0001558370-22-017417 | 10-Q | XBRL Viewer

Leases - Schedule of Components of Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Leases [Abstract]
Amortization of right-of-use assets	$ 257	$ 305	$ 825	$ 927
Interest on lease liabilities			1	1
Total finance lease cost	257	305	826	928
Operating lease cost	1,311	1,293	3,986	3,715
Short-term lease cost	39	182	115	640
Total lease cost	$ 1,607	$ 1,780	$ 4,927	$ 5,283

Leases - Schedule of Other Information Related to Leases (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from finance leases	$ 4	$ 4	$ 11	$ 12
Operating cash flows from operating leases	$ 1,309	$ 1,234	4,044	3,678
Financing cash flows from finance leases				1
Right-of-use assets obtained in exchange for lease liabilities
Operating leases			$ 1,793	$ 4,424

Subsequent Event - (Details) - Subsequent Events - Johnson & Johnson (JJDC) - Securities Purchase Agreement - Private Placement $ / shares in Units, $ in Millions	Nov. 09, 2022 USD ($) $ / shares shares
Subsequent Event [Line Items]
Shares issued and sold \| shares	3,742,514
Purchase price per share \| $ / shares	$ 6.68
Proceeds from Issuance of Private Placement \| $	$ 25.0
Period to list shares for resale	180 days

Leases - Additional Information (Details) $ in Thousands	3 Months Ended		9 Months Ended
Leases - Additional Information (Details) $ in Thousands	Sep. 30, 2022 USD ($) lease	Sep. 30, 2021 USD ($)	Sep. 30, 2022 USD ($) lease	Sep. 30, 2021 USD ($)	Dec. 31, 2021 USD ($)
Lessee, Lease, Description [Line Items]
Operating lease rent expenses	$ 1,300	$ 1,300	$ 4,000	$ 3,700
Right-of-use asset	19,913		19,913		$ 22,782
Operating lease liability	21,117		21,117		$ 23,721
Vivarium Space
Lessee, Lease, Description [Line Items]
Short term lease commitments monthly amount	$ 10		$ 10
Number of short term leases \| lease			1
Operating lease, term of contract	1 year		1 year
Janssen Pharmaceuticals Inc
Lessee, Lease, Description [Line Items]
Number of operating leases \| lease	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 \| Janssen Pharmaceuticals Inc
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 \| Janssen Pharmaceuticals Inc
Lessee, Lease, Description [Line Items]
Operating lease, term of contract	9 years		9 years

Financing Agreement (Details) - Perceptive Credit Holdings - Secured Debt Agreement - USD ($)	9 Months Ended
	Sep. 30, 2022	Aug. 02, 2022
Line of Credit Facility [Line Items]
Cash liquidity requirement	$ 3,000,000.0
Term Loan
Line of Credit Facility [Line Items]
Term loan outstanding amount	$ 75,000,000.0
Interest rate at period-end	13.04%
Increase in accrued interest	$ 1,600,000
Debt discount, gross	4,300,000
Unamortized debt discount, warrants	2,300,000
Unamortized debt discount, legal costs	2,100,000
Amortization of discount on debt	200,000
Unamortized discount on debt, total	4,200,000
Term Loan \| Exercise Price - Scenario I
Line of Credit Facility [Line Items]
Shares available through warrants	$ 400,000
Warrant exercise price	$ 15.00
Term Loan \| Exercise Price - Scenario II
Line of Credit Facility [Line Items]
Shares available through warrants	$ 300,000
Warrant exercise price	$ 20.00
Term Loan \| Base variable rate
Line of Credit Facility [Line Items]
Stated interest rate	10.00%
Term Loan \| SOFR
Line of Credit Facility [Line Items]
Floor percentage	1.00%
SOFR adjustment term	1 month
Term Loan - Tranche I
Line of Credit Facility [Line Items]
Initial face amount		$ 75,000,000.0
Term Loan - Tranche II
Line of Credit Facility [Line Items]
Unused borrowing capacity		$ 25,000,000.0

Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Non-Current Assets by Geographical Area (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Operation By Geographical [Line Items]
Non-current assets	$ 146,376	$ 136,921
United States
Operation By Geographical [Line Items]
Non-current assets	21,802	23,636
United Kingdom
Operation By Geographical [Line Items]
Non-current assets	35,529	43,349
European Union
Operation By Geographical [Line Items]
Non-current assets	$ 89,045	$ 69,936

Related-Party Transactions - Financing Agreement (Details)	Aug. 02, 2022
Perceptive Advisors, LLC \| Secured Financing Agreement
Related Party Transaction [Line Items]
Equity ownership in outstanding ordinary shares	15.60%

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Common stock, par value	$ 0.00003881	$ 0.00003881
Common stock, shares authorized	1,288,327,750	1,288,327,750
Common stock, shares issued	44,725,678	44,548,925
Common stock, shares outstanding	44,710,678	44,548,925

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses for the periods presented are comprised of the following (in thousands):


	September 30,		December 31,
	2022		2021
Clinical trial costs	$	17,627	$	12,524
Manufacturing costs		1,471		2,889
Fixed assets		1,304		2,077
Compensation and benefits		1,516		6,029
Professional fees		1,156		1,018
Consulting		1,120		858
Research and development		180		1,735
Other		400		456
	$	24,774	$	27,586

Related-Party Transactions - Collaboration and License Agreements (Details) - USD ($) $ in Thousands		3 Months Ended		9 Months Ended		12 Months Ended
	Jan. 30, 2019	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021	Dec. 31, 2019	Feb. 27, 2019
Related Party Transaction [Line Items]
Shares issued to related party		44,725,678		44,725,678		44,548,925
Clinical IRD Product Candidate development \| Maximum
Related Party Transaction [Line Items]
Additional development and commercialization milestones	$ 340,000
Clinical IRD Product Candidate development \| Collaboration Agreement
Related Party Transaction [Line Items]
Royalties receivable, as a percentage	20.00%
JJDC \| Private Placement
Related Party Transaction [Line Items]
Shares issued to related party								2,898,550
Janssen Pharmaceuticals Inc \| Collaboration Agreement
Related Party Transaction [Line Items]
Collaboration agreement upfront payment							$ 100,000
Milestone payments						$ 30,000
Deferred revenue - related party recognized as license revenue		$ 4,800	$ 6,900	$ 21,208	$ 16,700	$ 37,701
Reimbursement of research and development expenses		24,100	$ 16,900	$ 53,400	$ 47,100
Estimated period to recognize remaining deferred revenue				3 years 2 months 12 days
Remaining deferred revenue		$ 34,400		$ 34,400
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]
Percentage of clinical and commercialization costs to be paid by related party	100.00%
Janssen Pharmaceuticals Inc \| Research IRD Candidates development \| Collaboration Agreement
Related Party Transaction [Line Items]
Percentage of clinical and commercialization costs to be paid by related party	100.00%

