Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 21, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Current Fiscal Year End Date | --12-31 | ||
Document Period End Date | Dec. 31, 2022 | ||
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 | $ 625.7 | ||
Entity Common Stock, Shares Outstanding | 131,835,892 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement relating to its 2023 annual meeting of stockholders, or the 2023 Proxy Statement, are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. We expect to file the 2023 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 | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0000891293 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Auditor Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Seattle, Washington |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 30,420 | $ 65,446 |
Short-term investments | 49,519 | 0 |
Accounts receivable, net | 15,387 | 0 |
Inventories | 733 | 0 |
Prepaid expenses and other current assets | 3,337 | 2,933 |
Total current assets | 99,396 | 68,379 |
Property and equipment, net | 0 | 176 |
Intangible assets, net | 23,226 | 0 |
Other assets | 3,303 | 3,879 |
Total assets | 125,925 | 72,434 |
Current liabilities: | ||
Accounts payable | 2,008 | 3,891 |
Accrued expenses | 29,402 | 12,720 |
Current portion of long-term debt | 47,943 | 47,380 |
Other current liabilities | 1,781 | 2,660 |
Total current liabilities | 81,134 | 66,651 |
Royalty financing obligation | 61,134 | 0 |
Other liabilities | 1,234 | 2,016 |
Total liabilities | 143,502 | 68,667 |
Commitments and contingencies (Note 14) | ||
Stockholders' (deficit) equity: | ||
Common stock, $0.001 par value per share: | 131 | 100 |
Additional paid-in capital | 2,501,234 | 2,429,582 |
Accumulated other comprehensive loss | (35) | 0 |
Accumulated deficit | (2,518,907) | (2,425,915) |
Total stockholders' (deficit) equity | (17,577) | 3,767 |
Total liabilities and stockholders' (deficit) equity | $ 125,925 | $ 72,434 |
Common stock authorized (in shares) | 266,500,000 | 266,500,000 |
Series O Preferred Stock | ||
Stockholders' (deficit) equity: | ||
Preferred stock, $0.001 par value per share: | $ 0 | $ 0 |
Series X Preferred Stock | ||
Stockholders' (deficit) equity: | ||
Preferred stock, $0.001 par value per share: | 0 | 0 |
Series X1 Preferred Stock | ||
Stockholders' (deficit) equity: | ||
Preferred stock, $0.001 par value per share: | $ 0 | $ 0 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
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 dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 266,500,000 | 266,500,000 |
Common stock issued (in shares) | 130,747,161 | 99,763,922 |
Common stock outstanding (in shares) | 130,747,161 | 99,763,922 |
Series O Preferred Stock | ||
Preferred stock issued (in shares) | 0 | 12,575 |
Preferred stock outstanding (in shares) | 0 | 12,575 |
Preferred stock liquidation preference | $ 0 | $ 25,150 |
Series X Preferred Stock | ||
Preferred stock issued (in shares) | 3,047 | 3,794 |
Preferred stock outstanding (in shares) | 3,047 | 3,794 |
Preferred stock liquidation preference | $ 30,470 | $ 37,940 |
Series X1 Preferred Stock | ||
Preferred stock issued (in shares) | 600 | 600 |
Preferred stock outstanding (in shares) | 600 | 600 |
Preferred stock liquidation preference | $ 15,000 | $ 15,000 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Net product sales | $ 53,948 | $ 0 |
Operating costs and expenses: | ||
Cost of sales | 3,514 | 0 |
Research and development | 36,895 | 39,136 |
Selling, general and administrative | 84,826 | 56,196 |
Other operating expenses | 8,510 | 0 |
Total operating costs and expenses | 133,745 | 95,332 |
Loss from operations | (79,797) | (95,332) |
Non-operating expenses: | ||
Interest expense, net | (13,139) | (2,415) |
Other non-operating expenses | (56) | (161) |
Total non-operating expenses | (13,195) | (2,576) |
Net loss | $ (92,992) | $ (97,908) |
Net loss per common share: Basic (in dollars per share) | $ (0.81) | $ (1.09) |
Net loss per common share: Diluted (in dollars per share) | $ (0.81) | $ (1.09) |
Shares used in calculation of net loss per common share, basic (in shares) | 114,694 | 90,117 |
Shares used in calculation of net loss per common share, diluted (in shares) | 114,694 | 90,117 |
STATEMENTS OF COMPREHENSIVE LOS
STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (92,992) | $ (97,908) |
Other comprehensive loss: | ||
Change in unrealized loss on marketable securities | (35) | (2) |
Other comprehensive loss | (35) | (2) |
Comprehensive loss | $ (93,027) | $ (97,910) |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Common Stock | Common Stock and Series X1 Preferred Stock | Series O Preferred Stock | Series X Preferred Stock | Preferred Stock | Preferred Stock Common Stock and Series X1 Preferred Stock | Preferred Stock Series O Preferred Stock | Preferred Stock Series X Preferred Stock | Common Stock | Common Stock Common Stock | Common Stock Common Stock and Series X1 Preferred Stock | Common Stock Series O Preferred Stock | Common Stock Series X Preferred Stock | Additional Paid-in Capital | Additional Paid-in Capital Common Stock | Additional Paid-in Capital Common Stock and Series X1 Preferred Stock | Additional Paid-in Capital Series O Preferred Stock | Additional Paid-in Capital Series X Preferred Stock | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2020 | 17,000 | ||||||||||||||||||||
Beginning Balance (in shares) at Dec. 31, 2020 | 75,897,000 | ||||||||||||||||||||
Beginning Balance at Dec. 31, 2020 | $ 40,029 | $ 0 | $ 76 | $ 2,367,958 | $ 2 | $ (2,328,007) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 1,000 | 858,000 | 16,400,000 | ||||||||||||||||||
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) | (1,000) | 6,350,000 | |||||||||||||||||||
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) | 263,000 | ||||||||||||||||||||
Exercise of stock options and shares issued under employee stock purchase plan | 390 | 390 | |||||||||||||||||||
Cancellation of restricted stock (in shares) | (4,000) | ||||||||||||||||||||
Net loss | (97,908) | (97,908) | |||||||||||||||||||
Other comprehensive loss | $ (2) | (2) | |||||||||||||||||||
Ending Balance (in shares) at Dec. 31, 2021 | 12,575 | 3,794 | 17,000 | ||||||||||||||||||
Ending Balance (in shares) at Dec. 31, 2021 | 99,763,922 | 99,764,000 | |||||||||||||||||||
Ending Balance at Dec. 31, 2021 | $ 3,767 | $ 0 | $ 100 | 2,429,582 | 0 | (2,425,915) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 11,042,000 | ||||||||||||||||||||
Issuance of common stock, net of issuance costs | $ 54,895 | $ 11 | $ 54,884 | ||||||||||||||||||
Conversion of Series X preferred stock to common stock (in shares) | (13,000) | 8,383,000 | 7,470,000 | ||||||||||||||||||
Conversion of Series X preferred stock to common stock | $ 0 | $ 0 | $ 8 | $ 8 | $ (8) | $ (8) | |||||||||||||||
Equity-based compensation | 10,030 | 10,030 | |||||||||||||||||||
Exercise of stock options and shares issued under employee stock purchase plan (in shares) | 4,088,000 | ||||||||||||||||||||
Exercise of stock options and shares issued under employee stock purchase plan | 6,758 | $ 4 | 6,754 | ||||||||||||||||||
Net loss | (92,992) | (92,992) | |||||||||||||||||||
Other comprehensive loss | $ (35) | (35) | |||||||||||||||||||
Ending Balance (in shares) at Dec. 31, 2022 | 0 | 3,047 | 4,000 | ||||||||||||||||||
Ending Balance (in shares) at Dec. 31, 2022 | 130,747,161 | 130,747,000 | |||||||||||||||||||
Ending Balance at Dec. 31, 2022 | $ (17,577) | $ 0 | $ 131 | $ 2,501,234 | $ (35) | $ (2,518,907) |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | ||
Net loss | $ (92,992) | $ (97,908) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Equity-based compensation expense | 10,030 | 4,743 |
Imputed interest expense on royalty financing obligation | 8,001 | 0 |
Depreciation and amortization | 1,951 | 526 |
Other | (265) | (113) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (15,387) | 0 |
Inventories | (733) | 0 |
Prepaid expenses and other assets | 464 | 2,278 |
Accounts payable, accrued expenses and other liabilities | 7,737 | 5,585 |
Net cash used in operating activities | (81,194) | (84,889) |
Investing activities | ||
Milestone payment to S*BIO Pte Ltd. | (25,000) | 0 |
Purchases of short-term investments | (88,853) | 0 |
Proceeds from maturities of short-term investments | 40,000 | 12,000 |
Net cash (used in) provided by investing activities | (73,853) | 12,000 |
Financing activities | ||
Repayment of Silicon Valley Bank debt | 0 | (6,329) |
Proceeds from stock option exercises | 4,934 | 156 |
Proceeds from ESPP stock issuance | 1,432 | 252 |
Net cash provided by financing activities | 120,021 | 97,941 |
Net (decrease) increase in cash and cash equivalents | (35,026) | 25,052 |
Cash and cash equivalents at beginning of year | 65,446 | 40,394 |
Cash and cash equivalents at end of year | 30,420 | 65,446 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 6,134 | 1,950 |
Supplemental disclosure of noncash financing and investing activities | ||
Conversion of preferred stock to common stock | 32,530 | 6,350 |
Drug Royalty III LP 2 Credit Agreement | ||
Financing activities | ||
Gross proceeds from DRI Credit Agreement | 0 | 50,000 |
Cash paid for issuance costs | 0 | (1,813) |
Royalty Financing Agreement | ||
Financing activities | ||
Cash paid for issuance costs | (1,284) | (531) |
Gross proceeds from DRI Royalty Financing Agreement | 60,000 | 0 |
Common Stock and Series X1 Preferred Stock | ||
Financing activities | ||
Gross proceeds from public offering of common stock and Series X1 preferred stock | 0 | 56,000 |
Cash paid for offering costs | 0 | (2,447) |
At-The-Market Equity, Common Stock | ||
Financing activities | ||
Cash paid for offering costs | (2,004) | (411) |
Gross proceeds from offering | $ 56,943 | $ 3,064 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
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., also referred to in these financial statements as “we,” “us,” “our,” the “Company” and “CTI,” is a commercial 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 on February 28, 2022 from the U.S. Food and Drug Administration, or 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 March 2022. We are conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement. 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, the European Medicines Agency, or 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. Liquidity The accompanying financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the 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. While we have seen strong refill demand and expect revenues from VONJO to be one of our primary sources of liquidity, we may not be able to accurately predict the market acceptance or growth trajectory of VONJO’s revenues. We project operating expenses, when offset against our projected revenues, will result in operating losses for the foreseeable future as we expect to conduct research, development, testing and regulatory compliance activities with respect to other development pathways for pacritinib. We have incurred a net operating loss every year since our formation and expect to continue to incur net losses for the foreseeable future. As of December 31, 2022, we had an accumulated deficit of $2.5 billion. Our available cash, cash equivalents and short-term investments were $79.9 million as of December 31, 2022. We expect that our present financial resources, together with expected cash receipts from net product sales of VONJO and the $6.5 million in additional contractual funding received from DRI in January 2023 in connection with the achievement of minimum net product sales of VONJO, will be sufficient to meet our obligations as they come due and to fund our operations at least through the fourth quarter of 2023. Based on our evaluation completed pursuant to ASC 205-40 Presentation of Financial Statements-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. We will require additional capital in order to pursue our longer-term strategic objectives. We expect to satisfy our capital needs through existing capital balances, revenues from VONJO, and a combination of public or private equity financings, partnerships, collaborations, joint ventures, disposition of assets, 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 at affordable rates with competitive terms, be unable to or elect to 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 of ongoing organization and maintenance of our commercial infrastructure and distribution capabilities; our ability to reach milestones triggering payments to be made or received 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 approval for products that we may develop in the future; 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 ongoing worldwide current events; and other unplanned business developments. In addition, our ability to comply with covenants under our Credit Agreement, or the Credit Agreement, with Drug Royalty III LP 2, or DRI, 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. The Credit Agreement also contains a minimum liquidity covenant requiring us to maintain at least $10.0 million of unrestricted cash and cash equivalents, subject to certain exceptions. The accompanying financial statements do not include adjustments, if any, that may result from the outcome of this uncertainty. See 8. Debt Financing Arrangements for additional information regarding the Credit Agreement with DRI. 