Operator: Thank you. Your next question comes from the line of Ellie Merle from UBS. Please go ahead. Hello? Ellie, is your phone on mute? Ellie, is your phone on mute? Okay. Due to no response, I will go to the next question. One moment, please. And your next question comes from the line of Bill Maughan from Canaccord. Please go ahead.
William Maughan: Hi, and thank you. So, as a technology-agnostic oncology company who has not yet gotten into radiotherapy, do you see the excitement recently in that field as warranted? And if so, could we expect BioNTech to potentially get some stake in a radiotherapy combination or technology by partnership, or just bringing it internally? It seems like a lot of the deal sizes recently could be in the range that BioNtech could look at. Thank you.
Ugur Sahin: Yeah. So indeed, value immunotherapy is reaching our maturity. This is one of the aspects that we are following. We are currently not looking for opportunities for in-licensing, but some of the research that we are doing internally could go into that direction. We could talk about this end of this year when we have first validation data.
William Maughan: Thank you.
Operator: Thank you. We will now go to the next question. And your next question comes from the line of Hartaj Singh from Oppenheimer. Please go ahead.
Hartaj Singh: Great. Thank you. Thank you for the question. I just want to ask a question on the slide where you got listed the average quarterly patient enrollments. Over the last couple of years, we’ve seen actually real difficulty with companies in oncology just because of the vast number of trials going on in oncology and IO recruiting patients. And you’ve seen a really nice acceleration from 2022 to ’23 and the first quarter of ’24. So can you just put some color behind that or meat on the bone of what exactly are you doing? Is it just the ability to — the trials getting IRB approved, more trials actually moving ahead to late stage, maybe spending more patients on recruiting trials at site? Love to hear that. And then how does this change your thinking on potential readouts? I mean, it’s nice to see the improvement enrollment but how does that translate to when readouts could actually happen? Thank you.
Ugur Sahin: Yes. Let me take the first part of the question. So, in the timeline of 2020 to 2022, 2023, of course, we dealt with early clinical trials which are typically recruiting a lower number of patients, defining based on those escalations of cohorts, safety assessment, biomarker assessment and so on. And we are now reaching a phase where we have multiple trials in Phase 2 and first clinical trials in Phase 3, which naturally allow us to enroll faster and ensure that we get the statistics. This is also the reason why we now are able to move multiple clinical trials into registration trials end of this year. And for all of the registrational trials, we will provide the timelines, then we expect the readouts. As Ryan alluded, the first readout for our first potential registration trial is in endometrial cancer will be next year — second half of — or mid next year with the opportunity to get notarization end of next year.
And we will have multiple interim readouts for — to be presented at ASCO and ESMO and CIPSI this year on the currently running cohorts.
Ozlem Tureci: If I may add to that, you have pointed out quite correctly, that patient recruitment becomes more and more difficult. We are in the fortunate situation that we have a richness of different assets and thereby a design space to choose those assets and combination trials which can give us several hits on our target to become a multi-product oncology company by 2030. But it was very clear to us from the very beginning that this also means that we have to improve our capability to execute these clinical trials. So we have invested, and this is what this bar chart shows, we have invested major efforts to mature our clinical development operations, organization, and also to grow it. And we also have invested into models such as working with partners — with our partner companies to enroll into our joint trials and public-private partnership.
For example, the partnership we have with U.K. in which we are building a cancer vaccine launchpad and thereby mobilizing on a national level large numbers of clinical sites. And this is basically what this numbers reflect.
Operator: Thank you. We will now take the next question. And your next question comes from the line of Ellie Merle of UBS.
Ellie Merle: Hey, guys. Can you hear me now?
Ryan Richardson: We can hear you.
Ellie Merle: Okay. Perfect. Great. Thank you. Just for your HER2 ADC where you got breakthrough designation in endometrial cancer late last year. And I think you just mentioned you expect to have the pivotal data in the second half of next year, if I heard that correctly. Can you tell us a little bit more around the design of this pivotal study and also how you’re thinking about the opportunity for this asset in endometrial and where it would fit in the broader landscape there? Thanks.
Ugur Sahin: The currently running trial is a single-arm trial in this population. And it is — the registration will be based on safety data and response data and durability of response data. And this will be combined with a confirmatory trial for which we still are in the planning phase and we will inform in around three to four months about the design of the confirmatory trial.
Operator: Thank you. Your next question comes from the line of Simon Baker from Redburn Atlantic. Please go ahead.
Simon Baker: Thank you for taking my question. And it’s on SG&A, your guidance implies an increase between EUR160 million and EUR260 million this year. I would assume a large part of that is the global commercial footprint build-out. I just wonder if you give us an idea of how that phases over this year and also ’24 versus ’25, is most of the spend this year, always most of it in 2025? Some idea of the cadence of that build-out would be great. Thanks very much.
Jens Holstein: Yeah. Thanks for the question. You should expect for ’24 that we have slight increases quarter-by-quarter in terms of our S&M costs and the G&A costs here in ’24. And then for ’25, likely to have a further increase in the setup. Of course, you start to hire personnel for the commercialization around C force to only shortly before you launch. And that will — the timing of that will drive the spend in ’25.
Simon Baker: Okay. Thanks so much.
Operator: Thank you. Your next question comes from the line of Yifeng Liu from HSBC. Please go ahead.
Yifeng Liu: Hello. Thanks for taking my question. Just one question on your HER2 ADC in breast cancer. How do you think about the biomarker reflection there when you have HER2 low, and perhaps whether you think about HER2 ultra-low as well in the design of your pivotal study? Thanks.
