Jim Dentzer: Yes. Thank you, Yale. Appreciate the question. So you’re exactly right, the opportunity in MDS looks terrific. The clinical data that we’ve put out so far looks as though in MDS just as it did in AML and just as it has in lymphoma, it appears as though this drug has a single agent is active. It provides unique and compelling anticancer activity. We would really like to do in MDS what we’re doing in leukemia, which is go frontline in combination with standard of care and see whether or not we can provide benefit. Can this really add to the effectiveness of standard of care? Well in AML we know what the standard of care is. It’s aza-ven. I think MDS development has just gone a little slower with aza-ven. A lot of people were expecting it might have read out this past to ASH.
Now people are looking for ASCO to be frank. We don’t know any more than you do of when those are going to read out, but we do expect it’s imminent. And the answer is standard of care in MDS is going to be either aza or the aza-ven doublet. If VERONA reads out positively it’s aza-ven; if it reads out negatively its aza. And what we want to know is which of those two wins, if you like, so that we can then initiate a combo, whether it’s a doublet or a triplet to see whether we can add benefit to that population in the frontline setting. So we’re eagerly anticipating it as you are. And as soon as we have those results, we’ll be looking to initiate a frontline study in combination in MDS as well.
Q – Yale Jen: Okay. Great. That’s very helpful. And my second question here is that earlier we thought — we were sort of expecting that you guys may conduct a meeting with the FDA to talk about the next stage of development after the AML data. Do you anticipate this meeting could happen later — much later this year or you anticipate this potentially be a 2025 event?
Jim Dentzer: So I really can’t speak on behalf of the FDA, how quickly we’re going to have that meeting. We are, of course, very interested in having it as soon as possible. I think we have the kind of drug that the FDA should likely be as interested in as all of our investigators are. And that is, we’ve got a drug that has a great safety profile, that really seems to add efficacy wherever we’re testing it and may be able to provide benefit in areas like second-line PCNSL where there are no drugs approved. The FDA ought to be receptive to that. So as soon as we can get a sufficient number of patients together, and it’s probably in that 10 to 20 range, depending upon what kind of results we’re getting, if the results are consistent moving forward to what we’ve seen in the past, we’d be looking to have a meeting with FDA as soon as we can.
And then, of course, as you know, the FDA has got a lot of guidelines about when you apply and how quickly they have those meetings. But we’d be somewhat subject to the FDA’s scheduling on their end. But we look really forward to being able to tell you when we’ve got that call on the docket, so that we can push forward these drugs as quickly as possible.
Q – Yale Jen: Okay. Great. Maybe just tackle one last housekeeping question. I know you guys do not typically give guidance in terms of the operating expenses. But could you give more directionally — directional sort of suggestion in terms of the operating expenses this year 2024 comparing to 2023. Thanks.
Jim Dentzer: Yes. Why don’t I ask Diantha to chime in on that.
Diantha Duvall: Thanks, Jim. So yes, I mean, we believe that our operating expenses are going to remain relatively consistent. As we’ve guided, the $56 million of cash gets us into 2025. So that gives us a burn rate in kind of 10% to 12%, may peak up to 13% depending on timing of some manufacturing and other things that tend to be a little bit more chunky. But I think you should expect it to be fairly consistent year-over-year.
Q – Yale Jen: Okay. Great. Thanks a lot. Congrats all of the development and look forward to the data readout
Jim Dentzer:
, :
Operator: The next question comes from Bill Jahangiri [ph] of Truist Securities. Please go ahead.
Q – Unidentified Analyst: Congratulations. Thanks for taking the questions. We were wondering if there were any — if you could tell us anything about strategic or partnership interest at JPM from your end. And then also for the triplet study in AML for the patients you’re enrolling, could you just remind us what the bars would be for that one? Thank you.
Jim Dentzer: Sure. Thanks Bill. So as you can imagine the interest that we’ve seen on the partnering side kind of mirrors the interest that we’ve got in the investigator side participating in our trials. And we of course, are always having conversations, with potential partners. And at some point, I think many people would like to imagine that if we can go broadly, with this drug everywhere where we think it could work. So that’s across lymphoma in areas wherever BTK gets used in leukemia, AML and MDS in a frontline setting and now in solid tumors. We just started in melanoma. But as I mentioned, there are a number of other solid tumor indications that have been studied with our drug by NCI and academic centers. And Curis just can’t afford — we’re too small, we can’t afford to run studies in all those areas.
