Nurix Therapeutics(NRIX)
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Nurix Therapeutics Appoints Drug Development Expert Roy D. Baynes, MB.Bch., M.Med., Ph.D., to Its Board of Directors
Newsfilter· 2025-03-13 20:00
Core Insights - Nurix Therapeutics, Inc. has appointed Dr. Roy D. Baynes to its board of directors, bringing over 22 years of clinical leadership experience in hematology and oncology [1][2] - Dr. Baynes has been a trusted advisor to Nurix since 2023 and is expected to contribute significantly to the company's pipeline development in oncology and autoimmune indications [2] - Nurix focuses on targeted protein degradation medicines, aiming to improve treatment options for cancer and inflammatory diseases [3] Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of targeted protein degradation medicines [3] - The company's pipeline includes degraders of Bruton's tyrosine kinase (BTK) and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), with a focus on potentially first-in-class or best-in-class treatments [3] - Nurix has collaborations with major pharmaceutical companies such as Gilead Sciences, Sanofi, and Pfizer, retaining options for co-development and profit sharing in the U.S. for multiple drug candidates [3]
Nurix Therapeutics Appoints Drug Development Expert Roy D. Baynes, MB.Bch.
GlobeNewswire News Room· 2025-03-13 20:00
SAN FRANCISCO, March 13, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, announced today the appointment of Roy D. Baynes, MB.Bch., M.Med., Ph.D., to its board of directors. Dr. Baynes, who currently serves as executive vice president and chief medical officer of Eikon Therapeutics, has had a distinguished career in hematology and oncology and ov ...
Nurix Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2025-02-14 21:01
SAN FRANCISCO, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (NASDAQ:NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases, today announced that on February 11, 2025, the company granted inducement awards to nine new employees. The grants were made pursuant to Nurix's ...
Nurix Therapeutics to Participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference
Globenewswire· 2025-02-04 12:00
SAN FRANCISCO, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases, today announced that Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix, will participate in a fireside chat at the O ...
Nurix Therapeutics, Inc. (NRIX) Reports Q4 Loss, Lags Revenue Estimates
ZACKS· 2025-01-28 23:11
Nurix Therapeutics, Inc. (NRIX) came out with a quarterly loss of $0.75 per share versus the Zacks Consensus Estimate of a loss of $0.67. This compares to loss of $0.77 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -11.94%. A quarter ago, it was expected that this company would post a loss of $0.67 per share when it actually produced a loss of $0.67, delivering no surprise.Over the last four quarters, the company has surpass ...
Nurix Therapeutics(NRIX) - 2024 Q4 - Annual Report
2025-01-28 21:15
Financial Performance - The company reported a net loss of $193.6 million for the fiscal year ended November 30, 2024, compared to a net loss of $143.9 million for the previous year, with an accumulated deficit of $738.8 million [248]. - The company’s financial condition and results of operations are expected to fluctuate significantly, making it difficult to predict future performance [261]. - The company has cash, cash equivalents, and marketable securities totaling $609.6 million, which is expected to fund operations for at least the next 12 months [254]. Drug Development and Clinical Trials - The company has never generated revenue from product sales and is in the early stages of clinical development for its lead drug candidates NX-5948, NX-2127, and NX-1607, which are expected to take many years to reach commercialization [251]. - The company anticipates significant increases in operating expenses and capital expenditures as it conducts Phase 1 clinical trials and expands its DEL-AI platform [253]. - The company expects to incur significant commercialization expenses if any drug candidates receive marketing approval, which may impact profitability [252]. - The company is in early clinical development stages for drug candidates NX-5948 and NX-2127, with limited safety data available in humans [269]. - The company anticipates initiating a Phase 2 clinical trial for NX-5948 in 2025, following ongoing Phase 1 trials [282]. - Clinical trials may produce negative or inconclusive results, necessitating additional trials or preclinical studies [272]. - Patient enrollment for clinical trials may be challenging due to competition and the small size of