Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | Apr. 30, 2021 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2021 | |
Entity File Number | 001-38586 | |
Entity Registrant Name | RUBIUS THERAPEUTICS,Β 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 $0.001 per share | |
Trading Symbol | RUBY | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 89,316,801 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001709401 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 288,086 | $ 91,165 |
Investments | 42,564 | 85,122 |
Prepaid expenses and other current assets | 5,608 | 5,224 |
Total current assets | 336,258 | 181,511 |
Operating lease, right-of-use-asset | 39,106 | 40,447 |
Property, plant and equipment, net | 53,293 | 53,952 |
Restricted cash | 1,573 | 1,573 |
Other assets | 311 | |
Total assets | 430,230 | 277,794 |
Current liabilities: | ||
Accounts payable | 4,810 | 5,478 |
Accrued expenses and other current liabilities | 7,587 | 13,417 |
Current portion of long-term debt, net of discount | 9,375 | |
Operating lease liabilities | 8,897 | 8,945 |
Total current liabilities | 30,669 | 27,840 |
Long-term debt, net of discount and current portion | 66,262 | 74,944 |
Other long-term liabilities | 654 | 688 |
Operating lease liabilities, net of current portion | 31,662 | 32,762 |
Total liabilities | 129,247 | 136,234 |
Commitments and contingencies (see Note 9) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued or outstanding at March 31, 2021 and December 31, 2020 | ||
Common stock, $0.001 par value; 150,000,000 shares authorized at March 31, 2021 and December 31, 2020; 89,187,527 and 81,053,651 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 89 | 81 |
Additional paid-in capital | 823,688 | 621,946 |
Accumulated other comprehensive income | 7 | 4 |
Accumulated deficit | (522,801) | (480,471) |
Total stockholders' equity | 300,983 | 141,560 |
Total liabilities and stockholders' equity | $ 430,230 | $ 277,794 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
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) | 89,187,527 | 81,053,651 |
Common stock, shares outstanding (in shares) | 89,187,527 | 81,053,651 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating expenses: | ||
Research and development | $ 27,677 | $ 36,186 |
General and administrative | 13,240 | 12,664 |
Total operating expenses | 40,917 | 48,850 |
Loss from operations | (40,917) | (48,850) |
Other income (expense): | ||
Interest income | 26 | 1,049 |
Interest expense | (1,748) | (985) |
Other income, net | 309 | 300 |
Total other income (expense), net | (1,413) | 364 |
Net loss | $ (42,330) | $ (48,486) |
Net loss per share, basic and diluted | $ (0.51) | $ (0.60) |
Weighted average common shares outstanding, basic and diluted | 82,314,577 | 80,271,848 |
Comprehensive loss: | ||
Net loss | $ (42,330) | $ (48,486) |
Other comprehensive income (loss): | ||
Unrealized gains on investments, net of tax of $0 | 3 | 456 |
Comprehensive loss | $ (42,327) | $ (48,030) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||
Unrealized gains (losses) on investments, tax | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (42,330) | $ (48,486) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 8,642 | 8,488 |
Depreciation and amortization expense | 1,496 | 1,789 |
Amortization (accretion) of premium (discount) on investments | 61 | (29) |
Non-cash interest expense | 693 | 87 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (384) | 914 |
Operating lease, right-of-use-asset | 1,347 | 1,579 |
Accounts payable | (757) | 905 |
Accrued expenses and other current liabilities | (6,325) | (3,954) |
Other long-term liabilities | (34) | |
Operating lease liabilities | (1,148) | (1,308) |
Net cash used in operating activities | (38,739) | (40,015) |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment | (748) | (2,851) |
Purchases of investments | (10,001) | |
Sales and maturities of investments | 42,500 | 105,000 |
Net cash provided by investing activities | 41,752 | 92,148 |
Cash flows from financing activities: | ||
Proceeds from underwritten public offering of common stock, net of commissions and underwriting discounts | 188,000 | |
Proceeds from issuance of common stock upon exercise of stock options | 5,908 | 486 |
Net cash provided by financing activities | 193,908 | 486 |
Net increase in cash, cash equivalents and restricted cash | 196,921 | 52,619 |
Cash, cash equivalents and restricted cash at beginning of period | 92,901 | 93,633 |
Cash, cash equivalents and restricted cash at end of period | 289,822 | 146,252 |
Supplemental cash flow information: | ||
Cash paid for interest, net of interest capitalized | 1,054 | 895 |
