Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 15, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | MGTX | ||
Entity Registrant Name | MeiraGTx Holdings plc | ||
Entity Central Index Key | 0001735438 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Common Stock, Shares Outstanding | 33,183,734 | ||
Entity Public Float | $ 154.6 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 68,080,175 | $ 8,548,638 |
Prepaid expenses | 1,937,785 | 1,961,243 |
Other current assets | 4,634,105 | 965,233 |
Total Current Assets | 74,652,065 | 11,475,114 |
Property, plant and equipment, net | 22,014,237 | 14,255,729 |
Security deposits | 105,085 | |
Restricted cash | 123,376 | 123,376 |
TOTAL ASSETS | 96,894,763 | 25,854,219 |
CURRENT LIABILITIES: | ||
Accounts payable | 3,042,861 | 7,055,380 |
Accrued expenses | 11,991,697 | 9,332,944 |
Note payable | 1,442,009 | |
Warrant liability | 2,679,633 | |
Capitalized lease obligation-current portion | 27,199 | 30,850 |
Due to Kadmon | 0 | 861,030 |
Other current liabilities | 437,053 | |
Total Current Liabilities | 15,498,810 | 21,401,846 |
Capitalized lease obligation | 7,097 | 34,298 |
Deferred rent | 201,264 | 266,290 |
Asset retirement obligation | 128,119 | 178,419 |
TOTAL LIABILITIES | 15,835,290 | 21,880,853 |
COMMITMENTS | ||
Convertible Preferred C Shares 0 and 5,005,935 outstanding at December 31, 2018 and December 31, 2017, respectively (liquidation preference of $52,455,700 at December 31, 2017) | 51,338,631 | |
SHAREHOLDERS' EQUITY (DEFICIT): | ||
Ordinary Shares, $0.00003881 nominal value, 1,288,327,750 authorized 27,386,632 issued and outstanding at December 31, 2018 8,826,190 issued and 8,714,563 issued and outstanding at December 31, 2017 | 1,064 | 342 |
Capital in excess of nominal value | 229,054,460 | 20,080,713 |
Accumulated other comprehensive income (loss) | 293,666 | (2,022,477) |
Accumulated deficit | (148,289,717) | (65,423,843) |
Total Shareholders' Equity (Deficit) | 81,059,473 | (47,365,265) |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS' EQUITY (DEFICIT) | $ 96,894,763 | $ 25,854,219 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 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 authorized | 1,288,327,750 | 1,288,327,750 |
Common stock, shares issued | 27,386,632 | 8,826,190 |
Common stock, shares outstanding | 27,386,632 | 8,714,563 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating expenses: | ||
General and administrative | $ 44,483,938 | $ 9,325,017 |
Research and development | 33,620,223 | 22,359,712 |
Total operating expenses | 78,104,161 | 31,684,729 |
Loss from operations | (78,104,161) | (31,684,729) |
Other non-operating income (expense): | ||
Other income | 83,075 | |
Foreign currency (loss) gain | (3,824,383) | 1,676,117 |
Convertible note inducement expense | (553,500) | |
Change in fair value of warrant liability | (1,514,775) | (465,633) |
Interest income | 53,408 | 26,073 |
Interest expense | (33,429) | (42,863) |
Loss before income taxes | (83,340,265) | (31,044,535) |
Benefit for income taxes | 474,391 | 0 |
Net loss | (82,865,874) | (31,044,535) |
Other comprehensive income (loss): | ||
Foreign currency translation, net of tax of $474,391 and $0 in 2018 and 2017, respectively | 2,316,143 | (1,361,365) |
Total comprehensive loss | (80,549,731) | (32,405,900) |
Net loss | (82,865,874) | (31,044,535) |
Accretion on convertible preferred C shares and warrants | (1,806,512) | (806,963) |
Adjusted net loss | $ (84,672,386) | $ (31,851,498) |
Basic and diluted net loss per ordinary share | $ (4.47) | $ (3.72) |
Weighted-average number of ordinary shares outstanding | 18,948,520 | 8,572,315 |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Foreign currency translation, tax | $ 474,391 | $ 0 |
CONSOLIDATED STATEMENTS OF CONV
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS' EQUITY (DEFICIT) - USD ($) | Total | Vector Neurosciences Acquisition [Member] | IPO [Member] | Ordinary shares [Member] | Ordinary shares [Member]Vector Neurosciences Acquisition [Member] | Ordinary shares [Member]IPO [Member] | Capital in Excess of Nominal Value [Member] | Capital in Excess of Nominal Value [Member]Vector Neurosciences Acquisition [Member] | Capital in Excess of Nominal Value [Member]IPO [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [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] |
Temporary equity, beginning Balance at Dec. 31, 2016 | $ 32,833,660 | ||||||||||||||
Beginning Balance at Dec. 31, 2016 | $ (17,139,083) | $ 342 | $ 17,900,995 | $ (661,112) | $ (34,379,308) | ||||||||||
Temporary equity, beginning Balance, Shares at Dec. 31, 2016 | 1,574,739 | ||||||||||||||
Beginning Balance, Shares at Dec. 31, 2016 | 8,818,461 | ||||||||||||||
Exercised stock options | $ 9,950 | 9,950 | |||||||||||||
Exercised stock options, shares | 1,288 | 1,288 | |||||||||||||
Issuance of A ordinary shares in connection with a license agreement | $ 17,000 | 17,000 | |||||||||||||
Issuance of A ordinary shares in connection with a license agreement, shares | 6,441 | ||||||||||||||
Extinguishment of convertible preferred C shares, net of unaccreted issuance costs | 33,115,157 | 33,115,157 | $ (33,115,157) | ||||||||||||
Extinguishment of convertible preferred C shares, net of unaccreted issuance costs, shares | (1,584,469) | ||||||||||||||
Issuance of convertible preferred C shares in connection with extinguishment | (33,206,360) | (33,206,360) | $ 33,206,360 | ||||||||||||
Issuance of convertible preferred C shares in connection with extinguishment, shares | 3,168,929 | ||||||||||||||
Conversion of convertible preferred C shares into A ordinary shares | $ 2,500,000 | ||||||||||||||
Conversion of convertible preferred C shares into A ordinary shares, shares | 238,579 | ||||||||||||||
Issuance of convertible preferred C shares, net of warrants and issuance costs | $ 15,198,008 | ||||||||||||||
Issuance of convertible preferred C shares, net of warrants and issuance costs, shares | 1,608,157 | ||||||||||||||
Accretion of issuance costs on convertible preferred C shares | (100,760) | (100,760) | |||||||||||||
Accretion of warrants issued in connection with convertible preferred C shares | (615,000) | (615,000) | |||||||||||||
Accretion of issuance costs on convertible preferred C shares | $ 100,760 | ||||||||||||||
Accretion of warrants issued in connection with convertible preferred C shares | 615,000 | ||||||||||||||
Share-based compensation | 2,959,731 | 2,959,731 | |||||||||||||
Foreign currency translation, net of income taxes | (1,361,365) | (1,361,365) | |||||||||||||
Net loss | (31,044,535) | (31,044,535) | |||||||||||||
Temporary equity, beginning Balance at Dec. 31, 2017 | $ 51,338,631 | ||||||||||||||
Ending Balance at Dec. 31, 2017 | $ (47,365,265) | $ 342 | 20,080,713 | (2,022,477) | (65,423,843) | ||||||||||
Temporary equity, beginning Balance, Shares at Dec. 31, 2017 | 5,005,935 | 5,005,935 | |||||||||||||
Ending Balance, Shares at Dec. 31, 2017 | 8,826,190 | ||||||||||||||
Issuance of convertible preferred C shares, net of issuance costs | $ 1,356,129 | $ 140,000 | $ 56,159,119 | ||||||||||||
Sale of ordinary shares in initial public offering, net of issuance costs | $ 65,192,378 | $ 194 | $ 65,192,184 | ||||||||||||
Issuance of shares, net of issuance costs, shares | 5,000,000 | 129,419 | 13,360 | 5,425,124 | |||||||||||
Conversion of convertible preferred C shares into A ordinary shares | $ 120,520,391 | $ 446 | 120,519,945 | $ (120,520,391) | |||||||||||
Conversion of convertible preferred C shares into A ordinary shares, shares | 11,501,432 | (11,501,432) | |||||||||||||
Accretion of issuance costs on convertible preferred C shares | (761,012) | (761,012) | |||||||||||||
Accretion of warrants issued in connection with convertible preferred C shares | (1,045,500) | (1,045,500) | |||||||||||||
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 | 4,194,408 | $ 9,720,000 | ||||||||||||
Exercise of warrants, Share | 927,594 | ||||||||||||||
Issuance of ordinary shares in connection with Vector Neurosciences acquisition | $ 2,990,250 | $ 9 | $ 2,990,241 | ||||||||||||
Issuance of ordinary shares in connection with Vector Neurosciences acquisition, Shares | 202,500 | ||||||||||||||
Share-based compensation | 17,883,554 | $ 73 | 17,883,481 | ||||||||||||
Share-based compensation, Shares | 1,856,510 | ||||||||||||||
Foreign currency translation, net of income taxes | 2,316,143 | 2,316,143 | |||||||||||||
Net loss | (82,865,874) | (82,865,874) | |||||||||||||
Ending Balance at Dec. 31, 2018 | $ 81,059,473 | $ 1,064 | $ 229,054,460 | $ 293,666 | $ (148,289,717) | ||||||||||
Temporary equity, beginning Balance, Shares at Dec. 31, 2018 | 0 | ||||||||||||||
Ending Balance, Shares at Dec. 31, 2018 | 27,386,632 |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS' EQUITY (DEFICIT) (Parenthetical) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
IPO [Member] | |
Sale of ordinary shares in initial public offering, issuance costs | $ 9,807,622 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (82,865,874) | $ (31,044,535) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Preferred C shares issued in connection with a license agreement | 140,000 | |
Issuance of shares for services | 17,000 | |
Share-based compensation expense | 17,883,554 | 2,959,731 |
Foreign currency loss (gain) | 3,824,383 | (1,676,117) |
Depreciation | 2,053,220 | 679,177 |
Amortization of interest on asset retirement obligation | (38,301) | 19,313 |
Change in fair value of warrant liability | 1,514,775 | 465,633 |
Convertible note inducement expense | 553,500 | |
Issuance of shares for acquired research and development expense | 2,990,250 | |
Issuance of note payable in connection with lease termination | 1,442,009 | |
Benefit for income taxes | (474,391) | 0 |
(Increase) in operating assets: | ||
Prepaid expenses | (35,465) | (669,756) |
Other current assets | (3,684,465) | (493,424) |
Security deposits | (115,573) | |
Increase (decrease) in operating liabilities: | ||
Accounts payable | (2,119,493) | 4,728,491 |
Accrued expenses | 2,529,568 | 4,969,619 |
Due to Kadmon | (861,030) | 317,992 |
Other liabilities | 436,161 | |
Deferred rent | (65,189) | (324,019) |
Net cash used in operating activities | (58,887,870) | (18,055,386) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (11,258,479) | (10,535,717) |
Net cash used in investing activities | (11,258,479) | (10,535,717) |
Cash flows from financing activities: | ||
Payments on capitalized lease obligation | (30,852) | (24,388) |
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 | 56,849,594 | 16,854,653 |
(Payment) issuance of note payable | (1,442,009) | 2,500,000 |
Proceeds from excercised stock options | 9,950 | |
Net cash provided by financing activities | 130,040,415 | 19,340,215 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 59,894,066 | (9,250,888) |
Effect of exchange rate changes on cash | (362,529) | 1,417 |
Cash, cash equivalents and restricted cash at beginning of year | 8,672,014 | 17,921,485 |
Cash, cash equivalents and restricted cash at end of year | 68,203,551 | 8,672,014 |
Supplemental disclosure of non-cash transactions: | ||
Fixed asset acquisition included in accounts payable and accrued expenses at end of year | 293,051 | 415,650 |
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 | |
Asset retirement obligation in connection with a lease | (29,804) | (75,011) |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 34,546 | 20,894 |
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 | (4,115,843) | |
Supplemental disclosure of non-cash transactions: | ||
Issuance costs in connection with sale of ordinary shares in accounts payable and accrued expenses at end of period | 441,779 | |
Convertible Preferred C Shares [Member] | ||
Cash flows from financing activities: | ||
Issuance costs in connection with shares | $ (690,475) | |
Supplemental disclosure of non-cash transactions: | ||
Conversion of note payable into convertible preferred C shares | $ 2,500,000 |
Principal Business Activity
Principal Business Activity | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Principal Business Activity | 1. Principal Business Activity: The Company MeiraGTx Holdings plc (the “Company” or “Meira Holdings”), 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”) and Parkinson’s disease (“PD”). Reorganization and Initial Public Offering We commenced operations as MeiraGTx Limited, a private limited company incorporated under the laws of England and Wales in 2015. 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 initial public offering (“IPO”), selling 5,000,000 ordinary shares (“Ordinary Shares”) at a public offering price of $15.00 per share, and receiving $65.2 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 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”). Liquidity The Company 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. The Company’s accumulated deficit at December 31, 2018 totaled $(148,289,717), and management expects to incur substantial 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 December 31, 2018, the Company had cash and cash equivalents in the amount of $68,080,175, which consisted of depository accounts. On January 30, 2019, the Company entered into a collaboration, option and license agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceuticals Companies of Johnson & Johnson (the “Collaboration Agreement”). Under the terms of the Collaboration Agreement, the Company will receive an upfront payment of $100 million. The Company will also receive research funding for certain research, manufacturing, clinical development and commercialization costs, potential additional milestone payments upon the achievement of such milestones and royalties on future net sales of products. On February 27, 2019, the Company issued 5,797,102 ordinary shares in an $80 million private placement led by JJDC, Inc., the investment arm of Johnson & Johnson, (the “Private Placement”) for net proceeds of $77.4 million. The Company estimates that its cash and cash equivalents on hand at December 31, 2018 as well as proceeds from the Collaboration Agreement and the Private Placement will be sufficient to cover its expenses for at least the next twelve months from the date of issuance of these financial statements. 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 | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies: Consolidation The accompanying 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 Neurosciences, Inc. a Delaware corporation (“Meira Neuro”); MeiraGTx UK II Limited, (“Meira UK II”), a limited company under the laws of England and Wales; and 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 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 (“A Ordinary Shares”) issued prior to the Company’s initial public offering, the accounting for research and development costs, warrants, share-based compensation and accrued expenses. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The Company evaluated all events and transactions through March 26, 2019, the date these consolidated financial statements were issued. See Note 18 for additional information. Cash and Cash Equivalents The Company considers all highly liquid instruments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits that are readily convertible into cash. Warrant Liability During 2017, the Company issued warrants to purchase Convertible Preferred C Shares (the “Preferred Shares”) to certain investors. Due to the potential redemption feature of the underlying Preferred Shares, the warrants had been classified as a liability. Liability accounting requires that the fair value of warrants be remeasured each reporting period with changes recorded in the statements of operations and comprehensive loss. These Preferred Shares warrants remained outstanding until their exercise in June 2018, at which time the warrant liability was remeasured to fair value and reclassified to additional paid-in capital. Financial Instruments The carrying value of prepaid expenses, other current assets, accounts payable, accrued expenses, notes payable and amounts due to an affiliate reported in the consolidated balance sheets equal or approximate fair value due to their short maturities. 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 risk including our own credit risk. 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 Company’s financial assets and liabilities that are required to be measured at fair value on a recurring basis: Fair Value Measurement Using: Description December 31, 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, 2016 to December 31, 2018: Significant Significant Other Significant Balance as of December 31, 2016 $ 444,844 $ — $ — Cash released from restriction (321,468 ) — — Fair value of warrants issued — — 2,214,000 Change in fair value of warrants — — 465,633 Balance as of December 31, 2017 123,376 — 2,679,633 Change in fair value of warrants 1,514,775 Exercise of warrants — — (4,194,408 ) Balance as of December 31, 2018 $ 123,376 $ — $ — 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 $1,514,775 for the year ended December 31, 2018. The related warrant liability of $4,194,408 was reclassified as Capital in Excess of Nominal Value at such time. The fair values of the warrants were estimated using the Black-Scholes valuation model with the following assumptions: June 4, 2018 December 31, 2017 September 21, 2017 Risk-free interest rate 1.77 % 1.72 % 1.38 % Expected volatility 80 % 80 % 80 % Expected dividend yield 0 0 0 Expected life 1 day 9 months 18 months 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, as described in Note 12. The fair value of the Preferred Shares were based upon recent issuances of the Company’s Preferred Shares on or about those dates. The estimated fair values of the Company’s warrants were not necessarily indicative of the amounts that would have been realized in a current market exchange. The determination of the fair value of the warrants were sensitive to changes 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. Convertible Preferred C Shares The Preferred Shares were not redeemable, except in the event of a change of control which was outside the control of the Company and required shareholder approval. The redemption value of the Preferred Shares upon a change in control is equal to its liquidation value described below. The Company is accounting for its Preferred Shares under the requirements of ASC 480, Distinguishing Liabilities from Equity, Concentrations of Credit Risk The Company maintains its cash and cash equivalents primarily in depository and money market accounts within two large financial institutions in the United States and one large financial institution in the United Kingdom. Cash balances deposited at these major financial banking institutions exceed the insured limit. The Company has not experienced any losses on its bank deposits and believes these deposits do not expose the Company to any significant credit risk. Property, Plant and Equipment, Net Property, plant and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are depreciated over the lesser of their useful lives or the life of the lease (see Note 5). The estimated useful lives of the asset categories are set forth in the table below: Asset Category Useful Lives Computer and office equipment 3 years Laboratory equipment 5 years Manufacturing equipment 7 years Furniture and fixtures 5 years Capitalized leasehold interest 25 years Leasehold improvements lesser of useful Expenditures for leasehold improvements are capitalized, and expenditures for maintenance and repairs are expensed to operations as incurred. ASC Topic 360, Property, Plant and Equipment Net Loss per Ordinary Share Basic net loss per Ordinary Share is computed by dividing net loss 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 method, whichever is more dilutive. For all periods presented, basic and diluted net loss per Ordinary Share are the same, as any additional Ordinary Share equivalents would be anti-dilutive (see Note 13). Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2018 and 2017, the Company does not have any significant uncertain tax positions. The Company is required to estimate income taxes in each of the jurisdictions in which it operates. The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized. As of December 31, 2018, the Company had no unrecognized tax benefits or related interest and penalties accrued. In the United States, on December 22, 2017, the “Tax Cuts and Jobs Act” (the “Act”) was signed into law. Substantially all of the provisions of the Act are effective for taxable years beginning after December 31, 2017. The Act includes significant changes to the Internal Revenue Code of 1986 (as amended, the “Code”), including amendments which significantly change the taxation of individuals, and business entities. The Act contains numerous provisions impacting the Company, the most significant of which reduces the Federal corporate statutory tax rate from 34% to 21%. The staff of the U.S. Securities and Exchange Commission (“SEC”) has recognized the complexity of reflecting the impacts of the Act, and on December 22, 2017 issued guidance in Staff Accounting Bulletin 118 (“SAB 118”), which clarifies accounting for income taxes under ASC 740 if information is not yet available or complete and provides for up to a one year period in which to complete the required analyses and accounting (the measurement period). SAB 118 describes three scenarios (or “buckets”) associated with a company’s status of accounting for income tax reform: (1) a company is complete with its accounting for certain effects of tax reform, (2) a company is able to determine a reasonable estimate for certain effects of tax reform and records that estimate as a provisional amount, or (3) a company is not able to determine a reasonable estimate and therefore continues to apply ASC 740, based on the provisions of the tax laws that were in effect immediately prior to the Act being enacted. The various provisions under the Act deemed most relevant to the Company have been considered in preparation of its financial statements as of December 31, 2017. The Company had made a reasonable estimate for certain effects of tax reform and had recorded provisional amounts as part of its income tax provision. To the extent that clarifications or interpretations materialized in the future that would impact upon the effects of the Act incorporated into the December 31, 2017 financial statements, those effects would have been reflected in the future as or if they materialize. As of December 31, 2018, the Company has completed its accounting for all of the tax effects of the Act. Based on the additional analysis performed, no adjustments to the provisional amounts were made in the reporting period which had an impact to the tax provision or consolidated financial statements. 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; facilities; supplies; rent, insurance, certain legal fees, share-based compensation, depreciation, other costs associated with clinical and preclinical activities and regulatory operations and acquisition of in-process research and development write-offs. Refundable research and development credits / tax credits received are recorded as an offset to these costs. 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 consolidated financial statements as prepaid or accrued research and development expense, as the case may be. Share-Based Compensation Expense Options The Company grants share options to employees, non-employee members of the Company’s board of directors and non-employee consultants as compensation for services performed. Employee and non-employee members of the board of directors’ awards of share-based compensation are accounted for in accordance with ASC 718, Compensation Stock Compensation, . Using this model, fair value is calculated based on assumptions with respect to (i) the fair value of the Company’s Ordinary Shares on the grant date; (ii) expected volatility of the Company’s Ordinary Share price, (iii) the periods of time over which employees and members of the Company’s board of directors are expected to hold their options prior to exercise (expected term), (iv) expected dividend yield on the Company’s Ordinary Shares, and (v) risk-free interest rates. As there had been no public market for the Company’s Ordinary Shares until the Company’s IPO on June 7, 2018, the estimated fair value of the Ordinary Shares until that time had been determined by the Company’s board of directors as of the date of each option grant, with input from management, considering the most recently available third-party valuations of Ordinary Shares and the board of directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. The fair value of Ordinary Shares after the Company’s IPO was determined based upon the closing share price on the date of grant. The third party estimated the fair value of the equity using a special case of the market approach known as the backsolve method. The backsolve method was used to solve for the implied total equity value based on the Company’s recent Series C financing round. Consideration was given to the rights and preferences of each of the Company’s classes of equity and the expected time to a liquidity event. An option pricing allocation method, or OPM, was selected to allocate the total equity value. The OPM treats ordinary shares and preferred shares as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the Ordinary Shares have value only if the funds available for distribution to shareholders exceeded the value of the Preferred Shares’ liquidation preference at the time of the liquidity event, such as a strategic sale or a merger. These third-party valuations resulted in a valuation of the Company’s Ordinary Shares of $7.57, $2.64 and $5.63 per share as of December 31, 2016, September 15, 2017 and December 31, 2017, respectively. The assumptions underlying these valuations represented management’s best estimate, which involved inherent uncertainties and the application of management’s judgment. As a result, if the Company had used different assumptions or estimates, the fair value of its Ordinary Shares and its share-based compensation expense could have been materially different. Since the Company’s Ordinary Shares had not been traded on a public exchange prior to the Company’s IPO and have only been traded on a public exchange for a short period of time since the Company’s IPO, the Company believes that it does not have sufficient company-specific information available to determine the expected term based on its historical data. As a result, the expected term of share options granted to employees and members of the Company’s board of directors is determined using the average of the vesting period and contractual life of the option, an accepted method for the Company’s option grants under the SEC’s Staff Accounting Bulletin No. 107 and No. 110, Share-Based Payment. Similarly, the Company believes that its future volatility will differ materially during the expected term from the volatility that would be calculated from its historical share prices to date. Consequently, expected volatility is based on an analysis of guideline companies in accordance with ASC 718. The expected dividend yield is zero as the Company has never paid dividends and does not currently anticipate paying any in the foreseeable future. Risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the option’s expected term. The Company accounted for options granted to non-employee consultants under ASC 505-50, Equity-Based Payments to Non-Employees, . On July 1, 2018, the Company early adopted ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting all Restricted Shares In connection with certain service agreements and research agreements, the Company has granted restricted Ordinary Shares as compensation. The Ordinary Shares are recognized in the consolidated statements of operations and comprehensive loss based on their grant date fair values. Compensation cost relating to share grants with service-based graded vesting schedules is recognized based on the vesting schedule. Leases The Company recognizes rent expense for operating leases on a straight-line basis over the term of the lease, beginning on the date the Company takes possession of the property. Rent expense includes the base amounts stated in the lease agreement as well as the effect of reduced or free rent and rent escalations. At lease inception, the Company determines the lease term by assuming the exercise of those renewal options that are reasonably assured because of the significant economic penalty that exists for not exercising those options. The expected lease term is one of the factors used to determine whether a lease is classified as an operating or capital lease and is used to calculate the straight-line rent expense. The difference between the cash paid to the landlord and the amount recognized as rent expense on a straight-line basis is included in deferred rent and classified within long-term liabilities. Lease incentives made by landlords to or on behalf of the Company for leasehold improvements are recorded as deferred rent and classified as long-term liabilities. 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 on our Consolidated Balance Sheets 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 folows: For the year ended 2018 2017 Balance at beginning of year $ 178,419 $ 221,254 Inception of asset retirement obligation 69,286 — Amortization of interest (38,301 ) 19,313 Change in estimate (99,090 ) (75,011 ) Effects of exchange rate 17,805 12,863 Balance at end of year $ 128,119 $ 178,419 Other Comprehensive Income (Loss) Other comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. The only component of other comprehensive income (loss) impacting the Company is foreign currency translation. Foreign Currencies The Company’s consolidated financial statements are presented in U.S. dollars, the reporting currency of the Company. The financial position and results of operations of Meira UK II and Meira B.V. are measured using the foreign subsidiaries’ local currency as the functional currency. Meira UK II’s cash accounts holding U.S. dollars are remeasured based upon the exchange rate at the date of remeasurement with the resulting gain or loss included in the consolidated statements of operations and comprehensive loss. Expenses of such subsidiaries have been translated into U.S. dollars at average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the consolidated balance sheets dates. The resulting translation gain and loss adjustments are recorded directly as a separate component of shareholders’ equity and as other comprehensive loss on the consolidated statements of operations and comprehensive loss. 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 assets by geographical area: December 31, December 31, United States $ 454,568 $ 436,463 United Kingdom 21,788,130 13,942,642 $ 22,242,698 $ 14,379,105 Accounting Pronouncements Recently Adopted In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, all In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business, , In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, In November 2016, the Financial Accounting Standards Board, or FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash In May 2016, the FASB issued ASU No. 2016-12 , Revenue from Contracts with Customers (Topic 606), Narrow-Scope Improvements and Practical Expedients Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date . Revenue from Contracts with Customers (Topic 606), Identifying Performance Obligations and Licensing , Revenue from Contracts with Customers (Topic 606), Principal versus Agent Considerations (Reporting Revenue Gross versus Net) In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. Technical Corrections and Improvements to Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, Recent Accounting Pronouncements Not Yet Adopted In November 2018, the FASB issued Accounting Standards Update No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”). The standard amends Accounting Standards Codification 808, Collaborative Agreements and Accounting Standards Codification 606, Revenue from Contracts with Customers, to clarify the interaction between collaborative arrangement participants that should be accounted for as revenue under ASC 606. In transactions when the collaborative arrangement participant is a customer in the context of a unit of account, revenue should be accounted for using the guidance in Topic 606. The amendments in Update No. 2018-18 are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The Company is currently evaluating the new guidance included in ASU 2018-18, but does not expect it to have a material impact on its consolidated financial statements. In October 2016, the FASB issued ASU 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other than Inventory In February 2016, the FASB issued ASU No. 2016-02, “Leases” (ASC 842). The amended guidance requires lessees to recognize lease liabilities and right-of-use assets on the balance sheet for all leases with terms longer than 12 months and provides enhanced disclosures on key information of leasing arrangements. In July 2018, further amendments were issued to clarify how to apply certain aspects of the amended lease guidance and to address certain implementation issues. The amended guidance is effective for us commencing in the first quarter of 2019. Early adoption is permitted. We plan to adopt the amended guidance on the effective date and expect to elect the package of practical expedients. We expect the adoption of the amended guidance will materially affect our consolidated balance sheet and that the primary impact will be recognition of minimum commitments at present value of our noncancelable operating leases as lease liabilities and corresponding right-of-use assets. In July 2018, the FASB issued ASU No. 2018-10, which provides narrow amendments to ASU No. 2016-02 to clarify how to apply the rate implicit in the lease, impairment of the net investment in the lease, lessee reassessment of lease classification, variable payments that depend on an index or rate and certain transition adjustments. In July 2018, the FASB also issued ASU No. 2018-11, which provides targeted improvements to ASU No. 2016-02 to provide entities the transition option to not apply the standard in the comparative periods presented in the year of adoption. The Company will adopt the new standard effective January 1, 2019 using the modified retrospective transition method using the practical expedients model and a discount rate in the range of 8% to 10%, and elect to not apply the standard in the comparative periods presented in the year of adoption. We estimate that upon implementation, we will record a right-of-use asset between $3.3 million and $3.6 million and a corresponding liability between $3.6 million and $3.8 million. We are continuing to evaluate the impact that the amended lease guidance will have on our consolidated financial statements, systems, processes and internal controls. |
Asset Acquisition
Asset Acquisition | 12 Months Ended |
Dec. 31, 2018 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Asset Acquisition | 3. Asset Acquisition: On October 5, 2018, the Company entered into an agreement to acquire Vector Neurosciences Inc. (“Vector”) pursuant to an Agreement and Plan of Merger (the “Merger Agreement”) by and among the Company, Vector, VN Acquisition, Inc., a wholly-owned subsidiary of the Company (“Merger Sub 1”), VN Acquisition 2, Inc., a wholly-owned subsidiary of the Company (“Merger Sub 2”), the Vector stockholders named therein and the Vector stockholder representative, pursuant to which Merger Sub 1 was merged with and into Vector, with Vector being the surviving corporation (“Merger 1”) and, immediately following Merger 1, Vector was merged with and into Merger Sub 2, with Merger Sub 2 being the surviving corporation (together with Merger 1, the “Merger”). As a result of the Merger, Vector is a wholly-owned subsidiary of the Company. The Company’s board of directors, Vector’s board of directors and Vector’s stockholders have, in each case, unanimously approved the Merger, the Merger Agreement and the transactions contemplated by the Merger Agreement. The merger consideration to Vector’s stockholders consists of 225,000 shares of the Company’s Ordinary Shares as initial merger consideration, consisting of 202,500 shares which were issued at the closing of the Merger and an additional 22,500 shares to be issued 18 months following the closing, subject to any indemnification claims under the Merger Agreement (See Note 12). In addition, pursuant to the terms of the Merger Agreement, the Company will issue to Vector’s stockholders additional Ordinary Shares equal to a maximum value of $21,000,000 if specified regulatory milestones are met and will make royalty payments to Vector’s stockholders in an amount equal to a percentage of the value of sales of certain products developed based on the Vector assets, which royalty payments are also payable in Ordinary Shares. The number of Ordinary Shares to be issued in connection with such milestones and royalties will be based on the three-day average closing price of the Company’s Ordinary Shares immediately prior to the date of determination of the value of the payment. The Company determined this transaction represented an asset acquisition as substantially all of the value was in the intellectual property as defined by ASC 805, Business Combinations |
Prepaid Expenses
Prepaid Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Other Income and Expenses [Abstract] | |
Prepaid Expenses | 4. Prepaid Expenses: Prepaid expenses at December 31, 2018 and 2017 consist of the following: December 31, December 31, Insurance $ 623,314 $ 163,284 Clinical Trial Costs 373,723 839,644 Research and Development 352,658 624,348 Other 330,233 160,595 Dues and License Fees 169,073 145,594 Rent 88,784 27,778 $ 1,937,785 $ 1,961,243 |
Property, Plant and Equipment,
Property, Plant and Equipment, net | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, net | 5. Property, Plant and Equipment, net: Property, plant and equipment, net at December 31, 2018 and 2017 consist of the following: December 31, December 31, Leasehold Improvements $ 11,538,377 $ 10,873,895 Capitalized Leasehold Interest 7,150,611 — Manufacturing Equipment 3,779,950 2,477,637 Laboratory Equipment 1,485,544 993,409 Computer and Office Equipment 334,525 276,100 Asset Retirement Obligation 113,678 153,133 Furniture & Fixtures 88,660 93,786 24,491,345 14,867,960 Less: Accumulated depreciation (2,477,108 ) (612,231 ) $ 22,014,237 $ 14,255,729 In February 2016, the Company sublet a manufacturing facility for a term of 5 years, that included an additional 5-year option. This sub-lease was accounted for as an operating lease. On December 14, 2018, the Company executed a new sub-lease for this manufacturing facility whereby the sub landlords remaining term of 108 years was assigned to the Company. Under the new sub-lease, the Company paid a one-time fee of £5,250,000 (approximately $6,615,000 assuming a rate of $1.26 per GBP on the date of the acquisition) for the assignment and will no longer pay any base rent for the remaining 108 years. The one-time fee and related transaction costs, in the aggregate amount of £5,613,165 (approximately $7,150,611 using a rate of $1.2739 per GBP at December 31, 2018), have been accounted for as a capital lease and recorded as property, plant and equipment. The Company determined that the cost of the new sub-lease would be amortized on a straight-line basis over a 25-year estimated useful life. In connection with the above-mentioned lease, the Company estimated that it had an asset retirement obligation at the end of the initial five-year lease term in the amount of $306,400. The Company discounted the asset retirement obligation using an 8% discount rate and recorded an asset retirement obligation in the amount of $205,659 as of December 31, 2016, which is included in leasehold improvements and was being depreciated over the five-year term of the lease (see Note 15). As of December 31, 2017, the Company determined that it was probable that it would exercise the additional five-year option provided for in the sub-lease. Therefore, the company remeasured the asset retirement obligation using the remaining eight-year new sub-lease term and recorded a reduction in the asset retirement obligation of $75,011 recorded in leasehold improvements. On December 14, 2018, upon execution of the new sub-lease, the Company remeasured the asset retirement obligation using the remaining 25-year estimated useful life and recorded a reduction in the asset retirement obligation of $99,090 recorded in leasehold improvements. In connection with two operating leases entered into in July 2018, the Company estimated that it had asset retirement obligations at the end of the eight-year terms in the amount of $140,129. The Company discount the asset retirement obligation using an 8% discount rate and recorded an asset retirement obligation in the aggregate amount of $69,286, which is included in leasehold improvements and is being depreciated over the eight-year term of the lease. Capitalized leases in the amount of $95,880 are included in computer and office equipment at December 31, 2018 and 2017, and accumulated depreciation of $62,912 and 34,552 at December 31, 2018 and 2017, respectively. A capitalized lease in the amount of $7,150,611 is included in capitalized leasehold interest at December 31, 2018 and accumulated depreciation of $6,928 at December 31, 2018. Depreciation expense was $2,052,948 and $679,177 for the years ended December 31, 2018 and 2017 respectively. |
