Cover
Cover - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Feb. 01, 2021 | |
Cover [Abstract] | ||
Document Type | 10-K | |
Document Annual Report | true | |
Document Period End Date | Dec. 31, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-39112 | |
Entity Registrant Name | OYSTER POINT PHARMA, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-1030955 | |
Entity Address, Address Line One | 202 Carnegie Center, Suite 109 | |
Entity Address, Postal Zip Code | 08540 | |
Entity Address, City or Town | Princeton | |
Entity Address, State or Province | NJ | |
Title of 12(b) Security | Common stock, par value $0.001 | |
Trading Symbol | OYST | |
Security Exchange Name | NASDAQ | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Central Index Key | 0001720725 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | FY | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Local Phone Number | 382-9032 | |
City Area Code | 609 | |
Entity Common Stock, Shares Outstanding | 25,909,694 | |
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement relating to the 2021 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. The proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, 2020. | |
Entity Public Float | $ 319.8 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current Assets | ||
Cash and cash equivalents | $ 192,585 | $ 139,147 |
Prepaid expenses and other current assets | 3,782 | 3,033 |
Total current assets | 196,367 | 142,180 |
Property and equipment, net | 804 | 181 |
Restricted cash | 61 | 51 |
Total right-of-use asset | 678 | 797 |
Assets, Total | 197,910 | 143,209 |
Current Liabilities | ||
Accounts payable | 2,279 | 507 |
Accrued expenses and other current liabilities | 8,285 | 4,596 |
Total lease liabilities | 418 | 296 |
Total current liabilities | 10,982 | 5,399 |
Total lease liabilities, non-current | 269 | 512 |
Total Liabilities | 11,251 | 5,911 |
Commitments and Contingencies (Note 9) | ||
Stockholders’ Equity | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized; none outstanding | 0 | 0 |
Common stock, $0.001 par value per share; 1,000,000,000 shares authorized, 25,890,490 and 21,366,950 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively | 26 | 21 |
Additional paid-in capital | 341,384 | 221,508 |
Accumulated deficit | (154,751) | (84,231) |
Total Stockholders’ Equity | 186,659 | 137,298 |
Total Liabilities and Stockholders’ Equity | $ 197,910 | $ 143,209 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Par value of preferred stock (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common stock shares issued (in shares) | 25,890,490 | 21,366,950 |
Common stock shares outstanding (in shares) | 25,890,490 | 21,366,950 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating expenses: | ||||||||||
Research and development | $ 11,707 | $ 8,210 | $ 8,554 | $ 11,340 | $ 15,034 | $ 8,088 | $ 8,101 | $ 2,405 | $ 39,811 | $ 33,628 |
Selling, general and administrative | 10,537 | 8,112 | 6,940 | 5,589 | 5,127 | 3,809 | 3,132 | 1,605 | 31,178 | 13,673 |
Total operating expenses | 22,244 | 16,322 | 15,494 | 16,929 | 20,161 | 11,897 | 11,233 | 4,010 | 70,989 | 47,301 |
Loss from operations | (22,244) | (16,322) | (15,494) | (16,929) | (20,161) | (11,897) | (11,233) | (4,010) | (70,989) | (47,301) |
Other income, net | 12 | 17 | 30 | 410 | 437 | 400 | 503 | 250 | 469 | 1,590 |
Net loss and comprehensive loss | $ (22,232) | $ (16,305) | $ (15,464) | $ (16,519) | $ (19,724) | $ (11,497) | $ (10,730) | $ (3,760) | $ (70,520) | $ (45,711) |
Net loss per share, basic and diluted (in dollars per share) | $ (2.92) | $ (9.97) | ||||||||
Weighted-average shares outstanding, basic and diluted (in shares) | 25,869,601 | 25,797,282 | 23,442,530 | 21,367,532 | 13,993,730 | 1,419,064 | 1,412,354 | 1,411,966 | 24,128,603 | 4,585,146 |
STATEMENTS OF REDEEMABLE CONVER
STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Series B Preferred Stock | Common Stock | Common StockUnvested restricted stock units | Additional Paid-In Capital | Accumulated Deficit |
Redeemable convertible preferred stock, beginning balance (in shares) at Dec. 31, 2018 | 7,611,691 | |||||
Redeemable convertible preferred stock, amount, beginning balance at Dec. 31, 2018 | $ 43,001 | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||
Issuance of Series B redeemable convertible preferred stock, net of issuance costs, (in shares) | 6,581,590 | |||||
Issuance of Series B redeemable convertible preferred stock, net of issuance cost, amount | $ 92,852 | |||||
Conversion of redeemable convertible preferred stock into common stock upon initial public offering (in shares) | (14,193,281) | |||||
Conversion of redeemable convertible preferred stock into common stock upon initial public offering | $ (135,853) | |||||
Redeemable convertible preferred stock, ending balance (in shares) at Dec. 31, 2019 | 0 | |||||
Redeemable convertible preferred stock, amount, ending balance at Dec. 31, 2019 | $ 0 | |||||
Beginning balance, common stock (in shares) at Dec. 31, 2018 | 1,411,966 | |||||
Beginning balance at Dec. 31, 2018 | (38,243) | $ 1 | $ 276 | $ (38,520) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (45,711) | (45,711) | ||||
Issuance of common stock upon offering, net of issuance costs (in shares) | 5,750,000 | |||||
Issuance of common stock upon offering, net of issuance costs | 82,102 | $ 6 | 82,096 | |||
Conversion of redeemable convertible preferred stock into common stock upon initial public offering (in shares) | 14,193,281 | |||||
Conversion of redeemable convertible preferred stock into common stock upon initial public offering | 135,853 | $ 14 | 135,839 | |||
Issuance of common stock upon exercise of stock options (in shares) | 11,703 | |||||
Issuance of common stock upon exercise of stock options | 31 | 31 | ||||
Stock-based compensation | $ 3,266 | 3,266 | ||||
Ending balance, common stock (in shares) at Dec. 31, 2019 | 21,366,950 | 21,366,950 | ||||
Ending balance at Dec. 31, 2019 | $ 137,298 | $ 21 | 221,508 | (84,231) | ||
Redeemable convertible preferred stock, ending balance (in shares) at Dec. 31, 2020 | 0 | |||||
Redeemable convertible preferred stock, amount, ending balance at Dec. 31, 2020 | $ 0 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (70,520) | (70,520) | ||||
Issuance of common stock upon offering, net of issuance costs (in shares) | 4,312,500 | |||||
Issuance of common stock upon offering, net of issuance costs | $ 112,625 | $ 5 | 112,620 | |||
Issuance of common stock upon exercise of stock options (in shares) | 175,030 | 175,030 | 36,010 | |||
Issuance of common stock upon exercise of stock options | $ 283 | 283 | ||||
Stock-based compensation | $ 6,973 | 6,973 | ||||
Ending balance, common stock (in shares) at Dec. 31, 2020 | 25,890,490 | 25,890,490 | ||||
Ending balance at Dec. 31, 2020 | $ 186,659 | $ 26 | $ 341,384 | $ (154,751) |
STATEMENTS OF REDEEMABLE CONV_2
STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Class of Stock [Line Items] | ||
Payments of Stock Issuance Costs | $ 361 | $ 0 |
Common Stock | ||
Class of Stock [Line Items] | ||
Payments of Stock Issuance Costs | $ 8,125 | 9,898 |
Series B Preferred Stock | Common Stock | ||
Class of Stock [Line Items] | ||
Payments of Stock Issuance Costs | $ 146 |
STATEMENT OF CASH FLOWS
STATEMENT OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (70,520) | $ (45,711) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 6,973 | 3,266 |
Depreciation | 77 | 19 |
Reduction in the carrying amount of the right-of-use assets | 384 | 166 |
Changes in assets and liabilities: | ||
Prepaid expenses and other assets | (381) | (2,623) |
Accounts payable | 1,773 | 38 |
Change in lease liabilities | (382) | (151) |
Accrued expenses and other current liabilities | (3,677) | (4,181) |
Net cash used in operating activities | (58,399) | (40,815) |
Cash flows from investing activities | ||
Capital expenditures | (700) | (200) |
Net cash used in investing activities | (700) | (200) |
Cash flows from financing activities | ||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | 0 | 92,852 |
Proceeds from initial public offering, net of issuance costs | 0 | 82,102 |
Proceeds from follow-on equity offering, net of issuance costs | 112,625 | 0 |
Payments of deferred offering costs | (361) | 0 |
Proceeds from the issuance of common stock upon exercise of stock options | 283 | 31 |
Net cash provided by financing activities | 112,547 | 174,985 |
Net increase in cash, cash equivalents and restricted cash | 53,448 | 133,970 |
Cash, cash equivalents and restricted cash at the beginning of the period | 139,198 | 5,228 |
Cash, cash equivalents and restricted cash at the end of the period | 192,646 | 139,198 |
Supplemental cash flow information | ||
Right-of-use for office space and office equipment acquired through leases | 320 | 897 |
Conversion of redeemable convertible preferred stock to common stock upon closing of the initial public offering | $ 0 | $ (135,853) |
Nature of Business, Basis of Pr
Nature of Business, Basis of Presentation and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Nature of Business, Basis of Presentation and Significant Accounting Policies | Nature of Business, Basis of Presentation and Significant Accounting Policies Description of the Business Oyster Point Pharma, Inc. (the Company) is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of pharmaceutical therapies to treat ocular surface diseases. The Company’s principal office is located in Princeton, New Jersey. From inception through December 31, 2020, the Company has been primarily engaged in business planning, research, clinical development of its therapeutic product candidates, recruiting and raising capital. On December 17, 2020, the Company submitted a 505(b)(2) NDA to the FDA for its first lead product candidate, OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry disease. The Company expects to incur increased sales and marketing expenses with the commercialization of OC-01 (varenicline) nasal spray, if approved for sale, as well as increased research and development expenses as it develops additional product candidates. Since inception, the Company has incurred recurring losses and negative cash flows from operations. The Company generated net losses of $70.5 million and $45.7 million for the years ended December 31, 2020 and 2019, respectively, and had an accumulated deficit of $154.8 million as of December 31, 2020. The Company has historically financed its operations primarily through the sale and issuance of its securities. The Company completed its initial public offering (IPO) in November 2019 selling 5,750,000 shares of common stock raising aggregate net proceeds from the offering in the amount of $82.1 million. On May 19, 2020, the Company completed a follow-on equity offering selling 4,312,500 shares of common stock at a price of $28.00 per share. The net proceeds from the offering were $112.6 million. For further discussion on changes in the Company's capital structure, see Note 5, Stockholders' Equity. The Company had cash and cash equivalents of $192.6 million as of December 31, 2020. Management believes that the Company’s current cash and cash equivalents will be sufficient to fund its planned operations for at least 12 months from the filing date of this Annual Report on Form 10-K. Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP). Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenue and expenses in the financial statements and accompanying notes as of the date of the financial statements. On an ongoing basis, management evaluates its estimates, including those related to the valuation of stock awards, income taxes and certain research and development accruals. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from these estimates, and such differences could be material to the Company’s financial position and results of operations. Risks and Uncertainties The Company operates in a dynamic and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company related to intellectual property, product, regulatory, or other matters; and the Company’s ability to attract and retain employees necessary to support its growth. Product candidates developed by the Company will require approvals from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the Company. The Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of its product candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive regulatory approval. The Company will require additional funds to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources and there can be no assurance that the Company will be able to secure such additional financing on a timely basis, if at all, that will be sufficient to meet these needs. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs which would materially and adversely affect its business, financial condition and operations. The Company relies on single source manufacturers and suppliers for the supply of its product candidates. Disruption from these manufacturers or suppliers would have a negative impact on the Company’s business, financial position and results of operations. In addition, the Company is dependent upon the services of its employees, consultants and other third parties. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to be cash equivalents. As of December 31, 2020 and 2019, cash and cash equivalents consisted of cash on deposit with a bank denominated in U.S. dollars and investment in money market funds. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets that sum to the total of the same such amounts shown in the statements of cash flows (in thousands): Year ended December 31, 2020 2019 Cash and cash equivalents $ 192,585 $ 139,147 Restricted cash (a) 61 51 Cash, cash equivalents and restricted cash shown in the statements of cash flows $ 192,646 $ 139,198 (a) — Held in a separate bank account to support a letter of credit agreement related to the Company’s office leases, which expire in 2022. Property and Equipment Property and equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the related assets. Construction-in-progress reflects amounts incurred for property and equipment construction or improvements that have not yet been placed in service and are not depreciated or amortized. Repairs and maintenance are expensed when incurred. Upon retirement or sale, the cost of the assets disposed of and the related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in the determination of net loss. Estimated useful lives by major asset category are as follows: Office equipment 5 years Furniture and fixtures 7 years Leasehold improvements Shorter of lease term or estimated useful life Long-lived assets are tested for recoverability whenever events or circumstances indicate that the carrying amount may not be recoverable. Leases The Company determines if an arrangement is or contains a lease and the classification of that lease at inception of a contract. The Company’s operating and finance lease assets are included in right-of-use assets, net lease liabilities lease liabilities, non-current Right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the lease commencement date. Right-of-use assets are based on the corresponding lease liability adjusted for (i) payments made at or before the commencement date, (ii) initial direct costs incurred, and (iii) tenant incentives under the lease. The Company does not account for renewals or early terminations unless it is reasonably certain to exercise these options at commencement. Operating lease expense is recognized on a straight-line basis over the lease term. For finance leases, right of use assets are amortized on a straight-line basis over the shorter of the lease term or the estimated useful life of the leased assets. The Company accounts for lease and non-lease components as a single lease component for operating leases. The discount rate used to calculate the present value of the Company's leases is based on either an explicit rate stipulated in the contract (for finance leases) or the incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future payments. The Company’s incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, in an economic environment where the leased asset is located. The Company determines the incremental borrowing rate by considering various factors, such as its credit rating, interest rates of similar debt instruments of entities with comparable credit ratings, the lease term and the currency in which the lease was denominated. The Company does not record leases with terms of 12 months or less on the balance sheets. See Note 8, Leases, for additional information regarding the Company's operating and finance leases. Fair Value of Financial Instruments The carrying amounts for financial instruments consisting of cash equivalents, restricted cash, accounts payable and accrued liabilities approximate their fair value due to short-term maturities. See Note 2, Fair Value Measurements, for additional information on the Company's measurements of its financial instruments. Research and Development Research and development expenses primarily consist of CMOs and CROs related costs, costs relating to manufacturing clinical trial materials and pre-approval inventory, regulatory compliance costs, employee compensation and benefits, consulting, laboratory supplies, product licenses, sponsored research, as well as facility-related expenses and depreciation. All research and development costs are charged to research and development expenses within the statements of operations and comprehensive loss as incurred. Payments associated with licensing agreements to acquire exclusive licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternate commercial use are also expensed as incurred. The Company’s accruals for research and development activities performed by third parties are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on the balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accruals accordingly. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered. Net Loss per Common Share Basic and diluted net loss per common share is presented in conformity with ASC Topic 260, Earning Per Share for all periods presented. In accordance with this guidance, basic and diluted net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period. Basic net loss per share is calculated without consideration of potentially dilutive securities, while diluted net loss per share accounts for potentially dilutive securities outstanding for the period. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718. The fair value method requires the Company to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model. The Company uses the Black-Scholes pricing model to estimate the fair value of options granted that are expensed on a straight-line basis over the vesting period. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes option-pricing model, require the input of several assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. Income Taxes The Company accounts for income taxes in accordance with ASC 740, using the asset and liability method whereby deferred tax asset and liability amounts are determined based on the differences between the financial reporting and tax bases of assets and liabilities. The differences are measured using the enacted tax rates and laws that are in effect for the year in which they are expected to affect taxable income. Valuation allowances are established where necessary to reduce deferred tax assets to the amounts expected to be realized. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination that the position meets the more-likely-than-not threshold and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether the factors underlying the more-likely-than-not threshold assertion have changed and the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. The Company's policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that would result from transactions and economic events other than those with stockholders. There have been no items qualifying as other comprehensive income (loss) and, therefore, for all periods presented, the Company’s comprehensive loss was the same as its reported net loss. Reclassification Certain prior year amounts have been reclassified for comparative purposes. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its accounting standard codifications (ASC) or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below. Recently adopted accounting pronouncements ASU 2019-12 — In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , or Topic 740, as amended, which simplifies various aspects related to the accounting for income taxes. This ASU removes exceptions to the general principles in Topic 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. For public companies, this ASU is effective for interim and annual reporting periods beginning after December 15, 2020. Early adoption is permitted. The Company adopted ASU 2019-12 in the second quarter of 2020 and its adoption did not have a material effect on the Company's financial statements and related disclosures. ASU 2018-15 — In August 2018, the FASB issued ASU 2018-15, Intangibles - Goodwill and Other (Subtopic 350): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract, or Topic 350, as amended, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. For public companies, this ASU is effective for interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. The Company adopted ASU 2018-15 effective January 1, 2020 and its adoption did not have a material effect on the Company's financial statements and related disclosures. ASU 2018-13 — In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , or Topic 820, as amended, which modifies the disclosure requirements on fair value measurements. This ASU removes the requirement to disclose: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels; and the valuation processes for Level 3 fair value measurements. For public business entities, this ASU is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company adopted ASU 2018-13 effective January 1, 2020 and its adoption did not have a material effect on the Company’s financial statements and related disclosures. Recently issued accounting pronouncements not yet adopted ASU 2020-10 — In October 2020, the FASB issued ASU 2020-10, Codification Improvements , which updates various codification topics by clarifying or improving disclosure requirements to align with the SEC’s regulations. The amendments in the ASU 2020-10 are effective for annual periods beginning after December 15, 2020, for public business entities. The Company plans to adopt ASU 2020-10 on January 1, 2021 and does not expect that the adoption of this update to have a material effect on the Company’s consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company assesses the fair value of financial instruments as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. As of December 31, 2020, financial assets measured and recognized at fair value were as follows (in thousands): Fair Value Measurements at December 31, 2020 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets Money market funds $ 191,585 $ — $ — $ 191,585 Total fair value of assets $ 191,585 $ — $ — $ 191,585 As of December 31, 2019, financial assets measured and recognized at fair value were as follows (in thousands): Fair Value Measurements at December 31, 2019 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets Money market funds $ 138,147 $ — $ — $ 138,147 Total fair value of assets $ 138,147 $ — $ — $ 138,147 Money market funds are included in cash and cash equivalents on the Company's balance sheets. They are valued using quoted market prices and therefore are classified within Level 1 of the fair value hierarchy. The carrying amounts reflected in the Company's balance sheets for cash and cash equivalents, prepaid expenses and other current assets, restricted cash, accounts payable and accrued expenses and other liabilities approximate their fair values due to their short-term nature. There were no financial liabilities measured and recognized at fair value as of December 31, 2020 and December 31, 2019. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk, such as money market funds, are included in cash and cash equivalents on the balance sheets. The Company attempts to minimize the risks related to cash and |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): December 31, 2020 2019 Leasehold improvements $ 158 $ 105 Office equipment 68 45 Furniture and fixtures 73 50 Construction-in-progress 601 — Total property and equipment 900 200 Accumulated depreciation (96) (19) Property and equipment, net $ 804 $ 181 |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2020 2019 Accrued compensation $ 3,500 $ 1,214 Accrued professional services 1,244 1,163 Accrued research and development expense 3,541 2,219 Accrued expenses and other current liabilities $ 8,285 $ 4,596 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock The Company is authorized to issue 1,000,000,000 shares of common stock, at a par value of $0.001 per share. Each share of common stock is entitled to one vote. The Company reserved common stock for future issuance as follows: December 31, 2020 2019 Outstanding options under the 2016 Plan 2,567,566 2,748,434 Outstanding options under the 2019 Plan 918,145 29,466 Equity awards available for grant under the 2019 Plan 1,790,106 2,747,047 Unvested restricted stock units (RSUs) under the 2019 Plan 61,215 23,125 Shares reserved for purchase under the ESPP (a) 270,000 270,000 Total 5,607,032 5,818,072 (a) — Employee Stock Purchase Plan approved in October 2019, as further described in Note 6 , Equity Incentive Plans . Changes in Capital Structure On May 19, 2020, the Company completed a follow-on public offering selling 4,312,500 shares of common stock at a price to the public of $28.00 per share. The net proceeds from the offering were $112.6 million. On November 4, 2019, upon the closing of the IPO, all outstanding shares of redeemable convertible preferred stock were converted into an aggregate of 14,193,281 shares of the Company’s common stock and $135.9 million of mezzanine equity was reclassified to common stock and additional paid-in capital. As of December 31, 2020 and December 31, 2019, there were no shares of redeemable convertible preferred stock issued and outstanding. In October 2019, the Company effected a 2.832861-for-1 reverse stock split of the Company’s common stock and redeemable convertible preferred stock. The par values of the common stock and redeemable convertible preferred stock were not adjusted as a result of the reverse stock split. Accordingly, all common stock, redeemable convertible preferred stock, stock options, and related per share amounts for the period through October 18, 2019 have been retroactively adjusted to give effect to the reverse stock split. On February 15, 2019, the Company executed the Series B Preferred Stock Purchase Agreement to sell 6,581,590 shares of Series B redeemable convertible preferred stock. In February and April 2019, the Company received gross cash proceeds of $85.0 million and $8.0 million, respectively, from the sale of Series B redeemable convertible preferred stock. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Equity Incentive Plans | Equity Incentive Plans In October 2019, the Company’s Board of Directors (BOD) and stockholders approved the 2019 Equity Incentive Plan (the 2019 Plan). The 2019 Plan provides for the granting of stock options, restricted stock, restricted stock units, stock appreciation rights, performance units, and performance shares to the Company's employees, directors, and others. The exercise price of an incentive stock option (ISO) and non-qualified stock option (NSO) shall not be less than 100% of the estimated fair value of the shares on the date of grant, as determined by the BOD. The exercise price of an ISO granted to a 10% stockholder shall not be less than 110% of the estimated fair value of the shares on the date of grant, as determined by the BOD. To date, outstanding options have a term of 10 years and generally vest over a four-year period with 25% vested after the first year and monthly vesting thereafter. In October 2019, the Company’s BOD and stockholders approved the 2019 Employee Stock Purchase Plan (the ESPP), which qualifies as an "employee stock purchase plan" under Section 423 of the Internal Revenue Code, and pursuant to which 270,000 shares of common stock were reserved for future issuance. The ESPP is designed to enable eligible employees to purchase shares of the Company's common stock at a discount on a periodic basis through payroll deductions. There were no ESPP purchases during the year ended December 31, 2020 and 2019, respectively. Stock Options The following table summarizes stock option activity under the 2016 Plan and the 2019 Plan during the year ended December 31, 2020 (in thousands, except share, contractual term and per share data): Outstanding Options Number of Shares Underlying Outstanding Options Weighted- Average Exercise Price Weighted-Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2020 2,777,900 $ 4.59 8.7 $ 55,146 Options granted 891,529 28.22 — Options exercised (175,030) 1.62 4,370 Options canceled (8,688) 20.02 91 Outstanding at December 31, 2020 3,485,711 $ 10.74 8.2 $ 36,506 Vested and exercisable as of December 31, 2020 1,556,245 $ 3.46 7.5 $ 23,914 Vested and expected to vest as of December 31, 2020 3,485,711 $ 10.74 8.2 $ 36,506 During the years ended December 31, 2020 and 2019, the Company granted options with a weighted-average grant date fair value of $20.41 and $8.62 per share, respectively. The fair value of options that vested during the years ended December 31, 2020 and 2019 was $3.2 million and $2.5 million, respectively. As of December 31, 2020, the total unrecognized stock-based compensation expense for stock options was $21.6 million, which is expected to be recognized over a weighted average period of 3.0 years. Restricted Stock Units The company issues restricted stock units (RSUs) with terms of one year to three years, subject to continuing services to be provided to the Company. The value of an RSU award is based on the Company's stock price on the date of the grant. Activity with respect to the Company's restricted stock units during the year ended December 31, 2020 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Units Weighted Average Grant Date Fair Value per Unit Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2020 23,125 $ 16.00 2.8 $ 565 Restricted stock units granted 74,100 27.01 2,001 Restricted stock units vested (36,010) 25.34 811 Restricted stock units canceled — — — Outstanding at December 31, 2020 61,215 $ 23.83 1.4 $ 1,152 Unvested and expected to vest as of December 31, 2020 61,215 $ 23.83 1.4 $ 1,152 During the years ended December 31, 2020 and 2019, the Company granted RSUs with a weighted-average grant date fair value of $27.01 and $16.00 per unit, respectively. The fair value of RSUs vested during the year ended December 31, 2020 was $0.9 million. No RSUs vested during the year ended December 31, 2019. As of December 31, 2020, the total unrecognized stock-based compensation expense for RSUs was $1.3 million, which is expected to be recognized over a weighted average period of 1.3 years. Stock-Based Compensation Expense The following table is a summary of stock-based compensation expense by function recognized (in thousands): Year Ended December 31, 2020 2019 Research and development $ 966 $ 579 Selling, general and administrative 6,007 2,687 Total stock-based compensation $ 6,973 $ 3,266 Fair Value of Options Granted Prior to the IPO, the fair value of the Company’s common stock underlying the stock options was determined by the BOD with assistance from management and, in part, on input from an independent third-party valuation firm. The BOD determined the fair value of common stock by considering a number of objective and subjective factors, including valuations of comparable companies, sales of convertible preferred stock, operating and financial performance, the lack of liquidity of the Company’s common stock and the general and industry-specific economic outlook. Subsequent to the IPO, the fair value of the Company’s common stock is based on the closing quoted market price of its common stock as reported by the NASDAQ Global Select Market on the date of grant. In determining fair value of the stock options granted, the Company uses the Black-Scholes model, which requires the input of several assumptions. These assumptions include: estimating the length of time employees will retain their vested stock options before exercising them (expected term), the estimated volatility of the Company’s common stock price over the expected term (expected volatility), risk-free interest rate and expected dividend rate. Changes in the following assumptions can materially affect the estimate of fair value and ultimately how much stock-based compensation expense is recognized. Expected term. The expected term is calculated using the simplified method which is used when there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the mid-point between the vesting date and the end of the contractual term. Expected volatility . As the Company has a limited trading history of its common stock, the expected volatility is estimated based on the third quartile of the range of the observed volatilities for comparable publicly traded biotechnology and pharmaceutical related companies over a period equal to the expected term of the stock option grants. The comparable companies are chosen based on industry, stage of development, size and financial leverage of potential comparable companies. Risk-free interest rate . The risk-free interest rate is based on the implied yield currently available on U.S. Treasury zero-coupon issues with a remaining term equivalent to the expected term of the stock award. Expected dividend rate. The Company has not paid and does not anticipate paying any dividends in the near future. Accordingly, the Company has estimated the dividend yield to be zero. The fair value of options granted were calculated using the weighted average assumptions set forth