Share-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted-average remaining contractual life of options, outstanding			7 years 29 days		7 years 4 months 24 days
Fair value of options, Vested	$ 2,600	$ 2,500	$ 13,600	$ 12,200
Weighted-average grant date fair value of options granted			$ 13.07	$ 11.54
Total share-based compensation	6,937	5,339	$ 21,818	$ 15,359
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 Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation	3,455	2,903	$ 11,038	8,086
Research and Development Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation	3,482	2,436	$ 10,780	7,273
Restricted share units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Period expected to realize unrecognized compensation expense			3 years 3 months 18 days
Total compensation expense not yet recognized relating to unvested RSUs	29,900		$ 29,900
Total share-based compensation	3,200	1,700	$ 9,500	4,100
Withheld ordinary shares			128,812
Taxes withheld on issuance of share-based awards			$ 2,800	0
Restricted share units \| General and Administrative Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation	2,200	1,500	6,700	3,500
Restricted share units \| Research and Development Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation	1,000	200	2,800	600
Share Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total unvested options compensation expense not yet recognized	28,900		$ 28,900
Period expected to realize unrecognized compensation expense			3 years 11 months 8 days
Total share-based compensation	3,800	3,600	$ 12,300	11,300
Share Options \| General and Administrative Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation	1,300	1,400	4,300	4,600
Share Options \| Research and Development Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation	$ 2,500	$ 2,200	$ 8,000	$ 6,700
Director [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period			36 months
First Anniversary [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage			25.00%
Second Anniversary [Member] \| Restricted share units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage			50.00%
Third Anniversary [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage			25.00%
Fourth Anniversary [Member] \| Restricted share units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage			25.00%
Over Three Years [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period			36 months

Commitments

9 Months Ended

Sep. 30, 2022

Commitments

Commitments

10. Commitments

There were no new material commitments entered into during the nine-month period ended September 30, 2022.

Organization and Basis of Presentation

9 Months Ended

Sep. 30, 2022

Organization And Nature Of Business Textual [Abstract]

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. 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, 2022 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2022. 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, 2021 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (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, 2022 totaled $442.9 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, dependence on key personnel and the COVID-19 pandemic and mitigation measures. For the nine-months ended September 30, 2022, the Company used $56.8 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, 2022, the Company had cash and cash equivalents in the amount of $114.7 million, which consisted of depository accounts and money market accounts. 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, 2022, 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.

There are also many uncertainties regarding the pandemic caused by the novel coronavirus, or COVID-19, and the Company continues to closely monitor the impact of the pandemic on all aspects of its business, including how the pandemic will impact its financial condition, liquidity, operations, clinical studies, employees, vendors, and industry. While the pandemic did not materially affect the Company's financial results and business operations during the nine-month period ended September 30, 2022, the Company is unable to predict the impact that COVID-19 will have on its financial position and operating results in future periods due to numerous uncertainties. The Company will continue to assess the evolving impact of the COVID-19 pandemic and will make adjustments to its operations as necessary.

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 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 COVID-19 outbreak 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.

Financing Agreement

9 Months Ended

Sep. 30, 2022

Financing Agreement (Abstract)

Financing Agreement

9. Financing Agreement

On August 2, 2022 the Company, as borrower, and the Subsidiary Guarantors, entered into the Financing Agreement by and among the Company, the Subsidiary Guarantors, the lenders and other parties from time to time party thereto and Perceptive, as administrative agent and lender.

The Financing Agreement provides for an initial $75.0 million term loan (the “Initial Loan”), and the Company may request an additional $25.0 million term loan tranche to be made available at Perceptive’s sole discretion before August 2, 2024. The Financing Agreement matures on August 2, 2026 and is interest-only during the term. The Company has the option to prepay outstanding principal borrowings at any time along with an applicable early prepayment fee. Outstanding borrowings under the Financing Agreement bear interest at a fluctuating rate per annum equal to 10.00% plus the secured overnight financing rate administered by the Federal Reserve Bank of New York for a one-month tenor, subject to a 1.00% floor. The annual interest rate was 13.04% at September 30, 2022. As of September 30, 2022, the outstanding balance of the term loan was $75.0 million plus accrued interest of $1.6 million.

The Company’s obligations under the Financing 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 Financing 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, 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.

In connection with 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 Financing Agreement totaling $2.1 million, which were recorded as a discount to the loan. The aggregate discount of $4.3 million is being amortized to interest expense over the term of the Financing Agreement. The Company amortized $0.2 million of the discount to

interest expense during the three and nine months ended September 30, 2022. At September 30, 2022, the remaining unamortized discount was $4.2 million.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-URI https://asc.fasb.org/topic&trid=2208564

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 470
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Paragraph 1C
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-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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+ Details

Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Change in Asset Retirement Obligations (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Asset Retirement Obligation [Abstract]
Balance at beginning of period	$ 2,081	$ 1,814
Additional asset retirement obligations during the period	8
Amortization of interest	125	112
Effects of exchange rate	(133)	(10)
Balance at end of period	$ 2,081	$ 1,916

Equity Method and Other Investments (Details) - Visiogene LLC $ in Millions	Jan. 04, 2021 USD ($) shares
Schedule of Equity Method Investments [Line Items]
Number of preferred units acquired \| shares	3,000,000
Cash consideration	$ 5.0
Ordinary shares issued in connection with a license agreement (in shares) \| shares	75,000
Value of shares issued	$ 1.2
Visiogene License Agreement
Schedule of Equity Method Investments [Line Items]
Allocation of payments	1.0
Investment allocated amount expensed	1.0
Visiogene Unit Agreement
Schedule of Equity Method Investments [Line Items]
Allocation of payments	$ 5.2

Commitments (Details)	Sep. 30, 2022
Commitments
Number of new material commitments	0

Share-Based Compensation - Summary of Restricted Share Units (Details) - Restricted share units	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Number of restricted share units
Number of restricted share units, Beginning balance \| shares	1,415,000
Number of restricted share units, Granted \| shares	1,180,000
Number of restricted share units, Vested \| shares	(397,500)
Number of restricted share units, Forfeited \| shares	15,000
Number of restricted share units, Ending balance \| shares	2,182,500
Weighted-average grant date fair value
Weighted-average grant date fair value, Beginning balance \| $ / shares	$ 17.16
Weighted-average grant date fair value, Granted \| $ / shares	20.12
Weighted-average grant date fair value, Vested \| $ / shares	18.40
Weighted-average grant date fair value, Forfeited \| $ / shares	8.25
Weighted-average grant date fair value, Ending balance \| $ / shares	$ 18.59

Leases - Schedule of Consolidated Balance Sheets for Leases (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Operating leases
Right-of-use asset	$ 19,913	$ 22,782
Capitalized lease obligations	$ 21,117	$ 23,721
Operating Lease, Liability, Statement of Financial Position [Extensible List]	Liabilities	Liabilities
Finance leases
Right-of-use asset	$ 22,890	$ 27,645
Capitalized lease obligations		$ 12
Finance Lease, Liability, Statement of Financial Position [Extensible Enumeration]	Liabilities	Liabilities
Weighted-average remaining lease term
Operating leases	5 years 10 months 24 days	6 years 6 months
Finance leases	176 years	176 years 8 months 12 days
Weighted-average discount rate
Operating leases	8.50%	8.50%
Finance leases	8.00%	8.00%

Related-Party Transactions - Leases (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Related Party Transaction [Line Items]
Operating lease rent expenses	$ 1,300	$ 1,300	$ 4,000	$ 3,700
Cash paid	$ 1,309	1,234	$ 4,044	3,678
ARE East River Science Park LLC [Member] \| Vivarium Space Operating Lease
Related Party Transaction [Line Items]
Operating lease, term of contract	12 months		12 months
Cash paid	$ 40	10	$ 100	50
Amount due	0		0		$ 0
ARE East River Science Park LLC [Member] \| Vivarium Space Operating Lease \| Loss from operations
Related Party Transaction [Line Items]
Operating lease rent expenses	40	30	100	50
Kadmon Corporation LLC [Member] \| Loss from operations
Related Party Transaction [Line Items]
Operating lease rent expenses	$ 0	$ 200	$ 0	$ 500

