Karen Hunady: Thanks, Phil.
Operator: Thank you. Your next question comes from Mark Breidenbach from Oppenheimer. Please go ahead.
Mark Breidenbach: Hey. Good morning. Thanks for taking our questions. Just a couple of quick ones for me as well. First of all, can you just remind us if there any futility analyses built into the SELECT-MDS-1 protocol that we could see between now and top-line data in the third quarter of next year? And then the second question is just housekeeping for Jason. I’m wondering, if share count has stabilized now. I think it’s around 20.3 million in the 10-K. Is that number expected to fluctuate much or is it kind of settled around there following the merger with TYME? Thanks for taking the questions.
Nancy Simonian: Hey, Mark, I’ll take the first one. So on the futility, we have not guided to any expectations for futility analysis. So I think really the focus should be on the pivotal CR data in the third quarter of 2024.
Mark Breidenbach: Okay.
Jason Haas: And Mark, it’s Jason. On the share count we have 20.3 million basic shares outstanding and that ought to remains relatively stable. We also have 7.5 million prefunded warrants. So the way I would think about our share count is a total of 27.8 million shares outstanding. So to the extent some of the investors who took prefunded warrants convert those warrants into common shares we’ll just have a different distribution between the common and the prefunded, but the aggregate number of shares ought to remain relatively constant at 27.8 million in round numbers.
Mark Breidenbach: Understood. Okay. That’s super helpful. Thank you.
Karen Hunady: Thanks, Mark.
Operator: Thank you. Your next question comes from Jason Butler from JMP Securities. Please go ahead.
Jason Butler: Hi. Thanks for taking questions. Two for me also. Just on SELECT-AML, can you just remind us if you’re stratifying patients by monocytic expression score? And then for 2101 , have you already had interactions with FDA that support — the potential for an expedited path, or if not can you talk about what plans you would have to interact with FDA before we get the update later this year? Thanks.
Nancy Simonian: So I’ll have David take the first. And just to clarify the second question was related to 2101.
Jason Butler: Yes.
Nancy Simonian: David you had any? Okay. Yes.
David Roth: So with respect to the AML, you’re asking about what the AML trial is stratified by…
Nancy Simonian: Whether selecting based on — any selection based on the monocytic phenotype.
David Roth: Yes. No. So we — we’re not. The criteria are consistent with the design of the original Phase II at the newly diagnosed unfit provided they have RARA overexpression using the same test we’ve used all along. Obviously, we are going to be collecting that data and looking at that and that’s going to be very important for us to understand that correlation. We did report from the ASH presentation you may recall we had six patients who were evaluable for clinical activity. And we saw an 83% CR/CRi rate, which was really encouraging. And of five of the patients at that time who we had the monocytic expression score evaluated four were positive. So that’s again 80% positivity rate which was spot on for the prior analysis from the Phase II.
So we have reason to predict consistency of data across the trials and look forward to giving you an update later this year. And then with respect to the 2101 trial, you’re asking if we’ve had regulatory interactions that — I think it’s a little premature for us to discuss that we haven’t disclosed specifically. We do in the course of our ordinary development communicate with the regulators globally regarding our plans to make sure we’re on the right path. But I think that will be part of what we look forward to discussing in the second half of the year we give you more clarity on our next steps.
