Group 1 - The discussion focuses on targeted protein degradation as an evolving therapeutic modality, highlighting its place among successful treatments like antibodies and nucleic acid-based therapies [2][3] - Targeted protein degraders represent a small molecule approach that can effectively remove entire proteins, offering advantages such as oral administration and once-a-day dosing [3][4] - This method is positioned as having antibody-like or biologic-like efficacy, potentially surpassing the effectiveness of traditional nucleic acid-based therapies and antibodies [4]

Core Insights - The conference is hosted by Morgan Stanley, featuring Nurix with CEO Arthur Sands presenting the company's strategic priorities [1][2] Company Overview - Nurix is currently focusing on its strategic priorities and overall company status, as highlighted by the CEO during the conference [2]

Company Overview - Nurix is being hosted at a conference by Morgan Stanley, with Arthur Sands serving as the President and CEO [1] - The conference aims to discuss the company's current standing and strategic priorities [2]

Summary of Nurix Therapeutics FY Conference Call Company Overview - **Company**: Nurix Therapeutics (NasdaqGM:NRIX) - **Date**: September 10, 2025 - **Key Speaker**: Arthur T. Sands, President and CEO Core Industry and Company Insights Pipeline and Programs - Nurix is entering pivotal studies for its lead program, Bexobrutide (BexDeg), targeting chronic lymphocytic leukemia (CLL) [2] - The company is planning Phase 2 and 3 studies for BexDeg, with recent design considerations disclosed for the Phase 3 study [2][20] - Other programs include NX-2127 and NX-1607, focusing on aggressive lymphomas and immuno-oncology targets, respectively [2][3] - The company has a partnership with Sanofi for a STAT6 degrader and with Gilead for an IRAK4 degrader, both in IND-enabling studies [3][54] Platform and Technology - Nurix's platform is based on E3 ligases and has evolved to include a DEL-AI platform for ligand discovery, allowing for rapid development across oncology and inflammation [5][6] - The platform enables the development of degrader antibody conjugates (DACs), with a partnership with Pfizer [7] Safety and Efficacy of BexDeg - BexDeg has shown no drug-related atrial fibrillation above background levels, indicating a favorable cardiovascular profile compared to other BTK inhibitors [18] - The design of BexDeg aims for high selectivity and potency, which is expected to translate into better efficacy and safety [14] Pivotal Trial Design - The pivotal trial for BexDeg includes a single-arm study for accelerated approval in a third-line plus population, with a randomized control trial planned as a confirmatory study [20][21] - Key endpoints for the accelerated approval include overall response rate (ORR) and progression-free survival (PFS), with an observed ORR of about 80% in earlier trials [22][23] - The market opportunity for the third-line plus patient population is estimated to be between 8,000 to 10,000 patients in the U.S., with significant revenue potential [25] Future Aspirations - Nurix is considering combination therapies for earlier lines of treatment, with plans for a Phase 1B/2 study combining BexDeg with venetoclax and anti-CD20 antibodies [36] - The company is currently self-funding its studies but is open to partnerships for future combination studies [38] Financial Position - Nurix has a cash runway extending into the first half of 2027, with approximately $485 million in cash as of the last quarter [61] Additional Insights - The company is actively participating in upcoming medical conferences to present data on its various programs, including ESMO and ASH [42][45] - The STAT6 program with Sanofi is expected to enter healthy volunteer studies by 2026, pending Sanofi's timeline [56] This summary encapsulates the key points discussed during the conference call, highlighting Nurix Therapeutics' strategic priorities, pipeline developments, and market opportunities.

