, we had this obligation, commitment, agreement, whatever you want to call it, to speak to them, and we're happy to. They've been a great partner along the way. To show, to discuss our data, safety and efficacy, and really looking through what's there. Our Safety Monitoring Committee along the way very quickly said, "Escalate from two point five to five," which is the second dose cohort. They also recommended adding more patients in the five, meaning the drug was safe enough to really add in a lot more patients in that cohort if we need to or want to.

And they also recommended that we go up to that seven point five millicurie level. However, the data we're taking to the FDA will then inform our discussion with them to make sure that they're in agreement with where that goes. So I think people are really looking to see what happens in humans in this, what we're calling a first-line setting. So the radiopharmaceutical therapy, naive setting. So patients neuroendocrine, they'll get somatostatin, they'll get a treatment for their secretory tumors that's symptomatic in relief, but not curative. And I think if you look at the ORRs for somatostatin, it's only 3%. It's not really seen as a curative treatment, it's really managing symptoms. And so your first possible therapy with an impact can be Lutathera, and that's got a fairly low overall response rate in the package insert of 13%.

And all the data that's coming up in the compassionate use space, that's coming up in investigator-initiated trials, are showing a much higher potential overall response rate.

Kelly McCarthy
Executive Director, Morgan Stanley

So you sort of started mentioning, you know, potential application in the first line to compete with Lutathera. How are you thinking about later lines of therapy as well?

Thijs Spoor
CEO, Perspective Therapeutics

So we've been doing some work in the... let's call it second line, so the post lutetium world. And so the data there has been quite encouraging. Given the chance between that sort of first line, you know, instead of versus after, I'd much rather go into the instead of Lutathera bucket. There are a lot more patients there. Those patients have. There's a clear unmet medical need. There's a clear need for better therapy, something better than 13%. Those patients in that post lutetium environment, there's really no other choices for them, and so there is some activity there with some other agents in the radiopharm space, but those are patients where there is no other choice.

And it's the kind of thing where the concerns about safety are real for some of these other agents, and so I appreciate that patients need any kind of choice, some choice if, if they've been a prior Lutetium responder. We'd rather that we just knock out the disease much earlier. So we're open to... We have a pretty broad remit. We initially actually asked for a Fast Track designation in that second line setting, and after submitting our data, the agency came back to us and said, "No, you guys are in first line." So we were thrilled by that. We were not expecting it, we didn't ask for it, but the data is strong enough that we thought we actually could get into that Lutetium-177 setting and really start to explore how the drug can work.

Kelly McCarthy
Executive Director, Morgan Stanley

Can you talk just a little bit about how that trial is enrolling and any updates on, you know, progress?

Thijs Spoor
CEO, Perspective Therapeutics

Yeah. So, yeah, so we've had great response from the physicians on that trial. We actually have two phase II studies neck and neck, our melanoma program and neuroendocrine, and they both started within a month of each other. And both trials after that first cohort moved very quickly to the second cohort for enrollment. And so there's strong support, you know, sort of patient wait lists to come into the trial. The patients, in neuroendocrine space, are incredibly well-informed patients. They really understand what's out there. They believe that the alphas are better than betas. And so independent data, they've seen anecdotal things. They're firmly convinced that this is the way to go. Thankfully, the physicians are as well.

Patients and physicians are both really keen to get into this space and be enrolled in these trials. We enrolled quite quickly for both our melanoma and our neuroendocrine trials. Then we hit that limit of where we wanted to be with that first sort of data cut, and those patients are still being treated. The data is still maturing. One of the most common questions we get asked from investors is: When will it be presented, and what does it look like? What we said is that by the end of this year, we will have that data come out at a medical conference that's reasonable, and so share with the community, as we are sharing with the FDA, what's happening with those programs on both safety and efficacy.

Kelly McCarthy
Executive Director, Morgan Stanley

Okay, so on the melanoma program, specifically, you're gonna have an update later this year on cohorts one and two, right?

Thijs Spoor
CEO, Perspective Therapeutics

Right. So we'll be updating on cohorts one and two by the end of this year on the melanoma program.

Kelly McCarthy
Executive Director, Morgan Stanley

Okay.

