Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Jul. 31, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | MGTX | |
Entity Registrant Name | MeiraGTx Holdings plc | |
Entity Central Index Key | 1,735,438 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 27,184,132 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 102,060,551 | $ 8,548,638 |
Prepaid expenses | 1,613,955 | 1,961,243 |
Other current assets | 311,283 | 965,233 |
Total Current Assets | 103,985,789 | 11,475,114 |
Property and equipment, net | 13,567,806 | 14,255,729 |
Restricted cash | 123,376 | 123,376 |
TOTAL ASSETS | 117,676,971 | 25,854,219 |
CURRENT LIABILITIES: | ||
Accounts payable | 3,461,441 | 7,055,380 |
Accrued expenses | 5,289,261 | 9,332,944 |
Note payable | 1,442,009 | |
Warrant liability | 2,679,633 | |
Capitalized lease obligation-current portion | 28,715 | 30,850 |
Due to Kadmon | 0 | 861,030 |
Total Current Liabilities | 8,779,417 | 21,401,846 |
Capitalized lease obligation | 20,732 | 34,298 |
Deferred rent | 224,367 | 266,290 |
Other liabilities | 180,350 | 178,419 |
TOTAL LIABILITIES | 9,204,866 | 21,880,853 |
COMMITMENTS | ||
Convertible Preferred C Shares 0 and 5,005,935 outstanding at June 30, 2018 December 31, 2017, respectively (liquidation preference of $52,455,700 at December 31, 2017) | 51,338,631 | |
SHAREHOLDERS' EQUITY (DEFICIT): | ||
A Ordinary Shares, $0.00003881 nominal value 27,184,132 issued and outstanding at June 30, 2018 8,826,190 issued and 8,714,563 issued and outstanding at December 31, 2017 | 1,055 | 342 |
Capital in excess of nominal value | 221,080,313 | 20,080,713 |
Accumulated other comprehensive loss | (801,235) | (2,022,477) |
Accumulated deficit | (111,808,028) | (65,423,843) |
Total Shareholders' Equity (Deficit) | 108,472,105 | (47,365,265) |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS' EQUITY (DEFICIT) | $ 117,676,971 | $ 25,854,219 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Preferred Stock, Shares Outstanding | 0 | 5,005,935 |
Preferred Stock, Liquidation Preference, Value | $ 52,455,700 | |
Common stock, par value | $ 0.00003881 | $ 0.00003881 |
Common stock, shares issued | 27,184,132 | 8,826,190 |
Common stock, shares outstanding | 27,184,132 | 8,714,563 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Operating expenses: | ||||
General and administrative | $ 17,378,052 | $ 2,221,896 | $ 28,500,068 | $ 4,370,436 |
Research and development | 7,790,694 | 5,363,545 | 14,718,016 | 10,186,902 |
Total operating expenses | 25,168,746 | 7,585,441 | 43,218,084 | 14,557,338 |
Loss from operations | (25,168,746) | (7,585,441) | (43,218,084) | (14,557,338) |
Other non-operating income (expense): | ||||
Other income | 83,075 | 83,075 | ||
Foreign currency (loss) gain | (2,726,624) | 449,625 | (1,748,000) | 598,874 |
Change in fair value of warrant liability | (2,184,183) | (1,514,775) | ||
Interest income | 25,354 | 7,991 | 50,662 | 18,380 |
Interest expense | (9,708) | (50,894) | (37,063) | (59,020) |
Net loss | (29,980,832) | (7,178,719) | (46,384,185) | (13,999,104) |
Other comprehensive income (loss) | 1,979,007 | (345,019) | 1,221,242 | (475,914) |
Comprehensive loss | (28,001,825) | (7,523,738) | (45,162,943) | (14,475,018) |
Net loss | (29,980,832) | (7,178,719) | (46,384,185) | (13,999,104) |
Accretion on convertible preferred C shares and warrants | (1,141,794) | (30,401) | (1,806,512) | (53,162) |
Adjusted net loss | $ (31,122,626) | $ (7,209,120) | $ (48,190,697) | $ (14,052,266) |
Basic and diluted net loss per ordinary share | $ (2.29) | $ (0.85) | $ (4.27) | $ (1.64) |
Weighted-average number of ordinary shares outstanding | 13,611,452 | 8,505,149 | 11,280,804 | 8,545,437 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS' EQUITY (DEFICIT) - 6 months ended Jun. 30, 2018 - USD ($) | Total | IPO [Member] | Convertible Preferred C Shares [Member] | Convertible Preferred C Shares [Member]Accounts Payable [Member] | Convertible Preferred C Shares [Member]License Agreement [Member] | Convertible Preferred C Shares [Member]Sales Agreement [Member] | A Ordinary Shares [Member] | A Ordinary Shares [Member]IPO [Member] | Capital in Excess of Nominal Value [Member] | Capital in Excess of Nominal Value [Member]IPO [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2017 | $ (47,365,265) | $ 342 | $ 20,080,713 | $ (2,022,477) | $ (65,423,843) | |||||||
Temporary equity, beginning Balance at Dec. 31, 2017 | $ 51,338,631 | |||||||||||
Sale of A ordinary shares in initial public offering, net of issuance costs | $ 65,458,470 | $ 194 | $ 65,458,276 | |||||||||
Beginning Balance, Shares at Dec. 31, 2017 | 8,826,190 | |||||||||||
Temporary equity, beginning Balance, Shares at Dec. 31, 2017 | 5,005,935 | 5,005,935 | ||||||||||
Accretion of issuance costs on convertible preferred C shares | $ (761,012) | (761,012) | ||||||||||
Issuance of convertible preferred C shares, net of issuance costs | $ 1,356,129 | $ 140,000 | $ 56,159,119 | |||||||||
Accretion of warrants issued in connection with convertible preferred C shares | (1,045,500) | (1,045,500) | ||||||||||
Issuance of shares, net of issuance costs, Shares | 129,419 | 13,360 | 5,425,124 | 5,000,000 | ||||||||
Accretion of issuance costs on convertible preferred C shares | $ 761,012 | |||||||||||
Accretion of warrants issued in connection with convertible preferred C shares | 1,045,500 | |||||||||||
Exercise of warrants | 4,194,408 | $ 9,720,000 | 4,194,408 | |||||||||
Exercise of warrants, Share | 927,594 | |||||||||||
Conversion convertible preferred C shares into A ordinary shares | 120,520,391 | $ (120,520,391) | $ 446 | 120,519,945 | ||||||||
Conversion of convertible preferred C shares into A ordinary shares, Shares | (11,501,432) | 11,501,432 | ||||||||||
Share-based compensation | $ 12,633,556 | $ 73 | 12,633,483 | |||||||||
Share-based compensation, Shares | 1,856,510 | |||||||||||
Temporary equity, ending Balance, Shares at Jun. 30, 2018 | 0 | |||||||||||
Foreign currency translation | $ 1,221,242 | 1,221,242 | ||||||||||
Net loss | (46,384,185) | (46,384,185) | ||||||||||
Ending Balance at Jun. 30, 2018 | $ 108,472,105 | $ 1,055 | $ 221,080,313 | $ (801,235) | $ (111,808,028) | |||||||
Ending Balance, Shares at Jun. 30, 2018 | 27,184,132 |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS' EQUITY (DEFICIT) (Parenthetical) | 6 Months Ended |
Jun. 30, 2018USD ($) | |
IPO [Member] | |
Sale of A ordinary shares in initial public offering, issuance costs | $ 9,541,530 |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Cash flows from operating activities: | |||||
Net loss | $ (29,980,832) | $ (7,178,719) | $ (46,384,185) | $ (13,999,104) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Preferred C shares issued in connection with a license agreement | 137,973 | ||||
Share-based compensation expense | 12,633,556 | 1,535,090 | |||
Foreign currency loss (gain) | 2,726,624 | (449,625) | 1,748,000 | (598,874) | |
Depreciation | 1,015,079 | 373,276 | |||
Amortization of interest on asset retirement obligation | 7,322 | 9,255 | $ 19,313 | ||
Change in fair value of warrant liability | 2,184,183 | 1,514,775 | |||
Decrease (increase) in operating assets: | |||||
Prepaid expenses and other current assets | 317,130 | 6,134 | |||
Other current assets | 650,528 | (739,977) | |||
Increase (decrease) in operating liabilities: | |||||
Deferred rent | (42,095) | 784,493 | |||
Due to Kadmon | (861,030) | 30,065 | |||
Accounts payable | (2,413,642) | 1,646,167 | |||
Accrued expenses | (4,748,762) | 352,544 | |||
Other liabilities | 70,200 | ||||
Net cash used in operating activities | (36,425,351) | (10,530,731) | |||
Cash flows from investing activities: | |||||
Issuance of long-term note payable | 2,500,000 | ||||
Purchase of property and equipment | (1,318,016) | (4,824,514) | |||
Net cash used in investing activities | (1,318,016) | (2,324,514) | |||
Cash flows from financing activities: | |||||
Payments on capitalized lease obligation | (15,701) | (9,257) | |||
Exercise of warrants | 9,720,000 | ||||
Proceeds from the sale of ordinary shares | 69,750,000 | ||||
Proceeds from the sale of convertible preferred C shares | 56,849,592 | 210,244 | |||
Payment of note payable | (1,442,009) | ||||
Net cash provided by financing activities | 131,469,856 | 194,863 | |||
Net increase (decrease) in cash, cash equivalents and restricted cash | 93,726,489 | (12,660,382) | |||
Effect of exchange rate changes on cash | (214,576) | 69,691 | |||
Cash, cash equivalents and restricted cash at beginning of period | 8,672,014 | 17,921,485 | 17,921,485 | ||
Cash, cash equivalents and restricted cash at end of period | $ 102,183,927 | $ 5,330,794 | 102,183,927 | 5,330,794 | $ 8,672,014 |
Supplemental disclosure of non-cash transactions: | |||||
Fixed asset acquisition included in accounts payable and accrued expenses at end of period | 298,551 | 1,561,299 | |||
Issuance of convertible preferred C shares in connection with payables | 1,356,129 | ||||
Conversion of convertible preferred C shares into ordinary shares | 120,520,391 | ||||
Reclassification of warrant liability upon exercise of warrants | 4,194,408 | ||||
Capitalized lease obligation for equipment purchase | 78,063 | ||||
Supplemental disclosure of cash flow information: | |||||
Cash paid for interest | 31,531 | 1,337 | |||
A Ordinary Shares [Member] | |||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Share-based compensation expense | 6,456,215 | ||||
Cash flows from financing activities: | |||||
Issuance costs in connection with shares | (2,781,553) | ||||
Supplemental disclosure of non-cash transactions: | |||||
Issuance costs in connection with sale of convertible preferred C shares included in accrued expenses at end of period | 1,509,977 | ||||
Convertible Preferred C Shares [Member] | |||||
Cash flows from financing activities: | |||||
Issuance costs in connection with shares | (610,473) | $ (6,124) | |||
Supplemental disclosure of non-cash transactions: | |||||
