Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
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 Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 69,235,074 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001501697 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 79,855 | $ 81,787 |
Research and development incentive receivable | 909 | 747 |
Prepaid expenses and other current assets | 4,954 | 5,344 |
Total current assets | 85,718 | 87,878 |
Property and equipment, net | 1,194 | 1,514 |
Goodwill | 17,351 | 17,351 |
Right-of-use assets | 7,606 | 8,710 |
Other assets | 1,537 | 1,723 |
Total assets | 113,406 | 117,176 |
Current liabilities: | ||
Accounts payable | 3,800 | 4,283 |
Accrued expenses | 9,128 | 7,870 |
Current portion of lease liability | 1,164 | 1,075 |
Current portion of long-term debt | 14,621 | 795 |
Total current liabilities | 28,713 | 14,023 |
Long-term debt, net of discount and current portion | 18,733 | 33,139 |
Lease liabilities | 3,799 | 4,776 |
Other liabilities | 312 | 826 |
Total liabilities | 51,557 | 52,764 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value, 500,000,000 and 125,000,000 shares authorized as of September 30, 2022 and December 31, 2021, respectively; 68,734,553 and 28,127,657 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 69 | 28 |
Additional paid-in capital | 409,533 | 347,374 |
Accumulated other comprehensive loss | (119) | (119) |
Accumulated deficit | (347,634) | (282,871) |
Total stockholders’ equity | 61,849 | 64,412 |
Total liabilities and stockholders’ equity | $ 113,406 | $ 117,176 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 500,000,000 | 125,000,000 |
Common stock, shares issued | 68,734,553 | 28,127,657 |
Common stock, shares outstanding | 68,734,553 | 28,127,657 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 14,110 | $ 13,188 | $ 42,044 | $ 38,485 |
Selling, general and administrative | 6,044 | 5,931 | 20,457 | 17,567 |
Gain (Loss) on Disposition of Assets | 0 | 0 | (509) | 0 |
Total operating expenses | 20,154 | 19,119 | 61,992 | 56,052 |
Loss from operations | (20,154) | (19,119) | (61,992) | (56,052) |
Other expense, net: | ||||
Interest income | 14 | 2 | 21 | 7 |
Interest expense | (1,018) | (920) | (2,849) | (2,717) |
Change in fair value of derivative liability | 0 | (62) | 511 | (36) |
Other (expense) income, net | (441) | (74) | (440) | 323 |
Total other expense, net | (1,445) | (1,054) | (2,757) | (2,423) |
Loss before provision for income taxes | (21,599) | (20,173) | (64,749) | (58,475) |
Provision for income taxes | (13) | 2 | 14 | 14 |
Net loss and comprehensive loss | (21,586) | (20,175) | (64,763) | (58,489) |
Deemed dividend on Class B Warrant price reset | (287) | 0 | (2,546) | (8,239) |
Net loss attributable to common stockholders | $ (21,873) | $ (20,175) | $ (67,309) | $ (66,728) |
Net loss per share attributable to common stockholders—basic | $ (0.26) | $ (0.76) | $ (1.32) | $ (2.71) |
Net loss per share attributable to common stockholders—diluted | $ (0.26) | $ (0.76) | $ (1.32) | $ (2.71) |
Weighted average shares of common stock outstanding—diluted | 83,211,000 | 26,609,000 | 50,976,000 | 24,667,000 |
Weighted average shares of common stock outstanding—basic | 83,211,000 | 26,609,000 | 50,976,000 | 24,667,000 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK, REDEEMABLE COMMON STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Redeemable Common Stock | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||
Redeemable Common Shares, Value | $ 0 | |||||
Redeemable common shares, beginning balance, shares at Dec. 31, 2020 | 0 | |||||
Convertible preferred shares, ending balance, shares at Mar. 31, 2021 | 229,885 | |||||
Beginning balance, shares at Dec. 31, 2020 | 16,305,731 | |||||
Beginning balance at Dec. 31, 2020 | $ 72,799 | $ 16 | $ 267,077 | $ (119) | $ (194,175) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock Issued During Period, Shares, New Issues | 229,885 | 6,041,951 | ||||
Stock Issued During Period, Value, New Issues | 49,640 | $ 1,875 | $ 7 | 49,633 | ||
Stock Issued During Period Shares Warrants Exercised | 1,072,887 | |||||
Stock Issued During Period Value Warrants Exercised | 1 | $ 1 | ||||
Exercise of stock options, shares | 5,860 | |||||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations | 40 | 40 | ||||
Stock-based compensation expense | 1,258 | 1,258 | ||||
Net loss | (18,676) | (18,676) | ||||
Ending balance, shares at Mar. 31, 2021 | 23,426,429 | |||||
Ending balance at Mar. 31, 2021 | 105,062 | $ 24 | 318,008 | (119) | (212,851) | |
Redeemable common shares, beginning balance, shares at Dec. 31, 2020 | 0 | |||||
Convertible preferred shares, ending balance, shares at Sep. 30, 2021 | 0 | |||||
Beginning balance, shares at Dec. 31, 2020 | 16,305,731 | |||||
Beginning balance at Dec. 31, 2020 | 72,799 | $ 16 | 267,077 | (119) | (194,175) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (58,489) | |||||
Ending balance, shares at Sep. 30, 2021 | 24,708,727 | |||||
Ending balance at Sep. 30, 2021 | 68,679 | $ 25 | 321,437 | (119) | (252,664) | |
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||
Redeemable Common Shares, Value | $ 1,875 | |||||
Redeemable common shares, beginning balance, shares at Mar. 31, 2021 | 229,885 | |||||
Convertible preferred shares, ending balance, shares at Jun. 30, 2021 | 229,885 | |||||
Beginning balance, shares at Mar. 31, 2021 | 23,426,429 | |||||
Beginning balance at Mar. 31, 2021 | 105,062 | $ 24 | 318,008 | (119) | (212,851) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock Issued During Period, Value, New Issues | $ 0 | |||||
Stock Issued During Period Shares Warrants Exercised | 1,056,881 | |||||
Stock Issued During Period Value Warrants Exercised | 1 | $ 1 | ||||
Issuance of shares under employee stock purchase plan, shares | 20,232 | |||||
Stock Issued During Period, Value, Employee Stock Purchase Plan | 116 | 116 | ||||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations, shares | 81,316 | |||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | 0 | |||||
Stock-based compensation expense | 1,797 | 1,797 | ||||
Net loss | (19,638) | |||||
Ending balance, shares at Jun. 30, 2021 | 24,584,858 | |||||
Ending balance at Jun. 30, 2021 | 87,338 | $ 25 | 319,921 | (119) | (232,489) | |
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||
Redeemable Common Shares, Value | $ 1,875 | |||||
Convertible preferred shares, ending balance, shares at Sep. 30, 2021 | 0 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Vesting of restricted stock units, less shares withheld and retired to satisfy tax obligations, shares | 123,869 | |||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | 0 | |||||
Stock-based compensation expense | $ 1,516 | 1,516 | ||||
Stock Repurchased and Retired During Period, Shares | (229,885) | |||||
Stock Repurchased and Retired During Period, Value | $ 0 | $ (1,875) | ||||
Net loss | (20,175) | (20,175) | ||||
Ending balance, shares at Sep. 30, 2021 | 24,708,727 | |||||
Ending balance at Sep. 30, 2021 | 68,679 | $ 25 | 321,437 | (119) | (252,664) | |
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||
Redeemable Common Shares, Value | $ 0 | |||||
Beginning balance, shares at Dec. 31, 2021 | 28,127,657 | |||||
Beginning balance at Dec. 31, 2021 | 64,412 | $ 28 | 347,374 | (119) | (282,871) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock Issued During Period, Shares, New Issues | 2,512,902 | |||||
Stock Issued During Period, Value, New Issues | 5,820 | $ 3 | 5,817 | |||
Restricted Stock, Shares Issued Net of Shares for Tax Withholdings | 168,817 | |||||
Restricted Stock, Value, Shares Issued Net of Tax Withholdings | (12) | (12) | ||||
Stock Issued During Period Shares Warrants Exercised | 100 | |||||
Stock-based compensation expense | 1,459 | 1,459 | ||||
Net loss | (21,965) | (21,965) | ||||
Ending balance, shares at Mar. 31, 2022 | 30,809,476 | |||||
Ending balance at Mar. 31, 2022 | 49,714 | $ 31 | 354,638 | (119) | (304,836) | |
Beginning balance, shares at Dec. 31, 2021 | 28,127,657 | |||||
Beginning balance at Dec. 31, 2021 | 64,412 | $ 28 | 347,374 | (119) | (282,871) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Reclassification of warrant liability to permanent equity | 38,754 | |||||
Net loss | (64,763) | |||||
Ending balance, shares at Sep. 30, 2022 | 68,734,553 | |||||
Ending balance at Sep. 30, 2022 | 61,849 | $ 69 | 409,533 | (119) | (347,634) | |
Beginning balance, shares at Mar. 31, 2022 | 30,809,476 | |||||
Beginning balance at Mar. 31, 2022 | 49,714 | $ 31 | 354,638 | (119) | (304,836) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock Issued During Period, Shares, New Issues | 72,727 | |||||
Stock Issued During Period, Value, New Issues | 49 | 49 | ||||
Restricted Stock, Shares Issued Net of Shares for Tax Withholdings | 108,995 | |||||
Restricted Stock, Value, Shares Issued Net of Tax Withholdings | 0 | 0 | ||||
Stock-based compensation expense | 1,522 | 1,522 | ||||
Net loss | (21,212) | (21,212) | ||||
Ending balance, shares at Jun. 30, 2022 | 30,991,198 | |||||
Ending balance at Jun. 30, 2022 | 30,073 | $ 31 | 356,209 | (119) | (326,048) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock Issued During Period, Shares, New Issues | 37,649,086 | |||||
Stock Issued During Period, Value, New Issues | 13,497 | $ 38 | 13,459 | |||
Restricted Stock, Shares Issued Net of Shares for Tax Withholdings | 94,269 | |||||
Restricted Stock, Value, Shares Issued Net of Tax Withholdings | 0 | |||||
Reclassification of warrant liability to permanent equity | 38,754 | 38,754 | ||||
Stock-based compensation expense | 1,111 | 1,111 | ||||
Net loss | (21,586) | (21,586) | ||||
Ending balance, shares at Sep. 30, 2022 | 68,734,553 | |||||
Ending balance at Sep. 30, 2022 | $ 61,849 | $ 69 | $ 409,533 | $ (119) | $ (347,634) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (64,763) | $ (58,489) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 4,092 | 4,571 |
Depreciation and amortization expense | 389 | 367 |
Non-cash lease expense | 1,104 | 1,031 |
Accretion of debt discount | 653 | 557 |
Other | 255 | 283 |
Changes in operating assets and liabilities: | ||
Prepaid expenses, other current assets and research and development incentive receivable | 158 | (14) |
Accounts payable | (481) | (695) |
