Perspective Therapeutics at Barclays Healthcare: Radiopharmaceutical Innovations

On Tuesday, 11 March 2025, Perspective Therapeutics (NYSE: CATX) showcased its strategic advancements at the Barclays 27th Annual Global Healthcare Conference. The discussion led by CEO Ed Sbor highlighted the company’s robust radiopharmaceutical platform, detailing its supply chain resilience, clinical trial progress, and differentiation in targeting technologies. While the company faces challenges like potential tariff impacts, its U.S.-based isotope sourcing and innovative manufacturing strategies offer a strong competitive edge.

Key Takeaways

• Perspective Therapeutics mitigates tariff impacts by sourcing Thorium T2O8 from the U.S. Department of Energy.
• The company is expanding its manufacturing capabilities with new facilities planned in Houston, LA, and Chicago.
• Clinical trials for SSTR2 and MC1R targets show promising results, with ongoing FDA discussions to optimize dosing.
• Perspective’s FAP target differentiation focuses on minimizing non-tumor tissue accumulation.

Supply Chain and Manufacturing

• Impact of Tariffs: The company’s reliance on U.S.-sourced Thorium T2O8 limits tariff impacts, addressing key supply chain concerns.
• Manufacturing Expansion: Existing facilities in Iowa and New Jersey support clinical and commercial operations, with new sites planned across major U.S. cities.
• Shelf Life and Distribution: Leveraging a 24-hour isotope half-life enhances distribution efficiency, supported by a new deal with Sanofi and Radiomatics for centralized distribution.

Clinical Program Updates

• SSTR2 Targeting Molecule (Neuroblastoma): Fast track designation from the FDA, with ongoing patient monitoring and cohort expansion following positive initial results.
• MC1R Target (Melanoma): Collaboration with Bristol Myers Squibb for combination therapy with OPDIVO, showing stable disease in patients beyond expected progression-free survival.
• FDA Feedback: Adjustments in dosing to address renal accumulation concerns, with continuous data monitoring to refine therapeutic strategies.

FAP Target Differentiation

• Perspective’s approach focuses on optimizing molecule design to ensure effective tumor targeting while reducing non-tumor tissue accumulation, enhancing therapeutic efficacy.

The full transcript of the conference call provides further insights into Perspective Therapeutics’ strategic direction and innovations.

Full transcript - Barclays 27th Annual Global Healthcare Conference:

Peter Lawson, Biotech Analyst, Barclays: Thank you so much. So my name is Peter Lawson. I’m one of the biotech analysts at Barclays and really pleased to have on stage with us, Ed Sbor, the CEO from Perspectiv Therapeutics. And I guess my initial questions for everyone has been the impact of tariffs and how that could potentially impact supply chain and if there’s anything we should be thinking about whether it’s industry wide or company specific.

Ed Sbor, CEO, Perspectiv Therapeutics: Sure. No. Thank you, Peter, and thank you for hosting us here at the conference. It’s always a relevant question on everyone’s mind when you think about the supply chain and the precursor materials. And so the amount of actual peptide that we use in our programs is pretty small and is produced in The U.

S. But really the big question in everyone’s mind independent of tariffs on this radiopharmaceutical supply chain is where does the isotope come from. And so to cut to the chase, Thorium T2O8 is the ultimate precursor for what we do. Thorium T2O8 is found relatively abundantly around the world inside reactors and things like that. But there is a U.

S. Supply to the U. S. Department of Energy. There are sources in Russia, in The U.

K, in The Netherlands, Australia. But we predominantly source from the U. S. Department of Energy. And so our precursors are not dependent upon how the any tariffs that may show up in terms of what we’re trying to do.

Peter Lawson, Biotech Analyst, Barclays: Got you. And then the FDA potential cuts, your fear of cuts, has that changed in any way the communication pattern with the FDA? Has it delayed things?

