Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 29, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
Document Transition Report | false | |
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 $0.001 per share | |
Trading Symbol | RUBY | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 90,357,032 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001709401 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 62,211,000 | $ 225,848,000 |
Investments | 78,502,000 | 0 |
Prepaid expenses and other current assets | 2,779,000 | 3,975,000 |
Total current assets | 143,492,000 | 229,823,000 |
Operating lease, right-of-use-asset | 32,548,000 | 35,095,000 |
Property, plant and equipment, net | 51,469,000 | 51,530,000 |
Restricted cash | 1,573,000 | 1,573,000 |
Total assets | 229,082,000 | 318,021,000 |
Current liabilities: | ||
Accounts payable | 12,435,000 | 11,572,000 |
Accrued expenses and other current liabilities | 9,407,000 | 14,072,000 |
Operating lease liabilities | 9,149,000 | 9,015,000 |
Total current liabilities | 30,991,000 | 34,659,000 |
Long-term debt, net of discount | 76,602,000 | 76,154,000 |
Other long-term liabilities | 67,000 | 135,000 |
Operating lease liabilities, net of current portion | 25,882,000 | 28,291,000 |
Total liabilities | 133,542,000 | 139,239,000 |
Commitments and contingencies (see Note 9) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2022 and December 31, 2021; no shares issued or outstanding at June 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.001 par value; 150,000,000 shares authorized at June 30, 2022 and December 31, 2021; 90,357,032 and 90,063,770 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 90,000 | 90,000 |
Additional paid-in capital | 869,243,000 | 855,710,000 |
Accumulated other comprehensive loss | (122,000) | 0 |
Accumulated deficit | (773,671,000) | (677,018,000) |
Total stockholders' equity | 95,540,000 | 178,782,000 |
Total liabilities and stockholders' equity | $ 229,082,000 | $ 318,021,000 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
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) | 90,357,032 | 90,063,770 |
Common stock, shares outstanding (in shares) | 90,357,032 | 90,063,770 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 32,998 | 36,072 | 71,297 | 63,749 |
General and administrative | 9,908 | 13,851 | 22,471 | 27,091 |
Total operating expenses | 42,906 | 49,923 | 93,768 | 90,840 |
Loss from operations | (42,906) | (49,923) | (93,768) | (90,840) |
Other income (expense): | ||||
Interest income | 255 | 26 | 303 | 52 |
Interest expense | (1,630) | (1,312) | (3,259) | (3,060) |
Other income, net | 40 | 1,029 | 71 | 1,338 |
Total other income (expense), net | (1,335) | (257) | (2,885) | (1,670) |
Net loss | $ (44,241) | $ (50,180) | $ (96,653) | $ (92,510) |
Net loss per share, diluted (in dollars per share) | $ (0.49) | $ (0.56) | $ (1.07) | $ (1.08) |
Net loss per share, basic (in dollars per share) | $ (0.49) | $ (0.56) | $ (1.07) | $ (1.08) |
Weighted-average common shares outstanding, basic (in shares) | 90,257,524 | 89,517,784 | 90,203,586 | 85,936,079 |
Weighted-average common shares outstanding, diluted (in shares) | 90,257,524 | 89,517,784 | 90,203,586 | 85,936,079 |
Comprehensive loss: | ||||
Net loss | $ (44,241) | $ (50,180) | $ (96,653) | $ (92,510) |
Other comprehensive income (loss): | ||||
Unrealized losses on investments, net of tax of $0 | (65) | (6) | (122) | (3) |
Comprehensive loss | $ (44,306) | $ (50,186) | $ (96,775) | $ (92,513) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Unrealized gains (losses) on investments, tax | $ 0 | $ 0 | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (96,653) | $ (92,510) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 13,301 | 18,239 |
Depreciation and amortization expense | 3,158 | 3,012 |
Amortization (accretion) of premium (discount) on investments | (179) | 110 |
Non-cash interest expense | 394 | 807 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 1,034 | (821) |
Operating lease, right-of-use-asset | 2,547 | 2,729 |
Accounts payable | 638 | (171) |
Accrued expenses and other current liabilities | (3,318) | (2,466) |
Other long-term liabilities | (68) | (68) |
Operating lease liabilities | (2,275) | (2,320) |
Net cash used in operating activities | (81,421) | (73,459) |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment | (4,165) | (1,591) |
Purchases of investments | (78,445) | 0 |
Sales and maturities of investments | 0 | 70,000 |
Net cash provided by (used in) investing activities | (82,610) | 68,409 |
