Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID 238 )
127
Consolidated Balance Sheets
129
Consolidated Statements of Operations
130
Consolidated Statements of Comprehensive Loss
131
Consolidated Statements of Stockholders’ Equity
132
Consolidated Statements of Cash Flows
133
Notes to Consolidated Financial Statements
134
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Nurix Therapeutics, Inc.
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying 2024 financial statements of Nurix Therapeutics, Inc. and the 2023 consolidated financial statements of Nurix Therapeutics, Inc. and its subsidiary (collectively referred to as the “Company”), which comprise the balance sheets as of November 30, 2024 and 2023, and the related statements of operations, of comprehensive loss, of stockholders’ equity and of cash flows for each of the three years in the period ended November 30, 2024, including the related notes (collectively referred to as the "financial statements"). We also have audited the Company's internal control over financial reporting as of November 30, 2024, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of November 30, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended November 30, 2024 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of November 30, 2024, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Company's management is responsible for these financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the Company’s financial statements and on the Company's internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the financial statements included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Emphasis of Matter
As discussed in Note 1 to the financial statements, the Company will need substantial additional funding to support its continuing operations and pursue its long-term business plan. Management's evaluation of the events and conditions related to this matter are also described in Note 1.
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Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Revenue Recognition - Estimated Costs of Internal Full-Time Employees (FTEs) - Pfizer Collaboration Agreement
As described in Notes 2 and 3 to the financial statements, the Company’s collaboration revenue was $54.5 million for the year ended November 30, 2024, of which revenue of $18.8 million was recognized related to the Company’s collaboration agreement with Pfizer. The Company enters into collaboration agreements and assesses those agreements to determine the performance obligations. Management uses a cost-based input method, which the Company determined most faithfully depicts the transfer of its performance obligation to Pfizer, to recognize revenue based on the actual costs incurred as a percentage of total estimated costs as the Company completes its performance obligation under the contract. Costs consist primarily of internal FTE and third-party contract costs related to the Pfizer agreement. The cumulative effect of revisions to estimated costs to complete the Company’s performance obligation is recorded in the period in which changes are identified and amounts can be reasonably estimated. Total estimated costs are primarily driven by the number of estimated FTEs, which requires significant management judgment.
The principal considerations for our determination that performing procedures relating to revenue recognition - estimated costs of internal FTEs relating to the Pfizer collaboration agreement is a critical audit matter are (i) the significant judgment by management when developing the estimated costs of internal FTEs and (ii) a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating management’s significant assumption related to the number of estimated FTEs.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial statements. These procedures included testing the effectiveness of controls relating to the revenue recognition process, including controls over the development of the estimated costs of internal FTEs. These procedures also included, among others, evaluating and testing management’s process for developing the estimated costs of internal FTEs, which included evaluating the reasonableness of the significant assumption related to the number of estimated FTEs. Evaluating management’s estimated costs of internal FTEs involved (i) performing a comparison of management’s estimated costs of internal FTEs to the actual internal FTE costs; (ii) testing the completeness and accuracy of the data used by management in the estimate; (iii) evaluating management’s timely identification of changes in estimated costs of internal FTEs; and (iv) evaluating whether the estimate and assumption were consistent with evidence obtained in other areas of the audit.
/s/ PricewaterhouseCoopers LLP
San Jose, California
January 28, 2025
We have served as the Company’s auditor since 2014.
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NURIX THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
November 30,
2024 2023
Assets
Current assets:
Cash and cash equivalents $ 109,997 $ 54,627
Marketable securities, current 499,586 233,281
Prepaid expenses and other current assets 9,804 7,595
Total current assets 619,387 295,503
Marketable securities, non-current — 7,421
Operating lease right-of-use assets 28,139 31,142
Property and equipment, net 17,757 16,808
Restricted cash 901 901
Other assets 3,159 3,823
Total assets $ 669,343 $ 355,598
Liabilities and stockholdersʼ equity
Current liabilities:
Accounts payable $ 11,482 $ 6,401
Accrued expenses and other current liabilities 37,994 24,970
Operating lease liabilities, current 8,014 7,489
Deferred revenue, current 38,364 48,098
Total current liabilities 95,854 86,958
Operating lease liabilities, net of current portion 20,289 23,125
Deferred revenue, net of current portion 26,207 45,022
Total liabilities 142,350 155,105
Commitments and contingencies (Note 6)
Stockholders’ equity:
Preferred stock, $ 0.001 par value— 10,000,000 shares authorized as of November 30, 2024 and 2023; no shares issued and outstanding as of November 30, 2024 and 2023
— —
Common stock, $ 0.001 par value— 500,000,000 shares authorized as of November 30, 2024 and 2023; 75,870,718 and 48,718,552 shares issued and outstanding as of November 30, 2024 and 2023, respectively
76 49
Additional paid-in capital 1,265,536 746,299
Accumulated other comprehensive income (loss) 150 ( 655 )
Accumulated deficit ( 738,769 ) ( 545,200 )
Total stockholders’ equity 526,993 200,493
Total liabilities and stockholders’ equity $ 669,343 $ 355,598
The accompanying notes are an integral part of these consolidated financial statements.
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NURIX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
Year Ended November 30,
2024 2023 2022
Revenue:
Collaboration revenue $ 54,549 $ 56,987 $ 38,627
License revenue — 20,000 —
Total revenue 54,549 76,987 38,627
Operating expenses:
Research and development 221,632 189,148 184,497
General and administrative 45,944 42,902 37,997
Total operating expenses 267,576 232,050 222,494
Loss from operations ( 213,027 ) ( 155,063 ) ( 183,867 )
Interest and other income, net 19,728 11,115 3,507
Loss before income taxes ( 193,299 ) ( 143,948 ) $ ( 180,360 )
Provision for income taxes 270 — —
Net loss $ ( 193,569 ) $ ( 143,948 ) $ ( 180,360 )
Net loss per share, basic and diluted $ ( 2.88 ) $ ( 2.65 ) $ ( 3.71 )
Weighted-average number of shares outstanding, basic and diluted 67,120,266 54,337,901 48,607,990
The accompanying notes are an integral part of these consolidated financial statements.
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NURIX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Year Ended November 30,
2024 2023 2022
Net loss $ ( 193,569 ) $ ( 143,948 ) $ ( 180,360 )
Other comprehensive loss, net of tax:
Unrealized gain (loss) on available-for-sale marketable securities 805 3,664 ( 3,711 )
Total comprehensive loss $ ( 192,764 ) $ ( 140,284 ) $ ( 184,071 )
The accompanying notes are an integral part of these consolidated financial statements.
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NURIX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
Common stock Additional
paid-in
capital Accumulated
other
comprehensive
income (loss) Accumulated
deficit Total
stockholders’
equity
Shares Amount
Balance as of November 30, 2021 44,664,371 $ 45 $ 563,757 $ ( 608 ) $ ( 220,892 ) $ 342,302
Issuance of pre-funded warrants, net of issuance costs of $ 234
— — 94,759 — — 94,759
Issuance of common stock in "at the market" financing, net of issuance costs of $ 672
2,000,000 2 19,326 — — 19,328
Exercise of stock options 325,596 — 1,078 — — 1,078
Vesting of restricted stock units 46,028 — — — — —
Vesting of early exercised stock options — — 145 — — 145
Issuance under employee stock purchase plan 136,304 — 1,955 — — 1,955
Stock-based compensation — — 28,200 — — 28,200
Unrealized loss on available-for-sale marketable securities — — — ( 3,711 ) — ( 3,711 )
Net loss — — — — ( 180,360 ) ( 180,360 )
Balance as of November 30, 2022 47,172,299 47 709,220 ( 4,319 ) ( 401,252 ) 303,696
Exercise of pre-funded warrants 717,360 2 — — — 2
Exercise of stock options 120,826 — 986 — — 986
Vesting of restricted stock units 441,103 — — — — —
Vesting of early exercised stock options — — 117 — — 117
Issuance under employee stock purchase plan 266,964 — 2,229 — — 2,229
Stock-based compensation — — 33,747 — — 33,747
Unrealized gain on available-for-sale marketable securities — — — 3,664 — 3,664
Net loss — — — — ( 143,948 ) ( 143,948 )
Balance as of November 30, 2023 48,718,552 $ 49 $ 746,299 $ ( 655 ) $ ( 545,200 ) $ 200,493
Issuance of common stock and pre-funded warrants, net of issuance costs of $ 12,518
11,916,667 12 188,720 — — 188,732
Issuance of common stock in "at the market" financing, net of issuance costs of $ 6,186
13,777,775 14 289,355 — — 289,369
Exercise of pre-funded warrants 19,750 — — — — —
Exercise of stock options 508,648 1 5,054 — — 5,055
Vesting of restricted stock units 654,396 — — — — —
Vesting of early exercised stock options — — 33 — — 33
Repurchase of unvested early exercised stock ( 1,548 ) — — — — —
Issuance under employee stock purchase plan 276,478 — 2,132 — — 2,132
Stock-based compensation — — 33,943 — — 33,943
Unrealized gain on available-for-sale marketable securities — — — 805 — 805
Net loss — — — — ( 193,569 ) ( 193,569 )
Balance as of November 30, 2024 75,870,718 $ 76 $ 1,265,536 $ 150 $ ( 738,769 ) $ 526,993
The accompanying notes are an integral part of these consolidated financial statements.