Issuance costs in connection with sale of convertible preferred C shares included in accrued expenses at end of period | $ 80,000 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation: The Company MeiraGTx Holdings plc, a limited company under the laws of the Cayman Islands, is a clinical-stage biotech company developing novel gene therapy treatments for a wide range of inherited and acquired disorders for which there are no effective treatments available. The Company is focused on developing therapies for ocular diseases, including rare inherited blindness as well as Xerostomia following radiation treatment for head and neck cancers and neurodegenerative diseases such as amyothrophic lateral sclerosis (“ALS”). Reorganization and Initial Public Offering On May 28, 2018, the Board of Directors of MeiraGTx Limited approved the Reorganization Transactions, effective June 7, 2018, pursuant to which the Board of Directors approved the transfer of the shares held by each of the MeiraGTx Limited’s shareholders for the equivalent class and number of shares issued by Meira Holdings. On June 7, 2018, the Company completed its IPO, selling 5,000,000 Series A ordinary shares (“Ordinary Shares”) at a public offering price of $15.00 per share, and receiving $65.9 million in net proceeds, after deducting underwriting discounts and commissions and offering expenses payable by us. Reverse Share Split On June 7, 2018 MeiraGTx Limited’s Board of Directors and shareholders approved a 1:3.881 reverse share split. All share information presented in these financial statements and accompanying footnotes have been retroactively adjusted to reflect the decreased number of shares resulting from this action. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Interim Financial Statements The accompanying condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q S-X. six-month S-1 No. 333-224914), Liquidity The Company has not generated any revenues and has not yet achieved profitable operations. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of the Company’s product candidates will require significant additional financing. Management expects to incur substantial and increasing losses in future periods. The success of the Company is subject to certain risks and uncertainties, including among others, uncertainty of product development; competition in the Company’s field of use; uncertainty of capital availability; uncertainty in the Company’s ability to enter into agreements with collaborative partners; dependence on third parties; and dependence on key personnel. The Company has not generated positive cash flows from operations, and there are no assurances that the Company will be successful in obtaining an adequate level of financing for the development and commercialization of its product candidates. As of June 30, 2018, the Company had cash and cash equivalents in the amount of $102,060,551, which consisted of depository accounts. The Company estimates that its cash and cash equivalents on hand at June 30, 2018 will cover its expenses into the second quarter of 2020. Risks and Uncertainties The Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risks, including the potential risk of business failure. The Company’s limited capital resources and operations to date have been funded primarily with the proceeds from private equity offerings and the IPO. In the future, the Company may seek to raise additional capital through equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources to enable it to complete the development and potential commercialization of its product candidates. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 2. Summary of Significant Accounting Policies and Recent Accounting Pronouncements: Certain of the Company’s significant accounting policies are described below. All of the Company’s significant accounting policies are disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2017 included in the Company’s Prospectus. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. Consolidation The accompanying condensed consolidated financial statements include the accounts of Meira Holdings and its wholly owned subsidiaries: MeiraGTx Limited, a limited company under the laws of England and Wales (“Meira Limited); MeiraGTx, LLC, a Delaware corporation (“Meira LLC”); BRI-Alzan, Inc., a Delaware corporation (“BRI-Alzan”); MeiraGTx B.V., a Netherlands corporation (“Meira BV”); MeiraGTx UK II Limited, (“Meira UK II”), a limited company under the laws of England and Wales; MeiraGTx UK Limited (“Meira UK”), a limited company under the laws of England and Wales. All intercompany balances and transactions between the consolidated companies have been eliminated in consolidation. Use of Estimates Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the consolidated financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these consolidated financial statements, management used significant estimates in the following areas, among others: valuation of A ordinary shares (“Ordinary Shares”) issued prior to the Company’s initial public offering, for the acquisition of assets, the accounting for research and development costs, warrants, share based compensation, asset retirement obligations and accrued expenses. Fair Value Measurements Fair value is defined as the price that would be received upon sale of an asset or paid upon transfer of a liability in an orderly transaction between market participants at the measurement date and in the principal or most advantageous market for that asset or liability. The fair value should be calculated based on assumptions that market participants would use in pricing the asset or liability, not on assumptions specific to the entity. In addition, the fair value of liabilities should include consideration of non-performance The Company follows ASC Topic 820, Fair Value Measurements and Disclosures • Level 1: Observable inputs such as quoted prices in active markets for identical assets the reporting entity has the ability to access as of the measurement date; • Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and • Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. The table below represents the values of the Compnay’s financial assets and liabilities that are required to be measured at fair value on a recurring basis: Fair Value Measurement Using: Description June 30, Significant Significant Other Significant Restricted cash $ 123,376 $ 123,376 $ — $ — Fair Value Measurement Using: Description December 31, Significant Significant Other Significant Restricted cash $ 123,376 $ 123,376 $ — $ — Warrants $ 2,679,633 $ — $ — $ 2,679,633 The table below represents a rollforward of the assets and liabilities that are required to be measured at fair value on a recurring basis from December 31, 2017 to June 30, 2018: Significant Balance as of December 31, 2017 $ 2,679,633 Change in fair value of warrants 1,514,775 Exercise of warrants (4,194,408 ) Balance as of June 30, 2018 $ — The warrants were classified as liabilities because the underlying Preferred Shares had a redemption feature in the event of a change of control of the Company. On June 5, 2018, the warrants were exercised at which time the warrant liability was determined to be $4,194,408, which represented the difference in the market value of the Preferred Shares and the exercise price of the warrants. This resulted in an increase of the warrant liability in the amount of $2,184,183 and $1,514,775 for the three-month and six-month The fair values of the warrants at December 31, 2017, March 31, 2018 and June 4, 2018 were estimated using the Black-Scholes valuation model with the following assumptions: December 31, 2017 March 31, 2018 June 4, 2018 Risk-free interest rate 1.72 % 1.86 % 1.77 % Expected volatility 80 % 80 % 80 % Expected dividend yield 0 0 0 Expected life 9 months 5.5 months 1 day For the unobservable inputs for the warrants, the expected volatility was determined at each measurement date by taking an average of the volatility of other publicly-traded peer biotechnology companies. The expected life was determined at each measurement date based upon the Company’s estimate of the time until the Company has a conversion event. The fair value of the Preferred Shares was based upon recent issuances of the Company’s Preferred Shares on or about December 31, 2017, March 31, 2018 and June 5, 2018. The estimated fair values of the Company’s warrants are not necessarily indicative of the amounts that would be realized in a current market exchange. The determination of the fair value of the warrants are sensitive to changes in in the assumptions used and a change in those inputs could result in a significantly higher or lower fair value measurement. If the volatility were to increase or the expected life were to increase, the fair value of the warrant would increase. Conversely, if the volatility were to decrease or the expected life were to decrease, the fair value of the warrant would decrease. Net Loss per Ordinary Share Basic net loss per Ordinary Share is computed by dividing net loss attributable to the Company’s shareholders by the weighted average number of shares of the Company’s Ordinary Shares assumed to be outstanding during the period of computation. Diluted net loss per ordinary share is computed similar to basic net loss per share except that the denominator is increased to include the number of additional Ordinary Shares that would have been outstanding if the potential ordinary shares had been issued at the beginning of the year and if the additional ordinary shares were dilutive (treasury stock method) or the two-class Asset Retirement Obligation Accounting for Asset Retirement Obligations requires legal obligations associated with the retirement of long-lived assets to be recognized at fair value when incurred and capitalized as part of the related long-lived asset. In the absence of quoted market prices, we estimate the fair value of our asset retirement obligations using Level 3 present value techniques, in which estimates of future