Nurix Therapeutics(NRIX)

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Nurix Therapeutics(NRIX) - 2022 Q3 - Quarterly Report
2022-10-06 20:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended August 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39398 NURIX THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporat ...
Nurix Therapeutics(NRIX) - 2022 Q2 - Quarterly Report
2022-07-07 20:17
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended May 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39398 NURIX THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation ...
Nurix Therapeutics (NRIX) Investor Presentation - Slideshow
2022-04-14 17:49
Nurix Therapeutics Blazing a New Path in Medicine Investor Presentation April 2022 Important Notice and Disclaimers This presentation contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this presentation, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "outlook," "plan," "predict," "should," "will," and similar expre ...
Nurix Therapeutics (NRIX) Investor Presentation -Slideshow
2022-04-13 16:17
Nurix Therapeutics Blazing a New Path in Medicine Investor Presentation April 2022 Important Notice and Disclaimers This presentation contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this presentation, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "outlook," "plan," "predict," "should," "will," and similar expre ...
Nurix Therapeutics(NRIX) - 2022 Q1 - Quarterly Report
2022-04-08 20:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended February 28, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39398 NURIX THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorpor ...
Nurix Therapeutics(NRIX) - 2021 Q4 - Annual Report
2022-01-28 21:11
Washington, D.C. 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended November 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39398 NURIX THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 27-0838048 (State or other jurisdictio ...
Nurix Therapeutics (NRIX) Presents At 40th Annual J.P. Morgan Virtual Healthcare Conference
2022-01-24 19:28
| --- | --- | --- | |-------|-------|-------| | | | | | | | | | | | | Important Notice and Disclaimers This presentation contains information relating to Nurix Therapeutics, Inc. (the "Company," "we," "us" or "our") and forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations an ...
Nurix Therapeutics (NRIX) Investor Presentation - Slideshow
2021-11-23 13:23
Nurix Therapeutics Blazing a New Path in Medicine Investor Presentation Important Notice and Disclaimers This presentation contains information relating to Nurix Therapeutics, Inc. (the "Company," "we," "us" or "our") and forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations ...
Nurix Therapeutics(NRIX) - 2021 Q3 - Quarterly Report
2021-10-14 20:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended August 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39398 NURIX THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporat ...
Nurix Therapeutics(NRIX) - 2021 Q2 - Quarterly Report
2021-07-13 20:18
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Nurix Therapeutics reported collaboration revenue of **$12.1 million** and a net loss of **$50.7 million** for the six months ended May 31, 2021, with its financial position strengthened by a March 2021 equity offering resulting in **$496.5 million** in cash and investments [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of May 31, 2021, total assets increased to **$518.0 million** from **$396.3 million**, primarily due to higher cash and investments, while total liabilities rose to **$119.8 million** and stockholders' equity grew to **$398.2 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | May 31, 2021 | November 30, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $188,207 | $119,356 | | Total investments | $308,254 | $252,682 | | **Total Assets** | **$517,981** | **$396,343** | | **Liabilities & Equity** | | | | Deferred revenue (current & long-term) | $105,883 | $93,484 | | **Total Liabilities** | **$119,803** | **$106,074** | | **Total Stockholders' Equity** | **$398,178** | **$290,269** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the six months ended May 31, 2021, collaboration revenue increased to **$12.1 million**, but operating expenses more than doubled to **$63.0 million**, leading to a wider loss from operations of **$50.9 million** and a net loss of **$50.7 million** Statement of Operations Summary (in thousands) | Metric | Six Months Ended May 31, 2021 | Six Months Ended May 31, 2020 | | :--- | :--- | :--- | | Collaboration revenue | $12,102 | $7,046 | | Research and development | $48,997 | $27,109 | | General and administrative | $14,041 | $5,720 | | **Loss from operations** | **($50,936)** | **($25,783)** | | **Net income (loss)** | **($50,657)** | **($4,811)** | | Net income (loss) per share, basic | ($1.23) | ($1.32) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended May 31, 2021, net cash used in operating activities was **$23.5 million**, a shift from **$26.5 million** provided in 2020, while net cash used in investing activities increased to **$59.5 million**, and financing activities provided **$151.8 million** primarily from a stock offering Cash Flow Summary (in thousands) | Activity | Six Months Ended May 31, 2021 | Six Months Ended May 31, 2020 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | ($23,482) | $26,543 | | Net cash used in investing activities | ($59,497) | ($21,760) | | Net cash provided by financing activities | $151,830 | $119,730 | | **Net increase in cash, cash equivalents and restricted cash** | **$68,851** | **$124,513** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's biopharmaceutical business, highlighting a July 2020 IPO and March 2021 follow-on offering, ongoing collaborations with Gilead and Sanofi, **$496.5 million** in cash and investments as of May 31, 2021, and a revision to the Q2 2020 EPS calculation - In March 2021, the company completed a follow-on offering, issuing 5,175,000 shares of common stock for net proceeds of approximately **$150.1 million**[33](index=33&type=chunk) - As of May 31, 2021, the company had cash, cash equivalents, and investments of **$496.5 million** and an accumulated deficit of **$154.4 million**. Management believes current funds are sufficient for at least 12 months of operations[34](index=34&type=chunk)[35](index=35&type=chunk) - In January 2021, Sanofi exercised its option to expand the number of targets in its collaboration from three to five, paying Nurix **$22.0 million**[74](index=74&type=chunk) - The company identified an error in its Q2 2020 EPS calculation, which has been revised from **$2.03** to **$0.00** per share. Management concluded the error was not material to previously issued financial statements[121](index=121&type=chunk)[122](index=122&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's DELigase platform and lead drug candidates, noting a **$50.7 million** net loss for the first six months of fiscal 2021, with operations funded by collaborations and recent equity offerings, and **$496.5 million** in cash expected to fund operations for at least the next 12 months [Overview](index=25&type=section&id=Overview) Nurix, a biopharmaceutical company, develops small molecule therapies using its DELigase platform, with lead candidate NX-2127 in **Phase 1 clinical trial** and an accumulated deficit of **$154.4 million** as of May 31, 2021 - The company's lead drug candidate, NX-2127 (a BTK degrader), is actively recruiting for its **Phase 1 clinical trial**[126](index=126&type=chunk) - **Phase 1 trials for three other drug candidates** are expected to commence in the second half of 2021: NX-5948 (BTK degrader), NX-1607 (CBL-B inhibitor), and DeTIL-0255 (cell therapy)[126](index=126&type=chunk) Financial Summary | Metric | As of/For the Six Months Ended May 31, 2021 | | :--- | :--- | | Net Loss | $50.7 million | | Accumulated Deficit | $154.4 million | [Collaborations and License Agreements](index=26&type=section&id=Collaborations%20and%20License%20Agreements) The company's primary revenue sources are collaborations with Sanofi and Gilead, with Sanofi expanding its agreement for **$22 million** and Gilead providing **$2.5 million** in Q2 2021, potentially yielding up to **$2.5 billion** and **$2.3 billion** in future payments respectively - In January 2021, Sanofi paid **$22 million** to expand its collaboration from three to five targets[134](index=134&type=chunk)[137](index=137&type=chunk) - The company received a **$2.5 million payment** from Gilead in the second quarter of 2021 related to research milestones and other fees under their collaboration[144](index=144&type=chunk) Potential Future Collaboration Payments (as of May 31, 2021) | Collaborator | Potential Future Payments | | :--- | :--- | | Sanofi | Up to ~$2.5 billion | | Gilead | Up to ~$2.3 billion | [Results of Operations](index=29&type=section&id=Results%20of%20Operations) For the six months ended May 31, 2021, collaboration revenue increased to **$12.1 million**, while research and development expenses rose to **$49.0 million** and general and administrative expenses grew to **$14.0 million**, driven by increased activities and public company costs Collaboration Revenue (in thousands) | Collaborator | Six Months Ended May 31, 2021 | Six Months Ended May 31, 2020 | | :--- | :--- | :--- | | Gilead | $6,466 | $4,823 | | Sanofi | $5,636 | $2,223 | | **Total** | **$12,102** | **$7,046** | Research & Development Expenses Breakdown (in thousands) | Expense Category | Six Months Ended May 31, 2021 | Six Months Ended May 31, 2020 | | :--- | :--- | :--- | | Compensation and related personnel costs | $19,870 | $10,029 | | Supplies and contract research | $16,712 | $8,992 | | Clinical costs | $1,942 | $94 | | **Total R&D Expenses** | **$48,997** | **$27,109** | - The increase in G&A expenses for the six months ended May 31, 2021 was primarily due to a $5.5 million increase in compensation-related costs from higher headcount and a $2.1 million increase in professional services related to being a public company[165](index=165&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of May 31, 2021, the company had **$496.5 million** in cash and investments, primarily funded by a March 2021 follow-on offering of **$150.1 million**, with current funds expected to cover operations for at least the next 12 months, though additional long-term funding will be required - In March 2021, the company completed a follow-on offering for net proceeds of approximately **$150.1 million**[169](index=169&type=chunk) - As of May 31, 2021, the company had **$496.5 million** in cash, cash equivalents and investments, which is expected to be sufficient to fund operations for at least the next 12 months[170](index=170&type=chunk)[171](index=171&type=chunk) Cash Flow Summary - Six Months Ended May 31 (in thousands) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Operating Activities | $(23,482) | $26,543 | | Investing Activities | $(59,497) | $(21,760) | | Financing Activities | $151,830 | $119,730 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a **smaller reporting company**, Nurix is not required to provide quantitative and qualitative disclosures about market risk - As a "**smaller reporting company**," Nurix is not required to provide quantitative and qualitative disclosures about market risk[190](index=190&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were **not effective** as of May 31, 2021, due to a **material weakness** in internal control over financial reporting that led to **EPS calculation revisions**, with a **remediation plan** in progress - Management concluded that disclosure controls and procedures were **not effective** as of May 31, 2021[193](index=193&type=chunk) - The ineffectiveness is due to a previously reported **material weakness** in internal control over financial reporting, specifically a lack of formally documented controls, policies, and procedures[194](index=194&type=chunk) - This **material weakness** resulted in the **revision of basic and diluted net income (loss) per share calculations** for the three-month period ended May 31, 2020, and the three- and nine-month periods ended August 31, 2020[194](index=194&type=chunk) - The company is in the process of implementing a **remediation plan**, which includes formalizing documentation of policies and procedures[195](index=195&type=chunk)[197](index=197&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is **not currently involved in any legal proceedings that management believes would materially impact the business** or financial statements - As of the report date, the company is **not involved in any legal proceedings that management believes would materially impact the business**[199](index=199&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including substantial financial losses, early-stage drug development with an unproven platform, heavy reliance on third-party collaborations and manufacturers, intellectual property challenges, uncertain regulatory approval, market competition, and a material weakness in internal financial controls [Risks Related to Financial Position and Capital Needs](index=36&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Capital%20Needs) The company has a history of significant losses, with an accumulated deficit of **$154.4 million** as of May 31, 2021, and will require **substantial additional funding** to advance its clinical programs and for potential commercialization - The company has incurred significant losses since inception, with a net loss of **$50.7 million** for the six months ended May 31, 2021, and an accumulated deficit of **$154.4 million**[203](index=203&type=chunk) - **Substantial additional funding will be necessary** to continue operations, particularly as the company advances its drug candidates through clinical trials[209](index=209&type=chunk) [Risks Related to Discovery and Development](index=38&type=section&id=Risks%20Related%20to%20Discovery%20and%20Development) The company's **early-stage drug candidates** and **unproven targeted protein degradation platform** pose high development risks, including unpredictable success, potential adverse events, and **substantial competition** - **All drug candidates are in preclinical development or have only recently entered clinical development, carrying a high risk of failure**[218](index=218&type=chunk)[219](index=219&type=chunk) - The company's targeted protein degradation platform is an **unproven therapeutic approach**, with very few similar drug candidates having been tested in humans and none approved in the U.S. or Europe[222](index=222&type=chunk) - The