Good afternoon, everyone. Thanks for joining Jefferies Healthcare Conference in London. My name is Clara Dong. I am one of the Jefferies biotech analysts here. I am joined by Immunocore team, the Chief Executive Officer Bahija Jallal and Chief Financial Officer Travis Coy. Very welcome.
Thank you.
Thanks, Clara.
Maybe we can start off by having a brief overview of the company, what Immunocore is focusing on, what's your pipeline?
Sure. First of all, thank you for having us. Immunocore is a commercial- stage biotech company that's here in Oxford and in the US. We pioneered the first T-cell engager platform. Our platform basically is also really modular that can either increase the immune system or modulate up the immune system, and that serves in oncology and infectious disease or down- modulate the immune system in autoimmune. We validated this platform not only in the clinic, but also in the market with our first product, KIMMTRAK, that's in uveal melanoma that was approved and now approved in 38 markets, and we are launched in 28 markets. After that, with that, I think we are also now using KIMMTRAK in two Phase 3 trials as our life cycle management, one in cutaneous melanoma and one in adjuvant trials. These are two Phase 3s.
We have, with the success of KIMMTRAK, we have another product, which is PRAME, that's also in Phase 3 in first-line cutaneous melanoma. Behind that, we have a full pipeline of mid-stage, and that's what we are really focusing on is to continue to advance the pipeline.
Great. Before we move to talking about KIMMTRAK and PRAME bispecific and your broad pipeline, maybe just take a step back. I want to talk about your platform first. I mean, obviously, you are a pioneer in T-cell receptor therapies. How is your platform differentiated maybe versus some of your peers? Maybe what's your vision for where this platform is headed to?
Yeah, so thank you for the question. Our platform, like I said, we were pioneers, so we had to invent everything ourselves. We have a full library of HLA–peptide that we had to actually do ourselves with the mass spec and all that. We have obviously the CD3. That was every single step of the drug development we had to invent and do ourselves. I think the differentiation, the best differentiation we can have is really with KIMMTRAK that's on the market, right? That's the ultimate differentiation and ultimate things. I think there are still more things that we are learning, us and the field. The important thing in the platform is the fact that it is modular.
We have on one side the HLA–peptide, the TCR that binds to the HLA–peptide, but on the other side, we have an effector. The first one is CD3. That's what we validated now. In autoimmune is a PD-1 agonist. That gives us a whole possibility, I think, to talk about the vision to the future that we can modify that effector as we wish. I think we're learning a lot there.
Great. I want to start our conversation with KIMMTRAK, your commercial product. KIMMTRAK has been on the market for over four years and, as you said, approved in over 20 markets worldwide for treating uveal melanoma. Maybe just walk us through the commercial performance of KIMMTRAK right now. I would love to hear a little bit of your comments about how you think about the growth trajectory of KIMMTRAK as well.
Sure.
Yeah, happy to. Thanks, Clara. So we're very pleased. In the last quarter, we had an exciting milestone where we exceeded $100 million of sales for the first time in the commercialization of KIMMTRAK. We continue to be pleased with the commercial momentum we've had there. That growth has come from both US and OUS. In the US, we're about 68% penetrated right now. We continue to drive growth from both moving into the community setting and increasing that penetration, as well as seeing increasing duration of therapy. Coming from two different aspects. OUS, the growth is really coming from incremental launches as we continue to expand the access to patients globally. Most of the growth there, we're pretty highly penetrated in several markets, OUS. A lot of that growth is coming from recent launches such as the UK, Netherlands, Poland, and other areas.
I also want to talk about a key metric of the adoption here, the duration of therapy. Where do we currently stand on this metric? Do you see any potential to even further extend the duration of therapy?
