Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 15, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38295 | ||
Entity Registrant Name | X4 PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 27-3181608 | ||
Entity Address, Address Line One | 61 North Beacon Street | ||
Entity Address, Address Line Two | 4th Floor | ||
Entity Address, City or Town | Boston | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02134 | ||
City Area Code | 857 | ||
Local Phone Number | 529-8300 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | XFOR | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 29.6 | ||
Entity Common Stock, Shares Outstanding | 122,207,488 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement, (the “2023 Proxy Statement”) for its 2023 Annual Meeting of Stockholders, which the registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant's fiscal year ended December 31, 2022, are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Entity Central Index Key | 0001501697 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Name | PricewaterhouseCoopers LLP |
Auditor Location | Boston, Massachusetts, US |
Auditor Firm ID | 238 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 121,718 | $ 81,787 |
Research and development incentive receivable | 1,152 | 747 |
Prepaid expenses and other current assets | 5,807 | 5,344 |
Total current assets | 128,677 | 87,878 |
Property and equipment, net | 1,104 | 1,514 |
Goodwill | 17,351 | 17,351 |
Right-of-use assets | 7,229 | 8,710 |
Other assets | 1,225 | 1,723 |
Assets, Total | 155,586 | 117,176 |
Current liabilities: | ||
Accounts payable | 7,777 | 4,283 |
Accrued expenses | 12,034 | 7,870 |
Current portion of lease liability | 1,198 | 1,075 |
Long-term Debt, Current Maturities | 1,315 | 795 |
Liabilities, Current, Total | 22,324 | 14,023 |
Long-term debt, including accretion, net of discount | 32,304 | 33,139 |
Lease liabilities | 3,603 | 4,776 |
Warrant liability (Note 4) | 23,131 | 0 |
Other liabilities | 173 | 826 |
Total liabilities | 81,535 | 52,764 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Common Stock | 122 | 28 |
Additional paid-in capital | 450,786 | 347,374 |
Accumulated other comprehensive loss | (119) | (119) |
Accumulated deficit | (376,738) | (282,871) |
Total stockholders’ equity | 74,051 | 64,412 |
Total liabilities and stockholders’ equity | $ 155,586 | $ 117,176 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 500,000,000 | 125,000,000 |
Common stock, outstanding (in shares) | 121,667,250 | 28,127,657 |
Common stock, issued (in shares) | 121,667,250 | 28,127,657 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | |||
Revenue recognized | $ 0 | $ 0 | $ 3,000 |
Operating Expenses [Abstract] | |||
Research and development | 61,058 | 50,647 | 41,932 |
Selling, general and administrative | 27,020 | 24,702 | 20,942 |
Goodwill impairment | 0 | 9,758 | 0 |
Gain on sale of nonfinancial assets | (509) | 0 | 0 |
Total operating expenses | 87,569 | 85,107 | 62,874 |
Loss from operations | (87,569) | (85,107) | (59,874) |
Nonoperating Income (Expense) [Abstract] | |||
Interest income | 219 | 10 | 273 |
Interest expense | (3,993) | (3,642) | (2,688) |
Change in fair value of warrant and derivative liabilities | 1,701 | (366) | (437) |
Loss on extinguishment of debt | 0 | 0 | (162) |
Other income (expense) | (4,197) | 426 | 905 |
Total other expense, net | (6,270) | (3,572) | (2,109) |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | (93,839) | (88,679) | (61,983) |
Income Tax Expense (Benefit) | 28 | 17 | 148 |
Net loss and comprehensive loss | (93,867) | (88,696) | (62,131) |
Temporary Equity Repurchase Of Convertible Preferred Stock | (2,546) | (13,943) | 0 |
Net loss attributable to common stockholders | $ (96,413) | $ (102,639) | $ (62,131) |
Net loss per share attributable to common stockholders - basic (in dollars per share) | $ (1.52) | $ (3.99) | $ (3.09) |
Net loss per share attributable to common stockholders - diluted (in dollars per share) | $ (1.52) | $ (3.99) | $ (3.09) |
Weighted average shares of common stock outstanding - basic (in shares) | 63,526 | 25,749 | 20,077 |
Weighted average shares of common stock outstanding - diluted (in shares) | 63,526 | 25,749 | 20,077 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock, Redeemable Common Stock and Stockholders' Equity (Deficit) - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Redeemable Common Stock |
Beginning balance, convertible preferred stock (in share) at Dec. 31, 2019 | 0 | |||||
Beginning balance, convertible preferred stock at Dec. 31, 2019 | $ 0 | |||||
Ending balance, convertible preferred stock (in shares) at Dec. 31, 2020 | ||||||
Ending balance, convertible preferred stock at Dec. 31, 2020 | ||||||
Beginning balance (in shares) at Dec. 31, 2019 | 16,128,862 | |||||
Beginning balance at Dec. 31, 2019 | $ 129,220,000 | $ 16,000 | $ 261,367,000 | $ (119,000) | $ (132,044,000) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Exercise of stock options (in shares) | 17,689 | |||||
Exercise of stock options | 127,000 | $ 0 | 127,000 | |||
Stock-based compensation expense | $ 5,428,000 | 5,428,000 | ||||
Issuance of shares under employee stock purchase plan (in shares) | 26,643 | |||||
Issuance of shares under employee stock purchase plan | $ 169,000 | 169,000 | ||||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations (in shares) | 132,537 | |||||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations | $ (14,000) | (14,000) | ||||
Net income (loss) | (62,131,000) | (62,131,000) | ||||
Ending balance (in shares) at Dec. 31, 2020 | 16,305,731 | |||||
Ending balance at Dec. 31, 2020 | 72,799,000 | $ 16,000 | 267,077,000 | (119,000) | (194,175,000) | |
Ending balance, convertible preferred stock (in shares) at Dec. 31, 2021 | 0 | |||||
Ending balance, convertible preferred stock at Dec. 31, 2021 | $ 0 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock issued (in shares) | 9,435,951 | 229,885 | ||||
Stock issued | 73,868,000 | $ 10,000 | 73,858,000 | $ 1,875 | ||
Exercise of stock options (in shares) | 5,860 | |||||
Exercise of stock options | 40,000 | 40,000 | ||||
Stock-based compensation expense | $ 6,180,000 | 6,180,000 | ||||
Issuance of shares under employee stock purchase plan (in shares) | 45,816 | |||||
Issuance of shares under employee stock purchase plan | $ 219,000 | 219,000 | ||||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations (in shares) | 204,531 | |||||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations | $ 0 | |||||
Repurchase and retirement of redeemable common stock (in shares) | (229,885) | |||||
Repurchase and retirement of redeemable common stock | $ 0 | $ (1,875) | ||||
Net income (loss) | (88,696,000) | (88,696,000) | ||||
Exercise of warrants (in shares) | 2,129,768 | |||||
Exercise of warrants and prefunded warrants | 2,000 | $ 2,000 | ||||
Ending balance (in shares) at Dec. 31, 2021 | 28,127,657 | |||||
Ending balance at Dec. 31, 2021 | 64,412,000 | $ 28,000 | 347,374,000 | (119,000) | (282,871,000) | |
Ending balance, convertible preferred stock (in shares) at Dec. 31, 2022 | ||||||
Ending balance, convertible preferred stock at Dec. 31, 2022 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock issued (in shares) | 92,461,988 | |||||
Stock issued | 59,362,000 | $ 92,000 | 59,270,000 | |||
Stock-based compensation expense | $ 5,199,000 | 5,199,000 | ||||
Issuance of shares under employee stock purchase plan (in shares) | 204,903 | |||||
Issuance of shares under employee stock purchase plan | $ 203,000 | $ 1,000 | 202,000 | |||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations (in shares) | 372,831 | |||||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations | (13,000) | $ 0 | (13,000) | |||
Net income (loss) | (93,867,000) | (93,867,000) | ||||
Exercise of warrants (in shares) | 499,871 | |||||
Exercise of warrants and prefunded warrants | 1,000 | $ 1,000 | ||||
Reclassifications of Temporary to Permanent Equity | 38,754,000 | 38,754,000 | ||||
Ending balance (in shares) at Dec. 31, 2022 | 121,667,250 | |||||
Ending balance at Dec. 31, 2022 | $ 74,051,000 | $ 122,000 | $ 450,786,000 | $ (119,000) | $ (376,738,000) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||
Net loss | $ (93,867) | $ (88,696) | $ (62,131) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 5,199 | 6,180 | 5,428 |
Depreciation and amortization expense | 513 | 499 | 351 |
Goodwill impairment | 0 | 9,758 | 0 |
Non-cash lease expense | 1,481 | 1,393 | 879 |
Accretion of debt discount | 918 | 756 | 532 |
Loss on extinguishment of debt | 0 | 0 | 162 |
Change in fair value of warrant and derivative liability | 2,881 | 366 | 437 |
Other | 37 | 337 | (413) |
Changes in operating assets and liabilities: | |||
Prepaid expenses, other current assets and research and development incentive receivable | (610) | (1,755) | (1,655) |
Accounts payable | 3,425 | 1,166 | 1,031 |
Accrued expenses | 3,803 | (152) | 1,517 |
Operating lease liabilities | (882) | (698) | (1,067) |
Operating lease right-of-use asset, net of non-cash portion | 0 | (59) | (3,889) |
Net cash used in operating activities | (77,102) | (70,905) | (58,818) |
Cash flows from investing activities: | |||
Purchase of property, equipment and intangible assets | (103) | (615) | (1,362) |
Net cash used in investing activities | (103) | (615) | (1,362) |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options, warrants and pre-funded warrants and issuance of shares of common stock under employee stock purchase plans | 208 | 260 | 561 |
Issuance costs related to sale of warrants for the purchase of common stock accounted for as a liability and amendments to loan and security agreement (Note 10) | (4,802) | 0 | 0 |
Employee taxes paid related to net share settlement of vested restricted stock units | (12) | 0 | (278) |
Proceeds from borrowings under loan and security agreements, net of issuance costs | 0 | 0 | 12,388 |
Repayments of borrowings under loan and security agreement | (795) | 0 | 0 |
Proceeds from sale of shares of common stock, redeemable common stock, warrants and pre-funded warrants, net of issuance costs | 122,631 | 75,985 | (277) |
Payments for Repurchase of Common Stock | 0 | (2,000) | 0 |
Net cash provided by financing activities | 117,230 | 74,245 | 12,394 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (105) | (319) | 402 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 39,920 | 2,406 | (47,384) |
Cash, cash equivalents and restricted cash at beginning of period | 83,108 | 80,702 | 128,086 |
Cash, cash equivalents and restricted cash at end of period | 123,028 | 83,108 | 80,702 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 3,006 | 2,906 | 2,099 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Acquisition of property, equipment and right-of-use assets included in accounts payable | 0 | 0 | 54 |
Lease Obligation Incurred | 0 | 1,343 | 0 |
Issuance costs not yet paid | $ 661 | $ 24 | $ 0 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Nature of the Business and Basis of Presentation | NATURE OF THE BUSINESS AND BASIS OF PRESENTATION X4 Pharmaceuticals, Inc. (together with its subsidiaries, the “Company”) is a late-stage clinical biopharmaceutical company focused on the research and development of novel therapeutics for the treatment of rare diseases and those with limited treatment options, with a focus on conditions resulting from dysfunction of the immune system. The Company’s lead clinical candidate is mavorixafor, a small molecule antagonist of the chemokine receptor CXCR4 that is being developed as an oral, once-daily therapy. Due to its ability to increase the mobilization of mature, functional white blood cells from the bone marrow into the bloodstream, the Company believes that mavorixafor has the potential to provide therapeutic benefit across a variety of chronic neutropenic disorders, including WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (“WHIM”)) syndrome, a rare, primary immunodeficiency, and certain cancers. Following announcement of positive top-line data from the Company’s global, pivotal, Phase 3 clinical trial in November 2022, the Company is preparing a United States regulatory submission seeking approval of oral, once-daily mavorixafor in the treatment of people aged 12 years and older with WHIM syndrome. The Company is also currently enrolling participants in a Phase 2 clinical trial in people with certain chronic neutropenic disorders following positive results from a Phase 1b clinical trial evaluating mavorixafor in people with idiopathic, cyclic, or congenital neutropenia that were presented in the third quarter of 2022. The Company also conducted a proof-of-concept Phase 1b clinical trial of mavorixafor in combination with ibrutinib in people with Waldenström’s macroglobulinemia (“Waldenström’s”), a rare form of lymphoma. The Company reported positive results from the Waldenström’s Phase 1b trial in the third quarter of 2022 and concluded the trial in December 2022. Any further studies of mavorixafor in Waldenström’s or other oncology indication will be subject to completing a strategic partnership. The Company is headquartered in Boston, Massachusetts and has an additional facility in Vienna, Austria. Going Concern Assessment— In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) (“ASU 2014-15”), the Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. Since inception, the Company has incurred significant operating losses and negative cash flows from operations. As of December 31, 2022, the Company had $121.7 million of cash and cash equivalents, an accumulated deficit of $376.7 million, net loss of $93.9 million and net cash used in operating activities of $77.1 million. The Company has a covenant under its Second Amended and Restated Loan and Security Agreement with Hercules Capital Inc. that requires that the Company maintain a minimum level of cash of $20 million, subject to reduction to $10 million upon the achievement of operational milestones. Based on its current cash flow projections and with no additional funding, the Company believes it will not be able to maintain the minimum cash required to satisfy this covenant beginning in the first quarter of 2024. In such event, the lender could require the repayment of all outstanding debt. Management has assessed the Company’s ability to continue as a going concern in accordance with the requirements of ASC 205-40 and determined that the Company’s accumulated deficit, history of losses and future expected losses met the ASC 205-40 standard for raising substantial doubt about the Company’s ability to continue as a going concern. The Company does not have adequate financial resources to fund its forecasted operating costs for at least one year after the date that these consolidated financial statements are issued. The accompanying 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. To finance its operations, the Company will need to raise additional capital, which cannot be assured. Unless and until the Company reach’s profitability in the future, it will require additional capital to fund our operations, which could be raised through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations and strategic alliances. If the Company is unable to obtain funding, it could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which would adversely affect its business prospects, or it may be unable to continue operations. Principles of Consolidation— The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, including X4 Pharmaceuticals (Austria) GmbH (“X4 Austria”), which is incorporated in Vienna, Austria, and X4 Therapeutics, Inc. All significant intercompany accounts and transactions have been eliminated. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates— The preparation of the Company’s consolidated financial statements in conformity with U.S. Generally Accepted Accounting Principles (“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 consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the impairment or lack of impairment of long-lived assets including operating lease right-of-use assets and goodwill, and the constraint of variable consideration from contracts with customers. 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 when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. As of the date of issuance of these consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from those estimates, and any such differences may be material to the Company’s consolidated financial statements. Foreign Currency and Currency Translation— The functional currency of the Company’s foreign subsidiary, X4 Austria, is the U.S. dollar. However, X4 Austria maintains its books and records in Euro. As a result, monetary assets and liabilities are translated at current exchange rates as of the balance sheet date, non-monetary assets such as property and equipment and equity accounts are translated at historic rates and income and expenses are translated at the average exchanges rates for the period. Adjustments resulting from the translation of the consolidated financial statements of X4 Austria into U.S. dollars are included in the determination of net loss and are recorded in other expense, net. Concentrations of Credit Risk and Significant Suppliers— Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and research and development incentive receivables. The Company generally maintains cash balances in various operating accounts at financial institutions that management believes to be of high credit quality in amounts that may exceed federally insured limits. The Company has not experienced losses related to its cash and cash equivalents. The Company is dependent on third-party manufacturers to supply products for research and development activities in its programs. The Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in these manufacturing services or in the supply of active pharmaceutical ingredients and formulated drugs. Cash and Cash Equivalents— The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents consisted of money market funds as of December 31, 2022 and 2021. Restricted Cash (in thousands) As of December 31, 2022 As of December 31, 2021 Letter of credit security: Waltham lease $ 250 $ 250 Letter of credit security: Vienna Austria lease 205 216 Letter of credit security: Boston lease 855 855 Total restricted cash $ 1,310 $ 1,321 Restricted cash included in prepaid expenses and other current assets $ 285 $ — Restricted cash included in other assets $ 1,025 $ 1,321 In connection with the Company’s lease agreement for its facilities in Massachusetts and Austria, the Company maintains letters of credit, which are secured by restricted cash, for the benefit of the respective landlord. In accordance with the Company’s Second Amended and Restated Loan and Security Agreement with Hercules and as further described in Note 7, the Company at all times must maintain a minimum level of cash of $20.0 million in an account or accounts in which Hercules has a first priority security interest as further described in Note 7. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets to the sum to the total of amounts shown in the Company’s consolidated statements of cash flows as of December 31, 2022, 2021 and 2020: (in thousands) December 31, December 31, 2021 December 31, Cash and cash equivalents $ 121,718 $ 81,787 $ 78,708 Restricted cash, current (included within prepaid expenses and other current assets) 285 — 264 Restricted cash, non-current (included within other assets) 1,025 1,321 1,730 Total cash, cash equivalents and restricted cash $ 123,028 $ 83,108 $ 80,702 Property and Equipment— Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset, as follows: Estimated Useful Life Office furniture 3 to 7 years Computer equipment 3 years Laboratory equipment 3 to 10 years Leasehold improvements Shorter of lease term or 10 years Estimated useful lives are periodically assessed to determine if changes are appropriate. Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost of these assets and related accumulated depreciation or amortization are eliminated from the consolidated balance sheet and any resulting gains or losses are included in the consolidated statements of operations and comprehensive loss in the period of disposal. Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. Right-of-Use Assets and Leases— The Company accounts for leases in accordance with Accounting Standards Codification (“ASC”), Topic 842, Leases (“ASC 842”). Under ASC 842, at the inception of an arrangement, the Company determines whether the arrangement contains a lease based on the unique facts and circumstances present. Leases with a non-cancellable term greater than one year are recognized on the balance sheet as right-of-use assets with associated current and non-current lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less. Options to renew a lease are not included in the Company’s initial lease term assessment unless there is reasonable certainty that the Company will renew the lease. If a lease is cancellable without penalty, the Company excludes from the lease term periods following the cancellation notice period unless it is reasonably certain that the Company will not cancel the lease. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use operating asset may be required for items such as incentives received or accrued rent. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates it incurs to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company has referenced the effective rate of its Hercules borrowings, as adjusted for differences terms, to determine calculate its incremental borrowing rate for each of its operating leases. In accordance with the guidance in ASC 842, components of a lease are split into lease components and non-lease components. A policy election is available pursuant to which an entity may elect to not separate lease and non-lease components. Rather, each lease component and the related non-lease components are accounted for together as a single component. For new and amended leases beginning in 2019 and after, the Company has elected to account for the lease and non-lease components as a combined lease component for its office and laboratory building leases. Impairment of Long-Lived Assets— Long-lived assets consist of property and equipment and operating lease right-of-use assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. To date, the Company has not recorded any material impairment losses on long-lived assets. Goodwill— Business combinations are accounted for under the acquisition method. The total purchase price of an acquisition is allocated to the underlying identifiable net assets, based on their respective estimated fair values as of the acquisition date. Determining the fair value of assets acquired and liabilities assumed requires management’s judgment and often involves the use of significant estimates and assumptions, including assumptions with respect to future cash inflows and outflows, probabilities of success, discount rates, and asset lives, among other items. Assets acquired and liabilities assumed are recorded at their estimated fair values. The excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Goodwill is tested quantitatively for impairment at the reporting unit level annually in the fourth quarter, or more frequently when events or changes in circumstances indicate that the asset might be impaired. Examples of such events or circumstances include, but are not limited to, a significant adverse change in legal or business climate, an adverse regulatory action, a significant decline in the price of the Company’s common stock, or unanticipated competition. The Company has determined that it operates in a single operating segment and has a single reporting unit. To perform its quantitative test, the Company compares the fair value of the reporting unit to its carrying value. If the fair value of the reporting unit exceeds the carrying value of its net assets, goodwill is not impaired, and no further testing is required. If the fair value of the reporting unit is less than the carrying value, the Company measures the amount of impairment loss, if any, as the excess of the carrying value over the fair value of the reporting unit. See Note 4 for more information on the Company’s goodwill impairment tests as of December 31, 2022 and 2021. Fair Value Measurements— Certain assets and liabilities of the Company 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 that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The embedded derivative liability related to the redemption features of the Company’s debt with Hercules as described further below is carried at fair value and is a Level 3 measurement. The Company’s cash equivalents, consisting of money market funds invested in U.S. Treasury securities, are carried at fair value, determined based on Level 1 and Level 2 inputs in the fair value hierarchy described above. 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 outstanding loan and security agreement with Hercules approximates its fair value at December 31, 2022 because the debt bears interest at a variable market rate and the Company’s credit risk has not materially changed since the inception of the agreement. Segment Information— The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions. The Company’s focus is on the research, development and commercialization of novel therapeutics for the treatment of rare diseases. Revenue Recognition— The Company records revenue, if any, using the guidance of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), as amended. The Company’s revenues to date have been generated through a license agreement with Abbisko Therapeutics Co., Ltd. (“Abbisko”). For collaboration arrangements, the Company first determines which elements of the arrangement are deemed to be within the scope of ASC Topic 808 Collaborative Arrangements (“ASC 808”) and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of ASC 606. The Company’s policy is generally to recognize amounts received from collaborators in connection with joint operating activities that are within the scope of ASC 808 as a reduction in research and development expense. To date, there have been no transactions within the scope of ASC 808. Upon the potential approval of the sales and marketing of the Company’s lead product candidate, revenue related to its sale and distribution will be accounted for under ASC 606. The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company determines it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (1) identify the customer and contract(s) with a the customer; (2) identify the performance obligation(s) in the contract; (3) determine the transaction price, adjusted for variable consideration resulting from potential returns, rebates and down-stream charges; (4) allocate the transaction price to the performance obligation(s) in the contract; and (5) recognize revenue when (or as) the Company satisfies its performance obligation(s), which is expected to be upon shipment of the finished product (labelled bottles of capsulized drug product). As part of the accounting for these arrangements, the Company must make significant judgments, including the estimation of the amount of variable consideration to include in the transaction price. Once a contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: i. the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and ii. the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the customer and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using either the expected value method or the most-likely-amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price reflects the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time based on the use of an output or input method. At the inception of each arrangement that includes non-refundable payments for contingent milestones, particularly in license agreements, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most-likely-amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of the achievement of contingent milestones and the likelihood of a significant reversal of such milestone revenue, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenue in the period of adjustment. This quarterly assessment may result in the recognition of revenue related to a contingent milestone payment before the milestone event has been achieved. Research and Development Programs— Proceeds under the research and development incentive program from the Austrian government are recognized as other income in an amount equal to the qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. Incentive income recognized upon incurring qualifying expenses in advance of receipt of proceeds from research and development incentives is recorded in the consolidated balance sheet as research and development incentive receivable. Research and Development Costs— Costs associated with internal research and development and external research and development services, including drug development and preclinical studies, are expensed as incurred. Research and development expenses include costs for salaries, employee benefits, subcontractors, facility-related expenses, depreciation and amortization, stock-based compensation, third-party license fees, laboratory supplies, and external costs of outside vendors engaged to conduct discovery, preclinical and clinical development activities and clinical trials as well as to manufacture clinical trial materials, and other costs. The Company recognizes external research and development costs based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its service providers. Nonrefundable advance payments for services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such prepaid expenses are recognized as an expense when the related services have been performed, or when it is no longer expected that the goods will be delivered or the services rendered. Patent Costs— All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as selling, general and administrative expenses. Debt Issuance Costs— Debt issuance costs consist of payments made to secure commitments under certain debt financing arrangements. These amounts are recognized as interest expense over the period of the financing arrangement using the effective interest method. If the financing arrangement is canceled or forfeited, or if the utility of the arrangement to the Company is otherwise compromised, these costs are recognized as interest expense immediately. The Company’s consolidated financial statements present debt issuance costs related to a recognized debt liability as a direct reduction from the carrying amount of that debt liability. Stock-Based Compensation— The Company measures all stock-based awards granted to employees, nonemployees and directors based on the fair value on the date of the grant and recognizes compensation expense for those awards, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award. The Company issues stock-based awards with service-based vesting conditions and records the expense for these awards using the straight-line method. The Company has also issued stock-based awards with performance-based vesting conditions that vest in part upon the Company’s achievement of operational milestones and over time thereafter for the subsequent two years as the employee continues to provide services. The Company assesses the probability of achievement of these operational milestones and recognizes stock-based compensation for these awards using the accelerated attribution model based on the fair value of the awards as of the date of grant and its best estimate of the date each operational milestone will be achieved. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. The Company recognizes compensation expense for only the portion of awards that are expected to vest. In developing a forfeiture rate estimate, the Company has considered its historical experience to estimate pre-vesting forfeitures for service-based awards. The impact of a forfeiture rate adjustment is recognized in full in the period of adjustment, and if the actual forfeiture rate is materially different from the Company’s estimate, the Company may be required to record adjustments to stock-based compensation expense in future periods. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. Prior to March 13, 2019, the Company was a private company and lacked company-specific historical and implied volatility information for its common stock. Therefore, the Company estimates its expected common stock price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employee consultants is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield considers the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. Derivative Liabilities: Hercules Loan Redemption Feature— The Company’s loan agreement with Hercules (see Note 7) contains a redemption feature that, upon an event of default, provides Hercules the option to accelerate and demand repayment of the debt, including a prepayment premium, or, at its election, charge additional contingent interest fees on any overdue interest or principal payments. The redemption feature meets the definition of a derivative instrument as the repayment of the debt contains a substantial premium, resulting in the redemption feature not being clearly and closely related to its host instrument. Accordingly, the Company classifies this derivative as a liability within other liabilities (non-current) on its consolidated balance sheets. The derivative liability was initially recorded at fair value on the date of the Hercules Loan Agreement and is subsequently remeasured to fair value at each reporting date. Changes in the fair value of this derivative liability, which is included in other liabilities, are recognized as a component of other income (expense), net in the consolidated statement of operations and comprehensive loss. Changes in the fair value of this derivative liability will continue to be recognized until all amounts outstanding under the Hercules Loan Agreement are repaid or until the Hercules Loan Agreement is terminated. Comprehensive Loss— For the year ended December 31, 2022, 2021, and 2020 all foreign currency remeasurement gains and losses were included in net loss as the Company has deemed the functional currency of its foreign subsidiary to be the U.S. Dollar. Accumulated other comprehensive loss includes foreign currency translation adjustments of $119 thousand for the year ended December 31, 2019 that were included in other comprehensive loss prior to the designation of the U.S. Dollar as the functional currency of X4 Austria. Income Taxes — The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. Net Loss per Share— Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. In addition, during the years ended December 31, 2022 and 2021, in accordance with the provisions of the Company’s Class B Warrants, the exercise price of each outstanding Class B Warrant was adjusted to the price of subsequent sales of common stock. Such adjustment is presented as as a deemed dividend that adjusts net loss available to common shareholders for purposes of basic earnings per share. The deemed dividend is calculated using the Black-Scholes pricing model, taking into account historical volatility of the Company’s common stock and the estimated remaining life of the outstanding Class B Warrants. Basic shares outstanding includes the weighted average effect of the Company’s outstanding prefunded warrants, the exercise of which requires little or no consideration for |
License, Collaboration, and Fun
License, Collaboration, and Funding Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License, Collaboration, and Funding Agreements | LICENSE, COLLABORATION AND FUNDING ARRANGEMENTS Genzyme Agreement In July 2014, the Company entered into a license agreement with Genzyme (the “Genzyme Agreement”) pursuant to which the Company was granted an exclusive license to certain patents and intellectual property owned or controlled by Genzyme related to the CXCR4 receptor to develop and commercialize products containing licensed compounds (including but not limited to mavorixafor) for all therapeutic, prophylactic and diagnostic uses, with the exception of autologous and allogenic human stem cell therapy. Under the terms of the Genzyme Agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize licensed products for use in the field in the United States and at least one other major market country. The Company has the right to grant sublicenses of the licensed rights that cover mavorixafor to third parties. Under the Genzyme Agreement, the Company is obligated to pay Genzyme milestone payments in the aggregate amount of up to $25.0 million, contingent upon the achievement by the Company of certain clinical-stage regulatory and sales milestones with respect to licensed products. The Company is also obligated to pay Genzyme tiered royalties based on net sales of licensed products that the Company commercializes under the agreement. The obligation to pay royalties for each licensed product expires on a country-by-country basis on the latest of (i) the expiration of licensed patent rights that cover that licensed product in that country, (ii) the expiration of regulatory exclusivity in that country and (iii) ten years after the first commercial sale of such licensed product in that country. Royalty rates are subject to reduction under the agreement in specified circumstances, including in any country if the Company is required to obtain a license from any third party to the extent the Company’s patent rights might infringe the third party’s patent rights, if a licensed product is not covered by a valid claim in that country or if sales of generic products reach certain thresholds in that country. If the Company enters into a sublicense under the Genzyme Agreement, the Company will be obligated to pay Genzyme a percentage of certain upfront fees, maintenance fees, milestone payments and royalty payments paid to the Company by the sublicensee. Under the Genzyme Agreement, the Company will itself manufacture and supply, or enter into manufacturing or supply agreements with Genzyme or third parties to manufacture and supply, clinical and commercial supplies of licensed compounds and each licensed product. The Company is also responsible for all costs related to the filing, prosecution and maintenance of the licensed patent rights. The Genzyme Agreement will remain in effect until the expiration of the royalty term in all countries for all licensed products. The Genzyme Agreement may be terminated by either party with at least 90 days’ notice in the event of material breach by the other party that remains uncured for 90 days, by either party for insolvency or bankruptcy of the other party, immediately by Genzyme if the Company challenges the licensed patents, or immediately by the Company if a material safety issue arises. During the year ended December 31, 2020, the Company incurred $0.9 million of payment obligations to Genzyme. For the years ended December 31, 2022 and 2021, the Company did not incur any payment obligations to Genzyme under the Genzyme Agreement. Georgetown Agreement In December 2016, the Company entered into a license agreement (the “Georgetown Agreement”) with Georgetown University (“Georgetown”) pursuant to which the Company obtained an exclusive, worldwide license to make, have made, use, sell, offer for sale and import of products covered by patent rights co-owned by Georgetown. The rights licensed to the Company are for all therapeutic, prophylactic and diagnostic uses in all disease indications in humans and animals. Under the terms of the Georgetown Agreement, the Company paid a one-time, upfront fee of $50 thousand and the Company may be required to make milestone payments of up to an aggregate of $800 thousand related to commercial sales of a product. Under the Georgetown Agreement, the Company is solely responsible for all development and commercialization activities and costs in its respective territories. The Company is also responsible for all costs related to the filing, prosecution and maintenance of the licensed patent rights. The term of the Georgetown Agreement will continue until the expiration of the last valid claim within the patent rights covering the product. Georgetown may terminate the agreement in the event (i) the Company fails to pay any amount and fails to cure such failure within 30 days after receipt of notice, (ii) the Company defaults in its obligation to obtain and maintain insurance and fails to remedy such breach within 45 days after receipt of notice, or (iii) the Company declares insolvency or bankruptcy. The Company may terminate the Georgetown Agreement at any time upon at least 60 days’ written notice. During the years ended December 31, 2022, 2021 and 2020, the Company did not incur any payment obligations to Georgetown under the Georgetown Agreement and no milestone payments were made or due under the Georgetown Agreement. Beth Israel Deaconess Medical Center Agreement In December 2016, the Company entered into a license agreement (the “BIDMC Agreement”) with Beth Israel Deaconess Medical Center (“BIDMC”), pursuant to which the Company obtained an exclusive, worldwide license to make, have made, use, sell, offer for sale and import products covered by patent rights co-owned by BIDMC. The rights licensed to the Company are for all fields of use. Under the terms of the BIDMC Agreement, the Company paid a one-time, upfront fee of $20 thousand and the Company is responsible for all future patent prosecution costs. The Company recorded the upfront payment as research and development expense in the consolidated statement of operations because the acquired technology represented in-process research and development and had no alternative future use. The term of the BIDMC Agreement will continue until the expiration of the last valid claim within the patent rights covering the licensed products. BIDMC may terminate the agreement in the event (i) the Company fails to pay any amount and fails to cure such failure within 15 days after receipt of notice, (ii) the Company is in material breach of any material provision of the BIDMC Agreement and fails to remedy such breach within 60 days after receipt of notice, or (iii) the Company declares insolvency or bankruptcy. The Company may terminate the BIDMC Agreement at any time upon at least 90 days’ written notice. The Company did not incur any payment obligations under the BIDMC Agreement during the years ended December 31, 2022, 2021 and 2020. Dana Farber Cancer Institute Agreement In November 2020, the Company entered into a license agreement (the “DFCI Agreement”) with the Dana Farber Cancer Institute (“DFCI”) pursuant to which the Company obtained a non-exclusive, royalty-bearing license to use, make, have made, develop, market, import, distribute, sell and have sold products covered by patent rights owned by DFCI. Under the terms of the DFCI Agreement, the Company paid a one-time, upfront fee of $25 thousand and approximately $35 thousand for reimbursement of DFCI’s past patent expenses relating to the patent rights. The Company will pay 25% of DFCI’s ongoing patent prosecution expenses and an annual license maintenance fee of $10 thousand in each of the first three years, $40 thousand in each of the subsequent three years and $50 thousand every year after that until commercialization. The Company may be required to make milestone payments of up to an aggregate of approximately $32.3 million related to development, regulatory and commercial sales events. No such milestone payments have been incurred to date. The Company recorded the upfront payment as research and development expense in the consolidated statement of operations and comprehensive loss because the acquired technology represented in-process research and development and had no alternative future use. The term of the DCFI Agreement will continue until the expiration of the last valid claim within the patent rights covering the product. DFCI may terminate the agreement if certain events occur. Research and Development Incentive Program The Company participates in a research and development incentive program provided by the Austrian government whereby the Company is entitled to reimbursement by the Austrian government for a percentage of qualifying research and development expenses incurred by the Company’s subsidiary in Austria. Under the program, the reimbursement rate for qualifying research and development expenses incurred by the Company through X4 Austria is 14% for the current year. X4 Austria also participated in a COVID-19 incentive program, which provides reimbursement for qualified capital spending during a defined time period. The Company recognizes incentive income from Austrian research and development incentives when qualifying expenses have been incurred, there is reasonable assurance that the payment will be received, and the consideration can be reliably measured. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive program described above. At each reporting date, management estimates the reimbursable incentive income available to the Company based on available information at the time. As of the years ended December 31, 2022 and 2021, the amounts due under these programs were $1.2 million and $0.7 million, respectively, which is included in research and development incentive receivable on the consolidated balance sheets. During the years ended December 31, 2022, 2021 and 2020, the Company recorded $0.5 million, $0.8 million and $0.5 million, respectively, of income related to the program on the consolidated statement of operations and comprehensive loss within “other income”. Abbisko Agreement In July 2019, the Company entered into a license agreement with Abbisko (the “Abbisko Agreement”). Under the terms of the Abbisko Agreement, the Company granted Abbisko the exclusive right to develop, manufacture and commercialize mavorixafor in mainland China, Taiwan, Hong Kong and Macau, the (“Abbisko Territory”). The agreement provides Abbisko with the exclusive rights in the Abbisko Territory to develop and commercialize mavorixafor in combination with checkpoint inhibitors or other agents in multiple oncology indications. The Company retains the full rest-of-world rights to develop and commercialize mavorixafor outside of Greater China for all indications and the ability to utilize data generated pursuant to the Abbisko collaboration for rest-of-world development. Assuming mavorixafor is developed by Abbisko in six indications, the Company would be entitled to milestone payments of up to $214.0 million, which will vary based on the ultimate sales, if any, of the approved licensed products. In addition, upon commercialization of mavorixafor in the Abbisko Territory, the Company is eligible to receive a tiered royalty, with a percentage range in the low double-digits, on net sales of approved licensed products. Abbisko is obligated to use commercially reasonable efforts to develop and commercialize mavorixafor in the Abbisko Territory. Abbisko has responsibility for all activities and costs associated with the further development, manufacture and commercialization of mavorixafor in the Abbisko Territory. Following the closing of a qualified financing (as such term is defined in the Abbisko Agreement), Abbisko was required to pay the Company a one-time, non-refundable, non-creditable financial milestone payment of $3.0 million. Abbisko achieved such qualified financing in March 2020 and, as a result, the Company was eligible to receive the milestone payment, which was received by the Company in April 2020. The Company is also eligible to receive potential development and regulatory milestone payments, which vary based on the number of indications developed, and potential commercial milestone payments based on annual net sales of mavorixafor-based licensed products. Upon entering into the Abbisko Agreement, the Company evaluated the Abbisko Agreement under ASC 606 and determined the Abbisko Agreement contained a single performance obligation related to the exclusive license to develop and commercialize mavorixafor and the transfer of know-how that was satisfied at the inception of the arrangement. The transaction price related to the transfer of the license and know-how was fully constrained and the Company ascribed no transaction price to the development, regulatory and commercial milestones under the “most-likely amount” method. The Company concluded that any consideration related to the initial transfer of the license and know-how will be recognized when it is probable that Abbisko will achieve the related financial milestone and other operational milestones. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to Abbisko and therefore are recognized at the later of when the performance obligation is satisfied or the related sales occur. As a result of Abbisko’s achievement of the qualified financing, the Company reversed the constraint related to this milestone and recognized $3.0 million of license revenue during the year ended December 31, 2020. The Company determined that the future sale of clinical and commercial supply are optional goods that will be subject to the customer's future purchasing decisions and do not represent performance obligations in the Abbisko Agreement. The Company concluded that the amount to be charged for the clinical supply will be reflective of market value and, therefore, the Abbisko Agreement does not provide a discount on such supply that would be accounted for as material right at the outset of the contract. In arriving at these conclusions, the Company considered the complexity of the manufacturing process for the licensed compound and the potential ability for Abbisko to obtain the compound directly from other manufactures in the future. The Company expects that it will recognize revenue at a point in time when such clinical supply (and commercial supply, if applicable) is delivered to Abbisko in the future. The Company re-evaluates the transaction price, including its estimated variable consideration for milestones included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values: Fair Value Measurements as of December 31, 2022 Using: (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents—money market funds $ 70,170 $ 2,858 $ — $ 73,028 $ 70,170 $ 2,858 $ — $ 73,028 Liabilities: Embedded derivative liability $ — $ — $ 10 $ 10 Class C Warrant Liability (Note 10) 23,131 23,131 $ — $ — $ 23,141 $ 23,141 Fair Value Measurements as of December 31, 2021 Using: (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents—money market fund $ 20,000 $ 27,793 $ — $ 47,793 $ 20,000 $ 27,793 $ — $ 47,793 Liabilities: Embedded derivative liability $ — $ — $ 821 $ 821 $ — $ — $ 821 $ 821 The Company’s cash equivalents consisted of money market funds invested in U.S. Treasury securities. The money market funds were valued based on reported market pricing for the identical asset or by using inputs observable in active markets for similar securities, which represents a Level 2 measurement in the fair value hierarchy. The following table provides a roll-forward of the aggregate fair values of the Company’s warrant liability and derivative liability, for which fair values are determined using Level 3 inputs: (in thousands) Embedded Derivative Liability PIPE Warrant Liability Class C Warrant Liability Balance at December 31, 2020 $ 455 $ — $ — Change in fair value 366 0 0 Balance at December 31, 2021 821 — — Issuance of Class C Warrants 41,249 21,526 Change in fair value (811) (2,495) 1,605 Reclassification to permanent equity (38,754) Balance at December 31, 2022 $ 10 $ — $ 23,131 Valuation of Embedded Derivative Liability— The fair value of the embedded derivative liability recognized in connection with the Company’s loan agreement with Hercules (see Note 7), which is associated with additional fees due to Hercules upon events of default, was determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The fair value of this embedded derivative liability, which is reported within other non-current liabilities on the consolidated balance sheets, is estimated by the Company at each reporting date based, in part, on the results of third-party valuations, which were prepared based on a discounted cash flow model that considered the timing and probability of occurrence of a redemption upon an event of default, the potential amount of prepayment fees or contingent interest upon an event of default and the Company’s risk-adjusted discount rate of 14%. As of December 31, 2022 and December 31, 2021, the fair value of this derivative liability was $10 thousand and $821 thousand, respectively. Warrant Liabilities— On July 6, 2022, the Company issued Warrants for the purchase of its common stock in a private placement (the “ PIPE Warrants”). Upon issuance, the holder’s exercise of the PIPE Warrants was conditioned on the Company increasing it authorized shares. As there we insufficient authorized shares available at the time of issuance, the PIPE Warrants were classified as a liability and measured at fair value. On September 1, 2022, u pon shareholder approval of the increase to the Company’s authorized shares, the PIPE Warrants met all criteria required for permanent equity accounting and, accordingly, the Company remeasured the fair value of the warrant liability through “other income (expense)” and reclassified the fair value of the warrant liability to additional paid-in capital. In December 2022, the Company issued Class C Warrants for the purchase of shares of its common stock in a public offering. The Class C Warrants are accounted for as a liability on the consolidated balance sheet and are adjusted to fair value at period end through “other income (expense)” The Company calculated the fair value of the PIPE Warrants and the Class C Warrants using the Black-Scholes option pricing model with the following inputs: PIPE Warrants Class C Warrants 7/6/2022 (issuance) 9/1/2022 (reclassification to permanent equity) 12/9/2022 (issuance) December 31, 2022 Common stock price $1.09 $1.04 $0.93 $0.99 Risk-free interest rate 2.96 % 3.29 % 3.75 % 4.00 % Expected term (in years) 5.00 4.86 5.00 4.92 Expected volatility 97.30 % 97.50 % 101.80 % 101.70 % Expected dividend yield — % — % — % — % Impairment of Goodwill Goodwill is tested quantitatively for impairment at the reporting unit level annually in the fourth quarter, or more frequently when events or changes in circumstances indicate that the asset might be impaired. During the fourth quarter of 2021, the Company’s market capitalization, measured as the price of the Company’s common stock multiplied by common shares outstanding, was below the value of the Company’s net assets, including goodwill. As a result of the sustained decline in the market price of the Company’s common stock, the fair value of the Company’s single reporting unit, determined based on Company’s market capitalization on December 31, 2021, was lower than its carrying value and the Company concluded that goodwill was impaired. Accordingly, the Company recorded an impairment charge of $9.8 million to reduce the carrying amount of goodwill to $17.4 million as of December 31, 2021. The Company tested goodwill for impairment as of December 31, 2022 and concluded that goodwill was not further impaired. Should the market value of the Company’s common stock decline, additional impairment charges may be recorded in the future. The following table provides a rollforward of the Company’s goodwill and accumulated impairment losses. (in thousands) Goodwill, Gross Accumulated Impairment Loss Goodwill Goodwill at December 31, 2020 $ 27,109 $ — $ 27,109 Impairment losses — (9,758) (9,758) Goodwill at December 31, 2021 27,109 (9,758) 17,351 Goodwill at December 31, 2022 $ 27,109 $ (9,758) $ 17,351 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | PROPERTY AND EQUIPMENT Property and equipment, net consisted of the following: (in thousands) December 31, December 31, Leasehold improvements $ 228 $ 228 Furniture and fixtures 1,268 1,251 Computer equipment 173 150 Software 24 33 Lab equipment 639 576 2,332 2,238 Less: Accumulated depreciation and amortization (1,228) (724) $ 1,104 $ 1,514 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Other Income and Expenses [Abstract] | |
Accrued Expenses | ACCRUED EXPENSES Accrued expenses consisted of the following: (in thousands) December 31, December 31, Accrued employee compensation and benefits $ 6,592 $ 5,417 Accrued external research and development expenses 3,906 1,507 Accrued professional fees 571 632 Accrued deferred financing fees 591 25 Other 374 289 $ 12,034 $ 7,870 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | LONG-TERM DEBT Long-term debt consisted of the following: (in thousands) December 31, December 31, Principal amount of long-term debt $ 32,500 $ 32,500 Debt (discount) premium, net of accretion (196) 277 Cumulative accrual of end of term payments 1,315 1,157 Long-term debt 33,619 33,934 Less: current portion of long-term debt (1,315) (795) Long-term debt, net of current portion $ 32,304 $ 33,139 Hercules Loan Agreement, As Amended-— In October 2018, the Company entered into a Loan and Security Agreement (the “Hercules Loan Agreement”), as subsequently amended from time to time with Hercules, under which the Company has borrowed an aggregate of $32.5 million of term loans to date. The Hercules Loan Agreement provided for maximum borrowings of up to $50.0 million, which included, subject to Hercules investment committee’s sole discretion, a right of the Company to request that Hercules make additional term loan advances in an aggregate amount of up to $17.5 million through December 31, 2022. Borrowings under the Hercules Loan Agreement accrued interest at a variable rate equal to the greater of (i) 8.75%, or (ii) The Wall Street Journal prime rate plus 3.75%. In an event of default, and until such event is no longer continuing, the interest rate applicable to borrowings would be increased by 4.0%. The Company concluded that each of the amendments completed during the year ended December 31, 2022 represented a modification to the debt as opposed to an extinguishment. Accordingly, fees paid to third parties directly related to the amended debt were expensed as incurred and fees paid to Hercules in conjunction with the amendment were deferred and are being amortized to interest expense over the life of the debt arrangement using the effective interest method. Pursuant to the Hercules Loan Agreement, effective as of September 1, 2022, the Company was required to maintain cash in an account or accounts in which Hercules has a first priority security interest, in an aggregate amount greater than $30.0 million. Following the Company’s achievement of an operational performance milestone, as defined in the Hercules Loan Agreement, the required level was reduced to $20.0 million; and provided further, that subject to the Company’s filing of a NDA for mavorixafor for the treatment of WHIM syndrome, this covenant would be extinguished. As of December 31, 2022, borrowings under the Hercules Loan Agreement were repayable in monthly interest-only payments through July 1, 2023, and in equal monthly payments of principal and accrued interest from August 1, 2023 until the maturity date of the loan, which was July 1, 2024. The Company recognized interest expense under the Hercules Loan Agreement as follows: (in thousands) For the years ended 2022 2021 2020 Total interest expense $ 3,989 $ 3,642 $ 2,686 Non-cash interest expense $ 918 $ 756 $ 531 The annual effective interest rate on the Hercules Loan Agreement as of December 31, 2022 was 13.5%. There were no principal payments due or paid under the Hercules Loan Agreement during the year ended December 31, 2022. An end-of-term payment of $0.8 million was paid during the year ended December 31, 2022 in accordance with the Hercules Loan Agreement. As of December 31, 2022, future principal payments and accrued end-of-term payments due under the Hercules Loan Agreement were as follows (in thousands): Year Ending December 31 Total 2023 $ 14,037 2024 19,779 Long-term debt, including end-of-term payments $ 33,816 As of December 31, 2022, the Company had the intent and ability to refinance the short-term principal obligations of the Hercules Loan Agreement to long-term, as demonstrated by entering into the Second Amended and Restated Loan and Security Agreement on January 6, 2023 as noted below. Therefore, short-term debt on the December 31, 2022 consolidated balance sheet includes only the accrued portion of certain end-of-term payments due within one year of the consolidated balance sheet date that remained due within one year of the consolidated balance sheet date following the January 6, 2023 refinancing. Second Amended and Restated Loan and Security Agreement-— On January 6, 2023, the Company entered into a Second Amended and Restated Loan and Security Agreement (the “Second A&R Loan Agreement”), which amended and restated all previous loan and security agreements with Hercules. The Second A&R Loan Agreement provides for maximum borrowings of up to $32.5 million. Borrowings under the Second A&R Loan Agreement accrue interest at a variable rate equal to the greater of (i) 10.15%, or (ii) The Wall Street Journal prime rate plus 3.15%. In an event of default, and until such event is no longer continuing, the interest rate applicable to borrowings would be increased by 4.0%. Borrowings under the Second A&R Loan Agreement are repayable in monthly interest-only payments through September 2024, and in equal monthly payments of principal and accrued interest from October 1, 2024 until the maturity date of the loan on April 1, 2026; provided however, if certain conditions are met and the Company achieves certain operational and financial milestones, the maturity date will be extended to July 1, 2027. Under the Second A&R Loan Agreement, the Company may prepay all, but not less than all, of the outstanding borrowings, subject to a prepayment premium of up to 3.0% of the principal amount outstanding as of the date of repayment. Under the Second A&R Loan Agreement, the Company has agreed to affirmative and negative covenants. Pursuant to the Second A&R Loan Agreement, the Company is required to maintain cash in an account or accounts in which Hercules has a first priority security interest, in an aggregate amount greater than $20.0 million. Upon the FDA approval of the sale and marketing of mavorixafor for the treatment to patients with WHIM syndrome with a label claim that is generally consistent with that sought in the Company’s NDA filing, the required level shall be reduced to $10.0 million. A breach of any of the covenants under the Second A&R Loan Agreement could result in a default under the loan. Upon the occurrence of an event of default under the loan facility with Hercules, the lender could elect to declare all amounts outstanding, if any, to be immediately due and payable and terminate all commitments to extend further credit. If there are any amounts outstanding that the Company is unable to repay, the lenders could proceed against the collateral granted to them to secure such indebtedness. Borrowings under the Second A&R Loan Agreement are collateralized by substantially all of the Company’s personal property and other assets except for its intellectual property (but including rights to payment an proceeds from the sale, licensing or disposition of the intellectual property). The Second A&R Loan Agreement restricts the Company’s ability to incur additional indebtedness, pay dividends, encumber its intellectual property, or engage in certain fundamental business transactions, such as mergers or acquisitions of other businesses, with certain exceptions. Under the Hercules Loan Agreement, the Company was required to pay “end-of-term” payments of $1.3 million and $0.8 million payable on July 1, 2023 and July 1, 2024, respectively. In connection with entering into the Second A&R Loan Agreement on January 6, 2023, the end-of-term payment of $1.3 million was paid and the due date of the $0.8 million end-of-term payment was accelerated to July 1, 2023. The Second A&R Loan Agreement added an additional end-of-term payment of $1.3 million that is due on April 1, 2026. These end-of-term payments are accelerated upon the prepayment of the borrowings upon the Company’s election on upon default of the loan. As of January 6, 2023, future principal payments due under the Second A&R Loan Agreement are as follows (in thousands): Year Ending December 31 Total 2023 $ — 2024 5,070 2025 21,646 2026 5,784 Long-term debt $ 32,500 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | LEASES The Company has lease agreements for its facilities in Boston, Massachusetts, which is the Company’s principal executive offices; Vienna, Austria, which is the Company’s research and development center; and Waltham, Massachusetts, which the Company has sublet to a third party. The Company previously had a lease agreement for a facility in Cambridge, Massachusetts, which served as its prior corporate headquarters. There are no restrictions or financial covenants associated with any of the lease agreements. Boston Lease — The Company leases approximately 28,000 square feet of office space in Boston, Massachusetts (“Boston Lease”), which serves as the Company’s headquarters. Base rental payments are approximately $1.0 million annually, plus certain operating expenses. The term of the Boston Lease will continue until November 2026, unless earlier terminated. The Company has the right to sublease the premises, subject to landlord consent and also has the right to renew the Boston Lease for an additional five years at the then prevailing effective market rental rate. The Company is required to maintain a security deposit in the form of a letter of credit for $0.9 million for the benefit of the landlord. Waltham Lease— The Company leases approximately 6,000 square feet of office space in Waltham, Massachusetts (“Waltham Lease”). The Waltham Lease, as amended, commenced on January 1, 2019, and expires approximately five years from the commencement date. The base rent is approximately $0.3 million annually. In addition to the base rent, the Company is also responsible for its share of operating expenses, electricity and real estate taxes, which costs are not included in the determination of the leases’ right-of-use assets or lease liabilities. The Company is subleasing the space to a third party for the duration of the lease. The right-of-use asset is being amortized to rent expense over the five Vienna Austria Leases— The Company has an operating lease for approximately 1,200 square meters of laboratory and office space in Vienna, Austria (“Vienna Lease”), which commenced in February 2021 for a term of seven years. The annual base rent for the Vienna Lease is approximately $300 thousand. As the Company’s leases do not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The components of lease expense for the three years ended December 31, 2022, 2021 and 2020 were as follows (dollars in thousands): For the Year Ended December 31, Lease Cost 2022 2021 2020 Fixed operating lease cost $ 2,080 $ 2,087 $ 1,290 Short-term lease costs — 42 157 Total lease expense $ 2,080 $ 2,129 $ 1,447 Other information Operating cash flows from operating leases $ 1,354 $ 1,257 $ 3,820 Leased assets obtained in exchange for new operating lease liabilities $ — $ 1,343 $ 5,090 Weighted-average remaining lease term—operating leases 4.0 years 5.0 years 5.5 years Weighted-average discount rate—operating leases 11.4 % 11.3 % 11.2 % Sublease income $ 196 $ 196 $ 194 Maturities of lease liabilities due under lease agreements that have commenced as of December 31, 2022 are as follows (in thousands): Maturity of lease liabilities Operating Leases 2023 $ 1,608 2024 1,374 2025 1,402 2026 1,332 2027 and thereafter 325 Total lease payments 6,041 Less: interest (1,240) Total operating lease liabilities as of December 31, 2022 $ 4,801 |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES The Company has agreements with clinical research organizations (“CROs”) pursuant to which the Company and the CROs are conducting clinical trials of mavorixafor for the treatment of WHIM syndrome, Waldenström’s and chronic neutropenia disorders. The Company may terminate these agreements by providing notice pursuant to the contractual provisions of such agreements and would incur early termination fees. The Company also has agreements with contract manufacturing organizations (“CMOs”) for the production of mavorixafor for use in clinical trials. The Company’s agreement with the CMO who produces batches of API for use in the Company’s clinical drug supply contains cancellation provisions that would require the Company to pay up to the full contract value upon cancellation. As of December 31, 2022, the Company has approximately $1.5 million of such commitments in place subject to cancellation provisions. License Agreements— See Note 3 for a summary of the Company’s license agreements, which commit the Company to contingent milestone and royalty fees based on future operational events. Indemnification Agreements— In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, 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 its executive officers that will require the Company to, among other things, 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. To date, the Company has not incurred any material costs as a result of such indemnification obligations. The Company is not currently aware of any indemnification claims and has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2022 or December 31, 2021. Legal Proceedings— The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities. 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. |