Accrued expenses | 1,305 | 1,069 |
Lease liabilities | (721) | (473) |
Operating lease right-of-use asset, net of non-cash portion | 0 | 59 |
Net cash used in operating activities | (58,009) | (51,852) |
Cash flows from investing activities: | ||
Acquisition of property, equipment and intangible assets | (69) | (602) |
Net cash used in investing activities | (69) | (602) |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options and pre-funded warrants and issuance of shares of common stock under employee stock purchase plan | 70 | 157 |
Employee taxes paid related to net share settlement of vested restricted stock units | (12) | 0 |
Issuance costs related to sale of warrants and fees paid for amendments to loan and security agreement | (3,300) | 0 |
Repayments of Secured Debt | (795) | 0 |
Proceeds from sale of shares of common stock, redeemable common stock, warrants and pre-funded warrants, net of issuance costs | 60,623 | 51,518 |
Settlement and retirement of redeemable common stock | 0 | (2,000) |
Net cash provided by financing activities | 56,586 | 49,675 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (468) | (203) |
Net decrease in cash, cash equivalents and restricted cash | (1,960) | (2,982) |
Cash, cash equivalents and restricted cash at beginning of period | 83,108 | 80,702 |
Cash, cash equivalents and restricted cash at end of period | 81,148 | 77,720 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Acquisition of right-of-use asset financed by lease liabilities | 0 | 1,343 |
Issuance costs not yet paid related to sale of shares of common stock, redeemable common stock and pre-funded warrants | $ 22 | $ 0 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK, REDEEMABLE COMMON STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) $ in Thousands | 3 Months Ended |
Jun. 30, 2022 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Issuance costs | |
Stock Issued During Period, Value, New Issues | $ 49 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Basis of Presentation | NATURE OF THE BUSINESS AND BASIS OF PRESENTATION X4 Pharmaceuticals, Inc. (together with its subsidiaries, the “Company”) is a late-stage clinical biopharmaceutical company focused on the research, development and commercialization of novel therapeutics for the treatment of diseases of the immune system, with a focus on rare diseases and those with limited treatment options. The Company’s lead product candidate, mavorixafor, a first-in-class, small molecule antagonist of chemokine receptor CXCR4 being developed as a once-daily oral therapy, is currently being evaluated in a Phase 3 clinical trial for the treatment of Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (“WHIM”) syndrome, a rare, inherited, primary immunodeficiency disease typically caused by genetic mutations in the CXCR4 receptor gene. The Company continues to expect to report results from this trial in the fourth quarter of 2022. The Company is also conducting a proof-of-concept Phase 1b clinical trial of mavorixafor in patients with chronic neutropenic disorders, and a Phase 1b clinical trial of mavorixafor in combination with ibrutinib in patients with Waldenström’s macroglobulinemia (“Waldenström’s”), a rare form of lymphoma. The Company reported positive results from these Phase 1b trials in the third quarter of 2022. The Phase 1b clinical trial in chronic neutropenic disorders is currently being amended to extend and expand the trial. The Phase 1b clinical trial in Waldenström’s is expected to conclude in December 2022; further studies of mavorixafor in this and other oncology indications will be subject to completing a strategic partnership. The Company is headquartered in Boston, Massachusetts and has a research facility in Vienna, Austria. Going Concern Assessment— 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 these condensed consolidated financial statements are issued. As of September 30, 2022, the Company had $79.9 million of cash and cash equivalents. Based on its current operating plan, the Company believes that its cash on hand will be sufficient to fund its operating expense and capital expenditure requirements into the third quarter of 2023. However, as further discussed in Note 7, the Company has a covenant under its loan agreement with Hercules Capital Inc. (“Hercules”) that requires that the Company maintain a minimum level of cash, as defined. Based on its current financial projections and assuming the Company does not meet certain operational and financial milestones that would reduce the minimum cash required by this covenant, the Company believes it would be in violation of the covenant in the second quarter of 2023. If the Company is in violation of this covenant, Hercules could require the repayment of all of the Company’s outstanding debt under the Hercules loan facility. As a result, the Company believes that, in the aggregate, these conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. Nevertheless, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. In order to fund its operations beyond the second quarter of 2023, the Company will need to raise additional funding, whether 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 future funding when and if needed, the Company may be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or pre-commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. There is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. Impact of the COVID-19 Pandemic— Beginning in late 2019 and continuing into 2022, the outbreak of COVID-19 has resulted in the declaration of a global pandemic and adversely affected economic activity across virtually all sectors and industries on a local, national and global scale. Impacts to the Company’s business have included temporary closures or postponements of activation of its clinical trial sites or facilities, disruptions or restrictions on its employees’ ability to travel, disruptions to or delays in ongoing clinical trials, including patient enrollment at a slower pace than initially projected and the diversion of healthcare resources away from the conduct of the Company’s clinical trials as a result of the ongoing COVID-19 pandemic, including the diversion of hospitals serving as the Company’s clinical trial sites and hospital staff supporting the conduct of the Company’s clinical trials. While global vaccination efforts are underway and certain jurisdictions, including Massachusetts, where the Company is headquartered, have reopened businesses and governmental agencies, there remain limitations on the physical operations of businesses and prohibitions on certain non-essential gatherings, and the Company is unable to accurately predict the full impact that the COVID-19 pandemic will have due to numerous uncertainties, including the duration of the outbreak, the result of vaccination efforts, resurgence of the virus, actions that may be taken by governmental authorities, the impact on the Company’s business including its clinical programs and timelines, and the impact to the business of its service providers and partners. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Significant Accounting Policies— The Company’s significant accounting policies are disclosed in the audited consolidated financial statements and the notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022 (the “2021 Annual Report”). Since the date of those consolidated financial statements, there have been no material changes to the Company’s significant accounting policies. Risks and Uncertainties— The impact of the ongoing COVID-19 pandemic has been and, notwithstanding vaccination efforts, is expected to continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. Impacts to the Company’s business have included temporary closures or postponements of activation of its clinical trial sites or facilities, disruptions or restrictions on its employees’ ability to travel, disruptions to or delays in ongoing clinical trials, including patient enrollment at a slower pace than initially projected and the diversion of healthcare resources away from the conduct of the Company’s clinical trials as a result of the ongoing COVID-19 pandemic, including the diversion of hospitals serving as the Company’s clinical trial sites and hospital staff supporting the conduct of the Company’s clinical trials. In addition, the Company is subject to other challenges and risks specific to its business and its ability to execute on its business plan and strategy, as well as risks and uncertainties common to companies in the biotechnology industry with research and development operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its product candidates; delays or problems in obtaining clinical supply, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing its intellectual property rights; and the challenges of complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it is expected also to have the effect of heightening many of the other risks and uncertainties discussed above. Principles of Consolidation— The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, including X4 Pharmaceuticals (Austria) GmbH, which is incorporated in Vienna, Austria (“X4 Austria”), and X4 Therapeutics, Inc. All significant intercompany accounts and transactions have been eliminated. Unaudited Interim Condensed Consolidated Financial Statements— The condensed consolidated balance sheet at December 31, 2021 that is presented in these interim condensed consolidated financial statements was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). The accompanying condensed consolidated financial statements are unaudited. The accompanying unaudited interim condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial statements. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2021 included in the 2021 Annual Report. In the opinion of management, all adjustments, consisting only of normal recurring adjustments as necessary, for the fair statement of the Company’s condensed financial position, condensed results of its operations and cash flows have been made. