On November 6, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported its financial and operating results for the third quarter ended September 30, 2025.
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"We made good progress advancing our clinical studies in PCNSL, CLL, and AML this quarter. We continue to enroll PCNSL patients in the TakeAim Lymphoma study in both the BTKi-experienced and BTKi-naïve cohorts to enable accelerated approval filings in the US and EU. We are presenting three posters at the SNO annual meeting later this month, two in PCNSL and one in SCNSL. We are presenting at the ASH (Free ASH Whitepaper) annual meeting in December with initial data from the ongoing frontline AML triplet study evaluating different dosing regimens of emavusertib, venetoclax, and azacitidine. And, finally, we have filed the protocol with the FDA for our Phase 2 study of emavusertib + BTKi in CLL, we are working to activate clinical sites, and we expect to enroll our first patient in late Q4 or early Q1, with data expected at the ASH (Free ASH Whitepaper) annual meeting in December 2026. I am very pleased with the progress we have made across multiple ongoing studies in PCNSL, CLL, and AML," said James Dentzer, President and Chief Executive Officer.
Operational Highlights
NHL/CLL
Curis will report clinical data in Primary CNS Lymphoma (PCNSL) and Secondary CNS Lymphoma (SCNSL) in three presentations at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19-23:
PCNSL
Rapid Oral Presentation + Poster
Dr. Christian Grommes, Memorial Sloan Kettering Cancer Center, NY, NY
Analysis of Genetic Mutation Profile and CNS Pharmacokinetics in Relapsed/Refractory Primary CNS Lymphoma Patients Responding to Novel Emavusertib (IRAK4i) and BTKi Combination
PCNSL
Poster Presentation
Dr. Lakshmi Nayak, Dana-Farber Cancer Institute, Boston, MA
Preliminary Safety and Efficacy of Emavusertib (CA-4948) in Combination with Ibrutinib in Relapsed/Refractory Primary Central Nervous System Lymphoma Patients
SCNSL
Poster Presentation
Dr. Cecilia A. Merrigan, Mayo Clinic, Rochester, MN
Promising Efficacy Signal in Secondary CNS Lymphoma Patients Treated with Emavusertib and Ibrutinib
Curis continued to enroll relapsed/refractory (R/R) PCSNL patients in the Company’s TakeAim Lymphoma study which, as a result of discussions with the EMA and FDA, is intended to support filings for accelerated approval in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both the FDA and EMA in PCNSL.
Curis is initiating a Phase 2 clinical study of emavusertib in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL), with dosing of the first patient expected in late Q4 or early Q1. The goal of combining emavusertib with a BTKi is to improve upon the current standard of care (BTKi) with its limitations of partial responses and the need for chronic, life-long therapy. The combination of emavusertib with a BTKi has the potential to enable patients to achieve complete remission or undetectable minimal residual disease (uMRD) and the potential for time-limited treatment, which would be a paradigm shift in the management of CLL.
Leukemia
Curis will be presenting initial clinical data from the ongoing frontline AML triplet study in a poster presentation at the 67th ASH (Free ASH Whitepaper) Annual Meeting in December:
AML
Poster Presentation
Dr. Christina Papayannidi,
IRCCS Azienda Ospedaliero Universitaria di Bologna
Preliminary pharmacokinetic and MRD results from AML patients treated with 7- and 14-day dosing schedule of emavusertib added to combination therapy with azacitidine and venetoclax
The AML triplet study is evaluating the addition of emavusertib to the combination of azacitidine and venetoclax (aza-ven) in AML patients who have achieved complete remission on aza-ven but remain MRD positive (MRD+). The first two cohorts in the study evaluate patients who received emavusertib for 7 or 14 days in a 28-day cycle, in addition to their azacitidine and venetoclax treatment. The abstract, published on November 3, 2025, showed data with a July 2, 2025 data cut-off for 4 patients in the 7-day cohort and 6 patients in the 14-day cohort:
MRD conversion (positive to undetectable) was observed in 4 of 8 patients (50%)
1 additional patient achieved a 40% reduction in MRD from baseline as of data cut-off
No patients who remained MRD+ progressed on study.
