Cue Biopharma, Inc. (NASDAQ:CUE) Q4 2022 Earnings Call Transcript

Dan Passeri: Yes. And so it’s a really important question, Ren. And it’s one that we obviously are looking at very seriously and dynamically in the various factors we have to consider. So for instance, you just mentioned monotherapy, maybe the more attractive ones since it is monotherapy direct path forward. It’s primary readout is the — is basically median overall survival. We have to follow patients. Also bear in mind, it’s a smaller market. And so part of countering that is in the front line, which is further upstream broader market of patients, we’re seeing these very promising results. So by essence of the promise of those results, we would be potentially shrinking that downstream market even further. So — and what we’d be measuring there is you probably would be overall response rate, clearly, we’d be following median overall survival, but it’s a broader market.

And we’re also looking at moving even more upstream there with the neoadjuvant adjuvant setting, for instance. So these are kind of the various factors we have to consider. And it also has to do with the capital access that we have, whether it is through a partnership, if we’re doing it ourselves, we have to think about the size of the study and the duration of that study. So all of those variables are being considered. I think the important take home for us right now at this point in time is we have the prospect of more than one potential registration path to choose from.

Reni Benjamin: Fair enough. Thanks very much for taking the questions.

Dan Passeri: Okay. Thank you, Ren.

Operator: Our next question call comes from the line of Mark Breidenbach with Oppenheimer. Please proceed.

Mark Breidenbach: Hi, good afternoon. Thanks for taking our questions. Just some timing questions for me to make sure I heard you guys correctly. We should be expecting the next data both from the CUE-101 combination study in the second half of this year as well as the initial data from CUE-102. So first of all, is that correct? And second, what should we expect in the CUE-102 data? Is it just be safety and PK data initially? Or should we kind of expect a more complete analysis of the dose escalation cohorts from that? And I have a follow-up.

Dan Passeri: Sure. All right. Thanks, Mark. Appreciate it. So the first question, just to clarify, when we said the second half of the year, that’s the sort of completed analysis or the analysis of the completed 20 patient expansion. The next update we’ll be providing is at an upcoming oncology conference. So that could be midyear. We’re not going to wait until second half of the year to release an update. So what we’re referring to the second half is that’s all 20 patients completed surveyed, et cetera, a more deeper analysis. So I hope that’s helpful. We’re looking at an update probably midyear at a cancer conference. And then regarding the metrics on 102, I think the way you couched the question that’s actually the answer is we’ll be doing the dose escalation, completing that by midyear, and we’ll be providing the corresponding metrics that we’ve been measuring along the way, which, in fact, has to do with PK/PD, a possibility, obviously, of some clinical activity as well.

And that’s going to be midyear, second half of the year. Matteo, I don’t know if you want to add anything to that? If not, that’s fine.

Matteo Levisetti: No, that’s fine. Nothing to add.

Mark Breidenbach: Okay. That’s super helpful. Thanks for that clarification. And then just maybe one for Anish on CUE-401. I’m just wondering if you have any plans to present head-to-head preclinical comparisons versus some of the other IL-2 muteins that are out there? Is that something that’s on the agenda for 2023?