On January 27, 2022 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the fourth quarter and fiscal year ended November 30, 2021 and provided a corporate update (Press release, Nurix Therapeutics, JAN 27, 2022, View Source [SID1234607439]).
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"2021 was a remarkable year for Nurix with the advancement of four wholly owned drug candidates into clinical development. We are very encouraged by our early clinical results having obtained positive proof-of-mechanism data from all patients treated in the first two cohorts with advanced B-cell malignancies," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We look forward to an exciting year as we advance our proprietary protein modulation portfolio for patients with significant unmet medical need in both solid tumors and hematologic malignancies."
Recent Business Highlights
Initiated Phase 1 clinical development for four wholly owned and internally developed drug candidates: Nurix proprietary protein modulation clinical programs include two targeted protein degraders of Bruton’s tyrosine kinase (BTK), NX-2127 and NX-5948, for the treatment of relapsed and refractory B-cell malignancies, a first-in-class oral E3 ligase inhibitor, NX-1607, for the treatment of a variety of solid tumors and hematologic malignancies, and a first-in-class cell therapy program, DeTIL-0255, that combines tumor infiltrating lymphocytes (TIL) with a small molecule E3 ligase inhibitor with the aim of generating a superior T-cell product with enhanced efficacy.
Presented initial data from its first-in-human, Phase 1 dose-escalation trial of NX-2127 in adults with relapsed or refractory B-cell malignancies: In October 2021, Nurix reported initial pharmacokinetic (PK) and pharmacodynamic (PD) data from the first six patients in its Phase 1a clinical trial of NX-2127, including completed cohorts 1 and 2 treated at 100 mg and 200 mg once daily. The data showed BTK levels in peripheral blood significantly decreased in all patients in the trial starting on day 1 and remained suppressed throughout the dosing period. BTK degradation exceeded 80% at steady state in the first dose cohort and exceeded 90% in the second dose cohort. Such levels of BTK degradation have been associated with anti-tumor effects in preclinical animal models. Clinical observations were presented for the one patient in cohort 1, a 78-year-old man with chronic lymphocytic leukemia (CLL) and significant mutations in the BTK gene associated with resistance to standard of care BTK inhibitors, who achieved a partial remission with lymphocytosis.
Strengthened financial position: In March 2021, Nurix completed an underwritten public offering of 5,175,000 shares of its common stock, at a public offering price of $31.00 per share, which included 675,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock. The net proceeds to Nurix from the offering were approximately $150.2 million, after deducting underwriting discounts, commissions and offering expenses. Combined with additional capital from partners in 2021, Nurix ended fiscal year 2021 with $432.9 million in cash and equivalents compared to $372.0 million as of November 30, 2020.
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 drug (IMiD) activity. Nurix plans to initiate the Phase 1b expansion phase of its ongoing Phase 1a/1b clinical trial of NX-2127 in adults with relapsed or refractory B-cell malignancies in mid-2022 and to present additional data from Phase 1a in the second half of 2022. 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 IMiD activity for certain B-cell malignancies and autoimmune diseases. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to begin dosing at multiple clinical centers in the United Kingdom in the first half of 2022 and to have initial safety and PK/PD data from the Phase 1a portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).
NX-1607: Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for immuno-oncology indications including a range of solid tumor types. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in mid-2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Nurix anticipates dosing the first patient in the first half of 2022 and providing a clinical update from the run-in portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107739).
Fiscal Fourth Quarter and Full Year 2021 Financial Results
Collaboration revenue for the three months and twelve months ended November 30, 2021 was $7.4 million and $29.8 million, respectively, compared with $6.7 million and $17.8 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily due to the continued scale up of internal resources and external spending for Nurix’s collaborations with Sanofi and Gilead as compared to the prior year, resulting in a higher percentage of completion in the current year. The increase was also due to partial revenue recognized during the year ended November 30, 2021 for the achievement of certain preclinical milestones under Nurix’s collaborations with Gilead and Sanofi.
Research and development expenses for the three months and twelve months ended November 30, 2021 were $36.5 million and $116.4 million, respectively, compared with $20.4 million and $66.5 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily related to an increase in compensation and personnel costs attributable to an increase in headcount; increases in supplies and contract research, preclinical activities and contract manufacturing costs attributable to an increase in Nurix’s preclinical development activities and drug discovery research and preparation for upcoming clinical programs for its lead drug candidates; an increase in clinical costs due to ongoing clinical trial startup and patient enrollment; an increase in non-cash stock-based compensation expense; and an increase in facility and other costs primarily due to the expansion of leased premises and investments in information technology.
General and administrative expenses for the three months and twelve months ended November 30, 2021 were $8.8 million and $31.2 million, respectively, compared with $6.3 million and $16.3 million for the three and twelve months ended November 30, 2020, respectively. The increase for the twelve-month period was primarily related to non-cash stock-based compensation expense, compensation related expenses attributable to higher headcount, and consultant and other professional services costs primarily related to becoming a public company.
Net loss for the three months and twelve months ended November 30, 2021 was $37.7 million or ($0.85) per share and $117.2 million or ($2.73) per share, respectively, compared with $19.9 million or ($0.51) per share and $43.2 million or ($2.76) per share for the three and twelve months ended November 30, 2020, respectively.
Cash, cash equivalents and investments: As of November 30, 2021, Nurix had cash, cash equivalents and investments of $432.9 million, compared with $372.0 million as of November 30, 2020.