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NURIX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended November 30,
2024 2023 2022
Cash flows from operating activities
Net loss $ ( 193,569 ) $ ( 143,948 ) $ ( 180,360 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 9,318 7,533 5,349
Stock-based compensation 33,929 33,673 28,131
Net amortization (accretion) of premium (discount) on marketable securities ( 11,288 ) ( 5,421 ) 426
Loss on disposal of property and equipment 31 556 9
Amortization of operating lease right-of-use assets 7,110 6,121 5,459
Other 286 — 201
Changes in operating assets and liabilities:
Accounts receivable — — 6,000
Prepaid expenses and other assets ( 459 ) 2,139 ( 1,094 )
Accounts payable 5,209 1,614 85
Deferred revenue ( 28,549 ) 19,513 ( 26,627 )
Operating lease liabilities ( 6,418 ) ( 6,268 ) ( 4,871 )
Accrued expenses and other current liabilities 11,816 3,123 7,485
Net cash used in operating activities ( 172,584 ) ( 81,365 ) ( 159,807 )
Cash flows from investing activities
Purchases of marketable securities ( 707,953 ) ( 246,334 ) ( 239,366 )
Maturities of marketable securities 459,513 323,036 278,808
Purchases of property and equipment ( 9,273 ) ( 8,401 ) ( 12,244 )
Net cash (used in) provided by investing activities ( 257,713 ) 68,301 27,198
Cash flows from financing activities
Proceeds from issuances of common stock and pre-funded warrants in equity financing, net of issuance costs 188,732 — 94,759
Proceeds from issuances of common stock in "at the market" financing, net of issuance costs 289,763 — 19,400
Proceeds from exercise of stock options and pre-funded warrants 5,055 988 1,078
Proceeds from issuance under employee stock purchase plan 2,132 2,229 1,955
Repurchase of unvested early exercised stock options ( 15 ) — —
Net cash provided by financing activities 485,667 3,217 117,192
Net increase (decrease) in cash, cash equivalents and restricted cash 55,370 ( 9,847 ) ( 15,417 )
Cash, cash equivalents and restricted cash at beginning of period 55,528 65,375 80,792
Cash, cash equivalents and restricted cash at end of period $ 110,898 $ 55,528 $ 65,375
Supplemental disclosures of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable and accrued expenses and other current liabilities $ 1,643 $ 632 $ 1,373
Right-of-use assets recognized in exchange for lease obligations $ 4,107 $ 23,995 $ 5,068
Capitalized stock-based compensation related to internal-use software development
$ 14 $ 74 $ 69
Deferred issuance costs included in accounts payable and accrued expenses and other current liabilities $ 117 $ — $ —
Deferred issuance costs recognized related to the "at the market" financing $ 394 $ — $ 72
Vesting of early exercised stock options $ 33 $ 117 $ 145
As of November 30,
2024 2023 2022
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents $ 109,997 $ 54,627 $ 64,474
Restricted cash 901 901 901
Total cash, cash equivalents and restricted cash $ 110,898 $ 55,528 $ 65,375
The accompanying notes are an integral part of these consolidated financial statements.
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NURIX THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Organization
Description of Business
Nurix Therapeutics, Inc. (the Company) was incorporated in the state of Delaware on August 27, 2009, and is headquartered in San Francisco, California. The Company is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative small molecules and antibody therapies based on the degradation of cellular protein levels as a novel treatment approach for cancer, inflammatory conditions and other challenging diseases. Leveraging the Company’s expertise in E3 ligases together with its proprietary DNA-encoded libraries, the Company has built DEL-AI, a fully AI-integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can degrade proteins within the cell. The Company’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. The Company’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. The Company’s partnered drug discovery pipeline consists of multiple programs under collaboration agreements with Gilead Sciences, Inc. (Gilead), Sanofi S.A. (Sanofi) and Seagen Inc. (now a part of Pfizer Inc. (Pfizer)), within which the Company retains certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates.
Equity Distribution Agreement
In August 2021, the Company filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC), which was amended in February 2023 (the Shelf Registration Statement) and which expired in August 2024 with respect to additional sales of securities. The Shelf Registration Statement, which included a base prospectus, allowed the Company to offer and sell up to $ 450.0 million of the Company’s registered common stock, preferred stock, debt securities, warrants, subscriptions rights and/or units or any combination of securities described in the prospectus in one or more offerings. In addition, in August 2021, the Company entered into an Equity Distribution Agreement with Piper Sandler & Co. (Piper Sandler) pursuant to which, from time to time, the Company could offer and sell through Piper Sandler up to $ 150.0 million of the common stock registered under the Shelf Registration Statement pursuant to one or more “at the market” offerings.
The Company was not required to sell any shares at any time during the term of the Equity Distribution Agreement. The Company agreed to pay Piper Sandler a commission of 3.0 % of the gross sales price of any shares sold pursuant to the Equity Distribution Agreement. In June 2022, the Company issued and sold 2,000,000 shares of common stock under the Equity Distribution Agreement at a price of $ 10.00 per share for net proceeds of $ 19.3 million after deducting offering commissions and expenses paid by the Company. In May 2024, the Company issued and sold 3,194,809 shares of common stock under the Equity Distribution Agreement at various prices ranging from $ 15.50 to $ 16.00 per share for total net proceeds of $ 48.5 million, after deducting offering commissions and expenses paid by the Company.
In June 2024, the Company filed an automatic shelf registration statement on Form S-3 (the Automatic Shelf Registration Statement). The Automatic Shelf Registration Statement, which includes a base prospectus, allows the Company at any time to offer and sell the Company’s registered common stock, preferred stock, debt securities, warrants, subscriptions rights and/or units or any combination of securities described in the prospectus in one or more offerings. On July 11, 2024, the Company entered into Amendment No. 1 to the Equity Distribution Agreement (as amended, the Amended Equity Distribution Agreement), pursuant to which, from time to time, the Company may offer and sell through Piper Sandler up to $ 150.0 million of common stock registered under the Automatic Shelf Registration Statement pursuant to one or more “at the market” offerings.
The Company was not required to sell any shares at any time during the term of the Amended Equity Distribution Agreement. The Company agreed to pay Piper Sandler a commission of up to 3 % of the gross sales price of any shares sold pursuant to the Amended Equity Distribution Agreement. In August 2024, the Company issued and sold 2,145,000 shares of common stock under the Amended Equity Distribution Agreement at a price of $ 20.00 per share for total net proceeds of $ 42.0 million, after deducting offering commissions and expenses paid by the Company. In October 2024, the Company issued and sold 4,803,573 shares of common stock under the Amended Equity Distribution Agreement at various prices ranging from $ 21.50 to $ 25.00 per share for total net proceeds of $ 105.3 million, after deducting offering commissions and expenses paid by the Company.
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On October 31, 2024, the Company entered into Amendment No. 2 to the Equity Distribution Agreement (as amended, the Second Amended Equity Distribution Agreement), pursuant to which, from time to time, the Company may offer and sell through Piper Sandler up to $ 300.0 million of common stock registered under the Automatic Shelf Registration Statement pursuant to one or more “at the market” offerings. The Company is not required to sell any shares at any time during the term of the Second Amended Equity Distribution Agreement. The Company agreed to pay Piper Sandler a commission of up to 3 % of the gross sales price of any shares sold pursuant to the Second Amended Equity Distribution Agreement. In November 2024, the Company issued and sold 3,634,393 shares of common stock under the Second Amended Equity Distribution Agreement at a price of $ 26.25 per share for total net proceeds of $ 93.6 million, after deducting offering commissions and expenses paid by the Company. As of November 30, 2024, the Company had $ 204.6 million of common stock remaining available for sale under the Second Amended Equity Distribution Agreement.
Registered Direct Offerings
In July 2022, the Company entered into separate securities purchase agreements with certain purchasers to issue and sell pre‑funded warrants to purchase an aggregate of 6,814,920 shares of the Company’s common stock in registered direct offerings (RDOs) at a price of $ 13.939 per pre-funded warrant (the 2022 Pre-Funded Warrants). Net proceeds from the RDOs were $ 94.8 million, after deducting offering expenses of $ 0.2 million. Refer to Note 7 for more information regarding the 2022 Pre-Funded Warrants.
Public Offering
In April 2024, the Company completed a public offering (2024 Public Offering) pursuant to the Shelf Registration Statement and issued 11,916,667 shares of common stock (including the exercise by the underwriters of their option to purchase an additional 1,750,000 shares of common stock) at a price to the public of $ 15.00 per share, and pre-funded warrants to purchase an aggregate of 1,500,100 shares of the Company’s common stock at a price of $ 14.999 per pre-funded warrant (the 2024 Pre-Funded Warrants). Net proceeds from the 2024 Public Offering were approximately $ 188.7 million, after deducting offering commissions and expenses of $ 12.5 million. Refer to Note 7 for more information regarding the 2024 Pre-Funded Warrants.
Liquidity and Management Plans
The Company’s operations have historically been financed through the issuance of common stock, redeemable convertible preferred stock and pre-funded warrants and proceeds received under the Company’s collaboration and license agreements. Since inception, the Company has generally incurred significant losses and negative net cash flows from operations. The Company does not expect its existing cash, cash equivalents and marketable securities to be sufficient to fund the completion of its clinical trials through commercialization and will need substantial additional funding to support its continuing operations and pursue its long-term business plan. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its drug candidates currently in development.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As of November 30, 2024, the Company had cash, cash equivalents and short-term marketable securities of $ 609.6 million, working capital of $ 523.5 million and an accumulated deficit of $ 738.8 million. Management believes that its cash, cash equivalents and short-term marketable securities are sufficient to continue operating activities for at least 12 months following the issuance date of these consolidated financial statements. Future capital requirements will depend on many factors, including the timing and extent of spending on research and development and payments the Company may receive under its collaboration agreements with Sanofi, Gilead and Pfizer or future collaboration agreements, if any. There can be no assurance that, in the event the Company requires additional financing, such financing will be available at terms acceptable to the Company if at all. If additional capital is not available, failure to generate sufficient cash flows from operations, raise additional capital and reduce discretionary spending could have a material adverse effect on the Company’s ability to achieve its intended business objectives. Management considered whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern and evaluated the funds necessary to maintain operations. Based on the Company’s current forecast of future operating results, the Company has concluded that its cash, cash equivalents and short-term marketable securities are sufficient to continue operating activities for at least 12 months following the issuance date of these consolidated financial statements.
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2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Company’s consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and include the accounts of the Company and its wholly owned subsidiaries, including DeCART Therapeutics Inc., which was legally dissolved in July 2022. All intercompany balances and transactions have been eliminated in consolidation. As of November 30, 2024, the Company has no remaining subsidiaries.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to the useful lives of long-lived assets, the measurement of stock-based compensation, accruals for research and development activities, income taxes and revenue recognition. The Company also makes certain commencement date estimates for its leases, including the incremental borrowing rate, the expected lease term and the fair value of the leased asset. The Company bases its estimates on historical experience and on other relevant assumptions that are reasonable under the circumstances. Actual results could materially differ from those estimates. Refer to Note 3 for more information regarding the estimates related to revenue recognition.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities. The Company’s marketable securities consist of debt securities issued by highly rated corporate entities, the U.S. federal government or state and local governments. The Company’s exposure to any individual corporate entity is limited by policy. Deposits may, at times, exceed federally insured limits. The Company invests its cash equivalents in highly rated money market funds. During the periods presented, the Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities.
