Bahija Jallal: So maybe David, thank you, Michael first for the questions, maybe David to start, and then Mohammed go ahead.
David Berman: Michael, sorry, Paul, yes. So in terms of the PRAME, we as a small company have to focus. And so what we have decided is to focus where we believe is both the best opportunity from a technical point of view, but also which is the largest opportunity. And so for PRAME, we’re focused on first line. In the late line setting, where the PIWIL was recently approved, that’s where we have KIMMTRAK in an opportunity, and that trial is approving well. And that trial has a survival endpoint, which will lead to a full approval, whereas the recent PIWIL was an accelerated approval. With regards to the lung question —
Bahija Jallal: Yes. Mohammed, do you want to take that?
Mohammed Dar: Sure, happy to do that. So with lung, we know it’s a very heterogeneous disease and there’s distinct molecular subsets. So based on well-known and well-described subsets, the cohorts that David alluded to that we’re exploring are sort of run along those lines.
Operator: Thank you. Our next questions come from the line of Graig Suvannavejh with Mizuho. Please proceed with your question.
Avantika Joshi: Hi, this is Avantika for Graig. Congrats on the quarter. I just had a question on KIMMTRAK. It appeared that the ex-U.S. sales were a little bit flat I would say. Is there a reason for this? And how do you intend to keep growing this? And how do you also intend or how much more growth do you see in the U.S.? Thank you.
Bahija Jallal: Thank you, Avantika. Ralph, you want to take this one?
Ralph Torbay: Avantika, thank you for your question. So, look, we’ve had a very successful set of years, a couple of years in Europe where we’ve launched in Germany, France, significantly, but as well as Italy and six other countries. So we’re really at this phase where we’ve established KIMMTRAK as standard of care and we are well penetrated. So we do see a relatively flat future with some of the launches incrementally adding to the growth there. Now, the primary driver of growth will be the United States, and that will be driven really mainly by us continuing to penetrate into the community and identifying patients earlier.
Bahija Jallal: And as you know, in Europe it’s about country-by-country for pricing, and so that we’re continuing that.
Operator: Thank you. Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question.
Peter Lawson: Great. Thank you. Thanks for taking my questions and congratulations on the quarter. Just as we think about revenues this quarter, kind of what drove the growth in the U.S. business? Any one-timers we should think about and any guidance around how we should be thinking about 1Q.
Bahija Jallal: Great, Peter. Great question. Ralph?
Ralph Torbay: So, Peter, we had a great 13% quarter-over-quarter growth in the U.S. The main driver for that, if you recall, at the beginning of the year, we said we’re going to be focusing on the community and that community penetration, and that’s what we did. Now the majority of our scripts are coming from the community and that’s what’s driving really the main part of our growth. We’re also seeing duration of therapy in sustained with positions really be on progression. So what we expect in 2024 is the growth to incrementally continue into the U.S. And beyond 2024 in the mid-term, we’re expecting, as David has mentioned, TEBE-AM study data, as well as in the long-term, the ATOM trial, which we’re very excited about.
Operator: Thank you. Our next question comes from the line of Jack Allen with Baird. Please proceed with your question.
Charlie Moore: Hi, this is Charlie on for Jack. I was just wondering if for the ovarian in the PRAME franchise would you be able to give us a little more color in terms of the size of the data set you’re expecting, as well as duration of follow-up and what you would consider the bar for success there?
Bahija Jallal: Great, Jack. Thank you. David, you want to take this question?
David Berman: Yes, Charlie, the — with regards to size, as we haven’t been commenting on a number of patients, but what we have said is that we will show data that is sufficient in order to inform the level of activity, and the duration of follow-up, we believe will also be sufficient. In terms of the bar for success, we’re looking at answering two questions, which is traditionally what we do in drug development is the drug active and does that clinical activity support registrational additional trials, so we know the drug is active. And then here in terms of clinical activity, we’ll be looking at partial responses, durable tumor reduction, PFS, disease control, and of course, ctDNA reduction, which is emerging as a consistent theme for our platform.
Operator: Thank you. Our next question comes from the line of Jeet Mukherjee with BTIG. Please proceed with your question.
Jeet Mukherjee: Hey, thanks for taking our question. This is Jeet on for Justin. Was hoping you could just help us think about the efficacy bar for relapsed free survival for the adjuvant setting, and just any thoughts around the neoadjuvant setting as well for uveal melanoma. Thanks.
Bahija Jallal: Great, Jeet. David, you want to take this one and maybe you can comment as well, Ralph?
David Berman: Yes. I’ll focus on the neoadjuvant first. In the — interestingly, in the original trial, when we looked back, we did have a couple of patients with residual melanoma in the eye, and interestingly, when we looked at those lesions, there was actually reduction in those tumor lesions. So I think neoadjuvant is an exploratory program, and we have a couple ESRs with regard to that. In terms of your first question, which was the — what is the bar for success in terms of relapsed free survival, what would the control arm be? This is a high risk population.
Bahija Jallal: And I think Mohammed can comment on that.
