Curis (NASDAQ:CRIS) executives used the company’s fourth-quarter 2025 business update call to outline progress across its clinical pipeline centered on emavusertib, while also detailing a year-end financial position that management said supports operations into the second half of 2027.
Registrational study focus in primary CNS lymphoma
President and CEO Jim Dentzer said Curis continues to make “steady progress” in its Take Aim Lymphoma study in primary CNS lymphoma (PCNSL), which he described as one of the rarest and most difficult-to-treat non-Hodgkin lymphoma (NHL) subtypes. The trial is a single-arm registrational study with an objective response rate (ORR) endpoint evaluating emavusertib in combination with ibrutinib after patients have progressed on BTK inhibitor (BTKI) therapy.
In the Q&A session, Dentzer declined to provide specific enrollment numbers, but said the company is “on track” with prior expectations. He characterized recruitment as uneven given the scarcity of eligible patients, noting that enrollment can vary month to month. Dentzer reiterated a prior estimate that Curis could be in the “12-18-month range” from full enrollment, and suggested that—if the timeline holds—full enrollment followed by approximately six months of patient follow-up could place a potential filing timeframe “somewhere in the 2027 range.”
CLL proof-of-concept study aims to deepen responses on BTK inhibitors
Curis also highlighted plans to expand emavusertib into additional NHL subtypes, with Dentzer focusing on chronic lymphocytic leukemia (CLL) as a major opportunity. He said key opinion leaders have been supportive of exploring whether adding emavusertib to BTKI therapy could help patients move beyond typical partial responses and potentially achieve complete remission or undetectable minimal residual disease (MRD), enabling time-limited treatment.
Dentzer framed the rationale around dual pathway inhibition, describing BTK inhibitors as targeting one pathway while emavusertib would add blockade of another pathway to drive deeper disease control. He said the company has begun activating clinical sites in the U.S. and Europe for a proof-of-concept study enrolling patients currently on BTKI monotherapy who have achieved partial remission but have been unable to reach complete remission or undetectable MRD.
Management said it expects to have initial data to share at the American Society of Hematology (ASH) annual meeting in December. However, when asked about the amount of data that might be available and how success would be defined, Dentzer emphasized that the near-term focus is execution—opening sites and enrolling patients—and said the company would provide more specific guidance closer to the meeting.
Chief Medical Officer Dr. Ahmed Hamdy said Curis is seeking to “deepen that response” in CLL and move patients toward complete remission and MRD negativity, while noting the company does not yet fully understand response kinetics for the combination. He said more patient dosing will be needed to understand how quickly a conversion from partial response to complete response occurs, but added he is “quite hopeful” Curis will have meaningful data by ASH.
Curis did not disclose whether the first patient has been dosed in the CLL study, and Dentzer said the company intends to avoid month-by-month enrollment updates.
AML: early MRD conversion signal in triplet study
Dentzer also reviewed data Curis presented at ASH in December related to an ongoing AML triplet study evaluating emavusertib with azacitidine and venetoclax in AML patients who achieved complete remission on azacitidine/venetoclax but remained MRD positive.
The data were from the first two cohorts, in which patients received emavusertib for either seven or 14 days in a 28-day cycle alongside azacitidine and venetoclax. Dentzer said five of eight evaluable patients achieved MRD conversion, meaning they converted from MRD positive status to undetectable disease. He said the company is encouraged by the initial findings and the potential of the combination.
Resource priorities: NHL ahead of AML
In response to a question about prioritizing across programs, Dentzer said Curis is focused on allocating resources efficiently, and confirmed the company is prioritizing NHL over AML. He described a “dual-pronged strategy” within NHL: pushing aggressively in PCNSL as the registrational effort while initiating the CLL study, which he noted could expand over time.
Dentzer said most spending is currently directed toward the PCNSL registrational program, with CLL smaller in the early phase. He added that AML work is more focused on analysis and planning until additional resources are available.
Financial results and cash runway
Chief Financial Officer Diantha Duvall reported net income of $19.4 million, or $1.23 per share, for the fourth quarter of 2025, compared with a net loss of $9.6 million, or $1.25 per share, in the same period of 2024. She attributed the fourth-quarter net income to a $27.2 million one-time non-cash gain related to the sale of Erivedge to Oberland.
For the full year ended Dec. 31, 2025, Curis reported a net loss of $7.6 million, or $0.58 per share, compared with a net loss of $43.4 million, or $6.88 per share, in 2024.
- R&D expense was $5.8 million in Q4 2025 versus $9.0 million in Q4 2024, driven primarily by lower manufacturing, employee-related, and clinical costs. Full-year R&D expense was $28.3 million versus $38.6 million.
- G&A expense was $2.9 million in Q4 2025 versus $3.4 million in Q4 2024, primarily due to lower employee-related costs. Full-year G&A expense was $14.0 million versus $16.8 million.
Duvall said cash and cash equivalents as of Dec. 31, 2025, together with $20.2 million in initial gross proceeds received in January 2026 and potential gross proceeds of up to an additional $20.2 million from the exercise of January 2026 PIPE financing Series B warrants, should fund planned operations into the second half of 2027. She said the warrant exercise is tied to the public announcement of dosing of the fifth CLL patient in the Take Aim CLL study, which Curis expects later this year.
Responding to a question about revenue expectations, Duvall said Curis expects no meaningful revenue, noting that revenue effectively ended in November 2025. She added that Curis had previously sold rights to roughly 85% of Erivedge royalties to Oberland and then sold the remaining 15%, leaving the company “completely independent of the Erivedge stream.”
About Curis (NASDAQ:CRIS)
Curis, Inc is a biotechnology company focused on the discovery, development and commercialization of targeted small molecule and antibody therapeutics for the treatment of cancer. The company’s research centers on exploiting key signaling pathways and tumor microenvironment interactions to develop compounds with the potential to address unmet medical needs. Curis’ proprietary pipeline includes multiple programs at various stages of clinical and preclinical development, reflecting its emphasis on innovative oncology drug candidates.
Among Curis’ lead assets is CA-4948, an oral inhibitor of interleukin-1 receptor–associated kinase 4 (IRAK4) partnered with Ikena Oncology, which is being evaluated in hematologic malignancies and solid tumors.