cash flows associated with retirement activities are discounted using a credit-adjusted risk-free rate. Asset retirement obligations currently reported as other liabilities on our Consolidated Balance Sheet were measured during a period of historically low interest rates. The impact on measurements of new asset retirement obligations using different rates in the future may be significant. The Company uses estimates to determine the amount of the asset retirement obligations at the end of the lease term and discounts such asset retirement obligations using an estimated discount rate. Interest on the discounted asset retirement obligation is amortized over the term of the lease using the effective interest method and is recorded as interest expense in the consolidated statements of operations and comprehensive loss. The change in asset retirement obligations is as follows: For the six month period For the year ended Balance at beginning of period $ 178,419 $ 221,254 Amortization of interest 7,322 19,313 Change in estimate — (75,011 ) Effects of exchange rate (5,391 ) 12,863 Balance at end of period $ 180,350 $ 178,419 Research and Development Research and development costs are charged to expense as incurred. These costs include, but are not limited to, employee-related expenses, including salaries, benefits and travel of the Company’s research and development personnel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical and preclinical studies and manufacture the drug product for the clinical studies and preclinical activities; acquisition of in-process Costs for certain development activities, such as Company funded outside research programs, are recognized based on an evaluation of the progress to completion of specific tasks with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. Segment Information Management has concluded it has a single reporting segment for purposes of reporting financial condition and results of operations. The following table summarizes non-current June 30, 2018 December 31, 2017 United States $ 413,481 $ 436,463 United Kingdom 13,277,701 13,942,642 $ 13,691,182 $ 14,379,105 Recent Accounting Pronouncements In June 2018, the FASB issued ASU 2018-07, 505-50 all 2018-07 In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business, ASU 2017-01 , ASU 2017-01 ASU 2017-01 also ASU 2017-01 should 2017-01 In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, or ASU 2016-20, that allows met. ASU 2016-20 also requires ASU 2014-09. ASU 2014-09. ASU 2016-20 In November 2016, the Financial Accounting Standards Board, or FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash ASU 2016-18, which the beginning-of-period and end-of-period amounts ASU 2016-18 also ASU 2016-18 will ASU 2016-18 In October 2016, the FASB issued ASU 2016-16, Income Intra-Entity Transfers of Assets Other than Inventory ASU 2016-16 which ASU 2016-16 to In May 2016, the FASB issued ASU No. 2016-12 , Revenue from Contracts with Customers (Topic 606), Narrow-Scope Improvements and Practical Expedients ASU 2016-12, which ASU No. 2014-09 Revenue from Contracts with Customers (Topic 606) ASU 2014-09, on ASU 2016-12 are ASU 2014-09, as ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date ASU 2015-14 . ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606), Identifying Performance Obligations and Licensing ASU 2016-10 , ASU 2016-10 requires 2016-10 categorizes ASU 2016-10 has ASU 2014-09, as ASU 2015-14. In ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606), Principal versus Agent Considerations (Reporting Revenue Gross versus Net) ASU 2016-08, which ASU 2014-09 ASU 2016-08 has ASU 2014-09, as ASU 2015-14. The In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers 2014-09, 2014-09 2014-09 2014-09 non-public 2014-09 2014-09 2014-09 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 3. Accrued Expenses Accrued expenses for the period presented were comprised of the following: June 30, 2018 December 31, 2017 Clinical Trial Costs $ 2,297,893 $ 4,859,410 Compensation and Benefits 645,286 2,386,903 Consulting 1,137,547 1,220,477 Rent 128,683 387,267 Professional Fees 733,409 231,923 Interest 30,600 33,437 Travel 135,664 — Other 180,179 213,527 $ 5,289,261 $ 9,332,944 |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 4. Share-Based Compensation 2018 and 2016 Equity Incentive Plans The Company maintains the 2018 Incentive Award Plan and 2016 Equity Incentive Plan (together, the “Plans”), under which, the Company has granted share options to selected officers, employees and non-employee A summary of the Company’s share option activity related to employees, non-employee non-employee six-month Number of Options Weighted- Aggregate Outstanding at December 31, 2017 938,637 $ 5.12 $ 1,420,650 Granted 675,685 5.63 Exercised — — Expired — — Forfeited — — Outstanding at June 30, 2018 1,614,322 $ 5.34 $ 9,884,932 Weighted average remaining contractual life of options outstanding as of December 31, 2017 (yrs) 9.09 Weighted average remaining contractual life of options outstanding as of June 30, 2018 (yrs) 8.97 Options exercisable at December 31, 2017 186,395 $ 7.72 $ — Options exercisable at June 30, 2018 265,221 $ 7.69 $ 999,410 Weighted average remaining contractual life of options exercisable as of December 31, 2017 (yrs) 8.21 Weighted average remaining contractual life of options exercisable as of June 30, 2018 (yrs) 7.86 The total fair value of options vested during the three-month periods ended June 30, 2018 and 2017 was $247,202 and $229,250, respectively. The total fair value of options vested during the six-month During the six-month non-employee 2018 Risk-free interest rate 2.32% - 2.40% Expected volatility 90% Expected dividend yield 0% Expected life of employee and Board of Directors’ options (in years) 5.5 - 6.1 As of June 30, 2018, the total compensation expense relating to unvested options granted to employees and non-employee During the six-month non-employee 505-50, non-employee 2018 2017 Risk-free interest rate 2.80% - 2.84% 2.29% - 2.31% Expected volatility 90% 80% Expected dividend yield 0% 0% Expected life of non-employee 7.7 - 9.5 8.7 - 9.7 As of June 30, 2018, the total compensation expense relating to unvested options granted to non-employee The weighted average grant date fair value of options granted to employees, non-employee non-employee six-month Restricted Ordinary Shares In 2015, in connection with certain service and consulting agreements, certain employees and a consultant were awarded an aggregate of 867,935 restricted Ordinary Shares of the Company. Such shares were subject to forfeiture over a three-year service period. The shares granted to the consultant and employees were valued at $7.72 and $7.76 per share, respectively, and were included in loss from operations over the requisite service period. As of June 30, 2018, all such shares are no longer subject to forfeiture as the three-year service period has been completed. On June 7, 2018, 1,306,348 restricted Ordinary Shares, which represented 5% of the fully-diluted outstanding shares of the Company as of such date, were issued to certain members of senior management in accordance with their employment agreements. One-third S-1 A summary of the restricted Ordinary Shares is as follows: Ordinary Shares $ Value Non-vested 105,913 $ 865,861 Issued during the six-month 1,306,348 19,595,220 Vesting during the six-month (541,363 ) (7,397,611 ) Non-vested 870,898 $ 13,063,470 Ordinary Shares On March 1, 2018, a funding milestone was met under the employment agreements for certain members of senior management. Accordingly, the employees were issued an aggregate of 550,162 fully vested Ordinary Shares, which represented 3% of the fully-diluted outstanding shares of the Company as of such date. The shares were recorded as share-based compensation in the amount of $3,096,104. Additionally, under the terms of the employment agreements, the Company was required to pay the income taxes incurred by the grantees in connection with the grant of those shares. Total compensation expense in connection with the issuance of those Ordinary Shares, in the amount of $6,456,215, of which $3,096,012 was share-based, was recorded as general and administrative expense during the six-month During the three-month and six-month Three-month periods ended June 30, 2018 2017 Research and development $ 1,045,561 $ 550,708 General and administrative 7,318,224 131,427 Total share based compensation $ 8,363,785 $ 682,135 Six-month periods ended June 30, 2018 2017 Research and development $ 1,890,511 $ 1,239,923 General and administrative 10,743,045 295,167 Total share based compensation $ 12,633,556 $ 1,535,090 The Company does not expect to realize any tax benefits from its share option activity or the recognition of share-based compensation expense because the Company currently has net operating losses and has a full valuation allowance against its deferred tax assets. Accordingly, no amounts related to excess tax benefits have been reported in cash flows from operations or cash flows from financing activities for the three-month and six-month |
Ordinary Shares and Convertible
Ordinary Shares and Convertible Preferred C Shares | 6 Months Ended |
Jun. 30, 2018 | |
Federal Home Loan Banks [Abstract] | |