Yeah, this has been one of the most, I think, remarkable things we've seen about KIMMTRAK, and it really speaks to the benefit it brings patients. We're now at about 14 months duration of therapy. In the clinic, we saw about 10-11 months. This is a very unique situation where the duration of therapy in the real world has actually extended beyond the clinical setting. I think there's a lot of aspects of KIMMTRAK, including the safety profile, that have allowed that to occur. That has also been beneficial in helping us push into that community setting, that safety profile and the comfort physicians have with not having cumulative toxicity and other things.
Yeah. I would just add, in uveal melanoma, the people were supposed to live 12 months maybe maximum. Today, we have patients that are alive five, six, seven years from now. That's really thanks to the profile of KIMMTRAK.
Maybe just to follow up on this point. Does the duration of therapy differ across the regions where KIMMTRAK is approved? Is it also similar in the community settings versus academic settings as well?
Yeah, we actually see a consistency. Frankly, we have now enough data in France and other regions where we see the same duration of therapy. That, again, I think that again speaks to the profile of the drug. That has been very, very consistent so far. I think we also published the data for three years. We have three years. Next year, we will publish the data for five years after launch. There will be also more data from the real world, which I think is really exciting.
Great. We're definitely going to talk about the opportunity in cutaneous melanoma, as you mentioned, adjuvant setting as well. Just in uveal melanoma indication alone, what's the opportunity there? What's the peak opportunity do you think that will?
Yeah, if you think I mentioned the roughly 68% penetration in the US. If you look at some of the markets in Europe, like Germany, France, we have upwards of 80% or 90% penetration. That is part of the reason we have conviction that we can continue to push that penetration in the US. One caveat I have to say is in Europe, they are single payer system. It is a little bit easier and less dispersed than the community setting is in the US. That is why we are focused on pushing that penetration in the community setting as we continue to push for continue to grow in the United States.
Great. Let's turn to label expansion opportunity for KIMMTRAK and the cutaneous melanoma. Why don't you talk about how's the study going for cutaneous melanoma? How's enrollment going? How large is the opportunity there?
Yeah, so the trial is a Phase 3 trial, I think, in cutaneous melanoma. This is on the setting of the third line. There is a huge unmet medical need. There is nothing approved in that setting. We had the reasons to believe, if you will, was when we compared, we did the Phase 1 with or Phase 1b with 60 patients. And we looked at one year OS. One year OS is 55%, no matter what comparators we looked at, and we had 75%. That is how we launched then the Phase 3 in that setting. We are on track to finishing the enrollment in the first half of 2026 with hopefully this is an OS- driven endpoint. That means it is going to be event driven. We should be having as early as the second half of 2026 the data from the Phase 3.
Great. Can we also talk about the adjuvant setting as well and what's the latest progress?
Yeah, so adjuvant is really something very, very close to my heart because these patients, once they are basically the primary tumor is taken, 50% of the patients are high risk. So 50% will probably develop a metastasis. They don't know. They have to just basically right now, you basically wait and you watch and wait as they call it or worry actually. So you do every three months, you have to go for control to see if there are metastases or not. The metastasis in this case is usually into the liver, which is pretty nasty. So our value proposition here is to really use KIMMTRAK when hopefully it's just the cells are seeding at the beginning and then avoid for these patients to even get metastasis. So that's the trial.
We were very happy to do the trial with the EORTC, the European Organisation for Research and Treatment of Cancer that has done all the adjuvant trials in cutaneous melanoma. We work very well with them. The trial is going well. They enrolled, they opened all the sites in Europe. Right now, we are actively opening sites in the US. The enrollment is going well.
Just to confirm, your adjuvant melanoma trial, the trial is well aligned with the European Regulatory Agency as well. What about the cutaneous melanoma trial?
The cutaneous melanoma, I'm just trying to understand the question, sorry. We are everywhere, right? We have sites everywhere. We have sites all over the world in the trial for the Phase 3.
Okay. Got it. All right, let's move on to PRAME BiSpecific. Maybe first give us a quick overview of this program and where you are with PRAME BiSpecific right now.
