Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Entity File Number | 001-38520 | |
Entity Registrant Name | MeiraGTx Holdings plc | |
Entity Incorporation, State or Country Code | E9 | |
Entity Tax Identification Number | 98-1448305 | |
Entity Address, Address Line One | 450 East 29th Street | |
Entity Address, Address Line Two | 14th Floor | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10016 | |
City Area Code | 646 | |
Local Phone Number | 860-7985 | |
Title of 12(b) Security | Ordinary Shares,$0.00003881 par value per share | |
Trading Symbol | MGTX | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Common Stock, Shares Outstanding | 63,597,151 | |
Entity Central Index Key | 0001735438 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 63,365 | $ 115,516 |
Accounts receivable - related party | 22,398 | 21,334 |
Prepaid expenses | 6,997 | 8,133 |
Tax incentive receivable | 10,013 | 7,689 |
Other current assets | 758 | 1,667 |
Total Current Assets | 103,531 | 154,339 |
Property, plant and equipment, net | 111,880 | 109,266 |
Intangible assets, net | 1,140 | 1,335 |
In-process research and development | 732 | 742 |
Restricted cash | 1,038 | |
Other assets | 1,421 | 1,402 |
Equity method and other investments | 6,326 | 6,326 |
Right-of-use assets - operating leases, net | 17,446 | 20,109 |
Right-of-use assets - finance leases, net | 23,680 | 24,718 |
TOTAL ASSETS | 267,194 | 318,237 |
CURRENT LIABILITIES: | ||
Accounts payable | 20,773 | 16,616 |
Accrued expenses | 28,251 | 39,818 |
Lease obligations, current | 4,092 | 3,884 |
Deferred revenue - related party, current | 7,922 | 15,123 |
Other current liabilities | 2,476 | 6,631 |
Total Current Liabilities | 63,514 | 82,072 |
Deferred revenue - related party | 23,191 | 27,436 |
Lease obligations | 14,256 | 17,331 |
Asset retirement obligations | 2,319 | 2,179 |
Deferred income tax liability | 184 | 186 |
Note payable, net | 71,844 | 71,033 |
Other long-term liabilities | 262 | |
TOTAL LIABILITIES | 175,308 | 200,499 |
SHAREHOLDERS' EQUITY: | ||
Ordinary Shares, $0.00003881 par value, 1,288,327,750 authorized, 59,597,151 and 48,477,209 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 2 | 2 |
Capital in excess of par value | 659,170 | 581,893 |
Accumulated other comprehensive income | 7,160 | 6,047 |
Accumulated deficit | (574,446) | (470,204) |
Total Shareholders' Equity | 91,886 | 117,738 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 267,194 | $ 318,237 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Common stock, par value | $ 0.00003881 | $ 0.00003881 |
Common stock, shares authorized | 1,288,327,750 | 1,288,327,750 |
Common stock, shares issued | 59,597,151 | 48,477,209 |
Common stock, shares outstanding | 59,597,151 | 48,477,209 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
License revenue - related party | $ 5,103 | $ 4,816 | $ 11,977 | $ 21,208 |
Operating expenses: | ||||
General and administrative | 10,009 | 10,762 | 35,169 | 32,548 |
Research and development | 27,856 | 16,862 | 70,115 | 63,960 |
Total operating expenses | 37,865 | 27,624 | 105,284 | 96,508 |
Loss from operations | (32,762) | (22,808) | (93,307) | (75,300) |
Other non-operating income (expense): | ||||
Foreign currency loss | (8,677) | (12,838) | (2,915) | (25,911) |
Interest income | 523 | 288 | 1,723 | 345 |
Interest expense | (3,381) | (1,892) | (9,796) | (2,051) |
Fair value adjustments | (34) | 53 | 615 | |
Net loss | (44,297) | (37,284) | (104,242) | (102,302) |
Other comprehensive income (loss): | ||||
Foreign currency translation gain | 6,007 | 8,772 | 1,113 | 18,062 |
Total comprehensive loss | (38,290) | (28,512) | (103,129) | (84,240) |
Net loss | $ (44,297) | $ (37,284) | $ (104,242) | $ (102,302) |
Basic net loss per ordinary share | $ (0.74) | $ (0.83) | $ (1.91) | $ (2.29) |
Diluted net loss per ordinary share | $ (0.74) | $ (0.83) | $ (1.91) | $ (2.29) |
Weighted-average number of ordinary shares outstanding, basic | 59,526,642 | 44,687,635 | 54,544,660 | 44,620,900 |
Weighted-average number of ordinary shares outstanding, diluted | 59,526,642 | 44,687,635 | 54,544,660 | 44,620,900 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Ordinary Shares | Capital in Excess of Par Value | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2021 | $ 2 | $ 528,659 | $ (2,671) | $ (340,589) | $ 185,401 |
Beginning Balance (shares) at Dec. 31, 2021 | 44,548,925 | ||||
Share based compensation activity | 4,996 | 4,996 | |||
Share based compensation activity (shares) | 161,753 | ||||
Other comprehensive income (loss) | 1,933 | 1,933 | |||
Net loss | (31,045) | (31,045) | |||
Balance at Mar. 31, 2022 | $ 2 | 533,655 | (738) | (371,634) | 161,285 |
Balance (shares) at Mar. 31, 2022 | 44,710,678 | ||||
Beginning Balance at Dec. 31, 2021 | $ 2 | 528,659 | (2,671) | (340,589) | 185,401 |
Beginning Balance (shares) at Dec. 31, 2021 | 44,548,925 | ||||
Other comprehensive income (loss) | 18,062 | ||||
Net loss | (102,302) | ||||
Balance at Sep. 30, 2022 | $ 2 | 550,168 | 15,391 | (442,891) | 122,670 |
Balance (shares) at Sep. 30, 2022 | 44,725,678 | ||||
Beginning Balance at Mar. 31, 2022 | $ 2 | 533,655 | (738) | (371,634) | 161,285 |
Beginning Balance (shares) at Mar. 31, 2022 | 44,710,678 | ||||
Share based compensation activity | 7,303 | 7,303 | |||
Other comprehensive income (loss) | 7,357 | 7,357 | |||
Net loss | (33,973) | (33,973) | |||
Balance at Jun. 30, 2022 | $ 2 | 540,958 | 6,619 | (405,607) | 141,972 |
Balance (shares) at Jun. 30, 2022 | 44,710,678 | ||||
Share based compensation activity | 6,937 | 6,937 | |||
Share based compensation activity (shares) | 15,000 | ||||
Warrants issued in connection with note payable | 2,273 | 2,273 | |||
Other comprehensive income (loss) | 8,772 | 8,772 | |||
Net loss | (37,284) | (37,284) | |||
Balance at Sep. 30, 2022 | $ 2 | 550,168 | 15,391 | (442,891) | 122,670 |
Balance (shares) at Sep. 30, 2022 | 44,725,678 | ||||
Beginning Balance at Dec. 31, 2022 | $ 2 | 581,893 | 6,047 | (470,204) | 117,738 |
Beginning Balance (shares) at Dec. 31, 2022 | 48,477,209 | ||||
Share based compensation activity | 5,201 | 5,201 | |||
Share based compensation activity (shares) | 209,054 | ||||
Other comprehensive income (loss) | (2,353) | (2,353) | |||
Net loss | (30,364) | (30,364) | |||
Balance at Mar. 31, 2023 | $ 2 | 587,094 | 3,694 | (500,568) | 90,222 |
Balance (shares) at Mar. 31, 2023 | 48,686,263 | ||||
Beginning Balance at Dec. 31, 2022 | $ 2 | 581,893 | 6,047 | (470,204) | 117,738 |
Beginning Balance (shares) at Dec. 31, 2022 | 48,477,209 | ||||
Other comprehensive income (loss) | 1,113 | ||||
Net loss | (104,242) | ||||
Balance at Sep. 30, 2023 | $ 2 | 659,170 | 7,160 | (574,446) | 91,886 |
Balance (shares) at Sep. 30, 2023 | 59,597,151 | ||||
Beginning Balance at Mar. 31, 2023 | $ 2 | 587,094 | 3,694 | (500,568) | 90,222 |
Beginning Balance (shares) at Mar. 31, 2023 | 48,686,263 | ||||
Share based compensation activity | 7,271 | 7,271 | |||
Share based compensation activity (shares) | 35,000 | ||||
Issuance of shares in connection with PIPE, net of issuance costs | 57,947 | 57,947 | |||
Issuance of shares in connection with PIPE, net of issuance costs (shares) | 10,773,913 | ||||
Other comprehensive income (loss) | (2,541) | (2,541) | |||
Net loss | (29,581) | (29,581) | |||
Issuance of shares in connection with asset acquisitions | 209 | 209 | |||
Issuance of shares in connection with asset acquisitions (shares) | 40,138 | ||||
Balance at Jun. 30, 2023 | $ 2 | 652,521 | 1,153 | (530,149) | 123,527 |
Balance (shares) at Jun. 30, 2023 | 59,535,314 | ||||
Share based compensation activity | 6,765 | 6,765 | |||
Share based compensation activity (shares) | 61,837 | ||||
Issuance costs of May PIPE shares | (116) | (116) | |||
Other comprehensive income (loss) | 6,007 | 6,007 | |||
Net loss | (44,297) | (44,297) | |||
Balance at Sep. 30, 2023 | $ 2 | $ 659,170 | $ 7,160 | $ (574,446) | $ 91,886 |
Balance (shares) at Sep. 30, 2023 | 59,597,151 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Jun. 30, 2023 | Sep. 30, 2023 | |
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY | ||
Stock issuance costs | $ 4,119 | |
Foreign currency translation, tax | $ 4,003 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (104,242) | $ (102,302) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 20,756 | 21,818 |
Foreign currency loss | 2,915 | 25,911 |
Depreciation and amortization | 9,818 | 6,231 |
Net change in right-of-use assets and liabilities | (153) | (85) |
Loss (gain) on disposal of equipment, furniture and fixtures | 89 | (38) |
Amortization of interest on asset retirement obligations | 130 | 125 |
Amortization of debt discount | 809 | 170 |
Fair value adjustment | (53) | (615) |
(Increase) decrease in operating assets: | ||
Accounts receivable - related party | (198) | (2,150) |
Prepaid expenses | 1,212 | (2,838) |
Tax incentive receivable | (2,283) | 6,518 |
Other current assets | 898 | 578 |
Other assets | (15) | (111) |
Increase (decrease) in operating liabilities: | ||
Accounts payable | 5,393 | 8,628 |
Accrued expenses | (13,917) | 944 |
Other current liabilities | 1,593 | |
Deferred revenue - related party | (11,977) | (21,208) |
Net cash used in operating activities | (90,818) | (56,831) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (17,144) | (36,471) |
Net cash used in investing activities | (17,144) | (36,471) |
Cash flows from financing activities: | ||
Exercise of share options | 192 | |
Payments of withholdings on shares withheld for income taxes | (1,519) | (2,774) |
Proceeds from issuance of ordinary shares | 61,950 | |
Issuance costs in connection with ordinary shares | (4,119) | |
Proceeds from issuance of note payable | 75,000 | |
Payment of financing fees | (2,051) | |
Net cash (used in) provided by financing activities | 56,312 | 70,367 |
Net decrease in cash and cash equivalents | (51,650) | (22,935) |
Effect of exchange rate changes on cash | 537 | (62) |
Cash and cash equivalents at beginning of the period | 115,516 | 137,703 |
Cash and cash equivalents at end of the period | 64,403 | 114,706 |
Supplemental disclosure of non-cash transactions: | ||
Fixed asset acquisition included in accounts payable and accrued expenses at end of the period | 2,941 | 7,598 |
Right-of-use assets obtained in exchange for lease liabilities | 1,793 | |
Asset retirement obligations incurred in connection with leases | 8 | |
Warrants issued in connection with note payable | 2,273 | |
Issuance of shares in connection with asset acquisition | 209 | |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | $ 9,965 | $ 165 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Organization and Basis of Presentation | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation The Company MeiraGTx Holdings plc and subsidiaries (the “Company” or “Meira Holdings”), an exempted company incorporated under the laws of the Cayman Islands, is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. The Company has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology that allows precise, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, the Company has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. The Company’s initial focus is on three distinct areas of unmet medical need: ocular, including both inherited retinal diseases as well as large degenerative ocular diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, the Company intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases. The Company also owns and operates a current good manufacturing practices, or cGMP, multi-product, multi-viral vector manufacturing facility in London, United Kingdom (“UK”), which includes fill and finish capabilities and can supply the Company’s clinical and potential commercial material. Additionally, the Company expanded its manufacturing and supply chain capabilities by acquiring a second cGMP viral vector manufacturing facility and its first cGMP plasmid and DNA production facility in Shannon, Ireland. The Company completed the acquisition of these facilities in January 2021. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Interim Financial Statements The accompanying condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of management, the condensed consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary in order to make the condensed consolidated financial statements not misleading. Operating results for the nine-month period ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “Form 10-K”). 