Cash paid for leases | 1,901 | 2,147 |
Lease asset derecognized upon lease cancellation | 982 | |
Supplemental disclosure of non-cash investing and financing information: | ||
Purchases of property, plant and equipment included in accounts payable or accrued expenses | 408 | $ 923 |
Offering costs included in accounts payable and accrued expenses | $ 494 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Common stock | Additional paid-in capital | Accumulated other comprehensive income (loss) | Accumulated deficit | Total |
Stockholders Equity | $ 80 | $ 586,798 | $ 75 | $ (312,740) | $ 274,213 |
Balances at Beginning of period (in shares) at Dec. 31, 2019 | 80,016,245 | ||||
Balances at Beginning of period at Dec. 31, 2019 | $ 80 | 586,798 | 75 | (312,740) | 274,213 |
Issuance of common stock upon exercise of stock options | 486 | 486 | |||
Issuance of common stock upon exercise of stock options (in shares) | 413,721 | ||||
Stock-based compensation expense | 8,488 | 8,488 | |||
Unrealized gains on investments | 456 | 456 | |||
Stockholders Equity | $ 80 | 595,772 | 531 | (361,226) | 235,157 |
Net loss | (48,486) | (48,486) | |||
Balances at End of period (in shares) at Mar. 31, 2020 | 80,429,966 | ||||
Balances at End of period at Mar. 31, 2020 | $ 80 | 595,772 | 531 | (361,226) | 235,157 |
Balances at Beginning of period (in shares) at Dec. 31, 2019 | 80,016,245 | ||||
Balances at Beginning of period at Dec. 31, 2019 | $ 80 | 586,798 | 75 | (312,740) | 274,213 |
Stockholders Equity | $ 80 | 586,798 | 75 | (312,740) | 274,213 |
Net loss | (167,700) | ||||
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 |
Stockholders Equity | 80 | 595,772 | 531 | (361,226) | 235,157 |
Stockholders Equity | 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 | $ 1 | 5,907 | 5,908 | ||
Issuance of common stock upon exercise of stock options (in shares) | 1,237,324 | ||||
Stock-based compensation expense | 8,642 | 8,642 | |||
Unrealized gains on investments | 3 | 3 | |||
Stockholders Equity | $ 89 | 823,688 | 7 | (522,801) | 141,560 |
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 | $ 89 | 823,688 | 7 | (522,801) | 300,983 |
Stockholders Equity | $ 89 | $ 823,688 | $ 7 | $ (522,801) | $ 300,983 |
CONSOLIDATED STATEMENTS OF CONV
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | |
Estimated offering cost | $ 800 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2021 | |
Nature of the Business and Basis of Presentation | |
Nature of the Business and Basis of Presentation | RUBIUS THERAPEUTICS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 1. Nature of the Business and Basis of Presentation Rubius Therapeutics, Inc. (βRubiusβ or the βCompanyβ) 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 Companyβs 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 (βCOVID-19β), 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 Companyβs 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 Companyβs operations is uncertain and the Company will continue to assess the financial impact. On July 20, 2018, the Company completed its initial public offering (βIPOβ), 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 underwritersβ 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 Companyβs 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 (βOfferingβ), pursuant to which it issued and sold 6,896,552 shares of common stock. The aggregate net proceeds received by the Company from the Offering were $188.0 million, after deducting underwriting discounts and commissions, but before deducting offering costs payable by the Company, which are estimated to be $0.8 million. The accompanying condensed 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 $42.3 million for the three months ended March 31, 2021 and $167.7 million for the year ended December 31, 2020. As of March 31, 2021, the Company had an accumulated deficit of $522.8 million. The Company expects to continue to generate operating losses in the foreseeable future. As of May 10, 2021, the issuance date of the interim condensed consolidated financial statements, the Company expects that its cash, cash equivalents and investments will be sufficient to fund its operating expenses, capital expenditure requirements and debt service payments for at least 12 months from the issuance date of the interim condensed consolidated financial statements. The Company has financed its operations to date primarily through private placements, proceeds from its IPO and the 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 public or private 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 may need to delay, scale back or discontinue some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects. The Companyβs condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (βGAAPβ). 