Cash flows from financing activities: | ||
Proceeds from underwritten public offering of common stock, net of commissions and underwriting discounts | 0 | 188,000 |
Payments of offering costs | 0 | (360) |
Payments of debt issuance costs | 0 | (150) |
Proceeds from issuance of common stock upon exercise of stock options and under employee stock purchase plan | 232 | 9,628 |
Net cash provided by financing activities | 232 | 197,118 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (163,799) | 192,068 |
Cash, cash equivalents and restricted cash at beginning of period | 227,583 | 92,901 |
Cash, cash equivalents and restricted cash at end of period | 63,784 | 284,969 |
Supplemental cash flow information: | ||
Cash paid for interest | 2,865 | 1,917 |
Cash paid for leases | 3,599 | 3,806 |
Supplemental disclosure of non-cash investing and financing information: | ||
Purchases of property, plant and equipment included in accounts payable or accrued expenses | 868 | 288 |
Offering costs included in accounts payable and accrued expenses | $ 0 | $ 35 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive income (loss) | Accumulated deficit |
Balances at beginning of period (in shares) at Dec. 31, 2020 | 81,053,651 | ||||
Balances at beginning of period at Dec. 31, 2020 | $ 141,560 | $ 81 | $ 621,946 | $ 4 | $ (480,471) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock from public offering, net of commissions, underwriting discounts and offering costs (in shares) | 6,896,552 | ||||
Issuance of common stock from public offering, net of commissions, underwriting discounts and offering costs of $800 | 187,200 | $ 7 | 187,193 | ||
Issuance of common stock upon exercise of stock options (in shares) | 1,237,324 | ||||
Issuance of common stock upon exercise of stock options | 5,908 | $ 1 | 5,907 | ||
Stock-based compensation expense | 8,642 | 8,642 | |||
Unrealized gain (loss) on investments | 3 | 3 | |||
Net loss | (42,330) | (42,330) | |||
Balances at end of period (in shares) at Mar. 31, 2021 | 89,187,527 | ||||
Balances at end of period at Mar. 31, 2021 | 300,983 | $ 89 | 823,688 | 7 | (522,801) |
Balances at beginning of period (in shares) at Dec. 31, 2020 | 81,053,651 | ||||
Balances at beginning of period at Dec. 31, 2020 | 141,560 | $ 81 | 621,946 | 4 | (480,471) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (92,510) | ||||
Balances at end of period (in shares) at Jun. 30, 2021 | 89,719,927 | ||||
Balances at end of period at Jun. 30, 2021 | 264,114 | $ 90 | 837,004 | 1 | (572,981) |
Balances at beginning of period (in shares) at Mar. 31, 2021 | 89,187,527 | ||||
Balances at beginning of period at Mar. 31, 2021 | 300,983 | $ 89 | 823,688 | 7 | (522,801) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 532,400 | ||||
Issuance of common stock upon exercise of stock options | 3,720 | $ 1 | 3,719 | ||
Stock-based compensation expense | 9,597 | 9,597 | |||
Unrealized gain (loss) on investments | (6) | (6) | |||
Net loss | (50,180) | (50,180) | |||
Balances at end of period (in shares) at Jun. 30, 2021 | 89,719,927 | ||||
Balances at end of period at Jun. 30, 2021 | 264,114 | $ 90 | 837,004 | 1 | (572,981) |
Balances at beginning of period (in shares) at Dec. 31, 2021 | 90,063,770 | ||||
Balances at beginning of period at Dec. 31, 2021 | 178,782 | $ 90 | 855,710 | 0 | (677,018) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 18,228 | ||||
Issuance of common stock upon exercise of stock options | 76 | 76 | |||
Vesting of restricted stock units | 0 | ||||
Vesting of restricted stock units (in shares) | 104,628 | ||||
Stock-based compensation expense | 8,260 | 8,260 | |||
Unrealized gain (loss) on investments | (57) | (57) | |||
Net loss | (52,412) | (52,412) | |||
Balances at end of period (in shares) at Mar. 31, 2022 | 90,186,626 | ||||
Balances at end of period at Mar. 31, 2022 | 134,649 | $ 90 | 864,046 | (57) | (729,430) |
Balances at beginning of period (in shares) at Dec. 31, 2021 | 90,063,770 | ||||
Balances at beginning of period at Dec. 31, 2021 | 178,782 | $ 90 | 855,710 | 0 | (677,018) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (96,653) | ||||
Balances at end of period (in shares) at Jun. 30, 2022 | 90,357,032 | ||||
Balances at end of period at Jun. 30, 2022 | 95,540 | $ 90 | 869,243 | (122) | (773,671) |
Balances at beginning of period (in shares) at Mar. 31, 2022 | 90,186,626 | ||||
Balances at beginning of period at Mar. 31, 2022 | 134,649 | $ 90 | 864,046 | (57) | (729,430) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 24,000 | ||||