- Definition

Carrying amount as of the balance sheet date of obligations due all related parties.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(k)(1))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126975872&loc=SL124442552-122756

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126734703&loc=d3e572229-122910

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 10
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-Paragraph 1
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=6457730&loc=d3e39549-107864

+ Details

Organization and Basis of Presentation - Additional Information (Details) $ in Thousands	1 Months Ended		9 Months Ended
	Dec. 31, 2021 USD ($)	Mar. 31, 2019 USD ($)	Sep. 30, 2022 USD ($) item Program	Sep. 30, 2021 USD ($)	Dec. 31, 2020 USD ($)
Schedule Of Description Of Business [Line Items]
Accumulated deficit	$ (340,589)		$ (442,891)
Cash flows from operations			(56,831)	$ (29,358)
Cash, cash equivalents	137,703		$ 114,706	$ 143,634	$ 209,520
Number of programs in clinical development \| Program			6
Number of distinct areas of unmet medical need \| item			3
Janssen Pharmaceuticals Inc \| Collaboration Agreement
Schedule Of Description Of Business [Line Items]
Collaboration agreement upfront payment		$ 100,000
Milestone payments	$ 30,000
Minimum
Schedule Of Description Of Business [Line Items]
Offsetting expense, period			12 months

Equity Method and Other Investments - Summary of Investments (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Schedule of Equity Method Investments [Line Items]
Carrying Value	$ 6,656
Cost Basis	$ 6,665
Ownership Percentage, other investments	3.00%
Carrying Value and cost other investments	$ 1,500
Total equity method and other investments	$ 6,656	$ 6,656
Visiogene LLC
Schedule of Equity Method Investments [Line Items]
Ownership percentage	25.00%
Carrying Value	$ 5,156
Cost Basis	$ 5,165

Equity Method and Other Investments (Tables)

9 Months Ended

Sep. 30, 2022

Long-term Investments [Abstract]

Schedule of Investments

The Company’s investments consist of the following (in thousands):


		September 30, 2022
Investee	Investment Type	Ownership Percentage		Carrying Value		Cost Basis
Visiogene LLC	Equity Method Investment	25	%	$	5,156	$	5,165
Other	Equity Investment	3	%		1,500		1,500
Total equity method and other investments				$	6,656	$	6,665

Income Taxes

9 Months Ended

Sep. 30, 2022

Income Tax Disclosure [Abstract]

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, 2022 and 2021, 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, 2022. 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.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
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-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Share-Based Compensation - Summary of Company's Share Option Activity (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Number of Options
Number of options, Beginning balance	5,924,690
Number of options, Granted	1,443,400
Number of options, Exercised	(18,065)
Number of options, Forfeited	(381,844)
Number of options, Ending balance	6,968,181	5,924,690
Weighted-Average Exercise Price
Weighted-average exercise price, Beginning balance	$ 13.16
Weighted-average exercise price, Granted	18.92
Weighted-average exercise price, Exercised	10.61
Weighted-average exercise price, Forfeited	17.90
Weighted-average exercise price, Ending balance	$ 14.12	$ 13.16
Options additional disclosures
Number of options, Options exercisable	4,388,802
Weighted-average exercise price, Options exercisable	$ 12.02
Weighted-average remaining contractual life of options, outstanding	7 years 29 days	7 years 4 months 24 days
Weighted-average remaining contractual life of options, exercisable	6 years 1 month 24 days
Aggregate intrinsic value, options outstanding	$ 3,825
Aggregate intrinsic value, options exercisable	$ 3,712

Leases (Tables)

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Schedule of Components of Lease Cost

The components of lease cost for the three-month and nine-month periods ended September 30, 2022 and 2021 are as follows (in thousands):


	Three-Month Period Ended September 30,
	2022		2021
Finance lease cost
Amortization of right-of-use assets	$	257	$	305
Interest on lease liabilities		—		—
Total finance lease cost		257		305
Operating lease cost		1,311		1,293
Short-term lease cost		39		182
Total lease cost	$	1,607	$	1,780


	Nine-Month Period Ended September 30,
	2022		2021
Finance lease cost
Amortization of right-of-use assets	$	825	$	927
Interest on lease liabilities		1		1
Total finance lease cost		826		928
Operating lease cost		3,986		3,715
Short-term lease cost		115		640
Total lease cost	$	4,927	$	5,283

Schedule of Consolidated Balance Sheets for Leases

Amounts reported in the condensed consolidated balance sheets for leases where the Company is the lessee as of September 30, 2022 and December 31, 2021 were as follows (in thousands):


	September 30,			December 31,
	2022			2021
Operating leases
Right-of-use asset	$	19,913		$	22,782
Capitalized lease obligations	$	21,117		$	23,721
Finance leases
Right-of-use asset	$	22,890		$	27,645
Capitalized lease obligations	$	—		$	12
Weighted-average remaining lease term
Operating leases		5.9	years		6.5	years
Finance leases		176.0	years		176.7	years
Weighted-average discount rate
Operating leases		8.5	%		8.5	%
Finance leases		8.0	%		8.0	%

Schedule of Other Information Related to Leases

Other information related to leases for the three-month and nine-month periods ended September 30, 2022 and 2021 are as follows (in thousands):


	Three-Month Period Ended September 30,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from finance leases	$	4	$	4
Operating cash flows from operating leases	$	1,309	$	1,234
Financing cash flows from finance leases	$	—	$	—

Right-of-use assets obtained in exchange for lease liabilities
Operating leases	$	—	$	—
Finance leases	$	—	$	—


	Nine-month periods ended September 30,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from finance leases	$	11	$	12
Operating cash flows from operating leases	$	4,044	$	3,678
Financing cash flows from finance leases	$	—	$	1

Right-of-use assets obtained in exchange for lease liabilities
Operating leases	$	1,793	$	4,424
Finance leases	$	—	$	—

Schedule of Future Minimum Lease Payments Under Non-Cancellable Leases

Future minimum lease payments under non-cancellable leases as of September 30, 2022 are as follows (in thousands):


	Operating Leases		Finance Leases
2022	$	1,311	$	—
2023		5,353		—
2024		5,237		—
2025		5,207		—
2026		4,912		—
Thereafter		4,313		—
Total undiscounted lease payments	$	26,333	$	—
Less: Imputed interest		(5,216)		—
Total lease liabilities	$	21,117	$	—

Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Company's Financial Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Other long-term liabilities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value, net asset (liability)	$ 338	$ 953
Cash and cash equivalents
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value, net asset (liability)	77,907	66,585
Fair Value, Inputs, Level 1 [Member] \| Other long-term liabilities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value, net asset (liability)	338	953
Fair Value, Inputs, Level 1 [Member] \| Cash and cash equivalents
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value, net asset (liability)	$ 77,907	$ 66,585

Related-Party Transactions (Tables)

9 Months Ended

Sep. 30, 2022

Summary of the Deferred Revenue Recognition

A summary of the deferred revenue recognition is as follows (in thousands):


Deferred revenue at December 31, 2020	$	72,842
Milestone payment from Janssen		30,000
Deferred revenue recognized as license revenue during the year ended December 31, 2021		(37,701)
Effects of exchange rate changes		(275)
Deferred revenue at December 31, 2021		64,866
Deferred revenue recognized as license revenue during the nine-month period ended September 30, 2022		(21,208)
Effects of exchange rate changes		(9,294)
Deferred revenue at September 30, 2022	$	34,364

Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables)

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Schedule of Company's Financial Assets and Liabilities Measured at Fair Value