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022. Use of Estimates— The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these condensed 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. The COVID-19 pandemic has impacted and is expected to continue to impact the clinical development timelines for certain of the Company's clinical programs. As of the date of issuance of these condensed 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 condensed consolidated financial statements. 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 September 30, 2022 and December 31, 2021. Restricted Cash (in thousands) As of September 30, 2022 As of December 31, 2021 Letter of credit security: Waltham lease 250 250 Letter of credit security: Vienna Austria lease 187 216 Letter of credit security: Boston lease 856 855 Restricted cash included in other assets $ 1,293 $ 1,321 In connection with the Company’s lease agreements 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. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets to the sum of the total of amounts shown in the Company’s condensed consolidated statements of cash flows as of September 30, 2022 and December 31, 2021: (in thousands) September 30, 2022 December 31, 2021 Cash and cash equivalents $ 79,855 $ 81,787 Restricted cash, non-current 1,293 1,321 Total cash, cash equivalents and restricted cash $ 81,148 $ 83,108 Goodwill— Goodwill is tested 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 or unanticipated competition. The Company has determined that it operates in a single operating segment and has a single reporting unit. The Company assesses qualitative factors to determine whether the existence of events or circumstances would indicate that it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If after assessing the totality of events or circumstances, the Company were to determine that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, then the Company would perform an interim quantitative impairment test, whereby 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 its 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 . There were no triggering events during the nine months ended September 30, 2022 that necessitated an interim impairment test of goodwill. Recently Adopted Accounting Standards In May 2021, the Financial Accounting Standards Board (“FASB”) issued ASU 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. ASU 2021-04 was issued to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants for the purchase of common shares) that remain classified as equity following the modification or exchange. ASU 2021-04 was effective January 1, 2022 for the Company. The adoption of this standard did not have an impact on the Company’s consolidated financial statements. Recently Issued Accounting Standards Not Yet Adopted 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, |
License, Collaboration, and Fun
License, Collaboration, and Funding Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License, Collaboration, and Funding Agreements | LICENSE, COLLABORATION AND FUNDING AGREEMENTS 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 and capital expenditures incurred by the Company’s subsidiary in Austria. As of September 30, 2022, the amount due under the program is $0.9 million, which amount is included in research and development incentive receivable in the condensed consolidated balance sheet. During the nine months ended September 30, 2022 and 2021, the Company recorded $0.4 million and $0.7 million, respectively, of income related to the program within the condensed consolidated statements of operations as other income. License and Collaboration Agreements During the nine months ended September 30, 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 nine months ended September 30, 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 nine months ended September 30, 2022. There were no material modifications of the Company’s license or collaboration agreements during the nine months ended September 30, 2022. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 9 Months Ended |
Sep. 30, 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 September 30, 2022 Using: (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents—money market funds $ — $ 2,516 $ — $ 2,516 $ — $ 2,516 $ — $ 2,516 Liabilities: Embedded derivative liability $ — $ — $ 310 $ 310 $ — $ — $ 310 $ 310 Fair Value Measurements as of December 31, 2021 Using: (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents—money market funds $ 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 assets, which represents a Level 1 measurement, or by using inputs observable in active markets for similar securities, which represents a Level 2 measurement. The following table provides a roll-forward of the aggregate fair values financial instruments for which fair values are determined using Level 3 inputs: (in thousands) Embedded Derivative Liability Warrant Liability Total Balance as of December 31, 2021 $ 821 $ — $ 821 Issuance of warrants (see Note 10) — 41,249 41,249 Change in fair value (511) (2,495) (3,006) Reclassification of warrant liability to permanent equity — (38,754) (38,754) Balance as of September 30, 2022 $ 310 $ — $ 310 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 condensed consolidated balance sheets, is estimated by the Company at each reporting date based, in part, on the results of third party valuations, which are prepared based on a discounted cash flow model that considers 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%. Warrant Liability — As discussed in Note 10, on July 6, 2022, the Company issued common stock, pre-funded warrants and warrants for the purchase of its common stock in a private placement transaction. The warrants have an exercise price of $1.095 per share and expire five years from the original issuance date. 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 a portion of the offering proceeds to a warrant liability at its fair value. The fair value was calculated using the Black-Scholes option valuation model using significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. These assumptions are shown in the table below. On September 1, 2022, the Company’s shareholders approved an increase in the Company’s authorized shares. 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 warrants through earnings, including within other expense, net, and reclassified the fair value of the liability to additional paid-in capital. July 6, 2022 September 1, 2022 Risk-free interest rate 2.96 % 3.29 % Expected term (in years) 5.0 years 4.9 years Expected volatility 97.3 % 97.5 % Expected dividend yield — % — % Fair value of warrant liability $ 41,249 $ 38,754 |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following: (in thousands) September 30, 2022 December 31, 2021 Leasehold improvements $ 228 $ 228 Furniture and fixtures 1,268 1,251 Computer equipment 173 150 Software 24 33 Lab equipment 605 576 2,298 2,238 Less: Accumulated depreciation and amortization (1,104) (724) $ 1,194 $ 1,514 Depreciation and amortization expense related to property and equipment was $389 thousand and $367 thousand for the nine months ended September 30, 2022 and 2021, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | ACCRUED EXPENSES Accrued expenses consisted of the following: (in thousands) September 30, December 31, Accrued employee compensation and benefits $ 4,388 5,417 Accrued external research and development expenses 3,611 1,507 Accrued professional fees 779 632 Accrued issuance costs for private placement equity offering (Note 10) 22 — Other 328 314 $ 9,128 $ 7,870 |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-term debt consisted of the following: (in thousands) September 30, December 31, Principal amount of long-term debt $ 32,500 $ 32,500 Debt (discount) premium, net of accretion (221) 277 Cumulative accretion of end of term payments 1,075 1,157 Long-term debt $ 33,354 $ 33,934 Less: current portion $ (14,621) $ (795) Long-term debt, net of current portion $ 18,733 $ 33,139 Hercules Loan Agreement, As Amended In October 2018, the Company entered into a Loan and Security Agreement (the “Hercules Loan Agreement”), as amended in December 2018, June 2019, March 2020, December 2020, February 2022 and June 2022, with Hercules, under which the Company has borrowed an aggregate of $32.5 million of term loans to date. The Hercules Loan Agreement provides for maximum borrowings of up to $50.0 million, which include, 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 accrues 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%. Borrowings under the Hercules Loan Agreement are repayable in monthly interest-only payments through January 1, 2023, and in equal monthly payments of principal and accrued interest from February 1, 2023 until the maturity date of the loan, which is July 1, 2024. The Company may prepay all, but not less than all, of the outstanding borrowings, subject to a prepayment premium of up to 1.0% of the principal amount outstanding as of the date of repayment. In addition, the Hercules Loan Agreement provides for payments of $1.3 million and $0.8 million payable on July 1, 2023 and July 1, 2024, respectively, which payments are accelerated upon the prepayment of the borrowings upon the Company’s election or upon default of the loan. Borrowings under the Hercules 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 and proceeds from the sale, licensing or disposition of the intellectual property). On February 9, 2022, the Company entered into Amendment No. 3 of the Hercules Loan Agreement (“Amendment 3”). Amendment 3 primarily added a financial milestone that if met by June 30, 2022, modifies the minimum cash covenant contained in the Hercules Loan Agreement effective beginning September 1, 2022, as further described below. The Company achieved this financial milestone. The Company concluded that Amendment 3 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. On June 30, 2022, the Company entered into Amendment No. 4 of the Hercules Loan Agreement (“Amendment 4”). Amendment 4 primarily added two additional milestones that if met will extend the interest-only period of the debt under the Hercules facility. To achieve the first interest-only extension milestone, which would extend the interest-only period from February 1, 2023 to August 1, 2023, the Company must raise $50.0 million in external financing and achieve Performance Milestone III, as defined in the Hercules Loan