Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 29, 2020 | Jun. 28, 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 | ||
Trading Symbol | ITRM | ||
Entity Registrant Name | Iterum Therapeutics plc | ||
Entity Central Index Key | 0001659323 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Ordinary Shares, $0.01 par value per share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-38503 | ||
Entity Incorporation, State or Country Code | L2 | ||
Entity Tax Identification Number | 98-1283148 | ||
Entity Address, Address Line One | Block 2 Floor 3 | ||
Entity Address, Address Line Two | Harcourt Centre | ||
Entity Address, Address Line Three | Harcourt Street | ||
Entity Address, City or Town | Dublin 2 | ||
Entity Address, Country | IE | ||
City Area Code | +353 | ||
Local Phone Number | 1 903-8920 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Common Stock, Shares Outstanding | 14,868,973 | ||
Entity Public Float | $ 36,871,186 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 4,801,000 | $ 44,551,000 |
Short-term investments | 0 | 40,000,000 |
Prepaid expenses and other current assets | 6,887,000 | 8,390,000 |
Current portion of restricted cash | 30,000 | 30,000 |
Total current assets | 11,718,000 | 92,971,000 |
Property and equipment, net | 572,000 | 700,000 |
Restricted cash, less current portion | 60,000 | 90,000 |
Other assets | 13,401,000 | 4,110,000 |
Total assets | 25,751,000 | 97,871,000 |
Current liabilities: | ||
Accounts payable | 15,486,000 | 4,041,000 |
Accrued expenses | 12,458,000 | 7,046,000 |
Current portion of long-term debt | 5,800,000 | 1,019,000 |
Other current liabilities | 3,042,000 | |
Income taxes payable | 200,000 | 113,000 |
Total current liabilities | 36,986,000 | 12,219,000 |
Long-term debt, less current portion | 7,625,000 | 13,079,000 |
Other liabilities | 7,378,000 | 951,000 |
Total liabilities | 51,989,000 | 26,249,000 |
Commitments and contingencies (Note 12) | ||
Shareholders’ (deficit) / equity: | ||
Ordinary shares, $0.01 par value per share: 50,000,000 shares authorized, 14,868,973 shares issued at December 31, 2019; 50,000,000 shares authorized, 14,352,046 shares issued at December 31, 2018 | 149,000 | 144,000 |
Additional paid-in capital | 208,536,000 | 203,271,000 |
Accumulated deficit | (234,923,000) | (131,793,000) |
Total shareholders' (deficit) / equity | (26,238,000) | 71,622,000 |
Total liabilities and shareholders’ (deficit) / equity | $ 25,751,000 | $ 97,871,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 | May 30, 2018 | Mar. 13, 2018 | Mar. 12, 2018 | Feb. 16, 2018 | May 18, 2017 | Nov. 18, 2015 | Oct. 14, 2015 |
Statement Of Financial Position [Abstract] | |||||||||
Ordinary shares, par value | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.001 | $ 0.0001 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | 44,557,606 | 44,557,606 | 7,956,715 | 3,659,453 | 413,110 | |
Ordinary shares, shares issued | 14,868,973 | 14,352,046 | 413,110 | 413,110 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | |||
Revenue | $ 37 | $ 869 | $ 508 |
Operating expenses: | |||
Research and development | (90,774) | (68,647) | (25,499) |
General and administrative | (11,284) | (8,781) | (4,464) |
Total operating expenses | (102,058) | (77,428) | (29,963) |
Operating loss | (102,021) | (76,559) | (29,455) |
Interest (expense) / income, net | (861) | (426) | 277 |
Other income, net | 196 | 401 | 216 |
Total other (expense) / income | (665) | (25) | 493 |
Loss before income taxes | (102,686) | (76,584) | (28,962) |
Income tax expense | (444) | (472) | (444) |
Net loss and comprehensive loss | (103,130) | (77,056) | (29,406) |
Net loss attributable to ordinary shareholders | $ (103,130) | $ (77,056) | $ (29,406) |
Net loss per share attributable to ordinary shareholders – basic and diluted | $ (7.10) | $ (8.82) | $ (170.84) |
Weighted average ordinary shares outstanding – basic and diluted | 14,518,036 | 8,734,109 | 172,130 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Shares and Shareholders' (Deficit) / Equity - USD ($) $ in Thousands | Total | Convertible Preferred Stock | Series B Convertible Preferred Shares | IPO | Ordinary Shares | Ordinary SharesConvertible Preferred Stock | Ordinary SharesIPO | Additional Paid-In Capital | Additional Paid-In CapitalIPO | Accumulated Deficit |
Beginning balance at Dec. 31, 2016 | $ 22,668 | $ 4 | $ 47,995 | $ (25,331) | ||||||
Temporary Equity beginning balance (in shares) at Dec. 31, 2016 | 3,032,457 | |||||||||
Temporary Equity beginning balance at Dec. 31, 2016 | $ 30 | |||||||||
Beginning balance (in shares) at Dec. 31, 2016 | 413,110 | |||||||||
Issuance of Series B convertible preferred shares, net of issuance costs | 45,840 | 45,840 | ||||||||
Temporary equity,Issuance of shares (in shares) | 2,654,206 | |||||||||
Temporary equity,Issuance of shares | $ 27 | |||||||||
Share-based compensation expense | 392 | 392 | ||||||||
Net loss | (29,406) | (29,406) | ||||||||
Ending balance at Dec. 31, 2017 | 39,494 | $ 4 | 94,227 | (54,737) | ||||||
Temporary Equity ending balance (in shares) at Dec. 31, 2017 | 5,686,663 | |||||||||
Temporary Equity ending balance at Dec. 31, 2017 | $ 57 | |||||||||
Ending balance (in shares) at Dec. 31, 2017 | 413,110 | |||||||||
Issuance of Series B convertible preferred shares, net of issuance costs | 32,159 | 32,159 | ||||||||
Temporary equity,Issuance of shares (in shares) | 1,709,650 | |||||||||
Temporary equity,Issuance of shares | $ 17 | |||||||||
Issuance of shares | $ 74,153 | $ 64 | $ 74,089 | |||||||
Issuance of shares (in shares) | 6,350,000 | |||||||||
Exercise of share options | $ 7 | 7 | ||||||||
Exercise of share options (in shares) | 2,008 | 2,008 | ||||||||
Issuance of ordinary shares under subscription agreement | $ 1,362 | $ 2 | 1,360 | |||||||
Issuance of ordinary shares under subscription agreement (in shares) | 190,615 | |||||||||
Redenomination of share capital | (42) | $ (42) | ||||||||
Temporary equity,redenomination of share capital | $ 42 | |||||||||
Conversion of preferred shares to ordinary shares | 116 | $ 116 | ||||||||
Temporary equity conversion of convertible preferred stock (in shares) | (7,396,313) | |||||||||
Temporary equity conversion of convertible preferred stock | $ (116) | |||||||||
Conversion of preferred shares to ordinary shares (in shares) | 7,396,313 | |||||||||
Issuance of warrants for ordinary shares | 139 | 139 | ||||||||
Share-based compensation expense | 1,290 | 1,290 | ||||||||
Net loss | (77,056) | (77,056) | ||||||||
Ending balance at Dec. 31, 2018 | 71,622 | $ 144 | 203,271 | (131,793) | ||||||
Ending balance (in shares) at Dec. 31, 2018 | 14,352,046 | |||||||||
Issuance of ordinary shares in conjunction with vesting of restricted share units (in shares) | 36,924 | |||||||||
Exercise of share options | $ 60 | 60 | ||||||||
Exercise of share options (in shares) | 18,232 | 18,232 | ||||||||
Issuance of ordinary shares under subscription agreement | $ 3,037 | $ 5 | 3,032 | |||||||
Issuance of ordinary shares under subscription agreement (in shares) | 461,771 | |||||||||
Share-based compensation expense | 2,173 | 2,173 | ||||||||
Net loss | (103,130) | (103,130) | ||||||||
Ending balance at Dec. 31, 2019 | $ (26,238) | $ 149 | $ 208,536 | $ (234,923) | ||||||
Ending balance (in shares) at Dec. 31, 2019 | 14,868,973 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | |||
Net loss | $ (103,130) | $ (77,056) | $ (29,406) |
Adjustments to reconcile net loss to cash used in operating activities: | |||
Depreciation | 152 | 136 | 65 |
Share-based compensation expense | 2,173 | 1,290 | 392 |
Gain on short term investments | (125) | (423) | |
Non-cash (gain) / loss on short term investments | (278) | 44 | |
Interest on short-term investments | (5) | (40) | (95) |
Amortization of debt discount and deferred financing costs | 362 | 360 | |
Issuance of ordinary shares under subscription agreement | 3,037 | 1,362 | |
Other | 752 | 362 | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | 2,471 | (3,613) | (3,815) |
Other assets | (1,166) | (2,273) | (782) |
Accounts payable | 11,446 | 849 | 1,671 |
Accrued expenses | 5,851 | 3,072 | 1,236 |
Income taxes | 123 | 120 | 6 |
Other liabilities | (826) | 242 | 80 |
Net cash used in operating activities | (78,885) | (75,890) | (30,604) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (24) | (90) | (812) |
Purchases of short-term investments | (96,493) | (53,275) | |
Proceeds from sale of short-term investments | 40,125 | 87,925 | 22,500 |
Net cash provided by / (used in) investing activities | 40,101 | (8,658) | (31,587) |
Cash flows from financing activities: | |||
Proceeds from issuance of debt, net of debt issuance costs | 14,507 | ||
Repayments of long-term debt | (1,034) | ||
Proceeds from issuance of ordinary shares on initial public offering, net of issuance costs | 74,153 | ||
Proceeds from exercise of share options | 60 | 7 | |
Net cash (used in) / provided by financing activities | (974) | 120,842 | 45,867 |
Effect of exchange rates on cash and cash equivalents | (22) | (108) | |
Net (decrease) / increase in cash, cash equivalents and restricted cash | (39,780) | 36,186 | (16,324) |
Cash, cash equivalents and restricted cash, at beginning of period | 44,671 | 8,485 | 24,809 |
Cash, cash equivalents and restricted cash, at end of period | 4,891 | 44,671 | 8,485 |
Supplemental Disclosure of Cash Flow Information: | |||
Income tax paid—U.S. | 414 | 352 | 439 |
Interest paid | $ 1,399 | 809 | |
Series B Convertible Preferred Shares | |||
Cash flows from financing activities: | |||
Proceeds from issuance of convertible preferred shares | $ 32,175 | $ 45,867 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Operations and Basis of Presentation | (1) Iterum Therapeutics plc (the “Company”) was incorporated under the laws of the Republic of Ireland in June 2015 as a limited company and re-registered as a public limited company on March 20, 2018. The Company maintains its registered office at Block 2 Floor 3, Harcourt Centre, Harcourt Street, Dublin 2, Ireland. The Company commenced operations in November 2015. The Company licensed global rights to its novel anti-infective compound, sulopenem, from Pfizer Inc. (“Pfizer”). The Company is a clinical-stage pharmaceutical company dedicated to developing and commercializing sulopenem to be potentially the first and only oral and intravenous (“IV”) branded penem available globally. Since inception, the Company has devoted substantially all of its efforts to research and development, recruiting management and technical staff, and raising capital, and has financed its operations through the issuance of ordinary and convertible preferred shares, debt raised under a financing arrangement with Silicon Valley Bank (“SVB”), a sub-award from the Trustees of Boston University under the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (“CARB-X”) program and the proceeds of a private placement pursuant to which its wholly owned subsidiary, Iterum Therapeutics Bermuda Limited (“Iterum Bermuda”) issued and sold approximately $51.6 million aggregate principal amount of 6.500 and $0.1 million aggregate principal amount of Limited Recourse Royalty-Linked Subordinated Notes (the “RLNs” and, together with the Exchangeable Notes, the “Securities”) to a group of accredited investors . The Company has not generated any product revenue. The Company is subject to risks and uncertainties common to early-stage companies in the pharmaceutical industry, including, but not limited to, the ability to secure additional capital to fund operations, failure to successfully develop and commercialize its product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology and compliance with government regulations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company and its subsidiaries. On May 15, 2018, the Company’s shareholders approved a consolidation of its ordinary shares and convertible preferred shares at a 1-for-15.71 ratio (the “Reverse Share Split”), effective on that date. Fractional entitlements to ordinary shares and convertible preferred shares arising as a result of the Reverse Share Split were rounded down to the nearest whole number for each holder of ordinary shares and convertible preferred shares. Those fractional entitlements were aggregated and surrendered to the Company for cancellation. Immediately following the Reverse Share Split, the Company redenominated its ordinary shares and convertible preferred shares from $0.01571 (the nominal value resulting from the Reverse Share Split) per share to $0.01 per share (the “Renominalisation”). All issued and outstanding ordinary shares, convertible preferred shares, options for ordinary shares, restricted share awards, warrants and per share amounts have been retroactively adjusted to reflect this Reverse Share Split and Renominalisation for all periods presented. On May 30, 2018, the Company completed an initial public offering (“IPO”) of its ordinary shares, and issued and sold 6,150,000 ordinary shares at a public offering price of $13.00 per share, resulting in net proceeds of $71.8 million after deducting underwriting discounts and commissions and offering costs payable by the Company. On June 26, 2018, the Company issued and sold an additional 200,000 ordinary shares at the IPO price of $13.00 per share pursuant to the underwriters’ partial exercise of their option to purchase additional ordinary shares, resulting in additional net proceeds of $2.4 million after deducting underwriting discounts and commissions and offering costs payable by the Company. Aggregate net proceeds from the IPO totaled $74.2 million after deducting underwriting discounts and commissions and offering costs payable by the Company. On July 5, 2019, the Company filed a universal shelf registration statement on Form S-3 (Registration No. 333-232569) with the Securities and Exchange Commission (“SEC”), which was declared effective on July 16, 2019, and pursuant to which it registered for sale up to $150.0 million of any combination of its ordinary shares, preferred shares, debt securities, warrants and/or units from time to time and at prices and on terms that the Company may determine. On January 21, 2020, the Company completed a private placement pursuant to which its wholly owned subsidiary, Iterum Bermuda, issued and sold approximately $51.6 million aggregate principal amount of Exchangeable Notes RLNs In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) The Company has funded its operations to date primarily with proceeds from the sale of preferred shares and ordinary shares, debt raised under its financing arrangement with SVB, payments received under the CARB-X program and the proceed of a private placement of Exchangeable Notes and RLNs. The Company has incurred operating losses since inception, including net losses of $103,130, $77,056 and $29,406 for the years ended December 31, 2019, 2018 and 2017, respectively. The Company had an accumulated deficit of $234,923 as of December 31, 2019 and expects to continue to incur net losses for the foreseeable future. The Company’s future cash flows are dependent on key variables such as its ability to secure additional sources of funding in the form of public or private financing of debt or equity or collaboration agreements. The Company may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company's shareholders. If the Company is unable to obtain funding, it could be forced to delay, reduce or eliminate some or all of its research and development programs or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, and the Company has successfully raised capital in the past, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. Based on the Company’s operating losses since inception, the expectation of continued operating losses for the foreseeable future, and the need to raise additional capital to finance its future operations, management have concluded there is substantial doubt about the Company’s ability to continue as a going concern within one year from the date these consolidated financial statements are issued. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (2) Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, the valuation of restricted ordinary shares and the valuation of share-based compensation awards. 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 as there are changes in circumstances, facts and experience. Actual results could differ materially from those estimates. Comprehensive Loss Comprehensive Loss includes net loss as well as other changes in shareholders’ (deficit) / equity that result from transactions and economic events other than those with shareholders. For the periods presented in the accompanying consolidated financial statements, there was no difference between net loss and comprehensive loss. Consolidation The accompanying consolidated financial statements include the accounts of Iterum Therapeutics plc and its wholly owned subsidiaries (which are referred to herein, collectively, as the “Company” where context requires). All significant intercompany balances and transactions have been eliminated on consolidation. The Company has no involvement with variable interest entities. Short-term Investments The Company classifies short-term investments as available for sale in accordance with the terms of Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 320, Investments – Debt and Equity Securities Cash and Cash Equivalents The Company’s cash and cash equivalents consist of cash balances and highly liquid investments with maturities of three months or less at the date of purchase. Accounts held at U.S. financial institutions are insured by the FDIC up to $250, while accounts held at Irish financial institutions are insured under the Deposit Guarantee Scheme up to $112 (€100). Cash accounts with any type of restriction are classified as restricted cash. If restrictions are expected to be lifted in the next twelve months, the restricted cash account is classified as current. Included within restricted cash on the Company’s consolidated balance sheet is a certificate of deposit for $90 which is being held by a third party bank as collateral for the irrevocable letter of credit issued in March 2018 to secure an office lease (see Note 12, Commitments and Contingencies). Foreign Currencies Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the entity operates (functional currency). The consolidated financial statements are presented in U.S. dollars. Transactions in foreign currencies are recorded at the rate of exchange at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies at the balance sheet date are retranslated into the functional currency at the rate of exchange at the balance sheet date, and the resulting gains and losses are recognized in the consolidated statement of operations and comprehensive loss. Non-monetary items in a foreign currency that are measured in terms of historical cost are translated using the exchange rate at the date of transaction. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Leasehold improvements Shorter of life of lease or 10 years Furniture and fixtures 5 years Laboratory equipment 5 years Computer equipment 3 years Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Repairs and maintenance costs are expensed as incurred. The Company reviews the recoverability of all long-lived assets, including the related useful life, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. Leases The Company determines if an arrangement contains a lease at inception. For arrangements that contain a lease, lease classification, recognition, and measurement are determined at the lease commencement date. The Company has elected to separately account for lease and non-lease components in determining the lease liabilities and right-of-use assets. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The Company’s lease agreements generally do not provide an implicit borrowing rate, therefore the Company uses its incremental borrowing rate at lease commencement to determine the present value of lease payments. The incremental borrowing rate is an entity-specific rate which represents the rate of interest a lessee would pay to borrow on a collateralized basis over a similar term with similar payments. All operating lease expenses are recognized on a straight-line basis over the lease term. Research and Development Expenses The Company expenses the cost of research and development as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including salaries, share-based compensation and benefits, facilities costs, depreciation, manufacturing expenses and external costs of third-parties engaged to supply active pharmaceutical ingredient and drug product and conduct preclinical and clinical development activities and trials, as well as the cost of licensing technology, license fees, and other external costs. Advance payments for goods and services that will be used in future research and development activities are recorded as prepaid expenses and expensed when the activity is performed or when the goods have been received. Accrued Research and Development Expenses The Company has entered into various research and development contracts with research institutions and other companies. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. This process involves reviewing open contracts and purchase orders, communicating with Company personnel to identify services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advanced payments. The Company estimates accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known at that time. It periodically confirms the accuracy of these estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to: • Vendors, including central laboratories, in connection with preclinical development activities; • Clinical Research Organizations, or CROs, and investigative sites in connection with preclinical studies and clinical trials; and • Contract Manufacturing Organizations, or CMOs, in connection with drug substance and drug product formulation of preclinical and clinical trial materials. The Company bases expenses related to preclinical studies and clinical trials on estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions and CROs that conduct and manage preclinical studies and clinical trials on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the accrual or the amount of prepaid expenses is adjusted accordingly. Although the Company does not expect the estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to prior estimates of accrued research and development expenses. 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. Share-Based Compensation The Company measures share-based awards granted to employees and directors with service based vesting conditions only based on the fair value on the date of grant using the Black-Scholes option-pricing model. Compensation expense of those awards is recognized over the requisite service period, which is generally the vesting period of the respective award, using the straight-line method. The Company measures share-based awards granted to employees and directors with both performance and service based vesting conditions based on the fair value on the date of grant using the Monte Carlo simulation model. Compensation expense of those awards is recognized over the determined vesting period, the period over which all the specified vesting conditions are to be satisfied, using the straight-line method. For awards granted to consultants and non-employees, compensation expense is recognized over the period during which services are rendered until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the Company’s ordinary shares and updated assumption inputs in the Black-Scholes option-pricing model or the Monte Carlo simulation model. The Company classifies share-based compensation expense in the consolidated 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. The Black-Scholes option-pricing model uses key inputs and assumptions including the expected term of the option, share price volatility, risk-free interest rate, dividend yield, share price and exercise price which is equivalent to closing market value on the date of grant. Many of the assumptions require significant judgment and any changes could have a material impact in the determination of share-based compensation expense. The Monte Carlo simulation model uses key inputs and assumptions including share price volatility, risk-free interest rate, the expected date of satisfaction of vesting conditions and share price. Many of the assumptions require significant judgment and any changes could have a material impact in the determination of share-based compensation expense. The Company has elected to account for forfeitures as they occur. Grant Awards The Company may generate revenue from grant awards that reimburse certain allowable costs for specified projects. For contracts with third parties, when the Company has concluded that it is the principal in conducting the research and development, and where the funding arrangement is considered central to the Company’s ongoing operations, it classifies the recognized funding received as revenue. In June 2017, the Company was granted the CARB-X award in the amount of $1.5 million. The CARB-X award was structured as a cost reimbursement arrangement and was recognized over a period of 20 months from August 2017 to March 2019. The Company recognized the CARB-X award as revenue, rather than as a reduction of research and development expenses, because the Company was the principal in conducting the research and development activities and this contract was central to its ongoing operations. Revenue was recognized as the qualifying expenses related to the contract were incurred. Five steps are applied in the revenue recognition process: (1) identify the contract with a customer; (2) identify the performance obligation in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies the performance obligation. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded in the Company’s consolidated balance sheet as other prepaid assets. The related costs incurred by the Company were included in research and development expenses in the Company’s consolidated statements of operations and comprehensive loss. The Company recognized $37, $869 and $508 as revenue for the years ended December 31, 2019, 2018 and 2017, respectively, in respect of the CARB-X award. Research and Development Credits Research and development credits are available to the Company under the tax laws in both Ireland and the U.S., based on qualifying research and development spend in each jurisdiction as defined under those tax laws. Research and development credits are generally recognized as a reduction of research and development expenses. Fair Value of Financial Instruments FASB guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: • Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. • Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g. quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. • Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. The Company’s short-term investments and its advance payments to a supplier are carried at fair value, determined according to the fair value hierarchy above, see Note 3 for further details. The carrying amounts reported in the consolidated balance sheets for prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair value based on the short-term maturity of these instruments. Borrowings Interest bearing long-term debt is recognized initially at fair value, net of transactions costs incurred. Subsequent to initial recognition, interest bearing long-term debt is measured at amortized cost with any difference between cost and redemption value being recognized as a non-cash component of interest expense in the income statement over the period of the borrowings on an effective interest basis. Concentration of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company has most of its cash and cash equivalents at two accredited financial institutions in the United States, in amounts that exceed federally insured limits. The Company did not hold any short-term investments as of December 31, 2019. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Income Taxes The Company accounts for income taxes under the asset and liability method which requires deferred tax assets and liabilities to be recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as net operating loss carryforwards and research and development tax credits. Valuation allowances are provided if it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that has a greater than 50% likelihood of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest related to unrecognized tax benefits in interest expense and penalties in general and administrative expenses. On December 22, 2017, the United States federal government enacted the Tax Act, marking a change from a worldwide tax system to a modified territorial tax system in the United States. As part of this change, the Tax Act, among other changes, provided a reduction of the U.S. federal corporate income tax rate from 34% to 21%, an indefinite carryforward of net operating losses incurred in 2018 and future periods, and an interest limitation starting in 2018 with an indefinite carryforward. Any impact to the Company related to these items was accounted for in the 2017, 2018 and 2019 tax provisions with minimal impact. Net Loss Per Ordinary Share Basic and diluted net loss per ordinary share is determined by dividing net loss attributable to ordinary shareholders by the weighted-average ordinary shares outstanding during the period; in accordance with ASC 260, Earnings per Share The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as they would be anti-dilutive: Year ended December 31, 2019 2018 2017 Options to purchase ordinary shares 1,150,270 665,219 248,128 Preferred shares convertible into ordinary shares — — 5,686,663 Unvested restricted ordinary shares — 86,068 189,342 Unvested restricted share units 31,367 36,924 — Unvested performance restricted share units 50,000 — — Warrants 19,890 19,890 — Total 1,251,527 808,101 6,124,133 The weighted-average shares outstanding used to calculate both basic and diluted loss per ordinary share are the same. Segment and Other Information The Company determines and presents operating segments based on the information that is internally provided to the Chief Executive Officer, Chief Scientific Officer and Chief Financial Officer, who together are considered the Company’s chief operating decision maker, in accordance with ASC 280, Segment Reporting The distribution of total operating expenses by geographical area was as follows: Year ended December 31, Operating expenses 2019 2018 2017 Ireland $ 90,792 $ 66,552 $ 24,619 U.S. 11,266 10,876 5,344 Total $ 102,058 $ 77,428 $ 29,963 The distribution of long-lived assets by geographical area was as follows: Long lived assets December 31, 2019 December 31, 2018 Ireland $ 10,936 $ 4,565 U.S. 3,037 245 Total $ 13,973 $ 4,810 Retirement Plan The Company has a defined contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all U.S. employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pre-tax basis. If the 401(k) Plan is considered top-heavy at the end of the financial year, with key employee accounts accounting for >60% of total 401(k) Plan assets, the Company is required to contribute a deferral rate of up to 3% to the 401(k) Plan on behalf of certain employees. The Company was not required to make a top-heavy contribution for the year ended December 31, 2019. The Company made contributions of $114 and $33 for the years ended December 31, 2018 and 2017, respectively. Inventory Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. The Company’s policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on the estimates of future demand for a particular product. If the estimate of future demand changes, the Company considers the impact on the reserve for excess inventory and adjusts the reserve as required. Increases in the reserve are recorded as charges in cost of product sales. For product candidates that have not been approved by the FDA, inventory used in clinical trials is expensed at the time of production and recorded as research and development expenses. For products that have been approved by the FDA, inventory used in clinical trials is expensed at the time the inventory is packaged for the clinical trial. Prior to an advisory committee providing a recommendation to the FDA that the Company’s application should be approved, costs related to manufacturing the product candidates are recorded as research and development expenses. All direct manufacturing costs incurred after this recommendation will be capitalized into inventory. The Company had no inventory as of December 31, 2019 or December 31, 2018. Contingent Consideration Certain license agreements contain milestone payments that could result in the requirement to make contingent consideration payments, see Note 12 for further details. Contingent consideration is recorded at the acquisition date estimated fair value of the contingent payment. The fair value of the contingent consideration is measured at each reporting period. Any related unwinding of discount is recognized as a finance expense. Other changes in fair value are recognized in profit or loss or capitalized as an intangible asset depending on the stage of development. As of December 31, 2019, no milestones had been met that required the Company to recognize contingent consideration. Recently Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (FASB) issued ASU 2016-02, Leases Leases Targeted Improvements Leases Codification Improvements ASU 2016-02 requires a lessee to recognize a liability to make lease payments (the lease liability) and a right-of-use asset, representing its right to use the underlying asset for the lease term, on the balance sheet. The Company adopted ASU 2016-02 in the first quarter of 2019 utilizing the modified retrospective transition method with an effective date as the date of initial application. Consequently, prior period balances and disclosures have not been restated. The adoption of ASU 2016-02 on January 1, 2019 resulted in the recognition of right-of-use assets of $7.6 million and operating lease liabilities of $7.8 million, however, the adoption of the standard did not have an impact on the Company’s beginning retained earnings, results from operations or cash flows. See Note 7 for further information regarding the impact of the adoption of ASU 2016-02 on the Company's consolidated financial statements. In July 2017, the FASB issued ASU 2017-11, Earnings Per Share Distinguishing Liabilities from Equity Derivatives and Hedging Part I applies to entities that issue financial instruments such as warrants, convertible debt or convertible preferred shares that contain down-round features. Part II replaces the indefinite deferral for certain mandatorily redeemable noncontrolling interests and mandatorily redeemable financial instruments of nonpublic entities contained within ASC Topic 480 with a scope exception and does not impact the accounting for these mandatorily redeemable instruments. ASU 2017-11 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of ASU 2017-11 did not have an impact on the Company’s consolidated financial statements. In June 2018, the FASB issued ASU 2018-07, Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting ASU 2018-07 expands the scope of Topic 718 to include all share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 specifies that Topic 718 applies to all share-based payment transactions in which the grantor acquires goods and services to be used or consumed in its own operations by issuing share-based payment awards. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under ASC 606. ASU 2018-07 is required to be adopted for annual periods beginning after December 15, 2019, including interim periods within those fiscal years. The adoption of ASU 2018-07 did not have an impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements There are no recently issued accounting pronouncements that will have a material impact on the Company’s consolidated financial statements and related disclosures. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | (3) Fair Value of Financial Assets and Liabilities The following table presents information about the Company’s financial assets that were carried at fair value on a recurring basis on the consolidated balance sheet as of December 31, 2019 and December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value. December 31, 2019 Assets Total Level 1 Level 2 Level 3 Other assets – advance payment to supplier 3,884 — — 3,884 December 31, 2018 Assets Total Level 1 Level 2 Level 3 Short-term investments $ 40,000 40,000 — — Other assets – advance payment to supplier 2,649 — — 2,649 Total $ 42,649 40,000 — 2,649 See Note 4 for further details on short-term investments. The other asset above relates to advance payments made to a supplier that were recorded at fair value using the discounted cash flow model, or DCF, as of December 31, 2019 and December 31, 2018. The fair value measurements of these advance payments were determined based on significant unobservable inputs, including a discount rate of 15% and the expected time to recovery of the payment. Changes to the inputs described above are not expected to have a material impact on the company’s financial position and results of operations in any given period. See Note 12 — Payments to Supplier , The following table presents information about the Company’s long-term debt which was carried at amortized cost on the consolidated balance sheet as of December 31, 2019 and December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine the approximate fair value. December 31, 2019 Liabilities Book Value Approximate Fair Value Level 1 Level 2 Level 3 Current portion of long-term debt $ 5,800 $ 5,800 — 5,800 — Long-term debt, less current portion 7,625 7,213 — 7,213 — Total $ 13,425 $ 13,013 — 13,013 — December 31, 2018 Liabilities Book Value Approximate Fair Value Level 1 Level 2 Level 3 Current portion of long-term debt $ 1,019 $ 1,019 — 1,019 — Long-term debt, less current portion 13,079 13,035 — 13,035 — Total $ 14,098 $ 14,054 — 14,054 — The book value of the current portion of long-term debt approximates its fair value due to the short-term nature of the balance. The fair value of long-term debt, less current portion was determined based on a DCF analysis using quoted market interest rates, without consideration of transaction costs, which represents a Level 2 basis of fair value measurement. The counterparty to the long-term debt is a major international financial institution. The carrying amounts reported in the consolidated balance sheets for prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximate their fair value based on the short-term maturity of these instruments. There have been no transfers of assets or liabilities between the fair value measurement levels. |
