Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 22, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | OTIC | ||
Entity Registrant Name | Otonomy, Inc. | ||
Entity Central Index Key | 0001493566 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 56,732,474 | ||
Entity Public Float | $ 96.6 | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-36591 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-2590070 | ||
Entity Address, Address Line One | 4796 Executive Drive | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | 619 | ||
Local Phone Number | 323-2200 | ||
ICFR Auditor Attestation Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE As noted herein, the information called for by Part III is incorporated by reference to specified portions of the registrant’s definitive proxy statement to be filed in conjunction with the registrant’s 2022 Annual Meeting of Stockholders, which is expected to be filed not later than 120 days after the registrant’s fiscal year ended December 31, 2021 . | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | San Diego, California | ||
Auditor Firm ID | 42 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 77,412 | $ 30,767 |
Short-term investments | 55,576 | |
Prepaid and other current assets | 3,056 | 2,372 |
Total current assets | 80,468 | 88,715 |
Restricted cash | 702 | 702 |
Property and equipment, net | 1,771 | 2,766 |
Right-of-use assets | 12,696 | 14,082 |
Total assets | 95,637 | 106,265 |
Current liabilities: | ||
Accounts payable | 1,090 | 849 |
Accrued expenses | 4,338 | 2,953 |
Accrued compensation | 3,450 | 3,927 |
Leases, current | 3,455 | 3,265 |
Total current liabilities | 12,333 | 10,994 |
Long-term debt, net | 15,997 | 15,158 |
Leases, net of current | 12,400 | 13,847 |
Total liabilities | 40,730 | 39,999 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2021 and 2020; no shares issued or outstanding at December 31, 2021 and 2020 | ||
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2021 and 2020; 56,732,474 and 48,318,970 shares issued and outstanding at December 31, 2021 and 2020, respectively | 57 | 48 |
Additional paid-in capital | 610,655 | 570,841 |
Accumulated other comprehensive income | 1 | |
Accumulated deficit | (555,805) | (504,624) |
Total stockholders’ equity | 54,907 | 66,266 |
Total liabilities and stockholders’ equity | $ 95,637 | $ 106,265 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares Issued | 56,732,474 | 48,318,970 |
Common stock, Shares outstanding | 56,732,474 | 48,318,970 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | |||
Product sales, net | $ 125 | $ 273 | $ 600 |
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Costs and operating expenses: | |||
Cost of product sales | $ 370 | $ 1,188 | $ 912 |
Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 34,673 | $ 27,997 | $ 32,805 |
Selling, general and administrative | 14,707 | 14,575 | 11,690 |
Total costs and operating expenses | 49,750 | 43,760 | 45,407 |
Loss from operations | (49,625) | (43,487) | (44,807) |
Other income (expense): | |||
Interest income | 43 | 326 | 1,723 |
Interest expense | (1,599) | (1,570) | (1,591) |
Total other (expense) income, net | (1,556) | (1,244) | 132 |
Net loss | $ (51,181) | $ (44,731) | $ (44,675) |
Net loss per share, basic and diluted | $ (0.81) | $ (1.10) | $ (1.45) |
Weighted-average shares used to compute net loss per share, basic and diluted | 63,441,330 | 40,845,844 | 30,726,786 |
Statements of Comprehensive Los
Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (51,181) | $ (44,731) | $ (44,675) |
Other comprehensive loss: | |||
Unrealized (loss) gain on available-for-sale securities | (1) | (10) | 34 |
Comprehensive loss | $ (51,182) | $ (44,741) | $ (44,641) |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2018 | $ 79,737 | $ 31 | $ 494,947 | $ (23) | $ (415,218) |
Beginning balance, shares at Dec. 31, 2018 | 30,685,412 | ||||
Issuance of common stock upon exercise of stock options | 5 | 5 | |||
Issuance of common stock upon exercise of stock options, shares | 2,912 | ||||
Issuance of common stock under employee stock purchase plan | 242 | 242 | |||
Issuance of common stock under employee stock purchase plan, shares | 125,887 | ||||
Stock-based compensation expense | 4,890 | 4,890 | |||
Net loss | (44,675) | (44,675) | |||
Unrealized (loss) gain on available-for-sale securities | 34 | 34 | |||
Ending balance at Dec. 31, 2019 | 40,233 | $ 31 | 500,084 | 11 | (459,893) |
Ending balance, shares at Dec. 31, 2019 | 30,814,211 | ||||
Issuance of common stock and pre-funded warrants, net of issuance costs | 64,187 | $ 17 | 64,170 | ||
Issuance of common stock and prefunded warrants, net of issuance costs (unaudited), shares | 17,275,000 | ||||
Issuance of common stock upon exercise of stock options | 206 | 206 | |||
Issuance of common stock upon exercise of stock options, shares | 92,035 | ||||
Issuance of common stock under employee stock purchase plan | 270 | 270 | |||
Issuance of common stock under employee stock purchase plan, shares | 137,724 | ||||
Stock-based compensation expense | 6,111 | 6,111 | |||
Net loss | (44,731) | (44,731) | |||
Unrealized (loss) gain on available-for-sale securities | (10) | (10) | |||
Ending balance at Dec. 31, 2020 | 66,266 | $ 48 | 570,841 | 1 | (504,624) |
Ending balance, shares at Dec. 31, 2020 | 48,318,970 | ||||
Issuance of common stock and pre-funded warrants, net of issuance costs | 32,207 | $ 9 | 32,198 | ||
Issuance of common stock and prefunded warrants, net of issuance costs (unaudited), shares | 8,298,890 | ||||
Issuance of common stock upon exercise of stock options | $ 6 | 6 | |||
Issuance of common stock upon exercise of stock options, shares | 3,000 | 2,836 | |||
Issuance of common stock under employee stock purchase plan | $ 213 | 213 | |||
Issuance of common stock under employee stock purchase plan, shares | 111,778 | ||||
Stock-based compensation expense | 7,397 | 7,397 | |||
Net loss | (51,181) | (51,181) | |||
Unrealized (loss) gain on available-for-sale securities | (1) | (1) | |||
Ending balance at Dec. 31, 2021 | $ 54,907 | $ 57 | $ 610,655 | $ 0 | $ (555,805) |
Ending balance, shares at Dec. 31, 2021 | 56,732,474 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | |||
Net loss | $ (51,181,000) | $ (44,731,000) | $ (44,675,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 856,000 | 1,062,000 | 1,149,000 |
Stock-based compensation | 7,397,000 | 6,111,000 | 4,890,000 |
Amortization of premiums (accretion of discounts) on short-term investments | 85,000 | (29,000) | (787,000) |
Amortization of debt discount | 172,000 | 191,000 | 189,000 |
Impairment of property and equipment | 727,000 | 0 | 0 |
Changes in operating assets and liabilities: | |||
Prepaid and other assets | (1,564,000) | 108,000 | 536,000 |
Accounts payable | 276,000 | (374,000) | 127,000 |
Accrued expenses | 1,459,000 | (2,419,000) | 1,656,000 |
Accrued compensation | (477,000) | 1,334,000 | (42,000) |
Right-of-use assets and lease liabilities, net | (168,000) | (127,000) | 32,000 |
Net cash used in operating activities | (42,418,000) | (38,874,000) | (36,925,000) |
Cash flows from investing activities: | |||
Purchases of short-term investments | 0 | (68,581,000) | (85,004,000) |
Maturities of short-term investments | 55,490,000 | 48,500,000 | 114,000,000 |
Purchases of property and equipment | (295,000) | (134,000) | (700,000) |
Proceeds from disposition | 768,000 | 0 | |
Net cash provided by (used in) investing activities | 55,963,000 | (20,215,000) | 28,296,000 |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs | 32,207,000 | 64,187,000 | |
Proceeds from issuance of long-term debt, net of cash issuance costs | 674,000 | ||
Proceeds from short-term debt | 1,126,000 | ||
Principal payments on short-term debt | (1,126,000) | ||
Proceeds from issuance of common stock under employee stock purchase plan | 213,000 | 270,000 | 242,000 |
Proceeds from exercise of stock options | 6,000 | 206,000 | 5,000 |
Payments of debt issuance costs | (52,000) | ||
Net cash provided by financing activities | 33,100,000 | 64,663,000 | 195,000 |
Net change in cash, cash equivalents and restricted cash | 46,645,000 | 5,574,000 | (8,434,000) |
Cash, cash equivalents and restricted cash at beginning of period | 31,469,000 | 25,895,000 | 34,329,000 |
Cash, cash equivalents and restricted cash at end of period | 78,114,000 | 31,469,000 | 25,895,000 |
Cash and cash equivalents at end of period | 77,412,000 | 30,767,000 | 25,194,000 |
Restricted cash at end of period | 702,000 | 702,000 | 701,000 |
Supplemental cash flow information: | |||
Cash paid for interest | 1,422,000 | 1,373,000 | 1,394,000 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Purchase of property and equipment in accounts payable and accrued expenses | $ 85,000 | $ 67,000 | $ 76,000 |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Description of Business Otonomy, Inc. (Otonomy or the Company) was incorporated in the state of Delaware on May 6, 2008. Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The Company pioneered the application of drug delivery technology to the ear and is utilizing that expertise and proprietary position to develop products that achieve sustained drug exposure from a single local administration. The Company’s primary focus is currently on the advancement of three programs in its broad pipeline: OTO-313 in Phase 2 for tinnitus; OTO-413 in Phase 2a for hearing loss; and OTO-825, a gene therapy for congenital hearing loss, in investigational new drug (IND)-enabling activities. Additionally, the Company is conducting preclinical development of OTO-510 for otoprotection and OTO-6XX for severe hearing loss. Basis of Presentation The Company follows Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements—Going Concern , which requires that management perform a two-step analysis over its ability to continue as a going concern. Management must first evaluate whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern and to meet its obligations as they become due within one year after the date that the financial statements are issued (step 1). If management concludes that substantial doubt is raised, management is also required to consider whether its plans alleviate that doubt (step 2). The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operating activities since inception. As of December 31, 2021, the Company had cash, cash equivalents and short-term investments of $ 77.4 million, outstanding debt of $ 16.0 million and an accumulated deficit of $ 555.8 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it: (i) develops and seeks regulatory approvals for its product candidates; and (ii) works to develop additional product candidates through research and development programs. When additional financing is required, the Company anticipates that it will seek additional funding through future debt and/or equity financings or other sources, such as potential collaboration agreements. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. If the Company is not able to secure adequate additional funding, if or when necessary, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects. The Company believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations for a period of at least twelve months from the date of this report. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of product sales and expense during the reporting period. Although these estimates are based on the Company’s knowledge of current events and anticipated actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institution in which those deposits are held. Additionally, the Company established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less at the date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments. Cash and cash equivalents include cash in readily available checking, savings and money market accounts. The Company’s restricted cash consists of cash maintained in separate deposit accounts to secure a letter of credit issued by a bank to the landlord under a lease agreement for the Company’s corporate headquarters. Short-term Investments From time to time, the Company carries short-term investments classified as available-for-sale debt securities at fair value as determined by prices for identical or similar securities at the balance sheet date. Short-term investments consist of Level 1 financial instruments in the fair value hierarchy (see Note 8 – Fair Value ). Realized gains or losses of available-for-sale securities are determined using the specific identification method and net realized gains and losses are included in interest income. The Company periodically reviews available-for-sale securities for other-than-temporary declines in fair value below the cost basis, and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company records unrealized gains and losses on available-for-sale debt securities as a component of other comprehensive loss within the statements of comprehensive loss and as a separate component of stockholders’ equity on the balance sheets. The Company does not hold equity securities in its investment portfolio. Fair Value of Financial Instruments The Company’s financial instruments include cash, cash equivalents, short-term investments, prepaid expenses and other assets, accounts payable, accrued expenses, accrued compensation and long-term debt. The carrying value of the Company’s cash and cash equivalents, short-term investments, prepaid expenses and other current assets, other long-term assets, accounts payable, accrued expenses, and accrued compensation approximate fair value due to the short-term nature of these items. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, the Company believes the fair value of long-term debt approximates its carrying value. Property and Equipment, Net Property and equipment generally consist of manufacturing equipment, office furniture and equipment, computers, and scientific equipment and are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally two to ten years ). Leasehold improvements are recorded at cost and are depreciated on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. During the year ended December 31, 2021, the Company recorded an impairment to property and equipment, net of $ 0.7 million. No impairment was recorded during the years ended December 31, 2020 and 2019. Repairs and maintenance costs are charged to expense as incurred. Impairment of Long-Lived Assets The Company assesses the value of its long-lived assets for impairment on an annual basis and whenever events indicate that the carrying amount of such assets may not be recoverable. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, the Company believes that future cash flows to be received support the carrying value of its long-lived assets. No impairment of long-lived assets was recorded during the years ended December 31, 2021, 2020 and 2019. Right-of-Use Assets and Lease Liabilities The Company has operating leases for its facility and certain equipment and finance leases for certain computer equipment. The Company determines if an arrangement is or contains a lease at each commencement date. Accounting Standards Codification (ASC) 842, Leases (ASC 842) establishes a right-of-use (ROU) model that requires a lessee to recognize an ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Accounting Standards Update (ASU) No. 2016-02, Leases (ASU 2016-02) provides a number of optional practical expedients and accounting policy elections. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. Operating leases are included in ROU assets, Leases, current, and Leases, net of current on the balance sheets. Finance leases are included in Property and equipment, Leases, current, and Leases, net of current on the balance sheets. The Company has elected a policy not to recognize short-term leases (one year or less) on the balance sheets. ROU assets and operating lease liabilities are recognized based on the present value of future minimum lease payments over the lease term at the commencement date. When the implicit rate of the lease is not provided or cannot be determined, the Company uses a collateralized incremental borrowing rate based on the information available at the commencement date, including lease term, in determining the present value of future payments. The Company considers payments for common area maintenance, real estate taxes and management fees to be variable non-lease components, which are expensed as incurred. Lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Clinical Trial Expense Accruals The Company estimates expenses resulting from its obligations under contracts with vendors, contract research organizations (CROs) and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided. The Company records clinical trial expenses in the period in which services are performed and efforts are expended. The Company accrues for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company estimates accruals through financial models taking into account discussion with applicable personnel and outside service providers as to the progress of trials. During the course of a clinical trial, the Company may adjust its clinical accruals if actual results differ from its estimates. Collaborative Arrangements The Company has entered into co-promotion agreements and research agreements that fall under the scope of ASC Topic 808, Collaborative Arrangements (ASC 808). Co-promotion agreements can include payments and reimbursements for a proportion of product support expenses to the Company and profit sharing payments by the Company. Payments to or by the Company are recognized in selling, general and administrative expenses in the statements of operations. Research agreements can include reimbursements to or by the Company, which are recognized in research and development expenses in the statements of operations. License Fees The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain, and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates would be reached when the requisite regulatory approvals are obtained to make the product available for sale. Research and Development Research and development expenses include the costs associated with the Company’s research and development activities, including salaries, benefits, stock-based compensation expense and occupancy costs. Also included in research and development expenses are third-party costs incurred in conjunction with contract manufacturing for the Company’s research and development programs and clinical trials, including the cost of clinical trial drug supply, costs incurred by CROs and regulatory expenses. Research and development costs are expensed as incurred. Selling, General and Administrative Selling, general and administrative expenses include the costs associated with the Company’s executive, administrative, finance and human resource functions including salaries, benefits, stock-based compensation expense and occupancy costs. Other selling, general and administrative expenses include costs associated with prosecuting and maintaining the Company’s patent portfolio, corporate legal expenses, costs required for public company activities and infrastructure necessary for the general conduct of the Company’s business. The Company’s selling, general and administrative expenses also include OTIPRIO product support expenses, and profit-sharing fees payable to the Company’s partners, which are reduced by payments received from the Company’s partners under its co-promotion agreements. Stock-Based Compensation The Company accounts for stock-based compensation expense related to stock options and employee stock purchase plan (ESPP) rights by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model, while market price of the Company’s common stock at the date of grant is used for restricted stock unit awards. Forfeitures are recognized as incurred. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized using the straight-line method. For performance-based awards to employees, (i) the fair value of the award is determined on the grant date, (ii) the Company assesses the probability of the individual performance milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. Income Taxes The accounting guidance for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities based on the technical merits of the position. The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. As of December 31, 2021, potentially dilutive securities excluded from the calculation of diluted net loss per share consist of outstanding options to purchase 11,707,568 shares of the Company’s common stock and 1,650,250 unvested restricted stock units. As of December 31, 2020 and 2019, potentially dilutive securities excluded from the calculation of diluted net loss per share consist of outstanding options to purchase 9,842,744 and 7,495,129 shares of the Company’s common stock, respectively. Risks and Uncertainties Related to COVID-19 In March 2020, the World Health Organization declared COVID-19 a global pandemic. The COVID-19 pandemic could pose significant risks to the Company’s business; however, the ultimate impact of the pandemic is highly uncertain. Given the unprecedented and evolving nature of the COVID-19 pandemic, including the rise of new variants, there continues to be significant uncertainty about the progression and ultimate impact of the pandemic on the Company’s operations. The Company has taken steps to mitigate the impact of the COVID-19 pandemic on its clinical trials, including developing processes to ensure the integrity of data collection from enrolled patients and supporting sites’ ability to enroll patients, among other activities. Nonetheless the Company does not know the full extent of potential future delays or impacts on its business operations, its preclinical programs and clinical trials, healthcare systems, its financial condition, or the global economy as a whole resulting from the COVID-19 pandemic. In addition, as a result of the COVID-19 pandemic, the Company has taken steps to protect the health and safety of its employees and community by following directives from the State of California and the applicable local governments, and guidance from the U.S. Centers for Disease Control and Prevention (CDC). Various safety protocols have been implemented and the Company is currently allowing employees who can remotely perform their essential functions to work from home. Recent Accounting Pronouncements Not Yet Adopted In June 2016, ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13) was issued, as amended. ASU 2016-13 introduces the current expected credit loss model, which will require an entity to measure credit losses for certain financial instruments and financial assets. ASU 2016-13 will also apply to receivables arising from revenue transactions such as accounts receivable. ASU 2016-13 is effective for the Company beginning January 1, 2023. The Company does not expect the adoption of ASU 2016-13 to have a material effect on its financial position, results of operations or cash flows. Recently Adopted Effective January 1, 2021, the Company early adopted ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (ASU 2020-06). ASU 2020-06 simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. There was no cumulative effect to be recognized in connection with the early adoption of ASU 2020-06 and the adoption did not have a material impact on the Company’s financial statements or disclosure s. |
Available-for-Sale Securities
Available-for-Sale Securities | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-Sale Securities | 3. Available-for-Sale Securities The Company invests in available-for-sale debt securities consisting of money market funds, certificates of deposit, U.S. Treasury securities and U.S. government sponsored enterprise securities. Available-for-sale debt securities are classified as part of either cash and cash equivalents or short-term investments in the balance sheets. Available-for-sale debt securities with maturities of three months or less from the date of purchase have been classified as cash equivalents, and were $ 71.5 million and $ 23.3 million as of December 31, 2021 and 2020, respectively. The Company held no available-for-sale debt securities with maturities of more than three months from the date of purchase as of December 31, 2021. Available-for-sale debt securities with maturities of more than three months from the date of purchase as of December 31, 2020 have been classified as short-term investments, and were as follows (in thousands): Amortized Unrealized Unrealized Market Value December 31, 2020: U.S. Treasury securities $ 55,085 $ 2 $ ( 1 ) $ 55,086 Certificates of deposit 490 — — 490 $ 55,575 $ 2 $ ( 1 ) $ 55,576 As of December 31, 2021 , the Company had no securities in a gross unrealized loss position. At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are other-than-temporary. Factors considered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, and the Company’s intent and ability to hold the investment until recovery of its amortized cost basis. The Company intends, and has the ability, to hold any investments in unrealized loss positions until their amortized cost basis has been recovered. The Company determined there were no other-than-temporary declines in the value of any available-for-sale securities as of December 31, 2021 . All the Company’s available-for-sale debt securities mature within one year . The Company obtains the fair value of its available-for-sale debt securities from a professional pricing service. The fair values of available-for-sale debt securities are validated by comparing the fair values reported by the professional pricing service to quoted market prices or to fair values obtained from the custodian bank. |
Balance Sheet Details
Balance Sheet Details | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | 4. Balance Sheet Details Property and Equipment, Net Property and equipment, net consists of the following (in thousands): December 31, 2021 2020 Laboratory equipment $ 4,252 $ 4,265 Manufacturing equipment 82 1,075 Computer equipment and software 1,488 989 Leasehold improvements 822 768 Office furniture 1,507 1,548 8,151 8,645 Less: accumulated depreciation ( 6,380 ) ( 5,879 ) Total $ 1,771 $ 2,766 Depreciation expense was $ 0.9 million, $ 1.1 million and $ 1.1 million for the years ended December 31, 2021, 2020 and 2019, respectively. Accrued Expenses Accrued expenses consist of the following (in thousands): December 31, 2021 2020 Accrued clinical trial costs $ 1,279 $ 1,477 Accrued other 3,059 1,476 Total $ 4,338 $ 2,953 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Operating Leases In December 2016, the Company moved into its current headquarters location in San Diego, California. The lease commenced in December 2016 and has an initial term of 130 months, with an option by the Company to extend the lease term for an additional five years . The Company has the right to terminate the lease at the end of the 94th month of the lease term if it is acquired by a third party and pays an early termination fee. The Company is responsible for payment of taxes and operating expenses for the building, in addition to monthly base rent in the initial amount of approximately $ 232,000 , with 3 % annual increases, which monthly base rent was abated for the first ten months of the lease term. The total estimated base rent payments over the life of the lease are estimated to be approximately $ 32.7 million. Upon execution of the lease in May 2015, the Company provided a security deposit in the form of a letter of credit in the amount of approximately $ 0.7 million. Cash collateralizing the letter of credit is classified as noncurrent restricted cash on the balance sheets. The Company has determined that the lease is an operating lease for accounting purposes. Intellectual Property Licenses The Company has acquired exclusive rights to develop patented rights, information rights and related know-how for OTO-311, OTO-313, OTO-413 and OTIVIDEX and potential