Curis Q4 2025 Earnings Call - PCNSL Take Aim registrational study on track for accelerated submissions

Conference Operator: Conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded today, Thursday, March nineteenth, two thousand and twenty-six. I would now like to turn the conference over to Diantha Duvall, Curis Chief Financial Officer. Please go ahead.

Diantha Duvall, Chief Financial Officer, Curis: Thank you and welcome to Curis’s fourth quarter 2025 business update call. Before we begin, I’d like to encourage everyone to go to the investors section of our website at www.curis.com to find our fourth quarter 2025 business update, press release and related financial tables. I would also like to remind everyone that during the call we will be making forward-looking statements, which are based on our 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 today on today’s call are James 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 it over to James Dentzer.

James Dentzer, President and Chief Executive Officer, Curis: Thank you, Diantha. Good afternoon, everyone, and welcome to Curis’s fourth quarter business update call. We continue to make steady progress in our Take Aim Lymphoma study in primary CNS lymphoma, one of the most rare and most difficult to treat of the NHL subtypes. As a reminder, the Take Aim Lymphoma study is a single-arm registrational study with an ORR endpoint that is evaluating emavusertib in combination with ibrutinib after a patient has progressed on BTKI therapy. After collaborative discussions with FDA and EMA, we expect the study to support accelerated submissions in both the U.S. and Europe. We continue to make good progress on enrollment in this registrational study and appreciate the ongoing support of our clinical investigators, key opinion leaders, and regulatory authorities.

As you recall, last quarter, we engaged with a number of KOLs who were excited and highly supportive about 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. Over the last decade, 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 result is that patients treated with a BTK inhibitor end up having to stay on it in chronic treatment for the rest of their lives. Additionally, because they never achieve complete remission, many of these patients develop BTKI-resistant mutations, and ultimately, their disease progresses.

We are looking to improve upon the current standard of care by adding emavusertib to a patient’s BTKI regimen, applying a dual blockade to the two biologic pathways driving CLL. This dual blockade can enable patients whose NHL subtype partially responds to a BTK inhibitor to achieve deeper responses with the combination, including the ability to achieve complete remission or undetectable disease and the potential for time-limited treatment. If we are successful, adding emavusertib to BTKI could change the treatment paradigm in CLL, reducing the risk of developing a treatment-resistant mutation and improving a patient’s overall quality of life. The first step in testing this hypothesis in CLL is our proof of concept study in patients currently on BTKI monotherapy who have achieved partial remission but have been unable to achieve complete remission or undetectable MRD.

We have begun activating clinical sites in the U.S. and Europe and expect to have initial data at the ASH annual meeting in December. With that, let’s turn to AML. At the ASH meeting in December, we presented data 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. These data were for the first 2 cohorts where patients received emavusertib for either 7 or 14 days in a 28-day cycle. In addition to their azacitidine and venetoclax treatment. In this study, 5 of 8 evaluable patients were able to achieve MRD conversion. That is, they were able to convert from MRD positive to undetectable disease.

We’re very encouraged by these initial data and the exciting potential of combining emavusertib with azacitidine and venetoclax. As you can see, we had a very productive quarter, and then we look forward, of course, to a very exciting 2026 as we’re advancing our registrational study in PCNSL and initiating our proof of concept study in CLL. With that, I’ll turn the call over to Diantha for the financial update.

Diantha Duvall, Chief Financial Officer, Curis: Thank you, Jim. Curis reported net income of $19.4 million or $1.23 per share for the fourth quarter of 2025, as compared to a net loss of $9.6 million or $1.25 per share for the same period in 2024. The net income in the fourth quarter of 2025 is due to a $27.2 million one-time non-cash gain attributable to our sale of Erivedge to Oberland. Curis reported net loss of $7.6 million or $0.58 per share for the year ended December 31, 2025, as compared to a net loss of $43.4 million or $6.88 per share for the same period in 2024.

Research and development expenses were $5.8 million for the fourth quarter of 2025, as compared to $9 million for the same period in 2024. The decrease was primarily attributable to lower manufacturing, employee-related, and clinical costs. Research and development expenses were $28.3 million for the year ended December 31, 2025, as compared to $38.6 million for the same period in 2024. General and administrative expenses were $2.9 million for the fourth quarter of 2025, as compared to $3.4 million for the same period in 2024. The decrease was primarily attributable to lower employee-related costs. General and administrative expenses were $14 million for the year ended December 31, 2025, as compared to $16.8 million for the same period in 2024.

Curis’ cash and cash equivalents as of December 31, 2025, together with initial gross proceeds of $20.2 million received in January 2026, and expected gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE financing Series B warrants upon the public announcement of dosing of the 5th CLL patient in our Take Aim CLL study expected later this year, should enable our planned operations into the second half of 2027. With that, I’d like to open up the call for questions. Operator?