Short Term Investments
Short Term Investments | 12 Months Ended |
Dec. 31, 2019 | |
Available For Sale Securities [Abstract] | |
Short Term Investments | (4) Short-term Investments The Company classifies its short-term investments as available for sale. Short-term investments comprise highly liquid investments with minimum “A-” rated securities. Investments are reported at fair value with unrealized gains or losses recorded in the consolidated statements of operations and comprehensive loss. Any differences between the cost and fair value of investments are represented by unrealized gains or losses. The fair values of short-term investments are represented by Level 1 fair value measurements – quoted prices in active markets for identical assets. The Company did not hold any short-term investments as of December 31, 2019. The following table represents the Company’s available for sale short-term investments by major security type as of December 31, 2018: December 31, 2018 Maturity by period Unrealized Unrealized Fair Value Less than 1 Available for sale Cost Total gains (losses) Total year 1 to 5 years Commercial paper $ 35,745 272 (9 ) 36,008 36,008 — U.S. Treasury and Agency Bonds 3,977 15 — 3,992 3,992 — Total $ 39,722 287 (9 ) 40,000 40,000 — |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2019 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Prepaid Expenses and Other Current Assets | (5) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: December 31, 2019 December 31, 2018 Deferred financing expenses (1) $ 2,339 — Prepaid research and development expenses 1,679 5,351 Short-term deposits 1,139 959 Research and development tax credit receivable 1,036 404 Prepaid insurance 569 438 Value added tax receivable 68 159 Other prepaid assets 50 921 Interest receivable 7 158 Total $ 6,887 $ 8,390 (1) See note 15 to the consolidated financial statements for further details deferred financing expenses. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | (6) Property and Equipment, net Property and equipment and related accumulated depreciation are as follows: December 31, 2019 December 31, 2018 Leasehold improvements $ 592 $ 592 Furniture and fixtures 120 120 Laboratory equipment 81 81 Computer equipment 132 108 925 901 Less: accumulated depreciation (353 ) (201 ) $ 572 $ 700 Depreciation expense was $152, $136 and $65 for the years ended December 31, 2019, 2018 and 2017, respectively. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | (7) Leases The Company has entered into a number of operating leases, primarily for office space and commercial property. These leases have terms which range from four to 19 years, and generally include one or more options to terminate or renew. The termination options can reduce the lease term for periods ranging from five to 10 years, however the remaining lease terms do not represent these early termination dates as management has concluded that it is reasonably certain that the Company will not exercise these options. The renewal terms can extend the lease term for additional periods ranging from three to five years. These renewal options are represented in the remaining lease term as management has concluded that it is reasonably certain that the Company will exercise the renewal option. Certain leases contain variable lease payments, including payments based on an index or rate. Variable lease payments based on an index or rate are initially measured using the index or rate in effect at lease commencement. Certain agreements contain both lease and non-lease components. The Company has elected to separately account for these components in determining the lease liabilities and right-of-use assets. The Company’s lease agreements generally do not provide an implicit borrowing rate, therefore an internal incremental borrowing rate was determined based on information available at lease commencement date for the purposes of determining the present value of lease payments. The Company used the incremental borrowing rate on January 1, 2019 for all leases that commenced prior to that date. All operating lease expenses are recognized on a straight-line basis over the lease term. The Company recognized $1,015 of operating lease costs for right-of-use assets during the year ended December 31, 2019. Information related to the Company’s right-of-use assets and related lease liabilities is as follows: Year Ended December 31, 2019 Cash paid for operating lease liabilities $ 826 Right-of-use assets obtained in exchange for new operating lease obligation (1) 7,622 (1) All operating lease included above were held at January 01, 2019. December 31, 2019 Weighted-average remaining lease term 12.5 years Weighted-average discount rate 7.6% Right-of-use assets and lease liabilities for the Company’s operating leases were recorded in the consolidated balance sheet as follows, representing the Company’s right to use the underlying asset for the lease term (“Other assets”) and the Company’s obligation to make lease payments (“Other current liabilities” and “Other liabilities”): December 31, 2019 Other assets $7,144 Other current liabilities $580 Other liabilities 6,748 Total lease liabilities $7,328 The Company has recorded the reduction in carrying amount of the right-of-use assets and the change in the lease liability in the Other category within the operating section of the consolidated statement of cash flows. Future lease payments included in the measurement of lease liabilities on the consolidated balance sheet as of December 31, 2019 for the following five fiscal years and thereafter were as follows: Due in 12 month period ended December 31, 2020 $1,099 2021 1,023 2022 1,032 2023 1,038 2024 1,042 Thereafter 5,641 $10,875 Less imputed interest (3,547) Total lease liabilities $7,328 As of December 31, 2018, future minimum lease payments, as defined under the previous lease accounting guidance of ASC Topic 840, under non-cancelable operating leases for the following five fiscal years and thereafter were as follows: Due in 12 month period ended December 31, 2019 $904 2020 1,020 2021 1,030 2022 985 2023 766 Thereafter 2,356 $7,061 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | ( 8 ) Accrued Expenses Accrued expenses consist of the following: December 31, 2019 December 31, 2018 Accrued clinical trial costs $ 9,866 $ 2,849 Accrued payroll and bonus expenses 1,207 1,804 Accrued manufacturing expenses 136 1,439 Accrued other expenses 1,249 954 Total $ 12,458 $ 7,046 |
Shareholders' (Deficit) _ Equit
Shareholders' (Deficit) / Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Shareholders' (Deficit) / Equity | ( 9 ) Shareholders’ (Deficit) / Equity The Company’s capital structure consists of ordinary shares, undesignated preferred shares and, prior to the completion of the Company’s IPO on May 30, 2018, convertible preferred shares with certain rights and privileges summarized below. Under Irish law, the Company is prohibited from allotting shares without consideration. Accordingly, at least the nominal value of the shares issued underlying any restricted share award, restricted share unit, performance share award, bonus share or any other share based grant must be paid pursuant to the Irish Companies Act 2014 ( “ ” Ordinary Shares The Company was initially incorporated without a cap on its authorized share capital as permitted by the Irish Companies Act. On October 14, 2015, the Company authorized and issued 413,110 ordinary shares with a par value of $0.01 per share (after taking account of the reverse share split and redenomination of the par value of the ordinary shares from $0.01571 (the nominal value resulting from the reverse share split) to $0.01 on May 15, 2018). On March 13, 2018, the Company redenominated its 44,557,606 authorized and 413,110 issued ordinary shares from $0.0001 to $0.001 per share in accordance with section 83(1)(c) of the Irish Companies Act. On November 18, 2015, the Company increased the authorized ordinary share capital to 3,659,453 shares with a par value of $0.01 per share. On May 18, 2017, the Company increased the authorized ordinary share capital to 7,956,715 shares with a par value of $0.01 per share. On February 16, 2018, the Company increased its authorized ordinary shares by 36,600,891 to 44,557,606 ordinary shares with a par value of $0.01 per share. On May 30, 2018, the Company increased its authorized ordinary shares by 5,442,394 to 50,000,000 ordinary shares of $0.01 each. On December 14, 2018, Iterum Therapeutics plc (“ITP”) and Iterum Therapeutics International Limited (“ITIL”) entered into a subscription agreement with a supplier of ITIL pursuant to which the supplier agreed to subscribe for ordinary shares in ITP in satisfaction of amounts due and owing under certain commercial agreements entered into between the supplier and ITIL (the “Subscription Agreement”). Pursuant to the terms of the Subscription Agreement, upon receipt by ITIL of a valid invoice from the supplier, ITP can elect to require the supplier to subscribe for ordinary shares in the capital of ITP (up to a maximum of 700,000 ordinary shares in total) to the value of the invoiced amount (a “Subscription”). On a Subscription, the supplier will direct ITIL to pay ITP such invoiced amount as subscription monies on the supplier’s behalf in satisfaction of the invoiced amount. On December 14, 2018, ITP elected that the supplier subscribe for 190,615 ordinary shares for an aggregate subscription price of $1.36 million (the “December Subscription Monies”) upon receipt by ITIL of valid invoices up to that amount from the supplier (the “Invoiced Amount”). On that date, ITP, ITIL and the supplier executed a payment direction letter pursuant to which the parties directed ITIL to pay $1.36 million (€1.20 million) to ITP in satisfaction of the supplier’s obligation to pay the December Subscription Monies to ITP and ITIL’s obligation to pay the invoiced amount to the supplier. On July 15, 2019, ITP elected that the supplier subscribe for 17,222 ordinary shares for an aggregate subscription price of $0.11 million (the “July Subscription Monies”) upon receipt by ITIL of valid invoices up to that amount from the supplier (the “Invoiced Amount”). On that date, ITP, ITIL and the supplier executed a payment direction letter pursuant to which the parties directed ITIL to pay $0.11 million (€0.10 million) to ITP in satisfaction of the supplier’s obligation to pay the July Subscription Monies to ITP and ITIL’s obligation to pay the invoiced amount to the supplier. On August 19, 2019, ITP elected that the supplier subscribe for 245,493 ordinary shares for an aggregate subscription price of $1.67 million (the “August Subscription Monies”) upon receipt by ITIL of valid invoices up to that amount from the supplier (the “Invoiced Amount”). On that date, ITP, ITIL and the supplier executed a payment direction letter pursuant to which the parties directed ITIL to pay $1.67 million (€1.50 million) to ITP in satisfaction of the supplier’s obligation to pay the August Subscription Monies to ITP and ITIL’s obligation to pay the invoiced amount to the supplier. On September 30, 2019, ITP elected that the supplier subscribe for 199,056 ordinary shares for an aggregate subscription price of $1.26 million (the “September Subscription Monies”) upon receipt by ITIL of valid invoices up to that amount from the supplier (the “Invoiced Amount”). On that date, ITP, ITIL and the supplier executed a payment direction letter pursuant to which the parties directed ITIL to pay $1.26 million (€1.15 million) to ITP in satisfaction of the supplier’s obligation to pay the September Subscription Monies to ITP and ITIL’s obligation to pay the invoiced amount to the supplier. The holders of ordinary shares are entitled to one vote for each share held. The holders of ordinary shares have no preemptive or other subscription rights, and there are no redemption or sinking fund provisions with respect to such shares. Undesignated Preferred Shares On May 30, 2018, the Company created a new class of undesignated preferred shares of $0.01 each, 100,000,000 of which were authorized immediately prior to closing of the initial public offering. The Directors are authorized by the Company’s Articles of Association to determine the rights attaching to the undesignated preferred shares including rights of redemption, rights as to dividends, rights on winding up and conversion rights. There were no undesignated preferred shares in issue as of December 31, 2019 or December 31, 2018. Convertible Preferred Shares On November 18, 2015, the Company authorized 3,022,915 Series A convertible preferred shares with a par value of $0.01 per share. On the same day, the Company issued 1,514,320 Series A convertible preferred shares for a purchase price of $15.71 per share for: (1) gross cash proceeds of $20,701; (2) the issue of 190,961 convertible preferred shares to Pfizer as part consideration for the license agreement; and (3) the conversion of $90 debt owed by the Company to its founders for a total of 5,728 preferred shares (after taking account of the reverse share split and redenomination of the par value of the convertible preferred shares from $0.01571 (the nominal value resulting from the reverse share split) per share to $0.01 on May 15, 2018). On March 13, 2018, the Company redenominated its 3,032,463 authorized and 3,032,457 issued Series A convertible preferred shares from $0.0001 to $0.001 par value per share in accordance with section 83(1)(c) of the Irish Companies Act. On December 9, 2016, the Company authorized 9,548 Series A convertible preferred shares with a par value of $0.01 per share. On December 16, 2016, the Company issued 1,518,137 Series A convertible preferred shares for a purchase price of $15.71 per share for: (1) gross cash proceeds of $20,851; and (2) the issue of an additional 190,961 convertible preferred shares to Pfizer as part consideration for the license agreement. On May 18, 2017, the Company authorized 2,654,215 Series B-1 convertible preferred shares with a par value of $0.01 per share and 1,042,728 Series B-2 convertible preferred shares with a par value of $0.01 per share (the “Series B convertible preferred shares”). On the same day, the Company issued 2,654,206 Series B-1 convertible preferred shares for a purchase price of $17.28 per share, for gross cash proceeds of $45,867 (after taking account of the reverse share split and redenomination of the par value of the convertible preferred shares from $0.01571 (the nominal value resulting from the reverse share split) per share to $0.01 on May 15, 2018). On March 13, 2018, the Company redenominated its 4,801,493 authorized and 4,363,856 issued Series B convertible preferred shares from $0.0001 to $0.001 par value per share in accordance with section 83(1)(c) of the Irish Companies Act. On February 16, 2018, the Company increased its authorized Series B-2 convertible preferred shares to 2,147,278 shares with a par value of $0.01 per share. On the same day, the Company issued 1,709,650 Series B-2 convertible preferred shares for consideration of $18.85 per share, for gross cash proceeds of $32,230. On May 30, 2018, immediately prior to the completion of the Company’s IPO, holders of convertible preferred shares of Iterum Therapeutics Plc exchanged their preferred shares for ordinary shares of Iterum Therapeutics Plc on a one-for-one basis and all convertible preferred shares were subsequently cancelled. Prior to the exchange and cancellation of preferred convertible shares on May 30, 2018, the ordinary shares were subordinate to the convertible preferred shares with respect to dividend rights and rights upon liquidation, winding up and dissolution of the Company and the holders of ordinary shares were entitled to liquidation proceeds after all liquidation preferences for the convertible preferred shares were satisfied. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | ( 10 ) Share-Based Compensation On November 18, 2015, the Company’s Board of Directors adopted and approved the 2015 Equity Incentive Plan (the “2015 Plan”), which authorized the Company to grant up to 223,424 ordinary shares in the form of incentive share options, nonstatutory share options, share appreciation rights, restricted share awards, restricted share units and other share awards. The types of share-based awards, including the rights amount, terms, and exercisability provisions of grants are determined by the Company’s Board of Directors. The purpose of the 2015 Plan is to provide the Company with the flexibility to issue share-based awards as part of an overall compensation package to attract and retain qualified personnel. On May 18, 2017, the Company amended the 2015 Plan to increase the number of ordinary shares available for issuance under the 2015 Plan by 219,605 shares to 443,029 shares. On March 14, 2018, the Company’s Board of Directors adopted and approved the 2018 Equity Incentive Plan (the “2018 Plan”), which became effective upon the execution and delivery of the underwriting agreement related to the Company’s IPO. No further grants will be made under the 2015 Plan. The ordinary shares underlying any options that are forfeited, cancelled, repurchased or are otherwise terminated by the Company under the 2015 Plan will not be added back to the ordinary shares available for issuance. The 2018 Plan authorizes the Company to grant up to 1,018,459 ordinary shares in the form of incentive share options, nonstatutory share options, share appreciation rights, restricted share awards, restricted share units, performance share awards, performance cash awards and other share awards. The types of share-based awards, including the amount, terms, and exercisability provisions of grants are determined by the Company’s Board of Directors. The ordinary shares underlying any options that are forfeited, cancelled, repurchased or are otherwise terminated by the Company under the 2018 Plan will be added back to the ordinary shares available for issuance under the 2018 Plan. On December 5, 2018, pursuant to powers delegated to it by the Board of Directors of the Company, the Compensation Committee approved an increase in the number of ordinary shares available to be granted pursuant to the 2018 plan by 4% of the total number of shares of the Company’s issued share capital on December 31, 2018, being 574,081 ordinary shares. Restricted Ordinary Shares In connection with the Company’s formation, 413,110 restricted ordinary shares were issued on October 14, 2015 to the Company’s founders at par value. These ordinary shares are subject to various restrictions pursuant to ordinary share purchase agreements between the Company and each founder, including restrictions on transfer and a Company right of repurchase. The restricted ordinary shares were 25% vested as of October 14, 2016 and 1/36 th The Company records share-based compensation expense for the restricted ordinary shares based on the grant date fair value. The Company recorded an expense of $260, $332 and $333 for the years ended December 31, 2019, 2018 and 2017, respectively. There was no unamortized compensation expense related to restricted ordinary shares as of December 31, 2019. Total unamortized compensation expense related to restricted ordinary shares was $260 and $592 as of December 31, 2018 and December 31, 2017, respectively, and was recognized over a weighted average period of 0.79 years and 1.79 years. A summary of the Company’s restricted ordinary share activity and related information is as follows: Number of Weighted Average Grant Date Fair Shares Value per Share Unvested at December 31, 2016 292,620 $ 3.14 Granted — Vested (103,278 ) $ 3.14 Forfeited — Unvested at December 31, 2017 189,342 $ 3.14 Granted — Vested (103,274 ) $ 3.14 Forfeited — Unvested at December 31, 2018 86,068 $ 3.14 Granted — Vested (86,068 ) $ 3.14 Forfeited — Unvested at December 31, 2019 — $ 3.14 Share Options Unless specified otherwise in an individual option agreement, share options granted under the 2015 Plan and the 2018 Plan generally have a ten year term and a four year vesting period. The vesting requirement is conditioned upon a grantee’s continued service with the Company during the vesting period. Once vested, all awards are exercisable from the date of grant until they expire. The option grants are non-transferable. Vested options generally remain exercisable for 90 days subsequent to the termination of the option holder’s service with the Company. In the event of an option holder’s disability or death while employed by or providing service to the Company, the exercisable period extends to twelve months or eighteen months, respectively. The fair value of options granted during the years ended December 31, 2019, 2018 and 2017 was estimated using the Black-Scholes option-pricing model. The inputs for the Black-Scholes model require management’s significant assumptions. The risk-free interest rate was based on a normalized estimate of the 7-year U.S. treasury yield. The Company has estimated the expected term utilizing the “simplified” method for awards that qualify as “plain vanilla”. The Company does not have sufficient company-specific historical and implied volatility information and it therefore estimates its expected share volatility based on historical volatility information of reasonably comparable guideline public companies and itself. The Company expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. Expected dividend yield is based on the fact that the Company has never paid cash dividends, its ability to pay cash dividends is currently prohibited by the terms of its credit facility with SVB and the Company’s future ability to pay cash dividends on its shares may be limited by the terms of any future debt or preferred securities. The Company has elected to account for forfeitures as they occur. The Company granted 512,778, 479,986 and 198,798 share options to employees and directors during the years ended December 31, 2019, 2018 and 2017, respectively. There were 837,386, 566,813 and 228,809 unvested employee and director options outstanding as of December 31, 2019, December 31, 2018 and December 31, 2017, respectively. Total expense recognized related to the employee and director share options was $1,388, $669 and $59 for the years ended December 31, 2019, 2018 and 2017, respectively. Total unamortized compensation expense related to employee and director share options was $3,342, $2,822 and $396 as of December 31, 2019, December 31, 2018 and December 31, 2017, respectively, expected to be recognized over a remaining weighted average vesting period of 2.61 years, 3.07 years and 3.51 years as of December 31, 2019, December 31, 2018 and December 31, 2017, respectively. The range of assumptions that the Company used to determine the grant date fair value of employee and director options granted were as follows: Year ended December 31, 2019 2018 2017 Volatility 68.9 - 74.5% 60% 60% Expected term in years 5.50 - 6.25 6.25 6.25 Dividend rate 0% 0% 0% Risk-free interest rate 1.73 - 2.57% 2.16 - 2.91% 1.63% Share price 3.55 - 6.80 7.06 - 13.00 3.30 - 4.40 Fair value of option on grant date 2.37 - 4.41 4.41 - 7.49 1.88 - 2.50 The following table summarizes the number of options outstanding and the weighted-average exercise price: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value (in thousands) Options outstanding December 31, 2016 49,330 $ 3.14 8.51 Granted 198,798 $ 3.36 Options outstanding December 31, 2017 248,128 $ 3.31 9.44 Granted 479,986 $ 12.60 Exercised (2,008 ) $ 3.30 Forfeited (60,887 ) $ 10.99 Options outstanding December 31, 2018 665,219 $ 9.31 8.93 395 Granted 512,778 $ 5.94 Exercised (18,232 ) $ 3.29 Forfeited (8,726 ) $ 7.43 Expired (769 ) $ 6.77 Options outstanding December 31, 2019 1,150,270 $ 7.92 8.59 254 Exercisable at December 31, 2019 312,884 $ 8.82 8.02 157 The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company’s ordinary shares for those share options that had exercise prices lower than the fair value of the Company’s ordinary shares as of December 31, 2019 and December 31, 2018. The weighted average grant-date fair value per share of share options granted during the years ended December 31, 2019, 2018 and 2017 was $3.80, $7.25 and $1.91, respectively. Restricted Share Units (RSUs) The Company granted 31,367 and 36,924 RSUs to directors during the years ended December 31, 2019 and 2018, respectively. No RSUs were granted prior to the year ended December 31, 2018. The table below shows the number of RSUs granted covering an equal number of the Company’s ordinary shares and the weighted-average grant date fair value of the RSUs granted: Number of Shares Weighted Average Grant Date Fair Value per Share RSUs outstanding December 31, 2017 — Granted 36,924 $ 13.00 Shares vested — Forfeited — RSUs outstanding December 31, 2018 36,924 $ 13.00 Granted 31,367 $ 7.01 Shares vested (36,924 ) $ 13.00 Forfeited — RSUs outstanding December 31, 2019 31,367 $ 7.01 The fair value of the RSUs is determined on the date of grant based on the market price of the Company’s ordinary shares on that date. The fair value of RSUs is expensed ratably over the vesting period, which is generally one year for directors. Total expense recognized related to the RSUs was $313 and $289 for the years ended December 31, 2019 and 2018, respectively. Total unamortized compensation expenses related to the RSUs was $99 and $191 as of December 31, 2019 and December 31, 2018, respectively, expected to be recognized over a remaining average vesting period of 0.45 years and 0.40 years as of December 31, 2019 and December 31, 2018, respectively. The Company awarded 50,000 RSUs to certain employees during the year ended December 31, 2019 which are subject to certain vesting conditions (Performance RSUs). No Performance RSUs were awarded prior to the year ended December 31, 2019. The table below shows the number of Performance RSUs granted covering an equal number of the Company’s ordinary shares and the weighted-average grant date fair value of the Performance RSUs granted: Number of Shares Weighted Average Grant Date Fair Value per Share Performance RSUs outstanding December 31, 2018 — Granted 50,000 $8.21 Shares vested — Forfeited — Performance RSUs outstanding December 31, 2019 50,000 $8.21 The weighted average grant date fair value of Performance RSUs with a market condition was determined using the Monte Carlo simulation model. The fair value of Performance RSUs is expensed ratably over the vesting period. Total expense recognized related to the Performance RSUs was $212 for the year ended December 31, 2019. Total unamortized compensation expenses related to Performance RSUs was $198 as of December 31, 2019 expected to be recognized over a remaining average vesting period of 0.81 years as of December 31, 2019. The Company’s share-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows: Year ended December 31, 2019 2018 2017 Research and development expense $ 723 $ 398 $ 139 General and administrative expense 1,450 892 253 There was a total of $3,639, $3,273 and $988 unamortized share-based compensation expense for restricted ordinary shares, options, restricted share units and performance restricted share units as of December 31, 2019, December 31, 2018 and December 31, 2017, respectively, expected to be recognized over a remaining average vesting period of 2.44 years, 2.71 years and 2.53 years as of December 31, 2019, December 31, 2018 and December 31, 2017, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (1 1 ) Income Taxes During the years ended December 31, 2019, 2018 and 2017, the Company recorded no income tax benefits for the net operating losses incurred in each year due to its uncertainty of realizing a benefit from those items. The provision for income taxes consists of the following components: Year ended December 31, 2019 2018 2017 Current U.S. $ 444 $ 472 $ 444 Ireland — — — Total Current $ 444 $ 472 $ 444 Deferred U.S. $ — $ — $ — Ireland — — — Total Deferred $ — $ — $ — Income Tax Provision $ 444 $ 472 $ 444 Income taxes have been based on the following components of income (loss) before provision for income taxes: Year ended December 31, 2019 2018 2017 U.S. $484 $532 $875 Ireland (103,170) (77,116) (29,837) Total $(102,686) $(76,584) $(28,962) The Irish federal statutory rate is reconciled to the effective tax rate as follows: Year ended December 31, 2019 Year ended December 31, 2018 Year ended December 31, 2017 Statutory rate 12.50% $(12,836) 12.50% $(9,573) 12.50% $(3,620) Impact of U.S. tax rate (0.07)% 72 (0.11)% 81 (0.80)% 232 Impact of valuation allowance (12.91)% 13,258 (11.42)% 8,749 (13.64)% 3,949 Research and development tax credit 0.23% (232) 0.45% (341) 0.76% (220) Adjustments for current tax of prior periods (0.24)% 241 0.00% — 0.00% — Other, net 0.06% (59) (2.03)% 1,557 (0.36)% 103 Effective tax rate (0.43)% $444 (0.61)% $472 (1.54)% $444 The significant components of the Company’s deferred tax assets and liabilities are as follows: Year ended December 31, 2019 2018 2017 Deferred tax assets Share-based compensation $ 679 $ 27 $ 3 Depreciation (24 ) (49 ) 6 Net operating loss carryforwards 26,195 13,648 5,409 163(j) interest expense limitation 730 115 — Other 84 665 239 Valuation allowance (27,664 ) (14,406 ) (5,657 ) Total deferred tax assets $ — $ — $ — Deferred tax liabilities — — — Total deferred tax assets $ — $ — $ — Net deferred tax asset $ — $ — $ — As a Company incorporated in Ireland, it is principally subject to taxation in Ireland. The Company has net operating loss carryforwards in Ireland of approximately $26,195, $13,648 and $5,409 as of the years ended December 31, 2019, 2018 and 2017, respectively, for which a full valuation allowance has been recognized as it was determined that it is more-likely-than-not that these net deferred tax assets will not be realized. The net operating loss carryforwards do not expire, but are carried forward indefinitely. Realization of these deferred tax assets is dependent on the generation of sufficient taxable income. If the Company demonstrates consistent profitability in the future, the evaluation of the recoverability of these deferred tax assets may change and the remaining valuation allowance may be released in part or in whole. While management expects to realize the deferred tax assets, net of valuation allowances, changes in estimates of future taxable income or in tax laws may alter this expectation. On December 22, 2017, the United States federal government enacted the Tax Act, marking a change from a worldwide tax system to a modified territorial tax system in the United States. As part of this change, the Tax Act, among other changes, provided a reduction of the U.S. federal corporate income tax rate from 34% to 21%, an indefinite carryforward of net operating losses incurred in 2018 and future periods, and an interest limitation starting in 2018 with an indefinite carryforward. Any impact to the Company related to these items were accounted for in the 2017, 2018 and 2019 tax provisions with minimal impact. A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows: 2019 2018 Balance at January 1 $ 428 $ 30 Additions 2,033 398 Balance at December 31 $ 2,461 $ 428 The Company is generally subject to examination in the Company’s primary tax jurisdictions for tax years beginning 2015. The Company is not currently subject to any audits or examination. |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (1 2 ) Commitments and Contingencies License Agreement On November 18, 2015, the Company entered into a license agreement with Pfizer for the worldwide exclusive rights to research, develop, manufacture and commercialize sulopenem. As part of the license agreement, the Company is obligated to pay Pfizer potential future regulatory milestone payments, as well as sales milestones upon achievement of net sales ranging from $250.0 million to $1.0 billion for each product type. The Company is also obligated to pay Pfizer royalties ranging from a single-digit to mid-teens percentage based on marginal net sales of each licensed product. Payments to Supplier In June 2016, the Company entered into an agreement with a supplier whereby the Company would pay $2,807 (€2,500) to the supplier to acquire equipment which will be used solely to manufacture product for the Company. In June 2018, the Company entered into a supplemental agreement with this supplier whereby the Company would pay an additional $2,301 (€2,050) under the same terms as the original agreement. These payments will be offset against the price of the product to be supplied under a future supply agreement. No balance remained outstanding to the supplier as of December 31, 2019. $1,604 remained outstanding to the supplier as of December 31, 2018. Contingencies Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. At each reporting date the Company evaluates whether or not a potential loss amount or a potential loss range is probable and reasonably estimable under the provisions of the authoritative guidelines that address accounting for contingencies. The Company expenses costs as incurred in relation to such legal proceedings. The Company is not currently involved in any legal matters arising in the normal course of business. Under the terms of their respective employment agreements, each of the executive officers is eligible to receive severance payments and benefits upon a termination without “cause” or due to “permanent disability”, or upon “resignation for good reason”, contingent upon the named executive officer’s continued performance for the Company. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | (1 3 ) Debt On April 27, 2018, the Company’s subsidiaries, Iterum Therapeutics International Limited, Iterum Therapeutics US Holding Limited and Iterum Therapeutics US Limited (The Borrowers), entered into a Loan and Security Agreement with SVB pursuant to which SVB agreed to lend the Borrowers up to $30,000 in two term loans. $15,000 of the secured credit facility was funded on closing. A second draw of up to $15,000 was available to the Company through October 31, 2019, upon satisfaction of either of the following: (i) the achievement by the Company of both non-inferiority and superiority primary endpoints from its Phase 3 uncomplicated urinary tract infection (uUTI) trial, as well as reporting satisfactory safety data from the trial, or (ii) the achievement of non-inferiority primary endpoints from both its Phase 3 uUTI and complicated urinary tract infection (cUTI) trials, as well as reporting satisfactory safety data from the trials. A non-utilization fee of 1.50% of the aggregate undrawn principal amount was to apply if the Company satisfied the above conditions but chose not to draw down the second term loan. The Company did not satisfy the conditions for the second draw above before the deadline of October 31, 2019. Required monthly amortization payments for the initial $15,000 draw commenced on November 1, 2019 and total principal repayments of $1,034 were made during the year ended December 31, 2019. Interest accrues at a floating per annum rate equal to the greater of (i) 8.31%; or (ii) 3.89% above the Wall Street Journal prime rate, and is payable monthly in arrears. All outstanding principal, plus a 4.20% final interest payment, will be due and payable on the earliest to occur of March 1, 2022 (the maturity date), the acceleration of the term loan or the prepayment of the term loan. The final payment fee of $630 which represents 4.2% of the funded loan, is accreted using the effective interest method over the life of the loan as interest expense. In connection with the initial $15,000 draw, the Company issued SVB and Life Sciences Fund II LLC (LSF) warrants to purchase an aggregate of 19,890 Series B convertible preferred shares (which converted into warrants to purchase 19,890 ordinary shares upon the Company’s IPO) at an exercise price of $18.85 per share. Had the second term loan been drawn down, each of SVB and LSF would have been automatically entitled to purchase additional ordinary shares in an aggregate amount equal to 2.50% of the second term loan divided by the applicable exercise price. The loan proceeds were allocated based on the relative fair values of the debt instrument and the warrant instrument. The fair value of the warrants and the closing costs were recorded as debt discounts and are being amortized using the effective interest rate method over the term of the loan. The effective annual interest rate of the outstanding debt is approximately 11.28% as of December 31, 2019. The Company recognized $1,761 and $1,169 of interest expense related to the loan agreement during the years ended December 31, 2019 and 2018, respectively, including $362 and $360 related to the accretion of the debt discounts and deferred financing costs during the years ended December 31, 2019 and 2018, respectively. Scheduled principal payments on outstanding debt, as of December 31, 2019, are as follows: Year Ending December 31, 2020 6,207 2021 6,207 2022 1,552 $ 13,966 |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (Unaudited) | ( 1 4 ) Quarterly Financial Data (unaudited) Three months ended December 31, 2019 September 30, 2019 June 30, 2019 March 31, 2019 Revenue $ — $ — $ — $ 37 Total operating expenses (23,178 ) (30,999 ) (27,378 ) (20,503 ) Net loss and comprehensive loss (23,641 ) (31,271 ) (27,638 ) (20,580 ) Net loss attributable to ordinary shareholders (23,641 ) (31,271 ) (27,638 ) (20,580 ) Net loss per share attributable to ordinary shareholders – basic and diluted $ (1.59 ) $ (2.15 ) $ (1.93 ) $ (1.44 ) Weighted average ordinary shares outstanding – basic and diluted 14,866,838 14,571,278 14,340,231 14,290,437 Three months ended December 31, 2018 September 30, 2018 June 30, 2018 March 31, 2018 Revenue $ 239 $ 254 $ 185 $ 191 Total operating expenses (24,183 ) (25,240 ) (15,611 ) (12,394 ) Net loss and comprehensive loss (24,258 ) (24,905 ) (15,747 ) (12,146 ) Net loss attributable to ordinary shareholders (24,258 ) (24,905 ) (15,747 ) (12,146 ) Net loss per share attributable to ordinary shareholders – basic and diluted $ (1.72 ) $ (1.77 ) $ (2.22 ) $ (61.36 ) Weighted average ordinary shares outstanding – basic and diluted 14,108,604 14,034,631 7,085,655 197,949 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | ( 1 5 ) Subsequent Events On January 21, 2020, the Company completed a private placement pursuant to which its wholly owned subsidiary, Iterum Bermuda issued and sold approximately $51.6 million aggregate principal amount of Exchangeable Notes RLNs The Units were issued by Iterum Bermuda, which was formed on November 6, 2019 and is a 100% owned “finance subsidiary” of the Company under Rule 3-10 of Regulation S-X with no independent function other than financing activities. Iterum Therapeutics plc, as the parent company, has no independent assets or operations, and its operations are conducted solely through its subsidiaries. The Company and each of its subsidiaries other than Iterum Bermuda (the “Subsidiary Guarantors”) have provided a full and unconditional guarantee of Iterum Bermuda’s obligations under the Exchangeable Notes and the RLNs, and each of the guarantees constitutes the joint and several obligations of the applicable guarantor. The Subsidiary Guarantors are 100% directly or indirectly owned subsidiaries of the Company. There are no significant restrictions upon the Company’s or the Subsidiary Guarantors’ ability to obtain funds from their subsidiaries by dividend or loan. None of the assets of Iterum Bermuda or the Subsidiary Guarantors represent restricted net assets pursuant to Rule 4-08(e)(3) of Regulation S-X. