Nurix Therapeutics(US:NRIX)2025-07-09 20:03PART I. FINANCIAL INFORMATION Financial Statements (Unaudited) The company reported increased revenue and a higher net loss due to rising R&D expenses, leading to increased cash used in operations Condensed Balance Sheets Condensed Balance Sheet Highlights | Account | May 31, 2025 (in thousands) | November 30, 2024 (in thousands) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $84,260 | $109,997 | | Marketable securities, current | $401,521 | $499,586 | | Total current assets | $515,330 | $619,387 | | Total assets | $591,555 | $669,343 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $75,614 | $95,854 | | Total liabilities | $143,952 | $142,350 | | Total stockholders' equity | $447,603 | $526,993 | | Accumulated deficit | $(838,584) | $(738,769) | Condensed Statements of Operations Condensed Statements of Operations Highlights | Metric | Three Months Ended May 31, 2025 (in thousands) | Three Months Ended May 31, 2024 (in thousands) | Six Months Ended May 31, 2025 (in thousands) | Six Months Ended May 31, 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $14,056 | $12,092 | $32,509 | $28,677 | | License revenue | $30,000 | $— | $30,000 | $— | | Total revenue | $44,056 | $12,092 | $62,509 | $28,677 | | Research and development | $78,096 | $48,922 | $147,759 | $98,927 | | General and administrative | $14,282 | $11,710 | $25,936 | $23,509 | | Total operating expenses | $92,378 | $60,632 | $173,695 | $122,436 | | Net loss | $(43,464) | $(44,546) | $(99,815) | $(86,064) | | Net loss per share | $(0.52) | $(0.71) | $(1.19) | $(1.47) | Condensed Statements of Cash Flows Condensed Statements of Cash Flows Highlights | Activity | Six Months Ended May 31, 2025 (in thousands) | Six Months Ended May 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(124,248) | $(81,656) | | Net cash provided by (used in) investing activities | $97,032 | $(95,557) | | Net cash provided by financing activities | $1,479 | $239,376 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(25,737) | $62,163 | Notes to Condensed Financial Statements - The company is a clinical-stage biopharmaceutical firm leveraging its DEL-AI platform to develop small molecule and antibody therapies for cancer and inflammatory diseases, with a pipeline including wholly-owned candidates and partnered programs with Gilead, Sanofi, and Pfizer32 - Management believes its cash, cash equivalents, and marketable securities totaling $485.8 million as of May 31, 2025, are sufficient to fund operating activities for at least 12 months41 - Sanofi's exercise of exclusive license rights for two development candidates in March and May 2025 generated $30.0 million in license revenue for Nurix during the second quarter of fiscal year 20257683 - A new lease agreement in Brisbane, CA for approximately 159,959 sq. ft. of R&D and office space in February 2025 resulted in a $26.7 million right-of-use asset and lease liability108 Management's Discussion and Analysis of Financial Condition and Results of Operations The company's net loss increased due to higher R&D expenses, despite revenue growth, while maintaining sufficient liquidity for the next 12 months Overview - Nurix is a clinical-stage biopharmaceutical company focused on targeted protein degradation utilizing its DEL-AI discovery engine131 - The wholly-owned clinical pipeline features BTK degraders bexobrutideg (NX-5948) and zelebrudomide (NX-2127), alongside CBL-B inhibitor NX-1607131132135 - Major collaborations with Gilead, Sanofi, and Pfizer have provided $482.0 million in non-dilutive financing to date, with potential for up to $6.1 billion in future fees and milestones138 - Bexobrutideg (NX-5948) received Fast Track designation from the FDA for CLL/SLL and WM, and Orphan Drug Designation from both the FDA and EMA for WM/lymphoplasmacytic lymphoma, with a Phase 2 trial expected to commence in 2025133 Results of Operations Comparison of Operations | Item | Six Months Ended May 31, 2025 (in thousands) | Six Months Ended May 31, 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Total revenue | $62,509 | $28,677 | $33,832 | | Research and development | $147,759 | $98,927 | $48,832 | | General and administrative | $25,936 | $23,509 | $2,427 | | Net loss | $(99,815) | $(86,064) | $(13,751) | - $30.0 million in license revenue for the three and six months ended May 31, 2025, was recognized from the Sanofi License Extensions184 - R&D expenses increased by $48.8 million for the six months ended May 31, 2025, primarily due to higher clinical, manufacturing, and consulting costs to accelerate bexobrutideg (NX-5948) enrollment and prepare