Restricted Cash
Restricted Cash | 12 Months Ended |
Dec. 31, 2018 | |
Receivables [Abstract] | |
Restricted Cash | 6. Restricted Cash: The Company is required to maintain a stand-by letter of credit as a security deposit under the ARE-East River Science Park LLC (“ARE”) lease (see Note 15) through the end of the lease term in December 2021, plus three months. The fair value of the letter of credit approximates its contract value. The Company’s bank requires the Company to maintain a restricted cash balance to serve as collateral for the letter of credit issued to the landlord by the bank. As of December 31, 2018 and 2017, the restricted cash balance for the ARE lease was invested in a commercial money market account. The Company had $123,376 of restricted cash included in long-term assets as of December 31, 2018 and 2017 and is measured using level 1 inputs. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 7. Accrued Expenses: Accrued expenses at December 31, 2018 and 2017 were comprised of the following: December 31, December 31, Compensation and Benefits $ 5,731,438 $ 2,386,903 Clinical Trial Costs 4,013,094 4,859,410 Professional Fees 914,540 231,923 Consulting 821,009 1,220,477 Research and Development 236,271 73,379 Rent 122,770 387,267 Interest 40,800 33,437 Other 111,775 140,148 $ 11,991,697 $ 9,332,944 |
Capitalized Leases
Capitalized Leases | 12 Months Ended |
Dec. 31, 2018 | |
Text Block [Abstract] | |
Capitalized Leases | 8. Capitalized Leases: In 2015, the Company acquired certain office equipment in the amount of $17,817 under a 3-year lease arrangement. The Company determined that the lease should be capitalized since it contained a bargain purchase option for the equipment at the end of the lease term. Total payments under the capital lease amounted to $20,502 and had an interest rate of 9.35%. In 2017, the Company acquired additional office equipment in the amount of $78,063 under a 3-year lease arrangement. The Company determined that the lease should be capitalized since it contained a bargain purchase option for the equipment at the end of the lease term. Total payments under the capital lease will amount to $86,145 and has an interest rate of 6.90%. In December 2018, the Company entered into a sub-lease for the remaining term of 108 years (see Note 5). The Company determined that the lease should be capitalized since the lease term exceeded 75% of the estimated 25-year useful life of the leasehold interest. The Company made a one-time upfront payment for the assignment of the lease and will not have any obligation to make future rent payments. The Company capitalized as property, plant and equipment, the initial one-time upfront payment and related transaction costs in the aggregate amount of $7,150,611. The following is a schedule, by year, of future minimum lease payments under the capital leases together with the present value of the net minimum lease payments as of December 31, 2018: 2019 28,715 2020 7,179 Total minimum lease payments 35,894 Less: amount representing interest (1,598 ) Present value of net minimum lease payments 34,296 Less: current portion (27,199 ) Obligations under capital lease, less current portion $ 7,097 |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Notes Payable | 9. Notes Payable On October 26, 2017, in connection with an amendment and termination of a lease, the Company issued a promissory note in the amount of $1,442,009 to ARE, the landlord and also a related party (see Note 15). The note bears 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 amount of $1,472,433 during the three-month period ended March 31, 2018. The Company recorded interest expense in the consolidated statements of operations and comprehensive loss in connection with the note in the amount of $17,386 and $13,037 for the years ended December 31, 2018 and 2017, respectively. |
Collaboration Agreement
Collaboration Agreement | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreement | 10. Collaboration Agreement On October 16, 2018, the Company entered into a research collaboration agreement with Janssen Pharmaceuticals, Inc., (“Janssen”), to develop regulatable gene therapy treatment using the Company’s proprietary riboswitch technology. As part of the agreement, the Company will use its proprietary riboswitch technology to engineer regulatable gene therapy constructs encoding proprietary gene sequences from Janssen. Upon execution of the agreement, Janssen paid the stage 1 fee in the amount of $658,667 and such payment was recorded as deferred research funding. The stage 1 fee is being amortized over the estimated research term of eight months. During the year ended December 31, 2018, the Company amortized $224,576 of the deferred research funding, which was recorded as an offset to research and development expenses. Deferred research funding in the amount of $434,091 is included as other current liabilities on the consolidated balance sheet at December 31, 2018. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 11. Share-Based Compensation 2018 and 2016 Equity Incentive Plans The Company’s 2018 Incentive Award Plan and 2016 Equity Incentive Plan (the “Plans”), were adopted by the Company’s board of directors and shareholders. Under the Plans, the Company has granted share options to selected officers, employees and non-employee consultants. The Company’s board of directors administer the Plans. Options granted under the Plans have a maximum contractual term of ten years. Options granted generally vest 25% on the first anniversary date of grant and the balance ratably over the next 36 months. Options granted to directors generally vest on the first anniversary date of grant. Upon the adoption of the 2018 Incentive Award Plan, the Company ceased issuing awards under the 2016 Equity Incentive Plan. A summary of the Company’s share option activity related to employees, non-employee members of the board of directors and non-employee consultants as of and for the years ended December 31, 2018 and 2017 is as follows: STOCK OPTION TABLE Number of Weighted- Aggregate Outstanding at December 31, 2016 333,660 $ 7.72 Granted 611,933 3.73 Exercised (1,288 ) (7.57 ) Expired — — Forfeited (5,668 ) (7.72 ) Outstanding at December 31, 2017 938,637 $ 5.12 Granted 2,334,285 8.63 Exercised — — Expired — — Forfeited (10,557 ) (5.51 ) Outstanding at December 31, 2018 3,262,365 $ 7.64 $ 6,903,313 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 December 31, 2018 (yrs) 9.24 Options exercisable at December 31, 2017 186,394 $ 7.72 Options exercisable at December 31, 2018 535,241 $ 5.79 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 December 31, 2018 (yrs) 7.88 The total fair value of options vested during the years ended December 31, 2018 and 2017 was $1,387,607 and $898,699, respectively. During the years ended December 31, 2018 and 2017, the Company granted 2,334,285 and 611,933 share options, respectively. The grant date fair values of the stock options granted were estimated using the Black-Scholes option valuation model with the following ranges of assumptions (see Note 2): 2018 2017 Risk-free interest rate 2.32% - 2.98% 2.28% - 2.51% Expected volatility 90% 80% Expected dividend yield 0% 0% Expected life (in years) 5.5 - 10.0 5.5 - 10.0 As of December 31, 2018 and 2017, the total compensation expense relating to unvested options granted that had not yet been recognized was $17,415,098 and $987,413, respectively which is expected to be realized over a period of 4.0 and 3.42 years, respectively. The Company will issue shares upon exercise of options from Ordinary Shares reserved. The weighted average grant date fair value of options granted during the years ended December 31, 2018 and 2017 was $6.53 and $3.10, respectively. 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 December 31, 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 of such shares vested immediately, with the balance vesting quarterly over the next eight quarters beginning three months after the effectiveness of the Company’s registration statement on Form S-1 filed with the SEC on June 7, 2018 (the “Registration Statement”). The shares were valued at $15.00 per share and the related share-based compensation expense, which is recognized over the requisite service period, is included in general and administrative expenses in the consolidated statements of operations and comprehensive loss. 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 restricted shares. Total compensation expense in connection with the issuance of those restricted Ordinary Shares, in the amount of $20,141,876, of which $10,156,868 was share-based, was recorded as general and administrative expense during the year ended December 31, 2018 (See Note 16). A summary of the restricted Ordinary Shares is as follows: Ordinary Shares $ Value Non-vested at December 31, 2016 386,608 $ 3,020,191 Vesting during 2017 (280,695 ) (2,154,330 ) Non-vested at December 31, 2017 105,913 865,861 Issued during 2018 1,306,348 19,595,220 Vesting during 2018 (759,087 ) (10,663,471 ) Non-vested at December 31, 2018 653,174 $ 9,797,610 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 $3,096,104 was share-based, was recorded as general and administrative expense during the year ended December 31, 2018. During the years ended December 31, 2018 and 2017 the Company recognized total share-based compensation expense in the accompanying consolidated statements of operations and comprehensive loss as follows: 2018 2017 Research and development $ 3,372,054 $ 2,374,899 General and administrative 14,511,500 584,832 Total share based compensation $ 17,883,554 $ 2,959,731 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 years ended December 31, 2018 and 2017. |
Ordinary Shares, Convertible Pr
Ordinary Shares, Convertible Preferred C Shares and Shareholders' Deficit | 12 Months Ended |
Dec. 31, 2018 | |
Federal Home Loan Banks [Abstract] | |
Ordinary Shares, Convertible Preferred C Shares and Shareholders' Deficit | 12. Ordinary Shares, Convertible Preferred C Shares and Shareholders’ Deficit: Ordinary Share Issuances 2018 As discussed in Note 11, 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 $9,807,622. Also, as discussed in Note 11, 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 of such shares vested immediately, with the balance vesting quarterly over the next eight quarters. On October 5, 2018, in connection with an acquisition, the Company issued 202,500 Ordinary Shares with an additional 22,500 shares to be issued 18 months following the closing, subject to any indemnification claims under the merger agreement. 2017 On July 31, 2017, the Company issued 1,288 Ordinary Shares in connection with the exercise of an option. On August 16, 2017, the Company issued 6,441 Ordinary Shares in connection with a research agreement. Convertible Preferred C Shares Issuances 2018 During the year ended December 31, 2018, the Company issued 5,425,124 Preferred Shares at an offering price of approximately $10.48 per share for gross proceeds of $56,849,611, excluding offering costs of $690,473. Also, during the year ended December 31, 2018, the Company issued 129,419 Preferred Shares in lieu of payment of accounts payable in the aggregate amount $1,355,097 to certain vendors. 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, all of the 11,501,432 outstanding Preferred Shares were automatically converted into 11,501,432 Ordinary Shares. In connection with the conversion of the Preferred Shares, $664,718 of unaccredited financing costs were fully accreted. 2017 During the year ended December 31, 2017, the Company issued 9,739 Preferred Shares at an offering price of $20.96 per share and 1,598,418 Preferred Shares at an offering price of $10.48 per share for gross proceeds of $16,854,656, excluding offering costs of $98,804. The net proceeds of the offering were used for working capital, research and development and general corporate purposes. On November 2, 2017, a note payable to a related party in the amount of $2,500,000 was converted at the rate of $10.48 per share, into 238,579 Preferred Shares (see Note 15). Warrants In connection with the issuance of 715,737 Preferred Shares on September 21, 2017, at an offering price of $10.48 per share, the Company issued warrants to purchase 695,696 Preferred Shares at an exercise price of $10.48 per share. The warrants expired on the first of the following to occur: (i) an Asset Sale; (ii) a Qualified IPO; (iii) a Share Sale; (iv) the winding up of the Company; or (v) On the third anniversary of the date of issuance The Black-Sholes value of the warrants in the amount of $1,660,500 was accounted for as a warrant liability and a discount to the Preferred Shares at the time of issuance and were being accreted over the expected term of the Preferred Shares (see Note 2). The Black-Scholes value of the warrants in the amount of $553,500 was recorded as a warrant liability and charged to convertible note inducement expense within the statement operations and comprehensive loss at the time of issuance. Both of the warrants were revalued under the Black-Scholes valuation model at December 31, 2017, which resulted in an increase of the warrant liability in the amount of $465,633, which was charged to change in fair value of warrant liability within the statement of operations and comprehensive loss. The warrant liability at December 31, 2017 was $2,679,633. 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. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 13. 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: 2018 2017 Net loss—basic and diluted $ (82,865,874 ) $ (31,044,535 ) Accretion of Preferred Shares financing costs (1,806,512 ) (191,963 ) Accretion of warrant — (615,000 ) Adjusted net loss—basic and diluted $ (84,672,386 ) $ (31,851,498 ) Weighted-average ordinary shares outstanding: Basic and Diluted 18,948,520 8,572,315 Net loss per share: Basic and Diluted $ (4.47 ) $ (3.72 ) 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: December 31, December 31, Preferred Shares — 5,005,934 Restricted Ordinary Shares subject to forfeiture 653,174 105,913 Stock options 3,262,365 938,637 Warrants — 927,594 3,915,539 6,978,078 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes: Since the Company has recurring losses and a valuation allowance against deferred tax assets, there is no tax expense (benefit) for the year ended 2017. For the year ended December 31, 2018, the Company recognized a tax benefit of $(474,391). The subsidiaries each file separate tax returns in their respective tax jurisdictions. As of December 31, 2018, the Company had federal and state net operating loss (“NOL”) carryforwards in the United States of approximately $14,210,000 and $14,155,000, respectively, and in the United Kingdom of approximately $94,100,000, which are available to reduce future taxable income. The U.S. federal and state NOL carry forwards incurred prior to January 1, 2018 in the amount of approximately $6.8 million and $6.7 million, respectively, will begin to expire in 2036. The U.S. NOL incurred after December 31, 2018 and the U.K. NOL will be indefinitely carried forward. Also, as of December 31, 2018, the Company had orphan drug and research and development credits in the U.S. in the amount of $1,134,000 which will begin to expire in 2036. The NOL carry forwards are subject to review and possible adjustment by the U.S., U.K. and state tax authorities. NOL carry forwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders, as defined under Sections 382 Internal Revenue Code, as well as CTA 2010 Part 14 under the UK tax rules. This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. As of December 31, 2018, the Company has performed such an analysis and determined that there were no limitations in the U.K. However, for U.S. purposes the Company determined that a change of ownership occurred in April 2016. The Company is still in the process of determining the annual limitation on losses that occurred prior to April 2016. Subsequent ownership changes and proposed future changes to the UK (or US) tax rules in respect of the utilization of losses carried forward may further affect the limitation in future years, if any. Additionally, the Company has not undertaken a study on the completeness of the U.S. orphan drug and research and development credit. The Company’s pre tax earnings from the United Kingdom and United States locations are as follows: December 31, December 31, United Kingdom $ (73,359,977 ) $ (26,458,625 ) United States (9,980,287 ) (4,585,910 ) $ (83,340,264 ) $ (31,044,535 ) The Company is subject to the corporate tax rate in the U.K. as a Limited U.K. corporation. The following table summarizes a reconciliation of income tax benefit compared with the amounts at the U.K. statutory income tax rate: December 31, December 31, Statutory rate (15,834,650 ) 19.00 % (5,976,073 ) 19.25 % Permanent differences—other 1,438,934 -1.73 % 654,648 -2.11 % RTP and other adjustments 387,509 -0.46 % (152,948 ) 0.49 % U.K. tax credit 1,707,489 -2.05 % 539,136 -1.74 % U.S. tax credit (436,250 ) 0.52 % (363,665 ) 1.17 % Foreign tax rate differential (171,693 ) 0.21 % (673,619 ) 2.17 % State and local rate, net of federal tax (1,159,522 ) 1.39 % (446,683 ) 1.44 % UK Rate Change (17% at expected DTA turn) 1,104,863 -1.33 % 482,351 -1.55 % U.S. state rate change (6,496 ) 0.01 % 993,998 -3.20 % Change in valuation allowance 12,495,426 -14.99 % 4,942,855 -15.92 % Actual income tax benefit effective tax rate (474,391 ) 0.57 % — 0.00 % The Expense/(Benefit) for income taxes from continuing operations consists of the following: December 31, December 31, Current Tax Expense/(Benefit) United Kingdom — — United States — — Total Current — — Deferred Tax Expense/(Benefit) United Kingdom $ (8,888,096 ) $ (3,759,109 ) United States (3,606,275 ) (1,183,746 ) Total Deferred (12,494,371 ) (4,942,855 ) Change in Valuation Allowance 12,019,880 4,942,855 Total Income Tax Expense/(Benefit) $ (474,391 ) $ — Income tax (benefit) expense for each year is allocated to continuing operations, discontinued operations, extraordinary items, other comprehensive income, the cumulative effects of accounting changes, and other charges or credits recorded directly to shareholders’ equity. ASC 740-20-45 Income Taxes, Intraperiod Tax Allocation, Other Presentation Matters As the Company experienced a net loss from operations for the year ended December 31, 2018 and other comprehensive income from foreign currency translation adjustments, the Company has allocated income tax expense against the components of other comprehensive income in 2018 using a 17% effective tax rate. Income tax benefit for the year ended December 31, 2018 includes a benefit of $(474,391) due to the required intraperiod tax allocation. Conversely, other comprehensive income for the year ended December 31, 2018 includes income tax expense of $474,391. Deferred Tax Assets/(Liabilities) December 31, 2018 Total UK US Deferred Tax Assets: Net operating loss carryforwards $ 20,646,185 $ 16,000,329 $ 4,645,856 Other 1,414,690 (46,604 ) 1,461,294 Tax Credit 1,133,656 — 1,133,656 Deferred tax assets 23,194,531 15,953,725 7,240,806 Less: valuation allowance (23,194,531 ) (15,953,725 ) (7,240,806 ) Net deferred tax asset $ — $ — $ — December 31, 2017 Total UK US Deferred Tax Assets: Net operating loss carryforwards $ 9,462,690 $ 6,909,754 $ 2,552,937 Other 539,008 152,554 386,454 Tax Credit 697,406 — 697,406 Deferred tax assets 10,699,105 7,062,308 3,636,797 Less: valuation allowance (10,699,105 ) (7,062,308 ) (3,636,797 ) Net deferred tax asset $ — $ — $ — ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against its deferred tax assets at December 31, 2018 and 2017 because the Company’s management has determined that is it more likely than not that these assets will not be fully realized. Changes to the U.K. and U.S. corporation tax rates have been announced which will impact future accounting periods. In his budget of July 8, 2015, the Chancellor of the Exchequer announced a reduction in the U.K. corporation tax rate to 19% for the financial year beginning April 1, 2017 and a further reduction to 18% for the financial year beginning April 1, 2020. These changes received Royal Assent on November 18, 2015. The U.K. Finance Act 2016 provides for a further reduction in the corporation tax rate to 17% for the Financial Year beginning April 1, 2020. This change was enacted on September 15, 2016. As the Company does not expect to be able to utilize its NOL’s in the U.K. prior to its financial year beginning on January 1, 2021, if at all, the deferred tax has been calculated using a tax rate of 17%. In the United States, the corporation tax rate was reduced to 21% for the financial year beginning January 1, 2018. As these changes were enacted prior to the December 31, 2017 balance sheet date, deferred tax has been calculated accordingly in these consolidated financial statements, which represented a decrease in the prior years deferred tax assets of approximately $994,000. The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2018 and 2017, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations and comprehensive loss. The Company files income tax returns in the United States, United Kingdom and the Netherlands, and various state jurisdictions. For the US, the statute of examination is open for tax years 2015, 2016, 2017 and 2018. For the UK and the Netherlands, the statute of examination is open for tax years 2017 and 2018. MeiraGTx Holdings plc is a UK tax resident with no earnings in its foreign subsidiaries and the Company does not expect any temporary basis difference in its investment in these subsidiaries to reverse in the foreseeable future. Therefore, the Company has not recorded deferred taxes on the outside basis difference in its foreign subsidiaries. It is not probable to compute the amounts, if any. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 15. Related Party Transactions: Transition Services Agreement Effective April 24, 2015, the Company entered into a transition services agreement (the “TSA”) with Kadmon, which owned 12.9% of the Company at December 31, 2018, whereby Kadmon would provide office and laboratory facilities as well as certain other personnel support activities to the Company. Under the agreement, the Company is 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 years ended December 31, 2018 and 2017, the Company incurred the following charges in connection with the TSA which are included in loss from operations: 2018 2017 Rent $ 557,698 $ 548,229 Personnel 6,493 39,721 Other 6,334 5,983 Total charges incurred $ 570,525 $ 593,933 During the year ended December 31, 2018 and 2017, the Company made cash payments totaling $1,431,555 and $275,941, respectively. The amount due to Kadmon at December 31, 2018 and 2017 is $0 and $861,030, respectively, and is disclosed as Due to Kadmon on the Company’s 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 research and development under the direction of the Company. In connection with the agreement, the Company issued several work orders during the years ended December 31, 2016 and 2017 in the aggregate amounts of £1,402,202, or approximately $1,885,000, based upon the average exchange rates during the years ended December 31, 2016 and 2017, respectively. Either party may terminate the agreement by giving 30 days written notice. Total research and development expenses under this agreement for the years ended December 31, 2018 and 2017 was approximately $636,000 and $538,000, respectively. Future obligations under the agreement equal £612,382, or approximately $779,685, through October 2020. The amount due to UCL under the master services agreement at December 31, 2018 and 2017 is $389,101 and $775,315, respectively and is included in accounts payable and accrued expenses on the Company’s consolidated balance sheets. 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. The agreement was terminated in January 2018. Total research and development expenses under this agreement for the years ended December 31, 2018 and 2017 was approximately $0 and $1,904,352, respectively. The amount due to UCL under the manufacturing and drug supply agreement at December 31, 2018 and 2017 is $0 and $2,466,142, respectively and is included in accrued expenses on the balance sheet. Leases July 2016 Lease Effective July 1, 2016, the Company entered into a non-cancellable operating lease for laboratory and related office facilities in New York with ARE, an entity that is under common control by an entity that is a minority shareholder of the Company and whose executive chairman and founder is a director of the Company. The lease provides for monthly base rent and property management fees, including rent escalations and rent holidays, plus operating expenses during the lease term, which expires on December 31, 2021. The Company records monthly rent expense on a straight-line basis from July 1, 2016 through December 31, 2021. As of December 31, 2018 and 2017, the balance of deferred rent, representing the difference between cash rent paid and straight-line rent expense, was $201,264 and $231,276, respectively. Total rent expense under this operating lease was $487,555 and $487,559 for the years ended December 31, 2018 and 2017, respectively. As of December 31, 2018, the aggregate future minimum rental payments under this lease are $1,663,952. 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 expired on July 7, 2017 and was automatically renewed annually through July 7, 2021. This standby letter of credit is secured with restricted cash in a money market account (see Note 6). December 2016 Lease Effective December 15, 2016, the Company entered into another non-cancellable operating lease with ARE, expiring on October 31, 2032, for laboratory and office facilities in New York. The lease provided for monthly base rent, including rent escalations, property management fees and rent holidays, plus operating expenses during the lease term. The Company recorded monthly rent expense on a straight-line basis from December 15, 2016 through October 31, 2032. On October 26, 2017, the lease was amended, whereby the lease would terminate on March 31, 2018 and only base rent and management fees in the aggregate amount of $563,507 would be due from November 1, 2017 through March 31, 2018. Under the amendment, the Company issued a note to ARE in the amount of $1,442,009 (see Note 9), removed the balance of the deferred rent and accrued the future rent payments, all of which were recorded as rent expense at the time of the amendment, in accordance with ASC 420, Exit and Disposal Activities, as the Company had a cease use date as of the date of the amendment. Total rent expense under this operating lease was $0 and $1,660,806 for the years ended December 31, 2018 and 2017, respectively. Convertible Note Payable On May 1, 2017, the Company issued a convertible note in the amount of $2,500,000 to ARE. The note had an interest rate of 10% per annum and was convertible into Preferred Shares at any time at the option of the holder or would automatically convert into Preferred Shares in the event of an equity investment by a mutually agreed upon institutional investor at a price per share equal to the lowest price paid per share by a purchaser of the Company’s Preferred Shares. On November 2, 2017 the note was converted to 238,579 Preferred Shares at $2.70 per share. In accordance with the terms of the convertible note, the accrued interest in the amount of $145,833 was cancelled. As an inducement to convert the convertible note, the Company issued a warrant to purchase 900,000 Preferred Shares, at an exercise price of $2.70 per share, to the holder of the convertible note, which was expenses in accordance with ASC 470 (see Note 12). |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 16. Commitments: Operating Leases In February 2016, the Company entered into a non-cancellable operating lease, expiring in February 2021, for manufacturing and office facilities in London, UK. The lease provides for an additional five-year term at the Company’s option. The lease provides for monthly base rent, plus operating expenses and real estate taxes during the lease term. Total rent expense under this operating lease was $273,430 and $279,303 for the years ended December 31, 2018 and 2017, respectively. On October 1, 2017, the Company entered into a one-year non-cancellable operating lease, expiring in September 2018, for office and laboratory facilities in Leiden, Netherlands. The lease provides for monthly base rent plus operating expenses during the lease term. The lease provides for successive one-year extensions up to a maximum of four extensions. Total rent expense under this operating lease was $9,313 and $5,273 for the years ended December 31, 2018 and 2017, respectively. In June 2017, the Company entered into two non-cancellable operating leases, expiring in July 2018, for office and laboratory facilities in London, UK. The lease provides for monthly base rent, rent holidays plus operating expenses and real estate taxes during the lease term. The Company records monthly rent expense on a straight-line basis from June 1, 2017 through July 23, 2018. As of December 31, 2018, the balance of deferred lease obligation, representing the difference between cash rent paid and straight-line rent expense, was $0. Total rent expense under theses operating leases was $73,846 and $85,222 for the years ended December 31, 2018 and 2017, respectively. On July 27, 2018 the two leases for office and laboratory facilities in London, UK expired. Effective July 27, 2018, the Company entered into two new non-cancellable operating leases for the same office and laboratory facilities in London. The leases provide for annual base rent in the aggregate amount of approximately $363,000, plus operating expenses, through May 31, 2022, at which time the annual base rent will be revalued based on market rates at that time. The leases expire on May 24, 2027. Total rent expense under these operating leases was $148,561 and $0 for the years ended December 31, 2018 and 2017, respectively. The aggregate future minimum rental payments under these operating leases are as follows: 2019 $ 353,782 2020 $ 350,284 2021 $ 350,284 2022 $ 350,284 2023 $ 350,284 Thereafter $ 1,196,805 Total future rent payments $ 2,951,723 The aggregate future minimum rental payments of all leases, including those discussed in Note 15 are as follows: 2019 $ 889,465 2020 $ 904,716 2021 $ 924,121 2022 $ 350,284 2023 $ 350,284 Thereafter $ 1,196,805 Total future rent payments $ 4,615,675 Service Agreements On April 27, 2015, the Company entered into service agreements with a senior officer and a greater than 5% shareholder of the Company. Under the terms of the agreements, the employees will receive aggregate compensation of £300,000, which has been increased to a maximum aggregate amount of £410,000 per annum, or approximately $522,000 using exchange rates as of December 31, 2018. The agreements also provide for contributions to a defined contribution pension plan to be set up by the Company and a discretionary bonus. The agreements may be terminated at any time by either party by giving twelve-months’ notice, or the Company may terminate the officer’s employment effective immediately upon notice, and within 28 days making payment in lieu of notice consisting of a sum equivalent to the officer’s annual salary for the relevant period. For the years ended December 31, 2018 and 2017, the Company recorded £1,001,000 and £724,000 or approximately $1,334,000 and $933,000, respectively, using the average exchange rates during the years ended December 31, 2018 and 2017, respectively, in research and development costs under these agreements. Future obligations to be paid under these agreements equal £150,333, or approximately $192,000, using exchange rates as of December 31, 2018. In connection with the service agreements, on April 24, 2015, the employees were awarded, under a share award agreement (the “Share Award Agreement”), an aggregate of 2,704,800 restricted Ordinary Shares and 750 B ordinary shares, which B ordinary shares have been converted into Ordinary Shares, of the Company. Under the Share Award Agreement, such shares are subject to forfeiture ratably over a period of three years if the employee’s do not remain an employee or consultant to the Company. The shares were valued at $7.76 per share and, in accordance with ASC 718, were charged to operations as share-based compensation ratably over the forfeiture period. Employment Agreements In February 2016, the Company entered into three-year employment agreements with certain senior officers of the Company. Under the terms of the agreements, which automatically renew for successive one-year terms, the employees will receive annual compensation in the aggregate amount of $710,000, which has been increased to a maximum aggregate amount of $1,075,000. The employment agreements also provide for an annual guaranteed cash bonus targeted at 100% of annual compensation. The agreements also provide for discretionary annual performance bonuses targeted to be not less than 50-60% of the employee’s base salary and grants of restricted stock. In January 2018 the Company’s compensation committee approved a discretionary bonus in the aggregate amount of $1,196,000. This discretionary bonus and the guaranteed bonus for 2017, in the amount of $850,000, were subject to compensation committee approval and meeting certain future funding conditions. On February 28, 2018, the funding conditions were met. The senior officers were granted their guaranteed and discretionary bonuses for the year ended December 31, 2018, in the aggregate amount of $3,415,000, which was paid in January 2019. Additionally, the agreements provided for equity incentives of up to an aggregate maximum of 8.0% of the Company’s fully diluted outstanding shares upon the attainment of certain milestones. On March 1, 2018, a funding milestone was met. Accordingly, the employees were issued an aggregate of 3% of the fully-diluted outstanding shares of the Company as of such date. On June 7, 2018, an additional milestone was met. Accordingly, the employees were issued an aggregate of 5% of the fully-diluted outstanding shares of the Company as of such date (see Note 11). The employees are also entitled to participate in all incentive and deferred compensation and employee benefit programs available to employees and executive officers of the Company. Future obligations to be paid under these agreements equal $1,258,750, as of December 31, 2018. Consulting and other Agreements Effective September 28, 2015, the Company entered into a three-year consulting agreement with a consultant to provide ongoing strategic advice and to serve on the Company’s board of directors. In connection with the agreement, the Company issued 662,910 restricted Ordinary Shares. Under the consulting agreement, such shares were subject to forfeiture ratably over a period of three years if the consultant does not remain a consultant to the Company. The shares were valued at $7.72 per share and were charged to general and administrative expenses upon the expiration of each forfeiture period. For the years ended December 31, 2018 and 2017, the Company recorded $263,970 and $351,960, respectively, in general and administrative expense under this agreement. There are no future obligations to be paid under the agreement. Research Agreements On April 24, 2015, the Company entered into a cooperative research and development agreement (CRADA) with the U.S. Department of Health & Human Services, as represented by the National Institute of Dental and Craniofacial Research (NIDCR) and Institute or Center of the National Institutes of Health (NIH). The CRADA provided for quarterly payments of $21,250 for three years through April 30, 2017 and a cost per patient for each patient enrolled in the Company’s xerostomia clinical trial. The CRADA was amended on March 25, 2016 to extend the term through March 25, 2021 and to extend the annual payments throughout the revised term. Research and development expenses under the CRADA for the years ended December 31, 2018 and 2017 were $111,938 and $115,374, respectively. Future obligations to be paid under the CRADA, as amended, through March 25, 2021 equal $191,250. On March 22, 2016, the Company entered into another CRADA with the NIDCR and NIH for the treatment of Sjögren’s syndrome Sjögren’s syndrome Effective December 5, 2016, the Company entered into a three-year research collaboration agreement with Cornell University. Pursuant to the agreement, Cornell University provides research and development under the direction of the Company. In connection with the agreement, in July 2017, the Company issued 25,000 Ordinary Shares to Cornell University, which were recorded as research and development expenses in the amount of $17,000. The Company amended this agreement, effective June 12, 2017, to add a second three-year research collaboration project through September 2019. The Company further amended this agreement, effective October 18, 2018 to include additional costs related to the research. Total research and development expenses under this agreement, as amended, for the years ended December 31, 2018 and 2017 were $1,625,152 and $1,029,904, respectively. Future obligations to be paid under the agreement through December 5, 2019 equal $2,002,228. On February 14, 2017, the Company entered into a one-year research collaboration agreement with Cornell University in the amount of $679,473. On August 24, 2017, the agreement was amended to add an additional study in the amount of $182,520. Total research and development expenses under this agreement for the years ended December 31, 2018 and 2017 were $143,073 and $698,307, respectively. License Agreements Effective February 4, 2015, 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, as amended, the Company will pay UCL Business certain sales milestone payments, if achieved, in the aggregate amount of £39.8 million, or approximately $50.7 million using the exchange rate at December 31, 2018, and royalties on net sales, as defined upon commercialization. Additionally, the Company is responsible for all patent prosecution and maintenance costs incurred and will also pay UCL Business an annual maintenance fee of £50,000, or approximately $64,000, 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 Effective July 28, 2017, the Company entered into another exclusive worldwide license agreement with UCL Business for an additional program using certain ocular gene therapy technology. The Company will pay UCL Business certain milestone payments, royalties and annual maintenance fees under the same terms and conditions as the license dated February 4, 2015. Total research and development expenses under the agreement for the years ended December 31, 2018 and 2017 were $66,630 and $82,260, respectively. Effective March 15, 2018, the Company entered into another exclusive worldwide license agreement with UCL Business for an additional program using certain ocular gene therapy technology. The Company will pay UCL Business certain milestone payments, royalties and annual maintenance fees under the same terms and conditions as the license dated February 4, 2015. Total research and development expenses under the agreement for the years ended December 31, 2018 and 2017 were $133,728 and $0, respectively. On September 7, 2018, the Company entered into an exclusive licensing agreement with the National Institutes of Health for worldwide rights to expanded indications for use of AAV-AQP1 for treatment of xerostomia (dry mouth) and xerophthalmia (dry eye) associated with Sjögren’s syndrome. Effective January 1, 2016, the Company entered into an Agreement (“Agreement”) and Plan of Merger to acquire all of the outstanding shares of BRI-Alzan from the shareholders of BRI-Alzan. In connection with the Agreement, the Company will pay certain development milestone payments if achieved, in the aggregate amount of $4.5 million, and annual royalty payments on annual net sales following the first commercial sale of any product containing the technology acquired. Total research and development expenses under the agreement for the years ended December 31, 2018 and 2017 were $15,000 and $30,000, respectively. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2018 | |
Postemployment Benefits [Abstract] | |