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 in the financial statements and accompanying notes. Estimates are used for, but not limited to, evaluation of going concern and classification of liabilities, net product sales, clinical accruals, intangible assets, interest expense on royalty financing obligation, income taxes, commitments and contingencies, equity-based compensation and the collectability of receivables. Given the global economic climate, these estimates are becoming more challenging, and actual results could differ materially from those estimates. Segment Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. 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 revenues and assets are related to our operations in the United States. Concentrations of Credit Risk and Uncertainties Our VONJO product sales are concentrated in a number of specialty distributor customers and specialty pharmacy customers. The following table presents each customer that accounted for more than 10% of total net product sales for the year ended December 31, 2022: December 31, 2022 Customer A 30 % Customer B 23 % Customer C 21 % Customer D 17 % Cash, cash equivalents, short-term investments and accounts receivable are financial instruments that potentially subject us to concentrations of credit risk. All of our accounts receivable relate to VONJO product sales. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts or other hedging arrangements. We have not experienced any significant credit losses on cash, cash equivalents, short-term investments or accounts receivable to date and do not require collateral on accounts receivable. To estimate credit losses for accounts receivable, we consider our historical experience and other currently available information, including customer financial condition, as well as current and forecasted economic conditions affecting our customers. We consider the risk of potential credit losses to be low based on our evaluation of the creditworthiness of our customers who are specialty distributors and specialty pharmacies. 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, 2022 and 2021, 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, 2022 and 2021. 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, 2022 December 31, 2021 Cost or Amortized Cost Gross Unrealized Losses Fair Value Fair Value Cash $ 337 $ — $ 337 $ 137 Level 1 securities: Money market funds 30,083 — 30,083 65,309 Level 2 securities: Corporate debt securities 49,554 (35) 49,519 — Total cash, cash equivalents and short-term investments $ 79,974 $ (35) $ 79,939 $ 65,446 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 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. As of December 31, 2022 and 2021, the carrying value of our receivables, payables and accruals approximated their fair values due to the short-term nature of these items. As of December 31, 2022 and 2021, the carrying value of our term loan under the Credit Agreement (See Note 8. Debt Financing Arrangements) approximated its fair value based on borrowing rates for similar loans and maturities, which are considered Level 2 measurements. As of December 31, 2022, the carrying value of royalty financing obligation under the Royalty Financing Agreement (See Note 8. Debt Financing Arrangements) approximated its fair value and was measured using the estimates of future net product sales (and resulting royalty payments) based on key assumptions such as population, market penetration and forecasts from market data sources, which are considered Level 3 measurements. 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. Accounts Receivable Accounts receivable, net consist of amounts due from customers, net of customer allowances for prompt-pay discounts, chargebacks, rebates and product returns, as well as distribution service fees. Accounts receivable are stated at amortized cost less allowance for credit losses. Our standard credit terms range from 30 days to 66 days, and all arrangements are payable within one year of the transfer of control of the product; as such, we do not adjust our revenues for the effects of a significant financing component. We analyze past due accounts for collectability and periodically evaluate the creditworthiness of our customers. As of December 31, 2022, we determined that an allowance for credit losses was not required based on our review of customer accounts and individual circumstances. Inventories Prior to regulatory approval, we expense costs related to the production of inventories as research and development expenses in the period in which they are incurred because product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. Subsequent to regulatory approval, we capitalize costs incurred to manufacture our products as inventories when the related costs are expected to be recoverable through the commercialization of the product. VONJO inventory that is deployed for clinical, research or development purposes is charged to research and development expense. As of December 31, 2022, inventories consisted of active pharmaceutical ingredients and capitalized shipping, packaging and labeling costs incurred subsequent to FDA approval of VONJO. Inventories are recorded at the lower of cost and net realizable value with the cost of inventories determined on a specific identification basis in a manner that approximates the first-in, first-out method. We perform an assessment of the recoverability of capitalized inventory during each reporting period and write down excess and obsolete inventories to their net realizable value in the period in which the impairment is first identified. 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 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 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 balance sheets. Intangible Assets Intangible assets as of December 31, 2022 consisted of a capitalized milestone payment incurred upon FDA approval and commercialization of VONJO during the first quarter of 2022. See “Note 10. Collaboration, Licensing and Milestone Agreements - S*BIO Pte Ltd. ” for additional details. Intangible assets are amortized on a straight-line basis over the patent life of the VONJO product compound, which was 11.9 years upon FDA approval, with a remaining amortization period of 11.0 years as of December 31, 2022. For the year ended December 31, 2022, we recognized $1.8 million of amortization expense, which was included in Cost of sales . We expect the amount of amortization expense to be $2.1 million annually prior to the year of patent expiry. The gross carrying amount and accumulated amortization were $25.0 million and $1.8 million as of December 31, 2022, respectively. We review for impairment when events or circumstances indicate that the carrying value of intangible assets may not be recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset and its eventual disposition are less than its carrying amount. Such estimated undiscounted future cash flows are derived from projected sales of VONJO and other competitive factors. The amount of impairment is measured as the difference between the carrying amount and the fair value of the impaired asset. Net Product Sales On February 28, 2022, the FDA granted Accelerated Approval of VONJO 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 March 2022. We entered into a limited number of distribution arrangements with specialty distributors and specialty pharmacies in the United States to distribute VONJO . Our specialty pharmacy customers resell VONJO directly to patients while our specialty distributor customers resell VONJO to healthcare entities, who then resell to patients. Such specialty distributors and specialty pharmacies are referred to as our customers in the context of ASC 606. We recognize revenue for product sales when our customers obtain control of the product, which generally occurs upon delivery. Upon receipt of the product by our customers, we recognize revenues net of variable consideration, which relates to allowances for customer credits, distribution service fees, product returns, chargebacks, rebates and co-payment assistance programs as discussed below. The reserves for these allowances are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than the customer). Taxes collected from the customer relating to product sales and remitted to governmental authorities are excluded from product sales. Customer Credits and Distribution Service Fees : Our customers are offered prompt payment discounts. We expect our customers will pay timely enough to utilize prompt payment discounts and therefore we deduct the full amount of these discounts from total product sales when revenues are recognized. In addition, we pay a fee to our customers for their sales order management, data, and distribution services to us. Distribution service fees are also deducted from total product sales as they are incurred. Returns : We offer our customers and other indirect purchasers a limited right of return for purchased units of VONJO for damaged, defective, in-dated or expired product beginning six months prior to the product’s expiration date and ending 12 months after the product’s expiration date. As we do not have sufficient historical experience with VONJO sales, we estimate the amount of product returns initially based on data from similar products and other qualitative considerations, such as visibility into the inventory remaining in the distribution channel. Chargebacks : Chargebacks result from our contractual commitments to provide our product to discount-eligible healthcare entities, group purchasing organizations, 340B eligible covered entities and federal government entities purchasing via the Federal Supply Schedule, at prices lower than the list prices charged to our customers. Our customers charge us back for the discount provided to the contracted entities. Our reserves for chargebacks consist of credits that we expect to issue for units that remain in the distribution channel inventory, which we expect will be sold to the contracted entities, as well as chargebacks that customers have claimed, but for which we have not yet issued a credit. We record reserves for chargebacks based on contractual terms in the same period that the related revenue is recognized. Rebates : We are subject to discount and rebate obligations under government programs such as the Medicaid Drug Rebate Program, the Medicare Part D Coverage Gap Discounts Program and the 340B Drug Pricing Program, as well as under commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory or contractual discount rates and expected utilization. Our estimates for the expected utilization of rebates are based on data received from our customers and historical utilization rates observed subsequent to product launch. Our accrual for these rebates consists of invoices received for claims from prior and current quarters that have not been paid or for which an invoice has not yet been received as well as estimates of claims for the current period's shipment to our customers, which include estimated future claims that will be made for product that has been recognized as revenue but which remains in distribution channel inventories at the end of the reporting period. Co-payment Assistance : We offer co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption based on data provided by the third-party administrator. Cost of Sales Cost of sales includes the cost of manufacturing inventories that are related to product sales, including overhead costs, amortization expense for intangible assets, and third-party royalties payable on net product sales. In addition, shipping and handling costs for product shipments are recorded in cost of sales as incurred. Cost of sales may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs and manufacturing variances. For the year ended December 31, 2022, cost of sales primarily consisted of amortization expense for intangible assets, shipping and handling costs, and third-party royalty costs. Substantially all of the manufacturing costs of VONJO product sold during the current period were previously expensed as 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. Advertising Advertising costs are expensed as incurred. Advertising expenses, recorded in Selling, general and administrative expenses, were $14.8 million for the year ended December 31, 2022. We had no comparable advertising expenses for the year ended December 31, 2021. 