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 September 30, 2023 totaled $574.4 million, 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; expanding and protecting the Company’s intellectual property portfolio; dependence on third parties; and dependence on key personnel. For the nine months ended September 30, 2023, the Company used $90.8 million in cash flows from operations and there are no assurances that the Company will generate positive cash flows in the future. Additionally, 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 September 30, 2023, the Company had cash, cash equivalents and restricted cash in the amount of $64.4 million, which consisted of depository accounts and money market accounts held at large international banks. On January 30, 2019, the Company entered into a collaboration, option and license agreement with Janssen Pharmaceuticals, Inc. (“Janssen”), one of the Janssen Pharmaceuticals Companies of Johnson & Johnson (the “Collaboration Agreement”), for the research, development and commercialization of gene therapies for the treatment of inherited retinal diseases (“IRD”). Under the terms of the Collaboration Agreement, the Company received an upfront payment of $100.0 million in March 2019 and a milestone payment of $30.0 million in December 2021. The Company also receives 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. The Company estimates that its cash, and cash equivalents on-hand and accounts receivable – related party at September 30, 2023, together with the proceeds from the Sanofi Private Placement (as defined and further described in Note 11), will be sufficient to cover its expenses for at least the next twelve months from the date of issuance of these condensed consolidated 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 capital resources and operations to date have been funded primarily with the proceeds from the Collaboration Agreement and private and public equity offerings, as well as the proceeds from the debt financing described in Note 9. 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. The pandemic caused by the novel coronavirus, or COVID-19, and mitigation measures also have had, and may continue to have, an adverse impact on global economic conditions, which could have an adverse effect on the Company’s ability to raise capital when needed. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 2. Summary of Significant Accounting Policies and Recent Accounting Pronouncements Certain of the Company’s significant accounting policies are described below. All of the Company’s significant accounting policies are disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2022 included in the Company’s Form 10-K. Consolidation The accompanying condensed consolidated financial statements include the accounts of Meira Holdings and its wholly owned subsidiaries: MeiraGTx Limited, a limited company incorporated under the laws of England and Wales; MeiraGTx, LLC, a Delaware limited liability company (“Meira LLC”); MeiraGTx UK II Limited, a limited company incorporated under the laws of England and Wales (“Meira UK II”); MeiraGTx Ireland DAC, a designated activity company incorporated under the laws of Ireland (“Meira Ireland”); MeiraGTx Netherlands, B.V., a private company with limited liability incorporated under the laws of the Netherlands (“Meira Netherlands”); MeiraGTx Belgium, a private company with limited liability incorporated under the laws of Belgium (“Meira Belgium”); BRI-Alzan, Inc., a Delaware corporation (“BRI-Alzan”); MeiraGTx Bio, Inc., a Delaware corporation (“Meira Bio”); MeiraGTx B.V., a private company with limited liability incorporated under the laws of the Netherlands (“Meira B.V.”); MeiraGTx Neurosciences, Inc., a Delaware corporation (“Meira Neuro”); MeiraGTx Therapeutics, Inc., a Delaware corporation (“Meira Therapeutics”); and MeiraGTx UK Limited, a limited company incorporated under the laws of England and Wales (“Meira UK”). 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 condensed 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 condensed consolidated financial statements, management used significant estimates in the following areas, among others: collaboration revenue, the accounting for research and development costs, share-based compensation, valuation of warrants, leases, asset retirement obligations and tax incentive receivable. Restricted Cash Restricted cash represents a guarantee in connection with a research and innovation grant from IDA Ireland which offers tax incentives related to the Company’s manufacturing facilities in Shannon, Ireland. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash reported in the Company’s condensed consolidated balance sheets to the total of the amount presented in the consolidated statements of cash flows (in thousands): September 30, December 31, 2023 2022 Cash and cash equivalents $ 63,365 $ 115,516 Restricted cash 1,038 — Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 64,403 $ 115,516 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 the Company’s 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 (in thousands): Fair Value Measurement Using: Significant Significant Other Significant September 30, Observable Inputs Observable Inputs Unobservable Description 2023 (Level 1) (Level 2) (Level 3) Restricted cash $ 1,038 $ 1,038 $ — $ — Cash equivalents $ 29,667 $ 29,667 $ — $ — Fair Value Measurement Using: Significant Significant Other Significant December 31, Observable Inputs Observable Inputs Unobservable Description 2022 (Level 1) (Level 2) (Level 3) Cash equivalents $ 57,336 $ 57,336 $ — $ — Other long-term liabilities $ 262 $ 262 $ — $ — At September 30, 2023, the Company's financial instruments included cash and cash equivalents, restricted cash, accounts receivable - related party, and accounts payable. The carrying amounts reported in the Company's consolidated financial statements for these instruments approximates their respective fair values because of the short-term nature of these instruments. In addition, at September 30, 2023, the Company believed the carrying value of the Tranche 1 Notes (as defined in Note 9) approximates fair value as the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. Equity Method and Other Investments The Company accounts for equity investments under the equity method of accounting when the requirements for consolidation are not met, and the Company has significant influence over the operations of the investee. Equity method investments are initially recorded at cost and subsequently adjusted for the Company’s share of net income or loss and cash contributions and distributions and are included in equity method and other investments in the accompanying condensed consolidated balance sheets. Equity investments that do not result in consolidation and are not accounted for under the equity method are measured at fair value, with any changes in fair value recognized in net income (loss). For any such investments that do not have readily determinable fair values, the Company elects the measurement alternative to measure the investments at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. Equity method investments are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. If it is determined that a loss in value of the equity method investment is other than temporary, an impairment loss is measured based on the excess of the carrying amount of an investment over its estimated fair value. Impairment analyses are based on current plans, intended holding periods, and available information at the time the analysis is prepared. Leases The Company accounts for leases in accordance with FASB standard ASC 842, Leases From time to time the Company enters into direct financing lease arrangements that include a lessee obligation to purchase the leased asset at the end of the lease term, a bargain purchase option, or provides for minimum lease payments with a present value of 90% or more of the fair value of the leased asset at the date of lease inception. Operating leases where the Company is the lessee are included in right-of-use (“ROU”) assets and lease obligations on the Company’s condensed consolidated balance sheets. The lease obligations are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date and subsequent reporting periods. Finance leases where the Company is the lessee are included in ROU assets and lease obligations on the Company’s condensed consolidated balance sheets. The lease obligations are initially measured in the same manner as for operating leases and are subsequently measured at amortized cost using the effective interest method. Key estimates and judgments include how the Company determined (1) the discount rate used to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As most of the Company’s leases where it is the lessee do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company uses the implicit rate when readily determinable. The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a lessee option to extend (or not to terminate) the lease that is reasonably certain to be exercised, or an option to extend (or not to terminate) the lease controlled by the lessor. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, minus any accrued lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset, or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented separately from interest expense on the lease liability. The Company has elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less at lease commencement. Lease payments associated with short-term leases are recognized as an expense on a straight-line basis over the lease term. Asset Retirement Obligations 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, the Company estimates the fair value of its asset retirement obligations using Level 3 present value techniques, in which estimates of future cash flows associated with retirement activities are discounted using a credit-adjusted risk-free rate. Asset retirement obligations currently reported as other liabilities on the condensed consolidated balance sheet were measured during a period of historically low interest rates. The impact on measurements of new asset retirement obligations using different rates in the future may be significant. The Company uses estimates to determine the 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 condensed consolidated statements of operations and comprehensive loss. The change in asset retirement obligations is as follows (in thousands): For the Nine-Month Period Ended September 30, 2023 2022 Balance at beginning of period $ 2,179 $ 2,081 Additional asset retirement obligations incurred during the period — 8 Amortization of interest 130 125 Effects of exchange rate changes 10 (133) Balance at end of period $ 2,319 $ 2,081 Collaboration Arrangements The Company evaluates its collaborative arrangements pursuant to ASC 808, Collaborative Arrangements Revenue from Contracts with Customers ASC 808 does not address recognition or measurement matters related to collaborative arrangements. Payments between participants pursuant to a collaborative arrangement that are within the scope of other authoritative accounting literature on income statement classification are accounted for using the relevant provisions of that literature. If the payments are not within the scope of other authoritative accounting literature, the income statement classification for the payments is based on an analogy to authoritative accounting literature or if there is no appropriate analogy, a reasonable, rational and consistently applied accounting policy election. Payments received from a collaboration partner to which this policy applies may include upfront payments in respect of a license of intellectual property, development and commercialization-based milestones, and royalties. Refer to the discussion in Note 7 for further information related to the accounting for the Collaboration Agreement. Revenue Recognition Arrangements with collaborators may include licenses to intellectual property, research and development services, manufacturing services for clinical and commercial supply, and participation on joint steering committees. The Company evaluates the promised goods or services to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of development of the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property, and whether the promised goods or services are integral to or dependent on other promises in the contract. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract. When the Company concludes that a contract should be accounted for as a combined performance obligation and recognized over time, the Company must then determine the period over which revenue should be recognized and the method by which to measure revenue. The Company generally recognizes revenue using a cost-based input method. The Collaboration Agreement with Janssen is accounted for under ASC 808, however, as ASC 808 does not address recognition or measurement matters such as determining the appropriate unit of accounting or when the recognition criteria are met, the Company accounts for the consideration received from Janssen in accordance with ASC 606. In accordance with ASC 606, the Company recognizes revenue when its customer or collaborator obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: i. identify the contract(s) with a customer; ii. identify the performance obligations in the contract; iii. determine the transaction price; iv. allocate the transaction price to the performance obligations within the contract; and v. recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be by analogy within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements typically consist of a license to the Company’s intellectual property and research, development and manufacturing services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources, and (ii) is separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation. The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable, or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most likely amount method or expected amount method, whichever best estimates the amount expected to be received. The Company then considers any constraints on the variable consideration and includes in the transaction price variable consideration to the extent it is deemed probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s condensed consolidated balance sheet. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue – related party, current. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue – related party. The Company’s collaboration revenue arrangements include the following: Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of an agreement that includes research and development milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty.) The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any revenue related to sales-based royalties or milestone payments based on the level of sales. Research and Development Services: The Company is incurring research and development costs, with Janssen responsible for up to 100% of the costs, depending on the type of research and development services being performed. The Company records costs associated with the development activities as research and development expenses in the condensed consolidated statements of operations and comprehensive loss consistent with ASC 730, 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 for the drug product for the clinical studies and preclinical activities; facilities; supplies; rent, insurance, certain legal fees, share-based compensation, depreciation and other costs associated with clinical and preclinical activities and regulatory operations. Research funding under collaboration agreements and refundable research and development credits / tax credits 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 condensed consolidated financial statements as prepaid expenses or accrued expenses, as the case may be. 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. 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: September 30, September 30, 2023 2022 Share options 8,307,672 6,968,181 Restricted share units 2,661,250 2,182,500 Deferred share units 185,000 110,000 Warrants 700,000 — Restricted ordinary shares subject to forfeiture 14,049 28,097 11,867,971 9,288,778 Segment Information Management has concluded it has a single reporting segment for purposes of reporting financial condition and results of operations. The Company’s license revenue, research funding and deferred revenue from its Collaboration Agreement are generated in the United Kingdom. The following table summarizes long-lived assets by geographical area (in thousands): September 30, December 31, 2023 2022 United States $ 12,002 $ 14,382 United Kingdom 33,585 36,775 European Union 109,291 105,013 $ 154,878 $ 156,170 Recent Accounting Pronouncements Adopted In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Equity Method and Other Investm
Equity Method and Other Investments | 9 Months Ended |
Sep. 30, 2023 | |
Equity Method and Other Investments | |
Equity Method and Other Investments | 3. Equity Method and Other Investments The Company’s investments consist of the following (in thousands): September 30, 2023 Investee Investment Type Ownership Percentage Carrying Value Cost Basis Visiogene LLC Equity Method Investment 25 % $ 5,156 $ 5,165 Other Equity Investment 1.6 % 1,170 1,500 Total equity method and other investments $ 6,326 $ 6,665 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Accrued Expenses | 4. Accrued Expenses Accrued expenses for the periods presented are comprised of the following (in thousands): September 30, December 31, 2023 2022 Clinical trial costs $ 10,827 $ 13,041 Research and development 4,735 7,400 Interest on Tranche 1 Notes 2,898 — Manufacturing costs 2,593 4,326 Professional fees 2,447 732 Compensation and benefits 1,773 9,600 Fixed assets 1,468 3,093 Consulting 1,278 694 Other 232 932 $ 28,251 $ 39,818 |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Compensation | |
Share-Based Compensation | 5. Share-Based Compensation Equity Incentive Plans The Company’s 2018 Incentive Award Plan and 2016 Equity Incentive Plan (collectively, the “Plans”) were adopted by the Company’s board of directors and shareholders. Under the Plans, the Company has granted share options and restricted share units (“RSUs”) to selected officers, employees, non-employee members of the board of directors and non-employee consultants. The Company’s board of directors or a committee thereof administers the Plans. Upon the adoption of the 2018 Incentive Award Plan, the Company ceased issuing awards under the 2016 Equity Incentive Plan. Options 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 December 31, 2022 and for the nine-month period ended September 30, 2023 is as follows (in thousands, except share and per share amounts): Weighted- Weighted- Average Average Remaining Number of Exercise Contractual Options Price Term (years) Outstanding at December 31, 2022 6,858,409 $ 14.03 6.86 years Granted 1,591,840 $ 8.49 Exercised — $ — Forfeited (142,577) $ 15.90 Outstanding at September 30, 2023 8,307,672 $ 12.95 6.65 years Options exercisable at September 30, 2023 5,484,586 $ 13.12 5.62 years Aggregate intrinsic value of options outstanding as of September 30, 2023 $ 790 Aggregate intrinsic value of options exercisable as of September 30, 2023 $ 790 Options granted under the Plans have a maximum contractual term of ten years. Options granted generally vest 25% on the first anniversary of the date of grant and the balance ratably over the next 36 months. Options granted to directors when they join the board generally vest in 36 equal monthly installments following the date of grant, and annual options granted to directors generally vest on the earlier of the first anniversary of the date of grant or the day before the Company’s annual meeting of shareholders after the date of grant. The total share-based compensation expense recorded in connection with the options was $3.5 The total share-based compensation expense recorded in connection with the options was $10.3 million and $12.3 million, of which $3.9 million and $4.3 million was recorded as general and administrative expense and $6.4 million and $8.0 million was recorded as research and development expense during the nine-month periods ended September 30, 2023 and 2022, respectively. The total fair value of options vested during the three-month periods ended September 30, 2023 and 2022 was $2.8 The total fair value of options vested during the nine-month periods ended September 30, 2023 and 2022 was $12.5 million and $13.6 million, respectively. The weighted-average grant date fair value of options granted during the nine-month periods ended September 30, 2023 and 2022 was $5.67 per share and $13.07 per share, respectively. The grant date fair values of the share options granted were estimated using the Black-Scholes option valuation model with the following ranges of assumptions: 2023 2022 Risk-free interest rate 3.86 - 4.48% 1.56 - 3.37% Expected volatility 72% 80% Expected dividend yield 0% 0% Expected term (in years) 3.6 - 6.1 5.5 - 6.1 As of September 30, 2023, the total compensation expense relating to unvested options granted that had not yet been recognized was $22.0 million, which is expected to be realized over a period of 4.0 years. The Company will issue shares upon exercise of options from ordinary shares reserved under the Plans. Restricted Share Units A summary of the Company’s RSU activity related to employees, non-employee members of the board of directors and non-employee consultants as of December 31, 2022 and for the nine-month period ended September 30, 2023 is as follows: Weighted- Number of Average Restricted Grant Date Share Units Fair Value Outstanding at December 31, 2022 2,182,500 $ 18.59 Granted 1,097,500 $ 7.05 Vested (618,750) $ 15.17 Outstanding at September 30, 2023 2,661,250 $ 14.63 RSUs granted generally vest 50% on the second anniversary of the date of grant and 25% on the third and fourth Total share-based compensation expense recorded in connection with the RSUs was $3.6 million and $3.2 million, of which $2.5 million and $2.2 million was recorded as general and administrative expense and $1.1 million and $1.0 million was recorded as research and development expense during the three-month periods ended September 30, 2023 and 2022, respectively. Total share-based compensation expense recorded in connection with the RSUs was $10.5 million and $9.5 million, of which $7.3 million and $6.7 million was recorded as general and administrative expense and $3.2 million and $2.8 million was recorded as research and development expense during the nine-month periods ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the total compensation expense relating to unvested RSUs granted that had not yet been recognized was $25.3 million, which is expected to be realized over a period of 3.4 To satisfy employee minimum statutory tax withholding requirements for restricted share units that vest, the Company withholds a portion of the vesting ordinary shares. During the nine months ended September 30, 2023 and 2022, the Company withheld 237,859 During the three-month and nine-month periods ended September 30, 2023 and 2022, the Company recognized total share-based compensation expense in the accompanying condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three-Month Period Ended September 30, 2023 2022 Research and development $ 3,250 3,482 General and administrative 3,803 3,455 Total share-based compensation $ 7,053 $ 6,937 Nine-Month Period Ended September 30, 2023 2022 Research and development $ 9,569 10,780 General and administrative 11,187 11,038 Total share-based compensation $ 20,756 $ 21,818 During the three-month period ended September 30, 2023, the Company modified certain awards for two participants and recognized $0.04 million related to the modifications, $0.01 million of which was recognized in research and development expense and $0.03 million was recognized in general and administrative expense. During the three-month period ended September 30, 2022, the Company modified certain awards for two participants and recognized $0.1 million related to the modifications, $0.08 million of which was recognized in research and development expense and $0.05 million was recognized in general and administrative expense. The terms of such modifications included, on an award-by-award basis, acceleration of the vesting period and/or extensions of the post-employment period to exercise. 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 nine-month periods ended September 30, 2023 and 2022. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Taxes | |
Income Taxes | 6. Income Taxes The Company did not record a provision for income taxes for the three-month and nine-month periods ended September 30, 2023 and 2022, as the Company has generated losses for all periods. The Company periodically evaluates the realizability of its deferred tax assets based on all available evidence, both positive and negative. The realization of deferred tax assets is dependent on the Company’s ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets. The Company weighed both positive and negative evidence and determined that there is a continued need for a full valuation allowance on its deferred tax assets (after consideration of the reversal of the deferred tax liabilities for the ROU assets and fixed assets) in the United States, United Kingdom, Ireland and Netherlands as of September 30, 2023. Should the Company determine that it would be able to realize its remaining deferred tax assets in the foreseeable future, an adjustment to its remaining deferred tax assets would cause a material increase to income in the period such determination is made. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions | |
Related Party Transactions | 7. Related-Party Transactions Collaboration and License Agreements Janssen Pharmaceuticals, Inc. On January 30, 2019, the Company entered into a Collaboration Agreement with Janssen for the research, development and commercialization of gene therapies for the treatment of IRDs. Under the agreement, Janssen paid the Company a non-refundable upfront fee of $100.0 million. 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 three product candidates (“Clinical IRD Product Candidates”) globally. Pursuant to the Collaboration Agreement, the Company and Janssen also agreed on a research collaboration to develop a pipeline of preclinical inherited retinal disease gene therapy candidates (“Research IRD Product Candidates”), pursuant to which Janssen could opt-in for a fee for each of the specified targets (each an “Option Target”) to obtain certain development, manufacturing and commercialization rights for the Research IRD Product Candidates. Unless terminated earlier under certain termination clauses, the Collaboration Agreement will continue in effect, on a product-by-product and country-by-country basis, until such time as the royalty terms expire in such country. The Company has determined enforceable rights exist in the Collaboration Agreement as the termination clauses are substantive termination penalties by way of the non-refundable upfront fee and the reversion of any licensed intellectual property granted to Janssen upon the termination of the agreement. On February 27, 2019, in connection with a private placement, the Company issued 2,898,550 ordinary shares to Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”), the investment arm of Johnson and Johnson and owner of Janssen, on the same terms and conditions as the other investors in the offering. After the offering, JJDC became a related party. Additionally, on November 9, 2022, in connection with a private placement, the Company issued 3,742,514 ordinary shares to JJDC, at a purchase price of $6.68 per share, for gross proceeds of approximately $25.0 million. Clinical IRD Product Candidates Under the Collaboration Agreement, the Company and Janssen will jointly develop Clinical IRD Product Candidates to permit Janssen to commercialize such Clinical IRD Product Candidates under an exclusive license from the Company. In general, the Company will have the primary responsibility to develop each Clinical IRD Product Candidate in accordance with the development plan for each Clinical IRD Product Candidate, including where applicable, conducting any necessary research in order to submit the applicable regulatory filings to regulatory authorities. The Company will manufacture these products in its cGMP manufacturing facility for both clinical and commercial supply. Janssen will pay 100% of the clinical and commercialization costs of the products and the Company is eligible to receive untiered 20% royalties on net sales of products and additional development and commercialization milestones up to $340.0 million. The Company received its first milestone payment of $30.0 million in December 2021. Revenue Recognition under the Collaboration Agreement The Collaboration Agreement is accounted for under ASC 808, however, ASC 808 does not address recognition or measurement matters. Therefore, the Company will account for the recognition and measurement of consideration under ASC 606. In determining the appropriate amount of revenue to be recognized under ASC 606, the Company performed the following steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company evaluated the potential performance obligations in the contract, which included the exclusive license to Clinical IRD Product Candidates, the research, development and manufacturing services (“the services”), and the participation in various joint committees and determined that none of the performance obligations by themselves were distinct. Goods and services that are not distinct are bundled with other goods or services in the contract until a bundle of goods or services that is distinct is created. The services, when combined with the licenses, represent a bundle and should be accounted for as a single performance obligation due to the relevance of the services to the value of the early-stage license and the potential for the intellectual property to be significantly modified during the services period. The Company also evaluated whether or not the right to purchase exclusive option rights for specified Research IRD Product Candidates represents future performance obligations and concluded that these represent a separate buyer decision at market rates, rather than a material right performance obligation. As such, these options have been excluded from the initial allocation of transaction price. Under ASC 606, the Company recognized collaboration revenue using the cost-to-cost input method, which it believes best depicts the transfer of control to the customer. Under the cost-to-cost input method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the combined performance obligation by the potential product candidate. Under this method, revenue is being recorded as a percentage of the estimated transaction price based on the extent of progress towards completion. Under ASC 606, the estimated transaction price includes variable consideration subject to constraints. The Company does not include variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will occur when any uncertainty associated with the variable consideration is resolved. The estimate of the Company’s measure of progress and estimate of variable consideration to be included in the transaction price will be updated at each reporting date as a change in estimate. The amount related to the unsatisfied portion will be recognized as that portion is satisfied over time. Under ASC 606 the Company accounts for (i) the licenses it conveyed with respect to the Clinical IRD Product Candidates and (ii) its obligations to perform services as a single performance obligation under the Collaboration Agreement with Janssen on a product candidate basis. Janssen’s right to purchase exclusive options to obtain certain development, manufacturing and commercialization rights for specified Research IRD Product Candidates are accounted for separately as they do not represent material rights, based on the criteria of ASC 606. In 2019, the Company received a $100.0 million non-refundable upfront fee from Janssen and during the year ended December 31, 2021, received a $30.0 million milestone payment. The Company allocated these amounts plus other variable consideration not subject to constraint to each identified performance obligation using a combination of methods allowable under ASC 606. The Company applies the practical expedient in Topic 606 and does not include disclosures regarding amounts for variable consideration allocated to wholly-unsatisfied performance obligations or wholly-unsatisfied distinct goods that form part of a single performance obligation, if any. This variable consideration includes expected reimbursement of research and development costs. During the three-month periods ended September 30, 2023 and 2022, the Company recognized $5.1 million and $4.8 million, respectively, of the deferred revenue – related party as license revenue. During the nine-month periods ended September 30, 2023 and 2022, the Company recognized $12.0 million and $21.2 million, respectively, of the deferred revenue – related party as license revenue. The Company also recognized $16.2 million and $24.1 million during the three-month periods ended September 30, 2023 and 2022, respectively, related to the reimbursement of research and development expenses, which were recorded as an offset to research and development expenses. The Company also recognized $60.6 million and $53.4 million during the nine-month periods ended September 30, 2023 and 2022, respectively, related to the reimbursement of research and development expenses, which were recorded as an offset to research and development expenses. As of September 30, 2023, the Company expects to recognize the remaining $31.1 million in deferred revenue associated with the non-refundable upfront fee and milestone payment over the estimated research and development period using the cost-to-cost input method over an estimated period of approximately 3.0 A summary of the deferred revenue recognition is as follows (in thousands): Deferred revenue at December 31, 2022 $ 42,559 Deferred revenue recognized as license revenue during the nine-month period ended September 30, 2023 (11,977) Effects of exchange rate changes 531 Deferred revenue at September 30, 2023 $ 31,113 Debt Financing On August 2, 2022 the Company, as borrower, and Meira UK II and Meira Ireland, as guarantors (the “Subsidiary Guarantors”), entered into a senior secured financing arrangement (the “Financing Agreement”) by and among the Company, the Subsidiary Guarantors, the lenders and other parties from time to time party thereto and Perceptive Credit Holdings III, LP, as administrative agent and lender (“Perceptive”). On December 19, 2022, the Financing Agreement was converted to a note purchase agreement (as converted, the “Note Purchase Agreement”) between the same parties and under substantially the same terms and conditions as the Financing Agreement, subject to certain customary note constitution terms. On August 10, 2023, the Company and the Subsidiary Guarantors entered into a Consent and Amendment to Amended and Restated Note Purchase Agreement and Guaranty (the “Consent and Amendment”) by and among the Company, the Subsidiary Guarantors, the noteholders and other parties from time to time party thereto and Perceptive, which amends the Note Purchase Agreement. Perceptive Advisors, LLC, an affiliate of Perceptive, is a greater than 10% holder of the ordinary shares of the Company. Additionally, Ellen Hukkelhoven, Ph.D., a director of the Company, is an employee of Perceptive Advisors, LLC. Refer to the discussion in Note 9 for further information related to the accounting for the debt financing. May 2023 Private Placement On May 3, 2023, the Company issued 10,773,913 ordinary shares in a private placement for gross proceeds of $62.0 million, excluding offering costs of approximately $4.1 million. Perceptive Advisors, LLC and Adage Capital Partners, L.P. a greater than 5% holder of the ordinary shares of the Company, purchased 4,347,826 and 1,565,217 of the ordinary shares, respectively, issued on the same terms and conditions as the other investors in the offering. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Leases | 8. Leases The Company has commitments under operating leases for laboratory, warehouse, clinical trial sites and office space. The Company also has finance leases for manufacturing space and office equipment. The Company’s leases have initial lease terms ranging from 3 years to 191 years. Certain lease agreements contain provisions for future rent increases. Payments due under the lease contracts include fixed payments. Total rent expense under these leases was $1.4 million and $1.3 million for the three-month periods ended September 30, 2023 and 2022, respectively. Total rent expense under these leases was $4.1 million and $4.0 million for the nine-month periods ended September 30, 2023 and 2022, respectively. During the nine-month period ended September 30, 2022, the Company recognized three operating leases for locations in connection with its clinical trials for its IRD product candidates and office and warehouse space, with initial lease terms between 3 years and 9 years. Certain lease agreements contain provisions for tenant allowances and future rent increases. Payments due under the lease contracts include fixed payments. In conjunction with these operating leases, the Company recognized initial operating lease right-of-use assets in the amount of $1.8 million and corresponding lease liabilities in the amount of $1.8 million which are included in the right-of-use assets and lease obligations in the condensed consolidated balance sheets as of September 30, 2022. The components of lease cost for the three-month and nine-month periods ended September 30, 2023 and 2022 are as follows (in thousands): Three-Month Period Ended September 30, 2023 2022 Finance lease cost Amortization of right-of-use assets $ 274 $ 257 Interest on lease liabilities — — Total finance lease cost 274 257 Operating lease cost 1,371 1,311 Short-term lease cost 40 39 Total lease cost $ 1,685 $ 1,607 Nine-Month Period Ended September 30, 2023 2022 Finance lease cost Amortization of right-of-use assets $ 838 $ 825 Interest on lease liabilities — 1 Total finance lease cost 838 826 Operating lease cost 4,103 3,986 Short-term lease cost 119 115 Total lease cost $ 5,060 $ 4,927 Amounts reported in the condensed consolidated balance sheets for leases where the Company is the lessee as of September 30, 2023 and December 31, 2022 were as follows (in thousands): September 30, December 31, 2023 2022 Operating leases Right-of-use asset $ 17,446 $ 20,109 Capitalized lease obligations $ 18,348 $ 21,215 Finance leases Right-of-use asset $ 23,680 $ 24,718 Capitalized lease obligations $ — $ — Weighted-average remaining lease term Operating leases 5.0 years 5.6 years Finance leases 175.1 years 175.8 years Weighted-average discount rate Operating leases 8.8 % 8.8 % Finance leases 8.0 % 8.0 % Other information related to leases for the three-month and nine-month periods ended September 30, 2023 and 2022 are as follows (in thousands): Three-Month Period Ended September 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from finance leases $ — $ 4 Operating cash flows from operating leases $ 1,407 $ 1,309 Nine-Month Period Ended September 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from finance leases $ — $ 11 Operating cash flows from operating leases $ 4,233 $ 4,044 Financing cash flows from finance leases $ — $ — Right-of-use assets obtained in exchange for lease liabilities Operating leases $ — $ 1,793 Future minimum lease payments under non-cancellable leases as of September 30, 2023 are as follows (in thousands): Operating Leases 2023 $ 1,409 2024 5,472 2025 5,436 2026 5,169 2027 1,844 Thereafter 2,876 Total undiscounted lease payments $ 22,206 Less: Imputed interest (3,858) Total lease liabilities $ 18,348 |
