Nurix Therapeutics(NRIX)
Search documents
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)
Nurix Therapeutics (NRIX) Investor Presentation - Slideshow
2021-04-15 19:46
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 Q1 - Quarterly Report
2021-04-13 20:24
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, 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 incorpor ...
Nurix Therapeutics (NRIX) Investor Presentation - Slideshow
2021-03-18 19:48
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) - 2020 Q4 - Annual Report
2021-02-16 21:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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, 2020 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 ...