Thijs Spoor
CEO, Perspective Therapeutics

The melanoma program is a different approach. Neuroendocrine tumors are a really homogeneous tumor. Melanoma is an incredibly heterogeneous tumor, and you get really, you know, completely different ways of thinking about how you manage these patients. The animal data's shown we do get some monotherapy efficacy, and we have to show monotherapy safety in order to be able to move forward. The value in the heterogeneous tumors is really on the combination approach, and we previously announced a deal with Bristol Myers Squibb to use nivolumab in a combination setting in conjunction with our drug in the melanoma patient group.

An advantage of using combination therapy in melanoma patients with such a heterogeneous tumor is that the way to think about it is you're taking a cold tumor and making it hot again, and that's not just the Holy Grail in melanoma, that's one, that's one of these, you know, major hot points across all of oncology, and so the proof of concept there is quite extraordinary. The animal data was great. We showed that patients with both an alpha emitter, our lead in this case, and some sort of IO therapy end up getting about a 45% complete response rate, and even to the point that those animals, if rechallenged, could never regrow a tumor. I mean, that's absolutely extraordinary to think about in oncology, where you can actually literally have a complete response with the inability to ever regrow that tumor again.

The ability to sort of change the immune system, train the immune system to really work, is truly transformational. We've got another grant for three million from the National Cancer Institute to support that, because it really, really changes things around quite drastically. We're doing a major protocol amendment right now to allow that first dose cohort, where the safety monitoring committee said alphas are very, very safe, to then allow them to also receive a combination of our drug plus nivolumab.

Kelly McCarthy
Executive Director, Morgan Stanley

Okay, terrific. Good to cover off the combination strategy there. In terms of building your pipeline beyond those two programs that we've already touched on, what's the latest development plan for your preclinical programs? What's the outlook there?

Thijs Spoor
CEO, Perspective Therapeutics

I have to, my job is to brag about the company, so I don't want it to sound like a brag, but I'm just so proud of our team. We have a team of sort of 15 MD PhDs in Iowa that do fabulous discovery work. We have in-house facilities that allow us to do really rapid, sort of product modifications, and change around the structures. I'll cite as an example, our FAP program, and for those in the audience, you can see all the images from that FAP program on our website in our corporate deck. But we spend a lot more time, we think we spend more time than most do, to really get that biodistribution right.

The biodistribution is critical in the radiopharm space because anywhere that drug goes, it's gonna cause damage. So an ADC lingering in the kidneys doesn't necessarily cause a safety issue. Any radiopharm lingering in the kidneys will cause a safety issue, and so you have to be super clear about what's going to tumor and what's going off target, and that development is so important. There's a great image that we can show where you've got three different animals with sarcoma, and in that situation, with three different drugs, one of them goes only to the tumor, and the other one goes to the tumor and kidneys. So if you had to choose, which one would you put into a human? It's gonna be the one that's only going to the tumor. You don't want it lingering on the kidneys.

So we have a pretty unrelenting approach that we don't bring anything into a human until we've done this work on the biodistribution, changed the molecule, changed the chelator, changed the linker, changed the peptide, do a lot of changes on that formulation, and only then pull things into the clinic. We had another competitor that had a really unfortunate issue where they brought up a FAP program into the clinic, and we felt that they didn't have enough of that sort of, you know, tumor-kidney ratio figured out. And so it feels like that program's been abandoned because you just don't if you don't get the right safety profile, you can't really develop as a therapy. So we have many programs ongoing at various stages of development.

Some of them, we solve very quickly, some of them take a bit longer, but we're continually iterating through, evaluating the products real time. We have the luxury, too, by using Lead-203, so the imaging version of that isotope, where we can do regular studies rapidly in the same animal over and over as its own control to perfectly predict the dosimetry in that animal, and so we have the ability to actually run these simulations real time in vivo and really identify which compound should be best, and then we have to pray that the mouse-to-human transition, you know, works out reasonably, but we can also image a human and see really clearly if that drug is working.

And so we showed some terrific images of our FAP program, of a patient with osteosarcoma, of a lung cancer patient, and a neuroendocrine patient, each of which had very different FAP patterns that really showed incredible potential for a therapeutic there. So, you know, long way of answering your question, which is we've got a whole bunch of programs coming out. We're trying to get one out into a human image every eighteen months or so, which we think really de-risks things.

Kelly McCarthy
Executive Director, Morgan Stanley

We've been focused mostly on the therapeutics pipeline, but how do you think about... And you started talking about the imaging of, you know, these patients. How do you think about the diagnostics piece of your business? Do you think of yourself as a theranostics company, or is that kind of more enabling to your therapeutics pipeline?

