MeiraGTx Holdings plc
For the period ended Dec 31, 2025. Filed Mar 30, 2026.
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FY2025 · Filed Mar 30, 2026
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Notes to Consolidated Financial Statements
- Principal Business Activity
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 genetic medicines company with a broad pipeline of late-stage clinical programs, including radiation-induced xerostomia, Parkinson's disease and AIPL1-associated retinal dystrophy. MeiraGTx clinical programs use targeted local delivery of small doses of genetic medicines to treat both inherited and more common conditions with severe unmet need. The successful development of the clinical pipeline is supported by the Company’s internal end-to-end manufacturing capabilities. The Company has two viral vector production facilities for good manufacturing practices (“GMP”), internal plasmid production for GMP, as well as an in-house Quality Control hub for stability and release, all fit for IND through commercial supply. In addition, the Company has developed a proprietary manufacturing platform with industry-leading yield and quality aspects and commercial readiness. The Company’s core capabilities in viral vector and capsid optimization allow increased potency, decreased dose and significantly reduced cost of goods for its genetic medicines. The Company has developed a transformative gene regulation platform using bespoke synthetic riboswitch technology invented in-house that allows for the precise, dose-responsive expression of any transgene under the control of oral small molecules. The Company is focusing the riboswitch platform onin vivodelivery of biologic therapeutics such as the metabolic peptides GLP-1, GIP, glucagon, amylin, PYY and leptin via oral small molecules, as well as cell therapy for oncology and autoimmune diseases, and long-term intractable pain. The Company has developed unique comprehensive technology capabilities to apply genetic medicine to more prevalent diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high.
Hologen Transactions
On March 9, 2025 (the “Signing Date”), the Company and its affiliates entered into a strategic collaboration with Hologen Limited, a non-cellular company limited by shares incorporated in Guernsey (“Hologen”), and its affiliates. Hologen is a leading developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development. As part of the strategic collaboration, the Company and Hologen have entered into the Framework Agreements (as defined below), pursuant to which the Company and its affiliates will receive from Hologen an upfront cash payment of$200.0 million (the “Upfront Payment”) on the Closing Date (as defined below), and Hologen will provide additional funding of up to an additional $230.0 million as further described below. As part of the strategic collaboration, the Company also received an aggregate of 500,000 Class A shares of Hologen at a nominal price. During the year ended December 31, 2025, Hologen made $50.0 million in payments as part of its commitment toward the Upfront Payment which is included in other current liabilities, and made an additional $55.0 million payment to date during the first quarter 2026.
The closing of the transactions contemplated by the Framework Agreements (the “Closing Date”) is expected to occur in the second calendar quarter of 2026, subject to customary closing and funding conditions.
Neuro Framework Agreement
On the Signing Date, the Company, MeiraGTx Neuro UK Limited, a private company limited by shares incorporated in England and a wholly-owned subsidiary of the Company (“MeiraGTx Neuro UK”), Hologen Neuro AI Limited, a non-cellular company limited by shares incorporated in Guernsey and an affiliate of Hologen (“Hologen Neuro”), and Hologen, entered into that certain Framework Agreement (the “Neuro Framework Agreement”), pursuant to which, on the Closing Date, the Company, MeiraGTx Neuro UK, MeiraGTx Neuro I, LLC, a Delaware limited liability company and a wholly-owned subsidiary of the Company (“MeiraGTx Neuro US”), Hologen, Hologen Neuro and Hologen Neuro AI UK Limited, a private company limited by shares incorporated in England and an affiliate of Hologen (“Hologen Neuro UK”), shall enter into a Collaboration and
License Agreement (the “Hologen Collaboration Agreement”) for the research, development, manufacture and commercialization of the Company’s (i) AAV-GAD investigational gene therapy for the treatment of Parkinson’s disease, AAV-BDNF investigational gene therapy for the treatment of genetic obesity disorders and other potential locally delivered genetic medicines to the central nervous system (the “Clinical Programs”) and (ii) proprietary device designed to effect the local delivery of a gene therapy product into the central nervous system or any topographic or subcutaneous tissue modification on the face and scalp, of humans or animals (the “Delivery Device”), in each case, in accordance with the terms and conditions of the Hologen Collaboration Agreement.
On the Closing Date, under the Hologen Collaboration Agreement, MeiraGTx Neuro US will receive the applicable portion of the Upfront Payment in consideration for granting to Hologen Neuro and Hologen Neuro UK, as of the Closing Date and subject to the license granted by Hologen Neuro and Hologen Neuro UK back to MeiraGTx Neuro UK, exclusive, worldwide, royalty-free, fully paid-up licenses to certain of the Company’s intellectual property rights for the research, development, manufacture and commercialization of the Clinical Programs and the Delivery Device. On the Closing Date, (a) MeiraGTx Neuro UK will receive Class A shares of Hologen Neuro representing a 30% ownership of the issued share capital of Hologen Neuro, in consideration for the provision of services to Hologen Neuro and Hologen Neuro UK as specified in the Hologen Collaboration Agreement, including services relating to the development of the Clinical Programs and the Delivery Device and certain other transition services, and (b) Hologen Guernsey will receive Class B shares of Hologen Neuro representing a 70% ownership of the issued share capital of Hologen Neuro, in consideration for paying the applicable portion of the Upfront Payment to MeiraGTx Neuro US, as well as a commitment to provide additional capital of up to $230.0 million to fund the development of the Clinical Programs and the Delivery Device. Additionally, Hologen will license to Hologen Neuro its proprietary multi-modal generative foundation models (LMMs), or large medicine models, pursuant to a license agreement mutually agreeable to the parties.
As of the Closing Date, Hologen Neuro shall be governed by a board of directors comprised of three representatives designated by Hologen and two representatives designated by MeiraGTx Neuro UK, and certain material business decisions (as further enumerated in the Neuro Framework Agreement) will require the approval of at least 70% of the directors then in office.
Following the Closing Date and in accordance with the terms of the Hologen Collaboration Agreement, the parties shall negotiate in good faith and enter into clinical and commercial supply agreements, pursuant to which MeiraGTx Neuro UK (directly, or through affiliates or subcontractors) shall manufacture and supply AAV-GAD, AAV-BDNF and other potential locally delivered genetic medicines to the central nervous system.
Manufacturing Framework Agreement
On the Signing Date, MeiraGTx Manufacturing Limited, a private company limited by shares incorporated in England and a wholly-owned subsidiary of the Company (“MeiraGTx Manufacturing”), MeiraGTx Limited, a private company limited by shares incorporated in England and a wholly-owned subsidiary of the Company (“MeiraGTx Limited”), and Hologen, entered into that certain Framework Agreement (the “Manufacturing Framework Agreement” and, together with the Neuro Framework Agreement, the “Framework Agreements”), pursuant to which, on the Closing Date and in exchange for the applicable portion of the Upfront Payment, Hologen will acquire a minority interest in MeiraGTx Manufacturing, an entity that will comprise the Company’s flexible and scalable end-to-end genetic medicines manufacturing business, which is solely run by MeiraGTx Manufacturing and MeiraGTx Limited prior to the Closing Date. Hologen will also contribute a portion of the annual funding to MeiraGTx Manufacturing.
As of the Closing Date, MeiraGTx Manufacturing shall be governed by a board of directors comprised of three representatives designated by MeiraGTx Limited and two representatives designated by Hologen, and certain material business decisions (as further enumerated in the Manufacturing Framework Agreement) will require the approval of at least 70% of the directors then in office.
For a period of twelve months following the Closing Date, Hologen has an exclusive, irrevocable option to purchase additional shares in MeiraGTx Manufacturing at a specified price, such that following exercise of such option, Hologen shall own 40% of the issued share capital of MeiraGTx Manufacturing in the aggregate. In the event that Hologen does not exercise its option, MeiraGTx has an exclusive, irrevocable option to purchase all of the shares of MeiraGTx Manufacturing held by Hologen for the same price that Hologen paid for such shares. Such option shall be exercisable anytime beginning on the third anniversary of the Closing Date and ending three years thereafter.
Eli Lilly and Company Collaboration Agreement
On November 7, 2025 (the “Effective Date”), Meira Ocular, MeiraGTx Limited and Meira UK II (collectively, “Meira”), entered into a strategic collaboration and license agreement with Eli Lilly and Company (“Lilly”) (the “Lilly Collaboration Agreement”) for the research, development and commercialization of genetic medicines in and related to the area of ophthalmology. Under the Lilly Collaboration Agreement, Meira has granted Lilly exclusive, worldwide rights to research, develop and commercialize the Company’s product candidate AAV-AIPL1, which treats Leber congenital amaurosis 4, or LCA4, caused by mutations in the AIPL1 gene, as well as two other preclinical product candidates which are intended to treat other inherited retinal dystrophies. As of the Effective Date, Lilly has (i) an exclusive license to proprietary intravitreal capsids for use with up to five targets, relating to or useful in the field of ophthalmology, to be selected by Lilly, (ii) an exclusive license to proprietary pan-retinal or rod-specific promoters for use with up to five targets, relating to or useful in the field of ophthalmology, to be selected by Lilly and (iii) a right of first designation with respect to certain target-specific transactions that MeiraGTx Ocular or its affiliates may seek to pursue in the field of ophthalmology. Lilly also has a right of first negotiation for use of the Company’s proprietary riboswitch technology in the field of ophthalmological gene editing.
Under the terms of the Lilly Collaboration Agreement, Meira received an upfront payment of $75.0 million after signing the Lilly Collaboration Agreement and will be eligible to receive up to over $400.0 million in total milestone payments, including up to $135.0 million in other potential near-term cash consideration upon the achievement of certain development and regulatory approval milestones. Lilly has the right to research, develop and commercialize products under the Lilly Collaboration Agreement, at its cost. To the extent certain activities are performed by the Company in connection with the collaboration, the Company may receive reimbursement for such activities in accordance with the terms of the Lilly Collaboration Agreement. The Lilly Collaboration Agreement also provides for tiered royalties to be paid to MeiraGTx Ocular.
