Earnings Call Transcript - CRIS Q1 2026

Operator, Operator

Good afternoon, ladies and gentlemen, and welcome to the Curis First Quarter 2026 Business Update Conference Call. This call is being recorded on Tuesday, May 12, 2026. I would now like to turn the conference over to Diantha Duvall, Chief Financial Officer. Please go ahead.

Diantha Duvall, Chief Financial Officer

Thank you, and welcome to the Curis First Quarter 2026 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 first 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 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 now like to turn the call over to Jim.

James Dentzer, President & Chief Executive Officer

Thank you, Diantha. Good afternoon, everyone, and welcome to our first 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 non-Hodgkin lymphoma subtypes. As a reminder, the TakeAim Lymphoma study is a single-arm registrational study with an objective response rate (ORR) endpoint that is evaluating emavusertib in combination with ibrutinib after a patient has progressed on BTKi therapy. After collaborative discussions with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), we expect the study to support accelerated submissions in both the U.S. and Europe. We anticipate providing updated emavusertib clinical data from the TakeAim Lymphoma combination study with ibrutinib in patients with relapsed/refractory primary CNS lymphoma in the first half of 2027. 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 year we engaged with a number of key opinion leaders who were excited and highly supportive about expanding our emavusertib studies into additional non-Hodgkin lymphoma subtypes. They were especially interested in exploring emavusertib's potential to fundamentally change the treatment paradigm for chronic lymphocytic leukemia (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 help patients achieve objective responses. However, these responses are typically partial responses, not complete remissions. The result is that patients treated with a BTK inhibitor often need to remain on it chronically. Additionally, because they never achieve complete remission, many of these patients develop BTKi-resistant mutations and ultimately their disease progresses. We're 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 minimal residual disease (MRD). We anticipate dosing the initial five patients in the TakeAim CLL combination study with zanubrutinib by mid-2026, and we expect to have initial data in December. In January, one of our collaborators, Dr. Patrick Grierson of the Siteman Cancer Center at Washington University in St. Louis, presented a poster with initial clinical data in gastric and esophageal cancer at the ASCO Gastrointestinal Cancer Symposium. In that study, patients are treated with emavusertib in combination with FOLFOX and anti-PD-1 therapy with or without Herceptin as first-line therapy for metastatic or unresectable gastroesophageal cancers. The initial data showed results for 16 evaluable patients, demonstrating both a manageable toxicity profile and encouraging preliminary results. As you can see, we had a very productive quarter and look forward to an exciting 2026 as we advance our registrational study in primary CNS lymphoma and our proof-of-concept study in CLL. With that, I'll turn the call back over to Diantha for the financial update.

Diantha Duvall, Chief Financial Officer

Thank you, Jim. Curis reported a net loss of $24.2 million, or $1.25 per share, for the first quarter of 2026, as compared to a net loss of $10.6 million, or $1.25 per share, for the same period in 2025. The increase in net loss was primarily due to a change in fair value of warrant liabilities associated with the January 2026 PIPE financing. Research and development expenses were $6.4 million for the first quarter of 2026 as compared to $8.5 million for the same period in 2025. The decrease was primarily attributable to lower employee-related and manufacturing costs. General and administrative expenses were $5.1 million for the first quarter of 2026 as compared to $4.0 million for the same period in 2025. The increase was primarily attributable to expenses associated with the January 2026 PIPE financing, partially offset by lower employee-related costs. Curis' cash and cash equivalents as of March 31, 2026, were $15 million, and together with anticipated 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 the company's planned operations into the second half of 2027. With that, I'd like to open the call for questions.

Operator, Operator

Your first question comes from Sara Nik with H.C. Wainwright.

Sara Nik, Analyst (H.C. Wainwright)

Regarding the CLL study, you guided to announcing dosing of the first five patients by midyear. I was wondering if you could provide, as of today, how many patients have been dosed so far? And maybe any color on the current pace of site activation and enrollment?

James Dentzer, President & Chief Executive Officer

Thanks, Sara. We are trying to move away from providing patient-by-patient updates because five patients is already a small number. That said, we are confident we are on track to hit our target. Site activation and patient consent are progressing as planned, and we look forward to providing an update mid-summer.

Operator, Operator

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

Yale Jen, Analyst (Laidlaw & Co.)

In terms of PCNSL, you mentioned you're going to have an update in the first half of '27. I wonder whether that update will relate to data or simply enrollment status, or any other color?

James Dentzer, President & Chief Executive Officer

Thanks for the question. On PCNSL, our expectation is that we could be in a position to be fully enrolled in the study in 2027. Therefore, our expectation would be that we could have a substantial update on enrollment in the first half of 2027. Right now we're a long way from that point, and we'll continue to provide updates as we progress through the year. At this stage, I'd say we're cautiously optimistic, we are on track, and we look forward to providing that discussion with the full data set in 2027.

Yale Jen, Analyst (Laidlaw & Co.)

Maybe just to follow up on that. In terms of the current enrollment situation, I know it's very lumpy, but overall are things within your expectation, or are they either better or worse at this moment?

James Dentzer, President & Chief Executive Officer

You're exactly right — enrollment is lumpy, which is to be expected in an ultra-orphan patient population where there simply are not many patients. Some months we'll enroll none, and other months we might enroll two or three. That lumpiness is spot on. If you take a step back and look at the trend over time, we continue to see performance in line with our expectations and excitement among investigators remains strong. So yes, we are on track to hit our enrollment targets for an update in the first half of 2027, and we'll provide updated guidance as the year progresses.

