Multiple Poster Presentations Highlight the Depth and Novelty of MeiraGTx’s Technology Platforms for Gene and Cell TherapyLONDON and NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced the Company will exhibit four poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting, which is being held from May 13-17, 2025, in New Orleans, LA. The posters will be avai ...

Group 1 - MeiraGTx Holdings PLC reported a quarterly loss of $0.51 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.38, and an improvement from a loss of $0.77 per share a year ago, indicating a surprise of -34.21% [1] - The company generated revenues of $1.93 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 76.85%, compared to revenues of $0.7 million in the same quarter last year [2] - MeiraGTx shares have declined approximately 7.7% since the beginning of the year, while the S&P 500 has seen a decline of -0.6% [3] Group 2 - The earnings outlook for MeiraGTx is uncertain, but current consensus EPS estimates for the upcoming quarter are -$0.39 on revenues of $8.32 million, and -$0.09 on revenues of $126.94 million for the current fiscal year [7] - The Medical - Biomedical and Genetics industry, to which MeiraGTx belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable environment for stock performance [8]

Table of Contents ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38520 MeiraGTx Holdings plc UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 ...

Exhibit 99.1 MeiraGTx Reports First Quarter 2025 Financial and Operational Results - Announced strategic collaboration with Hologen AI, including a $200 million cash upfront payment to MeiraGTx and the formation of a joint venture, Hologen Neuro AI Ltd, with a further $230 million in capital committed to initially focus on expediting Phase 3 clinical development of AAV-GAD for Parkinson's disease - U.S. Food and Drug Administration (FDA) Granted Regenerative Medicine Advanced Therapy (RMAT) designation for ...

- This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson’s disease - RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated approval and Priority Review LONDON and NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage gen ...

Dublin, April 29, 2025 (GLOBE NEWSWIRE) -- The "Cone Rod Dystrophy Market: Analysis By Type, By Treatment Type, By End User, By Region Size and Trends - Forecast up to 2030" has been added to ResearchAndMarkets.com's offering. Cone rod dystrophy represents a group of genetic eye disorders impacting the retina's cone and rod cells. The market for treating this condition is witnessing substantial growth, projected to rise from a value of US$131.29 million in 2024 to US$177.59 million by 2030. This growth is ...

I used to cover MeiraGTx (NASDAQ: MGTX ) a few years ago, but haven’t looked at it since 2022. MGTX develops genetic therapies for ocular diseases, Parkinson’s Disease and xerostomia. Lead asset is AAV-AQP1 targeting Xerostomia in a pivotal phase 2About the TPT ServiceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated rese ...

