Jeff Jones: Good afternoon guys and thanks for taking the question. Two questions. What do you need to see in the 6a arm to have comfort to move ahead into the proof-of-concept cohort? And over how many cycles do you need to see that? And then on the financial side, how much cash is needed to complete the three ongoing clinical studies? And how much additional are you thinking you need to do the proof-of-concept study for fadra? Thank you.
Spiro Rombotis: I think your first question Jeff is for Mark. Yes, please.
Mark Kirschbaum: Yes. I can take that quickly. That’s a happy question. So, we €“ I mean the good news is that we already know from the PD that we have on the patients in that sample that we are hitting the targets that we want to hit. So, that looks good. 6a looks good to us. What we have to do now is just confirm tolerability. So, we need to complete this first dose level, and that will happen very soon. If that goes through, then we will go to six patients, and call it an acceptable dose. So, that’s coming up soon. And let me turn it back to Spiro for the other questions.
Spiro Rombotis: Actually Paul’s questions.
Paul McBarron: Yes. So, let me €“ we will take that question. Thank you very much. So, as we have mentioned, we have cash that runs through to the end of this year, Q4 2023. The way that we have budgeted that is to clearly run Phase 2 €“ into the Phase 2 for fadra, the oral fadra in solid tumors and lymphoma as once we get through RP2D, start the Phase 2, we are budgeted to get into PoC. And we believe with our milestones that we will be able to report out of that PoC in this current year within the current cash envelope. The other two studies we are currently assuming we will get to dose escalation again within 2023.
Jeff Jones: Thank you.
Operator: We will move next to Birc Dolliver of Brookline Capital Markets.
Kemp Dolliver: Hi. This is Kemp Dolliver. Quickly, on the timing of readouts and the cadence, what’s your sense as to how they will play out during the year?
Spiro Rombotis: Hello Kemp, thanks for your question. We think that, obviously, declaration of RP2D for fadra, the 101 study in solid tumors and lymphoma is probably the most important milestone for the first half of the year. The company plans to make an announcement once we reach that critical milestone. And as you already are aware, the protocol is seamless. It moves straight into Phase 2. So, we expect the next batch of milestones for that study will come from initial cohorts that will enroll fastest. We mentioned in the previous question that we think that’s likely to be lymphoma and women’s cancers. And so this futility study is based on X responses over Y and release in that cohort we expect to report that fairly early as other cohorts may take longer to enroll.
When it comes to the leukemia study, I think that one has picked up enrollment pace. We are able to also get FDA agreements to jump at dose level or two based on safety in the solid tumor study. That’s €“ as Paul just mentioned, we will probably get to the €“ through the dose escalation stage to the proximity of RP2D. But there may be some crosstalk between the leukemia study and the solid tumor study. That often happens. And of course, we will always be looking to finish the Plogosertib Phase 1 dose escalation component and hopefully get as close to RP2D as we can with the important qualification. But in that program, the low dose may be sufficient to achieve target engagement in PD levels. So, that remains to be determined, of course, but that is a potential readout as well within 2023.