Conference Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number two. If you’re using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Our first question comes from the line of Srikripa Devarakonda from Truist Securities. Your line is now open.

Srikripa Devarakonda, Analyst, Truist Securities: Hi, guys. Thanks so much for taking our question, and congrats on the progress. Just one quick question in terms of how you guys are thinking about prioritizing, kind of the trial progress between the pivotal PCNSL versus CLL and AML?

James Dentzer, President and Chief Executive Officer, Curis: Sure. Thanks for the question and thanks for calling in. As you can imagine, we’re very thoughtful about how we’re prioritizing our resources. Thankfully, the January financing puts us on a very solid course, but we’re still prioritizing our resources to be as efficient as we can in our spend. With that said, we’re definitely prioritizing NHL ahead of AML. Right now, of course, we’ve got a dual-pronged strategy where we’re pushing forward very aggressively in PCNSL. That’s you know one of the smallest and most rare of the subtypes of NHL, as well as CLL, which is inarguably the largest. PCNSL, of course, is going to be for registrational approval, and we’re moving ahead you know really right on track on that one.

With CLL, we’ve just started that study. In terms of spend, I’d say the bulk of our spend is going towards PCNSL. In these early days, CLL is, of course, much smaller, but I imagine that over time, that will get larger. My hope is that by the time we get to the end of the year, we will have made significant progress towards a registrational data set in PCNSL and hopefully have some initial data, our first view at CLL. Those two are clearly our first priorities. As we are able to raise more cash and we can get more work started, I think that’s when we start to look at AML.

Right now, I think the bulk of the work in AML is more analyzing what steps we want to take as we have more resources and what makes the most sense, and making sure that operationally our focus is on PCNSL and CLL.

Srikripa Devarakonda, Analyst, Truist Securities: Okay. Great. Thank you so much.

James Dentzer, President and Chief Executive Officer, Curis: Is that helpful?

Srikripa Devarakonda, Analyst, Truist Securities: Yep.

James Dentzer, President and Chief Executive Officer, Curis: Oh, good.

Conference Operator: Our next question comes from the line of Yale Jen from Laidlaw & Company. Your line is now open.

Yale Jen, Analyst, Laidlaw & Company: Great. Thanks a lot, and appreciate taking the questions. Just two up here. The first one is in terms of the PCNSL. You mentioned the enrollment is on track. Could you give any updates at this moment? Then I have a follow-up.

James Dentzer, President and Chief Executive Officer, Curis: Sure. We’re trying not to give enrollment on PCNSL other than we’re on track for what we’ve suggested. As we all know, it’s very hard to find these patients. You know, we get a patient or two a month, but it’s pretty choppy. You know, you might go one month where you don’t get any patients, and then the next month you get three. I’d say right now we’re enrolling patients, and on margins, I think everything is going according to plan. If we’re correct, you know, I’ve said in the past that we’re somewhere in that 12-18-month range from full enrollment. That would place us at full enrollment with the potential to, after 6 months of following patients filing, that’ll put us somewhere in the 2027 range.

We could well be in a position by the end of the year that we’re really close to that full enrollment number, and we’ve got some nice data to talk about. I don’t expect we’re gonna have a whole lot to say ahead of them. Does that make sense?

Yale Jen, Analyst, Laidlaw & Company: Okay, great.

James Dentzer, President and Chief Executive Officer, Curis: Yeah.

Yale Jen, Analyst, Laidlaw & Company: Yeah, that makes a lot of sense. Maybe just a quick question for in terms of the modeling for next years, given that you have this $27 million non-cash items as well as a reduced revenue in the fourth quarter of last year, should we model that there will be no meaningful revenue for 2026 and maybe beyond before your product approval and other stuff? Thanks.

James Dentzer, President and Chief Executive Officer, Curis: Yeah. Thank you, Yale. Actually, I’m gonna ask Diantha to chime in on that one.

Diantha Duvall, Chief Financial Officer, Curis: Sure. Yale, that’s correct. We’ll have no meaningful revenue. The revenue effectively ended in November of 2025. From a cash flow perspective, remember that we had sold the royalty, the right to about 85% of those royalties to Oberland, prior to giving them the remaining 15%. From a cash flow perspective, the remaining 15% of those cash flows are now going to Oberland. We’ll have no revenue and the remaining 15% of cash flows, but it’s not a you know meaningful impact to cash flows.

James Dentzer, President and Chief Executive Officer, Curis: Yeah. What you saw in the release is really the non-cash wind down of that arrangement. It was a very small revenue stream associated with Erivedge in the last couple of years, and we just sold what was remaining to Oberland to clean it all up. We are now completely-

Yale Jen, Analyst, Laidlaw & Company: Okay, great.

James Dentzer, President and Chief Executive Officer, Curis: independent of the Erivedge stream.