Thijs Spoor
CEO, Perspective Therapeutics

So we are a theranostics company because of the embedded imaging portion is so important for drug development. But the commercial world gets a little bit different, and as we think things through. Part of my origin story, I spent time at Amersham GE. I spent 11 years there really working on the whole imaging side of the radioisotope business. It's a great business. That's not the business that we're in, and there's some really strong players in that business right now that are really doing amazing things for diagnosing PSMA-positive patients, SSTR-positive patients, on the Alzheimer's side, on the cardiology side. That's not our focus. We're trying to really treat patients with cancer.

In the case of our SSTR2 program for neuroendocrine tumor, there is an approved diagnostic imaging agent, and so I don't think it's good use of our shareholder funds to go through all the process to register a new diagnostic imaging drug when there is something out there that we're incorporating in our clinical trials that actually looks like it does a really good job. With the melanoma program, that's where the challenge kicks in, because there is no approved good diagnostic for MC1R expression, right? You can diagnose a melanoma patient, but you can't pick up that expression except if you use our drug as its own biomarker. And so that strategy is evolving for what to do from a theranostics approach. We don't want to just diagnose disease.

There's a lot of ways to do that that are really good, established, and work quite well, and patients can have access to. We want to find patients that will respond to our therapy. And so using the same chemical entity as its own biomarker is a fabulous way to actually go and actually figure out, you know, which patients can benefit.

Kelly McCarthy
Executive Director, Morgan Stanley

Okay. The other critical piece of the business model is obviously the manufacturing, and you've made some key investments there, over the years. So maybe you can talk about your manufacturing capabilities and how, you know, your focus on lead is informing your strategy around that.

Thijs Spoor
CEO, Perspective Therapeutics

So it's a great question because no matter what isotope you're going with, and if it's lead, if it's fluorine-eighteen, if it's actinium, if it's lutetium, iodine, the best way to actually roll out a manufacturing footprint is a distributed network. And I challenge people to find any modern management supply chain theory that says a single node of operations that could become a single point of failure, is the most reliable way to develop any network. And we've previously received a lot of pushback on that, but I think what's coming out in the news, especially lately, Novartis has said they're building out several facilities now across the U.S. and around the world. No matter what isotope business you're in, you need a distributed network of sites, and we've always maintained that's the most efficient way for us to run a lead business.

We have a site right now in Iowa that we use to supply product for clinical trials. We have a site in Somerset, New Jersey, that will be coming online, we're hoping this year, to start producing doses. If you look at our last Q, we bought a facility in Houston, we bought a facility in Chicago. We're probably gonna build some more, and hidden in plain sight in every corporate deck we've had for the past two years is a map of where high-probability locations are to actually kind of put these facilities. It gives you a distributed network that allows for ground distribution of product, and usually supplemented by air, and that's for our own sites.

There's also an extraordinary CDMO network that's out there, and we'll often get challenged on the concept, "Well, do CDMOs actually work in this space?" The great thing I'd point to is Lantheus has, you know, a pretty phenomenal drug, Pylarify, for imaging, that accesses north of 50 GMP CDMO sites across the U.S. So the whole ability of like, well, yeah, you have to like, you know, look at their quality systems and how do you audit them? You do. It's just the reality of the business, and you can put multiple sites on your drug master file. You can put multiple sites to manufacture your program. They don't have to be your own, and there are four competing commercial networks in the CDMO space that are also very keen to support and efforts of companies like ours.

and they're all building Part 11 compliant facilities. They're rolling out pre-distributed footprints. The one thing this industry knows how to do is to really kind of build out last-mile distribution logistics. And so some of it we solve ourselves, some of it we solve with partners.

Kelly McCarthy
Executive Director, Morgan Stanley

So how do you transition from, you know, the clinical to the commercial in terms of that footprint and the investment actually required, or even, you know, the CDMO network, you know, where are they from an infrastructure perspective to be able to meet that opportunity over time?

Thijs Spoor
CEO, Perspective Therapeutics

The whole industry is really building and growing right now, and so that CDMO footprint is being established. There's some existing players, you know, Cardinal Health, PharmaLogic, that have a lot of experience in the SPECT and PET world, and they're expanding then into the sort of therapeutic space. You've got some academic spin-outs that are just focusing on the therapeutic portion. They're trying to build out distributed nodes. There's capacity coming into the system. It's so hard with any one CDMO or innovator to really figure out, you know, what can you commit to? And so without knowing if our drug works, we're not necessarily gonna commit to a full-on commitment to guaranteeing X number of products that we're gonna buy from someone, so we know our drug works.