Issuance of common stock upon exercise of stock options | 22 | 22 | |||
Vesting of restricted stock units | 0 | ||||
Vesting of restricted stock units (in shares) | 2,500 | ||||
Stock issued during period, shares, employee stock purchase plans (in shares) | 143,906 | ||||
Issuance of common stock under employee stock purchase plan | 134 | 134 | |||
Stock-based compensation expense | 5,041 | 5,041 | |||
Unrealized gain (loss) on investments | (65) | (65) | |||
Net loss | (44,241) | (44,241) | |||
Balances at end of period (in shares) at Jun. 30, 2022 | 90,357,032 | ||||
Balances at end of period at Jun. 30, 2022 | $ 95,540 | $ 90 | $ 869,243 | $ (122) | $ (773,671) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2021 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Stock issuance costs | $ 800 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Basis of Presentation | Nature of the Business and Basis of Presentation Rubius Therapeutics, Inc. (“Rubius” or the “Company”) is a biopharmaceutical company that is biologically engineering 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. The 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 Company’s current financial resources and currently forecasted operating plan would allow the Company to operate into the second half of 2023. The Company has developed plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations and reducing cash expenditures. If the Company is not able to secure adequate additional funding, the Company plans to make reductions in spending. In that event, the Company may have to delay, scale back, or eliminate some or all of the Company’s research and development programs and technology platform activities which could adversely affect its business prospects, or the Company may be unable to continue operations. Under Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40) (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the financial statements are issued. As of June 30, 2022, the Company had an accumulated deficit of $773.7 million, and cash, cash equivalents and investments of $140.7 million. For the six months ended June 30, 2022 , the Company incurred a loss of $96.7 million and used $81.4 million of cash in operations. The Company expects that its operating losses and negative cash flows will continue for the foreseeable future. Management has assessed the Company’s ability to continue as a going concern in accordance with the requirements of ASC 205-40 and based on its recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future, and the need to raise additional capital to finance its future operations, as of August 9, 2022, the issuance date of the interim condensed consolidated financial statements for the three and six month periods ended June 30, 2022, the Company has concluded that there is substantial doubt about its ability to continue as a going concern for a period of one year from the date that these condensed consolidated financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Unaudited Interim Financial Information The condensed consolidated balance sheet at December 31, 2021 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year-ended December 31, 2021, on file with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of June 30, 2022 and condensed consolidated results of operations for the three and six months ended June 30, 2022 and 2021 and the condensed consolidated cash flows for the six months ended June 30, 2022 and 2021 have been made. The Company’s condensed consolidated results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022. 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 condensed 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 ongoing 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. As of the date of issuance of these unaudited condensed consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions. 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, cash equivalents and investments, as of June 30, 2022, consisted of cash, money market accounts, U.S. government money market funds and U.S. government treasury bills. 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. 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 June 30, 2022 and December 31, 2021, the Company maintained letters of credit for the benefit of the landlords of its leased properties totaling $1.6 million and $1.7 million, respectively. 