Collaboration partner, Gilead Sciences, to begin Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy volunteers in Q2 2025 GS-6791/NX-0479 has potential clinical applications across multiple blockbuster markets in inflammation, in both rheumatology and dermatology, including rheumatoid arthritis and atopic dermatitis Nurix to receive a $5 million milestone payment from Gilead for FDA clearance of the IND, bringing the total amount received under the 2019 collaboration agre ...

Core Insights - Nurix Therapeutics, Inc. (NRIX) reported a quarterly loss of $0.67 per share, better than the Zacks Consensus Estimate of a loss of $0.72, and an improvement from a loss of $0.76 per share a year ago, resulting in an earnings surprise of 6.94% [1] - The company generated revenues of $18.45 million for the quarter ended February 2025, exceeding the Zacks Consensus Estimate by 26.41%, compared to $16.59 million in the same quarter last year [2] - Nurix Therapeutics shares have declined approximately 48.4% year-to-date, contrasting with the S&P 500's decline of 13.9% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.74 on revenues of $14.87 million, and for the current fiscal year, it is -$3.06 on revenues of $61.09 million [7] - The estimate revisions trend for Nurix Therapeutics is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Nurix Therapeutics belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]

Clinical Development - The company is focused on targeted protein degradation for cancer and autoimmune diseases, leveraging its DEL-AI discovery engine [127]. - The clinical pipeline includes bexobrutideg (NX-5948) and NX-2127, both in Phase 1a/1b studies for B-cell malignancies, with a Phase 2 trial for bexobrutideg expected to start in 2025 [129][130]. - Bexobrutideg received Fast Track designation from the FDA for chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM) after at least two lines of therapy [129]. - NX-1607, an orally bioavailable inhibitor of CBL-B, is currently in Phase 1a/1b studies for oncology indications [131][132]. - The company aims to address significant unmet needs in diseases such as cancer and autoimmunity through its innovative drug discovery efforts [133]. Financial Performance - Total revenue for the three months ended February 28, 2025, was $18,453,000, an increase of $1,868,000 (11.3%) compared to $16,585,000 for the same period in 2024 [175]. - Collaboration revenue increased by $1,868,000 (11.3%) to $18,453,000, primarily driven by a $4,464,000 increase from Sanofi, offset by a $2,910,000 decrease from Gilead [176]. - The company has incurred net losses of $56.4 million and $41.5 million for the three months ended February 28, 2025, and February 29, 2024, respectively [155]. - Net loss for the three months ended February 28, 2025, was $56,351,000, an increase of $14,833,000 (35.7%) compared to a net loss of $41,518,000 in the prior year [175]. - Cash used in operating activities was $61,087,000, compared to $41,951,000 in the same period last year, reflecting increased operational costs [193]. Collaboration and Financing - The company has received $440 million in non-dilutive financing from collaborations with Gilead, Sanofi, and Seagen, with potential future payments of up to $7.1 billion [134]. - Sanofi paid $22 million to expand the number of targets in their collaboration agreement from three to five [141]. - The Gilead Agreement includes a $15 million payment triggered by the extension of the research term for certain drug targets [135]. - The company is eligible for approximately $1.8 billion in total additional payments based on future milestones and successful completion of development [138]. - Pfizer Agreement included an upfront payment of $60.0 million and potential contingent payments of up to $3.4 billion based on milestones [151]. Expenses and Cash Flow - Total research and development expenses for the three months ended February 28, 2025, were $69.7 million, an increase of $19.7 million from $50.0 million in the same period in 2024 [168]. - Research and development expenses rose by $19,658,000 (39.3%) to $69,663,000, attributed to increased clinical and contract manufacturing costs [177]. - General and administrative expenses decreased slightly by $145,000 (1.2%) to $11,654,000, due to lower legal fees [178]. - The accumulated deficit as of February 28, 2025, was $795.1 million, reflecting significant losses primarily from research and development activities [155]. - Cash, cash equivalents, and marketable securities totaled $549.7 million as of February 28, 2025, expected to fund operations for at least the next 12 months [158]. Future Outlook - The company does not expect to generate product revenue until successful development and regulatory approval of drug candidates, which may take several years [156]. - The company is focused on future commercialization activities, including product manufacturing and marketing for drug candidates pending approval [195]. - General and administrative expenses are expected to increase as the company continues to operate as a public entity and improve its infrastructure [169].