Yeah, so after KIMMTRAK, we had PRAME was the second cancer antigen that we developed. We showed monotherapy activity. First of all, it's really an important target because I told you in uveal melanoma, for instance, 50% will develop metastasis. One of the molecule or one of the gene that is tested is PRAME. If you have PRAME, you're going to do worse, basically. The attractiveness about the target is not only that it's highly expressed, but it's also expressed in multiple tumors, not only in melanoma, but also in ovarian, lung, breast, and so on. We were two years ago or something like that went into the clinic. We have basically showed monotherapy activity in cutaneous melanoma. We have a Phase 3 trial that's ongoing in first line in combination with Nivolumab. That trial is ongoing.
We did have what we call the Project Optimus, where the FDA in the Phase 3 asks for basically to start with the two doses and then drop one dose and continue. Basically, we needed to reach that number of patients. We did that in November. We had the IDMC. We are blinded to the trial. The IDMC chose the dose. Now we dropped one dose and we're continuing with the highest dose, basically the Phase 3. That's ongoing. Obviously, we are doing other experiments than in ovarian. In ovarian, we've shown that there is monotherapy activity, but we needed also to go in combination and earlier. That's ongoing right now and we'll have data next year. In lung, we are in signal searching. We'll have data also next year.
We came also with PRAME half-life extended, basically because we are going to go in combination. That was very important. That program is in the clinic right now in dose escalation. We'll have data also next year. Next year, just to summarize, we'll have the Phase 3 that's ongoing, but we'll have the totality of the data on ovarian, lung, on HLE, and then we can make a decision what's the next step and which molecule to take forward.
A lot of milestones for your PRAME franchise. Maybe just to take a step back for your Phase 3 first-line melanoma study. Maybe can you talk about what are the existing clinical evidence to support your confidence in this trial?
We showed with the KIMMTRAK that basically the overall response rate, or the ORR, underestimated the overall survival. We had an overall survival with hazard ratio of 0.51, which was really remarkable. When we looked at PRAME, we obviously took into account all that, right? Not only the ORR, but also the disease control and the totality if we compare to what's out there, either Nivolumab or Nivolumab plus LAG-3, that we had a convincing disease control rate to move forward. It is really we have two, basically we are combining two active agents, Nivolumab plus our compound PRAME. My belief is that we will have not only an additive, but maybe, hopefully, a synergistic effect as well. That is the experiment we are running right now.
Great. How's the enrollment going so far for this trial? When might we expect the earliest data readout?
Yeah, it's going really well. I think when we, like I said, we dropped one arm. We're going to go only with two arms, which is good. That's going to be, right now, we are in 200 sites around the world. To recruit is going really well. I think it's a little bit too early to say the trajectory, but if I had to guess today, it will be around the end of 2027, beginning of 2028 if it spills over to 2028. That should be if we continue going the way we're going right now.
Maybe just I know it's still it's more like a 2027 event, but then maybe when we talk about the PRAME and Nivo combination in front-line melanoma, what kind of data will constitute a success for maybe a clinically and commercially meaningful outcome?
Yeah, I'm not going to get into the statistical and what we have. However, having been, you want to have something that's not only statistically significant, but also clinically meaningful. Usually what we put on ourself is that something that's better 30% over what's out there.
Great. Maybe let's move on to the other important part of the franchise, infectious disease and autoimmune. I mean, you just reported some Phase 1 data in hepatitis B at the liver meeting. Maybe first, can you walk us through the infectious disease franchise a little bit? What's the program here? What are the key highlights you presented at the liver meeting?
Okay. You want to take it?
Yeah, yeah.
All right.
Happy to.
