Document and Entity Information
Document and Entity Information - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 22, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Entity Registrant Name | FATE THERAPEUTICS, INC. | ||
Entity Central Index Key | 0001434316 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2022 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Interactive Data Current | Yes | ||
Entity Shell Company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Trading Symbol | FATE | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Security Exchange Name | NASDAQ | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Public Float | $ 2,340,000,000 | ||
Entity Common Stock, Shares Outstanding | 98,161,823 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Tax Identification Number | 65-1311552 | ||
Entity File Number | 001-36076 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 12278 Scripps Summit Drive | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92131 | ||
City Area Code | 858 | ||
Local Phone Number | 875-1800 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission, or SEC, on or before the date 120 days after the conclusion of the registrant’s fiscal year ended December 31, 2022 pursuant to Regulation 14A in connection with the registrant’s 2023 Annual Meeting of Stockholders are incorporated by reference into Part III of this annual report on Form 10-K. | ||
Auditor Name | Ernst & Young, LLP | ||
Auditor Location | San Diego, CA | ||
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 61,333 | $ 133,583 |
Accounts receivable | 38,480 | 8,676 |
Short-term investments | 374,894 | 482,327 |
Prepaid expenses and other current assets | 27,367 | 8,826 |
Total current assets | 502,074 | 633,412 |
Long-term investments | 4,942 | 100,664 |
Property and equipment, net | 110,020 | 91,529 |
Operating lease right-of-use assets | 66,069 | 70,720 |
Restricted cash | 15,227 | 15,227 |
Collaboration contract assets | 7,196 | 9,870 |
Other assets | 33 | 33 |
Total assets | 705,561 | 921,455 |
Current liabilities: | ||
Accounts payable | 8,265 | 8,612 |
Accrued expenses | 53,932 | 42,412 |
CIRM award liability, current portion | 4,000 | 3,200 |
Deferred revenue, current portion | 42,226 | 21,483 |
Operating lease liabilities, current portion | 5,628 | 5,577 |
Total current liabilities | 114,051 | 81,284 |
Deferred revenue, net of current portion | 0 | 27,124 |
CIRM award liability, net of current portion | 0 | 800 |
Operating lease liabilities, net of current portion | 103,710 | 109,241 |
Stock price appreciation milestones, net of current portion | 3,861 | 24,168 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; authorized shares--5,000,000 at December 31, 2022 and December 31, 2021; Class A Convertible Preferred shares issued and outstanding--2,794,549 at December 31, 2022 and December 31, 2021 | 3 | 3 |
Common stock, $0.001 par value; authorized shares--250,000,000 at December 31, 2022 and December 31, 2021; issued and outstanding --97,294,917 at December 31, 2022 and 95,726,962 at December 31, 2021 | 97 | 96 |
Additional paid-in capital | 1,536,497 | 1,448,584 |
Accumulated other comprehensive (loss) gain | (1,854) | (762) |
Accumulated deficit | (1,050,804) | (769,083) |
Total stockholders’ equity | 483,939 | 678,838 |
Total liabilities and stockholders’ equity | $ 705,561 | $ 921,455 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized shares | 250,000,000 | 250,000,000 |
Common stock, issued shares | 97,294,917 | 95,726,962 |
Common stock, outstanding shares | 97,294,917 | 95,726,962 |
Class A Convertible Preferred Shares | ||
Preferred stock, issued shares | 2,794,549 | 2,794,549 |
Preferred stock, outstanding shares | 2,794,549 | 2,794,549 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | |||
Collaboration revenue | $ 96,300 | $ 55,846 | $ 31,434 |
Type of Revenue [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | |||
Research and development | $ 320,454 | $ 215,519 | $ 125,623 |
General and administrative | 84,232 | 57,321 | 33,896 |
Total operating expenses | 404,686 | 272,840 | 159,519 |
Loss from operations | (308,386) | (216,994) | (128,085) |
Other income (expense): | |||
Interest income | 5,842 | 1,309 | 2,400 |
Change in fair value of stock price appreciation milestones | 20,307 | 3,534 | (47,702) |
Other income | 516 | 0 | 0 |
Total other income (expense), net | 26,665 | 4,843 | (45,302) |
Net loss | (281,721) | (212,151) | (173,387) |
Other comprehensive loss: | |||
Unrealized (loss) gain on available-for-sale securities, net | (1,092) | (832) | 48 |
Comprehensive loss | $ (282,813) | $ (212,983) | $ (173,339) |
Earnings Per Share, Basic | $ (2.91) | $ (2.24) | $ (2.10) |
Earnings Per Share Diluted | $ (2.91) | $ (2.24) | $ (2.10) |
Weighted Average Number of Shares Outstanding, Basic | 96,826,058 | 94,747,311 | 82,385,319 |
Weighted Average Number of Shares Outstanding, Diluted | 96,826,058 | 94,747,311 | 82,385,319 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit | Convertible Preferred Stock Preferred Stock [Member] |
Balance at Dec. 31, 2019 | $ 244,756 | $ 76 | $ 628,200 | $ 22 | $ (383,545) | $ 3 |
Balance (in shares) at Dec. 31, 2019 | 75,730,260 | 2,794,549 | ||||
Exercise of stock options, net of issuance costs | 9,582 | $ 1 | 9,581 | |||
Exercise of stock options, net of issuance costs (in shares) | 1,419,117 | |||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 85,000 | |||||
Stock–based compensation | 30,753 | 30,753 | ||||
Public offering of common stock, net of offering costs | 188,784 | $ 7 | 188,777 | |||
Public offerings of common stock, net of offering costs (in shares) | 7,108,796 | |||||
Private placement of common stock, net of issuance costs | 49,975 | $ 2 | 49,973 | |||
Private placement of common stock, net of issuance costs (in shares) | 1,766,160 | |||||
Issuance of stock to collaboration partner, net of issuance costs | 33,934 | $ 2 | 33,932 | |||
Issuance of stock to collaboration partner, net of issuance costs (in shares) | 1,612,904 | |||||
Unrealized loss on investments, net | 48 | 48 | ||||
Net loss | (173,387) | (173,387) | ||||
Balance at Dec. 31, 2020 | 384,445 | $ 88 | 941,216 | 70 | (556,932) | $ 3 |
Balance (in shares) at Dec. 31, 2020 | 87,722,237 | 2,794,549 | ||||
Exercise of stock options, net of issuance costs | 20,730 | $ 2 | 20,728 | |||
Exercise of stock options, net of issuance costs (in shares) | 2,430,298 | |||||
Issuance of common stock upon vesting of restricted stock units | 1 | $ 1 | ||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 451,620 | |||||
Stock–based compensation | 54,364 | 54,364 | ||||
Public offering of common stock, net of offering costs | 432,281 | $ 5 | 432,276 | |||
Public offerings of common stock, net of offering costs (in shares) | 5,122,807 | |||||
Unrealized loss on investments, net | (832) | (832) | ||||
Net loss | (212,151) | (212,151) | ||||
Balance at Dec. 31, 2021 | 678,838 | $ 96 | 1,448,584 | (762) | (769,083) | $ 3 |
Balance (in shares) at Dec. 31, 2021 | 95,726,962 | 2,794,549 | ||||
Exercise of stock options, net of issuance costs | $ 9,181 | $ 1 | $ 9,180 | |||
Exercise of stock options, net of issuance costs (in shares) | 941,780 | |||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 626,175 | |||||
Stock–based compensation | $ 78,733 | $ 78,733 | ||||
Unrealized loss on investments, net | (1,092) | (1,092) | ||||
Net loss | (281,721) | (281,721) | ||||
Balance at Dec. 31, 2022 | $ 483,939 | $ 97 | $ 1,536,497 | $ (1,854) | $ (1,050,804) | $ 3 |
Balance (in shares) at Dec. 31, 2022 | 97,294,917 | 2,794,549 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities: | |||
Net loss | $ (281,721) | $ (212,151) | $ (173,387) |
Adjustments to reconcile net loss to net cash used in operating activities | |||
Depreciation and amortization | 13,758 | 5,850 | 3,087 |
Stock-based compensation | 78,733 | 54,364 | 30,753 |
Accretion and amortization of premiums and discounts on investments, net | (256) | 5,067 | 1,676 |
Amortization of collaboration contract asset | 2,676 | 3,995 | 3,110 |
Deferred revenue | (6,381) | (18,559) | 60,603 |
Change in fair value of stock price appreciation milestones | (20,307) | (3,534) | 47,702 |
Changes in assets and liabilities: | |||
Accounts receivable | (29,804) | (3,160) | (5,515) |
Prepaid expenses and other assets | (18,330) | (3,052) | (13,582) |
Accounts payable and accrued expenses | 14,252 | 5,907 | (1,554) |
Right-of-use assets and lease liabilities, net | (828) | 2,403 | 7,878 |
Net cash used in operating activities | (248,208) | (162,870) | (39,229) |
Investing activities | |||
Purchases of property and equipment | (35,566) | (50,704) | (4,932) |
Purchases of investments | (404,796) | (968,159) | (277,344) |
Maturities of investments | 607,113 | 694,840 | 121,200 |
Net cash provided by (used in) investing activities | 166,751 | (324,023) | (161,076) |
Financing activities | |||
Issuance of common stock from equity incentive plans, net of issuance costs | 9,207 | 20,714 | 9,655 |
Proceeds from public offering of common stock, net of issuance costs | 0 | 411,735 | 188,784 |
Proceeds from issuance of pre-funded warrants, net of issuance costs | 0 | 20,680 | 0 |
Proceeds from private placement of common stock, net of issuance costs | 0 | 0 | 49,975 |
Proceeds from sale of common stock to collaboration partner, net of issuance costs | 0 | 0 | 33,934 |
Proceeds from CIRM award | 0 | 0 | 490 |
Net cash provided by financing activities | 9,207 | 453,129 | 282,838 |
Net change in cash, cash equivalents and restricted cash | (72,250) | (33,764) | 82,533 |
Cash, cash equivalents and restricted cash at beginning of the year | 148,810 | 182,574 | 100,041 |
Cash, cash equivalents and restricted cash at end of the year | 76,560 | 148,810 | 182,574 |
Supplemental schedule of noncash investing and financing activities | |||
Purchases of property and equipment in accounts payable | 1,055 | 4,371 | 1,486 |
Right-of-use assets obtained in exchange for lease obligations | 682 | 8,600 | 49,287 |
Accrued issuance costs included in additional paid-in-capital | $ 0 | $ 133 | $ 0 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization Fate Therapeutics, Inc. (the Company) was incorporated in the state of Delaware on April 27, 2007 and has its principal operations in San Diego, California. The Company is a clinical-stage biopharmaceutical company dedicated to bringing off-the-shelf, multiplexed-engineered, iPSC-derived natural killer (NK) and T-cell product candidates to patients for the treatment of cancer and autoimmune disease. As of December 31, 2022, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure and has not generated any revenues from any sales of its therapeutic products. To date, the Company’s revenues have been derived from collaboration agreements and government grants. Public Equity Offerings In January 2021, the Company completed a public offering of common stock in which investors, certain of which are affiliated with a director of the Company, purchased 5.1 million shares of the Company’s common stock at a price of $ 85.50 per share under a shelf registration statement. In addition, the Company issued pre-funded warrants, in lieu of common stock to certain investors, to purchase 257,310 shares of the Company’s common stock (Pre-Funded Warrants). The purchase price of the Pre-Funded Warrants was $ 85.499 per Pre-Funded Warrant, which equals the per share public offering price for the shares of common stock less the $ 0.001 exercise price for each such Pre-Funded Warrant. See Note 9 for additional detail. Gross proceeds from the public offering and the issuance of the Pre-Funded Warrants were $ 460.0 million, and after giving effect to $ 27.6 million of costs related to the public offering and the issuance of Pre-Funded Warrants, net proceeds were $ 432.4 million. In June 2020, the Company completed a public offering of common stock in which investors, certain of which are affiliated with a director of the Company, purchased 7.1 million shares of its common stock at a price of $ 28.31 per share under a shelf registration statement. Gross proceeds from the offering were $ 201.3 million, and after giving effect to $ 12.5 million of costs related to the offering, net proceeds were $ 188.8 million. Private Placements of Common Stock In June 2020, in connection with the June 2020 public offering of common stock, the Company exercised its right to cause an existing shareholder, Johnson & Johnson Innovation-JJDC, Inc (JJDC), to purchase $ 50.0 million of the Company’s common stock, and JJDC purchased in a private placement 1.8 million shares of the Company’s common stock at a price of $ 28.31 per share, for aggregate proceeds of $ 50.0 million. In April 2020, in connection with the Janssen Agreement described in Note 2, JJDC purchased in a private placement 1.6 million shares of the Company’s common stock at a price of $ 31.00 per share, for aggregate proceeds of $ 50.0 million. The shares of common stock purchased in the private placements were not subject to any underwriting discounts or commissions. Use of Estimates The Company’s consolidated financial statements are prepared in accordance with United States generally accepted accounting principles (U.S. GAAP). The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to its stock appreciation milestone obligations, contracts containing leases, and accrued expenses. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Risks and Uncertainties Due to the global outbreak of SARS-CoV-2, the strain of coronavirus that causes Coronavirus disease 19 (COVID-19), including the emergence of new variants of the virus, the Company experienced impacts on certain aspects of its business, including its clinical trial and research and development activities, during the year ended December 31, 2022 . For example, the Company implemented in response to governmental “stay at home” orders and in the interests of public health and safety, and the Company has experienced delays or disruptions in the initiation and conduct of its clinical trials as a result of prioritization of hospital and other medical resources toward pandemic efforts, policies and procedures implemented at clinical sites with respect to the conduct of clinical trials, and other precautionary measures taken in treating patients or in practicing medicine in response to the COVID-19 pandemic. The scope and duration of these delays and disruptions, and the ultimate impacts of COVID-19 on the Company’s operations, are currently unknown. The Company is continuing to actively monitor the situation and may take further precautionary and preemptive actions as may be required by federal, state or local authorities or that it determines are in the best interests of public health and safety and that of the Company’s patient community, employees, partners, and stockholders. The Company cannot predict the effects that such actions, or the impact of COVID-19 on global business operations and economic conditions, may have on its business, strategy, collaborations, or financial and operating results. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its subsidiaries. To date, the aggregate operations of these subsidiaries have not been significant and all intercompany transactions and balances have been eliminated in consolidation. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating and reportable segment. Fair Value of Financial Instruments The Company’s financial instruments consist primarily of cash and cash equivalents, marketable securities, accounts receivable, stock price appreciation milestones, accounts payable, and accrued liabilities. The carrying amounts of accounts receivable, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the relatively short-term nature of those instruments. The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three- tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash in readily available checking and savings accounts, money market accounts and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows as of December 31, 2022, 2021 and 2020 (in thousands): Years Ended December 31, 2022 2021 2020 Cash and cash equivalents $ 61,333 $ 133,583 $ 167,347 Restricted cash 15,227 15,227 15,227 Total cash, cash equivalents, and restricted cash shown in the consolidated statement of cash flows $ 76,560 $ 148,810 $ 182,574 For the years ended December 31, 2022, 2021 and 2020 , the restricted cash balance includes cash-collateralized irrevocable standby letters of credit for $ 15.2 million associated with the Company’s facilities leases . Investments Investments are accounted for as available-for-sale securities and are carried at fair value on the consolidated balance sheets. Upon initial recognition of the investment and at each reporting period, the Company evaluates whether any unrealized losses on investments are attributable to a credit loss or other factors. Any unrealized losses attributable to credit loss are recorded through an allowance for credit losses, limited to the amount by which the fair value is below amortized cost, with the offsetting amount recorded in other income or expense in the consolidated statement of operations and comprehensive loss. Unrealized losses not attributable to an expected credit loss and unrealized gains on investments are recorded in other comprehensive income (loss) on the consolidated statements of operations and comprehensive loss. Realized gains and losses, if any, on investments classified as available-for-sale securities are included in other income or expense. The amortized cost of investments classified as available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. Concentration of Credit Risk Financial instruments, which potentially subject the Company to a significant concentration of credit risk, consist primarily of cash and cash equivalents and investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits and investments are held. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally two to five years ) and generally consist of furniture and fixtures, computers, scientific and office equipment, and in-process costs related to facilities construction. Repairs and maintenance costs are charged to expense as incurred. Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. If the carrying amount is not recoverable, the Company measures the amount of any impairment by comparing the carrying value of the asset to the present value of the expected future cash flows associated with the use of the asset. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, management believes that future cash flows to be received support the carrying value of its long-lived assets and, accordingly, has not recognized any impairment losses since inception. Leases The Company determines if a contract contains a lease at the inception of the contract. The Company currently has leases related to its facilities leased for office and laboratory space, which are classified as operating leases. These leases result in operating right-of-use (ROU) assets, current operating lease liabilities, and non-current operating lease liabilities in the Company’s consolidated balance sheets. The Company does not have any financing leases. Leases with a term of 12 months or less are considered short-term and ROU assets and lease obligations are not recognized. Payments associated with short-term leases are expensed on a straight-line basis over the lease term. Lease liabilities represent an obligation to make lease payments arising from the lease and ROU assets represent the right to use the underlying asset identified in the lease for the lease term. Lease liabilities are measured at the present value of the lease payments not yet paid discounted using the discount rate for the lease established at the lease commencement date. To determine the present value, the implicit rate is used when readily determinable. For those leases where the implicit rate is not provided, the Company determines an incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. ROU assets are measured as the present value of the lease payments and also include any prepaid lease payments made and any other indirect costs incurred, and exclude any lease incentives received. Lease terms may include the impact of options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company aggregates all lease and non-lease components for each class of underlying assets into a single lease component. Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements ("ASC 808"), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and its collaboration partner are within the scope of other accounting literature, including ASC Topic 606, Revenue from Contracts with Customers ("ASC 606"). If it is concluded that some or all aspects of the arrangement represent a transaction with a customer, the Company will account for those aspects of the arrangement within the scope of ASC 606. ASC 808 provides guidance for the presentation and disclosure of transactions in collaborative arrangements, but it does not provide recognition or measurement guidance. Therefore, if the Company concludes a counterparty to a transaction is not a customer or otherwise not within the scope of ASC 606, the Company considers the guidance in other accounting literature as applicable or by analogy to account for such transaction. The classification of transactions under the Company’s arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. Revenue Recognition The Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the Company follows a five-step approach for arrangements that are attributable to ASC 606 - Revenues from customers: (i) identify the contract 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, and (v) recognize revenue when (or as) the customer obtains control of the product or service. The Company considers the terms of a contract and all relevant facts and circumstances when applying the revenue recognition standard. The Company applies the revenue recognition standard, including the use of any practical expedients, consistently to contracts with similar characteristics and in similar circumstances. A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product or the service to be transferred can be identified, (iii) the payment terms for the product or the service to be transferred can be identified, (iv) the contract must have commercial substance (that is, the risk, timing or amount of future cash flows is expected to change as a result of the contract), and (v) it is probable that the Company will collect substantially all of the consideration to which it is entitled to receive in exchange for the transfer of the product or the service. A performance obligation is defined as a promise to transfer a product or a service to a customer. The Company identifies each promise to transfer a product or a service (or a bundle of products or services, or a series of products and services that are substantially the same and have the same pattern of transfer) that is distinct. A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract. Each distinct promise to transfer a product or a service is a unit of accounting for revenue recognition. If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation. The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer. To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer. If a significant financing component exists, the transaction price is adjusted for the time value of money. If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer. There are two methods for determining the amount of variable consideration: (i) the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts, and (ii) the mostly likely amount method, which identifies the single most likely amount in a range of possible consideration amounts. If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation. In those instances where the Company first receives consideration in advance of satisfying its performance obligation, the Company classifies such consideration as deferred revenue until (or as) the Company satisfies such performance obligation. In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable. The Company expenses incremental costs of obtaining and fulfilling a contract as and when incurred if the expected amortization period of the asset that would be recognized is one year or less, or if the amount of the asset is immaterial. Otherwise, such costs are capitalized as contract assets if they are incremental to the contract and amortized to expense proportionate to revenue recognition of the underlying contract . Stock Price Appreciation Milestones The Company estimates the fair value of the stock price appreciation milestones associated with the Amended and Restated Exclusive License Agreement with Memorial Sloan Kettering Cancer Center, using a Monte Carlo simulation model, which relies on the Company’s current stock price as well as significant estimates and assumptions to determine the estimated liability associated with the contingent milestone payments. The Company accounts for the fair value of the stock price appreciation milestones in accordance with ASC 815, Derivatives and Hedging , with fair value marked to market at each reporting date. The assumptions used to calculate the fair value of the stock price appreciation milestones are subject to a significant amount of judgment including the probability of achieving a specified clinical milestone, the expected volatility of the Company’s common stock, the risk-free interest rate, and the estimated term, which is based in part on the last valid patent claim date. The Company remeasures the fair value of the stock price appreciation milestones at each balance sheet date, with changes in fair value recorded in earnings as non-operating income or expense on the consolidated statements of operations and comprehensive loss. Research and Development Costs All research and development costs are expensed as incurred. Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain. Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee stock option and restricted stock unit grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. Performance-based stock units/awards represent a right to receive a certain number of shares of common stock based on the achievement of corporate performance goals and continued employment during the vesting period. At each reporting period, and to the extent achievement of one or any of the performance conditions is probable, the Company reassesses the probability of the achievement of such corporate performance goals and any increase or decrease in share-based compensation expense resulting from an adjustment in the estimated shares to be released is treated as a cumulative catch-up in the period of adjustment. For stock awards for which vesting is subject to both performance-based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance-based milestone is probable or the performance condition has been achieved. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, with the exception of option grants for which vesting is subject to both performance-based milestones and market conditions, which are valued using a lattice-based model. The fair value of restricted stock units, including performance-based restricted stock units, is based on the closing price of the Company’s common stock as reported on The Nasdaq Global Market on the date of grant. The Company recognizes forfeitures for all awards as such forfeitures occur . Convertible Preferred Stock The Company applies the relevant accounting standards to distinguish liabilities from equity when assessing the classification and measurement of preferred stock. Preferred shares subject to mandatory redemptions are considered liabilities and measured at fair value. Conditionally redeemable preferred shares are considered temporary equity. All other preferred shares are considered as stockholders’ equity. The Company applies the relevant accounting standards for derivatives and hedging (in addition to distinguishing liabilities from equity) when accounting for hybrid contracts that contain conversion options. Conversion options must be bifurcated from the host instruments and accounted for as free-standing financial instruments according to certain criteria. These criteria include circumstances when (i) the economic characteristics and risks of the embedded derivative instruments are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable accounting principles with changes in fair value reported in earnings as they occurred, and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently measured at fair value at each reporting date, with the changes in fair value reported in earnings. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more- likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. Employee Retention Credit The CARES Act provides an employee retention credit (ERC), which is a refundable tax credit against certain employment taxes of up to $ 5,000 per employee for eligible employers. The tax credit is equal to 50 % of qualified wages paid to employees during a quarter, capped at $ 10,000 of qualified wages per employee through December 31, 2020. Additional relief provisions were passed by the United States government, which extend and slightly expand the qualified wage caps on these credits through December 31, 2021. Based on these additional provisions, the tax credit is now equal to 70 % of qualified wages paid to employees during a quarter, and the limit on qualified wages per employee has been increased to $ 10,000 of qualified wages per quarter. The Company qualifies for the tax credit under the CARES Act and expects to continue to receive additional tax credits under the additional relief provisions for qualified wages through December 31, 2021. In connection with the CARES Act, the Company adopted a policy to recognize the employee retention credit when received and include in other income in the statement of operations. Accordingly, the Company received a cash payment and recorded $ 0.5 million of other income during the year ended December 31, 2022 . The Company did not receive or record other income during the years ended December 31, 2021 or 2020 . Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non‑owner sources. Other comprehensive loss includes unrealized gains and losses, other than losses attributable to a credit loss which are included in other income and expense, on investments classified as available-for-sale securities, which was the only difference between net loss and comprehensive loss for the applicable periods. Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. The Pre-Funded Warrants associated with the January 2021 public equity offering (see Note 9) are considered outstanding shares in the basic earnings per share calculation given their nominal exercise price. Dilutive common stock equivalents comprise convertible preferred stock, warrants for the purchase of common stock, and common stock options and restricted stock units outstanding under the Company’s stock option plans. For all periods presented, there is no difference in the number of common shares used to calculate basic and diluted common shares outstanding due to the Company’s net loss position. Potentially dilutive securities that are not included in the calculation of diluted net loss per common share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): As of December 31, 2022 2021 2020 Common stock options 7,267,226 7,708,263 10,432,822 Restricted stock units 5,862,733 4,008,832 1,401,732 Series A convertible preferred stock (if converted) 13,972,745 13,972,745 13,972,745 Total 27,102,704 25,689,840 25,807,299 Going Concern Assessment Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year from the financial statement issuance date. The Company determined that there are no conditions or events that raise substantial doubt about its ability to continue as a going concern for a period of at least twelve months from the date of issuance of these financial statements . |
Collaboration and License Agree
Collaboration and License Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Collaboration And License Agreements Disclosure [Abstract] | |
Collaboration and License Agreements | 2. Collaboration and License Agreements Janssen Collaboration and Option Agreement On April 2, 2020 (the Janssen Agreement Effective Date), the Company entered into a Collaboration and Option Agreement (the Janssen Agreement) with Janssen Biotech, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Additionally, on the Janssen Agreement Effective Date, the Company entered into a Stock Purchase Agreement (the Stock Purchase Agreement) with JJDC. Upon entering the Janssen Agreement, the Company received an upfront, non-refundable and non-creditable payment of $ 50.0 million. Under the Janssen Agreement, Janssen and the Company will collaborate to develop iPSC-derived CAR NK and CAR T-cell product candidates for the treatment of cancer. Janssen will contribute proprietary antigen binding domains directed to up to four tumor-associated antigen targets (the Janssen Cancer Targets). The Company will research and construct iPSC-derived CAR NK and CAR T-cell product candidates directed to each of the Janssen Cancer Targets (the Collaboration Candidates) and perform preclinical development of Collaboration Candidates. Upon the Company’s completion of activities sufficient to allow the filing of an IND application for a Collaboration Candidate, Janssen will have the right to exercise an exclusive option and obtain an exclusive license to the Company’s intellectual property rights for the development and commercialization for each Collaboration Candidate. Upon the exercise of such exclusive option, Janssen will be solely responsible for the worldwide clinical development and commercialization of such Collaboration Candidate, and the Company will be primarily responsible for the manufacture, at Janssen’s cost, of such Collaboration Candidate. For each Collaboration Candidate, upon attaining clinical proof-of-concept, the Company shall have the right to elect to co-commercialize and share equally in the profits and losses in the United States, subject to the Company sharing in certain development costs. Under the terms of the Janssen Agreement, the Company is entitled to receive full funding for all research, preclinical development and IND-enabling activities performed by the Company for Collaboration Candidates, and is eligible to receive (i) with respect to the first Janssen Cancer Target, payments of up to $ 898.0 million upon the achievement of specified development, regulatory and sales milestones (the Janssen Milestone Payments) for the first Collaboration Candidate, and up to $ 460.0 million in Janssen Milestone Payments for each additional Collaboration Candidate, directed to the first Janssen Cancer Target; and (ii) with respect to each of the second, third and fourth Janssen Cancer Targets, up to $ 706.0 million in Janssen Milestone Payments for each of the first Collaboration Candidates, and up to $ 340.0 million in Janssen Milestone Payments for each additional Collaboration Candidate, directed to the applicable Janssen Cancer Target, where certain Janssen Milestone Payments under (i) and (ii) are subject to reduction in the event the Company elects to co-commercialize and share equally in the profits and losses in the United States of a respective Collaboration Candidate. The Company is further eligible to receive double-digit tiered royalties ranging up to the mid-teens on net sales of Collaboration Candidates that are commercialized by Janssen under the Janssen Agreement, subject to reduction under certain circumstances. Under the Stock Purchase Agreement, the Company sold 1.6 million shares of common stock to JJDC at $ 31.00 per share, for an aggregate purchase price of approximately $ 50.0 million, on April 7, 2020. The Company determined that this common stock purchase represented a premium of $ 9.93 per share, or $ 16.0 million in aggregate (the Equity Premium), and the remaining $ 34.0 million was recorded as an issuance of common stock in shareholders’ equity. In addition, under the Stock Purchase Agreement, the Company had the right to require JJDC to purchase an aggregate of $ 50.0 million in shares of the Company’s common stock in a private placement at the same price per share as that paid by investors in a public offering. In June 2020, in connection with the Company’s June 2020 public offering, the Company exercised this right and JJDC purchased in a private placement 1.8 million shares of the Company’s common stock at a price of $ 28.31 per share, for aggregate proceeds of $ 50.0 million. The Janssen Agreement permits Janssen to terminate development with respect to one or more Janssen Cancer Targets, or the entire Janssen Agreement, at any time on or after the second anniversary of the Janssen Agreement Effective Date, and the Company may terminate the Janssen Agreement with respect to a particular Janssen Cancer Target if a Collaboration Candidate has not been selected for IND-enabling studies for such Janssen Cancer Target within specified time periods under certain conditions. The Janssen Agreement contains customary provisions for termination by either party in the event of a material breach of the Janssen Agreement, subject to cure, by the other party and in the event of any bankruptcy, insolvency or similar events with respect to the other party. The Company applied ASC Topic 808, Collaborative Arrangements (ASC 808) and determined the Janssen Agreement is applicable to such guidance. The Company concluded that certain units of account within the Janssen Agreement represented a customer relationship and applied relevant guidance from ASC Topic 606, Revenue from Contracts with Customers (ASC 606) to evaluate the appropriate accounting for the Janssen Agreement. In accordance with this guidance, the Company identified its potential performance obligations, including its grant of a license to Janssen to certain of its intellectual property subject to certain conditions, its conduct of research and development services, and its participation in various joint oversight committees. The Company determined that its grant of a license to Janssen to certain of its intellectual property in the initial development stage was not distinct from other performance obligations because such grant is dependent on the conduct and results of the research and development services. Accordingly, the Company determined that its grant of a license to Janssen and its conduct of research and development services should be accounted for as one combined performance obligation, and that the combined performance obligation is transferred over the expected term of the conduct of the research and development services, which is estimated to be four years. Additionally, the Company determined that participation in the various joint oversight committees did not constitute a performance obligation as the Company’s participation in the various joint oversight committees does not transfer a service. The Company also assessed the effects of any variable elements under the Janssen Agreement. Such assessment evaluated, among other things, the funding to be received by the Company for its conduct of research and development services. Based on its assessment, the Company concluded that the total amount to be received by the Company for its conduct of research and development services is variable and cannot be readily estimated and, therefore, no amounts associated with such services were included in the initial transaction price. In addition, the Company also assessed its likelihood of receiving (i) preclinical milestones, (ii) various clinical, regulatory and commercial milestone payments, and (iii) royalties on net sales of the Collaboration Candidates. Based on the likelihood of receiving such milestone payments and royalties, no amounts associated with milestones or royalties were included in the initial transaction price. In accordance with ASC 606, the Company determined that the initial transaction price under the Janssen Agreement equals $ 66.0 million, consisting of the upfront, non-refundable and non-creditable payment of $ 50.0 million and the Equity Premium of $ 16.0 million. The Company concluded that there was not a significant financing component under the Janssen Agreement. The upfront payment of $ 66.0 million was recorded as deferred revenue and is being recognized as revenue consistent with the Company’s efforts related to the conduct of research and development services, as the research and development services are the primary component of the combined performance obligation. Since the total amount to be received by the Company for its research and development services under the Janssen Agreement could not be readily estimated, revenue associated with the upfront payment will be recognized based on actual headcount utilized as a percentage of total headcount expected to be utilized over the expected term of the conduct of the research and development services. Revenue associated with the research and development services will be recognized in an amount equal to the actual costs incurred during the period in which the research and development services are performed by the Company. During the year ended December 31, 2022, the Company achieved two research milestones under the Janssen Agreement and received a cash payment of $ 3.0 million each, for a total of $ 6.0 million received. In accordance with ASC 606, the Company determined that the milestone receivables represented an increase in the initial transaction price under the Janssen Agreement in the form of the receipt of variable consideration that was previously constrained. The Company recognized revenue associated with the milestone receivables in an amount equal to the proportional percentage of actual headcount incurred under the Janssen Agreement since its inception as a percentage of the total headcount expected to be utilized over the expected term of conduct of research and development services under the Janssen Agreement. The remaining unrecognized revenue associated with the milestones was recorded to deferred revenue, and is being recognized as revenue over the expected term of conduct of research and development services. On May 26, 2022, Janssen exercised a commercial option for a development candidate with respect to a particular Janssen Antigen (as defined under the Janssen Agreement). As a result, the Company received an Option Exercise Payment (as defined under the Janssen Agreement) of $ 10.0 million under the Janssen Agreement. The Company determined the exercise represented an option with no material right under the Janssen Agreement. The Company has not completed its performance obligations with respect to the exercise of the commercial option and accordingly, the Company has not recognized any revenue associated with the option exercise for the year ended December 31, 2022. The cash received for the Option Exercise Payment was recorded to deferred revenue, and will be recognized as revenue upon completion of the performance obligations. On September 14, 2022, Janssen provided notice of their intent to exercise a second commercial option for a development candidate with respect to a particular Janssen Antigen (as defined under the Janssen Agreement). This option exercise is subject to Competition Law Filings, and therefore the exercise effective date was deemed to be the Clearance Date, which occurred during the year ended December 31, 2022. Janssen owes the Company an Option Exercise Payment (as defined under the Janssen Agreement) of $ 10.0 million under the Janssen Agreement. The Company determined the exercise represented an option with no material right under the Janssen Agreement. The Company has completed its performance obligations with respect to the exercise of the commercial option and accordingly, recognized the Option Exercise Payment as revenue for the year ended December 31, 2022. On November 18, 2022, the Company filed an IND for the second antigen, development candidate, which was cleared by the FDA during the year ended December 31, 2022. Accordingly, the Company achieved a $ 3.0 million pre-defined clinical development milestone under the Janssen Agreement which was recognized as revenue during the year ended December 31, 2022. As a direct result of the Company’s entry into the Janssen Agreement, the Company incurred $ 17.1 million in sublicense fees to certain of its existing licensors. The $ 17.1 million in sublicense consideration represents an asset under ASC 340, Other Assets and Deferred Costs (ASC 340) and is amortized to research and development expense ratably with the Company’s revenue recognition under the Janssen Agreement. During the years ended December 31, 2022 and 2021, the Company recognized $ 4.3 million and $ 1.7 million of such expense, respectively. As of December 31, 2022 , the Janssen Agreement contract asset balance was $ 7.2 million. The Company recognized revenue of $ 79.7 million under the Janssen Agreement for the year ended December 31, 2022. Such revenue comprised $ 42.3 million associated with research and development services, $ 23.1 m illion associated with the upfront fee and Equity Premium, $ 13.0 million associated with a commercial option exercise and milestone achievements, and $ 1.3 million associated with collaboration services for the year ended December 31, 2022 . The Company recognized revenue of $ 43.7 million under the Janssen Agreement for the year ended December 31, 2021 . Such revenue comprised $ 29.5 million associated with research and development services and $ 14.2 million associated with the upfront fee and Equity Premium for the year ended December 31, 2021. As of December 31, 2022, aggregate deferred revenue related to the Janssen Agreement was $ 41.2 million, all of which is classified as current. As of December 31, 2022, the Company has recei ved $ 70.4 million in cash in aggregate research and development fees from Janssen. On January 3, 2023, the Company received notice of termination from Janssen of the Janssen Agreement. The termination will take effect on April 3, 2023 and, during the first quarter of 2023, the Company will wind down activities with Janssen, including discontinuing development of all collaboration products. Under the terms of the Janssen Agreement, in connection with the termination, (i) all licenses and other rights granted to either party pursuant to the Janssen Agreement will terminate, subject to limited exceptions set