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 $1.6 million in restricted cash (non-current) in its condensed consolidated balance sheet as of June 30, 2022. As of December 31, 2021, the Company included $0.1 million in prepaid expenses and other current assets and $1.6 million in restricted cash (non-current) in its condensed consolidated balance sheet. Cash, cash equivalents and restricted cash presented in the accompanying condensed consolidated statement of cash flows was $63.8 million and $285.0 million for the six months ended June 30, 2022 and 2021, respectively, of which $1.6 million and $1.7 million was restricted cash, respectively. 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 condensed 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. 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 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. |
Investments and Fair Value of F
Investments and Fair Value of Financial Assets and Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Investments and Fair Value of Financial Assets and Liabilities | Investments and Fair Value of Financial Assets and Liabilities As of June 30, 2022, investments by security type consisted of the following (in thousands): June 30, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Credit Losses Fair Value U.S. treasury bills (due within one year) $ 78,624 $ — $ (122) $ — $ 78,502 $ 78,624 $ — $ (122) $ — $ 78,502 The Company had no investments as of December 31, 2021. 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 June 30, 2022 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S. government money market funds $ 56,804 $ — $ — $ 56,804 Investments: U.S. government treasury bills — 78,502 — 78,502 $ 56,804 $ 78,502 $ — $ 135,306 Fair value measurements at December 31, 2021 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S government money market funds $ 217,009 $ — $ — $ 217,009 $ 217,009 $ — $ — $ 217,009 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. government treasury bills 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 six months ended June 30, 2022. 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 six months ended June 30, 2022. |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment, Net [Abstract] | |
Property, Plant and Equipment, Net | Property, Plant and Equipment, Net Property, plant and equipment, net consisted of the following (in thousands): June 30, 2022 December 31, 2021 Land $ 1,300 $ 1,300 Manufacturing facility 36,631 33,203 Manufacturing equipment 9,492 8,831 Laboratory equipment 18,191 17,501 Computer equipment 2,824 2,645 Furniture and fixtures 1,306 1,281 Leasehold improvements 570 444 Construction-in-progress 2,169 4,181 72,483 69,386 Less: Accumulated depreciation and amortization (21,014) (17,856) $ 51,469 $ 51,530 During the six months ended June 30, 2022, the Company placed into service $4.1 million of property, plant and equipment related to renovations to expand the Smithfield, Rhode Island manufacturing facility’s production capacity and operating capabilities. As of December 31, 2021, these additions were not ready for their intended use and continued to be included in construction-in-progress. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2022 December 31, 2021 Accrued employee compensation and benefits $ 3,849 $ 7,451 Accrued external research and development expenses 3,686 2,713 Accrued manufacturing facility expenses 589 2,349 Accrued general and administrative expenses 688 889 Other 595 670 $ 9,407 $ 14,072 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | DebtOn December 21, 2018 (the “Closing Date”), the Company entered into a loan and security agreement (the "Original Loan Agreement," and, as amended, the “Loan Agreement”) with Solar Capital Ltd., now SLR Investment Corp., as collateral agent for the lenders party thereto for an aggregate principal amount of $75.0 million. The aggregate principal amount was 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 the Original 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 Original 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 minimum cash balance of $10.0 million plus accounts payable that are aged longer than ninety days or a minimum market capitalization threshold. The Company was in compliance with all such financial covenants as of June 30, 2022. The Loan Agreement contains customary representations, warranties and covenants and also includes customary events of default, including payment defaults, breaches of covenants, change of control and a material adverse change default. Upon the occurrence of an event of default, a default interest rate of an additional 4.00% per annum may be applied to the outstanding loan balances, and the lenders may declare all outstanding obligations immediately due and payable. Borrowings under the Loan Agreement are collateralized by substantially all of the Company’s assets, other than its intellectual property. As of June 30, 2022, the estimated future principal payments due were as follows (in thousands): Year ending December 31, 2022 (six months ending December 31) $ — 2023 — 2024 18,750 2025 37,500 2026 and thereafter 18,750 $ 75,000 |