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. Certain prior period amounts have been reclassified to conform to the current year presentation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Unaudited Interim Financial Information The condensed consolidated balance sheet at December 31, 2020 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of March 31, 2021 and for the three months ended March 31, 2021 and 2020 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (βSECβ) 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 Companyβs audited condensed consolidated financial statements and the notes thereto for the year ended December 31, 2020 included in the Companyβs Annual Report on Form 10-K for the year-ended December 31, 2020, 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 Companyβs condensed consolidated financial position as of March 31, 2021 and condensed consolidated results of operations for the three months ended March 31, 2021 and 2020 and the condensed consolidated cash flows for the three months ended March 31, 2021 and 2020 have been made. The Companyβs condensed consolidated results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2021. 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. In the condensed consolidated financial statements, the Company uses estimates and assumptions related 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. β The full extent to which the COVID-19 pandemic will directly or indirectly impact the Companyβs 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 or treat COVID-19. β 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 Companyβs cash, cash equivalents and investments, as of March 31, 2021, consisted of money market accounts, U.S. government money market funds, U.S. government treasury bills and U.S. government treasury notes. 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 both March 31, 2021 and December 31, 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 condensed consolidated balance sheet as of March 31, 2021 and December 31, 2020. Cash, cash equivalents and restricted cash presented in the accompanying condensed consolidated statement of cash flows was $289.8 million and $146.3 million for the three months ended March 31, 2021 and 2020, respectively, of which $1.7 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: β Level 1βQuoted prices in active markets for identical assets or liabilities. β Level 2βObservable 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. β Level 3βUnobservable 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 Companyβs 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 Companyβs accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities. The carrying value of the Companyβs long-term debt approximates its fair value due to its variable interest rate, which approximates a market interest rate. Investments The Companyβs 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. 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 Companyβs investments. The Company adopted the standard effective January 1, 2020 using a prospective transition method. 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 stockholdersβ 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. β Recently Adopted Accounting Pronouncements 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). interim-period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim-period tax accounting. This guidance is effective for the Company for annual and interim periods beginning after December 31, 2020; however, early adoption is permitted. The Company adopted this standard as of January 1, 2021 on a prospective basis. The adoption did not have an impact on the Companyβs condensed consolidated financial statements. |
Investments and Fair Value of F
Investments and Fair Value of Financial Assets and Liabilities | 3 Months Ended |
Mar. 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 Investments by security type consisted of the following (in thousands): β β β β β β β β β β β β β β β β β β March 31, 2021 β β Amortized Cost β Gross β Gross β Credit Losses β Fair Value U.S. treasury bills and notes (due within one year) $ 42,557 $ 7 $ β β $ β β $ 42,564 β β $ 42,557 β $ 7 β $ β β $ β β $ 42,564 β β β β β β β β β β β β β β β β β β β December 31, 2020 β β Amortized Cost β Gross β Gross β Credit Losses β Fair Value U.S. treasury bills and notes (due within one year) $ 85,118 $ 6 $ (2) β $ β β $ 85,122 β β $ 85,118 β $ 6 β $ (2) β $ β β $ 85,122 β The following tables present the Companyβs fair value hierarchy for its assets and liabilities, which