On July 9, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported financial results for the fiscal quarter ended May 31, 2025, and highlighted significant progress across its clinical programs and strategic collaborations (Press release, Nurix Therapeutics, JUL 9, 2025, View Source [SID1234654310]).
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"During our second quarter, Nurix delivered important collaboration milestones, resulting in Sanofi’s extension of its license for our STAT6 program and FDA clearance of the IND for IRAK4 degrader GS-6791/NX-0479 in collaboration with Gilead," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We are now entering a transformative period as we advance bexobrutideg into pivotal studies in CLL and progress our efforts to bring degrader-based therapies to patients with autoimmune diseases and inflammation."
Recent Business Highlights
Data presented at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML-18):
At EHA (Free EHA Whitepaper)2025 and ICML-18 in June 2025, Nurix presented updated Phase 1 clinical data for bexobrutideg (NX-5948), its investigational oral, brain-penetrant degrader of Bruton’s tyrosine kinase (BTK). The data demonstrated a robust objective response rate (ORR) of 80.9% across all doses in patients with relapsed or refractory CLL, including a complete response (CR) in a high-risk patient. The responses were durable, deepened over time, and were accompanied by a favorable safety profile, with no atrial fibrillation, systemic fungal infections, or dose-limiting toxicities observed. These results support the advancement of bexobrutideg to pivotal studies in CLL and underscore its potential to address significant unmet needs in B-cell malignancies.
Sanofi extended its license for Nurix’s STAT6 program, including STAT6 development candidate NX-3911: In June 2025, Nurix announced that Sanofi exercised its option to extend its license for Nurix’s STAT6 program, including the STAT6 degrader development candidate NX-3911, triggering a $15 million payment and bringing the total received by Nurix under this collaboration to $127 million. Nurix remains eligible for an additional $465 million in development, regulatory, and commercial milestones, plus future royalties and retains the option to co-develop and co-promote the program in the United States. NX-3911 is an oral, highly selective STAT6 degrader. STAT6 is a key transcription factor within the IL-4/IL-13 signaling pathways that drive inflammation in allergic and type 2 inflammatory conditions. Targeting STAT6 for degradation represents a promising therapeutic approach, supported by extensive insights from genetic studies and clinical validation of upstream biologics (IL-4/IL-13 inhibitors) and Janus kinase (JAK) inhibitors. Unlike JAK inhibition, which can impact multiple cytokine pathways and is associated with safety concerns, STAT6 degradation offers a more precise mechanism to modulate inflammation.
FDA clearance of IND application for GS-6791/NX-0479: In April 2025, Nurix announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for GS-6791 (previously NX-0479), a novel, first-in-class oral degrader of IRAK4 being developed in collaboration with Gilead Sciences. GS-6791 is designed to selectively degrade IRAK4, a key signaling protein that drives inflammation in autoimmune and inflammatory diseases. The clearance of this IND represents an important milestone in Nurix’s partnership with Gilead and paved the way for the initiation of first-in-human clinical trials.
Data presented at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting:
In April 2025, Nurix presented positive preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting highlighting its portfolio of orally available, brain-penetrant degraders targeting BTK, pan-mutant BRAF, and Aurora A kinase, key drivers of oncogenic signaling and tumor growth in cancers with central nervous system (CNS) involvement. Bexobrutideg, Nurix’s lead BTK degrader, demonstrated exceptional catalytic efficiency, with a single molecule degrading approximately 10,000 BTK copies per hour, supporting its potential to deliver deep, durable responses at low doses. Nurix’s BRAF degrader showed broad preclinical activity across all three classes of BRAF mutations, including those resistant to approved therapies, while Nurix’s Aurora A degrader demonstrated significant anti-tumor activity in models of pediatric and adult cancers.
