Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 01, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ALLK | |
Entity Registrant Name | Allakos Inc. | |
Entity Central Index Key | 0001564824 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 54,844,080 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-38582 | |
Entity Tax Identification Number | 45-4798831 | |
Entity Address, Address Line One | 825 Industrial Road | |
Entity Address, Address Line Two | Suite 500 | |
Entity Address, City or Town | San Carlos | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94070 | |
City Area Code | 650 | |
Local Phone Number | 597-5002 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE |
BALANCE SHEETS (Unaudited)
BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 82,452 | $ 152,822 |
Investments | 129,987 | 271,416 |
Prepaid expenses and other current assets | 9,427 | 27,343 |
Total current assets | 221,866 | 451,581 |
Property and equipment, net | 41,300 | 43,100 |
Operating lease right-of-use assets | 31,962 | 31,707 |
Other long-term assets | 11,781 | 8,436 |
Total assets | 306,909 | 534,824 |
Current liabilities: | ||
Accounts payable | 9,865 | 13,692 |
Accrued expenses and other current liabilities | 26,638 | 26,557 |
Total current liabilities | 36,503 | 40,249 |
Operating lease liabilities, net of current portion | 47,597 | 49,099 |
Total liabilities | 84,100 | 89,348 |
Contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value per share; 20,000 shares authorized as of June 30, 2022 and December 31, 2021; no shares issued and outstanding as of June 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.001 par value per share; 200,000 shares authorized as of June 30, 2022 and December 31, 2021; [54,761] and 54,622 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 54 | 54 |
Additional paid-in capital | 1,081,965 | 1,058,399 |
Accumulated other comprehensive loss | (260) | (153) |
Accumulated deficit | (858,950) | (612,824) |
Total stockholders’ equity | 222,809 | 445,476 |
Total liabilities and stockholders’ equity | $ 306,909 | $ 534,824 |
BALANCE SHEETS (Unaudited) (Par
BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 54,844,000 | 54,622,000 |
Common stock, shares outstanding | 54,844,000 | 54,622,000 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses | ||||
Research and development | $ 34,448 | $ 40,985 | $ 211,255 | $ 79,900 |
General and administrative | 14,669 | 16,210 | 33,513 | 32,880 |
Total operating expenses | 49,117 | 57,195 | 244,768 | 112,780 |
Loss from operations | (49,117) | (57,195) | (244,768) | (112,780) |
Interest income | 104 | 103 | 187 | 233 |
Other expense, net | (90) | (117) | (1,545) | (220) |
Net loss | (49,103) | (57,209) | (246,126) | (112,767) |
Unrealized gain (loss) on investments | 209 | (56) | (107) | 24 |
Comprehensive loss | $ (48,894) | $ (57,265) | $ (246,233) | $ (112,743) |
Net loss per common share: | ||||
Net loss per common share, basic | $ (0.90) | $ (1.07) | $ (4.50) | $ (2.11) |
Net loss per common share, diluted | $ (0.90) | $ (1.07) | $ (4.50) | $ (2.11) |
Weighted-average number of common shares outstanding: | ||||
Weighted-average shares of common stock outstanding, basic | 54,798,000 | 53,669,000 | 54,742,000 | 53,429,000 |
Weighted-average shares of common stock outstanding, diluted | 54,798,000 | 53,669,000 | 54,742,000 | 53,429,000 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Gain | Accumulated Deficit |
Balance at Dec. 31, 2020 | $ 654,395 | $ 53 | $ 997,298 | $ 8 | $ (342,964) |
Balance, Shares at Dec. 31, 2020 | 53,081 | ||||
Stock-based compensation expense | 12,354 | $ 0 | 12,354 | 0 | 0 |
Issuance of common stock upon exercise of stock options | 3,788 | $ 0 | 3,788 | 0 | 0 |
Issuance of common stock upon exercise of stock options, Shares | 321 | ||||
Issuance of common stock upon 2018 ESPP purchase | 995 | $ 0 | 995 | 0 | 0 |
Issuance of common stock upon 2018 ESPP purchase, Shares | 17 | ||||
Issuance of common stock upon vesting of restricted stock units | 0 | $ 0 | 0 | 0 | 0 |
Issuance of common stock upon vesting of restricted stock units, Shares | 38 | ||||
Unrealized gain (loss) on investments | 80 | $ 0 | 0 | 80 | 0 |
Net loss | (55,558) | 0 | 0 | 0 | (55,558) |
Balance at Mar. 31, 2021 | 616,054 | $ 53 | 1,014,435 | 88 | (398,522) |
Balance, Shares at Mar. 31, 2021 | 53,457 | ||||
Balance at Dec. 31, 2020 | 654,395 | $ 53 | 997,298 | 8 | (342,964) |
Balance, Shares at Dec. 31, 2020 | 53,081 | ||||
Unrealized gain (loss) on investments | 24 | ||||
Net loss | (112,767) | ||||
Balance at Jun. 30, 2021 | 570,986 | $ 53 | 1,026,632 | 32 | (455,731) |
Balance, Shares at Jun. 30, 2021 | 53,936 | ||||
Balance at Mar. 31, 2021 | 616,054 | $ 53 | 1,014,435 | 88 | (398,522) |
Balance, Shares at Mar. 31, 2021 | 53,457 | ||||
Stock-based compensation expense | 11,397 | $ 0 | 11,397 | 0 | 0 |
Issuance of common stock upon exercise of stock options | 800 | $ 0 | 800 | 0 | 0 |
Issuance of common stock upon exercise of stock options, Shares | 443 | ||||
Issuance of common stock upon vesting of restricted stock units | 0 | $ 0 | 0 | 0 | 0 |
Issuance of common stock upon vesting of restricted stock units, Shares | 36 | ||||
Unrealized gain (loss) on investments | (56) | $ 0 | 0 | (56) | 0 |
Net loss | (57,209) | 0 | 0 | 0 | (57,209) |
Balance at Jun. 30, 2021 | 570,986 | $ 53 | 1,026,632 | 32 | (455,731) |
Balance, Shares at Jun. 30, 2021 | 53,936 | ||||
Balance at Dec. 31, 2021 | 445,476 | $ 54 | 1,058,399 | (153) | (612,824) |
Balance, Shares at Dec. 31, 2021 | 54,622 | ||||
Stock-based compensation expense | 11,392 | $ 0 | 11,392 | 0 | 0 |
Issuance of common stock upon exercise of stock options | 104 | $ 0 | 104 | 0 | 0 |
Issuance of common stock upon exercise of stock options, Shares | 34 | ||||
Issuance of common stock upon 2018 ESPP purchase | 243 | $ 0 | 243 | 0 | 0 |
Issuance of common stock upon 2018 ESPP purchase, Shares | 42 | ||||
Issuance of common stock upon vesting of restricted stock units | 0 | $ 0 | 0 | 0 | 0 |
Issuance of common stock upon vesting of restricted stock units, Shares | 63 | ||||
Unrealized gain (loss) on investments | (316) | $ 0 | 0 | (316) | 0 |
Net loss | (197,023) | 0 | 0 | 0 | (197,023) |
Balance at Mar. 31, 2022 | 259,876 | $ 54 | 1,070,138 | (469) | (809,847) |
Balance, Shares at Mar. 31, 2022 | 54,761 | ||||
Balance at Dec. 31, 2021 | $ 445,476 | $ 54 | 1,058,399 | (153) | (612,824) |
Balance, Shares at Dec. 31, 2021 | 54,622 | ||||
Issuance of common stock upon exercise of stock options, Shares | 59 | ||||
Unrealized gain (loss) on investments | $ (107) | ||||
Net loss | (246,126) | ||||
Balance at Jun. 30, 2022 | 222,809 | $ 54 | 1,081,965 | (260) | (858,950) |
Balance, Shares at Jun. 30, 2022 | 54,844 | ||||
Balance at Mar. 31, 2022 | 259,876 | $ 54 | 1,070,138 | (469) | (809,847) |
Balance, Shares at Mar. 31, 2022 | 54,761 | ||||
Stock-based compensation expense | 11,761 | $ 0 | 11,761 | 0 | 0 |
Issuance of common stock upon exercise of stock options | 66 | $ 0 | 66 | 0 | 0 |
Issuance of common stock upon exercise of stock options, Shares | 25 | ||||
Issuance of common stock upon vesting of restricted stock units | 0 | $ 0 | 0 | 0 | 0 |
Issuance of common stock upon vesting of restricted stock units, Shares | 58 | ||||
Unrealized gain (loss) on investments | 209 | $ 0 | 0 | 209 | 0 |
Net loss | (49,103) | 0 | 0 | 0 | (49,103) |
Balance at Jun. 30, 2022 | $ 222,809 | $ 54 | $ 1,081,965 | $ (260) | $ (858,950) |
Balance, Shares at Jun. 30, 2022 | 54,844 |
STATEMENTS OF CASH FLOWS (unaud
STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (246,126) | $ (112,767) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 4,064 | 747 |
Stock-based compensation | 23,153 | 23,751 |
Net amortization of premiums and discounts on investments | 1,616 | 1,211 |
Noncash lease expense | 961 | 1,541 |
Loss on disposal of property and equipment | 28 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 17,621 | (4,072) |
Other long-term assets | (4,148) | (13,844) |
Accounts payable | (3,645) | (2,034) |
Accrued expenses and other current liabilities | 1,969 | 7,952 |
Operating lease liabilities, net of current portion | (2,550) | 1,474 |
Net cash used in operating activities | (207,057) | (96,041) |
Cash flows from investing activities | ||
Purchases of investments | (19,988) | (215,461) |
Proceeds from sales of investments | 19,989 | 0 |
Proceeds from maturities of investments | 140,000 | 310,000 |
Proceeds from sale of property and equipment | 1,169 | 0 |
Purchases of property and equipment | (5,699) | (7,302) |
Net cash provided by investing activities | 135,471 | 87,237 |
Cash flows from financing activities | ||
Proceeds from exercise of stock options | 170 | 4,588 |
Proceeds from issuance of common stock under the 2018 ESPP | 243 | 995 |
Net cash provided by financing activities | 413 | 5,583 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (71,173) | (3,221) |
Cash, cash equivalents and restricted cash, beginning of period | 155,097 | 209,452 |
Cash, cash equivalents and restricted cash, end of period | 83,924 | 206,231 |
Noncash investing and financing items: | ||
Lessor-funded lease incentives included in property and equipment | 0 | 5,348 |
Increase (decrease) in payables related to purchase of property and equipment | $ (2,238) | $ 4,786 |
Organization and Business
