Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 25, 2020 | Oct. 03, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | VIELA BIO, INC. | ||
Entity Central Index Key | 0001734517 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 379.7 | ||
Entity Common Stock, Shares Outstanding | 50,990,750 | ||
Entity Shell Company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Title of 12(b) Security | Common Stock, $0.001 par value per share | ||
Trading Symbol | VIE | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-39067 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 82-4187338 | ||
Entity Address, Address Line One | One MedImmune Way | ||
Entity Address, Address Line Two | First Floor, Area Two | ||
Entity Address, City or Town | Gaithersburg | ||
Entity Address, State or Province | MD | ||
Entity Address, Postal Zip Code | 20878 | ||
City Area Code | 240 | ||
Local Phone Number | 558-0038 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | None. |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 200,851 | $ 126,898 |
Marketable securities | 113,945 | |
Receivable from stockholders | 12,000 | |
Accounts receivable | 30,000 | |
Prepaid and other current assets | 6,242 | 456 |
Total current assets | 351,038 | 139,354 |
Marketable securities, non-current | 31,415 | |
Property and equipment, net | 1,499 | 473 |
Other assets | 102 | |
Total assets | 384,054 | 139,827 |
Current liabilities: | ||
Accounts payable | 7,459 | 1,142 |
Accrued expenses and other current liabilities | 9,192 | 2,769 |
Related party liability | 12,892 | 12,054 |
Total current liabilities | 29,543 | 15,965 |
Commitments and contingencies (Note 12) | ||
Redeemable convertible preferred stock (Series A-1, A-2 and A-3), $.001 par value; no shares authorized, issued and outstanding as of December 31, 2019, and 37,695,912 shares authorized, and 31,225,324 shares issued and outstanding as of December 31, 2018 | 312,253 | |
Stockholders’ equity (deficit): | ||
Preferred stock, $0.001 par value; 5,000,000 shares and no shares authorized as of December 31, 2019 and 2018, respectively; no shares issued or outstanding as of December 31, 2019 and 2018 | ||
Common stock, $.001 par value; 200,000,000 and 41,254,509 shares authorized as of December 31, 2019 and 2018, respectively; 50,617,868 and 10 shares issued and outstanding as of December 31, 2019 and 2018, respectively | 51 | |
Additional paid-in capital | 631,154 | 1,879 |
Accumulated other comprehensive income | 5 | |
Accumulated deficit | (276,699) | (190,270) |
Total stockholders’ equity (deficit) | 354,511 | (188,391) |
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | $ 384,054 | 139,827 |
Redeemable Convertible Preferred Stock (Series A-1, A-2 and A-3) | ||
Current liabilities: | ||
Redeemable convertible preferred stock (Series A-1, A-2 and A-3), $.001 par value; no shares authorized, issued and outstanding as of December 31, 2019, and 37,695,912 shares authorized, and 31,225,324 shares issued and outstanding as of December 31, 2018 | $ 312,253 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Redeemable convertible preferred stock, shares authorized | 37,695,912 | |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 0 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 41,254,509 |
Common stock, shares issued | 50,617,868 | 10 |
Common stock, shares outstanding | 50,617,868 | 10 |
Redeemable Convertible Preferred Stock (Series A-1, A-2 and A-3) | ||
Redeemable convertible preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Redeemable convertible preferred stock, shares authorized | 0 | 37,695,912 |
Redeemable convertible preferred stock, shares issued | 0 | 31,225,324 |
Redeemable convertible preferred stock, shares outstanding | 0 | 31,225,324 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue: | ||
Total revenue | $ 50,000 | |
Revenue from Contract with Customer, Product and Service [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | ||
Research and development | $ 104,641 | $ 42,414 |
General and administrative | 35,050 | 6,565 |
Acquisition of in-process research and development | 143,333 | |
Total operating expenses | 139,691 | 192,312 |
Loss from operations | (89,691) | (192,312) |
Other income: | ||
Interest income | 3,262 | 2,042 |
Total other income | 3,262 | 2,042 |
Net loss | $ (86,429) | $ (190,270) |
Net loss per share attributable to common stockholders—basic and diluted | $ (7.02) | $ (19,027,000) |
Weighted average common shares outstanding—basic and diluted | 12,309,231 | 10 |
Other comprehensive income | ||
Unrealized gains (losses) on marketable securities, net | $ 5 | |
Total other comprehensive income | 5 | |
Total comprehensive loss | $ (86,424) | $ (190,270) |
STATEMENTS OF REDEEMABLE CONVER
STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Redeemable Convertible Preferred Stock |
Beginning Balances, Shares at Dec. 31, 2017 | 10 | |||||
Stock-based compensation expense | $ 1,879 | $ 1,879 | ||||
Issuance of preferred stock | $ 312,253 | |||||
Issuance of preferred stock, Shares | 31,225,324 | |||||
Net loss | (190,270) | $ (190,270) | ||||
Redeemable convertible preferred stock, Ending Balance, Shares at Dec. 31, 2018 | 31,225,324 | |||||
Redeemable convertible preferred stock, Ending Balance at Dec. 31, 2018 | 312,253 | $ 312,253 | ||||
Ending Balances, Shares at Dec. 31, 2018 | 10 | |||||
Ending Balances at Dec. 31, 2018 | (188,391) | 1,879 | (190,270) | |||
Stock-based compensation expense | 3,625 | 3,625 | ||||
Issuance of common stock for stock options exercised | $ 1,521 | $ 1 | 1,520 | |||
Issuance of common stock for stock options exercised shares | 535,363 | 535,363 | ||||
Issuance of common stock upon vesting of RSAs, Shares | 378,789 | |||||
Issuance of preferred stock | $ 155,000 | |||||
Issuance of preferred stock, Shares | 9,393,382 | |||||
Issuance of common stock in connection with the initial public offering, net of underwriting discounts, commissions and offering costs | $ 156,927 | $ 9 | 156,918 | |||
Issuance of common stock in connection with the initial public offering, net of underwriting discounts, commissions and offering costs, Shares | 9,085,000 | |||||
Redeemable convertible preferred stock, Conversion of preferred stock into common stock | $ (467,253) | |||||
Redeemable convertible preferred stock, Conversion of preferred stock into common stock, Shares | (40,618,706) | |||||
Conversion of preferred stock into common stock, Shares | 40,618,706 | |||||
Conversion of preferred stock into common stock | 467,253 | $ 41 | 467,212 | |||
Unrealized gains (losses) on marketable securities | 5 | $ 5 | ||||
Net loss | (86,429) | (86,429) | ||||
Ending Balances, Shares at Dec. 31, 2019 | 50,617,868 | |||||
Ending Balances at Dec. 31, 2019 | $ 354,511 | $ 51 | $ 631,154 | $ 5 | $ (276,699) |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (86,429) | $ (190,270) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 184 | 18 |
Stock-based compensation expense | 3,625 | 1,879 |
Acquisition of in-process research and development | 143,333 | |
Amortization of premiums (discounts) on marketable securities, net | (10) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (30,000) | |
Prepaid and other assets | (5,888) | (456) |
Accounts payable, accrued expenses and related party liability | 13,469 | 15,965 |
Net cash used in operating activities | (105,049) | (29,531) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (161,036) | |
Sales and maturities of marketable securities | 15,691 | |
Purchase of property and equipment | (1,101) | (491) |
Acquisition of in-process research and development | (143,333) | |
Net cash used in investing activities | (146,446) | (143,824) |
Cash flows from financing activities: | ||
Proceeds from initial public offering | 172,615 | |
Proceeds from exercise of common stock options | 1,521 | |
Proceeds from issuance of redeemable convertible preferred stock | 167,000 | 300,253 |
Payment of initial public offering costs | (15,688) | |
Net cash provided by financing activities | 325,448 | 300,253 |
Net increase in cash and cash equivalents | 73,953 | 126,898 |
Cash and cash equivalents at beginning of period | 126,898 | |
Cash and cash equivalents at end of year | 200,851 | 126,898 |
Supplemental disclosure of non-cash financing and investing activities: | ||
Receivable from sale of preferred stock | $ 12,000 | |
Conversion of convertible redeemable preferred stock into common stock | 467,253 | |
Purchases of property and equipment included in accounts payable | $ 109 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of the Business and Basis of Presentation | 1. Nature of the business and basis of presentation Viela Bio, Inc. (“Viela” or the “Company”) is a clinical-stage biotechnology research and development company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease. The Company was incorporated on December 11, 2017 under the laws of the State of Delaware. From December 11, 2017 to December 31, 2017 the Company had no substantive operations. In February 2018, pursuant to an Asset Purchase Agreement (the “Asset Purchase Agreement”) with MedImmune, LLC, MedImmune Limited (collectively, “MedImmune”), and AstraZeneca Collaboration Ventures, LLC (“AZ”, and, together with MedImmune, the “AZ Parties”), the Company acquired intellectual property and the biological, regulatory and other materials associated with a portfolio of clinical and pre-clinical molecules, for a purchase price of approximately $142,253 financed by AZ’s purchase of the Company’s Series A preferred stock. Following the asset purchase, the Company entered into several agreements with AZ and MedImmune, including a license agreement, sublicense agreements, a transition services agreement, a clinical supply agreement and a commercial supply agreement. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, ability to secure additional capital to fund operations, completion and success of clinical testing, compliance with applicable governmental regulations, development by competitors of new technological innovations, dependence on key personnel and protection of proprietary technology. Drug candidates currently under development will require extensive clinical testing prior to regulatory approval and commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. In October, 2019, the Company completed an initial public offering (the “IPO”) of its common stock and issued and sold 7,900,000 shares of common stock at a public offering price of $19.00 per share, resulting in gross proceeds of $150,100 and net proceeds of $135,988 after deducting underwriting discounts and commissions and offering expenses of approximately $14,112. In addition, and contemporaneously with the closing of the issuance and sale of the aforementioned shares, the Company issued and sold an additional 1,185,000 shares of common stock, pursuant to the full exercise of the underwriter’s option to purchase additional shares, for gross proceeds of $22,515 and net proceeds of $20,939 after deducting underwriting discounts and commissions of $1,576. Thus, the aggregate gross proceeds to the Company from the IPO were $172,615 and net proceeds after deducting underwriting discounts and commissions and other offering costs, were $156,927. Upon the closing of the IPO, the outstanding shares of series A redeemable convertible preferred stock (the “Series A Preferred Stock”), and series B redeemable convertible preferred stock (the “Series B Preferred Stock” and together with the Series A Preferred Stock, the “Preferred Stock”) converted into an aggregate of 40,618,706 shares of common stock. Upon conversion of the Preferred Stock, the Company reclassified the carrying value of the redeemable convertible preferred stock to common stock and additional paid-in capital. Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). All adjustments necessary for the fair presentation of the Company’s financial statements have been presented. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of significant accounting policies Use of estimates The preparation of the Company’s financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the recognition of research and development expenses based on when services are performed, the valuations of share based compensation arrangements, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. Cash and cash equivalents Cash equivalents represent highly liquid instruments with an original maturity of 90 days or less at acquisition. Cash and cash equivalents include investments in money market funds with commercial banks and financial institutions, and commercial paper of high-quality corporate issuers. Marketable Securities The Company’s marketable securities, consisting of debt securities, are classified as available-for-sale and are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholder’s equity (deficit). Realized gains and losses and declines in value determined to be other than temporary are based on the specific identification method and are included as a component of other income (expense), net in the statements of operations and comprehensive loss. Marketable securities that mature within one year from the balance sheet date are classified as current. The Company evaluates its marketable securities with unrealized losses for other-than-temporary impairment. When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustments to fair value reflects a decline in the value of the investment that the Company considers to be “other-than-temporary”, the Company reduces the investment to fair value through a charge to the statements of operations and comprehensive loss. No such adjustments were necessary during the periods presented. Concentrations of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and the Company’s money market fund investment. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Fair value measurements Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined 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. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying amount of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and accounts payable approximate their fair values. No transfer of assets between Level 1 and Level 2 of the fair value hierarchy occurred during the years ended December 31, 2019 and 2018. Segment information The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is developing and commercializing transformative treatments for severe inflammation and autoimmune diseases. Research and development expenses Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including personnel expenses, stock-based compensation expense, allocated facility-related and depreciation expenses, third-party license fees and external costs including fees paid to consultants and clinical research organizations (“CROs”), in connection with nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Costs incurred in purchasing technology or technology licenses are charged immediately to research and development expense if the technology has not reached technological feasibility and has no alternative future uses. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. A majority of these payments are pass-through payments that are made to AZ Parties due to the existing contracts in place associated with the in-process research and development (“IPR&D”) assets acquired (see Note 8, "Asset acquisition"). The Company, primarily through the AZ Parties outsources a substantial portion of its clinical trial activities, utilizing external entities such as CROs, independent clinical investigators, and other third-party service providers to assist it with the execution of its clinical studies. For each clinical trial that the Company conducts, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter the trial, and/or the period over which clinical investigators or CROs are expected to provide services. Clinical activities which relate principally to clinical sites and other administrative functions to manage the Company’s clinical trials are performed primarily by CROs. CROs typically perform most of the start-up activities for the Company’s trials, including document preparation, site identification, screening and preparation, pre-study visits, training, and program management. These start-up costs usually occur within a few months after the contract has been executed and are event-driven in nature. The remaining activities and related costs, such as patient monitoring and administration, generally occur ratably throughout the life of the individual contract or study. In the event of early termination of a clinical trial, the Company accrues and recognizes expenses in an amount based on its estimate of the remaining non-cancelable obligations associated with the winding down of the clinical trial and/or penalties. For clinical study sites, where payments are made periodically on a per-patient basis to the institutions performing the clinical study, the Company accrues expenses on an estimated cost-per-patient basis, based on subject enrollment and activity in each period. The amount of clinical study expense recognized may vary from period to period based on the duration and progress of the study, the activities to be performed by the sites each quarter, the required level of patient enrollment, the rate at which patients actually enroll in and drop out of the clinical study, and the number of sites involved in the study. Clinical trials that bear the greatest risk of change in estimates are typically those that have a significant number of sites, require a large number of patients, have complex patient screening requirements, and span multiple years. During the course of a trial, the Company adjusts its rate of clinical expense recognition if actual results differ from the Company’s estimates. The Company’s estimates and assumptions for clinical expense recognition could differ significantly from the Company’s actual results, which could cause material increases or decreases in research and development expenses in future periods when the actual results become known. Patent costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Property and equipment Property and equipment, which consists mainly of laboratory equipment, are carried at cost less accumulated depreciation. Depreciation expense is recognized using straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Machinery and equipment 5 years Furniture and fixtures 7 years Leasehold improvements Lesser of lease term or life of asset Expenditures for maintenance and repairs which do not materially extend the useful lives of the assets are charged to expense as incurred. The cost and accumulated depreciation or amortization of assets either retired or sold are removed from the respective accounts, and any gain or loss is recognized in operations. Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. The Company did not record any impairment losses on long-lived assets during the years ended December 31, 2019 and 2018. Revenue Recognition for Contracts with Customers To date, the Company has recognized revenues through commercialization and collaboration agreements. Effective January 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2014-09, Revenue (ASC 606): Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. Under this method, results for reporting periods beginning on January 1, 2019 are presented under ASC 606, while prior periods were prepared and reported in accordance with ASC Topic 605, Revenue Recognition (“ASC 605”). The adoption of ASC 606 resulted in no cumulative adjustment as the Company had substantially no assets until executing the Asset Acquisition in February 2018 (as described in Note 8, "Asset acquisition") and did not enter into a revenue contract with a customer until May 2019 (as described in Note 14, "Collaboration agreements"). ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. We assess if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method. Amounts recognized as revenue for which the Company has the contractual right to bill, but has not yet received, are classified as accounts receivable in the accompanying balance sheets. Amounts recognized as revenue for which the Company does not have the contractual right to bill are generally recognized as contract assets in the accompanying balance sheets. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current liabilities in the accompanying balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as long-term liabilities. Licenses of Intellectual Property – The terms of the Company’s contracts with customers may include the license of functional intellectual property, given the functionality of the intellectual property is not expected to change substantially as a result of the Company’s ongoing activities. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the portion of the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises (that is, for licenses that are not distinct from other promised goods and services in an arrangement), the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments – If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. Royalties – For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue or milestone payments resulting from any of its licensing arrangements. Significant Financing Component – In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. Collaborative Arrangements – The Company enters into collaboration agreements, which are within the scope of ASC 606, to discover, develop, manufacture or commercialize product candidates. The terms of these agreements typically contain multiple promises or obligations, which may include: (1) licenses, or options to obtain licenses, to use the Company’s technology, (2) research and development activities to be performed on behalf of the collaboration partner, and (3) in certain cases, services in connection with the manufacturing of preclinical and clinical material. Payments the Company receives under these arrangements typically include one or more of the following: non-refundable, upfront license fees; clinical and development, regulatory, and sales milestone payments; and royalties on future product sales. The Company also analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 606. For those elements of the arrangement that are accounted for pursuant to ASC 606, the Company applies the five-step model described above. Stock-based compensation The Company measures all stock-based awards granted to employees based on the fair value on the date of the grant and recognizes compensation expense into either general and administrative expense or research and development expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The Company accounts for forfeitures as they occur. For stock-based awards with service-based vesting conditions, the Company recognizes compensation expense using the straight-line method. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option The Company classifies stock-based compensation expense in its statement of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. Common stock valuations Prior to the IPO, because there was no public market for our common stock as we were a private company, our board of directors determined the fair value of our common stock by considering a number of objective and subjective factors, including having contemporaneous and retrospective valuations of our equity performed by a third-party valuation specialist, valuations of comparable peer public companies, sales of our convertible preferred stock, operating and financial performance, the lack of liquidity of our common stock, and general and industry-specific economic outlook. Following our IPO, the closing sale price per share of our common stock as reported on The Nasdaq Global Select Market on the date of grant is used to determine the fair value exercise price per share of our share-based awards to purchase common stock. Income taxes The Company accounts for income taxes in accordance with ASC Topic 740, Income Taxes The Company recognizes the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2019 the Company had no unrecognized tax benefits and as such, no liability, interest or penalties were required to be recorded. The Company does not expect this to change significantly in the next twelve months. Net loss per share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Prior to the IPO, the Company followed the two-class method when computing net loss per share, which is an earnings allocation formula that determines net loss per share for the holders of the Company’s common shares and participating securities. The Company’s Preferred Stock contains participating rights in any dividend paid by the Company and are deemed to be participating securities. Net income attributable to common stockholders and participating preferred shares is allocated to each share on an as-converted basis as if all of the earnings for the period had been distributed. The participating securities do not include a contractual obligation to share in the losses of the Company and are not included in the calculation of net loss per share in the periods that have a net loss. Common equivalent shares are excluded from the computation in periods in which they have an anti-dilutive effect on net loss per share. Diluted net loss per share is computed using the more dilutive of (a) the two-class method or (b) the if-converted method. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Diluted net loss per share is equivalent to basic net loss per share for the periods presented herein because common stock equivalent shares from the Series A and Series B Preferred Stock were anti-dilutive. Due to their anti-dilutive effect, the calculation of diluted net loss per share for the year ended December 31, 2018 does not include 31,225,324 shares of Series A Preferred Stock. Subsequent to the IPO, basic net loss per common share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options. Accordingly, in periods in which the Company reported a net loss, dilutive common shares were not included in the calculation as their affect was anti-dilutive, and as a result, diluted net loss per common share was the same as basic net loss per common share for the year ended December 31, 2019. For the years ended December 31, 2019 and 2018, there were no reconciling items between basic and diluted net loss per share. Emerging growth company The Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. The Company has elected this exemption to delay adopting new or revised accounting standards until such time as those standards apply to private companies. Where allowable, the Company has early adopted certain standards as described below. Recently adopted accounting pronouncements In January 2017, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business In May 2017, the FASB issued ASU No. 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and ASC 606 (“ASU 2018-18”). The amendments in ASU 2018-18 make targeted improvements to GAAP for collaborative arrangements by clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in ASC 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. In addition, unit-of-account guidance in ASU 2018-18 was aligned with the guidance in ASC 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of ASC 606. The amendments should be applied retrospectively to the date of initial application of ASC 606. The Company adopted this guidance effective January 1, 2019 with its initial application of ASC 606. The adoption of the standard did not have an impact on the Company’s financial statements. Recently issued accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) For all other entities, the ASU is effective for annual periods beginning after December 15, 2020, . In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) (Part I) Accounting for Certain Financial Instruments with Down Round Features (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception In August 2018, the FASB issued No. ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 12 Months Ended |
Dec. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Cash, Cash Equivalents and Marketable Securities | 3. Cash, cash equivalents and marketable securities The following is a summary of the Company’s cash, cash equivalents and available-for-sale marketable securities by significant investment category: December 31, 2019 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Current Marketable Securities Non-Current Marketable Securities Cash $ 26,821 $ — $ — $ 26,821 $ 26,821 $ — $ — Level 1 Money market funds 157,777 — — 157,777 157,777 — — Subtotal 157,777 — — 157,777 157,777 — — Level 2 U.S. Treasury securities 9,623 7 — 9,630 — 4,805 4,825 Commercial paper 55,021 4 (9 ) 55,016 13,050 41,966 — Corporate debt securities 96,964 28 (25 ) 96,967 3,203 67,174 26,590 Subtotal 161,608 39 (34 ) 161,613 16,253 113,945 31,415 Total $ 346,206 $ 39 $ (34 ) $ 346,211 $ 200,851 $ 113,945 $ 31,415 December 31, 2018 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Current Marketable Securities Non-Current Marketable Securities Cash $ 21,681 $ — $ — $ 21,681 $ 21,681 $ — $ — Level 1 Money market funds 105,217 — — 105,217 105,217 — — Total $ 126,898 $ — $ — $ 126,898 $ 126,898 $ — $ — The maturities of the Company’s long-term marketable securities ranges from one to two years. The Company did not hold any available-for-sale marketable securities as of December 31, 2018. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment The following is a summary of the Company’s property and equipment, at cost: December 31, 2019 2018 Machinery and equipment $ 930 $ 491 Furniture and fixtures 359 — Leasehold improvements 412 — Total 1,701 491 Accumulated depreciation and amortization (202 ) (18 ) Total, net $ 1,499 $ 473 |
Accrued Liabilities and Other C