are measured at fair value on a recurring basis (in thousands): β β β β β β β β β β β β β β β β Fair value measurements at March 31, 2021 using: β β β β β β β β β β β β β β Level 1 Level 2 Level 3 Total Assets: β β β β β Cash equivalents: β β β β β Money market funds $ 275,347 $ β $ β β $ 275,347 Investments: β β β β β β β U.S. treasury bills and notes β β β 42,564 β β β 42,564 β β $ 275,347 β $ 42,564 β $ β β $ 317,911 β β β β β β β β β β β β β β β β Fair value measurements at December 31, 2020 using: β β β β β β β β β β β β β β Level 1 Level 2 Level 3 Total Assets: β β β β β Cash equivalents: β β β β β Money market funds $ 88,814 $ β $ β β $ 88,814 Investments: β β β β β β β U.S. treasury bills and notes β β β 85,122 β β β 85,122 β β $ 88,814 β $ 85,122 β $ β β $ 173,936 β 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 and U.S. government agency bonds 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 three months ended March 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 three months ended March 31, 2021. |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 3 Months Ended |
Mar. 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): β β β β β β β β β β β β β β β β β March 31, 2021 December 31, 2020 Land β $ 1,300 β $ 1,300 β Manufacturing facility β β 30,969 β β 30,969 β Manufacturing equipment β β 8,773 β β 8,782 β Laboratory equipment β 17,136 β β 16,639 Computer equipment 2,212 β 2,118 Furniture and fixtures β β 1,228 β β 1,228 β Leasehold improvements 444 β 444 Construction-in-progress 2,860 β 2,605 β 64,922 β 64,085 Less: Accumulated depreciation and amortization (11,629) β (10,133) β β $ 53,293 β $ 53,952 β β |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 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): β β β β β β β β β β β β β β β March 31, 2021 December 31, 2020 Accrued employee compensation and benefits $ 2,954 β $ 8,124 Accrued external research and development expenses 2,264 β 3,156 Accrued manufacturing facility expenses 382 β 339 Accrued general and administrative expenses β β 1,439 β β 1,244 Other 548 β 554 β β $ 7,587 β $ 13,417 β |
Debt
Debt | 3 Months Ended |
Mar. 31, 2021 | |
Debt | |
Debt | 6. Debt On December 21, 2018 (the βClosing Dateβ), the Company entered into a loan and security agreement (the βLoan Agreementβ) 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 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. Interest on the outstanding loan balance will accrue at a rate of the one-month U.S. LIBOR rate plus 5.50%. Monthly principal payments will commence 36 months after the Closing Date and will be amortized over the following 24 months. Certain backend fees are due to the lender at the time of final repayment based on the total funded term loans. The Company accrues the backend 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% in the first year, 0.50% in the second year and 0.25% in the third year. In conjunction with 2018 Credit Facility, the Company incurred issuance costs of $0.8 million. 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 March 31, 2021. 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 Companyβs assets, other than its intellectual property. As of March 31, 2021, the estimated future principal payments due were as follows (in thousands): β β β β Year ending December 31, β 2021 (nine months ending December 31) β $ β 2022 β 37,500 2023 β β 37,500 2024 β β β 2025 and thereafter β β β β β $ 75,000 β |
Equity
Equity | 3 Months Ended |
Mar. 31, 2021 | |
Equity | |
Equity | 7. Equity 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 Companyβs 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 βDistribution Agreementβ) with J.P. Morgan Securities LLC, Jefferies LLC and SVB Leerink LLC (the βSales Agentsβ), 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 Companyβs 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 βat the market offeringβ 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 March 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 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 Offering were $188.0 million, after deducting underwriting discounts and commissions, but before deducting offering costs payable by the Company, which are estimated to be $0.8 million. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. Stock-Based Compensation Service-Based Stock Options During the three months ended March 31, 2021, the Company granted options with service-based vesting conditions for the purchase of 2,459,661 shares of common stock with a weighted average exercise price of $12.53 per share and a weighted average grant-date fair value of $8.37 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): β β β β β β β β β β Three Months Ended March 31, β β 2021 2020 Research and development expenses $ 2,531 β $ 2,111 General and administrative expenses β 6,111 β 6,377 β β $ 8,642 β $ 8,488 β β As of March 31, 2021, total unrecognized compensation cost related to the unvested stock-based awards was $60.4 million, which is expected to be recognized over a weighted average period of 2.4 years. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 9. 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 (βWIBRβ), as amended, under which the Company has been granted an exclusive, sublicensable, nontransferable license under certain patent families related to the development of the Companyβs red cell therapies (the βWIBR Licenseβ). 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 monthsβ notice to WIBR. WIBR may terminate the agreement upon breach of contract or in the event of the Companyβs 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 β401(k) Planβ). 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 will make matching contributions at a rate of 50% of each employeeβs contribution up to a maximum employee contribution of 6% of eligible plan compensation. For the three months ended March 31, 2021 and 2020, the Company made matching contributions of $0.3 million and $0.3 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 | 3 Months Ended |
Mar. 31, 2021 | |
Net Loss Per Share | |
Net Loss Per Share | 10. Net Loss per Share Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts): β β β β β β β β β β Three Months Ended March 31, β β 2021 2020 Numerator: β β Net loss β $ (42,330) β $ (48,486) β β β β β Denominator: β β β Weighted average common shares outstanding, basic and diluted β 82,314,577 β 80,271,848 β Net loss per share, basic and diluted β $ (0.51) β $ (0.60) β β The Companyβs 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: β β β β β β β β β March 31, β β 2021 2020 Unvested restricted common stock 724,854 299,700 Stock options to purchase common stock 17,416,717 16,949,462 β 18,141,571 17,249,162 β β β β |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Summary of Significant Accounting Policies | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The condensed consolidated balance sheet at December 31, 2020 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of March 31, 2021 and for the three months ended March 31, 2021 and 2020 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (βSECβ) 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 Companyβs audited condensed consolidated financial statements and the notes thereto for the year ended December 31, 2020 included in the Companyβs Annual Report on Form 10-K for the year-ended December 31, 2020, 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 Companyβs condensed consolidated financial position as of March 31, 2021 and condensed consolidated results of operations for the three months ended March 31, 2021 and 2020 and the condensed consolidated cash flows for the three months ended March 31, 2021 and 2020 have been made. The Companyβs condensed consolidated results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2021. |
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. In the condensed consolidated financial statements, the Company uses estimates and assumptions related 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. β The full extent to which the COVID-19 pandemic will directly or indirectly impact the Companyβs 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 or treat COVID-19. β |
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 Companyβs cash, cash equivalents and investments, as of March 31, 2021, consisted of money market accounts, U.S. government money market funds, U.S. government treasury bills and U.S. government treasury notes. 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 | 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 March 31, 2021 and December 31, 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 condensed consolidated balance sheet as of March 31, 2021 and December 31, 2020. Cash, cash equivalents and restricted cash presented in the accompanying condensed consolidated statement of cash flows was $289.8 million and $146.3 million for the three months ended March 31, 2021 and 2020, respectively, of which $1.7 million and $1.7 million was restricted cash, respectively. |
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: β Level 1βQuoted prices in active markets for identical assets or liabilities. β Level 2βObservable 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. β Level 3βUnobservable 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 Companyβs 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 Companyβs accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities. The carrying value of the Companyβs long-term debt approximates its fair value due to its variable interest rate, which approximates a market interest rate. |