Equity
Equity | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Equity | 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 and ceased to be effective on June 21, 2022. As of June 30, 2022, no shares of common stock have been issued and sold pursuant to the Distribution Agreement and none are expected to be sold because the applicable registration statement is no longer effective. The Distribution Agreement will expire in accordance with its terms on August 21, 2022. 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. On July 7, 2022, the Company filed an amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware which increased the number of shares of common stock that the Company has authority to issue from 150,000,000 to 300,000,000 shares. The number of shares of preferred stock authorized for issuance was not impacted by this amendment. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Service-Based Stock Options During the six months ended June 30, 2022, the Company granted options with service-based vesting conditions for the purchase of 3,218,103 shares of common stock with a weighted average exercise price of $5.44 per share and a weighted average grant-date fair value of $3.71 per share. Stock-Based Compensation The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development expenses $ 2,215 $ 3,056 $ 5,692 $ 5,587 General and administrative expenses 2,826 6,541 7,609 12,652 $ 5,041 $ 9,597 $ 13,301 $ 18,239 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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 (as amended, 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 three and six months ended June 30, 2022, the Company made matching contributions of $0.2 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. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Net Loss per Share Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Numerator: Net loss $ (44,241) $ (50,180) $ (96,653) $ (92,510) Denominator: Weighted average common shares outstanding, basic and diluted 90,257,524 89,517,784 90,203,586 85,936,079 Net loss per share, basic and diluted $ (0.49) $ (0.56) $ (1.07) $ (1.08) 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: June 30, 2022 2021 Unvested restricted common stock 1,413,369 708,668 Stock options to purchase common stock 19,207,827 17,195,305 20,621,196 17,903,973 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The condensed consolidated balance sheet at December 31, 2021 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year-ended December 31, 2021, on file with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of June 30, 2022 and condensed consolidated results of operations for the three and six months ended June 30, 2022 and 2021 and the condensed consolidated cash flows for the six months ended June 30, 2022 and 2021 have been made. The Company’s condensed consolidated results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022. |
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 condensed 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 ongoing 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. As of the date of issuance of these unaudited condensed consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions. |
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, cash equivalents and investments, as of June 30, 2022, consisted of cash, money market accounts, U.S. government money market funds and U.S. government treasury bills. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. |
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 June 30, 2022 and December 31, 2021, the Company maintained letters of credit for the benefit of the landlords of its leased properties totaling $1.6 million and $1.7 million, respectively. 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 $1.6 million in restricted cash (non-current) in its condensed consolidated balance sheet as of June 30, 2022. As of December 31, 2021, the Company included $0.1 million in prepaid expenses and other current assets and $1.6 million in restricted cash (non-current) in its condensed consolidated balance sheet. |