Accrued Liabilities and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities and Other Current Liabilities | 5. Accrued liabilities and other current liabilities The following is a summary of the Company’s accrued liabilities and other current liabilities as of December 31, 2019 and 2018: As of December 31, 2019 2018 Compensation and employee benefits $ 4,684 $ 2,224 Research and development expenses 2,693 61 Consulting and other professional fees 1,475 439 Other 340 45 Total $ 9,192 $ 2,769 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Common Stock | 6. Common stock Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders, provided, however, that except as otherwise required by law, holders of common stock shall not be entitled to vote on any amendment to the Company’s certificate of incorporation that relates solely to the terms of one or more outstanding series of preferred stock, if the holders of the affected series are entitled to vote thereon. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to the preferential dividend rights of preferred stock. |
Convertible Redeemable Preferre
Convertible Redeemable Preferred Stock | 12 Months Ended |
Dec. 31, 2019 | |
Temporary Equity [Abstract] | |
Convertible Redeemable Preferred Stock | 7. Convertible redeemable preferred stock The Preferred Stock converted into an aggregate of 40,618,706 shares of common stock upon the closing of the IPO in October 2019. At December 31, 2018, the Company’s redeemable convertible preferred stock consisted of the following: Preferred Stock Authorized Preferred Stock Issued and Outstanding Carrying Value Series A-1 Preferred Stock 14,225,324 14,225,324 $ 142,253 Series A-2 Preferred Stock 17,000,000 17,000,000 170,000 Series A-3 Preferred Stock 6,470,588 — — Total 37,695,912 31,225,324 $ 312,253 Series A Preferred Stock On February 23, 2018 (the “Transaction Date”), pursuant to the Series A Preferred Stock Purchase Agreement, by and among the Company and certain purchasers, and as part of an initial tranche closing, the Company issued 14,225,324 shares of Series A-1 preferred stock and 14,000,000 shares of Series A-2 preferred stock, par value $0.001 per share, at a purchase price of $10.00 per share, resulting in gross proceeds of approximately $282,253 to the Company (the “Initial Tranche Closing”). In addition to the Initial Tranche Closing, the Series A Preferred Stock Purchase Agreement provided for the issuance of up to 6,470,588 shares of Series A-3 at a purchase price of $17.00 per share upon acceptance for review by the U.S. FDA of the Company’s first biologics license application for lead product candidate, inebilizumab, for the indication neuromyelitis optica spectrum disorder (the “Milestone Closing”). However, at any time prior to the Milestone Closing, the board of directors could determine that the Company required additional capital to fund its operations, upon which the board of directors may cause the Company to sell and the holders of the Series A-2 to purchase up to 3,000,000 additional shares of Series A-2 preferred stock at a purchase price of $10.00 per share (the “Additional Closing”). In December 2018, the Additional Closing occurred, and the Company received $30,000 in exchange for 3,000,000 shares of Series A-2. As of December 31, 2018, $12,000 of the $30,000 was recorded as a receivable as funds were not received until January 2019 and the Company provided supplemental non-cash financing disclosure on its statement of cash flows for the year ended December 31, 2018. The proceeds received upon the Additional Closing would reduce the proceeds from the Milestone Closing. Both the Additional Closing and Milestone Closing were evaluated and determined to be embedded features within the Series A Preferred Stock that did not require bifurcation. In addition, if any holder of Series A-2 preferred stock failed to purchase the committed amount under either the Additional Closing or Milestone Closing (“Purchaser Default”), then all shares of Series A-2 preferred stock held by such holder would automatically be converted into shares of Common Stock as is determined by dividing (i) the aggregate number of shares of Series A-2 preferred stock held by such individual by (ii) 10 and (b) if such individual had previously converted their Series A-2 shares to Common Stock, 90% of such shares would automatically be redeemed by the Company for no consideration (the “Special Mandatory Redemption”). The Special Mandatory Redemption was evaluated and determined to be accounted for as an embedded derivative. However, the Company determined an insignificant value should be ascribed to the Special Mandatory Redemption as the likelihood of a Purchaser Default occurring was deemed to be remote both at the Transaction Date and December 31, 2018. In September 2019, the Company issued an aggregate of 4,705,882 shares of preferred stock at a purchase price of $17.00 per share for an aggregate gross consideration of $80,000. Series B Preferred Stock In June 2019, pursuant to the Series B Preferred Stock Purchase Agreement, by and among the Company and certain purchasers, the Company issued 4,687,500 shares of Series B Preferred Stock at a purchase price of $16.00 per share, resulting in gross proceeds of approximately $75,000 to the Company. Prior to the closing of the IPO, the holders of the Preferred Stock had the following rights and preferences: Voting Each holder of the Preferred Stock was entitled to the number of votes equal to the number of shares of Common Stock into which the number of shares of Preferred Stock held by such holder were convertible and should vote together with the holders of Common Stock as a single class. The holders of the preferred stock were entitled to elect seven of the eight directors on the Board of Directors. Two of the seven directors were elected by the Series A-1 preferred stockholders, four of the directors were elected by the Series A-2 preferred stockholders, one of the directors was elected by the Series B preferred stockholders, and the remaining director is the Company’s chief executive officer. Dividends The Series B preferred stock accrued cumulative dividends on a daily basis at a fixed dividend rate of $1.28 per share per annum payable only when, as and if declared by the Board of Directors of the Company, prior and in preference to any declaration or payment of any dividend on shares of any other class or series of capital stock of the Company (“Accruing Dividends”) unless the holders of the Series B preferred stock first (and Series A preferred stock thereafter) received, or simultaneously received, a dividend in an amount at least equal to the formula included in the Company’s charter which varied based on whether the dividend was on the Common Stock or on any other class or series not convertible into Common Stock. Through October 3, 2019, no dividends had been declared or paid by the Company. Liquidation In the event of any liquidation, dissolution or winding-up of the Company or a Deemed Liquidation Event (as defined below), the holders of the Series B preferred stock then outstanding would be entitled to be paid out of the assets of the Company available for distribution to stockholders, and before any payment would be made to holders of Series A preferred stock and Common Stock, in an amount per share equal to the original issue price per share, plus all Accruing Dividends accrued but unpaid thereon, whether or not declared, together with all other declared but unpaid dividends thereon. If upon such event, the assets of the Company available for distribution were insufficient to permit payment in full to the holders of Series B preferred stock, the proceeds would be ratably distributed among the holders of Series B preferred stock. After satisfaction of the Series B preferred stock liquidation preference, the holders of the Series A preferred stock were entitled to be paid before any payment shall be made to the holders of Common Stock in an amount equal to the original issue price per share, plus any declared but unpaid dividends thereon. Due to this redemption option, the Preferred Stock was recorded in mezzanine equity and subject to subsequent measurement under the guidance provided under ASC 480-10-S99. In accordance with that guidance, the Company had elected to not recognize any subsequent changes in the redemption value as the Company has determined it was not probable that the Preferred Stock would become redeemable. After payments have been made in full to the holders of the Preferred Stock, the remaining assets of the Company available for distribution would be distributed among the holders of Preferred Stock and the holders of Common Stock on a pro-rata basis as if the shares of Preferred Stock were converted into Common Stock immediately prior to the liquidation event. A merger or consolidation involving the Company in which the stockholders of the Company do not own a majority of the outstanding shares of the surviving company shall be considered a Deemed Liquidation Event. A sale, lease, transfer, exclusive license or other disposition of all or substantially all of the assets of the Company shall also be considered a Deemed Liquidation Event. As of December 31, 2018, the liquidation preference of the outstanding shares of the Preferred Stock was approximately $312,253. Conversion Each share of Preferred Stock was convertible into Common Stock at the option of the holder at any time after the date of issuance. In addition, each share of Preferred Stock would be automatically converted into shares of Common Stock, at the applicable conversion ratio then in effect, upon the earlier of (i) a qualified public offering with net proceeds of at least $75,000 and a price of not less than $17.60 per share, subject to appropriate adjustment for any stock dividend, stock split, combination or other similar recapitalization, (ii) by the affirmative vote of the holders of at least 75% of the then-outstanding Series A preferred stock and a majority of the holders of the outstanding shares of the Series B preferred stock, if such vote was obtained prior to the Milestone Closing or (iii) by the affirmative vote of the holders of at least 75% of the then-outstanding shares of Series A-2 preferred stock and Series A-3 preferred stock (voting together as a single class on an as-converted to Common Stock basis) and a majority of the outstanding shares of Series B preferred stock (voting together as a single class on an as-converted to Common Stock basis) if such vote was obtained after the Milestone Closing. Upon conversion, the shares of Preferred Stock would be converted into Common Stock, at par value, with the remainder recorded to additional paid-in capital. The conversion ratio of the Preferred Stock was determined by dividing the original issue price per share by the conversion price in effect at the time of conversion. The initial conversion price was equal to the original issuance price of the Preferred Stock and was subject to appropriate adjustment in the event of any stock dividend, stock split, combination or recapitalization affecting the Preferred Stock. Upon the closing of the IPO, the Company’s outstanding Preferred Stock converted into an aggregate of 40,618,706 shares of common stock. Upon conversion of the Preferred Stock, the Company reclassified the carrying value of the Preferred Stock to common stock and additional paid-in capital. |
Asset Acquisition
Asset Acquisition | 12 Months Ended |
Dec. 31, 2019 | |
Asset Acquisition [Abstract] | |
Asset Acquisition | 8. Asset acquisition Contemporaneously on the Transaction Date, the Company entered into the Asset Purchase Agreement with the AZ Parties to acquire the intellectual property and the biological, regulatory and other materials associated with a portfolio of clinical molecules (“Clinical Molecules”) and pre-clinical molecules for potential therapies for autoimmune diseases and inflammation (collectively, the “Acquired Molecules”), for a purchase price of approximately $142,253 (“Asset Acquisition”), which includes direct and incremental transaction expenses of approximately $1,000. The Acquired Molecules consist of multiple in-process research and development projects related to biological therapies which are intended to treat an interrelated subset of auto-immune disorders, represented in part by common biological characteristics. As of the acquisition date, the Acquired Molecules were either in the pre-clinical stage, Phase 1a trial, Phase 1b trial or Phase 2 trial. Further, the Acquired Molecules are related to various potential indications, all of which were identified by the Company as preliminary on the Transaction Date. Until a lead indication is identified, it is not uncommon for the preliminary indications of a drug compound to change during the early clinical development stages. In addition to the Acquired Molecules, in connection with the Asset Acquisition certain former employees of the AZ Parties were either hired by the Company simultaneously or shortly following the Transaction Date. Further, the Company assumed certain ongoing CRO contracts from the AZ Parties related to the research and development of the Acquired Molecules. The services provided by the CRO contracts are readily available in the marketplace and are not considered to be unique or scarce. The estimated fair value associated with the employees and CRO contracts was deemed to be insignificant. The Asset Acquisition was accounted for as acquisition of assets that did not meet the definition of a business. The Asset Acquisition did not constitute a business as substantially all of the fair value of the gross assets acquired was concentrated in the Clinical Molecules, which represent a group of similar identifiable assets as of the acquisition date. As of the acquisition date, the Clinical Molecules were deemed to share similar risk characteristics as (1) each of the Clinical Molecules were in the early development stages of a drug compound and shared a similar financial, technical and regulatory risk profile, (2) only preliminary indications had been identified for any of the Clinical Molecules and (3) the underlying biologic therapies of the Clinical Molecules were similar in that each was intended to treat an interrelated subset of autoimmune disorders by interrupting biologic mechanisms that otherwise result in inflammation and tissue damage. Because the Acquired Molecules were accounted for as an asset acquisition that did not meet the definition of a business, the Acquired Molecules were recorded at their fair values, which equaled the fair value of the consideration paid of approximately $142,253. However, because the Acquired Molecules represent in-process research and development with no alternative future use, the Company immediately expensed the fair value of the Acquired Molecules in the Statement of Operations and Comprehensive Loss. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | 9. Stock-based compensation The Company’s Amended and Restated 2018 Equity Incentive Plan (the “Equity Incentive Plan”) provides for the grant of stock options (both incentive and non-statutory), restricted stock awards, restricted stock unit awards, stock appreciation rights, and other forms of stock-based awards to employees, consultants and directors. During the years ended December 31, 2019 and 2018, the Company granted stock options that vest over four years and have a maximum contractual term of ten years. The Company also granted restricted stock awards that vest over two years during the year ended December 31, 2018. Vesting is subject to the holder’s continuous service with the Company. The Company reserved 5,541,224 shares of common stock for issuance under the Equity Incentive Plan. Stock option valuation The fair value of each stock option grant was estimated using the Black-Scholes option-pricing model as of the date of grant. The fair value of the Company’s option awards granted during the years ended December 31, 2019 and 2018, was estimated using the following assumptions: Year Ended December 31, 2019 2018 Risk-free rate of interest 1.45 - 2.52% 2.87 % Expected term (years) 5.50 - 6.24 6.00 Expected stock price volatility 62.50 - 84.61% 83.30 % Dividend yield 0.00 % 0.00 % Weighted average fair value of common stock $ 13.75 $ 2.84 Stock options The following table summarizes the Company’s stock option activity for the year ended December 31, 2019: Number of options Weighted- average exercise price Weighted- average remaining contractual term (years) Outstanding at December 31, 2018 2,485,650 2.84 9.25 Granted 1,460,520 13.75 Exercised (535,363 ) 2.84 Cancelled (123,550 ) 3.96 Outstanding at December 31, 2019 3,287,257 7.65 8.82 Exercisable at December 31, 2019 500,647 2.86 8.20 Vested and expected to vest at December 31, 2019 3,287,257 7.65 8.82 No options were vested or exercisable as of December 31, 2018. The weighted average grant date fair value per share of options granted during the years ended December 31, 2019 and 2018 was $9.25 and $1.99, respectively. The aggregate intrinsic value of options exercised as of December 31, 2019 was approximately $2,100. The aggregate intrinsic value of options vested and expected to vest as of December 31, 2019 was approximately $64,116. The aggregate intrinsic value of options vested and exercisable as of December 31, 2019 was approximately $12,158. As of December 31, 2019, there was approximately $14,708 total unrecognized compensation expense, related to the unvested stock options, which is expected to be recognized over a weighted average period of 3.28 years. Restricted common stock The following table summarizes the information about restricted stock awards (“RSA”) outstanding for the year ended December 31, 2019: Number of shares Grant-date fair value Unvested as of December 31, 2018 757,577 $ 2.84 Granted — — Vested/Released (378,789 ) 2.84 Cancelled (6,631 ) 2.84 Unvested as of December 31, 2019 372,157 $ 2.84 The restricted stock vests 50% on each anniversary date of the grant, over a two-year period. Vesting is subject to the holder’s continuous service with the Company. As of December 31, 2019, there was approximately $197 of total unrecognized compensation expense, related to the restricted stock grants, which is expected to be recognized over a weighted average period of 0.25 years. Stock-based compensation Stock-based compensation expense for the years ended December 31, 2019 and 2018 was comprised of the following: Year Ended December 31, 2019 2018 Research and development $ 1,820 $ 935 General and administrative 1,805 944 Total stock-based compensation expense $ 3,625 $ 1,879 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income taxes During the years ended December 31, 2019 and 2018, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period due to its uncertainty of realizing a benefit from those items. All of the Company’s operating losses since inception have been generated in the United States. A summary of the Company’s current and deferred tax provision is as follows: December 31, 2019 December 31, 2018 Current income tax provision: Federal $ — $ — State — — Total current income tax provision — — Deferred income tax benefit: Federal (25,926 ) (44,529 ) State (5,807 ) (12,350 ) Total deferred income tax benefit (31,733 ) (56,879 ) Change in deferred tax valuation allowance (31,733 ) (56,879 ) Total provision for income taxes $ — $ — A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate for the years ended December 31, 2019 and 2018 is as follows: Year Ended December 31, 2019 2018 Federal statutory income tax rate 21.0 % 21.0 % Permanent items -0.5 % -0.1 % State taxes, net of federal benefit (current) 0.0 % 0.0 % State taxes, net of federal benefit (deferred) 6.7 % 6.5 % Change in deferred tax asset valuation allowance -36.7 % -29.9 % Change in prior year credits -0.3 % 0.0 % Current year credits generated 9.8 % 2.5 % Effective income tax rate 0.0 % 0.0 % Net deferred tax assets as of December 31, 2019 and 2018 consisted of the following: December 31, 2019 2018 Deferred tax assets: Stock compensation - NQSO $ 185 $ 67 Charitable contribution carryover 38 5 Accrued bonus 954 557 Accrued vacation 127 31 Other accrued liabilities — 55 Depreciation 14 5 Capitalized acquired patents 37,448 33,771 Capitalized start-up expenses 5,156 2,167 Cumulative net operating loss 31,536 15,833 R&E credit 13,212 4,738 Total deferred tax assets 88,670 57,229 Deferred tax liabilities: Stock Compensation - Restricted Shares (58 ) (350 ) Total deferred tax liabilities (58 ) (350 ) Total net deferred tax assets 88,612 56,879 Less valuation allowance (88,612 ) (56,879 ) Deferred tax asset, net of valuation allowance $ — $ — As of December 31, 2019, the Company had U.S. federal and state net operating loss carryforwards of $114,601 which may be available to offset future taxable income. As of December 31, 2019, the Company also had U.S. federal and state research and development tax credit carryforwards of $13,212. Federal net operating losses generated in 2018 and future years can be carried forward indefinitely. Utilization of the U.S. federal and state net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income or tax liabilities. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s shares at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. Further, until a study is completed and any limitation is known, no amounts are being presented as an uncertain tax position. The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the net deferred tax assets as of December 31, 2019 and 2018. Management reevaluates the positive and negative evidence at each reporting period. As of December 31, 2019 and 2018, no facts or circumstances arose that affected the Company’s determination as to the full valuation established against the net deferred tax assets. As of December 31, 2019 and 2018, the Company had not recorded any amounts for unrecognized tax benefits. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2019 and 2018, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts had been recognized in the Company’s statements of operations and comprehensive loss. The Company files income tax returns in the U.S., Maryland and certain other states, as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending tax examinations. The Company is open to future tax examination under statute from 2018 to the present. |
Benefit Plan
Benefit Plan | 12 Months Ended |
Dec. 31, 2019 | |
Compensation And Retirement Disclosure [Abstract] | |
Benefit Plan | 11. Benefit plan The Company maintains a defined contribution 401(k) plan, under which employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under federal tax regulations. The Company provides an automatic matching contribution of $1.00 per $1.00 of employee contribution into the plan up to a maximum of 4% of employee deferral. The Company’s matching contributions to employees totaled approximately $581 and $179, during the years ended December 31, 2019 and 2018, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and contingencies Contingencies In the ordinary course of business, the Company may become a party to lawsuits involving various matters. The Company is not currently a party, and its properties are not currently subject, to any legal proceedings that, in the opinion of management, are expected to have a material adverse effect on the Company’s business, financial condition or results of operations. Milestone and Royalty Payments At the inception of each license and collaboration agreement with third parties, which may require the Company to make milestone payments, the Company evaluates whether each milestone and royalty payment is substantive and at risk to both parties on the basis of the contingent nature of the milestone and royalty. The Company aggregates milestones into three categories (i) research milestones, (ii) development milestones and (iii) commercial milestones and royalties. Research milestones are typically achieved upon reaching certain criteria as defined in each agreement related to developing a molecule against the specified target. Development milestones are typically reached when a molecule reaches a defined phase of clinical research or passes such phase, or upon gaining regulatory approvals. Commercial milestones and royalties are typically achieved when an approved pharmaceutical product reaches the status for commercial sale or certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. The Company made a regulatory milestone payment of approximately $19,800 in September 2019, in connection with acceptance for review by the FDA of the Company’s Biologics License Application (“BLA”) for inebilizumab in patients with neuromyelitis optica spectrum disorder (“NMOSD”) in August 2019. For the year ended December 31, 2019, the $19,800 regulatory milestone payment was recorded within research and development expenses on the statement of operations. In addition, the Company expects to pay approximately $20,000 if the BLA is approved by the FDA for NMOSD. Employment Agreements The Company has entered into employment agreements with certain of its executive officers. Generally, the terms of these agreements provide that, if the Company terminates the officer other than for cause, death or disability, or if the officer terminates his or her employment with the Company for good cause, the officer shall be entitled to receive certain severance compensation and benefits as described in each such agreement. Office Lease In July 2018, the Company entered into an operating lease agreement with a related party for its headquarters in Gaithersburg, Maryland. The lease became effective July 1, 2018 and expires in June 2021 with the option to extend it by one year. Total lease payments under the lease are: $300 for the year ended December 31, 2018; $365 for the year ended December 31, 2019; $376 for the year ending December 31, 2020; and $191 for the remainder of the lease. In October 2019, the Company entered into an operating lease agreement with a third party for an additional office space in Rockville, Maryland. The lease became effective October 1, 2019 and expires in June 2021. Total lease payments under the lease are: $101 for the year ended December 31, 2019; $407 for the year ending December 31, 2020; and $208 for the remainder of the lease. In October 2019, the Company entered into an operating lease agreement with a third party for an additional lab space in Rockville, Maryland. The lease became effective October 15, 2019 and expires in February 2025. Total lease payments under the lease are: $11 for the year ended December 31, 2019, $103 for the year ending December 31, 2020; and $573 for the remainder of the lease. Rent expense was $344 and $170 for years ended December 31, 2019 and 2018, respectively. Lab Equipment Lease During December 2019, the Company entered into a non-cancelable lease agreement for lab equipment for payments totaling $1,193 over 60 months. The lease commencement date is subject to the delivery and acceptance of the equipment which is currently uncertain. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 13. Related party transactions In connection with the Asset Acquisition, the Company also entered into certain other agreements with the AZ Parties, including transition services agreement, a clinical supply agreement, a commercial supply agreement, a master supply and development services agreement, and a long-term lease agreement. During the year ended December 31, 2019, the Company incurred $41,934 of costs under these agreements, of which $12,892 is recorded as a related party liability on the Company’s balance sheet as of December 31, 2019. During the year ended December 31, 2018, the Company incurred $32,092 of costs under these agreements, of which $12,054 is recorded as a related party liability on the Company’s balance sheet as of December 31, 2018. |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Agreements | 14. Collaboration agreements Commercial license and collaboration agreement with Hansoh On May 24, 2019 (the “Hansoh Effective Date”), the Company entered into an exclusive commercial license and collaboration agreement with Hansoh Pharmaceutical Group Company Limited (“Hansoh”). By entering into this agreement, the Company promised to Hansoh the following goods or services: (i) deliver an exclusive, sub-licensable, license to commercialize any pharmaceutical product that includes inebilizumab, the Company’s lead product candidate, in the mainland of the People’s Republic of China, Hong Kong and Macau (the “Hansoh Territory”) (the “Hansoh Commercial License”); (ii) to use commercially reasonable efforts to obtain regulatory approval from the FDA for a monotherapy use of inebilizumab in connection with the NMOSD indication (“FDA Approval”); (iii) to use commercially reasonable efforts to obtain regulatory approval from the National Medical Products Administration (“NMPA”) for monotherapy use of inebilizumab in connection with the NMOSD indication, as well as any other licensed product containing inebilizumab (including both monotherapy use and in combination with other agents), as approved by the joint coordination committee (“JCC”) in the Territory (“NMPA Approval”); (iv) provide Hansoh the ability to select two or more of the following indications: Non-Hodgkin lymphoma (“NHL”), Chronic lymphocytic leukemia (“CLL”), Multiple Sclerosis (“MS”), Rheumatoid Arthritis (“RA”), Multiple Myeloma (“MM”), and for any other indication that is presented by Hansoh to the Company and approved by the Company to replace one of the predetermined indications for further development in the territory, each of which Hansoh will be responsible for the development and commercialization while the Company will be responsible for performing the regulatory approval activities in the Territory (collectively, the “Selected Indications”); (v) at the Company’s discretion, provide Hansoh with certain participation rights related to the Company’s development and commercialization of other uses of inebilizumab in the Territory, including both monotherapy and in combination with other agents, but excluding the following indications: NMOSD, NHL, CLL, MS, RA and MM (the “Opt-In”). In the event that Hansoh does not elect to participate in these development activities or meet its payment terms with respect to costs incurred in the Territory that are reimbursable to the Company, all commercial rights with respect to the developed indication revert to the Company; and (vi) deliver a co-exclusive license, which provides Hansoh with the exclusive rights to (i) develop inebilizumab, including any clinical trials and other activities directed toward obtaining regulatory approval in the Territory, for all indications within the Selected Indications and (ii) co-develop inebilizumab with the Company for those indications within the Opt-In (the “Co-Development License”). In addition, the Company and Hansoh formed a JCC to provide oversight to the activities performed under the agreement; however, the substance of the Company’s participation in the JCC does not represent an additional promised service, but rather, a right of the Company to protect its own interests in the arrangement. Further, the Company and Hansoh entered into a supply agreement through which the Company shall supply to Hansoh, and Hansoh agrees to purchase from the Company, any and all requirements of any licensed product including inebilizumab for development and commercialization in the Territory during the term. The terms of the supply agreement do not provide for either (i) an option to Hansoh to purchase product from the Company at a discount from the standalone selling price or (ii) minimum purchase quantities. Finally, Hansoh will bear (i) all costs and expenses for any development of inebilizumab for all indications in the Territory subject to the exclusive license and (ii) all costs and fees associated with applying for regulatory approval of any product candidates in the Territory. The Company received a non-refundable upfront payment of $15,000 in June 2019 and an additional $5,000 in December 2019. In addition, the Company has the ability to receive additional payments under the agreement of up to approximately $203,000, including up to $180,000 in commercial milestone payments and development milestone payments ranging from $2,000 to $5,000 on an indication-by-indication basis. The Company is also entitled to receive tiered royalties ranging from the low double-digit percentages to the upper-teen percentages on aggregate net sales of any products developed and commercialized in the Territory, subject to customary potential reductions. The Company assessed this arrangement in accordance with ASC 606 and concluded that the promises summarized above represent transactions with a customer within the scope of ASC 606. The Company determined that the following promises represent distinct promised services, and therefore, separate performance obligations: (i) the Commercialization License, (ii) FDA Approval, (iii) NMPA Approval, (iv) the Selected Indications (inclusive of the Co-Development License) and (y) the Opt-In (inclusive of the Co-Development License). Specifically, in making these determinations, the Company considered the following factors: • Shortly after the Effective Date, the Company received Breakthrough Therapy Designation for the treatment of NMOSD with Inebilizumab from the FDA and the Company submitted a BLA in June 2019. Accordingly, the Company is not promising, nor expecting, to perform additional research and development activities pursuant to the agreement that would either significantly modify or customize or be considered highly interdependent or interrelated with Inebilizumab. • The Commercialization License represents functional intellectual property given the functionality of the Commercialization License is not expected to change substantially as a result of the Company’s ongoing activities. • The Company previously incurred a significant portion of the total estimated costs necessary for FDA Approval prior to the Effective Date. That is, as of the Effective Date, the remaining costs to achieve FDA Approval are expected to be immaterial. • The services necessary to seek NMPA Approval are a readily available resource that are sold separately by third-party vendors. • Hansoh can benefit from both the Selected Indications and the Opt-In together with readily available resources. Further, the Company is not providing a significant service of integration, nor are they significantly modifying or customizing Inebilizumab through these promises. • The Co-Development License does not grant any development rights to Hansoh outside of those indications included within the Selected Indications and the Opt-In. • The Co-Development License is highly interdependent or interrelated with the Selected Indications and the Opt-In. Specifically, (1) the Co-Development License significantly affects the Selected Indications and the Opt-In because in the absence of the Co-Development License, Hansoh would be limited to just selecting certain indications that it would like to develop, but would have no legal right to develop such indication; and (2) the Selected Indications and the Opt-In significantly affect the Co-Development License because the scope of the Co-Development License is limited to the development of Inebilizumab for those indications included within the Selected Indications and the Opt-In. Under the agreement with Hansoh, in order to evaluate the appropriate transaction price, the Company determined that the upfront payment amount of approximately $20,000 constituted the entire consideration to be included in the transaction price as of the outset of the arrangement. While the Company identified multiple performance obligations, this amount was allocated entirely to the Commercialization License performance obligation as the standalone selling price of the remaining performance obligations was deemed to be immaterial at contract inception. In making this determination, the Company observed that the estimated costs associated with both the FDA Approval and NMPA Approval performance obligations are immaterial in the context of the arrangement with Hansoh. In addition, the Company also observed that significant uncertainty existed at the contract inception date related to whether (i) the Company would pursue any indications that would, in-turn, provide Hansoh with an opportunity to utilize the Opt-In (inclusive of the Co-Development License), (ii) Hansoh would pursue the development of any of the Selected Indications (inclusive of the Co-Development License), and (iii) the likelihood that any development activities would ultimately be successful. The potential commercial and development milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone amounts were fully constrained based on the probability of achievement, since the milestones relate to successful achievement of certain commercialization, developmental and regulatory approval goals, which might not be achieved. None of the future royalty payments were included in the transaction price, as the potential payments were determined to be subject to the sales-based royalty exception. The Company will reevaluate the transaction price, including all constrained amounts, at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, and, if necessary, adjust its estimate of the transaction price. Because the entire transaction price was allocated to the Commercialization License performance obligation, which represents functional intellectual property, the Company recognized the associated revenue of $20,000 at the Effective Date. As noted previously, approximately $15,000 of the total upfront payment was received within 30 days after the Effective Date. The remaining $5,000 was received within six months after the Effective Date. Commercial license and collaboration agreement with Mitsubishi Tanabe Pharma Corporation On October 8, 2019 (“MTPC Transaction Date”), the Company entered into an exclusive commercial license agreement with Mitsubishi Tanabe Pharma Corporation (“MTPC”). By entering into this agreement, the Company promised to MTPC the following goods or services: (i) to transfer an exclusive, sub-licensable, license to develop and commercialize any pharmaceutical product that includes inebilizumab (“Product”), the Company’s lead product candidate, in Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, Philippines, Singapore and Taiwan (“MTPC Territory”) (collectively, the “MTPC License”). (ii) at the Company’s discretion, provide MTPC with certain participation rights related to the Company’s development and commercialization of other life cycle management (LCM) uses of inebilizumab in the MTPC Territory, but excluding the NMOSD indication (the “LCM Opt-in”). In addition, the Company and MTPC formed a joint steering committee (“JSC”) to provide oversight to the activities performed under the agreement; however, t The agreement requires MTPC to pay to the Company a non-refundable upfront payment of $30,000. The entire upfront payment was received in January 2020 and was included within accounts receivable as of December 31, 2019 as the Company had a contractual right to bill for the entire amount as of the balance sheet date. In addition, the Company can receive additional payments upon achieving certain sales milestones related to other LCM indications. The Company assessed this arrangement in accordance with ASC 606 and concluded that the agreement represents a contract with a customer within the scope of ASC 606. The Company determined that the following promises represent distinct promised services, and therefore, separate performance obligations: (i) the MTPC License and (ii) the LCM Opt-in. Specifically, in making these determinations, the Company considered the following factors: • The MTPC License represents functional intellectual property given the functionality of the MTPC License is not expected to change substantially as a result of the Company’s ongoing activities. To this point, on August 27, 2019, the FDA accepted for review the Company’s BLA for inebilizumab (NMOSD indication). • Under the agreement, the Company is not providing any substantive research, development, regulatory or other activities that would transfer a service to MTPC given the status of inebilizumab (NMOSD indication) as a late-stage clinical drug as of the MTPC Transaction Date. • MTPC can benefit from the LCM Option together with readily available resources. Further, the Company is not providing a significant service of integration, nor are they significantly modifying or customizing inebilizumab through this promise. In identifying the appropriate transaction price to allocate to the MTPC License, the Company determined that the upfront payment amount of $30,000 constituted the entire consideration to be included in the transaction price as of the outset of the arrangement. While the Company identified multiple performance obligations, this amount was allocated entirely to the MTPC License performance obligation as the standalone selling price of the remaining performance obligation was deemed to be immaterial at contract inception. In making this determination, the Company observed that significant uncertainty existed at the MTPC Transaction Date related to whether the Company would pursue any LCM indications that would, in-turn, provide MTPC with an opportunity to utilize the LCM Opt-in. The potential first commercial sale milestone payments related to a Product for each LCM Indication in Japan were excluded from the transaction price as these payments were determined to be subject to the sales-based royalty exception. A portion of the price of Product supplied to MTPC, which is calculated as a range of percentages of MTPC’s net selling price in the MTPC Territory, will also be subject to the sales-based royalty exception. Because the entire transaction price was allocated to the MTPC License performance obligation, which represents functional intellectual property, the Company recognized the associated revenue of $30,000 at the MTPC Transaction Date. |
Quarterly Financial Information
Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information (Unaudited) | 15. Quarterly financial information (unaudited) First Second Third Fourth Quarter Quarter Quarter Quarter Year Ended December 31, 2019 Revenues $ — $ 20,000 $ — $ 30,000 Loss from operations (21,652 ) (6,107 ) (48,930 ) (13,002 ) Net loss (20,976 ) (5,473 ) (48,410 ) (11,569 ) Net loss per share, basic and diluted (167.38 ) (8.94 ) (64.59 ) (0.24 ) Year Ended December 31, 2018 Revenues $ — $ — $ — $ — Loss from operations (147,392 ) (12,902 ) (16,329 ) (15,688 ) Net loss (147,291 ) (12,244 ) (15,682 ) (15,053 ) Net loss per share, basic and diluted (14,729,074 ) (1,224,372 ) (1,568,200 ) (1,505,319 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of estimates The preparation of the Company’s financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the recognition of research and development expenses based on when services are performed, the valuations of share based compensation arrangements, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and cash equivalents Cash equivalents represent highly liquid instruments with an original maturity of 90 days or less at acquisition. Cash and cash equivalents include investments in money market funds with commercial banks and financial institutions, and commercial paper of high-quality corporate issuers. |
Marketable Securities | Marketable Securities The Company’s marketable securities, consisting of debt securities, are classified as available-for-sale and are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholder’s equity (deficit). Realized gains and losses and declines in value determined to be other than temporary are based on the specific identification method and are included as a component of other income (expense), net in the statements of operations and comprehensive loss. Marketable securities that mature within one year from the balance sheet date are classified as current. The Company evaluates its marketable securities with unrealized losses for other-than-temporary impairment. When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustments to fair value reflects a decline in the value of the investment that the Company considers to be “other-than-temporary”, the Company reduces the investment to fair value through a charge to the statements of operations and comprehensive loss. No such adjustments were necessary during the periods presented. |
Concentrations of Credit Risk | Concentrations of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and the Company’s money market fund investment. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. |
Fair Value Measurements | Fair value measurements Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined 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. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying amount of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and accounts payable approximate their fair values. No transfer of assets between Level 1 and Level 2 of the fair value hierarchy occurred during the years ended December 31, 2019 and 2018. |
Segment Information | Segment information The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is developing and commercializing transformative treatments for severe inflammation and autoimmune diseases. |
