Item 1. Financial Statements
Item 1. Financial Statements
NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
(unaudited)
August 31,
2023 November 30,
2022
Assets
Current assets:
Cash and cash equivalents $ 42,304 $ 64,474
Marketable securities, current 216,548 244,667
Accounts receivable 2,000 —
Prepaid expenses and other current assets 7,097 9,308
Total current assets 267,949 318,449
Marketable securities, non‑current 9,882 63,879
Operating lease right-of-use assets 9,027 12,345
Property and equipment, net 16,581 17,163
Restricted cash 901 901
Other assets 3,855 4,022
Total assets $ 308,195 $ 416,759
Liabilities and stockholdersʼ equity
Current liabilities:
Accounts payable $ 2,187 $ 5,064
Accrued expenses and other current liabilities 21,907 22,428
Operating lease liabilities, current 5,362 5,530
Deferred revenue, current 32,037 37,633
Total current liabilities 61,493 70,655
Operating lease liabilities, net of current portion 2,642 6,434
Deferred revenue, net of current portion 10,243 35,974
Total liabilities 74,378 113,063
Commitments and contingencies (Note 6)
Stockholdersʼ equity:
Preferred stock, $ 0.001 par value— 10,000,000 shares authorized as of August 31, 2023 and November 30, 2022; no shares issued and outstanding as of August 31, 2023 and November 30, 2022
— —
Common stock, $ 0.001 par value— 500,000,000 shares authorized as of August 31, 2023 and November 30, 2022; 48,503,768 and 47,172,299 shares issued and outstanding as of August 31, 2023 and November 30, 2022, respectively
49 47
Additional paid-in capital 738,240 709,220
Accumulated other comprehensive loss ( 1,228 ) ( 4,319 )
Accumulated deficit ( 503,244 ) ( 401,252 )
Total stockholdersʼ equity 233,817 303,696
Total liabilities and stockholdersʼ equity $ 308,195 $ 416,759
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(unaudited)
Three Months Ended
August 31, Nine Months Ended
August 31,
2023 2022 2023 2022
Revenue:
Collaboration revenue $ 18,467 $ 10,791 $ 41,828 $ 31,844
License revenue — — 20,000 —
Total revenue 18,467 10,791 61,828 31,844
Operating expenses:
Research and development 47,856 47,761 139,435 138,391
General and administrative 10,623 9,748 32,122 28,630
Total operating expenses 58,479 57,509 171,557 167,021
Loss from operations ( 40,012 ) ( 46,718 ) ( 109,729 ) ( 135,177 )
Interest and other income, net 3,030 1,009 7,737 1,534
Net loss $ ( 36,982 ) $ ( 45,709 ) $ ( 101,992 ) $ ( 133,643 )
Net loss per share, basic and diluted $ ( 0.68 ) $ ( 0.90 ) $ ( 1.88 ) $ ( 2.85 )
Weighted-average number of shares outstanding, basic and diluted 54,390,859 50,868,542 54,227,491 46,835,776
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(unaudited)
Three Months Ended
August 31, Nine Months Ended
August 31,
2023 2022 2023 2022
Net loss $ ( 36,982 ) $ ( 45,709 ) $ ( 101,992 ) $ ( 133,643 )
Other comprehensive income (loss), net of tax:
Unrealized gain (loss) on available-for-sale marketable securities 675 ( 657 ) 3,091 ( 3,134 )
Total comprehensive loss $ ( 36,307 ) $ ( 46,366 ) $ ( 98,901 ) $ ( 136,777 )
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
(unaudited)
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
Exercise of stock options 117,870 — 424 — — 424
Vesting of early exercised stock options — — 47 — — 47
Issuance under employee stock purchase plan 71,207 — 1,064 — — 1,064
Stock-based compensation — — 6,071 — — 6,071
Unrealized loss on available-for-sale marketable securities — — — ( 1,458 ) — ( 1,458 )
Net loss — — — — ( 42,533 ) ( 42,533 )
Balance as of February 28, 2022 44,853,448 45 571,363 ( 2,066 ) ( 263,425 ) 305,917
Exercise of stock options 173,155 — 432 — — 432
Vesting of restricted stock units 13,465 — — — — —
Vesting of early exercised stock options — — 35 — — 35
Stock-based compensation — — 6,775 — — 6,775
Unrealized loss on available-for-sale marketable securities — — — ( 1,019 ) — ( 1,019 )
Net loss — — — — ( 45,401 ) ( 45,401 )
Balance as of May 31, 2022 45,040,068 45 578,605 ( 3,085 ) ( 308,826 ) 266,739
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 24,147 — 174 — — 174
Vesting of restricted stock units 18,469 — — — — —
Vesting of early exercised stock options — — 32 — — 32
Issuance under employee stock purchase plan 65,097 — 891 — — 891
Stock-based compensation — — 6,988 — — 6,988
Unrealized loss on available-for-sale marketable securities — — — ( 657 ) — ( 657 )
Net loss — — — — ( 45,709 ) ( 45,709 )