Asset Purchase and Related Agreements with Johnson & Johnson Innovative Medicine
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 $30.0 million milestone payment in December 2021. The Company also received funding for certain research, manufacturing, clinical development and commercialization costs, and had the potential to obtain additional milestone payments upon the achievement of such milestones and royalties on future net sales of products. On December 20, 2023, the Company entered into an Asset Purchase Agreement (“Asset Purchase Agreement”) with Janssen pursuant to which the Company sold and assigned to Janssen, and Janssen purchased and assumed, that certain License Agreement, dated February 5, 2019, by and between UCL Business Plc (now UCL Business Ltd.) (“UCLB”), on the one hand, and MeiraGTx UK II Limited and MeiraGTx Limited, on the other hand (the “UCLB RPGR License Agreement”), relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets as described in the Asset Purchase Agreement. In connection with entering into the Asset Purchase Agreement, the Company entered into a Termination Agreement with Janssen terminating the Collaboration Agreement. The Company and Janssen also entered into a Supply Agreement on December 20, 2023 pursuant to which the Company agreed to manufacture and supply the RPGR Product for Janssen.
Under the Asset Purchase Agreement, Janssen paid the Company a non-refundable upfront cash payment of $65.0 million in December 2023. Additionally, pursuant to and subject to the terms and conditions set forth in the Asset Purchase Agreement, Janssen agreed to pay the Company future contingent consideration of up to an aggregate of $350.0 million, as follows: (i) a milestone payment of $50.0 million in connection with the achievement of the initiation of the extension study for the Phase 3 LUMEOS clinical trial for the RPGR Product; (ii) $10.0 million upon completion of certain specified development services for the drug substance for the RPGR Product; (iii) $5.0 million upon completion of certain specified development services for the drug product for the RPGR Product; (iv) $175.0 million upon the first commercial sale of an RPGR Product in the United States; (v) $75.0 million upon the first commercial sale of an RPGR Product in at least one of the United Kingdom, France, Germany, Spain and Italy; (vi) $25.0 million upon completion of the transfer of certain manufacturing technology for drug substance and drug product from the Company to Janssen; and (vii) $10.0 million upon regulatory approval of a Janssen-selected manufacturing facility in each of the United States and European Union for commercial manufacture of the RPGR Product. During 2024, the Company received $60.0 million in milestone payments from Johnson & Johnson Innovative Medicine. Janssen is also responsible for any royalty or milestone amounts that become payable on the RPGR Product under the UCLB RPGR License Agreement.
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Liquidity
The Company has not yet achieved profitable operations. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of the Company’s product candidates will require significant additional financing. The Company’s accumulated deficit at December 31, 2025 totaled $816.2 million, and management expects to incur substantial losses in future periods. The success of the Company is subject to certain risks and uncertainties, including among others, uncertainty of product development; competition in the Company’s field of use; uncertainty of capital availability; uncertainty in the Company’s ability to enter into agreements with collaborative partners; expanding and protecting the Company’s intellectual property portfolio; dependence on third parties; and dependence on key personnel. For the year ended December 31, 2025, the Company used $46.4 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 December 31, 2025, the Company had cash, cash equivalents and restricted cash in the amount of $68.2 million, which consisted of depository and money market accounts held at large international banks. The Company estimates that its cash and cash equivalents on hand, accounts receivable – related party and tax incentive receivable at December 31, 2025, together with the $55.0 million received to date in the first quarter of 2026, which is non-refundable, and $5.0 million in receivables from Hologen, will be sufficient to cover its expenses for at least the next twelve months from the date of issuance of these consolidated financial statements.
Risks and Uncertainties
The Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risks, including the potential risk of business failure.
The Company’s capital resources and operations to date have been funded primarily with the proceeds from the Company’s collaboration and business development activities and private and public equity offerings, as well as the proceeds from the debt financing described in Note 14. In the future, the Company may seek to raise additional capital through equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources to enable it to complete the development and potential commercialization of its product candidates.
- Summary of Significant Accounting Policies
Consolidation
The accompanying 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;
MeiraGTx Belgium, a private company with limited liability incorporated under the laws of Belgium (“Meira Belgium”);
MeiraGTx Cell Therapies, a simplified joint stock company, incorporated under the laws of France;
BRI-Alzan, Inc., a Delaware corporation;
MeiraGTx Bio Inc., a Delaware corporation;
MeiraGTx B.V., a private company with limited liability incorporated under the laws of the Netherlands;
MeiraGTx Neurosciences, Inc., a Delaware corporation;
MeiraGTx Therapeutics, Inc., a Delaware corporation;
MeiraGTx UK Limited, a limited company incorporated under the laws of England and Wales (“Meira UK”);
MeiraGTx Neuro I, LLC, a Delaware limited liability company;
MeiraGTx Neuro II, LLC, a Delaware limited liability company;
MeiraGTx Manufacturing Limited, a limited company incorporated under the laws of England and Wales;
MeiraGTx Ocular UK Limited, a limited company incorporated under the laws of England and Wales;
MeiraGTx Gene Regulation Limited, a limited company incorporated under the laws of England and Wales; and
MeiraGTx Neuro UK Limited, a limited company incorporated under the laws of England and Wales.
All intercompany balances and transactions between the consolidated companies have been eliminated in consolidation.
Use of Estimates
Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in
actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these consolidated financial statements, management used significant estimates in the following areas, among others: collaboration and service revenue, fair value of nonfinancial assets, stand-alone selling price and material rights in connection with the Asset Purchase and Supply Agreements, the accounting for research and development costs, share-based compensation, leases, asset retirement obligations, fair value of financial instruments and tax incentive receivable.
Cash and Cash Equivalents
The Company considers all highly liquid instruments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of checking and money market accounts held at large international banks that are readily convertible into cash.
Restricted Cash
Restricted cash represents a guarantee put in place as required by the terms of the research and innovation grant from IDA Ireland which offers financial assistance in establishing the Company’s operations in Shannon, Ireland. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash reported in the Company’s consolidated balance sheets to the total of the amount presented in the consolidated statements of cash flows (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | December 31, | | December 31, |
| | | 2025 | | 2024 |
| Cash and cash equivalents | | $65,931 | | $103,659 |
| Restricted cash | | 2,262 | | 2,009 |
| Total cash, cash equivalents and restricted cash in the consolidated statement of cash flows | | $68,193 | | $105,668 |
Inventory
The Company’s inventory consists entirely of raw materials and is valued at the lower of cost or net realizable value. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis. During the year ended December 31, 2025, the Company recognized a provision loss for obsolete and excess inventory of$0.4 million.
Financial Instruments
The carrying value of accounts receivable – related party, tax incentive receivable, other current assets, and accounts payable reported in the consolidated balance sheets equal or approximate fair value due to their short maturities.
Tax Incentive Receivable
Meira UK II and Meira UK are eligible to participate in United Kingdom (“UK”) research and development tax incentive programs under which it is eligible to receive a cash refund from His Majesty’s Revenue & Customs (“HMRC”) for a percentage of the qualified research and development costs expended by both entities under the merged research and development expenditures credit (“RDEC”) program. The Company’s estimate of the amount of cash refund it expects to receive related to the RDEC program is included in tax incentive receivable in the accompanying consolidated balance sheets and such amounts are recorded as a reduction of research and development expense in the consolidated statements of operations. During the years ended December 31, 2025 and
2024, the Company recorded reductions to research and development expenses of $10.9 million and $5.5 million, respectively. Amounts included in 2025 include incremental cash to be received from 2024 RDEC and small and medium sized enterprises schemes which are not applicable for 2025 and beyond.
In addition, the Company incurs Value Added Tax (“VAT”) on services provided by UK and European Union vendors, which it is entitled to reclaim. The Company’s estimate of the amount of cash refund it expects to receive related to VAT was $0.9 million and $2.0 million as of December 31, 2025 and 2024, respectively, which is included in other current assets in the accompanying consolidated balance sheets.
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 own credit risk.
The Company follows ASC 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 | ||||||||
| | | December 31, | | Observable Inputs | | Observable Inputs | | Unobservable |
| Description | | 2025 | | (Level 1) | | (Level 2) | | (Level 3) |
| Cash equivalents | | $60,253 | | $60,253 | | $— | | $— |
| Restricted cash | | $2,262 | | $2,262 | | $— | | $— |
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Fair Value Measurement Using: | ||||||||
| · · · · · Significant · · Significant Other · · Significant | ||||||||
| | | December 31, | | Observable Inputs | | Observable Inputs | | Unobservable |
| Description | | 2024 | | (Level 1) | | (Level 2) | | (Level 3) |
| Cash equivalents | | $80,930 | | $80,930 | | $— | | $— |
| Restricted cash | | $2,009 | | $2,009 | | $— | | $— |
At December 31, 2025, the Company believes the carrying value of the Tranche 1 Notes (as defined in Note 14) 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 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.
Concentrations of Credit Risk
The Company maintains its cash and cash equivalents primarily in depository and money market accounts within two large financial institutions in the United States and one large financial institution in the United Kingdom and Ireland. Cash balances deposited at these major financial banking institutions exceed the insured limits. The Company has not experienced any losses on its bank deposits and believes these deposits do not expose the Company to any significant credit risk.
Intangible Assets
Intangible assets consist of purchased rights to licensed technology as it relates to the Company’s manufacturing processes and has future alternative use in the Company’s operations. The licensed technology is being amortized on a straight-line basis over 7 years, which represents the estimated period of benefit and the expected pattern of consumption (see Note 6).
Property, Plant and Equipment, Net
Property, plant and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are depreciated over the lesser of their useful lives or the terms of the leases (see Note 5).
The estimated useful lives of the asset categories are as follows:
| | | |
|---|---|---|
| Asset Category | | Useful Lives |
| Computer and office equipment | 3 years | |
| Laboratory equipment | 5 years | |
| Furniture and fixtures | 5 years | |
| Manufacturing equipment | 7 years | |
| Leasehold improvements | lesser of useful life or remaining term of lease |
Expenditures for leasehold improvements are capitalized, and expenditures for maintenance and repairs are expensed to operations as incurred.
ASC 360,Property, Plant and Equipment, addresses the financial accounting and reporting for impairment or disposal of long-lived assets. The Company reviews the recorded values of long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset or group of assets may not be fully recoverable. The Company did not record any material impairment charges in 2025 or 2024.
