Curis (CRIS) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 12, 2026

CALL PARTICIPANTS

• President and Chief Executive Officer - Jim Dentzer
• Chief Development Officer - Dr. Jonathan Zung
• Chief Medical Officer - Dr. Ahmed Hamdy

TAKEAWAYS

• Response Rate (BTKi-naive) -- 86%, with 6 of 7 patients achieving a response in the TakeAim Lymphoma study for PCNSL.
• Response Rate (Salvage-line) -- 26%, with 10 of 39 patients responding after they had already progressed on BTK inhibitor monotherapy.
• Net Loss -- $8.1 million for the third quarter, reflecting slightly higher costs compared to $7.7 million in the third quarter of 2025.
• Net Loss Per Share -- $1.94, compared to $9.86 per share in the prior year, influenced by changes in the common stock outstanding.
• Nine-Month Net Loss -- $40.9 million, compared to $26.9 million for the same period in 2025.
• R&D Expenses -- $5.6 million, driven by lower employee-related costs partially offset by an increase in clinical costs.
• G&A Expenses -- $3.2 million, reflecting lower employee-related costs and higher legal expenses.
• Cash and Cash Equivalents -- $5 million as of Sept. 30, 2026, which the company expects will fund operations into 2027.
• CLL Enrollment -- 12 patients across 11 clinical sites, focusing on patients who achieved partial remission on monotherapy.
• CLL Data Timing -- expected by the end of 2026, representing the first proof-of-concept data for emavusertib in this indication.
• PCNSL Enrollment Target -- completion scheduled for 2027, with the company seeking 10 to 15 additional patients.
• NDA Submission Timeline -- 2028, following the requirement to follow patients for six months after the last patient is enrolled.
• BTKi Benchmark -- 39% to 67% response rates for BTK inhibitor monotherapy in published PCNSL studies, compared to 86% for the emavusertib combination.
• Common Stock Outstanding -- approximately 4.1 million shares as of Sept. 30, 2026.
• ORR Hurdle -- 20%, which serves as the general benchmark for registrational success in the PCNSL study.
• Study Maturity -- three or four cycles of data expected for some CLL patients at the time of the initial reporting by year-end.
• Salvage-line Patient Count -- 39, representing patients whose disease progressed while on treatment with a BTK inhibitor.
• BTKi-naive Patient Count -- 7, representing the patient subset used to evaluate frontline efficacy in PCNSL.
• 9-Month R&D Expenses -- $18.8 million, compared to $22.4 million for the same period in 2025.
• 9-Month G&A Expenses -- $11.4 million, compared to $11.2 million for the same period in 2025.

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RISKS

• Jim Dentzer stated, "the enrollment, as you know, has been choppy because it's very hard to find these patients," noting the difficulty of recruiting for an ultra-orphan disease like PCNSL.

SUMMARY

Curis, Inc. (NASDAQ:CRIS) reported updated clinical data for its lead oncology program, emavusertib, while outlining strategic timelines for regulatory submissions and data readouts. Management stated that combination therapy in primary CNS lymphoma (PCNSL) demonstrated objective response rates that exceed benchmarks for monotherapy. The company also initiated a study in chronic lymphocytic leukemia (CLL) to test the hypothesis that dual blockade of the BCR and TLR pathways can deepen patient responses. Financial results for the third quarter included a decrease in operating expenses alongside a confirmed cash runway into 2027 following recent financing activities.

• CEO Dentzer stated, "the combination of emavusertib plus BTKi appears to be better than BTKi alone," regarding the high response rate in treatment-naive patients.
• Management seeks to deepen clinical responses in CLL patients who achieve only partial remission on standard monotherapy.
• The company expects to file for accelerated approval in both the U.S. and Europe after completing enrollment in the registrational study.
• Initial CLL data will provide an update on anticancer activity and the potential for tumor reduction in the first 12 patients.
• Jim Dentzer noted that for salvage-line patients who fail frontline therapy and BTKi, emavusertib is helping them "reverse their disease," which is encouraging given their typically poor prognosis.

INDUSTRY GLOSSARY

• PCNSL: Primary Central Nervous System Lymphoma, a rare and aggressive form of non-Hodgkin lymphoma.
• CLL: Chronic Lymphocytic Leukemia, a type of cancer that starts from cells that become certain white blood cells in the bone marrow.
• BTKi: Bruton's Tyrosine Kinase inhibitor, a class of drugs used to treat various B-cell malignancies.
• Emavusertib: An oral small-molecule IRAK4 kinase inhibitor currently in clinical development.
• ORR: Objective Response Rate, the proportion of patients with a reduction in tumor size of a predefined amount.
• NDA: New Drug Application, a formal proposal to the FDA to approve a new pharmaceutical for sale and marketing.
• MRD: Minimal Residual Disease, the small number of cancer cells that remain in the body after treatment.
• NHL: Non-Hodgkin Lymphoma, a group of blood cancers that includes PCNSL.
• BCR Pathway: B-cell receptor pathway, a signaling pathway critical for the survival of B-cell malignancies.
• TLR Pathway: Toll-like receptor pathway, a biological pathway that emavusertib is designed to block.

