Good afternoon, everyone, and welcome to the Morgan Stanley Global Healthcare Conference. I'm Sean Laaman, US Head of Midcap Biotech Equity Research here at the firm. 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. For this session, we have Immunocore, and we're joined by their CFO and Head of Corporate Development, Travis Coy. Welcome, and thank you for your time today, Travis. Maybe just to commence proceedings, we've got a couple of macro questions here we've been asking all our companies. The first one is, you know, with China's rise in biotech innovation, how are you thinking about Immunocore's competitive position here? Will this influence your R&D and business development strategy? Yeah, first of all, Sean, thank you for having us. We appreciate it. You know, China, it's interesting, they've made great strides in biotech. I think in particular areas where it's been noticeable, especially has been in immunology and cell therapy and accelerating innovation in those aspects. From an Immunocore perspective, our competitive advantage has been, and where the company has been developed around, has been a TCR platform. We need to make sure we're not complacent. Right? As we look at making sure we're staying on the cutting edge of science, we want to make sure we're not complacent with making improvements to that platform. As we look across the globe, the development of technology is not always inside our four walls. Right? China is certainly an important part of that. We view China as both a competitive aspect as well as an aspect of opportunity. I think it's both. Wonderful. Thank you, Travis. How are you currently leveraging artificial intelligence or thinking about artificial intelligence's future disruption potential? Yeah, you think about AI in two ways. One is the incorporation of artificial intelligence into making business operations more efficient. The other is, how do we improve R&D? I think incorporating AI into business operations and making those more efficient is table stakes to be competitive in any company. From an R&D perspective, again, back to our TCR platform, which the company is founded upon, areas where we're using AI are in TCR, both target identification and in protein peptide interactions. It's particularly good in large data sets and helping us process those large data sets. That's one area that helps us accelerate drug discovery. I think other areas we use it within an R&D perspective are responses to regulatory filings, as well as kind of back to the data theme, as well as doing clinical data analyses. Those are some of the ways we can leverage AI to improve both probabilities, if you will, as well as speed. I think that over the long term, AI could have a very profound impact on our industry. That's some of the ways we're leveraging it at Immunocore. Thank you, Travis. Last question before we dig into the details of Immunocore, what has been most impactful on the regulatory front? Would it be FDA, MFN, tariffs? Anything to comment there? There's a lot of uncertainty across all those, Sean. I think we've been very fortunate at Immunocore that we haven't seen a significant impact in the near term on all three of those yet. As you think across the three of those aspects, if I was going to put one in the forefront, I'd probably say the FDA interactions. Those regulatory interactions are so important to our investments and how we make investments and how we develop assets, given the amount of capital allocation, as you know, that we put into clinical trials and clinical studies. Having clear, concise, and consistent guidance from a regulatory agency is really important for us, whether it be Immunocore or the broader industry. I see, you know, MFN and tariffs as, while important, very economic-focused policies that over the longer term, you have ways to mitigate around. Making sure, again, that regulatory guidance and making sure your investments are placed in the right way that give you certainty to approval and also speed to approval is important. Wonderful. Thank you, Travis. I've got a few other top questions here. The first one is, can you provide an overview of the company's approach towards developing T-cell receptor therapies for oncology and autoimmune diseases? Yeah, I've referenced our TCR platform a few times. What we're doing on the oncology side is using T-cell receptors to engage T-cells to help kill tumors. What is unique about our platform is it allows us to produce soluble, off-the-shelf therapies. I think that's a big advantage for us compared to some of the others working out there. On the autoimmune side, it's actually taking that same thesis or axis and reversing it. There, we're downregulating the immune system. One of the unique things we can do with the platform and are looking to demonstrate with a couple of assets is for those approaches to be very tissue-specific. That allows us to prevent or avoid, if you will, this systemic immunosuppression that you typically see with immunology assets today. We're really excited. Obviously, we were able to produce the first TCR therapy that was ever approved in KIMMTRAK. We've demonstrated success, if you will, in oncology. We still need to demonstrate success in autoimmune, but we're very optimistic about that potential. Thank you. I wanted to touch on the ImmTAX platform. What differentiates your platform from competitive bispecifics? Yeah, I'd tie it back to the off-the-shelf, high-affinity, soluble ability