Leases
The Company accounts for leases in accordance with ASC 842,Leases (“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 – operating leases, net and lease obligations on the Company’s 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 – finance leases, net and lease obligations on the Company’s 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 lease terms 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 on the Company’s consolidated balance sheets were measured during a period of historically low interest rates. The impact on measurements of new asset retirement obligations using different rates in the future may be significant.
The Company uses estimates to determine the asset retirement obligations at the end of the lease term and discounts such asset retirement obligations using an estimated discount rate. Interest on the discounted asset retirement obligation is amortized over the term of the lease using the effective interest method and is recorded as interest expense in the consolidated statements of operations and comprehensive loss.
During the year ended December 31, 2025, the Company elected to exercise its early termination option on an operating lease for laboratory and office space. At that time, the Company had recorded an asset retirement obligation liability in the amount of $1.7 million and a corresponding leasehold improvement with a net book value of $0.3 million. The landlord also indicated that the Company would not be required to restore the premises. As a result, the Company released $1.7 million asset retirement obligation liability. In connection with the lease termination, the Company has also wrote off the remaining leasehold improvements. The lease was terminated effective August 31, 2025. The combined impact of releasing the asset retirement obligation liability and writing off the leasehold improvements resulted in a net gain of approximately $1.4 million, which is included in general and administrative expenses in the consolidated statements of operations for the year ended December 31, 2025.
The change in asset retirement obligations is as follows (in thousands):
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|---|---|---|---|---|---|---|
| · · For the Years Ended December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Balance at beginning of period | | $2,821 | | $2,401 | ||
| Change in estimate | | | (1,676) | | | 345 |
| Assignment of leases to Johnson & Johnson Innovative Medicine | | | — | | | (115) |
| Amortization of interest | | 153 | | 209 | ||
| Effects of exchange rate changes | | 101 | | (19) | ||
| Balance at end of period | | $1,399 | | $2,821 | ||
IDA Ireland Grant
In August 2021, Meira Ireland entered into an agreement pursuant to which it received a grant from IDA Ireland for financial assistance in establishing its operations in Shannon, Ireland. Under the terms of the grant, Meira Ireland is eligible to receive the lesser of €1.0 million or €10,000 for each job created (the “employment grant”) and the lesser of €1.2 million or 4% of the actual expenditure on the provision of machinery and equipment (the “capital grant”). Meira Ireland may apply for a drawdown of the employment grant once a job has been created and the position has been held for a period of at least one month, and may apply for a drawdown of the capital grant once an eligible asset has been purchased and installed, conditioned on the creation of a cumulative number of jobs by the end of the immediately preceding year. An aggregate of 100 jobs must be created to receive the maximum benefit under the capital grant. An application for a drawdown must be accompanied by an audit certification for compliance with the terms of the grant. The Company has a guarantee in place with a bank in favor of IDA Ireland, pursuant to which it restricts cash in the amount of claims made under the grant such that the Company maintains the funds to cover any portion of the grant income that may become repayable in the future. This amount is presented as restricted cash in the accompanying consolidated balance sheet. All expenditures were required to be completed by December 31, 2024, and the agreement terminates on the later offive years from the date of the last payment from the grant orfive years from completion of the capital investment, which is expenditure of at least €30.0 million on eligible machinery and equipment.
The Company recognizes grant income when there is reasonable assurance that the Company will comply with the conditions attached to the grant and that it will receive the grant. Grant income from the employment grant is recognized as a deduction from the amount of the related expense, and grant income from the capital grant is deducted from the carrying amount of the related asset and recognized in income over the asset’s useful life in the form of a reduced depreciation charge. The Company received its first drawdown under the grant in 2023, which was comprised of $0.6 million for the employment grant and $0.4 million for the capital grant. The Company received its second drawdown under the grant in 2024, which was comprised of $0.5 million for the employment grant and $0.5 million for the capital grant. The Company received its third and final drawdown under the grant in 2025, which was comprised of a de minimis amount for the employment grant and $0.1 million for the capital grant. During the years ended December 31, 2025 and 2024, respectively, the Company recognized $0.1 million and $0.6 million of grant income as a reduction of research and development expenses in the accompanying consolidated statements of operations and comprehensive loss.
Until the termination of the grant agreement in September 2030, Meira Ireland must maintain compliance with the terms of the grant. If the total number of jobs is less than 100 at the time of IDA Ireland’s annual review, the Company may have to repay a portion of the capital grant, and if a job for which the Company received employment grant funding remains vacant for a period in excess ofsix calendar months, the Company may have to repay the employment grant received for that job.
Share-Based Compensation Expense
Options
The Company grants share options to employees, non-employee members of the Company’s board of directors and non-employee consultants as compensation for services performed. Employee and non-employee members of the board of directors’ awards of share-based compensation are accounted for in accordance with ASC 718,Compensation –Stock Compensation, or ASC 718*.* The Company accounts for forfeitures of stock option awards as they occur. ASC 718 requires all share-based payments to employees and non-employee directors, including grants of share options, to be recognized in the consolidated statement of operations and comprehensive loss based on their grant date fair values. The grant date fair value of share options is estimated using the Black-Scholes option valuation model.
Using this model, fair value is calculated based on assumptions with respect to (i) the fair value of the Company’s ordinary shares on the grant date; (ii) expected volatility of the Company’s ordinary share price, (iii) the periods of time over which the optionees are expected to hold their options prior to exercise (expected term), (iv) expected dividend yield on the Company’s ordinary shares, and (v) risk-free interest rates.
The assumptions underlying these valuations represented management’s best estimate, which involved inherent uncertainties and the application of management’s judgment. As a result, if the Company had used different assumptions or estimates, the fair value of its ordinary shares and its share-based compensation expense could have been materially different.
The expected term of share options granted to the optionees is determined using the average of the vesting period and contractual life of the option.
Expected volatility is based on an analysis of guideline companies and the Company’s own volatility in accordance with ASC 718. The expected dividend yield is zero as the Company has never paid dividends and does not currently anticipate paying any in the foreseeable future. Risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the option’s expected term.
Restricted Share Units
The Company grants restricted share units (“RSUs”) to employees, non-employee members of the Company’s board of directors and non-employee consultants as compensation for services performed. Awards of RSUs are accounted for in accordance with ASC 718*.* ASC 718 requires all share-based payments to employees, non-employee members of the Company’s board of directors and non-employee consultants, including grants of RSUs, to be recognized in the consolidated statement of operations and comprehensive loss based on their grant date fair values. The grant date fair value of RSUs is determined using the closing market price of the Company’s ordinary shares on the date of grant.
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.
ASC 808 does not address recognition or measurement matters related to collaborative arrangements. Units of account pursuant to a collaborative arrangement that are within the scope of other authoritative accounting literature are accounted for using the relevant provisions of that literature. If the Company concludes that some or all aspects of the arrangement are within the scope of ASC 808 and do not represent a transaction with a customer, the Company recognizes its allocation of the shared costs incurred with respect to the jointly conducted activities pursuant to ASC 730,Research and Development (“ASC 730”). If the Company concludes that some or all aspects of the arrangement represent a transaction with a customer, the Company accounts for those aspects of the arrangement within the scope of ASC 606. If the payments are not within the scope of other authoritative accounting literature, the recognition and measurement for the consideration in the arrangement 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. Consideration 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 12 for further information related to the accounting for the Collaboration Agreement with Johnson & Johnson Innovative Medicine.
Revenue Recognition
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 promises in 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.
At inception, the Company determines whether contracts are within the scope of ASC 606 or other topics. For contracts that are determined to be within the scope of 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 the Company performs the following five steps:
| i. | identify the contract(s) with a customer; |
|---|
| ii. | identify the performance obligations in the contract; |
|---|
| iii. | determine the transaction price; |
|---|
| iv. | allocate the transaction price to the performance obligations within the contract; and |
|---|
| v. | recognize revenue when (or as) the entity satisfies a performance obligation. |
|---|
The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.
At contract inception, 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.
If there are multiple performance obligations, the Company allocates the transaction price to each performance obligation based on their estimated standalone selling prices (“SSP”). The Company estimates the SSP for each performance obligation by considering information such as market conditions, entity-specific factors, and information about its customer that is reasonably available. The Company considers estimation approaches that allow it to maximize the use of observable inputs. These estimation approaches may include the adjusted market assessment approach, the expected cost plus a margin approach or the residual approach. The Company also considers whether to use a different estimation approach or a combination of approaches to estimate the SSP for each performance obligation. Developing certain assumptions (e.g., treatable patient population, expected market share, probability of success and product profitability, and discount rate based on weighted-average cost of capital) to estimate the SSP of a performance obligation requires significant judgment.
The Company records amounts as contract assets when the right to consideration is deemed unconditional. Contract assets are reclassified as accounts receivable once billed. 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 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 and 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 non-refundable, 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: Under the Collaboration Agreement, the Company incurred research and development costs, with Johnson & Johnson Innovative Medicine responsible for up to 100% of the costs, depending on the type of research and development services being performed. The Company recorded costs associated with the development activities as research and development expenses in the consolidated statements of operations and comprehensive loss consistent with ASC 730. The reimbursement of the research and development costs by Johnson & Johnson Innovative Medicine was representative of the joint risk sharing nature of the arrangement. The Company considered the guidance in ASC 808 and recognizes the payments received from Johnson & Johnson Innovative Medicine as a reduction to research and development expense when the related costs are incurred. Under the Asset Purchase Agreement, research and development services (PPQ services) are recorded as incurred under cost of service revenue – related party.
Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations at the outset of the arrangement.
Customer Options: Customer options are evaluated at contract inception to determine whether those options provide a material right (i.e., an optional good or service offered for free or at a discount) to the customer. If the customer options represent a material right, the material right is treated as a separate performance obligation at the outset of the arrangement. The Company allocates the transaction price to material rights based on the standalone selling price. As a practical alternative to estimating the standalone selling price of a material right when the underlying
goods or services are both (i) similar to the original goods or services in the contract and (ii) provided in accordance with the terms of the original contract, the Company allocates the total amount of consideration expected to be received from the customer to the total goods or services expected to be provided to the customer. Amounts allocated to any material right are recognized as revenue when or as the related future goods or services are transferred or when the option expires.
