Core Viewpoint - MeiraGTx Holdings plc has announced an underwritten offering of 12,500,000 ordinary shares at a price of $4.00 per share, aiming to raise gross proceeds of $50 million before expenses [1][2]. Group 1: Offering Details - The offering is led by Sanofi, which invested $30 million in MeiraGTx through this offering [2]. - Other participants include Perceptive Advisors and various institutional healthcare funds [2]. - BofA Securities is acting as the sole underwriter for the offering, which is expected to close around August 13, 2024, pending customary closing conditions [2]. Group 2: Regulatory Information - The ordinary shares are being offered under an effective shelf registration statement on Form S-3, filed with the SEC on December 21, 2023, and declared effective on December 29, 2023 [3]. - The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC [3].

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Ordinary Shares, $0.00003881 par value per share MGTX The Nasdaq Global Select Market 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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For th ...

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 March 31, 2024 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 ...

Exhibit 99.1 MeiraGTx Reports First Quarter 2024 Financial and Operational Results - Positive data from the Phase 1 AQUAx study in radiation-induced xerostomia (RIX) presented in an oral session at the American Academy of Oral Medicine 2024 annual meeting (AAOM) April 17-20, 2024 - Received $50 million milestone following initiation of the extension study for the Phase 3 LUMEOS clinical trial for botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for the treatment of X-linked retinitis pigmentosa (XLR ...

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 ...

Financial Performance - The company has incurred significant losses since inception and anticipates continued losses for the foreseeable future, with no guarantee of achieving profitability[16]. - The net loss for 2023 was $84,027,000, an improvement from a net loss of $129,615,000 in 2022, reflecting a reduction of 35.2%[688]. - The company's pre-tax loss for 2023 was $84,027 million, an improvement from a loss of $129,615 million in 2022[812]. - The Company reported a gain on the sale of nonfinancial assets amounting to $54,208,000 in 2023[688]. - The Company recorded basic and diluted net loss per ordinary share as the same due to anti-dilutive effects of additional ordinary share equivalents[774]. Revenue and Income - The company recognized deferred revenue of $36.9 million and a gain on the sale of non-financial assets amounting to $54.2 million as of December 31, 2023, due to agreements with Janssen Pharmaceuticals[681]. - The company recognized $70.4 million and $73.3 million related to the reimbursement of research and development expenses under the collaboration agreement for the years ended December 31, 2023, and 2022, respectively[834]. - The collaboration agreement with Janssen includes a 20% royalty on net sales of products and additional milestones up to $340.0 million[822]. - The Company received a non-refundable upfront cash payment of $65.0 million from Janssen Pharmaceuticals in December 2023 as part of an Asset Purchase Agreement[696]. - The Company received a non-refundable upfront fee of $100.0 million from Janssen under a collaboration agreement for gene therapies[819]. Assets and Liabilities - Total current assets increased to $159,622,000 in 2023 from $154,339,000 in 2022, representing a growth of 3.3%[687]. - The company’s total liabilities decreased to $188,567,000 in 2023 from $200,499,000 in 2022, a reduction of 5.9%[687]. - Cash and cash equivalents at the end of 2023 were $129,566,000, up from $115,516,000 at the end of 2022, indicating an increase of 12.1%[687]. - The Company recorded unrecognized tax positions of $2.0 million, up from $0.9 million in 2022[772]. - The balance of asset retirement obligations increased from $2,179,000 in 2022 to $2,401,000 in 2023, reflecting amortization of interest and exchange rate changes[734]. Expenses - Total operating expenses rose to $151,078,000 in 2023, compared to $132,275,000 in 2022, marking an increase of 14.2%[688]. - The Company recorded depreciation and amortization expense of $12,300,000 in 2023, up from $7,300,000 in 2022, marking an increase of approximately 68.8%[790]. - The total compensation expense related to unvested options as of December 31, 2023, was $18.3 million, expected to be recognized over 3.7 years[800]. - Total share-based compensation expense for 2023 was $27.716 million, a decrease of 3.2% from $28.623 million in 2022[804]. - The total rent expense recorded under leases was $5.5 million for the year ended December 31, 2023, compared to $5.3 million for 2022[839]. Cash Flow - The company’s cash flows from operating activities showed a net cash used of $105,365,000 in 2023, compared to $73,098,000 in 2022, indicating an increase in cash outflow[693]. - For the year ended December 31, 2023, the Company used $105.4 million in cash flows from operations, with no assurances of generating positive cash flows in the future[699]. - As of December 31, 2023, the Company had cash, cash equivalents, and restricted cash totaling $130.6 million, which is expected to cover expenses for at least the next twelve months[700]. Capital and Financing - The annual interest rate on borrowings under the Notes Purchase Agreement was 15.32% as of December 31, 2023, with an outstanding balance of $75.0 million[669]. - A hypothetical 1% increase in the secured overnight financing rate (SOFR) would increase annual interest expense by approximately $0.8 million for the year ended December 31, 2023[669]. - The outstanding balance of the Tranche 1 Notes was $75.0 million plus accrued interest of $3.0 million as of December 31, 2023[848]. - The Company recorded interest expense of $11.3 million for the year ended December 31, 2023, compared to $4.0 million for 2022[848]. - The Notes Purchase Agreement matures on August 2, 2026, and is interest-only during the term[848]. 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[16]. - Clinical trials are expensive and time-consuming, with potential delays that could impact the company's operations[16]. - The Company recorded reductions to research and development expenses of $2.9 million and $6.8 million for the years ended December 31, 2023 and 2022, respectively, related to UK tax incentive programs[709]. - Research and development costs are charged to expense as incurred, including employee-related expenses and costs associated with clinical studies[767]. - The Company is focusing on developing a riboswitch platform for metabolic peptides and cell therapy for oncology and autoimmune diseases[694]. Regulatory and Market Risks - The company faces significant competition in a rapidly changing technological environment, which may affect its financial condition and ability to market products[23]. - The affected populations for the company's product candidates may be smaller than projected, impacting the addressable markets[16]. - The Company is subject to significant risks, including competition, regulatory challenges, and reliance on third parties for its operations[701]. - The UK corporation tax rate will increase from 19% to 25% effective April 1, 2023, impacting future accounting periods[815]. Shareholder and Equity Information - Shareholders' equity increased to $138,177,000 in 2023 from $117,738,000 in 2022, a rise of 17.3%[687]. - The total number of options outstanding increased from 6,858,409 in 2022 to 8,226,707 in 2023, a rise of about 20%[797]. - The weighted average grant date fair value of options granted in 2023 was $5.67, significantly lower than $12.81 in 2022[799]. - The Company issued 10,773,913 ordinary shares in a private placement in May 2023, raising approximately $62.0 million[807]. - In October 2023, the company issued 4,000,000 ordinary shares to Sanofi for gross proceeds of $30.0 million[808].

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 ( ...