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. 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. Future realization of deferred tax assets is dependent upon a number of factors, including the existence of sufficient taxable income based on future earnings, the timing and amount of which is uncertain. The assessment regarding whether a valuation allowance is required considers the evaluation of both positive and negative evidence when concluding whether it is more likely than not that deferred tax assets are realizable. Based upon a review of all available evidence, we determined that it is not more likely than not that the U.S. deferred tax assets will be realized, and therefore the deferred tax assets have been fully offset by a valuation allowance. 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 stock options, warrants and restricted stock, using the treasury stock method, as their inclusion would have an anti-dilutive effect. Recently Issued Accounting Standards In March 2020, the Financial Accounting Standards Board, or the FASB, issued 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 8. Debt Financing Arrangements”, in August 2021, we entered into the 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 reference rate occurs. We do not expect the adoption of this guidance to have a material impact on our 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 financial statements. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | 2. Inventories Inventories consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Raw materials $ 156 $ — Work-in-process 496 — Finished goods 81 — Total inventories $ 733 $ — |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Furniture and office equipment $ 597 $ 597 Leasehold improvements 1,755 5,140 2,352 5,737 Less: accumulated depreciation and amortization (2,352) (5,561) Property and equipment, net $ — $ 176 |
Other Assets
Other Assets | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Assets | 4. Other Assets Other assets consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Right-of-use assets $ 2,078 $ 3,109 Prepaid manufacturing 855 — Clinical trial deposits 370 770 Total other assets $ 3,303 $ 3,879 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Milestone payment due to Takeda Pharmaceutical Company Limited (1) $ 10,291 $ — Employee compensation and related expenses 7,207 4,783 Clinical trial expenses 5,256 4,053 Royalty expenses 2,446 — Commercial expenses 2,424 3,075 Accrued rebates 1,289 — Other 489 809 Total accrued expenses $ 29,402 $ 12,720 (1) See “Note 10. Collaboration, Licensing and Milestone Agreements - Baxalta ” |
Other Current Liabilities
Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Other Liabilities Disclosure [Abstract] | |
Other Current Liabilities | 6. Other Current Liabilities Other current liabilities consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Operating lease liabilities - current $ 781 $ 1,160 End-of-facility lender fee (1) 1,000 1,000 Other current obligations — 500 Total other current liabilities $ 1,781 $ 2,660 (1) The end-of-facility lender fee as of December 31, 2022 and 2021 represents an amount payable to DRI, upon repayment of our secured term loan under the Credit Agreement with DRI. See “Note 8. Debt Financing Arrangements” for additional information. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | 7. 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. 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 is 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. We also lease parking space under the agreement. We elected not to separate a non-lease component from a lease component for the parking lease. In addition, the agreement to sublease approximately 44,000 square feet of our office space was terminated in April 2022. 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 statements of operations, were as follows (in thousands): Year Ended December 31, 2022 2021 Operating lease expense $ 1,208 $ 1,586 Variable lease expense 50 183 Sublease income (415) (1,254) Total lease expense, net $ 843 $ 515 The balance sheet classification of operating lease right-of-use assets and operating lease liabilities were as follows (in thousands): December 31, 2022 Right-of-use assets (included in Other Assets ) $ 2,078 Operating lease liabilities, current (included in Other current liabilities ) $ 781 Operating lease liabilities, non-current (included in Other liabilities, less current portion ) 1,234 Total lease liabilities $ 2,015 As of December 31, 2022, the maturities of operating lease liabilities were as follows (in thousands): Operating Lease Payments 2023 $ 975 2024 1,002 2025 337 Thereafter — Total payments 2,314 Less imputed interest (299) Total lease liabilities $ 2,015 Supplemental information relating to our operating leases is as follows (in thousands): December 31, 2022 Supplemental cash flow information Cash paid for amounts included in the measurement of lease liabilities $ 1,450 Weighted-average remaining lease term of operating leases (years) 2.33 Weighted-average discount rate of operating leases 11.6 % |
Debt Financing Agreements
Debt Financing Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt Financing Agreements | 8. Debt Financing Arrangements Drug Royalty III LP 2 Credit Agreement In August 2021, we entered into a Credit Agreement with 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. Upon 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 6. Other Current Liabilities” for additional information. 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. The Credit Agreement also 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 permanent waiver of breach of such covenant from DRI. As of December 31, 2022, 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, at issuance, of which $1.1 million and $1.0 million were unamortized as of December 31, 2022, 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 balance sheet as of December 31, 2022 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, that is not within our control. We have not been notified by DRI that an event of default has been triggered as of the date of the filing of this Annual Report on Form 10-K. As of December 31, 2022, the scheduled principal and interest payments (based on the interest rate of 13.06% as of December 31, 2022) as well as the back-end fee described above are as follows (in thousands): Principal Interest Back-end fee Total 2023 $ — $ 6,622 $ — $ 6,622 2024 — 6,640 — 6,640 2025 — 6,622 — 6,622 2026 and thereafter 50,000 4,282 1,000 55,282 Total scheduled payments $ 50,000 $ 24,166 $ 1,000 $ 75,166 Less: debt discount and issuance costs (2,057) Current portion of long-term debt $ 47,943 Royalty Financing Agreement In August 2021, 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 royalties based 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 February 2022. In January 2023, we received $6.5 million in additional funding in connection with the achievement of a certain minimum VONJO sales threshold. DRI will be required to provide up to $18.5 million of remaining contractual funding if certain minimum VONJO sales thresholds are met by the end of the third quarter of 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 until the patent expiry of the VONJO product compound. 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 our ability to incur certain indebtedness, which restrictions are eliminated after the earliest of: (a) 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 clauses and other provisions customary for transactions of this nature. Certain of these provisions would, if deemed probable, result in the recognition of an embedded feature. However, we do not believe such provisions are probable at this time. The Royalty Financing Agreement does not contain subjective acceleration clauses or provisions that would require repayment of funding. We 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, the funding from DRI is recorded as Royalty financing obligation on our balance sheet. The Royalty Financing Agreement does not contain subjective acceleration clauses or provisions that would require repayment of funding; as such, the funding received under the Royalty Financing Agreement is classified in long-term liabilities. In connection with the Royalty Financing Agreement, we recorded debt issuance costs of $1.8 million, of which $1.7 million remained unamortized as of December 31, 2022. The royalty financing obligation is amortized over the expected repayment term using an effective interest rate method that is calculated based on the rate that would enable the debt to be repaid in full over the patent life of the VONJO product compound, which was 11.8 years upon funding, with a remaining amortization period of 11.0 years as of December 31, 2022. The effective interest rate may vary during the term of the agreement depending on a number of factors, including the amount and timing of forecasted net product sales which affects the repayment timing and ultimate amount of repayment. As of December 31, 2022, the effective interest rate was 18.8%. We recognized non-cash interest expense of $8.0 million related to the royalty financing obligation for the year ended December 31, 2022. We will evaluate the effective interest rate quarterly based on our current revenue forecasts utilizing the prospective method. The activities related to the royalty financing obligation for the year ended December 31, 2022 were as follows (in thousands): Royalty financing obligation - initial funding $ 60,000 Less: debt issuance costs (1,814) Royalty financing obligation - beginning balance $ 58,186 Accretion of imputed interest on the royalty financing obligation balance 8,001 Amortization of debt issuance costs 126 Less: Royalty payments made to DRI (3,155) Less: Royalty payable to DRI (classified in accrued expenses) (2,024) Royalty financing obligation - ending balance $ 61,134 |
Equity Transactions
