XML 19 R7.htm IDEA: XBRL DOCUMENT
v3.26.1

Organization and Basis of Presentation | 3 Months Ended
--- | ---
Mar. 31, 2026
Organization and Basis of Presentation |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation The Company MeiraGTx Holdings plc and subsidiaries (the “Company” or “Meira Holdings”), an exempted company incorporated under the laws of the Cayman Islands, is a vertically integrated, clinical-stage 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, Parkinson’s disease and radiation-induced xerostomia. The Company uses its innovative technology in optimization of capsids, promoters, and novel translational control elements to develop best-in-class, potent, safe viral vectors. The Company’s broad pipeline is supported by end-to-end in-house manufacturing. The Company has 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, the Company has developed a proprietary manufacturing platform process over 9 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, the Company has developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation platform technology allows precise, dose-responsive expression of gene expression by oral small molecules. The Company is focusing the riboswitch platform on regulated in vivo delivery of metabolic peptides, including GLP-1, GIP, glucagon, amylin, PYY and leptin, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally, PNS targets addressing long-term intractable pain. The Company has 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. Asset Purchase and Related Agreements with Janssen Pharmaceuticals, Inc. On April 15, 2026 (the “Janssen Closing Date”), the Company and Meira Ocular (collectively, the “Buyer”), entered into and consummated an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Janssen Pharmaceuticals, Inc., a Pennsylvania corporation (“Seller” or “Janssen”), pursuant to which Seller sold and assigned to Buyer, and Buyer purchased and assumed, that certain License Agreement, dated February 5, 2019, by and between UCLB Business Plc (now UCL Business Ltd.) and Janssen (the “UCLB License Agreement”), relating to the research, development, manufacture and exploitation of Seller’s gene therapy product for the treatment of X-linked retinitis pigmentosa associated with mutations in the RPGR gene (the “RPGR Product”), and other related assets as described in the Asset Purchase Agreement. Buyer agreed to pay an upfront cash purchase price of $25.0 million to Seller. Additionally, pursuant to and subject to the terms and conditions set forth in the Asset Purchase Agreement, Buyer agreed to pay Seller a one-time, future contingent consideration of $50.0 million upon both of the following milestones being achieved: (i) Buyer’s or its affiliates’ receipt of regulatory approval for an RPGR Product in the United States and (ii) aggregate net sales by Buyer or its affiliates of all RPGR Products in the United States since the Janssen Closing Date first exceeds $250.0 million. Buyer has also agreed to pay Seller royalties, based on future net sales globally of the RPGR Product by Buyer or its affiliates, in the mid-teens percentage of annual net sales for the RPGR Product commencing on or after July 1, 2029. Additionally, Buyer will pay a portion of upfront and milestone payments to Seller in the event Buyer or any of its affiliates may receive payments from a third party if Buyer or any of its affiliates grant any license or right to develop or commercialize any RPGR Product to such third party, as well as make royalty payments to Seller for a given RPGR Product based on (A) royalty payments Buyer or its 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 Seller and Buyer entering into the Asset Purchase Agreement, Seller and Buyer entered into a Termination Agreement on the Janssen Closing Date (the “Termination Agreement”) terminating that certain Asset Purchase Agreement, dated as of December 20, 2023 (the “Original Asset Purchase Agreement”), by and among Seller and Buyer and Meira UK II, pursuant to which Buyer and Meira UK II sold the RPGR Product to Janssen. The Termination Agreement also terminated that certain Supply Agreement, dated as of December 20, 2023 by and between Meira UK II and Seller (the “Supply Agreement”), 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 Seller, owns more than 5% of the Company’s outstanding shares. JJDC and Seller have agreed not to sell or transfer any of the Company’s ordinary shares or securities convertible into, exchangeable for, or exercisable for the Company’s ordinary shares, for twelve months after the Janssen Closing Date and following such twelve month period, if they ever intend to sell the Company’s shares after the twelve month period, they will provide written notice to the Company at least five business days prior to taking any action. Eli Lilly and Company Collaboration Agreement On November 7, 2025 (the “Lilly 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 Lilly 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 Meira 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 Meira