Curis Inc (CRIS) 2025 Q3 法說會逐字稿

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 investor 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 James Dentzer, President and Chief Executive Officer, Doctor Jonathan Zung, Chief Development Officer. And Doctor 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's third quarter business update call.

We continue to make steady progress in our take aim lymphoma study, which is evaluating emusertib 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 take a 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 US 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 were excited and highly supportive of expanding our emavusertib studies into additional NHL subtypes.

They were especially interested in exploring Emma Vertib'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 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 azacytidine and venetolox in AML patients who have achieved complete remission on Azov but remain MRD positive.

The data in the abstract are for the first two cohorts, patients who received emavusertib for 7 or 14 days in a 28 day cycle, in addition to their Azoven 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 valuable patients within 5 to 8 weeks of adding emmertin.

Among the patients who remained MRD positive. One 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 two cohorts and the exciting potential of combining emavusertib with Aza 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 snow 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.

Cure supported 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.

Your reported a net loss of $26.9 million or $2.19 per share for the nine 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 nine months ended September 30th, 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 administrative expenses were $11.2 million for the nine months ended September 30, 2025, as compared to $13.4 million for the same period in 2024.

Turris's cash and cash equivalents were $9.1 million as of the end of September 30th, 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.

Thank you ladies and gentlemen. We will now begin the question-and-answer session. (Operator Instructions)

Your first question comes from Sara Nik with HC Wainwright. Your line is now open.

Hi, team, and thanks for taking the question. 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.

Thank you, sir, and thanks for the question. I'll start and I'll ask, Doctor Hamdi to chime in as well. So, we're very excited about that study. So as we did have a dose escalation study where we tested across different subtypes in NHL. Our first expansion was in the 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, hi, 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 a combination of M Vucerta 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 mg and expanding into our 200 mg, phase two dose.

Great, thank you.

Your next question comes from Li Watsek with Cantor. Your line is now open.

Hey.

Guys, thanks for taking our questions.

And I guess just for the phase to CR 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, the sales study versus the phone ML study.

Sure. So, again, why don't I start on CLL? I'll ask Doctor 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 designed at this point in time that anticipates 40 patients, but, of course, as we saw in PC andSL, 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 am of assertive, 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?

Well, 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 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 kappa B and therefore getting patients to a deeper, response in MRD negative.

Yeah, 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 the investor interest not just in PCNSL with the eye to 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.

Ladies and gentlemen, as a reminder, should you have a question, please press one. Your next question comes from Yale Jen with Laidlaw and Company. Your line is now open.

Good afternoon and thanks for taking the questions. I got two here. First of all, in terms of the CLL study, what were you thinking about the safety side? In other words, in a combination, was there any sort of speculated, AE, may happen and, how would you think about the mitigation for that, and then have a follow-up.

Okay. Again, let me start and I'll ask, Doctor Hamdy to add to it. So the critical issue for us, is going to be, do we see any DDI with the BTK inhibitors. And as 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 mg with them, it seems to be a very clean profile. Ahmed, would you like to add to that?

We have approximately 25 patients, if not more combined with ibrutinib, and as 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 and DDI 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 snow meeting in a few days, what should be the investor sort of expectation to talk about and, then thanks a lot.

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, we're going to have several, posters, 3 of them, available at the Snow conference in PCNSL, but also SCNSL.

Doctor Gromus, and Doctor Nyek in particular will be talking about, PCSL. So 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 on both fronts, it should be a really exciting conference for us.

Thank you.

Okay, great. Thanks a lot and congrats on all the progress.

Thank you so much.

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 Orygen, 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 line.