Equity Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Equity Transactions | 9. Equity Transactions At-The-Market Equity Offering In January 2021, we entered into an Open Market Sale Agreement℠ with Jefferies LLC, or the 2021 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. For the year ended December 31, 2022, we sold 9.4 million shares of our common stock for approximately $45.5 million, net of sales agent commission of $1.4 million, under the 2021 Sale Agreement. As of the second quarter of 2022, all $50.0 million of the aggregate sales capacity under the 2021 Sale Agreement was fully utilized. In August 2022, we entered into a new Open Market Sale Agreement℠ with Jefferies, or the 2022 Sale Agreement, to sell shares of our common stock having aggregate sales proceeds of up to $100.0 million, from time to time, through an “at the market” equity offering program under which Jefferies acts as sales agent. The 2021 Sale Agreement was terminated when the sales agent placed the Maximum Program Amount (as defined therein). Under the 2022 Sale Agreement, we have the ability to 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 2022 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 2022 Sale Agreement at any time upon one trading day’s 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 2022 Sale Agreement. We have no obligation to sell any shares under the 2022 Sale Agreement, and may at any time suspend solicitation and offers under the 2022 Sale Agreement. For the year ended December 31, 2022, we sold 1.7 million shares of our common stock for approximately $9.7 million, net of sales agent commission of $0.3 million, under the 2022 Sale Agreement. As of December 31, 2022, the remaining facility under the 2022 Sale Agreement was $90.0 million. Series O Preferred Stock In February 2018, we issued 12,575 shares of our Series O Preferred Stock to BVF Partners L.P., or BVF, an existing stockholder of the Company, pursuant to the stock exchange agreement between BVF and the Company. Matthew D. Perry, a member of our Board, is the President of BVF and portfolio manager for the underlying funds managed by the firm. See 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, 2018 for additional information. During the year ended December 31, 2022, all of the 12,575 shares of our Series O Preferred Stock were converted into 8.4 million shares of our common stock. As of December 31, 2022, BVF beneficially owned a total of 27.1% of our common stock and as-converted preferred stock outstanding, which includes 5.3% common stock and 21.8% as-converted preferred stock, respectively. 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. See 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, 2022, 747 shares of our Series X Preferred Stock were converted into 7.5 million shares of our common stock. There were 3,047 shares of our Series X Preferred Stock outstanding as of December 31, 2022. Common Stock Authorized 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. There was no increase to the total number of authorized shares during 2022. Common Stock Reserved As of December 31, 2022, we had 266.5 million authorized shares of common stock, of which 130.7 million shares were issued and outstanding, and 53.2 million shares were available for future issuances. The remaining authorized shares were reserved as follows (in thousands): Equity incentive plans 26,278 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) 2,676 Employee stock purchase plan 831 At-the-market equity program 15,006 Convertible preferred stock 36,470 Common stock purchase warrants 169 Total common stock reserved 82,550 Warrants |
Collaboration, Licensing and Mi
Collaboration, Licensing and Milestone Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Collaborations [Abstract] | |
Collaboration, Licensing and Milestone Agreements | 10. Collaboration, Licensing and Milestone Agreements Baxalta In November 2013, we entered into a Development, Commercialization and License Agreement, or the Pacritinib License Agreement, with Baxter International Inc., or 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 Pharmaceutical Company Limited, or 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. Upon FDA approval of VONJO on February 28, 2022, the $10.3 million milestone payment became payable to Takeda and is included within Accrued expenses as of December 31, 2022. The payment was originally due 60 days following FDA approval; however, the due date was subsequently amended such that the payment is now required to be made in full on or prior to March 15, 2023, subject to our timely payment of monthly interest on the outstanding amount due at an applicable interest rate specified in the amendment. Interest payments made on the amount owed were $0.5 million in aggregate as of December 31, 2022. Since the $10.3 million payment does not relate to our intellectual property and arose from a contingency in the Baxalta Termination Agreement that was resolved in the first quarter of 2022, it was recorded in Other operating expenses for the year ended December 31, 2022. Under the terms of the Baxalta Termination Agreement, we will have no further obligations to Takeda after settlement of this payment. 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. S*BIO is also 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. Upon FDA approval of VONJO on February 28, 2022, a $25.0 million milestone payment became payable to S*BIO, which was recorded in Intangible assets, net due to the fact that this payment represents contingent consideration for the acquired pacritinib compound that became marketable and capable of generating cash flows from sales during the first quarter of 2022. The milestone payment was made to S*BIO during the second quarter of 2022. 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 convertible into our common stock. Teva |
Equity-Based Compensation
Equity-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Equity-Based Compensation | 11. Equity-Based Compensation Substantially all of equity-based compensation expense recognized during the years ended December 31, 2022 and 2021 was related to stock options. The following table summarizes equity-based compensation expense for the years ended December 31, 2022 and 2021, which was allocated as follows (in thousands): 2022 2021 Research and development $ 1,291 $ 758 Selling, general and administrative 8,739 3,985 Total equity-based compensation expense $ 10,030 $ 4,743 Equity-based compensation expense had an effect on net loss for the years ended December 31, 2022 and 2021, respectively, but had no effect on cash flows from operating activities for the periods presented. As of December 31, 2022, unrecognized compensation cost related to unvested stock options amounted to $13.0 million, which will be recognized over the remaining weighted-average requisite service period of 2.26 years. For the years ended December 31, 2022 and 2021, 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 2017 Plan was amended and restated in June 2022 to increase the maximum number of shares of the Company’s common stock authorized for issuance by 8.0 million shares. The Company's 2007 Employee Stock Purchase Plan, as amended and restated in August 2009, September 2015, June 2021 and June 2022, or the Purchase Plan, was amended in June 2022 to increase the maximum number of shares of the Company’s common stock authorized for issuance by 0.5 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, 2022, 32.5 million shares were authorized for issuance under equity incentive plans, of which 8.5 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 vested in six equal semi-annual installments over the three-year period beginning March 20, 2017. 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 were fully vested and remained outstanding as of December 31, 2022. Inducement stock options are granted to our newly-hired employees as an inducement award to each employee entering into employment with the Company. Inducement stock options are 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. As of December 31, 2022, 2.7 million inducement stock options with a weighted average exercise price of $3.25 were issued and outstanding. 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, 2022 2021 Risk-free interest rate 2.0 % 0.8 % Expected dividend yield None None Expected life (in years) 5.5 5.2 Volatility 84 % 101 % 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, 2022: Options Weighted Weighted Aggregate Outstanding at December 31, 2021 (11,776,000 exercisable) 20,691,000 $ 2.31 Granted 5,037,000 $ 4.52 Exercised (3,600,000) $ 1.48 $ 15,900 Forfeited (530,000) $ 3.40 Cancelled and expired (81,000) $ 2.66 Outstanding at December 31, 2022 (13,417,000 exercisable) 21,517,000 $ 2.94 7.0 $ 67,705 Vested or expected to vest at December 31, 2022 20,558,000 $ 2.90 6.9 $ 65,584 Exercisable at December 31, 2022 13,417,000 $ 2.51 5.9 $ 48,549 The weighted average exercise price of options exercisable at December 31, 2022 and 2021 was $2.51 and $2.39, respectively. The weighted average grant-date fair value of options granted during 2022 and 2021 was $3.14 and $2.07 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. During the year ended December 31, 2022, we issued 0.5 million shares of our common stock to employees under the Purchase Plan and recognized equity-based compensation expense of $0.7 million. The amount of equity-based compensation expense recognized during the year ended December 31, 2021 was nominal. There are 1.5 million shares of common stock authorized under the Purchase Plan and 0.8 million shares are reserved for future purchases as of December 31, 2022. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 12. 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 $1.3 million and $0.3 million related to discretionary matching contributions for the years ended December 31, 2022 and 2021, respectively. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. 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, 2022 2021 Net loss $ (92,992) $ (97,908) Basic and diluted: Weighted average common shares outstanding used in calculation of basic and diluted net loss per common share 114,694 90,117 Net loss per common share: Basic and diluted $ (0.81) $ (1.09) Common shares underlying equity awards, warrants and convertible preferred stock aggregating 68.8 million shares and 74.5 million shares prior to the application of the treasury stock method for the years ended December 31, 2022 and 2021, 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, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and Contingencies Commitments See “Note 7. Leases” and “Note 8. 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 10. 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. Legal Proceedings 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 were €0.7 million, €2.8 million and €0.9 million, respectively. We believed that the services invoiced were non-VAT taxable consultancy services and that the VAT returns were correct as originally filed. We appealed all the assessments and defended ourselves against the assessments both on procedural grounds and on the merits of the cases. The following is a summary of the outcomes of the legal proceedings surrounding each respective VAT year return at issue: 2003 VAT Assessment . In April 2022, the Italian Supreme Court rejected our arguments both on procedural grounds and on the merits of the case and ruled in favor of the ITA. Accordingly, we accrued a liability of €0.7 million for the 2003 VAT assessment, which was recorded in Other operating expenses . During the third quarter of 2022, the 2003 VAT liability was reduced to approximately €0.3 million or approximately $0.3 million converted using the currency exchange rate at the end of the third quarter of 2022, based on the application of a €0.4 million deposit made to the ITA in 2014, which was previously written off from the balance sheet. The 2003 VAT liability was settled in the fourth quarter of 2022. 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 March 2022, the Italian Supreme Court issued decision No. 10355/22 which (i) rejected the appeal of the ITA, (ii) confirmed the decision of the Regional Tax Court which ruled fully in our favor, and (iii) due to a change of law, compensated the legal expenses incurred by the parties for the appeals. We have applied for refunds based on the guidance from the ITA. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. Income Taxes We file income tax returns in the United States and Germany. We are not currently under examination by an income tax authority, nor have we been notified that an examination is contemplated. The Inflation Reduction Act of 2022, or the Act, was signed into U.S. law on August 16, 2022. The Act includes various tax provisions, including an excise tax on stock repurchases, expanded tax credits for clean energy incentives, and a corporate alternative minimum tax that generally applies to U.S. corporations with average adjusted financial statement income over a three year period in excess of $1 billion. We do not expect the Act to materially impact our financial statements. The following table presents U.S. and foreign components of loss before income taxes (in thousands): Year ended December 31, 2022 2021 United States $ (92,992) $ (97,908) Foreign — — Net loss before income taxes $ (92,992) $ (97,908) The reconciliation between the income tax rate and our effective tax rate as of December 31 is as follows: 2022 2021 Federal income tax rate 21 % 21 % State income tax rate 11 — Research and development tax credits 1 5 Equity-based compensation 1 (1) Valuation allowance (47) (24) Adjustment of tax attributes 13 — Unrecognized tax benefits — (1) Net effective tax rate — % — % The principal components of our deferred tax assets and liabilities as of December 31 were as follows (in thousands): 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 55,984 $ 40,061 Capitalized research and development 38,830 35,910 Royalty financing obligation 14,989 — Research and development tax credit carryforwards 13,942 5,386 Intangible assets 6,421 7,026 Equity-based compensation 4,827 3,337 Accrued liabilities and allowances 1,206 — Lease liability 494 670 Depreciation and amortization 316 785 Other deferred tax assets 3 231 Total deferred tax assets 137,012 93,406 Less: valuation allowance (136,051) (92,395) 961 1,011 Deferred tax liabilities: Right-of-use asset (509) (656) Other deferred tax liabilities (452) (355) Total deferred tax liabilities (961) (1,011) Net deferred tax assets $ — $ — As of December 31, 2022 and 2021, we had U.S. federal net operating loss carryforwards, or the NOL, of approximately $242.8 million and $182.7 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 $209.8 million with an indefinite life as of December 31, 2022. We have state net operating loss carryforwards of approximately $43.2 million and $15.0 million as of December 31, 2022 and 2021, respectively. We also had U.S. federal tax credits of $16.8 million and $5.4 million as of December 31, 2022 and 2021, respectively, which may be used to offset future tax liabilities. The NOL and tax credit carryforwards 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. The Tax Cuts and Jobs Act contained a provision which requires the capitalization of Section 174 costs incurred in years beginning on or after Jan. 1, 2022. Section 174 costs are expenditures which represent research and development costs that are incident to the development or improvement of a product, process, formula, invention, computer software, or technique. This provision changes the treatment of Section 174 costs such that the expenditures are no longer allowed as an immediate deduction but rather must be capitalized and amortized. We have included the impact of this provision, which results in a deferred tax asset of approximately $7.3 million as of December 31, 2022. 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 $43.7 million during the year ended December 31, 2022 primarily due to the increase in net operating loss carryforwards, tax credit carryforwards and debt basis difference on royalty financing obligation. 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 German income taxes with varying statutes of limitations. Tax years from 2003 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): 2022 2021 Balance at beginning of period $ 1,209 $ 390 Gross increases to tax positions in prior periods 1,353 — Gross decreases to tax positions in current periods — — Gross increases to tax positions in current periods 261 819 Balance at end of period $ 2,823 $ 1,209 As of December 31, 2022, the total amount of unrecognized tax benefits was $2.8 million, which was recorded as a reduction to the deferred tax asset. We do not anticipate that the amount of existing unrecognized tax benefits will significantly increase or decrease within the next 12 months. We had no accrued interest or penalties as of December 31, 2022. We have not recorded a liability for U.S. income taxes and foreign withholding taxes on the undistributed earnings of foreign subsidiaries as of December 31, 2022 as we intend to permanently reinvest future such earnings outside the United States. The amount of the unrecognized deferred tax liability, if incurred, is expected to be immaterial. |
Description of Business and S_2
Description of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Description of Business | CTI BioPharma Corp., also referred to in these financial statements as “we,” “us,” “our,” the “Company” and “CTI,” is a commercial 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 on February 28, 2022 from the U.S. Food and Drug Administration, or 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 March 2022. We are conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement. |
Liquidity | Liquidity The accompanying financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the 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 EstimatesThe 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 in the financial statements and accompanying notes. Estimates are used for, but not limited to, evaluation of going concern and classification of liabilities, net product sales, clinical accruals, intangible assets, interest expense on royalty financing obligation, income taxes, commitments and contingencies, equity-based compensation and the collectability of receivables. Given the global economic climate, these estimates are becoming more challenging, and actual results could differ materially from those estimates. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. 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 revenues and assets are related to our operations in the United States. |
Certain Risks, Uncertainties and Concentrations | Cash, cash equivalents, short-term investments and accounts receivable are financial instruments that potentially subject us to concentrations of credit risk. All of our accounts receivable relate to VONJO product sales. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts or other hedging arrangements. We have not experienced any significant credit losses on cash, cash equivalents, short-term investments or accounts receivable to date and do not require collateral on accounts receivable. To estimate credit losses for accounts receivable, we consider our historical experience and other currently available information, including customer financial condition, as well as current and forecasted economic conditions affecting our customers. We consider the risk of potential credit losses to be low based on our evaluation of the creditworthiness of our customers who are specialty distributors and specialty pharmacies. 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. Our cash equivalents and short-term investments are recorded at fair value. As of December 31, 2022 and 2021, our cash, cash equivalents and short-term investments consisted of cash, money market funds and corporate debt securities. |
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. |
Accounts Receivable | Accounts Receivable Accounts receivable, net consist of amounts due from customers, net of customer allowances for prompt-pay discounts, chargebacks, rebates and product returns, as well as distribution service fees. Accounts receivable are stated at amortized cost |
Inventories | Inventories Prior to regulatory approval, we expense costs related to the production of inventories as research and development expenses in the period in which they are incurred because product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. Subsequent to regulatory approval, we capitalize costs incurred to manufacture our products as inventories when the related costs are expected to be recoverable through the commercialization of the product. VONJO inventory that is deployed for clinical, research or development purposes is charged to research and development expense. |
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 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 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 |
Intangible Assets | We review for impairment when events or circumstances indicate that the carrying value of intangible assets may not be recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset and its eventual disposition are less than its carrying amount. Such estimated undiscounted future cash flows are derived from projected sales of VONJO and other competitive factors. The amount of impairment is measured as the difference between the carrying amount and the fair value of the impaired asset. |
Revenue Recognition | Net Product Sales On February 28, 2022, the FDA granted Accelerated Approval of VONJO 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 March 2022. We entered into a limited number of distribution arrangements with specialty distributors and specialty pharmacies in the United States to distribute VONJO . Our specialty pharmacy customers resell VONJO directly to patients while our specialty distributor customers resell VONJO to healthcare entities, who then resell to patients. Such specialty distributors and specialty pharmacies are referred to as our customers in the context of ASC 606. We recognize revenue for product sales when our customers obtain control of the product, which generally occurs upon delivery. Upon receipt of the product by our customers, we recognize revenues net of variable consideration, which relates to allowances for customer credits, distribution service fees, product returns, chargebacks, rebates and co-payment assistance programs as discussed below. The reserves for these allowances are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than the customer). Taxes collected from the customer relating to product sales and remitted to governmental authorities are excluded from product sales. Customer Credits and Distribution Service Fees : Our customers are offered prompt payment discounts. We expect our customers will pay timely enough to utilize prompt payment discounts and therefore we deduct the full amount of these discounts from total product sales when revenues are recognized. In addition, we pay a fee to our customers for their sales order management, data, and distribution services to us. Distribution service fees are also deducted from total product sales as they are incurred. Returns : We offer our customers and other indirect purchasers a limited right of return for purchased units of VONJO for damaged, defective, in-dated or expired product beginning six months prior to the product’s expiration date and ending 12 months after the product’s expiration date. As we do not have sufficient historical experience with VONJO sales, we estimate the amount of product returns initially based on data from similar products and other qualitative considerations, such as visibility into the inventory remaining in the distribution channel. Chargebacks : Chargebacks result from our contractual commitments to provide our product to discount-eligible healthcare entities, group purchasing organizations, 340B eligible covered entities and federal government entities purchasing via the Federal Supply Schedule, at prices lower than the list prices charged to our customers. Our customers charge us back for the discount provided to the contracted entities. Our reserves for chargebacks consist of credits that we expect to issue for units that remain in the distribution channel inventory, which we expect will be sold to the contracted entities, as well as chargebacks that customers have claimed, but for which we have not yet issued a credit. We record reserves for chargebacks based on contractual terms in the same period that the related revenue is recognized. Rebates : We are subject to discount and rebate obligations under government programs such as the Medicaid Drug Rebate Program, the Medicare Part D Coverage Gap Discounts Program and the 340B Drug Pricing Program, as well as under commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory or contractual discount rates and expected utilization. Our estimates for the expected utilization of rebates are based on data received from our customers and historical utilization rates observed subsequent to product launch. Our accrual for these rebates consists of invoices received for claims from prior and current quarters that have not been paid or for which an invoice has not yet been received as well as estimates of claims for the current period's shipment to our customers, which include estimated future claims that will be made for product that has been recognized as revenue but which remains in distribution channel inventories at the end of the reporting period. |