Other Risks and Uncertainties
The Company is subject to a number of risks similar to other clinical stage biopharmaceutical companies, including, but not limited to, changes in any of the following areas that the Company believes could have a material adverse effect on its future financial position or results of operations: risks related to the successful discovery and development of its drug candidates, ability to raise additional capital, development of new technological innovations by its competitors and delay or inability to obtain drug substance and finished drug product from the Company’s third-party contract manufacturers necessary for the Company’s drug candidates, protection of intellectual property rights, litigation or claims against the Company based on intellectual property rights and regulatory clearance and market acceptance for any of the Company’s products candidates for which the Company receives marketing approval.
Moreover, the Company is subject to risks and uncertainties as a result of global business, political and macroeconomic events and conditions, including increasing financial market volatility and uncertainty, inflation, interest rate fluctuations, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, potential instability in the global banking system, cybersecurity events, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics. The extent to which business, political and macroeconomic factors, including increasing financial market volatility and uncertainty, will impact the Company’s business will depend on future developments that are highly uncertain and cannot be predicted at this time.
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The extent to which the increasing financial market volatility and uncertainty may directly or indirectly impact the consolidated financial statements is highly uncertain and subject to change.
The Company relies on single source manufacturers and suppliers for the supply of its drug candidates. Disruption from these manufacturers or suppliers would have a negative impact on the Company’s business, financial position and results of operations.
Segments
The Company operates and manages its business as one reportable and operating segment. Operating segments are defined as components of an enterprise where separate financial information is evaluated regularly by the chief operating decision maker (CODM) in deciding how to allocate resources and assess performance. The Company’s CODM is the Chief Executive Officer, who reviews consolidated financial information on a company-wide basis for purposes of allocating resources and assessing financial performance.
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Cash and Cash Equivalents
The Company considers all highly liquid marketable securities with a maturity of three months or less when purchased to be cash equivalents. Cash equivalents, which consist of money market funds, are stated at fair value.
Restricted Cash
The Company had $ 0.9 million of restricted cash recorded as a non-current asset as of each of November 30, 2024 and 2023. Restricted cash as of each of November 30, 2024 and 2023 consisted of $ 0.1 million that serves as collateral for a business credit card account and $ 0.8 million for letters of credit required under operating leases. These balances are included within the cash, cash equivalents and restricted cash balance in the accompanying consolidated statements of cash flows and separately presented as such in the consolidated balance sheets.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, including cash equivalents, accounts payable and accrued liabilities included in the consolidated financial statements approximate their fair value due to the nature of the financial instruments. Refer to Note 5 for more information regarding the fair value of the Company’s marketable securities.
Marketable Securities
Marketable securities consist of money market funds, U.S. Treasuries, corporate debt securities and U.S. government agency securities. The Company’s marketable securities are classified as available-for-sale and carried at estimated fair values and reported in cash equivalents, short-term marketable securities or long-term marketable securities. Management determines the appropriate classification of the marketable securities at the time they are acquired and evaluates the appropriateness of such classifications at each consolidated balance sheet date. Marketable securities with contractual maturities greater than 12 months are considered long-term marketable securities.
The Company regularly reviews its marketable securities for declines in estimated fair value below amortized cost. The factors considered in determining whether a credit loss exists include the creditworthiness of the security issuers, the number of marketable securities in an unrealized loss position, the severity and duration of the unrealized losses, and whether it is more likely than not that the Company will be required to sell the marketable securities before the recovery of their amortized cost basis. The cost of marketable securities sold is based on the specific identification method. In circumstances when an unrealized loss is determined to be credit-related, or when the Company intends to sell or is more likely than not required to sell a security before it recovers its amortized cost basis, the difference between the fair value and the amortized cost of the security is recognized as interest and other income, net in the consolidated statements of operations, and an allowance for credit loss is recorded on the consolidated balance sheet. In circumstances when the decline in fair value is non-credit related, the difference is reported in accumulated other comprehensive income (loss), net of tax as a separate component of stockholders’ equity.
The Company excludes accrued interest from both the fair value and the amortized cost basis of marketable securities for the purposes of identifying and measuring an impairment. The Company writes off accrued interest receivables that have become more than 90 days delinquent by reversing interest income. To date, the Company has not written off any accrued interest receivables associated with its marketable securities.
Property and Equipment
Property and equipment are stated at cost, net of accumulated depreciation and amortization. Major improvements are capitalized, while maintenance and repairs are expensed when incurred. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. The useful life of laboratory equipment, computer equipment, furniture and fixtures and software is generally three years . Tenant improvements are depreciated over the shorter of the lease term or the estimated useful life of the improvements. When assets are retired or disposed of, the cost together with related accumulated depreciation is removed from the Company’s accounts and the resulting gain or loss is reflected in the consolidated statements of operations.
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Leases
The Company determines if an arrangement contains a lease and the classification of the lease at inception. An arrangement contains a lease if there is an identified asset and if the Company controls the use of the identified asset throughout the period of use. The evaluation of whether the lease is an operating or a finance lease requires judgments in determining the fair value of the leased asset. Lease right-of-use (ROU) assets and lease liabilities are recognized at the lease commencement date based on the present value of the future minimum lease payments over the lease term at the commencement date. ROU assets also include any initial direct costs incurred and any lease payments made on or before the lease commencement date, less any lease incentives received. The Company uses its incremental borrowing rate, if an implicit rate is not readily available, and the information available at the date of lease commencement in determining its lease liabilities. The Company’s incremental borrowing rate is based on the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment, and the determination of the rate requires the Company to make certain assumptions and judgements, including on its synthetic credit rating. Leases may include options to extend or early terminate the lease term. If the Company, using judgement, is reasonably certain that an option will be exercised, then the option will be included in the calculation of the lease term. The Company elected to combine lease and non-lease components for all underlying assets groups, and not recognize ROU assets or lease liabilities for short-term leases. A short-term lease is a lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company does not have any finance leases.
Internal-Use Software Development Costs
The Company capitalizes qualifying costs incurred during the application development stage related to software developed for internal-use and amortizes them over the estimated useful life of three years . Amortization of such costs begins when the project is substantially complete and ready for its intended use. Capitalized software development costs are classified as property and equipment, net on the consolidated balance sheet. The Company expenses costs incurred related to the planning and post-implementation phases of development as incurred.
Impairment of Long-Lived Assets
Long-lived assets, such as property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable. If circumstances require a long-lived asset or asset group to be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. There were no such impairment losses during the years ended November 30, 2024, 2023 and 2022.
Deferred Offering Costs
The Company capitalizes within other assets certain legal, accounting and other third-party fees that are directly related to the Company’s in-process equity financings until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should a planned equity financing be abandoned, terminated or significantly delayed, the deferred offering costs are immediately written off to operating expenses. As of November 30, 2024 and 2023, there was $ 0.1 million and $ 0.5 million, respectively, of deferred offering costs included in other assets on the consolidated balance sheet.
Revenue Recognition
The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To recognize revenue from a contract with a customer, the Company performs the following five steps:
(i) identify the contract(s) with a customer;
(ii) identify the performance obligations in the contract;
(iii) determine the transaction price;
(iv) allocate the transaction price to the performance obligations in the contract; and
(v) recognize revenue when (or as) the Company satisfies a performance obligation.
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At contract inception, the Company assesses the goods or services promised within each contract, whether each promised good or service is distinct, and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied.
The Company enters into collaboration agreements under which it may obtain upfront payments, milestone payments, royalty payments and other fees. Promises under these arrangements may include research licenses, research services, including selection campaign research services for certain replacement targets, the obligation to share information during the research and the participation of alliance managers and in joint research committees, joint patent committees and joint steering committees. The Company assesses these promises within the context of the agreements to determine the performance obligations.
Exclusive license rights : If a license to the Company’s intellectual property is determined to be distinct from the other promises identified in the arrangement, the Company recognizes revenue from nonrefundable, upfront payments allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license and the underlying intellectual property. If the license is the predominant promise, and it is determined that the license represents functional intellectual property, revenue is recognized at the point in time when control of the license is transferred. If it is determined that the license does not represent functional intellectual property, revenue is recognized over time using an appropriate method of measuring progress.
Research and collaboration licenses : Collaboration agreements may include research licenses and research and development services to be performed by the Company. For research licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring proportional performance for purposes of recognizing revenue from non-refundable, upfront payments. The Company evaluates the measure of proportional performance each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone payments : At the inception of each arrangement that includes research, development or regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. The Company uses the most likely amount method for research, development and regulatory milestone payments. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. If it is probable that a significant revenue reversal would not occur, the associated milestone amount is included in the transaction price.
Sales-based milestones and royalties : For arrangements that include sales-based milestone or royalty payments based on the level of sales, and in which the license is deemed to be the predominant item to which the sales-based milestone or royalties relate to, the Company recognizes revenue in the period in which the sales-based milestone is achieved and in the period in which the sales associated with the royalty occur. To date, the Company has not recognized any sales-based milestone or royalty revenue resulting from its collaboration arrangements.
Customer options : Customer options, such as options granted to allow a licensee to extend a license or research term, to select additional research targets or to choose to research, develop and commercialize licensed compounds are evaluated at contract inception to determine whether those options provide a material right (i.e., an optional good or service offered for free or at a discount) to the customer. If the customer options represent a material right, the material right is treated as a separate performance obligation at the outset of the arrangement. The Company allocates the transaction price to material rights based on the standalone selling price. As a practical alternative to estimating the standalone selling price of a material right when the underlying goods or services are both (i) similar to the original goods or services in the contract and (ii) provided in accordance with the terms of the original contract, the Company allocates the total amount of consideration expected to be received from the customer to the total goods or services expected to be provided to the customer. Amounts allocated to any material right are recognized as revenue when or as the related future goods or services are transferred or when the option expires. If the option does not provide a material right, then the option is considered a marketing offer, which would be accounted for as a separate contract upon exercise.
Deferred revenue, which is a contract liability, represents net amounts received by the Company for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the consolidated balance sheet date based on the estimated performance period of the underlying performance obligation. The non-current portion of deferred revenue represents amounts to be recognized after one year through the end of the performance period of the performance obligation.
All revenue was derived from customers located in the United States during the years ended November 30, 2024, 2023 and 2022.
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Research and Development Expenses
The Company expenses all research and development costs as incurred. Research and development costs include, but are not limited to, payroll and personnel expenses, laboratory supplies, preclinical study costs, clinical trial costs, compound manufacturing costs, consulting costs and allocated overhead, including rent, equipment, depreciation and utilities.
The Company records accrued expenses for estimated costs of research and development activities conducted by third-party service providers, which include preclinical studies and clinical trials and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued expenses and other current liabilities on the consolidated balance sheet.
The Company estimates the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. The Company makes significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, the Company adjusts its accrued estimates. The Company’s accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from clinical research organizations and other third-party service providers. The Company records advance payments to service providers as prepaid assets, which are expensed as the contracted services are performed.