Financial Performance - Total revenue for 2024 was $33,279,000, a significant increase from $14,017,000 in 2023, representing a growth of 137%[714] - Operating expenses increased to $197,491,000 in 2024 from $151,078,000 in 2023, marking a rise of 30.7%[714] - The net loss for 2024 was $147,791,000, compared to a net loss of $84,027,000 in 2023, indicating a 75.9% increase in losses[714] - Cash and cash equivalents decreased to $103,659,000 in 2024 from $129,566,000 in 2023, reflecting a decline of 20%[713] - Total current assets fell to $123,518,000 in 2024, down from $159,622,000 in 2023, a decrease of 22.6%[713] - Total liabilities increased to $201,924,000 in 2024 from $188,567,000 in 2023, an increase of 7.1%[713] - Shareholders' equity decreased significantly to $67,827,000 in 2024 from $138,177,000 in 2023, a decline of 50.9%[713] - The company reported a basic and diluted net loss per ordinary share of $2.12 for 2024, compared to $1.49 for 2023[714] - The segment net loss for 2024 was $147,791,000, compared to a net loss of $84,027,000 in 2023, indicating a worsening financial performance[814] Capital and Funding - The company requires additional capital to fund operations, which may not be available on acceptable terms[14] - The Company’s capital resources have been primarily funded through collaboration agreements and equity offerings[727] - The Company raised gross proceeds of $8.4 million through the sale of 1,508,517 ordinary shares under the "at-the-market" equity offering program during the year ended December 31, 2024[842] - The Company completed a public offering of 12,500,000 ordinary shares at a price of $4.00 per share, resulting in gross proceeds of $50.0 million on August 12, 2024[843] Research and Development - The company is heavily dependent on the success of its product candidates, which are still in development, and if none receive regulatory approval, the business may be harmed[14] - Clinical trials are expensive and time-consuming, with uncertain outcomes, and the company may encounter substantial delays[14] - 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 services performed[795] - Research and development costs are charged to expense as incurred, including employee-related expenses and costs associated with clinical studies[800] - The Company recorded reductions to research and development expenses of $5.5 million and $5.1 million for the years ended December 31, 2024 and 2023, respectively, related to tax incentive programs[736] Regulatory and Compliance - The company is subject to significant regulation regarding the manufacturing of its products, and its manufacturing facilities may not continue to meet regulatory requirements[14] - The Company has not recognized a provision for obsolete and excess inventory as of December 31, 2024[734] Competition and Market Environment - The company faces significant competition in a rapidly changing technological environment, which may affect its financial condition and ability to market its product candidates[21] - The company depends on proprietary technology licensed from others, and losing these licenses could hinder its ability to develop product candidates[21] Tax and Deferred Tax - The Company recorded unrecognized tax positions of $2.2 million and $2.0 million as of December 31, 2024 and 2023, respectively[805] - The Company has recorded a full valuation allowance against its deferred tax assets, indicating management's assessment that it is more likely than not that these assets will not be fully realized[852] - The Company recorded a deferred tax asset of $155.2 million as of December 31, 2024, compared to $130.3 million in 2023, primarily due to net operating loss carryforwards increasing from $70.7 million to $85.3 million[852] - The total deferred tax expense for the Company was $24.0 million in 2024, compared to $9.7 million in 2023, reflecting a significant increase in deferred tax liabilities[852] Collaboration Agreements - The Company received a non-refundable upfront cash payment of $65.0 million from Janssen in December 2023 under the Asset Purchase Agreement[720] - Janssen agreed to pay future contingent consideration of up to $350.0 million, including milestone payments of $50.0 million for initiating a Phase 3 clinical trial and $175.0 million upon the first commercial sale of the RPGR Product in the U.S.[720] - Under the Collaboration Agreement with Johnson & Johnson Innovative Medicine, the Company received a non-refundable upfront fee of $100.0 million and a milestone payment of $30.0 million in December 2021[856] Asset Management - Long-lived assets decreased from $157,356,000 in 2023 to $136,473,000 in 2024, with notable declines in assets located in the United States and the European Union[816] - The balance of asset retirement obligations increased from $2,401,000 in 2023 to $2,821,000 in 2024, reflecting a change in estimate of $345,000[763] Share-Based Compensation - The total share-based compensation expense for the year ended December 31, 2024, was $25.2 million, a decrease from $27.7 million in 2023[841] - The total compensation expense related to unvested options as of December 31, 2024, was $8.5 million, expected to be recognized over 3.2 years[836] - The total compensation expense related to unvested RSUs as of December 31, 2024, was $21.9 million, expected to be recognized over 3.3 years[839] - The Company recorded share-based compensation expense of $15.2 million for RSUs in 2024, compared to $14.1 million in 2023[838] Revenue Recognition - The Company recognizes revenue based on the control of promised goods or services, following ASC 606, and evaluates performance obligations to determine revenue recognition[782] - The Company recognizes revenues from nonrefundable, up-front fees allocated to licenses when the license is transferred and the licensee can benefit from it[792] - The Company’s collaboration revenue is recognized using the cost-to-cost input method under ASC 606, reflecting the progress towards completion of performance obligations[864] - The company recognized $33.3 million of service revenue during the year ended December 31, 2024, which included $14.0 million of deferred revenue recognized as service revenue[876]

Exhibit 99.2 MeiraGTx Reports Fourth Quarter and Full Year 2024 Financial and Operational Results and Recent Business Updates LONDON and NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the fourth quarter and full-year ended December 31, 2024, and provided a corporate update. "MeiraGTx demonstrated excellent execution in 2024, marked by significant advanc ...

Core Viewpoint - MeiraGTx announced a strategic collaboration with Hologen AI, involving a $200 million upfront payment and the formation of a joint venture, Hologen Neuro AI Ltd, aimed at advancing the development of therapies for neurodegenerative diseases, particularly Parkinson's disease [1][2] Recent Developments - The joint venture will focus on the Phase 3 clinical development of AAV-GAD for Parkinson's disease, with an additional $230 million committed by Hologen [1][2] - MeiraGTx reported positive results from a clinical study of AAV-GAD, showing significant improvements in the Unified Parkinson's Disease Rating Scale (UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39) [1][8] - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for AAV2-hAQP1 for treating Grade 2/3 radiation-induced xerostomia (RIX) [1][8] Clinical and Regulatory Milestones - MeiraGTx achieved FDA Rare Pediatric Disease Designations for four therapies targeting rare inherited retinal diseases, including rAAV8.hRKp.AIPL1 for LCA4 [3] - The company plans to submit a Marketing Authorization Application (MAA) for rAAV8.hRKp.AIPL1 based on exceptional clinical results observed in children [4][14] Financial Overview - As of December 31, 2024, MeiraGTx reported cash and cash equivalents of approximately $103.7 million, with expectations to fund operations into 2027 [19] - The company experienced a net loss of $147.8 million for the year ended December 31, 2024, compared to a net loss of $84.0 million in 2023 [32][39] - Service revenue for 2024 was $33.3 million, a significant increase from zero in 2023, attributed to process performance qualification services [24][26] Manufacturing and Regulatory Compliance - MeiraGTx's UK manufacturing facility received successful GMP compliance renewal, supporting its application for a commercial MIA license [16] - The Shannon facility in Ireland obtained additional licenses for GMP viral vector manufacturing, marking a significant milestone for gene therapy in the region [18] Strategic Partnerships - The collaboration with Hologen AI is expected to enhance the efficiency and success probability of MeiraGTx's clinical programs through the application of advanced AI technologies [2][8] - Sanofi's strategic investment of $30 million in MeiraGTx provides additional financial backing and a right of first negotiation for certain therapeutic targets [23]