The table below represents the values of the Company's financial assets and liabilities that are required to be measured at fair value on a recurring basis (in thousands):


	Fair Value Measurement Using:
			Significant		Significant Other		Significant
	September 30,		Observable Inputs		Observable Inputs		Unobservable
Description	2022		(Level 1)		(Level 2)		(Level 3)
Cash and cash equivalents	$	77,907	$	77,907	$	—	$	—
Other long-term liabilities	$	338	$	338	$	—	$	—


	Fair Value Measurement Using:
			Significant		Significant Other		Significant
	December 31,		Observable Inputs		Observable Inputs		Unobservable
Description	2021		(Level 1)		(Level 2)		(Level 3)
Cash and cash equivalents	$	66,585	$	66,585	$	—	$	—
Other long-term liabilities	$	953	$	953	$	—	$	—

Schedule of Change in Asset Retirement Obligations

The change in asset retirement obligations is as follows (in thousands):


	For the Nine-Month Period Ended September 30,
	2022		2021
Balance at beginning of period	$	2,081	$	1,814
Additional asset retirement obligations during the period		8		—
Amortization of interest		125		112
Effects of exchange rate changes		(133)		(10)
Balance at end of period	$	2,081	$	1,916

Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share


	September 30,	September 30,
	2022	2021
Share options	6,968,181	6,141,510
Restricted share units	2,182,500	1,415,000
Restricted ordinary shares subject to forfeiture	28,097	145,000
	9,178,778	7,701,510

Summary of Non-Current Assets by Geographical Area

The following table summarizes long-lived assets by geographical area (in thousands):


	September 30,		December 31,
	2022		2021
United States	$	21,802	$	23,636
United Kingdom		35,529		43,349
European Union		89,045		69,936
	$	146,376	$	136,921

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
CURRENT ASSETS:
Cash and cash equivalents	$ 114,706	$ 137,703
Accounts receivable - related party	23,701	22,384
Prepaid expenses	10,171	8,102
Tax incentive receivable	4,897	12,634
Other current assets	1,561	2,420
Total Current Assets	155,036	183,243
Property, plant and equipment, net	93,620	75,860
Intangible assets, net	1,293	1,791
In-process research and development	682	783
Other assets	1,322	1,404
Equity method and other investments	6,656	6,656
Right-of-use assets - operating leases, net	19,913	22,782
Right-of-use assets - finance leases, net	22,890	27,645
TOTAL ASSETS	301,412	320,164
CURRENT LIABILITIES:
Accounts payable	21,693	15,348
Accrued expenses	24,774	27,586
Lease obligations, current	3,659	3,374
Deferred revenue - related party, current	18,878	21,820
Other current liabilities	3,359
Total Current Liabilities	72,363	68,128
Deferred revenue - related party	15,486	43,046
Lease obligations	17,458	20,359
Asset retirement obligations	2,081	2,081
Deferred income tax liability	171	196
Notes payables, net	70,845
Other long-term liabilities	338	953
TOTAL LIABILITIES	178,742	134,763
COMMITMENTS (Note 9)
SHAREHOLDERS' EQUITY:
Ordinary Shares, $0.00003881 par value, 1,288,327,750 authorized, 44,725,678 and 44,548,925 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	2	2
Capital in excess of par value	550,168	528,659
Accumulated other comprehensive income (loss)	15,391	(2,671)
Accumulated deficit	(442,891)	(340,589)
Total Shareholders' Equity	122,670	185,401
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY	$ 301,412	$ 320,164

Leases

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

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 $1.3 million and $1.3 million for the three-month periods ended September 30, 2022 and 2021, respectively.

Total rent expense under these leases was $4.0 million and $3.7 million for the nine-month periods ended September 30, 2022 and 2021, respectively.

As of September 30, 2022, the Company has short term lease commitments amounting to approximately $0.01 million on a monthly basis for one lease for vivarium space that is on a one-year lease.

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, 2022 and 2021 are as follows (in thousands):


	Three-Month Period Ended September 30,
	2022		2021
Finance lease cost
Amortization of right-of-use assets	$	257	$	305
Interest on lease liabilities		—		—
Total finance lease cost		257		305
Operating lease cost		1,311		1,293
Short-term lease cost		39		182
Total lease cost	$	1,607	$	1,780


	Nine-Month Period Ended September 30,
	2022		2021
Finance lease cost
Amortization of right-of-use assets	$	825	$	927
Interest on lease liabilities		1		1
Total finance lease cost		826		928
Operating lease cost		3,986		3,715
Short-term lease cost		115		640
Total lease cost	$	4,927	$	5,283

Amounts reported in the condensed consolidated balance sheets for leases where the Company is the lessee as of September 30, 2022 and December 31, 2021 were as follows (in thousands):


	September 30,			December 31,
	2022			2021
Operating leases
Right-of-use asset	$	19,913		$	22,782
Capitalized lease obligations	$	21,117		$	23,721
Finance leases
Right-of-use asset	$	22,890		$	27,645
Capitalized lease obligations	$	—		$	12
Weighted-average remaining lease term
Operating leases		5.9	years		6.5	years
Finance leases		176.0	years		176.7	years
Weighted-average discount rate
Operating leases		8.5	%		8.5	%
Finance leases		8.0	%		8.0	%

Other information related to leases for the three-month and nine-month periods ended September 30, 2022 and 2021 are as follows (in thousands):


	Three-Month Period Ended September 30,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from finance leases	$	4	$	4
Operating cash flows from operating leases	$	1,309	$	1,234
Financing cash flows from finance leases	$	—	$	—

Right-of-use assets obtained in exchange for lease liabilities
Operating leases	$	—	$	—
Finance leases	$	—	$	—


	Nine-month periods ended September 30,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from finance leases	$	11	$	12
Operating cash flows from operating leases	$	4,044	$	3,678
Financing cash flows from finance leases	$	—	$	1

Right-of-use assets obtained in exchange for lease liabilities
Operating leases	$	1,793	$	4,424
Finance leases	$	—	$	—

Future minimum lease payments under non-cancellable leases as of September 30, 2022 are as follows (in thousands):


	Operating Leases		Finance Leases
2022	$	1,311	$	—
2023		5,353		—
2024		5,237		—
2025		5,207		—
2026		4,912		—
Thereafter		4,313		—
Total undiscounted lease payments	$	26,333	$	—
Less: Imputed interest		(5,216)		—
Total lease liabilities	$	21,117	$	—

Share-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Disclosure of Compensation Related Costs, Share-based Payments [Abstract]

Summary of Company's Share Option Activity Related to Employees, Non-Employee Members of the Board of Directors and Non-Employee Consultants

A summary of the Company’s share option activity related to employees, non-employee members of the board of directors and non-employee consultants as of December 31, 2021 and for the nine-month period ended September 30, 2022 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, 2021		5,924,690	$	13.16	7.40	years
Granted		1,443,400	$	18.92
Exercised		(18,065)	$	10.61
Forfeited		(381,844)	$	17.90
Outstanding at September 30, 2022		6,968,181	$	14.12	7.08	years
Options exercisable at September 30, 2022		4,388,802	$	12.02	6.15	years
Aggregate intrinsic value of options outstanding as of September 30, 2022	$	3,825
Aggregate intrinsic value of options exercisable as of September 30, 2022	$	3,712

Summary of Company's RSU Activity Related to Employees, Non-Employee Members of the Board of Directors and Non-Employee Consultants