Investments | Investments The Companyβs 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. 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 Companyβs investments. The Company adopted the standard effective January 1, 2020 using a prospective transition method. 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 stockholdersβ equity. No such credit losses were recorded during the periods presented. |
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. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements 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). interim-period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim-period tax accounting. This guidance is effective for the Company for annual and interim periods beginning after December 31, 2020; however, early adoption is permitted. The Company adopted this standard as of January 1, 2021 on a prospective basis. The adoption did not have an impact on the Companyβs condensed consolidated financial statements. |
Investments and Fair Value of_2
Investments and Fair Value of Financial Assets and Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Investments and Fair Value of Financial Assets and Liabilities | |
Schedule of investments by security type | Investments by security type consisted of the following (in thousands): β β β β β β β β β β β β β β β β β β March 31, 2021 β β Amortized Cost β Gross β Gross β Credit Losses β Fair Value U.S. treasury bills and notes (due within one year) $ 42,557 $ 7 $ β β $ β β $ 42,564 β β $ 42,557 β $ 7 β $ β β $ β β $ 42,564 β β β β β β β β β β β β β β β β β β β December 31, 2020 β β Amortized Cost β Gross β Gross β Credit Losses β Fair Value U.S. treasury bills and notes (due within one year) $ 85,118 $ 6 $ (2) β $ β β $ 85,122 β β $ 85,118 β $ 6 β $ (2) β $ β β $ 85,122 |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | The following tables present the Companyβs fair value hierarchy for its assets and liabilities, which are measured at fair value on a recurring basis (in thousands): β β β β β β β β β β β β β β β β Fair value measurements at March 31, 2021 using: β β β β β β β β β β β β β β Level 1 Level 2 Level 3 Total Assets: β β β β β Cash equivalents: β β β β β Money market funds $ 275,347 $ β $ β β $ 275,347 Investments: β β β β β β β U.S. treasury bills and notes β β β 42,564 β β β 42,564 β β $ 275,347 β $ 42,564 β $ β β $ 317,911 β β β β β β β β β β β β β β β β Fair value measurements at December 31, 2020 using: β β β β β β β β β β β β β β Level 1 Level 2 Level 3 Total Assets: β β β β β Cash equivalents: β β β β β Money market funds $ 88,814 $ β $ β β $ 88,814 Investments: β β β β β β β U.S. treasury bills and notes β β β 85,122 β β β 85,122 β β $ 88,814 β $ 85,122 β $ β β $ 173,936 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 3 Months Ended |
Mar. 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): β β β β β β β β β β β β β β β β β March 31, 2021 December 31, 2020 Land β $ 1,300 β $ 1,300 β Manufacturing facility β β 30,969 β β 30,969 β Manufacturing equipment β β 8,773 β β 8,782 β Laboratory equipment β 17,136 β β 16,639 Computer equipment 2,212 β 2,118 Furniture and fixtures β β 1,228 β β 1,228 β Leasehold improvements 444 β 444 Construction-in-progress 2,860 β 2,605 β 64,922 β 64,085 Less: Accumulated depreciation and amortization (11,629) β (10,133) β β $ 53,293 β $ 53,952 β |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 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): β β β β β β β β β β β β β β β March 31, 2021 December 31, 2020 Accrued employee compensation and benefits $ 2,954 β $ 8,124 Accrued external research and development expenses 2,264 β 3,156 Accrued manufacturing facility expenses 382 β 339 Accrued general and administrative expenses β β 1,439 β β 1,244 Other 548 β 554 β β $ 7,587 β $ 13,417 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt | |
Schedule of estimated future principal payments due | As of March 31, 2021, the estimated future principal payments due were as follows (in thousands): β β β β Year ending December 31, β 2021 (nine months ending December 31) β $ β 2022 β 37,500 2023 β β 37,500 2024 β β β 2025 and thereafter β β β β β $ 75,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Stock-Based Compensation | |
