Curis (CRIS) Q4 2025 Earnings Call Transcript

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DATE

Thursday, March 19, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — James E. Dentzer
• Chief Financial Officer — Diantha Duvall
• Chief Medical Officer — Ahmed M. Hamdy

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TAKEAWAYS

• Net Income -- $19.4 million, or $1.23 per share, driven by a $27.2 million one-time non-cash gain from the Erivedge sale to Oberland.
• Revenue Outlook -- Diantha Duvall said, "there will be no meaningful revenue" going forward after the wind-down of Erivedge royalties in November 2025.
• Net Loss (Full Year) -- $7.6 million, or $0.58 per share, a reduction from a $43.4 million loss, or $6.88 per share, previously reported.
• Research & Development Expenses -- $5.8 million for the quarter, down from $9.0 million due to lower manufacturing, employee, and clinical costs.
• General & Administrative Expenses -- $2.9 million for the quarter, an improvement from $3.4 million, primarily from lower employee-related expenses.
• Cash Position -- Cash and equivalents as of December 31, 2025, plus $20.2 million initial proceeds from a January 2026 PIPE and potential further $20.2 million upon milestone, are expected to fund operations into 2027.
• TakeAim Lymphoma (PCNSL) -- Registrational enrollment is "on track," with the company maintaining prior guidance of "12- to 18-month range from full enrollment."
• Emavusertib Combination Progress (AML Triplet Study) -- Five of eight evaluable patients achieved MRD conversion with triplet therapy (emavusertib, azacitidine, venetoclax).
• Pipeline Prioritization -- James E. Dentzer said, "we are definitely prioritizing NHL ahead of AML," specifying resources focused on PCNSL for registration and CLL for initial data generation.
• CLL Study Advancement -- Clinical sites were recently activated in the US and Europe, with initial proof-of-concept data targeted for presentation at the ASH Annual Meeting in December.
• Milestone-Linked PIPE Proceeds -- Up to $20.2 million in additional PIPE proceeds depend on announcing dosing of the fifth CLL patient in TakeAim CLL later in 2026.

SUMMARY

Curis (NASDAQ:CRIS) reported a sharp quarterly net gain due to a one-time Erivedge sale, signaling a strategic shift away from legacy revenue streams. The company confirmed eradication of recurring revenue, clarifying operational funding now relies on recent and milestone-based PIPE financing planned to sustain into 2027. The registrational TakeAim Lymphoma (PCNSL) trial and TakeAim CLL study are explicit priorities, with CLL site activation and initial results expected by December. Data from the AML triplet trial indicated that a majority of evaluable patients achieved MRD negativity, providing clinical momentum for ongoing development. Resource allocation and further clinical expansion in AML remain contingent upon additional capital raises, as stated by management.

• James E. Dentzer said, "we sold what was remaining to Oberland to clean it all up. We are now completely independent of the Erivedge stream," emphasizing an operational pivot from legacy assets.
• Diantha Duvall confirmed, "Revenue effectively ended in November 2025," and noted the 15% of royalties no longer impact cash flows.
• Initial data from the TakeAim CLL proof-of-concept study are planned for the ASH conference, with the patient dosing event tied directly to PIPE milestone funding.
• On clinical risk management, Dentzer stated, "the bulk of our spend is going toward PCNSL, and in these early days CLL is much smaller, but I imagine that over time that will get larger," highlighting a dynamic resource approach as trials progress.

INDUSTRY GLOSSARY

• BTK inhibitor (BTKi): Bruton’s tyrosine kinase inhibitor, a therapy standard in CLL and NHL targeting the B-cell receptor pathway.
• PCNSL: Primary central nervous system lymphoma, a rare subtype of non-Hodgkin lymphoma targeted by Curis’s registrational study.
• MRD: Measurable residual disease, a clinical trial endpoint representing undetectable disease by sensitive assays.
• ASH: American Society of Hematology, annual scientific meeting for hematologic research disclosures.
• PIPE: Private investment in public equity, a financing mechanism referenced as Curis’s January 2026 funding source.

Full Conference Call Transcript

James E. Dentzer: Thank you, Diantha. Good afternoon, everyone, and welcome to Curis, Inc.’s fourth quarter business update call. We continue to make steady progress in our TakeAim Lymphoma study in primary CNS lymphoma, one of the rarest and most difficult to treat of the NHL subtypes. As a reminder, the TakeAim 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 the FDA and EMA, we expect the study to support accelerated submissions in both the US 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 US and Europe and expect to have initial data at the ASH Annual Meeting in December. With that, let us 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 two cohorts where patients received emavusertib for either seven or fourteen days in a 28-day cycle in addition to their azacitidine and venetoclax treatment. In this study, five of eight evaluable patients were able to achieve MRD conversion; that is, they were able to convert from MRD positive to undetectable disease. We are 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 we look forward to a very exciting 2026 as we are advancing our registrational study in PCNSL and initiating our proof-of-concept study in CLL. With that, I will turn the call over to Diantha for the financial update.

Diantha Duvall: Thank you, Jim. Curis, Inc. reported net income of $19.4 million, or $1.23 per share, for Q4 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 2025 is due to a $27.2 million one-time non-cash gain attributable to our sale of Erivedge to Oberland. Curis, Inc. reported a net loss of $7.6 million, or $0.58 per share, for the year ended 12/31/2025, 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 Q4 2025, as compared to $9.0 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 12/31/2025, as compared to $38.6 million for the same period in 2024. General and administrative expenses were $2.9 million for Q4 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 $14.0 million for the year ended 12/31/2025, as compared to $16.8 million for the same period in 2024.

