Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 29, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-40215 | ||
Entity Registrant Name | Instil Bio, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 83-2072195 | ||
Entity Address, Address Line One | 3963 Maple Avenue, Suite 350 | ||
Entity Address, City or Town | Dallas | ||
Entity Address, State or Province | TX | ||
Entity Address, Postal Zip Code | 75219 | ||
City Area Code | 972 | ||
Local Phone Number | 499-3350 | ||
Title of 12(b) Security | Common Stock, $0.000001 par value per share | ||
Trading Symbol | TIL | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 285.7 | ||
Entity Common Stock, Shares Outstanding | 130,079,097 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission (SEC) subsequent to the date hereof 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. Such proxy statement will be filed with the SEC not later than 120 days after the conclusion of the registrant's fiscal year ended December 31, 2022. | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001789769 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Firm ID | 34 |
Auditor Name | Deloitte & Touche LLP |
Auditor Location | San Diego, California |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 43,716 | $ 37,590 |
Marketable securities | 217,204 | 416,509 |
Prepaid expenses and other current assets | 8,458 | 9,921 |
Total current assets | 269,378 | 464,020 |
Property, plant and equipment, net | 196,880 | 121,999 |
Operating lease right-of-use assets | 12,457 | 0 |
Intangible assets | 0 | 10,104 |
Goodwill | 0 | 5,722 |
Other long-term assets | 3,413 | 8,138 |
Total assets | 482,128 | 609,983 |
Current liabilities: | ||
Accounts payable | 2,359 | 5,568 |
Accrued expenses and other current liabilities | 30,069 | 34,449 |
Contingent consideration, current portion | 360 | 1,341 |
Total current liabilities | 32,788 | 41,358 |
Contingent consideration, net of current portion | 7,882 | 10,980 |
Operating lease liabilities, non-current | 5,171 | 0 |
Deferred tax liabilities | 0 | 2,426 |
Other long-term liabilities | 332 | 20 |
Loan payable | 72,350 | 0 |
Total liabilities | 118,523 | 54,784 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, par value $0.000001 per share; 10,000,000 shares authorized; zero shares issued and outstanding as of December 31, 2022, and 2021 | 0 | 0 |
Common stock, par value $0.000001 per share; 300,000,000 shares authorized; 130,079,097 and 129,028,278 shares issued and outstanding as of December 31, 2022, and 2021, respectively | 0 | 0 |
Additional paid-in capital | 788,992 | 757,003 |
Accumulated other comprehensive loss | (493) | (87) |
Accumulated deficit | (424,894) | (201,717) |
Total stockholders’ equity | 363,605 | 555,199 |
Total liabilities and stockholders’ equity | $ 482,128 | $ 609,983 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.000001 | $ 0.000001 |
Common stock, shares issued (in shares) | 130,079,097 | 129,028,278 |
Common stock, shares outstanding (in shares) | 130,079,097 | 129,028,278 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 141,056 | $ 107,251 |
General and administrative | 62,235 | 48,309 |
Total restructuring and impairment charges | 23,167 | 0 |
Total operating expenses | 226,458 | 155,560 |
Loss from operations | (226,458) | (155,560) |
Interest income | 3,655 | 80 |
Interest expense | (1,883) | 0 |
Other expense, net | (564) | (1,275) |
Loss before income tax expense | (225,250) | (156,755) |
Income tax benefit (expense) | 2,073 | (39) |
Net loss | (223,177) | (156,794) |
Other comprehensive income (loss): | ||
Foreign currency translation | 9 | 246 |
Unrealized loss on available-for-sale securities, net | (415) | (50) |
Net comprehensive loss | $ (223,583) | $ (156,598) |
Net loss per share, basic (in dollars per share) | $ (1.72) | $ (1.48) |
Net loss per share, diluted (in dollars per share) | $ (1.72) | $ (1.48) |
Weighted-average shares used in computing net loss per share, basic (in shares) | 129,512,610 | 105,993,230 |
Weighted-average shares used in computing net loss per share, diluted (in shares) | 129,512,610 | 105,993,230 |
Restructuring liability balance | $ 5,434 | $ 0 |
CONSOLIDATED STATEMENTS OF CONV
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 70,176,046 | ||||
Beginning balance at Dec. 31, 2020 | $ 331,966 | ||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Issuance of convertible preferred shares (in shares) | 4,174,551 | ||||
Issuance of convertible preferred shares | $ 52,460 | ||||
Conversion of redeemable convertible preferred stock (in shares) | (74,350,597) | ||||
Conversion of redeemable convertible preferred stock | $ (384,426) | ||||
Ending balance (in shares) at Dec. 31, 2021 | 0 | ||||
Ending balance at Dec. 31, 2021 | $ 0 | ||||
Beginning balance (in shares) at Dec. 31, 2020 | 20,591,554 | ||||
Beginning balance at Dec. 31, 2020 | (39,599) | $ 0 | $ 5,607 | $ (283) | $ (44,923) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common shares upon initial public offering net of underwriting discounts, commissions and offering costs (in shares) | 18,400,000 | ||||
Issuance of common shares upon initial public offering net of underwriting discounts, commissions and offering costs | 339,016 | 339,016 | |||
Conversion of redeemable convertible preferred stock (in shares) | 89,220,699 | ||||
Conversion of redeemable convertible preferred stock | $ 384,426 | 384,426 | |||
Issuance of common stock from exercises of stock options (in shares) | 3,976,028 | 816,025 | |||
Issuance of common stock from exercises of stock options | $ 1,757 | 1,757 | |||
Stock-based compensation | 26,197 | 26,197 | |||
Net loss | (156,794) | (156,794) | |||
Other comprehensive income (loss) | 196 | 196 | |||
Ending balance (in shares) at Dec. 31, 2021 | 129,028,278 | ||||
Ending balance at Dec. 31, 2021 | 555,199 | $ 0 | 757,003 | (87) | (201,717) |
Ending balance at Dec. 31, 2022 | $ 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock from exercises of stock options (in shares) | 1,050,819 | ||||
Shares of common stock issued in connection with incentive stock plan (in shares) | 1,050,819 | ||||
Shares of common stock issued in connection with incentive stock plan | $ 1,548 | 1,548 | |||
Stock-based compensation | 30,441 | 30,441 | |||
Net loss | (223,177) | (223,177) | |||
Other comprehensive income (loss) | (406) | (406) | |||
Ending balance (in shares) at Dec. 31, 2022 | 130,079,097 | ||||
Ending balance at Dec. 31, 2022 | $ 363,605 | $ 0 | $ 788,992 | $ (493) | $ (424,894) |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (Parenthetical) | Dec. 31, 2021 $ / shares |
Series C | |
Shares issued, price per share (in dollars per share) | $ 12.58 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (223,177) | $ (156,794) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 30,441 | 26,197 |
Non-cash lease expense | 1,765 | 0 |
Foreign exchange remeasurement loss | 1,391 | 710 |
Goodwill, Impairment Loss | 15,826 | 0 |
Impairment of goodwill and intangible assets | 1,907 | 0 |
Change in fair value of contingent consideration | (2,879) | 294 |
Depreciation and amortization | 5,987 | 2,752 |
Non-cash interest expense | (1,225) | 0 |
Change in fair value of derivative instrument | (1,414) | 0 |
Other, net | 780 | 342 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (430) | (5,045) |
Other long-term assets | 354 | (6,502) |
Accounts payable | (1,806) | 3,862 |
Operating lease liabilities | (335) | 0 |
Long-term liabilities | 1,628 | 0 |
Accrued expenses and other current liabilities | (8,977) | 12,046 |
Net cash used in operating activities | (180,164) | (122,138) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (665,046) | (1,107,565) |
Maturities of marketable securities | 865,350 | 691,000 |
Purchases of property, plant and equipment | (84,589) | (57,831) |
Purchase of derivative financial instrument | (1,174) | 0 |
Net cash provided by (used in) investing activities | 114,541 | (474,396) |
Cash flows from financing activities: | ||
Proceeds from initial public offering, net of issuance costs | 0 | 339,016 |
Proceeds from issuance of convertible preferred stock, net of issuance costs | 0 | 52,460 |
Proceeds from exercise of stock options | 1,548 | 1,757 |
Proceeds from note payable | 70,338 | 0 |
Other financing activities | 0 | (69) |
Net cash provided by financing activities | 71,886 | 393,164 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 6,263 | (203,370) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (637) | (304) |
Cash, cash equivalents and restricted cash—beginning of period | 38,090 | 241,764 |
Cash, cash equivalents and restricted cash—end of period | 43,716 | 38,090 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest, net of amounts capitalized | 1,068 | 0 |
Supplemental disclosure of noncash information: | ||
Conversion of preferred stock to common stock upon IPO | 0 | 384,426 |
Purchases of property, plant and equipment in accounts payable and accrued expenses and other current liabilities | $ 12,433 | $ 15,091 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of BusinessInstil Bio, Inc. (the “Company” or “Instil Bio”) is headquartered in Dallas, Texas and was incorporated in the state of Delaware in August 2018. The Company is a clinical-stage biopharmaceutical company focused on developing an innovative cell therapy pipeline of autologous tumor infiltrating lymphocyte (“TIL”) therapies for the treatment of patients with cancer. Principal operations commenced during the first quarter of 2019 when the Company in-licensed its foundational TIL technology. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company and its wholly owned subsidiaries. Instil Bio (UK) Ltd. (formerly Immetacyte Ltd. (“Immetacyte”)) and Complex Therapeutics, LLC. Immetacyte was acquired on March 2, 2020 and Complex Therapeutics, LLC was incorporated on October 14, 2020. All intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not limited to the fair value of stock valuations prior to the Company's initial public offering, the fair value of contingent consideration payable and the estimation of fair value of goodwill and in-process research and development (IPR&D) intangible assets and associated impairment charges. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. Concentration of Credit Risk Financial Instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities. The Company's cash and cash equivalents are held by two financial institutions in the United States ("U.S.") and one financial institution in the United Kingdom ("UK"), which management believes to be financially sound, and accordingly, minimal credit risk exists with respect to the financial institutions. At times, the Company's deposits held in the U.S. and UK may exceed the Federal Depository Insurance Corporation and Financial Services Compensation Scheme, respectively, insured limits. During the years ended December 31, 2022 and 2021, the Company has not experienced any credit losses in such accounts or marketable securities. Risks and Uncertainties The Company is subject to a number of risks similar to other development-stage biopharmaceutical companies, including but not limited to, dependency on the clinical and commercial success of its product candidates, ability to obtain regulatory approval of its product candidates, uncertainty of broad adoption of its approved products, if any, by physicians and patients, manufacturing, the need to obtain adequate additional funding, significant competition, and protection of its intellectual property portfolio. Stock Split and Initial Public Offering On March 12, 2021, the Company effected a 1.2-for-1 stock split of the Company’s common stock. The par value was not adjusted as a result of the stock split. The authorized shares as of March 12, 2021 were adjusted as a result of the stock split. All share and per share information included in the accompanying consolidated financial statements has been adjusted to reflect this stock split. The accompanying consolidated financial statements and notes thereto give retroactive effect to the stock split for all periods presented. On March 23, 2021, the Company completed its initial public offering ("IPO") through an underwritten sale of an aggregate of 18,400,000 shares of its common stock at a price of $20.00 per share. The aggregate net proceeds from the offering, inclusive of an additional 2,400,000 common shares sold upon the full exercise of the underwriter's purchase option, after deducting underwriting discounts and commissions of $25.8 million and other offering expenses of $3.2 million, was $339.0 million. Concurrent with the IPO, all then-outstanding shares of the Company's convertible preferred stock outstanding (see Note 8) were automatically converted into an aggregate of 89,220,699 shares of common stock and were reclassified into permanent equity. Further, immediately following the closing of the IPO, the Company amended and restated its certificate of incorporation such that the total number of shares of common stock authorized to be issued was 300,000,000 and the total number of shares of preferred stock authorized to be issued was 10,000,000. Following the IPO, there are no shares of convertible preferred stock outstanding. Segments Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the chief operating decision-maker in deciding how to allocate resources to an individual segment and in assessing performance. The Company has determined it operates in a single operating segment and has one operating segment. Cash, Cash Equivalents, Restricted Cash and Marketable Securities The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents include amounts invested in money market accounts. Restricted cash consists of a money market account which serves as collateral for the Company’s employee corporate credit cards and is classified within other long-term assets on the consolidated balance sheet as of December 31, 2021. The Company did not have restricted cash on the consolidated balance sheet as of December 31, 2022. The Company's short-term marketable securities have original maturities of less than a year at date of purchase. The Company classifies and accounts for marketable securities as available-for-sale securities, which are carried at their fair values based on the quoted market prices of the securities. Unrealized gains and losses are reported as accumulated other comprehensive income (loss). Realized gains on available-for-sale securities are included in net loss in the period earned or incurred. As of December 31, 2022, marketable securities consisted of U.S. Treasury bills that the Company classifies within marketable securities on the consolidated balance sheets. Short-term marketable securities are recorded at their estimated fair value. The Company periodically reviews whether its securities may be other-than-temporarily impaired, including whether or not (i) the Company has the intent to sell the security or (ii) it is more likely than not that the Company will be required to sell the security before its anticipated recovery. If one of these factors is met, the Company will record an impairment loss associated with its impaired investment. The impairment loss will be recorded as a write-down of investments in the consolidated balance sheets and a realized loss within other expense in the consolidated statements of operations and comprehensive loss. For the year ended December 31, 2022, there were no impairment losses for the investments. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the amounts shown in the consolidated statements of cash flows (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 43,716 $ 37,590 Restricted cash — 500 Cash, cash equivalents and restricted cash $ 43,716 $ 38,090 Fair Value Measurement Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company measures fair value based on a three-tier hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1 — Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2 — Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liabilities. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. In determining fair value, the Company utilize quoted market prices, or valuation techniques that maximize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value. Property, Plant and Equipment, Net Property, plant and equipment, with the exception of land, is stated at cost less accumulated depreciation. Depreciation is computed on a straight-line basis over the estimated useful lives of the related assets. Maintenance and repairs are charged to operations as incurred. Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the balance sheets and the resulting gain or loss is reflected in the consolidated statement of operations and comprehensive loss. The estimated useful lives of the Company’s property, plant and equipment are as follows: Laboratory equipment 5 years Manufacturing equipment 5 years Office and computer equipment 3 years Building 35 years Leasehold improvements Shorter of remaining lease term or estimated useful life The Company owns land and buildings that it is in the process of developing for its U.S. operations. As described in Note 3, the clinical manufacturing building has been completed and is ready for its intended use. The commercial building is still in development and depreciation will commence once the commercial manufacturing facility is ready for its intended use. A variety of costs are incurred in the development of a property. After determination is made to capitalize a cost, it is allocated to the specific component of a project that is benefited. Determination of when the development project is substantially complete and placed into service to begin depreciation involves a degree of judgment. The costs of land and buildings under development include specifically identifiable costs. The capitalized costs include pre-construction costs essential to the development of the property, development costs, and construction costs. When the development project is substantially complete and available for occupancy, the Company ceases capitalization of costs other than costs to improve the functionality or extend the useful lives of property, plant and equipment included as part of the project. Impairment of Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable or that the useful life is shorter than originally estimated. Recoverability of assets is measured by comparing the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset over its remaining useful life. If such assets are impaired, the impairment recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. If the useful life is shorter than originally estimated, the Company depreciates or amortizes the remaining carrying value over the revised shorter useful life. Assets to be disposed of by sale are reflected at the lower of their carrying amount or fair value less cost to sell. To date, the Company has recorded impairment losses on long-lived assets associated with a sustained decrease in the Company's stock price and the Plan implemented on December 2, 2022 for a strategic prioritization of the Company’s preclinical and clinical development programs. The Company recognized a non-cash impairment charge of $1.9 million during the fourth quarter of 2022. The impairment charge was recorded in the consolidated statements of operations and comprehensive loss in the line item “restructuring and impairment charges.” See Note 12 for more information. Business Combinations The Company evaluates acquisitions of assets and related liabilities and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the requirements of a business. The Company accounts for its business combinations using the acquisition method of accounting which requires recognition and measurement of all identifiable assets acquired and liabilities assumed at their full fair value as of the date it obtains control. The Company has determined the fair value of assets acquired and liabilities assumed based upon management's estimates of the fair values of assets acquired and liabilities assumed in the acquisitions. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable assets acquired. The Company accounts for contingent considerations at the acquisition-date fair value as part of the consideration transferred in the transaction and remeasures at fair value for each reporting period. While management has used its best estimates and assumptions to measure the fair value of the identifiable assets acquired and liabilities assumed at the acquisition date, these estimates are inherently uncertain and subject to refinement. As a result, during the measurement period, not to exceed one year from the date of acquisition, any changes in the estimated fair values of the net assets recorded for the acquisition will result in an adjustment to goodwill. Upon the conclusion of the measurement period of final determination of the values of assets acquired or liabilities assumed, whichever comes first, the Company records any subsequent adjustments to the consolidated statements of operations and comprehensive loss. Acquisition-related costs, such as legal and consulting fees, are expensed as incurred. The Company accounts for an asset acquisition by recognizing net assets based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. Goodwill is not recognized in an asset acquisition; any excess consideration transferred over the fair value of the net assets acquired is allocated to the non-monetary identifiable assets and liabilities assumed based on relative fair values. Acquired IPR&D is expensed as incurred provided there is no alternative future use. Goodwill and other Indefinite Lived Intangible Assets Indefinite-lived intangible assets consist of goodwill and IPR&D acquired in a business combination. Goodwill represents the excess of the purchase price over the fair value of the net tangible and intangible assets acquired in a business combination. Goodwill is not amortized but is tested for impairment at least annually or more frequently if a triggering event occurs . The Company’s impairment tests are based on a single operating segment and reporting unit structure. If the carrying value of the reporting unit exceeds its fair value, an impairment charge is recognized for the excess of the carrying value of the reporting unit over its fair value (see Note 12). IPR&D assets represent the fair value of incomplete research and development projects that had not reached technological feasibility as of the date of acquisition; initially, these are classified as IPR&D and are not subject to amortization. Once these research and development projects are completed, the asset balances are transferred from IPR&D to acquisition-related developed technology and are subject to amortization from this point forward. The Company reviews IPR&D for possible impairment annually or more frequently if events or changes in circumstances indicate that carrying amount may not be recoverable. Significant assumptions inherent in the evaluation and measurement of impairment include, but are not limited to, external factors such as industry and economic trends, and internal factors such as changes in the Company’s business strategy and the Company’s forecasts for specific projects (see Note 12). During the year ended December 31, 2022, there was $15.8 million in impairment of Goodwill & IPR&D recognized in the consolidated statement of operations and comprehensive loss in the line item "restructuring and impairment charges". Grant Proceeds The Company receives government grants in the UK for the furtherance of certain research and development projects. Grant proceeds are recognized when all conditions of such grants are fulfilled or there is a reasonable assurance that they will be fulfilled. Grant proceeds are classified as a reduction of research and development expenses. For the years ended December 31, 2022 and 2021, $1.6 million and $1.7 million, of grant proceeds were recognized in research and development expenses on the Company’s consolidated statements of operations and comprehensive loss, respectively. Research and Development Expenses Research and development (“R&D”) costs are expensed as incurred. Advance payments for research and development activities are deferred as prepaid expenses, classified as current or noncurrent on the Company’s consolidated balance sheets based on the estimated timing the related services will be performed and are expensed as the related services are performed. Costs incurred by third parties pursuant to contracts with research institutions and clinical research organizations are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from the external service providers. The Company adjusts its accrual as actual costs become known. If the actual timing of the performance of services or the level of effort varies significantly from the estimate, the Company will adjust the accrual accordingly. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception. Research and development expenses are presented net of government grants, as described above, and R&D tax and expenditure credits from the UK government, which are recognized over the period necessary to match the reimbursement with the related costs when it is probable that the Company has complied with any conditions attached and will receive the reimbursement. Reimbursable R&D tax and expenditure credits were $3.1 million and $1.8 million in the years ended December 31, 2022 and 2021, respectively. Stock-Based Compensation The Company measures its stock-based awards granted to employees, non-employee directors, consultants and independent advisors based on the estimated grant date fair value of the awards. For stock-based awards with only service conditions, compensation expense is recognized over the requisite service period using the straight-line method. For stock-based awards that include performance conditions, compensation expense is not recognized until the performance condition is probable to occur. The Company uses the Black-Scholes option pricing model to estimate the fair value of its stock-based awards. The Black-Scholes option pricing model requires the Company to make assumptions and judgements about the variables used in the calculations, including the fair value of common stock, expected term, expected volatility of the Company’s common stock, risk-free interest rate and expected dividend yield. The Company accounts for forfeitures of stock-based awards as they occur. Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts or existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period of enactment. The Company records a valuation allowance to reduce deferred tax assets to an amount expected to be realized. The Company recognizes the tax benefit from an uncertain tax position if it is more likely than not that the tax position will be sustained upon examination by the tax authorities, based on the merits of the position. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. Foreign Currency The Company’s reporting currency is the U.S. dollar. The functional currency of the Company’s subsidiary located in the United Kingdom is the British Sterling. Balance sheets prepared in the functional currency are translated to the reporting currency at exchange rates in effect at the end of the accounting period, except for stockholders’ deficit accounts, which are translated at rates in effect when these balances were originally recorded. Revenue and expense accounts are translated using an average exchange rate in effect during the period. The resulting foreign currency translation adjustments are recorded as a separate component of accumulated other comprehensive loss in the accompanying consolidated balance sheets. Gains and losses resulting from exchange rate changes on intercompany transactions denominated in a currency other than the local currency are included in earnings as incurred as the related amounts are expected to be repaid in the foreseeable future. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of the Company’s common stock outstanding for the period, without consideration for potential dilutive shares of common stock. For purposes of the diluted net loss per share calculation, convertible preferred stock and common stock options are considered to be potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for each period presented since the effects of potentially dilutive securities are antidilutive given the net loss of the Company. 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. For the year ended December 31, 2022, comprehensive loss consists of foreign currency translation adjustments, and unrealized loss on available-for-sale securities net of tax. For the year ended December 31, 2021, comprehensive loss consists of foreign currency translation adjustments and unrealized loss on available-for-sale securities. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to avail itself of this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Leases The Company adopted the new standard Accounting Standards Updated ("ASU") No. 2016-2, Leases effective January 1, 2022 using the modified retrospective transition approach. For its long-term operating leases, the Company recognizes a right-of-use asset and a lease liability on its consolidated balance sheets. The Company determines if an arrangement is or contains a lease at contract inception by assessing whether the arrangement contains an identified asset and whether the lessee has the right to control such asset. Lessees are required to classify leases as either finance or operating leases and to record a right-of-use (“ROU”) asset and a lease liability for all leases with a term greater than 12 months regardless of the lease classification. The lease classification will determine whether the lease expense is recognized based on an effective interest rate method or on a straight-line basis over the term of the lease. The Company determines the initial classification and measurement of its ROU assets and lease liabilities at the lease commencement date and thereafter if modified. For leases with a term greater than 12 months, the Company records the lease liability at the present value of lease payments over the term. The term of the Company’s leases equals the non-cancellable period of the lease, including any rent-free periods provided by the lessor, and also includes options to extend or terminate the lease that the Company is reasonably certain to exercise. The ROU asset equals the carrying amount of the related lease liability, adjusted for any lease payments made prior to lease commencement, any deferred rent upon adoption, and lease incentives provided by the lessor. The Company has elected, for all classes of underlying assets, not to recognize ROU assets and lease liabilities for leases with a term of 12 months or less. Lease cost for short-term leases is recognized on a straight-line basis over the lease term. The Company estimates its incremental borrowing rate based on the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Variable lease payments are expensed as incurred and do not factor into the measurement of the applicable ROU asset or lease liability. Lease payments may be fixed or variable; however, only fixed payments are included in the Company’s lease liability calculation. Lease costs for the Company’s operating leases are recognized on a straight-line basis within operating expenses over the lease term. The Company’s lease agreements may contain non-lease components such as common area maintenance, operating expenses or other costs, which are expensed as incurred for all classes of assets. The Company’s leases do not contain any residual value guarantees. See Note 7, Commitments and Contingencies, regarding the Company’s leases, below. Recent Accounting Pronouncements Adopted In February 2016, the Financial Accounting Standards Board ("FASB") issued ASU No. 2016-02 $12.5 million and $7.6 million , respectively, to reflect the present value of remaining lease payments under existing lease arrangements. The Company applied the modified retrospective transition approach and did not recast prior periods. As permitted by the standard, the Company elected the transition practical expedient package, which among other things, allows the carryforward of historical lease classifications. The Company’s new accounting policies around leases are described in Leases, above, and in Note 7, Commitments and Contingencies. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. Additionally, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, in April 2019 and ASU 2019-05, Financial Instruments — Credit Losses (Topic 326) — Targeted Transition Relief, in May 2019. The amendments affect loans, debt securities, trade receivables, net investments in leases, off-balance-sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. The Company adopted this standard on January 1, 2022. The adoption of this standard did not have a material impact on the Company's consolidated financial statements and disclosures. In December 2019, the FASB issued ASU No. 2019-12. Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The standard simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and also improves consistent application by clarifying and amending existing guidance. The Company adopted this standard on January 1, 2022 . The adoption of this standard did not have a material impact on the Company's consolidated financial statements and disclosures. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | Balance Sheet Components Property, Plant and Equipment, Net Property, plant and equipment, net consist of the following (in thousands): December 31, 2022 2021 Land $ 31,243 $ 31,243 Laboratory equipment 19,050 13,962 Buildings (1) 32,778 6,034 Office and computer equipment 4,969 2,239 Leasehold improvements 4,340 1,836 Manufacturing equipment 8,803 1,717 Vehicles 64 64 Construction work-in-progress 104,117 67,883 Total property, plant and equipment, gross 205,364 124,978 Less: accumulated depreciation (8,484) (2,979) Total property, plant and equipment, net $ 196,880 $ 121,999 ______________________________________________________________ (1) Relates to a building which was developed as part of the Company’s clinical manufacturing facility in Tarzana, California. The building was placed into service and ready for its intended use as of the end of the quarter ended June 30, 2022. For the years ended December 31, 2022 and 2021 the Company recognized depreciation expense of $6.0 million and $2.7 million, respectively, in the consolidated statements of operations and comprehensive loss. As of December 31, 2022 the Company is in the process of developing this land for its U.S. operations and has capitalized $104.0 million in work-in-progress costs associated with this development project. The Company’s contractual commitments for this development project are limited to unreimbursed spend by the general contractor and as such, as of December 31, 2022 and 2021, $4.0 million and $63.2 million, respectively, is contractually committed to the development of this project. During the year ended December 31, 2022, the Company capitalized $1.2 million of interest related to qualifying expenditures for construction work-in-progress for its commercial manufacturing facility, which is not ready for its intended use. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following (in thousands): December 31, 2022 2021 Accrued construction costs $ 12,359 $ 12,085 Accrued compensation and benefits 3,273 11,928 Accrued operational expenses 2,203 5,292 Accrued restructuring costs 5,434 — Accrued research, development and clinical trial expenses 3,827 4,234 Operating lease liabilities, current 2,381 — Current tax liabilities — 524 Other current liabilities 592 386 Total accrued expenses and other current liabilities $ 30,069 $ 34,449 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets In March 2020, the Company acquired 100% of the share capital of Immetacyte. The acquisition was accounted for as a business combination and, accordingly, the total fair value of purchase consideration was allocated to the tangible and intangible assets acquired and liabilities assumed based on their fair values on the acquisition date. Due to the Company’s pre-commercialization stage, many of the processes and methods used in the production of TILs were still in experimental development and pre-clinical stages and as such, resulted in a $10.1 million IPR&D asset and $5.7 million in goodwill. During December 2022, the Company realigned its preclinical and clinical development programs driven by discontinuation of its ITIL-168 development program (see Note 12). As of December 31, 2022, the Company determined that the carrying amount of its goodwill and intangible assets exceeded its fair value. The fair value was determined based on a discounted cash flow analysis, which took into account multiple factors including future cash flows, discount rates, and market conditions. As a result of this analysis, the Company recognized a non-cash impairment charge of $5.7 million for goodwill and $10.1 million for intangible assets during the fourth quarter of 2022. The impairment charge was recorded in the consolidated statements of operations and comprehensive loss in the line item “restructuring and impairment charges.” |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | Fair Value Measurement The fair value of cash and cash equivalents approximates carrying value since cash and cash equivalents consist of short-term highly liquid investments with maturities of less than three months at the time of purchase. Cash and cash equivalents are quoted market prices in active markets for identical assets and are therefore classified as Level 1 assets. Money market funds are open-end mutual funds that invest in cash, government securities, and/or repurchase agreements that are collateralized fully. To the extent that these funds are valued based upon the reported net asset value, they are categorized in Level 1 of the fair value hierarchy. Short-term marketable securities comprised of U.S. Treasury bills that are classified within Level 2 of the fair value hierarchy are valued based on other observable inputs, including broker or dealer quotations, alternative pricing sources or U.S. Government Treasury yield of appropriate term. The following tables provide information by level for assets and liabilities that are measured at fair value on a recurring basis: As of December 31, 2022 Level 1 Level 2 Level 3 Total (In thousands) Financial Assets Money market funds $ 22,830 $ — $ — $ 22,830 U.S. Treasury bills — 217,204 — 217,204 Derivative financial instrument — 2,202 — 2,202 Total $ 22,830 $ 219,406 $ — $ 242,236 Financial Liabilities Contingent consideration $ — $ — $ 8,242 $ 8,242 As of December 31, 2021 Level 1 Level 2 Level 3 Total (In thousands) Financial Assets Money market funds $ 18,493 $ — $ — $ 18,493 U.S. Treasury bills — 416,509 — 416,509 Total $ 18,493 $ 416,509 $ — $ 435,002 Financial Liabilities Contingent consideration $ — $ — $ 12,321 $ 12,321 There were no transfers in or out of Level 1, 2 and 3 measurements for the years ended December 31, 2022 and 2021. As of December 31, 2022 and 2021, there were no securities within Level 3 of the fair value hierarchy. The derivative financial instrument above relates to the interest rate swap discussed in Note 7, and is included in other long-term assets As of December 31, 2022, the fair value of the Company's Loan (as defined in Note 7) was $69.0 million. The fair value was determined on the basis of its net present value and is considered Level 2 in the fair value hierarchy (see Note 2). The following table sets forth a summary of the changes in the fair value of the Company's Level 3 financial liabilities (in thousands): Year Ended December 31, 2022 Fair value, beginning balance $ 12,321 Change in fair value (2,879) Development milestone achieved (1,200) Fair value, ending balance $ 8,242 Year Ended December 31, 2021 Fair value, beginning balance $ 12,277 Change in fair value 294 Development milestone achieved (250) Fair value, ending balance $ 12,321 The Company’s acquisition of Immetacyte involved the potential for the payment of future contingent consideration upon the achievement of (i) certain product development milestones including, approval of studies and commencement and completion of certain product trials, or (ii) various other performance conditions including, receipt of final approval for the first marketing authorization and first commercial sale in certain geographical markets. Contingent consideration is recorded at the estimated fair value of the contingent payments on the acquisition date. The fair value of the contingent consideration is remeasured at the estimated fair value at each reporting period with the change in fair value recognized as income or expense within research and development expense in the consolidated statements of operations and comprehensive loss. During the year of acquisition, Company determines the fair value of the contingent consideration by probability weighting scenarios of milestone achievements to determine the expected future contingent consideration payment, discounted to present value using an 8% discount rate based on the Company’s pre-tax cost of debt on the acquisition date. The probability of payments ranged from 20% to 100% and the timing of future payments ranged from 2020 to 2026. In determining the likelihood of milestone achievements which trigger payouts related to the contingent consideration, as well as the probabilities for various scenarios used in the Company’s calculations were based on internal unobservable projections. During the year ended December 31, 2021, the change of fair value related to the contingent consideration is due to the Company recognizing a development milestone of $0.3 million, the change in present value for the passage of time, as well as expected dates and probabilities of milestone achievement revisions. During the year ended December 31, 2021, the Company recognized a development milestone achievement, which is classified as an accrued expense in other current liabilities in the consolidated balance sheets as of December 31, 2021 and subsequently paid in 2022. During the year ended December 31, 2022, the change of fair value related to the contingent consideration is due to the Company recognizing development milestones of $1.2 million, the discontinuation of ITIL-168 development program, the change in present value for the passage of time, as well as expected dates and probabilities of milestone achievement revisions. |
Financial Instruments
Financial Instruments | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Financial Instruments | Financial Instruments Marketable securities classified as available-for-sale at December 31, 2022 and 2021 consisted of the following (in thousands): December 31, 2022 Maturity Amortized Cost Unrealized Gains Unrealized Losses Fair Value U.S. Treasury bills Less than one year $ 217,669 $ — $ (465) $ 217,204 December 31, 2021 Maturity Amortized Cost Unrealized Gains Unrealized Losses Fair Value U.S. Treasury bills Less than one year $ 416,559 $ — $ (50) $ 416,509 As of December 31, 2022 and 2021, all marketable securities had contractual maturities less than one year, or marketable securities with maturities greater than one year are classified as current because management considers all marketable securities to be available for current operations. The Company does not intend to sell its marketable securities and it is not likely that the Company will be required to sell these securities before recovery of their amortized cost bases. There were $217.2 million and $416.5 million marketable securities classified as available-for-sale at December 31, 2022 and 2021, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases Obligations The Company currently leases office spaces and laboratory spaces located in Greater Los Angeles, California, Dallas, Texas, the United Kingdom and other parts of the United States. The Company's leased facilities have original lease terms ranging from 2 to 5 years that predominately require the Company to provide a security deposit, while certain leases provide the right for the Company to renew the lease upon the expiration of the initial lease term, and various leases have scheduled rent increases on an annual basis. The exercise of lease renewal options for the Company’s existing leases is at the Company’s sole discretion, and not included in the measurement of ROU asset or lease liability as they are not reasonably certain to be exercised. Certain leases provide free rent, or tenant improvement allowances, of which certain of these improvements have been classified as leasehold improvements and are being amortized over the shorter of the estimated useful life of the improvements or the remaining life of the lease, while other tenant improvements incurred by the Company revert to the landlord at the expiration of the lease and are not assets on the Company's consolidated balance sheets. Information related to the Company's operating ROU assets and related lease liability was as follows (in thousands, except for years and percentages): Company's lease costs consist of the following (in thousands): Year Ended December 31, 2022 Short-term lease cost $ 1,155 Operating lease cost 4,852 Variable lease cost 1,096 Total lease cost $ 7,103 The following table summarizes cash flow information related to the Company’s lease obligations (in thousands): Year Ended December 31, 2022 Cash paid for operating lease liabilities $ 3,258 The following table summarizes the Company’s lease assets and liabilities (in thousands): As of December 31, 2022 Operating lease right-of-use assets $ 12,457 Current operating lease liabilities $ 2,381 Non-current operating lease liabilities $ 5,171 The following table summarizes other supplemental information related to the Company’s lease obligations: As of December 31, 2022 Weighted-average remaining lease term (in years) 3.29 Weighted-average discount rate 6.75 % Future minimum lease payments under operating lease liabilities were (in thousands): As of December 31, 2022 2023 $ 2,806 2024 2,417 2025 1,920 2026 1,272 Total future lease payments 8,415 Less: imputed interest 863 Total lease liability balance 7,552 Less: current portion of operating lease liabilities 2,381 Total operating lease liabilities, non-current $ 5,171 Under ASC 840, rent expense recognized under the leases was $3.0 million for the year ended December 31, 2021. Future minimum lease payments under noncancellable operating leases as of December 31, 2021 were as follows (in thousands): As of December 31, 2021 2022 $ 2,411 2023 2,354 2024 2,215 2025 1,936 2026 1,272 Total $ 10,188 Construction Commitments The Company’s contractual commitments for the development of the Tarzana project are limited to unreimbursed spend by the general contractor and as such, as of December 31, 2022, was $4.0 million, which is contractually committed to the development of this project. Legal Proceedings From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position, results of operations or cash flows. Debt In June 2022, the Company’s wholly-owned subsidiary, Complex Therapeutics Mezzanine LLC, and the Company's wholly-owned indirect subsidiary, Complex Therapeutics LLC, entered into a mortgage construction loan and mezzanine construction loan (together, the “Loan”) secured by its Tarzana, California land and building (the “Property”) which is partially complete. The initial principal amount of the Loan was $52.1 million, with additional future principal of up to $32.9 million to fund ongoing Property construction costs. The Loan principal is payable in July 2025, with the option to extend until July 2027. As of December 31, 2022, the outstanding principal amount under the Loan was $74.8 million and unamortized debt issuance costs were $2.4 million. The Loan is guaranteed by the Company and secured by the Property, and bears interest at one-month Secured Overnight Financing Rate, plus 5.25% per annum. The Company's effective interest rate during the year ended December 31, 2022 was approximately 7.3%. The Loan contains customary negative and affirmative covenants that include limitations on the ability of the Company to enter into significant contracts and incur additional debt. The Company is also required to maintain consolidated net worth and liquid assets of at least $85.0 million as of December 31, 2022 and 2021 as defined in the loan agreement. As of December 31, 2022, the Company was in compliance with the covenants of the Loan. The Company is also required to maintain certain insurance coverage on the Property. In connection with the Loan, the Company entered into an interest rate swap to effectively limit its maximum interest rate, as discussed in Note 5. The net carrying amount of the Loan was as follows (in thousands): As of December 31, 2022 Principal amount $ 74,755 Unamortized debt issuance cost (2,405) Net carrying amount $ 72,350 The following table sets forth the interest expense recognized related to the Loan (in thousands): Year Ended December 31, 2022 Contractual interest expense $ 1,302 Amortization of debt issuance cost 581 Total interest expense related to the Loan $ 1,883 Indemnifications The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. The Company currently has directors’ and officers’ insurance coverage that reduces its exposure and enables the Company to recover a portion of any future amounts paid. No liability associated with such indemnifications was recorded as of December 31, 2022 and 2021. Other Commitments In the normal course of business, we enter into contracts and various purchase agreements commitments with third-party vendors for clinical research services, products and other services from third parties for operating purposes. These agreements generally provide for termination or cancellation, other than for costs already incurred. As of December 31, 2022, the Company had non-cancelable purchase commitments of approximately $18.3 million consisting mainly of contract research organizations, software and operating commitments. The Company also recorded $3.0 million in commitments elated to one-time employee termination benefits and $2.4 million in commitments for contract termination as part of the Plan (see Note 12). |
