Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of financial condition and operating results together with our financial statements and related notes appearing in this Quarterly Report on Form 10-Q ("Form 10-Q") and those included in our Annual Report on Form 10-K for the year ended December 31, 2025 (the "Form 10-K"). Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many important factors, including those set forth in the "Risk Factors" section of this Form 10-Q, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis. For convenience of presentation some of the numbers have been rounded in the text below. Unless the context requires otherwise, references in this Management's Discussion and Analysis of Financial Condition and Results of Operations to the "Company," "we," "us" and "our" refer to MeiraGTx Holdings plc and its subsidiaries.

Overview

We are a vertically integrated, clinical-stage genetic medicines company with a broad pipeline of four late-stage clinical programs. Each of these programs uses local delivery of small doses, resulting in disease-modifying effects in both inherited and more common diseases, in the eye, radiation-induced xerostomia and Parkinson's disease. We use our innovative technology in optimization of capsids, promoters, and novel translational control elements to develop best-in-class, potent, safe viral vectors. Our broad pipeline is supported by end-to-end in-house manufacturing. We have built the most comprehensive manufacturing capabilities in the industry, including two that are licensed for good manufacturing practices ("GMP") viral vector production and a GMP Quality Control facility with clinical and commercial licensure. In addition, we have developed a proprietary manufacturing platform process over 10 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, we have developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation technology allows precise, dose-responsive control of gene expression by oral small molecules. We are focusing the riboswitch platform on the regulated in vivo delivery of metabolic peptides, including leptin, GLP-1, GIP, glucagon, amylin and PYY, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally, PNS targets addressing long-term intractable pain. We have developed the technology to apply genetic medicine to common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high.

Our discussion of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States ("GAAP"). Since our formation, we have devoted substantially all of our resources to developing our technology platform, establishing our GMP viral vector manufacturing facilities and our GMP production facility and developing manufacturing processes, advancing the product candidates in our ophthalmology, salivary gland and neurodegenerative disease programs, building our intellectual property portfolio, organizing and staffing our company, developing our business plan, raising capital, and providing general and administrative support for these operations. To date, we have financed our operations primarily with cash on hand and proceeds from the sales of our equity securities, debt financings, strategic collaborations and asset sales, including (i) upfront and milestone payments in connection with the Collaboration, Option and License Agreement with Janssen Pharmaceuticals, Inc. ("Janssen"), dated as of January 30, 2019, for the research, development and commercialization of gene therapies for the treatment of inherited retinal disease, which also provided us with research funding, (ii) the Asset Purchase Agreement, dated as of December 20, 2023, we entered into with Janssen (the "Original Asset Purchase Agreement") pursuant to which we sold to Janssen botaretigene sparoparvovec, or bota-vec, for the treatment of X-linked retinitis pigmentosa ("XLRP") related to mutations in the retinitis pigmentosa GTPase regulator gene (the "RPGR Product"), and other related assets as described in the Original Asset Purchase Agreement, (iii) the Framework Agreements (as defined below), each dated as of March 9, 2025, we and certain of our affiliates entered into with Hologen Limited ("Hologen") and certain of its affiliates as further described below, and (iv) the Strategic Collaboration and License Agreement, dated as of November 7, 2025 (the "Lilly Collaboration Agreement"), we entered into with Eli Lilly and Company ("Lilly") for the research, development and commercialization of genetic medicines in and related to the area of ophthalmology. As of September 30, 2026, we had cash, cash equivalents and

restricted cash of $186.8 million, as well as a total of $23.4 million billed and unbilled receivables from Lilly and Reogen in connection with research and development and transition services and contract manufacturing processes.

We are a clinical stage company and have not generated any product revenues to date. We have ongoing clinical development programs and a broad pipeline of preclinical programs. Since inception, we have incurred significant operating losses. Our net loss for the three-month periods ended September 30, 2026 and September 30, 2025 were $51.3 million and $50.5 million, respectively. Our net income for the nine-month period ended September 30, 2026 and net loss for the nine-month period ended September 30, 2025 were $63.1 million and $129.3 million, respectively. As of September 30, 2026, we had an accumulated deficit of $753.0 million. We do not expect to generate revenue from sales of products unless and until we successfully initiate and complete clinical development and obtain regulatory approval for any product candidates, or satisfy our third party obligations.