future product candidates under licensing agreements with third parties. The licensing rights obligate the Company to make payments to the licensors for license fees, milestones and royalties. The Company is also responsible for patent prosecution costs, in the event such costs are incurred. The Company may be obligated to make additional milestone payments under the Company’s intellectual property license agreements covering OTO-313 and OTO-413 as follows (in thousands): Development $ 1,250 Regulatory 7,675 Commercialization 1,000 Total $ 9,925 The table above includes a potential milestone payment of $ 0.3 million under one of the Company’s license agreements payable if the Company initiates a Phase 2 trial for OTO-413 in 2022. In July 2020, the Company entered into an exclusive license agreement to develop, manufacture and commercialize a novel compound as a potential treatment, OTO-6XX, for severe hearing loss. Under the terms of the agreement, the Company acquired worldwide rights to the compound for an upfront payment of $ 0.5 million with an additional $ 0.5 million due upon demonstration of preclinical efficacy. If the Company advances a product containing the compound into full development, the Company may be obligated to make payments for development and commercial milestones and pay a royalty on worldwide net sales. The license agreement was accounted for as an asset acquisition and the upfront cash payment of $ 0.5 million was expensed to research and development during the year ended December 31, 2020 as there is no future alternative use for the assets. The following table summarizes costs recognized, in research and development, under the Company’s license agreements and other non-cancellable royalty and milestone obligations (in thousands): Years Ended December 31, 2021 2020 2019 License and other fees $ — $ 500 $ — Milestone fees — 250 100 Total license and related fees $ — $ 750 $ 100 Other Royalty Arrangements In October 2014, the Company entered into an exclusive license agreement with Ipsen that enables the Company to use clinical and nonclinical gacyclidine data generated by Ipsen to support worldwide development and regulatory filings for OTO-313. Under this license agreement, the Company is obligated to pay Ipsen low single-digit royalties on annual net sales of OTO-313 by the Company or its affiliates or sublicensees , up to a maximum cumulative royalty totaling $ 10.0 million. Litigation From time to time, the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course of business. Management believes there are no claims or actions pending against the Company as of December 31, 2021 which will have, individually or in the aggregate, a material adverse effect on its business, liquidity, financial position, or results of operations. Litigation, however, is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm the Company’s business. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Long-term Debt, Unclassified [Abstract] | |
Debt | 6. Debt Term Loans On December 31, 2018 (the Closing Date), the Company entered into a Loan and Security Agreement (the Loan Agreement), among the Company, Oxford Finance LLC, as collateral agent, and the lenders party thereto from time to time. On June 2, 2021 (the New Closing Date), the Company entered into the Third Amendment to the Loan Agreement (the Third Amendment and together with the Loan Agreement, the Loan Agreements), which amends the Loan Agreement. The Third Amendment was accounted for as a modification. The Loan Agreement provides for a $ 15.0 million secured term loan credit facility (the Original Term Loan) and the Third Amendment provides for an additional $ 1.0 million term loan (the New Term Loan and together with the Original Term Loan, the Term Loans). The proceeds of the Term Loans may be used for working capital and general corporate purposes. The Company had the right to prepay the Original Term Loan in whole or in part at any time, subject to a prepayment fee of 1.00 %. Under the Third Amendment, the Company has the right to prepay the Term Loans in whole or in part at any time, subject to a prepayment fee of 3.00 % if prepaid on or prior to the first anniversary of the New Closing Date, 2.00 % if prepaid after the first anniversary of the New Closing Date and on or prior to the second anniversary of the New Closing Date, and 1.00 % thereafter. Amounts prepaid or repaid under the Term Loans may not be reborrowed. The Original Term Loan was fully funded on the Closing Date and the New Term Loan was fully funded on the New Closing Date. The Original Term Loan’s maturity was extended under the Third Amendment from December 1, 2023 to April 1, 2026 (the Maturity Date), and the New Term Loan matures on the Maturity Date. The Company paid a facility fee of 0.75 % of the Original Term Loan and customary closing fees on the Closing Date and customary closing fees in respect of the Third Amendment on the New Closing Date. The Term Loans bear interest at a floating rate equal to the greater of 5.25 % and the prime rate as reported in the Wall Street Journal from time to time, plus 3.75 % ( 9.0 % as of December 31, 2021, the minimum interest rate). Interest on the Term Loans is payable monthly in arrears. The Company was permitted to make interest-only payments on the Original Term Loan until February 1, 2022 , followed by consecutive equal monthly payments of principal and interest in arrears through maturity on December 1, 2023 . Under the Third Amendment, the Company is permitted to make interest-only payments on the Term Loans until June 1, 2023 , followed by consecutive equal monthly payments of principal and interest in arrears through the Maturity Date. The Third Amendment also permits the interest-only period to be extended by an additional twelve months subject to the achievement of certain milestones. The outstanding principal amount of the Term Loans, together with accrued and unpaid interest, is due on the Maturity Date. Upon repayment or acceleration of the Term Loans, a final payment fee equal to 4.00 % of the aggregate original principal amount of the Term Loans is payable (the Final Payment Fee). The Final Payment Fee of $ 0.6 million, as well as the initial facility fee and all other direct fees and costs associated with the Loan Agreements, was recognized as a debt discount. The debt discount is being amortized to interest expense over the term of the Loan Agreements using the effective interest method. The Company’s obligations under the Loan Agreements are secured by substantially all its assets, excluding intellectual property and subject to certain other exceptions and limitations. The Loan Agreements contain customary affirmative covenants, including covenants regarding compliance with applicable laws and regulations, reporting requirements, payment of taxes and other obligations, and maintenance of insurance. Further, subject to certain exceptions, the Loan Agreements contain customary negative covenants limiting the ability of the Company to, among other things, sell assets, allow a change of control to occur (if the Term Loans are not repaid), make acquisitions, incur debt, grant liens, make investments, pay dividends or repurchase stock. The Company has maintained compliance with all such covenants to date. Upon the occurrence and during the continuance of an event of default, the lenders may declare all outstanding principal and accrued and unpaid interest under the Loan Agreements immediately due and payable, increase the applicable rate of interest by 5.00 %, and exercise the other rights and remedies provided for under the Loan Agreements and related loan documents. The events of default under the Loan Agreements include payment defaults, breaches of covenants or representations and warranties, material adverse changes, certain bankruptcy events, cross defaults with certain other indebtedness, and judgment defaults. Interest expense, including amortization of the debt discount, related to the Loan Agreements totaled $ 1.6 million for the year ended December 31, 2021. Accrued interest, included in accounts payable, was $ 0.1 million as of December 31, 2021. The outstanding Term Loan balance was $ 16.0 million as of December 31, 2021, inclusive of accretion of the final payment and net unamortized debt discount. The estimated aggregate amounts and timing of payments on the Company’s long-term debt obligations as of December 31, 2021 for the next five fiscal years are as follows: 2022 $ — 2023 3,657 2024 5,486 2025 5,486 2026 2,011 Subtotal 16,640 Unamortized discount ( 643 ) Total long-term debt, net $ 15,997 PPP Loan On April 10, 2020 the Company obtained an unsecured $ 1.1 million loan through JPMorgan Chase Bank, N.A. under the Paycheck Protection Program (the PPP Loan) pursuant to the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). The PPP Loan bore an interest rate of 0.98 % and notionally matured two years from the date of issuance. Following the issuance of new, retroactive guidance on the program from the Small Business Administration on April 23, 2020 , the Company repaid the PPP Loan principal and accrued interest in full. Interest expense related to the PPP Loan was de minimis for the year ended December 31, 2020. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 7. Leases Operating Leases The Company has existing operating leases for certain office equipment and its facility with initial terms ranging from 36 months to 130 months. The facility lease has an option for the Company to extend the lease term for an additional five years ; however, it is not reasonably certain the Company will exercise the option to renew when the lease term ends in 2027 , and thus, the incremental term was excluded from the calculation of the lease liability and ROU asset. The Company has the right to terminate the lease at the end of the 94th month of the lease term if it is acquired by a third party and pays an early termination fee. In July 2021, the Company entered into a lease for certain equipment with an initial term of 36 months, which includes a purchase option at the end of the lease term based upon the then fair market value of the equipment. The lease payment includes customary principal and interest as well as costs related to the installation and setup of the equipment. The Company evaluated the lease in accordance with ASC 842 and recorded this lease as an operating lease in the balance sheets. The ROU assets associated with all the Company’s operating leases are recognized in the balance sheets. Finance Leases In November 2021, the Company entered into a lease for certain computer equipment with an initial term of 48 months, which includes an option to purchase the equipment at the end of the lease term that is not reasonably certain to be exercised. The lease payment includes customary principal and interest as well as costs related to the installation and setup of the equipment. The associated ROU asset is recognized within property and equipment, net in the balance sheets and is being amortized over four years in accordance with the Company’s standard depreciation and amortization policies. Years Ended December 31, Lease expenses: 2021 2020 Operating lease expenses $ 3,162 $ 3,137 Variable lease expenses 934 793 Total lease expenses $ 4,096 $ 3,930 Lease Maturities: Operating Leases Finance Leases Total 2022 $ 3,365 $ 91 $ 3,456 2023 3,464 91 3,555 2024 3,554 91 3,645 2025 3,642 83 3,725 2026 3,751 — 3,751 Thereafter 2,891 — 2,891 Total minimum lease payments 20,667 356 21,023 Imputed interest ( 5,111 ) ( 57 ) ( 5,168 ) Total 15,556 299 15,855 Less: leases, current ( 3,364 ) ( 91 ) ( 3,455 ) Leases, net of current $ 12,192 $ 208 $ 12,400 |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 8. Fair Value The accounting guidance defines fair value, establishes a consistency framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring basis or nonrecurring basis. 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 on the measurement date. Accounting guidance establishes a three-tier fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. These tiers are based on the source of the inputs and are as follows: Level 1: Observable inputs such as quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. As of December 31, 2021 and 2020, the Company held no assets or liabilities measured at fair value on a nonrecurring basis and no liabilities measured at fair value on a recurring basis. The following fair value hierarchy table presents the Company’s assets measured at fair value on a recurring basis (in thousands): Fair Value Measurement at Reporting Date Using Total Level 1 Level 2 Level 3 December 31, 2021: Assets Money market funds $ 71,493 $ 71,493 $ — $ — $ 71,493 $ 71,493 $ — $ — December 31, 2020: Assets Money market funds $ 23,278 $ 23,278 $ — $ — U.S. Treasury securities 55,086 55,086 — — Certificates of deposit 490 — 490 — $ 78,854 $ 78,364 $ 490 $ — |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity Common Stock Reserved for Future Issuance Shares of common stock reserved for future issuance are as follows: December 31, 2021 2020 Common stock options issued and outstanding 11,707,568 9,842,744 Pre-funded warrants to purchase common stock 11,111,110 4,000,000 Common stock reserved and available for future grant under the 2014 Equity Incentive Plan 1,500,062 2,553,854 Common stock reserved for issuance under ESPP 2,914,710 2,301,704 Unvested restricted stock units 1,650,250 — Total common stock reserved for future issuance 28,883,700 18,698,302 July 2020 Sale of Common Stock and Pre-funded Warrants In July 2020, the Company sold 17,275,000 shares of its common stock at a public offering price of $ 3.25 per share and sold pre-funded warrants to purchase 4,000,000 shares of its common stock at a public offering price of $ 3.249 per pre-funded warrant. After deducting underwriting discounts and commissions and offering expenses, the Company received net proceeds from the offering of $ 64.2 million. The public offering price for the pre-funded