relevant patient populations [282]. - The company faces significant challenges in enrolling sufficient patients for clinical trials, which could lead to delays and increased development costs [283]. Regulatory Environment - The regulatory approval process for novel drug candidates is expected to be lengthy and costly, with no current approvals for targeted protein degradation therapies [270]. - The FDA's discretion in the approval process means that even promising clinical trial data may not guarantee marketing approval [377]. - Regulatory approval processes vary significantly across countries, and failure to obtain timely approvals could limit revenue generation from product sales [392]. - The company must comply with ongoing regulatory requirements post-approval, which could limit marketing and revenue generation capabilities [395]. - The FDA may require additional studies or trials prior to granting approval, which could delay commercialization and increase development costs [387]. Collaborations and Partnerships - The company is reliant on collaborations with Gilead, Sanofi, and Pfizer for potential future milestone payments, but currently lacks committed external funding sources [257]. - Collaborations with third parties, such as Gilead and Sanofi, are crucial for the development of drug candidates, but the success of these collaborations is uncertain [295]. - Collaborations may require the company to incur non-recurring charges and increase expenditures, impacting financial stability [297]. - Gilead and Sanofi have rights to select up to five targets each for exclusive development, which may impact the company's ability to pursue its own targets [296]. Intellectual Property Risks - Patent protection is critical for the company's drug candidates, and failure to secure it could impair competitive advantage [327]. - The company may face significant uncertainty regarding the patentability and enforceability of its drug candidates due to potential third-party intellectual property rights [332]. - The risk of patent infringement claims increases as the biotechnology and pharmaceutical industries expand and more patents are issued [346]. - The company may face significant costs and resource diversion due to potential litigation over intellectual property rights [345]. - Patent applications related to novel protein degradation therapies are competitive, with many companies actively filing applications, which may affect the company's future product development [348]. Market and Competitive Landscape - The competitive landscape includes numerous biotechnology companies with greater financial resources and expertise, posing a risk to the company's market position [291]. - The company’s estimated market opportunities for drug candidates are subject to significant uncertainties, which could limit future growth if overestimated [293]. - Changes in patent laws could diminish the value of patents, impacting the company's ability to protect its drug candidates [335]. Operational Challenges - The company lacks a sales and marketing infrastructure, which may hinder the commercialization of its drug candidates if approved [316]. - Establishing a specialized sales and marketing organization in the U.S. is expected, but it involves significant costs and risks [317]. - The company does not own manufacturing facilities and relies on third-party contract manufacturing organizations (CMOs), increasing risks related to supply and quality [304]. - The company may face challenges in scaling up manufacturing processes with CMOs, potentially delaying clinical trials and regulatory submissions [313]. Legal and Compliance Issues - The company must comply with various healthcare laws, including the federal Anti-Kickback Statute, which prohibits certain financial arrangements [422]. - The company may face significant penalties if found in violation of healthcare laws, which could harm future profits and operations [424]. - Legal proceedings related to intellectual property claims may be time-consuming and expensive, potentially leading to increased operating losses [354]. Management and Personnel - The company is highly dependent on key personnel, and loss of management could impede product development and commercialization efforts [435]. - The company does not maintain "key man" insurance for its key personnel, increasing risk in personnel turnover [436]. - The company plans to expand its employee base as it transitions to a public company, which may pose management challenges [439]. Cybersecurity and Data Risks - Cybersecurity threats and data breaches could lead to significant operational disruptions and reputational harm [445].