At some point, it’s going to make sense to turbocharge those clinical efforts with the help of a partner both with bank book and manpower. Going forward, I think it’s unlikely that we’re going to strike a deal as we did in melanoma where we don’t have to give up any rights, and we get — just providing drug, we get data. But I think at some point that will make sense. And I would say, we’re not giving guidance on timing for that, but I’d say stay tuned. This looks to be a really compelling drug, and Curis is not the only company that’s recognized that. And could you remind me, Bill, the second part of your question?
Unidentified Analyst: Yes, for the triplet. So I’m not really sure what the patients look like and the eligibility criteria. So I was wondering if you could just tell us like what the bar would be for success there. And just overall benchmarks.
Jim Dentzer: Right. Thank you. Yes, I think as I mentioned to Li Watsek at Cantor, I think the bar really is — it’s a safety bar in the early days. We are cognizant that the doublet of Aza/Ven is difficult for patients to tolerate. When we look at the drugs we’re combining with, whether it’s Aza/Ven or ibrutinib for that matter, these are all drugs that they’re effective, but their safety profiles are tough. And so the first order of business, if we’re going to combine with those, we want to make sure that we don’t take a difficult regimen to tolerate and may get worse. So first things first. There’s no reason to believe we have an overlap of safety profile, but we need to test that out in patients and make sure that, that’s so.
It’s easily the thing we’re looking for first. Now of course, whenever you’re looking for safety, once you pass that hurdle, you’re going to be looking for signs of efficacy. And we’re going to want to be able to see that we can replicate in the clinic with the triplet what we’ve been able to do in all of our other studies to-date, and that is recapitulate the preclinical experience and show that adding emavusertib, that addressing this novel driver of cancer in IRAK4, that addressing that target does yield incremental efficacy above and beyond current standard of care. And if we can do that, I think that’s the home run. So first things first, safety, but of course, we’re going to look for efficacy as well. Hopefully…
Q – Unidentified Analyst: That’s wonderful.
Jim Dentzer: Yes.
Q – Unidentified Analyst: Yes. And I guess, one last one. I just want to verify, make sure I’m not thinking about this incorrectly. It seems like you’re already hitting the duration bar in CNS lymphoma, right? We just need that data set to grow?
Jim Dentzer: Yes. I think we — it’s exactly right. I think the data set was fantastic. In fact, it was quite a bit better than we would need. But it’s early days, stand up 5. So as we go to 10 and then to 20 patients, as I said, I think what we need to be able to show, if you had 20 patients with primary CNS lymphoma, that you were treating that had failed high-dose methotrexate and chemo. Today, they’re going to go on BTK. They’re going to go on ibrutinib. You’d expect four of those 20 patients to get a response based on the largest study that’s been done on ibrutinib monotherapy, CR rate of 19. So let’s round up a little bit, call it, 20 you’d need four CRs out of 20 patients. In our case, we’re three of five. We need to add 15 more patients and get one more CR just to match the earlier line.
Because remember, all of our patients have failed ibrutinib. You’d expect zero out of 20, if you rechallenge them with ibrutinib. So in our case, if we can match that prior line of get four out of 20 or one more CR out of the next 15 patients, I think we’ve got a really compelling discussion to have with FDA. And I think, frankly, our odds are pretty good at that.
Q – Unidentified Analyst: Thank you.
Jim Dentzer: You bet.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over to the company’s President and Chief Executive Officer, Jim Dentzer for any closing remarks.
Jim Dentzer: Thank you, Andrea. And thank you, everyone, for joining today’s call, and as always, thank you to the patients and families participating in our clinical trials, to our team at Curis for their hard work and commitment and to our partners at Aurigene and the NCI for their ongoing help and support. We look forward to updating you again soon. Operator?
Operator: The conference has now concluded. Thank you for attending today’s presentation and you may now disconnect.