forth in the Janssen Agreement; (ii) both parties will wind down any development, commercialization and manufacturing activities under the Janssen Agreement; (iii) neither party will have any right to continue to develop, manufacture or commercialize any collaboration candidate or collaboration product or use the other party’s materials; and (iv) neither party is restricted from independently developing, manufacturing, or commercializing any product, including any products directed to the same antigens as those of any collaboration candidate or collaboration product. Ono Collaboration and Option Agreement Under a collaboration and option agreement with Ono Pharmaceutical Co. Ltd. (Ono) entered into in September 2018 and amended in June 2022 (the Ono Agreement), the Company is conducting research and preclinical development of off-the-shelf, iPSC-derived, CAR-targeted effector cells for the treatment of solid tumors. The Ono Agreement was initially designed to research and preclinically develop two iPSC-derived CAR T-cell product candidates, one of which was designated to target an antigen expressed on certain lymphoblastic leukemias (Candidate 1) and the second of which was designated to target an antigen expressed on certain solid tumors (Candidate 2) (each a Candidate and, collectively, the Candidates). The Company granted to Ono, during a specified period of time, a preclinical option to obtain an exclusive license under certain intellectual property rights to develop and commercialize: (a) Candidate 1 in Asia, where the Company retained rights for development and commercialization in all other territories of the world; and (b) Candidate 2 in all territories of the world, where the Company retained rights to co-develop and co-commercialize Candidate 2 in the United States and Europe under a joint arrangement with Ono under which the Company is eligible to share at least 50 % of the profits and losses. The Company maintained worldwide rights of manufacture for each Candidate. For each Candidate, the preclinical option expired upon the earliest of: (a) the achievement of the pre-defined preclinical milestone under the joint development plan; (b) termination by Ono of research and development activities for the Candidate; and (c) the date that is the later of (i) four years after the effective date, and (ii) completion of all applicable activities contemplated under the joint development plan. Ono paid the Company an upfront, non-refundable and non-creditable payment of $ 10.0 million in connection with entering into the Ono Agreement. Additionally, as consideration for the conduct of research and preclinical development under a joint development plan, Ono agreed to pay the Company annual research and development fees set forth in the annual budget included in the joint development plan, which fees were estimated to be $ 20.0 million in aggregate over the course of the joint development plan. In December 2020, the Company entered into a letter agreement with Ono pursuant to which Ono delivered proprietary antigen binding domains targeting an antigen expressed on certain solid tumors for incorporation into Candidate 2 and paid the Company a milestone fee of $ 10.0 million for further research and development of Candidate 2. In addition, Ono terminated all further research and development with respect to Candidate 1, and the Company retained all rights to research, develop and commercialize Candidate 1 throughout the world without any obligation to Ono. In June 2022, the Company entered into an amendment with Ono to the Ono Agreement (the Ono Amendment). Pursuant to the Ono Amendment, the companies agreed to designate an additional antigen expressed on certain solid tumors for research and preclinical development, and Ono agreed to contribute proprietary antigen binding domains targeting such additional solid tumor antigen (Candidate 3). In addition, for both Candidate 2 and Candidate 3, the companies expanded the scope of the collaboration to include the research and development of iPSC-derived CAR NK cell product candidates (in addition to iPSC-derived CAR T-cell product candidates) targeting the designated solid tumor antigens. Similar to Candidate 2, the Company granted to Ono, during a specified period of time, a preclinical option to obtain an exclusive license under certain intellectual property rights, subject to payment of an option exercise fee to the Company by Ono, to develop and commercialize Candidate 3 in all territories of the world, where the Company retains rights to co-develop and co-commercialize Candidate 3 in the United States and Europe under a joint arrangement with Ono under which the Company is eligible to share at least 50 % of the profits and losses. The Company maintained worldwide rights of manufacture for Candidate 3. The preclinical option expires upon the earlier of: (a) September 30, 2024, or (b) the achievement of the pre-defined preclinical milestone under the joint development plan for Candidate 3. Subject to payment of an extension fee by Ono, Ono may choose to defer its decision to exercise the preclinical option until no later than June 2026 . Under the Ono Amendment, aggregate estimated research and development fees have been increased by approximately $ 9.3 million, for a total estimated $ 29.3 million in aggregate research and development fees over the course of the joint development plan. Under the terms of the Ono Agreement, for Candidate 2 and for Candidate 3 (subject to exercise by Ono of its preclinical option to Candidate 3), we are eligible to receive additional payments upon the achievement of certain clinical, regulatory and commercial milestones (the Ono Milestones) with respect to each Candidate in an amount up to $ 843.0 million in aggregate, with the applicable milestone payments for the United States and Europe subject to reduction by 50 % if we elect to co-develop and co-commercialize the Candidate in the United States and Europe as described above. In addition, in those territories where Ono has exclusive rights of commercialization, we are eligible to receive tiered royalties (Royalties) ranging from the mid-single digits to the low-double digits based on annual net sales by Ono for each Candidate in such territories, with such royalties subject to certain reductions. The Ono Agreement will terminate with respect to a Candidate if Ono does not exercise its option for a Candidate within the option period, or in its entirety if Ono does not exercise any of its options for the Candidates within their respective option periods. In addition, either party may terminate the Ono Agreement in the event of breach, insolvency or patent challenges by the other party; provided, that Ono may terminate the Ono Agreement in its sole discretion (x) on a Candidate-by-Candidate basis at any time after the second anniversary of the effective date of the Ono Agreement or (y) on a Candidate-by-Candidate or country-by-country basis at any time after the expiration of the option period, subject to certain limitations. The Ono Agreement will expire on a Candidate-by-Candidate and country-by-country basis upon the expiration of the applicable royalty term, or in its entirety upon the expiration of all applicable payment obligations under the agreement. The Company determined that the Ono Agreement, Ono Letter Agreement, and Ono Amendment were within the scope of ASC 808. The Company concluded that certain units of account within the Ono Agreement and Ono Amendment represented a customer and applied relevant guidance from ASC 606 to evaluate the appropriate accounting for the those units of account. In accordance with this guidance, the Company identified its performance obligations, including its grant of a license to Ono to certain of its intellectual property subject to certain conditions, its conduct of research services, and its participation in a joint steering committee. The Company determined that its grant of a license to Ono to certain of its intellectual property subject to certain conditions was not distinct from other performance obligations because such grant is dependent on the conduct and results of the research services. Additionally, the Company determined that its conduct of research services was not distinct from other performance obligations since such conduct is dependent on the guidance of the joint steering committee. Accordingly, the Company determined that all performance obligations should be accounted for as one combined performance obligation, and that the combined performance obligation is transferred over the expected term of the conduct of the research services, which is estimated to be four years . The termination of the Ono Agreement with respect to Candidate 1 did not impact this assessment. The Company also assessed, in connection with the upfront, non-refundable and non-creditable payment of $ 10.0 million received in September 2018 and the $ 5.0 million prepayment of the first-year research and development fees in October 2018, and concluded that there was not a significant financing component to the Ono Agreement. The Company also assessed the effects of any variable elements under the Ono Agreement and Ono Amendment. Such assessment evaluated, among other things, the likelihood of receiving (i) preclinical milestone and option fees, (ii) various clinical, regulatory and commercial milestone payments, and (iii) royalties on net sales of either product Candidate. Based on its assessment, the Company concluded that, based on the likelihood of these variable components occurring, there was not a significant variable element included in the transaction price. Accordingly, the Company has not assigned a transaction price to any Ono Option Milestone, Ono Milestones or Ono Option Exercise Fees, other than the $10.0 million milestone triggered as part of the Ono Letter Agreement in December 2020, given the substantial uncertainty related to their achievement and has not assigned a transaction price to any Ono Royalties. In accordance with ASC 606, the Company determined that the initial transaction price under the Ono Agreement equals $ 39.3 million, consisting of the upfront, non-refundable and non-creditable payment of $ 10.0 million and the aggregate estimated research and development fees of $ 29.3 million. The upfront payment of $ 10.0 million was recorded as deferred revenue and is being recognized as revenue over time in conjunction with the Company’s conduct of research services as the research services are the primary component of the combined performance obligations. Revenue associated with the upfront payment will be recognized based on actual costs incurred as a percentage of the estimated total costs expected to be incurred over the expected term of conduct of the research services. The Company recorded the $ 5.0 million prepayment of the first-year research and development fees as deferred revenue, and such fees were recognized as revenue as the research services were delivered. In accordance with ASC 606, the Company concluded that the $ 10.0 million milestone payment associated with the Ono Letter Agreement represented an increase in the initial transaction price under the Ono Agreement in the form of the receipt of variable consideration that was previously constrained. The Company recognized revenue associated with the $ 10.0 million milestone payment in an amount equal to the proportional percentage of actual costs incurred under the Ono Agreement as a percentage of the estimated total costs expected to be incurred over the expected term of conduct of the research services. On November 7, 2022, Ono exercised its option for continued development of Collaboration Candidate 2 (as defined under the Ono Agreement). Upon exercise, the Company granted Ono a license to develop and commercialize Collaboration Candidate 2. The Company elected its CDCC Option for Collaboration Candidate 2. As a result, the Company is owed an Option Exercise Payment (as defined under the Ono Agreement) of $ 12.5 million. The Company determined the exercise represented an option with no material right under the Ono Agreement. The Company has completed its performance obligations with respect to the exercise of the option and accordingly, recognized the Option Exercise Payment as revenue for the year ended December 31, 2022. The Company and Ono will establish a joint development plan for the ongoing development of Collaboration Candidate 2. The costs of this development plan are accounted for in accordance with ASC 808, and cost sharing payments to the Company from Ono are recorded net into research and development expenses. As of December 31, 2022, there were no cost-sharing payments made to the Company from Ono. As a direct result of the Company’s entry into the Ono Agreement and the Ono Letter Agreement, the Company incurred an aggregate of $ 7.8 million in sublicense consideration to existing licensors of the Company. The $ 7.8 million in sublicense consideration represents an asset under ASC 340 and is being amortized to research and development expense ratably with the Company’s revenue recognition under the Ono Agreement. During the years ended December 31, 2022 and 2021, the Company recognized $ 4.1 million and $ 1.2 million, respectively, of such expense. As of December 31, 2022, there is no remaining contract asset balance for the Ono Agreement. The Company recognized revenue of $ 16.6 million, $ 12.1 million, and $ 14.6 million under the Ono Agreement and Ono Letter Agreement during the years ended December 31, 2022, 2021 and 2020, respectively. Such revenue comprised $ 2.5 million associated with research services, $ 1.6 million associated with the upfront payment, and $ 12.5 million associated with the option exercise during the year ended December 31, 2022. Suc h revenue comprised $ 6.0 million associated with the Ono Letter Agreement milestone earned in December 2021, $ 6.0 million associated with research services and $ 6.1 million associated with the upfront payment during the year ended December 31, 2021 . Such revenue comprised $ 5.7 million associated with research services and $ 2.8 million associated with the upfront payment during the year ended December 31, 2020. As of December 31, 2022, aggregate deferred revenue related to the Ono Agreement and Ono Letter Agreement was $ 1.1 million, all of which is classified as current. As of December 31, 2022, the Company has received $ 21.9 million in cash of aggregate research and development fees from Ono. Memorial Sloan Kettering Cancer Center License Agreement On May 15, 2018, the Company entered into an Amended and Restated Exclusive License Agreement (the Amended MSK License) with Memorial Sloan Kettering Cancer Center (MSK). The Amended MSK License amends and restates the Exclusive License Agreement entered into between the Company and MSK on August 19, 2016 (the Original MSK License), pursuant to which the Company entered into an exclusive license agreement with MSK for rights relating to compositions and methods covering iPSC-derived cellular immunotherapy, including T-cells and NK-cells derived from iPSCs engineered with CARs. Pursuant to the Amended MSK License, MSK granted to the Company additional licenses to certain patents and patent applications relating to new CAR constructs and off-the-shelf CAR T cells, including the use of clustered regularly interspaced short palindromic repeat (CRISPR) and other innovative technologies for their production, in each case to research, develop, and commercialize licensed products in the field of all human therapeutic uses worldwide. The Company has the right to grant sublicenses to certain licensed rights in accordance with the terms of the Amended MSK License, in which case it is obligated to pay MSK a percentage of certain sublicense income received by the Company. The Company is obligated to pay to MSK an annual license maintenance fee during the term of the agreement, and milestone payments upon the achievement of specified clinical, regulatory and commercial milestones for licensed products as well as royalty payments on net sales of licensed products In the event a licensed product achieves a specified clinical milestone, MSK is then eligible to receive certain milestone payments totaling up to $ 75.0 million based on the price of the Company’s common stock, where the amount of such payments owed to MSK is contingent upon certain increases in the price of the Company’s common stock following the date of achievement of such clinical milestone. These payments are based on common stock price multiples, with the numerator being the fair value of the ten-trading day trailing average closing price of the Company’s common stock and the denominator being the ten-trading day trailing average closing price of the Company’s common stock as of the effective date of the Amended MSK License, adjusted for any stock splits, cash dividends, stock dividends, other distributions, combinations, recapitalizations, or similar events. Under the terms of the Amended MSK License, upon a change of control of the Company, in certain circumstances, the Company may be required to pay a portion of these payments to MSK based on the price of the Company’s common stock in connection with such change of control. The following table summarizes the common stock multiples and the stock price appreciation milestone payments under the terms of the agreement : Common stock multiple 5.0x 10.0x 15.0x Ten-trading day trailing average common stock price $ 50.18 $ 100.36 $ 150.54 Stock price appreciation milestone payment (in millions) $ 20.0 $ 30.0 $ 25.0 In July 2021, the Company achieved the specified clinical milestone for a licensed product under the Amended MSK License and the Company’s ten-trading day trailing average common stock price exceeded the first, pre-specified threshold. As a result, the Company remitted the first milestone payment of $ 20.0 million to MSK during the year ended December 31, 2021. To determine the estimated fair value of the remaining stock price appreciation milestones, the Company uses a Monte Carlo simulation methodology which models future Company com |
California Institute for Regene
California Institute for Regenerative Medicine Award | 12 Months Ended |
Dec. 31, 2022 | |
Award From California Institute For Regenerative Medicine [Abstract] | |
California Institute for Regenerative Medicine Award | 3. California Institute for Regenerative Medicine Award On April 5, 2018 , the Company executed an award agreement with the California Institute for Regenerative Medicine (CIRM) pursuant to which CIRM awarded the Company $ 4.0 million to advance the Company’s FT516 product candidate into a first-in-human clinical trial for the treatment of subjects with advanced solid tumors, including in combination with monoclonal antibody therapy (the Award). The Award is subject to certain co-funding requirements by the Company, and the Company is required to provide CIRM progress and financial update reports under the Award. Pursuant to the terms of the Award, the Company, in its sole discretion, has the option to treat the Award either as a loan or as a grant. In the event the Company elects to treat the Award as a loan, the Company will be obligated to repay i) 60 %, ii) 80 %, iii) 100 % or iv) 100 % plus interest at 7 % plus LIBOR, of the total Award to CIRM, where such repayment rate is dependent upon the phase of clinical development of FT516 at the time of the Company’s election. If the Company does not elect to treat the Award as a loan within 10 years of the date of the Award, the Award will be considered a grant and the Company will be obligated to pay to CIRM a royalty on commercial sales of FT516 until such royalty payments equal nine times the total amount awarded to the Company under the Award. Since the Company may, at its election, repay some or all of the Award, the Company accounts for the Award as a liability until the time of election. As of December 31, 2022 , the Company has received all disbursements available under the Award in the amount of $ 4.0 million. The aggregate amount received is recorded as a CIRM Liability on the accompanying consolidated balance sheets and classified as current based on the potential amount payable within twelve months of the current balance sheet date. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2022 | |
Investments [Abstract] | |