below: Year Ended December 31, 2020 2019 Expected volatility 82.0% - 118.0% 69.0% - 84.0% Risk-free interest rate 0.36% - 1.40% 1.48% - 2.38% Dividend yield —% —% Expected term 6.08 years 5.04 - 6.08 years |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per ShareThe following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data): Year Ended December 31, 2020 2019 Numerator: Net loss $ (70,520) $ (45,711) Denominator: Weighted-average shares outstanding, basic and diluted 24,128,603 4,585,146 Net loss per share, basic and diluted $ (2.92) $ (9.97) The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: December 31, 2020 2019 Options to purchase common stock 3,485,711 2,777,900 Unvested restricted stock units 61,215 23,125 Total 3,546,926 2,801,025 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | Leases Lease Obligations In April 2019, the Company entered into a non-cancelable operating lease for office space in Princeton, New Jersey, commencing on July 1, 2019, for a period of three years from the commencement date. In January 2020, the Company amended this lease to include additional office space, with the same terms as the original lease. Total future minimum lease payments under this amendment are $0.7 million as of December 31, 2020 . The total lease payments required over the life of this lease are $1.2 million. The remaining lease term was 1.6 years as of December 31, 2020. Rent expense was $0.4 million and $0.2 million for the year ended December 31, 2020 and 2019, respectively. The Company's variable lease payments primarily consist of maintenance and other operating expenses from its real estate leases. Variable lease payments are excluded from the right of use assets and lease liabilities and are recognized in the period in which the obligation for those payments is incurred. The lease terms include the option to extend or terminate the lease for one additional period of three years. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company leases certain office equipment under finance leases with remaining lease terms of 1.7 years to 2.3 years. At the commencement date, the Company determined the amount of lease liability using a discount rate of 3%, which management determined represents the rate implicit in the lease. Interest expense and amortization expense for the finance leases were immaterial for the years ended December 31, 2020 and 2019, respectively. Supplemental balance sheet information for the leases is as follows (in thousands): December 31, 2020 December 31, 2019 Operating lease right-of-use asset $ 644 $ 783 Finance lease right-of-use asset 34 14 Total right-of-use asset $ 678 $ 797 Operating lease liabilities $ 400 $ 290 Finance lease liabilities 18 6 Total lease liabilities $ 418 $ 296 Operating lease liabilities, non-current $ 250 $ 500 Finance lease liabilities, non-current 19 12 Total lease liabilities, non-current $ 269 $ 512 The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of December 31, 2020 Finance Leases Operating Leases Total 2021 $ 18 $ 432 $ 450 2022 16 255 271 2023 4 — 4 Total undiscounted cash flows 38 687 725 Less: imputed interest (1) (37) (38) Total lease liability 37 650 687 Less: current portion (18) (400) (418) Lease liability $ 19 $ 250 $ 269 As of December 31, 2019 Total 2020 $ 319 2021 316 2022 186 Total undiscounted cash flows 821 Less: imputed interest (13) Total lease liability 808 Less: current portion (296) Lease liability $ 512 In February 2021, the Company entered into a lease agreement for laboratory and office space in New Jersey for a three-year term beginning on March 1, 2021 and ending on February 29, 2024. Total future minimum lease payments under this agreement are $0.4 million. |
Leases | Leases Lease Obligations In April 2019, the Company entered into a non-cancelable operating lease for office space in Princeton, New Jersey, commencing on July 1, 2019, for a period of three years from the commencement date. In January 2020, the Company amended this lease to include additional office space, with the same terms as the original lease. Total future minimum lease payments under this amendment are $0.7 million as of December 31, 2020 . The total lease payments required over the life of this lease are $1.2 million. The remaining lease term was 1.6 years as of December 31, 2020. Rent expense was $0.4 million and $0.2 million for the year ended December 31, 2020 and 2019, respectively. The Company's variable lease payments primarily consist of maintenance and other operating expenses from its real estate leases. Variable lease payments are excluded from the right of use assets and lease liabilities and are recognized in the period in which the obligation for those payments is incurred. The lease terms include the option to extend or terminate the lease for one additional period of three years. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company leases certain office equipment under finance leases with remaining lease terms of 1.7 years to 2.3 years. At the commencement date, the Company determined the amount of lease liability using a discount rate of 3%, which management determined represents the rate implicit in the lease. Interest expense and amortization expense for the finance leases were immaterial for the years ended December 31, 2020 and 2019, respectively. Supplemental balance sheet information for the leases is as follows (in thousands): December 31, 2020 December 31, 2019 Operating lease right-of-use asset $ 644 $ 783 Finance lease right-of-use asset 34 14 Total right-of-use asset $ 678 $ 797 Operating lease liabilities $ 400 $ 290 Finance lease liabilities 18 6 Total lease liabilities $ 418 $ 296 Operating lease liabilities, non-current $ 250 $ 500 Finance lease liabilities, non-current 19 12 Total lease liabilities, non-current $ 269 $ 512 The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of December 31, 2020 Finance Leases Operating Leases Total 2021 $ 18 $ 432 $ 450 2022 16 255 271 2023 4 — 4 Total undiscounted cash flows 38 687 725 Less: imputed interest (1) (37) (38) Total lease liability 37 650 687 Less: current portion (18) (400) (418) Lease liability $ 19 $ 250 $ 269 As of December 31, 2019 Total 2020 $ 319 2021 316 2022 186 Total undiscounted cash flows 821 Less: imputed interest (13) Total lease liability 808 Less: current portion (296) Lease liability $ 512 In February 2021, the Company entered into a lease agreement for laboratory and office space in New Jersey for a three-year term beginning on March 1, 2021 and ending on February 29, 2024. Total future minimum lease payments under this agreement are $0.4 million. |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies License Agreement The Company is party to a non-exclusive patent license agreement with Pfizer, which granted the Company non-exclusive rights under Pfizer’s patent rights covering varenicline tartrate to develop, manufacture, and commercialize the OC-01 (varenicline) nasal spray product. Under the terms of the agreement, the Company made an upfront payment to Pfizer of $5 million during the year ended December 31, 2019. If the Company commercializes OC-01 (varenicline) nasal spray, it may be required to pay a single milestone payment in low double-digit millions and tiered royalties on net sales of OC-01 at percentages ranging from the mid-single digits to the mid-teens. The royalty obligation to Pfizer would commence upon the first commercial sale of OC-01 (varenicline) nasal spray and expire upon the later of (a) the expiration of all regulatory or data exclusivity granted to Pfizer in connection with varenicline in the United States; and (b) the expiration or abandonment of the last valid claims of the licensed patents. No milestone was achieved or probable to be achieved or royalties payable accrued as of December 31, 2020 and 2019. Contingencies |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company did not record a federal or state income tax provision or benefit for the for the years ended December 31, 2020 and December 31, 2019 as it has incurred net losses since inception. In addition, the net deferred tax assets generated from net operating losses are fully offset by a valuation allowance as the Company believes it is not more likely than not that the benefit will be realized. The Company had an effective tax rate of 0% for the years ended December 31, 2020 and 2019. The provision for income taxes differs from the amount expected by applying the federal statutory rate to the loss before taxes as follows: Year Ended December 31, 2020 2019 Federal statutory income tax rate 21.0 % 21.0 % State taxes (tax effected) 7.7 % 8.5 % Research tax credit 1.7 % 3.3 % Other permanent differences 0.3 % (2.0) % Change in valuation allowance (30.7) % (30.8) % Provision for income taxes — % — % The components of the Company’s net deferred tax assets and liabilities as of December 31, 2020 and 2019, were as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 29,786 $ 12,454 Credits 3,836 2,408 Tangible and intangible assets 2,666 1,977 Lease liability 195 227 Stock compensation 1,737 253 Accruals and Reserves 840 36 Gross deferred tax assets 39,060 17,355 Less: Valuation allowance (38,051) (16,423) Deferred tax assets, net of valuation allowance 1,009 932 Deferred tax liabilities: Prepaids (817) (708) Right of use asset (192) (224) Net deferred tax assets $ — $ — Deferred Tax Assets and Valuation Allowance Recognition of deferred tax assets is appropriate when realization of such assets is more likely than not. Based upon the weight of available evidence, which includes the Company’s historical operating performance and the U.S. cumulative net losses in all prior periods, the Company has provided a full valuation allowance against its U.S. deferred tax assets. The Company’s valuation allowance increased by $21.6 million and $10.7 million for the years ended December 31, 2020, and 2019, respectively. The increases to the Company's valuation allowance for both years related to the losses generated during the periods. NOL Carryforwards For the years ended December 31, 2020 and 2019, the Company had $120.6 million and $59.1 million of U.S. federal net operating losses, respectively. Certain U.S. federal net operating loss carryforwards will begin to expire, if not utilized, in 2035. Included in the U.S. federal net operating loss carryforwards are $116.1 million and $54.6 million as of December 31, 2020 and 2019, respectively, of net operating loss carryforwards, which are not subject to expiration. However, the deductibility of such net operating loss carryforwards will be limited in future years. For the years ended December 31, 2020 and 2019, the Company had state net operating loss carryforwards of $123.9 million and $60.7 million, respectively which generally begin to expire in the year 2035. Utilization of the net operating loss carryforwards may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state laws. The annual limitation may result in the expiration of net operating losses and credits before utilization. A Section 382 ownership change generally occurs if one or more stockholders or groups of stockholders who own at least 5% of the Company’s stock increase their ownership by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. Similar rules may apply under state tax laws. The Company has experienced an ownership change in prior periods. However, the change is not expected to cause a