Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 17, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Current Fiscal Year End Date | --12-31 | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Transition Report | false | ||
Entity File Number | 000-28386 | ||
Entity Registrant Name | CTI BIOPHARMA CORP. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 91-1533912 | ||
Entity Address, Address Line One | 3101 Western Avenue | ||
Entity Address, Address Line Two | Suite 800 | ||
Entity Address, City or Town | Seattle | ||
Entity Address, State or Province | WA | ||
Entity Address, Postal Zip Code | 98121 | ||
City Area Code | 206 | ||
Local Phone Number | 282-7100 | ||
Title of 12(b) Security | Common Stock, $0.001 par value per share | ||
Trading Symbol | CTIC | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 210.4 | ||
Entity Common Stock, Shares Outstanding | 99,917,628 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement relating to its 2022 annual meeting of stockholders, or the 2022 Proxy Statement, are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. We expect to file the 2022 Proxy Statement with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0000891293 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Auditor Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Seattle, Washington |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 65,446 | $ 40,394 |
Short-term investments | 0 | 12,057 |
Prepaid expenses and other current assets | 2,933 | 1,874 |
Total current assets | 68,379 | 54,325 |
Property and equipment, net | 176 | 719 |
Other assets | 3,879 | 3,197 |
Total assets | 72,434 | 58,241 |
Current liabilities: | ||
Accounts payable | 3,891 | 1,637 |
Accrued expenses | 12,720 | 7,191 |
Current portion of long-term debt | 47,380 | 4,455 |
Other current liabilities | 2,660 | 3,755 |
Total current liabilities | 66,651 | 17,038 |
Other liabilities, less current portion | 2,016 | 1,174 |
Total liabilities | 68,667 | 18,212 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Common stock | 100 | 76 |
Additional paid-in capital | 2,429,582 | 2,367,958 |
Accumulated other comprehensive income | 0 | 2 |
Accumulated deficit | (2,425,915) | (2,328,007) |
Total stockholders' equity | 3,767 | 40,029 |
Total liabilities and stockholders' equity | 72,434 | 58,241 |
Series O Preferred Stock | ||
Stockholders' equity: | ||
Preferred stock | 0 | 0 |
Series X Preferred Stock | ||
Stockholders' equity: | ||
Preferred stock | 0 | 0 |
Series X1 Preferred Stock | ||
Stockholders' equity: | ||
Preferred stock | $ 0 | $ 0 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Preferred stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 33,333 | 33,333 |
Common stock par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 266,500,000 | 166,500,000 |
Common stock issued (in shares) | 99,763,922 | 75,896,884 |
Common stock outstanding (in shares) | 99,763,922 | 75,896,884 |
Series O Preferred Stock | ||
Preferred stock issued (in shares) | 12,575 | 12,575 |
Preferred stock outstanding (in shares) | 12,575 | 12,575 |
Preferred stock liquidation preference | $ 25,150 | $ 25,150 |
Series X Preferred Stock | ||
Preferred stock issued (in shares) | 3,794 | 4,429 |
Preferred stock outstanding (in shares) | 3,794 | 4,429 |
Preferred stock liquidation preference | $ 37,940 | $ 44,290 |
Series X1 Preferred Stock | ||
Preferred stock issued (in shares) | 600 | 0 |
Preferred stock outstanding (in shares) | 600 | 0 |
Preferred stock liquidation preference | $ 15,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating costs and expenses: | ||
Research and development | $ 39,136 | $ 25,943 |
Selling, general and administrative | 56,196 | 17,626 |
Other operating expense | 0 | 4,200 |
Total operating costs and expenses | 95,332 | 47,769 |
Loss from operations | (95,332) | (47,769) |
Non-operating expense: | ||
Interest expense, net | (2,415) | (828) |
Other non-operating expenses | (161) | (3,854) |
Total non-operating expense | (2,576) | (4,682) |
Net loss | $ (97,908) | $ (52,451) |
Net loss per common share: Basic (in dollars per share) | $ (1.09) | $ (0.74) |
Net loss per common share: Diluted (in dollars per share) | $ (1.09) | $ (0.74) |
Shares used in calculation of net loss per common share, basic (in shares) | 90,117 | 71,141 |
Shares used in calculation of net loss per common share, diluted (in shares) | 90,117 | 71,141 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (97,908) | $ (52,451) |
Other comprehensive (loss) income: | ||
Change in unrealized (loss) gain on available-for-sale securities | (2) | 2 |
Other comprehensive loss | (2) | 2 |
Comprehensive loss | $ (97,910) | $ (52,449) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Common Stock And Series X Preferred Stock | Common Stock and Series X1 Preferred Stock | Preferred Stock | Preferred StockCommon Stock And Series X Preferred Stock | Preferred StockCommon Stock and Series X1 Preferred Stock | Common Stock | Common StockCommon Stock | Common StockCommon Stock And Series X Preferred Stock | Common StockCommon Stock and Series X1 Preferred Stock | Additional Paid-in Capital | Additional Paid-in CapitalCommon Stock | Additional Paid-in CapitalCommon Stock And Series X Preferred Stock | Additional Paid-in CapitalCommon Stock and Series X1 Preferred Stock | Accumulated Other Comprehensive Loss | Accumulated Deficit | Noncontrolling Interest |
Beginning Balance (in shares) at Dec. 31, 2019 | 13 | 57,980 | ||||||||||||||||
Beginning Balance at Dec. 31, 2019 | $ 17,930 | $ 0 | $ 58 | $ 2,299,186 | $ 0 | $ (2,275,556) | $ (5,758) | |||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 4 | 2,071 | 15,699 | |||||||||||||||
Issuance of common stock, net of issuance costs | $ 22,609 | $ 43,653 | $ 2 | $ 16 | $ 22,607 | $ 43,637 | ||||||||||||
Conversion of Series X preferred stock to common stock (in shares) | 3 | |||||||||||||||||
Conversion of Series X preferred stock to common stock | 3 | 3 | ||||||||||||||||
Dissolution of majority-owned subsidiary | 3,809 | (1,949) | 5,758 | |||||||||||||||
Equity-based compensation | 4,317 | 4,317 | ||||||||||||||||
Exercise of stock options and shares issued under employee stock purchase plan (in shares) | 144 | |||||||||||||||||
Exercise of stock options and shares issued under employee stock purchase plan | 157 | 157 | ||||||||||||||||
Net loss | (52,451) | (52,451) | ||||||||||||||||
Other comprehensive loss | 2 | 2 | ||||||||||||||||
Ending Balance (in shares) at Dec. 31, 2020 | 17 | 75,897 | ||||||||||||||||
Ending Balance at Dec. 31, 2020 | 40,029 | $ 0 | $ 76 | 2,367,958 | 2 | (2,328,007) | 0 | |||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 1 | 858 | 16,400 | |||||||||||||||
Issuance of common stock, net of issuance costs | $ 2,962 | $ 53,553 | $ 1 | $ 16 | $ 2,961 | $ 53,537 | ||||||||||||
Conversion of Series X preferred stock to common stock (in shares) | (1) | 6,350 | ||||||||||||||||
Conversion of Series X preferred stock to common stock | 0 | $ 7 | (7) | |||||||||||||||
Equity-based compensation | 4,743 | 4,743 | ||||||||||||||||
Exercise of stock options and shares issued under employee stock purchase plan (in shares) | 263 | |||||||||||||||||
Exercise of stock options and shares issued under employee stock purchase plan | 390 | 390 | ||||||||||||||||
Cancellation of restricted stock (in shares) | (4) | |||||||||||||||||
Net loss | (97,908) | (97,908) | ||||||||||||||||
Other comprehensive loss | (2) | (2) | ||||||||||||||||
Ending Balance (in shares) at Dec. 31, 2021 | 17 | 99,764 | ||||||||||||||||
Ending Balance at Dec. 31, 2021 | $ 3,767 | $ 0 | $ 100 | $ 2,429,582 | $ 0 | $ (2,425,915) | $ 0 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities | ||
Net loss | $ (97,908) | $ (52,451) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Equity-based compensation expense | 4,743 | 4,317 |
Depreciation and amortization | 526 | 532 |
Provision for Italian VAT receivables and deposit | 0 | 4,200 |
Loss on dissolution of majority-owned subsidiary | 0 | 3,774 |
Other | (113) | (155) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 2,278 | 2,274 |
Accounts payable, accrued expenses and other liabilities | 5,585 | (4,696) |
Net cash used in operating activities | (84,889) | (42,205) |
Investing activities | ||
Purchases of property and equipment | 0 | (17) |
Purchases of short-term investments | 0 | (12,100) |
Proceeds from maturities of short-term investments | 12,000 | 2,500 |
Net cash provided by (used in) investing activities | 12,000 | (9,617) |
Financing activities | ||
Repayment of Silicon Valley Bank debt | (6,329) | (5,333) |
Proceeds from stock option exercises and ESPP stock issuance | 408 | 140 |
Net cash provided by financing activities | 97,941 | 61,072 |
Net increase in cash and cash equivalents | 25,052 | 9,250 |
Cash and cash equivalents at beginning of year | 40,394 | 31,144 |
Cash and cash equivalents at end of year | 65,446 | 40,394 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 1,950 | 547 |
Supplemental disclosure of noncash financing and investing activities | ||
Conversion of preferred stock to common stock | 6,350 | 0 |
Drug Royalty III LP 2 Credit Agreement | ||
Financing activities | ||
Gross proceeds from DRI Credit Agreement | 50,000 | 0 |
Cash paid for issuance costs | (1,813) | 0 |
Royalty Financing Agreement | ||
Financing activities | ||
Cash paid for issuance costs | (531) | 0 |
Common And Preferred Stock | ||
Financing activities | ||
Cash paid for offering costs | 0 | (883) |
Gross proceeds from offering | 0 | 59,991 |
At-The-Market Equity, Common Stock | ||
Financing activities | ||
Cash paid for offering costs | (411) | (221) |
Gross proceeds from offering | 3,064 | 7,378 |
Common Stock and Series X1 Preferred Stock | ||
Financing activities | ||
Gross proceeds from public offering of common stock and Series X1 preferred stock | 56,000 | 0 |
Cash paid for offering costs | $ (2,447) | $ 0 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Description of Business and Summary of Significant Accounting Policies | 1. Description of Business and Summary of Significant Accounting Policies CTI BioPharma Corp. and our subsidiaries, also referred to in this Annual Report on Form 10-K as “we,” “us,” “our,” the “Company” and “CTI,” is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers where there is a significant unmet medical need. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with partners. We have one commercially approved product, VONJO™ (pacritinib), which received accelerated approval in February 2022 from the the FDA in the United States, for the treatment of adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 x 10 9 /L. We commercially launched VONJO in the first quarter of 2022. We operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products requires approval from, and is subject to, ongoing oversight by the FDA in the United States, the EMA in the EU, and comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve the expenditure of substantial resources. Principles of Consolidation The accompanying consolidated financial statements include the accounts of our majority-owned subsidiary, Aequus Biopharma, Inc., or Aequus, until its dissolution in June 2020. We had an approximately 60% interest in Aequus; the remaining interest not held by CTI was reported as noncontrolling interest in the consolidated financial statements until its dissolution. All intercompany transactions and balances were eliminated in consolidation through the June 2020 Aequus dissolution. The accompanying consolidated financial statements do not include the accounts of subsidiaries since July 2020. Liquidity The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the consolidated financial statements are issued. Our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued. Over the next year and in the normal course of business, we expect to increase our spend on our VONJO commercialization efforts as well as conduct research, development, testing and regulatory compliance activities with respect to other development pathways for pacritinib. While we expect revenues from VONJO to increase after its initial launch, we cannot accurately predict the market acceptance or growth trajectory of VONJO's revenues. Further, we will incur selling, general and administrative expenses. Additional anticipated business activities include procuring clinical drug supplies and establishing commercial supplies of our commercial product, the costs of which, together with our projected selling, general and administrative expenses, when offset against our projected revenues, are expected to result in operating losses for the foreseeable future. We have incurred a net operating loss every year since our formation. As of December 31, 2021, we had an accumulated deficit of $2.4 billion. Our available cash and cash equivalents were $65.4 million as of December 31, 2021. We expect that our present financial resources, combined with $60.0 million received from Drug Royalty III LP 2 following FDA approval of VONJO in February 2022, will be sufficient to meet our obligations as they come due and to fund our operations into the fourth quarter of 2022. Based on our evaluation completed pursuant to Accounting Standard Codification subtopic 205-40 Going Concern, these factors raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued, or through the first quarter of 2023. We will require additional capital in order to pursue our strategic objectives. We expect to satisfy our capital needs through existing capital balances, revenue from VONJO, and some combination of public or private equity financings, partnerships, collaborations, joint ventures, debt financings or restructurings, bank borrowings or other sources of financing. However, we have a limited number of authorized shares of common stock available for issuance and additional funding may not be available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing stockholders may result. If we fail to obtain additional capital when needed, our ability to operate as a going concern will be harmed, and we may be required to delay, scale back or eliminate some or all of our research and development programs and commercialization efforts and/or reduce our selling, general and administrative expenses, be unable to attract and retain highly-qualified personnel, be unable to obtain and maintain contracts necessary to continue our operations and at affordable rates with competitive terms, refrain from making our contractually required payments when due (including debt payments) and/or be forced to cease operations, liquidate our assets and possibly seek bankruptcy protection. Our future capital requirements will depend on many factors, including: our ability to generate sales of VONJO; the cost and timing of establishing our commercial infrastructure and distribution capabilities; our ability to reach milestones triggering payments under certain of our contractual arrangements; the cost of manufacturing VONJO; the cost of manufacturing clinical supplies of our product candidates or of establishing commercial supplies of any products that we may develop in the future; developments in and expenses associated with our research and development activities; our clinical development plans and any changes that we may initiate or that may be requested by the FDA or other regulators as we seek product approval; acquisitions or collaborations with respect to compounds or other assets; competitive market developments; disruptions or other delays to our business and clinical trials resulting from the ongoing worldwide COVID-19 pandemic; and other unplanned business developments. In addition, our ability to comply with covenants under our Credit Agreement with Drug Royalty III LP 2 may be affected by events beyond our control, and we may not be able to meet those covenants. A breach of any of these covenants, including a material adverse change in our business, operations or condition (financial or otherwise), could result in an event of default under the Credit Agreement, which could cause all of the outstanding indebtedness under the facility to become immediately due and payable. See “Note 7. Debt Financing Arrangements” for additional details. The accompanying consolidated financial statements do not include adjustments, if any, that may result from the outcome of this uncertainty. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosures of loss contingencies in the consolidated financial statements and accompanying notes. Estimates are used for, but not limited to, clinical accruals, income taxes, commitments and contingencies, and equity-based compensation forfeiture rates. Given the global economic climate and additional or unforeseen effects from the ongoing COVID-19 pandemic, these estimates are becoming more challenging, and actual results could differ materially from those estimates. Segment Information We view our operations and manage our business in a single operating segment focused on the business of acquiring, developing and commercializing novel targeted therapies for blood-related cancers. All of our tangible assets are held in the United States. Certain Risks, Uncertainties and Concentrations Cash, cash equivalents and marketable securities are financial instruments which potentially subject us to concentrations of credit risk. We have not experienced any significant credit losses on cash, cash equivalents, or marketable securities to date. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. We source our drug products for commercial operations and clinical trials from a concentrated group of third-party contractors. If we are unable to obtain sufficient quantities of source materials, manufacture or distribute our products to customers from existing suppliers and service providers, or obtain the materials or services from other suppliers or manufacturers, certain sales and research and development activities may be delayed. Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest: • Level 1—Valuations based on unadjusted quoted prices for identical assets and liabilities in active markets. • Level 2—Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Valuations based on unobservable inputs that are supported by little or no market activity, reflecting our own assumptions. These valuations require significant judgment or estimation. Our cash equivalents and short-term investments are recorded at fair value. As of December 31, 2021, our cash and cash equivalents consisted of cash and money market funds. As of December 31, 2020, our cash, cash equivalents and short-term investments consisted of cash, money market funds and corporate debt securities. We measure the fair value of money market funds based on the closing price reported by the fund sponsor from an actively traded exchange. We value all other securities using broker quotes that utilize observable market inputs. We did not hold cash, cash equivalents and short-term investments categorized as Level 3 assets as of December 31, 2021 and 2020. The following table summarizes, by major security type, our cash, cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): December 31, 2021 December 31, 2020 Cost or Amortized Cost Gross Unrealized Gains / (Losses) Total Estimated Fair Value Total Estimated Cash $ 137 $ — $ 137 $ 385 Level 1 securities: Money market funds 65,309 — 65,309 40,009 Level 2 securities: Corporate debt securities — — — 12,057 Total cash, cash equivalents and short-term investments $ 65,446 $ — $ 65,446 $ 52,451 We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if we have experienced a credit loss and have the intent to sell the investment or if it is more likely than not that we will be required to sell the investment before recovery of the amortized cost basis. At December 31, 2021 and 2020, the carrying value of our payables and accruals approximated their fair values due to their short-term maturities. The carrying value of our long-term debt approximated its fair value at December 31, 2021 and 2020 based on borrowing rates for similar loans and maturities. Cash and Cash Equivalents We consider all highly liquid instruments with original maturities of three months or less at the time acquired to be cash equivalents. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. Italian Value Added Tax As disclosed in “Note 13. Commitments and Contingencies , ” the Italian Tax Authority, or the ITA, assessed us for additional VAT payments for services we provided in Italy, which we do not believe we owe. We have not recorded an amount in the financial statements for this contingent liability as we do not believe the potential payment of up to €4.4 million (or approximately $4.9 million converted using the currency exchange rate as of December 31, 2021) to the ITA is probable at this time. Leases Under ASC 842 - Leases , we determine if an arrangement is a lease at inception. We recognize a right-of-use asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as operating or finance at lease commencement, which will affect the pattern and classification of expense recognition in our consolidated statements of operations. Right-of-use assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As our leases do not provide a readily determinable implicit rate of return, we derive the present value of lease payments using our incremental borrowing rate, which is the rate of interest that we would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. An operating lease right-of-use asset is measured at the amount of the lease liability, adjusted for prepaid or accrued lease payments, lease incentives received, unamortized initial direct costs and the impairment of the right-of-use asset. A lease may include options to extend or terminate the lease. When it is reasonably certain that we will exercise such an option, it is considered in the lease term. Right-of-use assets are tested for impairment in the same manner as long-lived assets used in operations. Lease expense for operating leases is recognized on a straight-line basis over the lease term as part of Research and development expenses and Selling, general and administrative expenses in our consolidated statements of operations. Right-of-use assets are included in Other assets , and the current portion of lease liabilities and the non-current portion of lease liabilities are included in Other current liabilities and Other liabilities , respectively, in our consolidated balance sheets. Property and Equipment Property and equipment are carried at cost, less accumulated depreciation and amortization. Depreciation commences at the time assets are placed in service. We calculate depreciation using the straight-line method over the estimated useful lives of the assets, ranging from three Impairment of Long-lived Assets We review our long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. If an impairment is indicated, the asset is written down to its estimated fair value. Contingencies We record liabilities associated with loss contingencies to the extent that we conclude that the occurrence of the contingency is probable and that the amount of the related loss is reasonably estimable. We record income from gain contingencies only upon the realization of assets resulting from the favorable outcome of the contingent event. See “Note 9. Collaboration, Licensing and Milestone Agreements” and “Note 13. Commitments and Contingencies” for further information regarding our current contingencies. Research and Development Expenses Research and development costs are expensed as incurred in accordance with ASC 730, Research and Development . Research and development expenses include related salaries and benefits, clinical trial and related manufacturing costs, contract and other outside service fees, and facilities and overhead costs related to our research and development efforts. Research and development expenses also consist of costs incurred for proprietary and collaboration research and development and include activities such as product registries and investigator-sponsored trials. In instances where we enter into agreements with third parties for research and development activities, we may prepay fees for services at the initiation of the contract. We record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Other types of arrangements with third parties may be fixed fee or fee for service, and may include monthly payments or payments upon completion of milestones or receipt of deliverables. We expense upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. Equity-Based Compensation Expense Equity-based compensation expense for all equity-based payment awards made to employees and directors is measured based on the grant-date fair value estimated in accordance with U.S. GAAP. We recognize equity-based compensation using the straight-line, single-award method based on the value of the portion of equity-based payment awards that is ultimately expected to vest. We apply estimated forfeiture rates at the time of grant and make revisions, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For performance-based awards that do not include market-based conditions, we record equity-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. Income Taxes The provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, and for operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the currently enacted tax rates in effect for the years in which those tax assets and liabilities are expected to be realized or settled. We provide a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized. Net Loss per Share Basic net loss per common share is calculated based on net loss divided by the weighted average number of shares outstanding for the period. The calculation of diluted net loss per common share excludes the potential conversion of all dilutive convertible securities, such as convertible preferred stock, using the if-converted method, and the potential exercise or vesting of other dilutive securities, such as options, warrants and restricted stock, using the treasury stock method, as their inclusion would have an anti-dilutive effect. Recently Adopted Accounting Standards In August 2020, the FASB issued new accounting guidance for convertible instruments which eliminates two of the three models in ASC 470-20 that require separate accounting for embedded conversion features. Separate accounting is still required in certain cases. For smaller reporting companies, the guidance is effective for fiscal years beginning after December 15, 2023, including interim periods therein. Early adoption is permitted in fiscal years beginning after December 15, 2020. We early adopted this guidance as of January 1, 2021. In April 2021, as discussed in “Note 8. Equity Transactions,” we completed the public offering of our common stock and our Series X 1 Preferred Stock. No beneficial conversion feature was recognized on Series X 1 Preferred Stock upon issuance. Recently Issued Accounting Standards In March 2020, the FASB issued new accounting guidance to provide temporary optional expedients to ease the potential burden in accounting for reference rate reform. The guidance includes an optional expedient that simplifies accounting for contract modifications to loans receivable and debt, by prospectively adjusting the effective interest rate. The accounting guidance is effective as of January 7, 2021 through December 31, 2022. As discussed in “Note 7. Debt Financing Arrangements,” in August 2021, we entered into a Credit Agreement, which has an interest rate referenced to the London Interbank Offered Rate, or LIBOR. We plan to elect the optional expedient for our credit facility by prospectively adjusting the effective interest rate if the cessation of the LIBOR occurs. We do not expect the adoption of this guidance to have a material impact on our consolidated financial statements. Although there were several other new accounting pronouncements issued or proposed by the FASB, we do not believe any of these have had or will have a material impact on our consolidated financial statements. Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 2. Property and Equipment Property and equipment consisted of the following as of December 31, 2021 and 2020 (in thousands): 2021 2020 Furniture and office equipment $ 597 $ 663 Leasehold improvements 5,140 5,140 5,737 5,803 Less: accumulated depreciation and amortization (5,561) (5,084) Property and equipment, net $ 176 $ 719 |
Other Assets
Other Assets | 12 Months Ended |
Dec. 31, 2021 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Assets | 3. Other Assets Other assets consisted of the following as of December 31, 2021 and 2020 (in thousands): 2021 2020 Right-of-use assets $ 3,109 $ 2,149 Clinical trial deposits 770 770 Refundable security deposit — 194 Other — 84 Total other assets $ 3,879 $ 3,197 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 4. Accrued Expenses Accrued expenses consisted of the following as of December 31, 2021 and 2020 (in thousands): 2021 2020 Clinical trial expenses $ 4,053 $ 3,512 Employee compensation and related expenses 4,783 2,792 Commercial expenses 3,075 — Manufacturing expenses 288 238 Other 521 649 Total accrued expenses $ 12,720 $ 7,191 |
Other Current Liabilities
Other Current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Other Liabilities Disclosure [Abstract] | |
