Nurix Therapeutics(NRIX) - 2025 Q3 - Quarterly Results

Company Overview & Q3 FY2025 Highlights Nurix Therapeutics reports Q3 FY2025 financial results and clinical program advancements, preparing for bexobrutideg pivotal trials and showcasing strong preclinical data for GS-6791 Q3 FY2025 Key Updates Nurix Therapeutics announced Q3 FY2025 financial results, highlighting significant progress in clinical programs and strategic collaborations - Nurix Therapeutics is preparing to initiate pivotal trials for bexobrutideg in relapsed/refractory CLL patients in H2 2025, including a single-arm study for potential accelerated approval and a confirmatory randomized controlled Phase 3 study for full approval[1][3] - Preclinical data for the IRAK4 degrader GS-6791 (NX-0479), in collaboration with Gilead, demonstrated potent pathway inhibition and efficacy in dermatitis models[1][4] - As of August 31, 2025, the company held $428.8 million in cash and marketable securities, indicating a strong capital position[1][13] Recent Business and Clinical Development Highlights Nurix provides updates on bexobrutideg clinical development plans, including pivotal trials for CLL, and preclinical data for the IRAK4 degrader GS-6791 Bexobrutideg Clinical Development Plans Nurix outlined pivotal trial plans for bexobrutideg in relapsed/refractory CLL, including single-arm and randomized Phase 3 studies, with Phase 1a data showing high ORR and good tolerability - Nurix plans to initiate a single-arm study for bexobrutideg in relapsed/refractory CLL patients in H2 2025, aiming for accelerated approval[4] - The company also described the design of a randomized controlled Phase 3 trial comparing bexobrutideg to investigator's choice comparators, including bendamustine and rituximab, idelalisib and rituximab, or pirtobrutinib[4] Bexobrutideg in Relapsed/Refractory CLL Phase 1a data for bexobrutideg in CLL patients showed an 80.9% objective response rate, rapid and durable responses, and good tolerability - Phase 1a data for bexobrutideg, presented at SOHO 2025, showed an objective response rate (ORR) of 80.9% in 47 evaluable patients, including one complete response[4] - Responses were rapid, with a median time to first response of 1.9 months, deepening with continued treatment, and durable activity was observed in high-risk subgroups including TP53, PLCG2, and BTK mutations, and CNS involvement[4] - Bexobrutideg was well-tolerated, with no dose-limiting toxicities and no new onset atrial fibrillation or flutter[4] Bexobrutideg in Waldenström Macroglobulinemia (WM) Phase 1 data for bexobrutideg in WM patients demonstrated an 84.2% objective response rate, rapid and durable responses, and good tolerability - Phase 1 data for bexobrutideg, presented at SOHO 2025, showed an objective response rate (ORR) of 84.2% in 19 evaluable patients, with responses observed in both MYD88 and CXCR4 mutated patients[4] - Responses were rapid, durable, and associated with deep reductions in serum IgM levels[4] - Bexobrutideg was well-tolerated, with a safety profile consistent with previous reports, no dose-limiting toxicities, and no atrial fibrillation[4] GS-6791 (IRAK4 Degrader) Preclinical Data Nurix and Gilead presented preclinical data for GS-6791, a novel oral IRAK4 degrader, showing potent degradation, pathway inhibition, and efficacy in dermatitis models - At EADV 2025, Nurix and Gilead presented preclinical findings for GS-6791, a novel, selective oral IRAK4 degrader[4] - Data showed GS-6791 effectively degraded IRAK4 in immune and epithelial cells, blocking IL-1 and IL-36 signaling pathways associated with autoimmune and inflammatory diseases[4] - In vivo studies demonstrated GS-6791 inhibited cytokine production and improved disease metrics in a mouse dermatitis model[4] Upcoming Program Milestones Nurix outlines future development plans for bexobrutideg, zelebrudomide, NX-1607, and strategic collaboration pipeline advancements Bexobrutideg Future Development Nurix plans to initiate pivotal trials for bexobrutideg in CLL in H2 2025, recruit Phase 1b cohorts for CLL and autoimmune hemolytic anemia, and conduct healthy volunteer studies for a potential 2026 autoimmune IND - Nurix expects to provide additional clinical updates for bexobrutideg and remains on track to initiate pivotal trials for bexobrutideg in CLL in H2 2025[5] - To support future development of bexobrutideg in autoimmune and inflammatory diseases, Nurix is recruiting Phase 1b cohorts for patients with CLL and autoimmune hemolytic anemia[5] - The company is conducting necessary Phase 1 healthy volunteer studies to support a potential autoimmune IND application in 2026[5] Zelebrudomide Development Zelebrudomide, an oral BTK and cereblon new substrate degrader, is in Phase 1a/1b clinical trials for relapsed or refractory B-cell malignancies, with ongoing dose-escalation studies - Zelebrudomide is an orally bioavailable degrader of BTK and cereblon new substrates IKZF1 (Ikaros) and IKZF3 (Aiolos), designed to treat relapsed or refractory B-cell malignancies[6] - 