Curis Provides First Quarter 2026 Business Update

On May 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 business update and financial results for the quarter ended March 31, 2026.

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Operational Highlights

TakeAim Lymphoma

Emavusertib is currently undergoing testing in combination with the Bruton’s tyrosine kinase inhibitor (BTKi) ibrutinib in the TakeAim Lymphoma Phase 1/2 open-label, single arm expansion trial in patients with Relapsed or Refractory (R/R) Primary CNS Lymphoma (PCNSL) (CA-4948-101, NCT03328078). Patient enrollment in this study is currently ongoing. As a result of discussions with FDA and EMA, the ongoing phase 1/2 study is intended to support filings for accelerated approval of emavusertib in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both FDA and EMA in PCNSL.
TakeAim CLL

Emavusertib is also being tested in the recently initiated open label TakeAim CLL Phase 2 clinical trial of emavusertib in combination with the BTKi zanubrutinib in patients with Chronic Lymphocytic Leukemia (CLL) (CA-4948-203, NCT07271667). The goal of combining emavusertib with a BTKi is to enable a dual blockade of NF-kB, a key driver of disease in CLL and NHL, by inhibiting both the TLR and BCR pathways. The current standard of care is the use of BTK inhibitors, which block the BCR pathway and can deliver high response rates, though typically only partial responses. Previous clinical studies have shown that adding emavusertib, which blocks the TLR pathway, to a BTKi regimen can enable patients with NHL to achieve deeper responses, including complete remission or undetectable minimal residual disease (MRD) and the potential for time-limited treatment, outcomes which represent the potential for a paradigm shift in the management of CLL.
Solid Tumors

Dr. Patrick Grierson, Siteman Cancer Center, Washington University in St Louis, presented a poster with initial clinical data in gastric and esophageal cancer at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2026. In this study, patients are treated with emavusertib in combination with FOLFOX and anti-PD1 +/- trastuzumab as first-line therapy for metastatic or unresectable gastroesophageal cancers. The poster titled A phase I trial of emavusertib (CA-4948) in combination with FOLFOX/ PD-1 inhibitor +/- trastuzumab as first-line treatment for untreated unresectable gastric and esophageal cancer showed results for 16 evaluable patients demonstrating a manageable toxicity profile and encouraging preliminary results.
Dr. Patrick Grierson, Siteman Cancer Center, Washington University in St Louis will have an abstract titled A phase I trial of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC) available online at View Source on May 21, 2026 at 5:00 PM EDT.
Upcoming Milestones

Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL combination study with zanubrutinib by mid-2026, with data expected in December 2026.
Also, the Company expects updated emavusertib clinical data from the TakeAim Lymphoma combination study with ibrutinib in patients with R/R PCNSL in the first half of 2027.
Corporate

On January 9, 2026, the Company announced the closing of a private placement (the "January 2026 PIPE Financing") with gross proceeds of up to $80.8 million, including initial gross proceeds of approximately $20.2 million with three series of warrants (A, B, and C) which can be exercised for up to $20.2 million each according to the terms and conditions of the financing agreement. All three series of warrants are exercisable at $0.75 per share, subject to conditions defined in the financing agreement with respect to the Series B warrants, and have the following termination conditions:

Series A warrants terminate on January 8, 2031;
Series B warrants terminate 30 days after the Company announces dosing of the fifth patient in the Phase 2 clinical trial in CLL, subject to conditions defined in the financing agreement; and
Series C warrants terminate on July 8, 2027.
First Quarter 2026 Financial Results

For the quarter ended March 31, 2026, Curis reported a net loss of $24.2 million, or $1.25 per share on both a basic and diluted basis, as compared to a net loss of $10.6 million, or $1.25 per share on both a basic and diluted basis in 2025.

There were no revenues for the quarter ended March 31, 2026 due to the sale of Erivedge royalties to Oberland in the fourth quarter of 2025. Revenues, net were $2.4 million for the quarter ended March 31, 2025, comprising royalty revenues from Genentech and Roche’s net sales of Erivedge.

Research and development expenses were $6.4 million and $8.5 million for the quarters ended March 31, 2026 and 2025, respectively. The decrease was primarily attributable to lower employee related and manufacturing costs.

General and administrative expenses were $5.1 million and $4.0 million for the quarters ended March 31, 2026 and 2025, respectively. The increase was primarily attributable to expenses associated with the January 2026 PIPE Financing, partially offset by lower employee related costs.

Other expense, net was $12.7 million and $0.5 million for the quarters ended March 31, 2026 and 2025, respectively. The increase was attributable to the change in fair value of the warrant liability associated with the January 2026 PIPE Financing, partially offset by no expense related to the sale of future royalties in 2026.

As of March 31, 2026, Curis’s cash and cash equivalents totaled $15.0 million, and the Company had approximately 40.0 million shares of common stock outstanding.

Cash Runway Guidance

Curis believes its cash and cash equivalents as of March 31, 2026 of $15.0 million, together with anticipated gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE Financing Series B Warrants upon the public announcement of dosing the 5th CLL patient in our TakeAim CLL study expected later this year, should enable the Company’s planned operations into the second half of 2027.

Conference Call Information

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

To access the live conference call, please dial (800)-836-8184 from the United States or (646)-357-8785 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed here on the Curis website in the Investors section.

(Press release, Curis, MAY 12, 2026, View Source [SID1234665532])