CURIS INC Q3 FY2025 earnings call

TakeAim Lymphoma Study

• Evaluating emavusertib in combination with ibrutinib in primary CNS lymphoma patients. Expect accelerated submissions in US and Europe after 12-18 months of enrolling additional patients.

CLL Program

• Initiated proof-of-concept study in CLL patients on BTKi monotherapy who achieved PR but not complete remission. Submitted study protocol to FDA, expect first patient enrollment in late Q4 or early Q1 2026, with initial data at ASH 2026.

AML Triplet Study

• Abstract for ongoing AML triplet study (emavusertib + azacitidine + venetoclax) released. Data shows MRD conversion in 4 of 8 evaluable patients, with two dose-limiting toxicities resolved. Encouraged by initial readout and potential to enable more patients to achieve undetectable MRD.

Curis reported a net loss of $7.7 million or $0.49 per share for the third quarter of 2025 compared to a net loss of $10.1 million or $1.70 per share for the same period in 2024. For the 9 months ended September 30, 2025, the net loss was $26.9 million or $2.19 per share versus $33.8 million or $5.77 per share in 2024. Research and development expenses for the third quarter of 2025 were $6.4 million compared to $9.7 million in 2024, and for the 9 months ended September 30, 2025, were $22.4 million versus $29.6 million in 2024. General and administrative expenses for the third quarter of 2025 were $3.7 million compared to $3.8 million in 2024, and for the 9 months ended September 30, 2025, were $11.2 million versus $13.4 million in 2024. Cash and cash equivalents as of September 30, 2025, were $9.1 million, with approximately 12.7 million shares of common stock outstanding. Existing cash and cash equivalents are expected to fund operations into 2026.

Forward-Looking Guidance

• Based on current operating plan, existing cash and cash equivalents should enable funding of operations into 2026.

Q: Congrats on the ongoing progress. My question was regarding your CLL program. And if you -- any color you could provide on the FDA discussions and protocol you submitted. Were you mostly aligned with primary endpoints and study design? Any granularity you can provide as of now would be helpful.

A: Thank you, Sara. Thanks for the question. I'll start, and I'll ask Dr. Hamdy to chime in as well. So we're very excited about that study. So as you know, we did have a dose escalation study where we tested across different subtypes in NHL. Our first expansion was in PCNSL and the second one is going into CLL. Obviously, as we move into CLL, it's a much larger indication. And of course, there's a much wider circle of interest among the KOLs. Ahmed, do you want to talk a little bit more about the CLL study in particular?

Q: And I guess just for the Phase II CLL trial, can you maybe just talk a little bit about the size of the study and in terms of the delta you want to achieve in terms of the CR rate? And then second is just how you're thinking about resource prioritization at this point, especially as you think about the resources that you might need to move forward with the CLL study versus the frontline AML study?

A: Sure. So again, why don't I start on CLL, I'll ask Dr. Hamdy to talk a little more detail and then maybe have Diantha talk a little bit about resources. So first, on CLL, we are anticipating a study design at this point in time that anticipates 40 patients. But of course, as we saw in PCNSL, the unmet need is so clear, we're hoping to be able to see a signal long before we get to that point. As a reminder, patients on BTKi monotherapy in CLL, they get PRs. They don't get CRs. They certainly aren't getting MRD either. So what we're looking to do in that population is demonstrate simply that by adding emavusertib, by blocking both pathways, not just one, but both pathways that are driving disease that we can end up seeing deeper responses. So that's deeper PRs, and we hope also that we'll see CRs and MRD. Ahmed, do you want to chime in a little bit more on that?

Q: I've got 2 here. First of all, in terms of the CLL study, what would you think about the safety side? In other words, in the combination, was there any sort of speculated AE may happen? And how would you think about the mitigation for that? And then I have a follow-up.

A: Thank you, Sara. Thanks for the question. I'll start, and I'll ask Dr. Hamdy to chime in as well. So we're very excited about that study. So as you know, we did have a dose escalation study where we tested across different subtypes in NHL. Our first expansion was in PCNSL and the second one is going into CLL. Obviously, as we move into CLL, it's a much larger indication. And of course, there's a much wider circle of interest among the KOLs. Ahmed, do you want to talk a little bit more about the CLL study in particular?

Q: And maybe just one more question here. In terms of the SNO meeting in a few days, what should be the investor sort of expectation to talk about?

A: Yes. So obviously, we're going to have to be a little careful not to front run the conference. But thank you, Yale, for your interest in that. Yes, we're going to have several posters, 3 of them available at the SNO conference in PCNSL, but also SCNSL. Dr. Grommes and Dr. Nayak, in particular, will be talking about PCNSL. So I think what you can expect to see there is learn a little bit more about what we've seen over the last 6 months in that study. And of course, the secondary CNS lymphoma even harder to treat, that will be brand new. So I think on both fronts, it should be a really exciting conference for us. Thank you.