		Weighted-
	Number of	Average
	Restricted	Grant Date
	Share Units	Fair Value
Outstanding at December 31, 2021	1,415,000	$	17.16
Granted	1,180,000	$	20.12
Vested	(397,500)	$	18.40
Forfeited	(15,000)	$	8.25
Outstanding at September 30, 2022	2,182,500	$	18.59

Schedule of Inputs Used to Determine Fair Value of Share Options


	2022	2021
Risk-free interest rate	1.56 - 3.37%	0.62 - 1.14%
Expected volatility	80%	90%
Expected dividend yield	0%	0%
Expected term (in years)	5.5 - 6.1	5.5 - 6.1

Schedule of Share-Based Compensation Expense

During the nine-month period ended September 30, 2022 and 2021, 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,
	2022		2021
Research and development	$	3,482	$	2,436
General and administrative		3,455		2,903
Total share-based compensation	$	6,937	$	5,339


	Nine-Month Period Ended September 30,
	2022		2021
Research and development	$	10,780	$	7,273
General and administrative		11,038		8,086
Total share-based compensation	$	21,818	$	15,359

Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share (Details) - shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities excluded from computation of earning per share, amount	9,178,778	7,701,510
Share Options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities excluded from computation of earning per share, amount	6,968,181	6,141,510
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	2,182,500	1,415,000
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	28,097	145,000

Share-Based Compensation - Schedule of Share-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share Based Compensation Expense [Line Items]
Total share-based compensation	$ 6,937	$ 5,339	$ 21,818	$ 15,359
General and Administrative Expense [Member]
Share Based Compensation Expense [Line Items]
Total share-based compensation	3,455	2,903	11,038	8,086
Research and Development Expenses [Member]
Share Based Compensation Expense [Line Items]
Total share-based compensation	$ 3,482	$ 2,436	$ 10,780	$ 7,273

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2022	Oct. 31, 2022
Document And Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2022
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		44,725,678
Entity Central Index Key	0001735438
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Amendment Flag	false

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Statement [Abstract]
License revenue - related party	$ 4,816	$ 6,948	$ 21,208	$ 16,658
Operating expenses:
General and administrative	10,762	7,887	32,548	28,214
Research and development	16,862	21,613	63,960	53,512
Total operating expenses	27,624	29,500	96,508	81,726
Loss from operations	(22,808)	(22,552)	(75,300)	(65,068)
Other non-operating income (expense):
Foreign currency (loss) gain	(12,838)	(3,367)	(25,911)	(4,600)
Interest income	288	33	345	188
Interest expense	(1,892)	(59)	(2,051)	(169)
Fair value adjustment	(34)		615
Net loss	(37,284)	(25,945)	(102,302)	(69,649)
Other comprehensive income (loss):
Foreign currency translation gain (loss)	8,772	2,669	18,062	1,991
Total comprehensive loss	(28,512)	(23,276)	(84,240)	(67,658)
Net loss	$ (37,284)	$ (25,945)	$ (102,302)	$ (69,649)
Basic net loss per ordinary share	$ (0.83)	$ (0.59)	$ (2.29)	$ (1.58)
Diluted net loss per ordinary share	$ (0.83)	$ (0.59)	$ (2.29)	$ (1.58)
Weighted-average number of ordinary shares outstanding, basic	44,687,635	44,170,299	44,620,900	44,094,873
Weighted-average number of ordinary shares outstanding, diluted	44,687,635	44,170,299	44,620,900	44,094,873

Income Taxes - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Tax Disclosure [Abstract]
Provision for income taxes	$ 0	$ 0	$ 0	$ 0

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Accrued Expenses

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Accrued Expenses

4. Accrued Expenses

Accrued expenses for the periods presented are comprised of the following (in thousands):


	September 30,		December 31,
	2022		2021
Clinical trial costs	$	17,627	$	12,524
Manufacturing costs		1,471		2,889
Fixed assets		1,304		2,077
Compensation and benefits		1,516		6,029
Professional fees		1,156		1,018
Consulting		1,120		858
Research and development		180		1,735
Other		400		456
	$	24,774	$	27,586

Equity Method and Other Investments

9 Months Ended

Sep. 30, 2022

Long-term Investments [Abstract]

Equity Method and Other Investments

3. Equity Method and Other Investments

The Company’s investments consist of the following (in thousands):


		September 30, 2022
Investee	Investment Type	Ownership Percentage		Carrying Value		Cost Basis
Visiogene LLC	Equity Method Investment	25	%	$	5,156	$	5,165
Other	Equity Investment	3	%		1,500		1,500
Total equity method and other investments				$	6,656	$	6,665

Visiogene LLC

On January 4, 2021, the Company and Visiogene LLC (“Visiogene”) entered into a License and Investment Agreement (“Visiogene License Agreement”) for an exclusive, worldwide license to certain of Visiogene’s intellectual property relating to ocular gene therapy. Concurrently, the Company and Visiogene entered into a Preferred Unit Purchase Agreement (“Visiogene Unit Agreement”) pursuant to which the Company purchased 3,000,000 Visiogene preferred units. In connection with the two Visiogene agreements, the Company paid $5.0 million in cash and issued to Visiogene 75,000 ordinary shares of the Company with a fair market value of $1.2 million based on the closing price of the Company’s ordinary shares on the date of closing.

The Company accounted for the payments under the Visiogene License Agreement and Visiogene Unit Agreement as a basket transaction and allocated $1.0 million to the Visiogene License Agreement and the remaining $5.2 million was allocated to the Visiogene preferred units. The $1.0 million allocated to the Visiogene License Agreement was expensed as acquired in-process research and development as the Company determined there was no alternative future use. The Company accounts for this investment using the equity method of accounting.

Leases - Schedule of Future Minimum Lease Payments Under Non-Cancellable Leases (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Operating Leases
2022	$ 1,311
2023	5,353
2024	5,237
2025	5,207
2026	4,912
Thereafter	4,313
Total undiscounted lease payments	26,333
Less: Imputed interest	(5,216)
Operating lease liability	21,117	$ 23,721
Finance Leases
2024	0
2025	0
2026	0
Thereafter	$ 0
Finance lease liability		$ 12

Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies)

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

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.

Additionally, the Company has made estimates of the impact of the COVID-19 pandemic within the condensed consolidated financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates.

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, or ASC 820, for application to financial assets and liabilities. In addition to defining fair value, the standard expands the disclosure requirements around fair value and establishes a fair value hierarchy for valuation inputs. The hierarchy prioritizes the inputs into three levels based on the extent to which inputs used in measuring fair value are observable in the market. Each fair value measurement is reported in one of the three levels which are determined by the lowest level input that is significant to the fair value measurement in its entirety. These levels are:

●

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	2022		(Level 1)		(Level 2)		(Level 3)
Cash and cash equivalents	$	77,907	$	77,907	$	—	$	—
Other long-term liabilities	$	338	$	338	$	—	$	—


	Fair Value Measurement Using:
			Significant		Significant Other		Significant
	December 31,		Observable Inputs		Observable Inputs		Unobservable
Description	2021		(Level 1)		(Level 2)		(Level 3)
Cash and cash equivalents	$	66,585	$	66,585	$	—	$	—
Other long-term liabilities	$	953	$	953	$	—	$	—

At September 30, 2022, the Company's financial instruments included cash and cash equivalents, 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, 2022, the Company believed the carrying value of its Initial Loan (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 ASC 842. The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the Company has the right to control the use of the identified asset. The Company accounts for the lease and non-lease components as a single lease component.