Ordinary Shares and Convertible Preferred C Shares | 5. Ordinary Shares and Convertible Preferred C Shares: Ordinary Shares As discussed in Note 3, on March 1, 2018, a funding milestone was met under the employment agreements for certain members of senior management. Accordingly, the employees were issued an aggregate of 550,162 fully vested Ordinary Shares. In connection with the Company’s initial public offering, on June 7, 2018, the Company issued 5,000,000 Ordinary Shares at an offering price of $15.00 per share for gross proceeds of $75,000,000, excluding offering costs of $9,541,530. Also as discussed in Note 3, on June 7, 2018, upon the effectiveness of the Company’s Registration Statement, 1,306,348 restricted Ordinary Shares, which represented 5% of the fully-diluted outstanding shares of the Company as of such date, were issued to certain members of senior management in accordance with their employment agreements. One-third Warrants On June 5, 2018, all of the outstanding warrants to purchase 927,594 Preferred Shares at an exercise price of approximately $10.48 per share were exercised for aggregate cash proceeds of $9,720,000. Preferred C Shares During the six-month Also, during the six-month On March 15, 2018, the Company issued 13,360 Preferred Shares in connection with a license agreement. On June 7, 2018, upon effectiveness of the Company’s Registration Statement on Form S-1, |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 6. Net Loss per Share The Company computes net loss per share in accordance with ASC 260-10, Earnings per Share Basic and diluted net loss per share is computed as follows: For the three-month periods ended June 30, 2018 2017 Net loss—basic and diluted $ (29,980,832 ) $ (7,178,719 ) Accretion of Preferred Shares financing costs (666,567 ) (30,401 ) Accretion of warrants (475,227 ) — Adjusted net loss—basic and diluted $ (31,122,626 ) $ (7,209,120 ) Weighted-average ordinary shares outstanding: Basic and Diluted 13,611,452 8,505,149 Net loss per share: Basic and Diluted $ (2.29 ) $ (0.85 ) For the six-month periods ended June 30, 2018 2017 Net loss—basic and diluted $ (46,384,185 ) $ (13,999,104 ) Accretion of Preferred Shares financing costs (761,012 ) (53,162 ) Accretion of warrants (1,045,500 ) — Adjusted net loss—basic and diluted $ (48,190,697 ) $ (14,052,266 ) Weighted-average ordinary shares outstanding: Basic and Diluted 11,280,804 8,545,437 Net loss per share: Basic and Diluted $ (4.27 ) $ (1.64 ) The following securities are considered to be Ordinary Share equivalents, but were not included in the computation of diluted net loss per Ordinary Share because to do so would have been anti-dilutive: June 30, 2018 June 30, 2017 Preferred Shares — 1,584,469 A restricted ordinary shares subject to forfeiture 870,898 245,828 Stock options 1,614,322 444,473 2,485,220 2,274,770 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 7. Income Taxes The Company did not record a provision for income taxes for the three months and six month ended June 30, 2018 and 2017, as the Company has generated losses for all periods. The Company periodically evaluates the realizability of its net deferred tax assets based on all available evidence, both positive and negative. The realization of net deferred tax assets is dependent on the Company’s ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets. The Company weighed both positive and negative evidence and determined that there is a continued need for a full valuation allowance on its deferred tax assets in the United States and United Kingdom as of June 30, 2018. Should the Company determine that it would be able to realize its remaining deferred tax assets in the foreseeable future, an adjustment to its remaining deferred tax assets would cause a material increase to income in the period such determination is made. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 8. Related Party Transactions: Transition Services Agreement Effective April 24, 2015, the Company entered into a three-year transition services agreement (the “TSA”) with Kadmon, whereby Kadmon would provide office and laboratory facilities as well as certain other personnel support activities to the Company. Under the agreement, the Company was charged for (i) rent based upon the square footage of the office and laboratory facilities used by the Company (ii) other personnel support activities based upon the hours of the personnel providing the support activities, and (iii) and other direct costs incurred by Kadmon on behalf of the Company, plus a 7% administrative fee. The TSA terminated on April 24, 2018 and the Company is currently leasing office space on a month to month basis from Kadmon. During the three-month periods ended June 30, 2018 and 2017, the Company incurred the following charges from Kadmon, which are included in loss from operations: 2018 2017 Rent $ 139,321 $ 152,169 Personnel — 6,746 Other — 126 Total charges incurred $ 139,321 $ 159,041 During the six-month 2018 2017 Rent $ 275,674 $ 275,524 Personnel 6,493 25,278 Other — 5,206 Total charges incurred $ 282,167 $ 306,008 During the three-month periods ended June 30, 2018 and 2017, the Company made cash payments totaling $145,887 and $0, respectively, to Kadmon. During the six-month The amount due to Kadmon at June 30, 2018 and December 31, 2017 is $0 and $861,030, respectively and is disclosed as Due to Kadmon on the Company’s condensed consolidated balance sheets. Research Agreement Effective October 23, 2016, the Company entered into a four-year master services agreement with UCL Consultants Limited, an entity affiliated with University College of London (“UCL”), which is a shareholder of the Company. Pursuant to the agreement, UCL Consultants Limited provides pre-clinical Total research and development expenses under this agreement for the three-month periods ended June 30, 2018 and 2017 were approximately $183,000 and $114,000, respectively. Total research and development expenses under this agreement for the six-month Future obligations, under the agreement equal £797,343, or approximately $1,052,791 through October 2020. The amount due to UCL under the master services agreement at June 30, 2018 and December 31, 2017 is $374,873 and $775,315, respectively, and is included in accounts payable and accrued expenses on the condensed consolidated balance sheets. Manufacturing Agreement Effective September 1, 2016, the Company entered into a manufacturing and drug supply agreement with UCL. Pursuant to the agreement, UCL manufactured materials for the Company’s clinical trials under the direction of the Company. Either party could terminate the agreement by giving 30 days written notice. The agreement was terminated in January 2018. Total research and development expenses under this agreement for the three-month periods ended June 30, 2018 and 2017 was approximately $0 and $479,494, respectively. Total research and development expenses under this agreement for the six-month The amount due to UCL under the manufacturing and drug supply agreement at June 30, 2018 and December 31, 2017 is $374,983 and $2,466,142, respectively, and is included in accrued expenses in the condensed consolidated balance sheet. License Agreement Effective March 15, 2018, the Company entered into an exclusive worldwide license agreement with UCL Business, PLC (“UCL Business”), to develop up to eight programs using certain ocular gene therapy technology. Under the terms of the agreement, the Company has agreed to pay UCL Business certain sales milestone payments, if achieved, in the aggregate amount of £39.8 million, or approximately $52.6 million using the exchange rate at June 30, 2018, and royalties on net sales, as defined upon commercialization. Additionally, the Company is responsible for all patent prosecution and maintenance costs incurred and has also agreed to pay UCL Business an annual maintenance fee of £50,000, or approximately $66,000, until the first commercial sale of a product. The agreement will terminate upon the later of (i) the last valid claim in a relevant product (ii) the expiration of regulatory exclusivity to all licensed products, or (iii) the 10 th The Company did not incur any research and development expenses under the agreement during the three-month and six-month Leases December 2016 Lease Effective December 15, 2016, the Company entered into another non-cancellable Total rent expense under this operating lease was $0 and $390,903 for the three-month periods ended June 30, 2018 and 2017, respectively. Total rent expense under this operating lease was $0 and $781,806 for the six-month On October 26, 2017, in connection with the amendment to the lease, the Company issued a promissory note in the amount of $1,442,009 to ARE. The note accrued interest at the rate of 5% per annum and was due on December 31, 2018. However, if the Company had sufficient liquidity, as defined in the note, then the note, including accrued interest, would become due and payable at that time. In accordance with the sufficient liquidity provision, the Company repaid the note, plus accrued interest, in the aggregate amount of $1,472,433 during the three-month period ended March 31, 2018. The Company recorded interest expense of $0 and $30,424 for the three-month and six-month July 2016 Lease Effective July 1, 2016, the Company entered into a non-cancellable Total rent expense under this operating lease was $121,890 and $121,890 for the three-month periods ended June 30, 2018 and 2017, respectively. Total rent expense under this operating lease was $243,780 and $243,780 for the six-month As of June 30, 2018, the aggregate future minimum rental payments under this lease are $1,927,187. In connection with the signing of this lease, the Company entered into a standby letter of credit agreement for $122,866, which serves as a security deposit for the premises. The standby letter of credit expires on July 7, 2017 and is automatically renewed annually through July 7, 2021. This standby letter of credit is secured with restricted cash in a money market account. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 9. Subsequent Events: Management has evaluated subsequent events through the date of this filing. Based on our evaluation, the following disclosures have been made: On July 27, 2018 two leases for office and laboratory facilities in London, UK expired. Effective July 27, 2018, the Company entered into two new non-cancellable |
Summary of Significant Accoun17
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
