Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 30, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ITRM | |
Entity Registrant Name | Iterum Therapeutics plc | |
Entity Central Index Key | 0001659323 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 14,369,218 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 64,603 | $ 44,551 |
Short-term investments | 4,997 | 40,000 |
Prepaid expenses and other current assets | 7,188 | 8,390 |
Current portion of restricted cash | 30 | 30 |
Total current assets | 76,818 | 92,971 |
Property and equipment, net | 675 | 700 |
Restricted cash, less current portion | 90 | 90 |
Other assets | 11,551 | 4,110 |
Total assets | 89,134 | 97,871 |
Current liabilities: | ||
Accounts payable | 6,176 | 4,041 |
Accrued expenses | 8,696 | 7,046 |
Current portion of long-term debt | 2,056 | 1,019 |
Income taxes payable | 248 | 113 |
Other current liabilities | 442 | |
Total current liabilities | 17,618 | 12,219 |
Long-term debt, less current portion | 12,139 | 13,079 |
Other liabilities | 7,747 | 951 |
Total liabilities | 37,504 | 26,249 |
Commitments and contingencies (Note 12) | ||
Shareholders’ equity: | ||
Ordinary shares, $0.01 par value per share: 50,000,000 shares authorized at March 31, 2019 and December 31, 2018; 14,367,441 shares issued at March 31, 2019; 14,352,046 shares issued at December 31, 2018 | 144 | 144 |
Additional paid-in capital | 203,859 | 203,271 |
Accumulated deficit | (152,373) | (131,793) |
Total shareholders' equity | 51,630 | 71,622 |
Total liabilities and shareholders’ equity | $ 89,134 | $ 97,871 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Ordinary shares, par value | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized | 50,000,000 | 50,000,000 |
Ordinary shares, shares issued | 14,367,441 | 14,352,046 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Revenue | $ 37 | $ 191 |
Operating expenses: | ||
Research and development | (17,387) | (10,879) |
General and administrative | (3,116) | (1,515) |
Total operating expenses | (20,503) | (12,394) |
Operating loss | (20,466) | (12,203) |
Interest (expense) / income, net | (104) | 85 |
Other income, net | 124 | 61 |
Total other income | 20 | 146 |
Loss before income taxes | (20,446) | (12,057) |
Income tax expense | (134) | (89) |
Net loss and comprehensive loss | (20,580) | (12,146) |
Net loss attributable to ordinary shareholders | $ (20,580) | $ (12,146) |
Net loss per share attributable to ordinary shareholders – basic and diluted | $ (1.44) | $ (61.36) |
Weighted average ordinary shares outstanding – basic and diluted | 14,290,437 | 197,949 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Cash flows from operating activities: | |||
Net loss | $ (20,580) | $ (12,146) | |
Adjustments to reconcile net loss to cash used in operating activities: | |||
Depreciation | 35 | 31 | $ 136 |
Share-based compensation expense | 540 | 149 | |
Gain on short term investments | (88) | ||
Non-cash gain on short term investments | (9) | (23) | |
Interest on short-term investments | (11) | ||
Amortization of SVB loan | 98 | ||
Other | 29 | ||
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | 1,193 | (793) | |
Other assets | (191) | (52) | |
Accounts payable | 2,135 | 422 | |
Accrued expenses | 1,662 | 692 | |
Income taxes | 134 | 82 | |
Other liabilities | (2) | ||
Net cash used in operating activities | (15,053) | (11,640) | |
Cash flows from investing activities: | |||
Purchases of property and equipment | (10) | (21) | |
Purchases of short-term investments | (6,372) | ||
Proceeds from sale of short-term investments | 35,100 | 15,750 | |
Net cash generated by investing activities | 35,090 | 9,357 | |
Cash flows from financing activities: | |||
Proceeds from exercise of shares options | 49 | ||
Net cash provided by financing activities | 49 | 32,176 | |
Effect of exchange rates on cash and cash equivalents | (34) | ||
Net increase in cash, cash equivalents and restricted cash | 20,052 | 29,893 | |
Cash, cash equivalents and restricted cash, at beginning of period | 44,671 | 8,485 | 8,485 |
Cash, cash equivalents and restricted cash, at end of period | 64,723 | 38,378 | $ 44,671 |
Supplemental Disclosure of Cash Flow Information: | |||
Interest paid | $ 350 | ||
Series B Convertible Preferred Shares | |||
Cash flows from financing activities: | |||
Proceeds from issuance of Series B convertible preferred shares, net of issuance costs | $ 32,176 |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | 1. Basis of Presentation Iterum Therapeutics plc (the “Company”) was incorporated under the laws of the state 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) and a sub-award from the Trustees of Boston University under the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) program . 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 condensed 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. 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 incurred operating losses since inception, including net losses of $20,580 and $12,146 for the three months ended March 31, 2019 and 2018, respectively, and a net loss of $77,056 for the year ended December 31, 2018. The Company had an accumulated deficit of $152,373 as of March 31, 2019. The Company expects to continue to incur net losses for the foreseeable future and is highly dependent on its ability to find additional sources of funding in the form of debt or equity financing to fund its operations. Management believe that its cash and cash equivalents balance of $64,603 and short-term investments balance of $4,997 at March 31, 2019, together with the $15.0 million potentially available under the secured credit facility with SVB, are sufficient to fund operations for at least one year from the date the condensed consolidated financial statements are issued. In making this assessment management have considered the Company’s available cash resources, future financing options available to the Company, the planned operations of the Company and the ability to adjust its plans if required. The $15.0 million under the secured credit facility with SVB will be available to the Company through October 31, 2019, upon satisfaction of either (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. The inability to obtain funding, as and when needed, would have a negative impact on the Company’s financial condition and ability to pursue its business strategies. If the Company is unable to obtain funding, the Company 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. The Company expects to seek additional funding in order to continue to fund its operations through public or private financing of debt or equity or collaboration agreements. Although management intends to pursue plans to obtain additional funding to finance its operations, 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. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the condensed 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. Interim Financial Information The condensed consolidated balance sheet at December 31, 2018 was derived from audited financial statements, but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of March 31, 2019, have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2018, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2019. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of March 31, 2019, and results of operations for the three months ended March 31, 2019 and 2018, and cash flows for the three months ended March 31, 2019 and 2018 have been made. The results of operations for the three months ended March 31, 2019 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2019. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies, other than the adoption of accounting pronouncements below, as compared to the significant accounting policies described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. 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 condensed consolidated financial statements include, but are not limited to, the accrual for research and development expenses, revenue from grant awards, 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. 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 Accounting Standard Codification (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: Three Months Ended March 31, 2019 March 31, 2018 Options to purchase ordinary shares 1,091,238 248,128 Preferred shares convertible into ordinary shares — 7,396,313 Unvested restricted ordinary shares 60,250 163,523 Unvested restricted share units 36,924 — Unvested performance restricted share units 50,000 — Warrants 19,890 — Total 1,258,302 7,807,964 Segment 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: Three Months Ended Operating expenses March 31, 2019 March 31, 2018 Ireland $ 17,436 $ 9,964 U.S. 3,067 $ 2,430 Total $ 20,503 $ 12,394 The distribution of long-lived assets by geographical area was as follows: Long lived assets March 31, 2019 December 31, 2018 Ireland $ 9,970 $ 4,565 U.S. 2,256 245 Total $ 12,226 $ 4,810 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 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 condensed consolidated financial statements. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 3 Months Ended |
Mar. 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 condensed consolidated balance sheet as of March 31, 2019 and December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value. March 31, 2019 Assets Total Level 1 Level 2 Level 3 Short-term investments $ 4,997 $ 4,997 — — Other asset – advance payment to supplier 2,617 — — 2,617 Total $ 7,614 4,997 — 2,617 December 31, 2018 Assets Total Level 1 Level 2 Level 3 Short-term investments $ 40,000 40,000 — — Other asset – advance payment to supplier 2,649 — — 2,649 Total $ 42,649 40,000 — 2,649 See Note 4 for further details on the short-term investments held. The other asset above relates to advance payments made to a supplier that were recorded at fair value using the discounted cash flow model (DCF) as of March 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, for further details on these advance payments. The following table presents information about the Company’s long-term debt which was carried at amortized cost on the condensed consolidated balance sheet as of March 31, 2019 and December 31, 2018 March 31, 2019 Approximate Liabilities Book Value Fair Value Level 1 Level 2 Level 3 Current portion of long-term debt $ 2,056 $ 2,056 — 2,056 — Long-term debt, less current portion 12,139 11,850 — 11,850 — Total $ 14,195 $ 13,906 — 13,906 — 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 condensed 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 | 3 Months Ended |
Mar. 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 and as at period-end consist of corporate entity commercial paper with maturities of more than three months but less than one year at the date of purchase. Short-term investments as of March 31, 2019 have an average maturity of 0.12 years. The investments are reported at fair value with unrealized gains or losses recorded in the condensed 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 value of short-term investments are represented by Level 1 fair value measurements – quoted prices in active markets for identical assets. The following table represents the Company’s available for sale short-term investments by major security type as of March 31, 2019 and December 31, 2018: March 31, 2019 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 $ 4,986 11 — 4,997 4,997 — 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 | 3 Months Ended |
Mar. 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: March 31, 2019 December 31, 2018 Prepaid research and development expenses $ 5,315 $ 5,351 Short-term deposits 873 959 Research and development tax credit receivable 395 404 Prepaid insurance 245 438 Interest receivable 151 158 Other prepaid assets 141 921 Value added tax receivable 68 159 Total $ 7,188 $ 8,390 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 6. Property and Equipment Property and equipment and related accumulated depreciation are as follows: March 31, 2019 December 31, 2018 Leasehold improvements $ 592 $ 592 Furniture and fixtures 120 120 Laboratory equipment 81 81 Computer equipment 118 108 911 901 Less: accumulated depreciation (236 ) (201 ) $ 675 $ 700 Depreciation expense was $35 for the three months ended March 31, 2019 and $136 for the year ended December 31, 2018. |
Leases
Leases | 3 Months Ended |
