On October 12, 2023 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, reported financial results for the fiscal quarter ended August 31, 2023, and provided a corporate update (Press release, Nurix Therapeutics, OCT 12, 2023, View Source [SID1234635888]).

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"As our drug development pipeline continues to advance in the clinic, we are excited to add to our pipeline with Seagen to advance a portfolio of Degrader-Antibody Conjugates, or DACs, a new class of highly selective cancer therapeutics," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Nurix enters the fourth quarter of 2023 in a strong financial position due to our ability to access significant revenue from corporate partners including our recently announced agreement with Seagen and ongoing strategic collaborations with Gilead and Sanofi."

Recent Business Highlights

•Nurix announced a first of its kind strategic collaboration with Seagen: In September, Nurix entered a collaboration with Seagen to develop a portfolio of Degrader-Antibody Conjugates (DACs): antibodies that deliver a targeted protein degrader payload to selectively kill cancer cells. Nurix received a $60 million upfront payment and has the potential to receive approximately $3.4 billion in milestone payments plus future royalties. Nurix also retains an option for U.S. profit sharing and co-promotion on two products arising from the collaboration. In addition, Nurix announced that with the receipt of the $60 million upfront payment, Nurix expects that its existing cash, cash equivalents and marketable securities, excluding any future potential milestones from collaborations, will be sufficient to fund its operating activities into the second quarter of 2025.

•Nurix expanded its Phase 1a trial of NX-1607 to include a combination with paclitaxel: In August, Nurix treated the first patient with NX-1607 in combination with paclitaxel. The decision to initiate combination trials was informed by the evolving safety and activity data from Phase 1a.

Upcoming Program Highlights*

•NX-5948: NX-5948 is an orally bioavailable degrader of Bruton’s tyrosine kinase (BTK) designed without immunomodulatory activity. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to present initial clinical data from the Phase 1a portion of the study in the second half of 2023. In addition, Nurix expects to define a dose for the Phase 1b cohort expansion in the second half of 2023. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).

•NX-2127: 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 a Phase 1 clinical trial of NX-2127, which includes three Phase 1b expansion cohorts in patients with diffuse large B cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). Nurix anticipates presenting additional clinical results from this ongoing trial in the second half of 2023. Nurix also anticipates defining a regulatory strategy for NX-2127 in the second half of 2023 based on emerging clinical data and feedback from the FDA. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).

•NX-1607: Nurix’s lead drug candidate from its targeted protein elevation portfolio, NX-1607, is an orally bioavailable inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for immuno-oncology indications including a range of solid tumor types and lymphoma. Nurix is evaluating NX-1607 in an ongoing, Phase 1a dose escalation trial in monotherapy and in a combination cohort utilizing paclitaxel in adults in a range of oncology indications. Nurix expects to present clinical data from the Phase 1a portion of the study and to define a dose for Phase 1b cohort expansion in the second half of 2023. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

•NX-0479/GS-6791: GS-6791 (previously NX-0479) is a potent, selective, oral IRAK4 degrader. Degradation of IRAK4 by GS-6791 has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. Nurix’s partner, Gilead Sciences, is responsible for conducting IND-enabling studies and advancing this program to clinical development.

•Continued advancement of strategic collaborations with Gilead and Sanofi: Nurix expects to continue to achieve substantial research collaboration milestones throughout the terms of its collaborations with Gilead and Sanofi.
*Expected timing of events throughout this press release is based on calendar year quarters.

Fiscal Third Quarter 2023 Financial Results

Revenue for the three months ended August 31, 2023, was $18.5 million compared to $10.8 million for the three months ended August 31, 2022. The increase was primarily due to a higher percentage of completion of performance obligations and an increase in the value of milestones achieved in the current period. During the three months ended August 31, 2023, Nurix achieved research milestones under its collaborations with Gilead and Sanofi totaling $6.0 million and $2.0 million, respectively.

Research and development expenses for the three months ended August 31, 2023, were $47.9 million compared to $47.8 million for the three months ended August 31, 2022. There was an increase in clinical costs as Nurix continued its clinical trial programs and ongoing patient enrollment, primarily offset by a decrease in research related costs and in contract manufacturing. There was also an increase in facility and other costs primarily driven by additional investments in information technology and lease related expenses.

General and administrative expenses for the three months ended August 31, 2023, were $10.6 million compared to $9.7 million for the three months ended August 31, 2022. The increase was primarily related to an increase in non-cash stock-based compensation expense and an increase in professional service costs related to the Seagen collaboration agreement, offset by a decrease in outside consulting costs.

Net loss for the three months ended August 31, 2023, was $37.0 million, or ($0.68) per share, compared to a net loss of $45.7 million for the three months ended August 31, 2022, or ($0.90) per share.
Cash, cash equivalents and marketable securities was $268.7 million as of August 31, 2023, compared to $308.6 million as of May 31, 2023.