Other Current Liabilities | 5. Other Current Liabilities Other current liabilities consisted of the following as of December 31, 2021 and 2020 (in thousands): 2021 2020 Operating lease liabilities - current $ 1,160 $ 2,194 End-of-facility lender fee (1) 1,000 1,440 Other current obligations 500 121 Total other current liabilities $ 2,660 $ 3,755 (1) The end-of-facility lender fee as of December 31, 2021 represents an amount payable to Drug Royalty III LP 2, or DRI, upon repayment of our secured term loan under the Credit Agreement with DRI. The end-of-facility lender fee as of December 31, 2020 represents an amount payable to Silicon Valley Bank upon repayment of our secured term loan, which was repaid in August 2021. See “Note 7. Debt Financing Arrangements” for additional information. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 6. Leases In January 2012, we entered into an agreement with Selig Holdings Company LLC, or Selig, to lease approximately 66,000 square feet of office space in Seattle, Washington for a term of 10 years, commencing May 2012 and expiring April 2022. We had two five-year options to extend the term of the lease at a market rate determined according to the lease. We also had an option to early terminate the lease after the fifth anniversary from the commencement date. We were provided with a total of $3.9 million for certain tenant improvements and other lease incentives. The options to extend or terminate the lease were not considered in the determination of the right-of-use asset and the lease liability as we did not consider it reasonably certain that we would exercise such options. We also lease parking space under the agreement and had certain office equipment leases until October 2020. We have elected not to separate a non-lease component from a lease component for these leases. In December 2017, we entered into an agreement to sublease approximately 44,000 square feet of our office space. No payments were due through May 2018, after which monthly rent is due through the sublease termination date in April 2022. In December 2021, we entered into an amendment to extend the term of the existing lease by 3 years to April 2025 and to reduce the leased office space, beginning May 2022, to approximately 23,000 square feet. We were also provided with certain tenant improvement costs of up to $50,000. The amendment provides for one five-year option to extend the term of the lease at a market rate at the time of such extension. The option to extend the lease was not considered in the remeasurement of lease liability and the adjustment of the right-of-use asset as we did not consider it reasonably certain that we would exercise such option. The amended lease will continue to be classified as an operating lease. As a result of this amendment, the lease liability balance as well as the right-of-use asset balance increased by $2.4 million as of the effective date. The operating lease for our office space includes common area maintenance services provided by Selig, which are considered a non-lease component. Since the payments for these services are based on the actual costs incurred by Selig in providing the services, we consider these payments as variable lease expenses. The components of lease expense, which were included in our consolidated statements of operations, were as follows (in thousands): Year Ended December 31, 2021 2020 Operating lease expense $ 1,586 $ 1,653 Variable lease expense 183 230 Sublease income (1,254) (1,247) Total lease expense, net $ 515 $ 636 The balance sheet classification of operating lease right-of-use assets and operating lease liabilities were as follows (in thousands): December 31, 2021 Right-of-use assets (included in Other Assets ) $ 3,109 Operating lease liabilities, current (included in Other current liabilities ) $ 1,160 Operating lease liabilities, non-current (included in Other liabilities, less current portion ) 2,016 Total lease liabilities $ 3,176 As of December 31, 2021, the maturities of operating lease liabilities were as follows (in thousands): Operating Sublease Lease Payments Rental Receipts Net 2022 $ 1,450 $ (499) $ 951 2023 976 — 976 2024 1,002 — 1,002 2025 337 — 337 Thereafter — — — Total payments 3,765 $ (499) $ 3,266 Less imputed interest (589) Total lease liabilities $ 3,176 Supplemental information relating to our operating leases is as follows (in thousands): December 31, 2021 Supplemental cash flow information Cash paid for amounts included in the measurement of lease liabilities $ 2,435 Right-of-use assets obtained in exchange for operating lease liabilities due to lease amendment $ 2,384 Weighted-average remaining lease term of operating leases (years) 3.33 Weighted-average discount rate of operating leases 11.6 % |
Debt Financing Agreements
Debt Financing Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt Financing Agreements | 7. Debt Financing Arrangements Silicon Valley Bank In August 2021, in connection with the Credit Agreement we entered into with Drug Royalty III LP 2 as discussed below, we repaid the then-outstanding principal balance of $1.3 million under our loan agreement with Silicon Valley Bank in full, along with the end-of-facility lender fee of $1.4 million and the prepayment premium of $40,000. Accordingly, with respect to the loan agreement with Silicon Valley Bank, among other things, (1) all obligations have been paid, satisfied, released and discharged in full, (2) all unfunded commitments to make credit extensions or financial accommodations to us or any other person under the loan agreement have been automatically and irrevocably terminated, and (3) all related documents have been automatically and irrevocably terminated (other than with respect to customary provisions and agreements that are expressly specified to survive the termination). Upon full repayment of the principal in August 2021, we recorded a loss on debt extinguishment of $0.1 million in Other non-operating expense for the year ended December 31, 2021. Drug Royalty III LP 2 Credit Agreement In August 2021, we entered into a Credit Agreement with Drug Royalty III LP 2, or DRI, as lender and as administrative agent for the lenders, and received a term loan in the principal amount of $50.0 million under the Credit Agreement, or the Term Loan, with a maturity date of August 25, 2026. The Credit Agreement provides for quarterly interest-only payments until the maturity date, with the unpaid principal amount of the Term Loan due and payable on the maturity date. The Term Loan bears interest at a rate equal to the greater of (i) 1.75% per annum and (ii) the three-month LIBOR rate, plus 8.25% (or, upon the occurrence of and during the continuance of any event of default, plus 10.25% per annum). Our obligations under the Credit Agreement are secured by a first priority security interest in substantially all of our assets, subject to certain exceptions. We are required to make mandatory prepayments of the Term Loan with the proceeds of certain asset sales, certain VONJO out-licensing or royalty monetization transactions (excluding the Royalty Sale contemplated under the Royalty Purchase Agreement discussed below), extraordinary receipts, debt issuances, or upon a change of control of the Company and specified other events, subject to certain exceptions. We may make voluntary prepayments in whole or in part. Prepayments prior to the fourth anniversary of the closing date are subject to a prepayment premium, which declines over time following the second anniversary of the closing date. Upon the prepayment or repayment, including at maturity, of all or any portion of the Term Loan, we are obligated to pay an exit fee in an amount equal to 2.00% of the principal amount of the Term Loan prepaid or repaid, which is recorded in Other current liabilities . See “Note 5. Other Current Liabilities” for additional information. In addition, the Term Loan was subject to a 1.00% commitment fee due and payable on the closing date. The Credit Agreement contains representations and warranties and affirmative and negative covenants customary for financings of this nature, as well as customary events of default. Certain of the customary negative covenants limit our ability to, among other things, grant liens, make investments, incur additional indebtedness, dispose of assets, license certain property, distribute dividends, make certain restricted payments, change the nature of our business, engage in transactions with affiliates and insiders, prepay other indebtedness, or engage in sale and leaseback transactions, subject to certain exceptions. The Credit Agreement contains a minimum liquidity covenant requiring us to maintain at least $10.0 million of unrestricted cash and cash equivalents, subject to certain exceptions. A failure to comply with the covenants in the Credit Agreement could permit the Lenders under the Credit Agreement to declare the outstanding principal as well as accrued interest and fees to be immediately due and payable. In addition, the Credit Agreement contains an affirmative covenant requiring us to deliver to DRI, within 120 days after the end of each fiscal year, audited financial statements of the Company accompanied by an unqualified report and opinion of an independent certified public accountant, which report and opinion shall not be subject to any “going concern” or like qualification or exception. We have obtained a waiver of breach of such covenant from DRI since the report of independent registered public accounting firm contained within this Annual Report on Form 10-K states that substantial doubt exists about our ability to continue as a going concern. We may need to obtain similar waivers at future annual reporting dates if substantial doubt continues to exist. As of December 31, 2021, we had an outstanding Term Loan principal balance of $50.0 million under the Credit Agreement. In connection with the Credit Agreement, we recorded debt discount and debt issuance costs of $1.5 million and $1.3 million, respectively, of which $1.4 million and $1.2 million were unamortized as of December 31, 2021, respectively. The Credit Agreement contains certain settlement provisions which, if deemed probable, would result in the recognition of an embedded feature. However, we do not believe such provisions are probable at this time. All amounts due under the Credit Agreement have been recorded in current liabilities on the consolidated balance sheet as of December 31, 2021 due to the considerations discussed in “Note 1. Description of Business and Summary of Significant Accounting Policies - Liquidity ” and the assessment that the events of default clause, which includes a material adverse effect provision under the Credit Agreement, is not within our control. We have not been notified of an event of default by DRI as of the date of the filing of this Annual Report on Form 10-K. As of December 31, 2021, the scheduled principal and interest payments (based on the interest rate of 10.00% as of December 31, 2021) as well as the back-end fee described above are as follows (in thousands): Principal Interest Back-end fee Total 2022 $ — $ 5,069 $ — $ 5,069 2023 — 5,069 — 5,069 2024 — 5,083 — 5,083 2025 — 5,069 — 5,069 2026 and thereafter 50,000 3,278 1,000 54,278 Total scheduled payments $ 50,000 $ 23,568 $ 1,000 $ 74,568 Less: debt discount and issuance costs (2,620) Current portion of long-term debt $ 47,380 Royalty Financing Agreement In connection with the Credit Agreement, we entered into a Purchase and Sale Agreement with DRI, or the Royalty Financing Agreement, pursuant to which we sold to DRI the right to receive certain royalty payments from us for a purchase price of up to $85.0 million in cash. Under the Royalty Financing Agreement, DRI is entitled to receive tiered, sales based royalties on net product sales of VONJO in the United States in an amount equal to: (i) 9.60% of annual net sales of VONJO in the United States for annual net sales up to $125 million, (ii) 4.50% of annual net sales of VONJO in the United States for annual net sales between $125 million and $175 million and (iii) 0.50% of annual net sales of VONJO in the United States for annual net sales between $175 million and $400 million. No royalty payments are payable on annual net sales of VONJO in the United States over $400 million. In March 2022, DRI funded the upfront purchase price of $60.0 million following FDA approval of VONJO in the United States and will be required to provide to us up to $25.0 million of additional funding if certain minimum pacritinib sales thresholds are met in 2023, or sooner. We are required to make payments of amounts owed to DRI each calendar quarter from and after the first commercial sale of the applicable product in the United States. The transactions contemplated by the Royalty Financing Agreement are referred to herein as the Royalty Sale. Under the Royalty Financing Agreement, we agreed to specified affirmative and negative covenants, including without limitation covenants regarding periodic reporting of information by us to DRI, obligations to use commercially reasonable efforts to commercialize VONJO in the United States and restrictions on the ability of the Company or any of its subsidiaries to incur certain indebtedness, which restrictions are eliminated after the earliest of: (i) the date on which the trailing twelve months’ of VONJO sales equals at least $200 million, (b) the date on which the Company’s market capitalization (determined on an as-converted basis) is at least $1.0 billion for 20 consecutive trading days or (c) DRI receiving royalty payments in an amount equal to 100% of their purchase price. The Royalty Financing Agreement also contains representations and warranties, other covenants, indemnification obligations, settlement and other provisions customary for transactions of this nature. We have evaluated the terms of the Royalty Financing Agreement and concluded that the features of the funding from DRI are similar to those of a debt instrument. Accordingly, we will account for the transaction as debt and the funding from DRI will be recorded as Royalty Financing Obligation on our consolidated balance sheet. The Royalty Financing Obligation will be amortized over the expected repayment term using an effective interest rate method. The effective interest rate will be calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate may vary during the term of the agreement depending on a number of factors, including the amount and timing of forecasted net revenues which affects the repayment timing and ultimate amount of repayment. We will evaluate the effective interest rate quarterly based on our current revenue forecasts utilizing the prospective method. |
Equity Transactions