Mar. 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 six 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 have 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 have 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 expense is recognized on a straight-line basis over the lease term. The Company recognized $254 of operating lease costs for right-of-use assets during the three months ended March 31, 2019. Information related to the Company’s right-of-use assets and related lease liabilities is as follows: Three Months Ended March 31, 2019 Cash paid for operating lease liabilities $ 190 Right-of-use assets obtained in exchange for new operating lease obligation (1) $ 7,622 Weighted-average remaining lease term 13.2 years Weighted-average discount rate 7.6 % (1) All operating leases included above were held at January 1, 2019 Right-of-use assets and lease liabilities for the Company’s operating leases were recorded in the condensed 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”): March 31, 2019 Other assets $ 7,504 Other current liabilities $ 442 Other liabilities 7,117 Total lease liabilities $ 7,559 Future lease payments included in the measurement of lease liabilities on the condensed consolidated balance sheet as of March 31, 2019, for the following five fiscal years and thereafter were as follows: Due in 12 month period ended March 31, 2020 $ 982 2021 1,017 2022 1,022 2023 1,033 2024 1,038 Thereafter 6,420 $ 11,512 Less imputed interest (3,953 ) Total lease liabilities $ 7,559 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 | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 8. Accrued Expenses Accrued expenses consist of the following: March 31, 2019 December 31, 2018 Accrued clinical trial costs $ 6,383 $ 2,849 Accrued manufacturing expenses 859 1,439 Accrued other expenses 843 954 Accrued payroll and bonus expenses 611 1,804 Total $ 8,696 $ 7,046 |
Shareholders' Equity
Shareholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Shareholders’ Equity | 9. Shareholders’ Equity The following tables present a reconciliation of our beginning and ending balances in shareholders’ equity for the three months ended March 31, 2019 and 2018: Total Shareholders' Equity Shareholders' equity at January 1, 2019 $ 71,622 Exercise of share options 48 Share-based compensation expense 540 Net loss (20,580 ) Shareholders' equity at March 31, 2019 $ 51,630 Total Shareholders' Equity Shareholders' equity at January 1, 2018 $ 39,494 Issuance of Series B convertible preferred shares, net 32,159 Share-based compensation expense 149 Net loss (12,146 ) Shareholders' equity at March 31, 2018 $ 59,656 |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 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 our IPO in May 2018. 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, adopted and approved on March 14, 2018, authorized 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 1/36th of the remaining restricted ordinary shares vest on a monthly basis thereafter (subject to acceleration of vesting in connection with certain change of control transactions). A change in status occurred on November 18, 2015 when the founders became employees of the Company. The grant date of these shares is now considered to be November 18, 2015 when the fair value was $3.14 per share. 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 $85 and $82 for the three months ended March 31, 2019 and 2018, respectively. Total unamortized compensation expense related to restricted ordinary shares was $175 and $510 as of March 31, 2019 and March 31, 2018, respectively, expected to be recognized over a weighted average period of 0.54 years and 1.54 years as of March 31, 2019 and March 31, 2018, respectively. The following table summarizes restricted ordinary shares activity for the three months ended March 31, 2019: Number of Shares Weighted Average Grant Date Fair Value per Share Unvested at December 31, 2018 86,068 $ 3.14 Granted — Vested (25,818 ) $ 3.14 Forfeited — Unvested at March 31, 2019 (unaudited) 60,250 $ 3.14 Share Options The Company granted 442,500 share options to employees and directors during the three months ended March 31, 2019. The Company awarded 74,152 share options to employees during the These options were granted and priced upon execution of the underwriting agreement related to the IPO in May 2018. The assumptions that the Company used to determine the grant date fair value of employee and director options granted were as follows, presented on a weighted average basis: Three Months Ended March 31, 2019 2018 Volatility 69.5% - 70.2% 60% Expected term in years 6.25 6.25 Dividend rate 0% 0% Risk-free interest rate 2.44% - 2.57% 1.63% Share price $5.80 - $6.80 — Fair value of option on grant date $3.74 - $4.41 — 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, 2018 665,219 $ 9.31 8.93 395 Granted 442,500 5.82 Exercised (15,395 ) 3.16 Forfeited (1,086 ) 9.44 Options outstanding March 31, 2019 1,091,238 $ 7.98 9.27 1,956 Exercisable at March 31, 2019 (unaudited) 106,325 $ 4.59 8.25 425 Restricted share units (RSUs) No RSUs were awarded to directors during the three months ended March 31, 2019. No RSUs were awarded or outstanding during the three months ended March 31, 2018. The table below shows the number of RSUs granted covering an equal number of our 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, 2018 36,924 $ 13.00 Granted — Shares vested — Forfeited — RSUs outstanding March 31, 2019 36,924 $ 13.00 The fair value of RSUs is determined on the date of grant based on the market price of our 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 $119 for the three months ended March 31, 2019. Total unamortized compensation expense related to RSUs was $72 as of March 31, 2019, which is expected to be recognized over a remaining average vesting period of 0.15 years as of March 31, 2019. The Company awarded 50,000 RSUs to certain employees during the three months ended March 31, 2019 which are subject to certain performance based vesting conditions (Performance RSUs). No Performance RSUs were awarded or outstanding during the three months ended March 31, 2018. The table below shows the number of Performance RSUs granted covering an equal number of our 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 March 31, 2019 50,000 $ 8.21 The weighted average grant date fair value of restricted share units 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 $29 for the three months ended March 31, 2019. Total unamortized compensation expense related to Performance RSUs was $381 as of March 31, 2019, which is expected to be recognized over approximately the next 1.56 years as of March 31, 2019. The Company’s share-based compensation expense was classified in the condensed consolidated statements of operations and comprehensive loss as follows: Three Months Ended March 31, 2019 2018 Research and development expense $ 163 $ 71 General and administrative expense 377 78 There was a total of $4,796 and $1,642 unamortized share-based compensation expense for restricted ordinary shares, options, restricted share units and performance restricted share units as of March 31, 2019 and March 31, 2018, respectively, which is expected to be recognized over a remaining average vesting period of 2.98 years and 2.32 years as of March 31, 2019 and March 31, 2018, respectively. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes In accordance with the FASB ASC Topic No. 270 “ Interim Reporting” “Income Taxes” (Topic No. 740) Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax bases of assets and liabilities using statutory rates. Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, including the Company’s history of losses and determined that it is more-likely-than-not that these net deferred tax assets will not be realized. As of March 31, 2019, and December 31, 2018, the Company has net operating loss carryforwards in Ireland of approximately $16,183 and $13,648, respectively, for which a full valuation allowance has been recognized. 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. |
