Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Jan. 31, 2022 | Jun. 30, 2021 | |
Document and Entity Information | |||
Auditor Name | PricewaterhouseCoopers LLP | ||
Auditor Firm ID | 238 | ||
Auditor Location | Boston, Massachusetts | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Entity File Number | 001-38586 | ||
Entity Registrant Name | RUBIUS THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-2688109 | ||
Entity Address, Address Line One | 399 Binney Street | ||
Entity Address, Address Line Two | Suite 300 | ||
Entity Address, City or Town | Cambridge | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02139 | ||
City Area Code | 617 | ||
Local Phone Number | 679-9600 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | RUBY | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Common Stock, Shares Outstanding | 90,080,520 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001709401 | ||
Amendment Flag | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 851.6 | ||
Entity Voluntary Filers | No |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 225,848 | $ 91,165 |
Investments | 0 | 85,122 |
Prepaid expenses and other current assets | 3,975 | 5,224 |
Total current assets | 229,823 | 181,511 |
Operating lease, right-of-use-asset | 35,095 | 40,447 |
Property, plant and equipment, net | 51,530 | 53,952 |
Restricted cash | 1,573 | 1,573 |
Other assets | 311 | |
Total assets | 318,021 | 277,794 |
Current liabilities: | ||
Accounts payable | 11,572 | 5,478 |
Accrued expenses and other current liabilities | 14,072 | 13,417 |
Operating lease liabilities | 9,015 | 8,945 |
Total current liabilities | 34,659 | 27,840 |
Long-term debt, net of discount | 76,154 | 74,944 |
Other long-term liabilities | 135 | 688 |
Operating lease liabilities, net of current portion | 28,291 | 32,762 |
Total liabilities | 139,239 | 136,234 |
Commitments and contingencies (see Note 10) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2021 and December 31, 2020; no shares issued or outstanding at December 31, 2021 and December 31, 2020 | ||
Common stock, $0.001 par value; 150,000,000 shares authorized at December 31, 2021 and December 31, 2020; 90,063,770 and 81,053,651 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively | 90 | 81 |
Additional paid-in capital | 855,710 | 621,946 |
Accumulated other comprehensive income | 4 | |
Accumulated deficit | (677,018) | (480,471) |
Total stockholders' equity | 178,782 | 141,560 |
Total liabilities and stockholders' equity | $ 318,021 | $ 277,794 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, share authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, share authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 90,063,770 | 81,053,651 |
Common stock, shares outstanding (in shares) | 90,063,770 | 81,053,651 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating expenses: | |||
Research and development | $ 141,587 | $ 116,107 | $ 112,419 |
General and administrative | 53,029 | 50,341 | 57,182 |
Total operating expenses | 194,616 | 166,448 | 169,601 |
Loss from operations | (194,616) | (166,448) | (169,601) |
Other income (expense): | |||
Interest income | 91 | 1,760 | 7,994 |
Interest expense | (6,434) | (4,185) | (2,590) |
Other income, net | 4,412 | 1,142 | 739 |
Total other income (expense), net | (1,931) | (1,283) | 6,143 |
Net loss | (196,547) | (167,731) | (163,458) |
Comprehensive loss: | |||
Net loss | (196,547) | (167,731) | (163,458) |
Other comprehensive income (loss): | |||
Unrealized (losses) on investments, net of tax of $0 | (4) | (71) | 104 |
Comprehensive loss | $ (196,551) | $ (167,802) | $ (163,354) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||
Unrealized gains (losses) on investments, tax | $ 0 | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS STOCKHOLDERS EQUITY - USD ($) $ in Thousands | Common stock | Additional paid-in capital | Accumulated other comprehensive income | Accumulated deficitAdjustments | Accumulated deficit | Adjustments | Total |
Balances at Beginning of period (in shares) at Dec. 31, 2018 | 79,234,853 | ||||||
Balances at Beginning of period at Dec. 31, 2018 | $ 79 | $ 543,040 | $ (29) | $ (150,082) | $ 393,008 | ||
Issuance of common stock from public offering, net of commissions, underwriting discounts and offering costs of $800 | $ 2 | 2,443 | 2,445 | ||||
Issuance of common stock from public offering, net of commissions, underwriting discounts and offering costs (in shares) | 1,449,309 | ||||||
Stock-based compensation expense | 41,271 | 41,271 | |||||
Repurchase of unvested restricted common stock | $ (1) | (1) | |||||
Repurchase of unvested restricted common stock (in shares) | (667,917) | ||||||
Vesting of restricted common stock | 44 | 44 | |||||
Unrealized gains (losses) on investments | 104 | 104 | |||||
Net loss | (163,458) | (163,458) | |||||
Balances at End of period (in shares) at Dec. 31, 2019 | 80,016,245 | ||||||
Balances at End of period at Dec. 31, 2019 | $ 80 | 586,798 | 75 | $ 800 | (312,740) | $ 800 | 274,213 |
Issuance of common stock upon exercise of stock options | $ 1 | 1,483 | 1,484 | ||||
Issuance of common stock upon exercise of stock options (in shares) | 1,037,406 | ||||||
Stock-based compensation expense | 33,665 | 33,665 | |||||
Unrealized gains (losses) on investments | (71) | (71) | |||||
Net loss | (167,731) | (167,731) | |||||
Balances at End of period (in shares) at Dec. 31, 2020 | 81,053,651 | ||||||
Balances at End of period at Dec. 31, 2020 | $ 81 | 621,946 | 4 | (480,471) | 141,560 | ||
Issuance of common stock from public offering, net of commissions, underwriting discounts and offering costs of $800 | $ 7 | 187,193 | 187,200 | ||||
Issuance of common stock from public offering, net of commissions, underwriting discounts and offering costs (in shares) | 6,896,552 | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,933,523 | ||||||
Issuance of common stock under employee stock purchase plan | 278 | 278 | |||||
Issuance of common stock under employee stock purchase plan (in shares) | 26,444 | ||||||
Vesting of restricted stock units | 153,600 | ||||||
Issuance of restricted common stock upon early exercise of stock options | $ 2 | 10,683 | 10,685 | ||||
Stock-based compensation expense | 35,610 | 35,610 | |||||
Unrealized gains (losses) on investments | $ (4) | (4) | |||||
Net loss | (196,547) | (196,547) | |||||
Balances at End of period (in shares) at Dec. 31, 2021 | 90,063,770 | ||||||
Balances at End of period at Dec. 31, 2021 | $ 90 | $ 855,710 | $ (677,018) | $ 178,782 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS STOCKHOLDERS EQUITY (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY | |
Net of commissions, underwriting discounts and offering costs | $ 800 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | |||
Net loss | $ (196,547) | $ (167,731) | $ (163,458) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 35,610 | 33,665 | 41,271 |
Depreciation and amortization expense | 7,723 | 5,691 | 2,995 |
Amortization (accretion) of premium (discount) on investments | 118 | 266 | (2,320) |
Loss on disposal of property and equipment | 335 | ||
Non-cash interest expense | 1,280 | 349 | 289 |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | 1,249 | 992 | 2,655 |
Operating lease, right-of-use-asset | 5,352 | 5,539 | 4,991 |
Other assets | 5 | 46 | 2 |
Accounts payable | 5,858 | (1,369) | (1,037) |
Accrued expenses and other current liabilities | (816) | (96) | 6,107 |
Other long-term liabilities | (553) | 283 | 396 |
Operating lease liabilities | (4,401) | (5,283) | (2,670) |
Net cash used in operating activities | (145,122) | (127,648) | (110,444) |
Cash flows from investing activities: | |||
Purchases of property, plant and equipment | (3,649) | (5,497) | (40,657) |
Purchases of investments | (122,671) | (319,133) | |
Sales and maturities of investments | 85,000 | 228,600 | 227,155 |
Net cash provided by (used in) investing activities | 81,351 | 100,432 | (132,635) |
Cash flows from financing activities: | |||
Proceeds from underwritten public offering of common stock, net of commissions and underwriting discounts | 188,000 | ||
Payments of offering costs | (360) | ||
Payments of debt issuance costs | (150) | ||
Repurchase of unvested restricted common stock | (122) | ||
Proceeds from borrowings under loan and security agreement | 25,000 | 25,000 | |
Proceeds from issuance of common stock upon exercise of stock options | 10,963 | 1,484 | 2,413 |
Net cash provided by financing activities | 198,453 | 26,484 | 27,291 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 134,682 | (732) | (215,788) |
Cash, cash equivalents and restricted cash at beginning of period | 92,901 | 93,633 | 309,421 |
Cash, cash equivalents and restricted cash at end of period | 227,583 | 92,901 | 93,633 |
Supplemental cash flow information: | |||
Cash paid for interest | 5,092 | 3,822 | 2,961 |
Cash paid for leases | 7,364 | 8,486 | 5,375 |
Supplemental disclosure of non-cash investing and financing information: | |||
Purchases of property, plant and equipment included in accounts payable or accrued expenses | 1,989 | 317 | 3,095 |
Offering costs and issuance costs included in accounts payable and accrued expenses | $ 35 | ||
Lease assets obtained in exchange for new operating lease liabilities | 496 | 49,799 | |
Proceeds from issuance of common stock upon exercise of stock options in other current assets | $ 32 | ||
Lease asset derecognized upon lease cancellation | $ 982 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Nature of the Business and Basis of Presentation | |
Nature of the Business and Basis of Presentation | RUBIUS THERAPEUTICS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. Nature of the Business and Basis of Presentation Rubius Therapeutics, Inc. (“Rubius” or the “Company”) is a biopharmaceutical company that is using its platform to genetically engineer red blood cells into medicines, called Red Cell Therapeutics, for the treatment of cancer and autoimmune diseases. Rubius was incorporated in April 2013 as VL26, Inc. under the laws of the State of Delaware. In January 2015, the Company changed its name to Rubius Therapeutics, Inc. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the ability to establish clinical- and commercial-scale manufacturing processes and the ability to secure additional capital to fund operations. In addition, the Company is subject to uncertainty regarding the performance and safety of its product candidates in humans. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. T he Company is monitoring the potential impact of the novel coronavirus (“COVID-19”), if any, on the carrying value of certain assets. To date, the Company has not experienced material business disruption, nor has it incurred impairment of any assets as a result of COVID-19. The extent to which these events may impact the Company’s business will depend on future developments, which are highly uncertain and cannot be predicted at this time. The duration and intensity of these impacts and resulting disruption to the Company’s operations is uncertain and the Company will continue to assess the financial impact. On July 20, 2018, the Company completed its initial public offering (“IPO”), pursuant to which it issued and sold 12,055,450 shares of common stock, inclusive of 1,572,450 shares sold by the Company pursuant to the full exercise of the underwriters’ option to purchase additional shares. The aggregate net proceeds received by the Company from the IPO were $254.3 million, after deducting underwriting discounts and commissions and other offering costs. Upon the closing of the IPO, all of the shares of the Company’s outstanding convertible preferred stock then outstanding automatically converted into 51,845,438 shares of common stock. On March 18, 2021, the Company completed an underwritten public offering (the “March 2021 Offering”), pursuant to which it issued and sold 6,896,552 shares of common stock. The aggregate net proceeds received by the Company from the March 2021 Offering were $187.2 million, after deducting underwriting discounts and commissions and other offering costs. The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since inception, including net losses of $196.5 million, $167.7 million and $163.5 million for the years ended December 31, 2021, 2020 and 2019, respectively. As of December 