Our total operating expenses for the three-month periods ended September 30, 2026 and 2025 were $54.7 million and $46.5 million, respectively. For the nine-month periods ended September 30, 2026 and 2025, our total operating expenses were $172.8 million and $138.5 million, respectively. We expect to continue incurring costs associated with our clinical activities for AAV-hAQP1 for the treatment of radiation-induced xerostomia and bota-vec for the treatment of XLRP associated with mutations in the RPGR gene, as well as for AAV-GAD for the treatment of Parkinson's disease. Certain activities related to the AAV-GAD program are performed under our strategic collaboration with Hologen and are expected to generate service revenue that will fund the related development activities. We also expect to continue to incur costs relating to AAV-AIPL1 for the treatment of LCA4. Certain activities performed under the Lilly Collaboration Agreement and related agreements are expected to generate service revenue that will fund our development and manufacturing activities associated with the program. We also incurred expenses during the nine-month period ended September 30, 2026 and expect to continue to incur expenses related to research activities in additional therapeutic areas to expand our pipeline, developing our potentially transformative gene regulation technology, hiring additional personnel as needed in manufacturing, research, clinical operations, quality, commercialization and other functional areas, and associated cash and share-based compensation expense, as well as the further development of internal manufacturing capabilities and capacity and other associated costs including the management of our intellectual property portfolio.

We will require additional capital in the future, which we may raise through equity offerings (including our "at-the-market" equity offering program), debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources to enable us to complete the development and potential commercialization of our product candidates. Furthermore, we expect to continue incurring costs associated with being a public company. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative effect on our financial condition and our ability to pursue our business strategy. In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and harm our product candidate development efforts. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate certain of our research and development programs.

Based on our cash, cash equivalents, accounts receivable, accounts receivable - related party, unbilled receivables - related party, unbilled receivables and tax incentive receivable at September 30, 2026, together with the additional $95.0 million upfront payment due from Hologen and associated reimbursements, we estimate that such funds will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. This estimate does not include the $135.0 million in potential near-term cash consideration from Lilly upon achievement of certain development and regulatory approval milestones, or any subsequent tranches available under the Royalty Note Purchase Agreement. We have based these estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. See "Liquidity and Capital Resources." Because of the numerous risks and uncertainties associated with the development of our product candidates, any future product candidates, our platform and technology and because the extent to which we may enter into collaborations with third parties for development of any of our product candidates is unknown, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates.

Adequate additional funds may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Any future debt financing or preferred equity or other financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may require the issuance of warrants, which could potentially dilute your ownership interests.

If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce, or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Because of the numerous risks and uncertainties associated with drug development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenue from product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

Asset Purchase and Related Agreements with Janssen Pharmaceuticals, Inc.

On April 15, 2026 (the "Janssen Closing Date"), we and MeiraGTx Ocular UK Limited ("MeiraGTx Ocular") entered into and consummated an Asset Purchase Agreement (the "Asset Purchase Agreement") with Janssen pursuant to which Janssen sold and assigned to us, and we purchased and assumed, that certain License Agreement, dated February 5, 2019, by and between UCLB Business Plc (now UCL Ventures Ltd.) and Janssen (the "UCLB 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.

We made an upfront cash purchase price of $25.0 million to Janssen. Additionally, pursuant to and subject to the terms and conditions set forth in the Asset Purchase Agreement, we agreed to pay Janssen a one-time, future contingent consideration of $50.0 million upon both of the following milestones being achieved: (i) our or our affiliates' receipt of regulatory approval for an RPGR Product in the United States and (ii) aggregate net sales by us or our affiliates of all RPGR Products in the United States since the Janssen Closing Date first exceeds $250.0 million. We have also agreed to pay Janssen royalties, based on future net sales globally of the RPGR Product by us or our affiliates, in the mid-teens percentage of annual net sales for the RPGR Product commencing on or after July 1, 2029. Additionally, in the event we or any of our affiliates may receive payments from a third party if we or any of our affiliates grant any license or right to develop or commercialize any RPGR Product to such third party, we will pay a portion of upfront and milestone payments to Janssen, as well as make royalty payments to Janssen for a given RPGR Product based on (A) royalty payments we or our affiliates may receive from such third party (after deduction of any royalty payments due under the UCLB License Agreement) and (B) net sales of a given RPGR Product by such third party.

In connection with the entering into the Asset Purchase Agreement, we and Janssen entered into a Termination Agreement on the Janssen Closing Date (the "Termination Agreement") terminating the Original Asset Purchase Agreement pursuant to which we sold the RPGR Product to Janssen. The Termination Agreement also terminated that certain Supply Agreement, dated as of December 20, 2023 by and between MeiraGTx UK II and Janssen, and certain other documents related to the Original Asset Purchase Agreement.

Johnson & Johnson Innovation - JJDC, Inc. ("JJDC"), the investment arm of Johnson & Johnson and owner of Janssen, owns more than 5% of our outstanding shares. JJDC and Janssen have agreed not to sell or transfer any of our ordinary shares or securities convertible into, exchangeable for, or exercisable for our ordinary shares, for twelve months

after the Janssen Closing Date and following such twelve month period, if Janssen ever intends to sell our shares after the twelve month period, they will provide written notice to us at least five business days prior to taking any action.