Ed Sbor, CEO, Perspectiv Therapeutics: Have you

Peter Lawson, Biotech Analyst, Barclays: noticed any changes? No. So any potential cuts and change

Ed Sbor, CEO, Perspectiv Therapeutics: of the FDA, we have not seen any impact on how we engage with them. We found the FDA to be consistently very supportive of innovation and new therapies and a really dedicated group of professionals trying to help bring new therapies forward. And so we have not seen any acute impact for anything that we’ve done at this point.

Peter Lawson, Biotech Analyst, Barclays: And then a final macro question would just be around NIH funding, cutbacks there. I mean, clearly, could have long term impacts on biotech industry as a whole. But are there any kind of near, mid term effects that you worry about even if it potentially trickles down to university funding and

Ed Sbor, CEO, Perspectiv Therapeutics: So there are some really drastic acute impacts from NIH cuts. And as we look at a lot of our clinical trials, we’re doing work in oncology. And a lot of the university and academic centers that do work in oncology are major recipients of NIH grants and that has a direct impact on their operating budgets. And so, our clinical sites are feeling systemically the impact from their institutional budgets being drastically cut and really scrambling to try and find out how they provide integrated cancer care to their patients. And so, every institution that we deal with that does research is impacted by these cuts.

And the read through is into patient care pretty acutely. So, it’s number one on people’s minds as we speak to our clinical trial sites as we look to see how they can operate.

Peter Lawson, Biotech Analyst, Barclays: Thank you. Thanks. Really great insight. And then kind of as we think about your own company and manufacturing, I wonder if you kind of talk through where you are for the building out of manufacturing, Clearly an important part for the radiopharmaceutical space.

Ed Sbor, CEO, Perspectiv Therapeutics: No. Thank you. So the supply chain, if that’s the radiopharmaceuticals, is going to be dependent upon your product shelf life and how far how much time you have and how far you’re trying to get the product. So with the Lyd C12 isotope, we can think of product shelf lives being up to about twenty four hours, the isotope of the ten hour half life. But the effective product shelf life is about twenty four hours.

And so that means we have ideally same day distribution or potentially overnight. There was recently announced deal between Sanofi and Radiomatics to distribute their compound centrally in The U. S. From one site in the Midwest, and which certainly seems very feasible. As we look at the currently approved radiopharmaceuticals that Novartis distributes, odds are that any product injected today, for example, into a patient was probably maybe yesterday.

And the sort of the slightly longer live isotopes like Lutetium and Actinium two twenty five rely on about a forty eight hour or so shelf life. So how we think about our programs, we have a site in Iowa that’s currently producing material for the clinical trials, has been for several years now. We can get product from Iowa across the entire U. S. Right now.

We just opened up a in October, a facility in Somerset, New Jersey that we acquired from Lantheus. That site we acquired in March and started shipping doses in October. And that site is commercial ready and can ship product by ground across the East Coast and obviously by air across the whole U. S. And then as we look at our published expansion plans, we have acquired a building in Houston, a building in LA, a building in Chicago.

And so we are investing in manufacturing sites there as well with these manufacturing sites being actually pretty efficient to operate, given that they the capital requirement for each of these sites is under $40,000,000 to produce a facility that can support quite a large number of patient doses. So, in order of magnitude less than some other manufacturing programs, we have the luxury of not needing to create the isotope on-site from a linear accelerators and cyclotrons and nuclear radiation. We have the benefit of all of our isotope comes through chemical separation. And there’s a very interesting separation technology that we’ve developed just for LED-two 12, its parent region two twenty four and its parent floor in two twenty eight. And so, on-site purification or separation by washing a column is much easier technically than having a cyclotron or reactor on-site.

Peter Lawson, Biotech Analyst, Barclays: Got you. Thank you. And then maybe you’ve kind of touched upon it, but just the differentiations of your platform versus others and YLAN or A alpha?