Organization and Business | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | 1. Organization and Business Allakos Inc. (“Allakos” or the “Company”) was incorporated in the state of Delaware in March 2012. Allakos is a clinical stage biopharmaceutical company focused on the development of lirentelimab (AK002) and AK006 for the treatment of eosinophil and mast cell related diseases. The Company’s primary activities to date have included establishing its facilities, recruiting personnel, conducting research and development of its product candidates and raising capital. The Company’s operations are located in San Carlos, California. The Company operates in one reportable segment. Since inception, the Company has incurred net losses and negative cash flows from operations. During the six months ended June 30, 2022, the Company incurred a net loss of $ 246.1 million and used $ 207.1 million of cash in operations. At June 30, 2022, the Company had an accumulated deficit of $ 859.0 million and does not expect to experience positive cash flows from operating activities in the foreseeable future. The Company has financed its operations to date primarily through the sale of common stock. Management expects to incur additional operating losses in the future as the Company continues to further develop, seek regulatory approval for and, if approved, commence commercialization of its product candidates. Due to the clinical study results released in December 2021, our Board of Directors approved in February 2022 plans to reduce our contractual commitments and a reorganization plan (the “Reorganization Plan”) to reduce operating costs and better align our workforce with the clinical development plans of our business. As part of this, the Company entered into a termination agreement (the “Termination Agreement”) with Lonza AG, Lonza Sales Ltd and Lonza Sales AG (collectively, “Lonza AG”) regarding all outstanding manufacturing service agreements in February 2022. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited interim financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”). The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes. The interim balance sheet as of June 30, 2022, the statements of operations and comprehensive loss, statements of stockholders’ equity and statements of cash flows for the six months ended June 30, 2022 and 2021 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial position as of June 30, 2022 and its results of operations and comprehensive loss for the three and six months ended June 30, 2022 and 2021 and its cash flows for the six months ended June 30, 2022 and 2021. Certain information and note disclosures normally included in annual audited financial statements prepared in accordance with U.S. GAAP have been omitted. The financial data and the other financial information disclosed in these notes to the interim financial statements are also unaudited. The results of operations for any interim period are not necessarily indicative of the results to be expected for the entire year or for any other future annual or interim period. The balance sheet as of June 30, 2022 included herein was derived from the audited financial statements as of that date. These interim financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2022. Use of Estimates Management uses significant judgment when making estimates related to common stock valuation and related stock-based compensation expense, accrued research and development expense, and lease-related assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates under different assumptions or conditions, and those differences could be material to the financial position and results of operations. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to credit risk principally consist of cash, cash equivalents and investments. These financial instruments are held in accounts at a single financial institution that management believes possesses high credit quality. Amounts on deposit with this financial institution have and will continue to exceed federally-insured limits. The Company has not experienced any losses on its cash deposits. Additionally, the Company’s investment policy limits its investments to certain types of securities issued by or backed by the U.S. government and its agencies. The Company is subject to a number of risks similar to that of other early stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future clinical trials, its reliance on third-parties to conduct its clinical trials, the need to obtain regulatory and marketing approvals for its product candidates, competitive developments, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, protection of proprietary technology, the ability to make milestone, royalty or other payments due under licensing agreements, and the need to secure and maintain adequate manufacturing arrangements with third-parties. If the Company does not successfully commercialize or partner its product candidates, it will be unable to generate product revenue or achieve profitability. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Company’s balance sheets and which, in aggregate, represent the amounts reported in the accompanying statements of cash flows (in thousands): June 30, December 31, 2022 2021 Cash and cash equivalents $ 82,452 $ 152,822 Restricted cash in other long-term assets 1,472 2,275 Total $ 83,924 $ 155,097 June 30, December 31, 2021 2020 Cash and cash equivalents $ 203,956 $ 207,177 Restricted cash in other long-term assets 2,275 2,275 Total $ 206,231 $ 209,452 Restricted cash at June 30, 2022 represents $ 1.5 million in security deposits for the lease of the Company’s facility in San Carlos, California. The security deposit is in the form of a letter of credit secured by restricted cash . Investments The Company invests in marketable securities, primarily securities issued by the United States government and its agencies. The Company’s investments are considered available-for-sale and are classified as current assets even when the stated maturities of the underlying securities exceed one year from the date of the current balance sheet being reported. This classification reflects management’s ability and intent to utilize proceeds from the sale of such investments to fund ongoing operations. Unrealized gains and losses are excluded from earnings and are reported as a component of accumulated other comprehensive gain. The cost of securities sold is determined using the specific-identification method. Interest earned and adjustments for the amortization of premiums and discounts on investments are included in interest income, net, on the statements of operations and comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on investments in marketable securities are included in other expense, net, on the statements of operations and comprehensive loss. Going Concern Cash, cash equivalents and investments, excluding restricted cash, at June 30, 2022 totaled $ 212.4 million , compared to $ 424.2 million at December 31, 2021. Management believes that existing cash, cash equivalents and investments will be sufficient for the Company to continue as a going concern for at least 12 months from the issuance date of these unaudited interim financial statements. Management’s view regarding sufficiency of cash and liquidity is primarily based on the Company’s operating plans and financial forecast. Management’s estimates as to how long it expects the Company’s cash, cash equivalents and investments to continue to fund operations is based on assumptions that may prove to be wrong, and the Company could use its available capital resources sooner than it currently expects. Factors that may affect the Company’s capital needs include, but are not limited to: • the number, scope, and timing of clinical indications and clinical trials the Company decides to pursue; • the scope and costs of manufacturing activities; • the extent to which the Company acquires or in-licenses other product candidates and technologies, if any; • the cost, timing and outcome of regulatory review of the Company’s product candidates; • the cost and timing of establishing sales and marketing capabilities for product candidates receiving marketing approval, if any; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • the Company’s efforts to enhance operational systems and ability to attract, hire and retain qualified personnel, including personnel to support the development of the Company’s product candidates; and • the costs associated with being a public company. The Company intends to raise additional capital to support its ongoing and future clinical development and business operations. To the extent the Company raises additional funds through the sale of equity or convertible debt securities, the issuance of such securities will result in dilution to stockholders. There can be no assurance that sufficient funding will be available on favorable terms, or at all. The Company’s ability to raise additional capital may be adversely impacted by potential worsening of global economic conditions and volatility of financial markets in the United States and worldwide. If adequate funds are not available, the Company may be required to obtain funds by entering into collaboration, licensing or debt agreements on potentially unfavorable terms. If the Company is unable to raise funds on favorable terms, or at all, it may have to reduce its operating expenses and potentially delay, reduce or terminate some or all of its clinical development efforts, which would have a material adverse effect on the Company’s business, financial condition and results of operations. Operating Leases The Company accounts for its leases in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 842, “Leases” (“ASC 842”). Right-of-use assets represent the Company’s right to use an underlying asset over the lease term and include any lease payments made prior to the lease commencement date and are reduced by lease incentives. Lease liabilities represent the present value of the total lease payments over the lease term, calculated using the Company’s incremental borrowing rate. In determining the Company’s incremental borrowing rate, consideration is given to the term of the lease and the Company’s credit risk. The Company recognizes options to extend a lease when it is reasonably certain that it will exercise such extension. The Company does not recognize options to terminate a lease when it is reasonably certain that it will not exercise such early termination options. Lease expense is recognized on a straight-line basis over the expected lease term. Accrued Research and Development Expense Service agreements with contract development and manufacturing organizations (“CDMOs”), clinical contract research organizations (“CROs”) and clinical investigative sites comprise a significant component of the Company’s research and development activities. External costs for these vendors are recognized as the services are incurred. The Company accrues for expenses resulting from obligations under agreements with its third-parties for which the timing of payments does not match the periods over which the materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CDMOs, clinical CROs, clinical investigative sites and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes judgements and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CDMO, clinical CRO, clinical investigative site or other outside service provider, the payments are recorded within prepaid expenses and other current assets or other long-term assets, as appropriate, and subsequently recognized as research and development expense when the associated services have been performed. As actual costs become known, the Company adjusts its liabilities and assets. Inputs, such as the extent of services received and the duration of services to be performed, may vary from the Company’s estimates, which will result in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. The Company’s historical estimates have not been materially different from actual amounts recorded. Research and Development Expense Research and development costs are expensed as incurred. Research and development costs include, among others, consulting