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 condensed 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. 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 |
Leases | Leases 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. |
Investments and Fair Value of_2
Investments and Fair Value of Financial Assets and Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of investments by security type | As of June 30, 2022, investments by security type consisted of the following (in thousands): June 30, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Credit Losses Fair Value U.S. treasury bills (due within one year) $ 78,624 $ — $ (122) $ — $ 78,502 $ 78,624 $ — $ (122) $ — $ 78,502 |
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 June 30, 2022 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S. government money market funds $ 56,804 $ — $ — $ 56,804 Investments: U.S. government treasury bills — 78,502 — 78,502 $ 56,804 $ 78,502 $ — $ 135,306 Fair value measurements at December 31, 2021 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: U.S government money market funds $ 217,009 $ — $ — $ 217,009 $ 217,009 $ — $ — $ 217,009 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment, Net [Abstract] | |
Schedule of property, plant and equipment, net | Property, plant and equipment, net consisted of the following (in thousands): June 30, 2022 December 31, 2021 Land $ 1,300 $ 1,300 Manufacturing facility 36,631 33,203 Manufacturing equipment 9,492 8,831 Laboratory equipment 18,191 17,501 Computer equipment 2,824 2,645 Furniture and fixtures 1,306 1,281 Leasehold improvements 570 444 Construction-in-progress 2,169 4,181 72,483 69,386 Less: Accumulated depreciation and amortization (21,014) (17,856) $ 51,469 $ 51,530 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2022 December 31, 2021 Accrued employee compensation and benefits $ 3,849 $ 7,451 Accrued external research and development expenses 3,686 2,713 Accrued manufacturing facility expenses 589 2,349 Accrued general and administrative expenses 688 889 Other 595 670 $ 9,407 $ 14,072 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of estimated future principal payments due | As of June 30, 2022, the estimated future principal payments due were as follows (in thousands): Year ending December 31, 2022 (six months ending December 31) $ — 2023 — 2024 18,750 2025 37,500 2026 and thereafter 18,750 $ 75,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of allocation of share based compensation | The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development expenses $ 2,215 $ 3,056 $ 5,692 $ 5,587 General and administrative expenses 2,826 6,541 7,609 12,652 $ 5,041 $ 9,597 $ 13,301 $ 18,239 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of calculation of basic and diluted net loss per share attributable to common stockholders | Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Numerator: Net loss $ (44,241) $ (50,180) $ (96,653) $ (92,510) Denominator: Weighted average common shares outstanding, basic and diluted 90,257,524 89,517,784 90,203,586 85,936,079 Net loss per share, basic and diluted $ (0.49) $ (0.56) $ (1.07) $ (1.08) |
Schedule of dilutive securities excluded from computations of diluted weighted average shares outstanding | 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: June 30, 2022 2021 Unvested restricted common stock 1,413,369 708,668 Stock options to purchase common stock 19,207,827 17,195,305 20,621,196 17,903,973 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||
Mar. 18, 2021 | Jul. 20, 2018 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Nature of the business and basis of presentation | |||||||||
Proceeds from issuance of common stock | $ 0 | $ 188,000 | |||||||
Accumulated deficit | $ 773,671 | 773,671 | $ 677,018 | ||||||
Cash, cash equivalents, and short-term investments | 140,700 | 140,700 | |||||||
Net loss | $ 44,241 | $ 52,412 | $ 50,180 | $ 42,330 | 96,653 | 92,510 | |||
Net cash (used in) operating activities | $ (81,421) | $ (73,459) | |||||||
Common stock | |||||||||
Nature of the business and basis of presentation | |||||||||
Shares issued (in shares) | 6,896,552 | ||||||||
Conversion of redeemable convertible preferred stock to common stock (in shares) | 51,845,438 | ||||||||
IPO | |||||||||
Nature of the business and basis of presentation | |||||||||
Shares issued (in shares) | 12,055,450 | ||||||||