31, 2021, the Company had an accumulated deficit of $677.0 million. The Company expects to continue to generate operating losses in the foreseeable future. Before considering management’s plans described below, the Company expects that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2023. The Company has financed its operations to date primarily through private placements, proceeds from its IPO and the March 2021 Offering and borrowings under credit facilities. The Company has devoted substantially all of its financial resources and efforts to research and development, including preclinical studies and clinical trials, and developing manufacturing capabilities. The Company will need to raise additional funds through private or public equity financings, debt financings, collaborations, strategic alliances or marketing, distribution or licensing arrangements to fund operations. The Company may not be able to obtain financing, or enter into collaboration or other arrangements, on acceptable terms, or at all. Furthermore, the terms of any financing may adversely affect the holdings or the rights of the Company's stockholders. If the Company is unable to obtain funding, the Company will implement an operating plan that scales back its operations and focuses its available capital on a reduced number of activities and programs, which it believes will enable the continued advancement of certain of its research and development programs and the preservation of its technology platform. These actions could adversely affect the Company’s business prospects. Based on the Company’s current cash and cash equivalents of $225.8 million as of , and after considering management’s operating plans, the Company has the ability to fund its operating costs and working capital needs into the middle of 2023. The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. Certain prior period amounts have been reclassified to conform to the current year presentation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. Concentrations of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, and investments. The Company’s cash and cash equivalents as of December 31, 2021 consisted of cash, money market accounts and U.S. government money market funds. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company relies, and expects to continue to rely, on a small number of vendors to manufacture supplies and raw materials for its development programs. These programs could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials. Deferred Offering Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should the in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss. Deferred Financing Costs The Company capitalizes certain legal and other third-party fees that are directly associated with obtaining access to capital under credit facilities. Deferred financing costs incurred in connection with obtaining access to capital are recorded in other assets and are amortized over the term of the credit facility. Deferred financing costs related to a recognized debt liability are recorded as a reduction of the carrying amount of the debt liability and amortized to interest expense using the effective interest method over the repayment term. Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Restricted Cash As of both December 31, 2021 and 2020, the Company maintained letters of credit totaling $1.7 million for the benefit of the landlords of its leased properties. The Company was required to maintain separate cash balances of these amounts to secure the letters of credit. Related to these separate cash balances, the Company included $0.1 million in prepaid expenses and other current assets and $1.6 million in restricted cash (non-current) in its consolidated balance sheet as of December 31, 2021 and 2020. Cash, cash equivalents and restricted cash presented in the accompanying consolidated statement of cash flows was $227.6 million, $92.9 million and $93.6 million for the years ended December 31, 2021, 2020 and 2019, respectively, of which $1.7 million was restricted cash for each year, respectively. Property, Plant and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated useful life Computer equipment 3 years Laboratory equipment 5 years Furniture and fixtures 7 years Manufacturing equipment 10 years Manufacturing facility 30 years Leasehold improvements Shorter of life of lease or 10 years Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for its intended use, at which point the interest costs are amortized as depreciation expense over the life of the underlying asset. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for major renewals and improvements which extend the life or usefulness of the asset are capitalized. Items of an ordinary repair or maintenance nature are charged directly to operating expense as incurred. Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use and eventual disposition of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. The Company did not record any impairment losses during the years ended December 31, 2021, 2020 and 2019. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1—Quoted prices in active markets for identical assets or liabilities. ● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents and investments are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities. The carrying value of the Company’s long-term debt approximates its fair value due to its variable interest rate, which approximates a market interest rate. Investments The Company’s investments are classified as available-for-sale and are carried at fair value. Realized gains and losses and declines in value are based on the specific identification method and are included as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company classifies its investments with maturities beyond one year as short-term, based on their highly liquid nature and because such investments are available for current operations. In June 2016, issued 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses , which changes the impairment model for most financial assets, including the Company’s investments. The Company adopted the standard effective January 1, 2020 using a prospective transition method. The adoption did not have a material impact on the Company’s consolidated financial statements. The Company evaluates its investments with unrealized losses for impairment. When assessing investments for unrealized declines in value, the Company considers whether the decline in value is related to a credit loss or non-credit loss. For credit losses, the Company reduces the investment to fair value through an allowance for credit losses recorded to the balance sheet and corresponding charge to the statement of operations. The allowance for credit losses and corresponding impairment charge is adjusted each period for changes in fair value. For non-credit losses, the Company reduces the investment to fair value through a charge to the statement of comprehensive loss, reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. No such credit losses were recorded during the periods presented. Leases The Company adopted ASC 842 using the modified retrospective approach with an effective date of January 1, 2019 for leases that existed on that date. Prior period results continue to be presented under ASC 840 based on the accounting standards originally in effect for such periods. At the inception of an arrangement as lessee or lessor, the Company determines whether the arrangement is or contains a lease. Operating lease cost is recognized over the lease term on a straight-line basis. Variable lease cost and short-term leases (lease terms less than 12 months) are recognized as incurred. For both lessee and lessor arrangements, variable lease payments are the amounts owed by the Company to a lessor that are not fixed, such as reimbursement for common area maintenance and utilities costs, and are expensed when incurred. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that it will exercise that option. For lessee arrangements, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Operating leases are recognized on the balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. The Company has elected the following lease policies at the inception of a lease: (1) for lessee and lessor arrangements within all asset classes, combine lease and non-lease components as a single component, with the lease expense recognized over the expected term on a straight-line basis and (2) for lessee arrangements, apply short-term lease exemption for all leases that qualify, where a right-of-use asset or lease liability will not be recognized for leases with terms of one year or less. Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is developing product candidates based on biologically engineered red blood cells for the treatment of patients with severe diseases. All of the Company’s tangible assets are held in the United States. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, stock-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, manufacturing expenses and external costs of vendors engaged to conduct preclinical development activities and clinical trials, as well as the cost of licensing technology. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. Research and Manufacturing Contract Costs and Accruals The Company has entered into various research and development and manufacturing contracts with research institutions and other companies both inside and outside of the U.S. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations as of period end with those third parties to record accruals for estimated ongoing research and development costs. Any accrual estimates are based on a number of factors, including the Company’s knowledge of the progress towards completion of the research and development activities, invoicing to date under the contracts, communication from the research institution or other companies of any actual costs incurred during the period that have not yet been invoiced, and the costs included in the contracts. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Stock-Based Compensation The Company measures stock options with service-based vesting or performance-based vesting granted to employees, non-employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model. The Company measures restricted common stock awards using the difference between the purchase price per share of the award, if any, and the fair value of the Company’s common stock. Compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award. The Company measures restricted stock units with service-based vesting as the market value of the Company’s stock on the date of grant. The Company uses the straight-line method to record the expense of awards with only service-based vesting conditions. The Company uses the graded-vesting method to record the expense of awards with both service-based and performance-based vesting conditions, commencing once achievement of the performance condition becomes probable. The Company accounts for forfeitures as they occur and records compensation cost assuming all option holders will complete the requisite service period. If an award is forfeited, the Company reverses compensation expense previously recognized in the period the award is forfeited. For stock-based awards with market-based vesting conditions, the Company measures the fair value on the date of grant using a Monte Carlo simulation model. When service-based vesting conditions also exist, the Company recognizes stock-based compensation expense using the graded-vesting method over the longer of the derived service period from the market condition or the required service period. In accordance with accounting guidance for awards with market conditions, the stock-based compensation expense will be recognized over the appropriate period regardless of whether the award achieves the market condition and will only be adjusted to the extent the service condition is not met. When an award contains a market-based vesting condition and a performance-based vesting condition where both must be achieved to earn the award, the Company recognizes stock-based compensation expense over the longer of the derived service period from the market condition or the period estimated for the performance-based vesting condition to be achieved. The Company begins recording stock-based compensation expense for this type of award once the achievement of the performance-based vesting condition becomes probable regardless of whether the market condition has been achieved. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. Comprehensive Loss Comprehensive loss includes net loss, as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For the years ended December 31, 2021, 2020 and 2019, the Company’s only element of other comprehensive loss was unrealized gains (losses) on investments. Net Income (Loss) per Share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding common stock equivalents. Accordingly, in periods in which the Company reported a net loss, dilutive common shares were not assumed to have been issued as their effect was anti-dilutive, and as a result, diluted net loss per common share was the same as basic net loss per common share. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate, as well as the related net interest and penalties. Recently Adopted Accounting Pronouncements ASU No. 2016-13, Financial Instruments—Credit Losses In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities are required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities are no longer permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. ASU No. 2018-13, Fair Value Measurement In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement 1, 2020 on a prospective basis. The adoption did not have an impact on the Company’s consolidated financial statements. ASU No. 2020-04, Reference Rate Reform In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting ASU No. 2019-12, Simplifying the Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (ASC 740). |