costs, salaries, benefits, travel, stock-based compensation, laboratory supplies and other non-capital equipment utilized for in-house research, allocation of facilities and overhead costs and external costs paid to third-parties that conduct research and development activities on the Company’s behalf. Costs to terminate commitments with third-party suppliers performing research and development activities and amounts incurred in connection with license agreements, including milestone payments, are also included in research and development expense. Advance payments for goods or services to be rendered in the future for use in research and development activities are deferred and included in prepaid expenses, and other current assets or other long-term assets, as appropriate. The deferred amounts are expensed as the related goods are delivered or the services are performed. Comprehensive Loss Comprehensive loss is defined as the change in stockholders’ equity during a period from transactions and other events and circumstances from non-owner sources. The differences between net loss and comprehensive loss for the three and six months ended June 30, 2022 and 2021 are a result of unrealized gains and losses on the Company’s investments included in current assets on the Company’s balance sheets. Net Loss per Share The Company calculates basic net loss per share by dividing the net loss attributable to common stockholders by the weighted-average shares of common stock outstanding during the period. The Company calculates diluted net loss per share after giving consideration to all potentially dilutive securities outstanding during the period using the treasury-stock and if-converted methods, except where the effect of including such securities would be anti-dilutive. Because the Company has reported net losses since inception, the effect from potentially dilutive securities would have been anti-dilutive and therefore has been excluded from the calculation of diluted net loss per share. Basic and diluted net loss per share was calculated as follows (in thousands, except per share data): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Numerator: Net loss $ ( 49,103 ) $ ( 57,209 ) $ ( 246,126 ) $ ( 112,767 ) Denominator: Weighted-average shares of common stock outstanding, 54,798 53,669 54,742 53,429 Net loss per share, basic and diluted $ ( 0.90 ) $ ( 1.07 ) $ ( 4.50 ) $ ( 2.11 ) The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect for the periods indicated (in thousands): Six Months Ended June 30, 2022 2021 Options to purchase common stock 5,543 5,826 Unvested restricted stock units 4,839 1,021 Unvested performance stock units 3,809 — Shares issuable under employee stock purchase plans 67 8 Total 14,258 6,855 Recently Issued and Adopted Accounting Pronouncements The Company has reviewed recently issued accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the Company’s financial statements as a result of future adoption. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The Company measures and reports certain financial instruments as assets and liabilities at fair value on a recurring basis. The Company’s financial assets measured at fair value on a recurring basis were as follows (in thousands): June 30, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 80,736 $ — $ — $ 80,736 Total cash equivalents 80,736 — — 80,736 Investments: U.S. treasuries 129,987 — — 129,987 Total investments 129,987 — — 129,987 Total cash equivalents $ 210,723 $ — $ — $ 210,723 December 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 150,781 $ — $ — $ 150,781 Total cash equivalents 150,781 — — 150,781 Investments: U.S. treasuries 271,416 — — 271,416 Total investments 271,416 — — 271,416 Total cash equivalents $ 422,197 $ — $ — $ 422,197 The Company evaluates transfers between levels at the end of each reporting period. There were no transfers of assets or liabilities between levels during the three and six months ended June 30, 2022 and 2021. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 4. Investments All investments were considered available-for-sale at June 30, 2022. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major security type at June 30, 2022 and December 31, 2021 are summarized in the table below (in thousands): June 30, 2022 Amortized Unrealized Unrealized Fair Available-for-sale securities: U.S. treasuries classified as investments $ 130,247 $ — $ ( 260 ) $ 129,987 Total available-for-sale securities $ 130,247 $ — $ ( 260 ) $ 129,987 December 31, 2021 Amortized Unrealized Unrealized Fair Available-for-sale securities: U.S. treasuries classified as investments $ 271,570 $ 2 $ ( 156 ) $ 271,416 Total available-for-sale securities $ 271,570 $ 2 $ ( 156 ) $ 271,416 The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. As of June 30, 2022 and December 31, 2021, the aggregate fair value of securities held by the Company in an unrealized loss position for less than twelve months was $ 130.0 million and $ 241.4 million , respectively. These securities had remaining maturities of less than one year . The Company has the intent and ability to hold such securities until recovery and has determined that there has been no material change to their credit risk. As a result, the Company determined it did not hold any investments with a credit loss at June 30, 2022 and December 31, 2021. There were no material realized gains or losses recognized on the sale or maturity of available-for-sale securities during the three and six months ended June 30, 2022 and 2021, and as a result, there were no material reclassifications out of accumulated other comprehensive gain (loss) for the same periods. |
Balance Sheet Components and Su
Balance Sheet Components and Supplemental Disclosures | 6 Months Ended |
Jun. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components and Supplemental Disclosures | 5. Balance Sheet Components and Supplemental Disclosures Property and Equipment, Net Property and equipment, net, consisted of the following (in thousands): June 30, December 31, 2022 2021 Laboratory equipment $ 6,092 $ 4,676 Furniture and office equipment 3,947 1,947 Capitalized software 4,062 — Leasehold improvements 32,458 4,581 Construction-in-progress — 37,704 46,559 48,908 Less accumulated depreciation ( 5,259 ) ( 5,808 ) Property and equipment, net $ 41,300 $ 43,100 Depreciation and amortization expense for the three months ended June 30, 2022 and 2021 was $ 1.9 million and $ 0.4 million , respectively. Depreciation and amortization expense for the six months ended June 30, 2022 and 2021 was $ 4.1 million and $ 0.7 million , respectively. Assets included within construction-in-progress primarily related to leasehold improvements and other equipment relating to our new San Carlos headquarters and were placed into service during the first quarter of 2022. Other Long-Term Assets Other long-term assets were $ 11.8 million and $ 8.4 million as of June 30, 2022 and December 31, 2021, respectively. Other long-term assets at June 30, 2022 and December 31, 2021 included $ 8.6 million and $ 5.9 million in advance payments to CDMOs for development and manufacturing services to be provided more than one year from now. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, December 31, 2022 2021 Accrued contract research and development expense $ 16,411 $ 16,215 Accrued compensation and benefits expense 4,643 3,172 Current portion of operating lease liabilities 4,145 2,316 Other current liabilities 1,439 4,854 Total $ 26,638 $ 26,557 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | 6. Leases Operating Leases The Company’s lease obligations primarily relate to leased office and laboratory space under noncancelable operating leases. In accordance with ASC 842, the Company has performed an evaluation of its other contracts with vendors and has determined that, except for the leases described below, none of its other contracts contain a material lease. 2018 Redwood City Lease In January 2018 , the Company entered into an operating lease agreement for approximately 25,000 square feet of office and laboratory space in Redwood City, California (the “2018 Redwood City Lease”). The contractual term of the 2018 Redwood City Lease was 10.75 years beginning from the substantial completion and delivery of the premises, which occurred in November 2018, and originally terminating in July 2029 . The 2018 Redwood City Lease included monthly base rent amounts escalating over the term of the lease. In addition, the lessor provided for a tenant improvement allowance (“TIA”) of up to $ 1.4 million, which was fully utilized. The TIA was recorded as leasehold improvements, with offsetting adjustments recorded to the associated operating lease right of use asset included on the Company’s balance sheets as of December 31, 2021. In November 2021 the Company entered into a lease termination agreement (the “Lease Termination Agreement”) with respect to the 2018 Redwood City Lease. Pursuant to the Lease Termination Agreement, the 2018 Redwood City Lease was terminated effective April 30, 2022 . The Company accounted for this change in lease term as a modification of the original lease. As a result of the modification, the operating right-of-use asset and lease liability were remeasured during the fourth quarter of 2021. During the second quarter of 2022, the landlord paid $ 1.1 million in connection with the early termination and upon satisfaction of all remaining conditions including the delivery of certain equipment and other assets related to the building. 