Investments | 4. Investments The Company invests portions of excess cash in United States treasuries, commercial paper, non-U.S. government securities, municipal securities, and corporate debt securities with maturities ranging from three to thirty-six months from the purchase date. These investments are accounted for as available-for-sale securities and are classified as short-term and long-term investments in the accompanying consolidated balance sheets based on each security’s contractual maturity date. The following table summarizes the Company’s investments accounted for as available-for-sale securities as of December 31, 2022 and 2021 (in thousands): Maturity Amortized Unrealized Unrealized Estimated December 31, 2022 Classified as current assets: U.S. Treasury debt securities 1 or less $ 79,251 $ ( 263 ) $ 37 $ 79,025 Non-US government securities 1 or less 2,425 ( 2 ) — 2,423 Municipal securities 1 or less 18,963 ( 208 ) — 18,755 Corporate debt securities 1 or less 123,996 ( 1,138 ) 3 122,861 Commercial paper 1 or less 152,056 ( 230 ) 4 151,830 Total short-term investments $ 376,691 $ ( 1,841 ) $ 44 $ 374,894 Classified as non-current assets: Municipal securities Greater than 1 $ 5,000 $ ( 58 ) $ — $ 4,942 Total long-term investments $ 5,000 $ ( 58 ) $ — $ 4,942 December 31, 2021 Classified as current assets: U.S. Treasury debt securities 1 or less $ 70,653 $ ( 163 ) $ — $ 70,490 Municipal securities 1 or less 18,017 ( 6 ) 1 18,012 Corporate debt securities 1 or less 169,736 ( 187 ) — 169,549 Commercial paper 1 or less 224,333 ( 59 ) 2 224,276 Total short-term investments $ 482,739 $ ( 415 ) $ 3 $ 482,327 Classified as non-current assets: U.S. Treasury debt securities Greater than 1 $ 9,989 $ ( 35 ) $ — $ 9,954 Municipal securities Greater than 1 9,034 ( 42 ) — 8,992 Corporate debt securities Greater than 1 81,989 ( 271 ) — 81,718 Total long-term investments $ 101,012 $ ( 348 ) $ — $ 100,664 As of December 31, 2022 and 2021, the Company had $ 0.8 million and $ 1.1 million, respectively, of accrued interest on investments recorded in prepaid expenses and other assets on the consolidated balance sheets. The following tables present gross unrealized losses and fair values for those investments that were in an unrealized loss position as of December 31, 2022 and December 31, 2021 , aggregated by investment category and the length of time that individual securities have been in a continuous loss position (in thousands): Less Than 12 Months 12 Months or Greater Total Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses December 31, 2022 U.S. Treasury debt securities $ 51,246 $ ( 163 ) $ 9,898 $ ( 100 ) $ 61,144 $ ( 263 ) Non-US government securities 2,424 ( 2 ) — — 2,424 ( 2 ) Municipal securities 14,765 ( 193 ) 8,933 ( 73 ) 23,698 ( 266 ) Corporate debt securities 45,621 ( 174 ) 71,625 ( 964 ) 117,246 ( 1,138 ) Commercial paper 66,455 ( 230 ) — — 66,455 ( 230 ) Total $ 180,511 $ ( 762 ) $ 90,456 $ ( 1,137 ) $ 270,967 $ ( 1,899 ) December 31, 2021 U.S. Treasury debt securities $ 80,444 $ ( 198 ) $ — $ — $ 80,444 $ ( 198 ) Municipal securities 23,352 ( 48 ) — — 23,352 ( 48 ) Corporate debt securities 250,467 ( 458 ) — — 250,467 ( 458 ) Commercial paper 59,863 ( 59 ) — — 59,863 ( 59 ) Total $ 414,126 $ ( 763 ) $ — $ — $ 414,126 $ ( 763 ) The Company reviews its investment holdings at the end of each reporting period and evaluates any unrealized losses using the expected credit loss model to determine if the unrealized loss is a result of a credit loss or other factors. The Company also evaluates its investment holdings for impairment using a variety of factors including the Company’s intent to sell the underlying securities prior to maturity and whether it is more likely than not that the Company would be required to sell the securities before the recovery of their amortized basis. During the years ended December 31, 2022, 2021 and 2020 , the Company did no t recognize any impairment or realized gains or losses on sales of investments, and the Company did not record an allowance for, or recognize, any expected credit losses. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The following tables presents the Company’s financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2022 and 2021 (in thousands): Fair Value Measurements at Total Quoted Prices Significant Significant As of December 31, 2022: Financial assets: Money market funds $ 61,333 $ 61,333 $ — $ — U.S. Treasury debt securities 79,025 79,025 — — Non-US government securities 2,423 — 2,423 — Municipal securities 23,697 — 23,697 — Corporate debt securities 122,861 — 122,861 — Commercial paper 151,830 — 151,830 — Total assets measured at fair value on a recurring basis $ 441,169 $ 140,358 $ 300,811 $ — Financial liabilities: Stock price appreciation milestones $ 3,861 $ — $ — $ 3,861 Total financial liabilities measured at fair value on a recurring basis $ 3,861 $ — $ — $ 3,861 As of December 31, 2021: Financial assets: Money market funds $ 133,583 $ 133,583 $ — $ — U.S. Treasury debt securities 80,444 80,444 — — Municipal securities 27,004 — 27,004 — Corporate debt securities 251,267 — 251,267 — Commercial paper 224,276 — 224,276 — Total assets measured at fair value on a recurring basis $ 716,574 $ 214,027 $ 502,547 $ — Financial liabilities: Stock price appreciation milestones $ 24,168 $ — $ — $ 24,168 Total financial liabilities measured at fair value on a recurring basis $ 24,168 $ — $ — $ 24,168 Level 1 assets consisted of money market funds and U.S. Treasury securities measured at fair value based on quoted prices in active markets as provided by the Company’s investment managers. Level 2 assets consisted of corporate debt securities, commercial paper, municipal securities, and non-U.S. government securities measured at fair value using standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers. The Company validates the quoted market prices provided by its investment managers by comparing the investment managers’ assessment of the fair values of the Company's investment portfolio balance against the fair values of the Company's investment portfolio balance obtained from an independent source. There were no Level 3 assets held by the Company as of December 31, 2022. Level 3 liabilities consisted of stock price appreciation milestones associated with the Amended MSK License as described in detail in Note 2. To determine the estimated fair value of the stock price appreciation milestones, the Company uses a Monte Carlo simulation methodology which models future Company common stock prices based on several key variables. The assumptions used to calculate the fair value of the stock price appreciation milestones are subject to a significant amount of judgment including the expected volatility of the Company’s common stock and estimated term, which is based in part on the last valid patent claim date. Fair value measurements are highly sensitive to changes in these inputs and significant changes could result in a significantly higher or lower fair value and resulting expense or gain. Further, as the stock price appreciation milestones are first contingent upon the achievement of a specified clinical milestone, the Company also estimates the fair value of the stock price appreciation milestones based on the probability of achieving the clinical milestone. This assessment is based on several factors including the successful achievement of technological, manufacturing, and regulatory requirements. A small change in the assumptions and other inputs, such as the price of the Company’s common stock, may have a relatively large change in the estimated fair value of the stock price appreciation milestones and associated liability and expense. For example, keeping all other variables constant, a hypothetical 10 % increase in the stock price at December 31, 2022 from $ 10.09 to $ 11.10 per share would have decreased the income recorded during 2022 by $ 0.4 million related to the stock price appreciation milestones. Keeping all other variables constant, a hypothetical 10 % decrease in the stock price at December 31, 2022 from $ 10.09 to $ 9.08 per share would have increased the income recorded during 2022 by $ 0.4 million related to the stock price appreciation milestones. The following table presents the changes in fair value of the Company’s Level 3 stock price appreciation milestones liability (in thousands): Balance at December 31, 2021 $ 24,168 Changes in fair value of stock price appreciation milestones liability ( 20,307 ) Balance at December 31, 2022 $ 3,861 None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 6. Property and Equipment Property and equipment consist of the following (in thousands): December 31, 2022 2021 Furniture and fixtures $ 1,209 $ 1,209 Computer and office equipment 2,937 2,168 Software 2,122 1,899 Leasehold improvements—building 56,782 52,948 Scientific equipment 77,354 50,250 Total property and equipment, gross 140,404 108,474 Less accumulated depreciation and amortization ( 30,384 ) ( 16,945 ) Total property and equipment, net $ 110,020 $ 91,529 Depreciation expense related to property and equipment was $ 13.8 million, $ 5.9 million, and $ 3.1 million, for the years ended December 31, 2022, 2021, and 2020, respectively. No material gains or losses on the disposal of property and equipment have been recorded for the years ended December 31, 2022, 2021, and 2020 . |
Accrued Expenses and Long-Term
Accrued Expenses and Long-Term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses And Long Term Debt Disclosure [Abstract] | |
Accrued Expenses and Long-Term Debt | 7. Accrued Expenses Accrued Expenses Current accrued expenses consist of the following (in thousands): December 31, 2022 2021 Accrued payroll and other employee benefits $ 17,899 $ 18,358 Accrued clinical trial related costs 16,858 12,344 Accrued other 19,175 11,710 Total current accrued expenses $ 53,932 $ 42,412 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | 8. Leases The Company has lease agreements for office, laboratory and manufacturing spaces that are classified as operating leases on the consolidated balance sheets. These leases have terms varying from one to approximately sixteen years , with renewal options of up to ten years , as well as early termination options. Extension and termination options are included in the total lease term when the Company is reasonably certain to exercise them. The leases are subject to additional variable charges, including common area maintenance, property taxes, property insurance and other variable costs. Given the variable nature of such costs, they are recognized as expense as incurred. Additionally, some of the Company’s leases are subject to certain fixed fees which the Company has determined to be non-lease components. The Company has elected to combine and account for lease and non-lease components as a single lease component for purposes of determining the total future lease payments. In January 2020, the Company entered into a lease agreement for certain office, laboratory and manufacturing space (the Premises), and such lease is accounted for as an operating lease. The Premises are located in San Diego, California and the Company moved its corporate headquarters to the Premises in August 2021. Lease payments commenced in May 2021 (the Rent Commencement Date) and the lease has a lease term of 15 years starting from the Rent Commencement Date. The Company has the option to extend the lease for two successive five-year periods. The Company also has a one-time option to terminate the lease after 10 years from the Rent Commencement Date , subject to payment of a $ 30.0 million early termination fee. The landlord of the Premises is obligated to contribute an aggregate of up to $ 29.8 million toward tenant improvements of the Premises. As of December 31, 2022 , the Company had utilized the entire tenant improvements allowance. The Company recorded the tenant improvement allowance as part of the Company's leasehold improvements, which is depreciated in accordance with the Company's Property and Equipment policy. In connection with the lease, the Company maintains a letter of credit for the benefit of the landlord in an amount equal to $ 15.0 million, which amount is subject to reduction over time. In November 2021, the Company entered into a lease agreement for certain office space in San Diego, California, and such lease is accounted for as an operating lease. Lease payments commenced, subject to certain conditions, in January 2022 (the Rent Commencement Date) and the lease has a lease term of 6 years starting from the Rent Commencement Date. The Company has no option to extend the lease, and no option to early terminate the lease. Upon lease commencement in December 2021, the Company recorded a right-of-use asset of $ 6.0 million. As of December 31, 2022, future undiscounted minimum contractual payments under the Company’s operating leases were $ 177.7 million, which will be paid over a remaining weighted-average lease term of 11.5 years. The weighted-average discount rate for the operating lease liabilities was 8.28 %, which was the Company's incremental borrowing rate at lease commencement, as the discount rates implicit in the leases could not be readily determined. The components of lease expense for the years ended December 31, 2022, 2021, and 2020 were as follows (in thousands): Years Ended 2022 2021 2020 Straight-line lease expense $ 15,010 $ 15,354 $ 12,076 Variable lease expense 2,614 1,660 2,245 Total operating lease expense $ 17,624 $ 17,014 $ 14,321 No short-term lease expense was recognized in the years ended December 31, 2022 and 2021. Total short-term lease expense associated with short-term leases for the year ended December 31, 2020 was $ 1.2 million. Future undiscounted minimum payments under the Company’s operating leases as of December 31, 2022 are as follows (in thousands): Operating Years Ending December 31, 2023 $ 14,597 2024 14,836 2025 15,087 2026 15,540 2027 16,006 Thereafter 101,636 Total undiscounted lease payments $ 177,702 Less: imputed interest ( 68,364 ) Total lease liability $ 109,338 |
Convertible Preferred Stock and
Convertible Preferred Stock and Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Convertible Preferred Stock And Stockholders Deficit Disclosure [Abstract] | |
Convertible Preferred Stock and Stockholders’ Equity | 9. Convertible Preferred Stock and Stockholders’ Equity Convertible Preferred Stock In November 2016, the Company completed a private placement of stock in which investors, including investors affiliated with the directors and officers of the Company, purchased convertible preferred stock and common stock of the Company (the November 2016 Placement). The Company issued 2,819,549 shares of non-voting Class A Convertible Preferred Stock (the Class A Preferred) at $ 13.30 per share, each of which is convertible into five shares of common stock upon certain conditions defined in the Certificate of Designation of Preferences, Rights and Limitations of the Class A Preferred filed with the Delaware Secretary of State on November 22, 2016 (the CoD). The Class A Preferred were purchased exclusively by entities affiliated with Redmile Group, LLC (collectively, Redmile). The terms of the CoD prohibited Redmile from converting the Class A Preferred into shares of the Company’s common stock if, as a result of conversion, Redmile, together with its affiliates, would own more than 9.99 % of the Company’s common stock then issued and outstanding (the Redmile Percentage Limitation), which percentage could change at Redmile’s election upon 61 days’ notice to the Company to (i) any other number less than or equal to 19.99 % or (ii) subject to approval of the Company’s stockholders to the extent required in accordance with the NASDAQ Global Market rules, any number in excess of 19.99 %. On May 2, 2017, the Company’s stockholders approved the issuance of up to an aggregate of 14,097,745 shares of common stock upon the conversion of the outstanding shares of Class A Preferred. As a result, Redmile has the right to increase the Redmile Percentage Limitation to any percentage in excess of 19.99 % at its election. The Company also issued 7,236,837 shares of common stock at $ 2.66 per share as part of the November 2016 Placement. The Class A Preferred are non-voting shares and have a stated par value of $ 0.001 per share and are convertible into five shares of the Company’s common stock at a conversion price of $ 2.66 per share, which was the fair value of the Company’s common stock on the date of issuance. Holders of the Class A Preferred have the same dividend rights as holders of the Company’s common stock. Additionally, the liquidation preferences of the Class A Preferred are pari passu among holders of the Company’s common stock and holders of the Class A Preferred, pro rata based on the number of shares held by each such holder (treated for this purpose as if the Class A Preferred had been converted to common stock). During the year ended December 31, 2019, 25,000 shares of the Company’s Class A Preferred were converted into 125,000 shares of the Company’s common stock. Description of Securities Dividends As of December 31, 2022 , the Board of Directors of the Company has no t declared any dividends. Stock Option and Incentive Plans and Inducement Equity Plan 2013 Stock Option and Incentive Plan On August 28, 2013, the Company’s board of directors and stockholders approved and adopted the 2013 Stock Option and Incentive Plan (the 2013 Plan). The 2013 Plan became effective immediately prior to the Company’s IPO. The 2013 Plan was subsequently amended in May 2017. Under the 2013 Plan, the Company could grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, directors or consultants of the Company or its subsidiaries. Recipients of stock options under the 2013 Plan shall be eligible to purchase shares of the Company’s common stock at an exercise price equal to no less than the estimated fair value of such stock on the date of grant. Under the 2013 Plan, stock options generally vest 25 % on the first anniversary of the original vesting date, with the balance vesting monthly over the remaining three years , or vest monthly over four years , unless they contain specific performance and/or market-based vesting provisions. The maximum term of stock options granted under the 2013 Plan is ten years . Under the 2013 Plan, restricted stock units generally vest annually over four years . Performance-based stock units/awards vest upon the achievement of certain pre-defined company-specific performance-based clinical achievement criteria. The 2013 Plan was replaced by the 2022 Stock Option and Incentive Plan on June 9, 2022. 2022 Stock Option and Incentive Plan On June 9, 2022, the Company adopted the 2022 Stock Option and Incentive Plan (the “2022 Plan” ). The 2022 Plan authorizes 9.5 million shares of common stock for issuance and allows for the grant of stock options, stock appreciation rights, restricted stock awards, performance-based awards, and other awards to individuals who are then employees, officers, directors or consultants of the Company. The shares of common stock underlying any awards from the 2022 Plan and a previously existing equity plan from 2013 or 2007 that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by us prior to vesting, satisfied without any issuance of common stock, expire or are otherwise terminated (other than by exercise) are added back to the shares of common stock available for issuance under the 2022 Plan. Recipients of stock options under the 2022 Plan shall be eligible to purchase shares of the Company’s common stock at an exercise price equal to no less than the estimated fair value of such stock on the date of grant. Under the 2022 Plan, stock options generally vest 25 % on the first anniversary of the original vesting date, with the balance vesting monthly over the remaining three years , or vest monthly over four years , unless they contain specific performance and/or market-based vesting provisions. The maximum term of stock options granted under the 2022 Plan is ten years . Under the 2022 Plan, restricted stock units generally vest annually over four years . Performance-based stock units/awards vest upon the achievement of certain pre-defined company-specific performance-based clinical achievement criteria. Inducement Plan On May 10, 2016, the Company’s board of directors approved the Fate Therapeutics, Inc. Inducement Equity Plan (the Inducement Plan), the purpose of which is to enable the Company to grant equity awards to induce highly-qualified prospective officers and employees who are not employed by the Company to accept employment with the Company. Under the Inducement Plan, the Company may grant non-qualified stock options and restricted stock units. A total of 500,000 shares of common stock were initially reserved for issuance under the Inducement Plan. In January 2021, March 2020, and January 2019, an additional 300,000 shares, 470,822 shares, and 200,000 shares, respectively, of common stock were reserved for issuance under the Inducement Plan. The shares of common stock underlying any awards from the Inducement Plan that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by us prior to vesting, satisfied without any issuance of common stock, expire or are otherwise terminated (other than by exercise) under the Inducement Plan will be added back to the shares of common stock available for issuance under the Inducement Plan. Employee Stock Purchase Plan On September 13, 2013, the Company’s board of directors approved and adopted the 2013 Employee Stock Purchase Plan (the ESPP). A total of 729,000 shares of common stock were initially reserved for issuance under the ESPP. In addition, the number of shares of stock available for issuance under the ESPP will be automatically increased each January 1, beginning on January 1, 2015, by the lesser of (i) 2 % of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31, (ii) 450,000 shares, or (iii) such lesser number as determined by the compensation committee of the Company’s board of directors. No purchases have been made to date under the ESPP. Pre-Funded Warrants In January 2021, in conjunction with a public offering, the Company issued Pre-Funded Warrants, in lieu of common stock to certain investors, to purchase 257,310 shares of the Company’s common stock. The purchase price for the Pre-Funded Warrants was $ 85.499 per Pre-Funded Warrant, which equals the per share public offering price for the shares of common stock less the $ 0.001 exercise price for each such Pre-Funded Warrant. Given that the Pre-Funded Warrants are indexed to the Company’s own shares of common stock (and otherwise meet the requirements to be classified in equity), the Company recorded the consideration received from the issuance of the warrants as additional paid-in capital on the Company’s consolidated balance sheets. The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise the Pre-Funded 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 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 December 31, 2022 , there were 257,310 Pre-Funded Warrants outstanding. Stock Options and Restricted Stock Unit Awards Stock Options. The following table summarizes stock option activity and related information under all equity plans for the year ended December 31, 2022: Options Weighted Weighted Aggregate Outstanding at December 31, 2021 7,708,263 $ 20.43 Granted 848,457 36.68 Exercised ( 941,780 ) 9.74 Cancelled ( 347,714 ) 48.56 Outstanding at December 31, 2022 7,267,226 $ 22.37 6.30 $ 7,577 Options vested and expected to vest at December 31, 2022 7,267,226 $ 22.37 6.30 $ 7,577 Options exercisable at December 31, 2022 5,722,035 $ 18.20 5.79 $ 7,577 For the years ended December 31, 2022, 2021, and 2020, the weighted average grant date fair value of stock options granted per share was equal to $ 24.07 , $ 55.83 and $ 18.87 , respectively. As of December 31, 2022, 2021 and 2020, the unrecognized compensation cost related to outstanding options was $ 35.1 million, $ 48.9 million and $ 66.1 million, respectively, which was expected to be recognized as expense over approximately 2.2 years, 2.3 years and 2.9 years, respectively. The total intrinsic value, which is the amount by which the exercise price was exceeded by the price of the Company’s common stock on the date of exercise, of stock options exercised during the years ended December 31, 2022, 2021 and 2020, was $ 23.8 million, $ 184.3 million and $ 59.7 million, respectively. Total cash received upon the exercise of stock options was $ 9.2 million for the year ended December 31, 2022. Restricted Stock Units. The following table summarizes restricted stock unit activity and related information under all equity plans for the year ended December 31, 2022: Number of Weighted Weighted Aggregate Outstanding at December 31, 2021 4,008,832 $ 58.60 Granted 3,211,208 36.58 Vested ( 626,175 ) 53.44 Cancelled ( 731,132 ) 51.46 Outstanding at December 31, 2022 5,862,733 $ 48.13 3.13 $ 59,155 Restricted stock units expected to vest at December 31, 2022 4,065,114 $ 44.46 2.75 $ 41,017 As of December 31, 2022, 2021 and 2020, the unrecognized compensation cost related to outstanding restricted stock units (excluding those with unachieved performance-based conditions) was $ 137.7 million, $ 98.2 million and $ 20.8 million, respectively, which was expected to be recognized as expense over approximately 2.8 years, 3.2 years and 2.9 years, respectively. During the year ended December 31, 2021, 1,199,377 performance-based restricted stock units ("PRSUs") were granted, none of which have vested. No PRSUs were granted during the year ended December 31, 2022. There were 1,797,619 and 1,199,377 PRSUs outstanding at December 31, 2022 and 2021, respectively. Stock-Based Compensation Expense The allocation of stock-based compensation for all stock awards is as follows (in thousands): Years Ended 2022 2021 2020 Research and development $ 51,103 $ 35,140 $ 18,636 General and administrative 27,630 19,224 12,117 Total stock-based compensation expense $ 78,733 $ 54,364 $ 30,753 Stock Option Grants Valuation. T he weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee and nonemployee stock option grants were as