Equity Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Equity Transactions | 8. Equity Transactions At-The-Market Equity Offering In January 2021, we entered into an Open Market Sale Agreement℠ with Jefferies LLC, or the Sale Agreement, to sell shares of our common stock having aggregate sales proceeds of up to $50.0 million, from time to time, through an “at the market” equity offering program under which Jefferies will act as sales agent. Under the Sale Agreement, we will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sale Agreement, Jefferies may sell the shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, including sales made directly on The Nasdaq Capital Market or on any other existing trading market for the common stock. Jefferies will use commercially reasonable efforts in conducting such sales activities consistent with its normal trading and sales practices, applicable state and federal laws, rules and regulations and the rules of The Nasdaq Stock Market LLC. We and Jefferies may each terminate the Sale Agreement at any time upon ten trading days’ prior notice. We may also sell shares to Jefferies acting as principal for Jefferies’ own account. The compensation to Jefferies for sales of our common stock will be an amount equal to 3% of the gross proceeds of any shares of our common stock sold under the Sale Agreement. We have no obligation to sell any shares under the Sale Agreement, and may at any time suspend solicitation and offers under the Sale Agreement. For the year ended December 31, 2021, we sold 0.9 million shares of our common stock for net proceeds of approximately $2.7 million under the Sale Agreement. Cash received from first quarter 2022 sales under the Sale Agreement as of the date of this Annual Report on Form 10-K was not material. Series X Preferred Stock In March 2020, we completed a rights offering whereby we issued a total of 15.7 million shares of our common stock and 4,429 shares of our Series X Preferred Stock, which shares of Series X Preferred Stock are convertible into 44.3 million shares of our common stock, for aggregate gross proceeds of approximately $60.0 million. See Form 10-K Part II, Item 8, “Notes to Consolidated Financial Statements, Note 8. Equity Transactions” of our Annual Report on Form 10-K for the year ended December 31, 2020 for additional information. During the year ended December 31, 2021, 635 shares of our Series X Preferred Stock were converted into 6.4 million shares of our common stock. There were 3,794 shares of our Series X Preferred Stock outstanding as of December 31, 2021. Public Offering of Common Stock and Series X 1 Preferred Stock In April 2021, we completed the public offering of our common stock and our Series X 1 Preferred Stock, or the Offering, whereby we issued 14,260,800 shares of our common stock, par value $0.001 per share, at a public offering price of $2.50 per share, and 600 shares of our Series X 1 Preferred Stock, par value $0.001 per share, at a public offering price of $25,000 per share. In addition, we granted the underwriters a 30-day option to purchase up to additional 2,139,120 shares of our common stock on the same terms and conditions, which was exercised in full in April 2021. The net proceeds to us from the Offering, after deducting underwriting discounts and offering expenses, were approximately $53.6 million. At the time of issuance of our Series X 1 Preferred Stock, the carrying amount of our Series X 1 Preferred Stock was initially classified as mezzanine equity in the consolidated balance sheet since we did not have an adequate number of shares of authorized common stock to satisfy the number of required shares under the conversion option of our Series X 1 Preferred Stock. In June 2021, our stockholders approved an increase in the number of shares of authorized common stock, and as such, we can now control settlement of the conversion option's exercise by delivering shares. Accordingly, the carrying amount of our Series X 1 Preferred Stock was reclassified to permanent equity in June 2021. BVF Partners L.P., or BVF, an existing stockholder of the Company, was one of the investors in the Offering. In connection with the Offering, BVF purchased 2.0 million shares of our common stock and 600 shares of our Series X 1 Preferred Stock. As of December 31, 2021 and 2020, BVF beneficially owned approximately 8.8% and 9.1%, respectively, of our outstanding common stock. Matthew D. Perry, a member of our Board, is the President of BVF and portfolio manager for the underlying funds managed by the firm. No shares of our Series X 1 Preferred Stock were converted into our common stock during the year ended December 31, 2021. There were 600 shares of our Series X 1 Preferred Stock outstanding as of December 31, 2021. Each share of Series X 1 Preferred Stock is convertible into 10,000 shares of our common stock at a conversion price of $2.50 per share of common stock, at the option of the holder at any time, subject to certain limitations, including that a holder of Series X 1 Preferred Stock is prohibited from converting Series X 1 Preferred Stock into common stock if, as a result of such conversion, such holder, together with its affiliates, would own more than 9.99% of the total number of shares of our common stock issued and outstanding immediately after giving effect to such conversion. Shares of Series X 1 Preferred Stock generally have no voting rights, except as otherwise expressly provided in the Certificate of Designation of Preferences, Rights and Limitations of Series X 1 Convertible Preferred Stock, or Certificate of Designation, or as otherwise required by law. However, as long as any shares of Series X 1 Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of Series X 1 Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series X 1 Preferred Stock or alter or amend this Certificate of Designation, amend or repeal any provision of, or add any provision to, the Certificate of Incorporation or bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, if such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series X 1 Preferred Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Certificate of Incorporation or by merger, consolidation or otherwise, (ii) issue further shares of Series X 1 Preferred Stock or increase or decrease (other than by conversion) the number of authorized shares of Series X 1 Preferred Stock, or (iii) enter into any agreement with respect to any of the foregoing. In the event of our liquidation, dissolution or winding up, holders of Series X 1 Preferred Stock will participate pari passu with any distribution of proceeds to holders of our common stock. Holders of Series X 1 Preferred Stock are entitled to receive dividends on shares of Series X 1 Preferred Stock equal (on an as-converted to common stock basis, without regard to the Beneficial Ownership Limitation (as defined in the Certificate of Designation)) to and in the same form as dividends actually paid on shares of common stock, plus an additional amount equal to any dividends declared but unpaid on such shares, before any payments shall be made or any assets distributed to holders of any class of Junior Securities (as defined in the Certificate of Designation). Common Stock Authorized In June 2020, the Company's certificate of incorporation was amended to increase the total number of authorized shares of common stock from 131.5 million to 166.5 million. In June 2021, the Company's certificate of incorporation was amended to increase the total number of authorized shares of common stock from 166.5 million to 266.5 million. Common Stock Reserved As of December 31, 2021, we had 266.5 million authorized shares of common stock, of which 99.8 million shares were issued and outstanding, and 88.2 million shares were available for future issuances. The remaining authorized shares were reserved as follows (in thousands): Equity incentive plans 21,738 Option agreement with Adam R. Craig per Nasdaq Listing Rule 5635(c)(4) 1,120 New hire stock options granted per Nasdaq Listing Rule 5635(c)(4) 2,382 Employee stock purchase plan 819 Convertible preferred stock 52,323 Common stock purchase warrants 169 Total common stock reserved 78,551 Warrants |
Collaboration, Licensing and Mi
Collaboration, Licensing and Milestone Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Collaborations [Abstract] | |
Collaboration, Licensing and Milestone Agreements | 9. Collaboration, Licensing and Milestone Agreements Baxalta In November 2013, we entered into the Pacritinib License Agreement with Baxter for the development and commercialization of pacritinib for use in oncology and potentially additional therapeutic areas. Baxter assigned its rights and obligations under the Pacritinib License Agreement to Baxalta. Under the Pacritinib License Agreement, we granted to Baxter an exclusive, worldwide (subject to our certain co-promotion rights in the United States), royalty-bearing, non-transferable, and (under certain circumstances outside of the United States) sub-licensable license to our know-how and patents relating to pacritinib. In October 2016, we entered into the Asset Return and Termination Agreement, or the Baxalta Termination Agreement, with Baxalta, pursuant to which the Pacritinib License Agreement was terminated in its entirety (other than with respect to certain customary provisions that survive termination, including those pertaining to confidentiality and indemnification). The Pacritinib License Agreement has no further force or effect, and all rights and obligations of the Company and Baxalta under the Pacritinib License Agreement were terminated. Pursuant to the Baxalta Termination Agreement, we are required to make a milestone payment to Takeda in the amount of approximately $10.3 million, upon the first regulatory approval or any pricing and reimbursement approvals of a product containing pacritinib. Baxalta was acquired by Shire plc in 2016, and Shire plc was subsequently acquired by Takeda in 2019. Subsequent to FDA approval of VONJO in February 2022, the $10.3 million milestone payment has become payable to Takeda. S*BIO Pte Ltd. We acquired the compounds SB1518 (which is referred to as “pacritinib”) and SB1578, which inhibit JAK2 and FLT3, from S*BIO Pte Ltd., or S*BIO, in May 2012. Under our agreement with S*BIO, we are required to make milestone payments to S*BIO up to an aggregate amount of $132.5 million if certain United States, EU and Japanese regulatory approvals are obtained or if certain worldwide net sales thresholds are met in connection with any pharmaceutical product containing or comprising any compound that we acquired from S*BIO for use for specific diseases, infections or other conditions. In addition, S*BIO will also be entitled to receive royalty payments from us at incremental rates in the low single-digits based on certain worldwide net sales thresholds on a product-by-product and country-by-country basis. Subsequent to FDA approval of VONJO in February 2022, a $25.0 million milestone payment has become payable to S*BIO. At our election, we may pay up to 50% of any milestone payments to S*BIO through the issuance of shares of our common stock or shares of our preferred stock automatically convertible into our common stock. Teva Pursuant to an acquisition agreement entered into with Cephalon, Inc., or Cephalon, in June 2005, we have the right to receive up to $100.0 million in payments upon achievement of specified sales and development milestones related to TRISENOX. Cephalon was subsequently acquired by Teva Pharmaceutical Industries Ltd., or Teva. As of December 31, 2021, we earned $60.0 million in such potential milestone payments as a result of Teva having achieved certain milestones. We did not earn any milestone revenues during the years ended December 31, 2021 and 2020. The achievement of the remaining milestones is uncertain at this time. Other Agreements We have several agreements with contract research organizations, third-party manufacturers and distributors which have durations of greater than one year for the development and distribution of certain of our compounds. |
Equity-Based Compensation
Equity-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Equity-Based Compensation | 10. Equity-Based Compensation All of equity-based compensation expense recognized during the years ended December 31, 2021 and 2020 was related to stock options. The following table summarizes equity-based compensation expense for the years ended December 31, 2021 and 2020, which was allocated as follows (in thousands): 2021 2020 Research and development $ 758 $ 522 Selling, general and administrative 3,985 3,795 Total equity-based compensation expense $ 4,743 $ 4,317 Equity-based compensation had a $4.7 million and $4.3 million effect on net loss for the years ended December 31, 2021 and 2020, respectively. It had no effect on cash flows from operating activities for the periods presented. As of December 31, 2021, unrecognized compensation cost related to unvested stock options amounted to $9.0 million, which will be recognized over the remaining weighted-average requisite service period of 2.03 years. For the years ended December 31, 2021 and 2020, no tax benefits were attributed to equity-based compensation expense because a valuation allowance was maintained for all net deferred tax assets. Stock Plans In May 2017, the Company's 2017 Equity Incentive Plan, or the 2017 Plan, was approved by the Company's shareholders, and no additional awards will be granted under the 2015 Equity Incentive Plan, or the 2015 Plan. The Company's 2007 Employee Stock Purchase Plan, as amended and restated in August 2009, September 2015 and June 2021, or the Purchase Plan, was amended in June 2021 to increase the maximum number of shares of the Company’s common stock authorized for issuance by 0.8 million shares. Refer to Employee Stock Purchase Plan below for further details. Pursuant to the 2017 Plan, we may grant the following types of incentive awards: (1) stock options, including incentive stock options and non-qualified stock options, (2) stock appreciation rights, (3) restricted stock, (4) restricted stock units and (5) cash awards. The 2017 Plan is administered by the Compensation Committee of our Board, which has the discretion to determine the employees and consultants who shall be granted incentive awards. The Board retained sole authority under the 2017 Plan with respect to non-employee directors’ awards, although the Compensation Committee has authority under its charter to make recommendations to the Board concerning such awards. Options expire 10 years from the date of grant, subject to the recipients' continued service to the Company. As of December 31, 2021, 24.3 million shares were authorized for issuance under equity incentive plans, of which 4.5 million shares of common stock were available for future grants under the 2017 Plan. Inducement Grants Outside of Stock Plans In March 2017, Dr. Adam R. Craig, our President and CEO, was granted stock options to purchase 1.2 million shares of our common stock at an exercise price of $4.24 per share. The stock options have a maximum term of ten years and vest in six equal semi-annual installments over the three-year period beginning March 20, 2017, subject to his continued employment through the applicable vesting dates and acceleration under certain circumstances. The stock options were granted in connection with his entering into employment with the Company as President and CEO. A portion of the stock options covering 80,000 shares were granted under the 2015 Plan. The balance of such stock options was granted outside of stock plans in accordance with Nasdaq Listing Rule 5635(c)(4). All the options remained outstanding as of December 31, 2021. As of December 31, 2021, inducement stock options to purchase an aggregate of 2.4 million shares of our common stock at a weighted average exercise price of $2.79 were issued and outstanding. The stock options were granted to our newly-hired employees as an inducement award to each employee entering into employment with the Company. The stock options were granted outside of stock plans in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have a maximum term of ten years and vest in equal annual installments over a four-year period, subject to the employee's continued employment through the applicable vesting dates. Stock Options Fair value for stock options was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions: Year Ended December 31, 2021 2020 Risk-free interest rate 0.8 % 0.5 % Expected dividend yield None None Expected life (in years) 5.2 4.6 Volatility 101 % 88 % The risk-free interest rate used in the Black-Scholes valuation method is based on the implied yield currently available for U.S. Treasury securities at maturity with an equivalent term. We have not declared or paid dividends on our common stock and do not currently expect to do so in the future. The expected term of options represents the period that our options are expected to be outstanding and was determined based on historical weighted average holding periods and projected holding periods for the remaining unexercised options. Consideration was given to the contractual terms of our options, vesting schedules and expectations of future employee behavior. Expected volatility is based on both historical and implied volatilities of CTI BioPharma Corp. and our selected peer group of comparable companies within the industry. Our stock price volatility and option lives, both of which impact the fair value of options calculated under the Black-Scholes methodology and, ultimately, the expense that will be recognized over the life of the option, involve management’s best estimates. As we recognize compensation expense for only the portion of options expected to vest, we apply estimated forfeiture rates that we derive from historical employee termination behavior. If the actual number of forfeitures differs from our estimates, adjustments to compensation expense may be required in future periods. The following table summarizes stock option activity during the year ended December 31, 2021: Options Weighted Weighted Aggregate Outstanding at December 31, 2020 (8,099,000 exercisable) 15,596,000 $ 2.09 Granted 5,773,000 $ 3.04 Exercised (143,000) $ 0.97 $ 200 Forfeited (194,000) $ 2.72 Cancelled and expired (341,000) $ 4.90 Outstanding at December 31, 2021 (11,776,000 exercisable) 20,691,000 $ 2.31 7.7 $ 15,336 Vested or expected to vest at December 31, 2021 19,781,000 $ 2.29 7.6 $ 15,175 Exercisable at December 31, 2021 11,776,000 $ 2.39 6.9 $ 9,781 The weighted average exercise price of options exercisable at December 31, 2021 and 2020 was $2.39 and $3.01, respectively. The weighted average grant-date fair value of options granted during 2021 and 2020 was $2.07 and $0.76 per option, respectively. Employee Stock Purchase Plan Under the Purchase Plan, eligible employees may purchase a limited number of shares of our common stock at 85% of the lower of the subscription date fair market value and the purchase date fair market value. There are two six-month offerings per year. Under the Purchase Plan, we issued approximately 0.1 million shares of our common stock to employees during the year ended December 31, 2021. There are 1.0 million shares of common stock authorized under the Purchase Plan and approximately 0.8 million shares are reserved for future purchases as of December 31, 2021. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 11. Employee Benefit PlansOur employees participate in the CTI BioPharma Corp. 401(k) Plan whereby eligible employees may defer up to 80% of their compensation, up to the annual maximum allowed by the Internal Revenue Service. We may make discretionary matching contributions based on certain plan provisions. We recorded $0.3 million and $0.1 million related to discretionary matching contributions for the years ended December 31, 2021 and 2020, respectively. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 12. Net Loss Per Share Basic net loss per share is calculated based on net loss divided by the weighted average number of shares outstanding for the period. The calculation of diluted net loss per share excludes the potential conversion of all dilutive convertible securities, such as convertible debt and convertible preferred stock, and the potential exercise or vesting of other dilutive securities, such as options, warrants and restricted stock, as their inclusion would have an anti-dilutive effect. Accordingly, diluted net loss per share is the same as basic net loss per share . The computation of net loss per share is as follows (in thousands, except per share amounts): Year Ended December 31, 2021 2020 Net loss $ (97,908) $ (52,451) Basic and diluted: Weighted average shares outstanding 90,117 71,146 Less: weighted average restricted shares outstanding — (5) Shares used in calculation of basic and diluted net loss per common share 90,117 71,141 Net loss per common share: Basic and diluted $ (1.09) $ (0.74) Common shares underlying equity awards, warrants and convertible preferred stock aggregating 74.5 million shares and 56.9 million shares prior to the application of the treasury stock method for the years ended December 31, 2021 and 2020, respectively, have been excluded from the calculation of diluted net loss per share because they were anti-dilutive. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies Commitments See “Note 6. Leases” and “Note 7. Debt Financing Arrangements” for scheduled lease and debt payments. In addition, certain of our licensing agreements obligate us to make payments upon achievement of milestones and pay a royalty on net sales of products utilizing licensed compounds. See “Note 9. Collaboration, Licensing and Milestone Agreements” for further details. Purchase commitments relating to clinical trial contracts, manufacturing supply, insurance and other obligations also arise in the ordinary course of business. We anticipate the timing of payments under these contracts to range from less than one year to more than three years. Contingencies In April 2009, December 2009 and June 2010, the Italian Tax Authority, or the ITA, issued notices of assessment to CTI - Sede Secondaria, or CTI (Europe), based on the ITA’s audit of CTI (Europe)’s value added tax, or VAT, returns for the years 2003, 2005, 2006 and 2007, or, collectively, the VAT Assessments. The ITA audits concluded that CTI (Europe) did not collect and remit VAT on certain invoices issued to non-Italian clients for services performed by CTI (Europe). The assessments, including interest and penalties, for the years 2003, 2006 and 2007 are €0.7 million, €2.8 million and €0.9 million, respectively. We believe that the services invoiced were non-VAT taxable consultancy services and that the VAT returns are correct as originally filed. We have appealed all the assessments and are defending ourselves against the assessments both on procedural grounds and on the merits of the cases, although we can make no assurances regarding the ultimate outcome of these cases. Following is a summary of the status of the legal proceedings surrounding each respective VAT year return at issue: 2003 VAT Assessment . In June 2013, the Regional Tax Court issued decision no. 119/50/13 in regards to the 2003 VAT Assessment, which accepted the October 2012 appeal of the ITA and reversed a previous decision of the Provincial Tax Court. In January 2014, we appealed such decision to the Italian Supreme Court both on procedural grounds and on the merits of the case. In March 2014, we paid a deposit in respect of the 2013 VAT matter of €0.4 million (or $0.6 million upon conversion from euros as of the date of payment), following the ITA's request for such payment. 2005 VAT Assessment. In January 2018, the Italian Supreme Court issued decision No. 02250/2018 which (i) rejected the April 2013 appeal of the ITA, (ii) confirmed the October 2012 decision of the Regional Tax Court (127/31/2012), which fully accepted the merits of our earlier appeal and confirmed that no penalties could be imposed against us, and (iii) due to the novelty of the arguments at stake, compensated the legal expenses incurred by the parties. The ITA may not use any ordinary means of appeal against the Italian Supreme Court decision, and we have applied for a refund based on the guidance from the ITA. 2006 and 2007 VAT Assessments. In November 2013, the ITA appealed to the Italian Supreme Court an April 2013 decision of the Regional Tax Court (57/35/13), that fully rejected the merits of an earlier ITA appeal, declared that no penalties could be imposed against us and found the ITA liable to pay us approximately €12,000, as a partial refund of legal expenses we incurred. No hearing dates have been fixed yet for either the 2003 VAT Assessment or consolidated 2006 and 2007 VAT Assessment cases. If the final decision of the Italian Supreme Court is unfavorable to us, or if, in the interim, the ITA were to make a demand for payment and we were to be unsuccessful in suspending collection efforts, we may be requested to pay the ITA an amount up to €4.4 million, or approximately $4.9 million converted using the currency exchange rate as of December 31, 2021, including interest and penalties for the period lapsed between the date in which the assessments were issued and the date of effective payment. We have not recorded this contingent liability in the consolidated financial statements as we do not believe the potential payment to the ITA is probable at this time. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes We file income tax returns in the United States and Germany. A substantial part of our operations takes place in the State of Washington, which does not impose an income tax as that term is defined in ASC 740, Accounting for Income Taxes . As such, our state income tax expense or benefit, if recognized, would be immaterial to our operations. We are not currently under examination by an income tax authority, nor have we been notified that an examination is contemplated. Loss before income taxes is attributable to the following tax jurisdictions (in thousands): Year ended December 31, 2021 2020 United States $ (97,908) $ (52,451) Foreign — — Net loss before income taxes $ (97,908) $ (52,451) The reconciliation between the income tax rate and our effective tax rate as of December 31 is as follows: 2021 2020 Federal income tax rate 21 % 21 % Research and development tax credits 5 4 Non-deductible compensation (1) (2) Valuation allowance (24) 20 Receivable impairment — (2) Expired tax attribute carryforwards / Section 382 limitation — (29) Loss on subsidiary liquidation — (14) Unrecognized tax benefits (1) 2 Net effective tax rate — % — % The principal components of our deferred tax assets and liabilities as of December 31 were as follows (in thousands): 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 40,061 $ 22,756 Capitalized research and development 35,910 33,280 Research and development tax credit carryforwards 5,386 1,779 Equity-based compensation 3,337 3,176 Intangible assets 7,026 7,251 Depreciation and amortization 785 699 Lease liability 670 629 Other deferred tax assets 231 312 Total deferred tax assets 93,406 69,882 Less: valuation allowance (92,395) (69,085) 1,011 797 Deferred tax liabilities: Right-of-use asset (656) (451) Deductions for tax in excess of financial statements (355) (346) Total deferred tax liabilities (1,011) (797) Net deferred tax assets $ — $ — As of December 31, 2021 and 2020, we had U.S. federal net operating loss carryforwards, or the NOL, of approximately $182.7 million and $99.9 million respectively, which are available to reduce future taxable income. The Tax Cuts and Jobs Act enacted in December 2017 altered the carryforward period for federal net operating losses and as a result, all net operating losses generated in 2018 and forward have an indefinite life. Of the net operating losses reported, we have accumulated $170.7 million with an indefinite life as of December 31, 2021. We have accumulated state tax losses of approximately $15.0 million and $12.3 million as of December 31, 2021 and 2020, respectively. We also had U.S. federal tax credits of $5.4 million and $1.8 million as of December 31, 2021 and 2020, respectively, which may be used to offset future tax liabilities. The NOL and tax credit carryforwards, some of which expired in 2021, are subject to annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, or the IRC, of 1986, as amended. This limits the amount of tax attributes that can be utilized annually to offset future taxable income or future tax liabilities. We have undertaken a formal IRC Section 382 study and the attributes disclosed in this footnote reflect the conclusion of that study. However, subsequent ownership changes may further affect the limitation in future years. We maintain a full valuation allowance on our net deferred tax assets. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In our valuation, we considered our cumulative loss in recent years and forecasted losses in the near term as significant negative evidence. Based upon a review of the four sources of income identified within ASC 740, we determined that the negative evidence outweighed the positive evidence and that a full valuation allowance on our net deferred tax assets will be maintained. We will continue to assess the realizability of our deferred tax assets going forward and will adjust the valuation allowance as needed. Our valuation allowance increased by $23.3 million during the year ended December 31, 2021 primarily due to the increase in net operating loss carryforwards and tax credit carryforwards. We follow the provisions in ASC 740 and the guidance related to accounting for uncertainty in income taxes. We determine our uncertain tax positions based on a determination of whether and how much of a tax benefit taken by us in our tax filings or positions is more likely than not to be sustained upon examination by the relevant income tax authorities. We are subject to U.S. federal and state and U.K. income taxes with varying statutes of limitations. Tax years from 2002 forward remain open to examination due to the carryover of net operating losses or tax credits. Our policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. The total balance of unrecognized tax benefits as of December 31 is as follows (in thousands): 2021 2020 Balance at beginning of period $ 390 $ 1,268 Gross increases to tax positions in prior periods — — Gross decreases to tax positions in current periods — (1,268) Gross increases to tax positions in current periods 819 390 Balance at end of period $ 1,209 $ 390 |
Description of Business and S_2
Description of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Description of Business | CTI BioPharma Corp. and our subsidiaries, also referred to in this Annual Report on Form 10-K as “we,” “us,” “our,” the “Company” and “CTI,” is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers where there is a significant unmet medical need. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with partners. We have one commercially approved product, VONJO™ (pacritinib), which received accelerated approval in February 2022 from the the FDA in the United States, for the treatment of adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 x 10 9 /L. We commercially launched VONJO in the first quarter of 2022. We operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products requires approval from, and is subject to, ongoing oversight by the FDA in the United States, the EMA in the EU, and comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve the expenditure of substantial resources. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of our majority-owned subsidiary, Aequus Biopharma, Inc., or Aequus, until its dissolution in June 2020. We had an approximately 60% interest in Aequus; the remaining interest not held by CTI was reported as noncontrolling interest |
Liquidity | Liquidity The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the consolidated financial statements are issued. Our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosures of loss contingencies in the consolidated financial statements and accompanying notes. Estimates are used for, but not limited to, clinical accruals, income taxes, commitments and contingencies, and equity-based compensation forfeiture rates. Given the global economic climate and additional or unforeseen effects from the ongoing COVID-19 pandemic, these estimates are becoming more challenging, and actual results could differ materially from those estimates. |
Segment Information | Segment Information We view our operations and manage our business in a single operating segment focused on the business of acquiring, developing and commercializing novel targeted therapies for blood-related cancers. All of our tangible assets are held in the United States. |