Cost of Sales | Cost of Sales Cost of sales includes the cost of manufacturing inventories that are related to product sales, including overhead costs, amortization expense for intangible assets, and third-party royalties payable on net product sales. In addition, shipping and handling costs for product shipments are recorded in cost of sales as incurred. Cost of sales may also include costs related to |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred in accordance with ASC 730, Research and Development |
Advertising | AdvertisingAdvertising costs are expensed as incurred. |
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. |
Income Taxes | 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. Future realization of deferred tax assets is dependent upon a number of factors, including the existence of sufficient taxable income based on future earnings, the timing and amount of which is uncertain. The assessment regarding whether a valuation allowance is required considers the evaluation of both positive and negative evidence when concluding whether it is more likely than not that deferred tax assets are realizable. Based upon a review of all available evidence, we determined that it is not more likely than not that the U.S. deferred tax assets will be realized, and therefore the deferred tax assets have been fully offset by a valuation allowance. |
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 stock options, warrants and restricted stock, using the treasury stock method, as their inclusion would have an anti-dilutive effect. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In March 2020, the Financial Accounting Standards Board, or the FASB, issued 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 8. Debt Financing Arrangements”, in August 2021, we entered into the 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 reference rate occurs. We do not expect the adoption of this guidance to have a material impact on our 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 financial statements. |
Description of Business and S_3
Description of Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedules of Concentration of Risk | The following table presents each customer that accounted for more than 10% of total net product sales for the year ended December 31, 2022: December 31, 2022 Customer A 30 % Customer B 23 % Customer C 21 % Customer D 17 % |
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, 2022 December 31, 2021 Cost or Amortized Cost Gross Unrealized Losses Fair Value Fair Value Cash $ 337 $ — $ 337 $ 137 Level 1 securities: Money market funds 30,083 — 30,083 65,309 Level 2 securities: Corporate debt securities 49,554 (35) 49,519 — Total cash, cash equivalents and short-term investments $ 79,974 $ (35) $ 79,939 $ 65,446 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Raw materials $ 156 $ — Work-in-process 496 — Finished goods 81 — Total inventories $ 733 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Furniture and office equipment $ 597 $ 597 Leasehold improvements 1,755 5,140 2,352 5,737 Less: accumulated depreciation and amortization (2,352) (5,561) Property and equipment, net $ — $ 176 |
Other Assets (Tables)
Other Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Other Assets | Other assets consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Right-of-use assets $ 2,078 $ 3,109 Prepaid manufacturing 855 — Clinical trial deposits 370 770 Total other assets $ 3,303 $ 3,879 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Milestone payment due to Takeda Pharmaceutical Company Limited (1) $ 10,291 $ — Employee compensation and related expenses 7,207 4,783 Clinical trial expenses 5,256 4,053 Royalty expenses 2,446 — Commercial expenses 2,424 3,075 Accrued rebates 1,289 — Other 489 809 Total accrued expenses $ 29,402 $ 12,720 (1) See “Note 10. Collaboration, Licensing and Milestone Agreements - Baxalta ” |
Other Current Liabilities (Tabl
Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Liabilities Disclosure [Abstract] | |
Components of Other Liabilities | Other current liabilities consisted of the following as of December 31, 2022 and 2021 (in thousands): 2022 2021 Operating lease liabilities - current $ 781 $ 1,160 End-of-facility lender fee (1) 1,000 1,000 Other current obligations — 500 Total other current liabilities $ 1,781 $ 2,660 (1) The end-of-facility lender fee as of December 31, 2022 and 2021 represents an amount payable to DRI, upon repayment of our secured term loan under the Credit Agreement with DRI. See “Note 8. Debt Financing Arrangements” for additional information. |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Components of Lease Expenses and Supplemental Information | The components of lease expense, which were included in our statements of operations, were as follows (in thousands): Year Ended December 31, 2022 2021 Operating lease expense $ 1,208 $ 1,586 Variable lease expense 50 183 Sublease income (415) (1,254) Total lease expense, net $ 843 $ 515 Supplemental information relating to our operating leases is as follows (in thousands): December 31, 2022 Supplemental cash flow information Cash paid for amounts included in the measurement of lease liabilities $ 1,450 Weighted-average remaining lease term of operating leases (years) 2.33 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, 2022 Right-of-use assets (included in Other Assets ) $ 2,078 Operating lease liabilities, current (included in Other current liabilities ) $ 781 Operating lease liabilities, non-current (included in Other liabilities, less current portion ) 1,234 Total lease liabilities $ 2,015 |
Schedule of Future Minimum Operating Lease Payments and Receivables | As of December 31, 2022, the maturities of operating lease liabilities were as follows (in thousands): Operating Lease Payments 2023 $ 975 2024 1,002 2025 337 Thereafter — Total payments 2,314 Less imputed interest (299) Total lease liabilities $ 2,015 |
Schedule of Future Minimum Operating Lease Payments and Receivables | As of December 31, 2022, the maturities of operating lease liabilities were as follows (in thousands): Operating Lease Payments 2023 $ 975 2024 1,002 2025 337 Thereafter — Total payments 2,314 Less imputed interest (299) Total lease liabilities $ 2,015 |
Debt Financing Agreements (Tabl
Debt Financing Agreements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Principal and Interest Payments of Debt | As of December 31, 2022, the scheduled principal and interest payments (based on the interest rate of 13.06% as of December 31, 2022) as well as the back-end fee described above are as follows (in thousands): Principal Interest Back-end fee Total 2023 $ — $ 6,622 $ — $ 6,622 2024 — 6,640 — 6,640 2025 — 6,622 — 6,622 2026 and thereafter 50,000 4,282 1,000 55,282 Total scheduled payments $ 50,000 $ 24,166 $ 1,000 $ 75,166 Less: debt discount and issuance costs (2,057) Current portion of long-term debt $ 47,943 |
Schedule of Debt | The activities related to the royalty financing obligation for the year ended December 31, 2022 were as follows (in thousands): Royalty financing obligation - initial funding $ 60,000 Less: debt issuance costs (1,814) Royalty financing obligation - beginning balance $ 58,186 Accretion of imputed interest on the royalty financing obligation balance 8,001 Amortization of debt issuance costs 126 Less: Royalty payments made to DRI (3,155) Less: Royalty payable to DRI (classified in accrued expenses) (2,024) Royalty financing obligation - ending balance $ 61,134 |
Equity Transactions (Tables)
Equity Transactions (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Summary of Common Stock Reserved for Issuance | As of December 31, 2022, we had 266.5 million authorized shares of common stock, of which 130.7 million shares were issued and outstanding, and 53.2 million shares were available for future issuances. The remaining authorized shares were reserved as follows (in thousands): Equity incentive plans 26,278 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) 2,676 Employee stock purchase plan 831 At-the-market equity program 15,006 Convertible preferred stock 36,470 Common stock purchase warrants 169 Total common stock reserved 82,550 |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 and 2021, which was allocated as follows (in thousands): 2022 2021 Research and development $ 1,291 $ 758 Selling, general and administrative 8,739 3,985 Total equity-based compensation expense $ 10,030 $ 4,743 |
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, 2022 2021 Risk-free interest rate 2.0 % 0.8 % Expected dividend yield None None Expected life (in years) 5.5 5.2 Volatility 84 % 101 % |
Stock Option Activity for All Stock Plans | The following table summarizes stock option activity during the year ended December 31, 2022: Options Weighted Weighted Aggregate Outstanding at December 31, 2021 (11,776,000 exercisable) 20,691,000 $ 2.31 Granted 5,037,000 $ 4.52 Exercised (3,600,000) $ 1.48 $ 15,900 Forfeited (530,000) $ 3.40 Cancelled and expired (81,000) $ 2.66 Outstanding at December 31, 2022 (13,417,000 exercisable) 21,517,000 $ 2.94 7.0 $ 67,705 Vested or expected to vest at December 31, 2022 20,558,000 $ 2.90 6.9 $ 65,584 Exercisable at December 31, 2022 13,417,000 $ 2.51 5.9 $ 48,549 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share | The computation of net loss per share is as follows (in thousands, except per share amounts): Year Ended December 31, 2022 2021 Net loss $ (92,992) $ (97,908) Basic and diluted: Weighted average common shares outstanding used in calculation of basic and diluted net loss per common share 114,694 90,117 Net loss per common share: Basic and diluted $ (0.81) $ (1.09) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes | The following table presents U.S. and foreign components of loss before income taxes (in thousands): Year ended December 31, 2022 2021 United States $ (92,992) $ (97,908) Foreign — — Net loss before income taxes $ (92,992) $ (97,908) |
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: 2022 2021 Federal income tax rate 21 % 21 % State income tax rate 11 — Research and development tax credits 1 5 Equity-based compensation 1 (1) Valuation allowance (47) (24) Adjustment of tax attributes 13 — Unrecognized tax benefits — (1) 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): 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 55,984 $ 40,061 Capitalized research and development 38,830 35,910 Royalty financing obligation 14,989 — Research and development tax credit carryforwards 13,942 5,386 Intangible assets 6,421 7,026 Equity-based compensation 4,827 3,337 Accrued liabilities and allowances 1,206 — Lease liability 494 670 Depreciation and amortization 316 785 Other deferred tax assets 3 231 Total deferred tax assets 137,012 93,406 Less: valuation allowance (136,051) (92,395) 961 1,011 Deferred tax liabilities: Right-of-use asset (509) (656) Other deferred tax liabilities (452) (355) Total deferred tax liabilities (961) (1,011) 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): 2022 2021 Balance at beginning of period $ 1,209 $ 390 Gross increases to tax positions in prior periods 1,353 — Gross decreases to tax positions in current periods — — Gross increases to tax positions in current periods 261 819 Balance at end of period $ 2,823 $ 1,209 |
Description of Business and S_4
Description of Business and Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2022 USD ($) | Mar. 01, 2022 | Jan. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) product | Dec. 31, 2021 USD ($) | |
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Number Of Commercially Approved Products | product | 1 | ||||
Accumulated deficit | $ 2,518,907 | $ 2,518,907 | $ 2,425,915 | ||
Available cash and cash equivalents | $ 79,939 | 79,939 | 65,446 | ||
Advertising cost | 14,800 | 0 | |||
VONJO | Subsequent Event | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Sales threshold achievement, additional funding received | $ 6,500 | ||||
Drug Royalty III LP 2 Credit Agreement | Secured Debt | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Liquidity covenant | $ 10,000 | ||||
Patented Technology | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Patent useful life | 11 years 10 months 24 days | ||||
Remaining amortization period | 11 years | 11 years 9 months 18 days | 11 years | ||
Amortization expense | $ 1,800 | $ 2,100 | |||
Carrying value | $ 25,000 | 25,000 | |||
Accumulated amortization | $ 1,800 | $ 1,800 | |||
Minimum | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Credit term | 30 days | 30 days | |||