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[6] - The company is enrolling patients in dose-escalation studies using chirally controlled drug product in the current Phase 1a/1b trial[6] NX-1607 Development NX-1607, an oral CBL-B E3 ligase inhibitor, is in Phase 1 trials for immuno-oncology indications, including solid tumors and lymphomas, to fully investigate dosing and regimens - NX-1607 is an oral inhibitor of CBL-B E3 ligase, being developed for immuno-oncology indications, including various solid tumors and lymphomas[7] - Nurix is conducting an ongoing adult Phase 1 trial for NX-1607, which includes a comprehensive investigation of dosing and regimens in the Phase 1a portion[7] Strategic Collaborations Pipeline Advancement Nurix and Sanofi continue IND-enabling studies for STAT6 degrader NX-3911, expecting ongoing research collaboration milestones with Gilead, Sanofi, and Pfizer - Nurix and Sanofi continue to advance IND-enabling studies for the STAT6 degrader NX-3911, with updates expected in the future[8] - Nurix anticipates achieving ongoing significant research collaboration milestones under its agreements with Gilead, Sanofi, and Pfizer[8] Fiscal Third Quarter 2025 Financial Results Nurix Therapeutics reports its financial performance for Q3 FY2025, detailing revenue, operating expenses, net loss, and cash position Revenue Analysis Q3 FY2025 revenue decreased to $7.9 million from $12.6 million in the prior year, primarily due to the conclusion of a Sanofi collaboration, partially offset by increased Pfizer collaboration completion Revenue Overview | Metric | Three Months Ended August 31, 2025 (million USD) | Three Months Ended August 31, 2024 (million USD) | | :--- | :---: | :---: | | Collaboration revenue | 7.9 | 12.6 | | Total Revenue | 7.9 | 12.6 | - Revenue decreased due to the conclusion of a research term with Sanofi[10] - The decrease in revenue was partially offset by a higher percentage of completion for performance obligations under the collaboration with Pfizer[10] Operating Expenses Analysis Total operating expenses for Q3 FY2025 significantly increased to $99.2 million from $67.2 million in the prior year, driven by higher R&D and G&A expenses Operating Expenses Summary | Metric | Three Months Ended August 31, 2025 (million USD) | Three Months Ended August 31, 2024 (million USD) | | :--- | :---: | :---: | | Research and development | 86.1 | 55.5 | | General and administrative | 13.2 | 11.7 | | Total Operating Expenses | 99.3 | 67.2 | Research and Development Expenses R&D expenses increased to $86.1 million, primarily due to higher clinical, contract manufacturing, and consulting costs as Nurix accelerates trial enrollment and prepares for pivotal studies R&D Expenses | Metric | Three Months Ended August 31, 2025 (million USD) | Three Months Ended August 31, 2024 (million USD) | | :--- | :---: | :---: | | Research and development expenses | 86.1 | 55.5 | | Year-over-year growth | 55.1% | | - The increase in R&D expenses was primarily related to clinical, contract manufacturing, and consulting costs as Nurix continues to accelerate patient enrollment in ongoing bexobrutideg trials and prepares for pivotal trial initiation[11] General and Administrative Expenses G&A expenses increased to $13.2 million, mainly due to higher compensation and related personnel costs G&A Expenses | Metric | Three Months Ended August 31, 2025 (million USD) | Three Months Ended August 31, 2024 (million USD) | | :--- | :---: | :---: | | General and administrative expenses | 13.2 | 11.7 | | Year-over-year growth | 12.8% | | - The increase in G&A expenses was primarily due to higher compensation and related personnel costs[12] Net Loss and EPS Net loss for Q3 FY2025 expanded to $86.4 million, or $1.03 per share, compared to a net loss of $49.0 million, or $0.67 per share, in the prior year Net Loss and EPS Summary | Metric | Three Months Ended August 31, 2025 (million USD) | Three Months Ended August 31, 2024 (million USD) | | :--- | :---: | :---: | | Net loss | (86.4) | (49.0) | | Net loss per share | (1.03) | (0.67) | Cash Position Cash, cash equivalents, and marketable securities totaled $428.8 million as of August 31, 2025, down from $609.6 million as of November 30, 2024 Cash, Cash Equivalents, and Marketable Securities | Metric | August 31, 2025 (million USD) | November 30, 2024 (million USD) | | :--- | :---: | :---: | | Cash, cash equivalents, and marketable securities | 428.8 | 609.6 | About Nurix Therapeutics, Inc. Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on targeted protein degradation for cancer and inflammatory diseases, leveraging its AI-integrated discovery engine and E3 ligase expertise Company Profile Nurix Therapeutics is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing targeted protein degradation drugs to improve treatment options for cancer and inflammatory diseases - Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation drugs to improve treatment options for patients with cancer and inflammatory diseases[14] - The company has an internal clinical-stage pipeline, including BTK degraders and CBL-B inhibitors, and strategic collaborations with Gilead, Sanofi, and Pfizer for preclinical and clinical-stage degrader programs[14] - Nurix leverages its fully AI-integrated discovery engine and E3 ligase expertise to translate targeted protein degradation science into clinical advancements, aiming to make degrader therapies a forefront of patient care[14] Financial Statements This section presents Nurix Therapeutics' condensed statements of operations and balance sheets for the specified periods Condensed Statements of Operations This section provides Nurix Therapeutics' condensed statements of operations for the three and nine months ended August 31, 2025, detailing key financial metrics like revenue, operating expenses, net loss, and EPS Condensed Statements of Operations | | Three Months Ended | | Nine Months Ended | | | :--- | :---: | :---: | :---: | :---: | | | August 31, 2025 (thousand USD) | August 31, 2024 (thousand USD) | August 31, 2025 (thousand USD) | August 31, 2024 (thousand USD) | | Revenue: | | | | | | Collaboration revenue | $ 7,894 | $ 12,588 | $ 40,403 | $ 41,265 | | License revenue | — | — | 30,000 | — | | Total revenue | 7,894 | 12,588 | 70,403 | 41,265 | | Operating expenses: | | | | | | Research and development | 86,120 | 55,481 | 233,879 | 154,408 | | General and administrative | 13,159 | 11,718 | 39,095 | 35,227 | | Total operating expenses | 99,279 | 67,199 | 272,974 | 189,635 | | Loss from operations | (91,385) | (54,611) | (202,571) | (148,370) | | Interest and other income, net | 4,964 | 5,737 | 17,095 | 13,612 | | Loss before income taxes | (86,421) | (48,874) | (185,476) | (134,758) | | Provision for income taxes | — | 82 | 760 | 262 | | Net loss | $ (86,421) | $ (48,956) | $ (186,236) | $ (135,020) | | Net loss per share, basic and diluted | $ (1.03) | $ (0.67) | $ (2.22) | $ (2.13) | | Weighted-average number of shares outstanding, basic and diluted | 84,159,336 | 72,779,381 | 83,869,469 | 63,384,174 | Condensed Balance Sheets This section presents Nurix Therapeutics' condensed balance sheets as of August 31, 2025, and November 30, 2024, outlining assets, liabilities, and stockholders' equity Condensed Balance Sheets | | | August 31, 2025 (thousand USD) | | November 30, 2024 (thousand USD) | | :--- | :--- | :---: | :--- | :---: | | Assets | | | | | | Current assets: | | | | | | Cash and cash equivalents | $ | 78,438 | $ | 109,997 | | Marketable securities | | 350,391 | | 499,586 | | Prepaid expenses and other current assets | | 11,774 | | 9,804 | | Total current assets | | 440,603 | | 619,387 | | Operating lease right-of-use assets | | 53,028 | | 28,139 | | Property and equipment, net | | 20,498 | | 17,757 | | Restricted cash | | 968 | | 901 | | Other assets | | 7,375 | | 3,159 | | Total assets | $ | 522,472 | $ | 669,343 | | Liabilities and stockholders' equity | | | | | | Current liabilities: | | | | | | Accounts payable | $ | 8,609 | $ | 11,482 | | Accrued expenses and other current liabilities | | 43,957 | | 37,994 | | Operating lease liabilities, current | | 3,791 | | 8,014 | | Deferred revenue, current | | 25,993 | | 38,364 | | Total current liabilities | | 82,350 | | 95,854 | | Operating lease liabilities, net of current portion | | 52,695 | | 20,289 | | Deferred revenue, net of current portion | | 15,175 | | 26,207 | | Total liabilities | | 150,220 | | 142,350 | | Stockholders' equity: | | | | | | Common stock | | 77 | | 76 | | Additional paid-in-capital | | 1,297,061 | | 1,265,536 | | Accumulated other comprehensive income | | 119 | | 150 | | Accumulated deficit | | (925,005) | | (738,769) | | Total stockholders' equity | | 372,252 | | 526,993 | | Total liabilities and stockholders' equity | $ | 522,472 | $ | 669,343 | Forward-Looking Statements This section contains forward-looking statements regarding future events and expectations, subject to risks and uncertainties that may cause actual results to differ materially Disclaimer This press release contains forward-looking statements subject to risks and uncertainties, and Nurix disclaims any obligation to publicly update them unless required by law - This press release contains forward-looking statements regarding future events and expectations, subject to the Private Securities Litigation Reform Act of 1995[15] - Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and changes in circumstances that may cause actual activities and results to differ from those expressed in any forward-looking statement[15] - Nurix disclaims any obligation to publicly update any forward-looking statements unless required by applicable law[15] Contacts This section provides investor relations and media contact information for Nurix Therapeutics Investor and Media Contacts This section provides investor relations and media contact information for Nurix Therapeutics - Investor Contacts: Kris Fortner, Nurix Therapeutics, Inc., ir@nurixtx.com; Elizabeth Wolffe, Ph.D., Wheelhouse Life Science Advisors, lwolffe@wheelhouselsa.com[16][17] - Media Contact: Aljanae Reynolds, Wheelhouse Life Science Advisors, areynolds@wheelhouselsa.com[17]