Ocular. Hologen Transactions On March 9, 2025 (the “Hologen Signing Date”), the Company and certain of its affiliates entered into a strategic collaboration with Hologen Limited, a non-cellular company limited by shares incorporated in Guernsey (“Hologen”), and certain of 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 entered into the Framework Agreements (as defined below), pursuant to which the Company and its affiliates would receive from Hologen an upfront cash payment of $200.0 million (the “Upfront Payment”), and Hologen would provide additional funding of up to an additional $230.0 million to finance the development of the Company’s 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, the Company also received an aggregate of 500,000 Class A shares of Hologen at a nominal price. As of March 31, 2026, Hologen made payments in the aggregate amount of $105.0 million to the Company as part of its commitment toward the Upfront Payment in advance of the closing of the transactions contemplated under the Framework Agreements. On the Hologen Signing Date, the Company, Meira 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 Completion (as defined under the Neuro Framework Agreement), the Company, Meira Neuro UK, Meira Neuro US, Hologen, Hologen Neuro and Hologen Neuro AI UK Limited, a private company limited by shares incorporated in England (“Hologen Neuro UK”), would 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. Also on the Hologen Signing Date, Meira Manufacturing, 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 Completion (as defined in the Manufacturing Framework Agreement), Hologen would acquire a minority interest in Meira Manufacturing, an entity that comprises the Company’s flexible and scalable end-to-end genetic medicines manufacturing business. Hologen would also contribute a portion of the annual funding to Meira Manufacturing. On April 2, 2026, the parties to the Framework Agreements entered into Amendment No. 1 to the Deed of Commitment Agreement (“Amendment to Commitment Agreement”) to agree, among other things, (i) to amend the Framework Agreements (A) to provide for additional conditions that must be met prior to Completion (as such term is defined under each of the Framework Agreements) relating to the allocation of the $105 million in payments Hologen previously made to the Company as part of its commitment toward the Upfront Payment as further described below, and (B) to provide that following Completion, Hologen shall fund the remaining portion of the Upfront Payment provided for under the Framework Agreements, and (ii) that Hologen would deploy any funds it raises to pay the remaining portion of the Upfront Payment. On April 20, 2026 (the “Hologen Initial Closing Date”), the Company and certain of its affiliates completed the initial closing of the strategic collaboration with Hologen and certain of its affiliates. Prior to the Hologen Initial Closing Date, Meira Neuro UK, Hologen Neuro and Hologen entered into a subscription agreement pursuant to which Meira Neuro UK subscribed for Class A shares in 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 Hologen subscribed for Class B shares in Hologen Neuro in consideration for a portion of the $105 million in payments Hologen previously made to the Company as part of its commitment toward the Upfront Payment. The Company then applied a portion of the $105 million in payments Hologen previously made to the Company equal to Hologen’s subscription price to satisfy the portion of the Upfront Payment due to Meira Neuro US under the Neuro Framework Agreement and Hologen Collaboration Agreement. On the Hologen Initial Closing Date, the parties to the Neuro Framework Agreement entered into an amendment to the Neuro Framework Agreement (the “Amendment to the Neuro Framework Agreement”) to, among other things, reflect the pre-closing issuance of the Hologen Neuro shares as additional conditions that needed to be met prior to Completion (as defined under the Neuro Framework Agreement) and to provide that, following Completion, Hologen shall fund the remaining portion of the Upfront Payment provided for under the Neuro Framework Agreement and the Hologen Collaboration Agreement by purchasing a portion of the Class A shares held by Meira Neuro UK, such that following the purchase, such Class A shares purchased by Hologen shall be converted to Class B shares and Hologen shall own 70% of the issued share capital of Hologen Neuro and Meira Neuro UK shall own 30% of the issued share capital of Hologen Neuro. Additionally, prior to the Hologen Initial Closing Date, MeiraGTx Limited and Hologen entered into a share purchase agreement pursuant to which Hologen purchased shares in Meira Manufacturing from MeiraGTx Limited in consideration for a portion of the $105 million in payments Hologen previously made to the Company as part of the Upfront Payment. On the Hologen Initial Closing Date, the parties to the Manufacturing Framework Agreement entered into an amendment to the Manufacturing Framework Agreement (the “Amendment to the Manufacturing