Investments and Fair Value of F
Investments and Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Investments and Fair Value of Financial Assets and Liabilities | |
Investments and Fair Value of Financial Assets and Liabilities | 3. Investments and Fair Value of Financial Assets and Liabilities The Company had no investments as of December 31, 2021. As of December 31, 2020, investments by security type consisted of the following (in thousands): December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Credit Losses Fair Value U.S. treasury bills and notes (due within one year) $ 85,118 $ 6 $ (2) $ — $ 85,122 $ 85,118 $ 6 $ (2) $ — $ 85,122 The following tables present the Company’s fair value hierarchy for its assets and liabilities, which are measured at fair value on a recurring basis (in thousands): Fair value measurements at December 31, 2021 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S. money market funds $ 217,009 $ — $ — $ 217,009 $ 217,009 $ — $ — $ 217,009 Fair value measurements at December 31, 2020 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S money market funds $ 88,814 $ — $ — $ 88,814 Investments: U.S. treasury bills and notes — 85,122 — 85,122 $ 88,814 $ 85,122 $ — $ 173,936 U.S. government money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. U.S. treasury notes were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. There have been no changes to the valuation methods during the year ended December 31, 2021. The Company evaluates transfers between levels at the end of each reporting period. There were no transfers between Level 1, Level 2 or Level 3 during the year ended December 31, 2021 and 2020, respectively. |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment, Net. | |
Property, Plant and Equipment, Net | 4. Property, Plant and Equipment, Net Property, plant and equipment, net consisted of the following (in thousands): December 31, 2021 2020 Land $ 1,300 $ 1,300 Manufacturing facility 33,203 30,969 Manufacturing equipment 8,831 8,782 Laboratory equipment 17,501 16,639 Computer equipment 2,645 2,118 Furniture and fixtures 1,281 1,228 Leasehold improvements 444 444 Construction-in-progress 4,181 2,605 69,386 64,085 Less: Accumulated depreciation and amortization (17,856) (10,133) $ 51,530 $ 53,952 Manufacturing Facility The Company owns a 135,000 square foot manufacturing facility located in Smithfield, Rhode Island. The facility was purchased in July 2018 for $8.0 million. During the remainder of 2018 and throughout 2019, it was renovated and customized to manufacture clinical supply of the Company’s product candidates and was placed into service in January 2020 after achieving the regulatory qualifications required to bring it to its intended use. The carrying value of the land represents an allocation of the original purchase price based on the value of comparable assets. The carrying value of the manufacturing facility represents the remaining purchase price, plus the capitalized design, demolition, construction and interest costs related to renovations and improvements. The Company continues to incur capital asset expenditures related to the operation of the manufacturing facility, which are capitalized as construction-in-progress until they are ready for their intended use and placed into service. Depreciation and amortization expense was $7.7 million, $5.7 million and $3.0 million for the years ended December 31, 2021, 2020 and 2019, respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued employee compensation and benefits $ 7,451 $ 8,124 Accrued external research and development expenses 2,713 3,156 Accrued manufacturing facility expenses 2,349 339 Accrued general and administrative expenses 889 1,244 Other 670 554 $ 14,072 $ 13,417 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt | |
Debt | 6. Debt Long-term debt consisted of the following (in thousands): December 31, 2021 December 31, 2020 Principal amount of long‑term debt $ 75,000 $ 75,000 Less: Current portion of long‑term debt — — Long‑term debt, net of current portion 75,000 75,000 Accrued final interest payment 1,654 408 Debt discount (500) (464) Long‑term debt, net of discount and current portion $ 76,154 $ 74,944 Loan Agreement On December 21, 2018 (the “Closing Date”), the Company entered into a loan and security agreement (the “Loan Agreement”) with Solar Capital Ltd. as collateral agent for the lenders party thereto for an aggregate principal amount of $75.0 million. The aggregate principal amount will be funded in three tranches of term loans of $25.0 million each. On the Closing Date, the Company made an initial borrowing of $25.0 million, in June 2019, the Company made a second borrowing of $25.0 million and in June 2020, the Company made a third and final borrowing of $25.0 million. On June 22, 2021 (the “Amendment Closing Date”), the Company entered into an amendment (the “Amendment”) to its Loan Agreement. Pursuant to the Amendment, the Company and its lenders agreed to extend the interest-only period applicable to borrowings under the Loan Agreement from December 21, 2021 until July 1, 2024 and the final maturity date from December 21, 2023 until June 1, 2026. An additional tranche in the amount of $35.0 million is available at the request of the Company prior to the final maturity date, to be provided at the sole discretion of the lenders. The Amendment increases the LIBOR interest rate floor from 0.00% to 2.10%. Interest on the outstanding loan balance will accrue at a rate of 5.50%, plus the greater of 2.10% or the one-month U.S. LIBOR rate. Certain back-end fees are due to the lender at the time of final repayment based on the total funded term loans. The Company accrues the back-end fees that will be due at final repayment to outstanding debt by charges to interest expense over the term of the loans using the effective interest method. The term loans are subject to a prepayment fee of 1.00% if prepayment occurs within the first year subsequent to the Amendment Closing Date, 0.50% in the second year and 0.25% in the third year through final maturity date. As the terms of the Amendment were not substantially different than the terms of the Loan Agreement, the Amendment was accounted for as a debt modification. In conjunction with the Amendment, the Company incurred issuance costs of $0.2 million payable to the lenders, which were recorded as an additional debt discount and will be amortized to interest expense over the remaining term, together with unamortized original issuance costs as of the Amendment Closing Date, using the effective interest method. The Loan Agreement contains financial covenants that require the Company to maintain either a certain minimum cash balance or a minimum market capitalization threshold. The Company was in compliance with all such financial covenants as of December 31, 2021. As of December 31, 2021, the estimated future principal payments due were as follows (in thousands): Year ending December 31, 2022 $ — 2023 — 2024 18,750 2025 37,500 2026 and thereafter 18,750 $ 75,000 |
Equity
Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity | |
Equity | 7. Equity Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are not entitled to receive dividends, unless declared by the board of directors. On July 20, 2018, the Company filed a restated certificate of incorporation in the State of Delaware, which, among other things, restated the number of shares of all classes of stock that the Company has authority to issue to 160,000,000 shares, consisting of (i) 150,000,000 shares of common stock, $0.001 par value per share, and (ii) 10,000,000 shares of preferred stock, $0.001 par value per share. The preferred stock will have such rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Company’s board of directors upon issuance. The shares of preferred stock are currently undesignated. On August 1, 2019, the Company entered into a Distribution Agreement (the “Distribution Agreement”) with J.P. Morgan Securities LLC, Jefferies LLC and SVB Leerink LLC (the “Sales Agents”), pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $100.0 million through the Sales Agents. The Company’s registration statement on Form S-3 filed on August 1, 2019 was declared effective on August 21, 2019. The Sales Agents may sell common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Global Select Market or any other existing trade market for the common stock, in negotiated transactions at market prices prevailing at the time of sale or at prices related to prevailing market prices, or any other method permitted by law. The Sales Agents will be entitled to receive 3.0% of the gross sales price per share of common stock sold pursuant to the Distribution Agreement. As of December 31, 2021, no shares of common stock have been issued and sold pursuant to the Distribution Agreement. On March 18, 2021, the Company completed the March 2021 Offering, pursuant to which it issued and sold 6,896,552 shares of common stock. The aggregate net proceeds received by the Company from the March 2021 Offering were $187.2 million, after deducting underwriting discounts and commissions and other offering costs. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. Stock-Based Compensation 2018 Equity Incentive Plan On July 6, 2018, the Company’s board of directors adopted, and its stockholders approved, the 2018 Plan, which became effective on July 16, 2018. The 2018 Plan provides for the grant of incentive stock options, non-qualified options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. The number of shares initially reserved for issuance under the 2018 Plan is 5,708,931, which shall be cumulatively increased on January 1, 2019 and each January 1 thereafter by 4% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s board of directors or compensation committee of the board of directors. The shares of common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expire or are otherwise terminated (other than by exercise) under the 2018 Plan. As of December 31, 2021, 3,290,353 shares remained available for issuance under the 2018 Plan. The number of authorized shares reserved for issuance under the 2018 Plan was increased by 3,152,231 shares effective as of January 1, 2022. 