Revenue Performance - Revenue for Q1 2025 was $18.5 million, up from $16.6 million in Q1 2024, primarily due to increased collaboration revenue with Sanofi[12] - Total revenue for the three months ended February 28, 2025, was $18,453,000, an increase of 11.2% compared to $16,585,000 for the same period in 2024[20] - Collaboration revenue for the period was $18,453,000, consistent with total revenue, indicating no additional revenue streams reported[20] Research and Development - Nurix achieved $7 million in research milestones from Sanofi during Q1 2025 and received a $15 million license extension payment post-quarter[12] - Research and development expenses for Q1 2025 were $69.7 million, compared to $50 million in Q1 2024, driven by clinical and manufacturing costs[13] - Research and development expenses rose significantly to $69,663,000, up from $50,005,000, reflecting a 39.4% increase year-over-year[20] - The company is advancing multiple clinical trials for its drug candidates, including NX-2127 and NX-1607, with updates expected in 2025[6][8] - Nurix plans to initiate pivotal trials for bexobrutideg in chronic lymphocytic leukemia (CLL) in 2025[3] Financial Performance - Net loss for Q1 2025 was $56.4 million, or $0.67 per share, compared to a net loss of $41.5 million, or $0.76 per share, in Q1 2024[14] - Net loss for the period was $56,351,000, compared to a net loss of $41,518,000 in the prior year, indicating a deterioration in financial performance[20] - Net loss per share, basic and diluted, improved slightly to $(0.67) from $(0.76) year-over-year[20] - Accumulated deficit increased to $(795,120,000) from $(738,769,000), indicating a worsening financial position[22] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $549.7 million as of February 28, 2025, down from $609.6 million as of November 30, 2024[15] - Total current assets decreased to $563,703,000 from $619,387,000, a decline of 9.0%[22] - Cash and cash equivalents decreased to $75,916,000 from $109,997,000, representing a decline of 30.9%[22] - Total stockholders' equity decreased to $480,917,000 from $526,993,000, a decline of 8.7%[22] Collaborations and Leadership - Nurix continues to collaborate with Gilead, Sanofi, and Pfizer, expecting to achieve substantial research collaboration milestones[11] - Nurix appointed Roy D. Baynes to its board and John Northcott as chief commercial officer to enhance leadership[5] Regulatory Developments - Bexobrutideg received U.S. FDA Orphan Drug Designation for the treatment of Waldenström macroglobulinemia, providing benefits such as tax credits and market exclusivity[4]

Core Insights - Nurix Therapeutics has achieved significant milestones in its clinical development, particularly with the drug bexobrutideg, which has received FDA Orphan Drug Designation for Waldenström macroglobulinemia [4][10] - The company reported a revenue increase to $18.5 million for the fiscal quarter ended February 28, 2025, compared to $16.6 million in the same period the previous year, driven by collaboration with Sanofi [10][11] - Nurix has strengthened its leadership team with key appointments, including Roy D. Baynes to the Board and John Northcott as chief commercial officer, to support its clinical programs [4][5] Company Developments - Bexobrutideg, previously known as NX-5948, is an oral, brain-penetrant BTK degrader, with pivotal trials expected to start in 2025 for chronic lymphocytic leukemia [3][5] - The company has a robust pipeline, including ongoing trials for NX-2127 and NX-1607, targeting various B-cell malignancies and solid tumors, respectively [6][7] - Nurix's cash and marketable securities totaled $549.7 million as of February 28, 2025, indicating strong financial health to support ongoing and future clinical trials [14][19] Financial Performance - Research and development expenses increased to $69.7 million for the three months ended February 28, 2025, compared to $50.0 million for the same period in 2024, reflecting accelerated clinical activities [11][12] - The net loss for the quarter was $56.4 million, or $0.67 per share, compared to a net loss of $41.5 million, or $0.76 per share, in the prior year [13][18] - The company achieved $7 million in research milestones from its collaboration with Sanofi and received a $15 million license extension payment post-quarter end [10][14]

