Curis, Inc. (CRIS) Q3 2025 Earnings Report, Transcript and Summary

Good afternoon, ladies and gentlemen, and welcome to the Curis Third Quarter 2025 Business Update Conference Call. [Operator Instructions] This call is being recorded on Thursday, November 6, 2025. I would now like to turn the conference over to Diantha Duvall, Chief Financial Officer. Please go ahead.

Thank you, and welcome to the Curis Third Quarter 2025 Business Update Call. Before we begin, I would like to encourage everyone to go to the Investors section of our website at www.curis.com to find our third quarter 2025 business update press release and related financial tables. I'd also like to remind everyone that during the call, we will be making forward-looking statements, which are based on current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. For additional details, please see our SEC filings. Joining me on today's call are Jim Dentzer, President and Chief Executive Officer; Dr. Jonathan Zung, Chief Development Officer; and Dr. Ahmed Hamdy, Chief Medical Officer. We will also be available for a question-and-answer period at the end of the call. I'd like to now turn the call over to Jim.

Thank you, Diantha. Good afternoon, everyone, and welcome to Curis' third quarter business update call. We continue to make steady progress in our TakeAim Lymphoma study, which is evaluating emavusertib in combination with ibrutinib in patients with primary CNS lymphoma, one of the most rare and most difficult to treat of the NHL subtypes. As a reminder, the TakeAim Lymphoma study is a single-arm study with an ORR endpoint that adds emavusertib to a patient's BTKi regimen after they have progressed on BTKi monotherapy. And after collaborative discussions with the FDA and EMA, we expect the study to support accelerated submissions in both the U.S. and Europe. Over the next 12 to 18 months, we'll be focused on enrolling the additional patients we'll need to support those submissions. If you recall, last quarter, we engaged with a number of KOLs who are excited and highly supportive of expanding our emavusertib studies into additional NHL subtypes. They were especially interested in exploring emavusertib's potential to fundamentally change the treatment paradigm for CLL patients where the current standard of care is BTKi monotherapy. BTK inhibitors have become the standard of care in CLL and NHL because of their ability to help patients achieve objective responses. However, these responses are typically partial responses, not complete remission. The unsurprising result is that patients who are treated with a BTK inhibitor end up having to stay on it in chronic treatment for the rest of their lives. Additionally, since patients never achieve complete remission, many of these patients develop BTKi resistant mutations and ultimately, their disease progresses. At Curis, we're looking to improve upon the current standard of care by adding emavusertib to a patient's BTKi regimen, enabling patients to achieve deeper responses and potentially come off treatment, reducing the risk of developing BTKi resistant mutations and improving a patient's overall quality of life. The first step in testing this hypothesis in CLL is to initiate a proof-of-concept study in patients currently on BTKi monotherapy who have achieved a PR, but have been unable to achieve complete remission or UMRD. We have submitted the study protocol to the FDA. We're working to activate clinical sites, and we expect to enroll our first patient in late Q4 or early Q1 with initial data expected at the ASH Annual Meeting in December 2026. Now let's turn to AML. Abstracts for the December ASH meeting were released on Tuesday, including the abstract for our ongoing AML triplet study, which is evaluating the triple combination of emavusertib with azacitidine and venetoclax in AML patients who have achieved complete remission on aza-ven but remain MRD positive. The data in the abstract are for the first 2 cohorts, patients who received emavusertib for 7 or 14 days in a 28-day cycle in addition to their aza-ven treatment. As of July 2, 2025, 10 patients with a median age of 71 were enrolled, 4 in the 7-day cohort and 6 in the 14-day cohort. MRD conversion to undetectable levels occurred in 4 of 8 evaluable patients within 5 to 8 weeks of adding emavusertib. Among the patients who remained MRD positive, 1 patient achieved a 40% MRD reduction and none showed disease progression. Two dose-limiting toxicities, CPK increase and neutropenia occurred in the 14-day cohort, but both resolved. We're very encouraged by the initial readout from these first 2 cohorts and the exciting potential of combining emavusertib with aza-ven in frontline AML to enable more patients to achieve undetectable MRD. We continue to explore different dosing regimens for this triplet combination, and we look forward to reporting our progress. As you can see, we've had a very exciting and productive quarter and have a lot of exciting updates coming at the SNO and ASH conferences over the next few weeks. With that, I'll turn the call back over to Diantha for the financial update. Diantha?