to produce those assets. I think the other thing, because of the way it works with HLA peptide expression, it allows us to target intracellular antigens. That gives us access to about 90% of the human proteome. That's a big difference compared to if you think about traditional bispecifics that typically rely upon membrane-bound or extracellular targets to be effective. It gives us a much broader opportunity set with which to work from as we think about target identification. OK, thank you. I might start with some KIMMTRAK questions. I'm also led to make a static little middle line at the beginning here. Going forward, I believe the KIMMTRAK growth is expected to be more moderate as the launch has matured. You can provide more detail here on how to expect the trajectory or what you expect for the trajectory from this point forward. Yeah, absolutely. Just to make sure everybody's oriented, KIMMTRAK is our product that's approved for frontline metastatic uveal melanoma. We've been on the market about four years now, and we're very, as you're alluding to, we're very pleased with the growth that we've seen to date. We generated about $192 million in the first half of this year, and that was about a 32% growth rate over the same period last year. Given that we are on the fourth year of the market and that we have established ourselves as standard of care across uveal melanoma, we do expect that growth rate to moderate a bit. This is pretty typical as a product gets into its mature lifecycle, at least in the current indication, as you alluded to. We've seen about, we see about 4%- 7% quarterly sequential growth rate the last several quarters. We expect it to moderate from there going forward to give you a little bit of quantitative aspect to how we think about it. Sure. Wonderful. I think you're at about, I think you said at Q2 it might be 68% penetration. Yeah. In the U.S., what would you estimate peak potential penetration could be? Yeah, yeah, you're right. We're approaching 70% penetration in the U.S., and that's largely being driven and coming from the community setting and our efforts there to increase that penetration. I think if you think about peak of where we could go, I think if you use Europe actually as a good proxy for that, where we have a much more, on a country-by-country basis, we have a much more centralized commercial ecosystem in Europe, right? I have to add that caveat. In many of those countries, we're 80% or plus percent penetrated, and that's why we're optimistic that we can continue to push towards that in the U.S. We believe we still have room to grow driven by that penetration in the United States. How do you think about planned launches in the Middle East, North Africa, Turkey as a contributor? Yeah, so I talked about U.S. growth. If we shift to OUS growth, it's important that we continue to expand the global access of KIMMTRAK. We were approved in about 39 countries and launched in about 28 countries. Part of that expansion is looking at opportunities where we may not be the best company as ourselves to do it, but do it with a distribution partner. That's actually what we did in the Middle East, North Africa, and Turkey recently. We recently announced a distribution agreement with ORCAN to help continue to make sure we can reach every patient. That's where most of our OUS growth is coming from, those additional launches. Sure. Thank you, Travis. I believe you're now observing 13 months duration of therapy. Can you remind us how it compares to what you observed in the clinic and what's driving the increase? Yeah, so our duration of therapy has been quite a remarkable story for us. The reason I say that is in the clinic, we saw about 10- 11 months of duration of therapy. In the real-world commercial setting, we're now seeing around 13- 14 months. It's incredibly uncommon to see that happen, to see that duration of therapy be higher than what you saw in a randomized controlled clinical setting. I think that speaks to the product profile of KIMMTRAK. We've now demonstrated a three-year overall survival rate of 22 months. The safety, and so from an efficacy perspective, is incredibly attractive. On the heels of the clinical data, that was an overall survival ratio of 0.51. From a safety perspective, what we see is one of the most common adverse events is CRS, cytokine release syndrome, because of the CD3 on the bispecific. It's anticipated. What we see after the first few doses of KIMMTRAK, that CRS drops to mid-single-digit rates. It becomes very manageable and predictable for physicians. I think part of that dynamic that we see is it's allowed us to get to the penetration that I talked about in the community. It's also allowed for that duration of therapy to go beyond what we've seen in the clinical setting. Wonderful. Thank you. Still on KIMMTRAK, but moving over to advanced cutaneous melanoma. I guess starting first with the Phase III study in second line advanced cutaneous melanoma, could we briefly talk about how advanced melanoma compares to uveal melanoma, both in terms of clinical aspects, but also in terms of the size of the commercial opportunity? Yeah. We have two, just to ground everybody, we have two lifecycle management plays for KIMMTRAK, so two Phase III s that are lifecycle management plays. One is advanced cutaneous melanoma, as Sean, you're alluding to. Part of the rationale for why we are pursuing that indication is the similarity between uveal melanoma and