2019 San Carlos Lease In December 2019 , the Company entered into an additional operating lease agreement for approximately 98,000 square feet of office and laboratory space in San Carlos, California (the “2019 San Carlos Lease”). The contractual term of the 2019 San Carlos Lease is 10.25 years from August 2021 until October 2031 . The 2019 San Carlos Lease provides rent abatements and includes a one-time option to extend the lease term for five years . This option to extend the lease term was not determined to be reasonably certain and therefore has not been included in the Company’s calculation of the associated operating lease liability under ASC 842. The 2019 San Carlos Lease includes monthly base rent amounts escalating over the term of the lease. In addition, the lessor provided for a TIA of up to $ 14.7 million, which was fully utilized and are recorded in lease obligations. The Company utilized its incremental borrowing rate to calculate the present value of the lease payments for the 2019 San Carlos Lease based on information available on November 1, 2020, the lease commencement date for accounting purposes, which was the date the Company was deemed to have obtained control of the premises. Calculation of the operating lease liability also included estimated future TIA reimbursements that had not yet been received as of the lease commencement date. TIA reimbursements received subsequent to lease commencement date are recorded as reductions to the operating lease liability. Classification of Operating Leases The 2018 Redwood City Lease and the 2019 San Carlos Lease required security deposits of $ 0.8 million and $ 1.5 million, respectively, which the Company satisfied by establishing letters of credit secured by restricted cash. Restricted cash related to the Company’s lease agreements are recorded in other long-term assets or other current assets on the Company’s balance sheets depending on the timing in which the security deposit is expected to be returned. During the second quarter of 2022 and in accordance with the lease termination, the restrictions associated with the $ 0.8 million security deposit for the 2018 Redwood City Lease was released and such funds were recorded as cash and cash equivalents as of June 30, 2022. Classification of the Company’s operating lease liabilities included on the Company's balance sheets at June 30, 2022 and December 31, 2021 was as follows (in thousands): June 30, December 31, 2022 2021 Operating lease liabilities Current portion included in accrued expenses and $ 4,145 $ 2,316 Operating lease liabilities, net of current portion 47,597 49,099 Total operating lease liabilities $ 51,742 $ 51,415 The components of lease costs included in operating expenses in the Company’s statements of operations and comprehensive loss were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, June 30, 2022 2021 2022 2021 Operating lease costs $ 1,471 $ 1,675 $ 2,925 $ 3,409 Variable costs 1,005 152 1,688 239 Total lease costs $ 2,476 $ 1,827 $ 4,613 $ 3,648 Variable costs included in the table above represent amounts the Company pays related to property taxes, insurance, maintenance and repair costs. Cash paid for amounts included in the measurement of the Company’s operating lease liabilities and presented within cash used in operating activities in the statements of cash flows was $ 3.4 million and $ 0.6 million for the six months ended June 30, 2022 and 2021, respectively. Cash received for amounts related to tenant improvement allowances from lessors was $ 1.0 million and $ 5.1 million for the six months ended June 30, 2022 and 2021, respectively. Operating Lease Obligations Future lease payments required under operating leases included on the Company’s balance sheet at June 30, 2022 are as follows (in thousands): Fiscal Year Ending December 31, 2022 (remaining 6 months) $ 4,687 2023 7,061 2024 7,273 2025 7,492 2026 7,716 Thereafter 40,679 Total future lease payments 74,908 Less: Present value adjustment 23,166 Present value of future lease incentives — Operating lease liabilities $ 51,742 Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company used its incremental borrowing rate based on the information available at the lease commencement date. As of June 30, 2022, the weighted-average remaining lease term of the Company’s leases was 9.2 years and the weighted-average discount rate used to determine the operating lease liabilities included on the balance sheet was 8.5 % . As of June 30, 2022 , the Company was not party to any lease agreements containing material residual value guarantees or material restrictive covenants. |
Contingencies
Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Loss Contingency [Abstract] | |
Contingencies | 7. Contingencies In-Licensing Agreements The Company has entered into exclusive and non-exclusive, royalty bearing license agreements with third-parties for certain intellectual property. Under the terms of the license agreements, the Company is obligated to pay milestone payments upon the achievement of specified clinical, regulatory and commercial milestones. Research and development expense associated with the Company’s milestone payments are recognized when such milestone has been achieved. Actual amounts due under the license agreements will vary depending on factors including, but not limited to, the number of products developed and the Company’s ability to further develop and commercialize the licensed products. The Company is also subject to future royalty payments based on sales of the licensed products. In-licensing payments to third-parties for milestones are recognized as research and development expense in the period of achievement. The Company did no t recognize any milestone expense for the three and six months ended June 30, 2022 and 2021. As of June 30, 2022 , the Company has no t incurred any royalty liabilities related to its license agreements, as product sales have not yet commenced. Exclusive License Agreement with The Johns Hopkins University In December 2013, the Company entered into a license agreement with The Johns Hopkins University (“JHU”) for a worldwide exclusive license to develop, use, manufacture and commercialize covered product candidates including lirentelimab, which was amended in September 2016. Under the terms of the agreement, the Company has made upfront and milestone payments of $ 0.7 million through June 30, 2022 and may be required to make aggregate additional milestone payments of up to $ 1.8 million. The Company also issued 88,887 shares of common stock as consideration under the JHU license agreement. In addition to milestone payments, the Company is also subject to low single-digit royalties to JHU based on future net sales of each licensed therapeutic product candidate by the Company and its affiliates and sublicensees, with up to a low six-digit dollar minimum annual royalty payment. Non-exclusive License Agreement with BioWa Inc. and Lonza Sales AG In October 2013, the Company entered into a tripartite agreement with BioWa Inc. (“BioWa”), and Lonza Sales AG (“Lonza Sales”), for the non-exclusive worldwide license to develop and commercialize product candidates including lirentelimab that are manufactured using a technology jointly developed and owned by BioWa and Lonza Sales. Under the terms of the agreement, the Company has made milestone payments of $ 3.4 million through June 30, 2022 and may be required to make aggregate additional milestone payments of up to $ 38.0 million. In addition to milestone payments, the Company is also subject to minimum annual commercial license fees of $ 40,000 per year to BioWa until such time as BioWa receives royalty payments, as well as low single-digit royalties to BioWa and to Lonza Sales. Royalties are based on future net sales by the Company and its affiliates and sublicensees. Indemnification Agreements The Company has entered into indemnification agreements with certain directors and officers that require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, except for the litigation described in the Legal Contingencies section below, no such matters have arisen and the Company does not believe that the outcome of any claims under indemnification arrangements will have a material adverse effect on its financial positions, results of operations or cash flows. Accordingly, the Company has not recorded a liability related to such indemnifications at June 30, 2022. Legal Contingencies On March 10, 2020, a putative securities class action complaint captioned Kim v. Allakos et al., No. 20-cv-01720 (N.D. Cal.) was filed in the United States District Court for the Northern District of California against the Company, its Chief Executive Officer, Dr. Robert Alexander, and its former Chief Financial Officer, Mr. Leo Redmond. The complaint asserts claims for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder and seeks damages based on alleged material misrepresentations and omissions concerning its Phase 2 clinical trials of lirentelimab. The proposed class period is August 5, 2019, through December 17, 2019, inclusive. On August 28, 2020, the plaintiff filed an amended complaint, adding as defendants Adam Tomasi, the Company’s President and Chief Operating Officer, and Henrik Rasmussen, the Company’s former Chief Medical Officer. On March 31, 2022, the Court granted the defendants’ motion to dismiss, with leave to amend. On April 29, 2022, the plaintiffs filed a second amended complaint which extended the proposed class period from December 17, 2019 to December 21, 2021 and added additional claims related to the Company’s Phase 3 ENIGMA clinical trial. On June 13, 2022, the defendants filed a motion to dismiss the second amended complaint. Given the early stage of this litigation matter, the Company cannot reasonably estimate a potential future loss or a range of potential future losses, if any. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Total stock-based compensation expense recognized is as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Research and development $ 4,870 $ 4,246 $ 9,305 $ 9,309 General and administrative 6,891 7,151 13,848 14,442 Total $ 11,761 $ 11,397 $ 23,153 $ 23,751 No income tax benefits for stock-based compensation expense have been recognized for the three and six months ended June 30, 2022 and 2021 as a result of the Company’s full valuation allowance applied to net deferred tax assets and net operating loss carryforwards. Equity Incentive Plans In July 2018, the Board of Directors adopted the 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units (“RSUs”), stock appreciation rights, performance units and performance shares. The number of shares of common stock that may be issued under the 2018 Plan will automatically increase on each January 1, beginning with the fiscal year ending December 31, 2019, equal to the least of (i) 5,000,000 shares, (ii) 5 % of the outstanding shares of common stock as of the last day of the preceding fiscal year or (iii) such other amount as the Board of Directors may determine. Stock options and RSUs granted under the 2018 Plan generally vest over four years and expire no more than 10 years from the date of grant. Following the IPO and upon the effectiveness of the 2018 Plan, the Company’s 2012 Equity Incentive Plan, as amended, (the “2012 Plan”), terminated and no further awards will be granted thereunder. All outstanding awards under the 2012 Plan will continue to be governed by their existing terms. Any shares subject to awards granted under the 2012 Plan that, on or after the termination of the 2012 Plan, expire or terminate and shares previously issued pursuant to awards granted under the 2012 Plan that, on or after the termination of the 2012 Plan, are forfeited or repurchased by the Company will be transferred into the 2018 Plan. As of June 30, 2022, the maximum number of shares that may be added to the 2018 Plan pursuant to the preceding sentence is 3,248,256 shares. Prior to its termination, the 2012 Plan provided for the grant of stock options, stock