Research and Development Expenses | Research and development expenses Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including personnel expenses, stock-based compensation expense, allocated facility-related and depreciation expenses, third-party license fees and external costs including fees paid to consultants and clinical research organizations (“CROs”), in connection with nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Costs incurred in purchasing technology or technology licenses are charged immediately to research and development expense if the technology has not reached technological feasibility and has no alternative future uses. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. A majority of these payments are pass-through payments that are made to AZ Parties due to the existing contracts in place associated with the in-process research and development (“IPR&D”) assets acquired (see Note 8, "Asset acquisition"). The Company, primarily through the AZ Parties outsources a substantial portion of its clinical trial activities, utilizing external entities such as CROs, independent clinical investigators, and other third-party service providers to assist it with the execution of its clinical studies. For each clinical trial that the Company conducts, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter the trial, and/or the period over which clinical investigators or CROs are expected to provide services. Clinical activities which relate principally to clinical sites and other administrative functions to manage the Company’s clinical trials are performed primarily by CROs. CROs typically perform most of the start-up activities for the Company’s trials, including document preparation, site identification, screening and preparation, pre-study visits, training, and program management. These start-up costs usually occur within a few months after the contract has been executed and are event-driven in nature. The remaining activities and related costs, such as patient monitoring and administration, generally occur ratably throughout the life of the individual contract or study. In the event of early termination of a clinical trial, the Company accrues and recognizes expenses in an amount based on its estimate of the remaining non-cancelable obligations associated with the winding down of the clinical trial and/or penalties. For clinical study sites, where payments are made periodically on a per-patient basis to the institutions performing the clinical study, the Company accrues expenses on an estimated cost-per-patient basis, based on subject enrollment and activity in each period. The amount of clinical study expense recognized may vary from period to period based on the duration and progress of the study, the activities to be performed by the sites each quarter, the required level of patient enrollment, the rate at which patients actually enroll in and drop out of the clinical study, and the number of sites involved in the study. Clinical trials that bear the greatest risk of change in estimates are typically those that have a significant number of sites, require a large number of patients, have complex patient screening requirements, and span multiple years. During the course of a trial, the Company adjusts its rate of clinical expense recognition if actual results differ from the Company’s estimates. The Company’s estimates and assumptions for clinical expense recognition could differ significantly from the Company’s actual results, which could cause material increases or decreases in research and development expenses in future periods when the actual results become known. |
Patent Costs | Patent costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. |
Property and Equipment | Property and equipment Property and equipment, which consists mainly of laboratory equipment, are carried at cost less accumulated depreciation. Depreciation expense is recognized using straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Machinery and equipment 5 years Furniture and fixtures 7 years Leasehold improvements Lesser of lease term or life of asset Expenditures for maintenance and repairs which do not materially extend the useful lives of the assets are charged to expense as incurred. The cost and accumulated depreciation or amortization of assets either retired or sold are removed from the respective accounts, and any gain or loss is recognized in operations. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. The Company did not record any impairment losses on long-lived assets during the years ended December 31, 2019 and 2018. |
Revenue Recognition for Contracts with Customers | Revenue Recognition for Contracts with Customers To date, the Company has recognized revenues through commercialization and collaboration agreements. Effective January 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2014-09, Revenue (ASC 606): Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. Under this method, results for reporting periods beginning on January 1, 2019 are presented under ASC 606, while prior periods were prepared and reported in accordance with ASC Topic 605, Revenue Recognition (“ASC 605”). The adoption of ASC 606 resulted in no cumulative adjustment as the Company had substantially no assets until executing the Asset Acquisition in February 2018 (as described in Note 8, "Asset acquisition") and did not enter into a revenue contract with a customer until May 2019 (as described in Note 14, "Collaboration agreements"). ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. We assess if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method. Amounts recognized as revenue for which the Company has the contractual right to bill, but has not yet received, are classified as accounts receivable in the accompanying balance sheets. Amounts recognized as revenue for which the Company does not have the contractual right to bill are generally recognized as contract assets in the accompanying balance sheets. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current liabilities in the accompanying balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as long-term liabilities. Licenses of Intellectual Property – The terms of the Company’s contracts with customers may include the license of functional intellectual property, given the functionality of the intellectual property is not expected to change substantially as a result of the Company’s ongoing activities. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the portion of the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises (that is, for licenses that are not distinct from other promised goods and services in an arrangement), the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments – If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. Royalties – For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue or milestone payments resulting from any of its licensing arrangements. Significant Financing Component – In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. Collaborative Arrangements – The Company enters into collaboration agreements, which are within the scope of ASC 606, to discover, develop, manufacture or commercialize product candidates. The terms of these agreements typically contain multiple promises or obligations, which may include: (1) licenses, or options to obtain licenses, to use the Company’s technology, (2) research and development activities to be performed on behalf of the collaboration partner, and (3) in certain cases, services in connection with the manufacturing of preclinical and clinical material. Payments the Company receives under these arrangements typically include one or more of the following: non-refundable, upfront license fees; clinical and development, regulatory, and sales milestone payments; and royalties on future product sales. The Company also analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 606. For those elements of the arrangement that are accounted for pursuant to ASC 606, the Company applies the five-step model described above. |
Stock-based Compensation | Stock-based compensation The Company measures all stock-based awards granted to employees based on the fair value on the date of the grant and recognizes compensation expense into either general and administrative expense or research and development expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The Company accounts for forfeitures as they occur. For stock-based awards with service-based vesting conditions, the Company recognizes compensation expense using the straight-line method. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option The Company classifies stock-based compensation expense in its statement of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. |
Common Stock Valuations | Common stock valuations Prior to the IPO, because there was no public market for our common stock as we were a private company, our board of directors determined the fair value of our common stock by considering a number of objective and subjective factors, including having contemporaneous and retrospective valuations of our equity performed by a third-party valuation specialist, valuations of comparable peer public companies, sales of our convertible preferred stock, operating and financial performance, the lack of liquidity of our common stock, and general and industry-specific economic outlook. Following our IPO, the closing sale price per share of our common stock as reported on The Nasdaq Global Select Market on the date of grant is used to determine the fair value exercise price per share of our share-based awards to purchase common stock. |
Income Taxes | Income taxes The Company accounts for income taxes in accordance with ASC Topic 740, Income Taxes The Company recognizes the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2019 the Company had no unrecognized tax benefits and as such, no liability, interest or penalties were required to be recorded. The Company does not expect this to change significantly in the next twelve months. |
Net Loss Per Share | Net loss per share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Prior to the IPO, the Company followed the two-class method when computing net loss per share, which is an earnings allocation formula that determines net loss per share for the holders of the Company’s common shares and participating securities. The Company’s Preferred Stock contains participating rights in any dividend paid by the Company and are deemed to be participating securities. Net income attributable to common stockholders and participating preferred shares is allocated to each share on an as-converted basis as if all of the earnings for the period had been distributed. The participating securities do not include a contractual obligation to share in the losses of the Company and are not included in the calculation of net loss per share in the periods that have a net loss. Common equivalent shares are excluded from the computation in periods in which they have an anti-dilutive effect on net loss per share. Diluted net loss per share is computed using the more dilutive of (a) the two-class method or (b) the if-converted method. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Diluted net loss per share is equivalent to basic net loss per share for the periods presented herein because common stock equivalent shares from the Series A and Series B Preferred Stock were anti-dilutive. Due to their anti-dilutive effect, the calculation of diluted net loss per share for the year ended December 31, 2018 does not include 31,225,324 shares of Series A Preferred Stock. Subsequent to the IPO, basic net loss per common share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options. Accordingly, in periods in which the Company reported a net loss, dilutive common shares were not included in the calculation as their affect was anti-dilutive, and as a result, diluted net loss per common share was the same as basic net loss per common share for the year ended December 31, 2019. For the years ended December 31, 2019 and 2018, there were no reconciling items between basic and diluted net loss per share. |
Emerging Growth Company | Emerging growth company The Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. The Company has elected this exemption to delay adopting new or revised accounting standards until such time as those standards apply to private companies. Where allowable, the Company has early adopted certain standards as described below. |
Recently Adopted and Issued Accounting Pronouncements | Recently adopted accounting pronouncements In January 2017, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business In May 2017, the FASB issued ASU No. 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and ASC 606 (“ASU 2018-18”). The amendments in ASU 2018-18 make targeted improvements to GAAP for collaborative arrangements by clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in ASC 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. In addition, unit-of-account guidance in ASU 2018-18 was aligned with the guidance in ASC 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of ASC 606. The amendments should be applied retrospectively to the date of initial application of ASC 606. The Company adopted this guidance effective January 1, 2019 with its initial application of ASC 606. The adoption of the standard did not have an impact on the Company’s financial statements. Recently issued accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) For all other entities, the ASU is effective for annual periods beginning after December 15, 2020, . In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) (Part I) Accounting for Certain Financial Instruments with Down Round Features (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception In August 2018, the FASB issued No. ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Life of Asset | Property and equipment, which consists mainly of laboratory equipment, are carried at cost less accumulated depreciation. Depreciation expense is recognized using straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Machinery and equipment 5 years Furniture and fixtures 7 years Leasehold improvements Lesser of lease term or life of asset |
Cash, Cash Equivalents and Ma_2
Cash, Cash Equivalents and Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Cash, Cash Equivalents and Available-For-Sale Marketable Securities | The following is a summary of the Company’s cash, cash equivalents and available-for-sale marketable securities by significant investment category: December 31, 2019 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Current Marketable Securities Non-Current Marketable Securities Cash $ 26,821 $ — $ — $ 26,821 $ 26,821 $ — $ — Level 1 Money market funds 157,777 — — 157,777 157,777 — — Subtotal 157,777 — — 157,777 157,777 — — Level 2 U.S. Treasury securities 9,623 7 — 9,630 — 4,805 4,825 Commercial paper 55,021 4 (9 ) 55,016 13,050 41,966 — Corporate debt securities 96,964 28 (25 ) 96,967 3,203 67,174 26,590 Subtotal 161,608 39 (34 ) 161,613 16,253 113,945 31,415 Total $ 346,206 $ 39 $ (34 ) $ 346,211 $ 200,851 $ 113,945 $ 31,415 December 31, 2018 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Cash and Cash Equivalents Current Marketable Securities Non-Current Marketable Securities Cash $ 21,681 $ — $ — $ 21,681 $ 21,681 $ — $ — Level 1 Money market funds 105,217 — — 105,217 105,217 — — Total $ 126,898 $ — $ — $ 126,898 $ 126,898 $ — $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | The following is a summary of the Company’s property and equipment, at cost: December 31, 2019 2018 Machinery and equipment $ 930 $ 491 Furniture and fixtures 359 — Leasehold improvements 412 — Total 1,701 491 Accumulated depreciation and amortization (202 ) (18 ) Total, net $ 1,499 $ 473 |