cutaneous melanoma. If you think about uveal melanoma before KIMMTRAK, it was an incredibly immune-insensitive tumor, very difficult to treat tumor where checkpoint inhibitors had not worked. We demonstrated superiority versus pembro as a monotherapy with KIMMTRAK. There are a lot of similar, and if you relate that to advanced cutaneous melanoma, where patients have advanced mostly off, beyond checkpoint inhibitors, right, they sort of by definition have become immune-insensitive. There are a lot of similarities in that regard. There are also a lot of similarities with GP100. That's a target for KIMMTRAK. We have very high expression rates across both uveal melanoma and cutaneous melanoma. There are a lot of good reasons to believe and why we feel we have a high probability chance of being successful on advanced cutaneous melanoma. Great. There are studies evaluating KIMMTRAK monotherapy or in combination with pembro. How is Immunocore thinking about KIMMTRAK's addressable patient population as a monotherapy versus a combination therapy with a PD-1? Sorry, Sean, can you ask that one more time? Sorry, I'm getting... Studies evaluating KIMMTRAK monotherapy in combination with pembro. Yeah. How does the company think about KIMMTRAK's addressable patient population as a monotherapy versus as a combination therapy with a PD-1? Yeah, so as Sean alluded to, the way the design of TEBI-AM, which is the advanced cutaneous melanoma Phase III, is set up is we have a monotherapy arm in KIMMTRAK, and we have a combination arm with KIMMTRAK in combination with a PD-1, and then a control arm. What we're also encouraged by is when we look at the Phase I data, what we generated with KIMMTRAK, we obviously saw strong monotherapy activity in the patient population. We also believe there may be some synergy between KIMMTRAK and pembro as well. We've been able to demonstrate that we can safely combine those two agents. We've set up a well-controlled with an overall survival of one point. It's an important part given the context of the current FDA environment. That would give you some insight as to why we designed the study that way. Given the similarities that I talked about between uveal and cutaneous previously, we think we could see benefit in both. We were able to demonstrate superiority to pembro in uveal melanoma. Because of those similarities, we think we also have a strong chance in doing so as part of TEBI-AM. We set up the study so we can evaluate both. Sure. One question I actually didn't answer that I realized you asked is one of the reasons we're also excited about cutaneous melanoma is because of the patient population that it opens up. It's an additional, so uveal melanoma has about 1,000 patients eligible for it today and HLA2 positive patients. Sure. Cutaneous melanoma adds an additional 2,000- 4,000 patients. It has the potential to provide a very significant inflection point in KIMMTRAK's commercial growth. Wonderful. You mentioned two Phase III trials, and the second Phase III trial in cutaneous melanoma. How is the Phase III adjuvant trial in uveal melanoma, or the ADAM trial, unrolling? Have you shared when we might see the next data update from that? Yeah, we initiated the ADAM trial, which is for the adjuvant uveal melanoma, late last year. It's worth noting that's being done in conjunction with EORTC. We're off to a good start. We have several sites in Europe that are up and running and enrolling. We also recently received the IND acceptance in the U.S. We anticipate we'll have U.S. sites come on board imminently this fall. We're off to a good start. We haven't provided yet guidance on precise timing for an adjuvant study just because it probably is about a three-year enrollment with another couple of years for data readout given it's an adjuvant trial. As we get to more of a steady state enrollment curve, we'll provide more specific guidance as to when we think we could have data there. Sure. It's been a really good story with KIMMTRAK in uveal melanoma and you know, bernetofusp coming to that maturity pace. With the Phase III trials coming on and hopefully it extends growth, could you map out the catalyst path for the programs? Yeah, for KIMMTRAK? For KIMMTRAK and the further indications in the Phase III study. Yeah, yeah, so for TEBI-AM, we should complete enrollment in the first half of next year. I mentioned it's overall survival, so it is event-driven. I have to add that caveat, but we hope to have data in the second half of next year. We realize there could be some variability given that event-driven nature of the overall survival primary endpoint. I alluded to the timelines on ADAM. We'll hopefully, probably three years of enrollment and another couple of years before we have data there. We'll get more concrete guidance as we get further along in the enrollment. Wonderful. Moving on to the PRAME portfolio. The Phase III PRISM study in first line cutaneous melanoma in combination with nivolumab. Could we talk about the rationale for pursuing cutaneous melanoma and the commercial opportunity? Yeah, yeah. This is our third Phase III study that we have ongoing as an organization right now. Just to orient people, bernetofusp is a PRAME-targeted agent. The reason we chose to go into frontline, this is in our frontline cutaneous melanoma study. The reason we chose to do that is based on the evidence that we saw in Phase I. When we generated monotherapy activity with bernetofusp, we saw in a patient