Core Viewpoint - Nurix Therapeutics (NRIX) shares increased by 8.7% following the announcement of an exclusive licensing agreement with Sanofi (SNY) for a new program targeting a previously untreatable transcription factor related to autoimmune diseases [1] Group 1: Collaboration Details - The collaboration between Nurix and Sanofi, established in 2019, focuses on developing targeted protein degradation therapies using Nurix's DEL-AI discovery platform [2][3] - Sanofi expanded the number of targets from three to five in 2021, indicating a strengthening partnership [2] Group 2: Financial Aspects - Nurix received a $15 million license extension fee from Sanofi and is eligible for up to $465 million in potential milestone payments per licensed program, along with royalties on future sales [9] - Under the revised agreement, Nurix can co-develop and co-promote up to two products in the U.S. after demonstrating clinical proof of concept, sharing profits and losses equally with Sanofi for these programs [7][8] Group 3: Market Performance - Year to date, NRIX stock has decreased by 39.6%, contrasting with the industry’s growth of 1.2% [3] - The stock is experiencing further gains in pre-market trading following the announcement [1]

Core Viewpoint - Wall Street anticipates a year-over-year increase in earnings for Nurix Therapeutics, Inc. despite lower revenues, with actual results being crucial for stock price movement [1][2]. Earnings Expectations - The upcoming earnings report is expected to show a quarterly loss of $0.74 per share, reflecting a year-over-year change of +2.6%, while revenues are projected to be $13.17 million, down 20.6% from the previous year [3]. Estimate Revisions - The consensus EPS estimate has been revised 3.94% lower in the last 30 days, indicating a reassessment by analysts regarding the company's earnings prospects [4][10]. Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that the Most Accurate Estimate is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -20.47%, which indicates a bearish outlook [10][11]. Historical Performance - Nurix Therapeutics has only beaten consensus EPS estimates once in the last four quarters, with a recent surprise of -11.94% when it reported a loss of $0.75 per share against an expected loss of $0.67 [12][13]. Conclusion - The combination of a negative Earnings ESP and a Zacks Rank of 3 makes it challenging to predict a positive earnings surprise for Nurix Therapeutics, suggesting that the stock may not be a compelling candidate for an earnings beat [11][16].

Core Insights - Nurix Therapeutics has announced an exclusive licensing agreement with Sanofi for a previously undruggable transcription factor targeting autoimmune diseases, which is a central regulator of inflammation [1][2] - The collaboration has generated a total of $105 million in payments to Nurix, with the potential for an additional $465 million in development, regulatory, and commercial milestones, along with future royalties [1][2] - Nurix's DEL-AI drug discovery platform has successfully identified novel agents for this target, enhancing the drug discovery pipeline for autoimmune diseases [2] Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on targeted protein degradation medicines, aiming to improve treatment options for cancer and inflammatory diseases [3][4] - The company's pipeline includes degraders of Bruton's tyrosine kinase (BTK) and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), as well as multiple preclinical programs [3][4] - Nurix has received a total of $460 million from various partners, including the $105 million from the Sanofi collaboration, which is crucial for expanding its drug discovery pipeline [2][3]