company faces **substantial competition** from other companies developing protein degradation therapies, including Arvinas, C4 Therapeutics, and Kymera, as well as large pharmaceutical companies[250](index=250&type=chunk)[251](index=251&type=chunk) [Risks Related to Dependence on Third Parties](index=46&type=section&id=Risks%20Related%20to%20Dependence%20on%20Third%20Parties) Nurix is highly dependent on collaborations with Sanofi and Gilead, whose **performance and commitment are crucial**, and **relies entirely on third-party CMOs for manufacturing**, posing risks to supply, quality, cost, and regulatory compliance - The company's ability to generate revenue from its Sanofi and Gilead collaborations **depends on the collaborators' performance and their continued commitment** to the programs[257](index=257&type=chunk)[258](index=258&type=chunk) - The company **relies entirely on third-party CMOs for manufacturing**, which increases the risk of insufficient quantities, unacceptable cost or quality, and potential development or commercialization delays[268](index=268&type=chunk) [Risks Related to Intellectual Property](index=51&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's success depends on obtaining and maintaining patent protection for its **early-stage portfolio**, facing risks of infringement claims from third parties in a crowded field, including a **specific patent that may cover its CTM drug candidates like NX-2127** - The company's **patent portfolio is at an early stage** and consists only of patent applications; there is no guarantee that issued patents will be obtained to cover its drug candidates[293](index=293&type=chunk) - **A third-party patent exists with a claim that could be alleged to cover one or more of the company's CTM drug candidates, including NX-2127**, potentially requiring a license or forcing a halt to development[310](index=310&type=chunk) - The company may be subject to claims that its employees have **misappropriated trade secrets from former employers**, which could lead to litigation and loss of valuable intellectual property[318](index=318&type=chunk) [Risks Related to Regulatory Approval and Other Legal Matters](index=59&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Matters) The company faces a **lengthy, unpredictable, and expensive regulatory approval process** with no guarantee of marketing approval, ongoing regulatory burdens, pricing challenges, **stringent data privacy and anti-corruption laws**, and potential disruptions from the **COVID-19 pandemic** - The **FDA regulatory approval process is lengthy and unpredictable**, and there is no guarantee that any of the company's drug candidates will ever obtain marketing approval[333](index=333&type=chunk)[334](index=334&type=chunk) - The company may seek approval for its drug candidates under the FDA's **Accelerated Approval Pathway**, which, even if granted, requires confirmatory post-marketing trials that could fail, leading to a withdrawal of the approval[339](index=339&type=chunk)[343](index=343&type=chunk) - The ongoing **COVID-19 pandemic could disrupt the supply chain**, delay clinical trials, and adversely affect the company's ability to obtain regulatory approvals[389](index=389&type=chunk) - The company is subject to **complex and evolving data privacy laws**, such as the EU's GDPR and California's CCPA/CPRA, and failure to comply could result in significant fines and reputational harm[405](index=405&type=chunk)[407](index=407&type=chunk)[410](index=410&type=chunk) [Risks Related to Common Stock](index=77&type=section&id=Risks%20Related%20to%20Common%20Stock) The company's stock price may be volatile due to clinical and regulatory developments, a **material weakness in internal financial controls**, reduced reporting requirements as an "**emerging growth company**," and **no anticipated dividends** - A **material weakness in internal control over financial reporting was identified and has not been remediated** as of May 31, 2021. This could result in a material misstatement of financial statements[459](index=459&type=chunk) - The company is an "**emerging growth company**" and has elected to use the extended transition period for adopting new accounting standards, which may make its financial statements not comparable to other public companies[447](index=447&type=chunk)[448](index=448&type=chunk) - The company does **not anticipate paying any cash dividends** in the foreseeable future; capital appreciation is the sole expected source of gain for investors[461](index=461&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=83&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports **no material change in the planned use of proceeds** from its IPO and no unregistered sales of equity securities during the period - The company confirms **no material change in the planned use of proceeds** from its July 2020 IPO[464](index=464&type=chunk)