Debt Financing
Debt Financing | 9 Months Ended |
Sep. 30, 2023 | |
Debt Financing Agreements | |
Debt Financing | 9. Debt Financing On August 2, 2022 the Company, and the Subsidiary Guarantors, entered into the Financing Agreement with Perceptive. On December 19, 2022, the Financing Agreement was converted to a Note Purchase Agreement between the same parties and under substantially the same terms and conditions as the Financing Agreement, subject to certain customary note constitution terms. On August 10, 2023, the Company and the Subsidiary Guarantors entered into the Consent and Amendment with Perceptive. The Note Purchase Agreement provides for an initial $75.0 million notes issuance (the “Tranche 1 Notes”). Pursuant to the Consent and Amendment, the Company may request in its sole discretion, and Perceptive has agreed to subscribe to purchase upon such request, an additional $25.0 million notes issuance (the “Tranche 2 Notes”) at any time before August 2, 2024 subject to the terms of the Note Purchase Agreement. month tenor, subject to a 1.00% floor. The annual interest rate was 15.12% at September 30, 2023. As of September 30, 2023, the outstanding balance of the Tranche 1 Notes was $75.0 million plus accrued interest of $2.9 million. During the three-month periods ended September 30, 2023 and 2022, the Company recorded interest expense of $2.9 million and $1.5 million, respectively. During the nine-month periods ended September 30, 2023 and 2022, the Company recorded interest expense of $8.4 million and $1.5 million, respectively. The Company’s obligations under the Note Purchase Agreement are secured by the Company’s London, UK and Shannon, Ireland manufacturing facilities, $3.0 million of the Company’s cash and the bank accounts of the Subsidiary Guarantors, and the issued and outstanding equity interests of the Subsidiary Guarantors. The Note Purchase Agreement imposes covenants that include, among other things, enrolling in a Phase III trial for AAV-RPGR on or before June 30, 2023 and ensuring the Company’s Shannon manufacturing facility meets or satisfies all applicable good manufacturing practice requirements on or before December 31, 2023, both of which the Company has achieved, as well as various restrictions on the Company and the Subsidiary Guarantors, including restrictions pertaining to: (i) the incurrence of additional indebtedness, (ii) limitations on liens, (iii) limitations on certain investments, (iv) making distributions, dividends and other payments, (v) mergers, consolidations and acquisitions, (vi) dispositions of assets, (vii) the Company’s maintenance of at least $3.0 million in a U.S. bank account, (viii) transactions with affiliates, (ix) changes to governing documents, (x) changes to certain agreements and leases and (xi) changes in control; however, certain of these restrictions contain exceptions which allow the Company to license, sell and monetize assets in its AAV-hAQP1 program in development to treat radiation-induced xerostomia, its AAV-GAD program in development to treat Parkinson’s disease and its gene regulation platform technologies. As of September 30, 2023, the Company is in compliance with all covenants. In connection with entering into the Financing Agreement, the Company granted warrants to Perceptive to purchase up to (i) 400,000 ordinary shares of the Company at an exercise price of $15.00 per share and (ii) 300,000 ordinary shares of the Company at an exercise price of $20.00 per share. The warrants are exercisable immediately and expire on August 2, 2027. The Company recorded a debt discount of $2.3 million for the allocated fair value of the warrants. The Company also capitalized certain lender and legal costs associated with the Note Purchase Agreement totaling $2.1 million, which were recorded as a discount to the loan. The aggregate discount of $4.4 million is being amortized to interest expense over the term of the Note Purchase Agreement. The Company amortized $0.3 million and $0.2 million of the discount to interest expense during the three-month periods ended September 30, 2023 and 2022, respectively. The Company amortized $0.8 million and $0.2 million of the debt discount to interest expense during the nine-month periods ended September 30, 2023 and 2022, respectively. At September 30, 2023, the remaining unamortized discount was $3.2 million. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 10. Commitments and Contingencies There were no new material commitments or contingencies entered into during the nine-month period ended September 30, 2023. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Event | |
Subsequent Event | 11. Subsequent Event On October 30, 2023 (the “Closing Date”), the Company entered into an Investment Agreement (the “Investment Agreement”) with Sanofi Foreign Participations B.V. (the “Investor”), a wholly-owned subsidiary of Sanofi, and solely for the limited purposes set forth therein, Sanofi (the “Parent”), pursuant to which, among other things and subject to the terms and conditions specified therein, the Company issued an aggregate of 4,000,000 ordinary shares (the “Shares”), at a purchase price of $7.50 per share (the “Sanofi Private Placement”) for gross proceeds of $30.0 million. The Investment Agreement includes customary representations, warranties and covenants by the Company, the Investor and the Parent. The Investment Agreement restricts the Investor’s ability to sell the Shares for a period of 18 months following the Closing Date, subject to customary exceptions for permitted transfers. In addition, the Investor and the Parent are subject to certain standstill restrictions for a period of 24 months following the Closing Date or, in certain instances, such earlier date as is provided for in the Investment Agreement. The Investment Agreement also provides the Investor and its affiliates with a right of first negotiation for use of the Company’s Riboswitch gene regulation technology for certain Immunology and Inflammation (I&I), including modulation of IL-4 and IL-13, and Central Nervous System (CNS) targets, as well as for GLP-1 and other gut peptides for metabolic disease, and for the Company’s Phase 2 Xerostomia program, in each case, on the terms set forth therein. In connection with the Sanofi Private Placement, the Company also entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the Investor. Pursuant to the terms of the Registration Rights Agreement, the Company is obligated to, among other things, prepare and file with the Securities and Exchange Commission a registration statement to register the Shares for resale on or prior to April 30, 2025. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | |
Consolidation | Consolidation The accompanying condensed consolidated financial statements include the accounts of Meira Holdings and its wholly owned subsidiaries: MeiraGTx Limited, a limited company incorporated under the laws of England and Wales; MeiraGTx, LLC, a Delaware limited liability company (“Meira LLC”); MeiraGTx UK II Limited, a limited company incorporated under the laws of England and Wales (“Meira UK II”); MeiraGTx Ireland DAC, a designated activity company incorporated under the laws of Ireland (“Meira Ireland”); MeiraGTx Netherlands, B.V., a private company with limited liability incorporated under the laws of the Netherlands (“Meira Netherlands”); MeiraGTx Belgium, a private company with limited liability incorporated under the laws of Belgium (“Meira Belgium”); BRI-Alzan, Inc., a Delaware corporation (“BRI-Alzan”); MeiraGTx Bio, Inc., a Delaware corporation (“Meira Bio”); MeiraGTx B.V., a private company with limited liability incorporated under the laws of the Netherlands (“Meira B.V.”); MeiraGTx Neurosciences, Inc., a Delaware corporation (“Meira Neuro”); MeiraGTx Therapeutics, Inc., a Delaware corporation (“Meira Therapeutics”); and MeiraGTx UK Limited, a limited company incorporated under the laws of England and Wales (“Meira UK”). 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 condensed 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 condensed consolidated financial statements, management used significant estimates in the following areas, among others: collaboration revenue, the accounting for research and development costs, share-based compensation, valuation of warrants, leases, asset retirement obligations and tax incentive receivable. |
Restricted Cash | Restricted Cash Restricted cash represents a guarantee in connection with a research and innovation grant from IDA Ireland which offers tax incentives related to the Company’s manufacturing facilities in Shannon, Ireland. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash reported in the Company’s condensed consolidated balance sheets to the total of the amount presented in the consolidated statements of cash flows (in thousands): September 30, December 31, 2023 2022 Cash and cash equivalents $ 63,365 $ 115,516 Restricted cash 1,038 — Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 64,403 $ 115,516 |
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 the Company’s 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 (in thousands): Fair Value Measurement Using: Significant Significant Other Significant September 30, Observable Inputs Observable Inputs Unobservable Description 2023 (Level 1) (Level 2) (Level 3) Restricted cash $ 1,038 $ 1,038 $ — $ — Cash equivalents $ 29,667 $ 29,667 $ — $ — Fair Value Measurement Using: Significant Significant Other Significant December 31, Observable Inputs Observable Inputs Unobservable Description 2022 (Level 1) (Level 2) (Level 3) Cash equivalents $ 57,336 $ 57,336 $ — $ — Other long-term liabilities $ 262 $ 262 $ — $ — At September 30, 2023, the Company's financial instruments included cash and cash equivalents, restricted cash, accounts receivable - related party, and accounts payable. The carrying amounts reported in the Company's consolidated financial statements for these instruments approximates their respective fair values because of the short-term nature of these instruments. In addition, at September 30, 2023, the Company believed the carrying value of the Tranche 1 Notes (as defined in Note 9) approximates fair value as the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. |
Equity Method and Other Investments | Equity Method and Other Investments The Company accounts for equity investments under the equity method of accounting when the requirements for consolidation are not met, and the Company has significant influence over the operations of the investee. Equity method investments are initially recorded at cost and subsequently adjusted for the Company’s share of net income or loss and cash contributions and distributions and are included in equity method and other investments in the accompanying condensed consolidated balance sheets. Equity investments that do not result in consolidation and are not accounted for under the equity method are measured at fair value, with any changes in fair value recognized in net income (loss). For any such investments that do not have readily determinable fair values, the Company elects the measurement alternative to measure the investments at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. |
