Aptose Biosciences Inc. (NASDAQ:APTO) Q4 2022 Earnings Call Transcript

Soumit Roy: All right. So how are you thinking of presenting the data midyear or later second half also? Are you going to do with this from the APTIVATE trial, like the traditional or response rate or CR rate over a number of patients treated? And alongside you’re going to show long term, if any, durability data from the dose escalation expansion part of the trial?

Rafael Bejar: So traditionally, we have done that kind of more complete update at major medical meetings like EHA and ash, and I think that that will definitely hold true for ASH. I do think that EHA will be a more incremental update. So there may not be that much level of detail just because to be honest the cut-off date for data to present at EHA is about now. So we won’t necessarily have a lot more to say than we have said earlier this year in that regard. So we will do an incremental update. We’ll certainly highlight any activity or issues that arise in the study around EHA, but expect that larger data package with some of the more detail that you just described to have on later in the year.

William Rice: Just to add to that, we will have certain scientific findings at EHA that we’ll be presenting. That’s the plan as well as some of the additional data as you said, as we follow some of these patients that have been on the dose escalation dose exploration, we’ll be able to provide that. But then as Dr. Bejar said, we just started the APTIVATE trial and we’ll present the data that are available. It won’t be a huge number of patients by that time, but we’ll present what we have.

Soumit Roy: Thank you, and congratulations on all the progress.

Operator: Our next question comes from line Joe Pantginis with H.C. Wainwright. Your line is open.

Joe Pantginis: Hey guys, good afternoon. Thanks for taking the question. So Bill was wondering maybe if you could do a little benchmarking for the audience about your regulatory plan for the monotherapy arm in APTIVATE, you talked about, since it’s mono, potential accelerated approval. So, based on your internal thoughts, regulatory consultants or what have you, can you benchmark how many patients do you think you’ll need for the FDA to be happy with? And more importantly, can you benchmark essentially a response rate or a CR rate to beat?

William Rice: Ah, boy, number of questions there. So first of all, I’m not going to go too much out on a limb because soon we are going to be having the FDA and we’ve already articulated that to the street. So we’ll be speaking with all the parameters you just mentioned for the monotherapy as well as the doublet data that are coming out. We want to make sure that as we go to the FDA, by then, we will have a number of patients that are already on the monotherapy, the APTIVATE trial, make sure that we’re doing everything that we should determine if there are additional parameters we need to measure, so that when we go to them with the data later in the year, we’ll have everything that we need and hopefully the data will be supportive of going toward a an accelerated approval, whether that’s a monotherapy, a doublet, we’ll see how those data emerged toward the end of the year and Raf, is there anything else that you wanted to add to that in terms of regulatory?

Rafael Bejar: No, I think that’s a good way to put it. I think that we do need to have that meeting with the FDA to really align ourselves, and depending on what features we agree upon that, that’ll change the scope of the study. But certainly an accelerated proof of study would be a much smaller study than you would have to do if you did a randomized multi arm study.

William Rice: Yeah. And then also a little bit later in the year, as we collect data on the doublet we want to be able to go to the FDA, present the data there, and hopefully have the ability to move into the triplet trial. Does that answer your question?