Curis (CRIS) Q4 2025 Earnings Call Transcript

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

Et Call Participants

Chief Executive Officer — James E. DentzerChief Financial Officer — Diantha DuvallChief Medical Officer — Ahmed M. Hamdy Need a quote from a Motley Fool analyst? Email [email protected] 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. Curis (CRIS 7.14%) 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.