follows: Years Ended 2022 2021 2020 Risk–free interest rate 1.9 % 0.5 % 1.0 % Expected volatility 76.2 % 76.5 % 77.5 % Expected term (in years) 5.8 5.1 5.5 Expected dividend yield 0.0 % 0.0 % 0.0 % Risk-free interest rate. The Company bases the risk-free interest rate assumption on observed interest rates appropriate for the expected term of the stock option grants. Expected dividend yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends. Expected volatility. During the years ended December 31, 2022 and 2021, the Company based the expected volatility on the historical volatility of its common stock over the most recent period commensurate with the estimated expected term of the Company’s stock options, as the Company determined there was sufficient operating history and company-specific historical volatility to estimate the expected volatility. Expected term. The expected term represents the period of time that options are expected to be outstanding. During the years ended December 31, 2022 and 2021, the Company estimated the expected term using historical experience and anticipated future exercise behavior. Common Stock Reserved for Future Issuance Common stock reserved for future issuance is as follows: December 31, 2022 2021 Convertible preferred stock (if converted) 13,972,745 13,972,745 Common stock options 7,267,226 7,708,263 Restricted stock units 5,862,733 4,008,832 Awards available under the 2013 Plan — 3,356,946 Awards available under the 2022 Plan 10,274,169 — Awards available under the Inducement Plan 741,000 856,000 Employee stock purchase plan 729,000 729,000 Total 38,846,873 30,631,786 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes The following is a reconciliation of the Company’s expected federal income tax provision (benefit) to the actual income tax provision (in thousands): Years Ended December 31, 2022 2021 2020 Tax computed at federal statutory rate $ ( 59,161 ) $ ( 44,551 ) $ ( 36,411 ) State tax, net of federal tax benefit ( 11,109 ) ( 6,966 ) ( 1,296 ) Non-deductible compensation 2,086 10,202 75 Permanent differences ( 1,340 ) ( 686 ) ( 240 ) Stock compensation 3,356 ( 35,852 ) ( 6,073 ) R&D tax credits ( 14,484 ) ( 12,140 ) ( 7,177 ) Reserve for uncertain tax positions 12,564 7,192 1,555 Other ( 1,376 ) 84 70 Valuation allowance 69,464 82,717 49,497 Income tax expense $ — $ — $ — Significant components of the Company’s deferred tax assets are summarized as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Capitalized R&D expense $ 127,250 $ 95,172 Net operating losses 84,608 62,913 R&D tax credits 49,736 35,387 Intangible asset amortization 8,012 6,985 Deferred revenue 8,714 8,706 Stock compensation 13,128 8,710 Lease liability 22,961 24,112 Other 2,526 6,972 Total deferred tax assets 316,935 248,957 Deferred tax liabilities: Depreciation ( 6,814 ) ( 7,323 ) Right-of-use assets ( 13,874 ) ( 14,851 ) Total deferred tax liabilities ( 20,688 ) ( 22,174 ) Net of deferred tax assets and liabilities 296,247 226,783 Valuation allowance ( 296,247 ) ( 226,783 ) Net deferred tax assets $ — $ — A valuation allowance of $ 296.2 million and $ 226.8 million at December 31, 2022 and 2021, respectively, has been established to offset the deferred tax assets, as realization of such assets is uncertain. At December 31, 2022, the Company had federal and California net operating loss (NOL) carryforwards of $ 392.5 million and $ 452.2 million, respectively, which may be available to offset future taxable income. The federal and California NOL carryforwards begin to expire in 2027 and 2028 , respectively, unless previously utilized. At December 31, 2022 , the Company had federal and California research and development (R&D) credit carryforwards of $ 35.1 million and $ 33.3 million, respectively. The federal R&D tax credit carryforwards will begin to expire in 2035 unless previously utilized. The California R&D credit carryforwards will carry forward indefinitely. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, (the Code), substantial changes in the Company's ownership may limit the amount of net operating loss and research and development credit carryforwards that could be used annually in the future to offset taxable income. The tax benefits related to future utilization of federal and state net operating loss carryforwards, credit carryforwards, and other deferred tax assets may be limited or lost if cumulative changes in ownership exceeds 50 % within any three-year period. The Company completed a study to assess whether an ownership change, as defined by Section 382 of the Code, had occurred from the Company’s formation through December 31, 2015. Based upon this study, the Company determined that several ownership changes had occurred. Accordingly, the Company reduced its deferred tax assets related to the federal NOL carryforwards and the federal R&D credit carryforwards that are anticipated to expire unused as a result of these ownership changes. These tax attributes were excluded from deferred tax assets with a corresponding reduction of the valuation allowance with no net effect on income tax expense or the effective tax rate. The Company updated the study through December 31, 2022 and concluded there were no ownership changes during 2022. Future ownership changes may further limit the Company’s ability to utilize its remaining tax attributes. The Company files income tax returns in the United States, various state jurisdictions, and the Netherlands with varying statutes of limitations. The Company currently has no years under examination by any jurisdiction; however, the Company is subject to income tax examination by federal and state tax authorities for years beginning in 2019 and 2018 , respectively. However, to the extent allowed by law, the taxing authorities may have the right to examine prior periods where NOLs and tax credits were generated and carried forward, and make adjustments up to the amount of the carryforwards. The change in the Company’s unrecognized tax benefits is summarized as follows (in thousands): December 31, 2022 2021 2020 Beginning unrecognized tax benefits $ 37,255 $ 19,779 $ 16,822 Increase related to current year tax positions 9,101 17,557 1,837 Increase related to prior year tax positions 6,411 — 1,120 Decrease related to prior year tax positions — ( 81 ) — Ending unrecognized tax benefits $ 52,767 $ 37,255 $ 19,779 The Company does no t anticipate that the amount of unrecognized tax benefits as of December 31, 2022 will significantly change within the next twelve months. Due to the valuation allowance recorded against the Company’s deferred tax assets, no ne of the total unrecognized tax benefits as of December 31, 2022 would reduce the effective tax rate if recognized. The Company has not recognized interest or penalties related to income tax matters in its consolidated statements of operations and comprehensive loss since inception. |
Employee Benefits
Employee Benefits | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Benefits | 11. Employee Benefits Effective January 1, 2009, the Company adopted a defined contribution 401(k) plan for employees who are at least 21 years of age. Employees are eligible to participate in the plan beginning on the first day of the calendar quarter following date of hire. Under the terms of the plan, employees may make voluntary contributions as a percent of compensation. The Company makes discretionary contributions to the 401(k) Plan equal to 100 percent of each employee’s pretax contributions up to 20 percent of the IRS Standard Limit. No matching contributions have been made by the Company as of December 31, 2022 since the adoption of the 401(k) plan. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies License Agreements The Company has entered into exclusive license agreements with certain academic institutions and universities pursuant to which the Company acquired certain intellectual property. Pursuant to each agreement, as consideration for an exclusive license to the intellectual property, the Company paid a license fee, reimbursed the institution for historical patent costs and, in certain instances, issued the institution shares of restricted common stock. Additionally, under each agreement, the institution is generally eligible to receive future consideration including, but not limited to, annual maintenance fees, royalties, milestone payments and sublicensing fees. Each of the license agreements is generally cancelable by the Company, given appropriate prior written notice. Minimum annual payments to maintain these cancelable licenses total an aggregate of $ 0.4 million. See Note 2 for additional information on certain licenses. Litigation From time to time, the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course of business. Management believes there are no claims or actions pending against the Company as of December 31, 2022 which will have, individually or in the aggregate, a material adverse effect on its business, liquidity, financial position, or results of operations. Litigation, however, is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm the Company’s business. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events Janssen Agreement Termination On January 3, 2023, the Company received notice of termination from Janssen of the Collaboration and Option Agreement dated April 2, 2020 by and between the Company and Janssen (the “Collaboration Agreement”), pursuant to which Janssen and the Company had agreed to collaborate to develop iPSC-derived CAR NK- and CAR T-cell product candidates for the treatment of cancer. Janssen provided notice of termination after the Company declined a proposal from Janssen for continuation of the Collaboration Agreement on revised terms. The termination will take effect on April 3, 2023 and, during the first quarter of 2023, the Company will wind down activities with Janssen, including discontinuing development of all collaboration products. Under the terms of the Collaboration Agreement, in connection with the termination, (i) all licenses and other rights granted to either party pursuant to the Collaboration Agreement will terminate, subject to limited exceptions set forth in the Collaboration Agreement; (ii) both parties will wind down any development, commercialization and manufacturing activities under the Collaboration Agreement; (iii) neither party will have any right to continue to develop, manufacture or commercialize any collaboration candidate or collaboration product or use the other party’s materials; and (iv) neither party is restricted from independently developing, manufacturing, or commercializing any product, including any products directed to the same antigens as those of any collaboration candidate or collaboration product. Corporate Restructuring In January 2023, the Company implemented a corporate restructuring to streamline operations, reduce operating expenses, extend cash runway and focus resources on the Company's most promising programs. In connection with the restructuring, the Company committed to a reduction in total workforce by approximately 60 %, to approximately 220 employees. Affected employees were informed on January 5, 2023. The Company expects the reduction in force to be completed during the first quarter of 2023, and that it will incur charges of approximately $ 12 million to $ 16 million for severance and other employee termination-related costs during the first quarter of 2023. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, its workforce reduction. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Public Equity Offering | Public Equity Offerings In January 2021, the Company completed a public offering of common stock in which investors, certain of which are affiliated with a director of the Company, purchased 5.1 million shares of the Company’s common stock at a price of $ 85.50 per share under a shelf registration statement. In addition, the Company issued pre-funded warrants, in lieu of common stock to certain investors, to purchase 257,310 shares of the Company’s common stock (Pre-Funded Warrants). The purchase price of the Pre-Funded Warrants was $ 85.499 per Pre-Funded Warrant, which equals the per share public offering price for the shares of common stock less the $ 0.001 exercise price for each such Pre-Funded Warrant. See Note 9 for additional detail. Gross proceeds from the public offering and the issuance of the Pre-Funded Warrants were $ 460.0 million, and after giving effect to $ 27.6 million of costs related to the public offering and the issuance of Pre-Funded Warrants, net proceeds were $ 432.4 million. In June 2020, the Company completed a public offering of common stock in which investors, certain of which are affiliated with a director of the Company, purchased 7.1 million shares of its common stock at a price of $ 28.31 per share under a shelf registration statement. Gross proceeds from the offering were $ 201.3 million, and after giving effect to $ 12.5 million of costs related to the offering, net proceeds were $ 188.8 million. |
Private Placements of Common Stock | Private Placements of Common Stock In June 2020, in connection with the June 2020 public offering of common stock, the Company exercised its right to cause an existing shareholder, Johnson & Johnson Innovation-JJDC, Inc (JJDC), to purchase $ 50.0 million of the Company’s common stock, and JJDC purchased in a private placement 1.8 million shares of the Company’s common stock at a price of $ 28.31 per share, for aggregate proceeds of $ 50.0 million. In April 2020, in connection with the Janssen Agreement described in Note 2, JJDC purchased in a private placement 1.6 million shares of the Company’s common stock at a price of $ 31.00 per share, for aggregate proceeds of $ 50.0 million. The shares of common stock purchased in the private placements were not subject to any underwriting discounts or commissions. |
Use of Estimates | Use of Estimates The Company’s consolidated financial statements are prepared in accordance with United States generally accepted accounting principles (U.S. GAAP). The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to its stock appreciation milestone obligations, contracts containing leases, and accrued expenses. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Risks and Uncertainties | Risks and Uncertainties Due to the global outbreak of SARS-CoV-2, the strain of coronavirus that causes Coronavirus disease 19 (COVID-19), including the emergence of new variants of the virus, the Company experienced impacts on certain aspects of its business, including its clinical trial and research and development activities, during the year ended December 31, 2022 . For example, the Company implemented in response to governmental “stay at home” orders and in the interests of public health and safety, and the Company has experienced delays or disruptions in the initiation and conduct of its clinical trials as a result of prioritization of hospital and other medical resources toward pandemic efforts, policies and procedures implemented at clinical sites with respect to the conduct of clinical trials, and other precautionary measures taken in treating patients or in practicing medicine in response to the COVID-19 pandemic. The scope and duration of these delays and disruptions, and the ultimate impacts of COVID-19 on the Company’s operations, are currently unknown. The Company is continuing to actively monitor the situation and may take further precautionary and preemptive actions as may be required by federal, state or local authorities or that it determines are in the best interests of public health and safety and that of the Company’s patient community, employees, partners, and stockholders. The Company cannot predict the effects that such actions, or the impact of COVID-19 on global business operations and economic conditions, may have on its business, strategy, collaborations, or financial and operating results. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its subsidiaries. To date, the aggregate operations of these subsidiaries have not been significant and all intercompany transactions and balances have been eliminated in consolidation. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating and reportable segment. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments consist primarily of cash and cash equivalents, marketable securities, accounts receivable, stock price appreciation milestones, accounts payable, and accrued liabilities. The carrying amounts of accounts receivable, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the relatively short-term nature of those instruments. The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three- tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash in readily available checking and savings accounts, money market accounts and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows as of December 31, 2022, 2021 and 2020 (in thousands): Years Ended December 31, 2022 2021 2020 Cash and cash equivalents $ 61,333 $ 133,583 $ 167,347 Restricted cash 15,227 15,227 15,227 Total cash, cash equivalents, and restricted cash shown in the consolidated statement of cash flows $ 76,560 $ 148,810 $ 182,574 For the years ended December 31, 2022, 2021 and 2020 , the restricted cash balance includes cash-collateralized irrevocable standby letters of credit for $ 15.2 million associated with the Company’s facilities leases . |
Investments | Investments Investments are accounted for as available-for-sale securities and are carried at fair value on the consolidated balance sheets. Upon initial recognition of the investment and at each reporting period, the Company evaluates whether any unrealized losses on investments are attributable to a credit loss or other factors. Any unrealized losses attributable to credit loss are recorded through an allowance for credit losses, limited to the amount by which the fair value is below amortized cost, with the offsetting amount recorded in other income or expense in the consolidated statement of operations and comprehensive loss. Unrealized losses not attributable to an expected credit loss and unrealized gains on investments are recorded in other comprehensive income (loss) on the consolidated statements of operations and comprehensive loss. Realized gains and losses, if any, on investments classified as available-for-sale securities are included in other income or expense. The amortized cost of investments classified as available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments, which potentially subject the Company to a significant concentration of credit risk, consist primarily of cash and cash equivalents and investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits and investments are held. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally two to five years ) and generally consist of furniture and fixtures, computers, scientific and office equipment, and in-process costs related to facilities construction. Repairs and maintenance costs are charged to expense as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. If the carrying amount is not recoverable, the Company measures the amount of any impairment by comparing the carrying value of the asset to the present value of the expected future cash flows associated with the use of the asset. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, management believes that future cash flows to be received support the carrying value of its long-lived assets and, accordingly, has not recognized any impairment losses since inception. |
Leases | Leases The Company determines if a contract contains a lease at the inception of the contract. The Company currently has leases related to its facilities leased for office and laboratory space, which are classified as operating leases. These leases result in operating right-of-use (ROU) assets, current operating lease liabilities, and non-current operating lease liabilities in the Company’s consolidated balance sheets. The Company does not have any financing leases. Leases with a term of 12 months or less are considered short-term and ROU assets and lease obligations are not recognized. Payments associated with short-term leases are expensed on a straight-line basis over the lease term. Lease liabilities represent an obligation to make lease payments arising from the lease and ROU assets represent the right to use the underlying asset identified in the lease for the lease term. Lease liabilities are measured at the present value of the lease payments not yet paid discounted using the discount rate for the lease established at the lease commencement date. To determine the present value, the implicit rate is used when readily determinable. For those leases where the implicit rate is not provided, the Company determines an incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. ROU assets are measured as the present value of the lease payments and also include any prepaid lease payments made and any other indirect costs incurred, and exclude any lease incentives received. Lease terms may include the impact of options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company aggregates all lease and non-lease components for each class of underlying assets into a single lease component. |
Collaborative Arrangements | Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements ("ASC 808"), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and its collaboration partner are within the scope of other accounting literature, including ASC Topic 606, Revenue from Contracts with Customers ("ASC 606"). If it is concluded that some or all aspects of the arrangement represent a transaction with a customer, the Company will account for those aspects of the arrangement within the scope of ASC 606. ASC 808 provides guidance for the presentation and disclosure of transactions in collaborative arrangements, but it does not provide recognition or measurement guidance. Therefore, if the Company concludes a counterparty to a transaction is not a customer or otherwise not within the scope of ASC 606, the Company considers the guidance in other accounting literature as applicable or by analogy to account for such transaction. The classification of transactions under the Company’s arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the Company follows a five-step approach for arrangements that are attributable to ASC 606 - Revenues from customers: (i) identify the contract 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, and (v) recognize revenue when (or as) the customer obtains control of the product or service. The Company considers the terms of a contract and all relevant facts and circumstances when applying the revenue recognition standard. The Company applies the revenue recognition standard, including the use of any practical expedients, consistently to contracts with similar characteristics and in similar circumstances. A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product or the service to be transferred can be identified, (iii) the payment terms for the product or the service to be transferred can be identified, (iv) the contract must have commercial substance (that is, the risk, timing or amount of future cash flows is expected to change as a result of the contract), and (v) it is probable that the Company will collect substantially all of the consideration to which it is entitled to receive in exchange for the transfer of the product or the service. A performance obligation is defined as a promise to transfer a product or a service to a customer. The Company identifies each promise to transfer a product or a service (or a bundle of products or services, or a series of products and services that are substantially the same and have the same pattern of transfer) that is distinct. A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract. Each distinct promise to transfer a product or a service is a unit of accounting for revenue recognition. If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation. The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer. To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer. If a significant financing component exists, the transaction price is adjusted for the time value of money. If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer. There are two methods for determining the amount of variable consideration: (i) the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts, and (ii) the mostly likely amount method, which identifies the single most likely amount in a range of possible consideration amounts. If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation. In those instances where the Company first receives consideration in advance of satisfying its performance obligation, the Company classifies such consideration as deferred revenue until (or as) the Company satisfies such performance obligation. In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable. The Company expenses incremental costs of obtaining and fulfilling a contract as and when incurred if the expected amortization period of the asset that would be recognized is one year or less, or if the amount of the asset is immaterial. Otherwise, such costs are capitalized as contract assets if they are incremental to the contract and amortized to expense proportionate to revenue recognition of the underlying contract . |