The Company | The Company MeiraGTx Holdings plc, a limited company under the laws of the Cayman Islands, is a clinical-stage biotech company developing novel gene therapy treatments for a wide range of inherited and acquired disorders for which there are no effective treatments available. The Company is focused on developing therapies for ocular diseases, including rare inherited blindness as well as Xerostomia following radiation treatment for head and neck cancers and neurodegenerative diseases such as amyothrophic lateral sclerosis (“ALS”). |
Risks and Uncertainties | Risks and Uncertainties The Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risks, including the potential risk of business failure. The Company’s limited capital resources and operations to date have been funded primarily with the proceeds from private equity offerings and the IPO. In the future, the Company may seek to raise additional capital through equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources to enable it to complete the development and potential commercialization of its product candidates. |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Reverse Share Split | Reverse Share Split On June 7, 2018 MeiraGTx Limited’s Board of Directors and shareholders approved a 1:3.881 reverse share split. All share information presented in these financial statements and accompanying footnotes have been retroactively adjusted to reflect the decreased number of shares resulting from this action. |
Liquidity | Liquidity The Company has not generated any revenues and has not yet achieved profitable operations. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of the Company’s product candidates will require significant additional financing. Management expects to incur substantial and increasing losses in future periods. The success of the Company is subject to certain risks and uncertainties, including among others, uncertainty of product development; competition in the Company’s field of use; uncertainty of capital availability; uncertainty in the Company’s ability to enter into agreements with collaborative partners; dependence on third parties; and dependence on key personnel. The Company has not generated positive cash flows from operations, and there are no assurances that the Company will be successful in obtaining an adequate level of financing for the development and commercialization of its product candidates. As of June 30, 2018, the Company had cash and cash equivalents in the amount of $102,060,551, which consisted of depository accounts. The Company estimates that its cash and cash equivalents on hand at June 30, 2018 will cover its expenses into the second quarter of 2020. |
Reorganization and Initial Public Offering | Reorganization and Initial Public Offering On May 28, 2018, the Board of Directors of MeiraGTx Limited approved the Reorganization Transactions, effective June 7, 2018, pursuant to which the Board of Directors approved the transfer of the shares held by each of the MeiraGTx Limited’s shareholders for the equivalent class and number of shares issued by Meira Holdings. On June 7, 2018, the Company completed its IPO, selling 5,000,000 Series A ordinary shares (“Ordinary Shares”) at a public offering price of $15.00 per share, and receiving $65.9 million in net proceeds, after deducting underwriting discounts and commissions and offering expenses payable by us. |
Interim Financial Statements | Interim Financial Statements The accompanying condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q S-X. six-month S-1 No. 333-224914), |
Consolidation | Consolidation The accompanying condensed consolidated financial statements include the accounts of Meira Holdings and its wholly owned subsidiaries: MeiraGTx Limited, a limited company under the laws of England and Wales (“Meira Limited); MeiraGTx, LLC, a Delaware corporation (“Meira LLC”); BRI-Alzan, Inc., a Delaware corporation (“BRI-Alzan”); MeiraGTx B.V., a Netherlands corporation (“Meira BV”); MeiraGTx UK II Limited, (“Meira UK II”), a limited company under the laws of England and Wales; MeiraGTx UK Limited (“Meira UK”), a limited company under the laws of England and Wales. All intercompany balances and transactions between the consolidated companies have been eliminated in consolidation. |
Use of Estimates | Use of Estimates Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the consolidated financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these consolidated financial statements, management used significant estimates in the following areas, among others: valuation of A ordinary shares (“Ordinary Shares”) issued prior to the Company’s initial public offering, for the acquisition of assets, the accounting for research and development costs, warrants, share based compensation, asset retirement obligations and accrued expenses. |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the price that would be received upon sale of an asset or paid upon transfer of a liability in an orderly transaction between market participants at the measurement date and in the principal or most advantageous market for that asset or liability. The fair value should be calculated based on assumptions that market participants would use in pricing the asset or liability, not on assumptions specific to the entity. In addition, the fair value of liabilities should include consideration of non-performance The Company follows ASC Topic 820, Fair Value Measurements and Disclosures • Level 1: Observable inputs such as quoted prices in active markets for identical assets the reporting entity has the ability to access as of the measurement date; • Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and • Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. The table below represents the values of the Compnay’s financial assets and liabilities that are required to be measured at fair value on a recurring basis: Fair Value Measurement Using: Description June 30, Significant Significant Other Significant Restricted cash $ 123,376 $ 123,376 $ — $ — Fair Value Measurement Using: Description December 31, Significant Significant Other Significant Restricted cash $ 123,376 $ 123,376 $ — $ — Warrants $ 2,679,633 $ — $ — $ 2,679,633 The table below represents a rollforward of the assets and liabilities that are required to be measured at fair value on a recurring basis from December 31, 2017 to June 30, 2018: Significant Balance as of December 31, 2017 $ 2,679,633 Change in fair value of warrants 1,514,775 Exercise of warrants (4,194,408 ) Balance as of June 30, 2018 $ — The warrants were classified as liabilities because the underlying Preferred Shares had a redemption feature in the event of a change of control of the Company. On June 5, 2018, the warrants were exercised at which time the warrant liability was determined to be $4,194,408, which represented the difference in the market value of the Preferred Shares and the exercise price of the warrants. This resulted in an increase of the warrant liability in the amount of $2,184,183 and $1,514,775 for the three-month and six-month The fair values of the warrants at December 31, 2017, March 31, 2018 and June 4, 2018 were estimated using the Black-Scholes valuation model with the following assumptions: December 31, 2017 March 31, 2018 June 4, 2018 Risk-free interest rate 1.72 % 1.86 % 1.77 % Expected volatility 80 % 80 % 80 % Expected dividend yield 0 0 0 Expected life 9 months 5.5 months 1 day For the unobservable inputs for the warrants, the expected volatility was determined at each measurement date by taking an average of the volatility of other publicly-traded peer biotechnology companies. The expected life was determined at each measurement date based upon the Company’s estimate of the time until the Company has a conversion event. The fair value of the Preferred Shares was based upon recent issuances of the Company’s Preferred Shares on or about December 31, 2017, March 31, 2018 and June 5, 2018. The estimated fair values of the Company’s warrants are not necessarily indicative of the amounts that would be realized in a current market exchange. The determination of the fair value of the warrants are sensitive to changes in in the assumptions used and a change in those inputs could result in a significantly higher or lower fair value measurement. If the volatility were to increase or the expected life were to increase, the fair value of the warrant would increase. Conversely, if the volatility were to decrease or the expected life were to decrease, the fair value of the warrant would decrease. |
Net Loss per Ordinary Share | Net Loss per Ordinary Share Basic net loss per Ordinary Share is computed by dividing net loss attributable to the Company’s shareholders by the weighted average number of shares of the Company’s Ordinary Shares assumed to be outstanding during the period of computation. Diluted net loss per ordinary share is computed similar to basic net loss per share except that the denominator is increased to include the number of additional Ordinary Shares that would have been outstanding if the potential ordinary shares had been issued at the beginning of the year and if the additional ordinary shares were dilutive (treasury stock method) or the two-class |
Asset Retirement Obligation | Asset Retirement Obligation Accounting for Asset Retirement Obligations requires legal obligations associated with the retirement of long-lived assets to be recognized at fair value when incurred and capitalized as part of the related long-lived asset. In the absence of quoted market prices, we estimate the fair value of our asset retirement obligations using Level 3 present value techniques, in which estimates of future cash flows associated with retirement activities are discounted using a credit-adjusted risk-free rate. Asset retirement obligations currently reported as other liabilities on our Consolidated Balance Sheet were measured during a period of historically low interest rates. The impact on measurements of new asset retirement obligations using different rates in the future may be significant. The Company uses estimates to determine the amount of the asset retirement obligations at the end of the lease term and discounts such asset retirement obligations using an estimated discount rate. Interest on the discounted asset retirement obligation is amortized over the term of the lease using the effective interest method and is recorded as interest expense in the consolidated statements of operations and comprehensive loss. The change in asset retirement obligations is as follows: For the six month period For the year ended Balance at beginning of period $ 178,419 $ 221,254 Amortization of interest 7,322 19,313 Change in estimate — (75,011 ) Effects of exchange rate (5,391 ) 12,863 Balance at end of period $ 180,350 $ 178,419 |