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): β β β β β β β β β β Three Months Ended March 31, β β 2021 2020 Research and development expenses $ 2,531 β $ 2,111 General and administrative expenses β 6,111 β 6,377 β β $ 8,642 β $ 8,488 β |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 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 was calculated as follows (in thousands, except share and per share amounts): β β β β β β β β β β Three Months Ended March 31, β β 2021 2020 Numerator: β β Net loss β $ (42,330) β $ (48,486) β β β β β Denominator: β β β Weighted average common shares outstanding, basic and diluted β 82,314,577 β 80,271,848 β Net loss per share, basic and diluted β $ (0.51) β $ (0.60) β |
Schedule of dilutive securities excluded from computations of diluted weighted average shares outstanding | β β β β β β β β β March 31, β β 2021 2020 Unvested restricted common stock 724,854 299,700 Stock options to purchase common stock 17,416,717 16,949,462 β 18,141,571 17,249,162 |
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 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 |
Sale of Equity | |||||
Net proceeds after deducting underwriting discounts and commissions | $ 188,000 | ||||
Estimated offering cost | 800 | ||||
Net Loss | (42,330) | $ (48,486) | $ (167,700) | ||
Accumulated deficit | $ (522,801) | $ (480,471) | |||
Common stock | |||||
Sale of Equity | |||||
Shares issued (in shares) | 6,896,552 | ||||
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 | ||||
Net proceeds after deducting underwriting discounts and commissions | $ 254,300 | ||||
Offering | |||||
Sale of Equity | |||||
Shares issued (in shares) | 6,896,552 | ||||
Net proceeds after deducting underwriting discounts and commissions | $ 188,000 | ||||
Estimated offering cost | $ 800 | ||||
Overallotment | |||||
Sale of Equity | |||||
Shares issued (in shares) | 1,572,450 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Summary of Significant Accounting Policies | ||||
Restricted cash for the benefit of its leased properties | $ 1,700 | $ 1,700 | ||
Restricted cash (current) | $ 100 | $ 100 | ||
Current restricted cash included in prepaid expense and other current assets | Prepaid expenses and other current assets | Prepaid expenses and other current assets | ||
Restricted cash (non-current) | $ 1,573 | $ 1,573 | ||
Cash, cash equivalents and restricted cash | 289,822 | $ 92,901 | $ 146,252 | $ 93,633 |
Restricted cash | $ 1,700 | $ 1,700 |
Investments and Fair Value of_3
Investments and Fair Value of Financial Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Marketable securities | ||
Amortized Cost | $ 42,557 | $ 85,118 |
Gross Unrealized Gains | 7 | 6 |
Gross Unrealized Losses | (2) | |
Investments | 42,564 | 85,122 |
Assets: | ||
Investments | 42,564 | 85,122 |
Transfers between Level 1, Level 2 or Level 3 | ||
Transfers between Level 1, Level 2 and Level 3 | 0 | |
U.S. treasury bills and notes | ||
Marketable securities | ||
Amortized Cost | 42,557 | 85,118 |
Gross Unrealized Gains | 7 | 6 |
Gross Unrealized Losses | (2) | |
Investments | 42,564 | 85,122 |
Assets: | ||
Investments | 42,564 | 85,122 |
Recurring | ||
Assets: | ||
Assets | 317,911 | 173,936 |
Recurring | Money market funds | ||
Assets: | ||
Cash equivalents | 275,347 | 88,814 |
Recurring | U.S. treasury bills and notes | ||
Marketable securities | ||
Investments | 42,564 | 85,122 |
Assets: | ||
Investments | 42,564 | 85,122 |
Recurring | Level 1 | ||
Assets: | ||
Assets | 275,347 | 88,814 |
Recurring | Level 1 | Money market funds | ||
Assets: | ||
Cash equivalents | 275,347 | 88,814 |
Recurring | Level 2 | ||
Assets: | ||
Assets | 42,564 | 85,122 |
Recurring | Level 2 | U.S. treasury bills and notes | ||
Marketable securities | ||
Investments | 42,564 | 85,122 |
Assets: | ||
Investments | $ 42,564 | $ 85,122 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | $ 64,922 | $ 64,085 |
Less: Accumulated depreciation and amortization | (11,629) | (10,133) |
Property, plant and equipment, net | 53,293 | 53,952 |
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 | 30,969 | 30,969 |
Manufacturing equipment | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 8,773 | 8,782 |
Laboratory equipment | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 17,136 | 16,639 |
Computer equipment | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 2,212 | 2,118 |
Furniture and fixtures | ||
Property, Plant and Equipment, Net | ||
Property, plant and equipment, gross | 1,228 | 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 | $ 2,860 | $ 2,605 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses and Other Current Liabilities | ||
Accrued employee compensation and benefits | $ 2,954 | $ 8,124 |
Accrued external research and development expenses | 2,264 | 3,156 |
Accrued manufacturing facility expenses | 382 | 339 |