Employee Benefit Plans | 17. Employee Benefit Plans United States On January 1, 2017, Meira LLC adopted a defined contribution retirement plan that complies with Section 401(k) of the Internal Revenue Code. All Meira LLC employees over the age of 21 are eligible to participate in the plan after three consecutive months of service. Employees are able to defer a portion of their pay into the plan on the first day of the month or after the day all age and service requirements have been met. The plan provides for a Company matching contribution. All eligible employees receive an employer matching contribution equal to the lesser of the amount the employee contributes to the plan or 6% of their salary up to the annual IRS limit. United Kingdom On August 1, 2016, Meira UK II adopted a defined contribution group personal pension plan that complies with HM Revenue and Customs (HMRC) for tax relief. All Meira UK II employees are eligible to participate in the plan upon joining the company and providing the required services. All eligible employees, if they elect to join the pension scheme, receive an employer pension contribution equal to 7.5% to 10.0% of their pensionable earnings. Currently, employees are not required to contribute, but may make optional contributions up to the annual allowance HMRC limits. Under the HMRC requirements, current required 6+minimum employer contributions are 5-6% but will rise to 8-9% after April 2019. During the years ended December 31, 2018 and 2017, employer contributions to all plans were $440,368 and $252,700, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 18. Subsequent Events: Management has evaluated subsequent events through the date these financial statements were issued. Based on our evaluation, the following disclosures have been made: License Agreement On January 29, 2019, the Company amended and restated the following agreements: (i) the License Agreement, dated February 4, 2015, as amended, between the Company and UCL Business, Plc (“UCLB”); (ii) the License Agreement, dated July 28, 2017, as amended, between the Company and UCLB; and (iii) the License Agreement, dated March 15, 2018, between the Company and UCLB to establish new stand-alone license agreements for the following inherited retinal disease programs: (a) achromatopsia (“ACHM”) caused by mutations in CNGB3; (b) ACHM caused by mutations in CNGA3; (c) X-linked retinitis pigmentosa (“XLRP”); and (d) RPE65-mediated IRD. The Company’s obligation to pay UCLB a share of certain sublicensing revenues, as was provided under the February 4, 2015 agreement, has been removed from each of the stand-alone agreements. Each of the stand-alone agreements now reflects terms substantially similar to those of the March 15, 2018 agreement. Additionally, the new stand-alone agreement related to CNGB3 provides for the Company to pay UCLB an upfront payment of £1,500,000, or approximately $1,976,000, and issue £1,500,000 of the Company’s ordinary shares. Collaboration Agreement On January 30, 2019, (the “Agreement Date”), the Company entered into a Collaboration Agreement with Janssen Pharmaceuticals, Inc. (“Janssen”) for the research, development and commercialization of gene therapies for the treatment of inherited retinal diseases (“IRDs”). Under the terms of the agreement, the Company will receive a $100 million cash upfront payment. Janssen and the Company will collaborate to develop the Company’s current clinical programs in Retinitis Pigmentosa and two genetic forms of Achromatopsia and Janssen has the exclusive right to commercialize these products globally. The Company will manufacture these products for commercial supply. Janssen will pay 100% of the clinical and commercialization costs of the products and the Company is eligible to receive untiered 20 percent royalties on net sales of products and additional development and commercialization milestones of up to $340 million. In addition, the Company and Janssen have entered into a research collaboration in the area of IRDs, with Janssen paying for the majority of the research costs. Janssen has the right to exclusively license any product coming out of the collaboration at the time of IND. Janssen will then pay 100% of the clinical and commercialization costs for these products and the Company will receive an untiered royalty on net sales in the high teens as well as development milestones. In addition, Janssen and the Company have entered into a manufacturing research collaboration to further develop processes for manufacturing AAV viral vectors in which the costs of the research will be shared. Private Placement On February 27, 2018, the Company issued 5,797,102 Ordinary Shares in a private placement for gross proceeds of $80 million, excluding offering costs of approximately $2.6 million. Johnson & Johnson Innovation – JJDC, Inc., the investment arm of Johnson and Johnson, led the offering and purchased 2,898,550 of the Ordinary shares issued on the same terms and conditions as the other investors in the offering. In connection with the offering, the Company also entered into a registration rights agreement whereby, promptly following the date on which the Company becomes eligible to use a registration statement on Form S-3, but in no event later than July 31, 2019, the Company shall prepare and file a registration statement covering the resale of all of the Registrable Securities, as defined in the agreement. The Company shall use commercially reasonable efforts to have the registration statement declared effective as soon as practicable. If the registration statement is not declared effective prior to the 120th day after July 31, 2019 (or the 150th day if the Securities and Exchange Commission reviews such registration statement), then the Company will make pro rata payments in cash to each investor then holding Registrable Securities, as liquidated damages, in an amount equal to 1% of the aggregate amount invested by such investor for each thirty (30)-day period or pro rata for any portion thereof following the date by which such registration statement should have been effective. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Consolidation | Consolidation The accompanying 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 Neurosciences, Inc. a Delaware corporation (“Meira Neuro”); MeiraGTx UK II Limited, (“Meira UK II”), a limited company under the laws of England and Wales; and 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 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 (“A Ordinary Shares”) issued prior to the Company’s initial public offering, the accounting for research and development costs, warrants, share-based compensation and accrued expenses. |
Subsequent Events | Subsequent Events The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The Company evaluated all events and transactions through March 26, 2019, the date these consolidated financial statements were issued. See Note 18 for additional information. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid instruments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits that are readily convertible into cash. |
Warrant Liability | Warrant Liability During 2017, the Company issued warrants to purchase Convertible Preferred C Shares (the “Preferred Shares”) to certain investors. Due to the potential redemption feature of the underlying Preferred Shares, the warrants had been classified as a liability. Liability accounting requires that the fair value of warrants be remeasured each reporting period with changes recorded in the statements of operations and comprehensive loss. These Preferred Shares warrants remained outstanding until their exercise in June 2018, at which time the warrant liability was remeasured to fair value and reclassified to additional paid-in capital. |
Financial Instruments | Financial Instruments The carrying value of prepaid expenses, other current assets, accounts payable, accrued expenses, notes payable and amounts due to an affiliate reported in the consolidated balance sheets equal or approximate fair value due to their short maturities. |
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 risk including our own credit risk. 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 Company’s financial assets and liabilities that are required to be measured at fair value on a recurring basis: Fair Value Measurement Using: Description December 31, 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, 2016 to December 31, 2018: Significant Significant Other Significant Balance as of December 31, 2016 $ 444,844 $ — $ — Cash released from restriction (321,468 ) — — Fair value of warrants issued — — 2,214,000 Change in fair value of warrants — — 465,633 Balance as of December 31, 2017 123,376 — 2,679,633 Change in fair value of warrants 1,514,775 Exercise of warrants — — (4,194,408 ) Balance as of December 31, 2018 $ 123,376 $ — $ — 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 $1,514,775 for the year ended December 31, 2018. The related warrant liability of $4,194,408 was reclassified as Capital in Excess of Nominal Value at such time. The fair values of the warrants were estimated using the Black-Scholes valuation model with the following assumptions: June 4, 2018 December 31, 2017 September 21, 2017 Risk-free interest rate 1.77 % 1.72 % 1.38 % Expected volatility 80 % 80 % 80 % Expected dividend yield 0 0 0 Expected life 1 day 9 months 18 months 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, as described in Note 12. The fair value of the Preferred Shares were based upon recent issuances of the Company’s Preferred Shares on or about those dates. The estimated fair values of the Company’s warrants were not necessarily indicative of the amounts that would have been realized in a current market exchange. The determination of the fair value of the warrants were sensitive to changes 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. |
Convertible Preferred C Shares | Convertible Preferred C Shares The Preferred Shares were not redeemable, except in the event of a change of control which was outside the control of the Company and required shareholder approval. The redemption value of the Preferred Shares upon a change in control is equal to its liquidation value described below. The Company is accounting for its Preferred Shares under the requirements of ASC 480, Distinguishing Liabilities from Equity, |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company maintains its cash and cash equivalents primarily in depository and money market accounts within two large financial institutions in the United States and one large financial institution in the United Kingdom. Cash balances deposited at these major financial banking institutions exceed the insured limit. The Company has not experienced any losses on its bank deposits and believes these deposits do not expose the Company to any significant credit risk. |
Property, Plant and Equipment, Net | Property, Plant and Equipment, Net Property, plant and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are depreciated over the lesser of their useful lives or the life of the lease (see Note 5). The estimated useful lives of the asset categories are set forth in the table below: Asset Category Useful Lives Computer and office equipment 3 years Laboratory equipment 5 years Manufacturing equipment 7 years Furniture and fixtures 5 years Capitalized leasehold interest 25 years Leasehold improvements lesser of useful Expenditures for leasehold improvements are capitalized, and expenditures for maintenance and repairs are expensed to operations as incurred. ASC Topic 360, Property, Plant and Equipment |
Net Loss per Ordinary Share | Net Loss per Ordinary Share Basic net loss per Ordinary Share is computed by dividing net loss 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 method, whichever is more dilutive. For all periods presented, basic and diluted net loss per Ordinary Share are the same, as any additional Ordinary Share equivalents would be anti-dilutive (see Note 13). |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2018 and 2017, the Company does not have any significant uncertain tax positions. The Company is required to estimate income taxes in each of the jurisdictions in which it operates. The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized. As of December 31, 2018, the Company had no unrecognized tax benefits or related interest and penalties accrued. In the United States, on December 22, 2017, the “Tax Cuts and Jobs Act” (the “Act”) was signed into law. Substantially all of the provisions of the Act are effective for taxable years beginning after December 31, 2017. The Act includes significant changes to the Internal Revenue Code of 1986 (as amended, the “Code”), including amendments which significantly change the taxation of individuals, and business entities. The Act contains numerous provisions impacting the Company, the most significant of which reduces the Federal corporate statutory tax rate from 34% to 21%. The staff of the U.S. Securities and Exchange Commission (“SEC”) has recognized the complexity of reflecting the impacts of the Act, and on December 22, 2017 issued guidance in Staff Accounting Bulletin 118 (“SAB 118”), which clarifies accounting for income taxes under ASC 740 if information is not yet available or complete and provides for up to a one year period in which to complete the required analyses and accounting (the measurement period). SAB 118 describes three scenarios (or “buckets”) associated with a company’s status of accounting for income tax reform: (1) a company is complete with its accounting for certain effects of tax reform, (2) a company is able to determine a reasonable estimate for certain effects of tax reform and records that estimate as a provisional amount, or (3) a company is not able to determine a reasonable estimate and therefore continues to apply ASC 740, based on the provisions of the tax laws that were in effect immediately prior to the Act being enacted. The various provisions under the Act deemed most relevant to the Company have been considered in preparation of its financial statements as of December 31, 2017. The Company had made a reasonable estimate for certain effects of tax reform and had recorded provisional amounts as part of its income tax provision. To the extent that clarifications or interpretations materialized in the future that would impact upon the effects of the Act incorporated into the December 31, 2017 financial statements, those effects would have been reflected in the future as or if they materialize. As of December 31, 2018, the Company has completed its accounting for all of the tax effects of the Act. Based on the additional analysis performed, no adjustments to the provisional amounts were made in the reporting period which had an impact to the tax provision or consolidated financial statements. |
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; facilities; supplies; rent, insurance, certain legal fees, share-based compensation, depreciation, other costs associated with clinical and preclinical activities and regulatory operations and acquisition of in-process research and development write-offs. Refundable research and development credits / tax credits received are recorded as an offset to these costs. 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 consolidated financial statements as prepaid or accrued research and development expense, as the case may be. |
Share-Based Compensation Expense | Share-Based Compensation Expense Options The Company grants share options to employees, non-employee members of the Company’s board of directors and non-employee consultants as compensation for services performed. Employee and non-employee members of the board of directors’ awards of share-based compensation are accounted for in accordance with ASC 718, Compensation Stock Compensation, . Using this model, fair value is calculated based on assumptions with respect to (i) the fair value of the Company’s Ordinary Shares on the grant date; (ii) expected volatility of the Company’s Ordinary Share price, (iii) the periods of time over which employees and members of the Company’s board of directors are expected to hold their options prior to exercise (expected term), (iv) expected dividend yield on the Company’s Ordinary Shares, and (v) risk-free interest rates. As there had been no public market for the Company’s Ordinary Shares until the Company’s IPO on June 7, 2018, the estimated fair value of the Ordinary Shares until that time had been determined by the Company’s board of directors as of the date of each option grant, with input from management, considering the most recently available third-party valuations of Ordinary Shares and the board of directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. The fair value of Ordinary Shares after the Company’s IPO was determined based upon the closing share price on the date of grant. The third party estimated the fair value of the equity using a special case of the market approach known as the backsolve method. The backsolve method was used to solve for the implied total equity value based on the Company’s recent Series C financing round. Consideration was given to the rights and preferences of each of the Company’s classes of equity and the expected time to a liquidity event. An option pricing allocation method, or OPM, was selected to allocate the total equity value. The OPM treats ordinary shares and preferred shares as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the Ordinary Shares have value only if the funds available for distribution to shareholders exceeded the value of the Preferred Shares’ liquidation preference at the time of the liquidity event, such as a strategic sale or a merger. These third-party valuations resulted in a valuation of the Company’s Ordinary Shares of $7.57, $2.64 and $5.63 per share as of December 31, 2016, September 15, 2017 and December 31, 2017, respectively. The assumptions underlying these valuations represented management’s best estimate, which involved inherent uncertainties and the application of management’s judgment. As a result, if the Company had used different assumptions or estimates, the fair value of its Ordinary Shares and its share-based compensation expense could have been materially different. Since the Company’s Ordinary Shares had not been traded on a public exchange prior to the Company’s IPO and have only been traded on a public exchange for a short period of time since the Company’s IPO, the Company believes that it does not have sufficient company-specific information available to determine the expected term based on its historical data. As a result, the expected term of share options granted to employees and members of the Company’s board of directors is determined using the average of the vesting period and contractual life of the option, an accepted method for the Company’s option grants under the SEC’s Staff Accounting Bulletin No. 107 and No. 110, Share-Based Payment. Similarly, the Company believes that its future volatility will differ materially during the expected term from the volatility that would be calculated from its historical share prices to date. Consequently, expected volatility is based on an analysis of guideline companies in accordance with ASC 718. The expected dividend yield is zero as the Company has never paid dividends and does not currently anticipate paying any in the foreseeable future. Risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the option’s expected term. The Company accounted for options granted to non-employee consultants under ASC 505-50, Equity-Based Payments to Non-Employees, . On July 1, 2018, the Company early adopted ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting all |
Restricted Shares | Restricted Shares In connection with certain service agreements and research agreements, the Company has granted restricted Ordinary Shares as compensation. The Ordinary Shares are recognized in the consolidated statements of operations and comprehensive loss based on their grant date fair values. Compensation cost relating to share grants with service-based graded vesting schedules is recognized based on the vesting schedule. |
Leases | Leases The Company recognizes rent expense for operating leases on a straight-line basis over the term of the lease, beginning on the date the Company takes possession of the property. Rent expense includes the base amounts stated in the lease agreement as well as the effect of reduced or free rent and rent escalations. At lease inception, the Company determines the lease term by assuming the exercise of those renewal options that are reasonably assured because of the significant economic penalty that exists for not exercising those options. The expected lease term is one of the factors used to determine whether a lease is classified as an operating or capital lease and is used to calculate the straight-line rent expense. The difference between the cash paid to the landlord and the amount recognized as rent expense on a straight-line basis is included in deferred rent and classified within long-term liabilities. Lease incentives made by landlords to or on behalf of the Company for leasehold improvements are recorded as deferred rent and classified as long-term liabilities. |
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 on our Consolidated Balance Sheets 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 folows: For the year ended 2018 2017 Balance at beginning of year $ 178,419 $ 221,254 Inception of asset retirement obligation 69,286 — Amortization of interest (38,301 ) 19,313 Change in estimate (99,090 ) (75,011 ) Effects of exchange rate 17,805 12,863 Balance at end of year $ 128,119 $ 178,419 |
Other Comprehensive Income (Loss) | Other Comprehensive Income (Loss) Other comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. The only component of other comprehensive income (loss) impacting the Company is foreign currency translation. |