Agreement. Performance Milestone III includes, assuming no other events of default, (a) the Company’s Phase 3 trial for the treatment of WHIM having achieved its protocol-specified primary efficacy endpoint with statistical significance, an acceptable safety profile, and supporting efficacy data, such that the totality of safety and efficacy data are sufficient to file a New Drug Application (“NDA”) as the immediate next step in clinical development and (b) the Company has proceeded towards filing such NDA. The Company has achieved the external financing portion of this milestone effective June 30, 2022 and has not yet achieved Performance Milestone III. To achieve the second interest-only extension milestone, which would further extend the interest-only period of the debt to February 1, 2024, the Company must raise an additional $25.0 million in external financing and file an NDA for mavorixafor for the treatment of WHIM syndrome. The Company has concluded that Amendment 4 represents a modification to the debt as opposed to a debt 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 must 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 achievement of Performance Milestone III, as defined in the Hercules Loan Agreement, the required level shall be 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 will be extinguished. The Hercules Loan Agreement also 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. The Company recognized interest expense under the Hercules Loan Agreement as follows: (in thousands) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Total interest expense $ 1,018 $ 920 $ 2,845 $ 2,716 Non-cash interest expense $ 256 $ 193 $ 653 $ 557 The annual effective interest rate of the Hercules Loan Agreement as of September 30, 2022 is 12.9%. There were no principal payments due or paid under the Hercules Loan Agreement during the nine months ended September 30, 2022. An end-of-term payment of $0.8 million was paid during the nine months ended September 30, 2022 in accordance with the Hercules Loan Agreement. As of September 30, 2022, future principal and accrued end-of-term payments due under the Hercules Loan Agreement were as follows (in thousands): Year Ending December 31, Total 2022 $ — 2023 20,050 2024 13,525 Long-term debt $ 33,575 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | LEASES The Company has lease agreements for its facilities in Boston, Massachusetts, which is the Company’s principal executive office; Vienna, Austria, which is the Company’s research and development center; and Waltham, Massachusetts, which the Company has sublet to a third party. There are no restrictions or financial covenants associated with any of the lease agreements. • 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 7 years. The annual base rent for the Vienna Lease is approximately $300 thousand. • 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-year term of the lease. 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 and amount equal to the lease payments in a similar economic environment. The components of lease expense for the three and nine months ended September 30, 2022 and 2021 were as follows: (dollars in thousands) Three Months Ended September 30, Nine Months Ended September 30, Lease Cost 2022 2021 2022 2021 Fixed operating lease cost $ 507 $ 537 $ 1,561 $ 1,554 Short-term lease costs — — — 42 Total lease expense $ 507 $ 537 $ 1,561 $ 1,596 Other information Right-of-use asset obtained in exchange for operating lease liabilities $ — $ — $ — $ 1,343 Operating cash flows from operating leases $ 334 $ 314 $ 1,014 $ 917 Sublease income $ 49 $ 49 $ 147 $ 147 Weighted-average remaining lease term—operating leases 4.2 years Weighted-average discount rate—operating leases 11.3 % Maturities of lease liabilities due under lease agreements that have commenced as of September 30, 2022 are as follows (in thousands) Maturity of lease liabilities Operating 2022 (remainder of the year) $ 391 2023 1,585 2024 1,350 2025 1,378 2026 1,308 Thereafter 299 Total lease payments 6,311 Less: interest (1,348) Total operating lease liabilities as of September 30, 2022 $ 4,963 |
Commitment and Contingencies
Commitment and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitment and Contingencies | COMMITMENTS AND CONTINGENCIES The Company has agreements with Contract 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. 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 condensed consolidated financial statements as of September 30, 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 any legal proceedings. |
Common Stock Warrants
Common Stock Warrants | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Common Stock Warrants | COMMON STOCK AND COMMON STOCK WARRANTS As of December 31, 2021, the Company’s Restated Certificate of Incorporation authorized the Company to issue 125 million shares of common stock, par value $0.001 per share. On September 1, 2022, the Company’s shareholders approved an increase in the Company’s authorized shares to 500 million. 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 any preferred stock that may be issued. 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. Q2 2022 Private Placement On June 30, 2022, the Company entered into a securities purchase agreement with several institutional and accredited investors (the “Investors”) pursuant to which the Company agreed to issue to the Investors 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 (the “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. 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. The Company received gross proceeds of $55.7 million, before deducting offering expenses paid by the Company. Each Warrant has an exercise price equal to $1.095 per share. The Warrants will expire on the date that is 60 months from their original issue date. The exercise of any Warrant was conditioned upon the Company increasing its authorized shares. 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 expense, net, 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 (the “Registration Rights Agreement”) with the Investors, 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 held by the Investors. Such registration statement was filed on July 29, 2022 and was declared effective by the SEC on August 5, 2022. Q1 2022 Private Placement On March 3, 2022, the Company entered into a securities purchase agreement pursuant to which it agreed to issue and sell to an investor (the “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. Also, on March 3, 2022, the Company entered into a registration rights agreement with the Investor, pursuant to which the Company filed a registration statement covering the resale of these securities in April 2022. Class B Warrants In connection with its issuance of common stock in a public offering 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 pre-funded 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 and expire on a date that is the earlier of (a) the date that is 30 calendar days from the date on which the Company issues a press release announcing top-line data from its Phase 3 clinical trial of mavorixafor for the treatment of patients with WHIM syndrome (or, if such date is not a business day, the next business day) and (b) November 28, 2024. The Class B warrants have a contingent price adjustment feature pursuant to which the exercise price of the Class B warrants is adjusted to the lowest weighted average offering price at which the Company sells its common stock or certain securities convertible into or exercisable for the Company's common stock in one or more subsequent offerings, if the weighted average offering price for such offering is below $15.00. The exercise price of the Class B warrants was adjusted to $1.80 on March 3, 2022 as a result of the Q1 2022 PIPE and was further adjusted to $1.50 on July 6, 2022 as a result of the Q2 2022 PIPE. Prefunded Warrants In connection with previous equity offerings, the Company has issued pre-funded warrants, which are exercisable into one share of the Company's common stock, are immediately exercisable upon issuance, and for which the remaining exercise price is equal to or less than $0.01 per share. The following table provides a roll forward of outstanding warrants for the nine month period ended September 30, 2022: Number of warrants Weighted Average Exercise Price Weighted Average Contractual Term (Years) Outstanding and exercisable warrants to purchase common shares as of December 31, 2021 13,257,160 $7.96 2.72 Issued 64,968,310 $1.10 Exercised (100) Outstanding and exercisable warrants to purchase common shares as of September 30, 2022 78,225,370 $2.12 4.32 As of September 30, 2022, the Company’s outstanding warrants to purchase shares of common stock consisted of the following: Issuance Date Number of Exercise 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 5,416,567 $ 1.50 November 28, 2024 November 29, 2019 1,750,000 $ 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 $ 1.094 (e) n/a July 6, 2022 50,925,365 $ 1.095 July 6, 2027 78,225,370 (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 $1.4 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.01 per pre-funded warrant. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION Summary of Plans— The Company has the following equity incentive plans: • The X4 Pharmaceuticals Inc. 2015 Employee, Director and Consultant Equity Incentive Plan, as amended (the “2015 Plan”); • The X4 Pharmaceuticals Inc. 2017 Equity Incentive Plan (the “2017 Plan”); and • The X4 Pharmaceuticals Inc. 2019 Inducement Equity Incentive Plan (the “2019 Plan”) The Company also has the following employee stock purchase plan: • The X4 Pharmaceutical Inc. 2017 Employee Stock Purchase Plan (the “2017 ESPP”) These plans are administered by the Board of Directors or by a committee of the Board of Directors. 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 or four years. Shares that are expired, terminated, surrendered or canceled under the Plans without having been fully exercised will be available for future awards. 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 the grant of awards. As of September 30, 2022, there are an aggregate of approximately 1.2 million shares of common stock available for issuance under the Company’s equity incentive plans. Approximately 196,000 shares of common stock remain available for issuance under the 2017 ESPP. 