Commitments and Contingencies | Commitments and Contingencies Operating Leases Obligations The Company currently leases office spaces and laboratory spaces located in Greater Los Angeles, California, Dallas, Texas, the United Kingdom and other parts of the United States. The Company's leased facilities have original lease terms ranging from 2 to 5 years that predominately require the Company to provide a security deposit, while certain leases provide the right for the Company to renew the lease upon the expiration of the initial lease term, and various leases have scheduled rent increases on an annual basis. The exercise of lease renewal options for the Company’s existing leases is at the Company’s sole discretion, and not included in the measurement of ROU asset or lease liability as they are not reasonably certain to be exercised. Certain leases provide free rent, or tenant improvement allowances, of which certain of these improvements have been classified as leasehold improvements and are being amortized over the shorter of the estimated useful life of the improvements or the remaining life of the lease, while other tenant improvements incurred by the Company revert to the landlord at the expiration of the lease and are not assets on the Company's consolidated balance sheets. Information related to the Company's operating ROU assets and related lease liability was as follows (in thousands, except for years and percentages): Company's lease costs consist of the following (in thousands): Year Ended December 31, 2022 Short-term lease cost $ 1,155 Operating lease cost 4,852 Variable lease cost 1,096 Total lease cost $ 7,103 The following table summarizes cash flow information related to the Company’s lease obligations (in thousands): Year Ended December 31, 2022 Cash paid for operating lease liabilities $ 3,258 The following table summarizes the Company’s lease assets and liabilities (in thousands): As of December 31, 2022 Operating lease right-of-use assets $ 12,457 Current operating lease liabilities $ 2,381 Non-current operating lease liabilities $ 5,171 The following table summarizes other supplemental information related to the Company’s lease obligations: As of December 31, 2022 Weighted-average remaining lease term (in years) 3.29 Weighted-average discount rate 6.75 % Future minimum lease payments under operating lease liabilities were (in thousands): As of December 31, 2022 2023 $ 2,806 2024 2,417 2025 1,920 2026 1,272 Total future lease payments 8,415 Less: imputed interest 863 Total lease liability balance 7,552 Less: current portion of operating lease liabilities 2,381 Total operating lease liabilities, non-current $ 5,171 Under ASC 840, rent expense recognized under the leases was $3.0 million for the year ended December 31, 2021. Future minimum lease payments under noncancellable operating leases as of December 31, 2021 were as follows (in thousands): As of December 31, 2021 2022 $ 2,411 2023 2,354 2024 2,215 2025 1,936 2026 1,272 Total $ 10,188 Construction Commitments The Company’s contractual commitments for the development of the Tarzana project are limited to unreimbursed spend by the general contractor and as such, as of December 31, 2022, was $4.0 million, which is contractually committed to the development of this project. Legal Proceedings From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position, results of operations or cash flows. Debt In June 2022, the Company’s wholly-owned subsidiary, Complex Therapeutics Mezzanine LLC, and the Company's wholly-owned indirect subsidiary, Complex Therapeutics LLC, entered into a mortgage construction loan and mezzanine construction loan (together, the “Loan”) secured by its Tarzana, California land and building (the “Property”) which is partially complete. The initial principal amount of the Loan was $52.1 million, with additional future principal of up to $32.9 million to fund ongoing Property construction costs. The Loan principal is payable in July 2025, with the option to extend until July 2027. As of December 31, 2022, the outstanding principal amount under the Loan was $74.8 million and unamortized debt issuance costs were $2.4 million. The Loan is guaranteed by the Company and secured by the Property, and bears interest at one-month Secured Overnight Financing Rate, plus 5.25% per annum. The Company's effective interest rate during the year ended December 31, 2022 was approximately 7.3%. The Loan contains customary negative and affirmative covenants that include limitations on the ability of the Company to enter into significant contracts and incur additional debt. The Company is also required to maintain consolidated net worth and liquid assets of at least $85.0 million as of December 31, 2022 and 2021 as defined in the loan agreement. As of December 31, 2022, the Company was in compliance with the covenants of the Loan. The Company is also required to maintain certain insurance coverage on the Property. In connection with the Loan, the Company entered into an interest rate swap to effectively limit its maximum interest rate, as discussed in Note 5. The net carrying amount of the Loan was as follows (in thousands): As of December 31, 2022 Principal amount $ 74,755 Unamortized debt issuance cost (2,405) Net carrying amount $ 72,350 The following table sets forth the interest expense recognized related to the Loan (in thousands): Year Ended December 31, 2022 Contractual interest expense $ 1,302 Amortization of debt issuance cost 581 Total interest expense related to the Loan $ 1,883 Indemnifications The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. The Company currently has directors’ and officers’ insurance coverage that reduces its exposure and enables the Company to recover a portion of any future amounts paid. No liability associated with such indemnifications was recorded as of December 31, 2022 and 2021. Other Commitments In the normal course of business, we enter into contracts and various purchase agreements commitments with third-party vendors for clinical research services, products and other services from third parties for operating purposes. These agreements generally provide for termination or cancellation, other than for costs already incurred. As of December 31, 2022, the Company had non-cancelable purchase commitments of approximately $18.3 million consisting mainly of contract research organizations, software and operating commitments. The Company also recorded $3.0 million in commitments elated to one-time employee termination benefits and $2.4 million in commitments for contract termination as part of the Plan (see Note 12). |
Equity
Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Equity | Equity Common Stock Each share of common stock has the right to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and if declared by the Board of Directors, subject to the prior rights of holders of all classes of stock outstanding having priority rights as to dividends. No cash dividends have been declared by the board of directors from inception. In November 2020, the Company executed a limited recourse promissory note with its Chief Executive Officer, Bronson Crouch, in the amount of $1.1 million which was secured by a pledge of a total of 3.2 million shares of its common stock issued upon exercise of vested stock options. The note bore an interest rate of 2.5% per annum with a maturity date of the earlier of (i) five years from the date of the note or (ii) one On March 23, 2021, the Company completed its IPO through an underwritten sale of an aggregate of 18,400,000 shares of its common stock at a price of $20.00 per share (see Note 2). As of December 31, 2022, the Company had outstanding 130,079,097 shares of common stock. Preferred Stock Activity All then outstanding shares of convertible preferred stock were converted into an aggregate of 89,220,699 shares of common stock on March 23, 2021, the closing date of the Company's IPO (see Note 2). After the completion of the IPO, the Company's current amended and restated certificate of incorporation authorizes the Company to issue up to 10,000,000 shares of preferred stock at $0.000001 par value per share. The Board of Directors is authorized to provide for the issuance of the preferred stock in one or more series, and to fix the number of shares and to determine or alter for each such series, such voting powers, full or limited, or no voting powers, and such designation, preferences, and relative, participating, optional, or other rights and such qualifications, limitations, or restrictions thereof, as shall be stated and expressed in subsequent resolution or resolutions adopted by the board providing for the issuance of such shares. As of December 31, 2022 and 2021 there were no shares of preferred stock issued nor outstanding. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2021 Equity Incentive Plan In March 2021, the Company adopted the 2021 Equity Incentive Plan (the “2021 Plan”), which became effective in connection with the IPO. The 2021 Plan was approved by the Company’s Board of Directors and stockholders in March 2021. The 2021 Plan is an equity incentive plan pursuant to which the Company may grant the following awards: (i) incentive stock options; (ii) nonstatutory stock options; (iii) stock appreciation rights; (iv) restricted stock awards; (v) restricted stock unit awards; (vi) performance awards; and (vii) other forms of stock awards to employees, directors, and consultants, including employees and consultants of the Company’s affiliates. The 2021 Plan is a successor to the Company's 2018 Stock Incentive Plan (the “2018 Plan”). Following the effectiveness of the 2021 Plan, no further grants may be made under the 2018 Plan; however, any outstanding equity awards granted under the 2018 Plan will continue to be governed by the terms of the 2018 Plan. The number of shares available for future issuance under the 2021 Plan is the sum of (1) 8,660,000 new shares of common stock, (2) 4,194,437 remaining shares of common stock reserved under the 2018 Plan that became available for issuance upon the effectiveness of the 2021 Plan and (3) the number of shares of common stock subject to outstanding awards under the 2018 Plan when the 2021 Plan became effective that thereafter expire or are forfeited, canceled, withheld to satisfy tax withholding or to purchase or exercise an award, repurchased by the Company or are otherwise terminated. The number of shares of common stock reserved for issuance under the 2021 Plan will automatically increase on January 1 of each year, for a period of ten years, from January 1, 2022 continuing through January 1, 2031, by 5% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Company’s Board of Directors. Stock options granted by the Company to employees generally vest over four years with a one-year cliff. As of December 31, 2022, 8,095,739 shares of common stock remained available for issuance under the 2021 Plan. As of December 31, 2022, the total number of shares authorized for issuance under the 2021 Plan was 12,854,437 shares. The following summarizes option activity under the 2021 Plan: Shares Available for Grant Shares Issuable Under Options Weighted- Average Exercise Price Weighted- Average Remaining Contract Term (in years) Aggregate Intrinsic Value (in thousands) Balance, December 31, 2020 10,217,230 15,331,923 $ 0.80 9.22 $ 78,857 Additional Shares Authorized 8,660,000 Options granted (1) (9,413,187) 9,413,187 $ 9.96 Options forfeited 390,245 (390,245) $ 5.28 Options exercised (2) — (3,976,028) $ 0.44 Balance, December 31, 2021 9,854,288 20,378,837 $ 5.17 8.75 $ 247,880 Additional Shares Authorized — Options granted (1) (6,019,321) 6,019,321 $ 7.87 Options forfeited 4,260,772 (4,260,772) $ 7.69 Options exercised — (1,050,819) $ 1.47 Balance, December 31, 2022 8,095,739 21,086,567 $ 5.61 7.22 $ 711 Exercisable, December 31, 2022 9,925,790 $ 3.86 6.56 $ 709 Vested and expected to vest, December 31, 2022 9,925,790 $ 3.86 6.56 $ 709 ______________________________________________________________ (1) Includes 295,237 and 2,519,137 stock options during the years ended December 31, 2022 and 2021, respectively, subject to only performance conditions. (2) Excludes the exercise of 3,159,750 stock options that are subject to a limited recourse promissory note. The aggregate intrinsic value disclosed in the above table is based on the difference between the exercise price of the stock option and the estimated fair value of the Company’s common stock as of the respective period-end dates. There were 1,050,819 and 3,976,028 stock options exercised during the years ended December 31, 2022 and 2021, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2022 and 2021, was $0 million and $66.3 million, respectively. The weighted-average grant date fair value of stock options granted during the years ended December 31, 2022 and 2021, was $5.19 and $11.59 per share, respectively. The following table sets forth stock-based compensation included in the Company’s statement of operations and comprehensive loss (in thousands): Year Ended December 31, 2022 2021 Research and development expense $ 11,882 $ 12,912 General and administrative expense 18,559 13,285 Total stock-based compensation expense $ 30,441 $ 26,197 During 2022, the Company accelerated the vesting of 36,162 options held by 36 employees. As a result of that modification, the Company recognized a reversal of compensation expense of $0.2 million for the year ended December 31, 2022. Also during 2022, the Company extended the post-termination exercise period for 1,068,544 fully vested share options held by an employee. As a result of that modification, the Company recognized additional compensation expense of $0.1 million for the year ended December 31, 2022. As of December 31, 2022 and 2021, there was $55.0 million and $69.5 million of total unrecognized compensation cost related to unvested stock options granted under the 2021 Plan (excluding performance awards), which is expected to be recognized over a weighted average period of 1.98 years and 2.24 years, respectively. The fair value of the Company’s stock option awards was estimated at the date of grant using a Black-Scholes option pricing model with the following assumptions: Year Ended December 31, 2022 2021 Expected term (in years) 6.10 — 6.26 5.77 — 6.24 Expected volatility 72.08 % — 74.30% 72.52 % — 89.11% Risk-free interest rate 1.61 % — 4.21% 0.51 % — 1.44% Fair value of common stock $1.33 — $13.41 $5.95 — $26.44 Expected dividend yield —% —% Prior to the Company's IPO in March 2021, the fair value of the shares of common stock underlying stock options had historically been determined by the Company’s Board of Directors. Because there has been no public market for the Company’s common stock, the Board of Directors has determined fair value of the common stock at the time of grant of the option by considering a number of objective and subjective factors including important developments in the Company’s operations, contemporaneous valuations performed by an independent third party firm, sales of the Company’s convertible preferred stock, the Company’s operating results and financial performance, the conditions in the biotechnology industry and the economy in general, the stock price volatility of similar public companies and the lack of marketability of the Company’s common stock, among other factors. After the Company’s IPO in March 2021, the fair value of common stock is determined using the closing price of the Company’s common stock on the Nasdaq Global Select Market. The Black-Scholes option pricing model requires the use of highly subjective assumptions which determine the fair value of stock-based awards. These assumptions include: Expected term —The expected term represents the period that stock-based awards are expected to be outstanding and is determined as the average of the time-to-vesting and the contractual life of the awards. Expected volatility —Since the Company is privately held and does not have any trading history for its common stock, the expected volatility was estimated based on the average volatility for comparable publicly traded biotechnology companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle or area of specialty. Risk-free interest rate —The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of awards. Expected dividend yield —The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero. Performance Awards During the years ended December 31, 2022 and 2021, 295,237 and 2,519,137 stock options were granted to both employees and non-employees based upon performance conditions and strategic transactions. 