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, other costs associated with clinical and preclinical activities and regulatory operations and acquisition of in process research and development write-offs. 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 consolidated financial statements as prepaid or accrued clinical trial costs, as the case may be.
Foreign Currencies
The Company’s consolidated financial statements are presented in U.S. dollars, the reporting currency of the Company. The financial position and results of operations of our subsidiaries are measured using the foreign subsidiaries’ local currency as the functional currency. These entities’ cash accounts holding U.S. dollars and intercompany payables and receivables are remeasured based upon the exchange rate at the date of remeasurement with the resulting gain or loss included in the consolidated statements of operations and comprehensive loss. Expenses of such subsidiaries have been translated into U.S. dollars at average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the consolidated balance sheet dates. The resulting translation gain and loss adjustments are recorded directly as a separate component of shareholders’ equity and as other comprehensive gain (loss) on the consolidated statements of operations and comprehensive loss.
Income Taxes
Income taxes are recorded in accordance with ASC 740,Income Taxes, or ASC 740, which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Realization of net deferred tax assets is dependent on future taxable income. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. Realization of net deferred tax assets is dependent on future taxable income (see Note 11).
The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.
As of December 31, 2025 and 2024, the Company recorded unrecognized tax positions of $2.7 million and $2.2 million, respectively. No interest and penalties have been accrued relative to the unrecognized tax positions.
The Company is required to estimate income taxes in each of the jurisdictions in which it operates.
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 share equivalents had been issued at the beginning of the year and if the additional ordinary shares were dilutive (treasury stock method). 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:
| | | | | |
|---|---|---|---|---|
| | | December 31, | | December 31, |
| | | 2025 | | 2024 |
| Share options | 7,859,338 | 8,232,587 | ||
| Restricted share units | | 6,184,250 | | 4,252,250 |
| Warrants | | 700,000 | | 700,000 |
| | 14,743,588 | 13,184,837 |
Other Comprehensive Gain (Loss)
Other comprehensive gain (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. The only component of other comprehensive gain (loss) impacting the Company is foreign currency translation.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance. The Company hasone reportable and operating segment, which is the development and manufacturing of genetic medicines, for purposes of reporting financial condition and results of operations. The Company’s chief operating decision maker (“CODM”) is the chief executive officer.
The accounting policies of its segment are the same as those described in the summary of significant accounting policies. The CODM allocates resources and assesses performance of the Company’s single reportable segment by regularly reviewing the segment net loss that also is reported on the consolidated statement of operations and comprehensive loss as net loss.
The following table sets forth information about the Company’s single reportable segment and the significant expenses reviewed by the CODM, including a reconciliation to net loss (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · For the Years Ended December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Service revenue - related party | | $6,400 | | $33,279 | ||
| License revenue | | 74,991 | | — | ||
| Operating expenses: | | | | | | |
| Cost of service revenue - related party | | | 4,843 | | | 23,791 |
| General and administrative | | 38,480 | | 39,389 | ||
| Clinical programs: | | | | | | |
| Botaretigene sparoparvovec | | | — | | | 1,250 |
| AAV-hAQP1 | | | 13,762 | | | 17,307 |
| AAV-CNGB3 / AAV-CNGA3 | | | — | | | (969) |
| AAV-GAD | | | 14,268 | | | 6,411 |
| Other ocular diseases | | | 4,380 | | | 1,763 |
| Manufacturing | | | 44,288 | | | 53,445 |
| Preclinical programs: | | | | | | |
| Gene regulation | | | 9,426 | | | 10,509 |
| Neurodegenerative diseases | | | 1,116 | | | 1,608 |
| Preclinical ocular diseases | | | 3,567 | | | 2,474 |
| Other research and development1 | | | 18,582 | | | 2,494 |
| Share-based compensation | | | 22,105 | | | 25,191 |
| Depreciation and amortization | | | 12,542 | | | 12,828 |
| Total operating expenses | | | 187,359 | | | 197,491 |
| Other segment items2 | | | (8,233) | | | 16,421 |
| Segment net loss | | $(114,201) | | | (147,791) | |
| Net loss | | $(114,201) | | $(147,791) | ||
1 Other research and development is comprised of all other costs including payroll and payroll related costs, travel, rent and facilities costs and other non-program specific expenses.
2 Other segment items is comprised of foreign currency gain (loss), interest income, interest expense and gain on sale of nonfinancial assets.
The Company’s service revenue – related party and deferred revenue – related party from the Asset Purchase Agreement and related agreements and license revenue from the Lilly Collaboration Agreement were generated in the United Kingdom.
The following table summarizes long-lived assets by geographical area (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| United States | | $8,830 | | $7,209 | ||
| United Kingdom | | 26,092 | | 28,419 | ||
| European Union | | | 107,589 | | | 100,845 |
| | | $142,511 | | $136,473 | ||
Recent Accounting Pronouncements Adopted
In December 2023, the FASB issued ASU 2023-09,Improvements to Income Tax Disclosures, which requires that an entity disclose specific categories in the effective tax rate reconciliation as well as provide additional information for reconciling items that meet a quantitative threshold. Further, the ASU requires certain disclosures of state versus federal income tax expense and taxes paid. This ASU is effective for annual periods beginning after December 15,
- The Company retrospectively adopted this standard in fiscal year 2025 and it did not have a material impact on the Company’s consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted
In October 2023, the FASB issued ASU 2023-06,Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This update includes a number of amendments to clarify or improve disclosure and presentation requirements of a variety of topics in order to allow users to more easily compare entities subject to the SEC’s existing disclosures with those entities that were not previously subject to the requirements and to align the requirements in the FASB accounting standard codification with the SEC’s regulations. The effective date for each amendment will be the date on which the SEC’s removal of that related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The Company is currently evaluating the impact of these amendments.
In November 2024, the FASB issued ASU No. 2024-03,Income Statement: Reporting Comprehensive Income: Expense Disaggregation Disclosures (Subtopic 220-40), which requires public business entities to disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. In January 2025, the FASB issued ASU No. 2025-01,Clarifying the Effective Date, which revised the effective date of ASU No. 2024-03 for interim periods. The guidance is effective for annual periods beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The Company is currently assessing the impact of ASU 2024-03 and ASU 2025-01 on its consolidated financial statements.
In July 2025, the FASB issued ASU 2025-05,Financial Instruments - Credit Losses (ASC 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets. This amendment introduces a practical expedient for the application of the current expected credit loss model to current accounts receivable and contract assets. The guidance is effective for annual periods beginning after December 15, 2025, and interim periods within those annual reporting periods. Early adoption is permitted. The Company is currently evaluating the impact of this ASU on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU 2025-07,Derivatives and Hedging (ASC 815) and Revenue from Contracts with Customers (ASC 606): Derivative Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract, which refines the scope of ASC 815 by clarifying which contracts are subject to derivative accounting and expands the scope exception for certain contracts not traded on an exchange to include contracts for which settlement is based on operations or activities specific to one of the parties to the contract. The guidance also provides clarification under ASC 606 for share-based payments from a customer in a revenue contract. The guidance is effective for annual periods beginning after December 15, 2026 and interim periods within those annual reporting periods. The Company does not expect any significant impact on its financial condition or results of operations upon adoption.
In December 2025, the FASB issued ASU 2025-10,Government Grants (ASC 832): Accounting for Government Grants Received by Business Entities. This update establishes guidance on the recognition, measurement, and presentation of government grants received by business entities. The new guidance leverages the principles in the accounting framework for government assistance in International Accounting Standard 20 “Accounting for Government Grants and Disclosure of Government Assistance.” The guidance is effective for interim periods within annual reporting periods beginning after December 15, 2028. Early adoption is permitted. The Company is currently evaluating the impact of this ASU on its consolidated financial statements and related disclosures.
In December 2025, the FASB issued ASU 2025-11,Interim Reporting (ASC 270) Narrow-Scope Improvements. This update clarifies interim disclosure requirements, including providing a comprehensive list of interim disclosure requirements under U.S. GAAP and a disclosure principle that requires entities to disclose events since the last annual reporting period that have a material impact on the entity. The guidance is effective for interim periods
within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company does not expect any significant impact on its financial condition or results of operations upon adoption.
In December 2025, the FASB issued ASU 2025-12,Codification Improvements, to update, correct, clarify and otherwise improve U.S. GAAP. The guidance is effective for annual reporting periods beginning after December 15, 2026, and for interim periods within those annual reporting periods. Early adoption is permitted as of the beginning of an annual reporting period and adoption can be applied prospectively or retrospectively, as well as on an issue-by-issue basis. The Company does not expect any significant impact on its financial condition or results of operations upon adoption.
3. Equity Method and Other Investments
The Company’s investments consist of the following (in thousands):
| · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · December 31, 2025 | ||||||||||
| Investee · · Investment Type · · Ownership Percentage · · Carrying Value · · Cost Basis | ||||||||||
| Visiogene LLC | | Equity Method Investment | | 25.0% | | $5,133 | | $5,165 | ||
| Other | | Equity Investment | | 0.8% | | | 1,616 | | | 1,500 |
| Total equity method and other investments | | | | | | | $6,749 | | $6,665 | |
| · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · December 31, 2024 | ||||||||||
| Investee · · Investment Type · · Ownership Percentage · · Carrying Value · · Cost Basis | ||||||||||
| Visiogene LLC | | Equity Method Investment | | 25.0% | | $5,133 | | $5,165 | ||
| Other | | Equity Investment | | 0.9% | | | 1,616 | | | 1,500 |
| Total equity method and other investments | | | | | | | $6,749 | | $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.
During the years ended December 31, 2025 and 2024, the Company recorded de minimis research and development expenses related to the Company’s share of Visiogene’s losses.
