BioNTech SE (NASDAQ:BNTX) Q4 2022 Earnings Call Transcript

The second is indeed using this as a combination partner. We believe that anti-CTLA-4 is well tolerated, is also an excellent combination partner, particularly for our cancer vaccine pipeline. We have demonstrated in the past synergy of our personalized vaccines with anti-PD-1. But we believe that particularly for some type of vaccines we would also see synergy with anti-CTLA-4 mechanism. So the third question that you have addressed is how we define focus. We define focus in the setting that we would like to address two key goals with regard to personalized cancer immunotherapy. On the one side, personalized cancer immunotherapy increasing the overall response rate and activity in a same indication, but also in the second way personalized cancer immunotherapy allowing to provide clinical benefit with our portfolio to patients along their disease journey, meaning from the very beginning of the disease as well in the late stage.

And this is what drives the selection of the compound — compounds as Ryan said one key aspect is the compound going to add — additional close gaps in our portfolio. And the second is the compound going to increase the impact of our compound’s synergistic effects.

Operator: And the next question comes from the line of Matthew Harrison from Morgan Stanley.

Matthew Harrison: A couple PCV-related questions for me. First, just on timing. I just wanted to confirm, previously, I think you had talked about first half of ’23 for that data on the slide that says 2023. I just wondered if there was a shift in the timing or not. And then second, as we think about the outcome of the study, could you just talk sort of broadly about how we should — what kind of expectations we should have for that study and what you would deem as a positive result. And I ask it sort of in the context that for some mid stage trials, a p-value that’s greater than 0.05 can also be deemed as something you might move ahead with. So, could you just talk about that? Thanks very much.

Ryan Richardson: Thanks, Matt. So, I’ll take the first part and then perhaps Ugur can take the second part on the interpretation of the data. In terms of the readout, so you’re correct that we have broadened — actually JPMorgan, we broadened the readout timing expectation to full year 2023. So, I think it’s fair to say that that could come in the second half.

Ugur Sahin: Yes. And the second is related to how to interpret the outcome. The clinical trial is intended to evaluate the potential activity of a personalized cancer vaccine in combination with PD-1 in advanced metastatic stage setting. We would assess the activity of the compound of cost in the — for melanoma and the melanoma went from a single IO indication into a constellation there — now several combination trials — combination compounds are approved. So, that means a potential positive result would be seen also in the context of what is the residual medical need in this indication and how big is the bar to continue in the first-line melanoma setting. The second indication is that a positive trial in the first-line metastatic setting would also trigger potential additional indications in the first line in combination with checkpoint blockade.

Operator: Thank you. We will now go to our next question. And the next question comes from the line of Akash Tewari from Jefferies. Please go ahead. Your line is open.