Financial Data and Key Metrics Changes - The company is focused on targeted protein degradation, a field it has been involved in for over 10 years, with a significant market opportunity exceeding $10 billion for BTK inhibitors [2][5][34] - The response rate for Bexobrutideg in heavily pretreated patients is reported at 80%, indicating a strong clinical benefit [6][19] Business Line Data and Key Metrics Changes - Bexobrutideg is the lead asset targeting BTK degradation, specifically for B-cell malignancies like CLL, with plans for phase three trials and potential accelerated approval [7][8] - The company is also developing therapies targeting STAT6 and IRAK4 in collaboration with Sanofi and Gilead, respectively, focusing on autoimmune diseases [35][38] Market Data and Key Metrics Changes - The market for CLL treatment is projected to grow significantly, with estimates of $1 billion to $2.5 billion for third-line therapy and a larger market for second-line therapy [8][34] - The company aims to capture a significant share of the current $10 billion market for BTK inhibitors through its innovative degradation approach [34] Company Strategy and Development Direction - The company is strategically moving from treating third-line patients to earlier lines of therapy, which is expected to yield higher response rates [19][34] - The focus on targeted protein degradation is positioned as a major advantage over traditional covalent and non-covalent inhibitors, aiming for a safer and more effective therapeutic profile [13][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of Bexobrutideg, noting fewer side effects compared to existing BTK inhibitors [20][21] - The company anticipates a robust news flow in the second half of the year, with multiple scientific and medical conferences planned to present data [9][39] Other Important Information - The company is preparing for pivotal trials and is in discussions with regulatory bodies regarding dosing strategies under Project Optimus [30][28] - Upcoming presentations at major conferences, including ESMO and ASH, will highlight new developments and data on Bexobrutideg and other programs [39] Q&A Session Summary Question: What are the advantages of targeted protein degradation? - The central advantage is the efficient removal of disease-causing proteins, which can lead to a comprehensive shutdown of signaling pathways [13] Question: How does the company plan to address resistance to BTK inhibitors? - The strategy involves starting with patients who have become resistant to current therapies, demonstrating the efficacy of targeted protein degradation [18][19] Question: What is the expected safety profile of Bexobrutideg? - The safety profile is expected to be superior, with on-target safety issues and improvements in blood cell counts observed [20][21] Question: How does the company select patients for clinical trials? - The company has loosened enrollment criteria, allowing for a broader patient population without specific genetic mutation requirements [26][27] Question: What are the considerations for the phase three trial design? - The trial design includes a globally relevant control arm, with a focus on proving efficacy against current standard therapies [32][34]

Nurix Therapeutics (NasdaqGM:NRIX) FY Conference September 08, 2025 01:30 PM ET Company ParticipantsArthur Sands - CEO, President & DirectorConference Call ParticipantsRobert Burns - MD & Senior Healthcare AnalystRobert BurnsHi. Welcome to our our fireside chat with NeurIX. I am Rob Perns, managing director and senior biotech analyst at HC Wainwright, and I'm joined by Arthur Sands, the CEO of NeurIX. Arthur, thank you joining us today.Arthur SandsRob, thank you for having us.Robert BurnsNo problem. So I un ...