Stock-Based Compensation
The Company accounts for stock-based compensation using a fair value-based method, which requires the recognition of compensation expense for costs related to all stock-based payments including stock options, restricted stock units (RSUs) and purchase rights under the Company’s 2020 Employee Stock Purchase Plan (ESPP). The Company estimates the fair value of stock options and purchase rights granted under the ESPP on the date of grant using the Black-Scholes option pricing model, which is impacted by the fair value of the Company’s common stock, as well as changes in assumptions regarding a number of highly complex and subjective variables. The model requires management to make a number of assumptions including expected volatility, expected term, risk-free interest rate and expected dividend yield. The Company determines the fair value of stock options, RSUs and purchase rights under the ESPP using the market closing price of the Company’s common stock on the date of grant.
For stock-based payments with service conditions only, the Company uses the straight-line method to allocate compensation cost to reporting periods over the requisite service period, which is generally the vesting period. Stock-based compensation expense for non-employee stock-based awards is also measured based on the grant date fair value with the estimated fair value expensed over the period for which the non-employee is required to provide service in exchange for the award. For stock-based payments with performance conditions, the Company evaluates the probability of achieving performance conditions at each reporting date. The Company begins to recognize compensation cost using an accelerated attribution method when it is deemed probable that the performance condition will be met. The Company accounts for forfeitures as they occur.
Income taxes
The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when in management’s estimate, it is more likely than not, that the deferred tax assets will not be recovered.
Financial statement effects of uncertain tax positions are recognized when it is more likely than not, based on the technical merits of the position, that it will be sustained upon examination. It is the Company’s policy to include penalties and interest expense related to income taxes as a component of the provision for income taxes. Non-income-based taxes are expensed as incurred within operating expenses on the consolidated statements of operations.
Comprehensive loss
Comprehensive loss represents the net loss for the period and other comprehensive income (loss). Other comprehensive income (loss) reflects certain gains and losses that are recorded as a component of stockholders’ equity (deficit) and are not reflected in the consolidated statements of operations. The Company’s other comprehensive income (loss) consists of changes in unrealized gains and losses on available-for-sale marketable securities.
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Net loss per share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock (including pre-funded warrants) outstanding during the period, without consideration for all other common stock equivalents. Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date. Diluted net loss is calculated by dividing the net loss by the weighted-average number of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, options to purchase common stock, options early exercised subject to vesting, RSUs and shares expected to be purchased under the ESPP are considered to be potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented.
Recent Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) No. 2023‑07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures (ASU 2023-07), which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 should be applied on a retrospective basis. ASU 2023-07 is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company does not expect the adoption of this standard to have a material impact on the Company’s consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which is intended to enhance the transparency and decision usefulness of income tax disclosures, primarily by amending disclosure requirements for the effective tax rate reconciliation and income taxes paid. ASU 2023-09 should be applied on a prospective basis, and retrospective application is permitted. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is in the process of evaluating the impact of this new guidance on its disclosures.
In November 2024, the FASB issued ASU 2024-03—Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (ASU 2024-03), which is intended to enhance transparency into the nature and function of expenses, primarily through additional disclosures on certain cost and expenses. ASU 2024-03 should be applied on a prospective basis, and retrospective application is permitted. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is in the process of evaluating the impact of this new guidance on its disclosures.
3. Collaboration Agreements
Gilead
In June 2019, the Company entered into a global strategic collaboration agreement with Gilead (as subsequently amended, the Gilead Agreement) to discover, develop and commercialize a pipeline of targeted protein degradation drugs for patients with cancer and other challenging diseases using the Company’s DEL-AI platform to identify novel agents that utilize E3 ligases to induce degradation of five specified drug targets. In August 2019 and September 2022, the Company and Gilead entered into the First Amendment and the Second Amendment, respectively, to the Gilead Agreement to clarify certain language of the Gilead Agreement. These amendments had no impact on revenue recognition. In February and March 2024, as part of the existing collaboration agreement, Gilead elected to extend the five-year initial research term by two years for certain drug targets (Gilead Research Term Extension). The Gilead Research Term Extension triggered a $ 15.0 million payment that the Company received in the second quarter of fiscal year 2024.
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Under the Gilead Agreement, Gilead has the option to license drug candidates directed to up to five targets resulting from the collaboration and is responsible for the clinical development and commercialization of drug candidates resulting from the collaboration. The Company retains the option to co-develop and co-promote, under a profit share structure, up to two drug candidates in the United States, provided that the Company may only exercise such option once per licensed product and Gilead retains the right to veto the Company’s option selection for any one drug candidate of its choice. The collaboration excludes the Company’s current internal protein degradation programs for which the Company retains all rights, and also excludes the Company’s future internal programs, provided that the Company has distinguished future programs as excluded from the scope of the collaboration. In March 2023, Gilead exercised the option, which did not represent a material right at contract inception, since it was not offered for free or at a discount, to exclusively license one target (Gilead License Option Exercise), the first development candidate resulting from the Gilead Agreement. Pursuant to the Gilead Agreement, the Company received a license option exercise payment of $ 20.0 million in April 2023 for the Gilead License Option Exercise. The license to the functional intellectual property and all goods and services related to the Gilead License Option Exercise were transferred during the second quarter of fiscal year 2023.
Over time, Gilead may elect to replace the initial drug targets with other drug targets. For drug targets that are subject to the collaboration, the Company is obligated to use commercially reasonable efforts to undertake a research program in accordance with a research plan agreed to by the parties and established on a target-by-target basis. The Company has primary responsibility under the Gilead Agreement for performing preclinical research activities (including target validation, drug discovery, identification or synthesis) pursuant to a research plan. Each party will bear its own costs in the conduct of research activities. Gilead will be responsible for any development, commercialization and manufacturing activities, unless the Company exercises its co-development and co-promotion option. For those programs that the Company exercises its option to co-develop and co-promote, the Company and Gilead will split U.S. development costs as well as U.S. profits and losses evenly, and the Company will be eligible to receive royalties on net ex-U.S. sales and reduced milestone payments.
Upon signing the Gilead Agreement, Gilead paid the Company an upfront payment of $ 45.0 million plus $ 3.0 million in additional fees. In addition, from the signing of the Gilead Agreement to November 30, 2024, the Company has received payments of $ 47.0 million for research milestones and additional payments, $ 20.0 million for a license option exercise payment and $ 15.0 million in research term extension fees. As of November 30, 2024, the Company is eligible to receive up to approximately $ 1.8 billion in total additional payments, including payments of up to $ 513.5 million upon the achievement of specified research and development milestones, up to $ 60.0 million in certain additional fees related to target licensing and reservation and up to $ 1.2 billion upon the achievement of certain sales milestones. The Company also is eligible to receive mid-single digit to low tens percentage tiered royalties on annual net sales from any commercial products directed to the optioned collaboration targets, subject to certain reductions and excluding sales in the United States of any products for which the Company exercises its option to co-develop and co-promote, for which the parties share profits and losses evenly.
Subject to earlier expiration in certain circumstances, the Gilead Agreement expires on a licensed product-by-licensed product and country-by-country basis upon the later of (1) the expiration of the last to expire patent with a valid claim covering the applicable licensed product in the applicable country, (2) the expiration of any regulatory exclusivity for the applicable licensed product in the applicable country or (3) ten years after the first commercial sale of the applicable licensed product in the applicable country covered by the Gilead Agreement, provided that the term for any profit-shared licensed product in the United States will expire upon the expiration or termination of the applicable profit-share term as set forth in an applicable profit-share agreement to be negotiated upon the Company’s exercise of its option to co-develop and co-promote such licensed product.
The Company identified the following promises in the Gilead Agreement: (1) the research licenses, (2) the research services, including selection campaign research services for certain replacement targets, (3) the obligation to share information during the research term and (4) the participation in the joint research committee and joint steering committee. The Company determined that the research licenses, the obligation to share information and the participation in joint committees are not capable of being distinct from the research services due to the specialized nature of the research services to be provided by the Company, and, accordingly, the promises identified were combined as one single performance obligation. The Company also concluded that, at the inception of the Gilead Agreement, Gilead’s options to obtain an exclusive development, manufacturing and commercialization license for each collaboration target, to extend the five-year research term and to perform selection campaign research services for certain replacement targets do not represent material rights and are not considered performance obligations because they do not contain a significant and incremental discount. The Company concluded that Gilead’s target reservation right is not a performance obligation as it does not require any specific action from the Company and it is rather an exclusivity right and an attribute of other performance obligations in the Gilead Agreement, such as the research licenses.
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In order to determine the transaction price, the Company evaluated all the payments to be received during the duration of the contract. Certain milestone payments and additional fees were considered variable consideration, which were not included in the transaction price based on the most likely amount method as of November 30, 2024. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The Company determined that the transaction price at the inception of the initial research term consisted of the upfront payment of $ 45.0 million and $ 3.0 million in additional fees. Upon the achievement of research milestones and additional fees related to target reservations, $ 47.0 million in variable consideration was added to the transaction price, and a cumulative effect was recorded as revenue in the period the transaction price increased. The transaction price is recognized as collaboration revenue using the cost-based input method over the estimated initial research term of five years , which represents the estimated timing of completion of the identified deliverables. Additionally, the Company considered the impact of Gilead terminating the Gilead Agreement prior to the completion of the research services during the five-year initial research term and determined that there were significant economic costs to Gilead for doing so, and as such, did not adjust the contract term.
The Gilead Research Term Extension, which has a term of two years and did not represent a material right at the inception of the Gilead Agreement because it does not contain a significant and incremental discount, is accounted for as a separate contract commencing in June 2024. The research term extension fee of $ 15.0 million is recognized as collaboration revenue using the cost-based input method over the estimated extended research term of two years , which represents the estimated timing of completion of the identified deliverables. As of November 30, 2024, no milestones have been achieved related to the extended research term.
Using the cost-based input method, which the Company determined most faithfully depicts the transfer of its performance obligation to Gilead, the Company recognizes revenue based on actual costs incurred as a percentage of total estimated costs as the Company completes its performance obligation under the contract. Costs consist primarily of internal full-time employee (FTE) and third-party contract costs related to the Gilead Agreement. The cumulative effect of revisions to estimated costs to complete the Company’s performance obligation is recorded in the period in which changes are identified and amounts can be reasonably estimated. Total estimated costs are primarily driven by the number of estimated FTEs, which requires significant management judgment.