Commitment and Contingencies
Commitment and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. 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 $2,805 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 $2,300 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. $1,571 and $1,604 remained outstanding to the supplier as of March 31, 2019 and December 31, 2018, respectively. 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 named 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 | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | 13. Debt On April 27, 2018, the Company’s subsidiaries, Iterum Therapeutics International Limited, Iterum Therapeutics US Holding Limited and Iterum Therapeutics US Limited (Borrowers) entered into a loan and security agreement with SVB pursuant to which SVB agreed to lend the Borrowers up to $30.0 million in two term loans. $15.0 million of the secured credit facility was funded on closing and the other $15.0 million is available at the Company’s option upon the satisfaction of either of the following conditions which are referred to as the Second Draw Conditions: (i) the achievement of both non-inferiority and superiority primary endpoints from the Company’s Phase 3 uUTI clinical trial and reporting satisfactory safety data; or (ii) the achievement of non-inferiority primary endpoints from both of the Company’s Phase 3 uUTI and cUTI clinical trials as well as reporting satisfactory safety data, in each case as determined by SVB at its sole discretion. The Company’s option to draw the second term loan will terminate upon the earliest to occur of October 31, 2019, the thirtieth day following the occurrence of either of the Second Draw Conditions, or the occurrence of an event of default. A non-utilization fee of 1.50% of the aggregate undrawn principal amount shall apply if the Company satisfies the Second Draw Conditions but chooses not to draw down the second term loan. The principal borrowed under the secured credit facility bears interest 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, which interest is payable monthly in arrears. The initial draw requires monthly amortization payments commencing November 1, 2019, which will be extended to April 1, 2020 if the second draw is made. All outstanding principal, plus a 4.2% final payment fee, will be due and payable on the earliest to occur of March 1, 2022 (Maturity Date), the acceleration of either term loan or the prepayment of either term loan. The final payment fee of $0.6 million, which represents 4.2% of the funded loan, is accreted using the effective interest method over the life of the loan as interest expense. The secured credit facility draws are subject to prepayment fees of 3.00% in the first year, 2.00% in the second year and 1.00% thereafter in the event of prepayment at any time prior to the Maturity Date. In connection with the initial $15.0 million draw, the Company issued to SVB and Life Sciences Fund II LLC (LSF) warrants to purchase an aggregate of 19,890 Series B-2 preferred shares (which converted to ordinary shares upon the Company’s IPO) at an exercise price of $18.85 per share. If the Company draws down the second term loan, each of SVB and LSF will be entitled, pursuant to additional share warrants issued to each of them at closing, to purchase such number of additional ordinary shares in an aggregate amount equal to 2.5% of the funded amount, divided by the applicable exercise price. Obligations under the secured credit facility are secured by substantially all of the Company’s existing and future assets and the existing and future assets of the Company’s subsidiaries, including intellectual property. 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 11.4%. For the three months ended March 31, 2019, the Company recognized $448 of interest expense related to the loan agreement, including $98 related to the accretion of the debt discounts and deferred financing costs. Scheduled principal payments on outstanding debt, as of March 31, 2019, are as follows: Year Ending December 31, 2019 (remaining) 1,034 2020 6,207 2021 6,207 2022 1,552 2022 $ 15,000 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events There have been no events subsequent to the period end that would require adjustment to, or disclosure in, this Quarterly Report on Form 10-Q. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 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 incurred operating losses since inception, including net losses of $20,580 and $12,146 for the three months ended March 31, 2019 and 2018, respectively, and a net loss of $77,056 for the year ended December 31, 2018. The Company had an accumulated deficit of $152,373 as of March 31, 2019. The Company expects to continue to incur net losses for the foreseeable future and is highly dependent on its ability to find additional sources of funding in the form of debt or equity financing to fund its operations. Management believe that its cash and cash equivalents balance of $64,603 and short-term investments balance of $4,997 at March 31, 2019, together with the $15.0 million potentially available under the secured credit facility with SVB, are sufficient to fund operations for at least one year from the date the condensed consolidated financial statements are issued. In making this assessment management have considered the Company’s available cash resources, future financing options available to the Company, the planned operations of the Company and the ability to adjust its plans if required. The $15.0 million under the secured credit facility with SVB will be available to the Company through October 31, 2019, upon satisfaction of either (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. The inability to obtain funding, as and when needed, would have a negative impact on the Company’s financial condition and ability to pursue its business strategies. If the Company is unable to obtain funding, the Company 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. The Company expects to seek additional funding in order to continue to fund its operations through public or private financing of debt or equity or collaboration agreements. Although management intends to pursue plans to obtain additional funding to finance its operations, 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. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the condensed 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. |