Stock Price Appreciation Milestones | Stock Price Appreciation Milestones The Company estimates the fair value of the stock price appreciation milestones associated with the Amended and Restated Exclusive License Agreement with Memorial Sloan Kettering Cancer Center, using a Monte Carlo simulation model, which relies on the Company’s current stock price as well as significant estimates and assumptions to determine the estimated liability associated with the contingent milestone payments. The Company accounts for the fair value of the stock price appreciation milestones in accordance with ASC 815, Derivatives and Hedging , with fair value marked to market at each reporting date. The assumptions used to calculate the fair value of the stock price appreciation milestones are subject to a significant amount of judgment including the probability of achieving a specified clinical milestone, the expected volatility of the Company’s common stock, the risk-free interest rate, and the estimated term, which is based in part on the last valid patent claim date. The Company remeasures the fair value of the stock price appreciation milestones at each balance sheet date, with changes in fair value recorded in earnings as non-operating income or expense on the consolidated statements of operations and comprehensive loss. |
Research and Development Costs | Research and Development Costs All research and development costs are expensed as incurred. |
Patent Costs | Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee stock option and restricted stock unit grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. Performance-based stock units/awards represent a right to receive a certain number of shares of common stock based on the achievement of corporate performance goals and continued employment during the vesting period. At each reporting period, and to the extent achievement of one or any of the performance conditions is probable, the Company reassesses the probability of the achievement of such corporate performance goals and any increase or decrease in share-based compensation expense resulting from an adjustment in the estimated shares to be released is treated as a cumulative catch-up in the period of adjustment. For stock awards for which vesting is subject to both performance-based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance-based milestone is probable or the performance condition has been achieved. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, with the exception of option grants for which vesting is subject to both performance-based milestones and market conditions, which are valued using a lattice-based model. The fair value of restricted stock units, including performance-based restricted stock units, is based on the closing price of the Company’s common stock as reported on The Nasdaq Global Market on the date of grant. The Company recognizes forfeitures for all awards as such forfeitures occur . |
Convertible Preferred Stock | Convertible Preferred Stock The Company applies the relevant accounting standards to distinguish liabilities from equity when assessing the classification and measurement of preferred stock. Preferred shares subject to mandatory redemptions are considered liabilities and measured at fair value. Conditionally redeemable preferred shares are considered temporary equity. All other preferred shares are considered as stockholders’ equity. The Company applies the relevant accounting standards for derivatives and hedging (in addition to distinguishing liabilities from equity) when accounting for hybrid contracts that contain conversion options. Conversion options must be bifurcated from the host instruments and accounted for as free-standing financial instruments according to certain criteria. These criteria include circumstances when (i) the economic characteristics and risks of the embedded derivative instruments are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable accounting principles with changes in fair value reported in earnings as they occurred, and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently measured at fair value at each reporting date, with the changes in fair value reported in earnings. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more- likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. |
Employee Retention credit | Employee Retention Credit The CARES Act provides an employee retention credit (ERC), which is a refundable tax credit against certain employment taxes of up to $ 5,000 per employee for eligible employers. The tax credit is equal to 50 % of qualified wages paid to employees during a quarter, capped at $ 10,000 of qualified wages per employee through December 31, 2020. Additional relief provisions were passed by the United States government, which extend and slightly expand the qualified wage caps on these credits through December 31, 2021. Based on these additional provisions, the tax credit is now equal to 70 % of qualified wages paid to employees during a quarter, and the limit on qualified wages per employee has been increased to $ 10,000 of qualified wages per quarter. The Company qualifies for the tax credit under the CARES Act and expects to continue to receive additional tax credits under the additional relief provisions for qualified wages through December 31, 2021. In connection with the CARES Act, the Company adopted a policy to recognize the employee retention credit when received and include in other income in the statement of operations. Accordingly, the Company received a cash payment and recorded $ 0.5 million of other income during the year ended December 31, 2022 . The Company did not receive or record other income during the years ended December 31, 2021 or 2020 . |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non‑owner sources. Other comprehensive loss includes unrealized gains and losses, other than losses attributable to a credit loss which are included in other income and expense, on investments classified as available-for-sale securities, which was the only difference between net loss and comprehensive loss for the applicable periods. |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. The Pre-Funded Warrants associated with the January 2021 public equity offering (see Note 9) are considered outstanding shares in the basic earnings per share calculation given their nominal exercise price. Dilutive common stock equivalents comprise convertible preferred stock, warrants for the purchase of common stock, and common stock options and restricted stock units outstanding under the Company’s stock option plans. For all periods presented, there is no difference in the number of common shares used to calculate basic and diluted common shares outstanding due to the Company’s net loss position. Potentially dilutive securities that are not included in the calculation of diluted net loss per common share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): As of December 31, 2022 2021 2020 Common stock options 7,267,226 7,708,263 10,432,822 Restricted stock units 5,862,733 4,008,832 1,401,732 Series A convertible preferred stock (if converted) 13,972,745 13,972,745 13,972,745 Total 27,102,704 25,689,840 25,807,299 |
Going Concern Assessment | Going Concern Assessment Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year from the financial statement issuance date. The Company determined that there are no conditions or events that raise substantial doubt about its ability to continue as a going concern for a period of at least twelve months from the date of issuance of these financial statements . |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows as of December 31, 2022, 2021 and 2020 (in thousands): Years Ended December 31, 2022 2021 2020 Cash and cash equivalents $ 61,333 $ 133,583 $ 167,347 Restricted cash 15,227 15,227 15,227 Total cash, cash equivalents, and restricted cash shown in the consolidated statement of cash flows $ 76,560 $ 148,810 $ 182,574 |
Schedule of Anti-Dilutive Securities not Included in Calculation of Diluted Net Loss Per Common Share | Potentially dilutive securities that are not included in the calculation of diluted net loss per common share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): As of December 31, 2022 2021 2020 Common stock options 7,267,226 7,708,263 10,432,822 Restricted stock units 5,862,733 4,008,832 1,401,732 Series A convertible preferred stock (if converted) 13,972,745 13,972,745 13,972,745 Total 27,102,704 25,689,840 25,807,299 |
Collaboration and License Agr_2
Collaboration and License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Collaboration And License Agreements Disclosure [Abstract] | |
Summary of All Possible Stock Price Appreciation Milestone Payments | The following table summarizes the common stock multiples and the stock price appreciation milestone payments under the terms of the agreement : Common stock multiple 5.0x 10.0x 15.0x Ten-trading day trailing average common stock price $ 50.18 $ 100.36 $ 150.54 Stock price appreciation milestone payment (in millions) $ 20.0 $ 30.0 $ 25.0 |
Schedule of Assumptions Used to Determine the Estimated Fair Value of the Stock Price Appreciation Milestone Payments | Year Ended Year Ended 2022 2021 Risk-free interest rate 4.0 % 1.7 % Expected volatility 78.1 % 77.6 % Estimated term (in years) 16.0 17.0 Closing stock price as of measurement date $ 10.09 $ 58.51 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments [Abstract] | |
Summary of Investments | The following table summarizes the Company’s investments accounted for as available-for-sale securities as of December 31, 2022 and 2021 (in thousands): Maturity Amortized Unrealized Unrealized Estimated December 31, 2022 Classified as current assets: U.S. Treasury debt securities 1 or less $ 79,251 $ ( 263 ) $ 37 $ 79,025 Non-US government securities 1 or less 2,425 ( 2 ) — 2,423 Municipal securities 1 or less 18,963 ( 208 ) — 18,755 Corporate debt securities 1 or less 123,996 ( 1,138 ) 3 122,861 Commercial paper 1 or less 152,056 ( 230 ) 4 151,830 Total short-term investments $ 376,691 $ ( 1,841 ) $ 44 $ 374,894 Classified as non-current assets: Municipal securities Greater than 1 $ 5,000 $ ( 58 ) $ — $ 4,942 Total long-term investments $ 5,000 $ ( 58 ) $ — $ 4,942 December 31, 2021 Classified as current assets: U.S. Treasury debt securities 1 or less $ 70,653 $ ( 163 ) $ — $ 70,490 Municipal securities 1 or less 18,017 ( 6 ) 1 18,012 Corporate debt securities 1 or less 169,736 ( 187 ) — 169,549 Commercial paper 1 or less 224,333 ( 59 ) 2 224,276 Total short-term investments $ 482,739 $ ( 415 ) $ 3 $ 482,327 Classified as non-current assets: U.S. Treasury debt securities Greater than 1 $ 9,989 $ ( 35 ) $ — $ 9,954 Municipal securities Greater than 1 9,034 ( 42 ) — 8,992 Corporate debt securities Greater than 1 81,989 ( 271 ) — 81,718 Total long-term investments $ 101,012 $ ( 348 ) $ — $ 100,664 |
Aggregated by investment category and the length of time | aggregated by investment category and the length of time that individual securities have been in a continuous loss position (in thousands): Less Than 12 Months 12 Months or Greater Total Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses December 31, 2022 U.S. Treasury debt securities $ 51,246 $ ( 163 ) $ 9,898 $ ( 100 ) $ 61,144 $ ( 263 ) Non-US government securities 2,424 ( 2 ) — — 2,424 ( 2 ) Municipal securities 14,765 ( 193 ) 8,933 ( 73 ) 23,698 ( 266 ) Corporate debt securities 45,621 ( 174 ) 71,625 ( 964 ) 117,246 ( 1,138 ) Commercial paper 66,455 ( 230 ) — — 66,455 ( 230 ) Total $ 180,511 $ ( 762 ) $ 90,456 $ ( 1,137 ) $ 270,967 $ ( 1,899 ) December 31, 2021 U.S. Treasury debt securities $ 80,444 $ ( 198 ) $ — $ — $ 80,444 $ ( 198 ) Municipal securities 23,352 ( 48 ) — — 23,352 ( 48 ) Corporate debt securities 250,467 ( 458 ) — — 250,467 ( 458 ) Commercial paper 59,863 ( 59 ) — — 59,863 ( 59 ) Total $ 414,126 $ ( 763 ) $ — $ — $ 414,126 $ ( 763 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured at Fair Value on Recurring Basis | The following tables presents the Company’s financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2022 and 2021 (in thousands): Fair Value Measurements at Total Quoted Prices Significant Significant As of December 31, 2022: Financial assets: Money market funds $ 61,333 $ 61,333 $ — $ — U.S. Treasury debt securities 79,025 79,025 — — Non-US government securities 2,423 — 2,423 — Municipal securities 23,697 — 23,697 — Corporate debt securities 122,861 — 122,861 — Commercial paper 151,830 — 151,830 — Total assets measured at fair value on a recurring basis $ 441,169 $ 140,358 $ 300,811 $ — Financial liabilities: Stock price appreciation milestones $ 3,861 $ — $ — $ 3,861 Total financial liabilities measured at fair value on a recurring basis $ 3,861 $ — $ — $ 3,861 As of December 31, 2021: Financial assets: Money market funds $ 133,583 $ 133,583 $ — $ — U.S. Treasury debt securities 80,444 80,444 — — Municipal securities 27,004 — 27,004 — Corporate debt securities 251,267 — 251,267 — Commercial paper 224,276 — 224,276 — Total assets measured at fair value on a recurring basis $ 716,574 $ 214,027 $ 502,547 $ — Financial liabilities: Stock price appreciation milestones $ 24,168 $ — $ — $ 24,168 Total financial liabilities measured at fair value on a recurring basis $ 24,168 $ — $ — $ 24,168 |
Summary of Changes in the Fair Value of the Company’s Level 3 Enterprise Fair Value Milestone Payment Liability | The following table presents the changes in fair value of the Company’s Level 3 stock price appreciation milestones liability (in thousands): Balance at December 31, 2021 $ 24,168 Changes in fair value of stock price appreciation milestones liability ( 20,307 ) Balance at December 31, 2022 $ 3,861 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | Property and equipment consist of the following (in thousands): December 31, 2022 2021 Furniture and fixtures $ 1,209 $ 1,209 Computer and office equipment 2,937 2,168 Software 2,122 1,899 Leasehold improvements—building 56,782 52,948 Scientific equipment 77,354 50,250 Total property and equipment, gross 140,404 108,474 Less accumulated depreciation and amortization ( 30,384 ) ( 16,945 ) Total property and equipment, net $ 110,020 $ 91,529 |
Accrued Expenses and Long-Ter_2
Accrued Expenses and Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses And Long Term Debt Disclosure [Abstract] | |
Schedule of accrued expenses | Current accrued expenses consist of the following (in thousands): December 31, 2022 2021 Accrued payroll and other employee benefits $ 17,899 $ 18,358 Accrued clinical trial related costs 16,858 12,344 Accrued other 19,175 11,710 Total current accrued expenses $ 53,932 $ 42,412 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense for the years ended December 31, 2022, 2021, and 2020 were as follows (in thousands): Years Ended 2022 2021 2020 Straight-line lease expense $ 15,010 $ 15,354 $ 12,076 Variable lease expense 2,614 1,660 2,245 Total operating lease expense $ 17,624 $ 17,014 $ 14,321 |
Schedule of Future Minimum Payments Under Non-cancelable Operating Leases | Future undiscounted minimum payments under the Company’s operating leases as of December 31, 2022 are as follows (in thousands): Operating Years Ending December 31, 2023 $ 14,597 2024 14,836 2025 15,087 2026 15,540 2027 16,006 Thereafter 101,636 Total undiscounted lease payments $ 177,702 Less: imputed interest ( 68,364 ) Total lease liability $ 109,338 |
Convertible Preferred Stock a_2
Convertible Preferred Stock and Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Convertible Preferred Stock And Stockholders Deficit Disclosure [Abstract] | |
Summary of stock option activity and related information under all equity plans | The following table summarizes stock option activity and related information under all equity plans for the year ended December 31, 2022: Options Weighted Weighted Aggregate Outstanding at December 31, 2021 7,708,263 $ 20.43 Granted 848,457 36.68 Exercised ( 941,780 ) 9.74 Cancelled ( 347,714 ) 48.56 Outstanding at December 31, 2022 7,267,226 $ 22.37 6.30 $ 7,577 Options vested and expected to vest at December 31, 2022 7,267,226 $ 22.37 6.30 $ 7,577 Options exercisable at December 31, 2022 5,722,035 $ 18.20 5.79 $ 7,577 |
Summary of restricted stock unit activity and related information under all equity plans | The following table summarizes restricted stock unit activity and related information under all equity plans for the year ended December 31, 2022: Number of Weighted Weighted Aggregate Outstanding at December 31, 2021 4,008,832 $ 58.60 Granted 3,211,208 36.58 Vested ( 626,175 ) 53.44 Cancelled ( 731,132 ) 51.46 Outstanding at December 31, 2022 5,862,733 $ 48.13 3.13 $ 59,155 Restricted stock units expected to vest at December 31, 2022 4,065,114 $ 44.46 2.75 $ 41,017 |
Schedule of allocation of stock-based compensation for all stock awards | The allocation of stock-based compensation for all stock awards is as follows (in thousands): Years Ended 2022 2021 2020 Research and development $ 51,103 $ 35,140 $ 18,636 General and administrative 27,630 19,224 12,117 Total stock-based compensation expense $ 78,733 $ 54,364 $ 30,753 |
Schedule of weighted-average assumptions used to determine the fair value of employee and nonemployee stock option grants | he weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee and nonemployee stock option grants were as follows: Years Ended 2022 2021 2020 Risk–free interest rate 1.9 % 0.5 % 1.0 % Expected volatility 76.2 % 76.5 % 77.5 % Expected term (in years) 5.8 5.1 5.5 Expected dividend yield 0.0 % 0.0 % 0.0 % |
Schedule of common stock reserved for future issuance | Common stock reserved for future issuance is as follows: December 31, 2022 2021 Convertible preferred stock (if converted) 13,972,745 13,972,745 Common stock options 7,267,226 7,708,263 Restricted stock units 5,862,733 4,008,832 Awards available under the 2013 Plan — 3,356,946 Awards available under the 2022 Plan 10,274,169 — Awards available under the Inducement Plan 741,000 856,000 Employee stock purchase plan 729,000 729,000 Total 38,846,873 30,631,786 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of reconciliation of the Company's expected federal income tax provision (benefit) to the actual income tax provision | The following is a reconciliation of the Company’s expected federal income tax provision (benefit) to the actual income tax provision (in thousands): Years Ended December 31, 2022 2021 2020 Tax computed at federal statutory rate $ ( 59,161 ) $ ( 44,551 ) $ ( 36,411 ) State tax, net of federal tax benefit ( 11,109 ) ( 6,966 ) ( 1,296 ) Non-deductible compensation 2,086 10,202 75 Permanent differences ( 1,340 ) ( 686 ) ( 240 ) Stock compensation 3,356 ( 35,852 ) ( 6,073 ) R&D tax credits ( 14,484 ) ( 12,140 ) ( 7,177 ) Reserve for uncertain tax positions 12,564 7,192 1,555 Other ( 1,376 ) 84 70 Valuation allowance 69,464 82,717 49,497 Income tax expense $ — $ — $ — |
Summary of significant components of the Company's deferred tax assets | Significant components of the Company’s deferred tax assets are summarized as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Capitalized R&D expense $ 127,250 $ 95,172 Net operating losses 84,608 62,913 R&D tax credits 49,736 35,387 Intangible asset amortization 8,012 6,985 Deferred revenue 8,714 8,706 Stock compensation 13,128 8,710 Lease liability 22,961 24,112 Other 2,526 6,972 Total deferred tax assets 316,935 248,957 Deferred tax liabilities: Depreciation ( 6,814 ) ( 7,323 ) Right-of-use assets ( 13,874 ) ( 14,851 ) Total deferred tax liabilities ( 20,688 ) ( 22,174 ) Net of deferred tax assets and liabilities 296,247 226,783 Valuation allowance ( 296,247 ) ( 226,783 ) Net deferred tax assets $ — $ — |
Summary of the change in the Company's unrecognized tax benefits | The change in the Company’s unrecognized tax benefits is summarized as follows (in thousands): December 31, 2022 2021 2020 Beginning unrecognized tax benefits $ 37,255 $ 19,779 $ 16,822 Increase related to current year tax positions 9,101 17,557 1,837 Increase related to prior year tax positions 6,411 — 1,120 Decrease related to prior year tax positions — ( 81 ) — Ending unrecognized tax benefits $ 52,767 $ 37,255 $ 19,779 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2021 USD ($) $ / shares shares | Jun. 30, 2020 USD ($) $ / shares shares | Apr. 30, 2020 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) Disbursement shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) shares | |
Organization and summary of significant accounting policies | ||||||
Aggregate purchase price of common stock | $ 432,281 | $ 188,784 | ||||
Number of operating segments | Disbursement | 1 | |||||
Number of reportable segments | Disbursement | 1 | |||||
Letters of credit outstanding amount | $ 15,200 | $ 15,200 | $ 15,200 | |||
Maximum | ||||||
Organization and summary of significant accounting policies | ||||||
Short-term leases term excluded from calculation of ROU and lease liabilities | 12 months | |||||
Employee Retention Credit [Member] | ||||||
Organization and summary of significant accounting policies | ||||||
Percentage Of Tax Credit | 70% | 50% | ||||
Payments To Employees | $ 10,000 | $ 10,000 | ||||
Other Income | $ 500 | |||||
Employee Retention Credit [Member] | Maximum | ||||||