Balance as of August 31, 2022 47,147,781 $ 47 $ 700,775 $ ( 3,742 ) $ ( 354,535 ) $ 342,545
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Common stock Additional
paid-in
capital Accumulated
other
comprehensive
income (loss) Accumulated
deficit Total
stockholders’
equity
Shares Amount
Balance as of November 30, 2022 47,172,299 $ 47 $ 709,220 $ ( 4,319 ) $ ( 401,252 ) $ 303,696
Exercise of stock options 8,768 — 28 — — 28
Vesting of restricted stock units 98,571 — — — — —
Vesting of early exercised stock options — — 31 — — 31
Issuance under employee stock purchase plan 165,215 — 1,453 — — 1,453
Stock-based compensation — — 8,505 — — 8,505
Unrealized gain on available-for-sale marketable securities — — — 1,072 — 1,072
Net loss — — — — ( 40,733 ) ( 40,733 )
Balance as of February 28, 2023 47,444,853 47 719,237 ( 3,247 ) ( 441,985 ) 274,052
Exercise of pre-funded warrants 148,497 1 — — — 1
Exercise of stock options 5,597 — 24 — — 24
Vesting of restricted stock units 32,261 — — — — —
Vesting of early exercised stock options — — 31 — — 31
Stock-based compensation — — 8,746 — — 8,746
Unrealized gain on available-for-sale marketable securities — — — 1,344 — 1,344
Net loss — — — — ( 24,277 ) ( 24,277 )
Balance as of May 31, 2023 47,631,208 48 728,038 ( 1,903 ) ( 466,262 ) 259,921
Exercise of pre-funded warrants 568,863 1 — — — 1
Exercise of stock options 101,219 — 927 — — 927
Vesting of restricted stock units 100,729 — — — — —
Vesting of early exercised stock options — — 29 — — 29
Issuance under employee stock purchase plan 101,749 — 776 — — 776
Stock-based compensation — — 8,470 — — 8,470
Unrealized gain on available-for-sale marketable securities — — — 675 — 675
Net loss — — — — ( 36,982 ) ( 36,982 )
Balance as of August 31, 2023 48,503,768 $ 49 $ 738,240 $ ( 1,228 ) $ ( 503,244 ) $ 233,817
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
Nine Months Ended August 31,
2023 2022
Cash flows from operating activities
Net loss $ ( 101,992 ) $ ( 133,643 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 5,599 3,730
Stock-based compensation 25,649 19,834
Net amortization (accretion) of premium (discount) on marketable securities ( 3,453 ) 1,076
Loss on disposal of property and equipment 544 9
Amortization of operating lease right-of-use assets 4,298 4,041
Other — 201
Changes in operating assets and liabilities:
Accounts receivable ( 2,000 ) 6,000
Prepaid expenses and other assets 2,556 ( 2,250 )
Accounts payable ( 3,036 ) 984
Deferred revenue ( 31,327 ) ( 22,344 )
Operating lease liabilities ( 4,940 ) ( 3,679 )
Accrued expenses and other liabilities 48 4,189
Net cash used in operating activities ( 108,054 ) ( 121,852 )
Cash flows from investing activities
Purchases of marketable securities ( 157,941 ) ( 212,455 )
Maturities of marketable securities 246,431 194,324
Purchases of property and equipment ( 5,816 ) ( 9,679 )
Net cash provided by (used in) investing activities 82,674 ( 27,810 )
Cash flows from financing activities
Proceeds from issuances of pre-funded warrants, net of issuance costs — 94,942
Proceeds from issuances of common stock in equity financing, net of issuance costs — 19,400
Proceeds from exercise of stock options and pre-funded warrants 981 1,030
Proceeds from issuance under employee stock purchase plan 2,229 1,955
Net cash provided by financing activities 3,210 117,327
Net decrease in cash, cash equivalents and restricted cash ( 22,170 ) ( 32,335 )
Cash, cash equivalents and restricted cash at beginning of period 65,375 80,792
Cash, cash equivalents and restricted cash at end of period $ 43,205 $ 48,457
Supplemental disclosures of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable and accrued expenses and other liabilities $ 1,054 $ 1,726
Capitalized stock-based compensation related to internal-use software development $ 72 $ —
Vesting of early exercised stock options $ 91 $ 114
Issuance costs related to pre-funded warrants included in accrued expenses and other liabilities $ — $ 183
Deferred issuance costs recognized related to equity financing $ — $ 72
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As of August 31,
2023 2022
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents $ 42,304 $ 47,556
Restricted cash 901 901
Total cash, cash equivalents and restricted cash $ 43,205 $ 48,457
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NURIX THERAPEUTICS, INC.