For the year ended November 30, 2024, the Company recognized collaboration revenue related to the initial research term under the Gilead Agreement of $ 10.0 million, all of which was included in deferred revenue as of the beginning of the period. The Company also recognized collaboration revenue related to the Gilead Research Term Extension of $ 4.0 million, all of which was related to the $ 15.0 million research term extension fee received in the second quarter of fiscal year 2024. For the year ended November 30, 2023, the Company recognized collaboration revenue related to the Gilead Agreement of $ 29.9 million, of which $ 20.3 million was included in deferred revenue as of the beginning of the period, and $ 7.9 million was related to activities satisfied in previous periods. The Company also recognized $ 20.0 million in license revenue received pursuant to the Gilead License Option Exercise during the year ended November 30, 2023. For the year ended November 30, 2022, the Company recognized collaboration revenue related to the Gilead Agreement of $ 23.7 million, of which $ 18.4 million was included in deferred revenue as of the beginning of the period, and $ 4.0 million was related to activities satisfied in previous periods. As of November 30, 2024, deferred revenue related to the Gilead Agreement was $ 11.0 million, of which $ 9.1 million was current. As of November 30, 2023, deferred revenue related to the Gilead Agreement was $ 10.0 million, all of which was current.
Sanofi
In December 2019, the Company entered into a strategic collaboration with Genzyme Corporation, a subsidiary of Sanofi, which became effective in January 2020 (as subsequently expanded and amended, the Sanofi Agreement), to discover, develop and commercialize a pipeline of targeted protein degradation drugs for patients with challenging diseases in multiple therapeutic areas using the Company’s DEL-AI platform to identify small molecules designed to induce degradation of three specified initial drug targets. In January 2021, as part of the existing Sanofi Agreement, Sanofi paid the Company $ 22.0 million to exercise its option to expand the number of targets in the Sanofi Agreement from three to a total of five targets.
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In January 2021, the Company and Sanofi entered into the First Amendment to the Sanofi Agreement to modify the research term on all targets (the First Sanofi Amendment). In December 2021, the Company and Sanofi entered into the Second Amendment to the Sanofi Agreement to extend the substitution deadline on certain targets. In July 2022, the Company and Sanofi entered into the Third Amendment to the Sanofi Agreement to further extend the substitution deadline on certain targets. The extensions of the substitution deadline had no impact on revenue recognition. Also in July 2022, Sanofi elected to replace certain drug targets, and the substitution extended the research term of those targets by one year to 5.25 years and increased overall forecasted costs, which had an immaterial impact on revenue recognition. In August 2022 and November 2023, the Company and Sanofi entered into the Fourth Amendment and Fifth Amendment, respectively, to the Sanofi Agreement to modify the research plan for certain targets, which had no impact on revenue recognition. In March 2024, the Company and Sanofi entered into the Sixth Amendment to the Sanofi Agreement to extend the research term for the collaboration target STAT6, a key drug target in type 2 inflammation, by two years (the Sixth Sanofi Amendment), which has increased overall forecasted costs and has an impact on revenue recognition.
Under the Sanofi Agreement, Sanofi has exclusive rights and is responsible for the clinical development, commercialization and manufacture of drug candidates resulting from the collaboration while the Company retains the option to co-develop, co-promote and co-commercialize all drug candidates in the United States directed to up to two targets, one of which must be selected from a list of targets designated at the execution of the Sanofi Agreement or any replacement of such targets, and one of which must be selected from targets identified by Sanofi as part of their January 2021 expansion. The Company’s right to exercise its option to co-develop, co-promote and co-commercialize a given target is dependent on its ability to demonstrate, within a given timeframe, that it has sufficient cash resources and personnel to commercialize the product. The collaboration excludes the Company’s current internal protein degradation programs for which it retains all rights, and also excludes its future internal programs, provided that the Company distinguished future programs as excluded from the scope of the collaboration.
For drug targets that are subject to the collaboration, the Company has primary responsibility for conducting preclinical research activities (including target validation, drug discovery, identification or synthesis) in accordance with the applicable research plan agreed to by the parties and established on a target-by-target basis. The Company is obligated to use commercially reasonable efforts to identify relevant target binders and targeted protein degraders in order to identify development candidates. Subject to certain exceptions, each party will bear its own costs in the conduct of such research. Sanofi will be responsible for any development and commercialization activities unless the Company exercises its co-development and co-promotion option. For those programs that the Company exercises its option to co-develop, co-promote and co-commercialize, the Company will be responsible for a portion of the U.S. development costs, and the parties will split U.S. profits and losses evenly and the Company will be eligible to receive royalties on ex-U.S. net sales and reduced milestone payments on such optioned products.
Upon signing the Sanofi Agreement, Sanofi paid the Company an upfront payment of $ 55.0 million. Subsequently, in January 2021, Sanofi paid the Company an additional $ 22.0 million to exercise its option to expand the number of targets beyond the initial targets included in the collaboration. In addition, from the signing of the Sanofi Agreement to November 30, 2024, the Company has received payments of $ 13.0 million for research milestones. As of November 30, 2024, the Company is eligible to receive up to approximately $ 1.9 billion in total additional payments, including payments of up to $ 389.0 million upon the achievement of specified research and development milestones, up to $ 61.8 million in certain additional fees related to target licensing and reservation, up to $ 500.0 million upon the achievement of specified regulatory milestones and up to $ 1.0 billion upon the achievement of certain sales milestones. The Company is also eligible to receive mid-single digit to low teen percentage tiered royalties on annual net sales of any commercial products that may result from the collaboration, subject to certain reductions and excluding sales in the United States of any products for which the Company exercises its option to co-develop and co-promote, for which the parties share profits and losses evenly.
Subject to earlier expiration in certain circumstances, the Sanofi Agreement expires on a licensed product-by-licensed product or profit-shared licensed product-by-profit-shared licensed product basis and country-by-country basis upon on the later of (1) the expiration of the last-to-expire patent with a valid claim covering the applicable licensed product in the applicable country, (2) the expiration of any regulatory exclusivity for the applicable licensed product in the applicable country or (3) ten years after the first commercial sale of the applicable licensed product in the applicable country covered by the Sanofi Agreement.
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The Company identified the following promises in the Sanofi Agreement: (1) the research licenses, (2) the research services, (3) the obligation to share information during the research term and (4) the participation of alliance managers in the joint research committee and joint patent committee. The Company determined that the research licenses, the obligation to share information and the participation in the joint committees are not capable of being distinct from the research services due to the specialized nature of the research services to be provided by the Company, and, accordingly, the promises identified were combined as one single performance obligation. The Company also determined that Sanofi’s exclusive right to add up to two additional targets constitutes a material right as it represents a significant and incremental discount that Sanofi would not have received without entering into the Sanofi Agreement. The option to extend the license term does not represent a material right because it does not contain a significant and incremental discount.
In order to determine the transaction price, the Company evaluated all the payments to be received during the duration of the contract. Certain milestone payments and additional fees were considered variable consideration, which were not included in the transaction price based on the most likely amount method as of November 30, 2024. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. At the inception of the Sanofi Agreement, the Company determined that the transaction price consisted of the upfront payment of $ 55.0 million for three initial drug targets and $ 22.0 million for two additional targets. Subsequently, upon the achievement of research milestones, $ 13.0 million in variable consideration was added to the transaction price, and a cumulative effect was recorded as revenue in the period the transaction price increased. Revenue is recognized using the cost-based input method over the research term of 4.25 years, the revised research period that was agreed to in January 2021 in the First Sanofi Amendment for certain targets, and 5.25 years, the revised research period due to the target substitutions in July 2022, for certain other targets. The research period was extended as part of the Sixth Sanofi Amendment and a cumulative effect was recorded in the second quarter of fiscal year 2024.
Using the cost-based input method, which the Company determined most faithfully depicts the transfer of its performance obligation to Sanofi, the Company recognizes revenue based on actual costs incurred as a percentage of total estimated costs as the Company completes its performance obligation under the contract. Costs consist primarily of internal FTE and third-party contract costs related to the Sanofi Agreement. The cumulative effect of revisions to estimated costs to complete the Company’s performance obligation is recorded in the period in which changes are identified and amounts can be reasonably estimated. Total estimated costs are primarily driven by the number of estimated FTEs, which requires significant management judgment.
For the year ended November 30, 2024, the Company recognized collaboration revenue related to the Sanofi Agreement of $ 21.7 million, of which $ 20.2 million was included in deferred revenue as of the beginning of the period, and $ 1.1 million was related to activities satisfied in previous periods. For the year ended November 30, 2023, the Company recognized collaboration revenue related to the Sanofi Agreement of $ 25.4 million, of which $ 21.0 million was included in deferred revenue as of the beginning of the period, and $ 2.6 million was related to activities satisfied in previous periods. For the year ended November 30, 2022, the Company recognized collaboration revenue related to the Sanofi Agreement of $ 15.0 million, of which $ 14.0 million was included in deferred revenue as of the beginning of the period, and $ 0.6 million was related to activities satisfied in previous periods. As of November 30, 2024, deferred revenue related to the Sanofi Agreement was $ 9.1 million, all of which was current. As of November 30, 2023, deferred revenue related to the Sanofi Agreement was $ 24.9 million, of which $ 20.3 million was current, and included $ 4.0 million in contract assets representing the unbilled amount related to the research milestone achieved in November 2023.
Pfizer
In September 2023, the Company entered into a strategic collaboration with Seagen Inc. (now a part of Pfizer Inc.) (the Pfizer Agreement) to develop a suite of targeted protein degraders against multiple targets nominated by Pfizer that are suitable for antibody conjugation. Pfizer will be responsible for conjugating these degraders to antibodies to make degrader antibody conjugates (DACs), a new class of medicines for use in cancer treatment, and advancing these DAC drug candidates through preclinical and clinical development and commercialization.
Under the Pfizer Agreement, Pfizer has the option to obtain exclusive licenses to develop and commercialize certain degraders, while the Company retains an option for U.S. profit sharing and co-promotion on two products arising from the collaboration. The collaboration excludes the Company’s current internal protein degradation programs for which the Company retains all rights, and also excludes the Company’s future internal programs, provided that the Company has distinguished future programs as excluded from the scope of the collaboration.
For the targets nominated by Pfizer under the collaboration, the Company shall use commercially reasonable efforts to identify, synthesize, characterize and deliver targeted protein degraders that selectively bind to and degrade such targets. Development of licensed degraders, with the exception of licensed products for which the Company exercises its profit-share options, will be at Pfizer’s sole cost and expense. For the profit-share products, the parties will share net profits and net losses and global development costs, and the Company will be eligible to receive royalty and milestone payments on such optioned products.
