Enrolling Phase 2 DAYBreak CLL-201 bexobrutideg trial designed to support Accelerated Approval in relapsed/refractory chronic lymphocytic leukemia (r/r CLL)
Enabling Phase 3 DAYBreak CLL-306 bexobrutideg confirmatory trial for full approval in r/r CLL
Targeting 2026 IND submission for bexobrutideg in inflammatory and autoimmune indications with a new tablet formulation
Continuing advancement of targeted protein degraders of IRAK4 in Phase 1 and STAT6 in IND-enabling studies under strategic partnerships
Well capitalized with
“Nurix entered 2026 focused on implementing a comprehensive registrational program designed to establish bexobrutideg as a potential best-in-class medicine for patients with chronic lymphocytic leukemia,” said
Program Highlights*
Bexobrutideg
Bexobrutideg is an investigational, orally bioavailable, brain penetrant, highly selective small molecule degrader of BTK for the treatment of relapsed or refractory B-cell malignancies and potentially autoimmune diseases.
- DAYBreak CLL-201
Enrollment is ongoing in the DAYBreak CLL-201 pivotal Phase 2 single-arm study (NCT07221500) in patients with r/r CLL, which is designed to support a potential Accelerated Approval submission. The study is enrolling patients whose disease has progressed following treatment with a cBTKi, a BCL-2i, and an ncBTKi inhibitor, representing a population with significant unmet medical need. More information on the Phase 2 trial is available at www.clinicaltrials.gov.
- DAYBreak CLL-306
Nurix plans to initiate a global randomized confirmatory Phase 3 trial by midyear 2026 to support full approval. The Phase 3 study will compare once daily bexobrutideg monotherapy to the most recently approved non-covalent inhibitor, pirtobrutinib, in patients with r/r CLL whose disease has progressed after prior BTK inhibitor therapy.
- NX-5948-301
Nurix continues to enroll select cohorts in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B cell malignancies. The Phase 1b study includes cohorts testing the safety and efficacy of the 600 mg dose of bexobrutideg in earlier lines of therapy in CLL patients. Updated data from this study are anticipated to be presented at upcoming medical meetings throughout 2026. More information on the ongoing Phase 1a/1b trial of bexobrutideg is available at www.clinicaltrials.gov.
- Healthy volunteer SAD/MAD study
Nurix is conducting a Phase 1 single ascending and multiple ascending dose (SAD/MAD) study (NCT06717269) to evaluate pharmacokinetics (PK), pharmacodynamics (PD), and safety of a new tablet formulation of bexobrutideg. This study is intended to support an IND filing and enable expansion into immunology and inflammation indications in 2026. More information on the Phase 1 SAD/MAD trial of bexobrutideg is available at www.clinicaltrials.gov.
Zelebrudomide
Zelebrudomide is an orally bioavailable degrader of BTK and the cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (
NX-1607
NX-1607 is an investigational oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types and lymphomas. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial (NCT05107674) in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov.
Strategic collaborations with Gilead, Sanofi and Pfizer
Sanofi continues to advance the STAT6 degrader, NX-3911, in IND-enabling studies. Nurix retains the right to opt-in after clinical proof of concept to a 50/50
*Expected timing of events throughout this press release is based on calendar year quarters.
Fiscal First Quarter 2026 Financial Results
Revenue for the three months ended
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Net loss for the three months ended
Cash, cash equivalents and marketable securities were
About
Forward-Looking Statements
This press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurix’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding: Nurix’s future financial or business performance; Nurix’s future plans, prospects and strategies; Nurix’s plans and expectations with respect to its current and prospective drug candidates; Nurix’s plans and expectations with respect to the clinical trials for its drug candidates; the tolerability, safety profile, therapeutic potential and other advantages of Nurix’s drug candidates; the planned timing and conduct of Nurix’s clinical trials; the planned timing for the provision of updates and findings from Nurix’s preclinical studies and clinical trials; and the potential benefits of and Nurix’s expectations with respect to its strategic collaborations. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions regarding the future of Nurix’s business, its future plans and strategies, its development plans, its preclinical and clinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix’s actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) whether Nurix will be able to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) uncertainties related to the timing and results of preclinical studies and clinical trials; (iii) whether Nurix will be able to fund development activities and achieve development goals; (iv) uncertainties related to the timing and receipt of payments from Nurix’s collaboration partners, including milestone payments and royalties on future product sales; (v) the impact of global business, political and macroeconomic conditions, cybersecurity events, instability in the banking system, and global events, including regional and military conflicts around the world, on Nurix’s business, clinical trials, financial condition, liquidity and results of operations; (vi) whether Nurix will be able to protect intellectual property and (vii) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the fiscal quarter ended
Contacts:
Investors
kfortner@nurixtx.com
swheeler@wheelhouselsa.com
Media
Aljanae Reynolds
areynolds@wheelhouselsa.com
Kfortner@nurixtx.com
--MORE--
Condensed Statements of Operations (in thousands, except share and per share amounts) (unaudited) | ||||||
| Three Months Ended | ||||||
| 2026 | 2025 | |||||
| Revenue: | ||||||
| Collaboration revenue | $ | 6,252 | $ | 18,453 | ||
| Total revenue | 6,252 | 18,453 | ||||
| Operating expenses: | ||||||
| Research and development | 84,137 | 69,663 | ||||
| General and administrative | 14,610 | 11,654 | ||||
| Total operating expenses | 98,747 | 81,317 | ||||
| Loss from operations | (92,495) | (62,864) | ||||
| Interest and other income, net | 5,321 | 6,513 | ||||
| Net loss | $ | (87,174) | $ | (56,351) | ||
| Net loss per share, basic and diluted | $ | (0.79) | $ | (0.67) | ||
| Weighted-average number of shares outstanding, basic and diluted | 110,071,668 | 83,560,795 | ||||
Condensed Balance Sheets (in thousands) (unaudited) | ||||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 71,195 | $ | 246,960 | ||||
| Marketable securities | 469,537 | 345,981 | ||||||
| Prepaid expenses and other current assets | 13,662 | 13,878 | ||||||
| Total current assets | 554,394 | 606,819 | ||||||
| Operating lease right-of-use assets | 51,657 | 50,517 | ||||||
| Property and equipment, net | 21,697 | 22,490 | ||||||
| Restricted cash | 968 | 968 | ||||||
| Other assets | 7,414 | 7,341 | ||||||
| Total assets | $ | 636,130 | $ | 688,135 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 10,293 | $ | 11,215 | ||||
| Accrued expenses and other current liabilities | 59,950 | 54,852 | ||||||
| Operating lease liabilities, current | 3,202 | 2,824 | ||||||
| Deferred revenue, current | 18,754 | 17,580 | ||||||
| Total current liabilities | 92,199 | 86,471 | ||||||
| Operating lease liabilities, net of current portion | 55,453 | 52,906 | ||||||
| Deferred revenue, net of current portion | 7,585 | 10,011 | ||||||
| Total liabilities | 155,237 | 149,388 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock | 103 | 102 | ||||||
| Additional paid-in-capital | 1,571,134 | 1,541,766 | ||||||
| Accumulated other comprehensive income | 56 | 105 | ||||||
| Accumulated deficit | (1,090,400 | ) | (1,003,226 | ) | ||||
| Total stockholders’ equity | 480,893 | 538,747 | ||||||
| Total liabilities and stockholders’ equity | $ | 636,130 | $ | 688,135 | ||||
Source: 