warrants was equal to the public offering price of the common stock, less the $ 0.001 per share exercise price of each pre-funded warrant. Per their terms, the outstanding pre-funded warrants to purchase shares of common stock may not be exercised if certain holders’ ownership of the Company’s common stock would exceed 4.99 % following such exercise. The pre-funded warrants are exercisable immediately and do not contain an expiration date. The pre-funded warrants include a cashless exercise provision in the event registered shares are not available, and do not include any mandatory redemption provisions. The pre-funded warrants are recorded as a component of stockholders’ equity within additional paid-in capital. The pre-funded warrants are included in the computation of basic net loss per share as the exercise price is nominal and may be exercised at any time until the pre-funded warrants are exercised in full. During the year ended December 31, 2021, none of the July 2020 pre-funded warrants were exercised; as of December 31, 2021, all of the July 2020 pre-funded warrants remained issued and outstanding. April 2021 Sale of Common Stock and Pre-funded Warrants In April 2021, the Company sold 8,298,890 shares of its common stock at a public offering price of $ 2.25 per share and sold pre-funded warrants to purchase 7,111,110 shares of its common stock at a public offering price of $ 2.249 per pre-funded warrant. After deducting underwriting discounts and commissions and offering expenses, the Company received net proceeds from the offering of $ 32.2 million. The public offering price for the pre-funded warrants was equal to the public offering price of the common stock, less the $ 0.001 per share exercise price of each pre-funded warrant. Per their terms, the outstanding pre-funded warrants to purchase shares of common stock may not be exercised if certain holders’ ownership of the Company’s common stock would exceed a specified threshold following such exercise. The pre-funded warrants are exercisable immediately and do not contain an expiration date. The pre-funded warrants include a cashless exercise provision in the event registered shares are not available, and do not include any mandatory redemption provisions. The pre-funded warrants are recorded as a component of stockholders’ equity within additional paid-in capital. The pre-funded warrants are included in the computation of basic net loss per share as the exercise price is nominal and may be exercised at any time until the pre-funded warrants are exercised in full. During the year ended December 31, 2021, none of the April 2021 pre-funded warrants were exercised; as of December 31, 2021, all of the April 2021 pre-funded warrants remained issued and outstanding. |
Stock-Based Compensation and Eq
Stock-Based Compensation and Equity Plans | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation and Equity Plans | 10. Stock-Based Compensation and Equity Plans 2014 Equity Incentive Plan The Company granted awards under its 2010 Equity Incentive Plan (the 2010 Plan) until June 2014. In July 2014, the Company’s board of directors adopted and the Company’s stockholders approved its 2014 Equity Incentive Plan (the 2014 Plan), which became effective in August 2014. In connection with the adoption of the 2014 Plan, the Company terminated the 2010 Plan for future use and provided that no further equity awards were to be granted under the 2010 Plan. All outstanding awards under the 2010 Plan continue to be governed by their existing terms. The 2014 Plan permits the grant of incentive stock options to the Company’s employees and the grant of nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to the Company’s employees, directors and consultants. The Company accounts for stock-based compensation expense related to stock options by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model, while market price of the Company’s common stock at the date of grant is used for restricted stock unit awards. Options granted under the 2014 Plan are generally scheduled to vest over four years , subject to continued service, and subject to certain acceleration of vesting provisions, expire no later than 10 years from the date of grant. Options granted under the 2014 Plan must have a per share exercise price equal to at least 100 % of the fair market value of a share of the common stock as of the date of grant. Restricted stock units granted under the 2014 Plan are generally scheduled to vest over two to three years . Under the evergreen provision of the 2014 Plan, the number of shares available for issuance under the 2014 Plan includes an annual increase on the first day of each fiscal year equal to the lesser of (i) 2,500,000 shares; (ii) 5 % of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. Effective January 1, 2022, the number of shares available for future issuance was increased by 2,500,000 shares so that the total available for future issuance as of January 1, 2022 was 4,000,062 shares. As of December 31, 2021, 1,500,062 shares of common stock were available for future grant under the 2014 Plan. The following table summarizes stock option activity for the year ended December 31, 2021 (in thousands except per share amounts and years): Options Weighted- Weighted- Aggregate Outstanding as of December 31, 2020 9,843 $ 4.11 Granted 2,965 $ 4.26 Exercised ( 3 ) $ 2.11 Forfeited ( 1,097 ) $ 4.10 Outstanding as of December 31, 2021 11,708 $ 4.15 6.8 $ 460 Options vested and expected to vest as of 11,708 $ 4.15 6.8 $ 460 Options exercisable as of December 31, 2021 6,994 $ 4.44 5.6 $ 348 The following table summarizes certain information regarding stock options (in thousands, except per share data): Years Ended December 31, 2021 2020 2019 Weighted-average grant-date fair value per share of $ 3.32 $ 2.68 $ 1.64 Cash received from options exercised during the 6 206 5 Intrinsic value of options exercised during the period 1 59 2 The following table summarizes restricted stock unit activity for the year ended December 31, 2021 (share amounts in thousands): Restricted Stock Units Weighted-Average Grant-Date Unvested as of December 31, 2020 — $ — Granted 1,697 $ 2.16 Vested — $ — Forfeited ( 47 ) $ 2.16 Unvested as of December 31, 2021 1,650 $ 2.16 2014 Employee Stock Purchase Plan In July 2014, the Company’s board of directors adopted and the stockholders approved the Company’s 2014 Employee Stock Purchase Plan (the ESPP), which became effective upon adoption by the Company’s board of directors. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15 % of their eligible compensation, subject to any plan limitations. The offering periods generally start on the first trading day on or after June 1 and December 1 of each year and end on the first trading day on or before June 1 and December 1 approximately twenty-four months later, and include six-month purchase periods. The Company accounts for stock-based compensation expense related to ESPP rights by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model. The number of shares available for issuance under the ESPP includes an annual increase on the first day of each fiscal year, equal to the lesser of (i) 800,000 shares; (ii) 1.5 % of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. Effective January 1, 2022, the number of shares available for future issuance was increased by 800,000 shares so that the total available for future issuance as of January 1, 2022 was 3,714,710 shares. As of December 31, 2021, the Company had issued 707,333 shares of common stock under the ESPP and had 2,914,710 shares available for future issuance. Stock-Based Compensation Expense The following are the weighted-average underlying assumptions used to determine the fair value of stock options and ESPP rights using the Black-Scholes-Merton option pricing model: Years Ended December 31, 2021 2020 2019 Stock Options: Risk-free interest rate 0.8 % 1.5 % 2.5 % Expected dividend yield 0.0 % 0.0 % 0.0 % Expected volatility 99.2 % 96.7 % 98.1 % Expected term (in years) 6.0 6.1 6.1 Employee Stock Purchase Plan: Risk-free interest rate 0.1 % 0.1 % 2.0 % Expected dividend yield 0.0 % 0.0 % 0.0 % Expected volatility 90.9 % 69.8 % 69.5 % Expected term (in years) 1.3 1.3 1.3 Risk-Free Interest Rate. The Company bases the risk-free interest rate assumption on observed interest rates appropriate for the expected term of the option grants. Expected Dividend Yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends. Expected Volatility. The expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biopharmaceutical industry. Expected Term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determines the expected life assumption using the simplified method, which is an average of the contractual term of the option and its ordinary vesting period. Total non-cash stock-based compensation expense recognized in the statements of operations is as follows (in thousands): Years Ended December 31, 2021 2020 2019 Cost of product sales $ 3 $ 13 $ 12 Research and development 3,355 2,456 2,085 Selling, general and administrative 4,039 3,642 2,793 Total stock-based compensation $ 7,397 $ 6,111 $ 4,890 As of December 31, 2021 , unrecognized compensation cost related to stock options was $ 11.1 million which is expected to be recognized over a remaining weighted-average vesting period of 2.5 years. As of December 31, 2021 , unrecognized compensation cost related to restricted stock units was $ 2.8 million which is expected to be recognized over a remaining weighted-average vesting period of 2.2 years. As of December 31, 2021 , unrecognized compensation cost related to ESPP rights was $ 0.2 million which is expected to be recognized over a remaining weighted-average vesting period of 1.3 years. |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Collaborative Arrangement Disclosure [Abstract] | |
Collaboration Agreements | 11. Collaboration Agreements AGTC collaboration In October 2019, the Company announced a strategic collaboration with AGTC to co-develop and co-commercialize an adeno-associated virus (AAV)-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the GJB2 gene. Under the collaboration agreement, the Company and AGTC equally shared the program costs and any revenue or other proceeds related to the program through December 31, 2021. Effective January 1, 2022, the collaboration agreement was amended to increase the Company’s responsibility for the overall development and commercialization of the program, which resulted in: (i) an increase in the Company’s share of future product development costs and (ii) the Company’s obligation to make potential future payments including royalties on any product sales in lieu of equal sharing of any profits or proceeds related to the program. Co-Promotion Agreement The Company entered into a co-promotion agreement with ALK-Abelló, Inc. (ALK) in June 2020, (the Co-Promotion Agreement) to support the promotion of OTIPRIO for the treatment of AOE in physician offices. During the term of the Co-Promotion Agreement, ALK reimbursed the Company for certain expenses, including a proportion of product support expenses; such payments were accounted for as reductions to selling, general and administrative expense. ALK was entitled to a share of gross profits totaling more than 50 % from the sale of OTIPRIO to its accounts. The Company’s payments to ALK for its portion of the gross profit were recognized as selling, general and administrative expense. The Company was the principal in the product sale of OTIPRIO and recognized all revenue and related cost of product sales. For the years ended December 31, 2021 and 2020, the Company recognized reductions in selling, general and administrative expenses related to the Co-Promotion Agreement of $ 0.5 million and $ 0.3 million, respectively. In May 2021, the Company sold the assets related to its OTIPRIO business to ALK. |
Disposition of a Business
Disposition of a Business | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Disposition of a Business | 12. Disposition of a Business On May 28, 2021, the Company sold the assets related to OTIPRIO to ALK for an upfront payment of $ 0.8 million and additional potential amounts based on net sales of OTIPRIO for a specified period of time. The transaction was treated as a sale of a business. The contingent value of the remaining sale price will be measured and recognized in accordance with the gain contingency guidance which results in recognition when the gain is realized or realizable. The Company determined that the disposition of the business did not constitute a strategic shift and that it did not and will not have a major effect on its operations and financial results. Accordingly, the operations associated with the disposition are not reported in discontinued operations. The gain on sale of approximately $ 23,000 after accounting for liabilities transferred upon sale and the carrying amount of assets sold is recorded to selling, general and administrative expenses |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, annual use of the Company’s net operating loss carryforwards may be subject to substantial annual limitations in the event a cumulative change in ownership of more than 50% occurs within a three-year period. If ownership changes within the meaning of IRC Section 382 are identified as having occurred, the amount of remaining tax attribute carryforwards available to offset future taxable income and income tax expense in future years may be significantly restricted or eliminated. Further, the Company’s deferred tax assets associated with such tax attributes could be significantly reduced upon realization of an ownership change within the meaning of IRC Section 382. The Company completed an ownership change analysis pursuant to IRC Section 382 through December 31, 2020 and reduced deferred tax assets related to net operating loss carryforwards and research and development tax credit carryforwards accordingly. The Company is in the process of completing an analysis through December 31, 2021 which could result in substantial limitations. When the analysis is completed, the Company will adjust deferred tax assets, if any, accordingly. Due to the existence of the full valuation allowance against the Company’s net deferred tax assets, limitations created by ownership changes, if any, will not impact the Company’s effective tax rate. Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 99,450 $ 88,013 Research and development credits 11,107 9,985 Depreciation and amortization 7,940 10,212 Accrued expenses 694 850 Lease liabilities 3,373 3,816 Stock compensation 4,083 3,856 Other, net 94 234 Total deferred tax assets 126,741 116,966 Less: valuation allowance ( 124,040 ) ( 113,826 ) Total deferred tax assets, net of valuation allowance 2,701 3,140 Deferred tax liability: Right-of-use assets ( 2,701 ) ( 3,140 ) Total deferred tax liability ( 2,701 ) ( 3,140 ) Total $ — $ — Due to the Company’s history of losses and uncertainty regarding future earnings, a full valuation allowance has been recorded against the Company’s net deferred tax assets, as it is more likely than not that such net assets will not be realized. A valuation allowance of approximately $ 124.0 million and $ 113.8 million has been established as of December 31, 2021 and 2020, respectively. At December 31, 2021, the Company had federal and state net operating loss carryforwards of approximately $ 436.7 million and $ 127.1 million, respectively. Of the federal net operating loss carryforwards, approximately $ 196.1 million were generated in a taxable year beginning after December 31, 2017, and therefore do not expire. Federal net operating losses that occur after January 1, 2018 are subject to a taxable income limitation of 80 % in accordance with the Tax Cuts and Jobs Act of 2017 (the Tax Act). The remaining federal and state net operating loss carryforwards will begin to expire in 2030 , unless previously utilized. As of December 31, 2021, the Company also had federal and California research and development credit carryforwards of approximately $ 13.4 million and $ 6.5 million, respectively. The federal research and development credit carryforwards will begin expiring in 2030 , unless previously utilized. The California research credit will carry forward indefinitely . The following is a reconciliation of the expected recovery of income taxes between those that are based on enacted tax rates and laws, to those currently reported for the years ended December 31 (in thousands): 2021 2020 2019 Federal statutory rate $ ( 10,748 ) $ ( 9,393 ) $ ( 9,382 ) State tax (net of federal benefit) 500 334 299 Permanent items, other 11 9 189 Stock compensation 1,349 1,595 2,470 Other adjustments ( 204 ) 687 523 Research and development credits ( 1,870 ) ( 1,774 ) ( 1,595 ) Uncertain tax positions 748 710 638 Change in valuation allowance 10,214 7,832 6,858 Provision for income taxes $ 0 $ 0 $ 0 The following table summarizes the activity related to the Company’s gross unrecognized tax benefits (in thousands): December 31, 2021 2020 2019 Balance at the beginning of the year $ 11,514 $ 10,739 $ 10,052 Adjustments related to prior year tax positions ( 83 ) ( 21 ) ( 80 ) Increases related to current year tax positions 885 796 767 $ 12,316 $ 11,514 $ 10,739 The Company’s policy is to include interest and penalties related to unrecognized income tax benefits as a component of income tax expense. The Company has no accruals for interest or penalties in the balance sheets as of December 31, 2021 and 2020 and has no t recognized interest or penalties in the statements of operations for the years ended December 31, 2021, 2020 and 2019. Due to the valuation allowance recorded against the Company’s net deferred tax assets, future changes in unrecognized tax benefits will not impact the Company’s effective tax rate. The Company does not expect its unrecognized tax benefits to change significantly in the next 12 months. The Company is subject to taxation in the United States for federal and state purposes. Due to the net operating loss carryforwards, the U.S. federal and state returns are open to examination by the IRS and state tax authorities for all years since inception. The Company is not currently under examination by the federal or any state tax authority. |
Description of Business and B_2
Description of Business and Basis of Presentation (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company follows Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements—Going Concern , which requires that management perform a two-step analysis over its ability to continue as a going concern. Management must first evaluate whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern and to meet its obligations as they become due within one year after the date that the financial statements are issued (step 1). If management concludes that substantial doubt is raised, management is also required to consider whether its plans alleviate that doubt (step 2). The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred operating losses and negative cash flows from operating activities since inception. As of December 31, 2021, the Company had cash, cash equivalents and short-term investments of $ 77.4 million, outstanding debt of $ 16.0 million and an accumulated deficit of $ 555.8 million. The Company anticipates that it will continue to incur net losses into the foreseeable future as it: (i) develops and seeks regulatory approvals for its product candidates; and (ii) works to develop additional product candidates through research and development programs. When additional financing is required, the Company anticipates that it will seek additional funding through future debt and/or equity financings or other sources, such as potential collaboration agreements. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. If the Company is not able to secure adequate additional funding, if or when necessary, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects. The Company believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations for a period of at least twelve months from the date of this report. |
Use of Estimates | Use of Estimates The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of product sales and expense during the reporting period. Although these estimates are based on the Company’s knowledge of current events and anticipated actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institution in which those deposits are held. Additionally, the Company established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of cash and highly liquid investments with original maturities of three months or less at the date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments. Cash and cash equivalents include cash in readily available checking, savings and money market accounts. The Company’s restricted cash consists of cash maintained in separate deposit accounts to secure a letter of credit issued by a bank to the landlord under a lease agreement for the Company’s corporate headquarters. |
Short-Term Investments | Short-term Investments From time to time, the Company carries short-term investments classified as available-for-sale debt securities at fair value as determined by prices for identical or similar securities at the balance sheet date. Short-term investments consist of Level 1 financial instruments in the fair value hierarchy (see Note 8 – Fair Value ). Realized gains or losses of available-for-sale securities are determined using the specific identification method and net realized gains and losses are included in interest income. The Company periodically reviews available-for-sale securities for other-than-temporary declines in fair value below the cost basis, and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company records unrealized gains and losses on available-for-sale debt securities as a component of other comprehensive loss within the statements of comprehensive loss and as a separate component of stockholders’ equity on the balance sheets. The Company does not hold equity securities in its investment portfolio. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments include cash, cash equivalents, short-term investments, prepaid expenses and other assets, accounts payable, accrued expenses, accrued compensation and long-term debt. The carrying value of the Company’s cash and cash equivalents, short-term investments, prepaid expenses and other current assets, other long-term assets, accounts payable, accrued expenses, and accrued compensation approximate fair value due to the short-term nature of these items. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, the Company believes the fair value of long-term debt approximates its carrying value. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment generally consist of manufacturing equipment, office furniture and equipment, computers, and scientific equipment and are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally two to ten years ). Leasehold improvements are recorded at cost and are depreciated on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. During the year ended December 31, 2021, the Company recorded an impairment to property and equipment, net of $ 0.7 million. No impairment was recorded during the years ended December 31, 2020 and 2019. Repairs and maintenance costs are charged to expense as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company assesses the value of its long-lived assets for impairment on an annual basis and whenever events indicate that the carrying amount of such assets may not be recoverable. While the Company’s current and historical operating losses and negative cash flows are indicators of impairment, the Company believes that future cash flows to be received support the carrying value of its long-lived assets. No impairment of long-lived assets was recorded during the years ended December 31, 2021, 2020 and 2019. |
Right-of-Use Assets and Lease Liabilities | Right-of-Use Assets and Lease Liabilities The Company has operating leases for its facility and certain equipment and finance leases for certain computer equipment. The Company determines if an arrangement is or contains a lease at each commencement date. Accounting Standards Codification (ASC) 842, Leases (ASC 842) establishes a right-of-use (ROU) model that requires a lessee to recognize an ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Accounting Standards Update (ASU) No. 2016-02, Leases (ASU 2016-02) provides a number of optional practical expedients and accounting policy elections. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. Operating leases are included in ROU assets, Leases, current, and Leases, net of current on the balance sheets. Finance leases are included in Property and equipment, Leases, current, and Leases, net of current on the balance sheets. The Company has elected a policy not to recognize short-term leases (one year or less) on the balance sheets. ROU assets and operating lease liabilities are recognized based on the present value of future minimum lease payments over the lease term at the commencement date. When the implicit rate of the lease is not provided or cannot be determined, the Company uses a collateralized incremental borrowing rate based on the information available at the commencement date, including lease term, in determining the present value of future payments. The Company considers payments for common area maintenance, real estate taxes and management fees to be variable non-lease components, which are expensed as incurred. Lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. |
Clinical Trial Expense Accruals | Clinical Trial Expense Accruals The Company estimates expenses resulting from its obligations under contracts with vendors, contract research organizations (CROs) and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided. The Company records clinical trial expenses in the period in which services are performed and efforts are expended. The Company accrues for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company estimates accruals through financial models taking into account discussion with applicable personnel and outside service providers as to the progress of trials. During the course of a clinical trial, the Company may adjust its clinical accruals if actual results differ from its estimates. |
Collaborative Arrangements | Collaborative Arrangements The Company has entered into co-promotion agreements and research agreements that fall under the scope of ASC Topic 808, Collaborative Arrangements (ASC 808). Co-promotion agreements can include payments and reimbursements for a proportion of product support expenses to the Company and profit sharing payments by the Company. Payments to or by the Company are recognized in selling, general and administrative expenses in the statements of operations. Research agreements can include reimbursements to or by the Company, which are recognized in research and development expenses in the statements of operations. |
License Fees | License Fees The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain, and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates would be reached when the requisite regulatory approvals are obtained to make the product available for sale. |
Research and Development | Research and Development Research and development expenses include the costs associated with the Company’s research and development activities, including salaries, benefits, stock-based compensation expense and occupancy costs. Also included in research and development expenses are third-party costs incurred in conjunction with contract manufacturing for the Company’s research and development programs and clinical trials, including the cost of clinical trial drug supply, costs incurred by CROs and regulatory expenses. Research and development costs are expensed as incurred. |