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Under the terms of the Pfizer Agreement, the Company received an upfront payment of $ 60.0 million. In addition, from the signing of the Pfizer Agreement to November 30, 2024, the Company has received a payment of $ 5.0 million in connection with the achievement of a research milestone in May 2024. Additionally, the Company achieved another research milestones in November 2024 and received a payment of $ 5.0 million in January 2025 as a result. The Company is eligible to receive up to approximately $ 3.4 billion in contingent payments across multiple programs, including payments of up to $ 626.0 million upon the achievement of specified research and development milestones, up to $ 19.5 million in certain additional fees related to target licensing and reservation, up to $ 873.0 million upon the achievement of specified regulatory milestones and up to $ 1.8 billion upon the achievement of certain sales milestones. The Company is also eligible for mid-single to low double digit percentage tiered royalties on future sales.
Subject to the exceptions described in the Pfizer Agreement, the Pfizer Agreement expires upon the first to occur of (1) the expiration of the last-to-expire option exercise period under the Pfizer Agreement if no such option has been exercised prior to such expiration and (2) the expiration of the last-to-expire royalty term under the Pfizer Agreement.
The Company identified the following promises in the Pfizer Agreement: (1) the research licenses, (2) the research services, (3) the participation of a gatekeeper and an alliance managers and the participation in various joint committees, and (4) the obligation to share information during the research term. The Company determined that the research licenses, the participation in the joint committees and the obligation to share information are not capable of being distinct from the research services, and, accordingly, the identified promises were combined as one single performance obligation. The Company also determined that, at the inception of the Pfizer Agreement, Pfizer’s options to obtain an exclusive development, manufacturing and commercialization license for each collaboration target and to extend the four-year research term do not represent material rights and are not considered performance obligations because they do not contain a significant and incremental discount. Additionally, Pfizer’s target reservation right is not a performance obligation as it is an exclusivity right and an attribute of other performance obligations in the Pfizer Agreement, such as the research licenses, and does not require any specific actions from the Company.
In order to determine the transaction price, the Company evaluated all the payments to be received during the duration of the contract. Milestone payments and additional fees were considered variable consideration, which were not included in the transaction price based on the most likely amount method as of November 30, 2024. The Company re-evaluates the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The Company determined that the transaction price at the inception of the Pfizer Agreement consisted of the upfront payment of $ 60.0 million. Subsequently, upon the achievement of research milestones in May 2024 and November 2024, $ 10.0 million in variable consideration was added to the transaction price and a cumulative effect was recorded as revenue in the period the transaction price increased. The transaction price is recognized as collaboration revenue using the cost-based input method over the estimated research term of 4 years, not to extend beyond 6 years , which represents the estimated period to complete the identified deliverables. Additionally, the Company considered the impact of Pfizer terminating the Pfizer Agreement prior to the completion of the research services during the initial four-year research term and determined that there were significant economic costs to Pfizer for doing so, and as such, did not adjust the contract term.
Using the cost-based input method, which the Company determined most faithfully depicts the transfer of its performance obligation to Pfizer, the Company recognizes revenue based on actual costs incurred as a percentage of total estimated costs as the Company completes its performance obligation under the contract. Costs consist primarily of internal FTE and third-party contract costs related to the Pfizer Agreement. The cumulative effect of revisions to estimated costs to complete the Company’s performance obligation is recorded in the period in which changes are identified and amounts can be reasonably estimated. Total estimated costs are primarily driven by the number of estimated FTEs, which requires significant management judgment.
For the year ended November 30, 2024, the Company recognized collaboration revenue related to the Pfizer Agreement of $ 18.8 million, of which $ 16.6 million was included in deferred revenue as of the beginning of the period and $ 0.3 million was related to activities satisfied in previous periods. For the year ended November 30, 2023, the Company recognized collaboration revenue related to the Pfizer Agreement of $ 1.7 million. As of November 30, 2024, deferred revenue related to the Pfizer Agreement was $ 44.5 million, of which $ 20.0 million was current, and included $ 5.0 million in contract assets representing the unbilled amount related to the research milestone achieved in November 2024. As of November 30, 2023, deferred revenue related to the Pfizer Agreement was $ 58.3 million, of which $ 17.9 million was current.
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4. Consolidated Balance Sheet Components
Property and Equipment, Net
Property and equipment, net, consisted of the following (in thousands):
November 30,
2024 2023
Laboratory equipment $ 39,031 $ 32,239
Leasehold improvements 5,140 3,238
Computer equipment 936 938
Furniture and fixtures 1,077 652
Software 5,578 5,403
Software in progress 497 587
Total property and equipment, gross 52,259 43,057
Less: Accumulated depreciation and amortization ( 34,502 ) ( 26,249 )
Total property and equipment, net $ 17,757 $ 16,808
For the years ended November 30, 2024, 2023 and 2022, depreciation and amortization expense was $ 9.3 million, $ 7.5 million and $ 5.3 million, respectively, which includes amortization expense related to capitalized software of $ 1.3 million, $ 1.4 million and $ 1.2 million, respectively. All long-lived assets are maintained in the United States.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
November 30,
2024 2023
Accrued compensation $ 16,631 $ 15,303
Accrued contract research and lab supplies 11,599 3,767
Accrued clinical 4,637 3,364
Accrued professional services 1,615 1,755
Accrued taxes 1,237 30
Other 2,275 751
Total accrued expenses and other current liabilities $ 37,994 $ 24,970
5. Fair Value Measurements
In accordance with the authoritative guidance on fair value measurements and disclosures under U.S. GAAP, the Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:
Level 1—Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date;
Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability either directly or indirectly, including inputs in markets that are not considered to be active; and
Level 3—Inputs that are unobservable.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability.
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The following tables present the Company’s investments, which consist of cash equivalents and available-for-sale marketable securities, that are measured at fair value on a recurring basis as of November 30, 2024 and 2023 (in thousands):
November 30, 2024 Level Amortized
cost Unrealized
gain Unrealized
loss Estimated
fair value
Money market funds Level 1 $ 90,380 $ — $ — $ 90,380
U.S. treasury securities Level 1 470,607 271 ( 138 ) 470,740
U.S. government agency securities Level 2 28,829 32 ( 15 ) 28,846
Total $ 589,816 $ 303 $ ( 153 ) $ 589,966
Included in cash and cash equivalents $ 90,380 $ — $ — $ 90,380
Included in marketable securities, current $ 499,436 $ 303 $ ( 153 ) $ 499,586
November 30, 2023 Level Amortized
cost Unrealized
gain Unrealized
loss Estimated
fair value
Money market funds Level 1 $ 44,187 $ — $ — $ 44,187
U.S. treasury securities Level 1 160,991 61 ( 29 ) 161,023
Corporate debt securities Level 2 3,487 — ( 56 ) 3,431
U.S. government agency securities Level 2 69,389 5 ( 567 ) 68,827
Long-term marketable securities:
U.S. government agency securities Level 2 7,490 — ( 69 ) 7,421
Total $ 285,544 $ 66 $ ( 721 ) $ 284,889
Included in cash and cash equivalents $ 44,187 $ — $ — $ 44,187
Included in marketable securities, current $ 233,867 $ 66 $ ( 652 ) $ 233,281
Included in marketable securities, non-current $ 7,490 $ — $ ( 69 ) $ 7,421
The following table summarizes the available-for-sale marketable securities in an unrealized loss position for which an allowance for credit losses has not been recorded as of November 30, 2024 and 2023, aggregated by investment category and length of time in a continuous unrealized loss position (in thousands):
Less than 12 months Greater than 12 months Total
November 30, 2024 Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss
U.S. treasury securities $ 166,161 $ ( 138 ) $ — $ — $ 166,161 $ ( 138 )
U.S. government agency securities — — 3,981 ( 15 ) 3,981 ( 15 )
Total $ 166,161 $ ( 138 ) $ 3,981 $ ( 15 ) $ 170,142 $ ( 153 )
Less than 12 months Greater than 12 months Total
November 30, 2023 Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss
U.S. treasury securities $ 46,694 $ ( 4 ) $ 5,936 $ ( 25 ) $ 52,630 $ ( 29 )
Corporate debt securities — — 3,431 ( 56 ) 3,431 ( 56 )
U.S. government agency securities 23,599 ( 108 ) 48,805 ( 528 ) 72,404 ( 636 )
Total $ 70,293 $ ( 112 ) $ 58,172 $ ( 609 ) $ 128,465 $ ( 721 )
The accrued interest receivable related to the Company’s marketable securities was $ 1.5 million and $ 0.8 million as of November 30, 2024 and 2023, respectively, and was included in prepaid expenses and other current assets on the consolidated balance sheet. Long-term marketable securities held by the Company generally mature within two years from the balance sheet date.
The Company classifies its money market funds and U.S. treasury securities, which are valued based on quoted market prices in active markets with no valuation adjustment, as Level 1 assets within the fair value hierarchy.
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The Company classifies its marketable securities in corporate debt securities and U.S. government agency securities, as Level 2 assets within the fair value hierarchy. The fair values of these marketable securities are estimated by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data and other observable inputs. There were no transfers of financial instruments between valuation levels during the years ended November 30, 2024 and 2023.
As of November 30, 2024 and 2023, the unrealized losses for available-for-sale marketable securities were non-credit related, and the Company does not intend to sell the securities that were in an unrealized loss position, nor will it be required to sell those securities before recovery of their amortized cost basis, which may be maturity. As of November 30, 2024 and 2023, no allowance for credit losses for the Company’s marketable securities was recorded. During the years ended November 30, 2024, 2023 and 2022, the Company did not recognize any impairment losses related to marketable securities.
6. Commitments and Contingencies
Legal Proceedings
From time to time, the Company may be involved in legal proceedings in the ordinary course of business. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. Legal fees and other costs associated with such actions are expensed as incurred. As of November 30, 2024, the Company was not a party to any material legal proceedings.
Indemnifications
In the ordinary course of business, the Company often includes standard indemnification provisions in its arrangements with its partners, suppliers and vendors, among others. Pursuant to these provisions, the Company may be obligated to indemnify such parties for losses or claims suffered or incurred in connection with its service, breach of representations or covenants, intellectual property infringement or other claims made against such parties. These provisions may limit the time within which an indemnification claim can be made. It is not possible to determine the maximum potential amount under these indemnification obligations due to the limited history of prior indemnification claims and the unique facts and circumstances involved in each particular agreement. The Company has not incurred any material costs as a result of such indemnifications and has not accrued any liabilities related to such obligations in these consolidated financial statements as management believes such liability is immaterial.
