CURIS INC Q2 FY2024 earnings call

TakeAim Lymphoma Study

• Evaluates emavusertib + ibrutinib in relapsed/refractory PCNSL patients who failed BTK inhibitor. Presented data at ASH 2023 with over 50% objective response rate. Initiated regulatory discussions with FDA/EU for registrational path. Emavusertib granted orphan drug designation in EU. Aim to reach 30 clinical sites in US/Europe and have initial data for 15-20 patients by year-end.

TakeAim Leukemia Study

• Evaluates emavusertib monotherapy in relapsed/refractory AML. Updated data at ASCO/EHA 2024: 4/18 splicing factor mutation patients responded, 6/11 FLT3 mutation patients responded. Frontline study with emavusertib + azacitidine + venetoclax initiated, expected safety data later in 2024.

There are no traditional product segments with revenue contributions discussed; focus is on clinical studies for emavusertib in lymphoma and leukemia.

Guidance

• Aim to reach 30 clinical sites in the U.S. and Europe by year-end.
• Have initial data for 15 to 20 patients in the TakeAim Lymphoma study by year-end.
• Frontline AML study with emavusertib + azacitidine + venetoclax expects safety data later in 2024.

Risks

• Uncertainty in regulatory discussions and outcomes.
• Clinical trial results may not meet expectations.
• Competition in the oncology space poses challenges.

Q: In terms of PCNSL readout toward the end of the year, what do you consider to be the bar for advancing the program forward?

A: So just as a reminder, we’re looking to treat patients who have failed the BTK inhibitor. We’re looking to see if we can show that the thesis holds, that even if you’ve failed on a BTK inhibitor, adding emavusertib to it fundamentally changes the efficacy of that regimen.

Q: For the leukemia, you have different options to contemplate in terms of whether for FLT3, you will treat targeting either the naïve treatment -- naïve or treatment-experienced, as well as for the FFM that you would treat, obviously, only the treatment-experienced. How would you consider different optionality or maybe you want to take it all heading to 2025?

A: So, as you know, in leukemia, there’s more optionality and that’s a fortunate consequence of the design of the molecule, right? Because the molecule hits IRAK4, which is expressed in nearly every patient.

Q: Jim, you mentioned when you were discussing TakeAim Lymphoma that you recently met with the FDA to discuss those registrational paths. Just wanted to know your thoughts on what your ideal regulatory path would be?

A: Well, I think we would like to move as expeditiously as we can, of course. The typical path in drug development is to conclude your Phase I, II study and have an end-of-phase meeting, and then talk about with the FDA how do you design the pivotal study.

Q: Are you seeing any specific, when you’re approaching the physicians for the enrollment, are you seeing any specific comments, like are they reluctant or there is no other options for these patients, so it’s an easy pitch to use ema in this setting?

A: No. Unfortunately for the patients, but fortunately for the study, I think the unmet need in this population is, well, frankly, it’s horrible for those patients. There are no drugs approved. Frontline, as you know, it’s really high-dose methotrexate, chemo, and whole brain radiation. Once they progress on that, they typically go on ibrutinib, and then after that, there really is nothing. We hope to be part of a solution for these patients that in bringing this new treatment, it looks as though early days, early data, but it has the potential to be very promising.

Q: In the solid tumor, do we have any visibility if the bladder cancer trial, when it will start recruiting, I don’t know if this is an investigator-run trial with KEYTRUDA and emavusertib. Any thoughts would be appreciated.

A: Sure. So as you know, we’ve got five investigator-sponsored trials going on right now in solid tumors. We’ve been focusing on the NHL study, and of course, the leukemia study, because those are the ones that are company-sponsored and those are the ones where we’ve got clinical data.

Q: Jim, you mentioned when you were discussing the frontline AML combo strategy. Just curious if there’s a plan to maybe stratify by IRAK4 long discussion and maybe have a step plan built around that, as well as for all comers?

A: Yeah. So, I think we’re thinking in leukemia, as you note, or certainly as you’re implying, that there is a separate strategy for monotherapy versus combination. So, with FLT3 as an additional target, I think that offers the ability, given that the drug targets both IRAK4 and FLT3, offers the potential for best-in-class therapy among the FLT3 inhibitors, which is a third of the population in AML.