NOTES TO UNAUDITED CONDENSED 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 medicines based on the modulation of cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging the Company’s expertise in E3 ligases together with its proprietary DNA-encoded libraries, the Company has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate 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. (Seagen), 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. This shelf registration statement, which includes a base prospectus, allows the Company at any time 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 may 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 is 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 % 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 $ 10.0001 per share of common stock for net proceeds of $ 19.3 million, after deducting offering commissions and expenses paid by the Company. As of August 31, 2023, the Company had $ 130.0 million of common stock remaining available for sale under the 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. 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 pre-funded warrants issued in the RDOs.
Liquidity and Management Plans
As of August 31, 2023, the Company had cash, cash equivalents and short-term marketable securities of $ 258.9 million and an accumulated deficit of $ 503.2 million. 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.
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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 condensed 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 Gilead, Sanofi and Seagen 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.
2. Summary of Significant Accounting Policies
Basis of Presentation
The Company’s condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and applicable rules and regulations of the SEC regarding interim financial reporting. The Company’s condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair statement of the Company’s financial position as of and for the three and nine months ended August 31, 2023. The condensed consolidated balance sheet as of November 30, 2022, was derived from the audited annual financial statements as of that date. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. These interim financial statements and related disclosures have been prepared with the presumption that users of the interim financial statements have read or have access to the audited annual financial statements for the preceding fiscal year. Accordingly, these financial statements should be read in conjunction with the audited annual financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended November 30, 2022, as filed with the SEC. These interim results are not necessarily indicative of results to be expected for the full fiscal year or any future interim period. Certain prior year amounts have been reclassified for consistency with the current year cash flow presentation. The reclassification did not impact total cash flow from operating, investing or financing activities.
Principles of Consolidation
The accompanying condensed consolidated financial statements 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.
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 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.
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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 invests its cash equivalents in highly rated money market funds. The Company’s marketable securities consist of debt securities issued by highly rated corporate entities, foreign governments, the U.S. federal government or state and local governments. The Company’s exposure to any individual corporate entity is limited by policy, and its ongoing cash management strategy is to maintain diversity in its deposit accounts across financial institutions; however, the Company is exposed to credit risk on deposits in the event of default by the financial institutions to the extent account balances exceed the amount insured by the Federal Deposit Insurance Corporation (FDIC). The Company is closely monitoring ongoing events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, including Silicon Valley Bank (SVB). As of March 27, 2023, in connection with the closure of SVB by the California Department of Financial Protection and Innovation and the FDIC, First-Citizens Bank & Trust Company assumed all of SVB’s deposits and loans. Prior to SVB’s closure, the Company maintained with SVB an operating account with a cash balance of less than 1 % of the Company’s total cash, cash equivalents and marketable securities. In light of the foregoing, the Company does not believe that it has exposure to loss as a result of SVB’s receivership. During the periods presented, the Company has not experienced any realized 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, increasing interest rates, uncertainty with respect to the federal budget and debt ceiling, 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 financial statements and accompanying notes. The extent to which the increasing financial market volatility and uncertainty may directly or indirectly impact the Company’s 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.
Leases
The Company determines if an arrangement contains a lease at inception. Lease right-of-use (ROU) assets, current lease liabilities and long-term 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 lease incentives received. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company’s leases generally do not provide an implicit rate. The incremental borrowing rate, the ROU asset and the lease liability are reevaluated upon a lease modification. The Company determines its incremental borrowing rate based on the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, in an amount equal to the lease payments in a similar economic environment. Lease terms may include options to extend or terminate the lease when the Company is reasonably certain that the option will be exercised. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company does not have any finance leases.