Leases | Leases The Company accounts for leases in accordance with FASB standard ASC 842, Leases From time to time the Company enters into direct financing lease arrangements that include a lessee obligation to purchase the leased asset at the end of the lease term, a bargain purchase option, or provides for minimum lease payments with a present value of 90% or more of the fair value of the leased asset at the date of lease inception. Operating leases where the Company is the lessee are included in right-of-use (“ROU”) assets and lease obligations on the Company’s condensed consolidated balance sheets. The lease obligations are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date and subsequent reporting periods. Finance leases where the Company is the lessee are included in ROU assets and lease obligations on the Company’s condensed consolidated balance sheets. The lease obligations are initially measured in the same manner as for operating leases and are subsequently measured at amortized cost using the effective interest method. Key estimates and judgments include how the Company determined (1) the discount rate used to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As most of the Company’s leases where it is the lessee do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company uses the implicit rate when readily determinable. The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a lessee option to extend (or not to terminate) the lease that is reasonably certain to be exercised, or an option to extend (or not to terminate) the lease controlled by the lessor. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, minus any accrued lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset, or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented separately from interest expense on the lease liability. The Company has elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less at lease commencement. Lease payments associated with short-term leases are recognized as an expense on a straight-line basis over the lease term. |
Asset Retirement Obligations | Asset Retirement Obligations 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, the Company estimates the fair value of its asset retirement obligations using Level 3 present value techniques, in which estimates of future cash flows associated with retirement activities are discounted using a credit-adjusted risk-free rate. Asset retirement obligations currently reported as other liabilities on the condensed consolidated balance sheet were measured during a period of historically low interest rates. The impact on measurements of new asset retirement obligations using different rates in the future may be significant. The Company uses estimates to determine the 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 condensed consolidated statements of operations and comprehensive loss. The change in asset retirement obligations is as follows (in thousands): For the Nine-Month Period Ended September 30, 2023 2022 Balance at beginning of period $ 2,179 $ 2,081 Additional asset retirement obligations incurred during the period — 8 Amortization of interest 130 125 Effects of exchange rate changes 10 (133) Balance at end of period $ 2,319 $ 2,081 |
Collaboration Arrangements | Collaboration Arrangements The Company evaluates its collaborative arrangements pursuant to ASC 808, Collaborative Arrangements Revenue from Contracts with Customers ASC 808 does not address recognition or measurement matters related to collaborative arrangements. Payments between participants pursuant to a collaborative arrangement that are within the scope of other authoritative accounting literature on income statement classification are accounted for using the relevant provisions of that literature. If the payments are not within the scope of other authoritative accounting literature, the income statement classification for the payments is based on an analogy to authoritative accounting literature or if there is no appropriate analogy, a reasonable, rational and consistently applied accounting policy election. Payments received from a collaboration partner to which this policy applies may include upfront payments in respect of a license of intellectual property, development and commercialization-based milestones, and royalties. Refer to the discussion in Note 7 for further information related to the accounting for the Collaboration Agreement. |
Revenue Recognition | Revenue Recognition Arrangements with collaborators may include licenses to intellectual property, research and development services, manufacturing services for clinical and commercial supply, and participation on joint steering committees. The Company evaluates the promised goods or services to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of development of the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property, and whether the promised goods or services are integral to or dependent on other promises in the contract. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract. When the Company concludes that a contract should be accounted for as a combined performance obligation and recognized over time, the Company must then determine the period over which revenue should be recognized and the method by which to measure revenue. The Company generally recognizes revenue using a cost-based input method. The Collaboration Agreement with Janssen is accounted for under ASC 808, however, as ASC 808 does not address recognition or measurement matters such as determining the appropriate unit of accounting or when the recognition criteria are met, the Company accounts for the consideration received from Janssen in accordance with ASC 606. In accordance with ASC 606, the Company recognizes revenue when its customer or collaborator obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: i. identify the contract(s) with a customer; ii. identify the performance obligations in the contract; iii. determine the transaction price; iv. allocate the transaction price to the performance obligations within the contract; and v. recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be by analogy within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements typically consist of a license to the Company’s intellectual property and research, development and manufacturing services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources, and (ii) is separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation. The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable, or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most likely amount method or expected amount method, whichever best estimates the amount expected to be received. The Company then considers any constraints on the variable consideration and includes in the transaction price variable consideration to the extent it is deemed probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s condensed consolidated balance sheet. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue – related party, current. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue – related party. The Company’s collaboration revenue arrangements include the following: Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of an agreement that includes research and development milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty.) The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any revenue related to sales-based royalties or milestone payments based on the level of sales. Research and Development Services: The Company is incurring research and development costs, with Janssen responsible for up to 100% of the costs, depending on the type of research and development services being performed. The Company records costs associated with the development activities as research and development expenses in the condensed consolidated statements of operations and comprehensive loss consistent with ASC 730, Research and Development |
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 for the drug product for the clinical studies and preclinical activities; facilities; supplies; rent, insurance, certain legal fees, share-based compensation, depreciation and other costs associated with clinical and preclinical activities and regulatory operations. Research funding under collaboration agreements and refundable research and development credits / tax credits 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 condensed consolidated financial statements as prepaid expenses or accrued expenses, as the case may be. |
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. 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: September 30, September 30, 2023 2022 Share options 8,307,672 6,968,181 Restricted share units 2,661,250 2,182,500 Deferred share units 185,000 110,000 Warrants 700,000 — Restricted ordinary shares subject to forfeiture 14,049 28,097 11,867,971 9,288,778 |
Segment Information | Segment Information Management has concluded it has a single reporting segment for purposes of reporting financial condition and results of operations. The Company’s license revenue, research funding and deferred revenue from its Collaboration Agreement are generated in the United Kingdom. The following table summarizes long-lived assets by geographical area (in thousands): September 30, December 31, 2023 2022 United States $ 12,002 $ 14,382 United Kingdom 33,585 36,775 European Union 109,291 105,013 $ 154,878 $ 156,170 |
Recent Accounting Pronouncements Adopted | Recent Accounting Pronouncements Adopted In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | |
Schedule of Restricted Cash, Cash and Equivalents | September 30, December 31, 2023 2022 Cash and cash equivalents $ 63,365 $ 115,516 Restricted cash 1,038 — Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 64,403 $ 115,516 |
Schedule of Financial Assets and Liabilities Measured at Fair Value | Fair Value Measurement Using: Significant Significant Other Significant September 30, Observable Inputs Observable Inputs Unobservable Description 2023 (Level 1) (Level 2) (Level 3) Restricted cash $ 1,038 $ 1,038 $ — $ — Cash equivalents $ 29,667 $ 29,667 $ — $ — Fair Value Measurement Using: Significant Significant Other Significant December 31, Observable Inputs Observable Inputs Unobservable Description 2022 (Level 1) (Level 2) (Level 3) Cash equivalents $ 57,336 $ 57,336 $ — $ — Other long-term liabilities $ 262 $ 262 $ — $ — |
Schedule of Change in Asset Retirement Obligations | For the Nine-Month Period Ended September 30, 2023 2022 Balance at beginning of period $ 2,179 $ 2,081 Additional asset retirement obligations incurred during the period — 8 Amortization of interest 130 125 Effects of exchange rate changes 10 (133) Balance at end of period $ 2,319 $ 2,081 |
Schedule of Securities Excluded from Computation of Diluted Net Loss per Share | September 30, September 30, 2023 2022 Share options 8,307,672 6,968,181 Restricted share units 2,661,250 2,182,500 Deferred share units 185,000 110,000 Warrants 700,000 — Restricted ordinary shares subject to forfeiture 14,049 28,097 11,867,971 9,288,778 |
Schedule of Long-lived Assets by Geographical Area | September 30, December 31, 2023 2022 United States $ 12,002 $ 14,382 United Kingdom 33,585 36,775 European Union 109,291 105,013 $ 154,878 $ 156,170 |
Equity Method and Other Inves_2
Equity Method and Other Investments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity Method and Other Investments | |
Schedule of equity method and other investments | September 30, 2023 Investee Investment Type Ownership Percentage Carrying Value Cost Basis Visiogene LLC Equity Method Investment 25 % $ 5,156 $ 5,165 Other Equity Investment 1.6 % 1,170 1,500 Total equity method and other investments $ 6,326 $ 6,665 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Schedule of Accrued Expenses | September 30, December 31, 2023 2022 Clinical trial costs $ 10,827 $ 13,041 Research and development 4,735 7,400 Interest on Tranche 1 Notes 2,898 — Manufacturing costs 2,593 4,326 Professional fees 2,447 732 Compensation and benefits 1,773 9,600 Fixed assets 1,468 3,093 Consulting 1,278 694 Other 232 932 $ 28,251 $ 39,818 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Compensation | |
Schedule of Share Option Activity | Weighted- Weighted- Average Average Remaining Number of Exercise Contractual Options Price Term (years) Outstanding at December 31, 2022 6,858,409 $ 14.03 6.86 years Granted 1,591,840 $ 8.49 Exercised — $ — Forfeited (142,577) $ 15.90 Outstanding at September 30, 2023 8,307,672 $ 12.95 6.65 years Options exercisable at September 30, 2023 5,484,586 $ 13.12 5.62 years Aggregate intrinsic value of options outstanding as of September 30, 2023 $ 790 Aggregate intrinsic value of options exercisable as of September 30, 2023 $ 790 |
Schedule of Inputs Used to Determine Fair Value of Share Options | 2023 2022 Risk-free interest rate 3.86 - 4.48% 1.56 - 3.37% Expected volatility 72% 80% Expected dividend yield 0% 0% Expected term (in years) 3.6 - 6.1 5.5 - 6.1 |
Schedule of Restricted Share Unit (RSU) Activity | Weighted- Number of Average Restricted Grant Date Share Units Fair Value Outstanding at December 31, 2022 2,182,500 $ 18.59 Granted 1,097,500 $ 7.05 Vested (618,750) $ 15.17 Outstanding at September 30, 2023 2,661,250 $ 14.63 |
Schedule of Share-Based Compensation Expense | Three-Month Period Ended September 30, 2023 2022 Research and development $ 3,250 3,482 General and administrative 3,803 3,455 Total share-based compensation $ 7,053 $ 6,937 Nine-Month Period Ended September 30, 2023 2022 Research and development $ 9,569 10,780 General and administrative 11,187 11,038 Total share-based compensation $ 20,756 $ 21,818 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions | |
Schedule of Deferred Revenue Recognition | Deferred revenue at December 31, 2022 $ 42,559 Deferred revenue recognized as license revenue during the nine-month period ended September 30, 2023 (11,977) Effects of exchange rate changes 531 Deferred revenue at September 30, 2023 $ 31,113 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Schedule of Components of Lease Cost | Three-Month Period Ended September 30, 2023 2022 Finance lease cost Amortization of right-of-use assets $ 274 $ 257 Interest on lease liabilities — — Total finance lease cost 274 257 Operating lease cost 1,371 1,311 Short-term lease cost 40 39 Total lease cost $ 1,685 $ 1,607 Nine-Month Period Ended September 30, 2023 2022 Finance lease cost Amortization of right-of-use assets $ 838 $ 825 Interest on lease liabilities — 1 Total finance lease cost 838 826 Operating lease cost 4,103 3,986 Short-term lease cost 119 115 Total lease cost $ 5,060 $ 4,927 |
Schedule of Amounts Reported in the Consolidated Balance Sheets for Leases | September 30, December 31, 2023 2022 Operating leases Right-of-use asset $ 17,446 $ 20,109 Capitalized lease obligations $ 18,348 $ 21,215 Finance leases Right-of-use asset $ 23,680 $ 24,718 Capitalized lease obligations $ — $ — Weighted-average remaining lease term Operating leases 5.0 years 5.6 years Finance leases 175.1 years 175.8 years Weighted-average discount rate Operating leases 8.8 % 8.8 % Finance leases 8.0 % 8.0 % |
Schedule of Other Information Related to Leases | Three-Month Period Ended September 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from finance leases $ — $ 4 Operating cash flows from operating leases $ 1,407 $ 1,309 Nine-Month Period Ended September 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from finance leases $ — $ 11 Operating cash flows from operating leases $ 4,233 $ 4,044 Financing cash flows from finance leases $ — $ — Right-of-use assets obtained in exchange for lease liabilities Operating leases $ — $ 1,793 |
Schedule of Future Minimum Payments Under Non-cancellable Leases | Operating Leases 2023 $ 1,409 2024 5,472 2025 5,436 2026 5,169 2027 1,844 Thereafter 2,876 Total undiscounted lease payments $ 22,206 Less: Imputed interest (3,858) Total lease liabilities $ 18,348 |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details) $ in Thousands | 1 Months Ended | 9 Months Ended | |||
Dec. 31, 2021 USD ($) | Mar. 31, 2019 USD ($) | Sep. 30, 2023 USD ($) Program item | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Principal Business Activity [Line Items] | |||||
Number of programs in clinical development | Program | 6 | ||||
Number of distinct areas of unmet medical need | item | 3 | ||||
Accumulated deficit | $ (574,446) | $ (470,204) | |||
Cash flows from operations | (90,818) | $ (56,831) | |||
Cash, cash equivalents | $ 137,703 | $ 64,403 | $ 114,706 | $ 115,516 | |
Janssen Pharmaceuticals Inc | Collaboration Agreement | |||||
Principal Business Activity [Line Items] | |||||
Collaboration agreement upfront payment | $ 100,000 | ||||
Milestone payments | $ 30,000 | ||||
Minimum | |||||
Principal Business Activity [Line Items] | |||||
Offsetting expense, period | 12 months |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Cash and cash equivalents | $ 63,365 | $ 115,516 | ||
Restricted cash | 1,038 | |||
Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows | 64,403 | 115,516 | $ 114,706 | $ 137,703 |
Fair value measurements on recurring basis | Other long-term liabilities | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair value, net asset (liability) | 262 | |||
Fair value measurements on recurring basis | Restricted Cash | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair value, net asset (liability) | 1,038 | |||
Fair value measurements on recurring basis | Cash and cash equivalents | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair value, net asset (liability) | 29,667 | 57,336 | ||
Level 1 | Fair value measurements on recurring basis | Other long-term liabilities | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair value, net asset (liability) | 262 | |||
Level 1 | Fair value measurements on recurring basis | Restricted Cash | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair value, net asset (liability) | 1,038 | |||
Level 1 | Fair value measurements on recurring basis | Cash and cash equivalents | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair value, net asset (liability) | $ 29,667 | $ 57,336 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Asset Retirement Obligations (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Asset Retirement Obligation [Abstract] | ||
Asset retirement obligations at beginning of period | $ 2,179 | $ 2,081 |
Additional asset retirement obligations during the period | 8 | |
Amortization of interest on asset retirement obligations | 130 | 125 |
Effects of exchange rate on asset retirement obligations | 10 | (133) |
Asset retirement obligations at end of period | $ 2,319 | $ 2,081 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Anti-dilutive Securities Excluded from EPS (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earning per share, amount | 11,867,971 | 9,288,778 |
Share options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earning per share, amount | 8,307,672 | 6,968,181 |
Restricted share units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earning per share, amount | 2,661,250 | 2,182,500 |
Deferred share units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earning per share, amount | 185,000 | 110,000 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earning per share, amount | 700,000 | |
Restricted ordinary shares subject to forfeiture | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earning per share, amount | 14,049 | 28,097 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Non-Current Assets by Geographical Area (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Non-current assets | $ 154,878 | $ 156,170 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Non-current assets | 12,002 | 14,382 |
United Kingdom | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Non-current assets | 33,585 | 36,775 |
European Union | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Non-current assets | $ 109,291 | $ 105,013 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Additional Information (Details) | Sep. 30, 2023 |
Janssen Pharmaceuticals Inc | |
Percentage of research and development costs covered by Janssen | 100% |
Equity Method and Other Inves_3
Equity Method and Other Investments - Summary of Investments (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Schedule of Equity Method Investments [Line Items] | |
Carrying Value | $ 6,326 |
Cost Basis | $ 6,665 |
Visiogene LLC | |
Schedule of Equity Method Investments [Line Items] | |
Ownership percentage | 25% |
Carrying Value | $ 5,156 |
Cost Basis | 5,165 |
Other Investments | |
Schedule of Equity Method Investments [Line Items] | |
Carrying Value | 1,170 |
Cost Basis | $ 1,500 |
Ownership Percentage, other investments | 1.60% |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
Clinical trial costs | $ 10,827 | $ 13,041 |
Interest on Tranche 1 Notes | 2,898 | |
Research and development | 4,735 | 7,400 |
Compensation and benefits | 2,593 | 4,326 |
Manufacturing costs | 2,447 | 732 |
Professional fees | 1,773 | 9,600 |
Consulting | 1,468 | 3,093 |
Fixed assets | 1,278 | 694 |
Other | 232 | 932 |
Accrued expenses | $ 28,251 | $ 39,818 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Company's Share Option Activity (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Number of Options | ||
Number of options, Beginning balance | 6,858,409 | |
Number of options, Granted | 1,591,840 | |
Number of options, Forfeited | (142,577) | |
Number of options, Ending balance | 8,307,672 | 6,858,409 |
Weighted-Average Exercise Price | ||
Weighted-average exercise price, Beginning balance | $ 14.03 | |
Weighted-average exercise price, Granted | 8.49 | |
Weighted-average exercise price, Forfeited | 15.90 | |
Weighted-average exercise price, Ending balance | $ 12.95 | $ 14.03 |
Options additional disclosures | ||
Number of options, Options exercisable | 5,484,586 | |
Weighted-average exercise price, Options exercisable | $ 13.12 | |
Weighted-average remaining contractual life of options, outstanding | 6 years 7 months 24 days | 6 years 10 months 9 days |
Weighted-average remaining contractual life of options, exercisable | 5 years 7 months 13 days | |
Aggregate intrinsic value, options outstanding | $ 790 | |
Aggregate intrinsic value, options exercisable | $ 790 |
Share-Based Compensation - Sche
Share-Based Compensation - Schedule of Grant Date Fair Values of the Share Options Granted Black-Scholes Valuation Model (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | |
Share options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 3.86% | 1.56% |
Risk-free interest rate, maximum | 4.48% | 3.37% |
Expected volatility | 72% | 80% |
Expected dividend yield | 0% | 0% |
Share options | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 3 years 7 months 6 days | 5 years 6 months |
Share options | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Restricted Share Units (Details) - Restricted share units | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Number of restricted share units | |
Number of restricted share units, Beginning balance | shares | 2,182,500 |
Number of restricted share units, Granted | shares | 1,097,500 |
Number of restricted share units, Vested | shares | (618,750) |
Number of restricted share units, Ending balance | shares | 2,661,250 |
Weighted-average grant date fair value | |
Weighted-average grant date fair value, Beginning balance | $ / shares | $ 18.59 |
Weighted-average grant date fair value, Granted | $ / shares | 7.05 |
Weighted-average grant date fair value, Vested | $ / shares | 15.17 |
Weighted-average grant date fair value, Ending balance | $ / shares | $ 14.63 |
Share-Based Compensation - Sc_2
Share-Based Compensation - Schedule of Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Expense [Line Items] | ||||
Total share-based compensation | $ 7,053 | $ 6,937 | $ 20,756 | $ 21,818 |
Research and Development Expenses | ||||
Share Based Compensation Expense [Line Items] | ||||
Total share-based compensation | 3,250 | 3,482 | 9,569 | 10,780 |
General and Administrative Expenses | ||||
Share Based Compensation Expense [Line Items] | ||||
Total share-based compensation | $ 3,803 | $ 3,455 | $ 11,187 | $ 11,038 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares | Dec. 31, 2022 USD ($) shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted-average remaining contractual life of options, outstanding | 6 years 7 months 24 days | 6 years 10 months 9 days | |||
Fair value of options, Vested | $ 2,800 | $ 2,600 | $ 12,500 | $ 13,600 | |
Weighted-average grant date fair value of options granted | $ / shares | $ 5.67 | $ 13.07 | |||
Total share-based compensation | 7,053 | 6,937 | $ 20,756 | $ 21,818 | |
Excess tax benefits in cash flows from operations | $ 0 | 0 | |||
Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted-average remaining contractual life of options, outstanding | 10 years | ||||
General and Administrative Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total share-based compensation | 3,803 | 3,455 | $ 11,187 | 11,038 | |
Research and Development Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total share-based compensation | 3,250 | 3,482 | $ 9,569 | 10,780 | |
Restricted share units | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Period expected to realize unrecognized compensation expense | 3 years 4 months 24 days | ||||
Total compensation expense not yet recognized relating to unvested RSUs | 25,300 | $ 25,300 | |||
Total share-based compensation | 3,600 | 3,200 | $ 10,500 | 9,500 | |
Withheld ordinary shares | shares | 237,859 | 128,812 | |||
Taxes withheld on issuance of share-based awards | $ 1,500 | $ 2,800 | |||
Restricted share units | General and Administrative Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total share-based compensation | 2,500 | 2,200 | 7,300 | 6,700 | |
Restricted share units | Research and Development Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total share-based compensation | 1,100 | 1,000 | 3,200 | 2,800 | |
Share options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total unvested options compensation expense not yet recognized | 22,000 | $ 22,000 | |||
Period expected to realize unrecognized compensation expense | 4 years | ||||
Total share-based compensation | 3,500 | 3,800 | $ 10,300 | 12,300 | |
Share options | General and Administrative Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total share-based compensation | 1,300 | 1,300 | 3,900 | 4,300 | |
Share options | Research and Development Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total share-based compensation | $ 2,200 | $ 2,500 | $ 6,400 | $ 8,000 | |