2022 performance grants are expected to be recognized over a weighted average period of 3.17 years, and the 2021 performance grants are expected to be recognized over a weighted average period of 2.02 years. A strategic transaction has been defined as (a) a change in control, (b) certain corporate and business goals specific to the employee's performance or employment agreement. Included in stock-based compensation expense for the year ended December 31, 2022 is $5.9 million related to awards where performance conditions were achieved. As of December 31, 2022 and 2021, the Company had $10.6 million and $21.1 million of unrecognized compensation cost relating to these performance awards, calculated using the accelerated attribution method and the grant date fair value of the awards, respectively. Employee Stock Purchase Plan In March 2021, the Company adopted the Employee Stock Purchase Plan (the “ESPP”), which became effective in connection with the IPO. The ESPP was adopted by the Company’s Board of Directors and stockholders in March 2021. The ESPP initially provides participating employees with the opportunity to purchase up to an aggregate of 1,237,000 shares of common stock. The number of shares reserved under the 2021 ESPP will automatically increase on January 1 of each year, for a period of ten years, from January 1, 2022 continuing through January 1, 2031, in an amount equal to the lesser of (i) 1% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year and (ii) 2,474,000 shares; provided, however, that before the date of any such increase, the Board of Directors may determine that such increase will be less than the amount set forth in clauses (i) and (ii). The Company has not yet commenced offerings to employees under the ESPP. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect: December 31, 2022 2021 Stock options to purchase common stock 21,086,817 20,378,837 Total 21,086,817 20,378,837 All outstanding shares of convertible preferred stock were converted on a 1.2-for-1 conversion ratio of shares of common stock on March 23, 2021, the date of the Company's IPO (see Note 2). |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The geographical breakdown of loss before provision for income taxes is as follows (in thousands): Year Ended December 31, 2022 2021 Domestic $ (183,994) $ (154,778) Foreign (41,256) (1,977) Loss before income taxes $ (225,250) $ (156,755) The components of the provision for income taxes are as follows (in thousands): Year Ended December 31, 2022 2021 Current provision for income taxes: Domestic $ 13 $ — Foreign — — Total current 13 — Deferred tax provision: Domestic — 18 Foreign (2,086) 21 Total deferred (2,086) 39 Total income tax expense (benefit) $ (2,073) $ 39 The following table presents a reconciliation of the Company’s statutory federal income tax rate and effective tax rate: Year Ended December 31, 2022 2021 U.S. federal taxes at statutory rate 21.0 % 21.0 % Research and development tax credits — % 0.9 % Stock-based compensation (2.0) % (3.1) % Permanent differences and other 0.2 % (0.3) % Statutory tax rate differences 1.1 % 2.7 % Change in valuation allowance (19.4) % (21.2) % Total 0.9 % — % The components of deferred tax liabilities consist of the following (in thousands): Year Ended December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 58,259 $ 36,726 Research and development credits 4,915 4,682 Accrued compensation and benefits 352 2,364 Stock-based compensation 2,781 239 Capitalized Research and Development 20,966 505 Other temporary differences 517 1,033 Total gross deferred tax assets 87,790 45,549 Less: valuation allowance (86,285) (42,737) Total deferred tax assets, net 1,505 2,812 Deferred tax liabilities: Intangible assets — (2,672) Fixed assets (420) (2,566) Other (1,085) — Total gross deferred tax liabilities (1,505) (5,238) Net deferred tax liabilities $ — $ (2,426) The components of unrecognized tax benefits consist of the following (in thousands): Balance at December 31, 2021: $ 2,339 Additions in 2022 — Balance at December 31, 2022: $ 2,339 In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Due to the uncertainty of the business in which the Company operates, projections of future profitability are difficult and past profitability is not necessarily indicative of future profitability. The Company does not believe it is more likely than not that the deferred tax assets will be realized, and accordingly, the valuation allowance increased $43.5 million for the year ended December 31, 2022. As of December 31, 2022, the Company had net operating loss carryforwards for federal income tax purposes of $225.7 million, which will carryforward indefinitely, but may only offset 80% of the Company’s taxable income. This limitation on the net operating loss may require the Company to pay federal income taxes in future years despite generating a loss for federal income tax purposes in prior years. In addition, the Company has $25.1 million of net operating loss carryforwards available to reduce future taxable income, for California state income tax purposes for the year ended December 31, 2022. The state net operating loss carryforwards will begin to expire, if not utilized, in 2041. The Company has R&D credits of $4.1 million, and $3.7 million for federal and California, respectively, as of December 31, 2022. The federal R&D credits expire in 2040 and the California R&D credits carryforward indefinitely. The Company files income tax returns in the U.S. federal jurisdiction, various states where the Company has employees and/or significant business activities, and the United Kingdom. As of December 31, 2022, the Company’s federal and state returns through 2019 are still open to examination. The UK returns starting from 2016 are open to examination. The Company had uncertain tax positions as of December 31, 2021 of $2.3 million and this balance remained unchanged during December 31, 2022. The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly increase or decrease during the next 12 months. The Company had no accrued interest or penalties related to uncertain tax positions as of December 31, 2022. The Company has not completed a Section 382 study to assess whether an ownership change has occurred or whether there have been multiple ownership changes since the Company’s formation. Pursuant to Internal Revenue Code Sections 382 and 383, annual use of the Company’s net operating loss and research and development tax credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. Due to the existence of the valuation allowance, limitations created by future ownership changes, if any, will not impact the Company’s effective tax rate. |
Corporate Restructuring
Corporate Restructuring | 12 Months Ended |
Dec. 31, 2022 | |
Restructuring and Related Activities [Abstract] | |
Corporate Restructuring | Corporate Restructuring In December 2022, the Company’s Board of Directors approved a the Plan to implement a strategic prioritization of the Company’s preclinical and clinical development programs. The Plan is designed to reduce costs and reallocate resources to focus on advancing the Company’s CoStimulatory Antigen Receptor (CoStAR) platform and other next-generation tumor infiltrating lymphocyte (TIL) technologies. As part of the Plan, the Company’s ITIL-168 development program was discontinued, and the Company reduced its U.S. workforce by approximately 60%. Restructuring and Impairment Charges As a result of the Plan, in the year ended December 31, 2022, the Company recorded restructuring and impairment charges of approximately $23.2 million within the restructuring and impairment charges line item within the consolidated statements of operations and comprehensive loss. These charges relate to asset impairments, contract terminations, severance payments and other employee-related costs incurred. The following table summarizes the restructuring and impairment charges by category (in thousands): Year Ended December 31, 2022 Asset impairment for goodwill and intangible assets $ 15,826 Asset impairment for leasehold improvements 1,202 Asset impairment for other fixed assets 705 One-time employee termination benefits 2,995 Contract terminations 2,439 Total restructuring and impairment charges $ 23,167 Restructuring Liability The restructuring liability was recorded in the consolidated balance sheets under “Accrued expenses and other current liabilities” and were measured at the amount expected amount to be paid. During the year ended December 31, 2022, the Company did not pay restructuring charges and expects to pay the majority of the restructuring cost within the next 12 months. The following table shows the liability related to the Plan (in thousands): As of December, 31 2022 One-Time Employee Termination Benefits $ 2,995 Contract Termination 2,439 Restructuring liability balance $ 5,434 Corporate Restructuring Expansion Plan On January 30, 2023, the Company’s Board of Directors approved an expansion of its previously announced restructuring plan implementing a strategic prioritization of the Company’s preclinical and clinical development programs. In connection with the expanded restructuring plan (“the Expanded Plan”), the Company will extend its previously announced U.S. reduction in force, resulting in a team of approximately 15 in the United States to lead global business operations and approximately 65 employees in the United Kingdom for research, development, clinical studies and technical operations. The reduction is expected to be substantially completed by the end of April 2023. The Expanded Plan is designed to reduce operating expenses, which is expected to preserve financial resources and extend the Company’s cash runway beyond 2026 based on the Expanded Plan as currently contemplated. In connection with the Expanded Plan, the Company expects to transition clinical manufacturing and trial operations of ITIL-306 to its operations in the United Kingdom. In addition, the Company is evaluating opportunities for a potential sale or lease of its Tarzana, California manufacturing site, as well as subleases of other facilities currently under lease. The Company currently estimates that it will incur charges of up to $9.0 million in connection with the Expanded Plan, consisting primarily of cash expenditures for severance payments, retention bonus payments, contract terminations and related costs, as well as non-cash expenses related to vesting of share-based awards, excluding any charges or costs associated with any potential sale of its facilities and asset impairments, if any. The Company may incur additional costs associated with its restructuring plan. The Company expects that the majority of the restructuring charges will be incurred in the next 12 months and that the execution of the Expanded Plan will be substantially complete by the end of April 2023. The charges that the Company expects to incur in connection with the Expanded Plan are estimates and subject to a number of assumptions, and actual results may differ materially. The foregoing estimated amounts do not include any non-cash charges associated with stock-based compensation. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company and its wholly owned subsidiaries. Instil Bio (UK) Ltd. (formerly Immetacyte Ltd. (“Immetacyte”)) and Complex Therapeutics, LLC. Immetacyte was acquired on March 2, 2020 and Complex Therapeutics, LLC was incorporated on October 14, 2020. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not limited to the fair value of stock valuations prior to the Company's initial public offering, the fair value of contingent consideration payable and the estimation of fair value of goodwill and in-process research and development (IPR&D) intangible assets and associated impairment charges. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. |
Concentration of Credit Risk | Concentration of Credit Risk Financial Instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities. The Company's cash and cash equivalents are held by two financial institutions in the United States ("U.S.") and one financial institution in the United Kingdom ("UK"), which management believes to be financially sound, and accordingly, minimal credit risk exists with respect to the financial institutions. At times, the Company's deposits held in the U.S. and UK may exceed the Federal Depository Insurance Corporation and Financial Services Compensation Scheme, respectively, insured limits. |
Risks and Uncertainties | Risks and Uncertainties The Company is subject to a number of risks similar to other development-stage biopharmaceutical companies, including but not limited to, dependency on the clinical and commercial success of its product candidates, ability to obtain regulatory approval of its product candidates, uncertainty of broad adoption of its approved products, if any, |
Segments | Segments Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the chief operating decision-maker in deciding how to allocate resources to an individual segment and in assessing performance. The Company has determined it operates in a single operating segment and has one operating segment. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents, Restricted Cash and Marketable Securities The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents include amounts invested in money market accounts. Restricted cash consists of a money market account which serves as collateral for the Company’s employee corporate credit cards and is classified within other long-term assets on the consolidated balance sheet as of December 31, 2021. The Company did not have restricted cash on the consolidated balance sheet as of December 31, 2022. |
Marketable Securities | The Company's short-term marketable securities have original maturities of less than a year at date of purchase. The Company classifies and accounts for marketable securities as available-for-sale securities, which are carried at their fair values based on the quoted market prices of the securities. Unrealized gains and losses are reported as accumulated other comprehensive income (loss). Realized gains on available-for-sale securities are included in net loss in the period earned or incurred. As of December 31, 2022, marketable securities consisted of U.S. Treasury bills that the Company classifies within marketable securities on the consolidated balance sheets. Short-term marketable securities are recorded at their estimated fair value. The Company periodically reviews whether its securities may be other-than-temporarily impaired, including whether or not (i) the Company has the intent to sell the security or (ii) it is more likely than not that the Company will be required to sell the security before its anticipated recovery. If one of these factors is met, the Company will record an impairment loss associated with its impaired investment. The impairment loss will be recorded as a write-down of investments in the consolidated |
Fair Value Measurement | Fair Value Measurement Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company measures fair value based on a three-tier hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1 — Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2 — Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liabilities. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Property, Plant and Equipment, Net | Property, Plant and Equipment, Net Property, plant and equipment, with the exception of land, is stated at cost less accumulated depreciation. Depreciation is computed on a straight-line basis over the estimated useful lives of the related assets. Maintenance and repairs are charged to operations as incurred. Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the balance sheets and the resulting gain or loss is reflected in the consolidated statement of operations and comprehensive loss. The estimated useful lives of the Company’s property, plant and equipment are as follows: Laboratory equipment 5 years Manufacturing equipment 5 years Office and computer equipment 3 years Building 35 years Leasehold improvements Shorter of remaining lease term or estimated useful life |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable or that the useful life is shorter than originally estimated. Recoverability of assets is measured by comparing the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset over its remaining useful life. If such assets are impaired, the impairment recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. If the useful life is shorter than originally estimated, the Company depreciates or amortizes the remaining carrying value over the revised shorter useful life. Assets to be disposed of by sale are reflected at the lower of their carrying amount or fair value less cost to sell. To date, the Company has recorded impairment losses on long-lived assets associated with a sustained decrease in the Company's stock price and the Plan implemented on December 2, 2022 for a strategic prioritization of the Company’s preclinical and clinical development programs. The Company recognized a non-cash impairment charge of $1.9 million during the fourth quarter of 2022. The impairment charge was recorded in the consolidated statements of operations and comprehensive loss in the line item “restructuring and impairment charges.” See Note 12 for more information. |