Eli Lilly and Company Collaboration Agreement

On November 7, 2025 (the "Lilly Effective Date"), our affiliates MeiraGTx Ocular, MeiraGTx Limited and MeiraGTx UK II Limited ("MeiraGTx UK II"), entered into the Lilly Collaboration Agreement with Lilly for the research, development and commercialization of genetic medicines in and related to the area of ophthalmology. Under the Lilly Collaboration Agreement, MeiraGTx has granted Lilly exclusive, worldwide rights to research, develop and commercialize our 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. Additionally, 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 our proprietary riboswitch technology in the field of ophthalmological gene editing.

Under the terms of the Lilly Collaboration Agreement, we received an upfront payment of $75.0 million 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 own cost. We may also perform research, development and manufacturing services for Lilly under the Lilly Collaboration Agreement and related agreements, for which we are entitled to reimbursement in accordance with the applicable contractual terms. The Lilly Collaboration Agreement also provides for tiered royalties to be paid to MeiraGTx Ocular on future product sales.

Hologen Transactions

On March 9, 2025, we and certain of our affiliates entered into a strategic collaboration with Hologen and certain of its affiliates to advance the development of certain central nervous system gene therapy programs and to support the Company's manufacturing capabilities. 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, Hologen committed to provide an upfront cash payment of $200.0 million and up to an additional $230.0 million to finance the development of our AAV-GAD program in Parkinson's disease to commercialization, as well as other locally-delivered therapies in the central nervous system. As part of the strategic collaboration, we also received an aggregate of 500,000 Class A shares of Hologen at a nominal price. As of September 30, 2026, Hologen has funded $105.0 million of the upfront payment commitment.

The collaboration is governed by two framework agreements. The first, between the Company, MeiraGTx Neuro UK Limited ("MeiraGTx Neuro UK"), Reogen Limited (formerly Hologen Neuro AI Limited) ("Reogen"), and Hologen, relates to the management of the business and affairs of Reogen, including the research, development, manufacture and commercialization of our (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 Reogen Collaboration Agreement as further described below.

The second, between MeiraGTx Manufacturing Limited ("MeiraGTx Manufacturing"), MeiraGTx Limited and Hologen, provides for the management of the business and affairs of MeiraGTx Manufacturing, including Hologen's investment in MeiraGTx Manufacturing and its participation in funding the manufacturing business.

In April 2026, the parties completed the initial closing of the strategic collaboration and entered into amendments to the framework agreements to facilitate the initial funding and investment structures. As part of the initial closing, the Company, MeiraGTx Neuro UK, MeiraGTx Neuro I, LLC ("MeiraGTx Neuro US"), Reogen, Hologen Neuro AI UK Limited ("Hologen Neuro UK") and Hologen entered into the Collaboration and License Agreement, dated as of April 20, 2026 (the "Reogen Collaboration Agreement") pursuant to which MeiraGTx Neuro US granted to Reogen and Hologen Neuro UK, subject to the license granted by Reogen and Hologen Neuro UK back to MeiraGTx Neuro UK, exclusive, worldwide, royalty-free, fully paid-up licenses to certain of our intellectual property rights for the research, development, manufacture and commercialization of the Clinical Programs and the Delivery Device. The parties also completed Hologen's initial investment in MeiraGTx Manufacturing.

Following the initial closing, Hologen will fund an additional $95.0 million to satisfy the remaining portion of the upfront payments provided for under the framework agreements and the Reogen Collaboration Agreement. These funds will be used by Hologen to purchase (i) a portion of the Reogen shares held by MeiraGTx Neuro UK, such that following the purchase, MeiraGTx Neuro UK and Hologen are expected to hold 30% and 70% of the outstanding shares in Reogen, respectively, and (ii) additional shares in MeiraGTx Manufacturing from MeiraGTx Limited, such that following the purchase, Hologen will have increased its minority interest in MeiraGTx Manufacturing. The framework agreement relating to MeiraGTx Manufacturing also provides that, for twelve months after Hologen purchases all of its additional shares using a portion of the proceeds from the remaining amount of the upfront payment to be paid, Hologen will have an option to increase its ownership interest in MeiraGTx Manufacturing to up to 40%, subject to the terms and conditions of the framework agreement. If Hologen does not exercise the option during that twelve month period, then we have an option to purchase all of the shares of MeiraGTx Manufacturing held by Hologen for the same price that Hologen paid for such shares. We may exercise our option beginning on the third anniversary of the date Hologen purchases its additional shares in MeiraGTx Manufacturing and ending three years thereafter.