Director [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 36 months | ||||
Two Participants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of participants in share-based compensation plan | 2 | 2 | 2 | 2 | |
Modifications to share-based compensation | $ 40 | $ 100 | |||
Two Participants | General and Administrative Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Modifications to share-based compensation | 30 | 50 | |||
Two Participants | Research and Development Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Modifications to share-based compensation | $ 10 | $ 80 | |||
Three Participants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of participants in share-based compensation plan | 3 | 3 | |||
Modifications to share-based compensation | $ 300 | ||||
Three Participants | General and Administrative Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Modifications to share-based compensation | 100 | ||||
Three Participants | Research and Development Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Modifications to share-based compensation | $ 200 | ||||
Six Participants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of participants in share-based compensation plan | 6 | 6 | |||
Modifications to share-based compensation | $ 300 | ||||
Six Participants | General and Administrative Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Modifications to share-based compensation | 200 | ||||
Six Participants | Research and Development Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Modifications to share-based compensation | $ 100 | ||||
First Anniversary [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 25% | ||||
Second Anniversary [Member] | Restricted share units | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 50% | ||||
Third Anniversary [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 25% | ||||
Fourth Anniversary [Member] | Restricted share units | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 25% | ||||
Over Three Years [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 36 months |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Jun. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Taxes | |||
Foreign currency translation, tax | $ 4,003 | ||
Provision for income taxes | $ 0 | $ 0 |
Related Party Transactions - Co
Related Party Transactions - Collaboration and License Agreements (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
May 03, 2023 | Nov. 09, 2022 | Jan. 30, 2019 | Dec. 31, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2019 | Dec. 31, 2022 | Feb. 27, 2019 | |
Related Party Transaction [Line Items] | ||||||||||||
Common stock, shares issued | 59,597,151 | 59,597,151 | 48,477,209 | |||||||||
Offering costs | $ 4,119 | |||||||||||
Shares issued to related party | 59,597,151 | 59,597,151 | 48,477,209 | |||||||||
Private Placement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Common stock, shares issued | 10,773,913 | |||||||||||
Proceeds from Issuance of Private Placement | $ 62,000 | |||||||||||
Offering costs | $ 4,100 | |||||||||||
Shares issued to related party | 10,773,913 | |||||||||||
JJDC | Private Placement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Common stock, shares issued | 3,742,514 | 2,898,550 | ||||||||||
Proceeds from Issuance of Private Placement | $ 25,000 | |||||||||||
Shares issued to related party | 3,742,514 | 2,898,550 | ||||||||||
Purchase price per share | $ 6.68 | |||||||||||
Janssen Pharmaceuticals Inc | Collaboration Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Collaboration agreement upfront payment | $ 100,000 | |||||||||||
Milestone payments received | $ 30,000 | |||||||||||
Deferred revenue - related party recognized as license revenue | $ 5,100 | $ 4,800 | $ 11,977 | $ 21,200 | ||||||||
Reimbursement of research and development expenses | 16,200 | $ 24,100 | $ 60,600 | $ 53,400 | ||||||||
Estimated period to recognize remaining deferred revenue | 3 years | |||||||||||
Remaining deferred revenue | $ 31,100 | $ 31,100 | ||||||||||
Janssen Pharmaceuticals Inc | Research, development and commercialization of gene therapies | Collaboration Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Collaboration agreement upfront payment | $ 100,000 | |||||||||||
Janssen Pharmaceuticals Inc | Clinical IRD Product Candidate development | Collaboration Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Milestone payments received | $ 30,000 | |||||||||||
Percentage of clinical and commercialization costs to be paid by related party | 100% | |||||||||||
Royalties receivable, as a percentage | 20% | |||||||||||
Janssen Pharmaceuticals Inc | Clinical IRD Product Candidate development | Collaboration Agreement | Maximum | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Milestone payments | $ 340,000 |
Related Party Transactions - Pe
Related Party Transactions - Performance Obligation (Details) $ in Millions | Sep. 30, 2023 USD ($) |
Collaboration Agreement | Janssen Pharmaceuticals Inc | |
Related Party Transaction [Line Items] | |
Revenue, Remaining Performance Obligation, Amount | $ 31.1 |
Related Party Transactions - Fi
Related Party Transactions - Financing Agreement (Details) - USD ($) $ in Thousands | 9 Months Ended | |||
May 03, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 19, 2022 | |
Related Party Transaction [Line Items] | ||||
Common stock, shares issued | 59,597,151 | 48,477,209 | ||
Offering costs | $ 4,119 | |||
Private Placement | ||||
Related Party Transaction [Line Items] | ||||
Common stock, shares issued | 10,773,913 | |||
Proceeds from Issuance of Private Placement | $ 62,000 | |||
Offering costs | $ 4,100 | |||
Perceptive Advisors, LLC | Private Placement | Common Stock [Member] | ||||
Related Party Transaction [Line Items] | ||||
Common stock, shares issued | 4,347,826 | |||
Perceptive Advisors, LLC | Secured Financing Agreement | ||||
Related Party Transaction [Line Items] | ||||
Equity ownership in outstanding ordinary shares | 10% | |||
Adage Capital Partners, L.P. | Common Stock [Member] | Minimum | ||||
Related Party Transaction [Line Items] | ||||
Third-party equity ownership in outstanding ordinary shares | 5% | |||
Adage Capital Partners, L.P. | Private Placement | Common Stock [Member] | ||||
Related Party Transaction [Line Items] | ||||
Common stock, shares issued | 1,565,217 |
Related Party Transactions - Le
Related Party Transactions - Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||||
Operating lease rent expenses | $ 1,400 | $ 1,300 | $ 4,100 | $ 4,000 | |
Other current liabilities | 2,476 | 2,476 | $ 6,631 | ||
Cash paid | $ 1,407 | $ 1,309 | $ 4,233 | $ 4,044 |
Related Party Transactions - Re
Related Party Transactions - Revenue Recognition (Details) - Janssen Pharmaceuticals Inc - Collaboration Agreement - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transaction [Line Items] | ||||
Deferred revenue at the beginning | $ 42,559 | |||
Deferred revenue recognized as license revenue during period | $ (5,100) | $ (4,800) | (11,977) | $ (21,200) |
Effects of exchange rate | 531 | |||
Deferred revenue at the end | $ 31,113 | $ 31,113 |
Leases - Schedule of Components
Leases - Schedule of Components of Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases | ||||
Amortization of right-of-use assets | $ 274 | $ 257 | $ 838 | $ 825 |
Interest on lease liabilities | 1 | |||
Total finance lease cost | 274 | 257 | 838 | 826 |
Operating lease cost | 1,371 | 1,311 | 4,103 | 3,986 |
Short-term lease cost | 40 | 39 | 119 | 115 |
Total lease cost | $ 1,685 | $ 1,607 | $ 5,060 | $ 4,927 |
Leases - Schedule of Consolidat
Leases - Schedule of Consolidated Balance Sheets for Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Operating leases | ||
Right-of-use asset | $ 17,446 | $ 20,109 |
Capitalized lease obligations | $ 18,348 | $ 21,215 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | mgtx:LeaseObligationsNonCurrent | mgtx:LeaseObligationsNonCurrent |
Finance leases | ||
Right-of-use asset | $ 23,680 | $ 24,718 |
Weighted-average remaining lease term | ||
Operating leases | 5 years | 5 years 7 months 6 days |
Finance leases | 175 years 1 month 6 days | 175 years 9 months 18 days |
Weighted-average discount rate | ||
Operating leases | 8.80% | 8.80% |
Finance leases | 8% | 8% |
Leases - Schedule of Other Info
Leases - Schedule of Other Information Related to Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Cash paid for amounts included in the measurement of lease liabilities | ||||
Operating cash flows from finance leases | $ 4 | $ 11 | ||
Operating cash flows from operating leases | $ 1,407 | $ 1,309 | $ 4,233 | 4,044 |
Right-of-use assets obtained in exchange for lease liabilities | ||||
Right-of-use assets obtained in exchange for lease liabilities | $ 1,793 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments Under Non-Cancellable Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Operating Leases | ||
2023 | $ 1,409 | |
2024 | 5,472 | |
2025 | 5,436 | |
2026 | 5,169 | |
2027 | 1,844 | |
Thereafter | 2,876 | |
Total undiscounted lease payments | 22,206 | |
Less: Imputed interest | (3,858) | |
Operating lease liability | $ 18,348 | $ 21,215 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Lessee, Lease, Description [Line Items] | |||||
Operating lease rent expenses | $ 1,400 | $ 1,300 | $ 4,100 | $ 4,000 | |
Right-of-use asset | 17,446 | 17,446 | $ 20,109 | ||
Operating lease liability | $ 18,348 | $ 18,348 | $ 21,215 | ||
Land and Building [Member] | |||||
Lessee, Lease, Description [Line Items] | |||||
Number of operating leases | 3 | 3 | |||
Right-of-use asset | $ 1,800 | $ 1,800 | |||
Operating lease liability | $ 1,800 | $ 1,800 | |||
Minimum | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease term | 3 years | ||||
Minimum | Land and Building [Member] | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease, term of contract | 3 years | 3 years | |||
Maximum | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease term | 191 years | ||||
Maximum | Land and Building [Member] | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease, term of contract | 9 years | 9 years |
Debt Financing (Details)
Debt Financing (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Aug. 02, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Line of Credit Facility [Line Items] | ||||||
Common stock, shares issued | 59,597,151 | 59,597,151 | 48,477,209 | |||
Perceptive Credit Holdings | Note Purchase Agreement | ||||||
Line of Credit Facility [Line Items] | ||||||
Unamortized debt discount, warrants | $ 2,300,000 | $ 2,300,000 | ||||
Unamortized debt discount, legal costs | 2,100,000 | 2,100,000 | ||||
Unamortized debt discount, gross | 4,400,000 | 4,400,000 | ||||
Amortization of debt discount | 300,000 | $ 200,000 | 800,000 | $ 200,000 | ||
Remaining unamortized discount on debt, total | 3,200,000 | 3,200,000 | ||||
Perceptive Credit Holdings | Note Purchase Agreement | Exercise Price - Scenario I | ||||||
Line of Credit Facility [Line Items] | ||||||
Shares available through warrants | $ 400,000 | |||||
Warrant exercise price | $ 15 | |||||
Perceptive Credit Holdings | Note Purchase Agreement | Exercise Price - Scenario II | ||||||
Line of Credit Facility [Line Items] | ||||||
Shares available through warrants | $ 300,000 | |||||
Warrant exercise price | $ 20 | |||||
Perceptive Credit Holdings | Note Purchase Agreement | Term Loan | ||||||
Line of Credit Facility [Line Items] | ||||||
Initial face amount | $ 75,000,000 | |||||
Unused borrowing capacity | $ 25,000,000 | |||||
Term loan outstanding amount | $ 75,000,000 | $ 75,000,000 | ||||
Interest rate at period-end | 15.12% | 15.12% | ||||
Increase in accrued interest | $ 2,900,000 | |||||
Interest expense on debt | $ 2,900,000 | $ 1,500,000 | 8,400,000 | $ 1,500,000 | ||
Obligations secured by UK and Ireland subsidiaries | 3,000,000 | 3,000,000 | ||||
Cash liquidity requirement | $ 3,000,000 | $ 3,000,000 | ||||
Perceptive Credit Holdings | Note Purchase Agreement | Term Loan | Base variable rate | ||||||
Line of Credit Facility [Line Items] | ||||||
Stated interest rate | 10% | |||||
Perceptive Credit Holdings | Note Purchase Agreement | Term Loan | SOFR | ||||||
Line of Credit Facility [Line Items] | ||||||
Floor percentage | 1% | |||||
SOFR adjustment term | 1 month |
Commitments and Contingencies (
Commitments and Contingencies (Details) | Sep. 30, 2023 |
Commitments and Contingencies | |
Number of new material commitments | 0 |
Subsequent Event - (Details)
Subsequent Event - (Details) - Private Placement - USD ($) $ / shares in Units, $ in Millions | Oct. 30, 2023 | May 03, 2023 |
Subsequent Event [Line Items] | ||
Proceeds from Issuance of Private Placement | $ 62 | |
Subsequent Events | Investment Agreement | Sanofi Foreign Participations B.V. | ||
Subsequent Event [Line Items] | ||
Shares issued and sold | 4,000,000 | |
Purchase price per share | $ 7.50 | |
Proceeds from Issuance of Private Placement | $ 30 | |
Period to list shares for resale | 24 months |