Certain Risks, Uncertainties and Concentrations | Certain Risks, Uncertainties and Concentrations Cash, cash equivalents and marketable securities are financial instruments which potentially subject us to concentrations of credit risk. We have not experienced any significant credit losses on cash, cash equivalents, or marketable securities to date. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. We source our drug products for commercial operations and clinical trials from a concentrated group of third-party contractors. If we are unable to obtain sufficient quantities of source materials, manufacture or distribute our products to customers from existing suppliers and service providers, or obtain the materials or services from other suppliers or manufacturers, certain sales and research and development activities may be delayed. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest: • Level 1—Valuations based on unadjusted quoted prices for identical assets and liabilities in active markets. • Level 2—Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Valuations based on unobservable inputs that are supported by little or no market activity, reflecting our own assumptions. These valuations require significant judgment or estimation. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid instruments with original maturities of three months or less at the time acquired to be cash equivalents. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. |
Italian Value Added Tax | Italian Value Added Tax As disclosed in “Note 13. Commitments and Contingencies , ” the Italian Tax Authority, or the ITA, assessed us for |
Leases | Leases Under ASC 842 - Leases , we determine if an arrangement is a lease at inception. We recognize a right-of-use asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as operating or finance at lease commencement, which will affect the pattern and classification of expense recognition in our consolidated statements of operations. Right-of-use assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As our leases do not provide a readily determinable implicit rate of return, we derive the present value of lease payments using our incremental borrowing rate, which is the rate of interest that we would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Lease expense for operating leases is recognized on a straight-line basis over the lease term as part of Research and development expenses and Selling, general and administrative expenses in our consolidated statements of operations. Right-of-use assets are included in Other assets , and the current portion of lease liabilities and the non-current portion of lease liabilities are included in Other current liabilities and Other liabilities |
Property and Equipment | Property and Equipment Property and equipment are carried at cost, less accumulated depreciation and amortization. Depreciation commences at the time assets are placed in service. We calculate depreciation using the straight-line method over the estimated useful lives of the assets, ranging from three |
Impairment of Long-lived Assets | Impairment of Long-lived Assets We review our long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. If an impairment is indicated, the asset is written down to its estimated fair value. |
Contingencies | ContingenciesWe record liabilities associated with loss contingencies to the extent that we conclude that the occurrence of the contingency is probable and that the amount of the related loss is reasonably estimable. We record income from gain contingencies only upon the realization of assets resulting from the favorable outcome of the contingent event. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred in accordance with ASC 730, Research and Development . Research and development expenses include related salaries and benefits, clinical trial and related manufacturing costs, contract and other outside service fees, and facilities and overhead costs related to our research and development efforts. Research and development expenses also consist of costs incurred for proprietary and collaboration research and development and include activities such as product registries and investigator-sponsored trials. In instances where we enter into agreements with third parties for research and development activities, we may prepay fees for services at the initiation of the contract. We record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Other types of arrangements with third parties may be fixed fee or fee for service, and may include monthly payments or payments upon completion of milestones or receipt of deliverables. We expense upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. |
Equity-Based Compensation Expense | Equity-Based Compensation Expense Equity-based compensation expense for all equity-based payment awards made to employees and directors is measured based on the grant-date fair value estimated in accordance with U.S. GAAP. We recognize equity-based compensation using the straight-line, single-award method based on the value of the portion of equity-based payment awards that is ultimately expected to vest. We apply estimated forfeiture rates at the time of grant and make revisions, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For performance-based awards that do not include market-based conditions, we record equity-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. |
Income Taxes | Income TaxesThe provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, and for operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the currently enacted tax rates in effect for the years in which those tax assets and liabilities are expected to be realized or settled. We provide a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized. |
Net Loss per Share | Net Loss per Share Basic net loss per common share is calculated based on net loss divided by the weighted average number of shares outstanding for the period. The calculation of diluted net loss per common share excludes the potential conversion of all dilutive convertible securities, such as convertible preferred stock, using the if-converted method, and the potential exercise or vesting of other dilutive securities, such as options, warrants and restricted stock, using the treasury stock method, as their inclusion would have an anti-dilutive effect. |
Recent Accounting Standards | Recently Adopted Accounting Standards In August 2020, the FASB issued new accounting guidance for convertible instruments which eliminates two of the three models in ASC 470-20 that require separate accounting for embedded conversion features. Separate accounting is still required in certain cases. For smaller reporting companies, the guidance is effective for fiscal years beginning after December 15, 2023, including interim periods therein. Early adoption is permitted in fiscal years beginning after December 15, 2020. We early adopted this guidance as of January 1, 2021. In April 2021, as discussed in “Note 8. Equity Transactions,” we completed the public offering of our common stock and our Series X 1 Preferred Stock. No beneficial conversion feature was recognized on Series X 1 Preferred Stock upon issuance. Recently Issued Accounting Standards In March 2020, the FASB issued new accounting guidance to provide temporary optional expedients to ease the potential burden in accounting for reference rate reform. The guidance includes an optional expedient that simplifies accounting for contract modifications to loans receivable and debt, by prospectively adjusting the effective interest rate. The accounting guidance is effective as of January 7, 2021 through December 31, 2022. As discussed in “Note 7. Debt Financing Arrangements,” in August 2021, we entered into a Credit Agreement, which has an interest rate referenced to the London Interbank Offered Rate, or LIBOR. We plan to elect the optional expedient for our credit facility by prospectively adjusting the effective interest rate if the cessation of the LIBOR occurs. We do not expect the adoption of this guidance to have a material impact on our consolidated financial statements. |
Reclassifications | Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Description of Business and S_3
Description of Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Cash and Cash Equivalents, Measured at Fair Value on a Recurring Basis | The following table summarizes, by major security type, our cash, cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): December 31, 2021 December 31, 2020 Cost or Amortized Cost Gross Unrealized Gains / (Losses) Total Estimated Fair Value Total Estimated Cash $ 137 $ — $ 137 $ 385 Level 1 securities: Money market funds 65,309 — 65,309 40,009 Level 2 securities: Corporate debt securities — — — 12,057 Total cash, cash equivalents and short-term investments $ 65,446 $ — $ 65,446 $ 52,451 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consisted of the following as of December 31, 2021 and 2020 (in thousands): 2021 2020 Furniture and office equipment $ 597 $ 663 Leasehold improvements 5,140 5,140 5,737 5,803 Less: accumulated depreciation and amortization (5,561) (5,084) Property and equipment, net $ 176 $ 719 |
Other Assets (Tables)
Other Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Other Assets | Other assets consisted of the following as of December 31, 2021 and 2020 (in thousands): 2021 2020 Right-of-use assets $ 3,109 $ 2,149 Clinical trial deposits 770 770 Refundable security deposit — 194 Other — 84 Total other assets $ 3,879 $ 3,197 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following as of December 31, 2021 and 2020 (in thousands): 2021 2020 Clinical trial expenses $ 4,053 $ 3,512 Employee compensation and related expenses 4,783 2,792 Commercial expenses 3,075 — Manufacturing expenses 288 238 Other 521 649 Total accrued expenses $ 12,720 $ 7,191 |
Other Current Liabilities (Tabl
Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Other Liabilities Disclosure [Abstract] | |
Components of Other Liabilities | Other current liabilities consisted of the following as of December 31, 2021 and 2020 (in thousands): 2021 2020 Operating lease liabilities - current $ 1,160 $ 2,194 End-of-facility lender fee (1) 1,000 1,440 Other current obligations 500 121 Total other current liabilities $ 2,660 $ 3,755 (1) The end-of-facility lender fee as of December 31, 2021 represents an amount payable to Drug Royalty III LP 2, or DRI, upon repayment of our secured term loan under the Credit Agreement with DRI. The end-of-facility lender fee as of December 31, 2020 represents an amount payable to Silicon Valley Bank upon repayment of our secured term loan, which was repaid in August 2021. See “Note 7. Debt Financing Arrangements” for additional information. |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Components of Lease Expenses and Supplemental Information | The components of lease expense, which were included in our consolidated statements of operations, were as follows (in thousands): Year Ended December 31, 2021 2020 Operating lease expense $ 1,586 $ 1,653 Variable lease expense 183 230 Sublease income (1,254) (1,247) Total lease expense, net $ 515 $ 636 December 31, 2021 Supplemental cash flow information Cash paid for amounts included in the measurement of lease liabilities $ 2,435 Right-of-use assets obtained in exchange for operating lease liabilities due to lease amendment $ 2,384 Weighted-average remaining lease term of operating leases (years) 3.33 Weighted-average discount rate of operating leases 11.6 % |
Balance Sheet Classification of Operating Lease Components | The balance sheet classification of operating lease right-of-use assets and operating lease liabilities were as follows (in thousands): December 31, 2021 Right-of-use assets (included in Other Assets ) $ 3,109 Operating lease liabilities, current (included in Other current liabilities ) $ 1,160 Operating lease liabilities, non-current (included in Other liabilities, less current portion ) 2,016 Total lease liabilities $ 3,176 |
Schedule of Future Minimum Operating Lease Payments and Receivables | As of December 31, 2021, the maturities of operating lease liabilities were as follows (in thousands): Operating Sublease Lease Payments Rental Receipts Net 2022 $ 1,450 $ (499) $ 951 2023 976 — 976 2024 1,002 — 1,002 2025 337 — 337 Thereafter — — — Total payments 3,765 $ (499) $ 3,266 Less imputed interest (589) Total lease liabilities $ 3,176 |
Schedule of Future Minimum Operating Lease Payments and Receivables | As of December 31, 2021, the maturities of operating lease liabilities were as follows (in thousands): Operating Sublease Lease Payments Rental Receipts Net 2022 $ 1,450 $ (499) $ 951 2023 976 — 976 2024 1,002 — 1,002 2025 337 — 337 Thereafter — — — Total payments 3,765 $ (499) $ 3,266 Less imputed interest (589) Total lease liabilities $ 3,176 |
Debt Financing Agreements (Tabl
Debt Financing Agreements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Principal and Interest Payments of Debt | As of December 31, 2021, the scheduled principal and interest payments (based on the interest rate of 10.00% as of December 31, 2021) as well as the back-end fee described above are as follows (in thousands): Principal Interest Back-end fee Total 2022 $ — $ 5,069 $ — $ 5,069 2023 — 5,069 — 5,069 2024 — 5,083 — 5,083 2025 — 5,069 — 5,069 2026 and thereafter 50,000 3,278 1,000 54,278 Total scheduled payments $ 50,000 $ 23,568 $ 1,000 $ 74,568 Less: debt discount and issuance costs (2,620) Current portion of long-term debt $ 47,380 |
Equity Transactions (Tables)
Equity Transactions (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Common Stock Reserved for Issuance | As of December 31, 2021, we had 266.5 million authorized shares of common stock, of which 99.8 million shares were issued and outstanding, and 88.2 million shares were available for future issuances. The remaining authorized shares were reserved as follows (in thousands): Equity incentive plans 21,738 Option agreement with Adam R. Craig per Nasdaq Listing Rule 5635(c)(4) 1,120 New hire stock options granted per Nasdaq Listing Rule 5635(c)(4) 2,382 Employee stock purchase plan 819 Convertible preferred stock 52,323 Common stock purchase warrants 169 Total common stock reserved 78,551 |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Share-Based Compensation Expense | The following table summarizes equity-based compensation expense for the years ended December 31, 2021 and 2020, which was allocated as follows (in thousands): 2021 2020 Research and development $ 758 $ 522 Selling, general and administrative 3,985 3,795 Total equity-based compensation expense $ 4,743 $ 4,317 |
Schedule of Black Scholes Stock Option Pricing Model Weighted Average Assumptions | Fair value for stock options was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions: Year Ended December 31, 2021 2020 Risk-free interest rate 0.8 % 0.5 % Expected dividend yield None None Expected life (in years) 5.2 4.6 Volatility 101 % 88 % |