Curis, Inc.’s cash and cash equivalents as of 12/31/2025, 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 fifth CLL patient in our TakeAim CLL study, expected later this year, should enable our planned operations into 2027. We will now open for questions.

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 are using a speaker phone, please lift the handset before pressing any keys. One moment please for your first question.

Operator: Our first question comes from the line of Kripa Devarakonda from Truist Securities. Your line is now open.

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

James E. Dentzer: Sure. Thanks for the question, and thanks for calling in. As you can imagine, we are very thoughtful about how we are prioritizing our resources. The January financing puts us on a very solid course, but we are still prioritizing our resources to be as efficient as we can in our spend. With that said, we are definitely prioritizing NHL ahead of AML. Right now, we have a dual-pronged strategy where we are pushing forward very aggressively in PCNSL—that is 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 registration approval, and we are moving ahead right on track on that one. With CLL, we have just started that study. In terms of spend, I would say the bulk of our spend is going toward PCNSL, and in these early days CLL is 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 toward 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 is when we start to look at AML. Right now, 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.

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

Yale Jen: Great. Thanks a lot, and I 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 us any updates at this moment? Then I have a follow-up.

James E. Dentzer: Sure. We are trying not to give enrollment on PCNSL other than we are on track for what we have suggested. As you all know, it is very hard to find these patients. We get a patient or two a month, but it is pretty choppy. You might go one month where you do not get any patients, and then the next month you get three. I would say right now we are enrolling patients, and on balance I think everything is going according to plan. If we are correct, I have said in the past that we are somewhere in that 12- to 18-month range from full enrollment.

That would place us at full enrollment with the potential to file after six months of following patients somewhere in the 2027 range. We could well be in a position by the end of the year that we are really close to that full enrollment number, and we have some nice data to talk about. But I do not expect we are going to have a whole lot to say ahead of then.

Yale Jen: Okay. Great. That makes a lot of sense. Then maybe just a quick question for modeling for next year. Given that you have this $27 million non-cash item as well as 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.

Diantha Duvall: Sure. So, Yale, that is correct. We will have no meaningful revenue. Revenue effectively ended in November 2025. From a cash flow perspective, remember that we had sold 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. There will be no revenue and the remaining 15% of cash flows, but it is not a meaningful impact to cash flows.

James E. Dentzer: Yes. 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 sold what was remaining to Oberland to clean it all up. We are now completely independent of the Erivedge stream.

Yale Jen: Okay. Great. That is very helpful, and congrats with the good balance sheet and the advance of programs forward.

James E. Dentzer: Thank you. We really appreciate that.

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

Tanya Brown: Hey, team. This is Tanya Brown around for Li. Congrats on the progress. Just a question from us on the expected or potential update at ASH 2026 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 you would determine success at that early stage?

James E. Dentzer: Sure. I am going to start answering that one, and then I will ask Dr. Hamdy to chime in as well. First and foremost, let us not get too far ahead of ourselves. That is in December, and I think as we get closer we can provide more guidance on what we are looking to talk about. At this stage of the game, it is an execution story. We are getting our sites open, we are enrolling patients, and hoping to be in a position that we have 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—what would define success in this first proof-of-concept study—that is a wide-ranging one, and I might ask Dr. Hamdy to chime in on his thoughts.

Ahmed M. Hamdy: Sure. Thanks, Jim. As Jim mentioned earlier, we are trying to change the CLL treatment paradigm. BTK inhibitors only get patients to partial responses with MRD positivity. We are aiming to deepen that response and see that patients are moving toward a complete remission and, hopefully, MRD negativity. We still do not 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-kappa B pathway, which is a driver of 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 do not intend to venture there just yet, but I am quite hopeful that by ASH we will have some meaningful data to present.

James E. Dentzer: 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. Historically, the standard of care is BTKi. BTKi blocks the BCR pathway, and it works; you are blocking one of the two pathways driving disease. That said, it is also why patients are only getting partial response; they are not getting complete remission because they are only blocking one of the two pathways.

In our previous studies, and certainly in our ongoing study in primary CNSL—another NHL subtype where 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 have seen complete remission, and we have 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 CLL. We are very excited about getting into that study and seeing what effect we can have. At this stage, we are learning. The mechanism tells us that it should work.

Our previous studies tell us it should work. We cannot wait to see the data, frankly. I hope that longer explanation is helpful.

Tanya Brown: May I ask a follow-on?

James E. Dentzer: Please. Of course.

Tanya Brown: Have you dosed your first patients yet in this study?

James E. Dentzer: We have not disclosed that yet. What we are saying for now is that we are in the process of initiating the study. We have sites opening in the US and Europe, and our hope is to have data by the time we get to ASH. We are going to try to get out of the path of month-by-month reporting on where we are in enrollment, if that is alright.

Tanya Brown: Thank you so much.

James E. Dentzer: Great. Thank you. I really appreciate it.

Operator: There are no further questions at this time. I will now turn the call over to James E. Dentzer. Please continue, sir.

James E. Dentzer: Thank you, and 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, Inc. 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?

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

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