So I think it’s obviously a program that we’ll have data on later this year. We’ll have a submission, we hope, by — in the not too distant future beyond that and then look to get the drug approved in 2025. So that will be through an sNDA process. So it’s all, I’d say, call it an expedited pathway through some of the designations we have in hand already or some of the things that we may avail ourselves in the future.
Yigal Nochomovitz: Okay, thanks. And then when you think more broadly about the revumenib in terms of the spectrum of care in AML, both in the frontline and in relapsed refractory, and given the fact that there’s a good chance that you’re going to be initiating a pivotal trial in the frontline in combo with venetoclax. When you start to think about the commercial build there, are you making assumptions around the potential pretreatment revumenib for patients that received revumenib in the frontline in a combination setting, whether it be with [indiscernible] or perhaps even with the 7+3, including those patients in the builds for revumenib in a relapsed refractory setting? Or once they are treated in the frontline, that wouldn’t be a part of your assumption set? Thank you.
Michael Metzger: Yes, thanks, Yigal. I think our assumption is that once you’re treated with revumenib, at least from our vantage point, the way we see it today, I think once you’re treated with the — in the frontline setting, it’s less likely that you’re going to be treated in the relapsed refractory setting, again with another revumenib inhibitor. And Neil, do you want to make a comment?
Neil Gallagher: Yeah, I agree with Michael’s comments there that I think that it is a little bit nuanced because I think longer term or I can foresee situations where patients could, for instance, have either been treated and relaxed along time later on NMP1 [Technical Difficulty] positive or came to a positive market might be very exposed. But I think, in general, I agree with Michael’s points. We shouldn’t be expecting a lot of patients to [indiscernible]
Yigal Nochomovitz: And just one on axa, do you have any timelines for the IPF trial in terms of enrollment and data?
Michael Metzger: Thanks, Yigal. No, not at this point. I think we are enrolling. As you know, we started recently bringing up sites and enrolling patients, and it’s going nicely. And so we’ll have more to say in terms of milestones, both for enrollment as well as data as we get further into the year, maybe into next year.
Operator: Our next question is from Kalpit Patel with B. Riley Securities.
Kalpit Patel: Can you comment on what proportion of patients that you estimate might be eligible to receive revumenib as a maintenance treatment after induction and consolidation. I’m trying to understand if that median duration of treatment in that specific frontline setting would be higher than the nine months that you expect in the relapsed refractory setting. Thank you.
Michael Metzger: Yeah, thanks for the question. I think if I interpret your question correctly, I think in terms of patients who would be eligible for maintenance going in the relapsed refractory setting. I think if you’re getting — if you had a successful transplant, there’s no reason that all patients wouldn’t necessarily be eligible. They need to have — be stable and graft well, and I think that usually the first step in pitching the physicians, remind us of that that there’s an engraftment period. But for all intents and purposes, all patients should be eligible for maintenance. So I think that’s our assumption. And that’s, I think, been discussed with physicians on an ongoing basis. I think when you get to the frontline setting, the assumptions for long-term maintenance and how that would play out in the fit population could very well differ if you are able to get to patients earlier and treat them successfully through transplant and put them back on therapy.
I think the expectation is treat patients earlier they stay on — they do better and they stay longer and so that should change how the assumptions work on the time on maintenance in the frontline compared to relapsed refractory. We don’t have a good estimate of that yet. Obviously, we’re generating that data. But over time, we’ll understand that a little bit better.
Operator: Our next question is from Jason Zemansky with Bank of America.
Jason Zemansky: Perfect. Thank you. Good morning and congratulations on the progress. Appreciate you taking our questions. Regarding the commercialization plans for revumenib and your initial outreach, I have to imagine there’s already quite a bit of excitement across at least the more academic-focused community. But what sort of division between rapid adopters and non do you expect? How quickly do you expect maybe the more community-based prescribers to come on board as far as awareness and education goes? And maybe bolus isn’t quite the right descriptor, given patient dynamics this late in treatment, but do you expect an initial large bump in patient numbers or more of a straight line uptake?
