Curis (NASDAQ:CRIS) expects to complete enrollment in its registrational study of emavusertib for primary central nervous system lymphoma by the end of 2027 and potentially submit a U.S. application for accelerated approval in 2028, executives said on the company’s third-quarter business update call.
The company also plans to report initial data by year-end from a separate study in chronic lymphocytic leukemia, or CLL. Curis reported $5 million in cash and cash equivalents at the end of September and said that, together with financing obtained in October, it expects to fund existing operations into 2027.
Lymphoma study advances toward enrollment goal
Curis is evaluating emavusertib in combination with ibrutinib, a BTK inhibitor, in patients with relapsed or refractory primary central nervous system lymphoma, or PCNSL. The company reported updated results for patients who had not previously received a BTK inhibitor and for patients whose disease had progressed while they were taking one.
Among seven BTK inhibitor-naive patients, six responded, for a response rate of 86%, President and CEO Jim Dentzer said. Among 39 patients whose disease had progressed on a BTK inhibitor, 10 responded to the combination, a rate of 26%.
Dentzer said published studies of BTK inhibitors in PCNSL have generally shown response rates of 39% to 67%. He said the updated results support the potential for accelerated approval submissions in the U.S. and Europe. The comparison cited by Dentzer was with published studies, not a direct comparison within the Curis trial.
Enrollment has been uneven because the disease is rare, but the company remains confident it can complete the study by the end of 2027, Dentzer said. Curis would likely follow patients for about six months after the last patient is enrolled before filing a new drug application for accelerated approval, putting a potential filing in 2028.
Dentzer said the study needs approximately 10 to 15 more patients and that the company’s response-rate hurdle is generally 20%. He said a regulatory data package would aim to include partial and complete responses and their duration.
Initial CLL data expected by year-end
Curis has opened 11 clinical sites and enrolled 12 patients in its proof-of-concept CLL study, Dentzer said. The study is testing the addition of emavusertib in patients receiving BTK inhibitor monotherapy who have achieved partial remission but not complete remission or undetectable minimal residual disease.
Dentzer said the company hopes the combination can produce deeper responses and potentially allow time-limited treatment. He emphasized that the initial readout will look for evidence of clinical activity, with any tumor reduction also of interest.
Patients entered the study at different times, so the data will vary in maturity. Some patients may have received three or four treatment cycles, while others may have data from only one or two, Dentzer said. He did not specify how many patients would be included in each group or where the data would be presented.
Some safety data will be included, Dentzer said, though he did not detail the full contents of the planned release. The company is also collecting data on lymphocytosis, but he said it does not yet know whether it will observe that effect.
Quarterly loss widens
Curis reported a third-quarter net loss of $8.1 million, or $1.94 per share, compared with a loss of $7.7 million, or $9.86 per share, a year earlier, CFO Diantha Duvall said.
Research and development expenses fell to $5.6 million from $6.4 million, primarily because of lower employee-related costs, partly offset by higher clinical costs. General and administrative expenses declined to $3.2 million from $3.7 million, primarily reflecting lower employee-related costs, partly offset by higher legal costs.
For the nine months ended Sept. 30, Curis reported a net loss of $40.9 million, compared with $26.9 million in the same period of 2025. The company had approximately 4.1 million common shares outstanding at the end of September, Duvall said.
About Curis (NASDAQ:CRIS)
Curis, Inc. is a clinical-stage biotechnology company focused on developing innovative therapeutics for the treatment of cancer. The company’s research and development activities center on targeted therapies designed to address biological pathways involved in tumor growth and immune regulation. Curis’ lead investigational product is emavusertib, an oral inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4). The company has evaluated emavusertib in clinical studies for hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndromes and certain forms of non-Hodgkin lymphoma.