Ed Sbor, CEO, Perspectiv Therapeutics: So, when we think about our platform, we’ve leaned in pretty hard on led T12. We think led T12 has been that sweet spot, not too long a half life, not too short, we can distribute it. But also is able to irradiate the tumor with a hard fast punch and then disappear so that the body can respond, the tumor microenvironment isn’t being irradiated. We’re not damaging tumor infiltrating lymphocytes that may be recruited into the cause. LAD-two 12 has a elemental twin, LAD-two zero three.

This allows us for early work in drug development to do perfectly correlative dosimetry using the same composition of matter and the same chemical at a dosimetry level. And so, we like those isotopes of L2O3 and L2O2. The big enabling piece for our platform is actually incorporating those into a proprietary chelator. And so, we have intellectual property around this chelator as well. The chelator is like a chemical cage that holds the metal in place and then drags that metal wherever the rest of the moi the rest of the peptide linker wants to go in the body.

And so, all of our programs so far take advantage of the fact that we can have this proprietary chelator. The chelator plus any physical linkers plus the targeting peptide together form the composition of matters that we actually also file IP around. And that overall targeting entity, the molecule with the chelator, the metal, the peptide, the linker, all those things together are what differentiates. So, we develop new programs with novel compositions targeting unique targets. If we target expresses on the tumor and doesn’t express in a lot of normal tissue, then we’ll look at that pretty accurately as a candidate.

And then, we’ll actually use this and develop assets that we take into the clinic. So, one of the nice things about our platform is that by using our expertise in cyclic peptide chemistry, we can tune biodistribution, we can tune the pharmacokinetics of the drug during discovery and try and optimize for biodistribution and then lever our experience in making these programs, scale them up, do proof of concept imaging in animals, therapeutics in animals, imaging in humans, then move from there to treating in humans as well.

Peter Lawson, Biotech Analyst, Barclays: Yes. It’s an interesting dynamic where you can kind of visualize and treat. No,

Ed Sbor, CEO, Perspectiv Therapeutics: it really is powerful. The see what you treat, treat what you see, it’s not just a great tagline. It really means you can run your you can do test runs in animals or humans without damaging them. And so, the ability to actually go so for a patient with melanoma, for example, fifteen percent of patients with metastatic melanoma should express MC1R, a target that we like. A non invasive way to identify if that target exists is to actually give the patient the drug that they’ll be getting as a therapy, but only as a diagnostic.

And so, you can do a dry run-in that patient and get perfectly predictive dosimetry for a follow on dose. And so, if a patient is injected with a diagnostic and their MC1R positive, then we know that they could be candidates for the therapeutic. If they don’t express the target, don’t treat. And that’s really nice way to go where we can actually do these things. And also, looking at biodistribution, we derisk every step.

And imaging the animal is great. Treating the animal proves localization. Imaging in a human is a phenomenal derisking point because then we can actually really see, do we get tumor accumulation or

Peter Lawson, Biotech Analyst, Barclays: do we get off target? What’s the time between so if you took that idea and if you can essentially image the patient and then could you treat them the next day or how would that work? So depending on the

Ed Sbor, CEO, Perspectiv Therapeutics: receptor and then on the patient type, it can be as quick as next day. Some receptors have a very, very high turnover ratio turnover rate and there’s so many of them that there’s no issues of occupancy. We’re doing picomolar levels of activity. And so, it’s almost impossible to saturate all these receptors. Logistically though, you want to make sure the patient is screened.

So, in theory, a patient with a positive scan could even be treated same day. But for most sites, they want to wait the next day and make sure the drug is available and ready. We try and treat patients within a week or so of a positive confirmatory scan showing that they have the receptor that we target.

Peter Lawson, Biotech Analyst, Barclays: Got you. Thank you. And I guess if we move on to the SSTR2 targeting molecule, kind of just if you run through the kind of current standing of that data and kind of, I guess, Nena dive into the FDA feedback you’ve had so far?