Preferred and Common Stock Warr
Preferred and Common Stock Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Preferred and Common Stock Warrants | COMMON STOCK WARRANTS Class A Warrants In connection with its issuance of common stock in public offerings that closed on April 16, 2019, the Company issued 3,900,000 Class A warrants, which are exercisable for shares of the Company's common stock or prefunded warrants to purchase shares of the Company's common stock. The Class A warrants have an exercise price of $13.20 per warrant, expire on April 15, 2024 and were immediately exercisable upon issuance. Class B Warrants In connection with its issuance of common stock in public offerings that closed on November 29, 2019, the Company issued 5,416,667 Class B warrants, which are exercisable for shares of the Company's common stock or prefunded warrants to purchase shares of the Company's common stock. The Class B warrants were immediately exercisable upon issuance, had an initial exercise price of $15.00 per share, which in accordance with the Class B warrant agreement was subsequently reduced to the price at which the Company sold its common shares in public offering or private placements. The Class B warrants expired in accordance with the Class B warrant agreement on December 29, 2022, which was 30 calendar days from the date on which the Company issued a press release announcing top-line data from its Phase 3 clinical trial of mavorixafor for the treatment of patients with WHIM syndrome. Q2 PIPE Warrants In connection withe its issuance of common stock and prefunded warrants in a private placement that closed on July 6, 2022, the Company issued warrants to purchase an aggregate of 50,925,365 warrants (the “Warrants”) for the purchase of shares of common stock. Each Warrant has an exercise price equal to $1.095 per share and will expire on the date that is 60 months from their original issue date. Class C Warrants In connection with its issuance of common stock in public offerings that closed on December 9, 2022, the Company issued 65,525,894 Class C warrants, which are exercisable at two Class C warrants for one share of the Company's common stock or prefunded warrants to purchase shares of the Company's common stock. The Class C warrants have an exercise price of $1.50 per set of two Class C warrants, expire on December 9, 2027 and were immediately exercisable upon issuance. Pre-funded Warrants In connection with the sale of its common stock in public offerings and private placements, the Company has issued pre-funded warrants to purchase shares of its common stock. The price per pre-funded warrant represents the price per share sold in the public offering or private placement, minus a nominal exercise price of either $0.001 or $0.01 per share, in accordance with the applicable pre-funded warrant agreement. The pre-funded warrants are exercisable, subject to certain beneficial ownership restrictions, at any time after their original issuance and will not expire. The following table provides a roll forward of outstanding warrants and pre-funded warrants for the purchase of shares of the Company’s common stock for the three years ended December 31, 2022: Number of warrants Weighted Average Exercise Price Weighted Average Contractual Term (Years) Outstanding and exercisable as of December 31, 2020 13,354,403 $ 13.52 3.72 Issued 2,058,032 Exercised (2,130,000) Expired (25.275) Outstanding and exercisable as of December 31, 2021 13,257,160 $ 7.96 2.72 Issued 104,531,257 Exercised (500,100) Expired (5,416,567) Outstanding and exercisable as of December 31, 2022 111,871,750 $ 1.86 4.53 As of December 31, 2022, the Company’s outstanding warrants and pre-funded warrants to purchase shares of common stock consisted of the following: Issuance Date Number of Shares of Common Stock Issuable Exercise Price Expiration Date October 25, 2016 5,155 $ 19.78 October 24, 2026 December 28, 2017 115,916 $ 19.78 December 28, 2027 September 12, 2018 20,220 $ 19.78 September 12, 2028 October 19, 2018 20,016 $ 19.78 October 19, 2028 March 13, 2019 5,000 $ 19.78 March 12, 2029 April 16, 2019 3,866,154 $ 13.20 April 15, 2024 November 29, 2019 1,250,000 $ 12.00 (a) n/a March 23, 2021 50,000 $ 8.70 (b) n/a November 9, 2021 2,008,032 $ 4.98 (c) n/a March 3, 2022 766,666 $ 1.80 (d) n/a July 6, 2022 13,276,279 $ 1.095 (e) n/a July 6, 2022 50,925,365 $ 1.095 July 6, 2027 December 9, 2022 32,762,947 $ 1.50 December 9, 2027 December 9, 2022 6,800,000 $ 1.10 (f) n/a 111,871,750 (a) In November 2019, the Company received $11.999 per pre-funded warrant, or $21.0 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.001 per pre-funded warrant; (b) In March 2021, the Company received $8.69 per pre-funded warrant, or $435 thousand in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.01 per pre-funded warrant; (c) In November 2021, the Company received $4.97 per pre-funded warrant, or $10.0 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.01 per pre-funded warrant; (d) In March 2022, the Company received $1.79 per pre-funded warrant, or $1.40 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.01 per pre-funded warrant; ( e) In July 2022, the Company received $1.094 per pre-funded warrant, or $14.5 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.001 per pre-funded warrant; and (f) In December 2022, the Company received $1.099 per pre-funded warrant, or $7.5 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.001 per pre-funded warrant. |
Common Stock, Redeemable Common
Common Stock, Redeemable Common Stock and Convertible Preferred Stock (converted to Common Stock) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
COMMON STOCK, REDEEMABLE COMMON STOCK AND PREFERRED STOCK | COMMON STOCK AND REDEEMABLE COMMON STOCK Common Stock— As of December 31, 2022, the Company’s Certificate of Incorporation, as amended and restated, authorizes the Company to issue 500 million shares of $0.001 par value common stock. The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of the holders of the preferred stock. 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 entitled to receive dividends, as may be declared by the board of directors, if any. No cash dividends have been declared or paid to date. ATM Sales Agreement On August 7, 2020, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “ATM Sales Agreement”) with B. Riley Securities, Inc., Cantor Fitzgerald & Co., and Stifel, Nicolaus & Company, Incorporated (collectively the “Sales Agents”), pursuant to which the Company may offer and sell, at the Company’s sole discretion through one or more of the Sales Agents, shares of its common stock having an aggregate offering price of up to $50.0 million. To date, the Company has sold approximately $14.3 million, net of offering costs, of common stock under the ATM Sales Agreement. Q1 2021 Private Placement On March 18, 2021, the Company entered into a securities purchase agreement with several institutional and accredited investors pursuant to which the Company agreed to issue and sell in a private placement (the “Private Placement”) an aggregate of 6,271,836 shares of common stock, 229,885 shares of redeemable common stock and, to certain investors, in lieu of common stock, pre-funded warrants to purchase an aggregate of 50,000 shares of common stock at a price of $8.70 per share of common stock (or $8.69 per pre-funded warrant). The Private Placement closed on March 23, 2021 and the Company received gross proceeds of $55.0 million, before deducting offering expenses payable by the Company. In August 2021, the investor who purchased the redeemable common stock exercised its option to sell its 229,885 shares of redeemable common stock back to the Company at the original purchase price of $8.70 per share for an aggregate of $2.0 million. The Company adjusted the carrying amount of the redeemable common stock to its redemption value and subsequently retired these shares. Lincoln Park Capital Fund Purchase Agreement On January 14, 2022, the Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a securities purchase agreement (the “LPC Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company has the right to sell shares of common stock to Lincoln Park, having an aggregate value of up to $50.0 million, subject to certain limitations and conditions set forth in the LPC Purchase Agreement, at the Company’s request from time to time during the 36-month term of the LPC Purchase Agreement. In consideration for entering into the LPC Purchase Agreement, the Company issued 230,414 shares of common stock to Lincoln Park as an initial commitment fee. Upon execution of the LPC Purchase Agreement and the Registration Rights Agreement on January 14, 2022, the Company sold to Lincoln Park, as an initial purchase under the LPC Purchase Agreement, a total of 1,382,488 shares of common stock, at a per share price of $2.17 per share, for aggregate consideration of approximately $3.0 million. Q1 2022 PIPE On March 3, 2022, the Company entered into a securities purchase agreement pursuant to which it agreed to issue and sell to an investor, in a private placement (the “Q1 2022 PIPE”), 900,000 shares of common stock at a price of $1.80 per share, which represents the volume weighted average price per share of the Company’s common stock as quoted on the Nasdaq Stock Market for the thirty (30) consecutive-day trading day period ending on March 2, 2022, and pre-funded warrants to purchase 766,666 shares of common stock at a purchase price of $1.79 per pre-funded warrant (representing the price of $1.80 per share minus the $0.01 per share exercise price of each such prefunded warrant). The pre-funded warrants are exercisable at any time after their original issuance date and will have no expiration date. The Q1 2022 PIPE closed on March 7, 2022 and the Company received gross proceeds of $3.0 million, before deducting offering expenses payable by the Company. In accordance with an associated registration rights agreement, the Company filed a registration statement covering the resale of these securities in April 2022. Q2 2022 PIPE On June 30, 2022, the Company entered into a securities purchase agreement with several institutional and accredited investors pursuant to which the Company agreed to issue in a private placement (the “Q2 2022 PIPE”) an aggregate of 37,649,086 shares of common stock and, to certain investors, in lieu of common stock, pre-funded warrants to purchase an aggregate of 13,276,279 shares of common stock at a price of $1.095 per share of common stock (or $1.094 per pre-funded warrant) and 50,925,365 warrants (the “Warrants”) for the purchase of shares of common stock. Each Warrant has an exercise price equal to $1.095 per share and will expire on the date that is 60 months from their original issue date. The price per pre-funded warrant represents the price of $1.095 per share sold in the Q2 2022 PIPE, minus the $0.001 per share exercise price of each such pre-funded warrant. The pre-funded warrants are exercisable, subject to certain beneficial ownership restrictions, at any time after their original issuance and will not expire. The Q2 2022 PIPE closed on July 6, 2022 and the Company received gross proceeds of $55.7 million, before deducting offering expenses paid by the Company. The exercise of any Warrant was conditioned upon the Company increasing its authorized shares. Accordingly, the Company convened a special meeting of its stockholders on September 1, 2022, during which the stockholders approved an increase in the number of authorized shares of common stock from 125 million to 500 million pursuant to an amendment to the Company’s Certificate of Incorporation. As of July 6, 2022, due to the shortfall in authorized and available common shares, the Warrants did not meet the criteria required for permanent equity accounting. As a result, the Company allocated $41.2 million of the gross proceeds from the offering to the fair value of the Warrants, which was recorded as a warrant liability, and the remaining $13.5 million was allocated to the common shares and pre-funded warrants and recorded as permanent equity. The fair value of the warrant liability was calculated using the Black-Scholes option valuation model. The Company also allocated a portion of the transaction fees, including commissions and legal fees, to the warrant liability and expensed within other expense, net, approximately $2.9 million of these fees upon the closing of the Q2 2022 PIPE. Upon shareholder approval of the increase to the Company’s authorized shares, the Warrants met all criteria required for permanent equity accounting and, accordingly, the Company remeasured the fair value of the warrant liability through earnings, which resulted in approximately $2.5 million of income included within other income (expense) and reclassified the fair value of the warrant liability to additional paid-in capital. Also on June 30, 2022, the Company entered into a registration rights agreement, pursuant to which the Company agreed to register for resale the common shares issued in the Q2 2022 PIPE and the issuance of the shares of common stock underlying the Pre-Funded Warrants and the Warrants sold in the offering. Such registration statement was filed on July 29, 2022 and was declared effective by the SEC on August 5, 2022. Q4 2022 Public Offering On December 7, 2022, the Company sold 52,300,000 shares of common stock and, in lieu of common stock, prefunded warrants to purchase 6,800,000 shares of common stock, and accompanying Class C warrants to purchase 32,762,947 shares of its common stock. The common stock was issued at a price to the public of $1.10 per share and the accompanying Class C warrants and prefunded warrants were issued at a price of $1.099 per prefunded warrant and accompanying Class C warrant. The Class C warrants have an exercise price of $1.50, will expire 5 years from the date of issuance, and are immediately exercisable with certain restrictions. The gross proceeds from the offering, which closed on December 9, 2022, were $65.1 million before deducting underwriting discounts and offering expenses. The Company has concluded that the Class C warrants do not meet the equity contract scope exception under ASC 815-40 as in the event of a fundamental transaction such as a merger certain provisions may require the Company to adjust the settlement value that is not consistent with a fixed-for-fixed option pricing model. As a result, as of issuance date, the Company allocated $21.5 million of the gross proceeds from the offering to the Class C Warrants based on their fair value, which was recorded as a warrant liability, and the remaining $43.6 million was allocated to the common shares and pre-funded warrants and recorded as permanent equity. The warrant liability was subsequently adjusted to fair value at December 31, 2022 and will be adjusted to fair value at each subsequent balance sheet date until the warrants are settled. Changes in fair value of the warrants are recognized as a component of other income (expense), net in the consolidated statement of operations and comprehensive loss. The fair value of the warrant liability was calculated using the Black-Scholes option valuation model as further described in Note 4. The Company also allocated a portion of the transaction fees, including commissions and legal fees, to the Class C Warrant liability and expensed within other expense, net, approximately $1.7 million of these fees upon the closing of the Q4 2022 Public Offering. For each of the common stock offerings, the Company evaluated the common stock, warrants and prefunded warrants for liability or equity classification in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity , and ASC 815-40, Derivatives and Hedging , and, other than as described above for warrants issued in the Q2 2022 PIPE and the Q4 2022 Public Offering, determined that equity treatment was appropriate as the warrants and prefunded warrants did not meet the definition of a liability. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION Summary of Plans— The Company issues stock awards under the following plans: (a) The 2015 Employee, Director and Consultant Equity Incentive Plan, as amended (the “2015 Plan”), (b) the Amended and Restated 2017 Equity Incentive Plan (the “2017 Plan”), (c) the 2017 Employee Stock Purchase Plan (the “2017 ESPP”) and the 2019 Inducement Equity Incentive Plan (the “2019 Plan”). These plans are administered by the Board of Directors or by a committee thereof. The exercise prices, vesting and other restrictions are determined at the discretion of the Board of Directors, or its committee if so delegated, except that the exercise price per share of stock options may not be less than 100% of the fair market value of the share of common stock on the date of grant and the term of the stock option may not be greater than ten years. Incentive stock options granted to employees and restricted stock awards granted to employees, officers, members of the Board of Directors, advisors, and consultants of the Company typically vest over four years. Non-statutory options granted to employees, officers, members of the Board of Directors, advisors, and consultants of the Company typically vest over three 2015 Employee, Director and Consultant Equity Incentive Plan— Under the 2015 Plan, the Company grants incentive stock options, nonqualified stock options, restricted stock awards and other stock-based awards to employees, directors and consultants of the Company. As of December 31, 2022, there were approximately 19 thousand shares available for issuance under the 2015 Plan. 2017 Equity Incentive Plan— Under the 2017 Plan, the Company may grant incentive stock options, non-qualified options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. Under an “evergreen” provision of the 2017 Plan, shares of common stock reserved for issuance under the 2017 Plan are increased annually on the first day of each year, beginning on January 1, 2021 and ending on January 1, 2027, in an amount equal to the lower of 4.0% of the number of shares of the Company’s common stock outstanding on January 1 of each year or an amount determined by the Company’s Board of Directors. As of December 31, 2022, approximately 298 thousand shares were available for future issuance under the 2017 Plan. As of January 1, 2023, an additional 4.8 million shares became available for future issuance under the 2017 Plan under the evergreen provision. 