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The Company elected to apply each of the practical expedients described in Topic 842 which allow companies (i) not to reassess prior conclusions on whether any expired or existing contracts are or contain a lease, lease classification, and initial direct costs, (ii) combine lease and non-lease components for all underlying assets groups, and (iii) 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.
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.
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.
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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.
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 condensed 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.
Recently Adopted Accounting Pronouncements
There have been no recent accounting pronouncements, changes in accounting pronouncements or recently adopted accounting guidance during the nine months ended August 31, 2023 that are of significance or potential significance to the Company.
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 DELigase 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 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.
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.
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 August 31, 2023, the Company has received payments of $ 41.0 million for research milestones and additional payments. Additionally, the Company achieved a research milestone in August 2023 and received a payment of $ 6.0 million in the fourth fiscal quarter of 2023. As of August 31, 2023, the Company is eligible to receive up to approximately $ 2.3 billion in total additional payments based on certain additional fees, payments and the successful completion of certain preclinical, clinical, development and 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 Company and Gilead share profits and losses evenly.
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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 Gilead Agreement 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 contract term of five years .
For the three and nine months ended August 31, 2023, the Company recognized collaboration revenue related to the Gilead Agreement of $ 11.6 million and $ 24.7 million, respectively, of which $ 6.6 million and $ 15.1 million, respectively, was included in deferred revenue as of November 30, 2022, and $ 4.7 million and $ 8.0 million, respectively, 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 nine months ended August 31, 2023. For the three and nine months ended August 31, 2022, the Company recognized collaboration revenue related to the Gilead Agreement of $ 7.2 million and $ 19.5 million, respectively, of which $ 5.6 million and $ 14.3 million, respectively, was included in deferred revenue as of November 30, 2021, and $ 0.6 million and $ 4.1 million, respectively, was related to activities satisfied in previous periods. As of August 31, 2023, deferred revenue related to the Gilead Agreement was $ 9.2 million, all of which was current and includes $ 6.0 million in contract assets representing the unbilled amount related to the research milestone achieved in August 2023. As of November 30, 2022, deferred revenue related to the Gilead Agreement was $ 27.4 million, of which $ 18.2 million was included as deferred revenue, 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 DELigase platform to identify small molecules designed to induce degradation of three specified initial drug targets. In January 2021, as part of the existing collaboration agreement, Sanofi paid the Company $ 22.0 million to exercise its option to expand the number of targets in the collaboration agreement from three to a total of five targets.
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). Over time and subject to certain limitations, Sanofi may elect to replace the drug targets with other reserved targets. 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 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, the Company entered into the Fourth Amendment to the Sanofi Agreement to modify the research plan for a certain target, which had no impact on revenue recognition.
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 August 31, 2023, the Company has received payments of $ 5.0 million for research milestones. Additionally, the Company achieved a research milestone in August 2023 and received a payment of $ 2.0 million in the fourth fiscal quarter of 2023. As of August 31, 2023, the Company is eligible to receive up to approximately $ 2.5 billion in total additional payments based on certain additional fees, payments and the successful completion of certain research development, regulatory and sales milestones, as well as 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.
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, $ 7.0 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.
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For the three and nine months ended August 31, 2023, the Company recognized collaboration revenue related to the Sanofi Agreement of $ 6.8 million and $ 17.1 million, respectively, of which $ 5.6 million and $ 15.4 million, respectively, was included in deferred revenue as of November 30, 2022, and $ 1.1 million and $ 1.1 million, respectively, was related to activities satisfied in previous periods. For the three and nine months ended August 31, 2022, the Company recognized collaboration revenue related to the Sanofi Agreement of $ 3.6 million and $ 12.4 million, respectively, of which $ 3.6 million and $ 11.8 million, respectively, was included in deferred revenue as of November 30, 2021 and zero and $ 0.4 million, respectively, was related to activities satisfied in previous periods. As of August 31, 2023, deferred revenue related to the Sanofi Agreement was $ 33.1 million, of which $ 22.8 million was included as deferred revenue, current. Additionally, as of August 31, 2023, $ 2.0 million was recorded in accounts receivable representing the billed amount related to the research milestone achieved in August 2023. As of November 30, 2022, deferred revenue related to the Sanofi Agreement was $ 46.2 million, of which $ 19.4 million was included as deferred revenue, current, and includes $ 1.0 million in contract assets representing the unbilled amount related to the research milestone recognized in November 2022.