2018 Employee Stock Purchase Plan On July 6, 2018, the Company’s board of directors adopted and its stockholders approved the 2018 Employee Stock Purchase Plan (the “ESPP”), which became effective on July 16, 2018. A total of 951,488 shares of common stock were reserved for issuance under this plan. In addition, the number of shares of common stock that may be issued under the ESPP will automatically increase on January 1, 2019, and each January 1 thereafter through January 1, 2028, by the least of (i) 951,488 shares of common stock, (ii) 1% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or (iii) such lesser number of shares as determined by the administrator of the Company’s ESPP. As of December 31, 2021, 1,717,392 shares remained available for issuance under the 2018 ESPP. The number of authorized shares reserved for issuance under the ESPP was no t increased on January 1, 2022. Stock Option Valuation Service-Based and Performance-Based Stock Options The fair value of stock option grants with service-based and performance-based vesting conditions is estimated using the Black-Scholes option-pricing model. The Company estimates expected volatility based on the historical volatility of publicly traded peer companies. The Company expects to continue to do so until such time as it has adequate historical data regarding the volatility of its traded stock price following our July 2018 IPO. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the fair value of stock-based awards granted to employees, directors, and non-employees: Year ended December 31, 2021 2020 2019 Risk-free interest rate 0.81 % 1.10 % 2.07 % Expected volatility 77.4 % 69.4 % 76.9 % Expected dividend yield — — — Expected term (in years) 6.08 6.05 6.06 The following table summarizes the Company’s service-based and performance-based option activity since December 31, 2021: Weighted Weighted average average Aggregate Number of exercise contractual intrinsic shares price term value (in years) (in thousands) Outstanding as of December 31, 2020 15,960,324 $ 10.17 7.38 $ 15,018 Granted 4,138,080 15.80 Exercised (1,933,523) 5.53 Forfeited (1,026,109) 10.37 Outstanding as of December 31, 2021 17,138,772 $ 12.04 7.22 $ 23,511 Vested and expected to vest as of December 31, 2021 17,138,772 $ 12.04 7.22 $ 23,511 Options exercisable as of December 31, 2021 10,554,855 $ 11.52 6.42 $ 18,126 The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2021, 2020 and 2019 was $34.6 million, $5.7 million and $17.7 million, respectively. The weighted average grant-date fair value of stock options granted during the years ended December 31, 2021, 2020 and 2019 was $10.55 per share, $4.51 per share and $8.58 per share, respectively. Market-Based Stock Options The fair value of stock option grants with market-based vesting conditions is estimated using a Monte Carlo simulation model. In October 2018, the Company granted to an executive officer an option to purchase 164,400 shares of common stock (“Option A”) at an exercise price of $16.43 per share, vesting upon the achievement of a specified thirty-day average closing price of its common stock and the satisfaction of service-based vesting conditions, and an option to purchase 193,400 shares of common stock (“Option B”) at an exercise price of $16.43 per share, vesting upon the achievement of a specified thirty-day average closing price of its common stock and the achievement of certain other performance-based vesting conditions. The Company used a Monte Carlo simulation model to estimate the grant-date fair value of the awards. Assumptions and estimates utilized in the model include the risk-free interest rate, dividend yield, expected stock volatility based on a combination of the Company’s historical stock volatility since its July 2018 IPO and the historical volatility of a publicly traded set of peer companies and the estimated period to achievement of the market condition. Stock-based compensation expense for Option A is being recognized using the graded-vesting method over the longer of the derived service period from the market condition or the explicit service period required to be completed for each vesting tranche. Stock-based compensation expense for Option B is being recognized using the graded-vesting method over the longer of the derived service period from the market condition or the estimated achievement of performance-based conditions. For Option B, stock-based compensation expense is recognized when the achievement of each performance-based vesting condition becomes probable regardless of whether the market condition has been achieved. The aggregate grant date fair value of these options was $4.3 million. During the years ended December 31, 2021, 2020 and 2019 the Company recorded stock-based compensation expense on Option A of $0.2 million, $0.6 million and $0.9 million, respectively. During the years ended December 31, 2021 and 2020, the Company recorded stock-based compensation expense on Option B of $1.1 million and $1.1 million, respectively, as a performance-based vesting condition was determined to be probable during each year. No stock-based compensation expense on Option B was recorded during the year ended December 31, 2019. The Company did not grant market-based stock options during the years ended December 31, 2021, 2020 and 2019. During the years ended December 31, 2021, 2020 and 2019, none of the outstanding stock options with market-based vesting conditions were exercised, forfeited or vested and they had no intrinsic value at December 31, 2021. Restricted Stock Units The Company has also granted restricted stock units to its employees. During the years ended December 31, 2021 and 2019, the Company granted restricted stock units to employees that were subject to time-based vesting conditions that lapse over four years and three years, respectively, from date of grant. No restricted stock units were granted during the year ended December 31, 2020. Restricted stock units with time-based vesting conditions are valued on the grant date using the grant date market price of the underlying shares. Weighted average grant ‑ date Shares fair value Unvested restricted common stock as of December 31, 2020 252,000 $ 10.660 Issued 787,107 15.505 Vested (153,600) 10.660 Forfeited (91,263) 11.660 Unvested restricted common stock as of December 31, 2021 794,244 $ 15.346 Stock-Based Compensation The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands): Year ended December 31, 2021 2020 2019 Research and development expenses $ 12,338 $ 8,023 $ 9,011 General and administrative expenses 23,272 25,642 32,260 $ 35,610 $ 33,665 $ 41,271 As of December 31, 2021, total unrecognized compensation cost related to unvested stock-based awards was $57.3 million, which is expected to be recognized over a weighted average period of 2.5 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | 9. Income Taxes During the years ended December 31, 2021, 2020 and 2019, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each year, due to its uncertainty of realizing a benefit from those items. All of the Company’s operating losses since inception have been generated in the United States. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year ended December 31, 2021 2020 Federal statutory income tax rate (21.0) % (21.0) % State taxes, net of federal benefit (6.2) (6.2) Federal and state research and development tax credits (6.4) (5.9) Stock‑based compensation expense (1.6) 0.4 Section 162(m) compensation deduction limitation 1.6 — Other (0.4) 0.5 Increase in deferred tax asset valuation allowance 34.0 32.2 Effective income tax rate — % — % Net deferred tax assets consisted of the following (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 145,990 $ 97,791 Research and development tax credit carryforwards 36,161 23,524 Accrued expenses 2,137 2,241 Capitalized intellectual property costs 1,746 1,123 Capitalized research and development expense 86 97 Operating lease liabilities 10,194 11,394 Stock‑based compensation expense 21,483 15,847 Total deferred tax assets 217,797 152,017 Deferred tax liabilities: Operating lease assets (9,590) (11,050) Depreciation and other (1,500) (1,090) Total deferred tax liabilities (11,090) (12,140) Valuation allowance (206,707) (139,877) Net deferred tax assets $ — $ — As of December 31, 2021, the Company had U.S. federal and state net operating loss (“NOL”) carryforwards of $534.2 million and $534.8 million, respectively, which may be available to offset future taxable income. The federal NOLs include $37.2 million which expire at various dates through 2037 and $497.0 million which carryforward indefinitely. The state NOLs expire at various dates through 2041. As of December 31, 2021, the Company also had U.S. federal and state research and development tax credit carryforwards of $22.7 million and $15.6 million, respectively, which may be available to offset future tax liabilities and begin to expire in 2034 and 2026, respectively. During the year ended December 31, 2021, deferred tax assets, before valuation allowance, increased by approximately $65.8 million mainly due to the operating loss incurred by the Company during that period. Utilization of the U.S. federal and state net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income or tax liabilities. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. Further, until a study is completed by the Company and any limitation is known, no amounts are being presented as an uncertain tax position. The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the net deferred tax assets as of December 31, 2021 and 2020. Management reevaluates the positive and negative evidence at each reporting period. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2021, 2020 and 2019 related primarily to the increase in net operating loss carryforwards and research and development tax credit carryforwards and were as follows (in thousands): Year ended December 31, 2021 2020 2019 Valuation allowance as of beginning of year $ 139,877 $ 85,884 $ 33,666 Decreases recorded as benefit to income tax provision — — — Increases recorded to income tax provision 66,830 53,993 52,218 Valuation allowance as of end of year $ 206,707 $ 139,877 $ 85,884 As of December 31, 2021 and 2020, the Company had not recorded any amounts for unrecognized tax benefits. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2021 and 2020, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts had been recognized in the Company’s consolidated statements of operations and comprehensive loss. The Company files income tax returns in the U.S., Massachusetts and Rhode Island, as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending tax examinations. The Company is open to future tax examination under statute from 2016 to the present; however, carryforward attributes that were generated prior to January 1, 2016 may still be adjusted upon examination by federal, state or local tax authorities if they either have been or will be used in a future period. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 10. Commitments and Contingencies License Agreement with the Whitehead Institute for Biomedical Research The Company has a license agreement with the Whitehead Institute for Biomedical Research (“WIBR”), as amended, under which the Company has been granted an exclusive, sublicensable, nontransferable license under certain patent families related to the development of the Company’s red blood cell therapies (the “WIBR License”). The Company is obligated to pay WIBR annual license maintenance fees of less than $0.1 million, as well as patent-related costs, including legal fees, and low single-digit royalties based on annual net sales of licensed products and licensed services by the Company and its sublicensees. Based on the progress the Company makes in the advancement of products covered by the licensed patent rights, the Company is required to make aggregate milestone payments of up to $1.6 million upon the achievement of specified preclinical, clinical and regulatory milestones. In addition, the Company is required to pay to WIBR a percentage of the non-royalty payments that it receives from sublicensees of the patent rights licensed by WIBR. This percentage varies from low single-digit to low double-digit percentages and will be based upon the clinical stage of the product that is the subject of the sublicense. Royalties shall be paid by the Company on a licensed product-by-licensed product and country-by-country basis, beginning on the first commercial sale of such licensed product in such country until expiration of the last valid patent claim covering such licensed product in such country. The Company has the right to terminate the WIBR License in its entirety, on a patent-by-patent or country-by-country basis, at will upon three months’ notice to WIBR. WIBR may terminate the agreement upon breach of contract or in the event of the Company’s bankruptcy, liquidation, insolvency or cessation of business related to the license. 