Net proceeds after deducting underwriting discounts and commissions | $ 254,300 | ||||||||
Overallotment | |||||||||
Nature of the business and basis of presentation | |||||||||
Shares issued (in shares) | 1,572,450 | ||||||||
Offering | |||||||||
Nature of the business and basis of presentation | |||||||||
Shares issued (in shares) | 6,896,552 | ||||||||
Net proceeds after deducting underwriting discounts and commissions | $ 187,200 | ||||||||
Proceeds from issuance of common stock | $ 187,200 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||||
Restricted cash for the benefit of its leased properties | $ 1,600 | $ 1,700 | ||
Restricted cash (non-current) | 1,573 | 1,573 | ||
Restricted cash, current | 100 | |||
Cash, cash equivalents and restricted cash | 63,784 | $ 227,583 | $ 284,969 | $ 92,901 |
Restricted cash | $ 1,600 | $ 1,700 |
Investments and Fair Value of_3
Investments and Fair Value of Financial Assets and Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Marketable securities | ||
Amortized Cost | $ 78,624 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (122) | |
Credit Losses | 0 | |
Investments | 78,502 | $ 0 |
Assets: | ||
Investments | 78,502 | 0 |
U.S. government treasury bills | ||
Marketable securities | ||
Amortized Cost | 78,624 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (122) | |
Credit Losses | 0 | |
Investments | 78,502 | |
Assets: | ||
Investments | 78,502 | |
Recurring | ||
Assets: | ||
Assets | 135,306 | 217,009 |
Recurring | U.S. government money market funds | ||
Assets: | ||
Cash equivalents | 56,804 | 217,009 |
Recurring | U.S. government treasury bills | ||
Marketable securities | ||
Investments | 78,502 | |
Assets: | ||
Investments | 78,502 | |
Recurring | Level 1 | ||
Assets: | ||
Assets | 56,804 | 217,009 |
Recurring | Level 1 | U.S. government money market funds | ||
Assets: | ||
Cash equivalents | 56,804 | 217,009 |
Recurring | Level 1 | U.S. government treasury bills | ||
Marketable securities | ||
Investments | 0 | |
Assets: | ||
Investments | 0 | |
Recurring | Level 2 | ||
Assets: | ||
Assets | 78,502 | 0 |
Recurring | Level 2 | U.S. government money market funds | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Recurring | Level 2 | U.S. government treasury bills | ||
Marketable securities | ||
Investments | 78,502 | |
Assets: | ||
Investments | 78,502 | |
Recurring | Level 3 | ||
Assets: | ||
Assets | 0 | 0 |
Recurring | Level 3 | U.S. government money market funds | ||
Assets: | ||
Cash equivalents | 0 | $ 0 |
Recurring | Level 3 | U.S. government treasury bills | ||
Marketable securities | ||
Investments | 0 | |
Assets: | ||
Investments | $ 0 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | $ 72,483 | $ 69,386 |
Less: Accumulated depreciation and amortization | (21,014) | (17,856) |
Property, plant and equipment, net | 51,469 | 51,530 |
Property, plant and equipment, additions | 4,100 | |
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 | 36,631 | 33,203 |
Manufacturing equipment | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 9,492 | 8,831 |
Laboratory equipment | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 18,191 | 17,501 |
Computer equipment | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 2,824 | 2,645 |
Furniture and fixtures | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 1,306 | 1,281 |
Leasehold improvements | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 570 | 444 |
Construction-in-progress | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | $ 2,169 | $ 4,181 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued employee compensation and benefits | $ 3,849 | $ 7,451 |
Accrued external research and development expenses | 3,686 | 2,713 |
Accrued manufacturing facility expenses | 589 | 2,349 |
Accrued general and administrative expenses | 688 | 889 |
Other | 595 | 670 |
Accrued expenses and other current liabilities | $ 9,407 | $ 14,072 |
Debt (Details)
Debt (Details) $ in Thousands | 1 Months Ended | |||||
Jun. 23, 2021 | Jun. 22, 2021 USD ($) | Dec. 21, 2018 USD ($) tranche | Jun. 30, 2020 USD ($) | Jun. 30, 2019 USD ($) | Jun. 30, 2022 USD ($) | |
Estimated future principal payments due | ||||||
2022 | $ 0 | |||||
2023 | 0 | |||||
2024 | 18,750 | |||||
2025 | 37,500 | |||||
2026 and thereafter | 18,750 | |||||
Total debt | $ 75,000 | |||||
2018 Credit facility | ||||||
Debt | ||||||
Maximum amount outstanding | $ 75,000 | |||||
Number of tranche | tranche | 3 | |||||
Debt instrument, covenant, minimum cash balance | $ 10,000 | |||||