On September 29, 2026, the Company, MeiraGTx, LLC, MeiraGTx Neuro UK, MeiraGTx Neuro US, Reogen, Hologen Neuro UK and Hologen entered into an Amendment to the Collaboration and License Agreement and Device Assignment and Assumption Agreement (the "Device Assignment Agreement"), pursuant to which the Company assigned certain intellectual property relating to, and contractual rights associated with the development of, the Delivery Device to Reogen, and amended the Reogen Collaboration Agreement to reflect the foregoing.

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Recent Development Highlights and Anticipated Milestones

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Botaretigene Sparoparvovec (bota-vec) for the Treatment of X-Linked Retinitis Pigmentosa (XLRP):

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AAV2-hAQP1 for the Treatment of Radiation-Induced Xerostomia:

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AAV-GAD for the Treatment of Parkinson's Disease:

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AAV-AIPL1 for LCA4:

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Riboswitch Gene Regulation Technology Platform for in vivo Delivery:

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Corporate and Leadership Updates

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Components of Our Results of Operations

Service Revenue

Our service revenue consists of revenue recognized for services performed under collaboration arrangements with third parties. During the current period, service revenue primarily relates to contract manufacturing services provided to Lilly under the collaboration agreement and related agreements.

Service Revenue - Related Party

Our service revenue - related party consists of revenue recognized for services performed under collaboration arrangements with related parties. During the current period, service revenue - related party primarily relates to research and development services provided to Reogen and the recognition of the remaining deferred revenue associated with the Original Asset Purchase Agreement and related agreements with Janssen, as the remaining performance obligations were extinguished upon termination of the agreements. In the prior period, service revenue - related party primarily related to the PPQ services performed in connection with the Original Asset Purchase Agreement and related agreements.

License Revenue - Related Party

Our license revenue - related party consisted of the revenue recognized from the grant of intellectual property licenses under our collaboration arrangements. During the current period, license revenue - related party primarily relates to the licenses granted to Reogen for the Clinical Programs and the Delivery Device.

Operating Expenses

Operating expenses include the following:

Cost of Service Revenue

Our cost of services revenue consists of costs incurred in providing services under collaboration arrangements with third parties. During the current period, cost of service revenue primarily relates to contract manufacturing services performed for Lilly under the collaboration agreement and related agreements.

Cost of Service Revenue - Related Party

Our cost of service revenue - related party consists of costs incurred in providing services under collaboration agreements with related parties. During the current year, cost of service revenue -related party primarily relates to research and development services performed for Reogen. In the prior year cost of service revenue - related party primarily related to the PPQ services performed in connection with the Original Asset Purchase Agreement and related agreements.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in our executive, finance, legal, business development and administrative functions. General and administrative expenses also include legal fees relating to intellectual property and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and office facility-related expenses, which include direct depreciation costs.

We have incurred, and expect to continue to incur, increased expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements; director and officer insurance costs; and investor and public relations costs.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of our product candidates, and include:

We expense research and development costs as incurred.

Research and development activities are central to our business model. We expect to continue incurring increasing research and development costs associated with our clinical activities for AAV-hAQP1 for the treatment of radiation-induced xerostomia and bota-vec for the treatment of XLRP associated with mutations in the RPGR gene. We also expect to continue to incur expenses related to research activities in additional therapeutic areas to expand our pipeline and develop our potentially transformative gene regulation technology.

We cannot determine with certainty the duration and costs of future clinical trials of our product candidates or any other product candidate we may develop or if, when, or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we obtain marketing approval. We may never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of clinical trials and development of our existing product candidates or any other product candidate we may develop will depend on a variety of factors, including:

A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the U.S. Food and Drug Administration (the "FDA") or another U.S. or foreign regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development.

Other Non-Operating Income (Expense)

Other non-operating income (expense) includes the following:

Foreign Currency (Loss) Gain

Our condensed consolidated financial statements are presented in U.S. dollars, which is our reporting currency. The financial position and results of operations of our subsidiaries are measured using the foreign subsidiaries' local currency as the functional currency, either the pound sterling or the euro. 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 condensed consolidated statements of operations and comprehensive (loss) income.

Interest Income

Interest income is comprised of interest earned on our interest-bearing bank accounts.

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Financial Related Costs, net

Financial related costs, net consist primarily of financing costs expensed in connection with the Royalty Notes, changes in the fair value of the Royalty Notes, as well as interest expense, and amortization of the debt discount in connection with the Notes Purchase Agreement. The Notes Purchase Agreement and Royalty Notes are further described in Note 12 to our unaudited condensed consolidated financial statements elsewhere in this Form 10-Q.

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Other Income (Expense)

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Other income (expense) primarily reflects changes in the fair value of the contingent forward instrument, derivative liability, and equity option instrument. The derivative liability relates to the contractual right granted to Oberland Capital Management LLC ("Oberland Capital") under the Securities Purchase Agreement as further described in Note 12 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q. Other expense also includes a non-cash loss resulting from the initial recognition of the derivative liability at fair value upon execution of the agreement.