Seagen
In September 2023, the Company entered into a strategic collaboration with Seagen (the Seagen Agreement) to develop a suite of targeted protein degraders against multiple targets nominated by Seagen that are suitable for antibody conjugation. Seagen 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. Subject to earlier expiration in certain circumstances, the Seagen Agreement expires on a licensed product-by-licensed product and country-by-country basis upon on the later of (i) the expiration of the last-to-expire patent with a valid claim covering the applicable licensed product in the applicable country, (ii) the expiration of any regulatory exclusivity for the applicable licensed product in the applicable country or (iii) ten years after the first commercial sale of the applicable licensed product in the applicable country covered by the Seagen Agreement. If Seagen does not exercise an option to license a product, then the Seagen Agreement will terminate at the end of the last-to-expire option period.
Under the terms of the Seagen Agreement, the Company received an upfront payment of $ 60.0 million. In addition, the Company is eligible to receive up to approximately $ 3.4 billion in contingent payments based on specified research, development, regulatory and commercial milestones across multiple programs, and is eligible for mid-single to low double digit tiered royalties on future sales. The Company retains an option for U.S. profit sharing and co-promotion on two products arising from the collaboration.
4. Condensed Consolidated Balance Sheet Components
Property and Equipment, Net
Property and equipment, net, consisted of the following (in thousands):
August 31,
2023 November 30,
2022
Laboratory equipment $ 30,752 $ 26,385
Leasehold improvements 3,413 3,825
Computer equipment 897 786
Furniture and fixtures 601 452
Software 5,342 4,688
Software in progress 622 697
Total property and equipment, gross 41,627 36,833
Less: Accumulated depreciation and amortization ( 25,046 ) ( 19,670 )
Total property and equipment, net $ 16,581 $ 17,163
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Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
August 31,
2023 November 30,
2022
Accrued compensation $ 11,534 $ 13,164
Accrued contract research and lab supplies 7,955 6,426
Accrued professional services 1,550 1,250
Accrued taxes 34 85
Other 834 1,503
Total accrued expenses and other current liabilities $ 21,907 $ 22,428
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.
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 August 31, 2023 and November 30, 2022 (in thousands):
August 31, 2023 Level Amortized
cost Unrealized
gain Unrealized
loss Estimated
fair value
Money market funds Level 1 $ 37,928 $ — $ — $ 37,928
U.S. treasury securities Level 1 128,203 2 ( 101 ) 128,104
Corporate debt securities Level 2 14,772 — ( 124 ) 14,648
U.S. government agency securities Level 2 74,688 — ( 892 ) 73,796
Corporate commercial paper Level 2 — — — —
Long-term marketable securities:
U.S. government agency securities Level 2 9,995 — ( 113 ) 9,882
Total $ 265,586 $ 2 $ ( 1,230 ) $ 264,358
Included in cash and cash equivalents $ 37,928 $ — $ — $ 37,928
Included in marketable securities, current $ 217,663 $ 2 $ ( 1,117 ) $ 216,548
Included in marketable securities, non-current $ 9,995 $ — $ ( 113 ) $ 9,882
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November 30, 2022 Level Amortized
cost Unrealized
gain Unrealized
loss Estimated
fair value
Money market funds Level 1 $ 59,452 $ — $ — $ 59,452
U.S. treasury securities Level 1 75,322 — ( 1,120 ) 74,202
Corporate debt securities Level 2 81,026 — ( 1,279 ) 79,747
U.S. government agency securities Level 2 8,998 — ( 135 ) 8,863
Corporate commercial paper Level 2 74,896 — — 74,896
Foreign government securities Level 2 7,051 — ( 92 ) 6,959
Long-term marketable securities:
U.S. treasury securities Level 1 5,779 — ( 98 ) 5,681
Corporate debt securities Level 2 3,492 — ( 217 ) 3,275
U.S. government agency securities Level 2 56,301 1 ( 1,379 ) 54,923
Total $ 372,317 $ 1 $ ( 4,320 ) $ 367,998
Included in cash and cash equivalents $ 59,452 $ — $ — $ 59,452
Included in marketable securities, current $ 247,293 $ — $ ( 2,626 ) $ 244,667
Included in marketable securities, non-current $ 65,572 $ 1 $ ( 1,694 ) $ 63,879
The accrued interest receivable related to the Company’s marketable securities was $ 0.8 million and $ 1.1 million as of August 31, 2023 and November 30, 2022, respectively, and was included in prepaid expenses and other current assets on the condensed 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.