Core Insights - Nurix Therapeutics, Inc. is set to present preclinical data from its DEL-AI platform and various degrader programs at the AACR 2025 Annual Meeting, highlighting its focus on targeted protein degradation medicines [1][8] Presentation Details - The oral presentation titled "DEL-AI: Proteome-wide in silico screening of multi-billion compound libraries using machine learning foundation models" will be presented by Paul Novick, Ph.D. on April 28, 2025 [2] - Another oral presentation titled "Identification of selective, orally bioavailable Aurora A degraders for treatment of pediatric and adult cancers" will be presented by Ryan Rountree, Ph.D. on April 29, 2025 [2] - The poster presentation titled "NRX-0305: a pan-mutant BRAF degrader with broad preclinical efficacy, brain penetrance, and synergistic potential with MEKi across class 1/2/3 BRAF-mutant cancers" will be presented by Alexandra 'Sasha' Borodovsky, Ph.D. on April 28, 2025 [3] - The poster presentation titled "NX-5948 is a CNS-penetrant catalytic Bruton's tyrosine kinase (BTK) degrader that breaks established design rules for CNS drugs" will be presented by Wylie Palmer, Ph.D. on April 30, 2025 [3] About DEL-AI - DEL-AI is Nurix's proprietary discovery platform that utilizes advanced machine learning for drug discovery, enabling rapid generation of degraders and degrader antibody conjugates (DACs) [4] - The platform leverages hundreds of billions of DEL compound binding signatures from thousands of affinity screens, allowing for the identification of binders for various pharmaceutical targets [4] About Bexobrutideg (NX-5948) - Bexobrutideg is an investigational, orally bioavailable, brain-penetrant small molecule degrader of BTK, currently in a Phase 1 clinical trial for patients with relapsed or refractory B cell malignancies [5] About NRX-0305 - NRX-0305 is a selective, orally bioavailable mutant-specific BRAF degrader showing potent anti-tumor activity in various preclinical models, including those with CNS disease and treatment resistance [6][7] About Aurora A Kinase - Aurora A kinase (AURKA) is frequently overexpressed in various cancers, and Nurix has developed bifunctional targeted protein degraders to address the limitations of traditional inhibitors [7] Company Overview - Nurix Therapeutics focuses on the discovery, development, and commercialization of targeted protein degradation medicines, aiming to improve treatment options for cancer and inflammatory diseases [8] - The company has a clinical-stage pipeline that includes degraders of BTK and inhibitors of CBL-B, along with multiple preclinical programs in collaboration with major pharmaceutical companies [8]

Core Insights - The FDA has granted Orphan Drug Designation to bexobrutideg (NX-5948) for the treatment of Waldenström macroglobulinemia, highlighting its potential as a new therapeutic option for patients with this rare disease [1][3][2] - Bexobrutideg is a first-in-class Bruton's tyrosine kinase (BTK) degrader, which is currently undergoing Phase 1a/b clinical trials for relapsed or refractory B-cell malignancies [1][5] - The designation provides benefits such as tax credits for clinical testing, waiver of FDA application fees, and seven years of market exclusivity upon approval [2] Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on targeted protein degradation medicines, aiming to improve treatment options for cancer and inflammatory diseases [8] - The company is advancing multiple first-in-class or best-in-class degraders and has a partnered drug discovery pipeline with collaborations involving Gilead Sciences, Sanofi, and Pfizer [8] - Nurix's innovative approach includes a fully AI-integrated discovery engine and expertise in ligase, positioning the company to lead in the development of degrader-based treatments [8] Product Details - Bexobrutideg is an investigational, orally bioavailable, brain-penetrant small molecule that has shown early promise in safety and efficacy for patients with Waldenström macroglobulinemia [5][1] - The ongoing Phase 1b expansion cohort continues to enroll patients, with additional clinical data expected to be shared in 2025 [5] - The unique suffix "deg" in the drug's nonproprietary name reflects its novel mechanism of action, differentiating it from traditional inhibitors [3][4] Disease Context - Waldenström macroglobulinemia is a rare type of non-Hodgkin's lymphoma with an incidence of approximately 1,200 to 1,900 cases annually in the U.S., affecting around 12,000 to 19,000 patients currently [7][6] - The disease is characterized by the production of monoclonal IgM, leading to various health complications, and there are currently no approved therapies for patients after BTK inhibitor treatment [7][6]