401(k) Plan 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 and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company makes matching contributions at a rate of 50% of each employee’s contribution up to a maximum employee contribution of 6% of eligible plan compensation. For the years ended December 31, 2021, 2020 and 2019, the Company made matching contributions of $0.9 million, $0.8 million and $0.6 million, respectively. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, contract research organizations, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. The Company has not incurred any material costs as a result of such indemnifications and is not currently aware of any indemnification claims. Legal Proceedings The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Leases | 11. Leases Operating Leases During the year ended December 31, 2021, the Company leased office and laboratory facilities in Cambridge, Massachusetts under two noncancelable operating leases. The first lease expired in September 2021. The second lease is subject to two expiration dates based on two distinct leased spaces, expiring in January 2027 and August 2028. The lease agreements include lease incentives and payment escalations. In January 2018, the Company entered into a lease for office and laboratory space in Cambridge, Massachusetts (the “Initial Space”). The lease term commenced on January 28, 2019 and expires eight years from the commencement date. The Company is entitled to one five-year option to extend, which is not included in the lease term. The initial annual base rent is approximately $3.8 million, and such amount will increase during the initial term by 3% annually on the anniversary of the commencement date. The Company is obligated to pay its portion of real estate taxes and costs related to the premises, including costs of operations, maintenance, repair, replacement and management of the new leased premises. In connection with the lease, the Company maintains a letter of credit for the benefit of the landlord in the amount of $0.9 million, which is collateralized by a cash deposit of the same amount. The lease agreement allows for a landlord-provided tenant improvement allowance of $9.4 million to be applied to the costs of the construction of the leasehold improvements, of which $0.5 million is repayable to the landlord over the term of the lease. In November 2018, the Company entered into a lease amendment for office and laboratory space in the same building (the “Expansion Space”). The lease term for the Expansion Space commenced on August 8, 2019 and expires approximately nine years from the commencement date. The initial annual base rent for the Expansion Space is approximately $2.5 million and such amount will increase by 3% annually on the anniversary of the commencement date. The Company is obligated to pay its portion of real estate taxes and costs related to the Expansion Space, including costs of operations, maintenance, repair, replacement and property management. In connection with the lease amendment, the Company increased the letter of credit held for the benefit of the landlord by $0.6 million, which is collateralized by a cash deposit of the same amount. The lease amendment increased the landlord-provided tenant improvement allowance by $9.2 million, of which $2.0 million is repayable to the landlord over the term of the lease. The Company evaluated its vendor contracts to identify embedded leases, if any, and noted that an agreement with a contract manufacturing supplier constituted a lease under ASC 842 as the Company has the right to substantially all the economic benefits from the use of the asset and can direct the use of the asset. The Company entered into the agreement during the first quarter of 2019. The lease commenced during March 2019 and was scheduled to expire 22 months from commencement date with no stated option to extend the term. The lease was cancelled prior to expiration during the first quarter of 2020, resulting in derecognition of the lease assets and operating lease liabilities. As the Company’s leases do not provide an implicit rate, the Company utilized its incremental borrowing rate based on information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. The Company has elected to account for each lease component and its associated non-lease components as a single lease component and, therefore, has allocated all the contract consideration across lease components only. This may result in the initial and subsequent measurement of the balances of the right-of-use asset and lease liability for leases being greater than if the policy election was not applied. Assets under operating lease at December 31, 2021 were $35.1 million. The leases do not include any restrictions or covenants that had to be accounted for under the lease guidance. As of December 31, 2021, minimum lease payments under the Company’s operating leases are as follows (in thousands): Year ending December 31, 2022 $ 9,015 2023 7,447 2024 7,601 2025 7,818 2026 8,041 Thereafter 6,199 46,121 Less: imputed interest (8,815) $ 37,306 The Company has not entered any material financing leases as of December 31, 2021. Lease Portfolio The components of lease cost and supplemental balance sheet information for the Company’s lease portfolio were as follows (in thousands, except term and discount rate amounts): Year ended December 31, 2021 2020 2019 Lease cost: Operating lease cost $ 8,173 $ 9,240 $ 7,208 Short-term lease cost 41 24 127 Variable lease cost 3,723 1,916 1,976 Sublease income (719) (1,017) (908) Total lease cost $ 11,218 $ 10,163 $ 8,403 Operating leases: Operating lease, right-of-use-asset $ 35,095 $ 40,447 $ 46,559 Operating lease liabilities $ 9,015 $ 8,945 $ 10,540 Operating lease liabilities, net of current portion $ 28,291 $ 32,762 $ 36,867 Other information: Weighted average remaining lease term - operating leases 5.8 years 6.70 years 7.47 years Weighted-average discount rate - operating leases 7.60% 7.60% 7.58% |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2021 | |
Net Loss per Share | |
Net Loss per Share | 12. Net Loss per Share Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts): Year ended December 31, 2021 2020 2019 Numerator: Net loss $ (196,547) $ (167,731) (163,458) Denominator: Weighted average common shares outstanding, basic and diluted 87,950,440 80,624,608 78,688,878 Net loss per share, basic and diluted $ (2.23) $ (2.08) $ (2.08) The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares from the periods in the table above, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Year ended December 31, 2021 2020 2019 Unvested restricted common stock 794,244 252,000 376,514 Stock options to purchase common stock 17,496,572 16,318,124 15,103,907 18,290,816 16,570,124 15,480,421 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. |
Concentrations of Credit Risk and of Significant Suppliers | Concentrations of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, and investments. The Company’s cash and cash equivalents as of December 31, 2021 consisted of cash, money market accounts and U.S. government money market funds. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company relies, and expects to continue to rely, on a small number of vendors to manufacture supplies and raw materials for its development programs. These programs could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should the in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss. |
Deferred Financing Costs | Deferred Financing Costs The Company capitalizes certain legal and other third-party fees that are directly associated with obtaining access to capital under credit facilities. Deferred financing costs incurred in connection with obtaining access to capital are recorded in other assets and are amortized over the term of the credit facility. Deferred financing costs related to a recognized debt liability are recorded as a reduction of the carrying amount of the debt liability and amortized to interest expense using the effective interest method over the repayment term. |
Cash Equivalents | Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. |
Restricted Cash | Restricted Cash As of both December 31, 2021 and 2020, the Company maintained letters of credit totaling $1.7 million for the benefit of the landlords of its leased properties. The Company was required to maintain separate cash balances of these amounts to secure the letters of credit. Related to these separate cash balances, the Company included $0.1 million in prepaid expenses and other current assets and $1.6 million in restricted cash (non-current) in its consolidated balance sheet as of December 31, 2021 and 2020. Cash, cash equivalents and restricted cash presented in the accompanying consolidated statement of cash flows was $227.6 million, $92.9 million and $93.6 million for the years ended December 31, 2021, 2020 and 2019, respectively, of which $1.7 million was restricted cash for each year, respectively. |
Property, Plant and Equipment | Property, Plant and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated useful life Computer equipment 3 years Laboratory equipment 5 years Furniture and fixtures 7 years Manufacturing equipment 10 years Manufacturing facility 30 years Leasehold improvements Shorter of life of lease or 10 years Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for its intended use, at which point the interest costs are amortized as depreciation expense over the life of the underlying asset. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for major renewals and improvements which extend the life or usefulness of the asset are capitalized. Items of an ordinary repair or maintenance nature are charged directly to operating expense as incurred. |
Impairment of Long Lived Assets | Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use and eventual disposition of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. The Company did not record any impairment losses during the years ended December 31, 2021, 2020 and 2019. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1—Quoted prices in active markets for identical assets or liabilities. ● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents and investments are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities. The carrying value of the Company’s long-term debt approximates its fair value due to its variable interest rate, which approximates a market interest rate. |
Investments | Investments The Company’s investments are classified as available-for-sale and are carried at fair value. Realized gains and losses and declines in value are based on the specific identification method and are included as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company classifies its investments with maturities beyond one year as short-term, based on their highly liquid nature and because such investments are available for current operations. In June 2016, issued 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses , which changes the impairment model for most financial assets, including the Company’s investments. The Company adopted the standard effective January 1, 2020 using a prospective transition method. The adoption did not have a material impact on the Company’s consolidated financial statements. The Company evaluates its investments with unrealized losses for impairment. When assessing investments for unrealized declines in value, the Company considers whether the decline in value is related to a credit loss or non-credit loss. For credit losses, the Company reduces the investment to fair value through an allowance for credit losses recorded to the balance sheet and corresponding charge to the statement of operations. The allowance for credit losses and corresponding impairment charge is adjusted each period for changes in fair value. For non-credit losses, the Company reduces the investment to fair value through a charge to the statement of comprehensive loss, reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. No such credit losses were recorded during the periods presented. |