The Company classifies its marketable securities in corporate debt securities, U.S. government agency securities, corporate commercial paper and foreign government 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 three and nine months ended August 31, 2023 and 2022.
As of August 31, 2023 and November 30, 2022, the unrealized losses for available-for-sale 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 August 31, 2023 and November 30, 2022, no allowance for credit losses for the Company’s marketable securities was recorded. During the three and nine months ended August 31, 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 August 31, 2023, the Company was not a party to any material legal proceedings.
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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 condensed 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 Company’s condensed 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 on April 30, 2025.
In July 2021, and as subsequently amended in June 2023, the Company entered into a lease agreement for the lease of approximately 19,320 square feet of office space in San Francisco, California, for a research and development laboratory and related uses. The lease will expire on June 30, 2024, unless terminated earlier.
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, for a research and development laboratory and related uses. In August 2023, the lease agreement was amended to increase the square footage of the leased premise to 50,094 square feet. The Company obtained access to the premise on August 1, 2022 to commence construction of landlord-owned improvements. The lease commenced in September 2023 when the underlying assets became available for use and the Company obtained control and will expire on March 1, 2035, unless terminated earlier. The Company has an option to renew for two additional terms of five years each, and it is not reasonably certain that the Company will exercise this option. Pursuant to the terms of the lease agreement, the minimum rent payable by the Company under the lease will be approximately $ 154,000 per month for the period between March 1, 2023 and February 29, 2024, and approximately $ 211,000 per month thereafter; provided that the minimum rent payable by the Company will increase by 3 % per year over the term of the lease. The Company will also be responsible for the payment of its proportionate share of the operating expenses as defined in the lease agreement.
Operating lease expenses, excluding additional rent charges for utilities, maintenance and real estate taxes, were $ 1.5 million for each of the three months ended August 31, 2023 and 2022, and $ 4.5 million and $ 4.4 million for the nine months ended August 31, 2023 and 2022, respectively. Short-term lease expense was not material for all periods presented.
Other information related to leases were as follows (in thousands):
Nine Months Ended August 31,
2023 2022
Cash paid for amounts included in the measurement of lease liabilities:
Cash flows from operating leases $ 4,182 $ 5,198
Supplemental disclosures of non-cash investing and financing activities:
Right-of-use assets recognized in exchange for lease obligations $ — $ 5,060
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 August 31, 2023 and November 30, 2022. 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 August 31, 2023, no dividends have been declared.
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In July 2022, the Company issued pre-funded warrants to purchase an aggregate of 6,814,920 shares of the Company’s common stock in RDOs at a price of $ 13.939 per pre-funded warrant. The pre-funded warrants were immediately exercisable, 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. As of August 31, 2023, there were pre-funded warrants to purchase an aggregate of 6,097,560 shares of the Company's common stock that remained available for exercise.
The pre-funded warrants were classified as a component of permanent equity in the Company's condensed 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 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 August 31, 2023 and November 30, 2022, consists of the following:
August 31,
2023 November 30,
2022
Options to purchase common stock issued and outstanding 8,487,135 8,256,957
Restricted stock units issued and outstanding 1,434,888 784,824
Shares available for future equity grants 1,493,795 834,291
Shares available for issuance under employee stock purchase plan 1,530,281 1,325,523
Pre-funded warrants issued and outstanding 6,097,560 6,814,920
Total common stock reserved for future issuance 19,043,659 18,016,515
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, restricted stock units (RSUs), performance awards and stock bonus awards to employees, directors, consultants, independent contractors and advisors of the Company.
Option activity under the Stock Plans is set forth below:
Number of
options
outstanding Weighted-
average
exercise
price
Balances as of November 30, 2022 8,256,957 $ 19.47
Options granted 1,857,700 10.55
Options exercised ( 115,584 ) 8.47
Options forfeited ( 1,511,938 ) 21.75
Balances as of August 31, 2023 8,487,135 $ 17.26
RSU activity under the Stock Plans is set forth below:
Number of RSUs Weighted-average grant date fair value
Balances as of November 30, 2022 784,824 $ 18.97
RSUs granted 1,053,915 10.74
RSUs vested ( 231,561 ) 16.10
RSUs forfeited ( 172,290 ) 14.35
Balances as of August 31, 2023 1,434,888 $ 13.94
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Employee Stock Purchase Plan
Under the Company’s 2020 Employee Stock Purchase Plan (the ESPP), eligible employees are entitled to purchase shares of common stock with accumulated payroll deductions. During the nine months ended August 31, 2023, the Company issued 266,964 shares of common stock pursuant to the ESPP at a weighted-average price of $ 8.35 per share.