Stock Option Activity for All Stock Plans | The following table summarizes stock option activity during the year ended December 31, 2021: Options Weighted Weighted Aggregate Outstanding at December 31, 2020 (8,099,000 exercisable) 15,596,000 $ 2.09 Granted 5,773,000 $ 3.04 Exercised (143,000) $ 0.97 $ 200 Forfeited (194,000) $ 2.72 Cancelled and expired (341,000) $ 4.90 Outstanding at December 31, 2021 (11,776,000 exercisable) 20,691,000 $ 2.31 7.7 $ 15,336 Vested or expected to vest at December 31, 2021 19,781,000 $ 2.29 7.6 $ 15,175 Exercisable at December 31, 2021 11,776,000 $ 2.39 6.9 $ 9,781 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Shares | The computation of net loss per share is as follows (in thousands, except per share amounts): Year Ended December 31, 2021 2020 Net loss $ (97,908) $ (52,451) Basic and diluted: Weighted average shares outstanding 90,117 71,146 Less: weighted average restricted shares outstanding — (5) Shares used in calculation of basic and diluted net loss per common share 90,117 71,141 Net loss per common share: Basic and diluted $ (1.09) $ (0.74) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes | Loss before income taxes is attributable to the following tax jurisdictions (in thousands): Year ended December 31, 2021 2020 United States $ (97,908) $ (52,451) Foreign — — Net loss before income taxes $ (97,908) $ (52,451) |
Reconciliation Between Effective Tax Rate and Income Tax Rate | The reconciliation between the income tax rate and our effective tax rate as of December 31 is as follows: 2021 2020 Federal income tax rate 21 % 21 % Research and development tax credits 5 4 Non-deductible compensation (1) (2) Valuation allowance (24) 20 Receivable impairment — (2) Expired tax attribute carryforwards / Section 382 limitation — (29) Loss on subsidiary liquidation — (14) Unrecognized tax benefits (1) 2 Net effective tax rate — % — % |
Significant Components of Deferred Tax Assets and Liabilities | The principal components of our deferred tax assets and liabilities as of December 31 were as follows (in thousands): 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 40,061 $ 22,756 Capitalized research and development 35,910 33,280 Research and development tax credit carryforwards 5,386 1,779 Equity-based compensation 3,337 3,176 Intangible assets 7,026 7,251 Depreciation and amortization 785 699 Lease liability 670 629 Other deferred tax assets 231 312 Total deferred tax assets 93,406 69,882 Less: valuation allowance (92,395) (69,085) 1,011 797 Deferred tax liabilities: Right-of-use asset (656) (451) Deductions for tax in excess of financial statements (355) (346) Total deferred tax liabilities (1,011) (797) Net deferred tax assets $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward | The total balance of unrecognized tax benefits as of December 31 is as follows (in thousands): 2021 2020 Balance at beginning of period $ 390 $ 1,268 Gross increases to tax positions in prior periods — — Gross decreases to tax positions in current periods — (1,268) Gross increases to tax positions in current periods 819 390 Balance at end of period $ 1,209 $ 390 |
Description of Business and S_4
Description of Business and Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands, € in Millions | 3 Months Ended | 12 Months Ended | |||
Mar. 17, 2022USD ($) | Dec. 31, 2021USD ($)product | Dec. 31, 2021EUR (€) | Dec. 31, 2020USD ($) | Jun. 30, 2020 | |
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Number Of Commercially Approved Products | product | 1 | ||||
Accumulated deficit | $ (2,425,915) | $ (2,328,007) | |||
Available cash and cash equivalents | 65,446 | $ 52,451 | |||
VAT potential payment | $ 4,900 | € 4.4 | |||
Royalty Financing Agreement | Notes Payable, Other Payables | Subsequent Event | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Proceeds from Issuance of Debt | $ 60,000 | ||||
Leasehold Improvements | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Property and equipment useful life | 10 years | ||||
Minimum | Assets Other Than Leasehold Improvements | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Property and equipment useful life | 3 years | ||||
Maximum | Assets Other Than Leasehold Improvements | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Property and equipment useful life | 5 years | ||||
Aequus Biopharma, Inc | Affiliated Entity | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Interest in majority-owned subsidiary | 60.00% |
Description of Business and S_5
Description of Business and Summary of Significant Accounting Policies - Cash and Cash Equivalents and Short-term Investments Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Abstract] | ||
Cash and cash equivalents | $ 137 | $ 385 |
Total cash, cash equivalents and short-term investments, amortized cost | 65,446 | |
Total cash, cash equivalents and short-term investments, gross unrealized losses | 0 | |
Total cash, cash equivalents and short-term investments | 65,446 | 52,451 |
Level 1 | Money market funds | ||
Debt Securities, Available-for-sale [Abstract] | ||
Cash and cash equivalents | 65,309 | 40,009 |
Level 2 | Corporate debt securities | ||
Debt Securities, Available-for-sale [Abstract] | ||
Cost or Amortized Cost | 0 | |
Gross Unrealized Gains / (Losses) | 0 | |
Total Estimated Fair Value | $ 0 | $ 12,057 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Line Items] | ||
Property and equipment, net | $ 5,737 | $ 5,803 |
Less: accumulated depreciation and amortization | (5,561) | (5,084) |
Property and equipment, net | 176 | 719 |
Depreciation expense | 526 | 532 |
Furniture and office equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, net | 597 | 663 |
Leasehold improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, net | $ 5,140 | $ 5,140 |
Other Assets (Details)
Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Right-of-use assets | $ 3,109 | $ 2,149 |
Clinical trial deposits | 770 | 770 |
Refundable security deposit | 0 | 194 |
Other | 0 | 84 |
Other assets | $ 3,879 | $ 3,197 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other assets | Other assets |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Clinical trial expenses | $ 4,053 | $ 3,512 |
Employee compensation and related expenses | 4,783 | 2,792 |
Commercial expenses | 3,075 | 0 |
Manufacturing expenses | 288 | 238 |
Other | 521 | 649 |
Accrued expenses | $ 12,720 | $ 7,191 |
Other Current Liabilities (Deta
Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Operating lease liabilities, current (included in Other current liabilities) | $ 1,160 | $ 2,194 |
Accrued Lender Fee, Current | 1,000 | 1,440 |
Other current obligations | 500 | 121 |
Total other current liabilities | $ 2,660 | $ 3,755 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Total other current liabilities | Total other current liabilities |
Leases - Additional Information
Leases - Additional Information (Detail) | 1 Months Ended | ||
Dec. 31, 2021USD ($)ft²Option | Jan. 31, 2012USD ($)ft²Option | Dec. 31, 2017USD ($)ft² | |
Leases [Abstract] | |||
Area of office spaces | ft² | 23,000 | 66,000 | 44,000 |
Lease term | 10 years | ||
Number of options to extend the term | Option | 1 | 2 | |
Extend option term | 5 years | 5 years | |
Allowance for tenant improvements | $ 50,000 | $ 3,900,000 | |
Sublease payments receivable within five months | $ 0 | ||
Lease extended term | 3 years | ||
Increase in right-of-use asset balance | $ 2,400,000 | ||
Increase in lease liability balance | $ 2,400,000 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases [Abstract] | ||
Operating lease expense | $ 1,586 | $ 1,653 |
Variable lease expense | 183 | 230 |
Sublease income | (1,254) | (1,247) |
Total lease expense, net | $ 515 | $ 636 |
Leases - Balance Sheet Classifi
Leases - Balance Sheet Classification of Operating Lease Components (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Right-of-use assets (included in Other Assets) | $ 3,109 | $ 2,149 |
Operating lease liabilities, current (included in Other current liabilities) | 1,160 | $ 2,194 |
Operating lease liabilities, non-current (included in Other liabilities, less current portion) | 2,016 | |
Total lease liabilities | $ 3,176 | |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other assets | Other assets |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | Other current liabilities |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities, Noncurrent |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments Under Noncancelable Operating Leases (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Operating Leases Future Minimum Payments | |
2022 | $ 1,450 |
2023 | 976 |
2024 | 1,002 |
2025 | 337 |
Thereafter | 0 |
Total payments | 3,765 |
Less imputed interest | (589) |
Total lease liabilities | 3,176 |
Sublease Rentals Future Payments Receivable | |
2022 | (499) |
2023 | 0 |
2024 | 0 |
2025 | 0 |
Thereafter | 0 |
Total payments | (499) |
Net, 2022 | 951 |
Net, 2023 | 976 |
Net, 2024 | 1,002 |
Net, 2025 | 337 |
Net, Thereafter | 0 |
Net, Total payments | $ 3,266 |
Leases - Supplemental Informati
Leases - Supplemental Information Relating to Operating Leases (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Leases [Abstract] | |
Cash paid for amounts included in the measurement of lease liabilities | $ 2,435 |
Right-of-use assets obtained in exchange for operating lease liabilities due to lease amendment | $ 2,384 |
Weighted-average remaining lease term of operating leases (years) | 3 years 3 months 29 days |
Weighted-average discount rate of operating leases | 11.60% |
Debt Financing Agreements - Sil
Debt Financing Agreements - Silicon Valley Bank (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | |||
Repayment of Silicon Valley Bank debt | $ 6,329 | $ 5,333 | |
Secured Debt | Loan and Security Agreement | Silicon Valley Bank | |||
Debt Instrument [Line Items] | |||
Repayment of Silicon Valley Bank debt | $ 1,300 | ||
Fee amount on term loan | 1,400 | ||
Prepayment premium | $ 40 | ||
Loss on debt extinguishment | $ 100 |
Debt Financing Agreements - Dru
Debt Financing Agreements - Drug Royalty III LP 2 Credit Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | |
Aug. 31, 2021 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | ||
Outstanding term loan principal balance | $ 50,000 | |
Drug Royalty III LP 2 Credit Agreement | Secured Debt | ||
Debt Instrument [Line Items] | ||
Principal amount | $ 50,000 | |
Exit fee | 2.00% | |
Commitment fee | 1.00% | |
Debt covenant, required cash on hand | $ 10,000 | |
Outstanding term loan principal balance | 50,000 | |
Debt discount | 1,500 | 1,400 |
Debt issuance costs | $ 1,300 | |
Debt issuance costs, unamortized | $ 1,200 | |
Drug Royalty III LP 2 Credit Agreement | Secured Debt | London Interbank Offered Rate (LIBOR) | ||
Debt Instrument [Line Items] | ||
Interest rate threshold | 1.75% | |
Interest rate above prime rate | 8.25% | |
Interest rate in event of default | 10.25% | |
Loan and Security Agreement | Secured Debt | Silicon Valley Bank | ||
Debt Instrument [Line Items] | ||
Interest rate | 10.00% |
Debt Financing Agreements - Pri
Debt Financing Agreements - Principal and Interest Payments of Debt (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Principal | |
Scheduled payments, Principal, 2022 | $ 0 |
Scheduled payments, Principal, 2023 | 0 |
Scheduled payments, Principal, 2024 | 0 |
Scheduled payments, Principal, 2025 | 0 |
Scheduled payments, Principal, 2026 and thereafter | 50,000 |
Outstanding term loan principal balance | 50,000 |
Less: debt discount and issuance costs | (2,620) |
Current portion of long-term debt | 47,380 |
Interest | |
Scheduled payments, Interest, 2022 | 5,069 |
Scheduled payments, Interest, 2023 | 5,069 |
Scheduled payments, Interest, 2024 | 5,083 |
Scheduled payments, Interest, 2025 | 5,069 |
Scheduled payments, Interest, 2026 and thereafter | 3,278 |
Total scheduled payments, Interest | 23,568 |
Back-end fee | |
Scheduled payments, Back-end fee, 2022 | 0 |
Scheduled payments, Back-end fee, 2023 | 0 |
Scheduled payments, Back-end fee, 2024 | 0 |
Scheduled payments, Back-end fee, 2025 | 0 |
Scheduled payments, Back-end fee, 2026 and thereafter | 1,000 |
Total scheduled payments, Back-end fee | 1,000 |
Total scheduled payments, 2022 | 5,069 |
Total scheduled payments, 2023 | 5,069 |
Total scheduled payments, 2024 | 5,083 |
Total scheduled payments, 2025 | 5,069 |
Total scheduled payments, 2026 and thereafter | 54,278 |
Total scheduled payments | $ 74,568 |
Debt Financing Agreement - Roya
Debt Financing Agreement - Royalty Financing Agreement (Details) $ in Thousands | 1 Months Ended | ||
Aug. 31, 2021USD ($)day | Mar. 17, 2022USD ($) | Dec. 31, 2021USD ($) | |
Debt Instrument [Line Items] | |||
Purchase price | $ 85,000 | ||
Upfront purchase price | $ 50,000 | ||
Market capitalization threshold required to eliminate negative covenant | $ 1,000,000 | ||
Market capitalization threshold required to eliminate negative covenant, consecutive trading days required | day | 20 | ||
Royalty payment threshold required to eliminate negative covenant | 100.00% | ||
Royalty Financing Agreement | Notes Payable, Other Payables | Subsequent Event | |||
Debt Instrument [Line Items] | |||
Upfront purchase price | $ 60,000 | ||
Royalty Financing Agreement | Line of Credit | |||
Debt Instrument [Line Items] | |||
Potential additional funding if certain sales thresholds met | $ 25,000 | ||
VONJO | |||
Debt Instrument [Line Items] | |||
Sales threshold required to eliminate negative covenant | $ 200,000 | ||
Tier One | VONJO | |||
Debt Instrument [Line Items] | |||
Annual net sales | 9.60% | ||
Annual net sales, lower limit | $ 125,000 | ||
Tier Two | VONJO | |||
Debt Instrument [Line Items] | |||
Annual net sales | 4.50% | ||
Annual net sales, lower limit | $ 125,000 | ||
Annual net sales, upper limit | $ 175,000 | ||
Tier Three | VONJO | |||
Debt Instrument [Line Items] | |||
Annual net sales | 0.50% | ||
Annual net sales, lower limit | $ 175,000 | ||
Annual net sales, upper limit | $ 400,000 | ||
Tier Four | VONJO | |||
Debt Instrument [Line Items] | |||
Annual net sales | 0.00% | ||
Annual net sales, lower limit | $ 400,000 |
Equity Transactions - At-The-Ma
Equity Transactions - At-The-Market Equity Offering (Details) - At-The Market Equity Offering - USD ($) shares in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended |
Jan. 31, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | |
Class of Stock [Line Items] | |||
Gross proceeds from offering | $ 2,700,000 | ||
Subsequent Event | |||
Class of Stock [Line Items] | |||
Gross proceeds from offering | $ 0 | ||
Common Stock | |||
Class of Stock [Line Items] | |||
Expected proceeds from common stock offering, net of issuance costs | $ 50,000,000 | ||
Percent of gross proceeds, underwriter commission | 3.00% | ||
Shares available for future conversion (in shares) | 0.9 |
Equity Transactions - Series X
Equity Transactions - Series X Preferred Stock (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Class Of Warrant Or Right [Line Items] | |||
Proceeds from issuance or sale of equity | $ 60 | ||
Series X Preferred Stock | |||
Class Of Warrant Or Right [Line Items] | |||
Stock Issued (in shares) | 4,429 | ||
Number of shares converted (in shares) | 635 | ||
Shares issued upon conversion of share (in shares) | 6,400,000 | ||
Preferred stock outstanding (in shares) | 3,794 | 4,429 | |
Series X Preferred Stock | Rights Offering | |||
Class Of Warrant Or Right [Line Items] | |||
Shares available for future conversion (in shares) | 44,300,000 | ||
Common Stock | |||
Class Of Warrant Or Right [Line Items] | |||
Stock Issued (in shares) | 15,700,000 |
Equity Transactions - Public Of