- Prepaid Expenses
Prepaid expenses at December 31, 2025 and 2024 consist of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Manufacturing costs | | $2,894 | | $1,826 | ||
| Dues and license fees | | | 901 | | | 1,253 |
| Insurance | | | 813 | | | 840 |
| Facilities costs | | 754 | | 657 | ||
| Clinical trial costs | | | 466 | | | 1,823 |
| Other | | 189 | | 429 | ||
| | | $6,017 | | $6,828 | ||
- Property, Plant and Equipment, net
Property, plant and equipment, net at December 31, 2025 and 2024 consist of the following (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | December 31, | | December 31, |
| | | 2025 | | 2024 |
| Leasehold improvements | | $107,793 | | $99,371 |
| Manufacturing equipment | | 26,073 | | 23,019 |
| Laboratory equipment | | 15,219 | | 14,741 |
| Computer and office equipment | | 8,158 | | 7,292 |
| Furniture and fixtures | | 851 | | 758 |
| | | 158,094 | | 145,181 |
| Less: Accumulated depreciation and amortization | | (52,629) | | (42,303) |
| | | $105,465 | | $102,878 |
Depreciation and amortization expense related to property, plant and equipment was $11.1 million and $11.4 million for the years ended December 31, 2025 and 2024, respectively.
As of December 31, 2025, property, plant and equipment with a carrying value of $5.5 million, consisting of $4.5 million leasehold improvements and $1 million manufacturing equipment, was not subject to depreciation, as these assets were not placed in service and not available for their intended use. As of December 31, 2024, property, plant and equipment with carrying value of $5.7 million, consisting of $3.8 million leasehold improvements, $1.7 million manufacturing equipment and $0.2 million laboratory equipment, was not subject to depreciation, as these assets were not placed in service and not available for their intended use.
| 6. | Intangible Assets, net |
In November 2020, the Company entered into a non-exclusive, royalty-free technology license agreement that required the Company to pay an upfront payment to the licensor of $2.1 million. The Company accounted for the transaction as an asset acquisition and recorded an intangible asset as it was determined to have alternative future uses in connection with the Company’s manufacturing capabilities.
The following table presents the details of the Company’s intangible assets as of December 31, 2025 and 2024 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Licensed Technology | | $2,110 | | $1,971 | ||
| Less: Accumulated amortization | | | (1,532) | | | (1,150) |
| | | $578 | | $821 | ||
The intangible asset is being amortized over a period ofseven years. Amortization expense of $0.3 million was recorded as a component of research and development expenses for each of the years ended December 31, 2025 and 2024, respectively.
As of December 31, 2025, the expected amortization expense for the next two years is as follows (in thousands):
| | | | |
|---|---|---|---|
| · · Amortization | |||
| · · Expense | |||
| 2026 | | $302 | |
| 2027 | | | 276 |
| Total amortization | | $578 | |
- Accrued Expenses
Accrued expenses at December 31, 2025 and 2024 were comprised of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · · 2025 · · 2024 | ||||||
| Compensation and benefits | | $12,810 | | $11,197 | ||
| Professional fees | | | 6,069 | | | 6,326 |
| Research and development | | 3,867 | | 2,234 | ||
| Manufacturing costs | | 3,378 | | 1,540 | ||
| Interest on Tranche 1 Notes | | | 2,710 | | | — |
| Clinical trial costs | | | 1,429 | | | 3,864 |
| Other | | | 2,630 | | | 2,253 |
| | | $32,893 | | $27,414 | ||
8. Other Current Liabilities
Other current liabilities at December 31, 2025 and 2024 were comprised of the following (in thousands):
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · December 31, · · December 31, | |||||
| · · 2025 · · 2024 | |||||
| Hologen Limited Upfront Payments | | $50,000 | | $— | |
| Other | | | 283 | | 903 |
| | | $50,283 | | $903 | |
- 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 Company’s 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. The number of shares available for issuance under the 2018 Incentive Award Plan are increased on January 1 of each calendar year beginning in 2019 and ending in and including 2028, by an amount equal to the lesser of (A)4% of the ordinary shares outstanding on the final day of the immediately preceding calendar year and (B) a smaller number of shares determined by the Company's board of directors. Under the 2018 Incentive Award Plan the Company initially reserved up to 3,054,996 shares for issuance, which has been increased to 16,790,683 as of December 31, 2025. As of December 31, 2025,617,248 shares remain available for future issuance. In January 2026, the number of shares available for issuance under the 2018 Incentive Award Plan increased by 3,244,837 shares.
Options
A summary of the Company’s share option activity related to employees, non-employee members of the board of directors and non-employee consultants as of and for the years ended December 31, 2025 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, 2024 | | 8,232,587 | | $12.57 | 5.35 | ||
| Granted | | 222,050 | | $6.07 | | ||
| Exercised | | (38,284) | | $6.73 | | ||
| Forfeited | | (557,015) | | $14.56 | | ||
| Outstanding at December 31, 2025 | | 7,859,338 | | $12.29 | | 4.58 | |
| Options exercisable at December 31, 2025 | | 7,116,750 | | $12.78 | | 4.25 | |
| Options vested and expected to vest at December 31, 2025 | | | 7,859,338 | | $12.29 | | 4.58 |
| Aggregate intrinsic value of options outstanding as of December 31, 2025 | | $4,039 | | | | | |
| Aggregate intrinsic value of options exercisable as of December 31, 2025 | | $3,370 | | | | | |
Options granted under the Plans have a maximum contractual term often 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 next annual meeting of shareholders after the date of grant.
The Company recorded the following share-based compensation expense in connection with the options for the years ended December 31, 2025 and 2024 (in thousands):
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Years Ended December 31, | |||||
| · · 2025 · · 2024 | |||||
| Research and development | | $3,375 | | $6,062 | |
| General and administrative | | 2,061 | | | 3,892 |
| Total share-based compensation | | $5,436 | | $9,954 | |
The total fair value of options vested during the years ended December 31, 2025 and 2024 was $5.9 million and $12.1 million, respectively.
The weighted average grant date fair value of options granted during the years ended December 31, 2025 and 2024 was $3.85 per share and $3.91 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 (see Note 2):
| · · · · | ||
|---|---|---|
| · · 2025 · · 2024 | ||
| Risk-free interest rate | 3.81 - 4.13% | 4.04 - 4.17% |
| Expected volatility | 78% | 67% |
| Expected dividend yield | 0% | 0% |
| Expected term (in years) | 6.01 | 3.6 - 6.1 |
As of December 31, 2025, the total compensation expense relating to unvested options granted that had not yet been recognized was $3.3 million, which is expected to be recognized over a period of 3.4 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 for the year ended December 31, 2025 is as follows:
| · · · · · · | |||||
|---|---|---|---|---|---|
| | | | | | Weighted- |
| · · Number of · · Average | |||||
| · · Restricted · · Grant Date | |||||
| · · Share Units · · Fair Value | |||||
| Outstanding at December 31, 2024 | | 4,252,250 | | $8.91 | |
| Granted | | 3,184,500 | | $6.17 | |
| Vested | | | (1,222,500) | | $11.52 |
| Forfeited | | | (30,000) | | $6.16 |
| Outstanding at December 31, 2025 | | 6,184,250 | | $7.00 | |
RSUs granted generally vest 50% on the second anniversary of the date of grant and 25% on the third andfourth 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 future years, the directors may elect whether to defer the payment of their annual RSU awards under the Deferred Compensation Plan for Non-Employee Directors, which was adopted by the board on December 17, 2021. As of December 31, 2025, there were 497,500 vested shares that have been deferred. 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 consolidated statements of operations and comprehensive loss.
The Company recorded the following share-based compensation expense in connection with the RSUs for the years ended December 31, 2025 and 2024 (in thousands):
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Years Ended December 31, | |||||
| · · 2025 · · 2024 | |||||
| Research and development | | $4,847 | | $5,070 | |
| General and administrative | | 11,822 | | | 10,167 |
| Total share-based compensation | | $16,669 | | $15,237 | |
As of December 31, 2025, the total compensation expense relating to unvested RSUs granted that had not yet been recognized was $24.7 million, which is expected to be recognized 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 years ended December 31, 2025 and 2024, the Company withheld 433,960 and 377,152 ordinary shares with a total value of approximately $3.0 million and $2.3 million, respectively. These amounts are presented as a cash outflow from financing activities in the accompanying consolidated statement of cash flows.
During the years ended December 31, 2025 and 2024 the Company recognized total share-based compensation expense in the accompanying consolidated statements of operations and comprehensive loss as follows (in thousands):
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Years Ended December 31, | |||||
| · · 2025 · · 2024 | |||||
| Research and development | | $8,222 | | $11,132 | |
| General and administrative | | 13,883 | | | 14,059 |
| Total share-based compensation | | $22,105 | | $25,191 | |
The Company does not expect to realize any tax benefits from its share option activity or the recognition of share-based compensation expense because the Company currently has net operating losses and has a full valuation allowance against its deferred tax assets. Accordingly, no amounts related to excess tax benefits have been reported in cash flows from operations or cash flows from financing activities for the years ended December 31, 2025 and 2024.
- Ordinary Shares
At-the-Market
In December 2023, the Company entered into an “at-the-market” sales agreement with BofA Securities, Inc., or BofA, pursuant to which the Company may sell from time to time, ordinary shares having an aggregate offering price of up to$100.0 million through BofA, acting as the Company’s agent. During the year ended December 31, 2025, the Company raised gross proceeds of$15.1 million through the sale of 2,121,883 ordinary shares pursuant to an “at-the-market” equity offering program. Under the “at-the-market” equity program which is currently effective and may remain available for the Company to use in the future, the Company may sell an additional$76.5 million of ordinary shares. Whether the Company chooses to affect future sales under the “at-the-market” equity offering program will depend on a number of factors, including, among others, market conditions and the trading price of the Company’s ordinary shares relative to other sources of capital.
At-the-Market
During the year ended December 31, 2024, the Company raised gross proceeds of$8.4 million through the sale of 1,508,517 ordinary shares pursuant to the same “at-the-market” equity offering program as noted above.
Equity Financing
On August 12, 2024, the Company entered into an underwriting agreement with BofA in connection with the issuance and sale by the Company in a public offering of 12,500,000 of the Company’s ordinary shares at a public offering price of$4.00 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333-276183) and a related prospectus supplement filed with the SEC. The closing of the offering occurred on August 13, 2024. The Company received gross proceeds from the offering of$50.0 million and incurred underwriting discounts and commissions and estimated offering expenses of approximately$1.9 million.