Organization and summary of significant accounting policies | ||||||
RefundableTaxCredit | $ 5,000 | |||||
Pre-Funded Warrants | ||||||
Organization and summary of significant accounting policies | ||||||
Number of shares to be purchased | shares | 257,310 | 257,310 | ||||
Purchase price of prefunded warrants | $ / shares | $ 85.499 | |||||
Exercise price of warrants | $ / shares | $ 0.001 | |||||
Common Stock | ||||||
Organization and summary of significant accounting policies | ||||||
Public offerings of common stock, net of offering costs (in shares) | shares | 5,122,807 | 7,108,796 | ||||
Aggregate purchase price of common stock | $ 5 | $ 7 | ||||
June 2020 Public Offering | ||||||
Organization and summary of significant accounting policies | ||||||
Public offerings of common stock, net of offering costs (in shares) | shares | 7,100,000 | |||||
Share issue price (in dollars per share) | $ / shares | $ 28.31 | |||||
Costs related to equity offering | $ 12,500 | |||||
Aggregate purchase price of common stock | 201,300 | |||||
Net proceeds from issuance of shares after related cash costs | $ 188,800 | |||||
January 2021 Public Equity Offering | ||||||
Organization and summary of significant accounting policies | ||||||
Public offerings of common stock, net of offering costs (in shares) | shares | 5,100,000 | |||||
Share issue price (in dollars per share) | $ / shares | $ 85.50 | |||||
Costs related to equity offering | $ 27,600 | |||||
Aggregate purchase price of common stock | 460,000 | |||||
Net proceeds from issuance of shares after related cash costs | $ 432,400 | |||||
Private Placement | Johnson Johnson Innovation J J D C Inc | Common Stock | ||||||
Organization and summary of significant accounting policies | ||||||
Share issue price (in dollars per share) | $ / shares | $ 28.31 | |||||
Aggregate purchase price of common stock | $ 50,000 | |||||
Issuance of common stock during period for private placements (in shares) | shares | 1,800,000 | |||||
Net proceeds from issuance of shares after related cash costs | $ 50,000 | |||||
Private Placement | Stock Purchase Agreement | Johnson Johnson Innovation J J D C Inc | Common Stock | ||||||
Organization and summary of significant accounting policies | ||||||
Share issue price (in dollars per share) | $ / shares | $ 31 | |||||
Issuance of common stock during period for private placements (in shares) | shares | 1,600,000 | |||||
Net proceeds from issuance of shares after related cash costs | $ 50,000 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies (Details 1) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 61,333 | $ 133,583 | $ 167,347 | |
Restricted cash | 15,227 | 15,227 | 15,227 | |
Total cash, cash equivalents, and restricted cash shown in the consolidated statement of cash flows | $ 76,560 | $ 148,810 | $ 182,574 | $ 100,041 |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies (Details 2) - Scientific Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Minimum | |
Property and equipment | |
Estimated useful lives | 2 years |
Maximum | |
Property and equipment | |
Estimated useful lives | 5 years |
Organization and Summary of S_7
Organization and Summary of Significant Accounting Policies (Details 3) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Net Loss per Common Share [Abstract] | |||
Uncertain tax position description | more than 50 percent | ||
Anti-dilutive securities (in shares) | 27,102,704 | 25,689,840 | 25,807,299 |
Common Stock Options | |||
Net Loss per Common Share [Abstract] | |||
Anti-dilutive securities (in shares) | 7,267,226 | 7,708,263 | 10,432,822 |
Restricted Stock Units (RSUs) | |||
Net Loss per Common Share [Abstract] | |||
Anti-dilutive securities (in shares) | 5,862,733 | 4,008,832 | 1,401,732 |
Series A Convertible Preferred Stock (if converted) | |||
Net Loss per Common Share [Abstract] | |||
Anti-dilutive securities (in shares) | 13,972,745 | 13,972,745 | 13,972,745 |
Collaboration and License Agr_3
Collaboration and License Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||||||||
Nov. 07, 2022 | Sep. 14, 2022 | May 26, 2022 | Apr. 07, 2020 | Apr. 02, 2020 | Sep. 14, 2018 | Sep. 14, 2018 | Jun. 30, 2022 | Jun. 30, 2020 | Oct. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jul. 31, 2021 | Dec. 04, 2020 | |
Collaboration agreement | ||||||||||||||||
Aggregate purchase price of common stock | $ 432,281,000 | $ 188,784,000 | ||||||||||||||
Proceeds from private placement of common stock, net of issuance costs | $ 0 | 0 | 49,975,000 | |||||||||||||
Collaboration contract asset | 7,196,000 | 9,870,000 | ||||||||||||||
Revenue recognized | 96,300,000 | $ 55,846,000 | 31,434,000 | |||||||||||||
Milestone Recorded to Deferred Revenue With Remaining Unrecognized Revenue | $ 3,000,000 | |||||||||||||||
Expected ressarch services period | 4 years | |||||||||||||||
Common stock, issued shares | 97,294,917 | 95,726,962 | ||||||||||||||
Research and development | $ 320,454,000 | $ 215,519,000 | 125,623,000 | |||||||||||||
Research And Development | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Revenue recognized | 42,300,000 | |||||||||||||||
Janssen Agreement | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Sublicense Consideration Represents an Asset Under ASC, Other Assets and Deferred Costs | 17,100,000 | |||||||||||||||
Research and development fees cash payments received | $ 3,000,000 | |||||||||||||||
First Janssen Cancer Target | Maximum | Janssen Agreement | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Development, regulatory, and sales milestones | $ 898,000,000 | |||||||||||||||
Additional candidate milestone Payments | 460,000,000 | |||||||||||||||
Additional Cancer Targets | Maximum | Janssen Agreement | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Development, regulatory, and sales milestones | 706,000,000 | |||||||||||||||
Additional candidate milestone Payments | $ 340,000,000 | |||||||||||||||
Johnson Johnson Innovation J J D C Inc | Stock Purchase Agreement | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Issuance of common stock during period for private placements (in shares) | 1,600,000 | |||||||||||||||
Common stock per share | $ 31 | |||||||||||||||
Aggregate purchase price of common stock | $ 50,000,000 | |||||||||||||||
Equity premium per share | $ 9.93 | |||||||||||||||
Aggregate equity premium on shares | $ 16,000,000 | |||||||||||||||
Proceeds from private placement of common stock, net of issuance costs | 34,000,000 | |||||||||||||||
Johnson Johnson Innovation J J D C Inc | Stock Purchase Agreement | Private Placement | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Issuance of common stock during period for private placements (in shares) | 1,800,000 | |||||||||||||||
Proceeds from private placement of common stock, net of issuance costs | $ 50,000,000 | |||||||||||||||
Aggregate value of common stock | $ 50,000,000 | |||||||||||||||
Share issue price (in dollars per share) | $ 28.31 | |||||||||||||||
Janssen Biotech Inc | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Upfront, non-refundable and non-creditable payment | 50,000,000 | $ 50,000,000 | ||||||||||||||
Transaction price of the agreement | 66,000,000 | |||||||||||||||
Equity premium | 16,000,000 | |||||||||||||||
Non-refundable upfront payments recorded as deferred revenue | 66,000,000 | |||||||||||||||
Collaboration contract asset | $ 17,100,000 | 7,200,000 | ||||||||||||||
Amortization of sublicense consideration | 4,300,000 | 1,700,000 | ||||||||||||||
Revenue recognized | 79,700,000 | 43,700,000 | ||||||||||||||
Deferred revenue | 41,200,000 | |||||||||||||||
Collaboration services | 1,300,000 | |||||||||||||||
Research and development fees cash payments received | 70,400,000 | |||||||||||||||
Contract with Customer, Liability, Revenue Recognized | 6,000,000 | |||||||||||||||
Option Exercise Payment | $ 10,000,000 | $ 10,000,000 | ||||||||||||||
Janssen Biotech Inc | Research And Development | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Revenue recognized | 29,500,000 | |||||||||||||||
Option Exercise Payment | 13,000,000 | |||||||||||||||
Janssen Biotech Inc | Upfront Fee and Equity Premium | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Revenue recognized | 23,100,000 | 14,200,000 | ||||||||||||||
Ono Pharmaceutical Company Ltd | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Transaction price of the agreement | $ 39,300,000 | |||||||||||||||
Non-refundable upfront payments recorded as deferred revenue | $ 10,000,000 | 10,000,000 | $ 10,000,000 | |||||||||||||
Collaboration contract asset | 7,800,000 | |||||||||||||||
Amortization of sublicense consideration | 4,100,000 | 1,200,000 | ||||||||||||||
Revenue recognized | 16,600,000 | 12,100,000 | 14,600,000 | |||||||||||||
Deferred revenue | 1,100,000 | |||||||||||||||
Research and development fees cash payments received | 21,900,000 | |||||||||||||||
Option Exercise Payment | $ 12,500,000 | 12,500,000 | ||||||||||||||
Collaborative Arrangement First Year Research And Development Fees Prepayment | $ 5,000,000 | |||||||||||||||
Milestone payments | $ 10,000,000 | |||||||||||||||
Aggregate research and development fees payments receivable | 29,300,000 | 29,300,000 | $ 20,000,000 | |||||||||||||
Non-refundable upfront payments recorded as deferred revenue | $ 10,000,000 | 10,000,000 | ||||||||||||||
Collaborative arrangement annual payments receivable recorded as deferred revenue | $ 5,000,000 | |||||||||||||||
Ono Pharmaceutical Company Ltd | Candidate 2 | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Percentage of reduction on milestone payments | 50% | |||||||||||||||
Ono Pharmaceutical Company Ltd | Collaborative Arrangement | Research services | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Revenue recognized | 6,000,000 | 5,700,000 | ||||||||||||||
Ono Pharmaceutical Company Ltd | Collaborative Arrangement | Upfront Fee | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Revenue recognized | 1,600,000 | 6,100,000 | 2,800,000 | |||||||||||||
Ono Pharmaceutical Company Ltd | Maximum | Candidate 2 | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Aggregate milestone payments | $ 843,000,000 | |||||||||||||||
Ono Pharmaceutical Company Ltd | Maximum | Candidate 1 | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Collaborative arrangement potential additional milestones | $ 29,300 | |||||||||||||||
Ono Pharmaceutical Company Ltd | Minimum | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Profits and losses sharing percentage | 50% | |||||||||||||||
Ono Pharmaceutical Company Ltd | Minimum | Candidate 1 | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Profits and losses sharing percentage | 50% | |||||||||||||||
Collaborative arrangement potential additional milestones | $ 9,300,000 | |||||||||||||||
Ono Pharmaceutical Company Ltd | Ono Letter Agreement | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Revenue recognized | 2,500,000 | 6,000,000 | ||||||||||||||
Milestone payments | 10,000,000 | |||||||||||||||
Milestone payments recorded to deferred revenue | $ 10,000,000 | $ 10,000,000 | ||||||||||||||
Ono Pharmaceutical Company Ltd | Ono Letter Agreement | Sublicense Consideration | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Sublicense consideration paid | 7,800,000 | |||||||||||||||
Amended MSK License | ||||||||||||||||
Collaboration agreement | ||||||||||||||||
Stock price appreciation milestones potential payments | 75,000,000 | |||||||||||||||
Stock price appreciation milestone, income | 20,300,000 | 3,500,000 | ||||||||||||||
Stock price appreciation milestone, expense | $ 47,700,000 | |||||||||||||||
Stock price appreciation milestone payable | $ 20,000,000 | |||||||||||||||
Enterprise Value Milestones Liability At Fair Value | $ 3,900,000 | $ 24,200,000 |
Collaboration and License Agr_4
Collaboration and License Agreements (Details 1) - Amended MSK License $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares | |
Milestone One | |
Collaboration agreement | |
Common stock multiple | 5.0x |
Ten-trading day trailing average common stock price | $ / shares | $ 50.18 |
Stock price appreciation milestone payment | $ | $ 20 |
Milestone Two | |
Collaboration agreement | |
Common stock multiple | 10.0x |
Ten-trading day trailing average common stock price | $ / shares | $ 100.36 |
Stock price appreciation milestone payment | $ | $ 30 |
Milestone Three | |
Collaboration agreement | |
Common stock multiple | 15.0x |
Ten-trading day trailing average common stock price | $ / shares | $ 150.54 |
Stock price appreciation milestone payment | $ | $ 25 |
Collaboration and License Agr_5
Collaboration and License Agreements (Details 2) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Determine the estimated fair value of the enterprise value milestone payments | ||
Closing stock price as of measurement date | $ 10.09 | |
Amended MSK License | ||
Determine the estimated fair value of the enterprise value milestone payments | ||
Risk-free interest rate | 4% | 1.70% |
Expected volatility | 78.10% | 77.60% |
Estimated term (in years) | 16 years | 17 years |
Closing stock price as of measurement date | $ 10.09 | $ 58.51 |
California Institute For Rege_2
California Institute For Regenerative Medicine Award (Details) - USD ($) $ in Millions | 12 Months Ended | |
Apr. 05, 2018 | Dec. 31, 2022 | |
Award from California institute for regenerative medicine | ||
Period to treat award as grant, if award not treated as loan | 10 years | |
California Institute for Regenerative Medicine | ||
Award from California institute for regenerative medicine | ||
Receipt of first disbursement under the Award | $ 4 | |
California Institute for Regenerative Medicine | LIBOR | ||
Award from California institute for regenerative medicine | ||
Award considered as a loan, interest rate | 7% | |
California Institute for Regenerative Medicine | Loan Repayment Rate One | ||
Award from California institute for regenerative medicine | ||
Repayment percentage of award amount | 60% | |
California Institute for Regenerative Medicine | Loan Repayment Rate Two | ||
Award from California institute for regenerative medicine | ||
Repayment percentage of award amount | 80% | |
California Institute for Regenerative Medicine | Loan Repayment Rate Three | ||
Award from California institute for regenerative medicine | ||
Repayment percentage of award amount | 100% | |
California Institute for Regenerative Medicine | Loan Repayment Rate Four | ||
Award from California institute for regenerative medicine | ||
Repayment percentage of award amount | 100% | |
California Institute for Regenerative Medicine | FT516 | ||
Award from California institute for regenerative medicine | ||
Award agreement executed date | Apr. 05, 2018 | |
Award for first-in-human clinical trial | $ 4 |
Investments (Details)
Investments (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule Of Available For Sale Securities [Line Items] | |||||
Available-for-sale securities, impairment | $ 0 | $ 0 | $ 0 | ||
Available-for-sale securities, realized gains (losses) on sales | $ 0 | $ 0 | 0 | ||
Available-for-sale securities, recognition of expected credit losses | 0 | 0 | $ 0 | ||
Prepaid Expenses And Other Assets | |||||
Schedule Of Available For Sale Securities [Line Items] | |||||
Accured Interest on investments | $ 800,000 | $ 1,100,000 | |||
Treasuries, Commercial paper. Non US government securities and Corporate Debt Securities | |||||
Schedule Of Available For Sale Securities [Line Items] | |||||
Short term investments, maturity start range | 3 months | ||||
Short term investments, maturity end range | 36 months |
Investments (Details 2)
Investments (Details 2) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
U.S. Treasury debt securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 79,251 | $ 70,653 |
Unrealized Losses | (263) | (163) |
Unrealized Gains | 37 | 0 |
Estimated Fair Value | $ 79,025 | $ 70,490 |
U.S. Treasury debt securities | Non-current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | Greater than 1 | |
Amortized Cost | $ 9,989 | |
Unrealized Losses | (35) | |
Unrealized Gains | 0 | |
Estimated Fair Value | $ 9,954 | |
Non-U.S. government securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | |
Amortized Cost | $ 2,425 | |
Unrealized Losses | (2) | |
Unrealized Gains | 0 | |
Estimated Fair Value | $ 2,423 | |
Municipal securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 18,963 | $ 18,017 |
Unrealized Losses | (208) | (6) |
Unrealized Gains | 0 | 1 |
Estimated Fair Value | $ 18,755 | $ 18,012 |
Municipal securities | Non-current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | Greater than 1 | Greater than 1 |
Amortized Cost | $ 5,000 | $ 9,034 |
Unrealized Losses | (58) | (42) |
Unrealized Gains | 0 | 0 |
Estimated Fair Value | $ 4,942 | $ 8,992 |
Corporate debt securities | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 123,996 | $ 169,736 |
Unrealized Losses | (1,138) | (187) |
Unrealized Gains | 3 | 0 |
Estimated Fair Value | $ 122,861 | $ 169,549 |
Corporate debt securities | Non-current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | Greater than 1 | |
Amortized Cost | $ 81,989 | |
Unrealized Losses | (271) | |
Unrealized Gains | 0 | |
Estimated Fair Value | $ 81,718 | |
Commercial Paper | Current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 152,056 | $ 224,333 |
Unrealized Losses | (230) | (59) |
Unrealized Gains | 4 | 2 |
Estimated Fair Value | 151,830 | 224,276 |
Short-term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 376,691 | 482,739 |
Unrealized Losses | (1,841) | (415) |
Unrealized Gains | 44 | 3 |
Estimated Fair Value | 374,894 | 482,327 |
Long-term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 5,000 | |
Unrealized Losses | (58) | |
Unrealized Gains | 0 | |
Estimated Fair Value | $ 4,942 | |
Long-term Investments [Member] | Non-current Assets [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 101,012 | |
Unrealized Losses | (348) | |
Unrealized Gains | 0 | |
Estimated Fair Value | $ 100,664 |
Investment (Details 3) - Short
Investment (Details 3) - Short Term Investment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Total | $ 270,967 | $ 414,126 |
Unrealized Losses, Total | (1,899) | (763) |
Short-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 180,511 | 414,126 |
Unrealized Losses, Less Than 12 Months | (762) | (763) |
Other Long-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 90,456 | 0 |
Unrealized Losses, 12 Months or Greater | (1,137) | 0 |
US Treasury Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Total | 61,144 | 80,444 |
Unrealized Losses, Total | (263) | (198) |
US Treasury Securities [Member] | Short-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 51,246 | 80,444 |
Unrealized Losses, Less Than 12 Months | (163) | (198) |
US Treasury Securities [Member] | Other Long-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 9,898 | 0 |
Unrealized Losses, 12 Months or Greater | (100) | 0 |
Non-U.S. government securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Total | 2,424 | |
Unrealized Losses, Total | (2) | |
Non-U.S. government securities | Short-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 2,424 | |
Unrealized Losses, Less Than 12 Months | (2) | |
Non-U.S. government securities | Other Long-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 0 | |
Unrealized Losses, 12 Months or Greater | 0 | |
Municipal Notes [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Total | 23,698 | 23,352 |
Unrealized Losses, Total | (266) | (48) |
Municipal Notes [Member] | Short-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 14,765 | 23,352 |
Unrealized Losses, Less Than 12 Months | (193) | (48) |
Municipal Notes [Member] | Other Long-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 8,933 | 0 |
Unrealized Losses, 12 Months or Greater | (73) | 0 |
Corporate Debt Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Total | 117,246 | 250,467 |
Unrealized Losses, Total | (1,138) | (458) |
Corporate Debt Securities [Member] | Short-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 45,621 | 250,467 |
Unrealized Losses, Less Than 12 Months | (174) | (458) |
Corporate Debt Securities [Member] | Other Long-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 71,625 | 0 |
Unrealized Losses, 12 Months or Greater | (964) | 0 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Total | 66,455 | 59,863 |
Unrealized Losses, Total | (230) | (59) |
Commercial Paper [Member] | Short-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, Less Than 12 Months | 66,455 | 59,863 |
Unrealized Losses, Less Than 12 Months | (230) | (59) |
Commercial Paper [Member] | Other Long-Term Investments [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value, 12 Months or Greater | 0 | 0 |
Unrealized Losses, 12 Months or Greater | $ 0 | $ 0 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Quoted prices in Active Market for Identical Assets (Level 1) | Money market funds | ||
Financial assets: | ||
Money market funds | $ 61,333 | $ 133,583 |
Quoted prices in Active Market for Identical Assets (Level 1) | U.S. Treasury debt securities | ||
Financial assets: | ||
Estimated Fair Value | 79,025 | 80,444 |
Significant Other Observable Inputs (Level 2) | Non-U.S. government securities | ||
Financial assets: | ||
Estimated Fair Value | 2,423 | |
Significant Other Observable Inputs (Level 2) | Corporate debt securities | ||
Financial assets: | ||
Estimated Fair Value | 122,861 | 251,267 |
Significant Other Observable Inputs (Level 2) | Municipal securities | ||
Financial assets: | ||
Estimated Fair Value | 23,697 | 27,004 |
Significant Other Observable Inputs (Level 2) | Commercial Paper | ||
Financial assets: | ||
Estimated Fair Value | 151,830 | 224,276 |
Fair Value Measurements Recurring | ||
Financial assets: | ||
Total assets measured at fair value on a recurring basis | 441,169 | 716,574 |
Financial liabilities: | ||
Total financial liabilities measured at fair value on a recurring basis | 3,861 | 24,168 |
Fair Value Measurements Recurring | Stock price appreciation milestones | ||
Financial liabilities: | ||
Stock price appreciation milestones | 3,861 | 24,168 |
Fair Value Measurements Recurring | Money market funds | ||
Financial assets: | ||
Money market funds | 61,333 | 133,583 |
Fair Value Measurements Recurring | U.S. Treasury debt securities | ||
Financial assets: | ||
Estimated Fair Value | 79,025 | 80,444 |
Fair Value Measurements Recurring | Non-U.S. government securities | ||
Financial assets: | ||
Estimated Fair Value | 2,423 | |
Fair Value Measurements Recurring | Corporate debt securities | ||
Financial assets: | ||
Estimated Fair Value | 122,861 | 251,267 |
Fair Value Measurements Recurring | Municipal securities | ||
Financial assets: | ||
Estimated Fair Value | 23,697 | 27,004 |
Fair Value Measurements Recurring | Commercial Paper | ||
Financial assets: | ||
Estimated Fair Value | 151,830 | 224,276 |
Fair Value Measurements Recurring | Quoted prices in Active Market for Identical Assets (Level 1) | ||
Financial assets: | ||
Total assets measured at fair value on a recurring basis | 140,358 | 214,027 |
Fair Value Measurements Recurring | Significant Other Observable Inputs (Level 2) | ||
Financial assets: | ||
Total assets measured at fair value on a recurring basis | 300,811 | 502,547 |