Foreign Currencies | Foreign Currencies The Company’s consolidated financial statements are presented in U.S. dollars, the reporting currency of the Company. The financial position and results of operations of Meira UK II and Meira B.V. are measured using the foreign subsidiaries’ local currency as the functional currency. Meira UK II’s cash accounts holding U.S. dollars are remeasured based upon the exchange rate at the date of remeasurement with the resulting gain or loss included in the consolidated statements of operations and comprehensive loss. Expenses of such subsidiaries have been translated into U.S. dollars at average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the consolidated balance sheets dates. The resulting translation gain and loss adjustments are recorded directly as a separate component of shareholders’ equity and as other comprehensive loss on the consolidated statements of operations and comprehensive loss. |
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 assets by geographical area: December 31, December 31, United States $ 454,568 $ 436,463 United Kingdom 21,788,130 13,942,642 $ 22,242,698 $ 14,379,105 |
Accounting Pronouncements Recently Adopted | Accounting Pronouncements Recently Adopted In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, all In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business, , In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, In November 2016, the Financial Accounting Standards Board, or FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash In May 2016, the FASB issued ASU No. 2016-12 , Revenue from Contracts with Customers (Topic 606), Narrow-Scope Improvements and Practical Expedients Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date . Revenue from Contracts with Customers (Topic 606), Identifying Performance Obligations and Licensing , Revenue from Contracts with Customers (Topic 606), Principal versus Agent Considerations (Reporting Revenue Gross versus Net) In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. Technical Corrections and Improvements to Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, |
Recent Accounting Pronouncements Not Yet Adopted | Recent Accounting Pronouncements Not Yet Adopted In November 2018, the FASB issued Accounting Standards Update No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”). The standard amends Accounting Standards Codification 808, Collaborative Agreements and Accounting Standards Codification 606, Revenue from Contracts with Customers, to clarify the interaction between collaborative arrangement participants that should be accounted for as revenue under ASC 606. In transactions when the collaborative arrangement participant is a customer in the context of a unit of account, revenue should be accounted for using the guidance in Topic 606. The amendments in Update No. 2018-18 are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The Company is currently evaluating the new guidance included in ASU 2018-18, but does not expect it to have a material impact on its consolidated financial statements. In October 2016, the FASB issued ASU 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other than Inventory In February 2016, the FASB issued ASU No. 2016-02, “Leases” (ASC 842). The amended guidance requires lessees to recognize lease liabilities and right-of-use assets on the balance sheet for all leases with terms longer than 12 months and provides enhanced disclosures on key information of leasing arrangements. In July 2018, further amendments were issued to clarify how to apply certain aspects of the amended lease guidance and to address certain implementation issues. The amended guidance is effective for us commencing in the first quarter of 2019. Early adoption is permitted. We plan to adopt the amended guidance on the effective date and expect to elect the package of practical expedients. We expect the adoption of the amended guidance will materially affect our consolidated balance sheet and that the primary impact will be recognition of minimum commitments at present value of our noncancelable operating leases as lease liabilities and corresponding right-of-use assets. In July 2018, the FASB issued ASU No. 2018-10, which provides narrow amendments to ASU No. 2016-02 to clarify how to apply the rate implicit in the lease, impairment of the net investment in the lease, lessee reassessment of lease classification, variable payments that depend on an index or rate and certain transition adjustments. In July 2018, the FASB also issued ASU No. 2018-11, which provides targeted improvements to ASU No. 2016-02 to provide entities the transition option to not apply the standard in the comparative periods presented in the year of adoption. The Company will adopt the new standard effective January 1, 2019 using the modified retrospective transition method using the practical expedients model and a discount rate in the range of 8% to 10%, and elect to not apply the standard in the comparative periods presented in the year of adoption. We estimate that upon implementation, we will record a right-of-use asset between $3.3 million and $3.6 million and a corresponding liability between $3.6 million and $3.8 million. We are continuing to evaluate the impact that the amended lease guidance will have on our consolidated financial statements, systems, processes and internal controls. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Company's Financial Assets and Liabilities Measured at Fair Value | The table below represents the values of the Company’s financial assets and liabilities that are required to be measured at fair value on a recurring basis: Fair Value Measurement Using: Description December 31, 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, 2016 to December 31, 2018: Significant Significant Other Significant Balance as of December 31, 2016 $ 444,844 $ — $ — Cash released from restriction (321,468 ) — — Fair value of warrants issued — — 2,214,000 Change in fair value of warrants — — 465,633 Balance as of December 31, 2017 123,376 — 2,679,633 Change in fair value of warrants 1,514,775 Exercise of warrants — — (4,194,408 ) Balance as of December 31, 2018 $ 123,376 $ — $ — |
Fair Values of Warrants Estimated by Using Black-Scholes Valuation Model | The fair values of the warrants were estimated using the Black-Scholes valuation model with the following assumptions: June 4, 2018 December 31, 2017 September 21, 2017 Risk-free interest rate 1.77 % 1.72 % 1.38 % Expected volatility 80 % 80 % 80 % Expected dividend yield 0 0 0 Expected life 1 day 9 months 18 months |
Schedule Of Estimated Useful Lives Of Assets | The estimated useful lives of the asset categories are set forth in the table below: Asset Category Useful Lives Computer and office equipment 3 years Laboratory equipment 5 years Manufacturing equipment 7 years Furniture and fixtures 5 years Capitalized leasehold interest 25 years Leasehold improvements lesser of useful |
Schedule of change in asset retirement obligations | The change in asset retirement obligations is as folows: For the year ended 2018 2017 Balance at beginning of year $ 178,419 $ 221,254 Inception of asset retirement obligation 69,286 — Amortization of interest (38,301 ) 19,313 Change in estimate (99,090 ) (75,011 ) Effects of exchange rate 17,805 12,863 Balance at end of year $ 128,119 $ 178,419 |
Summary of Non-Current Assets by Geographical Area | The following table summarizes non-current assets by geographical area: December 31, December 31, United States $ 454,568 $ 436,463 United Kingdom 21,788,130 13,942,642 $ 22,242,698 $ 14,379,105 |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Other Income and Expenses [Abstract] | |
Summary of Prepaid Expenses | Prepaid expenses at December 31, 2018 and 2017 consist of the following: December 31, December 31, Insurance $ 623,314 $ 163,284 Clinical Trial Costs 373,723 839,644 Research and Development 352,658 624,348 Other 330,233 160,595 Dues and License Fees 169,073 145,594 Rent 88,784 27,778 $ 1,937,785 $ 1,961,243 |
Property, Plant and Equipment_2
Property, Plant and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment, Net | Property, plant and equipment, net at December 31, 2018 and 2017 consist of the following: December 31, December 31, Leasehold Improvements $ 11,538,377 $ 10,873,895 Capitalized Leasehold Interest 7,150,611 — Manufacturing Equipment 3,779,950 2,477,637 Laboratory Equipment 1,485,544 993,409 Computer and Office Equipment 334,525 276,100 Asset Retirement Obligation 113,678 153,133 Furniture & Fixtures 88,660 93,786 24,491,345 14,867,960 Less: Accumulated depreciation (2,477,108 ) (612,231 ) $ 22,014,237 $ 14,255,729 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses at December 31, 2018 and 2017 were comprised of the following: December 31, December 31, Compensation and Benefits $ 5,731,438 $ 2,386,903 Clinical Trial Costs 4,013,094 4,859,410 Professional Fees 914,540 231,923 Consulting 821,009 1,220,477 Research and Development 236,271 73,379 Rent 122,770 387,267 Interest 40,800 33,437 Other 111,775 140,148 $ 11,991,697 $ 9,332,944 |
Capitalized Leases (Tables)
Capitalized Leases (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Text Block [Abstract] | |
Schedule of Future Minimum Lease Payments | The following is a schedule, by year, of future minimum lease payments under the capital leases together with the present value of the net minimum lease payments as of December 31, 2018: 2019 28,715 2020 7,179 Total minimum lease payments 35,894 Less: amount representing interest (1,598 ) Present value of net minimum lease payments 34,296 Less: current portion (27,199 ) Obligations under capital lease, less current portion $ 7,097 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 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 members of the board of directors and non-employee consultants as of and for the years ended December 31, 2018 and 2017 is as follows: STOCK OPTION TABLE Number of Weighted- Aggregate Outstanding at December 31, 2016 333,660 $ 7.72 Granted 611,933 3.73 Exercised (1,288 ) (7.57 ) Expired — — Forfeited (5,668 ) (7.72 ) Outstanding at December 31, 2017 938,637 $ 5.12 Granted 2,334,285 8.63 Exercised — — Expired — — Forfeited (10,557 ) (5.51 ) Outstanding at December 31, 2018 3,262,365 $ 7.64 $ 6,903,313 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 December 31, 2018 (yrs) 9.24 Options exercisable at December 31, 2017 186,394 $ 7.72 Options exercisable at December 31, 2018 535,241 $ 5.79 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 December 31, 2018 (yrs) 7.88 |
Schedule of Grant Date Fair Values of the Stock Option Granted | The grant date fair values of the stock options granted were estimated using the Black-Scholes option valuation model with the following ranges of assumptions (see Note 2): 2018 2017 Risk-free interest rate 2.32% - 2.98% 2.28% - 2.51% Expected volatility 90% 80% Expected dividend yield 0% 0% Expected life (in years) 5.5 - 10.0 5.5 - 10.0 |
Summary of Restricted Ordinary Shares | A summary of the restricted Ordinary Shares is as follows: Ordinary Shares $ Value Non-vested at December 31, 2016 386,608 $ 3,020,191 Vesting during 2017 (280,695 ) (2,154,330 ) Non-vested at December 31, 2017 105,913 865,861 Issued during 2018 1,306,348 19,595,220 Vesting during 2018 (759,087 ) (10,663,471 ) Non-vested at December 31, 2018 653,174 $ 9,797,610 |
Schedule of Share Based Compensation Expense | During the years ended December 31, 2018 and 2017 the Company recognized total share-based compensation expense in the accompanying consolidated statements of operations and comprehensive loss as follows: 2018 2017 Research and development $ 3,372,054 $ 2,374,899 General and administrative 14,511,500 584,832 Total share based compensation $ 17,883,554 $ 2,959,731 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 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: 2018 2017 Net loss—basic and diluted $ (82,865,874 ) $ (31,044,535 ) Accretion of Preferred Shares financing costs (1,806,512 ) (191,963 ) Accretion of warrant — (615,000 ) Adjusted net loss—basic and diluted $ (84,672,386 ) $ (31,851,498 ) Weighted-average ordinary shares outstanding: Basic and Diluted 18,948,520 8,572,315 Net loss per share: Basic and Diluted $ (4.47 ) $ (3.72 ) |
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: December 31, December 31, Preferred Shares — 5,005,934 Restricted Ordinary Shares subject to forfeiture 653,174 105,913 Stock options 3,262,365 938,637 Warrants — 927,594 3,915,539 6,978,078 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Company's Pre Tax Earnings | The Company’s pre tax earnings from the United Kingdom and United States locations are as follows: December 31, December 31, United Kingdom $ (73,359,977 ) $ (26,458,625 ) United States (9,980,287 ) (4,585,910 ) $ (83,340,264 ) $ (31,044,535 ) |
Schedule of Reconciliation of Income Tax Benefit with Amounts at the U.K. Statutory Income Tax Rate | The following table summarizes a reconciliation of income tax benefit compared with the amounts at the U.K. statutory income tax rate: December 31, December 31, Statutory rate (15,834,650 ) 19.00 % (5,976,073 ) 19.25 % Permanent differences—other 1,438,934 -1.73 % 654,648 -2.11 % RTP and other adjustments 387,509 -0.46 % (152,948 ) 0.49 % U.K. tax credit 1,707,489 -2.05 % 539,136 -1.74 % U.S. tax credit (436,250 ) 0.52 % (363,665 ) 1.17 % Foreign tax rate differential (171,693 ) 0.21 % (673,619 ) 2.17 % State and local rate, net of federal tax (1,159,522 ) 1.39 % (446,683 ) 1.44 % UK Rate Change (17% at expected DTA turn) 1,104,863 -1.33 % 482,351 -1.55 % U.S. state rate change (6,496 ) 0.01 % 993,998 -3.20 % Change in valuation allowance 12,495,426 -14.99 % 4,942,855 -15.92 % Actual income tax benefit effective tax rate (474,391 ) 0.57 % — 0.00 % |
Schedule of Expense/(Benefit) for Income Taxes from Continuing Operations | The Expense/(Benefit) for income taxes from continuing operations consists of the following: December 31, December 31, Current Tax Expense/(Benefit) United Kingdom — — United States — — Total Current — — Deferred Tax Expense/(Benefit) United Kingdom $ (8,888,096 ) $ (3,759,109 ) United States (3,606,275 ) (1,183,746 ) Total Deferred (12,494,371 ) (4,942,855 ) Change in Valuation Allowance 12,019,880 4,942,855 Total Income Tax Expense/(Benefit) $ (474,391 ) $ — |
Schedule of Deferred Tax Assets and Liabilities | Deferred Tax Assets/(Liabilities) December 31, 2018 Total UK US Deferred Tax Assets: Net operating loss carryforwards $ 20,646,185 $ 16,000,329 $ 4,645,856 Other 1,414,690 (46,604 ) 1,461,294 Tax Credit 1,133,656 — 1,133,656 Deferred tax assets 23,194,531 15,953,725 7,240,806 Less: valuation allowance (23,194,531 ) (15,953,725 ) (7,240,806 ) Net deferred tax asset $ — $ — $ — December 31, 2017 Total UK US Deferred Tax Assets: Net operating loss carryforwards $ 9,462,690 $ 6,909,754 $ 2,552,937 Other 539,008 152,554 386,454 Tax Credit 697,406 — 697,406 Deferred tax assets 10,699,105 7,062,308 3,636,797 Less: valuation allowance (10,699,105 ) (7,062,308 ) (3,636,797 ) Net deferred tax asset $ — $ — $ — |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Incurred Charges Included in Loss from Operations | During the years ended December 31, 2018 and 2017, the Company incurred the following charges in connection with the TSA which are included in loss from operations: 2018 2017 Rent $ 557,698 $ 548,229 Personnel 6,493 39,721 Other 6,334 5,983 Total charges incurred $ 570,525 $ 593,933 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Schedule of Future Minimum Rental Payments | The aggregate future minimum rental payments of all leases, including those discussed in Note 15 are as follows: 2019 $ 889,465 2020 $ 904,716 2021 $ 924,121 2022 $ 350,284 2023 $ 350,284 Thereafter $ 1,196,805 Total future rent payments $ 4,615,675 |
July 27, 2018 Lease [Member] | |
Schedule of Future Minimum Rental Payments | The aggregate future minimum rental payments under these operating leases are as follows: 2019 $ 353,782 2020 $ 350,284 2021 $ 350,284 2022 $ 350,284 2023 $ 350,284 Thereafter $ 1,196,805 Total future rent payments $ 2,951,723 |
Principal Business Activity - A
Principal Business Activity - Additional Information (Detail) | Feb. 27, 2019USD ($)shares | Jan. 30, 2019USD ($) | Jun. 07, 2018USD ($)$ / sharesshares | Mar. 01, 2018shares | Dec. 31, 2018USD ($)shares | Feb. 27, 2018shares | Dec. 31, 2017USD ($)shares |
Schedule Of Description Of Business [Line Items] | |||||||
Reverse share split ratio | 0.257 | ||||||
Accumulated deficit | $ (148,289,717) | $ (65,423,843) | |||||
Cash and cash equivalents | $ 68,080,175 | $ 8,548,638 | |||||
Common stock, shares issued | shares | 27,386,632 | 8,826,190 | |||||
Proceeds from the sale of ordinary shares | $ 69,750,000 | ||||||
Private Placement [Member] | |||||||
Schedule Of Description Of Business [Line Items] | |||||||
Common stock, shares issued | shares | 5,797,102 | ||||||
JJDC [Member] | Private Placement [Member] | |||||||
Schedule Of Description Of Business [Line Items] | |||||||
Common stock, shares issued | shares | 2,898,550 | ||||||
Subsequent Event [Member] | Collaboration Option And License Agreement [Member] | JJDC [Member] | Private Placement [Member] | |||||||
Schedule Of Description Of Business [Line Items] | |||||||
Common stock, shares issued | shares | 5,797,102 | ||||||
Proceeds from the sale of ordinary shares | $ 80,000,000 | ||||||
Proceeds from issuance of common stock, net | $ 77,400,000 | ||||||
Subsequent Event [Member] | Collaboration Option And License Agreement [Member] | Janssen Pharmaceuticals Inc [Member] | |||||||
Schedule Of Description Of Business [Line Items] | |||||||
Upfront payment | $ 100,000,000 | ||||||
Minimum [Member] | Collaboration Option And License Agreement [Member] | JJDC [Member] | |||||||
Schedule Of Description Of Business [Line Items] | |||||||
Offsetting expense, period | 12 months | ||||||
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 | $ 65,200,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Company's Financial Assets and Liabilities Measured at Fair Value (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) | Dec. 31, 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 Accoun_5
Summary of Significant Accounting Policies - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Change in fair value of warrants | $ 1,514,775 | $ 465,633 |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Beginning balance | 444,844 | |
Cash released from restriction | (321,468) | |
Ending balance | 123,376 | 123,376 |
Fair Value, Inputs, Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of warrants issued | 2,214,000 | |
Change in fair value of warrants | 1,514,775 | 465,633 |
Exercise of warrants | $ (4,194,408) | |
Ending balance | $ 2,679,633 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 12 Months Ended | |||||
Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2019 | Jun. 05, 2018 | Sep. 15, 2017 | Dec. 31, 2016 | |
Warrant liability | $ 2,679,633 | $ 4,194,408 | ||||
Change in fair value of warrants | $ 1,514,775 | 465,633 | ||||
Exercise of warrants liability | 4,194,408 | |||||
Impairment charges | 0 | 0 | ||||
Liability for uncertainty in income taxes | 0 | $ 0 | ||||
Unrecognized tax benefits, income tax penalties and interest accrued | $ 0 | |||||
Statutory tax rate | 19.00% | 19.25% | ||||
Minimum [Member] | Subsequent Event [Member] | ||||||
Discount rate | 8.00% | |||||
Operating lease right-of-use asset | $ 3,300,000 | |||||
Operating lease liability | $ 3,600,000 | |||||
Maximum [Member] | Subsequent Event [Member] | ||||||
Discount rate | 10.00% | |||||
Operating lease right-of-use asset | $ 3,600,000 | |||||
Operating lease liability | $ 3,800,000 | |||||
Valuation Technique, Option Pricing Model [Member] | ||||||
Pricing valuation of ordinary share | $ 5.63 | $ 2.64 | $ 7.57 | |||
Federal [Member] | ||||||
Statutory tax rate | 21.00% | 34.00% | ||||
Capital in Excess of Nominal Value [Member] | ||||||
Exercise of warrants liability | $ 4,194,408 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Fair Values of Warrants Estimated by Using Black-Scholes Valuation Model (Detail) - Warrants [Member] | Jun. 04, 2018 | Sep. 21, 2017 | Dec. 31, 2017 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Risk-free interest rate | 1.77% | 1.38% | 1.72% |
Expected volatility | 80.00% | 80.00% | 80.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected life | 1 day | 18 months | 9 months |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule Of Estimated Useful Lives Of Assets (Detail) | 12 Months Ended |
Dec. 31, 2018 | |
Computer Equipment And Software [Member] | |
Depreciation Amortization Impairment [Line Items] | |
Estimated useful life (years) | 3 years |
Laboratory Equipment [Member] | |
Depreciation Amortization Impairment [Line Items] | |