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Loss on Equity Method Investee

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Loss on equity method investee represents our share of the operating results of Reogen, which is accounted for under the equity method of accounting. The amount reflects our proportionate share of Reogen's net loss for the reporting period.

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Income Tax Expense

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Income tax expense represents current and deferred income taxes recognized on our earnings and losses for the period, including the impact of valuation allowances and discrete tax items.

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Other Comprehensive (Loss) Gain

Other comprehensive (loss) gain includes the following:

Foreign Currency Translation Gain (Loss)

Revenue and expenses of 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 condensed consolidated balance sheet date. The resulting translation gain and loss adjustments are recorded directly as a separate component of shareholders' equity and as other comprehensive (loss) gain on the condensed consolidated statements of operations and comprehensive (loss) income.

Net Loss Attributable to Non-Controlling Interest

Net loss attributable to non-controlling interests represents the portion of losses attributable to equity interests in subsidiaries that are not wholly-owned by us. During the current period, non-controlling interests primarily related to Hologen's minority ownership interest in MeiraGTx Manufacturing following the initial closing of the strategic collaboration.

Critical Accounting Policies and Use of Estimates

Management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgements that affect the reporting amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgements, including those related to measurement of progress towards satisfaction of performance obligations, share-based compensation and accrued expenses. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying value of assets and liabilities that are not readily apparent from our sources. Actual results may differ from these estimates under different assumptions.

The Company's critical accounting policies, significant judgements and estimates are included in the Company's Form 10-K for the year ended December 31, 2025 and Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q.

Results of Operations

Comparison of Three Months Ended September 30, 2026 and 2025

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Service Revenue

Service revenue was $1.6 million for the three months ended September 30, 2026, compared to nil for the three months ended September 30, 2025. The increase of $1.6 million was due to revenue recognized for the contract manufacturing services provided to Lilly, as well as other support services related to the AAV-AIPL1 program, under the Lilly Collaboration Agreement and related agreements.

Service Revenue - Related Party

Service revenue - related party was $3.2 million for the three months ended September 30, 2026, compared to $0.4 million for the three months ended September 30, 2025. The increase of $2.8 million was primarily attributable to the development and transition services provided to Reogen under the Reogen Collaboration Agreement and related agreements in the current period, compared to PPQ services provided to Janssen under the Original Asset Purchase Agreement and related agreements in 2025.

Cost of Service Revenue

Cost of service revenue was $0.6 million for the three months ended September 30, 2026 compared to nil for the three months ended September 30, 2025. The increase of $0.6 million was attributable to costs incurred during the three months ended September 30, 2026 in connection with contract manufacturing services provided to Lilly, as well as other related costs associated with support services for the AAV-AIPL1 program under the Lilly Collaboration Agreement and related agreements.

Cost of Service Revenue - Related Party

Cost of service revenue - related party was $2.8 million for the three months ended September 30, 2026 compared to $0.3 million for the three months ended September 30, 2025. The increase of $2.5 million was primarily attributable to costs incurred during the current period related to the development and transition services provided to

Reogen under the Reogen Collaboration Agreement and related agreements, compared to costs associated with PPQ services provided to Janssen under the Original Asset Purchase Agreement and related agreements in 2025.

General and Administrative Expenses

General and administrative expenses were $12.0 million for the three months ended September 30, 2026, compared to $13.6 million for the three months ended September 30, 2025. The decrease of $1.6 million was primarily due to $1.2 million decrease in legal fees, $0.9 million decrease in facilities costs, $0.3 million decrease in consulting fees, and a $0.8 million decrease resulting from the allocation of certain general and administrative expenses to cost of service revenue and cost of service revenue - related party. These decreases were partially offset by $1.6 million increase in personnel costs.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2026 and 2025 were as follows (in thousands):

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Clinical program expenses represent the direct costs for each clinical trial plus the cost of the clinical trial material charged from the manufacturing costs.

Manufacturing expenses represent the costs to manufacture clinical trial material, including payroll, facilities, manufacturing supplies, raw materials, quality control and quality assurance. Upon completion of the manufacture of a batch of clinical trial material, the standard cost of manufacturing the batch of clinical trial material is charged to the clinical programs.

Preclinical program expenses represent the direct costs for each group of preclinical programs.

Other research and development expenses represent costs that are not allocated to a specific clinical or preclinical program, such as payroll and payroll related costs, share-based compensation, travel, rent and facilities costs, depreciation and other non-program specific expenses.