In addition, the Company has entered into indemnification agreements with directors and certain officers and employees that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers or employees. No demands have been made upon the Company to provide indemnification under such agreements, and thus, there are no claims that the Company is aware of that could have a material effect on the consolidated financial statements. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is not specified in the agreements. However, the Company currently has directors’ and officers’ insurance that reduces its exposure and may enable the Company to recover a portion of any future amounts paid.
Operating Leases
The Company leases office and laboratory facilities totaling approximately 57,902 square feet within the same building in San Francisco, California under several lease agreements. The terms of these lease agreements expire in April 2025. The Company had an option to renew these leases for an additional two years , and the option expired. In September 2024, an amendment was signed to extend the lease term for these leases through October 2025, and the minimum rent payable by the Company pursuant to this amendment is approximately $ 0.4 million per month. The lease amendment did not have a material impact on the Company’s consolidated financial statements.
149
In July 2021, the Company entered into a lease agreement for the lease of approximately 19,320 square feet of office space in a different building in San Francisco, California (the Mission Bay Lease). The lease commenced in December 2021 and was scheduled to expire in June 2024. In March 2024, the Company entered into a second amendment (the Second Amendment) to the Mission Bay Lease, pursuant to which the lease term was extended through April 2025. The minimum rent payable by the Company under the Second Amendment is approximately $ 0.1 million per month. In September 2024, the Mission Bay Lease was further amended (the Third Amendment) to extend the lease term through October 2025, and the minimum rent payable by the Company under the Third Amendment is approximately $ 0.1 million per month. The lease amendments did not have a material impact on the Company’s consolidated financial statements.
In March 2022, the Company entered into a lease agreement for the lease of approximately 46,434 square feet of office space in The Woodlands, Texas. In August 2023, the lease agreement was amended to increase the square footage of the leased premise to 50,094 square feet. The amendment had no impact on the accounting for the lease. The Company has an option to renew for two additional terms of five years each, and the renewal terms have not been included in the lease term used to calculate the ROU asset and lease liability as it is not reasonably certain that the Company will exercise the option. The lease commenced in September 2023 when the underlying assets became available for use and will expire in March 2035.
The Company is required to pay base rent plus its proportionate share of operating expenses, as defined in the applicable lease agreement on all of its leases. Variable lease payments related to operating expenses including utilities, maintenance costs and real estate taxes were $ 7.0 million, $ 6.2 million and $ 4.4 million for the years ended November 30, 2024, 2023 and 2022, respectively.
Operating lease expenses, excluding variable lease payments, were $ 9.0 million, $ 6.8 million and $ 5.9 million for the years ended November 30, 2024, 2023 and 2022, respectively. Short-term lease expense was not material for the periods presented. As of November 30, 2024, the weighted average remaining lease term was 8.5 years and the weighted average discount rate was 6.84 %.
Other information related to leases were as follows (in thousands):
Year Ended November 30,
2024 2023 2022
Cash paid for amounts included in the measurement of lease liabilities:
Cash flows from operating leases $ 8,320 $ 6,973 $ 6,578
The undiscounted future non-cancellable lease payments under the Company’s lease agreements as of November 30, 2024 were as follows (in thousands):
Year ending November 30, Operating
Leases
2025 $ 8,240
2026 2,912
2027 2,992
2028 3,074
2029 3,159
2030 to 2035 18,073
Total undiscounted lease payments 38,450
Less: imputed interest ( 10,147 )
Total operating lease liabilities $ 28,303
Operating lease liabilities, current $ 8,014
Operating lease liabilities, net of current portion 20,289
Total operating lease liabilities $ 28,303
7. Common Stock
The Company’s Restated Certificate of Incorporation authorizes the Company to issue up to 500,000,000 shares of common stock, $ 0.001 par value per share, as of November 30, 2024 and 2023. Holders of common stock are entitled to dividends when and if declared by the Company’s board of directors, subject to the prior rights of the holders of shares of preferred stock. The holder of each share of common stock is entitled to one vote. As of November 30, 2024, no dividends have been declared.
150
In July 2022, the Company issued the 2022 Pre-Funded Warrants to purchase an aggregate of 6,814,920 shares of the Company’s common stock at a price of $ 13.939 per pre-funded warrant. As of November 30, 2024, a total of 6,097,560 of the 2022 Pre-Funded Warrants remained available for exercise.
In April 2024, the Company issued the 2024 Pre-Funded Warrants to purchase an aggregate of 1,500,100 shares of the Company’s common stock at a price of $ 14.999 per pre-funded warrant. As of November 30, 2024, a total of 1,480,349 of the 2024 Pre-Funded Warrants remained available for exercise.
All pre-funded warrants were immediately exercisable at issuance, have an exercise price of $ 0.001 and may be exercised at any time after the date of issuance. A holder of pre-funded warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99 % of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise. A holder of the pre-funded warrants may increase or decrease this percentage not in excess of 19.99 % by providing at least 61 days’ prior notice to the Company.
The pre-funded warrants were classified as a component of permanent equity on the consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. All of the shares underlying the pre-funded warrants have been included in the weighted-average number of shares of common stock used to calculate net loss per share, basic and diluted, attributable to common stockholders because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date of the pre-funded warrants.
Common stock reserved for future issuance, on an as-if converted basis, as of November 30, 2024 and 2023, consists of the following:
November 30,
2024 2023
Options to purchase common stock issued and outstanding 9,839,454 8,340,968
Restricted stock units issued and outstanding 1,956,015 1,246,031
Shares available for future equity grants 3,192,811 1,614,035
Shares available for issuance under employee stock purchase plan 1,740,988 1,530,281
Pre-funded warrants issued and outstanding 7,577,909 6,097,560
Total common stock reserved for future issuance 24,307,177 18,828,875
8. Stock-Based Compensation
Equity Incentive Plans
The Company’s 2020 Equity Incentive Plan (the 2020 Plan) serves as the successor to the Company’s 2012 Equity Incentive Plan (together with the 2020 Plan, the Stock Plans) and provides for the granting of stock options, stock appreciation rights, restricted stock awards (RSUs), performance awards and stock bonus awards to employees, directors, consultants, independent contractors and advisors of the Company.
Under the Stock Plans, the Company generally grants stock-based awards with service-based vesting conditions only. Options granted typically vest under various different vesting terms over a four-year period and expire ten years from the date of grant. In the case of an incentive stock option granted to an employee who at the time of grant owns stock representing more than 10 % of the total combined voting power of all classes of stock, the exercise price shall be no less than 110 % of the fair value per share on the date of grant, and the award shall expire five years from the date of grant. In the case of all other stock options, the per share exercise price shall be no less than 100 % of the fair value per share on the date of grant. RSUs issued typically vest under various different vesting terms over a two - to four-year period.
Following the effectiveness of the 2020 Plan on July 22, 2020, the Company ceased making grants under the 2012 Plan. However, the 2012 Plan continues to govern the terms and conditions of the outstanding awards granted under it. Shares of common stock subject to awards granted under the 2012 Plan that cease to be subject to such awards by forfeiture or otherwise will be available for issuance under the 2020 Plan.
As of November 30, 2024, there were 3,192,811 shares of common stock reserved for future issuance pursuant to the 2020 Plan and the 2024 Inducement Plan (defined below).
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Equity Inducement Plan
In October 2024, the Board adopted and approved the Company’s 2024 Equity Inducement Plan (the 2024 Inducement Plan), which became effective on October 23, 2024. In accordance with Rule 5635(c)(4) of the Nasdaq listing rules, equity awards under the 2024 Inducement Plan may only be made to an employee if he or she is granted such awards in connection with the commencement of his or her employment with the Company and such grant is a material inducement to his or her entering into employment with the Company.
The Company has reserved 3,000,000 shares of common stock for issuance pursuant to non-qualified stock options and RSUs under the 2024 Inducement Plan. As of November 30, 2024, no shares had been issued under the 2024 Inducement Plan.
Stock options
Option activity under the Stock Plans is set forth below:
Number of
options
outstanding Weighted-
average
exercise
price Weighted-
average
contractual
life
(in years) Aggregate
intrinsic
value (1)
(in thousands)
Balances as of November 30, 2023 8,340,968 $ 17.17 7.77 $ 3,295
Options granted 2,840,341 11.69
Options exercised ( 508,648 ) 9.94
Options forfeited ( 833,207 ) 19.39
Balances as of November 30, 2024 9,839,454 $ 15.77 7.45 $ 80,434
Options vested and expected to vest as of November 30, 2024
9,839,454 $ 15.77 7.45 $ 80,434
Options exercisable as of November 30, 2024 6,085,527 $ 17.05 6.66 $ 47,556
(1)
The aggregate intrinsic values were calculated as the pre-tax difference between the exercise price of stock options and the quoted market price of the Company’s common stock on November 30, 2024 for all in‑the‑money stock options. The total intrinsic value of stock options exercised during the years ended November 30, 2024, 2023 and 2022 was $ 5.6 million, $ 0.2 million and $ 4.5 million, respectively.
The fair value of options granted during the years ended November 30, 2024, 2023 and 2022 was estimated using the Black-Scholes option pricing model on the grant date using the following assumptions:
November 30,
2024 2023 2022
Expected term (years) 5.50 - 6.13
5.50 - 6.06
5.50 - 6.07
Expected volatility 71 % - 83 %
74 % - 92 %
70 % - 74 %
Risk-free interest rate 3.45 % - 4.43 %
3.27 % - 4.59 %
1.31 % - 4.22 %
Dividend yield 0 % 0 % 0 %
The expected term represents the weighted-average period the stock-based payments are expected to remain outstanding. The expected term assumption for stock options was determined using the simplified method for “plain-vanilla” options. The expected stock price volatility assumption was determined using a blended volatility by examining the historical volatilities for industry peers and the volatility of the Company’s stock following the IPO. The risk-free rate assumption is based on the U.S. Treasury yield curve whose term is consistent with the expected term of the stock options. The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The expected dividend yield is 0 % as the Company has not paid and does not anticipate paying dividends on its common stock.
During the years ended November 30, 2024, 2023 and 2022, the weighted-average grant date fair value of options granted was $ 7.96 , $ 7.22 and $ 11.80 per share, respectively.
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Restricted stock units
RSU activity under the Stock Plans is set forth below:
Number of RSUs Weighted-average grant date fair value
Balances as of November 30, 2023 1,246,031 $ 12.58
RSUs granted 1,698,305 11.18
RSUs vested ( 654,396 ) 11.69
RSUs forfeited ( 333,925 ) 11.60
Balances as of November 30, 2024 1,956,015 $ 11.83
During the years ended November 30, 2024, 2023 and 2022, the weighted-average grant date fair value of RSUs granted was $ 11.18 , $ 10.53 and $ 19.11 per share, respectively, and the total fair value of RSUs vested was $ 7.6 million, $ 7.9 million and $ 0.9 million, respectively.
