I will now turn the call back over to Chip.
John Scarlett: Thanks very much, Michelle. With our strong IMerge Phase 3 data and with our regulatory submissions based on these data currently under review by both the FDA and EMA, we believe there’s a robust market opportunity in front of us in transfusion dependent lower risk MDS. In addition, we remain excited by our second Phase 3 readout and JAK I relapsed and refractory MF for which we expect an interim analysis in the first half of 2025 and the final analysis in the first half of 2026. These programs represent important opportunities for the patients we serve and for our shareholders whose interests we represent. We look forward to keeping you updated on our progress and will now open the line to questions. Operator?
Operator: [Operator Instructions] We will go first to Stephen Willey at Stifel.
Tuuli Tsogtbaatar: Yes, this is Tuuli on for Steve. Thank you for taking my questions. We have three questions on our end. Firstly, can you guys give us an additional color on the dose level; one, basically what those dose levels was in ImproveMF study and maybe more color on the dose escalation scheme whether this dosing was higher or about the same dose level as low risk MDS dose. And whether maybe like dosing schedules. That would be helpful. And second, can you guys talk a little bit about whether FDA is granting of broad label to luspatercept in the first line patients impact your perception of risk benefit of imetelstat. And lastly, are you guys planning on actually disclosing or announcing when the enrollment hits 50% target in IMpactMF study? That would be it. Thank you.
John Scarlett: Great. Thank you very much. I’m going to invite Faye to make any comments that she can about the ImproveMF dosing, and how that might relate to some of our other dosing in, for example, low risk MDS or MF, a single agent use. Faye?
Faye Feller: Thanks, Chip. The dosing for the ImproveMF study is mostly based on — this is a safety study. So it starts at a lower dose, and then dose escalates to our highest dose that we used in MF. The dosing scheme is publicly available on pt.gov. And I think within the corporate deck, Appendix, that first dose level was 4.7 milligrams per kilogram of imetelstat and the next is six milligrams per kilogram. Importantly, again, this study is really to assess the safety of the combination therapy in a frontline MF setting.
John Scarlett: Second question, related, is that did you have any follow up questions or shall we move on to the FDA or sorry, the broad label commentary. Okay, let’s move on. So the second question, I’m going to invite Anil to address I believe the question was, did the assignment of a broad label to the luspatercept frontline use? Does that read in any way on from our perception on the risk benefit from imetelstat? I believe I got that right. Anil?
Anil Kapur: Thank you for the question. The frontline indication in the frontline population is very different from the population that’s been studied. For imetelstat and IMerge, our focus was ESA relapsed refractory patients who are transfusion dependent. And so that’s a very different population from the frontline commands, which looked at the front — ESA naive patient population that got treated. So as a non-clinician, my feeling would be that it does not have a risk benefit impact to our trial, but I would invite Faye to provide her clinical judgment as well.
Faye Feller: Agree, Anil. The patient population studied in the command has minimal as any overlap with any patient population within IMerge. So impact on risk benefit is negligible or non-existent in my opinion.
John Scarlett: And then the third question was, do we plan on disclosing when 50% enrollment is hit in IMpactMF? The answer is, yes, we do. That’s historically been our practice with all of the clinical studies we’ve run for the last many years. I’m not sure exactly the form that will take kind of depends on timing around other activities, et cetera. But we do plan to make that publicly available. Okay, maybe we could go to the next question.
Operator: We’ll move next to Corinne Jenkins at Goldman Sachs.
Craig Miller: Good morning. This is Craig on for Corinne. So one question from us. You previously announced the initiation of your EAP. And I guess now having some time under your belt? Can you give us some color on the types of patients that have enrolled in that and maybe some of the feedback that you’ve received so far, on the use of imetelstat through it?
John Scarlett: That’s a great question. I think the question was what kind of feedback or what are we seeing with the types of patients who are being proposed for the EAP? Maybe Faye, you could talk a little bit about that.
Faye Feller: Sure. Thanks for this question. Just a reminder that the EAP is similar to a clinical trial in that enrollment criteria and site initiation criteria is similar to that we use on the IMerge Phase 3 study. However, it’s different from a clinical trial and that we cannot recruit for it. It is based on investigator request. So as the trial is still in progress and ongoing, we’re really assessing enrollment and the types of patients and we’re not providing further details at this time.
Craig Miller: Got it. That’s helpful. And one more from us. So, how are you guys all preparing for the advisory committee meeting with the FDA? And what sorts of topics do you anticipate will be in focus at the event? Thank you.
John Scarlett: I’ll let Faye take that and I will supplement as needed. But Faye, why don’t you take first crack at that.