Research and development expenses were $39.3 million for the three months ended September 30, 2026, compared to $32.5 million for the three months ended September 30, 2025. The increase of $6.8 million was primarily attributable to increased clinical trial activities and manufacturing of clinical trial batch material related to our AAV-hAQP1 program, higher expenses associated with our bota-vec program following its reacquisition from Janssen in the

second quarter of 2026, and increased costs associated with our AAV-GAD program, primarily due to the allocation of manufacturing batch costs that were not recognized in cost of service revenue - related party. Manufacturing costs also increased primarily due to scheduled maintenance activities during the quarter, although this increase was fully offset by lower expenses associated with other preclinical ocular programs. In addition, expenses associated with other clinical ocular programs decreased.

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Foreign Currency (Loss) Gain

Foreign currency loss was de minimis for the three months ended September 30, 2026 compared to a loss of $1.6 million for the three months ended September 30, 2025. The $1.6 million decrease in foreign currency loss was primarily due to the fluctuations in exchange rates, including the weakening of the U.S. dollar against the pound sterling and the strengthening against the euro which impacted the remeasurement of our intercompany payables and receivables.

Interest Income

Interest income was $1.2 million for the three months ended September 30, 2026 compared to $0.2 million for the three months ended September 30, 2025. The increase of $1.0 million was due to higher cash balances in interest bearing accounts during 2026 offset by lower interest rates.

Financial Related Costs, net

Financial related costs, net reflected a gain of $1.6 million for the three months ended September 30, 2026 compared to an expense of $3.1 million for the three months ended September 30, 2025. The favorable change of $4.7 million was primarily due to a gain from the change in fair value of the Royalty Notes and lower interest expense following the termination of the Notes Purchase Agreement in the second quarter of 2026 as further described in Note 12 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q, partially offset by the transaction cost expensed in connection with the issuance of the Royalty Notes and subsequent change in fair value.

Other Income

Other income was $0.4 million for the three months ended September 30, 2026 compared to nil for the three months ended September 30, 2025. The increase was primarily attributable to a $0.8 million gain from the change in fair value of the derivative liability associated with the right granted under the Securities Purchase Agreement with Oberland Capital and a $0.4 million gain from the change in fair value of the equity option instrument, partially offset by a $0.8 million loss from the change in fair value of the contingent forward instrument.

Loss on Equity Method Investee

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Loss on equity method investee was $3.9 million for the three months ended September 30, 2026, compared to nil for the three months ended September 30, 2025. The loss primarily reflects the Company's proportionate share of Reogen's expenses associated with the ongoing research and development activities relating to the Reogen Collaboration Agreement.

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Income Tax Expense

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Income tax expense was $0.6 million for the three months ended September 30, 2026 compared to nil for the three months ended September 30, 2025. The increase of $0.6 million was primarily driven by changes in assumptions used to estimate the annual effective tax rate based on the Company's forecasted results for the full year.

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Comparison of Nine Months Ended September 30, 2026 and 2025

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Service Revenue

Service revenue was $13.5 million for the nine months ended September 30, 2026, compared to nil for the nine months ended September 30, 2025. The increase of $13.5 million was due to revenue recognized for the contract manufacturing services provided to Lilly, as well as other support services related to the AAV-AIPL1 program, under the Lilly Collaboration Agreement and related agreements.

Service Revenue - Related Party

Service revenue - related party was $108.4 million for the nine months ended September 30, 2026, compared to $6.0 million for the nine months ended September 30, 2025. The increase of $102.4 million was due to the recognition of related party deferred revenue following the termination of the Original Asset Purchase Agreement and Supply Agreement with Janssen and the development and transition services provided to Reogen under the Reogen Collaboration Agreement and related agreements which is partially offset by the decreased activity of PPQ services under the Original Asset Purchase Agreement and related agreements as the agreement was terminated in the second quarter of 2026 and the work was substantially completed in the first half of 2025.

License Revenue - Related Party

License revenue - related party was $204.6 million for the nine months ended September 30, 2026, compared to nil for the nine months ended September 30, 2025. The increase of $204.6 million was due to revenue recognized for the licenses granted to Reogen for the Clinical Programs and the Delivery Device.

Cost of Service Revenue

Cost of service revenue was $2.0 million for the nine months ended September 30, 2026 compared to nil for the nine months ended September 30, 2025. The increase of $2.0 million was due to costs related to contract manufacturing services provided to Lilly, as well as other related costs associated with support services for the AAV-AIPL1 program under the Lilly Collaboration Agreement and related agreements.

Cost of Service Revenue - Related Party

Cost of service revenue - related party was $8.8 million for the nine months ended September 30, 2026 compared to $4.4 million for the nine months ended September 30, 2025. The increase of $4.4 million was due to the development and transition services provided to Reogen under the Reogen Collaboration Agreement and related agreements, partially offset by the decreased activity of PPQ services provided to Janssen under the Original Asset Purchase Agreement and related agreements as the agreement was terminated during the second quarter of 2026 and the work was substantially completed in the first half of 2025.