Financial Data and Key Metrics Changes - The company reported an overall objective response rate of 80% across all patients in the trial, indicating strong efficacy of the drug [13] - The market for bexabrutinib is currently estimated at $2 billion per year, with forecasts suggesting growth to $5 billion per year [18] Business Line Data and Key Metrics Changes - Bexabrutinib is positioned as the first degrader in its category, addressing resistance mutations in BTK inhibitors, which have generated sales of approximately $9 billion to $10 billion [9][10] - The company is also developing an IRAK4 degrader in collaboration with Gilead and a STAT6 degrader with Sanofi, targeting undruggable categories with significant potential [6][48] Market Data and Key Metrics Changes - The Phase III trial will be conducted in 20 to 30 countries, enrolling 400 to 500 patients, maximizing enrollment opportunities across geographies [16] - The third-line market, where the company has generated data, is valued between $1 billion and $2.5 billion [18] Company Strategy and Development Direction - The company aims to establish bexabrutinib as a significant player in the second-line treatment market, with ambitions for first-line treatment in combination therapies [18][33] - The strategy includes a focus on both oncology and autoimmune diseases, with plans to explore multiple sclerosis and dermatology as potential areas for expansion [43][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of bexabrutinib, noting no dose-limiting toxicities or new arrhythmias observed in trials [13] - The company is optimistic about rapid enrollment in the Phase II trial due to enthusiasm from investigators and the promising results seen to date [28] Other Important Information - The company has invested over $250 million in the IRAK4 and STAT6 programs, indicating a strong commitment to these projects [48] - Future updates on the broader pipeline and other programs are expected in the fall [63] Q&A Session Summary Question: How should we think about the breakdown in terms of geography and the relevant investigator choice for the standard of care? - The company anticipates variations in treatment choices across geographies, with pirtobrutinib being primarily selected in the U.S. and Europe, while bendamustine-rituximab is more common outside these regions [20] Question: How do you think about the powering of the trial and expectations from the investigator choice arm? - The trial is powered for 400 to 500 patients, and management believes it will be well-powered to demonstrate superiority of bexabrutinib over the control arm [23] Question: What drove the decision for this trial design compared to competitors? - The design is capital efficient, allowing for a streamlined approach to achieve first approval while maintaining the potential for expansion in the future [25] Question: What are the expectations for enrollment timing for the Phase II and Phase III trials? - Enrollment for the Phase II trial is expected to take about a year, while the Phase III trial will take longer, with no specific forecast yet [28][29] Question: Is there a plan to bring in a partner to help with development costs? - The company intends to move forward independently for now, but partnerships could be considered in the future to maximize value [31] Question: How do you see differentiation between your molecules and competitors? - Differentiation will likely emerge based on safety profiles and off-target effects, which are harder to predict but crucial for long-term success [34] Question: What is the strategy for BexDeg in non-Hodgkin lymphoma and autoimmune diseases? - The company sees significant monotherapy opportunities in Waldenstrom's and plans to explore broader applications in autoimmune diseases, leveraging the advantages seen in oncology [36][39] Question: What updates can we expect for the IRAK4 and STAT6 programs? - The IRAK4 program is currently in healthy volunteer studies, while the STAT6 program has shown promising preclinical results, with both expected to advance in collaboration with Gilead and Sanofi [49][51]

Bexobrutideg Clinical Development and Market Opportunity - Bexobrutideg demonstrated an objective response rate (ORR) of 80.9% (95% CI: 66.7–90.9) in CLL response-evaluable patients in Phase 1a[18] - The median follow-up for these patients was 9.0 months (range: 1.6–26.1)[18] - The company is planning a Phase 3 monotherapy trial post-cBTKi versus standard of care, targeting 400-500 patients[21, 27] - The global market for BTK inhibitors is estimated to be over $15 billion[29] - Estimated annual BTKi sales in 2024 are ~$6B, growing to >$9B by 2028[30] - Estimated annual BTKi sales in 2024 are ~$1B, growing to >$2.5B by 2028[30] - Estimated annual BTKi sales in 2024 are ~$2B, growing to >$5B by 2028[30] Bexobrutideg's Potential and Strategy - Bexobrutideg is designed to expand and replace BTK inhibitors in the CLL market[29] - The company is pursuing an accelerated approval strategy and confirmatory study for Bexobrutideg[22] - The confirmatory Phase 3 trial will stratify by 17p del/TP53 mutation, prior BCL2i therapy, and choice of control[27] - The trial includes an investigator's choice control arm to ensure clinical relevance and maximize enrollment opportunities[28]