population encouraging disease control rates that were actually greater than checkpoint inhibitors. It was also greater than NIVO plus rela, even in a combination play. Because of those improved disease control rates, we decided to move into earlier lines of therapy in combination with nivolumab. It's really the basis for why we made that. OK, wonderful. You're evaluating two doses. Can you remind us why those two doses were selected for the study? Yeah, Sean, we have a dose selection ongoing. The way the Phase III was designed for PRISM, we call it PRISM-mel, is after the first 90 patients are enrolled, there's a dose selection that's triggered. Those two doses are 40 micrograms and 160 micrograms. There's an IDMC that is a panel of melanoma experts that receives that blinded data and ultimately will make a recommendation on the best dose to continue forward. The reason we did that is as part of Project Optimist. This is the FDA's initiative to make sure oncology products are seeing more optimized dose selection in Phase III studies. We did that in conjunction with regulatory interactions. That's why it was designed and established that way. Got you. Understood. How is the Phase I-II study in platinum-sensitive ovarian cancer, as well as the signal detection in non-small cell lung cohorts progressing? Yeah, so we have three experiments going on within our PRAME franchise. Sean just alluded to one of them, which we also have, in addition to bernetofusp, we also have a half-life extended version of bernetofusp. Those three experiments that we're looking at are with bernetofusp in ovarian. We're moving in earlier lines and in combinations in both platinum-resistant ovarian cancer and platinum-sensitive ovarian cancer. Also with bernetofusp in lung, similar story, although it's more, I will say, in ovarian, we saw monotherapy activity, but not quite sufficient enough monotherapy activity to be a standalone, we thought, to be a standalone by itself, which is why we're looking to optimize that activity with combinations in earlier lines. With lung, I think it's a little different story in that it's more of a signal detection that we're looking for in earlier lines and in combinations. The second experiment is in lung. Finally, with the half-life extended version, we're exploring in Phase I that we recently initiated at the end of last year, very similar tumor types to what we explored with bernetofusp. Think melanoma, think ovarian, think lung. The reason I mention all that is we view that PRAME, all those PRAME efforts as a franchise. We'll make decisions as such as we get that data. We hopefully look forward to be able to talk about the data and next steps within the next 12 months. Wonderful. Thank you. Moving on to autoimmune. You've got single-assembly dose started from Phase I trial for people living with HBV-positive hepatocellular carcinoma expected at the American Association for the Study of Liver Disease in November. Can you talk about the treatment landscape here? Yeah, so our infectious disease efforts holistically in both HIV and HBV are focused on trying to provide a functional cure. We have set a high bar for ourselves. As you alluded to, we look forward to disclosing the single-assembly dose data in HBV later this year. As you look across the treatment landscape, when we do that, and this is similar to both HIV and HBV, the standard of care is NUKES. The challenge with NUKES is while they do a pretty good job of controlling the virus, they're a chronic therapy. If you take a person off NUKES, that virus rebounds. What we're looking to do is hopefully have a therapy that prevents that from occurring holistically and actually enables the immune system to fight the virus, the way our mechanism works. Thank you. Are there any read-throughs from the HIV study that might inform the HBV program? Yeah, a very similar objective that actually I alluded to, which is really virus control, right? I think that's the main similarity and very similar dynamics with NUKES. As patients come off, we're trying to avoid that chronic, having to have a chronic therapy. I think those are the main similarities and obviously trying to achieve very similar things across the two. Got you. Thank you, Travis. What are you looking for in the SAT data to start the MAD portion of the HBV study? I actually almost went there. I should have just answered your question earlier then. From an HBV perspective, some of the things we're looking at, it's nice that we have a very clear biomarker with HBV. You have a hepatitis B surface antigen, right? You can look at efficacy by hopefully seeing reduction in levels of that surface antigen. Other things we'll look at are, because of the way the mechanism works, we would expect to see, and this is a little counterintuitive, but we'd expect to see increases in AST and ALT liver enzymes. That is what we'd expect to see mechanistically. What we don't want to have happen is that those increases are such that we begin to see liver toxicity. We're looking to hope to see whether we've sort of threaded a needle, if you will, between efficacy and safety as we look towards that functional curve in HBV. Thank you. I guess on the rest of the early stage pipeline, there are also CGA INDs expected for type 1 diabetes and atopic dermatitis. Taking a step back, which programs in the candidates evaluating infectious autoimmune diseases are you most excited about? You're asking me to pick my favorite