Research and Development | Research and Development Research and development costs are charged to expense as incurred. These costs include, but are not limited to, employee-related expenses, including salaries, benefits and travel of the Company’s research and development personnel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical and preclinical studies and manufacture the drug product for the clinical studies and preclinical activities; acquisition of in-process Costs for certain development activities, such as Company funded outside research programs, are recognized based on an evaluation of the progress to completion of specific tasks with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. |
Segment Information | Segment Information Management has concluded it has a single reporting segment for purposes of reporting financial condition and results of operations. The following table summarizes non-current June 30, 2018 December 31, 2017 United States $ 413,481 $ 436,463 United Kingdom 13,277,701 13,942,642 $ 13,691,182 $ 14,379,105 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2018, the FASB issued ASU 2018-07, 505-50 all 2018-07 In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business, ASU 2017-01 , ASU 2017-01 ASU 2017-01 also ASU 2017-01 should 2017-01 In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, or ASU 2016-20, that allows met. ASU 2016-20 also requires ASU 2014-09. ASU 2014-09. ASU 2016-20 In November 2016, the Financial Accounting Standards Board, or FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash ASU 2016-18, which the beginning-of-period and end-of-period amounts ASU 2016-18 also ASU 2016-18 will ASU 2016-18 In October 2016, the FASB issued ASU 2016-16, Income Intra-Entity Transfers of Assets Other than Inventory ASU 2016-16 which ASU 2016-16 to In May 2016, the FASB issued ASU No. 2016-12 , Revenue from Contracts with Customers (Topic 606), Narrow-Scope Improvements and Practical Expedients ASU 2016-12, which ASU No. 2014-09 Revenue from Contracts with Customers (Topic 606) ASU 2014-09, on ASU 2016-12 are ASU 2014-09, as ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date ASU 2015-14 . ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606), Identifying Performance Obligations and Licensing ASU 2016-10 , ASU 2016-10 requires 2016-10 categorizes ASU 2016-10 has ASU 2014-09, as ASU 2015-14. In ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606), Principal versus Agent Considerations (Reporting Revenue Gross versus Net) ASU 2016-08, which ASU 2014-09 ASU 2016-08 has ASU 2014-09, as ASU 2015-14. The In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers 2014-09, 2014-09 2014-09 2014-09 non-public 2014-09 2014-09 2014-09 |
Summary of Significant Accoun18
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Compnay's Financial Assets and Liabilities Measured at Fair Value | The table below represents the values of the Compnay’s financial assets and liabilities that are required to be measured at fair value on a recurring basis: Fair Value Measurement Using: Description June 30, Significant Significant Other Significant Restricted cash $ 123,376 $ 123,376 $ — $ — Fair Value Measurement Using: Description December 31, Significant Significant Other Significant Restricted cash $ 123,376 $ 123,376 $ — $ — Warrants $ 2,679,633 $ — $ — $ 2,679,633 |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The table below represents a rollforward of the assets and liabilities that are required to be measured at fair value on a recurring basis from December 31, 2017 to June 30, 2018: Significant Balance as of December 31, 2017 $ 2,679,633 Change in fair value of warrants 1,514,775 Exercise of warrants (4,194,408 ) Balance as of June 30, 2018 $ — |
Fair Values of Warrants Estimated by Using Black-Scholes Valuation Model | The fair values of the warrants at December 31, 2017, March 31, 2018 and June 4, 2018 were estimated using the Black-Scholes valuation model with the following assumptions: December 31, 2017 March 31, 2018 June 4, 2018 Risk-free interest rate 1.72 % 1.86 % 1.77 % Expected volatility 80 % 80 % 80 % Expected dividend yield 0 0 0 Expected life 9 months 5.5 months 1 day |
Schedule of change in asset retirement obligations | The change in asset retirement obligations is as follows: For the six month period For the year ended Balance at beginning of period $ 178,419 $ 221,254 Amortization of interest 7,322 19,313 Change in estimate — (75,011 ) Effects of exchange rate (5,391 ) 12,863 Balance at end of period $ 180,350 $ 178,419 |
Summary of Non-Current Assets by Geographical Area | The following table summarizes non-current June 30, 2018 December 31, 2017 United States 413,481 436,463 United Kingdom 13,277,701 13,942,642 13,691,182 14,379,105 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses for the period presented were comprised of the following: June 30, 2018 December 31, 2017 Clinical Trial Costs $ 2,297,893 $ 4,859,410 Compensation and Benefits 645,286 2,386,903 Consulting 1,137,547 1,220,477 Rent 128,683 387,267 Professional Fees 733,409 231,923 Interest 30,600 33,437 Travel 135,664 — Other 180,179 213,527 $ 5,289,261 $ 9,332,944 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Company's Share Option Activity Related to Employees, Non-Employee Members of the Board of Directors and Non-Employee Consultants | A summary of the Company’s share option activity related to employees, non-employee non-employee six-month Number of Options Weighted- Aggregate Outstanding at December 31, 2017 938,637 $ 5.12 $ 1,420,650 Granted 675,685 5.63 Exercised — — Expired — — Forfeited — — Outstanding at June 30, 2018 1,614,322 $ 5.34 $ 9,884,932 Weighted average remaining contractual life of options outstanding as of December 31, 2017 (yrs) 9.09 Weighted average remaining contractual life of options outstanding as of June 30, 2018 (yrs) 8.97 Options exercisable at December 31, 2017 186,395 $ 7.72 $ — Options exercisable at June 30, 2018 265,221 $ 7.69 $ 999,410 Weighted average remaining contractual life of options exercisable as of December 31, 2017 (yrs) 8.21 Weighted average remaining contractual life of options exercisable as of June 30, 2018 (yrs) 7.86 |
Schedule of Grant Date Fair Values of the Stock Option Granted | The grant date fair values of the stock options granted to those groups were estimated using the Black-Scholes option valuation model with the following ranges of assumptions: 2018 Risk-free interest rate 2.32% - 2.40% Expected volatility 90% Expected dividend yield 0% Expected life of employee and Board of Directors’ options (in years) 5.5 - 6.1 2018 2017 Risk-free interest rate 2.80% - 2.84% 2.29% - 2.31% Expected volatility 90% 80% Expected dividend yield 0% 0% Expected life of non-employee 7.7 - 9.5 8.7 - 9.7 |
Summary of Restricted Ordinary Shares | A summary of the restricted Ordinary Shares is as follows: Ordinary Shares $ Value Non-vested 105,913 $ 865,861 Issued during the six-month 1,306,348 19,595,220 Vesting during the six-month (541,363 ) (7,397,611 ) Non-vested 870,898 $ 13,063,470 |
Schedule of Share Based Compensation Expense | During the three-month and six-month Three-month periods ended June 30, 2018 2017 Research and development $ 1,045,561 $ 550,708 General and administrative 7,318,224 131,427 Total share based compensation $ 8,363,785 $ 682,135 Six-month periods ended June 30, 2018 2017 Research and development $ 1,890,511 $ 1,239,923 General and administrative 10,743,045 295,167 Total share based compensation $ 12,633,556 $ 1,535,090 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Loss per Share | Basic and diluted net loss per share is computed as follows: For the three-month periods ended June 30, 2018 2017 Net loss—basic and diluted $ (29,980,832 ) $ (7,178,719 ) Accretion of Preferred Shares financing costs (666,567 ) (30,401 ) Accretion of warrants (475,227 ) — Adjusted net loss—basic and diluted $ (31,122,626 ) $ (7,209,120 ) Weighted-average ordinary shares outstanding: Basic and Diluted 13,611,452 8,505,149 Net loss per share: Basic and Diluted $ (2.29 ) $ (0.85 ) For the six-month periods ended June 30, 2018 2017 Net loss—basic and diluted $ (46,384,185 ) $ (13,999,104 ) Accretion of Preferred Shares financing costs (761,012 ) (53,162 ) Accretion of warrants (1,045,500 ) — Adjusted net loss—basic and diluted $ (48,190,697 ) $ (14,052,266 ) Weighted-average ordinary shares outstanding: Basic and Diluted 11,280,804 8,545,437 Net loss per share: Basic and Diluted $ (4.27 ) $ (1.64 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings per Share | The following securities are considered to be Ordinary Share equivalents, but were not included in the computation of diluted net loss per Ordinary Share because to do so would have been anti-dilutive: June 30, 2018 June 30, 2017 Preferred Shares — 1,584,469 A restricted ordinary shares subject to forfeiture 870,898 245,828 Stock options 1,614,322 444,473 2,485,220 2,274,770 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Related Party Transactions [Abstract] | |
Incurred Charges Included in Loss from Operations | During the three-month periods ended June 30, 2018 and 2017, the Company incurred the following charges from Kadmon, which are included in loss from operations: 2018 2017 Rent $ 139,321 $ 152,169 Personnel — 6,746 Other — 126 Total charges incurred $ 139,321 $ 159,041 During the six-month 2018 2017 Rent $ 275,674 $ 275,524 Personnel 6,493 25,278 Other — 5,206 Total charges incurred $ 282,167 $ 306,008 |