Ed Sbor, CEO, Perspectiv Therapeutics: Sure. So the when we actually developed this program, it came out of the University of Iowa. We wanted to develop a better drug for pediatric neuroblastoma. And so, we want to design a safer molecule for kids that end up having, we think, ideally safer product for adults too, safer meaning a broader therapeutic window. And by looking at some of the preclinical data, we sent that to the FDA and asked for a fast track designation in that post Lutetium treated patients.

And they came back to us and said, no, we could have a fast track pre litit there. So, in the PRT naive space, and that was very exciting for us. With the one condition that we meet with them after our first few patients are dosed at both two point five and five millicuries. So, we planned in advance a dose escalation design, the MTPI2 design. We can iterate through and see where the data takes us.

However, the FDA said please pause after those first few patients are dosed to five millicuries, so we can understand what the safety and efficacy looks like and then have a dialogue with you. So that was predetermined two years ago. So we enrolled patients into the trial at the two point five millicuries last December. We decided to go very quickly that we could actually a year and a half ago December to escalate to the five millicury dose. Those patients were enrolled, the first seven.

And initial results from that study that we intended to submit to the FDA represented the NANET conference in November. And since then, we’ve had an update on therapeutic results at ASCO GI, and so tracking these patients forward. What we told The Street is that once we have clarity in terms of what we’re telling the investigators about those types of escalation, we’ll then tell investors as well. And so, it’s really a matter of making sure that we develop medicines that everyone considers to be within reasonable therapeutic ranges.

Peter Lawson, Biotech Analyst, Barclays: And then, how does this stand for like cohort two, cohort one datasets? And then I think you were waiting for FDA feedback for cohort three.

Ed Sbor, CEO, Perspectiv Therapeutics: Yes. So once we get FDA clarity on what we’re telling the investigators for Cohort three, we’ll then be disclosing that. We prefer not to sort of comment on discussions in progress. But the Cohort two, the five military level, the Data Safety Monitoring Committee recommended that we reopen that cohort and we could dose up to an additional 40 more patients. And the physician interest in that has been extraordinary.

And so prior to the NETZ data and post, we had a lot of interest. We disclosed that as of December 31, ’11 more patients had come in on that reopened cohort two. And you can run through and see how long it will take for them to kind of see results. That was going to be in August and December. We are committing to doing regular updates on enrollment.

And then, we’ll see as the data matures, we can track the patients through. We can’t do a two year follow-up on a patient that only got enrolled a year ago, obviously. And so, we are watching patients all the way through and seeing how the follow-up goes and when reasonably appropriate at medical meetings, we’ll be giving updates to everyone about the progress.

Peter Lawson, Biotech Analyst, Barclays: Got you. Because what is two unconfirmed pianos within that?

Ed Sbor, CEO, Perspectiv Therapeutics: So, what we disclosed in at the ASCO GI conference was two unconfirmed PRs. And then, whenever the data is updated at a medical conference, we’ll be able to disclose the next what happened with those patients. Okay. The one confirmed response and two unconfirmed was

Peter Lawson, Biotech Analyst, Barclays: what we disclosed at ASCO GI. And all those patients are available for follow-up? Is it

Ed Sbor, CEO, Perspectiv Therapeutics: Yes. So, these are patients where, if you think about patients with neuroendocrine tumors, they it’s a very long, slow growing tumor. And so, for a while, they would have been treated with somatostatin until they started to progress. Once they started progressing, they would have come into the study. And right away out of the gate, eight out of nine patients had disease control.

And so, that gives the physicians confidence that they can actually monitor them as they would normally. As part of the study, the patients do come back every eight weeks or so for follow-up and for routine reasonably clinically relevant scans to assess their disease status. Is

Peter Lawson, Biotech Analyst, Barclays: there a good venue for the next update? And presumably that could include Cohort three or how do you

Ed Sbor, CEO, Perspectiv Therapeutics: So, we want to be really careful about not front running conference materials and things like that. So, as we’re allowed to with the various conferences in terms of commenting if abstracts have been submitted or accepted or what will be produced, we’ll be communicating that. We do like medical conferences because at the end of the day, we’re trying to inform physicians and clinicians about how this can impact their patients. And so, we like that setting as a way to have data come out. Perfect.