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 to employees, directors and non-employees. Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Risk-free interest rate 3.3 % 1.1 % 2.4 % 1.0 % Expected term (in years) 6.1 6.1 6.1 6.0 Expected volatility 95.7 % 95.7 % 94.8 % 97.6 % Expected dividend yield 0 % 0 % 0 % 0 % Stock Options The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2022: Number of Weighted Weighted Aggregate Outstanding as of December 31, 2021 1,916,051 $ 10.01 7.8 $ — Granted 339,950 1.60 Forfeited and Expired (412,328) 11.59 Outstanding as of September 30, 2022 1,843,673 $ 8.11 6.5 $ 73 Exercisable as of September 30, 2022 1,119,308 $ 10.12 6.5 $ — Vested and expected to vest as of September 30, 2022 1,670,385 $ 8.52 7.2 $ 46 There were no stock options exercised in the nine months ended September 30, 2022. The aggregate intrinsic value of stock options exercised during the nine months ended September 30, 2021 was $13 thousand. The weighted average grant-date fair value per share of stock options granted during the nine months ended September 30, 2022 and 2021 was $1.24 and $5.39, respectively. Restricted Stock Units— The following table summarizes the Company's restricted stock unit activity for the nine months ended September 30, 2022: Number of Unvested as of December 31, 2021 925,101 Granted 1,289,425 Vested (384,814) Forfeited (431,923) Unvested as of September 30, 2022 1,397,789 During the nine months ended September 30, 2022, the Company granted time-based restricted stock units to employees and to members of the Board of Directors. These restricted stock units vest annually over a two or three year period. Stock-based compensation expense is being recognized for these time-based awards ratably based on the intrinsic value of the awards as of the date of grant, less estimated forfeitures. Stock-Based Compensation— As of September 30, 2022, total unrecognized compensation expense related to unvested stock options and restricted stock units was $5.0 million, which is expected to be recognized over a weighted average period of 1.7 years. Stock-based compensation expense was classified in the condensed consolidated statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Research and development expense $ 576 $ 633 $ 1,990 $ 2,008 Selling, general and administrative expense 535 883 2,102 2,563 Total stock-based compensation $ 1,111 $ 1,516 4,092 4,571 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXESThe Company did not record a U.S. federal or state income tax benefit for its losses for the three and nine months ended September 30, 2022 and 2021, due to the conclusion that a full valuation allowance is required against the Company’s U.S. federal and state deferred tax assets. For the three and nine months ended September 30, 2022 and September 30, 2021, the Company recorded an immaterial income tax provision related to its Austrian subsidiary. |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 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: Three Months Ended September 30, Nine Months Ended September 30, (in thousands, except per share data) 2022 2021 2022 2021 Numerator: Net loss $ (21,586) $ (20,175) $ (64,763) $ (58,489) Deemed dividend as a result of Class B warrant price reset (Note 10) (287) — (2,546) (8,239) Net loss attributable to common stockholders $ (21,873) $ (20,175) $ (67,309) $ (66,728) Denominator: Weighted average shares of common stock outstanding—basic and diluted 83,211 26,609 50,976 24,667 Net loss per share attributable to common stockholders— basic and diluted $ (0.26) $ (0.76) $ (1.32) $ (2.71) Basic and diluted weighted average shares of common stock outstanding for the three and nine months ended September 30, 2022 and September 30, 2021 include the weighted average effect of outstanding pre-funded warrants for the purchase of shares of common stock for which the remaining unfunded exercise price is $0.01 or less per share. During the nine months ended September 30, 2022 and September 30, 2021, in accordance with the Class B Warrant agreement, the exercise price of each outstanding Class B Warrant was adjusted to the price of shares of the Company’s common stock sold in public or private offerings to the extent such price is lower than the previous Class B warrant price. These price 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 include outstanding stock options, unvested restricted stock units and warrants to purchase shares of common stock for the three and nine months ended September 30, 2022 and 2021. All 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 shares of common stock 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, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Options to purchase shares of common stock 1,843,673 1,952,891 1,843,673 1,952,891 Unvested restricted stock units 1,397,789 906,873 1,397,789 906,873 Warrants to purchase shares of common stock (excluding prefunded warrants, which are included in basic shares outstanding) 60,374,393 9,449,128 60,374,393 9,449,128 63,615,855 12,308,892 63,615,855 12,308,892 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation— The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, including X4 Pharmaceuticals (Austria) GmbH, which is incorporated in Vienna, Austria (“X4 Austria”), and X4 Therapeutics, Inc. All significant intercompany accounts and transactions have been eliminated. |
Unaudited Interim Financial Statements | Unaudited Interim Condensed Consolidated Financial Statements— The condensed consolidated balance sheet at December 31, 2021 that is presented in these interim condensed consolidated financial statements was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). The accompanying condensed consolidated financial statements are unaudited. The accompanying unaudited interim condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial statements. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2021 included in the 2021 Annual Report. In the opinion of management, all adjustments, consisting only of normal recurring adjustments as necessary, for the fair statement of the Company’s condensed financial position, condensed results of its operations and cash flows have been made. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022. |
Use of Estimates | Use of Estimates— The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these condensed 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. The COVID-19 pandemic has impacted and is expected to continue to impact the clinical development timelines for certain of the Company's clinical programs. As of the date of issuance of these condensed 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 condensed consolidated financial statements. |
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 September 30, 2022 and December 31, 2021. |
Goodwill | Goodwill— Goodwill is tested 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 or unanticipated competition. The Company has determined that it operates in a single operating segment and has a single reporting unit. The Company assesses qualitative factors to determine whether the existence of events or circumstances would indicate that it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If after assessing the totality of events or circumstances, the Company were to determine that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, then the Company would perform an interim quantitative impairment test, whereby 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 its 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 . There were no triggering events during the nine months ended September 30, 2022 that necessitated an interim impairment test of goodwill. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Standards In May 2021, the Financial Accounting Standards Board (“FASB”) issued ASU 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. ASU 2021-04 was issued to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants for the purchase of common shares) that remain classified as equity following the modification or exchange. ASU 2021-04 was effective January 1, 2022 for the Company. The adoption of this standard did not have an impact on the Company’s consolidated financial statements. Recently Issued Accounting Standards Not Yet Adopted 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, |
Research and Development Expense, Policy |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Restricted Cash | Restricted Cash (in thousands) As of September 30, 2022 As of December 31, 2021 Letter of credit security: Waltham lease 250 250 Letter of credit security: Vienna Austria lease 187 216 Letter of credit security: Boston lease 856 855 Restricted cash included in other assets $ 1,293 $ 1,321 |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets to the sum of the total of amounts shown in the Company’s condensed consolidated statements of cash flows as of September 30, 2022 and December 31, 2021: (in thousands) September 30, 2022 December 31, 2021 Cash and cash equivalents $ 79,855 $ 81,787 Restricted cash, non-current 1,293 1,321 Total cash, cash equivalents and restricted cash $ 81,148 $ 83,108 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | ||
Schedule of Assets and Liabilities Measured at Fair Value | 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 September 30, 2022 Using: (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents—money market funds $ — $ 2,516 $ — $ 2,516 $ — $ 2,516 $ — $ 2,516 Liabilities: Embedded derivative liability $ — $ — $ 310 $ 310 $ — $ — $ 310 $ 310 Fair Value Measurements as of December 31, 2021 Using: (in thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents—money market funds $ 20,000 $ 27,793 $ — $ 47,793 $ 20,000 $ 27,793 $ — $ 47,793 Liabilities: Embedded derivative liability $ — $ — $ 821 $ 821 $ — $ — $ 821 $ 821 | |
