On October 6, 2022 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the third quarter ended August 31, 2022 and provided a corporate update (Press release, Nurix Therapeutics, OCT 6, 2022, View Source [SID1234621774]).
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"The third quarter was highly productive for Nurix with continued progress in our development programs, expansion of our leadership team and the completion of significant registered direct offerings that enabled us to strengthen our balance sheet," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We look forward to maintaining our momentum into the end of year as we continue to execute on the clinical trials of our wholly owned programs and provide important updates through the remainder of the year."
Recent Business Highlights
Strengthened the balance sheet with two registered direct offerings raising gross proceeds of $95 million: Nurix entered into two securities purchase agreements with healthcare-focused investment funds to sell, in registered direct offerings, pre-funded warrants to purchase an aggregate of 6,814,920 shares of Nurix’s common stock at a price of $13.939 per pre-funded warrant, cumulatively yielding total gross proceeds of $95 million.
Expanded the Nurix leadership team and board with the hiring of chief people officer and the appointment of leading industry strategist to the board of directors: In August, Nurix announced that industry veteran, Eric Schlezinger, J.D., joined the company as chief people officer. Mr. Schlezinger has extensive experience leading and developing human resources at high-growth private and public biopharma companies. In September, Nurix announced the appointment of leading industry strategist Edward C. Saltzman to its board of directors. Mr. Saltzman has over 30 years of drug strategic development experience and currently serves as Head of Biotech Strategy at Lumanity Inc., a global pharmaceutical and biotechnology advisory firm.
Announced acceptance of six abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (November 8-12, 2022): Nurix will have six poster presentations at the meeting, including a presentation of initial biomarker data from the Phase 1 clinical trial of NX-1607, a first-in-class oral inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B) in patients with advanced 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. Nurix is conducting its Phase 1 clinical trial of NX-2127 at multiple clinical sites. Nurix anticipates presenting additional clinical results from the Phase 1a portion of the trial by the end 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 PK/PD data from the Phase 1a portion of the study by the end 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 and expects to present initial PK/PD data from the Phase 1a stage of the study at the SITC (Free SITC Whitepaper) 2022 annual meeting. 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 by the end 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 Third Quarter 2022 Financial Highlights
Collaboration revenue for the three months ended August 31, 2022 was $10.8 million compared to $10.3 million for the three months ended August 31, 2021. The increase was primarily 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 in the current period. In the three months ended August 31, 2022, Nurix achieved a research milestone under its collaboration with Gilead and anticipates a payment of $2.5 million in the fourth fiscal quarter of 2022.
Research and development expenses for the three months ended August 31, 2022 were $47.8 million compared to $30.9 million for the three months ended August 31, 2021. The increase was primarily related to an increase of $7.3 million in compensation and related personnel costs and an increase of $2.0 million in non-cash stock-based compensation expense primarily attributable to an increase in headcount. In addition, there was an increase of $5.3 million in supplies and contract research and preclinical and clinical costs due to ongoing clinical trial startup and patient enrollment and preclinical and drug discovery activities.
General and administrative expenses for the three months ended August 31, 2022 were $9.7 million compared to $8.3 million for the three months ended August 31, 2021. The increase was primarily related to an increase of $0.3 million in compensation related expenses and an increase of $0.7 million in non-cash stock-based compensation expense. There was also an increase of $0.4 million in professional service and consulting expenses.
Net loss for the three months ended August 31, 2022 was $45.7 million, or ($0.90) per share, compared to a net loss of $28.8 million for the three months ended August 31, 2021, or ($0.65) per share.
Cash, cash equivalents and marketable securities: As of August 31, 2022, Nurix had cash, cash equivalents and marketable securities of $413.6 million compared to $348.8 million as of May 31, 2022. The increase was primarily attributable to $95.0 million of gross proceeds from two registered direct offerings of pre-funded warrants to purchase Nurix common stock that were completed in July 2022.