Framework Agreement” and, together with the Amendment to the Neuro Framework Agreement, the “Amendments to the Framework Agreements”) to, among other things, reflect Hologen’s pre-closing purchase of the Meira Manufacturing shares as an additional condition that needed to be met prior to Completion (as defined under the Manufacturing Framework Agreement) and to provide that, following Completion, Hologen shall fund the remaining portion of the Upfront Payment provided for under the Manufacturing Framework Agreement by purchasing additional shares in Meira Manufacturing from MeiraGTx Limited (the “Additional Share Purchase”), such that following the Additional Share Purchase, Hologen will continue to own a minority interest in Meira Manufacturing. Under the Amendment to the Manufacturing Framework Agreement, the parties also agreed that (i) Hologen’s exclusive, irrevocable option to purchase additional shares in Meira Manufacturing at a specified price, such that following exercise of such option, Hologen would own up to a maximum of 40% of the issued share capital of Meira Manufacturing in the aggregate, shall be granted to Hologen on the closing date of the Additional Share Purchase and expire twelve months thereafter and (ii) the Company’s option to purchase all of the shares of Meira Manufacturing held by Hologen for the same price that Hologen paid for such shares if Hologen does not exercise its option begins on the third anniversary of the closing date of the Additional Share Purchase and ends three years thereafter. On the Hologen Initial Closing Date, the Company, Meira Neuro UK, Meira Neuro US, Hologen, Hologen Neuro and Hologen Neuro UK entered into the Hologen Collaboration Agreement, pursuant to which Meira Neuro US granted to Hologen Neuro and Hologen Neuro UK, subject to the license granted by Hologen Neuro and Hologen Neuro UK back to Meira 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. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain reclassifications of prior period activities have been made to conform to current year presentation. Interim Financial Statements The accompanying condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of management, the condensed consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary in order to make the condensed consolidated financial statements not misleading. Operating results for the three-month period ended March 31, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “Form 10-K”). Liquidity The Company has not yet achieved profitable operations. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of the Company’s product candidates will require significant additional financing. The Company’s accumulated deficit at March 31, 2026 totaled $862.5 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 and consummate transactions with collaborative partners; expanding and protecting the Company’s intellectual property portfolio; dependence on third parties; and dependence on key personnel. For the three months ended March 31, 2026, the Company had $17.8 million provided by cash flows from operations. 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 March 31, 2026, the Company had cash, cash equivalents and restricted cash in the amount of $73.8 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 and tax incentive receivable at March 31, 2026 together with the approximately $100.0 million gross proceeds from the public equity offering in the second quarter of 2026 will be sufficient to cover its expenses for at least the next twelve months from the date of issuance of these condensed consolidated financial statements, including the upfront payment to Janssen for the reacquisition of the RPGR Product and the repayment of the Company’s outstanding debt obligation of $25.0 million due in June 2026 as further described in Note 11. This estimate does not include the remaining $95.0 million Upfront Payment from Hologen or the $135.0 million in potential near-term cash consideration from Lilly upon achievement of certain development and regulatory approval milestones. ​ 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 11. 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.

X
- Definition The entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). + References Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 235 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 4 -Subparagraph (a) -Publisher FASB -URI https://asc.fasb.org/1943274/2147483426/235-10-50-4 Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 205 -Name Accounting Standards Codification -Publisher FASB -URI https://asc.fasb.org/205/tableOfContent + Details
Name: | us-gaap_BusinessDescriptionAndBasisOfPresentationTextBlock
Namespace Prefix: | us-gaap_
Data Type: | dtr-types:textBlockItemType
Balance Type: | na
Period Type: | duration

X
- References No definition available. + Details
Name: | us-gaap_OrganizationConsolidationAndPresentationOfFinancialStatementsAbstract
Namespace Prefix: | us-gaap_
Data Type: | xbrli:stringItemType
Balance Type: | na
Period Type: | duration