Interim Financial Information | Interim Financial Information The condensed consolidated balance sheet at December 31, 2018 was derived from audited financial statements, but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of March 31, 2019, have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2018, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2019. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of March 31, 2019, and results of operations for the three months ended March 31, 2019 and 2018, and cash flows for the three months ended March 31, 2019 and 2018 have been made. The results of operations for the three months ended March 31, 2019 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2019. |
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 condensed consolidated financial statements include, but are not limited to, the accrual for research and development expenses, revenue from grant awards, 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. |
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 Accounting Standard Codification (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: Three Months Ended March 31, 2019 March 31, 2018 Options to purchase ordinary shares 1,091,238 248,128 Preferred shares convertible into ordinary shares — 7,396,313 Unvested restricted ordinary shares 60,250 163,523 Unvested restricted share units 36,924 — Unvested performance restricted share units 50,000 — Warrants 19,890 — Total 1,258,302 7,807,964 |
Segment Information | Segment 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: Three Months Ended Operating expenses March 31, 2019 March 31, 2018 Ireland $ 17,436 $ 9,964 U.S. 3,067 $ 2,430 Total $ 20,503 $ 12,394 The distribution of long-lived assets by geographical area was as follows: Long lived assets March 31, 2019 December 31, 2018 Ireland $ 9,970 $ 4,565 U.S. 2,256 245 Total $ 12,226 $ 4,810 |
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 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 condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
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: Three Months Ended March 31, 2019 March 31, 2018 Options to purchase ordinary shares 1,091,238 248,128 Preferred shares convertible into ordinary shares — 7,396,313 Unvested restricted ordinary shares 60,250 163,523 Unvested restricted share units 36,924 — Unvested performance restricted share units 50,000 — Warrants 19,890 — Total 1,258,302 7,807,964 |
Schedule of Distribution of Total Operating Expenses by Geographical Area | The distribution of total operating expenses by geographical area was as follows: Three Months Ended Operating expenses March 31, 2019 March 31, 2018 Ireland $ 17,436 $ 9,964 U.S. 3,067 $ 2,430 Total $ 20,503 $ 12,394 |
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 March 31, 2019 December 31, 2018 Ireland $ 9,970 $ 4,565 U.S. 2,256 245 Total $ 12,226 $ 4,810 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 3 Months Ended |
Mar. 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 condensed consolidated balance sheet as of March 31, 2019 and December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value. March 31, 2019 Assets Total Level 1 Level 2 Level 3 Short-term investments $ 4,997 $ 4,997 — — Other asset – advance payment to supplier 2,617 — — 2,617 Total $ 7,614 4,997 — 2,617 December 31, 2018 Assets Total Level 1 Level 2 Level 3 Short-term investments $ 40,000 40,000 — — Other asset – 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 Condensed Consolidated Balance Sheet | The following table presents information about the Company’s long-term debt which was carried at amortized cost on the condensed consolidated balance sheet as of March 31, 2019 and December 31, 2018 March 31, 2019 Approximate Liabilities Book Value Fair Value Level 1 Level 2 Level 3 Current portion of long-term debt $ 2,056 $ 2,056 — 2,056 — Long-term debt, less current portion 12,139 11,850 — 11,850 — Total $ 14,195 $ 13,906 — 13,906 — 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) | 3 Months Ended |
Mar. 31, 2019 | |
Available For Sale Securities [Abstract] | |
Schedule of Available for Sale Short-term Investments by Major Security Types | The following table represents the Company’s available for sale short-term investments by major security type as of March 31, 2019 and December 31, 2018: March 31, 2019 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 $ 4,986 11 — 4,997 4,997 — 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) | 3 Months Ended |
Mar. 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: March 31, 2019 December 31, 2018 Prepaid research and development expenses $ 5,315 $ 5,351 Short-term deposits 873 959 Research and development tax credit receivable 395 404 Prepaid insurance 245 438 Interest receivable 151 158 Other prepaid assets 141 921 Value added tax receivable 68 159 Total $ 7,188 $ 8,390 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 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: March 31, 2019 December 31, 2018 Leasehold improvements $ 592 $ 592 Furniture and fixtures 120 120 Laboratory equipment 81 81 Computer equipment 118 108 911 901 Less: accumulated depreciation (236 ) (201 ) $ 675 $ 700 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 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: Three Months Ended March 31, 2019 Cash paid for operating lease liabilities $ 190 Right-of-use assets obtained in exchange for new operating lease obligation (1) $ 7,622 Weighted-average remaining lease term 13.2 years Weighted-average discount rate 7.6 % (1) All operating leases included above were held at January 1, 2019 Right-of-use assets and lease liabilities for the Company’s operating leases were recorded in the condensed 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”): March 31, 2019 Other assets $ 7,504 Other current liabilities $ 442 Other liabilities 7,117 Total lease liabilities $ 7,559 |