On August 12, 2024, the Company agreed to sell shares to an accredited investor (the “Investor”) through a private placement rather than through the public offering and as a result, on August 23, 2024, the Company entered into a securities purchase agreement with the Investor, pursuant to which the Company, in a private placement, agreed to issue and sell to the Investor 250,000 ordinary shares at a purchase price of$4.00 per share, for gross proceeds of$1.0 million (the “Private Placement”). The closing of the Private Placement occurred on August 29, 2024.
- Income Taxes
For the years ended December 31, 2025 and 2024, the Company recognized a tax benefit of $0.
As of December 31, 2025, the Company had U.S. federal and state net operating losses (“NOLs”) and foreign carryforward tax losses which are available to reduce future taxable income of (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | Federal | | State/City |
| United Kingdom | | $195,997 | | $— |
| United States | | $163,464 | | $23,432 |
| Ireland | | $118,071 | | $— |
| Other | | $36,698 | | $— |
All of the Company’s carryforward tax losses will be indefinitely carried forward, with the exception of federal U.S. NOLs in the amount of $0.2 million as of December 31, 2025, which will begin to expire in 2037 and state NOLs in the amount of $21.9 million as of December 31, 2025, which will begin to expire in 2036. Also, as of December 31, 2025, the Company had orphan drug and research and development credits in the U.S. in the amount of $27.2 million which will begin to expire in 2035 and research and development credits of $5.9 million in the UK which can be carried forward indefinitely. The U.S. NOLs and UK carryforward tax losses may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders, as defined under Section 382 of the Internal Revenue Code, as well as UK tax rules. This could limit the amount of NOLs and carryforward tax losses that the Company can utilize annually to offset future taxable income or tax
liabilities. As of December 2024, the Company had performed such an analysis and determined that there were no limitations in the UK and U.S.
The Company’s pre-tax income (loss) is as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, 2025 · · December 31, 2024 | ||||||
| United Kingdom | | $(16,284) | | $(62,760) | ||
| United States | | (65,531) | | (57,580) | ||
| Ireland | | | (30,193) | | | (25,762) |
| Other | | | (2,193) | | | (1,689) |
| | | $(114,201) | | $(147,791) | ||
The Company paidno income taxes (net of refunds received) for the years ended December 31, 2025 and 2024. Accordingly, no disaggregation by federal, state, or foreign jurisdiction is presented.
The Company is subject to the corporate tax rate in the UK as a limited UK corporation.
The following table summarizes a reconciliation of income tax benefit compared with the amounts at the UK statutory income tax rate (in thousands):
| | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2025 · · · · · December 31, 2024 · · | |||||||||||
| U.K. Statutory Tax Rate | | $(26,827) | | 25.00% | | | $(36,948) | | 25.00% | ||
| Foreign Tax Effects | | | | | | | | | | | |
| United States | | | | | | | | | | | |
| Statutory tax rate difference between United States and United Kingdom | | | 1,945 | | (1.81)% | | | | 1,621 | | (1.10)% |
| State and Local Income Taxes, Net of Federal Income Tax Effect | | | (188) | | 0.18% | | | | (634) | | 0.43% |
| Research and development tax credits | | | (4,253) | | 3.96% | | | | (3,352) | | 2.27% |
| Change in valuation allowance | | | 12,694 | | (11.83)% | | | | 11,405 | | (7.72)% |
| U.S. state change in ETR | | | 1,832 | | (1.71)% | | | | (309) | | 0.21% |
| Section 162(m) Adj. | | | 2,226 | | (2.07)% | | | | 1,568 | | (1.06)% |
| Share based compensation shortfall | | | 1,467 | | (1.37)% | | | | 2,221 | | (1.50)% |
| Other | | | 660 | | (0.62)% | | | | 1,875 | | (1.27)% |
| Ireland | | | | | | | | | | | |
| Statutory tax rate difference between Ireland and United Kingdom | | | 3,265 | | (3.04)% | | | | 3,134 | | (2.12)% |
| Change in valuation allowance | | | 3,265 | | (3.04)% | | | | 3,134 | | (2.12)% |
| Other | | | 1,018 | | (0.95)% | | | | 172 | | (0.12)% |
| Other Foreign Countries | | | | | | | | | | | |
| Statutory tax rate difference between other foreign countries and United Kingdom | | | 1 | | 0.00% | | | | (5) | | 0.00% |
| Change in valuation allowance | | | 938 | | (0.87)% | | | | 155 | | (0.11)% |
| Other | | | (357) | | 0.33% | | | | 272 | | (0.18)% |
| Tax Credits | | | (3,539) | | 3.30% | | | | 6,476 | | (4.38)% |
| Change in Valuation Allowances | | | 4,395 | | (4.10)% | | | | 9,344 | | (6.32)% |
| Nontaxable or Nondeductible Items | | | | | | | | | | | |
| Nondeductible interest | | | — | | 0.00% | | | | (4,105) | | 2.78% |
| Other | | | 837 | | (0.78)% | | | | 1,456 | | (0.99)% |
| Other Adjustments | | | 621 | | (0.58)% | | | | 2,520 | | (1.70)% |
| Actual income tax benefit effective tax rate | | $— | 0.00% | | | $— | 0.00% | ||||
The Expense/(Benefit) for income taxes from continuing operations consists of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, 2025 · · December 31, 2024 | ||||||
| Current Tax Expense/(Benefit) · · · · | ||||||
| United Kingdom | $— | $— | ||||
| United States | | — | | — | ||
| Ireland | | | — | | — | |
| Other | | | — | | | — |
| Total Current | $— | $— | ||||
| Deferred Tax Expense/(Benefit) | | | | | ||
| United Kingdom | $(4,395) | $(9,344) | ||||
| United States | | (12,694) | | (11,405) | ||
| Ireland | | | (3,265) | | | (3,134) |
| Other | | | (938) | | | (155) |
| Total Deferred | | (21,292) | | (24,038) | ||
| Change in Valuation Allowance | | 21,292 | | 24,038 | ||
| Total Income Tax Expense/(Benefit) | $— | $— | ||||
Deferred Tax Assets/(Liabilities) (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, 2025 · · December 31, 2024 | ||||||
| Deferred Tax Assets: | | | | | | |
| Net operating loss carryforwards | | $108,960 | | $85,308 | ||
| Interest expense | | | 11,657 | | | 6,736 |
| Capitalized research and development | | | 15,289 | | | 26,312 |
| Share-based compensation | | 11,700 | | | 11,921 | |
| R&D credit | | 30,417 | | | 22,160 | |
| Lease liability | | | 3,397 | | | 2,767 |
| Deferred tax assets | | 181,420 | | 155,204 | ||
| Less: valuation allowance | | (174,808) | | (149,382) | ||
| Deferred Tax Liabilities: | | | | | | |
| Depreciation | | | (2,729) | | | (2,192) |
| Right of use assets | | (2,696) | | | (2,099) | |
| Other | | (1,187) | | | (1,531) | |
| Net deferred tax liability | | $— | | $— | ||
ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance, after consideration of the reversal of the deferred tax liabilities for the ROU assets, fixed assets, and other deferred tax liabilities against its deferred tax assets at December 31, 2025 and 2024 because the Company's management has determined that it is more likely than not that these assets will not be fully realized.
As of December 31, 2025 and 2024, the Company recorded unrecognized tax positions of $2.7 million and $2.2 million, respectively. The unrecognized tax positions are netted with deferred tax assets above with a full valuation allowance. The changes to unrecognized tax positions for 2025 and 2024 were as follows (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | December 31, 2025 | | December 31, 2024 |
| Unrecognized tax benefits as of January 1 | $2,249 | $2,029 | ||
| Gross increases/(decreases) related to current year | | 459 | | 505 |
| Gross increases/(decreases) related to prior years | | 13 | | (285) |
| Unrecognized tax positions as of December 31 | $2,721 | $2,249 | ||
The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2025 and 2024, the Company hadno accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company's statements of operations and comprehensive loss.
The Company files income tax returns in the United States, UK, various foreign jurisdictions and various U.S. state jurisdictions. In the U.S., all years remain subject to examination. The earliest year subject to examination in the UK is 2022.
MeiraGTx Holdings plc is a UK tax resident with no earnings in its foreign subsidiaries and the Company does not expect any temporary basis difference in its investment in these subsidiaries to reverse in the foreseeable future. Therefore, the Company has not recorded deferred taxes on the outside basis difference in its foreign subsidiaries. It is not probable to compute the amounts, if any.
In July 2025, U.S. tax legislation known as the One Big Beautiful Bill Act, or OBBBA, was signed into law which makes permanent many of the tax provisions enacted in 2017 as part of the Tax Cuts and Jobs Act, or TCJA, that were set to expire at the end of 2025. Under OBBBA, domestic research and development costs incurred in tax years beginning after 2024 may be immediately deducted or, at the taxpayer’s election, capitalized and amortized. The OBBBA also provides several options for transitioning to the new rules for domestic research and development costs, including accelerated recovery of previously capitalized costs (beginning in 2025) for all taxpayers. Pursuant to TCJA Section 174, the Company elected to amortize its previously capitalized domestic research and development expenditures ratably over a two-year period. Following the enactment of Section 174A, the Company plans to adopt the revised method permitting the deduction of domestic research and development expenditures in the year incurred. Accordingly, domestic research and development expenses incurred during fiscal year 2025 were fully deducted for tax purposes. As the recent legislative changes did not modify the capitalization requirements applicable to foreign research and development expenditures, the Company evaluated its foreign research and development costs for the year ended December 31, 2025. The other provisions of the OBBBA did not have a material effect on the Company’s Consolidated Financial Statements for the fiscal year ended December 31, 2025.