Selling, General and Administrative | Selling, General and Administrative Selling, general and administrative expenses include the costs associated with the Company’s executive, administrative, finance and human resource functions including salaries, benefits, stock-based compensation expense and occupancy costs. Other selling, general and administrative expenses include costs associated with prosecuting and maintaining the Company’s patent portfolio, corporate legal expenses, costs required for public company activities and infrastructure necessary for the general conduct of the Company’s business. The Company’s selling, general and administrative expenses also include OTIPRIO product support expenses, and profit-sharing fees payable to the Company’s partners, which are reduced by payments received from the Company’s partners under its co-promotion agreements. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation expense related to stock options and employee stock purchase plan (ESPP) rights by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model, while market price of the Company’s common stock at the date of grant is used for restricted stock unit awards. Forfeitures are recognized as incurred. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized using the straight-line method. For performance-based awards to employees, (i) the fair value of the award is determined on the grant date, (ii) the Company assesses the probability of the individual performance milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. |
Income Taxes | Income Taxes The accounting guidance for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities based on the technical merits of the position. The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. |
Net Loss Per Share | Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. As of December 31, 2021, potentially dilutive securities excluded from the calculation of diluted net loss per share consist of outstanding options to purchase 11,707,568 shares of the Company’s common stock and 1,650,250 unvested restricted stock units. As of December 31, 2020 and 2019, potentially dilutive securities excluded from the calculation of diluted net loss per share consist of outstanding options to purchase 9,842,744 and 7,495,129 shares of the Company’s common stock, respectively. |
Risks and Uncertainties Related to COVID-19 | Risks and Uncertainties Related to COVID-19 In March 2020, the World Health Organization declared COVID-19 a global pandemic. The COVID-19 pandemic could pose significant risks to the Company’s business; however, the ultimate impact of the pandemic is highly uncertain. Given the unprecedented and evolving nature of the COVID-19 pandemic, including the rise of new variants, there continues to be significant uncertainty about the progression and ultimate impact of the pandemic on the Company’s operations. The Company has taken steps to mitigate the impact of the COVID-19 pandemic on its clinical trials, including developing processes to ensure the integrity of data collection from enrolled patients and supporting sites’ ability to enroll patients, among other activities. Nonetheless the Company does not know the full extent of potential future delays or impacts on its business operations, its preclinical programs and clinical trials, healthcare systems, its financial condition, or the global economy as a whole resulting from the COVID-19 pandemic. In addition, as a result of the COVID-19 pandemic, the Company has taken steps to protect the health and safety of its employees and community by following directives from the State of California and the applicable local governments, and guidance from the U.S. Centers for Disease Control and Prevention (CDC). Various safety protocols have been implemented and the Company is currently allowing employees who can remotely perform their essential functions to work from home. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Not Yet Adopted In June 2016, ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13) was issued, as amended. ASU 2016-13 introduces the current expected credit loss model, which will require an entity to measure credit losses for certain financial instruments and financial assets. ASU 2016-13 will also apply to receivables arising from revenue transactions such as accounts receivable. ASU 2016-13 is effective for the Company beginning January 1, 2023. The Company does not expect the adoption of ASU 2016-13 to have a material effect on its financial position, results of operations or cash flows. Recently Adopted Effective January 1, 2021, the Company early adopted ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (ASU 2020-06). ASU 2020-06 simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. There was no cumulative effect to be recognized in connection with the early adoption of ASU 2020-06 and the adoption did not have a material impact on the Company’s financial statements or disclosure s. |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Debt Securities | Available-for-sale debt securities with maturities of more than three months from the date of purchase as of December 31, 2020 have been classified as short-term investments, and were as follows (in thousands): Amortized Unrealized Unrealized Market Value December 31, 2020: U.S. Treasury securities $ 55,085 $ 2 $ ( 1 ) $ 55,086 Certificates of deposit 490 — — 490 $ 55,575 $ 2 $ ( 1 ) $ 55,576 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Property and Equipment, Net | Property and equipment, net consists of the following (in thousands): December 31, 2021 2020 Laboratory equipment $ 4,252 $ 4,265 Manufacturing equipment 82 1,075 Computer equipment and software 1,488 989 Leasehold improvements 822 768 Office furniture 1,507 1,548 8,151 8,645 Less: accumulated depreciation ( 6,380 ) ( 5,879 ) Total $ 1,771 $ 2,766 |
Accrued Expenses | Accrued expenses consist of the following (in thousands): December 31, 2021 2020 Accrued clinical trial costs $ 1,279 $ 1,477 Accrued other 3,059 1,476 Total $ 4,338 $ 2,953 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Additional Milestone Payments under Intellectual Property License Agreements | The Company may be obligated to make additional milestone payments under the Company’s intellectual property license agreements covering OTO-313 and OTO-413 as follows (in thousands): Development $ 1,250 Regulatory 7,675 Commercialization 1,000 Total $ 9,925 |
Summary of Costs Recognized under License Agreements and Other Non-Cancellable Royalty and Milestone Obligations | The following table summarizes costs recognized, in research and development, under the Company’s license agreements and other non-cancellable royalty and milestone obligations (in thousands): Years Ended December 31, 2021 2020 2019 License and other fees $ — $ 500 $ — Milestone fees — 250 100 Total license and related fees $ — $ 750 $ 100 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Long-term Debt, Unclassified [Abstract] | |
Summary of Estimated Aggregate Amounts and Timing of Payments on Long-term Debt Obligations | The estimated aggregate amounts and timing of payments on the Company’s long-term debt obligations as of December 31, 2021 for the next five fiscal years are as follows: 2022 $ — 2023 3,657 2024 5,486 2025 5,486 2026 2,011 Subtotal 16,640 Unamortized discount ( 643 ) Total long-term debt, net $ 15,997 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Summary of Lease Expenses | Years Ended December 31, Lease expenses: 2021 2020 Operating lease expenses $ 3,162 $ 3,137 Variable lease expenses 934 793 Total lease expenses $ 4,096 $ 3,930 |
Future Minimum Annual Obligations under Finance and Operating Lease Commitments | Lease Maturities: Operating Leases Finance Leases Total 2022 $ 3,365 $ 91 $ 3,456 2023 3,464 91 3,555 2024 3,554 91 3,645 2025 3,642 83 3,725 2026 3,751 — 3,751 Thereafter 2,891 — 2,891 Total minimum lease payments 20,667 356 21,023 Imputed interest ( 5,111 ) ( 57 ) ( 5,168 ) Total 15,556 299 15,855 Less: leases, current ( 3,364 ) ( 91 ) ( 3,455 ) Leases, net of current $ 12,192 $ 208 $ 12,400 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Assets Measured on a Recurring Basis | The following fair value hierarchy table presents the Company’s assets measured at fair value on a recurring basis (in thousands): Fair Value Measurement at Reporting Date Using Total Level 1 Level 2 Level 3 December 31, 2021: Assets Money market funds $ 71,493 $ 71,493 $ — $ — $ 71,493 $ 71,493 $ — $ — December 31, 2020: Assets Money market funds $ 23,278 $ 23,278 $ — $ — U.S. Treasury securities 55,086 55,086 — — Certificates of deposit 490 — 490 — $ 78,854 $ 78,364 $ 490 $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Shares of Common Stock Reserved for Future Issuance | Shares of common stock reserved for future issuance are as follows: December 31, 2021 2020 Common stock options issued and outstanding 11,707,568 9,842,744 Pre-funded warrants to purchase common stock 11,111,110 4,000,000 Common stock reserved and available for future grant under the 2014 Equity Incentive Plan 1,500,062 2,553,854 Common stock reserved for issuance under ESPP 2,914,710 2,301,704 Unvested restricted stock units 1,650,250 — Total common stock reserved for future issuance 28,883,700 18,698,302 |
Stock-Based Compensation and _2
Stock-Based Compensation and Equity Plans (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity for the year ended December 31, 2021 (in thousands except per share amounts and years): Options Weighted- Weighted- Aggregate Outstanding as of December 31, 2020 9,843 $ 4.11 Granted 2,965 $ 4.26 Exercised ( 3 ) $ 2.11 Forfeited ( 1,097 ) $ 4.10 Outstanding as of December 31, 2021 11,708 $ 4.15 6.8 $ 460 Options vested and expected to vest as of 11,708 $ 4.15 6.8 $ 460 Options exercisable as of December 31, 2021 6,994 $ 4.44 5.6 $ 348 |
Summary of Certain Information Regarding Stock Options | The following table summarizes certain information regarding stock options (in thousands, except per share data): Years Ended December 31, 2021 2020 2019 Weighted-average grant-date fair value per share of $ 3.32 $ 2.68 $ 1.64 Cash received from options exercised during the 6 206 5 Intrinsic value of options exercised during the period 1 59 2 |
Summary of Restricted Stock Unit, Activity | The following table summarizes restricted stock unit activity for the year ended December 31, 2021 (share amounts in thousands): Restricted Stock Units Weighted-Average Grant-Date Unvested as of December 31, 2020 — $ — Granted 1,697 $ 2.16 Vested — $ — Forfeited ( 47 ) $ 2.16 Unvested as of December 31, 2021 1,650 $ 2.16 |
Weighted-Average Underlying Assumptions Used to Determine Fair Value of Stock Options and ESPP Rights | The following are the weighted-average underlying assumptions used to determine the fair value of stock options and ESPP rights using the Black-Scholes-Merton option pricing model: Years Ended December 31, 2021 2020 2019 Stock Options: Risk-free interest rate 0.8 % 1.5 % 2.5 % Expected dividend yield 0.0 % 0.0 % 0.0 % Expected volatility 99.2 % 96.7 % 98.1 % Expected term (in years) 6.0 6.1 6.1 Employee Stock Purchase Plan: Risk-free interest rate 0.1 % 0.1 % 2.0 % Expected dividend yield 0.0 % 0.0 % 0.0 % Expected volatility 90.9 % 69.8 % 69.5 % Expected term (in years) 1.3 1.3 1.3 |
Summary of Non-cash Stock Based Compensation Expense | Total non-cash stock-based compensation expense recognized in the statements of operations is as follows (in thousands): Years Ended December 31, 2021 2020 2019 Cost of product sales $ 3 $ 13 $ 12 Research and development 3,355 2,456 2,085 Selling, general and administrative 4,039 3,642 2,793 Total stock-based compensation $ 7,397 $ 6,111 $ 4,890 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 99,450 $ 88,013 Research and development credits 11,107 9,985 Depreciation and amortization 7,940 10,212 Accrued expenses 694 850 Lease liabilities 3,373 3,816 Stock compensation 4,083 3,856 Other, net 94 234 Total deferred tax assets 126,741 116,966 Less: valuation allowance ( 124,040 ) ( 113,826 ) Total deferred tax assets, net of valuation allowance 2,701 3,140 Deferred tax liability: Right-of-use assets ( 2,701 ) ( 3,140 ) Total deferred tax liability ( 2,701 ) ( 3,140 ) Total $ — $ — |
Reconciliation of Expected Recovery of Income Taxes | The following is a reconciliation of the expected recovery of income taxes between those that are based on enacted tax rates and laws, to those currently reported for the years ended December 31 (in thousands): 2021 2020 2019 Federal statutory rate $ ( 10,748 ) $ ( 9,393 ) $ ( 9,382 ) State tax (net of federal benefit) 500 334 299 Permanent items, other 11 9 189 Stock compensation 1,349 1,595 2,470 Other adjustments ( 204 ) 687 523 Research and development credits ( 1,870 ) ( 1,774 ) ( 1,595 ) Uncertain tax positions 748 710 638 Change in valuation allowance 10,214 7,832 6,858 Provision for income taxes $ 0 $ 0 $ 0 |
Unrecognized Tax Benefit | The following table summarizes the activity related to the Company’s gross unrecognized tax benefits (in thousands): December 31, 2021 2020 2019 Balance at the beginning of the year $ 11,514 $ 10,739 $ 10,052 Adjustments related to prior year tax positions ( 83 ) ( 21 ) ( 80 ) Increases related to current year tax positions 885 796 767 $ 12,316 $ 11,514 $ 10,739 |
Description of Business and B_3
Description of Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2021 | Jul. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Description Of Business And Basis Of Presentation [Line Items] | ||||
Cash, cash equivalents and short-term investments | $ 77,400 | |||
Accumulated deficit | (555,805) | $ (504,624) | ||
Common stock sold in public offering | 8,298,890 | 17,275,000 | ||
Debt outstanding | $ 16,000 | |||
Net proceeds after deducting underwriters commission | $ 32,200 | $ 64,200 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2021USD ($)Segmentshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Property and equipment useful lives | 2 years | ||
Impairment of property and equipment | $ | $ 700,000 | $ 0 | $ 0 |
Impairment of long-lived assets | $ | $ 727,000 | $ 0 | $ 0 |