Organization and Basis of Pre23
Organization and Basis of Presentation - Additional Information (Detail) | Jun. 07, 2018USD ($)$ / sharesshares | Mar. 01, 2018shares | Jun. 30, 2018USD ($) | Dec. 31, 2017USD ($) |
Schedule Of Description Of Business [Line Items] | ||||
Reverse share split ratio | 0.257 | |||
Cash and cash equivalents | $ 102,060,551 | $ 8,548,638 | ||
A Ordinary Shares [Member] | ||||
Schedule Of Description Of Business [Line Items] | ||||
Ordinary shares, issued | shares | 5,000,000 | 550,162 | ||
Ordinary shares, offering price | $ / shares | $ 15 | |||
Proceeds from issuance initial public offering net | $ 65,900,000 |
Summary of Significant Accoun24
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Company's Financial Instruments Carried at Fair Value Measurements (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Restricted Cash [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, net asset (liability) | $ 123,376 | $ 123,376 |
Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, net asset (liability) | 2,679,633 | |
Fair Value, Inputs, Level 1 [Member] | Restricted Cash [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, net asset (liability) | $ 123,376 | 123,376 |
Fair Value, Inputs, Level 3 [Member] | Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, net asset (liability) | $ 2,679,633 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018USD ($) | Jun. 30, 2018USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Change in fair value of warrants | $ 2,184,183 | $ 1,514,775 |
Fair Value, Inputs, Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Beginning balance | 2,679,633 | |
Change in fair value of warrants | 1,514,775 | |
Exercise of warrants | (4,194,408) | |
Ending balance | $ 0 | $ 0 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2018 | Jun. 05, 2018 | Dec. 31, 2017 | |
Warrant liability | $ 4,194,408 | $ 2,679,633 | ||
Change in fair value of warrants | $ 2,184,183 | $ 1,514,775 | ||
Exercise of warrants liability | 4,194,408 | |||
Capital in Excess of Nominal Value [Member] | ||||
Exercise of warrants liability | $ 4,194,408 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Fair Values of Warrants Estimated by Using Black-Scholes Valuation Model (Detail) - Warrants [Member] | Jun. 04, 2018 | Mar. 31, 2018 | Dec. 31, 2017 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Risk-free interest rate | 1.77% | 1.86% | 1.72% |
Expected volatility | 80.00% | 80.00% | 80.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected life | 1 day | 5 months 15 days | 9 months |
Summary of Significant Accoun28
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Change in Asset Retirement Obligations (Detail) - USD ($) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Asset Retirement Obligation [Abstract] | |||
Balance at beginning of period | $ 178,419 | $ 221,254 | $ 221,254 |
Amortization of interest | 7,322 | $ 9,255 | 19,313 |
Change in estimate | (75,011) | ||
Effects of exchange rate | (5,391) | 12,863 | |
Balance at end of period | $ 180,350 | $ 178,419 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Non-Current Assets by Geographical Area (Detail) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Operation By Geographical [Line Items] | ||
Non current assets | $ 13,691,182 | $ 14,379,105 |
United States | ||
Operation By Geographical [Line Items] | ||
Non current assets | 413,481 | 436,463 |
United Kingdom | ||
Operation By Geographical [Line Items] | ||
Non current assets | $ 13,277,701 | $ 13,942,642 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Clinical Trial Costs | $ 2,297,893 | $ 4,859,410 |
Compensation and Benefits | 645,286 | 2,386,903 |
Consulting | 1,137,547 | 1,220,477 |
Rent | 128,683 | 387,267 |
Professional Fees | 733,409 | 231,923 |
Interest | 30,600 | 33,437 |
Travel | 135,664 | |
Other | 180,179 | 213,527 |
Accrued expenses | $ 5,289,261 | $ 9,332,944 |
Share based Compensation - Addi
Share based Compensation - Additional Information (Detail) - USD ($) | Jun. 07, 2018 | Mar. 01, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Weighted average remaining contractual life of options outstanding | 8 years 11 months 19 days | 9 years 1 month 2 days | ||||||
Fair value of options Vested | $ 247,202 | $ 229,250 | $ 556,349 | $ 927,915 | ||||
Share options granted during the period | 675,685 | |||||||
Fully-diluted outstanding shares | 5.00% | |||||||
Share based compensation | $ 12,633,556 | 1,535,090 | ||||||
Excess Tax Benefit from Share-based Compensation, Operating Activities | 0 | 0 | 0 | 0 | ||||
Excess Tax Benefit from Share-based Compensation, Financing Activities | 0 | $ 0 | $ 0 | $ 0 | ||||
Maximum [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Weighted average remaining contractual life of options outstanding | 10 years | |||||||
A Ordinary Shares [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Ordinary shares awarded, per share | $ 15 | |||||||
Fully-diluted outstanding shares | 3.00% | |||||||
Share based compensation | $ 3,096,104 | $ 6,456,215 | ||||||
Ordinary shares, issued | 5,000,000 | 550,162 | ||||||
A Ordinary Shares [Member] | General and Administrative Expense [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share based compensation | $ 3,096,012 | |||||||
Restricted Shares [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Ordinary shares | 1,306,348 | 1,306,348 | ||||||
Ordinary shares forfeiture period | 3 years | |||||||
Ordinary shares awarded, per share | $ 15 | |||||||
Fully-diluted outstanding shares | 5.00% | |||||||
Share based compensation | 13,620,866 | |||||||
Restricted Shares [Member] | General and Administrative Expense [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share based compensation | $ 6,531,750 | |||||||
Restricted Shares [Member] | A Ordinary Shares [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Ordinary shares | 867,935 | |||||||
Employee and Non Employee Board of Directors [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share options granted during the period | 0 | 0 | 533,330 | 0 | ||||
Total unvested options compensation expense | $ 2,596,655 | $ 2,596,655 | ||||||
Unvested options expected to be realized | 3 years 6 months | |||||||
Weighted average grant date fair value of options granted | $ 5.63 | $ 6.13 | ||||||
Non-employee consultants [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share options granted during the period | 0 | 142,355 | 135,271 | |||||
Total unvested options compensation expense | $ 3,823,995 | $ 3,823,995 | ||||||
Unvested options expected to be realized | 3 years 6 months | |||||||
Consultant [Member] | Restricted Shares [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Ordinary shares awarded, per share | $ 7.72 | $ 7.72 | ||||||
Employee [Member] | Restricted Shares [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Ordinary shares awarded, per share | $ 7.76 | $ 7.76 | ||||||
First Anniversary [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting percentage | 25.00% | |||||||
Over Three Years [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting period | 36 months |
Share Based Compensation - Summ
Share Based Compensation - Summary of Company's Share Option Activity Related to Employees, Non-Employee Members of the Board of Directors and Non-Employee Consultants (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018 | Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Number of options, Beginning balance | 938,637 | ||
Number of options, Granted | 675,685 | ||
Number of options, Exercised | 0 | ||
Number of options, Expired | 0 | ||
Number of options, Forfeited | 0 | ||
Number of options, Ending balance | 1,614,322 | 1,614,322 | 938,637 |
Weighted average remaining contractual life of options outstanding | 8 years 11 months 19 days | 9 years 1 month 2 days | |
Number of options, Options exercisable | 265,221 | 186,395 | |
Weighted average remaining contractual life of options exercisable | 7 years 10 months 9 days | 8 years 2 months 15 days | |
Weighted- average exercise price, beginning balance | $ 5.12 | ||
Weighted- average exercise price, granted | 5.63 | ||
Weighted- average exercise price, exercised | 0 | ||
Weighted- average exercise price, expired | 0 | ||
Weighted- average exercise price, forfeited | 0 | ||
Weighted- average exercise price, ending balance | $ 5.34 | $ 5.12 | $ 5.12 |
Weighted- average exercise price, option exercisable | $ 7.69 | $ 7.72 | |
Aggregate Intrinsic Value, Beginning balance | $ 1,420,650 | ||
Aggregate Intrinsic Value, Ending balance | $ 9,884,932 | $ 9,884,932 | $ 1,420,650 |
Aggregate Intrinsic Value, Options exercisable | $ 999,410 |
Share Based Compensation - Sche
Share Based Compensation - Schedule of Grant Date Fair Values of the Stock Option Granted Black Scholes Valuation Model (Detail) | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Employee and Board of Directors [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.32% | |
Risk-free interest rate | 2.40% | |
Expected volatility | 90.00% | |
Expected dividend yield | 0.00% | |
Non Employee [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.80% | 2.29% |
Risk-free interest rate | 2.84% | 2.31% |
Expected volatility | 90.00% | 80.00% |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | Employee and Board of Directors [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life of employee and Board of Directors' options (in years) | 5 years 6 months | |
Minimum [Member] | Non Employee [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life of employee and Board of Directors' options (in years) | 7 years 8 months 12 days | 8 years 8 months 12 days |
Maximum [Member] | Employee and Board of Directors [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life of employee and Board of Directors' options (in years) | 6 years 1 month 6 days | |