2017 Employee Stock Purchase Plan— The 2017 ESPP provides participating employees with the opportunity to purchase shares of the Company’s common stock at defined purchase prices over six-month offering periods. For the twelve months ended December 31, 2022, 204,903 shares of common stock were issued under the 2017 ESPP. As of December 31, 2022, approximately 64 thousand shares were available for future issuance under the 2017 ESPP. Pursuant to the evergreen provision of the 2017 ESPP, on January 1, 2023, an additional 85 thousand shares became available for future issuance under the 2017 ESPP. 2019 Inducement Equity Incentive Plan— On June 17, 2019, the Board of Directors approved the adoption of the 2019 Plan, as amended, which is used exclusively for the grant of equity awards to individuals who were not previously employees of the Company ( or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4). The total number of shares of common stock that may be issued under the 2019 Plan, as amended, is 2.3 million shares. Shares that are expired, forfeited, canceled or otherwise terminated without having been fully exercised will be available for future grant under the 2019 Plan. In addition, shares of common stock that are tendered to the Company by a participant to exercise an award are added to the number of shares of common stock available for future grants. As of December 31, 2022, approximately 1.3 million shares were available for future issuance under the 2019 Plan. Stock Option Valuation— The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant-date fair value of stock options granted: Year Ended 2022 2021 2020 Risk-free interest rate 3.4 % 1.0 % 0.6 % Expected term (in years) 6.06 5.96 6.01 Expected volatility 96.0 % 97.3 % 94.9 % Expected dividend yield 0 % 0 % 0 % Stock Options The following table summarizes the Company’s stock option activity for the twelve months ended December 31, 2022: Number of Shares Weighted Weighted Average Contractual Term (in Years) Aggregate Intrinsic Value (in Thousands) Outstanding as of December 31, 2021 1,916,051 $ 10.01 7.8 $ — Granted 759,200 1.76 Forfeited (653,771) 9.75 Outstanding as of December 31, 2022 2,021,480 $ 6.99 6.5 $ 1 Exercisable as of December 31, 2022 1,114,604 $ 9.93 6.3 $ — Vested and expected to vest as of December 31, 2022 1,722,110 $ 7.77 7.3 $ — The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock to the extent the stock option had a lower exercise price. The aggregate intrinsic value of stock options exercised during the twelve months ended December 31, 2021 and 2020 was $13 thousand and $42 thousand, respectively. There were no stock options exercised for the twelve months ended December 31, 2022. The weighted average grant-date fair value per share of stock options granted during the years ended December 31, 2022, 2021 and 2020 was $1.38, $5.17, and $6.12, respectively. Restricted Stock Units — During the twelve months ended December 31, 2022, the Company granted 1.8 million restricted stock units to employees at a weighted average grant date fair value of $2.09 per share. These restricted stock units are time-based and vest annually as the employee provides services to the Company. The Company recognizes stock-based compensation expense ratably, net of estimated forfeitures, over the estimated vesting period. The following table summarizes the Company’s restricted stock activity for the twelve months ended December 31, 2022: Number of Shares Unvested at December 31, 2021 925,101 Granted 1,814,425 Vested (384,814) Forfeited (674,149) Unvested at December 31, 2022 1,680,563 Stock-Based Compensation— As of December 31, 2022, total unrecognized compensation expense related to unvested stock options and restricted stock units was $4.4 million, which is expected to be recognized over a weighted average period of 1.5 years. Stock-based compensation expense was classified in the consolidated statements of operations as follows: Year Ended 2022 2021 2020 Research and development expense $ 2,534 $ 2,723 $ 2,316 Selling, general and administrative expense 2,665 3,457 3,112 Total stock-based compensation $ 5,199 $ 6,180 $ 5,428 Stock Appreciation Rights— On November 7, 2022 (the “Grant Date”), the compensation committee of the Board of Directors approved special retention and recognition grants of stock appreciation rights pursuant to the 2017 Plan to the Company’s President and Chief Executive Officer, the Company’s Chief Financial Officer and Treasurer, and certain other executive officers of the Company. The SARs have a measurement price per SAR equal to $1.80, the closing price per share of the Company’s common stock on the Grant Date, and each grant of SARs will have a maximum term of ten years from the Grant Date. Unless otherwise determined by the Board of Directors, the SARs will be settled in cash upon exercise. The settlement value will be based on the difference between the closing price of the Company’s common stock on the date of settlement less $1.80 multiplied by the number of SARs exercised. The SARs will vest and become exercisable in equal annual installments on the first, second, and third anniversaries of the Grant Date, subject to the recipient remaining an employee of the Company through and including each applicable vesting date. The calculation of the fair value of the outstanding SARs includes the closing price of the Company’s common stock of $0.99 and the following assumptions on a weighted average basis: December 31, Risk-free interest rate 3.95 % Expected term (in years) 5.86 Expected volatility 96.96 % Expected dividend yield — % Expected Forfeiture Rate 22 % |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXESDuring the years ended December 31, 2022, 2021, and 2020, the Company recorded no income tax benefits for the net operating losses incurred and research and development credits generated due to the uncertainty of realizing a benefit from those items. Additionally during the years ended December 31, 2022, 2021 and 2020, the Company recorded immaterial a tax provisions related to its Austrian subsidiary. Also during the year ended December 31, 2020, the Company recorded a U.S. tax provision related to local withholdings associated with a milestone payment received from a customer in a foreign jurisdiction. Loss before the provision for income taxes for the years ended December 31, 2022, 2021 and 2020 consisted of the following: Year Ended December 31, (in thousands) 2022 2021 2020 United States $ (94,742) $ (89,865) $ (62,539) Foreign (Austria) 903 1,186 556 $ (93,839) $ (88,679) $ (61,983) A reconciliation of the U.S. federal statutory income tax rate to the Company's effective income tax rate is as follows: Year Ended December 31, 2022 2021 2020 U.S. federal statutory income tax rate (21.0) % (21.0) % (21.0) % State income taxes, net of federal benefit (5.5) (5.4) (5.9) Research and development tax credits (1.0) (0.9) (1.1) Other permanent differences 3.0 3.7 0.9 Change in deferred tax asset valuation allowance 23.2 23.7 27.2 Other 1.3 (0.1) 0.1 Effective income tax rate — % — % 0.2 % Net deferred tax assets as of December 31, 2022 and 2021 consisted of the following: December 31, (in thousands) 2022 2021 Net operating loss carryforwards $ 107,296 $ 101,863 Research and development tax credit carryforwards 6,694 5,444 Capitalized research and development expenses 16,004 1,760 Lease liabilities 1,016 1,243 Other 3,604 3,372 Total deferred tax assets 134,614 113,682 Valuation allowance (133,112) (111,835) Deferred tax assets, net of valuation allowance $ 1,502 $ 1,847 Right of use assets 1,502 1,847 Total deferred tax liabilities $ 1,502 $ 1,847 Total deferred tax assets, net $ — $ — As of December 31, 2022, the Company had U.S. federal and state net operating loss carryforwards of $342.9 million and $336.5 million, respectively, which may be available to offset future taxable income and begin to expire in 2031 and 2035, respectively. The Company has federal net operating losses $288.8 million, which do not expire, and $54.1 million of federal net operating losses generated prior to 2018 th at will expire at various dates thro ugh 2037. In addition, as of December 31, 2022, the Company had foreign net operating loss carryforward of $61.2 million, which do not expire but are generally limited in their usage to an annual deduction equal to 75% of taxable income. As of December 31, 2022, the Company also had U.S. federal and state research and development tax credit carryforwards of $5.2 million and $1.9 million, respectively, which may be available to offset future tax liabilities and each beg in to expire in 2032 and 2030, re spectively. The Tax Cuts and Jobs Act (the “Act”) was enacted on December 22, 2017. Under the Act, research and experimental expenditures incurred for tax years beginning after December 31, 2021 must be capitalized and amortized ratably over five or fifteen years for tax purposes, depending on where the research activities are conducted, in accordance with Section 174 of the Internal Review Code (“Section 174 Expenditures”). For the year ended December 31, 2022, the Company capitalized $59.0 million and received $5.3 million of amortization deductions related to such Section 174 Expenditures, which on a tax-effected basis represent $14.7 million of the deferred tax assets shown in “Capitalized research and development costs” in the table above. The Company has elected to treat global intangible low-taxed income (“GILTI”) as a period cost, so the capitalization of research and experimental costs in GILTI increases the Company’s provision for income taxes. If the requirement to capitalize Section 174 expenditures is not modified, it may also impact our effective tax rate and our cash tax liability in future years. As of December 31, 2022, uncertain tax position reserves recorded were $0.2 million for U.S. federal and state research and development tax credits. The following table summarizes the Company’s reserve for uncertain tax positions for the three years ended December 31, 2022: (in millions) Reserve for Uncertain Tax Position Balance as of December 31, 2020 $ 0.3 Settlement of unrecognized tax benefit (0.1) Balance as of December 31, 2021 0.2 Balance as of December 31, 2022 $ 0.2 Utilization of the U.S. net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the U.S. net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. Each period, the Company evaluates the positive and negative evidence bearing upon its ability to realize its federal, state and foreign deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of its deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2022, 2021 and 2020. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2022, 2021 and 2020 related primarily to the increases in net operating loss carryforwards and research and development tax credit carryforwards and were as follows: Year Ended December 31, (in thousands) 2022 2021 2020 Valuation allowance, beginning of year $ (111,835) $ (92,197) $ (73,410) Increases recorded to income tax provision (21,277) (19,638) (18,787) Valuation allowance, end of year $ (133,112) $ (111,835) $ (92,197) |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE Basic and diluted net loss per share attributable to common stockholders was calculated as follow: Year Ended (in thousands, except per share data) 2022 2021 2020 Numerator: Net loss $ (93,867) $ (88,696) $ (62,131) Deemed dividend as a result of Class B Warrant price reset (2,546) (13,943) — Net loss attributable to common stockholders $ (96,413) $ (102,639) $ (62,131) Denominator: Weighted average shares of common stock—basic and diluted 63,526 25,749 20,077 Net loss per share attributable to common stockholders— basic and diluted $ (1.52) $ (3.99) $ (3.09) Basic and diluted weighted average shares of common stock outstanding for the three years ended December 31, 2022 includes the weighted average effect of 24,150,977 pre-funded warrants, for the purchase of shares of common stock, for which the remaining unfunded exercise price is less than or equal to $0.01 per share. During the years ended December 31, 2022 and 2021, in accordance with the Class B Warrant agreement, the exercise price of each outstanding Class B Warrant was adjusted to the price of subsequent sales of common stock. Such adjustments are accounted for as a deemed dividend that adjusts net loss available to common shareholders for purposes of basic earnings per share. The deemed dividend is calculated using the Black-Scholes pricing model, taking into account historical volatility of the Company’s common stock and the estimated remaining life of the outstanding Class B Warrants. The Company’s potentially dilutive securities included outstanding stock options, unvested restricted stock units and warrants to purchase shares of common stock for the three years ended December 31, 2022. These potentially 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, and thus they are considered “anti-dilutive.” 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 shares of common stock from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Year Ended 2022 2021 2020 Options to purchase common stock 2,021,480 1,916,051 1,874,514 Unvested restricted stock units 1,680,563 925,101 572,460 Warrants to purchase common stock (excluding prefunded warrants, which are included in basic shares outstanding) 87,720,773 9,449,128 9,474,403 91,422,816 12,290,280 11,921,377 |
Loss on Transfer of Nonfinancia
Loss on Transfer of Nonfinancial Assets | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Loss on Transfer of Nonfinancial Assets | ON SALE OF NONFINANCIAL ASSETS During the year ended December 31, 2022, a third party, who had previously acquired rights to certain intellectual property from the Company, terminated the arrangement and transferred these rights back to the Company. Also during the year ended December 31, 2022, the Company transferred these rights to another third party in return for $0.5 million. The Company has no continuing involvement in any ongoing research and development activities associated with the intellectual property. The Company concluded that these third parties are "non-customers" as the underlying intellectual property transferred to and from these third parties supports potential drug candidates that are not aligned with the Company's strategic focus and, therefore, are not an output of the Company's ordinary activities. Accordingly, the Company accounted for the sale of the intellectual property as the sale of a non-financial asset under ASC Topic 610-20, Gains and Losses from the Derecognition of Nonfinancial Assets ("ASC 610-20"), and included the gain in gain on sale of non-financial asset for the year ended December 31, 2022. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS Second Amendment and Restatement of Hercules Loan Agreement As further disclosed in Note 7, on January 6, 2023, the Company entered the Second A&R Loan Agreement with Hercules, which provides for a term loan of $32.5 million. The Second A&R Loan Agreement amended and restated the previous loan and security agreement, as amended. The Second A&R Loan Agreement does not require any scheduled amortization payments prior to October 1, 2024; provided however, if certain conditions are met, then amortization payments will not be required until January 1, 2026. The entire principal balance and all accrued but unpaid interest shall be due on the maturity date, which is April 1, 2026; provided however, if certain conditions are met, the maturity date will be extended to July 1, 2027. Borrowings bear interest at a per annum rate equal to the greater of (i) 3.15% plus The Wall Street Journal prime rate or (ii) 10.15%. Interest payments are due on a monthly basis. In an event of default and until such event is no longer continuing, the interest rate applicable to borrowings under the Second A&R Loan Agreement would be increased by 4.00%. Please see Note 7 for further disclosures related to the Second A&R Loan Agreement with Hercules. Borrowings under the Second A&R Loan Agreement are collateralized by substantially all of the Company’s personal property and other assets except for their intellectual property (but including rights to payment and proceeds from the sale, licensing or disposition of the intellectual property). Under the Second A&R Loan Agreement, the Borrowers have agreed to affirmative and negative covenants to which the Company will remain subject until maturity or repayment in full. Such covenants include maintaining a minimum liquidity amount of cash and cash equivalents in an aggregate amount greater than or equal to $20.0 million or, on and after certain conditions have been met, cash and cash equivalents in an aggregate amount greater than or equal to $10.0 million. The Company’s obligations under the Second A&R Loan Agreement are subject to acceleration upon occurrence of specified events of default, including payment default, insolvency and a material adverse change in the Company’s business, operations or financial or other condition. In addition, under the Second A&R Loan Agreement, Hercules has the right to participate, in a cumulative amount of up to $1.0 million in the aggregate, and subject to exceptions as provided in the Second A&R Loan Agreement, in any future offering of the Company’s equity securities for cash that is solely for financing purposes and is broadly marketed to multiple investors. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates— The preparation of the Company’s consolidated financial statements in conformity with U.S. Generally Accepted Accounting Principles (“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 consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the impairment or lack of impairment of long-lived assets including operating lease right-of-use assets and goodwill, and the constraint of variable consideration from contracts with customers. 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 when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. As of the date of issuance of these consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from those estimates, and any such differences may be material to the Company’s consolidated financial statements. |
Foreign Currency and Currency Translation | Foreign Currency and Currency Translation— The functional currency of the Company’s foreign subsidiary, X4 Austria, is the U.S. dollar. However, X4 Austria maintains its books and records in Euro. As a result, monetary assets and liabilities are translated at current exchange rates as of the balance sheet date, non-monetary assets such as property and equipment and equity accounts are translated at historic rates and income and expenses are translated at the average exchanges rates for the period. Adjustments resulting from the translation of the consolidated financial statements of X4 Austria into U.S. dollars are included in the determination of net loss and are recorded in other expense, net. |
Concentrations of Credit Risk and Significant Suppliers | Concentrations of Credit Risk and Significant Suppliers— Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and research and development incentive receivables. The Company generally maintains cash balances in various operating accounts at financial institutions that management believes to be of high credit quality in amounts that may exceed federally insured limits. The Company has not experienced losses related to its cash and cash equivalents. The Company is dependent on third-party manufacturers to supply products for research and development activities in its programs. The Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in these manufacturing services or in the supply of active pharmaceutical ingredients and formulated drugs. |
Cash and Cash Equivalents | Cash and Cash Equivalents— The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents consisted of money market funds as of December 31, 2022 and 2021. |
Property and Equipment | Property and Equipment— Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset, as follows: Estimated Useful Life Office furniture 3 to 7 years Computer equipment 3 years Laboratory equipment 3 to 10 years Leasehold improvements Shorter of lease term or 10 years Estimated useful lives are periodically assessed to determine if changes are appropriate. Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost of these assets and related accumulated depreciation or amortization are eliminated from the consolidated balance sheet and any resulting gains or losses are included in the consolidated statements of operations and comprehensive loss in the period of disposal. Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. |
Right-of-Use Assets and Leases | Right-of-Use Assets and Leases— The Company accounts for leases in accordance with Accounting Standards Codification (“ASC”), Topic 842, Leases (“ASC 842”). Under ASC 842, at the inception of an arrangement, the Company determines whether the arrangement contains a lease based on the unique facts and circumstances present. Leases with a non-cancellable term greater than one year are recognized on the balance sheet as right-of-use assets with associated current and non-current lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less. Options to renew a lease are not included in the Company’s initial lease term assessment unless there is reasonable certainty that the Company will renew the lease. If a lease is cancellable without penalty, the Company excludes from the lease term periods following the cancellation notice period unless it is reasonably certain that the Company will not cancel the lease. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use operating asset may be required for items such as incentives received or accrued rent. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates it incurs to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company has referenced the effective rate of its Hercules borrowings, as adjusted for differences terms, to determine calculate its incremental borrowing rate for each of its operating leases. In accordance with the guidance in ASC 842, components of a lease are split into lease components and non-lease components. A policy election is available pursuant to which an entity may elect to not separate lease and non-lease components. Rather, each lease component and the related non-lease components are accounted for together as a single component. For new and amended leases beginning in 2019 and after, the Company has elected to account for the lease and non-lease components as a combined |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets— Long-lived assets consist of property and equipment and operating lease right-of-use assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. To date, the Company has not recorded any material impairment losses on long-lived assets. |
Goodwill | Goodwill— Business combinations are accounted for under the acquisition method. The total purchase price of an acquisition is allocated to the underlying identifiable net assets, based on their respective estimated fair values as of the acquisition date. Determining the fair value of assets acquired and liabilities assumed requires management’s judgment and often involves the use of significant estimates and assumptions, including assumptions with respect to future cash inflows and outflows, probabilities of success, discount rates, and asset lives, among other items. Assets acquired and liabilities assumed are recorded at their estimated fair values. The excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Goodwill is tested quantitatively for impairment at the reporting unit level annually in the fourth quarter, or more frequently when events or changes in circumstances indicate that the asset might be impaired. Examples of such events or circumstances include, but are not limited to, a significant adverse change in legal or business climate, an adverse regulatory action, a significant decline in the price of the Company’s common stock, or unanticipated competition. |
Fair Value Measurement | Fair Value Measurements— Certain assets and liabilities of the Company 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 that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
Segment Information | Segment Information— The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions. The Company’s focus is on the research, development and commercialization of novel therapeutics for the treatment of rare diseases. |
