On April 13, 2023 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, reported financial results for the first quarter ended February 28, 2023 and provided a corporate update (Press release, Nurix Therapeutics, APR 13, 2023, View Source [SID1234630090]).
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"Nurix had a strong start to 2023 with the recent announcement that Gilead has licensed the first of our five collaboration programs, a targeted protein degrader of IRAK4, triggering a $20 million payment to Nurix and setting the stage for potential achievement of additional milestone payments," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "The advancement of our IRAK4 program marks the achievement of one of our key goals in 2023 and highlights the capability of our platform to create drug candidates for therapeutic areas outside oncology such as inflammatory disease. We look forward to the continued advancement of our exciting pipeline including our wholly owned and partnered programs."
Recent Business Highlights
•Gilead exercised option to license Nurix’s IRAK4 targeted protein degrader: In March, the companies announced that Gilead exercised its option to exclusively license Nurix’s investigational targeted protein degrader NX-0479, now also designated GS-6791. This is the first development candidate resulting from the 2019 Nurix-Gilead collaboration to discover, develop and commercialize a pipeline of innovative targeted protein degradation therapies. GS-6791 is a potent, selective, oral IRAK4 degrader that targets both the kinase and scaffold functions of the IRAK4 to block inflammatory responses and has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. Nurix could potentially receive up to an additional $425 million in clinical, regulatory, and commercial milestone payments, as well as up to low double-digit tiered royalties on product net sales.
•Nurix presented data detailing the chemical structure of NX-2127 at the American Chemical Society Spring 2023 Meeting: Nurix disclosed the structure of NX-2127 and described in detail its pre-clinical characterization and early human pharmacokinetic data in a presentation titled "First disclosure of NX-2127, an oral targeted degrader of Bruton’s tyrosine kinase (BTK) with concurrent immunomodulatory activity for the treatment of B-cell malignancies."
Upcoming Program Highlights*
•NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory activity for the treatment of patients with relapsed or refractory B-cell malignancies. At this month’s upcoming annual meeting of the American Society for Cancer Research (AACR) (Free AACR Whitepaper), Nurix plans to present preclinical data including the discovery, structure-activity relationships, and pre-clinical characterization of NX-2127.
Nurix is conducting a Phase 1 clinical trial of NX-2127 and anticipates presenting additional clinical results in the second half of 2023. Nurix also anticipates defining a regulatory strategy for NX-2127 in the second half of 2023 based on emerging clinical data and feedback from the FDA. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
•NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without immunomodulatory activity. At the AACR (Free AACR Whitepaper) meeting later this month, Nurix expects to present preclinical data demonstrating potent and sustained degradation activity of NX-5948 against a variety of clinically relevant BTK resistance mutants.
Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to present initial clinical data from the Phase 1a portion of the study in the second half of 2023. In addition, Nurix expects to define a dose for Phase 1b cohort expansion. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).
•NX-1607: Nurix’s lead drug candidate from its targeted protein elevation portfolio, NX-1607, is an orally bioavailable inhibitor of the E3 ligase CBL-B for immuno-oncology indications including a range of solid tumor types and lymphoma. Nurix is evaluating NX-1607 in an ongoing, Phase 1 trial in adults with a variety of oncology indications and expects to present clinical data from the Phase 1a portion of the study and to define a dose for Phase 1b cohort expansion in the second half of 2023. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
•NX-0479 /GS-6791: Nurix’s development candidate, now designated GS-6791 is a potent, selective, oral IRAK4 degrader. Degradation of IRAK4 by GS-6791 has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases.
•Continued advancement of strategic collaborations with Gilead Sciences and Sanofi: Nurix expects to continue to achieve substantial research collaboration milestones throughout 2023 from its collaborations with Gilead Sciences and Sanofi.
*Expected timing of events throughout the press release are based on calendar year quarters.
Fiscal First Quarter 2023 Financial Results
Collaboration revenue for the three months ended February 28, 2023 was $12.7 million compared to $9.6 million for the three months ended February 28, 2022. The increase was primarily due to a higher percentage of completion of performance obligations in the current period. During the three months ended February 28, 2023, we achieved research milestones under the collaboration with Gilead and Sanofi totaling $6.5 million and $1.0 million, respectively.
Research and development expenses for the three months ended February 28, 2023 were $45.8 million compared to $43.1 million for the three months ended February 28, 2022. The increase was primarily related to an increase in compensation and related personnel costs, including in non-cash stock-based compensation expense, attributable to higher headcount, and an increase in clinical costs as we continue our clinical trial programs and ongoing patient enrollment, offset by a general decrease in research related costs.
General and administrative expenses for the three months ended February 28, 2023 were $9.8 million compared to $9.2 million for the three months ended February 28, 2022. The increase was primarily related to an increase in compensation related expenses and non-cash stock-based compensation expense, offset by a general decrease in outside consulting and professional service costs.
Net loss for the three months ended February 28, 2023 was $40.7 million, or ($0.75) per share, compared to a net loss of $42.5 million for the three months ended February 28, 2022, or ($0.95) per share.
Cash, cash equivalents and marketable securities was $325.6 million as of February 28, 2023 compared to $373.0 million as of November 30, 2022.