Debt default interest rate addition (as a percent) | 4 | |||||
2018 Credit facility amendment | ||||||
Debt | ||||||
Interest rate (as a percent) | 5.50% | |||||
Prepayment fee in first year (as a percent) | 1% | |||||
Prepayment fee in second year (as a percent) | 0.50% | |||||
Prepayment fee in third year (as a percent) | 0.25% | |||||
2018 Credit facility amendment | Lenders | ||||||
Debt | ||||||
Issuance costs | $ 200 | |||||
2018 Credit facility amendment | Minimum | ||||||
Debt | ||||||
Variable interest rate (as a percent) | 2.10% | |||||
2018 Credit facility amendment | One-month U.S. LIBOR | ||||||
Debt | ||||||
Variable interest rate (as a percent) | 2.10% | 0% | ||||
Principal amount to be funded per tranche, second amendment, including additional limit | ||||||
Debt | ||||||
Principal amount | $ 35,000 | |||||
Term loan | ||||||
Debt | ||||||
Principal amount of each tranche of term loans | 25,000 | |||||
Borrowing | $ 25,000 | $ 25,000 | $ 25,000 |
Equity (Details)
Equity (Details) $ / shares in Units, $ in Millions | 6 Months Ended | |||||
Mar. 18, 2021 USD ($) shares | Jun. 30, 2022 vote $ / shares shares | Jul. 07, 2022 shares | Dec. 31, 2021 $ / shares shares | Aug. 01, 2019 USD ($) | Jul. 20, 2018 $ / shares shares | |
Equity | ||||||
Number of votes per common share | vote | 1 | |||||
Shares authorized (in shares) | 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 | |||
Subsequent event | ||||||
Equity | ||||||
Common stock, authorized (in shares) | 300,000,000 | |||||
At the market offering | ||||||
Equity | ||||||
Aggregate offering price | $ | $ 100 | |||||
Shares issued (in shares) | 0 | |||||
Offering | ||||||
Equity | ||||||
Shares issued (in shares) | 6,896,552 | |||||
Net proceeds after deducting underwriting discounts and commissions | $ | $ 187.2 |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation expense (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 5,041 | $ 9,597 | $ 13,301 | $ 18,239 |
Research and development expenses | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 2,215 | 3,056 | 5,692 | 5,587 |
General and administrative expenses | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 2,826 | $ 6,541 | 7,609 | $ 12,652 |
Stock options | ||||
Stock-based compensation expense | ||||
Unrecognized compensation cost | $ 49,200 | $ 49,200 | ||
Unrecognized compensation cost expected to be recognized over a weighted average period | 2 years 6 months | |||
Service based stock options | ||||
Stock-based compensation expense | ||||
Purchase of an aggregate shares of common stock (in shares) | 3,218,103 | |||
Options exercise price (in dollars per share) | $ 5.44 | |||
Weighted average grant-date fair value (in dollars per share) | $ 3.71 |
Commitments and Contingencies -
Commitments and Contingencies - Collaborative Arrangements and Non-collaborative Arrangement (Details) - WIBR $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement | |
Aggregate milestone payments | $ 1.6 |
License maintenance fees | Maximum | |
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 | 3 Months Ended | 6 Months Ended |
Jan. 31, 2018 | Jun. 30, 2022 | Jun. 30, 2022 | |
Commitments and Contingencies | |||
Employer matching contribution (as a percent) | 50% | ||
Company matching contribution | $ 0.2 | $ 0.6 | |
Maximum | |||
Commitments and Contingencies | |||
Percentage of employee's gross pay match (as a percent) | 6% |
Net Loss per Share - Weighted A
Net Loss per Share - Weighted Average Shares (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Numerator: | ||||||
Net loss | $ (44,241) | $ (52,412) | $ (50,180) | $ (42,330) | $ (96,653) | $ (92,510) |
Denominator: | ||||||
Weighted-average common shares outstanding, basic (in shares) | 90,257,524 | 89,517,784 | 90,203,586 | 85,936,079 | ||
Weighted-average common shares outstanding, diluted (in shares) | 90,257,524 | 89,517,784 | 90,203,586 | 85,936,079 | ||
Net loss per share, diluted (in dollars per share) | $ (0.49) | $ (0.56) | $ (1.07) | $ (1.08) | ||
Net loss per share, basic (in dollars per share) | $ (0.49) | $ (0.56) | $ (1.07) | $ (1.08) |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Diluted net loss per share attributable to common stockholders | ||
Antidilutive securities excluded from computation of of diluted weighted average shares outstanding (in shares) | 20,621,196 | 17,903,973 |
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 (in shares) | 1,413,369 | 708,668 |
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 (in shares) | 19,207,827 | 17,195,305 |