appreciation rights, restricted stock and restricted stock units to employees, directors and consultants. Stock options granted under the 2012 Plan generally vest over four years and expire no more than 10 years from the date of grant. Stock Options The following weighted-average assumptions were used to calculate the fair value of stock options granted during the periods indicated: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Risk-free interest rate 2.76 % 1.01 % 2.61 % 0.91 % Expected volatility 73.61 % 70.03 % 73.48 % 69.84 % Expected dividend yield — — — — Expected term (in years) 5.66 6.08 5.73 6.07 The Company’s stock option activity during the six months ended June 30, 2022 is summarized as follows (number of shares in thousands): Weighted- Average Options Exercise Outstanding Price Balance at December 31, 2021 5,530 $ 21.51 Granted 826 $ 3.53 Exercised ( 59 ) $ 2.89 Expired ( 511 ) $ 22.48 Forfeited ( 243 ) $ 64.47 Balance at June 30, 2022 5,543 $ 17.06 Options exercisable 4,379 $ 14.77 Options vested and expected to vest 5,519 $ 17.02 During the three and six months ended June 30, 2022 and 2021, the Company did no t grant any stock options with performance-based or market-based vesting conditions. As of June 30, 2022, total unrecognized stock-based compensation expense relating to unvested stock options was $ 16.4 million . This amount is expected to be recognized over a weighted-average period of 2.5 years. Restricted Stock Units (“RSUs”) RSU activity under the 2018 Plan during the six months ended June 30, 2022 is summarized as follows (in thousands, except per share data): Weighted- Average Grant Date Shares Fair Value Balance at December 31, 2021 1,506 $ 93.14 Granted 4,391 $ 5.53 Vested ( 121 ) $ 102.95 Forfeited ( 937 ) $ 52.23 Balance at June 30, 2022 4,839 $ 21.32 Th e weighted-average fair value of RSUs granted during the six months ended June 30, 2022 and 2021 was $ 5.53 and $ 107.32 , respectively. As of June 30, 2022, total unrecognized stock-based compensation expense relating to unvested RSUs was $ 91.5 million and the weighted-average remaining vesting period was 3.0 years. Performance-based Restricted Stock Units (“PSUs”) PSU activity under the 2018 Plan during the six months ended June 30, 2022 is summarized as follows (in thousands, except per share data): Weighted- Average Grant Date Shares Fair Value Balance at December 31, 2021 113 $ 79.60 Granted 4,124 $ 5.57 Forfeited ( 428 ) $ 5.58 Balance at June 30, 2022 3,809 $ 7.77 As of June 30, 2022, total unrecognized stock-based compensation expense relating to unvested PSUs was $ 29.6 million and the weighted-average remaining vesting period was 1.5 years. Employee Stock Purchase Plan In July 2018, the Company’s Board of Directors and stockholders approved the 2018 Employee Stock Purchase Plan (the “2018 ESPP”). At inception, the 2018 ESPP had a maximum number of 500,000 shares of common stock available. The number of shares of common stock that may be issued under the 2018 ESPP shall automatically increase on each January 1, beginning with the fiscal year ending December 31, 2019, equal to the least of (i) 1,000,000 shares, (ii) 1 % of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year and (iii) such other amount determined by the 2018 ESPP administrator. Under the 2018 ESPP, employees may purchase shares of the Company’s common stock at a price per share equal to 85 % of the lower of the fair market value of the common stock on the first trading day of the offering period or on the exercise date. The 2018 ESPP provides for consecutive, overlapping 24 -month offering periods, each of which will include four 6-month purchase periods. The Company’s first offering period under the 2018 ESPP commenced on July 18, 2018 . During three and six months ended June 30, 2022, stock-based compensation expense related to the 2018 ESPP was $ 0.3 million and $ 0.5 million , respectively. During the three and six months ended June 30, 2021 , stock-based compensation expense related to the 2018 ESPP was $ 0.3 million and $ 0.5 million, respectively. |
Defined Contribution Plans
Defined Contribution Plans | 6 Months Ended |
Jun. 30, 2022 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plans | 9. Defined Contribution Plans In January 2018, the Company established a defined contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) plan”). The 401(k) plan covers all employees who meet defined minimum age and service requirements. Employee contributions are voluntary and are determined on an individual basis, limited to the maximum amount allowable under U.S. federal tax regulations. The Company makes matching contributions of up to 4 % of the eligible employees’ compensation to the 401(k) plan. During the three and six months ended June 30, 2022, the Company made contributions to the 401(k) plan of $ 0.2 million and $ 0.7 million , respectively. During the three and six months ended June 30, 2021 , the Company made contributions to the 401(k) plan of $ 0.2 million and $ 0.5 million, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited interim financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”). The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes. The interim balance sheet as of June 30, 2022, the statements of operations and comprehensive loss, statements of stockholders’ equity and statements of cash flows for the six months ended June 30, 2022 and 2021 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial position as of June 30, 2022 and its results of operations and comprehensive loss for the three and six months ended June 30, 2022 and 2021 and its cash flows for the six months ended June 30, 2022 and 2021. Certain information and note disclosures normally included in annual audited financial statements prepared in accordance with U.S. GAAP have been omitted. The financial data and the other financial information disclosed in these notes to the interim financial statements are also unaudited. The results of operations for any interim period are not necessarily indicative of the results to be expected for the entire year or for any other future annual or interim period. The balance sheet as of June 30, 2022 included herein was derived from the audited financial statements as of that date. These interim financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2022. |
Use of Estimates | Use of Estimates Management uses significant judgment when making estimates related to common stock valuation and related stock-based compensation expense, accrued research and development expense, and lease-related assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates under different assumptions or conditions, and those differences could be material to the financial position and results of operations. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to credit risk principally consist of cash, cash equivalents and investments. These financial instruments are held in accounts at a single financial institution that management believes possesses high credit quality. Amounts on deposit with this financial institution have and will continue to exceed federally-insured limits. The Company has not experienced any losses on its cash deposits. Additionally, the Company’s investment policy limits its investments to certain types of securities issued by or backed by the U.S. government and its agencies. The Company is subject to a number of risks similar to that of other early stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future clinical trials, its reliance on third-parties to conduct its clinical trials, the need to obtain regulatory and marketing approvals for its product candidates, competitive developments, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, protection of proprietary technology, the ability to make milestone, royalty or other payments due under licensing agreements, and the need to secure and maintain adequate manufacturing arrangements with third-parties. If the Company does not successfully commercialize or partner its product candidates, it will be unable to generate product revenue or achieve profitability. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Company’s balance sheets and which, in aggregate, represent the amounts reported in the accompanying statements of cash flows (in thousands): June 30, December 31, 2022 2021 Cash and cash equivalents $ 82,452 $ 152,822 Restricted cash in other long-term assets 1,472 2,275 Total $ 83,924 $ 155,097 June 30, December 31, 2021 2020 Cash and cash equivalents $ 203,956 $ 207,177 Restricted cash in other long-term assets 2,275 2,275 Total $ 206,231 $ 209,452 Restricted cash at June 30, 2022 represents $ 1.5 million in security deposits for the lease of the Company’s facility in San Carlos, California. The security deposit is in the form of a letter of credit secured by restricted cash |
Investments | Investments The Company invests in marketable securities, primarily securities issued by the United States government and its agencies. The Company’s investments are considered available-for-sale and are classified as current assets even when the stated maturities of the underlying securities exceed one year from the date of the current balance sheet being reported. This classification reflects management’s ability and intent to utilize proceeds from the sale of such investments to fund ongoing operations. Unrealized gains and losses are excluded from earnings and are reported as a component of accumulated other comprehensive gain. The cost of securities sold is determined using the specific-identification method. Interest earned and adjustments for the amortization of premiums and discounts on investments are included in interest income, net, on the statements of operations and comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on investments in marketable securities are included in other expense, net, on the statements of operations and comprehensive loss. |