General and Administrative Expenses

General and administrative expenses were $32.9 million for the nine months ended September 30, 2026, compared to $35.3 million for the nine months ended September 30, 2025. The decrease of $2.4 million was primarily due to a $2.0 million decrease in legal fees, $0.8 million decrease in facilities costs and a $0.8 million decrease resulting from the allocation of certain general and administrative expenses to cost of service revenue and cost of service revenue - related party. In addition, the prior year included a $1.3 million release of asset retirement obligation provisions related to U.S. office and laboratory leases, which did not recur in the current period.

Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2026 and 2025 were as follows (in thousands):

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Clinical program expenses represent the direct costs for each clinical trial plus the cost of the clinical trial material charged from the manufacturing costs.

Manufacturing expenses represent the costs to manufacture clinical trial material, including payroll, facilities, manufacturing supplies, raw materials, quality control and quality assurance. Upon completion of the manufacture of a batch of clinical trial material, the standard cost of manufacturing the batch of clinical trial material is charged to the clinical programs.

Preclinical program expenses represent the direct costs for each group of preclinical programs.

Other research and development expenses represent costs that are not allocated to a specific clinical or preclinical program, such as payroll and payroll related costs, share-based compensation, travel, rent and facilities costs, depreciation and other non-program specific expenses.

Research and development expenses were $129.1 million for the nine months ended September 30, 2026, compared to $98.8 million for the nine months ended September 30, 2025. The increase of $30.3 million was primarily attributable to the reacquisition of bota-vec under the Asset Purchase Agreement and increased costs associated with the

AAV-hAQP1 clinical program, including the manufacturing of clinical trial batch material. These increases were partially offset by lower manufacturing costs, primarily due to increased allocations of manufacturing batch costs to clinical programs and cost of service revenue. In addition, other research and development expenses increased due to higher employee and employee-related costs, facilities costs and other general research and development expenses. These increases were partially offset by lower expenses associated with the AAV-GAD program and other ocular programs, reflecting the allocation of clinical batch manufacturing costs to these programs in 2025, whereas certain costs associated with the AAV-GAD program are now recognized in cost of service revenue rather than research and development expenses. Expenses associated with other ocular programs also decreased. Preclinical program expenses decreased primarily due to the completion of certain gene regulation studies in 2025.

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Foreign Currency (Loss) Gain

Foreign currency loss was $4.3 million for the nine months ended September 30, 2026 compared to a gain of $10.8 million for the nine months ended September 30, 2025. The $15.1 million decrease in foreign currency loss was primarily attributable to fluctuations in exchange rates, including the weakening of the U.S. dollar against the pound sterling and strengthening against the euro as it relates to the valuation of our intercompany payables and receivables.

Interest Income

Interest income was $2.0 million for the nine months ended September 30, 2026 compared to $1.5 million for the nine months ended September 30, 2025. The increase of $0.5 million was due to higher cash balances held in interest bearing accounts during the second and third quarters of 2026.

Financial Related Costs, net

Financial related costs, net was $4.7 million for the nine months ended September 30, 2026 compared to $9.1 million for the nine months ended September 30, 2025. The decrease of $4.4 million was primarily due to lower interest expense following the termination of the Notes Purchase Agreement in the second quarter of 2026 as further described in Note 12 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q, and a gain from the change in fair value of the Royalty Notes, partially offset by the transaction cost expensed in connection with the issuance of the Royalty Notes and subsequent change in fair value.

Other Expense

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Other expense was $4.9 million for the nine months ended September 30, 2026 compared to nil for the nine months ended September 30, 2025. The increase was primarily attributable to a $5.3 million non-cash loss recognized upon the initial recognition of the derivative liability associated with the right granted under the Securities Purchase Agreement with Oberland Capital and a $0.8 million loss from the change in fair value of the contingent forward instrument. These losses were partially offset by a $0.8 million gain from the change in fair value of the derivative liability and a $0.4 million gain from the change in fair value of the equity option instrument.

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Loss on Equity Method Investee

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Loss on equity method investee was $75.8 million for the nine months ended September 30, 2026, compared to nil for the nine months ended September 30, 2025. The loss primarily reflects the Company's proportionate share of Reogen's expense associated with the acquired in-process research and development assets relating to the Clinical Programs and the Delivery Device, as well as Reogen's ongoing research and development activities under the Reogen Collaboration Agreement.

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Income Tax Expense

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Income tax expense was $3.0 million for the nine months ended September 30, 2026 compared to nil for the nine months ended September 30, 2025. The increase of $3.0 million was primarily attributable to higher forecasted taxable income, driven by strategic collaboration transactions and changes in assumptions used to determine the estimated annual effective tax rate applied to year-to-date results.