Equity Transactions - Public Offering of Common Stock and Series X1 Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2021 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Class Of Warrant Or Right [Line Items] | ||||
Common stock par value (in USD per share) | $ 0.001 | $ 0.001 | ||
Proceeds from issuance or sale of equity | $ 60 | |||
CTI Biopharma Corp. | BVF Partners, L.P. | ||||
Class Of Warrant Or Right [Line Items] | ||||
Percentage of common stock owned by others | 8.80% | 9.10% | ||
Common Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Common stock par value (in USD per share) | $ 0.001 | |||
Common stock reserved for future issuance (in shares) | 10,000 | |||
Preferred stock, conversion price (in dollars per share) | $ 2.50 | |||
Maximum ownership upon conversion | 9.99% | |||
Series X1 Preferred Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Common stock par value (in USD per share) | $ 0.001 | |||
Number of shares converted (in shares) | 0 | |||
Preferred stock outstanding (in shares) | 600 | 0 | ||
Common Stock and Series X1 Preferred Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Proceeds from issuance or sale of equity | $ 53.6 | |||
Over-Allotment Option | ||||
Class Of Warrant Or Right [Line Items] | ||||
Sale of stock (in shares) | 2,139,120 | |||
Option to purchase additional shares | 30 days | |||
Public Offering | Common Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Sale of stock (in shares) | 14,260,800 | |||
Public offering price (in dollars per share) | $ 2.50 | |||
Public Offering | Common Stock | BVF Partners, L.P. | Affiliated Entity | ||||
Class Of Warrant Or Right [Line Items] | ||||
Sale of stock (in shares) | 2,000,000 | |||
Public Offering | Series X1 Preferred Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Sale of stock (in shares) | 600 | |||
Public offering price (in dollars per share) | $ 25,000 | |||
Public Offering | Series X1 Preferred Stock | BVF Partners, L.P. | Affiliated Entity | ||||
Class Of Warrant Or Right [Line Items] | ||||
Sale of stock (in shares) | 600 |
Equity Transactions - Common St
Equity Transactions - Common Stock Authorized (Details) - shares | Dec. 31, 2021 | Jun. 30, 2021 | May 31, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | May 31, 2020 |
Share-based Payment Arrangement [Abstract] | ||||||
Common stock authorized (in shares) | 266,500,000 | 266,500,000 | 166,500,000 | 166,500,000 | 166,500,000 | 131,500,000 |
Equity Transactions - Common _2
Equity Transactions - Common Stock Reserved (Details) - shares | Dec. 31, 2021 | Jun. 30, 2021 | May 31, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | May 31, 2020 |
Class of Stock [Line Items] | ||||||
Common stock authorized (in shares) | 266,500,000 | 266,500,000 | 166,500,000 | 166,500,000 | 166,500,000 | 131,500,000 |
Common stock issued (in shares) | 99,763,922 | 75,896,884 | ||||
Common stock outstanding (in shares) | 99,763,922 | 75,896,884 | ||||
Common stock available for future issuance (in shares) | 88,200,000 | |||||
Total common stock reserved (in shares) | 78,551,000 | |||||
Employee stock purchase plan | ||||||
Class of Stock [Line Items] | ||||||
Total common stock reserved (in shares) | 169,000 | |||||
Series O Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Total common stock reserved (in shares) | 52,323,000 | |||||
Chief Executive Officer | Stock Options | ||||||
Class of Stock [Line Items] | ||||||
Total common stock reserved (in shares) | 1,120,000 | |||||
New Hire | Stock Options | ||||||
Class of Stock [Line Items] | ||||||
Total common stock reserved (in shares) | 2,382,000 | |||||
Equity incentive plans | ||||||
Class of Stock [Line Items] | ||||||
Total common stock reserved (in shares) | 21,738,000 | |||||
Common stock purchase warrants | ||||||
Class of Stock [Line Items] | ||||||
Total common stock reserved (in shares) | 819,000 |
Equity Transactions - Warrants
Equity Transactions - Warrants (Detail) - Loan and Security Agreement - Employee stock purchase plan | Dec. 31, 2021$ / sharesshares |
Class Of Warrant Or Right [Line Items] | |
Number of warrants issued (in shares) | shares | 169,014 |
Warrant exercise price (in dollars per share) | $ / shares | $ 2.84 |
Collaboration, Licensing and _2
Collaboration, Licensing and Milestone Agreements (Details) - USD ($) $ in Millions | Mar. 17, 2022 | Dec. 31, 2021 | Oct. 31, 2016 | May 31, 2012 | Jun. 30, 2005 |
S_BIO Asset Purchase Agreement | Subsequent Event | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Milestone payments through the issuance of stock | 50.00% | ||||
S_BIO Asset Purchase Agreement | S*Bio | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Contingency milestone payment to be made | $ 132.5 | ||||
S_BIO Asset Purchase Agreement | S*Bio | Subsequent Event | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Contingency milestone payable | $ 25 | ||||
Collaborative Arrangement | Teva Pharmaceutical Industries Ltd | Products | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Contingency milestone payment to be received | $ 100 | ||||
Milestone payments earned | $ 60 | ||||
Borrowing Associated With License Agreement | Asset Return and Termination Agreement | Baxalata | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Contingency milestone payment to be made | $ 10.3 | ||||
Borrowing Associated With License Agreement | Asset Return and Termination Agreement | Takeda | Subsequent Event | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Contingency milestone payable | $ 10.3 |
Equity-Based Compensation - Sum
Equity-Based Compensation - Summary of Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Equity-based compensation expense | $ 4,743 | $ 4,317 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Equity-based compensation expense | 758 | 522 |
Selling, general and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Equity-based compensation expense | $ 3,985 | $ 3,795 |
Equity-Based Compensation - Add
Equity-Based Compensation - Additional Information (Detail) | Mar. 20, 2017 | May 31, 2017 | Mar. 31, 2017installment$ / sharesshares | Dec. 31, 2021USD ($)offering$ / sharesshares | Dec. 31, 2020USD ($)$ / shares | Jun. 30, 2021shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Equity-based compensation expense | $ | $ 4,743,000 | $ 4,317,000 | ||||
Unrecognized compensation cost | $ | $ 9,000,000 | |||||
Recognition period | 2 years 10 days | |||||
Tax benefits attributed to share-based compensation expense | $ | $ 0 | $ 0 | ||||
Shares of common stock reserved for future issuance (in shares) | 78,551,000 | |||||
Stock offerings per year | offering | 2 | |||||
Length of offerings | 6 months | |||||
Chief Executive Officer | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Options expiration period | 10 years | |||||
Options granted in period (in shares) | 1,200,000 | |||||
Exercise price of options granted (in dollars per share) | $ / shares | $ 4.24 | |||||
Number semi-annual vesting installments | installment | 6 | |||||
Vesting period | 3 years | |||||
New Hire | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Options expiration period | 10 years | |||||
Options granted in period (in shares) | 2,400,000 | |||||
Exercise price of options granted (in dollars per share) | $ / shares | $ 2.79 | |||||
Vesting period | 4 years | |||||
2007 Equity Incentive Stock Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares authorized for issuance (in shares) | 24,300,000 | |||||
Shares available for future grants (in shares) | 4,500,000 | |||||
Stock Option Plan, 2015 | Chief Executive Officer | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Options granted in period (in shares) | 80,000 | |||||
Common stock purchase warrants | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares of common stock reserved for future issuance (in shares) | 819,000 | |||||
Stock Options | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Exercise price of options granted (in dollars per share) | $ / shares | $ 3.04 | |||||
Weighted average exercise price of options exercisable (in dollars per share) | $ / shares | 2.39 | $ 3.01 | ||||
Weighted average fair value of options granted (in USD per share) | $ / shares | $ 2.07 | $ 0.76 | ||||
Stock Options | 2007 Equity Incentive Stock Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Options expiration period | 10 years | |||||
Employee stock | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares of common stock reserved for future issuance (in shares) | 800,000 | |||||
Employee stock | Common stock purchase warrants | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares of common stock reserved for future issuance (in shares) | 800,000 | |||||
Shares authorized for issuance (in shares) | 1,000,000 | |||||
Purchase price of common stock, percentage of fair market value | 85.00% | |||||
Shares issued in period (in shares) | 100,000 |
Equity-Based Compensation - Wei
Equity-Based Compensation - Weighted Average Assumptions (Detail) - Stock Options | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 0.80% | 0.50% |
Expected dividend yield | 0.00% | 0.00% |
Expected life (in years) | 5 years 2 months 12 days | 4 years 7 months 6 days |
Volatility | 101.00% | 88.00% |
Equity-Based Compensation - Sto
Equity-Based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Weighted Average Exercise Price | ||
Aggregate Intrinsic Value, Exercised at end of period | $ 200 | |
Stock Options | ||
Options | ||
Options, Beginning Balance (in shares) | 15,596,000 | |
Options, Granted (in shares) | 5,773,000 | |
Options, Exercised (in shares) | (143,000) | |
Options, Forfeited (in shares) | (194,000) | |
Options, Cancelled and expired (in shares) | (341,000) | |
Options, Ending Balance (in shares) | 20,691,000 | |
Options, Vested or expected to vest (in shares) | 19,781,000 | |
Options, Exercisable (in shares) | 11,776,000 | 8,099,000 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Beginning balance (in dollars per share) | $ 2.09 | |
Weighted Average Exercise Price, Granted (in dollars per share) | 3.04 | |
Weighted Average Exercise Price, Exercised (in dollars per share) | 0.97 | |
Weighted Average Exercise Price, Forfeited (in dollars per share) | 2.72 | |
Weighted Average Exercise Price, Cancelled and expired (in dollars per share) | 4.90 | |
Weighted Average Exercise Price, Ending balance (in dollars per share) | 2.31 | |
Weighted Average Exercise Price, Vested or expected to vest (in dollars per share) | 2.29 | |
Weighted Average Exercise Price, Exercisable (in dollars per share) | $ 2.39 | $ 3.01 |
Weighted Average Remaining Contractual Term, Outstanding at end of period | 7 years 8 months 12 days | |
Weighted Average Remaining Contractual Term, Vested and expected to vest at end of period | 7 years 7 months 6 days | |
Weighted Average Remaining Contractual Term, Exercisable at end of period | 6 years 10 months 24 days | |
Aggregate Intrinsic Value, Outstanding at end of period | $ 15,336 | |
Aggregate Intrinsic Value, Vested and expected to vest at end of period | 15,175 | |
Aggregate Intrinsic Value, Exercisable at end of period | $ 9,781 |
Employee Benefit Plans (Detail)
Employee Benefit Plans (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | ||
Maximum percentage of annual contributions per employee | 80.00% | |
Discretionary matching contributions | $ 0.3 | $ 0.1 |
Net Loss Per Share - Calculatio
Net Loss Per Share - Calculation of Basic & Diluted Net Loss (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Earnings Per Share [Abstract] | ||
Net loss available to common stockholders, basic | $ (97,908) | $ (52,451) |
Net loss available to common stockholders, diluted | $ (97,908) | $ (52,451) |
Basic and diluted: | ||
Weighted average shares outstanding (in shares) | 90,117 | 71,146 |
Less: weighted average restricted shares outstanding (in shares) | 0 | (5) |
Shares used in calculation of net loss per common share, basic (in shares) | 90,117 | 71,141 |
Shares used in calculation of net loss per common share, diluted (in shares) | 90,117 | 71,141 |
Net loss per common share: Basic (in dollars per share) | $ (1.09) | $ (0.74) |
Net loss per common share: Diluted (in dollars per share) | $ (1.09) | $ (0.74) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares shares in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Earnings Per Share [Abstract] | ||
Anti-dilutive securities excluded from computation of let loss per share (in shares) | 74.5 | 56.9 |
Commitments and Contingencies (
Commitments and Contingencies (Detail) - VAT Assessments € in Thousands, $ in Millions | 1 Months Ended | |||||||
Mar. 31, 2014EUR (€) | Mar. 31, 2014USD ($) | Nov. 30, 2013EUR (€) | Dec. 31, 2021EUR (€) | Dec. 31, 2021USD ($) | Dec. 31, 2007EUR (€) | Dec. 31, 2006EUR (€) | Dec. 31, 2003EUR (€) | |
Loss Contingencies [Line Items] | ||||||||
Estimate of possible loss | € 4,400 | $ 4.9 | € 900 | € 2,800 | € 700 | |||
Taxes paid | € 400 | $ 0.6 | ||||||
Payments for attorney fees | € 12 |
Income Taxes - Loss Before Inco
Income Taxes - Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (97,908) | $ (52,451) |
Foreign | 0 | 0 |
Net loss | $ (97,908) | $ (52,451) |
Income Taxes - Reconciliation B
Income Taxes - Reconciliation Between Effective and Income Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax rate | 21.00% | 21.00% |
Research and development tax credits | 5.00% | 4.00% |
Non-deductible compensation | (1.00%) | (2.00%) |
Valuation allowance | (24.00%) | 20.00% |
Receivable impairment | 0.00% | (2.00%) |
Expired tax attribute carryforwards / Section 382 limitation | 0.00% | (29.00%) |
Loss on subsidiary liquidation | 0.00% | (14.00%) |
Unrecognized tax benefits | (1.00%) | 2.00% |
Net effective tax rate | 0.00% | 0.00% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 40,061 | $ 22,756 |
Capitalized research and development | 35,910 | 33,280 |
Research and development tax credit carryforwards | 5,386 | 1,779 |
Equity-based compensation | 3,337 | 3,176 |
Intangible assets | 7,026 | 7,251 |
Depreciation and amortization | 785 | 699 |
Lease liability | 670 | 629 |
Other deferred tax assets | 231 | 312 |
Total deferred tax assets | 93,406 | 69,882 |
Less: valuation allowance | (92,395) | (69,085) |
Deferred Tax Assets, Net of Valuation Allowance, Total | 1,011 | 797 |
Deferred tax liabilities: | ||
Right-of-use asset | (656) | (451) |
Deductions for tax in excess of financial statements | (355) | (346) |
Total deferred tax liabilities | (1,011) | (797) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax [Line Items] | |||
Net operating losses with an indefinite life | $ 170,700,000 | ||
U.S. federal tax credits | 5,400,000 | $ 1,800,000 | |
Increase (decrease) in valuation allowance | 23,300,000 | ||
Unrecognized tax benefits | 1,209,000 | 390,000 | $ 1,268,000 |
Accrued interest or penalties related to unrecognized tax benefits | 0 | ||
Domestic Tax Authority | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards (decrease) | 182,700,000 | 99,900,000 | |
State and Local Jurisdiction | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards (decrease) | $ 15,000,000 | $ 12,300,000 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of period | $ 390 | $ 1,268 |
Gross increases to tax positions in prior periods | 0 | 0 |
Gross decreases to tax positions in current periods | 0 | (1,268) |
Gross increases to tax positions in current periods | 819 | 390 |
Balance at end of period | $ 1,209 | $ 390 |