At the AACR (Free AACR Whitepaper) Annual Meeting, Nurix also presented data highlighting the transformative potential of its DEL-AI platform, which leverages a first-in-class DEL Foundation Model trained on proprietary DNA-encoded library (DEL) data to enable rapid in silico identification of novel binders for a broad range of therapeutically relevant proteins, including targets previously considered undruggable. This innovative machine learning platform has the potential to significantly accelerate the discovery of degrader-based medicines and other small molecule therapeutics for Nurix’s internal pipeline and discovery collaborations.
European Medicines Agency (EMA) granted Orphan Drug Designation (ODD) to bexobrutideg for the treatment of lymphoplasmacytic lymphoma: In July 2025, Nurix announced that the EMA granted ODD to bexobrutideg for the treatment of lymphoplasmacytic lymphoma, of which Waldenström macroglobulinemia is the most common subtype. The EMA’s Orphan Drug Designation program grants orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 5 in 10,000 people in the European Union. This designation provides several incentives to encourage the development of treatments for rare conditions, including 10 years of market exclusivity in the EU upon approval, access to protocol assistance, eligibility for centralized marketing authorization, and significant reductions in regulatory fees.
Upcoming Program Highlights*
Bexobrutideg (NX-5948): Building on the recent positive data in CLL and WM, Nurix anticipates providing additional clinical updates for bexobrutideg and remains on track to initiate pivotal trials for bexobrutideg in CLL in the second half of 2025. To support future development of bexobrutideg in autoimmune and inflammatory diseases, Nurix has expanded a new Phase 1b cohort for patients with CLL and autoimmune hemolytic anemia and is exploring the filing of a non-malignant hematology IND for autoimmune cytopenias in 2025. More information on the ongoing Phase 1a/1b trial of bexobrutideg is available at www.clinicaltrials.gov (NCT05131022).
Zelebrudomide (NX-2127): Zelebrudomide is an orally bioavailable degrader of BTK and the cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) designed for the treatment of relapsed or refractory B-cell malignancies. Nurix is conducting a Phase 1a/1b clinical trial, including a Phase 1b expansion cohort focused on patients with diffuse large B-cell lymphoma and mantle cell lymphoma. Nurix is enrolling a dose escalation study within the current Phase 1a/1b trial using its new chirally controlled drug product. Future clinical updates are anticipated in the second half of 2025. Additional information on the zelebrudomide clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
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 in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Future clinical updates are anticipated in the second half of 2025. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
Continued pipeline advancement of strategic collaborations with Gilead, Sanofi and Pfizer: Nurix expects to continue to achieve substantial research collaboration milestones throughout the terms of its collaborations with Gilead, Sanofi, and Pfizer.
*Expected timing of events throughout this press release is based on calendar year quarters.
Fiscal Second Quarter 2025 Financial Results
Revenue for the three months ended May 31, 2025, was $44.1 million, compared with $12.1 million for the three months ended May 31, 2024. The increase was primarily due to $30 million of license revenue from the achievement of two Sanofi license extensions and a $5 million clinical milestone achieved under Nurix’s collaboration with Gilead during the three months ended May 31, 2025.
Research and development expenses for the three months ended May 31, 2025, were $78.1 million compared with $48.9 million for the three months ended May 31, 2024. The increase was primarily related to clinical, contract manufacturing and consulting costs as Nurix continued to accelerate the enrollment of patients in the ongoing trial of bexobrutideg and prepare for the initiation of pivotal trials.
General and administrative expenses for the three months ended May 31, 2025, were $14.3 million, compared with $11.7 million for the three months ended May 31, 2024. The increase was primarily due to an increase in compensation and related personnel costs and consulting costs.
Net loss for the three months ended May 31, 2025, was $43.5 million, or ($0.52) per share, compared with $44.5 million, or ($0.71) per share, for the three months ended May 31, 2024.
Cash, cash equivalents and marketable securities was $485.8 million as of May 31, 2025, compared to $609.6 million as of November 30, 2024. Cash, cash equivalents and marketable securities as of May 31, 2025, does not include a $4.0 million milestone earned in the first fiscal quarter of 2025 and received post fiscal quarter end, and a $15.0 million license extension payment received post fiscal quarter end.