Going Concern | Going Concern Cash, cash equivalents and investments, excluding restricted cash, at June 30, 2022 totaled $ 212.4 million , compared to $ 424.2 million at December 31, 2021. Management believes that existing cash, cash equivalents and investments will be sufficient for the Company to continue as a going concern for at least 12 months from the issuance date of these unaudited interim financial statements. Management’s view regarding sufficiency of cash and liquidity is primarily based on the Company’s operating plans and financial forecast. Management’s estimates as to how long it expects the Company’s cash, cash equivalents and investments to continue to fund operations is based on assumptions that may prove to be wrong, and the Company could use its available capital resources sooner than it currently expects. Factors that may affect the Company’s capital needs include, but are not limited to: • the number, scope, and timing of clinical indications and clinical trials the Company decides to pursue; • the scope and costs of manufacturing activities; • the extent to which the Company acquires or in-licenses other product candidates and technologies, if any; • the cost, timing and outcome of regulatory review of the Company’s product candidates; • the cost and timing of establishing sales and marketing capabilities for product candidates receiving marketing approval, if any; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • the Company’s efforts to enhance operational systems and ability to attract, hire and retain qualified personnel, including personnel to support the development of the Company’s product candidates; and • the costs associated with being a public company. The Company intends to raise additional capital to support its ongoing and future clinical development and business operations. To the extent the Company raises additional funds through the sale of equity or convertible debt securities, the issuance of such securities will result in dilution to stockholders. There can be no assurance that sufficient funding will be available on favorable terms, or at all. The Company’s ability to raise additional capital may be adversely impacted by potential worsening of global economic conditions and volatility of financial markets in the United States and worldwide. If adequate funds are not available, the Company may be required to obtain funds by entering into collaboration, licensing or debt agreements on potentially unfavorable terms. If the Company is unable to raise funds on favorable terms, or at all, it may have to reduce its operating expenses and potentially delay, reduce or terminate some or all of its clinical development efforts, which would have a material adverse effect on the Company’s business, financial condition and results of operations. |
Operating Leases | Operating Leases The Company accounts for its leases in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 842, “Leases” (“ASC 842”). Right-of-use assets represent the Company’s right to use an underlying asset over the lease term and include any lease payments made prior to the lease commencement date and are reduced by lease incentives. Lease liabilities represent the present value of the total lease payments over the lease term, calculated using the Company’s incremental borrowing rate. In determining the Company’s incremental borrowing rate, consideration is given to the term of the lease and the Company’s credit risk. The Company recognizes options to extend a lease when it is reasonably certain that it will exercise such extension. The Company does not recognize options to terminate a lease when it is reasonably certain that it will not exercise such early termination options. Lease expense is recognized on a straight-line basis over the expected lease term. |
Accrued Research and Development Expense | Accrued Research and Development Expense Service agreements with contract development and manufacturing organizations (“CDMOs”), clinical contract research organizations (“CROs”) and clinical investigative sites comprise a significant component of the Company’s research and development activities. External costs for these vendors are recognized as the services are incurred. The Company accrues for expenses resulting from obligations under agreements with its third-parties for which the timing of payments does not match the periods over which the materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CDMOs, clinical CROs, clinical investigative sites and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes judgements and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CDMO, clinical CRO, clinical investigative site or other outside service provider, the payments are recorded within prepaid expenses and other current assets or other long-term assets, as appropriate, and subsequently recognized as research and development expense when the associated services have been performed. As actual costs become known, the Company adjusts its liabilities and assets. Inputs, such as the extent of services received and the duration of services to be performed, may vary from the Company’s estimates, which will result in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. The Company’s historical estimates have not been materially different from actual amounts recorded. |
Research and Development Expense | Research and Development Expense Research and development costs are expensed as incurred. Research and development costs include, among others, consulting costs, salaries, benefits, travel, stock-based compensation, laboratory supplies and other non-capital equipment utilized for in-house research, allocation of facilities and overhead costs and external costs paid to third-parties that conduct research and development activities on the Company’s behalf. Costs to terminate commitments with third-party suppliers performing research and development activities and amounts incurred in connection with license agreements, including milestone payments, are also included in research and development expense. Advance payments for goods or services to be rendered in the future for use in research and development activities are deferred and included in prepaid expenses, and other current assets or other long-term assets, as appropriate. The deferred amounts are expensed as the related goods are delivered or the services are performed. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in stockholders’ equity during a period from transactions and other events and circumstances from non-owner sources. The differences between net loss and comprehensive loss for the three and six months ended June 30, 2022 and 2021 are a result of unrealized gains and losses on the Company’s investments included in current assets on the Company’s balance sheets. |
Net Loss per Share | Net Loss per Share The Company calculates basic net loss per share by dividing the net loss attributable to common stockholders by the weighted-average shares of common stock outstanding during the period. The Company calculates diluted net loss per share after giving consideration to all potentially dilutive securities outstanding during the period using the treasury-stock and if-converted methods, except where the effect of including such securities would be anti-dilutive. Because the Company has reported net losses since inception, the effect from potentially dilutive securities would have been anti-dilutive and therefore has been excluded from the calculation of diluted net loss per share. Basic and diluted net loss per share was calculated as follows (in thousands, except per share data): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Numerator: Net loss $ ( 49,103 ) $ ( 57,209 ) $ ( 246,126 ) $ ( 112,767 ) Denominator: Weighted-average shares of common stock outstanding, 54,798 53,669 54,742 53,429 Net loss per share, basic and diluted $ ( 0.90 ) $ ( 1.07 ) $ ( 4.50 ) $ ( 2.11 ) The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect for the periods indicated (in thousands): Six Months Ended June 30, 2022 2021 Options to purchase common stock 5,543 5,826 Unvested restricted stock units 4,839 1,021 Unvested performance stock units 3,809 — Shares issuable under employee stock purchase plans 67 8 Total 14,258 6,855 |
Recently Issued and Adopted Accounting Pronouncements | Recently Issued and Adopted Accounting Pronouncements The Company has reviewed recently issued accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the Company’s financial statements as a result of future adoption. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Company’s balance sheets and which, in aggregate, represent the amounts reported in the accompanying statements of cash flows (in thousands): June 30, December 31, 2022 2021 Cash and cash equivalents $ 82,452 $ 152,822 Restricted cash in other long-term assets 1,472 2,275 Total $ 83,924 $ 155,097 June 30, December 31, 2021 2020 Cash and cash equivalents $ 203,956 $ 207,177 Restricted cash in other long-term assets 2,275 2,275 Total $ 206,231 $ 209,452 |
Calculation of Basic and Diluted Net Loss per Share | Basic and diluted net loss per share was calculated as follows (in thousands, except per share data): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Numerator: Net loss $ ( 49,103 ) $ ( 57,209 ) $ ( 246,126 ) $ ( 112,767 ) Denominator: Weighted-average shares of common stock outstanding, 54,798 53,669 54,742 53,429 Net loss per share, basic and diluted $ ( 0.90 ) $ ( 1.07 ) $ ( 4.50 ) $ ( 2.11 ) |
Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss per Share | The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect for the periods indicated (in thousands): Six Months Ended June 30, 2022 2021 Options to purchase common stock 5,543 5,826 Unvested restricted stock units 4,839 1,021 Unvested performance stock units 3,809 — Shares issuable under employee stock purchase plans 67 8 Total 14,258 6,855 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | The Company’s financial assets measured at fair value on a recurring basis were as follows (in thousands): June 30, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 80,736 $ — $ — $ 80,736 Total cash equivalents 80,736 — — 80,736 Investments: U.S. treasuries 129,987 — — 129,987 Total investments 129,987 — — 129,987 Total cash equivalents $ 210,723 $ — $ — $ 210,723 December 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 150,781 $ — $ — $ 150,781 Total cash equivalents 150,781 — — 150,781 Investments: U.S. treasuries 271,416 — — 271,416 Total investments 271,416 — — 271,416 Total cash equivalents $ 422,197 $ — $ — $ 422,197 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Investments | All investments were considered available-for-sale at June 30, 2022. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major security type at June 30, 2022 and December 31, 2021 are summarized in the table below (in thousands): June 30, 2022 Amortized Unrealized Unrealized Fair Available-for-sale securities: U.S. treasuries classified as investments $ 130,247 $ — $ ( 260 ) $ 129,987 Total available-for-sale securities $ 130,247 $ — $ ( 260 ) $ 129,987 December 31, 2021 Amortized Unrealized Unrealized Fair Available-for-sale securities: U.S. treasuries classified as investments $ 271,570 $ 2 $ ( 156 ) $ 271,416 Total available-for-sale securities $ 271,570 $ 2 $ ( 156 ) $ 271,416 |
Balance Sheet Components and _2