Thank you, Jim. Curis reported a net loss of $7.7 million or $0.49 per share for the third quarter of 2025 as compared to a net loss of $10.1 million or $1.70 per share for the same period in 2024. Curis reported a net loss of $26.9 million or $2.19 per share for the 9 months ended September 30, 2025, as compared to a net loss of $33.8 million or $5.77 per share for the same period in 2024. Research and development expenses were $6.4 million for the third quarter of 2025 as compared to $9.7 million for the same period in 2024. The decrease was primarily attributable to lower employee-related clinical consulting, research, manufacturing and facility costs. Research and development expenses were $22.4 million for the 9 months ended September 30, 2025, as compared to $29.6 million for the same period in 2024. General and administrative expenses were $3.7 million for the third quarter of 2025 as compared to $3.8 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs. General and administrative expenses were $11.2 million for the 9 months ended September 30, 2025, as compared to $13.4 million for the same period in 2024. Curis' cash and cash equivalents were $9.1 million as of the end -- as of September 30, 2025, and the company had approximately 12.7 million shares of common stock outstanding. Based on our current operating plan, we believe that our existing cash and cash equivalents should enable us to fund our existing operations into 2026. With that, I'd like to open the call for questions. Operator?

[Operator Instructions] Your first question comes from Sara Nik with H.C. Wainwright.

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.

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?

Sure. Sara, it's Ahmed. So basically, we're trying to address the unmet medical need in the CLL community, which is basically getting patients to a time-limited treatment with the combination of emavusertib plus a BTK inhibitor in patients who are currently on a BTK and have only achieved a PR with MRD positive. So -- and we're aligned with the FDA there, and we intend to have a small dose escalation at 100 milligram and expanding into our 200-milligram Phase II dose.

Your next question comes from Li Watsek with Cantor.

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?

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?

I think you said it all, Jim. The whole concept here that you don't see CRs in -- with BTK. And obviously, you don't see MRD negative. So getting patients to a CR, and I think anything north of 20% would be very exciting. But obviously, we're going to have to wait until we see a treatment effect in our trial and plan accordingly. But we are very hopeful that the dual blockade of inhibiting the TLR pathway along with the BCR pathway would have a much more profound effect on the NF-kappaB and therefore, getting patients to a deeper response in MRD negative.

Yes. Thank you. And Diantha, would you mind spending a moment talking about the resources?

Absolutely. So Li, as you can appreciate, our current priorities are clearly to continue the PCNSL trial and obviously launch the newly initiated CLL trial. And also, as you can appreciate, we'll be looking to bring in additional capital prior to the end of the year. We've been pretty clear about that over the last 6 months. So neither of those things should be a surprise. So that's sort of where we're thinking about our resource allocations.

Yes. And in overall messaging, Li, we continue to move forward with great progress in PCNSL. And I think the investor interest, not just in PCNSL with the [indiscernible] approval, but the ability to move the needle in CLL. It seems to be a very reachable goal and because of the market opportunity, a very exciting goal. So look forward to hearing from us more about that over the next 8 weeks.

Your next question comes from Yale Jen with Laidlaw & Company.

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.

Okay. Again, let me start, and I'll ask Dr. Hamdy to add to it. So I think the critical issue for us is going to be, do we see any DDI with the BTK inhibitors. And as you know, we have a great deal of confidence given that we've already tested a number of patients in NHL with ibrutinib, and we aren't seeing DDI. In fact, at the doses that we're testing 100 and 200 milligrams with [indiscernible], it seems to be a very clean profile. Ahmed, would you like to add to that?

Yes. I mean, again, you said it all, Jim. But yes, I mean, we have approximately 25 patients, if not more, combined with ibrutinib. And as you know, ibrutinib is probably would be the most unselective of all approved BTKs, and we have not seen any additive toxicities and we expect not to see any additive toxicity with the other BTK inhibitors. Of course, we're going to be doing some PK work in GDI following any potential toxicities, but I don't think there's any additive toxicities that we expect.

Okay. Great. That's very helpful. 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?

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.

There are no further questions at this time. I will now turn the call over to Jim Dentzer for closing remarks.

Thank you, operator, and thank you, everyone, for joining today's call. And as always, thank you to the patients and the families participating in our clinical trials, to our team at Curis for their hard work and commitment and to our partners at Aurigene, the NCI and the academic community for their ongoing collaboration and support. We look forward to updating you again soon. Operator?

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.