material limitation on the Company’s utilization of net operating loss carryforwards. Subsequent ownership changes may affect the limitation in future years. The Company is not in a taxable position and no net operating loss carryforwards have been utilized to date. Research and Experimentation Credit Carryforwards As of December 31, 2020 and 2019, the Company had federal research and experimentation credit carryforwards of $3.3 million and $2.1 million, respectively, and state research and experimentation credit carryforwards of $0.7 million and $0.4 million. The federal research and experimentation credit carryforwards expire beginning in the years 2037, and the state credit carryforwards are subject to varying expiration periods, the earliest beginning in year 2032. Uncertain Tax Positions As of December 31, 2020 and 2019, the Company had the following unrecognized tax benefits (in thousands): Year Ended December 31, 2020 2019 Balance at the beginning of the year $ 5,388 $ 1,989 Increases for tax positions taken during prior period 50 — Increases for tax positions taken during current period — 3,399 Balance at the end of the year $ 5,438 $ 5,388 The reversal of the unrecognized tax benefits would not affect the Company’s effective tax rate to the extent that it continues to maintain a full valuation allowance against its deferred tax assets. The Company does not expect any changes to uncertain tax benefits within the next twelve months. The Company files income tax returns in the U.S. federal, California, Florida, Massachusetts and New Jersey jurisdictions. Due to the Company’s net losses, its federal and state income tax returns are subject to examination for federal and state purposes since inception. If and when the Company claims net operating loss carryforwards from any prior year against future taxable income, those losses may be examined by the taxing authorities. As of December 31, 2020, there were no ongoing examinations. |
Unaudited Quarterly Financial I
Unaudited Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2020 | |
Condensed Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | Unaudited Quarterly Financial Information Below is a summary of the unaudited quarterly financial information for the year ended December 31, 2020 (in thousands, except share and per share data): Three months ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 Operating expenses: Research and development $ 11,340 $ 8,554 $ 8,210 $ 11,707 Selling, general and administrative 5,589 6,940 8,112 10,537 Total operating expenses 16,929 15,494 16,322 22,244 Loss from operations (16,929) (15,494) (16,322) (22,244) Other income, net 410 30 17 12 Net loss and comprehensive loss $ (16,519) $ (15,464) $ (16,305) $ (22,232) Basic and diluted net loss per share $ (0.77) $ (0.66) $ (0.63) $ (0.86) Weighted average shares outstanding 21,367,532 23,442,530 25,797,282 25,869,601 Below is a summary of the unaudited quarterly financial information for the year ended December 31, 2019 (in thousands, except share and per share data): Three months ended March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019 Operating expenses: Research and development $ 2,405 $ 8,101 $ 8,088 $ 15,034 Selling, general and administrative 1,605 3,132 3,809 5,127 Total operating expenses 4,010 11,233 11,897 20,161 Loss from operations (4,010) (11,233) (11,897) (20,161) Other income, net 250 503 400 437 Net loss and comprehensive loss $ (3,760) $ (10,730) $ (11,497) $ (19,724) Basic and diluted net loss per share $ (2.66) $ (7.60) $ (8.10) $ (1.41) Weighted average shares outstanding 1,411,966 1,412,354 1,419,064 13,993,730 Per share amounts for each quarter have been calculated separately. Accordingly, quarterly amounts may not add to annual amounts. |
Nature of Business, Basis of _2
Nature of Business, Basis of Presentation and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP). |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenue and expenses in the financial statements and accompanying notes as of the date of the financial statements. On an ongoing basis, management evaluates its estimates, including those related to the valuation of stock awards, income taxes and certain research and development accruals. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from these estimates, and such differences could be material to the Company’s financial position and results of operations. |
Risks and uncertainties | Risks and Uncertainties The Company operates in a dynamic and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company related to intellectual property, product, regulatory, or other matters; and the Company’s ability to attract and retain employees necessary to support its growth. Product candidates developed by the Company will require approvals from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the Company. The Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of its product candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive regulatory approval. The Company will require additional funds to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources and there can be no assurance that the Company will be able to secure such additional financing on a timely basis, if at all, that will be sufficient to meet these needs. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs which would materially and adversely affect its business, financial condition and operations. The Company relies on single source manufacturers and suppliers for the supply of its product candidates. Disruption from these manufacturers or suppliers would have a negative impact on the Company’s business, financial position and results of operations. In addition, the Company is dependent upon the services of its employees, consultants and other third parties. |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to be cash equivalents. As of December 31, 2020 and 2019, cash and cash equivalents consisted of cash on deposit with a bank denominated in U.S. dollars and investment in money market funds. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets that sum to the total of the same such amounts shown in the statements of cash flows (in thousands): Year ended December 31, 2020 2019 Cash and cash equivalents $ 192,585 $ 139,147 Restricted cash (a) 61 51 Cash, cash equivalents and restricted cash shown in the statements of cash flows $ 192,646 $ 139,198 (a) — Held in a separate bank account to support a letter of credit agreement related to the Company’s office leases, which expire in 2022. |
Property and Equipment | Property and Equipment Property and equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the related assets. Construction-in-progress reflects amounts incurred for property and equipment construction or improvements that have not yet been placed in service and are not depreciated or amortized. Repairs and maintenance are expensed when incurred. Upon retirement or sale, the cost of the assets disposed of and the related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in the determination of net loss. Estimated useful lives by major asset category are as follows: Office equipment 5 years Furniture and fixtures 7 years Leasehold improvements Shorter of lease term or estimated useful life |
Leases | Leases The Company determines if an arrangement is or contains a lease and the classification of that lease at inception of a contract. The Company’s operating and finance lease assets are included in right-of-use assets, net lease liabilities lease liabilities, non-current Right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the lease commencement date. Right-of-use assets are based on the corresponding lease liability adjusted for (i) payments made at or before the commencement date, (ii) initial direct costs incurred, and (iii) tenant incentives under the lease. The Company does not account for renewals or early terminations unless it is reasonably certain to exercise these options at commencement. Operating lease expense is recognized on a straight-line basis over the lease term. For finance leases, right of use assets are amortized on a straight-line basis over the shorter of the lease term or the estimated useful life of the leased assets. The Company accounts for lease and non-lease components as a single lease component for operating leases. The discount rate used to calculate the present value of the Company's leases is based on either an explicit rate stipulated in the contract (for finance leases) or the incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future payments. The Company’s incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, in an economic environment where the leased asset is located. The Company determines the incremental borrowing rate by considering various factors, such as its credit rating, interest rates of similar debt instruments of entities with comparable credit ratings, the lease term and the currency in which the lease was denominated. The Company does not record leases with terms of 12 months or less on the balance sheets. See Note 8, Leases, |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts for financial instruments consisting of cash equivalents, restricted cash, accounts payable and accrued liabilities approximate their fair value due to short-term maturities. See Note 2, Fair Value Measurements, for additional information on the Company's measurements of its financial instruments. |
Research and Development | Research and Development Research and development expenses primarily consist of CMOs and CROs related costs, costs relating to manufacturing clinical trial materials and pre-approval inventory, regulatory compliance costs, employee compensation and benefits, consulting, laboratory supplies, product licenses, sponsored research, as well as facility-related expenses and depreciation. All research and development costs are charged to research and development expenses within the statements of operations and comprehensive loss as incurred. Payments associated with licensing agreements to acquire exclusive licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternate commercial use are also expensed as incurred. The Company’s accruals for research and development activities performed by third parties are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on the balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accruals accordingly. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered. |
Net Loss per Common Share | Net Loss per Common Share Basic and diluted net loss per common share is presented in conformity with ASC Topic 260, Earning Per Share for all periods presented. In accordance with this guidance, basic and diluted net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period. Basic net loss per share is calculated without consideration of potentially dilutive securities, while diluted net loss per share accounts for potentially dilutive securities outstanding for the period. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718. The fair value method requires the Company to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model. The Company uses the Black-Scholes pricing model to estimate the fair value of options granted that are expensed on a straight-line basis over the vesting period. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes option-pricing model, require the input of several assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. |