To answer your first question, Clara, on an overview of the infectious disease program, we have two efforts going on, one in HIV and one in HBV. As you just mentioned, we released data about a couple of weeks ago at AASLD for our single ascending dose data on the HBV program. We had four doses. Of the two highest doses, we actually saw four patients reduce the surface antigen, so hepatitis B surface antigen, below a 0.2 log threshold. That was the metric for what we believe is seeing encouraging doses. We are very encouraged. We saw a dose response with that data from a single dose. It continues to give us validation alongside the HIV data that are of the modularity of the platform and its applicability in infectious disease.
I think just to add to that, if you think about our goal in HIV and why we're going to HIV or HBV or infectious disease altogether, it is to really have a functional cure. If you are in because we have a very, very potent platform. We are bringing the T cells to kill the tumor cells or the infected cells. We know in HIV, for instance, while people can live with their HIV, the antiretroviral work really well. What we are after is that reservoir, where the virus hides, basically. Because our platform is very potent, we can go into these reservoirs that are very, very finite. They're very small. We can go there hopefully and then have a functional cure. That's the value proposition that we have. That's what we're testing in the clinic.
Assuming if we continue to see positive data there, what would be the next step?
First of all, we'd be super happy. I think that validates that the platform is really modular. I think it's great. I think what we said, we want to get to the proof of concept. At that point, we can decide actually to partner with the people who do that for the living, if you will. It's really important for us to show proof of concept first.
Great. Maybe if we can spend a minute or two on your development in autoimmune as well. Maybe tell us what's your vision here. What's the significance of tissue-specific down modulation of immune system? Maybe just walk us through this concept for folks who might be less familiar.
Yeah, so I think so there, I'm really excited about the autoimmune because for again, we want to do something transformative, right? Like we did in cancer and hopefully we'll do in infectious disease. What could be transformative is that instead of going as a slash hammer and really down modulating the immune system everywhere, can we do it in the organ, the specific organ where the disease is, for instance? As an example, we have the first program to get into the clinic is a type 1 diabetes. We know that in the pancreas, the type 1 diabetes, you're killing beta cells. The T cells kill the beta cells. Our value proposition there is can we go specifically into the pancreas and actually inactivate these T cells? We have a PD-1, which is the opposite of the cancer. We want to inactivate.
We have a PD-1 agonist. On the other side, we have a preproinsulin, so something that's very specific to the pancreas. That's really the value proposition. Can we go instead of having the sledgehammer, going very, very specific? We will be testing that next year in the clinic with the type 1 diabetes. We have a CD3 as another program coming in atopic dermatitis. How we're thinking about it is we have to do programs that we would know very early in Phase 1 if it's working or not, right? With type 1 diabetes, we'll be looking at the C- peptides, for instance. We will have very clear does it work or it doesn't work. If it works and if we are right, I think all the preclinical data really shows that we are right. The ultimate truth is in the clinic.
If we are successful in the clinic, then the sky is really the limit because there are so many things in autoimmune that we can attack.
Are you also open to partnership opportunities for autoimmune franchise as well?
We will be. We're always open, right? I think you have to always be open to collaborate and bring these medicines to patients faster.
Great. We have definitely talked a lot about your pipeline here. Maybe just to recap, what are the key milestones that investors should be looking forward to in the next few months and next 6 - 12 months?
One is good Christmas for everybody, hopefully. For 2026, we'll be looking at hopefully finishing the trial with the cutaneous melanoma with KIMMTRAK and then hopefully data by the second half. We're very much looking forward to the HIV data. We'll have some HIV data at that point. We'll have the HLE PRAME data as well as the ovarian and the lung data. Very busy year. We're very much looking forward to continuing also our Phase 3 enrollments.
Remind us of your cash position here.
Yeah. As of the end of Q3, we had $892 million of cash. We are in a very strong financial position. Obviously, that's enabled by continued execution on KIMMTRAK. That's also from making sure we're disciplined on the SG&A side and data-driven on the R&D side and making sure those investments have the right data behind them.
Great. That brings us to the end of our discussion. Thank you, Bahija and Travis. Thank you, all the audience, for joining the session. Enjoy the rest of the conference.
Thank you.