Business Combinations | Business Combinations The Company evaluates acquisitions of assets and related liabilities and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the requirements of a business. The Company accounts for its business combinations using the acquisition method of accounting which requires recognition and measurement of all identifiable assets acquired and liabilities assumed at their full fair value as of the date it obtains control. The Company has determined the fair value of assets acquired and liabilities assumed based upon management's estimates of the fair values of assets acquired and liabilities assumed in the acquisitions. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable assets acquired. The Company accounts for contingent considerations at the acquisition-date fair value as part of the consideration transferred in the transaction and remeasures at fair value for each reporting period. While management has used its best estimates and assumptions to measure the fair value of the identifiable assets acquired and liabilities assumed at the acquisition date, these estimates are inherently uncertain and subject to refinement. As a result, during the measurement period, not to exceed one year from the date of acquisition, any changes in the estimated fair values of the net assets recorded for the acquisition will result in an adjustment to goodwill. Upon the conclusion of the measurement period of final determination of the values of assets acquired or liabilities assumed, whichever comes first, the Company records any subsequent adjustments to the consolidated statements of operations and comprehensive loss. Acquisition-related costs, such as legal and consulting fees, are expensed as incurred. |
Goodwill and other Indefinite Lived Intangible Assets | Goodwill and other Indefinite Lived Intangible Assets Indefinite-lived intangible assets consist of goodwill and IPR&D acquired in a business combination. Goodwill represents the excess of the purchase price over the fair value of the net tangible and intangible assets acquired in a business combination. Goodwill is not amortized but is tested for impairment at least annually or more frequently if a triggering event occurs . The Company’s impairment tests are based on a single operating segment and reporting unit structure. If the carrying value of the reporting unit exceeds its fair value, an impairment charge is recognized for the excess of the carrying value of the reporting unit over its fair value (see Note 12). IPR&D assets represent the fair value of incomplete research and development projects that had not reached technological feasibility as of the date of acquisition; initially, these are classified as IPR&D and are not subject to amortization. Once these research and development projects are completed, the asset balances are transferred from IPR&D to acquisition-related developed technology and are subject to amortization from this point forward. The Company reviews IPR&D for possible impairment annually or more frequently if events or changes in circumstances indicate that carrying amount may not be recoverable. Significant assumptions inherent in the evaluation and measurement of impairment include, but are not limited to, external factors such as industry and economic trends, and internal factors such as changes in the Company’s business strategy and the Company’s forecasts for specific projects (see Note 12). During the year ended December 31, 2022, there was $15.8 million in impairment of Goodwill & IPR&D recognized in the consolidated statement of operations and comprehensive loss in the line item "restructuring and impairment charges". |
Grant Proceeds | Grant ProceedsThe Company receives government grants in the UK for the furtherance of certain research and development projects. Grant proceeds are recognized when all conditions of such grants are fulfilled or there is a reasonable assurance that they will be fulfilled. Grant proceeds are classified as a reduction of research and development expenses. |
Research and Development Expenses | Research and Development Expenses Research and development (“R&D”) costs are expensed as incurred. Advance payments for research and development activities are deferred as prepaid expenses, classified as current or noncurrent on the Company’s consolidated balance sheets based on the estimated timing the related services will be performed and are expensed as the related services are performed. Costs incurred by third parties pursuant to contracts with research institutions and clinical research organizations are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from the external service providers. The Company adjusts its accrual as actual costs become known. If the actual timing of the performance of services or the level of effort varies significantly from the estimate, the Company will adjust the accrual accordingly. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception. Research and development expenses are presented net of government grants, as described above, and R&D tax and expenditure credits from the UK government, which are recognized over the period necessary to match the reimbursement with the related costs when it is probable that the Company has complied with any conditions |
Stock-Based Compensation | Stock-Based Compensation The Company measures its stock-based awards granted to employees, non-employee directors, consultants and independent advisors based on the estimated grant date fair value of the awards. For stock-based awards with only service conditions, compensation expense is recognized over the requisite service period using the straight-line method. For stock-based awards that include performance conditions, compensation expense is not recognized until the performance condition is probable to occur. The Company uses the Black-Scholes option pricing model to estimate the fair value of its stock-based awards. The Black-Scholes option pricing model requires the Company to make assumptions and judgements about the variables used in the calculations, including the fair value of common stock, expected term, expected volatility of the Company’s common stock, risk-free interest rate and expected dividend yield. The Company accounts for forfeitures of stock-based awards as they occur. |
Income Taxes | Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts or existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period of enactment. The Company records a valuation allowance to reduce deferred tax assets to an amount expected to be realized. The Company recognizes the tax benefit from an uncertain tax position if it is more likely than not that the tax position will be sustained upon examination by the tax authorities, based on the merits of the position. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. |
Foreign Currency | Foreign Currency The Company’s reporting currency is the U.S. dollar. The functional currency of the Company’s subsidiary located in the United Kingdom is the British Sterling. Balance sheets prepared in the functional currency are translated to the reporting currency at exchange rates in effect at the end of the accounting period, except for stockholders’ deficit accounts, which are translated at rates in effect when these balances were originally recorded. Revenue and expense accounts are translated using an average exchange rate in effect during the period. The resulting foreign currency translation adjustments are recorded as a separate component of accumulated other comprehensive loss in the accompanying consolidated balance sheets. Gains and losses resulting from exchange rate changes on intercompany transactions denominated in a currency other than the local currency are included in earnings as incurred as the related amounts are expected to be repaid in the foreseeable future. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of the Company’s common stock outstanding for the period, without consideration for potential dilutive shares of common stock. For purposes of the diluted net loss per share calculation, convertible preferred stock and common stock options are considered to be potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for each period presented since the effects of potentially dilutive securities are antidilutive given the net loss of the Company. |
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. For the year ended December 31, 2022, comprehensive loss consists of foreign currency translation adjustments, and unrealized loss on available-for-sale securities net of tax. For the year ended December 31, 2021, comprehensive loss consists of foreign currency translation adjustments and unrealized loss on available-for-sale securities. |
Leases | Leases The Company adopted the new standard Accounting Standards Updated ("ASU") No. 2016-2, Leases effective January 1, 2022 using the modified retrospective transition approach. For its long-term operating leases, the Company recognizes a right-of-use asset and a lease liability on its consolidated balance sheets. The Company determines if an arrangement is or contains a lease at contract inception by assessing whether the arrangement contains an identified asset and whether the lessee has the right to control such asset. Lessees are required to classify leases as either finance or operating leases and to record a right-of-use (“ROU”) asset and a lease liability for all leases with a term greater than 12 months regardless of the lease classification. The lease classification will determine whether the lease expense is recognized based on an effective interest rate method or on a straight-line basis over the term of the lease. The Company determines the initial classification and measurement of its ROU assets and lease liabilities at the lease commencement date and thereafter if modified. For leases with a term greater than 12 months, the Company records the lease liability at the present value of lease payments over the term. The term of the Company’s leases equals the non-cancellable period of the lease, including any rent-free periods provided by the lessor, and also includes options to extend or terminate the lease that the Company is reasonably certain to exercise. The ROU asset equals the carrying amount of the related lease liability, adjusted for any lease payments made prior to lease commencement, any deferred rent upon adoption, and lease incentives provided by the lessor. The Company has elected, for all classes of underlying assets, not to recognize ROU assets and lease liabilities for leases with a term of 12 months or less. Lease cost for short-term leases is recognized on a straight-line basis over the lease term. The Company estimates its incremental borrowing rate based on the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Variable lease payments are expensed as incurred and do not factor into the measurement of the applicable ROU asset or lease liability. Lease payments may be fixed or variable; however, only fixed payments are included in the Company’s lease liability calculation. Lease costs for the Company’s operating leases are recognized on a straight-line basis within operating expenses over the lease term. The Company’s lease agreements may contain non-lease components such as common area maintenance, operating expenses or other costs, which are expensed as incurred for all classes of assets. The Company’s leases do not contain any residual value guarantees. |
Recent Accounting Pronouncements Adopted | Recent Accounting Pronouncements Adopted In February 2016, the Financial Accounting Standards Board ("FASB") issued ASU No. 2016-02 $12.5 million and $7.6 million , respectively, to reflect the present value of remaining lease payments under existing lease arrangements. The Company applied the modified retrospective transition approach and did not recast prior periods. As permitted by the standard, the Company elected the transition practical expedient package, which among other things, allows the carryforward of historical lease classifications. The Company’s new accounting policies around leases are described in Leases, above, and in Note 7, Commitments and Contingencies. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. Additionally, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, in April 2019 and ASU 2019-05, Financial Instruments — Credit Losses (Topic 326) — Targeted Transition Relief, in May 2019. The amendments affect loans, debt securities, trade receivables, net investments in leases, off-balance-sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. The Company adopted this standard on January 1, 2022. The adoption of this standard did not have a material impact on the Company's consolidated financial statements and disclosures. In December 2019, the FASB issued ASU No. 2019-12. Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The standard simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and also improves consistent application by clarifying and amending existing guidance. The Company adopted this standard on January 1, 2022 . The adoption of this standard did not have a material impact on the Company's consolidated financial statements and disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule 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 amounts shown in the consolidated statements of cash flows (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 43,716 $ 37,590 Restricted cash — 500 Cash, cash equivalents and restricted cash $ 43,716 $ 38,090 |
Schedule 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 amounts shown in the consolidated statements of cash flows (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 43,716 $ 37,590 Restricted cash — 500 Cash, cash equivalents and restricted cash $ 43,716 $ 38,090 |
Schedule of Useful Lives | The estimated useful lives of the Company’s property, plant and equipment are as follows: Laboratory equipment 5 years Manufacturing equipment 5 years Office and computer equipment 3 years Building 35 years Leasehold improvements Shorter of remaining lease term or estimated useful life Property, plant and equipment, net consist of the following (in thousands): December 31, 2022 2021 Land $ 31,243 $ 31,243 Laboratory equipment 19,050 13,962 Buildings (1) 32,778 6,034 Office and computer equipment 4,969 2,239 Leasehold improvements 4,340 1,836 Manufacturing equipment 8,803 1,717 Vehicles 64 64 Construction work-in-progress 104,117 67,883 Total property, plant and equipment, gross 205,364 124,978 Less: accumulated depreciation (8,484) (2,979) Total property, plant and equipment, net $ 196,880 $ 121,999 ______________________________________________________________ (1) Relates to a building which was developed as part of the Company’s clinical manufacturing facility in Tarzana, California. The building was placed into service and ready for its intended use as of the end of the quarter ended June 30, 2022. |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Property, Plant and Equipment, Net | The estimated useful lives of the Company’s property, plant and equipment are as follows: Laboratory equipment 5 years Manufacturing equipment 5 years Office and computer equipment 3 years Building 35 years Leasehold improvements Shorter of remaining lease term or estimated useful life Property, plant and equipment, net consist of the following (in thousands): December 31, 2022 2021 Land $ 31,243 $ 31,243 Laboratory equipment 19,050 13,962 Buildings (1) 32,778 6,034 Office and computer equipment 4,969 2,239 Leasehold improvements 4,340 1,836 Manufacturing equipment 8,803 1,717 Vehicles 64 64 Construction work-in-progress 104,117 67,883 Total property, plant and equipment, gross 205,364 124,978 Less: accumulated depreciation (8,484) (2,979) Total property, plant and equipment, net $ 196,880 $ 121,999 ______________________________________________________________ (1) Relates to a building which was developed as part of the Company’s clinical manufacturing facility in Tarzana, California. The building was placed into service and ready for its intended use as of the end of the quarter ended June 30, 2022. |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands): December 31, 2022 2021 Accrued construction costs $ 12,359 $ 12,085 Accrued compensation and benefits 3,273 11,928 Accrued operational expenses 2,203 5,292 Accrued restructuring costs 5,434 — Accrued research, development and clinical trial expenses 3,827 4,234 Operating lease liabilities, current 2,381 — Current tax liabilities — 524 Other current liabilities 592 386 Total accrued expenses and other current liabilities $ 30,069 $ 34,449 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following tables provide information by level for assets and liabilities that are measured at fair value on a recurring basis: As of December 31, 2022 Level 1 Level 2 Level 3 Total (In thousands) Financial Assets Money market funds $ 22,830 $ — $ — $ 22,830 U.S. Treasury bills — 217,204 — 217,204 Derivative financial instrument — 2,202 — 2,202 Total $ 22,830 $ 219,406 $ — $ 242,236 Financial Liabilities Contingent consideration $ — $ — $ 8,242 $ 8,242 As of December 31, 2021 Level 1 Level 2 Level 3 Total (In thousands) Financial Assets Money market funds $ 18,493 $ — $ — $ 18,493 U.S. Treasury bills — 416,509 — 416,509 Total $ 18,493 $ 416,509 $ — $ 435,002 Financial Liabilities Contingent consideration $ — $ — $ 12,321 $ 12,321 |