Leases | Leases The Company adopted ASC 842 using the modified retrospective approach with an effective date of January 1, 2019 for leases that existed on that date. Prior period results continue to be presented under ASC 840 based on the accounting standards originally in effect for such periods. At the inception of an arrangement as lessee or lessor, the Company determines whether the arrangement is or contains a lease. Operating lease cost is recognized over the lease term on a straight-line basis. Variable lease cost and short-term leases (lease terms less than 12 months) are recognized as incurred. For both lessee and lessor arrangements, variable lease payments are the amounts owed by the Company to a lessor that are not fixed, such as reimbursement for common area maintenance and utilities costs, and are expensed when incurred. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that it will exercise that option. For lessee arrangements, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Operating leases are recognized on the balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. The Company has elected the following lease policies at the inception of a lease: (1) for lessee and lessor arrangements within all asset classes, combine lease and non-lease components as a single component, with the lease expense recognized over the expected term on a straight-line basis and (2) for lessee arrangements, apply short-term lease exemption for all leases that qualify, where a right-of-use asset or lease liability will not be recognized for leases with terms of one year or less. |
Segment Information | Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is developing product candidates based on biologically engineered red blood cells for the treatment of patients with severe diseases. All of the Company’s tangible assets are held in the United States. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, stock-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, manufacturing expenses and external costs of vendors engaged to conduct preclinical development activities and clinical trials, as well as the cost of licensing technology. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. |
Research and Manufacturing Contract Costs and Accruals | Research and Manufacturing Contract Costs and Accruals The Company has entered into various research and development and manufacturing contracts with research institutions and other companies both inside and outside of the U.S. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations as of period end with those third parties to record accruals for estimated ongoing research and development costs. Any accrual estimates are based on a number of factors, including the Company’s knowledge of the progress towards completion of the research and development activities, invoicing to date under the contracts, communication from the research institution or other companies of any actual costs incurred during the period that have not yet been invoiced, and the costs included in the contracts. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs. |
Patent Costs | Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. |
Stock Based Compensation | Stock-Based Compensation The Company measures stock options with service-based vesting or performance-based vesting granted to employees, non-employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model. The Company measures restricted common stock awards using the difference between the purchase price per share of the award, if any, and the fair value of the Company’s common stock. Compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award. The Company measures restricted stock units with service-based vesting as the market value of the Company’s stock on the date of grant. The Company uses the straight-line method to record the expense of awards with only service-based vesting conditions. The Company uses the graded-vesting method to record the expense of awards with both service-based and performance-based vesting conditions, commencing once achievement of the performance condition becomes probable. The Company accounts for forfeitures as they occur and records compensation cost assuming all option holders will complete the requisite service period. If an award is forfeited, the Company reverses compensation expense previously recognized in the period the award is forfeited. For stock-based awards with market-based vesting conditions, the Company measures the fair value on the date of grant using a Monte Carlo simulation model. When service-based vesting conditions also exist, the Company recognizes stock-based compensation expense using the graded-vesting method over the longer of the derived service period from the market condition or the required service period. In accordance with accounting guidance for awards with market conditions, the stock-based compensation expense will be recognized over the appropriate period regardless of whether the award achieves the market condition and will only be adjusted to the extent the service condition is not met. When an award contains a market-based vesting condition and a performance-based vesting condition where both must be achieved to earn the award, the Company recognizes stock-based compensation expense over the longer of the derived service period from the market condition or the period estimated for the performance-based vesting condition to be achieved. The Company begins recording stock-based compensation expense for this type of award once the achievement of the performance-based vesting condition becomes probable regardless of whether the market condition has been achieved. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding common stock equivalents. Accordingly, in periods in which the Company reported a net loss, dilutive common shares were not assumed to have been issued as their effect was anti-dilutive, and as a result, diluted net loss per common share was the same as basic net loss per common share. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate, as well as the related net interest and penalties. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements ASU No. 2016-13, Financial Instruments—Credit Losses In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities are required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities are no longer permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. ASU No. 2018-13, Fair Value Measurement In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement 1, 2020 on a prospective basis. The adoption did not have an impact on the Company’s consolidated financial statements. ASU No. 2020-04, Reference Rate Reform In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting ASU No. 2019-12, Simplifying the Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (ASC 740). |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of property plant and equipment | Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated useful life Computer equipment 3 years Laboratory equipment 5 years Furniture and fixtures 7 years Manufacturing equipment 10 years Manufacturing facility 30 years Leasehold improvements Shorter of life of lease or 10 years |
Investments and Fair Value of_2
Investments and Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments and Fair Value of Financial Assets and Liabilities | |
Schedule of investments by security type | The Company had no investments as of December 31, 2021. As of December 31, 2020, investments by security type consisted of the following (in thousands): December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Credit Losses Fair Value U.S. treasury bills and notes (due within one year) $ 85,118 $ 6 $ (2) $ — $ 85,122 $ 85,118 $ 6 $ (2) $ — $ 85,122 |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | The following tables present the Company’s fair value hierarchy for its assets and liabilities, which are measured at fair value on a recurring basis (in thousands): Fair value measurements at December 31, 2021 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S. money market funds $ 217,009 $ — $ — $ 217,009 $ 217,009 $ — $ — $ 217,009 Fair value measurements at December 31, 2020 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S money market funds $ 88,814 $ — $ — $ 88,814 Investments: U.S. treasury bills and notes — 85,122 — 85,122 $ 88,814 $ 85,122 $ — $ 173,936 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment, Net. | |
Schedule of property, plant and equipment, Net | Property, plant and equipment, net consisted of the following (in thousands): December 31, 2021 2020 Land $ 1,300 $ 1,300 Manufacturing facility 33,203 30,969 Manufacturing equipment 8,831 8,782 Laboratory equipment 17,501 16,639 Computer equipment 2,645 2,118 Furniture and fixtures 1,281 1,228 Leasehold improvements 444 444 Construction-in-progress 4,181 2,605 69,386 64,085 Less: Accumulated depreciation and amortization (17,856) (10,133) $ 51,530 $ 53,952 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued employee compensation and benefits $ 7,451 $ 8,124 Accrued external research and development expenses 2,713 3,156 Accrued manufacturing facility expenses 2,349 339 Accrued general and administrative expenses 889 1,244 Other 670 554 $ 14,072 $ 13,417 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt | |
Schedule of long term debt | Long-term debt consisted of the following (in thousands): December 31, 2021 December 31, 2020 Principal amount of long‑term debt $ 75,000 $ 75,000 Less: Current portion of long‑term debt — — Long‑term debt, net of current portion 75,000 75,000 Accrued final interest payment 1,654 408 Debt discount (500) (464) Long‑term debt, net of discount and current portion $ 76,154 $ 74,944 |
Schedule of estimated future principal payments due | As of December 31, 2021, the estimated future principal payments due were as follows (in thousands): Year ending December 31, 2022 $ — 2023 — 2024 18,750 2025 37,500 2026 and thereafter 18,750 $ 75,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair value of stock-based awards granted to employees, directors, and, in 2018, non-employees, subsequent to the adoption of ASU 2018-07 | |
Schedule of stock option activity | Weighted Weighted average average Aggregate Number of exercise contractual intrinsic shares price term value (in years) (in thousands) Outstanding as of December 31, 2020 15,960,324 $ 10.17 7.38 $ 15,018 Granted 4,138,080 15.80 Exercised (1,933,523) 5.53 Forfeited (1,026,109) 10.37 Outstanding as of December 31, 2021 17,138,772 $ 12.04 7.22 $ 23,511 Vested and expected to vest as of December 31, 2021 17,138,772 $ 12.04 7.22 $ 23,511 Options exercisable as of December 31, 2021 10,554,855 $ 11.52 6.42 $ 18,126 |
Schedule of restricted stock unit activity | Weighted average grant ‑ date Shares fair value Unvested restricted common stock as of December 31, 2020 252,000 $ 10.660 Issued 787,107 15.505 Vested (153,600) 10.660 Forfeited (91,263) 11.660 Unvested restricted common stock as of December 31, 2021 794,244 $ 15.346 |
Schedule of allocation of share based compensation | The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands): Year ended December 31, 2021 2020 2019 Research and development expenses $ 12,338 $ 8,023 $ 9,011 General and administrative expenses 23,272 25,642 32,260 $ 35,610 $ 33,665 $ 41,271 |
Employees, directors and non-employees | |
Fair value of stock-based awards granted to employees, directors, and, in 2018, non-employees, subsequent to the adoption of ASU 2018-07 | |
Schedule of assumptions used to determine the fair value of stock awards granted | Year ended December 31, 2021 2020 2019 Risk-free interest rate 0.81 % 1.10 % 2.07 % Expected volatility 77.4 % 69.4 % 76.9 % Expected dividend yield — — — Expected term (in years) 6.08 6.05 6.06 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of reconciliation of the U.S. federal statutory income tax rate to the Company's effective income tax | Year ended December 31, 2021 2020 Federal statutory income tax rate (21.0) % (21.0) % State taxes, net of federal benefit (6.2) (6.2) Federal and state research and development tax credits (6.4) (5.9) Stock‑based compensation expense (1.6) 0.4 Section 162(m) compensation deduction limitation 1.6 — Other (0.4) 0.5 Increase in deferred tax asset valuation allowance 34.0 32.2 Effective income tax rate — % — % |