Michael Metzger: Jason, thank you for the question. I’m going to turn it over to Steve to address your questions.
Steve Closter: Yeah, hey, Jason. Thanks for the question. I mean, there’s a lot of excitement. I think predating, coming to the company, the company has done quite a bit of research, market research, advisory boards, and that with KOLs and the field medical team has been out there. So there’s a lot of, well to say, demand that’s there because of lack of treatment options. I’ve recently — I actually was out in New York yesterday at Cornell and and meeting with KOLs, so they’re ready for the drug. Literally cannot wait till it hits the market. So I think certainly the academic centers, Jason, there will be quick uptake. They are ready for this product. Awareness is already fairly high, whether it’s revumenib or menin inhibitor.
I think downstream, in the community, it’s going to take a little bit of time. Part of it is just they may not see a lot of patients initially. So it’s up to us to be there. So from a commercialization standpoint, we’ll have a adequately sized team that’s going to cover 95%-plus of the opportunity. I will have a nonpersonal promotional program that will reach folks in places that we may not be at as frequently. So I think you’ll see quick uptake across the board. And a lot of it’s just patients in the office ready to be treated. Leads to your second question, and there’s not going to be much of a bolus. We have an EAP that’s in place. I can’t give the number, but it’s a certain number of patients. No one’s withholding treatment for eligible patients, to your point.
The criticality is just too high. So it will be a little, I will say, actually initially coming EAP, that will burn out over the beginning months of the launch. And then after that, we’ll expect the typical uptick just based on our assumptions and available patients.
Jason Zemansky: Got it. Makes sense. And then maybe just a quick follow up on your Phase 1 and metastatic colorectal cancer. In terms of the go, no-go decision, I know you mentioned disease stabilization as important, but was curious, is there a specific signal, I don’t know, maybe a biomarker what you’re looking for in terms of menin’s potential or hypothetical role in driving solid tumors that would just make you feel confident about investing significantly in this potential expansion opportunity?
Michael Metzger: Jason, thanks for the follow-up on CRC. I’m going to turn it over to Neil to address.
Neil Gallagher: Yeah, thanks. And so in the part of the study that has been conducted to date, I just — to reiterate Michael’s point, this is primarily the safety part of the study. We are looking at in addition to clinical responses, I mean, primarily, it’s a safety study. We’re also looking at clinical responses. We’re also looking at biomarker data. And anticipation is that as we get to a point in the future where we could make a decision on future development in this space, but this to be taken into consideration. We haven’t specifically set colorectal data we’re looking at, but at some point in the future, we will provide more details around it. I wouldn’t expect necessarily too much data in in our update in the second quarter, for instance, colorectal data. But rest assured that we are pursuing colorectal studies. And as I said, we’ll take the totality of the evidence into consideration.
Operator: Our next question is from Justin Zelin with BTIG.
Justin Zelin: Thanks for taking the question and welcome to Steve. So ahead of two launches this year, I wanted to ask how large of a sales force you’re looking to build here. And could you talk to the overlap of providers who treat both leukemia and chronic graft versus host disease from promotion of both products?
Michael Metzger: Sure. Maybe I’ll let Steve take that question.
Steve Closter: Yeah, I appreciate the question, Justin. In terms of salesforce size, we’re not prepared to provide the exact color and size of the team. But it will be a team that I think can really address customer needs. Our goal, whether it’s providers or anybody within the health care delivery system that it’s a great customer experience. So we’re prepared to link up to all different aspects of health care organizations to make sure we’re meeting the needs and supporting providers in their treatment of patients. So I think I use the term plus 95% coverage. So we’ll cover the opportunity. There is no doubt about that. In terms of overlap between on GVHD and rev, there’s high overlap. I mean, we’re likely along with Incyte calling on the same treatment centers, right, whether it’s treatment of AML or treatment of transplant, and we’ll leverage that call point.
Yeah, there’s probably a third overlap right now of our rev audience with the axa audience. We’ll obviously provide 30% of the effort. So we’ll leverage our footprint and we will cover the market opportunity in really both opportunities.
Operator: Our next question is from Chris Shibutani with Goldman Sachs.