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 are included 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,
	2022		2021
Balance at beginning of period	$	2,081	$	1,814
Additional asset retirement obligations during the period		8		—
Amortization of interest		125		112
Effects of exchange rate changes		(133)		(10)
Balance at end of period	$	2,081	$	1,916

Collaboration Arrangements

The Company evaluates its collaborative arrangements pursuant to ASC 808, Collaborative Arrangements (“ASC 808”) and ASC 606, Revenue from Contracts with Customers (“ASC 606”). The Company considers the nature and contractual terms of collaborative arrangements and assesses whether the arrangement involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards with respect to the arrangement. If the Company is an active participant and is exposed to significant risks and rewards with respect to the arrangement, the Company accounts for the arrangement as a collaboration under ASC 808. To date, the Company has entered into two separate collaboration agreements, both of which are with Janssen, which were determined to be within the scope of ASC 808.

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:

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

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. The reimbursement of the research and development costs by Janssen is representative of the joint risk sharing nature of the arrangement. The Company considered the guidance in ASC 808 and recognizes the payments received from Janssen as a reduction to research and development expense when the related costs are incurred.

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,
	2022	2021
Share options	6,968,181	6,141,510
Restricted share units	2,182,500	1,415,000
Restricted ordinary shares subject to forfeiture	28,097	145,000
	9,178,778	7,701,510

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,
	2022		2021
United States	$	21,802	$	23,636
United Kingdom		35,529		43,349
European Union		89,045		69,936
	$	146,376	$	136,921

Recent Accounting Pronouncements Not Yet Adopted

Recent Accounting Pronouncements Adopted

In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. The guidance is effective for fiscal years beginning on or after December 15, 2021, with early adoption permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company adopted the new standard as of January 1, 2022. The adoption of the standard had no material impact.

Recent Accounting Pronouncements Not Yet Adopted

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which adds a new Topic 326 to the Codification and removes the thresholds that companies apply to measure credit losses on financial instruments measured at amortized cost, such as loans, receivables, and held-to-maturity debt securities. Under current GAAP, companies generally recognize credit losses when it is probable that the loss has been incurred. The revised guidance will remove all recognition thresholds and will require companies to recognize an allowance for credit losses for the difference between the amortized cost basis of a financial instrument and the amount of amortized cost that the Company expects to collect over the instrument’s contractual life. ASU 2016-13 also amends the credit loss measurement guidance for available-for-sale debt securities and beneficial interests in securitized financial assets. The guidance is applicable for fiscal years beginning after December 15, 2019 and interim periods within those years, however, the FASB extended the effective date for smaller reporting companies to fiscal years beginning after December 15, 2022. The Company is currently evaluating the potential impact of the adoption of this standard on its related disclosures.

Related-Party Transactions - Revenue Recognition (Details) - Janssen Pharmaceuticals Inc - Collaboration Agreement - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Related Party Transaction [Line Items]
Deferred revenue at the beginning			$ 64,866	$ 72,842	$ 72,842
Milestone payments					30,000
Deferred revenue recognized as license revenue during period	$ (4,800)	$ (6,900)	(21,208)	$ (16,700)	(37,701)
Effects of exchange rate			(9,294)		(275)
Deferred revenue at the end	$ 34,364		$ 34,364		$ 64,866

Related-Party Transactions

9 Months Ended

Sep. 30, 2022

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”). The parties will select and prioritize the Research IRD Product Candidates and Janssen has the right to 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.

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.

Research IRD Product Candidates

Under the Collaboration Agreement, the Company and Janssen will collaborate to develop Research IRD Product Candidates, with Janssen paying for the majority of the research costs. Janssen has the right to exclusively license any product coming out of the collaboration at the time of an investigational new drug application (“IND”) for an additional fee for each Research IRD Product Candidate. Janssen will then pay 100% of the clinical and commercialization costs for these Research IRD Product Candidates and the Company will receive an untiered royalty on net sales in the high teens as well as development milestones for each Research IRD Product Candidate.

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 and the Company will account for these options as separate contracts when and if Janssen elects to exercise the options.

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 are accounted for separately as they do not represent material rights, based on the criteria of ASC 606. Upon the exercise of any purchased option by Janssen, the contract promises associated with an Option Target would use a separate cost-to-cost model for purposes of revenue recognition under 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, 2022 and 2021, the Company recognized $4.8 million and $6.9 million, respectively, of the deferred revenue – related party as license revenue.

During the nine-month periods ended September 30, 2022 and 2021, the Company recognized $21.2 million and $16.7 million, respectively, of the deferred revenue – related party as license revenue.

The Company also recognized $24.1 million and $16.9 million during the three-month periods ended September 30, 2022 and 2021, 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 $53.4 million and $47.1 million during the nine-month periods ended September 30, 2022 and 2021, 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, 2022, the Company expects to recognize the remaining $34.4 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 3.2 years.

A summary of the deferred revenue recognition is as follows (in thousands):


Deferred revenue at December 31, 2020	$	72,842
Milestone payment from Janssen		30,000
Deferred revenue recognized as license revenue during the year ended December 31, 2021		(37,701)
Effects of exchange rate changes		(275)
Deferred revenue at December 31, 2021		64,866
Deferred revenue recognized as license revenue during the nine-month period ended September 30, 2022		(21,208)
Effects of exchange rate changes		(9,294)
Deferred revenue at September 30, 2022	$	34,364

Financing Agreement

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”). Perceptive Advisors, LLC is a 15.6% 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, an affiliate of Perceptive. Refer to the discussion in Note 9 for further information related to the accounting for the Financing Agreement.

Leases

ARE Vivarium Lease

Effective May 1, 2019, the Company entered into an operating lease for vivarium space with ARE-East River Science Park, LLC (“ARE”), which was subsequently amended to add additional space within the vivarium. The initial lease had a term of twelve months which automatically renews on an annual basis.

The rent expense under this operating lease was $0.04 million and $0.03 million for the three-month periods ended September 30, 2022 and 2021, respectively, which are included in loss from operations.

The rent expense under this operating lease was $0.1 million and $0.05 million for the nine-month periods ended September 30, 2022 and 2021, respectively.

The Company made cash payments to ARE in connection with this operating lease in the amount of $0.04 million and $0.01 million during the three-month periods ended September 30, 2022 and 2021, respectively.

The Company made cash payments to ARE in connection with this operating lease in the amount of $0.1 million and $0.05 million during the nine-month period ended September 30, 2022 and 2021, respectively.

There were no amounts due to ARE under this operating lease at September 30, 2022 and December 31, 2021.

Kadmon Lease

The Company leased office space on a month-to-month basis from Kadmon Corporation, LLC (“Kadmon”).

During the three-month periods ended September 30, 2022 and 2021, the Company incurred and paid rent charges from Kadmon in the amount of $0 and $0.2 million, respectively, which are included in loss from operations.

During the nine-month periods ended September 30, 2022 and 2021, the Company incurred and paid rent charges from Kadmon in the amount of $0 and $0.5 million, respectively, which are included in loss from operations.

This lease has been terminated effective November 12, 2021.

Summary of Significant Accounting Policies and Recent Accounting Pronouncements

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies and Recent Accounting Pronouncements

2. Summary of Significant Accounting Policies and Recent Accounting Pronouncements:

Certain of the Company’s significant accounting policies are described below. All of the Company’s significant accounting policies are disclosed in the notes to the audited consolidated financial statements as of and for the year ended December 31, 2021 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

Fair Value Measurements

●

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	2022		(Level 1)		(Level 2)		(Level 3)
Cash and cash equivalents	$	77,907	$	77,907	$	—	$	—
Other long-term liabilities	$	338	$	338	$	—	$	—


	Fair Value Measurement Using:
			Significant		Significant Other		Significant
	December 31,		Observable Inputs		Observable Inputs		Unobservable
Description	2021		(Level 1)		(Level 2)		(Level 3)
Cash and cash equivalents	$	66,585	$	66,585	$	—	$	—
Other long-term liabilities	$	953	$	953	$	—	$	—

Equity Method and Other Investments

Leases

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.