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Going concern | In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) The Company has funded its operations to date primarily with proceeds from the sale of preferred shares and ordinary shares, debt raised under its financing arrangement with SVB, payments received under the CARB-X program and the proceed of a private placement of Exchangeable Notes and RLNs. The Company has incurred operating losses since inception, including net losses of $103,130, $77,056 and $29,406 for the years ended December 31, 2019, 2018 and 2017, respectively. The Company had an accumulated deficit of $234,923 as of December 31, 2019 and expects to continue to incur net losses for the foreseeable future. The Company’s future cash flows are dependent on key variables such as its ability to secure additional sources of funding in the form of public or private financing of debt or equity or collaboration agreements. The Company may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company's shareholders. If the Company is unable to obtain funding, it could be forced to delay, reduce or eliminate some or all of its research and development programs or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, and the Company has successfully raised capital in the past, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. Based on the Company’s operating losses since inception, the expectation of continued operating losses for the foreseeable future, and the need to raise additional capital to finance its future operations, management have concluded there is substantial doubt about the Company’s ability to continue as a going concern within one year from the date these consolidated financial statements are issued. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, the valuation of restricted ordinary shares and the valuation of share-based compensation awards. 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 as there are changes in circumstances, facts and experience. Actual results could differ materially from those estimates. |
Comprehensive Loss | Comprehensive Loss Comprehensive Loss includes net loss as well as other changes in shareholders’ (deficit) / equity that result from transactions and economic events other than those with shareholders. For the periods presented in the accompanying consolidated financial statements, there was no difference between net loss and comprehensive loss. |
Consolidation | Consolidation The accompanying consolidated financial statements include the accounts of Iterum Therapeutics plc and its wholly owned subsidiaries (which are referred to herein, collectively, as the “Company” where context requires). All significant intercompany balances and transactions have been eliminated on consolidation. The Company has no involvement with variable interest entities. |
Short-term investments | Short-term Investments The Company classifies short-term investments as available for sale in accordance with the terms of Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 320, Investments – Debt and Equity Securities |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company’s cash and cash equivalents consist of cash balances and highly liquid investments with maturities of three months or less at the date of purchase. Accounts held at U.S. financial institutions are insured by the FDIC up to $250, while accounts held at Irish financial institutions are insured under the Deposit Guarantee Scheme up to $112 (€100). Cash accounts with any type of restriction are classified as restricted cash. If restrictions are expected to be lifted in the next twelve months, the restricted cash account is classified as current. Included within restricted cash on the Company’s consolidated balance sheet is a certificate of deposit for $90 which is being held by a third party bank as collateral for the irrevocable letter of credit issued in March 2018 to secure an office lease (see Note 12, Commitments and Contingencies). |
Foreign Currencies | Foreign Currencies Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the entity operates (functional currency). The consolidated financial statements are presented in U.S. dollars. Transactions in foreign currencies are recorded at the rate of exchange at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies at the balance sheet date are retranslated into the functional currency at the rate of exchange at the balance sheet date, and the resulting gains and losses are recognized in the consolidated statement of operations and comprehensive loss. Non-monetary items in a foreign currency that are measured in terms of historical cost are translated using the exchange rate at the date of transaction. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Leasehold improvements Shorter of life of lease or 10 years Furniture and fixtures 5 years Laboratory equipment 5 years Computer equipment 3 years Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Repairs and maintenance costs are expensed as incurred. The Company reviews the recoverability of all long-lived assets, including the related useful life, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. |
Leases | Leases The Company determines if an arrangement contains a lease at inception. For arrangements that contain a lease, lease classification, recognition, and measurement are determined at the lease commencement date. The Company has elected to separately account for lease and non-lease components in determining the lease liabilities and right-of-use assets. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The Company’s lease agreements generally do not provide an implicit borrowing rate, therefore the Company uses its incremental borrowing rate at lease commencement to determine the present value of lease payments. The incremental borrowing rate is an entity-specific rate which represents the rate of interest a lessee would pay to borrow on a collateralized basis over a similar term with similar payments. All operating lease expenses are recognized on a straight-line basis over the lease term. |
Research and Development Expenses | Research and Development Expenses The Company expenses the cost of research and development as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including salaries, share-based compensation and benefits, facilities costs, depreciation, manufacturing expenses and external costs of third-parties engaged to supply active pharmaceutical ingredient and drug product and conduct preclinical and clinical development activities and trials, as well as the cost of licensing technology, license fees, and other external costs. Advance payments for goods and services that will be used in future research and development activities are recorded as prepaid expenses and expensed when the activity is performed or when the goods have been received. |
Accrued Research And Development Expenses | Accrued Research and Development Expenses The Company has entered into various research and development contracts with research institutions and other companies. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. This process involves reviewing open contracts and purchase orders, communicating with Company personnel to identify services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advanced payments. The Company estimates accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known at that time. It periodically confirms the accuracy of these estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to: • Vendors, including central laboratories, in connection with preclinical development activities; • Clinical Research Organizations, or CROs, and investigative sites in connection with preclinical studies and clinical trials; and • Contract Manufacturing Organizations, or CMOs, in connection with drug substance and drug product formulation of preclinical and clinical trial materials. The Company bases expenses related to preclinical studies and clinical trials on estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions and CROs that conduct and manage preclinical studies and clinical trials on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the accrual or the amount of prepaid expenses is adjusted accordingly. Although the Company does not expect the estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to prior estimates of accrued research and development expenses. |
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. |
Share-Based Compensation | Share-Based Compensation The Company measures share-based awards granted to employees and directors with service based vesting conditions only based on the fair value on the date of grant using the Black-Scholes option-pricing model. Compensation expense of those awards is recognized over the requisite service period, which is generally the vesting period of the respective award, using the straight-line method. The Company measures share-based awards granted to employees and directors with both performance and service based vesting conditions based on the fair value on the date of grant using the Monte Carlo simulation model. Compensation expense of those awards is recognized over the determined vesting period, the period over which all the specified vesting conditions are to be satisfied, using the straight-line method. For awards granted to consultants and non-employees, compensation expense is recognized over the period during which services are rendered until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the Company’s ordinary shares and updated assumption inputs in the Black-Scholes option-pricing model or the Monte Carlo simulation model. The Company classifies share-based compensation expense in the consolidated 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. The Black-Scholes option-pricing model uses key inputs and assumptions including the expected term of the option, share price volatility, risk-free interest rate, dividend yield, share price and exercise price which is equivalent to closing market value on the date of grant. Many of the assumptions require significant judgment and any changes could have a material impact in the determination of share-based compensation expense. The Monte Carlo simulation model uses key inputs and assumptions including share price volatility, risk-free interest rate, the expected date of satisfaction of vesting conditions and share price. Many of the assumptions require significant judgment and any changes could have a material impact in the determination of share-based compensation expense. The Company has elected to account for forfeitures as they occur. |
Grant Awards | Grant Awards The Company may generate revenue from grant awards that reimburse certain allowable costs for specified projects. For contracts with third parties, when the Company has concluded that it is the principal in conducting the research and development, and where the funding arrangement is considered central to the Company’s ongoing operations, it classifies the recognized funding received as revenue. In June 2017, the Company was granted the CARB-X award in the amount of $1.5 million. The CARB-X award was structured as a cost reimbursement arrangement and was recognized over a period of 20 months from August 2017 to March 2019. The Company recognized the CARB-X award as revenue, rather than as a reduction of research and development expenses, because the Company was the principal in conducting the research and development activities and this contract was central to its ongoing operations. Revenue was recognized as the qualifying expenses related to the contract were incurred. Five steps are applied in the revenue recognition process: (1) identify the contract with a customer; (2) identify the performance obligation in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies the performance obligation. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded in the Company’s consolidated balance sheet as other prepaid assets. The related costs incurred by the Company were included in research and development expenses in the Company’s consolidated statements of operations and comprehensive loss. The Company recognized $37, $869 and $508 as revenue for the years ended December 31, 2019, 2018 and 2017, respectively, in respect of the CARB-X award. |
Research and Development Credits | Research and Development Credits Research and development credits are available to the Company under the tax laws in both Ireland and the U.S., based on qualifying research and development spend in each jurisdiction as defined under those tax laws. Research and development credits are generally recognized as a reduction of research and development expenses. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments FASB guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: • Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. • Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g. quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. • Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. The Company’s short-term investments and its advance payments to a supplier are carried at fair value, determined according to the fair value hierarchy above, see Note 3 for further details. The carrying amounts reported in the consolidated balance sheets for prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair value based on the short-term maturity of these instruments. |
Borrowings | Borrowings Interest bearing long-term debt is recognized initially at fair value, net of transactions costs incurred. Subsequent to initial recognition, interest bearing long-term debt is measured at amortized cost with any difference between cost and redemption value being recognized as a non-cash component of interest expense in the income statement over the period of the borrowings on an effective interest basis. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company has most of its cash and cash equivalents at two accredited financial institutions in the United States, in amounts that exceed federally insured limits. The Company did not hold any short-term investments as of December 31, 2019. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method which requires deferred tax assets and liabilities to be recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as net operating loss carryforwards and research and development tax credits. Valuation allowances are provided if it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that has a greater than 50% likelihood of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest related to unrecognized tax benefits in interest expense and penalties in general and administrative expenses. On December 22, 2017, the United States federal government enacted the Tax Act, marking a change from a worldwide tax system to a modified territorial tax system in the United States. As part of this change, the Tax Act, among other changes, provided a reduction of the U.S. federal corporate income tax rate from 34% to 21%, an indefinite carryforward of net operating losses incurred in 2018 and future periods, and an interest limitation starting in 2018 with an indefinite carryforward. Any impact to the Company related to these items was accounted for in the 2017, 2018 and 2019 tax provisions with minimal impact. |
Net Loss Per Ordinary Share | Net Loss Per Ordinary Share Basic and diluted net loss per ordinary share is determined by dividing net loss attributable to ordinary shareholders by the weighted-average ordinary shares outstanding during the period; in accordance with ASC 260, Earnings per Share The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as they would be anti-dilutive: Year ended December 31, 2019 2018 2017 Options to purchase ordinary shares 1,150,270 665,219 248,128 Preferred shares convertible into ordinary shares — — 5,686,663 Unvested restricted ordinary shares — 86,068 189,342 Unvested restricted share units 31,367 36,924 — Unvested performance restricted share units 50,000 — — Warrants 19,890 19,890 — Total 1,251,527 808,101 6,124,133 The weighted-average shares outstanding used to calculate both basic and diluted loss per ordinary share are the same. |
Segment and Other Information | Segment and Other Information The Company determines and presents operating segments based on the information that is internally provided to the Chief Executive Officer, Chief Scientific Officer and Chief Financial Officer, who together are considered the Company’s chief operating decision maker, in accordance with ASC 280, Segment Reporting The distribution of total operating expenses by geographical area was as follows: Year ended December 31, Operating expenses 2019 2018 2017 Ireland $ 90,792 $ 66,552 $ 24,619 U.S. 11,266 10,876 5,344 Total $ 102,058 $ 77,428 $ 29,963 The distribution of long-lived assets by geographical area was as follows: Long lived assets December 31, 2019 December 31, 2018 Ireland $ 10,936 $ 4,565 U.S. 3,037 245 Total $ 13,973 $ 4,810 |
Retirement Plan | Retirement Plan The Company has a defined contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all U.S. employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pre-tax basis. If the 401(k) Plan is considered top-heavy at the end of the financial year, with key employee accounts accounting for >60% of total 401(k) Plan assets, the Company is required to contribute a deferral rate of up to 3% to the 401(k) Plan on behalf of certain employees. The Company was not required to make a top-heavy contribution for the year ended December 31, 2019. The Company made contributions of $114 and $33 for the years ended December 31, 2018 and 2017, respectively. |
