On July 13, 2021 Nurix Therapeutics Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the second quarter ended May 31, 2021 and provided a corporate update (Press release, Nurix Therapeutics, JUL 13, 2021, View Source [SID1234584813]).
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"Our first clinical trial to evaluate NX-2127, an orally bioavailable degrader of Bruton’s tyrosine kinase with immunomodulatory drug activity in patients with relapsed or refractory B-cell malignancies is actively recruiting, and we anticipate sharing preliminary data from the dose escalation by year-end 2021," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "The second half of 2021 promises to be an exciting time for Nurix as we prepare to deliver on our ambitious goal of initiating Phase 1 trials for three additional wholly owned and internally developed drug candidates."
Recent Business Highlights
Expanded the Leadership Team with the Addition of a Chief Operating Officer: Nurix announced the appointment of Stefani A. Wolff as chief operating officer and executive vice president of product development. Ms. Wolff brings to Nurix over 30 years of leadership experience in oncology and immunology most recently from Principia Biopharma Inc., where she served as chief development officer and formerly senior vice president of strategy and operations overseeing Principia’s portfolio including Bruton’s tyrosine kinase (BTK) targeted agents.
Strengthened the Board of Directors with a Highly Successful Biotechnology Executive: Nurix announced the appointment of Clay Siegall, Ph.D., president, chief executive officer and chairman of Seagen (formerly Seattle Genetics, Inc.), to its board of directors. Dr. Siegall is an industry leader with a remarkable track record of success in building Seagen from a drug discovery platform company to a commercial-stage oncology company with multiple products. Dr. Siegall co-founded Seagen in 1998, which today has three FDA-approved medicines and is an industry leader in antibody-drug conjugate technology and development.
Presented Preclinical Data Highlighting Activity of NX-5948 in Animal Models of Autoimmune Disease: Nurix presented preclinical data for NX-5948 at the European Alliance of Associations for Rheumatology (EULAR) 2021 Virtual Congress in June 2021. The data presented at the EULAR Congress demonstrate that NX-5948 is a highly selective and potent degrader of BTK in primary human B cells resulting in robust inhibition of B cell activation. Importantly, data obtained from a mouse model of collagen-induced arthritis (CIA) demonstrated that in mice treated with NX-5948, symptoms of arthritis improved, with a significant reduction in arthritis clinical score, superior disease-related symptom control relative to ibrutinib, and similar activity to that of dexamethasone. A copy of the poster can be found on Nurix’s 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 drug (IMiD) activity for the treatment of relapsed or refractory B-cell malignancies. Nurix is actively recruiting patients at multiple clinical sites for a Phase 1 clinical trial of NX-2127. Initial pharmacokinetic (PK) and pharmacodynamic (PD) data from the dose escalation portion of the trial is anticipated by year-end 2021 (expected timing of events here and throughout the press release are based on calendar year quarters). Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT04830137).
NX-1607: Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of CBL-B for immuno-oncology indications. Nurix anticipates initiating a Phase 1 trial for NX-1607 in the second half of 2021.
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 anticipates initiating a Phase 1 trial for NX-5948 in patients with hematologic malignancies in the second half of 2021 and is planning for the potential expansion of indications into selected autoimmune diseases in 2022.
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix anticipates initiating a Phase 1 trial for DeTIL-0255 in the second half of 2021.
Fiscal Second Quarter 2021 Financial Highlights
Collaboration revenue for the three months ended May 31, 2021 was $7.1 million compared to $4.2 million for the three months ended May 31, 2020. The increase was due to the continued scale up of internal resources and external spending for our collaborations with Sanofi and Gilead as compared to the prior period, resulting in a higher percentage of completion and therefore more revenue recognized in the current period.
Research and development expenses for the three months ended May 31, 2021 were $26.0 million compared to $14.1 million for the three months ended May 31, 2020. The increase was primarily related to an increase of $5.3 million in compensation and related personnel costs attributable to an increase in headcount and higher non-cash stock-based compensation expense. There was also an increase of $4.7 million attributable to increases in preclinical development activities and drug discovery research and an increase of $1.1 million in clinical costs due to the start of clinical trial patient enrollment.
General and administrative expenses for the three months ended May 31, 2021 were $7.5 million compared to $3.3 million for the three months ended May 31, 2020. The increase was primarily related to an increase of $3.0 million in compensation related expenses attributable to a higher headcount and higher non-cash stock-based compensation expense. There was also an increase of $1.1 million in consultant and other professional service expenses primarily related to becoming a public company.
Net loss for the three months ended May 31, 2021 was $26.4 million, or ($0.60) per share, compared to net income of $7.6 million for the three months ended May 31, 2020, or $0.00 per share attributable to common shareholders under accounting rules associated with Nurix preferred shares prior to their conversion to common shares on July 28, 2020.
Cash, Cash Equivalents and Investments: As of May 31, 2021, Nurix had cash, cash equivalents and investments of $496.5 million compared to $372.0 million as of November 30, 2020. The increase was primarily attributable to the net proceeds of $150.1 million from Nurix’s follow-on offering in March 2021.