Accrued Liabilities and Other_2
Accrued Liabilities and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Liabilities and Other Current Liabilities | The following is a summary of the Company’s accrued liabilities and other current liabilities as of December 31, 2019 and 2018: As of December 31, 2019 2018 Compensation and employee benefits $ 4,684 $ 2,224 Research and development expenses 2,693 61 Consulting and other professional fees 1,475 439 Other 340 45 Total $ 9,192 $ 2,769 |
Convertible Redeemable Prefer_2
Convertible Redeemable Preferred Stock (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Temporary Equity [Abstract] | |
Summary of Redeemable Convertible Preferred Stock | At December 31, 2018, the Company’s redeemable convertible preferred stock consisted of the following: Preferred Stock Authorized Preferred Stock Issued and Outstanding Carrying Value Series A-1 Preferred Stock 14,225,324 14,225,324 $ 142,253 Series A-2 Preferred Stock 17,000,000 17,000,000 170,000 Series A-3 Preferred Stock 6,470,588 — — Total 37,695,912 31,225,324 $ 312,253 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Fair Value of Option Awards Granted Using Black-Scholes Assumptions | The fair value of the Company’s option awards granted during the years ended December 31, 2019 and 2018, was estimated using the following assumptions: Year Ended December 31, 2019 2018 Risk-free rate of interest 1.45 - 2.52% 2.87 % Expected term (years) 5.50 - 6.24 6.00 Expected stock price volatility 62.50 - 84.61% 83.30 % Dividend yield 0.00 % 0.00 % Weighted average fair value of common stock $ 13.75 $ 2.84 |
Schedule of Company's Stock Option Activity | The following table summarizes the Company’s stock option activity for the year ended December 31, 2019: Number of options Weighted- average exercise price Weighted- average remaining contractual term (years) Outstanding at December 31, 2018 2,485,650 2.84 9.25 Granted 1,460,520 13.75 Exercised (535,363 ) 2.84 Cancelled (123,550 ) 3.96 Outstanding at December 31, 2019 3,287,257 7.65 8.82 Exercisable at December 31, 2019 500,647 2.86 8.20 Vested and expected to vest at December 31, 2019 3,287,257 7.65 8.82 |
Summary of Restricted Stock Awards (RSA) Outstanding | The following table summarizes the information about restricted stock awards (“RSA”) outstanding for the year ended December 31, 2019: Number of shares Grant-date fair value Unvested as of December 31, 2018 757,577 $ 2.84 Granted — — Vested/Released (378,789 ) 2.84 Cancelled (6,631 ) 2.84 Unvested as of December 31, 2019 372,157 $ 2.84 |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense for the years ended December 31, 2019 and 2018 was comprised of the following: Year Ended December 31, 2019 2018 Research and development $ 1,820 $ 935 General and administrative 1,805 944 Total stock-based compensation expense $ 3,625 $ 1,879 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Summary of Current and Deferred Tax Provision | A summary of the Company’s current and deferred tax provision is as follows: December 31, 2019 December 31, 2018 Current income tax provision: Federal $ — $ — State — — Total current income tax provision — — Deferred income tax benefit: Federal (25,926 ) (44,529 ) State (5,807 ) (12,350 ) Total deferred income tax benefit (31,733 ) (56,879 ) Change in deferred tax valuation allowance (31,733 ) (56,879 ) Total provision for income taxes $ — $ — |
Summary of Reconciliation of U.S. Federal Statutory Income Tax Rate to Effective Income Tax Rate | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate for the years ended December 31, 2019 and 2018 is as follows: Year Ended December 31, 2019 2018 Federal statutory income tax rate 21.0 % 21.0 % Permanent items -0.5 % -0.1 % State taxes, net of federal benefit (current) 0.0 % 0.0 % State taxes, net of federal benefit (deferred) 6.7 % 6.5 % Change in deferred tax asset valuation allowance -36.7 % -29.9 % Change in prior year credits -0.3 % 0.0 % Current year credits generated 9.8 % 2.5 % Effective income tax rate 0.0 % 0.0 % |
Components of Net Deferred Tax Assets | Net deferred tax assets as of December 31, 2019 and 2018 consisted of the following: December 31, 2019 2018 Deferred tax assets: Stock compensation - NQSO $ 185 $ 67 Charitable contribution carryover 38 5 Accrued bonus 954 557 Accrued vacation 127 31 Other accrued liabilities — 55 Depreciation 14 5 Capitalized acquired patents 37,448 33,771 Capitalized start-up expenses 5,156 2,167 Cumulative net operating loss 31,536 15,833 R&E credit 13,212 4,738 Total deferred tax assets 88,670 57,229 Deferred tax liabilities: Stock Compensation - Restricted Shares (58 ) (350 ) Total deferred tax liabilities (58 ) (350 ) Total net deferred tax assets 88,612 56,879 Less valuation allowance (88,612 ) (56,879 ) Deferred tax asset, net of valuation allowance $ — $ — |
Quarterly Financial Informati_2
Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | First Second Third Fourth Quarter Quarter Quarter Quarter Year Ended December 31, 2019 Revenues $ — $ 20,000 $ — $ 30,000 Loss from operations (21,652 ) (6,107 ) (48,930 ) (13,002 ) Net loss (20,976 ) (5,473 ) (48,410 ) (11,569 ) Net loss per share, basic and diluted (167.38 ) (8.94 ) (64.59 ) (0.24 ) Year Ended December 31, 2018 Revenues $ — $ — $ — $ — Loss from operations (147,392 ) (12,902 ) (16,329 ) (15,688 ) Net loss (147,291 ) (12,244 ) (15,682 ) (15,053 ) Net loss per share, basic and diluted (14,729,074 ) (1,224,372 ) (1,568,200 ) (1,505,319 ) |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2019 | Feb. 28, 2018 | Dec. 31, 2019 | |
Subsidiary Sale Of Stock [Line Items] | |||
Net proceeds | $ 172,615 | ||
Common Stock | |||
Subsidiary Sale Of Stock [Line Items] | |||
Issuance of common stock | 9,085,000 | ||
Number of outstanding preferred stock converted into aggregate shares of common stock | 40,618,706 | 40,618,706 | |
IPO | |||
Subsidiary Sale Of Stock [Line Items] | |||
Issuance of common stock | 7,900,000 | ||
Common stock price per share | $ 19 | ||
Gross proceeds | $ 150,100 | ||
Net proceeds | 135,988 | ||
Underwriting discounts and commissions and other offering expenses | $ 14,112 | ||
Underwriter's Option to Purchase Additional Shares | |||
Subsidiary Sale Of Stock [Line Items] | |||
Issuance of common stock | 1,185,000 | ||
Gross proceeds | $ 22,515 | ||
Net proceeds | 20,939 | ||
Underwriting discounts and commissions and other offering expenses | 1,576 | ||
Aggregate Gross Proceeds from IPO | |||
Subsidiary Sale Of Stock [Line Items] | |||
Gross proceeds | 172,615 | ||
Net proceeds | $ 156,927 | ||
Asset Purchase Agreement | |||
Subsidiary Sale Of Stock [Line Items] | |||
Assets purchase price | $ 142,253 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule Of Significant Accounting Policies [Line Items] | ||
Fair value hierarchy, transfer of assets from level 1 to level 2 | $ 0 | $ 0 |
Fair value hierarchy, transfer of assets from level 2 to level 1 | 0 | 0 |
Fair value hierarchy, transfer of liabilities from level 1 to level 2 | 0 | 0 |
Fair value hierarchy, transfer of liabilities from level 2 to level 1 | 0 | 0 |
Impairment losses on long lived assets | 0 | 0 |
Unrecognized tax benefits | $ 0 | $ 0 |
Series A Preferred Stock | ||
Schedule Of Significant Accounting Policies [Line Items] | ||
Anti-dilutive shares excluded from calculation of diluted net loss per share | 31,225,324 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Estimated Useful Life of Asset (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Machinery and Equipment | |
Schedule Of Significant Accounting Policies [Line Items] | |
Property and equipment, estimated useful life | 5 years |
Furniture and Fixtures | |
Schedule Of Significant Accounting Policies [Line Items] | |
Property and equipment, estimated useful life | 7 years |
Leasehold Improvements | |
Schedule Of Significant Accounting Policies [Line Items] | |
Property and equipment, estimated useful life | Lesser of lease term or life of asset |
Cash, Cash Equivalents and Ma_3
Cash, Cash Equivalents and Marketable Securities - Summary of Cash, Cash Equivalents and Available-For-Sale Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Marketable Securities [Line Items] | ||
Cash, cash equivalents and available-for-sale marketable securities, Amortized Cost | $ 346,206 | $ 126,898 |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Gains | 39 | |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Losses | (34) | |
Cash, cash equivalents and available-for-sale marketable securities, Fair Value | 346,211 | 126,898 |
Cash and cash equivalents | 200,851 | 126,898 |
Current Marketable Securities | 113,945 | |
Non-Current Marketable Securities | 31,415 | |
Cash | ||
Marketable Securities [Line Items] | ||
Cash, cash equivalents and available-for-sale marketable securities, Amortized Cost | 26,821 | 21,681 |
Cash, cash equivalents and available-for-sale marketable securities, Fair Value | 26,821 | 21,681 |
Cash and cash equivalents | 26,821 | 21,681 |
Level 1 | ||
Marketable Securities [Line Items] | ||
Cash, cash equivalents and available-for-sale marketable securities, Amortized Cost | 157,777 | |
Cash, cash equivalents and available-for-sale marketable securities, Fair Value | 157,777 | |
Cash and cash equivalents | 157,777 | |
Level 1 | Money Market Funds | ||
Marketable Securities [Line Items] | ||
Cash, cash equivalents and available-for-sale marketable securities, Amortized Cost | 157,777 | 105,217 |
Cash, cash equivalents and available-for-sale marketable securities, Fair Value | 157,777 | 105,217 |
Cash and cash equivalents | 157,777 | $ 105,217 |
Level 2 | ||
Marketable Securities [Line Items] | ||
Cash, cash equivalents and available-for-sale marketable securities, Amortized Cost | 161,608 | |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Gains | 39 | |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Losses | (34) | |
Cash, cash equivalents and available-for-sale marketable securities, Fair Value | 161,613 | |
Cash and cash equivalents | 16,253 | |
Current Marketable Securities | 113,945 | |
Non-Current Marketable Securities | 31,415 | |
Level 2 | U.S. Treasury Securities | ||
Marketable Securities [Line Items] | ||
Cash, cash equivalents and available-for-sale marketable securities, Amortized Cost | 9,623 | |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Gains | 7 | |
Cash, cash equivalents and available-for-sale marketable securities, Fair Value | 9,630 | |
Current Marketable Securities | 4,805 | |
Non-Current Marketable Securities | 4,825 | |
Level 2 | Corporate Debt Securities | ||
Marketable Securities [Line Items] | ||
Cash, cash equivalents and available-for-sale marketable securities, Amortized Cost | 96,964 | |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Gains | 28 | |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Losses | (25) | |
Cash, cash equivalents and available-for-sale marketable securities, Fair Value | 96,967 | |
Cash and cash equivalents | 3,203 | |
Current Marketable Securities | 67,174 | |
Non-Current Marketable Securities | 26,590 | |
Level 2 | Commercial Paper | ||
Marketable Securities [Line Items] | ||
Cash, cash equivalents and available-for-sale marketable securities, Amortized Cost | 55,021 | |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Gains | 4 | |
Cash, cash equivalents and available-for-sale marketable securities, Unrealized Losses | (9) | |
Cash, cash equivalents and available-for-sale marketable securities, Fair Value | 55,016 | |
Cash and cash equivalents | 13,050 | |
Current Marketable Securities | $ 41,966 |
Cash, Cash Equivalents and Ma_4
Cash, Cash Equivalents and Marketable Securities - Additional Information (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Marketable Securities [Line Items] | ||
Available for sale marketable securities | $ 0 | |
Minimum | ||
Marketable Securities [Line Items] | ||
Long-term marketable securities, maturity | 1 year | |
Maximum | ||
Marketable Securities [Line Items] | ||
Long-term marketable securities, maturity | 2 years |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Total | $ 1,701 | $ 491 |
Accumulated depreciation and amortization | (202) | (18) |
Total, net | 1,499 | 473 |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total | 930 | $ 491 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Total | 359 | |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total | $ 412 |
Accrued Liabilities and Other_3
Accrued Liabilities and Other Current Liabilities - Summary of Accrued Liabilities and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Compensation and employee benefits | $ 4,684 | $ 2,224 |
Research and development expenses | 2,693 | 61 |
Consulting and other professional fees | 1,475 | 439 |
Other | 340 | 45 |
Total | $ 9,192 | $ 2,769 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Equity [Abstract] | |
Dividends | $ 0 |
Convertible Redeemable Prefer_3
Convertible Redeemable Preferred Stock - Additional Information (Details) | Oct. 03, 2019shares | Feb. 23, 2018USD ($)$ / sharesshares | Oct. 31, 2019USD ($)shares | Sep. 30, 2019USD ($)$ / sharesshares | Jun. 30, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)shares | Dec. 31, 2019USD ($)Director$ / shares | Dec. 31, 2018USD ($)shares |
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Redeemable convertible preferred stock | 37,695,912 | 37,695,912 | ||||||
Proceeds from issuance of redeemable convertible preferred stock | $ | $ 282,253,000 | $ 167,000,000 | $ 300,253,000 | |||||
Receivables from redeemable convertible preferred stock | $ | $ 12,000,000 | 12,000,000 | ||||||
Number of directors | Director | 8 | |||||||
Dividends declared or paid | $ | $ 0 | |||||||
Proceeds from public offering | $ | $ 172,615,000 | |||||||
Common Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Preferred stock, liquidation preference | $ | $ 312,253,000 | $ 312,253,000 | ||||||
Maximum | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Shares issued, price per share | $ / shares | $ 17.60 | |||||||
Minimum | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Proceeds from public offering | $ | $ 75,000,000 | |||||||
Series A-1 Preferred Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Redeemable convertible preferred stock | 14,225,324 | 14,225,324 | ||||||
Convertible redeemable preferred stock, shares issued | 14,225,324 | |||||||
Redeemable convertible preferred stock,Per share | $ / shares | $ 0.001 | |||||||
Convertible redeemable preferred stock purchase price per share | $ / shares | $ 10 | |||||||
Preferred stock holder entitled to elect number of directors | Director | 2 | |||||||
Series A-2 Preferred Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Redeemable convertible preferred stock | 17,000,000 | 17,000,000 | ||||||
Convertible redeemable preferred stock, shares issued | 14,000,000 | |||||||
Redeemable convertible preferred stock,Per share | $ / shares | $ 0.001 | |||||||
Convertible redeemable preferred stock purchase price per share | $ / shares | 10 | |||||||
Proceeds from issuance of redeemable convertible preferred stock | $ | $ 30,000,000 | |||||||
Convertible redeemable preferred stock issuance of additional shares | 3,000,000 | |||||||