Inventory | Inventory Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. The Company’s policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on the estimates of future demand for a particular product. If the estimate of future demand changes, the Company considers the impact on the reserve for excess inventory and adjusts the reserve as required. Increases in the reserve are recorded as charges in cost of product sales. For product candidates that have not been approved by the FDA, inventory used in clinical trials is expensed at the time of production and recorded as research and development expenses. For products that have been approved by the FDA, inventory used in clinical trials is expensed at the time the inventory is packaged for the clinical trial. Prior to an advisory committee providing a recommendation to the FDA that the Company’s application should be approved, costs related to manufacturing the product candidates are recorded as research and development expenses. All direct manufacturing costs incurred after this recommendation will be capitalized into inventory. The Company had no inventory as of December 31, 2019 or December 31, 2018. |
Contingent Consideration | Contingent Consideration Certain license agreements contain milestone payments that could result in the requirement to make contingent consideration payments, see Note 12 for further details. Contingent consideration is recorded at the acquisition date estimated fair value of the contingent payment. The fair value of the contingent consideration is measured at each reporting period. Any related unwinding of discount is recognized as a finance expense. Other changes in fair value are recognized in profit or loss or capitalized as an intangible asset depending on the stage of development. As of December 31, 2019, no milestones had been met that required the Company to recognize contingent consideration. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (FASB) issued ASU 2016-02, Leases Leases Targeted Improvements Leases Codification Improvements ASU 2016-02 requires a lessee to recognize a liability to make lease payments (the lease liability) and a right-of-use asset, representing its right to use the underlying asset for the lease term, on the balance sheet. The Company adopted ASU 2016-02 in the first quarter of 2019 utilizing the modified retrospective transition method with an effective date as the date of initial application. Consequently, prior period balances and disclosures have not been restated. The adoption of ASU 2016-02 on January 1, 2019 resulted in the recognition of right-of-use assets of $7.6 million and operating lease liabilities of $7.8 million, however, the adoption of the standard did not have an impact on the Company’s beginning retained earnings, results from operations or cash flows. See Note 7 for further information regarding the impact of the adoption of ASU 2016-02 on the Company's consolidated financial statements. In July 2017, the FASB issued ASU 2017-11, Earnings Per Share Distinguishing Liabilities from Equity Derivatives and Hedging Part I applies to entities that issue financial instruments such as warrants, convertible debt or convertible preferred shares that contain down-round features. Part II replaces the indefinite deferral for certain mandatorily redeemable noncontrolling interests and mandatorily redeemable financial instruments of nonpublic entities contained within ASC Topic 480 with a scope exception and does not impact the accounting for these mandatorily redeemable instruments. ASU 2017-11 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of ASU 2017-11 did not have an impact on the Company’s consolidated financial statements. In June 2018, the FASB issued ASU 2018-07, Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting ASU 2018-07 expands the scope of Topic 718 to include all share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 specifies that Topic 718 applies to all share-based payment transactions in which the grantor acquires goods and services to be used or consumed in its own operations by issuing share-based payment awards. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under ASC 606. ASU 2018-07 is required to be adopted for annual periods beginning after December 15, 2019, including interim periods within those fiscal years. The adoption of ASU 2018-07 did not have an impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements There are no recently issued accounting pronouncements that will have a material impact on the Company’s consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment Depreciated Using the Straight-Line Method Over the Estimated Useful Life of Each Asset | Property and equipment are stated at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Leasehold improvements Shorter of life of lease or 10 years Furniture and fixtures 5 years Laboratory equipment 5 years Computer equipment 3 years |
Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares Outstanding | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as they would be anti-dilutive: Year ended December 31, 2019 2018 2017 Options to purchase ordinary shares 1,150,270 665,219 248,128 Preferred shares convertible into ordinary shares — — 5,686,663 Unvested restricted ordinary shares — 86,068 189,342 Unvested restricted share units 31,367 36,924 — Unvested performance restricted share units 50,000 — — Warrants 19,890 19,890 — Total 1,251,527 808,101 6,124,133 |
Schedule of Distribution of Total Operating Expenses by Geographical Area | The distribution of total operating expenses by geographical area was as follows: Year ended December 31, Operating expenses 2019 2018 2017 Ireland $ 90,792 $ 66,552 $ 24,619 U.S. 11,266 10,876 5,344 Total $ 102,058 $ 77,428 $ 29,963 |
Schedule of Distribution of Long-Lived Assets by Geographical Area | The distribution of long-lived assets by geographical area was as follows: Long lived assets December 31, 2019 December 31, 2018 Ireland $ 10,936 $ 4,565 U.S. 3,037 245 Total $ 13,973 $ 4,810 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets Measured at Fair Value | The following table presents information about the Company’s financial assets that were carried at fair value on a recurring basis on the consolidated balance sheet as of December 31, 2019 and December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value. December 31, 2019 Assets Total Level 1 Level 2 Level 3 Other assets – advance payment to supplier 3,884 — — 3,884 December 31, 2018 Assets Total Level 1 Level 2 Level 3 Short-term investments $ 40,000 40,000 — — Other assets – advance payment to supplier 2,649 — — 2,649 Total $ 42,649 40,000 — 2,649 |
Summary of Long-term Debt Carried at Amortized Cost on Consolidated Balance Sheet | The following table presents information about the Company’s long-term debt which was carried at amortized cost on the consolidated balance sheet as of December 31, 2019 and December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine the approximate fair value. December 31, 2019 Liabilities Book Value Approximate Fair Value Level 1 Level 2 Level 3 Current portion of long-term debt $ 5,800 $ 5,800 — 5,800 — Long-term debt, less current portion 7,625 7,213 — 7,213 — Total $ 13,425 $ 13,013 — 13,013 — December 31, 2018 Liabilities Book Value Approximate Fair Value Level 1 Level 2 Level 3 Current portion of long-term debt $ 1,019 $ 1,019 — 1,019 — Long-term debt, less current portion 13,079 13,035 — 13,035 — Total $ 14,098 $ 14,054 — 14,054 — |
Short Term Investments (Tables)
Short Term Investments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Available For Sale Securities [Abstract] | |
Schedule of Available for Sale Short-term Investments by Major Security Types | The Company did not hold any short-term investments as of December 31, 2019. The following table represents the Company’s available for sale short-term investments by major security type as of December 31, 2018: December 31, 2018 Maturity by period Unrealized Unrealized Fair Value Less than 1 Available for sale Cost Total gains (losses) Total year 1 to 5 years Commercial paper $ 35,745 272 (9 ) 36,008 36,008 — U.S. Treasury and Agency Bonds 3,977 15 — 3,992 3,992 — Total $ 39,722 287 (9 ) 40,000 40,000 — |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Summary of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following: December 31, 2019 December 31, 2018 Deferred financing expenses (1) $ 2,339 — Prepaid research and development expenses 1,679 5,351 Short-term deposits 1,139 959 Research and development tax credit receivable 1,036 404 Prepaid insurance 569 438 Value added tax receivable 68 159 Other prepaid assets 50 921 Interest receivable 7 158 Total $ 6,887 $ 8,390 (1) See note 15 to the consolidated financial statements for further details deferred financing expenses. |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment and Related Accumulated Depreciation | Property and equipment and related accumulated depreciation are as follows: December 31, 2019 December 31, 2018 Leasehold improvements $ 592 $ 592 Furniture and fixtures 120 120 Laboratory equipment 81 81 Computer equipment 132 108 925 901 Less: accumulated depreciation (353 ) (201 ) $ 572 $ 700 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Summary of Right-of-Use Assets and Lease Liabilities | Information related to the Company’s right-of-use assets and related lease liabilities is as follows: Year Ended December 31, 2019 Cash paid for operating lease liabilities $ 826 Right-of-use assets obtained in exchange for new operating lease obligation (1) 7,622 (1) All operating lease included above were held at January 01, 2019. December 31, 2019 Weighted-average remaining lease term 12.5 years Weighted-average discount rate 7.6% Right-of-use assets and lease liabilities for the Company’s operating leases were recorded in the consolidated balance sheet as follows, representing the Company’s right to use the underlying asset for the lease term (“Other assets”) and the Company’s obligation to make lease payments (“Other current liabilities” and “Other liabilities”): December 31, 2019 Other assets $7,144 Other current liabilities $580 Other liabilities 6,748 Total lease liabilities $7,328 |
Schedule of Future Lease Payments Included in Measurement of Lease Liabilities on Condensed Consolidated Balance Sheet | The Company has recorded the reduction in carrying amount of the right-of-use assets and the change in the lease liability in the Other category within the operating section of the consolidated statement of cash flows. Future lease payments included in the measurement of lease liabilities on the consolidated balance sheet as of December 31, 2019 for the following five fiscal years and thereafter were as follows: Due in 12 month period ended December 31, 2020 $1,099 2021 1,023 2022 1,032 2023 1,038 2024 1,042 Thereafter 5,641 $10,875 Less imputed interest (3,547) Total lease liabilities $7,328 |
Schedule of Future Minimum Lease Payments Under Non-cancelable Operating Leases | As of December 31, 2018, future minimum lease payments, as defined under the previous lease accounting guidance of ASC Topic 840, under non-cancelable operating leases for the following five fiscal years and thereafter were as follows: Due in 12 month period ended December 31, 2019 $904 2020 1,020 2021 1,030 2022 985 2023 766 Thereafter 2,356 $7,061 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: December 31, 2019 December 31, 2018 Accrued clinical trial costs $ 9,866 $ 2,849 Accrued payroll and bonus expenses 1,207 1,804 Accrued manufacturing expenses 136 1,439 Accrued other expenses 1,249 954 Total $ 12,458 $ 7,046 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Restricted Ordinary Shares Activity | A summary of the Company’s restricted ordinary share activity and related information is as follows: Number of Weighted Average Grant Date Fair Shares Value per Share Unvested at December 31, 2016 292,620 $ 3.14 Granted — Vested (103,278 ) $ 3.14 Forfeited — Unvested at December 31, 2017 189,342 $ 3.14 Granted — Vested (103,274 ) $ 3.14 Forfeited — Unvested at December 31, 2018 86,068 $ 3.14 Granted — Vested (86,068 ) $ 3.14 Forfeited — Unvested at December 31, 2019 — $ 3.14 |
Schedule of Assumptions Used to Determine Grant Date Fair Value of Employee and Director Options Granted | The range of assumptions that the Company used to determine the grant date fair value of employee and director options granted were as follows: Year ended December 31, 2019 2018 2017 Volatility 68.9 - 74.5% 60% 60% Expected term in years 5.50 - 6.25 6.25 6.25 Dividend rate 0% 0% 0% Risk-free interest rate 1.73 - 2.57% 2.16 - 2.91% 1.63% Share price 3.55 - 6.80 7.06 - 13.00 3.30 - 4.40 Fair value of option on grant date 2.37 - 4.41 4.41 - 7.49 1.88 - 2.50 |
Summary of Number of Options Outstanding and Weighted-average Exercise Price | The following table summarizes the number of options outstanding and the weighted-average exercise price: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value (in thousands) Options outstanding December 31, 2016 49,330 $ 3.14 8.51 Granted 198,798 $ 3.36 Options outstanding December 31, 2017 248,128 $ 3.31 9.44 Granted 479,986 $ 12.60 Exercised (2,008 ) $ 3.30 Forfeited (60,887 ) $ 10.99 Options outstanding December 31, 2018 665,219 $ 9.31 8.93 395 Granted 512,778 $ 5.94 Exercised (18,232 ) $ 3.29 Forfeited (8,726 ) $ 7.43 Expired (769 ) $ 6.77 Options outstanding December 31, 2019 1,150,270 $ 7.92 8.59 254 Exercisable at December 31, 2019 312,884 $ 8.82 8.02 157 |
Summary of Number of RSUs Granted and Weighted-average Grant Date Fair Value of RSUs | The table below shows the number of RSUs granted covering an equal number of the Company’s ordinary shares and the weighted-average grant date fair value of the RSUs granted: Number of Shares Weighted Average Grant Date Fair Value per Share RSUs outstanding December 31, 2017 — Granted 36,924 $ 13.00 Shares vested — Forfeited — RSUs outstanding December 31, 2018 36,924 $ 13.00 Granted 31,367 $ 7.01 Shares vested (36,924 ) $ 13.00 Forfeited — RSUs outstanding December 31, 2019 31,367 $ 7.01 |
Summary of Share-based Compensation Expense | The Company’s share-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows: Year ended December 31, 2019 2018 2017 Research and development expense $ 723 $ 398 $ 139 General and administrative expense 1,450 892 253 |
Performance RSUs | |
Summary of Number of RSUs Granted and Weighted-average Grant Date Fair Value of RSUs | The table below shows the number of Performance RSUs granted covering an equal number of the Company’s ordinary shares and the weighted-average grant date fair value of the Performance RSUs granted: Number of Shares Weighted Average Grant Date Fair Value per Share Performance RSUs outstanding December 31, 2018 — Granted 50,000 $8.21 Shares vested — Forfeited — Performance RSUs outstanding December 31, 2019 50,000 $8.21 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense Benefits | The provision for income taxes consists of the following components: Year ended December 31, 2019 2018 2017 Current U.S. $ 444 $ 472 $ 444 Ireland — — — Total Current $ 444 $ 472 $ 444 Deferred U.S. $ — $ — $ — Ireland — — — Total Deferred $ — $ — $ — Income Tax Provision $ 444 $ 472 $ 444 |
Summary of Components of Income (Loss) Before Provision for Income Taxes | Income taxes have been based on the following components of income (loss) before provision for income taxes: Year ended December 31, 2019 2018 2017 U.S. $484 $532 $875 Ireland (103,170) (77,116) (29,837) Total $(102,686) $(76,584) $(28,962) |
Summary of Effective Income Tax Rate | The Irish federal statutory rate is reconciled to the effective tax rate as follows: Year ended December 31, 2019 Year ended December 31, 2018 Year ended December 31, 2017 Statutory rate 12.50% $(12,836) 12.50% $(9,573) 12.50% $(3,620) Impact of U.S. tax rate (0.07)% 72 (0.11)% 81 (0.80)% 232 Impact of valuation allowance (12.91)% 13,258 (11.42)% 8,749 (13.64)% 3,949 Research and development tax credit 0.23% (232) 0.45% (341) 0.76% (220) Adjustments for current tax of prior periods (0.24)% 241 0.00% — 0.00% — Other, net 0.06% (59) (2.03)% 1,557 (0.36)% 103 Effective tax rate (0.43)% $444 (0.61)% $472 (1.54)% $444 |
Summary of Significant Components of Deferred Tax Assets and Liabilities | The significant components of the Company’s deferred tax assets and liabilities are as follows: Year ended December 31, 2019 2018 2017 Deferred tax assets Share-based compensation $ 679 $ 27 $ 3 Depreciation (24 ) (49 ) 6 Net operating loss carryforwards 26,195 13,648 5,409 163(j) interest expense limitation 730 115 — Other 84 665 239 Valuation allowance (27,664 ) (14,406 ) (5,657 ) Total deferred tax assets $ — $ — $ — Deferred tax liabilities — — — Total deferred tax assets $ — $ — $ — Net deferred tax asset $ — $ — $ — |
Summary of Gross Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows: 2019 2018 Balance at January 1 $ 428 $ 30 Additions 2,033 398 Balance at December 31 $ 2,461 $ 428 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Principal Payments on Outstanding Debt | Scheduled principal payments on outstanding debt, as of December 31, 2019, are as follows: Year Ending December 31, 2020 6,207 2021 6,207 2022 1,552 $ 13,966 |
Quarterly Financial Data (Una_2
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Unaudited Quarterly Financial Data | Three months ended December 31, 2019 September 30, 2019 June 30, 2019 March 31, 2019 Revenue $ — $ — $ — $ 37 Total operating expenses (23,178 ) (30,999 ) (27,378 ) (20,503 ) Net loss and comprehensive loss (23,641 ) (31,271 ) (27,638 ) (20,580 ) Net loss attributable to ordinary shareholders (23,641 ) (31,271 ) (27,638 ) (20,580 ) Net loss per share attributable to ordinary shareholders – basic and diluted $ (1.59 ) $ (2.15 ) $ (1.93 ) $ (1.44 ) Weighted average ordinary shares outstanding – basic and diluted 14,866,838 14,571,278 14,340,231 14,290,437 Three months ended December 31, 2018 September 30, 2018 June 30, 2018 March 31, 2018 Revenue $ 239 $ 254 $ 185 $ 191 Total operating expenses (24,183 ) (25,240 ) (15,611 ) (12,394 ) Net loss and comprehensive loss (24,258 ) (24,905 ) (15,747 ) (12,146 ) Net loss attributable to ordinary shareholders (24,258 ) (24,905 ) (15,747 ) (12,146 ) Net loss per share attributable to ordinary shareholders – basic and diluted $ (1.72 ) $ (1.77 ) $ (2.22 ) $ (61.36 ) Weighted average ordinary shares outstanding – basic and diluted 14,108,604 14,034,631 7,085,655 197,949 |
Nature of Operations and Basi_2
Nature of Operations and Basis of Presentation - Additional Information (Details) | Jan. 21, 2020USD ($)Debtinstrumentshares | Jun. 26, 2018USD ($)$ / sharesshares | May 30, 2018USD ($)$ / sharesshares | May 15, 2018$ / shares | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Jul. 16, 2019USD ($) |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||||||||||||||
Reverse share split | 0.0636 | |||||||||||||||