Maximum | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Credit term | 66 days | 66 days |
Description of Business and S_5
Description of Business and Summary of Significant Accounting Policies - Schedules of Concentration of Risk (Details) - Customer Concentration Risk - Revenue Benchmark | 12 Months Ended |
Dec. 31, 2022 | |
Customer A | |
Product Information [Line Items] | |
Percentage of product sales | 30% |
Customer B | |
Product Information [Line Items] | |
Percentage of product sales | 23% |
Customer C | |
Product Information [Line Items] | |
Percentage of product sales | 21% |
Customer D | |
Product Information [Line Items] | |
Percentage of product sales | 17% |
Description of Business and S_6
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, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Abstract] | ||
Cash and cash equivalents | $ 337 | $ 137 |
Total cash, cash equivalents and short-term investments, amortized cost | 79,974 | |
Total cash, cash equivalents and short-term investments, gross unrealized losses | (35) | |
Total cash, cash equivalents and short-term investments | 79,939 | 65,446 |
Level 1 | Money market funds | ||
Debt Securities, Available-for-sale [Abstract] | ||
Cash and cash equivalents | 30,083 | 65,309 |
Level 2 | Corporate debt securities | ||
Debt Securities, Available-for-sale [Abstract] | ||
Cost or Amortized Cost | 49,554 | |
Gross Unrealized Gains / (Losses) | (35) | |
Fair Value | $ 49,519 | $ 0 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 156 | $ 0 |
Work-in-process | 496 | 0 |
Finished goods | 81 | 0 |
Total inventories | $ 733 | $ 0 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 2,352 | $ 5,737 |
Less: accumulated depreciation and amortization | (2,352) | (5,561) |
Property and equipment, net | 0 | 176 |
Depreciation expense | 200 | 500 |
Furniture and office equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 597 | 597 |
Leasehold improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,755 | $ 5,140 |
Other Assets (Details)
Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Right-of-use assets | $ 2,078 | $ 3,109 |
Prepaid manufacturing | 855 | 0 |
Clinical trial deposits | 370 | 770 |
Other assets | $ 3,303 | $ 3,879 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Milestone payment due to Takeda Pharmaceutical Company Limited | $ 10,291 | $ 0 |
Employee compensation and related expenses | 7,207 | 4,783 |
Clinical trial expenses | 5,256 | 4,053 |
Royalty expenses | 2,446 | 0 |
Commercial expenses | 2,424 | 3,075 |
Accrued rebates | 1,289 | 0 |
Other | 489 | 809 |
Total accrued expenses | $ 29,402 | $ 12,720 |
Other Current Liabilities (Deta
Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Liabilities Disclosure [Abstract] | ||
Operating lease liabilities - current | $ 781 | $ 1,160 |
End-of-facility lender fee | 1,000 | 1,000 |
Other current obligations | 0 | 500 |
Total other current liabilities | $ 1,781 | $ 2,660 |
Leases - Additional Information
Leases - Additional Information (Detail) ft² in Thousands, $ in Thousands | 1 Months Ended | ||
Dec. 31, 2021 USD ($) ft² Option | Apr. 30, 2022 ft² | May 31, 2012 ft² | |
Leases [Abstract] | |||
Area of office spaces | ft² | 23 | 44 | 66 |
Lease term | 10 years | ||
Lease extended term | 3 years | ||
Allowance for tenant improvements | $ 50 | ||
Number of options to extend the term | Option | 1 | ||
Extend option term | 5 years | ||
Increase in right-of-use asset balance | $ 2,400 | ||
Increase in lease liability balance | $ 2,400 |
Leases - Components of Lease Ex
Leases - Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | ||
Operating lease expense | $ 1,208 | $ 1,586 |
Variable lease expense | 50 | 183 |
Sublease income | (415) | (1,254) |
Total lease expense, net | $ 843 | $ 515 |
Leases - Balance Sheet Classifi
Leases - Balance Sheet Classification of Operating Lease Components (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Right-of-use assets (included in Other Assets) | $ 2,078 | $ 3,109 |
Operating lease liabilities, current (included in Other current liabilities) | 781 | $ 1,160 |
Operating lease liabilities, non-current (included in Other liabilities, less current portion) | 1,234 | |
Total lease liabilities | $ 2,015 | |
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 | Other Liabilities, Noncurrent |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments Under Noncancelable Operating Leases (Detail) $ in Thousands | Dec. 31, 2022 USD ($) |
Operating Leases Future Minimum Payments | |
2023 | $ 975 |
2024 | 1,002 |
2025 | 337 |
Thereafter | 0 |
Total payments | 2,314 |
Less imputed interest | (299) |
Total lease liabilities | $ 2,015 |
Leases - Supplemental Informati
Leases - Supplemental Information Relating to Operating Leases (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Leases [Abstract] | |
Cash paid for amounts included in the measurement of lease liabilities | $ 1,450 |
Weighted-average remaining lease term of operating leases (years) | 2 years 3 months 29 days |
Weighted-average discount rate of operating leases | 11.60% |
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, 2022 | |
Debt Instrument [Line Items] | ||
Number of days to deliver audited financial statements after each fiscal year | 120 days | |
Royalty financing obligation - initial funding | $ 50,000 | |
Drug Royalty III LP 2 Credit Agreement | Secured Debt | ||
Debt Instrument [Line Items] | ||
Principal amount | $ 50,000 | |
Exit fee | 2% | |
Debt covenant, required cash on hand | $ 10,000 | |
Royalty financing obligation - initial funding | 50,000 | |
Debt discount | 1,500 | 1,100 |
Debt issuance costs | $ 1,300 | |
Debt issuance costs, unamortized | $ 1,000 | |
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 | 13.06% |
Debt Financing Agreements - Pri
Debt Financing Agreements - Principal and Interest Payments of Debt (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Principal | |
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 | (2,057) |
Current portion of long-term debt | 47,943 |
Interest | |
Scheduled payments, Interest, 2023 | 6,622 |
Scheduled payments, Interest, 2024 | 6,640 |
Scheduled payments, Interest, 2025 | 6,622 |
Scheduled payments, Interest, 2026 and thereafter | 4,282 |
Total scheduled payments, Interest | 24,166 |
Back-end fee | |
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, 2023 | 6,622 |
Total scheduled payments, 2024 | 6,640 |
Total scheduled payments, 2025 | 6,622 |
Total scheduled payments, 2026 and thereafter | 55,282 |
Total scheduled payments | $ 75,166 |
Debt Financing Agreement - Roya
Debt Financing Agreement - Royalty Financing Agreement (Details) $ in Thousands | 1 Months Ended | 10 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2022 USD ($) | Mar. 01, 2022 | Jan. 31, 2023 USD ($) | Aug. 31, 2021 USD ($) day | Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Mar. 31, 2022 USD ($) | Mar. 07, 2022 USD ($) | |
Debt Instrument [Line Items] | |||||||||
Purchase price | $ 85,000 | ||||||||
Upfront purchase price | $ 50,000 | $ 50,000 | $ 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% | ||||||||
Imputed interest expense on royalty financing obligation | $ 8,001 | $ 0 | |||||||
Patented Technology | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining amortization period | 11 years | 11 years 9 months 18 days | 11 years | ||||||
Royalty Financing Agreement | Notes Payable | |||||||||
Debt Instrument [Line Items] | |||||||||
Upfront purchase price | $ 60,000 | $ 60,000 | |||||||
Debt issuance costs | $ 1,800 | 1,800 | $ 1,800 | $ 1,814 | |||||
Debt issuance costs, unamortized | $ 1,700 | $ 1,700 | $ 1,700 | ||||||
Interest rate | 18.80% | 18.80% | 18.80% | ||||||
Imputed interest expense on royalty financing obligation | $ 8,001 | $ 8,000 | |||||||
Royalty Financing Agreement | Notes Payable | Subsequent Event | |||||||||
Debt Instrument [Line Items] | |||||||||
Sales threshold achievement, additional funding received | $ 6,500 | ||||||||
Pending sales threshold achievement, maximum funding available | 18,500 | ||||||||
VONJO | |||||||||
Debt Instrument [Line Items] | |||||||||
Sales threshold required to eliminate negative covenant | $ 200,000 | ||||||||
VONJO | Subsequent Event | |||||||||
Debt Instrument [Line Items] | |||||||||
Sales threshold achievement, additional funding received | $ 6,500 | ||||||||
Tier One | VONJO | |||||||||
Debt Instrument [Line Items] | |||||||||
Annual net sales | 9.60% | ||||||||
Annual net sales, upper 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% | ||||||||
Annual net sales, lower limit | $ 400,000 |
Debt Financing Arrangements - R
Debt Financing Arrangements - Royalty Financing Obligation Activity (Details) - USD ($) $ in Thousands | 10 Months Ended | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2022 | Mar. 07, 2022 | |
Debt Instrument [Line Items] | |||||
Royalty financing obligation - initial funding | $ 50,000 | $ 50,000 | |||
Debt Rollforward [Roll Forward] | |||||
Royalty financing obligation - beginning balance | 47,943 | 47,943 | |||
Accretion of imputed interest on the royalty financing obligation balance | 8,001 | $ 0 | |||
Royalty financing obligation - ending balance | 47,943 | 47,943 | |||
Royalty Financing Agreement | Notes Payable | |||||
Debt Instrument [Line Items] | |||||
Royalty financing obligation - initial funding | $ 60,000 | $ 60,000 | |||
Less: debt issuance costs | (1,800) | (1,800) | (1,814) | ||
Debt Rollforward [Roll Forward] | |||||
Royalty financing obligation - beginning balance | 61,134 | 61,134 | 58,186 | ||
Accretion of imputed interest on the royalty financing obligation balance | 8,001 | 8,000 | |||
Amortization of debt issuance costs | 126 | ||||
Less: Royalty payments made to DRI | (3,155) | ||||
Less: Royalty payable to DRI (classified in accrued expenses) | (2,024) | (2,024) | |||
Royalty financing obligation - ending balance | $ 61,134 | $ 61,134 | $ 58,186 |
Equity Transactions - At-The-Ma
Equity Transactions - At-The-Market Equity Offering (Details) shares in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Aug. 31, 2022 USD ($) day | Jan. 31, 2021 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) shares | |
At-The Market Equity Offering | ||||
Class of Stock [Line Items] | ||||
Gross proceeds from offering | $ 45.5 | |||
Sale of stock, agent commissions | 1.4 | |||
August 2022 Sale Agreement | ||||
Class of Stock [Line Items] | ||||
Gross proceeds from offering | 9.7 | |||
Sale of stock, agent commissions | $ 0.3 | |||
Common Stock | At-The Market Equity Offering | ||||
Class of Stock [Line Items] | ||||
Expected proceeds from common stock offering, net of issuance costs | $ 50 | |||
Shares available for future conversion (in shares) | shares | 9.4 | |||
Common Stock | January 2021 Sale Agreement | ||||
Class of Stock [Line Items] | ||||
Expected proceeds from common stock offering, net of issuance costs | $ 50 | |||
Common Stock | August 2022 Sale Agreement | ||||
Class of Stock [Line Items] | ||||
Expected proceeds from common stock offering, net of issuance costs | $ 100 | |||
Shares available for future conversion (in shares) | shares | 1.7 | |||
Number of trading days | day | 1 | |||
Number of trading day's prior notice | day | 1 | |||
Percent of gross proceeds, underwriter commission | 3% | |||
Remaining Available Proceeds From Issuance Of Common Stock | $ 90 |
Equity Transactions - Series O
Equity Transactions - Series O Preferred Stock (Details) - shares | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Feb. 28, 2018 | Dec. 31, 2022 | |
Common Stock | |||
Class Of Warrant Or Right [Line Items] | |||
Stock Issued (in shares) | 15,700,000 | ||
CTI Biopharma Corp. | BVF Partners, L.P. | |||
Class Of Warrant Or Right [Line Items] | |||
Percentage of common stock owned by others | 27.10% | ||
CTI Biopharma Corp. | BVF Partners, L.P. | Common Stock | |||
Class Of Warrant Or Right [Line Items] | |||
Percentage of common stock owned by others | 5.30% | ||
CTI Biopharma Corp. | BVF Partners, L.P. | Preferred Stock | |||
Class Of Warrant Or Right [Line Items] | |||
Percentage of common stock owned by others | 21.80% | ||
Series O Preferred Stock | |||
Class Of Warrant Or Right [Line Items] | |||
Number of shares converted (in shares) | 12,575 | ||
Shares issued upon conversion of share (in shares) | 8,400,000 | ||
BVF Partners L.P. | Series O Preferred Stock | |||
Class Of Warrant Or Right [Line Items] | |||