Schedule of Future Lease Payments Included in Measurement of Lease Liabilities on Condensed Consolidated Balance Sheet | Future lease payments included in the measurement of lease liabilities on the condensed consolidated balance sheet as of March 31, 2019, for the following five fiscal years and thereafter were as follows: Due in 12 month period ended March 31, 2020 $ 982 2021 1,017 2022 1,022 2023 1,033 2024 1,038 Thereafter 6,420 $ 11,512 Less imputed interest (3,953 ) Total lease liabilities $ 7,559 |
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) | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: March 31, 2019 December 31, 2018 Accrued clinical trial costs $ 6,383 $ 2,849 Accrued manufacturing expenses 859 1,439 Accrued other expenses 843 954 Accrued payroll and bonus expenses 611 1,804 Total $ 8,696 $ 7,046 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Reconciliation of Beginning and Ending Balances in Shareholders' Equity | The following tables present a reconciliation of our beginning and ending balances in shareholders’ equity for the three months ended March 31, 2019 and 2018: Total Shareholders' Equity Shareholders' equity at January 1, 2019 $ 71,622 Exercise of share options 48 Share-based compensation expense 540 Net loss (20,580 ) Shareholders' equity at March 31, 2019 $ 51,630 Total Shareholders' Equity Shareholders' equity at January 1, 2018 $ 39,494 Issuance of Series B convertible preferred shares, net 32,159 Share-based compensation expense 149 Net loss (12,146 ) Shareholders' equity at March 31, 2018 $ 59,656 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Schedule of Assumptions Used to Determine Grant Date Fair Value of Employee and Director Options Granted | Error extracting Word content |
Summary of Restricted Ordinary Shares Activity | The following table summarizes restricted ordinary shares activity for the three months ended March 31, 2019: Number of Shares Weighted Average Grant Date Fair Value per Share Unvested at December 31, 2018 86,068 $ 3.14 Granted — Vested (25,818 ) $ 3.14 Forfeited — Unvested at March 31, 2019 (unaudited) 60,250 $ 3.14 |
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, 2018 665,219 $ 9.31 8.93 395 Granted 442,500 5.82 Exercised (15,395 ) 3.16 Forfeited (1,086 ) 9.44 Options outstanding March 31, 2019 1,091,238 $ 7.98 9.27 1,956 Exercisable at March 31, 2019 (unaudited) 106,325 $ 4.59 8.25 425 |
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 our 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, 2018 36,924 $ 13.00 Granted — Shares vested — Forfeited — RSUs outstanding March 31, 2019 36,924 $ 13.00 |
Summary of Share-based Compensation Expense | The Company’s share-based compensation expense was classified in the condensed consolidated statements of operations and comprehensive loss as follows: Three Months Ended March 31, 2019 2018 Research and development expense $ 163 $ 71 General and administrative expense 377 78 |
Performance RSU [Member} | |
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 our 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 March 31, 2019 50,000 $ 8.21 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Principal Payments on Outstanding Debt | Scheduled principal payments on outstanding debt, as of March 31, 2019, are as follows: Year Ending December 31, 2019 (remaining) 1,034 2020 6,207 2021 6,207 2022 1,552 2022 $ 15,000 |
Basis of Presentation - Additio
Basis of Presentation - Additional Information (Details) $ / shares in Units, $ in Thousands | Jun. 26, 2018USD ($)$ / sharesshares | May 30, 2018USD ($)$ / sharesshares | May 15, 2018$ / shares | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Oct. 31, 2019USD ($) |
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 | $ 71,800 | $ 74,200 | ||||
Net losses | 20,580 | $ 12,146 | $ 77,056 | ||||
Accumulated deficit | 152,373 | 131,793 | |||||
Cash and cash equivalents | 64,603 | 44,551 | |||||
Short-term investments | 4,997 | $ 40,000 | |||||
Cash resources available under the secured credit facility | $ 15,000 | ||||||
Scenario, Forecast | |||||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||||||
Cash resources available under the secured credit facility | $ 15,000 | ||||||
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 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares Outstanding (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from computation of diluted weighted-average shares outstanding | 1,258,302 | 7,807,964 |
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 | 1,091,238 | 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 | 7,396,313 | |
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 | 60,250 | 163,523 |
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 | 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 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019USD ($)Segment | Jan. 01, 2019USD ($) | |
Accounting Policies [Line Items] | ||
Number of business segments | Segment | 1 | |
Right-of-use asset | $ 7,504 | |
Lease liability | $ 7,559 | |
ASU 2016-02 | ||
Accounting Policies [Line Items] | ||
Right-of-use asset | $ 7,600 | |
Lease liability | $ 7,800 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Distribution of Total Operating Expenses by Geographical Area (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Segment Reporting Information [Line Items] | ||
Operating expenses | $ 20,503 | $ 12,394 |
Ireland | ||
Segment Reporting Information [Line Items] | ||
Operating expenses | 17,436 | 9,964 |
U.S. | ||
Segment Reporting Information [Line Items] | ||
Operating expenses | $ 3,067 | $ 2,430 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Distribution of Long-Lived Assets by Geographical Area (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Segment Reporting Information [Line Items] | ||
Long lived assets | $ 12,226 | $ 4,810 |
Ireland | ||
Segment Reporting Information [Line Items] | ||
Long lived assets | 9,970 | 4,565 |
U.S. | ||
Segment Reporting Information [Line Items] | ||
Long lived assets | $ 2,256 | $ 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 | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 4,997 | $ 40,000 |
Other asset – advance payment to supplier | 2,617 | 2,649 |
Total | 7,614 | 42,649 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 4,997 | 40,000 |
Total | 4,997 | 40,000 |
Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Other asset – advance payment to supplier | 2,617 | 2,649 |
Total | $ 2,617 | $ 2,649 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 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 Condensed Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Book Value | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Current portion of long-term debt | $ 2,056 | $ 1,019 |
Long-term debt, less current portion | 12,139 | 13,079 |
Total | 14,195 | 14,098 |
Approximate Fair Value | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Current portion of long-term debt | 2,056 | 1,019 |
Long-term debt, less current portion | 11,850 | 13,035 |
Total | 13,906 | 14,054 |
Level 2 | Approximate Fair Value | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Current portion of long-term debt | 2,056 | 1,019 |
Long-term debt, less current portion | 11,850 | 13,035 |
Total | $ 13,906 | $ 14,054 |
Short Term Investments - Additi
Short Term Investments - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2019 | |
Available For Sale Securities [Abstract] | |
Short term investments maturity period | 1 month 13 days |
Short Term Investments - Schedu
Short Term Investments - Schedule of Available for Sale Short-term Investments by Major Security Types (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
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 | $ 4,986 | 35,745 |
Available for sale, Unrealized gains | 11 | 272 |
Available for sale, Unrealized (losses) | (9) | |
Available for sale, Fair Value Total | 4,997 | 36,008 |
Available for sale, Maturity by period Less than 1 year | $ 4,997 | 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 | Mar. 31, 2019 | Dec. 31, 2018 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Prepaid research and development expenses | $ 5,315 | $ 5,351 |
Short-term deposits | 873 | 959 |
Research and development tax credit receivable | 395 | 404 |
Prepaid insurance | 245 | 438 |
Interest receivable | 151 | 158 |
Other prepaid assets | 141 | 921 |
Value added tax receivable | 68 | 159 |
Total | $ 7,188 | $ 8,390 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment and Related Accumulated Depreciation (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 911 | $ 901 |
Less: accumulated depreciation | (236) | (201) |
Property and equipment, net | 675 | 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 | $ 118 | $ 108 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |||
Depreciation expense | $ 35 | $ 31 | $ 136 |
Leases - Additional Information
Leases - Additional Information (Details) - Office Space and Commercial Property $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Operating Leased Assets [Line Items] | |
Lessee, operating lease, description | These leases have terms which range from six 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 | $ 254 |
Minimum | |
Operating Leased Assets [Line Items] | |
Lessee, operating lease, term of contract | 6 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 | 3 Months Ended | |
Mar. 31, 2019USD ($) | ||
Leases [Abstract] | ||
Cash paid for operating lease liabilities | $ 190 | |
Right-of-use assets obtained in exchange for new operating lease obligation | $ 7,622 | [1] |
Weighted-average remaining lease term | 13 years 2 months 12 days | |
Weighted-average discount rate | 7.60% | |
[1] | All operating leases included above were held at January 1, 2019 |
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 | Mar. 31, 2019USD ($) |
Schedule Of Lease Assets And Liabilities [Abstract] | |
Right-of-use asset | $ 7,504 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsMember |
Other current liabilities | $ 442 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherCurrentLiabilitiesMember |
Other liabilities | $ 7,117 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesMember |
Total lease liabilities | $ 7,559 |
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 | Mar. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 982 |
2021 | 1,017 |
2022 | 1,022 |
2023 | 1,033 |
2024 | 1,038 |
Thereafter | 6,420 |
Total | 11,512 |
Less imputed interest | (3,953) |
Lease liability | $ 7,559 |
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 | Mar. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued clinical trial costs | $ 6,383 | $ 2,849 |
Accrued manufacturing expenses | 859 | 1,439 |
Accrued other expenses | 843 | 954 |
Accrued payroll and bonus expenses | 611 | 1,804 |
Total | $ 8,696 | $ 7,046 |
Shareholders' Equity - Reconcil
Shareholders' Equity - Reconciliation of Beginning and Ending Balances in Shareholders' Equity (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Class Of Stock [Line Items] | |||
Shareholders' equity, Beginning Balance | $ 71,622 | $ 39,494 | $ 39,494 |
Exercise of share options | 48 | ||
Share-based compensation expense | 540 | 149 | |
Net loss | (20,580) | (12,146) | (77,056) |
Shareholders' equity, Ending Balance | $ 51,630 | 59,656 | $ 71,622 |
Series B Convertible Preferred Shares | |||
Class Of Stock [Line Items] | |||
Issuance of Series B convertible preferred shares, net | $ 32,159 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 05, 2018 | Oct. 14, 2016 | Oct. 14, 2015 | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Mar. 14, 2018 | May 18, 2017 | Nov. 18, 2015 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Ordinary shares, shares issued | 14,367,441 | 14,352,046 | |||||||
Share options granted | 442,500 | ||||||||
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 | ||||||
Expense recognized | $ 85 | $ 82 | |||||||
Unamortized stock compensation expense | $ 175 | $ 510 | |||||||
Stock-based compensation expense, expected weighted average period for recognition | 6 months 14 days | 1 year 6 months 14 days | |||||||
Number of shares, outstanding | 60,250 | 86,068 | |||||||
Restricted Ordinary Shares | Tranche One | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Percentage of awards vested | 25.00% | ||||||||
Employee Share Options | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Expense recognized | $ 307 | $ 67 | |||||||
Unvested employee options outstanding | 984,913 | 221,553 | |||||||
Unamortized compensation expense share options | $ 4,168 | $ 1,132 | |||||||
Vesting period | 3 years 3 months 18 days | 3 years 3 months 7 days | |||||||
Employees and Directors | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Share options granted | 442,500 | ||||||||
Restricted Share Units (RSUs) | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Grant date fair value | $ 13 | $ 13 | |||||||
Expense recognized | $ 119 | ||||||||