Reconciliation of Level 3 Financial Liabilities | The following table sets forth a summary of the changes in the fair value of the Company's Level 3 financial liabilities (in thousands): Year Ended December 31, 2022 Fair value, beginning balance $ 12,321 Change in fair value (2,879) Development milestone achieved (1,200) Fair value, ending balance $ 8,242 Year Ended December 31, 2021 Fair value, beginning balance $ 12,277 Change in fair value 294 Development milestone achieved (250) Fair value, ending balance $ 12,321 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Securities | Marketable securities classified as available-for-sale at December 31, 2022 and 2021 consisted of the following (in thousands): December 31, 2022 Maturity Amortized Cost Unrealized Gains Unrealized Losses Fair Value U.S. Treasury bills Less than one year $ 217,669 $ — $ (465) $ 217,204 December 31, 2021 Maturity Amortized Cost Unrealized Gains Unrealized Losses Fair Value U.S. Treasury bills Less than one year $ 416,559 $ — $ (50) $ 416,509 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lease Cost | Information related to the Company's operating ROU assets and related lease liability was as follows (in thousands, except for years and percentages): Company's lease costs consist of the following (in thousands): Year Ended December 31, 2022 Short-term lease cost $ 1,155 Operating lease cost 4,852 Variable lease cost 1,096 Total lease cost $ 7,103 The following table summarizes cash flow information related to the Company’s lease obligations (in thousands): Year Ended December 31, 2022 Cash paid for operating lease liabilities $ 3,258 The following table summarizes the Company’s lease assets and liabilities (in thousands): As of December 31, 2022 Operating lease right-of-use assets $ 12,457 Current operating lease liabilities $ 2,381 Non-current operating lease liabilities $ 5,171 The following table summarizes other supplemental information related to the Company’s lease obligations: As of December 31, 2022 Weighted-average remaining lease term (in years) 3.29 Weighted-average discount rate 6.75 % |
Schedule of Future Minimum Lease Payments | Future minimum lease payments under operating lease liabilities were (in thousands): As of December 31, 2022 2023 $ 2,806 2024 2,417 2025 1,920 2026 1,272 Total future lease payments 8,415 Less: imputed interest 863 Total lease liability balance 7,552 Less: current portion of operating lease liabilities 2,381 Total operating lease liabilities, non-current $ 5,171 |
Schedule of Future Minimum Lease Payments Under Noncancellable Operating Leases | Future minimum lease payments under noncancellable operating leases as of December 31, 2021 were as follows (in thousands): As of December 31, 2021 2022 $ 2,411 2023 2,354 2024 2,215 2025 1,936 2026 1,272 Total $ 10,188 |
Schedule of Net Carrying Amount of the Loan | The net carrying amount of the Loan was as follows (in thousands): As of December 31, 2022 Principal amount $ 74,755 Unamortized debt issuance cost (2,405) Net carrying amount $ 72,350 |
Schedule of Interest Expense Related to the Loan | The following table sets forth the interest expense recognized related to the Loan (in thousands): Year Ended December 31, 2022 Contractual interest expense $ 1,302 Amortization of debt issuance cost 581 Total interest expense related to the Loan $ 1,883 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Option Activity | The following summarizes option activity under the 2021 Plan: Shares Available for Grant Shares Issuable Under Options Weighted- Average Exercise Price Weighted- Average Remaining Contract Term (in years) Aggregate Intrinsic Value (in thousands) Balance, December 31, 2020 10,217,230 15,331,923 $ 0.80 9.22 $ 78,857 Additional Shares Authorized 8,660,000 Options granted (1) (9,413,187) 9,413,187 $ 9.96 Options forfeited 390,245 (390,245) $ 5.28 Options exercised (2) — (3,976,028) $ 0.44 Balance, December 31, 2021 9,854,288 20,378,837 $ 5.17 8.75 $ 247,880 Additional Shares Authorized — Options granted (1) (6,019,321) 6,019,321 $ 7.87 Options forfeited 4,260,772 (4,260,772) $ 7.69 Options exercised — (1,050,819) $ 1.47 Balance, December 31, 2022 8,095,739 21,086,567 $ 5.61 7.22 $ 711 Exercisable, December 31, 2022 9,925,790 $ 3.86 6.56 $ 709 Vested and expected to vest, December 31, 2022 9,925,790 $ 3.86 6.56 $ 709 ______________________________________________________________ (1) Includes 295,237 and 2,519,137 stock options during the years ended December 31, 2022 and 2021, respectively, subject to only performance conditions. (2) Excludes the exercise of 3,159,750 stock options that are subject to a limited recourse promissory note. |
Schedule of Stock-Based Compensation Expense | The following table sets forth stock-based compensation included in the Company’s statement of operations and comprehensive loss (in thousands): Year Ended December 31, 2022 2021 Research and development expense $ 11,882 $ 12,912 General and administrative expense 18,559 13,285 Total stock-based compensation expense $ 30,441 $ 26,197 |
Schedule of Valuation Assumptions | The fair value of the Company’s stock option awards was estimated at the date of grant using a Black-Scholes option pricing model with the following assumptions: Year Ended December 31, 2022 2021 Expected term (in years) 6.10 — 6.26 5.77 — 6.24 Expected volatility 72.08 % — 74.30% 72.52 % — 89.11% Risk-free interest rate 1.61 % — 4.21% 0.51 % — 1.44% Fair value of common stock $1.33 — $13.41 $5.95 — $26.44 Expected dividend yield —% —% |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Net Loss Per Share | The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect: December 31, 2022 2021 Stock options to purchase common stock 21,086,817 20,378,837 Total 21,086,817 20,378,837 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Geographical Breakdown of Loss before Provision for Income Taxes | The geographical breakdown of loss before provision for income taxes is as follows (in thousands): Year Ended December 31, 2022 2021 Domestic $ (183,994) $ (154,778) Foreign (41,256) (1,977) Loss before income taxes $ (225,250) $ (156,755) |
Schedule of Components of the Provision for Income Taxes | The components of the provision for income taxes are as follows (in thousands): Year Ended December 31, 2022 2021 Current provision for income taxes: Domestic $ 13 $ — Foreign — — Total current 13 — Deferred tax provision: Domestic — 18 Foreign (2,086) 21 Total deferred (2,086) 39 Total income tax expense (benefit) $ (2,073) $ 39 |
Schedule of Effective Income Tax Rate Reconciliation | The following table presents a reconciliation of the Company’s statutory federal income tax rate and effective tax rate: Year Ended December 31, 2022 2021 U.S. federal taxes at statutory rate 21.0 % 21.0 % Research and development tax credits — % 0.9 % Stock-based compensation (2.0) % (3.1) % Permanent differences and other 0.2 % (0.3) % Statutory tax rate differences 1.1 % 2.7 % Change in valuation allowance (19.4) % (21.2) % Total 0.9 % — % |
Schedule of Deferred Tax Assets and Liabilities | The components of deferred tax liabilities consist of the following (in thousands): Year Ended December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 58,259 $ 36,726 Research and development credits 4,915 4,682 Accrued compensation and benefits 352 2,364 Stock-based compensation 2,781 239 Capitalized Research and Development 20,966 505 Other temporary differences 517 1,033 Total gross deferred tax assets 87,790 45,549 Less: valuation allowance (86,285) (42,737) Total deferred tax assets, net 1,505 2,812 Deferred tax liabilities: Intangible assets — (2,672) Fixed assets (420) (2,566) Other (1,085) — Total gross deferred tax liabilities (1,505) (5,238) Net deferred tax liabilities $ — $ (2,426) |
Schedule of Unrecognized Tax Benefits Roll Forward | The components of unrecognized tax benefits consist of the following (in thousands): Balance at December 31, 2021: $ 2,339 Additions in 2022 — Balance at December 31, 2022: $ 2,339 |
Corporate Restructuring (Tables
Corporate Restructuring (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Total Amount Expected to be Incurred and Liability | The following table summarizes the restructuring and impairment charges by category (in thousands): Year Ended December 31, 2022 Asset impairment for goodwill and intangible assets $ 15,826 Asset impairment for leasehold improvements 1,202 Asset impairment for other fixed assets 705 One-time employee termination benefits 2,995 Contract terminations 2,439 Total restructuring and impairment charges $ 23,167 |
Schedule of Realignment Non-cash Charges | The following table shows the liability related to the Plan (in thousands): As of December, 31 2022 One-Time Employee Termination Benefits $ 2,995 Contract Termination 2,439 Restructuring liability balance $ 5,434 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Mar. 23, 2021 USD ($) $ / shares shares | Mar. 12, 2021 | Mar. 31, 2021 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) shares | Mar. 24, 2021 shares | Dec. 31, 2020 shares | |
Subsidiary, Sale of Stock [Line Items] | ||||||||
Stock split (in shares) | 1.2 | |||||||
Underwriting discounts and commissions | $ 25,800 | |||||||
Other offering expenses | $ 3,200 | |||||||
Net proceeds from sale of stock | $ 339,000 | |||||||
Shares issued upon conversion (in shares) | shares | 89,220,699 | |||||||
Common stock, shares authorized (in shares) | shares | 300,000,000 | |||||||
Convertible preferred stock, shares authorized (in shares) | shares | 10,000,000 | |||||||
Convertible preferred stock outstanding (in shares) | shares | 0 | 0 | 70,176,046 | |||||
Number of segments | segment | 1 | |||||||
Impairment of long lived asset held for use | $ 1,900 | |||||||
Impairment of goodwill and intangible assets | $ 15,800 | |||||||
Grant proceeds | 1,600 | $ 1,700 | ||||||
Reimbursable research and development tax and expenditure credits | 3,100 | $ 1,800 | ||||||
Accounting standards update, extensible enumeration | Accounting Standards Update 2016-02 [Member] | |||||||
Operating lease right-of-use assets | 12,457 | 12,457 | $ 0 | |||||
Total lease liability balance | $ 7,552 | $ 7,552 | ||||||
Cumulative Effect, Period of Adoption, Adjustment | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Operating lease right-of-use assets | 12,500 | |||||||
Total lease liability balance | $ 7,600 | |||||||
IPO | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Shares sold (in shares) | shares | 18,400,000 | |||||||
Price per share sold (in dollars per share) | $ / shares | $ 20 | |||||||
Underwriter purchase option | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Shares sold (in shares) | shares | 2,400,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 43,716 | $ 37,590 | |
Restricted cash | 0 | 500 | |
Cash, cash equivalents and restricted cash | $ 43,716 | $ 38,090 | $ 241,764 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Useful Life (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Manufacturing equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Office and computer equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Building | |
Property, Plant and Equipment [Line Items] | |
Useful life | 35 years |
Balance Sheet Components - Prop
Balance Sheet Components - Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | $ 205,364 | $ 124,978 |
Less: accumulated depreciation | (8,484) | (2,979) |
Total property, plant and equipment, net | 196,880 | 121,999 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 31,243 | 31,243 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 19,050 | 13,962 |
Buildings | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 32,778 | 6,034 |
Office and computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 4,969 | 2,239 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 4,340 | 1,836 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 8,803 | 1,717 |
Vehicles | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | 64 | 64 |
Construction work-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment, gross | $ 104,117 | $ 67,883 |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation expense | $ 6,000 | $ 2,700 |
Payments to acquire buildings | 84,589 | $ 57,831 |
Work in progress | 104,000 | |
Construction work-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Interest related to qualifying expenditures | $ 1,200 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued construction costs | $ 12,359 | $ 12,085 |
Accrued compensation and benefits | 3,273 | 11,928 |
Accrued operational expenses | 2,203 | 5,292 |
Accrued restructuring costs | 5,434 | 0 |
Accrued research, development and clinical trial expenses | 3,827 | 4,234 |
Operating lease liabilities, current | 2,381 | 0 |
Current tax liabilities | 0 | 524 |
Other current liabilities | 592 | 386 |
Total accrued expenses and other current liabilities | $ 30,069 | $ 34,449 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total accrued expenses and other current liabilities |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill [Line Items] | ||||
Goodwill, Impairment Loss | $ 15,826 | $ 0 | ||
Immetacyte | ||||
Goodwill [Line Items] | ||||
Percentage of share capital acquired | 100% | |||
IPR&D assets acquired | $ 10,100 | |||
Goodwill acquired | $ 5,700 | |||
Goodwill, Impairment Loss | $ 5,700 | |||
Impairment of intangibles | $ 10,100 |
Fair Value Measurement - Financ
Fair Value Measurement - Financial Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Financial Assets | ||
U.S. Treasury bills | $ 217,200 | $ 416,500 |
U.S. Treasury bills | ||
Financial Assets | ||
U.S. Treasury bills | 217,204 | 416,509 |
Fair Value, Recurring | ||
Financial Assets | ||
Derivative financial instrument | 2,202 | |
Total | 242,236 | 435,002 |
Financial Liabilities | ||
Contingent consideration | 8,242 | 12,321 |
Fair Value, Recurring | U.S. Treasury bills | ||
Financial Assets | ||
U.S. Treasury bills | 217,204 | 416,509 |
Fair Value, Recurring | Money market funds | ||
Financial Assets | ||
Money market funds | 22,830 | 18,493 |
Fair Value, Recurring | Level 1 | ||
Financial Assets | ||
Derivative financial instrument | 0 | |
Total | 22,830 | 18,493 |
Financial Liabilities | ||
Contingent consideration | 0 | 0 |
Fair Value, Recurring | Level 1 | U.S. Treasury bills | ||
Financial Assets | ||
U.S. Treasury bills | 0 | 0 |
Fair Value, Recurring | Level 1 | Money market funds | ||
Financial Assets | ||
Money market funds | 22,830 | 18,493 |
Fair Value, Recurring | Level 2 | ||
Financial Assets | ||
Derivative financial instrument | 2,202 | |
Total | 219,406 | 416,509 |
Financial Liabilities | ||
Contingent consideration | 0 | 0 |
Fair Value, Recurring | Level 2 | U.S. Treasury bills | ||
Financial Assets | ||
U.S. Treasury bills | 217,204 | 416,509 |
Fair Value, Recurring | Level 2 | Money market funds | ||
Financial Assets | ||
Money market funds | 0 | 0 |
Fair Value, Recurring | Level 3 | ||
Financial Assets | ||
Derivative financial instrument | 0 | |
Total | 0 | 0 |
Financial Liabilities | ||
Contingent consideration | 8,242 | 12,321 |
Fair Value, Recurring | Level 3 | U.S. Treasury bills | ||
Financial Assets | ||
U.S. Treasury bills | 0 | 0 |
Fair Value, Recurring | Level 3 | Money market funds | ||
Financial Assets | ||
Money market funds | $ 0 | $ 0 |
Fair Value Measurement - Narrat
Fair Value Measurement - Narrative (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Derivative Asset, Statement of Financial Position [Extensible Enumeration] | Other long-term assets | ||
Contingent consideration payments | $ 1.2 | $ 0.3 | |
Measurement Input, Discount Rate | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Measurement input | 0.08 | ||
Minimum | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Payment probability | 20% | ||
Maximum | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Payment probability | 100% | ||