Operator, Operator

The next question comes from Kripa Devarakonda with Truist.

Anna (on for Kripa Devarakonda), Analyst (Truist)

This is Anna on for Kripa. Two questions on CLL. You mentioned you're evaluating two doses to satisfy Project Optimus. Given the small sample size, do you expect any meaningful differences in the safety profile when adding emavusertib to these combinations? And regarding the CLL standard of care, could you remind us how you're differentiating there?

James Dentzer, President & Chief Executive Officer

Yes. As part of our discussions with FDA and EMA, they were clear that we need to include data on both 100 mg and 200 mg in our submissions, which we will do. I don't anticipate major safety differences between 100 mg and 200 mg. As you may recall, we have dosed emavusertib as high as 500 mg in earlier trials, so we expect the safety profile to be manageable at both 100 mg and 200 mg. The key point is to confirm that 200 mg is an appropriate starting dose and that patients have the option to dose up or down from a safety perspective as needed. I'll ask Dr. Hamdy to comment specifically on CLL.

Ahmed Hamdy, M.D., Chief Medical Officer

Thanks for the question. In CLL, while BTK inhibitors and BCL-2 inhibitors have made a meaningful difference, the problem is many patients need chronic dosing for extended periods, which can lead to resistance, mutations, and toxicities such as cardiovascular events, bleeding, and bone marrow suppression — the latter being particularly challenging for CLL patients. The current unmet need in CLL is achieving treatment-free remission. Most patients on monotherapy do not achieve a complete remission or MRD-negative status that would allow them to stop treatment. BTK inhibitors act by inhibiting the B-cell receptor (BCR) signaling pathway and thereby reduce NF-kappaB activation, which drives disease. However, because patients often do not reach CR or MRD-negative status, there is preclinical evidence from key opinion leaders showing constitutive activation of NF-kappaB through Toll-like receptor (TLR) pathways, which emavusertib inhibits. The concept of combining emavusertib with a BTK inhibitor is to achieve a more profound inhibition of NF-kappaB, and hopefully see more complete remissions than with BTK inhibitor monotherapy. Other approaches in the space have combined BTK inhibitors with BCL-2 inhibitors and anti-CD20 antibodies; while some of those combinations have shown higher CR and MRD rates, they often come with significant toxicity, particularly bone marrow suppression and infections. From our experience combining emavusertib with ibrutinib in multiple patients, we have not seen additive toxicities or bone marrow suppression. We believe our combination is differentiated and could represent a paradigm shift in how CLL is treated by inhibiting two key nodes in the pathway activating the disease. I hope that helps.

Operator, Operator

We have a question from Boris Peaker with Jones.

Danya Ben-Hail (on for Boris Peaker), Analyst (Jones)

This is Danya for Boris. My first question is a follow-up on the CLL trial. What specific signs of activity are you looking for in the initial patients to validate this dual blockade you've been discussing?

James Dentzer, President & Chief Executive Officer

That's a great question and probably best addressed by Dr. Hamdy. Ahmed, would you like to take that?

Ahmed Hamdy, M.D., Chief Medical Officer

I'm sorry, I didn't hear the last part of the question clearly. Could you repeat it?

Danya Ben-Hail (on for Boris Peaker), Analyst (Jones)

Sure. What initial or specific signs of activity are you looking for in the first patients you'll be enrolling?

Ahmed Hamdy, M.D., Chief Medical Officer

Currently we're combining emavusertib with zanubrutinib in patients who are in partial remission on zanubrutinib. The idea is to see deepening of responses — to see patients progress toward complete remission and achieve undetectable MRD status, which could enable a treatment-free remission where patients can stop those drugs. That's the primary sign of meaningful activity we're looking for in the initial patients.

James Dentzer, President & Chief Executive Officer

Let me add a bit of context to that. In the early days, our immediate goal is to show that a patient who has plateaued on zanubrutinib — meaning their disease burden has decreased significantly but then leveled off — can show further reduction once emavusertib is added. Practically, a patient comes into the study on zanubrutinib in a partial remission, we add emavusertib, and we want to observe a downward trend in disease burden from that plateau. From a regulatory perspective, we of course hope to see significant reductions, including complete remissions or MRD negativity, and the potential for time-limited treatment. But in these initial patients, the key thing we're hoping to document is that patients who had plateaued can demonstrate further decreases in disease burden after adding the second agent. That would be an encouraging early signal.

Danya Ben-Hail (on for Boris Peaker), Analyst (Jones)

And just a final question: Are you discussing commercial partnerships for the AML program?

James Dentzer, President & Chief Executive Officer

Not yet. With the January financing, we've addressed the company's near-term capital needs, which gave us the ability to continue executing on the PCNSL registrational program and to add the CLL program. Right now, we're focused on generating clinical data in those indications. With additional resources in the future, we would like to add AML and progress toward a registrational path there. A partnership could certainly make sense at some point, and we have the typical industry discussions around opportunities, but our current priority is to use the resources we have to advance the registrational PCNSL study and the CLL proof-of-concept and to generate the data that will enable the next steps.

Operator, Operator

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

James Dentzer, President & Chief Executive Officer

Thank you, operator, and thank you, everyone, for joining today's call. And 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 National Cancer Institute (NCI) and the academic community for their ongoing collaboration and support. We look forward to updating you again soon.

Operator, Operator

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