David Urso: Well, that was a requirement or a gate that we reached in collaboration with the clinicians. But we really need to dig into exactly what the patient population is before we can really know what the meaning of that threshold is. It obviously depends on exactly the experience that each patient [Technical Difficulty]
Yale Jen: And maybe again, one more question here, which is that if compared to what your prior study in the breast cancer or non-small cell lung, was there any comparable number to that PFS?
Richard Ghalie: Yeah, this is Richard answering. So it’s really two very different approaches to therapy here. In the Phase 1 study in combination with chemotherapy, we were really looking at cytotoxic effect and looking at response as the primary endpoint. Here, we’re really looking at a different approach where there is synthetic lethality by combining VEGF inhibitor with a mitochondrial inhibitor. And therefore the response rate is less relevant. More relevant would be the time to progression. Again, it’s a very different disease, so it would be hard to compare breast cancer, I’m sorry, colorectal cancer on one hand with a prior study which was done in ovarian cancer and small cell lung cancer.
Yale Jen: That’s great. That’s very helpful and thanks a lot. I appreciate it.
Operator: Mr. Willey, your line is open on our end. Perhaps you have it muted on yours.
Stephen Willey: No, thanks for taking the questions. Maybe just one on voruciclib, one on 344, and then just a modeling or financial question. So on voruciclib, what’s your expectations just around venetoclax retreatment post progression in the context of AML? And I guess I asked the question because there’s not a lot of data that’s out there in the public domain and there’s some re-treatment experience in CLL that’s shown that you can re-sensitize patients to venetoclax with venetoclax alone. And I’m just kind of curious as you think about the data you’re going to be generating, what’s good, what’s interesting, what is your working assumption around venetoclax retrieve and response rates?
David Urso: Yeah, I mean, the initial experience with venetoclax in the relapse refractory AML population was pretty limited. I think it was like 19 patients and they saw about a 20% response. But that was in a, as you know, that was in a venetoclax naive population. Now everybody’s getting venetoclax. But I think when we talk to our advisors, it’s still around the same threshold as what they would be excited by. I think it’s a big deal if you can bring back response to a patient that progressed on venetoclax. And 20% to 30% response rate in that — in this relapse population, I think would get everybody excited.
Stephen Willey: Okay. And then on 344, I think per clintrials.gov, it doesn’t list any of the approved salvage regimens as allowable prior therapy. So are we to assume that these patients are going to be Lonsurf and regorafenib naive?
Richard Ghalie: This is Richard. So you’re right, this is not listed on clinicaltrial, but the protocol is really abiding with what the FDA wanted. So patients should have received and progressed on or did not tolerate standard chemotherapy, which is platinum based, [energy-based] (ph), 5-FU. In addition, if they have a mutation that is addressable, like BRAF, they have to receive it. If they are eligible for checkpoint inhibition, they should have received it [indiscernible]. And only then they could enroll in the study. So we may have patients who have received regorafenib and/or long serve or not. So it’s not a requirement, but we anticipate that some patient, any in fact, would have received an end of study.
Stephen Willey: Okay, and then maybe just to follow up on the 20% four-month PFS rate that’s required to gate the enrollment of Stage 2. I guess when you look at, I think it was what the SUNLIGHT study that was just published. I think they saw a six-month PFS with Avastin and Lonsurf of north of 40%. And then I think with Lonsurf alone close to 20%. So I’m just trying to, I guess, maybe think about the threshold that you’re establishing here in the context of some of the historical data that’s out there.