Unamortized stock compensation expense | $ 72 | ||||||||
Stock-based compensation expense, expected weighted average period for recognition | 1 month 24 days | ||||||||
Number of shares, awarded | 0 | 0 | |||||||
Number of shares, outstanding | 36,924 | 36,924 | 0 | ||||||
Restricted Share Units (RSUs) | Director | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Vesting period | 1 year | ||||||||
Performance RSUs | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Grant date fair value | $ 8.21 | ||||||||
Expense recognized | $ 29 | ||||||||
Unamortized stock compensation expense | $ 381 | ||||||||
Stock-based compensation expense, expected weighted average period for recognition | 1 year 6 months 21 days | ||||||||
Number of shares, awarded | 50,000 | 0 | |||||||
Number of shares, outstanding | 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 11 months 23 days | 2 years 3 months 25 days | |||||||
Unamortized compensation expense | $ 4,796 | $ 1,642 | |||||||
Two Thousand Fifteen Equity Incentive 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 | ||||||||
2018 Plan | Employee Share Options | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Share options granted | 74,152 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Restricted Ordinary Shares Activity (Details) - Restricted Ordinary Shares | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Number of Shares | |
Number of Shares, Unvested, Beginning balance | shares | 86,068 |
Number of Shares, Vested | shares | (25,818) |
Number of Shares, Unvested, Ending balance | shares | 60,250 |
Weighted Average grant date fair value per share | |
Weighted Average grant date fair value per share, Unvested, Beginning balance | $ / shares | $ 3.14 |
Weighted Average grant date fair value per share, Vested | $ / shares | 3.14 |
Weighted Average grant date fair value per share, Unvested, Ending balance | $ / shares | $ 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 | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Volatility | 60.00% | |
Volatility, minimum | 69.50% | |
Volatility, maximum | 70.20% | |
Expected term in years | 6 years 3 months | 6 years 3 months |
Dividend rate | 0.00% | 0.00% |
Risk-free interest rate | 1.63% | |
Risk-free interest rate, minimum | 2.44% | |
Risk-free interest rate, maximum | 2.57% | |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share price | $ 5.80 | |
Fair value of option on grant date | 3.74 | |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share price | 6.80 | |
Fair value of option on grant date | $ 4.41 |
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 | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Compensation Related Costs [Abstract] | ||
Number of Shares, Options outstanding Beginning Balance | 665,219 | |
Number of Shares, Granted | 442,500 | |
Number of Shares, Exercised | (15,395) | |
Number of Shares, Forfeited | (1,086) | |
Number of Shares, Options outstanding Ending Balance | 1,091,238 | 665,219 |
Number of Shares, Exercisable at March 31, 2019 (unaudited) | 106,325 | |
Weighted Average Exercise Price, Options outstanding Beginning Balance | $ 9.31 | |
Weighted Average Exercise Price, Granted | 5.82 | |
Weighted Average Exercise Price, Exercised | 3.16 | |
Weighted Average Exercise Price, Forfeited | 9.44 | |
Weighted Average Exercise Price, Options outstanding Ending Balance | 7.98 | $ 9.31 |
Weighted Average Exercise Price, Exercisable at March 31, 2019 (unaudited) | $ 4.59 | |
Weighted Average Remaining Contractual Life in Years, Options outstanding | 9 years 3 months 7 days | 8 years 11 months 4 days |
Weighted Average Remaining Contractual Life in Years, Exercisable at March 31, 2019 (unaudited) | 8 years 3 months | |
Aggregate Intrinsic Value, Options outstanding | $ 395 | |
Aggregate Intrinsic Value, Options outstanding | 1,956 | $ 395 |
Aggregate Intrinsic Value, Exercisable at March 31, 2019 (unaudited) | $ 425 |
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 | 3 Months Ended | |
Mar. 31, 2019 | Mar. 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 | 0 | 0 |
Number of Shares, Unvested, Ending balance | 36,924 | 0 |
Weighted Average grant date fair value per share, Unvested, Beginning balance | $ 13 | |
Weighted Average grant date fair value per share, Unvested, Ending balance | $ 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 | 3 Months Ended | |
Mar. 31, 2019 | Mar. 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 | 0 |
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 | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Research and Development Expense | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 163 | $ 71 |
General and Administrative Expense | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 377 | $ 78 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Income Tax [Line Items] | |||
Income tax expense | $ 134 | $ 89 | |
Ireland | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards | $ 16,183 | $ 13,648 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Jun. 30, 2016 | Nov. 18, 2015 |
Other Commitments [Line Items] | |||||
Purchase obligation | $ 1,571,000 | $ 1,604,000 | $ 2,805,000 | ||
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 | $ 2,300,000 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | Apr. 27, 2018 | Mar. 31, 2019 |
Debt Instrument [Line Items] | ||
Maximum amount available under second draw | $ 15,000,000 | |
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 | |
Maximum amount available under agreement | $ 30,000,000 | |
Remaining borrowing facility available date | Oct. 31, 2019 | |
Non-utilization fee percentage of undrawn principal amount | 1.50% | |
Minimum fixed interest rate per annum | 8.31% | |
Frequency of amortization payments | Monthly | |
Date of first required payment of initial draw | Nov. 1, 2019 | |
Extended date of first required payment if second draw made | Apr. 1, 2020 | |
Final interest rate payment on outstanding principal | 4.20% | |
Principal and interest payment, maturity date | Mar. 1, 2022 | |
Final payment fee | $ 600,000 | |
Prepayment fee in first year | 3.00% | |
Prepayment fee in second year | 2.00% | |
Prepayment fee thereafter | 1.00% | |
Effective annual interest rate on outstanding debt | 11.40% | |
Interest expense | $ 448,000 | |
Accretion of debt discounts and deferred financing costs | $ 98,000 | |
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 | Mar. 31, 2019USD ($) |
Debt Disclosure [Abstract] | |
2019 (remaining) | $ 1,034 |
2020 | 6,207 |
2021 | 6,207 |
2022 | 1,552 |
Long-term Debt | $ 15,000 |