Nurix Therapeutics(NRIX) - 2021 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements 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 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 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 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 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] - 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][35] - 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] - 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][122] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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] - 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] 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 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][137] - 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] 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 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] Liquidity and Capital Resources 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] - 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][171] 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 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] Item 4. Controls and Procedures 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] - 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] - 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] - The company is in the process of implementing a remediation plan, which includes formalizing documentation of policies and procedures[195][197] PART II. OTHER INFORMATION Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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 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] - Substantial additional funding will be necessary to continue operations, particularly as the company advances its drug candidates through clinical trials[209] Risks Related to Discovery and Development 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][219] - 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] - 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][251] Risks Related to Dependence on Third Parties 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][258] - 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] Risks Related to Intellectual Property 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] - 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] - 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] Risks Related to Regulatory Approval and Other Legal Matters 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][334] - 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][343] - 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] - 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][407][410] Risks Related to Common Stock 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] - 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][448] - 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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]