Stock-Based Compensation
Stock-based compensation expense related to the Stock Plans and the ESPP that is included in the Company’s condensed consolidated statements of operations is as follows (in thousands):
Three Months Ended,
August 31, Nine Months Ended
August 31,
2023 2022 2023 2022
Research and development $ 4,552 $ 4,229 $ 14,565 $ 11,766
General and administrative 3,893 2,759 11,084 8,068
Total stock-based compensation $ 8,445 $ 6,988 $ 25,649 $ 19,834
As of August 31, 2023, the total compensation cost related to stock-based awards not yet recognized was $ 62.8 million, which is expected to be amortized on a straight-line basis over the weighted-average remaining vesting period of approximately 2.2 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 $ 0.2 million and $ 0.1 million during the three months ended August 31, 2023 and 2022, respectively, and $ 1.0 million and $ 0.8 million during the nine months ended August 31, 2023 and 2022, respectively.
10. Income Taxes
For the three and nine months ended August 31, 2023 and 2022, the Company did not record any current income tax expense or provision. 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. 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 generated losses since inception and has established a valuation allowance to offset deferred tax assets as of August 31, 2023 and 2022 due to the uncertainty of realizing future tax benefits from its net operating loss carryforwards and other deferred tax assets.
Under an Organization for Economic Co-operation and Development Inclusive Framework, more than 140 countries agreed to enact a two-pillar solution to address the challenges arising from the digitalization of the world economy (Pillar Two). Pillar Two introduces a global minimum Effective Tax Rate (ETR) via a system where multinational groups with consolidated revenue over €750M are subject to a minimum ETR of 15% on income arising in low-tax jurisdictions. Rules under Pillar Two are expected to be enacted beginning January 1, 2024. The Company will continue to monitor the impact of Pillar Two; however, the Company has minimal international activity and is not expecting Pillar Two to have an impact on its condensed consolidated financial statements.
In January 2019, the California Franchise Tax Board (FTB) initiated an examination of the Company’s California tax return for the 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 does not agree with the FTB assessments and intends to challenge 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.
In December 2017, the Tax Cuts and Jobs Act (TCJA) was signed into law, significantly reforming the Internal Revenue Code of 1986, as amended (IRC). The TCJA included a provision impacting Section 174 that requires taxpayers to capitalize and amortize, rather than deduct, research and experimental (R&E) expenses for tax years beginning on or after January 1, 2022. For the year ending November 30, 2023, the Company anticipates capitalizing a significant portion of its total R&E expenses. The Company does not expect a significant current income tax liability as a result of the enactment of IRC Section 174. The Company will continue to monitor IRS guidance on this provision.
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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):
Three Months Ended
August 31, Nine Months Ended
August 31,
2023 2022 2023 2022
Numerator:
Net loss $ ( 36,982 ) $ ( 45,709 ) $ ( 101,992 ) $ ( 133,643 )
Denominator:
Weighted-average number of shares outstanding, basic and diluted (1)
54,390,859 50,868,542 54,227,491 46,835,776
Net loss per share, basic and diluted $ ( 0.68 ) $ ( 0.90 ) $ ( 1.88 ) $ ( 2.85 )
(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 three and nine months ended August 31, 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:
August 31,
2023 2022
Options to purchase common stock issued and outstanding 8,487,135 8,115,201
Options early exercised subject to vesting 7,643 27,424
Restricted stock units issued and outstanding 1,434,888 753,518
Shares expected to be purchased under employee stock purchase plan 203,314 123,194
Total 10,132,980 9,019,337
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 $ 1.1 million and $ 1.0 million for the three months ended August 31, 2023 and 2022, respectively, and $ 3.3 million and $ 2.9 million for the nine months ended August 31, 2023 and 2022, respectively. As of August 31, 2023 and November 30, 2022, the amount recorded in accounts payable and accrued expenses and other current liabilities in connection with this healthcare plan provider was not material.
13. Subsequent Events
Refer to Note 3 for more information on the Seagen Agreement.
Refer to Note 6 for more information on the commencement of the lease in The Woodlands, Texas.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.