On August 5, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its financial and operating results for the second quarter ended June 30, 2025 (Press release, Curis, AUG 5, 2025, View Source [SID1234654783]).
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"We are pleased with our progress in the TakeAim Lymphoma study and are continuing to enroll PCNSL patients in both Part B (BTKi-experienced patients) and Part C (BTKi-naïve patients) to enable accelerated approval filings in the US and EU. We look forward to providing updated data later this year," said James Dentzer, President and Chief Executive Officer. "We are also excited to add a clinical study of emavusertib in combination with a BTK inhibitor in Chronic Lymphocytic Leukemia, as part of our strategy to expand across CLL and NHL and bring this novel treatment option to broader patient populations with unmet needs. For CLL patients in particular, this could represent a fundamental change in the treatment paradigm, with the potential of an emavusertib-BTKi combination to enable time-limited treatment. We look forward to beginning enrollment later this year."
Operational Highlights
NHL/CLL
Presented at the 2025 Annual Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting the poster titled, Analysis of genetic mutation profile and CNS pharmacokinetics in relapsed/refractory primary CNS lymphoma patients responding to novel emavusertib (IRAK4i) and BTKi combination.
Continued to enroll relapsed/refractory Primary Central Nervous System Lymphoma (R/R PCNSL) patients in the Company’s TakeAim Lymphoma study which, as a result of discussions with the EMA and FDA, is now enrolling patients to support registration. Emavusertib has been granted orphan drug designation by both the FDA and EMA in PCNSL.
Adding a proof-of-concept clinical study of emavusertib in combination with a BTKi in 20-30 patients with R/R CLL with the goal of improving upon the current standard of care (BTKi) with its limitations of partial responses and life-long therapy. The combination of emavusertib with a BTKi has the potential to enable patients to achieve complete remission or minimal residual disease (MRD) negativity and time-limited treatment, which would be a paradigm shift in the management of CLL.
Leukemia
Completed enrollment in the TakeAim Leukemia Phase 1/2 study of emavusertib as a monotherapy in patients with R/R Acute Myeloid Leukemia (AML) or R/R Myelodysplastic Syndrome (MDS) and are following several patients still on study treatment.
Engaged clinical trial investigators and key opinion leaders at ASCO (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress on the design of a head-to-head registrational trial vs. gilteritinib in R/R AML based upon encouraging data, Preliminary Safety, Efficacy and Molecular Characterization of Emavusertib (CA-4948) in Relapsed/Refractory Acute Myeloid Leukemia Patients, presented by Dr. Eric Winer at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
Engaged clinical trial investigators and key opinion leaders at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) on the design of a Phase 1/2 study in frontline high-risk MDS (hrMDS) in combination with azacitidine based upon encouraging R/R MDS clinical data at ASH (Free ASH Whitepaper) 2024 in the poster, Preliminary Safety, Efficacy and Molecular Characterization in Higher-Risk Myelodysplastic Syndrome Patients Treated with Single Agent Emavusertib (CA-4948).
Ongoing triplet study evaluating different dosing regimens of emavusertib, venetoclax, and azacitidine in frontline AML, with data expected at the 67th ASH (Free ASH Whitepaper) Annual Meeting in December.
Corporate
Completed a registered direct offering and concurrent private placement extending cash runway to the first quarter of 2026.
Upcoming Presentations and Conferences
Cantor Global Healthcare Conference 2025 – September 2-5, 2025
H.C. Wainwright 27th Annual Global Investment Conference – September 8-10, 2025
Upcoming Milestones
Additional data in R/R PCNSL patients from the TakeAim Lymphoma study is expected later this year.
Second Quarter 2025 Financial Results
For the second quarter of 2025, Curis reported a net loss of $8.6 million or $0.68 per share on both a basic and diluted basis as compared to $11.8 million or $2.03 per share on both a basic and diluted basis, for the same period in 2024. Curis reported a net loss of $19.2 million or $1.82 per share on both a basic and diluted basis, for the six months ended June 30, 2025, as compared to a net loss of $23.7 million or $4.08 per share on both a basic and diluted basis for the same period in 2024.
Revenues for the second quarter of 2025 were $2.7 million as compared to $2.5 million for the same period in 2024. Revenues were $5.1 million for the six months ended June 30, 2025, as compared to $4.6 million for the same period in 2024. Revenues consist of royalty revenues from Genentech/Roche’s sales of Erivedge.
Research and development expenses were $7.5 million for the second quarter of 2025, as compared to $10.3 million for the same period in 2024. The decrease was primarily attributable to lower employee related, research, consulting, and clinical costs. Research and development expenses were $16.0 million for the six months ended June 30, 2025, as compared to $19.9 million for the same period in 2024.
General and administrative expenses were $3.5 million for the second quarter of 2025, as compared to $4.8 million for the same period in 2024. The decrease was primarily attributable to lower employee-related and legal costs. General and administrative expenses were $7.5 million for the six months ended June 30, 2025, as compared to $9.7 million for the same period in 2024.
Other expense was $0.3 million for the second quarter of 2025, as compared to other income of $0.7 million for the same period in 2024. The decrease was primarily attributable to a decrease in interest income and an increase in the expense related to the sale of future royalties. Other expense was $0.8 million for the six months ended June 30, 2025, compared to other income of $1.3 million for the same period in 2024.
Curis’s cash and cash equivalents totaled $10.1 million as of June 30, 2025, and the Company had approximately 10.7 million shares of common stock outstanding. We believe that our existing cash and cash equivalents, together with the net proceeds of $6.0 million from the July 2025 Offerings, 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, August 5, 2025, at 8:30 a.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 8:30 a.m. ET. The webcast can also be accessed on the Curis website at the Events and Presentations section of the Investors page.