Share consolidation basis nominal value per share | $ / shares | $ 0.01571 | |||||||||||||||
Share consolidation basis, Renominalisation value per share | $ / shares | $ 0.01 | |||||||||||||||
Net proceeds from issuance of stock after deducting underwriting discounts,commissions and offering cost | $ 2,400,000 | $ 71,800,000 | $ 74,153,000 | |||||||||||||
Net losses | $ 23,641,000 | $ 31,271,000 | $ 27,638,000 | $ 20,580,000 | $ 24,258,000 | $ 24,905,000 | $ 15,747,000 | $ 12,146,000 | $ 103,130,000 | 77,056,000 | $ 29,406,000 | |||||
Accumulated deficit | $ 234,923,000 | $ 131,793,000 | $ 234,923,000 | $ 131,793,000 | ||||||||||||
Maximum | ||||||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||||||||||||||
Aggregate initial offering price of securities authorized to issue | $ 150,000,000 | |||||||||||||||
IPO | ||||||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||||||||||||||
Number of shares issued | shares | 200,000 | 6,150,000 | ||||||||||||||
Offering price per share | $ / shares | $ 13 | $ 13 | ||||||||||||||
Subsequent Event | Private Placement | Exchangeable Notes | ||||||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||||||||||||||
Aggregate principal amount | $ 51,600,000 | |||||||||||||||
Debt instrument interest rate | 6.50% | |||||||||||||||
Debt instrument price per unit | $ 1,000 | |||||||||||||||
Subsequent Event | Private Placement | RLNs | ||||||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||||||||||||||
Aggregate principal amount | $ 100,000 | |||||||||||||||
Number of debt instruments within each notes | Debtinstrument | 50 | |||||||||||||||
Debt instrument, aggregate potential payment capped value | $ 160,000 | |||||||||||||||
Debt instrument, aggregate potential payment capped rate | 4,000 times | |||||||||||||||
Subsequent Event | Private Placement | RLNs | Minimum | ||||||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||||||||||||||
Debt instrument, percentage of net revenue from domestic sale for potential aggregate payments | 15.00% | |||||||||||||||
Subsequent Event | Private Placement | RLNs | Maximum | ||||||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||||||||||||||
Debt instrument, percentage of net revenue from domestic sale for potential aggregate payments | 20.00% | |||||||||||||||
Subsequent Event | Private Placement | Securities | ||||||||||||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||||||||||||||
Debt instrument price per unit | $ 1,000 | |||||||||||||||
Debt instrument, shares embedded within each unit, shares | shares | 1,000 | |||||||||||||||
Debt instrument, shares embedded within each unit, value | $ 1,000 | |||||||||||||||
Proceeds from sale of securities | $ 46,700,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) € in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Jun. 30, 2017USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($)Segment | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2019EUR (€) | Jan. 01, 2019USD ($) | |
Accounting Policies [Line Items] | |||||||||||
Restricted cash | $ 30,000 | $ 30,000 | $ 30,000 | ||||||||
Research and development funding arrangement, sub award granted | $ 1,500 | ||||||||||
Cost reimbursement arrangement recognition period | 20 months | ||||||||||
Cost reimbursement arrangement recognition beginning period | 2017-08 | ||||||||||
Revenue | $ 37,000 | 239,000 | $ 254,000 | $ 185,000 | $ 191,000 | $ 37,000 | $ 869,000 | $ 508,000 | |||
Type of Revenue [Extensible List] | us-gaap:GrantMember | us-gaap:GrantMember | us-gaap:GrantMember | ||||||||
Short-term investments | $ 40,000,000 | $ 0 | $ 40,000,000 | ||||||||
Recognized income tax positions measured at largest amount greater than percentage of being realized | 50.00% | ||||||||||
Number of business segments | Segment | 1 | ||||||||||
Defined contribution plan, employee minimum percentage of total plan assets | 60.00% | ||||||||||
Defined contribution plan, maximum deferral rate | 3.00% | ||||||||||
Defined Contribution Plan, Tax Status [Extensible List] | us-gaap:QualifiedPlanMember | us-gaap:QualifiedPlanMember | |||||||||
Defined benefit plan, contribution by employer | $ 114,000 | $ 33,000 | |||||||||
Inventory | $ 0 | $ 0 | $ 0 | ||||||||
Milestone payments | 0 | ||||||||||
Right-of-use asset | 7,144,000 | ||||||||||
Lease liability | $ 7,328,000 | ||||||||||
ASU 2016-02 | |||||||||||
Accounting Policies [Line Items] | |||||||||||
Right-of-use asset | $ 7,600,000 | ||||||||||
Lease liability | $ 7,800,000 | ||||||||||
U.S. Tax Authority | |||||||||||
Accounting Policies [Line Items] | |||||||||||
Federal statutory tax rate | 21.00% | 21.00% | 34.00% | ||||||||
Certificates Of Deposit | |||||||||||
Accounting Policies [Line Items] | |||||||||||
Restricted cash | $ 90,000 | ||||||||||
Maximum | |||||||||||
Accounting Policies [Line Items] | |||||||||||
Cash, FDIC insured amount | 250,000 | ||||||||||
Cash, DGS insured amount | $ 112,000 | € 100 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Property and Equipment Depreciated Using the Straight-Line Method Over the Estimated Useful Life of Each Asset (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Leasehold Improvements | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | Shorter of life of lease or 10 years |
Furniture and Fixtures | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 5 years |
Laboratory Equipment | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 5 years |
Computer Equipment | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 3 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares Outstanding (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computation of diluted weighted-average shares outstanding | 1,251,527 | 808,101 | 6,124,133 |
Options to Purchase Ordinary Shares | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computation of diluted weighted-average shares outstanding | 1,150,270 | 665,219 | 248,128 |
Preferred Shares Convertible into Ordinary Shares | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computation of diluted weighted-average shares outstanding | 5,686,663 | ||
Unvested Restricted Ordinary Shares | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computation of diluted weighted-average shares outstanding | 86,068 | 189,342 | |
Unvested Restricted Share Units | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computation of diluted weighted-average shares outstanding | 31,367 | 36,924 | |
Unvested Performance Restricted Share Units | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computation of diluted weighted-average shares outstanding | 50,000 | ||
Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computation of diluted weighted-average shares outstanding | 19,890 | 19,890 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Distribution of Total Operating Expenses by Geographical Area (Details) - USD ($) $ 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 | Dec. 31, 2017 | |
Segment Reporting Information [Line Items] | |||||||||||
Operating expenses | $ 23,178 | $ 30,999 | $ 27,378 | $ 20,503 | $ 24,183 | $ 25,240 | $ 15,611 | $ 12,394 | $ 102,058 | $ 77,428 | $ 29,963 |
Ireland | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Operating expenses | 90,792 | 66,552 | 24,619 | ||||||||
U.S. | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Operating expenses | $ 11,266 | $ 10,876 | $ 5,344 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Distribution of Long-Lived Assets by Geographical Area (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Segment Reporting Information [Line Items] | ||
Long lived assets | $ 13,973 | $ 4,810 |
Ireland | ||
Segment Reporting Information [Line Items] | ||
Long lived assets | 10,936 | 4,565 |
U.S. | ||
Segment Reporting Information [Line Items] | ||
Long lived assets | $ 3,037 | $ 245 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities (Schedule of Financial Assets Measured at Fair Value) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Other assets – advance payment to supplier | $ 3,884 | $ 2,649 |
Short-term investments | 40,000 | |
Total | 42,649 | |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 40,000 | |
Total | 40,000 | |
Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Other assets – advance payment to supplier | $ 3,884 | 2,649 |
Total | $ 2,649 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | ||
Discounted cash flow include a discount rate | 15.00% | 15.00% |
Fair value, assets Level 1 to Level 2 transfers, amount | $ 0 | |
Fair value, liabilities Level 1 to Level 2 transfers, amount | 0 | |
Fair value, assets Level 2 to Level 1 transfers, amount | 0 | |
Fair value, liabilities Level 2 to Level 1 transfers, amount | 0 | |
Fair value, asset Level 3 transfers amount | 0 | |
Fair value, liabilities Level 3 transfers amount | $ 0 |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities - Summary of Long-term Debt Carried at Amortized Cost on Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Book Value | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Current portion of long-term debt | $ 5,800 | $ 1,019 |
Long-term debt, less current portion | 7,625 | 13,079 |
Total | 13,425 | 14,098 |
Approximate Fair Value | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Current portion of long-term debt | 5,800 | 1,019 |
Long-term debt, less current portion | 7,213 | 13,035 |
Total | 13,013 | 14,054 |
Level 2 | Approximate Fair Value | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Current portion of long-term debt | 5,800 | 1,019 |
Long-term debt, less current portion | 7,213 | 13,035 |
Total | $ 13,013 | $ 14,054 |
Short Term Investments - Additi
Short Term Investments - Additional Information (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Available For Sale Securities [Abstract] | ||
Short-term investments | $ 0 | $ 40,000,000 |
Short Term Investments - Schedu
Short Term Investments - Schedule of Available for Sale Short-term Investments by Major Security Types (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Schedule Of Available For Sale Securities [Line Items] | |
Available for sale, Cost Total | $ 39,722 |
Available for sale, Unrealized gains | 287 |
Available for sale, Unrealized (losses) | (9) |
Available for sale, Fair Value Total | 40,000 |
Available for sale, Maturity by period Less than 1 year | 40,000 |
Commercial Paper | |
Schedule Of Available For Sale Securities [Line Items] | |
Available for sale, Cost Total | 35,745 |
Available for sale, Unrealized gains | 272 |
Available for sale, Unrealized (losses) | (9) |
Available for sale, Fair Value Total | 36,008 |
Available for sale, Maturity by period Less than 1 year | 36,008 |
U.S. Treasury and Agency Bonds | |
Schedule Of Available For Sale Securities [Line Items] | |
Available for sale, Cost Total | 3,977 |
Available for sale, Unrealized gains | 15 |
Available for sale, Fair Value Total | 3,992 |
Available for sale, Maturity by period Less than 1 year | $ 3,992 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Deferred financing expenses | $ 2,339 | |
Prepaid research and development expenses | 1,679 | $ 5,351 |
Short-term deposits | 1,139 | 959 |
Research and development tax credit receivable | 1,036 | 404 |
Prepaid insurance | 569 | 438 |
Value added tax receivable | 68 | 159 |
Other prepaid assets | 50 | 921 |
Interest receivable | 7 | 158 |
Total | $ 6,887 | $ 8,390 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment and Related Accumulated Depreciation (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 925 | $ 901 |
Less: accumulated depreciation | (353) | (201) |
Property and equipment, net | 572 | 700 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 592 | 592 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 120 | 120 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 81 | 81 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 132 | $ 108 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | |||
Depreciation expense | $ 152 | $ 136 | $ 65 |
Leases - Additional Information
Leases - Additional Information (Details) - Office Space and Commercial Property $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Operating Leased Assets [Line Items] | |
Lessee, operating lease, description | These leases have terms which range from four to 19 years, and generally include one or more options to terminate or renew. |
Lessee, operating lease, option to terminate | The termination options can reduce the lease term for periods ranging from five to 10 years |
Lessee, operating lease, option to extend | The renewal terms can extend the lease term for additional periods ranging from three to five years. |
Operating lease cost for right - of - use assets | $ 1,015 |
Minimum | |
Operating Leased Assets [Line Items] | |
Lessee, operating lease, term of contract | 4 years |
Lessee, operating lease, terminate term | 5 years |
Lessee, operating lease, renewal term | 3 years |
Maximum | |
Operating Leased Assets [Line Items] | |
Lessee, operating lease, term of contract | 19 years |
Lessee, operating lease, terminate term | 10 years |
Lessee, operating lease, renewal term | 5 years |
Leases - Summary of Right-of-Us
Leases - Summary of Right-of-Use Assets and Lease Liabilities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases [Abstract] | |
Cash paid for operating lease liabilities | $ 826 |
Right-of-use assets obtained in exchange for new operating lease obligation | $ 7,622 |
Weighted-average remaining lease term | 12 years 6 months |
Weighted-average discount rate | 7.60% |
Leases - Summary of Right-of-_2
Leases - Summary of Right-of-Use Assets and Lease Liabilities for Operating Leases Recorded in Condensed Consolidated Balance Sheet (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Schedule Of Lease Assets And Liabilities [Abstract] | |
Other assets | $ 7,144 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsMember |
Other current liabilities | $ 580 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherCurrentLiabilitiesMember |
Other liabilities | $ 6,748 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesMember |
Total lease liabilities | $ 7,328 |
Leases - Schedule of Future Lea
Leases - Schedule of Future Lease Payments Included in Measurement of Lease Liabilities on Condensed Consolidated Balance Sheet (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 1,099 |
2021 | 1,023 |
2022 | 1,032 |
2023 | 1,038 |
2024 | 1,042 |
Thereafter | 5,641 |
Total | 10,875 |
Less imputed interest | (3,547) |
Total lease liabilities | $ 7,328 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments Under Non-cancelable Operating Leases (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 904 |
2020 | 1,020 |
2021 | 1,030 |
2022 | 985 |
2023 | 766 |
Thereafter | 2,356 |
Total | $ 7,061 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued clinical trial costs | $ 9,866 | $ 2,849 |
Accrued payroll and bonus expenses | 1,207 | 1,804 |
Accrued manufacturing expenses | 136 | 1,439 |
Accrued other expenses | 1,249 | 954 |
Total | $ 12,458 | $ 7,046 |
Shareholders' (Deficit) _ Equ_2
Shareholders' (Deficit) / Equity - Additional Information (Details) $ / shares in Units, € in Thousands, $ in Thousands | Feb. 16, 2018USD ($)$ / sharesshares | May 18, 2017USD ($)$ / sharesshares | Dec. 16, 2016USD ($)$ / sharesshares | Nov. 18, 2015USD ($)$ / sharesshares | Dec. 31, 2019Vote$ / sharesshares | Dec. 31, 2018$ / sharesshares | Sep. 30, 2019USD ($)shares | Sep. 30, 2019EUR (€)shares | Aug. 19, 2019USD ($)shares | Aug. 19, 2019EUR (€)shares | Jul. 15, 2019USD ($)shares | Jul. 15, 2019EUR (€)shares | Dec. 14, 2018USD ($)shares | Dec. 14, 2018EUR (€)shares | May 30, 2018$ / sharesshares | May 29, 2018shares | May 15, 2018$ / shares | Mar. 13, 2018$ / sharesshares | Mar. 12, 2018$ / shares | Feb. 15, 2018shares | Dec. 09, 2016$ / sharesshares | Oct. 14, 2015$ / sharesshares |
Class Of Stock [Line Items] | ||||||||||||||||||||||
Ordinary shares, shares authorized | 44,557,606 | 7,956,715 | 3,659,453 | 50,000,000 | 50,000,000 | 50,000,000 | 44,557,606 | 413,110 | ||||||||||||||
Ordinary shares, shares issued | 14,868,973 | 14,352,046 | 413,110 | 413,110 | ||||||||||||||||||
Ordinary shares, par value | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.001 | $ 0.0001 | $ 0.01 | |||||||||||||
Share consolidation basis nominal value per share | $ / shares | $ 0.01571 | |||||||||||||||||||||
Share consolidation basis, Renominalisation value per share | $ / shares | 0.01 | |||||||||||||||||||||
Increase in common stock, shares authorized | 5,442,394 | 36,600,891 | ||||||||||||||||||||
Number of vote per common share | Vote | 1 | |||||||||||||||||||||
Common stock rights and preferences | The holders of ordinary shares have no preemptive or other subscription rights, and there are no redemption or sinking fund provisions with respect to such shares | |||||||||||||||||||||
Preferred stock, conversion basis | one-for-one | |||||||||||||||||||||
Undesignated Preferred Shares | ||||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||||
Undesignated preferred shares, par value | $ / shares | $ 0.01 | |||||||||||||||||||||
Undesignated preferred shares, authorized | 100,000,000 | |||||||||||||||||||||
Undesignated preferred shares in issue | 0 | 0 | ||||||||||||||||||||
Series A Convertible Preferred Shares | ||||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||||
Share consolidation basis nominal value per share | $ / shares | 0.01571 | |||||||||||||||||||||
Share consolidation basis, Renominalisation value per share | $ / shares | 0.01 | |||||||||||||||||||||
Temporary equity, shares authorized | 3,022,915 | 3,032,463 | 9,548 | |||||||||||||||||||
Temporary equity, par value | $ / shares | $ 0.01 | $ 0.001 | 0.0001 | $ 0.01 | ||||||||||||||||||
Temporary equity, shares issued | 1,518,137 | 1,514,320 | 3,032,457 | |||||||||||||||||||
Temporary equity shares price per share | $ / shares | $ 15.71 | $ 15.71 | ||||||||||||||||||||
Gross cash proceeds from Issuance of convertible preferred stock | $ | $ 20,851 | $ 20,701 | ||||||||||||||||||||
Series A Convertible Preferred Shares | Founders | ||||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||||
Conversion of debt amount | $ | $ 90 | |||||||||||||||||||||
Convertible preferred stock issued upon conversion | 5,728 | |||||||||||||||||||||
Series A Convertible Preferred Shares | Pfizer License Agreement | ||||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||||
Temporary equity, shares issued | 190,961 | |||||||||||||||||||||
Temporary equity, additional shares issued | 190,961 | |||||||||||||||||||||
Series B-1 Convertible Preferred Shares | ||||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||||
Share consolidation basis nominal value per share | $ / shares | 0.01571 | |||||||||||||||||||||
Share consolidation basis, Renominalisation value per share | $ / shares | $ 0.01 | |||||||||||||||||||||
Temporary equity, shares authorized | 2,654,215 | |||||||||||||||||||||
Temporary equity, par value | $ / shares | $ 0.01 | |||||||||||||||||||||
Temporary equity, shares issued | 2,654,206 | |||||||||||||||||||||
Temporary equity shares price per share | $ / shares | $ 17.28 | |||||||||||||||||||||
Gross cash proceeds from Issuance of convertible preferred stock | $ | $ 45,867 | |||||||||||||||||||||