Fair Value Measurements Recurring | Significant Unobservable Inputs (Level 3) | ||
Financial assets: | ||
Total assets measured at fair value on a recurring basis | 0 | |
Financial liabilities: | ||
Total financial liabilities measured at fair value on a recurring basis | 3,861 | 24,168 |
Fair Value Measurements Recurring | Significant Unobservable Inputs (Level 3) | Stock price appreciation milestones | ||
Financial liabilities: | ||
Stock price appreciation milestones | $ 3,861 | $ 24,168 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details 2) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Closing stock price as of measurement date | $ 10.09 | ||
Change in fair value of stock price appreciation milestones | $ (20,307) | $ (3,534) | $ 47,702 |
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | 0 | ||
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | 0 | ||
Fair Value, Liabilities, Level 1 to Level 2 Transfers, Amount | 0 | ||
Fair Value, Liabilities, Level 2 to Level 1 Transfers, Amount | 0 | ||
Fair Value Measurements Nonrecurring | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Total assets measured at fair value on a recurring basis | 0 | ||
Total financial liabilities measured at fair value on a recurring basis | $ 0 | ||
Stock price increased by 10% per share | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Sensitivity analysis fair value inputs stock price increase/decrease | 10% | ||
Sensitivity analysis share price fair value input | $ 11.10 | ||
Change in fair value of stock price appreciation milestones | $ 400 | ||
Stock price decreased by 10% per share | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Sensitivity analysis fair value inputs stock price increase/decrease | 10% | ||
Sensitivity analysis share price fair value input | $ 9.08 | ||
Stock price decreased by 10% per share | Fair Value Measurements Nonrecurring | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Change in fair value of stock price appreciation milestones | $ 400 |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details 3) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Change in fair value of stock price appreciation milestones | $ (20,307) | $ (3,534) | $ 47,702 |
Significant Unobservable Inputs (Level 3) | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Balance at the beginning of the period | 24,168 | ||
Change in fair value of stock price appreciation milestones | (20,307) | ||
Balance at the end of the period | $ 3,861 | $ 24,168 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property and equipment | |||
Property and equipment, gross | $ 140,404 | $ 108,474 | |
Less accumulated depreciation and amortization | (30,384) | (16,945) | |
Total property and equipment, net | 110,020 | 91,529 | |
Depreciation expense | 13,758 | 5,850 | $ 3,087 |
Furniture And Fixtures | |||
Property and equipment | |||
Property and equipment, gross | 1,209 | 1,209 | |
Computer And Office Equipment | |||
Property and equipment | |||
Property and equipment, gross | 2,937 | 2,168 | |
Software | |||
Property and equipment | |||
Property and equipment, gross | 2,122 | 1,899 | |
Leasehold improvements-building | |||
Property and equipment | |||
Property and equipment, gross | 56,782 | 52,948 | |
Scientific Equipment | |||
Property and equipment | |||
Property and equipment, gross | $ 77,354 | $ 50,250 |
Property and Equipment (Additio
Property and Equipment (Additional Information) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation expense | $ 13,758 | $ 5,850 | $ 3,087 |
Accrued Expenses and Long-Ter_3
Accrued Expenses and Long-Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current accrued expenses | ||
Accrued payroll and other employee benefits | $ 17,899 | $ 18,358 |
Accrued clinical trial related costs | 16,858 | 12,344 |
Accrued other | 19,175 | 11,710 |
Total current accrued expenses | $ 53,932 | $ 42,412 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2021 | Jan. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee Lease Description [Line Items] | |||||
Right-of-use asset | $ 66,069 | $ 70,720 | |||
Lessee, operating lease, option to extend | These leases have terms varying from one to approximately sixteen years, with renewal options of up to ten years | ||||
Letters of credit outstanding amount | $ 15,200 | 15,200 | $ 15,200 | ||
Future minimum payments under the operating leases | $ 177,702 | ||||
Remaining weighted-average lease term | 11 years 6 months | ||||
Operating lease liabilities, weighted-average discount rate | 8.28% | ||||
Total short-term lease expense | $ 0 | $ 0 | $ 1,200 | ||
The Premises 2020 Lease Agreement | |||||
Lessee Lease Description [Line Items] | |||||
Right-of-use asset | $ 6,000 | ||||
Lessee, operating lease, option to extend | The Company has no option to extend the lease, and no option to early terminate the lease. | The Company has the option to extend the lease for two successive five-year periods. The Company also has a one-time option to terminate the lease after 10 years from the Rent Commencement Date | |||
Lessee, operating lease, existence of option to extend | true | ||||
Lease term | 6 years | 15 years | |||
Option to terminate lease | 10 years | ||||
Early termination fees | $ 30,000 | ||||
Letters of credit outstanding amount | 15,000 | ||||
Minimum | |||||
Lessee Lease Description [Line Items] | |||||
Future minimum payments under the operating leases | $ 177,700 | ||||
Maximum | |||||
Lessee Lease Description [Line Items] | |||||
Lease term | 16 years | ||||
Maximum | The Premises 2020 Lease Agreement | |||||
Lessee Lease Description [Line Items] | |||||
Renewal term | 10 years | ||||
Aggregate tenant improvements of the premises | $ 29,800 |
Leases (Details 1)
Leases (Details 1) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lease, Cost [Abstract] | |||
Straight-line lease expense | $ 15,010 | $ 15,354 | $ 12,076 |
Variable lease expense | 2,614 | 1,660 | 2,245 |
Total operating lease expense | $ 17,624 | $ 17,014 | $ 14,321 |
Leases (Details 2)
Leases (Details 2) $ in Thousands | Dec. 31, 2022 USD ($) |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | |
2023 | $ 14,597 |
2024 | 14,836 |
2025 | 15,087 |
2026 | 15,540 |
2027 | 16,006 |
Thereafter | 101,636 |
Total undiscounted lease payments | 177,702 |
Less: imputed interest | (68,364) |
Total lease liability | $ 109,338 |
Convertible Preferred Stock a_3
Convertible Preferred Stock and Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||||
Jun. 09, 2022 | Sep. 13, 2013 | Jan. 31, 2021 | Nov. 30, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2020 | Jan. 31, 2019 | May 02, 2017 | May 10, 2016 | |
Convertible preferred stock | ||||||||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||||
Dividends declared | $ 0 | |||||||||||
Shares reserved for issuance | 38,846,873 | 30,631,786 | ||||||||||
Stock purchases under the plan (in shares) | 0 | |||||||||||
Performance stock, granted | 1,199,377 | |||||||||||
Issuance of common stock from equity incentive plans, net of issuance costs | $ 9,207 | $ 20,714 | $ 9,655 | |||||||||
Pre-Funded Warrants | ||||||||||||
Convertible preferred stock | ||||||||||||
Number of shares to be purchased | 257,310 | 257,310 | ||||||||||
Purchase price of prefunded warrants | $ 85.499 | |||||||||||
Exercise price of warrants | $ 0.001 | |||||||||||
Terms of exercise | The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise the Pre-Funded 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 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. | |||||||||||
Maximum percentage of common stock ownership together with affiliates allowable after exercise of prefunded warrants | 9.99% | |||||||||||
Maximum percentage of common stock ownership after change upon notice. | 19.99% | |||||||||||
Employee and Non Employee Stock Option | ||||||||||||
Convertible preferred stock | ||||||||||||
Total intrinsic value of stock options exercised | $ 23,800 | $ 184,300 | $ 59,700 | |||||||||
Issuance of common stock from equity incentive plans, net of issuance costs | $ 9,200 | |||||||||||
Employee Stock Purchase Plan | ||||||||||||
Convertible preferred stock | ||||||||||||
Shares reserved for issuance | 729,000 | 729,000 | 729,000 | |||||||||
Additional shares authorized (as a percent) | 2% | |||||||||||
Additional shares authorized | 450,000 | |||||||||||
Restricted Stock Units (RSUs) | ||||||||||||
Convertible preferred stock | ||||||||||||
Shares reserved for issuance | 5,862,733 | 4,008,832 | ||||||||||
Expected recognition period of unrecognized compensation cost | 2 years 9 months 18 days | 3 years 2 months 12 days | 2 years 10 months 24 days | |||||||||
Performance stock, granted | 3,211,208 | |||||||||||
Unrecognized compensation cost related to unvested restricted shares | $ 137,700 | $ 98,200 | $ 20,800 | |||||||||
Performance-based restricted granted, none of vested Units Outstanding | 1,797,619 | 1,199,377 | ||||||||||
Common Stock | ||||||||||||
Convertible preferred stock | ||||||||||||
Common stock issued | 5,122,807 | 7,108,796 | ||||||||||
Conversion of preferred shares to common stock | 125,000 | |||||||||||
Non-Voting Class A Preferred Stock | Maximum | ||||||||||||
Convertible preferred stock | ||||||||||||
Number of shares to be issued upon conversion | 14,097,745 | |||||||||||
Non-Voting Class A Preferred Stock | Redmile Group, LLC and Affiliates | ||||||||||||
Convertible preferred stock | ||||||||||||
Percentage of common stock ownership upon preferred stock conversion | 19.99% | |||||||||||
Terms of conversion | The Class A Preferred were purchased exclusively by entities affiliated with Redmile Group, LLC (collectively, Redmile). The terms of the CoD prohibited Redmile from converting the Class A Preferred into shares of the Company’s common stock if, as a result of conversion, Redmile, together with its affiliates, would own more than 9.99% of the Company’s common stock then issued and outstanding (the Redmile Percentage Limitation), which percentage could change at Redmile’s election upon 61 days’ notice to the Company to (i) any other number less than or equal to 19.99% or (ii) subject to approval of the Company’s stockholders to the extent required in accordance with the NASDAQ Global Market rules, any number in excess of 19.99%. On May 2, 2017, the Company’s stockholders approved the issuance of up to an aggregate of 14,097,745 shares of common stock upon the conversion of the outstanding shares of Class A Preferred. As a result, Redmile has the right to increase the Redmile Percentage Limitation to any percentage in excess of 19.99% at its election. | |||||||||||
Non-Voting Class A Preferred Stock | Redmile Group, LLC and Affiliates | Maximum | ||||||||||||
Convertible preferred stock | ||||||||||||
Percentage of common stock ownership upon preferred stock conversion | 9.99% | |||||||||||
Preferred shares converted into common stock percentage of ownership change upon notice | 19.99% | |||||||||||
Class A Convertible Preferred Shares | ||||||||||||
Convertible preferred stock | ||||||||||||
Preferred stock, issued shares | 2,794,549 | 2,794,549 | ||||||||||
Conversion of preferred shares to common stock | 25,000 | |||||||||||
Class A Convertible Preferred Shares | Redmile Group, LLC and Affiliates | ||||||||||||
Convertible preferred stock | ||||||||||||
Percentage of common stock ownership upon preferred stock conversion | 19.99% | |||||||||||
Stock Option And Incentive Plan 2013 | ||||||||||||
Convertible preferred stock | ||||||||||||
Shares reserved for issuance | 0 | 3,356,946 | ||||||||||
Stock Option And Incentive Plan 2013 | Employee and Non Employee Stock Option | ||||||||||||
Convertible preferred stock | ||||||||||||
Stock options generally vested on anniversary grant date (as a percent) | 25% | |||||||||||
General vesting period after first year | 3 years | |||||||||||
Monthly vesting period | 4 years | |||||||||||
Term of stock awards | 10 years | |||||||||||
Weighted-average grant date fair value per share of employee options granted | $ 24.07 | $ 55.83 | $ 18.87 | |||||||||
Unrecognized compensation cost related to outstanding options | $ 35,100 | $ 48,900 | $ 66,100 | |||||||||
Expected recognition period of unrecognized compensation cost | 2 years 2 months 12 days | 2 years 3 months 18 days | 2 years 10 months 24 days | |||||||||
Stock Option And Incentive Plan 2013 | Restricted Stock Units (RSUs) | ||||||||||||
Convertible preferred stock | ||||||||||||
Annually vesting period | 4 years | |||||||||||
Stock Option And Incentive Plan2022 [Member] | ||||||||||||
Convertible preferred stock | ||||||||||||
Common stock issued | 9,500,000 | |||||||||||
Shares reserved for issuance | 10,274,169 | 0 | ||||||||||
Stock Option And Incentive Plan2022 [Member] | Employee and Non Employee Stock Option | ||||||||||||
Convertible preferred stock | ||||||||||||
Stock options generally vested on anniversary grant date (as a percent) | 25% | |||||||||||
General vesting period after first year | 3 years | |||||||||||
Monthly vesting period | 4 years | |||||||||||
Term of stock awards | 10 years | |||||||||||
Stock Option And Incentive Plan2022 [Member] | Restricted Stock Units (RSUs) | ||||||||||||
Convertible preferred stock | ||||||||||||
Annually vesting period | 4 years | |||||||||||
Inducement Plan | ||||||||||||
Convertible preferred stock | ||||||||||||
Shares reserved for issuance | 741,000 | 856,000 | 500,000 | |||||||||
Additional shares reserved for issuance | 300,000 | 470,822 | 200,000 | |||||||||
November 2016 Placement | Common Stock | ||||||||||||
Convertible preferred stock | ||||||||||||
Common stock issued | 7,236,837 | |||||||||||
Share issue price (in dollars per share) | $ 2.66 | |||||||||||
November 2016 Placement | Non-Voting Class A Preferred Stock | ||||||||||||
Convertible preferred stock | ||||||||||||
Preferred stock, issued shares | 2,819,549 | |||||||||||
Share issue price (in dollars per share) | $ 13.30 | |||||||||||
Number of shares to be issued upon conversion | 5 | |||||||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | |||||||||||
Conversion price | $ 2.66 |
Convertible Preferred Stock a_4
Convertible Preferred Stock and Stockholders' Equity (Details 2) - Employee and Non Employee Stock Option $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Number of Options | |
Balance at the beginning of the period | shares | 7,708,263 |
Granted | shares | 848,457 |
Exercised | shares | (941,780) |
Cancelled | shares | (347,714) |
Balance at the end of the period | shares | 7,267,226 |
Vested and expected to vest at the end of the period | shares | 7,267,226 |
Exercisable at the end of the period | shares | 5,722,035 |
Weighted-Average Price | |
Balance at the beginning of the period | $ / shares | $ 20.43 |
Granted | $ / shares | 36.68 |
Exercised | $ / shares | 9.74 |
Cancelled | $ / shares | 48.56 |
Balance at the end of the period | $ / shares | 22.37 |
Vested and expected to vest at the end of the period | $ / shares | 22.37 |
Exercisable at the end of the period | $ / shares | $ 18.20 |
Weighted Average Remaining Contractual Term | |
Outstanding at the end of the period | 6 years 3 months 18 days |
Vested and expected to vest at the end of the period | 6 years 3 months 18 days |
Exercisable at the end of the period | 5 years 9 months 14 days |
Aggregate Intrinsic Value | |
Outstanding at the end of the period | $ | $ 7,577 |
Vested and expected to vest at the end of the period | $ | 7,577 |
Exercisable at the end of the period | $ | $ 7,577 |
Convertible Preferred Stock a_5
Convertible Preferred Stock and Stockholders' Equity (Details 3) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Restricted Stock Units | ||
Granted | 1,199,377 | |
Restricted Stock Units (RSUs) | ||
Number of Restricted Stock Units | ||
Balance at the beginning of the period | 4,008,832 | |
Granted | 3,211,208 | |
Vested | (626,175) | |
Cancelled | (731,132) | |
Balance at the end of the period | 5,862,733 | 4,008,832 |
Expected to vest at the end of the period | 4,065,114 | |
Weighted-Average Grant Date Fair Value per Share | ||
Balance at the beginning of the period | $ 58.60 | |
Granted | 36.58 | |
Vested | 53.44 | |
Cancelled | 51.46 | |
Balance at the end of the period | 48.13 | $ 58.60 |
Expected to vest at the end of the period | $ 44.46 | |
Weighted Average Remaining Vesting Period | ||
Outstanding at the end of the period | 3 years 1 month 17 days | |
Expected to vest at the end of the period | 2 years 9 months | |
Aggregate Intrinsic Value | ||
Outstanding at the end of the period (in dollars) | $ 59,155 | |
Restricted stock units expected to vest at December 31, 2021 | $ 41,017 |
Convertible Preferred Stock a_6
Convertible Preferred Stock and Stockholders' Equity (Details 4) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Convertible preferred stock | |||
Total stock-based compensation expense | $ 78,733 | $ 54,364 | $ 30,753 |
Research And Development | |||
Convertible preferred stock | |||
Total stock-based compensation expense | 51,103 | 35,140 | 18,636 |
General And Administrative | |||
Convertible preferred stock | |||
Total stock-based compensation expense | $ 27,630 | $ 19,224 | $ 12,117 |
Convertible Preferred Stock a_7
Convertible Preferred Stock and Stockholders' Equity (Details 5) - Employee and Non Employee Stock Option | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Weighted-average assumptions to determine fair value of stock options | |||
Risk–free interest rate | 1.90% | 0.50% | 1% |
Expected volatility | 76.20% | 76.50% | 77.50% |
Expected term (in years) | 5 years 9 months 18 days | 5 years 1 month 6 days | 5 years 6 months |
Expected dividend yield | 0% | 0% | 0% |
Convertible Preferred Stock a_8
Convertible Preferred Stock and Stockholders' Equity (Details 6) - shares | Dec. 31, 2022 | Dec. 31, 2021 | May 10, 2016 | Sep. 13, 2013 |
Weighted-average assumptions to determine fair value of stock options | ||||
Shares reserved for issuance | 38,846,873 | 30,631,786 | ||
Stock Option And Incentive Plan 2013 | ||||
Weighted-average assumptions to determine fair value of stock options | ||||
Shares reserved for issuance | 0 | 3,356,946 | ||
Awards available under the 2022 Plan | ||||
Weighted-average assumptions to determine fair value of stock options | ||||
Shares reserved for issuance | 10,274,169 | 0 | ||
Inducement Plan | ||||
Weighted-average assumptions to determine fair value of stock options | ||||
Shares reserved for issuance | 741,000 | 856,000 | 500,000 | |
Employee Stock Option | ||||
Weighted-average assumptions to determine fair value of stock options | ||||
Shares reserved for issuance | 7,267,226 | 7,708,263 | ||
Restricted Stock Units (RSUs) | ||||
Weighted-average assumptions to determine fair value of stock options | ||||
Shares reserved for issuance | 5,862,733 | 4,008,832 | ||
Employee Stock Purchase Plan | ||||
Weighted-average assumptions to determine fair value of stock options | ||||
Shares reserved for issuance | 729,000 | 729,000 | 729,000 | |
Convertible Preferred Stock (if converted) | ||||
Weighted-average assumptions to determine fair value of stock options | ||||
Shares reserved for issuance | 13,972,745 | 13,972,745 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of the Company's expected federal income tax provision (benefit) to the actual income tax provision | |||
Tax computed at federal statutory rate | $ (59,161) | $ (44,551) | $ (36,411) |
State tax, net of federal tax benefit | (11,109) | (6,966) | (1,296) |
Non-deductible compensation | 2,086 | 10,202 | 75 |
Permanent differences | (1,340) | (686) | 240 |
Stock compensation | 3,356 | (35,852) | 6,073 |
R&D tax credits | (14,484) | (12,140) | (7,177) |
Reserve for uncertain tax positions | 12,564 | 7,192 | 1,555 |
Other | (1,376) | 84 | 70 |
Valuation allowance | 69,464 | 82,717 | 49,497 |
Income tax expense | 0 | 0 | $ 0 |
Deferred tax assets: | |||
Capitalized R&D expense | 127,250 | 95,172 | |
Net operating losses | 84,608 | 62,913 | |
R&D tax credits | 49,736 | 35,387 | |
Intangible asset amortization | 8,012 | 6,985 | |
Deferred revenue | 8,714 | 8,706 | |
Stock compensation | 13,128 | 8,710 | |
Lease liability | 22,961 | 24,112 | |
Other | 2,526 | 6,972 | |
Total deferred tax assets | 316,935 | 248,957 | |
Deferred tax liabilities: | |||
Depreciation | (6,814) | (7,323) | |
Right-of-use assets | (13,874) | (14,851) | |
Total deferred tax liabilities | (20,688) | (22,174) | |
Net of deferred tax assets and liabilities | 296,247 | 226,783 | |
Valuation allowance | (296,247) | (226,783) | |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Details 2)
Income Taxes (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Valuation allowance | $ 296,247,000 | $ 226,783,000 |
U.S. Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 392,500 | |
Net operating loss carryforward expiration year | 2027 | |
California | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 452,200 | |
Net operating loss carryforward expiration year | 2028 |
Income Taxes (Details 3)
Income Taxes (Details 3) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Tax Credit Carryforward [Line Items] | |
Cumulative changes in ownership percentage | 50% |
Period of change in ownership | 3 years |
Californian | |
Tax Credit Carryforward [Line Items] | |
Income tax examination, year under examination | 2018 |
U.S. Federal | |
Tax Credit Carryforward [Line Items] | |
Income tax examination, year under examination | 2019 |
U.S. Federal | Research and development | |
Tax Credit Carryforward [Line Items] | |
Tax credit carryforwards | $ 35.1 |
Tax credit carryforward expiration year | 2035 |
California | Research and development | |
Tax Credit Carryforward [Line Items] | |
Tax credit carryforwards | $ 33.3 |
Income Taxes (Details 4)
Income Taxes (Details 4) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Change in the Company's unrecognized tax benefits | |||
Beginning unrecognized tax benefits | $ 37,255,000 | $ 19,779,000 | $ 16,822,000 |
Increase related to current year tax positions | 9,101,000 | 17,557,000 | 1,837,000 |
Increase related to prior year tax positions | 6,411,000 | 0 | 1,120,000 |
Decrease related to prior year tax positions | 0 | (81,000) | 0 |
Ending unrecognized tax benefits | 52,767,000 | $ 37,255,000 | $ 19,779,000 |
Income Taxes | |||
Unrecognized tax benefit | 0 | ||
Unrecognized tax benefits that, if recognized, would reduce the effective tax rate | $ 0 |
Employee Benefits (Details)
Employee Benefits (Details) - USD ($) | 12 Months Ended | |
Jan. 01, 2009 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Minimum age of employees | 21 years | |
Matching contributions under 401(k) plan | $ 0 | |
Percentage of discretionary contributions description | The Company makes discretionary contributions to the 401(k) Plan equal to 100 percent of each employee’s pretax contributions up to 20 percent of the IRS Standard Limit. |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Minimum annual payments to maintain licenses | $ 0.4 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event - Corporate Restructuring $ in Millions | 1 Months Ended |
Jan. 31, 2023 USD ($) Employees | |
Debt Instrument [Line Items] | |
Percentage of number of employee reduced | 60% |
Number of employee reduced | Employees | 220 |
Severance and employee termination related costs - Low range | $ 12 |
Severance and employee termination related costs - High range | $ 16 |