for pivotal trials185 Liquidity and Capital Resources - As of May 31, 2025, the company held $485.8 million in cash, cash equivalents, and marketable securities196 - Management anticipates existing cash will be sufficient to fund operations for at least the next 12 months197 - Net cash used in operating activities increased to $124.2 million for the six months ended May 31, 2025, from $81.7 million in the prior year, driven by a higher net loss and working capital changes, including a $19.0 million increase in accounts receivable from the Sanofi license extension203204 - Net cash provided by financing activities was $1.5 million in the first six months of fiscal 2025, significantly lower than $239.4 million in the prior year period, which included proceeds from a public offering and ATM financing207 Quantitative and Qualitative Disclosures About Market Risk The company reports no material changes in market risks since its last Annual Report on Form 10-K - No material changes in market risks have occurred since the Annual Report on Form 10-K filed on January 28, 2025208 Controls and Procedures Management concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of May 31, 2025210 - No changes materially affected internal control over financial reporting during the quarter211 PART II. OTHER INFORMATION Legal Proceedings The company is not currently involved in any material legal proceedings - As of the report date, the company is not a party to any material legal proceedings214 Risk Factors The company faces substantial risks including financial losses, early-stage pipeline uncertainty, reliance on third parties, commercialization challenges, and regulatory hurdles Risks Related to Our Financial Position and Need for Additional Capital - The company has a history of significant losses, with a net loss of $99.8 million for the six months ended May 31, 2025, and an accumulated deficit of $838.6 million, expecting continued losses for several years216 - Substantial additional funding is required to advance clinical trials, expand the DEL-AI platform, and support potential commercialization, with failure to raise capital risking program delays or termination222 Risks Related to the Discovery and Development of Our Drug Candidates - The company's lead drug candidates are in early-stage clinical development, a phase with a high risk of failure231 - The targeted protein degradation platform is a novel and unproven approach, making development time, cost, and success likelihood difficult to predict235 - The company faces substantial competition from major pharmaceutical and biotech companies possessing greater financial resources and expertise in R&D, manufacturing, and commercialization261263 Risks Related to Dependence on Third Parties - The company depends on collaborations with Gilead, Sanofi, and Pfizer for R&D of certain drug candidates, with program success reliant on collaborators' performance and strategic decisions269271 - Nurix relies on third-party CROs for clinical trials and CMOs for drug candidate supply, increasing risks related to quality, cost, and timeliness276279 Risks Related to Regulatory Approval and Marketing of Our Drug Candidates - The regulatory approval process is lengthy, costly, and unpredictable, with no guarantee that any drug candidates will obtain marketing approval346 - Approved products are subject to ongoing regulation, post-marketing restrictions, and potential market withdrawal if safety or efficacy issues emerge366370 - Healthcare legislation, including the Inflation Reduction Act (IRA), and foreign price controls could negatively impact drug pricing and reimbursement, affecting future profitability404406410 Risks Related to Our Common Stock - The company's stock price may be highly volatile due to factors like clinical trial results, regulatory developments, and market conditions463 - Future sales of common stock to raise capital, including through the existing "at the market" facility, will dilute existing stockholders' ownership467470 - Anti-takeover provisions in the company's charter and Delaware law could hinder beneficial acquisitions and prevent stockholders from replacing management474475 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities490 Other Information No director or Section 16 officer adopted or terminated a Rule 10b5-1 trading arrangement during the quarter - No director or Section 16 officer adopted or terminated a Rule 10b5-1 trading arrangement in the quarter494 Exhibits This section lists the exhibits filed with the Form 10-Q, including an amendment to a sublease agreement, officer certifications, and XBRL data files