Income Taxes | Income Taxes The Company accounts for income taxes in accordance with ASC 740, using the asset and liability method whereby deferred tax asset and liability amounts are determined based on the differences between the financial reporting and tax bases of assets and liabilities. The differences are measured using the enacted tax rates and laws that are in effect for the year in which they are expected to affect taxable income. Valuation allowances are established where necessary to reduce deferred tax assets to the amounts expected to be realized. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination that the position meets the more-likely-than-not threshold and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether the factors underlying the more-likely-than-not threshold assertion have changed and the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. The Company's policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. |
Comprehensive Loss | Comprehensive LossComprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that would result from transactions and economic events other than those with stockholders. There have been no items qualifying as other comprehensive income (loss) and, therefore, for all periods presented, the Company’s comprehensive loss was the same as its reported net loss |
Reclassification | Reclassification Certain prior year amounts have been reclassified for comparative purposes. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its accounting standard codifications (ASC) or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below. Recently adopted accounting pronouncements ASU 2019-12 — In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , or Topic 740, as amended, which simplifies various aspects related to the accounting for income taxes. This ASU removes exceptions to the general principles in Topic 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. For public companies, this ASU is effective for interim and annual reporting periods beginning after December 15, 2020. Early adoption is permitted. The Company adopted ASU 2019-12 in the second quarter of 2020 and its adoption did not have a material effect on the Company's financial statements and related disclosures. ASU 2018-15 — In August 2018, the FASB issued ASU 2018-15, Intangibles - Goodwill and Other (Subtopic 350): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract, or Topic 350, as amended, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. For public companies, this ASU is effective for interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. The Company adopted ASU 2018-15 effective January 1, 2020 and its adoption did not have a material effect on the Company's financial statements and related disclosures. ASU 2018-13 — In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , or Topic 820, as amended, which modifies the disclosure requirements on fair value measurements. This ASU removes the requirement to disclose: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels; and the valuation processes for Level 3 fair value measurements. For public business entities, this ASU is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company adopted ASU 2018-13 effective January 1, 2020 and its adoption did not have a material effect on the Company’s financial statements and related disclosures. Recently issued accounting pronouncements not yet adopted ASU 2020-10 — In October 2020, the FASB issued ASU 2020-10, Codification Improvements , which updates various codification topics by clarifying or improving disclosure requirements to align with the SEC’s regulations. The amendments in the ASU 2020-10 are effective for annual periods beginning after December 15, 2020, for public business entities. The Company plans to adopt ASU 2020-10 on January 1, 2021 and does not expect that the adoption of this update to have a material effect on the Company’s consolidated financial statements. |
Nature of Business, Basis of _3
Nature of Business, Basis of Presentation and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets that sum to the total of the same such amounts shown in the statements of cash flows (in thousands): Year ended December 31, 2020 2019 Cash and cash equivalents $ 192,585 $ 139,147 Restricted cash (a) 61 51 Cash, cash equivalents and restricted cash shown in the statements of cash flows $ 192,646 $ 139,198 (a) — Held in a separate bank account to support a letter of credit agreement related to the Company’s office leases, which expire in 2022. |
Property and Equipment | Estimated useful lives by major asset category are as follows: Office equipment 5 years Furniture and fixtures 7 years Leasehold improvements Shorter of lease term or estimated useful life Property and equipment, net consisted of the following (in thousands): December 31, 2020 2019 Leasehold improvements $ 158 $ 105 Office equipment 68 45 Furniture and fixtures 73 50 Construction-in-progress 601 — Total property and equipment 900 200 Accumulated depreciation (96) (19) Property and equipment, net $ 804 $ 181 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Financial assets measured and recognized at fair value | As of December 31, 2020, financial assets measured and recognized at fair value were as follows (in thousands): Fair Value Measurements at December 31, 2020 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets Money market funds $ 191,585 $ — $ — $ 191,585 Total fair value of assets $ 191,585 $ — $ — $ 191,585 As of December 31, 2019, financial assets measured and recognized at fair value were as follows (in thousands): Fair Value Measurements at December 31, 2019 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets Money market funds $ 138,147 $ — $ — $ 138,147 Total fair value of assets $ 138,147 $ — $ — $ 138,147 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Estimated useful lives by major asset category are as follows: Office equipment 5 years Furniture and fixtures 7 years Leasehold improvements Shorter of lease term or estimated useful life Property and equipment, net consisted of the following (in thousands): December 31, 2020 2019 Leasehold improvements $ 158 $ 105 Office equipment 68 45 Furniture and fixtures 73 50 Construction-in-progress 601 — Total property and equipment 900 200 Accumulated depreciation (96) (19) Property and equipment, net $ 804 $ 181 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of accrued liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2020 2019 Accrued compensation $ 3,500 $ 1,214 Accrued professional services 1,244 1,163 Accrued research and development expense 3,541 2,219 Accrued expenses and other current liabilities $ 8,285 $ 4,596 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Common stock reserved for future issuance | The Company reserved common stock for future issuance as follows: December 31, 2020 2019 Outstanding options under the 2016 Plan 2,567,566 2,748,434 Outstanding options under the 2019 Plan 918,145 29,466 Equity awards available for grant under the 2019 Plan 1,790,106 2,747,047 Unvested restricted stock units (RSUs) under the 2019 Plan 61,215 23,125 Shares reserved for purchase under the ESPP (a) 270,000 270,000 Total 5,607,032 5,818,072 (a) — Employee Stock Purchase Plan approved in October 2019, as further described in Note 6 , Equity Incentive Plans . |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Activity in stock option plan | Stock Options The following table summarizes stock option activity under the 2016 Plan and the 2019 Plan during the year ended December 31, 2020 (in thousands, except share, contractual term and per share data): Outstanding Options Number of Shares Underlying Outstanding Options Weighted- Average Exercise Price Weighted-Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2020 2,777,900 $ 4.59 8.7 $ 55,146 Options granted 891,529 28.22 — Options exercised (175,030) 1.62 4,370 Options canceled (8,688) 20.02 91 Outstanding at December 31, 2020 3,485,711 $ 10.74 8.2 $ 36,506 Vested and exercisable as of December 31, 2020 1,556,245 $ 3.46 7.5 $ 23,914 Vested and expected to vest as of December 31, 2020 3,485,711 $ 10.74 8.2 $ 36,506 |
Activity of restricted stock units | Activity with respect to the Company's restricted stock units during the year ended December 31, 2020 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Units Weighted Average Grant Date Fair Value per Unit Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2020 23,125 $ 16.00 2.8 $ 565 Restricted stock units granted 74,100 27.01 2,001 Restricted stock units vested (36,010) 25.34 811 Restricted stock units canceled — — — Outstanding at December 31, 2020 61,215 $ 23.83 1.4 $ 1,152 Unvested and expected to vest as of December 31, 2020 61,215 $ 23.83 1.4 $ 1,152 |
Stock-based compensation expense | The following table is a summary of stock-based compensation expense by function recognized (in thousands): Year Ended December 31, 2020 2019 Research and development $ 966 $ 579 Selling, general and administrative 6,007 2,687 Total stock-based compensation $ 6,973 $ 3,266 |
Schedule of valuation assumptions | The fair value of options granted were calculated using the weighted average assumptions set forth below: Year Ended December 31, 2020 2019 Expected volatility 82.0% - 118.0% 69.0% - 84.0% Risk-free interest rate 0.36% - 1.40% 1.48% - 2.38% Dividend yield —% —% Expected term 6.08 years 5.04 - 6.08 years |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data): Year Ended December 31, 2020 2019 Numerator: Net loss $ (70,520) $ (45,711) Denominator: Weighted-average shares outstanding, basic and diluted 24,128,603 4,585,146 Net loss per share, basic and diluted $ (2.92) $ (9.97) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: December 31, 2020 2019 Options to purchase common stock 3,485,711 2,777,900 Unvested restricted stock units 61,215 23,125 Total 3,546,926 2,801,025 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Supplemental Balance Sheet Information | Supplemental balance sheet information for the leases is as follows (in thousands): December 31, 2020 December 31, 2019 Operating lease right-of-use asset $ 644 $ 783 Finance lease right-of-use asset 34 14 Total right-of-use asset $ 678 $ 797 Operating lease liabilities $ 400 $ 290 Finance lease liabilities 18 6 Total lease liabilities $ 418 $ 296 Operating lease liabilities, non-current $ 250 $ 500 Finance lease liabilities, non-current 19 12 Total lease liabilities, non-current $ 269 $ 512 |
Maturities of lease liabilities | The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of December 31, 2020 Finance Leases Operating Leases Total 2021 $ 18 $ 432 $ 450 2022 16 255 271 2023 4 — 4 Total undiscounted cash flows 38 687 725 Less: imputed interest (1) (37) (38) Total lease liability 37 650 687 Less: current portion (18) (400) (418) Lease liability $ 19 $ 250 $ 269 As of December 31, 2019 Total 2020 $ 319 2021 316 2022 186 Total undiscounted cash flows 821 Less: imputed interest (13) Total lease liability 808 Less: current portion (296) Lease liability $ 512 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of effective income tax rate reconciliation | The Company had an effective tax rate of 0% for the years ended December 31, 2020 and 2019. The provision for income taxes differs from the amount expected by applying the federal statutory rate to the loss before taxes as follows: Year Ended December 31, 2020 2019 Federal statutory income tax rate 21.0 % 21.0 % State taxes (tax effected) 7.7 % 8.5 % Research tax credit 1.7 % 3.3 % Other permanent differences 0.3 % (2.0) % Change in valuation allowance (30.7) % (30.8) % Provision for income taxes — % — % |
