LONDON and NEW YORK, April 24, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced that Alexandria Forbes, Ph.D., President and Chief Executive Officer, will participate in the following investor conferences: Chardan 8th Annual Genetic Medicines and Cell Therapy Manufacturing Summit, Virtual Corporate presentation: Monday, April 29, 2024, at 11:00 a.m. ET  BofA Securities Healthcare Conference 2024, Las Vegas Corporate p ...

LONDON and NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company gave an oral presentation at the American Academy of Oral Medicine Annual Conference, being held from April 16-20, 2024, at the Hyatt Regency Grand Cypress in Orlando, FL. The details of the oral presentation are below: Session: Oral Abstract Session IPresentation ID #196Title: Results of a Phase 1, Open-label, Dose-escalation ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 (Exact name of registrant as specified in its charter) Cayman Islands 98-1448305 (State or other ...

Dr. Forbes continued, "In the area of ophthalmology, in the third quarter of 2023, we completed enrollment in the large multi-center Phase 3 study of bota-vec for XLRP- RPGR in collaboration with Janssen. Data from this global pivotal study is expected after the third quarter of 2024. Additionally, in the retinal disease space, we recently received data from our ongoing compassionate use program under a Specials License for children with LCA4 due to mutations in the AIPL1 gene. MeiraGTx developed and optimi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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 (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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 (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 ( ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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 (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 (State or other ju ...

Financial Performance - The company has incurred significant losses since inception and anticipates continued losses for the foreseeable future, with no assurance of achieving profitability[16]. - Net loss for 2022 was $129,615,000, compared to a net loss of $79,561,000 in 2021, indicating an increase in losses of about 62.9%[668]. - The Company's pre-tax loss for the year ended December 31, 2022, was $129,616,000, compared to a loss of $79,561,000 in 2021, representing a 62.8% increase[788]. - For the year ended December 31, 2022, the Company used $73.1 million in cash flows from operations, with no assurance of generating positive cash flows in the future[674]. - The Company has an accumulated deficit of $470.2 million as of December 31, 2022, and expects to incur substantial losses in future periods[674]. Revenue and Expenses - License revenue from related parties fell significantly from $37,701,000 in 2021 to $15,920,000 in 2022, a decrease of about 57.8%[668]. - Total operating expenses increased from $110,459,000 in 2021 to $132,275,000 in 2022, representing a rise of approximately 19.7%[668]. - Research and development expenses increased from $66,694,000 in 2021 to $85,725,000 in 2022, a rise of about 28.5%[668]. - The Company recognized collaboration revenue of $100.0 million from Janssen as a non-refundable upfront fee during the year ended December 31, 2019, and a milestone payment of $30.0 million in 2021[806]. - For the years ended December 31, 2022 and 2021, the Company recognized $15.9 million and $37.7 million, respectively, as license revenue from deferred revenue related to a related party[807]. Assets and Liabilities - Total assets decreased from $320,164,000 in 2021 to $318,237,000 in 2022, a decline of approximately 0.6%[666]. - Cash and cash equivalents decreased from $137,703,000 at the end of 2021 to $115,516,000 at the end of 2022, a reduction of approximately 16.1%[670]. - Total current liabilities rose from $68,128,000 in 2021 to $82,072,000 in 2022, an increase of about 20.5%[666]. - Shareholders' equity decreased from $185,401,000 in 2021 to $117,738,000 in 2022, a decline of approximately 36.5%[666]. - The company's long-lived assets totaled $163.9 million as of December 31, 2022, compared to $136.9 million in 2021, reflecting a growth of approximately 19.7%[754]. Capital and Financing - The annual interest rate on borrowings under the Note Purchase Agreement was 13.02% as of December 31, 2022, with an outstanding balance of $75.0 million[657]. - The outstanding balance of the Tranche 1 Notes was $75.0 million plus accrued interest of $4.0 million as of December 31, 2022, with an annual interest rate of 13.02%[828]. - The Note Purchase Agreement provides for an initial notes issuance of $75.0 million, with an option for an additional $25.0 million before August 2, 2024[828]. - The Company may seek additional capital through equity offerings, debt financings, and collaborations to support product development and commercialization[680]. - The Company raised approximately $25.0 million through a private placement of 3,742,514 ordinary shares at $6.68 per share on November 9, 2022[783]. Regulatory and Compliance Risks - The company is heavily dependent on the success of its Most Advanced Product Candidates, which are still in development, and failure to receive regulatory approval could harm the business[16]. - Compliance with privacy and data protection regulations is complex and costly, and failure to comply could materially harm the business[16]. - The Company operates in a highly competitive industry with significant risks, including uncertainty in product development and capital availability[678]. - The impact of the COVID-19 pandemic on the Company's financial position and operations remains uncertain, although it did not materially affect results in 2022[679]. Research and Development - The company has six programs in clinical development and a broad pipeline of preclinical and research programs, focusing on ocular diseases, neurodegenerative diseases, and severe forms of xerostomia[671]. - Research and development costs are charged to expense as incurred, including employee-related expenses and costs associated with clinical studies[740]. - The Company recorded reductions to research and development expenses of $6.8 million and $5.4 million for the years ended December 31, 2022, and 2021, respectively, related to tax incentive programs[689]. Tax and Deferred Tax - As of December 31, 2022, the Company had U.S. federal NOLs of $63,829,000 and UK carryforward tax losses of $187,939,000[11]. - The Company recorded deferred tax assets of $125,365,000 as of December 31, 2022, an increase from $100,340,000 in 2021[791]. - The Company has determined that it is more likely than not that its deferred tax assets will not be fully realized, resulting in a full valuation allowance[791]. - The UK corporation tax rate will increase from 19% to 25% effective April 1, 2023, impacting future accounting periods[792]. Share-Based Compensation - Share-based compensation expense for options was $16.1 million in 2022, compared to $14.8 million in 2021, representing an 8.8% increase[776]. - The total share-based compensation expense for RSUs was $12.5 million in 2022, significantly higher than $6.0 million in 2021, marking a 108.3% increase[780]. - The total compensation expense related to unvested options as of December 31, 2022, was $24.7 million, expected to be recognized over 4.0 years[778]. - The total compensation expense related to unvested RSUs as of December 31, 2022, was $26.9 million, expected to be recognized over 3.0 years[781].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION MeiraGTx Holdings plc WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 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 (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1448305 (State or othe ...

CONFIDENTIAL Corporate Presentation October 2022 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product development and anticipated milestones regarding our pre-clinical and clinical data and reporting ...