Secured Mortgage Loan | Level 2 | Loans Payable | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Fair value of loan | $ 69 |
Fair Value Measurement - Level
Fair Value Measurement - Level 3 Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value, beginning balance | $ 12,321 | $ 12,277 |
Change in fair value | (2,879) | 294 |
Development milestone achieved | (1,200) | 250 |
Fair value, ending balance | $ 8,242 | $ 12,321 |
Financial Instruments - Summary
Financial Instruments - Summary of Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
U.S. Treasury bills | $ 217,200 | $ 416,500 |
U.S. Treasury bills | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 217,669 | 416,559 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (465) | (50) |
U.S. Treasury bills | $ 217,204 | $ 416,509 |
Financial Instruments - Narrati
Financial Instruments - Narrative (Details) - USD ($) $ in Millions | Dec. 31, 2022 | Dec. 31, 2021 |
Investments, Debt and Equity Securities [Abstract] | ||
Available-for-sale | $ 217.2 | $ 416.5 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Lessee, Lease, Description [Line Items] | |||
Rent expense | $ 3,000,000 | ||
One-time employee termination benefits | Restructuring Plan | |||
Lessee, Lease, Description [Line Items] | |||
Restructuring charges | $ 2,995,000 | ||
Contract terminations | Restructuring Plan | |||
Lessee, Lease, Description [Line Items] | |||
Restructuring charges | 2,439,000 | ||
Non Cancelable Purchase Commitments with Contract Research Organizations | |||
Lessee, Lease, Description [Line Items] | |||
Non-cancelable purchase commitments | 18,300,000 | ||
Non Cancelable Purchase Commitments with Contract Research Organizations | One-time employee termination benefits | Restructuring Plan | |||
Lessee, Lease, Description [Line Items] | |||
Restructuring charges | 3,000,000 | ||
Non Cancelable Purchase Commitments with Contract Research Organizations | Contract terminations | Restructuring Plan | |||
Lessee, Lease, Description [Line Items] | |||
Restructuring charges | 2,400,000 | ||
Secured Mortgage Loan | Loans Payable | |||
Lessee, Lease, Description [Line Items] | |||
Initial principal amount | $ 52,100,000 | 74,755,000 | |
Debt issuance costs | $ 2,405,000 | ||
Effective interest rate | 7.30% | ||
Covenant, minimum net worth | $ 85,000,000 | 85,000,000 | |
Secured Mortgage Loan | Loans Payable | SOFR | |||
Lessee, Lease, Description [Line Items] | |||
Basis interest | 5.25% | ||
Tarzana Land and Building Acquired | |||
Lessee, Lease, Description [Line Items] | |||
Contractual commitment | $ 4,000,000 | $ 63,200,000 | |
Minimum | |||
Lessee, Lease, Description [Line Items] | |||
Original lease terms | 2 years | ||
Maximum | |||
Lessee, Lease, Description [Line Items] | |||
Original lease terms | 5 years | ||
Maximum | Secured Mortgage Loan | Loans Payable | |||
Lessee, Lease, Description [Line Items] | |||
Initial principal amount | $ 32,900,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Lease Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Short-term lease cost | $ 1,155 | |
Operating lease cost | 4,852 | |
Variable lease cost | 1,096 | |
Total lease cost | 7,103 | |
Cash paid for operating lease liabilities | 3,258 | |
Operating lease right-of-use assets | 12,457 | $ 0 |
Current operating lease liabilities | 2,381 | 0 |
Non-current operating lease liabilities | $ 5,171 | $ 0 |
Weighted-average remaining lease term (in years) | 3 years 3 months 14 days | |
Weighted-average discount rate | 6.75% |
Commitments and Contingencies_3
Commitments and Contingencies - Future Minimum Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
2023 | $ 2,806 | |
2024 | 2,417 | |
2025 | 1,920 | |
2026 | 1,272 | |
Total future lease payments | 8,415 | |
Less: imputed interest | (863) | |
Total lease liability balance | 7,552 | |
Less: current portion of operating lease liabilities | (2,381) | $ 0 |
Total operating lease liabilities, non-current | $ 5,171 | 0 |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | ||
2022 | 2,411 | |
2023 | 2,354 | |
2024 | 2,215 | |
2025 | 1,936 | |
2026 | 1,272 | |
Total | $ 10,188 |
Commitments and Contingencies_4
Commitments and Contingencies - Net Carrying Amount of the Liability Component of the Loan (Details) - Secured Mortgage Loan - Loans Payable - USD ($) | Dec. 31, 2022 | Jun. 30, 2022 |
Debt Instrument [Line Items] | ||
Principal amount | $ 74,755,000 | $ 52,100,000 |
Unamortized debt issuance cost | (2,405,000) | |
Net carrying amount | $ 72,350,000 |
Commitments and Contingencies_5
Commitments and Contingencies - Interest Expense Related to the Loan (Details) - Secured Mortgage Loan - Loans Payable $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Interest Expense Related to the Loan [Line Items] | |
Contractual interest expense | $ 1,302 |
Amortization of debt issuance cost | 581 |
Total interest expense related to the Loan | $ 1,883 |
Equity (Details)
Equity (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Mar. 23, 2021 $ / shares shares | Nov. 30, 2020 USD ($) shares | Dec. 31, 2021 shares | Dec. 31, 2022 vote shares | Mar. 24, 2021 $ / shares shares | Dec. 31, 2020 shares | |
Class of Stock [Line Items] | ||||||
Common stock, votes per share | vote | 1 | |||||
Promissory note | $ | $ 1.1 | |||||
Promissory note secured by pledge, number of shares (in shares) | 3,200,000 | |||||
Interest rate | 2.50% | |||||
Promissory note, term | 5 years | |||||
Promissory note, days prior to filing of first registration statement | 1 day | |||||
Common stock, shares outstanding (in shares) | 129,028,278 | 130,079,097 | ||||
Convertible preferred stock outstanding (in shares) | 0 | 0 | 70,176,046 | |||
Issuance of convertible preferred shares (in shares) | 4,174,551 | |||||
Shares issued upon conversion (in shares) | 89,220,699 | |||||
Convertible preferred stock, shares authorized (in shares) | 10,000,000 | |||||
Convertible preferred stock, par value (in dollars per share) | $ / shares | $ 0.000001 | |||||
Convertible preferred stock issued (in shares) | 0 | 0 | ||||
IPO | ||||||
Class of Stock [Line Items] | ||||||
Shares sold (in shares) | 18,400,000 | |||||
Price per share sold (in dollars per share) | $ / shares | $ 20 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2021 shares | Dec. 31, 2022 USD ($) employee $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Additional shares authorized (in shares) | 8,660,000 | 0 | 8,660,000 |
Shares available for future issuance (in shares) | 8,095,739 | ||
Term to authorize additional shares | 10 years | ||
Percentage of outstanding capital stock | 5% | ||
Shares authorized (in shares) | 12,854,437 | ||
Options exercised (in shares) | 1,050,819 | 3,976,028 | |
Aggregate intrinsic value of options exercised | $ | $ 0 | $ 66,300 | |
Options granted, weighted-average grant date fair value (in dollars per share) | $ / shares | $ 5.19 | $ 11.59 | |
Total stock-based compensation expense | $ | $ 30,441 | $ 26,197 | |
Unrecognized compensation cost | $ | $ 55,000 | $ 69,500 | |
Unrecognized compensation cost, recognition period | 1 year 11 months 23 days | 2 years 2 months 26 days | |
Options granted (in shares) | 6,019,321 | 9,413,187 | |
Minimum number of additional shares to be authorized (in shares) | 2,474,000 | ||
Share-Based Payment Arrangement, 36 Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options vested (in shares) | 36,162 | ||
Number of employee | employee | 36 | ||
Total stock-based compensation expense | $ | $ (200) | ||
Share-Based Payment Arrangement, One Employee | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options vested (in shares) | 1,068,544 | ||
Additional compensation expense | $ | $ 100 | ||
Stock options to purchase common stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected dividend yield | 0% | 0% | |
Performance Shares | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ | $ 5,900 | ||
Unrecognized compensation cost | $ | $ 10,600 | $ 21,100 | |
Options granted (in shares) | 295,237 | 2,519,137 | |
Employee Stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Term to authorize additional shares | 10 years | ||
Percentage of outstanding capital stock | 1% | ||
Shares authorized (in shares) | 1,237,000 | ||
Weighted Average | Performance Shares | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 3 years 2 months 1 day | 2 years 7 days | |
Share-based Payment Arrangement, Tranche One | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 4 years | ||
Share-based Payment Arrangement, Tranche One | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 1 year | ||
2018 Stock Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares available for future issuance (in shares) | 4,194,437 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Shares Available for Grant | ||||
Beginning balance (in shares) | 9,854,288 | 10,217,230 | ||
Additional Shares Authorized (in shares) | 8,660,000 | 0 | 8,660,000 | |
Options granted (in shares) | (6,019,321) | (9,413,187) | ||
Options forfeited (in shares) | 4,260,772 | 390,245 | ||
Ending balance (in shares) | 8,095,739 | 9,854,288 | 10,217,230 | |
Shares Issuable Under Options | ||||
Beginning balance (in shares) | 20,378,837 | 15,331,923 | ||
Options granted (in shares) | 6,019,321 | 9,413,187 | ||
Options forfeited (in shares) | (4,260,772) | (390,245) | ||
Options exercised (in shares) | (1,050,819) | (3,976,028) | ||
Ending balance (in shares) | 21,086,567 | 20,378,837 | 15,331,923 | |
Exercisable (in shares) | 9,925,790 | |||
Vested and expected to vest (in shares) | 9,925,790 | |||
Weighted- Average Exercise Price | ||||
Beginning balance (in dollars per share) | $ 5.17 | $ 0.80 | ||
Options granted (in dollars per share) | 7.87 | 9.96 | ||
Options forfeited (in dollars per share) | 7.69 | 5.28 | ||
Options exercised (in dollars per share) | 1.47 | 0.44 | ||
Ending balance (in dollars per share) | 5.61 | $ 5.17 | $ 0.80 | |
Exercisable, weighted-average exercise price (in dollars per share) | 3.86 | |||
Vested and expected to vest, weighted-average exercise price (in dollars per share) | $ 3.86 | |||
Balance, weighted-average remaining contract term | 7 years 2 months 19 days | 8 years 9 months | 9 years 2 months 19 days | |
Exercisable, weighted-average remaining contract term | 6 years 6 months 21 days | |||
Vested and expected to vest, weighted-average remaining contract term | 6 years 6 months 21 days | |||
Balance, aggregate intrinsic value | $ 711 | $ 247,880 | $ 78,857 | |
Exercisable, aggregate intrinsic value | 709 | |||
Vested and expected to vest, aggregate intrinsic value | $ 709 | |||
Performance Shares | ||||
Shares Available for Grant | ||||
Options granted (in shares) | (295,237) | (2,519,137) | ||
Shares Issuable Under Options | ||||
Options granted (in shares) | 295,237 | 2,519,137 | ||
Stock options subject to limited recourse promissory note | ||||
Shares Issuable Under Options | ||||
Options exercised (in shares) | (3,159,750) |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 30,441 | $ 26,197 |
Research and development expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 11,882 | 12,912 |
General and administrative expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 18,559 | $ 13,285 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation Assumption (Details) - Stock option - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, minimum | 72.08% | 72.52% |
Expected volatility, maximum | 74.30% | 89.11% |
Risk-free interest rate, minimum | 1.61% | 0.51% |
Risk-free interest rate, maximum | 4.21% | 1.44% |
Expected dividend yield | 0% | 0% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | 5 years 9 months 7 days |
Fair Value of Common Stock (in dollars per share) | $ 1.33 | $ 5.95 |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 3 months 3 days | 6 years 2 months 26 days |
Fair Value of Common Stock (in dollars per share) | $ 13.41 | $ 26.44 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) | 12 Months Ended | ||
Mar. 23, 2021 | Dec. 31, 2022 shares | Dec. 31, 2021 shares | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive shares (in shares) | 21,086,817 | 20,378,837 | |
Conversion ratio | 1.2 | ||
Stock options to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive shares (in shares) | 21,086,817 | 20,378,837 |
Income Taxes - Loss before Inco
Income Taxes - Loss before Income Tax Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ (183,994) | $ (154,778) |
Foreign | (41,256) | (1,977) |
Loss before income tax expense | $ (225,250) | $ (156,755) |
Income Taxes - Current and Defe
Income Taxes - Current and Deferred Income Tax Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current provision for income taxes: | ||
Domestic | $ 13 | $ 0 |
Foreign | 0 | 0 |
Total current | 13 | 0 |
Deferred tax provision: | ||
Domestic | 0 | 18 |
Foreign | (2,086) | 21 |
Total deferred | (2,086) | 39 |
Total income tax expense (benefit) | $ (2,073) | $ 39 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal taxes at statutory rate | 21% | 21% |
Research and development tax credits | 0% | 0.90% |
Stock-based compensation | (2.00%) | (3.10%) |
Permanent differences and other | 0.20% | (0.30%) |
Statutory tax rate differences | 1.10% | 2.70% |
Change in valuation allowance | (19.40%) | (21.20%) |
Total | 0.90% | 0% |
Income Taxes - Deferred Income
Income Taxes - Deferred Income Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 58,259 | $ 36,726 |
Research and development credits | 4,915 | 4,682 |
Accrued compensation and benefits | 352 | 2,364 |
Stock-based compensation | 2,781 | 239 |
Capitalized Research and Development | 20,966 | 505 |
Other temporary differences | 517 | 1,033 |
Total gross deferred tax assets | 87,790 | 45,549 |
Less: valuation allowance | (86,285) | (42,737) |
Total deferred tax assets, net | 1,505 | 2,812 |
Deferred tax liabilities: | ||
Intangible assets | 0 | (2,672) |
Fixed assets | (420) | (2,566) |
Other | (1,085) | 0 |
Total gross deferred tax liabilities | (1,505) | (5,238) |
Net deferred tax liabilities | $ 0 | $ (2,426) |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |
Balance at December 31, 2021: | $ 2,339 |
Additions in 2022 | 0 |
Balance at December 31, 2022: | $ 2,339 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Increase in valuation allowance | $ (43,500) | |
Uncertain tax positions | 2,339 | $ 2,339 |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 225,700 | |
Federal | Research & Development credits | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credits carryforward | 4,100 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 25,100 | |
State | Research & Development credits | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credits carryforward | $ 3,700 |
Corporate Restructuring - Narra
Corporate Restructuring - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restructuring Cost and Reserve [Line Items] | ||
Restructuring liability balance | $ 5,434 | $ 0 |
Asset impairment and other | 15,800 | |
Restructuring Plan | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring liability balance | 5,434 | |
Asset impairment and other | 15,826 | |
Expected restructuring costs remaining | 9,000 | |
Restructuring Plan | Software and Software Development Costs | ||
Restructuring Cost and Reserve [Line Items] | ||
Impairment of goodwill and intangible assets | $ 705 |
Corporate Restructuring - Restr
Corporate Restructuring - Restructuring costs by category (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restructuring Cost and Reserve [Line Items] | ||
Asset impairment and other | $ 15,800 | |
Total restructuring and impairment charges | 23,167 | $ 0 |
Restructuring Plan | ||
Restructuring Cost and Reserve [Line Items] | ||
Asset impairment and other | 15,826 | |
Total restructuring and impairment charges | 23,167 | |
Restructuring Plan | One-time employee termination benefits | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring charges | 2,995 | |
Restructuring Plan | Contract terminations | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring charges | 2,439 | |
Restructuring Plan | Leasehold improvements | ||
Restructuring Cost and Reserve [Line Items] | ||
Impairment of goodwill and intangible assets | $ 1,202 |
Corporate Restructuring - Res_2
Corporate Restructuring - Restructuring Liability (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Restructuring Cost and Reserve [Line Items] | ||
Restructuring liability balance | $ 5,434 | $ 0 |
Restructuring Plan | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring liability balance | 5,434 | |
Restructuring Plan | One-time employee termination benefits | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring liability balance | 2,995 | |
Restructuring Plan | Contract terminations | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring liability balance | $ 2,439 |