- Related Party Transactions
Asset Purchase and Related Agreements with Johnson & Johnson Innovative Medicine
On December 20, 2023, the Company entered into the Asset Purchase Agreement with Johnson & Johnson Innovative Medicine pursuant to which the Company sold and assigned to Johnson & Johnson Innovative Medicine, and Johnson & Johnson Innovative Medicine purchased and assumed, the UCLB RPGR License Agreement relating to the research, development, manufacture and exploitation of the RPGR Product, and other related assets as described in the Asset Purchase Agreement. Simultaneously, the Company and Johnson & Johnson Innovative Medicine also entered into a Supply Agreement pursuant to which the Company agreed to manufacture and supply the RPGR Product for Johnson & Johnson Innovative Medicine. Under the Supply Agreement, Meira UK II, together with its affiliates, will manufacture commercial supply of the RPGR Product for Johnson & Johnson
Innovative Medicine for an initial term offour years, with Johnson & Johnson Innovative Medicine having an option to extend the Supply Agreement for a fifth year upon written notification. Johnson & Johnson Innovative Medicine may terminate the Supply Agreement for convenience upon 90 days’ written notice with payment of a termination fee. Under the Asset Purchase Agreement, Johnson & Johnson Innovative Medicine paid the Company a non-refundable upfront fee of $65.0 million in December 2023 and the Company is eligible to receive fees from commercial supply of the RPGR Product and in addition, milestones of up to $350.0 million, as follows: (i) a milestone payment of $50.0 million in connection with the achievement of the initiation of the extension study for the Phase 3 LUMEOS clinical trial for the RPGR Product; (ii) $10.0 million upon completion of certain specified development services for the drug substance for the RPGR Product; (iii) $5.0 million upon completion of certain specified development services for the drug product for the RPGR Product; (iv) $175.0 million upon the first commercial sale of an RPGR Product in the United States; (v) $75.0 million upon the first commercial sale of an RPGR Product in at least one of the United Kingdom, France, Germany, Spain and Italy; (vi) $25.0 million upon completion of the transfer of certain manufacturing technology for drug substance and drug product from the Company to Johnson & Johnson Innovative Medicine; and (vii) $10.0 million upon regulatory approval of a Johnson & Johnson Innovative Medicine-selected manufacturing facility in each of the United States and European Union for commercial manufacture of the RPGR Product. During 2024, the Company received $60.0 million in milestone payments from Johnson & Johnson Innovative Medicine. Johnson & Johnson Innovative Medicine is also responsible for any royalty or milestone amounts that become payable on the RPGR Product under the UCLB RPGR License Agreement.
Revenue Recognition under the Asset Purchase and Related Agreements
The agreements entered into in December 2023 were executed at the same time and were negotiated with a single commercial objective; therefore, the contracts were combined and accounted for as a single contract. These agreements were accounted for as a termination of the existing Collaboration Agreement and the creation of a new contract where the transaction price includes the remaining deferred revenue – related party from the terminated agreement of $30.6 million, the fixed upfront payment of $65.0 million under the Asset Purchase Agreement, and an aggregate of $1.8 million estimated variable consideration for transition services, offset by a credit of $5.1 million for pre-funded inventory, totaling $92.3 million. The transaction price was allocated to four performance obligations on a relative SSP basis, subject to certain exceptions for discounts and variable consideration. As the SSPs are not directly observable for any of the distinct goods and services, the SSPs were estimated based on a valuation. The total transaction price of $92.3 million was allocated to the performance obligations with respect to SSPs as follows: process performance qualification (“PPQ”) services in the amount of $2.9 million, net of future billings, material rights representing the commercial supply of RPGR Product and an in-substance contract renewal option in the amount of $6.9 million, manufacturing technology transfer in the amount of $28.7 million, and the sale of nonfinancial assets representing the sale and transfer of all the Company’s right, title, and interest in the intellectual property related to the RPGR Product and the assignment of the UCLB RPGR License Agreement to Johnson & Johnson Innovative Medicine in the amount of $53.8 million.
Since the commencement of the Asset Purchase Agreement and related agreements, the Company received a $50.0 million milestone payment in connection with the achievement of the initiation of the extension study for the Phase 3 LUMEOS clinical trial for the RPGR Product. The milestone payment was allocated to the four performance obligations on the same basis noted above increasing the value of each performance obligation as follows: PPQ services in the amount of $1.6 million, material rights representing the commercial supply of RPGR Product and an in-substance contract renewal option in the amount of $3.8 million, manufacturing technology transfer in the amount of $15.6 million, and the sale of nonfinancial assets representing the sale and transfer of all the Company’s right, title, and interest in the intellectual property related to the RPGR Product and the assignment of the UCLB RPGR License Agreement to Johnson & Johnson Innovative Medicine in the amount of $29.0 million. Additionally, the Company received a $10.0 million milestone payment in connection with the completion of certain specified development services for the drug substance for the RPGR Product which was allocated to the PPQ services performance obligation. The Company also entered into additional agreements to provide additional services under the Asset Purchase Agreement and related agreements amounting to an aggregate of $5.8 million which was
included in the transaction price and allocated to each of the respective performance obligations. Furthermore, the Company recorded certain changes in estimates related to the valuation of its performance obligations.
The transaction price allocated to PPQ services will be recognized over time using an inputs method measure of progress. The transaction price allocated to the material right for the commercial supply of RPGR Product will be recorded as deferred revenue – related party until Johnson & Johnson Innovative Medicine exercises its option to purchase supply and the Company transfers control of such supply to Johnson & Johnson Innovative Medicine. The transaction price allocated to the in-substance renewal option (material right) will be recorded as deferred revenue – related party until Johnson & Johnson Innovative Medicine exercises the option and the Company transfers control of the underlying goods or services to Johnson & Johnson Innovative Medicine. The Company will account for the exercise of the in-substance renewal option (material right) as a continuation of the existing contract (i.e., a change in the transaction price). The transaction price allocated to the technology transfer will be recognized over time using an inputs method measure of progress. The Company will recognize a gain for the difference between the carrying amount of the nonfinancial assets and the consideration allocated to that unit of account when control of the nonfinancial assets transfers in accordance with ASC 610-20,Other Income - Gains and Losses from the Derecognition of Nonfinancial Assets.
During the year ended December 31, 2024, the Company recognized a gain of $28.4 million related to the sale of nonfinancial assets which is included in other income in the consolidated statement of operations and comprehensive loss.
As of December 31, 2025, the aggregate transaction price allocated to unsatisfied performance obligations was $66.9 million which the Company expects to recognize over an estimated period of approximately 2.0 years.
A summary of the deferred revenue recognition is as follows (in thousands):
| | | | |
|---|---|---|---|
| Deferred revenue at December 31, 2024 | | $62,403 | |
| Other amounts collected or invoiced | | | 1,881 |
| Deferred revenue recognized as service revenue during the year ended December 31, 2025 | | | (2,635) |
| Effects of exchange rate changes | | | 5,247 |
| Deferred revenue at December 31, 2025 | | $66,896 |
During the year ended December 31, 2025 and 2024, the Company recognized $2.6 million and $14.0 million, respectively, of deferred revenue – related party as service revenue in connection with PPQ services under the Asset Purchase Agreement and related agreements.
During the years ended December 31, 2025 and 2024, $6.4 million and $33.3 million of service revenue, inclusive of the $2.6 million and $14.0 million, respectively, of deferred revenue – related party recognized as service revenue, was recognized based on cumulative progress of PPQ services under the Asset Purchase Agreement and related agreements.
Debt Financing
On August 2, 2022 the Company, as borrower, and Meira UK II and Meira Ireland, as guarantors (the “Subsidiary Guarantors”), entered into a senior secured financing arrangement (the “Financing Agreement”) by and among the Company, the Subsidiary Guarantors, the lenders and other parties from time to time party thereto and Perceptive Credit Holdings III, LP, as administrative agent and lender (“Perceptive”). On December 19, 2022, the Financing Agreement was converted to a notes purchase agreement and guaranty (the “Notes Purchase Agreement”) between the same parties and under substantially the same terms and conditions as the Financing Agreement, subject to certain customary note constitution terms. Perceptive Advisors, LLC, an affiliate of Perceptive, is a greater than 10.0% holder of the ordinary shares of the Company. Additionally, Ellen Hukkelhoven, Ph.D., a director of the
Company, is an employee of Perceptive Advisors, LLC. Refer to the discussion in Note 14 for further information related to the accounting for the debt financing.
On December 31, 2025, the Company entered into a share purchase agreement to repurchase 2,300,000 of its ordinary shares from Perceptive Life Sciences Master Fund, Ltd., an affiliate of Perceptive Advisors LLC, at a purchase price of $7.91 per share. The aggregate purchase price of $18.2 million was subject to satisfaction of certain conditions precedent to settlement, thereforeno liability was recognized as of December 31, 2025. The Company considered the obligation to be a contingent commitment, as the repurchase was contingent upon the conditions being met on settlement date. The transaction was settled on January 5, 2026
13. 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 and laboratory equipment. The Company’s leases have initial lease terms ranging from 1.5 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 recorded under these leases was $4.8 million and $5.6 million for the years ended December 31, 2025 and 2024, respectively.
The Company entered into a lease agreement for laboratory space in March 2025 with an initial lease term of 91 months. The Company also entered into a lease agreement for office space in July 2025 with an initial lease term of 39 months. The lease for the laboratory space contains provisions for tenant allowances and future rent increases. The Company took possession of both spaces in August 2025 and recognized initial operating lease right-of-use assets in the amount of $8.2 million and corresponding lease liabilities in the amount of $8.0 million, in connection with these leases, which are included in the right-of-use assets and lease obligations in the consolidated balance sheets as of December 31, 2025. The lease liabilities have been measured using the incremental borrowing rate (“IBR”) rather than the rate implicit in the lease agreements, as the implicit rates could not be readily determined. The IBR applied to both leases reflects the parent company’s borrowing rate as the Company considers it to be a more appropriate reflection of the financing rate that would be available to the consolidated group, rather than the rates specific to the subsidiary that is the lessee under the agreements. There wereno leases recognized during the year ended December 31, 2024. During the year ended December 31, 2025, the Company determined that it was reasonably certain to exercise its early termination option on an operating lease for laboratory and office space, resulting in a remeasurement of the ROU asset and lease liability reflected in the accompanying consolidated balance sheets. The lease was terminated August 31, 2025.
Eight clinical trial site leases were assigned to Johnson & Johnson Innovative Medicine during the year ended December 31, 2024 in connection with the Asset Purchase Agreement and related agreements.
