And specifically, where they’ve kind of looked to position it, would be kind of after the patient has had a CDK4/6, perhaps after they’ve had another agent that’s also involving an endocrine therapy, and then kind of using it in that in the pre-chemo setting. So that would be where we’d be positioning it. You had a follow-up question as well?
Divya Rao: That’s helpful. I just wanted to know, just given the other areas that are being developed, like how do you – and the KOLs, like how do you define success in this trial if it is a single agent trial in this setting?
Alan Auerbach: Yes. So I don’t know if the trial will be alisertib alone or alisertib plus endocrine, that would obviously be an easier trial to do like alisertib plus endocrine against placebo plus endocrine. So it’s a well-designed, well-controlled trial. You’re correct. There’s a lot of other agents, a lot of the ADCs, especially, but that tends to be in more of the chemo and post-chemo setting, not this kind of pre-chemo setting. In terms of what success would look like. There is a good – excuse me, there is a good precedent here in ER-positive HER2-negative breast cancer for a targeted agent being developed in the pre-chemo setting, which is PIQRAY, which is the PIK3CA mutation drug. And so, I think that kind of playbook, if you will, would be – what we’d be looking to do, which was developed in a pre-chemo population, it was PIQRAY plus endocrine against endocrine alone, that type of design and that type of outcome would be what we’d be looking for.
Divya Rao: That’s really helpful. Thank you so much.
Alan Auerbach: Sure.
Operator: Thank you. Our next question comes from the line of Gena Wang with Barclays. Please proceed with your question.
Harshita Polishetty: Hi. Good afternoon. This is Harshita on for Gena. Thanks for taking our questions. A couple of quick ones, perhaps for Alan. Alan, for the 4Q FDA meeting for breast cancer, did you already request the meeting?
Alan Auerbach: Yes. Meeting is requested and has been scheduled. It’s either this month or next month. I can’t remember which one.
Harshita Polishetty: Perfect. Thanks for the clarity on that. And then second, I have a question on – and I understand you provide very detailed guidance in the quarters to come and for the full – 2023, you’ve provided guidance. But as alisertib, you’re starting the small cell lung cancer trial and then the breast cancer trial will probably potentially start in 2024. Are you able to provide any color right now on how we should see like expenses changing with regards to R&D? Any color you can provide on that would be helpful.
Alan Auerbach: Yes. So from an R&D perspective, remember that we still have some neratinib R&D items on – in the forecast, which is we’re still closing down a lot of the previous sites, so those have to come out. And then there is a – in Europe, we had a post-approval commitment study, which was a study of neratinib using – it basically was similar to the control study, but being done in the European population. So as neratinib an extended adjuvant looking at all the different ways of reducing the diarrhea. That study will be concluding shortly, and so the expenses from that will be coming out as well. So we do have a lot of R&D budget items coming out. You’re correct going in, we – coming into the expenses would be the alisertib small cell lung and HR-positive breast.
We had gotten a question earlier, and I think we got one at one of the conferences as well on that. And what we had said was, listen, it is very important to us that we continue to be a net income positive company. So if we have to stagger the development of the drug in order to do that, then that’s what we’re going to do. We completely recognize our responsibility to shareholders, not just in developing new drugs, et cetera, but also our fiscal responsibility. And so, we think that is something very important is being able to be a net income positive company. So if we have to stagger the expense, stagger the trials in order to do that, that’s what we’re going to do. But our commitment is to maintain net income positivity.
Harshita Polishetty: That’s helpful. Thank you, Alan. And I just have one last quick question. Are you able to disclose how many sites you anticipate on opening for the small cell lung cancer trial, I mean, small cell – yes, small cell trial?
Alan Auerbach: That is a good question. I apologize I don’t have that number in front of me. My ballpark memory is like 10 to 15, if I remember, maybe 20, somewhere in that general range, 10 to 20.
Harshita Polishetty: No worries, still helpful. Thank you so much.
Alan Auerbach: Sure.
Operator: Thank you. This concludes our question-and-answer session. And I would now like to turn the conference back over to Mariann Ohanesian for closing remarks.
Mariann Ohanesian: Thank you for joining us today. As a reminder, this call may be accessed via replay at pumabiotechnology.com beginning later today. Have a good evening.
Operator: Ladies and gentlemen, thank you for participating in today’s conference call. This does conclude our program. Thank you, and have a great day. You may now disconnect.