Okay. And then I do want to give a caveat though, which is anything that’s going to go in an abstract will almost by definition obsolescence itself by the time the data gets presented at a conference. Got you.

Peter Lawson, Biotech Analyst, Barclays: Of course. Okay. No, that’s a long lead time with these abstracts that you’re thinking of right now, okay? And I guess MC1R, I guess, why that? And we’ve got some follow-up questions about it.

Ed Sbor, CEO, Perspectiv Therapeutics: Yes. So, I mean, so melanoma, as everyone appreciates in this room, is a very, very tough disease. And I think the recent if you look at the SEER database for metastatic melanoma patients that are on diagnosis of being stage four have a fifty percent mortality after one year. And so, it’s a pretty tough disease to try and interact with a lot of energy in the space. What we like about the MC1R target is that about fifty percent of patients express MC1R with metastatic melanoma, fifty percent do not.

And therefore, it’s absolutely appropriate to try and do a screen. And what we like about this matching isotope combination is that you can actually screen the patient with the potential therapeutic to assess if they have enough receptor positivity to warrant treating with the therapy. So, there’s a clear unmet medical need in melanoma. If we look at the expected PFS of the patients that we’ve been enrolling, we’re enrolling patients in the post second line plus settings. On average, we’ve had five previous therapies that have been tried and not worked enough, so the patients were progressing.

And so, with expected PFS of two to four months, we are thrilled that in our three milligirdos cohort, all three patients went well past that timeline and at nine, eleven, thirteen months post, we still had stable disease. And so, to take a rapidly progressing aggressive disease like melanoma and turn that into stable disease, and I’ll quote our Chief Medical Officers in the audience here. It says like the disease has been frozen in time. And that’s an amazing thing to do if you’re treating a patient to have that disease frozen in time versus a reasonable expectation of rapid progression. And so, the fact that we have clear signs of activity and efficacy within what we think is a very good safety profile to actually freeze that disease.

And in fact, one of those patients turned into a confirmed response about a year post.

Peter Lawson, Biotech Analyst, Barclays: Perfect. And the where are you for the in that dose escalation?

Ed Sbor, CEO, Perspectiv Therapeutics: Yes. So, it’s dose finding more than dose escalation. What does that mean? That’s a subtle nuance, which is that we can go up or down with the design based on safety and efficacy trade offs. And what we found is that if we are dosing a five millicuries, what we think happened then is that we took to this incredibly complex system called the immune system.

And if that gets out of balance, the disease goes unchecked. And so, we didn’t want to interfere with the immune system, which we think happens at higher doses and get that optimal slightly lower dose, that three millicuries that did have a beneficial impact for the patients. And the preclinical data says that if possible, we can get a much higher response rate if we combine with a checkpoint inhibitor and an alpha emitting therapy. And so, the idea of actually going to combination therapy has been our development goal out of the gate. But we didn’t feel comfortable going into combination therapies without isolating the safety and efficacy profile of the individual components.

And so, in our case, we have an agreement or collaboration with Bristol Myers Squibb with OPDIVO. That’s been well characterized. But what’s not known is what does monotherapy look like with our drug, the alpha miter. So, now that we have a sense for what that safety and efficacy profile looks like For to avoid stacking safety signals, we’re taking a three millicurary and lower down further to 1.5. The animal data really supports lowering doses as well.

And so, we’re now actively enrolling patients in that one point five millicurary cohort in either monotherapy or combination with OPDIVO.

Peter Lawson, Biotech Analyst, Barclays: Okay. Thank you. And it was, I believe, kind of some renal accumulation of the drug. Is that something that

Ed Sbor, CEO, Perspectiv Therapeutics: So, you get normal expression of MC1R in the kidneys as well. The kidneys tend to be the path for any for almost any drug to be cleared from the body, right? It’s either going to be through the hepatobiliary system or through the renal system. And so, you do want to monitor kidney exposure very carefully. And so, we are starting to hit some calculated thresholds at the five milligram dose level that would make us really be thoughtful about watching those patients through.