Asset Retirement Obligations

The change in asset retirement obligations is as follows (in thousands):


	For the Nine-Month Period Ended September 30,
	2022		2021
Balance at beginning of period	$	2,081	$	1,814
Additional asset retirement obligations during the period		8		—
Amortization of interest		125		112
Effects of exchange rate changes		(133)		(10)
Balance at end of period	$	2,081	$	1,916

Collaboration Arrangements

Refer to the discussion in Note 7 for further information related to the accounting for the Collaboration Agreement.

Revenue Recognition

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

recognize revenue when (or as) the entity satisfies a performance obligation.

The Company’s collaboration revenue arrangements include the following:

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.

Research and Development

Net Loss per Ordinary Share


	September 30,	September 30,
	2022	2021
Share options	6,968,181	6,141,510
Restricted share units	2,182,500	1,415,000
Restricted ordinary shares subject to forfeiture	28,097	145,000
	9,178,778	7,701,510

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,
	2022		2021
United States	$	21,802	$	23,636
United Kingdom		35,529		43,349
European Union		89,045		69,936
	$	146,376	$	136,921

Recent Accounting Pronouncements Adopted

Recent Accounting Pronouncements Not Yet Adopted

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities:
Net loss	$ (102,302)	$ (69,649)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation expense	21,818	15,359
Foreign currency loss	25,911	4,600
Depreciation and amortization	6,231	5,811
Net change in right-of-use assets and liabilities	(85)	161
Loss on disposal of equipment, furniture and fixtures	(38)
Amortization of interest on asset retirement obligations	125	112
Amortization of debt discount	170
Fair value adjustment	(615)
(Increase) decrease in operating assets:
Accounts receivable - related party	(2,150)	21,484
Prepaid expenses	(2,838)	(1,827)
Tax incentive receivable	6,518	7,518
Other current assets	578	2,387
Other assets	(111)	(519)
Increase (decrease) in operating liabilities:
Accounts payable	8,628	3,898
Accrued expenses	944	(2,012)
Other current liabilities	1,593	(23)
Deferred revenue - related party	(21,208)	(16,658)
Net cash used in operating activities	(56,831)	(29,358)
Cash flows from investing activities:
Purchase of property, plant and equipment	(36,471)	(21,982)
Payment for right-of-use asset		(8,866)
Equity method and other investments		(5,500)
Net cash used in investing activities	(36,471)	(36,348)
Cash flows from financing activities:
Exercise of share options	192	414
Payments of withholdings on shares withheld for income taxes	(2,774)
Payments on lease obligations - financing leases		(1)
Issuance of note payable	75,000
Debt discount in connection with note payable	(2,051)
Net cash (used in) provided by financing activities	70,367	413
Net decrease in cash and cash equivalents	(22,935)	(65,293)
Effect of exchange rate changes on cash	(62)	(593)
Cash and cash equivalents at beginning of the period	137,703	209,520
Cash and cash equivalents at end of the period	114,706	143,634
Supplemental disclosure of non-cash transactions:
Issuance of shares in connection with equity method and other investments		1,165
Fixed asset acquisition included in accounts payable and accrued expenses at end of the period	7,598	4,027
Right-of-use assets obtained in exchange for lease liabilities	1,793	4,424
Asset retirement obligations incurred in connection with leases	8
Warrants issued in connection with note payable	2,273
Supplemental disclosure of cash flow information:
Cash paid for interest	$ 165	$ 57

Share-Based Compensation

9 Months Ended

Sep. 30, 2022

Disclosure of Compensation Related Costs, Share-based Payments [Abstract]

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


					Weighted-
			Weighted-		Average
			Average		Remaining
		Number of	Exercise		Contractual
		Options	Price		Term (years)
Outstanding at December 31, 2021		5,924,690	$	13.16	7.40	years
Granted		1,443,400	$	18.92
Exercised		(18,065)	$	10.61
Forfeited		(381,844)	$	17.90
Outstanding at September 30, 2022		6,968,181	$	14.12	7.08	years
Options exercisable at September 30, 2022		4,388,802	$	12.02	6.15	years
Aggregate intrinsic value of options outstanding as of September 30, 2022	$	3,825
Aggregate intrinsic value of options exercisable as of September 30, 2022	$	3,712

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 $3.8 million and $3.6 million, of which $1.3 million and $1.4 million was recorded as general and administrative expense and $2.5 million and $2.2 million was recorded as research and development expense during the three-month periods ended September 30, 2022 and 2021, respectively.

The total share-based compensation expense recorded in connection with the options was $12.3 million and $11.3 million, of which $4.3 million and $4.6 million was recorded as general and administrative expense and $8.0 million and $6.7 million was recorded as research and development expense during the nine-month periods ended September 30, 2022 and 2021, respectively.

The total fair value of options vested during the three-month periods ended September 30, 2022 and 2021 was $2.6 million and $2.5 million, respectively.

The total fair value of options vested during the nine-month periods ended September 30, 2022 and 2021 was $13.6 million and $12.2 million, respectively.

The weighted-average grant date fair value of options granted during the nine-month periods ended September 30, 2022 and 2021 was $13.07 per share and $11.54 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:


	2022	2021
Risk-free interest rate	1.56 - 3.37%	0.62 - 1.14%
Expected volatility	80%	90%
Expected dividend yield	0%	0%
Expected term (in years)	5.5 - 6.1	5.5 - 6.1

As of September 30, 2022, the total compensation expense relating to unvested options granted that had not yet been recognized was $28.9 million, which is expected to be realized over a period of 3.94 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, 2021 and for the nine-month period ended September 30, 2022 is as follows:


		Weighted-
	Number of	Average
	Restricted	Grant Date
	Share Units	Fair Value
Outstanding at December 31, 2021	1,415,000	$	17.16
Granted	1,180,000	$	20.12
Vested	(397,500)	$	18.40
Forfeited	(15,000)	$	8.25
Outstanding at September 30, 2022	2,182,500	$	18.59

RSUs granted generally vest 50% on the second anniversary of the date of grant and 25% on the third and fourth anniversaries of the date of grant. Annual RSUs granted to directors generally vest in a single installment on the earliest to occur of the first anniversary of the grant date or the day immediately prior to the date of the next annual meeting of the Company’s shareholders occurring after the date of grant. The RSUs granted to the directors in June 2021 will be paid on or within 30 days after the date a director ceases to serve on the board. For RSUs granted in June 2022 and future years, the directors may annually elect whether to defer the payment of their annual RSU awards under the Deferred Compensation Plan for Non-Employee Directors. The related share-based compensation expense, which is recognized ratably over the requisite service period, is included in general and administrative and research and development expenses, as applicable, in the condensed consolidated statements of operations and comprehensive loss.

Total share-based compensation expense recorded in connection with the RSUs was $3.2 million and $1.7 million, of which $2.2 million and $1.5 million was recorded as general and administrative expense and $1.0 million and $0.2 million was recorded as research and development expense during the three-month periods ended September 30, 2022 and 2021, respectively.