Two dose-limiting toxicities (CPK increase and neutropenia) were observed in the 14-day cohort and both resolved
Solid Tumors
Curis will be presenting initial clinical data from a Phase 1 Investigator Sponsored Study (IST) evaluating emavusertib in combination with gemcitabine and nab-paclitaxel in metastatic or unresectable pancreatic ductal adenocarcinoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium on January 8-10, 2026:
PDAC
Poster Presentation
Dr. Patrick Grierson,
Siteman Cancer Center, Washington University in St Louis
A phase I trial of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC)
Corporate
Completed a registered direct offering and concurrent private placement extending cash runway into 2026.
Upcoming Presentations and Conferences
Updated PCNSL and SCNSL data will be reported in poster presentations at the 30th Annual Meeting of the Society for Neuro-Oncology on November 19-23, 2026
Initial clinical data in the frontline AML triplet study of emavusertib with azacitidine and venetoclax will be reported in a poster presentation at the 67th ASH (Free ASH Whitepaper) Annual Meeting on December 6-9, 2025
Initial clinical data from an Investigator Sponsored Study (IST) in pancreatic ductal adenocarcinoma (PDAC) will be reported at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium on January 8-10, 2026
Third Quarter 2025 Financial Results
For the third quarter of 2025, Curis reported a net loss of $7.7 million or $0.49 per share on both a basic and diluted basis as compared to $10.1 million or $1.70 per share on both a basic and diluted basis, for the same period in 2024. Curis reported a net loss of $26.9 million or $2.19 per share on both a basic and diluted basis, for the nine months ended September 30, 2025, as compared to a net loss of $33.8 million or $5.77 per share on both a basic and diluted basis for the same period in 2024.
Revenues were $3.2 million for third quarter of 2025, as compared to $2.9 million for the same period in 2024. Revenues were $8.3 million for the nine months ended September 30, 2025, as compared to $7.6 million for the same period in 2024. Revenues consist of royalty revenues from Genentech/Roche’s sales of Erivedge.
Research and development expenses were $6.4 million for the third quarter of 2025, as compared to $9.7 million for the same period in 2024. The decrease was primarily attributable to lower clinical, employee related, manufacturing, research, and consulting costs. Research and development expenses were $22.4 million for the nine months ended September 30, 2025, as compared to $29.6 million for the same period in 2024.
General and administrative expenses were $3.7 million for the third quarter of 2025, as compared to $3.8 million for the same period in 2024. The decrease was primarily attributable to lower employee related costs. General and administrative expenses were $11.2 million for the nine months ended September 30, 2025, as compared to $13.4 million for the same period in 2024.
Other expense was $0.8 million for the third quarter of 2025, as compared to other income of $0.5 million for the same period in 2024. The decrease was primarily attributable to an increase in the expense related to the sale of future royalties and a decrease in interest income. Other expense was $1.6 million for the nine months ended September 30, 2025, as compared to other income of $1.8 million for the same period in 2024.
Curis’s cash and cash equivalents totaled $9.1 million as of September 30, 2025, and the Company had approximately 12.7 million shares of common stock outstanding. We believe that our existing cash and cash equivalents, should enable us to fund our existing operations into the first quarter of 2026.
Conference Call and Webcast Information
Curis management will host a conference call today, November 6, 2025, at 4:30 p.m. ET, to discuss the business update and these financial results.
To access the live conference call, please dial 1-800-836-8184 from the United States or 1-646-357-8785 from other locations. To access the webcast login here shortly before 4:30 p.m. ET. The webcast can also be accessed on the Curis website at the Events and Presentations section of the Investors page.
(Press release, Curis, NOV 6, 2025, View Source [SID1234659565])