And so, lowering the dose lowers the overall kidney exposure. So, we did see that there was a calculated kidney dose, but we do not see anything manifest clinically acute or chronic to imply that there are any damage to the patient’s kidneys from this. Okay. So, I want to be really careful about that because there’s nuance there. There’s calculated limits for kidney exposure that are based on historical external beam data.

So, taking a different energy form and trying to extrapolate what that could be from a safety perspective. But within this case, we didn’t see anything show up on any of the biochemical markers to imply any issues with the kinase in these patients.

Peter Lawson, Biotech Analyst, Barclays: And I assume as you kind of explore lower doses, any of those worries or concerns or points of monitoring will kind of diminish? So we have a

Ed Sbor, CEO, Perspectiv Therapeutics: strong attention to making sure we look at everything very carefully, potential heme tox, kidney tox, cardiac tox. We look at everything across the board. But lowering the dose of the radioactive material really lowers those theoretical calculations for kidney as well. And so, we found in the animal models that there are it’s more sort of parabolic shaped response curves where you want to find the right part of the curve, so you can actually get enough of the neoantigen exposure or generation to actually let the immune system do its job. You don’t want too much radiation to overload either the immune system or to cause theoretical kidney damage.

And so finding that sweet spot by lowering the doses down follows the animal data from an efficacy hypothesis while having less burden and less potential load on the patient.

Peter Lawson, Biotech Analyst, Barclays: Okay. When should we expect the next dataset? And what’s the right path for success in these patients, whether it’s the monotherapy or the combo?

Ed Sbor, CEO, Perspectiv Therapeutics: So it’s a really tough field in melanoma. We know what the PFS data looks like in the post second line plus setting. We would love to see if we can actually explore dosing patients earlier in the disease progression to allow a much greater potential potentiation of the immune checkpoint inhibitors, give the immune system something to grab on to by having this neoantigenic form generating alphas on board. When we actually think about where we’re trying to get to, the fact that we took patients with really short expected PFSs and have them extend out so far is always a big plus. We see that as a win.

We’ll follow the data wherever it takes us. What we are committed to doing is giving regular enrollment updates at our quarterly earnings and then have people track through them. The melanoma program has three doses of the drug, so eight weeks apart whereas the neuroendocrine program has four doses eight weeks apart. So there is a slightly different kind of range of time that we look for.

Peter Lawson, Biotech Analyst, Barclays: I’d love to move on to the FAP target. It was a really interesting target. How do you differentiate versus the other players within that space? So it’s So,

Ed Sbor, CEO, Perspectiv Therapeutics: I appreciate we just have a minute left here. But, FAP is a really interesting target. The stroma that forms when cancers get big enough, they have to form their own infrastructure is really complex structure. There’s competing hypotheses if it helps or hinders the immune system’s ability to go and address it. At the end of the day, no one thinks that stroma is good or beneficial in the fight against cancer.

It seems to help the tumor out. And so, taking out the stroma at the end of the day and also any tumor associated with the stroma, the stroma forms almost a web and a sponge like structure within the tumor. So, getting an alpha mating therapy into the whole complex tumor structure is a big plus. What’s really different about our approach is that we’ve actually targeted not just the stroma, but optimized the molecule, so we don’t get accumulation of other tissues. So prior FAP targeting agents have had different initial by distribution.

At the four hour mark, they’ve kind of peaked in the tumor and then they sort of moved out. And those have been really interesting imaging agents, whereas we’ve designed ours to go into the tumor right out of the gate and stay there over the half life of lead. And so, designing a therapy means hit the tumor hard and fast, have it bind and have it stick.

Peter Lawson, Biotech Analyst, Barclays: Perfect. So, with one second left. Thank you so much. Always a pleasure, Jim. Thanks, Peter.

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