Curis Provides Third Quarter 2026 Business Update

On November 12, 2026 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, 2026.

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"We are encouraged by our progress in both the TakeAim CLL study and the TakeAim Lymphoma study," said James Dentzer, Chief Executive Officer of Curis. "The excitement among clinicians and patients reflects the clear unmet need in both CLL and PCNSL, where emavusertib has the potential to change the treatment landscape when combined with approved BTK inhibitors."

Operational Highlights

Curis is currently enrolling patients in 2 ongoing studies, the TakeAim CLL study (CA-4948-203, NCT07271667) and the TakeAim Lymphoma study in PCNSL (CA-4948-101, NCT03328078).

TakeAim CLL

The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL. To be eligible for enrollment, participants must have received zanubrutinib for at least 12 months, achieved a partial response (PR) or partial response with lymphocytosis (PR-L), and have measurable residual disease (MRD+) as determined by the clonoSEQ assay.

To date, 12 patients have been enrolled in the study with initial data expected in December 2026.

TakeAim Lymphoma

The TakeAim Lymphoma Study is a registrational study of emavusertib in combination with ibrutinib in patients with Relapsed/Refractory (R/R) PCNSL (CA-4948-101, NCT03328078). In 2025, Curis presented initial clinical data to the U.S. Food and Drug Administration (FDA) and European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA) and received guidance that the ongoing registrational study could support regulatory applications for accelerated approval in R/R PCNSL.

In July 2026, the Company reported updated data for 7 BTK-naïve and 39 BTKi-experienced patients:

(as of July 1, 2026)

Evaluable*

All

Patients

Patients

BTKi-naïve

100% ORR

86% ORR

(5 of 5)

(6 of 7)

BTKi-experienced

33% ORR

26% ORR

(10 of 30)

(10 of 39)

* evaluable excludes patients who did not complete at least 1 cycle (~1 month) of treatment

About PCNSL and CLL

In PCNSL and CLL, disease is driven by NF-kB dysregulation, which is in turn driven by two biologic pathways: BCR and TLR1. The goal of combining emavusertib with a BTK inhibitor (BTKi) in the TakeAim Lymphoma and TakeAim CLL Studies is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTKi blocks the BCR pathway; emavusertib blocks the TLR pathway.

BTKi is an established standard of care in Relapsed/Refractory (R/R) PCNSL. For BTKi-naïve patients, response rates can be 39%-67%. For salvage-line patients, patients who have been treated with BTKi and progressed, outcomes are generally poor, with many patients proceeding directly to hospice or best supportive care. Initial clinical data have shown that adding emavusertib to a BTKi regimen, directly after a patient progresses on BTKi monotherapy, can enable patients to reverse their disease progression and achieve an objective response.

BTKi is also standard of care in CLL, where outcomes are more favorable than in PCNSL. In the registrational study for the BTKi zanubrutinib in CLL, 93% of patients were able to achieve an objective response, though only 7% achieved complete response2. More recent clinical studies have shown that adding emavusertib to a BTKi regimen, blocking both the TLR and BCR pathways, can enable patients with NHL to achieve deeper responses, including complete responses or undetectable minimal residual disease (MRD).

Corporate

Completed a public offering in August 2026 and a private placement in October 2026 extending cash runway into 2027.

Third Quarter 2026 Financial Results

For the third quarter of 2026, Curis reported a net loss of $8.1 million or $1.94 per share on both a basic and diluted basis as compared to $7.7 million or $9.86 per share on both a basic and diluted basis, for the same period in 2025. Curis reported a net loss of $40.9 million or $16.77 per share on both a basic and diluted basis, for the nine months ended September 30, 2026, as compared to a net loss of $26.9 million or $43.82 per share on both a basic and diluted basis for the same period in 2025.

There was no revenue reported for the quarter or the year ended September 30, 2026 due to the sale of Erivedge royalties to Oberland in the fourth quarter of 2025. Revenues were $3.2 million and $8.3 million for the quarter and year ended September 30, 2025, respectively.

Research and development expenses were $5.6 million for the third quarter of 2026, as compared to $6.4 million for the same period in 2025. The decrease was primarily attributable to lower employee-related costs, partially offset by an increase in clinical costs. Research and development expenses were $18.8 million for the nine months ended September 30, 2026, as compared to $22.4 million for the same period in 2025.

General and administrative expenses were $3.2 million for the third quarter of 2026, as compared to $3.7 million for the same period in 2025. The decrease was primarily attributable to lower employee-related costs, partially offset by an increase in legal costs. General and administrative expenses were $11.4 million for the nine months ended September 30, 2026, as compared to $11.2 million for the same period in 2025.

Other income was $0.6 million for the third quarter of 2026, as compared to other expense of $0.8 million for the same period in 2025. The increase was primarily attributable to the change in fair value of the warrant liability associated with the January 2026 Private Placement, partially offset by a decrease in the expense related to the sale of future royalties. Other expense was $10.7 million for the nine months ended September 30, 2026, as compared to other expense of $1.6 million for the same period in 2025.

Curis’s cash and cash equivalents totaled $5.0 million as of September 30, 2026, and the Company had approximately 4.1 million shares of common stock outstanding. The Company believes that the $5.0 million of existing cash and cash equivalents as of September 30, 2026, together with the net proceeds of approximately $7.5 million from the October 2026 Private Placement, should enable it to fund our existing operations into the first quarter of 2027.

Conference Call and Webcast Information

Curis management will host a conference call today, November 12, 2026, at 4:30 p.m. ET, to discuss the business update and these financial results.

Participants may join by dialing (800)-836-8184 from the United States or (646)-357-8785 from other locations or a live audio webcast can be accessed here or from the investor section of the Curis website. A replay of the conference call will be available at www.curis.com.

(Press release, Curis, NOV 12, 2026, View Source [SID1234674670])