Schedule of deferred tax assets and liabilities | The components of the Company’s net deferred tax assets and liabilities as of December 31, 2020 and 2019, were as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 29,786 $ 12,454 Credits 3,836 2,408 Tangible and intangible assets 2,666 1,977 Lease liability 195 227 Stock compensation 1,737 253 Accruals and Reserves 840 36 Gross deferred tax assets 39,060 17,355 Less: Valuation allowance (38,051) (16,423) Deferred tax assets, net of valuation allowance 1,009 932 Deferred tax liabilities: Prepaids (817) (708) Right of use asset (192) (224) Net deferred tax assets $ — $ — |
Schedule of unrecognized tax benefits roll forward | As of December 31, 2020 and 2019, the Company had the following unrecognized tax benefits (in thousands): Year Ended December 31, 2020 2019 Balance at the beginning of the year $ 5,388 $ 1,989 Increases for tax positions taken during prior period 50 — Increases for tax positions taken during current period — 3,399 Balance at the end of the year $ 5,438 $ 5,388 |
Unaudited Quarterly Data (Table
Unaudited Quarterly Data (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Condensed Financial Information Disclosure [Abstract] | |
Unaudited quarterly financial information | Below is a summary of the unaudited quarterly financial information for the year ended December 31, 2020 (in thousands, except share and per share data): Three months ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 Operating expenses: Research and development $ 11,340 $ 8,554 $ 8,210 $ 11,707 Selling, general and administrative 5,589 6,940 8,112 10,537 Total operating expenses 16,929 15,494 16,322 22,244 Loss from operations (16,929) (15,494) (16,322) (22,244) Other income, net 410 30 17 12 Net loss and comprehensive loss $ (16,519) $ (15,464) $ (16,305) $ (22,232) Basic and diluted net loss per share $ (0.77) $ (0.66) $ (0.63) $ (0.86) Weighted average shares outstanding 21,367,532 23,442,530 25,797,282 25,869,601 Below is a summary of the unaudited quarterly financial information for the year ended December 31, 2019 (in thousands, except share and per share data): Three months ended March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019 Operating expenses: Research and development $ 2,405 $ 8,101 $ 8,088 $ 15,034 Selling, general and administrative 1,605 3,132 3,809 5,127 Total operating expenses 4,010 11,233 11,897 20,161 Loss from operations (4,010) (11,233) (11,897) (20,161) Other income, net 250 503 400 437 Net loss and comprehensive loss $ (3,760) $ (10,730) $ (11,497) $ (19,724) Basic and diluted net loss per share $ (2.66) $ (7.60) $ (8.10) $ (1.41) Weighted average shares outstanding 1,411,966 1,412,354 1,419,064 13,993,730 |
Nature of Business, Basis of _4
Nature of Business, Basis of Presentation and Significant Accounting Policies (Details) - USD ($) $ / shares in Units, $ in Thousands | May 19, 2020 | Nov. 30, 2019 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||||||||||||
Price per share (in usd per share) | $ 28 | |||||||||||
Net loss | $ (22,232) | $ (16,305) | $ (15,464) | $ (16,519) | $ (19,724) | $ (11,497) | $ (10,730) | $ (3,760) | $ (70,520) | $ (45,711) | ||
Accumulated deficit | 154,751 | 84,231 | 154,751 | 84,231 | ||||||||
Cash and cash equivalents | $ 192,585 | $ 139,147 | $ 192,585 | $ 139,147 | ||||||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:AssetsAbstract | us-gaap:AssetsAbstract | us-gaap:AssetsAbstract | us-gaap:AssetsAbstract | ||||||||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:LiabilitiesCurrentAbstract | us-gaap:LiabilitiesCurrentAbstract | us-gaap:LiabilitiesCurrentAbstract | us-gaap:LiabilitiesCurrentAbstract | ||||||||
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:LiabilitiesNoncurrentAbstract | us-gaap:LiabilitiesNoncurrentAbstract | us-gaap:LiabilitiesNoncurrentAbstract | us-gaap:LiabilitiesNoncurrentAbstract | ||||||||
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:AssetsAbstract | us-gaap:AssetsAbstract | us-gaap:AssetsAbstract | us-gaap:AssetsAbstract | ||||||||
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:LiabilitiesCurrentAbstract | us-gaap:LiabilitiesCurrentAbstract | us-gaap:LiabilitiesCurrentAbstract | us-gaap:LiabilitiesCurrentAbstract | ||||||||
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:LiabilitiesNoncurrentAbstract | us-gaap:LiabilitiesNoncurrentAbstract | us-gaap:LiabilitiesNoncurrentAbstract | us-gaap:LiabilitiesNoncurrentAbstract | ||||||||
Office equipment | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Useful life of property and equipment | 5 years | |||||||||||
Furniture and fixtures | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Useful life of property and equipment | 7 years | |||||||||||
IPO | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Number of common stock sold and issued (in shares) | 5,750,000 | |||||||||||
Aggregate gross proceeds from offering | $ 82,100 | |||||||||||
Follow-on offering | ||||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||||
Number of common stock sold and issued (in shares) | 4,312,500 | |||||||||||
Aggregate gross proceeds from offering | $ 112,600 | |||||||||||
Price per share (in usd per share) | $ 28 |
Nature of Business, Basis of _5
Nature of Business, Basis of Presentation and Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents, Restricted Cash and Equivalents (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 192,585 | $ 139,147 | |
Restricted cash | 61 | 51 | |
Cash, cash equivalents and restricted cash shown in the statements of cash flows | $ 192,646 | $ 139,198 | $ 5,228 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of financial liabilities | $ 0 | $ 0 |
Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of assets | 191,585,000 | 138,147,000 |
Fair Value, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | 191,585,000 | 138,147,000 |
Fair Value, Recurring | Quoted Price in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of assets | 191,585,000 | 138,147,000 |
Fair Value, Recurring | Quoted Price in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | 191,585,000 | 138,147,000 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of assets | 0 | 0 |
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | 0 | 0 |
Fair Value, Recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of assets | 0 | 0 |
Fair Value, Recurring | Significant Unobservable Inputs (Level 3) | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | $ 0 | $ 0 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 900 | $ 200 |
Accumulated depreciation | (96) | (19) |
Property and equipment, net | 804 | 181 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 158 | 105 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 68 | 45 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 73 | 50 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 601 | $ 0 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 3,500 | $ 1,214 |
Accrued professional services | 1,244 | 1,163 |
Accrued research and development expense | 3,541 | 2,219 |
Accrued expenses and other current liabilities | $ 8,285 | $ 4,596 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Thousands | May 19, 2020USD ($)$ / sharesshares | Nov. 30, 2019USD ($)shares | Oct. 31, 2019 | Apr. 30, 2019USD ($) | Feb. 28, 2019USD ($) | Dec. 31, 2020USD ($)vote$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Feb. 15, 2019shares | Dec. 31, 2018shares |
Class of Stock [Line Items] | |||||||||
Common stock authorized (in shares) | 1,000,000,000 | 1,000,000,000 | |||||||
Common stock par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||||||
Number of votes per share | vote | 1 | ||||||||
Price per share (in usd per share) | $ / shares | $ 28 | ||||||||
Reclassifications of temporary to permanent Equity | $ | $ 135,900 | ||||||||
Redeemable convertible preferred stock, outstanding (in shares) | 0 | 0 | 7,611,691 | ||||||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | $ | $ 0 | $ 92,852 | |||||||
Stock split conversion ratio | 0.353 | ||||||||
Series B Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Conversion of preferred stock, shares converted (in shares) | 14,193,281 | ||||||||
Shares of redeemable convertible preferred stock authorized (in shares) | 6,581,590 | ||||||||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | $ | $ 8,000 | $ 85,000 | |||||||
IPO | |||||||||
Class of Stock [Line Items] | |||||||||
Number of common stock sold and issued (in shares) | 5,750,000 | ||||||||
Aggregate gross proceeds from offering | $ | $ 82,100 | ||||||||
Follow-on offering | |||||||||
Class of Stock [Line Items] | |||||||||
Number of common stock sold and issued (in shares) | 4,312,500 | ||||||||
Price per share (in usd per share) | $ / shares | $ 28 | ||||||||
Aggregate gross proceeds from offering | $ | $ 112,600 |
Stockholders' Equity - Reserved
Stockholders' Equity - Reserved Common Stock (Details) - shares | Dec. 31, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | ||
Outstanding options (in shares) | 3,485,711 | 2,777,900 |
Equity awards available to grant (in shares) | 61,215 | 23,125 |
Shares reserved for future issuance (in shares) | 5,607,032 | 5,818,072 |
2016 Plan | ||
Class of Stock [Line Items] | ||
Outstanding options (in shares) | 2,567,566 | 2,748,434 |
2019 Plan | ||
Class of Stock [Line Items] | ||
Outstanding options (in shares) | 918,145 | 29,466 |
Equity awards available for grant under the 2019 Plan (in shares) | 1,790,106 | 2,747,047 |
2019 ESPP | ||
Class of Stock [Line Items] | ||
Equity awards available to grant (in shares) | 270,000 | 270,000 |
Unvested restricted stock units | 2019 Plan | ||
Class of Stock [Line Items] | ||
Equity awards available to grant (in shares) | 61,215 | 23,125 |
Equity Incentive Plans (Details
Equity Incentive Plans (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares reserved for future issuance (in shares) | 5,607,032 | 5,818,072 | |
ESPP Purchases (in shares) | 0 | 0 | |
Weighted average grant date fair value (in dollars per share) | $ 28.22 | ||
Unrecognized stock-based compensation expense | $ 21.6 | ||
Weighted-average recognition period of unrecognized stock-based compensation expense (in years) | 3 years | ||
Stock-based compensation expense for RSUs | $ 1.3 | ||
Expected period for recognition of share-based compensation cost (in years) | 1 year 3 months 18 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period, Fair Value | $ 0.9 | ||
Fair value of options vested | $ 3.2 | $ 2.5 | |
Weighted-average grant-date fair value of options (in dollars per share) | $ 20.41 | ||
Restricted stock units granted (in dollars per share) | 27.01 | $ 8.62 | |
Stock options | 2019 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Percent of estimated fair value of shares | 100.00% | ||
Term of outstanding options (in years) | 10 years | ||
Vesting period of stock options (in years) | 4 years | ||
Incentive Stock Options | 2019 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Percent of estimated fair value of shares | 110.00% | ||
Percent of shares owned by individual stockholder | 10.00% | ||