Stock Issued (in shares) | 12,575 |
Equity Transactions - Series X
Equity Transactions - Series X Preferred Stock (Details) - shares | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Series X Preferred Stock | |||
Class Of Warrant Or Right [Line Items] | |||
Stock Issued (in shares) | 4,429 | ||
Number of shares converted (in shares) | 747 | ||
Shares issued upon conversion of share (in shares) | 7,500,000 | ||
Preferred stock outstanding (in shares) | 3,047 | 3,794 | |
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 - Common St
Equity Transactions - Common Stock Authorized (Details) - shares | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | May 31, 2021 | |
Equity [Abstract] | ||||
Common stock authorized (in shares) | 266,500,000 | 266,500,000 | 266,500,000 | 166,500,000 |
Common stock, increase in authorized shares (in shares) | 0 |
Equity Transactions - Common _2
Equity Transactions - Common Stock Reserved (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | May 31, 2021 |
Class of Stock [Line Items] | ||||
Common stock authorized (in shares) | 266,500,000 | 266,500,000 | 266,500,000 | 166,500,000 |
Common stock issued (in shares) | 130,747,161 | 99,763,922 | ||
Common stock outstanding (in shares) | 130,747,161 | 99,763,922 | ||
Common stock available for future issuance (in shares) | 53,200,000 | |||
Total common stock reserved (in shares) | 82,550,000 | |||
Warrant | ||||
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) | 36,470,000 | |||
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) | 2,676,000 | |||
Equity incentive plans | ||||
Class of Stock [Line Items] | ||||
Total common stock reserved (in shares) | 26,278,000 | |||
Employee stock purchase plan | ||||
Class of Stock [Line Items] | ||||
Total common stock reserved (in shares) | 831,000 | |||
At-the-market equity program | ||||
Class of Stock [Line Items] | ||||
Total common stock reserved (in shares) | 15,006,000 |
Equity Transactions - Warrants
Equity Transactions - Warrants (Details) - Loan and Security Agreement - Warrant | Dec. 31, 2022 $ / shares shares |
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 Thousands | Feb. 28, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Oct. 31, 2016 | May 31, 2012 | Jun. 30, 2005 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Contingency milestone payment to be made | $ 10,291 | $ 0 | ||||
S_BIO Asset Purchase Agreement | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Milestone payments through the issuance of stock | 50% | |||||
S_BIO Asset Purchase Agreement | S*Bio | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Contingency milestone payable | $ 25,000 | |||||
Contingent milestone payment to be made | $ 132,500 | |||||
Collaborative Arrangement | Teva Pharmaceutical Industries Ltd | Products | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Contingency milestone payment to be received | $ 100,000 | |||||
Milestone payments earned | $ 60,000 | |||||
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 | $ 10,300 | |||||
Borrowing Associated With License Agreement | Asset Return and Termination Agreement | Takeda | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Contingency milestone payable | $ 10,300 | |||||
Milestone payment term | 60 days | |||||
Milestone payment interest | $ 500 | |||||
Milestone payment | $ 10,300 |
Equity-Based Compensation - Sum
Equity-Based Compensation - Summary of Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Equity-based compensation expense | $ 10,030 | $ 4,743 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Equity-based compensation expense | 1,291 | 758 |
Selling, general and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Equity-based compensation expense | $ 8,739 | $ 3,985 |
Equity-Based Compensation - Add
Equity-Based Compensation - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||
Mar. 20, 2017 | May 31, 2017 | Mar. 31, 2017 installment $ / shares shares | Dec. 31, 2022 USD ($) offering $ / shares shares | Dec. 31, 2021 USD ($) $ / shares | Jun. 30, 2022 shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Unrecognized compensation cost | $ | $ 13,000,000 | |||||
Recognition period | 2 years 3 months 3 days | |||||
Tax benefits attributed to share-based compensation expense | $ | $ 0 | $ 0 | ||||
Shares of common stock reserved for future issuance (in shares) | 82,550,000 | |||||
Stock offerings per year | offering | 2 | |||||
Length of offerings | 6 months | |||||
Equity-based compensation expense | $ | $ 10,030,000 | $ 4,743,000 | ||||
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) | 2,700,000 | |||||
Exercise price of options granted (in dollars per share) | $ / shares | $ 3.25 | |||||
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) | 32,500,000 | |||||
Shares available for future grants (in shares) | 8,500,000 | |||||
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 | |||||
Employee stock purchase plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares of common stock reserved for future issuance (in shares) | 831,000 | |||||
Equity-based compensation expense | $ | $ 700,000 | |||||
Stock Options | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Exercise price of options granted (in dollars per share) | $ / shares | $ 4.52 | |||||
Weighted average exercise price of options exercisable (in dollars per share) | $ / shares | 2.51 | $ 2.39 | ||||
Weighted average fair value of options granted (in USD per share) | $ / shares | $ 3.14 | $ 2.07 | ||||
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) | 8,000,000 | |||||
Employee stock | Employee stock purchase plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares of common stock reserved for future issuance (in shares) | 800,000 | 500,000 | ||||
Shares authorized for issuance (in shares) | 1,500,000 | |||||
Purchase price of common stock, percentage of fair market value | 85% | |||||
Shares issued in period (in shares) | 500,000 |
Equity-Based Compensation - Wei
Equity-Based Compensation - Weighted Average Assumptions (Detail) - Stock Options | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 2% | 0.80% |
Expected dividend yield | 0% | 0% |
Expected life (in years) | 5 years 6 months | 5 years 2 months 12 days |
Volatility | 84% | 101% |
Equity-Based Compensation - Sto
Equity-Based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Weighted Average Exercise Price | ||
Aggregate Intrinsic Value, Exercised at end of period | $ 15,900 | |
Stock Options | ||
Options | ||
Options, Beginning Balance (in shares) | 20,691,000 | |
Options, Granted (in shares) | 5,037,000 | |
Options, Exercised (in shares) | (3,600,000) | |
Options, Forfeited (in shares) | (530,000) | |
Options, Cancelled and expired (in shares) | (81,000) | |
Options, Ending Balance (in shares) | 21,517,000 | |
Options, Vested or expected to vest (in shares) | 20,558,000 | |
Options, Exercisable (in shares) | 13,417,000 | 11,776,000 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Beginning balance (in dollars per share) | $ 2.31 | |
Weighted Average Exercise Price, Granted (in dollars per share) | 4.52 | |
Weighted Average Exercise Price, Exercised (in dollars per share) | 1.48 | |
Weighted Average Exercise Price, Forfeited (in dollars per share) | 3.40 | |
Weighted Average Exercise Price, Cancelled and expired (in dollars per share) | 2.66 | |
Weighted Average Exercise Price, Ending balance (in dollars per share) | 2.94 | |
Weighted Average Exercise Price, Vested or expected to vest (in dollars per share) | 2.90 | |
Weighted Average Exercise Price, Exercisable (in dollars per share) | $ 2.51 | $ 2.39 |
Weighted Average Remaining Contractual Term, Outstanding at end of period | 7 years | |
Weighted Average Remaining Contractual Term, Vested and expected to vest at end of period | 6 years 10 months 24 days | |
Weighted Average Remaining Contractual Term, Exercisable at end of period | 5 years 10 months 24 days | |
Aggregate Intrinsic Value, Outstanding at end of period | $ 67,705 | |
Aggregate Intrinsic Value, Vested and expected to vest at end of period | 65,584 | |
Aggregate Intrinsic Value, Exercisable at end of period | $ 48,549 |
Employee Benefit Plans (Detail)
Employee Benefit Plans (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Maximum percentage of annual contributions per employee | 80% | |
Discretionary matching contributions | $ 1.3 | $ 0.3 |
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, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Net loss available to common stockholders, basic | $ (92,992) | $ (97,908) |
Net loss available to common stockholders, diluted | $ (92,992) | $ (97,908) |
Basic and diluted: | ||
Weighted average common shares outstanding, basic (in shares) | 114,694 | 90,117 |
Weighted average common shares outstanding, diluted (in shares) | 114,694 | 90,117 |
Net loss per common share: Basic (in dollars per share) | $ (0.81) | $ (1.09) |
Net loss per common share: Diluted (in dollars per share) | $ (0.81) | $ (1.09) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares shares in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Anti-dilutive securities excluded from computation of let loss per share (in shares) | 68.8 | 74.5 |
Commitments and Contingencies (
Commitments and Contingencies (Detail) € in Millions, $ in Millions | 12 Months Ended | |||||||
Dec. 31, 2022 | Dec. 31, 2014 EUR (€) | Sep. 30, 2022 EUR (€) | Sep. 30, 2022 USD ($) | Apr. 30, 2022 EUR (€) | Dec. 31, 2007 EUR (€) | Dec. 31, 2006 EUR (€) | Dec. 31, 2003 EUR (€) | |
Loss Contingencies [Line Items] | ||||||||
Purchase commitment, minimum payment term | 1 year | |||||||
Purchase commitment, maximum payment term | 3 years | |||||||
VAT Assessments | ||||||||
Loss Contingencies [Line Items] | ||||||||
Estimate of possible loss | € 0.7 | € 0.9 | € 2.8 | € 0.7 | ||||
VAT liability | € 0.3 | $ 0.3 | ||||||
Deposits made to ITA | € 0.4 |
Income Taxes - Loss Before Inco
Income Taxes - Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (92,992) | $ (97,908) |
Foreign | 0 | 0 |
Net loss | $ (92,992) | $ (97,908) |
Income Taxes - Reconciliation B
Income Taxes - Reconciliation Between Effective and Income Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax rate | 21% | 21% |
State income tax rate | 11% | 0% |
Research and development tax credits | 1% | 5% |
Equity-based compensation | 1% | (1.00%) |
Valuation allowance | (47.00%) | (24.00%) |
Adjustment of tax attributes | 13% | 0% |
Unrecognized tax benefits | 0% | (1.00%) |
Net effective tax rate | 0% | 0% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 55,984 | $ 40,061 |
Capitalized research and development | 38,830 | 35,910 |
Royalty financing obligation | 14,989 | 0 |
Research and development tax credit carryforwards | 13,942 | 5,386 |
Intangible assets | 6,421 | 7,026 |
Equity-based compensation | 4,827 | 3,337 |
Accrued liabilities and allowances | 1,206 | 0 |
Lease liability | 494 | 670 |
Depreciation and amortization | 316 | 785 |
Other deferred tax assets | 3 | 231 |
Total deferred tax assets | 137,012 | 93,406 |
Less: valuation allowance | (136,051) | (92,395) |
Deferred tax assets, net, total | 961 | 1,011 |
Deferred tax liabilities: | ||
Right-of-use asset | (509) | (656) |
Other deferred tax liabilities | (452) | (355) |
Total deferred tax liabilities | (961) | (1,011) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of period | $ 1,209 | $ 390 |
Gross increases to tax positions in prior periods | 1,353 | 0 |
Gross decreases to tax positions in current periods | 0 | 0 |
Gross increases to tax positions in current periods | 261 | 819 |
Balance at end of period | $ 2,823 | $ 1,209 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax [Line Items] | |||
Net operating losses with an indefinite life | $ 209,800,000 | ||
Ownership interest period | 3 years | ||
Income tax of excess percentage | 50% | ||
Deferred tax asset, research and development provision | $ 7,300,000 | ||
Valuation allowance Increased | 43,700,000 | ||
Unrecognized tax benefits | 2,823,000 | $ 1,209,000 | $ 390,000 |
Accrued interest or penalties related to unrecognized tax benefits | 0 | ||
Domestic Tax Authority | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards (decrease) | 242,800,000 | 182,700,000 | |
U.S. federal tax credits | 16,800,000 | 5,400,000 | |
State and Local Jurisdiction | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards (decrease) | $ 43,200,000 | $ 15,000,000 |