Revenue Recognition | Revenue Recognition— The Company records revenue, if any, using the guidance of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), as amended. The Company’s revenues to date have been generated through a license agreement with Abbisko Therapeutics Co., Ltd. (“Abbisko”). For collaboration arrangements, the Company first determines which elements of the arrangement are deemed to be within the scope of ASC Topic 808 Collaborative Arrangements (“ASC 808”) and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of ASC 606. The Company’s policy is generally to recognize amounts received from collaborators in connection with joint operating activities that are within the scope of ASC 808 as a reduction in research and development expense. To date, there have been no transactions within the scope of ASC 808. Upon the potential approval of the sales and marketing of the Company’s lead product candidate, revenue related to its sale and distribution will be accounted for under ASC 606. The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company determines it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (1) identify the customer and contract(s) with a the customer; (2) identify the performance obligation(s) in the contract; (3) determine the transaction price, adjusted for variable consideration resulting from potential returns, rebates and down-stream charges; (4) allocate the transaction price to the performance obligation(s) in the contract; and (5) recognize revenue when (or as) the Company satisfies its performance obligation(s), which is expected to be upon shipment of the finished product (labelled bottles of capsulized drug product). As part of the accounting for these arrangements, the Company must make significant judgments, including the estimation of the amount of variable consideration to include in the transaction price. Once a contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: i. the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and ii. the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the customer and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using either the expected value method or the most-likely-amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price reflects the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time based on the use of an output or input method. At the inception of each arrangement that includes non-refundable payments for contingent milestones, particularly in license agreements, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most-likely-amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of the achievement of contingent milestones and the likelihood of a significant reversal of such milestone revenue, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenue in the period of adjustment. This quarterly assessment may result in the recognition of revenue related to a contingent milestone payment before the milestone event has been achieved. |
Research and Development Programs | Research and Development Programs— Proceeds under the research and development incentive program from the Austrian government are recognized as other income in an amount equal to the qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. Incentive income recognized upon incurring qualifying expenses in advance of receipt of proceeds from research and development incentives is recorded in the consolidated balance sheet as research and development incentive receivable. |
Research and Development Cost | Research and Development Costs— Costs associated with internal research and development and external research and development services, including drug development and preclinical studies, are expensed as incurred. Research and development expenses include costs for salaries, employee benefits, subcontractors, facility-related expenses, depreciation and amortization, stock-based compensation, third-party license fees, laboratory supplies, and external costs of outside vendors engaged to conduct discovery, preclinical and clinical development activities and clinical trials as well as to manufacture clinical trial materials, and other costs. The Company recognizes external research and development costs based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its service providers. |
Patent Cost | Patent Costs— All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as selling, general and administrative expenses. |
Debt Issuance Costs | Debt Issuance Costs— Debt issuance costs consist of payments made to secure commitments under certain debt financing arrangements. These amounts are recognized as interest expense over the period of the financing arrangement using the effective interest method. If the financing arrangement is canceled or forfeited, or if the utility of the arrangement to the Company is otherwise compromised, these costs are recognized as interest expense immediately. The Company’s consolidated financial statements present debt issuance costs related to a recognized debt liability as a direct reduction from the carrying amount of that debt liability. |
Stock-Based Compensation | Stock-Based Compensation— The Company measures all stock-based awards granted to employees, nonemployees and directors based on the fair value on the date of the grant and recognizes compensation expense for those awards, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award. The Company issues stock-based awards with service-based vesting conditions and records the expense for these awards using the straight-line method. The Company has also issued stock-based awards with performance-based vesting conditions that vest in part upon the Company’s achievement of operational milestones and over time thereafter for the subsequent two years as the employee continues to provide services. The Company assesses the probability of achievement of these operational milestones and recognizes stock-based compensation for these awards using the accelerated attribution model based on the fair value of the awards as of the date of grant and its best estimate of the date each operational milestone will be achieved. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. The Company recognizes compensation expense for only the portion of awards that are expected to vest. In developing a forfeiture rate estimate, the Company has considered its historical experience to estimate pre-vesting forfeitures for service-based awards. The impact of a forfeiture rate adjustment is recognized in full in the period of adjustment, and if the actual forfeiture rate is materially different from the Company’s estimate, the Company may be required to record adjustments to stock-based compensation expense in future periods. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. Prior to March 13, 2019, the Company was a private company and lacked company-specific historical and implied volatility information for its common stock. Therefore, the Company estimates its expected common stock price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employee consultants is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield considers the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. |
Derivative Liabilities | Derivative Liabilities: Hercules Loan Redemption Feature— The Company’s loan agreement with Hercules (see Note 7) contains a redemption feature that, upon an event of default, provides Hercules the option to accelerate and demand repayment of the debt, including a prepayment premium, or, at its election, charge additional contingent interest fees on any overdue interest or principal payments. The redemption feature meets the definition of a derivative instrument as the repayment of the debt contains a substantial premium, resulting in the redemption feature not being clearly and closely related to its host instrument. Accordingly, the Company classifies this derivative as a liability within other liabilities (non-current) on its consolidated balance sheets. The derivative liability was initially recorded at fair value on the date of the Hercules Loan Agreement and is subsequently remeasured to fair value at each reporting date. Changes in the fair value of this derivative liability, which is included in other liabilities, are recognized as a component of other income (expense), net in the consolidated statement of operations and comprehensive loss. Changes in the fair value of this derivative liability will continue to be recognized until all amounts outstanding under the Hercules Loan Agreement are repaid or until the Hercules Loan Agreement is terminated. |
Comprehensive Loss | Comprehensive Loss— For the year ended December 31, 2022, 2021, and 2020 all foreign currency remeasurement gains and losses were included in net loss as the Company has deemed the functional currency of its foreign subsidiary to be the U.S. Dollar. Accumulated other comprehensive loss includes foreign currency translation adjustments of |
Income Taxes | Income Taxes — The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. |
Net Loss per Share | Net Loss per Share— Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. In addition, during the years ended December 31, 2022 and 2021, in accordance with the provisions of the Company’s Class B Warrants, the exercise price of each outstanding Class B Warrant was adjusted to the price of subsequent sales of common stock. Such adjustment is presented as as a deemed dividend that adjusts net loss available to common shareholders for purposes of basic earnings per share. The deemed dividend is calculated using the Black-Scholes pricing model, taking into account historical volatility of the Company’s common stock and the estimated remaining life of the outstanding Class B Warrants. Basic shares outstanding includes the weighted average effect of the Company’s outstanding prefunded warrants, the exercise of which requires little or no consideration for the delivery of shares of common stock. Diluted net loss attributable to common stockholders is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the diluted net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period, including potential dilutive shares of common stock. For purpose of this calculation, outstanding stock options, convertible preferred stock and warrants to purchase shares of convertible preferred stock or common stock are considered potential dilutive shares of common stock. Recently Adopted Accounting Standards On January 1, 2022, the Company adopted ASU 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options |
Recently Adopted and Issued Accounting Pronouncements | In June 2016, the FASB issued ASU 2016-13, Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), as amended. ASU 2016-13 requires that financial assets measured at amortized cost, such as trade receivables, be presented net of expected credit losses, which may be estimated based on relevant information such as historical experience, current conditions, and future expectation for each pool of similar financial asset. The new guidance requires enhanced disclosures related to trade receivables and associated credit losses. In accordance with ASU 2019-10, Financial Instruments-Credit Losses (Topic 326), Derivative and Hedging (Topic 815), and Leases (Topic 842)- Effective Dates, as the Company meets |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Restricted Cash | Restricted Cash (in thousands) As of December 31, 2022 As of December 31, 2021 Letter of credit security: Waltham lease $ 250 $ 250 Letter of credit security: Vienna Austria lease 205 216 Letter of credit security: Boston lease 855 855 Total restricted cash $ 1,310 $ 1,321 Restricted cash included in prepaid expenses and other current assets $ 285 $ — Restricted cash included in other assets $ 1,025 $ 1,321 |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash to Cash Flows | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets to the sum to the total of amounts shown in the Company’s consolidated statements of cash flows as of December 31, 2022, 2021 and 2020: (in thousands) December 31, December 31, 2021 December 31, Cash and cash equivalents $ 121,718 $ 81,787 $ 78,708 Restricted cash, current (included within prepaid expenses and other current assets) 285 — 264 Restricted cash, non-current (included within other assets) 1,025 1,321 1,730 Total cash, cash equivalents and restricted cash $ 123,028 $ 83,108 $ 80,702 |
Property and Equipment Useful Life | Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset, as follows: Estimated Useful Life Office furniture 3 to 7 years Computer equipment 3 years Laboratory equipment 3 to 10 years Leasehold improvements Shorter of lease term or 10 years |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Assets Measured on Recurring Basis | The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values: Fair Value Measurements as of December 31, 2022 Using: (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents—money market funds $ 70,170 $ 2,858 $ — $ 73,028 $ 70,170 $ 2,858 $ — $ 73,028 Liabilities: Embedded derivative liability $ — $ — $ 10 $ 10 Class C Warrant Liability (Note 10) 23,131 23,131 $ — $ — $ 23,141 $ 23,141 Fair Value Measurements as of December 31, 2021 Using: (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents—money market fund $ 20,000 $ 27,793 $ — $ 47,793 $ 20,000 $ 27,793 $ — $ 47,793 Liabilities: Embedded derivative liability $ — $ — $ 821 $ 821 $ — $ — $ 821 $ 821 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The following table provides a roll-forward of the aggregate fair values of the Company’s warrant liability and derivative liability, for which fair values are determined using Level 3 inputs: (in thousands) Embedded Derivative Liability PIPE Warrant Liability Class C Warrant Liability Balance at December 31, 2020 $ 455 $ — $ — Change in fair value 366 0 0 Balance at December 31, 2021 821 — — Issuance of Class C Warrants 41,249 21,526 Change in fair value (811) (2,495) 1,605 Reclassification to permanent equity (38,754) Balance at December 31, 2022 $ 10 $ — $ 23,131 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions | The Company calculated the fair value of the PIPE Warrants and the Class C Warrants using the Black-Scholes option pricing model with the following inputs: PIPE Warrants Class C Warrants 7/6/2022 (issuance) 9/1/2022 (reclassification to permanent equity) 12/9/2022 (issuance) December 31, 2022 Common stock price $1.09 $1.04 $0.93 $0.99 Risk-free interest rate 2.96 % 3.29 % 3.75 % 4.00 % Expected term (in years) 5.00 4.86 5.00 4.92 Expected volatility 97.30 % 97.50 % 101.80 % 101.70 % Expected dividend yield — % — % — % — % |
Schedule of Goodwill | The following table provides a rollforward of the Company’s goodwill and accumulated impairment losses. (in thousands) Goodwill, Gross Accumulated Impairment Loss Goodwill Goodwill at December 31, 2020 $ 27,109 $ — $ 27,109 Impairment losses — (9,758) (9,758) Goodwill at December 31, 2021 27,109 (9,758) 17,351 Goodwill at December 31, 2022 $ 27,109 $ (9,758) $ 17,351 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property and equipment, net consisted of the following: (in thousands) December 31, December 31, Leasehold improvements $ 228 $ 228 Furniture and fixtures 1,268 1,251 Computer equipment 173 150 Software 24 33 Lab equipment 639 576 2,332 2,238 Less: Accumulated depreciation and amortization (1,228) (724) $ 1,104 $ 1,514 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Income and Expenses [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: (in thousands) December 31, December 31, Accrued employee compensation and benefits $ 6,592 $ 5,417 Accrued external research and development expenses 3,906 1,507 Accrued professional fees 571 632 Accrued deferred financing fees 591 25 Other 374 289 $ 12,034 $ 7,870 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Long-term debt consisted of the following: (in thousands) December 31, December 31, Principal amount of long-term debt $ 32,500 $ 32,500 Debt (discount) premium, net of accretion (196) 277 Cumulative accrual of end of term payments 1,315 1,157 Long-term debt 33,619 33,934 Less: current portion of long-term debt (1,315) (795) Long-term debt, net of current portion $ 32,304 $ 33,139 |
Interest Income and Interest Expense Disclosure | The Company recognized interest expense under the Hercules Loan Agreement as follows: (in thousands) For the years ended 2022 2021 2020 Total interest expense $ 3,989 $ 3,642 $ 2,686 Non-cash interest expense $ 918 $ 756 $ 531 |
Schedule of Maturities of Long-term Debt | As of December 31, 2022, future principal payments and accrued end-of-term payments due under the Hercules Loan Agreement were as follows (in thousands): Year Ending December 31 Total 2023 $ 14,037 2024 19,779 Long-term debt, including end-of-term payments $ 33,816 As of December 31, 2022, the Company had the intent and ability to refinance the short-term principal obligations of the Hercules Loan Agreement to long-term, as demonstrated by entering into the Second Amended and Restated Loan and Security Agreement on January 6, 2023 as noted below. Therefore, short-term debt on the December 31, 2022 consolidated balance sheet includes only the accrued portion of certain end-of-term payments due within one year of the consolidated balance sheet date that remained due within one year of the consolidated balance sheet date following the January 6, 2023 refinancing. As of January 6, 2023, future principal payments due under the Second A&R Loan Agreement are as follows (in thousands): Year Ending December 31 Total 2023 $ — 2024 5,070 2025 21,646 2026 5,784 Long-term debt $ 32,500 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Lease, Cost | The components of lease expense for the three years ended December 31, 2022, 2021 and 2020 were as follows (dollars in thousands): For the Year Ended December 31, Lease Cost 2022 2021 2020 Fixed operating lease cost $ 2,080 $ 2,087 $ 1,290 Short-term lease costs — 42 157 Total lease expense $ 2,080 $ 2,129 $ 1,447 Other information Operating cash flows from operating leases $ 1,354 $ 1,257 $ 3,820 Leased assets obtained in exchange for new operating lease liabilities $ — $ 1,343 $ 5,090 Weighted-average remaining lease term—operating leases 4.0 years 5.0 years 5.5 years Weighted-average discount rate—operating leases 11.4 % 11.3 % 11.2 % Sublease income $ 196 $ 196 $ 194 |
Lessee, Operating Lease, Liability, Maturity | Maturities of lease liabilities due under lease agreements that have commenced as of December 31, 2022 are as follows (in thousands): Maturity of lease liabilities Operating Leases 2023 $ 1,608 2024 1,374 2025 1,402 2026 1,332 2027 and thereafter 325 Total lease payments 6,041 Less: interest (1,240) Total operating lease liabilities as of December 31, 2022 $ 4,801 |
Preferred and Common Stock Wa_2
Preferred and Common Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of Outstanding Warrants Table | The following table provides a roll forward of outstanding warrants and pre-funded warrants for the purchase of shares of the Company’s common stock for the three years ended December 31, 2022: Number of warrants Weighted Average Exercise Price Weighted Average Contractual Term (Years) Outstanding and exercisable as of December 31, 2020 13,354,403 $ 13.52 3.72 Issued 2,058,032 Exercised (2,130,000) Expired (25.275) Outstanding and exercisable as of December 31, 2021 13,257,160 $ 7.96 2.72 Issued 104,531,257 Exercised (500,100) Expired (5,416,567) Outstanding and exercisable as of December 31, 2022 111,871,750 $ 1.86 4.53 |
Schedule of Stockholders' Equity Note, Warrants or Rights | As of December 31, 2022, the Company’s outstanding warrants and pre-funded warrants to purchase shares of common stock consisted of the following: Issuance Date Number of Shares of Common Stock Issuable Exercise Price Expiration Date October 25, 2016 5,155 $ 19.78 October 24, 2026 December 28, 2017 115,916 $ 19.78 December 28, 2027 September 12, 2018 20,220 $ 19.78 September 12, 2028 October 19, 2018 20,016 $ 19.78 October 19, 2028 March 13, 2019 5,000 $ 19.78 March 12, 2029 April 16, 2019 3,866,154 $ 13.20 April 15, 2024 November 29, 2019 1,250,000 $ 12.00 (a) n/a March 23, 2021 50,000 $ 8.70 (b) n/a November 9, 2021 2,008,032 $ 4.98 (c) n/a March 3, 2022 766,666 $ 1.80 (d) n/a July 6, 2022 13,276,279 $ 1.095 (e) n/a July 6, 2022 50,925,365 $ 1.095 July 6, 2027 December 9, 2022 32,762,947 $ 1.50 December 9, 2027 December 9, 2022 6,800,000 $ 1.10 (f) n/a 111,871,750 (a) In November 2019, the Company received $11.999 per pre-funded warrant, or $21.0 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.001 per pre-funded warrant; (b) In March 2021, the Company received $8.69 per pre-funded warrant, or $435 thousand in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.01 per pre-funded warrant; (c) In November 2021, the Company received $4.97 per pre-funded warrant, or $10.0 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.01 per pre-funded warrant; (d) In March 2022, the Company received $1.79 per pre-funded warrant, or $1.40 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.01 per pre-funded warrant; ( e) In July 2022, the Company received $1.094 per pre-funded warrant, or $14.5 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.001 per pre-funded warrant; and (f) In December 2022, the Company received $1.099 per pre-funded warrant, or $7.5 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.001 per pre-funded warrant. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Option Valuation | The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant-date fair value of stock options granted: Year Ended 2022 2021 2020 Risk-free interest rate 3.4 % 1.0 % 0.6 % Expected term (in years) 6.06 5.96 6.01 Expected volatility 96.0 % 97.3 % 94.9 % Expected dividend yield 0 % 0 % 0 % |
Summary of Stock Option Activity | The following table summarizes the Company’s stock option activity for the twelve months ended December 31, 2022: Number of Shares Weighted Weighted Average Contractual Term (in Years) Aggregate Intrinsic Value (in Thousands) Outstanding as of December 31, 2021 1,916,051 $ 10.01 7.8 $ — Granted 759,200 1.76 Forfeited (653,771) 9.75 Outstanding as of December 31, 2022 2,021,480 $ 6.99 6.5 $ 1 Exercisable as of December 31, 2022 1,114,604 $ 9.93 6.3 $ — Vested and expected to vest as of December 31, 2022 1,722,110 $ 7.77 7.3 $ — |
Share-based Payment Arrangement, Restricted Stock and Restricted Stock Unit, Activity | The following table summarizes the Company’s restricted stock activity for the twelve months ended December 31, 2022: Number of Shares Unvested at December 31, 2021 925,101 Granted 1,814,425 Vested (384,814) Forfeited (674,149) Unvested at December 31, 2022 1,680,563 |
Summary of Stock-Based Compensation Expense Classification | Stock-based compensation expense was classified in the consolidated statements of operations as follows: Year Ended 2022 2021 2020 Research and development expense $ 2,534 $ 2,723 $ 2,316 Selling, general and administrative expense 2,665 3,457 3,112 Total stock-based compensation $ 5,199 $ 6,180 $ 5,428 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign | Loss before the provision for income taxes for the years ended December 31, 2022, 2021 and 2020 consisted of the following: Year Ended December 31, (in thousands) 2022 2021 2020 United States $ (94,742) $ (89,865) $ (62,539) Foreign (Austria) 903 1,186 556 $ (93,839) $ (88,679) $ (61,983) |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the U.S. federal statutory income tax rate to the Company's effective income tax rate is as follows: Year Ended December 31, 2022 2021 2020 U.S. federal statutory income tax rate (21.0) % (21.0) % (21.0) % State income taxes, net of federal benefit (5.5) (5.4) (5.9) Research and development tax credits (1.0) (0.9) (1.1) Other permanent differences 3.0 3.7 0.9 Change in deferred tax asset valuation allowance 23.2 23.7 27.2 Other 1.3 (0.1) 0.1 Effective income tax rate — % — % 0.2 % |