Potentially dilutive securities excluded from the calculation of diluted net loss per share | 11,707,568 | ||
Unvested Restricted Stock Unit [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Potentially dilutive securities excluded from the calculation of diluted net loss per share | 1,650,250 | ||
Options to Purchase Common Stock [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Potentially dilutive securities excluded from the calculation of diluted net loss per share | 9,842,744 | 7,495,129 | |
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment useful lives | 2 years | ||
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment useful lives | 10 years |
Available-for-Sale Securities -
Available-for-Sale Securities - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2021USD ($)Security | Dec. 31, 2020USD ($) | |
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale debt securities | $ 0 | $ 55,576,000 |
Number of available-for-sale securities in unrealized loss positions for less than twelve months | Security | 0 | |
Other-than-temporary declines in the value of any available-for-sale securities | $ 0 | |
Maximum maturity of available-for-sale debt securities | 1 year | |
Available-for-sale Securities [Member] | Money Market Funds and Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cash equivalents | $ 71,500,000 | $ 23,300,000 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Schedule of Available-for-Sale Debt Securities (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2021 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 55,575 | |
Unrealized Gains | 2 | |
Unrealized Losses | 1 | |
Market Value | 55,576 | $ 0 |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 55,085 | |
Unrealized Gains | 2 | |
Unrealized Losses | 1 | |
Market Value | 55,086 | |
Certificates Of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 490 | |
Unrealized Gains | ||
Unrealized Losses | ||
Market Value | $ 490 |
Balance Sheet Details - Propert
Balance Sheet Details - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 8,151 | $ 8,645 |
Less: accumulated depreciation and amortization | (6,380) | (5,879) |
Total | 1,771 | 2,766 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,252 | 4,265 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 82 | 1,075 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,488 | 989 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 822 | 768 |
Office Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,507 | $ 1,548 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 856 | $ 1,062 | $ 1,149 |
Balance Sheet Details - Accrued
Balance Sheet Details - Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued clinical trial costs | $ 1,279 | $ 1,477 |
Accrued other | 3,059 | 1,476 |
Total | $ 4,338 | $ 2,953 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | May 28, 2021 | Jul. 31, 2020 | Dec. 31, 2016 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | May 31, 2015 |
Other Commitments [Line Items] | |||||||
Construction commencement period | 2016-12 | ||||||
Operating lease term | 130 months | ||||||
Additional operating lease term | 5 years | 5 years | |||||
Monthly base rent for first year | $ 232,000 | ||||||
Lease rate increase, percentage | 3.00% | ||||||
Abatement period of monthly base rent | 10 months | ||||||
Estimated base rent payments over the life of lease | $ 32,700,000 | ||||||
Milestone fees | $ 0 | $ 250,000 | $ 100,000 | ||||
Research and development | 34,673,000 | $ 27,997,000 | $ 32,805,000 | ||||
License Agreement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Additional payments due upon demonstration | $ 500,000 | ||||||
Upfront Payment [Member] | |||||||
Other Commitments [Line Items] | |||||||
Payment to acquire worldwide rights | $ 800,000 | ||||||
Upfront Payment [Member] | License Agreement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Payment to acquire worldwide rights | 500,000 | ||||||
Research and development | $ 500,000 | ||||||
Intellectual Property [Member] | License Agreement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Milestones potential cash payment | $ 300,000 | ||||||
Data License Agreement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Description of royalties payable | the Company is obligated to pay Ipsen low single-digit royalties on annual net sales of OTO-313 by the Company or its affiliates or sublicensees | ||||||
Maximum cumulative royalties paid under license agreement | $ 10,000,000 | ||||||
Restricted Cash [Member] | |||||||
Other Commitments [Line Items] | |||||||
Security deposit in the form of letter of credit | $ 700,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Additional Milestone Payments under Intellectual Property License Agreements (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Other Commitments [Line Items] | |
Cash Payments | $ 9,925 |
Development [Member] | |
Other Commitments [Line Items] | |
Cash Payments | 1,250 |
Regulatory [Member] | |
Other Commitments [Line Items] | |
Cash Payments | 7,675 |
Commercialization [Member] | |
Other Commitments [Line Items] | |
Cash Payments | $ 1,000 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Costs Recognized under License Agreements and Other Non-Cancellable Royalty and Milestone Obligations (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |||
License and other fees | $ 0 | $ 500 | $ 0 |
Milestone fees | 0 | 250 | 100 |
Total license and related fees | $ 0 | $ 750 | $ 100 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Apr. 10, 2020 | |
Debt Instrument [Line Items] | |||
Debt discount, amount | $ 643 | ||
Term Loan outstanding | $ 15,997 | $ 15,158 | |
Maximum [Member] | |||
Debt Instrument [Line Items] | |||
Term Loan Amended To Extend Interest Only Period Date | Feb. 1, 2022 | ||
Maximum [Member] | Third Amendment [Member] | |||
Debt Instrument [Line Items] | |||
Term Loan Amended To Extend Interest Only Period Date | Jun. 1, 2023 | ||
Secured Term Loan Credit Facility [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, face amount | $ 15,000 | ||
Debt instrument, maturity date | Dec. 1, 2023 | ||
Facility fee percentage | 0.75% | ||
Debt instrument, maturity date | Dec. 1, 2023 | ||
Interest rate description | The Term Loans bear interest at a floating rate equal to the greater of 5.25% and the prime rate as reported in the Wall Street Journal from time to time, plus 3.75% (9.0% as of December 31, 2021, the minimum interest rate). | ||
Debt instrument, interest rate at period end | 9.00% | ||
Interest frequency payments | monthly | ||
Repayment fee percentage | 4.00% | ||
Debt discount, amount | $ 600 | ||
Debt instrument, covenant description | The Loan Agreements contain customary affirmative covenants, including covenants regarding compliance with applicable laws and regulations, reporting requirements, payment of taxes and other obligations, and maintenance of insurance. Further, subject to certain exceptions, the Loan Agreements contain customary negative covenants limiting the ability of the Company to, among other things, sell assets, allow a change of control to occur (if the Term Loans are not repaid), make acquisitions, incur debt, grant liens, make investments, pay dividends or repurchase stock. The Company has maintained compliance with all such covenants to date. | ||
Interest expense, including amortization of the debt discount | $ 1,600 | ||
Term Loan outstanding | 16,000 | ||
Secured Term Loan Credit Facility [Member] | Accounts Payable [Member] | |||
Debt Instrument [Line Items] | |||
Accrued interest | $ 100 | ||
Secured Term Loan Credit Facility [Member] | Minimum [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, reference rate | 5.25% | ||
Debt instrument, basis spread on variable rate | 3.75% | ||
Secured Term Loan Credit Facility [Member] | Thereafter Second Anniversary of Closing Date [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of debt prepayment fee | 1.00% | ||
Secured Term Loan Credit Facility [Member] | Occurrence and During Continuance of Event of Default [Member] | |||
Debt Instrument [Line Items] | |||
Increase in applicable rate of interest | 5.00% | ||
Unsecured Loan [Member] | PPP Loan [Member] | JPMorgan Chase Bank, N.A. [Member] | CARES Act Of 2020 [Member] | |||
Debt Instrument [Line Items] | |||
Loans amount | $ 1,100 | ||
Interest rate | 0.98% | ||
Loan term | 2 years | ||
Date of early repayment of loan in full | Apr. 23, 2020 | ||
New Term Loan and Original Term Loan Member [Member] | Third Amendment [Member] | |||
Debt Instrument [Line Items] | |||
Additional term loan | $ 1,000 | ||
Debt instrument, maturity date | Apr. 1, 2026 | ||
New Term Loan and Original Term Loan Member [Member] | Third Amendment [Member] | First Anniversary Of New Closing Date [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of debt prepayment fee | 3.00% | ||
New Term Loan and Original Term Loan Member [Member] | Third Amendment [Member] | Second Anniversary Of New Closing Date [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of debt prepayment fee | 2.00% | ||
New Term Loan and Original Term Loan Member [Member] | Thereafter Second Anniversary of Closing Date [Member] | Third Amendment [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of debt prepayment fee | 1.00% |
Debt - Summary of Estimated Agg
Debt - Summary of Estimated Aggregate Amounts and Timing of Payments on Long-term Debt Obligations (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Long-term Debt, Unclassified [Abstract] | |
2022 | $ 0 |
2023 | 3,657 |
2024 | 5,486 |
2025 | 5,486 |
2026 | 2,011 |
Subtotal | 16,640 |
Unamortized discount | (643) |
Total long-term debt, net | $ 15,997 |
Leases - Additional Information
Leases - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2016 | |
Lessee Lease Description [Line Items] | ||
Operating lease, description | The Company has existing operating leases for certain office equipment and its facility with initial terms ranging from 36 months to 130 months. | |
Operating lease term | 130 months | |
Operating lease, option to extend | true | |
Operating lease, option to extend description | The facility lease has an option for the Company to extend the lease term for an additional five years; however, it is not reasonably certain the Company will exercise the option to renew when the lease term ends in 2027, and thus, the incremental term was excluded from the calculation of the lease liability and ROU asset. | |
Additional operating lease term | 5 years | 5 years |
Operating lease term ending year | 2027 | |
Operating lease, option to terminate | true | |
Operating lease, option to terminate description | The Company has the right to terminate the lease at the end of the 94th month of the lease term if it is acquired by a third party and pays an early termination fee. | |
Finance lease, description | In November 2021, the Company entered into a lease for certain computer equipment with an initial term of 48 months, which includes an option to purchase the equipment at the end of the lease term that is not reasonably certain to be exercised. | |
Computer Equipment [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease, description | In July 2021, the Company entered into a lease for certain equipment with an initial term of 36 months, which includes a purchase option at the end of the lease term based upon the then fair market value of the equipment. | |
Operating lease term | 36 months | |
Finance lease initial term | 48 months | |
Finance lease right-of-use asset amortization term | 4 years | |
Minimum [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease term | 36 months | |
Maximum [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease term | 130 months |
Leases - Summary of Lease Expen
Leases - Summary of Lease Expenses (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Lease expenses: | ||
Operating lease expenses | $ 3,162 | $ 3,137 |
Variable lease expenses | 934 | 793 |
Total lease expenses | $ 4,096 | $ 3,930 |
Leases - Future Minimum Annual
Leases - Future Minimum Annual Obligations under Finance and Operating Lease Commitments (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Operating Leases, 2022 | $ 3,365 | |
Operating Leases, 2023 | 3,464 | |
Operating Leases, 2024 | 3,554 | |
Operating Leases, 2025 | 3,642 | |
Operating Leases, 2026 | 3,751 | |
Operating Leases, Thereafter | 2,891 | |
Operating Leases, Total minimum lease payments | 20,667 | |
Operating Leases, Imputed interest | (5,111) | |
Operating Leases, Total | 15,556 | |
Operating Leases, Less: leases, current | $ (3,364) | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Less: leases, current | |
Operating Leases, Leases, net of current | $ 12,192 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Leases, net of current | |
Finance Leases, 2022 | $ 91 | |
Finance Leases, 2023 | 91 | |
Finance Leases, 2024 | 91 | |
Finance Leases, 2025 | 83 | |
Finance Leases, 2026 | 0 | |
Finance Leases, Thereafter | 0 | |
Finance Leases, Total minimum lease payments | 356 | |
Finance Leases, Imputed interest | (57) | |
Finance Leases, Total | 299 | |
Finance Leases, Less: leases, current | $ (91) | |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Less: leases, current | |
Finance Leases, Leases, net of current | $ 208 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Leases, net of current | |
2022 | $ 3,456 | |
2023 | 3,555 | |
2024 | 3,645 | |
2025 | 3,725 | |
2026 | 3,751 | |
Thereafter | 2,891 | |
Total minimum lease payments | 21,023 | |
Imputed interest | (5,168) | |
Total | 15,855 | |
Less: leases, current | (3,455) | $ (3,265) |
Leases, net of current | $ 12,400 | $ 13,847 |
Fair Value - Additional informa
Fair Value - Additional information (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value Measurements Nonrecurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 0 | $ 0 |
Liabilities measured at fair value | 0 | 0 |
Fair Value Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 71,493,000 | 78,854,000 |
Liabilities measured at fair value | $ 0 | $ 0 |
Fair Value - Fair Value Assets
