James Breitmeyer: And I’ll add one comment to Salim to that is, we have taken the FDA’s recommendations in Project Optimus to heart and study them very carefully. And we’re well aware that FDA is hoping to have new product development occur in a way that is more thoughtful about arriving at a Phase 2 and ultimately Phase 3 dose. So I would expect that and they’ve offered to be more communicative with early data here. And so we are building in the Project Optimus kind of thinking into both of our early stage programs, both 808 and 534.
Operator: And our next question comes from the line of Li Watsek with Cantor Fitzgerald. Please proceed with your question.
Unidentified Analyst: Hi, this is Rosemary on for Li. Thank you so much for taking our questions. Just two for me, so firstly with ZILO and CLL with the TP53 mutations, how are you thinking about the next for this program? And then second for 534, could you talk a little bit about your potential Phase 1 trial design and how quickly you might be able to generate initial data? Thank you.
James Breitmeyer: Thanks, Rosemary. Your first question broke up a little bit. Could you repeat it?
Unidentified Analyst: Sorry, so for ZILO and CLL with TP53 mutations, how are you thinking about next steps for this program?
James Breitmeyer: Go ahead, Salim.
Salim Yazji: Yes, so we are evaluating all the aspects of the potential unmet medical need for patients with TP53 deletion 17p and CLL specifically. And as you may know, as patients goes into multiple line of therapy, I think they get to have much higher percentage of that mutation and it’s become very hard to treat and the prognostic factor for those patients is not optimal. So if we would like to do this, we would like to do this in combination with either one of the second generation BTKi’s or was a physician choice of a BTKi versus physician choice of the monotherapy in the second arm.
James Breitmeyer: And the 534 trial design.
Salim Yazji: Yes, and the 534 trial design, we’re using basic design which will get us actually to dose escalate faster if there’s no safety concern. So we’re hoping that that would get us into the therapeutic dose as soon as possible. And as Jim said, we are actually expanding into cohort to be in line with the Project Optimus that the FDA is promoting now to look into a recommended Phase 2 dose or actually two doses and then choosing one of them to go into the Phase 3.
Unidentified Analyst: Thank you.
Salim Yazji: You’re welcome.
Operator: There are no further questions at this time and I would like to turn the floor back over to James Breitmeyer for any closing comments.
James Breitmeyer: Thank you very much for joining us today for Oncternal’s earnings call. Enjoy your evening and we look forward to staying in touch with you. Good night.
Operator: This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation and have a great day.