Liquidity and Capital Resources

Since our inception, we have incurred significant operating losses. For the nine months ended September 30, 2026, we had $45.3 million used by cash flows from operations. There are no assurances that we will generate positive cash flows in the future. Additionally, there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our product candidates. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical and clinical development of our product candidates. We expect that our research and development and general and administrative costs will increase in connection with conducting preclinical studies and clinical trials for our product candidates, building out internal capacity to have products manufactured to support preclinical studies and clinical trials as well as to manufacture commercial products, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result of these incurred and expected expenses we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

We do not currently have any approved products and have never generated any revenue from product sales. We have historically financed our operations primarily through cash on hand and proceeds from the sale of our equity securities, issuance of debt and upfront and milestone payments from our collaboration and business development activities and asset sales.

Based on our current cash, cash equivalents, accounts receivable, accounts receivable - related party, unbilled receivables - related party, unbilled receivables and tax incentive receivable at September 30, 2026, together with the additional $95.0 million upfront payment due from Hologen and associated reimbursements, we estimate that such funds will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. This estimate does not include the $135.0 million in potential near-term cash consideration from Lilly upon achievement of certain development and regulatory approval milestones, or any subsequent tranches available under the Royalty Note Purchase Agreement. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Cash Flows

As of September 30, 2026 we had $186.75 million of cash, cash equivalents and restricted cash.

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The following table summarizes our sources and uses of cash, cash equivalents and restricted cash for the period presented:

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Operating Activities

During the nine months ended September 30, 2026, net cash used in operating activities was $45.3 million. This primarily reflects a net income of $63.1 million, which was driven by revenue recognized for the licenses granted for the Clinical Programs and the Delivery Device to Hologen, partially offset by a net total of $32.5 million non-cash adjustments. These non-cash adjustments included $105.0 million of non-cash consideration received from related party - revenue arrangement, $75.8 million of undistributed losses of equity method investee, $27.7 million of acquired in-

process research and development, $15.1 million of share-based compensation, $8.7 million of depreciation and amortization, $4.9 million of gain in non-cash other income, $3.1 million of loss in non-cash financing related costs, $4.3 million of foreign exchange losses, $1.9 million of change in right-of-use assets, $1.5 million of loss on disposal of equipment, furniture and fixtures, and $0.7 million of amortization of debt discount. In addition, changes in working capital affected operating cash flows, with operating assets decreasing by $35.9 million and operating liabilities decreasing by $105.0 million.

During the nine months ended September 30, 2025, our cash used in operating activities of $93.0 million was primarily due to a net loss of $129.3 million as we incurred expenses associated with research activities on our clinical programs, manufacturing of our clinical trial materials, preclinical research programs and general and administrative expenses. The net loss included non-cash income and expense of $12.8 million, which consisted primarily of $16.5 million of share-based compensation, $9.4 million of depreciation and amortization, $0.8 million of amortization of debt discount, $10.8 million of a foreign exchange gain, $2.2 million of change in right-of-use assets and $1.5 million of gain on termination of lease liabilities. Additionally, operating assets, consisting of accounts receivable - related party, contract assets - related party, inventory, prepaid expenses, tax incentive receivable, other assets and other current assets, increased by $1.2 million and operating liabilities, consisting of accounts payable, accrued expenses, other current liabilities and deferred revenue - related party, increased by $22.3 million.

Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2026 was $27.6 million. This primarily consisted of $24.2 million used for the acquisition of in-process research and development assets and $4.1 million of purchases of property and equipment for our manufacturing, laboratory and process development facilities, partially offset by $0.7 million of proceeds from the sale of a non-controlling interest in MeiraGTx Manufacturing to Hologen.

Net cash used in investing activities for the nine months ended September 30, 2025 of $3.0 million consisted of purchases of property and equipment for our manufacturing, laboratory and process development facilities.

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Financing Activities

Net cash provided by financing activities was $191.6 million for the nine months ended September 30, 2026, consisting of $170.8 million net proceeds from the issuance of our ordinary shares, and $125.0 million proceeds from the Royalty Notes and $1.4 million exercise of stock options, partially offset by payment of the $75.0 million outstanding principal under the Notes Purchase Agreement, $18.2 million to repurchase 2.3 million of our ordinary shares from Perceptive Life Sciences Master Fund, Ltd. pursuant to a share purchase agreement, $6.5 million of costs associated with the issuance of ordinary shares and $6.0 million paid to satisfy tax withholding obligations upon the vesting of restricted share unit awards.

Net cash provided by financing activities was $6.9 million for the nine months ended September 30, 2025, which consisted of $9.9 million net proceeds from an "at-the-market" offering of our ordinary shares, offset by the payment of $3.0 million to cover tax withholding obligations upon the vesting of restricted share unit awards.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements under applicable SEC rules and do not have any holdings in variable interest entities.