On April 13, 2021 Nurix Therapeutics Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the first quarter ended February 28, 2021 and provided a corporate update (Press release, Nurix Therapeutics, APR 13, 2021, View Source [SID1234577979]).
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"We began 2021 with the initiation of our first clinical trial to evaluate NX-2127, an orally available degrader of Bruton’s tyrosine kinase with immunomodulatory drug activity in patients with relapsed or refractory B-cell malignancies," said Dr. Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We are on track to initiate Phase 1 trials for three more proprietary drug candidates in 2021 for patients with hematologic malignancies and solid tumors."
Recent Business Highlights
Expanded Strategic Collaboration with Sanofi S.A. (Sanofi): On January 7, 2021, Nurix announced the expansion of its global strategic collaboration with Sanofi to discover, develop and commercialize a pipeline of innovative targeted protein degradation drugs for patients with challenging diseases in multiple therapeutic areas. Sanofi has exercised its option to expand the number of targets in the collaboration agreement from three to a total of five targets. With the expansion, Nurix received a payment of $22 million, in addition to the previously received upfront payment of $55 million.
Completed a Public Follow-on Offering: On March 9, 2021, Nurix announced the closing of its underwritten public offering of 5,175,000 shares of 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 million, after deducting underwriting discounts, commissions and offering expenses.
Presented Preclinical Data Highlighting NX-1607: Nurix presented data from its NX-1607 program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 annual meeting which is being held virtually over two weeks, April 10-15 and May 17-21. NX-1607, an orally bioavailable, small-molecule inhibitor of Casitas B-lineage lymphoma B (CBL-B), demonstrated significant anti-tumor efficacy in animal models of both colorectal cancer and triple negative breast cancer. Importantly, the combination of NX-1607 and an anti-PD-1 antibody substantially increased the median overall survival and the frequency of long-lasting tumor rejection in these models compared to either single agent alone. The activity of NX-1607 was shown to be dependent on CD8+ T cells and NK cells. A copy of the poster can be found on Nurix’s website (link).
Announced Collaboration for the Discovery of Novel Drugs to Treat Pediatric Cancers: On March 16, 2021, Nurix announced that it is part of a collaboration sponsored by Alex’s Lemonade Stand Foundation (ALSF), a leading funder of pediatric cancer research, to develop a drug to potentially treat aggressive childhood cancers including neuroblastoma and medulloblastoma. Nurix will provide its extensive expertise in E3 ligases and use its proprietary DNA-encoded library to help identify small-molecule degraders of MYCN, a target previously considered undruggable. The program is one of four that are being supported by ALFS’s Crazy 8 initiative, which is designed to bring together world-class research talent to accelerate the pace of new cure discovery in childhood cancer.
Upcoming Program Highlights
NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally available degrader of Bruton’s tyrosine kinase (BTK) with immunomodulatory drug (IMiD) activity for the treatment of relapsed or refractory B-cell malignancies. Nurix filed an IND for NX-2127 in December 2020 and received clearance by the U.S. FDA to initiate human clinical trials. Clinical sites are actively recruiting patients for a Phase 1 clinical trial of NX-2127. 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 available inhibitor of CBL-B for immuno-oncology indications. Nurix anticipates initiating a Phase 1 trial for NX-1607 in the second half of 2021 (expected timing of events here and throughout the press release are based on calendar year quarters).
NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally available BTK degrader designed without IMiD activity for certain B-cell malignancies, autoimmune diseases and related diseases such as graft-versus-host disease. Nurix recently disclosed that NX-5948 crosses the blood brain barrier in animal models, further differentiating it from NX-2127. NX-5948 has also demonstrated potent anti-inflammatory activity in an animal model of rheumatoid arthritis. Nurix anticipates initiating a Phase 1 trial for NX-5948 in patients with hematologic malignancies in the second half of 2021.
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 First Quarter 2021 Financial Highlights
Collaboration revenue for the three months ended February 28, 2021 was $5.0 million compared to $2.9 million for the three months ended February 29, 2020. The increase was primarily due to our collaboration with Sanofi, which continued to scale up resources as compared to the prior period, resulting in higher revenue recognition due to a higher percentage of completion in the current period.
Research and development expenses for the three months ended February 28, 2021 were $23.0 million compared to $13.0 million for the three months ended February 29, 2020. The increase was primarily related to an increase of $4.6 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 $3.5 million attributable to increases in preclinical development activities and drug discovery research and an increase of $1.1 million due to preparation for upcoming clinical activities.
General and administrative expenses for the three months ended February 28, 2021 were $6.5 million compared to $2.5 million for the three months ended February 29, 2020. The increase was primarily related to an increase of $2.4 million in compensation related expenses attributable to a higher headcount and includes $1.4 million of higher non-cash stock-based compensation expense and an increase of $1.0 million in consultant and other professional service expenses primarily related to becoming a public company.
Net loss attributed to common stockholders for the three months ended February 28, 2021 was $24.3 million, or ($0.63) per share, compared to a net loss of $12.4 million, or ($3.50) per share, for the three months ended February 29, 2020.
Cash, Cash Equivalents and Investments: As of February 28, 2021, Nurix had cash, cash equivalents and investments of $380.3 million compared to $372.0 million as of November 30, 2020. Including net proceeds of $150.1 million from the recently completed follow-on offering, Nurix has proforma cash, cash equivalents and investments of $530.4 million.