Employee Stock | 2019 ESPP | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares reserved for future issuance (in shares) | 270,000 | ||
Unvested restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Restricted stock units granted (in dollars per share) | $ 27.01 | $ 16 |
Equity Incentive Plans - Option
Equity Incentive Plans - Option Activity During The Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares Underlying Outstanding Options | ||
Outstanding at beginning of period (in shares) | 2,777,900 | |
Options granted (in shares) | (891,529) | |
Options exercised (in shares) | (175,030) | |
Options canceled (in shares) | (8,688) | |
Outstanding at end of period (in shares) | 3,485,711 | 2,777,900 |
Vested and exercisable as of December 31, 2020 (in shares) | 1,556,245 | |
Vested and expected to vest as of December 31, 2020 (in shares) | 3,485,711 | |
Weighted- Average Exercise Price | ||
Beginning balance (in dollars per share) | $ 4.59 | |
Options granted (in dollars per share) | 28.22 | |
Options exercise price (in dollars per share) | 1.62 | |
Options canceled (in dollars per share) | 20.02 | |
Ending balance (in dollars per share) | 10.74 | $ 4.59 |
Vested and exercisable as of December 31, 2020 (in dollars per share) | 3.46 | |
Vested and expected to vest as of December 31, 2020 (in dollars per share) | $ 10.74 | |
Weighted-Average Remaining Contractual Term (Years) | ||
Weighted-average remaining contractual term (in years) | 8 years 2 months 12 days | 8 years 8 months 12 days |
Vested and exercisable as of December 31, 2020, Weighted-Average Remaining Contractual Term (in years) | 7 years 6 months | |
Vested and expected to vest as of December 31, 2020, weighted average exercise price | 8 years 2 months 12 days | |
Aggregate Intrinsic Value | ||
Aggregate intrinsic value, outstanding beginning balance | $ (55,146) | |
Aggregate intrinsic value, options exercised | 4,370 | |
Aggregate intrinsic value, options canceled | 91 | |
Aggregate intrinsic value, outstanding ending balance | 36,506 | $ 55,146 |
Vested and expected to vest as of December 31, 2020, aggregate intrinsic value | 36,506 | |
Vested and exercisable as of December 31, 2020, aggregate intrinsic value | $ 23,914 |
Equity Incentive Plans - RSU Ac
Equity Incentive Plans - RSU Activity During The Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares Underlying Outstanding Units | ||
Outstanding at beginning of period (in shares) | 23,125 | |
Restricted stock units granted (in shares) | 74,100 | |
Restricted stock units vested (in shares) | (36,010) | |
Restricted units forfeited (in shares) | 0 | |
Outstanding at end of period (in shares) | 61,215 | 23,125 |
Unvested and expected to vest as of December 31, 2020 (in shares) | 61,215 | |
Weighted Average Grant Date Fair Value per Unit | ||
Outstanding at beginning of period (in dollars per share) | $ 23.83 | $ 16 |
Restricted stock units granted (in dollars per share) | 27.01 | $ 8.62 |
Restricted stock units vested (in dollars per share) | 25.34 | |
Restricted units forfeited (in dollars per share) | 0 | |
Vested and expected to vest, weighted average grant date fair value (in dollars per share) | $ 23.83 | |
Weighted Average Remaining Contractual Term (Years) | ||
Weighted Average Remaining Contractual Term (Years) | 1 year 4 months 24 days | 2 years 9 months 18 days |
Vested and expected to vest, weighted average remaining contractual term (in years) | 1 year 4 months 24 days | |
Shave-Based Compensation Arrangement By share-Based Payment Award, Equity Instruments Other Than Options, Aggregate Intrinsic Value [Roll Forward] | ||
Restricted stock units outstanding, aggregate intrinsic value, beginning of period | $ 565 | |
Restricted stock units granted, aggregate intrinsic value | 2,001 | |
Restricted stock units vested, aggregate intrinsic value | 811 | |
Restricted stock units outstanding, aggregate intrinsic value, end of period | 1,152 | $ 565 |
Vested and expected to vest, aggregate intrinsic value | $ 1,152 |
Equity Incentive Plans - Stock
Equity Incentive Plans - Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 6,973 | $ 3,266 |
Stock-based compensation expense | 6,973 | 3,266 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 966 | 579 |
Selling, general and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 6,007 | $ 2,687 |
Equity Incentive Plans - Fair V
Equity Incentive Plans - Fair Value Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, minimum | 82.00% | 69.00% |
Expected volatility, maximum | 118.00% | 84.00% |
Risk-free interest rate, minimum | 0.36% | 1.48% |
Risk-free interest rate, maximum | 1.40% | 2.38% |
Dividend yield | 0.00% | 0.00% |
Expected term | 6 years 29 days | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 5 years 14 days | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 years 29 days |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | ||||||||||
Net loss | $ (22,232) | $ (16,305) | $ (15,464) | $ (16,519) | $ (19,724) | $ (11,497) | $ (10,730) | $ (3,760) | $ (70,520) | $ (45,711) |
Denominator: | ||||||||||
Weighted-average shares outstanding, basic and diluted | 25,869,601 | 25,797,282 | 23,442,530 | 21,367,532 | 13,993,730 | 1,419,064 | 1,412,354 | 1,411,966 | 24,128,603 | 4,585,146 |
Net loss per share, basic and diluted | $ (2.92) | $ (9.97) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share | 3,546,926 | 2,801,025 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share | 3,485,711 | 2,777,900 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share | 61,215 | 23,125 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Feb. 28, 2021 | Apr. 30, 2019 | |
Lessee, Lease, Description [Line Items] | ||||
Future minimum lease payments | $ 650 | |||
Lease payments due over the life of the lease | 687 | |||
Rent expense | $ 400 | $ 200 | ||
Discount rate on finance lease | 3.00% | |||
Minimum | ||||
Lessee, Lease, Description [Line Items] | ||||
Remaining lease terms on finance leases | 1 year 8 months 12 days | |||
Maximum | ||||
Lessee, Lease, Description [Line Items] | ||||
Remaining lease terms on finance leases | 2 years 3 months 18 days | |||
Princeton New Jersey Office Space, Lease Ending in 2022 | ||||
Lessee, Lease, Description [Line Items] | ||||
Term of operating lease contracts | 3 years | |||
Future minimum lease payments | $ 700 | |||
Lease payments due over the life of the lease | $ 1,200 | |||
Remaining lease terms on operating leases | 1 year 7 months 6 days | |||
Lease Amendment | Subsequent Event | ||||
Lessee, Lease, Description [Line Items] | ||||
Future minimum operating lease payments due under amended lease agreement | $ 400 |
Leases - Balance Sheet Informat
Leases - Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Operating lease right-of-use asset | $ 644 | $ 783 |
Finance lease right-of-use asset | 34 | 14 |
Total right-of-use asset | 678 | 797 |
Operating lease liabilities | 400 | 290 |
Finance lease liabilities | 18 | 6 |
Total lease liabilities | 418 | 296 |
Operating lease liabilities, non-current | 250 | 500 |
Finance lease liabilities, non-current | 19 | 12 |
Total lease liabilities, non-current | $ 269 | $ 512 |
Leases - Lease Maturity Schedul
Leases - Lease Maturity Schedules (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Finance Lease Liability [Abstract] | ||
2021 | $ 18 | |
2022 | 16 | |
2023 | 4 | |
Total undiscounted cash flows | 38 | |
Less: imputed interest | (1) | |
Total lease liability | 37 | |
Less: current portion | (18) | $ (6) |
Lease liability | 19 | 12 |
Operating Lease, Liability [Abstract] | ||
2021 | 432 | |
2022 | 255 | |
2023 | 0 | |
Total undiscounted cash flows | 687 | |
Less: imputed interest | (37) | |
Future minimum lease payments | 650 | |
Less: current portion | (400) | (290) |
Lease liability | 250 | 500 |
Lessee Disclosure [Abstract] | ||
2021 | 450 | 319 |
2022 | 271 | 316 |
2023 | 4 | 186 |
Total undiscounted cash flows | 725 | 821 |
Less: imputed interest | (38) | (13) |
Total lease liability | 687 | 808 |
Less: current portion | (418) | (296) |
Total lease liabilities, non-current | $ 269 | $ 512 |
Commitment and Contingencies (D
Commitment and Contingencies (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Licensing Agreements | |
Long-term Purchase Commitment [Line Items] | |
Upfront payment for non-exclusive license agreement | $ 5 |
Income Taxes - Income Tax Recon
Income Taxes - Income Tax Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
State taxes (tax effected) | 7.70% | 8.50% |
Research tax credit | 1.70% | 3.30% |
Other permanent differences | 0.30% | (2.00%) |
Change in valuation allowance | (30.70%) | (30.80%) |
Provision for income taxes | 0.00% | 0.00% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 29,786 | $ 12,454 |
Credits | 3,836 | 2,408 |
Tangible and intangible assets | 2,666 | 1,977 |
Lease liability | 195 | 227 |
Stock compensation | 1,737 | 253 |
Accruals and Reserves | 840 | 36 |
Gross deferred tax assets | 39,060 | 17,355 |
Less: Valuation allowance | (38,051) | (16,423) |
Deferred tax assets, net of valuation allowance | 1,009 | 932 |
Deferred tax liabilities: | ||
Prepaids | (817) | (708) |
Right of use asset | (192) | (224) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Tax Credit Carryforward [Line Items] | ||
Income tax provision or benefit | $ 0 | $ 0 |
Provision for income taxes | 0.00% | 0.00% |
Increase in valuation allowance | $ 21,600,000 | $ 10,700,000 |
Net operating loss carryforwards | 120,600,000 | 59,100,000 |
Net operating loss carryforwards subject to expiration | 116,100,000 | 54,600,000 |
State and Local Jurisdiction | ||
Tax Credit Carryforward [Line Items] | ||
Net operating loss carryforwards | 123,900,000 | 60,700,000 |
Research and experimentation credit carryforward | 700,000 | 400,000 |
Domestic Tax Authority | ||
Tax Credit Carryforward [Line Items] | ||
Research and experimentation credit carryforward | $ 3,300,000 | $ 2,100,000 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at the beginning of the year | $ 5,388 | $ 1,989 |
Increases for tax positions taken during prior period | 50 | 0 |
Increases for tax positions taken during current period | 0 | 3,399 |
Balance at the end of the year | $ 5,438 | $ 5,388 |
Quarterly Results of Operations
Quarterly Results of Operations Data (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Condensed Financial Information Disclosure [Abstract] | ||||||||||
Research and development | $ 11,707 | $ 8,210 | $ 8,554 | $ 11,340 | $ 15,034 | $ 8,088 | $ 8,101 | $ 2,405 | $ 39,811 | $ 33,628 |
Selling, general and administrative | 10,537 | 8,112 | 6,940 | 5,589 | 5,127 | 3,809 | 3,132 | 1,605 | 31,178 | 13,673 |
Total operating expenses | 22,244 | 16,322 | 15,494 | 16,929 | 20,161 | 11,897 | 11,233 | 4,010 | 70,989 | 47,301 |
Operating Income (Loss) | (22,244) | (16,322) | (15,494) | (16,929) | (20,161) | (11,897) | (11,233) | (4,010) | (70,989) | (47,301) |
Other income, net | 12 | 17 | 30 | 410 | 437 | 400 | 503 | 250 | 469 | 1,590 |
Net loss and comprehensive loss | $ (22,232) | $ (16,305) | $ (15,464) | $ (16,519) | $ (19,724) | $ (11,497) | $ (10,730) | $ (3,760) | $ (70,520) | $ (45,711) |
Income (Loss) from Continuing Operations, Per Basic and Diluted Share (in dollars per share) | $ (0.86) | $ (0.63) | $ (0.66) | $ (0.77) | $ (1.41) | $ (8.10) | $ (7.60) | $ (2.66) | ||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted (in shares) | 25,869,601 | 25,797,282 | 23,442,530 | 21,367,532 | 13,993,730 | 1,419,064 | 1,412,354 | 1,411,966 | 24,128,603 | 4,585,146 |