Estimated useful life (years) | 5 years |
Manufacturing Equipment [Member] | |
Depreciation Amortization Impairment [Line Items] | |
Estimated useful life (years) | 7 years |
Furniture & Fixtures [Member] | |
Depreciation Amortization Impairment [Line Items] | |
Estimated useful life (years) | 5 years |
Capitalized Leasehold Interest [Member] | |
Depreciation Amortization Impairment [Line Items] | |
Estimated useful life (years) | 25 years |
Leasehold Improvements [Member] | |
Depreciation Amortization Impairment [Line Items] | |
Estimated useful life (years) | lesser of useful life or remaining term of lease |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Schedule of Change in Asset Retirement Obligations (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Asset Retirement Obligation [Abstract] | ||
Balance at beginning of year | $ 178,419 | $ 221,254 |
Inception of asset retirement obligation | 69,286 | |
Amortization of interest | (38,301) | 19,313 |
Change in estimate | (99,090) | (75,011) |
Effects of exchange rate | 17,805 | 12,863 |
Balance at end of year | $ 128,119 | $ 178,419 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Summary of Non-Current Assets by Geographical Area (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Operation By Geographical [Line Items] | ||
Non current assets | $ 22,242,698 | $ 14,379,105 |
United States | ||
Operation By Geographical [Line Items] | ||
Non current assets | 454,568 | 436,463 |
United Kingdom | ||
Operation By Geographical [Line Items] | ||
Non current assets | $ 21,788,130 | $ 13,942,642 |
Asset Acquisition - Additional
Asset Acquisition - Additional Information (Detail) - USD ($) | Oct. 05, 2018 | Dec. 31, 2018 |
Acquisition Date [Line Items] | ||
Fair value of asset acquisition in process R&D | $ 2,990,250 | |
Contingent milestone payment | $ 21,000,000 | |
Vector Neurosciences Inc [Member] | ||
Acquisition Date [Line Items] | ||
Number of shares issued as initial merger consideration | 225,000 | |
Agreement date | Oct. 5, 2018 | |
Period of shares issued as initial merger consideration | 18 months | |
Vector Neurosciences Inc [Member] | Maximum [Member] | ||
Acquisition Date [Line Items] | ||
Value of stockholders additional ordinary shares | $ 21,000,000 | |
Vector Neurosciences Inc [Member] | Issued at Closing of Merger [Member] | ||
Acquisition Date [Line Items] | ||
Number of shares issued as initial merger consideration | 202,500 | |
Vector Neurosciences Inc [Member] | Issued Following Closing of Merger [Member] | ||
Acquisition Date [Line Items] | ||
Number of shares issued as initial merger consideration | 22,500 |
Prepaid Expenses - Summary of P
Prepaid Expenses - Summary of Prepaid Expenses (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Insurance | $ 623,314 | $ 163,284 |
Clinical Trial Costs | 373,723 | 839,644 |
Research and Development | 352,658 | 624,348 |
Other | 330,233 | 160,595 |
Dues and License Fees | 169,073 | 145,594 |
Rent | 88,784 | 27,778 |
Total | $ 1,937,785 | $ 1,961,243 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net - Schedule of Property, Plant and Equipment, Net (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 24,491,345 | $ 14,867,960 |
Less: Accumulated depreciation | (2,477,108) | (612,231) |
Property, plant and equipment, net | 22,014,237 | 14,255,729 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 11,538,377 | 10,873,895 |
Capitalized Leasehold Interest [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 7,150,611 | |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 3,779,950 | 2,477,637 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,485,544 | 993,409 |
Computer and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 334,525 | 276,100 |
Asset Retirement Obligation [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 113,678 | 153,133 |
Furniture & Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 88,660 | $ 93,786 |
Property, Plant & Equipment, Ne
Property, Plant & Equipment, Net - Additional Information (Detail) | Dec. 14, 2018USD ($) | Dec. 14, 2018GBP (£) | Jul. 31, 2018Lease | Dec. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2018GBP (£) | Feb. 29, 2016USD ($) |
Property, Plant and Equipment [Line Items] | |||||||||
Asset retirement obligations, noncurrent | $ 140,129 | $ 140,129 | |||||||
Asset retirement obligation | 128,119 | 128,119 | $ 178,419 | $ 221,254 | |||||
Number of operating leases | Lease | 2 | ||||||||
Capitalized lease obligation | 7,097 | 7,097 | 34,298 | ||||||
Depreciation expense | 2,053,220 | 679,177 | |||||||
Leasehold Improvements [Member] | |||||||||
Property, Plant and Equipment [Line Items] | |||||||||
Asset retirement obligation | 69,286 | 69,286 | |||||||
Capitalized Leasehold Interest [Member] | |||||||||
Property, Plant and Equipment [Line Items] | |||||||||
Capital lease obligations | 7,150,611 | 7,150,611 | |||||||
Accumulated depreciation | 6,928 | 6,928 | |||||||
Computer and Office Equipment [Member] | |||||||||
Property, Plant and Equipment [Line Items] | |||||||||
Capitalized lease obligation | 95,880 | 95,880 | 95,880 | ||||||
Accumulated depreciation | $ 62,912 | $ 62,912 | $ 34,552 | ||||||
Operating Sublease [Member] | |||||||||
Property, Plant and Equipment [Line Items] | |||||||||
Lessee operating Lease, term of contract | 108 years | 108 years | 108 years | 108 years | 108 years | 5 years | |||
Payment of operating lease base rent | $ 6,615,000 | £ 5,250,000 | |||||||
Lessee operating Lease, additional term of lease | 5 years | ||||||||
Capital lease obligations | $ 7,150,611 | $ 7,150,611 | £ 5,613,165 | ||||||
Capital lease assets amortization period | 25 years | 25 years | 25 years | ||||||
Exchange rate | 1.2600 | 1.2600 | 1.2739 | 1.2739 | 1.2739 | ||||
Asset retirement obligations, noncurrent | $ 306,400 | ||||||||
Asset retirement obligations, discounted rate | 8.00% | ||||||||
Asset retirement obligation remeasurement period | 8 years | ||||||||
Operating Sublease [Member] | Leasehold Improvements [Member] | |||||||||
Property, Plant and Equipment [Line Items] | |||||||||
Asset retirement obligation | $ 205,659 | ||||||||
Asset retirement obligation recorded in leasehold improvements | $ (99,090) | $ (75,011) |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Other Noncurrent Liabilities [Member] | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash | $ 123,376 | $ 123,376 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Compensation and Benefits | $ 5,731,438 | $ 2,386,903 |
Clinical Trial Costs | 4,013,094 | 4,859,410 |
Professional Fees | 914,540 | 231,923 |
Consulting | 821,009 | 1,220,477 |
Research and Development | 236,271 | 73,379 |
Rent | 122,770 | 387,267 |
Interest | 40,800 | 33,437 |
Other | 111,775 | 140,148 |
Accrued expenses | $ 11,991,697 | $ 9,332,944 |
Capitalized Leases - Additional
Capitalized Leases - Additional Information (Detail) | Dec. 14, 2018 | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2018GBP (£) | Feb. 29, 2016 |
Operating Sublease [Member] | ||||||
Lessee operating Lease, renewal term | 108 years | 108 years | 108 years | 5 years | ||
Capitalized lease, leasehold percentage | 75.00% | |||||
Capital lease assets amortization period | 25 years | 25 years | ||||
Capital lease obligations | $ 7,150,611 | £ 5,613,165 | ||||
Office Equipment [Member] | ||||||
Assets acquired | $ 78,063 | $ 17,817 | ||||
Lease arrangement period | 3 years | 3 years | ||||
Capital lease amount | $ 86,145 | $ 20,502 | ||||
Capital lease interest rate | 6.90% | 9.35% |
Capitalized Leases - Schedule o
Capitalized Leases - Schedule of Future Minimum Lease Payments (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Leases [Abstract] | ||
2019 | $ 28,715 | |
2020 | 7,179 | |
Total minimum lease payments | 35,894 | |
Less: amount representing interest | (1,598) | |
Present value of net minimum lease payments | 34,296 | |
Less: current portion | (27,199) | $ (30,850) |
Obligations under capital lease, less current portion | 7,097 | $ 34,298 |
Present value of net minimum lease payments | $ 34,296 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Oct. 26, 2017 | |
Debt Disclosure [Abstract] | ||||
Promissory note issued | $ 1,442,009 | |||
Promissory note rate of interest | 5.00% | |||
Promissory note expiration due date | Dec. 31, 2018 | |||
Repayment of promissory note | $ 1,472,433 | |||
Interest expense | $ 33,429 | $ 42,863 |
Collaboration Agreement - Addit
Collaboration Agreement - Additional Information (Detail) - Janssen Pharmaceuticals Inc [Member] - Collaboration Agreement [Member] | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Deferred research funding | $ 658,667 |
Deferred research funding, amortization period | 8 months |
Research and Development Expenses [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Amortized of deferred research funding | $ 224,576 |
Other Current Liabilities [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Deferred research funding | $ 434,091 |
Share based Compensation - Addi
Share based Compensation - Additional Information (Detail) - USD ($) | Jun. 07, 2018 | Mar. 01, 2018 | Dec. 31, 2018 | 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 | 9 years 2 months 26 days | 9 years 1 month 2 days | |||
Fair value of options Vested | $ 1,387,607 | $ 898,699 | |||
Share options granted during the period | 2,334,285 | 611,933 | |||
Fully-diluted outstanding shares | 5.00% | ||||
Share based compensation | $ 17,883,554 | $ 2,959,731 | |||
Excess Tax Benefit from Share-based Compensation, Operating Activities | 0 | 0 | |||
Excess Tax Benefit from Share-based Compensation, Financing Activities | $ 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 | ||||
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 | |||
Ordinary shares [Member] | General and Administrative Expense [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share based compensation | $ 3,096,104 | ||||
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 | $ 20,141,876 | ||||
Restricted Shares [Member] | General and Administrative Expense [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share based compensation | $ 10,156,868 | ||||
Restricted Shares [Member] | 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 | 2,334,285 | 611,933 | |||
Total unvested options compensation expense | $ 17,415,098 | $ 987,413 | |||
Unvested options expected to be realized | 4 years | 3 years 5 months 1 day | |||
Weighted average grant date fair value of options granted | $ 6.53 | $ 3.10 | |||
Consultant [Member] | Restricted Shares [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Ordinary shares awarded, per share | 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 | ||||
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 ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Number of options, Beginning balance | 938,637 | 333,660 |
Number of options, Granted | 2,334,285 | 611,933 |
Number of options, Exercised | 1,288 | |
Number of options, Expired | 0 | 0 |
Number of options, Forfeited | (10,557) | (5,668) |
Number of options, Ending balance | 3,262,365 | 938,637 |
Weighted- average exercise price, beginning balance | $ 5.12 | $ 7.72 |
Weighted average remaining contractual life of options outstanding | 9 years 2 months 26 days | 9 years 1 month 2 days |
Weighted- average exercise price, granted | $ 8.63 | $ 3.73 |
Number of options, Options exercisable | 535,241 | 186,394 |
Weighted- average exercise price, exercised | $ 7.57 | |
Weighted average remaining contractual life of options Exercisable | 7 years 10 months 17 days | 8 years 2 months 15 days |
Weighted- average exercise price, expired | $ 0 | $ 0 |
Weighted- average exercise price, forfeited | (5.51) | (7.72) |
Weighted- average exercise price, ending balance | 7.64 | 5.12 |
Weighted- average exercise price, option Exercisable | $ 5.79 | $ 7.72 |
Aggregate Intrinsic Value | $ 6,903,313 | |
Aggregate Intrinsic Value, Options Exercisable | $ 0 | $ 0 |
Share Based Compensation - Sche
Share Based Compensation - Schedule of Grant Date Fair Values of the Stock Option Granted Black Scholes Valuation Model (Detail) - Employee and Non Employee Board of Directors [Member] | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.32% | 2.28% |
Risk-free interest rate | 2.98% | 2.51% |
Expected volatility | 90.00% | 80.00% |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life of non-employee options (in years) | 5 years 6 months | 5 years 6 months |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life of non-employee options (in years) | 10 years | 10 years |
Share Based Compensation - Su_2
Share Based Compensation - Summary of Restricted Ordinary Shares (Detail) - Restricted Shares [Member] - USD ($) | Jun. 07, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-vested Ordinary Shares, Beginning Balance | 105,913 | 386,608 | |
Issued, Ordinary Shares | 1,306,348 | 1,306,348 | |
Issued, Value | $ 19,595,220 | ||
Vesting, Ordinary Shares | (759,087) | (280,695) | |
Non-vested Ordinary Shares, Ending Balance | 653,174 | 105,913 | |
Non-vested Value, Beginning Balance | $ 865,861 | $ 3,020,191 | |
Vesting, Value | (10,663,471) | (2,154,330) | |
Non-vested Value, Ending Balance | $ 9,797,610 | $ 865,861 |
Share Based Compensation - Sc_2
Share Based Compensation - Schedule of Share Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Expense [Line Items] | ||
Total share based compensation | $ 17,883,554 | $ 2,959,731 |
Research and Development Expenses [Member] | ||
Share Based Compensation Expense [Line Items] | ||
Total share based compensation | 3,372,054 | 2,374,899 |
General and Administrative Expense [Member] | ||
Share Based Compensation Expense [Line Items] | ||
Total share based compensation | $ 14,511,500 | $ 584,832 |
Ordinary Shares, Convertible _2
Ordinary Shares, Convertible Preferred C Shares and Shareholders' Deficit - Additional Information (Detail) - USD ($) | Oct. 05, 2018 | Jun. 07, 2018 | Jun. 05, 2018 | Mar. 15, 2018 | Mar. 01, 2018 | Nov. 02, 2017 | Sep. 21, 2017 | Aug. 16, 2017 | Jul. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2015 |
Percentage of fully diluted shares | 5.00% | |||||||||||
Stock issued during period, shares, stock options exercised | 1,288 | |||||||||||
Gross proceeds from preferred shares | $ 56,849,594 | $ 16,854,653 | ||||||||||
Conversion of note payable into convertible preferred C shares, shares | 238,579 | |||||||||||
Preferred share conversion value | $ 664,718 | 1,806,512 | 191,963 | |||||||||
Conversion of note payable into convertible preferred C shares | $ 2,500,000 | $ 120,520,391 | ||||||||||
Preferred shares, purchase | 927,594 | 695,696 | ||||||||||
Preferred shares, exercise price | $ 10.48 | $ 10.48 | $ 2.70 | |||||||||
Accretion of warrants issued in connection with convertible preferred shares | $ 1,660,500 | $ (1,045,500) | (615,000) | |||||||||
Convertible note inducement expense | 553,500 | |||||||||||
Change in fair value of warrant liability | 1,514,775 | 465,633 | ||||||||||
Warrant liability | $ 4,194,408 | $ 2,679,633 | ||||||||||
Preferred shares, value | $ 9,720,000 | $ 9,720,000 | ||||||||||
Vector Neurosciences Inc [Member] | ||||||||||||
Number of shares issued as initial merger consideration | 225,000 | |||||||||||
Period of shares issued as initial merger consideration | 18 months | |||||||||||
Vector Neurosciences Inc [Member] | Issued at Closing of Merger [Member] | ||||||||||||
Number of shares issued as initial merger consideration | 202,500 | |||||||||||
Vector Neurosciences Inc [Member] | Issued Following Closing of Merger [Member] | ||||||||||||
Number of shares issued as initial merger consideration | 22,500 | |||||||||||
Restricted Shares [Member] | ||||||||||||
Ordinary shares, offering price | $ 15 | |||||||||||
Ordinary shares | 1,306,348 | 1,306,348 | ||||||||||
Percentage of fully diluted shares | 5.00% | |||||||||||
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 | $ 9,807,622 | $ 4,115,843 | ||||||||||
Percentage of fully diluted shares | 3.00% | |||||||||||
Stock issued during period, shares, stock options exercised | 1,288 | 1,288 | ||||||||||
Conversion of note payable into convertible preferred C shares, shares | 11,501,432 | 11,501,432 | ||||||||||
Conversion of note payable into convertible preferred C shares | $ 446 | |||||||||||
Ordinary shares [Member] | Research Agreement [Member] | ||||||||||||
Ordinary shares, issued | 6,441 | |||||||||||
Ordinary shares [Member] | Restricted Shares [Member] | ||||||||||||
Ordinary shares | 867,935 | |||||||||||
Preferred Shares [Member] | ||||||||||||
Ordinary shares, issued | 715,737 | 5,425,124 | ||||||||||
Ordinary shares, offering price | $ 10.48 | $ 10.48 | ||||||||||
Offering costs | $ 690,473 | $ 98,804 | ||||||||||
Gross proceeds from preferred shares | 56,849,611 | $ 16,854,656 | ||||||||||
Conversion of note payable into convertible preferred C shares, shares | 238,579 | |||||||||||
Conversion rate of note payable into convertible preferred shares | 10.48 | |||||||||||
Preferred Shares [Member] | Issued at Closing of Merger [Member] | ||||||||||||
Ordinary shares, issued | 9,739 | |||||||||||
Ordinary shares, offering price | $ 20.96 | |||||||||||
Preferred Shares [Member] | Issued Following Closing of Merger [Member] | ||||||||||||
Ordinary shares, issued | 1,598,418 | |||||||||||
Ordinary shares, offering price | $ 10.48 | |||||||||||
Convertible Preferred C Shares [Member] | ||||||||||||
Offering costs | $ 690,475 | |||||||||||
Conversion of note payable into convertible preferred C shares, shares | (11,501,432) | 238,579 | ||||||||||
Conversion of note payable into convertible preferred C shares | $ (120,520,391) | $ 2,500,000 | ||||||||||
Preferred shares, purchase | 927,594 | |||||||||||
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 | $ 1,355,097 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Basic and Diluted Net Loss per Share (Detail) - USD ($) | Jun. 07, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Earnings Per Share [Abstract] | |||
Net loss-basic and diluted | $ (82,865,874) | $ (31,044,535) | |
Accretion of Preferred Shares financing costs | $ (664,718) | (1,806,512) | (191,963) |
Accretion of warrant | (615,000) | ||
Adjusted net loss-basic and diluted | $ (84,672,386) | $ (31,851,498) | |
Weighted-average ordinary shares outstanding: | |||
Basic and Diluted | 18,948,520 | 8,572,315 | |
Net loss per share: | |||
Basic and Diluted | $ (4.47) | $ (3.72) |
Net Loss per Share - Schedule_2
Net Loss per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings per Share (Detail) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 3,915,539 | 6,978,078 |
Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 5,005,934 | |
Restricted Shares [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 653,174 | 105,913 |
Stock Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 3,262,365 | 938,637 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earning per share, amount | 927,594 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | Apr. 01, 2020 | Apr. 01, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Income Taxes Disclosure [Line Items] | ||||
Income tax expense (benefit) | $ (474,391) | $ 0 | ||
Federal net operating loss carryforwards | 14,210,000 | 6,800,000 | ||
State net operating loss carryforwards | 14,155,000 | $ 6,700,000 | ||
Foreign net operating loss carryforwards | $ 94,100,000 | |||
Income tax operating loss carryforward expiration date | 2036 | 2036 | ||
Deferred tax assets, tax credit carryforwards, orphan drug and research and development | $ 1,133,656 | $ 697,406 | ||
Deferred tax assets, tax credit carryforwards, expiration year | 2036 | |||
Provision for valuation allowance | $ 0 | |||
Foreign currency translation, tax | $ 474,391 | $ 0 | ||
Foreign tax rate differential | 17.00% | |||
Foreign tax rate differential | 19.00% | 0.21% | 2.17% | |
Effective income tax rate reconciliation, at federal statutory Income tax rate, percent | 19.00% | 19.25% | ||
Decrease in the prior years deferred tax assets | $ 994,000 | |||
Federal [Member] | ||||
Income Taxes Disclosure [Line Items] | ||||
Deferred tax assets, tax credit carryforwards, orphan drug and research and development | $ 1,133,656 | $ 697,406 | ||
Effective income tax rate reconciliation, at federal statutory Income tax rate, percent | 21.00% | 34.00% | ||
Scenario, Forecast [Member] | ||||
Income Taxes Disclosure [Line Items] | ||||
Foreign tax rate differential | 17.00% | |||
Foreign tax rate differential | 18.00% |
Income Taxes - Summary of Compa
Income Taxes - Summary of Company's Pre Tax Earnings (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Before Income Taxes [Line Items] | ||
Total | $ (82,865,874) | $ (31,044,535) |
U.K. [Member] | ||
Income Before Income Taxes [Line Items] | ||
Total | (73,359,977) | (26,458,625) |
Federal [Member] | ||
Income Before Income Taxes [Line Items] | ||