child. Pretty much. From an autoimmune perspective, we look forward to where we have two efforts going on there that are currently preclinical. One is a type 1 diabetes asset. Another is a CD1A asset that likely will start trials in atopic dermatitis. Hopefully, we're on track to submit the CTA for the type 1 diabetes asset by the end of the year. I look forward to being in the clinic in 2026 for the type 1 program. For CD1A, look to filing the CTA and/or IND in 2026. There is a little difference, about a year difference in timing between the two. As I think across the therapeutic areas, what makes me excited is the modularity of the platform. You heard a lot about our efforts that we've made in oncology, having delivered the first TCR-approved therapy in KIMMTRAK. We're now exploring and generating data in infectious disease. I'm really excited to begin exploring data in autoimmune. I really think that tissue-specific down modulation of the immune system could be very unique for us. Wonderful. Thank you. Philosophically, do you think building the platform sort of organically is the right way to go? Or do you see sort of in-licensing becoming an increasing part of your business? You've had a commercial success with KIMMTRAK, which is ongoing. Philosophically, how do you think about that? Yeah, we certainly are very proud of what we've developed in the pipeline and what we have today. I agree with you in that we're getting to the point as an organization where we have the capacity to potentially create additional value through business development efforts. We need to make sure we do that in a disciplined manner. We are looking for opportunities to potentially bring into the portfolio, particularly from an oncology perspective, where we have an established footprint from a development and commercial perspective and have capabilities established there. I think if you think about the areas we're looking at, it's likely oncology from an inbound perspective. If you think about more of the outbound side of the business development equation, I mentioned that established footprint in oncology. Areas that may make sense for us to partner to maximize value, depending on data and inflection points, could be infectious disease or autoimmune, given they're earlier in their development from an Immunocore perspective as a company. That's sort of how we think about the business development strategy holistically. Sure. With that sort of commercial success out there, how do you think about forward looking on OpEx and ultimately sort of cash flow and then the ability to sort of fund your pipeline to go where it needs to go? Yeah, so we have a very robust balance sheet. It's part of what enables this business development strategy that I just mentioned with almost $900 million of cash on the balance sheet. We dipped our toe in profitability in a couple of quarters. That's not our intent. I will say that. Our intent is to make sure we're making the right data-driven investments in R&D. We do expect, particularly with the three Phase III s, some increases in our R&D investments over time. If you think about the SG&A side and the commercial side of the equation, we're being very disciplined in that regard. It's been mostly flat around $40 million, $42 million a quarter for the last several quarters. We're going to continue to be disciplined there. With cutaneous melanoma potentially being our next significant indication for KIMMTRAK, we're very fortunate that we have a lot of overlap in that commercial infrastructure. We're already calling upon around 50% of the physicians that treat cutaneous melanoma by the nature of having promoting in uveal melanoma. If you think about the additional expenses we may need to make in SG&A to commercialize cutaneous melanoma, think about it as more incremental than it is in a step-wise. Sure. I guess what I'm getting at is that if you look at where KIMMTRAK has come from and you're getting to sort of a bit more of a mature phase, at least in uveal melanoma, and you're still confident you've got the balance sheet and the cash flow generation, ability to fund the Phase III trials, get those launches out there, hopefully when they come, and also fund the development of the rest of the pipeline. Yeah, that's correct. Occasionally, people ask us what our runway is. We actually don't provide guidance on our runway because we don't need to. We have the capital, particularly with KIMMTRAK's performance and success, to be able to fund the pipeline for the foreseeable future. Yeah, wonderful. I've come to the end of my questions slightly early, but there's one final one. That is, what didn't I ask that I should have? I think you covered the pipeline fairly well and fairly efficiently in a short amount of time. I think one thing I'd leave behind is we have three priorities as an organization. One is maximizing KIMMTRAK in both the current indication and in the subsequent lifecycle management place with the two Phase III s, making sure we advance and execute on the pipeline. Making sure, and I alluded to this a little bit with the China question, is making sure we are not complacent with the platform and make sure we continue to innovate for sustainable growth. I look forward to continuing to deliver on that for both patients' sake and to deliver great value for shareholders as well. Wonderful. That is an end to proceedings. Thank you for your time, Travis. It was pretty brilliant. Thank you, too. Thank you.