Accrued general and administrative expenses | 1,439 | 1,244 |
Other | 548 | 554 |
Accrued expenses and other current liabilities | $ 7,587 | $ 13,417 |
Debt (Details)
Debt (Details) $ in Thousands | Dec. 21, 2018USD ($)tranche | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2021USD ($) |
Estimated future principal payments due | ||||
2022 | $ 37,500 | |||
2023 | 37,500 | |||
Total debt | $ 75,000 | |||
2018 Credit Facility | ||||
Debt | ||||
Maximum amount outstanding | $ 75,000 | |||
Number of tranche | tranche | 3 | |||
Borrowing | $ 25,000 | $ 25,000 | $ 25,000 | |
Period for commencing monthly principal payments | 36 months | |||
Amortization period | 24 months | |||
Prepayment fee in first year | 1.00% | |||
Prepayment fee in second year | 0.50% | |||
Prepayment fee in third year | 0.25% | |||
Issuance costs | $ 800 | |||
Debt default interest rate addition (as a percent) | 4 | |||
2018 Credit Facility | One-month U.S. LIBOR | ||||
Debt | ||||
Variable interest rate | 5.50% | |||
Principal Amount To Be Funded Per Tranche | Term loan | ||||
Debt | ||||
Principal amount of each tranche of term loans | $ 25,000 |
Equity (Details)
Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 18, 2021 | Jul. 20, 2018 | Mar. 31, 2021 | Dec. 31, 2020 | Aug. 01, 2019 |
Equity | |||||
Common stock, authorized (in shares) | 150,000,000 | 150,000,000 | 150,000,000 | ||
Shares authorized | 160,000,000 | ||||
Common stock, par value (in dollars per share) | $ 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) | $ 0.001 | $ 0.001 | $ 0.001 | ||
Net proceeds after deducting underwriting discounts and commissions | $ 188,000 | ||||
Estimated offering cost | $ 800 | ||||
Common stock | |||||
Equity | |||||
Shares issued (in shares) | 6,896,552 | ||||
Conversion of redeemable convertible preferred stock to common stock (in shares) | 51,845,438 | ||||
IPO | |||||
Equity | |||||
Shares issued (in shares) | 12,055,450 | ||||
Net proceeds after deducting underwriting discounts and commissions | $ 254,300 | ||||
Overallotment | |||||
Equity | |||||
Shares issued (in shares) | 1,572,450 | ||||
At the market offering | |||||
Equity | |||||
Shares issued (in shares) | 0 | ||||
Percentage of commission | 3.00% | ||||
Aggregate offering price | $ 100,000 | ||||
Offering | |||||
Equity | |||||
Shares issued (in shares) | 6,896,552 | ||||
Net proceeds after deducting underwriting discounts and commissions | $ 188,000 | ||||
Estimated offering cost | $ 800 |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation expense (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Stock-based compensation expense | ||
Stock-based compensation expense | $ 8,642 | $ 8,488 |
Research and development expenses | ||
Stock-based compensation expense | ||
Stock-based compensation expense | 2,531 | 2,111 |
General and administrative expenses | ||
Stock-based compensation expense | ||
Stock-based compensation expense | 6,111 | $ 6,377 |
Stock options. | ||
Stock-based compensation expense | ||
Unrecognized compensation cost | $ 60,400 | |
Unrecognized compensation cost expected to be recognized over a weighted average period | 2 years 4 months 24 days | |
Service Based Stock Options | ||
Stock-based compensation expense | ||
Purchase of an aggregate shares of common stock | 2,459,661 | |
Options exercise price | $ 12.53 | |
Weighted average grant-date fair value (per share) | $ 8.37 |
Commitments and Contingencies -
Commitments and Contingencies - Collaborative Arrangements and Non-collaborative Arrangement (Details) - WIBR $ in Millions | 3 Months Ended |
Mar. 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 | 3 Months Ended | |
Jan. 31, 2018 | Mar. 31, 2021 | Mar. 31, 2020 | |
Commitments and Contingencies | |||
Employer matching contribution (as a percent) | 50.00% | ||
Company matching contribution | $ 0.3 | $ 0.3 | |
Maximum | |||
Commitments and Contingencies | |||
Percentage of employee's gross pay match | 6.00% |
Net Loss Per Share - Weighted A
Net Loss Per Share - Weighted Average Shares (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Numerator: | |||
Net Loss | $ (42,330) | $ (48,486) | $ (167,700) |
Denominator: | |||
Weighted average common shares outstanding, basic and diluted | 82,314,577 | 80,271,848 | |
Net loss per share, basic and diluted | $ (0.51) | $ (0.60) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Diluted net loss per share attributable to common stockholders | ||
Antidilutive securities excluded from computation of of diluted weighted average shares outstanding | 18,141,571 | 17,249,162 |
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 | 724,854 | 299,700 |
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 | 17,416,717 | 16,949,462 |