Fair Value - Fair Value Assets Measured on a Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets | ||
Market Value | $ 0 | $ 55,576 |
U.S. Treasury Securities [Member] | ||
Assets | ||
Market Value | 55,086 | |
Certificates Of Deposit [Member] | ||
Assets | ||
Market Value | 490 | |
Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Assets, Fair Value Disclosure, Total | 71,493 | 78,854 |
Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 71,493 | 23,278 |
Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Market Value | 55,086 | |
Fair Value Measurements, Recurring [Member] | Certificates Of Deposit [Member] | ||
Assets | ||
Certificates of deposit | 490 | |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Assets, Fair Value Disclosure, Total | 71,493 | 78,364 |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | 71,493 | 23,278 |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Market Value | 55,086 | |
Level 1 [Member] | Fair Value Measurements, Recurring [Member] | Certificates Of Deposit [Member] | ||
Assets | ||
Certificates of deposit | ||
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Assets, Fair Value Disclosure, Total | 490 | |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | ||
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Market Value | ||
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | Certificates Of Deposit [Member] | ||
Assets | ||
Certificates of deposit | 490 | |
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | ||
Assets | ||
Assets, Fair Value Disclosure, Total | ||
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Assets | ||
Money market funds | ||
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets | ||
Market Value | ||
Level 3 [Member] | Fair Value Measurements, Recurring [Member] | Certificates Of Deposit [Member] | ||
Assets | ||
Certificates of deposit |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Shares of Common Stock Reserved for Future Issuance (Detail) - shares | Dec. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 28,883,700 | 18,698,302 |
Options to Purchase Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 11,707,568 | 9,842,744 |
Pre-funded Warrants [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 11,111,110 | 4,000,000 |
Unvested Restricted Stock Unit [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 1,650,250 | 0 |
Available Future Grant Year [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 1,500,062 | 2,553,854 |
2014 Employee Stock Purchase Plan [Member] | ||
Class of Stock [Line Items] | ||
Total common stock reserved for future issuance | 2,914,710 | 2,301,704 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2021 | Jul. 31, 2020 | Dec. 31, 2021 | |
Class of Stock [Line Items] | |||
Common stock sold in public offering | 8,298,890 | 17,275,000 | |
Shares issued price per Share | $ 2.25 | $ 3.25 | |
Net proceeds after deducting underwriters commission | $ 32.2 | $ 64.2 | |
Difference in offering price of warrants to offering price of common stock | $ 0.001 | ||
Ownership percentage of common stock | 4.99% | ||
Prefunded warrants exercised | 0 | ||
Pre-funded Warrants [Member] | |||
Class of Stock [Line Items] | |||
Shares issued price per Share | $ 2.249 | $ 3.249 | |
Warrants to purchase common stock | 7,111,110 | 4,000,000 | |
Difference in offering price of warrants to offering price of common stock | $ 0.001 |
Stock-Based Compensation and _3
Stock-Based Compensation and Equity Plans - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Jan. 01, 2022 | Dec. 20, 2017 | Dec. 31, 2021 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation vesting period | 1 year | |||
Common shares reserved for issuance | 28,883,700 | 18,698,302 | ||
Stock option granted | 2,965,000 | |||
Exchange of outstanding stock options, exercise price | $ 4.15 | $ 4.11 | ||
Common stock exercise price | $ 4.26 | |||
Unrecognized compensation costs related to stock options | $ 11.1 | |||
Remaining weighted-average vesting period | 2 years 6 months | |||
Restricted Stock Units (RSUs) [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost related to stock options | $ 2.8 | |||
Remaining weighted-average vesting period | 2 years 2 months 12 days | |||
Equity Incentive Plan 2014 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation vesting period | 4 years | |||
Contractual term of options | 10 years | |||
Exercise price, percentage of fair market value | 100.00% | |||
Annual increase in common shares reserved for issuance, percentage of total shares of common stock | 5.00% | |||
Changes in share issuance, description | Under the evergreen provision of the 2014 Plan, the number of shares available for issuance under the 2014 Plan includes an annual increase on the first day of each fiscal year equal to the lesser of (i) 2,500,000 shares; (ii) 5% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. | |||
Options available for grant | 1,500,062 | |||
Equity Incentive Plan 2014 [Member] | Subsequent Event [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Annual increase in common shares reserved for issuance | 2,500,000 | |||
Common shares reserved for issuance | 4,000,062 | |||
Equity Incentive Plan 2014 [Member] | Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation vesting period | 2 years | |||
Equity Incentive Plan 2014 [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share based compensation vesting period | 3 years | |||
Annual increase in common shares reserved for issuance | 2,500,000 | |||
2014 Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Annual increase in common shares reserved for issuance, percentage of total shares of common stock | 1.50% | |||
Changes in share issuance, description | issuance under the ESPP includes an annual increase on the first day of each fiscal year, equal to the lesser of (i) 800,000 shares; (ii) 1.5% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. | |||
Common shares reserved for issuance | 2,914,710 | 2,301,704 | ||
Eligible compensation contribution | 15.00% | |||
Offering periods under plan | 24 months | |||
Offering period description | The offering periods generally start on the first trading day on or after June 1 and December 1 of each year and end on the first trading day on or before June 1 and December 1 approximately twenty-four months later, and include six-month purchase periods. The Company accounts for stock-based compensation expense related to ESPP rights by estimating the fair value on the date of grant using the Black-Scholes-Merton option pricing model. | |||
Number of common stock issued pursuant to ESPP purchases | 707,333 | |||
Unrecognized compensation cost related to stock options | $ 0.2 | |||
Remaining weighted-average vesting period | 1 year 3 months 18 days | |||
2014 Employee Stock Purchase Plan [Member] | Subsequent Event [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common shares reserved for issuance | 3,714,710 | |||
2014 Employee Stock Purchase Plan [Member] | Minimum [Member] | Subsequent Event [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Annual increase in common shares reserved for issuance | 800,000 | |||
2014 Employee Stock Purchase Plan [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Annual increase in common shares reserved for issuance | 800,000 |
Stock-Based Compensation and _4
Stock-Based Compensation and Equity Plans - Stock Option Activity (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Options | |
Outstanding as of beginning of period | shares | 9,843 |
Granted | shares | 2,965 |
Exercised | shares | (3) |
Forfeited | shares | (1,097) |
Outstanding as of end of period | shares | 11,708 |
Options vested and expected to vest as of December 31, 2021 | shares | 11,708 |
Options exercisable as of December 31, 2021 | shares | 6,994 |
Weighted- Average Exercise Price | |
Outstanding as of beginning of period | $ / shares | $ 4.11 |
Granted | $ / shares | 4.26 |
Exercised | $ / shares | 2.11 |
Forfeited | $ / shares | 4.10 |
Outstanding as of end of period | $ / shares | 4.15 |
Options vested and expected to vest | $ / shares | 4.15 |
Options exercisable | $ / shares | $ 4.44 |
Weighted-Average Remaining Contractual Term (In Years) | |
Outstanding | 6 years 9 months 18 days |
Options vested and expected to vest | 6 years 9 months 18 days |
Options exercisable | 5 years 7 months 6 days |
Aggregate Intrinsic Value | |
Outstanding | $ | $ 460 |
Options vested and expected to vest | $ | 460 |
Options exercisable | $ | $ 348 |
Stock-Based Compensation and _5
Stock-Based Compensation and Equity Plans - Summary of Certain Information Regarding Stock Options (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |||
Weighted-average grant date fair value per share of options granted during the period | $ 3.32 | $ 2.68 | $ 1.64 |
Cash received from options exercised during the period | $ 6 | $ 206 | $ 5 |
Intrinsic value of options exercised during the period | $ 1 | $ 59 | $ 2 |
Stock-Based Compensation and _6
Stock-Based Compensation and Equity Plans - Summary of restricted stock unit activity (Details) - Restricted Stock [Member] shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding as of beginning of period | shares | 0 |
Granted | shares | 1,697 |
Vested | shares | 0 |
Forfeited | shares | 47 |
Outstanding as of end of period | shares | 1,650 |
Weighted- Average Grant Date Fair Value | |
Outstanding as of beginning of period | $ / shares | $ 0 |
Granted | $ / shares | 2.16 |
Vested | $ / shares | 0 |
Forfeited | $ / shares | 2.16 |
Outstanding as of end of period | $ / shares | $ 2.16 |
Stock-Based Compensation and _7
Stock-Based Compensation and Equity Plans - Weighted-Average Underlying Assumptions Used to Determine Fair Value of Stock Options and ESPP Rights (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 0.80% | 1.50% | 2.50% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility | 99.20% | 96.70% | 98.10% |
Expected term (in years) | 6 years | 6 years 1 month 6 days | 6 years 1 month 6 days |
Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 0.10% | 0.10% | 2.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility | 90.90% | 69.80% | 69.50% |
Expected term (in years) | 1 year 3 months 18 days | 1 year 3 months 18 days | 1 year 3 months 18 days |
Stock-Based Compensation and _8
Stock-Based Compensation and Equity Plans - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation | $ 7,397 | $ 6,111 | $ 4,890 |
Cost of Product Sales [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation | 3 | 13 | 12 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation | 3,355 | 2,456 | 2,085 |
Selling, General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation | $ 4,039 | $ 3,642 | $ 2,793 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional information (Detail) - ALK-Abelló, Inc. [Member] - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Decrease in selling general and administrative expenses | $ 0.5 | $ 0.3 |
Minimum [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Share of gross profits, percentage | 50.00% |
Disposition of a Business - Add
Disposition of a Business - Additional Information (Details) - USD ($) | May 28, 2021 | Dec. 31, 2021 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Gain (Loss) on sale of assets | $ 23,000 | |
Upfront Payment [Member] | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Payment to acquire worldwide rights | $ 800,000 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 99,450 | $ 88,013 |
Research and development credits | 11,107 | 9,985 |
Depreciation and amortization | 7,940 | 10,212 |
Accrued expenses | 694 | 850 |
Lease liabilities | 3,373 | 3,816 |
Stock compensation | 4,083 | 3,856 |
Other, net | 94 | 234 |
Total deferred tax assets | 126,741 | 116,966 |
Less: valuation allowance | (124,040) | (113,826) |
Total deferred tax assets, net of valuation allowance | 2,701 | 3,140 |
Deferred tax liability: | ||
Right-of-use assets | (2,701) | (3,140) |
Total deferred tax liability | (2,701) | (3,140) |
Total | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2018 | |
Income Taxes [Line Items] | ||||
Valuation allowance | $ 124,040,000 | $ 113,826,000 | ||
Net operating loss carryforwards | $ 196,100,000 | |||
Percentage of taxable income limitation | 80.00% | |||
Unrecognized tax benefit, income tax penalties and interest accrued | 0 | 0 | ||
Unrecognized tax benefits, income tax penalties and interest expense | 0 | $ 0 | $ 0 | |
State and Local Jurisdiction [Member] | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 127,100,000 | |||
Net operating loss carryforwards, expiration | will begin to expire in 2030 | |||
Internal Revenue Service (IRS) [Member] | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 436,700,000 | |||
Net operating loss carryforwards, expiration | will begin to expire in 2030 | |||
Tax credit carryforwards | $ 13,400,000 | |||
Tax credit carryforwards, expiration | will begin expiring in 2030 | |||
California Franchise Tax Board [Member] | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards | $ 6,500,000 | |||
Tax credit carryforwards, expiration | indefinitely |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Expected Recovery of Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory rate | $ (10,748) | $ (9,393) | $ (9,382) |
State tax (net of federal benefit) | 500 | 334 | 299 |
Permanent items, other | 11 | 9 | 189 |
Stock compensation | 1,349 | 1,595 | 2,470 |
Other adjustments | (204) | 687 | 523 |
Research and development credits | (1,870) | (1,774) | (1,595) |
Uncertain tax positions | 748 | 710 | 638 |
Change in valuation allowance | 10,214 | 7,832 | 6,858 |
Provision for income taxes | $ 0 | $ 0 | $ 0 |
Income Taxes - Activity Related
Income Taxes - Activity Related to Gross Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Balance at the beginning of the year | $ 11,514 | $ 10,739 | $ 10,052 |
Adjustments related to prior year tax positions | (83) | (21) | (80) |
Increases related to current year tax positions | 885 | 796 | 767 |
Unrecognized Tax Benefits | $ 12,316 | $ 11,514 | $ 10,739 |