Schedule of Deferred Tax Assets and Liabilities | Net deferred tax assets as of December 31, 2022 and 2021 consisted of the following: December 31, (in thousands) 2022 2021 Net operating loss carryforwards $ 107,296 $ 101,863 Research and development tax credit carryforwards 6,694 5,444 Capitalized research and development expenses 16,004 1,760 Lease liabilities 1,016 1,243 Other 3,604 3,372 Total deferred tax assets 134,614 113,682 Valuation allowance (133,112) (111,835) Deferred tax assets, net of valuation allowance $ 1,502 $ 1,847 Right of use assets 1,502 1,847 Total deferred tax liabilities $ 1,502 $ 1,847 Total deferred tax assets, net $ — $ — |
Summary of Valuation Allowance | Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2022, 2021 and 2020 related primarily to the increases in net operating loss carryforwards and research and development tax credit carryforwards and were as follows: Year Ended December 31, (in thousands) 2022 2021 2020 Valuation allowance, beginning of year $ (111,835) $ (92,197) $ (73,410) Increases recorded to income tax provision (21,277) (19,638) (18,787) Valuation allowance, end of year $ (133,112) $ (111,835) $ (92,197) |
Schedule of Unrecognized Tax Benefits Roll Forward | The following table summarizes the Company’s reserve for uncertain tax positions for the three years ended December 31, 2022: (in millions) Reserve for Uncertain Tax Position Balance as of December 31, 2020 $ 0.3 Settlement of unrecognized tax benefit (0.1) Balance as of December 31, 2021 0.2 Balance as of December 31, 2022 $ 0.2 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | Basic and diluted net loss per share attributable to common stockholders was calculated as follow: Year Ended (in thousands, except per share data) 2022 2021 2020 Numerator: Net loss $ (93,867) $ (88,696) $ (62,131) Deemed dividend as a result of Class B Warrant price reset (2,546) (13,943) — Net loss attributable to common stockholders $ (96,413) $ (102,639) $ (62,131) Denominator: Weighted average shares of common stock—basic and diluted 63,526 25,749 20,077 Net loss per share attributable to common stockholders— basic and diluted $ (1.52) $ (3.99) $ (3.09) |
Schedule of Anti-dilutive Securities Excluded from Computation of Diluted Net Loss per Share Attributable to Common Stockholders | The Company excluded the following potential shares of common stock from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Year Ended 2022 2021 2020 Options to purchase common stock 2,021,480 1,916,051 1,874,514 Unvested restricted stock units 1,680,563 925,101 572,460 Warrants to purchase common stock (excluding prefunded warrants, which are included in basic shares outstanding) 87,720,773 9,449,128 9,474,403 91,422,816 12,290,280 11,921,377 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Details) - USD ($) $ in Thousands | Mar. 18, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Restructuring Cost and Reserve [Line Items] | ||||
Cash and cash equivalents | $ 121,718 | $ 81,787 | $ 78,708 | |
Accumulated deficit | $ 376,738 | $ 282,871 | ||
Proceeds from common stock issuance | $ 55,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Restricted Cash and Cash Equivalents Items [Line Items] | |||
Other assets | $ 1,025 | $ 1,321 | $ 1,730 |
Restricted Cash | 1,310 | 1,321 | |
Restricted cash, current (included within prepaid expenses and other current assets) | $ 285 | $ 0 | $ 264 |
Restricted Cash, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other assets | Other assets | |
Letter of credit security: Waltham lease | Letter of Credit | |||
Restricted Cash and Cash Equivalents Items [Line Items] | |||
Other assets | $ 250 | $ 250 | |
Letter of credit security: Vienna Austria lease | Letter of Credit | |||
Restricted Cash and Cash Equivalents Items [Line Items] | |||
Other assets | 205 | 216 | |
Letter of credit security: Boston lease | Letter of Credit | |||
Restricted Cash and Cash Equivalents Items [Line Items] | |||
Other assets | $ 855 | $ 855 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 121,718 | $ 81,787 | $ 78,708 | |
Restricted cash, current (included within prepaid expenses and other current assets) | 285 | 0 | 264 | |
Other assets | 1,025 | 1,321 | 1,730 | |
Total cash, cash equivalents and restricted cash | $ 123,028 | $ 83,108 | $ 80,702 | $ 128,086 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Property, Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Office furniture | Minimum | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Office furniture | Maximum | |
Property, Plant and Equipment [Line Items] | |
Useful life | 7 years |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Laboratory equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Laboratory equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Useful life | 10 years |
Leasehold improvements | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 10 years |
Summary of Significant Policies
Summary of Significant Policies - Additional Information (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) reporting_unit | Dec. 31, 2020 USD ($) | Dec. 31, 2021 USD ($) | |
Property, Plant and Equipment [Line Items] | |||
Other assets | $ 1,025 | $ 1,730 | $ 1,321 |
Number of reporting units | reporting_unit | 1 | ||
Currency translation adjustments | $ (119) | ||
Hercules First Amended Loan Agreement | |||
Property, Plant and Equipment [Line Items] | |||
Debt Instrument, Debt Covenant, Minimum Cash Required | $ 20,000 |
License, Collaboration, and F_2
License, Collaboration, and Funding Agreements - Genzyme Agreement (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Payment on obligation under license agreement | $ 900,000 | ||
Genzyme Agreement | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Milestone payments | $ 25,000,000 | ||
Payment on obligation under license agreement | $ 0 | $ 0 |
License, Collaboration, and F_3
License, Collaboration, and Funding Agreements - Georgetown Agreement (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Payment on obligation under license agreement | $ 900,000 | |||
Georgetown | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
One time upfront payment | $ 50,000 | |||
Payments made | $ 800,000 | |||
Termination period | 60 days | |||
Payment on obligation under license agreement | $ 0 | 0 | $ 0 | |
Payment obligation | $ 0 | $ 0 | $ 0 |
License, Collaboration, and F_4
License, Collaboration, and Funding Agreements - Beth Israel Deaconess Medical Center Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2020 | Dec. 31, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Payment on obligation under license agreement | $ 900,000 | ||||
Bidmc Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
One time upfront payment | $ 20,000 | ||||
Payment on obligation under license agreement | $ 0 | $ 0 | $ 0 | ||
DFCI | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
One time upfront payment | $ 25,000 | ||||
Payment on obligation under license agreement | $ 32,300,000 | ||||
Collaborative Agreement , Expense Reimbursement | $ 35,000 | ||||
Collaborative Arrangement, Obligation, Percentage | 25% | ||||
Collaborative agreement, future expected annual fees, year one through three | $ 10,000 | ||||
Collaborative agreement, future expected annual fees, year four through six | 40,000 | ||||
Collaborative agreement, future expected annual fees, thereafter | $ 50,000 |
License, Collaboration, and F_5
License, Collaboration, and Funding Agreements - Research and Development Incentive Program (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Other income (expense) | $ (4,197) | $ 426 | $ 905 |
Research and Development Incentive Program | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Amount due under incentive receivable plan | 1,200 | 700 | |
Other income (expense) | 500 | $ 800 | $ 500 |
Abbisko Agreement | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Potential milestone payments receivable | $ 214,000 | ||
X4 Austria | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Reimbursement rate for research and development | 0.14 |
License, Collaboration, and F_6
License, Collaboration, and Funding Agreements (Details) - Abbisko Agreement $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Potential milestone payments receivable | $ 214,000 |
Revenues | $ 3,000 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities - Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Statement of Financial Position [Extensible Enumeration] | Other liabilities | Other liabilities |
Fair Value, Recurring | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Cash equivalents—money market funds | $ 73,028 | $ 47,793 |
Fair value of derivative liability | 23,141 | |
Embedded derivative liability | 821 | |
Fair Value, Recurring | Embedded derivative liability | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of derivative liability | 10 | |
Embedded derivative liability | 821 | |
Fair Value, Recurring | Warrant | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of derivative liability | 23,131 | |
Level 1 | Fair Value, Recurring | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Cash equivalents—money market funds | 70,170 | 20,000 |
Fair value of derivative liability | 0 | |
Embedded derivative liability | 0 | |
Level 1 | Fair Value, Recurring | Embedded derivative liability | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of derivative liability | 0 | |
Embedded derivative liability | 0 | |
Level 1 | Fair Value, Recurring | Warrant | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of derivative liability | ||
Level 2 | Fair Value, Recurring | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Cash equivalents—money market funds | 2,858 | 27,793 |
Fair value of derivative liability | 0 | |
Embedded derivative liability | 0 | |
Level 2 | Fair Value, Recurring | Embedded derivative liability | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of derivative liability | 0 | |
Embedded derivative liability | 0 | |
Level 2 | Fair Value, Recurring | Warrant | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of derivative liability | ||
Level 3 | Fair Value, Recurring | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Cash equivalents—money market funds | 0 | 0 |
Fair value of derivative liability | 23,141 | |
Embedded derivative liability | 821 | |
Level 3 | Fair Value, Recurring | Embedded derivative liability | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of derivative liability | 10 | |
Embedded derivative liability | $ 821 | |
Level 3 | Fair Value, Recurring | Warrant | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of derivative liability | $ 23,131 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Jun. 30, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | |
Hercules Amended and Restated Loan Agreement | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Interest rate | 8.75% | ||
Fair Value, Recurring | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Fair value of derivative liability | $ 23,141 | ||
Embedded derivative liability | $ 821 | ||
Fair Value, Recurring | Embedded derivative liability | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Fair value of derivative liability | 10 | ||
Embedded derivative liability | 821 | ||
Level 3 | Fair Value, Recurring | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Fair value of derivative liability | 23,141 | ||
Embedded derivative liability | 821 | ||
Level 3 | Fair Value, Recurring | Embedded derivative liability | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Fair value of derivative liability | $ 10 | ||
Embedded derivative liability | $ 821 |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities -Aggregate Fair Value of Warrant and Derivative Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Reclassifications of Temporary to Permanent Equity | $ (38,754) | |
Level 3 | Embedded derivative liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 821 | $ 455 |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Issuances | ||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Period Increase (Decrease) | (811) | 366 |
Ending balance | 10 | 821 |
Level 3 | Warrant | PIPE Warrant | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | 0 |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Issuances | 41,249 | |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Period Increase (Decrease) | (2,495) | 0 |
Reclassifications of Temporary to Permanent Equity | (38,754) | |
Ending balance | 0 | 0 |
Level 3 | Warrant | Class C Warrants | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | 0 |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Issuances | 21,526 | |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Period Increase (Decrease) | 1,605 | 0 |
Ending balance | $ 23,131 | $ 0 |
Fair Value of Financial Asset_6
Fair Value of Financial Assets and Liabilities - Assumptions (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||||
Dec. 07, 2022 | Jul. 06, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||
Risk-free interest rate | 3.40% | 1% | 0.60% | ||
Expected term (in years) | 6 years 21 days | 5 years 11 months 15 days | 6 years 3 days | ||
Expected volatility | 96% | 97.30% | 94.90% | ||
Expected dividend yield | 0% | 0% | 0% | ||
Warrant | |||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||||
Share Price | $ 0.93 | $ 0.99 | |||
Risk-free interest rate | 3.75% | 3.95% | 4% | ||
Expected term (in years) | 5 years | 5 years 10 months 9 days | 4 years 11 months 1 day | ||
Expected volatility | 101.80% | 96.96% | 101.70% | ||
Expected dividend yield | 0% | 0% | 0% | ||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability Value | $ 41.2 |
Fair Value of Financial Asset_7
Fair Value of Financial Assets and Liabilities - Goodwill Rollforward (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |||
Goodwill, Gross | $ 27,109 | $ 27,109 | |
Goodwill, Impaired, Accumulated Impairment Loss | (9,758) | $ (9,758) | 0 |
Goodwill | 17,351 | 17,351 | 27,109 |
Goodwill [Roll Forward] | |||
Goodwill, beginning balance | 17,351 | 27,109 | |
Goodwill impairment | 0 | (9,758) | 0 |
Goodwill, ending balance | $ 17,351 | $ 17,351 | $ 27,109 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 2,332 | $ 2,238 | |
Less: Accumulated depreciation and amortization | (1,228) | (724) | |
Property, plant and equipment, net | 1,104 | 1,514 | |
Depreciation and amortization expense | 513 | 499 | $ 351 |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 228 | 228 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 1,268 | 1,251 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 173 | 150 | |
Software | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 24 | 33 | |
Lab equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 639 | $ 576 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Income and Expenses [Abstract] | ||
Accrued employee compensation and benefits | $ 6,592 | $ 5,417 |
Accrued external research and development expenses | 3,906 | 1,507 |
Accrued professional fees | 571 | 632 |
Accrued deferred financing fees | 591 | 25 |
Other | 374 | 289 |
Accrued expenses | $ 12,034 | $ 7,870 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long-Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Principal amount of long-term debt | $ 32,500 | $ 32,500 |
Debt Instrument, Unamortized Discount (Premium), Net | (196) | 277 |
Cumulative accrual of end of term payments | 1,315 | 1,157 |
Long-Term Debt, Including Accretion | 33,619 | 33,934 |
Long-term Debt, Current Maturities | (1,315) | (795) |
Long-term debt, net of current portion | $ 32,304 | $ 33,139 |
Long-Term Debt - Narrative (Det
Long-Term Debt - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | 30 Months Ended | ||||
Apr. 01, 2026 | Jul. 01, 2024 | Jul. 01, 2023 | Jun. 30, 2019 | Dec. 31, 2022 | Mar. 31, 2021 | Dec. 21, 2020 | |
Line of Credit Facility [Line Items] | |||||||
Principal payments | $ 800,000 | ||||||
Hercules Loan Agreement | |||||||
Line of Credit Facility [Line Items] | |||||||
Proceeds from line of credit | $ 32,500,000 | ||||||
Hercules First Amended Loan Agreement | |||||||
Line of Credit Facility [Line Items] | |||||||
Maximum borrowing capacity | $ 50,000,000 | ||||||
Debt Instrument, Debt Covenant, Minimum Cash Required | $ 20,000,000 | ||||||
Hercules First Amended Loan Agreement | Discretionary Borrowings [Member] | |||||||
Line of Credit Facility [Line Items] | |||||||
Credit outstanding | 17,500,000 | ||||||
Hercules Amended and Restated Loan Agreement | |||||||
Line of Credit Facility [Line Items] | |||||||
Interest rate | 8.75% | ||||||
Increase in interest rate | 4% | ||||||
Hercules Amended and Restated Loan Agreement | Minimum | |||||||
Line of Credit Facility [Line Items] | |||||||
Variable interest rate | 3.75% | ||||||
Hercules Second Amended Loan Agreement | |||||||
Line of Credit Facility [Line Items] | |||||||
Effective interest rate | 13.50% | ||||||
Principal payments | $ 0 | ||||||
Payment premium percentage | 0.030 | ||||||
Hercules Second Amended Loan Agreement | Forecast | |||||||
Line of Credit Facility [Line Items] | |||||||
Periodic payment | $ 1,300,000 | $ 800,000 | $ 1,300,000 | ||||
Hercules Second Amended Loan Agreement | Min Cash Test Date 1 [Member] | |||||||
Line of Credit Facility [Line Items] | |||||||
Line of Credit, Covenant, Minimum Cash | $ 30,000,000 | ||||||
Hercules Second Amended Loan Agreement | Min Cash Test Date 2 [Member] | |||||||
Line of Credit Facility [Line Items] | |||||||
Line of Credit, Covenant, Minimum Cash | 20,000,000 | ||||||
Second A&R Loan Agreement | |||||||
Line of Credit Facility [Line Items] | |||||||
Maximum borrowing capacity | $ 32,500,000 | ||||||
Interest rate | 10.15% | ||||||
Debt Instrument, Debt Covenant, Minimum Cash Required | 20,000,000 | ||||||
Debt Instrument, Debt Covenant, Minimum Cash Required, Conditional Scenario | $ 10,000,000 | ||||||
Second A&R Loan Agreement | Minimum | |||||||
Line of Credit Facility [Line Items] | |||||||
Variable interest rate | 3.15% |
Long-Term Debt - Hercules Loan
Long-Term Debt - Hercules Loan Agreements (Details) - Hercules Loan Agreement - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Line of Credit Facility [Line Items] | |||
Interest expense | $ 3,989 | $ 3,642 | $ 2,686 |
Debt discount amortization | $ 918 | $ 756 | $ 531 |
Long-Term Debt - Future Princip
Long-Term Debt - Future Principal Payments (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Line of Credit Facility [Line Items] | |
2023 | $ 14,037 |
2024 | 19,779 |
Long-term debt, including end-of-term payments | 33,816 |
Second A&R Loan Agreement | |
Line of Credit Facility [Line Items] | |
2023 | 0 |
2024 | 5,070 |
2025 | 21,646 |
2026 | 5,784 |
Long-term debt, including end-of-term payments | $ 32,500 |
Leases (Details)
Leases (Details) $ in Thousands | 12 Months Ended | |||||
Sep. 01, 2020 USD ($) ft² | Nov. 11, 2019 USD ($) ft² | Mar. 13, 2019 USD ($) ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||||
Right-of-use assets | $ 7,229 | $ 8,710 | ||||
Lessee, Operating Lease, Security Deposit, Line Of Credit | 900 | |||||
Operating lease, liability | 4,801 | |||||
Lease liabilities | 3,603 | 4,776 | ||||
Current portion of lease liability | 1,198 | 1,075 | ||||
Right-of-use asset, amortization term | 5 years | |||||
Fixed operating lease cost | 2,080 | 2,087 | $ 1,290 | |||
Short-term lease costs | 0 | 42 | 157 | |||
Total lease expense | 2,080 | 2,129 | 1,447 | |||
Operating cash flows from operating leases | 1,354 | 1,257 | 3,820 | |||
Leased assets obtained in exchange for new operating lease liabilities | $ 0 | $ 1,343 | $ 5,090 | |||
Weighted-average remaining lease term—operating leases | 4 years | 5 years | 5 years 6 months | |||
Weighted-average discount rate—operating leases | 11.40% | 11.30% | 11.20% | |||
Sublease income | $ 196 | $ 196 | $ 194 | |||
Waltham Lease | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Office space area | ft² | 6,000 | |||||
Base rent | $ 300 | |||||
Term of contract | 5 years | |||||
Boston Lease | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Current Office Space Under Lease Agreement | ft² | 28,000 | |||||
Renewal term | 5 years | |||||
Lease not yet commenced, amount | $ 1,000 | |||||
New Vienna Lease | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Office space area | ft² | 1,200 | |||||
Base rent | $ 300 | |||||
Term of contract | 7 years |
Leases - Schedule of Components
Leases - Schedule of Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lease Cost | |||
Fixed operating lease cost | $ 2,080 | $ 2,087 | $ 1,290 |
Short-term lease costs | 0 | 42 | 157 |
Total lease expense | 2,080 | 2,129 | 1,447 |
Other information | |||
Operating cash flows from operating leases | 1,354 | 1,257 | 3,820 |
Leased assets obtained in exchange for new operating lease liabilities | $ 0 | $ 1,343 | $ 5,090 |
Weighted-average remaining lease term—operating leases | 4 years | 5 years | 5 years 6 months |
Weighted-average discount rate—operating leases | 11.40% | 11.30% | 11.20% |
Sublease income | $ 196 | $ 196 | $ 194 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands | Dec. 31, 2022 USD ($) |
Leases [Abstract] | |
2023 | $ 1,608 |
2024 | 1,374 |
2025 | 1,402 |
2026 | 1,332 |
2027 and thereafter | 325 |
Total lease payments | 6,041 |
Less: interest | (1,240) |
Operating Lease, Liability | $ 4,801 |
Preferred and Common Stock Wa_3
Preferred and Common Stock Warrants - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||||||||
Nov. 26, 2019 | Apr. 16, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 09, 2022 | Jul. 06, 2022 | Mar. 03, 2022 | Nov. 30, 2021 | Nov. 09, 2021 | Mar. 23, 2021 | Dec. 31, 2020 | Nov. 29, 2019 | |
Class of Stock [Line Items] | ||||||||||||
Class Of Warrant Or Right Issued | 104,531,257 | 2,058,032 | ||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 1.79 | |||||||||||
Warrant expiration period | 30 days | |||||||||||
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||||
Class Of Warrant Or Right. Aggregate Proceeds From Warrants Issued | $ 7,500 | $ 14,500 | $ 1,400 | $ 10,000 | $ 435 | $ 21,000 | ||||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | $ 0.001 | $ 0.001 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.001 | ||||||
Class of warrant or right, outstanding (in shares) | 111,871,750 | 13,257,160 | 13,354,403 | |||||||||
Minimum | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | 0.001 | |||||||||||
Maximum | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | 0.01 | |||||||||||
Funded | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Convertible preferred stock exercise price (in dollars per share) | 1,099 | $ 1.094 | $ 1,790 | $ 4.97 | $ 8.69 | |||||||
Pre Funded Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Convertible preferred stock exercise price (in dollars per share) | 11.999 | |||||||||||
Issuance On March 23, 2021 | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 8.70 | |||||||||||
Class of warrant or right, outstanding (in shares) | 50,000 | |||||||||||