Full Conference Call Transcript

Operator: Good afternoon, ladies and gentlemen, and welcome to the Curis provides Third Quarter 2026 Business Update Conference Call. [Operator Instructions] This call is being recorded on Thursday, November 12, 2026. I would now like to turn the conference over to your host, Diantha Duvall.

Diantha Duvall: Thank you, and welcome to Curis' Third Quarter 2026 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 2026 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 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 now like to turn the call over to Jim.

James Dentzer: Thank you, Diantha. Good afternoon, everyone, and welcome to Curis' third quarter business update call. I'll start with PCNSL, our lead program and first NHL study. We continue to make steady progress in our TakeAim Lymphoma Study in 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 registrational study of emavusertib in combination with ibrutinib in patients with relapsed/refractory PCNSL. We reported updated data this quarter for 7 BTK-naive patients and 39 salvage-line patients, patients whose disease had progressed while on treatment with a BTK inhibitor.

The updated data show an 86% response rate in BTKi-naive patients with 6 of 7 patients achieving a response. For context, it's important to note that published studies of BTK inhibitors in PCNSL have generally shown response rates of 39% to 67%. Clearly, the combination of emavusertib plus BTKi appears to be better than BTKi alone. For salvage-line patients, those patients whose disease had progressed while taking a BTK inhibitor, the updated data show a 26% response rate with 10 of 39 patients responding when treated with the emavusertib plus BTKi combination after they had already progressed on BTKi monotherapy.

For context, patients who have failed both frontline therapy and BTKi have a very poor prognosis with many patients proceeding directly to hospice or best supportive care. That emavusertib is helping patients change that story and reverse their disease is very encouraging. In short, the updated data in both BTKi-naive and salvage-line patients provide further evidence of meaningful clinical activity and continue to support the potential for accelerated approval submissions in both the U.S. and Europe. We look forward to completing full enrollment in this registrational study on schedule in 2027. Now let's turn to CLL, our second NHL study, which was initiated earlier this year.

As you recall, last year, we engaged with a number of key opinion leaders about which NHL subtype to study after PCNSL. They were intrigued by our early data across multiple NHL subtypes and expressed a particular interest in exploring emavusertib's potential to fundamentally change the frontline treatment paradigm for CLL patients, where the current standard of care is BTK inhibitors. Over the last decade, BTK inhibitors have become standard of care in CLL and NHL because of their ability to block the BCR pathway and 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 2 biologic pathways driving CLL.

This dual blockade with BTKi blocking the BCR pathway and emavusertib blocking the TLR pathway can enable patients whose cancer 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 11 clinical sites open for enrollment with 12 patients on study, and we look forward to reporting initial data later this year. If the data in CLL are consistent with our previous NHL data, we would hope to see early evidence of anticancer activity that could ultimately lead to a reduction of tumor burden and deeper objective responses. I know our clinicians and especially our patients are excited about the potential of emavusertib to increase the efficacy of BTK inhibitors in frontline CLL. In summary, we have made meaningful progress across both NHL studies this year.

In PCNSL, our lead NHL program, the updated data show consistent efficacy and are very encouraging as we advance toward full enrollment and a potential first regulatory submission. And in CLL, our second NHL program, we remain on track to report initial clinical data by year-end, which is now only a few weeks away. With that, I'll turn the call back to Diantha for the financial update. Diantha?

Diantha Duvall: Thank you, Jim. Curis reported a net loss of $8.1 million or $1.94 per share for the third quarter of 2026 as compared to a net loss of $7.7 million or $9.86 per share for the same period in 2025. Curis reported a net loss of $40.9 million or $16.77 per share for the 9 months ended September 30, 2026, as compared to a net loss of $26.9 million or $43.82 per share for the same period in 2025. Research and development expenses were $5.6 million for the third quarter of 2026 as compared to $6.4 million for the same period in 2025. The decrease was primarily attributable to lower employee-related costs, partially offset by an increase in clinical costs.

Research and development expenses were $18.8 million for the 9 months ended September 30, 2026, as compared to $22.4 million for the same period in 2025. General and administrative expenses were $3.2 million for the third quarter of 2026, as compared to $3.7 million for the same period in '25. The decrease was primarily attributable to lower employee-related costs, partially offset by an increase in legal costs. General and administrative expenses were $11.4 million for the 9 months ended September 30, 2026, as compared to $11.2 million for the same period in 2025. Curis' cash and cash equivalents were $5 million as of September 30, 2026, and the company had approximately 4.1 million shares of common stock outstanding.

Based on our current operating plan, we believe that our existing cash and cash equivalents, along with the financing from October should enable us to fund our existing operations into '27. With that, I'd like to turn the call over for questions. Operator?

Operator: [Operator Instructions] We have our first question from Yale Jen with Laidlaw.