Yale Jen, Analyst, Laidlaw & Company: Okay, great. That’s very helpful, and congrats with the balance sheets and the advance of programs forward.

James Dentzer, President and Chief Executive Officer, Curis: Thank you.

Diantha Duvall, Chief Financial Officer, Curis: Thanks.

James Dentzer, President and Chief Executive Officer, Curis: Really appreciate that.

Conference Operator: Our next question comes from the line of Li Watsek from Cantor. Your line is now open.

Daniel Bronder, Analyst, Cantor: Hey, team, this is Daniel Bronder on for Li Watsek. Congrats on the progress. Just a question from us on the expected or potential update at ASH 26 on CLL. Just curious what kind of data we should be expecting, how many patients you expect to be able to share at that point, and how would you determine success at that early stage?

James Dentzer, President and Chief Executive Officer, Curis: Sure. So I’m gonna start answering that one, and then I’ll ask Dr. Hamdy to chime in as well. I mean, first and foremost, let’s not get too far ahead of ourselves. That’s in December, and I think as we get closer, we can provide more guidance on what we’re looking to talk about. I think at this stage of the game, it’s an execution story, right? We’re getting our sites open, we’re enrolling patients and hoping to be in a position that we’ve got some data to talk through in December. This is more about our plans and our expectations at this point. As we get closer to the conference, of course, we can narrow that down and talk a little more specifically.

The second part of your question of what would define success in this first proof of concept study, that’s a pretty wide-ranging one, and I might ask Dr. Hamdy to chime in on his thoughts. Ahmed?

Dr. Ahmed Hamdy, Chief Medical Officer, Curis: Sure. Thanks, Jim. Well, I mean, as Jim mentioned earlier, we’re trying to change the CLL treatment paradigm. As mentioned, BTK inhibitors only gets patients to partial responses with MRD positivity. We’re aiming hopefully to deepen that response and see that patients are going in the right direction towards a complete remission and hopefully MRD negative. We still don’t understand the kinetics of response in the combination where we are aiming to inhibit both pathways, the BCR signaling pathway and the TLR pathway, aiming to inhibit the NF-κB pathway, which is driving the disease at a much deeper level.

We have to dose a lot more patients to understand how fast that conversion from PR to CR happens, and I don’t intend to venture there just yet, but I’m quite hopeful that by ASH, we will have some meaningful data to present.

James Dentzer, President and Chief Executive Officer, Curis: Yeah. Let me expand on that a little bit more because I know at least for some of the investors who may be listening to this call, a little reminder is helpful. As Dr. Hamdy mentioned, we know there are two pathways driving disease in these patients, the BCR pathway and the TLR pathway. We know that historically, the standard of care is BTKI. Right? BTKI blocks the BCR pathway, and it works. Right? You’re blocking one of the two pathways driving diseases. That said, it’s also why patients are only getting partial response. They’re not getting complete remission because they’re only blocking one of the two pathways.

What we’ve seen in our previous studies and what we’re certainly seeing in our ongoing study in primary PCNSL, you know, another NHL subtype that’s standard of care is BTKI. If you add emavusertib to it, if you add a blockade of the TLR pathway on top of the blockade of the BCR pathway, you get deeper responses. We’ve seen complete remission. We’ve seen time-limited treatment. Our goal is to see if we can repeat that success across all five of the subtypes of NHL where BTKI gets used. The biggest of them by far is, of course, CLL. To Dr. Hamdy’s point, we’re very excited about getting into that study and seeing what effect we can have. At this stage, we’re learning.

The mechanism tells us that it should work, our previous studies tell us it should work, and we can’t wait to see the data, frankly. I hope that longer explanation is helpful.

Daniel Bronder, Analyst, Cantor: May I ask a follow-up?

James Dentzer, President and Chief Executive Officer, Curis: Please, of course.

Daniel Bronder, Analyst, Cantor: Have you dosed your first patients yet in this study?

James Dentzer, President and Chief Executive Officer, Curis: We haven’t disclosed that yet. What we are saying for now is that we are in the process of initiating the study. We’ve got our sites opening up in the U.S. and Europe, and our hope is to have data by the time we get to ASH, and we’re gonna try and get out of the path of month-by-month reporting on where are we in enrollment, if that’s all right.

Daniel Bronder, Analyst, Cantor: Sure. Thank you so much.

James Dentzer, President and Chief Executive Officer, Curis: Great. Thank you. I really appreciate it.

Conference Operator: There are no further questions at this time. I will now turn the call over to Jim Detzer. Please continue, sir.

James Dentzer, President and Chief Executive Officer, Curis: Thank you. Thank you everyone for joining today’s call. 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, the NCI, and the academic community for their ongoing collaboration and support. We look forward to updating you again soon. Operator?

Conference Operator: Thank you. Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.