Total share-based compensation expense recorded in connection with the RSUs was $9.5 million and $4.1 million, of which $6.7 million and $3.5 million was recorded as general and administrative expense and $2.8 million and $0.6 million was recorded as research and development expense during the nine-month periods ended September 30, 2022 and 2021, respectively.

As of September 30, 2022, the total compensation expense relating to unvested RSUs granted that had not yet been recognized was $29.9 million, which is expected to be realized over a period of 3.3 years.

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, 2022, the Company withheld 128,812 ordinary shares with a total value of approximately $2.8 million. No shares were withheld during the nine months ended September 30, 2021. These amounts are presented as a cash outflow from financing activities in the accompanying consolidated statement of cash flows.


	Three-Month Period Ended September 30,
	2022		2021
Research and development	$	3,482	$	2,436
General and administrative		3,455		2,903
Total share-based compensation	$	6,937	$	5,339


	Nine-Month Period Ended September 30,
	2022		2021
Research and development	$	10,780	$	7,273
General and administrative		11,038		8,086
Total share-based compensation	$	21,818	$	15,359

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, 2022 and 2021.

Subsequent Event

9 Months Ended

Sep. 30, 2022

Subsequent Event

Subsequent Event

11. Subsequent Event

On November 9, 2022, the Company entered into a securities purchase agreement with JJDC pursuant to which the Company, in a private placement, agreed to issue and sell to JJDC an aggregate of 3,742,514 ordinary shares at a purchase price of $6.68 per share, for gross proceeds of approximately $25.0 million (the “Private Placement”).

In connection with the Private Placement, the Company intends to enter into a registration rights agreement whereby the Company will be obligated to prepare and file with the Securities and Exchange Commission a registration statement to register for resale the shares within 180 days of executing the registration rights agreement. The Company shall use reasonable best efforts to have the registration statement declared effective as soon as practicable.

Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Clinical trial costs	$ 17,627	$ 12,524
Manufacturing costs	1,471	2,889
Fixed assets	1,304	2,077
Compensation and benefits	1,516	6,029
Consulting	1,156	1,018
Research and development	1,120	858
Professional fees	180	1,735
Other	400	456
Accrued expenses	$ 24,774	$ 27,586

CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY - USD ($)	Ordinary Shares [Member]	Capital in Excess of Par Value [Member]	Accumulated Other Comprehensive (Loss) Income [Member]	Accumulated Deficit [Member]	Total
Share based compensation activity		$ 4,958,000			$ 4,958,000
Share based compensation activity, shares	17,923
Issuance of shares in connection with equity method and other investments		1,165,000			1,165,000
Issuance of shares in connection with equity method and other investments, shares	75,000
Other comprehensive income			$ (271,000)		(271,000)
Net loss				$ (23,618,000)	(23,618,000)
Balance at Mar. 31, 2021	$ 2,000	510,605,000	(5,168,000)	(284,646,000)	220,793,000
Beginning Balance at Dec. 31, 2020	$ 2,000	504,482,000	(4,897,000)	(261,028,000)	238,559,000
Balance, Shares at Mar. 31, 2021	44,282,073
Beginning Balance, Shares at Dec. 31, 2020	44,189,150
Other comprehensive income					1,991,000
Net loss					(69,649,000)
Balance at Sep. 30, 2021	$ 2,000	521,420,000	(2,906,000)	(330,677,000)	187,839,000
Beginning Balance at Dec. 31, 2020	$ 2,000	504,482,000	(4,897,000)	(261,028,000)	238,559,000
Balance, Shares at Sep. 30, 2021	44,316,385
Beginning Balance, Shares at Dec. 31, 2020	44,189,150
Share based compensation activity		5,422,000			5,422,000
Share based compensation activity, shares	27,380
Other comprehensive income			(407,000)		(407,000)
Net loss				(20,086,000)	(20,086,000)
Balance at Jun. 30, 2021	$ 2,000	516,027,000	(5,575,000)	(304,732,000)	205,722,000
Beginning Balance at Mar. 31, 2021	$ 2,000	510,605,000	(5,168,000)	(284,646,000)	220,793,000
Balance, Shares at Jun. 30, 2021	44,309,453
Beginning Balance, Shares at Mar. 31, 2021	44,282,073
Share based compensation activity		5,393,000			5,393,000
Share based compensation activity, shares	6,932
Other comprehensive income			2,669,000		2,669,000
Net loss				(25,945,000)	(25,945,000)
Balance at Sep. 30, 2021	$ 2,000	521,420,000	(2,906,000)	(330,677,000)	187,839,000
Beginning Balance at Jun. 30, 2021	$ 2,000	516,027,000	(5,575,000)	(304,732,000)	205,722,000
Balance, Shares at Sep. 30, 2021	44,316,385
Beginning Balance, Shares at Jun. 30, 2021	44,309,453
Share based compensation activity		4,996,000			4,996,000
Share based compensation activity, shares	161,753
Other comprehensive income			1,933,000		1,933,000
Net loss				(31,045,000)	(31,045,000)
Balance at Mar. 31, 2022	$ 2,000	533,655,000	(738,000)	(371,634,000)	161,285,000
Beginning Balance at Dec. 31, 2021	$ 2,000	528,659,000	(2,671,000)	(340,589,000)	$ 185,401,000
Balance, Shares at Mar. 31, 2022	44,710,678
Beginning Balance, Shares at Dec. 31, 2021	44,548,925
Exercise of share options, shares					18,065
Other comprehensive income					$ 18,062,000
Net loss					(102,302,000)
Taxes withheld on issuance of share-based awards					2,774,000
Balance at Sep. 30, 2022	$ 2,000	550,168,000	15,391,000	(442,891,000)	122,670,000
Beginning Balance at Dec. 31, 2021	$ 2,000	528,659,000	(2,671,000)	(340,589,000)	185,401,000
Balance, Shares at Sep. 30, 2022	44,725,678
Beginning Balance, Shares at Dec. 31, 2021	44,548,925
Share based compensation activity		7,303,000			7,303,000
Other comprehensive income			7,357,000		7,357,000
Net loss				(33,973,000)	(33,973,000)
Balance at Jun. 30, 2022	$ 2,000	540,958,000	6,619,000	(405,607,000)	141,972,000
Beginning Balance at Mar. 31, 2022	$ 2,000	533,655,000	(738,000)	(371,634,000)	161,285,000
Balance, Shares at Jun. 30, 2022	44,710,678
Beginning Balance, Shares at Mar. 31, 2022	44,710,678
Share based compensation activity	$ 15,000	6,937,000			6,937,000
Other comprehensive income			8,772,000		8,772,000
Warrants issued in connection with note payable		2,273,000			2,273,000
Net loss				(37,284,000)	(37,284,000)
Balance at Sep. 30, 2022	2,000	550,168,000	15,391,000	(442,891,000)	122,670,000
Beginning Balance at Jun. 30, 2022	$ 2,000	$ 540,958,000	$ 6,619,000	$ (405,607,000)	$ 141,972,000
Balance, Shares at Sep. 30, 2022	44,725,678
Beginning Balance, Shares at Jun. 30, 2022	44,710,678

Share-Based Compensation - Schedule of Grant Date Fair Values of the Share Options Granted Black-Scholes Valuation Model (Details) - Share Options	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate, minimum	1.56%	0.62%
Risk-free interest rate, maximum	3.37%	1.14%
Expected volatility	80.00%	90.00%
Expected dividend yield	0.00%	0.00%
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected life (in years)	5 years 6 months	5 years 6 months
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected life (in years)	6 years 1 month 6 days	6 years 1 month 6 days