Yale Jen: Congrats on all the progress. Just two from us. The first one is that in terms of the 12 patients in the CLL study for the data release in December, how many of those potentially be available for reporting in terms of completing a certain number of treatment cycles? Then I have a follow-up.

James Dentzer: Okay. First, thank you, Yale, for joining the call. Appreciate it. So the 12 patients, as you can imagine, came on at very different time points. So our goal at this point in time is to report as much data as we can at the time of the release. And that means, of course, we'll have more mature data, patients who have been on drug for 3 or 4 cycles as well as potentially some patients who have only got data in for a cycle or 2. Exactly how many patients fit in which category, of course, we're going to release the data in real time, and we'll give as much data as we have. I hope that's helpful.

Yale Jen: Okay. Yes, it does. And maybe also a related question is that in terms of the data release, actually two sub questions here. One is what venue you may have to report that? And second one, what's the context of the data, whether there will be safety, maybe biomarker, maybe some response rate, whatnot? Maybe give us a little bit sort of color in advance.

James Dentzer: Sure. So the venue, I think stay tuned. I think we would anticipate reaching out and making it widely available no matter which method we choose to put that out. So I'd say stay tuned. And the second part is what data we're going to have. As I said in the remarks earlier, what we're really hoping to see first and foremost is a combination of what we've seen in our other NHL studies and frankly, what BTK inhibitor studies have shown. We want to see that we've got signs of clinical activity. Does it work in CLL, the same way it works in other NHL subtypes.

We expect it does, and we want to see data that shows that we've got activity. And if that activity can result in tumor reduction, of course, or the potential to eventually get there, that would be ideal. How long it takes to see tumor reduction remains to be seen. But what we're looking for at this stage of the game is, of course, full stop, can this drug, can emavusertib add efficacy in BTK with BTK in CLL the same way it does in PCNSL. And if that's true, of course, it's going to be very exciting.

Yale Jen: So would that be some biomarker data or maybe even additional safety data to confirm that?

James Dentzer: So I think certainly, there would be some safety data. But exactly which data we're going to be presenting, I'll hold that for the presentation. But as a reminder, I think what other studies have shown in BTK is evidence of lymphocytosis. Can we see that? We don't know yet. We're collecting those data, but we'll certainly give an update on whatever we do see as we get closer to the end of the year.

Operator: We have our next question from Boris Peaker with JonesTrading.

Danya Ben-Hail: This is Danya for Boris. I have one question about the PCNSL program. Is the rate of enrollment keeping up with your expectations? And when should we expect full enrollment?

James Dentzer: Thank you. Yes, the enrollment, as you know, has been choppy because it's very hard to find these patients. It is an ultra-orphan disease. But it's been very consistent since we started the study. So at this point, we feel very confident that we are getting close to full enrollment. We expect to be fully enrolled in the study by the end of 2027. And as long as our response rate holds, we should have a data set that's compelling for an NDA submission for accelerated approval. But I think given the enrollment rate that we've seen so far, I think we can reiterate our confidence that 2027 is the year we achieve full enrollment in that registrational study.

Danya Ben-Hail: And soon after -- within a few months, you would expect to collect the data?

James Dentzer: Yes. So as you know, we generally follow the patients for a couple of months. Typically, we are getting responses in the first few cycles. But what we'd want to do post enrollment is follow the patients for probably 6 months from last patient in before we would file for NDA for the accelerated approval. So I think we would anticipate a full enrollment in 2027 and assuming that, that happens, filing it in 2028. Does that make sense?

Operator: We have our next question from Sara Nik with H.C. Wainwright.

Sara Nik: I guess kind of following up on the previous question. I know you expect enrollment to complete by end of 2027. Are you also expecting to provide any update on the CR rate or duration of response then before the NDA filing as well?

James Dentzer: So I think we would certainly be tracking responses as well as duration of responses as we go as we have so far in all of our releases. I think the real question is we only need a handful more patients, 10 to 15 more patients is what we're looking to get. And only a couple of responses are needed in order to hit the hurdle. As you know, our hurdle is generally a 20% ORR, and we've been running better than that so far. So the real question is, do those responses come early or in the next 15 patients, are they the first 3 patients, the last 3 patients or somewhere in the middle.

I think for this purpose, what I would assume is it's spread out evenly. It will be random. But depending upon when those responses come, that's, of course, when we're going to start tracking duration. And when we go to package the data for FDA and for EMA, of course, we'd be looking to put together as complete a package we can that would include responses broken down by PR by CR with duration of each. Does that make sense?

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

James Dentzer: Thank you, Vanessa, and thank you, everyone, for joining today's call. And as always, thank you to the patients and their families participating in our clinical trials to the investigators and clinical site teams for their contributions and commitment and to our team here at Curis for their hard work and commitment. Also to our partners at Aurigene, the NCI and the academic community for their ongoing collaboration and support. We look forward to updating you all again very soon. Vanessa?

Operator: Thank you. Ladies and gentlemen, this concludes today's conference. We thank you for your participation, and you may now disconnect.

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