Total | $ (9,980,287) | $ (4,585,910) |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Income Tax Benefit with Amounts at the U.K. Statutory Income Tax Rate (Detail) - USD ($) | Apr. 01, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | |||
Statutory rate | $ (15,834,650) | $ (5,976,073) | |
Permanent differences-other | 1,438,934 | 654,648 | |
RTP and other adjustments | 387,509 | (152,948) | |
U.K. tax credit | 1,707,489 | 539,136 | |
U.S. tax credit | (436,250) | (363,665) | |
Foreign tax rate differential | (171,693) | (673,619) | |
State and local rate, net of federal tax | (1,159,522) | (446,683) | |
UK Rate Change (17% at expected DTA turn) | 1,104,863 | 482,351 | |
U.S. state rate change | (6,496) | 993,998 | |
Change in valuation allowance | 12,495,426 | 4,942,855 | |
Actual income tax benefit effective tax rate | $ (474,391) | $ 0 | |
Statutory rate | 19.00% | 19.25% | |
Permanent differences-other | (1.73%) | (2.11%) | |
RTP and other adjustments | (0.46%) | 0.49% | |
U.K. tax credit | (2.05%) | (1.74%) | |
U.S. tax credit | 0.52% | 1.17% | |
Foreign tax rate differential | 19.00% | 0.21% | 2.17% |
State and local rate, net of federal tax | 1.39% | 1.44% | |
UK Rate Change (17% at expected DTA turn) | (1.33%) | (1.55%) | |
U.S. state rate change | 0.01% | (3.20%) | |
Change in valuation allowance | (14.99%) | (15.92%) | |
Actual income tax benefit effective tax rate | 0.57% | 0.00% |
Income Taxes - Schedule of Expe
Income Taxes - Schedule of Expense/(Benefit) for Income Taxes from Continuing Operations (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Current Tax Expense/(Benefit) | ||
United Kingdom | $ 0 | $ 0 |
United States | 0 | 0 |
Total Current | 0 | 0 |
Deferred Tax Expense/(Benefit) | ||
United Kingdom | (8,888,096) | (3,759,109) |
United States | (3,606,275) | (1,183,746) |
Total Deferred | (12,494,371) | (4,942,855) |
Change in valuation allowance | 12,495,426 | 4,942,855 |
Actual income tax benefit effective tax rate | $ (474,391) | $ 0 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred Tax Assets: | ||
Net operating loss carryforwards | $ 20,646,185 | $ 9,462,690 |
Other | 1,414,690 | 539,008 |
Tax Credit | 1,133,656 | 697,406 |
Deferred tax assets | 23,194,531 | 10,699,105 |
Less: valuation allowance | (23,194,531) | (10,699,105) |
Net deferred tax asset | 0 | 0 |
U.K. [Member] | ||
Deferred Tax Assets: | ||
Net operating loss carryforwards | 16,000,329 | 6,909,754 |
Other | (46,604) | 152,554 |
Deferred tax assets | 15,953,725 | 7,062,308 |
Less: valuation allowance | (15,953,725) | (7,062,308) |
Net deferred tax asset | 0 | 0 |
Federal [Member] | ||
Deferred Tax Assets: | ||
Net operating loss carryforwards | 4,645,856 | 2,552,937 |
Other | 1,461,294 | 386,454 |
Tax Credit | 1,133,656 | 697,406 |
Deferred tax assets | 7,240,806 | 3,636,797 |
Less: valuation allowance | (7,240,806) | (3,636,797) |
Net deferred tax asset | $ 0 | $ 0 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) | Nov. 02, 2017USD ($)$ / sharesshares | May 01, 2017USD ($) | Apr. 24, 2015 | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($) | Dec. 31, 2017GBP (£) | Oct. 31, 2020USD ($) | Oct. 31, 2020GBP (£) | Jun. 05, 2018$ / shares | Oct. 26, 2017USD ($) | Sep. 21, 2017$ / shares |
Related Party Transaction [Line Items] | ||||||||||||
Amount due under services agreement | $ 0 | $ 861,030 | ||||||||||
Related party transaction amounts of work orders issued | 570,525 | 593,933 | ||||||||||
Research and development expenses | 33,620,223 | 22,359,712 | ||||||||||
Aggregate future minimum rental payments under operating lease | $ 4,615,675 | |||||||||||
Promissory note issued | $ 1,442,009 | |||||||||||
Convertible notes payable, interest rate | 10.00% | |||||||||||
Conversion of note payable into convertible preferred shares | shares | 238,579 | |||||||||||
Conversion rate of note payable into convertible preferred shares | $ / shares | $ 2.70 | |||||||||||
Accrued interest cancelled | $ 145,833 | |||||||||||
Warrant to purchase preferred shares | shares | 900,000 | |||||||||||
Warrant exercise price | $ / shares | $ 2.70 | $ 10.48 | $ 10.48 | |||||||||
ARE [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Note payable to related party, amount | $ 2,500,000 | |||||||||||
Transition Services Agreement with Related Party [Member] | Kadmon [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Percentage of administrative fees | 7.00% | |||||||||||
Services termination date | Apr. 24, 2018 | |||||||||||
Ownership percentage by related party | 12.90% | |||||||||||
Cash payment | $ 1,431,555 | 275,941 | ||||||||||
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 | $ 201,264 | 231,276 | ||||||||||
Operating lease rent expenses | 487,555 | 487,559 | ||||||||||
Aggregate future minimum rental payments under operating lease | 1,663,952 | |||||||||||
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 rent expenses | $ 0 | 1,660,806 | ||||||||||
Operating lease termination date | Mar. 31, 2018 | |||||||||||
Base rent and management fees | $ 563,507 | |||||||||||
Promissory note issued | $ 1,442,009 | |||||||||||
UCL Consultants Limited [Member] | Research Agreement [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Amount due under services agreement | $ 389,101 | 775,315 | ||||||||||
Related party transaction amounts of work orders issued | 1,885,000 | £ 1,402,202 | ||||||||||
Agreement termination notice period | 30 days | |||||||||||
Research and development expenses | $ 636,000 | 538,000 | ||||||||||
UCL Consultants Limited [Member] | Manufacturing Agreement [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Amount due under services agreement | 0 | 2,466,142 | ||||||||||
Research and development expenses | $ 0 | $ 1,904,352 | ||||||||||
Agreement termination date | 2018-01 | |||||||||||
UCL Consultants Limited [Member] | Scenario, Forecast [Member] | Research Agreement [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Future obligations under agreement | $ 779,685 | £ 612,382 |
Related Party Transactions - In
Related Party Transactions - Incurred Charges included in Loss from Operations (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Related Party Transaction [Line Items] | ||
Total charges incurred | $ 570,525 | $ 593,933 |
Rent [Member] | ||
Related Party Transaction [Line Items] | ||
Total charges incurred | 557,698 | 548,229 |
Personnel [Member] | ||
Related Party Transaction [Line Items] | ||
Total charges incurred | 6,493 | 39,721 |
Other [Member] | ||
Related Party Transaction [Line Items] | ||
Total charges incurred | $ 6,334 | $ 5,983 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) | Mar. 25, 2021USD ($) | Jul. 27, 2018USD ($)Lease | Jun. 07, 2018$ / sharesshares | Mar. 01, 2018 | Aug. 24, 2017USD ($) | Dec. 05, 2016USD ($)shares | Mar. 22, 2016USD ($) | Sep. 28, 2015$ / sharesshares | Apr. 24, 2015$ / sharesshares | Feb. 04, 2015EUR (€)Program | Feb. 04, 2015USD ($)Program | Dec. 31, 2018EUR (€) | Apr. 30, 2017USD ($) | Feb. 14, 2017USD ($) | Dec. 31, 2018EUR (€)Leaseshares | Dec. 31, 2018USD ($)Leaseshares | Jan. 31, 2018USD ($) | Dec. 31, 2017EUR (€)shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2015 | Dec. 05, 2019USD ($) | Dec. 31, 2018USD ($) | Oct. 01, 2017 | Jan. 01, 2016USD ($) |
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | $ 33,620,223 | $ 22,359,712 | ||||||||||||||||||||||
General and administrative expense | $ 44,483,938 | $ 9,325,017 | ||||||||||||||||||||||
Ordinary share | shares | 2,334,285 | 2,334,285 | 611,933 | 611,933 | ||||||||||||||||||||
Service Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Employees aggregate compensation | € | € 300,000 | |||||||||||||||||||||||
Research and development expenses | 1,001,000 | $ 1,334,000 | € 724,000 | $ 933,000 | ||||||||||||||||||||
Future obligations under agreement | € 150,333 | € 150,333 | $ 192,000 | |||||||||||||||||||||
Employment Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Employees aggregate compensation | $ 710,000 | |||||||||||||||||||||||
Future obligations under agreement | 1,258,750 | |||||||||||||||||||||||
Agreegate discretionary bonus | 3,415,000 | $ 1,196,000 | 850,000 | |||||||||||||||||||||
Employee agreement description | The employment agreements also provide for an annual guaranteed cash bonus targeted at 100% of annual compensation. The agreements also provide for discretionary annual performance bonuses targeted to be not less than 50-60% of the employee's base salary and grants of restricted stock. | |||||||||||||||||||||||
Employment agreement term | 3 years | |||||||||||||||||||||||
Percentage of fully-diluted outstanding shares | 5.00% | 3.00% | ||||||||||||||||||||||
Consulting And Other Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
General and administrative expense | 263,970 | 351,960 | ||||||||||||||||||||||
Research Agreement One [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | $ 418,000 | 418,000 | ||||||||||||||||||||||
Consulting agreement term | 5 years | |||||||||||||||||||||||
Quarterly payment received for Research and development agreement | $ 104,500 | |||||||||||||||||||||||
Restricted Shares [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Employees share award | shares | 1,306,348 | 1,306,348 | 1,306,348 | |||||||||||||||||||||
Employees share award, per share | $ / shares | $ 15 | |||||||||||||||||||||||
Ordinary shares forfeiture period | 3 years | |||||||||||||||||||||||
Restricted Shares [Member] | Service Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Employees share award | shares | 2,704,800 | |||||||||||||||||||||||
Employees share award, per share | $ / shares | $ 7.76 | |||||||||||||||||||||||
Ordinary shares forfeiture period | 3 years | |||||||||||||||||||||||
Restricted Shares [Member] | Consulting And Other Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Employees share award | shares | 662,910 | |||||||||||||||||||||||
Ordinary shares forfeiture period | 3 years | |||||||||||||||||||||||
Restricted Shares [Member] | Director [Member] | Consulting And Other Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Consulting agreement term | 3 years | |||||||||||||||||||||||
Maximum [Member] | Service Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Employees aggregate compensation | € 410,000 | $ 522,000 | ||||||||||||||||||||||
Maximum [Member] | Employment Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Employees aggregate compensation | $ 1,075,000 | |||||||||||||||||||||||
Percentage of fully-diluted outstanding shares | 8.00% | 8.00% | ||||||||||||||||||||||
General and Administrative Expense [Member] | Restricted Shares [Member] | Consulting And Other Agreements [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Employees share award, per share | $ / shares | $ 7.72 | |||||||||||||||||||||||
U.S. Department Of Health And Human Services [Member] | Research Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | $ 111,938 | 115,374 | ||||||||||||||||||||||
Quarterly payment received for Research and development agreement | $ 21,250 | |||||||||||||||||||||||
Agreement amended date | Mar. 25, 2016 | |||||||||||||||||||||||
Agreement expiration date | Apr. 30, 2017 | |||||||||||||||||||||||
Research agreement payment received period | 3 years | |||||||||||||||||||||||
Cornell University [Member] | Research Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | 143,073 | 698,307 | ||||||||||||||||||||||
Agreement amended date | Jun. 12, 2017 | |||||||||||||||||||||||
Research and collaboration agreement period | 3 years | |||||||||||||||||||||||
Ordinary share | shares | 25,000 | |||||||||||||||||||||||
Research and collaboration agreement period | 1 year | |||||||||||||||||||||||
Research and collaboration agreement amount | $ 679,473 | |||||||||||||||||||||||
Cornell University [Member] | Issued at Closing of Merger [Member] | Research Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | $ 17,000 | 1,625,152 | 1,029,904 | |||||||||||||||||||||
Cornell University [Member] | Issued Following Closing of Merger [Member] | Research Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development amended agreement amount | $ 182,520 | |||||||||||||||||||||||
National Institutes of Health [Member] | License Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | 50,000 | 0 | ||||||||||||||||||||||
BRI-Alzan [Member] | License Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | 15,000 | 30,000 | ||||||||||||||||||||||
Sales milestone payments | $ 4,500,000 | |||||||||||||||||||||||
Scenario, Forecast [Member] | U.S. Department Of Health And Human Services [Member] | Research Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Future obligations under agreement | $ 191,250 | |||||||||||||||||||||||
Agreement expiration date | Mar. 25, 2021 | |||||||||||||||||||||||
Scenario, Forecast [Member] | Cornell University [Member] | Research Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Future obligations under agreement | $ 2,002,228 | |||||||||||||||||||||||
License Agreements Effective February 4, 2015 [Member] | UCL Business, PLC [Member] | License Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | 75,073 | 73,250 | ||||||||||||||||||||||
Number of collaborations programs | Program | 8 | 8 | ||||||||||||||||||||||
Sales milestone payments | € 39,800,000 | 50,700,000 | ||||||||||||||||||||||
Maintenance fee | € 50,000 | $ 64,000 | ||||||||||||||||||||||
License Agreement Effective July 28, 2017 [Member] | UCL Business, PLC [Member] | License Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | 66,630 | 82,260 | ||||||||||||||||||||||
License Agreements Effective March 15, 2018 [Member] | UCL Business, PLC [Member] | License Agreement [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Research and development expenses | 133,728 | 0 | ||||||||||||||||||||||
July 27, 2018 Lease [Member] | London UK [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Operating lease rent expense | 148,561 | 0 | ||||||||||||||||||||||
Annual base rent | $ 363,000 | |||||||||||||||||||||||
Operating lease termination date | May 24, 2027 | |||||||||||||||||||||||
Number of leases expired | Lease | 2 | |||||||||||||||||||||||
Number of new leases | Lease | 2 | |||||||||||||||||||||||
February,2016 Lease [Member] | London UK [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Operating lease expiration | 2021-02 | |||||||||||||||||||||||
Operating lease rent expense | $ 273,430 | 279,303 | ||||||||||||||||||||||
October 1,2017 Lease [Member] | Leiden Netherland [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Operating lease expiration | 2018-09 | 2018-09 | ||||||||||||||||||||||
Operating lease rent expense | $ 9,313 | 5,273 | ||||||||||||||||||||||
Term of non-cancellable operating lease | 1 year | 1 year | ||||||||||||||||||||||
October 1,2017 Lease [Member] | Leiden Netherland [Member] | Minimum [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Operating lease, renewal Term | 1 year | |||||||||||||||||||||||
October 1,2017 Lease [Member] | Leiden Netherland [Member] | Maximum [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Operating lease, renewal Term | 4 years | |||||||||||||||||||||||
June 2017 Lease [Member] | London UK [Member] | ||||||||||||||||||||||||
Other Commitments [Line Items] | ||||||||||||||||||||||||
Operating lease expiration | 2018-07 | 2018-07 | ||||||||||||||||||||||
Operating lease rent expense | $ 73,846 | $ 85,222 | ||||||||||||||||||||||
Deferred rent | $ 0 | |||||||||||||||||||||||
Operating leases rent expense payment description | The Company records monthly rent expense on a straight-line basis from June 1, 2017 through July 23, 2018. | The Company records monthly rent expense on a straight-line basis from June 1, 2017 through July 23, 2018. | ||||||||||||||||||||||
Number of non cancellable operating leases | Lease | 2 | 2 |
Commitments - Schedule of Futur
Commitments - Schedule of Future Minimum Rental Payments (Detail) - USD ($) | Dec. 31, 2018 | Jul. 27, 2018 |
Operating Leased Assets [Line Items] | ||
2019 | $ 889,465 | |
2020 | 904,716 | |
2021 | 924,121 | |
2022 | 350,284 | |
2023 | 350,284 | |
Thereafter | 1,196,805 | |
Total future rent payments | $ 4,615,675 | |
July 27, 2018 Lease [Member] | ||
Operating Leased Assets [Line Items] | ||
2019 | $ 353,782 | |
2020 | 350,284 | |
2021 | 350,284 | |
2022 | 350,284 | |
2023 | 350,284 | |
Thereafter | 1,196,805 | |
Total future rent payments | $ 2,951,723 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Detail) - USD ($) | May 01, 2019 | Apr. 30, 2019 | Jan. 01, 2017 | Aug. 01, 2016 | Dec. 31, 2018 | Dec. 31, 2017 |
United States | ||||||
Compensation And Retirement Disclosure [Line Items] | ||||||
Defined contribution plan, annual contributions per employee, percent | 6.00% | |||||
United States | Minimum [Member] | ||||||
Compensation And Retirement Disclosure [Line Items] | ||||||
Defined contribution plan employee eligibility age | 21 years | |||||
United Kingdom [Member] | ||||||
Compensation And Retirement Disclosure [Line Items] | ||||||
Defined benefit plan, plan assets, contributions by employer | $ 440,368 | $ 252,700 | ||||
United Kingdom [Member] | Minimum [Member] | ||||||
Compensation And Retirement Disclosure [Line Items] | ||||||
Defined contribution plan, employer matching contribution, percent | 7.50% | |||||
United Kingdom [Member] | Maximum [Member] | ||||||
Compensation And Retirement Disclosure [Line Items] | ||||||
Defined contribution plan, employer matching contribution, percent | 10.00% | |||||
United Kingdom [Member] | Scenario, Forecast [Member] | Minimum [Member] | ||||||
Compensation And Retirement Disclosure [Line Items] | ||||||
Defined contribution plan, employer matching contribution, percent | 8.00% | 5.00% | ||||
United Kingdom [Member] | Scenario, Forecast [Member] | Maximum [Member] | ||||||
Compensation And Retirement Disclosure [Line Items] | ||||||
Defined contribution plan, employer matching contribution, percent | 9.00% | 6.00% |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) | Jul. 31, 2019 | Jan. 30, 2019USD ($) | Jan. 29, 2019USD ($)shares | Jan. 29, 2019GBP (£)shares | Feb. 27, 2018USD ($)shares | Dec. 31, 2018shares | Dec. 31, 2017shares |
Subsequent Event [Line Items] | |||||||
Common stock, shares issued | shares | 27,386,632 | 8,826,190 | |||||
Private Placement [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Common stock, shares issued | shares | 5,797,102 | ||||||
Proceeds from issuance of private placement | $ | $ 80,000,000 | ||||||
Offering costs | $ | $ 2,600,000 | ||||||
JJDC [Member] | Private Placement [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Common stock, shares issued | shares | 2,898,550 | ||||||
Subsequent Event [Member] | Private Placement [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Registration Payment Arrangement Liquidated Damages Percent | 1.00% | ||||||
Subsequent Event [Member] | License Agreement [Member] | |||||||
Subsequent Event [Line Items] | |||||||
License agreement amendment description | On January 29, 2019, the Company amended and restated the following agreements: (i) the License Agreement, dated February 4, 2015, as amended, between the Company and UCL Business, Plc (“UCLB”); (ii) the License Agreement, dated July 28, 2017, as amended, between the Company and UCLB; and (iii) the License Agreement, dated March 15, 2018, between the Company and UCLB to establish new stand-alone license agreements for the following inherited retinal disease programs: (a) achromatopsia (“ACHM”) caused by mutations in CNGB3; (b) ACHM caused by mutations in CNGA3; (c) X-linked retinitis pigmentosa (“XLRP”); and (d) RPE65-mediated IRD. | On January 29, 2019, the Company amended and restated the following agreements: (i) the License Agreement, dated February 4, 2015, as amended, between the Company and UCL Business, Plc (“UCLB”); (ii) the License Agreement, dated July 28, 2017, as amended, between the Company and UCLB; and (iii) the License Agreement, dated March 15, 2018, between the Company and UCLB to establish new stand-alone license agreements for the following inherited retinal disease programs: (a) achromatopsia (“ACHM”) caused by mutations in CNGB3; (b) ACHM caused by mutations in CNGA3; (c) X-linked retinitis pigmentosa (“XLRP”); and (d) RPE65-mediated IRD. | |||||
License arrangement upfront payment | $ 1,976,000 | £ 1,500,000 | |||||
Common stock, shares issued | shares | 1,500,000 | 1,500,000 | |||||
Subsequent Event [Member] | Collaboration Agreement [Member] | Janssen Pharmaceuticals Inc [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Upfront payment | $ | $ 100,000,000 | ||||||
Commercial milestone payments | $ | $ 340,000,000 | ||||||
Subsequent Event [Member] | Clinical Collaborative Arrangement [Member] | Janssen Pharmaceuticals Inc [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Percentage of royalties payable on annual net sales of licensed product statement | 20.00% | ||||||
Percentage of costs payable on annual net sales of licensed product statement | 100.00% |