Convertible redeemable preferred stock additional price per shares | $ / shares | $ 10 | |||||||
Receivables from redeemable convertible preferred stock | $ | $ 12,000,000 | $ 12,000,000 | ||||||
Percentage of redeemable convertible preferred stock converted to common stock redeemed | 90.00% | |||||||
Preferred stock holder entitled to elect number of directors | Director | 4 | |||||||
Series A-2 Preferred Stock | Maximum | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Convertible redeemable preferred stock issuance of additional shares | 3,000,000 | |||||||
Series A-3 Preferred Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Redeemable convertible preferred stock | 6,470,588 | 6,470,588 | ||||||
Convertible redeemable preferred stock, shares issued | 4,705,882 | |||||||
Convertible redeemable preferred stock purchase price per share | $ / shares | $ 17 | $ 17 | ||||||
Proceeds from issuance of redeemable convertible preferred stock | $ | $ 80,000,000 | |||||||
Series A-3 Preferred Stock | Maximum | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Convertible redeemable preferred stock, shares issued | 6,470,588 | |||||||
Series B Preferred Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Convertible redeemable preferred stock, shares issued | 4,687,500 | |||||||
Convertible redeemable preferred stock purchase price per share | $ / shares | $ 16 | |||||||
Proceeds from issuance of redeemable convertible preferred stock | $ | $ 75,000,000 | |||||||
Preferred stock holder entitled to elect number of directors | Director | 1 | |||||||
Preferred stock, dividend per share | $ / shares | $ 1.28 | |||||||
Preferred Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Preferred stock holder entitled to elect number of directors | Director | 7 | |||||||
Series A Redeemable Convertible Preferred Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Affirmative vote of outstanding shares percentage | 75.00% | |||||||
Series A-2 and A-3 Redeemable Convertible Preferred Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Affirmative vote of outstanding shares percentage | 75.00% | |||||||
IPO | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Redeemable convertible preferred stock | 40,618,706 | |||||||
Proceeds from public offering | $ | $ 135,988,000 | |||||||
IPO | Common Stock | ||||||||
Redeemable Convertible Preferred Stock [Line Items] | ||||||||
Number of outstanding preferred stock converted into aggregate shares of common stock | 40,618,706 |
Convertible Redeemable Prefer_4
Convertible Redeemable Preferred Stock - Summary of Redeemable Convertible Preferred Stock (Details) $ in Thousands | Dec. 31, 2018USD ($)shares |
Redeemable Convertible Preferred Stock [Line Items] | |
Preferred Stock Authorized | 37,695,912 |
Preferred Stock Issued and Outstanding | 31,225,324 |
Carrying Value | $ | $ 312,253 |
Series A-1 Preferred Stock | |
Redeemable Convertible Preferred Stock [Line Items] | |
Preferred Stock Authorized | 14,225,324 |
Preferred Stock Issued and Outstanding | 14,225,324 |
Carrying Value | $ | $ 142,253 |
Series A-2 Preferred Stock | |
Redeemable Convertible Preferred Stock [Line Items] | |
Preferred Stock Authorized | 17,000,000 |
Preferred Stock Issued and Outstanding | 17,000,000 |
Carrying Value | $ | $ 170,000 |
Series A-3 Preferred Stock | |
Redeemable Convertible Preferred Stock [Line Items] | |
Preferred Stock Authorized | 6,470,588 |
Asset Acquisition - Additional
Asset Acquisition - Additional Information (Details) - In-process Research and Development - AZ Parties $ in Thousands | 1 Months Ended |
Feb. 28, 2018USD ($) | |
Finite Lived Intangible Assets [Line Items] | |
Purchase price of asset acquisition | $ 142,253 |
Direct and incremental transaction expenses | $ 1,000 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of options vested or exercisable | 500,647 | 0 |
Weighted average grant date fair value per share of options granted | $ 9.25 | $ 1.99 |
Aggregate intrinsic value of options exercised | $ 2,100 | |
Aggregate intrinsic value of options vested and expected to vest | 64,116 | |
Aggregate intrinsic value of options vested and exercisable | 12,158 | |
Total unrecognized compensation expense related to unvested stock options | $ 14,708 | |
Unvested stock option recognized over period | 3 years 3 months 10 days | |
2018 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation, number of common stock shares for issuance under plan | 5,541,224 | |
Stock Option | 2018 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation, vesting period | 4 years | 4 years |
Stock Option | 2018 Equity Incentive Plan | Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation, contractual term | 10 years | 10 years |
Restricted Stock Awards (RSA) | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation, vesting period | 2 years | |
Unvested stock option recognized over period | 3 months | |
Total unrecognized compensation expense related to restricted stock grants | $ 197 | |
Restricted Stock Awards (RSA) | Tranche One | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock vesting percentage | 50.00% | |
Restricted Stock Awards (RSA) | Tranche Two | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock vesting percentage | 50.00% | |
Restricted Stock Awards (RSA) | 2018 Equity Incentive Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation, vesting period | 2 years |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Fair Value of Option Awards Granted Using Black-Scholes Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free rate of interest | 2.87% | |
Risk-free rate of interest, minimum | 1.45% | |
Risk-free rate of interest, maximum | 2.52% | |
Expected term (years) | 6 years | |
Expected stock price volatility | 83.30% | |
Expected stock price volatility, minimum | 62.50% | |
Expected stock price volatility, maximum | 84.61% | |
Dividend yield | 0.00% | 0.00% |
Weighted average fair value of common stock | $ 13.75 | $ 2.84 |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 5 years 6 months | |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 6 years 2 months 26 days |
Stock-based compensation - Sc_2
Stock-based compensation - Schedule of Company's Stock Option Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Number of options, Outstanding at December 31, 2018 | 2,485,650 | |
Number of options, Granted | 1,460,520 | |
Number of options, Exercised | (535,363) | |
Number of options, Cancelled | (123,550) | |
Number of options, Outstanding at December 31, 2019 | 3,287,257 | 2,485,650 |
Number of options, Exercisable at December 31, 2019 | 500,647 | 0 |
Number of options, Vested and expected to vest at December 31, 2019 | 3,287,257 | |
Weighted-average exercise price, Outstanding at December 31, 2018 | $ 2.84 | |
Weighted-average exercise price, Granted | 13.75 | |
Weighted-average exercise price, Exercised | 2.84 | |
Weighted-average exercise price, Cancelled | 3.96 | |
Weighted-average exercise price, Outstanding at December 31, 2019 | 7.65 | $ 2.84 |
Weighted-average exercise price, Exercisable at December 31, 2019 | 2.86 | |
Weighted-average exercise price, Vested and expected to vest at December 31, 2019 | $ 7.65 | |
Weighted-average remaining contractual term, Outstanding | 8 years 9 months 25 days | 9 years 3 months |
Weighted-average remaining contractual term, Exercisable at December 31, 2019 | 8 years 2 months 12 days | |
Weighted-average remaining contractual term, Vested and expected to vest at December 31, 2019 | 8 years 9 months 25 days |
Stock-based compensation - Summ
Stock-based compensation - Summary of Restricted Stock Awards (RSA) Outstanding (Details) - Restricted Stock Awards (RSA) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of shares, Unvested as of December 31, 2018 | shares | 757,577 |
Number of shares, Vested/Released | shares | (378,789) |
Number of shares, Cancelled | shares | (6,631) |
Number of shares, Unvested as of December 31, 2019 | shares | 372,157 |
Grant-date fair value, Unvested as of December 31, 2018 | $ / shares | $ 2.84 |
Grant-date fair value, Vested/Released | $ / shares | 2.84 |
Grant-date fair value, Cancelled | $ / shares | 2.84 |
Grant-date fair value, Unvested as of December 31, 2019 | $ / shares | $ 2.84 |
Stock-based compensation - Sc_3
Stock-based compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 3,625 | $ 1,879 |
Research and Development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | 1,820 | 935 |
General and Administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 1,805 | $ 944 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense (benefit) | $ 0 | $ 0 |
Net operating loss carryforwards | 114,601 | |
Research and development tax credit carryforwards | 13,212 | |
Uncertain tax position | 0 | |
Accrued interest or penalties related to uncertain tax positions | 0 | 0 |
Amount of accrued interest or penalties recognized | 0 | 0 |
Unrecognized tax benefits | $ 0 | $ 0 |
Income Taxes - Summary of Curre
Income Taxes - Summary of Current and Deferred Tax Provision (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Deferred income tax benefit: | ||
Federal | $ (25,926,000) | $ (44,529,000) |
State | (5,807,000) | (12,350,000) |
Total deferred income tax benefit | (31,733,000) | (56,879,000) |
Change in deferred tax valuation allowance | (31,733,000) | (56,879,000) |
Total provision for income taxes | $ 0 | $ 0 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of U.S. Federal Statutory Income Tax Rate to Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
Permanent items | (0.50%) | (0.10%) |
State taxes, net of federal benefit (current) | 0.00% | 0.00% |
State taxes, net of federal benefit (deferred) | 6.70% | 6.50% |
Change in deferred tax asset valuation allowance | (36.70%) | (29.90%) |
Change in prior year credits | (0.30%) | 0.00% |
Current year credits generated | 9.80% | 2.50% |
Effective income tax rate | 0.00% | 0.00% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Stock compensation - NQSO | $ 185 | $ 67 |
Charitable contribution carryover | 38 | 5 |
Accrued bonus | 954 | 557 |
Accrued vacation | 127 | 31 |
Other accrued liabilities | 55 | |
Depreciation | 14 | 5 |
Capitalized acquired patents | 37,448 | 33,771 |
Capitalized start-up expenses | 5,156 | 2,167 |
Cumulative net operating loss | 31,536 | 15,833 |
R&E credit | 13,212 | 4,738 |
Total deferred tax assets | 88,670 | 57,229 |
Deferred tax liabilities: | ||
Stock Compensation - Restricted Shares | (58) | (350) |
Total deferred tax liabilities | (58) | (350) |
Total net deferred tax assets | 88,612 | 56,879 |
Less valuation allowance | $ (88,612) | $ (56,879) |
Benefit Plan - Additional Infor
Benefit Plan - Additional Information (Details) - 401(k) Plan - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Automatic matching contribution of employer ($1.00 per $1.00 of employee contribution) | 100.00% | |
Maximum contribution by employee, percentage | 4.00% | |
Company contributions to 401 (k) plan | $ 581 | $ 179 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Oct. 31, 2019 | Sep. 30, 2019 | Jul. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Loss Contingencies [Line Items] | |||||
Regulatory milestone payment | $ 19,800 | ||||
Additional regulatory expected payments | $ 20,000 | ||||
Operating lease effective date | Jul. 1, 2018 | ||||
Operating lease expiration date | 2021-06 | ||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||||
Operating lease, option to extend | option to extend it by one year | ||||
Operating lease term of extension | 1 year | ||||
Total lease payment under lease for remainder of fiscal year | $ 300 | ||||
Lease payment under lease for second year | 365 | ||||
Lease payment under lease for third year | 376 | ||||
Lease payment for remainder of lease | $ 191 | ||||
Rent expense | 344 | $ 170 | |||
Additional Office Space | |||||
Loss Contingencies [Line Items] | |||||
Operating lease effective date | Oct. 1, 2019 | ||||
Operating lease expiration date | 2021-06 | ||||
Total lease payment under lease for remainder of fiscal year | $ 101 | ||||
Lease payment under lease for second year | 407 | ||||
Lease payment for remainder of lease | $ 208 | ||||
Additional Lab Space | |||||
Loss Contingencies [Line Items] | |||||
Operating lease effective date | Oct. 15, 2019 | ||||
Operating lease expiration date | 2025-02 | ||||
Total lease payment under lease for remainder of fiscal year | $ 11 | ||||
Lease payment under lease for second year | 103 | ||||
Lease payment for remainder of lease | $ 573 | ||||
Lab Equipment | |||||
Loss Contingencies [Line Items] | |||||
Payments for non-cancelable lease agreement | $ 1,193 | ||||
Duration of non-cancelable lease agreement | 60 months | ||||
Research and Development | |||||
Loss Contingencies [Line Items] | |||||
Regulatory milestone payment | $ 19,800 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Related Party Transaction [Line Items] | ||
Related party liability | $ 12,892 | $ 12,054 |
AZ Parties | ||
Related Party Transaction [Line Items] | ||
Costs under agreements | 41,934 | 32,092 |
Related party liability | $ 12,892 | $ 12,054 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional Information (Details) - USD ($) $ in Thousands | Oct. 08, 2019 | May 24, 2019 | Jun. 30, 2019 | Dec. 31, 2019 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenues | $ 30,000 | $ 20,000 | $ 50,000 | ||||
Revenue from Contract with Customer, Product and Service [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | |||||
Commercial License And Collaboration Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Non-refundable upfront payments received | $ 15,000 | ||||||
Additional upfront non-refundable amount payment payable | 5,000 | $ 5,000 | |||||
Upfront payment | $ 30,000 | $ 20,000 | |||||
Revenues | 30,000 | $ 20,000 | |||||
Revenue from Contract with Customer, Product and Service [Extensible List] | us-gaap:LicenseMember | ||||||
Additional upfront non-refundable amount received | 5,000 | 5,000 | |||||
Upfront payment yet to be received | $ 30,000 | ||||||
Commercial License And Collaboration Agreement | Maximum | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Additional payments under agreement ability to receive | 203,000 | 203,000 | |||||
Commercial milestone payments | 180,000 | 180,000 | |||||
Development milestone payments | 5,000 | 5,000 | |||||
Commercial License And Collaboration Agreement | Minimum | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Development milestone payments | $ 2,000 | $ 2,000 |
Quarterly Financial Informati_3
Quarterly Financial Information (Unaudited) - Schedule of Quarterly Financial Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||
Revenues | $ 30,000 | $ 20,000 | $ 50,000 | |||||||
Loss from operations | (13,002) | $ (48,930) | (6,107) | $ (21,652) | $ (15,688) | $ (16,329) | $ (12,902) | $ (147,392) | (89,691) | $ (192,312) |
Net loss | $ (11,569) | $ (48,410) | $ (5,473) | $ (20,976) | $ (15,053) | $ (15,682) | $ (12,244) | $ (147,291) | $ (86,429) | $ (190,270) |
Net loss per share, basic and diluted | $ (0.24) | $ (64.59) | $ (8.94) | $ (167.38) | $ (1,505,319) | $ (1,568,200) | $ (1,224,372) | $ (14,729,074) | $ (7.02) | $ (19,027,000) |