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(NRIX) - 2024 Q4 - Annual Results