At the same time, the CDMOs aren't gonna commit to building out extraordinary dedicated infrastructure unless they know that's coming in. It's a natural dynamic that evolves of trying to really secure supply chain, manufacturing slots, space, all those kinds of things.

Kelly McCarthy
Executive Director, Morgan Stanley

I'll ask you to keep the finance hat on for another minute. You in your most recent quarter reported $293 million in cash and equivalents, and guided to cash runway into mid-2026. How are you thinking about capital allocation strategy in the near term, both internal R&D, external opportunities, business development? How are you thinking about deploying that?

Thijs Spoor
CEO, Perspective Therapeutics

So we think across our three verticals in terms of discovery, manufacturing, and clinical trials. And so the discovery team keeps developing novel composition of matter IP, and so we want to keep feeding that. They're so prolific. We keep inventing, we keep patenting, and so we want to make sure that group is fully funded, and they are, to keep innovating and doing what they do, which is discovering new drugs that are transformative. We do need to invest in our infrastructure. You know, following the math through that $292 million, and you can look at our monthly burn right now being in that kind of $5 million to $6 million range. That should put us way past, you know, sort of two years, but obviously, we're gonna be building out infrastructure on the supply chain side.

And we also have the resources now to complete all the dose escalation work we're trying to do too. So we have dose escalation and dose expansion. The dose expansion work is covered on the major programs we've listed, so we're gonna be sort of pretty mindful. Our spend is expected to increase if things go well. If things go horribly, the spend will really decrease, and we'll have a much longer runway. So we've tried to really model and guide to the fact that our products look like they are working, and we need to sort of add in our capacity on the supply chain side as well as on the discovery side.

Kelly McCarthy
Executive Director, Morgan Stanley

... We're definitely rooting for things to go really well for you.

Thijs Spoor
CEO, Perspective Therapeutics

So thank you, and you know, there's a great phrase that BioNJ has, and I encourage every innovator to be a member of BioNJ, and their phrase is, "Because patients can't wait." And we, we've told our manufacturing sites that, and our production teams and said... We've told everyone across the company, you know, "Patients can't wait." So anything we can do to really innovate and drive things forward is absolutely critical, and we're doing whatever we can to get product out as fast as we can.

Kelly McCarthy
Executive Director, Morgan Stanley

So the last question for you, there's been a lot of strategic activity in the radiopharma space, a lot of investor focus in this arena. How do you, as Perspective, think about, you know, being a leader in that space? What excites you the most going forward about being in that evolving arena?

Thijs Spoor
CEO, Perspective Therapeutics

So the nice thing about the evolving arena is that the debate two years ago was really alpha versus beta, and I think that's been resolved, that alphas really have a really strong place. Last year, there was a debate that was fairly heavily contested: Is there a space for lead at all vis-à-vis actinium? And that's being resolved now, and I think the sentiment is really shifting into there is clearly a role, not just on the isotope basis, but let's find the best drugs that win, and that's always been our focus. Find drugs that are winners, find drugs that have the best possible therapeutic window, find drugs that are safer for kids, find drugs that are safer for unmet medical needs, and really develop those further.

What's rewarding to me as a nuclear pharmacist is that now there's a lot of investor interest in something that was always ignored, right? It was always nuclear medicine never really a hot area. It was, you know, you had sort of Zevalin and Bexxar in the early 2000s that struggled commercially, but now you're getting really interesting products that have much clearer ways to get used, much clearer ways to diagnose the disease, ways to really kind of grow things forward. The nice thing about this field is that there's a lot of interest and investment in the unmet medical needs space. We're gonna lean in on things where we have differentiated assets with really strong IP. We've learned that we can be really good at multiple things, and we're really trying to drive things forward.

Kelly McCarthy
Executive Director, Morgan Stanley

All right. Thank you for joining me today. Thank you for attending our conference, and thanks to everyone in the audience for joining us here in person today.

Thijs Spoor
CEO, Perspective Therapeutics

Great. Thanks for hosting us. Really appreciate it.

Kelly McCarthy
Executive Director, Morgan Stanley

Thank you.

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