Nurix Therapeutics(NRIX) - 2024 Q4 - Annual Results
2025-01-28 21:03
Clinical Development - Nurix anticipates initiating a suite of late-stage clinical studies for NX-5948 in 2025, including pivotal studies for chronic lymphocytic leukemia (CLL) and expanding its development in additional cancer indications and inflammatory diseases[1] - The Phase 1a/1b clinical trial of NX-5948 demonstrated a robust objective response rate (ORR) of 75.5% among 49 efficacy-evaluable patients with relapsed or refractory CLL, increasing to 84.2% with longer treatment duration[3] - NX-5948 received Fast Track Designation from the U.S. FDA and PRIME designation from the European Medicines Agency for both CLL and Waldenstrom's macroglobulinemia[2] - Nurix reinitiated enrollment in the NX-2127 Phase 1a/b trial after lifting a manufacturing-related clinical hold, focusing on aggressive lymphomas[6] - The NX-1607 program is advancing with plans to establish a Phase 1b monotherapy dose and share additional clinical data following dose selection[11] - Nurix plans to explore regulatory paths for NX-5948 in treating autoimmune cytopenias, including warm autoimmune hemolytic anemia (wAIHA), in 2025[11] - Nurix anticipates nominating a STAT6 degrader development candidate in the first half of 2025, with a potential licensing option decision for Sanofi triggered by the delivery of a development candidate data package[12] - Nurix plans to nominate at least one development candidate from its wholly owned degrader pipeline to advance to IND-enabling studies in 2025[12] Financial Position - Nurix ended fiscal year 2024 with an estimated $609.6 million in cash and investments, positioning the company to fund operations into the first half of 2027[9] - The estimated cash and investment amount is a preliminary, unaudited estimate subject to financial closing procedures as of November 30, 2024[13] - Nurix's future financial performance and ability to fund operating activities into the first half of 2027 are subject to various risks and uncertainties[14] Collaborations and Partnerships - Nurix's collaboration with Gilead resulted in a $15 million payment for extending their research term, contributing to a total of $22 million earned from strategic collaborations in 2024[9] - The company retains options for co-development, co-commercialization, and profit sharing in the U.S. for multiple drug candidates under collaboration agreements with Gilead Sciences, Sanofi, and Pfizer[12] Drug Discovery and Innovation - The company is expanding its DEL-AI discovery engine to create novel degrader-based treatments, leveraging AI-powered drug discovery[3] - Nurix's drug discovery platform is powered by a fully AI-integrated discovery engine capable of tackling any protein class, enhancing its competitive advantage[12] - Nurix aims to establish degrader-based treatments at the forefront of patient care, focusing on innovative drug design[12] - The company is advancing multiple potentially first-in-class or best-in-class degraders and DACs in its preclinical pipeline[12] Forward-Looking Statements - Forward-looking statements reflect Nurix's current beliefs and expectations, but actual results may differ materially due to risks and uncertainties[14]
Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides a Corporate Update
Globenewswire· 2025-01-28 21:00
Core Insights - Nurix Therapeutics reported a robust objective response rate (ORR) of 75.5% from the Phase 1 study of NX-5948 in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [1][4] - The company received PRIME designation from the European Medicines Agency and Fast Track designation from the U.S. FDA for NX-5948 in CLL and Waldenstrom's Macroglobulinemia [1][4] - Nurix is well-capitalized with cash and marketable securities totaling $609.6 million as of November 30, 2024 [1][16] Clinical Development - NX-5948 is being evaluated for the treatment of relapsed or refractory B-cell malignancies, including CLL and Waldenstrom's macroglobulinemia [4][6] - The Phase 1 clinical trial showed an increase in ORR to 84.2% with longer treatment duration [4] - The drug was well-tolerated across all tested doses, ranging from 50 to 600 mg daily [4] Regulatory Designations - NX-5948 received Fast Track designation from the U.S. FDA for two indications: r/r CLL/SLL and r/r Waldenstrom's Macroglobulinemia [4][6] - The European Medicines Agency granted PRIME designation for NX-5948 in CLL [4] Financial Performance - For the fiscal year ended November 30, 2024, Nurix reported total revenue of $54.5 million, a decrease from $77.0 million in the previous year [13] - Research and development expenses increased to $221.6 million for the fiscal year, up from $189.1 million in 2023 [14] - The net loss for the year was $193.6 million, compared to a net loss of $143.9 million in the prior year [16] Leadership Changes - John Northcott was appointed as Chief Commercial Officer, bringing extensive experience in commercial leadership, including the commercialization of the first marketed BTK inhibitor [1][9]
Nurix Therapeutics Announces Appointment of John Northcott as Chief Commercial Officer
Globenewswire· 2025-01-22 12:00
Mr. Northcott brings over 20 years of biopharmaceutical experience building commercial organizations and successfully commercializing novel products, including BTK inhibitor ibrutinibSAN FRANCISCO, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the appointment of John Northcott as chief commercial officer (CCO). ...
Nurix Therapeutics Outlines 2025 Goals and Objectives for Advancement of Its Robust Pipeline in Cancer and Autoimmune Diseases
Globenewswire· 2025-01-13 12:00
Initiate a suite of clinical trials in 2025 intended to support global registration of NX-5948 for the treatment of chronic lymphocytic leukemia Expand the development of NX-5948 in additional cancer indications and inflammatory diseases Advance our portfolio of partnered programs in inflammation and immunology, including degraders of IRAK4 and STAT6 Invest in our highly productive DEL-AI discovery engine to create and advance novel degrader-based treatments in our wholly owned and partnered portfolios Main ...