Issuance on November Nine Two Thousand Twenty One | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 4.98 | |||||||||||
Class of warrant or right, outstanding (in shares) | 2,008,032 | |||||||||||
Class A Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Class Of Warrant Or Right Issued | 3,900,000 | |||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 13.20 | |||||||||||
Class B Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 15 | |||||||||||
Number of warrants issued (in shares) | 5,416,667 | |||||||||||
Class C Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 1.50 | |||||||||||
Number of warrants issued (in shares) | 65,525,894 |
Preferred and Common Stock Wa_4
Preferred and Common Stock Warrants - Schedule of Outstanding Warrants (Detail) - $ / shares | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 03, 2022 | |
Number of warrants | ||||
Outstanding and exercisable as of December 31, 2020 | 13,257,160 | 13,354,403 | ||
Class Of Warrant Or Right Issued | 104,531,257 | 2,058,032 | ||
Exercised (in shares) | (500,100) | (2,130,000) | ||
Outstanding and exerciseable, Number of warrants, ending balance (in shares) | 111,871,750 | 13,257,160 | 13,354,403 | |
Issued | 5,416,567 | 25,275 | ||
Weighted Average Exercise Price | ||||
Outstanding and exercisable warrants to purchase preferred shares, beginning balance (in dollars per share) | $ 7.96 | $ 13.52 | ||
Outstanding and exercisable, ending balance (in dollars per share) | $ 1.86 | $ 7.96 | $ 13.52 | |
Weighted Average Contractual Term (Years) | 4 years 6 months 10 days | 2 years 8 months 19 days | 3 years 8 months 19 days | |
Class of Warrant or Right [Line Items] | ||||
Class of warrant or right, outstanding (in shares) | 111,871,750 | 13,257,160 | 13,354,403 | |
Convertible preferred stock exercise price (in dollars per share) | $ 1.79 | |||
Issuance on November 29, 2019 | ||||
Number of warrants | ||||
Outstanding and exerciseable, Number of warrants, ending balance (in shares) | 1,250,000 | |||
Class of Warrant or Right [Line Items] | ||||
Class of warrant or right, outstanding (in shares) | 1,250,000 | |||
Convertible preferred stock exercise price (in dollars per share) | $ 12 |
Preferred and Common Stock Wa_5
Preferred and Common Stock Warrants - Summary of Outstanding Warrants to Purchase Shares of Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2022 | Dec. 09, 2022 | Jul. 06, 2022 | Mar. 03, 2022 | Dec. 31, 2021 | Nov. 30, 2021 | Nov. 09, 2021 | Mar. 23, 2021 | Dec. 31, 2020 | Nov. 29, 2019 |
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 111,871,750 | 13,257,160 | 13,354,403 | |||||||
Exercise Price (in dollars per share) | $ 1.79 | |||||||||
Class Of Warrant Or Right. Aggregate Proceeds From Warrants Issued | $ 7,500 | $ 14,500 | $ 1,400 | $ 10,000 | $ 435 | $ 21,000 | ||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | $ 0.001 | $ 0.001 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.001 | ||||
Funded | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Exercise Price (in dollars per share) | $ 1,099 | $ 1.094 | $ 1,790 | $ 4.97 | $ 8.69 | |||||
Issuance On October 25, 2016 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 5,155 | |||||||||
Exercise Price (in dollars per share) | $ 19.78 | |||||||||
Issuance On December 28, 2017 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 115,916 | |||||||||
Exercise Price (in dollars per share) | $ 19.78 | |||||||||
Issuance On September 12, 2018 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 20,220 | |||||||||
Exercise Price (in dollars per share) | $ 19.78 | |||||||||
Issuance On October 19, 2018 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 20,016 | |||||||||
Exercise Price (in dollars per share) | $ 19.78 | |||||||||
Issuance On March 13, 2019 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 5,000 | |||||||||
Exercise Price (in dollars per share) | $ 19.78 | |||||||||
Issuance On April 16, 2019 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 3,866,154 | |||||||||
Exercise Price (in dollars per share) | $ 13.20 | |||||||||
Issuance on November 29, 2019 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 1,250,000 | |||||||||
Exercise Price (in dollars per share) | $ 12 | |||||||||
Issuance On March 23, 2021 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 50,000 | |||||||||
Exercise Price (in dollars per share) | $ 8.70 | |||||||||
Issuance on November Nine Two Thousand Twenty One | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 2,008,032 | |||||||||
Exercise Price (in dollars per share) | $ 4.98 | |||||||||
Issuance on March 3 2022 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 766,666 | |||||||||
Exercise Price (in dollars per share) | $ 1.80 | |||||||||
Issuance on July 2022 1 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 13,276,279 | |||||||||
Exercise Price (in dollars per share) | $ 1.095 | |||||||||
Issuance on July 6 2022 2 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 50,925,365 | |||||||||
Exercise Price (in dollars per share) | $ 1.095 | |||||||||
Issuance on December 9 2022 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 32,762,947 | |||||||||
Exercise Price (in dollars per share) | 1.50 | |||||||||
Issuance on December 9 2022 2 | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of warrant or right, outstanding (in shares) | 6,800,000 | |||||||||
Exercise Price (in dollars per share) | $ 1.10 | |||||||||
Pre Funded Warrant | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Exercise Price (in dollars per share) | $ 11.999 |
Common Stock, Redeemable Comm_2
Common Stock, Redeemable Common Stock and Convertible Preferred Stock (converted to Common Stock) - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||||||||
Dec. 07, 2022 | Mar. 03, 2022 | Jan. 14, 2022 | Mar. 23, 2021 | Mar. 18, 2021 | Oct. 14, 2020 | Aug. 07, 2020 | Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 09, 2022 | Sep. 01, 2022 | Jul. 06, 2022 | Nov. 09, 2021 | Dec. 31, 2020 | Nov. 29, 2019 | Nov. 26, 2019 | |
Class of Stock [Line Items] | |||||||||||||||||
Common stock, authorized (in shares) | 500,000,000 | 125,000,000 | 500,000,000 | ||||||||||||||
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 | |||||||||||||||
Cash dividends | $ 0 | ||||||||||||||||
Class of warrant or right, outstanding (in shares) | 111,871,750 | 13,257,160 | 13,354,403 | ||||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 1.79 | ||||||||||||||||
Proceeds from common stock issuance | $ 55,000,000 | ||||||||||||||||
Stock Repurchased and Retired During Period, Value | $ 0 | ||||||||||||||||
Sale of Stock, Purchase Agreement, Shares Issued | 230,414 | ||||||||||||||||
Purchase Agreement, Shares Purchased | 1,382,488 | ||||||||||||||||
Accelerated Share Repurchases, Initial Price Paid Per Share | $ 2.17 | ||||||||||||||||
Payments for Securities Purchased under Agreements to Resell | $ 3,000,000 | ||||||||||||||||
Warrants and Rights Outstanding, Term | 5 years | ||||||||||||||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | 0.01 | $ 0.01 | $ 0.001 | $ 0.001 | $ 0.01 | $ 0.001 | |||||||||||
Warrants and Rights Outstanding, Transaction Fees | $ 2,900,000 | ||||||||||||||||
Warrant | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings | $ (2,500,000) | ||||||||||||||||
Warrant | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability Value | $ 41,200,000 | ||||||||||||||||
Pre Funded Warrant | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability Value | $ 13,500,000 | ||||||||||||||||
Equity Unit Purchase Agreements | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Purchase agreement, term | 36 months | ||||||||||||||||
Lincoln Park Capital Fund, LLC | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Long-term Purchase Commitment, Amount | $ 50,000,000 | ||||||||||||||||
Funded | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 1,790 | $ 8.69 | $ 1,099 | $ 1.094 | $ 4.97 | ||||||||||||
Issuance On March 23, 2021 | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Class of warrant or right, outstanding (in shares) | 50,000 | ||||||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 8.70 | ||||||||||||||||
Pre Funded Warrant | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 11.999 | ||||||||||||||||
Redeemable Common Stock | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Stock issued (in shares) | 229,885 | ||||||||||||||||
Stock Repurchased and Retired During Period, Value | $ 2,000,000 | $ 1,875 | |||||||||||||||
Issuance On March 23, 2021 | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Stock issued (in shares) | 6,271,836 | ||||||||||||||||
Issuance On March 23, 2021 | Redeemable Preferred Stock | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Stock issued (in shares) | 229,885 | ||||||||||||||||
Pre Funded Warrant | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Class of warrant or right, outstanding (in shares) | 766,666 | ||||||||||||||||
Pre Funded Warrant | Issuance On March 23, 2021 | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Class of warrant or right, outstanding (in shares) | 50,000 | ||||||||||||||||
Q1 2022 PIPE | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Stock issued (in shares) | 900,000 | ||||||||||||||||
Sale price (in dollars per share) | $ 1.80 | ||||||||||||||||
Proceeds from Issuance of Warrants | $ 3,000,000 | ||||||||||||||||
Q2 2022 Private Placement | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Stock issued (in shares) | 37,649,086 | ||||||||||||||||
Proceeds from common stock issuance | $ 55,700,000 | ||||||||||||||||
Sale price (in dollars per share) | $ 1.095 | ||||||||||||||||
Number of warrants issued (in shares) | 50,925,365 | ||||||||||||||||
Warrants and Rights Outstanding, Term | 60 months | ||||||||||||||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | $ 0.001 | ||||||||||||||||
Q2 2022 Private Placement | Pre Funded Warrant | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 1.094 | ||||||||||||||||
Number of warrants issued (in shares) | 13,276,279 | ||||||||||||||||
Q4 2022 Public Offering | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Stock issued (in shares) | 52,300,000 | ||||||||||||||||
Proceeds from common stock issuance | $ 65,100,000 | ||||||||||||||||
Sale price (in dollars per share) | $ 1.50 | ||||||||||||||||
Number of warrants issued (in shares) | 32,762,947 | ||||||||||||||||
Q4 2022 Public Offering | Class C Warrants | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Sale price (in dollars per share) | $ 1.10 | ||||||||||||||||
Q4 2022 Public Offering | Pre Funded Warrant | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Convertible preferred stock exercise price (in dollars per share) | $ 1.099 | ||||||||||||||||
Number of warrants issued (in shares) | 6,800,000 | ||||||||||||||||
Sales Agents [Member] | Common Stock | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Number of shares authorized in transaction, amount | $ 50,000,000 | ||||||||||||||||
Common Stocks, Including Additional Paid in Capital | $ 14,300,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Jan. 01, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Maximum percentage of fair value of common stock | 100% | |||
Exercises in period, intrinsic value | $ 0 | $ 13 | $ 42 | |
Options granted, weighted average grant date fair value (in dollars per share) | $ 1.38 | $ 5.17 | $ 6.12 | |
Total stock-based compensation | $ 5,199 | $ 6,180 | $ 5,428 | |
Incentive Stock Options and Restricted Stock Awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares based compensation, vested period (in years) | 4 years | |||
Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation, restricted stock units granted (in shares) | 1,814,425 | |||
Share based compensation, restricted stock units granted (in dollars per share) | $ 2.09 | |||
Unrecognized compensation cost of stock based awards | $ 4,400 | |||
Unrecognized compensation cost of stock based awards, recognition period | 1 year 6 months | |||
Stock Appreciation Rights (SARs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 373 | |||
Two Thousand Seventeen Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, reserved for future issuance (in shares) | 4,800,000 | 298,000 | ||
Aggregate intrinsic value, options exercised | 4% | |||
Two Thousand Seventeen Equity Incentive Plan | Employee Stock Purchase Plans | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation arrangement by share-based payment award, shares issued in period (in shares) | 204,903 | |||
Share-based compensation arrangement by share-based payment award, number of shares available for grant (in shares) | 64,000 | |||
Share-based compensation arrangement by share-based payment award, number of additional shares authorized (in shares) | 85,000 | |||
Two Thousand Nineteen Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, authorized (in shares) | 2,300,000 | |||
Common stock, reserved for future issuance (in shares) | 1,300,000 | |||
Two Thousand Fifteen Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, reserved for future issuance (in shares) | 19,000 | |||
Minimum | Non-Statutory Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares based compensation, vested period (in years) | 3 years | |||
Maximum | Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expiration period (in years) | 10 years | |||
Maximum | Non-Statutory Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares based compensation, vested period (in years) | 4 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Shares | ||
Outstanding, beginning balance (in shares) | 1,916,051 | |
Granted, (in shares) | 759,200 | |
Forfeited (in shares) | (653,771) | |
Outstanding, ending balance (in shares) | 2,021,480 | 1,916,051 |
Exercisable, ending balance (in shares) | 1,114,604 | |
Vested and expected to vest, ending balance (in shares) | 1,722,110 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance (in dollars per share) | $ 10.01 | |
Granted (in dollars per share) | 1.76 | |
Forfeited (in dollars per share) | 9.75 | |
Outstanding, ending balance (in dollars per share) | 6.99 | $ 10.01 |
Exercisable (in dollars per share) | 9.93 | |
Vested and expected to vest (in dollars per share) | $ 7.77 | |
Weighted Average Contractual Term (in Years) | ||
Outstanding | 6 years 6 months | 7 years 9 months 18 days |
Exercisable | 6 years 3 months 18 days | |
Vested and expected to vest | 7 years 3 months 18 days | |
Aggregate Intrinsic Value (in Thousands) | ||
Outstanding beginning balance | $ 0 | |
Outstanding ending balance | 1 | $ 0 |
Exercisable | 0 | |
Vested and expected to vest | $ 0 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) | 12 Months Ended |
Dec. 31, 2022 shares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Nonvested beginning balance (in shares) | 925,101 |
Granted (in shares) | 1,814,425 |
Vested (in shares) | (384,814) |
Forfeited (in shares) | (674,149) |
Nonvested ending balance (in shares) | 1,680,563 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock-Based Compensation Expense Classification (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation | $ 5,199 | $ 6,180 | $ 5,428 |
Research and development expense | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation | 2,534 | 2,723 | 2,316 |
Selling, general and administrative expense | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation | $ 2,665 | $ 3,457 | $ 3,112 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Valuation (Details) | 12 Months Ended | ||||
Dec. 07, 2022 | Jul. 06, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Risk-free interest rate | 3.40% | 1% | 0.60% | ||
Expected term (in years) | 6 years 21 days | 5 years 11 months 15 days | 6 years 3 days | ||
Expected volatility | 96% | 97.30% | 94.90% | ||
Expected dividend yield | 0% | 0% | 0% | ||
Warrant | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Risk-free interest rate | 3.75% | 3.95% | 4% | ||
Expected term (in years) | 5 years | 5 years 10 months 9 days | 4 years 11 months 1 day | ||
Expected volatility | 101.80% | 96.96% | 101.70% | ||
Expected dividend yield | 0% | 0% | 0% | ||
Expected Forfeiture Rate | 22% |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (94,742) | $ (89,865) | $ (62,539) |
Foreign (Austria) | 903 | 1,186 | 556 |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest | $ (93,839) | $ (88,679) | $ (61,983) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Effective Income Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal statutory income tax rate | 21% | 21% | 21% |
State income taxes, net of federal benefit | (5.50%) | (5.40%) | (5.90%) |
Research and development tax credits | (1.00%) | (0.90%) | (1.10%) |
Other permanent differences | 3% | 3.70% | 0.90% |
Change in deferred tax asset valuation allowance | 23.20% | 23.70% | 27.20% |
Other | 1.30% | (0.10%) | 0.10% |
Effective income tax rate | 0% | 0% | 0.20% |
Income Taxes - Deferred Income
Income Taxes - Deferred Income Tax Asset (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Components of Deferred Tax Assets [Abstract] | ||
Net operating loss carryforwards | $ 107,296 | $ 101,863 |
Research and development tax credit carryforwards | 6,694 | 5,444 |
Capitalized research and development expenses | 16,004 | 1,760 |
Lease liabilities | 1,016 | 1,243 |
Other | 3,604 | 3,372 |
Total deferred tax assets | 134,614 | 113,682 |
Valuation allowance | (133,112) | (111,835) |
Deferred tax assets, net of valuation allowance | 1,502 | 1,847 |
Right of use assets | 1,502 | 1,847 |
Total deferred tax liabilities | 1,502 | 1,847 |
Total deferred tax assets, net | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Contingency [Line Items] | |||
Tax cuts and jobs act, capitalized costs | $ 59,000 | ||
Tax cuts and jobs act, costs amortized | 5,300 | ||
Tax cuts and jobs act, deferred tax assets | 14,700 | ||
Unrecognized tax benefits | 200 | $ 200 | $ 300 |
Domestic Tax Authority | |||
Income Tax Contingency [Line Items] | |||
Operating loss carryforwards | 342,900 | ||
Operating loss carryforwards, not subject to expiration | 288,800 | ||
Deferred Tax Assets, Operating Loss Carryforwards, Subject to Expiration | 54,100 | ||
Unrecognized tax benefits | 200 | ||
State and Local Jurisdiction | |||
Income Tax Contingency [Line Items] | |||
Operating loss carryforwards | 336,500 | ||
Foreign Tax Authority | |||
Income Tax Contingency [Line Items] | |||
Operating loss carryforwards | 61,200 | ||
Research Tax Credit Carryforward | Domestic Tax Authority | |||
Income Tax Contingency [Line Items] | |||
Tax credit carryforward, amount | 5,200 | ||
Research Tax Credit Carryforward | State and Local Jurisdiction | |||
Income Tax Contingency [Line Items] | |||
Tax credit carryforward, amount | $ 1,900 |
Income Taxes - Deferred Tax Val
Income Taxes - Deferred Tax Valuation Allowance (Details) - SEC Schedule, 12-09, Valuation Allowance, Deferred Tax Asset [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Valuation allowance, beginning of year | $ (111,835) | $ (92,197) | $ (73,410) |
Increases recorded to income tax provision | (21,277) | (19,638) | (18,787) |
Valuation allowance, end of year | $ (133,112) | $ (111,835) | $ (92,197) |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Unrecognized tax benefits | $ 200 | $ 200 | $ 300 |
Unrecognized Tax Benefits, Increase Resulting from Acquisition | $ 100 |
Net Loss per Share - Summary of
Net Loss per Share - Summary of Basic and Diluted Net loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |||
Net income (loss) | $ (93,867) | $ (88,696) | $ (62,131) |
Deemed dividend as a result of Class B Warrant price reset | 2,546 | 13,943 | 0 |
Net loss attributable to common stockholders | $ (96,413) | $ (102,639) | $ (62,131) |
Weighted average shares of common stock outstanding - basic (in shares) | 63,526 | 25,749 | 20,077 |
Weighted average shares of common stock outstanding - diluted (in shares) | 63,526 | 25,749 | 20,077 |
Net loss per share attributable to common stockholders - basic (in dollars per share) | $ (1.52) | $ (3.99) | $ (3.09) |
Net loss per share attributable to common stockholders - diluted (in dollars per share) | $ (1.52) | $ (3.99) | $ (3.09) |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - $ / shares | 12 Months Ended | ||||
Apr. 16, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 03, 2022 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | |||||
Weighted average shares of common stock outstanding - basic (in shares) | 63,526,000 | 25,749,000 | 20,077,000 | ||
Weighted average shares of common stock outstanding - diluted (in shares) | 63,526,000 | 25,749,000 | 20,077,000 | ||
Convertible preferred stock exercise price (in dollars per share) | $ 1.79 | ||||
Pre Funded Warrant | |||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | |||||
Weighted average shares of common stock outstanding - basic (in shares) | 24,150,977 | ||||
Weighted average shares of common stock outstanding - diluted (in shares) | 24,150,977 | ||||
Minimum | Pre Funded Warrant | |||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | |||||
Convertible preferred stock exercise price (in dollars per share) | $ 0.01 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Anti-dilutive Securities Excluded from Computation of Diluted Net Loss per Share Attributable to Common Stockholders (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded form computation of diluted net loss per share (in shares) | 91,422,816 | 12,290,280 | 11,921,377 |
Warrant | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded form computation of diluted net loss per share (in shares) | 87,720,773 | 9,449,128 | 9,474,403 |
Equity Option | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded form computation of diluted net loss per share (in shares) | 2,021,480 | 1,916,051 | 1,874,514 |
Restricted Stock Units (RSUs) | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded form computation of diluted net loss per share (in shares) | 1,680,563 | 925,101 | 572,460 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Dec. 31, 2022 | Jan. 06, 2023 | Dec. 21, 2020 | |
Second A&R Loan Agreement | ||||
Subsequent Event [Line Items] | ||||
Maximum borrowing capacity | $ 32,500,000 | |||
Interest rate | 10.15% | |||
Debt Instrument, Debt Covenant, Minimum Cash Required | $ 20,000,000 | |||
Debt Instrument, Debt Covenant, Minimum Cash Required, Conditional Scenario | $ 10,000,000 | |||
Hercules Amended and Restated Loan Agreement | ||||
Subsequent Event [Line Items] | ||||
Increase in interest rate | 4% | |||
Interest rate | 8.75% | |||
Minimum | Second A&R Loan Agreement | ||||
Subsequent Event [Line Items] | ||||
Variable interest rate | 3.15% | |||
Minimum | Hercules Amended and Restated Loan Agreement | ||||
Subsequent Event [Line Items] | ||||
Variable interest rate | 3.75% | |||
Subsequent Event | Second A&R Loan Agreement | ||||
Subsequent Event [Line Items] | ||||
Maximum borrowing capacity | $ 32,500,000 |