Series B-2 Convertible Preferred Shares | ||||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||||
Temporary equity, shares authorized | 2,147,278 | 1,042,728 | ||||||||||||||||||||
Temporary equity, par value | $ / shares | $ 0.01 | $ 0.01 | ||||||||||||||||||||
Temporary equity, shares issued | 1,709,650 | |||||||||||||||||||||
Temporary equity shares price per share | $ / shares | $ 18.85 | |||||||||||||||||||||
Gross cash proceeds from Issuance of convertible preferred stock | $ | $ 32,230 | |||||||||||||||||||||
Series B Convertible Preferred Shares | ||||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||||
Temporary equity, shares authorized | 4,801,493 | |||||||||||||||||||||
Temporary equity, par value | $ / shares | $ 0.001 | $ 0.0001 | ||||||||||||||||||||
Temporary equity, shares issued | 4,363,856 | |||||||||||||||||||||
Supplier | ||||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||||
Common stock, maximum shares authorized for subscription | 700,000 | 700,000 | ||||||||||||||||||||
Common stock, shares subscribed but unissued | 199,056 | 199,056 | 245,493 | 245,493 | 17,222 | 17,222 | 190,615 | 190,615 | ||||||||||||||
Issuance of ordinary shares under subscription agreement | $ | $ 1,260 | $ 1,670 | $ 110 | $ 1,360 | ||||||||||||||||||
Payment receivable upon common stock subscription agreement | $ 1,260 | € 1,150 | $ 1,670 | € 1,500 | $ 110 | € 100 | $ 1,360 | € 1,200 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) | Dec. 05, 2018 | Oct. 14, 2016 | Oct. 14, 2015 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Mar. 14, 2018 | Mar. 13, 2018 | May 18, 2017 | Dec. 31, 2016 | Nov. 18, 2015 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Ordinary shares, shares issued | 413,110 | 14,868,973 | 14,352,046 | 413,110 | |||||||
Share options granted | 512,778 | 479,986 | 198,798 | ||||||||
Weighted average grant date fair value, options granted | $ 3.80 | $ 7.25 | $ 1.91 | ||||||||
Restricted Ordinary Shares | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Shares issued in the period | 413,110 | ||||||||||
Percentage of remaining restricted ordinary shares vest on monthly basis | 0.0278% | ||||||||||
Grant date fair value | $ 3.14 | $ 3.14 | $ 3.14 | $ 3.14 | $ 3.14 | ||||||
Expense recognized | $ 260,000 | $ 332,000 | $ 333,000 | ||||||||
Unamortized stock compensation expense | $ 0 | $ 260,000 | $ 592,000 | ||||||||
Stock-based compensation expense, expected weighted average period for recognition | 9 months 14 days | 1 year 9 months 14 days | |||||||||
Restricted Ordinary Shares | Tranche One | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Percentage of awards vested | 25.00% | ||||||||||
Employee Stock Options | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Risk-free interest rate based on estimate of U.S. treasury yield | 7 years | ||||||||||
Employees and Directors | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Expense recognized | $ 1,388,000 | $ 669,000 | $ 59,000 | ||||||||
Vesting period | 2 years 7 months 9 days | 3 years 25 days | 3 years 6 months 3 days | ||||||||
Share options granted | 512,778 | 479,986 | 198,798 | ||||||||
Unvested employee options outstanding | 837,386 | 566,813 | 228,809 | ||||||||
Unamortized compensation expense share options | $ 3,342,000 | $ 2,822,000 | $ 396,000 | ||||||||
Restricted Share Units (RSUs) | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Grant date fair value | $ 7.01 | $ 13 | |||||||||
Expense recognized | $ 313,000 | $ 289,000 | |||||||||
Unamortized stock compensation expense | $ 99,000 | $ 191,000 | |||||||||
Stock-based compensation expense, expected weighted average period for recognition | 5 months 12 days | 4 months 24 days | |||||||||
Number of shares, granted/awarded | 31,367 | 36,924 | |||||||||
Restricted Share Units (RSUs) | Director | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Vesting period | 1 year | ||||||||||
Number of shares, granted/awarded | 31,367 | 36,924 | 0 | ||||||||
Performance RSUs | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Grant date fair value | $ 8.21 | ||||||||||
Expense recognized | $ 212,000 | ||||||||||
Unamortized stock compensation expense | $ 198,000 | ||||||||||
Stock-based compensation expense, expected weighted average period for recognition | 9 months 21 days | ||||||||||
Number of shares, granted/awarded | 50,000 | 0 | |||||||||
Restricted Ordinary Shares, Options and Restricted Share Units and Performance Restricted Share Units | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Vesting period | 2 years 5 months 8 days | 2 years 8 months 15 days | 2 years 6 months 10 days | ||||||||
Unamortized compensation expense | $ 3,639,000 | $ 3,273,000 | $ 988,000 | ||||||||
2015 Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Number of shares authorized | 223,424 | ||||||||||
Number of ordinary shares available for issuance | 443,029 | 219,605 | |||||||||
2018 Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Number of shares authorized | 1,018,459 | ||||||||||
Increase in number of ordinary shares available to be granted, percentage | 4.00% | ||||||||||
Ordinary shares, shares issued | 574,081 | ||||||||||
2015 Plan and 2018 Plan | Employee Stock Options | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share option granted term | 10 years | ||||||||||
Vesting period | 4 years | ||||||||||
Vesting rights | The vesting requirement is conditioned upon a grantee’s continued service with the Company during the vesting period. Once vested, all awards are exercisable from the date of grant until they expire. The option grants are non-transferable. Vested options generally remain exercisable for 90 days subsequent to the termination of the option holder’s service with the Company. In the event of an option holder’s disability or death while employed by or providing service to the Company, the exercisable period extends to twelve months or eighteen months, respectively. |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Restricted Ordinary Share Activity and Related Information (Details) - Restricted Ordinary Shares - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Shares | |||
Number of Shares, Unvested, Beginning balance | 86,068 | 189,342 | 292,620 |
Number of Shares, Vested | (86,068) | (103,274) | (103,278) |
Number of Shares, Unvested, Ending balance | 86,068 | 189,342 | |
Weighted Average grant date fair value per share | |||
Weighted Average grant date fair value per share, Unvested, Beginning balance | $ 3.14 | $ 3.14 | $ 3.14 |
Weighted Average grant date fair value per share, Vested | 3.14 | 3.14 | 3.14 |
Weighted Average grant date fair value per share, Unvested, Ending balance | $ 3.14 | $ 3.14 | $ 3.14 |
Share-Based Compensation - Sche
Share-Based Compensation - Schedule of Assumptions Used to Determine Grant Date Fair Value of Employee and Director Options Granted (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Volatility | 60.00% | 60.00% | |
Volatility, minimum | 68.90% | ||
Volatility, maximum | 74.50% | ||
Expected term in years | 6 years 3 months | 6 years 3 months | |
Dividend rate | 0.00% | 0.00% | 0.00% |
Risk-free interest rate | 1.63% | ||
Risk-free interest rate, minimum | 1.73% | 2.16% | |
Risk-free interest rate, maximum | 2.57% | 2.91% | |
Minimum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term in years | 5 years 6 months | ||
Share price | $ 3.55 | $ 7.06 | $ 3.30 |
Fair value of option on grant date | $ 2.37 | 4.41 | 1.88 |
Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term in years | 6 years 3 months | ||
Share price | $ 6.80 | 13 | 4.40 |
Fair value of option on grant date | $ 4.41 | $ 7.49 | $ 2.50 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Number of Options Outstanding and Weighted-average Exercise Price (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Compensation Related Costs [Abstract] | ||||
Number of Shares, Options outstanding Beginning Balance | 665,219 | 248,128 | 49,330 | |
Number of Shares, Granted | 512,778 | 479,986 | 198,798 | |
Number of Shares, Exercised | (18,232) | (2,008) | ||
Number of Shares, Forfeited | (8,726) | (60,887) | ||
Number of Shares, Expired | (769) | |||
Number of Shares, Options outstanding Ending Balance | 1,150,270 | 665,219 | 248,128 | 49,330 |
Number of Shares, Exercisable at December 31, 2019 | 312,884 | |||
Weighted Average Exercise Price, Options outstanding Beginning Balance | $ 9.31 | $ 3.31 | $ 3.14 | |
Weighted Average Exercise Price, Granted | 5.94 | 12.60 | 3.36 | |
Weighted Average Exercise Price, Exercised | 3.29 | 3.30 | ||
Weighted Average Exercise Price, Forfeited | 7.43 | 10.99 | ||
Weighted Average Exercise Price, Expired | 6.77 | |||
Weighted Average Exercise Price, Options outstanding Ending Balance | 7.92 | $ 9.31 | $ 3.31 | $ 3.14 |
Weighted Average Exercise Price, Exercisable at December 31, 2019 | $ 8.82 | |||
Weighted Average Remaining Contractual Life in Years, Options outstanding | 8 years 7 months 2 days | 8 years 11 months 4 days | 9 years 5 months 8 days | 8 years 6 months 3 days |
Weighted Average Remaining Contractual Life in Years, Exercisable at December 31, 2019 | 8 years 7 days | |||
Aggregate Intrinsic Value, Options outstanding | $ 395 | |||
Aggregate Intrinsic Value, Options outstanding | 254 | $ 395 | ||
Aggregate Intrinsic Value, Exercisable at December 31, 2019 | $ 157 |
Share-Based Compensation - Su_3
Share-Based Compensation - Summary of Number of RSUs Granted and Weighted-average Grant Date Fair Value of RSUs (Details) - Restricted Share Units (RSUs) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Unvested, Beginning balance | 36,924 | |
Number of Shares, Granted | 31,367 | 36,924 |
Number of Shares, Vested | (36,924) | |
Number of Shares, Unvested, Ending balance | 31,367 | 36,924 |
Weighted Average grant date fair value per share, Unvested, Beginning balance | $ 13 | |
Weighted Average grant date fair value per share, Granted | 7.01 | $ 13 |
Weighted Average grant date fair value per share, Vested | 13 | |
Weighted Average grant date fair value per share, Unvested, Ending balance | $ 7.01 | $ 13 |
Share-Based Compensation - Su_4
Share-Based Compensation - Summary of Number of Performance RSUs Granted and Weighted-average Grant Date Fair Value of PSUs (Details) - Performance RSUs - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Granted | 50,000 | 0 |
Number of Shares, Unvested, Ending balance | 50,000 | |
Weighted Average grant date fair value per share, Granted | $ 8.21 | |
Weighted Average grant date fair value per share, Unvested, Ending balance | $ 8.21 |
Share-Based Compensation - Su_5
Share-Based Compensation - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Research and Development Expense | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 723 | $ 398 | $ 139 |
General and Administrative Expense | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 1,450 | $ 892 | $ 253 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | |||
Income tax benefits | $ 0 | $ 0 | $ 0 |
U.S. Tax Authority | |||
Income Tax [Line Items] | |||
Federal statutory tax rate | 21.00% | 21.00% | 34.00% |
Ireland | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards | $ 26,195,000 | $ 13,648,000 | $ 5,409,000 |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Current | |||
U.S. | $ 444 | $ 472 | $ 444 |
Total Current | 444 | 472 | 444 |
Deferred | |||
Income Tax Provision | $ 444 | $ 472 | $ 444 |
Income Taxes - Summary of Com_2
Income Taxes - Summary of Components of Income (Loss) Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ 484 | $ 532 | $ 875 |
Ireland | (103,170) | (77,116) | (29,837) |
Total | $ (102,686) | $ (76,584) | $ (28,962) |
Income Taxes - Summary of Effec
Income Taxes - Summary of Effective Income Tax Rate (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | |||
Impact of U.S. tax rate, Percentage | (0.07%) | (0.11%) | (0.80%) |
Impact of valuation allowance, Percentage | (12.91%) | (11.42%) | (13.64%) |
Research and development tax credit, Percentage | 0.23% | 0.45% | 0.76% |
Adjustments for current tax of prior periods, Percentage | (0.24%) | 0.00% | 0.00% |
Other, net, Percentage | 0.06% | (2.03%) | (0.36%) |
Effective tax rate, Percentage | (0.43%) | (0.61%) | (1.54%) |
Statutory rate, Amount | $ (12,836) | $ (9,573) | $ (3,620) |
Impact of U.S. tax rate, Amount | 72 | 81 | 232 |
Impact of valuation allowance, Amount | 13,258 | 8,749 | 3,949 |
Research and development tax credit, Amount | (232) | (341) | (220) |
Adjustments for current tax of prior periods, Amount | 241 | ||
Other, net, Amount | (59) | 1,557 | 103 |
Income Tax Provision | $ 444 | $ 472 | $ 444 |
Ireland | |||
Income Tax [Line Items] | |||
Statutory rate, Percentage | 12.50% | 12.50% | 12.50% |
Income Taxes - Summary of Signi
Income Taxes - Summary of Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets | |||
Share-based compensation | $ 679 | $ 27 | $ 3 |
Depreciation | (24) | (49) | |
Depreciation | 6 | ||
Net operating loss carryforwards | 26,195 | 13,648 | 5,409 |
163(j) interest expense limitation | 730 | 115 | |
Other | 84 | 665 | 239 |
Valuation allowance | $ (27,664) | $ (14,406) | $ (5,657) |
Income Taxes - Summary of Gross
Income Taxes - Summary of Gross Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Balance at January 1 | $ 428 | $ 30 |
Additions | 2,033 | 398 |
Balance at December 31 | $ 2,461 | $ 428 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) € in Thousands | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2018EUR (€) | Jun. 30, 2016USD ($) | Jun. 30, 2016EUR (€) | Nov. 18, 2015USD ($) |
Other Commitments [Line Items] | |||||||
Purchase obligation | $ 0 | $ 1,604,000 | $ 2,807,000 | € 2,500 | |||
Pfizer License Agreement | Minimum | |||||||
Other Commitments [Line Items] | |||||||
Potential future regulatory milestone and sales milestone payments upon achievement of net sales | $ 250,000,000 | ||||||
Pfizer License Agreement | Maximum | |||||||
Other Commitments [Line Items] | |||||||
Potential future regulatory milestone and sales milestone payments upon achievement of net sales | $ 1,000,000,000 | ||||||
Supplemental Agreement | |||||||
Other Commitments [Line Items] | |||||||
Purchase obligation | $ 2,301,000 | € 2,050 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | Apr. 27, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | |||
Accretion of debt discounts and deferred financing costs | $ 362,000 | $ 360,000 | |
Ordinary Shares | |||
Debt Instrument [Line Items] | |||
Number of warrants to purchase preferred shares | 19,890 | ||
Loan and Security Agreement | Silicon Valley Bank (SVB) | |||
Debt Instrument [Line Items] | |||
Loan and security agreement entered date | Apr. 27, 2018 | ||
Funded amount under agreement | $ 15,000,000 | ||
Remaining borrowing facility available date | Oct. 31, 2019 | ||
Maximum amount available under agreement | $ 30,000,000 | ||
Non-utilization fee percentage of undrawn principal amount | 1.50% | ||
Frequency of amortization payments | Monthly | ||
Date of first required payment of initial draw | Nov. 1, 2019 | ||
Minimum fixed interest rate per annum | 8.31% | ||
Final interest rate payment on outstanding principal | 4.20% | ||
Principal and interest payment, maturity date | Mar. 1, 2022 | ||
Final payment fee | $ 630,000 | ||
Prepayment fee in first year | 4.00% | ||
Prepayment fee in second year | 3.00% | ||
Prepayment fee thereafter | 2.00% | ||
Principal payment during the period | $ 1,034,000 | ||
Effective annual interest rate on outstanding debt | 11.28% | ||
Interest expense | $ 1,761,000 | $ 1,169,000 | |
Accretion of debt discounts and deferred financing costs | $ 362,000 | $ 360,000 | |
Loan and Security Agreement | Silicon Valley Bank (SVB) | Wall Street Journal Prime Rate | |||
Debt Instrument [Line Items] | |||
Basis spread on interest rate | 3.89% | ||
Loan and Security Agreement | Silicon Valley Bank (SVB) | Maximum | |||
Debt Instrument [Line Items] | |||
Maximum amount available under second draw | $ 15,000,000 | ||
Silicon Valley Bank and Life Sciences Fund II LLC | |||
Debt Instrument [Line Items] | |||
Percentage of purchase additional ordinary shares equal to term loan divided by applicable exercise price | 2.50% | ||
Silicon Valley Bank and Life Sciences Fund II LLC | Series B Convertible Preferred Shares | |||
Debt Instrument [Line Items] | |||
Number of warrants to purchase preferred shares | 19,890 | ||
Warrants to purchase preferred shares, exercise price | $ 18.85 |
Debt - Schedule of Principal Pa
Debt - Schedule of Principal Payments on Outstanding Debt (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Debt Disclosure [Abstract] | |
2020 | $ 6,207 |
2021 | 6,207 |
2022 | 1,552 |
Long-term Debt | $ 13,966 |
Quarterly Financial Data (Una_3
Quarterly Financial Data (Unaudited) - Schedule of Unaudited Quarterly Financial Data (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 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 37 | $ 239 | $ 254 | $ 185 | $ 191 | $ 37 | $ 869 | $ 508 | |||
Total operating expenses | $ (23,178) | $ (30,999) | $ (27,378) | (20,503) | (24,183) | (25,240) | (15,611) | (12,394) | (102,058) | (77,428) | (29,963) |
Net loss | (23,641) | (31,271) | (27,638) | (20,580) | (24,258) | (24,905) | (15,747) | (12,146) | (103,130) | (77,056) | (29,406) |
Net loss attributable to ordinary shareholders | $ (23,641) | $ (31,271) | $ (27,638) | $ (20,580) | $ (24,258) | $ (24,905) | $ (15,747) | $ (12,146) | $ (103,130) | $ (77,056) | $ (29,406) |
Net loss per share attributable to ordinary shareholders – basic and diluted | $ (1.59) | $ (2.15) | $ (1.93) | $ (1.44) | $ (1.72) | $ (1.77) | $ (2.22) | $ (61.36) | $ (7.10) | $ (8.82) | $ (170.84) |
Weighted average ordinary shares outstanding – basic and diluted | 14,866,838 | 14,571,278 | 14,340,231 | 14,290,437 | 14,108,604 | 14,034,631 | 7,085,655 | 197,949 | 14,518,036 | 8,734,109 | 172,130 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event | Jan. 21, 2020USD ($)Debtinstrumentshares |
Iterum Therapeutics Bermuda Limited | |
Subsequent Event [Line Items] | |
Ownership percentage | 100.00% |
Subsidiary Guarantors | |
Subsequent Event [Line Items] | |
Ownership percentage | 100.00% |
Private Placement | Exchangeable Notes | |
Subsequent Event [Line Items] | |
Aggregate principal amount | $ 51,600,000 |
Debt instrument price per unit | 1,000 |
Private Placement | RLNs | |
Subsequent Event [Line Items] | |
Aggregate principal amount | $ 100,000 |
Number of debt instruments within each notes | Debtinstrument | 50 |
Debt instrument, aggregate potential payment capped value | $ 160,000 |
Debt instrument, aggregate potential payment capped rate | 4,000 times |
Private Placement | Securities | |
Subsequent Event [Line Items] | |
Debt instrument price per unit | $ 1,000 |
Debt instrument, shares embedded within each unit, shares | shares | 1,000 |
Debt instrument, shares embedded within each unit, value | $ 1,000 |
Proceeds from sale of securities | $ 46,700,000 |
Minimum | Private Placement | RLNs | |
Subsequent Event [Line Items] | |
Debt instrument, percentage of net revenue from domestic sale for potential aggregate payments | 15.00% |
Maximum | Private Placement | RLNs | |
Subsequent Event [Line Items] | |
Debt instrument, percentage of net revenue from domestic sale for potential aggregate payments | 20.00% |