Maximum [Member] | Non Employee [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life of employee and Board of Directors' options (in years) | 9 years 6 months | 9 years 8 months 12 days |
Share Based Compensation - Su34
Share Based Compensation - Summary of Restricted Ordinary Shares (Detail) - Restricted Shares [Member] - USD ($) | Jun. 07, 2018 | Jun. 30, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Non-vested Ordinary Shares, Beginning Balance | 105,913 | |
Issued, Ordinary Shares | 1,306,348 | 1,306,348 |
Vesting, Ordinary Shares | (541,363) | |
Non-vested Ordinary Shares, Ending Balance | 870,898 | |
Non-vested Value, Beginning Balance | $ 865,861 | |
Issued, Value | 19,595,220 | |
Vesting, Value | (7,397,611) | |
Non-vested Value, Ending Balance | $ 13,063,470 |
Share Based Compensation - Sc35
Share Based Compensation - Schedule of Share Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Share Based Compensation Expense [Line Items] | ||||
Total share based compensation | $ 8,363,785 | $ 682,135 | $ 12,633,556 | $ 1,535,090 |
Research and Development Expense [Member] | ||||
Share Based Compensation Expense [Line Items] | ||||
Total share based compensation | 1,045,561 | 550,708 | 1,890,511 | 1,239,923 |
General and Administrative Expense [Member] | ||||
Share Based Compensation Expense [Line Items] | ||||
Total share based compensation | $ 7,318,224 | $ 131,427 | $ 10,743,045 | $ 295,167 |
Ordinary Shares and Convertib36
Ordinary Shares and Convertible Preferred C Shares - Additional Information (Detail) - USD ($) | Jun. 07, 2018 | Jun. 05, 2018 | Mar. 15, 2018 | Mar. 01, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2015 |
Percentage of fully diluted shares | 5.00% | ||||||||
Preferred shares, purchase | 927,594 | ||||||||
Preferred shares, exercise price | $ 10.48 | ||||||||
Preferred shares, value | $ 9,720,000 | $ 9,720,000 | |||||||
Gross proceeds from preferred shares | 56,849,592 | $ 210,244 | |||||||
Preferred share conversion value | $ 664,718 | $ 666,567 | $ 30,401 | $ 761,012 | 53,162 | ||||
Restricted Shares [Member] | |||||||||
Ordinary shares, offering price | $ 15 | ||||||||
Ordinary shares | 1,306,348 | 1,306,348 | |||||||
Percentage of fully diluted shares | 5.00% | ||||||||
A Ordinary Shares [Member] | |||||||||
Ordinary shares, issued | 5,000,000 | 550,162 | |||||||
Ordinary shares, offering price | $ 15 | ||||||||
Proceeds from issuance initial public offering | $ 75,000,000 | ||||||||
Offering costs | $ 9,541,530 | $ 2,781,553 | |||||||
Percentage of fully diluted shares | 3.00% | ||||||||
Preferred shares conversion into ordinary shares | 11,501,432 | 11,501,432 | |||||||
A Ordinary Shares [Member] | Restricted Shares [Member] | |||||||||
Ordinary shares | 867,935 | ||||||||
Preferred C Shares [Member] | |||||||||
Ordinary shares, issued | 5,425,124 | ||||||||
Ordinary shares, offering price | $ 10.48 | $ 10.48 | |||||||
Offering costs | $ 690,473 | ||||||||
Gross proceeds from preferred shares | 56,849,592 | ||||||||
Convertible Preferred C Shares [Member] | |||||||||
Offering costs | $ 610,473 | $ 6,124 | |||||||
Preferred shares, purchase | 927,594 | ||||||||
Preferred shares conversion into ordinary shares | (11,501,432) | ||||||||
Convertible Preferred C Shares [Member] | License Agreement [Member] | |||||||||
Ordinary shares, issued | 13,360 | 13,360 | |||||||
Convertible Preferred C Shares [Member] | Payments In Lieu [Member] | |||||||||
Ordinary shares, issued | 129,419 | ||||||||
Shares issued, value | $ 1,356,129 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Basic and Diluted Net Loss per Share (Detail) - USD ($) | Jun. 07, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 |
Earnings Per Share [Abstract] | |||||
Net loss-basic and diluted | $ (29,980,832) | $ (7,178,719) | $ (46,384,185) | $ (13,999,104) | |
Accretion of Preferred Shares financing costs | $ (664,718) | (666,567) | (30,401) | (761,012) | (53,162) |
Accretion of warrants | (475,227) | (1,045,500) | |||
Adjusted net loss-basic and diluted | $ (31,122,626) | $ (7,209,120) | $ (48,190,697) | $ (14,052,266) | |
Weighted-average ordinary shares outstanding: | |||||
Basic and Diluted | 13,611,452 | 8,505,149 | 11,280,804 | 8,545,437 | |
Net loss per share: | |||||
Basic and Diluted | $ (2.29) | $ (0.85) | $ (4.27) | $ (1.64) |
Net Loss per Share - Schedule38
Net Loss per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings per Share (Detail) - shares | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 2,485,220 | 2,274,770 |
Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 1,584,469 | |
Restricted Shares [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 870,898 | 245,828 |
Stock Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 1,614,322 | 444,473 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Income Tax Disclosure [Abstract] | ||||
Provision for Income Taxes | $ 0 | $ 0 | $ 0 | $ 0 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) | Apr. 24, 2015 | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2018USD ($) | Jun. 30, 2018USD ($)Program | Jun. 30, 2017USD ($) | Dec. 31, 2017GBP (£) | Dec. 31, 2017USD ($) | Dec. 31, 2016GBP (£) | Dec. 31, 2016USD ($) | Oct. 31, 2020GBP (£) | Oct. 31, 2020USD ($) | Jun. 30, 2018GBP (£) | Jun. 30, 2018USD ($) | Oct. 26, 2017USD ($) |
Related Party Transaction [Line Items] | ||||||||||||||||
Amount due under services agreement | $ 861,030 | $ 0 | ||||||||||||||
Related party transaction amounts of work orders issued | $ 139,321 | $ 159,041 | $ 282,167 | $ 306,008 | ||||||||||||
Research and development expenses | 7,790,694 | 5,363,545 | 14,718,016 | 10,186,902 | ||||||||||||
Interest expense | 9,708 | 50,894 | $ 37,063 | 59,020 | ||||||||||||
July 2016 Lease [Member] | ||||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||||
Operating lease expiration date | Dec. 31, 2021 | |||||||||||||||
Operating leases rent expense payment description | The Company records monthly rent expense on a straight-line basis from July 1, 2016 through December 31, 2021. | |||||||||||||||
Deferred rent | 231,276 | 220,722 | ||||||||||||||
Operating lease rent expenses | 121,890 | 121,890 | $ 243,780 | 243,780 | ||||||||||||
Aggregate future minimum rental payments under operating lease | 1,927,187 | |||||||||||||||
Letter of credit outstanding amount | 122,866 | |||||||||||||||
December 2016 [Member] | ||||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||||
Operating lease expiration date | Oct. 31, 2032 | |||||||||||||||
Operating leases rent expense payment description | The Company recorded monthly rent expense on a straight-line basis from December 15, 2016 through October 31, 2032. | |||||||||||||||
Operating lease termination date | Mar. 31, 2018 | |||||||||||||||
Base rent and management fees | $ 563,507 | |||||||||||||||
Promissory note issued | $ 1,442,009 | |||||||||||||||
Deferred rent | 0 | 0 | ||||||||||||||
Operating lease rent expenses | 0 | 390,903 | $ 0 | 781,806 | ||||||||||||
Promissory note rate of interest | 5.00% | |||||||||||||||
Promissory note expiration due date | Dec. 31, 2018 | |||||||||||||||
Repayment of promissory note | $ 1,472,433 | |||||||||||||||
Interest expense | 0 | $ 30,424 | ||||||||||||||
UCL Consultants Limited [Member] | Research Agreement [Member] | ||||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||||
Amount due under services agreement | 775,315 | 374,873 | ||||||||||||||
Related party transaction amounts of work orders issued | £ 241,053 | 311,000 | £ 1,161,149 | $ 1,574,000 | ||||||||||||
Agreement termination notice period | 30 days | |||||||||||||||
Research and development expenses | 183,000 | 114,000 | $ 372,000 | 222,000 | ||||||||||||
UCL Consultants Limited [Member] | Manufacturing Agreement [Member] | ||||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||||
Amount due under services agreement | $ 2,466,142 | 374,983 | ||||||||||||||
Agreement termination notice period | 30 days | |||||||||||||||
Research and development expenses | 0 | 479,494 | $ 0 | 1,042,518 | ||||||||||||
Agreement termination date | 2018-01 | |||||||||||||||
UCL Consultants Limited [Member] | License Agreement [Member] | ||||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||||
Research and development expenses | 0 | 0 | $ 0 | 0 | ||||||||||||
Number of programs | Program | 8 | |||||||||||||||
Potential milestone payment upon achievement of milestone | £ 39,800,000 | 52,600,000 | ||||||||||||||
Annual maintenance fee | £ 50,000 | $ 66,000 | ||||||||||||||
UCL Consultants Limited [Member] | Scenario, Forecast [Member] | Research Agreement [Member] | ||||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||||
Future obligations under agreement | £ 797,343 | $ 1,052,791 | ||||||||||||||
Kadmon [Member] | Transition Services Agreement with Related Party [Member] | ||||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||||
Percentage of administrative fees | 7.00% | |||||||||||||||
Services agreement period | 3 years | |||||||||||||||
Services termination date | Apr. 24, 2018 | |||||||||||||||
Cash payment | $ 145,887 | $ 0 | $ 1,143,304 | $ 275,941 |
Related Party Transactions - In
Related Party Transactions - Incurred Charges included in Loss from Operations (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Related Party Transaction [Line Items] | ||||
Total charges incurred | $ 139,321 | $ 159,041 | $ 282,167 | $ 306,008 |
Rent [Member] | ||||
Related Party Transaction [Line Items] | ||||
Total charges incurred | $ 139,321 | 152,169 | 275,674 | 275,524 |
Personnel [Member] | ||||
Related Party Transaction [Line Items] | ||||
Total charges incurred | 6,746 | $ 6,493 | 25,278 | |
Other [Member] | ||||
Related Party Transaction [Line Items] | ||||
Total charges incurred | $ 126 | $ 5,206 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] - July 27, 2018 Lease [Member] | Jul. 27, 2018USD ($)Lease |
Subsequent Event [Line Items] | |
Deferred rent | $ | $ 363,000 |
Operating lease termination date | May 24, 2027 |
Number of leases expired | 2 |
Number of new leases | 2 |