Group 1 - The article does not provide any specific company or industry analysis, focusing instead on the author's qualifications and disclosures [1][2][3]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(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](index=6&type=section&id=Condensed%20Balance%20Sheets) 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](index=7&type=section&id=Condensed%20Statements%20of%20Operations) 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](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) 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](index=13&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) - 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 Pfizer[32](index=32&type=chunk) - 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 months[41](index=41&type=chunk) - 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 2025[76](index=76&type=chunk)[83](index=83&type=chunk) - 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 liability[108](index=108&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=30&type=section&id=Overview) - Nurix is a clinical-stage biopharmaceutical company focused on targeted protein degradation utilizing its DEL-AI discovery engine[131](index=131&type=chunk) - The wholly-owned clinical pipeline features BTK degraders **bexobrutideg (NX-5948)** and **zelebrudomide (NX-2127)**, alongside CBL-B inhibitor **NX-1607**[131](index=131&type=chunk)[132](index=132&type=chunk)[135](index=135&type=chunk) - 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 milestones[138](index=138&type=chunk) - **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 2025[133](index=133&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) 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 Extensions[184](index=184&type=chunk) - 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 trials[185](index=185&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) - As of May 31, 2025, the company held **$485.8 million** in cash, cash equivalents, and marketable securities[196](index=196&type=chunk) - Management anticipates existing cash will be sufficient to fund operations for at least the next 12 months[197](index=197&type=chunk) - 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 extension[203](index=203&type=chunk)[204](index=204&type=chunk) - 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 financing[207](index=207&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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, 2025[208](index=208&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) 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, 2025[210](index=210&type=chunk) - No changes materially affected internal control over financial reporting during the quarter[211](index=211&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) 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 proceedings[214](index=214&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) 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](index=45&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - 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 years[216](index=216&type=chunk) - 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 termination[222](index=222&type=chunk) [Risks Related to the Discovery and Development of Our Drug Candidates](index=48&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Drug%20Candidates) - The company's lead drug candidates are in early-stage clinical development, a phase with a high risk of failure[231](index=231&type=chunk) - The targeted protein degradation platform is a novel and unproven approach, making development time, cost, and success likelihood difficult to predict[235](index=235&type=chunk) - The company faces substantial competition from major pharmaceutical and biotech companies possessing greater financial resources and expertise in R&D, manufacturing, and commercialization[261](index=261&type=chunk)[263](index=263&type=chunk) [Risks Related to Dependence on Third Parties](index=55&type=section&id=Risks%20Related%20to%20Dependence%20on%20Third%20Parties) - 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 decisions[269](index=269&type=chunk)[271](index=271&type=chunk) - Nurix relies on third-party CROs for clinical trials and CMOs for drug candidate supply, increasing risks related to quality, cost, and timeliness[276](index=276&type=chunk)[279](index=279&type=chunk) [Risks Related to Regulatory Approval and Marketing of Our Drug Candidates](index=73&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Marketing%20of%20Our%20Drug%20Candidates) - The regulatory approval process is lengthy, costly, and unpredictable, with no guarantee that any drug candidates will obtain marketing approval[346](index=346&type=chunk) - Approved products are subject to ongoing regulation, post-marketing restrictions, and potential market withdrawal if safety or efficacy issues emerge[366](index=366&type=chunk)[370](index=370&type=chunk) - Healthcare legislation, including the Inflation Reduction Act (IRA), and foreign price controls could negatively impact drug pricing and reimbursement, affecting future profitability[404](index=404&type=chunk)[406](index=406&type=chunk)[410](index=410&type=chunk) [Risks Related to Our Common Stock](index=98&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) - The company's stock price may be highly volatile due to factors like clinical trial results, regulatory developments, and market conditions[463](index=463&type=chunk) - Future sales of common stock to raise capital, including through the existing "at the market" facility, will dilute existing stockholders' ownership[467](index=467&type=chunk)[470](index=470&type=chunk) - Anti-takeover provisions in the company's charter and Delaware law could hinder beneficial acquisitions and prevent stockholders from replacing management[474](index=474&type=chunk)[475](index=475&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=105&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities[490](index=490&type=chunk) [Other Information](index=105&type=section&id=Item%205.%20Other%20Information) 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 quarter[494](index=494&type=chunk) [Exhibits](index=106&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including an amendment to a sublease agreement, officer certifications, and XBRL data files