Employee Stock Purchase Plan
Under the Company’s ESPP, eligible employees are entitled to purchase shares of common stock at a discount with accumulated payroll deductions. The purchase price for shares of common stock purchased under the ESPP will be 85 % of the lesser of the fair market value of the Company’s common stock on (i) the first trading day of the applicable offering period or (ii) the last trading day of each purchase period in the applicable offering period.
During the year ended November 30, 2024, the Company issued 276,478 shares of common stock pursuant to the ESPP at a weighted-average price of $ 7.71 per share. As of November 30, 2024, there were 1,740,988 shares of common stock reserved for issuance pursuant to the ESPP.
The fair value of shares granted under the ESPP during the years ended November 30, 2024, 2023 and 2022 was estimated using the Black-Scholes option pricing model on the grant date using the following assumptions:
November 30,
2024 2023 2022
Expected term (years) 0.5
0.5
0.5
Expected volatility 80 % - 85 %
67 %
70 % - 101 %
Risk-free interest rate 5.02 % - 5.31 %
4.98 % - 5.54 %
0.67 % - 3.12 %
Dividend yield 0 % 0 % 0 %
Stock-Based Compensation
Stock-based compensation expense related to the Stock Plans and the ESPP that is included in the consolidated statements of operations is as follows (in thousands):
Year Ended November 30,
2024 2023 2022
Research and development $ 17,763 $ 18,707 $ 16,808
General and administrative 16,166 14,966 11,323
Total stock-based compensation $ 33,929 $ 33,673 $ 28,131
During the years ended November 30, 2024, 2023 and 2022, capitalized stock-based compensation related to internal-use software development was $ 14,000 , $ 74,000 and $ 69,000 , respectively. As of November 30, 2024, the total compensation cost related to stock-based awards not yet recognized was $ 52.8 million, which is expected to be amortized on a straight-line basis over the weighted-average remaining vesting period of approximately 2.22 years.
9. Defined Contribution Plan
The Company sponsors a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code of 1986, as amended (the 401(k) Plan), which provides for the Company to make discretionary matching or discretionary annual contributions to the 401(k) Plan, for its employees. Substantially all of the Company’s employees are eligible to participate in the 401(k) Plan. Employees may contribute a percentage of their annual compensation to the plan, subject to statutory limitations. The Company has made contributions to the 401(k) Plan and recorded contribution expense of $ 0.9 million, $ 1.0 million and $ 0.9 million during the years ended November 30, 2024, 2023 and 2022, respectively.
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10. Income Taxes
For the year ended November 30, 2024, the Company recorded an income tax provision of $ 270,000 . For the years ended November 30, 2023 and 2022, the Company did no t record any current income tax expense or provision. The Company has generated net operating losses (NOLs) since inception and has established a valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets.
Loss before provision for income taxes includes the following component (in thousands):
November 30,
2024 2023 2022
Domestic $ ( 193,299 ) $ ( 143,948 ) $ ( 180,360 )
$ ( 193,299 ) $ ( 143,948 ) $ ( 180,360 )
The provision for income taxes consists of the following (in thousands):
November 30,
2024 2023 2022
Current:
Federal $ 270 $ — $ —
State — — —
Total provision for income taxes $ 270 $ — $ —
The effective tax rate differs from the federal statutory rate as follows:
November 30,
2024 2023 2022
Federal statutory income tax rate 21.0 % 21.0 % 21.0 %
State income tax rate ( 4.9 ) 14.1 5.9
Research and development tax credits 4.1 4.8 3.5
Stock-based compensation ( 1.5 ) ( 4.2 ) ( 2.0 )
Change in valuation allowance ( 18.6 ) ( 35.6 ) ( 28.4 )
Other ( 0.1 ) ( 0.1 ) —
Total — % — % — %
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Deferred Tax Assets and Liabilities
Deferred income taxes reflect the net tax effects of loss and credit carryforwards and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the deferred tax assets for federal and state income taxes are as follows (in thousands):
Year ended November 30,
2024 2023
Deferred tax assets:
Net operating loss carryforwards $ 91,786 $ 92,131
Research and development tax credits 48,307 37,052
Deferred revenue 12,683 11,143
Stock-based compensation 5,310 5,472
Accrued expenses and other liabilities 3,199 3,723
Operating lease liabilities 6,125 8,789
Capitalized research and experimental expenses 65,729 44,348
Gross deferred tax assets 233,139 202,658
Valuation allowance ( 227,050 ) ( 193,717 )
Total deferred tax assets 6,089 8,941
Deferred tax liabilities:
Operating lease right-of-use assets ( 6,089 ) ( 8,941 )
Total deferred tax liabilities ( 6,089 ) ( 8,941 )
Net deferred tax assets $ — $ —
Realization of the deferred tax assets is dependent upon future taxable income, the amount, if any, and timing of which are uncertain. The Company has established a valuation allowance to offset deferred tax assets as of November 30, 2024 and 2023 due to the uncertainty of realizing future tax benefits from its NOL carryforwards and other deferred tax assets. The valuation allowance increased by $ 33.3 million to $ 227.1 million during the year ended November 30, 2024, primarily related to an increase on the deferred tax asset for research and development (R&D) credits, NOL carryforwards and Section 174 research and development capitalization. The valuation allowance increased by $ 55.4 million to $ 193.7 million during the year ended November 30, 2023, primarily related to an increase on the deferred tax asset for R&D credits, NOL carryforwards and Section 174 research and development capitalization.
As of November 30, 2024, the Company had NOL carryforwards available to reduce future taxable income, if any, for federal and state income tax purposes of $ 263.9 million and $ 418.7 million, respectively. All outstanding federal NOL carryforwards were generated for tax years beginning after December 31, 2017, and carry forward indefinitely. State NOL carryforwards begin expiring in 2029. As of November 30, 2024, the Company had federal and state research credit carryforwards of $ 44.3 million and $ 25.9 million, respectively. If not utilized, the federal credit carryforwards will begin expiring in 2035 and the state credits carry forward indefinitely.
Section 382 of the Internal Revenue Code of 1986, as amended (IRC) places a limitation on the utilization of NOL and tax credit carryforwards in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50 percentage points. The Company has identified ownership changes that have triggered a limitation on pre-change NOLs under Section 382. A majority of the Company’s pre-change NOLs remain available within the carryforward period provided by the IRC, subject to availability of taxable income.
Unrecognized Tax Benefits
The Company has recorded a liability related to uncertain tax positions in the consolidated financial statements. The Company has unrecognized tax benefits of $ 21.9 million as of November 30, 2024, all of which are offset by a full valuation allowance. There are no tax benefits included in the balance of unrecognized tax benefits that, if recognized, would affect the effective tax rate. There are no interest and penalties accrued as of November 30, 2024.
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A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the years ended November 30, 2024, 2023 and 2022 is as follows (in thousands):
Years ended November 30,
2024 2023 2022
Balance at beginning of period $ 15,508 $ 10,261 $ 6,331
Additions based on tax positions related to current period 6,358 5,247 3,930
Balance at end of period $ 21,866 $ 15,508 $ 10,261
The Company files income tax returns in the United States and in various states. In January 2019, the California Franchise Tax Board (FTB) initiated an examination of the Company’s California tax return for tax years ending in 2015, 2016, 2017 and 2018. During the year ended November 30, 2021, the FTB issued proposed audit assessments related to revenue sourcing and R&D credits. The Company did not agree with the FTB’s assessments and challenged the assessments. Pursuant to a measurement analysis, the Company has not recorded an unrecognized tax benefit related to the FTB’s sourcing position. The Company maintains an unrecognized tax benefit related to its California R&D credits for all years. All of the Company’s tax years will remain open for examination by the federal and state authorities for three and four years , respectively, from the date of the utilization of any NOLs.
In December 2017, the Tax Cuts and Jobs Act (TCJA) was signed into law, significantly reforming the IRC. The TCJA contains a provision impacting Section 174 of the IRC whereby for tax years beginning on or after January 1, 2022, taxpayers are required to capitalize and amortize, rather than deduct, research and experimental (R&E) expenses. The R&E expenses under Section 174 must be amortized over five years for research performed in the United States and 15 years for research performed outside the United States. This rule became effective for the Company during the year ended November 30, 2023. For the years ended November 30, 2024 and 2023, the Company recorded a deferred tax asset of $ 65.7 million and $ 44.3 million, respectively, pursuant to the provisions of Section 174 of the IRC.
11. Net Loss Per Share
The following table sets forth the computation of the Company’s basic and diluted net loss per share attributable to common stockholders, which excludes shares which are legally outstanding but subject to repurchase by the Company (in thousands, except share and per share data):
Year Ended November 30,
2024 2023 2022
Numerator:
Net loss $ ( 193,569 ) $ ( 143,948 ) $ ( 180,360 )
Denominator:
Weighted-average number of shares outstanding, basic and diluted (1)
67,120,266 54,337,901 48,607,990
Net loss per share, basic and diluted $ ( 2.88 ) $ ( 2.65 ) $ ( 3.71 )
(1)
The shares underlying the pre-funded warrants to purchase shares of the Company’s common stock have been included in the calculation of the weighted-average number of shares outstanding, basic and diluted, for the years ended November 30, 2024, 2023 and 2022.
The following potentially dilutive securities were excluded from the computation of the diluted net loss per share of common stock for the periods presented because their effect would have been anti-dilutive:
Years ended November 30,
2024 2023 2022
Options to purchase common stock issued and outstanding 9,839,454 8,340,968 8,256,957
Options early exercised subject to vesting — 4,909 22,246
Restricted stock units issued and outstanding 1,956,015 1,246,031 784,824
Shares expected to be purchased under employee stock purchase plan 71,541 203,314 123,194
Total 11,867,010 9,795,222 9,187,221
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12. Related Party Transactions
The Company’s Chief Financial Officer is a trustee for the multiple employer welfare association that facilitates the acquisition and administration of the Company’s healthcare plans. Expenses related to the healthcare plan premiums were $ 4.3 million, $ 4.4 million and $ 4.0 million for the years ended November 30, 2024, 2023 and 2022, respectively. As of November 30, 2024 and 2023, the amount recorded in accounts payable and accrued expenses and other current liabilities in connection with this healthcare plan provider was not material.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.