Net deferred tax assets | Net deferred tax assets consisted of the following (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 145,990 $ 97,791 Research and development tax credit carryforwards 36,161 23,524 Accrued expenses 2,137 2,241 Capitalized intellectual property costs 1,746 1,123 Capitalized research and development expense 86 97 Operating lease liabilities 10,194 11,394 Stock‑based compensation expense 21,483 15,847 Total deferred tax assets 217,797 152,017 Deferred tax liabilities: Operating lease assets (9,590) (11,050) Depreciation and other (1,500) (1,090) Total deferred tax liabilities (11,090) (12,140) Valuation allowance (206,707) (139,877) Net deferred tax assets $ — $ — |
Summary of changes in the valuation allowance for deferred tax assets | Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2021, 2020 and 2019 related primarily to the increase in net operating loss carryforwards and research and development tax credit carryforwards and were as follows (in thousands): Year ended December 31, 2021 2020 2019 Valuation allowance as of beginning of year $ 139,877 $ 85,884 $ 33,666 Decreases recorded as benefit to income tax provision — — — Increases recorded to income tax provision 66,830 53,993 52,218 Valuation allowance as of end of year $ 206,707 $ 139,877 $ 85,884 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Schedule of minimum lease payments under the Company's operating leases | As of December 31, 2021, minimum lease payments under the Company’s operating leases are as follows (in thousands): Year ending December 31, 2022 $ 9,015 2023 7,447 2024 7,601 2025 7,818 2026 8,041 Thereafter 6,199 46,121 Less: imputed interest (8,815) $ 37,306 |
Schedule of lease cost and lease liabilities for the Company's lease portfolio | The components of lease cost and supplemental balance sheet information for the Company’s lease portfolio were as follows (in thousands, except term and discount rate amounts): Year ended December 31, 2021 2020 2019 Lease cost: Operating lease cost $ 8,173 $ 9,240 $ 7,208 Short-term lease cost 41 24 127 Variable lease cost 3,723 1,916 1,976 Sublease income (719) (1,017) (908) Total lease cost $ 11,218 $ 10,163 $ 8,403 Operating leases: Operating lease, right-of-use-asset $ 35,095 $ 40,447 $ 46,559 Operating lease liabilities $ 9,015 $ 8,945 $ 10,540 Operating lease liabilities, net of current portion $ 28,291 $ 32,762 $ 36,867 Other information: Weighted average remaining lease term - operating leases 5.8 years 6.70 years 7.47 years Weighted-average discount rate - operating leases 7.60% 7.60% 7.58% |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Net Loss per Share | |
Schedule of calculation of basic and diluted net loss per share attributable to common stockholders | Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts): Year ended December 31, 2021 2020 2019 Numerator: Net loss $ (196,547) $ (167,731) (163,458) Denominator: Weighted average common shares outstanding, basic and diluted 87,950,440 80,624,608 78,688,878 Net loss per share, basic and diluted $ (2.23) $ (2.08) $ (2.08) |
Schedule of dilutive securities excluded from computations of diluted weighted average shares outstanding | Year ended December 31, 2021 2020 2019 Unvested restricted common stock 794,244 252,000 376,514 Stock options to purchase common stock 17,496,572 16,318,124 15,103,907 18,290,816 16,570,124 15,480,421 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Details) - USD ($) $ in Thousands | Mar. 18, 2021 | Jul. 20, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Sale of Equity | |||||
Net proceeds after deducting underwriting discounts and commissions | $ 188,000 | ||||
Net Loss | (196,547) | $ (167,731) | $ (163,458) | ||
Accumulated deficit | (677,018) | $ (480,471) | |||
Current cash and investments | $ 225,800 | ||||
Common stock | |||||
Sale of Equity | |||||
Shares issued (in shares) | 6,896,552 | 1,449,309 | |||
Conversion of redeemable convertible preferred stock to common stock (in shares) | 51,845,438 | ||||
IPO | |||||
Sale of Equity | |||||
Shares issued (in shares) | 12,055,450 | ||||
Offering | |||||
Sale of Equity | |||||
Shares issued (in shares) | 6,896,552 | ||||
Net proceeds after deducting underwriting discounts and commissions | $ 187,200 | ||||
Overallotment | |||||
Sale of Equity | |||||
Shares issued (in shares) | 1,572,450 | ||||
Net proceeds after deducting underwriting discounts and commissions | $ 254,300 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Summary of Significant Accounting Policies | ||||
Restricted cash for the benefit of its leased properties | $ 1,700 | $ 1,700 | ||
Restricted cash (current) | $ 100 | |||
Current restricted cash included in prepaid expense and other current assets | us-gaap:PrepaidExpenseAndOtherAssetsCurrent | us-gaap:PrepaidExpenseAndOtherAssetsCurrent | ||
Restricted cash (non-current) | $ 1,573 | $ 1,573 | ||
Cash, cash equivalents and restricted cash | 227,583 | 92,901 | $ 93,633 | $ 309,421 |
Restricted cash | $ 1,700 | $ 1,700 | $ 1,700 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Estimated useful life (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 7 years |
Manufacturing equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 10 years |
Manufacturing facility | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 30 years |
Leasehold improvements | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 10 years |
Investments and Fair Value of_3
Investments and Fair Value of Financial Assets and Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Marketable securities | ||
Amortized Cost | $ 85,118 | |
Gross Unrealized Gains | 6 | |
Gross Unrealized Losses | (2) | |
Investments | $ 0 | 85,122 |
Assets: | ||
Investments | 0 | 85,122 |
Transfers between Level 1, Level 2 or Level 3 | ||
Transfers between Level 1, Level 2 and Level 3 | 0 | 0 |
Roll forward of aggregate fair values of preferred stock warrants | ||
Change in fair value through the exercise date | 0 | |
U.S. treasury bills and notes | ||
Marketable securities | ||
Amortized Cost | 85,118 | |
Gross Unrealized Gains | 6 | |
Gross Unrealized Losses | (2) | |
Investments | 85,122 | |
Assets: | ||
Investments | 85,122 | |
Recurring | ||
Assets: | ||
Assets | 217,009 | 173,936 |
Recurring | U.S. money market funds | ||
Assets: | ||
Cash equivalents | 217,009 | 88,814 |
Recurring | U.S. treasury bills and notes | ||
Marketable securities | ||
Investments | 85,122 | |
Assets: | ||
Investments | 85,122 | |
Recurring | Level 1 | ||
Assets: | ||
Assets | 217,009 | 88,814 |
Recurring | Level 1 | U.S. money market funds | ||
Assets: | ||
Cash equivalents | $ 217,009 | 88,814 |
Recurring | Level 2 | ||
Assets: | ||
Assets | 85,122 | |
Recurring | Level 2 | U.S. treasury bills and notes | ||
Marketable securities | ||
Investments | 85,122 | |
Assets: | ||
Investments | $ 85,122 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net (Details) $ in Thousands | Jul. 31, 2018USD ($)ft² | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | $ 69,386 | $ 64,085 | ||
Less: Accumulated depreciation and amortization | (17,856) | (10,133) | ||
Property, plant and equipment, net | 51,530 | 53,952 | ||
Depreciation and amortization expense | 7,700 | 5,700 | $ 3,000 | |
Land | ||||
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | 1,300 | 1,300 | ||
Manufacturing facility | ||||
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | 33,203 | 30,969 | ||
Square footing of facility acquired | ft² | 135,000 | |||
Purchases and additions | $ 8,000 | |||
Manufacturing equipment | ||||
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | 8,831 | 8,782 | ||
Laboratory equipment | ||||
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | 17,501 | 16,639 | ||
Computer equipment | ||||
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | 2,645 | 2,118 | ||
Furniture and fixtures | ||||
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | 1,281 | 1,228 | ||
Leasehold improvements | ||||
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | 444 | 444 | ||
Construction in progress | ||||
Property, Plant and Equipment, Net | ||||
Property, plant and equipment, gross | $ 4,181 | $ 2,605 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses and Other Current Liabilities | ||
Accrued employee compensation and benefits | $ 7,451 | $ 8,124 |
Accrued external research and development expenses | 2,713 | 3,156 |
Accrued manufacturing facility expenses | 2,349 | 339 |
Accrued general and administrative expenses | 889 | 1,244 |
Other | 670 | 554 |
Accrued expenses and other current liabilities | $ 14,072 | $ 13,417 |
Debt (Details)
Debt (Details) $ in Thousands | Jun. 22, 2021USD ($) | Dec. 21, 2018USD ($)tranche | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2021USD ($) |
Estimated future principal payments due | |||||
2024 | $ 18,750 | ||||
2024 | 37,500 | ||||
2025 and thereafter | 18,750 | ||||
Total debt | $ 75,000 | ||||
2018 Credit Facility | |||||
Debt | |||||
Number of tranche | tranche | 3 | ||||
Borrowing | $ 25,000 | $ 25,000 | $ 25,000 | ||
Maximum amount outstanding | $ 75,000 | ||||
Debt default interest rate addition (as a percent) | 4 | ||||
2018 Credit Facility | Term loan | |||||
Debt | |||||
Principal amount of each tranche of term loans | $ 25,000 | ||||
Principal Amount To Be Funded Per Tranche | |||||
Debt | |||||
Principal amount | $ 35,000 | ||||
2018 Credit Facility Amendment | |||||
Debt | |||||
Interest rate (as a percent) | 5.50% | ||||
One-month LIBOR | one-month | ||||
Prepayment fee in first year | 1.00% | ||||
Prepayment fee in second year | 0.50% | ||||
Prepayment fee in third year | 0.25% | ||||
2018 Credit Facility Amendment | Lenders | |||||
Debt | |||||
Issuance costs | $ 200 | ||||
2018 Credit Facility Amendment | Minimum | |||||
Debt | |||||
Variable interest rate | 2.10% | ||||
2018 Credit Facility Amendment | One-month U.S. LIBOR | |||||
Debt | |||||
Variable interest rate | 0.00% | ||||
2018 Credit Facility Amendment | One-month U.S. LIBOR | Maximum | |||||
Debt | |||||
Variable interest rate | 2.10% |
Debt - Current and Non current
Debt - Current and Non current (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt | ||
Principal amount of long-term debt | $ 75,000 | $ 75,000 |
Long term debt net of current maturities | 75,000 | 75,000 |
Accrued final interest payment | 1,654 | 408 |
Debt discount | (500) | (464) |
Longterm debt, net of discount and current portion | $ 76,154 | $ 74,944 |
Equity (Details)
Equity (Details) $ / shares in Units, $ in Thousands | Mar. 18, 2021USD ($)shares | Dec. 31, 2021USD ($)Vote$ / sharesshares | Dec. 31, 2019shares | Dec. 31, 2020$ / sharesshares | Aug. 01, 2019USD ($) | Jul. 20, 2018$ / sharesshares |
Equity | ||||||
Number of votes per share | Vote | 1 | |||||
Shares authorized | 160,000,000 | |||||
Common stock, authorized (in shares) | 150,000,000 | 150,000,000 | 150,000,000 | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||
Preferred stock, share authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||
Net proceeds after deducting underwriting discounts and commissions | $ | $ 188,000 | |||||
Common stock | ||||||
Equity | ||||||
Shares issued (in shares) | 6,896,552 | 1,449,309 | ||||
At the market offering | ||||||
Equity | ||||||
Aggregate offering price | $ | $ 100,000 | |||||
Percentage of commission | 3.00% | |||||
Shares issued (in shares) | 0 | |||||
Offering | ||||||
Equity | ||||||
Shares issued (in shares) | 6,896,552 | |||||
Net proceeds after deducting underwriting discounts and commissions | $ | $ 187,200 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - shares | Jan. 01, 2022 | Jul. 06, 2018 | Dec. 31, 2021 |
2018 Equity Incentive Plan | |||
Fair value of stock-based awards granted to employees, directors, and, in 2018, non-employees, subsequent to the adoption of ASU 2018-07 | |||
Total number of shares of common stock authorized to issue | 5,708,931 | ||
Number of shares remained available for future issuance | 3,290,353 | ||
Annual increase of shares reserved for awards (as a percent) | 4.00% | ||
Increase in number of authorized shares reserved for issuance | 3,152,231 | ||
2018 Employee Stock Purchase Plan | |||