Balance Sheet Components and Supplemental Disclosures (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net, consisted of the following (in thousands): June 30, December 31, 2022 2021 Laboratory equipment $ 6,092 $ 4,676 Furniture and office equipment 3,947 1,947 Capitalized software 4,062 — Leasehold improvements 32,458 4,581 Construction-in-progress — 37,704 46,559 48,908 Less accumulated depreciation ( 5,259 ) ( 5,808 ) Property and equipment, net $ 41,300 $ 43,100 |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, December 31, 2022 2021 Accrued contract research and development expense $ 16,411 $ 16,215 Accrued compensation and benefits expense 4,643 3,172 Current portion of operating lease liabilities 4,145 2,316 Other current liabilities 1,439 4,854 Total $ 26,638 $ 26,557 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Summary of Classification of Company's Operating Lease Liabilities | Classification of the Company’s operating lease liabilities included on the Company's balance sheets at June 30, 2022 and December 31, 2021 was as follows (in thousands): June 30, December 31, 2022 2021 Operating lease liabilities Current portion included in accrued expenses and $ 4,145 $ 2,316 Operating lease liabilities, net of current portion 47,597 49,099 Total operating lease liabilities $ 51,742 $ 51,415 |
Summary of Components of Lease Costs | The components of lease costs included in operating expenses in the Company’s statements of operations and comprehensive loss were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, June 30, 2022 2021 2022 2021 Operating lease costs $ 1,471 $ 1,675 $ 2,925 $ 3,409 Variable costs 1,005 152 1,688 239 Total lease costs $ 2,476 $ 1,827 $ 4,613 $ 3,648 |
Summary of Future Lease Payments Required Under Operating Leases | Future lease payments required under operating leases included on the Company’s balance sheet at June 30, 2022 are as follows (in thousands): Fiscal Year Ending December 31, 2022 (remaining 6 months) $ 4,687 2023 7,061 2024 7,273 2025 7,492 2026 7,716 Thereafter 40,679 Total future lease payments 74,908 Less: Present value adjustment 23,166 Present value of future lease incentives — Operating lease liabilities $ 51,742 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Summary of Total Stock-Based Compensation Expense Recognized | Total stock-based compensation expense recognized is as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Research and development $ 4,870 $ 4,246 $ 9,305 $ 9,309 General and administrative 6,891 7,151 13,848 14,442 Total $ 11,761 $ 11,397 $ 23,153 $ 23,751 |
Summary of Weighted-Average Assumptions Used to Calculate Fair Value of Stock Options Granted | The following weighted-average assumptions were used to calculate the fair value of stock options granted during the periods indicated: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Risk-free interest rate 2.76 % 1.01 % 2.61 % 0.91 % Expected volatility 73.61 % 70.03 % 73.48 % 69.84 % Expected dividend yield — — — — Expected term (in years) 5.66 6.08 5.73 6.07 |
Summary of Stock Option Activity | The Company’s stock option activity during the six months ended June 30, 2022 is summarized as follows (number of shares in thousands): Weighted- Average Options Exercise Outstanding Price Balance at December 31, 2021 5,530 $ 21.51 Granted 826 $ 3.53 Exercised ( 59 ) $ 2.89 Expired ( 511 ) $ 22.48 Forfeited ( 243 ) $ 64.47 Balance at June 30, 2022 5,543 $ 17.06 Options exercisable 4,379 $ 14.77 Options vested and expected to vest 5,519 $ 17.02 |
Restricted Stock Units | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Summary of Restricted Stock Units | RSU activity under the 2018 Plan during the six months ended June 30, 2022 is summarized as follows (in thousands, except per share data): Weighted- Average Grant Date Shares Fair Value Balance at December 31, 2021 1,506 $ 93.14 Granted 4,391 $ 5.53 Vested ( 121 ) $ 102.95 Forfeited ( 937 ) $ 52.23 Balance at June 30, 2022 4,839 $ 21.32 Th |
Performance based restricted stock units member | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Summary of Restricted Stock Units | PSU activity under the 2018 Plan during the six months ended June 30, 2022 is summarized as follows (in thousands, except per share data): Weighted- Average Grant Date Shares Fair Value Balance at December 31, 2021 113 $ 79.60 Granted 4,124 $ 5.57 Forfeited ( 428 ) $ 5.58 Balance at June 30, 2022 3,809 $ 7.77 |
Organization and Business - Add
Organization and Business - Additional Information (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Jun. 30, 2022 USD ($) Segment | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||
Number of reportable segments | Segment | 1 | ||||||
Net loss | $ 49,103 | $ 197,023 | $ 57,209 | $ 55,558 | $ 246,126 | $ 112,767 | |
Cash used in operations | 207,057 | $ 96,041 | |||||
Accumulated deficit | $ 858,950 | $ 858,950 | $ 612,824 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 82,452 | $ 152,822 | $ 203,956 | $ 207,177 |
Restricted cash in other long-term assets | 1,472 | 2,275 | 2,275 | 2,275 |
Total | $ 83,924 | $ 155,097 | $ 206,231 | $ 209,452 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Restricted cash in other long term assets, deposit for lease facility | $ 1,472 | $ 2,275 | $ 2,275 | $ 2,275 |
Cash, cash equivalents and marketable securities | $ 212,400 | $ 424,200 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Calculation of Basic and Diluted Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Numerator: | ||||||
Net loss | $ (49,103) | $ (197,023) | $ (57,209) | $ (55,558) | $ (246,126) | $ (112,767) |
Denominator: | ||||||
Weighted-average shares of common stock outstanding, basic | 54,798,000 | 53,669,000 | 54,742,000 | 53,429,000 | ||
Weighted-average shares of common stock outstanding, diluted | 54,798,000 | 53,669,000 | 54,742,000 | 53,429,000 | ||
Net loss per share, basic | $ (0.90) | $ (1.07) | $ (4.50) | $ (2.11) | ||
Net loss per share, diluted | $ (0.90) | $ (1.07) | $ (4.50) | $ (2.11) |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss per Share (Details) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share due to anti-dilutive effect | 14,258 | 6,855 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share due to anti-dilutive effect | 5,543 | 5,826 |
Unvested Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share due to anti-dilutive effect | 4,839 | 1,021 |
Unvested Performance Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share due to anti-dilutive effect | 3,809 | 0 |
Shares Issuable under Employee Stock Purchase Plans | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation of diluted net loss per share due to anti-dilutive effect | 67 | 8 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | $ 129,987 | $ 271,416 |
Fair Value, Measurements, Recurring Basis | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 80,736 | 150,781 |
Fair Value | 129,987 | 271,416 |
Total cash equivalents and investments | 210,723 | 422,197 |
Fair Value, Measurements, Recurring Basis | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 80,736 | 150,781 |
Fair Value | 129,987 | 271,416 |
Total cash equivalents and investments | 210,723 | 422,197 |
Fair Value, Measurements, Recurring Basis | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Fair Value | 0 | 0 |
Total cash equivalents and investments | 0 | 0 |
Fair Value, Measurements, Recurring Basis | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Fair Value | 0 | 0 |
Total cash equivalents and investments | 0 | 0 |
Fair Value, Measurements, Recurring Basis | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 80,736 | 150,781 |
Fair Value, Measurements, Recurring Basis | Money Market Funds | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 80,736 | 150,781 |
Fair Value, Measurements, Recurring Basis | Money Market Funds | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Fair Value, Measurements, Recurring Basis | Money Market Funds | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Fair Value, Measurements, Recurring Basis | U.S. Treasuries | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 129,987 | 271,416 |
Fair Value, Measurements, Recurring Basis | U.S. Treasuries | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 129,987 | 271,416 |
Fair Value, Measurements, Recurring Basis | U.S. Treasuries | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring Basis | U.S. Treasuries | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | ||||
Transfers of assets between level 1 to level 2 | $ 0 | $ 0 | $ 0 | $ 0 |
Transfers of assets between level 2 to level 1 | 0 | 0 | 0 | 0 |
Transfers of liabilities between level 1 to level 2 | 0 | 0 | 0 | 0 |
Transfers of liabilities between level 2 to level 1 | 0 | 0 | 0 | 0 |
Transfers of assets into level 3 | 0 | 0 | 0 | 0 |
Transfers of assets out of level 3 | 0 | 0 | 0 | 0 |
Transfers of liabilities into level 3 | 0 | 0 | 0 | 0 |
Transfers of liabilities out of level 3 | $ 0 | $ 0 | $ 0 | $ 0 |
Investments - Summary of Amorti
Investments - Summary of Amortized Cost, Gross Unrealized Holding Gains or Losses, and Fair Value of Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost Basis | $ 130,247 | $ 271,570 |
Unrealized Gains | 0 | 2 |
Unrealized Losses | (260) | (156) |
Fair Value | 129,987 | 271,416 |
Investments | U.S. Treasuries | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost Basis | 130,247 | 271,570 |
Unrealized Gains | 0 | 2 |
Unrealized Losses | (260) | (156) |
Fair Value | $ 129,987 | $ 271,416 |
Investments - Additional Inform
Investments - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Schedule Of Available For Sale Securities [Line Items] | |||||
Available-for-sale securities in an unrealized loss position, fair value | $ 130,000,000 | $ 130,000,000 | $ 241,400,000 | ||
Available-for-sale securities gross recognized losses on sale or maturity | $ 0 | $ 0 | $ 0 | $ 0 | |
Maximum | |||||
Schedule Of Available For Sale Securities [Line Items] | |||||
Available-for-sale securities, remaining maturity period | 1 year | 1 year | 1 year |
Balance Sheet Components and _3
Balance Sheet Components and Supplemental Disclosures - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 46,559 | $ 48,908 |
Less accumulated depreciation | (5,259) | (5,808) |
Property and equipment, net | 41,300 | 43,100 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,092 | 4,676 |
Furniture And Office Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 3,947 | 1,947 |
Capitalized Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 4,062 | 0 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 32,458 | 4,581 |
Construction In Progress | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 0 | $ 37,704 |
Balance Sheet Components and _4
Balance Sheet Components and Supplemental Disclosures - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Balance Sheet Related Disclosures [Line Items] | |||||
Depreciation and amortization | $ 1,900 | $ 400 | $ 4,064 | $ 747 | |
Other long-term assets | $ 11,781 | 11,781 | $ 8,436 | ||