Summary of Aggregate Fair Values of Warrant Liability and Derivative Liability | The following table provides a roll-forward of the aggregate fair values financial instruments for which fair values are determined using Level 3 inputs: (in thousands) Embedded Derivative Liability Warrant Liability Total Balance as of December 31, 2021 $ 821 $ — $ 821 Issuance of warrants (see Note 10) — 41,249 41,249 Change in fair value (511) (2,495) (3,006) Reclassification of warrant liability to permanent equity — (38,754) (38,754) Balance as of September 30, 2022 $ 310 $ — $ 310 | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | July 6, 2022 September 1, 2022 Risk-free interest rate 2.96 % 3.29 % Expected term (in years) 5.0 years 4.9 years Expected volatility 97.3 % 97.5 % Expected dividend yield — % — % Fair value of warrant liability $ 41,249 $ 38,754 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consisted of the following: (in thousands) September 30, 2022 December 31, 2021 Leasehold improvements $ 228 $ 228 Furniture and fixtures 1,268 1,251 Computer equipment 173 150 Software 24 33 Lab equipment 605 576 2,298 2,238 Less: Accumulated depreciation and amortization (1,104) (724) $ 1,194 $ 1,514 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: (in thousands) September 30, December 31, Accrued employee compensation and benefits $ 4,388 5,417 Accrued external research and development expenses 3,611 1,507 Accrued professional fees 779 632 Accrued issuance costs for private placement equity offering (Note 10) 22 — Other 328 314 $ 9,128 $ 7,870 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Long Term Debt | Long-term debt consisted of the following: (in thousands) September 30, December 31, Principal amount of long-term debt $ 32,500 $ 32,500 Debt (discount) premium, net of accretion (221) 277 Cumulative accretion of end of term payments 1,075 1,157 Long-term debt $ 33,354 $ 33,934 Less: current portion $ (14,621) $ (795) Long-term debt, net of current portion $ 18,733 $ 33,139 |
Interest Income and Interest Expense Disclosure | The Company recognized interest expense under the Hercules Loan Agreement as follows: (in thousands) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Total interest expense $ 1,018 $ 920 $ 2,845 $ 2,716 Non-cash interest expense $ 256 $ 193 $ 653 $ 557 |
Schedule of Future Principal Payments and the Final Payments Due | As of September 30, 2022, future principal and accrued end-of-term payments due under the Hercules Loan Agreement were as follows (in thousands): Year Ending December 31, Total 2022 $ — 2023 20,050 2024 13,525 Long-term debt $ 33,575 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense for the three and nine months ended September 30, 2022 and 2021 were as follows: (dollars in thousands) Three Months Ended September 30, Nine Months Ended September 30, Lease Cost 2022 2021 2022 2021 Fixed operating lease cost $ 507 $ 537 $ 1,561 $ 1,554 Short-term lease costs — — — 42 Total lease expense $ 507 $ 537 $ 1,561 $ 1,596 Other information Right-of-use asset obtained in exchange for operating lease liabilities $ — $ — $ — $ 1,343 Operating cash flows from operating leases $ 334 $ 314 $ 1,014 $ 917 Sublease income $ 49 $ 49 $ 147 $ 147 Weighted-average remaining lease term—operating leases 4.2 years Weighted-average discount rate—operating leases 11.3 % |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities due under lease agreements that have commenced as of September 30, 2022 are as follows (in thousands) Maturity of lease liabilities Operating 2022 (remainder of the year) $ 391 2023 1,585 2024 1,350 2025 1,378 2026 1,308 Thereafter 299 Total lease payments 6,311 Less: interest (1,348) Total operating lease liabilities as of September 30, 2022 $ 4,963 |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Schedule of Warrants | The following table provides a roll forward of outstanding warrants for the nine month period ended September 30, 2022: Number of warrants Weighted Average Exercise Price Weighted Average Contractual Term (Years) Outstanding and exercisable warrants to purchase common shares as of December 31, 2021 13,257,160 $7.96 2.72 Issued 64,968,310 $1.10 Exercised (100) Outstanding and exercisable warrants to purchase common shares as of September 30, 2022 78,225,370 $2.12 4.32 As of September 30, 2022, the Company’s outstanding warrants to purchase shares of common stock consisted of the following: Issuance Date Number of Exercise 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 5,416,567 $ 1.50 November 28, 2024 November 29, 2019 1,750,000 $ 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 $ 1.094 (e) n/a July 6, 2022 50,925,365 $ 1.095 July 6, 2027 78,225,370 (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 $1.4 million in aggregate proceeds. Each pre-funded warrant may be exercised for an additional $0.01 per pre-funded warrant. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 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 to employees, directors and non-employees. Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Risk-free interest rate 3.3 % 1.1 % 2.4 % 1.0 % Expected term (in years) 6.1 6.1 6.1 6.0 Expected volatility 95.7 % 95.7 % 94.8 % 97.6 % Expected dividend yield 0 % 0 % 0 % 0 % |
Summary of Stock Option Activity | The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2022: Number of Weighted Weighted Aggregate Outstanding as of December 31, 2021 1,916,051 $ 10.01 7.8 $ — Granted 339,950 1.60 Forfeited and Expired (412,328) 11.59 Outstanding as of September 30, 2022 1,843,673 $ 8.11 6.5 $ 73 Exercisable as of September 30, 2022 1,119,308 $ 10.12 6.5 $ — Vested and expected to vest as of September 30, 2022 1,670,385 $ 8.52 7.2 $ 46 |
Share-based Payment Arrangement, Restricted Stock and Restricted Stock Unit, Activity | Restricted Stock Units— The following table summarizes the Company's restricted stock unit activity for the nine months ended September 30, 2022: Number of Unvested as of December 31, 2021 925,101 Granted 1,289,425 Vested (384,814) Forfeited (431,923) Unvested as of September 30, 2022 1,397,789 |
Summary of Stock-Based Compensation Expense Classification | Stock-based compensation expense was classified in the condensed consolidated statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Research and development expense $ 576 $ 633 $ 1,990 $ 2,008 Selling, general and administrative expense 535 883 2,102 2,563 Total stock-based compensation $ 1,111 $ 1,516 4,092 4,571 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | Basic and diluted net loss per share attributable to common stockholders was calculated as follow: Three Months Ended September 30, Nine Months Ended September 30, (in thousands, except per share data) 2022 2021 2022 2021 Numerator: Net loss $ (21,586) $ (20,175) $ (64,763) $ (58,489) Deemed dividend as a result of Class B warrant price reset (Note 10) (287) — (2,546) (8,239) Net loss attributable to common stockholders $ (21,873) $ (20,175) $ (67,309) $ (66,728) Denominator: Weighted average shares of common stock outstanding—basic and diluted 83,211 26,609 50,976 24,667 Net loss per share attributable to common stockholders— basic and diluted $ (0.26) $ (0.76) $ (1.32) $ (2.71) |
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, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Options to purchase shares of common stock 1,843,673 1,952,891 1,843,673 1,952,891 Unvested restricted stock units 1,397,789 906,873 1,397,789 906,873 Warrants to purchase shares of common stock (excluding prefunded warrants, which are included in basic shares outstanding) 60,374,393 9,449,128 60,374,393 9,449,128 63,615,855 12,308,892 63,615,855 12,308,892 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Business Acquisition [Line Items] | ||
Cash and cash equivalents | $ 79,855 | $ 81,787 |
Accumulated deficit | $ (347,634) | $ (282,871) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Compensating Balance Arrangements (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents [Line Items] | ||
Total restricted cash | $ 1,293 | $ 1,321 |
Letter of Credit | Waltham Lease | ||
Cash and Cash Equivalents [Line Items] | ||
Restricted Cash | 250 | 250 |
Letter of Credit | Vienna Austria Lease | ||
Cash and Cash Equivalents [Line Items] | ||
Restricted Cash | 187 | 216 |
Letter of Credit | Allston Lease Agreement | ||
Cash and Cash Equivalents [Line Items] | ||
Restricted Cash | $ 856 | $ 855 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 79,855 | $ 81,787 | ||
Restricted cash, non-current | 1,293 | 1,321 | ||
Total cash, cash equivalents and restricted cash | $ 81,148 | $ 83,108 | $ 77,720 | $ 80,702 |
License, Collaboration, and F_2
License, Collaboration, and Funding Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Collaboration License And Funding Arrangements [Line Items] | ||||
Other (expense) income, net | $ (441) | $ (74) | $ (440) | $ 323 |
Gain (Loss) on Disposition of Other Assets | 500 | |||
Research and Development Incentive | ||||
Collaboration License And Funding Arrangements [Line Items] | ||||
Grant receivable | 900 | 900 | ||
Other (expense) income, net | $ 400 | $ 700 | $ 400 | $ 700 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities - Schedule of Assets and Liabilities Measured at Fair Value (Detail) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Measurements, Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | ||
Cash equivalents | $ 2,516,000 | $ 47,793,000 |
Fair value of derivative liability | 310,000 | 821,000 |
Fair Value, Measurements, Recurring | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | ||
Cash equivalents | 0 | 20,000,000 |
Fair value of derivative liability | 0 | 0 |
Fair Value, Measurements, Recurring | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | ||
Cash equivalents | 2,516,000 | 27,793,000 |
Fair value of derivative liability | 0 | 0 |
Fair Value, Measurements, Recurring | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Fair value of derivative liability | 310,000 | $ 821,000 |
Measurement Input, Discount Rate | ||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | ||
Fair value of derivative liability | $ 0.14 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Aggregate Fair Values Financial Instruments (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | $ 821 | |
Issuance of warrants (see Note 10) | 41,249 | |
Change in fair value | (3,006) | |
Reclassification of warrant liability to permanent equity | $ (38,754) | (38,754) |
Ending balance | 310 | 310 |
Embedded Derivative Liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 821 | |
