On July 7, 2022 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the second quarter ended May 31, 2022 and provided a corporate update (Press release, Nurix Therapeutics, JUL 7, 2022, View Source [SID1234616537]).
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"In the second quarter of 2022, we reported promising data in our Phase 1 trial of NX-2127 with clinical responses in CLL patients harboring tumor mutations that confer resistance to current BTK inhibitor therapies," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Our oncology drug discovery engine continues to hit on all cylinders. We are recruiting patients into clinical trials in all four of our wholly-owned programs, and we anticipate a data-rich second half of this year with information from each of the four clinical studies."
Recent Business Highlights
Announced Phase 1b expansion of the NX-2127 clinical trial for patients with chronic lymphocytic leukemia (CLL). Based on positive efficacy, safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from the Phase 1a dose escalation portion of the trial, Nurix initiated a Phase 1b expansion cohort in patients with CLL, which represents the first of several potential expansions. Relevant clinical and biomarker data supporting the decision were presented at the company’s first R&D Day, which was held in New York on May 26th (an archived webcast of the event can be accessed via the Events and Presentations page of the Investor section of the Nurix website). The dose-finding Phase 1a stage of the clinical trial of NX-2127 continues in other non-Hodgkin lymphoma subtypes.
Provided a deep dive into Nurix’s platform and progress in its targeted protein modulation programs at the company’s first R&D Day. In addition to providing an update on each of Nurix’s four wholly owned clinical programs and highlighting the company’s DELigase R&D platform, which serves as the source of current and future programs, Nurix’s R&D Day featured a presentation by Anthony Mato M.D., MSCE, Director of the CLL program at Memorial Sloan Kettering Cancer Center. Dr. Mato outlined the unmet medical need in CLL and the growing problem of resistance and intolerance to current and next generation Bruton’s tyrosine kinase (BTK) inhibitors including the emergence of new drug resistance mutations that may be addressed by Nurix’s portfolio of BTK degraders (NX-2127 and NX-5948). An archived webcast of the event can be accessed via the Events and Presentations page of the Investor section of the Nurix website.
Announced dosing of the first patient in its Phase 1a/1b study to evaluate NX-5948 in patients with relapsed B-cell malignancies. The Phase 1 study of NX-5948, a potent and selective degrader of BTK, is a dose escalation and expansion trial at multiple clinical sites in the United Kingdom. The trial is designed to evaluate the safety and tolerability of NX-5948 in adults with relapsed or refractory B-cell malignancies.
Presented data and clinical trial information at key oncology meetings. Data and clinical trial design presentations for each of Nurix’s wholly owned programs were made at major oncology clinical and scientific meetings including the annual meetings of the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) in April, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, the European Hematology Association (EHA) (Free EHA Whitepaper) in June, and the Translational Research Cancer Centers Consortium (TRCCC) in June. The presentations can be found in the Scientific Presentations section of the Events and Presentations page of the Investor section of the Nurix website.
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. Nurix is conducting its Phase 1 clinical trial of NX-2127 at multiple clinical sites in the United States. Nurix anticipates presenting additional clinical results from the Phase 1a portion of the trial in the second half of 2022. Additional information on the clinical trial can be accessed at 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 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 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 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. 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 the second half of 2022. Additional information on the clinical trial can be accessed at 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 providing a clinical update from the run-in portion of the DeTIL-0255 Phase 1 study in the second half of 2022. Additional information on the clinical trial can be accessed at clinicaltrials.gov (NCT05107739).
* Expected timing of events throughout the press release are based on calendar year quarters.
Fiscal Second Quarter 2022 Financial Highlights
Collaboration revenue for the three months ended May 31, 2022, was $11.4 million compared to $7.1 million for the three months ended May 31, 2021. The increase was primarily due to increased effort resulting in a higher percentage of completion of performance obligations under Nurix’s collaborations with Gilead and Sanofi in the current period. The increase was also due to changes in transaction price that resulted in higher revenue recognized in each period and impacted the cumulative catch up in revenue for activities satisfied in previous periods. In the three months ended May 31, 2022, Nurix achieved a research milestone under its collaboration with Gilead and anticipates a payment of $1.5 million in the third fiscal quarter of 2022.
Research and development expenses for the three months ended May 31, 2022, were $47.5 million compared to $26.0 million for the three months ended May 31, 2021. The increase was primarily related to an increase of $7.2 million in compensation and related personnel costs and an increase of $2.0 million in non-cash stock-based compensation expense attributable to higher headcount. The increase in non-cash stock-based compensation expense was also attributable to the issuance of restricted stock units. There was also an increase of $10.0 million in supplies, contract research, contract manufacturing and clinical trial costs.
General and administrative expenses for the three months ended May 31, 2022, were $9.7 million compared to $7.5 million for the three months ended May 31, 2021. The increase was primarily related to an increase of $0.6 million in compensation-related expenses and an increase of $0.9 million in non-cash stock-based compensation expense, both of which were primarily attributable to higher headcount. There was also an increase of $0.6 million in professional service expenses, including legal and accounting expenses related to infrastructure improvements.
Net loss for the three months ended May 31, 2022, was $45.4 million, or ($1.01) per share, compared to a net loss of $26.4 million, or ($0.60) per share for the three months ended May 31, 2021.
Cash, cash equivalents and investments: As of May 31, 2022, Nurix had cash, cash equivalents and investments of $348.8 million compared to $385.7 million as of February 28, 2022.