Fair value of stock-based awards granted to employees, directors, and, in 2018, non-employees, subsequent to the adoption of ASU 2018-07 | |||
Total number of shares of common stock authorized to issue | 951,488 | ||
Number of shares remained available for future issuance | 1,717,392 | ||
Annual increase of shares reserved for awards (as a percent) | 1.00% | ||
Annual increase of shares reserved for awards if less than 1% of the outstanding stock | 951,488 | ||
Increase in number of authorized shares reserved for issuance | 0 |
Stock-Based Compensation - Gran
Stock-Based Compensation - Granted to non-employees, prior to the adoption of ASU 2018-07 (Details) - Non-employees | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Fair value of stock awards granted prior to the adoption of ASU 2018-07 | |||
Risk-free interest rate | 0.81% | 1.10% | 2.07% |
Expected volatility | 77.40% | 69.40% | 76.90% |
Expected term (in years) | 6 years 29 days | 6 years 18 days | 6 years 21 days |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option activity (Details) - Stock options. - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of shares | |||
Outstanding at beginning of period | 15,960,324 | ||
Options granted | 4,138,080 | ||
Exercised | (1,933,523) | ||
Forfeited | (1,026,109) | ||
Outstanding at end of period | 17,138,772 | 15,960,324 | |
Vested and expected to vest as of December 31, 2020 | 17,138,772 | ||
Options exercisable as of December 31, 2020 | 10,554,855 | ||
Weighted average exercise price | |||
Outstanding at the beginning (in dollars per share) | $ 10.17 | ||
Granted (in dollars per share) | 15.80 | ||
Exercised (in dollars per share) | 5.53 | ||
Forfeited (in dollars per share) | 10.37 | ||
Outstanding at the end (in dollars per share) | 12.04 | $ 10.17 | |
Vested and expected to vest (in dollars per share) | 12.04 | ||
Options exercisable (in dollars per share | $ 11.52 | ||
Weighted average contractual term and aggregate intrinsic value | |||
Outstanding at the beginning (in years) | 7 years 2 months 19 days | 7 years 4 months 17 days | |
Outstanding at the end (in years) | 7 years 2 months 19 days | 7 years 4 months 17 days | |
Vested and expected to vest (in years) | 7 years 2 months 19 days | ||
Options exercisable (in years) | 6 years 5 months 1 day | ||
Outstanding at the beginning (in dollars) | $ 15,018 | ||
Outstanding at the end (in dollars) | 23,511 | $ 15,018 | |
Vested and expected to vest (in dollars) | 23,511 | ||
Options exercisable (in dollars) | $ 18,126 | ||
Weighted average grant-date fair value (per share) | $ 10.55 | $ 4.51 | $ 8.58 |
Aggregate intrinsic value of stock options exercised | $ 34,600 | $ 5,700 | $ 17,700 |
Stock-Based Compensation - Perf
Stock-Based Compensation - Performance based stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-Based Compensation | ||||
Proceeds from issuance of common stock upon exercise of stock options | $ 10,963 | $ 1,484 | $ 2,413 | |
Stock-based compensation expense | $ 35,610 | $ 33,665 | $ 41,271 | |
Market-Based Stock Options | ||||
Stock-Based Compensation | ||||
Options granted | 0 | 0 | 0 | |
Issuance of common stock upon exercise of stock options (in shares) | 0 | 0 | 0 | |
Aggregate intrinsic value of stock options exercised | $ 0 | |||
Market based and service based vesting | ||||
Stock-Based Compensation | ||||
Stock-based compensation expense | 200 | $ 600 | $ 900 | |
Market based and service based vesting | Executive officer | ||||
Stock-Based Compensation | ||||
Options granted | 164,400 | |||
Options exercise price | $ 16.43 | |||
Performance-based vesting | ||||
Stock-Based Compensation | ||||
Stock-based compensation expense | 1,100 | $ 1,100 | $ 0 | |
Executive officer | ||||
Stock-Based Compensation | ||||
Options granted | 193,400 | |||
Options exercise price | $ 16.43 | |||
Stock-based compensation, fair value | $ 4,300 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Common Stock (Details) - $ / shares | 1 Months Ended | 12 Months Ended |
Oct. 31, 2018 | Dec. 31, 2021 | |
Executive officer | ||
Weighted Average Grant Date Fair Value | ||
Restricted stock exercise price | $ 16.43 | |
Restricted Stock Units | ||
Number of shares | ||
Unvested restricted common stock beginning of period | 252,000 | |
Issued | 787,107 | |
Vested | (153,600) | |
Forfeited | (91,263) | |
Unvested restricted common stock end of period | 794,244 | |
Weighted Average Grant Date Fair Value | ||
Weighted Average Grant Date Fair Value - beginning of the period (in dollars per share) | $ 10.660 | |
Weighted Average Grant Date Fair Value- issued (in dollars per share) | 15.505 | |
Weighted Average Grant Date Fair Value- vested (in dollars per share) | 10.660 | |
Weighted Average Grant Date Fair Value- Forfeited (in dollars per share) | 11.660 | |
Weighted Average Grant Date Fair Value - End of the period (in dollars per share) | $ 15.346 | |
Restricted Stock Units | Maximum | ||
Weighted Average Grant Date Fair Value | ||
Vesting period | 4 years | |
Restricted Stock Units | Minimum | ||
Weighted Average Grant Date Fair Value | ||
Vesting period | 3 years |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-based compensation expense | |||
Stock-based compensation expense | $ 35,610 | $ 33,665 | $ 41,271 |
Research and development expense | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 12,338 | 8,023 | 9,011 |
General and administrative expense | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 23,272 | $ 25,642 | $ 32,260 |
Stock options. | |||
Stock-based compensation expense | |||
Unrecognized compensation cost | $ 57,300 | ||
Unrecognized compensation cost expected to be recognized over a weighted average period | 2 years 6 months |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
Federal Operating loss carryforwards | $ 534,200 | |
State Operating loss carryforwards | 534,800 | |
Federal Operating loss carryforwards subject to expiration | 37,200 | |
Federal Operating loss carryforwards subject to expiration indefinitely | 497,000 | |
Research and development tax credit carryforwards | 36,161 | $ 23,524 |
Increase in gross deferred tax assets, before valuation allowance | 65,800 | |
Accrued interest or penalties | 0 | 0 |
Uncertain tax positions | 0 | $ 0 |
U.S. federal | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credit carryforwards | 22,700 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credit carryforwards | $ 15,600 |
Income Taxes - U S federal stat
Income Taxes - U S federal statutory income tax rate (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | |||
Income tax benefits - operating losses incurred | $ 0 | $ 0 | $ 0 |
Federal statutory income tax rate | (21.00%) | (21.00%) | |
State taxes, net of federal benefit | (6.20%) | (6.20%) | |
Federal and state research and development tax credits | (6.40%) | (5.90%) | |
Stock-based compensation expense | (1.60%) | 0.40% | |
Section 162(m) compensation deduction limitation | 1.60% | ||
Other | (0.40%) | 0.50% | |
Increase in deferred tax asset valuation allowance | 34.00% | 32.20% |
Income Taxes - Net deferred tax
Income Taxes - Net deferred tax assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||||
Net operating loss carryforwards | $ 145,990 | $ 97,791 | ||
Research and development tax credit carryforwards | 36,161 | 23,524 | ||
Accrued expenses | 2,137 | 2,241 | ||
Capitalized intellectual property costs | 1,746 | 1,123 | ||
Capitalized research and development expense | 86 | 97 | ||
Operating lease liabilities | 10,194 | 11,394 | ||
Stock-based compensation expense | 21,483 | 15,847 | ||
Total deferred tax assets | 217,797 | 152,017 | ||
Deferred tax liabilities: | ||||
Operating lease assets | (9,590) | (11,050) | ||
Depreciation and other | (1,500) | (1,090) | ||
Total deferred tax liabilities | (11,090) | (12,140) | ||
Valuation allowance | $ (206,707) | $ (139,877) | $ (85,884) | $ (33,666) |
Income Taxes - Valuation allowa
Income Taxes - Valuation allowance for deferred tax assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | |||
Valuation allowance as of beginning of year | $ 139,877 | $ 85,884 | $ 33,666 |
Increases recorded to income tax provision | 66,830 | 53,993 | 52,218 |
Valuation allowance as of end of year | $ 206,707 | $ 139,877 | $ 85,884 |
Commitments and Contingencies -
Commitments and Contingencies - Collaborative Arrangements and Non-collaborative Arrangement (Details) - WIBR $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement | |
Aggregate milestone payments | $ 1.6 |
Maximum | License maintenance fees | |
Collaborative Arrangements and Non-collaborative Arrangement | |
License costs | $ 0.1 |
Commitments and Contingencies_2
Commitments and Contingencies - Defined Contribution Plan (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies | ||||
Employer matching contribution (as a percent) | 50.00% | |||
Company matching contribution | $ 0.9 | $ 0.8 | $ 0.6 | |
Maximum | ||||
Commitments and Contingencies | ||||
Percentage of employee's gross pay match | 6.00% |
Leases (Details)
Leases (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2018USD ($) | Jan. 31, 2018USD ($)Options | Dec. 31, 2021USD ($)itemleaseproperty | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($) | |
Leases | |||||
Number of leases | lease | 2 | ||||
Number of expiration period | item | 2 | ||||
Number of leased properties | property | 2 | ||||
Lease term | 9 years | 8 years | |||
Extended lease term | 5 years | ||||
Number of options to renew lease | Options | 1 | ||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||||
Initial annual base rent | $ 2,500 | $ 3,800 | |||
Base rent incremental (as a percentage) | 3.00% | 3.00% | |||
Benefit of the landlord secured by cash deposit | $ 600 | $ 900 | |||
Tenant improvement allowance | 9,200 | 9,400 | |||
Tenant improvement repayable to landlord | $ 2,000 | $ 500 | |||
Operating lease, right-of-use-asset | $ 35,095 | $ 46,559 | $ 40,447 | ||
Embedded lease contracts | |||||
Leases | |||||
Lease term | 22 months | ||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | false |
Leases - Minimum lease payments
Leases - Minimum lease payments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Minimum lease payments | |
2022 | $ 9,015 |
2023 | 7,447 |
2024 | 7,601 |
2025 | 7,818 |
2026 | 8,041 |
Thereafter | 6,199 |
Payments due | 46,121 |
Less: imputed interest | (8,815) |
Operating lease liability | $ 37,306 |
Leases - Lease Portfolio (Detai
Leases - Lease Portfolio (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Lease Cost | |||
Operating lease cost | $ 8,173 | $ 9,240 | $ 7,208 |
Short-term lease cost | 41 | 24 | 127 |
Variable lease cost | 3,723 | 1,916 | 1,976 |
Sublease income | (719) | (1,017) | (908) |
Total lease cost | 11,218 | 10,163 | 8,403 |
Operating Leases | |||
Operating lease, right-of-use-asset | 35,095 | 40,447 | 46,559 |
Operating lease liabilities | 9,015 | 8,945 | 10,540 |
Operating lease liabilities, net of current portion | $ 28,291 | $ 32,762 | $ 36,867 |
Weighted average remaining lease term - operating leases | 5 years 9 months 18 days | 6 years 8 months 12 days | 7 years 5 months 19 days |
Weighted-average discount rate - operating leases | 7.60% | 7.60% | 7.58% |
Net Loss per Share - Weighted A
Net Loss per Share - Weighted Average Shares (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | |||
Net Loss | $ (196,547) | $ (167,731) | $ (163,458) |
Denominator: | |||
Weighted average common shares outstanding, basic and diluted | 87,950,440 | 80,624,608 | 78,688,878 |
Net loss per share, basic and diluted | $ (2.23) | $ (2.08) | $ (2.08) |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive Securities (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Diluted net loss per share attributable to common stockholders | |||
Antidilutive securities excluded from computation of of diluted weighted average shares outstanding | 18,290,816 | 16,570,124 | 15,480,421 |
Unvested restricted common stock | |||
Diluted net loss per share attributable to common stockholders | |||
Antidilutive securities excluded from computation of of diluted weighted average shares outstanding | 794,244 | 252,000 | 376,514 |
Stock options to purchase common stock | |||
Diluted net loss per share attributable to common stockholders | |||
Antidilutive securities excluded from computation of of diluted weighted average shares outstanding | 17,496,572 | 16,318,124 | 15,103,907 |