Change in fair value | (511) | |
Ending balance | 310 | 310 |
Warrant Liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | |
Issuance of warrants (see Note 10) | 41,249 | |
Change in fair value | (2,495) | |
Reclassification of warrant liability to permanent equity | (38,754) | |
Ending balance | $ 0 | $ 0 |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities - Narrative (Details) - USD ($) | Sep. 30, 2022 | Jul. 06, 2022 |
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | ||
Warrant exercise price (usd per share) | $ 1.095 | |
Warrants and rights outstanding, term | 60 months | 5 years |
Measurement Input, Discount Rate | ||
Fair Value Assets And Liabilities Measured On Recurring Basis [Line Items] | ||
Fair value of derivative liability | $ 0.14 |
Fair Value of Financial Asset_6
Fair Value of Financial Assets and Liabilities - Fair Value Assumptions (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 01, 2022 | Jul. 06, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Risk-free interest rate (in percentage) | 3.30% | 1.10% | 2.40% | 1% | |||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years | |||
Expected volatility (in percentage) | 95.70% | 95.70% | 94.80% | 97.60% | |||
Expected dividend yield (in percentage) | 0% | 0% | 0% | 0% | |||
Fair value of warrant liability | $ 310 | $ 310 | $ 821 | ||||
Warrant Liability | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Risk-free interest rate (in percentage) | 3.29% | 2.96% | |||||
Expected term (in years) | 4 years 10 months 24 days | 5 years | |||||
Expected volatility (in percentage) | 97.50% | 97.30% | |||||
Expected dividend yield (in percentage) | 0% | 0% | |||||
Fair value of warrant liability | $ 38,754 | $ 41,249 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,298 | $ 2,238 |
Less: Accumulated depreciation and amortization | (1,104) | (724) |
Property and equipment, net | 1,194 | 1,514 |
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 | $ 605 | $ 576 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization expense | $ 389 | $ 367 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued employee compensation and benefits | $ 4,388 | $ 5,417 |
Accrued external research and development expenses | 3,611 | 1,507 |
Accrued professional fees | 779 | 632 |
Accrued issuance costs for private placement equity offering (Note 10) | 22 | 0 |
Other | 328 | 314 |
Total accrued expenses | $ 9,128 | $ 7,870 |
Long-Term Debt - Summary of Lon
Long-Term Debt - Summary of Long Term Debt (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Principal amount of long-term debt | $ 32,500 | $ 32,500 |
Debt (discount) premium, net of accretion | (221) | 277 |
Cumulative accretion of end of term payments | 1,075 | 1,157 |
Long-term debt | 33,354 | 33,934 |
Current portion of long-term debt | (14,621) | (795) |
Long-term debt, net of current portion | $ 18,733 | $ 33,139 |
Long Term Debt - Hercules Loan
Long Term Debt - Hercules Loan Agreement - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 30 Months Ended | ||||
Jul. 01, 2024 | Jul. 01, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Mar. 31, 2021 | |
Schedule Of Long Term Debt [Line Items] | |||||||
Principal payments | $ 800,000 | ||||||
Hercules Loan Agreement | |||||||
Schedule Of Long Term Debt [Line Items] | |||||||
Proceeds from lines of credit | $ 32,500,000 | ||||||
Line of credit facility, maximum borrowing capacity | $ 50,000,000 | $ 50,000,000 | |||||
Debt instrument variable percentage | 8.75% | ||||||
Interest rate increase percentage | 4% | ||||||
Contingent additional term loan advances, tranche three | $ 17,500,000 | 17,500,000 | |||||
Line of credit facility periodic payment | $ 1,300,000 | ||||||
Interest expense, debt | 1,018,000 | $ 920,000 | 2,845,000 | $ 2,716,000 | |||
Amortization of debt discount | $ 256,000 | $ 193,000 | $ 653,000 | $ 557,000 | |||
Effective interest rate of loan | 12.90% | 12.90% | |||||
Principal payments | $ 0 | ||||||
Hercules Loan Agreement | Subsequent Event | |||||||
Schedule Of Long Term Debt [Line Items] | |||||||
Line of credit facility periodic payment | $ 800,000 | ||||||
Hercules Loan Agreement | Prime Rate | |||||||
Schedule Of Long Term Debt [Line Items] | |||||||
Debt instrument variable percentage | 3.75% | ||||||
Hercules Loan Agreement | Maximum | Period Two | |||||||
Schedule Of Long Term Debt [Line Items] | |||||||
Debt instrument prepayment premium, percentage | 1% | 1% | |||||
Hercules Second Amended Loan Agreement | Min Cash Test Date 2 | |||||||
Schedule Of Long Term Debt [Line Items] | |||||||
Line of Credit, Covenant, Minimum Cash | $ 20,000,000 | $ 20,000,000 | |||||
Hercules Second Amended Loan Agreement | Min Cash Test Date 1 | |||||||
Schedule Of Long Term Debt [Line Items] | |||||||
Line of Credit, Covenant, Minimum Cash | $ 30,000,000 | $ 30,000,000 |
Long-Term Debt - Schedule of Fu
Long-Term Debt - Schedule of Future Principal Payments and the Final Payments Due (Detail) $ in Thousands | Sep. 30, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 0 |
2023 | 20,050 |
2024 | 13,525 |
Principal amount of long-term debt | $ 33,575 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 9 Months Ended | ||
Nov. 11, 2019 USD ($) ft² | Sep. 30, 2022 USD ($) m² ft² | Dec. 31, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | |||
Operating lease, liability | $ 4,963 | ||
Right-of-use assets | $ 7,606 | $ 8,710 | |
Waltham Lease | |||
Lessee, Lease, Description [Line Items] | |||
Current office space under lease agreement | ft² | 6,000 | ||
Operating lease expiration (years) | 5 years | ||
Current base rent | $ 300 | ||
Lease, term of contract (years) | 5 years | ||
Vienna Lease | |||
Lessee, Lease, Description [Line Items] | |||
Office space | m² | 1,200 | ||
Lease not yet commenced, term of contract | 7 years | ||
Annual base rent | $ 300 | ||
Allston Lease | |||
Lessee, Lease, Description [Line Items] | |||
Current office space under lease agreement | ft² | 28,000 | ||
Lease not yet commenced | $ 1,000 | ||
Lease, renewal term of contract (years) | 5 years |
Leases - Schedule of Components
Leases - Schedule of Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Leases [Abstract] | ||||
Fixed operating lease cost | $ 507 | $ 537 | $ 1,561 | $ 1,554 |
Short-term lease costs | 0 | 0 | 0 | 42 |
Total lease expense | 507 | 537 | 1,561 | 1,596 |
Right-of-use asset obtained in exchange for operating lease liabilities | 0 | 0 | 0 | 1,343 |
Operating cash flows from operating leases | 334 | 314 | 1,014 | 917 |
Sublease income | $ 49 | $ 49 | $ 147 | $ 147 |
Weighted-average remaining lease term-operating leases (in years) | 4 years 2 months 12 days | 4 years 2 months 12 days | ||
Weighted-average discount rate-operating leases | 11.30% | 11.30% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Detail) $ in Thousands | Sep. 30, 2022 USD ($) |
Leases [Abstract] | |
2020 | $ 391 |
2021 | 1,585 |
2022 | 1,350 |
2023 | 1,378 |
2024 | 1,308 |
2025 | 299 |
Total lease payments | 6,311 |
Less: interest | (1,348) |
Operating lease, liability | $ 4,963 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Indemnification Agreements | ||
Contingencies And Commitments [Line Items] | ||
Accrued liabilities | $ 0 | $ 0 |
Common Stock Warrants - Additio
Common Stock Warrants - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||||
Mar. 23, 2021 | Nov. 29, 2019 | Nov. 26, 2019 | Jun. 30, 2022 | Sep. 30, 2022 | Sep. 01, 2022 | Jul. 06, 2022 | Mar. 03, 2022 | Dec. 31, 2021 | Nov. 02, 2020 | Apr. 16, 2019 | |
Class of Stock [Line Items] | |||||||||||
Common stock, shares authorized | 500,000,000 | 500,000,000 | 125,000,000 | ||||||||
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 | |||||||||
Dividends on common stock declared or paid | $ 0 | ||||||||||
Warrant exercise price (usd per share) | $ 1.095 | ||||||||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | $ 0.001 | $ 0.001 | $ 0.01 | $ 0.01 | |||||||
Warrants and rights outstanding, term | 60 months | 5 years | |||||||||
Issued | 64,968,310 | ||||||||||
Class of warrants or rights expiration period (in years) | 30 days | ||||||||||
Class Of Warrant Or Right Issued, Weighted Average Exercise Price | $ 1.10 | ||||||||||
Warrants and Rights Outstanding, Transaction Fees | $ 2,900,000 | ||||||||||
Fair value of warrant liability | $ 310,000 | $ 821,000 | |||||||||
Change in fair value | (3,006,000) | ||||||||||
Warrant Liability | |||||||||||
Class of Stock [Line Items] | |||||||||||
Fair value of warrant liability | 0 | $ 0 | |||||||||
Change in fair value | $ (2,495,000) | ||||||||||
Pre Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Fair value of warrant liability | $ 13,500,000 | ||||||||||
Warrant Liability | |||||||||||
Class of Stock [Line Items] | |||||||||||
Fair value of warrant liability | $ 38,754,000 | $ 41,249,000 | |||||||||
Issuance on March 3 2022 | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrant exercise price (usd per share) | $ 1.80 | ||||||||||
Issuance on July 6 2022 | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrant exercise price (usd per share) | $ 1.50 | ||||||||||
Q2 2022 Private Placement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 37,649,086 | ||||||||||
Class of warrant or right, warrants to purchase of common stock (in shares) | 50,925,365 | ||||||||||
Sale of stock, price per share (in usd per share) | $ 1.095 | ||||||||||
Warrant exercise price (usd per share) | 1.095 | ||||||||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | $ 0.001 | ||||||||||
Proceeds from issuance of common stock before underwriting discounts commissions and other expenses | $ 55,700,000 | ||||||||||
Q2 2022 Private Placement | Pre Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Class of warrant or right, warrants to purchase of common stock (in shares) | 13,276,279 | ||||||||||
Warrant exercise price (usd per share) | $ 1.094 | ||||||||||
Q1 2022 Private Placement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 900,000 | ||||||||||
Sale of stock, price per share (in usd per share) | $ 1.80 | ||||||||||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | $ 0.01 | ||||||||||
Proceeds from issuance of common stock before underwriting discounts commissions and other expenses | $ 3,000,000 | ||||||||||