The components of lease cost for the years ended December 31, 2025 and 2024 are as follows (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| · · Years Ended December 31, | ||||
| | | 2025 | | 2024 |
| Finance lease cost · · · · · | ||||
| Amortization of right-of-use assets | | $1,206 | | $981 |
| Interest on lease liabilities | | 11 | | — |
| Total finance lease cost | | 1,217 | | 981 |
| Operating lease cost | | 4,764 | | 5,630 |
| Short-term lease cost | | 604 | | 256 |
| Total lease cost | | $6,585 | | $6,867 |
Amounts reported in the consolidated balance sheets for leases where the Company is the lessee as of December 31, 2025 and 2024 were as follows (in thousands):
| · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, · | ||||||
| · · 2025 · · 2024 · | ||||||
| Operating leases · · · · · · · · | ||||||
| Right-of-use assets | | $12,852 | | | $10,576 | |
| Capitalized lease obligations | | $14,202 | | | $11,576 | |
| Finance leases | | | | | | |
| Right-of-use assets | | $23,616 | | | $22,198 | |
| Capitalized lease obligations | | $147 | | | $— | |
| Weighted-average remaining lease term | | | | | | |
| Operating leases | | 6.4 | years | | 3.6 | years |
| Finance leases | | 172.9 | years | | 173.9 | years |
| Weighted-average discount rate | | | | | | |
| Operating leases | | 11.2% | | 8.8% | ||
| Finance leases | | 13.0% | | 8.0% | ||
Other information related to leases as of the years ended December 31, 2025 and 2024 are as follows (in thousands):
| | | | | | |
|---|---|---|---|---|---|
| | Years Ended December 31, | ||||
| · 2025 · · 2024 | |||||
| Cash paid for amounts included in the measurement of lease liabilities · · · | |||||
| Operating cash flows from operating leases | $3,983 | | $5,408 | ||
| Financing cash flows from finance leases | $29 | | $— | ||
| | | | | | |
| Right-of-use assets obtained in exchange for lease liabilities | | | | ||
| Operating leases | $8,556 | | $— | ||
| Finance leases | $165 | | $— | ||
Future minimum lease payments under non-cancellable leases as of December 31, 2025 are as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Operating Leases · · Finance Leases | ||||||
| 2026 | | $4,468 | | $57 | ||
| 2027 | | 3,824 | | 57 | ||
| 2028 | | 3,474 | | 57 | ||
| 2029 | | 2,393 | | 14 | ||
| 2030 | | | 1,850 | | | — |
| Thereafter | | 4,201 | | — | ||
| Total undiscounted lease payments | | $20,210 | | $185 | ||
| Less: Imputed interest | | (6,008) | | (38) | ||
| Total lease liabilities | | $14,202 | | $147 | ||
14. Debt Financing
On August 2, 2022 the Company, and the Subsidiary Guarantors, entered into the Financing Agreement with Perceptive. On December 19, 2022, the Financing Agreement was converted to a Notes Purchase Agreement between the same parties and under substantially the same terms and conditions as the Financing Agreement, subject to certain customary note constitution terms. The Company and the Subsidiary Guarantors entered into a
Consent and Amendment with Perceptive on August 10, 2023 (the “First Consent and Amendment), and the Company and the Subsidiary Guarantors entered into a second Consent and Amendment with Perceptive on December 20, 2023 (the “Second Consent and Amendment”).
The Notes Purchase Agreement provides for an initial $75.0 million notes issuance (the “Tranche 1 Notes”). Pursuant to the First Consent and Amendment, the Company was able to request in its sole discretion, and Perceptive agreed to subscribe to purchase upon such request, an additional $25.0 million notes issuance (the “Tranche 2 Notes”) at any time before August 2, 2024 subject to the terms of the Notes Purchase Agreement. Previously, the Company’s request for issuance of the Tranche 2 Notes was to be determined at Perceptive’s sole discretion. Pursuant to an amendment to the Notes Purchase Agreement entered into on March 25, 2026 as further described in Note 17, the maturity date of the Notes Purchase Agreement has been extended from August 2, 2026 to May 2, 2027 and the Company has agreed to redeem a portion of the outstanding principal amount of the Tranche 1 Notes equal to $25.0 million on or before June 30, 2026. The Company has the option to redeem outstanding principal notes at any time along with an applicable early redemption fee. Under each of the First Consent and Amendment and the Second Consent and Amendment, the Notes Purchase Agreement was amended to increase the applicable early redemption fee. Outstanding amounts under the Notes Purchase 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 aone-month tenor, subject to a 1.00% floor. The annual interest rate was 14.14% at December 31, 2025. As of December 31, 2025, the outstanding balance of the Tranche 1 Notes was $75.0 million plus accrued interest of $2.7 million. During the years ended December 31, 2025 and 2024, the Company recorded interest expense of $10.9 million and $11.6 million, respectively.
The Company’s obligations under the Notes Purchase Agreement are secured by the Company’s London, UK and Shannon, Ireland manufacturing facilities, $3.0 million of the Company’s cash and the bank accounts of the Subsidiary Guarantors, and the issued and outstanding equity interests of the Subsidiary Guarantors.
The Notes Purchase Agreement imposes certain covenants and restrictions on the Company and the Subsidiary Guarantors, including restrictions pertaining to: (i) the incurrence of additional indebtedness, (ii) limitations on liens, (iii) limitations on certain investments, (iv) making distributions, dividends and other payments, (v) mergers, consolidations and acquisitions, (vi) dispositions of assets, (vii) the Company’s maintenance of at least $3.0 million in a U.S. bank account, (viii) transactions with affiliates, (ix) changes to governing documents, (x) changes to certain agreements and leases and (xi) changes in control; however, certain of these restrictions contain exceptions which allow the Company to license, sell and monetize assets in its AAV-hAQP1 program in development to treat radiation-induced xerostomia, its AAV-GAD program in development to treat Parkinson’s disease and its gene regulation platform technologies. As of December 31, 2025, the Company is in compliance with all covenants.
In connection with entering into the Financing Agreement, the Company granted warrants to Perceptive to purchase up to (i)400,000 ordinary shares of the Company at an exercise price of $15.00 per share and (ii)300,000 ordinary shares of the Company at an exercise price of $20.00 per share. Pursuant to the amendment on March 25, 2026, the warrants were amended to change the exercise price to $8.00 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 Notes Purchase Agreement totaling $2.1 million, which were recorded as a discount to the loan. The aggregate discount of $4.4 million is being amortized to interest expense over the term of the Notes Purchase Agreement. The Company amortized $1.1 million of the discount to interest expense during each of the years ended December 31, 2025 and 2024. At December 31, 2025, the remaining unamortized discount was $0.7 million.
- Commitments and Contingencies
The Company has filed claims for research and development tax credits in Ireland for the 2023 and 2024 fiscal years. The total potential benefit associated with the filed claims is approximately $7.3 million. These claims are currently under review by the Irish tax authorities. As this represents the Company’s first time claiming such credits in Ireland, and the ultimate approval, timing, and amount of any refund remains uncertain, the Company has not recognized a receivable or related income as of December 31, 2025. Any amounts ultimately approved and received will be recognized in the period in which realization becomes probable and reasonably estimable.
On December 31, 2025, the Company entered into a share purchase agreement to repurchase 2,300,000 of its ordinary shares from Perceptive Life Sciences Master Fund, Ltd., an affiliate of Perceptive Advisors LLC, at a purchase price of $7.91 per share. The aggregate purchase price of $18.2 million was subject to satisfaction of certain conditions precedent to settlement, thereforeno liability was recognized as of December 31, 2025. The Company considered the obligation to be a contingent commitment, as the repurchase was contingent upon the conditions being met on settlement date. The transaction was settled on January 5, 2026.
- Employee Benefit Plans
The Company maintains employee benefit plans for its employees, which vary by jurisdiction and are subject to local statutory and regulatory requirements. During the years ended December 31, 2025 and 2024, employer contributions to all plans were$2.7 million and$2.5 million, respectively.
United States
On January 1, 2017, Meira LLC adopted a defined contribution retirement plan that complies with Section 401(k) of the Internal Revenue Code. All Meira LLC employees over the age of 21 are eligible to participate in the plan after three consecutive months of service. Employees are able to defer a portion of their pay into the plan on the first day of the month or after the day all age and service requirements have been met. The plan provides for a Company matching contribution. All eligible employees receive an employer matching contribution equal to the lesser of the amount the employee contributes to the plan or 6% of their salary up to the annual IRS limit.
United Kingdom
On August 1, 2016, Meira UK II adopted a defined contribution group personal pension plan that complies with HMRC for tax relief. All Meira UK II employees are eligible to participate in the plan upon joining the company and providing the required services. All eligible employees, if they elect to join the pension scheme, receive an employer pension contribution equal to 7.5% to 10.0% of their pensionable earnings. Currently, employees are required to contribute 0.5%, to meet minimum legal pension funding levels of 8%, but may make optional contributions up to the annual allowance HMRC limits.
During 2025, certain employees transferred to Meira UK as part of an internal organizational change. In connection with these transfers, Meira UK adopted a pension plan that mirrors the Meira UK II defined contribution pension plan, with substantially similar eligibility criteria, contribution rates, and terms, to ensure continuity of employee benefits.
Ireland
On November 20, 2020, Meira Ireland adopted a defined contribution pension plan. All Meira Ireland employees are eligible to participate in the plan upon joining the Company. All eligible employees, if they elect to join the pension scheme, receive an employer pension contribution. The Company’s current contribution, exclusive of an employee match, is 4.5%, which exceeds Revenue Ireland requirements.
Belgium
Meira Belgium operates a defined contribution pension plan. All eligible employees receive an employer pension contribution of 8% of their annual salary. Employees do not make contributions to the plan.
17. Subsequent Event
On March 25, 2026, the Company, as issuer, and the Subsidiary Guarantors, the noteholders and other parties from time to time party to the Notes Purchase Agreement, and Perceptive, as administrative agent and lender under the Notes Purchase Agreement, entered into Amendment No. 4 to Amended and Restated Notes Purchase Agreement and Amendment No. 1 to Warrant Certificates (the “Amendments”). Under the Amendments, the maturity date of the Notes Purchase Agreement has been extended from August 2, 2026 to May 2, 2027 and the Company has agreed to redeem a portion of the outstanding principal amount of the Tranche 1 Notes equal to$25.0 million on or before June 30, 2026. The Warrants were amended to change the exercise price to$8.00 per share.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.