Other Long-Term Assets | |||||
Balance Sheet Related Disclosures [Line Items] | |||||
Advance payments to CDMOs for development and manufacturing services | $ 8,600 | $ 5,900 |
Balance Sheet Components and _5
Balance Sheet Components and Supplemental Disclosures - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued contract research and development expense | $ 16,411 | $ 16,215 |
Accrued compensation and benefits expense | 4,643 | 3,172 |
Current portion of operating lease liabilities | 4,145 | 2,316 |
Other current liabilities | 1,439 | 4,854 |
Total | $ 26,638 | $ 26,557 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 1 Months Ended | 6 Months Ended | ||||
Nov. 30, 2021 | Dec. 31, 2019 USD ($) ft² | Jan. 31, 2018 USD ($) ft² | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||||
Remaining lease liability | $ 47,597 | $ 49,099 | ||||
Remaining right-of-use assets | 31,962 | $ 31,707 | ||||
Cash paid for amounts included in measurement of operating lease liabilities | 3,400 | $ 600 | ||||
Cash received for amounts related to tenant improvement allowances from lessors | $ 1,000 | $ 5,100 | ||||
Operating lease, weighted-average remaining lease term | 9 years 2 months 12 days | |||||
Operating lease, weighted-average discount rate | 8.50% | |||||
2019 San Carlos Lease Agreement | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Operating lease agreement initiation period | 2019-12 | |||||
Base term of lease | 10 years 3 months | |||||
Lessee operating lease expected termination Period | 2031-10 | |||||
Lease term extension period | 5 years | |||||
Area of office and laboratory space | ft² | 98,000 | |||||
Security deposit in the form of letter of credit secured by restricted cash | $ 1,500 | |||||
2019 San Carlos Lease Agreement | Maximum | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Tenant improvement allowance | $ 14,700 | |||||
2018 Redwood City Lease Agreement | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Operating lease agreement initiation period | 2018-01 | |||||
Base term of lease | 10 years 9 months | |||||
Lease termination date | 2021-11 | |||||
Lessee operating lease expected termination Period | 2029-07 | |||||
Area of office and laboratory space | ft² | 25,000 | |||||
Tenant improvement allowance | $ 1,400 | |||||
Early lease termination payment receivable | $ 1,100 | |||||
Security deposit in the form of letter of credit secured by restricted cash | $ 800 | |||||
2018 Redwood City Lease Agreement | Lease Termination Agreement | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Lease termination date | Apr. 30, 2022 |
Leases - Summary of Classificat
Leases - Summary of Classification of Company's Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Operating lease liabilities | ||
Current portion included in accrued expenses and other current liabilities | $ 4,145 | $ 2,316 |
Operating lease liabilities, net of current portion | 47,597 | 49,099 |
Total operating lease liabilities | $ 51,742 | $ 51,415 |
Leases - Summary of Components
Leases - Summary of Components of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | ||||
Operating lease cost | $ 1,471 | $ 1,675 | $ 2,925 | $ 3,409 |
Variable cost | 1,005 | 152 | 1,688 | 239 |
Total lease costs | $ 2,476 | $ 1,827 | $ 4,613 | $ 3,648 |
Leases - Summary of Future Leas
Leases - Summary of Future Lease Payments Required Under Operating Leases (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | ||
2022 (remaining 6 months) | $ 4,687 | |
2023 | 7,061 | |
2024 | 7,273 | |
2025 | 7,492 | |
2026 | 7,716 | |
Thereafter | 40,679 | |
Total future lease payments | 74,908 | |
Present value adjustment | 23,166 | |
Present value of future lease incentives | 0 | |
Operating lease liabilities | $ 51,742 | $ 51,415 |
Contingencies - Additional Info
Contingencies - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 99 Months Ended | 102 Months Ended | 105 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2022 | Jun. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Loss Contingencies [Line Items] | ||||||||
Accrued Royalties | $ 0 | $ 0 | $ 0 | $ 0 | ||||
Common stock, shares issued | 54,844,000 | 54,844,000 | 54,844,000 | 54,844,000 | 54,622,000 | |||
In-Licensing Agreements | ||||||||
Loss Contingencies [Line Items] | ||||||||
Milestone expense | $ 0 | $ 0 | $ 0 | $ 0 | ||||
Exclusive License Agreement with The Johns Hopkins University | ||||||||
Loss Contingencies [Line Items] | ||||||||
Upfront and milestone payments | $ 700,000 | |||||||
Common stock, shares issued | 88,887 | 88,887 | 88,887 | 88,887 | ||||
Non-exclusive License Agreement with BioWa Inc. and Lonza Sales AG | ||||||||
Loss Contingencies [Line Items] | ||||||||
Milestone payments | $ 3,400,000 | |||||||
Minimum | Non-exclusive License Agreement with BioWa Inc. and Lonza Sales AG | ||||||||
Loss Contingencies [Line Items] | ||||||||
Annual commercial license fees | 40,000 | |||||||
Maximum | Exclusive License Agreement with The Johns Hopkins University | ||||||||
Loss Contingencies [Line Items] | ||||||||
Aggregate additional milestone payments | $ 1,800,000 | |||||||
Maximum | Non-exclusive License Agreement with BioWa Inc. and Lonza Sales AG | ||||||||
Loss Contingencies [Line Items] | ||||||||
Aggregate additional milestone payments | $ 38,000,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Total Stock-Based Compensation Expense Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 11,761 | $ 11,397 | $ 23,153 | $ 23,751 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 4,870 | 4,246 | 9,305 | 9,309 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 6,891 | $ 7,151 | $ 13,848 | $ 14,442 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jul. 31, 2018 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Tax benefits for stock-based compensation expense recognized | $ 0 | $ 0 | $ 0 | $ 0 | ||
Stock options granted | 826,000 | |||||
Total unrecognized stock-based compensation expense relating to unvested stock options | $ 16,400 | 16,400 | $ 16,400 | |||
Weighted-average recognition period | 2 years 6 months | |||||
Total stock-based compensation expense | $ 11,761 | $ 11,397 | $ 23,153 | $ 23,751 | ||
Performance-Based Vesting | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options granted | 0 | 0 | 0 | 0 | ||
Market-Based Vesting | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options granted | 0 | 0 | 0 | 0 | ||
Restricted Stock Units | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 3 years | |||||
Weighted-average fair value of RSUs granted | $ 5.53 | $ 107.32 | ||||
Total unrecognized stock-based compensation expense | $ 91,500 | $ 91,500 | $ 91,500 | |||
2018 Employee Stock Purchase Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Increase in number of common stock shares reserved for issuance per year | 1,000,000 | |||||
Percentage increase in shares reserved for issuance per year | 1% | |||||
Price as a percentage of fair market value of common stock | 85% | |||||
Consecutive overlapping offering period | 24 months | |||||
First offering period commence date | Jul. 18, 2018 | |||||
Total stock-based compensation expense | 300 | $ 300 | $ 500 | $ 500 | ||
2018 Employee Stock Purchase Plan | Common Stock | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Maximum number of additional shares authorized to be added to the Plan | 500,000 | |||||
Performance based restricted stock units member | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 1 year 6 months | |||||
Weighted-average fair value of RSUs granted | $ 5.57 | |||||
Total unrecognized stock-based compensation expense | $ 29,600 | $ 29,600 | $ 29,600 | |||
2018 Equity Incentive Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Increase in number of common stock shares reserved for issuance per year | 5,000,000 | |||||
Percentage increase in shares reserved for issuance per year | 5% | |||||
Vesting period | 4 years | |||||
Maximum number of additional shares authorized to be added to the Plan | 3,248,256 | |||||
2018 Equity Incentive Plan | Maximum | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Option expiration period | 10 years |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Weighted-Average Assumptions Used to Calculate Fair Value of Stock Options Granted (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk-free interest rate | 2.76% | 1.01% | 2.61% | 0.91% |
Expected volatility | 73.61% | 70.03% | 73.48% | 69.84% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Expected term (in years) | 5 years 7 months 28 days | 6 years 29 days | 5 years 8 months 23 days | 6 years 25 days |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Activity (Details) - $ / shares shares in Thousands | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Options Outstanding, Beginning balance | 5,530 |
Options Outstanding, Granted | 826 |
Options Outstanding, Exercised | (59) |
Options outstanding, Expired | (511) |
Options Outstanding, forfeited | (243) |
Options Outstanding, Ending balance | 5,543 |
Options Outstanding, Options exercisable | 4,379 |
Options Outstanding, Options vested and expected to vest | 5,519 |
Weighted Average Exercise Price, Beginning balance | $ 21.51 |
Weighted Average Exercise Price, Granted | 3.53 |
Weighted Average Exercise Price, Exercised | 2.89 |
Weighted Average Exercise Price, Expired | 22.48 |
Weighted Average Exercise Price, Forfeited | 64.47 |
Weighted Average Exercise Price, Ending balance | 17.06 |
Weighted Average Exercise Price, Options exercisable | 14.77 |
Weighted Average Exercise Price, Options vested and expected to vest | $ 17.02 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of RSU Activity Under 2018 Plan (Details) - $ / shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Restricted Stock Units | ||
Number of Shares | ||
Balance at December 31, 2021 | 1,506 | |
Granted | 4,391 | |
Vested | (121) | |
Forfeited | (937) | |
Balance at June 30, 2022 | 4,839 | |
Weighted-Average Grant Date Fair Value | ||
Balance at December 31, 2021 | $ 93.14 | |
Granted | 5.53 | $ 107.32 |
Vested | 102.95 | |
Forfeited | 52.23 | |
Balance at June 30, 2022 | $ 21.32 | |
Performance based restricted stock units member | ||
Number of Shares | ||
Balance at December 31, 2021 | 113 | |
Granted | 4,124 | |
Forfeited | (428) | |
Balance at June 30, 2022 | 3,809 | |
Weighted-Average Grant Date Fair Value | ||
Balance at December 31, 2021 | $ 79.60 | |
Granted | 5.57 | |
Forfeited | 5.58 | |
Balance at June 30, 2022 | $ 7.77 |
Defined Contribution Plans - Ad
Defined Contribution Plans - Additional Information (Details) - 401(K) Plan - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Defined Contribution Plan Disclosure [Line Items] | ||||
Employer contribution matching percentage | 4% | 4% | ||
Contributions made by employer | $ 0.2 | $ 0.2 | $ 0.7 | $ 0.5 |