Q1 2022 Private Placement | Pre Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Class of warrant or right, warrants to purchase of common stock (in shares) | 766,666 | ||||||||||
Warrant exercise price (usd per share) | $ 1.79 | ||||||||||
Class B Warrants | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrant exercise price (usd per share) | $ 15 | ||||||||||
Issued | 5,416,667 | ||||||||||
Pre Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of warrants for purchase of convertible preferred shares (in shares) | 1 |
Common Stock Warrants - Schedul
Common Stock Warrants - Schedule of Outstanding Warrants (Detail) - $ / shares | 3 Months Ended | 9 Months Ended |
Mar. 31, 2022 | Sep. 30, 2022 | |
Warrants [Roll Forward] | ||
Outstanding and exercisable warrants to purchase common shares as of December 31, 2021 | 13,257,160 | 13,257,160 |
Issued | 64,968,310 | |
Exercised | (100) | |
Number of warrants, Outstanding and exercisable warrants, Ending Balance (in shares) | 78,225,370 | |
Class Of Warrant Or Right Issued, Weighted Average Exercise Price | $ 1.10 | |
Warrants, Weighted Average Exercise Price [Roll Forward] | ||
Weighted Average Exercise Price, Outstanding and exercisable warrants, Beginning Balance (in usd per share) | $ 7.96 | 7.96 |
Weighted Average Exercise Price, Outstanding and exercisable warrants, Ending Balance (in usd per share) | $ 2.12 | |
Weighted Average Contractual Term (Years) | 2 years 8 months 19 days | 4 years 3 months 25 days |
Common Stock Warrants - Summary
Common Stock Warrants - Summary of Outstanding Warrants to Purchase Shares of Common Stock (Detail) - USD ($) $ / shares in Units, $ in Thousands | Sep. 30, 2022 | Jul. 06, 2022 | Mar. 03, 2022 | Dec. 31, 2021 | Nov. 09, 2021 | Mar. 23, 2021 | Nov. 02, 2020 | Nov. 29, 2019 |
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 78,225,370 | 13,257,160 | ||||||
Exercise Price (usd per share) | $ 1.095 | |||||||
Class Of Warrant Or Right. Aggregate Proceeds From Warrants Issued | $ 14,500 | $ 1,400 | $ 10,000 | $ 435 | $ 21,000 | |||
Class of Warrant or Right, Additional Exercise Price of Warrants or Rights | $ 0.001 | $ 0.01 | $ 0.01 | $ 0.001 | ||||
Funded | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 1.094 | $ 1.79 | $ 4.97 | $ 8.69 | 11.999 | |||
Class B Warrants | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 15 | |||||||
Issuance On October 25, 2016 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 19.78 | |||||||
Issuance On October 25, 2016 | Legacy Warrants | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 5,155 | |||||||
Issuance On December 28, 2017 One | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 19.78 | |||||||
Issuance On December 28, 2017 One | Legacy Warrants | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 115,916 | |||||||
Issuance On September 12, 2018 One | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 19.78 | |||||||
Issuance On September 12, 2018 One | Legacy Warrants | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 20,220 | |||||||
Issuance On October 19, 2018 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 19.78 | |||||||
Issuance On October 19, 2018 | Legacy Warrants | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 20,016 | |||||||
Issuance On March 13, 2019 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 19.78 | |||||||
Issuance On March 13, 2019 | Legacy Warrants | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 5,000 | |||||||
Issuance On April 16, 2019 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 13.20 | |||||||
Issuance On April 16, 2019 | Class A Warrant | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 3,866,154 | |||||||
Issuance On November 29, 2019 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 1.50 | |||||||
Issuance On November 29, 2019 | Class B Warrants | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 5,416,567 | |||||||
Issuance On November 29, 2019 One | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 12 | |||||||
Issuance On November 29, 2019 One | Pre Funded Warrant | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 1,750,000 | |||||||
Issuance On March 23, 2021 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise Price (usd per share) | $ 8.70 | |||||||
Issuance On March 23, 2021 | Pre Funded Warrant | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 50,000 | |||||||
Issuance on November Nine Two Thousand Twenty One | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 2,008,032 | |||||||
Exercise Price (usd per share) | $ 4.98 | |||||||
Issuance on March 3 2022 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 766,666 | |||||||
Exercise Price (usd per share) | $ 1.80 | |||||||
Issuance on July 2022 1 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 13,276,279 | |||||||
Exercise Price (usd per share) | $ 1.094 | |||||||
Issuance on July 6 2022 Two | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of Shares of Common Stock Issuable (in shares) | 50,925,365 | |||||||
Exercise Price (usd per share) | $ 1.095 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate intrinsic value, options exercised | $ 13 | |
Options granted, weighted average grant date fair value (in usd per share) | $ 1.24 | $ 5.39 |
Restricted Stock Units (RSUs) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation cost of stock based awards | $ 5,000 | |
Unrecognized compensation cost of stock based awards, recognition period | 1 year 8 months 12 days | |
2019 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares reserved for issuance | 1,200,000 | |
Two Thousand Seventeen Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares reserved for issuance | 196,000 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Assumptions Used in Black-Scholes Option-Pricing Model to Determine Grant-date Fair Value of Stock Options Granted (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | ||||
Risk-free interest rate (in percentage) | 3.30% | 1.10% | 2.40% | 1% |
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years |
Expected volatility (in percentage) | 95.70% | 95.70% | 94.80% | 97.60% |
Expected dividend yield (in percentage) | 0% | 0% | 0% | 0% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Number of Shares | ||
Beginning balance (in shares) | 1,916,051 | |
Granted (in shares) | 339,950 | |
Forfeited (in shares) | (412,328) | |
Ending balance (in shares) | 1,843,673 | 1,916,051 |
Number of shares Options, Exercisable (in shares) | 1,119,308 | |
Number of shares Options, Vested and expected to vest (in shares) | 1,670,385 | |
Weighted Average Exercise Price | ||
Beginning balance (in usd per share) | $ 10.01 | |
Granted (in usd per share) | 1.60 | |
Forfeited (in usd per share) | 11.59 | |
Ending balance (in usd per share) | 8.11 | $ 10.01 |
Weighted average exercise price, Exercisable (in usd per share) | 10.12 | |
Weighted average exercise price, Vested and expected to vest (in usd per share) | $ 8.52 | |
Weighted average contractual term outstanding (in years) | 6 years 6 months | 7 years 9 months 18 days |
Weighted average contractual term outstanding, Exercisable (in years) | 6 years 6 months | |
Weighted average contractual term outstanding, Vested and expected to vest (in years) | 7 years 2 months 12 days | |
Aggregate intrinsic value, Beginning balance | $ 0 | |
Aggregate intrinsic value, Ending balance | 73 | $ 0 |
Aggregate intrinsic value, exercisable | 0 | |
Aggregate intrinsic value, vested and expected to vest | $ 46 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) | 9 Months Ended |
Sep. 30, 2022 shares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Granted (in shares) | 1,289,425 |
Vested (in shares) | (384,814) |
Forfeited (in shares) | (431,923) |
Nonvested ending balance (in shares) | 1,397,789 |
Restricted Stock Units (RSUs) | |
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 |
Stock-Based Compensation Summar
Stock-Based Compensation Summary of Stock-Based Compensation Expense Classification (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 1,111 | $ 1,516 | $ 4,092 | $ 4,571 |
Research and development expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | 576 | 633 | 1,990 | 2,008 |
Selling, general and administrative expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 535 | $ 883 | $ 2,102 | $ 2,563 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
Federal income tax benefit | $ 0 | $ 0 | ||
State income tax benefit | 0 | 0 | ||
Provision for income taxes | $ (13) | $ 2 | $ 14 | $ 14 |
Net Loss per Share - Summary of
Net Loss per Share - Summary of Basic and Diluted Net loss per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator: | ||||||||
Net loss | $ (21,586) | $ (21,212) | $ (21,965) | $ (20,175) | $ (19,638) | $ (18,676) | $ (64,763) | $ (58,489) |
Dividends, Paid-in-kind | (287) | 0 | (2,546) | (8,239) | ||||
Net loss attributable to common stockholders | $ (21,873) | $ (20,175) | $ (67,309) | $ (66,728) | ||||
Denominator: | ||||||||
Weighted average shares of common stock outstanding—basic | 83,211,000 | 26,609,000 | 50,976,000 | 24,667,000 | ||||
Weighted average shares of common stock outstanding—diluted | 83,211,000 | 26,609,000 | 50,976,000 | 24,667,000 | ||||
Net loss per share attributable to common stockholders—basic | $ (0.26) | $ (0.76) | $ (1.32) | $ (2.71) | ||||
Net loss per share attributable to common stockholders—diluted | $ (0.26) | $ (0.76) | $ (1.32) | $ (2.71) |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Detail) - $ / shares | Sep. 30, 2022 | Jul. 06, 2022 |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Exercise Price (usd per share) | $ 1.095 | |
Pre Funded Warrant | Maximum | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Exercise Price (usd 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 (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted net loss per share (in shares) | 63,615,855 | 12,308,892 | 63,615,855 | 12,308,892 |
Employee Stock Option | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted net loss per share (in shares) | 1,843,673 | 1,952,891 | 1,843,673 | 1,952,891 |
Restricted Stock Units (RSUs) | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted net loss per share (in shares) | 1,397,789 | 906,873 | 1,397,789 | 906,873 |
Warrant Liability | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted net loss per share (in shares) | 60,374,393 | 9,449,128 | 60,374,393 | 9,449,128 |